Strain management in stent delivery system

• US 9,532,891 B2
• Filed: 06/19/2014
• Issued: 01/03/2017
• Est. Priority Date: 05/09/2003
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Dorn, Jurgen
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/309,661
• Publication Number:
  US 20140303712A1
• Time in Patent Office: 929 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61M 2025/0059 having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod

Abstract

A delivery system for a medical implant and a method of delivering the medical implant. The delivery system includes an inner catheter and an outer catheter. The inner catheter includes a wire coil disposed between an inner tube and an outer tube, the wire coil having gaps between turns of the coil at a proximal and a distal region thereof. The outer catheter is disposed about the inner catheter. The system includes a flow path for liquid from a proximal end to a distal end thereof, the flow path including a radially extending portion through the gaps. The method includes inserting the delivery system into a body lumen, injecting visualizing fluid into the proximal end of the system, the visualizing fluid moving through the flow path and exiting the distal end of the system, and retracting the outer catheter to release the medical implant.

Claims

1. A delivery system for a medical implant, comprising:

an inner catheter including a wire coil disposed between an inner tube and an outer tube, the wire coil having gaps between turns of the coil at a proximal and a distal region thereof, and the inner tube defines a medical implant bed at a distal end thereof;

an outer catheter disposed about the inner catheter;

a flow path for liquid from a proximal end to a distal end of the system, the flow path including a radially extending portion through the gaps;

a self-expanding stent, having a radially expanded configuration and a radially compressed configuration, disposed about the medical implant bed and maintained in the collapsed configuration by the outer catheter; and

a pusher element, including a flange portion, attached to the inner tube proximal of the stent bed, the flange portion abutting a proximal end of the stent preventing proximal movement thereof.

2. The delivery system according to claim 1, wherein the outer tube is disposed over an intermediate region of the wire coil having a closed-coil structure.

3. The delivery system according to claim 2, wherein the outer tube comprises PTFE configured to fit tightly over the wire coil preventing adjacent turns of the coil from overlapping.

4. The delivery system according to claim 3, wherein the flow path in the intermediate region is bounded by the inner tube and adjacent turns of the coil.

5. The delivery system according to claim 1, wherein the flow path includes a helical path between the adjacent turns of the coil and the outer tube.

6. The delivery system according to claim 1, wherein the pusher element includes a shoulder portion.

7. The delivery system according to claim 6, wherein an adhesive is disposed between at least a section of the shoulder portion and the inner tube.

8. The delivery system according to claim 6, wherein a distal end of wire coil is disposed over at least a section of the shoulder portion to secure the position of the pusher element with respect to the inner tube.

9. The delivery system according to claim 6, wherein the pusher element comprises PEEK.

10. The delivery system according to claim 6, further comprising a marker attached to a distal end of the outer catheter, wherein the pusher element comprises a radiopaque material.

11. The delivery system according to claim 1, further comprising a tip connected to a distal end of the system, the tip including a guide wire lumen.

12. The delivery system according to claim 11, wherein the tip is a tapered extension of one of the inner tube and outer sheath.

13. The delivery system according to claim 11, wherein the tip is a separate element adhesively bonded to the inner tube.

14. The delivery system according to claim 11, wherein the tip comprises polyurethane.

15. The delivery system according to claim 1, further comprising a push rod disposed about a proximal end of the inner tube, a distal end of the push rod abutting a proximal end of the wire coil.

16. The delivery system according to claim 1, further comprising an actuating apparatus connected to a proximal end of both the inner catheter and outer catheter, the actuating apparatus configured to proximally move the outer catheter relative to the inner catheter.

17. The delivery system according to claim 16, further comprising a lubricous coating disposed between the outer tube and the outer catheter.

18. The delivery system according to claim 1, further comprising a first marker band attached to a distal end of the outer catheter and a second marker band attached to the inner catheter adjacent a distal end of the wire coil.

19. The delivery system according to claim 1, wherein the outer tube comprises PTFE and the outer catheter comprises HYTREL, further comprising a lubricious silicone material disposed between the outer tube and outer catheter.

20. The delivery system according to claim 1, wherein the wire coil extends beyond the outer tube both proximally and distally approximately 10 mm.

21. The delivery system according to claim 1, wherein the gaps in the proximal region are proximal of a proximal end of the outer tube and the gaps in the distal region are distal of a distal end of the outer tube.

22. The delivery system according to claim 1, wherein the outer catheter is configured for tight disposition over the outer tube such that no radial gap is present therebetween.

23. The delivery system according to claim 1, wherein the outer catheter is circumferentially pre-stressed such that the inside diameter thereof is less than the outside diameter of the outer tube.

24. The delivery system according to claim 1, wherein the inner tube is comprised of a material selected from the group consisting essentially of polymers, metals, and combinations thereof.

25. The delivery system according to claim 1, wherein the wire coil is comprised of a material selected from the group consisting essentially of nickel titanium alloy, stainless steel, and combinations thereof.

26. The delivery system according to claim 1, wherein the wire coil imparts radial, torsional and compressive reinforcement to the inner tube.

27. A method of delivering a medical implant to a body lumen, comprising:

inserting a medical implant delivery system into the body lumen, the system including an inner catheter having a wire coil disposed between an inner tube and an outer tube, the wire coil having gaps between turns of the coil at a proximal and a distal region thereof, the inner tube defining a medical implant bed at a distal end thereof, an outer catheter disposed about the inner catheter, and a flow path for liquid from a proximal end to a distal end of the system, the flow path including a radially extending portion through the gaps, a self-expanding stent having a radially expanded configuration and a radially compressed configuration disposed about the medical implant bed and maintained in the collapsed configuration by the outer catheter, and a pusher element, including a flange portion, attached to the inner tube proximal of the stent bed, the flange portion abutting a proximal end of the stent preventing proximal movement thereof;

injecting visualizing fluid into the proximal end of the delivery system, the visualizing fluid moving through the flow path and exiting the distal end of the system; and

retracting the outer catheter proximally relative to the inner catheter to release a medical implant disposed between the outer catheter and inner catheter at the distal end of the delivery system.

28. The method according to claim 27, wherein the inner catheter is disposed closely inside the outer catheter to support the outer catheter during the retracting such that diametrical contraction and longitudinal expansion of the outer catheter is generally inhibited during the retracting step.

29. The method according to claim 27, wherein a first marker band is attached to a distal end of the outer catheter and a second marker band is attached to the inner catheter adjacent a distal end of the wire coil, the retracting step further comprising aligning the first marker band with the second marker band to confirm deployment of the medical implant.