Use of focused ultrasound for vascular sealing

• US 6,656,136 B1
• Filed: 10/25/2000
• Issued: 12/02/2003
• Est. Priority Date: 10/25/1999
• Status: Active Grant

• Current Assignee: Otsuka Medical Devices Co., Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Therus Corp. (Boston Scientific Corporation)
• Inventors: Zhang, Jimin, Perozek, David M., Weng, Lee
• Primary Examiner(s): Walberg, Teresa
• Assistant Examiner(s): FUQUA, SHAWNTINA T
• Application Number:
  US09/696,076
• Time in Patent Office: 1,133 Days
• Field of Search: 601/2, 600/407, 600/411, 600/427, 600/371, 600/462, 600/463, 600/467
• US Class Current: 601/2
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00504 Tissue welding
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3904 specially adapted for marking specified tissue
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 8/4422 related to hygiene or sterilisation
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: G10K 11/32 characterised by the shape of the source
• CPC Class Codes: G10K 11/346 using phase variation

Abstract

A method and system for locating a vascular opening and therapeutically sealing the wound with high intensity focused ultrasound (HIFU) is disclosed. A control unit (6) coupled to an applicator unit includes a processor (74) that automates the disclosed procedure, controlling various parameters of the diagnostic and therapeutic modes, including the intensity and duration of the ultrasonic energy emitted by the applicator unit. The disclosed method and system is and then discarded, is slipped over the particularly applicable to sealing a puncture made inserting a catheter during an interventional cardiovascular procedure.

Claims

1. A method for sealing a vascular opening in a patient'"'"'s body, comprising:

a) performing at least one catheterization procedure on a patient whereby the opening is created;

b) identifying a treatment zone to which ultrasonic energy should be applied to close the vascular opening;

c) positioning an ultrasonic transducer applicator, comprising at least one ultrasound radiating surface, adjacent the zone determined in step (b);

d) emitting a therapeutic ultrasound beam from the at least one radiating surface onto the treatment zone;

e) administering a sufficient therapeutic ultrasonic energy to the treatment zone to seal the vascular opening created in step (a).

2. The method of claim 1, wherein the ultrasound energy administered is high intensity focused ultrasound (HIFU) energy.

3. The method of claim 2, wherein the treatment zone is located on a femoral, brachial or radial artery.

4. The method of claim 3, wherein the ultrasound energy is transcutaneously applied.

5. The method of claim 4, wherein the ultrasonic applicator at any given time is moveable in a plurality of directions.

6. The method of claim 5, further comprising the step of over-scanning the treatment zone ensuring that the vascular opening is treated and sealed.

7. The method of claim 1 or 6 further comprising the step of applying compressive force to the treatment zone to promote hemostasis of the vascular opening.

8. The method of claim 7, where in the force applied is controllable.

9. The method of claim 7, wherein the force applied is generated in the ultrasound transducer applicator.

10. The method of claim 1 wherein the step (b), further comprises the steps of

(a) generating an imaging ultrasonic beam, said imaging ultrasonic beam being transmitted proximate an expected location for the opening;

(b) receiving a reflection of the imaging ultrasonic beam and in response producing a corresponding output signal; and

(c) processing the output signal to determine a location of the vascular opening and an appropriate treatment zone.

11. The method of claim 10, further comprising the step of providing a visual indication of at least a portion of the vascular opening.

12. The method of claim 10, further comprising the step of providing a visual indication of at least a portion of the treatment zone.

13. The method of claim 11 or 12, wherein the ultrasonic transducer applicator comprises a common array of transducers configured to emit ultrasound energy suitable for both imaging and therapeutic ultrasound applications.

14. The method of claim 13, wherein the visual indication comprises an image.

15. The method of claim 14, further comprising the step of providing a visual indication member that extends from outside the patient into the vascular opening.

16. The method of claim 15, wherein the visual indication comprises en image of the visual indication member inserted into the vessel through the opening.

17. The method of claim 16, further comprising the step of estimating the location of the vessel puncture based on a disposition of a visual indication member in the vessel opening.

18. The method of claim 17, wherein the ultrasound energy administered to the treatment zone is high intensity focused ultrasound (HIFU) energy.

19. The method of claim 18, wherein the treatment zone is located on a femoral, brachial or radial artery.

20. The method of claim 19, wherein tho imaging and therapeutic ultrasound beams are transcutaneously applied.

21. The method of claim 20, wherein the ultrasonic applicator, at any given time, is moveable in a plurality of directions.

22. The method of claim 10, further comprising the step of interrupting the administration of the ultrasonic energy to generate a second imaging ultrasound beam to confirm that the ultrasonic energy is being directed to the treatment zone.

23. The method of claim 21, further comprising the step of interrupting the administration of the ultrasonic energy to generate a second imaging ultrasound beam to confirm that the ultrasonic energy is being directed to the treatment zone.

24. The method of claim 10, further comprising the step of applying a compressive force to the treatment zone to promote hemostasis of the vascular opening.

25. The method of claim 21, further comprising the step of applying a compressive force to the treatment zone to promote hemostasis of the vascular opening.

47. The method of claim 1, 10, 26 or 34 further comprising the step of interposing a sterile barrier between the transducer applicator and the vascular opening.

48. The method of claim 1, 10, 26 or 34 further comprising the step of interposing an acoustic couplant between the transducer applicator and the vascular opening.

26. A method for sealing a vascular opening in a patient'"'"'s body, comprising:

a) identifying a treatment zone to which ultrasonic energy should be applied to close the vascular opening;

b) positioning an ultrasonic transducer applicator, comprising at least one ultrasound radiating surface, adjacent the zone determined in step (a);

c) applying a compressive force to the treatment zone;

d) emitting a therapeutic ultrasound beam from the at least one radiating surface onto the treatment zone; and

e) administering a sufficient therapeutic ultrasonic energy to the treatment zone to seal the vascular opening.

27. The method of claim 26, wherein the ultrasound energy administered is high intensity focused ultrasound (HIFU) energy.

28. The method of claim 27, wherein the treatment zone is located on a femoral, brachial or radial artery.

29. The method of claim 28, wherein the ultrasound energy is transcutaneously applied.

30. The method of claim 29, wherein the ultrasonic applicator at any given time is moveable in a plurality of directions.

31. The method of claim 30, wherein the force is controllable.

32. The method of claim 30, wherein the force is generated in the ultrasonic transducer applicator.

33. The method of claim 30, further comprising the step of over-scanning the treatment zone ensuring that the vascular opening is treated and sealed.

34. The method of claim 26, wherein the step (a), further comprises the steps of:

(a) generating an imaging ultrasonic beam, said imaging ultrasonic beam being transmitted proximate an expected location for the opening;

(b) receiving a reflection of the imaging ultrasonic beam and in response producing a corresponding output signal; and

(c) processing the output signal to determine a location of the vascular opening and an appropriate treatment zone.

35. The method of claim 34, further comprising the step of providing a visual image of at least a portion of the vascular opening.

36. The method of claim 34, further comprising the step of providing a visual image of at least a portion of the treatment zone.

37. The method of claim 35 or 36, wherein the ultrasonic transducer applicator comprises a common array of transducers configured to emit ultrasound energy suitable for both imaging and therapeutic ultrasound applications.

38. The method of claim 37, further comprising the step of providing a visual indication member that extends from outside the patient into the vascular opening.

39. The method of claim 38, wherein the visual indication comprises an image of the visual indication member inserted into the vessel through the opening.

40. The method of claim 39, further comprising the step of estimating the location of the vessel puncture based on a disposition of a visual indication member in the vessel opening.

41. The method of claim 40, wherein the ultrasound energy administered to the treatment zone is high intensity focused ultrasound (HIFU) energy.

42. The method of claim 31, wherein the treatment zone is located on a femoral, brachial or radial artery.

43. The method of claim 42, wherein the imaging and therapeutic ultrasound beams are transcutaneously applied.

44. The method of claim 32, wherein the ultrasonic applicator, at any given time, is moveable in a plurality of directions.

45. The method of claim 32, further comprising the step of interrupting the administration of the ultrasonic energy to generate a second imaging ultrasound beam to confirm that the ultrasonic energy is being directed to the treatment zone.

46. The method of claim 45, further comprising the step of interrupting the administration of the ultrasonic energy to generate a second imaging ultrasound beam to confirm that the ultrasonic energy is being directed to the treatment zone.