SYSTEM FOR CLOSING A PUNCTURE IN A VESSEL WALL

• US 20080319458A1
• Filed: 12/19/2007
• Published: 12/25/2008
• Est. Priority Date: 06/25/2007
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Reynolds, Timothy C.
• Granted Patent: US 8,574,244 B2
• Time in Patent Office: Days
• 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 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 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• 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 hollow suture needles A61B2017/061

Abstract

A device is provided herein for deploying a suture in a puncture through a vessel wall of a blood vessel, the puncture disposed within a tissue tract of a patient body. The device includes a shaft suitable for insertion along the tissue tract and into the vessel through a puncture, a plurality of needles, each needle having a proximal end and a distal end suitable for forming a needle path through the vessel wall, wires associated with each needle, each wire having a distal end and a proximal end, and hooks coupled to each of the distal ends of each wire, each hook being configured to anchor the wire to an interior portion of the vessel wall.

Claims

1. A device for deploying a suture in a puncture through a vessel wall of a blood vessel, the puncture disposed within a tissue tract of a patient body, the device comprising:

a shaft suitable for insertion along the tissue tract and into the vessel through a puncture;

a plurality of needles, each needle having a proximal end and a distal end suitable for forming a needle path through the vessel wall;

wires associated with each needle, each wire having a distal end and a proximal end; and

hooks coupled to each of distal ends of each wire, each hook being configured to anchor the wire to an interior portion of the vessel wall.

2. The device of claim 1, wherein at least one hook is configured to be stored completely within one of the needles prior to deployment and to be extended beyond the distal end of the needle after deployment.

3. The device of claim 1, wherein the hooks comprise hooks formed from the distal end of the suture.

4. The device of claim 1, further comprising a foot coupled to the shaft, the foot being configured to move from a low profile configuration aligned along the shaft to a deployed configuration extending laterally from the shaft and along the vessel and wherein the first and second needles are advanced from a stored positioned within the shaft through the vessel wall outside the puncture.

5. The device of claim 4, wherein the foot includes guide channels defined therein for guiding the needles as the needles advance in cantilever and distally relative to the shaft.

6. The device of claim 1, further comprising a proximal body and a needle deployment handle coupled to the proximal end of the needles, wherein moving the needle deployment handle toward the proximal body deploys the needles.

7. The device of claim 6, further comprising a hook deployment handle, wherein moving the hook deployment handle distally relative to the needle deployment handle deploys the hooks.

8. The device of claim 7, further comprising a pull pin configured to retain the hook deployment handle in position relative to the needle deployment handle as the needle deployment handle is moved toward the proximal body to deploy the needles and is configured to be removed to allow the hook deployment handle to move distally relative to the needle deployment handle to deploy the hooks.

9. The device of claim 7, wherein the hook deployment handle has a push mandrel coupled thereto, the push mandrel being configured to deploy the hooks when the hook deployment handle is moved distally relative to the needle deployment handle.

10. The device of claim 1, wherein at least one of the hooks comprises a single tip configured to move away from at least one of the wires.

11. The device of claim 1, wherein at least one of the hooks comprises a plurality of tips configured to form a T-shape when deployed.

12. A device for closing a suture in a puncture through a vessel wall of a blood vessel, the puncture disposed within a tissue tract of a patient body, the device comprising:

a body configured to have a plurality of suture wires coupled thereto;

a pair of guide lumens extending distally from the guide body; and

a guide tip configured to provide a gap between the distal end of the lumens and the vessel wall, such that when the body and guide lumens are rotated a twist is initiated in the wires at a desired location away from the vessel wall.

13. The device of claim 12, further comprising a constant force mechanism coupled to the body, the constant force mechanism being configured to provide constant tension to the suture wires during a twisting operation.

14. The device of claim 13, the constant force mechanism further comprising constant force springs and a wire securing mechanism for removably securing the sutures to the constant force mechanism.

15. The device of claim 13, further comprising a retaining block configured to place the constant force mechanism in a biased position.

16. The device of claim 13, further comprising a loading device, the loading device comprising a body having funneled opening defined on a distal end and a tip receiving recess on defined in a proximal end for receiving the guide tip.

17. The device of claim 16, wherein the loading device has a clamshell configuration.

18. A method for suturing a puncture through a vessel wall of a blood vessel, the puncture disposed within a tissue tract of a patient body, the method comprising:

advancing a plurality of needles through the vessel wall outside the puncture;

advancing hooks from a plurality of distal ends of the plurality of needles, wherein the plurality of hooks are coupled to wires and at least a portion of the wires remain outside the vessel wall;

anchoring the hooks to interior portions of the vessel wall; and

twisting the wires to close the puncture.

19. The method of claim 18, wherein advancing the plurality of needles through the vessel wall includes actuating a needle deployment handle on a deployment device and advancing the hooks includes actuating a hook deployment handle on the device.

20. The method of claim 19, further comprising a preliminary step of advancing the deployment device to a desired position relative to the vessel by advancing the deployment device over a guidewire, the guidewire extending through the puncture into the vessel.

21. The method of claim 19, further comprising removing the deployment device after anchoring the hooks to the interior portions of the vessel wall and coupling the wires to a closure device, the closure device being used in twisting the wires to close the puncture.

22. The method of claim 21, wherein coupling the wires to a closure device includes advancing the wires through a loading device, the loading device having funneled openings defined therein to receive the wires and a recess defined therein to receive a portion of the closure device.

23. The method of claim 18, further comprising inserting a distal end of a shaft through the puncture, said shaft having a foot, articulating the elongate foot of the shaft within the blood vessel so that the foot moves from a low profile configuration aligned along a shaft to a deployed configuration extending laterally from the shaft and along the vessel and wherein the first and second needles are advanced from a stored positioned within the shaft through the vessel wall outside the puncture.

24. A system for closing a puncture through a vessel wall of a blood vessel, the puncture disposed within a tissue tract of a patient body, the method comprising:

a deployment device including a shaft suitable for insertion along the tissue tract and into the vessel through a puncture, a plurality of needles, each needle having a proximal end and a distal end suitable for forming a needle path through the vessel wall, wires associated with each needle, each wire having a distal end and a proximal end, and hooks coupled to each of the distal ends of each wire, each hook being configured to anchor the wire to an interior portion of the vessel wall; and

a closure device, the closure device being configured to twist the wires to close the puncture.

25. The system of claim 24, wherein the closure device includes a constant force mechanism configured to provide an independent biasing force on each wire during a twisting operation.