Suspensory fixation device
The tape and suture construct assembly with a textile reinforcement tape and suture tails, along with a clamp, addresses the challenge of securing weak or short grafts to button implant assemblies, ensuring a stable and efficient attachment in knee reconstruction surgeries.
Patent Information
- Application Number
- PCT/US2025/019855
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-03-13
- Filing Date
- 2025-03-13
- Publication Date
- 2025-09-18
AI Technical Summary
Conventional methods for securing tendons, ligaments, or tissue grafts to button implant assemblies in knee reconstruction surgeries are inadequate, as weak or torn ends can lead to further ripping or tearing, and existing techniques are often insufficient for attaching short or weak grafts to the button implant assembly.
A tape and suture construct assembly is used, comprising a textile reinforcement tape with two suture tails, one with a needle and eyelet, to secure the graft to the button implant assembly through whipstitching, aided by a clamp to elevate and organize the graft during suturing.
The assembly provides a secure and reliable attachment of the graft to the button implant assembly, reducing the risk of further damage and simplifying the surgical process.
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Figure US2025019855_18092025_PF_FP_ABST
Abstract
Description
SUSPENSORY FIXATION DEVICEBACKGROUND1. FIELD
[0001] The present disclosure relates to surgical devices, systems, and surgical procedures and, more particularly, to surgical devices, systems, and procedures for securing a graft to a button implant assembly.2. DESCRIPTION OF THE RELATED ART
[0002] Ligament and tendon reconstruction surgeries commonly require the use of a tissue graft to replace the tom ligament or tendon. In these procedures, the graft can be secured to surrounding bone using a button implant assembly by methods including tying, folding over, or directly suturing the graft to the button implant assembly.
[0003] Description of the Related Art Section Disclaimer: To the extent that specific patents / publications / products are discussed above in this Description of the Related Art Section or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents / publications / products are prior art for patent law purposes. For example, some or all of the discussed patents / publications / products may not be sufficiently early in time, may not reflect subject matter developed early enough in time, and / or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents / publications / products are discussed above in this Description of the Related Art Section and / or throughout the application, the descriptions / disclosures of which are all hereby incorporated by reference into this document in their respective entirety(ies).BRIEF SUMMARY
[0004] The inventor(s) recognize that there are potential problems and / or disadvantages with the conventional devices and methods for securing a reinforced tissue such as a tendon, ligament, or tissue graft to a button implant assembly in knee reconstruction surgeries. Broken or tom tendons and ligaments can have ends that are weak, making reconstruction difficult as further ripping or tearing of the graft can occur. In cases where a tissue graft is required, the graft must be secured to a button implant assembly but is often too short to wrap around the looped portion of the button implant assembly and too weak to be tied or sutured to the button implant assembly directly. Therefore, a need exists for a simplified and alternative approach for securely attaching a tendon, ligament, or tissue graft to a button implant assembly and an apparatus to aid in the securing.
[0005] It is therefore a principal object and advantage of embodiments of the present disclosure to provide a tape and suture construct assembly that can be used, at least in part, as a reinforcement material configured to attach a button implant assembly to a graft. The tape and suture construct assembly can be configured to be secured to a loop portion of a button implant assembly and secured to an end of a tissue graft by means such as suturing or whipstitching. As described herein, the button implant assembly can include but is not limited to the button assembly as shown and described in US 20200281712 and / or the button assembly (suspensory graft fixation device) as shown and described in US 9700403. As additionally described herein, the means of securing the button to a graft (e.g., suturing or whipstitching) can include but is not limited to the method shown and described in WO 2024211557 (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). According to an embodiment, the tape support can be made of a textile reinforcement or suture tape material and comprise two tails of suture extending therefrom. The first suture tail can be a solid limb. The second suture tail can comprise a needle at the most distal end of the second suture tail and an eyelet attached to the needle.
[0006] It is a further object and advantage to provide a method for attaching a tape and suture construct assembly to a tendon, ligament, or tissue graft. A first end of a tape support portion / tape body portion can be secured to (e.g., wrapped around, or a portion of the button implant assembly can otherwise be passed therethrough, or stitched thereto) a portion (e.g., a looped portion) of a button implant assembly that is configured to be implanted into or fixed onto surrounding bone. The tape body portion can then be placed on the tissue graft. A first suture strand extending from the first end (or a side) of the tape body portion can be inserted into an eyelet piece that has an end that is inserted or otherwise connected to a needle portion that is additionally connected to a second suture limb that extends from the second end (or a side). The needle end of the second suture limb (positioned opposite the end attached to the tape body portion) can then be used to pierce through a first / top surface of the tape support and the tissue graft. Once the needle pierces and passes through the both the tape body and the tissue graft with the first and second suture limbs, the first and second suture limbs can be separated underneath the tissue (by removing the first limb from the eyelet that is associated with the second limb) and each passed around overtop of the tissue and first / top surface of the tape support. The process can be repeated until the limbs have been threaded along at least a portion of or the entire length of the tape support (each suture (e.g., whipstitch) being separated by a space between the next suturing), forming a traditional whipstitch or suture pattern, asshould be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure.
[0007] It is a further object and advantage to provide an apparatus to aid in securing the tape and suture construct to a button implant assembly and a graft (which can be provided along or as a system or kit with the tape and suture construct, button implant assembly and / or a graft). A clamp can be provided that is removably secured to a table or surface and elevates and secures the graft, while also providing a surface for the whipstitching or other suturing to be performed during knee ligament / ACL / PCL reconstruction, for example.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0008] The present disclosure will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings. The accompanying drawings illustrate only typical embodiments of the disclosed subject matter and are therefore not to be considered limiting of its scope, for the disclosed subject matter may admit to other equally effective embodiments. Reference is now made briefly to the accompanying drawings, in which:
[0009] FIG. 1A depicts a tape and suture construct assembly connected to a button assembly, according to an embodiment of the present disclosure.
[0010] FIG. IB depicts a close-up view of the tape and suture construct assembly connected to the button assembly, according to an embodiment of the present disclosure.
[0011] FIG. 1C depicts another close-up view of the tape and suture construct assembly connected to the button assembly, according to an embodiment of the present disclosure.
[0012] FIG. ID depicts another close-up view of the tape and suture construct assembly connected to the button assembly, according to an embodiment of the present disclosure.
[0013] FIG. IE depicts another close-up view of the tape and suture construct assembly connected to the button assembly, according to an embodiment of the present disclosure.
[0014] FIG. IF depicts another close-up view of the tape and suture construct assembly connected to the button assembly, according to an embodiment of the present disclosure.
[0015] FIG. 1G depicts another close-up view of the tape and suture construct assembly connected to the button assembly, according to an embodiment of the present disclosure.
[0016] FIG. 2A depicts a step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0017] FIG. 2B depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0018] FIG. 2C depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0019] FIG. 2D depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0020] FIG. 2E depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0021] FIG. 2F depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0022] FIG. 2G depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0023] FIG. 2H depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0024] FIG. 21 depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0025] FIG. 2J depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0026] FIG. 2K depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0027] FIG. 2L depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0028] FIG. 2M depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0029] FIG. 2N depicts another step of forming the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0030] FIG. 3 A depicts a step of forming the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0031] FIG. 3B depicts a step of forming the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0032] FIG. 3C depicts a step of forming the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0033] FIG. 3D depicts a step of forming the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0034] FIG. 3E depicts a step of forming the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0035] FIG. 3F depicts a step of forming the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0036] FIG. 3G depicts a perspective view of the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0037] FIG. 3H depicts another perspective view of the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0038] FIG. 31 depicts a close-up view of the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0039] FIG. 3 J depicts another close-up view of the tape and suture construct assembly, according to an embodiment of the present disclosure.
[0040] FIG. 4A depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0041] FIG. 4B depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0042] FIG. 4C depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0043] FIG. 4D depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0044] FIG. 4E depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0045] FIG. 4F depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0046] FIG. 4G depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0047] FIG. 5 depicts the tape and suture construct assembly whipstitched to a graft and connected to the button implant assembly, according to an embodiment of the present disclosure.
[0048] FIG. 6 depicts a perspective view of an assembled fixation assistant / block clamp, according to an embodiment of the present disclosure.
[0049] FIG. 7A depicts a side view of a disassembled fixation assistant / block clamp, according to an embodiment of the present disclosure.
[0050] FIG. 7B depicts a side view of an assembled fixation assistant / block clamp, according to an embodiment of the present disclosure.
[0051] FIG. 7C depicts a rear view of the fixation assistant / block clamp, according to an alternative embodiment of the present disclosure.
[0052] FIG. 7D depicts a front view of the fixation assistant / block clamp, according to an alternative embodiment of the present disclosure.
[0053] FIG. 7E depicts another front view of the fixation assistant / block clamp, according to an alternative embodiment of the present disclosure.
[0054] FIG. 7F depicts a side view of the fixation assistant / block clamp secured to the graft, according to an alternative embodiment of the present disclosure.
[0055] FIG. 8A depicts a side view of the fixation assistant / block clamp secured to the graft, according to an alternative embodiment of the present disclosure.
[0056] FIG. 8B depicts another side view of the fixation assistant / block clamp secured to the graft, according to an alternative embodiment of the present disclosure.
[0057] FIG. 8C depicts a perspective view of the fixation assistant / block clamp, according to an alternative embodiment of the present disclosure.
[0058] FIG. 8D depicts another perspective view of the fixation assistant / block clamp, according to an alternative embodiment of the present disclosure.
[0059] FIG. 8E depicts a side view of the fixation assistant / block clamp, according to an alternative embodiment of the present disclosure.
[0060] FIG. 8F depicts another side view of the fixation assistant / block clamp, according to an alternative embodiment of the present disclosure.
[0061] FIG. 8G depicts a close-up side view of the fixation assistant / block clamp, according to an alternative embodiment of the present disclosure.
[0062] FIG. 8H depicts another close-up side view of the fixation assistant / block clamp, according to an alternative embodiment of the present disclosure.
[0063] FIG. 9 depicts a step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0064] FIG. 10A depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0065] FIG. 10B depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0066] FIG. 10C depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0067] FIG. 11 A depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0068] FIG. 1 IB depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0069] FIG. 12A depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0070] FIG. 12B depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0071] FIG. 12C depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0072] FIG. 12D depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0073] FIG. 13A depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0074] FIG. 13B depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0075] FIG. 14 depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0076] FIG. 15A depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0077] FIG. 15B depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0078] FIG. 15C depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0079] FIG. 15D depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0080] FIG. 16A depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0081] FIG. 16B depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0082] FIG. 17 depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0083] FIG. 18A depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0084] FIG. 18B depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0085] FIG. 18C depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0086] FIG. 18D depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0087] FIG. 19A depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0088] FIG. 19B depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0089] FIG. 19C depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0090] FIG. 19D depicts another step in using the fixation assistant / block clamp to secure the tape and suture construct to a graft, according to an embodiment of the present disclosure.
[0091] FIG. 20A depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0092] FIG. 20B depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0093] FIG. 20C depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0094] FIG. 20D depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0095] FIG. 21 A depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0096] FIG. 2 IB depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0097] FIG. 22A depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0098] FIG. 22B depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0099] FIG. 22C depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0100] FIG. 23A depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0101] FIG. 23B depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0102] FIG. 23C depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0103] FIG. 23D depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0104] FIG. 24A depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0105] FIG. 24B depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0106] FIG. 24C depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0107] FIG. 24D depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0108] FIG. 24E depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0109] FIG. 25A depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0110] FIG. 25B depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0111] FIG. 26A depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0112] FIG. 26B depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0113] FIG. 26C depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0114] FIG. 27A depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0115] FIG. 27B depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0116] FIG. 27C depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0117] FIG. 27D depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0118] FIG. 27E depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0119] FIG. 27F depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.
[0120] FIG. 27G depicts the tape and suture construct assembly, according to an alternative embodiment of the present disclosure.DETAILED DESCRIPTION
[0121] Aspects of the present disclosure and certain features, advantages, and details thereof, are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are sometimes omitted so as not to unnecessarily obscure the embodiments of the disclosure in detail. It should be understood, however, that the detailed description and the specific non-limiting examples, while indicating aspects of the claimed or to be claimed invention(s), are given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions, and / or arrangements, within the spirit and / or scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure.
[0122] While embodiments of the present disclosure have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by one skilled in the art that various changes in detail may be affected therein without departing from the spirit and scope of embodiments of the disclosure as defined by claims that can be supported by the written description and drawings. Further, where exemplary embodiments are described with reference to a certain number of elements or number / order of steps it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements or number / order of steps. If elements shown in a particular Figure discussed below are not specifically identified with respect to that Figure, the elements should be sufficiently identified with respect to at least one other Figure.
[0123] Referring to the figures, wherein like numerals refer to like parts throughout, there is seen in FIGS. 1A-1G, various views of a tape and suture construct assembly 100 connected to a button implant assembly 200 (FIG. 1A depicts the tape and suture construct assembly 100 connected to a button implant assembly 200; FIG. IB depicts a rear surface 102B of the tape 102 positioned over the looped end 202 of the button implant assembly 200 making up the proximal portion of the assembly 100; FIG. 1C depicts the suture limbs 104 / 106, needle 108, and eyelet 110 making up the distal portion of the assembly 100; and FIG. ID depicts a close-up view of the needle 108, eyelet 110, and two suture limbs 104 / 106). In this configuration, a first end 102-1 of a tape body portion 102 of the tape and suture construct assembly 100 can be folded over (e.g., by means of wrapping it around and stitching it together) a looped end 202 of a button implant assembly 200 (forming a surgical system including thetwo assemblies). Referring specifically to FIGS. IB- ID, two suture limbs 104 and 106 can extend from the tape and suture construct assembly 100 at the second end 102-2 of the tape body 102. The first suture limb 104 can be a solid suture limb, and the second suture limb 106 can also be solid but with a needle portion 108 at the opposite end (i.e., end opposite the end extending from the tape) with an eyelet 110 extending from the needle portion 108 adjacent to the second suture limb 106 (where the second limb is connected to the needle portion by being positioned therein and crimping or other attaching means), as shown. The eyelet 110 can be formed by creating a loop shape (e.g., elliptical, diamond, etc.) with a flexible material such as nickel titanium (nitinol) and be inserted into the needle 108 (and crimped therein or by other means of attachment). The needle 108 can be swagged or crimped onto the end of the second limb 106 and eyelet 110. In some embodiments, the needle portion 108 can be a conventional surgical needle. In some embodiments, the tape portion 102 can be a woven flat band of suture or textile material that transitions into the two suture limbs 104 and 106. In one embodiment, the tape 102 is approximately 30 mm in length. The suture limbs 104 and 106 can be formed of ultra-high molecular weight polyethylene (UHMWPE) or similar material. In one embodiment, the suture limbs 104 and 106 are approximately 24” in length and are colored differently (e.g., one blue and one black) to provide a visual differentiation, but they do not have to be.
[0124] Referring to FIGS. 2A-2N, the method of introducing the suture limbs 104 and 106 into the tape 102 is shown. In this example, the suture limbs 104 and 106 are shuttled, spliced, or connected together to form a single strand. In other words, the first suture limb 104 can be buried into an internal channel created within the second suture limb 106 so that they form one elongated strand that can allow for color transition between the single strand and increase the strength at the connection point. The way and positioning at which the limbs are connected together, as described below, allows for a color differentiation when the assembly 100 is completed, shown in FIG. IB, even though it is one singular strand. In some embodiments, a single strand with only one suture limb is used, which can be single colored or multicolored.
[0125] As shown in FIGS. 2A-2C, the suture limb 104 and 106 tails are measured so that they are long enough to be pierced through both limbs for strength, while also being short enough to reduce bulk when weaving them through the tape 102. In a preferred embodiment, the suture limbs 104 and 106 are spliced leaving approximately a 12 mm tail (see FIG. 2B, creating the shuttle 106-1 or internal channel within the limb that another limb can be positioned within). Once the second limb 106 has been spliced with a tail 106’, the first limb104 can be pierced also leaving a tail 104’. The tail 104’ of the first suture 104 can be pulled through the shuttle 106-1 of the second limb 106, optionally using a needle to provide accuracy in the amount of suture that is pulled through to splice them together (see FIG. 2D showing a needle going from left to right into the shuttle formed within the second limb, bringing the first limb into the second limb’s internal channel of suture (shuttle)). To create the next shuttle in the first limb 104, the second limb 106 can be pierced (FIG. 2E) and the tail 106’ ofthe second limb 106 can be shuttled through the first limb 104 (FIG. 2F). When the two limbs 104 and 106 are differently colored, this method can provide visual indicators when building the assembly.
[0126] Next, in FIG. 2G, the tape 102 can be folded over the looped end 202 of the button implant assembly to create the folded over portion 102’ connecting the tape 102 and the button implant assembly 200 and allowing the strands that make up the looped end 202 to slide through and within the folded over portion 102’ of the tape 102. To secure the folded over portion 102’ to the tape body 102, the first limb 104 can pierce the folded over portion 102’ on a first side 102-3 (FIG. 2G), pull the first limb 104 over the looped end 202, and pierce the first limb adjacent to (e.g., approximately 1 mm from) the transitional location (i.e., where the first limb ends and the second limb begins, allowing for the color differentiation of the two limbs if two colors are used) (FIG. 2H), pulling the first limb through so that it is secured against the tape body 102 (FIG. 21). These steps can be repeated with the second limb 106 (i.e., pierce the folded over portion 102’ with the second limb 106 at a second side 102-4 of the tape body 102, pull it over the looped end 202, pierce the second limb 106, and pull until it is secure). Having the limbs pierce themselves can advantageously provide increased suture strength at the connection point between the tape and the button assembly. In a preferred embodiment, the folded over portion 102’ makes up approximately 5 mm ofthe first end 102-1 ofthe tape body 102 and the limbs 104 and 106 pierce the folded over portion 102’ at approximately the first 2 mm of the first end 102-1 (FIG. 2J). To finish securing the limbs 104 and 106 to the tape 102, each limb 104 and 106 can be shuttled through the respective edges ofthe tape 102, similar to that of a warp strand, providing a piercing location for the suturing or whipstitching to occur and reinforcing the body of the tape 102. In this example, the first limb 104 is shuttled down the first side 102-3 ofthe tape and the second limb 106 is shuttled down the second side 102-4 ofthe tape (see FIGS. 2K-2M), exiting the back side of the tape. Both limbs 104 and 106 can be pierced through themselves at the second end 102-2 of the tape 102 (e.g., approximately 1- 2 mm from the second end of the tape) respectively which can advantageously prevent the bunching or gathering of the tape 102 during use (see FIGS. 2M-2N). The suture limbs 104and 106 are then free to extend down from the tape body 102 on their respective sides. In some embodiments, an additional strand and stitch is used to secure the folded over portion to the tape body.
[0127] An alternative embodiment of the tape 102 threaded with the suture limbs 104 and 106 is shown in FIGS. 3A-3J (FIGS. 3A-3F show various views of the suture limbs threaded into the tape and the folded over portion; FIG. 3G shows a first surface 102 A of the tape body 102 (opposite the second surface 102B in FIG. IB); FIG. 3H shows a close-up view of the proximal portion of the assembly 100 with the suture limbs threaded through; FIG. 31 shows a close-up view of the proximal portion of the second surface 102B of the assembly 100 with the suture limbs buried into themselves; and FIG. 3J shows a close-up view of the distal portion of the second surface 102B of the assembly 100 with the suture limbs buried into themselves). In this embodiment, the two limbs are introduced by securing a single strand or single strand composed of two different limbs spliced together to the middle of the tape (FIG. 3A). The limbs are passed through the side / edges of the tape (FIG. 3B) and secured to the base of the tape by piercing the limb into itself (FIG. 3C).
[0128] Referring to FIGS. 4A-4G, alternative embodiments 100A-100D of the tape and suture construct assembly are shown. FIGS. 4A-4B show a design 100A similar to the design 100 described above, except in this embodiment, only one limb of suture is used. Instead of the two-limb design described above, a loose strand of suture (e.g., 15 mm) can be buried into the suture near the connection points which can obviate the steps of assembling and securing the second suture limb to the first, saving time and materials. FIGS. 4C-4D shows another embodiment 100B that changes the ways to thread sutures through the tape to allow for a connection at the top and two limbs at the bottom (i.e., the suture limbs can be passed through the boarder of the tape and wrapped around the loops of the button assembly). As shown, instead of folding over a portion of the tape 102, a suture loop 200’ is utilized to connect the tape 102 to the button assembly 200. Referring to FIG. 4E, another alternative embodiment 100C is shown. In this embodiment, the direction of sutures within the tape is altered as compared to the above embodiments (i.e., the warp strands positioned widthwise within the tape as opposed to lengthwise) to utilize the warp strand and shuttle the implant above and suture tails below. Referring to FIGS. 4F-4G, another alternative embodiment 100D is shown using round-to-flat suture instead of tape. The embodiment using multiple connected round-to- flat sutures provide transitions to indicate where each piercing should occur within the suture, thereby reducing the amount of suture-to-bone contact. Except as otherwise indicated, theabove identified embodiments are structured and function similarly to the primary embodiment 100 described above.
[0129] FIG. 5 shows the button implant assembly 200 and tape and suture construct assembly 100 whipstitched to a graft 300, as described below.
[0130] Referring to FIGS. 6-7F, an embodiment of a fixation assistant block / clamp assembly 400 to hold a fixation system (e.g., at least the tape and suture construct assembly 100 and button implant assembly 200 described above) is shown. Certain main purposes of the block / clamp assembly 400 include organizing and keeping the components from tangling, and be provided as a sellable product with multiple components. Another main purpose of the block / clamp assembly 400 is to provide a method to secure a quad or soft tissue tendon (i.e., graft 300) in place while it is being attached to an implant of a button assembly 200 as described above. Referring to FIG. 6, an assembled fixation assistant block / clamp 400 is shown with a button implant assembly 200 and suture limbs 104 and 106, as described above. Indentations and channels can be provided within a base 402 of the block / clamp assembly 400 to wind the sutures and button assembly strands around and secure them to the block assembly 400 prior to use.
[0131] Referring to FIG. 7A, a side disassembled view of the block assembly 400 is shown. In this embodiment, the block assembly 400 can have a proximal end 400-2, a distal end 400-1, a base 402, a pivotable arm 404, and an elongated securing portion 406. As shown in FIG. 7A, the elongated securing portion 406 of the base 402 is positioned at the distal end 400-1 and is dimensioned to be accepted by a securing mechanism such as an alligator clip (FIG. 7B). This can provide a means to secure the block assembly 400 to a table or other working surface while a tendon or other graft is being sutured at the proximal end 400-2. In some embodiments (see, e.g., FIG. 7A), the elongated securing portion 406 top and bottom surfaces can be textured to aid in securing it to the securing mechanism. In addition, in some embodiments (see, e.g., FIG. 7A), the elongated securing portion 406 is angled with respect to the base 402 which advantageously provides an elevated surface to make suturing easier. In some embodiments, the elongated securing portion 406, when connected to a securing mechanism, elevates the base 402 of the block 400 approximately 164 degrees with respect to a horizon A, thereby elevating the graft 300 when positioned within the block 400 (angles greater or less than 164 degrees are contemplated, and it should be understood that 164 degrees is given as one of many possible and preferable examples, e.g., less than 180 degrees and greater than 90 degrees). In some embodiments, the elongated securing portion 406 is movable axially with respect to the base 402 to provide a multiple different and customizable angles tochoose from based on the need of the user / medical practitioner. In some embodiments, the elongated securing portion 406 is relatively level with the base 402 and in other embodiments, the elongated securing portion 406 is angled downward with respect to the base 402 (not shown). An assembled side view of the block assembly 400 is shown in FIG. 7B.
[0132] Referring now to FIGS. 7C and 7D, bottom and front side perspective views are shown, respectively. In some embodiments, the arm 404 can have one or more tabs 408 connected to it. The tabs 408 can have a distal end 408-1 and a proximal end 408-2, wherein the proximal end 408-2 is secured to the arm 404 and the distal end 408-1 has a series of indentations or ratchets 410 on the interior portion of the tab 408 that are dimensioned and configured to be accepted by the exterior sides of an extension area 412 of the base 402, explained below. The tabs 408 can be configured to rotate out and away from the base 402 (i.e., radially with respect to the base), while still staying connected to the arm 404 at the proximal end 408-2 to allow the arm 404 to pivot axially with respect to the base 402 and be in the unsecured position (as shown in FIG. 7A). The tabs 408 can serve as a securing mechanism to hold the graft to the surface of the base 402 via the arm 404, as explained further below (i.e., the arm in the secured position as shown in FIGS. 7B- 7D).
[0133] Referring again to FIG. 7D, the base 402 of the block assembly 400 can have an extension area 412 at the proximal end 400-2 of the block assembly 400 that is configured to support the graft and tape thereon. In some embodiments, the arm 404 and the most proximal end of the extension area 412 can have apertures 404-1 and 412-1 forming a channel or cavity therethrough that are aligned with each other and form one elongated channel when the arm 404 is positioned substantially directly over the extension area 412 (i.e., secured position). The alignment of the apertures 404-1 and 412-1 advantageously allows the user to pass the suture around the loop of the button to further reinforce the entire construct of the suture graft to the button before it gets whipstitched down the length of the graft. FIG. 7E shows the tape and suture assembly 100 stored within the block assembly 400, such as when a user would receive the block assembly 400 as a kit.
[0134] After suturing is complete, or the user otherwise wants to release the arm 404 (i.e., move it from the secured position to the unsecured position), the user can pull on the tabs 408 (i.e., pull away from the extension area 412) to remove them from their contacting relation with the extension area 412, allowing the arm to pivot away and release a graft 300 attached thereto, as explained below and as shown in FIG. 7F. As shown, the strands of the button assembly 200 are cleated at the side of the arm 404 and run alongside the length of the arm 400, effectively storing them until the whipstitching process is completed.
[0135] FIG. 8A shows an alternative view of the embodiment shown in FIGS. 7C and 7D. The arm 404 structure has been altered such that the base of the arm 404 sits perpendicularly to the base 402 of the block assembly 400.
[0136] Referring to FIG. 8B, in this alternative embodiment 400- 1 , no needle is present but rather features grooves on a flat surface 414 that the graft can sit on. Similar to above embodiments, ratchets can be featured on the extension area 412 that engages with mechanisms on the interior of the arm 404 that allow the two halves to be secured to one another.
[0137] Referring to FIGS. 8C-8D, another alternative embodiment 400-2 is shown. Rather than having a separate top and bottom component (as shown in the above embodiments e.g., separable arm and extension area / base), a single component where the top and bottom portions (i.e., arm portion and base portion) are connected as one part. Since they are joined together, the top part 404’ can bend or flex downward to engage with the bottom portion 412’ to secure the graft. Similar to above, ratchet mechanisms can be positioned on the interior surface of the top portion (similar to the arm described above) with complementary ratchet mechanisms on the bottom portion such that the two portions come into contacting relation with one another.
[0138] Referring to FIGS. 8E-8H, another alternative embodiment 400-3 is shown. This embodiment 400-4 features a knurl 416 that the graft or tissue can be clamped to and secured within. In this example, the knurl 416 is composed of pointed triangular shapes spaced apart that grasp the tissue and do not puncture the graft. While triangular shapes are shown and described, it should be understood that other shapes or geometries can be used to secure the graft. The arm component 404” and extension area 412” mate together to trap the graft, with the knurl on both portions. In addition, the arm 404 is still pivotable with respect to the base, but instead of having tabs on either side to secure it to the base, there is a tab 408’ that is connected to and extends perpendicularly with respect to the arm 404 with a series of pointed ratchet features that are configured to secure into an aperture 418 in the extension area 412”. In some embodiments, the knurl 416 is only positioned on one of the extended portion or arm portion.
[0139] Except as otherwise indicated, the above identified embodiments are structured and function similarly to the primary embodiment 400 described above.
[0140] Referring to FIGS. 9-19D, a method of forming a suture loop for stitching (e.g., whipstitching) using the block assembly 400 is shown. While a method including the use of the block assembly 400 is shown and described, it should be understood that it can be performed without the block assembly 400 by passing the suture limbs 104 and 106 around atissue graft 300 so that the first limb 104 is on one side of the graft 300 and the second limb 106 is on the other side of the graft 300. The first limb 104 can be threaded into the opening of the eyelet 110 that is connected to the needle 108 and the needle can be pierced through the graft 300 (with both the first limb 104, second limb 106, and eyelet 110 following therethrough). The needle 108, suture limbs 104 / 106, and eyelet 110 will all be positioned underneath the graft 300, and then the first limb 104 can be removed from the eyelet 110. Next, the first limb (and thus needle 108 and eyelet 110) can be brought around one side of the graft 300 while the second limb 106 is brought around the opposite side of the graft 300, such that both limbs 106 and 106 are now positioned above the first surface 102A of the graft. This can be repeated until the limbs 104 and 106 have been threaded through the entire length of the tape 102. The suturing method described herein is similar to that described in WO 2024211557 (which is incorporated by reference herein), with a difference being that the eyelet 110 is a separate structure from the second suture limb 106 (but still connected to the needle 108).
[0141] To whipstitch or otherwise secure a graft to a button implant assembly using the block assembly 400, a user can first attach the block assembly 400 to a clamp (e.g., alligator clamp) on a surface and ensure it is secure (FIG. 9). Next, the arm 404 can be pulled away from the base 402 / extension area 412 (i.e., unsecured position) (FIG. 10A) so that the marked end / area of the graft 300 with the thinnest width can be positioned on the teeth or knurl 416 of the extension area and secured thereto (FIG. 10B). The arm 404 can be lowered by applying pressure on its top surface to engage the ratchet and secure the graft 300 (FIG. 10C). The second end of the graft (i.e., the end not connected to the block assembly 400) can be secured by an alligator clamp or other similar mechanism and adjusted so that the graft 300 lays flat (FIGS. 11A-11B).
[0142] Referring to FIGS. 12A-12D, to begin the whipstitch, the needle 108 can be pierced in the center of the graft (without piercing the tape in some embodiments to ensure the tape lays flat) adjacent to the second end 102-2 of the tape 102 until it is just passed through the graft 300 (FIG. 12A). The first suture limb 104 can then be passed through the eyelet 110 and then the needle 108 can be passed all the way through the graft 300 (bringing the first limb 104, second limb 106, and eyelet 110 through first surface 300A as well, as explained above). The suture limbs 104 and 106 should be tensioned to ensure the tape 102 lays flat. Once the first limb 104 is separated from the second limb 106 underneath (300B, opposite 300A) the graft 300 such that the first limb 104 is on one side (e.g., adjacent to 102-3) and the second limb 106 is on the other (e.g., adjacent to 102-4) (FIG. 12D), the limbs 104 and 106 can be brought around to the first surface 102 A of the tape 102 on their respective sides so that bothsuture limbs 104 and 106 are now positioned above the first surface 102A of the tape 102 (and therefore first surface of the graft 300A). To continue with a whipstitch, the user can pierce needle 108 through the tape 102 on the second side 102-4 closest to the second end 102-2 of the tape 102 until it just pierces the tape 102 (FIG. 13 A). The first suture limb 104 can be positioned through the eyelet 110 and the needle 108 can fully pass through the graft 300, pulling on the suture limbs 104 and 106 underneath (i.e., under the second surface of the graft 300B) to tension. While under the second surface 300B of the graft 300, the suture limbs 104 and 106 can be separated so that the first limb 104 is on one side and the second limb 106 is on the other, as explained above (FIG. 13B). The needle 108 can then pierce the tape 102 adjacent to the first end 102-1 until it just goes through the graft 300 (FIG. 14), thread the first suture limb 104 through the eyelet 110, and pass the remaining portion of the needle 108 through the graft 300, pulling the limbs 104 and 106 to fully cinch them to the graft 300. To complete the whipstitch, a user can, while still being positioned underneath the graft 300 (i.e., second surface 300B), pass the first suture limb 104 through the eyelet 110 (FIG. 15A) and then pass the needle 108 (and thus the two suture limbs and eyelet) through the aligned apertures 404-1 and 412-1 of the arm 404 and extension area 412 (FIG. 15B). The needle 108 can pierce the center ofthe graft 300 above the previous stitch (i.e., substantially adjacent to the first end 102-1 ofthe tape 102) (FIG. 15C), ensuring the first suture limb 104 is positioned through the eyelet 110, and pass the needle 108 through the graft 300, separating the suture limbs 104 and 106 underneath (FIG. 15D). The suture limbs can be brought around to be positioned above the first surface of the graft 300 A and a user can pierce the needle 108 into the first side ofthe tape 102-3 between the primary stitch 112 and secondary stitch 114 (or between two stitches that allow for the needle to pierce the tape at its center) (FIG. 16A), thread the first suture limb 104 through the eyelet 110, pass the needle 108 through the graft 300, apply tension, and separate the limbs 104 and 106 under the second surface 300B of the graft 300 (FIG. 16B). Finally, a user can bring the limbs 104 and 106 to be positioned above the first surface of the tape 102A (and graft), pierce the tape (and graft) into the center of the first side 102-3 toward the second end 102-2 ofthe tape 102 below the furthest whipstitch (i.e., the whipstitch that is positioned most distally on the tape) (FIG. 17) and without piercing the first suture made in the preliminary securing step, thread the first suture limb 104 through the eyelet 110, pass the needle through the graft 300, apply tension, and remove the limbs 104 and 106 so that they are on their respective sides. One or more knots can be tied in the suture limbs 104 and 106 to secure the stitches to the graft (FIGS. 18A-18C) and the first suture limb 104 can be cut (FIG. 18D). In a preferred embodiment, approximately six alternating half-hitch knots are used, but other numbers andother securing knots are contemplated. In a preferred embodiment, the first suture limb is cut approximately 0.25 inches from the knot. To finish securing the tape 102 to the graft 300, the needle 108 can be pierced into the graft 300 just below the tape 102 and pulled just until the knot or group of knots pass through the graft 300, ideally securing them within the graft 300 (FIG. 19A). The excess second limb 106 can be cut underneath the second surface of the graft 300B (FIG. 19B). The graft 300 can then be removed from the block assembly 400 by pulling up (as shown) on the arm 404, removing the alligator clamp, and unraveling the button assembly 200 from the block assembly 400 (FIGS. 19C-19D).
[0143] It should be understood that fewer or additional whipstitches or other suturing means can be used to secure a graft to the tape depending on its length and strength desired. In some examples, the set of whipstitches can form a crisscross or X-pattem over a first set of whipstitches, effectively interlocking the two sets (as should be understood by a person of ordinary skill in the art in conjunction with review of this disclosure). While the whipstitch suture pattern is discussed above, any suture pattern or technique can be employed (as should be understood by a person of ordinary skill in the art in conjunction with review of this disclosure).
[0144] In accordance with another embodiment, a kit can be provided which can include, but is not limited to, any possible combination of the following: a tape and suture assembly (preassembled (i.e., the limbs come pre-assembled into the tape) or unassembled), a graft, a button implant assembly, and a block assembly.
[0145] FIGS. 20A-26C show alternative embodiments with respect to the tape and suture construct. Unless otherwise indicated, the whipstitching or suturing method is the same as what is described above.
[0146] Referring to FIGS. 20A-20D, this embodiment features a round-flat suture construct which could be applied to any of the trailing needle loop embodiments. Each suture limb 604 and 606 can have round-flat suture along its length and a needle 608 at each end. The needle 608 of the first suture limb 604 can preferably pass through the flat suture of the second suture limb 606 (either once FIG. 20C or twice FIG. 20B), and once secured within, the second limb 606 can be cut, as shown in FIG 20C. Then the whipstitching can be performed, looping the excess suture from the first limb 604 up and around the graft 300 (FIG. 20D).
[0147] Referring to FIG. 21A, this embodiment similarly has round-flat suture on the first limb 604 and the second limb 606. The needle 608 of the first limb 604 can pass through a pinched portion of the flat portion of the suture of the second limb 606, and then the first limb604 can be cut at a position before the flat portion of the suture (excluding the flat suture portion on first limb 604), as shown in FIG. 2 IB.
[0148] Referring to FIG. 21B, this embodiment is similar to the one above in 21A, except the flat portion of the first suture limb 604 does not get cut off - only the needle 608 gets removed prior to whipstitching the tape 102 to the graft 300.
[0149] Referring to FIGS. 22A-22B, in this embodiment, two tape constructs are shown (first tape 604A and second tape 606A) - each having one suture limb with a needle attached at the end (first suture limb 604 and second suture limb 606) and a separate eyelet (604B and 606B), similar to the embodiment described above. The tape constructs 604A and 606A can be positioned over the graft 300 (the first 604A on the first surface of the graft, and the second 606A on the second surface of the graft) and then to whipstitch, the first suture limb 604 can be positioned into the eyelet 606B of the second suture limb 606 and then cut as shown by the scissors.
[0150] Referring to FIG. 22C, in this embodiment, both suture limbs 604 and 606 include a separate eyelet 604B and 606B connected to the needles 608 (similar to above). The first suture limb 604 passes through the eyelet 606B of the second suture limb 606, and the second suture limb 606 passes through the eyelet 604B of the first suture limb 604.
[0151] Referring to FIGS. 23A-23C, in this embodiment, a looped portion 604’ is made with the suture limbs 604 and 606 onto the surface of the tape body 102, as shown. The graft 300 can be positioned through the looped portion 604’, and the tape 102 can be folded over the graft 303 as shown. Before the tape 102 is secured to the graft 300, a button assembly 200 looped portion 202 can be included such that the tape 102 folds over the button assembly loop portion 202 and the graft 300 (300A), then secured to the second surface of the graft 300B. Whipstitching needle configuration(s) can be formed by limbs 604 and 606 and whipstitching can be performed, as discussed above.
[0152] Referring to FIG. 23D, in this embodiment, a flat-round suture construct 102’ is used but functions similarly to what is described above in FIGS. 23A-23C, but has an extra needle on the right side.
[0153] Referring to FIGS. 24A-24E, in this embodiment, a proximal looped portion 604’ of the suture limbs 604 and 606 is wrapped around the graft 300 and the suture limbs 604 and 606 are pulled to constrict the loop 604’ (securing it to the graft 300) (FIGS. 24A-24B). The needle 608 at the end of the second suture limb 606 is passed through the graft 300 to create a distal loop 604” (e.g., passed two times) (FIG. 24C). The suture limbs 604 and 606 are pulled to constrict the distal loop 604”, securing it to the graft 300 at the distal end as shown(FIG. 24D). The first suture limb 604 is passed through the eyelet 610 (similar to above) at the back of the needle 608 to create a larger loop to perform the whipstitching (FIGS. 24D and 24E).
[0154] Referring to FIGS. 25A and 25B, in this embodiment, the needle 608 has a looped portion 608’ which can be folded over and secured (similar to a luggage tag) to the suture loop 604 that extends from the tape 102 which can then be secured to the graft 300.
[0155] Referring to FIGS. 26A-26C, in this embodiment, two suture limbs 604 and 606 are attached to a needle 608 with loops at each end 604’ and 606’ (FIG. 26A). The loops 604’ and 606’ can be positioned over the graft 300 as shown (FIG. 26B) and the remaining portion of the suture limbs 604 and 606 can be pulled to constrict the loops 604’ and 606’ over the graft 300 (FIG. 26C).
[0156] Referring to FIGS. 27A-27G, a suture and needle construct 700 having a collapsible loop 702 at one end terminating in a cinching end 704, an eyesplice section 706, and a larger loop 708 with a needle 710 crimped at one end is shown. The construct 700 is primarily used for whipstitching a quad tendon, but can be used to stitch other types of soft tissue grafts 300 as well, as applied above.
[0157] In this embodiment, the collapsible loop 702 is passed over one end of a soft tissue graft 300 (FIG. 27B) then the cinching end 704 is pulled securing the loop 702 in position over the graft (FIG. 27C). The eyesplice section 706 is pulled and positioned coaxially and centered across the width of the graft 300 as shown and the needle 710 is then pierced through the graft 300 thereby maintaining its position and orientation (FIG. 27D). The large loop 708 is then passed over the graft 300 and the needle 710 is pierced through the eyesplice 706 just distal to the previous pierce (FIG. 27E) and the loop 708 is pulled tight creating a whipstitch. This locks the collapsible loop 702 and creates a “ripstop”. The large loop 708 is again passed over the graft 300 and another pierce just distal to the last is made in the same fashion (FIG. 27F). This process is repeated until the desired amount of stitches are created (FIG. 27G).
[0158] While various embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the function and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the teachingsis / are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the scope of the present disclosure. All embodiments and features thereof are intended to be combinable in any way mechanically possible.
[0159] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as, “has” and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises”, “has”, “includes” or “contains” one or more steps or elements. Likewise, a step of method or an element of a device that “comprises”, “has”, “includes” or “contains” one or more features possesses those one or more features but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way but may also be configured in ways that are not listed.
[0160] The corresponding structures, materials, acts and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The descriptions of embodiments of the disclosure have been presented for purposes of illustration and description but is not intended to be exhaustive or limited to embodiments in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the disclosed embodiments. The embodiments were chosen and described in order to best explain the principles of one or more aspects of the claimed or to be claimed invention and the practical application, and to enable others of ordinary skill in the art to understand one or more aspectsof the present disclosure for various embodiments with various modifications as are suited to the particular use contemplated.
Claims
CLAIMSWhat is claimed is:
1. A tape and suture construct assembly, comprising: a tape body portion having a first end and a second end, a first side and a second side; a first suture strand having a first end and a second end, wherein the first end of the first suture strand is attached to and extends from the second end of the tape body adjacent to the first side of the tape body; a second suture strand having a first end and a second end, wherein the first end of the second suture strand is attached to and extends from the second end of the tape body adjacent to the second side of the tape body; and wherein the second end of the second suture strand is connected to a first end of a needle, and a separate looped end extending from the first end of the needle adjacent to the second end of the second suture.
2. The tape and suture construct assembly of claim 1, wherein the looped end is formed of a material different from the second suture strand.
3. The tape and suture construct assembly of claim 2, wherein the looped end is formed from nitinol wire.
4. The tape and suture construct assembly of claim 3, wherein a portion of each of the looped end and the second suture is positioned and fixed within the needle.
5. The tape and suture construct assembly of claim 1 , wherein a portion of the first suture strand and a portion of the second suture strand are spliced together to form a single strand.
6. The tape and suture construct assembly of claim 1, wherein the first end of the tape body portion is folded over and is configured to connect to a button assembly.
7. A surgical system, comprising:a tape and suture construct assembly, comprising: a tape body portion having a first end and a second end, a first side and a second side; a first suture strand having a first end and a second end, wherein the first end of the first suture strand is attached to and extends from the second end of the tape body adj cent to the first side of the tape body; a second suture strand having a first end and a second end, wherein the first end of the second suture strand is attached to and extends from the second end of the tape body adjacent to the second side of the tape body; and wherein the second end of the second suture strand is connected to a first end of a needle, and a separate looped end extending from the first end of the needle adjacent to the second end of the second suture; and a button implant assembly, comprising: a button; and a first suture loop connected to the button via a first portion and to the first end of the tape body portion via a second portion.
8. The surgical system of claim 7, wherein the looped end is formed of a material different from the second suture strand.
9. The surgical system of claim 8, wherein the looped end is formed from nitinol wire.
10. The surgical system of claim 9, wherein a portion of each of the looped end and the second suture is positioned and fixed within the needle.
11. The surgical system of claim 7, wherein the first end of the tape body portion is folded over the second portion of the first suture loop.
12. The surgical system of claim 12, wherein a portion of the first suture strand and a portion of the second suture strand are spliced together to form a single strand.
13. A method of attaching a tape and suture construct assembly to a tissue graft, the method comprising the steps of: providing a tape and suture construct assembly comprising:a tape body portion having a first end and a second end, a first side and a second side; a first suture strand having a first end and a second end, wherein the first end of the first strand is attached to and extends from the second end of the tape body adjacent to the first side of the tape body; a second suture strand having a first end and a second end, wherein the first end of the second suture strand is attached to and extends from the second end of the tape body adjacent to the second side of the tape body; and wherein the second strand comprises a needle attached to the second end of the second strand and an opening positioned between the needle and the first end of the second suture; positioning the tape body on a first surface of the tissue graft; passing the first suture strand through the opening; and passing the needle, the first suture strand and the second suture strand through the tape body and the tissue graft.
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