Deployable constrictor for uterine artery occlusion

• US 20040097962A1
• Filed: 11/19/2002
• Published: 05/20/2004
• Est. Priority Date: 11/19/2002
• Status: Active Grant

• Current Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Original Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Inventors: Jones, Michael L., Burbank, Fred H., Olson, Ed, Altieri, Greig E.
• Granted Patent: US 7,172,603 B2
• Time in Patent Office: Days
• US Class Current: 606/119
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• 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 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

Devices, systems and methods for occluding blood vessels include a deployable constrictor having opposed pressure-applying portions, a delivery shaft configured to intravaginally advance the constrictor to the patient'"'"'s cervix, a location sensor configured to detect a blood vessel, a deployment member for deploying the constrictor about the patient'"'"'s cervix, and optionally a guide. The constrictor has a first configuration to receive a cervix and a second configuration to apply pressure to the cervical area to occlude a uterine artery by compression from the pressure-applying members. The pressure-applying members may be released from the cervix after a limited therapeutically effective time. The invention finds use in, for example, treating uterine disorders and conditions which may be treated by occlusion of the uterine arteries, such as uterine fibroids, dysfunctional uterine bleeding, post-partum hemorrhage, and bleeding associated with caesarian sections.

Claims

1. A uterine artery occlusion device, comprising:

a deployable constrictor configured to receive a female patient'"'"'s cervix and having at least one pressure-applying portion having a pressure-applying surface configured to apply pressure to a cervix or a uterus and thereby occlude at least one of the patient'"'"'s uterine arteries;

an elongated delivery shaft configured to intravaginally advance said constrictor to the patient'"'"'s cervix;

a deployment member configured to deploy said constrictor from said delivery shaft and constrict about the cervix or uterus to occlude at least one of the patient'"'"'s uterine arteries; and

at least one locating sensor provided on a distal portion of the device configured to detect a blood vessel.

2. The uterine artery occlusion device of claim 1, wherein said deployable constrictor has an expanded configuration configured to receive a patient'"'"'s cervix, and a contracted configuration configured to apply pressure to a cervix or a uterus after deployment of said deployable constrictor from said delivery shaft.

3. The uterine artery occlusion device of claim 1, wherein said deployable constrictor comprises a wireform fashioned from elongated material.

4. The uterine artery occlusion device of claim 3, wherein said wireform comprises a resilient wireform.

5. The uterine artery occlusion device of claim 1, wherein said locating sensor comprises a Doppler ultrasound sensor.

6. The uterine artery occlusion device of claim 5, wherein said Doppler sensor is configured to sense ultrasound energy having a frequency of between about 5 MHz and about 20 MHz.

7. The uterine artery occlusion device of claim 5, wherein said Doppler ultrasound sensor is configured to sense ultrasound energy having a frequency of between about 6 MHz and about 10 MHz.

8. The uterine artery occlusion device of claim 1, wherein at least one locating sensor is disposed on said delivery shaft.

9. The uterine artery occlusion device of claim 1, wherein at least one locating sensor is disposed on a pressure-applying portion of said constrictor.

10. The uterine artery occlusion device of claim 1, wherein said constrictor comprises at least two opposing pressure-applying portions configured to apply pressure to said cervix or uterus when deployed around the patient'"'"'s cervix.

11. The uterine artery occlusion device of claim 1, wherein said deployable constrictor comprises at least one loop configured to apply pressure to a cervix or a uterus.

12. The uterine artery occlusion device of claim 1, wherein said deployable constrictor comprises a continuous wireform in a double loop configuration configured to apply pressure to a cervix or a uterus.

13. The uterine artery occlusion device of claim 12, wherein said continuous wireform comprises at least two pressure-applying members comprising loop portions having loop lengths oriented substantially along a longitudinal direction and being configured to apply pressure to a cervix or a uterus.

14. The uterine artery occlusion device of claim 11, wherein said wireform comprises a resilient material.

15. The uterine artery occlusion device of claim 14, wherein said at least one loop configured to apply pressure to a cervix or a uterus has a loop length of between about 0.5 inch and about 2 inch.

16. The uterine artery occlusion device of claim 15, wherein said loop length comprises a length of between about 0.75 inch and about 1.5 inch.

17. The uterine artery occlusion device of claim 1, wherein said sensor has a sensing direction that is substantially parallel to said longitudinal direction.

18. The uterine artery occlusion device of claim 1, wherein said delivery shaft comprises a lumen configured to allow passage of a guide therethrough.

19. The uterine artery occlusion device of claim 18, wherein said guide comprises a tenaculum.

20. The uterine artery occlusion device of claim 1, wherein said constrictor is configured to apply a pressure of between about 3 pound per square inch (psi) and about 200 psi to said cervix or uterus.

21. The uterine artery occlusion device of claim 20, wherein said constrictor is configured to apply a pressure of between about 5 psi and about 80 psi to said cervix or uterus.

22. The uterine artery occlusion device of claim 21, wherein said constrictor is configured to apply a pressure of between about 7 psi and about 10 psi to said cervix or uterus.

23. A system for occluding a blood vessel for use by an operator, comprising:

a blood vessel occlusion device, comprising;

a deployable constrictor having at least one pair of opposed pressure-applying members having a first configuration to receive a female patient'"'"'s cervix and a second configuration to apply pressure to the patient'"'"'s cervix or uterus to occlude at least one of the patient'"'"'s uterine arteries;

a delivery shaft configured to intravaginally advance said deployable constrictor in a first configuration to receive at least in the patient'"'"'s cervix, said delivery shaft having a longitudinal axis defining a longitudinal direction;

a deployment member configured to deploy the deployable constrictor from the delivery shaft effective that said deployable constrictor assumes a second configuration about at least part of the patient'"'"'s cervix and to thereby at least partially occlude a uterine artery;

a sensor configured to detect a blood vessel and disposed on at least one of said delivery shaft and said deployable constrictor; and

a sensor controller operatively connected to said sensor and comprising a source of power.

24. The system of claim 23, wherein said constrictor comprises at least two pressure-applying members.

25. The system of claim 23, wherein said sensor comprises a Doppler ultrasound sensor.

26. The system of claim 23, wherein said sensor controller is configured to provide an audible signal.

27. The system of claim 23, wherein said constrictor comprises at least one loop configured to apply pressure to a cervix or uterus.

28. A system for occluding a blood vessel, comprising:

a blood vessel occlusion device, comprising;

a deployable constrictor having at least one pair of opposed pressure-applying members having a first configuration to receive a female patient'"'"'s cervix and a second configuration to apply pressure to the patient'"'"'s cervix or uterus to occlude at least one of the patient'"'"'s uterine arteries;

a delivery shaft configured to intravaginally advance said deployable constrictor in a first configuration to receive at least in the patient'"'"'s cervix, said delivery shaft having a longitudinal axis defining a longitudinal direction;

a deployment member configured to deploy the deployable constrictor from the delivery shaft effective that said deployable constrictor assumes a second configuration about at least part of the patient'"'"'s cervix and to thereby at least partially occlude a uterine artery;

a sensor configured to detect a blood vessel and disposed on at least one of said delivery shaft and said deployable constrictor; and

a guide configured to engage a cervix.

29. The system of claim 28, wherein said constrictor comprises at least two pressure-applying members.

30. The system of claim 28, wherein said guide comprises a tenaculum.

31. The system of claim 28, wherein said sensor comprises a Doppler ultrasound sensor.

32. The system of claim 28, wherein said constrictor comprises a loop of resilient material and configured to apply pressure to a cervix and uterus.

33. The system of claim 29, wherein said at least two pressure-applying members comprise loops of resilient material configured to compress a cervix or uterus.

34. A method of occluding a uterine artery, comprising:

engaging a cervix with a delivery shaft of a uterine artery occlusion device, said delivery shaft carrying a deployable constrictor having at least one pair of opposed pressure-applying members and having a first configuration to receive a female patient'"'"'s cervix and a second configuration to apply pressure to the patient'"'"'s cervix or uterus to occlude at least one of the patient'"'"'s uterine arteries;

detecting a uterine artery with a sensor disposed on at least one of said delivery shaft and said deployable constrictor; and

deploying said deployable constrictor with a deployment member effective to place said deployable constrictor about said cervix in said second configuration effective to apply pressure to said cervix or uterus and to occlude a uterine artery.

35. The method of claim 34, further comprising detecting a change in blood flow through said uterine artery with said sensor.

36. The method of claim 34, further comprising engaging said cervix with a guide.

37. The method of claim 36, wherein said guide comprises a tenaculum.

38. The method of claim 34, wherein said sensor comprises a Doppler ultrasound blood flow sensor.

39. The method of claim 34, wherein said deployable constrictor occludes said uterine artery for only a limited time.

40. The method of claim 39, wherein said limited time comprises a time of between about 0.5 hours and about 24 hours.

41. The method of claim 40, wherein said limited time comprises a time of between about 1 hour and about 9 hours.

42. The method of claim 35, wherein said pressure comprises a pressure of between about 3 psi and about 200 psi.

43. A uterine artery occlusion device, comprising:

a deployable constrictor means configured to apply pressure to a patient'"'"'s cervix or a uterus and thereby occlude at least one of the patient'"'"'s uterine arteries;

a delivery means configured to intravaginally advance said constrictor means to the patient'"'"'s cervix;

a deployment means configured to deploy said constrictor means from said delivery shaft and to place said constrictor means about the cervix or uterus effective to occlude at least one of the patient'"'"'s uterine arteries; and

at least one locating sensor means configured to detect a blood vessel.