Stent device delivery system with an outer sheath polymeric reinforcement layer

• US 10,449,072 B2
• Filed: 02/17/2017
• Issued: 10/22/2019
• 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:
  US15/436,597
• Publication Number:
  US 20170156905A1
• Time in Patent Office: 977 Days
• 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 delivery system having a delivery configuration and a deployed configuration, the stent delivery system comprising:

an inner catheter with a distal stent bed;

a retractable sheath overlaying the distal stent bed, the retractable sheath comprising;

a distal section comprising an inner portion laminated to an outer portion; and

a fold-over portion between the inner portion and the outer portion, the fold-over portion positioned distal of the distal stent bed in the delivery configuration and proximal of the distal stent bed in the deployed configuration; and

a substantially straight pull member configured to retract the retractable sheath, wherein a distal portion of the pull member extends into the distal section of the retractable sheath and is captured radially between the inner portion and the outer portion.

2. The stent delivery system of claim 1, wherein the outer portion of the retractable sheath comprises a transition portion proximal of the distal stent bed, wherein the transition portion tapers radially inwardly in a proximal direction.

3. The stent delivery system of claim 2, wherein the transition portion includes the inner portion laminated to the outer portion.

4. The stent delivery system of claim 3, wherein the inner portion is laminated to the outer portion via a glue layer.

5. The stent delivery system of claim 1, wherein the inner portion is laminated to the outer portion via a glue layer.

6. The stent delivery system of claim 5, wherein the pull member extends into the distal section a distance in a range of about 3 cm to about 8 cm.

7. The stent delivery system of claim 1, wherein the retractable sheath is formed from cold-drawn polyethylene terephthalate (PET).

8. The stent delivery system of claim 1, further comprising a guide sheath having a tapered distal end, wherein a distal end of the guide sheath is proximal of the distal stent bed.

9. A stent delivery system having a delivery configuration and a deployed configuration, the stent delivery system comprising:

an inner catheter comprising;

a distal stent bed region; and

a guide region proximal of the distal stent bed region, the guide region comprising an inner tube and a tubular sleeve overlaying the inner tube, wherein the inner tube includes a slit region having a plurality of axially distributed slits extending through a wall of the inner tube;

a stent disposed on the distal stent bed region of the inner catheter;

a retractable sheath overlaying the distal stent bed region, the retractable sheath comprising;

a distal section comprising an inner portion laminated to an outer portion; and

a fold-over portion between the inner portion and the outer portion, the fold-over portion positioned distal of the distal stent bed region in the delivery configuration and proximal of the distal stent bed region in the deployed configuration; and

a substantially straight pull member configured to retract the retractable sheath, wherein a distal portion of the pull member extends into the distal section of the retractable sheath and is captured radially between the inner portion and the outer portion.

10. The stent delivery system of claim 9, wherein the inner portion is laminated to the outer portion via a glue layer.

11. The stent delivery system of claim 10, wherein the pull member extends into the distal section a distance in a range of about 3 cm to about 8 cm.

12. The stent delivery system of claim 11, wherein the retractable sheath is formed from cold-drawn polyethylene terephthalate (PET).

13. The stent delivery system of claim 9, further comprising a guide sheath disposed coaxially outside of the guide region of the inner catheter, the guide sheath comprising a tapered distal end and a proximal end extending to a proximal end of the inner catheter.

14. A stent delivery system having a delivery configuration and a deployed configuration, the stent delivery system comprising:

an inner catheter comprising;

a stent bed; and

a guide portion coupled to a proximal end of the stent bed, the guide portion comprising;

an inner tube including a plurality of axially distributed slits; and

an outer sleeve covering plurality of the axially distributed slits;

a retractable sheath formed from a single polymer tube, the retractable sheath including a folded region comprising a first section of the polymer tube laminated to a second section of the polymer tube, the folded region positioned over the stent bed in the delivery configuration and proximal of the stent bed in the deployed configuration; and

a substantially straight pull member having a distal portion extending into the folded region and captured radially between the first section and the second section.

15. The stent delivery system of claim 14, wherein the first section of the polymer tube is laminated to the second of the ploymer tube section via a glue layer.

16. The stent delivery system of claim 15, wherein the pull member extends into the folded region a distance in a range of about 3 cm to about 8 cm.

17. The stent delivery system of claim 16, wherein the retractable sheath is formed from cold-drawn polyethylene terephthalate (PET).

18. The stent delivery system of claim 14, wherein the stent bed comprises a continuous layer tapering radially inwardly from a distal end of the stent bed to a proximal end of the stent bed.

19. The stent delivery system of claim 14, wherein the stent bed comprises a plurality of axially separated band members, each of the band members having a thickness, wherein the thickness decreases in each of the band members from a distal end of the stent bed to a proximal end of the stent bed.