Stent device delivery system with a varying radial profile pull member

• US 9,717,612 B2
• Filed: 12/01/2010
• Issued: 08/01/2017
• Est. Priority Date: 12/03/2009
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Elssser, Erhard, Forster, Markus, Dietrich, Daniel, Maurer, Alexander, Dorn, Jrgen
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US12/958,123
• Publication Number:
  US 20110137400A1
• Time in Patent Office: 2,435 Days
• Field of Search: 606108, 606200, 623 111, 623 112, 60410304
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9661 the proximal portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

A stent device delivery system and method of making. The stent device delivery system includes a stent device, an outer sheath overlaying the stent device in a radially compact, delivery configuration of the stent device, and a pull member. The outer sheath may include a first layer and a reinforcement layer that are laminated together, a portion of the pull member captured radially between the first layer and the reinforcement layer. At least a partial length of the captured portion of the pull member may be formed with a varying radial profile.

Claims

1. A system comprising:

an inner catheter having a tube coaxially within a tubular sleeve;

a stent device disposed about a distal end of the inner catheter distal of the tubular sleeve;

a longitudinally movable support tube disposed coaxially and radially outside of the tubular sleeve proximal of the stent device;

an outer sheath disposed coaxially and radially outside of the stent device in a cover position, the outer sheath including a first layer, a reinforcement layer, a glue layer disposed between the first layer and the reinforcement layer, and connected coaxially around the support tube using a heatshrink connection proximal to the stent device;

a guide sheath disposed coaxially around the support tube and the outer sheath; and

a pull member having a distal connecting end and a proximal pulling end, wherein the connecting end is disposed between the first layer and the reinforcement layer, at least a portion of the connecting end has a varying radial profile fully within the glue layer, and

the proximal end of the first layer or the reinforcement layer is proximate the support tube proximal end.

2. The system of claim 1 wherein at least a portion of the varying radial profile has sinusoidal undulations.

3. The system of claim 2 wherein the varying radial profile extends along at least half of the entire length of the connecting end of the pull member disposed between the first layer and the reinforcement layer.

4. The system of claim 3 wherein the varying radial profile extends along substantially the entire length of the connecting end of the pull member disposed between the first layer and the reinforcement layer.

5. The system of claim 4 wherein the varying radial profile includes a textured surface, selected from the group consisting of stippling, scoring and cross hatching.

6. The system of claim 2 wherein the outer sheath further comprises an inner layer, an outer layer and a fold-over portion connecting the inner layer and the outer layer, and axial movement of the outer layer relative to the inner layer causes axial movement of the fold-over portion relative to the stent device allowing the fold-over portion to be moved proximal of the stent device in order to retract the outer sheath from the stent device.

7. The system of claim 6 wherein at least one of the first layer and the reinforcement layer is a cold drawn layer of plastic material.

8. The system of claim 6 wherein the glue layer is laminarly disposed between the first layer and the reinforcement layer.

9. The system of claim 2 wherein the outer sheath is retractable from a distal-most end of the stent device to a proximal-most end of the stent device to allow for radial expansion of the stent device to a deployed configuration, the inner catheter extends radially and axially within a lumen of the stent device and provides a stent bed upon which the stent device is located so that the radial inner surface of the stent device engages a radial outer surface of the stent bed, and the stent bed defines an inwardly tapering profile, narrowing in radius from a distal portion of the stent device and past a middle of the stent device to a proximal portion of the stent device, the proximal portion being proximate the proximal-most end.

10. The system of claim 2 wherein the reinforcement layer and the glue layer are skived near the proximal end of the outer sheath.

11. The system of claim 2 wherein the varying radial profile comprises a wire with periodic undulations and a period of the undulations is larger than a width of the wire.

12. the system of claim 2 wherein the varying radial profile comprises a wire with undulations having a peak, wherein the number of peaks is greater than three.

13. The system of claim 1 wherein the varying radial profile extends along at least half of the entire length of the connecting end disposed between the first layer and the reinforcement layer.

14. The system of claim 13 wherein the varying radial profile extends along substantially the entire length of the captured portion of the pull member.

15. The system of claim 14 wherein the varying radial profile includes a textured surface, selected from the group consisting of stippling, scoring and cross hatching.

16. The system of claim 1 wherein the outer sheath further comprises an inner layer, an outer layer and a fold-over portion connecting the inner layer and the outer layer, and axial movement of the outer layer relative to the inner layer causes axial movement of the fold-over portion relative to the stent device allowing the fold-over portion to be moved proximal of the stent device in order to retract the outer sheath from the stent device.

17. The system of claim 16 wherein at least one of the first layer and the reinforcement layer is a cold drawn layer of plastic material.

18. The system of claim 1 wherein the glue layer is laminarly disposed between the first layer and the reinforcement layer.

19. The system of claim 1 wherein the outer sheath is retractable from a distal-most end of the stent device to a proximal-most end of the stent device to allow for radial expansion of the stent device to a deployed configuration, the inner catheter extends radially and axially within a lumen of the stent device and provides a stent bed upon which the stent device is located so that the radial inner surface of the stent device engages a radial outer surface of the stent bed, and the stent bed defines an inwardly tapering profile, narrowing in radius from a distal portion of the stent device and past a middle of the stent device to a proximal portion of the stent device, the proximal portion being proximate the proximal-most end.

20. The system of claim 1 wherein the pull member distal end lies between proximal and distal ends of the stent device.

21. The system of claim 1 wherein the reinforcement layer and the glue layer are skived near the proximal end of the outer sheath.