Split sheath deployment system

• US 8,518,098 B2
• Filed: 02/16/2007
• Issued: 08/27/2013
• Est. Priority Date: 02/21/2006
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Roeder, Blayne A., Leewood, Alan R.
• Primary Examiner(s): Hughes, S. Thomas
• Assistant Examiner(s): SZPIRA, JULIE ANN
• Application Number:
  US11/707,448
• Publication Number:
  US 20070233222A1
• Time in Patent Office: 2,384 Days
• Field of Search: 623/1.11, 623/17.13, 606/108
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 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 2002/041 Bile ducts
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets

Abstract

A device for delivering and deploying a radially expandable prosthesis is disclosed and comprises a proximal prosthesis release mechanism having a first resistance and a distal prosthesis release mechanism having a second resistance. The device further comprises an actuation mechanism for actuating the distal and proximal release mechanisms in a single coordinated movement and a biasing compensator for regulating the relationship between the first resistance and the second resistance. Additional aspects of the invention include devices and methods for delivering and deploying a radially expandable prosthesis.

Claims

1. A device for delivering and deploying a radially expandable prosthesis, the device comprising:

a proximal release mechanism comprising a proximal sheath radially disposed over a proximal portion of a prosthesis, wherein the proximal sheath is slidable proximally relative to the prosthesis to release the proximal portion of the prosthesis, the proximal release mechanism comprising a first resistance;

a distal release mechanism comprising a distal sheath radially disposed over a distal portion of the prosthesis, wherein the distal sheath is slidable distally relative to the prosthesis to release the distal portion of the prosthesis, the distal release mechanism comprising a second resistance;

an actuation mechanism for actuating the proximal and distal release mechanisms in a single coordinated movement; and

a biasing compensator having a longitudinally-directed biasing force acting directly on at least one of the proximal sheath and the distal sheath, whereby the biasing compensator requlates the relationship between the first resistance and the second resistance.

2. The device according to claim 1 wherein at least one of the proximal and distal release mechanisms comprises the biasing compensator.

3. The device according to claim 1 wherein the biasing compensator comprises a spring.

4. The device according to claim 3 wherein the biasing compensator comprises a compression spring.

5. The device according to claim 3 wherein the biasing compensator comprises a tension spring.

6. The device according to claim 1 wherein the biasing compensator comprises a bellows.

7. The device according to claim 1 wherein the biasing compensator comprises a compressible gasket.

8. The device according to claim 1 wherein the device comprises a plurality of biasing elements, each of the distal and proximal release mechanisms including at least one of the plurality of biasing elements.

9. The device according to claim 1 further comprising a limiting member for limiting the displacement of at least one of the proximal sheath and the distal sheath.

10. The device according to claim 1 wherein the biasing compensator increases at least one of the first resistance and the second resistance.

11. The device according to claim 10 wherein the biasing compensator decreases the other of the second resistance and the first resistance.

12. The device according to claim 1 wherein the biasing compensator decreases at least one of the first resistance and the second resistance.

13. The device according to claim 1 wherein the biasing compensator comprises at least one compression spring and at least one tension spring.

14. The device according to claim 13, wherein the at least one compression spring is in series with the at least one tension spring.

15. A device for delivering and deploying a radially expandable prosthesis, the device comprising:

a first elongate member comprising a lumen and having a radially expandable prosthesis disposed over a distal portion of the first elongate member;

a second elongate member slidably disposed within the lumen of the first elongate member and comprising a distal sheath for releasably retaining a distal portion of the prosthesis, wherein the delivery and deployment device has a distal release resistance;

a third elongate member comprising a lumen, the third elongate member slidably disposed over the first elongate member and comprising a proximal sheath for releasably retaining a proximal portion of the prosthesis, wherein the delivery and deployment device has a proximal release resistance;

an actuation mechanism for moving the second elongate member distally relative to the first elongate member and the third elongate member proximally relative to the first elongate member to release the distal and the proximal portions of the prosthesis in a single coordinated movement; and

a biasing compensator disposed between the proximal end of the second elongate member and the proximal end of the third elongate member, the biasing compensator having a longitudinally-directed biasing force for regulating the relationship between the distal release resistance and the proximal release resistance.

16. The device according to claim 15 wherein the biasing compensator is selected from the group consisting of a spring, a bellows, and a compressible gasket.

17. The device according to claim 15 wherein the biasing compensator is directly connected to at least one of the second elongate member and the third elongate member.

18. The device according to claim 15 wherein the delivery and deployment device comprises a plurality of biasing elements, one or more biasing element being connected to each of the second and third elongate members, the biasing elements selected from the group consisting of a spring, a bellows, and a compressible gasket.

19. The device according to claim 15 further comprising a limiting member for limiting the displacement of at least one of the proximal sheath and the distal sheath.

20. A device for delivering and deploying a radially expandable prosthesis, the device comprising:

a proximal release mechanism comprising a proximal sheath radially disposed over a proximal portion of a prosthesis, wherein the proximal sheath is slidable proximally relative to the prosthesis to release the proximal portion of the prosthesis, the proximal release mechanism comprising a first resistance;

a distal release mechanism comprising a distal sheath radially disposed over a distal portion of the prosthesis, wherein the distal sheath is slidable distally relative to the prosthesis to release the distal portion of the prosthesis, the distal release mechanism comprising a second resistance;

an actuation mechanism for actuating the proximal and distal release mechanisms in a single coordinated movement; and

a longitudinally compressible biasing compensator acting directly on at least one of the proximal sheath and the distal sheath, whereby the biasing compensator regulates the relationship between the first resistance and the second resistance.

21. A device for delivering and deploying a radially expandable prosthesis, the device comprising:

a delivery catheter having a proximal end and a distal end;

a radially expandable prosthesis disposed over a distal end portion of the delivery catheter;

a proximal release mechanism comprising a proximal sheath disposed over and releasably retaining a proximal portion of the prosthesis, the proximal release mechanism comprising a first resistance;

a distal release mechanism comprising a distal sheath disposed over and releasably retaining a distal end portion of the prosthesis, the distal release mechanism comprising a second resistance;

an actuation mechanism disposed at a proximal end portion of the delivery catheter and comprising a first handle portion coupled to the proximal release mechanism and a second handle portion coupled to the distal release mechanism, wherein sliding the first handle portion with respect to the second handle portion actuates the proximal and distal release mechanisms at the same time;

the actuation mechanism further comprising a biasing compensator having a longitudinally-directed biasing force acting on at least one of the proximal sheath and the distal sheath, whereby the biasing compensator regulates the relationship between the first resistance and the second resistance.