DEVICES AND METHODS FOR CONTROLLING EXPANDABLE PROSTHESES DURING DEPLOYMENT

• US 20090234428A1
• Filed: 05/22/2009
• Published: 09/17/2009
• Est. Priority Date: 06/28/2004
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Karratt, Joseph, Demarais, Denise, Grainger, Jeffry J., Snow, David W.
• Granted Patent: US 8,986,362 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

Prosthesis delivery devices and methods are provided that enable precise control of prosthesis position during deployment. The prosthesis delivery devices may carry multiple prostheses and include deployment mechanisms for delivery of a selectable number of prostheses. Control mechanisms are provided in the prosthesis delivery devices that control either or both of the axial and rotational positions of the prostheses during deployment. This enables the deployment of multiple prostheses at a target site with precision and predictability, eliminating excessive spacing or overlap between prostheses. In particular embodiments, the prostheses of the invention are deployed in stenotic lesions in coronary or peripheral arteries, or in other vascular locations.

Claims

1. A prosthesis delivery catheter for delivering a prosthesis into a vessel, said catheter comprising:

an outer shaft having a distal end, a first lumen, and a substantially inexpandable outer diameter;

a plurality of self-expanding tubular prostheses having a contracted configuration and a radially expanded configuration with an expanded diameter adapted to contact the vessel, the prostheses carried within the first lumen and being adapted to radially expand into the expanded configuration upon deployment from the first lumen, wherein adjacent self-expanding prostheses are unconnected and free of material deployable with the prostheses extending therebetween thereby allowing axial separation of one prosthesis from an adjacent prosthesis in the contracted configuration; and

a control member extending distally from the distal end of the outer shaft and defining an interior communicating with the first lumen for receiving one or more of the prostheses when the prostheses are advanced distally, comprising a plurality of tines arranged in a cylindrical pattern, the tines having an undeflected shape when not engaged by any of the prostheses, the undeflected shape being biased radially inward toward the prostheses and being configured to deflect radially outwardly to at least the expanded diameter of the prostheses when engaged by a first prosthesis during the expansion thereof, the tines being configured to resiliently return to the undeflected shape when the first prosthesis is removed from the interior.

2. The prosthesis delivery catheter of claim 1, wherein the control member comprises a radially distensible elastomeric tube.

3. The prosthesis delivery catheter of claim 1, further comprising:

an inner shaft slidable relative to the outer shaft; and

a nose piece at the distal end of the inner shaft disposed distally of the control member, the nose piece having a proximal opening adapted to receive a distal end of the control member.

4. The prosthesis delivery catheter of claim 3, wherein the control member comprises a plurality of tines arranged in a generally cylindrical pattern, the tines having inwardly-oriented distal tips for positioning in the proximal opening of the nose piece.

5. The prosthesis delivery catheter of claim 1, wherein the control member is adapted to be slidably removed from the prosthesis following the expansion thereof.

6. The prosthesis delivery catheter of claim 1, wherein the prostheses are adapted for deployment in groups of at least two at a single treatment site.

7. The prosthesis delivery catheter of claim 6, wherein each of the prostheses has axially extending elements configured to interleave with axially extending elements on an adjacent prosthesis.

8. The prosthesis delivery catheter of claim 7, wherein the control member is adapted to control expansion of the prostheses such that the axially extending elements remain interleaved when at least two prostheses are deployed adjacent to each other.

9. The prosthesis delivery catheter of claim 1, further comprising a pusher slidably disposed within the first lumen, the pusher engaging at least one of the prostheses to deploy the prostheses from the first lumen.

10. A prosthesis delivery catheter for delivering a prosthesis into a vessel, said catheter comprising:

an outer shaft having a distal end and a first lumen;

a plurality of self-expanding tubular prostheses having a contracted configuration and a radially expanded configuration with an expanded diameter adapted to contact the vessel, the prostheses carried within the first lumen and being adapted to radially expand into the expanded configuration upon deployment from the first lumen, wherein a first prosthesis is axially separable from an adjacent prosthesis in the contracted configuration; and

a control member extending distally from the distal end of the outer shaft and defining an interior communicating with the first lumen for receiving one or more of the prostheses when the prostheses are advanced distally, the control member having an undeflected shape when not engaged by any of the prostheses, the undeflected shape being biased radially inward toward the prostheses and being configured to deflect radially outwardly to at least the expanded diameter of the prostheses when engaged by a prosthesis during the expansion thereof, the control member being configured to resiliently return to the undeflected shape when the prosthesis is removed from the interior,

wherein the control member comprises a plurality of tines arranged in a generally cylindrical pattern, the tines being outwardly deflectable as the prostheses expand, and

wherein the control member further comprises a web extending between the tines.

11. The prosthesis delivery catheter of claim 10, wherein the web is a distensible elastomer.

12. A prosthesis delivery catheter for delivering a prosthesis into a vessel, said catheter comprising:

an outer shaft having a distal end a first lumen, and a substantially inexpandable outer diameter;

a plurality of self-expanding tubular prostheses having a contracted configuration and a radially expanded configuration with an expanded diameter adapted to contact the vessel, the prostheses carried within the first lumen and being adapted to radially expand into the expanded configuration upon deployment from the first lumen, wherein adjacent self-expanding prostheses are unconnected and free of material deployable with the prostheses extending therebetween thereby allowing axial separation of one prosthesis from an adjacent prosthesis in the contracted configuration; and

a control member extending distally from the distal end of the outer shaft and defining an interior communicating with the first lumen for receiving one or more of the prostheses when the prostheses are advanced distally, and having an undeflected shape when not engaged by any of the prostheses, the undeflected shape being biased radially inward toward the prostheses and being configured to deflect radially outwardly to at least the expanded diameter of the prostheses when engaged by a first prosthesis during the expansion thereof, the control member maintaining engagement with each prosthesis until it expands into contact with the vessel wall, the control member being configured to resiliently return to the undeflected shape when the prosthesis is removed from the interior.

13. The prosthesis delivery catheter of claim 12, wherein the control member comprises a plurality of tines arranged in a generally cylindrical pattern, the tines being outwardly deflectable as the prostheses expand.

14. The prosthesis delivery catheter of claim 13, wherein the control member further comprises a web extending between the tines.

15. The prosthesis delivery catheter of claim 14, wherein the web is a distensible elastomer.

16. The prosthesis delivery catheter of claim 12, wherein the control member comprises a radially distensible elastomeric tube.

17. The prosthesis delivery catheter of claim 12, further comprising:

an inner shaft slidable relative to the outer shaft; and

a nose piece at the distal end of the inner shaft disposed distally of the control member, the nose piece having a proximal opening adapted to receive a distal end of the control member.

18. The prosthesis delivery catheter of claim 17, wherein the control member comprises a plurality of tines arranged in a generally cylindrical pattern, the tines having inwardly-oriented distal tips for positioning in the proximal opening of the nose piece.

19. The prosthesis delivery catheter of claim 12, wherein the control member is adapted to be slidably removed from the prosthesis following the expansion thereof.

20. The prosthesis delivery catheter of claim 12, wherein the prostheses are adapted for deployment in groups of at least two at a single treatment site.

21. The prosthesis delivery catheter of claim 20, wherein each of the prostheses has axially extending elements configured to interleave with axially extending elements on an adjacent prosthesis.

22. The prosthesis delivery catheter of claim 21, wherein the control member is adapted to control expansion of the prostheses such that the axially extending elements remain interleaved when at least two prostheses are deployed adjacent to each other.

23. The prosthesis delivery catheter of claim 12, further comprising a pusher slidably disposed within the first lumen, the pusher engaging at least one of the prostheses to deploy the prostheses from the first lumen.