Stent device delivery system with inwardly tapering stent bed

• US 9,724,216 B2
• Filed: 12/01/2010
• Issued: 08/08/2017
• 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: Dietrich, Daniel, Forster, Markus, Gahr, Jeldrik zum, Dorn, Jurgen
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US12/958,089
• Publication Number:
  US 20110137396A1
• Time in Patent Office: 2,442 Days
• Field of Search: 606108, 623 111, 623 112, 623 211
• 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
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes

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 an inner catheter extending axially and radially within a lumen of the stent device. The inner catheter 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. The stent bed may define an inwardly tapering profile, narrowing in radius from a distal portion of the stent device to a proximal portion of the stent device.

Claims

1. A stent device delivery system, comprising:

a stent device;

an outer sheath comprising a first polymer-based layer, a polymer-based reinforcement layer, and a glue layer disposed between the first layer and the reinforcement layer wherein the outer sheath overlays the stent device in a radially compact, delivery configuration of the stent device, the outer sheath 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 outer catheter extending distally from a proximal end of the system and ending proximally of the stent device wherein the outer catheter is disposed radially outward of a proximal end of the outer sheath;

an inner catheter extending axially and radially within a lumen of the stent device and providing 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, 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; and

a pull member for retracting the outer sheath from the stent device, wherein the pull member is embedded in the glue layer, sandwiched between the first layer and reinforcement layer, and a proximal end of the pull member is disposed radially inward of the outer catheter wherein the outer sheath comprises an inner layer contacting an outer surface of the stent device, an outer layer and a fold-over portion connecting the inner layer and the outer layer, so that proximal movement of the outer layer relative to the inner layer causes the fold-over portion to move proximally axially relative to the stent device in a rolling manner and thus enables retraction of the outer sheath.

2. The stent device delivery system of claim 1, wherein the stent bed tapers such that a change in outer diameter of the stent bed divided by axial length over which the change in outside diameter occurs is in the range of 0.0003 to 0.005.

3. The stent device delivery system of claim 2, wherein the stent bed tapers, such that a change in outer diameter of the stent bed divided by axial length over which the change in outside diameter occurs is in the range of 0.0006 to 0.0009.

4. The stent device delivery system of claim 1, wherein the inwardly tapering profile is stepwise.

5. The stent device delivery system of claim 1, wherein the stent bed is axially continuous with respect to the stent device.

6. The stent device delivery system of claim 1, wherein the stent bed is formed by a plurality of axially separated portions, each of the plurality of axially separated portions having a constant outer diameter less than an outer diameter of a distally positioned portion.

7. The stent device delivery system of claim 1, wherein the stent bed is made of a compressible material and the stent device is partially embedded in the stent bed in the radial direction.

8. The stent device delivery system of claim 1, wherein the stent bed is made of a tacky material, which provides a radial as well as an axial holding force on the stent device relative to the inner catheter such that during expansion of the stent device, the stent device peels away from the tacky material of the stent bed.

9. The stent device delivery system of claim 1, wherein the stent bed is formed as a layer on the inner catheter.

10. The stent device delivery system of claim 1, wherein the outer sheath is formed into a tapered profile with the inner layer tapering radially inwardly from the distal portion to the proximal portion of the stent device and the outer layer progressively tapering radially outwardly along an entire length from the distal portion to the proximal portion of the stent device.

11. The stent device delivery system of claim 1, wherein a portion of the outer sheath overlaying the stent device is formed having a tapering profile substantially following the tapering profile of the stent bed.

12. The stent device delivery system of claim 1, wherein the outer sheath is made of a cold drawn polymeric material at least along a portion thereof overlaying the stent device.

13. The stent device delivery system of claim 1, wherein the first polymer-based layer comprises a polyethylene terephthalate.

14. The stent device delivery system of claim 1, wherein the polymer-based reinforcement layer comprises a polyethylene terephthalate.

15. The stent device delivery system of claim 1, wherein the first polymer-based layer and the polymer-based reinforcement layer are directly attached and in contact with the glue layer.