Stent device delivery system with a heat shrink resistant support member

• US 10,278,845 B2
• Filed: 12/01/2010
• Issued: 05/07/2019
• 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: Dorn, Jurgen, Forster, Markus, Dietrich, Daniel
• Primary Examiner(s): Hollm, Jonathan A
• Application Number:
  US12/958,220
• Publication Number:
  US 20110137402A1
• Time in Patent Office: 3,079 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 2/966 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 system comprising:

a stent device having a longitudinal axis and radial lines lying in a plane perpendicular to the longitudinal axis and extending outward from the longitudinal axis;

a support member;

a retractable outer sheath having a proximal and distal end overlaying the stent device, at least a portion of the outer sheath radially connected to the support member through an adhesive or heat shrunk connection, the outer sheath further comprising an outer layer, an inner layer, and a fold-over portion connecting the outer layer and the inner layer, the fold-over portion being movable relative to the stent device by moving the outer layer relative to the inner layer, thereby allowing the outer sheath to be retracted from the stent device; and

a pull member for retracting the outer sheath captured between the support member and the outer sheath, wherein;

the support member is heat shrink resistant and is proximally movable with respect to the stent device during re-traction of the outer sheath,

the outer layer includes a first layer and a reinforcement layer glued together and the first layer and the reinforcement layer are heat shrunk onto the support member and capture the pull member between the first layer and the reinforcement layer, and

the outer sheath tapers outwardly from its proximal to distal end, the taper increasing a diameter of the outer sheath along a portion of the outer sheath over the stent device.

2. The system of claim 1, wherein a proximal end of the inner layer of the outer sheath, which is connected to an inner catheter, peels away under a pulling force as the fold-over portion, which defines a rolling edge, meets the proximal end of the inner layer and is pulled further proximally during retraction of the outer sheath.

3. The system of claim 1, further comprising a stent bed, comprising a tacky material and having a proximal end and a distal end disposed beneath the stent device and tapering inwardly from the distal end of the stent bed to the proximal end of the stent bed.

4. The system of claim 3, wherein the pull member extends to a distal end of the stent device.

5. The system of claim 3, wherein the stent bed comprises adjacent bands that inwardly taper from the distal end of the stent bed to the proximal end of the stent bed.

6. The system of claim 5, wherein the distal end of the outer sheath has a larger outside diameter than the proximal end of the outer sheath.

7. The system of claim 1, wherein a proximal portion of the stent device is compressed to a greater extent than a distal portion of the stent device.

8. The system of claim 7, further comprising a stent bed comprising adjacent bands that inwardly taper from the distal end of the stent bed to the proximal end of the stent bed.

9. The system of claim 8, wherein the stent bed comprises adjacent bands that inwardly taper from the distal end of the stent bed to the proximal end of the stent bed and the distal end of the outer sheath has a larger outside diameter than the proximal end of the outer sheath.

10. A system defining a longitudinal axis and having a radial direction by radial lines lying in a plane perpendicular to the longitudinal axis and extending outward from the longitudinal axis, the system comprising:

an inner catheter;

an outer sheath having an inner layer, an outer layer, and a fold-over portion connecting the inner layer and the outer layer at a distal of the outer sheath;

a reinforcement layer positioned radially outside of the outer layer and laminated to the outer sheath, the reinforcement layer extending to a distal end of the outer sheath proximate the fold-over portion;

a pull member embedded in a glue layer between the outer layer and the reinforcement layer, the pull member extending to a distal end of the outer sheath and coupled to the outer sheath by heat shrinking the outer layer and the reinforcement layer onto a heat shrink resistant support tube radially within the outer layer;

a stent bed having a tapering profile that tapers radially inwardly from a distal end to a proximal end; and

a stent device in contact with the stent bed and in contact with an inner surface of the inner layer of the outer sheath to radially confined the stent device;

wherein;

the inner layer is coupled to the inner catheter at a connecting portion located proximally of the stent device and the outer layer extends further proximally from the connecting portion to a distal portion of the pull member, the inner layer coupled to the inner catheter by heat shrinking the inner layer onto the inner catheter at the connecting portion that is heat shrink resistant such that the outer sheath is peelable from the inner catheter during retraction of the outer sheath,

the outer layer being axially movable in a proximal direction relative to the inner catheter to cause the fold-over portion to move proximally thereby retracting the outer sheath when the pull member is pulled proximally, and

a distal portion of the pull member between the outer layer and the reinforcement layer defines a lower radial profile as compared to a proximal portion of the pull member.

11. The system of claim 10, wherein the inner layer, the outer layer, and the reinforcement layer are cold drawn along an axial portion of the outer sheath overlaying the stent device, and wherein the axial portion of the outer sheath overlaying the stent device is not heat shrunk such that a proximal portion of the outer sheath has a reduced diameter relative to the axial portion of the outer sheath overlaying the stent device.

12. The system of claim 11, wherein the outer sheath is configured to maintain a radial gap between the inner layer and the outer layer during retraction of the outer sheath by the inner layer having a tapering profile such that the inner layer has a larger outside diameter at a distal end and a smaller outside diameter at a proximal end and the outer layer having a reverse tapering profile such that the outer layer has a smaller diameter at a distal end and a larger diameter at a proximal end.

13. A method comprising:

providing a stent device, having a distal end, and an outer sheath overlaying the stent device, wherein the outer sheath is retractable to allow the stent device to radially expand to a deployed configuration;

forming the outer sheath to include a reinforcement layer, an outer layer, and an inner layer, a fold-over portion connecting the inner layer and the outer layer, the fold-over portion being movable relative to the stent device by moving the outer layer relative to the inner layer, thereby allowing the outer sheath to be retracted from the stent device;

providing a pull member for attachment to the outer sheath wherein the pull member extends distally to the distal end of the stent device;

laminating, by gluing, the reinforcement layer to the outer layer and embedding the pull member in the glue to retain the pull member radially between the outer layer and the reinforcement layer;

positioning a 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 capturing the pull member radially between the outer sheath and the support tube, the support tube being movable proximally with respect to the stent device during retraction of the outer sheath.