Kink resistant peel away sheath

Patent metadata

Field	Value
Publication number	US-12083296-B2
Application number	US-201916707923-A
Country	US
Kind code	B2
Filing date	Dec 9, 2019
Priority date	Dec 10, 2018
Publication date	Sep 10, 2024
Grant date	Sep 10, 2024

Abstract

Devices and methods for providing a kink resistant peel away sheath are disclosed. One device includes a sheath for insertion into a vasculature of a patient. The sheath comprises a sheath body having an outer surface, a longitudinal axis and a lumen formed therethrough. The sheath body comprises an inner layer arranged about the longitudinal axis, an outer layer coaxially arranged with the inner layer, and a support layer positioned between the inner and outer layers, wherein the inner, outer and support layers are laminated together to form the sheath body. The sheath also comprises at least one shear line positioned beneath the outer surface of the sheath body, and configured to facilitate the longitudinal separation of the sheath body along the at least one shear line.

First claim

The invention claimed is:

1. A sheath for insertion into a vasculature of a patient, the sheath comprising:
a sheath body having an outer surface, a longitudinal axis and a lumen formed therethrough, the sheath body comprising an inner layer arranged about the longitudinal axis, an outer layer coaxially arranged with the inner layer, and a support layer positioned between the inner and outer layers, wherein the inner, outer and support layers are laminated together to form the sheath body; and
at least one shear line formed in the sheath body, the at least one shear line configured to facilitate the longitudinal separation of the sheath body along the at least one shear line,
wherein each of the at least one shear line is defined by a monofilament positioned between the support layer and outer layer, before the inner, outer, and support layers are laminated together such that the at least one shear line, as formed, is positioned beneath the outer surface of the sheath body and within the outer layer.

2. The sheath of claim 1 , wherein the inner and outer layers comprise extrusions.

3. The sheath of claim 1 , wherein the inner and outer layers are fabricated from at least one of: a polyether block amide, a polyethylene material, a polytetrafluoroethylene (PTFE) material, a high-density polyethylene (HDPE) material, a medium-density polyethylene (MDPE) material, or a low-density polyethylene (LDPE) material.

4. The sheath of claim 1 , wherein the at least one shear line is any one of linear or non-linear.

5. The sheath of claim 1 , wherein the monofilament is positioned on an outer surface of the support layer and between the support and outer layers.

6. The sheath of claim 5 , wherein the monofilament extends longitudinally along the sheath body.

7. The sheath of claim 5 , wherein the monofilament helically extends along the longitudinal axis.

8. The sheath of claim 5 , wherein the monofilament comprises a rod fabricated from at least one of: polyether ether ketone (PEEK), a polyether block amide, a polyethylene material, a polytetrafluoroethylene (PTFE) material, a nylon, a high-density polyethylene (HDPE) material, a medium-density polyethylene (MDPE) material, a low-density polyethylene (LDPE) material, or stainless steel.

9. The sheath of claim 5 , wherein the monofilament is fused with the support layer.

10. The sheath of claim 5 , wherein there is a void between the monofilament and the outer layer.

11. The sheath of claim 5 , wherein the monofilament is removable from the sheath body.

12. The sheath of claim 1 , wherein the at least one shear line comprises a first shear line and a second shear line.

13. The sheath of claim 12 , wherein
the first and second shear lines are respectively defined by first and second monofilaments that are each positioned between the support and outer layers, and
the first and second monofilaments are radially separated 180° about the longitudinal axis.

14. The sheath of claim 1 , wherein the support layer comprises a braid or a coil.

15. The sheath of claim 1 , wherein the support layer comprises a spiral laser cut layer.

16. The sheath of claim 15 , wherein the sheath body is pre-scored along the shear line.

17. The sheath of claim 1 , wherein the support layer comprises at least one S-shaped wire having turns that are held in an interlocked orientation by a removable mandrel.

18. The sheath of claim 1 , wherein the support layer comprises a plurality of S-shaped wires that are held in an interlocked orientation by a corresponding number of removable mandrels.

19. The sheath of claim 1 , wherein the at least one shear line extends longitudinally along at least a portion of the length of the sheath body.

20. The sheath of claim 1 , wherein the at least one shear line comprises any one of: a void, a frangible seam, or a frangible connection, formed within the sheath body.

21. The sheath of any of claim 1 , wherein the support layer is fabricated from at least one of: polyether ether ketone (PEEK), a polyether block amide, a polyethylene material, a polytetrafluoroethylene (PTFE) material, a nylon, a high-density polyethylene (HDPE) material, a medium-density polyethylene (MDPE) material, a low-density polyethylene (LDPE) material, or stainless steel.

22. A method of using the sheath according to claim 1 for treating a patient with a ventricular assist device, the method comprising the steps of:
inserting the sheath into the arteriotomy of the patient at a first position;
inserting the ventricular assist device through the sheath and into the arteriotomy of the patient at the first position; and
separating the sheath by peeling away the sheath body.

Assignees

• Abiomed Inc

Inventors

• Liu Clifford M

Classifications

• A61M25/0045 Primary

  multi-layered, e.g. coated (coating materials A61L29/08) · CPC title

• A61M2025/0188

  having slitted or breakaway lumens · CPC title

• A61M60/865

  Devices for guiding or inserting pumps or pumping devices into the patient's body · CPC title

• A61M2025/0059

  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 title

• A61M2025/0675

  Introducing-sheath slitters · CPC title