Elastic introducer sheath

• US 9,907,931 B2
• Filed: 04/24/2014
• Issued: 03/06/2018
• Est. Priority Date: 10/26/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Birmingham, Evelyn, Duffy, Niall, Elmouelhi, Ahmed M., Griffin, Patrick, Macaulay, Patrick, Milroy, John, Peter, Stephen J.
• Primary Examiner(s): Tanner, Jocelin
• Application Number:
  US14/260,537
• Publication Number:
  US 20140236123A1
• Time in Patent Office: 1,412 Days
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An elastic percutaneous elastic introducer sheath is disclosed which can locally expand and reduce to accommodate a transcatheter medical device. The elastic introducer sheath includes a non-circumferentially continuous elastic frame, a liner, and a jacket.

Claims

1. An elastic surgical access device comprising:

a circumferentially continuous layer of a biocompatible material, the circumferentially continuous layer having an overlap region with at least one fold when the elastic surgical access device is in a collapsed configuration;

an elastic frame; and

a non-circumferentially continuous layer of a biocompatible material connected to the elastic frame and to the circumferentially continuous layer, the non-circumferentially continuous layer having an overlap region when the elastic surgical access device is in the collapsed configuration and a longitudinal gap when the elastic surgical access device is in an expanded configuration,

wherein the respective overlap regions of the circumferentially continuous layer and the non-circumferentially continuous layer are substantially co-extensive when the elastic surgical access device is in the collapsed configuration, and

wherein the at least one fold of the overlap region of the circumferentially continuous layer flattens to extend across the longitudinal gap of the non-circumferentially continuous layer when the elastic surgical access device is in the expanded configuration.

2. The elastic surgical access device of claim 1, wherein the elastic frame is a wire structure that is curved to form a C-shape in a radial direction.

3. The elastic surgical access device of claim 2, wherein the wire structure has a rectangular cross section.

4. The elastic surgical access device of claim 1, wherein the elastic frame extends along a length of the elastic surgical access device.

5. The elastic surgical access device of claim 4, wherein a stiffness of the elastic frame varies along the length of the elastic surgical access device.

6. The elastic surgical access device of claim 4, wherein the elastic frame includes a spine and a plurality of projections extending from the spine, the plurality of projections being axially spaced apart along the length of the elastic surgical access device.

7. The elastic surgical access device of claim 6, wherein each of the plurality of projections is curved to form a C-shape in a radial direction.

8. The elastic surgical access device of claim 6, wherein each of the spine and each of the plurality of projections has a rectangular cross section.

9. The elastic surgical access device of claim 1, wherein the elastic frame has a non-uniform geometry along its length.

10. The elastic surgical access device of claim 9, wherein a thickness of the elastic frame varies along its length.

11. The elastic surgical access device of claim 9, wherein a width of the elastic frame varies along its length.

12. The elastic surgical access device of claim 1, wherein the circumferentially continuous layer has a second overlap region with at least one fold when the elastic surgical access device is in the collapsed configuration and the non-circumferentially continuous layer has a second longitudinal gap when the elastic surgical access device is in the expanded configuration, wherein the at least one fold of the second overlap region of the circumferentially continuous layer flattens to extend across the second longitudinal gap of the non-circumferentially continuous layer when the elastic surgical access device is in the expanded configuration.

13. The elastic surgical access device of claim 1, wherein the elastic frame is a laser cut tube having a plurality of diamond shaped cells.

14. An elastic surgical access device comprising:

a circumferentially continuous layer of a biocompatible material, the circumferentially continuous layer having an overlap region with at least one fold when the elastic surgical access device is in a collapsed configuration;

an elastic frame that includes a spine and a plurality of projections extending from the spine that are curved to form a C-shape in a radial direction, the plurality of projections being axially spaced apart along the length of the elastic surgical access device; and

a non-circumferentially continuous layer of a biocompatible material connected to the elastic frame and to the circumferentially continuous layer, the non-circumferentially continuous layer having a longitudinal gap when the elastic surgical access device is in an expanded configuration, wherein the at least one fold of the overlap region of the circumferentially continuous layer flattens to extend across the longitudinal gap of the non-circumferentially continuous layer when the elastic surgical access device is in the expanded configuration, and

wherein each of the plurality of projections includes a hook projection at a first end of the C-shape and an eye projection at a second end of the C-shape, each hook projection configured to engage a respective eye projection to limit expansion of the elastic surgical access device.

15. A locally expandable surgical access device comprising:

a non-circumferentially continuous layer of a biocompatible material including a longitudinal gap along a length of the locally expandable surgical access device;

a circumferentially continuous layer of a biocompatible material connected to the non-circumferentially continuous layer; and

an elastic frame extending only across the longitudinal gap and connected to the non-circumferentially continuous layer on each side of the longitudinal gap, wherein the elastic frame includes a plurality of wavy segments that are axially spaced apart and are configured to permit expansion of the locally expandable surgical access device from a collapsed configuration to an expanded configuration.

16. The locally expandable surgical access device of claim 15, wherein the longitudinal gap extends between a first edge of the non-circumferentially continuous layer and a second edge of the non-circumferentially continuous layer, and

wherein the plurality of wavy segments of the elastic frame are formed from a continuous structure having a first edge portion that is attached to the first edge of the non-circumferentially continuous layer and a second edge portion that is attached to the second edge of the non-circumferentially continuous layer.

17. The locally expandable surgical access device of claim 15, wherein the circumferentially continuous layer has an overlap region with at least one fold when the locally expandable surgical access device is in a collapsed configuration and the at least one fold of the overlap region of the circumferentially continuous layer flattens to extend across the longitudinal gap of the non-circumferentially continuous layer when the locally expandable surgical access device is in an expanded configuration, and wherein the elastic frame is configured to maintain the locally expandable surgical access device in the collapsed configuration.

18. The locally expandable surgical access device of claim 15, wherein the longitudinal gap extends between a first edge of the non-circumferentially continuous layer and a second edge of the non-circumferentially continuous layer and wherein each of the plurality of wavy segments of the elastic frame is a distinct structure having a first end that is attached to the first edge of the non-circumferentially continuous layer and a second end that is attached to the second edge of the non-circumferentially continuous layer.

19. The locally expandable surgical access device of claim 18, wherein each of the plurality of wavy segments straighten when the locally expandable surgical access device is in the expanded configuration.

20. An elastic surgical access device comprising:

a circumferentially continuous layer of a biocompatible material, the circumferentially continuous layer having an overlap region with at least one fold when the elastic surgical access device is in a collapsed configuration;

a non-circumferentially continuous layer of a biocompatible material connected to the circumferentially continuous layer, the non-circumferentially continuous layer having a longitudinal gap when the elastic surgical access device is in an expanded configuration, wherein the at least one fold of the overlap region of the circumferentially continuous layer flattens to extend across the longitudinal gap of the non-circumferentially continuous layer when the elastic surgical access device is in the expanded configuration; and

a segmented elastic frame disposed between the circumferentially continuous layer and the non-circumferentially continuous layer, the segmented elastic frame including a plurality of distinct projections, not joined to each other, that are axially spaced apart along a length of the elastic surgical access device.