METHOD AND APPARATUS FOR COMPRESSING/LOADING STENT-VALVES

• US 20160228249A1
• Filed: 09/16/2014
• Published: 08/11/2016
• Est. Priority Date: 09/16/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: SIMONIN, Pierre, Biadillah, Youssef, MANTANUS, Luc, LOMBARDI, Fabien, HEFTI, Jean-Luc, DELALOYE, Stphane
• Granted Patent: US 10,245,145 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0091 transparent or translucent

Abstract

Apparatus (40) for compressing a transcatheter cardiac stent-valve (10) comprises: a first compressor stage (100) including a hollow channel (42) with a tapered interior surface configured for compressing a stent-valve in response to longitudinal advancement of the stent-valve within the channel; and a second compressor stage (102) comprising a crimper for compressing a portion of the stent-valve without longitudinal advancement.

Claims

1. An apparatus configured to compress a cardiac stent-valve for loading into a delivery catheter, the apparatus comprising:

a first compressor stage for compressing the stent-valve; and

a second compressor stage coupled or couplable to the first compressor stage and configured to further compress a portion of the stent-valve after passing through the first compressor stage.

2. The apparatus of claim 1, wherein the first compressor stage comprises a hollow channel, and the first compressor stage is configured for progressively compressing the stent-valve in response to, or in association with, longitudinal advancement of the stent-valve within the hollow channel.

3. The apparatus of claim 1, wherein the second compressor stage is configured to compress a portion of the stent-valve at the second compressor stage without advancement of the stent-valve within the second compressor stage.

4. The apparatus of claim 1, wherein the second compressor stage is releasably coupled at, or to be at, an exit of the first compressor stage.

5. The apparatus of claim 1, wherein the second compressor stage comprises a crimper.

6. The apparatus of any claim 5, wherein the crimper comprises a plurality of movable elements.

7. The apparatus of claim 5, wherein the crimper comprises jaws defining a chuck.

8. The apparatus of claim 1, wherein the first and second compressor stages are operated by respective rotary actuators that are rotatable about a common axis, optionally a longitudinal axis of the apparatus.

9. The apparatus of claim 1, wherein the second compressor stage is releasably securable to the first compressor stage using a screw threaded actuator for actuating the second compressor stage.

10. The apparatus of claim 2, wherein the first compressor stage comprises one or more of (i) a mover for applying to a stent-valve within the hollow channel, a pushing force from radially outside the hollow channel;

and/or (ii) a driver for applying a pushing force radially outside the hollow channel to a portion of the mover radially outside the channel.

11. The apparatus of claim 10, wherein the mover comprises a ring from which plural limbs project inwardly, the limbs sliding in slots through a wall of the channel, for applying a pushing force to a stent-valve within the channel.

12. A loading tube apparatus configured to compress and/or load a stent and/or a stent-valve for a delivery catheter, the loading tube apparatus comprising:

a plurality of segments that are assemblable around a portion of a delivery catheter to define a tubular shape; and

at least one retainer for retaining the plurality of segments in the tubular shape.

13. The apparatus of claim 12, wherein the retainer comprises at least one threaded nut, and/or a supporting overtube.

14. A method of loading a stent-valve on to a delivery catheter, the method comprising:

(a) operating a first compressor stage of a compressing apparatus, to advance the stent within a hollow channel of the first compressor stage, and compress the stent in response to, or in association with, the advancement within the hollow channel;

(b) operating a second compressor stage of the compressing apparatus to further compress a portion of the stent without advancing the stent further;

(c) sliding a constraining sheath of the delivery catheter over an exposed portion of the stent-valve that has advanced through the first and second compressor stages.

(d) repeating steps (a), (b), (c) in sequence one or more times to progressively compress and load at least a portion of the stent on to the delivery catheter.

15. A method of loading a stent-valve on to a multiple-sheath delivery catheter, the catheter having first and second sheaths that close over respective portions of the stent-valve from opposite directions, the method comprising:

(a) providing a compressor apparatus having at least a first compressor stage with a hollow channel and configured for progressively compressing the stent-valve in response to or in association with longitudinal advancement of the stent-valve within the hollow channel; and

(b) advancing and compressing at least a portion of the stent-valve using the compressor apparatus;

(c) closing a first sheath over an exposed compressed portion of the stent-valve compressed by the compressor apparatus;

(d) optionally repeating steps (a), (b) and (c) one or more times;

(e) providing a loading tube apparatus around a portion of the delivery catheter by assembling a plurality of segments to define a tubular shape and retaining the segments together with a retainer.

(f) closing the second sheath over a second portion of the stent-valve, using the loading tube at a mouth of the second sheath, to facilitate entry of the second portion of the stent into the second sheath.

16. The method of claim 15, wherein the compressor apparatus further comprises a second compressor stage, and the method further comprises between steps (b) and (c) a further step of operating the second compressor stage without advancing the stent-valve, to further compress locally the portion of the stent-valve to facilitate closing the first sheath in step (c).

17. A method of loading a stent-valve on to a multiple-sheath delivery catheter, the catheter having a distal sheath and a proximal sheath that close over respective portions of the stent-valve from opposite directions, the method comprising:

compressing at least a portion of the stent-valve to engage attachment elements with a stent-holder of the delivery catheter;

closing the distal sheath over a first portion of the stent-valve including the attachment elements; and

closing the proximal sheath over a second portion of the stent-valve.