Hollow medical wires and methods of constructing same

• US 6,217,567 B1
• Filed: 10/08/1999
• Issued: 04/17/2001
• Est. Priority Date: 03/06/1997
• Status: Expired due to Term

• Current Assignee: Mirage IP LLC (IP Edge LLC)
• Original Assignee: Percusurge Inc. (Medtronic Plc)
• Inventors: Muni, Ketan P., Bagaoisan, Celso J., Zadno-Azizi, Gholam-Reza
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/415,607
• Time in Patent Office: 557 Days
• Field of Search: 604/96.01, 604/101, 604/103, 604/264, 604/523, 604/530, 604/531, 604/524, 604/525, 604/103.09, 600/585
• US Class Current: 604/530
• 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;

an occlusion device mounted on said distal section of said body; and

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.

2. The medical guidewire of claim 1, wherein said nickel content is between about 50.0 and 51.5% atomic weight.

3. The medical guidewire of claim 2, wherein said nickel content is about 50.8% atomic weight.

4. The medical guidewire of claim 1, wherein said alloy material in at least said distal section has recoverable strain up to about 8%.

5. The medical guidewire of claim 1, wherein said alloy material in at least said distal section exhibits an unloading plateau stress of between about 170 and 400 MPa.

6. The medical guidewire of claim 5, wherein said alloy material in at least said distal section exhibits an unloading plateau stress of between about 170 and 320 MPa.

7. The medical guidewire of claim 1, wherein said alloy material in at least said distal section exhibits a loading plateau stress of up to about 500 MPa.

8. The medical guidewire of claim 1, wherein said occlusion device comprises a compliant balloon adhesively mounted on said distal section so as to substantially occlude, when inflated, a blood vessel in which said guidewire is placed.

9. The medical guidewire of claim 8, further comprising an opening formed in a wall of said lumen so as to be in fluid communication with the interior surface of said balloon.

10. A hollow medical guidewire adapted to have a medical device ride over it to a location within a patient, said guidewire comprising:

an elongate hollow body having distal and proximal sections, said body being constructed at least partially from a transformational, non-linear, superelastic nickel-titanium alloy material which transforms upon the application of stress from an austenite phase to a martensite phase, wherein when said alloy material is loaded to a stress value corresponding to the end of elastic deformation of the martensite phase, said alloy material exhibits a substantially constant stress upon unloading of not less than about 170 MPa;

an occlusion device mounted on said distal section of said body; and

a lumen formed in said body extending from said proximal section to said distal section.

11. The medical guidewire of claim 10, wherein said alloy material has a nickel content in the range of about 50.0%-51.5% atomic weight.

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

13. The medical guidewire of claim 10, wherein said alloy material exhibits a substantially constant stress upon unloading of about 200 MPa.

14. The medical guidewire of claim 10, wherein said alloy material has recoverable strain for a given stress of between about 1% and 8%.

15. A medical guidewire adapted to have a medical device ride over it to a location within a patient, said guidewire comprising:

an elongate body having distal and proximal sections, said body being at least partially constructed from a transformation, non-linear, superelastic nickel titanium alloy material, at least said distal section of said body exhibits recoverable strain for a given stress;

said distal section being constructed from a first nickel titanium alloy section having sufficient flexibility to navigate the guidewire through the patient, said first nickel titanim alloy section exhibiting an unloading plateau stress of not less than about 170 Mpa;

said proximal section being constructed from a second nickel titanium alloy section having sufficient stress to provide the guidewire with pushability and trackability for advancing the guidewire through the patient and for riding a medical device over the guidewire; and

an occlusion device on said distal section of said body.

16. The medical guidewire wire of claim 15, wherein said nickel content is between about 50.0 and 51.5% atomic weight.

17. The medical guidewire of claim 16, wherein said nickel content is about 50.8% atomic weight.

18. The medical guidewire of claim 15, wherein said alloy material in at least said distal section has recoverable strain of between about 1% and 8%.

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