Catheter-based fastener implantation apparatus and methods with implantation force resolution

• US 7,491,232 B2
• Filed: 09/24/2003
• Issued: 02/17/2009
• Est. Priority Date: 09/18/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Aptus Endosystems Inc. (Medtronic Plc)
• Inventors: Parodi, Juan C., Bolduc, Lee
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T.
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US10/669,881
• Publication Number:
  US 20040127916A1
• Time in Patent Office: 1,973 Days
• Field of Search: 623/1.36, 623/1.11
• US Class Current: 623/1.36
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/2905 flexible
• 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 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2002/065 Y-shaped blood vessels

Abstract

Apparatus and methods implant a fastener in a targeted body region, e.g., a hollow body cavity or an intraluminal space. The apparatus and methods deploy in the targeted body region a fastener attachment assembly that carries an actuated member. The actuated member is selectively operable to generate an implantation force to implant a fastener into tissue within the targeted body region. The fastener can be implanted, e.g., to secure a prosthesis, e.g., an endovascular graft. The systems and apparatus apply a resolution force at or near the actuated member, thereby making possible a stable and dependable catheter-based fastening platform.

Claims

1. A method for repairing a diseased or damaged section of an aorta comprising

(i) providing a system comprising

at least one tissue-piercing fastener having a sharpened distal tip for piercing and penetrating tissue,

a fastener attachment assembly sized and configured to be deployed from a remote access site to a targeted endovascular region, the fastener attachment assembly including

an intraluminal directing device defining an access path and including a deflectable distal region, and

an intraluminal fastener applier separate from the intraluminal directing device and being sized and configured for advancement into the intraluminal directing device along the access path and retrieval from the intraluminal directing device along the access path, the intraluminal fastener applier including an actuated member that is selectively operable to generate an implantation force in an implantation force direction to implant the tissue-piercing fastener by causing the sharpened distal tip to pierce and penetrate the tissue in the targeted endovascular region, and

means associated with the fastener attachment assembly for applying a resolving force in a direction different than the implantation force direction within the targeted endovascular region to resolve at least a portion of the implantation force,

(ii) first, introducing the intraluminal directing device separately from intraluminal fastener applier from a remote access site to a location within a prosthesis that has been deployed at a target site in an aorta where the diseased or damaged section exists;

(iii) establishing the access path to a desired fastening site on the prosthesis by manipulating the intraluminal directing device within the prosthesis to orient the distal region with respect to the desired fastening site;

(iv) and then advancing the intraluminal fastener applier from the remote access site into the intraluminal directing device along the access path to the desired fastening site;

(v) anchoring the prosthesis by operating the actuated member to generate an implantation force to implant the tissue-piercing fastener into tissue at the desired fastening site while the means applies a resolving force to resolve within the targeted site within an aorta at least a portion of the implantation force,

(vi) and then separating the intraluminal fastener applier from the intraluminal directing device by retrieving the intraluminal fastener applier from the intraluminal directing device along the access path back to the remote access site.

2. A method according to claim 1

wherein (iii) includes rotating the intraluminal directing device and/or deflecting the distal region.

3. A method according to claim 1

wherein the prosthesis includes at least one self-expanding scaffold, and

wherein (ii) comprises releasing the prosthesis from constraint to permit the at least one scaffold of the prosthesis to self-expand at the target site.

4. A method according to claim 1

wherein the prosthesis includes at least one malleable scaffold, and

wherein (ii) comprises applying a radially expansive force within the prosthesis to cause expansion of the at least one scaffold.

5. A method according to claim 1

wherein the intraluminal directing device includes a passage that defines the access path,

wherein (iv) includes advancing the intraluminal fastener applier from the remote access site into the intraluminal directing device through the passage to the desired fastening site, and

wherein (vi) includes separating the intraluminal fastener applier from the intraluminal directing device by retrieving the intraluminal fastener applier from the intraluminal directing device through the passage back to the remote access site.

6. A method according to claim 5

wherein the passage comprises an interior lumen.

7. A method according to claim 1

further including, after (vi), (vii) loading at the remote access site another tissue-piercing fastener having a sharpened distal tip for piercing and penetrating tissue on the actuated member.

8. A method according to claim 7

further including repeating (iv), then (v), then (vi), and then (vii) until a desired number of tissue-piercing fasteners are implanted.

9. A method for repairing a diseased or damaged section of an aorta comprising

(i) providing a system comprising

at least one tissue-piercing fastener having a sharpened distal tip for piercing and penetrating tissue,

a fastener attachment assembly sized and configured to be deployed from a remote access site to a targeted endovascular region, the fastener attachment assembly including

an intraluminal directing device defining an access path and including a deflectable distal region, and

an intraluminal fastener applier separate from the intraluminal directing device and being sized and configured for advancement into the intraluminal directing device along the access path and retrieval from the intraluminal directing device along the access path, the intraluminal fastener applier including an actuated member that is selectively operable to generate an implantation force in an implantation force direction to implant the tissue-piercing fastener by causing the sharpened distal tip to pierce and penetrate the tissue in the targeted endovascular region, and

means associated with the fastener attachment assembly for applying a resolving force in a direction different than the implantation force direction within the targeted endovascular region to resolve at least a portion of the implantation force,

(ii) first, introducing the intraluminal directing device separately from intraluminal fastener applier from a remote access site to a location within a prosthesis that has been deployed at a target site in an aorta where the diseased or damaged section exists, thereby establishing an access path;

(iii) and then advancing the intraluminal fastener applier from the remote access site into the intraluminal directing device along the access path;

(iv) anchoring the prosthesis by manipulating the intraluminal directing device within the prosthesis to orient the distal region with respect to the desired fastening site and by operating the actuated member to generate an implantation force to implant the tissue-piercing fastener into tissue at the desired fastening site while the means applies a resolving force to resolve within the targeted site within an aorta at least a portion of the implantation force,

(v) and then separating the intraluminal fastener applier from the intraluminal directing device by retrieving the intraluminal fastener applier from the intraluminal directing device along the access path back to the remote access site.

10. A method according to claim 9

wherein (iv) includes rotating the intraluminal directing device and/or deflecting the distal region.

11. A method according to claim 9

wherein the prosthesis includes at least one self-expanding scaffold, and

wherein (ii) comprises releasing the prosthesis from constraint to permit the at least one scaffold of the prosthesis to self-expand at the target site.

12. A method according to claim 9

wherein the prosthesis includes at least one malleable scaffold, and

wherein (ii) comprises applying a radially expansive force within the prosthesis to cause expansion of the at least one scaffold.

13. A method according to claim 9

wherein the intraluminal directing device includes a passage that defines the access path,

wherein (iii) includes advancing the intraluminal fastener applier from the remote access site into the intraluminal directing device through the passage to the desired fastening site, and

wherein (v) includes separating the intraluminal fastener applier from the intraluminal directing device by retrieving the intraluminal fastener applier from the intraluminal directing device through the passage back to the remote access site.

14. A method according to claim 13

wherein the passage comprises an interior lumen.

15. A method according to claim 9

further including, after (v), (vi) loading at the remote access site another tissue-piercing fastener having a sharpened distal tip for piercing and penetrating tissue on the actuated member.

16. A method according to claim 15

further including repeating (iii), then (iv), then (v), and then (vi) until a desired number of tissue-piercing fasteners are implanted.