Expandable sheath

Patent metadata

Field	Value
Publication number	US-12090282-B2
Application number	US-202117170354-A
Country	US
Kind code	B2
Filing date	Feb 8, 2021
Priority date	Jan 23, 2017
Publication date	Sep 17, 2024
Grant date	Sep 17, 2024

Abstract

Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for a cardiovascular device, then return to a non-expanded state after the passage of the device. The sheath includes an elongated annular member having longitudinally extending channels that facilitate the sheath's temporary expansion. The channels are positioned in such a way that, upon expansion, they enable the movement of protruding contact surfaces toward the inner and outer surfaces of the annular member, reducing friction between the surface and the passing device. Some embodiments of the expandable sheath include an elastic outer layer that pushes the protruding contact surfaces back towards their original positions after the passage of the device.

First claim

What is claimed is:

1. A method of making an expandable sheath, the method comprising:
extruding a first tube comprising a first material, the first material defining an elongated annular member, the elongated annular member comprising a bridge member extending between a radially inward corner of a first base member and a radially outward corner of a second base member, the second base member positioned circumferentially adjacent to the first base member, the elongated annular member further comprising a first set of longitudinally extending channels extending inwardly from an outer surface of the annular member towards a longitudinal axis of the annular member and a second set of longitudinally extending channels extending outwardly from an inner surface of the annular member away from the longitudinal axis;
coextruding a second material with the first tube, the second material defining a first set of longitudinally extending ribbons extending within the first set of longitudinally extending channels and a second set of longitudinally extending ribbons extending within the second set of longitudinally extending channels; and
covering the annular member with an elastic outer layer.

2. The method of claim 1 , wherein each ribbon of the first set of longitudinally extending ribbons is positioned circumferentially between two ribbons of second set of longitudinally extending ribbons.

3. The method of claim 1 , further comprising removing the second material, thereby exposing the first and second sets of longitudinally extending channels.

4. The method of claim 1 , further comprising coextruding a third material in contact with a portion of the first material and a portion of the second material, wherein the third material adheres to the first material, and wherein the third material adheres to the second material.

5. The method of claim 4 , wherein the third material is located between a portion of the first and second material within the first and second set of channels.

6. The method of claim 1 , wherein extruding the first tube further comprises widening a diameter of one end of the first tube.

7. The method of claim 1 , wherein the annular member comprises a plurality of base members and a plurality of bridge members, wherein each base member of the plurality of base members is spaced from an adjacent base member of the plurality of base members by a bridge member of the plurality of bridge members.

8. The method of claim 7 , wherein at least one base member of the plurality of base members defines a rectilinear shape in cross section.

9. The method of claim 1 , wherein the elastic outer layer has a lower lubricity than the annular member.

10. A method of making an expandable sheath, the method comprising:
extruding a first tube comprising a first material, the first material defining an elongated annular member, the elongated annular member comprising a bridge member extending between a radially inward corner of a first base member and a radially outward corner of a second base member, the second base member positioned circumferentially adjacent to the first base member;
covering the annular member with an elastic outer layer; and
making a distal tip of the expandable sheath by:
attaching a second tube to the distal end of the first tube;
pinching a portion of a distal end of the second tube to create a longitudinally extending outer crease;
folding the pinched portion over an outer surface of the distal end of the second tube in a circumferential direction to create a longitudinally extending flap bounded by the outer crease and a longitudinally extending inner crease;
forming a longitudinal cut at the inner crease of the longitudinally extending flap in a longitudinal direction from a distal edge of the second tube to a proximally spaced point along the longitudinal axis of the second tube, thereby creating a longitudinally extending inner edge;
cutting the longitudinally extending flap at the proximally spaced point in a circumferential direction from the outer crease to the longitudinal cut at the inner crease;
extending the inner edge of the longitudinally extending flap in a circumferential direction around the outer surface of the distal end of the second tube; and
adhering the inner edge of the longitudinally extending flap to the outer surface of the distal end of the second tube to create the distal tip.

11. The method of claim 10 , wherein the annular member has a first set of longitudinally extending channels extending inwardly from an outer surface of the annular member towards a longitudinal axis of the annular member and a second set of longitudinally extending channels extending outwardly from an inner surface of the annular member away from the longitudinal axis, and wherein the first tube is coextruded with a second material, the second material defining a first set of longitudinally extending ribbons extending within the first set of longitudinally extending channels and a second set of longitudinally extending ribbons extending within the second set of longitudinally extending channels.

12. The method of claim 11 , wherein each ribbon of the first set of longitudinally extending ribbons is positioned circumferentially between two ribbons of second set of longitudinally extending ribbons.

13. The method of claim 11 , further comprising removing the second material, thereby exposing the first and second sets of longitudinally extending channels.

14. The method of claim 11 , further comprising coextruding a third material in contact with a portion of the first material and a portion of the second material, wherein the third material adheres to the first material, and wherein the third material adheres to the second material.

15. The method of claim 14 , wherein the third material is located between a portion of the first and second material within the first and second set of channels.

16. The method of claim 10 , wherein extruding the first tube further comprises widening a diameter of one end of the first tube.

17. The method of claim 10 , wherein the annular member comprises a plurality of base members and a plurality of bridge members, wherein each base member of the plurality of base members is spaced from an adjacent base member of the plurality of base members by a bridge member of the plurality of bridge members.

18. The method of claim 17 , wherein at least one base member of the plurality of base members defines a rectilinear shape in cross section.

19. The method of claim 10 , wherein the elastic outer layer has a lower lubricity than the annular member.

Assignees

• Edwards Lifesciences Corp

Inventors

• Bulman Erik
• Zhou Pu

Classifications

• A61M2207/00

  Methods of manufacture, assembly or production · CPC title

• A61M25/0067

  characterised by the distal end, e.g. tips (A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10) · CPC title

• A61M25/0009

  Making of catheters or other medical or surgical tubes · CPC title

• B29C48/09

  Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels · CPC title

• A61M25/001

  Forming the tip of a catheter, e.g. bevelling process, join or taper · CPC title