Intraluminal prosthesis attachment systems and methods

• US 8,075,570 B2
• Filed: 11/29/2002
• Issued: 12/13/2011
• Est. Priority Date: 11/28/2001
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Aptus Endosystems Inc. (Medtronic Plc)
• Inventors: Bolduc, Lee, Kaganov, Alan L.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US10/307,226
• Publication Number:
  US 20040093057A1
• Time in Patent Office: 3,301 Days
• Field of Search: 623/1.11, 623/1.23, 227/175.1, 606/140, 606/143, 606/139, 606/142, 604/528
• US Class Current: 606/142
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching

Abstract

Systems and method implant prostheses in the body. The systems and methods provide permanent attachment of the prosthesis in the body. The prosthesis can comprise, e.g., an endovascular graft, which can be deployed without damaging the native blood vessel in either an arterial or a venous system. The endovascular graft can comprise, e.g., a radially expanding vascular stent and/or a stent-graft. The graft can be placed in the vasculature, e.g., to exclude or bridge an aneurysm, for example, an abdominal aortic aneurysms. The graft desirably adapts to changes in aneurysm morphology and repairs the endovascular aneurysm. The fastening systems and methods can be deployed through the vasculature and manipulated from outside the body, to deliver a fastener to attach the graft to the vessel wall.

Claims

1. A system to implant a plurality of single tissue piercing fasteners one-at-a-time to desired fastening surfaces within a targeted endovascular region, the system comprising

a steerable directing device sized and configured to be deployed from a remote access site to a targeted endovascular region, the directing device including

a proximal end sized and configured to be disposed at the remote access site and a distal end sized and configured to be disposed at the targeted endovascular region,

a guide lumen extending between the proximal and distal ends,

a steering control assembly comprising at least one steering wire in the distal end and a control member on the proximal end coupled to the steering wire to serially deflect the distal end toward different desired fastening sites in the targeted endovascular region, and

a stabilization device sized and configured to be deployed when desired to maintain position of the steerable directing device while deflected with respect a desired fastening site,

a plurality of single tissue-piercing fasteners each comprising a body having a distal end for piercing and penetrating tissue in response to an implantation force, the body also having a proximal end,

a fastener attachment assembly separate from the directing device, the fastener attachment assembly including

a catheter body sized and configured to be serially introduced and retrieved by an operator through the guide lumen between the remote access site and the targeted endovascular region,

a drive cable carried at least partially within the catheter body, the drive cable including a distal end comprising a carrier being sized and configured, when the catheter body is retrieved from the targeted endovascular region, to be releasably coupled to the proximal end of a single fastener body, and

an actuator coupled to a proximal end of the drive cable that is operable to drive the carrier to generate the implantation force, the actuator including a sensing mechanism that normally disables operation of the actuator when the catheter body is retrieved from the targeted endovascular region and free of contact with a desired fastening site and that enables operation of the actuator only when the catheter body is introduced through the guide lumen in the targeted endovascular region and a desired degree of contact is sensed between the distal end of the fastener body on the carrier and the desired fastening site that is oriented by deflection of the distal end of the directing device and stabilized by the stabilization device within the targeted endovascular region.

2. A system according to claim 1

wherein the tissue-piercing fastener includes a stop structure associated with the proximal end to prevent over-penetration of the fastener body into tissue.

3. A system according to claim 1

wherein at least a portion of the drive cable is displaced within the catheter body in response to contact between the distal end of the fastener body on the carrier and the desired fastening surface oriented by deflection of the distal end of the directing device and stabilized by the stabilization device within the targeted endovascular region, and

wherein the sensing mechanism is coupled to the drive cable to sense displacement of the drive cable and to enable operation of the actuator when a predefined amount of displacement is sensed.

4. A system according to claim 3

wherein the sensing mechanism comprises a switch having a normally open condition disabling operation of the actuator and a closed condition enabling operation of the actuator, and

wherein the drive cable is coupled to the switch for moving the switch from the open condition toward the closed condition in response to the predefined amount of displacement.

5. A system according to claim 3

wherein the sensing mechanism includes an adjustment element for defining the defined amount of the displacement.

6. A system according to claim 1

wherein the sensing mechanism includes a rod that is displaced within the catheter body in response to contact between the distal end of the fastener body on the carrier and the desired fastening surface oriented by deflection of the distal end of the directing device and stabilized by the stabilization device within the targeted endovascular region, and

wherein the sensing mechanism is coupled to the rod to sense the displacement of the rod and to enable operation of the actuator when a predefined amount of displacement is sensed.

7. A system according to claim 1

wherein the desired fastening surface comprises tissue within the targeted endovascular region.

8. A system according to claim 1

wherein the desired fastening surface comprises a prosthesis located within the targeted endovascular region.