Highly elastic, adjustable helical coil stent

• US 6,027,516 A
• Filed: 05/04/1995
• Issued: 02/22/2000
• Est. Priority Date: 05/04/1995
• Status: Expired due to Fees

• Current Assignee: The United States of America As Represented By The Secretary of Agriculture
• Original Assignee: United States Department Of Health And Human Services
• Inventors: Wang, Jeffrey Y., Kolobow, Theodor
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/434,822
• Time in Patent Office: 1,755 Days
• Field of Search: 606/1, 606/108, 606/190, 606/191-198, 128/898, 623/1, 623/11, 623/12, 604/96-104
• US Class Current: 623/1.11
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

Abstract

A highly elastic, adjustable helical coil stent (10) has a helical coil (20) which can be contracted around a small diameter catheter (12) for percutaneous insertion into a human body and then can be remotely expanded back to its original shape when positioned at the desired location within the human body. The helical coil is preferably formed of a metal alloy (25) with high elasticity, such as superelastic Nitinol, encased within an elastomer (26). The helical coil is affixed at its distal end to a catheter and affixed at its proximal end to a control tube (30). By rotating the control tube in one direction relative to the catheter (e.g., clockwise), the helical coil contracts and by rotating the control tube in the opposite direction (e.g., counterclockwise), the helical coil expands. The adjustable helical coil stent of the present invention is particularly useful for total or partial heart assist during heart bypass procedures. It can also be used, for example, as a stent for damaged blood vessels or other body conduits in either humans or animals.

Claims

1. An adjustable helical coil stent comprising:

(a) a helical coil having proximal and distal ends, said helical coil formed of a thin superelastic nickel-titanium alloy wire encased within an elastomer having a cross-sectional width which is about four to eight times greater than the width of said wire;

(b) a catheter to which said helical coil is permanently affixed at said distal end; and

,

(c) a control tube, to which said helical coil is permanently affixed at said proximal end, said control tube used for expanding and contracting said helical coil through rotation of said control tube relative to said catheter and for later removal of said helical coil.

2. The adjustable helical coil stent of claim 1 wherein said helical coil can be contracted by rotating said control tube clockwise relative to said catheter.

3. The adjustable helical coil stent of claim 1 wherein said helical coil can be expanded away from said catheter by rotating said control tube counterclockwise relative to said catheter.

4. The adjustable helical coil stent of claim 1 wherein said elastomer is polyester Hytrel.

5. The adjustable helical coil stent of claim 1 wherein said elastomer is coated with heparin or a heparin complex.

6. The adjustable helical coil stent of claim 1 wherein said catheter is a balloon catheter.

7. The adjustable helical coil stent of claim 1 wherein said catheter is a drainage catheter.

8. The adjustable helical coil stent of claim 1 wherein said helical coil is about 3.0 to 8.0 cm. in length and has cross-sectional dimensions of about 4.0 to 8.0 mm in width and 0.1 to 0.2 mm in thickness.

9. The adjustable helical coil stent of claim 1 having a stable expansion ratio of over 50 to 1.

10. The adjustable helical coil stent of claim 1 wherein said catheter is inserted concentrically within said control tube but is free to rotate independent of said control tube.

11. The adjustable helical coil stent of claim 10 wherein the proximal end of said control tube is affixed to an adjustable seal.

12. An adjustable helical coil stent comprising:

(a) a helical coil having proximal and distal ends, said helical coil formed of a thin superelastic nickel-titanium alloy wire encased within an elastomer having a cross-sectional width which is about four to eight times greater than the width of said wire;

(b) a balloon catheter to which said helical coil is permanently affixed at said distal end; and

,

(c) a control tube concentrically overlaying said balloon catheter and to which said helical coil is permanently affixed at said proximal end, said control tube used for expanding and contracting the helical coil through rotation of said control tube relative to said catheter and for later removal of said helical coil.

13. A method for heart assist during heart bypass procedure in a human body comprising the steps of:

(a) selecting an adjustable helical coil stent comprising;

(i) a helical coil having proximal and distal ends, said helical coil formed of a thin superelastic nickel-titanium alloy wire surrounded by an elastomer having a cross-sectional width which is about four to eight times greater than the width of said wire;

(ii) a catheter to which said helical coil is permanently affixed at said distal end; and

,

(iii) a control tube to which said helical coil is permanently affixed at said proximal end, said control tube used for expanding and contracting the helical coil through rotation of said control tube relative to said catheter;

(b) percutaneously inserting said adjustable helical coil stent, with the helical coil in a contracted position, into a blood vessel leading to the heart;

(c) continuing to insert said adjustable helical coil stent until the helical coil is located within one or more chosen heart valves;

(d) adjusting said adjustable helical coil stent until said helical coil is in an expanded position which holds said chosen heart valve(s) open to a desired degree;

(e) performing heart assist;

(f) adjusting said adjustable helical coil stent until said helical coil is back in a contracted position; and

,

(g) removing said adjustable helical coil stent from said human body.

14. The method of claim 13 wherein said one or more chosen heart valves includes the pulmonary valve.

15. The method of claim 13 wherein said one or more chosen heart valves includes the tricuspid valve.

16. The method of claim 13 wherein said helical coil can be contracted by turning said control tube clockwise relative to said catheter.

17. The method of claim 13 wherein said helical coil can be expanded by turning said control tube counterclockwise relative to said catheter.

18. The method of claim 13 wherein said elastomer is polyester Hytrel.

19. The method of claim 13 wherein said elastomer is coated with heparin or a heparin complex.

20. The method of claim 13 wherein said catheter is a balloon catheter.

21. A method for draining fluids from a conduit in a human body comprising the steps of:

(a) selecting an adjustable helical coil stent comprising;

(i) a helical coil having proximal and distal ends, said helical coil formed of a thin superelastic nickel-titanium alloy wire surrounded by an elastomer having a cross-sectional width which is about four to eight times greater than the width of said wire;

(ii) a drainage catheter to which said helical coil is permanently affixed at said distal end; and

,

(iii) a control tube to which said helical coil is permanently affixed at said proximal end, said control tube used for expanding and contracting the helical coil through rotation of said control tube relative to said catheter;

(b) percutaneously inserting said adjustable helical coil stent in a contracted position into said conduit;

(c) adjusting said adjustable helical coil stent until said helical coil is in an expanded position which holds said damaged conduit open;

(d) allowing fluids to drain through said drainage catheter and out of said human body;

(e) adjusting said adjustable helical coil stent until said helical coil is back in a contracted position; and

, (f) removing said adjustable helical coil stent from said human body.