Disposable Acoustic Coupling Medium Container

• US 20110040190A1
• Filed: 08/17/2010
• Published: 02/17/2011
• Est. Priority Date: 08/17/2009
• Status: Active Grant

• Current Assignee: HistoSonics, Inc, Board of Regents of the University of Michigan (University of Michigan)
• Original Assignee: HistoSonics, Inc
• Inventors: Roberts, William W., Davison, Thomas W., Jahnke, Russell C., Teofilovic, Dejan, Cain, Charles A., Bertolina, James A.
• Granted Patent: US 9,061,131 B2
• Time in Patent Office: Days
• US Class Current: 600/459
• CPC Class Codes: A61B 17/2251 characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
• CPC Class Codes: A61B 17/2256 with means for locating or checking the concrement, e.g. X-ray apparatus, imaging means A61B17/2255 takes precedence
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/2253 using a coupling gel or liquid
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2090/378 using ultrasound
• 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 8/4272 involving the acoustic interface between the transducer and the tissue
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61N 2007/0039 using microbubbles
• CPC Class Codes: A61N 2007/0043 intra-cavitary
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A medical imaging and therapy device is provided that may include any of a number of features. One feature of the device is that it can acoustically couple an ultrasound therapy transducer to a patient. In some embodiments, the medical imaging and therapy device is configured to conform to the anatomy of a patient'"'"'s perineal area to acoustically couple an ultrasound therapy transducer to the patient for treatment of BPH. The medical imaging and therapy device can be used in therapeutic applications such as Histotripsy, Lithotripsy, and HIFU, for example. Methods associated with use of the medical imaging and therapy device are also covered.

Claims

1. A method of treating a prostate of a patient, comprising:

imaging the prostate with an ultrasound probe;

placing an acoustic medium container over a perineum of the patient; and

applying ultrasonic therapy through the acoustic medium container to cause mechanical fractionation of a target portion of the prostate.

2. The method of claim 1 further comprising inserting the ultrasound probe into the patient'"'"'s rectum to image the prostate.

3. The method of claim 2 further comprising inserting the ultrasound probe into a rectal sheath to provide a liquid seal barrier between the ultrasound probe and the patient'"'"'s rectum.

4. The method of claim 1 further comprising at least partially filling the acoustic medium container with an acoustic coupling medium.

5. The method of claim 1 further comprising securing the acoustic medium container to the patient with an adhesive.

6. The method of claim 1 further comprising securing the acoustic medium container to the patient with a strap.

7. The method of claim 1 wherein the applying step further comprises applying ultrasonic therapy with an ultrasonic therapy transducer coupled to the acoustic medium container.

8. The method of claim 7 further comprising moving the ultrasonic therapy transducer with respect to the patient during the applying ultrasonic energy step.

9. The method of claim 1 further comprising forming a liquid seal against the patient'"'"'s skin with the acoustic medium container.

10. The method of claim 1 further comprising filling the acoustic medium container with an acoustic coupling medium that directly contacts the patient'"'"'s skin.

11. The method of claim 1 further comprising filling the acoustic medium container with an acoustic coupling medium that does not directly contact the patient'"'"'s skin.

12. The method of claim 1 wherein the placing step comprises placing a wearable garment over the perineum of the patient.

13. The method of claim 12 further comprising forming a liquid seal between the wearable garment and the patient.

14. The method of claim 13 further comprising forming a liquid seal between the wearable garment and the patient near the patient'"'"'s waist and near the patient'"'"'s legs.

15. The method of claim 13 further comprising forming a liquid seal between the wearable garment and the patient around the patient'"'"'s perineum.

16. The method of claim 12 wherein the wearable garment comprises a pliable portion around the perineum of the patient.

17. The method of claim 1 further comprising expelling a volume of the acoustic coupling medium into a remote reservoir from the acoustic medium container when the acoustic medium container is compressed, and infusing a volume of the acoustic coupling medium into the acoustic medium container from the remote reservoir when the acoustic medium container is expanded.

18. The method of claim 1 wherein the applying ultrasonic therapy step comprises applying histotripsy.

19. The method of claim 1 wherein the applying ultrasonic therapy step comprises forming cavitation bubbles in the target portion of the prostate.

20. The method of claim 1 wherein the applying ultrasonic therapy step comprises applying acoustic pulses that operate at a frequency between approximately 50 KHz and 5 MHz, having a pulse intensity with a peak negative pressure of approximately 8-25 MPa, a peak positive pressure of more than 10 MPa, a pulse length shorter than 50 cycles, a duty cycle between approximately 0.1% and 5%, and a pulse repetition frequency of less than 5 KHz.

21. An ultrasound therapy device, comprising:

a frame configured to conform to and provide a liquid seal against a patient'"'"'s skin;

a reservoir portion configured to hold an acoustic coupling medium in direct contact with the patient'"'"'s skin; and

an ultrasound transducer in acoustic communication with the acoustic coupling medium, wherein movement of the ultrasound transducer relative to the frame maintains acoustic communication between the ultrasound transducer and the acoustic coupling medium.

22. The ultrasound therapy device of claim 21 further comprising a rectal imaging probe configured to image the patient'"'"'s prostate.

23. The ultrasound therapy device of claim 22 wherein the reservoir portion comprises a sheath configured to receive the rectal imaging probe.

24. The ultrasound therapy device of claim 21 wherein the frame is sized and shaped to conform to a male patient'"'"'s anatomy surrounding the perineum.

25. The ultrasound therapy device of claim 24 wherein the reservoir portion is pliable.

26. The ultrasound therapy device of claim 25 wherein the ultrasound transducer is coupled to the reservoir portion and configured to direct ultrasonic therapy through the perineum to the patient'"'"'s prostate.

27. The ultrasound therapy device of claim 24 further comprising a sling configured to hold the patient'"'"'s scrotum away from the perineum.

28. The ultrasound therapy device of claim 21 wherein the reservoir portion is open so as to expose the acoustic coupling medium to air.

29. The ultrasound therapy device of claim 21 wherein the ultrasound transducer is submerged in the acoustic coupling medium.

30. The ultrasound therapy device of claim 21 wherein the reservoir portion is sealed to contain the acoustic coupling medium against the patient'"'"'s skin.

31. The ultrasound therapy device of claim 21 wherein the acoustic coupling medium comprises a degassed water.

32. The ultrasound therapy device of claim 21 wherein the frame is secured to the patient with an adhesive.

33. The ultrasound therapy device of claim 21 wherein the frame is secured to the patient with a strap.

34. The ultrasound therapy device of claim 21 wherein the frame comprises a wearable garment.

35. The ultrasound therapy device of claim 34 wherein the wearable garment provides a liquid seal against the patient'"'"'s skin near the patient'"'"'s waist and near the patient'"'"'s legs.

36. The ultrasound therapy device of claim 34 wherein the wearable garment provides a liquid seal against the patient'"'"'s skin around the patient'"'"'s perineum.

37. The ultrasound therapy device of claim 21 further comprising a remote reservoir configured to receive the acoustic coupling medium from the reservoir portion when the reservoir portion is compressed and to deliver the acoustic coupling medium to the reservoir portion when the reservoir portion is expanded.

38. The ultrasound therapy device of claim 21 wherein the ultrasonic transducer is configured to deliver a histotripsy pulse to the patient'"'"'s prostate.

39. The ultrasound therapy device of claim 21 wherein the ultrasonic transducer is configured to form cavitation bubbles in the patient'"'"'s prostate.

40. The ultrasound therapy device of claim 21 wherein the ultrasonic transducer is configured to deliver acoustic pulses that operate at a frequency between approximately 50 KHz and 5 MHz, having a pulse intensity with a peak negative pressure of approximately 8-25 MPa, a peak positive pressure of more than 10 MPa, a pulse length shorter than 50 cycles, a duty cycle between approximately 0.1% and 5%, and a pulse repetition frequency of less than 5 KHz.

41. An ultrasound coupling container, comprising:

a frame configured to provide a liquid seal against a patient'"'"'s skin, the frame including first and second portions sized and configured to conform to each side of the patient'"'"'s groin; and

a reservoir portion coupled to the frame and configured to allow positioning and movement of an ultrasound transducer over the patient'"'"'s perineum and prostate.

42. The ultrasound coupling container of claim 41 further comprising a rectal sheath coupled to the reservoir portion.

43. The ultrasound coupling container of claim 41 further comprising a receptacle coupled to the reservoir portion, the receptacle configured to receive the ultrasound transducer.

44. The ultrasound coupling container of claim 41 wherein the reservoir portion is pliable.

45. The ultrasound coupling container of claim 41 wherein the frame comprises a third portion connecting the first and second portions, the third portion configured to conform to the patient'"'"'s skin below the rectum.

46. The ultrasound coupling container of claim 41 further comprising a sling configured to hold the patient'"'"'s scrotum away from the perineum.

47. The ultrasound coupling container of claim 41 wherein the frame is coupled to a wearable garment that is configured to be worn by the patient.