US20090093758A1 - Fibroid treatment apparatus and method - Google Patents

Fibroid treatment apparatus and method Download PDF

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Publication number
US20090093758A1
US20090093758A1 US11591044 US59104406A US2009093758A1 US 20090093758 A1 US20090093758 A1 US 20090093758A1 US 11591044 US11591044 US 11591044 US 59104406 A US59104406 A US 59104406A US 2009093758 A1 US2009093758 A1 US 2009093758A1
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balloon
configured
patient
apparatus according
uterine artery
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Abandoned
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US11591044
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Yossi Gross
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Gross Yossi
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Yossi Gross
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42Gynaecological or obstetrical instruments or methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12009Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065Functions of balloons
    • A61B2017/22067Blocking; Occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0001Catheters; Hollow probes for pressure measurement
    • A61M2025/0002Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0037Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0194Tunnelling catheters
    • A61M2025/0197Tunnelling catheters for creating an artificial passage within the body, e.g. in order to go around occlusions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1052Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1054Balloon catheters with special features or adapted for special applications having detachable or disposable balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1061Balloon catheters with special features or adapted for special applications having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape

Abstract

Apparatus is provided, including a tube that is passed into a patient's vagina and to penetrate vaginal tissue until a distal tip of the tube is outside of a uterine artery of the patient, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid. A balloon, disposed at the distal tip, is inflated to cause local squeezing of the portion of the uterine artery to an extent sufficient to occlude the uterine artery. Other embodiments are also described.

Description

    CROSS-REFERENCES TO RELATED APPLICATIONS
  • The present application claims priority from U.S. Provisional Patent Application No. 60/820,130 to Gross, filed Jul. 24, 2006, entitled, “Fibroid treatment apparatus and method,” which is incorporated herein by reference.
  • FIELD OF THE INVENTION
  • The present invention relates generally to treatment of fibroids, and, specifically, to reduction of fibroids by uterine artery occlusion.
  • BACKGROUND OF THE INVENTION
  • Uterine fibroids are benign tumors of muscle and connective tissue that develop within, or are attached to, the uterine wall.
  • Vascular Control Systems (San Juan Capistrano, Calif.) has developed a device called the Flostat. According to the company, the primary element of the Flostat system is a Doppler guided clamp designed for bilateral temporary occlusion of the uterine arteries. The device is currently indicated for use during conservative gynecologic procedures such as laparoscopic myomectomy.
  • U.S. Pat. No. 6,764,488 to Burbank et al. and US Patent Application Publication 2003/0216759 to Burbank et al., which are incorporated herein by reference, describe devices and methods for treating a uterine pathology which receives its blood supply from a uterine artery. In particular, uterine fibroids are described as being effectively treated by occluding the uterine arteries using trans-vaginal, trans-uterine, transrectal, or retroperitoneal approaches. The devices and methods are intended for performance by a patient's gynecologist in the course of treatment, avoiding the need for (a) referrals to specialist practitioners and (b) other treatments, such as hysterectomy. The methods include both temporary and permanent occlusion of the arteries. A cannula carries an imaging device and a member which penetrates tissue, the member including a device which partially or completely, and temporarily or permanently, occludes a uterine artery.
  • US Patent Application Publication 2005/0113852 to Burbank et al., which is incorporated herein by reference, describes an intravaginal uterine artery occlusion device for treating uterine disorders such as fibroids, dysfunctional uterine bleeding, postpartum hemorrhage and the like. An occlusion device has a cervical receptacle or cap with an open distal end for receiving the patient's uterine cervix and an elongated shaft having a distal end secured to the closed proximal end of the cervical receptacle and an inner lumen extending to the distal end of the elongated shaft. The patient's uterine cervix is held within the interior of the receptacle by the application of a vacuum to the interior of the receptacle through the inner lumen of the shaft or otherwise, while the leading edge(s) of the cervical receptacle press against the patient's vaginal fornix to occlude an underlying or adjacent uterine artery. At least one blood flow sensor may be provided on the leading edge of the receptacle to aid in locating a uterine artery and to monitor blood flow through the located uterine artery. FIG. 7 of the '852 publication illustrates the device positioned within the patient, with a side expansion balloon expanded inwardly to press against the vaginal fornix to ensure the occlusion of the patient's left uterine artery.
  • US Patent Application Publication 2006/0000479 to Burbank et al., which is incorporated herein by reference, describes non-permanent occlusion of the uterine arteries as being sufficient to cause the demise of uterine myomata without unnecessarily exposing other tissues and anatomical structures to hypoxia attendant to prior permanent occlusion techniques. A therapeutically effective transient time of occlusion of a uterine artery to treat uterine fibroid tumors is from 1 hours to 24 hours, and preferably is at least about 4 hours. A therapeutically effective temporary time of occlusion of a uterine artery to treat uterine fibroid tumors is from 1 day (24 hours) to 7 days (168 hours), and preferably is about 4 days (96 hours). By invaginating the tissues of the vaginal wall up to or around a uterine artery, collapse of the uterine artery is described as being achievable without penetrating tissue of the patient.
  • US Patent Application Publication 2004/0097788 to Mourlas et al., which is incorporated herein by reference, describes apparatus for locating morphological features within a body cavity. The apparatus includes a catheter including proximal and distal ends, a transparent balloon carried on the distal end, and an optical imaging assembly carried on the distal end for imaging through the balloon. The balloon includes a channel extending therethrough to a lumen extending through the catheter. A guidewire or other localization member is received in the lumen that is extendable through the channel. During use, the catheter is inserted into a right atrium of a heart, and the balloon is expanded and placed against the wall of the heart to locate the coronary sinus. Sufficient force is applied to clear blood between the surface and the wall and clear the field of view of the imaging assembly. The catheter is manipulated to locate the coronary sinus, whereupon the localization member is advanced into the coronary sinus.
  • SUMMARY OF THE INVENTION
  • In some embodiments of the present invention, apparatus for treating a patient's uterine fibroid comprises a tube, configured to be passed into the patient's vagina. The tube penetrates vaginal tissue until a distal tip of the tube is outside of a uterine artery of the patient, but in a vicinity of a portion of the uterine artery that supplies the fibroid. A balloon is configured to be disposed at the distal tip, and to be inflated to cause local squeezing of the portion of the uterine artery to an extent sufficient to occlude the uterine artery.
  • Although some patients or physicians may choose to carry out embodiments of the present invention in conjunction with lumbar puncture, some embodiments of the present invention do not require lumbar puncture, and, indeed, allow the patient to move around in bed or be completely mobile while the balloon is squeezing the uterine artery.
  • There is therefore provided, in accordance with an embodiment of the present invention, apparatus including:
  • a tube, configured to be passed into a patient's vagina and to penetrate vaginal tissue until a distal tip of the tube is outside of a uterine artery of the patient, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid; and
  • a balloon, configured to be disposed at the distal tip and to be inflated to cause local squeezing of the portion of the uterine artery to an extent sufficient to occlude the uterine artery.
  • In an embodiment, the tube is configured to be passed into the patient's vagina during a medical procedure, and the balloon is configured to be removed from the patient during the same medical procedure.
  • In an embodiment, at least a portion of the balloon allows light to pass therethrough, and the apparatus includes a scope configured to permit visualization, through the portion of the balloon, of tissue beyond the balloon.
  • In an embodiment, the apparatus includes an endpoint indicator, configured to generate a signal indicative of a desired endpoint of the occluding of the uterine artery.
  • In an embodiment, the endpoint indicator includes a temperature sensor, suitable for measuring a temperature of the fibroid.
  • In an embodiment, the endpoint indicator includes a timer.
  • In an embodiment, the balloon is configured to deflate in response to the signal generated by the endpoint indicator.
  • In an embodiment, the apparatus is configured such that the tube can be separated from the balloon and removed from the patient while the balloon remains, inflated, within the patient.
  • In an embodiment, the balloon includes a valve, through which the tube inflates the balloon, and which inhibits deflation of the balloon after separation of the balloon from the tube.
  • In an embodiment, the balloon is configured for deflation within the patient following the squeezing, and to reside chronically within the patient.
  • In an embodiment, the balloon is configured for removal from the patient following the deflation.
  • In an embodiment, the apparatus includes an extractor, coupled to the balloon, configured to reside in part within the patient's vagina while the balloon is causing the local squeezing, and configured to facilitate extraction of the balloon from the patient.
  • In an embodiment, the apparatus includes a sensor, configured to generate a signal that is indicative of proximity of the distal tip to the uterine artery.
  • In an embodiment, the sensor includes an acoustic sensor.
  • In an embodiment, the sensor includes a pressure sensor.
  • In an embodiment, the pressure sensor is configured to operate substantially without transmitting energy towards the uterine artery.
  • In an embodiment, the balloon is shaped to define an orifice that is configured to release contents of the balloon into a body of the patient, when the balloon is within the patient.
  • In an embodiment, the apparatus includes saline, configured for placement within the balloon and to be at least a portion of the contents of the balloon released into the body of the patient.
  • In an embodiment, the apparatus includes a pharmaceutical product, configured for placement within the balloon and to be at least a portion of the contents of the balloon released into the body of the patient.
  • In an embodiment, the pharmaceutical product includes an anesthetic.
  • In an embodiment, the pharmaceutical product includes a pharmaceutical selected from the group consisting of: an anti-inflammatory agent, and an antibiotic.
  • In an embodiment, the balloon and orifice are configured such that the release of the contents occurs over a time period that lasts for at least 30 minutes.
  • In an embodiment, the time period is at least 3 hours, and the balloon and orifice are configured such that the release of the contents occurs over the time period that lasts at least 3 hours.
  • In an embodiment, the balloon and orifice are configured such that the release of the contents reduces a volume of the balloon at an average rate of between 1%/hour and 30%/hour, calculated over a 30 minute period.
  • In an embodiment, the balloon and orifice are configured such that the average rate is between 1%/hour and 5%/hour.
  • In an embodiment, the balloon and orifice are configured such that the average rate is between 5%/hour and 15%/hour.
  • In an embodiment, the balloon and orifice are configured such that the average rate is between 15%/hour and 30%/hour.
  • In an embodiment, the balloon is configured to remain within the patient for at least 7 days following termination of the occlusion.
  • In an embodiment, at least a portion of the balloon is biodegradable.
  • In an embodiment, at least a portion of the balloon is not biodegradable.
  • In an embodiment, the balloon is configured to deflate, without active human intervention, while within the patient.
  • In an embodiment, the balloon includes a biodegradable deflation element, configured such that degrading of the biodegradable deflation element causes the deflation of the balloon.
  • In an embodiment, the balloon is configured to deflate at a time that is at least 1 hour after inflation of the balloon.
  • In an embodiment, the apparatus includes:
  • an inflation sensor, configured to generate a signal indicative of a level of inflation of the balloon; and
  • an indicator, configured to generate an indication to a human of the level of inflation.
  • In an embodiment, the inflation sensor includes a pressure sensor, configured to generate the signal in response to a level of pressure in the balloon.
  • In an embodiment, the inflation sensor includes a sensor configured to generate the signal in response to a characteristic of blood flow in the uterine artery.
  • In an embodiment:
  • the inflation sensor is configured to be attached to the balloon, and
  • the indicator is configured to be disposed outside of a body of the patient and to receive the signal wirelessly from the inflation sensor.
  • In an embodiment, the balloon includes an active deflation element, configured to actively cause the deflation of the balloon.
  • In an embodiment, the active deflation element includes at least one element selected from the group consisting of: a puncturing element, and a heating element.
  • In an embodiment, the apparatus includes an endpoint indicator, configured to generate a signal indicative of a desired endpoint of the occluding of the uterine artery, and the active deflation element is configured to cause the deflation of the balloon in response to the signal.
  • In an embodiment, the active deflation element is configured to cause the deflation at a designated time after the occluding of the uterine artery.
  • In an embodiment, the balloon is configured to deflate at a time that is less than 36 hours after inflation of the balloon.
  • In an embodiment, the balloon is configured to deflate at a time that is at least 1 hour after inflation of the balloon.
  • In an embodiment, the balloon is configured to deflate at a time that is between 5 hours and 20 hours after inflation of the balloon.
  • There is further provided, in accordance with an embodiment of the present invention, a method including:
  • advancing a tool to a site within a patient, outside of a vagina of the patient and outside of a uterine artery of the patient, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid; and
  • squeezing the portion of the uterine artery with the tool, to an extent sufficient to occlude the uterine artery.
  • In an embodiment, the tool includes a tube and a balloon coupled to the tube, and squeezing the portion of the uterine artery includes inflating the balloon.
  • In an embodiment, the method does not include performing lumbar puncture.
  • In an embodiment, the method includes identifying attainment of a desired endpoint of the occluding of the uterine artery.
  • In an embodiment, the method includes measuring a temperature of the fibroid, and identifying includes identifying the attainment of the desired endpoint in response to the measured temperature.
  • In an embodiment, identifying the attainment of the desired endpoint includes comparing an actual duration of occlusion of the uterine artery to a desired duration of occlusion of the uterine artery.
  • In an embodiment, the method includes terminating the squeezing in response to the identifying.
  • In an embodiment, terminating includes withdrawing the tool from the patient.
  • In an embodiment, the method includes, subsequently to the terminating, maintaining at least a portion of the tool within the patient for at least 7 days.
  • In an embodiment, the method includes terminating the squeezing, without active human intervention, while the tool is within the patient.
  • In an embodiment, terminating the squeezing includes terminating the squeezing in response to biodegrading of a biodegradable deflation element.
  • In an embodiment, terminating the squeezing includes terminating the squeezing at a time that is at least 1 hour after an initiating of the squeezing.
  • In an embodiment, the method includes:
  • sensing an indication of whether the squeezing has terminated; and
  • outputting a signal to a human in response to the sensing.
  • In an embodiment, sensing includes sensing a pressure.
  • In an embodiment, sensing includes sensing a characteristic of blood flow in the uterine artery.
  • In an embodiment, the method includes removing the tool from the patient in response to an indication by the outputted signal that the squeezing has terminated.
  • In an embodiment, the method includes assessing a duration during which the portion of the uterine artery was occluded, and squeezing the portion of the uterine artery again if the assessed duration is determined to be too short.
  • In an embodiment, the method includes discharging the patient from a healthcare facility at least in part in response to an indication by the outputted signal that the squeezing has terminated.
  • In an embodiment, terminating the squeezing includes actuating an active element to cause the squeezing to terminate.
  • In an embodiment, the method includes sensing attainment of a desired endpoint of the occluding of the uterine artery, and actuating the active element includes actuating the active element in response to the sensing.
  • In an embodiment, actuating the active element includes at least one action selected from the group consisting of: puncturing the tool, and heating the tool.
  • In an embodiment, actuating the active element includes actuating the active element at a designated time after the occluding of the uterine artery.
  • In an embodiment, terminating the squeezing includes terminating the squeezing at a time that is less than 36 hours after an initiating of the squeezing.
  • In an embodiment, terminating the squeezing includes terminating the squeezing at a time that is at least 1 hour after an initiating of the squeezing.
  • In an embodiment, terminating the squeezing includes terminating the squeezing at a time that is between 5 hours and 20 hours after an initiating of the squeezing.
  • In an embodiment, the method includes terminating the squeezing of the portion of the uterine artery at a termination time, and leaving at least a portion of the tool within the patient for at least 7 days following the termination time.
  • In an embodiment, the portion of the tool includes a balloon, and leaving includes leaving the balloon within the patient.
  • In an embodiment, at least a portion of the balloon is biodegradable, and leaving the balloon includes leaving the balloon to biodegrade within the patient.
  • In an embodiment, at least a portion of the balloon is not biodegradable, and leaving the balloon includes leaving the balloon to reside permanently within the patient.
  • In an embodiment, the tool includes a balloon, and squeezing the portion of the uterine includes inflating the balloon.
  • In an embodiment, at least a portion of the balloon allows light to pass therethrough, and the method includes visualizing, through the portion of the balloon, tissue beyond the balloon.
  • In an embodiment, the method includes sensing an indication of proximity of the tool to the uterine artery.
  • In an embodiment, sensing includes acoustically sensing.
  • In an embodiment, sensing includes sensing a pressure.
  • In an embodiment, sensing the pressure includes sensing the pressure substantially without transmitting energy towards the uterine artery.
  • In an embodiment, the method includes releasing contents of the tool into a body of the patient, when the tool is within the patient.
  • In an embodiment, releasing the contents includes releasing a liquid.
  • In an embodiment, releasing the liquid includes releasing saline.
  • In an embodiment, releasing the contents includes releasing a pharmaceutical product.
  • In an embodiment, releasing the pharmaceutical product includes releasing an anesthetic.
  • In an embodiment, releasing the contents includes releasing the contents over a time period that lasts for at least 30 minutes.
  • In an embodiment, releasing the contents includes releasing the contents over a time period that lasts for at least 3 hours.
  • In an embodiment, releasing the contents includes reducing a volume of the tool at an average rate of between 1%/hour and 30%/hour, calculated over a 30 minute period.
  • In an embodiment, reducing the volume includes setting the average rate to between 1%/hour and 5%/hour.
  • In an embodiment, reducing the volume includes setting the average rate to between 5%/hour and 15%/hour.
  • In an embodiment, reducing the volume includes setting the average rate to between 15%/hour and 30%/hour.
  • There is also provided, in accordance with an embodiment of the invention, apparatus including:
  • a tube, configured to be passed into a patient's vagina and to penetrate vaginal tissue until a distal tip of the tube is outside of a uterine artery of the patient, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid; and
  • a tool, configured to be disposed at the distal tip and to cause local squeezing of the portion of the uterine artery to an extent sufficient to occlude the uterine artery.
  • There is yet further provided, in accordance with an embodiment of the present invention, apparatus including:
  • a tube, configured to be passed into a body of a patient until a distal tip of the tube is outside of an artery of the patient; and
  • a balloon, configured to be disposed at the distal tip and to be inflated to cause local squeezing of a portion of the artery to an extent sufficient to occlude the artery.
  • There is still further provided, in accordance with an embodiment of the present invention, a method including:
  • advancing a balloon to a site within a patient, outside of an artery of the patient; and
  • squeezing the artery by inflating the balloon to an extent sufficient to occlude the artery.
  • There is additionally provided, in accordance with an embodiment of the present invention, a method including:
  • surgically implanting a balloon within a patient; and
  • configuring the balloon to deflate, without human intervention, within 36 hours.
  • There is also provided, in accordance with an embodiment of the invention, a method including:
  • surgically implanting a balloon within a patient, via a vagina of the patient; and
  • configuring the balloon to deflate without human intervention.
  • There is yet further provided, in accordance with an embodiment of the present invention, a method including:
  • placing a balloon and a sensor within a patient, via a vagina of the patient; and
  • receiving from the sensor an indication of a state of inflation of the balloon.
  • There is still further provided, in accordance with an embodiment of the present invention, a method including:
  • placing a balloon and a sensor within a patient;
  • initiating a medical procedure by inflating the balloon; and
  • receiving from the sensor an indication that the procedure has been completed.
  • There is additionally provided, in accordance with an embodiment of the present invention, a method including:
  • placing a balloon within a patient; and
  • configuring the balloon to deflate without human intervention.
  • There is also provided, in accordance with an embodiment of the invention, a method including:
  • implanting a biodegradable balloon within a patient; and
  • initiating a medical procedure by inflating the balloon.
  • The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIGS. 1 and 2 are schematic illustrations of a method and apparatus for treating uterine fibroids, in accordance with an embodiment of the present invention;
  • FIGS. 3A and 3B are schematic illustrations showing details of the apparatus of FIG. 1, in accordance with an embodiment of the present invention;
  • FIGS. 4-6 are schematic illustrations of apparatus for treating uterine fibroids, in accordance with another embodiment of the present invention;
  • FIGS. 7A-C are schematic illustrations of a procedure for placing a portion of the apparatus of FIGS. 4-6, in accordance with an embodiment of the present invention;
  • FIGS. 8-10 are schematic illustrations of apparatus for treating uterine fibroids, in accordance with yet another embodiment of the present invention;
  • FIGS. 11A-C are schematic illustrations of a procedure for placing a portion of the apparatus of FIGS. 8-10, in accordance with an embodiment of the present invention;
  • FIGS. 12A and 12B are schematic illustrations of apparatus for delivering contents of a balloon, in accordance with an embodiment of the present invention; and
  • FIGS. 13A and 13B are schematic illustrations of apparatus for deflating a balloon, in accordance with an embodiment of the present invention.
  • DETAILED DESCRIPTION OF EMBODIMENTS
  • FIGS. 1 and 2 are schematic illustrations of apparatus 20 for treating a fibroid 30 in a uterus 32 of a patient, in accordance with an embodiment of the present invention. Fibroid 30 receives oxygenated blood from a uterine artery 28. Apparatus 20 occludes (i.e., occludes completely, or occludes at least in part) uterine artery 28 with a tool that compresses the artery from a site within the patient's body, outside of the patient's vagina 26 and outside of the artery.
  • In some embodiments of the present invention, apparatus 20 comprises a tool such as a tube 22, configured to be passed into the patient's vagina 26. (Tube 22 may be disposed within another tool, such as a longitudinal carrier 60 shown in detail in FIGS. 3A and 3B.) Tube 22 penetrates vaginal tissue 24 until a distal tip 36 of the tube is outside of uterine artery 28, but in a vicinity of a portion 38 of the uterine artery that supplies fibroid 30. A balloon 40 (FIG. 2) is configured to be disposed at distal tip 36, and to be inflated to cause local squeezing of portion 38 of uterine artery 28, to an extent sufficient to occlude the uterine artery.
  • Artery 28 is typically occluded for a sufficient time to partially or completely destroy fibroid 30, while not causing substantial levels of damage to non-tumor tissue of the patient. As appropriate, techniques and apparatus known in the art and/or described in one or more of the references cited in the Background section of the present patent application may be combined with techniques described herein, mutatis mutandis. For example, cutting and/or tissue penetration tools may be used to facilitate passage of distal tip 36 towards portion 38 of uterine artery 28. Similarly, tube 22 may be advanced through a working channel of an endoscope.
  • FIG. 3A is a schematic illustration showing details of apparatus 20, in accordance with an embodiment of the present invention. It is to be appreciated that the configuration of hardware components in FIG. 3A is shown by way of illustration and not limitation, and that the scope of the present invention includes other apparatus suitable for carrying out the method described herein.
  • Apparatus 20 as shown in FIG. 3A comprises a longitudinal carrier 60 having a plurality of channels. One of these channels typically defines tube 22. Typically, carrier 60 comprises an endoscope, which allows visualization of the environment of distal tip 36. For some applications, balloon 40 is transparent, and light entering the endoscope through a light guide 70 illuminates the environment of distal tip 36. Light reflected from the site passes through balloon 40 and assists a physician operating apparatus 20 to determine whether the balloon has arrived at the desired location. In an embodiment, the image obtained through balloon 40 is displayed on a workstation 74 of apparatus 20.
  • For some applications, apparatus 20 comprises a sensor 72, configured to generate a signal that is indicative of the proximity of distal tip 36 to uterine artery 28. In an embodiment, sensor 72 comprises a pressure sensor in fluid communication with balloon 40 via a channel 66. The proximity of distal tip 36 to uterine artery 28 in this embodiment is typically determined based on the clarity of an arterial pressure trace 76 displayed on workstation 74 and/or the value of a mathematical variable calculated based on the signal. For example, the variable may be based on a fourier transform of the signal, and may represent the percentage of the signal which contains fluctuations near 1 Hz. FIG. 3A show pressure trace 76 clearly varying in a manner characteristic of arterial blood flow, indicating that distal tip 36 is near to but not occluding flow in uterine artery 28.
  • For some applications, sensor 72 comprises an acoustic sensor, whose output is typically channeled through a loudspeaker (not shown) to allow the physician to assess how close distal tip 36 is to uterine artery 28. In this manner, sensor 72 with channel 66 acts in a manner analogous to a stethoscope.
  • It is to be appreciated that the position and mechanical and electrical characteristics of sensor 72 are described herein and shown in the figures by way of illustration and not limitation. For some applications, sensor 72 is otherwise configured, for example, by being located at distal tip 36. In any case, because of the close distance of distal tip 36 to uterine artery 28, sensor 72 typically generates the signal indicative of the proximity of distal tip 36 to uterine artery 28 substantially without using the transmission of energy to the artery and the subsequent collection of reflected energy from the artery. Instead, in these embodiments, sensor 72 senses a parameter in a vicinity of the tip which is indicative of the proximity of the tip to the artery. Alternatively, energy transmission (e.g., ultrasound) is used, at least in part, to facilitate the determination of proximity.
  • FIG. 3B is a schematic illustration of apparatus 20 during operation thereof, in accordance with an embodiment of the present invention. When it is determined that distal tip 36 is sufficiently near to, or in contact with, uterine artery 28, balloon 40 is inflated by a pressure source 50 of apparatus 20. Typically, but not necessarily, the level of inflation of balloon 40 is increased until the signal from sensor 72 (or another sensor) indicates that artery 28 has been occluded. For example, variations in the signal that are approximately 1 Hz may be heard or seen to decrease substantially when the artery has been occluded. Pressure trace 76 in FIG. 3B is seen to be smaller than in FIG. 3A, indicating that the balloon is at least partially occluding the uterine artery.
  • Pressure source 50 typically comprises a manual syringe, as shown, but may alternatively comprise an automatic pressure source, e.g., one that is activated by workstation 74. Pressure source 50 typically inflates balloon with a saline solution, another liquid, or a gas. Inflation of balloon 40 compresses portion 38 of uterine artery 28, thereby occluding the artery and depriving fibroid 30 of its blood supply.
  • Reference is now made to FIGS. 4-6, which are schematic illustrations of apparatus 100 for treating uterine fibroids, in accordance with another embodiment of the present invention. Apparatus 100 is generally similar to apparatus 20 described with reference to FIGS. 1-3, except as described hereinbelow.
  • Apparatus 100 comprises a balloon 102 that is disposed at distal tip 36 during initial placement of apparatus 100 (FIG. 4). Balloon 102 is inflated via a balloon port 104 (FIG. 5). Distal tip 36 is separated from balloon 102 by pulling distal tip 36 in a direction 108 away from the balloon (FIG. 6). When distal tip 36 is separated from balloon 102, a valve 106 of the balloon closes, preventing or inhibiting deflation of the balloon.
  • Reference is now made to FIGS. 7A-C, which are schematic illustrations of a procedure for placing balloon 102 within the patient's body, in accordance with an embodiment of the present invention. The procedure is generally similar to that shown and described with reference to FIGS. 1 and 2, except as noted. Tube 22 penetrates vaginal tissue 24 until apparatus 100 is outside of uterine artery 28, but in a vicinity of portion 38 of the uterine artery (FIG. 7A). Balloon 102 is inflated via tube 22 (FIG. 7B). Tube 22 is withdrawn, leaving balloon 102 inflated and compressing (squeezing) the portion of uterine artery 28 that supplies the fibroid (FIG. 7C).
  • Reference is now made to FIGS. 8-10, which are schematic illustrations of apparatus 120 for treating uterine fibroids, in accordance with an embodiment of the present invention. Apparatus 120 is generally similar to apparatus 100 described with reference to FIGS. 4-6, except as described hereinbelow.
  • Apparatus 120 comprises a balloon 122 that is disposed at distal tip 36 during initial placement of apparatus 120 (FIG. 8). Balloon 122 is inflated (FIG. 9). Distal tip 36 is separated from balloon 122 by pulling distal tip 36 in a direction 138 away from the balloon (FIG. 10). When distal tip 36 is separated from balloon 122, a valve 126 of the balloon closes, preventing or inhibiting deflation of the balloon.
  • Reference is now made to FIGS. 11A-C, which are schematic illustrations of a procedure for placing balloon 122 within the patient's body, in accordance with an embodiment of the present invention. The procedure is generally similar to that shown and described with reference to FIGS. 7A-C, except as noted. Tube 22 penetrates vaginal tissue 24 until apparatus 120 is outside of uterine artery 28, but in a vicinity of portion 38 of the uterine artery (FIG. 11A). Balloon 122 is inflated via tube 22 (FIG. 11B). Tube 22 is withdrawn, leaving balloon 122 inflated and compressing (squeezing) the portion of uterine artery 28 that supplies the fibroid (FIG. 11C). An extractor 130, coupled to balloon 122, typically resides in part within vagina 26 while balloon 122 is squeezing portion 38 of uterine artery 28. Extractor 130 facilitates extraction of the balloon from the patient when it is determined that occlusion of the uterine artery should terminate.
  • Reference is now made to FIGS. 12A and 12B, which are schematic illustrations of a system 140 comprising a balloon 142 configured to release at least a portion of its contents 144 while in the patient's body, in accordance with an embodiment of the present invention. As appropriate, balloon 142 may comprise any of balloons 40, 102, or 122, described hereinabove, mutatis mutandis, and may be configured for use in place of these balloons.
  • In an embodiment, an orifice 148 of balloon 142 slowly releases contents 144 in order to generate a slow deflation of the balloon, e.g., over at least 30 minutes, such as at least 3 hours or at least 10 hours. The rate of release is typically configured such that a volume of balloon 142 decreases at an average rate of between 1%/hour and 30%/hour (e.g., 1%-5%/hour, 5%-15%/hour, or 15%-30%/hour), calculated over a 30 minute period. By way of illustration and not limitation, this use of system 140 is useful when balloon 142 comprises balloon 102, described hereinabove with reference to FIGS. 4-7. In particular, balloon 142 when it comprises balloon 102 is typically configured to remain in the patient's body chronically or to biodegrade. The releasing of contents 144 causes a desired slow deflation of the balloon at generally the time when occlusion of the uterine artery should terminate. For these purposes, contents 144 typically comprise saline and/or another biocompatible fluid.
  • Alternatively or additionally, contents 144 comprise a pharmaceutical product, such as an anesthetic (e.g., lidocaine), an antibiotic, and/or an anti-inflammatory agent. Release of contents 144 within the patient's body, in this case, does not necessarily cause a substantial reduction in the volume of balloon 142 (but may be configured to do so nevertheless, for example, when balloon 142 comprises balloon 102).
  • It is noted that volume reduction by release of contents 144 through orifice 148 is suitable for any of the balloons described herein.
  • In an embodiment, contents 144 are released passively, due to pressure within balloon 142. Alternatively or additionally, the contents are released actively, e.g., due to a pump. For some applications, the pump comprises an expanding gas generated, for example, by a combination of chemicals or by hydrolysis. The expanding gas expels contents 144 at a desired rate, using techniques that are known in the art.
  • Reference is now made to FIGS. 13A and 13B, which are schematic illustrations of apparatus for deflating a balloon 162, in accordance with an embodiment of the present invention. As appropriate, balloon 162 may comprise any of balloons 40, 102, 122, or 142 described hereinabove, mutatis mutandis, and may be configured for use in place of these balloons.
  • Balloon 162 is typically configured to deflate, without active human intervention, while within the patient. In an embodiment, balloon 162 comprises a deflation element 166 that operates passively. For example, deflation element 166 may be biodegradable (FIG. 13A), and the balloon configured such that degrading of deflation element 166 causes the deflation of the balloon (FIG. 13B). Typically, deflation element 166 is configured to degrade sufficiently to cause the deflation of balloon 162 between about 1 and 36 hours after placement within the patient, e.g., between about 5 and 10 hours thereafter.
  • In an embodiment, deflation element 166 is configured to actively cause the deflation of balloon 162. For example, deflation element 166 may comprise a puncturing element or a heating element, which is actuated at an appropriate time to cause deflation of the balloon by puncturing or heating. The deflation element in this case may operate automatically (i.e., without human intervention), or in response to a command received from a human operator.
  • For some applications, an endpoint indicator is provided, which is configured to generate an endpoint signal indicative of a desired endpoint of the occluding of the uterine artery. Deflation element 166 typically deflates balloon 162 in response to the signal. In an embodiment, the endpoint indicator senses a temperature of fibroid 30, and generates the endpoint signal when the temperature of the fibroid equilibrates to the temperature of surrounding tissue. (In many patients, a fibroid is slightly warmer than surrounding tissue.) Alternatively, the endpoint signal continuously indicates the temperature of the fibroid, and a human interprets the endpoint signal to determine whether the desired endpoint has been reached. In an embodiment, the endpoint indicator comprises a timer, and the endpoint signal corresponds to a desired duration for occlusion of uterine artery 28 (e.g., a duration that is between about 1 and 36 hours, such as about 5-10 hours). In this case, deflation element 166 typically causes the deflation of balloon 162 at the end of this time period, either automatically or in response to a command.
  • In an embodiment, an inflation sensor 170 is configured to generate a signal indicative of a level of inflation of balloon 162. Inflation sensor 170 is typically attached to the balloon (as shown), but may alternatively be disposed remotely from the balloon. An indicator 182 is typically provided to generate an indication to a human of the level of inflation. The indication is typically numerical (as shown), but may alternatively or additionally be, for example, textual or color coded (e.g., red=fully inflated; yellow=partially inflated; and green=approximately deflated). Indicator 182 is typically configured to be disposed outside of the patient's body, e.g., on a wand 180, and to receive the signal wirelessly from the inflation sensor.
  • When inflation sensor 170 indicates that balloon 162 has deflated, the balloon is typically removed or allowed to remain chronically, and the patient examined and discharged from the healthcare facility (e.g., a hospital or doctor's office).
  • In an embodiment, inflation sensor 170 comprises a pressure sensor 172, configured to generate the signal in response to a level of pressure in the balloon. Alternatively, inflation sensor 170 comprises another device configured to detect a property of the balloon indicative of the inflation thereof, such as a strain gauge coupled to the balloon. For some applications, the inflation sensor is configured to generate the signal in response to a characteristic of blood flow in uterine artery 28. For example, the inflation sensor may comprise an ultrasound sensor or a pressure sensor. Restoration of pulsatile flow in uterine artery 28 (following its reduction during uterine artery occlusion) is typically interpreted as indicating that balloon 162 has deflated. If the restoration of pulsatile flow is detected prematurely (e.g., less than a predetermined time, such as 1 hour or 6 hours following initiation of uterine artery occlusion), then the flow restoration is typically interpreted to indicate that the balloon has prematurely deflated or moved out of proper positioning with respect to uterine artery 28. In this case, appropriate steps are taken to re-occlude the uterine artery.
  • Inflation sensor 170 is typically battery operated, but may alternatively receive power via an antenna 174, ultrasound transducer, or other suitable circuitry known in the art.
  • It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims (37)

  1. 1. Apparatus, comprising:
    a tube, configured to be passed into a patient's vagina and to penetrate vaginal tissue until a distal tip of the tube is outside of a uterine artery of the patient, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid; and
    a balloon, configured to be disposed at the distal tip and to be inflated to cause local squeezing of the portion of the uterine artery to an extent sufficient to occlude the uterine artery.
  2. 2. The apparatus according to claim 1, wherein the tube is configured to be passed into the patient's vagina during a medical procedure, and wherein the balloon is configured to be removed from the patient during the same medical procedure.
  3. 3. (canceled)
  4. 4. The apparatus according to claim 1, comprising an endpoint indicator, configured to generate a signal indicative of a desired endpoint of the occluding of the uterine artery.
  5. 5-7. (canceled)
  6. 8. The apparatus according to claim 1, wherein the apparatus is configured such that the tube can be separated from the balloon and removed from the patient while the balloon remains, inflated, within the patient.
  7. 9. The apparatus according to claim 8, wherein the balloon comprises a valve, through which the tube inflates the balloon, and which inhibits deflation of the balloon after separation of the balloon from the tube.
  8. 10. The apparatus according to claim 8, wherein the balloon is configured for deflation within the patient following the squeezing, and to reside chronically within the patient.
  9. 11. The apparatus according to claim 8, wherein the balloon is configured for removal from the patient following the deflation.
  10. 12. The apparatus according to claim 11, comprising an extractor, coupled to the balloon, configured to reside in part within the patient's vagina while the balloon is causing the local squeezing, and configured to facilitate extraction of the balloon from the patient.
  11. 13. The apparatus according to claim 1, comprising a sensor, configured to generate a signal that is indicative of proximity of the distal tip to the uterine artery.
  12. 14. The apparatus according to claim 13, wherein the sensor comprises an acoustic sensor.
  13. 15. The apparatus according to claim 13, wherein the sensor comprises a pressure sensor.
  14. 16. The apparatus according to claim 15, wherein the pressure sensor is configured to operate substantially without transmitting energy towards the uterine artery.
  15. 17. The apparatus according to claim 1, wherein the balloon is shaped to define an orifice that is configured to release contents of the balloon into a body of the patient, when the balloon is within the patient.
  16. 18. The apparatus according to claim 17, comprising saline, configured for placement within the balloon and to be at least a portion of the contents of the balloon released into the body of the patient.
  17. 19. The apparatus according to claim 17, comprising a pharmaceutical product, configured for placement within the balloon and to be at least a portion of the contents of the balloon released into the body of the patient.
  18. 20. The apparatus according to claim 19, wherein the pharmaceutical product comprises an anesthetic.
  19. 21. The apparatus according to claim 19, wherein the pharmaceutical product comprises a pharmaceutical selected from the group consisting of: an anti-inflammatory agent, and an antibiotic.
  20. 22. The apparatus according to claim 17, wherein the balloon and orifice are configured such that the release of the contents occurs over a time period that lasts for at least 30 minutes.
  21. 23. The apparatus according to claim 22, wherein the time period is at least 3 hours, and wherein the balloon and orifice are configured such that the release of the contents occurs over the time period that lasts at least 3 hours.
  22. 24. The apparatus according to claim 17, wherein the balloon and orifice are configured such that the release of the contents reduces a volume of the balloon at an average rate of between 1%/hour and 30%/hour, calculated over a 30 minute period.
  23. 25-27. (canceled)
  24. 28. The apparatus according to claim 1, wherein the balloon is configured to remain within the patient for at least 7 days following termination of the occlusion.
  25. 29. The apparatus according to claim 28, wherein at least a portion of the balloon is biodegradable.
  26. 30. The apparatus according to claim 28, wherein at least a portion of the balloon is not biodegradable.
  27. 31. The apparatus according to claim 1, wherein the balloon is configured to deflate, without active human intervention, while within the patient.
  28. 32. The apparatus according to claim 31, wherein the balloon comprises a biodegradable deflation element, configured such that degrading of the biodegradable deflation element causes the deflation of the balloon.
  29. 33. The apparatus according to claim 31, wherein the balloon is configured to deflate at a time that is at least 1 hour after inflation of the balloon.
  30. 34. The apparatus according to claim 31, comprising:
    an inflation sensor, configured to generate a signal indicative of a level of inflation of the balloon; and
    an indicator, configured to generate an indication to a human of the level of inflation.
  31. 35. The apparatus according to claim 34, wherein the inflation sensor comprises a pressure sensor, configured to generate the signal in response to a level of pressure in the balloon.
  32. 36. The apparatus according to claim 34, wherein the inflation sensor comprises a sensor configured to generate the signal in response to a characteristic of blood flow in the uterine artery.
  33. 37-44. (canceled)
  34. 45. A method, comprising:
    advancing a tool to a site within a patient, outside of a vagina of the patient and outside of a uterine artery of the patient, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid; and
    squeezing the portion of the uterine artery with the tool, to an extent sufficient to occlude the uterine artery.
  35. 46-92. (canceled)
  36. 93. A method, comprising:
    advancing a balloon to a site within a patient, outside of an artery of the patient; and
    squeezing the artery by inflating the balloon to an extent sufficient to occlude the artery.
  37. 94-99. (canceled)
US11591044 2006-07-24 2006-10-31 Fibroid treatment apparatus and method Abandoned US20090093758A1 (en)

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