Expandable guide sheath and apparatus and methods for making them

• US 7,713,281 B2
• Filed: 10/04/2004
• Issued: 05/11/2010
• 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.
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): HORNBERGER, JENNIFER LEA
• Application Number:
  US10/958,034
• Publication Number:
  US 20050149104A1
• Time in Patent Office: 2,045 Days
• Field of Search: 606/108, 606191-200, 600/208, 600/184, 604/96.01, 604/103.04, 604/915, 604/103.05, 604/107, 604/525, 604/528, 604/509, 623/1.11
• US Class Current: 606/194
• 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 including a proximal end, a distal end sized for insertion into the body lumen, and a sidewall defining a lumen of the tubular member, the lumen extending from the proximal end to the distal end, and the tubular member having a length defined from the proximal end to the distal end;

an elongate stiffening member including a distal end, the elongate stiffening member being fixedly attached to the sidewall of the tubular member, at the distal end of the tubular member, and extending distally from the distal end of the tubular member to the distal end of the elongate stiffening member tip, over a length that is shorter than the length of the tubular member; and

an expandable sheath including a distal terminal end, the sheath extending distally from the distal end of the tubular member, along a portion of the elongate stiffening member to the distal terminal end of the sheath, the expandable sheath defining a lumen that communicates with the tubular member lumen and includes a distal opening, the distal opening of the sheath lumen being defined by a portion of a perimeter of the distal terminal end of the sheath that becomes spaced apart from the elongate member, when the expandable sheath is expanded, and the distal opening of the expandable sheath lumen allowing passage therethrough, alongside the elongate stiffening member, of a medical instrument into the body lumen, the medical instrument having been passed through the tubular member lumen and the sheath lumen;

wherein the distal end of the elongate stiffening member extends distally beyond the distal opening of the expandable sheath lumen, and the apparatus further comprises an expandable occlusion member attached to the distal end of the elongate stiffening member.

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 comprises a sheet of material whose edges are attached to the elongate stiffening member.

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

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

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

9. The apparatus of claim 8, wherein the sheath is attached substantially continuously to the elongate stiffening member.

10. The apparatus of claim 1, wherein the sheath comprises an elastomeric material.

11. The apparatus of claim 1, wherein the expandable sheath includes another lumen, and the elongate stiffening member is disposed at least partially within the other lumen.

12. The apparatus of claim 1, wherein the length of the tubular member is about one hundred ten centimeters (110 cm) or more.

13. The apparatus of claim 1, wherein the length over which the elongate stiffening member extends distally from the distal end of the tubular member is between about ten and fifty centimeters (10-50 cm).

14. The apparatus of claim 1, wherein the length over which elongate stiffening member extends distally from the distal end of the tubular member is not more than about thirty centimeters (30 cm).

15. The apparatus of claim 1, wherein the elongate stiffening member includes a lumen extending at least between the distal end of the tubular member and the distal end of the elongate stiffening member.