Ultrasonic ablation device adapted for guidewire passage

• US 5,342,292 A
• Filed: 05/24/1993
• Issued: 08/30/1994
• Est. Priority Date: 11/04/1991
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Baxter International Inc.
• Inventors: Nita, Henry, Pflueger, Russell
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US08/067,246
• Time in Patent Office: 463 Days
• Field of Search: 128/24 AA, 128/657, 604/22, 604/49, 604/52, 604/53, 606/159, 606/169, 606/171
• 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 2017/22038 with a guide wire
• 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 2210/0019 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: A61M 2025/0183 Rapid exchange or monorail catheters

Abstract

An ultrasonic ablation device for effecting ultrasonic ablation of intravascular obstructions such as plaque or thrombi. The ultrasonic ablation device has a) an elongate catheter body, b) a wave guide or ultrasound transmission wire extending through the elongate catheter body, and c) a distal head or probe member positioned at the distal end of the catheter body. A guidewire lumen or passageway extends longitudinally through the catheter body and a guidewire aperture or passageway extends through the distal head or probe such that a guidewire may be passed through the distal head or probe and through the catheter body. Also disclosed is an improved distal head or probe which may be incorporated in any elongate ultrasonic ablation device, the improvement comprising the formation of a concavity or indentation in the distal or frontal face of the distal head or probe to improve the cavitation created thereby.

Claims

1. An ultrasonic device for removing obstructions from blood vessels, said device comprising:

a guidewire;

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

an ultrasound transmission member extending longitudinally through the luemn of the flexible catheter, said ultrasonic transmission member having a distal end and a proximal end;

a distal head formed on the distal end of said ultrasound transmission member and extending at least partially beyond the distal end of the catheter; and

a guidewire passage aperture extending through said distal head in axial alignment with the lumen of said catheter, wherein said guidewire may be passed through said aperture and thrugh the lumen of said catheter such that said guidewire is spaced apart from said ultrasound transmission member within the lumen.

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

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

4. The device of claim 3 wherein said metal alloy is a superelastic metal alloy.

5. The device of claim 4 wherein said superelastic metal alloy comprises a shape memory alloy capable of existing in a martensitic state and an austenitic state and which exhibits superelastic properties when in its martensitic state.

6. The device of claim 1 wherein said ultrasound transmission member is formed of nickel-titanium alloy having a nickel content of approximately 50.8 atomic percent nickel.

7. The device of claim 1 further comprising at least one coolant inlet port located near the proximal end of the catheter and at least one coolant outlet port located near the distal end of said catheter to allow a flow of coolant liquid through the lumen of the catheter in which said ultrasound transmission member is positioned.

8. The device of claim 1 further comprising a proximal connection apparatus positioned on the proximal end of said catheter, said proximal connection apparatus comprising:

a rigid body member having a hollow inner chamber extending longitudinally therethrough, said rigid body having a proximal end and a distal end;

the distal end of said rigid body being connected to the proximal end of said catheter such that the catheter lumen through which said ultrasound transmission member extends in fluid contact with the hollow inner chamber of said proximal connection apparatus;

said ultrasound transmission member extending through said hollow inner chamber of said proximal connector apparatus;

a sonic connector positioned on the proximal terminus of said ultrasound transmission member and connected to the proximal end of said ultrasound transmission member to permit operative connection of said ultrasound transmission member to a separate ultrasonic transducer.

9. The device of claim 8 wherein said proximal connection apparatus further comprises:

a fluid infusion aperture formed in said rigid body to permit infusion of fluid into the inner chamber of said proximal connection apparatus and through the lumen of said catheter.

10. The device of claim 9 further comprising a tubular fluid infusion sidearm having a hollow lumen in alignment with said fluid infusion aperture.

11. The device of claim 8 wherein said connection apparatus further comprises:

a guidewire exit aperture formed in said rigid body to permit passage of said guidewire out of the hollow inner chamber of said proximal connection apparatus.

12. The device of claim 11 further comprising:

a tubular guidewire exit sidearm having a hollow lumen in alignment with said guidewire exit aperture.

13. The device of claim 11 further comprising:

a guidewire diverter member insertable into said hollow inner chamber adjacent said guidewire exit aperture to divert one end of said guidewire out of said guidewire exit aperture.

14. The device of claim 13 wherein said guidewire diverter member comprises:

a tubular member having a hollow lumen extending therethrough and a beveled tip, said tubular member insertable into said guidewire exit aperture, wherein said diverter member may be rotatably moved between;

(a) a first position wherein the beveled tip of said diverter member is substantially removed from said hollow inner chamber; and

a second position wherein the beveled tip of said diverter member extends at least partially into said hollow inner chamber such that said guidewire being advanced in a proximal direction through said inner chamber will be received into the lumen of said diverter member and thereby diverted out of said guidewire exit aperture through which said diverter member is inserted.

15. The device of claim 13 wherein said guidewire diverter member comprises an obturator member mounted on said rigid body and extendable into the hollow inner chamber of said proximal connection apparatus, at a location adjacent said guidewire exit aperture, to divert said guidewire out of said guidewire exit aperture.

16. The device of claim 8 further comprising:

an elongate tube member positioned around said ultrasound transmission member within the hollow inner chamber of said proximal connection apparatus to limit the side-to-side movement of said ultrasound transmission member.

17. The device of claim 1 wherein said distal head has a distal surface and wherein at least one concavity is formed in said distal surface of said distal head.

18. The device of claim 17 wherein said concavity comprises a conical depression formed in the distal surface of said distal head.

19. The device of claim 17 wherein said concavity comprises a frusto-conical depression formed in said distal surface of said distal head.

20. The device of claim 17 wherein said concavity comprises a rounded depression formed in the distal surface of said distal head.

21. The device of claim 17 wherein said guidewire passage aperture is formed at the deepest point of said concavity in the distal surface of said distal head.

22. The device of claim 1 further comprising:

a guidewire exit aperture formed at the proximal end of said flexible catheter to permit passage of said guidewire out of said flexible catheter; and

means positioned on said guidewire exit aperture for locking said guidewire in a substantially fixed position relative to said catheter.

23. The device of claim 22 wherein said locking means comprises:

a tubular body insertable into said hollow inner chamber adjacent said guidewire exit aperture to divert one end of said guidewire out of said guidewire exit aperture, said tubular body having a hollow lumen extending therethrough;

gripping apparatus comprising a hollow portion through which said tubular body passes, said hollow portion having a slot extending therethrough, and said gripping apparatus having ribs provided on an outer surface; and

a U-shaped slidable locking member having inner surfaces and a central tongue insertable into said slot, said tongue provided with an aperture at a central portion thereat, and a plurality of sets of grooves formed on the inner surfaces of the slidable locking member;

said aperture of said tongue aligned with said hollow lumen of said tubular body for said guidewire to extend therethrough, said ribs adapted to be seated within at least one set of said plurality of sets of grooves.

24. The device of claim 1 wherein said distal head comprises a transmission member receiving bore and wherein said distal head is mounted on said transmission member by press-fitting said transmission member into said bore without application of substantial heat to said ultrasound transmission member.

25. The device of claim 24 further comprising a heat shrink fit of said ultrasound transmission member within the bore of said distal head.

26. The device of claim 1 wherein said guidewire passage aperture comprises a chamfered enlargement at a proximal end of said guidewire passage aperture.

27. An ultrasonic device for removing obstructions from blood vessels, said device comprising:

a guidewire;

an elongate flexible catheter having a proximal end, a distal end, and at least two lumens extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through a first lumen of the flexible catheter, said ultrasonic transmission member having a distal end and a proximal end;

a distal head formed on the distal end of said ultrasound transmission member and extending at least partially beyond the distal end of the catheter;

a guidewire passage aperture extending through said distal head in axial alignment with the first lumen of said catheter, wherein said guidewire may be passed through said aperture and through a second lumen of said catheter, the first and second lumens spaced apart from each other and preventing contact of said guidewire with said ultrasound transmission member.

28. The device of claim 27, further comprising:

a guidewire exit aperture formed at the proximal end of said flexible catheter to permit passage of said guidewire out of said flexible catheter; and

a guidewire diverter member insertable into said flexible catheter adjacent said guidewire exit aperture to divert one end of said guidewire out of said guidewire exit aperture.

29. The device of claim 28 wherein said guidewire diverter member comprises:

a tubular member having a hollow lumen extending therethrough and a beveled tip, said tubular member insertable into said guidewire exit aperture, wherein said diverter member may be rotatably moved between;

(a) a first position wherein the beveled tip of said diverter member is substantially removed from said flexible catheter; and

(b) a second position wherein the beveled tip of said diverter member extends at least partially into said flexible catheter such that said guidewire being advanced in a proximal direction through the second lumen of said flexible catheter will be received into the hollow lumen of said diverter member and thereby diverted out of said guidewire exit aperture through which said diverter member is inserted.

30. The device of claim 28 wherein said guidewire diverter member comprises an obturator member mounted on said flexible catheter and extendable therein at a location adjacent said guidewire exit aperture, to divert said guidewire out of said guidewire exit aperture.

31. The device of claim 28 further comprising means positioned on said diverter member for locking said guidewire in a substantially fixed position relative to said catheter.

32. The device of claim 31 wherein said diverter member comprises a tubular body having a hollow lumen extending therethrough, and wherein said locking means comprises:

gripping apparatus comprising a hollow portion through which said tubular body passes, said hollow portion having a slot extending therethrough, and said gripping apparatus having ribs provided on an outer surface; and

a U-shaped slidable locking member having inner surfaces and a central tongue insertable into said slot, said tongue provided with an aperture at a central portion thereat, and a plurality of sets of grooves formed on the inner surfaces of the slidable locking member;

said aperture of said tongue aligned with said hollow lumen of said tubular body for said guidewire to extend therethrough, said ribs adapted to be seated within at least one set of said plurality of sets of grooves.

33. The device of claim 28, wherein said distal head has a distal surface with at least one concavity being formed therein.

34. The device of claim 33 wherein the concavity formed in the distal surface of the distal head comprises a rounded depression.

35. The device of claim 33 wherein the concavity formed in the distal surface of the distal head comprises a conical depression.

36. The device of claim 33 wherein the concavity formed in the distal surface of the distal head comprises a frusto-conical depression.

37. An ultrasonic device for removing obstructions from blood vessels, said device comprising:

a guidewire;

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

an ultrasound transmission member extending longitudinally through a lumen of the flexible catheter, said ultrasonic transmission member having a distal end and a proximal end;

a distal head formed on the distal end of said ultrasound transmission member and extending at least partially beyond the distal end of the catheter;

a guidewire passage aperture extending through said distal head in axial alignment with a lumen of said catheter, wherein said guidewire may be passed through said aperture and through a lumen of said catheter;

a guidewire exit aperture formed at the proximal end of said flexible catheter to permit passage of a guidewire out of said flexible catheter;

a guidewire diverter member insertable into said flexible catheter adjacent said guidewire exit aperture to divert one end of said guidewire out of said guidewire exit aperture, said diverter member comprising a tubular body having a hollow lumen extending therethrough; and

means positioned on said guidewire diverter member for locking said guidewire in a substantially fixed position relative to said catheter, said locking means comprising;

gripping apparatus comprising a hollow portion through which said tubular body passes, said hollow portion having a slot extending therethrough, and said gripping apparatus having ribs provided on an outer surface; and

a U-shaped slidable locking member having inner surfaces and a central tongue insertable into said slot, said tongue provided with an aperture at a central portion thereat, and a plurality of sets of grooves formed on the inner surfaces of the slidable locking member;

said aperture of said tongue aligned with said hollow lumen of said tubular body for said guidewire to extend therethrough, said ribs adapted to be seated within at least one set of said plurality of sets of grooves.

38. The device of claim 37 wherein said guidewire diverter member comprises an obturator member mounted on said flexible catheter and extendable therein at a location adjacent said guidewire exit aperture, to divert said guidewire out of said guidewire exit aperture.

39. The device of claim 37 wherein said "at least one lumen" comprises a single lumen wherein said ultrasound transmission member and said flexible guidewire may both reside.

40. The device of claim 37 wherein said "at least one lumen" comprises:

a first lumen wherein said ultrasound transmission member resides;

and a second lumen in said guidewire passage aperture, such that said guidewire may be passed through said aperture and through said second lumen.

41. An ultrasonic device for removing obstructions from blood vessels, said device comprising:

a guidewire;

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

an ultrasound transmission member extending longitudinally through the lumen of the flexible catheter, said ultrasonic transmission member having a distal end and a proximal end;

a distal head formed on the distal end of said ultrasound transmission member and extending at least partially beyond the distal end of the catheter;

a guidewire passage aperture extending through said distal head in axial alignment with the lumen of said catheter, wherein said guidewire may be passed through said aperture and through the lumen of said catheter;

a guidewire exit aperture formed at the proximal end of said flexible catheter to permit passage of said guidewire out of said flexible catheter; and

means positioned on said guidewire exit aperture for locking said guidewire in a substantially fixed position relative to said catheter, wherein said locking means comprises;

a tubular body insertable into said hollow inner chamber adjacent said guidewire exit aperture to divert one end of said guidewire out of said guidewire exit aperture, said tubular body having a hollow lumen extending therethrough;

gripping apparatus comprising a hollow portion through which said tubular body passes, said hollow portion having a slot extending therethrough, and said gripping apparatus having ribs provided on an outer surface; and

a U-shaped slidable locking member having inner surfaces and a central tongue insertable into said slot, said tongue provided with an aperture at a central portion thereat, and a plurality of sets of grooves formed on the inner surfaces of the slidable locking member;

said aperture of said tongue aligned with said hollow lumen of said tubular body for said guidewire to extend therethrough, said ribs adapted to be seated within at least one set of said plurality of sets of grooves.

42. An ultrasonic device for removing obstructions from blood vessels, said device comprising:

a guidewire;

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

an ultrasound transmission member extending longitudinally through a lumen of the flexible catheter, said ultrasonic transmission member having a distal end and a proximal end;

a distal head formed on the distal end of said ultrasound transmission member and extending at least partially beyond the distal end of the catheter;

a guidewire passage aperture extending through said distal head in axial alignment with the first lumen of said catheter, wherein said guidewire may be passed through said aperture and through a second lumen of said catheter;

a guidewire exit aperture formed at the proximal end of said flexible catheter to permit passage of a guidewire out of said flexible catheter; and

a guidewire diverter member insertable into said flexible catheter adjacent said guidewire exit aperture to divert one end of said guidewire out of said guidewire exit aperture, wherein said guidewire diverter member comprises a tubular member having a hollow lumen extending therethrough and a beveled tip, said tubular member insertable into said guidewire exit aperture, wherein said diverter member may be rotatably moved between;

(a) a first position wherein the beveled tip of said diverter member is substantially removed from said flexible catheter; and

(b) a second position wherein the beveled tip of said diverter member extends at least partially into said flexible catheter such that said guidewire being advanced in a proximal direction through a lumen of said flexible catheter will be received into the hollow lumen of said diverter member and thereby diverted out of said guidewire exit aperture through which said diverter member is inserted.

43. An ultrasonic device for removing obstructions from blood vessels, said device comprising:

a guidewire;

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

an ultrasound transmission member extending longitudinally through a lumen of the flexible catheter, said ultrasonic transmission member having a distal end and a proximal end;

a distal head formed on the distal end of said ultrasound transmission member and extending at least partially beyond the distal end of the catheter;

a guidewire passage aperture extending through said distal head in axial alignment with the first lumen of said catheter, wherein said guidewire may be passed through said aperture and through a second lumen of said catheter;

a guidewire exit aperture formed at the proximal end of said flexible catheter to permit passage of a guidewire out of said flexible catheter;

a guidewire diverter member insertable into said flexible catheter adjacent said guidewire exit aperture to divert one end of said guidewire out of said guidewire exit aperture, wherein said guidewire diverter member comprises a tubular member having a hollow lumen extending therethrough and a beveled tip, said tubular member insertable into said guidewire exit aperture, wherein said diverter member comprises a tubular body having a hollow lumen extending therethrough; and

means positioned on said diverter member for locking said guidewire in a substantially fixed position relative to said catheter, wherein said locking means comprises;

gripping apparatus comprising a hollow portion through which said tubular body passes, said hollow portion having a slot extending therethrough, and said gripping apparatus having ribs provided on an outer surface; and

a U-shaped slidable locking member having inner surfaces and a central tongue insertable into said slot, said tongue provided with an aperture at a central portion thereat, and a plurality of sets of grooves formed on the inner surfaces of the slidable locking member;

said aperture of said tongue aligned with said hollow lumen of said tubular body for said guidewire to extend therethrough, said ribs adapted to be seated within at least one set of said plurality of sets of grooves.