Method and apparatus for the detection and occlusion of blood vessels

• US 20030120306A1
• Filed: 11/19/2002
• Published: 06/26/2003
• Est. Priority Date: 04/21/2000
• 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., Werneth, Randy, Wong, Yu-Tung, Uyeno, Jill, Serra, R. J.
• Application Number:
  US10/300,115
• Publication Number:
  US 20030120306A1
• Time in Patent Office: Days
• US Class Current: 606/205
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• 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 17/282 Jaws
• 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 17/4241 Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00035 pH
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• 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 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/42 : Details of probe positioning or probe attachment to the patient
• CPC Class Codes: A61B 8/488 : involving Doppler signals
• CPC Class Codes: A61L 24/0031 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 24/0042 : Materials resorbable by the body

Abstract

The invention provides devices, systems and methods for reducing or abolishing blood flow by occluding arteries. A non-invasive blood vessel occlusion device embodying features of the invention includes a pair of pressure-applying members with opposed tissue-contacting surfaces, a supporting shaft configured to adjust the distance between tissue-contacting surfaces, and at least one sensor for locating a blood vessel disposed on at least one pressure-applying member. Blood vessels may be occluded by indirectly compressing the artery by compressing tissue near to an artery. The invention finds use in, for example, treating uterine disorders and conditions which may be treated by occlusion of the uterine arteries. A uterine artery may be accessed via a body cavity, such as a patient'"'"'s vagina, and may be occluded by compressing a portion of the vaginal wall around a portion of a uterine artery.

Claims

1. A non-invasive blood vessel occlusion device, comprising:

a. a pair of pressure-applying members having opposed tissue-contacting surfaces on distal portions thereof;

b. a pair of pivotally-connected supporting shafts extending from said pair of pressure-applying members configured to adjust the distance between the opposed tissue-contacting surfaces of the pressure-applying members; and

c. at least one sensor for locating a blood vessel disposed in or on a pressure-applying member to facilitate location of the blood vessel to be occluded.

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

3. The non-invasive blood vessel occlusion device of claim 2, wherein said sensor comprises a blood flow sensor.

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

5. The non-invasive blood vessel occlusion device of claim 4, wherein said Doppler sensor is configured to sense ultrasound energy having a frequency of between about 5 MHz and about 19 MHz.

6. The non-invasive blood vessel 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.

7. The non-invasive blood vessel occlusion device of claim 6, wherein said Doppler ultrasound sensor is configured to sense ultrasound energy having a frequency of about 8 MHz.

8. The non-invasive blood vessel occlusion device of claim 2, wherein said sensor is an electromagnetic radiation sensor configured to sense electromagnetic radiation having a wavelength of between about 500 nanometers (nm) and about 2000 nm.

9. The non-invasive blood vessel occlusion device of claim 2, wherein said sensor is an electromagnetic radiation sensor configured to sense electromagnetic radiation having a wavelength of between about 700 nm and about 1000 nm.

10. The device of claim 1, wherein at least one sensor has a sensing direction effective that a blood vessel disposed along said sensing direction will likely be detected, and wherein said at least one sensor is disposed on said tissue-contacting surface effective that said sensing direction is perpendicular to said tissue-contacting surface.

11. The device of claim 1, wherein a pressure-applying member has a distal tip and wherein said sensor is spaced between about 0.1 inch and about 1 inch proximal of said distal tip.

12. The device of claim 11, wherein said sensor is disposed at a location between about 0.2 inch and about 0.6 inch proximal of said distal tip.

13. The device of claim 12, wherein said sensor is disposed at a location about 0.4 inch proximal of said distal tip.

14. The device of claim 1, wherein said non-invasive blood vessel occlusion device is configured for intravaginal use.

15. The non-invasive blood vessel occlusion device of claim 11, further comprising a pair of handles with a tip, each of said handles connected to one of said supporting shafts, and wherein said each of said handle tips is separated from said distal tip of said pressure-applying member by a length of between about 0.5 inch and about 16 inches.

16. The non-invasive blood vessel occlusion device of claim 15, wherein said length comprises a length of between about 1 inch and about 12 inches.

17. The non-invasive blood vessel occlusion device of claim 1, further comprising a locking mechanism configured to retain a pressure-applying member in a desired position.

18. The non-invasive blood vessel occlusion device of claim 17, wherein said locking mechanism comprises a releasable mechanism.

19. The non-invasive blood vessel occlusion device of claim 1, wherein said pair of opposed pressure-applying members are movably configured effective to compress tissue disposed between said pressure-applying members upon movement of said pressure-applying members.

20. The non-invasive blood vessel occlusion device of claim 1, wherein said pressure-applying members are configured to apply between about 15 pounds per square inch (psi) of pressure and about 125 psi of pressure to tissue disposed between said pressure-applying members.

21. The non-invasive blood vessel occlusion device of claim 20, wherein said pressure-applying members are configured to apply between about 30 psi of pressure and about 60 psi of pressure to tissue disposed between said pressure-applying members.

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

23. A system comprising:

a non-invasive blood vessel occlusion device comprising a pair of pressure-applying members having opposed tissue-contacting surfaces on distal portions thereof;

a pair of pivotally-connected supporting shafts extending from said pair of pressure-applying members configured to adjust the distance between the opposed tissue-contacting surfaces of the pressure-applying members; and

at least one sensor for locating a blood vessel disposed in or on a pressure-applying member; and

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

24. The system of claim 23, wherein said sensor comprises a Doppler ultrasound sensor and said sensor controller comprises a Doppler ultrasound controller.

25. The system of claim 23, wherein said sensor controller is configured to provide an output detectable by an operator.

26. The system of claim 23, further comprising a device configured for grasping a portion of a patient'"'"'s body.

27. The system of claim 26, wherein said device for grasping a portion of a patient'"'"'s body comprises a device configured for grasping a uterine cervix.

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

non-invasively locating a blood vessel with a sensor; and

non-invasively compressing a portion of said blood vessel by applying pressure to tissue adjacent a blood vessel with a non-invasive blood vessel occlusion device comprising said sensor.

29. The method of claim 28, wherein said sensor comprises a blood flow sensor.

30. The method of claim 29, wherein said blood flow sensor comprises a Doppler ultrasound blood flow sensor.

31. The method of claim 29, further comprising detecting a change in blood flow in said blood vessel.

32. The method of claim 29, wherein said blood vessel comprises a uterine artery and said locating comprises detecting blood flow in a uterine artery.

33. The method of claim 32, wherein compressing comprises applying pressure to a vaginal wall.

34. The method of claim 33, further comprising grasping a uterine cervix.

35. The method of claim 32, wherein said non-invasive blood vessel occlusion device comprises a releasable non-invasive blood vessel occlusion device, and said uterine artery remains occluded for only a limited time.

36. The method of claim 35, wherein said limited time comprises a time of between about 0.2 hours and about 12 hours.

37. The method of claim 35, wherein said limited time comprises a time of between about 0.5 hours and about 4 hours.

38. The method of claim 32, wherein said compressing a portion of said uterine artery comprises applying between about 15 psi of pressure and about 125 psi of pressure to body tissue.

39. The method of claim 32, wherein said compressing a portion of said uterine artery comprises applying between about 30 psi of pressure and about 60 psi of pressure to body tissue.

40. The method of claim 29, wherein said locating comprises detecting blood flow in a uterine artery with a blood flow sensor disposed on a pressure-applying member with a tissue-contacting surface defining a direction opposite said surface, said blood flow sensor being configured to locate a blood vessel occupying a location disposed in a direction substantially opposite said tissue-contacting surface.

41. The method of claim 30, wherein locating with said Doppler ultrasound blood flow sensor comprises locating a uterine artery with ultrasound having a frequency of between about 5 MHz and about 19 MHz.

42. The method of claim 30, wherein locating with said Doppler ultrasound blood flow sensor comprises locating a uterine artery with ultrasound having a frequency of between about 6 MHz and about 10 MHz.

43. The method of claim 30, wherein locating with said Doppler ultrasound blood flow sensor comprises locating a uterine artery with ultrasound having a frequency of about 8 MHz.

44. A non-invasive blood vessel occlusion device, comprising:

a. a pair of pressure-applying members having opposed tissue-contacting surfaces on distal portions thereof;

b. a pair of pivotally-connected supporting shafts extending from said pair of pressure-applying members configured to adjust the distance between the opposed tissue-contacting surfaces of the pressure-applying members; and

c. an ultrasound sensor/transducer for locating a blood vessel disposed in or on a pressure-applying member configured to provide ultrasound signals and to receive ultrasound reflections so as to facilitate location of the blood vessel to be occluded.

45. A non-invasive blood vessel occlusion device, comprising:

a. pressure-applying means for applying pressure to tissue;

b. sensor means for locating a blood vessel to facilitate location of the blood vessel to be occluded; and

c. supporting means for supporting said pressure-applying means and said sensor means.

46. A non-invasive blood vessel occlusion device, comprising:

a. pressure-applying means for applying pressure to tissue;

b. sensor/transducer means for providing signals and for sensing reflected signals for locating a blood vessel to facilitate location of the blood vessel to be occluded; and

c. supporting means for supporting said pressure-applying means and said sensor/transducer means.