Multiple-firing suture fixation device and methods for using and manufacturing same

• US 10,327,758 B2
• Filed: 09/29/2015
• Issued: 06/25/2019
• Est. Priority Date: 11/18/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Smith, Kevin W., Mendez, Max Pierre, Palmer, Matthew A., McBrayer, M. Sean, Bales, Jr., Thomas O., Deville, Derek Dee, Cartledge, Richard, Kline, Korey, Rivera, Carlos, Nunez, George
• Primary Examiner(s): Erezo, Darwin P
• Assistant Examiner(s): Schwiker, Katherine H
• Application Number:
  US14/868,741
• Publication Number:
  US 20160038137A1
• Time in Patent Office: 1,365 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/0053 Loading magazines or sutures into applying tools
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0438 slotted, i.e. having a longitudinal slot for enhancing their elasticity
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2090/309 using white LEDs

Abstract

A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Claims

1. A multiple-firing clip device, comprising:

a plurality of suture fixation clips each having an internal hollow shaped to receive therein at least one suture;

a shaft defining a hollow interior and comprising an exterior surface and a distal fixation location in the interior;

the plurality of the clips stacked in the interior, defining a first clip, and being configured to move along a longitudinal axis;

the shaft defining a lateral opening proximal to the distal fixation location and communicating between the interior and an environment outside the exterior surface;

an elongated device movement carriage at least partly disposed within the interior of the shaft;

the device movement carriage being configured to deliver the first clip to the distal fixation location by moving the first clip longitudinally from a first proximal position into the distal fixation location and returning to a second proximal position without the first clip; and

a shuttle defining a lumen surrounding the shaft and longitudinally movable on the shaft to a distal-most position;

the shuttle comprising a body and a snare movably disposed within the body to deploy distally out therefrom;

the shuttle configured to pull a portion of the at least one suture to be captured by the snare from distal of the first clip proximally through the first clip, through a portion of the shaft, and out a side of the shaft through the lateral opening;

the shuttle comprising an interlock configured to prevent the body from moving with respect to the shaft during deployment of the snare and to prevent the snare from deploying until the shuttle is in the distal-most position.

2. The device according to claim 1, wherein the internal hollow is one of:

a lumen; and

a slot.

3. The device according to claim 1, wherein the first proximal position is different from the second proximal position.

4. The device according to claim 1, wherein the first proximal position is the same as the second proximal position.

5. The device according to claim 1, wherein, responsive to the device movement carriage returning to the second proximal position, the interior is open to the environment through the lateral opening.

6. The device according to claim 1, wherein, during or after the device movement carriage is returning to the second proximal position without the first clip, the device movement carriage moves a previously second of the clips into the distal fixation location to become a new first clip.

7. The device according to claim 1, wherein the body has a distal side and the snare is movably disposed within the body to extend distally out the distal side.

8. The device according to claim 1, wherein:

the snare is configured to laterally pass into the interior of the shaft through the lateral opening, is configured to pass through the internal hollow of the first clip, and is configured to pass out of the interior of the shaft distally past the distal fixation location; and

the shuttle is configured to pull the portion of the at least one suture out the side of the shaft through the lateral opening to present at least some of the portion of the at least one suture out from the lateral opening for access by a user.

9. The device according to claim 8, wherein:

the portion of the at least one suture is two free ends of a surgical suture;

the portion of the at least one suture pulled proximally through the first clip is the two free ends such that, at a given time, four lengths of the at least one suture are pulled through the first clip; and

the at least some of the portion of the at least one suture pulled out through the lateral opening for access by a user is the two free ends of the at least one suture.

10. The device according to claim 1, wherein the interlock holds the body at the distal-most position while the snare is moved.

11. The device according to claim 1, wherein the interlock is configured to prevent the body from moving with respect to the shaft while the snare is extended.

12. The device according to claim 1, wherein the snare is movably disposed to extend and retract during deployment and the interlock is configured to prevent the body from moving with respect to the shaft while the snare is extending or retracting.

13. The device according to claim 1, wherein the snare is movably disposed to extend and retract during deployment and the interlock is configured to prevent the body from moving with respect to the shaft until the snare is fully retracted.

14. The device according to claim 1, wherein:

the body is configured to longitudinally move back and forth along the shaft;

the shuttle comprises a snare extender operatively connected to the snare;

the snare is movably disposed within the body to extend distally out therefrom and retract back into the body by movement of the snare extender with respect to the body; and

the interlock is configured to automatically prevent the body from moving with respect to the shaft during deployment of the snare and to automatically prevent the snare from deploying until the shuttle is in the distal-most position.

15. A multiple-firing clip device, comprising:

a plurality of suture fixation clips each having an internal hollow shaped to receive therein at least one suture;

a shaft defining a hollow interior and comprising an exterior surface and a distal fixation location in the interior;

the plurality of the clips stacked in the interior, defining a first clip having a proximal side, and being configured to move along a longitudinal axis;

the shaft defining a lateral opening proximal to the distal fixation location and communicating between the interior and an environment outside the exterior surface;

an elongated device movement carriage at least partly disposed within the interior of the shaft;

the device movement carriage being configured to deliver the first clip to the distal fixation location by moving the first clip longitudinally from a first proximal position into the distal fixation location and returning to a second proximal position without the first clip;

a shuttle longitudinally movable on the shaft to a distal-most position and comprising a body, a snare-extension tube disposed at least partly within the body, and a snare movably disposed within the body to deploy distally out from the body;

the shuttle configured to pull a portion of the at least one suture to be captured by the snare from distal of the first clip proximally through the first clip, through a portion of the shaft, and out a side of the shaft through the lateral opening;

the shuttle comprising an interlock configured to prevent the body from moving with respect to the shaft during deployment of the snare and to prevent the snare from deploying until the shuttle is in the distal-most position; and

wherein the snare comprises a snare portion disposed within the snare-extension tube;

the snare-extension tube comprises an end portion and is external to the shaft;

responsive to the snare-extension tube moving distally with the shuttle, at least the end portion of the snare-extension tube passes through the lateral opening and up to the proximal side of the first clip; and

the body further comprises a snare extender configured to move at least a portion of the snare distally through the snare-extension tube, through the first clip, and past the distal fixation location of the shaft to secure the portion of the at least one suture temporarily and to pull at least the portion of the at least one suture through the first clip and towards the lateral opening.

16. The device according to claim 15, wherein:

the snare has a loop shaped to extend through the snare-extension tube, through the distal fixation location of the shaft, and through the internal hollow of the first clip; and

responsive to the snare extender moving at least the portion of the snare distally through the snare-extension tube, through the first clip, and past the distal fixation location of the shaft, the loop opens to form an orifice in which the portion of the at least one suture is secured temporarily.

17. The device according to claim 16, wherein the loop is substantially ovular.

18. The device according to claim 15, wherein:

the body has a distal side;

the snare extender has a proximal-most, unactuated position; and

the snare-extension tube has a distal tube end adjacent the distal side of the body, at least some of a distal portion of the snare is disposed in the snare-extension tube and the snare has a tip and an overall length configured to position the tip just outside the distal side of the body while the snare extender is in the proximal-most, unactuated position.

19. The device according to claim 18, wherein the shaft has a distal end and the snare-extension tube is configured to drop into the lateral opening of the shaft as the shuttle moves towards the distal end of the shaft.

20. The device according to claim 15, wherein the snare is movably disposed to extend and retract during deployment.