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

• US 6,491,707 B2
• Filed: 07/18/2001
• Issued: 12/10/2002
• Est. Priority Date: 06/28/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Machold, Timothy R., Flaherty, J. Christopher, Makower, Joshua, Whitt, Jason Brian, Garibotto, John Thomas
• Primary Examiner(s): Calvert, John J.
• Assistant Examiner(s): Muromoto, Jr., Robert H.
• Application Number:
  US09/908,337
• Publication Number:
  US 20010039426A1
• Time in Patent Office: 510 Days
• Field of Search: 606/139, 606/140, 606/142, 606/144, 606/148, 606/158, 606/190, 606/151, 606/157, 606/141, 606/153, 606/155, 606/213
• US Class Current: 606/157
• 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 or connector material into or through the wall of a luminal anatomical structure for the purpose of, closing the lumen of the anatomical structure, forming an anastomotic junction between separate anatomical structures or between approximated segments of the same anatomical structure, and/or attaching an article, or other apparatus to the wall of the anatomical structure.

Claims

1. A device for passing a connector material through the wall of a luminal anatomical structure, said device comprising:

an elongate catheter which is advancable into the lumen of the anatomical structure;

a tissue penetrating member which is moveably disposed within said catheter, said tissue-penetrating member being advancable in at least one direction to create a puncture tract through a portion of the wall of the luminal anatomical structure into which the catheter has been inserted;

a length of connector material attached to said tissue penetrating member so as to be drawn by the tissue-penetrating member through the puncture tract which it creates through a portion of the wall of the luminal anatomical structure.

2. The device of claim 1 wherein the catheter is pliable.

3. The device of claim 1 wherein the catheter is rigid.

4. The device of claim 1 wherein the connector material is selected from the group of connector materials comprising:

a. suture thread;

b. wire;

c. strand of natural material;

d. strand of synthetic material;

e. filament of natural material;

f. filament of synthetic material;

g. monofilament of natural material;

h. monofilament of synthetic material;

i. absorbable material; and

,

j. nonabsorbable material.

5. An inboard-penetrating-member embodiment of the device of claim 1 wherein:

the catheter has a proximal end, a distal end, an outer surface, a side opening formed at a first location thereon, a tissue-receiving area formed within said catheter body and into which a first portion of the wall of the luminal anatomical structure may intrude through said side opening; and

a lumen which extends through the tissue-receiving area; and

,

said tissue penetrating member is moveably disposed within the lumen of said catheter so as to be passable in at least one direction through the tissue-receiving area to form a puncture tract through the portion of the wall of the anatomical structure which has been caused to intrude into the tissue-receiving area, and to thereby draw said connector material through that puncture tract.

6. The device of claim 5 wherein said catheter further comprises;

a lateral pressure-exerting member extendable laterally from the catheter to drive the catheter laterally in an opposite direction, thereby pressing the side opening of the catheter against the wall of the anatomical structure such that the first portion of the wall of the anatomical structure will intrude into the tissue-receiving area.

7. The device of claim 5 wherein a cross-member is formed within the catheter, said cross-member extending transversely across the lumen of the catheter at a location adjacent said side opening, said tissue-receiving area being located space between said cross-member and said side opening;

and, wherein said tissue-penetrating member comprises;

a dual-tipped member having sharpened first and second ends and having said connector material attached thereto at a location between said sharpened first and second ends, said dual-tipped member being disposed within the catheter, on one side of said cross-member where said tissue-receiving area is defined, such that said dual-tipped member is axially moveable back and forth through said tissue-receiving area.

8. The device of claim 7 further comprising:

an advancing/retracting member for driving said tissue-penetrating member back and forth, said advancing/retracting member having a generally C-shaped distal portion which partially surrounds said cross-member within the catheter, said generally C-shaped distal portion having a first end which is abatable against the first end of the dual-tipped needle, and a second end which is abatable against the second end of the dual-tipped needle;

said advancing/retracting member being moveable back and forth within said catheter to drive said dual-tipped needle back and forth between;

i) a first position wherein said dual-tipped member is positioned proximal to the tissue-receiving area; and

,

ii) a second position wherein said dual-tipped member is positioned distal to the tissue-receiving area.

9. The device of claim 7 wherein a hollow depression is formed in said cross-member in alignment with said side opening, said hollow depression defining a portion of said tissue-receiving area such that tissue which intrudes inwardly through said side opening may extend into said depression.

10. The device of claim 5 wherein the tissue-penetrating member is a single-tipped member having a sharpened distal end, and wherein said device further comprises:

an elongate advancing/retracting member disposed within said catheter and axially moveable to drive said tissue-penetrating member back and forth, said advancing/retracting member being alternately connectable to, and disconnectable from, said tissue-penetrating member.

11. The device of claim 10 wherein said advancing/ retracting member has a sharpened distal end which is capable of penetrating through tissue which intrudes into said tissue-receiving area.

12. The device of claim 8 wherein said advancing/retracting member is penetrate through tissue which intrudes into the tissue-receiving area while said tissue penetrating member is positioned in its second position, and to thereafter become connected to said tissue-penetrating member and to pull said tissue-penetrating member from its second position, through the intruding tissue, to its first position, with said connector material in tow.

13. The device of claim 8 wherein the advancing/retracting member is attachable to the tissue-penetrating member by i.) positioning the distal end of the advancing/retracting member in juxtaposition to the tissue-penetrating member and ii.) subsequently rotationally moving advancing-retracting member in a first rotational direction, while maintaining said tissue-penetrating member in a non-rotating fixed position;

and wherein said device further comprises;

least one needle-rotation-preventing member formed within the catheter lumen to maintain said tissue-penetrating member in said non-rotating, fixed position.

14. An outboard-penetrating-member embodiment of the device of claim 1 wherein the device further comprises:

a main lumen which extends longitudinally through at least a portion of the catheter;

a first opening formed in the catheter at a first location;

a second opening is formed in the catheter at a second location, said second location being a spaced distance from said first location;

a first branch lumen formed within the catheter and extending from the main lumen to the first opening;

a second branch lumen formed within the catheter and extending from the second opening to the main lumen; and

, wherein,

said tissue-penetrating member is initially positioned within the main lumen at a first position, proximal to said first opening, and is therafter advanceable i.) out of said first opening, ii.) through a portion of the wall of the anatomical structure, iii.) into the second opening, and iv.) to a second position within the catheter, said second position being distal to said second opening.

15. The device of claim 14 wherein:

said main lumen is formed longitudinally within a distal portion of the catheter from a location proximal to the fircation of said main lumen and said first branch lumen; and

, wherein,

said tissue penetrating member is a resilient member which is biased to a curved configuration, said tissue-penetrating member being advancable from said first position, through said first branch lumen, outwardly through said first opening, at least partially through the adjacent wall of the anatomical structure, inwardly through said second opening, and through said second branch lumen to its second position, the curved configuration of said tissue-penetrating member being operative to guide the tissue-penetrating member to reenter the catheter through said second opening after it has been advanced out of said first opening.

16. The device of claim 14 wherein said tissue-penetrating member is retractable from its second position, through the main lumen of the the catheter, back to its first position.

17. The device of claim 14 wherein said tissue-penetrating member is caused to advance and retract by way of an advancing/retraction member which extends through the catheter and which is alternately connectable to, and disconnectable from, said tissue-penetrating member.

18. The device of claim 17 wherein said main lumen comprises:

i.) an upper lumen portion wherein said tissue-penetrating member is disposed;

ii.) a lower lumen portion which is parallel to said upper lumen portion and which extends through to the proximal end of the catheter; and

,

iii.) an elongate, hollow connector channel which forms a side-to-side connection between said upper lumen portion and said lower lumen portion;

and wherein said advancing/retraction member comprises;

i.) an elongate shaft which is slidably disposed within said lower lumen portion;

ii.) a clamp which is connected to said shaft and which extends laterally from said shaft, through said connector channel, and into said upper lumen portion, said clamp being useable to alternately grasp and release said tissue-penetrating member to facilitate the advancement and retraction of said tissue-penetrating member by said advincing/retraction member.