Large bore location device and methods

• US 9,820,735 B2
• Filed: 11/13/2012
• Issued: 11/21/2017
• Est. Priority Date: 11/16/2011
• Status: Active Grant

• Current Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Inventors: Tegels, Zachary J.
• Primary Examiner(s): Templeton, Christopher L
• Assistant Examiner(s): Mannan, Mikail
• Application Number:
  US13/675,889
• Publication Number:
  US 20130123812A1
• Time in Patent Office: 1,834 Days
• Field of Search: 606139-151, 606232
• 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 2017/00663 the implement being a suture
• 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 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22045 fixed to the catheter; guiding tip
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure

Abstract

A vascular closure system includes a body portion, an anchor, at least one suture member, and a plurality of needles. The anchor assembly includes a hub and a wire assembly. The hub has at least one aperture defined in a sidewall thereof. The wire assembly includes an actuator member extending proximally through the body portion and hub, and at least one pre-formed wire having a free proximal end and a distal end that is connected to the actuator member. Withdrawing the actuator member extends the proximal end of the at least one pre-formed wire out of the at least one aperture to capture a portion of the vessel wall between the pre-formed wire and the body portion. The plurality of needles extend through the vessel wall adjacent to the vessel puncture and are configured to connect to the at least one suture member.

Claims

1. A vascular closure system, comprising:

a body portion;

an anchor assembly positionable through a vessel puncture in a vessel wall of a vessel, the body portion having a distally facing surface configured to abut tissue external to the vessel wall, the anchor assembly including a hub and a wire assembly, the hub having at least one aperture defined in a sidewall thereof, and the wire assembly including an actuator member extending proximally through the body portion and hub, and at least one pre-formed wire having a proximal end, and a distal end connected to the actuator member, wherein withdrawing the actuator member extends the proximal end of the at least one pre-formed wire from a first position within the hub to a second position out of the at least one aperture to capture a portion of the vessel wall between the at least one pre-formed wire and the body portion, the at least one pre-formed wire being J-shaped;

at least one suture member positioned distal of the body portion;

a plurality of needles extendable from an exterior of the vessel wall through the portion of the vessel wall adjacent to the vessel puncture and into an interior of the vessel wall, the plurality of needles being configured to connect to the at least one suture member by extending through an outer surface of the hub, wherein the plurality of needles connect to the at least one suture member distal of the at least one ore-formed wire;

wherein withdrawal of the plurality of needles through the portion of the vessel wall positions the at least one suture member through the portion of the vessel wall.

2. A vascular closure system according to claim 1, wherein the at least one pre-formed wire of the wire assembly includes first and second pre-formed wires arranged on opposite sides of the actuator member.

3. A vascular closure system according to claim 2, wherein the at least one aperture comprises a first aperture and a second aperture, the first aperture being formed in the hub, the second aperture being formed in the hub, wherein the first pre-formed wire extends through the first aperture and the second pre-formed wire extends through the second aperture, the first aperture being proximally spaced on the hub relative to the second aperture.

4. A vascular closure system according to claim 1, wherein the proximal end of the at least one pre-formed wire is pre-positioned in the at least one aperture.

5. A vascular closure system according to claim 1, wherein the at least one pre-formed wire includes a contact tip at the proximal end, the contact tip having a bulbous shape.

6. A vascular closure system according to claim 1, wherein the proximal end of the at least one pre-formed wire extends radially outward upon withdrawal of the actuator member.

7. A vascular closure system according to claim 1, wherein the at least one pre-formed wire is welded to the actuator member.

8. A vascular closure system according to claim 1, wherein the body portion includes a handle assembly at a proximal end thereof, and first and second actuators operable to actuate the actuator member and the plurality of needles, respectively.

9. A vascular closure device, comprising:

a body portion;

a hub positionable through a puncture in a vessel and having at least one aperture defined in a sidewall thereof;

a wire assembly including an actuator wire extending through the body portion and hub, the actuator wire comprising a groove, the groove extending along a length dimension of the actuator wire, and at least one anchor wire having a distal end connected to the actuator wire in the groove and a proximal end movable between a first position within the hub and a second position extending out of the at least one aperture to capture a portion of a wall of the vessel between the anchor wire and the body portion upon withdrawal of the actuator wire, the body portion having a distally facing surface configured to abut tissue external to the vessel wall;

first and second suture members configured to be positioned within the vessel;

first and second pairs of needles operable to advance from an exterior of the vessel through the portion of the vessel adjacent to the puncture and into an interior of the vessel wall, extend through an outer surface of the hub to connect to the first and second suture members, and be withdrawn through the portion of the vessel to position the first and second suture members through the portion of the vessel, wherein the first and second pairs of needles connect to the first and second suture members distal of the at least one anchor wire.

10. A vascular closure device according to claim 9, wherein the at least one anchor wire includes first and second anchor wires configured to extend through first and second apertures defined in the sidewall of the hub.

11. A vascular closure device according to claim 9, further comprising a blood location port positioned proximal of the at least one aperture.

12. A vascular closure device according to claim 9, wherein the at least one anchor wire has a J-shape when in a rest position.

13. A vascular closure device according to claim 9, wherein the distal end of the at least one anchor wire is welded within the groove.

14. A method of positioning sutures across a vascular opening in a vessel wall, comprising:

providing a vascular closure device having a body portion, an anchor assembly, at least one length of suture, and a plurality of needles, the anchor assembly including a hub, an actuator wire, and a pre-formed wire having a distal end connected to the actuator wire, the pre-formed wire being J-shaped;

inserting the anchor assembly and at least one length of suture through the vascular opening;

withdrawing the actuator wire to advance a proximal end of the pre-formed wire from a first position within the hub to a second position external to the hub through a sidewall of the hub;

capturing a portion of the vessel wall between the pre-formed wire and a distal end of the body portion, the body portion having a distally facing surface configured to abut tissue external to the vessel wall;

advancing the plurality of needles from an exterior of the vessel wall through the portion of the vessel wall adjacent to the vascular opening and into an interior of the vessel wall;

connecting the plurality of needles to the at least one length of suture at a position distal to the ore-formed wire by extending the plurality of needles through an outer surface of the hub;

withdrawing the plurality of needles to position the at least one length of suture through the vessel wall adjacent to the vascular opening;

advancing the actuator wire to move the pre-formed wire into the hub;

removing the anchor assembly through the vascular opening.

15. The method of claim 14, further comprising providing a plurality of pre-formed wires that each extend through a separate wire aperture in the sidewall of the hub.

16. The method of claim 14, wherein advancing the proximal end of the pre-formed wire positions a bend portion of the pre-formed wire in contact with the vessel wall.

17. The method of claim 14, wherein advancing the actuator wire to move the pre-formed wire into the hub includes retracting all but a proximal tip of the pre-formed wire into the hub.

18. The method of claim 14, further comprising maintaining a generally linear shape in the pre-formed wire prior to advancing the proximal end of the pre-formed wire through the sidewall of the hub, and providing a contoured shape in the pre-formed wire after advancing the proximal end through the sidewall of the hub.

19. A vascular closure system, comprising:

a body portion;

an anchor assembly positionable through a vessel puncture in a vessel wall of a vessel, the anchor assembly including a hub and a wire assembly, the hub having at least two apertures defined in a sidewall thereof, and the wire assembly including an actuator member extending proximally through the body portion and hub, a first pre-formed wire, and a second pre-formed wire, the first and second pre-formed wires each having a proximal end, and a distal end connected to the actuator member, wherein withdrawing the actuator member extends the proximal ends of the first and second pre-formed wires from a first position within the hub to a second position out of the at least two apertures to capture a portion of the vessel wall between the first and second pre-formed wires and the body portion;

at least one suture member positioned distal of the body portion;

a plurality of needles extendable from an exterior of the vessel wall through the portion of the vessel wall adjacent to the vessel puncture and into an interior of the vessel wall, the plurality of needles being configured to connect to the at least one suture member distal to the first and second pre-formed wires with the plurality of needles extending through an outer surface of the hub;

wherein withdrawal of the plurality of needles through the portion of the vessel wall positions the at least one suture member through the portion of the vessel wall, and wherein the first and second pre-formed wires are arranged on opposite sides of the actuator member.

20. A vascular closure system, comprising:

a body portion;

an anchor assembly positionable through a vessel puncture in a vessel wall of a vessel, the anchor assembly including a hub and a wire assembly, the hub having a first aperture and a second aperture, the first and second apertures being defined in a sidewall of the hub, and the wire assembly including an actuator member extending proximally through the body portion and hub, a first pre-formed wire and a second pre-formed wire, the first and second pre-formed wires each having a proximal end, and a distal end connected to the actuator member, wherein withdrawing the actuator member extends the proximal end of the first pre-formed wire from a first position within the hub to a second position out of the first aperture to capture the vessel wall between the first pre-formed wire and the body portion, wherein withdrawing the actuator member extends the proximal end of the second pre-formed wire out of the second aperture to capture the vessel wall between the second pre-formed wire and the body portion, the first and second pre-formed wires each being J-shaped;

at least one suture member positioned distal of the body portion;

a plurality of needles extendable from an exterior of the vessel wall through the portion of the vessel wall adjacent to the vessel puncture and into an interior of the vessel wall, the plurality of needles being configured to connect to the at least one suture member distal to the first and second pre-formed wires;

wherein withdrawal of the plurality of needles through the portion of the vessel wall positions the at least one suture member through the portion of the vessel wall, wherein the first aperture is proximally spaced on the body portion relative to the second aperture.

21. A method of positioning sutures across a vascular opening in a vessel wall, comprising:

providing a vascular closure device having a body portion, an anchor assembly, at least one length of suture, and a plurality of needles, the anchor assembly including a hub, an actuator wire, and a pre-formed wire having a distal end connected to the actuator wire, the pre-formed wire being J-shaped;

inserting the anchor assembly and the at least one length of suture through the vascular opening;

withdrawing the actuator wire to advance a proximal end of the pre-formed wire from a first position within the hub to a second position external to the hub through a sidewall of the hub;

capturing a portion of the vessel wall between the pre-formed wire and a distal end of the body portion;

advancing the plurality of needles from an exterior of the vessel wall through the portion of the vessel wall adjacent to the vascular opening and into an interior of the vessel wall;

connecting the plurality of needles to the at least one length of suture distal to the pre-formed wire by positioning the plurality of needles through an external surface of the hub;

withdrawing the plurality of needles to position the at least one length of suture through the vessel wall adjacent to the vascular opening;

advancing the actuator wire to move the pre-formed wire into the hub;

removing the anchor assembly through the vascular opening;

providing a plurality of pre-formed wires that each extend through a separate wire aperture in the sidewall of the hub.

22. A vascular closure device, comprising:

a body portion;

a hub positionable through a puncture in a vessel and having first and second apertures defined in a sidewall thereof;

a wire assembly including an actuator wire extending through the body portion and hub, the actuator wire comprising a groove, the groove extending along a length dimension of the actuator wire, a first anchor wire and a second anchor wire, the first anchor wire having a distal end connected to the actuator wire in the groove and a proximal end movable from a first position within the hub to a second position extending out of the at least one aperture to capture a portion of a wall of the vessel between the anchor wire and the body portion upon withdrawal of the actuator wire, the body portion having a distally facing surface configured to abut tissue external to the vessel wall;

first and second suture members configured to be positioned within the vessel;

first and second pairs of needles operable to advance from an exterior of the vessel through the portion of the vessel adjacent to the puncture and into an interior of the vessel wall, connect to the first and second suture members at a position distal to the first and second anchor wires by extending through an outer surface of the hub, and be withdrawn through the portion of the vessel to position the first and second suture members through the portion of the vessel;

wherein the first and second anchor wires are configured to extend through first and second apertures defined in the sidewall of the hub.