Releasable tissue anchoring device, methods for using, and methods for making

• US 8,454,652 B1
• Filed: 12/31/2009
• Issued: 06/04/2013
• Est. Priority Date: 10/29/2002
• Status: Expired due to Term

• Current Assignee: Microfabrica Incorporated (Technoprobe S.P.A.)
• Original Assignee: Microfabrica Incorporated (Technoprobe S.P.A.)
• Inventors: Cohen, Adam L., Folk, Christopher R.
• Primary Examiner(s): Woo, Julian
• Assistant Examiner(s): Templeton, Christopher L
• Application Number:
  US12/651,388
• Time in Patent Office: 1,251 Days
• Field of Search: 606/213, 606215-218, 606/157, 606/67, 606/68, 606/151, 411340-342
• US Class Current: 606/218
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• 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 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00345 Micromachines, nanomachines, microsystems
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/061 hollow or tubular
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/088 Sliding fasteners
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing

Abstract

Embodiments of invention are directed to tissue approximation instruments that may be delivered to the body of a patient during minimally invasive or other surgical procedures. In one group of embodiments, the instruments have an elongated configuration with two sets of expandable wings that each have spreadable wings that can be made to expand when located on opposite sides of a distal tissue region and a proximal tissue region and can then be made to move toward one another to bring the two tissue regions into a more proximate position. The instrument is delivered through a needle or catheter and is controlled by relative movement of a push tube and control wire wherein the control wire can be released from the instrument via rotation in a first direction and can cause release of the approximation device from tissue that it is holding by rotation in the opposite direction.

Claims

1. A surgical procedure for approximating tissue within a patient'"'"'s body, comprising:

(a) locating an approximation instrument within a body of a patient at an end of a catheter wherein the approximation instrument is functionally engaged with a control wire and a push tube;

the instrument comprising;

(i) a first set of expandable elements;

(ii) a second set of expandable elements;

(iii) a rail along which the first and second sets of expandable elements are located; and

(iv) a locking mechanism for allowing the first and second sets of expandable elements to be relatively moved to more proximate positions while inhibiting movement of the first and second sets of expandable elements to a more distant relative position along a length of the rail, after being moved to the more proximate position;

(v) a threaded engagement feature for engaging the control wire;

(vi) a seat region for engaging the push tube wherein the wire and the push tube engage relatively movable elements and that upon relative motion can be made to bring the first and second set of expandable elements to their more proximate position;

(vii) a controllable stop element that inhibits the first set of expandable elements from extending beyond a desired retention position when located in a first position and allows distal axial collapse of the first set of expandable elements when located in another position so that the instrument may be extracted in its entirety from a proximal side of the tissue;

(b) inserting a distal end of the instrument through a proximal tissue region and then through a separated distal tissue region;

(c) expanding the first set of expandable elements;

(d) locating the first set of expanded elements against a wall of the distal tissue region;

(e) expanding the second set of expandable elements;

(f) locating the second set of expanded elements against a wall of the proximal tissue region;

(g) relatively moving the first set of expanded elements and the second set of expanded elements toward one another to bring the proximal and distal tissue regions into a more proximate position; and

(h) releasing at least a portion of the instrument from the catheter by rotating the control wire in a first direction so that a portion of the instrument that contains the first and second sets of expanded elements remains in the body of the patient and retains the distal and proximal tissue regions in the more proximate position,

wherein the instrument is disengaged from the distal and proximal tissue regions by rotating the control wire in an opposite direction to that of the first direction to allow collapse of the first set of expandable elements in a distal direction as the instrument is extracted in a proximal direction.

2. A surgical procedure for approximating tissue within a patient'"'"'s body, comprising:

(a) locating an approximation instrument within a body of a patient at an end of a catheter wherein the approximation instrument is functionally engaged with a control wire and a push tube;

the instrument comprising;

(i) a first set of expandable elements;

(ii) a second set of expandable elements;

(iii) a rail along which the first and second sets of expandable elements are located; and

(iv) a locking mechanism for allowing the first and second sets of expandable elements to be relatively moved to more proximate positions while inhibiting movement of the first and second sets of expandable elements to a more distant relative position along a length of the rail, after being moved to the more proximate position;

(v) a threaded engagement feature for engaging the control wire;

(vi) a seat region for engaging the push tube wherein the wire and the push tube engage relatively movable elements and that upon relative motion can be made to bring the first and second set of expandable elements to their more proximate position;

(vii) a controllable stop element that inhibits the first set of expandable elements from extending beyond a desired retention position when located in a first position and allows distal axial collapse of the first set of expandable elements when located in another position so that the instrument may be extracted in its entirety from a proximal side of the tissue;

(b) inserting a distal end of the instrument through a proximal tissue region and then through a separated distal tissue region;

(c) expanding the first set of expandable elements;

(d) locating the first set of expanded elements against a wall of the distal tissue region;

(e) expanding the second set of expandable elements;

(f) locating the second set of expanded elements against a wall of the proximal tissue region;

(g) relatively moving the first set of expanded elements and the second set of expanded elements toward one another to bring the proximal and distal tissue regions into a more proximate position; and

(h) releasing at least a portion of the instrument from the catheter by rotating the control wire in a first direction so that a portion of the instrument that contains the first and second sets of expanded elements remains in the body of the patient and retains the distal and proximal tissue regions in the more proximate position

wherein the control wire is rotatable relative to the engagement feature such that upon rotation in one direction the control wire is disengaged while rotation in an opposite direction causes turning of an oppositely threaded screw which causes movement of the stop to a second position.