Multiple-firing crimp device and methods for using and manufacturing same

• US 10,016,193 B2
• Filed: 11/17/2014
• Issued: 07/10/2018
• 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
• Assistant Examiner(s): SCHWIKER, KATHERINE H
• Application Number:
  US14/543,240
• Publication Number:
  US 20150142021A1
• Time in Patent Office: 1,331 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 for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• 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 for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• 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 suture fixation system, comprising:

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

a hollow shaft having a distal fixation location, an exterior surface, and an interior;

the plurality of suture fixation clips stacked in the interior and configured to move along a longitudinal axis;

the shaft defining a lateral opening proximal to the distal fixation location;

the lateral opening communicating between the interior and an environment outside the exterior surface;

an elongated device movement carriage within the interior of the shaft;

the plurality of suture fixation clips movably mounted on the device movement carriage, the device movement carriage being configured to deliver one suture fixation clip to the distal fixation location by moving the one suture fixation clip longitudinally from a proximal position into the distal fixation location;

a user-movable shuttle having a snare, the snare configured to laterally pass into the interior of the shaft through the lateral opening from the environment outside the exterior surface, the snare configured to pass through the internal opening of the one suture fixation clip when the one suture fixation clip is at the distal fixation location, and the snare configured to laterally pass out from the interior of the shaft through the lateral opening into the environment outside the exterior surface; and

the shuttle comprising a body defining a lumen surrounding the shaft, the shuttle configured to longitudinally translate on the shaft, the shuttle configured to move the snare from proximal of the one suture fixation clip through the one suture fixation clip to a position distal of the one suture fixation clip, wherein in the position distal of the one suture fixation clip the at least one suture is temporarily secured in the snare;

the shuttle configured to pull a portion of the at least one suture temporarily secured in the snare proximally through the one suture fixation clip and out a 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.

2. The suture fixation system according to claim 1, which further comprises a fixing device with opposing surfaces contacting the one suture fixation clip, the fixing device having a control device that, when actuated, fixes the one suture fixation clip onto the at least one suture within the distal fixation location.

3. The suture fixation system according to claim 2, wherein after fixing the one suture fixation clip, the device movement carriage moves to a second proximal position such that the interior is open to the environment through the lateral opening.

4. The suture fixation system according to claim 3, wherein the proximal position is the same as the second proximal position.

5. The suture fixation system according to claim 3, wherein, the proximal position is different from the second proximal position.

6. The suture fixation system according to claim 3, wherein, during or after the device movement carriage is in the process of moving to the second proximal position without the one suture fixation clip, the device movement carriage moves a previously second of the plurality of suture fixation clips into a loading position to become a new one suture fixation clip.

7. The suture fixation system according to claim 1, which further comprises a cutting assembly having a cutting control device that, when actuated, cuts the portion of the at least one suture adjacent the one suture fixation clip.

8. The suture fixation system according to claim 1, wherein:

the portion of the at least one suture temporarily secured in the snare is two free ends of a surgical suture;

the portion of the at least one suture secured in the snare and being pulled proximally through the one suture fixation clip is the two free ends such that, at a given time, four lengths of the surgical suture are being pulled through the one suture fixation 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 surgical suture.

9. The suture fixation system according to claim 1, wherein the internal opening of the suture fixation clip is a slot.

10. The suture fixation system according to claim 1, wherein the plurality of suture fixation clips are crimp sleeves having a hollow through bore.

11. The suture fixation system according to claim 1, wherein:

the shaft has a distal end that acts as a distal cam driver; and

the device movement carriage comprises an exterior-threaded carriage, the exterior-threaded carriage is movably disposed inside the shaft along the longitudinal axis towards and away from the distal end of the shaft and the exterior-threaded carriage has a carriage distal end at which is disposed the one suture fixation clip.

12. The suture fixation system according to claim 11, wherein each of the plurality of suture fixation clips has an interior thread and is threaded on the exterior-threaded carriage at a spacing from one another such that rotation of the device movement carriage in a direction selectively carries the one suture fixation clip off the carriage distal end.

13. The suture fixation system according to claim 12, which further comprises:

a hammer movably disposed inside the shaft adjacent the distal end of the shaft, the hammer having a cam surface operatively connected to the distal end of the shaft to move the hammer towards and away from the longitudinal axis of the shaft when the shaft is moved along the longitudinal axis;

an anvil at least partially disposed inside the shaft adjacent the distal end of the shaft and opposite the hammer; and

wherein the distal fixation location is between the hammer and the anvil.

14. The suture fixation system according to claim 13, wherein the snare has a loop shaped to extend through an interior of the carriage and pass through the internal opening of the one suture fixation clip.

15. The suture fixation system according to claim 13, which further comprises a cutting assembly having:

a cutter within the shaft extending parallel to the longitudinal axis and shaped to cut the at least one suture adjacent the one suture fixation clip; and

a cutter control device connecting the cutter to the shaft to have the cutter move and cut the at least one suture adjacent the one suture fixation clip when the shaft is at a distal position with respect to one of the hammer and the anvil.

16. The suture fixation system according to claim 1, wherein:

the one suture fixation clip has a proximal end; and

the user-movable shuttle has a hollow snare guide, at least a distal portion of the snare is disposed in the snare guide, the snare guide is disposed external to the shaft and is configured to move distally through the lateral opening to a position adjacent the proximal end of the one suture fixation clip;

the user-movable shuttle further comprising a snare extension device configured to move at least the distal portion of the snare distally through the snare guide, through the one suture fixation clip, and past the distal fixation location of the shaft to the position distal of the one suture fixation clip, the snare is configured to be retracted to pull at least the portion of the at least one suture through the one suture fixation clip and out the lateral opening.

17. The suture fixation system according to claim 16, wherein, when the snare guide is moved distally through the lateral opening, the snare guide moves up to the proximal end of the one suture fixation clip.

18. The suture fixation system according to claim 1, which further comprises a cutting assembly having a cutter within the shaft extending parallel to the longitudinal axis and shaped to cut the at least one suture adjacent the one suture fixation clip.

20. The suture fixation system according to claim 1, wherein the internal opening of the suture fixation clip is a lumen.

19. A multiple-firing suture fixation system, comprising:

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

a hollow shaft having a distal fixation location, an exterior surface, and an interior;

the plurality of suture fixation clips stacked in the interior and configured to move along a longitudinal axis;

the shaft defining a lateral opening proximal to the distal fixation location;

the lateral opening communicating between the interior and an environment outside the exterior surface;

an elongated device movement carriage within the interior of the shaft;

the plurality of suture fixation clips movably mounted on the device movement carriage, the device movement carriage being configured to deliver one suture fixation clip to the distal fixation location by moving the one suture fixation clip longitudinally from a proximal position into the distal fixation location, the one suture fixation clip having a proximal end;

a user-movable shuttle having a snare;

the snare configured to laterally pass into the interior of the shaft through the lateral opening from the environment outside the exterior surface, the snare configured to pass through the internal opening of the one suture fixation clip when the one suture fixation clip is at the distal fixation location, and the snare configured to laterally pass out from the interior of the shaft through the lateral opening into the environment outside the exterior surface;

the shuttle comprising a body and a hollow snare guide, at least a distal portion of the snare being disposed in the snare guide, the snare guide being disposed external to the shaft and configured to move distally through the lateral opening to a position adjacent the proximal end of the one suture fixation clip; and

the body defining a lumen surrounding the shaft;

the shuttle configured to longitudinally translate on the shaft, the shuttle configured to move the snare in a distal direction through the snare guide from proximal of the one suture fixation clip through the one suture fixation clip to a position distal of the one suture fixation clip, wherein in the position distal of the one suture fixation clip the at least one suture is temporarily secured in the snare;

the shuttle configured to pull a portion of the at least one suture temporarily secured in the snare proximally through the one suture fixation clip and out a 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.