Expandable introducer sheath having a steering mechanism

• US 10,631,980 B2
• Filed: 03/22/2017
• Issued: 04/28/2020
• Est. Priority Date: 03/31/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Costello, Declan
• Primary Examiner(s): Rosen, Eric J
• Assistant Examiner(s): Restaino, Andrew P.
• Application Number:
  US15/466,098
• Publication Number:
  US 20170281344A1
• Time in Patent Office: 1,133 Days
• Field of Search: 623 211
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0059 having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes

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.

Claims

1. An introducer sheath for providing a prosthesis delivery system percutaneous access to a patient'"'"'s vasculature comprising:

a sheath component having a longitudinally-extending, radially-expandable portion, the sheath component defining a central lumen;

a steering element slidably disposed within the sheath component and positioned such that first and second segments thereof longitudinally extend along the radially-expandable portion, wherein the first segment of the steering element runs in parallel with a first side of the radially-expandable portion and wherein the second segment of the steering element runs in parallel with an opposing second side of the radially-expandable portion, such that the first and second segments of the steering element are parallel to each other, and

wherein in a slackened configuration the steering element permits a width of the radially-expandable portion to increase and wherein in a taut configuration the steering element prevents expansion of the radially-expandable portion and bends a distal portion of the sheath component.

2. The introducer sheath of claim 1, wherein when the width of the radially-expandable portion increases the central lumen of the sheath component is configured to expand from a first diameter to a second diameter.

3. The introducer sheath of claim 2, wherein the central lumen of the sheath component is configured to expand from the first diameter to the second diameter when at least a distal portion of a prosthesis delivery system is passed therethrough.

4. The introducer sheath of claim 1, wherein the steering element wire includes a lateral segment that slidably extends within the sheath component across a distal end of the radially-expandable portion.

5. The introducer sheath of claim 4, wherein a single wire forms the first, second and lateral segments of the steering element.

6. The introducer sheath of claim 4, wherein more than one wire forms the first, second and lateral segments of the steering element.

7. The introducer sheath of claim 4, wherein proximal ends of the first and second segments of the steering element are attached to a handle component attached to a proximal end of the sheath component.

8. The introducer sheath of claim 7, wherein the handle component is configured to manipulate the steering element between the slackened configuration and the taut configuration.

9. The introducer sheath of claim 1, wherein the sheath component includes a plurality of eyelets within at least the distal portion thereof through which the steering element is slidably engaged.

10. The introducer sheath of claim 9, wherein the first and second segments of the steering element include one or more stops that are sized to engage with but not pass through a distal end of a respective eyelet of the plurality of eyelets, wherein the respective eyelet is disposed along the distal portion of the sheath component.

11. The introducer sheath of claim 1, wherein the sheath component includes a C-shaped wire structure embedded within a wall thereof having first and second series of curved portions that align with the radially-expandable portion.

12. The introducer sheath of claim 11, wherein the first and second segments of the steering element include one or more stops that are sized to engage with but not pass through a distal end of a respective curved portion of the first and second series of curved portions, wherein the respective curved portion is disposed along the distal portion of the sheath component.

13. An introducer sheath for providing a prosthesis delivery system percutaneous access to a patient'"'"'s vasculature comprising:

a sheath component formed to have a longitudinally-extending, radially-expandable portion disposed between longitudinally-extending edges of a reinforced portion, the sheath component defining a central lumen;

a steering element slidably disposed within the sheath component and positioned to at least partially extend with the reinforced portion along opposing longitudinally-extending skies of the radially-expandable portion, wherein the steering element includes a first segment that runs in parallel with a first longitudinally-extending side of the radially-expandable portion and a second segment that runs in parallel with an opposing second longitudinally-extending side of the radially-expandable portion, such that the first and second segments of the steering element are parallel to each other, and

wherein in a taut configuration the steering element prevents expansion of the radially-expandable portion and bends a distal portion of the sheath component.

14. The introducer sheath of claim 13, wherein the steering element further includes a lateral segment that slidably extends within the sheath component across a distal end of the radially-expandable portion.

15. The introducer sheath of claim 14, wherein in a slackened configuration the steering element permits expansion of the radially-expandable portion.

16. The introducer sheath of claim 13, wherein when a width of the radially-expandable portion increases the central lumen of the sheath component is configured to expand from a first diameter to a second diameter.

17. The introducer sheath of claim 16, wherein the central lumen of the sheath component is configured to expand from the first diameter to the second diameter when at least a distal portion of a prosthesis delivery system is passed therethrough.