Evertable sheath devices, systems, and methods

• US 10,213,329 B2
• Filed: 08/09/2012
• Issued: 02/26/2019
• Est. Priority Date: 08/12/2011
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Irwin, Craig W., Silverman, James D.
• Primary Examiner(s): Severson, Ryan J
• Assistant Examiner(s): Knauss, Christian
• Application Number:
  US13/571,296
• Publication Number:
  US 20130204345A1
• Time in Patent Office: 2,392 Days
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9526 using a mandrel
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing 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 2002/826 more than one stent being applied sequentially
• CPC Class Codes: Y10T 29/49863 with prestressing of part

Abstract

The present disclosure comprises devices, systems, and methods having an inverted sheath configured to cover, and in some instances constrain, a medical device and to retract through eversion, thus enabling the deployment of medical device at the treatment site. A constraining sheath can evert hydraulically. A constraining sheath can be configured to neck down a medical device to achieve a lower delivery profile. Furthermore, a constraining sheath can comprise a balloon to expand or positionally or structurally adjust a medical device.

Claims

1. A medical device delivery system comprising:

an elongate member having proximal and distal ends;

a medical device having proximal and distal ends; and

an inverted sheath having a delivery profile and a deployment profile, a proximal end and a distal end;

wherein the medical device is located about the distal end of the elongate member with the inverted sheath in the delivery profile disposed about the medical device,

wherein when the inverted sheath is transitioned to the deployment profile, the medical device can be deployed without requiring further eversion of the inverted sheath,

wherein the inverted sheath comprises an inner layer and an outer layer defining a chamber, and

wherein pressurization of the chamber by introducing a fluid into the chamber causes the inverted sheath to evert and causes the transition from the delivery profile to the deployment profile wherein the inverted sheath has an expanded diameter and a shortened length in the deployment profile relative to the delivery profile.

2. The constraining sheath of claim 1, wherein when the inverted sheath transitions to the deployment profile, the inverted sheath is axially displaced.

3. The medical device delivery system of claim 1, wherein the inverted sheath is neckable.

4. The medical device delivery system of claim 1, wherein the inverted sheath is helically-wrapped.

5. The medical device delivery system of claim 4, wherein the inverted sheath has been necked down to the delivery profile to constrain the medical device.

6. The medical device delivery system of claim 4, wherein the inverted sheath comprises a polymeric tape.

7. The medical device delivery system of claim 6, wherein the polymeric tape comprises ePTFE.

8. The medical device delivery system of claim 7, wherein the ePTFE is anisotropic.

9. The medical device delivery system of claim 1, wherein the medical device comprises a collapsed configuration and an expanded configuration.

10. The medical device delivery system of claim 1, wherein the medical device is self-expanding.

11. The medical device delivery system of claim 1, wherein the medical device is selected from the group consisting of stent, stent-grafts, filters, occluders, oncology therapy, valves, pressure flow monitors, indwelling catheters, drug delivery devices and wires related to the transmission of energy.

12. The medical device delivery system of claim 1, wherein the proximal end of the elongate member and the chamber are in fluid communication.

13. The medical device delivery system of claim 1, wherein the inverted sheath further comprises a retracting member.

14. The medical device delivery system of claim 13, wherein the retracting member is selected from the group consisting of a wire, a polymeric tether, and a polymeric tube.

15. The medical device delivery system of claim 1, wherein the inverted sheath comprises a balloon.

16. A medical device delivery system comprising:

an elongate member having proximal and distal ends;

a medical device having proximal and distal ends; and

an inverted sheath having a delivery profile and a deployment profile;

wherein the medical device is located about the distal end of the elongate member with the inverted sheath in the delivery profile disposed about the medical device,

wherein when the inverted sheath is transitioned to the deployment profile, the medical device is completely uncovered,

wherein the inverted sheath comprises an inner layer and an outer layer defining a chamber, and

wherein pressurization of the chamber by introducing a fluid into the chamber causes the inverted sheath to evert and causes the transition from the delivery profile to the deployment profile wherein the inverted sheath has an expanded diameter and a shortened length in the deployment profile relative to the delivery profile.

17. A medical device delivery system comprising:

an elongate member having proximal and distal ends;

a medical device having proximal and distal ends; and

an inverted sheath having a delivery profile and a deployment profile;

wherein the medical device is located about the distal end of the elongate member with the inverted sheath in the delivery profile disposed about the medical device,

wherein when the inverted sheath is transitioned to the deployment profile, the inverted sheath is no longer disposed about the medical device,

wherein the inverted sheath comprises an inner layer and an outer layer defining a chamber, and

wherein pressurization of the chamber by introducing a fluid into the chamber causes the inverted sheath to evert and causes the transition from the delivery profile to the deployment profile wherein the inverted sheath has an expanded diameter and a shortened length in the deployment profile relative to the delivery profile.