STENT DEVICE DELIVERY SYSTEM WITH AN OUTER SHEATH POLYMERIC REINFORCEMENT LAYER

• US 20110137401A1
• 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: Dietrich, Daniel, Dorn, Jürgen, Forster, Markus
• Granted Patent: US 9,687,369 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A stent device delivery system and method of making. The stent device delivery system includes a stent device and an outer sheath overlaying the stent device in a radially compact, delivery configuration of the stent device. The outer sheath may include a first layer of polymeric material and a reinforcement layer of polymeric material that are laminated together.

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 in order to allow radial expansion of the stent device to a deployed configuration of the stent device, wherein the outer sheath comprises a first layer of polymeric material and a reinforcement layer of polymeric material that are laminated together.

2. The stent device delivery system of claim 1, wherein the reinforcement layer and the first layer overlay, and thus extend along, the stent device.

3. The stent device delivery system of claim 1, wherein the outer sheath comprises a distal portion overlaying the stent device and a transition portion proximal of the stent device, wherein the transition portion tapers radially inwardly in a proximal direction.

4. The stent device delivery system of claim 3, wherein a portion of the outer sheath proximal of the transition portion includes the first layer and the reinforcement layer.

5. The stent device delivery system of claim 3, wherein the tapering portion of the outer sheath includes the first layer and the reinforcement layer.

6. The stent device delivery system of claim 1, wherein the outer sheath comprises a distal portion overlaying the stent device and a portion of the outer sheath proximal of the stent device includes the first layer and the reinforcement layer.

7. The stent device delivery system of claim 6, wherein the reinforcement layer is a tube of material extending from the distal end of the distal portion to the proximal end of the proximal portion.

8. The stent device delivery system of claim 1, further comprising a pull member attached to the outer sheath to be pulled upon in order to retract the outer sheath from the stent device.

9. The stent device delivery system of claim 8, wherein the pull member overlays the stent device and extends to a distal end of the stent device, wherein distal is understood in the context of the outer sheath moving proximally during retraction thereof.

10. The stent device delivery system of claim 8, wherein a distal portion of the pull member is captured radially between the first layer and the reinforcement layer.

11. The stent device delivery system of claim 8, wherein the pull member, the first layer and the reinforcement layer coextend axially for a distance of at least about 1 inch (3 cm).

12. The stent device delivery system of claim 11, wherein the pull member is a pull wire flattened along at least a portion where it is captured radially between the first layer and the reinforcement layer.

13. The stent device delivery system of claim 1, wherein the first layer is in sliding contact with an outer surface of 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.

14. The stent device delivery system of 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.

15. The stent device delivery system of claim 14, wherein the outer layer includes the first layer and the reinforcement layer.

16. The stent device delivery system of claim 2, wherein at least one of the first layer and the reinforcement layer are cold drawn layers of polymeric material along where these layers overlay the stent device.

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

18. The stent device delivery system of claim 1, further comprising a holding means and an inner catheter extending axially through and radially within a lumen of the stent device, the holding means serving to hold the axial position of the stent device relative to the inner catheter during retraction of the outer sheath from the stent device.

19. The stent device delivery system of 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 within a lumen of the stent device and provides a stent bed upon which the stent device is located so that a radially inner surface of the stent device engages a radially 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. The stent device delivery system of claim 1, wherein the outermost surface of the outer sheath is hydrophilic.

21. The stent device delivery system of claim 20, wherein the outermost surface of the outer sheath is the outer surface of the reinforcement layer.