Expandable sheath and methods of using the same

• US 10,639,152 B2
• Filed: 06/18/2018
• Issued: 05/05/2020
• Est. Priority Date: 06/21/2017
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Le, Thanh Huy, Le, Tung T., Mak, Sovanpheap, Gowdar, Alpana Kiran, White, Richard D., Tran, Sonny
• Primary Examiner(s): Schwiker, Katherine H
• Assistant Examiner(s): Amechi, Alexis D
• Application Number:
  US16/010,744
• Publication Number:
  US 20180368979A1
• Time in Patent Office: 687 Days
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2039/0626 used with other surgical instruments, e.g. endoscope, trocar
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: B29C 65/00 Joining or sealing of preformed parts , e.g. welding of plastics materials; Apparatus therefor general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326
• CPC Class Codes: B29D 23/00 Producing tubular articles B29D24/00 takes precedence

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 an implant, then return to a non-expanded state after the passage of the device. The sheath includes a foldable inner member having a detached flap structure at its distal tip that facilitates expansion of the sheath lumen to increased diameters, and an elastomeric distal end that reduces push and retrieval forces therethrough. The sheath can include a hemostasis seal on its proximal end to prevent the leakage of blood out of the sheath and prevent ballooning of outer layer of the sheath.

Claims

1. An expandable sheath comprising:

an elongated inner member including at least one foldable axial portion;

an outer elastomeric member extending at least partially over the elongated inner member and configured to exert a compressive force onto the elongated inner member to bias the at least one foldable axial portion into a folded configuration; and

a proximal seal including a middle member extending from an outer surface of the elongated inner member to an inner surface of the outer elastomeric member, the proximal seal configured to guard against proximal migration of fluid from a distal free end of the expandable sheath to a proximal end of the expandable sheath;

wherein the elongated inner member defines a central lumen, a first circumferential portion including first and second longitudinal edges, and a second circumferential portion extending between the first and second longitudinal edges;

wherein the elongated inner member is configured to crease at the first and second longitudinal edges into the folded configuration such that the first and second longitudinal edges overlap, wherein the second circumferential portion is positioned at least partially between the first and second longitudinal edges when overlapped;

wherein the elongated inner member further includes a distal tip, the distal tip including a flap extending from the first longitudinal edge and at least to the second longitudinal edge in an open configuration of the elongated inner member.

2. The expandable sheath of claim 1, wherein the elongated inner member and outer elastomeric member have an unconnected length distal to the proximal seal.

3. The expandable sheath of claim 2, wherein the unconnected length extends distally from the proximal seal to the distal free end of the expandable sheath.

4. The expandable sheath of claim 3, wherein the proximal seal is configured to block a path starting at the distal free end and extending proximally to the proximal seal.

5. The expandable sheath of claim 1, further comprising an outer jacket extending over the outer elastomeric member at the proximal seal.

6. The expandable sheath of claim 1, wherein the outer elastomeric member is fused to the elongated inner member at the proximal seal.

7. The expandable sheath of claim 6, wherein the outer elastomeric member is foldable at the proximal seal along with the elongated inner member.

8. The expandable sheath of claim 7, wherein the elongated inner member is foldable independent of the outer elastomeric member distal to the proximal seal.

9. The expandable sheath of claim 8, wherein the elongated inner member is configured to at least partially unfold to an open configuration for passage of an implant.

10. The expandable sheath of claim 1, further comprising a strain relief portion extending distally from the proximal end of the expandable sheath and wherein the proximal seal has a proximal end adjacent a distal end of the strain relief portion.

11. An expandable sheath comprising:

an elongated inner member defining a central lumen, a first circumferential portion including a first and a second longitudinal edge, and a second circumferential portion extending between the first and second longitudinal edges,

wherein the elongated inner member is configured to crease at the first and second longitudinal edges into a folded configuration such that the first and second longitudinal edges overlap, wherein the second circumferential portion is positioned at least partially between the first and second longitudinal edges when overlapped; and

an outer elastomeric member extending around the elongated inner member and configured to bias the elongated inner member into the folded configuration;

wherein the elongated inner member further includes a distal tip, the distal tip including a flap extending from the first longitudinal edge and at least to the second longitudinal edge in an open configuration of the elongated inner member.

12. The expandable sheath of claim 11, wherein the flap is configured to slide circumferentially over an outer surface of the first circumferential portion when the elongated inner member is biased into the folded configuration by the outer elastomeric member.

13. The expandable sheath of claim 11, wherein the second circumferential portion has a distal edge extending longitudinally at least to a proximal edge of the flap.

14. The expandable sheath of claim 13, wherein the proximal edge of the flap extends over the distal edge of the second circumferential portion onto an outer surface of the second circumferential portion.

15. The expandable sheath of claim 11, wherein the flap includes a longitudinal section of the second circumferential portion cut along the second longitudinal edge.

16. The expandable sheath of claim 15, wherein the longitudinal section is also cut circumferentially from a distal end of the second circumferential portion.

17. The expandable sheath of claim 15, wherein the flap further includes an overlap extension that extends circumferentially from the longitudinal section.

18. The expandable sheath of claim 17, wherein the overlap extension extends proximally from the longitudinal section.

19. The expandable sheath of claim 11, wherein the distal tip further comprises an elastomeric end extending from a distal end of the elongated inner member.

20. The expandable sheath of claim 19, wherein the elastomeric end has a distally tapering shape.

21. The expandable sheath of claim 11, further comprising a marker embedded in the distal tip of the elongate inner member.