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SOFT TISSUE FIXATION SYSTEM

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  • Publication Date:
    June 6, 2024
  • معلومة اضافية
    • Document Number:
      20240180545
    • Appl. No:
      18/444132
    • Application Filed:
      February 16, 2024
    • نبذة مختصرة :
      The present disclosure includes a single delivery needle configuration which can accompany multiple soft tissue fixation devices at once. The configuration eliminates the need to reload a fixation delivery device when multiple fixation devices are required. Further, this configuration can include different variations of fixation devices. In embodiments, these presently disclosed fixation devices are typically manufactured from standard braided polyester suture that is cut into segments with predetermined lengths. This design allows the braided suture segments to be preloaded with a suture threaded through the preloaded braided suture segments with a slip knot placed on the proximal end of a first braided suture segments (e.g., distal fixation device). The tailing suture from the slip knot passes thru the second, third, fourth braided suture segments, or any required quantity of braided suture segments that have been preloaded into the delivery device. The suture passes completely thru a delivery device.
    • Claim:
      1. A flexible braided anchor assembly for tissue fixation, comprising: a flexible strand; and a plurality of flexible braided anchor segments slidably coupled to the flexible strand, the flexible strand passing through a bore hole that traverses from a proximal end to a distal end of each of the plurality of braided anchor segments such that the proximal end of a first braided anchor segment is adjacent to a distal end of a second braided anchor segment; wherein the plurality of braided anchor segments are cinched together forming a cinched flexible braided anchor assembly to provide tissue fixation.
    • Claim:
      2. The assembly of claim 1, wherein each of the plurality of braided anchor segments comprise straight braided suture segments that have been deformed by application of tension on the flexible strand.
    • Claim:
      3. The assembly of claim 1, wherein the flexible strand comprises a monofilament.
    • Claim:
      4. The assembly of claim 1, wherein the flexible strand comprises a suture.
    • Claim:
      5. The assembly of claim 4, wherein the suture comprises a braided polyester suture.
    • Claim:
      6. The assembly of claim 1, wherein each of the plurality of braided anchor segments comprise standard braided polyester suture that is cut into predetermined lengths.
    • Claim:
      7. The assembly of claim 1, wherein the cinched plurality of braided anchor segments has a purse string effect on the plurality of braided anchor segments such that the plurality of flexible braided anchor segments is gathered to provide tissue fixation.
    • Claim:
      8. A method for implanting a plurality of braided suture segments connected with a closure device via a single flexible strand for tissue fixation, comprising; puncturing the tissue at a first location with a delivery needle; extruding a first braided suture segment from the delivery needle by squeezing together a first loop and a second loop of a closure handle assembly, the first braided suture segment is the first of a plurality of braided suture segments slidably coupled to a flexible strand, the flexible strand being threaded through a bore hole in the first braided suture segment; pulling the flexible strand a first time to deform the first braided suture segment forming the first suture loop track, pulling the flexible strand the first time tightens a slipknot around a proximal end of the first braided suture segment, tightening the slipknot is configured to anchor the first braided suture segment to the tissue to prevent the first braided suture segment from pulling thru the tissue; withdrawing the delivery needle from the tissue a first time; puncturing the tissue at a second location with the delivery needle; extruding a second braided suture segment from the delivery needle by advancing a third drive, advancing the third drive utilizes an inner drive tube to push the second braided suture segment out of a nitinol inner tube; pulling the suture a second time to deform the second braided suture segment forming the second suture loop track; withdrawing the delivery needle from the tissue a second time; pulling the suture a third time, the pulled suture causing the second suture loop track to be moved toward the first suture loop track; securing the suture to keep the tissue fixated by the plurality of braided suture segments; and cutting the suture, the suture is cut a distance away from the proximal end of a final suture loop track of the plurality of the suture loop tracks.
    • Claim:
      9. The method of claim 8, following pulling the suture a third time, and before securing the suture, further comprising: puncturing the tissue at a third location with the delivery needle; extruding a third braided suture segment from the delivery needle by advancing the third drive a second time; pulling the suture a fourth time to deform the third braided suture segment forming the third suture loop track; withdrawing the delivery needle from the tissue a third time; and pulling the suture a fourth time, the pulled suture causing the third suture loop track to be moved toward the second suture loop track.
    • Claim:
      10. The method of claim 8, wherein: the first braided suture segment is a primary first braided suture segment; squeezing together the first loop and the second loop of a closure handle assembly advances the nitinol inner tube to push the first braided suture segment out of the delivery needle; and after advancing nitinol inner tube to push the first braided suture segment out of the delivery needle, nitinol inner tube remains in an advanced position temporarily.
    • Claim:
      11. The method of claim 8, wherein the extruding the second braided suture segment is accomplished by advancing nitinol drive tube to push the second braided suture segment out of the delivery needle.
    • Claim:
      12. The method of claim 8, further comprising: rotating the third drive, prior to extruding a second braided suture segment from the delivery needle, 90 degrees counterclockwise until it stops and shows the number 2.
    • Claim:
      13. The method of claim 8, wherein the securing the suture comprises a locking device or an overhead knot that can be run down to a fixation site.
    • Claim:
      14. The method of claim 8, wherein the securing the suture comprises locking the suture in place using a locking mechanism comprising at least one of a tag, a barb, a cinch, a toggled needle, or a distel knot.
    • Claim:
      15. A surgical device for implanting a flexible braided anchor assembly for tissue fixation, comprising: a closure handle assembly comprising: a first loop; a second loop; and a third drive; a cylindrical bore passing through the closure handle assembly on a center axis along a length of the closure handle assembly; a peek outer tube positioned in the cylindrical bore of the closure handle assembly, the peek outer tube being hollow and having a common center line with the cylindrical bore of the closure handle assembly, the peek outer tube comprising a delivery needle having a needle tip at a distal end of the peek outer tube; a plurality of braided suture segments slidably coupled to a flexible strand, the flexible strand being translationally threaded through plurality of braided suture segments; a nitinol inner tube positioned in the peek outer tube and having a common center line with the peek outer tube, the nitinol inner tube configured to extrude a first braided suture segment; and an inner drive tube positioned in the nitinol inner tube and having a common center line with the nitinol inner tube, the inner drive tube configured to extrude remaining braided suture segments of the plurality of braided suture segments, wherein the remaining braided suture segments of the plurality of braided suture segments are translationally threaded through and pressure fit within a detent in the inner drive tube.
    • Claim:
      16. The surgical device of claim 15, wherein each of plurality of braided suture segments comprises a hollow braided suture segment.
    • Claim:
      17. The surgical device of claim 15, wherein: the suture comprises a monofilament strand; and the plurality of braided suture segments comprises a plurality of hollow braided suture segments aligned end to end having the monofilament strand threaded through the aligned plurality of hollow braided suture segments.
    • Claim:
      18. The surgical device of claim 15, wherein a column strength of the plurality of hollow braided suture segments is increased by application of at least one of heat or a cyanoacrylate coating to each of the segments of the plurality of hollow braided suture segments.
    • Claim:
      19. The surgical device of claim 15, wherein a braided suture segment of the plurality of braided suture segments has a length of between about 5 mm and about 50 mm.
    • Claim:
      20. The surgical device of claim 16, wherein each of the braided suture segments of the plurality of braided suture segments has a length of between about 5 mm and about 12 mm.
    • Claim:
      21. The surgical device of claim 18, wherein a distal end of the flexible strand threaded thru the first braided suture segment is looped around the first braided suture segment and knotted around the flexible strand between the first braided suture segment and the first drive tube.
    • Claim:
      22. The surgical device of claim 15, wherein each of the plurality of braided suture segments is treated to increase a rigidity of the plurality of braided suture segments slidably coupled to the flexible strand.
    • Claim:
      23. The surgical device of claim 22, wherein the treatment comprises: heating each of the plurality of braided suture segments; or applying a cyanoacrylate coating to each of the plurality of braided suture segments.
    • Current International Class:
      61; 61
    • الرقم المعرف:
      edspap.20240180545