Occlusion device with deployable paddles for detection and occlusion of blood vessels

• US 20040092979A1
• Filed: 11/19/2002
• Published: 05/13/2004
• Est. Priority Date: 03/28/2001
• 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., Altieri, Greig E., Serra, R. J.
• Granted Patent: US 7,354,444 B2
• Time in Patent Office: Days
• US Class Current: 606/158
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/128 for applying or removing clamps or 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 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• 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 temporarily reducing or abolishing blood flow by occluding blood vessels are provided. A blood vessel-occlusion device embodying features of the invention includes a deployable pressure-applying member with a location sensor, and an applicator. The location sensor is configured to detect a blood vessel, which may be occluded by compression from the pressure-applying member. A pressure-applying member may be released from the applicator, with blood-vessel compression maintained after release. The applicator is configured to engage a guide, such as a tenaculum, to aid in the placement and operation of the applicator. A pressure-applying member may also engage the guide. 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 section.

Claims

1. A blood vessel occlusion device, comprising:

a. two pressure-applying members each having a tissue-contacting surface, a proximal portion with a proximal end, and a distal portion having a distal end, said ends being separated by a length, said pressure-applying members having first configurations attached to an applicator, and second configurations released from said applicator, and being configured to compress tissue between said tissue-contacting surfaces in a pressure-applying configuration in either of said first or said second configurations;

b. an applicator comprising a handle portion having a proximal end, a distal end, said ends being separated by a length, a force transduction element configured to transmit force from said proximal end towards said distal end, and an anchor element configured to releasably secure said pressure-applying members to said applicator; and

c. a sensor secured to a distal portion of a pressure-applying member for locating a blood vessel.

2. The blood vessel occlusion device of claim 1, wherein said sensor is selected from the group of sensors consisting of blood flow sensors, sound sensors, ultrasound sensors, pressure sensors, pulsation sensors, stress sensors, strain sensors, chemical sensors, electromagnetic radiation sensors, and combinations thereof.

3. The blood vessel occlusion device of claim 2, wherein said sensor comprises an ultrasound sensor.

4. The blood vessel occlusion device of claim 3, wherein said ultrasound sensor comprises a Doppler ultrasound sensor.

5. The blood vessel occlusion device of claim 4, wherein said Doppler location sensor is configured to sense ultrasound energy having a frequency of between about 5 MHz and about 20 MHz.

6. The blood vessel occlusion device of claim 4, wherein said Doppler ultrasound sensor is configured to sense ultrasound energy having a frequency of between about 6 MHz and about 10 MHz.

7. The blood vessel occlusion device of claim 1, wherein said pressure-applying member length comprises a length of between about 0.5 inch and about 5 inches.

8. The blood vessel occlusion device of claim 1, wherein said pressure-applying member length comprises a length of between about 1 inch and about 2 inches.

9. The blood vessel occlusion device of claim 1, wherein said pressure-applying members each have a width comprising between about 0.5 inch and about 2.5 inches.

10. The blood vessel occlusion device of claim 9, wherein said width comprises a width of between about 0.7 inch and about 1.3 inches.

11. The blood vessel occlusion device of claim 1, wherein a pressure-applying member comprises a loop-shaped tissue-contacting surface.

12. The blood vessel occlusion device of claim 1, wherein a pressure-applying member comprises a flat tissue-contacting surface.

13. The blood vessel occlusion device of claim 1, wherein a pressure-applying member comprises a curved tissue-contacting surface.

14. The blood vessel occlusion device of claim 1, wherein said handle portion length comprises a length of between about 3 inches and about 10 inches.

15. The blood vessel occlusion device of claim 1, wherein said force transduction element comprises a pair of shafts rotatably connected by a pivot.

16. The blood vessel occlusion device of claim 1, wherein said engagement element is configured to engage a tenaculum.

17. The blood vessel occluding device of claim 1, wherein said anchor element is configured to secure a pressure-applying member to a handle distal end in an attached first configuration, and is configured to release said pressure-applying member from said handle distal end in a released second configuration.

18. The blood vessel occlusion device of claim 17, further comprising a locking mechanism having a locked configuration effective to retain said pressure-applying members in a pressure-applying configuration.

19. The blood vessel occlusion device of claim 18, wherein said locking mechanism is configured effective to retain said pressure applying members in a pressure-applying configuration comprising said released second configuration effective to compress tissue after release from said applicator.

20. The blood vessel occlusion device of claim 1, wherein said pressure-applying members are configured to apply a pressure of between about 5 pounds per square inch (psi) of pressure and about 80 psi of pressure to tissue disposed between said pressure-applying members.

21. The blood vessel occlusion device of claim 20, wherein said force applying members are configured to apply a pressure of between about 7 psi and about 10 psi of pressure to tissue disposed between said pressure-applying members.

22. The blood vessel occlusion device of claim 1, comprising a plurality of sensors.

31. A method of occluding a blood vessel of a patient, comprising:

locating a blood vessel with a sensor of a blood vessel occlusion device of claim 1 having a handle and pressure-applying members; and

compressing a portion of said blood vessel with said pressure-applying members of said blood vessel occlusion device of claim 1.

32. The method of claim 31, further comprising guiding said blood vessel occlusion device with a guide.

33. The method of claim 32, wherein said guide comprises a tenaculum.

34. The method of claim 31, wherein said blood vessel is a uterine artery.

35. The method of claim 31, further comprising releasing said pressure-applying members from said handle.

36. The method of claim 31, wherein said sensor comprises a Doppler ultrasound sensor.

37. The method of claim 36, wherein locating with said Doppler ultrasound blood flow sensor comprises locating a blood vessel with ultrasound having a frequency of between about 5 MHz and about 20 MHz.

38. The method of claim 31, further comprising detecting a change in blood flow in said blood vessel.

39. The method of claim 31, further comprising detecting a reduction in blood flow in said blood vessel.

40. The method of claim 38, wherein said blood vessel is a uterine artery.

41. The method of claim 31, further comprising releasing compression of said blood vessel, wherein said blood vessel remains occluded for only a limited time.

42. The method of claim 41, wherein said limited time comprises a time of between about 0.5 hours and about 24 hours.

43. The method of claim 41, wherein said limited time comprises a time of between about 0.5 hours and about 12 hours.

44. The method of claim 41, wherein said limited time comprises a time of between about 1 hour and about 8 hours.

45. The method of claim 41, wherein said blood vessel is a uterine artery.

46. The method of claim 31, wherein said compressing a portion of said blood vessel comprises applying a pressure of between about 5 psi and about 80 psi.

47. The method of claim 31, wherein said compressing a portion of said blood vessel comprises applying a pressure of between about 7 psi and about 10 psi.

49. The blood vessel occlusion device of claim 1 configured for use in the treatment of post-partum hemorrhage, wherein said pressure-applying member length comprises a length of between about 0.8 inch and about 6 inches.

50. The blood vessel occlusion device of claim 1 configured for use in the treatment of post-partum hemorrhage, wherein said pressure-applying member length comprises a length of between about 2.5 inches and about 4.5 inches.

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

a) a blood vessel occlusion device, comprising;

i. two pressure-applying members each having a tissue-contacting surface, a proximal portion with a proximal end, and a distal portion having a distal end, said ends being separated by a length, said pressure-applying members having first configurations attached to an applicator, and second configurations released from said applicator, and being configured to compress tissue between said tissue-contacting surfaces in a pressure-applying configuration in either of said first or said second configuration;

ii. an applicator comprising a handle portion having a proximal end, a distal end, said ends being separated by a length, a force transduction element configured to transmit force from said proximal end towards said distal end, and an anchor element configured to releasably secure said pressure-applying members to said applicator; and

iii. a sensor secured to a distal portion of a pressure-applying member for locating a blood vessel; and

b. a guide configured to engage said engagement element.

24. The system of claim 23, wherein said guide comprises a tenaculum.

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

26. The system of claim 23, wherein said anchor element is configured to secure a pressure-applying member to a handle distal end in an attached first configuration, and is configured to release said pressure-applying member from said handle distal end in a released second configuration.

27. The system of claim 23, further comprising a locking mechanism having a locked configuration effective to retain said pressure-applying members in a pressure-applying configuration.

28. The system of claim 26, further comprising a locking mechanism having a locked configuration effective to retain said pressure-applying members in a pressure-applying configuration comprising said released second configuration effective to compress tissue after release from said applicator.

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

a) a blood vessel occlusion device, comprising;

i. two pressure-applying members each having a tissue-contacting surface, a proximal portion with a proximal end, and a distal portion having a distal end, said ends being separated by a length, said pressure-applying members having first configurations attached to an applicator, and second configurations released from said applicator, and being configured to compress tissue between said tissue-contacting surfaces in a pressure-applying configuration in either of said first or said second configuration;

ii. an applicator comprising a handle portion having a proximal end, a distal end, said ends being separated by a length, a force transduction element configured to transmit force from said proximal end towards said distal end, and an anchor element configured to releasably secure said pressure-applying members to said applicator; and

iii. a sensor secured to a distal portion of a pressure-applying member for locating a blood vessel; and

b. a sensor controller.

30. The system of claim 29, wherein said sensor comprises a Doppler ultrasound sensor and said sensor controller comprises a Doppler ultrasound sensor controller.

48. A blood vessel occlusion device, comprising:

a. deployable pressure-applying means having a first configuration attached to an applicator means, and a second configuration separated from said applicator means, and being configured to compress tissue in either of said first or said second configurations;

b. applicator means having deployment means configured to releasably secure said pressure-applying means to said applicator means, said applicator means being configured to transmit force to said pressure-applying means effective to compress tissue; and

c. sensor means configured for locating a blood vessel and disposed in or on a said pressure-applying means.