Process for restoring patency to body vessels

• US 4,512,338 A
• Filed: 01/25/1983
• Issued: 04/23/1985
• Est. Priority Date: 01/25/1983
• Status: Expired due to Term

• Current Assignee: World Medical Manufacturing Corp. (Medtronic Plc)
• Original Assignee: Alexander Balko
• Inventors: Shah, Dhiraj M., Balko, Alexander B.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SHEDD, CHARLES W
• Application Number:
  US06/460,842
• Time in Patent Office: 819 Days
• Field of Search: 3/1.4, 128/341, 128/343, 128/345, 604/8, 128/1 R
• US Class Current: 606/108
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• 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 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes

Abstract

A process in which a shape memory alloy such as nitinol wire which has been previously fabricated in its parent phase to form a longitudinally oriented coil of adjacent wire loops and thereafter cooled to its martensite phase and reshaped to a relatively straight shape, is utilized as an intra-luminal device to reinforce or replace a weakened or otherwise damaged vessel. The reformable wire is inserted into the vessel in such a manner to be temperature insulated such that upon the removal of the insulation means, the wire reforms to its coil shape so as to be urged against the internal walls of the damaged vessel and supplies a patent channel through which body fluids may pass. In this manner, removal of the damaged portion of the vessel with the attachment of graft material as a replacement thereto along with the complex surgical techniques required to perform such is avoided.

Claims

1. The process of restoring the patency and/or re-establish continuity of a disrupted hollow body vessel a patient which includes a localized defect disposed intermediate proximal and distal patent vessel portions, comprising inserting at least the forward end of a shape-memory allow wire having a parent phase and a martensite phase and a temperature transformation point therebetween and which wire has been previously formed in its parent phase to form a longitudinally oriented coil of adjacent wire loops and then cooled to its martensite phase and reshaped to an alternate form before insertion along the interior of said vessel past said defect to a position adjacent the proximal patent vessel portion while maintaining the temperature of said wire below its martensite transformation point and thereafter permitting the forward portion of said wire to be warmed above its transformation point so as to initially cause said alternate form to substantially revert to said parent phase coil form and to cause the thus reformed wire loops of the forward wire end to be urged against the interior of said proximal patent vessel portion so as to be at least temporarily positioned thereat and thereafter permit the reformation of the remainder of said coil so as to bridge said localized defect and extend into said distal patent vessel portion, said warming being progressive in the proximal to distal direction.

2. The process of claim 1, said reformed wire loops being substantially circular.

3. The process of claim 1 wherein the martensite transformation temperature of said wire is below the normal temperature range of said body.

4. The process of claim 3 wherein said wire in composed of a Nitinol alloy.

5. The process of claim 1 wherein said warming of said wire takes place by said body.

6. The process of claim 1 wherein the temperature of said wire is regulated by insulating means when initially inserted into said vessel.

7. The process of claim 6 wherein said insulating means is a tube through which said wire is transported to said proximal patent portion after which said tube is progressively withdrawn.

8. The process of claim 7 wherein a tubular graft is positioned over said wire in its alternate form prior to inserting said wire and said graft into said vessel.

9. The process of claim 8 wherein said wire is attached to said graft at least at the forward or proximal end thereof and said wire and graft are positioned in said tube in a crushed compacted form.

10. The process of claim 1 wherein the adjacent loops of said reformed coil are closely spaced to each other so as to essentially form the wall of the vessel in said defective portion thereof.

11. The process of claim 1 wherein a tubular graft is positioned over said wire in its alternate form prior to inserting said wire and said graft into said vessel.

12. The process of claim 1 wherein said wire is continuous.

13. The process of claim 1 wherein said alternate wire form is a substantially straight length thereof.

14. The process of claim 1, said alternate form of said wire being a crushed compacted form adapted for insertion into said body vessel.

15. The process of restoring the patency and/or re-establish continuity of a disrupted hollow body vessel of a patient which includes a localized defect disposed intermediate proximal and distal patent vessel portions, comprising inserting at least the forward end of a shape-memory alloy wire having a parent phase and a martensite phase and a temperature transformation point therebetween which is somewhat below the body temperature of said patent and which wire which has been previously formed in its parent phase to form a longitudinally oriented coil of adjacent wire loops and then cooled to its martensite phase and reshaped to an alternate form before insertion along the interior of said vessel past said defect to a position adjacent the proximal patent vessel portion while maintaining the temperature of said wire below its martensite transformation point and thereafter permitting said wire to be progressively warmed in the proximal to distal direction by the patient'"'"'s body above its transformation point so as to initially cause said alternate form to substantially revert to said parent phase coil form and to cause the thus reformed wire loops of the forward wire end to be urged against the interior of said proximal patent vessel portion so as to be a least temporarily positioned thereat and thereafter permit the reformation of the remainder of said coil so as to bridge said localized defect and extend into position adjacent said distal patent vessel portion.