Ultra-sound catheter for removing obstructions from tubular anatomical structures such as blood vessels

• US 5,267,954 A
• Filed: 05/05/1992
• Issued: 12/07/1993
• 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
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/878,795
• Time in Patent Office: 581 Days
• Field of Search: 128/24 AA, 604/21, 604/22, 606/159, 606/169-171
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/22038 with a guide wire
• 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: A61B 2018/00029 open
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61M 2025/0183 : Rapid exchange or monorail catheters
• CPC Class Codes: A61M 3/0279 : Cannula; Nozzles; Tips; their connection means

Abstract

An ultrasound catheter for removing obstructions from tubular anatomic structures such as blood vessels, said catheter comprising an elongate flexible catheter body having an ultrasound transmission member or wire extending longitudinally therethrough. A distal head is formed on the distal end of the ultrasound transmission member or wire and is affixed to the catheter body. The ultrasound transmission member or wire may be formed of any material capable of transmitting ultrasonic energy including various superelastic metal alloys such as nickel titanium metal alloys. The distal portion of the ultrasound transmission member or wire may be of reduced diameter to provide enhanced flexibility and/or amplification of the ultrasonic energy through the distal portion of the ultrasound transmission member or wire. A coating or jacket may be disposed on all or portion(s) of the ultrasound transmission member or wire to reduce friction between the ultrasound transmission member or wire and surrounding structures.

Claims

1. An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:

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

an ultrasound transmission member extending longitudinally through said lumen of said catheter body, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body; and

a distal head positioned on the distal end of said ultrasound member, said distal head being affixed to said catheter body.

2. The device of claim 1 wherein said distal head comprises an adhesive which secures said distal head to the distal end of said catheter body.

3. The device of claim 1 wherein said distal head comprises a frictional connector which secures said distal head to the distal end of said catheter.

4. The device of claim 3 wherein said distal head comprises spiral threads to frictionally retain said distal head in the distal end of said catheter body.

5. The device of claim 3 wherein said distal head comprises lugs to retain said distal head in the distal end of said catheter body.

6. The device of claim 3 wherein said distal head comprises detents to retain said distal head in the distal end of said catheter body.

7. The of claim 1 wherein said distal head is formed of metal.

8. The device of claim 1 wherein said distal head is formed of plastic.

9. The device of claim 8 wherein said distal head further comprises at least one radiodense marker material affixed to said distal head to improve the visibility of said distal head by radiographic means.

10. The device of claim 1 wherein said distal head comprises a bulbous member formed on the distal end of said ultrasound transmission member.

11. The device of claim 1 wherein said ultrasound transmission member is formed of a metal alloy.

12. The device of claim 11 wherein said metal alloy is a superelastic metal alloy.

13. The device of claim 12 wherein said superelastic metal alloy comprises a shape memory alloy which exhibits superelastic properties when in said martensitic state.

14. The ultrasound catheter of claim 1 wherein said ultrasound transmission member is formed of a nickel-titanium alloy.

15. The ultrasound catheter of claim 14 wherein said nickel titanium alloy has a nickel content of approximately 55.8 weight percent nickel.

16. The ultrasound catheter of claim 1 further comprising a guidewire passage aperture formed longitudinally through said distal head to permit passage of a guidewire therethrough.

17. An over-the-wire embodiment of ultrasound catheter of claim 16 wherein said guidewire passage aperture is communicative with said lumen of said catheter body such that a guidewire may concomitantly pass a) through said lumen of said catheter body and b) through said guidewire passage aperture.

18. The ultrasound catheter of claim 16 wherein said guidewire passage aperture is fluidly communicative with a lumen of said catheter through which fluid may be infused thereby rendering said guidewire passage aperture additionally operable as a distal end aperture through which fluid infused through said lumen may exit the distal end of said catheter.

19. The ultrasound catheter of claim 1 wherein said distal head is fully positioned within and affixed to the distal end of the lumen of said catheter body.

20. The device of claim 1 wherein said distal head has a diameter no greater than the outer diameter of said catheter body.

21. The device of claim 1 wherein at least a portion of said distal head has a diameter greater than the outer diameter of said catheter body adjacent said distal head.

22. The ultrasound catheter of claim 21 wherein said distal head has a frontal surface which is flush with the distal end of said catheter body.

23. The device of claim 1, wherein said distal head is formed of ceramic material.

24. The ultrasound catheter of claim 11 wherein said distal head comprises:

a bulbous distal tip portion which has a diameter approximately equal to the outer diameter of said catheter body and which extends beyond the distal end of said catheter body; and

a proximal portion having a diameter smaller than the diameter of said distal portion, said proximal portion being inserted into the distal end of said catheter body and non-movably affixed to said catheter body.

25. The ultrasound catheter of claim 1 further comprising at least one fluid outlet port located near the distal end of said catheter body, said fluid outlet port being fluidly communicative with said lumen such that fluid injected into the proximal end of said lumen may pass longitudinally through said lumen and out of said at least one fluid outlet port.

26. The ultrasound catheter of claim 1 further comprising at least one distal end fluid outlet port in the distal end of said catheter body, said distal end fluid outlet port being fluidly communicative with said catheter lumen such that fluid injected into the proximal end of said catheter lumen may pass longitudinally through said lumen and out of said distal end aperture.

27. The ultrasound catheter of claim 26 wherein said at least one distal end aperture comprises a hollow bore extending through said distal head such that fluid may flow outwardly through said distal head.

28. The device of claim 1, wherein said distal head is formed of rubber material.

29. The ultrasound catheter of claim 1 wherein said "at least one lumen" comprises a single lumen which permits concommitant passage therethrough of said ultrasound transmission member and said guidewire.

30. The device of claim 1 wherein said "at least one lumen" comprises:

a first lumen wherein said ultrasound transmission resides; and

a second lumen through which said guidewire may be passed.

31. The ultrasound catheter of claim 1 further comprising:

a proximal end connector assembly mounted on the proximal end of said catheter body, said proximal end connector assembly comprising;

an elongate rigid body mounted on the proximal end of said catheter body and having a hollow bore extending longitudinally therethrough, said hollow bore being communicative with a lumen of said catheter body;

said ultrasound transmission member extending proximally from said catheter body through at least a portion of the hollow bore of said rigid body;

a sonic connector apparatus on the proximal end of said proximal end connector assembly for connection of said ultrasound transmission member to a separate ultrasound emitting device such that ultrasonic energy may be transmitted through said ultrasound transmission member to said distal head.

32. The ultrasound catheter of claim 31 further comprising at least one fluid inlet aperture for infusing fluid through the bore of said proximal connector apparatus and through a lumen of said catheter body.

33. The ultrasound catheter of claim 31 further comprising:

a guidewire passage sidearm formed on said proximal connector assembly, said guidewire passage sidearm having a hollow bore extending therethrough and communicating with the longitudinal bore of said proximal connector assembly.

34. The ultrasound catheter of claim 33 further comprising a guidewire diverter tube positioned within the longitudinal bore of said proximal connector assembly and within the hollow bore of said guidewire passage sidearm, said guidewire diverter tube comprising:

a first diverter tube portion positioned within the longitudinal bore of said proximal connector apparatus distal to said guidewire passage sidearm;

a second diverter tube portion positioned within the hollow bore of said guidewire passage sidearm; and

an obtuse bend formed between said first and second diverter tube portions such that a guidewire advanced in a proximal direction through said first portion will impinge adjacent said bend so as to be diverted into said second portion of said diverter tube and out of said guidewire passage sidearm.

35. The device of claim 1 wherein said distal head is integral to said catheter body.

36. The device of claim 1 wherein said distal head is separate from said catheter body.

37. The device of claim 1, wherein the ultrasound transmission member comprises a tapered region near its distal end.

38. The device of claim 37, wherein the ultrasound transmission member comprises a proximal portion and a distal portion separated by the tapered region.

39. The device of claim 38, wherein the proximal portion has a larger diameter than the distal portion.

40. The device of claim 1, wherein the ultrasound transmission member comprises a metal wire having a friction-reducing coating formed thereon.

41. The device of claim 40 wherein said coating comprises a polymeric material.

42. The device of claim 41 wherein said coating comprises polytetrafluoroethylene.

43. The device of claim 41 wherein said coating comprises polyethylene.

44. The device of claim 40 wherein said coating comprises a tubular jacket surrounding at least a portion of said ultrasound transmission member.

45. The device of claim 40 wherein said coating extends over the entire length of said ultrasound transmission member.

46. The device of claim 40 wherein said coating covers less than the entire longitudinal length of said ultrasound transmission member.

47. The device of claim 40 wherein said coating covers discrete regions of said ultrasound transmission member.

48. An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:

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

an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;

a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising;

(i.) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;

(ii.) a proximal member positionable on said ultrasound transmission member and having a threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component;

(iii.) a compressable gripping ferrule positionable between said frontal member and said proximal member such that said gripping ferrule will become inwardly compressed against said ultrasound transmission member when said frontal member component and said proximal member are connected to one another by rotatable threaded connection.

49. The ultrasonic catheter of claim 48 wherein said proximal member is further affixed to said ultrasound transmission member to accomplish additional crimp connection of said sonic connector assembly to said ultrasound transmission member.

50. The ultrasonic catheter of claim 48 wherein said proximal member comprises a series of threads to receive a correspondingly threaded bore of the horn of a separate ultrasound transducer, thereby establishing a releasable screw connection between said ultrasonic catheter and said separate transducer horn.

51. The ultrasonic catheter of claim 48 wherein said sonic connector assembly is positioned on the extreme proximal end of said ultrasound transmission member with the proximal end of said ultrasound transmission member being coterminous with the proximal-most extend of said proximal member of said sonic connector assembly.