THORACIC DEPLOYMENT DEVICE AND STENT GRAFT

• US 20120010696A1
• Filed: 09/22/2011
• Published: 01/12/2012
• Est. Priority Date: 06/16/2004
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation, Cook Medical Technologies, LLC (Cook Group Incorporated), William A. Cook Australia Pty. Ltd (Cook Group Incorporated)
• Original Assignee: Cleveland Clinic Foundation, Cook Medical Technologies, LLC (Cook Group Incorporated), William A. Cook Australia Pty. Ltd (Cook Group Incorporated)
• Inventors: Greenberg, Roy K., Hartley, David Ernest, Lawrence-Brown, Michael
• Granted Patent: US 8,758,425 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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 2/95 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A stent graft introducer for intraluminal deployment of a stent graft (26), the introducer comprising a stent graft release mechanism (6) to allow partial release of the stent graft (26) when carried on the introducer, whereby control of the stent graft can be maintained while allowing access into the lumen of the stent graft from at least one end of the stent graft. The partial release can comprise partial release of one end of the stent graft.

Claims

1. A stent graft introducer for comprising:

a guide wire catheter extending from a proximal to a distal end,

a nose cone dilator on the proximal end of the guide wire catheter, the nose cone dilator having a proximal end and a distal end and a longitudinal groove therein,

a deployment catheter on the guide wire catheter, the guide wire catheter passing through a lumen in the deployment catheter and the deployment catheter being able to move longitudinally and rotationally with respect to the guide wire catheter,

a handle at the distal end of the deployment catheter;

a distal retention arrangement at the proximal end of the deployment catheter to retain the distal end of a stent graft thereon,

a proximal retention arrangement at the distal end of the nose cone dilator to retain the proximal end of a stent graft thereon,

a release arrangement associated with the handle comprising a distal release arrangement and a proximal release arrangement to separately release the distal retention arrangement and the proximal retention arrangement respectively,

the distal retention arrangement at the proximal end of the deployment catheter comprising a proximally facing capsule for engaging a distally extending exposed stent on a stent graft and a sliding handle mechanism to allow movement of at least part of the deployment catheter independently of movement of the second retention arrangement, the sliding handle mechanism comprising a fixed handle associated with the handle and a sliding handle to which the deployment catheter and the capsule at the proximal end of the deployment catheter are fixed, whereby movement of the sliding handle with respect to the fixed handle withdraws the capsule distally from the exposed stent.

2. A stent graft introducer as in claim 1 wherein the distal release arrangement comprises a distal trigger wire extending from the distal retention arrangement to a distal trigger wire grip on the handle.

3. A stent graft introducer as in claim 2 wherein the distal trigger wire engages with the exposed stent within the capsule and preventing the capsule from being withdrawn from the exposed stent until the distal trigger wire has been removed from the capsule.

4. A stent graft introducer as in claim 1 wherein the proximal retention arrangement at the distal end of the nose cone dilator to retain the proximal end of the stent graft thereon comprises multiple separate fastenings between the stent graft and the proximal release arrangement, the proximal release arrangement including a first proximal trigger wire and a second proximal trigger wire extending from the proximal retention arrangement to respective first and second proximal trigger wire grips on the handle to separately release the proximal multiple separate fastenings.

5. A stent graft introducer as in claim 1 wherein the sliding handle is fixed to the fixed handle by a thumbscrew which must be removed before withdrawal of the capsule.

6. A stent graft introducer as in claim 1 further comprising a non-return mechanism associated with the sliding handle whereby upon complete retraction of the sliding handle it cannot be extended.

7. A stent graft introducer as in claim 1 wherein the fixed handle comprises a handle extension and the sliding handle telescopes over the handle extension, a recess in the handle extension and a thumbscrew in the sliding handle and engaged into the recess in the handle extension, wherein the thumbscrew must be removed before withdrawal of the capsule.

8. A stent graft introducer as in claim 7 wherein the handle extension comprises a longitudinal track, the track including a deeper recess at a distal end thereof and the sliding handle comprises a spring loaded plunger engaged into the track whereby during withdrawal of the capsule the plunger slides along the track and upon complete withdrawal the plunger engages in the deeper recess to prevent re-extension of the sliding handle.

9. A stent graft introducer in combination with a stent graft retained on the stent graft introducer;

the stent graft comprising the stent graft comprising a tubular body of a biocompatible graft material and a plurality of stents therealong to support the tubular body and to define in use a lumen through the stent graft, the stent graft further comprising a distally extending exposed stent;

the stent graft introducer comprising a guide wire catheter extending from a proximal to a distal end, a nose cone dilator on the proximal end of the guide wire catheter, the nose cone dilator having a proximal end and a distal end and a longitudinal groove therein,

a deployment catheter on the guide wire catheter, the guide wire catheter passing through a lumen in the deployment catheter and the deployment catheter being able to move longitudinally and rotationally with respect to the guide wire catheter,

a handle at the distal end of the deployment catheter;

the stent graft being retained on the introducer between the proximal end of the deployment catheter and the distal end of the nose cone dilator;

a distal retention arrangement at the proximal end of the deployment catheter to retain the distal end of a stent graft thereon,

a proximal retention arrangement at the distal end of the nose cone dilator to retain the proximal end of the stent graft thereon,

a release arrangement associated with the handle comprising a distal release arrangement and a proximal release arrangement to separately release the distal retention arrangement and the proximal retention arrangement respectively,

the distal retention arrangement at the proximal end of the deployment catheter comprising a proximally facing capsule for engaging the distally extending exposed stent of the stent graft and a sliding handle mechanism to allow movement of at least part of the deployment catheter independently of movement of the second retention arrangement, the sliding handle mechanism comprising a fixed handle associated with the handle and a sliding handle to which the deployment catheter and the capsule at the proximal end of the deployment catheter are fixed, whereby movement of the sliding handle with respect to the fixed handle withdraws the capsule distally from the exposed stent.

10. A stent graft introducer in combination with a stent graft retained on the stent graft introducer as in claim 9 wherein the distal release arrangement comprises a distal trigger wire extending from the distal retention arrangement to a distal trigger wire grip on the handle,

the distal trigger wire engaging with the exposed stent within the capsule and preventing the capsule from being withdrawn from the exposed stent until the distal trigger wire has been removed from the capsule,

a proximal retention arrangement at the distal end of the nose cone dilator to retain the proximal end of the stent graft thereon and an associated proximal release arrangement, the proximal retention arrangement at the proximal end of the stent graft including multiple separate fastenings between the stent graft and the proximal release arrangement, the proximal release arrangement including a first proximal trigger wire and a second proximal trigger wire extending from the proximal retention arrangement to respective first and second proximal trigger wire grips on the handle to separately release the proximal multiple separate fastenings, and

the first proximal trigger wire grip, the second proximal trigger wire grip and the distal trigger wire grip being arranged on the handle so that they can only be released in a selected order.

11. A stent graft introducer in combination with a stent graft retained on the stent graft introducer as in claim 9 further comprising diameter reducing ties associated with the stent graft retained on the introducer and the handle including a release arrangement for the diameter reducing ties and wherein the stent graft comprises at least one fenestration whereby when the stent graft is deployed in a body lumen fluid communication can occur between the lumen of the stent graft and a branch artery of the lumen through the fenestration.

12. A stent graft introducer in combination with a stent graft retained on the stent graft introducer as in claim 9 further comprising an indwelling catheter extending from a distal end of the introducer to a proximal end of the introducer and passing through the stent graft when retained on the introducer.

13. A stent graft introducer in combination with a stent graft retained on the stent graft introducer as in claim 12 wherein the indwelling catheter extends through the deployment catheter to the nose cone dilator to be received in a groove thereon.

14. A stent graft introducer in combination with a stent graft retained on the stent graft introducer as in claim 13 wherein the stent graft has at least one fenestration whereby when the stent graft is deployed in a body lumen fluid communication can occur between the lumen of the stent graft and a branch artery of the lumen through the fenestration.

15. A stent graft introducer in combination with a stent graft retained on the stent graft introducer as in claim 14 wherein the indwelling catheter extends through the fenestration.

16. A stent graft introducer as in claim 9 wherein the sliding handle is fixed to the fixed handle by a thumbscrew which must be removed before withdrawal of the capsule.

17. A stent graft introducer as in claim 9 further comprising a non-return mechanism associated with the sliding handle whereby upon complete retraction of the sliding handle it cannot be extended.

18. A stent graft introducer as in claim 9 wherein the fixed handle comprises a handle extension and the sliding handle telescopes over the handle extension, a recess in the handle extension and a thumbscrew in the sliding handle and engaged into the recess in the handle extension, wherein the thumbscrew must be removed before withdrawal of the capsule.

19. A stent graft introducer as in claim 18 wherein the handle extension comprises a longitudinal track, the track including a deeper recess at a distal end thereof and the sliding handle comprises a spring loaded plunger engaged into the track whereby during withdrawal of the capsule the plunger slides along the track and upon complete withdrawal the plunger engages in the deeper recess to prevent re-extension of the sliding handle.