Stent Device Delivery System with an Outer Sheath Polymeric Reinforcement Layer

• US 20170156905A1
• Filed: 02/17/2017
• Published: 06/08/2017
• 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, Dorn, Jurgen
• Granted Patent: US 10,449,072 B2
• Time in Patent Office: 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 system comprising a catheter having:

an inner catheter with a distal stent bed;

a guide sheath having a tapered distal end;

a retractable sheath overlaying the stent bed and having an inner portion, an outer portion, and a fold-over portion,

and

a substantially straight pull member configured to retract the retractable sheath, wherein a distal portion of the pull member is captured radially between a first layer and a reinforcement layer,

wherein

in a cover position the fold-over portion is distal of the distal end of the stent bed, in a deploy position the fold-over portion is proximal of the proximal end of the stent bed,

a proximal end of the outer portion underlies the guide sheath,

and

the retractable sheath comprises the first layer laminated to the reinforcement layer.

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

3. The system of claim 2 wherein the transition portion includes the first layer and the reinforcement layer.

4. The system of claim 1 wherein the outer portion includes the first layer and the reinforcement layer.

5. The system of claim 4 wherein the inner portion includes the reinforcement layer and the reinforcement layer is a tube.

6. The system of claim 5 wherein an outer surface of the retractable sheath contains the reinforcement layer.

7. The system of claim 6 wherein the reinforcement layer extends from a distal end of the outer portion to proximal of the stent bed.

8. A system comprising:

an inner catheter comprising a distal stent bed region and a guide 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 proximal end and a distal end and wherein the slit region has a plurality of axially distributed slits extending through a wall of the inner tube;

a stent disposed on the stent bed region of the inner catheter wherein a distal end of the inner tube and the tubular sleeve are disposed proximally of the stent;

a guide sheath having a tapered distal end and having a proximal end extending to a proximal end of the inner catheter wherein the guide sheath is disposed coaxially outside of the inner catheter guide region;

a retractable sheath overlaying the stent bed and having an inner portion, an outer portion, and a fold-over portion;

and

a substantially straight pull member configured to retract the retractable sheath, wherein a distal portion of the pull member is captured radially between a first layer and a reinforcement layer,

wherein

in a cover position the fold-over portion is distal of a distal end of the stent, in a deploy position the fold-over portion is proximal of a proximal end of the stent bed,

a proximal end of the outer portion underlies the guide sheath,

the retractable sheath comprises a layer laminated to a reinforcement layer,

and

the outer portion ends proximal of the stent.

9. The system of claim 8 wherein the outer portion includes the first layer and the reinforcement layer.

10. The system of claim 9 wherein the inner portion includes the reinforcement layer and the reinforcement layer is a tube.

11. The system of claim 10 wherein an outer surface of the retractable sheath contains the reinforcement layer.

12. A system comprising:

an inner catheter comprising a distal stent bed region and a guide 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 proximal end and a distal end and wherein the slit region has a plurality of axially distributed slits extending through a wall of the inner tube;

a stent disposed on the stent bed region of the inner catheter wherein a distal end of the inner tube and a distal end of the tubular sleeve are disposed proximally of the stent region;

a guide sheath having a tapered distal end and having a proximal end extending to a proximal end of the catheter wherein the guide sheath is disposed coaxially outside of the guide region of the inner catheter;

a retractable sheath overlaying the stent bed region and having an inner portion, an outer portion, and a fold-over portion;

and

wherein

in a cover position the fold-over portion is distal of a distal end of the stent, in a deploy position the fold-over portion is proximal of a proximal end of the stent bed region, and a proximal end of the outer portion underlies the guide sheath,

the retractable sheath comprises a first layer laminated to a reinforcement layer,

the outer portion includes the first layer and the reinforcement layer,

and

the outer portion ends proximal of the stent.

13. The system of claim 12 wherein the inner portion includes the reinforcement layer and the reinforcement layer is a tube.

14. The system of claim 13 further comprising a substantially straight pull member configured to retract the retractable sheath, wherein a distal portion of the pull member is captured radially between the first layer and the reinforcement layer.

15. The system of claim 14 wherein the inner portion includes the reinforcement layer and the reinforcement layer is a tube.

16. The system of claim 15 wherein an outer surface of the retractable sheath contains the reinforcement layer.