Proximal release delivery system

• US 8,986,363 B2
• Filed: 12/20/2010
• Issued: 03/24/2015
• Est. Priority Date: 12/30/2009
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: McHugo, Vincent, O'Sullivan, Donagh
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): LOUIS, RICHARD G
• Application Number:
  US12/973,311
• Publication Number:
  US 20120053671A1
• Time in Patent Office: 1,555 Days
• Field of Search: 606/108, 623/1.11, 623/1.12, 623/1.23, 604507-508, 604/51, 744/22, 74 8917- 8919, 74498-500
• 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
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A delivery device for proximally releasing an expandable prosthesis and method of use thereof are described. The delivery device comprises an introducer sheath that is capable of distally advancing relative to the endoprosthesis to thereby expose the endoprosthesis from a proximal end thereof. The device is also capable of resheathing over the prosthesis in a proximal direction. The device comprises a drive pulley that can engage a particular gear set to axially move the introducer sheath and proximally release the prosthesis. The drive pulley can also engage another gear set to resheath the introducer sheath and recapture the prosthesis between the inner catheter and the introducer sheath. A directional switch enables the device to operate between the two modes.

Claims

1. A device for deploying an intraluminal device, comprising:

a gear mechanism comprising a first gear set, a second gear set, a drive shaft, and a main drive gear affixed to the drive shaft, the first gear set comprising a first drive gear, the second gear set comprising a second drive gear, wherein the first drive gear and the second drive gear are drivingly coupled to the drive shaft via one-directional roller clutch bearings, the one-directional roller clutch bearings configured to drive the first and second drive gear when the drive shaft is rotated in one of clockwise and counter-clockwise directions;

a trigger comprising a rack engaging the main drive gear, the trigger being reciprocally movable to rotationally drive the main drive gear and the drive shaft;

a drive pulley adapted to be alternatively mechanically coupled to one of the first gear set and the second gear set;

an introducer sheath operably connected to the drive pulley; and

an expandable prosthesis constrained within the introducer sheath,

wherein the sheath is movable in a distal direction relative to the prosthesis when the drive pulley is mechanically coupled to the first gear set so as to release the prosthesis from a proximal end thereof, and further wherein the sheath is retractable in a proximal direction relative to the prosthesis when the drive pulley is mechanically coupled to the second gear set so as to resheath over the prosthesis.

2. The device of claim 1, further comprising an inner elongate member, wherein the prosthesis is disposed over the inner elongate member along a distal portion thereof.

3. The device of claim 2, further comprising a belt coupled to the drive pulley, the belt being disposed within a housing of the device.

4. The device of claim 3, wherein the belt rotates in a first direction when the drive pulley is mechanically coupled to the first gear set, and further wherein the belt rotates in a second direction when the drive pulley is mechanically coupled to the second gear set.

5. The device of claim 3, further comprising an inner cannula extending within the inner elongate member, the inner cannula having a proximal end mechanically coupled to the belt and a distal end operably connected to the introducer sheath.

6. The device of claim 2, further comprising a means for securing the prosthesis to the inner elongate member during axial movement of the sheath.

7. The device of claim 6, wherein the means for securing the prosthesis to the inner elongate member is configured to distally reposition the prosthesis after being expanded.

8. The device of claim 4, wherein the sheath releases a proximal portion of the prosthesis from within the sheath when the belt rotates in the first direction, and further wherein the sheath resheaths over the prosthesis when the belt rotates in the second direction.

9. The device of claim 1, further comprising an atraumatic sheath overlying the introducer sheath.

10. The device of claim 1, wherein the introducer sheath further comprises an inner cannula, the inner cannula extending through a lumen of the inner elongate member and terminating as a distal tip of the device.

11. A device for delivering an intraluminal device, comprising:

a housing comprising;

a gear and pulley mechanism comprising a first gear set and a second gear set, the first gear set and the second gear sets each being coupled to a drive shaft via on-directional roller clutch bearings, the one-directional roller clutch bearings configured to drive the first gear set when the drive shaft is rotated in one of the clockwise and counter-clockwise directions, and further configured to drive the second gear set when the drive shaft is rotated in the other of the clockwise and counter-clockwise directions;

a trigger comprising a rack engaging the main drive gear, the trigger being reciprocally movable to rotationally drive the drive shaft; and

a drive pulley adapted to be alternatively mechanically coupled to one of the first gear set and the second gear set,

an elongate member fixably connected to a distal end of the housing;

an expandable prosthesis having a first proximal end and a first distal end, the prosthesis mounted over a distal portion of the inner elongate member;

a stabilizing assembly for securing the first distal end of the prosthesis to the inner elongate member; and

an introducer sheath axially movable over the prosthesis, the sheath having a second distal end positioned distal to the first distal end of the prosthesis and a second proximal end positioned proximal to the first proximal end of the prosthesis, wherein the sheath is operably connected to the drive pulley so as to allow the second proximal end of the sheath to slidably advance distally relative to the first proximal end of the prosthesis to thereby expose a proximal portion of the prosthesis.

12. The device of claim 11, further wherein the sheath is configured to retract proximally to a position where the second proximal end of the introducer sheath is aligned or disposed proximal relative to the first proximal end of the prosthesis to resheath the proximal portion of the prosthesis.

13. The device of claim 11, wherein the stabilizing assembly comprises a retaining loop assembly and a lockwire.

14. The device of claim 13, wherein the lockwire is disposed within a slot of a retaining collar portion affixed to the elongate member.

15. The device of claim 13, wherein the lockwire, the retaining loop wire, and a strut of the prosthesis interlock with each other at a predetermined location to define an anchorage point.

16. The device of claim 11, wherein the introducer sheath comprises at least one radiopaque marker affixed to a proximal end of the introducer sheath.

17. A device for delivering an intraluminal device comprising:

a first gear set and a second gear set each being coupled to a drive shaft via on-directional roller clutch bearings, the one-directional roller clutch bearings configured to drive the first gear set when the drive shaft is rotated in one of the clockwise and counter-clockwise directions, and drive the second gear set when the drive shaft is rotated in the other of the clockwise and counter-clockwise directions;

a trigger comprising a rack engaging the main drive gear, the trigger being reciprocally movable to rotationally drive the drive shaft;

a drive pulley adapted to be alternatively mechanically coupled to the first gear set and the second gear set;

a belt coupled to the drive pulley;

an introducer sheath mechanically coupled to the belt; and

an expandable prosthesis constrained within the introducer sheath, wherein the belt is configured to rotate in a clockwise direction when the drive pulley is mechanically coupled to the first gear set to distally advance the sheath beyond a proximal end of the prosthesis so as to release a proximal portion of the prosthesis from within the sheath, and further wherein the belt is configured to rotate in a counterclockwise direction when the drive pulley is mechanically coupled to the second gear set to proximally retract the sheath over the prosthesis.

18. The device of claim 17, wherein the belt is affixed to a shuttle that is axially movable therealong.

19. The device of claim 18, the introducer sheath further comprising an inner cannula, the inner cannula proximally extending from a distal tip of the device to the shuttle.

20. The device of claim 19, wherein the inner cannula axially extends within a luminal space defined by an elongate member.