KNOTLESS ALL SUTURE TISSUE REPAIR
20210186485 · 2021-06-24
Inventors
Cpc classification
A61B2017/00004
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
A61B2017/0462
HUMAN NECESSITIES
A61B2017/0459
HUMAN NECESSITIES
International classification
Abstract
A knotless tissue repair assembly for attachment of tissue to bone includes an anchoring implant with a length of suture threaded therethrough. The implant is preferably a soft flexible three-dimensional structure. The implant may be actuated from a first elongate low profile shape into a second short radially expanded shape having a larger diameter than the hole through which it was placed. The suture extends through the anchor, through a tissue to be secured, and back through a designated suture-binding region or passageway within the anchor enabling the suture to be secured therein and without the need for a physician to tie a knot. Further tension applied to a suture leg approximates the tissue to the anchor until a desired tension or distance between the tissue and anchor is achieved.
Claims
1. A tissue repair assembly comprising: a soft anchor defining an elongate body having a proximal end, a distal end, longitudinal axis therebetween and a maximum width extending from a first external side surface to a second external side surface; a suture interwoven repeatedly through the soft anchor, with a first and second suture tail extending from the soft anchor proximal end, a first and a second suture snare extending within a length of the suture, defining a suture locking passage along the length of the suture, wherein the suture locking passage extends perpendicularly to the soft anchor longitudinal axis; wherein the first and second snares each have a looped end configured to snare the first and second suture tails respectively, each looped end extending from opposite ends of the suture locking passage.
2. The tissue repair assembly of claim I around the first and second external side surfaces and are configured to operatively couple to the first and second suture tails respectively and draw the first and second suture tails around the soft anchor and through the suture locking passage to form two closed suture loops, each of the two closed suture loops crossing over each other within the suture locking passage and emerging at opposite ends of the suture locking passage to each other.
3. The tissue repair assembly of claim 2 wherein tensioning at least one of the suture tails causes the suture locking passage to knotlessly lock the suture.
4. The tissue repair assembly of claim 1 wherein tensioning at least one of the suture tails causes the soft anchor to change from a first configuration, in which the soft anchor is elongate, to a second configuration, in which the soft anchor maximum width is increased.
5. The tissue repair assembly of claim 2 wherein tensioning at least one of the suture tails simultaneously deploys the soft anchor and knotlessly locks the assembly.
6. The tissue repair assembly of claim 1 wherein the first snare is configured to draw the first suture tail along the first external side surface and then through the suture locking passage.
7. The tissue repair assembly of claim 6 wherein the second snare is configured to draw the second suture tail along the second external side surface, opposite the first external surface and then through the suture locking passage.
8. The tissue repair assembly of claim 1 wherein the suture locking passage extends across the soft anchor at the soft anchor distal end.
9. The tissue repair assembly of claim 1 wherein the soft anchor defines a lumen having a diameter, the maximum width including a single lumen diameter.
10. The tissue repair assembly of claim 1 wherein the first and second snares are configured to draw the first and second tails respectively in opposite directions through the suture locking passage.
11. A tissue repair assembly comprising: a soft anchor defining a tubular body having a proximal end, a distal end and a longitudinal axis extending along the tubular body, the tubular body defining a first external side surface and a second external side surface, the first and second external side surfaces on opposing sides of the soft anchor longitudinal axis; a suture threaded repeatedly through the tubular body and having a first and a second suture tail extending from the soft anchor proximal end; a first snare and a second snare extending through a suture locking passage of the suture disposed between the first and second external side surfaces; wherein the first and second snares are configured to operatively couple, one each to the first and second suture tails respectively and draw the first and second suture tails around the soft anchor and through the suture locking passage to form two closed adjustable suture loops.
12. The tissue repair assembly of claim 11 wherein the first snare is configured to draw the first suture tail along the first external side surface and then through the suture locking passage.
13. The tissue repair assembly of claim 12 wherein the second snare is configured to draw the second tail along the second external side surface and then through the suture locking passage so as to cross over the first suture tail.
14. The tissue repair assembly of claim 11 wherein both the first and second snares each include a loop end configured to snare a suture tail, the first snare loop end extending directly from a first end of the suture locking passage and the second snare loop end extending directly from another end of the suture locking passage.
15. The tissue repair assembly of claim 11 wherein the suture locking passage extends between the first and second external side surfaces at the soft anchor distal end.
16. The tissue repair assembly of claim 11 wherein the first and second snares are configured to draw the first and second tails respectively in opposite directions through the suture locking passage.
17. The tissue repair assembly of claim 11 wherein the first snare is configured to draw the first suture tail around the first and second external surfaces of the soft anchor and through the suture locking passage.
18. The tissue repair assembly of claim 17 wherein the second snare is configured to draw the second suture tail around the first and second external surfaces of the soft anchor and through the suture locking passage, in an opposite direction around the soft anchor to the first snare.
19. The tissue repair assembly of claim 11 wherein tension on the first and second tail is configured to simultaneously deploy the soft anchor and knotlessly lock the suture within the suture locking passage.
20. The tissue repair assembly of claim 11 wherein the suture is woven repeatedly through both the first and second external side surfaces.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0056] Before the present invention is described in detail, it is to be understood that this invention is not limited to particular variations set forth herein as various changes or modifications may be made to the invention described and equivalents may be substituted without departing from the spirit and scope of the invention. As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims made herein.
[0057] Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the recited order of events. Furthermore, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.
[0058] All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.
[0059] Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Last, it is to be appreciated that unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
[0060] A suture anchoring implant for securing soft tissue to bone, or tissue to tissue is described herein. In embodiments, the anchor is a soft all suture implant. A suture extends through the anchor, through a tissue to be secured, and back through a designated suture locking region or passageway within the anchor enabling the tissue to be secured and without the need for a physician to tie a knot.
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[0062] With reference first to
[0063] In a procedure, a surgeon passes the first suture end 12 through the tissue to be reattached. To pass the suture through the tissue, a wide variety of techniques may be employed including, without limitation, use of the suture passer described in U.S. Publication No. 2011/0118760 to Gregoire et al.
[0064] With reference to
[0065] The first suture end 12, which has been passed or looped around the tissue, is placed within snare 30, so that the snare may draw the first suture end between the suture braids and into the lumen of the length of suture. The first suture end 12 may be drawn along the suture lumen in a direction away from the second suture end 14 before exiting the suture lumen a short distance later. As will be described further herein, the region 32 along the suture length creates a binding interface, suture cradle, or first friction lock region when actuated.
[0066] With reference to
[0067] With reference
Soft Anchor with Plurality of Suture Locking Regions
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[0069] With reference first to
[0070] Preferably, an anchoring implant has a first pre-deployed state in which fibers are relaxed in an elongated state. The fibers of the implant are more aligned in an orientation parallel to a longitudinal axis and are generally more concentrated. In this orientation, the soft anchoring implant is generally in an elongated state and of a generally small diameter with an exemplary width or diameter “D” of 0.06″ to 0.150″ and length “L” of 0.5″ to 1.0″. The implant may be pulled and manually manipulated to achieve this configuration or the use of specialized manufacturing fixtures may be employed, such as a funnel, tube and/or pin, which may compel the implant to achieve this first configuration to better fit within an inserter tube.
[0071] In embodiments, the anchor implant is formed from a coarse braided material. The structure utilized may be a cylindrical, helically wound braid, such as the common biaxial braid. Pulling the entire braid along its length (i.e., putting the braid in tension) lengthens and narrows it. The length (L) is gained by reducing the angle between the braided threads of the wound braid at the crossing points of the threads so that the braided threads align mostly parallel, which also reduces the radial distance between opposing sides and hence the overall circumference. When counter traction occurs, the opposite action occurs, and the braid longitudinally contracts axially and expands radially, in this case by increasing the angle between the braided threads. This helically wound braid provides an advantage in that the structure can collapse and elongate naturally due to the alignment of the braids. Non-limiting examples of a soft anchoring implant include the Q-Fix™ all suture implant manufactured by ArthroCare Corporation, Texas, USA, and is generally described in U.S. Publication No. 2013/0123810.
[0072] With reference again to
[0073] However, prior to deploying the soft anchor, the plurality of suture locking zones or cradles are formed. As described further herein, the suture is fed or drawn into itself in order to form the plurality of knotless suture locking regions.
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[0079] Also shown in
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Soft Anchor with Single Suture Locking Region
[0083] The tissue repair assemblies and implants may have a plurality of suture locking regions as described above, or in embodiments, the implant may have less than a plurality of suture locking regions.
[0084] With reference to
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[0089] A suture tail is shown commencing at 183, extending along a first lateral side of the anchoring implant 182, and forming a distal loop 197 and fixation zone 196. The suture further extends along a second lateral side, opposite to the first lateral side, and exits the anchoring implant at the proximal end to form a bend 199. From bend 199, a length 198 of suture continues in the distal direction along the exterior of soft anchoring implant.
[0090] The suture end 188 is shown extending distally from the soft anchor 182. In an application, and prior to positioning the inserter tube in a bone tunnel, the suture end 188 is passed through a tissue (not shown) and fed into snare loop 190. Snare tail 192 is then pulled proximally, drawing the suture end 188 through a hollow lumen portion of the suture to form the suture locking cradle region 191 as described in
[0091] The suture loop, and or suture ends may be pulled proximally from the anchoring implant to actuate the suture lock 191, binding the suture and prohibiting the suture loop from expanding.
[0092] A pin 194 (or another stabilizing feature) may be disposed at the distal tip of inserter tube to prevent distortion of the anchoring implant during snaring or other intermediate steps of the surgical procedure. In embodiments, the pin is an elongate rigid member removably located at distal end of the inserter tube, extending in a lateral direction through the distal end of the soft anchor, and perpendicular to the axis of the inserter tube.
[0093] Once the anchoring implant is connected to the tissue, and properly loaded with the suture, the pin 194 is removed. The distal end section of the inserter tube assembly 184 is advanced into a bone hole. The inserter tube is retracted, leaving the anchor in an undeployed configuration within the hole. The anchor bone lock is actuated to secure the anchoring implant 182 in the hole as described above. The suture ends may be further pulled to approximate the tissue to a final desired position and tension.
[0094] Although the suture paths shown in
[0095] In embodiments, the suture and anchor may be made of non-absorbable or absorbable materials. Example materials for the suture and implant include, without limitation, polyester and poliglecaprone respectively.
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[0097] The second suture 204 is provided to lock the suture, and approximate the tissue to the anchor. The second suture 204 may be fed along the lateral and distal sides of the soft suture anchor, through the tissue, and back into a portion 206 of itself (outside of the anchor body) to achieve a suture lock/cradle. Except for the suture cradle portion 206 and tissue loop, the second length 204 of suture may follow the same path as the first length of the suture 202 through the anchoring implant. It is also noteworthy that in the embodiment shown in
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[0103] As described herein it is to be understood that the anchoring assemblies may vary greatly and use alternate textiles and materials.
[0104] A wide variety of anchor shapes may be used in combination with the suture-locking mechanisms described herein. For example, as shown in
Anchor with Simultaneous Bone and Suture Locking
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[0106] Suture tails 406, 408 are passed through the tissue 422. Snares 430,432 capture the tails 406, 408 and draw the tails through the suture friction zones along the anchor sidewalls.
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[0109] In particular, suture 512 extends in a downward direction, between the anchor sidewall and a wall of the bone tunnel. Suture 512 terminates at suture tail or end 514. A snare 516 extends through a suture capture zone 520 in the suture. The suture capture zone is wound about and interwoven with the anchor body 521. By pulling on snare proximal end 518, a suture length may be drawn through the suture friction zone or locking cradle 520. The suture tail is then pulled proximally as desired to lock the suture, deploy the anchor in the bone, and to further approximate the tissue.
[0110] Fixation loop 522 is provided to maintain alignment of the anchor and cradle inside the bone tunnel. Consequently, as the anchor is deployed and suture locked, the anchor body is urged into the tunnel instead of being pulled out of the tunnel.
[0111] While preferred embodiments of this disclosure have been shown and described, modifications thereof can be made by one skilled in the art without departing from the scope or teaching herein. The embodiments described herein are exemplary only and are not intended to be limiting. Because many varying and different embodiments may be made within the scope of the present inventive concept, including equivalent structures, materials, or methods hereafter thought of, and because many modifications may be made in the embodiments herein detailed in accordance with the descriptive requirements of the law, it is to be understood that the details herein are to be interpreted as illustrative and not in a limiting sense.