IMPLANT DELIVERY CAPSULE

• US 20190307562A1
• Filed: 06/21/2019
• Published: 10/10/2019
• Est. Priority Date: 10/26/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Patel, Darshin S.
• Granted Patent: US 11,399,937 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Abstract

A delivery system for delivering a stent-mounted heart valve, or other implant, through an introducer sheath. The delivery system includes an elongate catheter supporting a capsule. The capsule contains the stent-mounted heart valve in the crimped condition. The capsule includes a protrusion extending from its outer surface for urging the sheath away from the outer surface capsule as it moves therethrough, thereby reducing an average peak push force resulting from advancement of the capsule through the sheath.

Claims

1. A delivery system for delivering a stent mounted heart valve through a sheath, the delivery system comprising:

an elongate catheter having proximal and distal ends, the stent mounted heart valve crimped at the distal end of the catheter;

a capsule extending around and enclosing the crimped stent mounted heart valve, the capsule having a distal end with a capsule diameter; and

a protrusion extending from an outer surface of the capsule for urging the sheath away from the capsule, thereby reducing an average peak push force resulting from advancement of the capsule through the sheath.

2. The delivery system of claim 1, further comprising:

a nosecone coupled at its proximal end to a distal end of the capsule, the nosecone including a tapered surface having a gradually increasing diameter from a distal end of the nosecone towards the proximal end of the nosecone;

an inner catheter extending through the elongate catheter, capsule and stent mounted heart valve, the inner catheter supporting the nosecone on its distal end,

wherein distal advancement of the inner catheter relative to the elongate catheter advances the stent mounted heart valve out of the capsule.

3. The delivery system of claim 1, wherein a maximum diameter of the protrusion is greater than a maximum diameter of the delivery system.

4. The delivery system of claim 1, wherein a maximum diameter of the protrusion is at least 1.002 times the capsule diameter.

5. The delivery system of claim 4, wherein the maximum diameter of the protrusion is 1.002 times to 1.045 times the capsule diameter.

6. The delivery system of claim 5, wherein an upper tolerance limit of the peak push force is less than 40 Newtons.

7. The delivery system of claim 5, wherein an upper tolerance limit of the peak push force is less than 33 Newtons.

8. The delivery system of claim 1, further comprising the expandable delivery sheath, the sheath having a central lumen sized and configured to receive the elongate catheter and the capsule, wherein the central lumen defines a starting inner diameter less than the capsule diameter.

9. The delivery system of claim 1, wherein the protrusion has a smooth and continuous surface.

10. The delivery system of claim 1, wherein the protrusion is positioned on a distal region of the capsule and extends circumferentially around at least a portion of the diameter of the capsule.

11. The delivery system of claim 10, wherein the protrusion defines a ring shape and extends around an entirety of the diameter of the capsule.

12. The system of claim 1, wherein the protrusion includes a plurality of longitudinally extending ridges protruding from the outer surface of the capsule.

13. The delivery system of claim 12, wherein the plurality of longitudinally extending ridges includes at least 6 ridges.

14. The delivery system of claim 12, wherein the capsule has an extruded cross-section and wherein the longitudinally extending ridges have an angular cross-sectional shape.

15. The delivery system of claim 14, wherein the longitudinally extending ridges have a rectangular cross-sectional shape.

16. The delivery system of claim 12, wherein the longitudinally extending ridges extend around a circumference of the capsule, are spaced from each other in a circumferential direction and define troughs between each pair of longitudinally extending ridges.

17. A delivery system for delivering a stent mounted heart valve through an expandable sheath, the delivery system comprising:

an elongate catheter having proximal and distal ends, the stent mounted heart valve crimped at the distal end of the catheter;

a capsule sized and configured to extend around and enclose the crimped stent mounted heart valve, the capsule having a distal end with a capsule diameter, the capsule including a protrusion extending from an outer surface of the capsule and having a protrusion diameter greater than the capsule diameter, the protrusion urging the sheath away from the capsule, thereby reducing an average peak push force resulting from advancement of the capsule through the sheath; and

a nosecone coupled at its proximal end to a distal end of the capsule, the nosecone including a tapered surface having a gradually increasing diameter from a distal end of the nosecone towards the proximal end of the nosecone.

18. The delivery system of claim 17, wherein the proximal end of the nosecone defines a nosecone maximum diameter, where the nosecone maximum diameter is greater than the capsule diameter.

19. The delivery system of claim 18, wherein the nosecone maximum diameter is less than the protrusion diameter.

20. The delivery system of claim 17, further comprising the expandable delivery sheath, the sheath having a central lumen sized and configured to receive the elongate catheter, capsule and nosecone, wherein the central lumen defines a starting inner diameter less than the capsule diameter.