Implant delivery capsule

• US 10,350,067 B2
• Filed: 10/21/2016
• Issued: 07/16/2019
• Est. Priority Date: 10/26/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Patel, Darshin S.
• Primary Examiner(s): Dang, Phong Son H
• Application Number:
  US15/331,564
• Publication Number:
  US 20170112624A1
• Time in Patent Office: 998 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 a crimped or collapsed condition. The delivery system also includes a nosecone with a tapered distal end and a proximal end enlarged to have a diameter larger than the capsule. Surprisingly, the proximal end of the nosecone, despite having a larger profile than the capsule, reduces an average peak push force for advancing the delivery system through an introducer sheath. Also disclosed are features, such as protrusions and ridges, supported on an outside of the capsule for reducing push force.

Claims

1. A delivery system for delivering a stent mounted heart valve into a patient vessel, the delivery system comprising:

an expandable sheath;

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

a capsule coupled to the distal end of the elongate catheter, the capsule sized and configured to extend around and enclose the stent mounted heart valve, the capsule having a distal end defining a capsule diameter;

a nosecone including a tapered distal end and a proximal end, the proximal end engaged to the distal end of the capsule, wherein the tapered distal end has a smooth continuous shape configured to progressively urge the sheath outward and the proximal end defines a nosecone maximum diameter greater than the capsule diameter, and

wherein the expandable sheath has 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, and

wherein the nosecone reduces an average peak push force resulting from advancement of the capsule through the expandable sheath.

2. The delivery system of claim 1, further comprising 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 the nosecone maximum diameter is at least 1.002 times the capsule diameter.

4. The delivery system of claim 3, wherein an upper tolerance limit of the peak push force is less than 40 Newtons.

5. The delivery system of claim 3, wherein an upper tolerance limit of the peak push force is less than 33 Newtons.

6. The delivery system of claim 3, wherein the nosecone maximum diameter is 1.002 times to 1.045 times the capsule diameter.

7. The delivery system of claim 1, wherein the nosecone includes a progressive expansion portion, a rounded portion and an inflection point.

8. The delivery system of claim 7, wherein the nosecone maximum diameter corresponds with the inflection point.

9. The delivery system of claim 8, wherein the progressive expansion portion is on a distal end of the nosecone, the rounded portion is adjacent and proximal the progressive expansion portion, and the inflection point is proximal the rounded portion.

10. The delivery system of claim 9, wherein the nosecone further includes a proximal end proximal the inflection point and having a shrinking diameter relative to the maximum diameter.

11. A delivery system for delivering a stent mounted heart valve through an expandable sheath and into a patient vessel, the delivery system comprising:

an expandable sheath, wherein the expandable 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

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

a capsule coupled to the distal end of the elongate catheter, the capsule sized and configured to extend around and enclose the stent mounted heart valve, the capsule having a distal end defining a capsule diameter;

a nosecone including a distal end, a proximal end, and an inflection portion therebetween comprising an inflection point, the proximal end of the nosecone engaged to the distal end of the capsule, wherein the distal end of the nosecone has a gradually increasing diameter from a distalmost end to the inflection portion and has a smooth continuous shape configured to progressively urge the sheath outward, the inflection point has a diameter greater than a diameter of the proximal end adjacent the capsule, wherein the diameter of the proximal end adjacent the capsule is greater than the capsule diameter and the inflection portion has a continuously rounded profile, and

wherein the nosecone reduces an average peak push force resulting from advancement of the capsule through an expandable sheath.

12. The delivery system of claim 11, further comprising 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.

13. The delivery system of claim 11, wherein the inflection point defines a nosecone maximum diameter and the nosecone maximum diameter is at least 1.002 times the capsule diameter.

14. The delivery system of claim 13, wherein an upper tolerance limit of the peak push force is less than 40 Newtons.

15. The delivery system of claim 13, wherein an upper tolerance limit of the peak push force is less than 33 Newtons.

16. The delivery system of claim 13, wherein the nosecone maximum diameter is 1.002 times to 1.045 times the capsule diameter.

17. The delivery system of claim 11, wherein the proximal end proximal the inflection point has a shrinking diameter relative to the diameter of the inflection point.