Hollow medical wires and methods of constructing same

• US 6,375,628 B1
• Filed: 02/16/2000
• Issued: 04/23/2002
• Est. Priority Date: 03/06/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic PercuSurge, Inc. (Medtronic Plc)
• Inventors: Muni, Ketan P., Bagaoisan, Celso J., Zadno-Azizi, Gholam-Reza
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/505,380
• Time in Patent Office: 797 Days
• Field of Search: 600/433, 600/434, 600/435, 600/585, 604/96.01, 604/101, 604/103, 604/103.09, 604/264, 604/523, 604/524, 604/525, 604/530, 604/531
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

The present invention provides an apparatus for performing angioplasty or vascular intervention procedures. The apparatus of the present invention comprises a catheter apparatus comprised of a superelastic hollow guidewire, a balloon member and a flexible tip. The superelastic hollow guidewire of the invention is preferably a hypotube of nitinol alloy. The use of nitinol alloy as hollow guidewire provides a catheter apparatus having high flexibility and torqueability as well as small cross sectional diameter.

Claims

1. A hollow medical guidewire, comprising:

an elongate hollow body having distal and proximal sections, said body being at least partially constructed from a transformational, non-linear superelastic nickel titanium alloy material, wherein at least said distal section has recoverable strain and exhibits an unloading plateau stress of not less than about 170 MPa;

wherein said distal section is provided with openings to allow fluids to escape.

2. The medical guidewire of claim 1, wherein said distal section receives during construction heat treatments in the range of about 300°

C. to about 600°

C. for a period of time ranging from about 10 seconds to about 60 minutes.

3. The medical guidewire of claim 1, wherein at least said distal section exhibits an unloading plateau stress of between about 200 and 320 MPa.

4. A medical catheter comprising an elongate hollow body at least partially constructed from a transformational non-linear superelastic nickel titanium alloy material and having at least one opening at the distal end to allow the escape of fluids, said alloy material exhibiting a substantially constant stress upon unloading of between about 170 MPa and 400 MPa.

5. The catheter of claim 4 further comprising an occlusion device and an inflation lumen for said device positioned within said catheter.

6. The catheter of claim 4 wherein said opening comprises a check valve.

7. The catheter of claim 6, wherein the check valve includes an elastomeric membrane.

8. The catheter of claim 4, wherein said alloy material exhibits a substantially constant stress upon unloading of about 320 MPa or less.

9. The catheter of claim 8, wherein said alloy material exhibits a substantially constant stress upon unloading of about 200 MPa or less.

10. An irrigation catheter, comprising:

an elongate hollow body having distal and proximal sections, said body being at least partially constructed from a transformational, non-linear, superelastic nickel titanium alloy material, wherein at least said distal section has recoverable strain and exhibits an unloading plateau stress of not less than about 170 MPa;

a lumen formed in said body extending from the proximal section to the distal section for communicating fluids from said proximal section of said body to said distal section of said body; and

one or more perforations in the distal section of the body to allow the escape of fluids.

11. The irrigation catheter of claim 10, wherein said nickel content is between about 50.0 and 51.5% atomic weight.

12. The irrigation catheter of claim 11, wherein said nickel content is about 50.8% atomic weight.

13. The irrigation catheter of claim 10, wherein said alloy material in at least said distal section has recoverable strain up to about 8%.

14. The irrigation catheter of claim 10, wherein at least said distal section receives heat treatments of about 300°

C.-600°

C. for about 10 seconds to 60 minutes.

15. The irrigation catheter of claim 10, wherein said alloy material in at least said distal section exhibits an unloading plateau stress of between about 170 and 400 MPa.

16. The irrigation catheter of claim 15, wherein said alloy material in at least said distal section exhibits an unloading plateau stress of between about 200 and 320 MPa.

17. The irrigation catheter of claim 10, wherein said alloy material in at least said distal section exhibits a loading plateau stress of up to about 500 MPa.

18. The irrigation catheter of claim 10, further comprising a coil member in fluid communication with the lumen in the distal section of the body.

19. The irrigation catheter of claim 18, wherein the coil member includes gaps between turns of the coil member to provide a passageway to deliver fluids through the coil member.

20. The irrigation catheter of claim 10, wherein the outer diameter of the body is less than out 0.38″

.

21. An irrigation catheter, comprising:

an elongate hollow body having a proximal end and a distal end and a lumen extending therethrough, said body being constructed at least partially from a transformational, non-linear, superelastic nickel-titanium alloy material which exhibits a substantially constant stress upon unloading of not less than about 170 MPa; and

a coil member extending from the distal end of the body, the coil member being in fluid communication with the lumen of the body and having turns which provide a passageway for fluids to pass therethrough.

22. The irrigation catheter of claim 21, further comprising an occlusion device mounted on said distal section of said body.

23. The irrigation catheter of claim 22, wherein the occlusion device is a balloon.

24. The irrigation catheter of claim 22, further comprising at least one perforation proximal to the occlusion device.

25. The irrigation catheter of claim 21, further comprising at least one perforation near the distal end of the body.

26. The irrigation catheter of claim 21, wherein said alloy material has a nickel content in the range of about 50.0%-51.5% atomic weight.

27. The irrigation catheter of claim 21, wherein said alloy material exhibits a substantially constant stress upon unloading of between about 200 MPa and 320 MPa.

28. An irrigation catheter, comprising:

a hollow elongate tubular body having a proximal end and a distal end and a lumen extending therethrough, the body being constructed at least partially from a transformation nonlinear superelastic nickel titanium alloy material, said alloy material exhibiting a substantially constant stress upon unloading of between about 170 MPa and 400 MPa;

an occlusion device on the distal end of the elongate body;

at least one perforation in the body near the distal end; and

a valve member attached over the at least one perforation to control fluid flow through the perforation.

29. The irrigation catheter of claim 28, wherein the occlusion device is a balloon in fluid communication with the lumen of the body.

30. The irrigation catheter of claim 28, wherein the at least one perforation is proximal to the occlusion device.

31. The irrigation catheter of claim 28, wherein a threshold fluid pressure within the lumen activates the valve member.

32. The irrigation catheter of claim 31, wherein the valve member is an elastomeric membrane.

33. The irrigation catheter of claim 28, wherein the valve member is provided inside the lumen of the elongate body.

34. The irrigation catheter of claim 28, further comprising a coil member extending from the distal end of the body and in fluid communication therewith.