Catheter with splittable wall shaft and peel tool

• US 8,591,563 B2
• Filed: 09/26/2005
• Issued: 11/26/2013
• Est. Priority Date: 07/31/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Karpiel, John A., Kennedy, Kenneth C. II, Carter, Matthew P., Haller, Frederick B., Hardin, David M. Jr., Waller, David F.
• Primary Examiner(s): Houston, Elizabeth
• Application Number:
  US11/235,016
• Publication Number:
  US 20060030864A1
• Time in Patent Office: 2,983 Days
• Field of Search: 606191-199, 604/103.04, 604/164.05, 623/1.11, 623/1.12
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/9623 the sleeve being reinforced
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/09116 Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

A method and apparatus for uncoupling a wire guide from and elongate medical device comprising a catheter shaft having a wire guide lumen extending there through, wherein the material surrounding the wire guide lumen is selected or adapted to facilitate splittability for removal of the wire guide. The catheter shaft is coextruded and comprises a plurality of materials. The portion of the shaft adjacent the wire guide lumen is formed from a first material and the balance of the shaft is formed from a second material. The first material is selected or adapted to facilitate splittability as compared to the second material. The first material may have a lower durometer than the second material. A peel tool for separating the wire guide from the catheter shaft is also provided.

Claims

1. An elongate medical device for use with a wire guide having a distal end, the elongate medical device comprising a coextruded shaft extending between a distal end and a proximal end, and an eccentrically located lumen extending through at least a portion of the shaft, the lumen comprising a coupling region extending between a distal opening and a proximal opening, the coupling region being configured to receive the wire guide extending there through,

wherein the coextruded shaft comprises a unitary cross-section having a first material defining a first cross-sectional area and a second material dissimilar from the first material defining a second cross-sectional area, the first material being more splittable than the second material, the first cross-sectional area being disposed between and contiguous with at least a portion of the lumen and a first portion of an exterior surface of the shaft along at least a portion of the coupling region, the second cross-sectional area being contiguous with a second portion of the exterior surface, wherein the first material is splittable along an intermediate pathway of the first cross-sectional area that is spaced apart from an interface between the first material and the second material dissimilar from the first material, the intermediate pathway having no structural discontinuities for facilitating splitting there along and in advancement of being split, and wherein the first material is splittable along the intermediate pathway by an outwardly directed force of the wire guide disposed within the lumen as the wire guide is pulled out of and away from the shaft of the elongate medical device.

2. The elongate medical device of claim 1, wherein the first material has a durometer that is lower than that of the second material, and further wherein the first material is splittable as a result of the lower durometer of the first material.

3. The elongate medical device of claim 1, wherein the first material is weaker than the second material, and further wherein the first material is splittable as a result of the first material being weaker than the second material.

4. The elongate medical device of claim 1, wherein the lumen is completely surrounded and defined by the first cross-sectional area.

5. The elongate medical device of claim 1, further comprising a second lumen, the second lumen being completely surrounded and defined by the second cross-sectional area.

6. The elongate medical device of claim 1, wherein the shaft comprises an overall cross-sectional area, and the first cross-sectional area comprises less than 50 percent of the overall cross-sectional area of the shaft.

7. The elongate medical device of claim 6, wherein the second cross-sectional area comprises more than 50 percent of the overall cross-sectional area of the shaft.

8. The elongate medical device of claim 1, wherein the first material is configured to split along a pathway that traverses a central portion of the intermediate region of the first-cross-sectional area and is disposed within a plane that is parallel to and includes a longitudinal central axis of the shaft.

9. The elongate medical device of claim 1, wherein the elongate medical device comprises a sphincterotome having a cutting wire extending at least partially through a second lumen that is separate from the eccentrically located lumen.

10. The elongate medical device of claim 1, further comprising a peel tool engaged with the shaft and the wire guide, the peel tool being configure to facilitate separation of the wire guide from the shaft.

11. The elongate medical device of claim 10, wherein the peel tool comprises a body portion and an engagement portion, the body portion configured to be grasped by a user, the engagement portion comprising at least one groove for engaging one of the wire guide and the shaft.

12. The elongate medical device of claim 11, wherein the at least one groove comprises a first groove and a second groove, the first groove for engaging the wire guide and the second groove for engaging the shaft.

13. The elongate medical device of claim 10, wherein the peel tool comprises a central portion and a distal engagement portion, the central portion configured to slidably engage the shaft, and the distal engagement portion configured to engage the wire guide.

14. The elongate medical device of claim 10, wherein the peel tool is attached to an endoscope.

15. The elongate medical device of claim 1, wherein the first material comprises chemical properties that are different from those of the second material so as to adapt the first material to be more splittable than the second material.

16. A system comprising:

a. a catheter comprising a shaft and a plurality of lumens extending through at least a portion of the shaft, the plurality of lumens including a wire guide lumen defined by a wall of the shaft, the wall of the shaft comprising at least first and second cross-sectional areas, a first material defining the first cross sectional area and a second material dissimilar from the first material forming the second cross sectional area, one of the first and second cross-sectional areas including a portion of the wall extending between the wire guide lumen and an exterior surface of the wall, the portion of the wall being splittable along an interior pathway extending transversely through the wall of the shaft between the wire guide lumen and the exterior surface of the wall to allow access to the wire guide lumen, the interior pathway being spaced apart from an interface between the first material and the second material, the portion of the wall comprising a structurally and chemically uniform material in advancement of being split along the interior pathway;

b. a wire guide having a distal portion and a proximal portion, the distal portion extending through at least a portion of the wire guide lumen, the proximal portion extending out through the wall of the shaft; and

c. a peel tool having an engagement portion, the engagement portion being engaged with the wall of the shaft and the proximal portion of the wire guide, wherein distal movement of the peel tool relative to one of the wire guide and the shaft causes the wire guide to separate from the shaft.

17. The system of claim 16, wherein the wire guide lumen comprises an axis that is offset from a central axis of the shaft.