Steerable Delivery Sheaths

• US 20130116705A1
• Filed: 05/03/2012
• Published: 05/09/2013
• Est. Priority Date: 05/03/2011
• Status: Abandoned Application

• Current Assignee: Kalila Medical, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Brice Arnault de La Menardiere, Clayton Baldwin
• Inventors: Salahieh, Amr, Lepak, Jonah, Saul, Tom, Dueri, Jean-Pierre, Trautman, Joseph Creagan, Baldwin, Clayton, Leung, Emma, Menardiere, Brice Arnault De La
• Application Number:
  US13/463,498
• Publication Number:
  US 20130116705A1
• Time in Patent Office: Days
• US Class Current: 606/130
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 90/10 for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0013 Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

Steerable medical delivery devices and their methods of use.

Claims

1. A steerable delivery device comprising:

a steerable portion adapted to be steered; and

an outer sheath and an inner sheath disposed within the outer sheath along a first portion of the delivery device, the outer sheath comprising a first material and the second sheath comprising a second material, wherein the first and second materials are merged together at a merged location distal to the steerable portion, forming a unitary section of material at the merged location, wherein the inner and outer tubular members are adapted to be axially moved relative to one another along the steerable portion to steer the steerable portion.

2. The device of claim 1 wherein the first material is different than the second material.

3. The device of claim 1 wherein the inner sheath comprises a braided material extending along the steerable portion.

4. The device of claim 1 wherein the outer sheath comprises a tubular element in the steerable portion that includes a plurality of slots formed therein.

5. The device of claim 4 wherein the tubular element in the steerable element includes a first interlocking element and a second interlocking element each adapted to allow relative movement therebetween when in a first configuration and to prevent relative movement therebetween along at least one of a radial axis and an axial axis when in a second configuration.

6. The device of claim 4 wherein the outer sheath also comprises a second tubular element in the steerable portion secured to the tubular element, wherein the second tubular element has a plurality of second slots formed therein in a pattern different than the plurality of slots formed in the tubular element.

7. The device of claim 4 wherein the outer sheath comprises a braided material proximal to the steerable portion, wherein a distal end of the braided material and a proximal end of the tubular element are secured to one another.

8. The device of claim 1 wherein the device 1 further comprises a tensioning element disposed radially between the inner and outer sheaths in the steerable portion.

9. The device of claim 8 wherein the tensioning element is secured to the inner sheath proximal to the steerable portion and is secured to the unitary material in the merged location.

10. The device of claim 7 wherein a proximal end of the tensioning element is secured to the inner sheath such that the proximal end is closer to the steerable portion than it is to a proximal end of the inner sheath.

11. A steerable delivery device comprising:

a steerable portion adapted to be steered; and

an outer sheath and an inner sheath disposed within the outer sheath, wherein the outer sheath and the inner sheath are permanently axially fixed relative to one another at a location distal to the steerable portion, and wherein, in the steerable portion, the outer sheath comprises a tubular member with a first portion with a plurality of slots formed therein in a first pattern and a second portion with a plurality of slots formed therein in a second pattern different than the first pattern.

12. The device of claim 11 wherein the first pattern includes a first interlocking element and a second interlocking element each adapted to allow relative movement therebetween when in a first configuration and to prevent relative movement therebetween along at least one of a radial axis and an axial axis when in a second configuration.

13. The device of claim 11 wherein the inner sheath comprises a braided material extending along the steerable portion.

14. The device of claim 13 wherein the outer sheath comprises a braided material proximal to the steerable portion, wherein a distal end of the braided material and a proximal end of the first portion of the tubular element are secured to one another.

15. The device of claim 11 wherein the device 1 further comprises a tensioning element disposed radially between the inner and outer sheaths in the steerable portion.

16. The device of claim 15 wherein the tensioning element is secured to the inner sheath proximal to the steerable portion and is secured to a location on the device wherein the two tubular sheaths are permanently axially fixed relative to one another.

17. The device of claim 11 wherein the tubular member is a single tubular element such that the first portion and the second portion are unitary.

18. A steerable delivery device comprising:

a steerable portion adapted to be steered;

an outer sheath and an inner sheath disposed within the outer sheath and axially fixed to the outer sheath at a first location distal to the steerable portion, wherein the inner and outer tubular members are adapted to be axially moved relative to one another along the steerable portion to steer the steerable portion; and

a tensioning element secured to the inner sheath at a first location proximal to the steerable portion and secured at a second location where the inner and outer sheaths are axially fixed relative to one another, the tensioning element disposed radially between the outer and inner sheaths in the steerable portion, wherein the tensioning element is adapted to add axial stiffness to the steerable portion when the inner and outer sheaths are moved relative to one another when steering the steerable portion.

19. The device of claim 18 wherein the tensioning element is free floating between the first and second locations.

20. The device of claim 18 wherein the first location is closer to the steerable portion than to a proximal end of the inner sheath.

21. The device of claim 18 wherein tensioning element is adapted to be disposed on an inner curve of the steerable portion when the steerable portion is actuated.

22. The device of claim 18 wherein the tensioning element is made of Kevlar.

23. The device of claim 18 wherein the outer sheath includes a tube section with a plurality of slots formed therein in a first pattern.

24. The device of claim 23 wherein the first pattern includes a first interlocking element and a second interlocking element each adapted to allow relative movement therebetween when in a first configuration and to prevent relative movement therebetween along at least one of a radial axis and an axial axis when in a second configuration.

25. A steerable delivery device comprising:

an outer sheath and an inner sheath disposed within the outer sheath, wherein the inner sheath includes a first tubular element;

a steerable portion adapted to be steered;

wherein along the steerable portion the first tubular element includes a first section of a first material with a first durometer and a second section of a second material with a second durometer different than the first durometer, wherein the first and second sections are disposed at different radial portions of the first tubular element.

26. The device of claim 25 wherein the first durometer is greater than the second durometer.

27. The device of claim 26 wherein the first section and the steerable portion are adapted such that the first section is disposed on an inner curve of the steerable portion when the steerable portion is steered.

28. The device of claim 27 wherein the device further comprises a tensioning element disposed radially between the inner and outer sheaths along the steerable portion and adapted to be disposed on the inner curve of the steerable portion when the steerable portion is steered, and wherein the tensioning element is disposed directly adjacent to the first section.

29. The device of claim 26 wherein the first section extends about a quarter of the way around the circumference of the first tubular member.

30. The device of claim 26 wherein the first section is adapted to be disposed about 90 degrees away from an inner curve of the steerable portion when steered.

31. The device of claim 30 wherein the first section is two discrete sections around the circumference of the tubular member, and wherein each of the two sections is about 90 degrees away from the inner curve of the steerable portion when steered.

32. The device of claim 31 wherein the device further includes a tensioning element disposed radially between the inner and outer sheaths along the steerable portion, and wherein the tensioning element is disposed directly adjacent to the second section.

33. The device of claim 25 wherein the first tubular member consists of polymeric material.

34. The device of claim 25 wherein the outer and inner sheaths are axially fixed relative to one another at a first location distal to the steerable portion.

35. The device of claim 25 wherein the outer sheath includes a tube portion with a plurality of slots formed therein in a first pattern, and wherein the first pattern includes a first interlocking element and a second interlocking element each adapted to allow relative movement therebetween when in a first configuration and to prevent relative movement therebetween along at least one of a radial axis and an axial axis when in a second configuration.

36. A steerable delivery device comprising:

a steerable portion adapted to be steered;

an outer sheath and an inner sheath disposed within the outer sheath, the sheaths are axially fixed relative to one another distal to the steerable portion, and are adapted to be axially moved relative to one another along the steerable portion to steer the steerable portion;

a wire element secured to the inner sheath and to the outer sheath; and

a pulley secured to an external actuator,

wherein the wire element extends around the pulley and is adapted to be actuated to steer the steerable section.

37. The device of claim 36 wherein a distal end of the wire element is secured to a distal tip of the inner sheath.

38. The device of claim 37 wherein a proximal end of the wire element is secured to an outer surface of the outer sheath.

39. The device of claim 36 wherein a distal end of the wire element is secured to the proximal end of the inner sheath.

40. The device of claim 39 wherein a proximal end of the wire element is secured to a proximal end of the inner sheath.

41. The device of claim 36 wherein the outer sheath includes a tube portion with a plurality of slots formed therein in a first pattern, and wherein the first pattern includes a first interlocking element and a second interlocking element each adapted to allow relative movement therebetween when in a first configuration and to prevent relative movement therebetween along at least one of a radial axis and an axial axis when in a second configuration.