Endoluminal prosthesis deployment devices and methods

• US 10,695,206 B2
• Filed: 07/28/2016
• Issued: 06/30/2020
• Est. Priority Date: 07/30/2015
• Status: Active Grant

• Current Assignee: Trivascular Incorporated
• Original Assignee: Trivascular Incorporated
• Inventors: Aristizabal, Diego, Ehnes, Dale L, Woodson, Teresa
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/737,881
• Publication Number:
  US 20180296378A1
• Time in Patent Office: 1,433 Days
• Field of Search: 623 111, 623 146
• 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 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

Catheter systems and methods for deployment of an endoluminal prosthesis in a body lumen of a patient while maintaining control of a position of the endoluminal prosthesis during the deployment process. Some of the systems and methods are configured to minimize frictional forces of components of the catheter systems during deployment procedures.

Claims

1. A catheter system for deploying an endoluminal prosthesis in a body lumen of a patient, comprising:

a flexible elongate chassis having a proximal end, a distal end, a distal section and an overall column strength sufficient for advancement of the chassis through a body lumen of a patient;

a self-expanding tubular endoluminal prosthesis disposed in a constrained state over the distal section of the chassis; and

a thin, flexible, resilient extension comprising

a proximal end which is secured in fixed relation to the chassis,

a distal end which is disposed radially outward from an outside surface of the chassis and distal of the proximal end of the extension; and

wherein the extension extends through a wall of a distal end of the endoluminal prosthesis with the extension in a radially constrained state such that the extension at least partially captures a distal segment of the endoluminal prosthesis and restricts proximal displacement of the endoluminal prosthesis relative to the chassis, wherein the extension comprises an s-shape in an unconstrained relaxed state, and wherein a proximal most deflection of the s-shape of the extension extends away from the chassis and a distal most deflection of the s-shape of the extension extends towards the chassis.

2. The catheter system of claim 1 wherein an angle of flexible extension formed with respect to a longitudinal axis of chassis is 5 degrees to 50 degrees with extension in a relaxed unconstrained state.

3. The catheter system of claim 1 wherein the extension comprises a length of 4 mm to 25 mm.

4. The catheter system of claim 1 wherein the extension comprises a transverse cross section area of 0.08 mm² to 1 mm².

5. The catheter system of claim 1 comprising a plurality of thin, flexible, resilient extensions, each of the plurality of extensions comprising:

a proximal end which is secured in fixed relation to the chassis,

a distal end which is disposed radially outward from an outside surface of the chassis and distal of the proximal end of the extension; and

wherein each of the plurality of extensions extend through a wall of a distal end of the endoluminal prosthesis with the extensions in a radially constrained state such that each extension at least partially captures a distal segment of the endoluminal prosthesis and restricts proximal displacement of the endoluminal prosthesis relative to the chassis.

6. The catheter system of claim 5 wherein the plurality of extensions are evenly distributed with respect to circumferential orientation about the chassis.

7. The catheter system of claim 5 comprising 2 extensions to 6 extensions.

8. The catheter system of claim 7 comprising 3 extensions.

9. The catheter system of claim 1 wherein the extension lies substantially in a same plane as a longitudinal axis of the chassis.

10. The catheter system of claim 9 wherein a thickness of the extension lies substantially in the same plane as the longitudinal axis of the chassis.

11. The catheter system of claim 1 wherein the distal segment captured by the extension comprises a stent element of a self-expanding stent of the endoluminal prosthesis.

12. The catheter system of claim 11 wherein the stent element captured by the extension comprises a crown section of the stent.

13. The catheter system of claim 1 wherein the extension comprises superelastic nickel titanium alloy.

14. The catheter system of claim 1 further comprising a tubular outer sheath which is disposed over the endoluminal prosthesis and chassis and which includes an inner surface that constrains the endoluminal prosthesis in the constrained state.

15. The catheter system of claim 14 further comprising a nosecone secured to a distal end of the chassis, the nosecone including a shoulder portion which is disposed within a distal end of the tubular outer sheath and the shoulder portion further comprising a slot which is configured to accept the distal end of the extension when the extension is in the radially constrained state.

16. The catheter system of claim 1 wherein the chassis comprises a guidewire lumen extending from the proximal end of the chassis to the distal end of the chassis.

17. The catheter system of claim 1 wherein the tubular endoluminal prosthesis comprises a tubular stent graft including at least one layer of compliant material secured to a self-expanding stent.

18. The catheter system of claim 17 wherein the thin compliant material comprises ePTFE.

19. The catheter system of claim 17 wherein the stent graft comprises a fully stented stent graft.