EMERGENCY VASCULAR REPAIR PROSTHESIS DEPLOYMENT SYSTEM

• US 20120165915A1
• Filed: 12/22/2010
• Published: 06/28/2012
• Est. Priority Date: 12/22/2010
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: MELSHEIMER, JEFFRY S., Eells, Robert M., Hoffman, Grant T.
• Granted Patent: US 8,657,866 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/9661 the proximal portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable

Abstract

A deployment device for repair of a transected body vessel is described herein. Device can have a handle and one or more shafts coupled thereto. A prosthesis being retained by a sheath can be coupled to the delivery device. The sheath can have end portions coupled to one or more shafts. Rotation of a shaft can retract a sheath portion away from either end of the prosthesis for expansion thereof prior to the middle of the prosthesis. Continued rotation of a shaft can completely remove the sheath from the prosthesis, so that the prosthesis is fully expanded and couples the first and second vessel portions of the transected vessel together. Prosthesis may be retained by overlapping a tubular sheath and lacing a threading member therethrough. Prosthesis may be retained by a splittable sheath.

Claims

1. A deployment device for a prosthesis to repair a damaged portion of a body vessel, the prosthesis retainable in a compressed configuration by a removable sheath having extended end portions, the device comprising:

a handle portion having a proximal end and a distal end; and

an actuation portion comprising at least one shaft coupled to an actuation member, the at least one shaft coupled to the handle portion, and having a portion coupled to at least one of the extended end portions of said removable sheath,

wherein said removable sheath is retractable in a direction toward a center of the prosthesis away from at least one of a first outer end and a second outer end of said prosthesis, whereby both of the first outer end and the second outer end of said prosthesis are capable of being expanded prior to the expansion of the center of the prosthesis.

2. The device of claim 1, wherein the at least one shaft comprises a first shaft and a second shaft, the first shaft coupled to a first extended end portion of said removable sheath, and the second shaft coupled to a second extended end portion of said removable sheath, wherein, in response to rotation of the first and second shafts by the actuation member, the first extended end portion is retracted and the second extended end portion is retracted from the prosthesis for expansion thereof.

3. The device of claim 2, wherein the at least one shaft further comprises a third shaft and a fourth shaft, and said removable sheath further comprises an overlapping region of longitudinal edges, a first threading member laced through a first portion of the overlapping region, a second threading member laced through a second portion of the overlapping region, wherein the third shaft is coupled to the first threading member, and the fourth shaft is coupled to the second threading member, and in response to rotation of the third and fourth shafts by the actuation member, the first threading member is removable and the second threading members is removable from the respective first and second portions of the overlapping region.

4. The device of claim 3, wherein the first and second shafts are capable of winding the respective first and second extended end portions of the removable sheath there around, and the third and fourth shafts are capable of winding the respective first and second threading members there around.

5. The device of claim 3, wherein one of the first and second shafts and one of the third and fourth shafts form a first pair of shafts, the first pair of shafts configured to cooperatively retract at least one of the removable sheath and the first threading member toward the center of the prosthesis away from the first outer end of said prosthesis.

6. The device of claim 5, wherein the other of the first and second shafts and the other of the third and fourth shafts form a second pair of shafts, the second pair of shafts configured to cooperatively retract at least one of the removable sheath and the second threading member toward the center of the prosthesis away from the second outer end of said prosthesis.

7. The device of claim 6, wherein the actuation portion is configured to rotate the first pair of shafts and the second pair of shafts in sequence.

8. The device of claim 6, wherein the actuation portion is configured to rotate the first pair of shafts and the second pair of shafts simultaneously.

9. The device of claim 2, wherein the removable sheath further comprises at least two segments, and the at least one shaft further comprises a third shaft and a fourth shaft, the first shaft coupled to a first extended end portion of a first segment of the removable sheath, the second shaft coupled to a second extended end portion of the first segment to the removable sheath, the third shaft coupled to a first extended end portion of a second segment of the removable sheath, the fourth shaft coupled to a second extended end portion of the second segment to the removable sheath.

10. The device of claim 9, wherein the first and second segments of said removable sheath form two overlapping regions of longitudinal edges, the device further comprising a first threading member laced through a first length of a first overlapping region, a second threading member laced through a first length of a second overlapping region, a third threading member laced through a second length of the first overlapping region, a fourth threading member laced through a second length of the second overlapping region, wherein each of the threading members is inserted through the respective shafts, and in response to a retraction force on each of the threading members, each of the threading members is removable from the respective first and second overlapping regions.

11. A deployment system for repair of a damaged portion of a body vessel, comprising:

a prosthesis assembly comprising a self-expanding prosthesis having a first outer end, a second outer end, and a middle portion therebetween, and a removable sheath having a tubular intermediate portion configured to retain the prosthesis in a radially compressed configuration, and a first extended end portion and a second extended end portion each extending away from the intermediate portion;

a deployment device comprising a handle portion having a proximal end and a distal end adjacent the prosthesis assembly, and a first shaft and a second shaft coupled to an actuation member, each of the first and second shafts coupled to the handle portion, the first shaft coupled to the first extended end portion of the sheath, the second shaft coupled to the second extended end portion of the sheath,

wherein, in response to rotation of each of the first and second shafts, the first and second extended end portions of the sheath are capable of retraction in a direction toward the middle portion of the prosthesis away from the respective first and second outer ends of the prosthesis, whereby both of the first and second outer ends of said prosthesis are capable of being expanded prior to the expansion of the middle portion of the prosthesis.

12. The system of claim 11, wherein a first length of the sheath proximate the first outer end of the prosthesis is everted in order to direct the first extended end portion toward the first shaft, and a second length of the sheath proximate the second outer end of the prosthesis is everted in order to direct the second extended end portion toward the second shaft.

13. The system of claim 11, wherein the sheath further comprises one or more longitudinal split regions so that the sheath is capable of being split during retraction of the sheath.

14. The system of claim 11, wherein the intermediate portion of the sheath comprises one or more overlapping regions of longitudinal edges, the overlapping region having a series of openings extending therethrough, the prosthesis further comprising one or more threading members laced through the series of openings to couple the overlapping region together.

15. The system of claim 11, wherein the deployment device further comprises an actuation portion coupled to the handle portion, the actuation portion configured to retract the one or more threading members from the series of openings to facilitate expansion of the prosthesis.

16. A method of intraoperatively repairing a transected body vessel having first and second vessel portions with an end opening, comprising:

providing a delivery device including a handle portion and at least one shaft coupled thereto;

providing a prosthesis assembly disposed at an end of the delivery device, the prosthesis assembly comprising a self-expanding prosthesis having first and second outer ends and a middle portion therebetween, and a removable sheath having a tubular intermediate portion retaining the prosthesis in a radially compressed configuration, with at least one extended end portion extending from the intermediate portion, wherein the at least one extended end portion is coupled to the at least one shaft; and

inserting a first length of the prosthesis assembly corresponding to the first outer end of the prosthesis into an end opening of the first vessel portion;

inserting a second length of the prosthesis assembly corresponding to the second outer end of the prosthesis into an end opening of the second vessel portion;

rotating the at least one shaft for removal of a first outer portion of the sheath from the prosthesis in a first direction for expansion of the first outer end of the prosthesis in order to purchase a vessel wall of the first vessel portion, and rotating the at least one shaft for removal of a second outer portion of the sheath from the prosthesis in a second direction, opposite the first direction, for expansion of the second outer end of the prosthesis in order to purchase a vessel wall of the second vessel portion, whereby the prosthesis is in a fully expanded configuration and couples the first and second vessel portions together.

17. The method of claim 16, wherein the at least one shaft further comprises first and second shafts coupled to the handle portion, and the rotating step further comprises rotating the first shaft for removal of the first outer portion of the sheath and for expansion of the first outer end of the prosthesis, and rotating the second shaft for removal of the second outer portion of the sheath and for expansion of the second outer end of the prosthesis.

18. The method of claim 16, wherein the intermediate portion of the sheath further comprises one or more overlapping regions of longitudinal edges, the overlapping region having a series of openings extending therethrough, and one or more threading members laced through the series of openings, the method further comprising the step of rotating the at least one shaft for removal of the threading member from the series of openings to facilitate expansion of the prosthesis.

19. The method of claim 16, wherein the intermediate portion of the sheath further comprises one or more overlapping regions of longitudinal edges, the overlapping region having a series of openings extending therethrough, and one or more threading members laced through the series of openings, the method further comprising the step of retracting the one or more threading members from the series of openings to facilitate expansion of the prosthesis.

20. The method of claim 16, wherein the intermediate portion of the sheath further comprises one or more longitudinal split regions, the method further comprising the step of splitting the sheath along the one or more longitudinal split regions to facilitate expansion of the prosthesis.