Expandable introducer sheath

Patent metadata

Field	Value
Publication number	US-11517432-B2
Application number	US-202016822658-A
Country	US
Kind code	B2
Filing date	Mar 18, 2020
Priority date	Mar 31, 2016
Publication date	Dec 6, 2022
Grant date	Dec 6, 2022

Abstract

An expandable introducer sheath provided with a steering mechanism is disclosed. The introducer sheath is configured for providing a prosthesis delivery system percutaneous access to a patient's vasculature. The introducer sheath includes a sheath component defining a central lumen and having a longitudinally-extending, radially-expandable portion. The sheath component also includes a steering wire slidably disposed within a wall thereof that longitudinally extends along the radially-expandable portion. When the steering wire is in a slackened configuration, the steering wire permits a width of the radially-expandable portion to increase. When the steering wire is in a taut configuration, the steering wire permits a distal portion of the sheath component to be manipulated or bent in order to align a distal port of the introducer sheath, for instance, with an ostium of a branch vessel.

First claim

What is claimed is:

1. An introducer sheath for providing a prosthesis delivery system percutaneous access to a patient's vasculature, the sheath comprising:
a sheath component having a central lumen defined by a wall structure thereof, the wall structure formed from
a circumferentially continuous inner layer with a radially-expandable portion, and
a circumferentially discontinuous outermost layer that is connected to the circumferentially continuous inner layer, the circumferentially discontinuous outermost layer including first and second longitudinally-extending edges between which the radially-expandable portion of the inner layer is defined; and

a C-shaped wire structure embedded within the circumferentially discontinuous outermost layer of the wall structure for providing kink resistance and reinforcement to the sheath component,
wherein the radially-expandable portion of the circumferentially continuous inner layer is disposed inwardly of the first and second longitudinally-extending edges of the circumferentially discontinuous outermost layer in each of an unexpanded state of the sheath component in which no portion of the sheath component is expanded and an expanded state of the sheath component, and
wherein in both the unexpanded state and the expanded state of the sheath component the first and second longitudinally-extending edges of the circumferentially discontinuous outermost layer are non-overlapping.

2. The introducer sheath of claim 1 , wherein a first distance is defined between the first and second longitudinally-extending edges of the circumferentially discontinuous outermost layer of the wall structure when the sheath component is in the unexpanded state, and
wherein a second distance, greater than the first distance, is defined between the first and second longitudinally-extending edges of the circumferentially discontinuous outermost layer of the wall structure when the sheath component is in the expanded state.

3. The introducer sheath of claim 1 , wherein the radially-expandable portion of the circumferentially continuous inner layer of the wall structure has a first width when the sheath component is in the unexpanded state, and
wherein the radially-expandable portion of the circumferentially continuous inner layer of the wall structure has a second width, greater than the first width, when the sheath component is in the expanded state.

4. The introducer sheath of claim 3 , wherein the central lumen of the sheath component has a first diameter when the radially-expandable portion of the circumferentially continuous inner layer of the wall structure has the first width, and
wherein the central lumen of the sheath component has a second diameter, greater than the first diameter, when the radially-expandable portion of the circumferentially continuous inner layer of the wall structure has the second width.

5. The introducer sheath of claim 4 , wherein the central lumen of the sheath component expands from the first diameter to the second diameter when at least a distal portion of the prosthesis delivery system is passed therethrough.

6. The introducer sheath of claim 1 , wherein the C-shaped wire structure is formed from a shape-memory or resilient material to return the sheath component from the expanded state to the unexpanded state.

7. An introducer sheath for providing a prosthesis delivery system percutaneous access to a patient's vasculature comprising:
a sheath component having a wall structure formed from
an inner liner with a radially-expandable portion, the radially-expandable portion having a first width when the sheath component is in an unexpanded state and a second width, greater than the first width, when the sheath component is in an expanded state, wherein the first width is a smallest width of the radially-expandable portion, and
an outermost jacket that is connected to the inner liner, the outermost jacket including first and second longitudinally-extending edges between which the radially-expandable portion of the inner liner extends; and

a C-shaped wire structure embedded within the outermost jacket of the wall structure for providing kink resistance and reinforcement to the sheath component,
wherein the radially-expandable portion of the inner liner is disposed inwardly of the first and second longitudinally-extending edges of the outermost jacket in each of the unexpanded state and the expanded state of the sheath component; and
wherein in both the unexpanded state and the expanded state of the sheath component the first and second longitudinally-extending edges of the outermost jacket are non-overlapping.

8. The introducer sheath of claim 7 , wherein a central lumen of the sheath component has a first diameter when the radially-expandable portion of the inner liner of the wall structure has the first width, and
wherein the central lumen of the sheath component has a second diameter, greater than the first diameter, when the radially-expandable portion of the inner liner of the wall structure has the second width.

9. The introducer sheath of claim 8 , wherein the central lumen of the sheath component expands from the first diameter to the second diameter when at least a distal portion of the prosthesis delivery system is passed therethrough.

10. The introducer sheath of claim 7 , wherein a first distance is defined between the first and second longitudinally-extending edges of the outermost jacket of the wall structure when the sheath component is in the unexpanded state, and
wherein a second distance, greater than the first distance, is defined between the first and second longitudinally-extending edges of the outermost jacket of the wall structure when the sheath component is in the expanded state.

11. The introducer sheath of claim 7 , wherein the C-shaped wire structure is formed from a shape-memory or resilient material to return the sheath component from the expanded state to the unexpanded state.

12. The introducer sheath of claim 7 , wherein the inner liner forms a circumferentially continuous inner layer.

13. The introducer sheath of claim 12 , wherein the outermost jacket forms a circumferentially discontinuous outermost layer.

Assignees

• Medtronic Vascular Inc

Inventors

• Costello Declan

Classifications

• A61M2025/0024

  Expandable catheters or sheaths · CPC title

• A61M2025/0047

  the inner layer having a higher lubricity · CPC title

• A61M25/0662

  Guide tubes · CPC title

• A61M25/0147

  with movable mechanical means, e.g. pull wires · CPC title

• A61M25/0133

  Tip steering devices · CPC title