Implant Delivery Device

Abstract

An implant delivery device may include an implant holding portion near the distal end, the implant holding portion configured to receive the implant during implantation of the sheet-shaped implant. Additionally, the implant holding portion may be configured to receive the implant using a fixed implant support flange member and a movable implant support flange member configured to support the implant on one side. The movable implant support flange member may be configured to be slidable between a distal position and a proximal position, wherein, in the distal position, the movable implant support flange member fixes the implant on the fixed implant support flange member, and in the proximal position, the movable implant support flange member is withdrawn from the distal end of the implant delivery device so as to be able to release the implant.

Description

[0001] Citation of Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 972,775, filed on Feb. 11, 2020, entitled “Graft Delivery Device”, the entire disclosure of which is incorporated herein by reference. Background Art

[0003] Embodiments of the present disclosure generally relate to medical devices, and more particularly, to a medical device for repairing tissue.

[0004] Rotator cuff repair is a surgical procedure for repairing torn (or partially torn) tendons in the shoulder. The procedure can be performed using a large incision or arthroscopic techniques. To repair a torn tendon (e.g., the supraspinatus tendon), a surgeon can use an anchor and suture to reattach the tendon to the humerus. A graft is then used to cover the repair area to promote healing. It is difficult to insert a graft through a small incision and place it in the desired position using arthroscopic surgery.

[0005] There is a need in the art for a system and method that overcomes the above disadvantages. Summary of the Invention

[0006] In one aspect, the present disclosure relates to an implant delivery device that includes a handle disposed at a proximal end of the implant delivery device and configured to be grasped by a user. The device may also include an outer shaft extending from the handle to a distal end of the implant delivery device. Additionally, the implant delivery device may include an implant holding portion near the distal end of the implant delivery device, the implant holding portion being configured to hold the implant during implantation of a sheet-like implant. Further, the implant holding portion may be configured to receive the implant between a fixed implant support flange member configured to support the implant on one side and a movable implant support flange member. The movable implant support flange member may be configured to be slidable between a first distal position and a second proximal position. In the first distal position, the movable implant support flange member fixes the implant to the fixed implant support flange member, thereby holding the implant in a deployed configuration. In the second proximal position, the movable implant support flange member is withdrawn from the distal end of the implant delivery device, thereby enabling release of the implant.

[0007] In another aspect, the present disclosure relates to an implant delivery device that includes an implant retention portion near a distal end of the implant delivery device, the implant retention portion configured to retain an implant during implantation of a sheet implant. The implant retention portion may be configured to receive the implant using a movable implant support flange member configured to retain the implant. The movable implant support flange member may be configured to be movable between a first position and a second position, in the first position, the movable implant support flange member holds the implant within a recess, and in the second position, the implant is unobstructed by the movable implant support flange member, such that the implant can be released from the implant retention portion of the implant delivery device.

[0008] In another aspect, the present disclosure relates to a method of delivering a sheet implant to a surgical site. The method may include providing an implant delivery device with a sheet implant, the sheet implant being secured by an implant retention portion of the implant delivery device such that the implant is held relative to an outer shaft between a fixed implant support flange member and a movable implant support flange member. The method may further include inserting the implant retention portion of the implant delivery device into the surgical site. Additionally, the method may include moving the movable implant support flange member to the second position, thereby allowing release of the implant.

[0009] By studying the following drawings and detailed description, other systems, methods, features, and advantages of these embodiments will be apparent or will become apparent to those of ordinary skill in the art. All such additional systems, methods, features, and advantages are included within this specification and the scope of the invention, are included within the scope of the embodiments, and are protected by the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Embodiments of the present disclosure are better understood by reference to the following drawings and description. The components in the drawings are not necessarily drawn to scale, and the emphasis is instead placed upon illustrating the principles of these embodiments. Additionally, in the drawings, the same reference numerals represent corresponding parts in all different views.

[0011] Figure 1 is a schematic view of a step in a surgery for repairing a rotator cuff tendon in one embodiment;

[0012] Figure 2 is a schematic view of a step of applying an implant to a portion of a rotator cuff tendon to promote healing in one embodiment;

[0013] Figure 3 is a schematic view of an implant delivery device in one embodiment that holds an implant prior to being delivered through the illustrated access cannula;

[0014] Figure 4 is an enlarged schematic view of the implant holding portion of an implant delivery device that holds an implant;

[0015] Figure 5 is another schematic view of an implant delivery device of an embodiment that holds an implant before being delivered through the illustrated access cannula;

[0016] Figures 6 - 7 is a schematic view showing an implant being inserted through a cannula;

[0017] Figure 8 is a schematic view of an implant being rolled up during delivery through a cannula, but the cannula is removed for purposes of illustration;

[0018] Figure 9 is a schematic view of an implant delivery device extending through a cannula, where a cannula seal is located within the cannula and the implant unfolds after exiting the cannula;

[0019] Figure 10 is a schematic view of an implant delivery device where an implant support flange member is partially withdrawn during release of the implant;

[0020] Figure 11 is an enlarged schematic view of the implant holding portion of an implant delivery device where the implant support flange member is partially withdrawn, as Figure 10 shown;

[0021] Figure 12 is another enlarged schematic view of the implant holding portion of an implant delivery device where the implant support flange member is partially withdrawn;

[0022] Figure 13 is another enlarged schematic view of the implant holding portion of an implant delivery device where the implant support flange member is partially withdrawn and the implant is shown in dashed lines to show a second implant support member beneath the implant;

[0023] Figure 14 is an enlarged schematic view of the implant holding portion of an implant delivery device where the implant support flange member is partially withdrawn and the implant is omitted to show the relationship between two implant support flange members;

[0024] Figure 15 is a schematic view of an inner shaft and a movable implant support flange member held therein;

[0025] Figure 16 is a schematic view of the implant holding portion of an implant delivery device where the implant support flange member is fully withdrawn and the implant is released from the implant delivery device;

[0026] Figure 17 is a schematic view of an implant delivery device being withdrawn through a cannula after delivering an implant;

[0027] Figure 18 is a schematic view of a handle of an implant delivery device, with the outer panel removed to reveal the internal components of the handle;

[0028] Figure 19 is a schematic view of an implant delivery device being withdrawn through a cannula, where the cannula is shown in dashed lines to reveal a ring on the outer shaft of the implant delivery device pulling the cannula seal out of the cannula; and

[0029] Figure 20 is a flowchart showing a method of delivering a sheet implant to a surgical site using the implant delivery device shown and described with reference to Figures 3 - 19 shown and discussed. DETAILED DESCRIPTION

[0030] For clarity, the description herein refers to distal and proximal directions (or portions). As used herein, the term "distal" shall refer to the direction or portion that is oriented or positioned away from the user holding the implant delivery device (i.e., away from the surgeon using the device and toward the patient into whom the device is inserted). The term "proximal" refers to the direction or portion that is toward or located at the user holding the implant delivery device (i.e., toward the surgeon using the device and away from the patient into whom the device is inserted).

[0031] In addition, as used herein, the term "fixedly attached" refers to two components being joined in a manner that is not easily separable (e.g., without breaking one or both of the components). The term "removably attached" refers to components being attached to each other in a manner that is easily separable (e.g., attached with fasteners such as bolts, screws, etc.).

[0032] Figure 1 is a schematic view showing a surgical procedure for repairing a tendon of a patient's shoulder. Specifically, patient 100 is undergoing an arthroscopic procedure performed by surgeon 102. An enlarged view of a portion of the humerus 110 and the rotator cuff tendon 112 is also shown in Figure 1 . In this example, surgeon 102 has recently applied an anchor and suture to fix the supraspinatus tendon 114 to the humerus 110.

[0033] When the tendon has been adequately repaired and / or the surgical site otherwise prepared, surgeon 102 may insert an implant such as a graft (possibly using another device to facilitate insertion) through an incision. The graft may then be placed on a portion of the tendon and / or underlying bone to promote healing. As an example, Figure 2 shows a schematic view of a graft 202 being applied to a portion of the tendon 114 and the humerus 110.

[0034] Although the exemplary embodiments illustrate a procedure in which a tendon is first fixed to a bone using sutures and anchors, in other embodiments, a graft may be applied to one or more tendons without first reattaching the tendon. For example, the graft may be applied to a tendon that is only partially torn.

[0035] After the graft 202 is placed on the tendon, one or more sutures or one or more anchors are required to hold the graft 202 in place. The present embodiment discloses a graft delivery device configured to hold an implant such as a graft during insertion and release the implant / graft after the implant / graft is fixed at the surgical site.

[0036] Figures 3 - 19 An embodiment of an implant delivery device is shown that can be used to insert an implant through a small incision and place it on tissue in a fully opened state.

[0037] The implant delivery device may include means for biasing a sheet implant into an opened deployed configuration and means for releasing the implant when the implant is placed in a desired position. The handle includes means for driving the components of the implant holding portion of the means. It should be understood that the disclosed implant delivery device may be configured to deliver any type of sheet implant. For example, in some embodiments, the delivery device may be used to deliver a sheet graft. In some embodiments, the graft may be formed at least in part from collagen. In other embodiments, the sheet implant may be formed from a synthetic material or a mixture of collagen and various synthetic polymers, e.g., as described in U.S. Patent No. 10,617,787 to Francis et al. titled "Biopolymer Compositions, Scaffolds, and Devices" issued on April 14, 2020, and U.S. Patent No. 10,653,817 to Francis et al. titled "Methods of Generating Implantable Ligaments and Tendon Repair Devices" issued on May 19, 2020, the entire disclosures of which are incorporated herein by reference.

[0038] The handle includes a sliding member coupled to a component that facilitates release of the implant when the implant is placed in a desired position within the patient. The sliding member and associated components will be described and shown in further detail below.

[0039] The deployment device can be designed to be easy to hold. To this end, the body can include a grip portion. The grip portion can be designed to accommodate either the left or right hand. The user's hand can hold the grip portion and use their fingers to drive the sliding member. Additionally, the user can move the sliding member using one or more fingers or the thumb. It is understood that in some embodiments, a variety of different materials, coatings, and / or surface treatments can be used for the handle and / or the sliding member to improve the grip and prevent slipping.

[0040] In some embodiments, the disclosed implant delivery device can be configured to be inserted through a medical cannula. Medical cannulas are well known in the field of arthroscopic surgery. For example, various types of cannulas are used to control the inflow or outflow of fluid to allow tools to access tissue and for other functions. In certain types of surgical procedures, an implant or other matrix material can be introduced through the cannula into the surgical site, which maintains an enlarged access to the surgical site. Additionally, many arthroscopic surgeries (such as joint surgeries) use pressurized irrigation fluid to keep tissues separated from other tissues. In particular, the pressurized irrigation fluid can be used to aid visualization of the surgical site and prevent bleeding of the vasculature around the surgical incision. Other types of surgeries (such as gastrointestinal surgeries) use pressurized gas to provide access to the surgical site and visualization of the surgical site.

[0041] Using a cannula eliminates the need for an outer sheath that covers the implant during insertion. That is, if the implant is inserted through an incision in the patient's bare skin, the generally more fragile implant is typically preferably wrapped. Thus, an implant delivery device configured to directly introduce the implant through the skin (i.e., without a cannula) typically includes a sheath that covers the implant during insertion and then retracts to expose the implant when the distal end of the instrument reaches the surgical site. Alternatively, the device can include a fixed outer sheath and a movable internal component that holds the implant within the sheath during insertion and then moves distally to expose the implant at the surgical site.

[0042] The disclosed implant delivery device does not have a sheath that covers the implant. Instead, the disclosed device includes an elastic implant support flange member that clamps the implant generally along the midline of the implant. The flange member abuts partial regions on both sides of the implant. Thus, the elastic flange member biases the implant towards the deployed configuration. However, since both the implant and the flange member are flexible, the implant (and the flange member) may roll up when being delivered through a surgical cannula. When the distal end of the device exits the distal end of the cannula, the flange member biases the implant into the deployed state. The implant can then be placed on a tendon and / or bone at the surgical site. Additionally, the implant delivery device can be used to hold the implant in place while anchors are used to fix the implant to native tissue / bone.

[0043] Figure 3 is a schematic view of an implant delivery device of an embodiment that holds an implant before being delivered through the illustrated access cannula. As Figure 3 shown, the implant delivery device 300 can be configured to be inserted through the cannula 305. As Figure 3 further shown, the implant delivery device 300 can have a proximal end 310 and a distal end 315. Additionally, the implant delivery device 300 can include a handle 320 disposed at the proximal end 310 of the implant delivery device 300 and configured to be grasped by a user.

[0044] The implant delivery device 300 can include an implant holding portion 325 near the distal end 315 of the implant delivery device 300, and the implant holding portion 325 is configured to hold the implant 330 during the implantation of the sheet implant 330.

[0045] The handle 320 can include a housing 335, and the housing 335 includes a sliding member 340 configured to drive an implant release mechanism discussed in more detail below. In some embodiments, the handle 320 can include a two-handed universal configuration. For example, as Figure 3 shown, the slider member 340 can include a first slider 342 and a second slider 345. As shown in the subsequent figures (e.g., see Figure 18 ), the first slider 342 can be attached to or integrally formed with the second slider 345. Thus, driving either slider will produce the same effect. Therefore, a surgeon can hold the device in various orientations with either hand and still easily operate the sliding member 340.

[0046] The housing 335 of the handle 320 can be formed of a substantially rigid material, such as hard / rigid plastic and / or metal. The housing 335 must substantially maintain its shape and structural integrity during the manipulation of the implant delivery device 300 because the handle 320 is the part of the device where forces are applied during use. Additionally, the connection between the handle 320 and the outer shaft 390 must be configured to withstand such loads.

[0047] As Figure 3 shown, an exemplary cannula 305 can have a proximal end 350 with a wider opening and a narrower distal portion 355 including threads 360. The cannula 305 can include a tapered intermediate portion 365 between the proximal end 350 and the distal end 355. The implant delivery device 300 can be configured such that the tapered intermediate portion 365 can roll up the implant 330 as the implant 330 passes through the cannula 305. As Figure 3Further shown, cannula 305 may include a seal structure 370. The seal structure may include a seal 375. The seal 375 may be any type of seal suitable for the passage of an instrument, such as an obturator. For example, as shown in the drawings, the seal 375 may be a duckbill valve. In other embodiments, the seal 375 may be a tricuspid valve. In some embodiments, the seal structure 370 may include more than one seal in series. Additionally, the seal structure 370 may include a tether 380 for attaching the seal structure 370 to the cannula 305. Additionally, the seal structure 370 may include a grasping tab 385. It should be understood that the cannula 305 and the seal structure 370 may have any suitable configuration for passing an implant therethrough using the implant delivery device 300. The implant delivery device 300 may be configured to be used in conjunction with a cannula having any of the features disclosed in U.S. Patent Application No. 17 / 173,531, filed on February 11, 2021, by Jones et al. and titled "Surgical Cannula with Removable Pressure Seal", the entire disclosure of which is incorporated herein by reference.

[0048] Additionally, the implant delivery device 300 may include an outer shaft 390 extending from the handle 320 to the distal end 315 of the implant delivery device 300. The outer shaft 390 may be formed of a substantially rigid and biocompatible material. For example, the outer shaft 390 may be made of surgical stainless steel or titanium. In some embodiments, the outer shaft 390 may be formed to be substantially non - deflectable when subjected to implant delivery forces. In other embodiments, the outer shaft 390 may be configured to have a predetermined amount of flexibility to facilitate placement of the implant by manipulation of the handle. It should be understood that configurations are also contemplated where the implant does not necessarily have to be attached to the shaft but rather to an alternative structure at the distal end of the device.

[0049] Additionally, as Figure 3 shown, the implant delivery device 300 may further include a cannula seal 400 disposed about a middle portion of the outer shaft 390. The cannula seal 400 may include a proximal flange 405 for abutting the proximal end 350 of the cannula 305. Additionally, the cannula seal 400 may include a narrower distal portion 410 configured to fit within the narrower distal portion 355 of the cannula 305. The distal portion 410 of the cannula seal 400 may include one or more ribs 415 configured to seal the inner wall of the distal portion 355 of the cannula 305. Additionally, the cannula seal 400 may include a tapered intermediate portion 420 between the proximal flange 405 and the narrower distal portion 410.

[0050] When preparing to insert the implant into the device 300 through the cannula 305, the sealing structure 370 can be removed from the proximal end 350 of the cannula 305. To maintain pressure at the surgical site, the cannula seal 400 can be inserted into the cannula 305 when the implant delivery device 300 is passed through the cannula 305. The cannula seal 400 can slide along the outer shaft 390 of the implant delivery device 300 to facilitate maneuvering the implant delivery device 300 to the surgical site and around the surgical site.

[0051] Also as Figure 3 shown, the outer shaft 390 of the implant delivery device 300 can include a ring 425 that is disposed distally of the cannula seal 400 and configured to pull the cannula seal 400 out of the cannula 305 when the handle 320 of the implant delivery device 300 is pulled in the proximal direction to withdraw the implant delivery device 300 from the surgical site.

[0052] Figure 4 is an enlarged schematic view of the implant holding portion of the implant delivery device that holds the implant. Specifically, as Figure 4 shown, the implant holding portion 325 can include a recess 450 configured to receive the implant 330, a fixed implant support flange member 435 disposed within the recess 450 and configured to support the implant 330 on one side, and a movable implant support flange member 440. The fixed implant support flange member 435 can be fixedly attached to the outer shaft 390 within the recess 450. The movable implant support flange member 440 can be configured to slide between a first distal position and a second proximal position. In the first distal position, the movable implant support flange member 440 is disposed within the recess 450 and secures the implant 330 to the fixed implant support flange member 435, thereby holding the implant 330 in the deployed configuration within the recess 450, as Figure 4 shown. It should be noted that although the flange members are not as large as the implant, the partial support provided by the smaller flange members is sufficient to hold the implant in a substantially deployed state. The hardness and / or size of the flange members can vary depending on the type of implant to be used with the device and the relative stiffness of the implant. Additionally, the distance between the flange members can vary depending on the thickness of the implant and the relative compressibility of the implant to ensure an appropriate clamping force between the flange members.

[0053] The fixed implant support flange member 435 and the movable implant support flange member 440 can be formed of a soft but elastic material. That is, the material can be bent relatively easily but will return to a flat configuration when the load is removed.

[0054] In addition, since the fixed implant support flange member 435 and the movable implant support flange member 440 are exposed to the surgical site, they can be formed of biocompatible materials. Such biocompatible plastics can include the following materials: polyethylene, polypropylene, polyimide acrylonitrile butadiene styrene, and PAEK polymers. In some embodiments, the implant support flange member formed of such materials can have a thickness of approximately 0.001 to 0.025 inches. Other possible materials for the flange member can include nitinol, stainless steel, and / or titanium. The implant support flange member formed of such metallic materials can be formed to an appropriate thickness to match the characteristics of the flange member formed of the above non-metallic materials.

[0055] Also as Figure 4 shown, the movable implant support flange member 440 can be attached to the inner shaft 430, and the inner shaft 430 can be translated in the proximal direction and the distal direction to slide the movable implant support flange member 440. In addition, the distal end 315 of the implant delivery device 300 can include a recess 445 located at the end of the outer shaft 390 for receiving the distal end of the inner shaft 430. Since at least a portion of the inner shaft 430 is exposed to the surgical site, the inner shaft 430 can also be formed of a biocompatible material, such as surgical stainless steel or titanium.

[0056] In addition, also as Figure 4 shown, the distal wall 455 of the recess 450 can be beveled. This bevel can assist in the release of the implant 330 and in removing the implant delivery device 300 from the surgical site when the implant delivery device 300 is withdrawn over the implanted implant. That is, when removing the implant delivery device 300, the bevel of the distal wall 455 allows the outer shaft 390 to slide over the implant 330 without hooking the edge of the implant 330.

[0057] Figure 5 is another schematic view of the implant delivery device 300 holding the implant 300 prior to delivery through the cannula 305. The panel 335 ( Figure 3 ) is removed in Figure 5 to expose the internal structure of the handle 320. The sliding member 340 can be configured to move in the proximal direction and the distal direction to move the movable implant support flange member 440 between the first distal position discussed above and shown in Figure 5 (and Figure 3 and Figure 4 ) and a second proximal position (shown in Figure 16 and discussed in further detail below), in the second proximal position, the movable implant support flange member 440 is disengaged from a recess in the outer shaft 390 (see Figure 4The recess 445 shown in is withdrawn so that the implant 330 can be released from the recess.

[0058] It should be understood that in some embodiments, the sliding of the movable implant support flange member can be reversed. That is, the movable flange member can slide in the distal direction to release the implant. In other embodiments, the movable implant support flange member can move in an alternative non-sliding manner to release the implant. For example, in some embodiments, the movable implant support flange member can move relative to the fixed implant support flange member in a clamshell action. In certain cases, the clamshell opening may occur at the proximal or distal end of the implant. In other cases, the clamshell opening can be on one side or the other side of the implant.

[0059] Figure 5 Also included is an enlarged view of the implant holding portion of the implant delivery device 300. In this view, Figure 5 the movable implant support flange member 440 is shown disposed against the implant 330, thereby preventing the implant 330 from being released. Figure 5 Also shown is the inner shaft 430 extending through the outer shaft 390 and connecting the sliding member 340 in the handle 320 to the movable implant support flange member 440 at the distal end of the implant delivery device 300.

[0060] Figures 6 - 7 is a schematic diagram showing the implant being inserted through the cannula. Figure 6 The cannula 305 is shown in dashed lines to reveal the implant holding portion of the implant delivery device 300 and the implant 330 passing through the cannula 305. As Figure 6 shown, and more clearly as Figure 7 shown, the implant 330 may be rolled up when passing through the cannula 305.

[0061] It should be understood that the fixed implant support flange member (435; Figure 4 ) and the movable implant support flange member (440; Figure 4 ) are soft and elastic so that the fixed implant support flange member and the movable implant support flange member can contract / deflect when being delivered through the cannula 305. In some cases, as Figure 7As shown, the flange member and the implant 330 can be rolled up to facilitate the passage of the implant 330 through the cannula 305 and provide protection for the implant 330 during passage. However, it should be understood that the implant and the flange member may fold, wrinkle, or otherwise contract in a uniform or non-uniform manner when inserted through the cannula. In other words, the implant and the flange member can have a constrained state or form and an unconstrained state or form, in which these elements are at least partially contracted in the constrained state or form and are substantially unfolded in the unconstrained state or form. When the surgeon passes the distal end of the delivery device with the implant through the cannula, a contracted / constrained state may occur in situ. This contracted / constrained state can be the "non-use" state of the implant, while the (substantially) unfolded state can be the "use" state.

[0062] Figure 8 is a schematic view of the implant being rolled up during delivery through the cannula, but the cannula is removed for purposes of illustration. As Figure 8 shown, not only does the implant 330 contract, but the fixed implant support flange member 435 also contracts with the implant 330. Of course, inside the contracted implant 330, the movable implant support flange member (440) is also contracted.

[0063] Figure 9 is a schematic view of an implant delivery device extending through the cannula, where a cannula seal is located within the cannula and the implant unfolds after emerging from the cannula. In particular, Figure 9 shows the implant holding portion 325 of the implant delivery device 300 extending to a position beyond the distal end of the cannula 305. Thus, the implant 330 unfolds at this position because the cannula no longer surrounds the implant 330 to keep it rolled up.

[0064] Figure 9 also shows the cannula seal 400 located within the cannula 305. In this configuration of the components, pressure can be maintained within the surgical site, and the implant is ready to be anchored to tissue / bone and then released from the implant holding portion 325 of the implant delivery device 300.

[0065] Figure 10 is a schematic view of the implant delivery device where the implant support flange member is partially withdrawn during the release of the implant. As Figure 10 shown, the sliding member 340 has moved proximally a portion of its allowable travel. Thus, the inner shaft 430 has moved proximally, causing the attached movable implant support flange member 440 to slide in the proximal direction. It should be noted that during this retraction phase, there does not necessarily have to be any stop device to prevent the mechanism. This is an intermediate state just to facilitate the demonstration of the process of withdrawing the movable implant support flange member 440.

[0066] Figure 11 is an enlarged schematic view of the implant holding portion of the implant delivery device, wherein the implant support flange member is partially retracted, as Figure 10 shown. As Figure 11 shown, the inner shaft 430 is partially retracted, and the movable implant support flange member 440 attached to the inner shaft is also partially retracted. In this state, the distal half of the implant 330 is no longer supported on both sides. This intermediate state is also shown only to illustrate the translation of the movable implant support flange member 440.

[0067] Figure 12 is another enlarged schematic view of the implant holding portion of the implant delivery device, wherein the implant support flange member is partially retracted. Figure 12 The recess 445 is shown, in which the distal end of the inner shaft 430 is disposed when the movable implant support flange member 440 is in the distal (i.e., implant holding) position.

[0068] Figure 13 is another enlarged schematic view of the implant holding portion of the implant delivery device, wherein the movable implant support flange member 440 is partially retracted, and the implant 330 is shown in dashed lines to show the fixed implant support member 435 under the implant 330. Figure 13 Shows how the fixed implant support flange member 435 is held in place and fixed to the outer shaft 390, and the movable implant support flange member 440 has moved proximally relative to the fixed implant support flange member 435.

[0069] Figure 14 is an enlarged schematic view of the implant holding portion of the implant delivery device, wherein the implant support flange member is partially retracted, and the implant is omitted to show the relationship between the two implant support flange members. Similarly, the fixed implant support flange member 435 is held in place at the distal end of the implant delivery device 300, and the movable implant support member 440 has moved proximally relative to the fixed implant support flange member 435 and the outer shaft 390. To facilitate this movement of the movable implant support flange member 440, the outer shaft 390 may include a slot 1400. As Figure 14 shown, the outer shaft 390 may include a slot 1400, into which the movable implant support flange member 440 slides when the inner shaft 430 moves in the proximal direction.

[0070] Figure 15 is a schematic view of the inner shaft and the movable implant support flange member held therein. As Figure 15As shown, the inner shaft 430 may include a slit 1500, and a movable implant support flange member 440 is disposed in the slit 1500. The movable implant support flange member 440 may be closely fitted within the slit 1500 such that when the inner shaft 430 is moved, the movable implant support flange member 440 moves. In addition, the distal end of the inner shaft 430 may include a beveled end 1505 to facilitate insertion of the distal end into a recess (445; Figure 4 ) at the distal end of the outer shaft 390.

[0071] To fully release the implant from the recess of the outer shaft, the inner shaft is further retracted so as to fully withdraw the movable implant support flange member from the recess. Figure 16 FIG. is a schematic view of the implant holding portion of the implant delivery device, where the implant support flange member is fully withdrawn and the implant is released from the implant delivery device. As Figure 16 shown, the movable implant support flange member 440 has been further moved proximally and no longer overlaps with the fixed implant support flange member 435. Accordingly, the implant 330 is released from the recess 450 in the outer shaft 390 of the implant delivery device 300.

[0072] Once the implant 330 is fixed at the surgical site and released, the implant delivery device 300 can be removed from the surgical site through the cannula 305. Figure 17 FIG. is a schematic view of the implant delivery device 300 being withdrawn through the cannula 305 after delivering the implant 330. Figure 17 Also shown is that the sliding member 340 in its most proximal position has slid proximally to fully retract the movable implant support flange member (440; Figure 16 ). In addition, Figure 17 also shown is the cannula seal 400 being partially withdrawn from the cannula 305.

[0073] Figure 18 FIG. is a schematic view of the handle of the implant delivery device with the outer panel removed to reveal the internal components of the handle. The purpose of including Figure 18 is to further show the details of the sliding member 340 and the attached inner shaft 430.

[0074] Figure 19 FIG. is a schematic view of the implant delivery device being withdrawn through the cannula, where the cannula is shown in dashed lines to reveal that a ring on the outer shaft of the implant delivery device pulls the cannula seal out of the cannula. As Figure 19As shown, the ring 425 on the outer shaft 390 abuts against the distal end of the cannula seal 400. Thus, due to the positioning of the ring 425, withdrawing the outer shaft 390 through the cannula 305 will cause the cannula seal 400 to disengage from the cannula, thereby allowing the complete removal of the implant delivery device 300 without the cannula seal 400 remaining stuck within the cannula 305 and slipping off the end of the outer shaft 390.

[0075] Figure 20 is a flow chart showing a method of delivering a sheet implant to a surgical site using the implant delivery device described with reference to Figures 3 - 19 shown and discussed. As Figure 20 shown, the method of delivering the implant may include inserting a cannula into an incision in the patient's skin (step 2000). In some embodiments, the method may include placing the sheet implant in the implant holding portion of the implant delivery device. However, in other embodiments, the process of loading the implant into the implant delivery device may be completed as a manufacturing step, and the loaded implant delivery device may be provided to the surgeon for use.

[0076] In addition, after inserting the cannula, the method may further include arthroscopically inserting the implant holding portion of the implant delivery device through the cannula to the surgical site (step 2005). It should be noted that, in certain cases, the implant delivery device may be used in non-arthroscopic (e.g., open) surgeries. It should also be noted that the disclosed implant delivery device does not necessarily have to be used in combination with a cannula (e.g., cannula 305). If the implant delivery device is used in an open surgery, then a cannula is not required.

[0077] The next step in the method involves fixing the implant to the tissue / bone at the surgical site, for example using one or more anchor pins (step 2010). After the implant is fixed, the movable implant support flange member can be moved to a proximal position (by moving the sliding member in the proximal direction), thereby allowing the implant to be released (step 2015). Finally, when the implant is released, the instrument (i.e., the implant delivery device) can be removed from the surgical site (step 2020).

[0078] Although various embodiments have been described, the description is exemplary rather than restrictive, and it will be apparent to those of ordinary skill in the art that within the scope of the disclosed embodiments, more embodiments and implementations are possible. Although many possible combinations of features are shown in the drawings and discussed in the detailed description, many other combinations of the disclosed features are also possible. Any feature or element of any embodiment can be used in combination with or substituted for any other feature or element in any other embodiment, unless specifically restricted. Additionally, unless otherwise stated, any step in a method or system function can occur in any relative order with respect to any other step described herein.

Claims

1. An implant delivery device, comprising: A handle disposed at the proximal end of the implant delivery device and configured to be grasped by a user; And An outer shaft extending from the handle to the distal end of the implant delivery device; The implant delivery device includes an implant holding portion near the distal end of the implant delivery device, the implant holding portion being configured to hold the implant during implantation of the sheet implant; and The implant holding portion is configured to receive the implant between a fixed implant support flange member associated with the outer shaft and configured to support the implant on one side and a movable implant support flange member; Wherein the movable implant support flange member is configured to be slidable between a first distal position and a second proximal position; Wherein, in the first distal position, the movable implant support flange member fixes the implant to the fixed implant support flange member, thereby holding the implant in a deployed configuration; and Wherein, in the second proximal position, the movable implant support flange member is withdrawn from the distal end of the implant delivery device, thereby enabling the release of the implant; Wherein the fixed implant support flange member and the movable implant support flange member are soft and elastic, such that when being delivered through a cannula, the fixed implant support flange member and the movable implant support flange member can contract.

2. The implant delivery device according to claim 1, further comprising a cannula seal disposed around a middle portion of the outer shaft.

3. The implant delivery device according to claim 2, wherein the outer shaft includes a ring disposed distally of the cannula seal and configured to pull the cannula seal out of the cannula when the handle of the implant delivery device is pulled in a proximal direction.

4. The implant delivery device according to claim 1, wherein the handle includes a sliding member configured to move in a proximal direction and a distal direction to slide a movable implant support flange member between a first position and a second position.

5. The implant delivery device according to claim 4, further comprising an inner shaft that extends through the outer shaft and connects a slider in the handle to the movable implant support flange member at a distal end of the implant delivery device.

6. The implant delivery device according to claim 5, wherein the inner shaft includes a slit, and the movable implant support flange member is disposed in the slit.

7. The implant delivery device according to claim 6, wherein the outer shaft includes a slot, and when the inner shaft moves in a proximal direction, the movable implant support flange member slides into the slot.

8. The implant delivery device according to claim 1, wherein the implant holding portion includes a recess configured to receive the implant, and a distal wall of the recess is beveled.

9. An implant delivery device, comprising: An implant holding portion near the distal end of the implant delivery device, the implant holding portion being configured to hold the implant during implantation of the sheet implant; The implant holding portion includes a recess, a fixed implant support flange member disposed within the recess and configured to support the implant on one side, and a movable implant support flange member configured to hold the implant; Wherein the movable implant support flange member is configured to be movable between a first position and a second position, in the first position, the movable implant support flange member holds the implant within the recess of the implant holding portion to receive the implant, in the second position, the implant is unobstructed by the movable implant support flange member, thereby enabling the release of the implant from the implant holding portion of the implant delivery device; Wherein the fixed implant support flange member and the movable implant support flange member are soft and elastic, such that when being delivered through a cannula, the fixed implant support flange member and the movable implant support flange member can at least partially contract.

10. The implant delivery device according to claim 9, wherein the implant is held in the recess by the movable implant support flange member and the fixed implant support flange member.

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