Deployable constrictor for uterine artery occlusion

• US 7,172,603 B2
• Filed: 11/19/2002
• Issued: 02/06/2007
• Est. Priority Date: 11/19/2002
• Status: Expired due to Fees

• 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.
• Primary Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US10/300,495
• Publication Number:
  US 20040097962A1
• Time in Patent Office: 1,540 Days
• Field of Search: 606/158, 606/142, 606/151, 606/119
• 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 constrictor is for 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 having an interior configured to receive a female patient'"'"'s uterine cervix and having at least one pressure-applying portion having a pressure-applying surface configured to apply pressure to the patient'"'"'s uterine cervix or a vaginal surface to 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 uterine cervix;

a deployment member configured to deploy said constrictor from said delivery shaft about the patient'"'"'s uterine cervix so that pressure applied by constriction of the pressure applying surface of the constrictor occludes 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 uterine cervix, and a contracted configuration configured to apply pressure to the cervix or a vaginal surface after deployment of said deployable constrictor from said delivery shaft to occlude at least one of the patient'"'"'s uterine arteries.

3. The uterine artery occlusion device of claim 1, wherein said deployable constrictor comprises a wirefom.

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 has at least two opposing pressure-applying portions configured to apply pressure to the patient'"'"'s uterine cervix or vaginal surface to occlude both of the patient'"'"'s uterine arteries when deployed around the patient'"'"'s cervix.

11. The uterine artery occlusion device of claim 1, wherein said deployable constrictor comprises a wireform having at least one loop configured to apply pressure to the patient'"'"'s cervix or a vaginal surface.

12. The uterine artery occlusion device of claim 1, wherein said deployable constrictor comprises a wireform having a double loop configuration configured to apply pressure to the patient'"'"'s cervix or a vaginal surface.

13. The uterine artery occlusion device of claim 12, wherein loops of said wireform have loop lengths oriented substantially along a longitudinal direction.

14. The uterine artery occlusion device of claim 11, wherein said wireform is formed of 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 vaginal surface.

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 vaginal surface.

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 vaginal surface.

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 a female patient'"'"'s uterine artery, comprising:

an occlusion device, comprising;

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

a delivery shaft configured to intravaginally advance said deployable constrictor in the 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 after receiving the female patient'"'"'s cervix and assuming the second configuration to apply pressure about at least part of the patient'"'"'s cervix and to thereby at least partially occlude at least one of the uterine arteries;

a sensor configured to detect at least one uterine artery 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 wireform configured to apply pressure to the female patient'"'"'s cervix or vaginal surface.

33. The system of claim 29, wherein the wireform has at least two pressure-applying members comprising loops of resilient material configured to compress the female patient'"'"'s cervix or vaginal surface.

34. A method of occluding at least one uterine artery of a female patient, comprising:

providing a uterine artery occlusion device having an elongated delivery shaft, a deployable constrictor mounted on the delivery shaft which has at least one pair of opposed pressure-applying members with a first mounted configuration to receive a female patient'"'"'s cervix and a second deployed configuration to apply pressure to the patient'"'"'s cervix or vaginal tissue to occlude at least one of the patient'"'"'s uterine arteries and having a blood flow sensor to detect at least one uterine artery;

locating the deployable constrictor in the first mounted configuration about the female patient'"'"'s cervix;

detecting a uterine artery with the blood flow sensor; and

deploying said deployable constrictor about said cervix in said second configuration to apply pressure to said cervix or vaginal surface 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 receive and apply pressure to a patient'"'"'s cervix or vaginal surface 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 means 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.