CN116528780A - Systems, devices, and methods for coring tissue - Google Patents

Systems, devices, and methods for coring tissue Download PDF

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Publication number
CN116528780A
CN116528780A CN202180032065.2A CN202180032065A CN116528780A CN 116528780 A CN116528780 A CN 116528780A CN 202180032065 A CN202180032065 A CN 202180032065A CN 116528780 A CN116528780 A CN 116528780A
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China
Prior art keywords
tissue
resecting
core
helical
target
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Pending
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CN202180032065.2A
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Chinese (zh)
Inventor
W·科恩
T·戴格劳
M·T·库恩
J·梅尔乔
T·米克
C·米尔斯
S·阮
J·萨拉查
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Prana Chest Co
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Prana Chest Co
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Publication of CN116528780A publication Critical patent/CN116528780A/en
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1482—Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00809—Lung operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B2017/32004—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes having a laterally movable cutting member at its most distal end which remains within the contours of said end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3488—Fixation to inner organ or inner body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00529—Liver
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00541—Lung or bronchi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A61B2018/1432—Needle curved
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3908—Soft tissue, e.g. breast tissue

Abstract

A method of resecting tissue may include positioning a tissue resecting device at a target tissue site, resecting a tissue core from the target tissue site with the tissue resecting device, removing the tissue core from the body, wherein removing the tissue core from the body creates a core cavity at the target tissue site.

Description

Systems, devices, and methods for coring tissue
Cross Reference to Related Applications
The present application is a continuation of the section of U.S. patent application Ser. Nos. 16/512,616, filed on even 16 th 7 month, 2019, and 16/512,628, filed on even 16 th 7 month, 2019, and claims priority and benefit from U.S. patent application Ser. No. 63/017,724, filed on even 30 th 4 month, 2020, which is hereby incorporated by reference in its entirety.
Background
Cancers are not single diseases, but rather a collection of related diseases, which can begin substantially anywhere in the body. In all types of cancer, it is common for cells of the body to begin dividing without stopping, proliferate and possibly spread into surrounding tissues. In the normal process, cells grow and divide to form new cells required for the body, and when they become damaged or older they die, the new cells replace the damaged or older cells; however, cancer can interrupt this process. For cancer, cells become abnormal, apoptotic cells do not die, and new cells are formed when not needed. These new cells may constantly proliferate or proliferate and may develop into a growth called a tumor.
Cancerous tumors are malignant, meaning that they can spread or invade surrounding healthy tissue. In addition, cancer cells can shed through the blood or lymphatic system and spread to remote areas in the body. Unlike malignant tumors, benign tumors do not spread or invade surrounding tissues; however, they may become large and cause damage. Both malignant and benign tumors can be resected or treated. Malignant tumors tend to regrow, while benign tumors can regrow, but are generally less likely to regrow.
Cancer is a genetic disease in that it is caused by changes in genes that control the way cells function, particularly in their growth and division. Genetic changes leading to cancer may be inherited, or they may occur throughout the lifetime of an individual, due to errors occurring in cell division or due to damage to DNA caused by certain environmental exposures (e.g., industrial/commercial chemicals and ultraviolet light). Genetic changes that may lead to cancer tend to affect three types of genes: namely, a protooncogene involved in normal cell growth and division, a tumor suppressor gene involved in controlling cell growth and division, and a DNA repair gene, which, as the name implies, are involved in repairing damaged DNA.
More than one hundred different types of cancer have been identified. The type of cancer may be named after the organ or tissue in which the cancer appears, such as lung cancer, or the cell type in which they are formed, such as squamous cell carcinoma. Unfortunately, cancer is the leading cause of death in the united states and worldwide. According to world health organization data, the number of new cancer cases will rise to twenty-five million per year for the next twenty years.
Lung cancer is one of the most common cancers today. According to the world health organization report of 2014, lung cancer occurs in 1400 tens of thousands, resulting in 880 tens of thousands of deaths worldwide, making it the most common cause of cancer-related deaths in men, and the second most common cause of cancer-related deaths in women. Lung cancer is a malignant lung tumor that, if not treated in time, may metastasize to adjacent tissues and organs. Most lung cancer is caused by long-term smoking; however, about 10% to 15% of lung cancer cases are tobacco independent. These non-tobacco cases are often caused by both genetic factors and exposure to certain environmental conditions, including radon, asbestos, second-hand tobacco smoke, other forms of air pollution, and other factors. The chance of lung cancer and other forms of cancer survival depends on early detection and treatment.
There is a real need for improved resected tissue.
Disclosure of Invention
The object of the present invention contemplates the removal of tissue cores from other target tissue sites, including but not limited to the lung, liver, pancreas or gastrointestinal tract (GI), for which management of post-coring bleeding may be desirable. The tissue core may have a prescribed (e.g., predefined) shape (e.g., columnar) and a size based on the coring device. Such coring devices may core tissue cores of the same or substantially the same shape in a repeatable manner. Such coring may be distinguished from other tissue removal, for example, using scissors or a scalpel, where the cut tissue will not have a predefined shape or size.
A method of coring tissue may include positioning a tissue ablation device at a target tissue site, causing the tissue ablation device to ablate a tissue core from the target tissue site, and removing the tissue core from the body, wherein removing the tissue core from the body creates a core cavity at the target tissue site. The tissue core includes at least a portion of a tissue lesion. Cutting the tissue core from the target tissue site may include mechanical transection. Resecting the tissue core from the target tissue site may comprise delivering radiofrequency energy. Resecting the tissue core from the target tissue site may comprise mechanical compression and delivery of radiofrequency energy. Resecting the tissue core from the target tissue site may comprise rotating the resection with the energized wire. Resecting the tissue core from the target tissue site may comprise one of mechanical compression, transmission of radio frequency energy, transmission of microwave energy, transmission of ultrasonic energy, or crossing of energized wires. Other ablation devices and procedures may be used. The ablation device may be configured for one or more of mechanical extrusion, transmission of radio frequency energy, transmission of microwave energy, transmission of ultrasonic energy, or transection with energized wires.
The method for coring tissue may further include inserting a cannula into a core cavity (core cavity) to support a wall of the core cavity. The method for coring tissue may further comprise delivering radio frequency energy to at least a portion of a wall defining the core cavity. The method for coring tissue may further comprise delivering chemotherapy to at least a portion of a wall defining the core cavity. The method for coring tissue may further comprise delivering microwave energy to at least a portion of a wall defining the core cavity. The method for coring tissue may further include transferring thermal energy to at least a portion of a wall defining the core cavity. The method for coring tissue may further include delivering ultrasonic energy to at least a portion of a wall defining the core cavity.
The method for coring tissue may further comprise sealing the biological fluid container. The sealed biological fluid container minimizes the flow of biological fluid into the cavity core. The sealing may be achieved using at least mechanical compression. The sealing may be achieved using at least radio frequency energy. The sealing may be achieved using at least microwave energy. The sealing may be achieved using at least ultrasonic energy. The sealing may be achieved using one or more of compression or transfer energy, such as radio frequency, microwave, ultrasonic, or thermal energy.
The present invention relates to a system, device and method for performing lung variable resection. Lung needle biopsies, such as X-rays or CAT scans, are typically performed when abnormalities are found in the imaging examination. In lung needle biopsies, a fine needle is used to take a lung tissue sample for examination under a microscope to determine if abnormal cells are present. For small-sized [ ]<6 mm) and intermediate (6-12 mm) nodules, tissue diagnosis is challenging. CT guided biopsies of peripheral lesions through the chest wall (80%) or through bronchoscopes (20%) produced only 0.001-002 cm 2 And thus, only successfully identified in 60% of the nodules when cancer is present. Although bronchoscopy techniques and technology continue to evolve, the accuracy, specificity, and sensitivity of biopsies will always be limited when dealing with small and medium-sized nodules around the lungs.
If it is determined that the lesion is cancerous, a second surgery may be performed to ablate the lesion, followed by chemotherapy and/or radiation therapy. The second procedure is likely to involve lung surgery. These procedures are typically accomplished through incisions between the ribs. Depending on the state of the cancer, there are many possible procedures. For certain types of lung cancer, video assisted thoracic surgery is a less invasive procedure. It is performed through a small incision using endoscopic methods, typically used to make wedge-shaped resections of smaller lesions near the lung surface. In wedge resection, a portion of the leaf is resected. In a sleeve resection, a portion of the large airway is resected, thereby preserving more lung function.
Nodules deeper than 2-3 cm from the lung surface, once determined to be suspicious, are difficult to locate and resect using laparoscopic or robotic lung retention techniques, despite preoperative image guided biopsies and localization. Thus, the surgeon performs an open chest or lobectomy to ablate lung nodules 2-3 cm from the lung surface. Open chest surgery is an open procedure in which a portion of the lobes, the whole lobes, or the entire lung is excised. In pneumonectomy, the entire lung is resected. This type of surgery is clearly the most aggressive. In a lobectomy, the entire lung section or lobe is excised and less invasive than the excision of the entire lung. All thoracoscopic lung procedures require a highly trained and experienced thoracic surgeon, and the quality of the surgical results remain consistent with the surgical experience.
Any of these types of lung surgery is a major surgery with possible complications, depending on the extent of the surgery and the overall health of the patient. In addition to the reduction in lung function associated with any of these procedures, recovery may take weeks to months. Open chest surgery requires rib diffusion, thereby increasing postoperative pain. Although video assisted thoracic surgery is less invasive, it still has a long recovery period. Furthermore, once the procedure is completed, the overall treatment may require systemic chemotherapy and/or radiation therapy.
As noted above, fine needle biopsies may not be entirely of diagnostic significance. A fine needle biopsy procedure involves guiding a needle under two-dimensional imaging into three-dimensional space. Thus, the physician may miss the lesion, or even if he or she hits the correct target, the lesion excised through the needle may not contain cancer cells or cells needed to assess tumor invasiveness. A needle biopsy can remove enough tissue to form a smear on a slide. The device of the present invention is designed to resect the entire lesion, or a substantial portion thereof, while minimizing the amount of healthy lung tissue resections. This provides a number of advantages. First, the entire lesion can be examined to obtain a more accurate diagnosis without confounding sampling errors, cell stacking losses or overall structure. Second, since the entire lesion is resected, a secondary operation as described above may not be required. Third, localized chemotherapy and/or energy-based tumor ablation, such as radiation therapy, may be introduced through the lumen created by the excision of the lesion.
In at least one embodiment, a method for resecting a tissue lesion is disclosed that defines: including anchoring to tissue lesions; forming a channel in the tissue leading to a lesion in the tissue; creating a tissue core including tissue lesions; connecting the tissue cores at a connection point downstream of the tissue lesion; severing the tissue core to form tissue between the junction and the tissue lesion; and removing the tissue core from the channel.
To be consistent with aspects of the present disclosure, a cannula may be inserted into the passageway either before or after removal of the tissue core. The cannula may also be anchored to the tissue. To be consistent with another aspect of the invention, topical treatment may be provided through a cannula.
In some embodiments, creating the tissue core includes cauterizing and cutting the tissue. The connective tissue may include cauterized tissue referred to as a junction at a particular location. The severing of the tissue core may be performed with a snare, an energized wire, or any other device capable of severing tissue.
In some embodiments, the tissue core is formed by first sealing the blood vessel and then severing the tissue to form the core.
Drawings
The following figures generally illustrate various examples discussed in the present disclosure by way of example, and not by way of limitation. In the drawings:
fig. 1 depicts a tissue ablation device in accordance with an embodiment of the present invention.
Fig. 2 shows a cross-sectional view of the tissue ablation device of fig. 1.
Fig. 3 shows a cross-sectional view of a tissue ablation device in accordance with an embodiment of the present invention.
Fig. 4 depicts a cross-sectional view of a tissue ablation device in accordance with an embodiment of the present invention.
Fig. 5 illustrates an exemplary anchor bolt that can be employed in a lesion removal method according to an embodiment of the present invention.
Fig. 6 shows a series of incision blades for a lesion removal method according to an embodiment of the present invention.
Fig. 7 shows a tissue expander suitable for use in a lesion removal method according to an embodiment of the present invention.
FIG. 8 illustrates a flow chart of an example method for coring and for sealing tissue.
Detailed Description
The present invention relates to systems and methods for coring tissue. Various tissues and sites may benefit from the disclosed systems and methods.
The tissue core may have a prescribed (e.g., predefined) shape (e.g., columnar) and a size based on the coring device. Such coring devices may core tissue cores of the same or substantially the same shape in a repeatable manner. Such coring may be distinguished from other tissue removal, for example, using scissors or a scalpel, where the cut tissue will not have a predefined shape or size.
The present invention relates to methods and systems for coring tissue.
A method for coring tissue may include positioning a tissue ablation device at a target tissue site, causing the tissue ablation device to ablate a tissue core from the target tissue site, and withdrawing the tissue core from the body, wherein withdrawing the tissue core from the body creates a core cavity at the target tissue site. The tissue core includes at least a portion of a tissue lesion. Cutting the tissue core from the target tissue site may include mechanical transection. Resecting the tissue core from the target tissue site may comprise delivering radiofrequency energy. Resecting the tissue core from the target tissue site may comprise mechanical compression and delivery of radiofrequency energy. Resecting the tissue core from the target tissue site may comprise rotating the resection with the energized wire.
Resecting the tissue core from the target tissue site may comprise one of mechanical compression, transmission of radio frequency energy, transmission of microwave energy, transmission of ultrasonic energy, or crossing of energized wires. Other ablation devices and procedures may be used. The ablation device may be configured for one or more of mechanical extrusion, transmission of radio frequency energy, transmission of microwave energy, transmission of ultrasonic energy, or transection with energized wires.
The present invention relates to methods and systems for coring tissue and sealing a core cavity formed by resecting a tissue core. Such a method may include disposing a filler material in the core cavity. The method may include applying pressure to a portion of the core cavity, such as to a wall defining the core cavity. The method may include ablating a portion of the core cavity, such as a wall defining the core cavity. The method may include sealing the tissue cavity with a device that causes sealing of the cavity, such as a suture, a suturing device, an ultrasonic tissue sealing device, a bipolar radio frequency sealing device, or any combination thereof. The method may include providing a luminal sealing material, such as a tissue graft, hemostatic patch, hemostatic agent, such as fibrin or thrombin, and bioadhesive material, such asOr any combination thereof to enclose a tissue cavity.
The method may include simultaneously coring and sealing the vessel as an implementation of the coring procedure. For example, radio frequency energy may be provided between the coil and the anvil electrode. As a further example, the coil may be rotated to a target site, the anvil electrode may cause closure of the coil, radio frequency energy may be used to seal an area near the target site, and a cutting blade may be used to core tissue. Such a sequence may be repeated until the coring tissue is within the resected tube. At this point, a connection (e.g., using another set of electrodes) may be made to seal any potential blood vessels connecting the core tissue with surrounding tissue. In one aspect, a mechanical linkage may be deployed to complete the coring process so that coring tissue may be removed, ready the coring cavity for any subsequent step.
The method may comprise any combination or permutation of: 1) placement of the anchoring device into the tissue cavity, 2) placement of the tissue channel port into the tissue cavity, 3) placement of the tissue sealing device into the tissue cavity (with or without the tissue channel port, with or without guidance from the anchoring device), 4) placement of the tissue sealing device to seal at least a portion of the tissue cavity, 5) introduction of a filler material into the tissue cavity (with or without a filler material delivery device, with or without prior placement of the tissue sealing device into the tissue cavity, with or without removal of the tissue sealing device after sealing at least a portion of the tissue cavity, with or without the tissue channel port), 6) placement of a cavity sealing material adjacent the tissue cavity (with or without a tissue sealing device within the tissue cavity, with or without removal of the tissue sealing device after sealing at least a portion of the tissue cavity, with or without introduction of the filler material into the tissue cavity), 7) placement of a cavity sealing device adjacent the tissue, and 8) closure of the tissue cavity (with or without any combination or permutation of the foregoing steps). As described herein, the methods can be used to core and/or seal tissue at various target sites. While the lung is used as an illustrative example, it should not be so limited, as other target sites may be pierced or actively cored, and may benefit from the disclosed sealing methods.
Various methods, devices, and systems can be used to core or resect tissue.
A method of resecting a tissue lesion may comprise introducing a tissue resecting device to a target tissue site, resecting a tissue core from the target tissue site by the tissue resecting device, and removing the tissue core from the body. The tissue core may comprise at least a portion of a tissue lesion. A method may also include creating a core cavity at a target tissue site. A method may also include inserting a cannula into the core cavity. A method may also include transmitting radio frequency energy through the core cavity. One method may further comprise delivering chemotherapy through the core cavity. A method may also include transmitting microwave radiation through the core cavity. A method may also include transferring thermal energy through the core cavity. A method may also include transmitting ultrasonic energy through the core cavity. The tissue ablation device may be configured to deliver radiofrequency energy. The tissue resecting device may be configured as a mechanical rotary cut. The tissue ablation device may include mechanical compression and delivery of radio frequency energy. A method may also include severing a tissue core from a target tissue site. As an example, the means for severing the tissue core may include mechanical rotary cutting. As a further example, the means for severing the tissue core may include delivery of radiofrequency energy. Means for severing the tissue core may include mechanical compression and transmission of radio frequency energy. The means for severing the tissue core may include a rotary cut with an energized wire. Other devices may be used.
A method of resecting a tissue core may comprise introducing a tissue resecting device to a target tissue site, resecting the tissue core from the target tissue site by the tissue resecting device, and removing the tissue core from the body. A method may also include creating a core cavity at a target tissue site. A method may also include inserting a cannula into the core cavity. A method may also include transmitting radio frequency energy through the core cavity. One method may further comprise delivering chemotherapy through the core cavity. A method may also include transmitting microwave radiation through the core cavity. A method may also include transferring thermal energy through the core cavity. A method may also include transmitting ultrasonic energy through the core cavity. The tissue ablation device may be configured to deliver radiofrequency energy. The tissue resecting device may be configured as a mechanical rotary cut. The tissue resecting device may be configured to mechanically compress and deliver radiofrequency energy. A method may also include severing a tissue core from a target tissue site. The means for severing the tissue core may include mechanical transection. The means for severing the tissue core may include delivering radio frequency energy. Means of severing the tissue core may include mechanical compression and delivery of radio frequency energy. The means for severing the tissue core may include a rotary cut with an energized wire.
A method of resecting a tissue core may comprise introducing a tissue resecting device to a target tissue site. The tissue resecting device may comprise one or more of: a first clamping element comprising a spiral coil and a first electrode, or a second clamping element comprising a second electrode. If included, the second clamping element may be positioned opposite at least a portion of the first clamping element. The method may further include causing the tissue ablation device to ablate the tissue core from the target tissue site and removing the tissue core from the body. A method may also include creating a core cavity at a target tissue site. A method may also include inserting a cannula into the core cavity. A method may also include transmitting radio frequency energy through the core cavity. One method may further comprise delivering chemotherapy through the core cavity. A method may also include transmitting microwave radiation through the core cavity. A method may also include transferring thermal energy through the core cavity. A method may also include transmitting ultrasonic energy through the core cavity. The tissue ablation device may be configured for ablating a tissue core including delivering radio frequency energy. The tissue resecting device may be configured to resect a tissue core including a mechanical transition. The tissue ablation device may be configured for ablating a tissue core, including mechanical compression and delivering radio frequency energy. A method may also include severing a tissue core from a target tissue site. The means for severing the tissue core may include mechanical transection. The means for severing the tissue core may include delivering radio frequency energy. Means of severing the tissue core may include mechanical compression and delivery of radio frequency energy. The means for severing the tissue core may include a rotary cut with an energized wire.
A method of sealing a biological fluid container may include piercing a target biological fluid container containing at least a portion of at least one target tissue site with a helical tissue sealing mechanism, wherein the helical tissue sealing mechanism includes a helical piercing element and a clamping element. Wherein the method may comprise causing the helical tissue sealing mechanism to apply mechanical compression to the at least one target biological fluid container and to transfer energy to seal the at least one target biological fluid container. The helical puncturing element may comprise a clamping element. Mechanical compression may be applied between the helical puncturing element and the clamping element. The method may further comprise a second clamping element. Mechanical compression may be applied between the first and second clamping elements. The delivered energy may comprise monopolar radiofrequency energy. The energy transferred may comprise bipolar radio frequency energy. The energy transferred may include thermal energy. The energy transferred includes ultrasonic energy.
A method of sealing biological fluid containers may include piercing a target tissue site with a helical piercing element, adjusting a pitch of the helical piercing element to apply mechanical compression to the target tissue, and delivering energy to seal at least one biological fluid container in the target tissue. The helical puncturing element may comprise a plurality of tissue sealing electrodes. The energy transferred may comprise monopolar radiofrequency energy. The energy transferred may comprise bipolar radio frequency energy. The energy transferred may include thermal energy. The energy transferred may include ultrasonic energy.
The tissue resecting device may comprise a first clamping element comprising a helical coil, a second clamping element, the second clamping element being positioned opposite at least a portion of the first clamping element, the first and second electrodes configured for delivering radio frequency energy for sealing tissue, and a resecting element configured for transecting at least a portion of the sealed tissue. The tissue resecting device may further comprise: a first actuator operable to actuate the first or second clamping element to apply mechanical compression to tissue, and a second actuator operable to actuate the cutting element to transect tissue. The helical coil may comprise first and second continuous coil segments. The first coil section may comprise a generally planar open loop. The first coil section may be helical and may have a zero pitch. The second coil segment may be helical and may have a non-zero pitch. The second coil segment may have a variable pitch. The first coil section may be helical and may have a first pitch, and the second coil section may be helical and may have a second pitch, and at least one of the first and second pitches may be variable. The first electrode may be comprised of at least a portion of the first clamping element. The second electrode may be comprised of at least a portion of the second clamping element. The helical coil may include a blunt tip. The first and second electrodes may comprise matching or substantially matching surface profiles. At least a portion of the cutting element may include a sharpened edge. The ablation element may include at least one electrode configured to deliver radiofrequency energy. The cutting element may comprise an ultrasonic blade. The tissue ablation device may further include a second ablation element configured to sever a tissue core from a target tissue site. At least a portion of the second cutting element may include a sharpened edge. The second ablation element may include at least one electrode configured to deliver radiofrequency energy. The second ablation element may include an energized wire. The second cutting element may comprise a suture. The tissue ablation device may further comprise an actuator operable to actuate the second ablation element to transect tissue.
The tissue resecting device may comprise: a first clamping member having a helical coil disposed at a distal end, a second clamping member positioned opposite at least a portion of the first clamping member, first and second electrodes for delivering radio frequency energy for sealing tissue, and a cutting member configured for transecting at least a portion of the sealed tissue. The tissue resecting device may further comprise: a first actuator operable to actuate the first or second clamping element to apply mechanical compression to the tissue, and a second actuator operable to actuate the cutting element to transect the tissue. The helical coil may include first and second continuous coil segments. The first coil section includes a generally planar open loop. The first coil section may be helical and may have a zero pitch. The second coil segment may be helical and may have a non-zero pitch. The second coil segment may have a variable pitch. The first coil section may be helical and may have a first pitch, and the second coil section may be helical and may have a second pitch, and at least one of the first and second pitches may be variable. The first electrode may be composed of at least a portion of a spiral coil. The first electrode may be comprised of at least a portion of the first clamping element. The second electrode may be comprised of at least a portion of the second clamping element. The helical coil may include a blunt tip. The first and second electrodes may comprise matching or substantially matching surface profiles. At least a portion of the cutting element may include a sharpened edge. The ablation element may include at least one electrode configured to deliver radiofrequency energy. The cutting element may comprise an ultrasonic blade. The tissue ablation device may further include a second ablation element configured to sever a tissue core from a target tissue site. At least a portion of the second cutting element may include a sharpened edge. The second ablation element may include at least one electrode configured to deliver radiofrequency energy. The second ablation element may include an energized wire. The second cutting element may comprise a suture. The tissue ablation device may further comprise an actuator operable to actuate the second ablation element to transect the tissue.
The tissue resecting device may comprise: a first clamping element comprising a helical coil and a first electrode, and a second clamping element comprising a second electrode, the second clamping element being positioned at least a portion opposite the first clamping element. The first and second clamping elements may be configured to: (a) For delivering radiofrequency energy for sealing tissue, and (b) for mechanical compression of tissue transection. The tissue resecting device may further comprise a first actuator operable to actuate the first or second clamping element to apply mechanical compression to the tissue and a second actuator operable to actuate the resecting element to transect the tissue. The helical coil may include first and second continuous coil segments. The first coil section may comprise a generally planar open loop. The first coil section may be helical and may have a zero pitch. The second coil segment may be helical and may have a non-zero pitch. The second coil segment may have a variable pitch. The first coil section may be helical and may have a first pitch, and the second coil section may be helical and may have a second pitch, and at least one of the first and second pitches may be variable. The first electrode may be composed of at least a portion of a spiral coil. The first electrode may be comprised of at least a portion of the first clamping element. The second electrode may be comprised of at least a portion of the second clamping element. The helical coil may include a blunt tip. The first and second electrodes may comprise matching or substantially matching surface profiles. At least a portion of the cutting element may include a sharpened edge. The ablation element may include at least one electrode configured to deliver radiofrequency energy. The cutting element may comprise an ultrasonic blade. The tissue ablation device may further include a second ablation element configured to sever a tissue core from a target tissue site. At least a portion of the second cutting element may include a sharpened edge. The second ablation element may include at least one electrode configured to deliver radiofrequency energy. The second ablation element may include an energized wire. The second cutting element may comprise a suture. The tissue ablation device may further comprise an actuator operable to actuate the second ablation element to transect tissue.
A surgical instrument system for resecting tissue may comprise: an end effector is operable to cut and seal tissue, wherein the end effector and generator are configured to power the end effector, having first and second electrodes for sealing tissue. The end effector may include: a first clamping element comprising a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes for delivering radio frequency energy for sealing tissue, and a cutting element for transecting at least a portion of the severed tissue. The surgical instrument system may further include a controller in communication with the generator, wherein the controller is configured to control the generator to provide radiofrequency energy sufficient to seal tissue to the first and second electrodes of the end effector based on the at least one sensed operating condition of the end effector. The controller may be configured to sense the presence of tissue at the end effector. The controller may be configured to sense the presence of tissue at the end effector based on the measured impedance levels associated with the first and second electrodes. The controller may be configured to sense a force applied to the at least one first or second clamping element to detect the presence of tissue at the end effector. The controller may be configured to sense a position of the cutting element relative to the at least one first or second clamping element. The controller may be configured to control the generator to provide radio frequency energy at the end effector when the end effector is actuated and no tissue on the end effector is sensed. The controller may be configured to control the generator to provide continuous radio frequency energy. The controller may be configured to control the generator to automatically provide an increase or decrease in the amount of radio frequency energy. The system may further include: a first actuator operable to actuate the first or second clamping element to apply mechanical compression to tissue; and a second actuator operable to actuate the cutting element to transect the tissue. The helical coil may include first and second continuous coil segments, the first coil segment including a first electrode. The first coil section may comprise a generally planar open loop. The first coil section may be helical and may have a zero pitch. The second coil segment may be helical and may have a non-zero pitch. The second coil segment may have a variable pitch. The first coil section may be helical and may have a first pitch, and the second coil section may be helical and may have a second pitch, and at least one of the first and second pitches may be variable. The first electrode may be composed of at least a portion of a spiral coil. The first electrode may be comprised of at least a portion of the first clamping element. The second electrode may be comprised of at least a portion of the second clamping element. The helical coil may include a blunt tip. The first and second electrodes may comprise matching or substantially matching surface profiles. At least a portion of the cutting element may include a sharpened edge. The ablation element may include at least one electrode configured to deliver radiofrequency energy. The cutting may include an ultrasonic blade. The tissue ablation device may further include a second ablation element configured to sever a tissue core from a target tissue site. At least a portion of the second cutting element may include a sharpened edge. The second ablation element may include at least one electrode configured to deliver radiofrequency energy. The second ablation element may include an energized wire. The second cutting element may comprise a suture. The tissue ablation device may further comprise an actuator operable to actuate the second ablation element to transect tissue.
The tissue resecting device may comprise: a first clamping element comprising a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes configured to deliver radio frequency energy for sealing tissue, a first cutting element configured to transect at least a portion of the sealed tissue, first and second connecting elements, and a second cutting element positioned between the first and second connecting elements. The tissue ablation device may further comprise a first actuator operable to actuate the first or second clamping element to apply mechanical compression to the tissue, and a second actuator operable to actuate the ablation element to transect the tissue. The helical coil may include first and second continuous coil segments. The first coil section may comprise a generally planar open loop. The first coil section may be helical and may have a zero pitch. The second coil segment may be helical and may have a non-zero pitch. The second coil segment may have a variable pitch. The first coil section may be helical and may have a first pitch, and the second coil section may be helical and may have a second pitch, and at least one of the first and second pitches may be variable. The first electrode may be composed of at least a portion of a spiral coil. The first electrode may be comprised of at least a portion of the first clamping element. The second electrode may be comprised of at least a portion of the second clamping element. The helical coil may include a blunt tip. The first and second electrodes may comprise matching or substantially matching surface profiles. At least a portion of the cutting element may include a sharpened edge. The ablation element may include at least one delivery for radiofrequency energy. The cutting element may comprise an ultrasonic blade. The tissue ablation device may further include a second ablation element configured to sever a tissue core from a target tissue site. At least a portion of the second cutting element may include a sharpened edge. The second ablation element may include at least one electrode configured to deliver radiofrequency energy. The second ablation element may include an energized wire. The second cutting element may comprise a suture. The tissue ablation device may further comprise an actuator operable to actuate the second ablation element to transect tissue.
The tissue sealing mechanism may include a helical coil having a generally diagonal cross-section and a tapered point disposed at the distal end, first and second helical tissue sealing surfaces, wherein the first and second helical tissue sealing surfaces are provided by parallel planes of the helical coil, a first electrode disposed on the first helical tissue sealing surface, and a second electrode disposed on the second helical tissue sealing surface, wherein the first and second electrodes are configured to apply bipolar radiofrequency energy for sealing tissue. The helical coil may include first and second continuous coil segments. The helical coil may include a blunt tip. The first and second electrodes may have substantially matching surface profiles. The first and second helical tissue sealing surfaces may further comprise a plurality of electrodes for delivering bipolar radiofrequency energy.
FIGS. 1-7 illustrate example apparatus that can be used to effect a coring process, as described herein. For example, the ablation device of the invention may include an energy arrangement capable of penetrating tissue toward a target lesion. In one embodiment shown in fig. 1, a tissue ablation device 1100 includes an outer tube 1105 provided with a distal edge profile and having an inner diameter idoter. The coil 1110 is connected to the outer tube 1105 with the number of coil turns spaced from and opposite the distal end of the outer tube 1105. The coil 1110 preferably has a slightly blunted tip 1115 to minimize its likelihood of penetrating the blood vessel, while being sufficiently sharp to penetrate tissue such as the pleura and parenchyma. In some embodiments, the coil 1110 may take the form of a helix having a constant or variable pitch. The coil 1110 may also have a variable cross-sectional geometry. Electrode 1130 is disposed on or embedded in the surface of coil 1110.
In some embodiments, as shown in fig. 1, coil 1110 may include a plurality of consecutive coil segments, e.g., coil segments 1120 and 1125. The coil segment 1120 includes a helical member having a zero pitch, e.g., a generally planar open loop structure, having an inner diameter ID coil and an outer diameter OD coil. The coil segments 1125 comprise a spiral structure of constant or variable pitch and constant or variable cross-sectional geometry. In this embodiment, the electrode 1130 may be disposed on the surface of the coil segment 1120 or embedded in the coil segment 1120.
The center tube 1200 is provided with a tip having a distal edge profile, comprising one or more surface segments, and having an OD center of an outer diameter and an ID center of an inner diameter. As shown in fig. 2, an electrode 1205 is disposed on or embedded in at least one surface segment. The center tube 1200 is skillfully disposed within the outer tube 1105 and positioned such that the electrode 1205 is opposite and overlapping at least a portion of the electrode 1130. The space between electrode 1205 and electrode 1130 is referred to as the tissue clamping area. To remain consistent with one aspect of the invention, OD center > ID coil and OD coil > ID center. In some embodiments, the OD center is approximately equal to the OD coil. Thus, the center tube 1200 can be advanced through the tissue clamping region toward the coil 1110 such that the electrode 1205 is immediately adjacent to the electrode 1130.
The resecting tube 1300 is slidably disposed within the center tube 1200. The distal end of the resecting tube 1300 is provided with a blade to facilitate tissue cutting.
To enable tissue ablation, the ablation device 1100 may be inserted into the tissue and the outer tube 1105 may be advanced a predetermined distance to access the target. The coil segments 1125 allow the device to penetrate tissue in a manner similar to a cork screw. As the coil segment 1125 penetrates the tissue, any blood vessel in its path is either moved planarly to the coil segment 1120 or pushed off the wire 1100 for a subsequent number of turns. The coil tip 1115 is sufficiently blunt to minimize its chance of penetrating the blood vessel, while still being sufficiently sharp to penetrate certain tissues, such as the lung pleura and parenchyma. Then, the center tube 1200 may be advanced a predetermined distance toward the target. Any container disposed in the tissue clamping area will be sandwiched between electrode 1130 and electrode 1205. The container may then be sealed by applying bipolar energy to electrode 1130 and electrode 1205. Once the vessel is sealed, the resecting tube 1300 is advanced to the depth of the tissue core to which the outer tube 1105 has been reached. The sealing and cutting process may be repeated to create a core of the desired size.
To remain consistent with an aspect of the invention, the ablation device 1100 may also be configured to dissect a target lesion and seal tissue near the anatomical site. To facilitate dissection and sealing, as shown in fig. 3, the center tube 1200 is provided with a ligation snare 1230, first and second connection electrodes 1215 and 1220, and a cut-out snare 1225. As used herein, the word "snare" refers to a flexible wire, e.g., a string or a wire. The inner wall surface of the center tube 1200 includes upper and lower circumferential groove passages 1212 and 1214 provided at the distal end. The first and second connection electrodes 1215 and 1220 are disposed on the inner wall of the center tube 1200 such that the lower peripheral groove 1214 is located therebetween. Upper trench passageway 1212 is disposed axially above connection electrodes 1215 and 1220.
The ligating snare 1230 is disposed in the lower circumferential groove 1214 and extends axially along the outer wall surface of the center tube 1200 to a snare activation mechanism (not shown). A cutting snare 1225 is disposed in the upper circumferential groove 1212 and extends axially along the outer wall surface of the center tube 1200 to a snare activation mechanism (not shown). The outer surface of the center tube 1200 may be provided with a plurality of axially extending grooved channels that receive the cutoff snare 1225, and the ligating snare 1230 communicates with the upper and lower circumferential grooved channels 1212 and 1214. In addition, the electrode leads for connecting electrodes 1215 and 1220 may extend to the energy source via axially extending grooved channels.
In operation, the ablation device 1100 of the present embodiment can separate and seal a tissue core. The resecting tube 1300 may be retracted to expose the ligating snare 1230, which is preferably made of a flexible wire, e.g., suture. The ligation snare 1230 may be engaged to grasp tissue and pull tissue to the inner wall surface between the first and second connection electrodes 1215 and 1220. Bipolar energy is then applied to first and second electrodes 1215 and 1220 to seal, i.e., cauterize, tissue. Once sealed, the resecting tube 1300 may be further retracted to expose the severing snare 1225, which may then be activated to sever the tissue core upstream from the point (connection point) at which the tissue was sealed. In some embodiments, the cutoff snare 1225 has a diameter that is smaller than the diameter of the ligature snare 1230. Smaller diameters facilitate tissue sectioning. Thus, the ablation device 1100 according to the present embodiment is capable of both creating a core of tissue and disengaging the core from surrounding tissue.
In an alternative embodiment, the ablation device 1100 of the present invention is provided with a single snare, disposed between the connection electrodes, which both connects and cuts tissue. In this embodiment, a single snare first pulls tissue to the inner wall surface of the base tube 1200, bipolar energy between the connection electrodes 1215 and 1220 is then applied between the first and second electrodes 1215 and 1220 to seal, i.e., cauterize, the tissue. Once sealed, the snare is pulled further to sever the tissue core.
In yet another embodiment, the cutting and sealing may be performed without the use of electrodes. In this embodiment, the ligature snare 1230 comprises a set of knots 1235 and 1240 which tighten under load, for example as shown in fig. 4, ligature is performed by retracting the resecting tube 1300 to expose the ligature snare 1230 and activate the ligature snare 1230, the cable tissue of which tightens as the ligature knot tightens. Once the tissue is lashed, the resecting tube 1300 may be further retracted to expose the cutting snare 1225, and may then be activated to sever the resected tissue core upstream from the point at which the tissue was lashed.
Methods and systems for resecting tissue lesions, such as lung lesions, using a resecting device are also contemplated by the present invention. The method generally includes anchoring the target lesion for removal, creating a passageway in the tissue to the target lesion, creating a tissue core including the anchored lesion, connecting the tissue core and sealing surrounding tissue, and removing the tissue core including the target lesion from the passageway.
Anchoring may be performed by any suitable structure for securing the device to the lung. Once the lesion is anchored, a passageway may be created to facilitate insertion of the ablation device 1100. The passageway may be created by making an incision in the lung area and inserting the tissue expander and port into the incision. A tissue core containing anchored lesions may be created. To remain consistent with the present invention, the ablation device 1100 may be used to create a tissue core, attach the tissue core and seal the tissue core and sever it from the surrounding tissue as previously described. The tissue core may then be removed from the channel. For example, an orifice may be inserted in the channel to facilitate subsequent treatment of the target lesion, such as radiation, by chemotherapy and/or energy-based tumor disappearance. As a further example, the lumen port may be disposed on the perimeter of the tissue resecting device. The orifice may remain in place or may be removed when the device is removed from the tissue site.
The anchors described in fig. 5 are suitable for use in performing the tissue lesion removal methods described herein. The anchor includes an outer tube 1422 having a sufficiently sharp edge to pierce thoracic tissue and lungs without undue damage, and an inner tube 1424 disposed within the outer tube 1422. One or more teeth or fingers formed from a shape memory material 1426, such as nitinol, are pre-formed to be attached to the end of the inner tube 1424. The outer tube 1422 is telescopically disposed over the inner tube 1424 such that when the outer tube 1422 is retracted, the teeth 1426 take on the preform shape as shown in FIG. 1. To remain consistent with the present disclosure, the outer tube 1422 is retracted after penetrating the lung lesion, thereby causing the teeth 1426 to engage the lung lesion. Other suitable anchors can include coils and suction-based structures.
The incision blade illustrated in fig. 6 is suitable for use in performing the tissue lesion removal methods described herein. Once the anchor 1400 is deployed, a small incision or incision is preferably created to facilitate insertion of the chest wall tissue expander. The slitting blade 1605 is used to make wider slits. The incision blades 1605 may be continuous and may include a central aperture that allows them to advance coaxially along the anchor needle 1405 to form a wider incision in the chest wall, each continuous blade being larger than the previous blade, thereby increasing the width of the incision.
The tissue expander depicted in fig. 7 is suitable for use in performing the methods of resecting tissue lesions described herein. The tissue expander may comprise any suitable means for creating a channel in the organic tissue. In one exemplary embodiment, the tissue expander assembly comprises a single cylindrical rod 1510 having rounded ends or a cylindrical rod 1515 having rounded ends and a rigid sleeve. Successive tissue dilators are advanced coaxially along the anchor needle to form a bundle or channel of tissue in the chest wall, each successive dilator being larger than the previous dilator, thereby increasing the diameter of the channel. Once the final dilator with the rigid cannula is used, the inner rod 1505 is removed, leaving the rigid cannula in the intercostal space between the ribs to form a channel directly through to the lung pleura.
Any tissue ablation device capable of penetrating lung tissue and producing a tissue core comprising a target lesion is suitable for performing the tissue lesion removal methods described herein. Tissue ablation device 1100 described herein is preferred.
Once the tissue ablation device 1100 is removed, a small passageway exists in the lung where the target lesion is removed. Depending on the outcome of the tissue diagnosis, the channel may be used to introduce an energy-based ablation device and/or localized chemotherapy. Thus, the methods and systems of the present invention may be used not only to ensure that an effective biopsy is performed, but also to completely ablate lesions with minimal healthy lung tissue removal.
Fig. 8 shows a flow chart of an example method. At 1802, tissue of the target site may be cored such that a tissue core is removed from the target site, thereby creating a core cavity at the target site. Coring tissue at the target site may include transecting and sealing tissue. Coring tissue at a target site may include positioning a coring tissue device adjacent to the target tissue site. The coring tissue device may comprise: a first clamping element comprising a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes for delivering radio frequency energy for sealing tissue, and/or a cutting element for transecting at least a portion of the sealed tissue that is severed. Other means may be used.
At 1804, a tissue resecting device may be positioned at the target tissue site. The target tissue site may include diseased tissue. Various tissues may be included as target sites. The tissue resecting device may comprise one or more of the devices or assemblies described herein.
At 1806, the tissue core may be resected. The tissue core may have a prescribed (e.g., predefined) shape (e.g., columnar) and a size based on the coring device. Such coring devices may core tissue cores of the same or substantially the same shape in a repeatable manner. Such coring may be distinguished from other tissue removal, for example, using scissors or a scalpel, where the cut tissue will not have a predefined shape or size. As an example, the tissue ablation device may cause the ablation of a tissue core from a target tissue site.
At 1808, the tissue resecting device may be removed from the body or a core cavity may be created at the target tissue site. As the tissue core is removed, biological fluid may flow to or into the core cavity.
At 1810, at least a portion of the core cavity may be sealed. Such seals may include seals for biological fluid containers. The sealed biological fluid container minimizes the flow of biological fluid into the cavity core.
The invention at least comprises the following technical proposal:
technical solution 1. A tissue resecting device configured for coring tissue, the device comprising: a first clamping element comprising a helical coil; a second clamping element positioned opposite at least a portion of the first clamping element; a first electrode and a second electrode configured to deliver radiofrequency energy to one or more regions adjacent the first clamping element and the second clamping element to seal tissue; and a cutting element configured for transecting at least a portion of the sealing tissue.
Technical solution 2. A method of using the tissue ablation device of claim 1, the method comprising: rotating the helical coil into the target tissue site; clamping the first clamping element and the second clamping element to each other; energizing the radio frequency energy to one or more first electrodes and second electrodes; and causing the cutting element to core at least a portion of the target tissue site.
Technical solution 3. The tissue excision device is claim 1, further comprising: a first actuator operable to actuate the first or second clamping element to apply mechanical compression to tissue; a second actuator operable to actuate the cutting element to transect the tissue.
Technical solution 4. The tissue resecting device is claim 1, wherein the helical coil comprises first and second continuous coil segments.
Technical solution 5. The tissue resecting device of claim 4 wherein the first coil section comprises a generally planar open loop.
Technical solution 6. The tissue cutting device is claim 5, wherein the first coil section is helical and has zero pitch.
Technical solution 7. The tissue resecting device is claim 4, wherein the second coil section is helical and has a non-zero pitch.
Technical scheme 8. The tissue resecting device of claim 7, wherein the second coil section has a variable pitch.
Technical solution 9. The tissue resecting device of claim 4 wherein the first coil section is helical and has a first pitch, the second coil section is helical and has a second pitch, and at least one of the first and second pitches is variable.
Technical solution 10. The tissue resecting device is claim 1, wherein the first electrode is provided by at least a portion of the first clamping element.
Technical solution 11. The tissue resecting device of claim 1 wherein the second electrode is provided by at least a portion of the second clamping element.
Technical solution 12. The tissue resecting device of claim 1, wherein the helical coil comprises a blunt tip.
Technical solution 13. The tissue resecting device is claim 1, wherein the first and second electrodes have substantially matching surface profiles.
Technical solution 14. The tissue resecting device is claim 1, wherein at least a portion of the resecting element comprises a sharpened edge.
Technical solution 15. Aspects of the tissue ablation device are 1, wherein the ablation element includes at least one electrode configured to deliver radiofrequency energy.
Technical solution 16. The tissue resecting device is claim 1, wherein the resecting element comprises an ultrasonic blade.
Technical solution 17. Aspects of the tissue ablation device are 1, further comprising a second ablation element configured to sever a tissue core from a target tissue site.
Technical solution 18. The tissue resecting device of claim 17 wherein at least a portion of the second resecting element comprises a sharpened edge.
Technical solution 19. The tissue ablation device of claim 17, wherein the second ablation element includes at least one electrode configured to deliver radiofrequency energy.
Technical solution 20. The tissue resecting device of claim 17 wherein the second resecting element comprises an energized lead.
Technical solution 21. The tissue resecting device of claim 17 wherein the second resecting element comprises a suture.
Technical solution 22. The tissue ablation device of claim 17, further comprising an actuator operable to actuate the second ablation element to transect the tissue.
Technical solution 23. A method of coring tissue, the method comprising: disposing a tissue resecting device at a target tissue site; causing the tissue resecting device to resect a tissue core from the target tissue site; and removing the tissue core from the body, wherein removing the tissue core from the body creates a core cavity at the target tissue site.
Technical solution 24. The method according to claim 23, wherein the tissue core comprises at least a portion of a diseased tissue.
Technical solution 25. The method of claim 23, further comprising providing a cannula to access the target tissue site.
Technical solution 26. The method of claim 25, wherein the treatment cannula is effected prior to resecting the tissue core from the body.
Technical solution 27. The method of claim 25, wherein said disposing said cannula is performed after removing the tissue core from the body.
Technical solution 28. The method of claim 25, wherein the cannula comprises a deployable penetrator.
Technical solution 29. The method of claim 25, wherein the cannula comprises an electrode configured to seal or ablate an adjacent target tissue site.
Technical solution 30. The method of claim 25, wherein the cannula comprises a radiofrequency electrode configured to seal or ablate an adjacent target tissue site with radiofrequency energy.
Technical solution 31. The method of claim 23, further comprising delivering radio frequency energy to at least a portion of the wall defining the core cavity.
Technical solution 32. The method of claim 23, further comprising delivering chemotherapy to at least a portion of the wall defining the core cavity.
Technical solution 33. The method of claim 23, further comprising delivering microwave energy to at least a portion of a wall defining the core cavity.
Technical solution 34. The method of claim 23, further comprising transferring thermal energy to at least a portion of a wall defining the core cavity.
Technical solution 35. The method of claim 23, further comprising transmitting ultrasonic energy to at least a portion of the wall defining the core cavity.
Technical solution 36. The method of claim 23, wherein the tissue resecting device is configured to deliver radiofrequency energy.
Technical solution 37. The method of claim 23, wherein the tissue resecting device is configured for mechanical rotary cutting.
Technical solution 38. The method of claim 23, wherein the tissue resecting device is configured for mechanical compression and delivery of radio frequency energy.
Technical solution 39. The method of claim 23, wherein resecting the tissue core from the target tissue site comprises mechanical ablation.
Technical solution 40. The method of claim 23, wherein resecting the tissue core from the target tissue site comprises delivering radio frequency energy.
Technical solution 41. The method of claim 23, wherein resecting the tissue core from the target tissue site comprises mechanical compression and delivery of radio frequency energy.
Technical solution 42. The method of claim 23, wherein resecting the tissue core from the target tissue site comprises mechanical compression, delivery of radio frequency energy, and mechanical ablation.
Technical solution 43. The method of claim 23, wherein resecting the tissue core from the target tissue site comprises transecting with an energized lead.
Technical solution 44. The method of claim 23, further comprising sealing the biological fluid container.
Technical solution 45. The method of claim 44, wherein sealing the biological fluid container minimizes the flow of biological fluid into the cavity core.
Technical solution 46. The method of claim 44, wherein the sealing is accomplished using at least mechanical compression.
Technical solution 47. The method of claim 44, wherein at least radio frequency energy is used to affect the seal.
Technical solution 48. The method of claim 44, wherein at least microwave energy is used to affect the seal.
Technical solution 49. The method of claim 44, wherein the sealing is achieved using at least ultrasonic energy.
Technical solution 50. A method of coring tissue, the method comprising: providing a tissue ablation device at a target tissue site, wherein the tissue ablation device comprises: a first clamping element comprising a helical coil and a first electrode, and a second clamping element comprising a second electrode, the second clamping element being positioned opposite at least a portion of the first clamping element; causing the tissue resecting device to resect a tissue core from the target tissue site; and removing the tissue core from the body, wherein removing the tissue core from the body creates a core cavity at the target tissue site.
Technical solution 51. The method according to claim 50, wherein the tissue core comprises at least a portion of a diseased tissue.
Technical solution 52. The method of claim 50, further comprising inserting a sleeve into the core cavity to support a wall of the core cavity.
Technical solution 53. The method of claim 50, further comprising delivering radio frequency energy to at least a portion of a wall defining the core cavity.
Technical solution 54. The method of claim 50, further comprising delivering chemotherapy to at least a portion of a wall defining the core cavity.
Technical solution 55. The method of claim 50, further comprising delivering microwave energy to at least a portion of a wall defining the core cavity.
Technical solution 56. The method of claim 50, further comprising transferring thermal energy to at least a portion of a wall defining the core cavity.
Technical solution 57. The method of claim 50, further comprising transmitting ultrasonic energy to at least a portion of a wall defining the core cavity.
Technical solution 58. The method of claim 50, wherein the tissue ablation device is configured to deliver radiofrequency energy.
Technical solution 59. The method of claim 50, wherein the tissue resecting device is configured for mechanical rotary cutting.
Technical solution 60. The method of claim 50, wherein the tissue resecting device is configured for mechanical compression and delivery of radio frequency energy.
Technical solution 61. The method of claim 50, wherein resecting the tissue core from the target tissue site comprises mechanical ablation.
Technical solution 62. The method of claim 50, wherein resecting the tissue core from the target tissue site comprises delivering radio frequency energy.
Technical solution 63. The method of claim 50, wherein resecting the tissue core from the target tissue site comprises mechanical compression and delivery of radio frequency energy.
Technical solution 64. The method of claim 50, wherein resecting the tissue core from the target tissue site comprises mechanical compression, delivery of radio frequency energy, and mechanical ablation.
Technical solution 65. The method of claim 50, wherein resecting the tissue core from the target tissue site comprises transecting with an energized lead.
Technical solution 66. The method of claim 50, further comprising sealing the biological fluid container.
Technical solution 67. The method of claim 66, wherein sealing the biological fluid container minimizes the flow of biological fluid into the cavity core.
Technical solution 68. The method of claim 66, wherein the sealing is accomplished using at least mechanical compression.
Technical solution 69. The method of claim 66, wherein sealing is accomplished using at least radio frequency energy.
Technical solution 70. The method of claim 66, wherein at least microwave energy is used to affect the seal.
Technical solution 71. The method of claim 66, wherein at least ultrasonic energy is used to effect the sealing.
Technical solution 72. A method of sealing a biological fluid container, the method comprising: piercing a target tissue site with a helical tissue sealing mechanism, wherein the helical tissue sealing mechanism comprises a helical piercing element and at least one clamping element; applying mechanical compression to at least a portion of at least one target biological fluid container within the target tissue site; and causing the helical tissue sealing mechanism to seal the at least one target biological fluid container.
Technical solution 73. The method of claim 72, wherein the helical puncturing element comprises at least one clamping element.
Technical solution 74. The method is set forth in claim 72 wherein the mechanical compression is applied by adjusting the relative positions of the helical puncturing element and the clamping element.
Technical solution 75. The method of claim 72, further comprising a second clamping element.
Technical solution 76. The method of claim 75, wherein the applying mechanical compression is accomplished by adjusting the relative positions of the first and second clamping elements.
Technical solution 77. The method of claim 72, wherein the sealing of the at least one target biological fluid container minimizes the flow of biological fluid through the at least one target biological fluid container.
Technical solution 78. The method of claim 72, wherein the sealing is accomplished using at least mechanical compression.
Technical solution 79. The method of claim 72, wherein the sealing is achieved using at least radio frequency energy.
Technical solution 80. The method of claim 72, wherein at least microwave energy is used to affect the seal.
Technical solution 81. The method of claim 72, wherein the sealing is achieved using at least ultrasonic energy.
Technical solution 82. A tissue resecting device configured for coring tissue, the device comprising: a first clamping element having a helical coil disposed at a distal end; a second clamping element positioned opposite at least a portion of the first clamping element; the first and second electrodes are configured to deliver radiofrequency energy, e.g., for sealing tissue; and a cutting element configured to transect at least a portion of tissue, such as sealed tissue, at the target site.
Technical solution 83. The tissue resecting device of claim 82, further comprising: a first actuator operable to actuate the first or second clamping element to apply mechanical compression to the tissue; a second actuator operable to actuate the cutting element to transect the tissue.
Technical solution 84. The tissue resecting device of claim 82 wherein the helical coil comprises first and second continuous coil segments.
Technical solution 85. The tissue ablation device of claim 84, wherein the first coil section generally comprises a planar open loop.
Technical solution 86. The tissue resecting device of claim 85 wherein the first coil section is helical and has zero pitch.
Technical solution 87. The tissue resecting device of claim 84 wherein the second coil segment is helical and has a non-zero pitch.
Technical solution 88. The tissue resecting device of claim 87 wherein the second coil section has a variable pitch.
Technical solution 89. The tissue resecting device of claim 84 wherein the first coil section is helical and has a first pitch, the second coil section is helical and has a second pitch, and at least one of the first and second pitches is variable.
Technical solution 90. The tissue resecting device of claim 82 wherein the first electrode is provided by at least a portion of a helical coil.
Technical solution 91. The tissue resecting device of claim 82 wherein the first electrode is provided by at least a portion of the first clamping element.
Technical solution 92. The tissue resecting device of claim 82 wherein the second electrode is provided by at least a portion of the second clamping element.
Technical solution 93. The tissue resecting device of claim 82 wherein the helical coil comprises a blunt tip.
Technical solution 94. The tissue resecting device of claim 82 wherein the first and second electrodes have substantially matching surface profiles.
Technical solution 95. The tissue ablation device of claim 82, wherein at least a portion of the ablation element comprises a sharpened edge.
Technical solution 96. The tissue ablation device of claim 82, wherein the ablation element includes at least one electrode configured to deliver radiofrequency energy.
Technical solution 97. The tissue ablation device of claim 82, wherein the ablation element comprises an ultrasonic blade.
Technical solution 98. The tissue resecting device of claim 82 further comprising a second resecting element configured to sever a tissue core from a target tissue site.
Technical solution 99. The tissue ablation device of claim 98, wherein at least a portion of the second ablation element includes a sharpened edge.
Technical solution 100. The tissue ablation device of claim 98, wherein the second ablation element includes at least one electrode configured to deliver rf energy.
Technical solution 101. The tissue resecting device of claim 98 wherein the second resecting element comprises an energized lead.
Technical solution 102. The tissue cutting device of claim 98, wherein the second cutting element comprises a suture.
Technical solution 103. The tissue ablation device of claim 98, further comprising an actuator operable to actuate the second ablation element to transect the tissue.
Technical solution 104. The tissue resecting device of claim 82, further comprising: a first connection element and a second connection element; and a second cutting element located between the first and second connecting elements.
Technical solution 105. The tissue resecting device of claim 104 wherein the first and second connection elements comprise first and second connection electrodes configured to deliver radio frequency energy.
Technical solution 106. The tissue resecting device of claim 104 wherein the second resecting element is configured to transect tissue between the first and second connecting elements.
Technical solution 107. The tissue resecting device of claim 82 further comprising a snare element.
Technical solution 108. The tissue resecting device of claim 107 wherein the snare element comprises a flexible wire configured for tissue ligation.
Technical solution 109. The tissue resecting device of claim 107 wherein the snare element comprises a flexible wire configured to transect tissue.
Technical solution 110. The tissue resecting device of claim 107 further comprising a circumferential channel path, the snare element being disposed in the circumferential channel.
Technical solution 111. A tissue resecting device configured for coring tissue, the device comprising: a first clamping element comprising a helical coil and a first electrode; a second clamping element comprising a second electrode, the second clamping element being positioned opposite at least a portion of the first clamping element; wherein the first and second clamping elements are configured to: (a) For delivering radiofrequency energy for sealing tissue, and (b) for mechanical compression transecting tissue.
Technical solution 112. The tissue resecting device of claim 111 further comprising an actuator operable to actuate the first or second clamping element to apply mechanical compression to the tissue.
Technical solution 113. The tissue resecting device of claim 111 wherein the helical coil comprises a first coil and a second continuous coil segment.
Technical solution 114. The tissue ablation device of claim 113, wherein the first coil section generally comprises a planar open loop.
Technical solution 115. The tissue resecting device of claim 114 wherein the first coil section is helical and has zero pitch.
Technical solution 116. The tissue resecting device of claim 113 wherein the second coil segment is helical and has a non-zero pitch.
Technical solution 117. The tissue resecting device of claim 116 wherein the second coil segment has a variable pitch.
Technical solution 118. The tissue resecting device of claim 113 wherein the first coil section is helical and has a first pitch, the second coil section is helical and has a second pitch, and at least one of the first and second pitches is variable.
Technical solution 119. The tissue resecting device of claim 111 wherein the first electrode is provided by at least a portion of a helical coil.
Technical solution 120. The tissue resecting device of claim 111 wherein the helical coil comprises a blunt tip.
Technical solution 121. The tissue resecting device of claim 111 wherein the first and second clamping elements have substantially matching surface profiles.
Technical solution 122. The tissue resecting device of claim 111 further comprising a resecting element.
Technical solution 123. The tissue ablation device of claim 122, wherein at least a portion of the ablation element comprises a sharpened edge.
Technical solution 124. The tissue ablation device of claim 122, wherein the ablation element comprises at least one electrode configured to deliver rf energy.
Technical solution 125. The tissue ablation device of claim 122, wherein the ablation element comprises an ultrasonic blade.
Technical solution 126. The tissue resecting device of claim 122, further comprising a second resecting element configured to sever a tissue core from a target tissue site.
Technical solution 127. The tissue ablation device of claim 126, wherein at least a portion of the second ablation element includes a sharpened edge.
Technical solution 128. The tissue ablation device of claim 126, wherein the second ablation element includes at least one electrode configured to deliver rf energy.
Technical solution 129. The tissue resecting device of claim 126 wherein the second resecting element comprises an energized lead.
Technical solution 130. The tissue ablation device of claim 126, further comprising an actuator operable to actuate the second ablation element to transect the tissue.
Technical solution 131. A tissue sealing mechanism, comprising: a helical coil having a generally diagonal cross-section and a tapered point disposed at the distal end; first and second helical tissue sealing surfaces, wherein the first and second helical tissue sealing surfaces are provided by parallel planes of the helical coil; a first electrode disposed on the first spiral tissue sealing surface; a second electrode disposed on the second helical tissue-sealing surface, wherein the first and second electrodes are configured to apply bipolar radiofrequency energy for sealing tissue.
Technical solution 132. The tissue sealing mechanism of claim 131, wherein the helical coil comprises first and second continuous coil segments.
Technical solution 133. The tissue sealing mechanism of claim 131, wherein the helical coil comprises a blunt tip.
Technical solution 134. The tissue sealing mechanism of claim 131, wherein the first and second electrodes have substantially matching surface profiles.
Technical solution 135. The tissue sealing mechanism of claim 131, wherein the first and second helical tissue sealing surfaces further comprise a plurality of electrodes for delivering bipolar radiofrequency energy.
While there has been shown and described what are considered to be the most practical and preferred embodiments, it will be apparent to those skilled in the art that departures from the specific designs and methods described and illustrated will suggest themselves to those skilled in the art and may be used without departing from the spirit and scope of the invention. For example, the systems, devices, and methods described herein for removing lesions from the lung. Those skilled in the art will appreciate that the devices and methods described herein may not be limited to the lungs, and may be used for tissue ablation and lesion removal in other parts of the body. The invention is not limited to the specific constructions described and shown, but should be constructed in conformity with all modifications that may fall within the scope of the appended claims.

Claims (60)

1. A tissue resecting device for coring tissue, the device comprising:
a first clamping element comprising a helical coil;
a second clamping element positioned opposite at least a portion of the first clamping element;
first and second electrodes configured to deliver radiofrequency energy to one or more target tissue sites adjacent the first and second clamping elements; and
A resection element configured to resect at least a portion of the target tissue site.
2. A method of using the tissue resecting device of claim 1, the method comprising:
rotating the helical coil to a target tissue site;
clamping the first clamping element and the second clamping element to each other;
energizing the radio frequency energy to one or more first electrodes and second electrodes; and
the cutting element is cored to at least partially target tissue site.
3. The tissue resecting device of claim 1 further comprising:
a first actuator operable to actuate the first or second clamping element to apply mechanical compression to tissue; and
a second actuator operable to actuate the cutting element to transect the tissue.
4. The tissue resecting device of claim 1 wherein the helical coil comprises first and second continuous coil segments.
5. The tissue resecting device of claim 4 wherein the first coil section comprises a generally planar open loop.
6. The tissue resecting device of claim 5 wherein the first coil section is helical and has zero pitch.
7. The tissue resecting device of claim 4 wherein the second coil segment is helical and has a non-zero pitch.
8. The tissue resecting device of claim 7 wherein the second coil segment has a variable pitch.
9. The tissue resecting device of claim 4 wherein the first coil section is helical and has a first pitch, the second coil section is helical and has a second pitch, and at least one of the first and second pitches is variable.
10. The tissue resecting device of claim 1 wherein the first electrode is provided by at least a portion of the first clamping element.
11. The tissue resecting device of claim 1 wherein the second electrode is provided by at least a portion of the second clamping element.
12. The tissue resecting device of claim 1 wherein the helical coil comprises a blunt tip.
13. The tissue resecting device of claim 1 wherein the first and second electrodes have substantially matching surface profiles.
14. The tissue resecting device of claim 1 wherein at least a portion of the resecting element comprises a sharpened edge.
15. The tissue resecting device of claim 1 wherein the resecting element comprises at least one electrode configured to deliver radio frequency energy.
16. The tissue resecting device of claim 1 wherein the resecting element comprises an ultrasonic blade.
17. The tissue resecting device of claim 1 further comprising a second resecting element configured to sever a tissue core from a target tissue site.
18. The tissue resecting device of claim 17 wherein at least a portion of the second resecting element comprises a sharpened edge.
19. The tissue resecting device of claim 17 wherein the second resecting element comprises at least one electrode configured to deliver radio frequency energy.
20. The tissue resecting device of claim 17 wherein the second resecting element comprises an energized wire.
21. The tissue resecting device of claim 17 further comprising an actuator operable to actuate the second resecting element to transect tissue.
22. The tissue resecting device of claim 1 further comprising first and second connection electrodes configured to deliver radio frequency energy to tissue.
23. The tissue resecting device of claim 1 further comprising a snare element configured to pull tissue toward the first and second connection electrodes for sealing the pulled tissue.
24. The tissue resecting device of claim 1 further comprising a snare element comprising one or more flexible wires for attachment of tissue or transection of tissue.
25. The tissue resecting device of claim 1 further comprising a ligating snare configured to collect tissue for sealing at the connection point.
26. The tissue resecting device of claim 24 further comprising a severing snare that severs at least a portion of tissue upstream from the point of attachment.
27. A method of coring tissue, the method comprising:
placing a tissue ablation device at a target tissue site; and
causing the tissue resecting device to resect the tissue core from the target tissue site and removing the tissue core from the body, wherein removing the tissue core from the body creates a core cavity at the target tissue site.
28. The method of claim 27, wherein the tissue core comprises at least a portion of diseased tissue.
29. The method of claim 27, further comprising providing a cannula to provide access to the target tissue site.
30. The method of claim 29, wherein the deploying the cannula is performed prior to removing the tissue core from the body.
31. The method of claim 29, wherein said positioning the cannula is performed after removing the tissue core from the body.
32. The method of claim 29, wherein the cannula comprises a deployable penetrator.
33. The method of claim 29, wherein the cannula comprises an electrode configured to seal or ablate an adjacent target tissue site.
34. The method of claim 29, wherein the cannula comprises a radiofrequency electrode configured to seal or ablate adjacent target tissue sites with radiofrequency energy.
35. The method of claim 27, further comprising delivering radio frequency energy to at least a portion of a wall defining the core cavity.
36. The method of claim 27, further comprising delivering chemotherapy to at least a portion of a wall defining the core cavity.
37. The method of claim 27, further comprising delivering microwave energy to at least a portion of a wall defining the core cavity.
38. The method of claim 27, further comprising transferring thermal energy to at least a portion of a wall defining the core cavity.
39. The method of claim 27, further comprising transmitting ultrasonic energy to at least a portion of a wall defining the core cavity.
40. The method of claim 27, wherein the tissue resecting device is configured to deliver radiofrequency energy.
41. The method of claim 27, wherein the tissue resecting device is configured for mechanical transection.
42. The method of claim 27, wherein the tissue resecting device is configured for mechanical compression and delivery of radio frequency energy.
43. The method of claim 27, wherein said resecting the tissue core from the target tissue site comprises mechanical ablation.
44. The method of claim 27, wherein resecting the tissue core from the target tissue site comprises delivering radio frequency energy.
45. The method of claim 27, wherein resecting the tissue core from the target tissue site comprises mechanical compression and delivery of radio frequency energy.
46. The method of claim 27, wherein resecting the tissue core from the target tissue site comprises mechanical compression, delivery of radio frequency energy, and mechanical ablation.
47. The method of claim 27, wherein resecting the tissue core from the target tissue site comprises transecting with an energizing lead.
48. The method of claim 27, further comprising sealing the biological fluid container.
49. The method of claim 48, wherein sealing the biological fluid container minimizes fluid flow into the cavity core.
50. The method of claim 48, wherein the sealing is accomplished using at least mechanical compression.
51. The method of claim 48, wherein said sealing is accomplished using at least radio frequency energy.
52. The method of claim 48, wherein at least microwave energy is used to effect the sealing.
53. The method of claim 48, wherein the sealing is accomplished using at least one ultrasonic energy.
54. The method of claim 27, wherein the tissue resecting device comprises:
a first clamping element comprising a helical coil and a first electrode; and
a second clamping element including a second electrode, the second clamping element being positioned opposite at least a portion of the first clamping element.
55. A method of sealing a biological fluid container, the method comprising:
piercing a target tissue site with a helical tissue sealing mechanism, wherein the helical tissue sealing mechanism comprises:
a helical puncturing element; and
at least one clamping element;
applying mechanical compression to at least a portion of at least one target biological fluid container within the target tissue site; and
enabling the helical tissue sealing mechanism to seal at least one target biological fluid container.
56. The method of claim 55, wherein the helical puncturing element comprises at least one clamping element.
57. The method of claim 55, wherein applying mechanical compression is accomplished by adjusting the relative positions of the helical puncturing element and the clamping element.
58. The method of claim 55, wherein the helical tissue sealing mechanism comprises at least one of a first and a second clamping element, and wherein applying the mechanical compression is accomplished by adjusting the relative positions of the first and second clamping elements.
59. The method of claim 55, wherein the sealing of the at least one target biological fluid container minimizes the flow of biological fluid through the at least one target biological fluid container.
60. The method of claim 55, wherein sealing is achieved using one or more of mechanical extrusion, radio frequency energy, microwave energy, or ultrasonic energy.
CN202180032065.2A 2020-04-30 2021-04-29 Systems, devices, and methods for coring tissue Pending CN116528780A (en)

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