Apparatus and method incorporating an ultrasound transducer onto a delivery member

• US 6,607,502 B1
• Filed: 11/05/1999
• Issued: 08/19/2003
• Est. Priority Date: 11/25/1998
• Status: Expired due to Term

• Current Assignee: Atrionix, Inc. (Johnson & Johnson)
• Original Assignee: Atrionix, Inc. (Johnson & Johnson)
• Inventors: Peacock, James C. III, Maguire, Mark A.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US09/435,280
• Time in Patent Office: 1,383 Days
• Field of Search: 606/15, 606/32, 606/27, 606/31, 606/40, 606/41, 606/45, 606/46, 606/47, 606/48, 607/96, 607/99, 607/101, 607/102, 607/122, 600/373, 600/374, 600/381, 600/471, 604/101.01, 604/22
• US Class Current: 604/22
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320088 with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: B06B 1/0625 Annular array

Abstract

A medical device assembly and method provides an ultrasound transducer mounted onto a delivery member, such the elongate body of a catheter shaft, without a support structure bridging between a separation area between the transducer and the shaft. Mounting flanges are extend from either end of the transducer and are mounted at first and second locations along the catheter shaft such that the transducer is suspended over the catheter shaft between those mounting locations. The flanges may be connected by an intermediate member, with the transducer supported on either an outer surface or an inner surface of the intermediate member. The intermediate member may also provide a housing with an enclosed space that houses the transducer, wherein the flanges extend from the housing for mounting to the catheter shaft. In an overall tissue coupling system, a cylindrical ultrasound transducer are mounted onto a catheter shaft by use of such mounting flanges extending from the transducer'"'"'s ends and such that the ultrasound transducer is enclosed within a balloon also provided on the catheter. The balloon is ideally adapted to engage a circumferential region of tissue where a pulmonary vein extends from an atrium such that the cylindrical ultrasound transducer is able to couple through the balloon inflation fluid and to the circumferential region of tissue surrounding the balloon for ablation. The transducer is substantially “airbacked” when mounted onto a delivery member according to the present assembly and method.

Claims

1. A tissue ablation system, comprising:

an elongate body with a proximal end portion, and a distal end portion having a longitudinal axis and a radial axis and which is adapted to be positioned within a body space of a patient by manipulating the proximal end portion; and

an ultrasound ablation element suspended on the distal end portion with a radial separation that defines a radial separation area between the ultrasound ablation element and the distal end portion, and without a support structure bridging across the radial separation area between the ultrasound ablation element and the distal end portion.

2. The system of claim 1, wherein a gas is captured within the radial separation area.

3. The system of claim 2, wherein a substantial portion of the radial separation area is sealed to substantially prevent an external fluid from entering the radial separation area.

4. The system of claim 1, wherein said ultrasound ablation element is adapted to ablate a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in a patient.

5. The system of claim 1, wherein the ultrasound ablation element comprises a cylindrical ultrasound transducer having an inner surface forming an inner bore which is positioned over and around the distal end portion, and the radial separation area is located between the inner surface and the distal end portion.

6. The system of claim 1, wherein said ultrasound ablation element comprises a piezoceramic ultrasound transducer.

7. The system of claim 1, wherein said ultrasound ablation element comprises an array of ultrasound transmissive panels.

8. The system of claim 1, further comprising an external cover layer which is disposed around said ultrasound ablation element and distal end portion such that the ultrasound ablation element is positioned between the external cover layer and the distal end portion.

9. The system of claim 8, wherein said external cover layer comprises an adhesive.

10. The system of claim 8, wherein said external cover layer comprises an external cover member with an inner surface which surrounds the ultrasound ablation element and also an adhesive layer between the inner surface and the ultrasound ablation element.

11. The system of claim 8, wherein the external cover layer has a distal end portion which is secured to the distal end portion of the elongate body distally of the ultrasound ablation element, and also has a proximal end portion which is secured to the distal end portion of the elongate body proximally of the ultrasound ablation element.

12. The system of claim 8, wherein said external cover layer comprises a polymer.

13. The system of claim 1, wherein the ultrasound ablation element comprises first and second end portions, first and second mounting flanges extend axially from said first and second end portions, respectively, relative to the longitudinal axis, and the first and second mounting flanges are secured to the distal end portion at first and second locations, respectively, which are outside of the radial separation area.

14. The system of claim 13, further comprising a first end cap secured to the first mounting flange and also to the distal end portion at the first location, and a second end cap secured to the second mounting flange and also to the distal end portion at the second location.

15. The delivery member of claim 14, wherein at least one of said first and second end caps comprises a plastic or an elastomer.

16. The system of claim 13, further comprising a first O-ring mounted radially between the first mounting flange and the distal end portion at the first location, and a second O-ring mounted radially between the second mounting flange and the distal end portion at the second location.

17. The system of claim 13, wherein each of the first and second mounting flanges comprises a first end portion having a recess which engages the ultrasound ablation element and also a second end portion secured to the distal end portion.

18. The system of claim 13, wherein the first and second mounting flanges are connected.

19. The delivery member of claim 1, further comprising a tubular member having first and second end portions and an interior portion therebetween with an interior surface and an exterior surface, wherein the first and second end portions are secured to first and second locations, respectively, and the ultrasound ablation element is secured to the exterior surface of the intermediate portion.

20. The system of claim 1, further comprising an expandable member located along the distal end portion.

21. The system of claim 20, wherein the expandable member comprises an outer wall which is adjustable between a radially collapsed position and a radially expanded position, and the ultrasound ablation element is located radially between the outer wall and the distal end portion and is adapted to ultrasonically couple to tissue radially engaged by the outer wall in the radially expanded position.

22. The system of claim 21, wherein the expandable member is adapted to engage a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in a patient, such that the ultrasound ablation element is adapted to ablate the circumferential region of tissue.

23. The system of claim 1, wherein the ultrasound ablation element is mounted onto the distal end portion at a first location, and further comprising a mounting assembly coupled to the ultrasound ablation element and also to the distal end portion at at least one other location which is outside of the radial separation area, such that the mounting assembly mounts the ultrasound ablation element onto the distal end portion without extending radially across the radial separation area between the distal end portion and the ultrasound ablation element.

24. An ultrasound transducer assembly for use with a delivery member in a tissue ablation system, comprising:

a cylindrical ultrasound transducer having a first end portion, a second end portion, a longitudinal axis extending between the first and second end portions, an outer surface, an inner surface that defines an inner bore extending along the longitudinal axis; and

a mounting assembly coupled to cylindrical ultrasound transducer with a first mounting flange extending longitudinally from the first end portion and a second mounting flange extending longitudinally from the second end portion,

wherein the first and second mounting flanges are adapted to be secured to the delivery member in order to mount the cylindrical ultrasound transducer to the delivery member.

25. The assembly of claim 24, wherein the first and second mounting flanges are connected.

26. The assembly of claim 25, wherein the mounting assembly comprises a mounting member having first and second end portions with an intermediate portion therebetween, an inner surface, and an outer surface, wherein the intermediate portion is coupled to the cylindrical ultrasound transducer and the first and second end portions extend beyond the cylindrical ultrasound transducer relative to the longitudinal axis.

27. The assembly of claim 26, wherein the inner surface along the intermediate portion at least in part surrounds the cylindrical ultrasound transducer.

28. The assembly of claim 26, wherein the cylindrical ultrasound transducer surrounds at least a part of the outer surface along the intermediate portion.

29. The assembly of claim 26, wherein the mounting member along the intermediate portion further comprises an outer layer and an inner layer with a cylindrical space enclosed therebetween, and the cylindrical ultrasound transducer is positioned within the cylindrical space.

30. The assembly of claim 24, wherein the cylindrical ultrasound transducer has an outer diameter, the first and second mounting flanges comprise first and second tubular members, respectively, and each tubular member has a reduced diameter section with an inner diameter which is less than the outer diameter of the cylindrical ultrasound transducer and which is adapted to be secured around the delivery member.

31. A method for manufacturing a tissue ablation device assembly, comprising:

mounting a first mounting flange to a first end portion of a cylindrical ultrasound transducer;

mounting a second mounting flange to a second end portion of an ultrasound transducer;

mounting the first mounting flange to a first location along a distal end portion of a delivery member; and

mounting the second mounting flange to a second location along the distal end portion of the delivery member,

wherein the cylindrical ultrasound transducer is located along the distal end portion of the delivery member between and without extending over the first and second locations.

32. The method of claim 31, further comprising mounting the first mounting flange to the cylindrical ultrasound transducer before mounting the first mounting flange to the delivery member.

33. The method of claim 31, further comprising mounting both of the first and second mounting flanges to the cylindrical ultrasound transducer before mounting the flanges to the delivery member.

34. The method of claim 31, further comprising mounting the first mounting flange to the delivery member before mounting the first mounting flange to the cylindrical ultrasound transducer.

35. The method of claim 31, wherein the first and second mounting flanges are connected by an intermediate member, and further comprising mounting the mounting flanges to the cylindrical ultrasound transducer by mounting the intermediate member to the cylindrical ultrasound transducer.

36. A method for manufacturing an ultrasound transducer assembly for use with a delivery member in a tissue ablation system, comprising:

mounting a first mounting flange to a first end portion of a cylindrical ultrasound transducer having a longitudinal axis; and

mounting a second mounting flange to a second end portion of the cylindrical ultrasound transducer,

wherein the first and second mounting flanges extend from the first and second end portions, respectively, of the cylindrical ultrasound transducer relative to the longitudinal axis such that the mounting flanges are adapted to be secured to the delivery member to thereby mount the cylindrical ultrasound transducer to the delivery member.

37. The method of claim 36, further comprising connecting the first and second mounting flanges along the cylindrical ultrasound transducer.

38. The method of claim 36, further comprising mounting the first mounting flange to the ultrasound transducer before mounting the second mounting flange to the ultrasound transducer.

39. The method of claim 36, further comprising mounting the first and second mounting flanges to the ultrasound transducer such that the mounting flanges are connected.

40. The method of claim 39, further comprising mounting the mounting flanges to the cylindrical ultrasound transducer by substantially enclosing the cylindrical ultrasound transducer within a housing and extending the mounting flanges from the housing beyond the first and second end portions.

41. The method of claim 40, further comprising forming the flanges integrally with at least a portion of the housing.

42. The method of claim 36, further comprising forming the cylindrical ultrasound transducer from an array of ultrasound transducer panels.

43. The method of claim 42, farther comprising adapting each of the array of ultrasound transducer panels to be individually actuatable.

44. The method of claim 36, wherein the first mounting flange comprises a tubular member with first and second end portions, and further comprising mounting the first mounting flange onto the cylindrical ultrasound transducer by mounting the first end portion of the tubular member to a substantial portion of a circumference of the first end portion of the cylindrical ultrasound transducer, such that the second end portion of the tubular member extends from the first end portion of the cylindrical ultrasound transducer.