Implant delivery system

Abstract

The present disclosure relates generally to an implant delivery system, and more particular to a bioinductive implant delivery system and method.

Description

TITLEIMPLANT DELIVERY SYSTEMBACKGROUND1. FIELD OF THE DISCLOSURE

[0001] The present disclosure relates generally to an implant delivery system, and more particular to a bioinductive and biocomposite implant delivery system and method.2. DESCRIPTION OF THE RELATED ART

[0002] Conventional surgical implants and related delivery systems are known.

[0003] Description of the Related Art Section Disclaimer: To the extent that specific patents / publications / products are discussed above in this Background Section or elsewhere in this Application, 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 Background 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 inventors of the present disclosure recognize that there are problems associated with certain conventional surgical implants (such as bioinductive / biocomposite implants) and related delivery systems, and that there is a need for an improved implant and related delivery systems and methods. For example, certain conventional surgical implants are provided alone just as an implant. During a surgical procedure, surgeons are currently required to manually pass suture through the implant and use several various instruments to introduceand control the implant in the subacromial space. Due to certain constructions and strength of the certain implants, existing suture passers cannot reliably pass suture therethrough (the suture can get stuck and can tangle) and can damage the implants. Additionally, due to the manual nature of suture passing, the user may place the suture too close to the edge of the implant and result in compromised strength of a final augmentation construct (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). Medial sutures are usually passed through the implant away from the surgical site; however, lateral sutures are often passed with the implant at the surgical site to avoid tangling sutures while introducing the implant to the subacromial space. This has all the difficulties described above and compounds them by performing the suture passing arthroscopically. Accordingly, there is a need in the art for an improved bioinductive and biocomposite implant delivery system.

[0005] It is therefore a principal object and advantage of the present disclosure to provide a bioinductive / biocomposite implant and an improved delivery system and method for the same that eliminate one or more of the problems / issues / deficiencies associated with conventional devices / systems. The devices / assemblies / systems of an embodiment can be used during an arthroscopic rotator cufiZrepair and similar surgical procedures where bioinductive / biocomposite implants are or can be used (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). In particular, the present disclosure is directed to embodiments of inventive devices / assemblies / systems configured to deliver bioinductive / biocomposite implants that facilitate implantation during the aforementioned surgical procedures. A non-limiting goal associated with the inventive device / assembly / system embodiments is to allow the user to easily load sutures at a medial edge of the implant in pre-determined locations, ensuring strength is maintained. A lateral edge of the implant can be pre-stitched with sutures to avoid the issues of manually passing such sutures. The implant pre-stitched with lateral sutures can be provided to the userreleasably attached to a delivery system or inserter. This allows the user to introduce and control the implant in the subacromial space. The delivery system can also keep the lateral sutures managed, preventing tangles, until the delivery system is removed (During introduction, the pre-stitched lateral stitches can be inside of the delivery system shaft to prevent tangling of the same with the medial stitches passed with the threaders.).

[0006] As described and illustrated herein and in accordance with an embodiment, an implant with an implant inserter / delivery system can include an implant pre-stitched with suture (e.g., HI-FI suture) pre-loaded and attached to a delivery / inserter system / assembly. The delivery / inserter system / assembly can include a threader assembly to facilitate the passing of sutures through the implant, and an inserter assembly to facilitate placement of the implant into a subacromial space of a patient. The implant can be provided in multiple sizes including, but not limited to, 23x25 mm and 35x25 mm. While the length and width can differ in these embodiments (but does not have to in other embodiments), the thickness can be the same / consistent in certain embodiments (which is preferred) but not in others.

[0007] These and other aspects of the embodiments of this disclosure will be apparent from and elucidated with reference to the embodiment(s) described hereinafter.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0008] Embodiments of 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. 1 is a side view schematic representation of an implant delivery systemaccording to an embodiment.

[0010] FIG. 2 is a distal end perspective view schematic representation of an implant delivery system according to an embodiment.

[0011] FIG. 3 is a proximal end view schematic representation of an implant delivery system according to an embodiment.

[0012] FIG. 4 is a bottom view schematic representation of an implant delivery system according to an embodiment.

[0013] FIG. 5 is a bottom perspective view schematic representation of an implant delivery system according to an embodiment.

[0014] FIG. 6A is a close-up bottom view schematic representation of the distal end of an implant delivery system according to an embodiment.

[0015] FIG. 6B is a bottom view of the distal end of an alternative embodiment of the implant delivery system.

[0016] FIG. 7 is another close-up bottom view schematic representation of the distal end of an implant delivery system according to an embodiment.

[0017] FIG. 8 is a close-up top view schematic representation of the distal end of an implant delivery system according to an embodiment.

[0018] FIG. 9 is a close-up perspective view schematic representation of the distal end of an implant delivery system according to an embodiment.

[0019] FIG. 10 is another close-up bottom view schematic representation of the distal end of an implant delivery system according to an embodiment.

[0020] FIG. 11 is another close-up top view schematic representation of the distal end of an implant delivery system according to an embodiment.

[0021] FIG. 12 is another close-up bottom perspective view schematic representation of the distal end of an implant delivery system according to an embodiment.

[0022] FIG. 13 is a close-up botom perspective view schematic representation of an implant delivery system according to an embodiment.

[0023] FIG. 14 is another close-up bottom perspective view schematic representation of an implant delivery system according to an embodiment.

[0024] FIG. 15 is another close-up bottom perspective view schematic representation of an implant delivery system according to an embodiment.

[0025] FIG. 16 is another close-up top view schematic representation of the distal end of an implant delivery system according to an embodiment.

[0026] FIG. 17 is a perspective view schematic representation of an implant delivery system with the top cover removed for illustrative purposes, according to an embodiment.

[0027] FIG. 18 is a top view schematic representation of the second threader housing of an implant delivery system according to an embodiment.

[0028] FIG. 19 is a botom view schematic representation of the second threader housing of an implant delivery system according to an embodiment.

[0029] FIG. 20 is a close-up perspective view schematic representation of the second threader housing of an implant delivery system according to an embodiment.

[0030] FIG. 21 is a close-up bottom view schematic representation of the proximal end of the second threader housing of an implant delivery system according to an embodiment.

[0031] FIG. 22 is a close-up side view schematic representation of the proximal end of the second threader housing of an implant delivery system according to an embodiment.

[0032] FIG. 23 is a perspective view schematic representation of the proximal end of an implant delivery system according to an embodiment.

[0033] FIG. 24 is a close-up botom view schematic representation of the proximal end of an implant delivery system according to an embodiment.

[0034] FIG. 25 is another close-up botom view schematic representation of an implantdelivery system according to an embodiment.

[0035] FIG. 26A is a perspective view schematic representation of an implant delivery system moving toward a ready to be deployed position according to an embodiment.

[0036] FIG. 26B is a close-up perspective bottom view schematic representation of the proximal end of an implant delivery system according to an embodiment.

[0037] FIG. 26C is another close-up perspective bottom view schematic representation of the proximal end of an implant delivery system according to an embodiment.

[0038] FIG. 26D is another close-up perspective bottom view schematic representation of the proximal end of an implant delivery system according to an embodiment.

[0039] FIG. 27 is another bottom view schematic representation of an implant delivery system according to an embodiment.

[0040] FIG. 28 is a perspective disassembled side view schematic representation of an implant delivery system according to an embodiment.

[0041] FIG. 29 is another perspective disassembled view schematic representation of an implant delivery system according to an embodiment.

[0042] FIG. 30 is an exploded view schematic representation of an implant delivery system according to an embodiment.

[0043] FIG. 31 shows a step in the process of using an implant delivery system according to an embodiment.

[0044] FIG. 32 shows a step in the process of using an implant delivery system according to an embodiment.

[0045] FIG. 33 shows a step in the process of using an implant delivery system according to an embodiment.

[0046] FIG. 34 shows a step in the process of using an implant delivery system according to an embodiment.

[0047] FIG. 35 shows a step in the process of using an implant delivery system according to an embodiment.

[0048] FIG. 36 shows a step in the process of using an implant delivery system according to an embodiment.

[0049] FIG. 37 shows a step in the process of using an implant delivery system according to an embodiment.

[0050] FIG. 38 shows a step in the process of using an implant delivery system according to an embodiment.

[0051] FIG. 39 shows a step in the process of using an implant delivery system according to an embodiment.

[0052] FIG. 40 shows a step in the process of using an implant delivery system according to an embodiment.

[0053] FIG. 41 shows a step in the process of using an implant delivery system according to an embodiment.

[0054] FIG. 42 shows a step in the process of using an implant delivery system according to an embodiment.

[0055] FIG. 43 shows a step in the process of using an implant delivery system according to an embodiment.

[0056] FIG. 44 shows a step in the process of using an implant delivery system according to an embodiment.

[0057] FIG. 45 shows a step in the process of using an implant delivery system according to an embodiment.

[0058] FIG. 46 shows a step in the process of using an implant delivery system according to an embodiment.

[0059] FIG. 47A shows a step in the process of using an implant delivery system according to an embodiment.

[0060] FIG. 47B shows a completed rotator cuff augmentation without medial knots according to an embodiment.

[0061] FIG. 48A is a side and top view schematic representation of an implant delivery system according to an embodiment.

[0062] FIG. 48B shows a step in the process of using an implant delivery system according to an embodiment.

[0063] FIG. 49 is a side and top view schematic representation of an implant delivery system with the housing removed for illustrative purposes according to an embodiment.

[0064] FIG. 50A is a close-up view schematic representation of the distal end of animplant delivery system according to an alternative embodiment.

[0065] FIG. 50B is another close-up view schematic representation of the distal end of an implant delivery system according to an alternative embodiment.

[0066] FIG. 51 is a bottom view schematic representation of an implant delivery system according to an alternative embodiment.

[0067] FIG. 52A is a top perspective view schematic representation of an implant delivery system according to an alternative embodiment.

[0068] FIG. 52B is another top perspective view schematic representation of an implant delivery system according to an alternative embodiment.

[0069] FIG. 53 A is a top perspective view schematic representation of an implant delivery system according to an alternative embodiment.

[0070] FIG. 53B is a top deconstructed view schematic representation of an implant delivery system according to an alternative embodiment.

[0071] FIG. 53C is another top view schematic representation of an implant delivery system according to an alternative embodiment.

[0072] FIG. 53D is another top view schematic representation of an implant delivery system according to an alternative embodiment.

[0073] FIG. 53E is a perspective view schematic representation of an implant delivery system according to an alternative embodiment.

[0074] FIG. 53F is another top view schematic representation of an implant delivery system according to an alternative embodiment.

[0075] FIG. 53G is another top view schematic representation of an implant delivery system according to an alternative embodiment.

[0076] FIG. 53H is a close-up perspective view schematic representation of the distal end of an implant delivery system according to an alternative embodiment.

[0077] FIG. 531 is a close-up top view schematic representation of the proximal end of an implant delivery system according to an alternative embodiment.

[0078] FIG. 53J is a top perspective view schematic representation of an implant delivery system according to an alternative embodiment.

[0079] FIG. 53K is a bottom perspective view schematic representation of an implant delivery system according to an alternative embodiment.

[0080] FIG. 54A is a bottom perspective view schematic representation of an implant delivery system according to an alternative embodiment.

[0081] FIG. 54B is a side view schematic representation of an implant delivery system according to an alternative embodiment.

[0082] FIG. 55 is a side view schematic representation of an implant delivery system according to an alternative embodiment.

[0083] FIG. 56 is a bottom view of the distal end of an alternative embodiment of the implant delivery system.

[0084] FIG. 57 is a bottom view of the distal end of an alternative embodiment of the implant delivery system.

[0085] FIG. 58 is a bottom view of the distal end of an alternative embodiment of the implant delivery system.

[0086] FIG. 59 is a bottom perspective view of the distal end of an alternative embodiment of the implant delivery system.

[0087] FIG. 60 is a top perspective view of the distal end of an alternative embodiment of the implant delivery system.

[0088] FIG. 61 is a top perspective view of the distal end of an alternative embodiment of the implant delivery system.

[0089] FIG. 62 is a bottom perspective view of the distal end of an alternative embodiment of the implant delivery system.DETAILED DESCRIPTION

[0090] Aspects of the present embodiments and certain features, advantages, inventive features, 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 omitted so as not to unnecessarily obscure the inventive features of the embodiments in detail. It should be understood, however, that the detailed description and the specific non-limitingexamples, while indicating aspects of the inventive features of the embodiments, are given by way of illustration only, and are not byway 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.

[0091] While embodiments of the 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 the inventive features of the embodiments 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 are 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 (and / or as should be appreciated by a person of ordinary skill in the art with reference to this disclosure).

[0092] This disclosure is related to bioinductive or reinforced bioinductive / biocomposite implants used for soft tissue augmentation, and the delivery of the same to a surgical site by a medical practitioner. In one or more embodiments, the bioinductive or reinforced bioinductive implant includes Applicant’s “BioBrace” implant (BioBrace®, U.S. trademark reg. no. 6569750; goods - bioresorbable tissue-engineered scaffold implant that facilitates the regeneration of new tissue, namely, a tissue-engineered scaffold implant made primarily of collagen, being a biological material, and polymer implanted internally by a surgeon in a patient's body that is fully bioresorbable and remodels into functional tissue that enables the patient's body to heal itself without the pain and risks associated with traditionalsurgical implants; owned by Applicant; and, for example, product nos. BB23X25 & BB35X25). BioBrace or implant, as used herein can refer to the aforementioned goods, and / or to a bioinductive or reinforced bioinductive implant, which is durable enough to support suturing, hard anchor, and cannula passing. Biobrace or implant can feature a highly porous type 1 collagen matrix (e.g., 20pm average pore size) reinforced with bioresorbable PLLA microfilaments (e.g., 15pm diameter). Biobrace or implant can provide supplemental strength through load sharing, can include a biologic scaffold that facilitates and optimizes healing, and can provide supplemental strength for approximately 2 years before naturally resorbing. Unlike traditional implant materials that are either synthetic or biologic, BioBrace® or implant can be a biocomposite of both. Biobrace or implant can also include the composite scaffold products and methods illustrated and described in US 20210161645.

[0093] In accordance with an embodiment, an implant can be an absorbable implant provided terminally sterile by Ethylene Oxide sterilization. As such, the implant can have a sterile barrier that is also a moisture barrier. The overall packaging system can include, for example, an insert tray located inside of the sterile barrier, and this component can retain the product and facilitate aseptic delivery to the sterile field; a foil pouch - the device’s sterile barrier, and can include a Tyvek® header that is removed after sterilization and sealing of the foil pouch (the insert tray and device can be contained within the foil pouch); and a SBS carton - as an outer carton that the foil pouch and contents can be contained within.

[0094] As discussed herein, example primary functions of a delivery system of an embodiment include one or more of the following: providing the user an implant pre-stitched with single-tail mattress stitches at a lateral edge; allowing the user to load sutures though the implant at pre-defined locations (e.g., 2, 4, 6, and 8 locations) on the medial edge; and allowing the user to insert the implant through a cannula and into the subacromial space of a patient.

[0095] Referring now to the figures, wherein like reference numerals refer to like partsthroughout, an embodiment of the implant delivery system 10 is shown and described including fully assembled, particular components, magnified, and exploded views of the same.

[0096] FIGS. 1-3 show fully assembled views of an implant delivery system 10 according to an embodiment of the present disclosure. Turning to FIG. 1, a perspective side view of a fully assembled implant delivery system 10 is shown according to an embodiment of the present disclosure. As shown, implant delivery system 10 has a distal end 10-1 and a proximal end 10-2, atop cover 20, a first / top threader housing 30, and a second / bottom threader housing 40. A handle 50 can be positioned at and connected to the proximal end 10-2 of the implant delivery system 10. As discussed further below, top cover 20 and first / top threader housing 30 are movably connected to second / bottom threader housing 40. A separate top cover 20 is not required, which can be part of a unitary construction of the first / top threader housing 30. However, when a separate top cover 20 is present in a particular embodiment, the top cover 20 can be snap fit, friction fit, adhesive fit (or other connection means as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure) to the first / top threader housing 30, and the first / top threader housing 30 can be slidably connected (via flange / rail and rail / groove) to the second / bottom threader housing 40 and to the handle 50.

[0097] Turning to FIGS. 2-3, a top distal view and top proximal view of the implant delivery system 10 are shown, respectively.

[0098] Referring to FIGS. 4-5, a bottom view and bottom perspective view of the implant delivery system 10 are shown, respectively.

[0099] Referring now to FIGS. 6A and 7, a bottom view and bottom view (with the implant 60 removed) of the distal end 10-1 of the implant delivery are shown, respectively. Top threader holes 40-2 and middle threader holes 40-4 can be formed through the second threader housing 40 to assist with capturing and pulling the suture through an implant 60 via threaders 60-4 at the medial suture locations 60-8 and through bottom threader holes 40-6, asexplained further below. In this example, the implant 60 can be a PLAA-Collagen scaffold that can be implanted into a patient, as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure. Also in this example, the threaders 60-4 can have a nitinol eyelet and stainless-steel shaft sleeve. Once passed through the holes 40-4, the nitinol wire can pull the suture from the holes in the threader back plate through the implant and to the top side of the second threader housing 40.

[0100] Turning to FIG. 6B, a bottom view of the distal end 10-1 of an alternative embodiment of the implant delivery system is shown. In particular, all other components being the same or similar, this embodiment is a six-threader 60-4 version for a 35x35 mm implant version of the implant (although other sizes of the implant can be used, as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

[0101] The implant 60 can also have one or more retention stitches 60-6 and single tail mattress stitches 60-2 (and corresponding openings formed therethrough, not shown). The retention suture and lateral sutures (collectively threads 80) form the stitches 60-6 and 60-2 (or other similar suture-like material) that can connect the implant 60 to an elongated cannulated inserter tube / shaft 70 and pass through a first opening 70-2 in the cannulated inserter tube 70 and through to the proximal end of the device, as explained below (they can each also pass through a separate hole on the sides of the tube, as they are shown extending to in FIG. 6B, for example). In this example, the single-tail mattress stitches can be pre-loaded stitches that allow a user to fix the lateral edge of the implant 60 and are formed of lateral sutures. The retention stitch can be a length of high-strength suture that is used to hold the implant onto the foot 70- 6 of the cannulated inserter tube 70, but can be removed and not permanently implanted within a patient. In some embodiments, the retention stitch 60-6 can pass through a second opening 70-4 in the cannulated inserter tube 70 to further secure the implant 60 to the cannulated inserter tube 70 and allow for the implant 60 to move with the cannulated inserter tube 70 as the implantdelivery system 10 moves from an undeployed position to a deployed position, as explained further below. The portion of the retention stitch 60-6 can then pass through the first opening 70-2 of the cannulated inserter tube 70 and through to the proximal end of the device.

[0102] Referring now to FIGS. 8-9, a bottom close-up view and bottom perspective view of the distal end 10-2 of the of the implant delivery system 10 are shown, respectively. Referring to FIG. 8 specifically, a portion of the cannulated inserter tube 70 and first threader housing 30 are removed for illustration purposes. The surface 40-8 of the second threader housing 40 can provide a surface structure and attachment / foundation interface against which the implant 60 can stabilize while medial sutures (not shown) are being threaded therethrough, as explained below.

[0103] Referring to FIGS. 10-12, close-up views of the distal end 10-2 of the implant delivery system 10 are shown. FIG. 10 shows a bottom view of the first threader housing 30 with the cannulated inserter tube 70 positioned thereon and the threaders 60-4 extending therefrom (with the second threader housing 40 removed). FIG. 11 shows the same bottom view as FIG. 10 with the first threader housing 30 removed and the top cover 20 positioned underneath. FIG. 12 shows a side view of the view shown in FIG. 11.

[0104] Referring now to FIG. 13, a bottom close-up view of the second threader housing 40, a portion of which being positioned within the first threader housing 30, is shown. As can be seen, the second threader housing 40 can further comprise a channel 40-12 through which the cannulated inserter tube 70 can be positioned. In this embodiment, the first threader housing 30 can move along the elongated ridges 40-14 of the second threader housing 40 via an elongated rail or ridge 30-2 toward the proximal end 10-2, as explained further below, while the cannulated inserter tube 70 and handle 50 can remain stationary with respect to both housings (or move depending on one’s perspective). The second threader housing 40 can include one or more ridges 40-10 that contact the first threader housing 30 as shown to act asa “stop” and prevent the first threader housing 30 from moving too far in the distal direction 10-2 with respect to the second threader housing 40 (and preventing the first threader housing 30 and the top cover 20 from affecting the proper functionality of the threaders 60-4, as explained below).

[0105] Referring to FIG. 14, a bottom close-up view of the first threader housing 30 is shown with the second threader housing 40 and cannulated inserter tube 70 removed for illustration purposes. As shown, threads 80 (i.e., retention stitches 60-6 and single tail mattress stitches 60-2 as discussed above) can be positioned within the cannulated inserter tube (not shown) and extend from the implant (not shown) through the end of the device to the handle (not shown), as discussed further below.

[0106] Referring now to FIG. 15, a bottom close-up view of the first threader housing 30 is shown. The first threader housing 30 can include one or more ridges 30-2 that sit on top of and glide along the ridges of (and move with respect to) the second threader housing (see, e.g., FIG. 13) and keep the first threader housing 30 attached to the second threader housing (not shown). A first stop portion or ramp 30-6 and a second stop portion 30-4 can also be included along a channel 30-8 (for an arm tip 40-18 of second threader housing 40 (see FIG. 22) to moved therein and therebetween), such that the first threader housing 30 can move from a first position (which is also controlled by stop 40-10, discussed above) to a second position with respect to the second threader housing (not shown) (i.e., undeployed position to a ready to be deployed position (i.e., sutures pulled through the implant by the threader), as explained below). FIG. 16 shows a top close-up view of the first threader housing 30 as shown in FIG. 15.

[0107] Referring to FIG. 17, a perspective view of the implant delivery system 10 with the top cover removed for illustration purposes is shown.

[0108] Referring now to FIGS. 18-20, top, bottom, and side perspective views of thesecond threader housing 40 are shown, respectively. As shown, cannulated inserter tube 70 can be positioned within the channel 40-12 of the second threader housing 40.

[0109] Referring to FIGS. 21-22, a close-up proximal view of the underside of the second threader housing 40 and a close-up side view of the second threader housing 40 are shown, respectively. The underside of the ridges 40-14 can be seen, as discussed above, as well as the channel 40-12. Referring specifically to FIG. 22, the second threader housing 40 can include an arm 40-16 and an arm tip 40-18 which are configured to contact the two stop portions of the first threader housing as explained above to allow for the movement from a first position to a second position with respect to the second threader housing (i.e., the arm tip 40- 18 can be positioned behind the first stop position of the first threader housing in the undeployed position and can move (by a user exerting a proximal force on the top threader housing 30 to overcome the opposite frictional force exerted by the ramp) up the ramp of the first stop position, through the channel, and be positioned within the second stop position of the first threader housing in the ready to be deployed position, see FIG. 15).

[0110] Referring to FIGS. 23-24, a rear view and bottom view of the proximal end 10- 2 of the implant delivery system 10 are shown, respectively. The handle 50 can include a variety of indents or recessed sections in which the threads 80 can be secured. The threads 80 can pass through the cannulated inserter tube 70, be secured within a recessed section 50-2 along the handle 50 (or another connected tube, same tube and angled down / through the handle, or through a cannulated and non-open on the sides handle portion), be wrapped around a proximal portion of the handle 50, and tied off and secured within another recessed section 50-4 within at the most proximal end of the handle 50, as an example.

[0111] Referring now to FIG. 25, a close-up perspective view of the proximal end 10- 2 of the implant delivery system is shown. Here, the arm tip 40-18 of the arm 40-16 is positioned against the first stop portion 30-6 of the first threader housing 30 (i.e., theundeployed position).

[0112] Referring now to FIG. 26A-D, a perspective side view of the implant delivery system 10 in the ready to deploy position (as explained further below) is shown. Here, the first threader housing 30 has been moved proximally by a user with respect to the second threader housing 40 and the handle 50 (rails 30-2 have moved along rails 40-14 (see FIG. 13), and rails 30-13 have moved within slots 40-13 (see FIGS. 26B-D) until the distal end of the rails 30-13 has moved proximally beyond the confines of the slots 40-13 and no longer being attached to the handle - while rails 30-2 is still under respective rails 40-14 and the proximal motion of the first threader housing 30 is stopped by arm tip 40-18; this configuration allows for the removal of both threader housings together in a proximal and upward motion away from the cannulated inserter tube and handle (as discussed below, and shown in the use related FIGS.). As shown in FIG. 27, in the position shown in FIG. 26A, the arm tip 40-18 of the arm 40-16 is now positioned within the second stop portion 30-4 of the first threader housing 30 (i.e., the ready to deploy position).

[0113] As shown in FIG. 28, the first and second threader housings 30 and 40 have been removed with respect to the rest of the implant delivery system 10 after the ready to deploy position has been reached (as explained herein). As shown in FIG. 29, first and second threader housings 30 and 40 have been fully removed and the implant delivery system 10 (here, the cannulated inserter tube 70 with distal foot connected to the implant 60, and handle 50) is ready to be inserted into a patient.

[0114] Referring to FIG. 30, an exploded side perspective view of the implant delivery system 10 is shown.

[0115] The next set of FIGS. 31-47 shows the embodiment of the implant delivery system, described above, in use during a simulated rotator cuff repair procedure.

[0116] Turning to FIG. 31 , a rotator cuff repair simulated procedure is shown accordingto an embodiment. Ref. no. 103 represents a patient’s skin, 105 represents the surgical site of a rotator cufl / repair through which sutures are pulled, and which are anchored underneath by knotless or other bone anchors, or otherwise in a tendon, and 101 represents a cannula (here, a lateral cannula) positioned through skin 103 over the surgical site through which surgical / medical devices can be passed (this set up should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). As shown, the distal end 10-1 of the implant delivery system 10 is brought over the proximal end of the cannula 101, and a suture grasper / retriever 201 is positioned through one of the openings 40-4.

[0117] Prior to the configuration and steps shown in and described with respect to FIG. 31, a medical practitioner can prepare for soft tissue surgical repair including placement of sutures as shown at and extending from the surgical site (medial fixation sutures 107-1 - 107- 4), and shown more clearly in FIG. 40. These sutures may be free mattress stitches placed in the rotator cuff tendon or be sutures from a suture anchor and passed through the tendon (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). The medical practitioner can select the implant delivery system size that is most appropriate for the suture placement and patient size, and can optionally hydrate the implant.

[0118] Turning to FIG. 32, the suture grasper 201 has passed through the cannula 101 and is at the surgical site grasping one of the sutures 107-1 extending from the surgical site.

[0119] As shown in FIG. 33, suture 107-1 has been pulled through the first of multiple holes 40-4 (here four holes, but can be six, for example). Retrieving sutures one at a time through the working cannula 101 can ensure that there are no suture tangles in the cannula. Multiple sutures (such as two #2 sutures / ribbons or one #2 and one tape) can be loaded through a single threader hole. Two ribbons are passed though the outer-most threader holes and none through the inner-most, as shown herein.

[0120] As shown in FIGS. 34-35, all suture strands 107-1 - 107-4 have been pulled through respective holes 40-4. After the medial fixation sutures have been loaded into the threader holes, the lengths of the sutures can be adjusted so that the lengths of the strands can be of equal or close to / substantially equal length (75-99% the same length). Also, as shown in FIG. 35, the user can hold the handle 50 with one hand and grab the first / top threader housing 30 just prior to the action shown in FIG. 36.

[0121] Turning to FIG. 36, while holding the handle, the user pulls the first threader housing 30 in the proximal direction, and the first threader housing 30 slides along the second threader housing 40 and the handle via rails and slots until the stop 30-4 is hit by the arm tip 40-18 of the arm 40-16, as discussed above. This action pulls / threads the medial sutures through the implant 60 from the distal surface through the proximal surface thereof by pulling the threaders through holes in the implant 60.

[0122] Turning to FIG. 37-38, the user continues to pull the first threader housing 30 proximally and slightly upwards, which pulls both the first threader housing 30 and the second threader housing 40 away from the handle 50 and the cannulated threader tube 70 while pulling the slack out of the sutures.

[0123] Turning to FIGS. 39 and 40, the user has removed the full threader housing, and is holding the handle 50 with one hand, which is still attached to the cannulated inserter tube 70 and the implant 60 with the sutures 107-1 - 107-4 pulled tight by the user’s other hand. Next, the user can move the implant 60 to and through the cannula 101 and then to the surgical site 105, while continuing to pull the suture 107-1 - 107-4 through the implant 60.

[0124] Referring to FIGS. 41-43, iterative steps are provided illustrating the implant 60 being pushed through the cannula 101 by the inserter 70 / foot of the inserter 70-6 to and at the rotator cuff tendon / surgical site 105 (through which sutures are pulled, and which are anchored underneath by knotless or other bone anchors, or otherwise in tendon, as should be understoodby those of ordinary skill in the art), according to an embodiment.

[0125] Referring to FIG. 44, the foot of the inserter 70-6 is holding the implant 60 at the medial row position at the surgical site 105. A set of two medial suture tails 107-3, 107-4 are retrieved though an accessory portal 301 and tied to establish medial fixation with a medial stitch / knot 303. The inserter 70 can preferably be removed (release lateral and retention suture / threads 80 from the inserter, as shown in FIG. 45, for example). This step can be repeated for the other medial sutures 107-1 and 107-2, either before or after removing the delivery instrument.

[0126] In FIG. 45, threads 80 connected to the handle 50 have been uncleated.

[0127] As shown in FIG. 46, the inserter 70 has been removed from the surgical site 105 and cannula 101 after the threads 80 have been uncleated.

[0128] Turning to FIG. 47A, a second set of two medial suture tails 107-1, 107-2 are retrieved though an accessory portal 301 and tied to establish further medial fixation with a medial stitch / knot 305. A medial stitch / knot 305 is not required, however, for successful use or to complete the procedure. Medical practitioner s / surgeons can choose not to tie medially and fix these sutures at the lateral row. An example of a final construct in this instance (completed rotator cuff augmentation without medial knots) is shown in FIG. 47B. Turning back to FIG. 47A, the retention stitch 60-6 has been removed from the implant 60, and any remaining knots are tied. Each of the lateral stiches 60-2 (optionally, with the medial stiches, as shown) can be each threaded into and fixed with a lateral row knotless anchor 307 to fixate the lateral aspect of the rotator cuff at the insertion site. Appropriate tension can be added to establish uniform distribution of load. The pre-loaded lateral stitches are not explicitly required. Some surgeons may choose to remove the pre-loaded lateral stitches by cutting them out prior to implantation.

[0129] Example fully deployed end results pursuant to certain techniques such asdouble row fixation, single row fixation or onlay fixation can be obtained (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

[0130] The following FIGS, relate to alternative embodiments of the implant delivery device, which can include one or more additional components or similar components (in structure and / or function) with some differences. Only the main additional aspects and / or differences are highlighted and discussed below. While various alternative embodiments are described herein, all embodiments and parts thereof can be combined in any way mechanically possible as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure.

[0131] In one alternative embodiment, the threader assembly can include a threader housing including threaders 401, a threader block 403, a threader tab 405, a cannulated inserter tube 70 with a handle 50’, and an implant 60, as shown in FIG. 48A. After the threaders 401 are loaded with the suture tails from the surgical site, the threader tab 405 can be pulled away from the other part(s) of the threader assembly and have a similar function on the suture tails, which are pulled through the implant 60 as described above with respect to the first threader housing 30 - proximally moving with respect to the second threader housing 40 (as shown in FIG. 48B).

[0132] Turning to FIG. 49, the implant is shown with medial suture pass through locations 60-8, the retention stitch 60-6, and a single tail mattress stitch 60-2. A foot 70-6 is also shown, which can be in line with the shaft, or at an angle thereto - e.g., 15 -25 degree bend (on the left, which has been found to be the most helpful angle for obtaining the functionality discussed herein), flat / straight / non-angled configuration is shown on the right.

[0133] Referring to FIGS. 50A-50B, close-up views of the top and middle threader holes 40-2’ and 40-4’ are shown with a threader 60-4’ positioned therethrough, in accordancewith an alternative embodiment. As shown, in this embodiment the shape of the threaders 60- 4’ and the slots in the threader holes 40-2’ allow a user to load the suture (not shown) through the holes 40-2’ and 40-4’ and pull the threaders 60-4’ forward from a first position (FIG. 50 A) to a second position (FIG. 50B) to “clip” the suture in place so that it does not fall out while the rest of the sutures are being loaded within the device 10’. In this embodiment, threaders 60- 4’ made out of stainless steel (or other similar material) were found to be most optimal.

[0134] Referring now to FIG. 51, another alternative embodiment of an implant delivery system 10” is shown. In this embodiment, a different version of the first threader housing 30” is positioned on the second threader housing 40”, but functions similarly to the embodiments described above. A sliding mechanism 50-6” can be integrated within the handle 50” which can actuate the first threader housing 30”. In some examples, the first threader housing 30” can be actuated manually instead.

[0135] FIGS. 52A-52B show perspective views of another alternative embodiment of an implant delivery system 10’”. In this embodiment, a first threader housing 30”’ can be slidably mounted to the second threader housing 40’” and function similarly to the first threader housing described above. As shown, the shape of the first and second threader housings 30’” and 40’” can have indents and rivets to provide ergonomic support for a user.

[0136] FIGS. 53A-53K show an additional alternative embodiment of an implant delivery system 10””. Referring to FIG. 52A, a perspective view of the implant delivery system 10”” is shown. In this embodiment, the first threader housing 30”” can include a locking mechanism 30-10”” that allows a first threader housing 30”” to move or detach from the second threader housing 40”” (see FIG. 53E) and / or release a sliding mechanism (not shown). As shown in FIG. 53B, a sliding mechanism 90”” can be slidably positioned between the first threader housing 30”” and the second threader housing 40”” to pull the threaders (not shown) as described above (see FIG. 53B). As shown in FIG. 53C, an alternative twist tab 30-12”” canbe provided to actuate the locking mechanism 30-10”” from a locked to an unlocked position. Referring to FIG. 53D, a close-up perspective view of the second threader housing 40”” is shown with the first threader housing and cannulated tube inserter removed for illustrative purposes. As shown, the threaders 60-4”” are positioned and function similarly to embodiments described above. Referring to FIG. 53F, the twist tab 30-12”” is in an upright position with respect to the first and second threader housings 30”” and 40”” and the locking mechanism 30- 10”” is in an unlocked position (compared to locked position shown in FIG. 53C).

[0137] Referring now to FIG. 53H, a block mechanism 92”” is shown coupled to the second threader housing 40””. In this example, the medial sutures 60-8”” are coupled to and extend from the block mechanism 92”” and allow the device to function similarly to embodiments described above. The block mechanism 92”” can move and pivot with respect to the second threader housing 40”” and can include six medial sutures 60-8””, as an example.

[0138] Referring now to FIG. 531, a perspective view of the second threader housing 40”” is shown with the first threader housing removed for illustration purposes. In this example, a disc 30-14”” can be rotatably coupled to and fit within the second threader housing 40”” to hold the inserter tube while it is in the undeployed position and release the inserter tube in the deployed position. The path of the grooves in the block mechanism 92”” control rotation of disc 30- 14 ”” so that the disc does not rotate and releases the shaft until the threaders are fully through the implant. In other words, the user can rotate 30-10””, which is configured to push back 92”” and the attached threaders through the implant. Once the threaders are through the implant, further rotation of 30-10”” pushes 92”” so that geometry in 92”” and 30-14”” cause 30-14”” to rotate, releasing the shaft. The disc 30-14’”’ can include openings on either side through which the cannulated tube inserter (not shown) can pass and extend through, similar to embodiments described above (see also, FIG. 53K). Referring to FIG. 53J, an example is shown of the locking mechanism 30-10”” that does not have a separate twist tab,but a piece that is integrally formed with the locking mechanism 30-10””, as an example.

[0139] FIGS. 54A-55 refer to another alternative embodiment of the implant delivery system 10””’ that has been designed to support the hydration of the implant 60””’ with biologic fluids including but not limited to blood, bone marrow aspirate, platelet-rich plasma, or cells from the same or a different donor (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). This can guide the immune response in a patient and promote faster healing and tissue regeneration (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

[0140] In the embodiment, a back plate of the implant delivery system 10””’ can be open, allowing for sufficient access to the entire implant 60’””, including all four edges, and tray-shaped, so as to allow the surgeon to apply biologies for the implant 60’”” to absorb. In some instances where the biologic is not able to stay absorbed in the implant 60” ” ’while being inserted down a cannula (not shown), the embodiments shown in FIGS. 54A-55 enable the biologic to be applied arthroscopically. These embodiments function and are structured similarly to embodiments described above, except the delivery of biologies are realized with a second tube, or multi-lumen shaft 72’””, that is positioned under or adjacent to the implant 60””’ (and also cannulated tube inserter) and is connected to the implant 60’”” by the retention stitch (not shown), as described above. In this example, the multi-lumen shaft 72’”” can have a flexible region 74””’ positioned near or adjacent to the implant 60’”” and the multi-lumen shaft 72’”” can deposit biologic material into and / or under the implant 60’””. The biologic fluid can enter the multi-lumen shaft 72” ’” via a port 52’”” in the back of the implant delivery system 10’”” where a syringe or other device to push the biologic is connected to the port 52’””. In some embodiments, as shown in FIG. 55, the handle 50’”” can be configured to function as a syringe or similar device 54” ” ’ to push the biologic throughthe multi-lumen shaft 72””’ and into and / or under the implant 60””’. In some embodiments, when the retention stitch is removed, both the implant 60’”” and the end of the multi-lumen shaft 72’”” can be released. The multi-lumen shaft 72’”” can remain connected to the rest of the implant delivery system 10”’” and be removed from the implant site with the rest of the implant delivery system 10’””, leaving only the implant 60’””, sutures (not shown), and biologic. In some examples, the multi-lumen shaft 72 ” ” ’ can be positioned within or integrally formed with the cannulated tube inserter (not shown).

[0141] Turning to FIG. 56, an alternative embodiment of the implant delivery system that does not come preloaded with lateral stitches and includes threaders 60-15 (lateral threaders) to load sutures through a lateral edge of the implant 60 is shown. In use, the suture loaded into the lateral edge of the implant would come from suture anchors inserted at the lateral aspect for the rotator cuff repair.

[0142] Referring to FIG. 57, shows an alternative embodiment of the implant delivery system without pre-loaded lateral stitches, and with threaders 60-4’ that are configured to pull suture though the medial row 60-17, across the implant, then through the lateral row 60-19.

[0143] Referring to FIG. 58, shows an alternative embodiment of the implant delivery system with separate medial 60-4 and lateral threaders 60-4-1 to achieve the same result as shown and discussed with respect to FIG. 57. The implant 60 is shown as being translucent with a two stage threader system (60-4 and 60-4-1). In use, the four medial threaders 60-4 are configured to pull the sutures through the medial holes of the implant and into an eyelet of each of the lateral threaders 60-4-1. The lateral threaders 60-4-1 are configured with a delay by being a longer length than the medial threaders 60-4 to ensure the medial threaders 60-4 have pulled first. Then the lateral threaders 60-4-1 pull, with the single pull of the housing / slide (as discussed herein) and pull the sutures through the lateral holes of the implant. In other words, the lateral threaders 60-4-1 are of a longer length so that the medial threaders 60-4 pull thesuture through the implant 60 and lateral threaders 60-4-1 before the lateral sutures engage the material in the threader’s eyelet when the slide connected to all of the threaders is pulled in a single motion. Alternatively, the medial and lateral threaders may be on separate portions of the housing / slides that move and can be actuated by the user separately.

[0144] Turning to FIGS. 59-62, various views of an alternative embodiment of the implant delivery system is shown. Because the sutures (not shown) being pulled though the lateral row 60-19 are being pulled away from the back plate surface 40-8, the implant 60 may be supported with a sliding retention component 60-21 with lateral edge support. FIG. 59 shows the sliding retention component 60-21 in a closed position with support for the lateral edge of the implant and locked to the inserter tube at 60-21-1. FIG. 60 shows a catch 60-21-3 that is configured to move the sliding retention component 60-21 to release from the inserter tube, by rocking or sliding distally (or proximally in another embodiment). FIG. 61 shows a first threader housing 30-1 slidably coupled to a second threader housing 40-1 in a similar manner as discussed above with other embodiments of the first threader housing. The first threader housing 30-1 is pulled / slid proximally to its deployed state to push back the catch 60- 21-3 to release the sliding retention component 60-21 to release from the inserter tube. FIG. 62 shows the sliding retention component (lateral support feature) 60-21 it its deployed state, clear of the implant 60. FIG. 62 also shows the catch of lock portion 60-21-1 which has flexed open and released the inserter tube, and the first threader housing 30-1 in its deployed state slide proximally on the second threader housing 40-1.

[0145] While embodiments of the 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 the inventive features of the embodiments as defined by claims that can be supported by the written description and drawings. Further, where exemplary embodimentsare described with reference to a certain number of elements it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements.

[0146] 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 teachings is / 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.

[0147] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the inventive features of the embodiments. 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.

[0148] 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. Descriptions of the embodiments have been presented for purposes of illustration and description but is not intended to be exhaustive or limited to the inventive features of the 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 inventive features of the embodiments. The embodiments were chosen and described in order to best explain the principles of one or more aspects of the inventive features of the embodiments and the practical application, and to enable others of ordinary skill in the art to understand one or more aspects of the inventive features for various embodiments with various modifications as are suited to the particular use contemplated.

Claims

What is claimed is:

1. A bioinductive implant delivery system, comprising: a bioinductive implant having at least a first aperture through which an opening portion of a first threader is positioned in a predeployment configuration, and through which a first suture can be positioned in a ready to be deployed configuration; and a delivery instrument having a distal end and a proximal end, a shaft extending between the distal end and the proximal end, and a distal foot portion attached to a distal end of the shaft, wherein the bioinductive implant is connected to the distal foot portion.

2. The implant delivery system of claim 1, further comprising a threader housing through which the shaft passes.

3. The implant delivery system of claim 2, wherein the housing comprises a first threader housing and a second threader housing.

4. The implant delivery system of claim 3, wherein the first threader housing is slidably coupled to the second threader housing and is configured to move from first position to a second position to change the implant from the predeployment configuration to the deployed configuration,, respectively.

5. The implant delivery system of claim 4, wherein when the first threader housing moves from the first position to the second position the first threader housing is configured to move a portion of the first suture through the implant.

6. The implant delivery system of claim 5, further comprising a handle portion attached to a proximal end of the shaft and wherein the handle portion is attached to the housing.

7. The implant delivery system of claim 6, wherein the first threader housing and the second housing are configured to be removed from the shaft and the handle portion when the first threader housing is in the second position.

8. The implant delivery system of claim 3, wherein the second threader comprises a surface on the distal end on which the implant is positioned in the predeployment configuration.

9. The implant delivery system of claim 3, wherein the second threader housing comprises an opening within which the opening portion of the first threader is positioned.

10. The implant delivery system of claim 3, wherein the second threader housing comprises a surface to prevent the first threader housing from sliding distally beyond a certain predetermined position.

11. The implant delivery system of claim 3, wherein the second threader housing comprises a surface to prevent the first threader housing from sliding proximally beyond a certain predetermined position.

12. The implant delivery system of claim 1, wherein the shaft is cannulated.

13. The implant delivery system of claim 12, wherein the implant comprises at least one retention suture positioned therethrough.

14. The implant delivery system of claim 13, wherein the at least one retention suture extends through the cannulated shaft.

15. A method of delivering a bioinductive implant, comprising: providing a bioinductive implant delivery system comprising: a bioinductive implant having at least a first aperture; a delivery instrument having a shaft and a distal foot portion attached to the shaft, wherein the bioinductive implant is connected to the distal foot portion, and a first threader positioned through the at least first aperture; capturing a first suture extending from a repair site with the first threader; pulling the first suture through the first aperture; forming a knot with the first suture at the repair site; and removing the delivery instrument from the repair site.

Images