Stent with detachable tethers and method of using same

• US 6,716,238 B2
• Filed: 05/10/2001
• Issued: 04/06/2004
• Est. Priority Date: 05/10/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Elliott, Christopher J.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Blanco, Javier G.
• Application Number:
  US09/852,524
• Publication Number:
  US 20020188341A1
• Time in Patent Office: 1,062 Days
• Field of Search: 623/1.11, 623/1.12, 606/108
• US Class Current: 623/1.11
• 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 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
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires

Abstract

A stent delivery system comprising a stent and at least one tether detachably connected to the stent by a connecting member. In one embodiment, the tether may comprise a conductive material and the connecting member may comprise a material subject to degradation upon application of an electrical current. In another embodiment, the connecting member, the stent, and the tether each may have a mechanical strength, where the strength of the connecting member is less than the strength of the stent and the tether. In yet another embodiment, application of electrical current may weaken the connecting member sufficient to enable detachment of the tether. A method of deploying a stent uses the stent delivery device comprising a tether attached to the stent by a connecting member. The tether may be used for accurate positioning of the stent.

Claims

1. A stent delivery system comprising a stent and at least one tether detachably connected to the stent by a connecting member, the tether comprising a conductive material and the connecting member comprises a material selected from a group consisting of:

a solder, a brazing paste, or an adhesive, the material subject to degradation upon application of an electrical current, the conductive material of the tether comprising a wire having a first impedance, and the connecting member having a second impedance higher than the first impedance.

2. The system of claim 1 wherein the stent has a compressed configuration and an expanded configuration, the system further comprising a tubular delivery catheter having a distal portion on which the stent is axially mounted, and an outer sheath over the compressed stent and the delivery catheter, the connecting member comprising a portion of the tether wherein the tether is helically wrapped about the stent to hold the stent in the compressed configuration.

3. The system of claim 2 wherein an intermediate portion of the tether is contained within a proximal portion of the delivery catheter and exits the delivery catheter through an exit hole in the catheter proximal of the distal portion on which the stent is mounted, and a proximal end of the tether is connected to a tether handle located outside of the delivery catheter.

4. The system of claim 1 wherein the tether connects to the stent in a proximal location.

5. The system of claim 1 wherein the tether connects to the stent in a distal location.

6. The system of claim 1 wherein the tether connects to the stent in a medial location.

7. The system of claim 1 wherein said at least one tether comprises a plurality of tethers.

8. The system of claim 1 further comprising a handle attached to the tether for at least one of:

assisting in detachment of the detachable connecting member and retracting the tether after detachment.

9. The system of claim 8 wherein the handle further comprises a stationary pinion and a movable rack attached to the tether, a fixed rack and a spiral gear attached to the tether, or a manipulation rod attached to the tether.

10. The system of claim 1 wherein the stent is a self-expanding stent or a hybrid self-expanding/balloon-expandable stent.

11. The system of claim 1 wherein the conductive material of the tether comprises a copper-monel wire and the material of the connecting member comprises a solder or an adhesive.

12. A method of deploying a stent using a stent delivery device comprising a tether attached to the stent by a connecting member, a tubular delivery catheter having a distal portion on which the stent is axially mounted, and an outer sheath over the compressed stent and the delivery catheter, the connecting member comprising (i) a portion of the tether wherein the tether is helically wrapped about the stent to hold the stent in the compressed configuration, (ii) a solder, a brazing paste, or an adhesive, wherein the tether comprises a conductive wire having a first impedance and the connecting member has a second impedance higher than the first impedance such that the connecting member is subject to degradation upon application of an electrical current, or (iii) a combination of (i) and (ii), the method comprising the steps of:

(a) inserting the stent delivery device into a lumen through an access location;

(b) navigating the stent delivery device to a deployment location;

(c) retracting the outer sheath and expanding the stent from a compressed configuration to an expanded configuration while using the tether to maintain the stent in the deployment location; and

(d) detaching the tether from the stent.

13. The method of claim 12 wherein step (c) further comprises repositioning or reconstraining the stent using the tether once the stent is in an expanded or partially-expanded configuration.

14. The method of claim 12 wherein step (d) comprises applying an electrical current to the tether which causes the connecting member to degrade.

15. The method of claim 12 wherein step (d) further comprises applying an electrical current to the tether which causes the connecting member to degrade prior to applying a tensional or torsional force for causing the connecting member to detach.

16. The method of claim 12 further comprising the steps of:

(e) retracting the detached tether into the delivery device, and

(f) removing the delivery device from the lumen.

17. The method of claim 12 wherein step (c) comprises self-expansion of the stent.

18. The method of claim 12 comprising deploying a stent to repair an ostial lesion.

19. A stent delivery system comprising a stent having a compressed configuration and an expanded configuration, at least one tether detachably connected to the stent by a connecting member, a tubular delivery catheter having a distal portion on which the stent is axially mounted, and an outer sheath over the compressed stent and the delivery catheter, the tether comprising a conductive material and the connecting member comprising a material subject to degradation upon application of an electrical current, the connecting member material comprising a solder, a brazing paste, or an adhesive, the conductive material of the tether comprising a wire having a first impedance, and the connecting member material having a second impedance higher than the first impedance.

20. The system of claim 19 wherein the tether connects to the stent in a proximal location.

21. The system of claim 19 wherein the tether connects to the stent in a distal location.

22. The system of claim 19 wherein the tether connects to the stent in a medial location.

23. The system of claim 19 wherein said at least one tether comprises a plurality of tethers.

24. The system of claim 19 further comprising a handle attached to the tether for at least one of:

assisting in detachment of the detachable connecting member and retracting the tether after detachment.

25. The system of claim 19 wherein the stent is a self-expanding stent or a hybrid self-expanding/balloon-expandable stent.

26. The system of claim 19 further comprising a power supply connected to a tether.

27. The system of claim 26 wherein the power supply comprises a 9 V battery.

28. The system of claim 19 wherein an intermediate portion of the tether is contained within a proximal portion of the delivery catheter and exits the delivery catheter through an exit hole in the catheter proximal of the distal portion on which the stent is mounted, and a proximal end of the tether is connected to a tether handle located outside of the delivery catheter.