STENT DEVICE DELIVERY SYSTEM WITH A HEAT SHRINK RESISTANT SUPPORT MEMBER

• US 20110137402A1
• 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 10,278,845 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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 and an outer sheath overlaying the stent device in a radially compact, delivery configuration of the stent device. The system also includes a pull member for pulling proximally on to retract the outer sheath, wherein a portion of the outer sheath is heat shrunk radially onto a relatively heat shrink resistant support member in order to capture a distal portion of the pull member radially between the outer sheath and the heat shrink resistant support member.

Claims

1. A stent device delivery system, comprising:

a stent device;

an outer sheath overlaying the stent device in a radially compact, delivery configuration of the stent device, the outer sheath is retractable to allow the stent device to radially expand to a deployed configuration; and

a pull member for pulling proximally on to retract the outer sheath, wherein a portion of the outer sheath is heat shrunk radially onto a relatively heat shrink resistant support member in order to capture a distal portion of the pull member radially between the outer sheath and the heat shrink resistant support member.

2. The stent device delivery system of claim 1, wherein the captured portion of the pull member extends an axial distance of at least about 1 inch (3 cm).

3. The stent device delivery system of claim 1, wherein the captured portion of the pull member defines a flattened profile with respect to the radial direction.

4. The stent device delivery system of claim 1, wherein the portion of the outer sheath is heat shrunk onto the heat shrink resistant support member at an axial portion of the outer sheath that is proximal of the stent device.

5. The stent device delivery system of claim 1, wherein the outer sheath comprises a first layer and a reinforcement layer that are laminated together and the captured portion of the pull member is positioned radially between the first layer and the reinforcement layer.

6. The stent device delivery system of claim 5, wherein the reinforcement layer and the first layer are laminated by a glue layer.

7. The stent device delivery system of claim 6, wherein the pull member is embedded in the glue layer.

8. The stent device delivery system of claim 5, wherein the first layer and the reinforcement layer are heat shrunk onto the heat shrink resistant support member to capture the pull member radially between the outer of the two layers and the support member.

9. 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, the fold-over portion is axially movable relative to the stent device by moving the inner layer relative to the outer layer, thereby allowing the outer sheath to be retracted from the stent device and the outer layer is heat shrunk onto the heat shrink resistant support member to capture the pull member.

10. The stent device delivery system of claim 9, wherein the outer layer includes a first layer and a reinforcement layer laminated together, whereby the first layer and the reinforcement layer are heat shrunk onto the heat shrink resistant support member to capture the pull member.

11. The stent device delivery system of claim 10, further comprising an inner catheter extending radially and axially within the stent device, wherein the inner layer is fixed relative to the inner catheter at a position proximal of the stent device.

12. The stent device delivery system of claim 11, wherein a proximal end of the inner layer is heat shrunk radially onto the inner catheter to fix it thereto.

13. The stent device delivery system of claim 12, wherein the proximal end of the inner layer of the outer sheath, which is fixed relative to the inner catheter, peels away under a pulling force as the fold-over portion, which defines the rolling edge, meets it and is pulled further proximally during retraction of the outer sheath.

14. The stent device delivery system of claim 1, wherein the pull member is a pull wire that is radially flattened at the captured portion.

15. The stent device delivery system of claim 1, comprising an inner catheter extending axially and radially within a lumen of the stent device, wherein the stent device is held fixed relative to the inner catheter by a holding mechanism.

16. The stent device delivery system of claim 15, wherein the holding mechanism is, at least in part, a stent bed presented by the inner catheter and 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, wherein 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.

17. A method of making a stent device delivery system, comprising:

providing a stent device and an outer sheath overlaying the stent device in a radially compact delivery configuration of the stent device, wherein the outer sheath is retractable to allow the stent device to radially expand to a deployed configuration;

providing a pull member for attachment to the outer sheath to be subjected to a proximal pulling force to effect retraction of the outer sheath;

positioning a relatively heat shrink resistant support tube within the outer sheath, at a position axially proximal of the stent device; and

radially heat shrinking a portion of the outer sheath onto the support tube to capture the pull member radially between the outer sheath and the support tube.

18. The method of claim 17, further comprising forming the outer sheath to include a first layer and a reinforcement layer and laminating the reinforcement layer to the first layer to retain the pull member radially between the first layer and the reinforcement layer.

19. The method of claim 18, wherein lamination of the first layer and the reinforcement layer is effected by gluing the first layer to the reinforcement layer and further comprises the step of embedding the pull member in a glue layer gluing the first layer and the reinforcement layer.

20. The method of claim 17, further comprising loading a stent device into a sleeve of polymeric material for forming the outer sheath, cold drawing the sleeve of polymeric material to reduce the diameter of the sleeve and to reduce the diameter of the stent device to put the stent device in the radially compact, delivery configuration to thus provide the stent device with an outer sheath overlaying the stent device in a radially compact, delivery configuration and the outer sheath is retractable to allow the stent device to expand to a radially expanded, deployed configuration.