METHODS AND SYSTEMS FOR SECURING A SLEEVE FOR ENDOLUMINAL DEVICES

• US 20140106951A1
• Filed: 10/14/2013
• Published: 04/17/2014
• Est. Priority Date: 10/15/2012
• Status: Abandoned Application

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Brandon, Kevin S.
• Application Number:
  US14/053,433
• Publication Number:
  US 20140106951A1
• Time in Patent Office: Days
• US Class Current: 493/384
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: B31D 5/0086 Making hollow objects B31D5/0082, B31D5/0095, B31D5/02, B31D5/04 take precedence

Abstract

The present disclosure describes methods and apparatus for preparing a sleeve used to surround and assist in delivering an expandable implant to the vasculature of a human patient. The sleeve is formed by curving a sheet of material, longitudinally folding the material, and securing the longitudinally folded material with an elongated member, such as wire or thread, to form a sleeve. The resulting sleeve can then receive an endoluminal device.

Claims

1. A device for forming a constraining sleeve for surrounding an endoluminal device comprising:

an introducing section configured to receive and position a material with a top side, a bottom side, a first longitudinal edge, and a second longitudinal edge, wherein the first longitudinal edge and the second longitudinal edge are positioned proximate each other,

a folding section comprising a pair of opposing rollers, each roller having a plurality of roller teeth configured to longitudinally fold the material, wherein at least one of the pair of opposing rollers comprises a notch; and

a threading section comprising a threading element, wherein the threading element is configured to interface with the notch of the pair of opposing rollers and is capable of puncturing the material.

2. The device of claim 1, wherein the threading element comprises a hollow needle.

3. The device of claim 1, wherein the pair of opposing rollers are substantially horizontal.

4. The device of claim 1 further comprising an elongated member.

5. The device of claim 4, wherein the elongated member is a metal wire.

6. The device of claim 4, wherein the elongated member is one of ePTFE, polyester, polyurethane, fluoropolymers, perfouorelastomers, polytetrafluoroethylene, silicones, urethanes, ultra high molecular weight polyethylene, aramid fibers, or combinations thereof.

7. The device of claim 1, wherein the material is an ePTFE sheet.

8. The device of claim 1 further comprising a base.

9. The device of claim 8, wherein the introducing section, the folding section, and the threading element are removably coupled to the base.

10. The device of claim 1 further comprising a sled, wherein the threading element is coupled to the sled.

11. A method for forming a constraining sleeve for surrounding an endoluminal device comprising:

loading a material having a top side, a bottom side, a first longitudinal edge, and a second longitudinal edge, wherein the first longitudinal edge and the second longitudinal edge are positioned proximate each other into a device comprising an introducing section configured to receive the material, a pair of opposing rollers, each roller having a plurality of roller teeth and a notch, and a threading element;

advancing the material to the pair of opposing rollers;

rotating the pair of opposing rollers and advancing the material through the pair of opposing rollers to form a longitudinally folded material;

creating a plurality of holes in the longitudinally folded material with the threading element;

passing an elongated member through the plurality of holes; and

securing the elongated member at an end of longitudinally folded material to form a constraining sleeve.

12. The method of claim 11, further comprising curving the material such that the first longitudinal edge and the second longitudinal edge are in contact with each other and substantially parallel.

13. The method of claim 11, further comprising inserting the endoluminal device into the constraining sleeve.

14. The method of claim 11, wherein the pair of opposing rollers are substantially horizontal.

15. The method of claim 11, wherein the threading element is a needle.

16. The method of claim 11, wherein the elongated member is a metal wire.

17. The method of claim 11, wherein the elongated member is one of ePTFE, polyester, polyurethane, fluoropolymers, perfouorelastomers, polytetrafluoroethylene, silicones, urethanes, ultra high molecular weight polyethylene, aramid fibers, or combinations thereof.

18. The method of claim 11, wherein the material is ePTFE.

19. A method of making a sleeve for containing a medical device, the method comprising the steps of:

clamping and advancing the sleeve between rotating meshed teeth of two opposing gears, thereby forming a plurality of folds along an edge of the sleeve; and

piercing the plurality of folds along the edge of the sleeve with an end of a tubular piercing member as the sleeve is advanced.

20. The method as set forth in claim 19, wherein the opposing gears are provided with aligned circumferentially extending grooves, wherein the end of the tubular piercing member is aligned with the grooves.

21. The method as set forth in claim 19, including the step of feeding an elongate member through the tubular piercing member while the plurality of folds along the edge of the sleeve remains disposed on the tubular piercing member.

22. The method as set forth in claim 21, including the step of removing the plurality of folds along the edge of the sleeve from the tubular piercing member, wherein the elongate member remains disposed through the plurality of folds along the edge of the sleeve.