Device and method for suturing blood vessels and the like

• US 6,139,556 A
• Filed: 10/29/1997
• Issued: 10/31/2000
• Est. Priority Date: 10/29/1997
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Original Assignee: X-Site LLC
• Inventors: Kontos, Stavros
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): GOLDBERG, JONATHAN D
• Application Number:
  US08/960,486
• Time in Patent Office: 1,098 Days
• Field of Search: 606/139, 606/144, 606/145, 606/148, 112/169, 112/80.03
• US Class Current: 606/144
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen

Abstract

A method and device for sealing an opening in an anatomical structure within a living body involves the positioning of the tissue adjacent to the opening within a gap between proximal and distal parts of a tube formed by a curved central part. A needle coupled to a suture is pushed from a needle retention channel formed within the proximal part through the tissue received in the gap and into a needle receiving channel formed within the distal part. The device may be moved to a second position where a new region of tissue is located in the gap between the proximal and distal parts of the tube. The needle may be pushed or drawn out of the receiving channel in the distal part, through the tissue and into the receiving channel in the proximal part to thereby loop the suture through the anatomical structure. The procedure may be repeated to form multiple suture loops in the structure and then the ends of the suture may be knotted. Needle pushing mechanisms may be adapted to move through the needle retention channels, and thus may be used to push a needle through the device. The device may include a trigger mechanism which is adapted to move the needle pushing mechanisms and thus the needle may be placed through the anatomical structure through operation of the trigger mechanism.

Claims

1. A device for sealing an opening in an anatomical structure within a living body such as a blood vessel, the device comprising:

a tube including proximal and distal parts coupled together by a central part which extends away from the proximal part to form a gap between a distal end of the proximal part and a proximal end of the distal part, wherein the proximal part includes an end portion which, when the device is in an operative position, is located outside the body;

a distal needle lumen extending within the distal part to a distal part opening formed in the proximal end of the distal part;

a proximal needle lumen extending within the proximal part to a proximal part opening formed in the distal end of the proximal part so that the proximal part opening faces the distal part opening across the gap;

a proximal needle pusher slidably received within the proximal needle lumen for pushing a needle coupled to a length of suture distally through the proximal needle lumen, out of the proximal part opening and across the gap into the distal part opening so that, when the device is positioned with a first portion of the anatomical structure received within the gap, the needle pierces the first portion of the anatomical structure before entering the distal part opening; and

a distal needle pusher slidably mounted within the distal needle lumen for pushing a needle proximally out of the distal part opening, across the gap and into the proximal part opening so that, when the device is positioned with a second portion of the anatomical structure received within the gap, the needle pierces the second portion of the anatomical structure prior to entering the proximal part opening.

2. The device according to claim 1, further including a suture removal slot disposed substantially parallel to and adjacent to the proximal needle lumen.

3. The device according to claim 1, further comprising a proximal spring disposed between the tube and the proximal needle pusher, wherein the proximal needle pusher is biased to a neutral position in which a distal end of the proximal needle pusher is separated from the proximal part opening by a predetermined distance.

4. The device according to claim 1, wherein the proximal needle pusher has a central bore extending therethrough.

5. The device according to claim 1, wherein the tube is formed of a first plastic piece including the proximal and central portions, coupled to a second piece comprising the distal part.

6. The device according to claim 1 further comprising a cable extending from a first end coupled to the distal needle pusher to a second end accessible to the user.

7. The device according to claim 1, further comprising a distal spring coupled between the tube and the distal needle pusher, the distal spring biasing the distal needle pusher to a neutral position within the distal needle lumen.

8. The device according to claim 1, further comprising a flashback lumen disposed extending from an opening formed distally of a proximal end of the central part to an exit formed in the proximal part, wherein fluid may flow from the anatomical structure into the opening, through the flashback lumen to the exit.

9. The device according to claim 1, further including a guide wire lumen extending through at least a portion of the distal part.

10. The device according to claim 1, wherein the distal part is formed of a first material having an increased flexibility relative to a second material included in at least one of the central and proximal parts.

11. A device for sealing an opening in an anatomical structure within a living body comprising:

a tube including proximal and distal parts extending along an axis wherein the proximal and distal parts are coupled together by a central part which extends away from the axis to form a gap between a distal end of the proximal part and a proximal end of the distal part and wherein the proximal part includes an end portion which, when the device is in an operative position, is located outside the body;

a distal needle lumen formed within the distal part wherein the distal needle lumen extends along the axis to a distal part opening formed in the proximal end of the distal part;

a distal needle pusher movably disposed in the distal needle lumen;

a proximal needle lumen formed within the proximal part and extending along the axis to a proximal part opening formed in the distal end of the proximal part;

a proximal needle pusher slidably received within the proximal needle lumen;

a handle coupled to the proximal part, the handle including a trigger rotatably coupled thereto, wherein when the handle is in a first configuration, the trigger is operatively connected to the distal needle pusher so that actuation of the trigger moves the distal needle pusher within the distal needle lumen and, when the handle is in a second configuration, the trigger is operatively connected to the proximal needle pusher so that actuation of the trigger moves the proximal needle pusher within the proximal needle lumen.

12. The device according to claim 11 further comprising a push plate which, when the handle is in the second configuration, is coupled between the proximal needle pusher and the trigger, so that actuation of the trigger causes the push plate to push the proximal needle pusher distally.

13. The device according to claim 11 further comprising a pull plate which, when the handle is in the first configuration, is coupled between the distal needle pusher and the trigger, so that actuation of the trigger causes the pull plate to pull a cable attached thereto, wherein the cable extends from the pull plate to a pulley proximal to the pull plate and to the distal needle pusher so that the distal needle pusher is pulled proximally.

14. A method for sealing an opening in an anatomical structure within a living body comprising the steps of:

inserting into the body a tube including proximal and distal parts coupled together by a central part which extends away from the proximal part to form a gap between a distal end of the proximal part and a proximal end of the distal part so that a first portion of the anatomical structure adjacent to the opening is received within the gap;

passing a needle coupled to a length of suture through the proximal part and out of the tube to pierce the first portion of the anatomical structure and pass into the distal part;

re-positioning the tube so that a second portion of the anatomical structure adjacent to the opening is received within the gap;

withdrawing the needle from the distal part so that it pierces the second portion of the anatomical structure and passes into the proximal part; and

coupling the ends of the length of suture together to seal the opening.