Graft deployment assist tool

• US 8,419,783 B2
• Filed: 07/07/2010
• Issued: 04/16/2013
• Est. Priority Date: 07/07/2010
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Frye, Mark R., Moore, William F.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/831,725
• Publication Number:
  US 20120010692A1
• Time in Patent Office: 1,014 Days
• Field of Search: 623/1.11, 6041032-1035, 606/191, 128/898
• US Class Current: 623/1.11
• 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

Abstract

A delivery system for a medical device may include a sheath, a catheter slideably disposed within the sheath, and a hemostatic device comprising a housing disposed around and sealingly engaged with the sheath by a first seal. A sleeve is slideably coupled to the catheter and comprises a second seal sealingly engaging the catheter. The sleeve is movable between a first position, in which the sleeve is disposed outside of the housing and the first seal is sealingly engaged with an outer surface of the catheter, and a second position in which at least a portion of the sleeve is disposed within the housing between an inner surface of the housing and the outer surface of the catheter, wherein, in the second position, the first seal is sealingly engaged with an outer surface of the sleeve and the second seal is sealingly engaged with the outer surface of the catheter.

Claims

1. A system for delivering and deploying an expandable prosthesis comprising:

a sheath having a proximal end, a distal end, and a lumen extending between the proximal and distal ends and defining an inner surface;

a delivery catheter slideably disposed within the lumen and having an outer surface in frictional contact with the inner surface of the sheath lumen;

an expandable prosthesis disposed on a distal portion of the delivery catheter and within the lumen of the sheath;

a hemostatic device comprising a housing connected to the proximal end of the sheath and a first seal disposed within the housing and sealingly engaging the delivery catheter; and

a deployment assist device comprising a sleeve and a second seal disposed within the sleeve that is adapted to sealingly engage the catheter,

the deployment assist device being movable between a first position in which the sleeve is disposed outside of the hemostatic device housing and the first seal is sealingly engaged with an outer surface of the catheter effecting a first frictional resistance between the housing and the catheter, and a second position in which at least a portion of the sleeve is disposed within the housing between an inner surface of the housing and the outer surface of the catheter,

wherein, in the second position, the first seal is sealingly engaged with an outer surface of the sleeve and the second seal is sealingly engaged with the outer surface of the catheter and effecting a second frictional resistance between the deployment assist device and the catheter; and

wherein the second frictional resistance is less than the first frictional resistance between the housing and the catheter, thereby reducing a force necessary to effect relative movement between the sheath and the catheter.

2. A system for delivering and deploying a medical device comprising:

a housing comprising a first seal;

a catheter having an outer surface and slideably extending through the housing;

a sleeve comprising a second seal;

the sleeve being movable between a first position in which the sleeve is disposed outside of said housing and a second position in which at least a portion of the sleeve is disposed within the housing between an inner surface of the housing and the outer surface of the catheter;

wherein when the sleeve is in the first position the first seal of the housing is sealingly engaged with the outer surface of the catheter and effects a first frictional resistance between the housing and the catheter, and when the sleeve is in the second position the first seal of the housing is sealingly engaged with an outer surface of the sleeve and the second seal of the sleeve is sealingly engaged with at least a portion of the outer surface of the catheter;

wherein the second seal of the sleeve effects a second frictional resistance between the sleeve and the catheter, the second frictional resistance being less than the first frictional resistance.

3. The system of claim 2, further comprising a sheath having a lumen extending along a central axis thereof, the catheter being disposed within the lumen, wherein the housing is disposed around and connected to at least a portion of the sheath.

4. The system of claim 3, wherein a force required to move the sheath relative to the catheter when the sleeve is in the second position is less than a force required to move the sheath relative to the catheter when the sleeve is in the first position.

5. The system of claim 4, wherein, when the sleeve is in the second position, the force required to move the sheath relative to the catheter is reduced by 10% or more.

6. The system of claim 4, wherein, when the sleeve is in the second position, the force required to move the sheath relative to the catheter is reduced by 25% or more.

7. The system of claim 4, wherein, when the sleeve is in the second position, the force required to move the sheath relative to the catheter is reduced by 50% or more.

8. The system of claim 3, further comprising an expandable prosthesis disposed within the lumen of said sheath.

9. The system of claim 3, where the catheter has an outer diameter that approximates an inner diameter of the lumen of the sheath.

10. The system of claim 2, wherein the sleeve comprises a lubricious material.

11. The system of claim 10, wherein the sleeve comprises Teflon.

12. The system of claim 2, wherein the sleeve comprises a tapered end.

13. The system of claim 2, wherein the first seal of said housing comprises at least one disk valve.

14. The system of claim 13, wherein the at least one disk valve comprises a stretchable opening having a diameter of 1 mm or less.

15. The system of claim 14, wherein the at least one disk valve comprises a stretchable opening having a diameter of 0.1 mm or less.

16. The system of claim 2, wherein the first seal comprises a plurality of disk valves.

17. The system of claim 3, wherein an inner surface of the sheath and the outer surface of the catheter are in frictional engagement with each other.

18. The system of claim 2, wherein the housing comprises an interlocking mechanism that reversibly interlocks the housing in relation to the sleeve to limit relative movement therebetween.

19. The system of claim 2 wherein when said sleeve is in the second position the sleeve is attached to at least a portion of the housing.

20. The system of claim 19, where the catheter comprises an increased diameter portion disposed distally of the sleeve in the second position, the increased diameter portion engageable with said sleeve for detaching the sleeve from the housing when the catheter is withdrawn from the sheath.

21. A method of reducing a force necessary to effect movement between a housing and a catheter the method comprising:

providing a delivery device;

the delivery device comprising a housing and a catheter slideably extending through the housing, the housing comprising a first seal that exerts a first sealing force against an external surface of the catheter that effects a first frictional resistance to relative movement between the catheter and the housing; and

advancing a sleeve over the catheter and through the first seal of the housing, whereby the first seal is decoupled from the catheter and sealingly engages an outer surface of the sleeve, the sleeve at least partially isolating the catheter from the first sealing force,

wherein the sleeve comprises a second seal that applies a second sealing force against at least a portion of the external surface of the catheter that effects a second frictional resistance to relative movement between the catheter and the housing, the second frictional resistance being less than the first frictional resistance.