Devices, systems, and methods for prosthesis delivery and implantation

• US 20060100686A1
• Filed: 10/20/2005
• Published: 05/11/2006
• 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, Stafford, Joshua, Laroya, Gilbert
• Granted Patent: US 7,637,932 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/0688 Packages or dispensers for surgical staplers
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• 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 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10T 29/49947 : by applying separate fastener

Abstract

Devices, systems, and methods use a catheter device sized and configured for introduction to a targeted site in a hollow body organ or blood vessel. The catheter device includes a first release mechanisms coupled to the prosthesis to secure at least one region of the prosthesis to the catheter shaft, and a second release mechanism coupled to the prosthesis in cooperation with the first release mechanism to prevent full release of the at least one region of the at least one region of the prosthesis from the catheter shaft after actuation of the first release mechanism. A fastening device sized and configured for introduction to the targeted site in the hollow body organ or blood vessel occupied by the catheter device, includes an actuator to deploy a fastener in the at least one region of the prosthesis after actuation of the first release mechanism and before actuation of the second release mechanism.

Claims

1. A system for delivering a prosthesis to a targeted site comprising

a catheter device sized and configured for introduction to a targeted site in a hollow body organ or blood vessel, the catheter device including

a shaft sized and configured to carry the prosthesis a during introduction of the catheter device,

a first release mechanisms coupled to the prosthesis to secure at least one region of the prosthesis to the catheter shaft, and a first actuator to operate the first release mechanism, and

a second release mechanism coupled to the prosthesis in cooperation with the first release mechanism to prevent full release of the at least one region of the at least one region of the prosthesis from the catheter shaft after actuation of the first actuator, whereby actuation of the first actuator partially releases the at least one region of the prosthesis from the catheter shaft at the targeted site without fully releasing the at least one region from the catheter shaft, and a second actuator to operate the second release mechanism to fully release the at least one region of the prosthesis from the catheter shaft, and

a fastening device sized and configured for introduction to the targeted site in the hollow body organ or blood vessel occupied by the catheter device, the fastening device including an actuator to deploy a fastener in the at least one region of the prosthesis after actuation of the first release mechanism and before actuation of the second release mechanism.

2. A system according to claim 1

wherein the second release mechanism comprises at least one stabilizing arm depending from the catheter shaft.

3. A system according to claim 1

wherein the first release mechanism comprises a suture or filament or wire.

4. A system according to claim 1

further including a guide tube for guiding introduction of the fastening device.

5. A system according to claim 4

wherein the guide tube include a mechanism for remotely deflecting the guide tube.

6. A system according to claim 1

further including an interlock mechanism to prevent actuation of the second release mechanism without prior actuation of the first release mechanism.

7. A system according to claim 1

further including a third release mechanism coupled to the prosthesis to release a second region of the prosthesis from the catheter shaft and a third actuator to operate the third release mechanism.

8. A method comprising

positioning a deployment catheter at a targeted site in a hollow body organ or blood vessel, the deployment catheter carrying an expandable endovascular prosthesis,

actuating a first release mechanism on the deployment catheter to allow at least some expansion of at least one region of the prosthesis at the targeted site without fully releasing the one region of the prosthesis from the deployment catheter,

after actuating the first release mechanism, applying a fastener to fasten the at least one region of the prosthesis to the targeted site, and

after applying the fastener, actuating a second release mechanism on the deployment catheter to fully release the at least one region of the prosthesis from the deployment catheter.

9. A method according to claim 8

further comprising, after actuating the first release mechanism but before applying the fastener, adjusting a position of the deployment catheter either longitudinally and/or rotationally.

10. A method according to claim 8

wherein applying a fastener includes deploying a second catheter that includes a fastener deployment mechanism.

11. A method according to claim 10

wherein deploying the second catheter includes use of a guide tube through which the second catheter is introduced.

12. A method according to claim 8

wherein the second release mechanism can be actuated only after actuation of the first release mechanism.

13. A system comprising

a longitudinally compliant prosthesis having a proximal end and a distal end,

a catheter device sized and configured for introduction to a targeted site in a hollow body organ or blood vessel, the first catheter device including

a shaft sized and configured to carry the prosthesis during introduction of the catheter device,

a first release mechanisms coupled to a proximal end of the prosthesis to secure the proximal end the prosthesis to the catheter shaft, and a first actuator to operate the first release mechanism,

a second release mechanism coupled to the proximal end of the prosthesis in cooperation with the first release mechanism to prevent full release of the proximal end of the prosthesis from the catheter shaft after actuation of the first actuator, whereby actuation of the first actuator partially releases the proximal end prosthesis from the catheter shaft at the targeted site without fully releasing the proximal end of the prosthesis from the catheter shaft, and a second actuator to operate the second release mechanism to fully release the proximal end of the prosthesis from the catheter shaft, and

a third release mechamism coupled to the distal end of the prosthesis independent of the first and second release mechanisms and a third actuator to operate the third release mechanism to fully release the distal end of the prosthesis from the catheter shaft, and

a fastening device sized and configured for introduction to the targeted site in the hollow body organ or blood vessel occupied by the catheter device, the fastening device including an actuator to deploy a fastener in the proximal end of the prosthesis after actuation of the first release mechanism and before actuation of the second and third release mechanisms.

14. A system according to claim 13

wherein the second release mechanism comprises at least one stabilizing arm depending from the catheter shaft.

15. A system according to claim 13

wherein the first release mechanism comprises a suture or filament or wire.

16. A system according to claim 13

further including a guide tube for guiding introduction of the fastening device.

17. A system according to claim 16

wherein the guide tube include a mechanism for remotely deflecting the guide tube.

18. A system according to claim 13

further including an interlock mechanism to prevent actuation of the second release mechanism without prior actuation of the first release mechanism.

19. A method comprising

positioning a deployment catheter at a targeted site in a hollow body organ or blood vessel, the deployment catheter carrying an expandable endovascular prosthesis,

actuating a first release mechanism on the deployment catheter to allow at least some expansion of the proximal region of the prosthesis at the targeted site without fully releasing the proximal end of the prosthesis from the deployment catheter,

after actuating the first release mechanism, applying a fastener to fasten the proximal end the prosthesis to the targeted site,

after applying the fastener, actuating a second release mechanism on the deployment catheter to fully release the proximal end of the prosthesis from the deployment catheter, and

after applying the fastener, actuating a third release mechanism on the deployment catheter to fully release the distal end of the prosthesis from the deployment catheter.

20. A method according to claim 19

further comprising, after actuating the first release mechanism, but before actuating either the second or third release mechanism, and also before applying the fastener, adjusting a position of the deployment catheter either longitudinally and/or rotationally.

21. A method according to claim 19

wherein the second release mechanism can be actuated only after actuation of the first release mechanism.