FIBROID TREATMENT APPARATUS AND METHOD

• US 20090318950A1
• Filed: 07/18/2007
• Published: 12/24/2009
• Est. Priority Date: 07/24/2006
• Status: Active Grant

• Current Assignee: Fibro Control, Inc.
• Original Assignee: Fibro Control, Inc.
• Inventors: Gross, Yossi
• Granted Patent: US 8,357,176 B2
• Time in Patent Office: Days
• US Class Current: 606/193
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1054 having detachable or disposable balloons
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Apparatus is provided, including a tube (22) that is configured to pass into a patient'"'"'s vagina (26) and to penetrate vaginal tissue (24) until a distal tip (36) of the tube is outside of a uterine artery (28) of the patient, but in a vicinity of a portion (38) of the uterine artery that supplies a uterine fibroid (30). A balloon (40), 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.

Claims

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 at a site 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. The apparatus according to claim 1, wherein the balloon is configured to be disposed at a distance of less than 4 cm from the portion of the uterine artery to cause the local squeezing of the portion of the uterine artery.

4. The apparatus according to claim 1, wherein the tube is configured to reside in part within the patient'"'"'s vagina throughout the time that the balloon is causing the local squeezing, and is configured to facilitate extraction of the balloon from the patient.

5. The apparatus according to claim 4, wherein the tube comprises a flexible tube.

6. The apparatus according to claim 5, further comprising a plug disposed at a proximal end of the tube.

7. The apparatus according to claim 6, further comprising a syringe and a syringe needle, which are configured to pierce the plug and inflate the balloon via the tube, wherein the plug is configured to seal itself subsequent to withdrawal of the syringe.

8. The apparatus according to claim 1, further comprising an introducer configured to be passed into a patient'"'"'s vagina and to penetrate vaginal tissue until a distal tip of the introducer is at the site, wherein the tube is configured to pass through the vaginal tissue, via the introducer, until the distal tip of the tube is at the site.

10. The apparatus according to claim 8, further comprising a pharmaceutical-administration tube configured for placement within the introducer and configured to facilitate administration to the patient of a pharmaceutical product.

13. The apparatus according to claim 8, wherein the introducer comprises a stopper configured to stop the penetration of the vaginal wall by the introducer when the distal tip of the introducer is disposed at the site.

14. The apparatus according to claim 13, wherein the stopper is disposed at an angle of between 45 degrees and 85 degrees from a longitudinal axis of the introducer.

15. The apparatus according to claim 13, wherein the stopper is disposed at an angle of between 75 degrees and 85 degrees from a longitudinal axis of the introducer.

16. The apparatus according to claim 13, wherein the stopper is disposed at a distance of between 1 cm and 2 cm from the distal tip of the introducer.

19. The apparatus according to claim 8, wherein the tube is configured to reside in part within the patient'"'"'s vagina throughout the time that the balloon is causing the local squeezing, and is configured to facilitate extraction of the balloon from the patient.

20. The apparatus according to claim 19, wherein the introducer is configured to be split and to be removed from the patient when the distal tip of the tube is at the site.

28. The apparatus according to claim 1, wherein at least a portion of the balloon allows light to pass therethrough, and wherein the apparatus comprises a scope configured to permit visualization, through the portion of the balloon, of tissue beyond the balloon.

29. The apparatus according to claim 1, further comprising an endpoint indicator, configured to generate a signal indicative of a desired endpoint of the occluding of the uterine artery.

38. The apparatus according to claim 1, further comprising a sensor, configured to generate a signal that is indicative of proximity of the distal tip to the uterine artery.

40. The apparatus according to claim 38, wherein the sensor comprises a pressure sensor.

41. The apparatus according to claim 40, wherein the pressure sensor is configured to operate substantially without transmitting energy towards the uterine artery.

42. 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.

45. The apparatus according to claim 42, further comprising an anesthetic, 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.

47. The apparatus according to claim 42, 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.

53. 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.

54. The apparatus according to claim 53, wherein at least a portion of the balloon is biodegradable.

56. The apparatus according to claim 1, wherein the balloon is configured to deflate, without active human intervention, while within the patient.

3. (canceled)

9. (canceled)

11-12. -12. (canceled)

17-18. -18. (canceled)

21-27. -27. (canceled)

30-37. -37. (canceled)

39. (canceled)

43-44. -44. (canceled)

46. (canceled)

48-52. -52. (canceled)

55. (canceled)

57-69. -69. (canceled)

70. 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.

72. The method according to claim 70, wherein the tool includes a tube and a balloon coupled to the tube, and wherein squeezing the portion of the uterine artery comprises inflating the balloon.

90. The method according to claim 70, wherein the method does not comprise performing lumbar puncture.

91. The method according to claim 70, further comprising identifying attainment of a desired endpoint of the occluding of the uterine artery.

96. The method according to claim 91, further comprising terminating the squeezing in response to the identifying, wherein the method comprises, subsequently to the terminating, maintaining at least a portion of the tool within the patient for at least 7 days.

97. The method according to claim 70, further comprising terminating the squeezing, without active human intervention, while the tool is within the patient.

71. (canceled)

73-89. -89. (canceled)

92-95. -95. (canceled)

98-136. -136. (canceled)

137. A method, comprising:

surgically implanting a balloon within a patient; and

configuring the balloon to deflate, without human intervention, within 36 hours.

138. A method, comprising:

surgically implanting a balloon within a patient, via a vagina of the patient; and

configuring the balloon to deflate without human intervention.

139-141. -141. (canceled)

142. A method, comprising:

implanting a biodegradable balloon within a patient; and

initiating a medical procedure by inflating the balloon.