CN220558082U

CN220558082U - System for ablating endometrial tissue of a patient

Info

Publication number: CN220558082U
Application number: CN202190000917.5U
Authority: CN
Inventors: V·K·夏尔马; G·W·伯恩
Original assignee: Santa Anna Tech LLC
Current assignee: Santa Anna Tech LLC
Priority date: 2020-10-08
Filing date: 2021-10-07
Publication date: 2024-03-08
Anticipated expiration: 2031-10-07

Abstract

The present utility model relates to a system for ablating endometrial tissue of a patient. An ablation catheter and system in accordance with the present utility model includes a catheter tip having at least one hollow needle that can extend from a catheter body at an angle to ablate target prostate tissue while avoiding structures in areas near the prostate tissue, including the urethra, ejaculatory duct, and rectal wall. The steam ablation system has a pump, a catheter including a connection port positioned on a proximal end of the catheter, a lumen in fluid communication with the connection port and configured to receive saline from the pump via the connection port, at least one electrode positioned within the lumen, and at least two positioning elements having a lumen with a steam port therebetween and configured to be coupled to a distal tip of the catheter. Embodiments describe catheter handle mechanisms that provide an ergonomic method for manipulating and using a catheter.

Description

System for ablating endometrial tissue of a patient

Cross reference

The priority of this application depends on U.S. patent provisional application No. 63/210,523 entitled "Systems and Methods for Ablating Tissue" filed on day 15 of 6 of 2021 and U.S. patent provisional application No. 63/089,450 entitled "Systems and Methods for Ablating Tissue" filed on day 8 of 10 of 2020.

The present application continues in part from U.S. patent application Ser. No. 17/005,982, entitled "Systems and Methods for Ablating Prostate Tissue", filed 8/28 in 2020, and its priority is dependent upon U.S. patent provisional application Ser. No. 63/025,867, entitled "Systems and Methods for Genitourinary Ablation", filed 15 in 2020, and U.S. patent provisional application Ser. No. 62/953,116, entitled "Systems and Methods for Prostate and Endometrial Ablation", filed 12/23 in 2019, and U.S. patent provisional application Ser. No. 62/893,062, entitled "28 in 2019.

The present application relates to U.S. patent application Ser. No. 15/600,670, entitled "Ablation Catheter with Integrated Cooling", filed on day 5, month 19, 2017, which relies on U.S. provisional patent application Ser. No. 62/425,144, entitled "Methods and Systems for Ablation", filed on day 11, month 22, 2016, and U.S. provisional patent application Ser. No. 62/338,871, entitled "Cooled Coaxial Ablation Catheter", filed on day 5, month 19, as priorities.

U.S. patent application Ser. No. 15/600,670 is also filed on 5/2/2017 and issued on 4/9/2018 as part of U.S. patent application Ser. No. 15/144,768 entitled "instruction-Based Micro-Volume Heating System" of U.S. patent application Ser. No. 10,064,697, and U.S. patent application Ser. No. 15/144,768 is filed on 1/12/2015 and issued on 7/2/2017 as part of U.S. patent application Ser. No. 14/594,444 entitled "Method and Apparatus for Tissue Ablation" of U.S. patent application Ser. No. 9,561,068, and U.S. patent application Ser. No. 14/594,444 is part of U.S. patent application Ser. No. 14/158,687. The present application claims priority from U.S. patent application No. 9,561,067, filed on 1 month 17 of 2014, and issued as U.S. patent No. 9,561,067 on 7 month 2 of 2017, which in turn depends on U.S. provisional patent application No. 61/753,831, filed on 17 of 2013, filed on 17 of same title.

U.S. patent application No. 14/158,687 is also part of U.S. patent application No. 13/486,980 entitled "Method and Apparatus for Tissue Ablation (method and apparatus for tissue ablation)" filed on 1, 6, 2012, and issued as U.S. patent No. 9,561,066, 2, 7, 2017, which in turn relies on the same title of U.S. provisional patent application No. 61/493,344 filed on 3, 6, 2011 as a priority.

U.S. patent application Ser. No. 13/486,980 is also a continuation of the section entitled "Method and Apparatus for Tissue Ablation" U.S. patent application Ser. No. 12/573,939 filed on 6 th 10 th 2009, the priority of which in turn depends on U.S. provisional patent application Ser. No. 61/102,885 filed on 6 th 2008, which is filed on even title.

All of the above-referenced applications are incorporated by reference in their entirety.

Technical Field

The present specification relates to systems and methods configured to generate and deliver steam for ablation therapy. More particularly, the present description relates to systems and methods including a handle mechanism for a steam ablation catheter.

Background

Benign Prostatic Hyperplasia (BPH) refers to enlargement of the prostate. The enlargement may be noncancerous and is common in men as they age. However, enlargement of the prostate due to BPH may cause urethral compression, thereby impeding urine flow from the bladder through the urethra. Anatomically, the medial and lateral lobes are often enlarged due to their high glandular composition. The anterior leaflet has little glandular tissue and is rarely enlarged. Prostate cancer usually occurs in the posterior leaflet, thus enabling the discrimination of irregular contours in each rectal examination.

The earliest microscopic signs of BPH generally began in the periurethral region (PuZ) between men aged 30 and 50 years, which was posterior to the proximal urethra. In BPH, most of the growth occurs in the Transition Zone (TZ) of the prostate. In addition to these two classical regions, the Peripheral Zone (PZ) is also involved to a lesser extent. Prostate cancer usually occurs at PZ. However, BPH nodules typically from TZ are typically biopsied in any way to exclude cancer in TZ. BPH is nodular hyperplasia rather than diffuse hyperplasia, affecting the TZ and PuZs of the prostate. In clinical disease, adenomas from TZ form the lateral leaves, while adenomas from PuZ form the medial leaves.

Transurethral needle ablation (TUNA) is a procedure for treating symptoms caused by BPH. Ablation surgery is used to treat additional prostate tissue that causes symptoms of BPH.

About 8% of men between 50 and 70 years old are diagnosed with prostate cancer and, with age, tend to develop prostate cancer in men. Men experiencing symptoms of prostate cancer often exhibit symptoms similar to BPH and may also suffer from sexual problems caused by the disease. In general, men diagnosed with prostate cancer have a very good prognosis when the cancer is in an early stage. Depending on the severity of the disease and the age of the patient, treatment ranges from active monitoring to surgery and radiation and chemotherapy.

Dysfunctional Uterine Bleeding (DUB) or menorrhagia affects 30% of women of childbearing age. The associated symptoms have a considerable impact on the health and quality of life of women. The condition is typically treated with an endometriectomy or hysterectomy. The surgical intervention rate for these women is high. In the united states, nearly 30% of women will undergo hysterectomy before age 60, with menorrhagia or DUBs being the cause of surgery in 50-70% of these women. Endometrial ablation technology has been approved by the FDA for women with abnormal uterine bleeding and intrawall fibroids with dimensions less than 2 cm. The presence of submucosal uterine fibroids and large uterine sizes has been shown to reduce the efficacy of standard endometrial ablation. Of the five FDA-approved global ablation devices (i.e., thermachoice, hydrothermal ablation, novassure, her Option, and microwave ablation (MEA)), only microwave ablation has been approved for submucosal fibroids less than 3cm in size and without occluding the endometrial cavity, and additionally for large uterus of up to 14cm in width.

Bladder cancer is a rare form of cancer that occurs due to abnormal growth of cells within the bladder. Abnormal cells form tumors. Fig. 22A shows stages of bladder cancer 2200 as known in the medical arts. Referring to the figure, in a first stage (Tis), a bladder tumor 2202 is above a layer of mucosa 2204 within the bladder 2200. In the second stage (Ta), tumor 2206 spreads to mucosa 2204. In the third stage (T1), tumor 2208 spreads to submucosa 2210 below mucosa 2204. In the fourth stage (T2), the tumor 2212 spreads to the superficial muscles 2214 below the submucosa 2210. In the fifth stage (T3 a), the tumor 2216 spreads to the deep muscle 2218 below the superficial muscle 2214. In the sixth stage (T3 b), tumor 2220 spreads to perivesicular fat layer 2222 beyond deep muscle 2218. In the seventh stage (T4 b), tumor 2224 spreads to the area outside peri-bladder fat layer 2222. In the eighth stage (T4 a), tumor 2226 diffuses to the outward protruding structures 2228 outside of bladder 2200. Ablation techniques may be used to treat cancers of the first through fourth stages, which are non-muscle invasive or superficial bladder cancers. Furthermore, ablative techniques can be used to reduce cancers from the fifth to fifth stage, which are invasive bladder cancers.

The function of the bladder is to hold urine that is produced in the kidneys and travels down to the bladder through a tube called the ureter. Urine leaves the bladder and enters the urethra, which in turn discharges the urine out of the body. Some individuals suffer from overactive bladder (OAB), which results in impulses that cause urination multiple times a day even when the bladder is not full. Ablation techniques may be used to treat OAB patients.

Since the bladder is intended to contain urine, in the presence of urine on the tissue to be ablated, steam from the ablation procedure may be ineffective. It is therefore desirable to provide a method of ablating bladder tissue after completely removing fluid, water, and/or urine from the target tissue.

Ablation in connection with the present specification relates to the removal or destruction of body tissue by the introduction of destructive agents (e.g., radiofrequency energy, laser energy, ultrasound energy, refrigerants or vapors). Ablation is commonly used to eliminate diseased or unwanted tissue such as, but not limited to, cysts, polyps, tumors, hemorrhoids, and other similar lesions. Ablation techniques may be used in combination with chemotherapy, radiation, surgery, and BCG vaccine therapy.

Vapor-based ablation systems, such as those disclosed in U.S. patent nos. 9,615,875, 9,433,457, 9,376,497, 9,561,068, 9,561,067, and 9,561,066, disclose an ablation system that controllably delivers vapor through one or more lumens toward a tissue target. One problem with all such vapor-based ablation systems is potential overheating or burning of healthy tissue. The vapor passing through the channel within the body cavity heats the surface of the channel and may cause the outer surface of the medical tool (except the working tool end itself) to become overheated. Thus, when an external portion of the device other than the distal operating end of the tool accidentally contacts healthy tissue, the physician may inadvertently burn the healthy tissue. U.S. patent nos. 9,561,068, 9,561,067 and 9,561,066 are incorporated herein by reference.

It is desirable to have a vapor-based ablation device that integrates a safety mechanism into the device itself that prevents unwanted ablation during use. It is also desirable to have a catheter handle that allows a user to ergonomically grasp the device during steam ablation therapy. Finally, it is desirable to provide a device holding and manipulation mechanism for one-handed use.

Disclosure of Invention

The present specification discloses an ablation catheter (ablation catheter) configured to deliver an ablation fluid to at least one of a volume of prostate tissue or a volume of fibrotic tissue, the ablation catheter comprising: a sheath (shaping) having at least one lumen (lumen), wherein the lumen is configured to receive a volume of fluid; at least one needle positioned within a distal tip of the catheter and configured to deploy from a surface of the distal tip; at least one port positioned in the at least one needle; at least one heating component positioned within the lumen and proximate to the distal tip, wherein the at least one heating component is configured to receive the volume of fluid; a handle coupled to a proximal end of the sheath; a camera positioned near the distal tip and configured to visually capture movement and position of the at least one needle as the at least one needle protrudes from the surface of the distal tip; a light source positioned proximate to the camera, wherein the camera and the light source are physically coupled into the sheath; and an optical data transmission circuit coupled to the camera, wherein a value defining a maximum diameter of the catheter is less than or equal to 8mm.

Optionally, the at least one heating element is a flat electrode.

Optionally, the at least one needle is configured to be deployed at an angle (translated) relative to a longitudinal axis defining a direction of the distal tip. The angle may be in the range of 10 degrees to 90 degrees relative to a longitudinal axis defining the direction of the distal tip.

Optionally, the camera and the light source are not located in a mirror that is physically separate from the sheath.

Alternatively, the maximum diameter of the catheter is in the range of 4mm to 6 mm.

Optionally, the at least one heating component comprises an electrode, wherein the electrode is tapered such that a distal tip of the electrode is thinner than a proximal portion of the electrode.

Optionally, the fluid is brine.

Optionally, the sheath includes a second lumen extending parallel to the at least one lumen, wherein the optical data transmission circuit is located within the second lumen.

The present specification also discloses an ablation system configured to deliver an ablative fluid to at least one of a volume of prostate tissue or a volume of fibrotic tissue, the ablation system comprising: a catheter, the catheter having: a sheath having at least one lumen, wherein the lumen is configured to receive a volume of fluid; at least one needle positioned within a distal tip of the catheter and configured to deploy from a surface of the distal tip; at least one port positioned in the at least one needle; at least one heating component positioned within the lumen and proximate to the distal tip, wherein the at least one heating component is configured to receive the volume of fluid; a handle coupled to a proximal end of the sheath; a camera positioned near the distal tip and configured to visually capture movement and position of the at least one needle as the at least one needle protrudes from the surface of the distal tip; a light source positioned proximate to the camera, wherein the camera and the light source are physically coupled to the sheath; and an optical data transmission circuit coupled to the camera, wherein a value defining a maximum diameter of the catheter is less than or equal to 8mm; a fluid reservoir configured to hold the volume of fluid and coupled to the at least one lumen; a pump in pressure communication with the fluid reservoir; and a controller coupled to the pump, wherein the controller is in electrical communication with the at least one heating component and is programmed to deliver electrical current to the at least one heating component and when activated, cause the volume of fluid to enter the lumen from the fluid reservoir.

Optionally, the ablation system further comprises a power source positioned in the controller and coupled to the light source and the camera.

Optionally, the at least one heating element is a flat electrode.

Optionally, the at least one needle is configured to be deployed at an angle relative to a longitudinal axis defining a direction of the distal tip. The angle may be in the range of 10 degrees to 90 degrees relative to a longitudinal axis defining the direction of the distal tip.

Optionally, the at least one heating component is an electrode, wherein the electrode is tapered such that a distal tip of the electrode is thinner than a proximal portion of the electrode.

Optionally, the controller is programmed to deliver current to the at least one heating element for a continuous period of time less than or equal to one minute.

Optionally, the sheath includes a second lumen extending parallel to the at least one lumen, wherein the optical data transmission circuit is located within the second lumen. Optionally, the second lumen has a diameter of less than or equal to 4mm and the at least one lumen has a diameter of less than or equal to 4 mm.

The present specification also discloses a handle mechanism for a catheter device for ablating patient tissue, the handle mechanism comprising: an elongate tubular structure comprising a proximal end and a distal end; a catheter shaft extending through the tubular structure and extending from a distal end of the tubular structure; at least two positioning elements positioned inside the catheter shaft, wherein the positioning elements are configured to be coupled to a distal tip of the catheter shaft, the at least two positioning elements comprising: a proximal positioning element positioned at a distal tip of the catheter shaft; and a distal positioning element positioned distally of the proximal positioning element; at least one aperture configured between the at least two positioning elements, wherein the at least one aperture is configured to provide an outlet for vapor for ablating the patient tissue; a button comprising a safety feature, wherein the button, when activated, initiates generation of vapor for ablation through the at least one aperture; a first controller attached to the catheter shaft, the first controller configured to perform at least one of linear advancement and retraction of the proximal positioning element; a second control attached to the catheter shaft, the second control configured to perform at least one of linear advancement and retraction of the distally located element; a third control attached to the catheter shaft, the third control configured to fix the position of the proximal positioning element and the distal positioning element; and an indicator for showing the degree of separation between the proximal and distal positioning elements.

Optionally, the catheter shaft comprises an inner catheter coaxially positioned within the catheter shaft. Optionally, at least two positioning elements are configured to face the distal portion of the inner catheter. Optionally, the at least one aperture is configured on the inner catheter.

Alternatively, the handle mechanism may be operated with a single hand.

Optionally, the button, the first control, the second control, the third control, and the indicator are disposed on a first lateral side of the handle mechanism.

Optionally, the button is at least one of a push button, a slide button, or a swivel wheel.

Optionally, the first control and the second control are parallel to each other.

Optionally, the second control surrounds the first control.

Optionally, the indicator comprises a scale having indicia visible through the window, wherein the indicia is aligned with at least one arrow outside the window to show the degree of separation between the proximal and distal positioning elements.

Optionally, each of the first control and the second control comprises at least one of a slider, a pressed lever, a trigger arm, a toggle button, and a combination of directional buttons, wherein each button indicates a direction of linear movement of the at least two positioning elements.

Optionally, the third control comprises at least one of a rotary lever, a knob, a toggle button, a push button.

Optionally, the handle mechanism further comprises a strain relief at a distal end on a portion of the catheter shaft.

Optionally, the handle mechanism further comprises a fluid line extending from the proximal end and in axial fluid communication with the catheter tube. Optionally, the handle mechanism further comprises a power line extending from the proximal end and at least one electrode in the proximal portion of the catheter shaft, wherein the power line is in electrical communication with the at least one electrode and is configured to provide an electrical current to the electrode. Optionally, the handle mechanism further comprises a strain relief positioned at the proximal end over a portion of the fluid line and the power line.

The present specification also discloses a handle mechanism for a catheter device for ablating patient tissue, comprising: a structure comprising two portions, wherein a first portion is rotatable to angle the first portion relative to a second portion, and comprises a proximal end and a distal end; a catheter shaft extending through the structure and extending from a distal end of the structure; at least two positioning elements positioned inside the catheter shaft, wherein the positioning elements are configured to be coupled to a distal tip of the catheter shaft, the at least two positioning elements comprising: a proximal positioning element positioned at a distal tip of the catheter shaft; and a distal positioning element positioned distally of the proximal positioning element; at least one aperture configured between the at least two positioning elements, wherein the at least one aperture is configured to provide an outlet for vapor for ablating the patient tissue; a button comprising a safety feature, wherein the button, when activated, initiates generation of vapor for ablation through the at least one aperture; a first controller attached to the catheter shaft, the first controller configured to perform at least one of linear advancement and retraction of the proximal positioning element; a second control attached to the catheter shaft, the second control configured to perform at least one of linear advancement and retraction of the distally located element; a third control attached to the catheter shaft, the third control configured to fix the position of the proximal positioning element and the distal positioning element; and an indicator for showing the degree of separation between the proximal and distal positioning elements.

Alternatively, the angle is in the range of 0 degrees and 180 degrees.

Optionally, the handle mechanism further comprises a button to enable and disable rotation of the first portion relative to the second portion.

The present specification also discloses a handle mechanism for a catheter device for ablating patient tissue, the handle mechanism comprising: an elongated planar structure comprising a proximal end and a distal end; a catheter shaft extending through the structure and extending from a distal end of the structure; at least two positioning elements positioned inside the catheter shaft, wherein the positioning elements are configured to be coupled to a distal tip of the catheter shaft, the at least two positioning elements comprising: a proximal positioning element positioned at a distal tip of the catheter shaft; and a distal positioning element positioned distally of the proximal positioning element; at least one aperture configured between the at least two positioning elements, wherein the at least one aperture is configured to provide an outlet for vapor for ablating the patient tissue; a button comprising a safety feature, wherein the button, when activated, initiates generation of vapor for ablation through the at least one aperture; a first control attached to the catheter shaft, the first control configured to incrementally perform at least one of linear advancement and retraction of the proximally located element, wherein a position of the proximally located element is fixed when the first control is stationary; a second control attached to the catheter shaft, the second control configured to incrementally perform at least one of linear advancement and retraction of the distally located element, wherein a position of the distally located element is fixed when the second control is stationary; and a scale having indicia adjacent each of the first control and the second control to indicate the extent of advancement and retraction of the proximal positioning element and the distal positioning element.

The present specification discloses a handle mechanism for a catheter device for ablating patient tissue, the handle mechanism comprising: an elongate tubular structure comprising a proximal end and a distal end; a catheter shaft extending through the tubular structure and extending from a distal end of the tubular structure; at least one thermally conductive elongate element positioned inside the catheter shaft, wherein the thermally conductive element is configured to be coupled to a distal tip of the catheter shaft; a button comprising a safety feature, wherein the button, when activated, initiates generation of vapor for ablation by the at least one thermally conductive element; a first control attached to the catheter shaft, the first control configured to perform at least one of linear advancement and retraction of the at least one thermally conductive element when actuated; and a second control attached to the catheter shaft and the at least one thermally conductive element configured to cause rotation of the thermally conductive element when actuated.

Optionally, the at least one thermally conductive elongate element is a needle.

The handle mechanism may be operated with a single hand.

Optionally, the first control comprises an incremental control for advancing the at least one thermally conductive element.

Optionally, the first control is configured to retract the at least one thermally conductive element immediately upon actuation.

Optionally, the first control comprises at least one of a slider, a pressed lever, a trigger arm, a switch button, and a combination of directional buttons, wherein each button indicates a direction of linear movement of the at least one thermally conductive element.

Optionally, the second control comprises at least one of a rotator wheel, a knob, or a combination of directionally pressing buttons, wherein each button indicates a direction of rotation of the at least one thermally conductive element.

Optionally, the handle mechanism further comprises a groove along the elongated tubular structure for ergonomic gripping.

Optionally, the handle mechanism further comprises a first marker showing a unit of distance traveled by the at least one thermally conductive element when the first control is used. The indicia may include tactile feedback.

Optionally, the handle mechanism further comprises a second marker showing the angular unit rotated by the at least one thermally conductive element when the second control is used.

The present specification also discloses a handle mechanism for a catheter device for ablating patient tissue, comprising: an angled structure comprising two portions, wherein a first portion is angled relative to a second portion and comprises a proximal end and a distal end; a catheter shaft extending through the angular structure and extending from the distal end; at least one thermally conductive elongate element positioned inside the catheter shaft, wherein the thermally conductive element is configured to be coupled to a distal tip of the catheter shaft; a button comprising a safety feature, wherein the button, when activated, initiates generation of vapor for ablation by the at least one thermally conductive element; a first control attached to the catheter shaft, the first control configured to perform at least one of advancement and retraction of the at least one thermally conductive element when actuated; and a second control attached to the catheter shaft and the at least one thermally conductive element configured to cause rotation of the thermally conductive element when actuated.

Alternatively, the angle is in the range of 0 degrees and 180 degrees.

The present specification also discloses a handle mechanism for a catheter device for ablating patient tissue, comprising: a first elongate portion; a second elongated portion pivotally connected to the first elongated portion and at a rotatable angle relative to the second portion; a catheter shaft extending through the handle mechanism and from a distal end of the second portion; at least one thermally conductive elongate element positioned inside the catheter shaft, wherein the thermally conductive element is configured to be coupled to a distal tip of the catheter shaft; a button comprising a safety feature, wherein the button, when activated, initiates generation of vapor for ablation by the at least one thermally conductive element; a first control attached to the catheter shaft, the first control configured to perform at least one of advancement and retraction of the at least one thermally conductive element when actuated; and a second controller attached to the catheter shaft and the at least one thermally conductive element configured to cause rotation of the thermally conductive element.

Alternatively, the angle is in the range of 0 to 180 degrees.

The present specification also discloses a steam ablation system for ablating prostate tissue of a patient, wherein the system comprises: at least one pump; a catheter having a length extending between a proximal end and a distal tip, wherein the catheter comprises: a connection port positioned on the proximal end of the catheter, wherein the catheter is in fluid communication with the at least one pump through the connection port; a first lumen in fluid communication with the connection port and configured to receive saline from the at least one pump via the connection port; at least one electrode positioned within the first lumen; and at least one thermally conductive elongate element having a lumen and configured to be coupled to the distal tip of the catheter such that a proximal end of the at least one thermally conductive elongate element is positioned at least 0.1mm and no more than 60mm from a distal-most electrode of the at least one electrode and such that the lumen of the at least one thermally conductive elongate element is in fluid communication with the first lumen; and a controller having at least one processor in data communication with the at least one pump, wherein, upon start-up, the controller is configured to: controlling delivery of saline into the first lumen; and controlling current delivery to the at least one electrode located within the first lumen.

Optionally, the at least one thermally conductive elongate element comprises a needle and a needle attachment component. The needle may have a tapered distal tip. The needle and the needle attachment member may be made of the same material, and the same material may be stainless steel. The proximal portion of the needle may be configured to pass over the distal end of the needle attachment member.

Optionally, the steam ablation system further comprises a needle chamber coupled to the distal tip of the catheter and configured to be retractable along a length of the catheter. The needle chamber may have an outer surface and a lumen defining an inner surface, wherein the outer surface comprises a first material, wherein the inner surface comprises a second material, and wherein the first material is different from the second material. The first material may be a polymer and the second material may be a metal. The needle chamber may have a lumen defining an inner surface, wherein the lumen is curved to receive a curved needle. The at least one thermally conductive elongate element may comprise a needle, wherein in a pre-deployment state the needle chamber is configured to be positioned over the needle, and wherein in a post-deployment state the needle chamber is configured to be retracted towards the proximal end of the catheter, and the needle is positioned outside the needle chamber. Optionally, the needle is further adapted to have a needle pre-chamber state, wherein in the needle pre-chamber state the needle has a first curvature, wherein in the pre-deployment state the needle has a second curvature, wherein in the post-deployment state the needle has a third curvature, wherein the first curvature is different from the second curvature and the third curvature, and wherein the second curvature is different from the third curvature. Optionally, the needle is further adapted to have a needle pre-chamber state, wherein in the needle pre-chamber state the needle has a first curvature, wherein in the pre-deployment state the needle has a second curvature, wherein in the post-deployment state the needle has a third curvature, wherein the first curvature is greater than both the second curvature and the third curvature, and wherein the third curvature is greater than the second curvature. Optionally, in the post-deployment state, the needle is configured to extend outwardly from the outer surface of the catheter at an angle between 30 ° and 90 °.

Optionally, the at least one thermally conductive elongate element comprises a needle and a needle attachment component, wherein the needle comprises an internal channel in fluid communication with the first lumen and a port allowing passage of steam from the internal channel to the external environment.

Optionally, the at least one thermally conductive elongate element comprises more than one needle.

Optionally, the at least one thermally conductive elongate element comprises a needle having a length extending from a proximal end to a tapered distal end, and further comprising an insulator located over the length of the needle. The insulator may be adapted to cover at least 5% of the length of the needle from the proximal end, wherein the insulator is adapted to not exceed 90% of the length of the needle from the proximal end.

Optionally, the controller is adapted to control delivery of saline into the first lumen and to control delivery of current to the at least one electrode such that greater than 0% and less than 75% of the continuous circumference of the patient's prostatic urethra is ablated.

Optionally, the controller is adapted to control the delivery of saline to the first lumen and to control the delivery of electrical current to the at least one electrode such that greater than 0% and less than 75% of the continuous circumference of the patient's ejaculatory duct is ablated.

Optionally, the controller is adapted to control the delivery of saline into the first lumen and the delivery of the current to the at least one electrode such that greater than 0% and less than 75% of the thickness of the rectal wall is ablated.

Optionally, the controller is adapted to control the delivery of saline to the first lumen and to control the delivery of electrical current to the at least one electrode such that greater than 0% and less than 75% of one of the continuous circumference of the ejaculatory duct and the central region of the prostate is ablated.

Optionally, the controller is adapted to control the delivery of saline into the first lumen and control the delivery of current to the at least one electrode such that a transition region of the prostate of the patient is ablated and greater than 0% and less than 75% of the anterior fibromuscular space of the patient is ablated.

The present specification also discloses a steam ablation system for treating a disease, wherein the system comprises: at least one pump; a catheter in fluid communication with the at least one pump through a catheter connection port, wherein a proximal end of the catheter is connected to the catheter connection port to place the catheter in fluid communication with the at least one pump, wherein the catheter comprises: at least one lumen for delivering saline delivered from the at least one pump; at least one electrode located within the at least one lumen; a plurality of openings near the distal end of the catheter; a plurality of thermally conductive elements extendable and retractable through the plurality of openings, wherein the plurality of thermally conductive elements are hollow, and wherein each of the plurality of thermally conductive elements includes a port that allows for delivery of steam; and a controller having at least one processor in data communication with the at least one pump, wherein, upon start-up, the controller is configured to: controlling delivery of saline into the at least one lumen in the catheter; controlling delivery of an electrical current to the at least one electrode located within the at least one lumen of the first catheter; and controlling the steam generated by the brine.

Optionally, the plurality of thermally conductive elements are pins.

Optionally, the plurality of thermally conductive elements extend from the conduit at an angle between 30 ° and 90 °.

Optionally, the system is for ablating prostate tissue of a patient through the patient's urethra, wherein greater than 0% and less than 75% of the continuous circumference of the patient's prostatic urethra is ablated.

Optionally, the system is for ablating prostate tissue of a patient through a urethra of the patient, wherein greater than 0% and less than 75% of a continuous circumference of the patient's ejaculatory duct is ablated.

Optionally, the system is for ablating prostate tissue of a patient through a rectal wall of the patient, wherein greater than 0% and less than 75% of the rectal wall thickness is ablated.

Optionally, the system is configured to ablate at least one of a central region or a transition region of the prostate while ablating greater than 0% and less than 75% of the continuous circumference of the prostatic urethra.

Optionally, the system is configured to ablate at least one of a central region or a transition region of the prostate while ablating greater than 0% and less than 75% of the continuous circumference of the ejaculatory duct.

Optionally, the system is configured to ablate the medial lobe of the prostate while ablating greater than 0% and less than 75% of one of the continuous circumference of the ejaculatory duct and the central region of the prostate.

Optionally, the system is configured to ablate a transition zone of the prostate while ablating greater than 0% and less than 75% of the Anterior Fibromuscular Space (AFS).

The present specification also discloses a method of ablating prostate tissue of a patient, comprising: providing an ablation system, the ablation system comprising: at least one pump; a catheter in fluid communication with the at least one pump, wherein a proximal end of the catheter is connected to the catheter connection port to place the catheter in fluid communication with the at least one pump, wherein the catheter comprises: at least one lumen configured to deliver saline delivered from the at least one pump; at least one electrode located within the at least one lumen; a plurality of openings near the distal end of the catheter; and a plurality of thermally conductive elements extendable and retractable through the plurality of openings, wherein the plurality of thermally conductive elements are hollow, and wherein each of the plurality of thermally conductive elements includes a port that allows for the delivery of steam; and a controller having at least one processor in data communication with the at least one pump, wherein, upon activation, the controller is configured to control delivery of saline into the at least one lumen in the catheter, wherein the electrode is configured to receive an electrical current and convert the saline into steam for ablation; inserting the catheter into the urethra of the patient; extending the thermally conductive element through the plurality of openings and into the prostate tissue; and programming the controller to control delivery of the vapor such that greater than 0% and less than 75% of the circumference of the prostate tissue or adjacent tissue is ablated.

Optionally, the thermally conductive element comprises a needle.

Optionally, the prostate tissue or adjacent tissue is the prostatic urethra.

Optionally, the prostate tissue or adjacent tissue is an ejaculatory duct.

Optionally, the prostate tissue or adjacent tissue is a rectal wall.

The present specification also discloses a steam ablation system for treating a disease, wherein the system comprises: at least one pump; a coaxial catheter for insertion into a patient's vagina toward a cervix, the coaxial catheter comprising: an outer catheter for advancement to an inner opening of a patient's cervix; an inner catheter for advancement into the uterus of the patient, the inner catheter being concentric and slidable within the outer catheter, wherein the inner catheter is in fluid communication with the at least one pump through a catheter connection port, wherein a proximal end of the inner catheter is connected to the catheter connection port to place the inner catheter in fluid communication with the at least one pump, wherein the inner catheter comprises: at least one lumen for delivering saline delivered from the at least one pump; at least one electrode located within the at least one lumen; at least two positioning elements separated along the length of the inner catheter, wherein a distal positioning element is advanced until a distal end of the distal positioning element contacts a bottom of a uterus, and a proximal positioning element is advanced to be positioned near an inner port of the patient and for forming a partial seal or contact with the inner port; and at least one opening proximate the distal positioning element of the inner catheter; a controller having at least one processor in data communication with the at least one pump, wherein, upon start-up, the controller is configured to: controlling delivery of saline into the at least one lumen in the coaxial catheter; controlling delivery of electrical current to the at least one electrode located within the at least one lumen of the inner catheter; and controlling the steam generated by the brine.

Optionally, the inner catheter is used to measure the length of the uterine cavity of the patient. Optionally, the measured length is used to determine the amount of steam used for ablation.

Alternatively, the partial seal is a temperature dependent seal and the partial seal breaks once the temperature within the sealed portion of the uterus exceeds 90 ℃.

Alternatively, the partial seal is a pressure-related seal and the partial seal breaks once the temperature within the sealed portion of the uterus exceeds 101 ℃ and the pressure exceeds 0.5 psi. Alternatively, the partial seal is a pressure related seal and breaks once the temperature within the sealed portion of the uterus exceeds 103 ℃ and the pressure exceeds 1.0 psi. Alternatively, the partial seal is a pressure related seal and breaks once the temperature within the sealed portion of the uterus exceeds 103 ℃ and the pressure exceeds 1.5 psi.

Optionally, the controller controls the steam to an amount that maintains at least one of an endometrial pressure below 50mm Hg and 10% above atmospheric pressure. Optionally, the controller controls the steam to an amount that maintains at least one of an endometrial pressure of less than 30mm Hg and 10% above atmospheric pressure. Optionally, the controller controls the steam to an amount that maintains at least one of an endometrial pressure below 15mm Hg and 10% above atmospheric pressure.

Optionally, at least one of the inner catheter and the outer catheter includes a ventilation element to allow ventilation of the uterus. Optionally, the venting element comprises a groove.

Optionally, the proximally located element includes at least one opening to allow uterine ventilation.

Optionally, the inner catheter includes a pressure sensor to allow the vapor pressure within the uterus to be maintained at less than 50mm Hg. Optionally, the inner catheter includes a pressure sensor to allow the vapor pressure within the uterus to be maintained at less than 30mm Hg. Optionally, the inner catheter includes a pressure sensor to allow the vapor pressure within the uterus to be maintained at less than 15mm Hg.

Optionally, each positioning element comprises an uncovered wire mesh.

The present specification also discloses a method of ablating prostate tissue of a patient, comprising: providing an ablation system, the ablation system comprising: at least one pump; a catheter in fluid communication with the at least one pump, wherein a proximal end of the catheter is connected to the catheter connection port to place the catheter in fluid communication with the at least one pump, wherein the catheter comprises: at least one lumen configured to deliver saline delivered from the at least one pump; at least one positioning element on a distal end of the at least one lumen; at least one electrode located within the at least one lumen; an outer sheath covering the at least one lumen; a plurality of openings on the outer sheath proximate the distal end of the catheter; and a plurality of thermally conductive elements extendable and retractable through the plurality of openings, wherein the plurality of thermally conductive elements are hollow, and wherein each of the plurality of thermally conductive elements includes a port that allows for the delivery of steam; and a controller having at least one processor in data communication with the at least one pump, wherein, upon activation, the controller is configured to control delivery of saline into the at least one lumen in the catheter, wherein the electrode is configured to receive an electrical current and convert the saline into steam for ablation; inserting a distal end of a catheter into a urethra of the patient; extending the distal end of the catheter into the bladder of the patient; retracting the outer sheath to expose the at least one lumen and the positioning element; expanding the positioning element; extending the thermally conductive element through the plurality of openings and into the prostate tissue; and programming the controller to control delivery of the vapor such that greater than 0% and less than 75% of the circumference of the prostate tissue or adjacent tissue is ablated.

Optionally, the thermally conductive element comprises a needle.

Optionally, the prostate tissue or adjacent tissue is the prostatic urethra.

Optionally, the prostate tissue or adjacent tissue is an ejaculatory duct.

Optionally, the prostate tissue or adjacent tissue is a rectal wall.

Optionally, expanding the positioning element includes positioning the positioning element near the bladder neck.

Optionally, expanding the positioning element includes positioning the positioning element within the prostatic urethra.

The present specification also discloses a method of ablating endometrial tissue in a patient, comprising: providing an ablation system, the ablation system comprising: at least one pump; a coaxial catheter for insertion into a patient's vagina toward a cervix, the coaxial catheter comprising: an outer catheter for advancement to an inner opening of a patient's cervix; an inner catheter for advancement into the uterus of the patient, the inner catheter being concentric and slidable within the outer catheter, wherein the inner catheter is in fluid communication with the at least one pump through a catheter connection port, wherein a proximal end of the inner catheter is connected to the catheter connection port to place the inner catheter in fluid communication with the at least one pump, wherein the inner catheter comprises: at least one lumen for delivering saline delivered from the at least one pump; at least one electrode located within the at least one lumen; at least two positioning elements separated along the length of the inner catheter, wherein a distal positioning element is advanced until a distal end of the distal positioning element contacts a bottom of a uterus, and a proximal positioning element is advanced to be positioned near an inner port of the patient and for forming a partial seal with the inner port; and a plurality of openings on the inner catheter and between the distal positioning element and the proximal positioning element for delivering steam; a controller having at least one processor in data communication with the at least one pump, wherein, upon activation, the controller is configured to control delivery of saline into the at least one lumen in the coaxial catheter and control steam generated by the saline; inserting the distal end of the catheter until the distal end of the distal positioning element contacts the bottom of the uterus and a proximal positioning element is advanced to be positioned near the patient's internal orifice; expanding the distal positioning element; expanding the proximally positioned element to form a partial seal within the inner port; and programming the controller to control delivery of the vapor for ablating endometrial tissue.

Optionally, the distal positioning element and the proximal positioning element each have a funnel shape.

Also disclosed herein is a method of ablating a prostate middle lobe in a patient with middle lobe hyperplasia, the method comprising: passing a catheter having at least one needle into the patient's spongy urethra and through the prostatic urethra such that the distal end of the catheter is positioned within the patient's bladder; extending the at least one needle from the distal end of the catheter and passing the needle through the bladder or bladder neck wall and into the medial leaflet; delivering an ablative agent through the at least one needle and into the middle lobe to ablate prostate tissue; and controlling the flow of the ablative agent using a controller to maintain the pressure in the bladder and middle lobe below 5 atm.

Optionally, the catheter further comprises at least one positioning element, and the method further comprises deploying the at least one positioning element to position the catheter in the bladder and stabilize the at least one needle prior to extending the at least one needle.

Also disclosed herein is a method of ablating the middle lobe of a prostate of a patient having middle lobe hyperplasia, the method comprising: providing an ablation system, the ablation system comprising: at least one pump; a catheter in fluid communication with the at least one pump, wherein a proximal end of the catheter is connected to the catheter connection port to place the catheter in fluid communication with the at least one pump, wherein the catheter comprises: at least one lumen configured to deliver saline delivered from the at least one pump; at least one electrode located within the at least one lumen; an outer sheath covering the at least one lumen; a plurality of openings on the outer sheath proximate the distal end of the catheter; and a plurality of thermally conductive elements extendable and retractable through the plurality of openings, wherein the plurality of thermally conductive elements are hollow, and wherein each of the plurality of thermally conductive elements includes a port that allows for the delivery of steam; and a controller having at least one processor in data communication with the at least one pump, wherein, upon activation, the controller is configured to control delivery of saline into the at least one lumen in the catheter, wherein the electrode is configured to receive an electrical current and convert the saline into steam for ablation; inserting the catheter into the patient's spongy urethra and through the prostatic urethra such that the distal end of the catheter is positioned within the patient's bladder; extending the plurality of thermally conductive elements from the distal end of the catheter through a bladder wall and into the medial leaflet; delivering an ablative agent through the plurality of thermally conductive elements and into the medial lobe to ablate prostate tissue; and programming the controller to control the flow of the ablative agent to maintain the pressure in the bladder and middle lobe below 5 atm.

Optionally, the catheter further comprises at least one positioning element, and the method further comprises deploying the at least one positioning element to position the catheter in the bladder and stabilize the plurality of thermally conductive elements prior to extending the plurality of thermally conductive elements.

The present specification also discloses a method for ablating at least one of a target area within or near a bladder of a patient, the method comprising: providing an ablation system, the ablation system comprising: at least one pump; a catheter in fluid communication with the at least one pump, wherein a proximal end of the catheter is connected to the catheter connection port to place the catheter in fluid communication with the at least one pump, wherein the catheter comprises: at least one lumen configured to deliver saline delivered from the at least one pump; at least one electrode located within the at least one lumen; a plurality of openings near the distal end of the catheter; and a plurality of thermally conductive elements extendable and retractable through the plurality of openings, wherein the plurality of thermally conductive elements are hollow, and wherein each of the plurality of thermally conductive elements includes a port that allows for the delivery of steam; and a controller having at least one processor in data communication with the at least one pump, wherein, upon activation, the controller is configured to control delivery of saline into the at least one lumen in the catheter, wherein the electrode is configured to receive an electrical current and convert the saline into steam for ablation; draining fluid from within the bladder from the vicinity of the target area; inserting the catheter into the ureter of the patient; extending the thermally conductive element through the plurality of openings and into or near the target area; and programming the controller to control delivery of the vapor to ablate the target area.

Optionally, the target region is at least one of a tissue, a tumor, or a nerve. Optionally, the target region is tissue within the bladder. Optionally, the target region is within the adventitial space below the patient's triangle. Optionally, the target area is within one of a bladder neck, an Internal Urethral Sphincter (IUS), and nerves supplying the IUS and bladder neck of the patient.

Optionally, draining the fluid includes draining urine from the bladder.

Optionally, draining the fluid further comprises performing at least one of: removing urine from the bladder; blowing air into the bladder; and positioning the patient such that the target area is positioned away from a slave portion of the bladder, thereby allowing urine to drain from the bladder.

Optionally, the thermally conductive element comprises a needle.

Optionally, the method further comprises applying a positioning element in the vicinity of the target area and surrounding at least a portion of the target area.

Optionally, the method further comprises maintaining the pressure within the bladder below 5atm.

The present specification also discloses a method for ablating at least one of a target area within or near a bladder of a patient, the method comprising: providing an ablation system, the ablation system comprising: at least one pump; a coaxial catheter for insertion into a ureter of a patient, the coaxial catheter comprising: an outer catheter for advancement to a ureter of a patient; an inner catheter for advancement into a ureter of a patient, the inner catheter being concentric and slidable within the outer catheter, wherein the inner catheter is in fluid communication with the at least one pump through a catheter connection port, wherein a proximal end of the inner catheter is connected to the catheter connection port to place the inner catheter in fluid communication with the at least one pump, wherein the inner catheter comprises: at least one lumen for delivering saline delivered from the at least one pump; at least one electrode located within the at least one lumen; at least one positioning element along the length of the inner catheter, wherein the at least one positioning element is advanced until a distal end of the positioning element encloses the target area; and at least one opening of the positioning element adjacent to the inner catheter; a controller having at least one processor in data communication with the at least one pump, wherein, upon start-up, the controller is configured to: controlling delivery of saline into the at least one lumen in the coaxial catheter; controlling delivery of electrical current to the at least one electrode located within the at least one lumen of the inner catheter; controlling steam generated by brine; draining fluid from within the bladder from the vicinity of the target area; inserting the coaxial catheter into the ureter of the patient; applying the positioning element in proximity to the target area surrounding at least a portion of the target area; and programming the controller to control delivery of the vapor to ablate the target area.

Optionally, the target region is at least one of a tissue, a tumor, or a nerve. Optionally, the target region is tissue within the bladder. Optionally, draining the fluid includes draining urine from the bladder.

Optionally, draining the fluid further comprises performing at least one of: removing urine from the bladder; blowing air into the bladder; positioning the patient such that the target area is positioned away from a slave portion of the bladder, thereby allowing urine to drain from the bladder.

The foregoing and other embodiments of the invention will be described more fully in the accompanying drawings and detailed description provided below.

Drawings

These and other features and advantages of the present invention will be further appreciated as they become better understood by reference to the detailed description when considered in conjunction with the accompanying drawings, wherein:

FIG. 1A illustrates an ablation system according to an embodiment of the present disclosure;

FIG. 1B is a cross-sectional view of a flexible heating chamber according to an embodiment of the present disclosure;

FIG. 1C illustrates transverse and longitudinal cross-sectional views of first and second electrode arrays of a flexible heating chamber according to embodiments of the present disclosure;

FIG. 1D is a cross-sectional view of the heating chamber of FIG. 1B, including assembled first and second electrode arrays, according to an embodiment of the present disclosure;

FIG. 1E is a longitudinal cross-sectional view of the heating chamber of FIG. 1B, including assembled first and second electrode arrays, according to an embodiment of the present disclosure;

FIG. 1F is a first longitudinal view of the two heating chambers of FIG. 1B arranged in series in a catheter tip according to an embodiment of the present disclosure;

FIG. 1G is a second longitudinal view of the two heating chambers of FIG. 1B arranged in series in the catheter tip according to an embodiment of the present disclosure;

FIG. 1H illustrates a multi-lumen balloon catheter containing one of the heating compartments of FIG. 1B according to an embodiment of the present disclosure;

FIG. 1I illustrates a multi-lumen balloon catheter including the two heating chambers of FIG. 1B according to an embodiment of the present disclosure;

FIG. 1J illustrates a catheter having proximal and distal positioning elements and an electrode heating chamber according to an embodiment of the present disclosure;

fig. 1K illustrates an ablation system for prostate tissue ablation according to an embodiment of the present disclosure;

FIG. 1L illustrates a catheter for prostate tissue ablation according to an embodiment of the present disclosure;

fig. 1M illustrates a system for prostate tissue ablation according to another embodiment of the present disclosure;

Fig. 1N shows an ablation system for endometrial tissue ablation according to an embodiment of the present disclosure;

FIG. 1O illustrates a catheter for endometrial tissue ablation according to an embodiment of the present disclosure;

FIG. 1P illustrates a system for endometrial tissue ablation according to another embodiment of the disclosure;

FIG. 1Q illustrates a controller for use with an ablation system according to an embodiment of the present disclosure;

fig. 1R illustrates a system for prostate tissue ablation according to another embodiment of the present disclosure;

fig. 1S illustrates a needle attachment component of a system for prostate tissue ablation according to some embodiments of the present description;

fig. 1T illustrates a needle chamber of a system for prostate tissue ablation according to some embodiments of the present description;

FIG. 1U illustrates another needle chamber of a system for tissue ablation according to some embodiments of the present disclosure;

FIG. 2A illustrates a single lumen dual balloon catheter including an in-line heating element according to an embodiment of the present disclosure;

FIG. 2B illustrates a coaxial lumen dual balloon catheter including an in-line heating element according to an embodiment of the present disclosure;

FIG. 3A shows a typical anatomy of a prostate region for descriptive purposes;

Fig. 3B shows an exemplary transparent view of the prostate anatomy highlighting peripheral regions in addition to other regions in the periphery of the prostate;

fig. 3C shows an oblique top transparent view of the prostate, showing various areas and the prostatic urethra;

FIG. 4A is a schematic view of a water cooled conduit according to another embodiment of the present disclosure;

FIG. 4B is a cross-sectional view of the end portion of the water cooled conduit of FIG. 4A;

FIG. 4C illustrates an embodiment of a distal end of a catheter for use with the system of FIG. 1M;

FIG. 4D illustrates other embodiments of a distal end of a catheter for use with the system of FIG. 1M;

FIG. 4E illustrates an embodiment of a slit vane for covering the opening of FIGS. 4C and 4D according to some embodiments of the present description;

fig. 4F shows an embodiment of a positioning element according to the present disclosure positioned at a distal end of an ablation catheter to position the ablation catheter in the prostatic urethra;

fig. 4G illustrates the distal end of an ablation catheter advanced through the prostatic urethra according to an exemplary embodiment of the present disclosure;

FIG. 4H illustrates the distal end of an ablation catheter advanced into the bladder according to an exemplary embodiment of the present disclosure;

FIG. 4I illustrates the distal end of an ablation catheter advanced further into the bladder in accordance with an exemplary embodiment of the present disclosure;

FIG. 4J illustrates a positioning element expanded at the distal end of an ablation catheter and retracted to position the positioning element near the bladder neck or urethra according to an exemplary embodiment of the present disclosure;

fig. 4K illustrates at least one needle extending from the distal end of the ablation catheter and into the prostate tissue according to an exemplary embodiment of the present disclosure;

fig. 4L illustrates delivery of an ablative agent through one or more needles and into prostate tissue, according to an exemplary embodiment of the present disclosure;

fig. 4M shows an ablation catheter advanced into the prostatic urethra and having a positioning element at a location proximal of the needle at the distal end of the catheter according to an alternative embodiment of the present disclosure;

fig. 4N shows a needle deployed into the prostate tissue at the distal end of an ablation catheter in accordance with an alternative embodiment of the present disclosure;

FIG. 4O is a flowchart showing steps involved in ablating a patient's prostate using an ablation catheter according to an embodiment of the present disclosure;

fig. 5A illustrates prostate ablation performed on a swollen prostate in a male urinary system by using a device according to an embodiment of the present disclosure;

fig. 5B is a schematic diagram of performing transurethral prostate ablation on a swollen prostate in a male urinary system using an ablation device in accordance with one embodiment of the subject specification;

Fig. 5C is a schematic illustration of performing transurethral prostate ablation on a swollen prostate in a male urinary system using an ablation device in accordance with another embodiment of the subject specification;

fig. 5D is a flowchart listing steps involved in transurethral enlargement of a prostate ablation procedure using an ablation catheter according to one embodiment of the present disclosure;

fig. 5E is a schematic diagram of performing transrectal prostate ablation on a swollen prostate in a male urinary system using an ablation device according to one embodiment of the present disclosure;

fig. 5F is a schematic illustration of performing transrectal prostate ablation on a swollen prostate in a male urinary system using a coaxial ablation device with a positioning element in accordance with another embodiment of the present disclosure;

FIG. 5G is a close-up illustration of the distal end of the catheter and the needle tip of the ablation device;

fig. 5H is a flowchart listing steps involved in a transrectal enlargement prostate ablation procedure using an ablation catheter according to one embodiment of the present disclosure;

FIG. 6A is a schematic diagram of an ablation catheter according to an embodiment of the present disclosure;

FIG. 6B is a cross-sectional view of the tip of the ablation catheter of FIG. 6A;

fig. 6C is a diagram of transurethral prostate ablation performed using the ablation catheter of fig. 6A, according to one embodiment;

Fig. 6D is a flowchart listing steps involved in a transurethral enlarged prostate ablation procedure, according to one embodiment;

FIG. 7A is a schematic view of an ablation catheter according to another embodiment of the disclosure;

FIG. 7B is a cross-sectional view of the tip of the ablation catheter of FIG. 7A;

fig. 7C is a diagram of transurethral prostate ablation performed using the ablation catheter of fig. 7A, according to one embodiment;

fig. 7D is a flowchart listing steps involved in a transurethral enlarged prostate ablation procedure, according to one embodiment.

FIG. 8A is a diagram of one embodiment of a positioning element of an ablation catheter depicting a plurality of thermally conductive elements attached thereto;

FIG. 8B is a diagram of one embodiment of a positioning element of an ablation catheter depicting a plurality of hollow thermally conductive elements attached thereto;

FIG. 9 is a flow chart illustrating one embodiment of a method of ablating tissue using a needle catheter device;

FIG. 10 is a flow chart illustrating a method of ablating submucosal tissue using a needle catheter device in accordance with one embodiment of the present disclosure;

FIG. 11A is an exemplary schematic illustration of a deformed needle according to one embodiment of the present disclosure;

FIG. 11B illustrates a different embodiment of a needle according to the present description;

FIG. 11C illustrates an exemplary process of delivering an ablative agent from a hollow opening at the edge of a pair of needles (e.g., the double needle of FIG. 11B), according to some embodiments of the present description;

FIG. 11D illustrates exemplary depths of needles of different curvatures according to some embodiments of the present description;

FIG. 11E illustrates an exemplary depth of a needle relative to the needle of FIG. 11D according to some embodiments of the present description;

FIG. 11F illustrates an exemplary length of the needle of FIG. 11E extending in a straight line from the port to the furthest distance reached by the needle body, in accordance with some embodiments of the present description;

FIG. 11G illustrates different views of a single needle assembly extending from a port according to some embodiments of the present description;

FIG. 11H illustrates one or more holes at a sharp edge of a needle in another horizontal view of the needle in accordance with some embodiments of the present description;

FIG. 11I illustrates a different view of a dual needle assembly extending from a port according to some embodiments of the present description;

FIG. 11J illustrates a different view of another dual needle assembly extending from a port according to some embodiments of the present disclosure;

FIG. 11K illustrates insulators on single and double pin configurations according to some embodiments of the present disclosure;

fig. 11L illustrates a single needle configuration with an insulator positioned within prostate tissue according to some embodiments of the present disclosure;

Fig. 11M illustrates a single needle configuration with an insulator, which is positioned within a uterine fibroid, according to some embodiments of the present disclosure;

fig. 11N illustrates a two-needle configuration in which two needles are inserted into separate prostate lobes according to some embodiments of the present description;

FIG. 11O illustrates an exemplary embodiment of a steerable catheter shaft, according to some embodiments of the present description;

FIG. 11P illustrates a needle having an open end according to some embodiments of the present description;

FIG. 11Q shows an alternative embodiment of a needle according to the present disclosure having a closed end and including a hole or opening along the uninsulated length of the needle;

fig. 12 is a schematic diagram of transurethral prostate ablation using an ablation device in accordance with an embodiment of the subject specification;

FIG. 13A is an illustration of one embodiment of a positioning element of an ablation catheter having a needle attached to a catheter body;

FIG. 13B is an illustration of another embodiment of a positioning element for an ablation catheter;

FIG. 13C shows a cross section of the distal tip of a catheter according to an embodiment of the present disclosure;

FIG. 14 illustrates one embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at variable insertion depths;

Fig. 15A is a flowchart showing a method of prostate tissue ablation according to one embodiment of the present disclosure;

fig. 15B is a flowchart showing a method of prostate tissue ablation according to another embodiment of the present disclosure;

fig. 15C shows a compression catheter with an expandable element advanced into the prostatic urethra according to embodiments of the present disclosure;

fig. 15D shows an expanded expandable element of a catheter according to an embodiment of the present disclosure pressed against the urethral wall that presses against the prostate and the ablative agent is delivered from inside the expandable member and into the prostate tissue;

fig. 15E shows a widened prostatic urethra after removal of the expandable catheter in accordance with embodiments of the present disclosure;

FIG. 15F illustrates an exemplary use of an expanded expandable element and one or more needles of a catheter to allow delivery of an ablative agent, such as steam or vapor (vapor), through a hollow outlet at the edge of the needle, according to some embodiments of the present description;

FIG. 15G illustrates an ablation catheter for ablating prostate tissue of a patient with middle lobe hyperplasia by a transcapsular approach according to one embodiment of the present disclosure;

FIG. 15H illustrates an ablation catheter for ablating prostate tissue of a patient with middle lobe hyperplasia by a transcapsular approach according to another embodiment of the present disclosure;

FIG. 15I is a flowchart outlining steps in one method of ablating tissue of a prostate of a patient with middle lobe hyperplasia by transcapsular approach using an ablation catheter in accordance with one embodiment of the present disclosure;

FIG. 16A is an International Prostate Symptom Score (IPSS) questionnaire;

fig. 16B is a Benign Prostatic Hyperplasia Impact Index Questionnaire (BPHIIQ);

FIG. 17A shows a typical anatomy of the uterus and fallopian tubes of a human female;

FIG. 17B shows the location of the uterus and surrounding anatomy within a female body;

fig. 18A illustrates an exemplary ablation catheter arrangement for ablating a uterus according to some embodiments of the present description;

FIG. 18B illustrates an exemplary embodiment of a groove configured in the inner catheter of FIG. 18A according to some embodiments of the present description;

fig. 18C is a flowchart of a method of ablating endometrial tissue using the catheter of fig. 18A, according to an embodiment of the disclosure;

fig. 18D illustrates a catheter for endometrial ablation according to other embodiments of the disclosure;

fig. 18E shows a catheter with an expanded distal positioning element advanced through the cervical canal and into the uterus according to an embodiment of the present disclosure;

FIG. 18F illustrates a catheter with an expanded distal positioning element and an expanded proximal positioning element advanced further into the uterus according to embodiments of the present disclosure;

FIG. 18G illustrates steam delivered into the uterus through a plurality of ports on the catheter body and positioned between the proximal and distal positioning elements according to embodiments of the present disclosure;

fig. 18H is a flowchart showing steps involved in ablating endometrium of a patient using an ablation catheter according to embodiments of the present disclosure;

fig. 18I illustrates a side view, a cross-sectional side view, and a distal front view of an endometrial ablation catheter in accordance with some embodiments of the specification;

FIG. 18J illustrates a perspective side view of the catheter of FIG. 18I with a stent extending over the inner catheter and from the outer catheter, according to some embodiments of the present disclosure;

fig. 18K illustrates a cross-sectional side view, a perspective side view, and a distal front view of a braided stent in accordance with some embodiments of the present description;

FIG. 18L illustrates a side perspective view of the distal end of an inner catheter according to some embodiments of the present disclosure;

FIG. 18M illustrates a side front perspective view of the distal end of an inner catheter according to some embodiments of the present disclosure;

FIG. 18N illustrates a top perspective view of the distal end of an inner catheter according to some embodiments of the present disclosure;

FIG. 18O illustrates a different view of a dual positioning element catheter with atraumatic olive tip in accordance with another embodiment of the present specification;

Fig. 18P illustrates a distal end of an ablation catheter having a distally located element and a plurality of ports along the length of the catheter shaft, in accordance with some embodiments of the present disclosure;

fig. 18Q illustrates a distal end of an ablation catheter having a distal olive tip, a positioning element, and a plurality of ports along the length of the catheter shaft, in accordance with some embodiments of the present disclosure;

fig. 18R illustrates a side view of a distal end of an ablation catheter having a distal olive tip, two positioning elements, and a plurality of ports along the length of the catheter shaft, in accordance with some embodiments of the present disclosure;

FIG. 18S shows a rear perspective view of the catheter of FIG. 18R;

fig. 18T illustrates a distal end of an ablation catheter having a semicircular opening at the distal end and a distal positioning element according to some embodiments of the present disclosure;

fig. 18U illustrates a distal end of an ablation catheter having a spherical distal positioning element and a cover extending over all or a portion of the positioning element, according to an exemplary embodiment of the present disclosure;

fig. 18V illustrates a distal end of an ablation catheter having a spherical distal positioning element according to another exemplary embodiment of the present disclosure;

fig. 18W illustrates a distal end of an ablation catheter with a conical distal positioning element according to yet another exemplary embodiment of the present disclosure;

FIG. 18X illustrates an atraumatic soft tip of a catheter shaft for insertion into a cervix, in accordance with some embodiments of the present disclosure;

FIG. 19A illustrates a configuration of a disc for use with the catheter device of FIG. 18A according to one embodiment of the present disclosure;

FIG. 19B illustrates a configuration of a disk for use with the catheter device of FIG. 18A in accordance with another embodiment of the present disclosure;

FIG. 19C illustrates various configurations of a disc for use with the catheter device of FIG. 18A in accordance with other embodiments of the present description;

FIG. 19D illustrates a catheter and handle and collar assembly according to some embodiments of the present disclosure;

FIG. 19E illustrates a position when the collar is positioned at the external orifice outside of the uterus and cervix prior to deployment of the catheter in accordance with some embodiments of the present specification;

FIG. 19F illustrates an exemplary position of a hand holding a catheter to deploy a proximal positioning element, in accordance with some embodiments of the present disclosure;

FIG. 19G illustrates expansion of the proximally located element when a user pushes on the handle of the catheter to extend the inner catheter within the uterus, in accordance with some embodiments of the present disclosure;

FIG. 19H illustrates deployment of a distally located element, which may be uncoated or optionally coated with silicone, according to some embodiments of the present disclosure;

FIG. 19I illustrates a rotary dial to further retract the first positioning element to partially seal the cervical opening, isolating the uterus, according to some embodiments of the present description;

fig. 19J illustrates a distal end of an ablation catheter having two positioning elements and a plurality of ports along the length of the catheter shaft, in accordance with some embodiments of the present disclosure;

fig. 19K illustrates a distal end of an ablation catheter having two positioning elements, a distal olive tip, and a plurality of ports along the length of the catheter shaft, according to some embodiments of the present disclosure;

fig. 19L illustrates a connector for connecting a distal positioning element to a distal end of an ablation catheter in accordance with some embodiments of the present disclosure;

fig. 19M illustrates another connector for connecting a distally located element to the distal end of an ablation catheter in accordance with other embodiments of the present disclosure;

fig. 19N illustrates a connector for connecting a proximally located element to a distal end of an ablation catheter in accordance with some embodiments of the present disclosure;

FIG. 19O illustrates another connector for connecting a proximally located element to the distal end of an ablation catheter in accordance with other embodiments of the present disclosure;

FIG. 19P illustrates a shaft of an ablation catheter depicting a plurality of ports according to some embodiments of the present disclosure;

FIG. 20A illustrates endometrial ablation in a female uterus by use of an ablation device in accordance with an embodiment of the present disclosure;

fig. 20B is a schematic view of a coaxial catheter for endometrial tissue ablation according to an embodiment of the disclosure;

fig. 20C is a flowchart listing steps involved in an endometrial tissue ablation procedure using a coaxial ablation catheter, according to an embodiment of the disclosure;

FIG. 20D is a schematic view of a bifurcated coaxial catheter for endometrial tissue ablation in accordance with one embodiment of the present disclosure;

FIG. 20E is a flowchart outlining the steps of a method for ablating endometrial tissue using the ablation catheter of FIG. 20D in accordance with one embodiment of the present specification;

FIG. 20F is a schematic view of a bifurcated coaxial catheter with expandable elements for use in endometrial tissue ablation in accordance with one embodiment of the present disclosure;

FIG. 20G is an illustration of the catheter of FIG. 20F inserted into a patient's uterine cavity for endometrial tissue ablation;

FIG. 20H is a flowchart outlining the steps of a method of ablating endometrial tissue using the ablation catheter of FIG. 20F in accordance with one embodiment of the present disclosure;

FIG. 20I is a schematic view of a bifurcated coaxial catheter for endometrial tissue ablation in accordance with another embodiment of the present disclosure;

FIG. 20J is a schematic view of a bifurcated coaxial catheter for endometrial tissue ablation in accordance with a further embodiment of the present disclosure;

FIG. 20K is a schematic view of a water cooled catheter for use in endometrial tissue ablation according to an embodiment of the disclosure;

FIG. 20L is a schematic view of a water cooled catheter for endometrial tissue ablation and positioned in a patient's uterus according to another embodiment of the disclosure;

fig. 20M is a schematic view of a water-cooled catheter for cervical ablation according to one embodiment of the present disclosure;

FIG. 20N is an illustration of the catheter of FIG. 20M positioned in a patient's cervix;

fig. 20O is a flowchart listing steps involved in performing cervical ablation using the catheter of fig. 20M;

fig. 21A is a flowchart showing a method of endometrial tissue ablation according to an embodiment of the disclosure;

fig. 21B is a flowchart showing a method of ablating uterine fibroids in accordance with one embodiment of the present disclosure;

fig. 21C illustrates an exemplary configuration of a distal end of a catheter for endometrial ablation in accordance with some embodiments of the present disclosure;

fig. 21D illustrates a distal end of a catheter for endometrial ablation with a positioning element attached thereto, according to some embodiments of the present disclosure;

FIG. 21E illustrates a deployed configuration and a compressed configuration of a distal end of a catheter for endometrial ablation according to some embodiments of the specification;

fig. 21F illustrates an embodiment of a catheter for endometrial ablation according to some embodiments of the present disclosure, wherein the positioning element is in its deployed configuration;

FIG. 21G illustrates a different three-dimensional view of the locating element and connector of FIG. 21F in its deployed configuration according to some embodiments of the present description;

FIG. 21H illustrates a different view of another embodiment of a positioning element in its deployed configuration according to some embodiments of the present disclosure;

FIG. 21I illustrates coaxial telescoping movement of an inner catheter within an outer sheath when a positioning element is deployed to a fully expanded configuration and compressed, according to some embodiments of the present disclosure;

fig. 21J illustrates a system for endometrial tissue ablation according to some embodiments of the present disclosure;

FIG. 21K is a flowchart showing steps involved in ablating endometrium of a patient using an ablation catheter according to embodiments of the present disclosure;

FIG. 22A shows different stages of bladder cancer as known in the medical arts;

FIG. 22B illustrates a system for ablating bladder tissue according to an embodiment of the present disclosure;

FIG. 23 illustrates an exemplary catheter for insertion into a bladder to ablate bladder tissue in accordance with some embodiments of the present description;

FIG. 24A illustrates a front end view of a positioning element according to some embodiments of the present description;

FIG. 24B illustrates a side view of the distal end of the ablation catheter and positioning element of FIG. 24A;

FIG. 24C illustrates a front perspective view of the distal end of the ablation catheter and positioning element of FIG. 24B;

fig. 25A illustrates a close-up view of a connection between a positioning element and a distal end of an ablation catheter in accordance with some embodiments of the present disclosure;

FIG. 25B shows a side view of a positioning element attached to the distal end of the ablation catheter of FIG. 25A;

FIG. 25C illustrates different types of configurations of positioning elements that may be used with various ablation catheters according to embodiments of the present disclosure;

FIG. 26A illustrates the positioning of a needle ablation catheter for delivering steam to selectively ablate the deep detrusor and the rich nerve layer of the adventitial space below the triangle, in accordance with an embodiment of the present disclosure;

FIG. 26B illustrates the positioning of a needle ablation device for delivering steam to selectively ablate the bladder neck, internal Urethral Sphincter (IUS), and nerves supplying the IUS and bladder neck in accordance with an embodiment of the present disclosure;

FIG. 27A illustrates a different view of a coaxial needle that may be used for ablation to treat OAB in accordance with some embodiments of the present disclosure;

FIG. 27B illustrates a distal end of a coaxial needle including an inner tube and an outer tube having a lumen according to some embodiments of the present disclosure;

FIG. 28 is a flowchart illustrating an exemplary process of ablating a bladder and/or its peripheral area according to some embodiments of the present description;

fig. 29 illustrates a system for prostate tissue ablation and imaging in accordance with an embodiment of the present disclosure;

fig. 30 illustrates a system for endometrial tissue ablation and imaging in accordance with an embodiment of the present disclosure;

FIG. 31 illustrates a system for bladder tissue ablation and imaging according to an embodiment of the present disclosure;

FIG. 32 illustrates various components of an optical/viewing system for direct visualization of ablation according to an embodiment of the present disclosure;

FIG. 33 illustrates components of the distal end of an ablation system useful for treating Benign Prostatic Hyperplasia (BPH) and Abnormal Uterine Bleeding (AUB) used in accordance with embodiments of the present disclosure;

FIG. 34 illustrates an image of a distal end of an ablation catheter viewed on a display device in accordance with some embodiments of the present disclosure;

FIG. 35A depicts a cross-sectional view of an embodiment of a combination catheter including a lumen for an optical/electrical catheter and a lumen for an ablation catheter, according to some embodiments of the present disclosure;

FIG. 35B depicts a cross-sectional view of another embodiment of a combination catheter including a lumen for an optical/electrical catheter and a lumen for an ablation catheter, according to some embodiments of the present disclosure;

FIG. 35C depicts a cross-sectional view of yet another embodiment of a combination catheter including a lumen for an optical/electrical catheter and a lumen for an ablation catheter in accordance with some embodiments of the present disclosure;

FIG. 36A illustrates an embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at variable insertion depths;

FIG. 36B illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 36C illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 36D illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 36E illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 36F illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 36G illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 36H illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 36I illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 36J illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 37A illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 37B illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 37C illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 37D illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 37E illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 37F illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 38 illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at variable insertion depths;

FIG. 39A illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 39B illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 39C illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 39D illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 40A illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 40B illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 41 illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

FIG. 42 illustrates another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at variable insertion depths;

FIG. 43 illustrates yet another embodiment of a handle mechanism that may be used to deploy and retract an ablation needle at a variable insertion depth;

fig. 44A illustrates an embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44B illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44C illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44D illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44E illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44F illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44G illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44H illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

Fig. 44I illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

FIG. 44J shows a reproduction view of the embodiment of the handle of FIG. 44I for use with the endometrial ablation system of the specification;

fig. 44K illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44L illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

FIG. 44M shows a reproduction view of the embodiment of the handle of FIG. 44L for use with the endometrial ablation system of the specification;

fig. 44N illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44O illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44P illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

fig. 44Q illustrates another embodiment of a handle for use with the endometrial ablation system of the specification;

FIG. 44R shows a reproduction view of the embodiment of the handle of FIG. 44Q for use with the endometrial ablation system of the specification;

Fig. 45 illustrates an ablation system using at least one microwave antenna to convert a liquid to a vapor in a heating chamber in accordance with an embodiment of the present disclosure;

FIG. 46 illustrates a multi-lumen balloon catheter containing one of the heating compartments of FIG. 45, according to an embodiment of the present disclosure;

FIG. 47 illustrates the multi-lumen balloon catheter of FIG. 45 including two heating chambers according to an embodiment of the present disclosure;

FIG. 48 illustrates a catheter having proximal and distal positioning elements and a microwave heating chamber according to an embodiment of the present disclosure;

fig. 49 shows an ablation system with a microwave heating chamber for ablating prostate tissue in accordance with an embodiment of the present disclosure;

fig. 50 shows a catheter with a microwave heating compartment for prostate tissue ablation according to an embodiment of the present disclosure;

fig. 51 illustrates a system having a microwave chamber for ablating prostate tissue according to another embodiment of the present disclosure;

fig. 52 illustrates a system having a microwave chamber for ablating prostate tissue in accordance with another embodiment of the present disclosure;

fig. 53 illustrates an ablation system having a microwave heating chamber for ablating endometrial tissue in accordance with an embodiment of the present disclosure;

FIG. 54 illustrates a catheter with a microwave heating chamber for ablating endometrial tissue in accordance with an embodiment of the present disclosure;

Fig. 55 illustrates a system for ablating endometrial tissue with a microwave heating chamber according to another embodiment of the disclosure; and

fig. 56 illustrates a system having a microwave heating chamber for ablating bladder tissue, according to an embodiment of the present disclosure.

Detailed Description

In various embodiments, the ablation devices and catheters described in this specification are used in combination with any one or more of the heating systems described in U.S. patent application Ser. No. 14/594,444 entitled "Method and Apparatus for Tissue Ablation (method and apparatus for tissue ablation)" filed on 1 month 12 2015 and issued on 2 month 7 of 2017, U.S. patent No. 9,561,068, the entire contents of which are incorporated herein by reference. U.S. patent application Ser. No. 15/600,670, entitled "Ablation Catheter with Integrated Cooling," filed 5/19/2017; 15/144,768 entitled "instruction-Based Micro-Volume Heating System" filed 5/2/2016 and issued as U.S. Pat. No. 10,064,697 at 4/9/2018; U.S. patent No.14/158,687 entitled "Method and Apparatus for Tissue Ablation (method and apparatus for tissue ablation)" filed on 1 month 17 of 2014 and published on 7 month 2 of 2017 as U.S. patent No. 9,561,067; 13/486,980 entitled "Method and Apparatus for Tissue Ablation" filed on 1/6/2012 and published on 7/2/2017 as U.S. patent No. 9,561,066; and U.S. patent application Ser. No. 12/573,939, entitled "Method and Apparatus for Tissue Ablation (method and apparatus for tissue ablation)" filed on 10/6/2009, the entire contents of which are incorporated herein by reference.

"treatment" and variations thereof refer to any reduction in the degree, frequency or severity of one or more symptoms or signs associated with a disorder.

"duration" and variants thereof refer to the time course of prescribed treatment from beginning to end, whether the treatment is ended due to resolution of the condition or the treatment is suspended for any reason. During treatment, a plurality of treatment periods may be prescribed during which one or more prescribed stimuli are administered to the subject.

"period" refers to the time that a "dose" of stimulation is administered to a subject as part of a prescribed treatment plan.

The term "and/or" means one or all of the listed elements or a combination of any two or more of the listed elements.

In the description and claims of the present application, each of the words "comprising," "including," and "having," and forms thereof, is not necessarily limited to members of the list that may be associated with the word. The term "comprising" and its variants are not intended to have a limiting meaning when these terms are present in the description and in the claims.

Unless otherwise indicated, "a," "an," "the," "one or more," and "at least one" are used interchangeably and mean one or more than one.

The term "controller" refers to an integrated hardware and software system defined by a plurality of processing elements (such as integrated circuits, application specific integrated circuits, and/or field programmable gate arrays) in data communication with a memory element (such as random access memory or read only memory), wherein one or more of the processing elements are configured to execute program instructions stored in the one or more memory elements.

The term "steam generation system (vapor generation system)" refers to any or all of the heater-based or induction-based methods of generating steam from water described in this application.

Embodiments of the present description may be used to treat genitourinary structures, wherein the term "genitourinary" includes all genitourinary and urinary structures including, but not limited to, the prostate, uterus and bladder, and any condition associated therewith, including, but not limited to, benign Prostatic Hyperplasia (BPH), prostate cancer, uterine fibroids, abnormal Uterine Bleeding (AUB), overactive bladder (OAB), stenosis and tumors.

Any and all needles and needle configurations disclosed in this specification with respect to particular embodiments, including, for example, but not limited to, single needle, double needle, multiple needle, and insulated needle, are not exclusive of this embodiment, and may be used in any organ system with any other embodiment disclosed in this specification for any condition associated with the organ system, such as, but not limited to, ablation of the prostate, uterus, and bladder.

For purposes of this specification, "complete ablation" is defined as ablating more than 55% of the surface area or volume surrounding the anatomy.

All methods and systems for treating the prostate, uterus and bladder may include optics or visualization as described in the specification to aid in direct visualization during ablation procedures.

In some embodiments, all of the ablation catheters disclosed in this specification include an insulator at the location of the electrode(s) to prevent tissue near the electrode location within the ablation catheter.

For any of the methods disclosed herein including discrete steps, the steps may be performed in any order possible. Also, any combination of two or more steps may be performed simultaneously, as the case may be.

Further, herein, recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.). Unless otherwise indicated, all numbers expressing quantities of ingredients, molecular weights, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about". Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and claims are approximations that may vary depending upon the desired properties sought to be obtained by the present specification. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the specification are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. However, all numerical values inherently contain certain ranges necessarily resulting from the standard deviation found in their respective testing measurements.

The devices and methods of the present disclosure can be used to cause controlled focal or circumferential ablation of target tissue to different depths in a manner that full healing with re-epithelialization can occur. In addition, steam can be used to treat/ablate benign and malignant tissue growth, resulting in destruction, liquefaction and absorption of ablated tissue. The dosage and manner of treatment can be adjusted based on the type of tissue and the desired depth of ablation. The ablation device may be used for prostate and endometrial ablation and for the treatment of any mucosal, submucosal or circumferential lesions, such as inflammatory lesions, tumors, polyps and vascular lesions. The ablation device may also be used for bladder ablation, and for treating overactive bladder (OAB). The ablation device may also be used to treat focal or circumferential mucosal or submucosal lesions of the genitourinary tract. The ablation device may be placed endoscopically, radiologically, surgically, or under direct visualization. In various embodiments, a wireless endoscope or a single fiber endoscope may be incorporated as part of the device. In another embodiment, magnetic or stereotactic navigation may be used to navigate the catheter to a desired location. A radio-opaque or acoustically transparent material may be incorporated into the body of the catheter for radiolocation. Ferromagnetic materials may be incorporated into the catheter to aid in magnetic navigation.

Ablative agents such as steam, heated gas, or cryogen (such as but not limited to liquid nitrogen) are inexpensive and readily available and are directed onto tissue via an injection port, held at a fixed and consistent distance, for targeting ablation. This allows for a uniform distribution of the ablative agent over the target tissue. The flow of the ablative agent is controlled by the microprocessor according to a predetermined method based on the characteristics of the tissue to be ablated, the desired depth of ablation, and the distance of the port from the tissue. The microprocessor may use temperature, pressure, or other sensed data to control the flow of the ablative agent. In addition, one or more aspiration ports are provided to aspirate ablative agents from the vicinity of the target tissue. The target segment may be treated by continuous infusion of the ablative agent or by infusion and removal cycles of the ablative agent as determined and controlled by a microprocessor.

It should be understood that the apparatus and embodiments described herein are implemented with a controller that includes a microprocessor that executes control instructions. The controller may be in the form of any computing device, including desktop, laptop, and mobile devices, and may communicate control signals to the ablation device in wired or wireless form.

The present invention relates to a plurality of embodiments. The following disclosure is provided to enable any person of ordinary skill in the art to practice the invention. No language used in the specification should be construed as indicating any non-claimed embodiment as essential to any possible embodiment or as limiting the scope of the claims over the use of such terms. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing the exemplary embodiments and should not be regarded as limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For the sake of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the invention.

It should be noted herein that any feature or component described in association with a particular embodiment may be used and implemented with any other embodiment unless explicitly stated otherwise.

Fig. 1A illustrates an ablation system 100 according to an embodiment of the present disclosure. The ablation system comprises a catheter 10, the catheter 10 having at least one first distal attachment or positioning element 11 and an internal heating chamber 18, the internal heating chamber 18 being disposed within the lumen of the catheter 10 and configured to heat a fluid provided to the catheter 10 to change the fluid to steam for ablation therapy. The internal heating chamber 18 includes an electrode or array of electrodes separated from the thermally conductive element by a non-conductive section of the catheter 10. In some embodiments, the catheter 10 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. Catheter 10 includes one or more infusion ports 12 for infusing an ablative agent (e.g., vapor). In some embodiments, the one or more infusion ports 12 comprise a single infusion port at the distal end of the needle. In some embodiments, the catheter includes a second positioning element 13 proximal to the infusion port 12. In various embodiments, the first distal attachment or positioning element 11 and the second positioning element 13 may be any of a disc, a cap, or an inflatable balloon. In some embodiments, the distal attachment or positioning element has a wire mesh structure with or without a cover film. In some embodiments, the first distal attachment or positioning element 11 and the second positioning element 13 include holes 19 for air or ablative agent to escape. A fluid, such as saline, is stored in a reservoir (such as saline pump 14) connected to the catheter 10. The delivery of the ablative agent is controlled by the controller 15 and the treatment is controlled by the treating physician via the controller 15. The controller 15 includes at least one processor 23 in data communication with the brine pump 14 and a conduit connection port 21 in fluid communication with the brine pump 14. In some embodiments, at least one optional sensor 17 monitors changes in the ablation zone to direct the flow of the ablative agent. In some embodiments, optional sensor 17 comprises at least one of a temperature sensor or a pressure sensor. In some embodiments, the conduit 10 includes a filter 16 having micro-pores that provide back pressure to the vapor being delivered, thereby pressurizing the vapor. The predetermined size of the pores in the filter determines the back pressure and thus the temperature of the vapor being produced. In some embodiments, the system further comprises a foot pedal 25 in data communication with the controller 15, a switch 27 on the conduit 10, or a switch 29 on the controller 15 for controlling the steam flow. In various embodiments, the switch 29 is positioned on the generator or catheter handle.

In one embodiment, a user interface included in the controller 15 allows the physician to define the device, organ, and condition, which in turn creates default settings for temperature, circulation, volume (sound), and standard RF settings. In one embodiment, these default values may be further modified by the physician. The user interface also includes a standard display of all key variables, as well as warnings if the value exceeds or falls below a certain level.

The ablation device also includes a safety mechanism to prevent the user from being burned, including insulation, and optionally cold air flushing, cold water flushing, and alarms/tones, when the catheter is maneuvered to indicate the start and stop of treatment.

Fig. 1B is a cross-sectional view 121 of a flexible heating compartment 130 according to an embodiment of the present disclosure, the flexible heating compartment 130 configured to be incorporated at or into a distal portion or tip of a catheter. Fig. 1C shows a transverse cross-sectional view 122a and a longitudinal cross-sectional view 122b of a first electrode array 136 and a transverse cross-sectional view 123a and a longitudinal cross-sectional view 123b of a second electrode array 138 of a flexible heating chamber for a catheter in accordance with embodiments of the present disclosure. Fig. 1D and 1E are a transverse cross-sectional view 124 and a longitudinal cross-sectional view 125, respectively, of a heating chamber 130 including assembled first and second electrodes 136, 138.

Referring now to fig. 1B, 1C, 1D, and 1E simultaneously, the heating compartment 130 includes an outer cover 132 and a coaxial inner core, channel, or lumen 134. A plurality of electrodes configured as a first electrode array 136 and a second electrode array 138 are disposed between the outer cover 132 and the lumen 134. In some embodiments, the first electrode array 136 and the second electrode array 138 include metal rings 142, 144, respectively, and a plurality of electrode fins or members 136', 138' extend radially from the metal rings 142, 144 into the space between the outer cover 132 and the insulating core/lumen 134 (see 122a, 123 a). The electrode fins or elements 136', 138' also extend longitudinally along the longitudinal axis 150 of the heating chamber 130 (see 122b, 123 b). In other words, each of the electrode fins 136', 138' has a first dimension along the radius of the heating chamber 130 and a second dimension along the longitudinal axis 150 of the heating chamber 130. The electrode fins or elements 136', 138' define a plurality of segmented spaces 140 therebetween, with the brine/water flowing through the segmented spaces 140 and evaporating to a vapor. Current is directed from the controller into the catheter, through the lumen, and to the electrodes 136, 138, which causes the fins or elements 136', 138' to generate an electrical charge that is then conducted through the saline to heat the saline and convert the saline to steam. The first and second dimensions enable the electrodes 136, 138 to have an increased surface area for heating the brine/water flowing in the space 140. According to an embodiment, the first electrode 136 has a first polarity and the second electrode 138 has a second polarity opposite to the first polarity. In one embodiment, the first polarity is negative (cathode) and the second polarity is positive (anode).

In an embodiment, the outer covering 132 and the inner core/lumen 134 are constructed of silicone, teflon, ceramic, or any other suitable thermoplastic/electrically insulating elastomer known to those of ordinary skill in the art. The inner core/lumen 134, outer cover 132, electrodes 136, 138 (including rings 142, 144 and fins or elements 136', 138') are all flexible to allow the distal portion or tip of the catheter to bend, thereby providing better positioning of the catheter during an ablation procedure. In an embodiment, the inner core/lumen 134 stabilizes the electrodes 136, 138 and maintains a separation or spacing 140 between the electrodes 136, 138 while the tip of the catheter flexes or bends during use, preventing the electrodes from physically contacting each other and shorting.

As shown in fig. 1D and 1E, when the heating chamber 130 is assembled, the electrode fins or elements 136', 138' cross or interlock with each other (similar to the fingers of two gripping hands) such that the cathode element is followed by the anode element, which is followed by the cathode element, which is again followed by the anode element, and so on, wherein the space 140 separates each cathode and anode element. In various embodiments, each space 140 has a distance ranging from 0.01mm to 2mm from the cathode element to the anode element. In some embodiments, the first electrode array 136 has a range of 1 to 50 electrode fins 136', preferably a number of 4 electrode fins 136', while the second electrode array 138 has a range of 1 to 50 electrode fins 138', preferably a number of 4 electrode fins 138'. In various embodiments, the heating chamber 130 has a width w in the range of 1 to 5mm and a length l in the range of 5 to 500 mm.

According to one aspect of the present disclosure, a plurality of heating chambers 130 may be disposed in the catheter tip. Fig. 1F and 1G are longitudinal cross-sectional views of a catheter tip 155 according to embodiments of the present disclosure, wherein two heating chambers 130 are arranged in series. Referring to fig. 1F and 1G, two heating compartments 130 are arranged in series such that a space 160 between the two heating compartments 130 acts as a hinge to impart increased flexibility to the conduit end 155 to allow it to flex. The two heating chambers 130 include first and second electrode arrays 136, 138, respectively, that intersect one another. The use of multiple (e.g., two or more) heating chambers 130 enables further increases in the surface area of the electrodes 136, 138 while maintaining the flexibility of the catheter tip 155.

Referring now to fig. 1B-1G, to generate vapor, fluid is delivered from a reservoir (e.g., a syringe) to the heating chamber 130 by a pump or any other pressurizing device. In embodiments, the fluid is sterile saline or water delivered at a constant or variable fluid flow rate. An RF generator connected to the heating chamber 130 provides power to the first and second electrode arrays 136, 138. As shown in fig. 1E, during steam generation, as fluid flows through the space 140 in the heating chamber 130 and power is applied to the electrodes 136, 138, the electrodes are charged, which heats the brine by brine conduction, electrical resistance, and evaporates the water in the brine. In other embodiments, conductive heating, convective heating, microwave heating, or inductive heating is used to convert brine to steam. The fluid is heated in the first proximal region 170 of the heating compartment 130. When the fluid is heated to a sufficient temperature, for example 100 degrees celsius at atmospheric pressure, the fluid begins to convert to steam or vapor in the second intermediate region 175. All of the fluid turns into steam when it reaches the third distal region 180, after which it may exit the distal end 133 of the heating compartment 130 and exit the catheter tip 155. If the pressure in the heating chamber is greater than atmospheric, a higher temperature will be required and if it is below atmospheric, a lower temperature will produce steam. When no brine flows through the chamber, the current through the chamber will be interrupted (dry electrode) and no heat will be generated. The measurement of electrode impedance can be used to measure the flow of saline and dry and wet electrodes.

In one embodiment, the sensor probe may be positioned at the distal end of a heating chamber within the catheter. During steam generation, the sensor probe transmits a signal to the controller. The controller may use the signal to determine whether the fluid has completely evolved into steam before exiting the distal end of the heating chamber. Sensing whether saline has been completely converted to steam may be particularly useful for many surgical applications, such as in ablation of various tissues, where delivering high quality (low water content) steam results in more effective treatment. In some embodiments, the heating chamber includes at least one sensor 137. In various embodiments, the at least one sensor 137 comprises an impedance, temperature, pressure, or flow sensor, with a pressure sensor being less preferred. In one embodiment, the electrical impedance of the electrode arrays 136, 138 may be sensed. In other embodiments, the temperature of the fluid, the temperature of the electrode array, the fluid flow rate, the pressure, or similar parameters may be sensed.

Fig. 1H and 1I illustrate multi-lumen balloon catheters 161 and 171, respectively, according to embodiments of the present disclosure. The catheters 161, 171 each include an elongate body 162, 172 having proximal and distal ends. The conduits 161, 171 include at least one positioning element near their distal ends. In various embodiments, the positioning element is a balloon. In some embodiments, the catheter includes more than one positioning element.

In the embodiment shown in fig. 1H and 1I, the catheters 161, 171 each include a proximal balloon 166, 176 and a distal balloon 168, 178, the proximal and distal balloons 166, 176, 168, 178 being positioned near the distal ends of the bodies 162, 172 with a plurality of infusion ports 167, 177 being located between two balloons 166, 176 and 168, 178 on the bodies 162, 172. The body 162, 172 also includes at least one heating compartment 130 proximate the proximal balloon 166, 176 and just proximal to the proximal balloon 166, 176. The embodiment of fig. 1H shows one heating compartment 130 included in the body 165, the heating compartment 130 being proximate to the proximal balloon 166 and just proximal to the proximal balloon 166. In some embodiments, a plurality of heating chambers are arranged in series in the body of the conduit.

In the embodiment of fig. 1I, two heating chambers 130 are disposed in the body 172, proximate to the proximal balloon 176 and just proximal to the proximal balloon 176. Referring to fig. 1I, to expand the bladders 176, 178 and provide current and liquid to the conduit 171, a fluid pump 179, an air pump 173, and an RF generator 184 are coupled to the proximal end of the body 172. The air pump 173 pumps air through the first lumen (extending along the length of the body 172) via the first port to expand the balloons 176, 178 so that the catheter 171 is held in place for ablation treatment. In another embodiment, the catheter 171 includes additional air ports and additional air chambers so that the balloons 176, 178 may individually expand. The fluid pump 179 pumps fluid through a second lumen (extending along the length of the body 172) to the heating chamber 130. The RF generator 184 supplies current to the electrodes 136, 138 (fig. 1G, 1H) causing the electrodes 136, 138 to generate heat, thereby converting fluid flowing through the heating chamber 130 into steam. The generated steam flows through the second lumen and exits port 177. The flexible heating chamber 130 imparts improved flexibility and maneuverability to the catheter 161, 171, allowing a physician to better position the catheter 161, 171 when performing an ablation procedure, such as ablating barrett's esophageal tissue in a patient's esophagus.

Fig. 1J shows catheter 191 with proximal and distal positioning elements 196, 198 and electrode heating chamber 130 according to an embodiment of the present disclosure. Catheter 191 includes an elongate body 192 having a proximal end and a distal end. Catheter 191 includes a proximal positioning element 196 and a distal positioning element 198, with proximal positioning element 196 and distal positioning element 198 positioned near the distal end of body 192, with a plurality of infusion ports 197 located between the two positioning elements 196, 198 on body 192. The body 192 also includes at least one heating compartment 130 within the central lumen. In some embodiments, proximal positioning element 196 and distal positioning element 198 comprise compressible discs that expand upon deployment. In some embodiments, proximal positioning element 196 and distal positioning element 198 are constructed of shape memory metal and are deformable from a first compressed configuration for delivery through a lumen of an endoscope and a second expanded configuration for treatment. In an embodiment, the tray includes a plurality of holes 199 to allow air to escape at the beginning of the ablation procedure and to allow vapor to escape once the pressure and/or temperature within the enclosed treatment volume created between the two positioning elements 196, 198 reaches a predetermined limit, as described above. In some embodiments, conduit 191 includes a filter 193 having micro-holes that provides back pressure to the vapor being delivered, thereby pressurizing the vapor. The predetermined size of the pores in the filter determines the back pressure and thus the temperature of the vapor being produced.

It should be appreciated that the filter 193 may be any structure that allows vapor to flow out of the port and restricts vapor flow back into the conduit or upstream within the conduit. Preferably, the filter is a thin porous metal or plastic structure located in the catheter lumen and adjacent to one or more ports. Alternatively, a one-way valve may be used that allows steam to flow out of the port but not back into the conduit. In one embodiment, the structure 193 (which may be a filter, valve or porous structure) is positioned within 5cm of the port, preferably within 0.1cm to 5cm from the port, and more preferably within less than 1cm from the port, which is defined as the actual opening through which vapor may flow out of the catheter and into the patient.

Fig. 1K illustrates an ablation system 101 suitable for ablating prostate tissue according to some embodiments of the present description. The ablation system 101 includes a catheter 102 having an internal heating chamber 103, the internal heating chamber 103 being disposed within a lumen of the catheter 102 and configured to heat a fluid provided to the catheter 102 to change the fluid to steam for ablation therapy. In one embodiment, the fluid is conductive brine and is converted to non-conductive or poorly conductive vapor. In one embodiment, the electrical conductivity of the fluid (e.g., saline) is reduced by at least 25%, preferably by 50%, more preferably by 90%, as determined by comparing the electrical conductivity of the fluid (e.g., vapor) prior to passage through the heating chamber with the electrical conductivity of the ablative agent (e.g., vapor) after passage through the heating chamber. It should also be understood that for each of the embodiments disclosed in this specification, the term ablative agent preferably refers only to heated steam or vapor and the inherent thermal energy stored therein, without any enhancement from any other energy source (including radio frequency, electrical, ultrasound, optical or other energy modalities).

In some embodiments, the catheter 102 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. A plurality of openings 104 are located near the distal end of the catheter 102 for enabling a plurality of associated thermally conductive elements (such as needles 105) to extend (at an angle to the catheter 102, wherein the angle ranges between 30 degrees and 90 degrees) and be deployed or retracted through the plurality of openings 104. According to one aspect, the plurality of retractable needles 105 are hollow and include at least one injection port 106 to allow passage as the needles 105 are extended and deployed through the plurality of openings 104 in the elongate body of the catheter 102Needle 105 delivers an ablative agent, such as steam or vapor. In some embodiments, the infusion port is positioned along the length of the needle 105. In some embodiments, the infusion port 106 is positioned at the distal tip of the needle 105. During use, such as water, air or CO ₂ Through optional port 107 to cool conduit 102. Steam for ablation and a cooling fluid for cooling are supplied to the catheter 102 at the proximal end of the catheter 102. A fluid, such as brine, is stored in a reservoir (such as brine pump 14) connected to conduit 102. The delivery of the ablative agent is controlled by the controller 15 and the treatment is controlled by the treating physician via the controller 15. The controller 15 includes at least one processor 23 in data communication with the brine pump 14 and a conduit connection port 21 in fluid communication with the brine pump 14. In some embodiments, at least one optional sensor 22 monitors changes in the ablation zone to direct the flow of the ablative agent. In some embodiments, the optional sensor comprises at least one of a temperature sensor or a pressure sensor. In some embodiments, conduit 102 includes a filter 16 having micropores that provide a back pressure to the delivered vapor, thereby pressurizing the vapor. The predetermined size of the pores in the filter determines the back pressure and thus the temperature of the vapor being produced. In some embodiments, the system further comprises a foot pedal 25 in data communication with the controller 15, a switch 27 on the conduit 102, or a switch 29 on the controller 15 for controlling the steam flow. In some embodiments, the needle has a mechanism attached to change its direction from being relatively parallel to the catheter to an angle of between 30 ° -90 ° with the catheter. In one embodiment, the mechanism is a pull wire. In some embodiments, the opening in the catheter is shaped to change the direction of the needle from being relatively parallel to the catheter to an angle of between 30 ° -90 ° with the catheter.

In one embodiment, a user interface included in microprocessor 15 allows the physician to define the device, organ, and condition, which in turn creates default settings for temperature, circulation, volume (sound), and standard RF settings. In one embodiment, these default values may be further modified by the physician. The user interface also includes a standard display of all key variables, as well as warnings if the value exceeds or falls below a certain level.

Fig. 1L illustrates another view of the catheter 102 of fig. 1K, according to some embodiments of the present description. Catheter 102 includes an elongate body 108 having a proximal end and a distal end. A plurality of openings 104 are located near the distal end of the catheter 102 for enabling a plurality of associated thermally conductive elements (such as needles 105) to extend (at an angle to the catheter 102, wherein the angle ranges between 10 degrees and 90 degrees) and be deployed or retracted through the plurality of openings 104. According to one aspect, the plurality of retractable needles 105 are hollow and include at least one injection port 106 to allow for delivery of an ablative agent, such as steam or vapor, through the needles 105 as the needles 105 are extended and deployed through the plurality of openings 104 on the elongate body of the catheter 102. In some embodiments, the infusion port is positioned along the length of the needle 105. In some embodiments, the infusion port 106 is positioned at the distal tip of the needle 105. Optionally during use, such as water, air or CO ₂ Through optional port 107 to cool conduit 102. The body 108 includes at least one heating chamber 103 that is adjacent to and just proximal to the optional port 107 or opening 104. In an embodiment, the heating compartment 103 comprises two electrodes 109 configured to receive RF current, heat, and convert a supplied fluid (e.g., saline) into steam or vapor for ablation.

Referring to fig. 1L, to provide current to catheter 102, fluid for ablation, and optionally cooling fluid, RF generator 184, first fluid pump 174, and second fluid pump 185 are coupled to the proximal end of body 108. The first fluid pump 174 pumps a first fluid (e.g., saline) through a first lumen (extending along the length of the body 108) to the heating compartment 103. The RF generator 184 supplies current to the electrode 109, causing the electrode 109 to generate heat, thereby converting the fluid flowing through the heating chamber 103 into steam. The generated vapor flows through the first lumen, opening 104, needle 105, and exits infusion port 106 to ablate the prostate tissue. Optionally, in some embodiments, a second fluid pump 185 pumps a second fluid (e.g., water) through a second lumen (extending along the length of the body 108) to the optional port 107, where the second fluid exits the catheter 102 to circulate in and cool the ablation zone. The flexible heating chamber 103 imparts improved flexibility and maneuverability to the catheter 102, allowing a physician to better position the catheter 102 when performing an ablation procedure, such as ablating prostate tissue of a patient.

Fig. 1M shows a system 100M for prostate tissue ablation according to another embodiment of the present description. The system 100m includes a catheter 101m, and in some embodiments, the catheter 101m includes a handle 190m having actuators 191m, 192m, the actuators 191m, 192m for extending at least one needle 105m or more from the distal end of the catheter 101m and expanding the positioning element 11m at the distal end of the catheter 101 m. In some embodiments, actuators 191m and 192m may be one of a knob or slider or any other type of switch or button to enable at least one needle 105m or multiple needles to extend. The steam delivery via conduit 101m is controlled by controller 15 m. In an embodiment, the catheter 101m includes an outer sheath 109m and an inner catheter 107m. The needle 105m extends from the inner catheter 107m at the distal end of the sheath 109m, or in some embodiments, through an opening near the distal end of the sheath 109m. In an embodiment, the positioning element 11m is expandable, positioned at the distal end of the inner catheter 107m, and may be compressed within the outer sheath 109m for delivery. In some embodiments, actuator 191m comprises a knob that is rotated a first degree, e.g., a quarter turn, to retract outer sheath 109m. When the outer sheath 109m is retracted, the positioning element 11m is exposed. In an embodiment, the positioning element 11m comprises a disc or cone configured as a bladder anchor. In an embodiment, the actuator/knob is rotated a second extension, e.g., a second quarter turn, to further retract the outer sheath 109m to deploy the needle 105m. In some embodiments, the number of deployed needles is two or more. In some embodiments, referring to fig. 1M, 4C and 4E simultaneously, one or more needles 105M, 3116a are deployed from the lumen of the inner catheter 107M, 3111a through a slot or opening 3115a in the outer sheath 109M, 3110a, which helps control the needle path and isolate the urethra from vapors. In some embodiments, the opening is covered with a slit cover 3119. In another embodiment, for example, as shown in fig. 4D, sleeve 3116b naturally folds outwardly when outer sheath 3110b is pulled back.

Referring again to fig. 1M, in some embodiments, the catheter 101M includes a port 103M for delivering a fluid (e.g., cooling fluid) during ablation. In some embodiments, port 103m is also configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, port 103m is positioned on handle 190 m. In some embodiments, at least one electrode 113m is positioned at the distal end of catheter 101m proximal of needle 105 m. The electrode 113m is configured to receive an electrical current supplied by a connection line 111m extending from the controller 15m to the conduit 101m to heat and convert a fluid, such as brine supplied via a pipe 112m extending from the controller 15m to the conduit 101 m. The heated fluid or saline is converted to steam or vapor for delivery by needle 105m for ablation.

Fig. 1R illustrates a system 100R for prostate tissue ablation according to another embodiment of the present disclosure. The system 100r includes a catheter 101r, and in some embodiments, the catheter 101r includes a handle 190r, the handle 190r having an actuator 191r, 192r for extending at least one needle 105r or multiple needles from a distal end of the catheter 101r. A drive mechanism disposed within the handle 190r deploys the needle 105r into the end of the catheter shaft 101r and retracts from the end of the catheter shaft 101r. In some embodiments, actuators 191r and 192r may be one of a knob or slider or any other type of switch or button to enable at least one needle 105r or multiple needles to extend. In some embodiments, actuator 191r is a button or switch that allows a physician to initiate treatment from handle 190r and a foot pedal (not shown) using system 100r. In some embodiments, the strain relief mechanism 110r is configured at the distal end of the handle 190r, which connects the handle 190r to the catheter 101r. The strain relief mechanism 110r provides support for the catheter shaft 101r. The delivery of steam via conduit 101r is controlled by controller 15r. A cable subassembly 123r including a cable in handle 190r connects catheter 101r to controller 15r. In an embodiment, the catheter 101r includes an outer sheath 109r and an inner catheter (not shown).

In various embodiments, the controller 15r (and 15, 15M, 15P, 15Q, and 2252 of fig. 1A, 1K, and 1N, 1M, 1P, 1Q, and 22B, respectively) of the system of the present description includes a computing device having one or more processors or central processing units, one or more computer-readable storage media (such as RAM, hard disk, or any other optical or magnetic medium), a controller (such as an input/output controller), at least one communication interface, and a system memory. The system memory includes at least one Random Access Memory (RAM) and at least one Read Only Memory (ROM). In an embodiment, the memory includes a database for storing raw data, images, and data related to the images. The plurality of functional and operational elements communicate with a Central Processing Unit (CPU) to effect operation of the computing device. In various embodiments, the computing device may be a conventional stand-alone computer, or alternatively, the functionality of the computing device may be distributed across networks of multiple computer systems and architectures and/or cloud computing systems. In some embodiments, execution of a plurality of program instructions or code sequences stored in one or more non-volatile memories enables or causes a CPU of a computing device to perform the various functions and processes as described herein. In alternative embodiments, hard-wired circuitry may be used in place of or in combination with software instructions to implement the processes of the systems and methods described herein. Thus, the described systems and methods are not limited to any specific combination of hardware and software.

The needle tip assembly 125r is positioned within a needle chamber 108r within the outer sheath 109r. Needle chamber 108r may be a metal or plastic sleeve configured to receive needle 105r during delivery to aid in needle deployment and retraction, and is further described with reference to fig. 1T. The needle tip assembly 125r, including the needle 105r, extends from the inner catheter at the distal end of the sheath 109r or in some embodiments through an opening near the distal end of the sheath 109r when pushed out of its lumen 108 r. In an embodiment, the positioning element is also provided at the distal end of the inner catheter. The positioning element may be expandable and may be compressed within the outer sheath 109r for delivery. In some embodiments, the actuator 192r includes a knob that is rotated a first degree, e.g., a quarter turn, to retract the outer sheath 109r. When the outer sheath 109r is retracted, the positioning element is revealed. In an embodiment, actuator/knob 192r is rotated a second extension, e.g., a second quarter turn, to further retract outer sheath 109r to deploy needle 105r. In some embodiments, the number of deployed needles is two or more. In some embodiments, referring to fig. 1R, 4C, and 4E simultaneously, one or more needles 105R, 3116a are deployed from the lumen of the inner catheter 3111a through slots or openings 3115a in the outer sheaths 109R, 3110a, which helps control needle path and isolate the urethra from vapors. In some embodiments, the opening is covered with a slit cover 3119. In another embodiment, for example, as shown in fig. 4D, sleeve 3116b naturally folds outwardly when outer sheath 3110b is pulled back.

Fig. 1R shows a perspective view of a needle tip assembly 125R that includes a needle 105R attached to a needle attachment member 107R, in some embodiments, the needle attachment member 107R includes a metal threaded fitting, and is described in further detail with reference to fig. 1S. A needle attachment member or threaded fitting 107r connects the needle 105r to the catheter 101r. In an embodiment, the needle attachment member 107r includes a threaded surface fixedly attached to the end of the catheter 101r and configured to have a needle 105r threaded thereto. In some embodiments, needle 105r is a 22 to 25G needle. In some embodiments, needle 105r has a coating gradient for insulation or echogenicity. The insulating coating 106r may be ceramic, polymer, or any other material suitable for coating the needle 105r and providing insulation and/or echogenicity to the needle 105r. A coating is provided at the base of the needle 105r to alter the length of the needle tip.

Referring again to fig. 1R, in some embodiments, the catheter 101R includes a tubing and connector subassembly (port) 103R for delivering a fluid, such as a cooling fluid, during ablation. In some embodiments, port 103r is further configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, port 103r is positioned on handle 190 r. In some embodiments, one or more of the electricity The pole 113r is positioned at the distal end of the catheter 101r near the one or more needles 105 r. The one or more electrodes 113r are configured to receive current supplied by a connection line 111r extending from the controller 15r to the conduit 101r to heat and convert fluid, such as brine, supplied via a conduit 112r extending from the controller 15r to the conduit 101 r. The heated fluid or saline is converted to steam or vapor for delivery by needle 105r for ablation.

Fig. 1S illustrates a needle attachment component 107S of a system 100S for prostate tissue ablation according to some embodiments of the present description. In a preferred embodiment, a needle attachment member 107s having a lumen 117s defining a lumen is fixedly attached to an end of the inner catheter 119s such that the lumen 129s of the inner catheter 119s is in fluid communication with the lumen 117s of the needle attachment member 107s. Preferably, needle attachment member 107s has a plurality of threads on its distal outer surface 127s to which needle 105s can be screwed. It is also preferred that the needle attachment member 107s is made of the same material as the needle 105s, preferably metal, more preferably stainless steel.

Importantly, the proximal portion 137s of the needle attachment member 107s is spaced apart from the one or more electrodes 113s by a very specific extent. Too close and power from the electrode 113s may flow into the needle attachment member 107s, into the needle 105s, and to the patient's tissue. The steam that is too far and generated by the electrode 113s may heat the length of the inner catheter 119s and the outer catheter 109s between the electrode 113s and the needle attachment component 107s, exposing tissue that should not be ablated to excessive heat may result in stenosis and also in premature condensation of the steam before passing through the needle 105s, thus resulting in a sufficient amount of steam reaching the tissue to be ablated. Thus, in a preferred embodiment, the distal-most electrode 133s of the plurality of electrodes 113s located within the catheter lumen 129s is separated by a distance of at least 0.1mm to a distance of no more than 60mm by the proximal-most portion 137s of the needle attachment member 107s. These distance ranges ensure that: a) no power is delivered to the tissue with or independent of the steam, b) a sufficient amount of steam is delivered to the tissue to be ablated, and c) the distance between the steam generation point and the needle attachment member 107s is small, thereby ensuring that the associated catheter length is not overheated and that tissue contacting the catheter length is not excessively ablated.

Needle 105s is defined by a metal housing 115s, a lumen 125s therethrough, a sharp and preferably tapered tip 135s, and a proximal base 145s, proximal base 145s configured to pass through or otherwise attach to needle attachment member 107s. Needle 105s also bends in a first direction extending away from the axial length of catheter 109 s. In one embodiment, the needle 105s has a bending capability that varies according to the bending direction. For example, the needle 150s may be more easily bent in a plane parallel to the first direction, as opposed to a plane perpendicular to the first direction. Alternatively, the needle 105s may be more easily bent in a plane perpendicular to the first direction, as opposed to a plane parallel to the first direction. Alternatively, the case 143s of the electrode 113s may also be bent more easily in one direction than in the other direction. For example, the electrode housing 143s may also be more easily bent in a plane perpendicular to the first direction, as opposed to a plane parallel to the first direction. Alternatively, the electrode housing 143s may also be more easily bent in a plane parallel to the first direction opposite to a plane perpendicular to the first direction. In an embodiment, a length of tubing 112s at the proximal end of the catheter handle 190s provides saline to the catheter for conversion to steam. In an embodiment, dial 192s on handle 190s may be rotated by a user to advance or retract lead screw 193s attached to inner catheter 119s to expose or retract needle 105s from outer catheter 109 s. In some embodiments, the outer conduit 109s comprises a hypotube having an outer diameter of 3mm and an inner diameter of about 2.5 mm. In some embodiments, needle 105s is a 25 gauge needle.

Fig. 1T illustrates a needle chamber 108T of a system for prostate tissue ablation according to some embodiments of the present description. In an embodiment, the catheter further comprises a retractable needle chamber 108t configured to be positioned over the needle 105t and the needle attachment member (107S in fig. 1S). Needle chamber 108t may be retracted using a control on the handle and once retracted, needle 105t will be exposed. To ensure that the needle 105t maintains the correct radius, degree, or extent of curvature, in operation, the needle 105t preferably has a first radius, degree, or extent of curvature prior to deployment and prior to positioning in the needle chamber 108t. Prior to positioning within a patient, a needle 105t having a first radius, degree, or extent of curvature is enclosed within the needle chamber 108t and covered by the needle chamber 108t, resulting in the needle 105t adopting a second radius, degree, or extent of curvature. Finally, in use and while in the patient, the needle chamber 108t may be retracted to expose the needle. In so doing, the needle 105t will adopt a third radius, degree, or extent of curvature. In this embodiment, the first radius, degree, or extent of curvature is greater than the third radius, degree, or extent of curvature, which is greater than the second radius, degree, or extent of curvature. In other words, the first radius, degree, or extent of curvature is greatest, the third radius, degree, or extent of curvature is smallest, and the second radius, degree, or extent of curvature is in between.

Needle chamber 108t is preferably cylindrical having an inner surface 118t, which inner surface 118t has a higher hardness or stiffness relative to its outer surface 128 t. Preferably, the outer surface 128t is made of a polymer and the inner surface 118t comprises a metal. This allows the outer needle lumen surface 128t to be atraumatic and reduces the likelihood of injury to the patient, while the inner needle lumen surface 118t prevents inadvertent puncturing or damage to the needle 105t itself.

In another embodiment, needle chamber 108t may be configured to receive needle 105t such that it conforms to the curvature of needle 105 t. Thus, in one embodiment, lumen 138t of needle chamber 108t is curved, reflecting, at least to some extent, the curvature of needle 105 t.

Finally, insulator 175t is positioned along the length of needle 105t and on outer surface 185t of needle 105 t. A sufficient amount of insulator 175t is used to protect the tissue that should not be ablated and improve the dynamics of the vapor distribution. The insulator preferably extends at least 5% along the length of the needle 105t and no more than 90% along the length of the needle 105t, and more preferably at least 5% along the length of the needle 105t and no more than 75% along the length of the needle 105t, measured from the proximal end of the needle 105 t.

Fig. 1U illustrates a needle chamber 108U of a system for prostate tissue ablation according to some embodiments of the present description. The needle chamber 108u is provided in the form of a spherical tip attached at the distal end of the catheter body 109 u. In an embodiment, the catheter includes a retractable needle chamber 108u configured to be positioned over the needle 105u and the needle attachment member (107S in fig. 1S). Needle chamber 108u may be retracted using a control on the handle and once retracted, needle 105u will be exposed. To ensure that the needle 105u maintains the correct radius, degree, or extent of curvature, in operation, the needle 105u preferably has a first radius, degree, or extent of curvature prior to deployment and prior to positioning in the needle chamber 108u. Prior to positioning within the patient, the needle 105u having a first radius, degree, or extent of curvature is enclosed within the needle chamber 108u and covered by the needle chamber 108u, resulting in the needle 105u adopting a second radius, degree, or extent of curvature. Finally, in use and while in the patient, the needle chamber 108u may be retracted to expose the needle. In so doing, the needle 105u will adopt a third radius, degree or extent of curvature. In this embodiment, the first radius, degree, or extent of curvature is greater than the third radius, degree, or extent of curvature, which is greater than the second radius, degree, or extent of curvature. In other words, the first radius, degree, or extent of curvature is greatest, the third radius, degree, or extent of curvature is smallest, and the second radius, degree, or extent of curvature is in between.

Needle chamber 108u is preferably cylindrical with an inner surface 118u having a higher hardness or stiffness relative to its outer surface 128 u. Preferably, the outer surface 128u is made of a polymer and the inner surface 118u comprises a metal. This allows the outer needle lumen surface 128u to be atraumatic and reduces the likelihood of injury to the patient, while the inner needle lumen surface 118u prevents inadvertent puncturing or damage to the needle 105u itself.

In another embodiment, needle chamber 108u may be configured to receive needle 105u such that it conforms to the curvature of needle 105 u. Thus, in one embodiment, lumen 138u of needle chamber 108u is curved, reflecting, at least to some extent, the curvature of needle 105 u.

Fig. 1N illustrates an ablation system 110 suitable for ablating endometrial tissue in accordance with an embodiment of the present disclosure. The ablation system 110 includes a catheter 111 having a catheter body 115, the catheter body 115 including an outer catheter 116, the outer catheter 116 having an inner catheter 117, the inner catheter 117 being concentrically positioned within the distal end of the outer catheter 116 and extendable outwardly from the distal end of the outer catheter 116. The inner catheter 117 comprises at least a first distal attachment or positioning element 112 and a second proximal attachment or positioning element 113. During positioning of catheter 111 within the cervix or uterus of a patient, inner catheter 117 is positioned within outer catheter 116. During positioning of the catheter 111, the first positioning element 112 and the second positioning element 113 in the first compressed configuration are constrained by the outer catheter 116 and positioned within the outer catheter 116. Once the distal end of outer catheter 111 has been positioned within the cervix of the patient, inner catheter 117 extends distally from the distal end of outer catheter 116 and into the uterus of the patient. The first positioning element 112 and the second positioning element 113 expand and deploy in the uterus. In an embodiment, the first positioning element 112 and the second positioning element 113 include shape memory properties allowing them to expand once deployed. In some embodiments, the first positioning element 112 and the second positioning element 113 are composed of nitinol. In some embodiments, the first distal positioning element 112 is configured to contact the uterine wall once deployed, thereby positioning the inner catheter 117 within the uterus, and the second proximal positioning element 113 is configured to abut a distal portion of the cervix within the uterus once deployed, thereby blocking the return of ablation vapors into the cervical os. The internal heating chamber 103 is disposed within the lumen of the inner catheter 117 and is configured to heat the fluid provided to the catheter 111 to change the fluid to steam for ablation therapy. In some embodiments, the internal heating chamber is positioned distal to the second positioning element 113. In some embodiments, the catheter 111 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. The inner catheter 117 includes one or more infusion ports 114 for infusing an ablative agent (e.g., vapor). In some embodiments, one or more infusion ports 114 are positioned on the catheter 111 between the first positioning element 112 and the second positioning element 113. In various embodiments, the first distal attachment or positioning element 112 and the second positioning element 113 comprise discs. A fluid such as brine is stored in a reservoir (such as brine pump 14) connected to the conduit 111. The delivery of the ablative agent is controlled by the controller 15 and the treatment is controlled by the treating physician via the controller 15. The controller 15 includes at least one processor 23 in data communication with the brine pump 14 and a conduit connection port 21 in fluid communication with the brine pump 14. In some embodiments, at least one optional sensor 22 monitors changes in the ablation zone to direct the flow of the ablative agent. In some embodiments, the optional sensor comprises at least one of a temperature sensor or a pressure sensor. In some embodiments, the conduit 111 includes a filter 16 having micropores that provide a back pressure to the delivered vapor, thereby pressurizing the vapor. The predetermined size of the pores in the filter determines the back pressure and thus the temperature of the vapor being produced. In some embodiments, the system further comprises a foot pedal 25 in data communication with the controller 15, a switch 27 on the conduit 111, or a switch 29 on the controller 15 for controlling the steam flow.

In another embodiment, outer catheter 116 abuts the cervical canal mucosa without occluding the cervix and exudates from the uterine cavity. The space between outer catheter 116 and inner catheter 117 allows ventilation through the channel to allow heated air, steam or fluid to escape from the uterine cavity without contacting and damaging the cervical canal.

FIG. 1O illustrates another view of the catheter 111 of FIG. 1N according to some embodiments of the present description. The catheter 111 includes an elongate body 115 having a proximal end and a distal end. At the distal end, catheter body 115 includes an outer catheter 116, outer catheter 116 having an inner catheter 117, inner catheter 117 being concentrically positioned within the distal end of outer catheter 116 and extendable outwardly from the distal end of outer catheter 116. The inner catheter 117 includes a distal positioning element 112 near its distal end, and a proximal positioning element 113 near the distal positioning element 112. In various embodiments, the positioning element is a disk. The outer conduit 116 is configured to receive the inner conduit 117 and constrain the positioning elements 112, 113 prior to positioning, as described above. A plurality of infusion ports 114 are located on the inner catheter 117 between the two positioning elements 112, 113. The inner catheter 117 also includes at least one heating chamber 103 just distal to the proximal disc 113. In some embodiments, the heating compartment 103 includes two electrodes 109 configured to receive RF current, heat, and convert a supplied fluid (e.g., saline) to steam or vapor for ablation.

Referring to fig. 1O, to provide current and liquid to catheter 111, fluid pump 174 and RF generator 184 are coupled to the proximal end of body 115. The fluid pump 174 pumps fluid, such as saline, through the first lumen (extending along the length of the body 115) to the heating compartment 103. The RF generator 184 supplies current to the electrode 109, causing the electrode 109 to generate heat, thereby converting the fluid flowing through the heating chamber 103 into steam. The generated steam flows through the first lumen and out of port 114 to ablate endometrial tissue. The flexible heating chamber 103 imparts improved flexibility and operability to the catheter 111, allowing a physician to better position the catheter 111 when performing an ablation procedure, such as ablating endometrial tissue of a patient.

In various embodiments, the heating electrode 109 extends proximally of the proximal positioning element 113, beyond the distal end of the proximal positioning element 113, or entirely distal of the distal end of the proximal positioning element 113, but does not extend substantially beyond the proximal end of the distal positioning element 112.

Fig. 1P shows a system 100P for endometrial tissue ablation according to another embodiment of the present disclosure. The ablation system 100p includes a catheter 101p, and in some embodiments, the catheter 101p includes a handle 190p having actuators 191p, 192p, 193p for pushing forward the distal spherical tip 189p of the catheter 101p and for deploying the first distal positioning element 11p and the second proximal positioning element 12p at the distal end of the catheter 101 p. In an embodiment, the catheter 101p includes an outer sheath 109p and an inner catheter 107p. In an embodiment, catheter 101p includes cervical collar 115p, cervical collar 115p being configured to abut an external port once catheter 101p has been inserted into the uterus of a patient. In an embodiment, the distal first positioning element 11p and the proximal second positioning element 12p are expandable, positioned at the distal end of the inner catheter 107p, and may be compressed within the outer sheath 109p for delivery. In some embodiments, actuators 192p and 193p comprise knobs. In some embodiments, actuator/knob 192b is used to deploy the distal first positioning element 11p. For example, in an embodiment, actuator/knob 192p is rotated a quarter turn to deploy distal first positioning element 11p. In some embodiments, an actuator/knob 193b is used to deploy the proximal second positioning element 12p. For example, in an embodiment, actuator/knob 193p is rotated a quarter turn to deploy proximal second positioning element 12p. In some embodiments, the handle 190p includes only one actuator/knob 192p that rotates a first quarter turn to deploy the first distal positioning element 11p and then rotates a second quarter turn to deploy the second proximal positioning element 12p. In other embodiments, other combinations of actuators/knobs are used to deploy one or both of the first distal positioning element 11p and the second proximal positioning element 12p. In some embodiments, the catheter 101p includes a port 103p for delivering a fluid (e.g., cooling fluid) during ablation. In some embodiments, port 103p is further configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, port 103p is positioned on handle 190 p. In some embodiments, at least one electrode 113p is positioned at the distal end of catheter 101p, proximal of proximal second positioning element 12 p. The electrode 113p is configured to receive an electrical current supplied by a connection line 111p extending from the controller 15p to the conduit 101p to heat and convert a fluid, such as brine supplied via a conduit 112p extending from the controller 15p to the conduit 101 p. The heated fluid or saline is converted to steam or vapor for ablation delivery through port 114 p. In some embodiments, the catheter 101p is made of or covered with an insulating material to prevent ablation energy from the catheter bodyEscaping. A plurality of small delivery ports 114p are located on the inner catheter 107p between the distal first positioning element 11p and the second proximal positioning element 12 p. Port 114p is used to inject an ablative agent, such as steam. The delivery of the ablative agent is controlled by controller 15p and the treatment is controlled by the treating physician via controller 15 p.

Fig. 1Q shows a controller 15Q for use with an ablation system according to an embodiment of the present disclosure. Similar to controllers 15m, 15r, and 15p, controller 15q controls delivery of the ablative agent to the ablation system. Thus, the controller 15q provides the physician with a control interface for controlling the ablation therapy. An input port 196q on the controller 15q provides a port for connecting the controller 15q to a catheter and providing electrical signals to the catheter. A fluid port 198q on the controller 15q provides a port for connecting a fluid supply, such as saline, to the catheter through a conduit. In an embodiment, a Graphical User Interface (GUI) 1100q on the controller 15q shows settings for operating the ablation system, which may be used and/or modified by the physician during use. In some embodiments, the GUI is a touch screen that allows a user to control the system.

Fig. 2A and 2B illustrate a single balloon catheter 245a and a coaxial double balloon catheter 245B according to embodiments of the present description. The conduits 245a, 245b include an elongate body 246, the elongate body 246 having a proximal end 252 and a distal end 253, and first lumen 255, second lumen 256, and third lumen 257 therein. In one embodiment, the elongated body 246 is insulated. The conduits 245a, 245b include at least one positioning element 248 near their distal ends 253. In various embodiments, the positioning element is an expandable balloon. In some embodiments, the catheter includes more than one positioning element. As shown in fig. 2B, coaxial conduit 245B includes an outer conduit 246B that houses an elongated body 246.

In the embodiment shown in fig. 2A, 2B, the catheter 245a, 245B includes a proximal first expandable balloon 247 and a distal second expandable balloon 248 positioned near the distal end of the body 246, with a plurality of infusion ports 249 positioned on the body 246 between the two balloons 247, 248. It should be appreciated that while balloons are preferred, other positioning elements as previously described may be used.

The body 246 includes a first lumen 255 (extending along a portion of the entire length of the body 246), the first lumen 255 being in fluid communication with a first input port 265 at the proximal end 252 of the catheter body 246 and with the proximal first bladder 247 to expand or contract the proximal first bladders 247, 248 by supplying or drawing air through the first lumen 255. In one embodiment, the use of a dual balloon catheter as shown in FIGS. 2A and 2B results in a seal being formed and a radius of 3cm, a length of 9cm, and a surface area of 169.56cm ² The treatment volume is 254.34cm ³ Is provided. The body 246 includes a second lumen 256 (extending along the entire length of the body 246), the second lumen 256 being in fluid communication with a second input port 266 at the proximal end 252 of the catheter body 246 and with the distal second balloon 248 to expand or contract the distal second balloon 248 by supplying or drawing air through the second lumen 256. In another embodiment, the body includes only a first lumen for fluid communication with the proximal end of the catheter and the first and second balloons for inflation and deflation of the balloons. The body 246 also includes an in-line heating element 250 disposed within a second third lumen 257 (extending along the length of the body 246), the second third lumen 257 being in fluid communication with a third input port 267 at the proximal end 252 of the catheter body 246 and with the infusion port 249. In one embodiment, the heating element 250 is positioned within the third lumen 257, proximate to the infusion port 249 and just proximal to the infusion port 249. In one embodiment, the heating element 250 includes a plurality of electrodes. In one embodiment, the electrodes of heating element 250 are folded back and forth to increase the surface contact area of the electrodes with the liquid supplied to third lumen 257. The second third lumen 257 is used to supply a liquid, such as water/saline, to the heating element 250.

In various embodiments, the heating element 250 is spaced from the nearest port 249 by a distance in the range of 1mm to 50cm, depending on the type of therapeutic procedure to be performed.

A fluid pump, an air pump, and an RF generator are coupled to the proximal end of the body 246. The air pump pushes air through the first and second lumens via the first and second inputs 265, 266 to expand the balloons 247, 248 so that the catheters 245a, 245b remain in place for ablation therapy. A fluid pump pumps a liquid, such as water/brine, through the second third lumen 257 to the heating element 250 via the third input 267. The RF generator supplies power and current to the electrodes of the heating element 250, thereby heating the electrodes and converting liquid (flowing around the heating element 250) into vapor. In other embodiments, the electrodes use resistive heating or ohmic heating to heat the fluid. The generated steam exits port 249 for ablation treatment of the target tissue. In an embodiment, the supply of liquid and current, and thus the delivery of vapor, is controlled by a microprocessor.

Ablation of the prostate

Fig. 3A shows a typical anatomy of the prostate region for descriptive purposes. Fig. 3B and 3C show exemplary transparent views of the anatomy of the prostate 302 highlighting peripheral region (PZ) 316 in addition to other regions in the periphery of the prostate 302. Referring to the drawings, embodiments of the present description allow for ablation of the prostate 302 by ablating PZ 316 prostate tissue. According to various embodiments of the present description, embodiments are capable of ablating prostate 302 tissue without completely ablating Central Zone (CZ) 318 prostate tissue so as not to damage the ejaculatory duct 304, emerging from the duct of the seminal vesicle 306, which may result in stenosis of the ejaculatory duct 304. For purposes of this specification, "complete ablation" is defined as ablating more than 55% of the surface area or volume surrounding the anatomy.

Embodiments of the present description enable the ablation of prostate 302 tissue to treat prostate 302 by ablating one of a plurality of anatomical structures along various treatment paths. Fig. 3A shows a path 310 along the urethra, also known as a transurethral method, as an exemplary path into the prostate region for ablation. An alternate path 312 is shown through the wall between the rectum 314 and the prostate 302. In embodiments, the prostate 302 tissue is ablated through the urethra 308 or through the wall from the rectum 314. In either case, embodiments of the present disclosure ensure that greater than 0% and less than 75% of the circumference of the periurethral region 324, CZ 318, or any other region is ablated during ablation of the prostate 302. In another embodiment, the prostate enters from the base of the bladder around the bladder neck without passing through the prostatic urethra, thereby avoiding the risk of ablating and stenosing the prostatic urethra. The method is preferably reserved for ablating benign or malignant obstruction caused by disease in the central region of the prostate or by middle lobe hypertrophy.

In one embodiment, the ejaculatory duct 304 is an ablated anatomical structure. In another embodiment, the urethra 308 is ablated without completely ablating the circumference of the urethra 308 so as not to cause stenosis of the urethra 308. In other embodiments, the anatomical structure being ablated may include the envelope of the prostate, including the rectal wall. In some embodiments, a portion of the prostate 302 or a portion of one or more of the CZ 318, PZ 316, transition Zone (TZ) 320, and anterior fibromuscular layer (AFS) 322 is ablated. The different anatomical structures are ablated without ablating a continuous circumference of the periurethral region (PuZ) 324 around the urethra 308. In some embodiments, greater than 0% and no more than 90% of the circumference of the continuous PuZ 324 is ablated. In some embodiments, greater than 0% and less than 75% of the circumference of the continuous PuZ 324 is ablated. In some embodiments, greater than 0% and less than 25% of the circumference of the continuous PuZ 324 is ablated.

Thus, in one embodiment, the CZ 318 of the prostate 302 is ablated while more than 0% and less than 75% of the continuous circumference of the prostatic urethra 308 is ablated. In another embodiment, the CZ 318 of the prostate 302 is ablated while ablating greater than 0% of the continuous circumference of the ejaculatory duct 304 and less than 75% of the continuous circumference of the ejaculatory duct 304. In one embodiment, the TZ 320 of the prostate 302 is ablated while more than 0% and less than 75% of the continuous circumference of the prostatic urethra 308 is ablated. In another embodiment, the TZ 320 of the prostate 302 is ablated while ablating greater than 0% of the continuous circumference of the ejaculatory duct 304 and less than 75% of the continuous circumference of the ejaculatory duct 304. In another embodiment, the middle lobe of the prostate 302 is ablated while ablating greater than 0% of the continuous circumference of the ejaculatory duct 304 and less than 75% of the continuous circumference of the ejaculatory duct 304. In one embodiment, a majority (ranging from greater than 25% to greater than 75%) of the middle leaf or CZ 318 is ablated without ablating a majority (greater than 75%) of PuZ 324. In one embodiment, a majority (ranging from greater than 25% to greater than 75%) of the TZ 320 is ablated without ablating a majority (. Gtoreq.75%) of the AFS 322. In some embodiments, preferably, a range of 1% to 25% of the continuous circumference of the prostatic urethra and each increment therein is ablated. In some embodiments, it is preferred to ablate the range of 1% to 25% of the continuous circumference of the ejaculatory duct and each increment therein. In some embodiments, it is preferable to ablate a range of 1% to 25% of a thickness of the rectal wall and each increment therein. In various embodiments, the mucosal layer of the rectal wall is not ablated.

Fig. 4A is a schematic view of a water-cooled conduit 400 according to another embodiment of the present disclosure, and fig. 4B is a cross-section of the end of the conduit 400. Referring now to fig. 4A and 4B, a catheter 400 includes an elongate body 402 having a proximal end and a distal end. The distal end includes a positioning element 404, such as an expandable balloon. A plurality of openings 406 are located near the distal end for enabling a plurality of associated thermally conductive elements 408 (e.g., needles) to extend (from catheter 400 at an angle, where the angle ranges between 10 and 150 degrees) and be deployed or retracted through the plurality of openings 406. According to one aspect, the plurality of retractable needles 408 are hollow and include at least one opening to allow for delivery of an ablative agent, such as vapor or steam 410, through the needles 408 as the needles 408 are extended and deployed through the plurality of openings 406. This is shown in the context of fig. 1L and 1M. The sheath 412 extends distally along the body 402 (including the plurality of openings 406) of the catheter 400. A plurality of openings 406 extend from the body 402 and through the sheath 412 to enable the plurality of needles 408 to extend beyond the sheath 412 when deployed. During use, a cooling fluid, such as water or air 414, is circulated through the sheath 412 to cool the catheter 400. Steam 410 for ablation and cooling fluid 414 for cooling are supplied to catheter 400 at the proximal end of catheter 400.

It should be noted that alternative embodiments may include two positioning elements or balloons, one at the distal end and the other near the opening 406, such that the opening 406 is located between the two balloons.

Fig. 4C shows an embodiment of a distal end of a catheter 400C for use with the system 101M of fig. 1M. In the embodiment shown in fig. 4C, one or more openings 406C are located near the distal end of the outer sheath 412C for enabling one or more associated thermally conductive elements 408C (e.g., needles) to extend from the inner catheter 416C (at an angle to the catheter 400C, where the angle ranges between 10 degrees and 90 degrees) and deploy or retract through the one or more openings 406C. Each needle 408c includes a beveled sharpened edge 418c for piercing prostate tissue and an opening 410c for delivering an ablative agent. In some embodiments, each needle 408c has a coating gradient for insulation or echogenicity. The coating may be ceramic, polymer, or any other material suitable for coating the needle and providing insulation and/or echogenicity to the needle 408 c. A coating is provided at the base of needle 408c to alter the length of the tip. In some embodiments, each needle 408c includes a physical gradient of its shape, such as a taper, an inclined tip, or any other structural gradient, to adjust and manage vapor distribution. In some embodiments, the physical shape of the needle is configured for tissue cutting. The needle edge is configured to pierce tissue without causing shearing or damage to the tissue.

In the multi-needle embodiment shown in fig. 4C, the openings 406C are circumferentially positioned equidistant from each other on the outer sheath 412C. In various embodiments, the opening 406c may be used to extend one or more needles 408c. In other embodiments, the opening 406c and the needle 408c are offset or circumferentially positioned at unequal distances from each other on the outer sheath 412 c. Fig. 4D illustrates other embodiments of the distal end of a catheter 400D for use with the system 101M of fig. 1M. One or more openings 406d are positioned circumferentially around the sheath 412d at equal distances from each other and at the distal edge 420d of the sheath 412d. In some multi-needle embodiments, the plurality of openings 406d positioned circumferentially around the sheath 412d are offset from one another at the distal edge 420d of the sheath 412d and are not always equidistant. The distal end of catheter 400d may also have a coating gradient for insulation or echogenicity. The coating may cover the needle surface in the range of 0% to 100% of the needle surface. In an embodiment, the coating is concentrated at the proximal end of needle 408d to provide insulation for the needle. In some embodiments, the coating is concentrated at the distal end of the needle 408d to impart echogenicity to the needle 408 d. The coating may be ceramic, polymer, or any other material that may provide insulation and/or acoustic echo to the needle 408 d. The coating provides different lengths to the tip at the base of the needle. In some embodiments, the needle has a physical gradient (shape, taper, or any other) to adjust and manage vapor distribution. In some embodiments, the needle tip is shaped for cutting tissue. One or more associated thermally conductive elements 408d (such as needles) are configured to extend from the inner conduit 416d (at an angle to the conduit 400d, wherein the angle ranges between 10 degrees and 90 degrees) and to be deployed or retracted through the one or more openings 406 d. Each needle 408d includes a beveled sharpened edge 418d for piercing prostate tissue and an opening 410d for delivering an ablative agent. Referring concurrently to fig. 4C and 4D, according to one aspect, each retractable needle 408C, 408D is hollow and includes at least one opening 410C, 410D to allow delivery of an ablative agent, such as steam or vapor, through one or more of the needles 408C, 408D as the needles 408C, 408D are extended and deployed through one or more of the openings 406C, 406D. This is further illustrated in the context of fig. 1L and 1M. The outer sheaths 412c, 412d extend distally along the body of the catheters 400c, 400d (including the plurality of openings 406c, 406 d). A plurality of openings 406c, 406d extend from the body and through the sheaths 412c, 412d to enable each of the plurality of needles 408c, 408d to extend beyond the sheaths 412c, 412d when deployed. In some embodiments, the openings 406c, 406d are provided with a locking mechanism for locking the needles 408c, 408d in their deployed positions such that the needles 408c, 408d are prevented from being compressed. In some embodiments, the locking mechanisms operate independently to provide the user with the ability to customize the position of the needles 408c, 408d for the disease location, the amount of ablation, and the orientation of the needles. The locking mechanism is deployed in all embodiments of the present specification for the treatment of various conditions including BPH and AUB. In all of these embodiments, the needle is electrically separated from the steam generating chamber by the length of the catheter so as to electrically isolate the tissue from the RF current delivered to the steam generating chamber.

The size and number of openings 406c, 406d may vary in different embodiments. Furthermore, in various embodiments, the openings 406c, 406d providing outlet ports for vapor may be the same size along the length of the jackets 412c, 412d, and may have different patterns, such as, but not limited to: spiral, circular, or any other pattern. Furthermore, the openings 406c, 406d may have a size gradient to force the vapor to be distributed into certain areas of the anatomy. In an exemplary embodiment, the diameter of the openings 406c, 406d may vary by at least 10% (but not limited to) from top to bottom or bottom to top. In addition, the openings 406c, 406d may have different shapes, such as circular, oval, or any other shape.

Fig. 4E illustrates an embodiment of a slit vane for covering the openings 406C, 406D of fig. 4C and 4D according to some embodiments of the present description. In an embodiment, slit wing 422e is made of a material such as, but not limited to, silicone or Polyurethane (PU). A tab 422e is positioned over each opening 406c, 406 d. Needles 408c, 408d may be extended (at an angle to catheters 400c, 400d, where the angle ranges between 30 and 90 degrees) and deployed or retracted by a plurality of wings 422 e.

Fig. 4F shows an embodiment of a positioning element 424F according to the present description, the positioning element 424F being positioned at the distal end of an ablation catheter to position the ablation catheter in the prostatic urethra. In some embodiments, a positioning element having the same shape as element 424f is also used for endometrial ablation, as described in the embodiments of the present specification. In an embodiment, the positioning element includes a plurality of wires 426f woven in a pattern (e.g., a spiral pattern). In an embodiment, the wire 426f is composed of a shape memory material to allow compression of the positioning element 424f during delivery. In some embodiments, the shape memory material is nitinol. In various embodiments, the positioning element 424f has a funnel, bell, sphere, oval, egg, or acorn shape, and is substantially cylindrical when compressed. When deployed, the positioning element 424f abuts and rests in the bladder or bladder neck.

Fig. 4G-4L illustrate exemplary steps according to the present description, showing one embodiment of ablating prostate tissue 428 using a catheter 400 similar to the catheter shown in fig. 4C, 4D, and 4E. An outer catheter or sheath 412 surrounds the inner catheter 402. Fig. 4G shows the distal end of catheter 400G advanced through prostatic urethra 430G. In an embodiment, catheter 400g includes an elbow tip 432g at its distal end 422g, the elbow tip 432g configured to be pushed through and positioned against a patient's bladder 434 g. In an embodiment, elbow end 432g is curved or elbow end. Fig. 4H shows the distal end of catheter 400H advanced into bladder 434H, and fig. 4I shows the distal end of catheter 400I advanced even further into bladder 434I. As shown in FIGS. 4H and 4I, the outer sheath 412H/412I is retracted slightly to expose the distal end of the inner catheter 402H/402I with the positioning element 424H/424I in the compressed configuration. Referring to fig. 4J, the positioning element 424J is expanded and the catheter 400J is retracted to position the positioning element 424J near the distal end of the bladder neck 436J or the prostatic urethra 430J. Referring to fig. 4K, needle 408K extends from catheter 400K and into prostate tissue 428K. In embodiments, needle 408k refers to at least one needle, and in some embodiments, more than one needle. In an embodiment, needle 408k is deployed and extended according to the embodiments shown in fig. 4A, 4C, and 4D. Referring to fig. 4L, ablative agent 438L is delivered through needle 408L into prostate tissue 428L.

In an alternative embodiment, referring to fig. 4M, catheter 400M has a positioning element 424M, with positioning element 424M positioned on catheter 400M near needle 408M, with needle 408M in turn positioned at the distal end of catheter 400M. In other embodiments, the catheter includes more than one needle. The catheter includes an outer sheath 412m and an inner catheter 402m. Positioning element 424m and needle 408m are positioned on inner catheter 402m, with needle 408m distal of positioning element 424 m. As shown in fig. 4M, catheter 400M is advanced into prostatic urethra 430M with needle 408M and positioning element 424M both in the collapsed configuration. Referring to fig. 4N, the positioning element 424N is expanded to hold the catheter 400N within the prostatic urethra 430N and the needle 408N is deployed into the prostatic tissue 428N to deliver the ablative agent. In various embodiments, the positioning element 424n has a funnel, bell, sphere, oval, or acorn shape when deployed, and is substantially cylindrical when compressed.

Fig. 4O is a flowchart illustrating steps involved in ablating a patient's prostate using an ablation catheter according to an embodiment of the present disclosure. At step 440, the condensing end of the catheter is used to push through the patient's prostatic urethra and position the distal end of the catheter against the patient's bladder. At step 442, the outer sheath of the catheter is retracted using the actuator to expose the positioning element or bladder anchor, and the positioning element is positioned, for example, in the bladder neck to position the catheter for ablation. At step 444, the outer sheath is further retracted to deploy the needle or needles from the catheter and into the prostate tissue. In some embodiments, one or more needles are deployed from the lumen of the inner catheter of the catheter and pass through slots in the outer sheath. In another embodiment, the sleeve folds naturally outward when the outer sheath is retracted. At step 446, steam or vapor is delivered through one or more needles to ablate the prostate tissue.

Fig. 5A illustrates prostate ablation performed on a swollen prostate in a male urinary system by using a catheter (e.g., catheter 400 of fig. 4A-with two positioning elements) according to an embodiment of the present disclosure. A cross-section of a male genitourinary tract with an enlarged prostate 502a, bladder 504a and urethra 506a is shown. The urethra 506a is compressed by enlarged prostate 502a. The ablation catheter 508a is passed through a cystoscope 510a in the urethra 506a distal to the obstruction. The positioning element 512a is deployed to center the catheter in the urethra 506a and one or more insulated needles 514a are passed through to pierce the prostate 502a. The steam ablator 516a passes through the insulated needle 514a causing ablation of diseased prostate tissue, resulting in prostate contraction. In one embodiment, only the proximal positioning element is used, while in another embodiment, only the distal positioning element is used.

The size of the enlarged prostate can be calculated by using the difference between the extra-prostatic urethra and the intra-prostatic urethra. Standard values can be used as baseline. Additional ports for infusion of cooling fluid into the urethra may be provided to prevent damage to the urethra when ablation energy is delivered to the prostate for ablation, thereby preventing complications such as stenosis formation.

In one embodiment, the positioning appendage must be separated from the ablation zone by a distance greater than 0.1mm, preferably 1mm to 5mm and not more than 2 cm. In another embodiment, the positioning accessory can be deployed in the bladder and pulled back into the urethral orifice/bladder neck, thereby securing the catheter. In one embodiment, the diameter of the positioning device is between 0.1mm and 10 cm.

Fig. 5B is a schematic diagram of transurethral prostate ablation performed on a swollen prostate 502B in a male urinary system using an ablation device (e.g., catheter 400 of fig. 4A-with one positioning element) in accordance with one embodiment of the present disclosure. Also depicted in fig. 5B are bladder 504B and prostatic urethra 506B. An ablation catheter 518b having a handle 520b and a positioning element 522b is inserted into the urethra 506b and advanced into the bladder 504 b. The positioning element 522b expands and is pulled to the junction of the bladder and urethra, thereby positioning the needle 514b at a predetermined distance from the junction. In some embodiments, the positioning element 522b expands to a first volume in the bladder 504b near the junction of the bladder 504b and the urethra 506b to position the needle 514b near the prostate 502 b; and a second volume different from the first volume to position the needle 514b at a different location near the prostate 504 b. Using a balloon as the positioning element 522b provides counter traction when the needle 514b is deployed.

The pusher 524b is used and then the needle 514b is pushed out of the catheter 518b through the urethra 506b into the prostate 504b at an angle between 10 degrees and 90 degrees. Steam is applied through port 526b, which travels through the shaft of catheter 518b and exits through opening 528b in needle 514b into the prostate tissue, thereby ablating the prostate tissue. In an embodiment, the steam is delivered for a predetermined time, reaches a predetermined pressure, and delivers a predetermined amount of energy. In some embodiments, the steam is delivered for a period of less than five minutes, and preferably for a period of time in the range between 2 seconds and 120 seconds, and more preferably for a period of time of 60 seconds to 90 seconds. In embodiments, the vapor is delivered at a pressure of less than 5atm, and in some cases less than 1atm, and preferably at a pressure of no more than 10% above atmospheric pressure. In an embodiment, the steam is delivered at an energy in the range of 10cal to 10000 cal.

In one embodiment, needle 514b is insulated to prevent damage to prostatic urethra 506b or periurethral areas. Additionally, in embodiments, the needle is deployed to deliver steam at a location preferentially remote from the ejaculatory duct. In some embodiments, the shape of needle 514b is different during delivery of the vapor than it was prior to delivery of the vapor.

An optional port 530b allows for insertion of a cooling fluid at a temperature <37 ℃ through opening 532b to cool the prostatic urethra 506b or periurethral region. An optional temperature sensor 534b may be installed to detect the temperature of the prostatic urethra and regulate the delivery of vapor.

Fig. 5C is a schematic illustration of transurethral prostate ablation performed on a enlarged prostate 502C in a male urinary system using an ablation device in accordance with another embodiment of the subject specification. Also depicted in fig. 5C are bladder 504C and prostatic urethra 506C. An ablation catheter 518c having a handle 520c and a positioning element 536c is inserted into the urethra 506c and advanced into the bladder 504 c. The positioning element 536c is a compressible disk that expands in the bladder 504c and is pulled to the junction of the bladder and urethra, positioning the needle 514c a predetermined distance from the junction. In some embodiments, the positioning element 536c is expanded to a first size in the bladder 504c near the junction of the bladder 504c and the urethra 506c to position the needle 514c near the prostate 502 c; and a second size different from the first size to position the needle 514c at a different location adjacent the prostate 502 c.

The pusher 524c is used and then the needle 514c is pushed out of the catheter 518c through the urethra 506c into the prostate 502c at an angle between 10 degrees and 90 degrees. Steam is applied through port 526c, which travels through the shaft of catheter 518c and exits through opening 528c in needle 514c into the prostate tissue, thereby ablating the prostate tissue. In an embodiment, the steam is delivered for a predetermined time to reach a predetermined pressure to deliver a predetermined amount of energy. In some embodiments, the steam is delivered for a period of less than five minutes, and preferably for a period of time in the range of 60 seconds to 90 seconds. In other embodiments, the steam is delivered for a period of time in the range of 2 seconds to 30 seconds. In another embodiment, the steam is delivered for a period of time in the range of 30 seconds to 60 seconds. In embodiments, the vapor is delivered at a pressure of less than 5atm, and in some cases less than 1atm, and preferably at a pressure of no more than 10% above atmospheric pressure.

In one embodiment, needle 514c is insulated to prevent damage to prostatic urethra 506c or periurethral areas. Additionally, in embodiments, the needle is deployed to deliver steam at a location preferentially remote from the ejaculatory duct. In some embodiments, the shape of needle 514c is different during vapor delivery compared to its shape prior to vapor delivery.

An optional port 530c allows insertion of a cooling fluid at a temperature <37 ℃ through opening 532c to cool the prostatic urethra 506c or periurethral region. An optional temperature sensor 534c may be installed to detect the temperature of the prostatic urethra and regulate the delivery of vapor.

Fig. 5D is a flowchart listing steps involved in transurethral enlargement of a prostate ablation procedure using an ablation catheter according to one embodiment of the present specification. At step 540d, an ablation catheter (e.g., catheter 400 of fig. 4A) is inserted into the urethra and advanced until its distal end is positioned in the bladder. The positioning element is then deployed over the distal end of the catheter and the proximal end of the catheter is pulled such that the positioning element abuts the junction of the bladder and urethra, thereby positioning the catheter shaft within the urethra at step 542 d. At step 544d, a pusher at the proximal end of the catheter is actuated to deploy the needle from the catheter shaft through the urethra and into the prostate tissue. At step 546d, an ablative agent is delivered through the needle and into the prostate to ablate the target prostate tissue.

Fig. 5E is a schematic diagram of performing transrectal prostate ablation on a swollen prostate in a male urinary system using an ablation device according to one embodiment of the present disclosure. Also depicted in fig. 5E are bladder 504E and prostatic urethra 506E. The ablation device includes a catheter 518e having a needle tip 538 e. An endoscope 552e is inserted into the rectum 554e for visualization of the enlarged prostate 502e. In various embodiments, the endoscope 552e is an ultrasound endoscope or transrectal ultrasound such that the endoscope may be visualized using radiographic techniques. A catheter 518e having a needle tip 538e is passed through the working channel of the endoscope and the needle tip 538e rectally enters the prostate 502e. A close-up view of the distal end of the catheter 518e (518G) and the needle tip 538e (538G) is depicted in FIG. 5G. The ablative agent is then delivered through needle tip 538e into the prostate tissue for ablation. In an embodiment, the prostate tissue is ablated without ablating the entire thickness of the rectal wall. In some embodiments, no more than 90% of the rectal wall thickness is ablated. In some embodiments, greater than 0% and less than 75% of a thickness of the rectal wall is ablated. In some embodiments, it is preferable to ablate a range of 1% to 25% of a thickness of the rectal wall and each increment therein. In some embodiments, the mucosal layer of the rectal wall is not ablated.

In one embodiment, the catheter 518e and the needle tip 538e are constructed of an insulating material. In various embodiments, the tip 538e is an echogenic or sonographic tip that can be observed using radiological techniques for accurate positioning in prostate tissue. In one embodiment, an optional catheter (not shown) may be placed in the urethra to insert fluid to cool the prostatic urethra 506e. In one embodiment, the inserted fluid has a temperature below 37 ℃.

Fig. 5F is a schematic diagram of performing transrectal prostate ablation on a swollen prostate in a male urinary system using a coaxial ablation device with a positioning element in accordance with another embodiment of the present disclosure. Also depicted in fig. 5F are bladder 504F and prostatic urethra 506F. The ablation device includes a coaxial catheter 518f, the coaxial catheter 518f having an inner catheter with a needle tip 538f and an outer catheter with a positioning element 522 f. An endoscope 552f is inserted into the rectum 554f for visualization of the enlarged prostate 502 f. In various embodiments, the endoscope 552f is an ultrasound endoscope or transrectal ultrasound such that the endoscope may be visualized using radiographic techniques. A coaxial catheter 518f having a needle tip 538f and a positioning element 522f is passed through the working channel of the endoscope such that the positioning element 522f rests against the rectal wall and the inner catheter is advanced rectally to position the needle tip 538f at a predetermined depth in the prostate 502 f. A close-up view of the distal end of the catheter 518f (518G) and the needle tip 538f (538G) is depicted in FIG. 5G. In one embodiment, the positioning element is a compressible disk having a first compressed pre-use configuration and a second expanded deployed configuration once it has passed beyond the distal end of endoscope 552 f. The ablative agent is then delivered through needle tip 538f into the prostate tissue for ablation. In an embodiment, the prostate tissue is ablated without ablating the entire thickness of the rectal wall. In some embodiments, no more than 90% of the rectal wall thickness is ablated. In some embodiments, greater than 0% and less than 75% of a thickness of the rectal wall is ablated. In some embodiments, it is preferable to ablate a range of 1% to 25% of a thickness of the rectal wall and each increment therein. In some embodiments, the mucosal layer of the rectal wall is not ablated.

In one embodiment, coaxial catheter 518f, needle tip 538f, and positioning element 522f are constructed of an insulating material. In various embodiments, the tip 538f is an echogenic or sonographic tip that can be observed using radiological techniques for accurate positioning in prostate tissue. In one embodiment, an optional catheter (not shown) may be placed in the urethra to insert fluid to cool the prostatic urethra 506f. In one embodiment, the inserted fluid has a temperature below 37 ℃.

Fig. 5H is a flowchart listing steps involved in a transrectal enlargement prostate ablation procedure using an ablation catheter, according to one embodiment of the present specification. At step 540h, an endoscope is inserted into the rectum of the patient for visualization of the prostate. Then, at step 542h, a catheter with a needle tip is advanced through the working channel of the endoscope and through the rectal wall and into the prostate. At step 544h, the needle is guided into the target prostate tissue using radiological methods. At step 546h, an ablative agent is delivered through the needle and into the prostate to ablate the target prostate tissue. In an embodiment, the prostate tissue is ablated without ablating the entire thickness of the rectal wall. In some embodiments, no more than 90% of the rectal wall thickness is ablated. In some embodiments, greater than 0% and less than 75% of a thickness of the rectal wall is ablated. In some embodiments, it is preferable to ablate a range of 1% to 25% of a thickness of the rectal wall and each increment therein. In some embodiments, the mucosal layer of the rectal wall is not ablated.

Fig. 6A shows an ablation catheter 600 according to an embodiment of the present disclosure, while fig. 6B is a cross-section of the tip of catheter 600. Referring now to fig. 6A and 6B, catheter 600 includes an elongate body 602 having a proximal end and a distal end. A plurality of openings 604 and an expandable balloon 606 are located near the distal end. The plurality of openings 604 enable a plurality of associated thermally conductive elements 608 (such as pins) to be extended (extending at an angle from catheter 600, with the angle ranging between 30 degrees and 90 degrees) or retracted through the plurality of openings 604. According to one aspect, the plurality of retractable needles 608 are hollow and include at least one opening to allow for delivery of an ablative agent, such as a vapor or steam 610, through the needles 608 as the needles are extended and deployed through the plurality of openings 604. A plurality of openings 604 extend from the body 602 and through the balloon 606 to enable the plurality of needles 608 to extend beyond the balloon 606 when deployed.

A heating chamber 612 is located at the proximal end of catheter 600. The heating compartment 612 includes a metal coil wound around a ferromagnetic core. The chamber 612 is filled with water via a water inlet port 614 at the proximal end of the chamber 612. An alternating current is supplied to the coil, creating a magnetic field that induces a current flow in the ferromagnetic core, thereby heating the chamber 612 and evaporating the water therein. The generated vapor or steam 610 exits the needle 608 to ablate the target tissue. Balloon 606 is inflated by filling balloon 606 with coolant, which is supplied to balloon 606 through coolant port 616 at the proximal end of chamber 612. During use, balloon 606 is inflated with coolant while vapor or steam 610 generated in chamber 612 is delivered through plurality of needles 608. As the needle 608 pierces the target tissue during use, the vapor or steam 610 delivered through the pierced needle 608 causes ablation of tissue deep in the target tissue. The coolant-filled dilation balloon 606 contacts the surface of the non-target tissue and maintains the ambient temperature on the surface of the non-target tissue at a desired level, for example below 60 ℃ in some embodiments. This enables the steam 610 to ablate deeper target tissue without circumferentially ablating non-target tissue at the surface. In some embodiments, the heating compartment 612 is located at the distal end of the catheter near the proximal-most needle 608 and the plurality of openings 604, and is configured to use RF energy to generate steam using resistive or ohmic heating of the saline. In all embodiments, the plurality of needles are electrically isolated from the heating chamber 612 by sections of the catheter 602 in order to prevent RF current from the electrodes from entering the tissue and entering the human body. In various embodiments, a conductive fluid, such as saline, is heated to a non-conductive ablative agent, such as steam, in order to minimize the chance of RF current from the heating chamber into the prostate tissue and patient's body. It is desirable to galvanically isolate the patient from RF so as not to interfere with any implanted electro-medical devices.

Fig. 6C is a schematic diagram of performing prostate ablation on a swollen prostate in a male urinary system using the ablation catheter 600 of fig. 6A, in accordance with an embodiment of the present disclosure. Also depicted in fig. 6C are a prostate 618 and a prostatic urethra 620. Referring now to fig. 6A and 6C, an ablation catheter 600 having a heating compartment 612 and an expandable cooling balloon 606 is inserted into the patient's urethra and advanced into the prostatic urethra 620 to position the plurality of openings 604 adjacent to the tissue to be ablated. The cooling balloon 606 is inflated by filling the cooling balloon 606 with coolant supplied from the coolant port 616 such that the inflated cooling balloon 606 abuts a surface of the prostatic urethra adjacent the prostatic tissue to be ablated. The pusher is used and then the needle 608 is pushed out of the catheter 600 into the prostate 618 at an angle (in various embodiments, ranging between 10 degrees and 90 degrees). Water is applied to the chamber 612 (through the water inlet port 614) and the water is converted to steam or vapor 610 in the chamber 612. The vapor or steam 610 travels through the body 602 of the catheter and exits through the opening in the needle 608 into the prostate tissue, thereby ablating the prostate tissue. In one embodiment, the needle 608 is insulated. The coolant-filled dilation balloon 606 maintains the ambient temperature on the surface of the prostatic urethral tissue at a desired level, for example below 60 ℃ in some embodiments. This enables the steam 610 to ablate deeper prostate tissue without circumferentially ablating prostatic urethral tissue at the surface. An optional temperature sensor may be installed to detect the temperature of the prostatic urethra and regulate the delivery of vapor. In some embodiments, the heating compartment 612 is located at the distal end of the catheter near the proximal-most needle 608 and the plurality of openings 604, and is configured to use RF energy to generate steam using resistive or ohmic heating of the saline. In an embodiment, the needle is separated from the RF electrode by an insulated section of the catheter to minimize or prevent RF current from entering patient tissue and preventing electrical interference with the electro-medical implant.

Fig. 6D is a flowchart listing steps involved in transurethral enlargement prostate ablation using the ablation catheter 600 of fig. 6A, in accordance with one embodiment of the present specification. Referring now to fig. 6A and 6D, at step 622, ablation catheter 600 is inserted into the urethra and advanced until the plurality of openings 604 are positioned within the prostatic urethra adjacent the prostatic tissue to be ablated. At step 624, the cooling balloon 606 is inflated with coolant supplied from the coolant port 616 to secure the catheter 600 within the prostatic urethra and maintain ambient temperature on the tissue surface to be ablated. At step 626, the pusher is used and then the needle 608 is pushed out of the catheter 600 at an angle (between 30 degrees and 90 degrees in various embodiments), through the prostatic urethra and into the prostate to a desired depth. Steam is delivered from the opening in the needle 608 to a desired depth in the prostatic tissue to ablate the prostatic tissue without ablating the surface of the prostatic urethra. An optional temperature sensor is used to monitor the temperature of the prostatic urethral surface and to control or regulate the flow of coolant to maintain the temperature of the prostatic urethral surface below, for example, 60 ℃.

Fig. 7A shows an ablation catheter 700 according to an embodiment of the present disclosure, while fig. 7B is a cross-section of the tip of the catheter 700. Referring now to fig. 7A and 7B, a catheter 700 includes an elongate body 702 having a proximal end and a distal end. A first plurality of openings 704, a second plurality of openings 706, and a silicone or teflon film 708 covering the first and second plurality of openings are located near the distal end. The first plurality of openings 704 enables a plurality of associated thermally conductive elements 710 (such as pins) to be extended (extending at an angle from the catheter 700, wherein the angle ranges between 30 degrees and 90 degrees) or retracted through the plurality of openings 704. The second plurality of openings 706 enables coolant 712 supplied via coolant ports 714 at the proximal end of the catheter 700 to be delivered to the ablation zone. According to one aspect, the plurality of retractable needles 710 are hollow and include at least one opening to allow for delivery of an ablative agent, such as vapor or steam 716, through the needles 710 as the needles are extended and deployed through the first plurality of openings 704. A plurality of openings 704 extend from the body 702 and through the balloon 708 to enable a plurality of needles 710 to extend beyond the membrane 708 when deployed. When deployed, the needle 710 pierces the membrane 708 such that the membrane 708 insulates the needle 710 when the needle 710 is deployed and pierced into the target tissue.

A heating chamber 718 is located at the proximal end of catheter 700. The heating compartment 718 includes a metallic coil wrapped around a ferromagnetic core. The chamber 718 is filled with water via a water inlet port 720 at the proximal end of the chamber 718. An alternating current is supplied to the coil, creating a magnetic field that induces a current flow in the ferromagnetic core, thereby heating the chamber 718 and evaporating the water therein. The resulting vapor or steam 716 exits the needle 710 to ablate the target tissue. A coolant port 714 at the proximal end of the chamber 718 supplies coolant 712 for delivery into the prostatic urethra through the plurality of second openings 706. During use, coolant 712 is delivered to the ablation region through coolant opening 706, while steam or vapor 716 generated in chamber 718 is delivered through the plurality of needles 710. In some embodiments, heating compartment 718 is located in the catheter body proximate to opening 704 and is configured to generate steam or vapor using RF resistive heating.

As the needle 710 pierces the target tissue during use, the vapor or steam 716 delivered through the pierced needle 710 causes ablation of tissue deep in the target tissue. The coolant 712 directly contacts the surface of the non-target urinary tract tissue and maintains the ambient temperature on the surface of the non-target tissue at a desired level, such as below 60 ℃ in some embodiments, thereby preventing or reducing clinically significant or circumferential thermal damage to the non-target tissue. This allows the steam 716 to ablate deeper prostate tissue without ablating urethral tissue circumferentially at the surface. In addition, the membrane 708 insulates the needle 710 and prevents the coolant 712 from significantly cooling the needle 710. In some embodiments, heating compartment 718 is located at the distal end of the catheter near proximal needle 710 and plurality of openings 704, and is configured to use RF energy to generate steam using resistive or ohmic heating of saline. The catheter is optimized to minimize any leakage of RF current into the tissue. In any event, the leakage is insufficient to produce clinically significant ablative lesions.

Fig. 7C is a schematic diagram of performing prostate ablation on a swollen prostate in a male urinary system using the ablation catheter 700 of fig. 7A, in accordance with an embodiment of the present disclosure. Also depicted in fig. 7C are a prostate 722 and a prostatic urethra 724. Referring now to fig. 7A and 7C, an ablation catheter 700 having a heating compartment 718 and an expandable cooling balloon 708 is inserted into the patient's urethra and advanced into the prostatic urethra 724 to position the first plurality of openings 704 and the second plurality of openings 706 adjacent to the prostatic tissue to be ablated. The coolant 712 is delivered to the prostatic urethra 724 through the plurality of second openings 706. The needle 710 is then pushed out of the catheter 700 into the prostate 722 at an angle (in various embodiments, ranging between 30 degrees and 90 degrees) using a pusher. The pushed needle 710 also perforates or traverses the insulating film 708 covering the opening 704.

Water or brine is applied to the chamber 718 (through a water inlet port 720), where the water or brine is converted to steam or vapor 716. The vapor or steam 716 travels through the body 702 of the catheter and exits through an opening in the needle 710 into the prostate tissue, thereby ablating the prostate tissue. When the needle 710 pierces the membrane 708, the needle 710 is insulated by the membrane 708. The coolant filled dilation balloon 708 and the coolant 712 delivered to the prostatic urethra 724 via the plurality of second openings 706 maintain the ambient temperature on the surface of the prostatic tissue at a desired level, such as below 60 ℃ in some embodiments, and preferably below 40 ℃ in other embodiments. This enables the steam 716 to ablate deeper prostate tissue without ablating prostatic urethral tissue at the surface in a clinically significant or circumferential manner. An optional temperature sensor may be installed to detect the temperature of the prostatic urethra and regulate the delivery of vapor 716 and/or coolant 712.

Fig. 7D is a flowchart listing steps involved in transurethral enlargement prostate ablation using the ablation catheter 700 of fig. 7A, in accordance with one embodiment of the present specification. Referring now to fig. 7A and 7D, at step 740, an ablation catheter 700 is inserted into the urethra and advanced until the first plurality of openings 704 are positioned within the prostatic urethra adjacent the prostatic tissue to be ablated. At step 742, the cooling balloon 708 is inflated with coolant supplied from the coolant port 714 to secure the catheter 700 within the prostatic urethra and maintain ambient temperature on the surface of the prostatic tissue to be ablated. At step 744, a pusher is used and then the needle 710 is pushed out of the catheter 700 at an angle (in various embodiments, between 10 and 90 degrees) to pierce the insulating film 708, through the prostatic urethra and into the prostate to a desired depth. Steam 716 is delivered from an opening in needle 710 to a desired depth in the prostate tissue to ablate the prostate tissue without ablating the surface of the prostate tissue. At step 746, coolant 712 is applied into the prostatic urethra via the plurality of second openings 706 to maintain ambient temperature on the surface of the prostatic tissue to be ablated. The membrane 708 isolates the needle 710 from the coolant 712 applied to the prostatic urethra. An optional temperature sensor is used to monitor the temperature of the surface of the prostate tissue and to control or regulate the flow of coolant to maintain the temperature of the surface of the prostate tissue below a specific temperature, which in some embodiments is 60 ℃.

Referring back to fig. 6A and 7A, according to some embodiments, a pump (e.g., a syringe pump or peristaltic pump) is used to control the flow of water to the heating compartments 612, 718.

In various embodiments, the catheter of the present specification further comprises at least one thermally conductive element attached to the positioning element. The at least one thermally conductive element is configured to physically contact and, in some embodiments, penetrate the target tissue and enhance delivery of thermal energy into the target tissue for ablation. Fig. 8A is an illustration of one embodiment of a positioning element 802 of an ablation catheter 800 depicting a plurality of thermally conductive elements 804 attached thereto. In various embodiments, positioning element 802 is an expandable balloon. The positioning element or balloon 802 is expanded to a first volume to bring the thermally conductive element 804 into contact with the target tissue. The ablative agent is then delivered through catheter 800 to the target tissue and out through at least one delivery port at the distal end of catheter 800. Thermal energy from the ablative agent is transferred from the lumen of catheter 800 into the air in balloon 802, further expanding the volume of balloon 802 and pushing thermally conductive element 804 further into the target tissue. Thermal energy from the air in the balloon 802 is transferred to the thermally conductive element 804 and released into the target tissue for ablation. In various embodiments, the thermally conductive element 804 comprises a solid or hollow metal pin or needle. In various embodiments, balloon 802 is constructed of an insulating material such that ablative heat energy is transferred primarily from thermally conductive element 804 into the target tissue.

Fig. 8B is an illustration of one embodiment of a positioning element 802 of an ablation catheter 800 depicting a plurality of hollow thermally conductive elements 806 attached thereto. In one embodiment, each hollow thermally conductive element 806 includes a valve 806 at an entrance from the lumen of the positioning element 802 to the lumen of the hollow thermally conductive element 806. In various embodiments, positioning element 802 is an expandable balloon. The positioning element or balloon 802 is expanded to a first volume to bring the thermally conductive element 804 into contact with the target tissue. The ablative agent is then delivered through catheter 800 to the target tissue and out through at least one delivery port at the distal end of catheter 800. Thermal energy from the ablative agent is transferred from the lumen of catheter 800 into the air in balloon 802, further expanding the volume of balloon 802 and pushing thermally conductive element 806 further into the target tissue. Thermal energy from the air in balloon 802 is transferred to thermally conductive element 806 and released into the target tissue for ablation. In various embodiments, the thermally conductive element 806 comprises a hollow metal pin or needle. The thermally conductive element 806 includes at least one opening at its distal end that is in fluid communication with the lumen of the thermally conductive element 806, which in turn is in fluid communication with the interior of the balloon 802. As seen in the cross-section of catheter 800, steam passes from the interior of balloon 802, through thermally conductive element 806, and out to the target tissue along first path 808. In one embodiment, each thermally conductive element 806 includes a valve 810 positioned at its junction with balloon 802 to control the flow of steam into each hollow thermally conductive element 806. In one embodiment, steam also enters the interior of balloon 802 along second path 812 to transfer thermal energy and assist in balloon inflation 802. In another embodiment, flexible tube 814 connects the lumen of each thermally conductive element 806 with the lumen of catheter 800, bypassing the interior of balloon 802. In one embodiment, tube 814 is constructed of silicone. In this embodiment, steam can only travel via the first path 808, and air 816 is used to inflate the balloon 802. In various embodiments, balloon 802 is constructed of an insulating material such that ablative heat energy is primarily transferred from thermally conductive element 806 into the target tissue. In various embodiments, thermally conductive elements 806 have shape memory properties such that they change shape from being substantially parallel to catheter 800 at temperatures below the patient's body temperature to being substantially perpendicular to catheter 800 at temperatures above the patient's body temperature.

Fig. 9 is a flow chart illustrating one embodiment of a method of ablating tissue using a catheter device as described above. The device includes a thermally insulated catheter having a hollow shaft and a retractable needle through which an ablative agent may travel, at least one infusion port on the needle for delivering the ablative agent, at least one positioning element on the distal end of the catheter, and a controller including a microprocessor for controlling the delivery of the ablative agent. Referring to fig. 9, in a first step 902, a catheter is inserted such that a positioning element is positioned adjacent to tissue to be ablated. The next step 904 involves extending the needle through the catheter such that the infusion port is positioned adjacent to the tissue. Finally, in step 906, an ablative agent is delivered through the infusion port to ablate tissue. In another embodiment, the device does not include a positioning element, and the method does not include the step of positioning the positioning element adjacent the tissue to be ablated.

In one embodiment, the needle catheter device depicted in fig. 8A and 8B is also used for steam ablation of submucosal tissue.

Fig. 10 is a flow chart illustrating a method of ablating submucosal tissue using a needle catheter device similar to those described above. Referring to fig. 10, in a first step 1002, an endoscope is inserted into a body cavity with its distal end adjacent to tissue to be ablated. Next, in step 1004, the submucosal space is pierced using a vapor delivery needle that is passed through the working channel of the endoscope by means of a catheter. Next, in step 1006, steam is delivered into the submucosa space to primarily ablate the submucosa and/or mucosa without irreversibly or significantly ablating the deep musculature or serosa. In one embodiment, in step 1008, the mucosa may optionally be resected with a snare or needle knife for histological evaluation. In some embodiments, saline injection, dextrose solution, glycerol Sodium Hyaluronate (SH), colloids, hydroxypropyl methylcellulose, fibrinogen solution, autologous blood or other agents known in the art (e.g., eleview ^TM ) Is used to pre-treat submucosa to produce submucosa elevation.

In another embodiment, the present specification discloses a shape changing needle for prostate tissue ablation. Fig. 11A is an exemplary illustration of a shape changing needle. Referring to fig. 11A, needle 1102a is made of a flexible material such as nitinol and has a curvature in the range of-30 to 120 °. In some embodiments, the needle tip is bent from 0 ° to 180 °. In one embodiment, as heat is applied to needle 1102a, its curvature increases, as shown at 1102 b. In one embodiment, the increase in curvature of the needle ranges from-30 ° to 120 ° for a temperature increase in the range of 25 ℃ to 75 ℃. According to one aspect, needle 1102a is hollow and includes at least one opening to allow for the delivery of an ablative agent, such as steam or vapor, through the needle. In some embodiments, a tension wire secured to the needle may be pulled to alter the shape of the needle or stabilize the needle to aid in penetration. In some embodiments, pulling these tension wires may help to perform a puncture or help to drive the needle deep into the prostate tissue.

Fig. 11B shows a different embodiment of a needle according to the present description. Referring to fig. 11B, needles 1102c, 1102d and 1102e are single needles of different curvatures. Needles 1102f and 1102g are double needles of different sizes. In some embodiments, needles 1102c, 1102d, 1102e, 1102f, and 1102g are covered in an outer insulating layer, described later in fig. 11K-11Q. Needles 1102f and 1102g illustrate exemplary embodiments of two needles extending from a single port. In some embodiments, the needle of fig. 11B is made of 22 gauge stainless steel. Fig. 11C illustrates an exemplary process of delivering an ablative agent 1104 from a hollow opening 1106 at the edge of a pair of needles 1108, 1110 of a double needle (e.g., double needle 1102f or 1102g of fig. 11B) according to some embodiments of the present description.

Fig. 11D illustrates exemplary depths or penetration depths of needles 1102c, 1102D, and 1102e of different curvatures according to some embodiments of the present description. The depth increases with increasing curvature. In some embodiments, needles 1102c, 1102d, and 1102e have a curvature that varies between 0 and 150 degrees, with a diameter of 15 to 30 gauge, and a length of each needle 1102c, 1102d, and 1102e ranging from 0.2 to 5 centimeters (cm). Fig. 11E illustrates exemplary depths or penetration depths of needles 1102f and 1102g relative to needles 1102c, 1102D and 1102E of fig. 11D according to some embodiments of the present description. Fig. 11F illustrates exemplary lengths of the needles 1102c, 1102d, 1102E, 1102F, and 1102g of fig. 11E extending in a straight line from the proximal port 1112 to the distal-most point 1114 reached by the needle body, according to some embodiments of the present description.

Fig. 11G illustrates different views of a single needle assembly 1116 extending from a port 1118, according to some embodiments of the present description. In an embodiment, port 1118 includes two cylindrical portions, a first portion 1118a and a second portion 1118b, wherein second portion 1118b is connected to an inner catheter (e.g., inner catheter 107M of fig. 1M) and first portion 1118a is attached to second portion 1118b, and a distal edge of first portion 1118a provides an outlet for one or more needles (e.g., needles 1116). In addition, fig. 11G shows top view 1116A, side view 1116B and front perspective view 1116C of needle 1116 in its default bent state. A side perspective view 1116D of needle 1116 is also shown in a linearly collapsed state. In one embodiment, the length of the needle 1116 extending in a straight line from the distal edge of the first portion 1118a to the furthest point of the needle 1116 is approximately 12mm, and the depth measured in a straight line from the sharp edge of the needle 1116 to the port is approximately 12.3mm. In some embodiments, first portion 1118a of port 1118 has a length of approximately 4.10mm and a diameter of approximately 2.35 mm. In some embodiments, second portion 1118b of port 1118 has a length of approximately 4.30mm and a diameter in the range of approximately 1.75 to 1.85 mm. Fig. 11H illustrates one or more holes 1120 at a sharp edge of a needle 1116 in another horizontal view of the needle 1116 according to some embodiments of the present disclosure. In some embodiments, each aperture 1120 for deploying ablation vapor extends a length of about 3.50mm on one side of the end of hollow cylindrical needle 1116. The aperture is positioned on one side along the length of the needle 1116, while the distal end of the needle 1116 is closed. In some embodiments, the distal tip may be closed with a plug 1122 made of a biocompatible material (e.g., stainless steel). In some embodiments, the distal tip is closed and steam exits from the sides of the distal tip.

Fig. 11I illustrates a different view of a dual needle assembly 1124 extending from a port 1126 according to some embodiments of the present description. Fig. 11J illustrates a different view of another dual needle assembly 1128 extending from a port 1132, according to some embodiments of the present description. Referring to fig. 11I and 11J together, the ports 1126, 1132 may include two cylindrical portions, a first portion 1126a, 1132a and a second portion 1126b, 1132b, wherein the second portion 1126b, 1132b is connected to an inner catheter (e.g., inner catheter 107M of fig. 1M), while the first portion 1126a, 1132a is attached to the second portion 1126b, 1132b, and the distal edge of the first portion 1126a, 1132a provides an outlet for the two-needle assembly 1124, 1128. The double needle assembly includes first needles 11241, 11281 and second needles 11242, 11282. Fig. 11I and 11J show top, side, and top perspective views 1124a, 1128a, 1124b, 1128b, 1124c, 1128c of needles 1124, 1128 in their default bent state. Side perspective views 1124d, 1128d of needles 1124, 1128 are also shown in a linearly collapsed state. Referring to fig. 11I, the length of the needle 11241 extending in a straight line from the distal edge of the port 1126 to the furthest point of the needle 11241 is about 17mm, and the depth from the sharp edge of the needle 11241 to the port 1126 measured in a straight line is about 13.4mm. The length of the needle 11242 extending in a straight line from the distal edge of the port 1126 to the furthest point of the needle 11242 is about 12mm and the length measured in a straight line from the sharp edge of the needle 11242 to the port 1126 is about 12.2mm. In an embodiment, port 1126 is configured similar to port 3808. The distance between the sharp edges of the needles 11241 and 11242 is about 5mm. Referring to fig. 11J, needle 11281 has a length extending in a straight line from the distal edge of port 1132 to the furthest point of needle 11281 of about 22mm and a length measured in a straight line from the sharp edge of needle 11281 to port 1132 of about 13.4mm. The length of needle 11282 extending in a straight line from the distal edge of port 1132 to the most distal point of needle 11282 is about 12mm and the length measured in a straight line from the sharp edge of the needle to port 1132 is about 12.2mm. In an embodiment, port 1132 is configured similar to port 3808. The distance between the sharp edges of needles 11281 and 11282 is about 10mm. In some embodiments, one or both of needles 11281 and 11282 have one or more openings or holes 1130 on the sides along their length, while the distal ends of one or both of needles 11281 and 11282 with holes 1130 are closed by plugs 1134. The holes 1130 provide outlets for the ablative vapor.

Fig. 11K shows insulator 1136 on a single needle configuration 1138 including needle 1140 and a double needle configuration 1142 including needles 1144 and 1146. Each of the needles 1140, 1144, and 1146 may have one or more openings, such as opening 1148 at the end of the needle 1140, to enable venting of steam during ablation. Insulator 1136 insulates a portion of the outer length of pins 1140, 1144, and 1146. In some embodiments, the insulator 1136 may be added as a shrink tube or as a spray. In various embodiments, the insulator 1136 extends along any portion of the length of the needles 1140, 1144, and 1146 from their distal tips to their bases, but does not cover any openings at the distal tips or along the length of the needles. The ablation region may be modified by changing the distribution of the insulator 1136 over the needle. This is shown with reference to fig. 11L, 11M, and 11N.

Fig. 11L illustrates a single needle configuration 1140 with an insulator 1136 positioned within a prostate tissue 1150 according to some embodiments of the present disclosure. The insulator 1136 covers a portion of the length of the needle 1140 before it extends from the catheter 1156 to the end of the needle 1140 such that a portion of the insulator 1136 extends from the urethra 1152 into the prostatic tissue, thus protecting the urethra 1152. Fig. 11M illustrates a single needle configuration 1140 in which an insulator 1136 is located within a uterine fibroid 1158, in accordance with some embodiments of the present disclosure. Needle 1140 extends from uterus 1160 into fibroids 1158. With respect to the range shown in fig. 11L, the insulator 1136 covers a greater extent of the needle 1140 such that the insulator 1136 extends into the fibroid 1158 with a small portion of the tip of the needle 1140 and delivers only ablation vapor to the fibroid 1158 while protecting portions of the anatomy outside of the fibroid. Fig. 11N illustrates a two-needle configuration 1142 in which two needles 1144 and 1146 are inserted into separate prostate lobes 1162 and 1164, according to some embodiments of the present description. An insulator 1136 covering both needles 1144 and 1146 extends into lobes 1162 and 1164 along with the uninsulated distal tip of the needle.

Fig. 11O illustrates an exemplary embodiment of a steerable catheter shaft 1166 according to some embodiments of the present disclosure. The catheter shaft 1166 is configured to be flexible such that it may be manipulated by a user to guide the needle 1140 in a desired direction. Referring to the drawings, arrow 1168 represents the ability to maneuver the needle in different directions using the catheter shaft 1166. In an embodiment, a viewing device 1170 is configured at the end of the catheter shaft 1166 at the base of the needle 1140 to aid in the direct visualization of the articulating needle 1140 by a user. In an embodiment, viewing device 1170 includes a camera, lens, LED, or any other device to facilitate direct visualization of the position and movement of needle 1140 within the patient's anatomy to aid a physician in manipulating needle 1140. In an embodiment, a channel 1172 in the catheter shaft 1166 provides optics and wires for receiving a viewing device 1170 connected to a controller (e.g., controller 15 q) for powering and for displaying captured images on a screen or split screen to view the ablation region and control ablation delivery. In some other embodiments, the viewing device 1170 interfaces with a peripheral computing and/or imaging device (e.g., an iPhone) to display images captured by its camera. In an embodiment, the controls of the viewing device 1170 are disposed in the handle of the catheter shaft 1166. In one embodiment, the needle is manipulated using a plurality of tension wires attached to the needle, and pulling those tension wires allows the position or direction of the needle tip to be manipulated.

Fig. 11P illustrates a needle 1140 having an open end 1174 according to some embodiments of the present disclosure. The figure also shows vapor 1176 ejected from an opening at distal tip 1174. In practice, before the ablation vapor or steam 1176 is injected, the needle 1140 is first rinsed with water to expel any air. Fig. 11Q shows an alternative embodiment of needle 1140 according to the present description having a stopper 1178 at its distal end to close the end and including a hole or opening 1180 near the end along the uninsulated length of needle 1140 to provide a spray of vapor 1176.

Fig. 12 is a schematic illustration of transurethral prostate ablation performed on a enlarged prostate 1202 in a male urinary system using an ablation device utilizing a shape-changing needle, according to one embodiment of the present disclosure. Also depicted in fig. 12 are bladder 1204 and prostatic urethra 1206. An ablation catheter 1208 having a handle 1210 and a positioning element 1212 is inserted into the urethra 1206 and advanced into the bladder 1204. In one embodiment, the positioning element 1212 is inflated and pulled to the junction of the bladder and urethra, thereby positioning the needle 1214a at a predetermined distance from the junction. The needle 1214a is then pushed out of the catheter 1208 through the urethra 1206 into the prostate 1202 at an angle between 10 degrees and 90 degrees using a pusher (not shown) coupled to the handle 1210. Steam is applied through a port (not shown) that travels through the shaft of the catheter 1208 and exits through the opening 1216 in the needle 1214a into the prostate tissue, thereby ablating the prostate tissue. According to one embodiment, the vapor delivery heats the needle, and as the vapor is delivered, the shape of the needle changes from a substantially straight 1214a to a curved 1214b. When the delivery of steam ceases, the needle returns to its original rectilinear shape, which allows easy retraction into the catheter. The mechanical shape change of the needle allows a more efficient distribution of ablation energy within the prostate tissue. In an embodiment, inductive heating or resistive heating is used to generate steam in the handle 1210 or body 1208 of the catheter.

Fig. 13A is an illustration of one embodiment of a positioning element 1302 of an ablation catheter 1304 with a needle 1306 attached to the catheter body. In various embodiments, the positioning element 1302 is an expandable balloon. The positioning element or balloon 1302 expands to a first volume, positioning the needle 1306 at a predetermined distance from the bladder neck 1308 and bringing them into contact with the target tissue. In one embodiment, an ablative agent (e.g., steam or vapor) is delivered to target tissue through catheter 1304. Traveling through the shaft 1310 of the catheter, the vapor exits from an opening (not shown) in the needle 1306 into the prostate tissue, thereby ablating the prostate tissue. In one embodiment, balloon 1302 can be expanded to different sizes. In one embodiment, this feature is used to gradually or sequentially expand the balloon 1302 to different sizes, positioning the needle at various fixed distances 1312, 1314 from the bladder neck 1308, allowing for treatment of discrete regions of prostate tissue. In one embodiment, the predetermined distance that the balloon may use to place the needle is in the range of 1mm to 50mm from the bladder neck. In one embodiment, the positioning element 1302 may be movable relative to the needle 1306 to adjust the needle range from 1mm to 50mm from the positioning element 1306. In another embodiment, the positioning element 1302 may engage a length of needle 1306 to apply a mechanical force that assists the needle in penetrating the target tissue.

In another embodiment shown in fig. 13B, a plurality of inflatable balloons 1316, 1318, 1320 are used as positioning elements. These balloons may be used to position the needle 1322 at various fixed distances 1324, 1326 from the bladder neck 1328, allowing for treatment of discrete regions of prostate tissue. It may be noted that any one of the plurality of balloons may be expanded depending on the tissue region to be ablated. The balloon may also be ablated in a sequential manner to allow full coverage of the target tissue. In one embodiment, the number of balloons ranges from one to five.

Fig. 13C shows a cross section of the distal tip of catheter 1330 according to an embodiment of the present disclosure. In one embodiment, for ablating prostate tissue, the Inner Diameter (ID) of the catheter used is about 4mm and the Outer Diameter (OD) is about 6mm. A plurality of thermally conductive elements 1332, such as pins, extend from catheter 1330 at an angle, wherein the angle ranges between 30 degrees and 90 degrees. In one embodiment, the needle may be retracted into the catheter after ablation.

In one embodiment, the balloon is inflated prior to ablation. In another embodiment, the ablative agent (e.g., steam or vapor) also transfers thermal energy and facilitates balloon expansion. That is, thermal energy from the ablative agent is transferred from the lumen of the catheter into the air in the balloon, further expanding the volume of the balloon and pushing the needle further into the target tissue. In yet another embodiment, the balloon is inflated by filling the balloon with a coolant, which is supplied to the balloon through a coolant port at the proximal end of the catheter. During use, the balloon is inflated with a coolant while steam or vapor is delivered through the plurality of needles. As the needle pierces the target tissue during use, the vapor or steam delivered through the pierced needle causes ablation of tissue located deep in the target tissue. The coolant-filled dilation balloon contacts the surface of the target tissue and maintains the ambient temperature on the target tissue surface at a desired level, for example below 60 ℃ in some embodiments. This enables the steam to ablate deeper tissue without ablating tissue at the surface.

Fig. 14 illustrates one embodiment of a handle mechanism 1400 that can be used to deploy and retract a needle at variable insertion depths when ablating prostate tissue. Referring to fig. 14, in one embodiment, the handle 1400 is shaped like a hand-held gun or pistol, which allows the physician to conveniently manipulate the handle 1400 to treat prostate tissue. The distal end 1402 of the handle is provided with a slot into which the ablation catheter 1404 can be inserted to access the patient's urethra. The ablation needle is coupled to the catheter as explained in the embodiments above and is used to deliver the vapor to the target tissue. A marker 1406 is placed on top of the handle 1400 indicating the depth of insertion of the needle. The indicia may be placed by printing, etching, painting, engraving, or by using any other means known in the art to be suitable for the purpose. In one embodiment, the ablation needle may be inserted or retracted in fixed distance (e.g., 5 mm) increments, and the markers are accordingly placed to reflect the increments. A button 1408 is provided on the marker, the button 1408 being advanced or retracted by the marker each time the catheter and needle are advanced or retracted a preset distance. In one embodiment, the trigger 1410 is provided on a handle mechanism and the trigger 1410 may be pressed to advance the needle a preset distance increment. In one embodiment, once the needle is advanced to the maximum distance by repeatedly pressing the trigger, as shown by button 1408 on the label, further pressing the trigger causes retraction of the needle one distance increment at a time. It may be noted that as explained in the above embodiments, the catheter is also provided with a positioning element, e.g. a balloon, which does not allow the catheter and needle to advance beyond a fixed distance in the urethra.

In one embodiment, a knob or button 1412 is provided that can be rotated or pressed to control the direction of movement of the catheter and needle. That is, knob 1412 may be used to determine whether the catheter and needle are moving forward (advancing) or backward (retracting) each time trigger 1410 is pressed.

In one embodiment, the handle mechanism 1400 further includes a heating chamber 1414, the heating chamber 1414 being for generating steam or vapor for supply to the conduit 1404. The heating cells 1414 include a metal coil 14165 wrapped around a ferromagnetic core. The chamber is filled with water via a water inlet port 1418 located at the proximal end of the handle mechanism 1400. In one embodiment, sterile water is supplied from a water source into the handle for conversion to steam. The handle is also equipped with electrical connections 1420 to supply current from a current generator to the coil 1416. Alternating current is supplied to the coil 1416, thereby generating a magnetic field that induces a current flow in the ferromagnetic core. This causes heating in the chamber 1414 and causes water therein to evaporate. The resulting vapor or steam generated in the chamber 1414 is delivered through a needle placed in position to ablate the target tissue.

In one embodiment, a start/stop button 1422 is also provided on the handle 1400 to start or stop ablation therapy as desired.

The same function may be achieved by other handle form factors known in the art and also described in this application.

Fig. 15A is a flowchart showing a method of prostate tissue ablation according to one embodiment of the present disclosure. Referring to fig. 15A, a first step 1502a includes accessing a catheter of an ablation device into a urethra of a patient, wherein the catheter includes a hollow shaft through which an ablative agent may travel, at least one first positioning element, at least one second positioning element distal to the at least one first positioning element, at least one input port for receiving the ablative agent, and a plurality of needles on the catheter between the first and second positioning elements and configured to deliver the ablative agent to prostate tissue. In one embodiment, the ablation device includes a controller including a microprocessor for controlling delivery of the ablative agent. The catheter is passed through the urethra such that the first positioning element is positioned proximal to the prostate tissue to be ablated and the second positioning element is positioned in or distal to the prostate tissue to be ablated. Next, in step 1504a, the positioning elements are deployed such that they contact the urethra and the catheter is positioned within the urethra adjacent the prostate tissue to be ablated. In a next step 1506a, a plurality of needles are passed through the urethra into the prostate tissue to be ablated. Finally, in step 1508a, an ablative agent is delivered through the needle to ablate the prostate tissue. Optionally, a sensor is used to measure a parameter of the prostate in step 1510a and this measurement is used to increase or decrease the flow of the ablative agent being delivered in step 1512 a. Alternatively, in one embodiment, the cystoscope is first inserted into the patient's urethra and the catheter is inserted through the cystoscope. In some embodiments, one or more positioning elements are inflated with an insulating or cooling fluid to insulate or cool the bladder neck or prostatic urethra.

Fig. 15B is a flowchart showing a method of prostate tissue ablation according to another embodiment of the present disclosure. Referring to fig. 15B, a first step 1502B includes accessing a catheter into a urethra of a patient, wherein the catheter includes a hollow shaft through which an ablative agent may travel, at least one first positioning element, at least one second positioning element distal to the at least one first positioning element, at least one input port for receiving an ablative agent, and a plurality of needles positioned on the catheter between the first and second positioning elements and configured to deliver an ablative agent to prostate tissue. In one embodiment, the ablation device includes a controller including a microprocessor for controlling delivery of the ablative agent. The catheter is passed through the urethra such that the first positioning element is positioned adjacent the prostate tissue to be ablated and the second positioning element is positioned within the bladder of the patient. Next, in step 1504b, the second positioning element is deployed and the catheter is pulled back so that the second positioning element abuts the urethral meatus at the bladder neck. At 1506b, the first positioning element is deployed such that the catheter is positioned within the urethra adjacent the prostate tissue to be ablated. In a next step 1508b, a plurality of needles are passed through the urethra into the prostate tissue to be ablated. Finally, in step 1510b, an ablative agent is delivered through the needle to ablate the prostate tissue. Alternatively, in one embodiment, the cystoscope is first inserted into the patient's urethra and the catheter is inserted through the cystoscope. In various embodiments, the order of deployment of the positioning elements may be reversed. In other embodiments, only one of the two positioning elements may be deployed to deliver the treatment.

Fig. 15C-15E illustrate an embodiment of expanding/widening a contracted prostatic urethra 1538 using expandable catheter 1500 according to some embodiments of the present description. The prostatic urethra 1538 has been contracted by the enlarged prostate 1530. Referring to fig. 15C, a compression catheter 1500 with an expandable element 1525 is advanced into the prostatic urethra 1538. In an embodiment, the expandable element 1525 comprises an expandable balloon or a self-expanding balloon. In an embodiment, the expandable element 1525 is covered, for example, by a semi-permeable sheath. In other embodiments, the expandable element 1525 is uncovered. In an embodiment, expandable catheter 1500 includes a central column 1537. The center post includes one or more rows 1533, each row including a plurality of openings for delivering ablative agents. In an embodiment, each of the plurality of openings has a pattern of openings that can vary in shape, diameter, and number of openings to adjust ablative agent distribution. Referring to fig. 15D, the expandable element 1525 on the catheter 1500 expands and presses against the urethral wall 1539, the urethral wall 1539 pressing against the prostate 1530. Ablative agent 1541 (e.g., vapor) is then delivered from the plurality of openings into the prostate tissue. Referring to fig. 15E, catheter 1500 is removed from urethra 1538, leaving widened prostatic urethra 1538. Fig. 15F illustrates an exemplary use of an expanded expandable element 1525 of catheter 1500, and one or more needles 1550 to allow for the delivery of an ablative agent 1541, such as steam or vapor, through a hollow outlet at the edge of needle 1550. The needle extends from the central column 1537 of the catheter 1500, through the urethral wall 1539 and into the prostate 1530 to deliver the ablative agent 1541 to the prostate tissue. Although the illustration of fig. 15F depicts placement of element 1525 into the prostate, the same arrangement may be used for both BPH and urethral stricture. In an embodiment, needle 1550 is one or more of the needles shown and described in the context of fig. 11A-11J. In some embodiments, the expandable element 1525 is a wire mesh stent that can be removed at a later date. In another embodiment, the expandable element 1525 is made of a bioresorbable material and resorbs after a predetermined time. In some embodiments, the expandable element 1525 has a constraining and/or removing mechanism attached thereto for removal at a later date. In some embodiments, the constraining and/or removing mechanism is PTFE, ePTFE, or silk suture. In some embodiments, the expandable element includes an extracellular matrix to aid in proper healing of the prostatic urethra after ablation.

Middle lobe hyperplasia is a benign condition in which the middle lobe of the prostate becomes enlarged and presses into the base of the bladder, causing a ball valve type obstruction at the bladder neck. For ablative treatment, it is desirable to enter the middle lobe, particularly the most affected portion of the middle lobe, via a cyst rather than via the urethra. The passage of the bladder into the middle lobe of the prostate, rather than the urethra, has the advantage of not causing ablative damage to the urethra and subsequent urethral stricture. Fig. 15G illustrates an ablation catheter 1560 for ablating prostate tissue of a patient with middle lobe hyperplasia by a transcapsular approach according to one embodiment of the present disclosure. Fig. 15H illustrates an ablation catheter for ablating prostate tissue of a patient with middle lobe hyperplasia by a transcapsular approach according to another embodiment of the present disclosure. In the embodiment of fig. 15G, catheter 1560 includes at least one curved vapor delivery needle 1561 extending at a distal end thereof. In the embodiment of fig. 15H, catheter 1565 includes at least one straight vapor delivery needle 1566 extending at a distal end thereof. The one or more needles and their composition and method of deployment may be similar to other needle embodiments discussed in the embodiments of the present specification. Referring simultaneously to fig. 15G and 15H, catheters 1560, 1565 are depicted as being inserted into and through the patient's spongy or penile urethra 1571, through the prostatic urethra 1572, and into the patient's bladder 1573. In an embodiment, the distal ends of the catheters 1560, 1565 are advanced to be positioned just beyond the bladder neck 1574 and within the bladder 1573 just into the bladder 1573 through the internal urethral orifice 1576 (the opening of the bladder into the prostatic urethra). At least one needle 1561, 1566 extends from the distal end of the catheter 1560, 1565 into the cavity of the bladder 1573, through the bladder wall 1577 into the medial leaf 1575. An ablative agent in vapor or steam form is delivered through at least one needle 1561, 1566 to ablate tissue of the middle lobe 1575. In some embodiments, the catheters 1560, 1565 optionally include at least one positioning element 1562, 1564 configured to position the catheters within the bladder 1573 and stabilize the needles 1561, 1566 to help the needles 1561, 1566 penetrate the middle lobe 1575. In various embodiments, the positioning elements 1562, 1564 comprise a shape memory material that is configurable between a first collapsed configuration for delivery and a second expanded configuration for positioning. In various embodiments, in the second expanded configuration, the positioning elements 1562, 1564 have a disk shape, a cone shape, a cap shape, an oval shape, an egg shape, a square shape, a rectangle shape, or a flower shape. In various embodiments, a tension wire attached to the needle may be used to manipulate the needle and assist in penetration into the prostate.

Fig. 15I is a flowchart listing steps in one method of ablating prostate tissue of a patient with middle lobe hyperplasia via an transcapsular approach using an ablation catheter, according to one embodiment of the present disclosure. At step 1580, an ablation catheter including at least one needle is advanced into the patient's spongy urethra and through the prostatic urethra such that the distal end of the catheter is positioned within the patient's bladder. Optionally, the ablation catheter further comprises at least one positioning element configured to position the catheter in the bladder and stabilize the at least one needle for penetration of the medial leaflet. Optionally, at step 1581, a positioning element is deployed to position the catheter and stabilize the at least one needle. At step 1582, at least one needle extends from the distal end of the catheter and through the bladder or bladder neck wall and into the medial lobe of the prostate. At step 1583, an ablative agent is delivered through at least one needle into the middle lobe to ablate the prostate tissue. In an embodiment, the ablation catheter is part of an ablation system comprising a controller and means for generating an ablative agent. In step 1584, the controller controls the delivery of the ablative agent to maintain the pressure in the bladder and middle lobe below 5 atm.

In various embodiments, the ablation therapy provided by the steam ablation system of the present specification is delivered to achieve the following treatment endpoints of prostate ablation: maintaining the tissue temperature at 100 ℃ or less; at 6 months follow-up after treatment, patient urine flow improves by at least 5% relative to pre-treatment urine flow; at 6 months follow-up after treatment, the volume of the prostate is reduced by at least 5% relative to the volume of the prostate treated; at six months follow-up, post-urination residue was reduced by greater than 5%; the incidence rate of acute urinary retention is reduced by 5% at the 12-month follow-up; prostate specific antigen was reduced by 5% at 6 months follow-up; at 6 months follow-up, the american urinary association symptom index improved by more than 5%; ablating the prostate tissue without circumferentially ablating urethral tissue; an improvement in International Prostate Symptom Score (IPSS) over pre-treatment IPSS scores of at least 5%, wherein the IPSS questionnaire depicted in fig. 16A includes a series of questions 1602 about the patient's urinary habits, each question having a numerical score 1604; improving Benign Prostatic Hypertrophy Impact Index Questionnaire (BPHIIQ) scores by at least 10% relative to pre-treatment BPHIIQ scores, wherein the BPHIIQ depicted in fig. 16B comprises a series of questions 1606 about patient urinary questions, each question having a numerical score 1608; and patient reports greater than 25% satisfaction with the ablation procedure.

Endometrial resection

Fig. 17A shows a typical anatomy 1700 of a uterus 1706 and fallopian tube of a human female. Fig. 17B shows the location of the uterus and surrounding anatomy 1700 within a female body. Fig. 18A illustrates an exemplary ablation catheter 1802 arrangement for ablating a uterus 1706, according to some embodiments of the present description. Referring also to fig. 17A and 18A, in an embodiment, a coaxial catheter 1802 is used to be inserted into a patient's vagina 1702 and advanced toward cervix 1704. The catheter 1802 includes an outer catheter 1804 and an inner catheter 1806. The inner conduit 1806 is concentric with the outer conduit 1804 and has a smaller radius than the outer conduit 1804. An electrode 1808 for heating the catheter tip is positioned between the two positioning elements 1810, 1812. In some embodiments, the electrode 1808 is proximal to the proximally located element 1810. In some embodiments, the positioning element is a disk-a proximal disk 1810 and a distal disk 1812. For purposes of this description, the discs 1810 and 1812 may also be referred to as shields 1810 and 1812. In some embodiments, the distal cap 1812 has a smaller diameter than the proximal cap 1810. In some embodiments, the distal shroud 1812 is about 5mm smaller than the proximal shroud 1810. In an embodiment, the shields 1810 and 1812 are made of wires having different wire stiffness. The distal cap 1812 is configured to contact the bottom of the uterus 1706 and act as a scaffold to push the halves of the uterus away from each other. Proximal cap 1810 is configured to close internal cervical opening 1708.

Fig. 19A, 19B, and 19C illustrate different types of configurations 1901, 1903, 1905 of distal and proximal discs 1812, 1810, which may be used in accordance with embodiments of the present description. The stiffness and size of the disc may be different and may be selected by the physician based on the treatment instructions. In some embodiments, the disk is conical in shape, varying from 5mm to 50mm in diameter. In some embodiments, the positioning element is an oval cone, wherein a first proximal diameter of the cone is smaller than a second distal diameter of the cone to approximate the shape or size of the uterine cavity. In various embodiments, the first positioning element may have a different shape or size than the second positioning element. One or more positioning elements may be used for therapeutic purposes.

In some embodiments, the disks 1812, 1810 are formed from wires made from one or a combination of polymers and metals, including, for example, but not limited to, polyetheretherketone (PEEK) and nickel titanium (NiTi). In some embodiments, the wires are covered with an elastomer, such as PU and/or silicone, in various patterns. The various units in the trays 1812, 1810 may be covered or uncovered based on the hood function (such as whether it is used for sealing, or for ventilation, or for any other purpose). In embodiments where the positioning elements 1812, 1810 are made of nitinol wire mesh, the wire diameter is in the range of 0.16 to 0.18 mm. In some embodiments, for the distal positioning element 1812, the wire mesh is coated with silicone, rather than the areas between wires in the mesh, thus allowing vapor to escape/escape from these spaces between the wires. In some embodiments, for the proximal positioning element 1810, the wire and the space between the wires are covered with silicone.

In an embodiment, the inner catheter 1806 may be moved into and out of the outer catheter 1804 such that the outer catheter 1804 covers the inner catheter 1806 and constrains the positioning elements 1810, 1812 prior to insertion into the uterus of a patient. The positioning elements 1810, 1812 are constructed of a shape memory material such that once the inner catheter 1806 extends beyond the distal end of the outer catheter 1804, they expand into a deployed configuration, as shown in fig. 18A.

In an embodiment, the inner catheter 1806 is disposed within the outer catheter 1804 and the catheter 1802 with the positioning elements 1810, 1812 in the first constrained configuration is inserted into the vagina 1702 such that the distal end of the outer catheter 1804 is positioned adjacent the inner port 1708. The inner catheter is then advanced into the uterus 1706. The catheter 1802 is advanced until the distal disc 1812 is within the uterus 1706 and the proximal disc 1810 closes the uterus 1706 by positioning it adjacent the inner port 1708. In an embodiment, the catheter 1802 includes a collar 1803 that is attached to the outer catheter 1804. When the catheter 1802 is deployed in the patient's uterus, the collar 1803 abuts the outer port and helps to hold the catheter 1802 in the correct position. When the catheter 1802 is deployed, the distal portion 1804c of the outer catheter 1804 is positioned within the cervix or cervical canal, the distal portion 1804c extending from the collar 1803 to a proximal point of the proximal positioning element 1810. In an embodiment, the distal positioning element 1812 and the proximal positioning element 1810 move independently, or expand and lock together. In an embodiment, the insertion length of the inner catheter 1806 is used to measure the uterine depth and determine the amount of steam ablation to be used in order to maintain the pressure within the uterus 1706 below a predetermined threshold. A steam port 1814 is located on the inner conduit 1806 between the distal disk 1812 and the proximal disk 1810 to output steam for ablation. The plurality of steam ports are positioned in a circumferential pattern around the length of the conduit. The size, shape, or port density (number of ports/length of conduit) of the vapor ports can be varied to optimize vapor delivery into the uterine cavity. Steam 1809 heats the endometrium adjacent to distal disc 1812 and then travels in a direction toward proximal disc 1810 while pushing out the endometrial air. In another embodiment, the vapor delivery port is configured to heat the entire endometrial cavity simultaneously and uniformly. In an embodiment, at least one of the inner 1806 or outer 1804 catheters includes a venting element or groove 1816 that allows the uterus 1706 to vent to allow endometrial air to escape and prevent overpressure of the endometrial cavity. In some embodiments, the grooves may be present around a percentage of the total circumference of the inner conduit 1806 or the outer conduit 1804. In some embodiments, the grooves are present around the total circumference of the inner conduit 1806 or the outer conduit 1804, and more preferably about 1% to 90% of the total circumference of the inner conduit 1806 or the outer conduit 1804. Fig. 18B illustrates an exemplary embodiment of a recess 1816 configured in the wall of an inner conduit 1806 according to some embodiments of the present description. In some embodiments, the opening in the proximal disc 1810 allows ventilation of the uterus 1706. In an embodiment, the proximal disc 1810 is covered in an elastomer (such as PU or silicone) in a pattern with various cells or openings in the disc 1810 that are uncovered and allow venting during ablation. In other embodiments, where sealing is required, there are no uncovered cells or openings in the tray 1810 to allow ventilation. In an embodiment, a pressure sensor 1822 is used with the catheter 1802 to check and then maintain the pressure within the uterus 1706 below 50mmHg, preferably below 30 mmHg, more preferably below 15 mmHg. In embodiments, the pressure is also maintained at no more than 10% above atmospheric pressure. Because of the low pressure level maintained in the uterus, embodiments of the present specification are able to forgo integrity checks that would otherwise be time consuming and involve risks and are required in prior art implementations. In one embodiment, the endometrial cavity pressure is measured by the generator by measuring the back pressure on saline pushed through the inner catheter to the electrode, and can be adjusted by adjusting the saline flow to maintain the endometrial cavity pressure at less than 5atm. In some embodiments, the endometrial cavity pressure is maintained at less than 0.5atm.

Fig. 18C is a flowchart of one method of ablating endometrial tissue using the catheter of fig. 18A, according to some embodiments of the present disclosure. At step 1830, a catheter is inserted into the uterus of the patient. At step 1832, a contact or partial seal is created between the outer surface of the device and the uterine wall. Then, at step 1834, steam is delivered through the catheter into the uterus of the patient. At step 1836, the vapor condenses on the tissue of the uterus, wherein the partial seal is a temperature-dependent seal and breaks once the temperature within the sealed portion of the uterus exceeds >90 ℃, and wherein the partial seal is a pressure-dependent seal and breaks once the pressure within the sealed portion of the uterus exceeds 1.5psi, preferably 1.0psi, and more preferably 0.5 psi. In another embodiment, the partial seal ruptures once the pressure within the sealed portion of the uterus exceeds 2psi or 10mm Hg. In another embodiment, the partial seal ruptures when the pressure exceeds 6psi or 30mm Hg. In some embodiments, the partial seal is a pressure-dependent seal and breaks once the temperature within the sealed portion of the uterus exceeds 101 ℃ and the pressure exceeds 0.5 psi. In some embodiments, the partial seal is a pressure-dependent seal and breaks once the temperature within the sealed portion of the uterus exceeds 102 ℃ and the pressure exceeds 1.0 psi. In some embodiments, the partial seal is a pressure-dependent seal and breaks once the temperature within the sealed portion of the uterus exceeds 103 ℃ and the pressure exceeds 1.5 psi.

Fig. 18D-18G illustrate an embodiment of an endometrial ablation catheter 1800 of the system of fig. 1P according to the present description. Referring to fig. 18D, catheter 1800 has an outer catheter or sheath 1802a and an inner catheter 1806a. In some embodiments, the inner conduit 1806a has an outer diameter of about 3.5mm. In some embodiments, the distal end 1811a of the catheter 1800 has a spherical tip 1813a to allow atraumatic insertion into the vagina of a patient, through the cervical canal 1704 of the patient, and into the uterus 1706 without requiring pre-dilation of the cervix. A plurality of rows 1814a, 1815a, 1818a, 1821a, each having a plurality of vapor delivery ports 1816a, are positioned between the distal positioning element 1812a and the proximal positioning element 1810 a. In various embodiments, the number of ports 1816a varies from 1 to 10000. In some embodiments, the number of ports 1816a is in the range of 64 to 96 ports. In an embodiment, the size of the holes in each port 1816a is in the range of 0.01 to 1mm. In one embodiment, the size of the holes is 0.1mm. In various embodiments, the vapor delivery ports 1816a are sized differently in the different rows 1814a, 1815a, 1818a, 1821a to create a vapor gradient along the catheter and within the organ volume. For example, in some embodiments, a larger delivery port is positioned at the distal row 1814a to maximize vapor in a larger volume of the cavity, and a smaller delivery port is positioned at the proximal row 1821a to maximize a smaller volume of the cavity. In an embodiment, row 1815a includes a smaller port than the port of row 1814a, while row 1818a includes a smaller port than the port of 1815a but larger port than the port of 1821 a. In other embodiments, the total surface of the ports in the distal rows 1814a, 1815a or distal halves of the catheter 1800 is greater than the total surface area of the ports in the proximal rows 1818a, 1821a or proximal halves of the catheter 1800. In another embodiment, the port size remains uniform and the port density varies in each row or region of the catheter.

Referring to fig. 18E, catheter 1800 is advanced through cervical canal 1704 and into uterus 1706 such that inner catheter 1806a is positioned within uterus 1706 and outer sheath 1802a is positioned within cervical canal 1704. Distal positioning element 1812a expands. In embodiments, the positioning element 1812a may vary in size, shape, diameter, geometry, or any other structural feature to adjust vapor distribution in a desired manner. Referring to fig. 18F, in one embodiment, the distal positioning element 1812a having a funnel shape expands and the catheter 1800 is advanced further into the uterus 1706 such that the distal end of the outer catheter 1804a is positioned adjacent the inner port 1708. In one embodiment, the proximal positioning element 1810a has a funnel shape with or without aeration, also being expanded. In addition, an external neck stabilizing element or neck collar 1803 is positioned at the external neck opening 1703. Referring to fig. 18G, steam 1819a is delivered through a plurality of ports 1816a within row 1814 a. In some embodiments, regions on the surface of the proximal positioning element 1810a provide for venting of steam or vapor. In some embodiments, the proximal positioning element 1810a includes a plurality of openings 1817a to allow ventilation. In various embodiments, the proximal positioning element 1810a is covered by a gas permeable or porous membrane to allow venting. In some embodiments, for the distal positioning element 1812, the wire mesh is coated with silicone, rather than the areas between wires in the mesh, thus allowing vapor to escape/escape from these spaces between the wires. In some embodiments, for the proximal positioning element 1810, the wire and the space between the wires are covered with silicone.

In some embodiments, a proximally located element may be attached to the intermediate catheter and allow for ventilation between the intermediate catheter and the inner catheter. In another embodiment, a proximally located element may be attached to the outer catheter and allow for ventilation between the outer catheter and the inner catheter.

Fig. 18H is a flowchart showing steps involved in ablating a patient's endometrium using an ablation catheter according to embodiments of the present disclosure. In various embodiments, the catheter is similar to those described with reference to fig. 18D-18G. In some embodiments, the method does not require pre-dilation of the cervix prior to ablation. In step 1840, the physician inserts a bulbous tip (e.g., bulbous tip 1813a of catheter 1800 in fig. 18D) through the patient's cervix and advances the catheter into the patient's uterus. The bulbous tip aids in guiding the device through the cervix and allows atraumatic insertion. In some embodiments, the bulbous tip includes an olive shaped appendage 1882, as described in the context of fig. 18O, for atraumatic insertion. In some embodiments, in step 1842, an actuator (e.g., actuator 191P on handle 190P in fig. 1P) is used to push the bulbous end forward. For example, referring to fig. 1P, on the back side of the handle, an actuator 191P in the form of a slider moves forward to activate/push the ball tip forward. In some embodiments, the bulbous tip is advanced into the uterus of the patient until its tip bottoms out. The device is then withdrawn a small distance, for example 5mm. Once the catheter is advanced into the uterus, at step 1844, the first and second positioning elements are deployed and the distal positioning element is positioned adjacent the uterus. In some embodiments, the positioning element is deployed using an actuator as described with reference to fig. 1P. In some embodiments, once the device is withdrawn, the catheter sheath is moved backward until the distal positioning element is fully deployed. The device is then advanced again until the distally located elements contact the fundus. At step 1846, a second proximally-located element is positioned over the internal cervical os to create a partial occlusion rather than a complete seal. As described with reference to fig. 18G, the area on the disk surface will provide for the venting of pressurized air or vapor. In one embodiment, ventilation occurs through the neck of the positioning element. In another embodiment, ventilation occurs between the inner conduit and the intermediate conduit or between the inner conduit and the outer conduit. At step 1848, steam or vapor is delivered into the uterus through a plurality of steam delivery ports on the catheter to ablate the endometrium. In an embodiment, the vapor is delivered for a predetermined duration. The optimal time for vapor ablation may be a function of the length of the uterus. Conventional pre-operative measurements of uterine cavity dimensions can be used to calibrate the necessary amount of water vapor. Subsequently, the proximally located element is unlocked and slid forward a small distance, e.g. 5mm. The catheter sheath remains stationary and both positioning elements are withdrawn into the sheath. Once the two positioning elements are within the sheath, the catheter device is withdrawn from the patient.

Fig. 19D-19I illustrate an endometrial ablation catheter at various stages of an exemplary deployment method of catheter 1802 according to some embodiments of the present disclosure. Fig. 19D illustrates an assembly of a catheter 1802 with a handle 1902 and a collar 1904 according to some embodiments of the present description. Fig. 19E shows the position of collar 1904 when collar 1904 is at the external orifice outside of uterus 1706 and cervix 1704 prior to deployment of catheter 1802. In this figure, uterus 1706, cervix 1704 and collar 1904 are shown on the left, while specific hand movements on handle 1902 are shown on the right to demonstrate deployment of catheter 1802. Fig. 19F illustrates an exemplary position of the hands 1990, 1991 holding the catheter 1802 and the handle 1902 to deploy the proximal positioning element 1810 according to some embodiments of the present disclosure. The user holds the outer sheath of catheter 1802 with one hand 1990 while pushing handle 1902 forward with the other hand 1991. Fig. 19G illustrates the expansion of the distally located element 1812 as the user pushes the handle 1902 of the catheter 1802 to extend the inner catheter 1806 within the uterus 1706. Fig. 19H illustrates a fully deployed distal positioning element 1812, which may be uncoated or optionally coated with silicone, and a deployed proximal positioning element 1810, according to some embodiments of the invention. So far, nothing has been in place during deployment of the catheter 1802. The user may decide to stop or adjust the position of the catheter 1802 here until a distance just short of the length of the uterus 1706 is reached to prevent perforation. In some embodiments, the user may decide to push catheter 1802 until its distal positioning element 1812 abuts the bottom of the uterus, indicating resistance at the bottom. In some embodiments, a user may rotate a dial provided on the handle 1902 clockwise to retract the proximal positioning element 1810 and further extend the distal positioning element 1812. In some embodiments, when the proximal positioning element 1810 expands, it moves in a direction toward the collar 1904, while the collar 1904 moves in the opposite direction toward the proximal positioning element 1810 (similar to a chinese finger puzzle). Fig. 19I shows rotation of the dial 1906 to further retract the first positioning member 1810 to partially seal the cervical os, thereby isolating the uterus 1706. In some embodiments, the partial seal is not perfect (an escape port is provided in the opening or hole of the proximally located element, or a venting element/groove is provided in one or both of the inner or outer catheter/sheath) to allow release of steam from the uterus, thereby maintaining a low pressure. In some embodiments, the user ablates the uterus by delivering steam through catheter 1802 for a period of about 40 seconds. In an embodiment, the proximal positioning element 1810 has a selective coating, and it provides drainage to collect water generated as the vapor condenses during and after ablation.

Fig. 18I-18N illustrate an exemplary embodiment of a distal end of an endometrial ablation catheter with a single positioning element in accordance with the present description. Fig. 18I illustrates a cross-sectional side view 1854a, side view 1854b, and distal front view 1856 of an endometrial ablation catheter 1802I according to some embodiments of the specification. Catheter 1802i is shown with braided stent 1858. The stent 1858 serves as a positioning element as described with reference to the endometrial ablation catheter herein. In an embodiment, braided stent 1858 is made of nitinol wire mesh or any other shape memory material such that stent 1858 expands into a deployed configuration, as shown in fig. 18I. In an embodiment, the support 1858 is made of a single strand mesh 1858 a. In some embodiments, the support 1858 is made from a two-wire mesh 1858 b. Fig. 18J shows a perspective side view of the catheter of fig. 18I with stent 1858 extending over inner catheter 1806 and from outer catheter 1804. When braided stent 1858 is in an expanded state and deployed within the uterus, vapors from within inner catheter 1806 are deployed. The catheter includes an atraumatic distal tip 1859 having a guidewire lumen, as described with reference to fig. 18L-18N. The guidewire lumen may be large enough to accommodate a uterine sound. Fig. 18K illustrates a cross-sectional view 1862, a perspective side view 1864, and a distal front view 1860 of a braided stent 1858 according to some embodiments of the disclosure. The proximal tapered end of the positioning element is partially or completely covered by an insulating film made of silicone or PTFE.

Fig. 18L illustrates a side perspective view of atraumatic tip 1859 for attachment to distal end 1866 of inner catheter 1806 of an endometrial ablation catheter according to some embodiments of the present disclosure. Fig. 18M illustrates a side front perspective view of atraumatic tip 1859 attached to the distal end 1866 of an inner catheter of an endometrial ablation catheter according to some embodiments of the present disclosure. Fig. 18N illustrates a top perspective view of atraumatic tip 1859 attached to the distal end 1866 of an inner catheter of an endometrial ablation catheter according to some embodiments of the present disclosure. Referring simultaneously to fig. 18L, 18M, and 18N, atraumatic tip 1859 comprises an opening 1868 for passage of a guidewire. In an embodiment, the opening 1868 is configured to receive a 0.035 inch guidewire. Atraumatic tip 1859 is connected at its distal end 1866 to an inner conduit 1806. In some embodiments, atraumatic tip 1859 is connected to distal end 1866 of inner conduit 1806 via threaded screw 1872. Atraumatic tip 1859 is made of a soft plastic material and includes a recess to receive threaded screw 1872 and lock with threaded screw 1872 to connect with inner conduit 1806.

Fig. 18O illustrates a different view of a dual positioning element ablation catheter 1802p with atraumatic olive tip 1882 according to another embodiment of the present specification. The olive-shaped tip 1882 ensures that the uterus is not pierced and provides atraumatic insertion of the catheter 1802p. In some embodiments, the olive tip attachment 1882 may include a hollow channel within its body that opens at the distal edge of the attachment 1882 to enable delivery of vapor through the channel. In some embodiments, one or more holes in the end of the attachment 1882 enable vapor delivery. All of the holes may have similar or varying diameters. Two positioning elements, proximal positioning element 1884 and distal positioning element 1886, are provided with a catheter 1802p. Positioning elements 1884 and 1886 are in the form of caps, wherein distal cap 1886 may have a diameter ranging from 25mm +/-2mm to 34mm +/-2mm, and proximal cap 1884 may have a diameter ranging from 25mm +/-2mm to 30mm +/-2 mm. The distance between the two covers 1884 and 1886 may be in the range of 28mm to 36.4 mm. Each shroud 1884/1886 may have a depth of about 5mm along the length of the catheter 1802p. In an embodiment, each cap 1884/1886 is attached to shaft 1888 using a soft attachment mechanism with PTFE strands. The distance between the distal end of the distal cap 1886 and the distal tip of the olive tip 1882 may be about 16.7mm. The shaft portion 1888a extending between the distal cap 1886 and the olive tip attachment 1882 may also include one or more holes for distributing vapor during ablation. In some embodiments, apertures may also be present before the distal hood 1886, between the distal hood 1886 and the proximal hood 1884, for spreading the vapor. The length of the olive shaped tip 1882 may extend about 6mm. The diameter of the distal tip of the olive tip 1882 may be in the range of 3.4+/-0.05 mm. Vapor enters the catheter 1802p shaft 1888 and exits through the openings 1889 along the shaft 1882 during ablation. The shaft 1888 between the two shrouds 1884 and 1886 may have a diameter of about 1.1+/-0.05 mm. In an embodiment, there are additional openings in the olive tip 1882 and the catheter shaft 1888a distal to the distal cap 1886. The shaft 1888a extending from the distal end of the distal cap 1886 to the olive tip 1882 may be made of nitinol and have a diameter of about 0.4 mm.

Fig. 18P illustrates a distal end of an ablation catheter 1878 having a distally located element 1879 and a plurality of ports 1877 along the length of the catheter shaft 1875, according to some embodiments of the disclosure. Fig. 18Q illustrates a distal end of an ablation catheter 1891 having a distal olive tip 1893, a positioning element 1895, and a plurality of ports 1897 along the length of the catheter shaft 1899, according to some embodiments of the disclosure. The olive shaped tip 1893 is rounded and bulbous and is configured to prevent trauma to body tissue. The cross-sectional view of the olive-shaped tip 1893 shows a diagonal opening or hole 1890 in the tip 1893. In an embodiment, the olive shaped tip 1893 has four identical and symmetrically configured openings in its distal spherical tip. Each opening 1890 is connected to the hollow catheter shaft 1899 and extends outwardly from the hollow catheter shaft 1899 beyond the distal cap 1886. During ablation, the opening 1890 provides an outlet for vapor exiting the distal side of the positioning element 1895. Fig. 18R illustrates a side view of the distal end of an ablation catheter 1850 according to some embodiments of the present disclosure, the ablation catheter 1850 having a distal olive tip 1857, a distal positioning element 1853, a proximal positioning element 1851, and a plurality of ports 1855 along the length of the catheter shaft 1869. Fig. 18S shows a rear perspective view of the catheter 1850 of fig. 18R. The ablation catheter 1850 includes a connector 1867 at its proximal end for connection to a proximal catheter section.

Fig. 18T illustrates the distal end of an ablation catheter 1802T having a semicircular opening 1802c at the distal end and a distal positioning element 1896 according to some embodiments of the present description. Although the figure shows a semi-circular opening 1802c, the opening may be other shapes, such as, but not limited to, semi-rectangular. In some embodiments, the positioning element 1896 is deformable, flattening as it is pushed against the bottom of the uterus. The distal end 1894 of the catheter 1802t may be open or covered, but in either case includes a semicircular opening 1802c. In some embodiments, the rounded distal end of the shaft 1888 is configured to include at least three equidistant semicircular openings 1802c. In some embodiments, distal end 1894 is closed with cap 1849. In some embodiments, the cover 1849 has a diameter of about 1.65 mm. In some embodiments, cap 1849 is welded to distal end 1894. The cap 1849 is used to close the open distal end of the catheter 1802t, while the semicircular opening 1802c still allows for the vapor to leave and reach the opening at the bottom of the uterus during ablation. In some embodiments, the ablation catheter 1802t does not include a cap 1849. In an embodiment, the shaft 1847 of the catheter 1802t includes a plurality of ports 1843 for delivering steam to other portions of the uterus.

Fig. 18U illustrates the distal end of an ablation catheter 18100a having a spherical distal positioning element 18106 and a cap 18112 extending over all or a portion of the positioning element 18106, according to an exemplary embodiment of the present disclosure. Fig. 18V illustrates a distal end of an ablation catheter 18100b with a spherical distal positioning element 18108 according to another example embodiment of this disclosure. Fig. 18W illustrates a distal end of an ablation catheter 18100c with a conical distal positioning element 18110 according to still another example embodiment of the present disclosure. The embodiments of fig. 18U, 18V and 18W may be used in catheter devices for endometrial ablation as well as for bladder ablation, as described in subsequent figures. Referring simultaneously to fig. 18U, 18V and 18W, the distal tip 18102 of the catheter shaft extends into the positioning elements 18106, 18108, 18110. The distal tip 18102 is an extension of the catheter shaft and is configured with a smooth rounded tip at its distal-most end. In some alternative embodiments, the distal tip 18102 is flexible and configured to have a semi-circular shape, similar to the embodiment of fig. 18T. A portion of the distal tip 18102 has at least one or more openings 18104 to provide an outlet for vapor during ablation. In some embodiments, the opening 18104 is circular, slotted, semi-circular, or any other shape. In some embodiments, 1 to 1000 openings 18104 are distributed over a length of 3 to 7cm over the length and surface of the distal tip 18102, with each opening having a length or diameter in the range of 0.1 to 1 mm. In some embodiments, 64 to 96 openings are distributed over the distal tip 18102. In an embodiment, the distal tip 18102 of the catheter is enclosed within a positioning element, such as the ball element 18106 of fig. 18U, the ball element 18108 of fig. 18V, or the inverted three-dimensional (3D) tapered wire mesh 18110 of fig. 18W. In an embodiment, the positioning elements 18106, 18108 and 18110 are configured to compress or deform as they contact the bottom of the uterus or bladder. The tip of each positioning element 18106, 18108, and 18110 is free-floating, and the positioning elements 18106, 18108, and 18110 are attached to the respective catheter at the proximal neck of the distal tip 18102. Thus, positioning elements 18106, 18108 and 18110 act as a "buffer" and prevent uterine fundus trauma while also allowing vapor to be dispensed at the fundus. Each positioning element 18106, 18108 and 18110 is constructed from a wire mesh such that there is sufficient space between the wires of the wire mesh for vapor to exit. Referring to fig. 18U, a cap 18112 is provided to partially cover the openings through the wire mesh on the proximal side (underside) of the spherical positioning element 18106 to prevent vapor flow in that direction. In some embodiments, the cap 18112 is silicone. Fig. 18V shows an alternative embodiment of a spherical positioning element 18106 in the form of a spherical positioning element 18108 that does not include a cap 18112. Fig. 18W illustrates the use of a tapered positioning element 18110, the tapered positioning element 18110 being similar to an inverted cone and configured to approximate the shape of a uterus.

Fig. 18X illustrates an atraumatic soft tip 18114 of a catheter shaft 18116 for insertion into a cervix 18118 according to some embodiments of the present disclosure. In some embodiments of the invention, the catheter shaft 18116 is inserted through the patient's vagina 18115 and into and through a portion of the patient's cervix. During delivery, the distal cap 18120, the inner catheter shaft 18126, and the proximal cap 18122 are all disposed within the catheter shaft 18120 such that the soft tip 18114 includes the distal end of the catheter. Soft tip 18114 is configured to be soft and atraumatic to vaginal cavity 18115, external cervical os 18117, and cervix 18118 during positioning. During deployment, the inner catheter shaft 18126 extends from the catheter shaft 18116, through the cervix 18118 and into the uterus 18124, such that the inner catheter shaft 18126 is positioned within the uterus 18124 proximate the fibroid/tumor/lesion 18128 in need of ablation treatment. The distal cap 18120 is deployed near the bottom 18132 of the uterus 18124 and the proximal cap 18122 is deployed near the internal cervical os 18119 to securely position the inner catheter shaft 18126 within the uterus. The opening in the inner catheter shaft 18126 is then used to deliver steam or vapor 18130 to ablate the target area. In some embodiments, a 40 second steam ablation cycle is delivered to the uterus. During ablation, the distal cap 18120 may be pulled back slightly to ensure complete coverage of the target area, including the bottom 18132 of the uterus. Atraumatic soft tip 18114 ensures protection of the patient's body tissue during insertion of the catheter and withdrawal of distal cap 18120.

Various Endometrial Ablation (EA) devices according to embodiments of the present disclosure provide a number of advantages over existing endometrial ablation methods. The vapor ablation by the embodiments of the present specification effectively ablates endometrial tissue for a wider variety of uterine shapes than is currently permitted by EA procedures. The systems and methods of the present disclosure ablate endometrial tissue even in the presence of fibroids or polyps.

Fig. 19J illustrates a distal end of an ablation catheter 1910 having a proximal positioning element 1911, a distal positioning element 1912, and a plurality of ports 1913 along a length of a catheter shaft 1914 according to some embodiments of the present description. In an embodiment, catheter 1910 includes a proximal connector 1916 for connecting proximal positioning element 1911 and for connecting catheter 1910 to a proximal catheter portion, and a distal connector 1917 for connecting distal positioning element 1912. In some embodiments, the positioning elements 1911, 1912 have a conical or circular shape. In some embodiments, the positioning element is connected via a suture or wire 1918.

Fig. 19K illustrates a distal end of an ablation catheter 1920 having a proximal positioning element 1921, a distal positioning element 1922, a distal olive tip 1925, and a plurality of ports 1923 along the length of a catheter shaft 1924 according to some embodiments of the present disclosure. In some embodiments, the catheter 1920 includes a proximal connector 1926, the proximal connector 1926 having threads for connection to a proximal catheter portion.

Fig. 19L illustrates a connector 1930 for connecting a distally located element to the distal end of an ablation catheter, according to some embodiments of the present disclosure. In an embodiment, the connector 1930 has a flat distal end 1931 configured to fit coaxially over a distal portion of an ablation catheter, and includes a plurality of openings 1932 for sutures or wire passage to secure a distally located element. In an embodiment, connector 1933 includes an opening at its distal end to allow steam to escape and reach the bottom of the uterus.

Fig. 19M illustrates another connector 1935 for connecting a distally located element to the distal end of an ablation catheter according to other embodiments of the present disclosure. In an embodiment, the connector 1935 has a rounded distal end 1936 configured to prevent trauma to body tissue, is configured to fit coaxially over a distal portion of an ablation catheter, and includes a plurality of openings 1937 for passage of sutures or wires to secure a distal positioning element.

Fig. 19N illustrates a connector 1940 for connecting a proximally located element to a distal end of an ablation catheter, according to some embodiments of the present disclosure. In an embodiment, the distal end of the connector 1940 includes a plurality of openings 1941 for passage of sutures or wires to secure the proximally located element, and the proximal end 1942 of the connector is configured to connect to a proximal catheter portion.

Fig. 19O illustrates another connector 1945 for connecting a proximally located element to the distal end of an ablation catheter according to other embodiments of the specification. In an embodiment, the distal end of the connector 1945 includes a plurality of openings 1946 for passage of sutures or wires to secure the proximally-located element, and the proximal end 1947 of the connector is configured to connect to a proximal catheter portion.

Fig. 19P illustrates a shaft 1950 of an ablation catheter, depicting a plurality of ports 1951, according to some embodiments of the present disclosure. Port 1951 is configured to allow release of steam from lumen 1952 into the uterus. In some embodiments, ports 1951 are arranged in rows 1953.

Fig. 20A illustrates endometrial ablation in a female uterus by use of an ablation device in accordance with an embodiment of the present disclosure. A cross-section of a female genital tract is shown that includes vagina 2970, cervix 2971, uterus 2972, endometrium 2973, fallopian tube 2974, ovary 2975, and uterine fundus 2976. The catheter 2977 of the ablation device is inserted into the uterus 2972 through the cervix 2971 at the cervical os. In one embodiment, the catheter 2977 has two positioning elements, a tapered positioning element 2978 and a disk-shaped positioning element 2979. The positioning element 2978 is conical, wherein the insulating film partially or completely covers the conical positioning element 2978. The tapered element 2978 positions the catheter 2977 in the center of the cervix 2971 and the insulating film prevents thermal energy or ablative agent from escaping the cervix 2971 through the port 2971 o. Second disc-shaped positioning element 2979 deploys near the bottom of uterus 2976, positioning catheter 2977 in the middle of the cavity. The ablative agent 2978a passes through the infusion port 2977a for uniform delivery of the ablative agent 2977a into the uterine cavity. The predetermined length "l" of the ablation section of the catheter and the diameter "d" of the positioning element 2979 allow for an estimation of the lumen size and are used to calculate the amount of thermal energy required to ablate the endometrial lining. In one embodiment, the positioning elements 2978, 2979 are also used to move endometrial tissue away from the infusion port 2977a on the catheter 2977 to allow for the delivery of ablative agents. An optional temperature sensor 2907 deployed near the endometrial surface is used to control the delivery of ablative agent 2978 a. Alternative topographic mapping using a plurality of infrared, electromagnetic, acoustic or radio frequency energy emitters and sensors may be used to define the cavity size and shape of a patient having an irregular or deformed uterine cavity due to conditions such as fibroids. In addition, data from diagnostic tests may be used to determine uterine cavity size, shape or other characteristics. In one embodiment, the distal positioning element 2979 is also conical and is partially or completely covered with an insulating film. The various shaped positioning elements described herein may be used in various combinations to achieve a desired therapeutic goal.

In one embodiment, the ablative agent is steam or vapor that contracts upon cooling. The vapor/steam becomes water with a smaller volume than the cryogen that will expand or the hot fluid used in the hydrothermal ablation (which volume remains constant while contacting the tissue). For both cryogen and hot fluid, increased energy delivery is associated with increased volume of ablative agent, which in turn requires a mechanism for removing the agent, otherwise the medical provider would experience complications such as perforation. However, the vapor becomes water upon cooling, which occupies significantly less volume; thus, increased energy delivery is independent of increased volume of residual ablative agent, thereby eliminating the need for continued removal. This further reduces the risk of leakage of thermal energy through the fallopian tube 2974 or cervix 2971, thereby reducing any risk of thermal damage to adjacent healthy tissue.

In one embodiment, the positioning appendage must be separated from the ablation zone by a distance greater than 0.1mm, preferably 1mm, and more preferably 1 cm. In another embodiment, the positioning accessory may be in the ablation zone as long as it does not cover a significant surface area. For endometrial ablation, 100% of the tissue need not be ablated to achieve the desired therapeutic effect. Thus, in some embodiments, the positioning element may contact and cover 5% or less of the surface area of the endometrium.

In one embodiment, the preferred distally located accessory is an uncovered wire mesh that is positioned adjacent to the intermediate body region. In one embodiment, the preferred proximal positioning device is a covered wire mesh that is pulled into the cervix, centers the device, and closes the cervix and/or the internal os. Fig. 19A, 19B, and 19C illustrate some of the various embodiments of the positioning device. One or more such positioning devices may help compensate for anatomical changes in the uterus. The distal positioning means is preferably oval with a major axis between 0.1mm and 10cm (preferably 1cm to 5 cm) and a minor axis between 0.1mm and 5cm (preferably 0.5cm to 1 cm). The proximal positioning means is preferably circular with a diameter of between 0.1mm and 10cm, preferably between 1cm and 5 cm.

In another embodiment, the catheter is a coaxial catheter comprising an outer catheter and an inner catheter, wherein upon insertion, the distal end of the outer catheter engages and stops at the cervix, and the inner catheter extends into the uterus until its distal end contacts the bottom of the uterus. Fig. 18A illustrates an exemplary embodiment of a catheter configuration according to the present description. The length of the internal catheter that has entered the uterus is then used to measure the depth of the uterine cavity and determine the amount of ablative agent to be used. The ablative agent is then delivered to the uterine cavity through at least one port on the inner catheter. In one embodiment, intra-uterine intra-luminal pressure remains below 100mm Hg, preferably below 30mm Hg (no more than 10% above atmospheric pressure) during treatment. In one embodiment, the coaxial catheter further comprises a pressure sensor to measure intra-luminal pressure. In one embodiment, the coaxial catheter further comprises a temperature sensor for measuring the temperature within the lumen. In one embodiment, the ablative agent is a vapor, and the vapor is released from the catheter at a pressure of less than 100mm Hg and preferably less than 30mm Hg. In one embodiment, the vapor is delivered at a temperature of 90 to 100 ℃. In another embodiment, the vapor is delivered at a temperature between 100 and 110 ℃.

Fig. 20B is a schematic illustration of a coaxial catheter 2920 for endometrial tissue ablation according to one embodiment of the disclosure. The coaxial catheter 2920 includes an inner catheter 2921 and an outer catheter 2922. In one embodiment, the inner catheter 2921 has one or more ports 2923 for delivering an ablative agent 2924. In one embodiment, the ablative agent is a vapor. In one embodiment, the outer catheter 2922 has a plurality of fins 2925 to engage the cervix to prevent steam from escaping from the uterus and entering the vagina. In one embodiment, the fins are constructed of silicone. Fins 2925 ensure an incomplete cervical seal. In an embodiment, a plurality of holes are configured in the fins 2925 that direct steam escaping from the uterus into the lumen of the outer catheter 2922. In one embodiment, the outer conduit 2922 includes a luer lock 2926 to prevent steam from escaping between the inner conduit 2921 and the outer conduit 2922. In one embodiment, the inner catheter 2921 includes measurement markings 2927 to measure the depth of insertion of the inner catheter 2921 beyond the end of the outer catheter 2922. Optionally, in various embodiments, one or more sensors 2928 are incorporated into the inner catheter 2921 to measure intra-luminal pressure or temperature.

Fig. 20C is a flowchart listing steps involved in an endometrial tissue ablation procedure using a coaxial ablation catheter, according to an embodiment of the disclosure. At step 2902, a coaxial catheter is inserted into the vagina of the patient and advanced to the cervix. Then, at step 2904, the coaxial catheter is advanced such that the fins of the outer catheter engage the cervix, effectively stopping the advancement of the outer catheter at that point. The inner catheter is then advanced in step 2906 until the distal end of the inner catheter contacts the bottom of the uterus. The depth of insertion is then measured using measurement markers on the inner catheter to determine the amount of ablative agent to be used in the procedure, step 2908. At step 2910, the luer lock is tightened to prevent any steam from escaping between the two conduits. Then, at step 2912, steam is delivered through the lumen of the inner catheter and into the uterus via a delivery port on the inner catheter to ablate endometrial tissue.

Fig. 20D is a schematic illustration of a bifurcated coaxial catheter 2930 for endometrial tissue ablation according to one embodiment of the disclosure. The catheter 2930 includes a first elongate shaft 2932, the first elongate shaft 2932 having a proximal end, a distal end, and a first lumen therein. The first lumens are split in the distal end to form a coaxial shaft 2933. The distal end of first shaft 2932 also includes a first positioning element or cervical plug 2934 that closes the cervix of the patient. The catheter 2930 diverges as it extends distally from the cervical plug 2934 to form a second catheter shaft 2935 and a third catheter shaft 2936. The second and third catheter shafts 2935, 2936 each include a proximal end, a distal end, and a shaft body having one or more vapor delivery ports 2937. Second catheter shaft 2935 and third catheter shaft 2936 include a second lumen and a third lumen, respectively, for delivering an ablative agent. The distal ends of the second and third catheter shafts 2935, 2936 include second and third positioning elements or tubal plugs 2938, 2939, respectively, designed to engage the fallopian tubes of the patient and prevent ablation energy from escaping during the ablation treatment procedure. The tubal plugs 2938, 2939 also serve to position the second shaft 2935 and the third shaft 2936, respectively, in an intramural portion or isthmus of the patient's fallopian tube. The second and third catheter shafts 2935, 2936 may independently extend coaxially, and the length of each shaft 2935, 2936 is used to determine the size of the endometrial cavity of the patient. The ablative agent 2940 travels through the first catheter shaft 2932, through the second catheter shaft 2935 and the third catheter shaft 2936, and out of the vapor delivery port 2937 and into the endometrial cavity to ablate endometrial tissue.

Fig. 20E is a flowchart listing steps of a method of ablating endometrial tissue using the ablation catheter of fig. 20D, according to an embodiment of the specification. In step 2943, a coaxial catheter is inserted into the cervix of the patient and the cervix is engaged with the cervical plug. The catheter is then advanced at step 2944 until each of the oviduct plugs is adjacent to the oviduct opening. Each fallopian tube is then engaged with the fallopian tube plug at step 2945 and the size of the endometrial cavity is measured. The measurement is based on the length of each catheter shaft that has been advanced. At step 2946, the measured dimensions are used to calculate the amount of ablative agent needed to perform ablation. Then, at step 2947, a calculated dose of ablative agent is delivered through the catheter shaft and into the endometrial cavity to produce the desired endometrial ablation.

Fig. 20F is a schematic illustration of a bifurcated coaxial catheter 2950 having expandable elements 2951, 2953 for endometrial tissue ablation according to one embodiment of the present disclosure. Similar to the catheter 2930 of fig. 20D, the catheter 2950 depicted in fig. 20F includes a first elongate coaxial shaft 2952, the first elongate coaxial shaft 2952 having a proximal end, a distal end, and a first lumen therein. The first lumens are split in the distal end to form a coaxial shaft 2949. The distal end of first shaft 2952 also includes a first positioning element or cervical plug 2954 that closes the cervix of the patient. The catheter 2950 diverges as it extends distally from the cervical plug 2954 to form a second catheter shaft 2955 and a third catheter shaft 2956. Second catheter shaft 2955 and third catheter shaft 2956 each include a proximal end, a distal end, and a catheter shaft body having one or more vapor delivery ports 2957. Second catheter shaft 2955 and third catheter shaft 2956 include a second lumen and a third lumen, respectively, for delivering an ablative agent. The distal ends of second and third catheter shafts 2955, 2956 include second and third positioning elements or tubal plugs 2958, 2959, respectively, designed to engage the patient's fallopian tubes and prevent ablation energy from escaping during the ablation treatment procedure. The tubal plugs 2958, 2959 also serve to position the second shaft 2955 and the third shaft 2956, respectively, in an intramural portion or isthmus of the patient's fallopian tube. Second and third catheter shafts 2955, 2956 may independently extend coaxially, and the length of each catheter shaft 2955, 2956 is used to determine the size of the endometrial cavity of the patient.

The catheter 2950 also includes a first expandable member or balloon 2951 and a second expandable member or balloon 2953 that includes a coaxial balloon structure. In one embodiment, the first balloon 2951 is a compliant balloon structure and the second balloon 2953 is a non-compliant balloon structure shaped to approximate the shape, size, or volume of the uterine cavity. In another embodiment, second balloon 2953 is partially compliant. In another embodiment, the compliance of the two balloons 2951, 2953 is substantially equal. The balloons 2951, 2953 are attached to the second and third catheter shafts 2955, 2956 along the inner surface of each shaft 2955, 2956. First inner balloon 2951 is positioned within second outer balloon 2953. The inner balloon 2951 is designed to be inflated with air, and a first volume of the inner balloon 2951 is used to measure the size of the patient's endometrial cavity. The ablative agent 2961 is introduced into the catheter 2950 at the proximal end of the catheter 2950 and travels through the first catheter shaft 2952 and into the second catheter shaft 2955 and the third catheter shaft 2956. The second catheter shaft 2955 and the third catheter shaft 2956 are designed to release ablation energy 2962 through the delivery port 2957 and into the space 2960 between the two balloons 2951, 2953. Some of the ablation energy 2963 is delivered to the air in the inner balloon 2951, expanding its volume from the first volume to a second volume, resulting in further expansion of the inner balloon 2951 to further occlude the patient's endometrial cavity for ideal vapor delivery. In one embodiment, the second volume is less than 25% greater than the first volume. The dilation also forces the tubal plugs 2958, 2959 to further engage the openings of the fallopian tubes. A portion of the ablative agent or ablative energy 2964 diffuses out of the heat permeable outer balloon 2953 and into the endometrial cavity, ablating endometrial tissue. In various embodiments, the thermal heating of the air in the balloon occurs through the wall of the inner balloon, through the length of the catheter, or through both. In one embodiment, the catheter 2950 includes an optional fourth catheter shaft 2965, the fourth catheter shaft 2965 extending from the first catheter shaft 2952 and extending within the inner balloon 2951 between the second catheter shaft 2955 and the third catheter shaft 2956. Thermal energy from within the fourth catheter shaft 2965 is used to further expand the inner balloon 2951 and assist in ablation.

In one embodiment, the volume of the inner balloon 2951 is used to control the pressure exerted by the outer balloon 2953 on the uterine wall. The pressure in the inner balloon 2951 is monitored and air is added to the inner balloon 2951 or removed from the inner balloon 2951 to maintain a desired therapeutic pressure in the outer balloon 2953.

Fig. 20G is a schematic illustration of the catheter 2950 of fig. 20F inserted into a patient's uterine cavity 2966 for ablation of endometrial tissue 2967, in accordance with one embodiment of the present disclosure. The catheter 2950 has been inserted with the first shaft 2952 extending through the patient's cervix 2968 such that the second shaft 2955 is positioned along a first side of the patient's uterine cavity 2966 and the third shaft 2956 is positioned along a second side opposite the first side. This positioning deploys the inner and outer balloons 2951, 2953 between the second and third shafts 2955, 2956. In the illustrated embodiment, the catheter 2950 includes an optional fourth shaft 2965 to further expand the inner balloon 2951 with thermal energy and assist in ablation of endometrial tissue 2967. In one embodiment, the inner balloon 2951 is optional and the outer balloon 2953 performs the functions of sizing and delivering the ablative agent. In one embodiment, the outer balloon includes a heat sensitive aperture 2969 that is closed at room temperature and open at a temperature above body temperature. In one embodiment, the pores are composed of a Shape Memory Alloy (SMA). In one embodiment, the SMA is nitinol. In one embodiment, the austenite finish (Af) temperature of the SMA or the temperature at which the transformation from martensite to austenite finish upon heating (the alloy undergoes a shape change to become the open pores 2969) is greater than 37 ℃. In other embodiments, the Af temperature of the SMA is greater than 50 ℃ but less than 100 ℃.

Fig. 20H is a flowchart listing steps of a method of ablating endometrial tissue using the ablation catheter of fig. 20F in accordance with one embodiment of the specification. In step 2980, a coaxial catheter is inserted into the cervix of the patient and the cervix is engaged with the cervical plug. The catheter is then advanced at step 2981 until each of the tubal plugs is proximate the tubal opening. Then, at step 2982, each fallopian tube is engaged with a fallopian tube plug which also deploys a coaxial balloon in the endometrial cavity, and the size of the endometrial cavity is measured. The measurement is based on the length of each catheter shaft that has been advanced and the first volume required to expand the inner balloon to a predetermined pressure. At step 2983, the inner balloon is inflated to the predetermined pressure, and the volume of the endometrial cavity is calculated using the first volume of the inner balloon at the pressure. The measured dimensions are then used in step 2984 to calculate the amount of ablative agent needed to perform ablation. Then, at step 2985, a calculated dose of ablative agent is delivered through the catheter shaft and into the space between the coaxial balloons. Some of the ablative energy is transferred into the inner balloon to expand the inner balloon to a second volume that further expands the endometrial cavity and, optionally, further pushes the oviduct plug into the oviduct opening to prevent thermal energy from escaping. Another portion of the ablation energy passes through the heat permeable outer balloon to produce the desired endometrial ablation.

In another embodiment, a steam ablation device for ablating endometrial tissue includes a catheter designed to be inserted into an endometrial cavity through a cervical os, wherein the catheter is connected to a steam generator for generating steam, and includes at least one port positioned in the endometrial cavity to deliver steam into the endometrial cavity. Steam is delivered through the port and heats and expands the air in the endometrial cavity to maintain the endometrial cavity pressure below 200mm Hg, desirably below 50mm Hg. In one embodiment, an optional pressure sensor measures pressure and maintains intra-luminal pressure at a desired therapeutic level, wherein the endometrial cavity is optimally distended to allow for even distribution of ablation energy without the risk of significant leakage of ablation energy beyond the endometrial cavity and damage to adjacent normal tissue.

Fig. 20I is a schematic illustration of a bifurcated coaxial catheter 2970 for endometrial tissue ablation in accordance with another embodiment of the present disclosure. Forming a seal at the cervix is undesirable because it creates a closed cavity, resulting in an increase in pressure as steam is delivered into the uterus. This increases the temperature of the intra-uterine air, resulting in thermal expansion and further increases in intra-luminal pressure. This pressure rise may force steam or hot air out of the fallopian tubes, causing thermal damage to the abdominal viscera. This requires continuous measurement of the intra-luminal pressure and active removal of the ablative agent to prevent leakage of thermal energy out of the lumen. Referring to fig. 20I, the catheter 2970 includes a coaxial handle 2971, a first positioning element 2972, a first bifurcated catheter arm 2935I having a second positioning element 2938I at its distal end, a second bifurcated catheter arm 2936I having a third positioning element 2939I at its distal end, and a plurality of infusion ports 2937I along each bifurcated catheter arm 2935I, 2936I. The catheter 2970 also includes a vent tube 2976, the vent tube 2976 extending through the coaxial handle 2971 and through the first positioning element 2972 such that when the first positioning element 2972 is positioned against the cervix, the lumen of the patient's uterus is in fluid communication with the exterior of the patient's body. This prevents a tight seal from being formed when the catheter 2970 is inserted into the cervix. Since the cervix is normally in the closed position, insertion of any device will inadvertently result in the formation of an undesirable seal. The vent tube allows heated air or additional vapor 2940i to expand as the vapor is delivered and the pressure within the chamber rises to be expelled. In some embodiments, the vent tube includes a valve for unidirectional flow of air.

Fig. 20J is a schematic illustration of a bifurcated coaxial catheter 2973 for endometrial tissue ablation in accordance with a further embodiment of the present disclosure. The catheter 2973 includes a coaxial handle 2974, a first positioning element 2975, a first bifurcated catheter arm 2935j having a second positioning element 2938j at its distal end, a second bifurcated catheter arm 2936j having a third positioning element 2939j at its distal end, and a plurality of infusion ports 2937j along each bifurcated catheter arm 2935j, 2936 j. The catheter 2973 also includes two vent tubes 2991, 2992 extending through the coaxial handle 2974 and through the first positioning element 2975 such that when the first positioning element 2975 is positioned against the cervix, the lumen of the patient's uterus is in fluid communication with the exterior of the patient's body. This prevents a tight or complete seal from being formed when the catheter 2973 is inserted into the cervix. The vent tubes 2991, 2992 allow heated air or additional vapor 2940j to expand as vapor is delivered and the pressure within the chamber rises to be expelled. In some embodiments, the vent tubes 2991, 2992 include valves for unidirectional flow of air.

Fig. 20K is a schematic diagram of a water cooled catheter 2900K for endometrial tissue ablation according to one embodiment of the disclosure. The catheter 2900k includes an elongate body 2901k having a proximal end and a distal end. The distal end includes a plurality of ports 2905k for delivering steam 2907k for tissue ablation. Sheath 2902k extends along body 2901k of catheter 2900k to a point proximal to port 2905k. During use, water 2903k circulates through the sheath 2902k to cool the catheter 2900k. Steam 2907k for ablation and water 2903k for cooling are supplied to the catheter 2900k at the proximal end of the catheter 2900k.

Fig. 20L is a schematic view of a water cooled catheter 2900L for endometrial tissue ablation and positioned in a patient's uterus 2907L according to another embodiment of the disclosure. The catheter 2900l includes an elongate body 2901l, a proximal end, a distal end, and a sheath 2902l covering a proximal portion of the body 2901 l. Cervical cup 2904l extends from sheath 2902l and is in fluid communication with sheath 2902l. The catheter 2900l also includes a plurality of ports 2906l at its distal end configured to deliver ablation vapors 2908l to the uterus 2907l. Steam 2908l is supplied to the proximal end of catheter 2900 l. The port 2906l is positioned on the catheter body 2901l distal to the sheath 2902l. Cervical cup 2904l is configured to cover cervix 2909l, and the distal end of sheath 2902l extends into cervical tube 2910 l. Water 2903l is circulated through sheath 2902l and cervical cup 2904l to cool cervical tube 2910l and/or cervix 2909l while steam 2908l is delivered through steam delivery port 2906l to ablate endometrial lining 2911l.

In various embodiments, the ablation therapy provided by the steam ablation system of the present specification is delivered to achieve the following treatment endpoints for uterine ablation: maintaining the tissue temperature at 100 ℃ or less; increasing hemoglobin of the patient by at least 5% or at least 1gm% relative to pre-treatment hemoglobin; menstrual blood flow is reduced by at least 5% relative to pre-treatment menstrual blood flow as measured by the weight of the catamenial pad; ablation of endometrial tissue is in the range of 10% to 99%; the duration of menstrual flow is reduced by at least 5% relative to pre-treatment menstrual flow; the amenorrhea rate is reduced by at least 10% relative to the pre-treatment amenorrhea rate; and patient reports greater than 25% satisfaction with uterine ablation procedures.

Fig. 20M is a schematic view of a water cooled catheter 2900M for cervical ablation according to one embodiment of the present disclosure, fig. 20N is a schematic view of the catheter 2900M of fig. 20M positioned in a patient's cervix 2909N. Referring simultaneously to fig. 20M and 20N, the catheter 2900M includes an elongated body 2901M, a proximal end, a distal end, and a water cooled tip 2902M at its distal end. Cervical cup 2914m is attached to catheter body 2901m and includes a plurality of ports 2906m in fluid communication with the proximal end of catheter 2900 m. Steam 2908m is provided at the proximal end of catheter 2900m and is delivered to cervix 2909n via port 2906m. In an embodiment, steam 2908m ablates transition region 2912n at cervix 2909n. The water-cooled tip 2902m of the catheter 2900m cools the cervical tube 2910n during ablation. In various embodiments, the catheter tip may be cooled using cooling methods known in the art.

Fig. 20O is a flowchart listing the steps involved in performing cervical ablation using the catheter of fig. 20M. At step 29020, the distal tip of the catheter is inserted into the cervical canal until the cervical cup of the catheter surrounds the cervix. At step 2904, water is circulated through the water-cooled tip to cool the cervical canal. At step 29060, steam is passed through a steam delivery port in the cervical cup to ablate the cervix.

In various embodiments, the ablation therapy provided by the steam ablation system of the present specification is delivered to achieve the following therapeutic endpoints of cervical ablation: maintaining the tissue temperature at 100 ℃ or less; ablating cervical mucosa without significant damage to the cervical canal; ablating at least 50% of the surface area of the abnormal cervical mucosa of the target such that, upon healing, the abnormal cervical mucosa is replaced with normal cervical mucosa; elimination of more than 25% of abnormal cervical mucosa by colposcopy assessment; and ablating more than 25% of the abnormal cervical mucosa and less than 25% of the total cervical canal length.

Fig. 21A is a flowchart showing a method of endometrial tissue ablation according to an embodiment of the disclosure. Referring to fig. 21A, a first step 3001 includes inserting a catheter of an ablation device through a cervix and into a uterus of a patient, wherein the catheter includes a hollow shaft through which an ablative agent may travel, at least one first positioning element, at least one second positioning element distal to the at least one first positioning element, and at least one infusion port for delivering the ablative agent. In one embodiment, the ablation device includes a controller including a microprocessor for controlling delivery of the ablative agent. The catheter is passed through the cervix such that the first positioning element is positioned in the cervix and the second positioning element is positioned in the uterine cavity. In one embodiment, the second positioning element is positioned near the bottom of the uterus. In step 3002, the two positioning elements are deployed such that the first positioning element contacts the cervix, the second positioning element contacts a portion of the uterine cavity, and the catheter and infusion port are positioned within the uterine cavity of the patient. Finally, in step 3005, an ablative agent is delivered through the infusion port to ablate endometrial tissue.

Optionally, in step 3003, a sensor is used to measure at least one dimension of the uterine cavity, and in step 3004, a measurement is used to determine the amount of ablative agent to be delivered.

Fig. 21B is a flowchart illustrating a method of ablating uterine fibroids. Referring to fig. 21B, a first step 3011 includes inserting a hysteroscope through the cervix and into the uterus of the patient. Next, in step 3012, a catheter of the ablation device is passed through the hysteroscope, wherein the catheter includes a hollow shaft through which an ablative agent can travel, a puncture tip at a distal end thereof, at least one positioning element, and a plurality of needles on the distal end of the catheter, and is configured to deliver the ablative agent to the uterine fibroid. In one embodiment, the ablation device includes a controller including a microprocessor for controlling delivery of the ablative agent. The catheter is passed through the hysteroscope such that the penetrating tip of the catheter penetrates the uterine fibroid. In a next step 3013, at least one positioning element is deployed to position the catheter within the uterine fibroid such that the plurality of needles on the distal end of the catheter are positioned within the uterine fibroid. Finally, in step 3014, an ablative agent is delivered through the needle to ablate the fibroid. In some embodiments, the positioning element positions the catheter in the fibroid about 1/2 of the average lateral dimension of the fibroid. In other embodiments, the positioning element positions the catheter in the fibroid about 25% to 75% of the average lateral dimension of the fibroid.

Fig. 21C-21I illustrate exemplary embodiments of a distal end of an endometrial ablation catheter with a single positioning element in accordance with some embodiments of the specification. Fig. 21J illustrates a system for endometrial ablation with a catheter having a single positioning element at its distal end according to various embodiments of the disclosure. Embodiments include an inner conduit containing a coaxial electrode therein to convert brine to steam. The inner coaxial chamber including the electrode is insulated from the outer surface and tissue by the inner catheter, and in some embodiments, is insulated from the outer surface and tissue by an outer sheath covering the inner catheter. The single positioning element shown in fig. 21D-21I has a proximal surface and a distal surface. In an embodiment, the proximal surface functions similarly to the proximal disc/positioning element and the distal surface functions similarly to the distal disc/positioning element, wherein the proximal disc/positioning element and the distal disc/positioning element and their functions are described in fig. 18A-18G.

Referring to fig. 21C, in a first embodiment 2110C, a catheter 2102C includes an outer sheath 2104C and an inner catheter 2106C. Outer sheath 2104c includes a proximal end 2103c and a distal end 2105c having a soft atraumatic tip. The soft tip is configured to be soft and atraumatic to the vaginal cavity, the external cervical orifice, and the cervix during positioning. The inner catheter 2106c is coaxial with the outer sheath 2104c and has a diameter smaller than the diameter of the outer sheath 2104 c. At least one electrode 2108c is positioned within lumen 2115c of inner catheter 2106c. In other embodiments, the inner catheter includes at least one microwave antenna in place of at least one electrode. The electrode 2108c is coaxial with the inner catheter 2106c. In some embodiments, electrode 2108c extends along the entire length or nearly the entire length of inner catheter 2106c, as shown in illustration 2110 c. An electrical current is supplied to electrode 2108c to generate heat, thereby converting fluid flowing through electrode 2108c into steam. Referring to illustration 2110c, saline 2101c passing along the length of electrode 2108c converts into steam 2113c, which steam 2113c exits at least one inner catheter opening 2114c at the distal end of inner catheter 2106c and diffuses within space or gap 2107c between the outer surface of outer sheath lumen or inner catheter 2106c and the inner surface of outer sheath 2104 c. In some embodiments, inner conduit 2106c includes additional openings to allow steam 2113c to flow into space or gap 2107 c. The outer sheath 2104c is configured with one or more outer sheath openings 2116c through which steam exits the catheter 2102c to ablate endometrial tissue. In some embodiments, the length of the outer sheath 2104c is in the range of 0.50 to 3.50 inches. In embodiment 2110c, outer sheath 2104c has a length of 1.75 inches. In some embodiments, outer sheath 2104c is insulated such that the temperature of the steam generated by electrode 2108c is maintained as the steam exits openings 2114c and 2116 c. In some embodiments, the catheter includes a temperature sensor 2109c. In some embodiments, four temperature sensors 2109c are included in the space 2107c between the inner catheter and the outer sheath. In some embodiments, pressure sensor 2111c is included in the fluid path, e.g., in space 2107c between the inner catheter and the outer sheath.

The second embodiment 2112c is a catheter 2122c that includes an inner catheter 2120c, the inner catheter 2120c extending only partially into an outer sheath lumen or space or gap 2127c between the inner catheter 2120c and the outer sheath 2124 c. At least one electrode 2118c is positioned on lumen 2121c of inner catheter 2120 c. The outer sheath 2124c includes a plurality of openings 2126c in a portion of its distal length, while the inner catheter 2120c and electrode 2118c are positioned in a portion of its proximal length. In some embodiments, openings 2126c are equally spaced apart and spread out over the surface of outer sheath 2124c along a length in the range of 0.25 inch to 2.50 inches of the distal portion of outer sheath 2124 c. In some embodiments, openings 2126c are equally spaced apart and spread out over the surface of outer sheath 2124c along a length of 1.25 inches of the distal portion of outer sheath 2124 c. The inner catheter 2120c and electrode 2118c are positioned within 0.5 inches of the proximal portion of the outer sheath 2124 c. Saline 2127c passing along electrode 2118c is converted to vapor 2129c, which vapor 2129c enters space 2127c through inner sheath opening 2128c and exits through opening 2126c along the distal portion of outer sheath 2124c to ablate endometrial tissue. In some embodiments, the catheter includes a temperature sensor 2139c. In some embodiments, four temperature sensors 2139c are included in space 2127c between the inner catheter and the outer sheath. In some embodiments, pressure sensor 2131c is included in the fluid path, e.g., in space 2107c between the inner catheter and the outer sheath.

Fig. 21D shows a configuration similar to the first embodiment 2110C of fig. 21C, with a positioning element 2130D attached to a catheter 2102D. The positioning element 2130d has an elongated oval shape extending along the length of the outer sheath 2104 d. In an embodiment, the positioning element 2130d is a wire mesh with a first proximal end 2131d attached to the proximal end 2107d of the inner catheter 2106d and a second distal end 2133d of the positioning element 2130d attached to the distal end 2105d of the outer sheath 2104 d. The wire mesh allows sufficient space between the wires of the mesh for the vapor to escape. The positioning element 2130d functions similarly to the first and second positioning elements described with reference to the other endometrial ablation catheters of this specification. The first surface 2135d of the positioning element 2130d corresponding to the second distal end 2133d is configured to abut an upper interior surface of the uterus of the patient, while the second surface 2137d of the positioning element 2130d corresponding to the first proximal end 2131d is configured to abut an internal cervical os of the patient. In an embodiment, the wire mesh is made of nitinol or any other shape memory material such that the positioning element 2130D expands into a deployed configuration, as shown in fig. 21D. In an embodiment, the positioning element 2130d is made of a single wire mesh. In some embodiments, the positioning element 2130d is made of a two-wire mesh. Fluid or saline is delivered into inner conduit 2106 and is converted to steam as it passes along electrode 2108 d. Then, when the positioning element 2130d is in an expanded state and deployed within the uterus, steam is delivered from the outer sheath opening 2116 d. The outer sheath 2104d includes an atraumatic distal tip 2124d, in an embodiment, the atraumatic distal tip 2124d is also externally covered by a second distal end 2133d of the positioning element 2130d and attached to the second distal end 2133d of the positioning element 2130 d. FIG. 21D also shows an O-ring 2126D configured to slidably couple the proximal end 2103D of the outer sheath 2104D with the outer surface of the inner catheter 2106D. O-ring 2126d is configured to prevent vapor within space 2127d from exiting the catheter proximally back into the cervix. Figures 21F and 21G, described later, show details of the connection between the inner catheter and the outer sheath.

In an embodiment, after deployment, the electrode 2108d is positioned within the inner catheter 2106d over the O-ring 2126d and preferably covers the entire length of the inner catheter 2106d coaxially disposed within the outer sheath 2104 d. The saline passing through inner catheter 2106d is heated by electrode 2108d and converted to steam, which exits through inner catheter opening 2114d at the distal tip of inner catheter 2106d and further exits through outer sheath opening 2116d on the surface of outer sheath 2104 d. In some embodiments, openings 2114d and 2116d are circular, slotted, semi-circular, or any other shape. In some embodiments, 1 to 1000 openings 2116d are distributed over the length of the outer sheath 2104d, wherein each opening has a length or diameter in the range of 0.1 to 1 mm. In some embodiments, 64 to 96 openings are distributed over the length of the outer sheath 2104 d. In an embodiment, the distal tip of the outer sheath 2104d is enclosed within the positioning element 2130 d. In some embodiments, a silicone covering is provided to partially cover the surface of the wire mesh of positioning element 2130 d. Vapor from the opening 2116d escapes through the uncovered portion of the wire mesh of the positioning element 2130 d.

Fig. 21E illustrates a deployed configuration 2110E and a compressed configuration 2112E of a distal end of an ablation catheter 2102E having a positioning element 2130E, according to some embodiments of the present disclosure. The catheter 2102e includes an outer sheath 2104e, the outer sheath 2104e being slidably coupled at its proximal end to an outer surface of the inner catheter 2106e by an O-ring 2126 e. The positioning element 2130e includes two surfaces, a second proximal or bottom surface 2137e attached to the inner catheter 2106e, and a first distal or top surface 2135e attached to the distal end of the outer sheath 2104 e. Initially, prior to deployment of the positioning element 2130e (see construct 2112 e), the inner catheter 2106e has not been positioned within the outer sheath 2104e, and the positioning element 2130e is compressed about the outer sheath 2130 e. When deployed (see construct 2110 e), inner catheter 2106e is pulled coaxially into outer sheath 2104e and positioning element 2130e expands to fill the endometrial space. In some embodiments, the positioning element 2130e expands to form a spherical shape (also referred to as a bell or teardrop shape) having a first distal surface 2135e or "disc" that abuts the inner top surface of the uterus, and a second proximal surface 2137e or "disc" that abuts the inner cervical opening. The steam delivered through the openings in outer sheath 2104e travels through the wire mesh of positioning element 2130e, exits through the space in the mesh, and contacts endometrial tissue for ablation.

Fig. 21F illustrates an embodiment of a catheter 2102F in accordance with some embodiments of the present description, in which the positioning element 2130F is in its deployed configuration. The outer sheath 2104f is positioned within the positioning element 2130f and along the central longitudinal axis of the positioning element 2130 f. The outer sheath 2104f is configured with an opening and is described previously with reference to fig. 21C-21E. The positioning element 2130f is conical with a proximal end attached to an outer proximal surface of the outer sheath 2104 f. In some embodiments, the proximal end of the positioning element 2130f is crimped to attach with the outer surface of the outer sheath 2104 f. The first illustration 2110f shows a top view of the positioning element 2130f and the outer sheath 2104f centered therein. The second illustration 2112f shows a cross-sectional view of the positioning element 2130f and the outer sheath 2104f along a central longitudinal axis of the outer sheath 2104 f. A third illustration 2114f shows an enlarged view of the connection between the proximal end of the outer sheath 2014f and the catheter body 2102 f. Referring simultaneously to the three illustrations 2110f, 2112f and 2114f, the positioning element 2130f has a narrower proximal end that attaches to the proximal end of an inner catheter (not shown), and a distal rounded end having an annular shape with a maximum outer diameter in the range of 30.5mm to 33.5mm, an inner diameter of about 20mm, an average diameter of about 24mm and a length of about 8mm to 12 mm. The outer sheath 2104f has a diameter of about 1.7mm at its proximal end. At the distal end, positioning element 2104f has an atraumatic surface or soft tip configured to be soft and atraumatic to the vaginal cavity, the external cervical os, and the cervix during positioning. The proximal surface of the annular portion of the positioning element 2130f extends proximally in a tapered configuration. In some embodiments, the positioning element 2130f in a deployed, expanded configuration has a total length in a range of about 43 to 47 millimeters. In some embodiments, the angle formed by the taper of positioning element 2130f is about 26.4 °. The positioning element 2130f is made of wire mesh using a material such as nitinol. In some embodiments, silicone is used to cover a portion or all of the screen. The covered portion of the positioning element 2130f blocks vapor flow through the wire mesh and directs the flow out through the uncovered portion.

The illustration 2114f shows a cross-sectional detail of the connection between the proximal end of the outer sheath 2104f and the distal end of the catheter body 2102 f. The connection includes a first connector 2152f and a second connector 2154f. The first connector 2152f is positioned on the distal end of the catheter body 2102 f. In an embodiment, the first connector 2152f has a total length of 13.5 mm. The central portion has a greater outer thickness about the central lumen 2140f relative to the proximal and distal portions. In some embodiments, the proximal portion and the central portion each have a length of 5mm, and the distal portion has a length of 3.5 mm. The distal portion includes threads 2144f having a diameter M2. The catheter body 2102f has a diameter in the proximal portion in the range of about 0.95 to 1.05 mm. The thicker central portion of the first connector 2152f has a diameter of approximately 2.8 mm. The second connector 2154f is positioned at the distal end of the outer sheath 2104f and includes a cylindrical crimp 2146f. In an embodiment, the second connector 2154f has a length of about 8mm and an outer diameter of about 3.3 mm. In some embodiments, a proximal portion of the crimp 2146f that is approximately 3.2mm in length is disposed centrally within its cylindrical structure in the corrugated hollow 2148f to receive the threaded length 2144f of the first portion of the connector 2114 f. The remaining length 2150f of the crimp 2146f is configured to coaxially receive the outer sheath 2104f therein. In an embodiment, during operation, an inner catheter (not shown) is pulled through lumen 2140f, through hollow 2148f, and further within outer sheath 2104 f.

Fig. 21G illustrates a different three-dimensional view of a positioning element 2130G (corresponding to positioning element 2130 f) and a connector 2114G including a first connector 2141G and a second connector 2146G in their deployed configuration according to some embodiments of the specification. The first illustration 2110g shows a bottom and side perspective view of the positioning element 2130g and the connector 2114 g. Also shown is an exploded view of the elements depicting the connector 2114 g. The illustration 2112g shows a top and side perspective view of the positioning element 2130g and the connector 2114 g. The first connector 2141g includes a lumen 2140g and includes three portions. The proximal-most portion 2140g is in an elongate cylindrical configuration and provides access for an inner catheter through the connector 2114g into an outer sheath (not shown) within the positioning element 2130 g. The medial portion 2142g has a thicker diameter than the proximal-most portion of the lumen 2140 g. The distal portion 2144g of the first portion of the connector 2114g has a threaded surface to enable a threaded connection with the hollow 2148g inside the second connector 2146g of the connector 2114 g. The second connector 2146g provides a crimp configured to crimp around and secure the proximal end of the outer sheath.

Fig. 21H illustrates a different view of another embodiment of a positioning element 2130H in its deployed configuration according to some embodiments of the present description. The first illustration 2110h shows a side view of the positioning element 2130 h. The second illustration 2112h shows a top and side perspective view of the positioning element 2130 h. The third illustration 2114h shows another perspective view of the positioning element 2130 h. The positioning element 2130h includes a proximal first portion 2132h, a medial second portion 2134h, and a distal third portion 2136h. The proximal first portion 2132h has a conical shape with a diameter that increases as the proximal first portion 2132h extends from the proximal end of the positioning element 2130h to the proximal end of the intermediate second portion 2134 h. In an embodiment, the proximal first portion 2132 has a length of about 20mm and a taper angle of about 60 ° toward the intermediate second portion 2134 h. The intermediate second portion 2134h extends continuously from the distal end of the proximal first portion 2132h in a cylindrical form for a length, in some embodiments, in the range of 28mm to 32 mm. In some embodiments, the diameter of the intermediate second portion 2134h is in the range of 22.5 to 25.5 mm. The distal third portion 2136h includes an annular shape and extends distally from the distal end of the second intermediate portion 2134 h. In some embodiments, the distal third portion has a length of about 8 mm. The diameter of the distal third portion 2136h is greater than the diameter of the intermediate second portion 2134 h. In some embodiments, distal third portion 3136h includes an outer spherical surface covering a maximum diameter in the range of 30.5mm to 33.5 mm. The inner circular surface of the distal third portion 3136h is planar. In an embodiment, the positioning element 2130h comprises a nitinol mesh. In some embodiments, the mesh is partially covered with a silicone material to prevent vapor from migrating out of the positioning element at the covered portion. In some embodiments, the wall of the entire positioning element 2130h is made of a nitinol wire mesh covered with a silicone material with its distal circular end open to enable vapor to exit for ablation. The connector 2146h is included at the proximal end and functions similarly to the second connector 2146G of fig. 21G.

FIG. 21I illustrates coaxial telescoping movement of inner catheter 2106I within outer sheath 2104I when positioning element 2130I is deployed to a fully expanded configuration according to some embodiments of the present specification. The arrows shown within the inner catheter 2106i illustrate the direction of coaxial telescoping movement of the inner catheter 2106i within the outer sheath 2104i toward the distal end of the positioning element 2130i when the positioning element 2130i is deployed to a fully expanded configuration. When the positioning element 2130i is compressed and the inner catheter 2106i is retracted to the delivery configuration, the direction of coaxial telescoping movement of the inner catheter 2106i within the outer sheath 2104i is toward the connector 2146i. Referring simultaneously to fig. 21E and 21I, the distal end of the catheter 2102E is advanced into the uterus of the patient while in the compressed configuration shown in fig. 2112E. The inner conduits 2106E, 2106I are then coaxially advanced into the outer sheaths 2104E, 2104I, expanding the positioning elements and resulting in the fully deployed configuration shown in fig. 21E, 2110E and 21I.

Fig. 21J illustrates a system for ablating endometrial tissue, according to some embodiments of the present disclosure. The system is configured to use a catheter having a distal end with a single positioning element, as described with reference to fig. 21C-21I. The ablation system 2100j includes a catheter 2101j, and in some embodiments, the catheter 2101j includes a handle 2190j, the handle 2190j having actuators 2191j, 2192j, 2193j for advancing an inner catheter 2106j within an outer sheath 2104j and deploying a positioning element 2130j at a distal end of the catheter 2101 j. At least one electrode 2113j is positioned within the inner catheter. In some embodiments, the electrodes are replaced with microwave antennas . In an embodiment, the positioning element 2130j is expandable, positioned at the distal end of the catheter 2101j, and may be compressed within the outer sheath 2104j for delivery. In some embodiments, the actuators 2192j and 2193j comprise knobs. In some embodiments, the actuator/knob 2192j is used to extend the inner catheter 2106j into the outer sheath 2104j and deploy the positioning element 2130j. For example, in an embodiment, the actuator/knob 2192j is rotated a quarter turn to extend the inner catheter 2106j into the outer sheath 2104j and deploy the positioning element 2130j. In other embodiments, other combinations of actuators/knobs are used to extend the inner catheter 2106j into/retract the outer sheath 2104j from the outer sheath 2104j and deploy/compress the positioning element 2130j. In some embodiments, the catheter 2101j includes a port 2103j for delivering a fluid (e.g., cooling fluid) during ablation. In some embodiments, port 2103j is also configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, port 2103j is positioned on handle 2190 j. Electrode 2113j is configured to receive current supplied by connection line 2111j extending from controller 2115j to conduit 2101j to heat and convert fluid, such as saline supplied via conduit 2112j extending from controller 2115j to conduit 2101 j. The heated fluid or saline is converted to steam or vapor for delivery through ports along the outer sheath for ablation. In some embodiments, the catheter 2101j is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. The delivery of the ablative agent is controlled by controller 2115j and the treatment is controlled by the treating physician via controller 2115 j.

Fig. 21K is a flowchart showing steps involved in ablating a patient's endometrium using an ablation catheter according to embodiments of the present disclosure. At step 2102k, the atraumatic tip of the outer sheath of the ablation catheter is advanced through the cervix and into the uterus of the patient. At step 2104k, the inner catheter of the ablation catheter is extended into the outer sheath using the actuator, which causes the compressed positioning element to expand and fill the uterus. At step 2106k, current is supplied to at least one electrode positioned within the inner catheter. At step 2108k, saline is delivered into the inner catheter and along the at least one electrode, wherein the saline is converted to steam and enters the outer sheath through the openings in the inner catheter, and then the saline exits to the uterus via the plurality of openings in the outer sheath to ablate endometrial tissue.

Ablation of bladder cancer and treatment of OAB

Fig. 22B shows a system 2200B for ablating bladder tissue, according to an embodiment of the present disclosure. System 2200b includes a catheter 2230, and in some embodiments, catheter 2230 includes a handle 2232 having actuators 2234, 2236, with actuators 2234, 2236 for pushing forward a distal tip 2238 of catheter 2230 and for deploying distal positioning element 2240 at a distal end of catheter 2230. In an embodiment, conduit 2230 includes an outer sheath 2242 and an inner catheter 2244. In an embodiment, the distal positioning element 2240 is expandable, positioned at the distal end of the inner catheter 2244, and may be compressed within the outer sheath 2242 for delivery. In some embodiments, actuators 2234 and 2236 comprise knobs. In some embodiments, actuator/knob 2236 is used to deploy distal positioning element 2240. For example, in an embodiment, actuator/knob 2236 is rotated a quarter turn to deploy distal positioning element 2240. In some embodiments, other combinations of actuators/knobs are used to position element 2240. In some embodiments, conduit 2230 includes ports 2246 for delivering a fluid (e.g., a cooling fluid) during ablation. In some embodiments, port 2246 is also configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, port 2246 is positioned on handle 2232. In some embodiments, at least one electrode 2248 is positioned at the distal end of catheter 2230. Electrode 2248 is configured to receive current supplied by connection line 2250 extending from controller 2252 to conduit 2230 to heat and divert fluid, such as brine supplied via conduit 2254 extending from controller 2252 to conduit 2230. The heated fluid or saline is converted to steam or vapor for delivery through the port for ablation. In some embodiments, catheter 2230 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. Multiple small delivery ports are distally locatedOn the inner conduit 2244 between the element 2240 and the electrode 2248. The port is for injecting an ablative agent, such as steam. Delivery of the ablative agent is controlled by controller 2252 and treatment is controlled by the treating physician via controller 2252. In an embodiment, the system 2200B of fig. 22B is configured for ablation of the bladder and may be used with catheters, positioning elements, and needles described later in the context of fig. 23-28.

Fig. 23 illustrates an exemplary catheter 2302 for insertion into a bladder 2304 to ablate bladder cancer 2306 according to some embodiments of the present description. Exemplary embodiments of the distal end of catheter 2302 are shown in the context of fig. 18V, 18W, and 18X. The distal end 2308 of the catheter 2302 is advanced through the urethra 2310 and into the bladder 2304. Cystoscopes may be used to advance the catheter, or in some embodiments, provide visualization capabilities in the catheter to navigate the catheter. A positioning element 2312 attached to the distal end 2308 of the catheter 2302 is used to position the ablation catheter 2302 within the bladder 2304. In some embodiments, positioning element 2312 comprises a plurality of wires woven in a pattern (e.g., a spiral pattern). In an embodiment, the wire is constructed of a shape memory material to allow compression of the positioning element 2312 during delivery. In some embodiments, the shape memory material is nitinol. In various embodiments, the positioning element 2312 has a disk shape, a cone shape, a funnel shape, a bell shape, a sphere shape, an ellipse shape, an oval shape, or an acorn shape, and is substantially cylindrical when compressed. When deployed, the positioning element 2312 abuts and rests in the balloon 2304, the balloon 2304 surrounding a portion of tissue to be ablated.

24A, 24B and 24C illustrate different views of an exemplary configuration of a distal end of a catheter 2402 having a positioning element 2412 according to some embodiments of the present disclosure. Fig. 24A shows a front end view of the positioning element 2412. Fig. 24B shows a side view of the catheter 2402 and the positioning element 2412. Fig. 24C shows a front perspective view of the catheter 2402 and the positioning element 2412. 24A, 24B and 24C, the positioning element 2412 has a pyramid shape with four sides, providing an open square form at its distal end. In some embodiments, the positioning element 2412 has a length and width at its open distal end in the range of 13mm to 17 mm. The catheter 2402 is attached at its distal end 2408 to a positioning element 2412. Conduit 2402 includes an outer conduit 2418 and an inner conduit 2420. In an embodiment, the positioning element 2402 is attached to the distal end 2408 of the outer catheter 2418 by a connection mechanism. Inner catheter 2420 is positioned within outer catheter 2418 and coaxial with outer catheter 2418. A steam port 2416 is configured on the inner catheter 2420 that provides an outlet for steam 2314 (fig. 23) during ablation.

25A, 25B and 25C illustrate designs of the positioning element 2512 according to some embodiments of the present disclosure. Fig. 25A illustrates a close-up view of connection 2520 between positioning element 2512 and catheter 2502 according to some embodiments of the present description. In an alternative embodiment, the positioning element 2512 is fused to the catheter 2502, free floating with a metal or polymer suture, hinged with laser welded nitinol, wherein the hinge is cut with a laser, or attached with a nitinol sleeve welded thereto. In some embodiments, the connector 2520 is part of the distal end 2508 of the cannula or catheter 2502. Fig. 25B shows a side view of the positioning element 2512 attached to the distal end 2508 of the catheter 2502. One or more vapor ports 2516 are configured on an inner catheter 2520 within an outer catheter 2518 at the distal end of catheter 2502, wherein the distal portion of catheter 2502 is located within the funnel-shaped volume of positioning element 2512. In an embodiment, inner catheter 2520 can be moved into and out of outer catheter 2518 such that outer catheter 2518 covers inner catheter 2520 and constrains positioning element 2512 prior to insertion into the patient's urethra. Positioning element 2512 is constructed of a shape memory material such that once inner catheter 2520 extends beyond the distal end of outer catheter 2518, positioning element 2512 expands to a deployed configuration, as shown in fig. 25A. Fig. 25C illustrates different types of configurations of positioning elements 2513 that may be used in accordance with embodiments of the present disclosure. In some embodiments, the positioning element is conical in shape, varying from 5mm to 50mm in diameter. In some embodiments, the positioning element is an oval cone, wherein a first proximal diameter of the cone is smaller than a second distal diameter of the cone to approximate the shape or size of the urethra. In various embodiments having a plurality of positioning elements, the first positioning element may have a different shape or size than the second positioning element. One or more positioning elements may be used for therapeutic purposes.

In some embodiments, the positioning element 2512 is formed from a wire made from one or a combination of a polymer and a metal, including, for example, but not limited to, polyetheretherketone (PEEK) and nickel titanium (NiTi). In some embodiments, the wires are covered with an elastomer, such as PTFE, ePTFE, PU and/or silicone, in various patterns. The various units in the positioning element 2513 may be covered or uncovered based on the hood function, such as whether it is used for sealing or for ventilation or for any other purpose. In embodiments where the positioning element 2513 is made of nitinol wire mesh, the wire diameter is in the range of 0.16 to 0.18 mm. In some embodiments, for positioning element 2513, the wire mesh is coated with silicone, but the areas between the wires in the mesh are not coated, thus allowing vapor to escape/escape from these spaces between the wires. In some embodiments, the wires and the spaces between the wires are covered with silicone.

Embodiments of the present disclosure may also be used to ablate bladder neck tissue and/or internal sphincter muscle to treat OAB, as described with reference to the subsequent embodiments of fig. 26A and 26B. OAB is associated with sudden, uncontrolled urination demands or impulses. OAB differs from Stress Urinary Incontinence (SUI) in that people leak urine when sneezing, laughing, or performing other physical activities. OAB may be caused by improper coordination of nerve signals between the bladder and brain. Even when the bladder is not full, the signal may tell the patient to empty the bladder. OAB may also be caused when muscles in the bladder are too active. In this case, the bladder muscle contracts to pass urine before the bladder fills, resulting in a sudden urge to urinate. Treatment of the bladder neck and/or internal sphincter with the ablative methods of this specification provides a method of treating OAB. Thus, steam is selectively delivered to ablate the deep detrusor and the nerve-rich layer of the adventitial space below the triangle. Alternatively, steam is selectively delivered with the aid of an RF generator to ablate the bladder neck, internal Urethral Sphincter (IUS), and nerves supplying the IUS. The RF generator provides power to electrodes in a heating chamber within the guide tube. When fluid flows through the space in the heating chamber and power is applied to the electrodes, the electrodes are charged, which heats the brine by brine conduction, resistance and evaporates the water in the brine. Thermal energy remodels the tissue, resulting in improved barrier function and less random relaxation leading to incontinence caused by OABs.

Fig. 26A illustrates the positioning of a needle ablation catheter 2602 for delivering steam to selectively ablate the nerve-rich layer of the deep detrusor and the adventitial space below triangle 2622 in accordance with an embodiment of the present specification. Fig. 26B illustrates the positioning of a needle ablation device for delivering steam to selectively ablate the bladder neck, IUS, and nerves supplying IUS2624 and bladder neck in accordance with an embodiment of the present disclosure. 26A and 26B, one or more needles 2626 are used to deliver steam to the target zone 2622 or 2624. In an embodiment, the sensor probe is used to measure one or more parameters to control ablation. In one embodiment, the sensor probe may be positioned at the distal end of a heating chamber within the catheter. During steam generation, the sensor probe transmits a signal to the controller. The controller may use the signal to determine whether the fluid has completely evolved into steam before exiting the distal end of the heating chamber. Sensing whether saline has been completely converted to steam may be particularly useful for many surgical applications, such as in ablation of various tissues, where delivering high quality (low water content) steam results in more effective treatment.

The ablation system of fig. 26A and 26B includes a catheter 2602 having an internal heating chamber disposed within a lumen of the catheter and configured to heat fluid provided to the catheter 2602 to change the fluid to steam for ablation therapy. In some embodiments, the catheter 2602 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. A plurality of openings are located near the distal end of the catheter 2602 for enabling a plurality of associated thermally conductive elements (e.g., pins 2626) to extend (from the catheter 2602 at an angle, wherein the angle ranges between 30 and 180 degrees) and be deployed or retracted through the plurality of openings. According to one aspect, the plurality of retractable needles 2626 are hollow and include at least one injection port to allow for delivery of an ablative agent, such as steam or vapor, through the needles 2626 as the needles 2626 are extended and deployed through the plurality of openings in the elongate body of the catheter 2602. In some embodiments, the infusion port is positioned along the length of needle 2626. In some embodiments, the infusion port is positioned at the distal tip of needle 2626. In various embodiments, a tension wire attached to the needle is used to control the shape and position of the needle to help puncture the bladder wall. In some embodiments, steam is applied to the trigone through a needle, thereby ablating nerves in the trigone to prevent or treat OAB.

Fig. 27A illustrates a different view of a coaxial needle 2726 that may be used for ablation to treat OAB according to some embodiments of the present description. The figure shows a cross section of a side view 2730, a front side perspective 2732, and a side view 2734 of needle 2726. In some embodiments, needle 2726 includes two concentric tubes with lumens—an inner tube 2736 within an outer tube 2738. Needle 2726 is cut diagonally at its sharp distal end such that in one embodiment the length of the needle extending to its sharp distal end is about 1mm and the length extending to its proximal distal end is about 0.885mm. The inner tube 2736 includes a first lumen to provide a channel for venting steam for ablation. In one embodiment, the gap between inner tube 2736 and outer tube 2738 is about 0.007mm. Inner tube 2736 and outer tube 2738 are welded together at the distal end of needle 2726 by about 0.151mm and at the proximal end of needle 2726 by about 0.10mm. Steam generated in the catheter travels through one or more needles 2726 connected to one or more openings of the catheter, enters needle 2726 from the hollow of inner tube 2736 proximal of needle 2726, and exits distal of needle 2726. Fig. 27B illustrates a distal end of a coaxial needle 2726 that includes an inner tube 2736 with a lumen and an outer tube 2738 with a lumen, according to some embodiments of the present disclosure. In some embodiments, the gap between the inner tube 2736 with lumen and the outer tube 2738 with lumen is filled with air or a fluid for insulation. In some embodiments, the gap may be irrigated and may be used for aspiration.

Fig. 28 is a flowchart illustrating an exemplary process of ablating a bladder and/or its peripheral area according to some embodiments of the present description. The ablation system described in the context of the various figures above is used to ablate a target area within or near the bladder of a patient.The target area may include tissue within the bladder, cysts, stage 1 to 8 tumors, in order to treat cancerous growth. The target area may also include the deep detrusor and the nerve-rich layer of the adventitial space below the triangle, as well as the bladder neck, the IUS, and the nerves supplying the IUS and bladder neck. According to the present description, at step 2802, liquid (urine) is drained from the bladder. The bladder is emptied to empty the bladder so that urine is not expected to wet or collect on or around the target area. The target area is drained to ensure that a large amount of urine is removed for effective ablation. In some embodiments, urine is removed from the bladder. In some embodiments, additionally, air or CO ₂ Into the bladder to expand the bladder. Air is used to dry the inner surface of the bladder prior to ablation. In some embodiments, additionally, by making the target portion of the bladder independent, the patient is positioned to use gravity to drain any residual urine from the target portion of the bladder. At step 2804, a catheter of an ablation system is inserted into the bladder. At step 2806, a positioning element (e.g., positioning element 2312 of fig. 23) is deployed adjacent to the target area so as to encompass a portion or all of the target area to be ablated. Alternatively, a thermally conductive element (e.g., one or more needles 2626 of fig. 26A and 26B) is deployed to access peripheral regions of the bladder, including but not limited to the patient's triangle and the region under the IUS or the patient's prostate. At step 2808, steam is delivered to the target area to ablate the target area. In an embodiment, during ablation, the pressure within the balloon is maintained at a level below 5 atm.

Imaging capability

Imaging capability may be added to ablation systems for Benign Prostatic Hyperplasia (BPH), abnormal Uterine Bleeding (AUB), overactive bladder (OAB), and for any of the other tissue ablation procedures described in the embodiments of the present specification. In embodiments, the imaging capability is provided in the form of an integrated optical chip with an ablation system, or as a coaxial fiber optic line with a sheath of a catheter of the ablation system.

Fig. 29 illustrates a system 29100 for prostate tissue ablation and imaging according to an embodiment of the present disclosure. The system 29100 includes a catheter 29102, and in some embodiments, the catheter 29102 includes a handle 29104 having actuators 29106, 29108 for extending at least one needle or needles 29110 from the distal end of the catheter 29112 and expanding the positioning element 29114 at the distal end of the catheter 29112. In some embodiments, actuators 29106 and 29108 may be one of a knob or slider or any other type of switch or button to enable at least one needle to extend from multiple needles 29110. The delivery of steam via conduit 29102 is controlled by controller 29116. In an embodiment, the catheter 29102 includes an outer sheath 29118 and an inner catheter 29120. Needle 29110 extends from inner catheter 29120 at the distal end of sheath 29118, or in some embodiments, through an opening near the distal end of sheath 29118. In an embodiment, the positioning element 29114 is expandable, positioned at the distal end of the inner catheter 29120, and may be compressed within the outer sheath 29118 for delivery. In some embodiments, actuator 29108 includes a knob that is rotated a first degree, e.g., a quarter turn, to retract outer sheath 29118. When the outer sheath 29118 is retracted, the positioning element 29114 is exposed. In an embodiment, the positioning element 29114 comprises a disc or cone configured as a bladder anchor. In an embodiment, actuator/knob 29108 is rotated a second extension, e.g., a second quarter turn, to further retract outer sheath 29118 to deploy needle 29110. In some embodiments, referring to fig. 29, 4C and 4E simultaneously, needles 29110, 3116a are deployed from the lumens of inner catheters 29120, 3111a through slots or openings 3115a in outer sheaths 29118, 3110a, which helps control needle path and isolate the urethra from vapors. In some embodiments, the opening is covered with a slit cover 3119. In another embodiment, for example, as shown in fig. 4D, sleeve 3116b naturally folds outwardly when outer sheath 3110b is pulled back.

Referring again to fig. 29, in some embodiments, the catheter 29102 includes a port 29122 for delivering a fluid (e.g., cooling fluid) during ablation. In some embodiments, the port 29122 is further configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, port 29122 for fluid flushing and for vapor generation and pumping. In some embodiments, the port 29122 is positioned on the handle 29104. In some embodiments, at least one electrode 29124 is positioned at the distal end of catheter 29102 proximal to needle 29110. The electrode 29124 is configured to receive current supplied by the connection 29128 extending from the controller 29116 to the conduit 29102 to heat and convert a fluid, such as saline supplied via the conduit 29126 extending from the controller 29116 to the conduit 29102. The heated fluid or saline is converted to steam or vapor for delivery by needle 29110 for ablation.

In an embodiment, imaging capabilities are integrated with the system 29100. In some embodiments, the sheath 29118 includes optical fibers connected to the fiber optic light source 29134 to illuminate the channel at the distal end of the catheter 29102. In some embodiments, the sheath 29128 is disposed parallel to the outer sheath 29118, wherein the sheath 29128 comprises an optical fiber or comprises an optical chip. In some embodiments, sheath 29128 is coaxial with outer sheath 29118, parallel to inner sheath 29120. In some embodiments, the catheter 29102 is a multi-lumen catheter, with one lumen for the camera and electronics (sheath 29128). Sheath 29128 may be made of a material such as polyurethane or thermoplastic polymer. In some embodiments, system 29100 includes an integrated optical circuit (IC) mounted within system 29100. Fig. 11O illustrates and describes details of an embodiment of a viewing device that may be integrated with the catheter 29102, according to some embodiments. The IC may be part of conduit 29102, either in generator 29116 or in a third party computing device in communication with system 29100. Eyepiece 29130 is integrated into handle 29104. Eyepiece 29130 enables a user (e.g., a physician) to view the passage of catheter 29102 captured by an optical system (fiber optics, integrated optical circuit). In some embodiments, video of the image captured by the optical system is transmitted to a display, such as a screen of a computer or telephone, using video correction cable 29132. Buttons or interactive interfaces or triggers are provided in the generator 29116 or with a third party computing device in communication with the system 29100, which enable control of the capture of still and video images.

Fig. 30 illustrates a system for endometrial tissue ablation according to an embodiment of the disclosure30100. The ablation system 30100 includes a catheter 30102, and in some embodiments, the catheter 30102 includes a handle 30104 having actuators 30106, 30108, 30110, the actuators 30106, 30108, 30110 for pushing the distal spherical tip of the catheter 30102 forward and for deploying the first distal positioning element 30114 and the second proximal positioning element 30116 at the distal end of the catheter 30102. In an embodiment, the catheter 30102 includes an outer sheath 30118 and an inner catheter 30120. In an embodiment, the catheter 30102 includes a cervical collar 30122, the cervical collar 30122 being configured to rest against the external port once the catheter 30102 has been inserted into the uterus of the patient. In an embodiment, the distal first positioning element 30114 and the proximal second positioning element 30116 are expandable, positioned at the distal end of the inner catheter 30120, and may be compressed within the outer sheath 30118 for delivery. In some embodiments, actuators 30108 and 30110 comprise knobs. In some embodiments, the actuator/knob 30108 is used to deploy the distal first positioning element 30114. For example, in an embodiment, the actuator/knob 30108 rotates a quarter turn to deploy the distal first positioning element 30114. In some embodiments, the actuator/knob 30110 is used to deploy the proximal second positioning element 30116. For example, in an embodiment, the actuator/knob 30110 is rotated a quarter turn to deploy the proximal second positioning element 30116. In some embodiments, the handle 30104 includes only one actuator/knob 30108 that rotates a first quarter turn to deploy the first distal positioning element 30114 and then rotates a second quarter turn to deploy the second proximal positioning element 30116. In other embodiments, other combinations of actuators/knobs are used to deploy one or both of the first distal positioning element 30114 and the second proximal positioning element 30116. In some embodiments, the catheter 30102 includes ports 30124 for delivering a fluid (e.g., cooling fluid) during ablation. In some embodiments, the ports 30124 are also configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, the ports 30124 are used for fluid flushing and for vapor generation or aspiration. In some embodiments, the ports 30124 are positioned on the handle 30104. In some embodiments, at least one electrode 30126 is positioned at catheter 30102 near the distal end of the proximal second positioning element 30116. The electrodes 30126 are configured to receive electrical current supplied by a connection line 30128 extending from the controller 30130 to the conduit 30102 to heat and convert a fluid, such as saline supplied via a tube 30132 extending from the controller 30130 to the conduit 30102. The heated fluid or saline is converted to steam or vapor for delivery through the ports 30134 for ablation. In some embodiments, the catheter 30102 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. A plurality of small delivery ports 30134 are located on the inner catheter 30120 between the distal first and second proximally located elements 30114, 30116. The ports 30134 are used to inject an ablative agent, such as steam. The delivery of the ablative agent is controlled by the controller 30130 and the treatment is controlled by the treating physician via the controller 30130.

In an embodiment, imaging capabilities are integrated with the system 30100. In some embodiments, sheath 30118 includes optical fibers connected to a fiber optic light source 30138 to illuminate a channel at the distal end of catheter 30102. In some embodiments, sheath 30136 is disposed parallel to outer sheath 30118, wherein sheath 30136 comprises an optical fiber or comprises an optical chip. In some embodiments, system 30100 includes integrated optical circuits mounted within system 30100. Fig. 11O illustrates and describes details of an embodiment of a viewing device that may be integrated with the catheter 29102, according to some embodiments. Eyepiece 30140 is integrated into handle 30104. Eyepiece 30140 enables a user (e.g., a physician) to view the passage of catheter 30102 captured by an optical system (fiber optics, integrated optical circuit). In some embodiments, video of the image captured by the optical system is transmitted to a display, such as a screen of a computer or telephone, using a video correction cable 30142.

Fig. 31 illustrates a system 31100 for ablating bladder tissue according to an embodiment of the present disclosure. The ablation system 31100 includes a catheter 31102, and in some embodiments, the catheter 31102 includes a handle 3104 having actuators 31106, 31108, the actuators 31106, 31108 for pushing forward a distal tip of the catheter 31102 and for deploying a distal positioning element 31112 at a distal end of the catheter 31102. In an embodiment, catheter 31102 includes an outer sheath 31114 and an inner guideTube 31116. In an embodiment, the distal positioning element 31112 is expandable, positioned at the distal end of the inner catheter 31116, and may be compressed within the outer sheath 31114 for delivery. In an embodiment, the positioning element 31112 includes a disk or cone configured as a bladder anchor. In some embodiments, actuators 31106 and 31108 comprise knobs. In some embodiments, the actuator/knob 31108 is used to deploy the distal positioning element 31112. For example, in an embodiment, actuator/knob 31108 is rotated a quarter turn to deploy distally-located element 31112. In other embodiments, other combinations of actuators/knobs are used to deploy the first positioning element 31112. In some embodiments, the catheter 31102 includes a port 31118 for delivering a fluid (e.g., cooling fluid) during ablation. In some embodiments, the port 31118 is further configured for providing fluid collection, providing vacuum, and providing CO ₂ For integrity testing. In some embodiments, port 31118 is for fluid flushing and for vapor generation. In some embodiments, the port 31118 is positioned on the handle 31104. In some embodiments, at least one electrode 31120 is positioned at the distal end of the catheter 31102. The electrode 31120 is configured to receive an electrical current supplied by a connection line 31122 extending from the controller 31124 to the conduit 31102 to heat and convert a fluid, such as saline supplied via a conduit 31126 extending from the controller 31124 to the conduit 31102. The heated fluid or saline is converted to steam or vapor for delivery through the port and/or needle for ablation. In some embodiments, the catheter 31102 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. The delivery of the ablative agent is controlled by controller 31124 and the treatment is controlled by the treating physician via controller 31124.

In an embodiment, imaging capabilities are integrated with system 31100. In some embodiments, sheath 31114 includes optical fibers connected to a fiber optic light source 31126 to illuminate a channel at the distal end of catheter 31102. In some embodiments, the jacket 31128 is disposed parallel to the outer jacket 31114, with the jacket 31128 comprising an optical fiber or comprising an optical chip. Fig. 11O illustrates and describes details of an embodiment of a viewing device that may be integrated with the catheter 29102, according to some embodiments. In some embodiments, system 31100 includes an integrated optical circuit mounted within system 31100. Eyepiece 31130 is integrated within handle 31104. Eyepiece 31130 enables a user (e.g., physician) to view the passage of catheter 31102 captured by an optical system (fiber optics, integrated optical circuit). In some embodiments, video of the image captured by the optical system is transmitted to a display, such as a screen of a computer or telephone, using video correction cable 31132.

Fig. 32 illustrates various components of an optical/viewing system 3200 for direct visualization that may be used in accordance with embodiments of the present disclosure. In an embodiment, the system 3200 includes an ablation catheter 3202, the ablation catheter 3202 being configured to deliver an ablation fluid to a volume of prostate tissue or a volume of fibrous tissue. Ablation catheter 3202 provides direct visualization that enables optical capture of the movement and/or position of a needle for prostate or fibrotic treatment. Direct visualization is achieved using an optical system comprising a camera and a light source, integrated into the same catheter comprising a needle and a heating means for steam generation. In an embodiment, the catheter comprises an ablation member and a viewing and illumination member in the form of a camera and a light source to enable viewing of the target area during ablation. Catheter 3202 includes a channel or sheath 3205 having at least one first lumen 3220, the at least one first lumen 3220 configured to receive a volume of fluid, such as saline, from a fluid reservoir or source 3128. At least one needle 3204 is positioned at a distal end 3203 of catheter 3202 and is configured to be deployed from a surface of distal tip 3207 of catheter 3202. The at least one needle 3204 includes at least one port 3209 for delivering an ablative agent. In an embodiment, at least one needle 3204 is configured to be deployed at an angle relative to a longitudinal axis 3229 defining a direction of distal tip 3207. In an embodiment, the angle is in the range of 10 degrees to 90 degrees relative to a longitudinal axis 3229 defining the direction of the distal tip 3207. At least one heating member 3211 is positioned within first lumen 3220 proximate distal tip 3207. In some embodiments, at least one heating component 3211 includes an electrode. In some embodiments, the electrode is a flat electrode. In some embodiments, the electrode has a tapered configuration such that the distal tip of the electrode is thinner than the proximal portion of the electrode. Handle 3206 is coupled to proximal end 3201 of sheath 3205. In an embodiment, handle 3206 is configured to enable an operator to deploy and retract at least one needle 3204 from distal end 3207 of catheter 3202 into distal end 3207 of catheter 3202.

The catheter also includes a camera 3230 at the distal tip 3207. In an embodiment, camera 3230 is configured to visually capture movement and position of at least one needle 3204 as needle 3204 protrudes from a surface of distal tip 3207. A light source 3232 is positioned adjacent to the camera 3230 and is configured to illuminate a target tissue region and to facilitate visualization via the camera 3230. In an embodiment, the camera 3230 and the light source 3232 are physically coupled into the sheath 3205. In some embodiments, second lumen 3221 is positioned within sheath 3205 and extends parallel to first lumen 3220. In some embodiments, camera 3230 and light source 3232 are positioned within distal end 3223 of second lumen 3221. Catheter 3204 also includes optical data transmission circuitry 3235 coupled to camera 3230. In an embodiment, the optical data transmission circuit 3235 is configured to transmit visual data captured by the camera 3230 to the controller 3212, wherein the controller 3212 includes a processor 3213, the processor 3213 being configured to process the visual data and present a visual image to an operator on the display device 3214. In some embodiments, optical data transmission circuit 3235 is positioned within second lumen 3221. In some embodiments, second lumen 3221 has a diameter of less than or equal to 4mm and first lumen 3220 has a diameter of less than or equal to 4 mm. The stylet 3222 is formed at the distal tip 3207 of the catheter 3204 by the combined presence of the needle 3204, the camera 3230 and the light source 3232. In an embodiment, ablation catheter 3202 has a diameter of 8mm or less, preferably 7mm or less, preferably 6mm or less, and most preferably in the range of 4mm to 5 mm.

The ablation catheter 3202 is maneuvered by a physician using controls disposed on the sheath 3206 that are coupled to the proximal end 3202 of the sheath 3205. In an embodiment, handle 3206 is a multi-function handle that connects first lumen 3220 of ablation catheter 3202 with fluid source 3218 via connecting tube 3216, which connecting tube 3216 provides the fluid or saline to be converted to steam for ablation. The connecting tube 3216 is in fluid communication with a fluid source or reservoir 3218 to provide fluid to the first lumen 3220. In embodiments, the fluid is brine. The fluid source or reservoir 3218 is in pressure communication with a pump 3219, the pump 3219 being coupled to the controller 3212. In an embodiment, the controller 3212 is in electrical communication with the at least one heating component 3211 and is programmed to deliver electrical current to the heating component 3211 and, when activated, to cause a volume of fluid from the fluid reservoir 3218 to enter the first lumen 3220 by controlling the pump. The fluid passing through heating component 3211 is converted to steam and delivered via at least one port 3209 of needle 3204 to ablate the target tissue. In an embodiment, the controller 3212 is programmed to deliver current to the at least one heating element 3211 in a continuous period of time less than or equal to one minute. In an embodiment, the controller 3212 further includes a power source 3215 located therein and coupled to the camera 3230 and the light source 3232. The power source 3215 is configured to provide power to the camera 3230 and the light source 3232.

The distal end 3207 of catheter 3202 includes a "stylet" 3222 including a distal end of needle 3204 and first lumen 3220, a camera 3230, and a light source 3232. In some embodiments, the light source 3232 comprises at least one LED lamp. As needle 3204 deploys from distal tip 3207 of catheter 3202, camera 3230 captures an image of the movement and position of needle 3204. The ability to directly capture images of needle movement and position during ablation procedures is particularly useful for prostate and fibrotic treatment. Conventional approaches require the use of an additional mirror (scope) separate and distinct from the ablation catheter to achieve visualization. However, the use of a separate mirror can create greater complexity to the procedure, making it difficult for a single operator to perform the procedure, and increasing the overall cost. Embodiments of the present description avoid the need for a separate mirror (e.g., endoscope) for visualization of the treatment. A close-up view 3227 and a front end view 3226 of a stylet 3222 or distal tip 3207 of catheter 3202 show at least one needle 3204 and camera 3230 positioned together surrounded by a light source 3232. Referring to close-up view 3227, arrow 3224 points to a location where at least one heating component is positioned for fluid or brine to steam generation. The optical data transmission circuit 3235 is in electrical communication with the controller 3212 via electrical wires 3217. In some embodiments, the wires include buttons, switches, or any other type of interface 3210 that enable a user to control the intensity of light emitted by the light source 3232. In other embodiments, handle 3206 is used to control the intensity of light source 3232. In some embodiments, the controller 3212 includes a wireless transmitter 3228 for transmitting images captured by the camera 3230 to the peripheral display device 3214 for viewing. In some embodiments, the peripheral display device 3214 is a television or computer screen, a mobile or portable display device, or a mobile phone. In some implementations, communication between the controller 3212 and the peripheral display device 3214 is wired. In the embodiments of the present description, catheter 3202, including attached camera 3230 and light source 3232, is disposable. In an embodiment, the entire catheter 3202 (from its distal end 3203 and including distal end 3207 with needle 3204, camera 3230, and light source 3232) is disposable to the proximal end of connecting tube 3216 (at the proximal end of connecting tube 3216, which is connected to fluid reservoir 3218), and the proximal end of electrical wire 3217 (at the proximal end of electrical wire 3217, which is connected to controller 3212), and all components therebetween.

Fig. 33 illustrates components of a distal end 3350 of an ablation system useful for treating Abnormal Uterine Bleeding (AUB) as used in accordance with embodiments of the present disclosure. The distal end 3350 includes a distal cover or positioning element 3352, an inner catheter shaft 3353, and a proximal cover or positioning element 3354 extending from the ablation catheter 3355, as well as a viewing device 3356 of a camera having a light source and an optical/electrical catheter 3342. The viewing device 3356 is positioned such that the proximal cover 3354 is distal to the viewing device along the length of the distal end 3350. In operation, a physician can use the viewing device 3356 to view the distal end of the catheter 3355 and the distal cover 3352, inner catheter shaft 3353 and proximal cover 3352 to ensure proper positioning of these elements prior to commencing vapor delivery. In an embodiment, the size, stiffness, and position of each cover 3352 and 3354 is adjustable (see fig. 18S, 18T, 19A-C for details). In embodiments, the length of the distal end 3350 between the distal cover 3352 and the proximal cover 3354 is also adjustable. Once adjusted, the length may be locked to position and hold the covers 3352 and 3354 in place.

Fig. 34 illustrates an image 3450 viewed on a display device 3452 such as an iPhone, according to some embodiments of the present description. The exemplary image shows that the distal shield 3454 (similar to the distal shield 3352) reaches the surface of the floor 3456, which may be the uterus, during an ablation procedure. Image 3450 is captured by a viewing device such as device 3356 of fig. 33.

Fig. 35A depicts a cross-sectional view of an embodiment of a combination catheter 3500a according to some embodiments of the present description, the combination catheter 3500a including a lumen 3502a for an optical/electrical catheter and a lumen 3504a for an ablation catheter. Referring also to fig. 33, the ablation catheter lumen 3504a is configured to receive an ablation catheter shaft 3355. In some embodiments, ablation catheter lumen 3504a has a diameter of about 3.5 mm. Similarly, lumen 3502a for an optical/electrical conduit is configured to receive an optical/electrical conduit 3342 component, which optical/electrical conduit 3342 component may include a viewing device 3356 having a light source and a camera. The lumen 3502a for an optical/electrical catheter includes a camera lumen 3506a for viewing electronics of the device 3356. In one embodiment, the shape of the camera lumen 3506a may be square with a diagonal distance extending to 1.5mm and a side length of 1.1mm. In some embodiments, the camera lumen 3506a is configured to receive electronics for an OV6946 camera with a resolution of 160,000 (400 x 400). In addition, lumen 3502a for an optical/electrical catheter includes lumen 3508a above and below lumen 3506a for holding electronics for a light source. Lumens 3508a may be configured to receive electronics for LEDs having an illuminance of about 700 lux. In some embodiments, lumen 3508a is rectangular in shape. The combination catheter 3500a may be circular with a diameter of about 5mm to accommodate the optical/electrical conduit 3342 alongside the ablation catheter 3355.

Fig. 35B illustrates a cross-sectional view of another embodiment of a combination catheter 3500B according to some embodiments of the disclosure, the combination catheter 3500B including a lumen 3502B for an ablation catheter, an optical/electrical catheter, and a lumen 3504B. Referring also to fig. 33, the ablation catheter lumen 3504b is configured to receive an ablation catheter shaft 3355. In some embodiments, the diameter of ablation catheter lumen 3504b is in the range of about 2.8mm to 3.0 mm. Similarly, lumen 3502b for an optical/electrical conduit is configured to receive an optical/electrical conduit 3342 component, which optical/electrical conduit 3342 component may include a viewing device 3356 having a light source and a camera. In some embodiments, lumen 3502b for an optical/electrical catheter includes a region of combined catheter 3500b having a diameter that may range from 1.7mm to 3.9 mm. In one embodiment, the diameter of the area of the combined conduit housing lumen 3502b for the optical/electrical conduit is about 2.0mm. The lumen 3502b for an optical/electrical catheter includes a camera lumen 3506b for viewing electronics of the device 3356. In one embodiment, the shape of the camera lumen 3506b may be square with a diagonal distance extending to 1.5mm and a side length of 1.1mm. In some embodiments, the camera lumen 3506b is configured to hold an OV6946 camera with a resolution of 160,000 (400 x 400). In addition, lumen 3502b for an optical/electrical catheter includes lumen 3508b for holding electronics for a light source above and below lumen 3506b. Lumen 3508b may be configured to receive electronics for an LED having a illuminance of 700 lux. In some embodiments, lumen 3508b is rectangular in shape. The combination catheter 3500b may be circular with a diameter of about 5.3mm to accommodate the optical/electrical conduit 3342 alongside the ablation catheter 3355.

Fig. 35C illustrates a cross-sectional view of yet another embodiment of a combination catheter 3500C according to some embodiments of the present specification, the combination catheter 3500C including a lumen 3502C for an optical/electrical catheter and a lumen 3504C for an ablation catheter 3504C. In an embodiment, catheter 3500c may have a diameter of approximately 8 mm. In an embodiment, optical/electrical conduit lumen 3502c has a diameter of 3.9mm and is configured to receive optical/electrical conduit 3342 of fig. 33, including electronics for both the camera and the LED. In an embodiment, the ablation catheter lumen 3504c has a diameter of 3.5mm and is configured to receive the ablation catheter 3355 of fig. 33. Thus, in different embodiments, different sizes of combined catheters, optical/electrical catheters, and ablation catheters are possible.

Handle mechanism

Various embodiments of a handle mechanism that may be used with an ablation device for prostate ablation are now described. While these embodiments are useful for prostate ablation, they may also be used with other systems of the present specification. Various embodiments of the handle mechanism include a system for needle deployment and retraction that may be implemented in different ways, such as, but not limited to, push/pull on buttons, push/pull on distal or proximal ends, sliding buttons in rails, push/pull rotation (plunger embodiment with wishbone paddles). The internal components of embodiments of the handle mechanism are typically made of stainless steel. The outer components of embodiments of the handle mechanism are typically made using a combination of ABS, plastic, rigid and elastomeric polymers, and other materials. Various embodiments also provide strain relief for the rear ends of fluid pipes and cables, as well as strain relief on the front ends to provide support for the conduit sections. In various embodiments, the handles described in this specification have a length ranging from 3 inches to 24 inches and a diameter ranging from 1/4 inch to 5 inches.

Fig. 36A through 36J illustrate an embodiment of a handle for use with the ablation system of the present specification, wherein the handle has a shape approximating that of a fishing rod, with an elongated cylindrical length.

Fig. 36A illustrates an embodiment of a catheter handle mechanism 3600a, according to some embodiments of the present description. The handle 3600a has an elongated tubular structure with a proximal end 3602a and a distal end 3604a, where the distal end corresponds to the end of the handle 3600a to which the catheter shaft 3606a is attached. Near the proximal end 3602a, the tubular body of the handle 3600a is slightly concave and shaped 3608a. In some embodiments, the contoured shape 3608a is disposed on two opposite sides of the handle 3600a near its proximal end 3602 a. The profile provides an ergonomic means to grasp the handle 3600a during use of the handle 3600a. The extent of the profile along the length of the handle is sufficient for the user to bend around the profile shape 3608a with their fingers to enclose the handle while holding the handle 3600a. The user's thumb may freely operate other functions configured in the handle 3600a, such as, but not limited to, a button 3610a configured to deliver vapor for ablation when pressed.

In addition, the handle 3600a may include a knob 3612a. The extent to which the user rotates knob 3612a may correspond to an equal amount of rotation of one or more needles at the distal end of catheter shaft 3606 a. Knob 3612a may also include a direction indicator 3614a that indicates the direction of the needle tip. In one embodiment, indicator 3614a is a narrow horizontal projection on a small portion of the circumference of knob 3612a. In another embodiment, the indicator 3614a is indicia, such as an arrow printed on the top surface of the knob 3612a, such that the indicia is visible to a user when the knob 3612a is rotated.

In an embodiment, a button or dial 3616a is provided along the length of the handle 3600a to enable a user to control the advancement and retraction of the needle at the distal end of the catheter shaft 3606 a. Dial 3616a can be rotated in a forward direction to push needle movement out of the distal end of catheter shaft 3606a and rotated in an opposite direction to retract the needle into shaft 3606 a.

Fig. 36B illustrates another embodiment of a catheter handle mechanism 3600B, according to some embodiments of the present disclosure. The handle 3600b has an elongated tubular structure with a proximal end 3602b and a distal end 3604b, where the distal end corresponds to the end of the handle 3600b to which the catheter shaft 3606b is attached. At the proximal end 3602b, the tubular body of the handle 3600b has a slightly larger diameter than the remaining body of the handle 3600b, providing a disc-shaped structure 3603b at the proximal end 3602 b. In some embodiments, the elongate tubular body of the handle 3600b is provided with a friction grip 3608b. The friction grip 3608b may be made of a material such as rubber to provide an ergonomic grip to the user.

Button 3610b is disposed on handle 3600b, preferably near distal end 3604b. Button 3610b enables a user to control the generation of vapor for ablation during deployment of the needle at the distal end of catheter shaft 3606 b. The user moves button 3610b forward to generate steam. As long as the user holds the button 3610b in the forward direction, vapor is generated. Once button 3610b is released, vapor generation is stopped or disabled so that it passively returns to its original position. In an embodiment, for safety reasons, button 3610b is configured to be capable of being press-locked in its home position and/or its forward position.

In addition, the handle 3600a may include a sliding portion 3612b attached at one of the proximal end 3602b or the distal end 3604b of the handle 3600 b. In operation, sliding portion 3612b forward triggers one or more needles to advance at the distal end of catheter shaft 3606b for deployment. Similarly, sliding the sliding portion 3612b in the opposite direction toward the proximal end 3602b of the handle 3600b may trigger retraction of the needle. The surface of the sliding portion 3612b is marked with a measurement value to indicate the degree of movement of the needle. In some embodiments, the indicia is supported by a tactile feedback feature in the form of a tab that indicates the unit of forward or rearward movement of the needle. In an embodiment, the sliding portion 3612b may also be rotated to control the rotation of the needle. An additional set of indicia on the surface of sliding portion 3612b may indicate the degree of rotation of the needle.

Fig. 36C illustrates another embodiment of a catheter handle mechanism 3600C, according to some embodiments of the present disclosure. The handle 360c has an elongated tubular structure with a proximal end 3602c and a distal end 3604c, where the distal end corresponds to the end of the handle 360c to which the catheter shaft 3606c is attached. In an embodiment, a strain relief 3605c is included at the distal end 3604c of the handle 360c to provide support to the catheter shaft 3606 c. The handle 360c is shaped like a pen with a narrow opening at its distal end 3604c from which the shaft 3606c emerges. Button 3610c is disposed proximate distal end 3604c to control the generation of vapor. Button 3610c can be a push button and can include a safety feature such that the button must be unlocked to operate to generate vapor. Dial 3612c is configured on one side of handle 360c, near distal end 3604c. During deployment, the user may rotate dial 3612c to rotate the needle positioned at the distal end of shaft 3606 c. In addition, button 3616C is preferably disposed intermediate the length of handle 360C, which enables the user to control the forward and rearward movement of the needle. In an embodiment, button 3616c is a sliding button, and the degree to which button 3616c slides in the forward or reverse direction determines the degree of forward and reverse movement of the needle. Indicia 3614c are provided along the slidable length of button 3616c indicating a measure of the distance the needle extends from the distal end of shaft 3606 c.

Fig. 36D illustrates another embodiment of a catheter handle mechanism 3600D, according to some embodiments of the present disclosure. The figure shows three views of handle 3600d—top view 3620d, side view 3622d, and bottom view 3624d. The handle 3600d has an elongated tubular structure with a proximal end 3602d and a distal end 3604d, where the distal end corresponds to the end of the handle 3600d to which a catheter shaft (not shown) is attached. At its distal end 3604d, handle 360c is tapered and shaped like a pen, having a narrow opening from which the shaft emerges. The proximal side of the handle 3600d is slightly curved downward to provide an ergonomic shape and to enable a user to grasp and manipulate the handle 3600d with a single hand. The handle 3600d is shaped and functions similar to a caulking gun. A button 3610d is provided proximal to the distal end 3604d to control the generation of vapor for ablation. In an embodiment, button 3610d is configured to control the system to deliver RF signals to electrodes in the catheter to convert the fluid to steam for ablation. A stem 3612d, similar to the stem of the caulking gun, is provided along the length of one side of the handle. The user may squeeze lever 3612d to advance the needle.

A function slide button 3614d is provided on the handle 3600d, preferably near its distal end. The button 3614d is configured to be slidable by a user to different positions along the length of the handle 3600d, which results in the positioning of one or more needles located at the distal end of the catheter shaft. In one embodiment, the first position of button 3614d corresponds to the position of the advancing needle, the second (intermediate) position corresponds to the position of the locking needle, and the third position corresponds to retracting the needle from its position. The user can operate the button 3614d using the thumb of the hand holding the handle 3600d. The rotator wheel button near the distal end 3604d is configured to be operated by the index finger of the same hand of the user to manage rotation of the distal tip of the needle cannula.

Fig. 36E illustrates another embodiment of a catheter handle mechanism 3600E, according to some embodiments of the present disclosure. The figure shows two views of handle 3600e—top view 3620e and side view 3622e. The handle 3600e has an elongated tubular structure with a proximal end 3602e and a distal end 3604e, where the distal end corresponds to the end of the handle 3600e to which the catheter shaft 3606e is attached. The middle portion 3609e along the circular length of the handle 3600e is configured in a smooth, bulbous shape to allow the user to grasp and manage the handle's function with a single hand. A triangular button 3610e projects horizontally outward from one side of the circular surface of the handle 36100e, which can be pressed by a user to initiate vapor generation. The distal section 3612e of the handle 3600e is configured as a needle control collar that can be rotated to rotate the needle and slid forward and backward to control advancement and retraction, respectively, of the needle from the distal end of the catheter shaft 3606 e.

Fig. 36F illustrates another embodiment of a catheter handle mechanism 3600F, according to some embodiments of the present disclosure. The figure shows two views of the handle 3600 f-side view 3620f and top view 3622f. The handle 3600f has an elongated tubular structure with a proximal end 3602f and a distal end 3604f, where the distal end corresponds to the end of the handle 3600f to which the catheter shaft 3606f is attached. In an embodiment, a first button 3610f is provided on a first side of the handle 3600f to enable a user to use their middle finger to operate the button to initiate the generation of vapor. In an embodiment, the first button 3610f is positioned near the proximal end 3602f of the handle 3600 f. In some embodiments, a second or top side of the handle 3600f that is rotated 90 degrees from the first side is provided with a rotation wheel 3612f, the rotation wheel 3612f being controllable by a user with thumb and pointer fingers of the same hand that holds the handle 3600f to rotate a needle positioned at the distal end of the shaft 3606 f. The flat surface of the swivel wheel 3612f is positioned horizontally relative to the surface of the handle 3600 f. In an embodiment, the swivel wheel 3612f includes a plurality of haptic members 3613f that facilitate user manipulation of the swivel wheel 3612 f. A second button 3616f is provided to control the deployment of the needle. The user's thumb may be used for the administration button 3616f. In various embodiments, the button 3616f may be a push button or a two-position slide button. In an embodiment, second button 3616f can be pressed to deploy the needle from the distal end of shaft 3606f and release second button 3616f to retract the needle. In other embodiments, second button 3616f can be slid forward to extend the needle and backward to retract the needle. In an embodiment, the second button 3616f is positioned on a third side of the handle opposite the first side and at a location near the distal end 3604f of the handle 3600 f.

Fig. 36G illustrates another embodiment of a catheter handle mechanism 3600G, according to some embodiments of the present disclosure. The figure shows two views of the handle 3600g—side view 3620g and top view 3622g. The handle 3600g has an elongated tubular structure with a proximal end 3602g and a distal end 3604g, where the distal end corresponds to the end of the handle 3600g to which the catheter shaft 3606g is attached. In some embodiments, trigger 3610g is positioned on a first side of handle 3600g near distal end 3604g, trigger 3610g being configured to enable a user to operate the trigger using their index finger in order to initiate the generation of vapor. A rotation wheel 3612g is provided at the center of the handle 3600 g. In an embodiment, the swivel wheel 3612g is positioned within the handle body 3601g of the handle 3600g and extends from the top and bottom sides of the handle body 3601g of the handle 3600 g. The swivel wheel 3612g is configured to be freely rotatable within the handle body 3601g by a user. The circumference of the rotating wheel 3612g emerges from two opposite sides of the handle body 3601g of the handle. Rotating wheel 3612g allows a user to rotate a needle positioned at the distal end of shaft 3606g using one of a thumb or finger. Additionally, in some embodiments, a button 3616g is provided for deploying the needle from the catheter shaft 3606g, the button 3616g being positioned on the second side of the handle, rotated 90 degrees from the first side of the handle and near the distal end 3604g.

Fig. 36H illustrates another embodiment of a catheter handle mechanism 3600H, according to some embodiments of the present disclosure. The handle 3600h has an elongated tubular structure with a proximal end 3602h and a distal end 3604h, where the distal end corresponds to the end of the handle 3600h to which the catheter shaft 3606h is attached. The tubular body of the handle 3600h has a varying diameter along its length such that the diameter of the handle 3600h at the center along its length is greater than the diameter of the handle 3600h at its distal and proximal ends, thereby providing a "ski" grip for the user. In an embodiment, a disc-shaped member 3603h is included at the proximal end 3602h of the handle 3600h to help secure a user's grip. A button 3610h is provided on one side of the handle 3600h to enable a user to use their index finger to operate the button 3610h to initiate the generation of vapor. The distal portion of the handle 3600h is provided with a first swivel 3612h. The circumference of the first swivel wheel 3612h is greater than the circumference of the handle body 3601h at the distal portion. First swivel 3612h allows a user to swivel a needle positioned at the distal end of shaft 3606h using one of a thumb or finger. In addition, a finger grip 3616h is provided near the distal end 3606h of the handle 3600 h. In an embodiment, finger grip 3616h has a suture wing shape, similar to a butterfly suture. Finger grip 3616h can be gripped by a user and moved in a longitudinal direction to move catheter shaft 3606h back and forth to advance or retract the needle.

Fig. 36I illustrates yet another embodiment of a catheter handle mechanism 3600I, according to some embodiments of the present disclosure. The handle 3600i has an elongated tubular structure with a proximal end 3602i and a distal end 3604i, where the distal end corresponds to the end of the handle 3600i to which the catheter shaft 3606i is attached. The tubular body of the handle 3600i has a varying diameter along its length such that the diameter of the handle 3600h at the center along its length is greater than the diameter of the handle 3600h at its distal and proximal ends, thereby providing a "ski" grip for the user. In an embodiment, button 3610i is positioned on one side of handle 3610i and near the center of handle 3610i along the length of handle 3610i, button 3610i being provided to enable a user to use their index finger to operate button 3610i in order to initiate the generation of vapor. In some embodiments, first swivel 36121 is positioned along its length near the center of handle 36001. First swivel wheel 36121 allows a user to swivel a needle positioned at the distal end of shaft 36061 using a finger. Additionally, in some embodiments, a second swivel 3616i positioned distally of the button 3610i and the first swivel 3612i along the length of the handle 36001 is provided for deploying the needle from the catheter shaft 3606 i.

Fig. 36J illustrates another embodiment of a catheter handle mechanism 3600J, according to some embodiments of the present disclosure. The embodiment depicted in fig. 36J includes a combination of preferred functions and features in a fishing rod subject handle for controlling the ablation system of the present specification. The figure shows two views of the handle 3600 j-a side horizontal view 3620j and a top perspective view 3622j. The handle 3600j has a tubular structure with a proximal end 3602j and a distal end 3604j and curves smoothly to provide an ergonomic grip for a user. A catheter shaft 3606j extends from the distal end 3604 j. In various embodiments, catheter shaft 3606j extends from distal end 3604j along the longitudinal axis of handle 3600 j. In some embodiments, the handle 3600j includes a first button 3616j, the first button 3616j being on a portion proximate the distal end 3604j and being positioned on either a lateral first side 3621j or a lateral second side 3623j of the handle 3600 j. The first button 3616j is configured such that a user's finger can press the button while also grasping the grip portion with the remaining fingers of the same hand. In some embodiments, button 3616j is configured to incrementally or immediately retract needle 3641j positioned at the distal end of catheter shaft 3606j when pressed on first side 3621 j. In some embodiments, button 3616j is configured to incrementally extend needle 3641j positioned at the distal end of catheter shaft 3606j when pressed on second side 3623 j. In some embodiments, the function of button 3616j is reversed when pressed. In some embodiments, the handle 3600j includes a distal portion 3613j at a distal end 3604j thereof, the distal portion 3613j extending along a longitudinal axis of the handle 3600j and including a first button 3616j. Catheter shaft 3606j extends from distal portion 3613j along the same longitudinal axis as distal portion 3613 j. In an embodiment, first strain relief 3618j is positioned at a distal end of distal portion 3613j and is configured to provide support for catheter shaft 3606j as catheter shaft 3606j exits from distal portion 3613 dj.

A second button 3610j is located on the top or third side 3607j near the distal end 3604j and on the main body 3609j of the handle 3600j to initiate vapor generation. In other embodiments, the second button 3610j is positioned on the bottom or fourth side 3605j of the handle. In some embodiments, the second button 3610j is a push button having a safety feature that enables a user to lock the button when operation of the button is not required. In operation, third button 3610j must first be slid forward and then pushed downward to initiate vapor generation. In an embodiment, third button 3610j is a push and slide button configured to be pushed in and slid forward to initiate vapor generation. In an embodiment, a rotating dial 3612j is included in the distal end 3604j of the handle, between the first strain relief 3618j and the distal portion 3613j at a location distal of the button 3616j, and is configured to be rotated by a user to rotate the needle 3641j at the distal end of the shaft 3606 j. In some embodiments, rotating dial 3612j includes recessed arrow 3632j and handle 3600j includes an angle indicator indicia 3642j proximate rotating dial 3612j to indicate to a user the angle of rotation of needle 3641j when arrow 3632j and specific indicia 3642j are aligned.

In some embodiments, catheter shaft 3606j includes a needle 3641j, a soft-bent tubing tip 3643j, and a positioning element 3645j at its distal end, the positioning element 3645j configured to stabilize catheter shaft 3606j in the patient's bladder. Soft catheter tip 3643j is configured to prevent trauma to body tissue during advancement of catheter shaft 3606 j. The handle also includes a fluid line 3651j extending from its proximal end 3602j and through the body 3609j of the handle into a catheter shaft 3606j, the catheter shaft 3606j being configured to receive a fluid for conversion to steam. The handle 3600j also includes a power wire 3653j, the power wire 3653j extending from a proximal end 3602j thereof, through a body 3609j of the handle and into a proximal portion of the catheter shaft 3606j, the power wire 3653j configured to receive an electrical current to heat an electrode positioned within the proximal portion of the catheter shaft to convert the fluid into steam for ablation. In some embodiments, a second strain relief 3628j is positioned at the proximal end 3602j of the handle to provide support for the fluid line 3651j and the power line 3653 j.

It should be noted that the various embodiments described in the context of fig. 36A through 36J may use features and configurations of each other. In some embodiments, the structure and shape of the handle may be any of the structures and shapes depicted in the figures. Similarly, the type of control (button, slider, wheel, lever or trigger) for initiating vapor generation, the combination of the rotation and position of the needle may be selected from different embodiments.

Fig. 37A-37F illustrate an embodiment of a handle for use with the ablation system of the present specification, wherein the handle is shaped to approximate the shape of a pistol grip, having a first portion and a second portion disposed at an angle in the range of 0 to 180 degrees to each other, such that the first portion is configured to be held in a user's hand, and the second portion extends from an end of the first portion and includes a catheter extending therefrom.

Fig. 37A illustrates an embodiment of a catheter handle mechanism 3700a according to some embodiments of the present disclosure. The shape of the handle 3700a is similar to a hand gun or pistol, which allows the physician to conveniently manipulate the handle 3700a for ablation therapy. The handle 3700a includes a first portion 3701a and a second portion 3703a, the first portion 3701a and the second portion 3703a being coupled together relative to one another in a range of 0 to 180 degrees such that the first portion 3701a is configured to be held in a hand of a user and the second portion 3703a extends from an end of the first portion 3701a and includes a catheter shaft 3706a extending therefrom. A strain relief 3704a configured to provide support to the catheter shaft 3706a is positioned at the distal end of the second portion 3702 a. The ablation needle is coupled to catheter shaft 3706a, as explained in the embodiments above, and is used to deliver vapor to the target tissue. In an embodiment, the first portion 3701a is provided with a friction grip 3708a to secure the user's grip. The friction grip 3708a may be made of a material such as rubber to provide an ergonomic grip to the user. In an embodiment, a first button 3710a located on the proximal top edge of the connection of the first portion 3701a and the second portion 3703a is provided to initiate vapor generation. In some embodiments, the first button 3710a is a push button having a safety feature that enables a user to lock the button when operation of the button is not required. In an embodiment, the second portion 3703a of the handle 3700a includes a rotation wheel 3712a, the rotation wheel 3712a rotating along a longitudinal length of the second portion 3702 a. The rotation wheel 3712a allows the user to rotate the wheel 3712a using a finger, which results in rotation of the needle(s) positioned at the distal end of the catheter shaft 3706a. Additionally, in some embodiments, the second button 3714a and the third button 3716a are disposed along the distally facing surface 3709a of the first portion 3701 a. In an embodiment, the second button 3714a is configured to be able to retract the needle immediately when pressed, while the third button 3716a is configured to advance the needle incrementally a preset distance, e.g., 5mm, each time the third button 3716a is pressed.

Fig. 37b illustrates another embodiment of a catheter handle mechanism 3700b according to some embodiments of the present disclosure. The shape of the handle 3700b is similar to a hand gun or pistol, which allows the physician to conveniently manipulate the handle 3700b to perform an ablation treatment. Handle 3700b includes a first portion 3701b and a second portion 3703b, the first portion 3701b and the second portion 3703b being coupled together relative to one another in a range of 0 to 180 degrees such that the first portion 3701b is configured to be held in a hand of a user and the second portion 3703b extends from an end of the first portion 3701b and includes a catheter shaft 3706b extending therefrom. The ablation needle is coupled to catheter shaft 3706b, as explained in the embodiments above, and is used to deliver vapor to the target tissue. In an embodiment, the first portion 3701b may be provided with a friction grip to provide an ergonomic grip to the user. A first button 3710b, positioned on the top surface of the second portion 3703b of the handle 3700b in an embodiment, is provided to initiate vapor generation. In some embodiments, the first button 3710b is a push button having a security feature that enables a user to lock the first button when it is not needed to operate the first button. In an embodiment, knob 3712b is included at the distal end of second portion 3703b, which can be rotated by a user to rotate a needle positioned at the distal end of catheter shaft 3706b. In an embodiment, a second button 3714b is provided on the proximal top edge of the connection of the first and second portions 3701b, 3703b to enable the user to retract the needle immediately when pressed. In some embodiments, ratchet arm 3716b is disposed at a distal bottom surface where first portion 3701b and second portion 3703b are connected. The user may continuously squeeze ratchet arm 3716b to incrementally advance the needle a preset distance, such as 5mm.

Fig. 37C illustrates another embodiment of a catheter handle mechanism 3700C according to some embodiments of the present disclosure. The shape of the handle 370c is similar to a hand gun or pistol, which allows the physician to conveniently manipulate the handle 370c to perform an ablation treatment. The handle 370c includes a first portion 3701c and a second portion 3703c, the first portion 3701c and the second portion 3703c being coupled together relative to one another in a range of 0 to 180 degrees such that the first portion 3701c is configured to be held in a hand of a user and the second portion 3703c extends from an end of the first portion 3701c and includes a catheter shaft 3706c extending from the first portion 3701 c. In some embodiments, the proximal section 3713c of the second portion 3703c extends proximally beyond the intersection of the first portion 3701c and the second portion 3703 c. The ablation needle is coupled to catheter shaft 3706c, as explained in the embodiments above, and is used to deliver the vapor to the target tissue. The first portion 3701c may be provided with a friction grip to provide an ergonomic grip to the user. A button 3710c is provided on one side of the second portion 3702c of the handle 3700c to initiate vapor generation. In some embodiments, button 3710c is a push button with a security feature that enables a user to lock the button when operation of the button is not required. In some embodiments, the proximal section 3713c of the second portion 3703c includes a knob 3712c at its proximal end, the knob 3712c being rotatable by a user to rotate a needle positioned at the distal end of the shaft 3706c. In an embodiment, a circular trigger ring 3716c extends proximally of the distal end of the handle 3700c from the bottom surface of the second portion 3703c of the handle 3700 c. The user may continuously squeeze trigger ring 3716c to incrementally advance the needle a preset distance, such as 5mm. In some embodiments, trigger ring 3716c may be fully squeezed to retract the needle. In other embodiments, knob 3712c facilitates needle retraction.

Fig. 37D illustrates another embodiment of a catheter handle mechanism 3700D according to some embodiments of the present disclosure. The shape of the handle 3700d is similar to a hand gun or pistol, which allows the physician to conveniently manipulate the handle 3700d for ablation therapy. The handle 3700d includes a first portion 3701d and a second portion 3703d, the first portion 3701d and the second portion 3703d being coupled together relative to one another in a range of 0 to 180 degrees such that the first portion 3701d is configured to be held in a hand of a user and the second portion 3703d extends from an end of the first portion 3701d and includes a catheter shaft 3706d extending therefrom. The ablation needle is coupled to the catheter shaft 3706d, as explained in the embodiments above, and is used to deliver steam or vapor to the target tissue. In some embodiments, the handle 3700d includes a strain relief 3718d at the distal end of the second portion 3703d to provide support to the catheter shaft 3706d. The first portion 3701d may be provided with a friction grip to provide an ergonomic grip to the user. A button 3710d is provided to initiate vapor generation. In some embodiments, button 3710b is positioned on a side of second portion 3703d adjacent to proximal end 3702d of handle 3700 d. In other embodiments, button 3710b is positioned on the top surface of second portion 3703d, near proximal end 3702d of handle 3700 d. In some embodiments, button 3710b is a push or rotate button with a security feature that enables a user to lock the button when operation of the button is not required. Knob 3712d is positioned at the distal end of second portion 3712d and is configured to be rotated by a user to rotate a needle positioned at the distal end of shaft 3706d. A sliding button 3714d is provided on one or both sides of the second portion 3703d and is configured to be slid forward by a user to extend the needle from the distal end of the catheter shaft 3706 and slid rearward to retract the needle. In some embodiments, trigger arm 3716d is disposed at a distal edge where first portion 3701d and second portion 3703d are connected. The user may continuously squeeze the trigger arm 3716d to incrementally advance the needle a preset distance, such as 5mm. In other embodiments, the handle 3700d includes a directional button 3715d that can be pushed by the user to incrementally advance or retract the needle a preset distance.

Fig. 37E illustrates another embodiment of a catheter handle mechanism 3700E according to some embodiments of the present disclosure. The shape of the handle 3700e is similar to a hand gun or pistol, which allows the physician to conveniently manipulate the handle 3700e to perform an ablation treatment. Handle 3700e includes a first portion 3701e and a second portion 3703e, the first portion 3701e and the second portion 3703e coupled together relative to one another in a range of 0 to 180 degrees such that the first portion 3701e is configured to be held in a user's hand and the second portion 3703e extends from an end of the first portion 3701e and includes a catheter shaft 3706e extending from the first portion 3701 e. The ablation needle is coupled to the catheter shaft 3706e, as explained in the embodiments above, and is used to deliver steam or vapor to the target tissue. In an embodiment, the first portion 3701e includes a slot 3709e for receiving a Printed Circuit Board (PCB) 3708e configured to removably place the PCB for the control handle 3700e. The first portion 3701e may be provided with a friction grip to provide an ergonomic grip to the user. A button 3710e is provided on the proximal surface of the first portion 3701e to initiate vapor generation. In some embodiments, button 3710e is a push or rotate button with a security feature that enables a user to lock the button when operation of the button is not required. Knob 3712e, which in embodiments is positioned at the proximal end of second portion 3703e, is configured to be rotated by a user to rotate a needle positioned at the distal end of shaft 3706e. The trigger arm 3716e is disposed on the bottom surface along the length of the segment portion 3703e, extending downwardly at an angle to the second portion 3703e of the handle 3700e. In some embodiments, the trigger arm 3716e is shaped as an arc. A portion 3717e of the trigger arm 3716e extends within the second portion 3703e of the handle 3700e and is attached to the sheath 3719e of the catheter shaft 3706e. The trigger arm 3716e is movable about the pivot point 3721e, and when the trigger arm 3716e is squeezed, the trigger arm 3716e is configured to pull the sheath 3719e back to deploy the needle from the catheter shaft 3706e. The user may continuously squeeze the trigger arm 3716e to incrementally advance the needle a preset distance, such as 5mm. A length of tubing 3723e is shown extending through knob 3712e, second portion 3703e, and catheter shaft 3706e, and is configured to receive fluid to be heated and converted to steam for ablation.

Fig. 37F illustrates another embodiment of a catheter handle mechanism 3700F according to some embodiments of the present disclosure. The embodiment depicted in fig. 37F includes a combination of preferred functions and features in a gun or pistol theme handle for controlling the ablation system of the present specification. The figure shows two views of handle 3700f—side vertical view 3720f and side vertical perspective view 3722f. The handle 3700f includes a first portion 3701f and a second portion 3703f, the first portion 3701f and the second portion 3703f being coupled together relative to one another in a range of 0 to 180 degrees such that the first portion 3701f is configured to be held in a hand of a user and the second portion 3703f extends from an end of the first portion 3701f and includes a catheter shaft 3706f extending from the first portion 3701 f. The first portion 3701f of the handle 3700f has a tubular structure and is smoothly curved to provide an ergonomic grip to a user. The catheter shaft 3706f extends from the distal end 3704f of the second portion 3703 f. In various embodiments, the catheter shaft 3706f extends from the distal end 3704f along a longitudinal axis of the second portion 3703f of the handle 3700 f. In some embodiments, handle 3700f includes a first button 3714f and a second button 3716f along a length of a distal or first side 3705f of first portion 3701 f. The first button 3714f and the second button 3716f are configured such that a user's finger can press the buttons while also grasping the handle with the same finger. In some embodiments, the first button 3714f is configured to incrementally or immediately retract the needle 3741f positioned at the distal end of the catheter shaft 3706f when pressed, while the second button 3716f is configured to incrementally advance the needle 3741f when pressed. In other embodiments, the functionality of buttons 3714f, 3716f is reversed. The buttons 3714f, 3716f may be shaped to provide an ergonomic grip of the first portion 3701f of the handle 3700f in a user's hand. In some embodiments, the handle 3700f includes a distal portion 3713f at a distal end 3704f thereof, the distal portion 3713f extending along a longitudinal axis of the second portion 3703f of the handle 3700 f. In an embodiment, the catheter shaft 3706f extends from the distal portion 3713f on the same longitudinal axis of the distal portion 3713 f. In an embodiment, the first strain relief 3718f is positioned at the distal end of the distal portion 3713f and is configured to provide support to the catheter shaft 3706f as the catheter shaft 3706f exits from the distal portion 3713 f.

A third button 3710f is positioned on the proximal end 3722f of the second portion 3703f, wherein the first portion 3701f and the second portion 3703f meet to initiate vapor generation. In some embodiments, the third button 3710f is a push button having a safety feature that enables the user to lock the button when operation of the button is not required. In an embodiment, the third button 3710f includes a slider 3711f, and the slider 3711f must first be pushed forward or upward to unlock the button 3710f. The entire button 3710f may then be pressed to initiate vapor generation. Sliding the slider 3711f downward slides the lock button 3710f and prevents inadvertent actuation. In an embodiment, the rotating dial 3712f is included in and extends through the second portion 3703f of the handle such that a portion of the rotating dial 3712f extends from a side of the second portion and is accessible to a user. In an embodiment, the rotation dial 3712f is configured to be rotated by a user to rotate the needle 3741f at the distal end of the shaft 3706 f. In some embodiments, the rotating dial 3712f includes a recessed arrow 3732f and the handle 3700f includes a degree indicator marking 3742f proximate to the rotating dial 3712f to indicate to a user the degree of rotation of the needle 3741f when the arrow 3732f is aligned with the specific marking 3742 f.

In some embodiments, the catheter shaft 3706f includes a needle 3741f at its distal end, a soft bend end 3743f, and a positioning element 3745f, the positioning element 3745f configured to stabilize the catheter shaft 3706f in the patient's bladder. The soft catheter tip 3743f is configured to prevent trauma to body tissue during advancement of the catheter shaft 3706 f. The handle also includes a fluid line 3751f extending from the proximal end 3702f of the first portion 3701f and through the body 3709f of the handle into the catheter shaft 3706f, the fluid line 3751f configured to receive fluid for conversion to steam. The handle 3700f further includes a power cord 3753f, the power cord 3753f extending from the proximal end 3702f of the first portion 3701f, through the body 3709f of the handle and into the proximal portion of the catheter shaft 3706f, the power cord 3753f configured to receive an electrical current to heat an electrode positioned within the proximal portion of the catheter shaft to convert the fluid into steam for ablation. In some embodiments, a second strain relief 3728f is positioned at the proximal end 3702f of the first portion 3701f to provide support to the infusion tube 3751f and the power cord 3753 f.

Fig. 38 illustrates another embodiment of a catheter handle mechanism 3800 according to some embodiments of the present disclosure. The shape of the handle 3800 is configured to adjust about the pivot 3830 between a hand gun or handgun similar to the shape shown in fig. 37A-37E and a linear or tubular fishing rod similar to the shape shown in fig. 36A-36I. The transformation of the shape of the handle 3800 allows the user to adjust the handle 3800 to fit a grip that facilitates the user in performing ablation therapy, and is particularly useful in real-time imaging and ablation. The handle 3800 includes a first portion 3801 and a second portion 3803e, the first portion 3801 and the second portion 3803e coupled together at a pivot 3830 and movable relative to one another about the pivot 3830 in a range of 0 to 180 degrees such that the first portion 3801 is configured to be held in a user's hand and the second portion 3803 extends from an end of the first portion 3801 and includes a catheter shaft 3806 extending therefrom. The figure shows three side views of the handle 3800—view 3832 shows the structure of the handle 3800 when the first portion 3801 of the handle 3800 is at an angle between 90 degrees and 180 degrees relative to the second portion 3803 of the handle 3800; view 3834 shows the structure of handle 3800 when first portion 3801 is rotated 180 degrees about pivot 3800 relative to second portion 3803, aligning first portion 3801 horizontally with second portion 3803, thereby providing a linear structure approximating a fishing rod shape and providing a longitudinal grip for a user; also, view 3836 shows the structure of the handle 3800 as the first portion 3801 of the handle 3800 is rotated about the pivot 3830 at a 90 degree angle relative to the second portion 3803 of the handle, thereby creating a pistol grip for the user. In an embodiment, the first portion 3801 may be rotated to any angle between 0 degrees and 180 degrees relative to the second portion 3803 and may be secured at a selected angle by a user by activating the lock 3805. The locking member 3805 may be disabled to allow rotation about the pivot 3830. In an embodiment, the trigger arm 3816 may be disposed at a bottom surface of the second portion 3803, and the trigger arm 3816 may be depressed to advance the needle a preset distance increment in the catheter shaft 3806. In one embodiment, once the needle is advanced to a maximum distance by repeatedly pressing the trigger 3816, further pressing of the trigger results in retraction of the needle. Retraction may be at the instant of each depression of the trigger arm 3816, or one distance increment at a time. The handle 3800 can also include a button 3810, in an embodiment, the button 3810 being positioned on a top surface of the second portion 3803 to enable a user to activate or deactivate the generation of vapor for ablation.

39A-39D illustrate an embodiment of a handle for use with the ablation system of the specification, wherein the handle is shaped to approximate the shape of a video game controller, includes a plurality of actuators in the form of buttons, knobs, and slides, and includes a catheter shaft extending from a portion of the handle.

Fig. 39A illustrates another embodiment of a catheter handle mechanism 3900a according to some embodiments of the present disclosure. Handle 3900a has a linear configuration with a non-uniform diameter along its length. In an embodiment, the handle 3900a has a diameter at a central point along its length that is greater than the diameters at its proximal end 3902a and distal end 3904a, and curves smoothly to provide an ergonomic grip to the user. Catheter shaft 3906a is attached near distal end 3904a of handle 3900 a. In one embodiment, catheter shaft 3906a extends perpendicularly from the elongated linear structure of handle 3900 a. In some embodiments, a strain relief 3918a is included at the distal end 3904a of the handle 3900a to provide support for the catheter shaft 3906a as the catheter shaft 3906a exits from the body of the handle 3900 a. In an embodiment, knob 3912a is positioned at distal end 3904a, proximal to the exit of catheter shaft 3906a from handle 3900a, and is configured to enable a user to rotate a needle positioned at the distal end of shaft 3906 a. In an embodiment, the handle 3900a includes a first button 3916a and a second button 3914a on a first side of the handle 3900 a. The needle is advanced incrementally by pressing the first button 3916a and retracted immediately or incrementally by pressing the second button 3914a depending on the strength of the press. Buttons 3914a and 3916a may be positioned along the vertical length of handle 3900a, aligned with and below the outlet of catheter shaft 3906 a. A third button 3910a is disposed on a second side opposite the first side and positioned proximate the distal end 3904a of the handle to initiate vapor generation. In some embodiments, the third button 3910a is a push or rotate button having a security feature that enables a user to lock the third button 3910a when the third button 3910a does not need to be operated.

Fig. 39B illustrates another embodiment of a catheter handle mechanism 3900B according to some embodiments of the present disclosure. The figure shows two views of handle 3900 b-side horizontal view 3920b and top horizontal view 3922b. Handle 3900b has a tubular structure with a proximal end 3902b and a distal end 3904b and curves smoothly to provide an ergonomic grip for a user. In some embodiments, the handle 3900b is shaped to provide a smooth groove 3907g around a portion of the circumference of the tubular body to place a finger in a user's hand to ergonomically grasp the handle 3900b. Catheter shaft 3906b extends from distal end 3904b of handle 3900b. Catheter shaft 3906b extends linearly along the longitudinal axis of handle 3900b. In some embodiments, a strain relief 3918b is positioned at the distal end 3904b of the handle 3900b to provide support for the catheter shaft 3906b as the catheter shaft 3906b exits from the body of the handle 3900b. Button 3910b is disposed on a surface of handle 3900b near distal end 3904b on a second side opposite the first side including recess 3907g for retention to initiate vapor generation. In some embodiments, button 3910b is a push or rotate button having a security feature that enables a user to lock the button when operation of the button is not required. In an embodiment, knob 3913b may be provided on a surface of the handle, which enables a user to rotate a needle positioned at the distal end of shaft 3906 b. Alternatively, a combination of buttons 3916b may be provided to manipulate movement of the needle for rotation and advancement and retraction. In one embodiment, the combination of buttons 3916b includes a slider button 3926b that moves toward the distal end 3904b to advance and toward the proximal end 3902b to retract the needle. The same button may be slid laterally or switched to effect incremental rotation of the needle. The track 3927b for sliding may be marked with a predetermined amount of distance the needle may be advanced or retracted. The needle may also be advanced and retracted incrementally by sliding button 3926b in the desired direction. Combination button 3916b may be positioned along the longitudinal length of handle 3900b in alignment with button 3910b for initiating the generation of vapor. In some alternative embodiments, the combination of buttons 3916b includes a set of four directional buttons 3928b, wherein the arrow indicates a direction of movement (forward, retract, left rotation, right rotation) to effect incremental movement of the needle in that direction.

Fig. 39C illustrates another embodiment of a catheter handle mechanism 3900C according to some embodiments of the present disclosure. The figure shows two views of the handle 3900 c-a side horizontal view 3920c and a top horizontal view 3922c. Handle 3900c has a tubular structure with a proximal end 3902c and a distal end 3904c and curves smoothly to provide an ergonomic grip for a user. In some embodiments, the handle 3900c is shaped to provide a smooth groove 3907c around a portion of the circumference of the tubular body to place a finger in a user's hand to ergonomically grasp the handle 3900c. Catheter shaft 3906c extends from distal end 3904c of handle 3900c. The catheter shaft 3906c extends linearly along the longitudinal axis of the handle 3900c. In some embodiments, a strain relief 3918c is positioned at the distal end 3904c of the handle 3900c to provide support for the catheter shaft 3906c as the catheter shaft 3906c exits from the body of the handle 3900c. In an embodiment, the first knob 3912c is positioned at the distal end 3904c of the handle 390c, proximal of the strain relief 3918c, and is configured to be rotated by a user to rotate a needle positioned at the distal end of the shaft 3906 c. In other embodiments, knob 3932c is positioned on a second side of handle 390c opposite the first side configured with groove 3907c, with or without first knob 3912c, and functions the same as first knob 3912 c. Positioning knob 3932c on the side of handle 3900c may be preferred for single-handed use, such that a user can use the fingers of the same hand to operate knob 3932c while grasping handle 3900c. In an embodiment, the sliding button 3916c is positioned on a second side of the handle 390c and is configured to slide within the track 3917c toward the distal end 3904c such that the needle is incrementally advanced over a range extending from the catheter shaft 3906 c. Similarly, button 3916c slides proximally to retract the needle. Alternatively, a combination of directional buttons 3926c may be provided to manipulate the movement of the needle for advancement and retraction. In one embodiment, the combination of buttons 3926c includes a button directed to distal end 3904c for advancement and another button directed to proximal end 3902c for retraction of the needle. Combination button 3926c may be positioned along the longitudinal length of handle 3900c in alignment with button 3910c for initiating the generation of vapor.

Fig. 39D illustrates another embodiment of a catheter handle mechanism 3900D according to some embodiments of the present disclosure. The embodiment depicted in fig. 39D includes a combination of preferred functions and features in a video game controller theme handle for controlling the ablation system of the present specification. The figure shows two views of handle 3900 d-a side horizontal view 3920d and a top perspective view 3922d. Handle 3900d has a tubular structure with a proximal end 3902d and a distal end 3904d and curves smoothly to provide an ergonomic grip for a user. A catheter shaft 3906d extends from the distal end 3904 d. In various embodiments, catheter shaft 3906d extends from distal end 3904d at an angle in the range of 0 to 180 degrees from the longitudinal axis of handle 3900 d. In some embodiments, the handle 3900d includes a first button 3914d and a second button 3916d along a length of a bottom or first side 3905d of the handle 3900 d. The first button 3914d and the second button 3916d are configured such that a user's finger can press the buttons while also grasping the handle with the same finger. In some embodiments, the first button 3914d is configured to incrementally or immediately retract the needle 3941d positioned at the distal end of the catheter shaft 3906d when pressed, while the second button 3916d is configured to incrementally advance the needle 3941d when pressed. In other embodiments, the functions of buttons 3914d, 3916d are reversed. Buttons 3914d, 3916d may be shaped to provide an ergonomic grip of handle 3900d in a user's hand. In some embodiments, the handle 3900d includes a distal portion 3913d at a distal end 3904d thereof, the distal portion 3913d extending at an angle relative to a longitudinal axis of the handle 3900 d. In an embodiment, the angular range is between 0 degrees and 180 degrees. The catheter shaft 3906d extends from the distal portion 3913d along the same longitudinal axis as the distal portion 3913 d. In an embodiment, the first strain relief 3918d is positioned at the distal end of the distal portion 3913d and is configured to provide support for the catheter shaft 3906d as the catheter shaft 3906d exits from the distal portion 3913 d.

A third button 3910d is located on the top or second side 3907d, near the distal end 3904d, and opposite the buttons 3914d and 3916d on the first side 3905d to initiate vapor generation. In some embodiments, the third button 3910d is a push or rotate button having a security feature that enables a user to lock the button when operation of the button is not required. In an embodiment, the third button 3910d is a push and slide button configured to be pushed in and slid forward to initiate vapor generation. In an embodiment, a rotating dial 3912d is included in the distal end 3904d of the handle, at the location where the distal end 3904d and distal portion 3913d meet, and is configured to be rotated by a user to rotate the needle 3941d at the distal end of the shaft 3906 d. In some embodiments, rotating dial 3912d includes recessed arrow 3932d and handle 3900d includes angle indicator markings 3942d proximate to rotating dial 3912d to indicate to a user the angle of rotation of needle 3941d when arrow 3932d and a particular marking 3942d are aligned.

In some embodiments, catheter shaft 3906d includes a needle 3941d, a soft bend tip 3943d, and a positioning element 3945 at a distal end thereof, the positioning element 3945 configured to stabilize the catheter shaft 3906d in a patient's bladder. Soft catheter tip 3943d is configured to prevent trauma to body tissue during advancement of catheter shaft 3906 d. The handle also includes a fluid line 3951 extending from its proximal end 3902d and through the body 3909d of the handle into the catheter shaft 3906d, the catheter shaft 3906d being configured to receive a fluid for conversion to steam. The handle 3900d also includes an electrical power cord 3953, the electrical power cord 3953 extending from a proximal end 3902d thereof through the body 3909d of the handle and into a proximal portion of the catheter shaft 3906d, the electrical power cord 3953 configured to receive an electrical current to heat an electrode positioned within the proximal portion of the catheter shaft to convert the fluid into steam for ablation. In some embodiments, a second strain relief 3928d is positioned at the proximal end 3902d of the handle to provide support for the infusion tube 3951d and the power cord 3953 d.

Fig. 40A-41 illustrate an embodiment of a handle for use with the ablation system of the specification, wherein the handle is shaped to approximate the shape of a syringe, including an actuation mechanism at a proximal end of the handle and a catheter shaft extending from a distal end of the handle.

Fig. 40A illustrates another embodiment of a catheter handle mechanism 4000A according to some embodiments of the present description. The figure shows two views of handle 4000 a-top view 4020a and side view 4022a. Handle 4000a is configured to operate similar to a syringe. The handle 4000a is shaped in the form of an elongate tubular structure in which the distal end 4004a tapers to have a conical shape and decreases in diameter as it extends distally to provide an outlet for the catheter shaft 4006 a. The proximal end 4002a is provided with an actuation mechanism 4016a, and in one embodiment, the actuation mechanism 4016a comprises a wishbone-shaped paddle having two actuation members 4017a configured to rotate and move axially into and out of the handle 4000a. The actuation mechanism 4016a is rotated by the user to achieve a desired rotational position of the needle at the distal end of the catheter shaft. In one embodiment, the user holds the handle 4000a in the palm of the first hand. The user may use the thumb of the first hand to operate button 4010a on the surface near distal end 4004a to initiate vapor generation. In some embodiments, button 4010a is a push or rotate button having a security feature that enables a user to lock the button when operation of the button is not required. Using the thumb and index finger of the second hand, the user rotates the actuation mechanism 4016a to the desired rotational position of the needle, and then advances or retracts the needle by squeezing the actuation members 4017a of the actuation mechanism 4016a toward each other. The actuation mechanism 4016a can be released by a user to fix the position of the needle. The distal end of the catheter shaft 4006a can be advanced and retracted by moving the actuation mechanism 4016a forward and rearward at the proximal end 4002a, axially into and out of the handle 4000a.

Fig. 40B illustrates another embodiment of a catheter handle mechanism 4000B according to some embodiments of the present description. Handle 4000b is configured to operate similar to a syringe. The handle 4000b is shaped in the form of an elongated tubular structure having a rounded distal end 4004b, with a catheter shaft 4006b extending from the rounded distal end 4004 b. The proximal end 4002b of the handle is provided with an actuation mechanism 4012b, the actuation mechanism 4012b comprising a finger grip 4008b and a trigger 4016b. In some embodiments, finger grip 4008b comprises a disk at the proximal end of actuation mechanism 401 bb. In other embodiments, finger grip 4008b includes at least two arms extending from opposite sides of actuation mechanism 4012 b. The trigger 4016b extends distally of the finger grip 4008b from the body of the actuation mechanism and is configured to be pressed in a proximal direction to deploy the needle from the distal end of the catheter shaft 4006 b. The actuation mechanism 4012b further comprises a button 4010b on its proximal end to initiate vapor generation. In some embodiments, button 4010b is a push or rotate button having a security feature that enables a user to lock the button when operation of the button is not required. The actuation mechanism is also configured to be rotatable about the longitudinal axis of the handle 4000 b. The actuation mechanism 4012b is rotated by the user to rotate the needle at the distal end of the catheter shaft. A trigger 4016b extending outwardly from the actuation mechanism 4012b can be depressed downwardly by a user to advance a needle at the distal end of the catheter shaft 4006 b.

Fig. 41 illustrates another embodiment of a catheter handle mechanism 4100 according to some embodiments of the present description. The embodiment depicted in fig. 41 includes a combination of preferred functions and features in a syringe subject handle for controlling the ablation system of the specification. The figure shows two views of the handle 4100—a side horizontal view 4120 and a top perspective view 4122. The handle 4100 has a tubular structure with a proximal end 4102 and a distal end 4104 and is smoothly curved to provide an ergonomic grip to the user. A catheter shaft 4106 extends from the distal end 4104. In various embodiments, the catheter shaft 4106 extends along a longitudinal axis of the handle 4100. In some embodiments, the handle 4100 comprises a plunger mechanism 4116, the plunger mechanism 4116 comprising an elongate plunger body 4117 connected at a proximal end thereof to the paddle handle 4112, wherein a distal end of the plunger body 4117 is configured to be coaxially moveable into and out of the proximal end 4102 of the handle 4100. The user may grasp the paddle handle 4112 to push and pull the plunger body 4117 into and out of the distal end 4102 of the handle body 4109 to incrementally advance or retract the needle 4141. The paddle handle 4112 may include ridges 4113 to provide a textured grip for the user. The plunger body 4117 includes a plurality of markings 4119 to indicate to a user that the needle 4141 has been advanced a distance beyond the distal end of the catheter shaft 4106. In an embodiment, the plunger mechanism 4116 is configured to be rotated by a user, thereby rotating the plunger body 4117 within the handle body 4109 to rotate the needle 4141 at the distal end of the shaft 4106. In some embodiments, the paddle handle 4112 includes a recessed arrow 4132 and the handle body 4109 includes an angle indicator mark 4142 near its proximal end 4102 to indicate to the user the angle of rotation of the needle 4141 when the arrow 4132 and the particular mark 4142 are aligned. In an embodiment, the first strain relief 4118 is positioned at the distal end 4103 of the handle 4100 and is configured to provide support to the catheter shaft 4106 when the catheter shaft 4106 is exiting from the distal end 4104.

A first button 4110 is located on the top or first side 4107 of the handle 4100 near the distal end 4104 to initiate vapor generation. In other embodiments, the first button 4110 is positioned on the bottom or second side 4105 of the handle 4100 opposite the first side 4107. In some embodiments, the first button 4110 is a push button having a security feature that enables a user to lock the button when operation of the button is not required. In operation, the first button 4110 must first be slid forward and then pushed downward to initiate vapor generation. In an embodiment, the first button 4110 is a push and slide button configured to be pushed in and slid forward to initiate vapor generation.

In some embodiments, the catheter shaft 4106 includes a needle 4141, a soft hose end 4143, and a positioning element 4145 at its distal end, the positioning element 4145 being configured to stabilize the catheter shaft 4106 in the patient's bladder. The flexible catheter tip 4143 is configured to prevent trauma to body tissue during advancement of the catheter shaft 4106. In some embodiments, the bottom or second side 4105 of the handle 4100 includes a finger grip 4115 having the contours of the plurality of grooves 4125 and configured to provide an ergonomic grip to the user. In an embodiment, the finger grip 4115 is constructed of a material that is less rigid than the material of the handle body 4109 to provide a comfortable grip to the user. The handle 4100 further includes a fluid line 4151 extending from the proximal end of the finger grip 4115 and through the body 4109 of the handle into the catheter shaft 4106, the fluid line 4151 configured to receive a fluid for conversion to steam. The handle 4100 also includes a power cord 4153, the power cord 4153 extending from the proximal end of the finger grip 4115 through the body 4109 of the handle and into the proximal portion of the catheter shaft 4106, the power cord 4153 configured to receive an electrical current to heat an electrode positioned within the proximal portion of the catheter shaft to convert the fluid into steam for ablation. In some embodiments, a second strain relief 4128 is positioned at the proximal end of the finger grip 4115 to provide support to the infusion tube 4151 and the power cord 4153.

Fig. 42 illustrates another embodiment of a catheter handle mechanism 4200 according to some embodiments of the present description. The embodiment depicted in fig. 42 includes a combination of functions and features that are preferred in a handle having a wishbone-shaped paddle actuation mechanism for controlling the ablation system of the present specification. The figure shows two views of the handle 4200-a side horizontal view 4220 and a top perspective view 4222. The handle 4200 has a tubular structure with a proximal end 4202 and a distal end 4204, and is smoothly curved to provide an ergonomic grip to a user. A catheter shaft 4206 extends from the distal end 4204. In various embodiments, the catheter shaft 4206 extends along a longitudinal axis of the handle 4200. In some embodiments, the handle 4200 includes an actuation mechanism 4216, the actuation mechanism 4216 including two actuation mechanism arms 4217 and an adjustment stop 4212 at the proximal end 4202. In an embodiment, the actuation mechanism includes a wishbone-shaped paddle 4216, the actuation mechanism arm includes two paddle arms 4217, and the adjustment stop 4212 includes a swivel wheel. The user squeezes a pair of paddle arms 4217 with the thumb and index finger of the same hand to incrementally advance or retract needle 4241. The needle 4241 may be retracted by fully pressing the paddle arms 4217 together. Paddle 4217 may be shaped to provide an ergonomic grip between the fingers of the user. The wishbone-shaped paddle 4216 is configured to longitudinally move in and out of the proximal end 4202 of the handle body 4209 to advance and retract the catheter shaft 4206. The adjustment stop 4212 is configured to be rotated to move the adjustment stop 4212 longitudinally along the length of the actuation mechanism or wishbone-shaped paddle 4216 to the proximal end 4202, but up against the proximal end 4202, preventing further longitudinal movement of the wishbone-shaped paddle 4216, thereby locking the catheter shaft 4206 at a desired distance from the distal end 4204 of the handle 4200. In an embodiment, the user rotates wishbone-shaped paddle 4216 to rotate needle 4241 at the distal end of shaft 4206. In some embodiments, the wishbone-shaped paddle 4212 includes a concave arrow 4232 and the handle 4200 includes an angle indicator marker 4242 proximate the wishbone-shaped paddle to indicate to a user the angle of rotation of the needle 4241 when the arrow 4232 and the specific marker 4242 are aligned. In some embodiments, the handle 4200 includes a distal portion 4213 at a distal end 4204 thereof, the distal portion 4213 extending along a longitudinal axis of the handle 4200. Catheter shaft 4206 extends from distal portion 4213 along the same longitudinal axis as distal portion 4213. In an embodiment, the first strain relief 4218 is positioned at a distal end of the distal portion 4213 and is configured to provide support for the catheter shaft 4206 when the catheter shaft 4206 exits from the distal portion 4213.

A first button 4210 is located on a top or first side 4207 of the handle 4200, near the distal end 4204, to initiate vapor generation. In other embodiments, the first button 4210 is positioned on a bottom or second side 4205 of the handle 4200 opposite the first side 4207. In some embodiments, the first button 4210 is a push button having a security feature that enables a user to lock the button when operation of the button is not required. In operation, the first button 4210 must first be slid forward and then pushed downward to initiate vapor generation. In an embodiment, the first button 4210 is a push and slide button configured to be pushed in and slid forward to initiate vapor generation.

In some embodiments, catheter shaft 4206 includes a needle 4241, a soft hose end 4243, and a positioning element 4245 at its distal end, the positioning element 4245 being configured to stabilize catheter shaft 4206 in a patient's bladder. The flexible catheter tip 4243 is configured to prevent trauma to body tissue during advancement of the catheter shaft 4206. The handle also includes a fluid line 4251 extending from the proximal end 4202 of the handle and through the body 4209 of the handle into the catheter shaft 4206, the fluid line 4251 configured to receive a fluid to convert to steam. The handle 4200 also includes a power cord 4253, the power cord 4253 extending from the proximal end 4202 thereof, through the body 4209 of the handle and into the proximal portion of the catheter shaft 4206, the power cord 4253 configured to receive an electrical current to heat an electrode positioned within the proximal portion of the catheter shaft to convert the fluid into steam for ablation.

Fig. 43 illustrates another embodiment of a catheter handle mechanism 4300 in accordance with some embodiments of the present description. The embodiment depicted in fig. 43 includes a combination of preferred functions and features in a pen-subject handle for controlling the ablation system of the specification. The figure shows two views of the handle 4300-top view 4320 and top perspective view 4322. The handle 4300 has a tubular structure with a proximal end 4302 and a distal end 4304 and curves smoothly to provide an ergonomic grip for a user. A catheter shaft 4306 extends from the distal end 4304. In various embodiments, the catheter shaft 4306 extends from the distal end 4304 along a longitudinal axis of the handle 4300. In some embodiments, the handle 4300 includes a first sliding button 4316 within a track 4326 along the length of the top or first side 4307 of the handle 4300. In other embodiments, the sliding button and track are positioned along the length of the bottom or second side 4305 of the handle 4300 opposite the first side 4307. The sliding button 4316 is configured to be manually operated by a user to cause the button 4316 to slide incrementally rearward to retract a needle 4341 positioned at the distal end of the catheter shaft 4306 and slide incrementally forward to advance the needle 4341. The handle 4300 may include indicia 4317 on its body 4309 proximate to the track 4326 to indicate units of distance that are advanced or retracted by the needle 4341 by manually moving the button 4316. The sliding button 4316 may be shaped to provide an ergonomic grip under the thumb of the user when the user holds the handle 4100 with one hand. In some embodiments, the diameter of the handle 4300 at the distal portion 4313 is less than the diameter of the handle proximally along the length of its body 4309, and the handle has a tapered distal end 4304. In an embodiment, the first strain relief 4318 is positioned at the distal end of the distal portion 4313 and is configured to provide support for the catheter shaft 4306 as the catheter shaft 4306 exits from the distal portion 4313.

A second button 4310 is positioned on the topside 4307 near the distal end 4304 and is aligned with button 4316 to initiate vapor generation. In other embodiments, the second button 4310 is positioned on the bottom or second side 4305 of the handle 4300 opposite the first side 4307. In some embodiments, the second button 4310 is a push button with a security feature that enables a user to lock the button when operation of the button is not required. In operation, the second button 4310 must first be slid forward and then pushed downward to initiate vapor generation. In an embodiment, the second button 4310 is a push and slide button configured to be pushed in and slid forward to initiate vapor generation. In an embodiment, the rotating dial 4312 is included within the handle body 4309, and a portion of the rotating dial 4312 extends from the first side 4307 of the handle 4300 and is accessible to a user. In some embodiments, the rotary dial is positioned between the first sliding button 4316 and the second button 4310. In other embodiments, the rotary dial 4312 extends on the bottom or second side 4305 of the handle 4300. The rotating dial 4312 is configured to be rotated by a user to rotate the needle 4341 at the distal end of the shaft 4306. In some embodiments, the rotating dial 4312 includes a recessed arrow 4332 and the handle 4300 may include an angle indicator indicia 4342 proximate to the rotating dial 4312 to indicate to a user the angle of rotation of the needle 4341 when the arrow 4332 and the particular indicia 4342 are aligned.

In some embodiments, the catheter shaft 4306 includes a needle 4341 at its distal end, a soft condensing tip 4343, and a positioning element 4345, the positioning element 4345 being configured to stabilize the catheter shaft 4306 in the bladder of a patient. The soft catheter tip 4343 is configured to prevent trauma to body tissue during advancement of the catheter shaft 4306. The handle also includes a fluid line 4351, the fluid line 4351 extending from the proximal end 4302 of the handle and through the body 4309 of the handle into the catheter shaft 4306 configured to receive a fluid for conversion to steam. The handle 4300 further includes a power cord 4353, the power cord 4353 extending from the proximal end 4302 thereof, through the body 4309 of the handle and into the proximal portion of the catheter shaft 4306, the power cord 4353 configured to receive electrical current to heat electrodes positioned within the proximal portion of the catheter shaft to convert the fluid into steam for ablation. In some embodiments, a second strain relief 4328 is positioned at the proximal end 4302 of the handle to provide support for the fluid line 4351 and the power line 4353.

The various handle mechanisms described in the context of fig. 36A-43 may be used with any of the systems of the present specification, such as those shown in fig. 1A, 1M, 1P, 1R, 22B, 29, 30, and 31. In the different illustrated embodiments, different types of buttons or controls may be used instead of the types of buttons or controls described. For example, the type of button or control used may be selected from buttons with or without safety, a swivel wheel type control for controlling linear or circular movement, a sliding button, a toggle button, or any other type of button that may be suitable for the purpose of operating a handle according to embodiments of the present description. Additionally, the buttons may be placed on either side of the handle (left or right) to accommodate left or right handed users, or may be centered to accommodate right and left handed users.

In all of the above embodiments described in the context of fig. 36A-43, the catheter of the handle mechanism further comprises a heating chamber for generating steam or vapor for supply to the catheter. The heating chamber is activated by operating the button 3610/3710/3810/3910/4010. In some embodiments, the heating chamber is operated with RF. In some embodiments, the heating compartment comprises an electrode within the catheter shaft. The chamber is filled with water via a water inlet located at the proximal end of the handle mechanism. In embodiments, sterile water or saline is supplied from a fluid source into the handle for conversion to steam. The handle is also equipped with electrical connections to supply current from the current generator to the coil. Alternating current is supplied to the electrodes, thereby heating the electrodes in the chamber and evaporating the fluid therein. The resulting vapor or steam generated in the chamber is delivered through a needle placed at the appropriate location to ablate the target tissue. A start/stop button is provided on the handle to start or stop the ablation treatment as desired. While some embodiments have separate buttons or controls for advancing and retracting the needle, all embodiments may have separate buttons for these purposes, or once the needle is advanced to a maximum distance by repeatedly pressing the trigger for advancement, further pressing the trigger causes retraction of the needle. In all of the above embodiments, the retraction may be instantaneous, or one distance increment at a time. Additionally, in all embodiments of the handle mechanism, indicia may be placed on the handle indicating the depth of insertion of the needle. The indicia may be placed by printing, etching, painting, engraving, or by using any other means known in the art to be suitable for the purpose. The ablation needle may be inserted or retracted in fixed distance (e.g., 5 mm) increments, and the markers are accordingly placed to reflect the increments. Similar indicia may also be provided for buttons, dials, or rotating wheels for rotating the needle. The same function may be achieved by other handle form factors known in the art and also described in this application.

Handle mechanism for endometrial ablation

As previously described, fig. 17A and 17B illustrate a typical anatomy 1700 of the uterus 1706 and fallopian tubes of a human female. Fig. 18A-18X illustrate various embodiments of an ablation catheter apparatus for ablating a uterus 1706 in accordance with the present description. Referring simultaneously to fig. 17A, 17B and 18A-18X, in an embodiment, a coaxial catheter is used for insertion into a patient's vagina and advancement toward the cervix. The catheter includes an outer catheter and an inner catheter. The inner conduit is concentric with the outer conduit and has a smaller radius than the outer conduit. An electrode for heating the catheter tip is located between the two positioning elements. In some embodiments, the electrode is proximal to the proximally located element. In some embodiments, the two positioning elements are discs-a proximal disc and a distal disc, which may also be referred to as a cover or basket. The cover may be made of wires having different wire stiffness. The distal shield is configured to contact the bottom of the uterus and act as a scaffold to push the two halves of the uterus away from each other. The proximal shield is configured to close the endocervical opening. Further, fig. 19A-19P illustrate different embodiments of the positioning element and its deployment at the distal end of the catheter.

Various embodiments of a handle mechanism that may be used with an endometrial ablation device are now described. While these embodiments are useful for endometrial ablation, they can also be used with other systems of the present disclosure, such as the systems shown in fig. 1A, 1M, 1P, 1R, 22B, 29, 30, and 31. Various embodiments of the handle mechanism include a system for deployment and retraction of the positioning element, which may be implemented in different ways, such as, but not limited to, push/pull on a button, distal or proximal end, sliding button in a track, push/pull rotation. The internal components of embodiments of the handle mechanism are typically made of stainless steel. The outer components of embodiments of the handle mechanism are typically made using a combination of ABS, plastic, rigid and elastomeric polymers, and other materials. Various embodiments also provide strain relief for the rear ends of fluid pipes and cables, as well as strain relief on the front ends to provide support for the conduit sections. In various embodiments, the handles described in this specification have a length ranging from 3 inches to 24 inches and a diameter or width ranging from 1/4 inch to 5 inches.

Fig. 44A illustrates an embodiment of a handle 4400a for use with the endometrial ablation system of the specification, wherein the shape of the handle 4400a approximates a shape having an elongate cylindrical length. The figure shows a side elongated view 4400aa and a front elongated view 4400ab of a handle 4400a according to an embodiment. The handle 4400a has an elongated tubular structure with a proximal end 4402a and a distal end 4404a, wherein the distal end 4404a corresponds to the end of the handle 4400a to which the catheter shaft is attached. The tubular body of the handle 4400a has a varying diameter along its length such that the diameter along its length at the proximal end 4402a is greater than the diameter at its distal end 4404 a. In an embodiment, the tubular body is slightly oval such that a wider curved surface is available on the front and rear sides of the handle 4400a. At least two or more grooves 4406a are provided on the rear side of the handle 4400a to enable a user to ergonomically grasp the handle 4400a by resting at least two fingers in the at least two grooves. A pair of thumb wheels 4408a are located on the front of the handle, near the proximal side 4402a. Each thumb wheel 4408a corresponds to a positioning element. The thumbwheel 4408a is positioned along a length on the handle 4400a to enable a user to place a thumb on either wheel and rotate the wheel to adjust the position of the corresponding positioning element. At least one button 4410a for each wheel 4408a is located adjacent to the corresponding wheel. Button 4410a is used to lock in place the positioning elements operated by the respective wheel. The button 4410a may be on one side (left or right) of the corresponding wheel 4408a, or may be on both sides (left and right) of the corresponding wheel 4408a, such that the handle 4400a may be operated using left and right hands. In some embodiments, as shown in 4400ac, the lock buttons 4410a may be located above or below the respective wheels 4408a, wherein the wheels 4408a are positioned adjacent to each other along the width of the handle 4400a. A button 4412a is provided near the central distal end on the front side of the handle 4400a to enable a user to operate the button 4412a using their thumb or index finger to initiate the generation of steam.

Fig. 44B illustrates an embodiment of a handle 4400B for use with the endometrial ablation system of the specification, wherein the shape of the handle 4400B approximates a shape having an elongate cylindrical length. The figure shows a front elongated view 4400ba of one embodiment of the handle 4400b and a side elongated view 4400bb of another embodiment. The handle 4400b has an elongated tubular structure with a proximal end 4402b and a distal end 4404b, wherein the distal end 4404b corresponds to the end of the handle 4400b to which the catheter shaft is attached. The tubular body of the handle 4400b has a varying diameter along its length such that the diameter along its length at the proximal end 4402b is greater than the diameter at its distal end 4404 b. In an embodiment, the tubular body is slightly oval such that a wider curved surface is available on the front and rear sides of the handle 4400b. At least two or more grooves 4406b are provided on the rear side of the handle 4400b to enable a user to ergonomically grasp the handle 4400b by resting at least two fingers in the at least two grooves. A pair of sliding buttons 4408b are located on the front portion of the handle, near the proximal side 4402b. Each slide button is slidable by a thumb of the user to move along the slide rail 4410 b. A pair of slide rails 4410b provide a rail for each slide button 4408 b. The push buttons 4408b may slide within their corresponding tracks 4410b within a distance of 3mm to 10mm to position the positioning element connected to each push button 4408 b. Further, after positioning the corresponding positioning element, the button 4408b may be pressed within its track to lock the positioning element in its position. In some embodiments, the rails 4410b are parallel and positioned along the length of the handle 4400b. As shown in view 4400ba, a button 4412b is provided near the central distal end on the front side of the handle 4400a to enable a user to use their thumb or index finger to operate the button 4412b to initiate the generation of steam. In an alternative embodiment, as shown in view 4400bb, button 4412b is positioned on the rear side, proximal to proximal side 4402b of handle 4400b. Button 4412 may be a circular button, may be a triangular trigger button, or may have any other shape or configuration that provides ergonomic control for a user to operate heating of the electrode(s).

Fig. 44C illustrates an embodiment of a catheter handle mechanism 4400C according to some embodiments of the present disclosure. The shape of the handle 4400c is similar to a hand gun or pistol, which allows the physician to conveniently manipulate the handle 4400c to perform an ablation treatment. The handle 4400c includes a first portion 4402c and a second portion 4404c, the first portion 4402c and the second portion 4404c being coupled together at an angle in the range of 0 to 180 degrees relative to one another such that the first portion 4402c is configured to be held in a user's hand and the second portion 4404c extends from an end of the first portion 4402c and includes a catheter shaft extending from the first portion 4402 c. The strain relief may be configured to provide support to a catheter shaft positioned at the distal end of the second portion 4404 c. As explained in the embodiments above, the positioning elements are coupled to the catheter shaft and one or more steam ports between the positioning elements are used to deliver steam or vapor to the target tissue. In an embodiment, the first portion 4402c may be provided with a friction grip to secure the user's grip. In an embodiment, a button 4412c is provided on the top edge of the second portion 4404c to initiate vapor generation. In some embodiments, button 4412c is a push button having a safety feature that enables a user to lock the button when operation of the button is not required. A pair of triggers 4408c are disposed at the bottom edge of the second portion 4404 c. Each trigger 4408c corresponds to a positioning element in the catheter shaft. Pulling the trigger moves the corresponding positioning element a distance. The positioning element is held in its position when the corresponding trigger is not operated.

Fig. 44D illustrates an embodiment of a catheter handle mechanism 4400D according to some embodiments of the present description. The figure shows a side view 4400da and a rear view 4400db of a handle 4400d according to some embodiments. The shape of the handle 4400d is similar to a hand gun or pistol, which allows the physician to conveniently manipulate the handle 4400d to perform an ablation treatment. The handle 4400d includes a first portion 4402d and a second portion 4404d, the first portion 4402d and the second portion 4404d being coupled together at an angle in the range of 0 to 180 degrees relative to each other such that the first portion 4402d is configured to be held in a user's hand and the second portion 4404d extends from an end of the first portion 4402d and includes a catheter shaft extending from the first portion 4402 d. The strain relief may be configured to provide support to a catheter shaft positioned at the distal end of the second portion 4404 d. As explained in the embodiments above, the positioning elements are coupled to the catheter shaft and one or more steam ports between the positioning elements are used to deliver steam or vapor to the target tissue. In an embodiment, the first portion 4402d may be provided with a friction grip to secure the user's grip. A pair of thumb wheels 4408d and 4409d are provided to control the movement and placement of the positioning elements, respectively. In some embodiments, the first thumb wheel 4408d is disposed on the rear side along the length of the first portion 4402 d. In one embodiment, the thumb wheel 4408d controls the proximal positioning element and the second thumb wheel 4409d controls the distal positioning element. In an alternative embodiment, the thumb wheel 4408d controls the distal positioning element and the thumb wheel 4409d controls the proximal positioning element. The thumb wheel 4409d is positioned along the top edge of the second portion 4404 d. The button 4410d accompanies the thumb wheel 4408d and is configured to lock the position of the corresponding positioning element upon operation. The lock button 4410d may be positioned adjacent to the thumb wheel 4408d, such as below the thumb wheel 4408d as shown. Similarly, a button 4411d accompanies the thumb wheel 4409d and is configured to lock the position of the corresponding positioning element upon operation. The lock button 4411d may be positioned adjacent to the thumb wheel 4409d, such as behind the thumb wheel 4409d as shown. In an embodiment, a trigger pull 4412d positioned along the bottom edge of the second portion 4404d is provided to initiate vapor generation. In some embodiments, button 4412d is pulled to initiate ablation therapy and generate steam/vapor, and released to stop therapy.

Fig. 44E illustrates a portion 4404E of a handle mechanism 4400E according to some embodiments of the present disclosure. The handle 4400e may be shaped like a hand gun or pistol, or may have a tubular elongate length that allows the physician to conveniently manipulate the handle 4400e to perform an ablation treatment. The handle 4400e includes a first portion (not shown) and a second portion 4404e, the first and second portions 4404e being coupled together at an angle in the range of 0 to 180 degrees relative to each other such that the first portion is configured to be held in a user's hand and the second portion 4404e extends from an end of the first portion and includes a catheter shaft extending therefrom. The figure shows a top view of the second portion 4404e. In some alternative embodiments, the components shown in the figures are disposed along the edges of the first portion 4402 e. The top edge of the second portion includes a sliding button disposed within sliding track 4420 e. The sliding button may be slid forward or backward by the user for corresponding retraction of the catheter shaft. Visual indicators 4422e are positioned along the top edge of the second portion 4404e in front of the tracks 4420 e. Indicator 4422e is configured to provide a color, line, or any other visual indicator to show the degree of separation between the positioning elements on the catheter shaft. A locking knob 4424e is also provided along the top edge of the second portion 4404e to lock the catheter shaft in place. In some embodiments, locking knob 4424e is a T-B type locking knob.

Fig. 44F illustrates another embodiment of a handle mechanism 4400F for an endometrial ablation system according to some embodiments of the specification. The shape of the handle 4400f is similar to a hand gun or pistol, which allows the physician to conveniently manipulate the handle 4400f to perform an ablation treatment. The handle 4400f includes a first portion 4402f and a second portion 4404f, the first portion 4402f and the second portion 4404f being coupled together at an angle in the range of 0 to 180 degrees relative to one another such that the first portion 4402f is configured to be held in a user's hand and the second portion 4404f extends from an end of the first portion 4402f and includes a catheter shaft 4430f extending from the first portion 4402 f. The shaft 4430f is configured to pass through an opening 4432f at a proximal edge of the second portion 4404f and to emerge through a distal end of the second portion 4404 f. The user can manually push or pull the catheter shaft 4430f before the opening 4432f to push or pull the catheter shaft 4430f for deployment. The inner catheter sheath 4434f is coaxially positioned within the catheter shaft. The positioning element is attached to the inner catheter sheath 4434f as described in the previous embodiments. Knob 4436f is disposed along a bottom edge of second portion 4404 f. A portion of knob 4436f is within the body of second portion 4404f and is in communication with inner catheter sheath 4434 f. The other portion of the knob is external to the body of the second portion 4404f, which can be rotated by a user to move the inner catheter 4434f and thus the positioning element attached to the inner catheter 4434 f. In an embodiment, the friction lock is configured with a knob 4436f such that the inner catheter sheath 4434f is locked in place when not in operation. In an embodiment, a button 4412f is provided positioned along the proximal corner edge of the second portion 4404f to initiate vapor generation. In some embodiments, button 4412f is pressed to initiate ablation therapy and generate steam/vapor, and released to stop therapy.

Fig. 44G illustrates a cross-sectional view of another embodiment of a handle mechanism 4400G for an endometrial ablation system according to some embodiments of the specification. The handle mechanism 4400g has a proximal 4402g and a distal 4404g, the proximal 4402g and the distal 4404g forming a linear tubular structure that is bulbous in the center for a user to grasp the handle during use. The proximal side 4402g is configured to be held in a user's hand, and the distal side 4404g extends linearly from the proximal side 4402g and includes a catheter shaft 4420g extending therefrom. Slider button 4422g is configured along the top surface of handle 4400 g. The push button 4422g is used to retract the outer catheter shaft 4420g such that an inner catheter lumen comprising at least two positioning elements (proximal positioning element 4424g and distal positioning element 4426 g) is deployed at the distal end of the shaft 4420g. At the proximal edge of the proximal side 4402g of the handle 4400g, a lumen including a proximal positioning element 4424g has an externally threaded surface 4428g. The surface 4428g also engages with an internally threaded surface 4430g within the handle 4400 g. The internally threaded surface 4430g is further attached at its proximal side to a threaded knob 4432g external to the proximal side 4402g of the handle 4400 g. Thus, when the user rotates the knob, the surface 4428g that engages the knob 4432g enables the proximal positioning element 4424g to move relative to the distal positioning element 4426 g. Knob 4432g provides a means for fine tuning the distance between proximal positioning element 4424g and distal positioning element 4426 g.

Fig. 44H illustrates another embodiment of a handle mechanism 4400H for use with an endometrial ablation system according to some embodiments of the specification. The handle 4400h includes two portions, a proximal portion 4402h and a distal portion 4404h, which are linearly connected to one another. In some embodiments, the proximal portion 4402h is cylindrical in shape and curves smoothly to provide an ergonomic grip to the user. A cable 4430h including one or more wires for connecting the handle 4400h to at least one of power and saline or fluid for ablation is configured to enter the handle 4400h at the proximal end of the proximal portion 4402 h. The strain relief 4432h may be configured to provide support to a catheter shaft 4430h positioned at the proximal end of the proximal portion 4402 h. Further, the surface of the cylindrical body of the proximal portion 4402h includes a button 4412h, which button 4412h is configured to initiate vapor generation. In some embodiments, button 4412h is a push button, or a slide button that is operated by a user to initiate ablation therapy by generating steam/vapor. The rotating ring 4434h is disposed at the distal circular edge of the proximal portion 4402 h. The ring 4434h is configured to be rotatable by a user to lock. The distal portion 4404h extends along the same central horizontal axis as the central horizontal axis of the proximal portion 4402 h. The distal portion 4404h is also cylindrical in shape and has a diameter that is smaller than the diameter of the proximal portion. The catheter sheath 4420h extends from the distal end of the distal portion 4404 h. The sheath 4420h contains a coaxial inner catheter lumen 4422h therein. Lumen 4422h also has proximal and distal positioning elements 4424h and 4426h attached toward the distal end thereof. The distal portion 4404h includes at least two circular dials disposed on an outer surface thereof. The first dial 4436h is attached to the proximal positioning element 4424h and can be rotated or pushed/pulled in a direction along the horizontal axis of the distal portion 4404h to position the proximal positioning element 4424h at a distance relative to the distal positioning element 4426h. The second dial 4438h may be positioned distally relative to the first dial 4436h and a distance from the first dial 4436 h. The second dial 4438h is configured to be rotated by a user to displace the catheter 4420h to deploy one or more positioning elements 4424h/4426h over the lumen 4422h.

Fig. 44I and 44J illustrate another embodiment of a handle mechanism 4400h for use with an endometrial ablation system according to some embodiments of the specification. The embodiment depicted in fig. 44I and 44J includes a combination of preferred features in the linear handle 4400I for controlling the endometrial ablation system of the specification. Fig. 44J shows a top perspective view 4400ja and a top view 4400jb of two view-lateral first side 4440i of the handle 4400 i. Referring to both fig. 44I and 44J, the handle 4400I has a tubular structure with a proximal end 4402I and a distal end 4404I, and the handle 4400I is smoothly curved to provide an ergonomic grip to the user. The catheter shaft 4420i extends from the distal end 4404 i. In various embodiments, the catheter shaft 4420i extends from the distal end 4404i along a longitudinal axis of the handle 4400 i. In some embodiments, the handle 4400i includes a first button 4412i on a portion proximate to the distal end 4404i and positioned on a lateral first side 4440i of the handle 4400 i. The first button 44121 is configured so that a user's finger can slide the button while also grasping the grip with the remaining fingers of the same hand. In an embodiment, button 4412i is used to control vapor generation. In some embodiments, button 4412i is a push button having a security feature that enables a user to lock the button when operation of the button is not required. In operation, button 4412i must first slide forward and then be pushed downward to initiate vapor generation. In an embodiment, button 4412i is a push and slide button configured to be pushed in and slid forward to initiate vapor generation. In an embodiment, the first strain relief 4430i is positioned at the distal end of the distal portion 4404i and is configured to provide support to the catheter shaft 4420i as the catheter shaft 4420i exits from the distal portion 4404 i.

In an embodiment, the handle 4400i includes a second button 4406i on a portion proximate the proximal end 4402i and positioned on the lateral first side 4440 i. The second button 44061 is configured for a user to slide the button while also grasping the grip 4400i with the remaining fingers of the same hand. The button 4406i is used to operate the opening and closing of a proximal positioning element 4442i located at the distal end of the catheter shaft 4420i, the proximal positioning element 4442i being proximal to the atraumatic tip 4446 i. The soft atraumatic tip 4446i is configured to be atraumatic to body tissue during advancement of the catheter shaft 4420 i. In an embodiment, the handle 4400i further includes a third button 4408i on a portion proximate the proximal end 4402i and positioned on the lateral first side 4440 i. The third button 4408i is configured for a user to slide the button while also grasping the grip 4400i with the remaining fingers of the same hand. The button 4408i is used to operate the opening and closing of the distal positioning element 4444i distal to the proximal positioning element 4442i at the distal end of the catheter shaft 4420 i. In some embodiments, as shown in views 4400ja and 4400jb of fig. 44I and 44J, the second button 4406I is nested within the third button 4408I. In an alternative embodiment, as shown in view 4400jc, the second button 44061 and the third button 44081 are parallel to each other on the lateral first side 44401. The window 4410i is located on the lateral first side 44401 on the distal side of the second button 44061 and the third button 44081 and on the proximal side of the first button 44121. Window 4410i may be a square, circular, or any other shaped window that provides a visual indicator of the degree of separation between proximal positioning element 4442i and distal positioning element 4444 i. In some embodiments, the marked scale 4409i within window 4410i shows the degree of separation. In some embodiments, window 4410i includes a degree indicator tab 4409i and includes a recessed arrow 4411i on handle 4400i proximate window 4410i to indicate to a user the degree of separation between positioning elements 4442i and 4444i when arrow 4411i and specific tab 4409i are aligned.

In an embodiment, the swivel rod 44161 is included on the lateral first side 44401, proximal of the first button 44121, and distal of the window 44101. The rotating lever 4416i is configured to be rotatable from one side of the positioning element 4442i/4444i locked in position to the other side of the positioning element 4442i/4444i unlocked. The rotating lever 4416i is configured to be rotatable along the circumference of the tubular handle 4400 i. In some embodiments, rotating the lever 4416i is accompanied by graphical indicators 4418i and 4419i printed on either side of the rotational path of the lever 4416i, which guide the user to the locked and unlocked positions, respectively.

The handle 4400i further includes a fluid line 4434i extending from the proximal end 4402i thereof and through the body of the handle 4400i into a catheter shaft 4420i, the catheter shaft 4420i being configured to receive a fluid for conversion to steam. The handle 4400i further includes a power cord 4436i extending from a proximal end 4402i thereof through the body of the handle 4400i and into a proximal portion of the catheter shaft 4420i, the power cord 4436i being configured to receive electrical current to heat electrodes positioned within the catheter shaft 4420i to convert fluid into steam for ablation. In some embodiments, a second strain relief 4432i is positioned at the proximal end 4402i of the handle 4400i to provide support for the infusion tube 4434i and the power cord 4436 i.

Fig. 44K illustrates yet another embodiment of a handle mechanism 4400K for use with an endometrial ablation system according to some embodiments of the specification. The handle 4400k is linear in shape and includes a proximal portion 4402k and a distal portion 4404k. The catheter shaft extends from the distal end of the distal portion 4404k. The handle 4400k further includes a fluid line 4434k extending from the proximal end 4402k thereof and through the body of the handle 4400k into the catheter shaft, the fluid line 4434k being configured to receive a fluid for conversion to steam. The handle 4400k further includes a power cord 4436k extending from a proximal end 4402k thereof through the body of the handle 4400k and into a proximal portion of the catheter shaft, the power cord 4436k being configured to receive electrical current to heat electrodes positioned within the catheter shaft to convert fluid into steam for ablation. In some embodiments, a first strain relief 4430k is positioned at the proximal end 4402k of the handle 4400k to provide support for the infusion tube 4434k and the power cord 4436 k. A second strain relief 4432k is disposed at the distal end of the distal portion 4404k to provide support to the catheter shaft.

The handle 4400k is generally tubular in shape with a first lateral side 4420. The second side and the third side are adjacent to the first side, each side being at an angle of 90 degrees to the first side and opposite each other. The figure shows a top view 4400ka showing a first side 4420k of the handle 4400k and a side view 4400kb showing a portion of a second/third side of the handle 4400 k. The first rotating dial 4406k is configured on the first side, proximate to the center portion of the handle 4400 k. The first rotary dial 4406k is used to operate the opening and closing of the proximally located element. The second rotating dial 4408k is also disposed on the first side adjacent to the first rotating dial 4406k near the center portion of the handle 4400 k. The second rotary dial 4408k is used to operate the opening and closing of the distally located elements. In some embodiments, the perimeter of the first rotating disk 4406k is less than the perimeter of the second rotating disk 4408 k. In an embodiment, the second rotary dial 4408k is disposed between the first rotary dial 4406 k. The switch button 4416k switches between the second lateral side and the third lateral side on either side of the rotary dials 4406k and 4408 k. The switch button 4416k is used to lock and unlock the position of the bit element. In addition, a first side 4420k on the surface of the handle 4400k between the rotary dial 4406k/4408k and the distal end 4404k includes a button 4412k, the button 4412k being configured to initiate vapor generation. In some embodiments, button 4412k is a push button, or a slide button that is operated by a user to initiate ablation therapy by generating steam/vapor.

Fig. 44L and 44M illustrate another embodiment of a handle mechanism 4400L for use with an endometrial ablation system according to some embodiments of the specification. The embodiment depicted in fig. 44L and 44M includes a combination of preferred features in a flat linear handle 4400L for controlling the endometrial ablation system of the specification. Fig. 44M shows a top perspective view 4400ma and a top view 4400mb of two view-lateral first side 4440l of the handle 4400 l. Referring to both fig. 44L and 44M, the handle 4400L has a flat spatula-like structure. The first lateral side 4440l has a flat surface while the bottom side opposite the first lateral side 4440l is largely planar with a smooth rounded edge connecting the first planar side 4440l to provide a smooth and ergonomic grip to the user. The handle 4400l has a proximal end 4402l and a distal end 4404l. Distal end 4404l has a second, larger width relative to the first, smaller width of proximal end 4402 l. The first width extending from the proximal end 4402l toward the distal end 4404l is the same for most of the length of the handle, and then increases to the second width when the length of the handle 4400l is proximal to the distal end 4404l. The width of the handle 4400l varies along its length to provide it with a shape similar to a spoon or spatula. A catheter shaft 4420l extends from the distal end 4404l. In various embodiments, the catheter shaft 4420l extends from the distal end 4404l along a longitudinal axis of the handle 4400 l. In some embodiments, the handle 4400l includes a first button 4412l, the first button 4412l being on a relatively wide portion proximate the distal end 4404l and positioned on a lateral first side 4440l of the handle 4400 l. The first button 4412l is configured such that the user's thumb can slide the button while also grasping the grip with the remaining fingers of the same hand. In an embodiment, button 4412l is used to control vapor generation. In some embodiments, button 4412l is a push button having a security feature that enables a user to lock the button when operation of the button is not required. In operation, button 4412l must first be slid forward and then pushed downward to initiate vapor generation. In an embodiment, button 4412l is a push and slide button configured to be pushed in and slid forward to initiate vapor generation. In an embodiment, the catheter shaft 4420l is fixedly attached to the distal end 4404l.

In an embodiment, the handle 4400l includes a second button 4406l and a third button 4408l, the second button 4406l and the third button 4408l being slidable along their respective slide rails 4414l and 4416 l. View 4400mc shows a larger view of the slide rail 4414l/4416l and the push button 4406l/4408 l. The rails 4414l/4416l extend along the length of the handle 4400l over a portion of the first width. The slide buttons 4406l/4408l are configured to slide from their respective tracks 4414l/4416l while the user grips the handle 4400l with the remaining fingers of the same hand. Buttons 4406l and 4408l are used to deploy and retract proximal positioning element 4442l and distal positioning element 4444l, respectively. The proximal positioning element 4442l and the distal positioning element 4444l are located at the distal end of the catheter shaft 4420 l. Proximal positioning element 4442l is located proximal to atraumatic tip 4446 l. The soft atraumatic tip 4446l is configured to be atraumatic to body tissue during advancement of the catheter shaft 4420 l. In an embodiment, the two rails 4414l and 4416l extend parallel to each other along the same length on the first lateral side 4440 l. Each rail 4414l and 4416l includes an equal number of recesses. The rail 4414l includes a recess 4415l, and the rail 4416l includes a recess 4417l. Each recess in the track is equally spaced. In one embodiment, rails 4414l and 4416l each have five recesses 4415l and 4417l, respectively. In operation, as a user slides the buttons 4406l and 4408l, the buttons rest within recesses in their tracks, thereby providing incremental positioning of the positioning elements 4442l and 4444l. At rest, button 4406; and 4408l locking the position of the corresponding positioning element. Recesses 4415l and 4417l also indicate the extent of deployment of the respective positioning elements. The positions of the buttons 4406l and 4408l indicate the relative distance between the two positioning elements. In an embodiment, a graphic or text symbol 4422l is printed or embossed at the end of each track to show whether the track corresponds to a distally or proximally located element. Thus, embodiments of the handle mechanism 4400l provide independent slides for deploying the two positioning elements.

The handle 4400l also includes a fluid line 4434l extending from the proximal end 4402l thereof and through the body of the handle 4400l into a catheter shaft 4420l, the catheter shaft 4420l being configured to receive a fluid for conversion to steam. The handle 4400l also includes a power cord 4436l extending from a proximal end 4402l thereof through the body of the handle 4400l and into a proximal portion of the catheter shaft 4420l, the power cord 4436l being configured to receive electrical current to heat electrodes positioned within the catheter shaft 4420l to convert fluid into steam for ablation. In some embodiments, a strain relief 4430l is positioned at the proximal end 4402l of the handle 4400l to provide support for the fluid line 4434l and the power line 4436 l.

Fig. 44N illustrates another embodiment of a handle mechanism 4400N for use with an endometrial ablation system according to some embodiments of the specification. The handle 4400n is linear in shape and includes a proximal end 4402n and a distal end 4404n. A catheter shaft 4420n extends from the distal end 4404n. The handle 4400n includes a fluid and a power cord extending from its proximal end 4402n and through the body of the handle 4400n into a catheter shaft 4420n, the catheter shaft 4420n being configured to receive the fluid and power to heat the electrode for conversion to steam. In some embodiments, strain relief is provided on the proximal end 4402 to support fluid and power lines. Similarly, strain relief may be provided at the distal end 4404n to provide support for the catheter shaft 4420 n.

The handle 4400n is generally cylindrical in shape. The circular sleeve 4406n is coaxially disposed on an outer surface surrounding the handle 4400n proximate a central portion along the length of the handle 4400 n. The circular sleeve 4406n is used to manipulate deployment of both proximal and distal positioning elements at the distal end of the catheter shaft 4420 n. In operation, the user slides the sleeve toward the distal end 4404n to deploy the two positioning elements and in the opposite direction to retract the positioning elements. In an embodiment, the two positioning elements are separated by a distance of about 3.5mm, which is maintained during their deployment using the sleeve 4406 n. The deployed position is locked when the sleeve is stationary. The friction lock is effective during deployment. In addition, the rotating dial 4408n is also coaxially disposed on the outer surface around the handle 4400n, proximal to the proximal end 4402n, and between the proximal end 4402n and the sleeve 4406 n. The rotating dial 4408n may be rotated by a user in one direction to incrementally drive the distal positioning element away from the proximal positioning element. In one embodiment, the distal positioning element may be driven to a distance of 10mm from the proximal positioning element. Rotating the dial 4408n may retract the distal positioning element from the proximal positioning element to its original distance (e.g., 3.5mm as described above). In addition, a button 4412n is disposed on the outer surface of the handle 4400n distal to the sleeve 4406n and proximate to the distal end 4404n. A button 4412n is provided to initiate vapor generation. In some embodiments, button 4412n is a push button, a rotary dial, a circular sleeve, or a sliding button that is operated by a user to initiate ablation therapy by generating steam/vapor.

Fig. 44O illustrates an embodiment of a catheter handle mechanism 4400O according to some embodiments of the present description. The shape of the handle 4400o is similar to a hand gun or pistol, which allows the physician to conveniently manipulate the handle 4400o to perform an ablation treatment. The handle 4400o includes a first portion 4402o and a second portion 4404o, the first portion 4402o and the second portion 4404o being coupled together at an angle in the range of 0 to 180 degrees relative to each other such that the first portion 4402o is configured to be held in a user's hand and the second portion 4404o extends from an end of the first portion 4402o and includes a catheter shaft extending from the first portion 4402 o. The strain relief may be configured to provide support to a catheter shaft positioned at the distal end of the second portion 4404 o. As explained in the embodiments above, the positioning elements are coupled to the catheter shaft and one or more steam ports between the positioning elements are used to deliver steam or vapor to the target tissue. In an embodiment, the first portion 44020 is provided with a first trigger 44060. The first trigger 4406o is positioned along an inner length of the first portion 4402o, wherein the inner length is the length of the first portion 4402o forming an angle with the second portion 4404o of between 0 and 180 degrees. In operation, a user pulls the first trigger 44060 to deploy at least two positioning elements at the distal end of the catheter shaft. In some embodiments, the two positioning elements are deployed at a fixed distance from each other. The rotating dial 4408o is disposed at the outer corner of the joint between the first portion 4402o and the second portion 4404 o. The rotating dial 44080 is operated by a user to adjust the distance between two positioning elements deployed at the distal end of the catheter. Rotating the dial 4408o may drive the distal positioning element farther away from the proximal positioning element up to a particular length. In one embodiment, the distal positioning element is driven to a distance of 10mm from the proximal positioning element. In an embodiment, a second trigger 4412o is provided to initiate vapor generation, the second trigger 4412o being positioned near an interior angle of the joint between the first portion 4402o and the second portion 4404o and along an interior length of the first portion 4402 o. In some embodiments, button 4412o is a push button having a security feature that enables a user to lock the button when operation of the button is not required.

Fig. 44P illustrates an embodiment of a catheter handle mechanism 4400P according to some embodiments of the present disclosure. The handle mechanism 4400p includes cam locks 4401p, 4402p for deploying, retracting and locking the distal and proximal positioning elements of the ablation catheter.

Fig. 44Q and 44R illustrate another embodiment of a handle mechanism 4400Q for use with an endometrial ablation system according to some embodiments of the specification. The embodiment depicted in fig. 44Q is largely similar to the embodiment depicted and described in fig. 44I and 44J. For brevity, the description of these embodiments will not be repeated here. Fig. 44Q shows a single view of the handle 4400Q. The handle 4400q includes a vapor line 4401q and a power line 4402q. Thumb slide 4403q is included to control the delivery of steam or vapor. The first independent slider 4404q controls the deployment, retraction, and positioning of the first distal positioning element or cap 4414q, and the second independent slider 4405q controls the deployment, retraction, and positioning of the second proximal positioning element 4415 q. The first set of incremental distal positioning elements or cap indicators 4424q indicate the distance that the first distal positioning element or cap 4414q has been extended. A second set of incremental proximal positioning elements or cap indicators 4425q indicate the distance that the second proximal positioning element or cap 4415q has been extended. Fig. 44R shows two views of the handle 4400R. The first view 4400ra is a perspective view of the handle 4400r in a first arrangement; and the second view 4400rb is a perspective view of the handle 4400r in the second arrangement. The handle 4400r is generally split into two portions-a first proximal portion 4452r including a proximal end 4402r and a second distal portion 4454r including a distal end 4404 r. In an embodiment, the button 4412r is also included on the first lateral side 4440r in the second distal section 4454r. However, the remaining interfaces on the first lateral side 4440r of the handle 4400r (such as including the rotating lever 4416r, the window 4410r, and the buttons 4406r and 4408 r) are included in the first proximal section 4452 r. The handle 4400r also shows a second side 4448r and a third side 4450r, each adjacent to the first side 4440r and parallel and opposite each other. A side lock button 4456r is disposed at the distal end of the first proximal section 4452r distal to the swivel lever 4416 r. Button 4456r is configured as a button that a user can access to press with a thumb or finger while holding handle 4400r with the remaining fingers of the same hand. The button 4456r is accessible on both the second side 4448r and the third side 4450 r. In operation, the user presses button 4456r to change the angle between the first and second proximal segments 4452r, 4454r. The first section 4452r and the second section 4454r are attached to each other and rotatable relative to each other. The first view 4400ra shows the arrangement between the first section 4452r and the second section 4454r when the first section 4452r and the second section 4454r are linear at an angle of 180 degrees relative to each other. The second arrangement 4400rb shows two sections 4452r and 4454r angled relative to each other. The user obtains the angled position by pressing button 4456r to disengage the lock attaching the two sections 4452r and 4454r in the locked position. The user may then manually rotate the second section 4454r to angle it relative to the first section 4452 r. Button 4456r may be pressed again to lock the final angled arrangement.

It should be noted that the various embodiments described in the context of fig. 44A-44R may use features and configurations of each other. In some embodiments, the structure and shape of the handle may be any of the structures and shapes depicted in the figures. Similarly, the combination of control types (buttons, sliders, wheels, levers or triggers) for initiating vapor generation, the operation of the positioning element may be selected from different embodiments.

The various handle mechanisms described in the context of fig. 44A-44R may be used with any of the systems of the present specification, such as those shown in fig. 1A, 1M, 1P, 1R, 22B, 29, 30, and 31. In the different illustrated embodiments, different types of buttons or controls may be used instead of the types of buttons or controls described. For example, the type of button or control used may be selected from buttons with or without safety, a swivel wheel type control for controlling linear or circular movement, a sliding button, a toggle button, or any other type of button that may be suitable for the purpose of operating a handle according to embodiments of the present description. Additionally, the buttons may be placed on either side of the handle (left or right) to accommodate left or right handed users, or may be centered to accommodate right and left handed users.

In all of the above embodiments described in the context of fig. 44A-44R, the conduit of the handle mechanism further comprises a heating chamber for generating steam or vapor for supply to the conduit. The heating chamber is started by operating the button 4412. In some embodiments, the heating chamber is operated with RF. In some embodiments, the heating compartment comprises an electrode within the catheter shaft. The chamber is filled with water via a water/fluid inlet at the proximal end of the handle mechanism. In embodiments, sterile water or saline is supplied from a fluid source into the handle for conversion to steam. The handle is also equipped with electrical connections to supply current from the current generator to the coil. Alternating current is supplied to the electrodes, thereby heating the electrodes in the chamber and evaporating the fluid therein. The resulting vapor or steam generated in the chamber is delivered through a vapor port or at least one aperture disposed between two positioning elements. A start/stop button is provided on the handle to start or stop the ablation treatment as desired. While some embodiments have separate buttons or controls for advancing and retracting each positioning element, all embodiments may have separate buttons for these purposes. In all of the above embodiments, the retraction may be instantaneous, or one distance increment at a time. Additionally, in all embodiments of the handle mechanism, indicia may be placed on the handle indicating the extent of advancement of the positioning element and the distance between the two positioning elements. The indicia may be placed by printing, etching, painting, engraving, or by using any other means known in the art to be suitable for the purpose. Similar indicia may also be provided for buttons, dials, or rotating wheels for rotating the needle. The same function may be achieved by other handle form factors known in the art and also described in this application.

In an embodiment, a microwave-based ablation system and method are used. Thus, microwaves are used instead of electrodes to deliver energy to produce steam. In embodiments described below, an ablation system includes a catheter having a heating element that includes at least one microwave antenna. The microwave antenna is configured to receive an electrical current and generate heat to convert fluid passing through the antenna into steam for ablation.

Fig. 45 illustrates an ablation system 4500 according to an embodiment of the present disclosure. The ablation system includes a catheter 4510, the catheter 4510 having at least one first distal attachment or positioning element 4511 and an internal heating chamber 4518, the internal heating chamber 4518 being disposed within a lumen of the catheter 4510 and configured to heat a fluid provided to the catheter 4510 to change the fluid to steam for ablation therapy. In some embodiments, the internal heating compartment 4518 comprises at least one microwave antenna separated from the thermally conductive element by a non-conductive section of the conduit 4510. In some embodiments, the catheter 4510 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. Catheter 4510 includes one or more infusion ports 4512 for infusing ablative agents (e.g., vapors). In some embodiments, the one or more infusion ports 4512 comprise a single infusion port at the distal end of the needle. In some embodiments, the catheter includes a second positioning element 4513 proximal to the infusion port 4512. In various embodiments, the first distal attachment or positioning element 4511 and the second positioning element 4513 may be any of a disc, cap, or expandable balloon. In some embodiments, the distal attachment or positioning element has a wire mesh structure with or without a cover film. In some embodiments, the first distal attachment or positioning element 4511 and the second positioning element 4513 comprise holes 4519 for air or ablative agent to escape. A fluid, such as saline, is stored in a reservoir (such as saline pump 4514) connected to conduit 4510. Delivery of the ablative agent is controlled by controller 4515 and treatment is controlled by the treating physician via controller 4515. The controller 4515 includes at least one processor 4523 in data communication with the brine pump 4514 and a conduit connection port 4521 in fluid communication with the brine pump 4514. In some embodiments, at least one optional sensor 4517 monitors changes in the ablation region to direct the flow of the ablative agent. In some embodiments, optional sensor 4517 comprises at least one of a temperature sensor or a pressure sensor. In some embodiments, conduit 4510 includes a filter 4516 having micropores that provides a back pressure to the vapor delivered, thereby pressurizing the vapor. The predetermined size of the micropores in filter 4516 determines the backpressure and, therefore, the temperature of the vapor being generated. In some embodiments, the system further comprises a foot pedal 4525 in data communication with the controller 4515, a switch 4527 on the conduit 4510, or a switch 4529 on the controller 4515 for controlling steam flow. In various embodiments, the switch 4529 is positioned on the generator or catheter handle.

In one embodiment, a user interface included with the controller 4515 allows a physician to define devices, organs, and conditions, which in turn creates default settings for temperature, circulation, volume (sound), and standard RF settings. In one embodiment, these default values may be further modified by the physician. The user interface also includes a standard display of all key variables, as well as warnings if the value exceeds or falls below a certain level.

Fig. 46 and 47 illustrate multi-lumen balloon catheters 4661 and 4671, respectively, according to embodiments of the present disclosure. The catheters 4661, 4771 each include an elongated body 4662, 4772 having a proximal end and a distal end. The catheters 4661, 4771 include at least one positioning element near their distal ends. In various embodiments, the positioning element is a balloon. In some embodiments, the catheter includes more than one positioning element.

In the embodiment depicted in fig. 46 and 47, the catheters 4661, 4771 each include a proximal balloon 4666, 4776 and a distal balloon 4668, 4778, the proximal and distal balloons 4666, 4776, 4668, 4778 being positioned near the distal ends of the bodies 4662, 4772, with a plurality of infusion ports 4667, 4777 located on the bodies 4662, 4772 between the two balloons 4666, 4776 and 4668, 4778. The body 4662, 4772 also includes at least one heating compartment 4630 adjacent to the proximal balloon 4666, 4776 and just proximal to the proximal balloon 4666, 4776. Each heating compartment 4630/4730 includes at least one microwave antenna for generating heat. The embodiment of fig. 46 shows one heating compartment 4630 included in the main body 4665, the heating compartment 4630 being proximal to the proximal balloon 4666 and just proximal to the proximal balloon 4666. In some embodiments, a plurality of heating chambers are arranged in series in the body of the conduit.

In the embodiment of fig. 47, two heating compartments 4730 are disposed in the body 4772 proximate to the proximal balloon 4776 and just proximal to the proximal balloon 4776. Referring to fig. 47, to expand the bladders 4776, 4778 and provide current and liquid to the conduit 4771, a fluid pump 4779, an air pump 4773, and an RF generator 4784 are coupled to the proximal end of the body 4772. The air pump 4773 pumps air through a first lumen (extending along the length of the body 4772) via a first port to expand the bladders 4776, 4778 such that the conduit 4771 is held in place for ablation therapy. In another embodiment, the catheter 4771 includes additional air ports and additional air chambers so that the balloons 4776, 4778 may be inflated individually. The fluid pump 4779 pumps fluid through a second lumen (extending along the length of the body 4772) to the heating compartment 4730. The RF generator 4784 supplies current to at least one microwave antenna to cause the at least one microwave antenna to generate heat, thereby converting fluid flowing through the heating chamber 4730 to steam. The generated vapor flows through the second lumen and exits port 4777. The flexible heating lumen 4730 imparts improved flexibility and maneuverability to the catheters 4661, 4771, allowing a physician to better position the catheters 4661, 4771 when performing an ablation procedure, such as ablating Barrett's esophageal tissue in a patient's esophagus.

Fig. 48 shows a catheter 4891 with proximal and distal positioning elements 4896, 4898 and one or more microwave antenna based heating compartments 4830 according to an embodiment of the present disclosure. The catheter 4891 includes an elongated body 4892 having a proximal end and a distal end. The catheter 4891 includes a proximal positioning element 4896 and a distal positioning element 4898, with the proximal positioning element 4896 and the distal positioning element 4898 positioned near the distal end of the body 4892, with a plurality of infusion ports 4897 located between the two positioning elements 4896, 4898 on the body 4892. Body 4892 also includes at least one heating compartment 4830 within the central lumen. In some embodiments, the proximal and distal positioning elements 4896, 4898 comprise compressible disks that expand upon deployment. In some embodiments, the proximal and distal positioning elements 4896, 4898 are composed of a shape memory metal and are deformable from a first compressed configuration for delivery through a lumen of an endoscope and a second expanded configuration for treatment. In an embodiment, the tray includes a plurality of holes 4899 to allow air to escape at the beginning of an ablation procedure and to allow vapor to escape once the pressure and/or temperature within the enclosed treatment volume created between the two positioning elements 4896, 4898 reaches a predetermined limit, as described above. In some embodiments, conduit 4891 includes a filter 4893 having micro-holes that provide back pressure to the vapor being delivered, thereby pressurizing the vapor. The predetermined size of the pores in the filter determines the back pressure and thus the temperature of the vapor being produced.

It should be appreciated that the filter 4893 may be any structure that allows vapor to flow out of the port and restricts vapor flow back into the conduit or upstream within the conduit. Preferably, the filter is a thin porous metal or plastic structure located in the catheter lumen and adjacent to one or more ports. Alternatively, a one-way valve may be used that allows steam to flow out of the port but not back into the conduit. In one embodiment, this structure 4893, which may be a filter, valve or porous structure, is positioned within 5cm of the port, preferably within 0.1cm to 5cm from the port, and more preferably within less than 1cm from the port, which is defined as the actual opening through which vapor may flow out of the catheter and into the patient.

Fig. 49 illustrates an ablation system 4901 suitable for ablating prostate tissue according to some embodiments of the present description. The ablation system 4901 includes a catheter 4902 having an internal heating chamber 4903, the internal heating chamber 4903 disposed within a lumen of the catheter 4902 and configured to heat a fluid provided to the catheter 4902 to change the fluid to steam for ablation therapy. In one embodiment, the fluid is conductive brine and is converted to non-conductive or poorly conductive vapor. In one embodiment, the electrical conductivity of the fluid (e.g., saline) is reduced by at least 25%, preferably by 50%, more preferably by 90%, as determined by comparing the electrical conductivity of the fluid (e.g., vapor) prior to passage through the heating chamber with the electrical conductivity of the ablative agent (e.g., vapor) after passage through the heating chamber. It should also be understood that for each of the embodiments disclosed in this specification, the term ablative agent preferably refers only to heated steam or vapor and the inherent thermal energy stored therein, without any enhancement from any other energy source (including radio frequency, electrical, ultrasound, optical or other energy modalities).

In some embodiments, the catheter 4902 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. A plurality of openings 4904 are located near the distal end of the catheter 4902 for enabling a plurality of associated thermally conductive elements (e.g., needles 4905) to extend (from the catheter 4902 at an angle, wherein the angle ranges between 30 and 90 degrees) and to be deployed or retracted through the plurality of openings 4904. According to one aspect, the plurality of retractable needles 4905 are hollow and include at least one injection port 4906 to allow for delivery of an ablative agent, such as steam or vapor, through the needles 4905 as the needles 4905 are extended and deployed through the plurality of openings 4904 in the elongate body of the catheter 4902. In some embodiments, the infusion port is positioned along the length of the needle 4905. In some embodiments, the infusion port 4906 is positioned at the distal tip of the needle 4905. During use, such as water, air or CO ₂ Is circulated through optional port 4907 to cool conduit 4902. Steam for ablation and a cooling fluid for cooling are supplied to the catheter 4902 at the proximal end of the catheter 4902. A fluid such as saline is stored in a reservoir (such as saline pump 4914) connected to conduit 4902. The delivery of the ablative agent is controlled by the controller 4915 and the treatment is controlled by the treating physician via the controller 4915. The controller 4915 includes at least one processor 4923 in data communication with the brine pump 4914 and a conduit connection port 4921 in fluid communication with the brine pump 4914 . In some embodiments, at least one optional sensor 4922 monitors changes in the ablation region to direct the flow of the ablative agent. In some embodiments, the optional sensor comprises at least one of a temperature sensor or a pressure sensor. In some embodiments, conduit 4902 includes a filter 4916 having micro-pores that provides back pressure to the vapor being delivered, thereby pressurizing the vapor. The predetermined size of the pores in the filter determines the back pressure and thus the temperature of the vapor being produced. In some embodiments, the system further includes a foot pedal 4925 in data communication with the controller 4915, the switch 4927 on the conduit 4902, or the switch 4929 on the controller 4915 for controlling the flow of steam. In some embodiments, the needle has a mechanism attached to change its direction from being relatively parallel to the catheter to an angle of between 30 ° -90 ° with the catheter. In one embodiment, the mechanism is a pull wire. In some embodiments, the opening in the catheter is shaped to change the direction of the needle from being relatively parallel to the catheter to an angle of between 30 ° -90 ° with the catheter.

In one embodiment, a user interface included in microprocessor 4915 allows the physician to define the device, organ, and condition, which in turn creates default settings for temperature, circulation, volume (sound), and standard RF settings. In one embodiment, these default values may be further modified by the physician. The user interface also includes a standard display of all key variables, as well as warnings if the value exceeds or falls below a certain level.

Fig. 50 illustrates another view of the catheter 5002 of fig. 49 in accordance with some embodiments of the present description. Catheter 5002 includes an elongated body 5008 having a proximal end and a distal end. A plurality of openings 5004 are located near the distal end of the catheter 5002 for enabling a plurality of associated thermally conductive elements (e.g., needles 5005) to extend (from the catheter 5002 at an angle, wherein the angle ranges between 10 and 90 degrees) and be deployed or retracted through the plurality of openings 5004. According to one aspect, a plurality ofThe retractable needle 5005 is hollow and includes at least one injection port 5006 to allow for delivery of an ablative agent, such as steam or vapor, through the needle 5005 as the needle 5005 is extended and deployed through a plurality of openings 5004 in the elongate body of the catheter 5002. In some embodiments, the infusion port is positioned along the length of the needle 5005. In some embodiments, the infusion port 5006 is positioned at the distal tip of the needle 5005. Optionally during use, such as water, air or CO ₂ Through optional port 5007 to cool conduit 5002. The body 5008 includes at least one heating compartment 5003, the heating compartment 5003 being proximate to the optional port 5007 or the opening 5004 and just proximate to the optional port 5007 or the opening 5004. In an embodiment, the heating compartment 5003 includes at least two microwave antennas or microwave antenna arrays 5009 configured to receive RF current, heat, and convert a supplied fluid (e.g., saline) to steam or vapor for ablation.

Referring to fig. 50, to provide current to a conduit 5002, fluid for ablation, and optionally cooling fluid, an RF generator 5084, a first fluid pump 5074, and a second fluid pump 5085 are coupled to the proximal end of the body 5008. The first fluid pump 5074 pumps a first fluid (e.g., saline) through a first lumen (extending along the length of the body 5008) to the heating compartment 5003. The RF generator 5084 supplies electrical current to the microwave antenna array 5009 causing the microwave antenna array 5009 to generate heat, thereby converting fluid flowing through the heating chamber 5003 into steam. The generated vapor flows through the first lumen, opening 5004, needle 5005, and exits infusion port 5006 to ablate prostate tissue. Optionally, in some embodiments, a second fluid pump 5085 pumps a second fluid (e.g., water) through a second lumen (extending along the length of the body 5008) to an optional port 5007, wherein the second fluid exits the catheter 5002 to circulate in and cool the ablation zone. The flexible heating chamber 5003 imparts improved flexibility and operability to the catheter 5002, allowing a physician to better position the catheter 5002 when performing an ablation procedure, such as ablating prostate tissue of a patient.

Fig. 51 illustrates a system 5100 for prostate tissue ablation according to another embodiment of the present disclosure. The system 5100 includes a catheter 5101, and in some embodiments, the catheter 5101 includes a handle 5190 having actuators 5191, 5192 for extending at least one needle 5105 or more from a distal end of the catheter 5101 and expanding a positioning element 5111 at the distal end of the catheter 5101. In some embodiments, the actuators 5191 and 5192 can be one of a knob or slider or any other type of switch or button to enable the at least one needle 5105 or multiple needles to extend. The delivery of steam via conduit 5101 is controlled by controller 5115. In an embodiment, the catheter 5101 includes an outer sheath 5109 and an inner catheter 5107. The needle 5105 extends from the inner catheter 5107 at the distal end of the sheath 5109 or, in some embodiments, through an opening near the distal end of the sheath 5109. In an embodiment, the positioning element 5111 is expandable, positioned at the distal end of the inner catheter 5107, and can be compressed within the outer sheath 5109 for delivery. In some embodiments, the actuator 5191 includes a knob that is rotated a first degree, e.g., a quarter turn, to retract the outer sheath 5109. When the outer sheath 5109 is retracted, the locating element 5111 is exposed. In an embodiment, the positioning element 5111 comprises a disc or cone configured as a bladder anchor. In an embodiment, the actuator/knob is rotated a second extension, e.g., a second quarter turn, to further retract the outer sheath 5109 to deploy the needle 5105. In some embodiments, the number of deployed needles is two or more. In some embodiments, referring to fig. 51, 4C and 4E simultaneously, one or more needles 5105, 3116a are deployed from the lumen of inner catheter 5107, 3111a through slots or openings 3115a in outer sheath 5109, 3110a, which helps control needle path and isolate urethra from vapors. In some embodiments, the opening is covered with a slit cover 3119. In another embodiment, for example, as shown in fig. 4D, sleeve 3116b naturally folds outwardly when outer sheath 3110b is pulled back.

Referring again to fig. 51, in some embodiments, the catheter 5101 includes a port 5103 for delivering a fluid (e.g., cooling fluid) during ablation. In some embodiments, port 5103 is further configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, port 5103 is located atOn the handle 5190. In some embodiments, at least one microwave antenna 5113 is positioned at the distal end of the catheter 5101 proximal of the needle 5105. The microwave antenna 5113 is configured to receive an electrical current supplied by a connection line 5111 extending from the controller 5115 to the conduit 5101 to heat and convert a fluid, such as saline supplied via a conduit 5112 extending from the controller 5115 to the conduit 5101. The heated fluid or saline is converted to steam or vapor for delivery by the needle 5105 for ablation.

Fig. 52 illustrates a system 5200 for prostate tissue ablation according to another embodiment of the present description. The system 5200 includes a catheter 5201, and in some embodiments, the catheter 5201 includes a handle 5290 having actuators 5291, 5292 for extending at least one needle 5205 or multiple needles from the distal end of the catheter 5201. A drive mechanism disposed within the handle 5290 deploys and retracts the needle 5205 back toward the distal end of the catheter shaft 5201. In some embodiments, the actuators 5291 and 5292 may be one of a knob or slider or any other type of switch or button to enable at least one needle 5205 or multiple needles to extend. In some embodiments, the actuator 5291 is a button or switch that allows the physician to initiate treatment from the handle 5290 and foot pedal (not shown) using the system 5200. In some embodiments, a strain relief mechanism 5210 is configured at the distal end of the handle 5290, which connects the handle 5290 to the catheter 5201. The strain relief mechanism 5210 provides support for the catheter shaft 5201. The delivery of steam via conduit 5201 is controlled by controller 5215. A cable subassembly 5223 including a cable in the handle 5290 connects the catheter 5201 to the controller 5215. In an embodiment, the catheter 5201 includes an outer sheath 5209 and an inner catheter (not shown).

In various embodiments, the controller 5215r of the system of the present description (and the controllers 4515, 5115, 5515p of fig. 45, 51, and 55, respectively) comprises a computing device having one or more processors or central processing units, one or more computer-readable storage media (such as RAM, hard disk, or any other optical or magnetic medium), a controller (such as an input/output controller), at least one communication interface, and a system memory. The system memory includes at least one Random Access Memory (RAM) and at least one Read Only Memory (ROM). In an embodiment, the memory includes a database for storing raw data, images, and data related to the images. The plurality of functional and operational elements communicate with a Central Processing Unit (CPU) to effect operation of the computing device. In various embodiments, the computing device may be a conventional stand-alone computer, or alternatively, the functionality of the computing device may be distributed across networks of multiple computer systems and architectures and/or cloud computing systems. In some embodiments, execution of a plurality of program instructions or code sequences stored in one or more non-volatile memories enables or causes a CPU of a computing device to perform the various functions and processes as described herein. In alternative embodiments, hard-wired circuitry may be used in place of or in combination with software instructions to implement the processes of the systems and methods described herein. Thus, the described systems and methods are not limited to any specific combination of hardware and software.

The needle tip assembly 5225 is positioned within a needle chamber 5208 within the outer sheath 5209. The needle chamber 5208 can be a metal or plastic sleeve configured to receive the needle 5205 during delivery to assist in needle deployment and retraction. The needle tip assembly 5225, including the needle 5205, extends from the inner catheter at the distal end of the sheath 5209, or in some embodiments through an opening near the distal end of the sheath 5209, when pushed out of its lumen 5208. In an embodiment, the positioning element is also provided at the distal end of the inner catheter. The positioning element may be expandable and may be compressed within the outer sheath 5209 for delivery. In some embodiments, the actuator 5292 includes a knob that is rotated a first degree, e.g., a quarter turn, to retract the outer sheath 5209. When the outer sheath 5209 is retracted, the positioning element is revealed. In an embodiment, the actuator/knob 5292 is rotated a second extension, such as a second quarter turn, to further retract the outer sheath 5209 to deploy the needle 5205. In some embodiments, the number of deployed needles is two or more.

Fig. 52 shows a perspective view of a needle tip assembly 5225 that includes a needle 5205 attached to a needle attachment component 5207, in some embodiments, the needle attachment component 5207 includes a metal threaded fitting. A needle attachment component or threaded fitting 5207 connects the needle 5205 to the catheter 5201. In an embodiment, the needle attachment component 5207 includes a threaded surface fixedly attached to the end of the catheter 5201 and configured to have a needle 5205 threaded thereto. In some embodiments, needle 5205 is a 22 to 25G needle. In some embodiments, the needle 5205 has a coating gradient for insulation or echogenicity. The insulating coating 5206 can be ceramic, polymer, or any other material suitable for coating the needle 5205 and providing insulation and/or echogenicity to the needle 5205. A coating is provided at the base of the needle 5205 to alter the length of the needle tip.

Referring again to fig. 52, in some embodiments, the catheter 5201 includes tubing and connector subassemblies (ports) 5203 for delivering fluid (e.g., cooling fluid) during ablation. In some embodiments, port 5203 is further configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, the port 5203 is positioned on the handle 5290. In some embodiments, one or more microwave antennas 5213 are positioned at the distal end of the catheter 5201 near the one or more needles 5205. The one or more microwave antennas 5213 are configured to receive current supplied by a connection line 5211 extending from the controller 5215 to the conduit 5201 to heat and convert fluid, such as brine, supplied via a conduit 5212 extending from the controller 5215 to the conduit 5201. The heated fluid or saline is converted to steam or vapor for delivery by needle 5205 for ablation.

Fig. 53 illustrates an ablation system 5310 adapted for ablating endometrial tissue in accordance with an embodiment of the present disclosure. The ablation system 5310 includes a catheter 5311 having a catheter body 5315, the catheter body 5315 including an outer catheter 5316, an inner catheter 5317 positioned concentrically inside the distal end of the outer catheter 5316 and extendable outwardly from the distal end of the outer catheter 5316. The inner catheter 5317 includes at least one first distal attachment or positioning element 5312 and a second proximal attachment or positioning element 5313. During positioning of the catheter 5311 within the cervix or uterus of a patient, the inner catheter 5317 is positioned within the outer catheter 5316. During positioning of the conduit 5311, the first and second positioning elements 5312, 5313 in the first compressed configuration are constrained by the outer conduit 5316 and positioned within the outer conduit 5316. Once the distal end of outer catheter 5311 has been positioned within the cervix of the patient, inner catheter 5317 extends distally from the distal end of outer catheter 5316 and into the uterus of the patient. The first and second positioning elements 5312, 5313 expand and deploy in the uterus. In an embodiment, the first and second positioning elements 5312, 5313 include shape memory properties allowing them to expand once deployed. In some embodiments, the first and second positioning elements 5312, 5313 are composed of nitinol. In some embodiments, the first distal positioning element 5312 is configured to contact the uterine wall once deployed, position the inner catheter 5317 within the uterus, and the second proximal positioning element 5313 is configured to abut a distal portion of the cervix within the uterus once deployed, thereby preventing ablation vapors from returning into the cervical os. The internal heating compartment 5303 is disposed within the lumen of the inner catheter 5317 and is configured to heat fluid provided to the catheter 5311 to change the fluid to steam for ablation therapy. In some embodiments, the internal heating compartment is positioned just distal to the second positioning element 5313. In some embodiments, the catheter 5311 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. The inner catheter 5317 includes one or more infusion ports 5314 for infusing an ablative agent (e.g., vapor). In some embodiments, one or more infusion ports 5314 are positioned on the catheter 5311 between the first positioning element 5312 and the second positioning element 5313. In various embodiments, the first distal attachment or positioning element 5312 and the second positioning element 5313 comprise discs. A fluid, such as saline, is stored in a reservoir (such as saline pump 5314) connected to conduit 5311. The delivery of the ablative agent is controlled by controller 5315 and the treatment is controlled by the treating physician via controller 5315. The controller 5315 includes at least one processor 5323 in data communication with the brine pump 5314 and a conduit connection port 5321 in fluid communication with the brine pump 5314. In some embodiments, at least one optional sensor 5322 monitors changes in the ablation region to direct the flow of the ablative agent. In some embodiments, the optional sensor comprises at least one of a temperature sensor or a pressure sensor. In some embodiments, the conduit 5311 includes a filter 5316 having micropores that provides a back pressure to the delivered vapor, thereby pressurizing the vapor. The predetermined size of the pores in the filter determines the back pressure and thus the temperature of the vapor being produced. In some embodiments, the system further comprises a foot pedal 5325 in data communication with the controller 5315, the switch 5327 on the conduit 5311, or the switch 5329 on the controller 5315 for controlling the flow of steam.

In one embodiment, a user interface included in microprocessor 5315 allows the physician to define the device, organ, and condition, which in turn creates default settings for temperature, circulation, volume (sound), and standard RF settings. In one embodiment, these default values may be further modified by the physician. The user interface also includes a standard display of all key variables, as well as warnings if the value exceeds or falls below a certain level.

In another embodiment, outer catheter 5316 abuts the cervical canal mucosa without occluding the cervix and exudates from the uterine cavity. The space between the outer and inner conduits 5316, 5317 allows ventilation via the channel to allow heated air, steam or fluid to escape the uterine cavity without contacting and damaging the cervical canal.

Fig. 54 illustrates another view of the catheter 5311 of fig. 53 (referred to herein as catheter 5411) in accordance with some embodiments of the present description. The catheter 5411 includes an elongate body 5415 having a proximal end and a distal end. At the distal end, the catheter body 5415 includes an outer catheter 5416, the outer catheter 5416 having an inner catheter 5417, the inner catheter 5417 being concentrically positioned inside the distal end of the outer catheter 5416 and extendable outwardly from the distal end of the outer catheter 5416. The inner catheter 5417 includes a distal positioning element 5412 near its distal end and a proximal positioning element 5413 proximal to the distal positioning element 5412. In various embodiments, the positioning element is a disk. The outer catheter 5416 is configured to receive the inner catheter 5417 and constrain the positioning elements 5412, 5413 prior to positioning, as described above. A plurality of infusion ports 5414 are located on the inner catheter 5417 between the two positioning elements 5412, 5413. The inner catheter 5417 further includes at least one heating compartment 5403 just distal to the proximal disk 5413. In some embodiments, the heating compartment 5403 includes two or more microwave antennas 5409 configured to receive RF current, heat, and convert a supplied fluid (e.g., saline) into steam or vapor for ablation.

Referring to fig. 54, to provide current and liquid to the conduit 5411, a fluid pump 5474 and an RF generator 5484 are coupled to the proximal end of the body 5415. The fluid pump 5474 pumps fluid, such as saline, through a first lumen (extending along the length of the body 5415) to the heating compartment 5403. The RF generator 5484 supplies current to the microwave antenna 5409, causing the microwave antenna 5409 to generate heat, thereby converting fluid flowing through the heating chamber 5403 into steam. The generated steam flows through the first lumen and out of the port 5414 to ablate endometrial tissue. The flexible heating chamber 5403 imparts improved flexibility and operability to the catheter 5411, allowing a physician to better position the catheter 5411 when performing an ablation procedure (e.g., ablating endometrial tissue of a patient).

In various embodiments, the heating microwave antenna 5409 extends beyond the distal end of the proximal positioning element 5413 near the proximal positioning element 5413, or completely away from the distal end of the proximal positioning element 5413 but does not extend substantially beyond the proximal end of the distal positioning element 5412.

Fig. 55 illustrates a system 5500 for endometrial tissue ablation in accordance with another embodiment of the present disclosure. The ablation system 5500 includes a catheter 5501, in some embodiments, the catheter 5501 includes a handle 5590 having actuators 5591, 5592, 5593 for pushing forward the distal spherical tip 5589 of the catheter 5501 and for deploying the first distal positioning element 5511 and the second proximal positioning element 5512 at the distal end of the catheter 550. In an embodiment, catheter 5501 includes an outer sheath 5509 and an inner catheter 5507. In an embodiment, catheter 5501 includes a cervical collar 5515, cervical collar 5515 being configured to abut an external orifice once catheter 5501 has been inserted into the uterus of a patient. In an embodiment, a distal first positioning element 5511 and a proximal second positioning element The member 5512 is expandable, positioned at the distal end of the inner catheter 5507, and can be compressed within the outer sheath 5509 for delivery. In some embodiments, actuators 5592 and 5593 comprise knobs. In some embodiments, the actuator/knob 5592 is used to deploy the distal first positioning element 5511. For example, in an embodiment, the actuator/knob 5592 is rotated a quarter turn to deploy the distal first positioning element 5511. In some embodiments, the actuator/knob 5593 is used to deploy the proximal second positioning element 5512. For example, in an embodiment, the actuator/knob 5593 is rotated a quarter turn to deploy the proximal second positioning element 5512. In some embodiments, the handle 5590 includes only one actuator/knob 5592 that rotates a first quarter turn to deploy the first distal positioning element 5511, and then rotates a second quarter turn to deploy the second proximal positioning element 5512. In other embodiments, other combinations of actuators/knobs are used to deploy one or both of the first distal positioning element 5511 and the second proximal positioning element 5512. In some embodiments, catheter 5501 includes a port 5503 for delivering a fluid (e.g., cooling fluid) during ablation. In some embodiments, port 5503 is also configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, the port 5503 is positioned on the handle 5590. In some embodiments, at least one microwave antenna 5513 is positioned at the distal end of the proximal second positioning element 5512 of the catheter 5501. The microwave antenna 5513 is configured to receive current supplied by a connection line 5511 extending from the controller 5515 to the conduit 5501 to heat and convert a fluid, such as saline supplied via a conduit 5512 extending from the controller 5515 to the conduit 5501. The heated fluid or saline is converted to steam or vapor for delivery by ablation through port 5514. In some embodiments, catheter 5501 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. A plurality of small delivery ports 5514 are positioned on the inner catheter 5507 between the distal first positioning element 5511 and the second proximal positioning element 5512. Port 5514 is used for injection of an ablative agent, such as steam. Delivery of the ablative agent is controlled by controller 5515, and treatment is controlled by the treating physician via controller 5515。

Fig. 56 illustrates a system 5600 for ablating bladder tissue according to an embodiment of the present disclosure. The system 5600 includes a catheter 5630, and in some embodiments, the catheter 5630 includes a handle 5632 having actuators 5634, 5636, the actuators 5634, 5636 for pushing the distal end 5638 of the catheter 5630 forward and for deploying the distal positioning element 5640 at the distal end of the catheter 5630. In an embodiment, the catheter 5630 includes an outer sheath 5642 and an inner catheter 5644. In an embodiment, the distal positioning element 5640 is expandable, positioned at the distal end of the inner catheter 5644, and may be compressed within the outer sheath 5642 for delivery. In some embodiments, actuators 5634 and 5636 comprise knobs. In some embodiments, actuator/knob 5636 is used to deploy distal positioning element 5640. For example, in an embodiment, actuator/knob 5636 is rotated a quarter turn to deploy distally located element 5640. In some embodiments, other combinations of actuators/knobs are used to position element 5640. In some embodiments, the catheter 5630 includes a port 5646 for delivering a fluid (e.g., a cooling fluid) during ablation. In some embodiments, port 5646 is further configured to provide fluid collection, provide vacuum, and provide CO ₂ For integrity testing. In some embodiments, port 5646 is positioned on handle 5632. In some embodiments, at least one microwave antenna 5648 is positioned at the distal end of the catheter 5630. The microwave antenna 5648 is configured to receive an electrical current supplied by a connection 5650 extending from the controller 5652 to the conduit 5630 to heat and convert a fluid, such as saline supplied via a conduit 5654 extending from the controller 5652 to the conduit 5630. The heated fluid or saline is converted to steam or vapor for delivery through the port for ablation. In some embodiments, catheter 5630 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. A plurality of small delivery ports are located on the inner catheter 5644 between the distal positioning element 5640 and the microwave antenna 5648. The port is for injecting an ablative agent, such as steam. The delivery of the ablative agent is controlled by controller 5652 and the treatment is controlled by the treating physician via controller 5652.

In embodiments, the microwave-based ablation systems described herein allow for smaller diameters and greater flexibility because microwave antennas are more flexible than electrodes. Steam efficiencies of greater than 80% can be achieved because microwave antennas are more efficient than electrodes. The steam efficiency achieved by the microwave-based ablation system is more than 10% higher than the steam efficiency achieved by the electrode-based ablation system. In addition, microwave-based ablation systems can ablate relatively large lesions within 10 seconds due to their efficient vapor generation.

The above examples merely illustrate many applications of the system of the present invention. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention may be embodied in many other specific forms without departing from the spirit or scope of the present invention. The present examples and embodiments, therefore, are to be considered as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.

Claims

1. A system for ablating endometrial tissue of a patient, comprising:

an ablation catheter, comprising:

an outer sheath having a first diameter and a length extending between a proximal end and a distal end, the outer sheath configured with at least one opening;

an inner conduit coaxial with the outer sheath, the inner conduit having a second diameter smaller than the first diameter and configured to receive a fluid;

a proximal positioning element configured to expand from a first compressed delivery configuration to a second expanded deployed configuration;

a distal positioning element configured to expand from a first compressed delivery configuration to a second expanded deployed configuration;

at least one port positioned on the inner catheter; and

At least one heating member positioned within the inner conduit, wherein the at least one heating member is configured to convert the fluid received by the inner conduit into steam exiting from the at least one port of the inner conduit;

a handle having a proximal end and a distal end, wherein the proximal end is in electrical and fluid communication with a controller, wherein the ablation catheter extends from the distal end of the handle; and

the controller has at least one processor, wherein, upon start-up, the controller is configured to:

controlling delivery of the fluid into the inner catheter; and

controlling the transfer of energy to the at least one heating member.

2. The system of claim 1, wherein in an expanded configuration, the proximal positioning element and the distal positioning element are configured in a funnel shape.

3. The system of claim 2, wherein the funnel-shaped proximal positioning element is configured to allow vapor to escape from the uterine cavity.

4. The system of claim 1, wherein in the expanded configuration, the distal end of the distal positioning element is configured to be positioned near or adjacent to a fundus of a uterus and the proximal end of the proximal positioning element is configured to be positioned near or adjacent to an endocervical opening.

5. The system of claim 1, wherein the proximal positioning element and the distal positioning element comprise a wire mesh made of a shape memory alloy.

6. The system of claim 1, wherein a distal end of the inner catheter is configured to advance into a uterine cavity until the distal end reaches a fundus and then withdraw a first distance, wherein the outer sheath is configured to cover the inner catheter until the distal end of the inner catheter and to cover the proximal positioning element in a compressed delivery configuration and to cover the distal positioning element in the compressed delivery configuration.

7. The system of claim 6, wherein the outer sheath is configured to be coaxially retracted over the inner catheter to deploy the distal positioning element into an expanded deployed configuration and to deploy the proximal positioning element into an expanded deployed configuration, wherein the inner catheter is further configured to be advanced again until the distal positioning element is positioned proximate to or in contact with the bottom of the uterus.

8. The system of claim 1, wherein the heating component comprises an electrode in fluid communication with a lumen of the inner catheter.

9. The system of claim 8, wherein the handle further comprises a wire or power cord extending from a proximal end of the handle through the handle and into a proximal portion of the ablation catheter, wherein the wire or power cord is configured to receive an electrical current to heat the electrode and convert fluid in the inner catheter into steam for ablation.

10. The system of claim 9, wherein the handle further comprises a fluid line extending from the proximal end of the handle through the handle and into the ablation catheter, wherein the fluid line is configured to deliver fluid into the lumen of the inner catheter.

11. The system of claim 10, wherein the handle further comprises a strain relief positioned at the proximal end of the handle to provide support for the infusion tube and power line.

12. The system of claim 1, wherein the handle comprises:

at least one first button configured to control steam generation;

At least one second button positioned within the first sliding track and configured to control deployment of the proximally positioned element; and

at least one third button positioned within the second slide track and configured to control deployment of the distal positioning element.

13. The system of claim 12, wherein the first and second slide rails each comprise a plurality of recesses configured to provide incremental positioning of the proximal and distal positioning elements, wherein the plurality of recesses are indicative of a degree of deployment of the proximal and distal positioning elements.

14. The system of claim 12, wherein the at least one first button is configured to be locked when not operated.

15. The system of claim 12, wherein the position of the at least one second button located within the first sliding track and the at least one third button located within the second sliding track is indicative of a relative distance between the proximal positioning element and the distal positioning element.

16. The system of claim 12, wherein a graphic or text symbol is printed or embossed at the ends of the first and second sliding tracks to indicate whether the tracks correspond to the proximal or distal positioning elements.

17. The system of claim 1, wherein the inner conduit further comprises a plurality of rows, wherein each of the plurality of rows comprises a plurality of ports for delivering steam.

18. The system of claim 17, wherein each of the plurality of ports of one of the plurality of rows has a different size than each of the plurality of ports of each other of the plurality of rows to create a steam gradient along the ablation catheter.

19. The system of claim 1, wherein the ablation catheter further comprises a ball tip at the distal end to allow atraumatic insertion through a cervical canal of the patient.

20. The system of claim 1, wherein the ablation catheter further comprises a collar configured to be positioned at an external cervical os of the patient to stabilize the ablation catheter.