Transluminal methods and devices for closing, forming attachments to, and/or forming anastomotic junctions in, luminal anatomical structures

• US 7,056,325 B1
• Filed: 09/27/2002
• Issued: 06/06/2006
• Est. Priority Date: 06/28/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Machold, Timothy R., Flaherty, J. Christopher, Makower, Joshua, Garibotto, John Thomas, Whitt, Jason Brian
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US10/259,210
• Time in Patent Office: 1,348 Days
• Field of Search: 606/153, 606/154, 606/157
• US Class Current: 606/153
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06047 located at the middle of the needle
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

Methods and apparatus for passing attachment apparatus (e.g., connector devices, staples, etc.) or connector material (e.g., suture thread, wire, cord, filament, monofilament, etc.) into or through the wall of a luminal anatomical structure (e.g., a blood vessel or other anatomical conduit) for the purpose of; i) closing the lumen of the anatomical structure, ii) forming an anastomotic junction between separate anatomical structures (or between approximated segments of the same anatomical structure), and/or iii) attaching an article (e.g., an endoluminal, extraluminal or transluminal graft) or other apparatus to the wall of the anatomical structure.

Claims

1. A method for forming an attachment to, or anastomosis in, the wall of the anatomical structure by placing at least one attachment apparatus in the wall if the anatomical structure, said method comprising the steps of:

A. providing an intraluminal device which comprises;

i.) an elongate catheter which is insertable into the lumen of the anatomical structure;

ii.) an elongate tissue-penetrating member initially disposed within said catheter, said tissue-penetrating member being subsequently advancable from the catheter and at least partially through the wall of the anatomical structure into which said catheter has been advanced, said tissue-penetrating member having a lumen which extends longitudinally through at least a distal portion of the tissue-penetrating member, and an outlet opening formed in the distal end of the tissue-penetrating member in communication with said lumen; and

,

iii.) at least one attachment apparatus comprising an elongate, flexible link having at least first and second engagement members associated with opposite ends thereof, said attachment apparatus including both of said first and second engagement members being initially loaded into the lumen of the tissue penetrating member and incrementally advancable out of the outlet opening in the distal end of the tissue-penetrating member such that the first engagement member may be expelled from the lumen of the tissue penetrating member at a first location and the second engagement member may be expelled from the lumen of the tissue penetrating member at a second location and said link(s) will extend therebetween to form the desired attachment or anastomosis;

B. positioning the catheter within the lumen of the anatomical structure;

C. advancing the tissue penetrating member out of the catheter a first time such that the sharpened distal tip of the tissue penetrating member penetrates at least partially through the wall of the anatomical structure and the outlet opening of the needle becomes situated adjacent said first location;

D. expelling the first engagement member out of the lumen of the tissue penetrating member through the outlet opening in the distal end of the tissue penetrating member such that said first engagement member will engage the wall of the luminal anatomical structure at said first location;

E. retracting the tissue penetrating member into the catheter;

F. repositioning the catheter within the lumen of the anatomical structure;

G. advancing the tissue penetrating member from the catheter a second time, such that the sharpened distal tip of the tissue penetrating member penetrates at least partially through the anatomical structure and the outlet opening becomes situated adjacent said second location;

H. expelling the second engagement member out of the lumen of the tissue penetrating member through the outlet opening in the distal end of the tissue penetrating member such that the second engagement member will engage the wall of the anatomical structure at said second location, and the link portion of said attachment apparatus extends between said first location and said second location.

2. The method of claim 1 wherein the method is performed to attach an article to the wall of the anatomical structure, and wherein the method further comprises the step of:

positioning the article at a desired location adjacent the wall of the anatomical structure, and wherein the catheter-positioning of step B is performed such that the tissue-penetrating member will pass through a portion of the article as well as through the tissue of the anatomical structure wall.

3. The method of claim 1 wherein said method is performed for the purpose of forming an anastomotic junction between two segments of said anatomical structure, and wherein said method further comprises the step of:

approximating the two segments of said anatomical structure and causing the first and second locations to be positioned such that the attachment apparatus will form an anastomosis between the approximated segments of said anatomical structure.

4. The method of claim 1 wherein the first and second engagement members are serially loaded in the lumen of the tissue penetrating member before performance of Step D.

5. The method of claim 4 wherein the first and second engagement members are coupled together while they remain loaded in the lumen of the lumen of the tissue penetrating member and wherein Step D further comprises uncoupling the first engagement member from the second engagement member.

6. The method of claim 1 wherein the anatomical structure comprises a blood vessel.

7. The method of claim 6 wherein at least one of Steps C and G comprises advancing the tissue penetrating member outwardly through the wall of the blood vessel and wherein at least one of Steps D and H comprises expelling the engagement member such that it engages an adventitial surface of the blood vessel.

8. The method of claim 1 wherein said method is performed for the purpose of connecting a first anatomical structure and a second anatomical structure, and wherein said method further comprises the step of:

approximating the first and second anatomical structures and causing the first and second locations to be positioned such that the attachment apparatus will anastomose the first anatomical structure to the second anatomical structure.

9. The method of claim 1 wherein the method is carried out to form an end to end anastomosis between two luminal anatomical structures or between transected ends of the same luminal anatomical structure.