Expandable guide sheath and apparatus and methods for making them

• US 20050149104A1
• Filed: 10/04/2004
• Published: 07/07/2005
• Est. Priority Date: 10/03/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Loew, Christopher, Mourlas, Nicholas J., Leeflang, Stephen A., Ventura, Christine P., Eversull, Christian S.
• Granted Patent: US 7,713,281 B2
• Time in Patent Office: Days
• US Class Current: 606/198
• 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: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0035 characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

Apparatus and methods are provided for providing access to a body lumen. The apparatus includes a tubular member including a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending between the proximal and distal ends. A pushable stiffening member extends from the distal end of the tubular member, the elongate member terminating in a distal tip. An expandable sheath extends along at least a portion 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 communicating with the tubular member lumen. In one embodiment, the sheath includes an outer lumen and an inner lumen floating within the outer lumen, and the stiffening member is carried in the inner lumen.

Claims

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

a tubular member comprising a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending between the proximal and distal ends;

an elongate member extending from the distal end of the tubular member, the elongate member terminating in a distal tip; and

an expandable sheath extending along at least a portion of the elongate member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the elongate member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen.

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

3. The apparatus of claim 1, wherein the sheath comprises a polymer.

4. The apparatus of claim 3, wherein the polymer comprises at least one of PTFE, ePTFE, FEP, PET, urethane, olefin, and PE.

5. The apparatus of claim 1, wherein the sheath is attached to the elongate member at one or more locations between the distal end of the tubular member and the distal tip of the elongate member.

6. The apparatus of claim 1, wherein the sheath comprises a sheet of material whose edges are attached to the elongate member.

7. The apparatus of claim 1, wherein the sheath comprises a distal end having an opening such that an instrument inserted into the tubular member lumen may be advanced through the tubular member and sheath and extend from the opening into a body lumen.

8. The apparatus of claim 1, wherein the sheath comprises a wall thickness not more than about 0.01 inch (0.25 mm).

9. The apparatus of claim 1, wherein the elongate member has sufficient column strength that the distal tip may be advanced through a body lumen by pushing the proximal end of the tubular member without substantial risk of the elongate member kinking or buckling.

10. The apparatus of claim 1, wherein the elongate member comprises a guidewire or a catheter.

11. The apparatus of claim 1, wherein the elongate member extends substantially parallel to a longitudinal axis of the sheath.

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

13. The apparatus of claim 12, wherein the sheath is attached substantially continuously to the elongate member.

14. The apparatus of claim 1, wherein the sheath comprises a plurality of lumens that extend longitudinally through the sheath.

15. The apparatus of claim 1, wherein the distal tip of the elongate member extends beyond a distal end of the expandable sheath, the apparatus further comprising an expandable occlusion member on the distal tip.

16. The apparatus of claim 15, wherein the occlusion member comprises a passage extending therethrough that communicates with the sheath lumen, the passage terminating in a transverse opening in a wall of the occlusion member.

17. A method for accessing a body lumen using an apparatus including a tubular proximal portion and an expandable distal portion having a size smaller than the proximal portion, the method comprising:

advancing the distal portion into a patient'"'"'s body with an expandable sheath thereon in a contracted condition, the proximal portion reaching a first location when the distal portion extends into a target location;

expanding the expandable sheath, thereby providing a substantially continuous lumen through the proximal and distal portions to the target location; and

advancing an elongate instrument through the proximal portion and the expandable sheath to deliver the instrument to the target location.

18. The method of claim 17, further comprising removing the apparatus from the body lumen, while maintaining the instrument at the target location.

19. The method of claim 17, wherein the apparatus comprises a handle apparatus including inner and outer members, the method further comprising inserting the instrument into the inner member before advancing the instrument.

20. The method of claim 19, further comprising withdrawing the outer member of the handle apparatus while maintaining the inner member substantially stationary, thereby cutting the proximal portion and the expandable sheath to separate and remove the apparatus from the body lumen.

21. A handle apparatus for a sheath apparatus, comprising:

an outer member comprising proximal and distal ends, and a lumen extending therebetween;

an elongate tubular member extending from the distal end of the outer member; and

an inner member connectable to the outer member, the inner member comprising a cutting element such that, when the outer member is withdrawn proximally relative to the inner member, the cutting element may cut through the tubular member to allow the tubular member to be removed around the inner member.

22. The handle apparatus of claim 21, wherein the inner member comprises a seal for receiving an instrument through the inner member while maintaining a seal between the instrument and inner member.

23. The handle apparatus of claim 21, wherein the inner and outer members comprises interlocking elements for limiting relative motion between the inner and outer members.

24. The handle apparatus of claim 23, wherein the interlocking elements comprises a slot in the outer member and a radial element extending from the inner member.

25. The handle apparatus of claim 21, wherein at least a portion of the tubular member is expandable.

26. A method for delivering an instrument into a branch body lumen from a main body lumen within a patient'"'"'s body, the method comprising:

advancing a distal portion of a sheath apparatus into the patient'"'"'s body until a distal end of the sheath apparatus is disposed in the main body lumen adjacent the branch body lumen;

expanding an occlusion member on the distal end of the sheath apparatus within the main body lumen; and

introducing an instrument into the sheath apparatus, the instrument passing through an expandable sheath on the sheath apparatus until a distal end of the instrument is adjacent the occlusion member; and

advancing the instrument further, the occlusion member at least partially directing the distal end of the instrument into the branch body lumen.

27. The method of claim 26, wherein the occlusion member is expanded within the main body lumen distal to the branch body lumen, the step of advancing the instrument comprising:

advancing the instrument until the distal end of the instrument exits an outlet of the expandable sheath and is exposed within the main body lumen; and

advancing the instrument further such that the exposed distal end contacts the occlusion member, the occlusion member deflecting the instrument into the branch body lumen.

28. The method of claim 26, wherein the occlusion member comprises a transverse passage therein communicating with the expandable sheath, the step of advancing the instrument comprising advancing the instrument such that the distal end passes through the transverse passage and exits transversely from the occlusion member into the branch body lumen.

29. The method of claim 26, wherein the expandable sheath is expanded before the instrument is introduced into the sheath apparatus.

30. The method of claim 26, further comprising removing the sheath apparatus from the main body lumen, while the instrument remains within the branch body lumen.

31. The method of claim 26, wherein the sheath apparatus comprises a handle apparatus including inner and outer members, the method further comprising inserting the instrument into the inner member before advancing the instrument.

32. The method of claim 31, further comprising withdrawing the outer member of the handle apparatus while maintaining the inner member substantially stationary, thereby cutting the proximal portion and the expandable sheath to separate and remove the sheath apparatus from the patient'"'"'s body.