Expandable guide sheath and apparatus and methods for using such sheaths

• US 9,839,771 B2
• Filed: 03/18/2009
• Issued: 12/12/2017
• Est. Priority Date: 04/25/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Eversull, Christian Scott, Mourlas, Nicholas J., Leeflang, Stephen Arie, Nayak, Asha Shrinivas, Miller, David John
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): Bachman, L.
• Application Number:
  US12/406,897
• Publication Number:
  US 20090182278A1
• Time in Patent Office: 3,191 Days
• Field of Search: 604101, 604103, 604508, 604509, 604523, 604527, 600184
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Apparatus and methods are provided for accessing body lumens and/or for delivering instruments into body lumens, e.g., vessels within a patient'"'"'s vasculature. A flexible sheath is provided that is expandable from a contracted condition to an enlarged condition wherein the sheath at least partially defines a lumen therein. The sheath is lubricious and has a relatively thin wall, thereby providing a collapsible/expandable guide for delivering fluids and/or instruments through tortuous anatomy and/or into relatively narrow passages. The sheath is advanced from an entry site to a body lumen in the contracted condition. Once the sheath reaches a target body lumen, the sheath is expanded to the enlarged condition, thereby defining a lumen within the sheath, and fluids and/or instruments are introduced into the body lumen via the sheath lumen. Upon completing the procedure, the sheath is removed from the body lumen.

Claims

1. An apparatus for providing access to a body lumen of a patient, comprising:

a flexible stiffening member having a proximal end and a distal end having a size and shape for insertion into a body lumen and defining a maximum outer cross-section, the stiffening member being flexible to facilitate advancement through tortuous anatomy; and

an expandable sheath extending from the proximal end to the distal end of the stiffening member and attached to the stiffening member distal end, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the stiffening member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member, the lumen having an inner diameter larger than the maximum outer cross-section of the distal end of the stiffening member.

2. The apparatus of claim 1, wherein the stiffening member comprises a distal tip that extends beyond the distal end of the sheath.

3. The apparatus of claim 1, wherein the stiffening member comprises a substantially atraumatic distal tip.

4. The apparatus of claim 1, wherein the stiffening member is received in a separate pocket or lumen of the sheath that extends between proximal and distal ends of the sheath.

5. The apparatus of claim 4, wherein the stiffening member is attached to the sheath within the lumen.

6. The apparatus of claim 1, wherein the sheath comprises a lubricious material.

7. The apparatus of claim 1, wherein the stiffening member comprises an elongate member extending substantially parallel to a longitudinal axis of the sheath.

8. The apparatus of claim 1, wherein the sheath is attached to the stiffening member at one or more locations.

9. The apparatus of claim 8, wherein the sheath is attached to the stiffening member at the proximal and distal ends of the stiffening member.

10. The apparatus of claim 8, wherein the sheath is attached substantially continuously to the stiffening member between the proximal and distal ends of the stiffening member.

11. The apparatus of claim 1, wherein the stiffening member comprises a guidewire lumen extending between the proximal and distal ends, the guidewire lumen having an inner diameter smaller than the inner diameter of the lumen of the expandable sheath in the enlarged condition.

12. The apparatus of claim 1, further comprising a “

J”

tip on the distal end of the stiffening member.

13. The apparatus of claim 1, wherein the stiffening member has a maximum outer cross-section between about 0.05-5 millimeters.

14. The apparatus of claim 1, wherein the stiffening member has a maximum outer cross-section between about 0.2-2 millimeters.

15. The apparatus of claim 1, further comprising a handle on the proximal end of the sheath and wherein the sheath extends from the handle to the stiffening member distal end.

16. An apparatus for providing access to a body lumen of a patient, comprising:

a flexible stiffening member having a proximal end, a distal end having a size and shape for insertion into a body lumen and defining a maximum outer cross-section, the stiffening member being flexible to facilitate advancement through tortuous anatomy and having sufficient length to be advanced from a location outside a patient'"'"'s body through any intervening body passages into a site to be accessed; and

an expandable sheath expandable from a contracted condition to minimize a profile of the sheath and an enlarged condition, the expandable sheath being flimsy and extending between the proximal and distal ends of the stiffening member, the sheath being expandable from the contracted condition to allow insertion along with the stiffening member into a body lumen, and the enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member, the lumen of the sheath having an inner diameter larger than the maximum outer cross-section of the distal end of the stiffening member in the enlarged condition.

17. The apparatus of claim 16, wherein the sheath may be split into one or more pieces to allow the sheath to be removed easily from around an electrical lead advanced through the lumen of the sheath.

18. The apparatus of claim 16, further comprising an electrical lead that may be advanced through the lumen of the sheath after the sheath has been advanced along with the stiffening member to the site to be accessed.

19. The apparatus of claim 16, wherein the stiffening member is received in a separate pocket or lumen of the sheath that extends between proximal and distal ends of the sheath.

20. The apparatus of claim 16, wherein the stiffening member extends substantially parallel to a longitudinal axis of the sheath.

21. The apparatus of claim 16, wherein the sheath is attached to the stiffening member at one or more locations.

22. The apparatus of claim 16, the stiffening member further comprising one or more lumens extending between the proximal and distal ends.

23. The apparatus of claim 16, wherein the apparatus has a low profile defining an outer diameter or other maximum cross-section when the expandable sheath is in the contracted condition, and wherein the inner diameter of the lumen is between about three and ten times larger than the diameter or other maximum cross-section of the low profile of the apparatus.

24. The apparatus of claim 16, wherein the apparatus defines an outer diameter or other maximum cross-section between about 0.1 and about ten millimeters (0.1-10 mm) when the expandable sheath is in the contracted condition, and wherein the inner diameter of the lumen of the expandable sheath is larger than the outer diameter or other maximum cross-section of the apparatus when expanded to the enlarged condition.

25. An apparatus for providing access to a body lumen of a patient, comprising:

a flexible stiffening member having a proximal end, a distal end having a size and shape for insertion into a body lumen, and one or more lumens extending between the proximal and distal ends; and

an expandable sheath extending from the proximal end to the distal end of the stiffening member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the stiffening member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member, the sheath comprising a lubricious coating for facilitating inserting one or more instruments through the lumen,

wherein the apparatus has an outer profile when the expandable sheath is in the contracted condition between about 0.1 and about ten millimeters (0.1-10 mm), and wherein the expandable sheath defines a lumen in the enlarged condition that is larger than the outer profile and having a diameter or other maximum cross-section between about 0.3 and about one hundred millimeters (0.3-100 mm).

26. A system for treating a patient via a body lumen, comprising:

a flexible stiffening member having a proximal end, and a distal end having a size and shape for insertion into a body lumen and defining an outer diameter;

an expandable sheath extending between the proximal and distal ends of the stiffening member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the stiffening member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member, the lumen of the sheath having an inner diameter in the enlarged condition larger than the outer diameter of the distal end of the stiffening member; and

an electrical lead advanceable through the lumen of the sheath after the sheath has been advanced along with the stiffening member into a desired body lumen of a patient,

wherein the sheath comprises a lubricious coating for facilitating inserting the lead through the lumen.

27. An apparatus for providing access to a body lumen of a patient, comprising:

an expandable flimsy, inelastic sheath comprising a proximal end, a distal end, and a length sufficient for the sheath to extend between an entry site into a patient'"'"'s body and a target body lumen, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends; and

one or more flexible reinforcing members extending along the sheath, the one or more reinforcing members having a cross-section smaller than the lumen of the sheath in the enlarged condition,

wherein the apparatus has an outer profile when the expandable sheath is in the contracted condition defining a first diameter or other maximum cross-section, and wherein the expandable sheath defines a lumen having a second inner diameter or other maximum cross-section in the enlarged condition that is between about three and ten times larger than the first diameter or other maximum cross-section of the outer profile of the apparatus.