Radially expandable introducer sheath

Patent metadata

Field	Value
Publication number	US-11026719-B2
Application number	US-201815979703-A
Country	US
Kind code	B2
Filing date	May 15, 2018
Priority date	May 15, 2017
Publication date	Jun 8, 2021
Grant date	Jun 8, 2021

Abstract

An introducer sheath may include a tubular member comprising an inner layer and an outer layer coaxially disposed about a central longitudinal axis of the introducer sheath, the tubular member being configured to shift between an unexpanded configuration to an expanded configuration. The inner layer may be circumferentially discontinuous along at least a portion of its length. At least a first portion of the inner layer may be configured to move circumferentially relative to the outer layer when shifting between the unexpanded and expanded configurations.

First claim

What is claimed:

1. An introducer sheath, comprising:
a tubular member comprising an inner layer and an outer layer coaxially disposed about a central longitudinal axis of the introducer sheath, the tubular member being configured to shift between an unexpanded configuration to an expanded configuration;
wherein the inner layer is circumferentially discontinuous along at least a portion of its length;
wherein at least a first portion of the inner layer is configured to slide circumferentially relative to the outer layer when shifting between the unexpanded and expanded configurations;
wherein the outer layer is circumferentially continuous along its entire length;
wherein the inner layer is formed from a substantially inelastic material.

2. The introducer sheath of claim 1 , wherein the inner layer includes a plurality of longitudinally-oriented elements.

3. The introducer sheath of claim 2 , wherein the plurality of longitudinally-oriented elements at least partially circumferentially overlap each other in the unexpanded configuration.

4. The introducer sheath of claim 3 , wherein the plurality of longitudinally-oriented elements circumferentially overlap each other less as the tubular member shifts from the unexpanded configuration toward the expanded configuration.

5. The introducer sheath of claim 2 , wherein the plurality of longitudinally-oriented elements is circumferentially spaced apart from each other in the expanded configuration.

6. The introducer sheath of claim 1 , wherein the outer layer is formed from a substantially elastic material.

7. The introducer sheath of claim 1 , further comprising an elastomeric outer sheath disposed about the outer layer of the tubular member.

8. The introducer sheath of claim 7 , wherein the elastomeric outer sheath is disposed against the outer layer of the tubular member.

9. The introducer sheath of claim 1 , wherein the inner layer is secured to the outer layer such that at least a second portion of the inner layer is circumferentially immovable relative to the outer layer.

10. A medical device system, comprising:
a replacement heart valve delivery system; and
an introducer sheath comprising a tubular member comprising an inner layer and an outer layer coaxially disposed about a central longitudinal axis of the introducer sheath, the tubular member being configured to shift between an unexpanded configuration to an expanded configuration;
wherein the inner layer is circumferentially discontinuous along at least a portion of its length;
wherein at least a first portion of the inner layer is configured to slide circumferentially relative to the outer layer when shifting between the unexpanded and expanded configurations;
wherein the outer layer is circumferentially continuous along its entire lengths wherein the inner layer is formed from a substantially inelastic material; wherein the replacement heart valve delivery system is configured to slide within a lumen of the introducer sheath for advancement within a vasculature.

11. The medical device system of claim 10 , wherein the replacement heart valve delivery system includes a replacement heart valve implant.

12. The medical device system of claim 10 , wherein the replacement heart valve delivery system is unexposed to the vasculature while the replacement heart valve delivery system is disposed within the lumen of the introducer sheath.

13. The medical device system of claim 10 , wherein the tubular member is configured to shift toward the expanded configuration as the replacement heart valve delivery system passes through the lumen of the introducer sheath and shift toward the unexpanded configuration when the replacement heart valve delivery system is removed from the lumen of the introducer sheath.

14. A method of delivering a replacement heart valve, comprising:
advancing an introducer sheath through a vasculature to an access site, the introducer sheath including a tubular member comprising an inner layer and an outer layer coaxially disposed about a central longitudinal axis of the introducer sheath;
the tubular member being configured to shift between an unexpanded configuration to an expanded configuration; wherein the inner layer is circumferentially discontinuous along at least a portion of its length; wherein at least a first portion of the inner layer is configured to slide circumferentially relative to the outer layer when shifting between the unexpanded and expanded configurations; wherein the outer layer is circumferentially continuous along its entire lengths wherein the inner layer is formed from a substantially inelastic material;
inserting a replacement heart valve delivery system into a lumen of the introducer sheath;
advancing the replacement heart valve delivery system through the lumen of the introducer sheath to a treatment site;
wherein the introducer sheath radially expands as the replacement heart valve delivery system is advanced through the introducer sheath; and
deploying the replacement heart valve at the treatment site.

15. The method of claim 14 , wherein the outer layer is circumferentially discontinuous along at least a portion of its length.

16. The method of claim 15 , wherein the inner layer and the outer layer overlap such that when the introducer sheath radially expands as the replacement heart valve delivery system is advanced through the introducer sheath, the lumen of the introducer sheath remains circumferentially closed to the vasculature.

17. The method of claim 16 , wherein the inner layer and the outer layer are arranged in opposing clamshell configurations.

Assignees

• Boston Scient Scimed Inc

Inventors

• Thoreson Michael Richmon
• Grovender Adam David
• Solberg Scott
• Raab David
• Gundale Benjamin Philip
• Olson Ross A
• Anderson James M

Classifications

• A61B17/3439 Primary

  with means for changing the inner diameter of the cannula, e.g. expandable (A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662) · CPC title

• A61B2017/00336

  with a protective sleeve, e.g. retractable or slidable · CPC title

• A61M2025/0024

  Expandable catheters or sheaths · CPC title

• A61M25/0662

  Guide tubes · CPC title

• A61M2039/0279

  for introducing medical instruments into the body, e.g. endoscope, surgical tools · CPC title