Expandable sheath

Patent metadata

Field	Value
Publication number	US-2026090902-A1
Application number	US-202519411015-A
Country	US
Kind code	A1
Filing date	Dec 5, 2025
Priority date	Apr 9, 2018
Publication date	Apr 2, 2026
Grant date	—

Abstract

An expandable sheath is disclosed herein, which has a first polymeric layer and a braided layer positioned radially outward of the first polymeric layer. The braided layer includes a plurality of filaments braided together. The expandable sheaths further include a resilient elastic layer positioned radially outward of the braided layer. The elastic layer is configured to apply radial force to the braided layer and the first polymeric layer. The expandable sheath further includes a second polymeric layer positioned radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers. Methods of making and using the devices disclosed herein are also disclosed, as are crimping devices that may be used in methods of making the devices disclosed herein.

First claim

1 . An expandable sheath for deploying a medical device, comprising:
a first polymeric layer; a braided layer radially outward of the first polymeric layer, the braided layer comprising a plurality of filaments braided together; a second polymeric layer disposed radially outward of the braided layer and bonded to the first polymeric layer such that the braided layer is encapsulated between the first and second polymeric layers; wherein the sheath is movable from a first diameter to a second greater diameter in response to an outwardly directed radial force on a central lumen of the sheath, and resiliently returns toward the first diameter by removal of the radial force, wherein the first and second polymeric layers comprise a plurality of longitudinally-extending folds when the sheath is at the first diameter, the plurality of longitudinally-extending folds creating a plurality of circumferentially spaced ridges and a plurality of circumferentially spaced valleys.

2 . The expandable sheath of claim 1 , wherein, as the sheath is moved toward the second diameter, the plurality of circumferentially spaced ridges and plurality of circumferentially spaced valleys level out to allow the sheath to radially expand.

3 . The expandable sheath of claim 2 , wherein, as the sheath is moved toward the first diameter, the plurality of circumferentially spaced ridges and plurality of circumferentially spaced valleys reform.

4 . The expandable sheath of claim 1 , wherein each of the plurality of circumferentially spaced ridges are spaced apart from each other by a corresponding one of the plurality of circumferentially spaced valleys.

5 . The expandable sheath of claim 1 , wherein the plurality of longitudinally-extending folds extend to a distal end portion of the sheath, the distal end portion extends between a distal end of the sheath and a layered portion of the sheath including the first polymeric layer, braided layer, and second polymeric layer.

6 . The expandable sheath of claim 1 , wherein the filaments of the braided layer are resiliently buckled when the sheath is at the first diameter.

7 . The expandable sheath of claim 1 , wherein the plurality of filaments of the braided layer are movable between the first and second polymeric layers to allow the braided layer to radially expand toward the second diameter.

8 . The expandable sheath of claim 1 , wherein the filaments of the braided layer are not engaged or adhered to the first or second polymeric layers.

9 . The expandable sheath of claim 1 , further comprising:
a resilient elastic layer radially outward of the braided layer, the elastic layer configured to apply radially inward force to the braided layer and the first polymeric layer.

10 . The expandable sheath of claim 9 , wherein the elastic layer comprises one or more elastic bands helically wound over the braided layer.

11 . The expandable sheath of claim 9 , wherein the elastic layer comprises two elastic bands wound with opposite helicity.

12 . The expandable sheath of claim 1 , further comprising:
a distal end portion resiliently expandable between the first diameter and a second diameter; a vessel dilator disposed within the sheath, the vessel dilator comprising a tapered nose cone and a retaining member that extends at least partially over the distal end portion of the sheath and is configured to retain the distal end portion of the sheath at the first diameter.

13 . The expandable sheath of claim 12 , wherein the retaining member is a polymeric heatshrink layer.

14 . The expandable sheath of claim 12 , wherein the retaining member is elastomeric and configured to compress the distal end portion of the sheath.

15 . The expandable sheath of claim 12 , wherein the retaining member is glued or fused to the sheath.

16 . The expandable sheath of claim 12 , wherein the retaining member comprises a shaft disposed between the dilator and the sheath, the shaft comprising a releasable coupling that mechanically engages both the dilator and the sheath and is configured to be manually deactivated.

17 . The expandable sheath of claim 12 , wherein the retaining member comprises one or more balloons disposed between the dilator and the sheath.

18 . A method of making an expandable sheath, the method comprising:
placing a braided layer radially outward of a first polymeric layer situated on a mandrel, the braided layer comprising a plurality of filaments braided together, the mandrel having a first diameter; applying a second polymeric layer radially outward of the braided layer; applying heat and pressure to the first polymeric layer, the braided layer, and the second polymeric layer such that the first and second polymeric layers bond to each other and encapsulate the braided layer to form an expandable sheath; and removing the expandable sheath from the mandrel to allow the expandable sheath to at least partially radially collapse to a second diameter that is less than the first diameter.

19 . The method of claim 18 , comprising applying an elastic layer radially outward of the braided layer before applying the second polymeric layer, the elastic layer being configured to apply radial force to the first polymeric layer and the braided layer, where applying the elastic layer comprises wrapping one or more elastic bands around the braided layer,
wherein applying heat and pressure includes applying heat and pressure to the first polymeric layer, the braided layer, the elastic layer, and the second polymeric layer such that the first and second polymeric layers bond to each other and encapsulate the braided layer and the elastic layer to form an expandable sheath, and wherein removing the expandable sheath from the mandrel allows the expandable sheath to at least partially radially collapse to the second diameter under radial force applied by the elastic layer.

20 . The method of claim 19 , wherein after application of the braided layer, the method further comprises removing the first polymeric layer and the braided layer from the mandrel, applying the elastic layer in a relaxed or a moderately stretched state, and placing the first polymeric layer, the braided layer, and the elastic layer back on the mandrel to stretch the elastic layer prior to application of the second polymeric layer.

Assignees

• Edwards Lifesciences Corp

Inventors

• Goldberg Eran
• Axelrod Manela Noa
• Neumann Yair A
• Manash Boaz
• Maimon David
• Leiba Eyal
• Schneider Ralph
• Tayeb Liron

Classifications

• A61F2/9526

  using a mandrel · CPC title

• A61F2002/9623

  the sleeve being reinforced · CPC title

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title

• A61M2025/0024

  Expandable catheters or sheaths · CPC title