Methods and devices for providing acoustic hemostasis

• US 6,083,159 A
• Filed: 06/04/1999
• Issued: 07/04/2000
• Est. Priority Date: 05/22/1995
• Status: Expired due to Fees

• Current Assignee: THS International, Inc. (Takai Hospital Supply Co., Ltd.)
• Original Assignee: THS International, Inc. (Takai Hospital Supply Co., Ltd.)
• Inventors: DeMarta, Stan, Law, Wing K., Crum, Larry, Driscoll, Edward C. Jr.
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US09/325,885
• Time in Patent Office: 396 Days
• Field of Search: 601/2-4, 600/371, 600/411, 600/427, 600/439, 600/447, 600/454, 600/455
• US Class Current: 600/371
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 5/416 the spleen
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• 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 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4405 Device being mounted on a trolley
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/467 characterised by special input means
• CPC Class Codes: A61B 8/483 involving the acquisition of a 3D volume of data
• CPC Class Codes: A61B 8/485 involving measuring strain or elastic properties
• CPC Class Codes: A61N 2007/0065 Concave transducers
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

Methods and apparatus for the remote coagulation of blood using high-intensity focused ultrasound (HIFU) are provided. A remote hemostasis method comprises identifying a site of internal bleeding and focusing therapeutic ultrasound energy on the site, the energy being focused through an intervening tissue. An apparatus for producing remote hemostasis comprises a focused therapeutic ultrasound radiating surface and a sensor for identifying a site of internal bleeding, with a registration means coupled to the radiating surface and the sensor to bring a focal target and the bleeding site into alignment. The sensor generally comprises a Doppler imaging display. Hemostasis enhancing agents may be introduced to the site for actuation by the ultrasound energy.

Claims

1. A method for producing remote hemostasis within a patient body, the method comprising:

identifying a site at which it is desired to promote hemostasis;

emitting therapeutic ultrasound energy from an ultrasound radiating surface; and

focusing the emitted therapeutic ultrasound energy to coagulate blood adjacent to the site.

2. A method as claimed in claim 1, wherein the identifying step comprises Doppler imaging a section of the patient body using a pulsed ultrasound transducer.

3. A method as claimed in claim 2, wherein the imaging step comprises colorflow imaging.

4. A method as claimed in claim 1, wherein the identifying step comprises locally displacing tissue, monitoring the propagation of tissue displacement, and elasticity imaging a section of the patient body.

5. A method as claimed in claim 1, wherein the identifying step comprises introducing a contrast agent into the bloodstream and angiographically imaging a section of the patient body.

6. A method as claimed in claim 1, wherein the identifying step comprises sensing and isolating a vibrational signature of a vascular breach.

7. A method for producing remote hemostasis within a patient body, the method comprising:

identifying a site at which it is desired to promote hemostasis;

targeting a therapy region adjacent to the site;

generating focused therapeutic ultrasound energy; and

applying the focused therapeutic ultrasound energy from a radiating surface to a target within the therapy region.

8. A method as claimed in claim 7, wherein the targeting step comprises selectively focussing the radiating surface at a target depth.

9. A method as claimed in claim 7, wherein the targeting step comprises translating the radiating surface and an ultrasound imaging transducer array relative to the site, the radiating surface and the imaging array being carried by a housing, and the identifying step comprises imaging the site using the imaging array.

10. A method as claimed in claim 7, wherein the therapy region includes a vessel and blood contained within the vessel.

11. A method as claimed in claim 7, wherein the applying step comprises coagulating blood at the target.

12. A method as claimed in claim 11, wherein the coagulating step comprises heating blood above body temperature to induce thrombosis.

13. A method as claimed in claim 11, wherein the coagulating step comprises mechanically streaming blood and impacting blood against a vessel wall to induce thrombosis.

14. A method as claimed in claim 11, wherein the coagulating step comprises cavitating blood to induce thrombosis.

15. A method as claimed in claim 11, wherein the focusing step further comprises forming a plug within a vessel to occlude the vessel upstream of a vascular breach, a therapy volume extending upstream of the vascular breach.

16. A method as claimed in claim 7, wherein the applying step comprises cauterizing tissue at the target.

17. A method as claimed in claim 16, wherein the therapy region includes an organ fracture.

18. A method as claimed in claim 7, wherein the applying step comprises welding tissues at the target.

19. A method as claimed in claim 7, further comprising mapping coagulated regions.

20. A method for producing remote hemostasis within a patient body, the method comprising:

identifying a site at which it is desired to promote hemostasis;

introducing an ultrasound hemostasis enhancement agent to the site;

generating and emitting therapeutic ultrasound energy from a radiating surface; and

focusing the emitted therapeutic ultrasound energy to activate the hemostasis agent adjacent to the site.

21. A method as claimed in claim 20, wherein the hemostasis agent foams on the application of ultrasound energy.

22. A method as claimed in claim 21, wherein the hemostasis agent comprises a compound including a perfluorocarbon.

23. A method as claimed in claim 20, wherein the hemostasis agent comprises an encapsulated thrombus-producing agent.

24. An apparatus for producing remote hemostasis comprising:

a radiating surface which applies focused therapeutic ultrasound energy to a target volume to produce remote hemostasis, the target volume being separated from the radiating surface;

a sensor which identifies a site at which it is desired to induce hemostasis; and

a registration mechanism coupled to the sensor and the radiating surface to align the target volume and the site.

25. A remote hemostasis apparatus as claimed in claim 24, further comprising a therapy depth varying mechanism coupled to the radiating surface.

26. A remote hemostasis apparatus as claimed in claim 25, wherein the radiating surface comprises a phased array, and wherein the depth varying mechanism comprises a phase controller.

27. A remote hemostasis apparatus as claimed in claim 26, wherein the phased array comprises an annular array.

28. A remote hemostasis apparatus as claimed in claim 24, wherein the sensor comprises a pulsed ultrasound imaging transducer.

29. A remote hemostasis apparatus as claimed in claim 28, further comprising a display coupled to the imaging transducer for providing Doppler imaging of the site.

30. A remote hemostasis apparatus as claimed in claim 28, wherein the sensor further comprises a tissue displacement mechanism, the apparatus further comprising an elasticity imaging display coupled to the sensor.

31. A remote hemostasis apparatus as claimed in claim 24, further comprising a processor coupled to the sensor for isolating a vibrational signal of vascular breaches.

32. A remote hemostasis apparatus as claimed in claim 24, wherein the sensor comprises a display for providing angiographic imaging of the site.

33. A remote hemostasis apparatus as claimed in claim 24, wherein the registration mechanism comprises a mechanical linkage between the radiating surface and the sensor.

34. A remote hemostasis apparatus as claimed in claim 24, wherein the registration mechanism comprises a position indication system coupled to at least one of the radiating surface and the sensor.

35. An apparatus for producing remote hemostasis comprising:

a pulsed ultrasound imaging transducer which images a site at which it is desired to promote hemostasis;

an ultrasound radiating surface which focuses therapeutic energy at a target volume to produce remote hemostasis; and

a display coupled to the imaging transducer and to the radiating surface, the display indicating the relative positions of the target volume and the site at which it is desired to promote hemostasis.

36. A remote hemostasis apparatus as claimed in claim 35, wherein the radiating surface comprises a phased array having a selectable therapy depth between the radiating surface and the target volume, and wherein the display indicates any difference in depth between the selected therapy depth and the site.

37. A remote hemostasis apparatus as claimed in claim 35, further comprising a structure which carries the imaging transducer and the radiating surface, wherein a translation of the structure relative to the site causes the display to indicate repositioning of the site relative to the target volume.

38. A remote hemostasis apparatus as claimed in claim 35, wherein the display comprises a display for providing Doppler colorflow imaging.

39. A remote hemostasis apparatus as claimed in claim 38 further comprising means for providing feedback on regions of coagulated blood.

40. A remote hemostasis apparatus as claimed in claim 35, further comprising a tissue displacement mechanism coupled to the imaging transducer, wherein the display provides an elasticity image.

41. A remote hemostasis apparatus as claimed in claim 40 further comprising means for providing feedback on both regions of coagulated blood and regions of cauterized tissue.

42. A remote hemostasis apparatus as claimed in claim 35, further comprising a coagulation memory coupled to the radiating surface and the display so that the display indicates coagulated regions.