Torqueable steerable sheaths

Patent metadata

Field	Value
Publication number	US-11484690-B2
Application number	US-201815955908-A
Country	US
Kind code	B2
Filing date	Apr 18, 2018
Priority date	Apr 18, 2017
Publication date	Nov 1, 2022
Grant date	Nov 1, 2022

Abstract

A steerable sheath includes an inner liner extending from a proximal end to a distal end of the steerable sheath. The inner liner includes a non-deflectable portion and a deflectable portion. The steerable sheath includes a first pull wire positioned along a first helical path around the circumference of the inner liner from a proximal end to a distal end of the non-deflectable portion of the inner liner and along a first straight path from a proximal end of the deflectable portion to a distal end of the deflectable portion. The steerable sheath includes a second pull wire positioned along a second helical path around the circumference of the inner liner from the proximal end to the distal end of the non-deflectable portion and along a second straight path from the proximal end of the deflectable portion to the distal end of the deflectable portion.

First claim

What is claimed is:

1. A steerable sheath having a proximal end and a distal end, the steerable sheath comprising,
an inner liner having an outer circumference and extending from the proximal end to the distal end of the steerable sheath, the inner liner including:
a non-deflectable portion having a proximal end and a distal end, the non-deflectable portion extending from the proximal end of the steerable sheath toward the distal end of the steerable sheath;
a deflectable portion extending from a proximal end adjacent the distal end of the non-deflectable portion to a distal end at the distal end of the steerable sheath;

a first pull wire positioned along a first helical path around the outer circumference of the inner liner from the proximal end to the distal end of the non-deflectable portion of the inner liner and along a first straight path from the proximal end of the deflectable portion to the distal end of the deflectable portion;
a first polymeric tubular member positioned along the first helical path and enclosing the first pull wire, the first tubular member having an outer layer and an inner layer, the outer layer and the inner layer made of different materials to facilitate attaching the first tubular member to the inner liner along the first helical path; and
a second pull wire positioned along a second helical path around the outer circumference of the inner liner from the proximal end to the distal end of the non-deflectable portion and along a second straight path from the proximal end of the deflectable portion to the distal end of the deflectable portion.

2. The steerable sheath of claim 1 , wherein the first helical path and the second helical path each complete two revolutions around the inner liner from the proximal end to the distal end of the non-deflectable portion.

3. The steerable sheath of claim 1 , wherein the first pull wire and the second pull wire comprise flat wire.

4. The steerable sheath of claim 1 , wherein the first pull wire and the second pull wire are stainless steel pull wires.

5. The steerable sheath of claim 1 , wherein the first helical path is offset from the second helical path by 180 degrees around the outer circumference of the inner liner.

6. The steerable sheath of claim 1 , wherein the first straight path is offset from the second straight path by 180 degrees around the outer circumference of the inner liner.

7. The steerable sheath of claim 1 , further comprising a second polymeric tubular member positioned along the second helical path and enclosing the second pull wire.

8. The steerable sheath of claim 1 , wherein the outer layer of the first polymeric tubular member has a lower melting point than the inner layer of the first polymeric tubular member.

9. The steerable sheath of claim 1 , wherein the outer and inner layers of the first polymeric tubular member are coaxial with the first pull wire.

10. The steerable sheath of claim 1 , wherein the inner layer is positioned between the outer layer and the first pull wire.

11. The steerable sheath of claim 1 , wherein the outer layer is a thermoplastic elastomer, and wherein the inner layer is polytetrafluoroethylene (PTFE).

12. A steerable introducer comprising,
a handle assembly,
a steerable sheath operatively coupled to the handle assembly, the steerable sheath having a proximal end, a distal end, a non-deflectable portion adjacent the proximal end of the steerable sheath, a deflectable portion adjacent the distal end of the steerable sheath, a first pull wire extending from the proximal end to the distal end of the steerable sheath, a first polymeric tubular member enclosing the first pull wire, and a second pull wire extending from the proximal end to the distal end of the steerable sheath, wherein:
the first pull wire is positioned along a first helical path through the non-deflectable portion of the steerable sheath, and along a first straight path through the deflectable portion of the steerable sheath;
the first polymeric tubular member is positioned along the first helical path and includes an outer layer and an inner layer, the outer layer and the inner layer made of different materials to facilitate attaching the first tubular member to the inner liner along the first helical path; and
the second pull wire is positioned along a second helical path through the non-deflectable portion of the steerable sheath, and along a second straight path through the deflectable portion of the steerable sheath.

13. The steerable introducer of claim 12 , wherein the first helical path and the second helical path each complete two revolutions about the steerable sheath from a proximal end to a distal end of the non-deflectable portion.

14. The steerable introducer of claim 12 , wherein the steerable sheath further comprises a second polymeric tubular member positioned along the second helical path and enclosing the second pull wire.

15. The steerable introducer of claim 12 , wherein each of the first pull wire and the second pull wire extends from the proximal end of the steerable sheath and are operatively coupled to the handle assembly.

16. A method of producing a steerable sheath comprising:
positioning a first pull wire along a first helical path around a circumference of a non-deflectable portion of an inner liner from a proximal end of the non-deflectable portion of the inner liner to a distal end of the non-deflectable portion of the inner liner;
positioning the first pull wire along a first straight path from a proximal end of a deflectable portion of the inner liner to a distal end of the deflectable portion, wherein the proximal end of the deflectable portion of the inner liner is adjacent the distal end of the non-deflectable portion of the inner liner;
bonding a first polymeric tubular member to the inner liner along the first helical path by applying hot air to the first polymeric tubular member, the first polymeric tubular member including an outer layer and an inner layer, the outer layer and the inner layer made of different materials;
positioning the first pull wire in the first polymeric tubular member;
positioning a second pull wire along a second helical path around the circumference of the non-deflectable portion of the inner liner from the proximal end of the non-deflectable portion of the inner liner to the distal end of the non-deflectable portion of the inner liner; and
positioning the second pull wire along a second straight path from the proximal end of the deflectable portion of the inner liner to the distal end of the deflectable portion of the inner liner.

17. The method of claim 16 , wherein positioning the first pull wire along the first helical path comprises positioning the first pull wire along the first helical path that completes two revolutions around the circumference of the inner liner between the proximal end of the non-deflection portion and the distal end of the non-deflectable portion, and positioning the second pull wire along the second helical path comprises positioning the second pull wire along the second helical path that completes two revolutions around the circumference of the inner liner between the proximal end of the non-deflection portion and the distal end of the non-deflectable portion.

18. The method of claim 16 , wherein positioning the second pull wire along the second helical path comprises positioning the second pull wire along the second helical path offset from the first helical path by 180 degrees in a circumferential direction around the inner liner.

19. The method of c

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Tegg Troy
• Ebner Bruce
• Knight Cherry

Classifications

• A61M25/0012

  with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils · CPC title

• A61M25/0147 Primary

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

• A61M25/0138

  having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils · CPC title

• B29C65/00

  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 title

• A61M25/0045

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