Apparatus and method incorporating an ultrasound transducer onto a delivery member

• US 6,599,288 B2
• Filed: 05/16/2001
• Issued: 07/29/2003
• Est. Priority Date: 05/16/2000
• Status: Expired due to Term

• Current Assignee: Atrionix, Inc. (Johnson & Johnson)
• Original Assignee: Atrionix, Inc. (Johnson & Johnson)
• Inventors: Schaer, Alan K., Peacock, James C. III, Suorsa, Veijo, Maguire, Mark A.
• Primary Examiner(s): Peffley, Michael
• Application Number:
  US09/859,083
• Publication Number:
  US 20020022833A1
• Time in Patent Office: 804 Days
• Field of Search: 606/27, 606/28, 606/41, 607/96, 601/2, 601/3, 600/439, 600/459, 600/462, 600/466
• US Class Current: 606/27
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/22027 Features of transducers
• 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 2017/320088 with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 8/4245 involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient

Abstract

A medical device assembly and method provides an ultrasound transducer mounted onto a catheter shaft. The ultrasound transducer is mounted such that there is a radial separation between the transducer and the underlying catheter shaft. The transducer is mounted on support structures which do not bridge the gap between the transducer and delivery member. The location of the support structures provides for an “airbacked” transducer that is very efficient and prevents heat build-up in the materials in contact therewith.

Claims

1. An ultrasound ablation apparatus comprising:

an elongate catheter body having proximal and distal end portions, an outer wall and an outer diameter;

a cylindrical ultrasound transducer coaxially disposed over said catheter body, said ultrasound transducer having proximal and distal end portions, an inner wall and an inner diameter which is greater than the outer diameter of said catheter body, such that an air gap is provided in a radial separation between the inner wall of said ultrasound transducer and said catheter body; and

a support structure for suspending said ultrasound transducer in a substantially fixed coaxial position relative to said catheter body, wherein said support structure contacts the outer wall of said catheter body at locations proximal and distal to the proximal and distal end portions of said ultrasound transducer, respectively, and wherein said support structure holds said ultrasound transducer without contacting the inner wall of said ultrasound transducer, thereby maintaining said radial separation while reducing acoustic damping caused by said support structure.

2. The ultrasound ablation apparatus of claim 1, wherein said ultrasound transducer is shaped to ablate a circumferential region of tissue.

3. The ultrasound ablation apparatus of claim 1, wherein said ultrasound transducer comprises at least one transmissive panel.

4. The ultrasound ablation apparatus of claim 1, wherein at least a substantial portion of said radial separation is sealed by said support structure to prevent external fluids from entering said radial separation.

5. The ultrasound ablation apparatus of claim 4, wherein a gas is sealed within said radial separation.

6. The ultrasound ablation apparatus of claim 4, wherein a liquid is sealed within said radial separation.

7. The ultrasound ablation apparatus of claim 1, further comprising first and second flanges extending axially from the proximal and distal end portions of said ultrasound transducer, respectively, said support structure being coupled to said first and second flanges.

8. The ultrasound ablation apparatus of claim 7, wherein said support structure further comprises first and second elastomeric O-rings disposed on said catheter body such that said first and second O-rings engage said first and second flanges.

9. The ultrasound ablation apparatus of claim 7, wherein said support structure further comprises first and second sleeves disposed on said catheter body and fitted over said first and second flanges, to secure said ultrasound transducer relative to said catheter body.

10. The ultrasound ablation apparatus of claim 7, wherein said support structure further comprises first and second splines disposed on said catheter body such that said first and second splines engage said first and second flanges.

11. The ultrasound ablation apparatus of claim 7, wherein said support structure further comprises first and second annular members disposed along said catheter body such that said first and second annular members engage said first and second flanges.

12. The ultrasound ablation apparatus of claim 1, wherein said support structure further comprises first and second annular members disposed on said catheter body, said first and second annular members frictionally engaging the proximal and distal end portions of said ultrasound transducer.

13. The ultrasound ablation apparatus of claim 1, wherein said support structure further comprises a shrink-wrap cover layer disposed around said ultrasound transducer.

14. The ultrasound ablation apparatus of claim 1, further comprising an expandable member adapted to engage a circumferential region of tissue, said ultrasound transducer being located inside said expandable member and acoustically coupled to said expandable member.

15. The ultrasound ablation apparatus of claim 14, wherein said expandable member is an inflatable balloon.

16. The ultrasound ablation apparatus of claim 14, wherein a cooling chamber is provided between said ultrasound transducer and said expandable member, said cooling chamber being adapted to allow a cooling fluid to flow over said ultrasound transducer.

17. The ultrasound ablation apparatus of claim 16, further comprising a source of pressurized cooling fluid and a cooling fluid lumen in said catheter body, said lumen having a distal port opening into said cooling chamber.

18. The ultrasound ablation apparatus of claim 14, further comprising a thermocouple for monitoring temperature along at least a portion of said circumferential region of tissue engaged by said expandable member.

19. The ultrasound ablation apparatus of claim 1, further comprising at least one electrical lead coupled to said ultrasound transducer.

20. The ultrasound ablation apparatus of claim 1, further comprising fillets located proximal and distal to the proximal and distal end portions of said ultrasound transducer for sealing said radial separation from entry of external fluids and providing a smooth surface for insertion of said ultrasound ablation apparatus into a body structure.

21. The ultrasound ablation apparatus of claim 1 further comprising a guidewire lumen extending through at least a portion of said catheter body for slidably engaging a guidewire.

22. An ultrasound ablation apparatus, comprising:

an elongate catheter body;

a cylindrical ultrasound transducer having first and second ends and inner and outer surfaces, said ultrasound transducer being mounted coaxially on said catheter body such that a radial separation is provided between said ultrasound transducer and said catheter body for mechanically isolating said ultrasound transducer from said catheter body; and

a support structure coupled to said ultrasound transducer and said catheter body to maintain at least a region of said radial separation for reducing acoustic damping caused by said support structure, wherein said support structure further comprises a substantially tubular member disposed over said catheter body, said tubular member having proximal and distal end regions and an intermediate region, said proximal and distal end regions being formed with a larger diameter than said intermediate region, said ultrasound transducer being disposed over said intermediate region such that it is axially contained by said proximal arid distal end regions.

23. An ultrasound ablation apparatus, comprising:

an elongate catheter body;

a cylindrical ultrasound transducer having first and second ends and inner and outer surfaces, said ultrasound transducer being mounted coaxially on said catheter body such that a radial separation is provided between said ultrasound transducer and said catheter body for mechanically isolating said ultrasound transducer from said catheter body; and

a support structure coupled to said ultrasound transducer and said catheter body to maintain at least a region of said radial separation for reducing acoustic damping caused by said support structure, wherein said support structure further comprises a braided metal tubular member disposed around said catheter body such that said radial separation is maintained therebetween, said ultrasound transducer being mounted coaxially over said braided tubular member.

24. An ultrasound ablation apparatus, comprising:

an elongate catheter body;

a cylindrical ultrasound transducer having first and second ends and inner and outer surfaces, said ultrasound transducer being mounted coaxially on said catheter body such that a radial separation is provided between said ultrasound transducer and said catheter body for mechanically isolating said ultrasound transducer from said catheter body; and

a support structure coupled to said ultrasound transducer and said catheter body to maintain at least a region of said radial separation for reducing acoustic damping caused by said support structure, wherein said support structure further comprises two braided metal tubular members disposed around said catheter body with an axial gap between said braided metal tubular members, said first and second ends of said ultrasound transducer being mounted to said braided tubular members thereby bridging said axial gap.

25. An ultrasound ablation apparatus, comprising:

an elongate catheter body;

a cylindrical ultrasound transducer having first and second ends and inner and outer surfaces, said ultrasound transducer being mounted coaxially on said catheter body such that a radial separation is provided between said ultrasound transducer and said catheter body for mechanically isolating said ultrasound transducer from said catheter body; and

a support structure coupled to said ultrasound transducer and said catheter body to maintain at least a region of said radial separation for reducing acoustic damping caused by said support structure, wherein said support structure further comprises two truncated conical members each having a first end with a large diameter and a second end with a small diameter, said conical members being disposed over said catheter body such that said first ends face inward and said second ends face outward, said inner surface of said ultrasound transducer being engaged by said first ends of said conical member.

26. An ultrasound ablation apparatus, comprising:

an elongate catheter body;

a cylindrical ultrasound transducer having first and second ends and inner and outer surfaces, said ultrasound transducer being mounted coaxially on said catheter body such that a radial separation is provided between said ultrasound transducer and said catheter body for mechanically isolating said ultrasound transducer from said catheter body; and

a support structure coupled to said ultrasound transducer and said catheter body to maintain at least a region of said radial separation for reducing acoustic damping caused by said support structure, wherein said support structure comprises an expandable member disposed over said catheter body and having an outer surface, wherein the inner surface of said ultrasound transducer is coaxially engaged by the outer surface of said expandable member.