Apparatus and methods for selectively stenting a portion of a vessel wall

• US 6,231,597 B1
• Filed: 02/16/1999
• Issued: 05/15/2001
• Est. Priority Date: 02/16/1999
• Status: Expired due to Fees

• Current Assignee: Mark E. Deem, Timothy W. Malisch
• Original Assignee: Mark E. Deem, Timothy W. Malisch
• Inventors: Malisch, Timothy W., Deem, Mark E.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/250,710
• Time in Patent Office: 819 Days
• Field of Search: 606/198, 606/108, 606/200, 606/151, 606/153, 606/154, 606/190, 606/191, 606/195, 623/1.12, 623/1.11, 623/1.23
• US Class Current: 623/1.12
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 2017/12068 detachable by heat
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• 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 2210/0033 electrically, e.g. heated by resistor

Abstract

Methods and apparatus for treating vascular abnormalities in highly tortuous vessels are provided comprising a stent having at least one end region that engages a first portion of a circumference of a vessel in a region adjacent to an abnormality to anchor the stent, and a mid-region that engages a second portion of the circumference of the vessel wall to span the abnormality, the second portion having a smaller circumferential extent than the first portion. The mid-region includes a plurality of members that span the abnormality and form a lattice that occludes the abnormality. A delivery system also is provided to deliver the stent within a parent artery and orient the mid-region of the stent to span the abnormality.

Claims

1. Apparatus for treating an abnormality in a vessel, the apparatus comprising:

a tubular member including an end region configured to circumferentially engage a first portion of the vessel adjacent to the abnormality;

a mid-region of the tubular member comprising a plurality of members having a convex outer surface that is configured to engage a second portion of the vessel, the second portion being circumferentially smaller than the first portion and less than a full circumference of the vessel, the plurality of members adapted to span the abnormality; and

a delivery system comprising a first catheter having a distal end adapted to support the tubular member and the mid-region, the first catheter having a lumen and a first gear disposed within the lumen for orienting the mid-region so that it spans the abnormality,

wherein a retractable sheath retains the tubular member on the first catheter.

2. The apparatus of claim 1 wherein the tubular member comprises arcuate portions interconnected by a plurality of bends or cusps.

3. The apparatus of claim 1 wherein the tubular member has a longitudinal axis, the plurality of members oriented generally perpendicular to the longitudinal axis.

4. The apparatus of claim 1 wherein the tubular member comprises a coiled sheet.

5. The apparatus of claim 4 wherein the coiled sheet and mid-region comprises a plurality of openings.

6. The apparatus of claim 1 wherein the first portion is substantially equal to the full circumference of the vessel.

7. The apparatus of claim 1 wherein the first portion is less than the full circumference of the vessel.

8. The apparatus of claim 1 wherein the plurality of members engage one-half of the circumference of the vessel.

9. The apparatus of claim 1 wherein the tubular member further comprises a shape memory metal alloy or biocompatible polymer.

10. The apparatus of claim 1 further comprising a graft material covering the mid-region.

11. The apparatus of claim 1, wherein the first gear comprises a lumen that permits a guide wire to extend beyond the distal end of the first catheter into the vessel.

12. The apparatus of claim 1 further comprising a second catheter configured for insertion into the lumen of the first catheter, the second catheter having a distal end and a second gear disposed on the distal end, the second gear configured to engage the first gear when the second catheter is inserted in the lumen.

13. The apparatus of claim 12, wherein:

p1 the second gear comprises a guide wire tip; and

the first gear comprises a lumen that permits the guide wire tip to extend beyond the distal end of the first catheter into the vessel.

14. Apparatus for deploying a prosthesis to treat a region of a vessel, the prosthesis having a feature that is adapted to be aligned with the region, the apparatus comprising:

a flexible catheter having a distal end adapted to support the prosthesis, a lumen and a first gear disposed within the lumen, the first gear rotating the flexible catheter to orient the feature so that it is aligned with the region;

a torsion catheter configured for insertion into the lumen of the flexible catheter, the torsion catheter comprising an electrical conductor, a distal end, and a second gear disposed on the distal end, the second gear configured to engage the first gear when the torsion catheter is inserted in the lumen; and

a controller that supplies radio-frequency power to the second gear via the electrical conductor.

15. The apparatus of claim 14, wherein the first gear comprises a lumen that permits a guide wire to extend beyond the distal end of the flexible catheter into the vessel.

16. The apparatus of claim 14, wherein:

the second gear comprises a guide wire tip; and

the first gear comprises a lumen that permits the guide wire tip to extend beyond the distal end of the flexible catheter into the vessel.

17. The apparatus of claim 14, wherein:

the first gear comprises a cylindrical portion and a stepped portion having an engagement surface; and

the second gear comprises a cylindrical portion and a stepped portion having an engagement surface that mates with the engagement surface of the first gear.

18. The apparatus of claim 14, wherein the first gear further comprises a longitudinally-oriented marker band.

19. The apparatus of claim 14 wherein the prosthesis is mounted on the catheter by a thermally activated adhesive or polymer.

20. The apparatus of claim 14 wherein the prosthesis is mounted on the catheter by an electrically erodible wire.

21. Apparatus for deploying a prosthesis to treat a region of a vessel, the prosthesis having a feature that is adapted to be aligned with the region, the apparatus comprising:

a flexible catheter having a distal end adapted to support the prosthesis, a lumen and a first gear disposed within the lumen, the first gear rotating the flexible catheter to orient the feature so that it is aligned with the region,

wherein a retractable sheath retains the prosthesis on the catheter.

22. A method of treating an abnormality at a treatment site within a vessel, the method comprising:

providing a stent having a tubular end region comprising at least one curved section having a convex outer surface that is configured to engage a first portion of the vessel, and a mid-region comprising a plurality of members having a convex outer surface that is configured to engage a second portion of the vessel, the second portion being circumferentially smaller than the first portion and less than a full circumference of the vessel;

providing a delivery system for deploying the stent, the delivery system comprising a first catheter having a distal end configured to support the stent, a lumen, and a first gear disposed within the lumen, and a second catheter having a proximal end, a distal end, and a second gear disposed on the distal end;

transluminally disposing the stent at the treatment site;

inserting the second catheter into the lumen of the first catheter;

engaging the second gear with the first gear;

aligning the mid-region of the stent so that the plurality of members span the abnormality, by rotating a proximal end of the second catheter using the first gear to rotate the distal end of the first catheter;

providing a controller that outputs a radio-frequency power; and

coupling the controller to the second catheter to release the stent from the distal end of the first catheter.

23. The method of claim 22 wherein a thermally activated adhesive or polymer retains the stent on the first catheter, and coupling the controller to the second catheter to release the stent from the distal end of the first catheter further comprises selectively resistively heating a portion of the first catheter to melt the adhesive or polymer to release the stent from the first catheter.

24. The method of claim 22 wherein an electrically erodible wire retains the stent on the first catheter, and coupling the controller to the second catheter to release the stent from the distal end of the first catheter further comprises delivering electrical power to the electrically erodible wire to release the stent from the first catheter.

25. A method of treating an abnormality at a treatment site within a vessel, the method comprising:

providing a stent having tubular end region comprising at least one curved section having a convex outer surface that is configured to engage a first portion of the vessel, and a mid-region comprising a plurality of members having a convex outer surface that is configured to engage a second portion of the vessel, the second portion being circumferentially smaller than the first portion;

providing a delivery system for deploying the stent, the delivery system comprising a first catheter having a distal end configured to receive the stent, a lumen, and a first gear disposed within the lumen;

transluminally disposing the stent at the treatment site;

aligning the mid-region of the stent so that the plurality of members span the abnormality by operating the first gear to rotate the distal end of the first catheter, and wherein a retractable sheath retains the stent on the first catheter; and

retracting the sheath to release the stent from the first catheter.