Apparatus and method for approximating and closing the walls of a hole or puncture in a physiological shell structure

• US 6,383,208 B1
• Filed: 11/03/2000
• Issued: 05/07/2002
• Est. Priority Date: 11/05/1999
• Status: Expired due to Term

• Current Assignee: DVL Acquisition Sub, Inc. (Becton, Dickinson & Co)
• Original Assignee: ONUX Medical, Inc. (Becton, Dickinson & Co)
• Inventors: Sancoff, Gregory E., Field, Frederic P.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/706,471
• Time in Patent Office: 550 Days
• Field of Search: 606/213, 606/139, 606/144, 606/148
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end

Abstract

Apparatus for approximating and closing the walls of a hole or puncture in a physiological shell structure which, in one preferred form, comprises a pair of components that manipulate wire suture. The first component, sometimes referred to herein as a suture introducer, locates the edges of the hole and passes wire suture through them. The second component, sometimes referred to herein as a suture tensioner, gathers the free ends of the wire suture and twists them together, which in turn closes the hole. After the wire suture has been twisted sufficiently to effect closure, the excess wire is trimmed away. The apparatus can deploy more than one wire suture at a time if desired. Using self-locating features and tactile feedback, the apparatus is particularly well adapted to access remote surgical sites.

Claims

1. A suture introducer comprising:

an elongated housing having a proximal end and a distal end, a first channel extending distally through said housing, and second and third channels communicating with said first channel and opening on the exterior of said housing;

said first channel being sized to receive the midsection of a loop of suture, and said second and third channels each being sized to receive a free end of the same loop of suture, and said second and third channels being configured so that when the midsection of a loop of suture is positioned in said first channel and one free end of the same loop of suture is positioned in each of the second and third channels, and said housing is positioned in tissue, pushing distally on the midsection of the loop of suture will cause the two free ends of the same loop of suture to exit the second and third channels so as to penetrate the tissue;

said elongated housing being hinged so as to selectively release the midsection of the loop of suture.

2. A suture introducer according to claim 1 wherein said second and third channels are configured so that the two frees ends of suture will be directed proximally after they exit said second and third channels.

3. A suture introducer according to claim 1 wherein suture introducer further comprises first and second suture gripping and transporting mechanisms, wherein said first and second suture gripping and transporting mechanisms are each adapted to (i) grip one free end of the loop of suture after that free end exits said housing and passes through the tissue, and (ii) transport that free end of the loop of suture proximally.

4. A suture tensioner comprising:

a support tube having a proximal end and a distal end, said support tube having a first larger diameter at its proximal end, a second smaller diameter at its distal end, and a transition section therebetween; and

a twisting shaft having a proximal end and a distal end, said twisting shaft comprising a pair of elements pivotally connected together at their proximal ends;

said twisting shaft being configured so that (i) when said distal end of said twisting shaft is positioned in said first larger diameter region of said support tube, said twisting shaft can slidably receive a pair of suture ends, (ii) when said distal end of said twisting shaft is thereafter positioned in said transition section of said support tube, said twisting shaft can grip that pair of suture ends, and (iii) when said distal end of said twisting shaft is thereafter positioned in said second smaller diameter region of said support tube, said twisting shaft can sever that pair of suture ends.

5. A suture tensioner according to claim 4 wherein said support tube is formed with a crown configuration on its distal end.

6. A suturing system comprising:

a suture introducer comprising;

an elongated housing having a proximal end and a distal end, a first channel extending distally through said housing, and second and third channels communicating with said first channel and opening on the exterior of said housing;

said first channel being sized to receive the midsection of a loop of suture, and said second and third channels each being sized to receive a free end of the same loop of suture, and said second and third channels being configured so that when the midsection of a loop of suture is positioned in said first channel and one free end of the same loop of suture is positioned in each of the second and third channels, and said housing is positioned in tissue, pushing distally on the midsection of the loop of suture will cause the two free ends of the same loop of suture to exit the second and third channels so as to penetrate the tissue;

said elongated housing being hinged so as to selectively release the midsection of the loop of suture; and

a suture tensioner comprising;

a support tube having a proximal end and a distal end, said support tube having a first larger diameter at its proximal end, a second smaller diameter at its distal end, and a transition section therebetween; and

a twisting shaft having a proximal end and a distal end, said twisting shaft comprising a pair of elements pivotally connected together at their proximal ends;

said twisting shaft being configured so that (i) when said distal end of said twisting shaft is positioned in said first larger diameter region of said support tube, said twisting shaft can slidably receive a pair of suture ends, (ii) when said distal end of said twisting shaft is thereafter positioned in said transition section of said support tube, said twisting shaft can grip that pair of suture ends, and (iii) when said distal end of said twisting shaft is thereafter positioned in said second smaller diameter region of said support tube, said twisting shaft can sever that pair of suture ends.

7. A method for closing an opening in tissue with a length of suture, comprising:

placing the length of suture in a substantially U-shaped configuration;

passing the two free ends of the suture distally through the opening, so that the two free ends lie on the distal side of the opening and the bridge of the suture lies on the proximal side of the opening;

driving the bridge of the suture distally so that (i) the two free ends of the suture pass through the tissue so that they lie on the proximal side of the opening, and (ii) the bridge of the suture passes through the opening and lies on the distal side of the opening;

pulling the two free ends of the suture proximally so as to close the opening in the suture; and

making the two free ends of the suture fast so as to hold the tissue closed.