STENT DEVICE DELIVERY SYSTEM WITH A VARYING RADIAL PROFILE PULL MEMBER

• US 20110137400A1
• Filed: 12/01/2010
• Published: 06/09/2011
• 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: Maurer, Alexander, Elsasser, Erhard, Dietrich, Daniel, Dorn, Jürgen, Forster, Markus
• Granted Patent: US 9,717,612 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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 stent device delivery system, comprising:

a stent device; and

an outer sheath overlaying the stent device in a radially compact, delivery configuration of the stent device, the outer sheath is retractable relative to the stent device to allow radial expansion of the stent device to a deployed configuration, the outer sheath including a first layer and a reinforcement layer that are laminated together; and

a pull member attached to the outer sheath, a portion of the pull member captured radially between the first layer and the reinforcement layer, wherein at least a partial length of the portion of the pull member captured radially between the first layer and the reinforcement layer of the outer sheath is formed with a varying radial profile along said length.

2. The stent delivery system according to claim 1, wherein the varying radial profile extends along at least half of the entire length of the captured portion of the pull member.

3. The stent delivery system according to claim 1, wherein the varying radial profile extends along substantially the entire length of the captured portion of the pull member.

4. The stent device delivery system according to claim 1, wherein the varying radial profile defines pockets within which glue is accommodated.

5. The stent device delivery system according to claim 1, wherein the varying radial profile is substantially periodic.

6. The stent device delivery system according to claim 1, wherein the varying radial profile is provided by a longitudinal undulation of the pull member.

7. The stent device delivery system according to claim 1, wherein the varying radial profile is provided by a transverse undulation of the pull member.

8. The stent device delivery system according to claim 1, wherein the pull member is radially compressed between the first and reinforcement layers to a substantially flattened configuration.

9. The stent device delivery system according to claim 8, wherein the flattened pull member is retained in a state of resilient compression.

10. The stent device delivery system according to claim 1, wherein the varying radial profile includes a textured surface, selected from the group consisting of stippling, scoring and cross hatching.

11. The stent device delivery system according to claim 1, wherein the varying radial profile includes pull member retention means for engaging the internal surfaces of the first and reinforcement layers of the outer sheath.

12. The stent device delivery system according to claim 1, wherein the varying radial profile includes a longitudinally varying component.

13. The stent device delivery system according to claim 1, wherein the varying radial profile includes a transversely varying component.

14. The stent device delivery system according to claim 1, wherein the first layer is in sliding contact with the stent device and the reinforcement layer overlays the stent device so that the first layer and the reinforcement layer move axially relative to the stent device in conjunction as a single laminar structure during retraction of the outer sheath from the stent device.

15. The stent device delivery system according to claim 1, wherein the outer sheath comprises an inner layer, an outer layer and a fold-over portion connecting the inner layer and the outer layer, whereby axial movement of the outer layer relative to the inner layer causes axial movement of the fold-over portion relative to the stent device so that the fold-over portion can be moved proximal of the stent device in order to retract the outer sheath from the stent device, and wherein the outer layer includes the first layer and the reinforcement layer.

16. The stent device delivery system according to claim 1, wherein at least one of the first layer and the reinforcement layer is a cold drawn layer of plastic material.

17. The stent device delivery system according to claim 1, wherein the first layer and the reinforcement layer are laminated together by a glue layer radially between the first layer and the reinforcement layer.

18. The stent device delivery system according to claim 1, wherein a portion of the outer sheath is heat shrunk radially onto a relatively heat shrink resistant support member at an axial portion of the outer sheath that is proximal of the stent device in order to capture the portion of the pull member radially between the outer sheath and the heat shrink resistant support member.

19. The stent device delivery system according to claim 1, wherein the outer sheath is retractable from a distal end of the stent device to a proximal end of the stent device to allow for radial expansion of the stent device to a deployed configuration, an 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 to a proximal portion of the stent device.

20. A method of manufacturing a stent device delivery system comprising:

providing a stent device;

providing an outer sheath to the stent device for retaining the stent device in a radially compact delivery configuration and being retractable relative to the stent device to allow radial expansion of the stent device to a deployed configuration;

providing a pull member to the outer sheath; and

laminating a reinforcement layer to the outer sheath to capture a portion of the pull member radially therebetween, wherein the pull member exhibits a varying radial profile along at least a portion of the captured length.

21. The method according to claim 20, further comprising radially compressing the pull member to a flattened configuration.