Implant delivery system

Abstract

The present disclosure generally relates to an implant delivery system, and more specifically to a bio-induced implant delivery system and method.

Description

Technology Field

[0001] The present disclosure generally relates to implant delivery systems, and more specifically to bioinductive and biocomposite implant delivery systems and methods. Background Technology

[0002] Conventional surgical implants and related delivery systems are known. Disclaimer regarding the relevant technical section: To the extent that specific patents / publications / products are discussed in this background section or elsewhere in this application, such discussions should not be construed as an acknowledgment that the discussed patents / publications / products constitute 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 a subject matter developed sufficiently early in time, and / or may not be sufficiently feasible to constitute prior art for patent law purposes. To the extent that specific patents / publications / products are discussed in this background section and / or throughout the entire application, their descriptions / disclosures are all incorporated into this specification by reference in their respective wholes.

[0003] The inventors of the present disclosure recognize that problems exist associated with certain conventional surgical implants (e.g., bio-induced / bio-composite implants) and related delivery systems, and that there is a need for improved implants and related delivery systems and methods. For example, certain conventional surgical implants are provided only as implants. During the surgical procedure, surgeons must currently manually pass sutures through the implant and use several different instruments to introduce and control the implant within the subacromial space. Due to the specific structures and strengths of certain implants, existing suture passers cannot reliably pass sutures through them (the sutures may get caught or tangled) and may damage the implants. Additionally, due to the manual nature of suture passage, the user may place the suture too close to the edge of the implant, which may result in a reduction in the strength of the final augmentation structure (as should be understood by those skilled in the art with a review of the present disclosure). Medial sutures are typically passed through the implant away from the surgical site, whereas lateral sutures are often passed through the surgical site along with the implant to avoid entanglement of the sutures while introducing the implant into the subacromial space. This presents all the difficulties described above and exacerbates these difficulties by performing suture passage under an arthroscope. Therefore, there is a need in the field of technology for an improved bio-guided and bio-composite implant delivery system.

[0004] Accordingly, the primary object and benefit of the present disclosure is to provide a bio-guided / bio-composite implant and an improved delivery system and method thereof that eliminate one or more problems / issues / defects associated with conventional devices / systems. Devices / assemblies / systems of one embodiment may be used during arthroscopic rotator cuff repair and similar surgical procedures in which bio-guided / bio-composite implants are used or may be used (as should be understood by those skilled in the art with a review of the present disclosure). In particular, the present disclosure relates to embodiments of devices / assemblies / systems of the present invention configured to deliver bio-guided / bio-composite implants that facilitate implantation during the aforementioned surgical procedures. A non-limiting objective associated with embodiments of devices / assemblies / systems of the present invention is to ensure that strength is maintained by enabling a user to easily load sutures onto the inner edge of the implant at predetermined locations. To avoid the issues of manually passing such sutures, the outer edge of the implant may be pre-sutured with sutures. Implants pre-sutured with lateral sutures can be provided to the user, detachably attached to a delivery system or inserter. This allows the user to introduce and control the implant within the subacromial space. The delivery system can also prevent entanglement by keeping the lateral sutures managed until the delivery system is removed (during introduction, the pre-sutured lateral stitches may remain inside the delivery system shaft to prevent entanglement with the medial stitches passed through the passers).

[0005] As described and illustrated in this specification, and according to one embodiment, an implant having an implant inserter / delivery system may comprise an implant pre-sutured with sutures (e.g., HI-FI sutures) that are pre-loaded and attached to a delivery / inserter system / assembly. The delivery / inserter system / assembly may comprise a passer assembly for facilitating the passage of sutures through the implant, and an inserter assembly for facilitating the placement of the implant into the patient's subacromial space. The implant may be provided in a plurality of sizes including, but not limited to, 23x25 mm and 35x25 mm. The length and width may differ in these embodiments (but do not need to differ in other embodiments), while the thickness may be the same / consistent in certain embodiments (which is preferred) but may not be so in other embodiments.

[0006] These and other aspects of the embodiments of the present disclosure will become apparent and will be explained with reference to the embodiment(s) described below. Brief explanation of the drawing

[0007] Embodiments of the present disclosure will be more fully understood and recognized by reading the following detailed description in conjunction with the accompanying drawings. The accompanying drawings illustrate only typical embodiments of the disclosed subject material and should not be construed as limiting its scope, as the disclosed subject material may allow for other equally effective embodiments. The accompanying drawings are now briefly referenced, wherein: FIG. 1 is a schematic side view of an implant delivery system according to one embodiment. FIG. 2 is a schematic perspective view of the distal end of an implant delivery system according to one embodiment. FIG. 3 is a schematic diagram of the proximal end of an implant delivery system according to one embodiment. FIG. 4 is a schematic bottom view of an implant delivery system according to one embodiment. FIG. 5 is a schematic bottom perspective view of an implant delivery system according to one embodiment. FIG. 6a is a schematic enlarged bottom view of the distal end of an implant delivery system according to one embodiment. FIG. 6b is a bottom view of the distal end of an alternative embodiment of an implant delivery system. FIG. 7 is a schematic diagram of another enlarged bottom view of the distal end of an implant delivery system according to one embodiment. FIG. 8 is a schematic enlarged plan view of the distal end of an implant delivery system according to one embodiment. FIG. 9 is a schematic enlarged perspective view of the distal end of an implant delivery system according to one embodiment. FIG. 10 is a schematic diagram of another enlarged bottom view of the distal end of an implant delivery system according to one embodiment. FIG. 11 is a schematic enlarged plan view of another distal end of an implant delivery system according to one embodiment. FIG. 12 is a schematic enlarged bottom perspective view of another distal end of an implant delivery system according to one embodiment. FIG. 13 is a schematic enlarged bottom perspective view of an implant delivery system according to one embodiment. FIG. 14 is a schematic enlarged bottom perspective view of an implant delivery system according to one embodiment. FIG. 15 is a schematic enlarged bottom perspective view of an implant delivery system according to one embodiment. FIG. 16 is a schematic enlarged plan view of another distal end of an implant delivery system according to one embodiment. FIG. 17 is a schematic perspective view of an implant delivery system with the upper cover removed for exemplary purposes, according to one embodiment. FIG. 18 is a schematic plan view of a second pass-through housing of an implant delivery system according to one embodiment. FIG. 19 is a schematic bottom view of a second pass-through housing of an implant delivery system according to one embodiment. FIG. 20 is an enlarged perspective schematic diagram of a second pass-through housing of an implant delivery system according to one embodiment. FIG. 21 is a schematic enlarged bottom view of the proximal end of the second pass-through housing of an implant delivery system according to one embodiment. FIG. 22 is a schematic enlarged side view of the proximal end of the second pass-through housing of an implant delivery system according to one embodiment. FIG. 23 is a schematic perspective view of the proximal end of an implant delivery system according to one embodiment. FIG. 24 is a schematic enlarged bottom view of the proximal end of an implant delivery system according to one embodiment. FIG. 25 is a schematic diagram of another enlarged bottom view of an implant delivery system according to one embodiment. FIG. 26a is a schematic perspective view of an implant delivery system moving toward a deployment preparation position according to one embodiment. FIG. 26b is a schematic enlarged bottom view of the proximal end of an implant delivery system according to one embodiment. FIG. 26c is a schematic diagram of another enlarged bottom view of the proximal end of an implant delivery system according to one embodiment. FIG. 26d is a schematic diagram of another enlarged bottom view of the proximal end of an implant delivery system according to one embodiment. FIG. 27 is a schematic diagram of another bottom view of an implant delivery system according to one embodiment. FIG. 28 is a schematic diagram of an exploded side view of an implant delivery system according to one embodiment. FIG. 29 is a schematic diagram of another exploded perspective view of an implant delivery system according to one embodiment. FIG. 30 is a schematic exploded view of an implant delivery system according to one embodiment. FIG. 31 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 32 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 33 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 34 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 35 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 36 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 37 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 38 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 39 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 40 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 41 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 42 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 43 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 44 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 45 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 46 shows the steps in a process using an implant delivery system according to one embodiment. FIG. 47a shows the steps in a process using an implant delivery system according to one embodiment. FIG. 47b shows a completed rotator cuff augmentation without medial knots according to one embodiment. FIG. 48a is a schematic diagram of the side and top views of an implant delivery system according to one embodiment. FIG. 48b shows the steps in a process using an implant delivery system according to one embodiment. FIG. 49 is a schematic side and top view of an implant delivery system with the housing removed for exemplary purposes according to one embodiment. FIG. 50a is a schematic enlarged view of the distal end of an implant delivery system according to an alternative embodiment. FIG. 50b is a schematic enlarged view of the distal end of an implant delivery system according to an alternative embodiment. FIG. 51 is a schematic bottom view of an implant delivery system according to an alternative embodiment. FIG. 52a is a schematic top perspective view of an implant delivery system according to an alternative embodiment. FIG. 52b is a schematic top perspective view of another implant delivery system according to an alternative embodiment. FIG. 53a is a schematic top perspective view of an implant delivery system according to an alternative embodiment. FIG. 53b is a schematic diagram of the top disassembly of an implant delivery system according to an alternative embodiment. FIG. 53c is a schematic plan view of another implant delivery system according to an alternative embodiment. FIG. 53d is a schematic plan view of another implant delivery system according to an alternative embodiment. FIG. 53e is a schematic perspective view of an implant delivery system according to an alternative embodiment. FIG. 53f is another plan view schematic of an implant delivery system according to an alternative embodiment. FIG. 53g is another plan view schematic of an implant delivery system according to an alternative embodiment. FIG. 53h is a schematic enlarged perspective view of the distal end of an implant delivery system according to an alternative embodiment. FIG. 53i is a schematic enlarged plan view of the proximal end of an implant delivery system according to an alternative embodiment. FIG. 53j is a schematic top perspective view of an implant delivery system according to an alternative embodiment. FIG. 53k is a schematic bottom perspective view of an implant delivery system according to an alternative embodiment. FIG. 54a is a schematic bottom perspective view of an implant delivery system according to an alternative embodiment. FIG. 54b is a schematic side view of an implant delivery system according to an alternative embodiment. FIG. 55 is a schematic side view of an implant delivery system according to an alternative embodiment. FIG. 56 is a bottom view of the distal end of an alternative embodiment of an implant delivery system. FIG. 57 is a bottom view of the distal end of an alternative embodiment of an implant delivery system. FIG. 58 is a bottom view of the distal end of an alternative embodiment of an implant delivery system. FIG. 59 is an enlarged bottom perspective view of the distal end of an alternative embodiment of an implant delivery system. FIG. 60 is a top perspective view of the distal end of an alternative embodiment of an implant delivery system. FIG. 61 is a top perspective view of the distal end of an alternative embodiment of an implant delivery system. FIG. 62 is an enlarged bottom perspective view of the distal end of an alternative embodiment of an implant delivery system. Specific details for implementing the invention

[0008] Aspects of the embodiments and their specific features, advantages, features of the invention, and details thereof are described 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 features of the embodiments of the invention. However, it should be understood that the detailed description and specific non-limiting examples illustrate aspects of the features of the embodiments of the invention, but are given merely as examples and not as limitations. Various substitutions, modifications, additions, and / or arrangements within the spirit and / or scope of the underlying concepts of the invention will be apparent to those skilled in the art from this disclosure.

[0009] Although embodiments of the present disclosure have been specifically shown and described with reference to specific exemplary embodiments, it will be understood by those skilled in the art that various modifications of the details may be made within the spirit and scope of the features of the invention as defined by the claims supported by the written description and drawings. Furthermore, where exemplary embodiments are described with reference to a specific number of elements or steps, it will be understood that the exemplary embodiments may be practiced using fewer or more elements or steps than the specific number of elements or steps. Where elements depicted in a specific drawing discussed below are not specifically identified in relation to that drawing, the elements should be sufficiently identified in relation to at least one other drawing (and / or as should be appreciated by those skilled in the art with reference to the present disclosure).

[0010] The present disclosure relates to bio-induced or reinforced bio-induced / biocomposite implants used for soft tissue augmentation, and their delivery to a surgical site by a medical professional. In one or more embodiments, the bio-induced or reinforced bio-induced implant comprises the applicant’s “BioBrace” implant (BioBrace®, U.S. Trademark No. 6569750; Product – Bioabsorbable tissue-engineered scaffold implant that facilitates the regeneration of new tissue, i.e., a tissue-engineered scaffold implant made of collagen, which is a biological material, and a polymer that is internally implanted by a surgeon into the patient’s body, which is fully bioabsorbable and remodeled into functional tissue that allows the patient’s body to heal itself without the pain and risks associated with traditional surgical implants; owned by the applicant; and, for example, Product Nos. BB23X25 and BB35X25). As used herein, BioBrace or implant may refer to the aforementioned products and / or sutures, hard anchors, and bio-induced or reinforced bio-induced implants that are sufficiently durable to support cannula passage. BioBrace or implant may feature a highly porous type 1 collagen matrix (e.g., 20 μm average pore size) reinforced with bioabsorbable PLLA microfilaments (e.g., 15 μm diameter). BioBrace or implant may include a biological scaffold that can provide supplementary strength through load sharing, facilitate and optimize healing, and provide supplementary strength for about two years before being naturally absorbed. Unlike traditional implant materials that are either synthetic or biological, BioBrace® or implant may be a biocomposite of both. BioBrace or implant may also include the composite scaffold products and methods exemplified and described in U.S. Patent Publication No. 20210161645.

[0011] According to one embodiment, the implant may be an absorbable implant provided after being finally sterilized by ethylene oxide sterilization. As such, the implant may have a sterile barrier that is also a moisture barrier. The entire packaging system may include, for example, an insert tray located inside the sterile barrier, which may hold the product and facilitate aseptic delivery to a sterile field; a foil pouch—which is a sterile barrier of the device and may include a Tyvek® header that is removed after sterilization and sealing of the foil pouch (the insert tray and the device may be contained within the foil pouch); and an SBS cardboard box—which may be an outer cardboard box containing the foil pouch and contents.

[0012] As discussed herein, exemplary primary functions of a delivery system of one embodiment include one or more of the following: providing a user with an implant pre-sutured with single-tail mattress stitches at the outer edge; enabling the user to load sutures by passing the implant at predefined locations on the inner edge (e.g., 2, 4, 6, and 8 locations); and enabling the user to insert the implant into the patient's subacromial space by passing a cannula.

[0013] Now, referring to drawings in which similar parts are referred to by similar reference numbers, an embodiment of an implant delivery system (10) is illustrated and described, which includes fully assembled views, views of specific components, enlarged views, and exploded views.

[0014] FIGS. 1 through 3 show fully assembled views of an implant delivery system (10) according to one embodiment of the present disclosure. Returning to FIG. 1, a perspective side view of a fully assembled implant delivery system (10) is illustrated according to one embodiment of the present disclosure. As illustrated, the implant delivery system (10) has a distal end (10-1) and a proximal end (10-2), an upper cover (20), a first / upper passer housing (30), and a second / lower passer housing (40). A handle (50) may be located at and connected to the proximal end (10-2) of the implant delivery system (10). As further discussed below, the upper cover (20) and the first / upper passer housing (30) are movably connected to the second / lower passer housing (40). A separate upper cover (20) is not required and may be part of the integral structure of the first / upper passer housing (30). However, in a specific embodiment where a separate upper cover (20) is present, the upper cover (20) may be snap-fitted, friction-fitted, adhesive-fitted (or other connecting means as should be understood by those skilled in the art with a review of the present disclosure) to the first / upper pass-through housing (30), and the first / upper pass-through housing (30) may be slidably connected (via flange / rail and rail / groove) to the second / lower pass-through housing (40) and the handle (50).

[0015] Returning to FIGS. 2 and FIGS. 3, the upper distal view and upper proximal view of the implant delivery system (10) are respectively shown.

[0016] Referring to FIGS. 4 and FIGS. 5, a bottom view and a bottom perspective view of the implant delivery system (10) are respectively shown.

[0017] Now, referring to FIGS. 6a and FIGS. 7, a bottom view and a bottom view (with the implant (60) removed) of the distal end (10-1) of the implant delivery system are respectively shown. As further described below, upper pass holes (40-2) and middle pass holes (40-4) may be formed through the second pass housing (40) to help capture and pull the sutures through the implant (60) at the inner suture positions (60-8) and through the lower pass holes (40-6), as will be explained below. In this example, the implant (60) may be a PLLA-collagen scaffold that can be implanted into a patient, as should be understood by those skilled in the art with a review of the present disclosure. Also in this example, the pass holes (60-4) may have a nitinol eyelet and a stainless steel shaft sleeve. Once passed through the holes (40-4), the nitinol wire can be pulled back to the upper side of the second pass-through housing (40) through the implant from the holes of the pass-through back plate.

[0018] Returning to FIG. 6b, a bottom view of the distal end (10-1) of an alternative embodiment of an implant delivery system is shown. Specifically, all other components are identical or similar, and this embodiment is a 6-pass (60-4) version for an implant of a 35x35 mm implant version (although other sizes of implants may be used as should be understood by those skilled in the art with a review of this disclosure).

[0019] The implant (60) may also have one or more retaining stitches (60-6) and single tail mattress stitches (60-2) (and corresponding openings formed through them, not shown). As described below, the retaining sutures and outer sutures (collected threads (80)) can connect the implant (60) to an elongated cannular insertion tube / shaft (70) and form stitches (60-6, 60-2) (or other similar suture-like material) that can pass through a first opening (70-2) within the cannular insertion tube (70) and pass to the proximal end of the device (they can also pass through separate holes on the sides of the tube, respectively, as shown extended in FIG. 6b). In this example, the single-tail mattress stitches may be pre-loaded stitches that allow the user to secure the outer edge of the implant (60) and are formed from outer sutures. The retaining stitch may be a length of high-strength suture that is used to retain the implant on the foot (70-6) of the cannula-type inserter tube (70) but can be removed and is not permanently implanted in the patient. In some embodiments, the retaining stitch (60-6) may pass through a second opening (70-4) in the cannula-type inserter tube (70) to further secure the implant (60) to the cannula-type inserter tube (70) and allow the implant (60) to move together with the cannula-type inserter tube (70) as the implant delivery system (10) moves from the un-extended position to the extended position as described further below. Next, a portion of the retaining stitch (60-6) can pass through the first opening (70-2) of the cannula-type insertion tube (70) and pass to the proximal end of the device.

[0020] Now, referring to FIGS. 8 and FIGS. 9, an enlarged bottom view and a bottom perspective view of the distal end (10-1) of the implant delivery system (10) are respectively shown. Specifically, referring to FIG. 8, a portion of the cannula-type insertion tube (70) and the first pass-through housing (30) is removed for exemplary purposes. As described below, the surface (40-8) of the second pass-through housing (40) can provide a surface structure and an attachment / base interface to which the implant (60) can be stabilized while inner sutures (not shown) pass through it and are inserted.

[0021] Referring to FIGS. 10 through 12, enlarged views of the distal end (10-1) of the implant delivery system (10) are shown. FIG. 10 shows a bottom view of a first passer housing (30) in which a cannula-type insertion tube (70) is positioned thereon and passers (60-4) extend from it (with the second passer housing (40) removed). FIG. 11 shows the same bottom view as FIG. 10 with the first passer housing (30) removed and the upper cover (20) positioned underneath. FIG. 12 shows a side view of the view illustrated in FIG. 11.

[0022] Now, referring to FIG. 13, an enlarged bottom view of the second passer housing (40) is shown, in which a portion of the second passer housing (40) is located within the first passer housing (30). As can be seen, the second passer housing (40) may further include a channel (40-12) in which a cannula-type insertion tube (70) may be located inside. In this embodiment, the cannula-type insertion tube (70) and the handle (50) may be kept fixed (or movable according to human perspective) to both housings, whereas the first passer housing (30) may be moved toward the proximal end (10-2) along the elongated protrusions (40-14) of the second passer housing (40) via an elongated rail or protrusion (30-2), which will be described further below. The second passer housing (40) may include one or more protrusions (40-10) that act as a "stop" by contacting the first / upper passer housing (30) as illustrated and prevent the first passer housing (30) from moving too far in a distal direction relative to the second passer housing (40) (and prevent the first passer housing (30) and the upper cover (20) from affecting the proper function of the passers (60-4), as described below).

[0023] Referring to FIG. 14, an enlarged bottom view of the first passer housing (30) with the second passer housing (40) and the cannula-type inserter tube (70) removed for exemplary purposes is shown. As illustrated, the threads (80) (i.e., the retaining stitches (60-6) and single tail mattress stitches (60-2) as discussed above) may be positioned within the cannula-type inserter tube (not shown) and may extend from the implant (not shown) through the end of the device to the handle (not shown), which will be discussed further below.

[0024] Now, referring to FIG. 15, an enlarged bottom view of the first / upper passer housing (30) is shown. The first passer housing (30) may include one or more protrusions (30-2) that sit on the protrusions of the second passer housing (e.g., see FIG. 13) and slide along (and move relative to) them, thereby keeping the first passer housing (30) attached to the second passer housing (not shown). The first stop or inclined portion (30-6) and the second stop portion (30-4) may also be included along the channel (30-8) so that the arm tip (40-18) (see FIG. 22) of the second passer housing (40) moves within and between them, allowing the first passer housing (30) to move from a first position (which is also controlled by the stop portion (40-10) discussed above) to a second position relative to the second passer housing (not shown) (i.e., from an un-extended position to a ready-to-extend position (i.e., a state in which sutures are pulled through the implant by the passer), as described below). FIG. 16 shows an enlarged plan view of the first passer housing (30) as shown in FIG. 15.

[0025] Referring to FIG. 17, a perspective view of an implant delivery system (10) with the upper cover removed for exemplary purposes is shown.

[0026] Now, referring to FIGS. 18 through 20, a top view, a bottom view, and a side view of the second pass-through housing (40) are respectively shown. As shown, a cannula-type insertion tube (70) can be positioned within the channel (40-12) of the second pass-through housing (40).

[0027] Referring to FIGS. 21 and 22, an enlarged proximal view of the bottom surface of the second pass-through housing (40) and an enlarged side view of the second pass-through housing (40) are respectively shown. Not only can the bottom surface of the protrusions (40-14) as discussed above be shown, but the channel (40-12) can also be shown. Specifically, referring to FIG. 22, the second passer housing (40) may include an arm (40-16) and an arm tip (40-18), which are configured to contact the two stop portions of the first passer housing as described above to allow movement of the second passer housing from a first position to a second position (i.e., the arm tip (40-18) may be located behind the first stop portion of the first passer housing in the un-extended position and may move upward along the slope of the first stop portion, through the channel, to be located within the second stop portion of the first passer housing in the ready-to-extend position (by applying a proximal force to the upper passer housing (30) to overcome the opposing frictional force applied by the slope, see FIG. 15).

[0028] Referring to FIGS. 23 and 24, a rear view and a bottom view of the proximal end (10-2) of the implant delivery system (10) are respectively shown. The handle (50) may include various indents or recessed sections to which threads (80) can be secured. As an example, the threads (80) may pass through a cannula-type insertion tube (70), be secured within a recessed section (50-2) provided along the handle (50) (or another connected tube, the same tube passing through the handle downward / obliquely, or passing through a cannula-type handle portion where the sides are not open), be wrapped around the proximal part of the handle (50), and be tied and secured within another recessed section (50-4) at the most proximal end of the handle (50).

[0029] Now, referring to FIG. 25, an enlarged 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 in contact with the first stop portion (30-6) of the first pass-through housing (30) (i.e., unextended position).

[0030] Now, referring to FIGS. 26a through 26d, a perspective side view of an implant delivery system (10) moving toward a deployment preparation position according to one embodiment is shown. Here, the first passer housing (30) is moved proximately by the user relative to the second passer housing (40) and the handle (50) (rails (30-2) are moved along the rails (40-14) (see FIG. 13), and the rails (30-13) are moved within the slots (40-13) until the distal end of the rails (30-13) moves proximately beyond the boundary of the slots (40-13) and is no longer attached to the handle (see FIG. 26b to 26d), while the rails (30-2) are still under each rail (40-14) and the proximate movement of the first passer housing (30) is stopped by the arm tip (40-18); this configuration allows both passer housings to be removed together in proximate and upward movement away from the cannula-type insertion tube and the handle (as discussed below and illustrated in the drawings related to use). FIG. As shown in Fig. 27, at the position shown in Fig. 26a, the arm tip (40-18) of the arm (40-16) is now located within the second stop portion (30-4) of the first pass-through housing (30) (i.e., the deployment ready position).

[0031] As illustrated in FIG. 28, after reaching the deployment preparation position, the first and second pass-through housings (30, 40) were removed from the remainder of the implant delivery system (10) (as described herein).

[0032] As illustrated in FIG. 29, the first and second pass-through housings (30, 40) are completely removed, and the implant delivery system (10) (here, a cannula-type insertion tube (70) having a distal end connected to the implant (60), and a handle (50)) is ready to be inserted into the patient.

[0033] Referring to FIG. 30, a disassembled view of the implant delivery system (10) is shown.

[0034] The following set of Figures 31 to 47 shows an example of the implant delivery system described above, used during a simulated rotator cuff suturing procedure.

[0035] Returning to FIG. 31, a simulated rotator cuff suture procedure according to one embodiment is illustrated. Reference numeral 103 represents the skin of a patient, 105 represents a surgical site of a rotator cuff / suture through which sutures are passed and pulled and anchored from below by knotless or other bone anchors or otherwise within a tendon, and 101 represents a cannula (here, a lateral cannula) positioned through the skin (103) over the surgical site through which surgical / medical devices can pass (this setting should be understood by those skilled in the art with a review of the present disclosure).

[0036] As described, the distal end (10-1) of the implant delivery system (10) is brought over the proximal end of the cannula (101), and the suture grasper / retrieval device (201) is positioned through one of the openings (40-4).

[0037] Prior to the configurations and steps illustrated and described with respect to FIG. 31, a medical professional may prepare for soft tissue surgical suturing, including the placement of sutures as illustrated and more clearly illustrated in FIG. 40, which are placed on and extending from the surgical site (medial fixation sutures (107-1 to 107-4)). These sutures may be free mattress stitches placed within the rotator cuff tendons or sutures from suture anchors and may pass through the tendons (as should be understood by those skilled in the art with a review of the present disclosure).

[0038] Medical professionals can select the most appropriate implant delivery system size for suture placement and patient size, and can optionally hydrate the implant.

[0039] Returning to Fig. 32, the suture grasper (201) passes through the cannula (101) and grasps one of the sutures (107-1) extending from the surgical site.

[0040] As illustrated in FIG. 33, the suture (107-1) is pulled through the first of the plurality of holes (40-4) (here, four holes, but, for example, six). Retrieving the sutures one at a time through the operating cannula (101) can ensure that there is no entanglement of the sutures within the cannula. Multiple sutures (e.g., two #2 sutures / ribbons or one #2 and one tape) can be loaded through a single pass-through hole. As illustrated herein, two ribbons are passed through the outermost pass-through holes, and nothing is passed through the innermost holes.

[0041] As illustrated in FIGS. 34 and 35, all suture strands (107-1 to 107-4) are pulled through their respective holes (40-4). After the inner fixing sutures are loaded into the pass-through holes, the lengths of the sutures can be adjusted so that the strands are of equal or nearly / substantially equal length (75-99% equal length). Additionally, as illustrated in FIG. 35, the user can grasp the first / upper pass-through housing (30) with one hand by holding the handle (50) immediately before the action illustrated in FIG. 36.

[0042] Returning to FIG. 36, while holding the handle, the user pulls the first passer housing (30) proximally, and the first passer housing (30) slides along the second passer housing (40) and the handle through the rails and slots until the stop (30-4) as discussed above is struck by the arm tip (40-18) of the arm (40-16). This action pulls / threads the inner sutures through the implant (60) from its distal surface through its proximal surface by pulling the passers through the holes in the implant (60).

[0043] Returning to FIGS. 37 and 38, the user continues to pull the first passer housing (30) proximally and slightly upward, which pulls both the first passer housing (30) and the second passer housing (40) away from the handle (50) and the cannula-type passer tube (70) while pulling slack from the sutures.

[0044] Returning to FIGS. 39 and 40, the user has removed the entire pass-through housing and is holding the handle (50) with one hand, which is still attached to the cannula-type insertion tube (70) and the implant (60), while the sutures (107-1 to 107-4) are being held tightly by the user's other hand. Next, the user can move the implant (60) to the cannula (101) and then to the surgical site (105) while the user passes through the implant (60) and continues to pull the sutures (107-1 to 107-4).

[0045] Referring to FIGS. 41 through 43, according to one embodiment, repetitive steps are provided illustrating the implant (60) being pushed into and therein through a cannula (101) by the foot of an inserter (70) / inserter (70-6) to a rotator cuff tendon / surgical site (105) (wherein sutures are pulled and anchored from below by knotless or other bone anchors, or otherwise anchored within the tendon, as is understood by those skilled in the art).

[0046] Referring to FIG. 44, the prong (70-6) of the inserter holds the implant (60) in an inner row position at the surgical site (105). A set of two inner suture tails (107-3, 107-4) are retrieved through the auxiliary portal (301) and tied to establish inner fixation with an inner stitch / knot (303). The inserter (70) can preferably be removed (e.g., by releasing the outer and retaining sutures / threads (80) from the inserter as shown in FIG. 45). This step can be repeated for other inner sutures (107-1 and 107-2) before or after removing the delivery device.

[0047] In FIG. 45, the threads (80) connected to the handle (50) are uncleated.

[0048] As shown in FIG. 46, after the threads (80) were released from the cleat, the inserter (70) was removed from the surgical site (105) and the cannula (101).

[0049] Returning to FIG. 47a, two medial suture tails (107-1, 107-2) of the second set are retrieved through the auxiliary portal (301) and tied with a medial stitch / knot (305) to establish additional medial fixation. However, the medial stitch / knot (305) is not required for successful use or to complete the procedure. Medical practitioners / surgeons may choose to fix these sutures in the lateral column without tying them medially. An example of the final structure in this case (a completed rotator cuff augmentation without medial knots) is shown in FIG. 47b. Returning to FIG. 47a, the retaining stitch (60-6) is removed from the implant (60), and any remaining knots are tied. To secure the lateral aspect of the rotator cuff to the attachment site, each lateral stitch (60-2) can be threaded and secured into each lateral column knotless anchor (307) (optional, together with the medial stitches as illustrated). Appropriate tension may be added to establish an even distribution of load. Pre-loaded lateral stitches are not explicitly required. Some surgeons may choose to remove pre-loaded lateral stitches by cutting them off before implantation. Exemplary fully developed end results according to specific techniques, such as double column fixation, single column fixation, or onlay fixation, may be obtained (as should be understood by those skilled in the art with a review of this disclosure).

[0050] The following drawings relate to alternative embodiments of an implant delivery device, which may include one or more additional or similar components (in structure and / or function) with some differences. Only major additional aspects and / or differences are highlighted and discussed below. Although various alternative embodiments are described herein, all embodiments and their parts may be combined in any mechanically possible manner, as should be understood by those skilled in the art in conjunction with a review of this disclosure.

[0051] In one alternative embodiment, the passer assembly may include a passer housing comprising passers (401), a passer block (403), a passer tab (405), a cannula-type insertion tube (70) having a handle (50'), and an implant (60), as shown in FIG. 48a. After suture tails from the surgical site are loaded into the passers (401), the passer tab (405) may be pulled away from other part(s) of the passer assembly and may have a similar function for suture tails pulled through the implant (60) as described above in relation to the first passer housing (30) moving proximally to the second passer housing (40) as shown in FIG. 48b.

[0052] Returning to FIG. 49, the implant is illustrated with medial suture passage positions (60-8), a retaining stitch (60-6), and a single tail mattress stitch (60-2). The foot (70-6) is also illustrated, which may be in line with the shaft or at an angle to it. For example, a 15 to 25 degree bend (left, which was found to be the most helpful angle for achieving the function discussed herein), and a flat / linear / non-angled configuration are illustrated on the right.

[0053] Referring to FIGS. 50a and 50b, enlarged views of the upper and middle passage holes (40-2') and (40-4') are shown, along with a passage (60-4') positioned through the interior, according to an alternative embodiment. As illustrated, in this embodiment, the shape of the passages (60-4') and the slots within the passage holes (40-2') allow a user to load a suture (not shown) through the holes (40-2', 40-4') and pull the passages (60-4') forward from a first position (Fig. 50a) to a second position (Fig. 50b) to "clip" the suture in place, thereby preventing it from falling out while the remaining sutures are loaded into the device (10'). In this embodiment, passages (60-4') made of stainless steel (or other similar material) were found to be the most optimal.

[0054] Now, referring to FIG. 51, another alternative embodiment of the implant delivery system (10") is illustrated. In this embodiment, a different version of the first passer housing (30") is positioned on the second passer housing (40"), but functions similarly to the embodiments described above. A sliding mechanism (50-6") may be incorporated within the handle (50"), which can actuate the first / upper passer housing (30"). In some examples, the first passer housing (30") may instead be operated manually.

[0055] FIGS. 52a and 52b show perspective views of other alternative embodiments of the implant delivery system (10'''). In this embodiment, the first passer housing (30''') can be slidably mounted to the second passer housing (40''') and can function similarly to the first passer housing described above. As illustrated, the shapes of the first and second passer housings (30''') and (40''') may have concave sections and rivets to provide ergonomic support to the user.

[0056] FIGS. 53a through 53k illustrate additional alternative embodiments of the implant delivery system (10"). Referring to FIG. 53a, a perspective view of the implant delivery system (10") is shown. In this embodiment, the first passer housing (30") may include a locking mechanism (30-10") that allows the first passer housing (30") to be moved or separated from the second passer housing (40") (see FIG. 53e) and / or release a sliding mechanism (not shown). As shown in FIG. 53b, the sliding mechanism (90") may be slidably positioned between the first passer housing (30") and the second passer housing (40") to pull the passers (not shown) as described above (see FIG. 53b). As illustrated in FIG. 53c, an alternative twist tab (30-12"") may be provided to operate the locking mechanism (30-10"") from the locked position to the unlocked position. Referring to FIG. 53d, an enlarged perspective view of the second passer housing (40"") with the first passer housing and the cannula-type tube inserter removed is shown for exemplary purposes. As illustrated, the passers (60-4"") are positioned and function similarly to the embodiments described above. Referring to FIG. 53f, the twist tab (30-12"") is in an upright position relative to the first and second passer housings (30"") and (40""), and the locking mechanism (30-10"") is in the unlocked position (compared to the locked position illustrated in FIG. 53c).

[0057] Now, referring to FIG. 53h, a block mechanism (92") is shown coupled to a second passer housing (40"). In this example, the inner sutures (60-8") are coupled to the block mechanism (92") and extend from it, allowing the device to function similarly to the embodiments described above. The block mechanism (92") can move and pivot relative to the second passer housing (40") and may include, as an example, six inner sutures (60-8").

[0058] Now, referring to FIG. 53i, a perspective view of a second passer housing (40"") with the first passer housing removed for exemplary purposes is shown. In this example, the disc (30-14"") may be rotatably coupled to be fitted into the second passer housing (40"") to retain the inserter tube while it is in the unextended position and to release the inserter tube in the unfolded position. The path of the grooves within the block mechanism (92"") controls the rotation of the disc (30-14"") so that the disc does not rotate and does not release the shaft until the passers have completely passed through the implant. In other words, the user can rotate (30-10""), which is configured to push (92"") and the attached passers backward through the implant. When the passers pass through the implant, an additional rotation of (30-10"") pushes (92""), causing the geometry within (92"") and (30-14"") to rotate (30-14"") to release the shaft. Similar to the embodiments described above, the disc (30-14"") may include openings on both sides through which a cannular tube inserter (not shown) can pass and extend (see FIG. 53k). Referring to FIG. 53j, an example of a locking mechanism (30-10"") having a piece formed integrally with the locking mechanism (30-10"") without a separate twist tab is shown.

[0059] FIGS. 54a through 55 refer to other alternative embodiments of an implant delivery system (10""') designed to support the hydration of an implant (60""') with biological fluids, including but not limited to blood, bone marrow aspirate, platelet-rich plasma, or cells from the same or different donors (as should be understood by those skilled in the art with a review of the present disclosure). This can guide an immune response within the patient and promote faster healing and tissue regeneration (as should be understood by those skilled in the art with a review of the present disclosure).

[0060] In this embodiment, the back plate of the implant delivery system (10""') is open to allow sufficient access to the entire implant (60""'), including all four edges, and is tray-shaped so that the surgeon can apply biological agents to be absorbed by the implant (60""'). In some cases where the biological agent cannot be maintained in an absorbed state within the implant (60""') while being inserted along the cannula (not shown), the embodiments illustrated in FIGS. 54a through 55 allow the biological agent to be applied under an arthroscope. These embodiments function and are structured similarly to the embodiments described above, except that the delivery of the biological agent is realized by a second tube or multi-lumen shaft (72""') positioned below or adjacent to the implant (60""') (and cannula-type tube inserter) and connected to the implant (60""') by a retaining stitch (not shown). In this example, the multi-lumen shaft (72""') may have a flexible area (74""') located near or adjacent to the implant (60""'), and the multi-lumen shaft (72""') may deposit biological material into and / or down the implant (60""'). The biological fluid may enter the multi-lumen shaft (72""') through a port (52""') located on the rear of the implant delivery system (10""') to which a syringe or other device for pushing out the biological agent is connected to the port (52""'). In some embodiments, as shown in FIG. 55, the handle (50""') may be configured to function as a syringe or similar device (54""') to push the biological agent into and / or down the implant (60""') through the multi-lumen shaft (72""'). In some embodiments, when the retaining stitch is removed, both ends of the implant (60""') and the multi-lumen shaft (72""') can be released.The multi-lumen shaft (72""') may remain connected to the rest of the implant delivery system (10""') and may be removed from the implant site along with the rest of the implant delivery system (10""'), leaving only the implant (60""'), sutures (not shown), and biological agent. In some examples, the multi-lumen shaft (72""') may be located within or formed integrally with a cannula-type tube inserter (not shown).

[0061] Returning to FIG. 56, an alternative embodiment of an implant delivery system is illustrated, comprising passages (60-15) (lateral passages) for loading sutures through the outer edge of the implant (60) without the outer stitches coming pre-loaded. In use, the sutures loaded into the outer edge of the implant will come from suture anchors inserted into the outer aspect for rotator cuff repair.

[0062] Referring to FIG. 57, an alternative embodiment of an implant delivery system is illustrated having passages (60-4') configured to pull the suture through the inner row (60-17), across the implant, and then through the outer row (60-19), without pre-loaded outer stitches.

[0063] Referring to FIG. 58, an alternative embodiment of an implant delivery system having separate inner passages (60-4) and outer passages (60-4-1) is illustrated to achieve the same result as illustrated and discussed in relation to FIG. 57. The implant (60) is illustrated as translucent with a two-stage passage system (60-4 and 60-4-1). In use, the four inner passages (60-4) are configured to pull sutures through the inner holes of the implant into the eyelets of each outer passage (60-4-1). The outer passages (60-4-1) are configured to have a delay by being longer than the inner passages (60-4) to ensure that the inner passages (60-4) are pulled first. Subsequently, when the housing / slide connected to all the passers is pulled in a single motion (as discussed herein), the outer passers (60-4-1) are pulled to pull the sutures through the outer holes of the implant. In other words, the outer passers (60-4-1) are longer so that when the slide connected to all the passers is pulled in a single motion, the inner passers (60-4) pull the sutures through the implant (60) and the outer passers (60-4-1) before the outer sutures combine with the material within the eyelets of the passers. Alternatively, the inner and outer passers may be on separate parts of the housing / slide that are movable and can be operated individually by the user.

[0064] Returning to FIGS. 59 through 62, various views of alternative embodiments of the implant delivery system are illustrated. Since sutures (not illustrated) pulled through the outer row (60-19) are pulled away from the back plate surface (40-8), the implant (60) can be supported by a sliding retaining component (60-21) having an outer edge support. FIG. 59 shows a sliding retaining component (60-21) in a closed position with a support for the outer edge of the implant and locked into the insertion tube at 60-21-1. FIG. 60 shows a catch (60-21-3) configured to move the sliding retaining component (60-21) to be released from the insertion tube by swinging or sliding in a distal direction (or proximal direction in other embodiments). FIG. 61 shows a first / upper passer housing (30-1) slidably coupled to a second passer housing (40-1) in a manner similar to other embodiments of the first passer housing. The first passer housing (30-1) is pulled / slid proximally to its unfolded state to push the catch (60-21-3) back to release the sliding retaining component (60-21) from the inserter tube. FIG. 62 shows the sliding retaining component (outer support feature) (60-21) in its unfolded state, released from the implant (60). FIG. 62 also shows the catch or locking part (60-21-1) released by elastically opening the inserter tube, and the first passer housing (30-1) in its unfolded state, slid proximally on the second passer housing (40-1).

[0065] Although embodiments of the present disclosure have been specifically shown and described with reference to specific exemplary embodiments, it will be understood by those skilled in the art that various modifications of the details may be made within the embodiments without departing from the spirit and scope of the features of the invention as defined by the claims supported by the written description and drawings. Furthermore, where exemplary embodiments are described with reference to a specific number of elements, it will be understood that the exemplary embodiments may be practiced using fewer or more elements than the specific number.

[0066] Although various embodiments have been described and illustrated in this specification, those skilled in the art will readily conceive of various other means and / or structures for performing functions and / or obtaining results and / or obtaining one or more of the advantages described in this specification, and each such variation and / or modification is deemed to be within the scope of the embodiments described in this specification. More generally, those skilled in the art will readily recognize that all parameters, dimensions, materials, and configurations described in this specification are exemplary and that actual parameters, dimensions, materials, and / or configurations will depend on the specific application or application in which the teaching(s) of the present invention are used. Those skilled in the art will be able to recognize or identify many equivalents of the specific embodiments described in this specification using only routine experimentation. Accordingly, the foregoing embodiments are presented merely as examples, and it should be understood that within the scope of the appended claims and their equivalents, embodiments may be practiced differently from those specifically described and claimed. The embodiments of this disclosure relate to each individual feature, system, article, material, kit, and / or method described in this specification. Additionally, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of this disclosure, provided that such features, systems, articles, materials, kits, and / or methods are not contradictory.

[0067] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the features of the invention of the embodiments. As used herein, the singular forms “A,” “An,” and “The” are intended to include plural forms unless the context clearly indicates otherwise. It will be further understood that the terms “include” (and any form of “include”, e.g., “includes” and “includes”), “have” (and any form of “have”, e.g., “has”) and “has”), “include” (and any form of “include”, e.g., “includes”) and “includes”), and “contain” (and any form of “contains”, e.g., “contains”) are open linking verbs. Consequently, a method or apparatus that “includes,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of an element of a device or method that "includes," "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. Additionally, a device or structure configured in a particular manner may be configured at least in that manner but may also be configured in unlisted manners.

[0068] The corresponding structures, materials, actions, and equivalents of all means or step plus function elements in the following claims are intended to include any structure, material, or action to perform a function in combination with other claimed elements, if any, specifically claimed. The descriptions of the embodiments are presented for illustrative and descriptive purposes but are not intended to be limited to the features of the invention in the embodiments as disclosed or in their entirety. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the features of the invention in the embodiments. The embodiments have been selected and described to best illustrate the principles and practical applications of one or more aspects of the features of the invention and to enable other people skilled in the art to best understand the features of the invention in various embodiments having various modifications suitable for the specific use considered.

Claims

Claim 1 A bioinductive implant delivery system comprising: a bioinductive implant having at least a first aperture through which an opening portion of a first passage is positioned in a predeployment configuration and through which a first suture is positioned in a ready-to-be-deployed configuration; and a delivery mechanism 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 the distal end of the shaft, wherein the bioinductive implant is connected to the distal foot portion. Claim 2 An implant delivery system according to claim 1, further comprising a pass-through housing through which the shaft passes. Claim 3 In paragraph 2, the above housing comprises a first pass-through housing and a second pass-through housing, an implant delivery system. Claim 4 An implant delivery system according to paragraph 3, wherein the first pass-through housing is slidably coupled to the second pass-through housing and configured to move the implant from a first position to a second position to change the implant from the un-deployed configuration to the deployed configuration. Claim 5 An implant delivery system according to claim 4, wherein when the first pass-through housing moves from the first position to the second position, the first pass-through housing is configured to move a portion of the first suture through the implant. Claim 6 An implant delivery system according to claim 5, further comprising a handle portion attached to the proximal end of the shaft, wherein the handle portion is attached to the housing. Claim 7 An implant delivery system according to claim 6, wherein the first pass-through housing and the second housing are configured to be removed from the shaft and the handle portion when the first pass-through housing is in the second position. Claim 8 In paragraph 3, the implant delivery system comprises a second pass-through device including a surface on the distal end where the implant is located in the undeveloped configuration. Claim 9 In paragraph 3, the implant delivery system wherein the second pass-through housing includes an opening in which the opening portion of the first pass-through is located. Claim 10 An implant delivery system according to paragraph 3, wherein the second pass-through housing includes a surface to prevent the first pass-through housing from sliding distally beyond a specific predetermined position. Claim 11 An implant delivery system according to paragraph 3, wherein the second pass-through housing includes a surface to prevent the first pass-through housing from sliding proximally beyond a specific predetermined position. Claim 12 An implant delivery system according to claim 1, wherein the shaft is cannulated. Claim 13 In claim 12, the implant delivery system comprises at least one retaining suture positioned through the implant. Claim 14 In claim 13, the implant delivery system wherein at least one retention suture extends through the cannula-shaped shaft. Claim 15 A method for delivering a bio-induced implant comprising: a bio-induced implant having at least a first aperture; a delivery mechanism having a shaft and a distal foot portion attached to the shaft, wherein the bio-induced implant is connected to the distal foot portion; and a bio-induced implant delivery system comprising a first passer positioned through the at least first aperture; a step of capturing a first suture extending from a repair site through the first passer; a step of pulling the first suture through the first aperture; a step of forming a knot with the first suture at the repair site; and a step of removing the delivery mechanism from the repair site.

Images