Composite laminated catheter with flexible segment and method of making same

• US 20070250040A1
• Filed: 04/19/2006
• Published: 10/25/2007
• Est. Priority Date: 04/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Core, Lee, Provost, Michelle, Papa, Michael, Riopel, Michael
• Granted Patent: US 8,308,712 B2
• Time in Patent Office: Days
• US Class Current: 604/525
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0015 Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
• 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 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• 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 25/0054 with regions for increasing flexibility

Abstract

A medical catheter including a composite laminated shaft having a segment that is mechanically deformed to have reduced stiffness.

Claims

1. A medical catheter comprising:

an elongate catheter shaft comprising;

a flexible polymeric liner;

a flexible polymer jacket adherently surrounding the liner;

a reinforcement layer interposed between the liner and the jacket; and

a mechanically deformed shaft segment having reduced stiffness as compared to a shaft segment that is not so deformed; and

a fitting mounted at a proximal end of the shaft.

2. The medical catheter of claim 1 wherein the catheter shaft further comprises a wall, the wall of the deformed segment being thinner than the wall of the shaft segment that is not so deformed.

3. The medical catheter of claim 2 wherein the catheter shaft further comprises a substantially uniform diameter bore extending there through.

4. The catheter of claim 1, wherein the reinforcement layer comprises one or more filaments braided or spirally wound about the liner and forming a plurality of interstices, the jacket and the liner being adhered to each other through the interstices.

5. The medical catheter of claim 4 wherein the deformed shaft segment has a braid pitch that is less than a braid pitch of a segment of the shaft that is not so deformed.

6. The catheter of claim 1, wherein the catheter shaft further comprises a wall, the wall of the deformed segment comprising a plurality of regions of delamination.

7. The catheter of claim 6, wherein the regions of delamination are substantially uniformly distributed within the wall of the deformed segment.

8. The catheter of claim 1, further comprising a guidewire tube extending alongside a selected portion of the shaft and being secured thereto, the guidewire tube having a round lumen extending longitudinally there through and being open at proximal and distal ends thereof for slidably receiving a medical guidewire.

9. The catheter of claim 8, wherein the jacket is absent along the selected portion of the shaft to expose at least an outer surface of the reinforcement layer, the guidewire tube being secured there to.

10. The catheter of claim 9, wherein the selected portion of the shaft is disposed distally adjacent the deformed segment of the shaft.

11. The catheter of claim 1, wherein the deformed segment is disposed adjacent a distal end of the shaft.

12. The catheter of claim 1, further comprising a soft distal tip attached to a distal end of the shaft.

13. The catheter of claim 1, wherein a distal portion of the catheter has a curvilinear shape.

14. A method of making a medical catheter, comprising:

providing a catheter shaft by;

forming a polymeric liner;

applying a reinforcement layer over the liner; and

forming a polymeric jacket over the reinforcement layer;

mechanically deforming a shaft segment to reduce stiffness therein; and

attaching a fitting to a proximal end of the shaft.

15. The method of claim 14, wherein mechanically deforming includes a process selected from a group consisting of rolling, swaging, rotary swaging, roller swaging, hydraulic swaging, and radial forging.

16. The method of claim 14, wherein mechanically deforming includes reducing a diameter of the deformed shaft segment.

17. The method of claim 14, wherein the reinforcement layer comprises braided filaments.

18. The method of claim 17, wherein mechanically deforming decreases a pitch of the braided filaments.

19. The method of claim 14, wherein mechanically deforming creates a plurality of regions of delamination in the shaft.

20. The method of claim 19, wherein the regions of delamination are substantially uniformly distributed within the shaft.

21. The method of claim 14, wherein forming a liner comprises extruding the liner over a mandrel.

22. The method of claim 14, wherein mechanically deforming further comprises providing a mandrel to support a bore through at least the mechanically deformed segment of the catheter shaft.

23. The method of claim 14 further comprising cutting the shaft to a selected length.

24. The method of claim 14, further comprising cutting a groove in the jacket of the catheter shaft, the groove encircling the reinforcement layer and being positioned near a distal end of the shaft.

25. The method of claim 24, further comprising positioning a fill component within the groove, the fill component having a hardness which is less than the hardness of the jacket.