Containment vessel with implant sheathing guide

• US 10,245,136 B2
• Filed: 04/27/2017
• Issued: 04/02/2019
• Est. Priority Date: 05/13/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Ino, Takashi H., Gamarra, Randy S., Calomeni, Michael P., Ledesma, Christopher W., Fitterer, Mimi Trinh
• Primary Examiner(s): Gehman, Bryon
• Application Number:
  US15/498,807
• Publication Number:
  US 20170325928A1
• Time in Patent Office: 705 Days
• Field of Search: 206363, 206364, 206438, 623 21, 623 211
• CPC Class Codes: A61B 2017/3464 with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• 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

Abstract

A containment vessel for storing and rinsing a medical implant coupled to a delivery system having an outer sheath may include a hollow element having a wall, a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the lumen of the hollow element being configured and adapted to contain a medical implant in a partially-deployed configuration during storage and rinsing of the medical implant and a proximal end cap including a secondary proximal end cap removably secured to the proximal end cap and configured to reversibly seal the proximal end cap to the outer sheath, thereby establishing a closed fluid connection between the lumen of the hollow element and a lumen of the outer sheath. The proximal end cap may include a sheathing guide configured and adapted to direct the medical implant into the lumen of the outer sheath.

Claims

1. A containment vessel for storing and sterilizing a medical implant coupled to a delivery system having an outer sheath, the containment vessel comprising:

a hollow element having a wall, a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the lumen of the hollow element being configured and adapted to contain a medical implant in a partially-deployed configuration during storage and sterilizing of the medical implant; and

a proximal end cap including a secondary proximal end cap removably secured thereto and configured to reversibly seal the proximal end cap to the outer sheath, whereupon a closed fluid connection is established between the lumen of the hollow element and a lumen of the outer sheath;

wherein the proximal end cap includes a sheathing guide configured and adapted to compress and to direct the medical implant into the lumen of the outer sheath.

2. The containment vessel of claim 1, wherein the medical implant is stored within the lumen of the hollow element in a wet condition.

3. The containment vessel of claim 1, wherein the containment vessel for the medical implant includes a distal end cap having an outlet configured to selectively release storage fluid from within the lumen of the hollow element.

4. The containment vessel of claim 3, wherein the storage fluid includes one or more biocidal fluids.

5. The containment vessel of claim 3, wherein the distal end cap includes an outlet configured to selectively release rinsing fluid from within the lumen of the hollow element.

6. The containment vessel of claim 1, wherein the sheathing guide is integrally formed with the proximal end cap.

7. The containment vessel of claim 1, wherein the containment vessel includes a radiopaque sleeve disposed about the lumen of the hollow element.

8. The containment vessel of claim 7, wherein the radiopaque sleeve is disposed about the wall of the hollow element.

9. The containment vessel of claim 7, wherein the radiopaque sleeve is configured to limit exposure of the medical implant to 4 gray or less of ionizing radiation when the medical implant is stored in the lumen of the hollow element and the containment vessel is exposed to 15 gray or more of ionizing radiation.

10. The containment vessel of claim 1, wherein the proximal end cap is threadably secured to the proximal end of the hollow element.

11. The containment vessel of claim 1, wherein the medical implant is a replacement heart valve.

12. The containment vessel of claim 1, wherein the secondary proximal end cap is threadably secured to the proximal end cap.

13. The containment vessel of claim 12, wherein the proximal end cap includes a sealing element disposed therein, the secondary proximal end cap being configured to compress the sealing element against an outer surface of the outer sheath.

14. The containment vessel of claim 1, wherein the proximal end cap includes a sheath receiving portion configured to matingly abut a distal end of the outer sheath.

15. The containment vessel of claim 1, wherein the sheathing guide includes a tapered surface extending from a distal end of the sheathing guide toward a proximal end of the proximal end cap.

16. The containment vessel of claim 15, wherein the tapered surface tapers radially inwardly from the distal end of the sheathing guide toward the proximal end of the proximal end cap.

17. The containment vessel of claim 1, wherein a minimum inner diameter of the sheathing guide is less than an inner diameter of the lumen of the outer sheath at the distal end of the lumen of the outer sheath.

18. An accessory sheathing guide, comprising:

a first portion and a second portion configured to matingly engage with the first portion to define a tapered surface tapering radially inwardly from a distal end of the accessory sheathing guide toward a proximal end of the sheathing guide,

wherein the first portion is coupled to the second portion.

19. The accessory sheathing guide of claim 18, wherein the first portion is pivotably connected to the second portion by a hinge element.

20. An accessory sheathing guide, comprising:

a first portion and a second portion configured to matingly engage with the first portion to define a tapered inner surface tapering from a maximum inner diameter adjacent a distal end of the accessory sheathing guide to a minimum inner diameter adjacent a proximal end of the sheathing guide,

wherein

the first portion is reversibly coupled to the second portion;

wherein the first portion is separable from and independent of the second portion.