Ultrasonic ablation catheter device having multiple ultrasound transmission members

• US 5,368,557 A
• Filed: 05/05/1993
• Issued: 11/29/1994
• Est. Priority Date: 01/11/1991
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Baxter International Inc.
• Inventors: Nita, Henry, Mills, Timothy C.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US08/061,872
• Time in Patent Office: 573 Days
• Field of Search: 128/24 AA, 128/898, 604/21, 604/22, 604/49, 604/52, 606/159, 606/167, 606/169-171, 601/2
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22041 outside the catheter
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2017/320088 with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters

Abstract

An ultrasound catheter device for transmitting ultrasound into a mammalian body comprising an elongate catheter body having at least one lumen extending longitudinally therethrough. Also extending longitudinally through the lumen are at least two ultrasound transmission members, each of which have a proximal end coupleable to an external ultrasound source and a distal end which terminates near the distal end of the catheter.

Claims

1. An ultrasound catheter device for transmitting ultrasound into a mammalian body, said device comprising:

a) an elongate flexible catheter body having a proximal end, a distal end, and at least one lumen extending longitudinally therethrough;

b) at least two ultrasound transmission members extending longitudinally through said at least one lumen, each of said ultrasound transmission members having a proximal end coupled to an external ultrasound source and a distal end which terminates near the distal end of said catheter;

c) said at least two ultrasound transmission members being configured and constructed to simultaneously transmit ultrasound energy to the distal end of said catheter body; and

d) a distal head member attached to the distal end of said catheter body and coupled to the distal ends of said at least two ultrasound transmission members such that said distal head member will vibrate in accordance with ultrasound being simultaneously transmitted through said at least two ultrasound transmission members.

2. The device of claim 1 wherein said distal head member comprises a plug member inserted into the distal end of said catheter body.

3. The device of claim 2 wherein said distal head member further comprises at least one fluid passage aperture extending longitudinally through said distal head member to permit fluid to flow out of the lumen of said catheter body through said distal head member.

4. The device of claim 1 wherein said distal head member further comprises a guidewire passage aperture extending longitudinally through said distal head member to permit passage of a guidewire therethrough.

5. The device of claim 4 further comprising:

a sidewall guidewire passage aperture formed in the sidewall of said catheter body; and

a tubular guidewire lumen member extending between said sidewall guidewire passage aperture formed in the sidewall of said catheter body and said guidewire passage aperture formed in said distal head;

said sidewall guidewire passage aperture, said tubular guidewire lumen and said distal head guidewire passage aperture thereby combining to form a guidewire passageway through which a guidewire may be passed.

6. The device of claim 1 wherein said at least two ultrasound transmission members comprise first, second and third ultrasound transmission members.

7. The device of claim 1 wherein said ultrasound transmission members are formed of superelastic metal alloy.

8. The device of claim 7 wherein said superelastic metal alloy is NiTi.

9. The device of claim 1 further comprising:

a guidewire passage lumen having a proximal end and a distal end, said guidewire passage lumen extending through at least a portion of said catheter body to permit a guidewire to be passed therethrough.

10. The device of claim 1 wherein said at least two ultrasound transmission members are combined at their proximal ends to form a substantially unitary proximal end portion to facilitate coupling or attachment of said proximal end portion to an ultrasound energy source.

11. The device of claim 10 wherein said at least two ultrasound transmission members are fused at their proximal ends to form said substantially unitary proximal end portion.

12. The device of claim 10 wherein the proximal ends of said at least two ultrasound transmission members are surrounded by a sleeve member to form said substantially unitary proximal end portion.

13. The device of claim 10 wherein the proximal ends of said at least two ultrasound transmission members are entertwined to form said substantially unitary proximal end portion.

14. The device of claim 7 wherein said superelastic metal alloy is selected from the group of metal alloys consisting of:

metal alloys formed by the combination of at least two metal elements, said metal elements being combined in relative amounts which result in said metal alloy having an ultimate tinsel strength at 20°

C. of approximately 1150 Mpa and a super elastic temperature range of approximately 20°

-80°

C.

15. The device of claim 14 wherein said relative amounts of said metal elements are further such that said alloy exhibits an unloading plateau stress at 20°

C. of approximately 135 Mpa.

16. The device of claim 14 wherein said relative amounts of said metal elements are further such that said alloy exhibits a permanent set at 20°

C. after 8 percent strain of approximately 0.2 percent.

17. The device of claim 14 wherein said relative amounts of said metal elements are further such that said alloy exhibits an elongation at failure of approximately 10.0 percent.

18. The device of claim 14 wherein said relative amounts of said metal elements are further such that said alloy exhibits a melting point of approximately 1350°

C.

19. The device of claim 14 wherein said relative amounts of said metal elements are further such that said alloy has a density of approximately 6.5 g/cm.

20. The device of claim 1 wherein sufficient space exists within said at least one lumen to permit a liquid to flow through said at least one lumen and around said at least two ultrasound transmission members to effect temperature control of said ultrasound transmission members;

and wherein said device further comprises;

e) a liquid inlet opening formed into said at least one lumen near the proximal end of said catheter body; and

f) at least one liquid outlet opening formed into said at least one lumen near the distal end of said catheter body;

g) a temperature control liquid being thereby infusable into said inlet opening, through said lumen and out of said outlet opening(s) to effect temperature control of said at least one ultrasound transmission member during operation of said device.

21. An ultrasound catheter device for transmitting ultrasound into a mammalian body, said device comprising:

a) an elongate flexible catheter body having a proximal end, a distal end, and at least one lumen extending longitudinally therethrough;

b) at least two ultrasound transmission members extending longitudinally through said at least one lumen, each of said ultrasound transmission members having a proximal end coupled to an external ultrasound source and a distal end which terminates near the distal end of said catheter; and

c) said at least two ultrasound transmission members being configured and constructed to simultaneously transmit ultrasound energy to the distal end of said catheter body;

d) wherein said at least two ultrasound transmission members are combined at their proximal ends to form a substantially unitary proximal end portion to facilitate coupling or attachment of said proximal end portion to an ultrasound energy source.

22. The device of claim 21 wherein said at least two ultrasound transmission members are fused at their proximal ends to form said substantially unitary proximal end portion.

23. The device of claim 21 wherein the proximal ends of said at least two ultrasound transmission members are surrounded by a sleeve member to form said substantially unitary proximal end portion.

24. The device of claim 21 wherein the proximal ends of said at least two ultrasound transmission members are entertwined to form said substantially unitary proximal end portion.