IP Library › Granted Patent US 12,251,097
Granted Patent B2
US 12,251,097 · App. 17/455,215 · Granted Mar 18, 2025

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

Inventors: Derek Dee Deville (Coral Gables, FL); Kevin W. Smith (Coral Gables, FL); Michael Walter Kirk (Miami, FL); Carlos Rivera (Cooper City, FL); George Nunez (Miami, FL); Thomas O. Bales, Jr. (Miami, FL); Korey Kline (Miami, FL); Matthew A. Palmer (Miami, FL); M. Sean McBrayer (Miami, FL); Richard George Cartledge (Boca Raton, FL); Max Pierre Mendez (Miami, FL); Kevin K. Dang (Garden Grove, CA); Bryan A. Janish (Huntington Beach, CA); Manouchehr A. Miraki (Laguna Hills, CA)
Assignee: Edwards Lifesciences AG
A61B17/0485A61B17/0467A61B17/0487A61B2017/00017A61B2017/00119A61B2017/00349A61B2017/00358A61B2017/00398A61B2017/00477A61B2017/00734A61B2017/00876A61B2017/00902A61B2017/0488A61B2017/0496A61B2090/064A61B2090/0807A61B2090/309A61B2090/3937
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Quick Facts
Patent No.
US 12,251,097
App. No.
17/455,215
Granted
Mar 18, 2025
Kind
B2
Abstract

A multiple-firing clip device includes a hollow shaft defining a lateral opening communicating with an environment and a distal shaft portion between the lateral opening and a distal end opening. A shuttle longitudinally moves on the shaft and comprises a shuttle body defining a lumen surrounding the shaft, a snare, and a snare-extender slide defining a snare track to form a snare travel path in which the snare is disposed from the body and through the track and a portion of the body. The slide moves along a given extent defining a slide distance and a distal end and movement of the slide to the distal end shortens the snare travel path to extend the snare portion through the lateral opening, through the distal shaft portion, and distally out from a distal side of the body longer than the given extent to secure a suture with the snare.

Claims (81)

1. A multiple-firing clip device, comprising:

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

a plurality of suture fixation clips each having an internal hollow shaped to receive therein at least one suture, the plurality of the suture fixation clips stacked in the interior, defining a first clip, and configured to move along a longitudinal axis;

a clip movement assembly within the interior of the shaft and configured to deliver the first clip to the distal clip fixation location by moving the first clip longitudinally from a first proximal position into the distal clip fixation location; and

a snare assembly longitudinally movable on the shaft and comprising:

a snare-movement body comprising a hollow, snare-guiding tube having a distal tube end;

a snare operatively connected to the snare-movement body and having a distal snare portion; and

an interior body defining a portion of a snare guide path aligned with the snare-guiding tube to form a snare travel path; the snare being disposed within the snare guide path from the snare-movement body, through the interior body portion of the snare guide path, and into the snare-guiding tube; the interior body being movably disposed with respect to the snare-movement body to shorten the snare travel path and thereby extend the distal snare portion out from the distal tube end, through the lateral opening, through the distal clip fixation location, through the internal hollow of the first clip, and distally out from the distal shaft end to a given distance for temporarily securing at least a portion of the at least one suture.

2. The device according to claim 1 , wherein:

the snare has a proximal end;

the snare-movement body has a snare-movement body portion of the snare guide path;

the snare-movement body portion of the snare guide path is aligned with the interior body portion of the snare guide path and with the snare-guiding tube to form the snare travel path;

the snare-movement body comprises a grounding area at which the proximal end of the snare is fixed;

the snare is disposed within a path from the grounding area, through the interior body portion of the snare guide path, through the snare-movement body portion of the snare guide path, and into the snare-guiding tube; and

the interior body is movably disposed with respect to the snare-movement body to shorten the snare travel path and thereby extend the distal snare portion out from the distal tube end.

3. The device according to claim 2 , wherein the interior body portion of the snare guide path has a first U-turn bend and the snare-movement body portion of the snare guide path has a second U-turn bend.

4. The device according to claim 3 , wherein:

the snare-guiding tube comprises a proximal guiding-tube opening;

the interior body portion of the snare guide path comprises a proximal portion aligned with a proximal end of the first U-turn bend, and a distal portion aligned with a distal end of the first U-turn bend;

the snare-movement body comprises a first tube fixed thereto to move correspondingly with the snare-movement body; a distal end portion of the first tube is aligned with the proximal portion of the interior body portion of the snare guide path to extend therewithin and retract therefrom as the interior body moves; the first tube has a proximal portion comprising the proximal snare ground in which the proximal end of the snare is fixed;

the snare-movement body portion of the snare guide path has a proximal portion aligned with a proximal end of the second U-turn bend;

a distal end portion of a second tube is disposed within the proximal portion of the snare-movement body portion of the snare guide path, and a proximal end portion of the second tube is disposed within the distal portion of the interior body portion of the snare guide path, the second tube extendable and retractable with movement of the interior body; and

the snare extends from the proximal snare ground distally out the first tube, through the first U-turn bend, through the second tube, through the second U-turn bend, through the proximal guiding-tube opening, and through at least a portion of the snare-guiding tube.

5. The device according to claim 1 , wherein:

the snare has a proximal end; and

the interior body has a proximal snare ground at which the proximal end of the snare is fixed.

6. The device according to claim 5 , wherein the portion of the snare guide path of the snare movement body has a U-turn bend.

7. The device according to claim 6 , wherein:

the portion of the snare guide path of the snare movement body comprises a proximal portion and a distal portion;

the interior body comprises a tube:

comprising a proximal portion fixed at the interior body;

comprising the proximal snare ground in which the snare is fixed; and

aligned with the proximal portion of the portion of the portion of the snare guide path of the snare movement body to extend therewithin and retract therefrom as the interior body moves;

the snare-guiding tube comprises a proximal guiding-tube opening aligned with the distal portion of the portion of the snare guide path of the movement body to extend therewithin and retract therefrom as the snare-movement body moves; and

the snare extends from the proximal snare ground distally out the tube, through the U-turn bend, through the proximal guiding-tube opening, and through at least a portion of the snare-guiding tube.

8. The device according to claim 1 , wherein:

the shaft comprises a distal shaft portion between the lateral opening and the distal shaft end; and

the snare assembly is configured to pull a portion of the at least one suture temporarily secured in the snare from distal of the distal shaft end proximally through the internal hollow of the first clip, through the distal shaft portion, and out a side of the shaft through the lateral opening.

9. The device according to claim 8 , wherein:

the snare has a proximal end;

the snare-movement body moves between a proximal-most position and a distal-most position; and

the internal body has a proximal snare ground at which the proximal end of the snare is fixed such that, as the snare-movement body moves to the distal-most position, the distal snare portion extends through the distal shaft portion, through the distal clip fixation location, through the internal hollow of the first clip, and distal of the distal shaft end.

10. The device according to claim 1 , wherein:

the snare-movement body moves between a proximal-most position and a distal-most position along a slide distance; and

the snare assembly is configured to extend at least the distal snare portion distally to an extent that is longer than the slide distance responsive to movement of the snare-extender slide up to the distal-most position.

11. The device according to claim 1 , wherein the snare guide path is configured such that an approximately one inch movement of the snare-extender slide causes approximately two and one-half inches of snare extension.

12. The device according to claim 1 , wherein:

the snare is configured to laterally pass into the interior of the shaft through the lateral opening from the environment, 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 clip fixation location to temporarily secure a suture portion of the at least one suture within the snare; and

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

13. The device according to claim 12 , wherein:

the suture portion temporarily secured in the snare comprises two free ends of a surgical suture;

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

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

14. The device according to claim 1 , wherein the internal hollow is one of a lumen and a slot.

15. The device according to claim 1 , wherein the clip movement assembly is configured to deliver the first clip to the distal clip fixation location by moving the first clip longitudinally from the first proximal position into the distal clip fixation location and returning without the first clip to a second proximal position one of:

substantially the same as the second proximal position; and

different from the first proximal position.

16. The device according to claim 15 , wherein, during or after the clip movement assembly is in the process of returning to the second proximal position without the first clip, the clip movement assembly moves a previously second of the clips into a clip loading position to become a new first clip.

17. The device according to claim 1 , wherein:

the first clip has a proximal side;

the snare-guiding tube has a distal guide portion movable from external of the shaft into the interior through the lateral opening and up to the proximal side of the first clip;

the distal snare portion is steady with respect to the snare-guiding tube when the distal guide portion is external to the shaft; and

the distal snare portion is configured to extend from the snare-guiding tube responsive to locating the distal guide portion within the interior.

18. The device according to claim 1 , wherein the snare-movement body defines a lumen surrounding the shaft.

19. The device according to claim 1 , wherein the distal snare portion has a loop shaped to extend through the interior of the shaft through the lateral opening from the environment, to pass through the internal hollow of the first clip, and to pass out of the interior of the shaft distally past the distal clip fixation location and to open for temporarily securing at least the portion of the at least one suture within an opening of the loop.

20. The device according to claim 19 , wherein:

the snare-movement body has a distal side;

the interior body has a proximal-most, actuated position and a distal-most, unactuated position;

the distal tube end is adjacent the distal side of the snare assembly when in the distal-most, unactuated position; and

the snare has a tip and an overall length set to position the tip just outside the distal side of the snare-movement body when the interior body is in the proximal-most, actuated position.

21. The device according to claim 20 , wherein the snare-extension tube is configured to drop into the lateral opening of the shaft as the snare assembly moves towards the distal shaft end.

22. A multiple-firing clip device, comprising:

a hollow shaft comprising an exterior surface, an interior configured to receive therein a stack of suture fixation clips, and a distal end opening shaped to eject at least one of the suture fixation clips therefrom; the shaft defining a lateral opening communicating between the interior and an environment outside the exterior surface; the shaft defining a distal shaft portion between the lateral opening and the distal end opening; and

a snare assembly longitudinally movable on the shaft and comprising:

a snare-movement body defining a lumen surrounding the shaft and comprising a distal side;

a snare operatively connected to the snare-movement body and having a distal snare portion; and

an interior body, the interior body:

defining a portion of a snare guide path in which the snare is disposed from a shuttle body, through the interior body, and through at least a portion of the snare-movement body;

being movably disposed with respect to the snare-movement body along a given extent;

the given extent defining a slide distance and a distal end; and

responsive to movement of the interior body to the distal end, shortening the snare travel path and thereby extending the distal snare portion through the lateral opening, through the distal shaft portion, and distally out from the distal side to a distance longer than the given extent for temporarily securing at least a portion of the at least one suture with the snare.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 11, 2025
From: DEVILLE, DEREK DEE; SMITH, KEVIN W.; KIRK, MICHAEL WALTER; RIVERA, CARLOS; NUNEZ, GEORGE; BALES, THOMAS O., JR.; KLINE, KOREY; PALMER, MATTHEW A.; MCBRAYER, M. SEAN; CARTLEDGE, RICHARD GEORGE; MENDEZ, MAX PIERRE
To: SYNTHEON CARDIOLOGY, LLC
Reel/Frame 070186/0110 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 11, 2025
From: SYNTHEON CARDIOLOGY, LLC
To: EDWARDS LIFESCIENCES AG
Reel/Frame 070186/0145 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 11, 2025
From: DANG, KEVIN K.; JANISH, BRYAN A.; MIRAKI, MANOUCHEHR A.
To: EDWARDS LIFESCIENCES AG
Reel/Frame 070186/0168 →
Continuity (7)
Continuation 16355373 · Mar 15, 2019
Continuation 14965323 · Dec 10, 2015
Provisional Application 62164016 · May 20, 2015
Provisional Application 62103045 · Jan 13, 2015
Provisional Application 62096749 · Dec 24, 2014
Provisional Application 62090097 · Dec 10, 2014
Related Publication 20220071619A1 · Mar 10, 2022
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