Delivery system for deployment and endovascular assembly of a multi-stage stented graft

• US 20020029075A1
• Filed: 07/19/2001
• Published: 03/07/2002
• Est. Priority Date: 02/26/1998
• Status: Active Grant

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Leonhardt, Howard J.
• Granted Patent: US 6,572,645 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A multi-stage stent graft for implantation into a blood vessel is disclosed. Each stage or layer may comprise radially compressible spring stents with or without a fabric covering, or may comprise a foamed tube. The various stages or layers may also have an adhesive coated thereon. The multi-stage stented graft and the adhesive coatings provide a surface for the ingrowth of cells and promote healing. Also disclosed is a coaxial delivery system for the delivery and endovascular assembly of the multi-stage stented graft during one trip into the vasculature.

Claims

1. A stent device, which comprises:

a) an anchoring stent having first and second, spaced apart stents connected to each other by at least one connecting wire; and

b) a scaffolding stent positioned intermediate the first and second stents of the anchoring stent.

2. The stent device of claim 1 further including a graft material covering the anchoring stent.

3. The stent device of claim 1 wherein the graft material is a synthetic material selected from the group consisting of polyester, polytetrafluoroethylene, microporous urethane, nylon, and lycra.

4. The stent device of claim 1 wherein the graft material is characterized as having been subjected to a photopolymerization process.

5. The stent device of claim 1 wherein the graft material is a cryogenically preserved biological material.

6. The stent device of claim 1 wherein the graft material is an umbilical cord vein.

7. The stent device of claim 1 wherein the anchoring stent and the scaffolding stent are of Nitinol.

8. The stent device of claim 1 wherein the first and second stents and the connecting wire of the anchoring stent are a unitary member.

9. The stent device of claim 1 wherein the scaffolding stent comprises at least two stents connected together.

10. A method of delivering and deploying a multi-stage stent device in one trip into a vasculature, comprising the steps of:

a) providing a delivery device comprising;

i) a pusher/holder wire having a length sufficient for manipulation from outside the vasculature, wherein the pusher/holder wire has a distal portion provided with a pair of first and second spaced apart stoppers mounted on the pusher/holder wire;

ii) a first sheath having a first diameter;

iii) a second sheath having a second diameter less than the first diameter of the first sheath; and

iv) a catheter having a third diameter less than the first and second diameters, wherein a distal end of the catheter is connected to a proximal end of the second sheath; and

b) positioning a first stent device housed inside the first sheath;

c) positioning a second stent device surrounding the pusher/holder wire and intermediate the first and second spaced apart stoppers;

d) assembling the delivery device by moving the second sheath over the second stent device and supported on at least one of the first and second stoppers and in a movable relationship therewith, and by moving the catheter through the first stent device housed inside the first sheath;

e) moving the delivery device through the vasculature to position the first stent device at a treatment site;

f) moving the first sheath in a proximal direction while the pusher/holder wire and the catheter remain stationary to thereby deploy the first stent device at such time as the first sheath is removed from its housing relationship with the first stent device;

g) moving the pusher/holder wire and the catheter connected to the second sheath in a proximal direction until the second stent device is properly positioned with respect to, and at least partially inside of, the first stent device; and

h) moving the catheter and the associated second sheath in a proximal direction while the pusher/holder wire remains stationary to thereby deploy the second stent device at such time as the second sheath is removed from its housing relationship with the second stent device.

11. The method of claim 10 including providing the first stent device comprising first and second spaced apart stents connected to each other by at least one connecting wire.

12. The method of claim 10 including providing the first stent device having a covering graft material.

13. The method of claim 10 including selecting the graft material from the group consisting of polyester, polytetrafluoroethylene, urethane, nylon, lycra and a veneous material.

14. The method of claim 11 including providing the second stent device having a length such that it fits between the first and second stents of the first stent device.

15. The method of claim 10 including the second stent device comprising at least two stents connected together.

16. The method of claim 10 including providing the pusher/holder wire having flexible distal tip.

17. The method of claim 10 including providing a proximal end of the second sheath surrounded by a distal end of the first sheath in the assembled delivery device.

18. The method of claim 10 wherein the first and second stent device are of Nitinol.

19. The method of claim 10 including providing the first stent device comprising a hollow thermoplastic tube.

20. The method of claim 19 wherein the hollow tube is provided with at least one stent at one of its ends.

21. The method of claim 10 wherein the first stent device and the second stent device are deployed with their respective stents in a non-aligned relationship.

22. The method of claim 10 wherein with the second stent device deployed inside of the first stent device, the combined stent devices exert a radial force of at least about 80% of their combined individual radial forces.