Tool, a sealing device, a system and a method for closing a wound

• US 6,860,895 B1
• Filed: 06/18/1999
• Issued: 03/01/2005
• Est. Priority Date: 06/18/1999
• Status: Expired due to Term

• Current Assignee: St. Jude Medical Coordination Center BVBA (Abbott Laboratories Incorporated)
• Original Assignee: Radi Medical Systems AB (Abbott Laboratories Incorporated)
• Inventors: Preinitz, Fredrik, Egnelov, Per, Akerfeldt, Dan
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US10/018,137
• Time in Patent Office: 2,083 Days
• Field of Search: 606/116, 606/117, 606/139, 606/142, 606/151, 606/213, 606215-217, 292/314
• US Class Current: 606/215
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening

Abstract

A tool (101) is provided for inserting and mating two plug members (2, 3) of a sealing device (1) for closing a wound in the wall of a vessel by placing the distal plug member (2) of the sealing device inside the vessel and the proximal plug member (3) on the outside of the vessel. The distal plug member is provided with an elongated retracting means (6) extending from the distal plug member. The tool comprises a gear mechanism (32) coupled to the retracting means for converting a movement of the tool in a proximal direction away from the wound (22), when the distal plug member is anchored in the vessel (20), to a pushing movement for moving the proximal plug member in a direction towards the distal plug member in response to a stretching force in the retracting means.

Claims

1. A tool (101;

102) for inserting and mating two bioabsorbable plug members (2, 3) of a sealing device (1) for closing a wound in the wall of a blood vessel, one bioabsorbable plug member of the sealing device being a bioabsorbable distal plug member (2) to be positioned inside the blood vessel and the other bioabsorbable plug member being a bioabsorbable proximal plug member (3) to be positioned outside of the blood vessel, the bioabsorbable distal plug member being provided with an elongated retracting means (6) extending from the bioabsorbable distal plug member, wherein

the tool comprises a gear mechanism (32;

132) coupled to the retracting means for converting a movement of the tool in a proximal direction away from the wound, when the bioabsorbable distal plug member is anchored in the blood vessel, to a pushing movement for moving the bioabsorbable proximal plug member in a direction towards the bioabsorbable distal plug member, the pushing movement being induced by a stretching force (F₁) in the retracting means.

2. The tool (101;

102) according to claim 1, wherein the tool comprises a spring-biased coupling means (41;

164, 166) for releasably coupling the retracting means (6) to said gear mechanism (32;

132).

3. The tool (101;

102) according to claim 2, wherein the biasing force of said spring-biased coupling means (41;

164, 166) is selected to release the retracting means (6) when the stretching force (F₁) in the retracting means exceeds a selected force attributed to the rupture-tension of the wall of the blood vessel.

4. The tool (101;

102) according to claim 1, wherein said tool comprises;

an outer feeding means (33;

133) for pushing the bioabsorbable proximal plug member (3), said outer feeding means being provided with an axial through bore;

an inner feeding means (34;

134) for pushing the bioabsorbable distal plug member (2), said inner feeding means being provided with an axial through bore for moveably receiving said retracting means (6), said inner feeding means being disposed for movement in said bore of said outer feeding means, said gear mechanism (32;

132) being coupled to said inner feeding means and said outer feeding means; and

a pushing means (36;

150) for pushing the gear mechanism (32;

132), the outer feeding means (33;

133), and the bioabsorbable proximal plug member (3), with respect to a casing (30;

130) of the tool, in a direction towards the wound.

5. The tool (102) according to claim 4 wherein said gear mechanism (132) comprises at least one of a set, the set comprising:

a gear rack (170a, 170b) fixed to said pushing means (150);

a cog rail (163a, 163b) connected to said outer feeding means (133);

a double gear wheel (168a, 168b) having a small gear ring (180) and a large gear ring (181) fixed with respect to each other, said double gear wheel being rotatably connected to a plate member (164), said large gear ring (181) being in engagement with said gear rack (170a, 170b), and said small gear ring (180) being in engagement with said cog rail (163a, 163b);

wherein

said plate member (164) is arranged to move with said outer feeding means and said plate member releasably holds the retracting means by means of a spring (166), the retracting means being moveably disposed in the bore of said inner feeding means, and wherein

said set is thereby cooperatively arranged to convert a proximal movement of said tool to a distal movement of said outer feeding means when the retracting means is stretched.

6. The tool (101) according to claim 4 wherein said gear mechanism (32) comprises:

a first pulley (38) attached to said outer feeding means via a spacer member (37);

a second pulley (40) attached to said inner feeding means (34);

a first brake means (41) attached to said inner feeding means;

a second brake means (43) attached to said pushing means (36);

wherein

the retracting means (6) is arranged such that it extends from the bioabsorbable distal plug member (2) in a proximal direction, through said bore of said inner feeding means (33), through the first brake means (41), around said first pulley (38) to be redirected to a distal direction, around said second pulley (38) to be redirected again to the proximal direction, and through said second brake means (43).

7. A method for closing a wound in a punctured blood vessel with a tool, comprising:

inserting and mating two plug members (2, 3) of a sealing device (1), one plug member of the sealing device being a distal plug member (2) to be positioned inside the blood vessel and the other plug member being a proximal plug member (3) to be positioned outside of the blood vessel, the distal plug member being provided with an elongated retracting means (6) extending from the distal plug member;

positioning the distal plug member (2) inside the blood vessel with the retracting means (6) being attachable to the tool comprising a gear mechanism (32;

132) connectable to the retracting means for converting a movement of the tool in a proximal direction away from the wound, to a pushing movement for moving the proximal plug member in a direction towards the distal plug member in response to a stretching force (F₁) in the retracting means when the distal plug member is anchored in the blood vessel; and

withdrawing the tool (101;

102) with the retracting means attached thereto to stretch the retracting means, thereby activating the gear mechanism to approach the proximal plug member towards the distal plug member via a feeding means (34;

134).

8. The method according to claim 7, wherein said tool (101;

102) comprises a spring-biased coupling means (41;

164, 166) for releasably coupling the retracting means (6) to said gear mechanism (32;

132).

9. A system for closing a wound in a punctured blood vessel, comprising:

obtaining a sealing device comprising;

a distal resiliently expandable plug member (2) having an elongated retracting means extending centrally from a distal plug member and including a portion (10) for attaching a proximal plug member (3) of the sealing device, the proximal plug member being resiliently expandable and being adapted to be mounted onto the distal plug member to be fixed thereto by means of the attaching portion, wherein

the proximal plug member comprises a through bore (9), the distal plug member comprises a through bore (8), and a suture (6) is passed through said bore (8) to serve as the retracting means by providing an enlarged portion at one end as a counter when pulling the suture; and

inserting and mating the sealing device using a tool, the tool comprising;

a gear mechanism coupled to the retracting means for converting a movement of the tool in a proximal direction away from the wound, when the distal plug member is anchored in a blood vessel, to a pushing movement for moving the proximal plug member in a direction toward the distal plug member, the pushing movement being induced by a stretching force in the retracting means.

10. A tool (101;

102) for closing a wound by positioning a bioabsorbable distal plug inside a blood vessel and a bioabsorbable proximal plug positioned outside of the blood vessel, comprising;

a casing; and

a movement direction reverser (32;

132) adapted to be coupled to a retractor which is coupled to the bioabsorbable distal plug, wherein the movement direction reverser, when coupled to the retractor, is adapted to convert movement of the casing in a proximal direction away from the wound when the bioabsorbable distal plug is anchored in the blood vessel to a pushing movement to move the bioabsorbable proximal plug in a direction towards the bioabsorbable distal plug, the pushing movement to move the bioabsorbable proximal plug being induced by a tension force imparted on the retractor.

11. The tool (101;

102) according to claim 10, wherein the tool comprises a spring-biased coupling (41;

164, 166) adapted to releasably couple the retractor (6) to the movement direction reverser (32;

132).

12. The tool (101;

102) according to claim 11, wherein the biasing force of said spring-biased coupling (41;

164, 166) is sufficient to release the retractor (6) when the force imparted on the retractor exceeds a selected force based on the rupture-tension of a wall of the blood vessel.

13. The tool (101;

102) according to claim 10, wherein said tool comprises;

an outer feed boom (33;

133) adapted to push the bioabsorbable proximal plug (3), said outer feed boom being provided with an axial through bore;

an inner feed boom (34;

134) adapted to push the bioabsorbable distal plug (2), said inner feed boom being provided with an axial through bore adapted to moveably receive said retractor (6), said inner feed boom being further adapted to move in said bore of said outer feed boom, said movement direction reverser (32;

132) being coupled to said inner feed boom and said outer feed boom; and

a pusher (36;

150) adapted to push the movement direction reverser (32;

132), the outer feed boom (33;

133), and the bioabsorbable proximal plug (3), with respect to the casing (30;

130) of the tool, in a direction towards the wound.

14. The tool (102) according to claim 13 wherein said movement direction reverser (132) comprises at least one of a set of components, the set of components comprising:

a gear rack (170a, 170b) fixedly connected to said pusher (150);

a cog rail (163a, 163b) fixedly connected to said outer feed boom (133);

a double gear wheel (168a, 168b) having a small gear ring (180) and a large gear ring (181) fixed with respect to each other, said double gear wheel being rotatably connected to a plate (164), said large gear ring (181) being in engagement with said gear rack (170a, 170b), and said small gear ring (180) being in engagement with said cog rail (163a, 163b);

wherein

said plate (164) is arranged to move with said outer feed boom, and said plate is adapted to releasably hold the retractor with a device including a spring (166), the retractor being moveably disposed in the bore of said inner feed boom, and wherein

said set is cooperatively arranged and adapted to convert a proximal movement of said casing to a distal movement of said outer feed boom in conjunction with a tension force on the retractor.

15. The tool (101) according to claim 13 wherein said movement direction reverser (32) comprises:

a first pulley (38) attached to said outer feed boom via a spacer (37);

a second pulley (40) attached to said inner feed boom (34);

a first brake (41) attached to said inner feed boom;

a second brake (43) attached to said pusher (36);

wherein

the retractor (6) is arranged such that when the retractor is coupled to the movement direction reverser, the retractor extends from the bioabsorbable distal plug (2) in a proximal direction, through said bore of said inner feed boom (33), through the first brake (41), around said first pulley (38) to be redirected in a distal direction, around said second pulley (38) to be redirected to the proximal direction, and through said second brake (43).

16. The tool (101;

102) according to claim 10, further comprising the retractor.

17. A method for closing a wound in a punctured blood vessel utilizing two plugs (2, 3) of a sealing device (1), comprising:

inserting a distal plug (2) through a wound and positioning the distal plug inside the blood vessel and positioning a proximal plug (3) outside the blood vessel, the distal plug being provided with a retractor (6) extending from the distal plug;

pushing the proximal plug towards the distal plug with a tool comprising a casing and a movement direction reverser (32;

132) coupled to the retractor by converting a movement of the casing in a proximal direction away from the wound to a pushing movement to move the proximal plug in a direction towards the distal plug, the pushing movement to move the proximal plug being induced by a tension force on the retractor.

18. The method of claim 17, wherein movement of the casing in the proximal direction results from withdrawing the tool (101;

102) with the retractor attached to the tool, wherein the tension force on the retractor results from withdrawing the tool (101;

102) with the retractor attached to the tool and the distal plug (2) anchored in the blood vessel, and wherein the tension force on the retractor induces the movement direction reverser to drive the proximal plug towards the distal plug.

19. The method according to claim 17, wherein said tool (101;

102) comprises a spring-biased coupling (41;

164, 166) adapted to releasably couple the retractor (6) to said movement direction reverser (32;

132).

20. A sealing device (1) comprising:

a distal resiliently expandable plug (2) having an elongated retractor extending centrally from the distal resiliently expandable plug and including an attaching portion (10) adapted to attach to a proximal plug (3) of the sealing device, the proximal plug being resiliently expandable and being adapted to be mounted onto the distal plug and to be fixed thereto by the attaching portion, wherein

the distal plug comprises a through bore (8), and a suture (6), the suture extending through said bore (8) and forming at least a portion of the retractor, the suture having an enlarged portion at one end that is adapted to provide a counter surface when a tension force is imparted on the suture, wherein

the sealing device is inserted and mated by the use of a tool, wherein the tool comprises a movement direction reverser coupled to the retractor and adapted to convert movement of at least a portion of the tool in a proximal direction away from the wound, when the distal plug is anchored in a blood vessel, to a pushing movement for moving the proximal plug in a direction toward the distal plug, the pushing movement to move the proximal plug being induced by a tension force in the retractor.

21. The sealing device according to claim 20, wherein the distal plug is bioabsorbable.

22. The sealing device according to claim 20, wherein the proximal plug is bioabsorbable.