Temporary stent

• US 5,441,516 A
• Filed: 03/03/1994
• Issued: 08/15/1995
• Est. Priority Date: 03/03/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Tran, Thomas T., Schmaltz, Dale F., Wang, Lixiao, Hastings, Roger, Holman, Thomas J., Willard, Martin R.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/206,139
• Time in Patent Office: 530 Days
• Field of Search: 606/191, 606/194, 606/195, 606/196, 606/197, 606/198, 606/200, 604/8, 604/53, 604/95-106, 128/898, 623/1, 623/12
• US Class Current: 606/198
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• 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 2250/0059 temporary
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

Apparatus including a spiral coil body as a stent for temporarily supporting a body vessel internally, the spiral coil body being adjustable in diameter by relative rotation of at least one of the ends of the body from a proximal location.

Claims

1. Removable apparatus for temporarily supporting a region of a vessel in a body, the apparatus comprising a catheter having proximal and distal end portions, an elongate flexible shaft portion and a stent portion carried by a distal end portion of the shaft portion

the shaft portion including an elongate inner tubular member having an exterior, and an elongate outer tubular member concentrically positioned around the exterior of the inner tubular member, each of said tubular members having a proximal end and a distal end, the tubular members being movable axially with respect to each other and the distal end of the inner tubular member extending distally beyond the distal end of the outer tubular member, wherein at least the distal elongate portions of the inner and outer tubular members are comprised of closely wound helices of metal wire;

the stent portion being comprised of a spring-like spiral coil body having proximal and distal end portions, the coil body being positioned with respect to the shaft portion of the catheter so that the distal end portion of the inner tubular member extends longitudinally through the coil body, the distal end portion of the coil being fixedly secured to the inner tubular member and the proximal end portion of the coil body being fixedly secured to the outer tubular member whereby axial rotation of at least one tubular member effects rotation of at least one of the ends of the coil body with respect to the other and, depending on the direction of the rotation, enlarges or decreases the diameter of the spiral coil body, and

means at the proximal end portion of the catheter operatively connected to the shaft portion for effecting the axial rotation of the at least one tubular member and controlling same.

2. The apparatus of claim 1 including heating means associated with the catheter for heating the spiral coil body to an elevated temperature.

3. The apparatus of claim 1 wherein the spiral coil body is of plastic.

4. The apparatus of claim 1 wherein the spiral coil body is of metal.

5. The apparatus of claim 4 including electrical means associated with the catheter and in communication with the spiral coil body for heating the spiral coil body to an elevated temperature.

6. The apparatus of claim 5 wherein the electrical means passes AC current throught the coil at a frequency which does not affect the body.

7. The apparatus of claim 6 wherein the frequency of the AC current is above about 100,000 cycles per second.

8. The apparatus of claim 4 wherein the metal is a nitinol alloy.

9. The apparatus of claim 1 including a retractable polymeric sheath associated with the catheter and in communication with the stent portion for selectively covering and uncovering the stent portion.

10. The apparatus of claim 1 wherein the spiral coil body is comprised of at least one ribbon-like metal winding which is rectangular in cross-section.

11. The apparatus of claim 1 wherein the spiral coil winding is comprised of at least one metal winding including a polymeric coating thereon.

12. The apparatus of claim 1 including radiopaque marker means associated with the apparatus for identifying and locating the stent portion, said marker means being proximal to said stent portion.

13. The apparatus of claim 1 wherein the initial configuration of the spiral coil body is constricted for fail-safe purposes, said apparatus being constructed and arranged to be held in an expanded state, and to automatically return to its constricted state upon release.

14. The apparatus of claim 1 wherein the closely wound helices each comprise a single layer.

15. The apparatus of claim 1 wherein the closely wound helices each comprises at least two oppositely wound windings forming multiple layers.

16. The apparatus of claim 1 wherein the closely wound helices are each of at least the two filar double layer type.

17. The apparatus of claim 16 wherein the closely wound helices are of at least the four filar double layer type.

18. The apparatus of claim 1 wherein a proximal elongate portion of the outer tubular member is comprised of a polymeric/braided composite joined to a distal wire wound portion.

19. The apparatus of claim 18 wherein the polymeric portion of the composite is polyimide.

20. The apparatus of claim 18 wherein the wire wound portion is of at least the four filar double layer type.

21. The apparatus of claim 1 wherein a proximal elongate portion of the inner tubular member is comprised of a polymeric/braided composite joined to a distal wire wound portion.

22. The apparatus of claim 21 wherein the polymeric portion of the composite is polyimide.

23. The apparatus of claim 21 wherein the wire wound portion is of at least the four filar double layer type.

24. The apparatus of claim 1 including means connected to the proximal end portion of the catheter for introducing infusion fluid through one of the tubular members.

25. The apparatus of claim 24 wherein the infusion fluid includes a medicament.

26. The apparatus of claim 1 wherein the axial movement of the inner and outer tubular members with respect to each other is effected by a two-piece telescoping arrangement, one piece being connected to the inner tubular member, the other piece being connected to the outer tubular member.

27. The apparatus of claim 1 wherein at least a portion of the length of either the inner or outer tubular member is comprised of a stainless steel hypotube.

28. The apparatus of claim 1 wherein the spiral coil body is comprised of a plurality of parallel wound members.

29. Removable apparatus for temporarily supporting a region of a vessel in a body, the apparatus comprising a catheter having proximal and distal end portions, an elongate flexible shaft portion and a stent portion carried by a distal end portion of the shaft portion;

the shaft portion including an elongate inner tubular member having an exterior and an elongate outer tubular member concentrically positioned around the exterior of the inner tubular member, each of said tubular members having a proximal end and a distal end, the tubular members being movable axially with respect to each other and the distal end of the inner tubular member extending distally beyond the distal end of the outer tubular member;

the stent portion being comprised of a spring-like spiral coil body, said coil body being further comprised of at least two parallel wound ribbons and having proximal and distal end portions, the coil body being positioned with respect to the shaft portion of the catheter so that the distal end portion of the inner tubular member extends longitudinally through the coil body, the distal end portion of the coil being fixedly secured to the inner tubular member and the proximal end portion of the coil body being fixedly secured to the outer tubular member whereby axial rotation of at least one tubular member effects rotation of at least one of the ends of the coil body with respect to the other and, depending on the direction of the rotation, enlarges or decreases the diameter of the spiral coil body, and

means at the proximal end portion of the catheter operatively connected to the shaft portion for effecting the axial rotation of the at least one tubular member and controlling same.

30. Removable apparatus for temporarily supporting a region of a vessel in a body, the apparatus comprising a catheter having proximal and distal end portions, an elongate flexible shaft portion and a stent portion carried by a distal end portion of the shaft portion;

the shaft portion including an elongate inner tubular member having an exterior, an elongate outer tubular member concentrically positioned around the exterior of the inner tubular member, each of said tubular members having a proximal end and a distal end, said tubular members being movable axially with respect to each other, a two-piece telescoping arrangement for effecting said longitudinal relative movement between the inner and outer tubular members, one piece being connected to the inner tubular member, the other piece being connected to the outer tubular member, said telescoping arrangement further comprising means for preventing rotation of the two pieces relative to each other, the one piece being adapted to impart rotary turning motion to the inner tubular member, and the distal end of the inner tubular member extending distally beyond the distal end of the outer tubular member;

the stent portion being comprised of a spring-like spiral coil body having proximal and distal end portions, the coil body being positioned with respect to the shaft portion of the catheter so that the distal end portion of the inner tubular member extends longitudinally through the coil body, the distal end portion of the coil being fixedly secured to the inner tubular member and the proximal end portion of the coil body being fixedly secured to the outer tubular member whereby axial rotation of at least one tubular member effects rotation of at least one of the ends of the coil body with respect to the other and, depending on the direction of the rotation, enlarges or decreases the diameter of the spiral coil body, and

means at the proximal end portion of the catheter operatively connected to the shaft portion for effecting the axial rotation of the at least one tubular member and controlling same.

31. The apparatus of claim 30 including mechanical means for increasing the ratio of the number of turns from input to output, the means being operatively associated/connected with the telescoping piece for effecting rotational input and output between it and the inner tubular member and imparting a mechanical advantage to the output.

32. The apparatus of claim 31 wherein the mechanical means includes a gear arrangement.