Instrumentation for obtaining perpendicular alignment on non-planar surfaces during orthopedic procedures

Abstract

In one embodiment, a sizing alignment tool for sizing a surgical device and for aligning one or more surgical tools relative to a surface during an orthopedic procedure is provided. The sizing alignment tool includes a hollow stem and a head having an underside and a plurality of feet located along a bottom edge of the head. The head extends radially outward from the hollow stem which is axially aligned with a center of the head.

Description

[0001] INSTRUMENTATION FOR OBTAINING PERPENDICULAR ALIGNMENT ON NON-PLANAR SURFACES DURING ORTHOPEDIC PROCEDURES

[0002] CROSS REFERENCE TO RELATED APPLICATIONS

[0003] The present application claims priority to and the benefit of US patent application Serial No. 63 / 674,919, filed July 24, 2024 and US patent application Serial No. 63 / 674,910, filed July 24, 2024, each of which is hereby expressly incorporated by reference in its entirety.

[0004] TECHNICAL HELD

[0005] The present technology is generally related to surgical tools and, more particularly to a tool and related method to size devices (e.g., osteochondral devices / implants) or grafts and align surgical tools relative to a surface during orthopedic procedures.

[0006] BACKGROUND

[0007] As discussed herein, the present disclosure is directed to instrumentation that is used for preparation of a focal defect. There are many different types of focal defects as mentioned herein. For example, focal defects are common injuries to adult cartilage. A focal articular cartilage defect means that there is damage to one specific area of the cartilage. A focal defect in the knee refers to an area of cartilage that was injured and has caused damage to what was once a normal joint surface. A focal articular cartilage defect can lead io knee pain, swelling and dysfunction.

[0008] Since cartilage is avascular, these injuries do not heal on their own, and surgical intervention is often necessary to treat focal cartilage defects in adults. These surgical procedures often include replacement of a layer of bone along with the cartilage using an osteochondral device, graft, or biologically based treatment.

[0009] Surgical preparation of the osteochondral site often involves drilling or coring of the cartilage and bone to prepare for replacement of the damaged cartilage and underlying bone. These surgical preparations result in the best possible function and longevity when the geometry of the implanted device or graft materials is aligned with the remaining native tissue.

[0010] After surgical preparation of the injury site to implant devices, osteochondral autografts, or osteochondral allografts, the devices or grafts should be positioned so that their peripheral surface is aligned with the surrounding cartilage to minimize stress discontinuities at the implant's boundary with the native cartilage. For devices or grafts that have peripheral geometry on a single plane, the alignment tool should allow for establishing and assessing how planar the corresponding surgical site is. For devices or grafts that have non-planar geometry, alignment tools should allow for establishing and assessing the deviation from planar geometry and insuring alignment of the devices or grafts with the prepared surgical site.

[0011] Current methods to size osteochondral devices or grafts and align surgical tools are either: (a) a wire with no additional alignment tools, or (b) alignment / sizing tools with a surface that is flat, tubular, or concave, having a continuous, planar, peripheral contact surface. These types of alignment tools contact the two highest points of the native surface and are unstable, rocking along a line connecting the two points of contact. They rely on user judgement to establish a plane corresponding to the periphery of the native surface and have no features for assessing how much the periphery of the native surface deviates from a single plane. After sizing, the site is prepared by forming an implant bed which determines the alignment of the implant (device) inserted into the prepared site.

[0012] Current instrumentation used for preparation of focal defect site for implant of a device, allograft, or autograft are either imprecise or do not allow for incremental adjustment of the alignment of the surgical site. It is therefore desirable to provide instrumentation that provides for the creation of an adjustable and precise implant bed for the placement of the implant (device).

[0013] SUMMARY OF THE DISCLOSURE

[0014] In one embodiment, a sizing alignment tool for sizing a surgical device and for aligning one or more surgical tools relative to a surface during an orthopedic procedure is provided. The sizing alignment tool includes a hollow stem and a head having an underside and a plurality of feet located along a bottom edge of the head. The head extends radially outward from the hollow stem which is axially aligned with a center of the head.

[0015] In another embodiment, a sizing alignment tool for sizing a surgical device and for aligning one or more surgical tools relative to a surface during an orthopedic procedure is provided. The sizing alignment tool includes a hollow stem and a head having an underside and a plurality of first feet located along a bottom edge of the head. The head extends radially outward from the hollow stem which is axially aligned with a center of the head. The tool also includes a hollow outer sheath that receives the hollow stem and has one or more second feet. The hollow outer sheath is coupled to the head such that the hollow outer sheath can moved relative to the head to allow a position of the one or more second feet relative to the plurality of first feet to be altered.

[0016] The present disclosure thus sets forth a single tool for both sizing and alignment. The tool has features that: (a) allow the user to select an appropriate implant size; (b) align the surgical preparation by establishing a plane normal to the periphery of the native tissue and (el) assess (three feet) deviation of the periphery from the established plane in the three feet embodiment, or (c2) measure deviation of the periphery from the established plane in the four feet embodiment.

[0017] The summary above is not intended to describe each illustrated embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these embodiments.

[0018] BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which:

[0020] Fig. 1 is a perspective view of a sizing alignment tool according to a first embodiment;

[0021] Fig. 2 is another perspective view thereof;

[0022] Fig. 3 is a top perspective view thereof;

[0023] Fig. 4 is an exploded perspective view thereof;

[0024] Fig. 5 is a side elevation view thereof;

[0025] Fig. 6 is a cross-sectional view taken along the line A-A of Fig. 5;

[0026] Fig. 7 is a perspective view of the sizing alignment tool that allows for visualization of damage and selection of correct sized replacement (implant) device / graft;

[0027] Fig. 8 is a perspective view of the sizing alignment tool configured to establish perpendicularity on a non-planar surface by placing all feet on the non-planar surface;

[0028] Fig. 9 is a side elevation view of an exemplary coring tool;

[0029] Fig. 10 is a side elevation view of the sizing alignment tool for use with the coring tool;

[0030] Fig. 11 is a side elevation view of the coring tool with the sizing alignment tool inserted therein;

[0031] Fig. 12 is a cross-sectional view taken along the line C-C of Fig. 11;

[0032] Fig. 13 is a perspective view of a sizing alignment tool according to a second embodiment; Fig. 14 is an exploded perspective view thereof;

[0033] Fig. 15 is a perspective view of the sizing alignment tool of Fig. 13 with movable feet not engaged with the non-planar surface;

[0034] Fig. 16 is a perspective view of the sizing alignment tool of Fig. 13 with the movable feet engaged with the surface to establish perpendicularity with the non-planar surface;

[0035] Fig. 17 is a side elevation view of an exemplary coring tool;

[0036] Fig. 18 is a side elevation view of the sizing alignment tool of Fig. 13 for use with the coring tool;

[0037] Fig. 19 is a side elevation view of the coring tool with the sizing alignment tool inserted therein;

[0038] Fig. 20 is a cross-sectional view taken along the line C-C of Fig. 19;

[0039] Fig. 21 is a side elevation view of the impaction tool with the implant (device) exploded; and

[0040] Fig. 22 is a cross-sectional view of the implant inserted into the local defect using the impaction tool.

[0041] While embodiments of the disclosure are amenable to various modifications and alternative forms, specifics thereof shown by way of example in the drawings will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

[0042] DETAILED DESCRIPTION

[0043] The present application discloses a single tool that is configured for both sizing the implant (device) and for aligning one or more surgical tools relative to a surface during orthopedic procedures. More specifically, the single tool has the following features: (a) allows the user to select an appropriate implant size; (b) align the surgical preparation by establishing a plane normal to the periphery of the native tissue; and (cl) assess deviation of the periphery from the established plane using a tool according to a first embodiment, or (c2) measure deviation of the periphery from the established plane using a tool according to a second embodiment. This tool can be referred to as be a sizing alignment tool or a sizer / aligner or sizing / aligning tool.

[0044] Each of the embodiments is described below. Definitions

[0045] The terms used in this specification generally have their ordinary meanings in the art, within the context of this invention and the specific context where each term is used. Certain terms are discussed below, or elsewhere in the specification, to provide additional guidance to the practitioner in describing the methods of the invention and how to use them. Moreover, it will be appreciated that the same thing can be said in more than one way. Consequently, alternative language and synonyms may be used for any one or more of the terms discussed herein, nor is any special significance to be placed upon whether or not a term is elaborated or discussed herein. Synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of the other synonyms. The use of examples anywhere in the specification, including examples of any terms discussed herein, is illustrative only, and in no way limits the scope and meaning of the invention or any exemplified term. Likewise, the invention is not limited to its preferred embodiments.

[0046] The terms “about” or “approximately” means within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined, i.e,, the limitations of the measurement system, i.e., the degree of precision required for a particular purpose, such as a pharmaceutical formulation. For example, “about” can mean within 1 or more than 1 standard deviations, per the practice in the art. Alternatively, “about” can mean a range of up to 20%, preferably up to 10%, more preferably up to 5%, and more preferably still up to 1% of a given value. Alternatively, particularly with respect to biological systems or processes, the term can mean within an order of magnitude, preferably within 5-fold, and more preferably within 2-fold, of a value. Where particular values are described in the application and claims, unless otherwise stated, the term “about” meaning within an acceptable error range for the particular value should be assumed.

[0047] The terms “implant”, “device”, and “construct”, are used interchangeably throughout this application and can mean any material inserted or grafted into the body. Biomedical uses of such implants, devices and constructs include but are not limited to drug delivery, biosensoring, repair and / or replacement of tissue, treating disease, defect and / or injury, and augmenting tissue function. Devices, constructs and materials may have applications outside of the biomedical field.

[0048] The term “defect” and the like refer to a flaw or a physical problem in a structure, or system, especially one that prevents it from functioning correctly, or a medical abnormality Defects can include, but are not limited to, wounds, ulcers, burns, natural defects, such as birth defects, and any other defects of biological tissue, including skin, bone, cartilage, muscle, tendon, ligament, meniscus, temporomandibular joint, arteries and blood vessels, and organs.

[0049] The term “biological tissue'’ as used herein includes but is not limited to musculoskeletal, including bone, tendon, ligaments, cartilage and the discs of the spine; vascular, including but not limited to, arteries, vessels, and heart valves; epidermal and dermal; connective tissue, including but not limited to, subcutaneous tissue; neurological and the associated dura tissue surrounding the brain and spinal cord; and dental.

[0050] The term “hydrogel” means a degradable or non-degradable natural or synthetic polymer network which is hydrophilic and can absorb a high amount of water. The hydrogel as used herein means any hydrogel that has mechanical properties that can be controlled separately by varying the polymer and water concentrations and / or the method of gelation such as freeze / thawing.

[0051] The term “biocompatible” as used in the application means capable of coexistence with living tissues or organisms without causing harm.

[0052] Implant

[0053] It will be appreciated that many different types of implants can be used with the instrumentation disclosed herein.

[0054] For example, the implant can be in the form of a multicomponent implant disclosed and claimed by Applicant in U.S. Pat. No. 9,545.310, which is hereby incorporated by reference in its entirety. This implant is for the treatment, repair or replacement of defects and injuries in biological tissue, especially musculoskeletal tissue. More particularly, the multi-component implant can comprise a solid hydrogel to resist load, a porous hydrogel layer to enable cellular infiltration and implant-tissue integration, and a porous rigid base to which the solid and porous hydrogels are both attached.

[0055] The shape and size of the implant is based at least in pail on the location of implantation and the local defect. In one embodiment, the implant can have a cylindrical shape.

[0056] The present instrumentation is described individually below; however, it will be appreciated that it can be provided together as pail of kit which can also include additional tools as well. Sizing Alignment Tool 100

[0057] Now referring to Figs. 1-6, a sizing alignment tool 100 according to a first embodiment is provided. The sizing alignment tool 100 has a first end 102 and an opposite second end 104. The sizing alignment tool 100 includes a stem 110 and a head 120. As described herein and as will be appreciated with reference to Fig. 4, the tool 100 can be of a modular nature in that the head 120 can be removed from the stem 110 to allow swapping of heads 120. When in modular form, the tool 100 can be part of kit in which a plurality of modular heads 120 are provided for determining the size of the defect. In one embodiment, the modular stem 110 is part of a 6 mm sizing alignment tool 100 which can be used as the stem for the large sizing / alignment heads.

[0058] Alternatively, the stem 110 and the head 120 can be a single part, with the head 120 not being removable from the stem 110. In this construction, the stem 110 and the head 120 are integral to one another.

[0059] The stem 110 is an elongated part and defines the first end 102 of the tool 100. The stem 110 is a tubular structure in that it includes an inner lumen or bore 105 that passes completely through the stem 110. The illustrated stem 110 has a cylindrical shape and the inner bore can have a circular shape.

[0060] The head 120 is the part of the tool 100 that functions as both the sizer and aligner. The head 120 has greater dimensions than the stem 110 and thus extends radially outward from the stem 1 10. The head 120 includes an upper section 122 that is adjacent the stem 110 and in the event of the modular version, the upper section 122 is the section that mates with the stem 110. The head 120 further includes a lower section 124 that extends radially outward from the upper section 122. The lower section 124 has an outer diameter and shape that matches the outer diameter and shape of the device (implant) 20. An underface or under-surface 125 of the lower section 124 is constructed to have a size and shape that matches the outer surface shape of the device 20 or graft.

[0061] The head 120 is preferably transparent in nature to allow for visualization of the native surface under the head 120 as well as around the head 120. For example, the head 120 can be formed of a clear polymer and therefore, when the user looks down at the tool 100, and the head 120 thereof, the transparent nature allows the user to directly observe the target site. In addition, the head 120, and in particular, the lower section 124, can include one or more windows 126. The windows 126 are formed in non-essential regions of the head 120. The presence of the windows 126 also allows visualization of the native surface under as w'ell as around the tool 100. The head 120 also includes a plurality of feet 130 that are formed along a bottom of the lower section 124 of the head 120. The feet 130 are located along the perimeter of the lower section 124 and are circumferentially spaced apart from one another. In the illustrated embodiment, there are three feet 130.

[0062] These three feet 130 on the bottom periphery of the sizing alignment tool 100 limit contact with the native surface to a single plane and allow the sizing alignment tool 100 to sit on the native surface in a stable manner. The three feet 130 can be symmetrically or asymmetrically spaced and / or sized. The height of the three feet 130 is selected to allow assessment of target device size in conjunction with planarity of the peripheral native tissue. For example, the sizing alignment tool 100 can be initially placed on the target site and peripheral gap between the tool 100 and native surface visually assessed. The feet 130 of the tool 100 can be rotated to locations with the largest gap and peripheral gap and or contact with the native tissue reassessed. If there is contact between the native tissue and the tool 100 such that a foot 130 is unsupported, the alignment tool size is likely too large, overhanging an inner or outer edge of the femoral condyle, and a smaller sized alignment tool should be evaluated. Height of the feet 130 determine the allowable variation in peripheral planarity. In one preferred embodiment, the height of the feet 130 range from 0.5 nun-2 mm.

[0063] In the modular embodiment, the stem 110 and head 120 detachably attach to one another using conventional techniques. As shown in Fig. 4, the stem 110 and head 120 can be attached using a taper lock 11 1 that is provided at the distal end of the stem 110. The taper lock 111 thus allows for a secure fit between the stem 110 and the head 120. Modular heads 120 can be manufactured to different diameters depending on the indication and treatment. In one exemplary embodiment, modular heads 120 ranging from 8 mm to 30 mm were designed for osteochondral defect repair.

[0064] As mentioned above, the sizing alignment tool 100 is cannulated for insertion of a pin (not shown) that can be fixed to the underlying bone and used to control location and orientation of instruments such as a scoring tool and drill / reamer to prepare the surgical site for the osteochondral device. The long handle, in the form of stem 110, allows for accurate control of the pin's angle relative to the native surface. The hole (bore) in the handle (stem 110) can be uniform in diameter throughout the entire length or a portion of the hole smaller in diameter to aid in controlling alignment of the pin. In one preferred embodiment, the smaller diameter portions of the hole, indicated at 129 in Fig. 6, are towards the tw'o ends and in the middle of the handle. Method of Use of Tool 100

[0065] Figs. 7-8 illustrate an exemplary method of use of the disclosed sizing alignment tool 100.

[0066] More specially. Figs. 7-8 illustrate a local defect in the form of a local defect 1 in cartilage 3.

[0067] Figs. 7-8 illustrate the use of the sizing alignment tool 100 that is placed over the local defect (damaged surface) 1. As mentioned, the sizing alignment tool 100 not only assists in determining the proper size of the implant that is to be installed but it also is used to establish perpendicularity on a non-planar surface by placing all feet 130 on the non-planar surface comprises the local defect 1 in cartilage 3. More specifically, the sizing alignment tool 100 is positioned over the local defect and in contact with the tissue such that all three feet 130 are in contact with the non-planar surface as shown in Fig. 8.

[0068] As shown in Fig. 7, the sizing alignment tool 100 allows for visualization of the damage (focal defect 1) and also guides the user in the selection of the correct sized replacement device / graft.

[0069] Once the sizing alignment tool 100 is placed in the desired position with all three feet 130 in contact with the non-planar surface, the stem 110 is thus position normal (perpendicular) to the non-planar surface. With the stern 110 being perpendicular to the non-planar surface, a pin that is delivered through the inner lumen of the stem 110 and is anchored within the tissue is likewise perpendicular to the non-planar surface. After the pin or the like is anchored in place, the sizing alignment tool 100 can be removed. The anchored pin can be used to guide a scoring tool and / or a drill / reamer or other tool .

[0070] Sizing Alignment Tool 200

[0071] Now referring to Figs. 13-16, a sizing alignment tool 200 according to a second embodiment is illustrated. The sizing alignment tool 200 has a first end 202 and an opposite second end 204. The main difference between the sizing alignment tool 200 and the sizing alignment tool 100 is that the sizing alignment tool 200 is of a four-footed design or of a design with more than four feet. Like elements between the two embodiments are numbered alike.

[0072] The sizing alignment tool 200 includes the stem 110 and a head 220, which can be of a modular design. As previously mentioned, the stem 110 is an elongated part and defines the first end 202 of the tool 200. The stem 110 is a tubular structure in that it includes an inner lumen or bore that passes completely through the stem 110. The illustrated stem 110 has a cylindrical shape and the inner bore can have a circular shape.

[0073] The head 220 is one part of the tool 200 that functions as both the sizer and aligner. The head 220 has greater dimensions than the stem 110 and thus extends radially outward from the stem 1 10. The head 220 includes an upper section 222 that is adjacent the stem 110 and in the event of the modular version, the upper section 222 is the section that mates with the stem 1 10. The head 220 further includes a lower section 224 that extends radially outward from the upper section 222. The lower section 224 has an outer diameter and shape that matches the outer diameter and shape of the device (implant) 20. An underface or under-surface 225 of the lower section 224 is constructed to have a size and shape that matches the outer surface shape of the device or graft.

[0074] The head 220 is preferably transparent in nature to allow for visualization of the native surface under the head 220 as well as around the head 220. For example, the head 220 can be formed of a clear polymer and therefore, when the user looks down at the tool 200. and the head 220 thereof, the transparent nature allows the user to directly observe the target site. In addition, the head 220, and in particular, the lower section 224, can include one or more windows 226. The windows 226 are formed in non-essential regions of the head 220. The presence of the windows 226 also allows visualization of the native surface under as well as around the tool 200.

[0075] Unlike the tool 100, the tool 200 is constructed to have both fixed and movable feet. More specifically, the head 220 includes one or more fixed feet 230 and there are one or more movable feet 235. In the illustrated embodiment, there are two fixed feet 230 and there are two movable feet 270

[0076] The one or more fixed feet 230 are formed along a bottom of the lower section 224 of the head 220. The feet 230 are located along the perimeter of the lower section 224 and are circumferentially spaced apart from one another. In the illustrated embodiment, there are two fixed feet 230 that are oriented 180 degrees apart from one another. Between the fixed feet 230, the head 220 includes one or more and preferably a plurality of notches or cutouts 240 formed along the outer perimeter edge.

[0077] The sizing alignment tool 200 includes an outer sheath 250 that is hollow and includes an inner lumen that passes therethrough and accommodates and receives the stem 110. The outer sheath 250 has a tubular upper section 252 and a lower section defined by a pair of legs 260 that extend to and define a pair of movable feet 270. The movable feet 270 pass through the plurality of notches 240 and the height of the movable feet 270 can be adjusted relative to the one or more fixed feet 230 or adjusted relative to the modular stem 110 of the sizing alignment tool 200 by a mechanism described herein.

[0078] Alignment relative to the surgical site can be achieved by adjusting the height of the movable feet relative to the fixed feet. In the preferred embodiment, the height of the movable feet relative to the fixed feet is adjusted by a mechanism. The disclosed mechanism comprises a coupling between the head 220 that carries the fixed feet and the outer sheath 250 that carries the movable feet 270. More specifically, the mechanism is a threaded feature that comprises a protrusion 280 that extends outwardly from the lower section of the outer sheath. The through hole in protrusion 280 passes completely therethrough. The head 220 includes a threaded part 290 that has inner threads of the same characteristic size as the through hole in the protrusion 280. The protrusion 280 and the threaded part 290 are formed so that they can be axially aligned relative to one another, thereby causing the through and threaded holes to be axially aligned. This allows a threaded fastener 400 to be used to threadingly mate and adjustably attach the outer sheath 250 to the head 220. The threaded fastener 400 typically passes through a spring 285, located between protrusion 280 and threaded part 290 that maintains contact between protrusion 280 and the head of the threaded fastener 400. The threaded fastener 400 includes a head that allows a driver to be used to screw in or screw out the threaded fastener 400. While the cunent embodiment utilizes translational motion to adjust the relative position of the fixed and movable feet other degrees of freedom (e.g. rotation) can be utilized to achieve stability of the instrument on the native surface.

[0079] The adjustable (movable) feet 270 move together as a unit and their height relative to the fixed feet 230 is changed until the tool 200 is stable, meaning that all four feet 230, 270 are simultaneously in contact with the native surface. The threaded adjustment feature can be configured so that the variation in height is tracked and can be assessed relative to the geometry of the target osteochondral implant. For example, by adjusting height of the movable feet 270 via the threaded mechanism, the change in height can be measured by tracking the threaded mechanism’s angle of rotation. Another example, the fixed portion of the tool 200 can contain laser marks at defined intervals to track the change in height of the movable feet 270. The height of the movable feet 270 can also be adjusted by means other than a threaded feature, they can be adjusted by sliding with or without the aid of a mechanism and secured to the fixed feet 230 via clamping or other fixation methods. It will therefore be appreciated that two opposing feet are fixed, while two opposing feet are adjustable in an up and down direction to allow the user to position and manipulate the adjustable feet 270 until all four feet (two fixed and two movable) are in contact with the native surface. This allows the sizing alignment tool 200 to be positioned in a stable manner on the native surface. One it is in this stable position, the stem 110 is thus oriented perpendicular to the native surface, and, as discussed herein, this allows the user to anchor a pin that is perpendicular to the native surface. As with the first embodiment, the transparent nature of the head 220 and the windows 226 provides additional viewing of the native surface and defect.

[0080] It will also be appreciated that the shape and / or size of the fixed feet and the movable feet can be the same or can be different.

[0081] Method of Use of Tool 200

[0082] Figs. 15- 16 illustrate an exemplary method of use of the disclosed sizing alignment tool 200.

[0083] More specifically, Figs. 15-16 illustrate a local defect in the form of a local defect in cartilage.

[0084] Figs. 15-16 illustrate the use of the sizing alignment tool 200 that is placed over the local defect (damaged surface). As mentioned, the sizing alignment tool 200 not only assists in determining the proper size of the implant that is to be installed but it also is used to establish perpendicularity on a non-planar surface by placing all feet on the non-planar surface comprises the local defect in cartilage. More specifically, the sizing alignment tool 200 is positioned over the local defect and in contact with the tissue such that first all of the fixed feet 230 are in contact with the non-planar surface as shown in Fig. 15.

[0085] As shown in Fig. 15, the sizing alignment tool 200 allows for visualization of the damage (focal defect) and also guides the user in the selection of the correct sized replacement device / graft.

[0086] In this embodiment, after first contacting the fixed feet 230 with the non-planar surface, then the movable feet 270 can be adjusted using the adjustment mechanism until the movable feet 270 also are in contact with the non-planar surface. In the illustrated embodiment, the fastener 400 is manipulated to cause height adjustment (up and down) of the movable feet 270. In the sequence from Fig. 15 to Fig. 16, the movable feet 270 are lowered until contact is made.

[0087] Once the sizing alignment tool 200 is placed in the desired position with all four feet 230, 270 in contact with the non-planar surface, the stem 110 is thus position normal (perpendicular) to the non-planar surface. With the stem 110 being perpendicular to the non- planar surface, a pin that is delivered through the inner lumen of the stem 1 10 and is anchored within the tissue is likewise perpendicular to the non-planar surface. After the pin or the like is anchored in place, the sizing alignment tool 200 can be removed. The anchored pin can be used to guide a scoring tool and / or a drill / reamer or other tool.

[0088] Figs. 9-12 illustrate that the sizing alignment tool 100 can be used to prepare an osteochondral allograft for implantation into the surgical site and similarly, Figs. 17-20 illustrate that the sizing alignment tool 200 can be used to prepare an osteochondral allograft for implantation into the surgical site. When using the three-foot sizing alignment tool 100, the user marks anatomic directions (anterior, posterior, medial, and lateral on the sizing alignment tool 100 so that it can be positioned on the allograft in a similar location and orientation to match peripheral geometry and orientation of the surface at the surgical site. If the four-footed sizing alignment tool 200 is used as in Figs. 17-20, the user marks anatomic directions (anterior, posterior, medial, and lateral) on the sizing alignment tool 200 and the movable feet 270 should be left at the same height as the surgical site so that the tool 200 can be positioned on the allograft to match peripheral geometry and orientation of the allograft surface to the surgical site. To harvest an allograft, a coring tool 300 can be positioned and aligned using the outer surface of the sizing / alignment tool 100, 200.

[0089] Impaction tool 500 (Figs. 21-22)

[0090] In yet another aspect, additional tools are described herein for use in preparing a site for implanting an implant. The site is typically prepared by drilling the site using a drill (reamer) to create an implant bed. An implant trial can be used to ensure that the bed is created to the correct depth. Figs. 21 and 22 illustrate an impaction tool 500 to place an implant (device) to the correct depth.

[0091] It will be appreciated that many different types of implants can be used with the instrumentation disclosed herein.

[0092] For example, the implant can be in the form of a multicomponent implant disclosed and claimed by Applicant in U.S. Pat. No. 9,545,310, which is hereby incorporated by reference in its entirety. This implant is for the treatment, repair or replacement of defects and injuries in biological tissue, especially musculoskeletal tissue. More particularly, the multi-component implant can comprise a solid hydrogel to resist load, a porous hydrogel layer to enable cellular infiltration and implant-tissue integration, and a porous rigid base to which the solid and porous hydrogels are both attached.

[0093] The shape and size of the implant is based at least in part on the location of implantation and the local defect. In one embodiment, the implant can have a cylindrical shape.

[0094] The instrumentation includes a drill (reamer) bit that is configured to create an implant bed in which an implant (device) is inserted. The formed implant bed has a size and shape that is complementary to the implant. The drill bit is configured to be used with a traditional powered surgical drill / reamer.

[0095] As previously mentioned, the implant trial is configured to ensure that the bed is created to the correct depth.

[0096] The impaction tool 500 in Figs. 21 and 22 is configured to place an implant (device) to the correct depth. The impaction tool 500 includes a handle 510 and a head 520 at the distal of the handle 510.

[0097] The handle 510 is an elongated structure with a free (proximal) end of the handle 510 including an enlarged flat portion 530 to allow' the impaction tool 500 to be driven. In particular, the enlarged flat portion 530 allows the user to tap the implant into place via contact with a driver, such as a mallet, with the enlarged flat portion 530.

[0098] The transition from the handle 510 to the head 520 can have an outward taper shape leading to a distal head section 522 that has a uniform diameter. The distal head section 522 can have a cylindrical shape (with uniform diameter). The head 520, and in particular, the distal head section 522, defines a peripheral edge. The height of the distal head section 522 (peripheral edge) allows the user to assess the location of the hydrated surface when inserting the device (implant) in its dehydrated state.

[0099] An indicator or guide 521 is provided to assist the user in assessing the degree of insertion of the device (implant) within the bed. For example, in the illustrated embodiment, the indicator 521 is an annular-shaped notch or channel that is immediately above the distal head section 522. Other types of indicators can be used. For example, the indicator 521 can be an annular-shaped raised ring or can be indicia, such as a colored line, formed on the head 520. This indicator or marking functions in the following manner. In Fig. 22, it will be seen that the indicator 521 is level to the outer surface of the tissue in which the implant bed is formed. This indicator position is the target position that indicates that the implant is properly laid in the bed. In the event that the indicator 521 is above the surface of the tissue, this means that the implant is too high and not sufficiently laid in the bed. Conversely, if the indicator 521 is below the surface of the tissue, the implant is too low in the bed. This indicator provides an easy guide to assist the user in assessing the quality of the implant insertion in the bed.

[0100] The edge of the impaction tool 500 interfaces with the edge of the implant (device), thereby preserving the hydrogel-based implant. The head 520 can include one or more markings to determine alignment of the implant relative to a cartilage edge that is determined by the sizing alignment tool described herein.

[0101] Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

[0102] Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

[0103] Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim w'ith the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

[0104] Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

[0105] For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for’ or “step for’’ are recited in a claim.

Claims

What is claimed is:

1. A sizing alignment tool for sizing a surgical device and for aligning one or more surgical tools relative to a surface during an orthopedic procedure, the sizing alignment tool comprising: a hollow stem; and a head having an underside and a plurality of feet located along a bottom edge of the head, the head extending radially outward from the hollow stem which is axially aligned with a center of the head.

2. The sizing alignment tool of claim 1, wherein the stem is detachably coupled to the head.

3. The sizing alignment tool of claim 1, wherein the stem is integral attached to the head and defines a single part.

4. The sizing alignment tool of claim 1 , wherein the head includes a hollow upper section that receives one end of the stem.

5. The sizing alignment tool of claim 1, wherein the stem and the head are attached using a taper lock that is provided at the distal end of the stem.

6. The sizing alignment tool of claim 1, wherein the head is formed of a transparent material.

7. The sizing alignment tool of claim 1 , wherein the head has a cylindrical shaped hollow upper section and an outwardly tapered lower section.

8. The sizing alignment tool of claim 1 , wherein the head includes one or more windows formed therein.

9. The sizing alignment tool of claim 8, wherein each window is offset from the plurality of feet.

10. The sizing alignment tool of claim 8, wherein each window is located between a pair of windows of the plurality of windows.

11. The sizing alignment tool of claim 8, wherein there are a plurality of windows.

12. The sizing alignment tool of claim 1, wherein the plurality of feet comprises three feet circumferentially spaced apart along the bottom edge at an outer periphery of the head.

13. The sizing alignment tool of claim 1. wherein bottom surfaces of the plurality of feet lie in a common plane.

14. The sizing alignment tool of claim 13, wherein the common plane is perpendicular to a center axis of the stem.

15. The sizing alignment tool of claim 1, wherein a diameter of the head corresponds to a size of the surgical device.

16. A sizing alignment tool for sizing a surgical device and for aligning one or more surgical tools relative to a surface during an orthopedic procedure, the sizing alignment tool comprising: a hollow stem; a head having an underside and a plurality of first feet located along a bottom edge of the head, the head extending radially outward from the hollow stem which is axially aligned with a center of the head; and a hollow outer sheath that receives the hollow stem and has one or more second feet, wherein the hollow outer sheath is coupled to the head such that the hollow outer sheath can moved relative to the head to allow a position of the one or more second feet relative to the plurality of first feet to be altered.

17. The sizing alignment tool of claim 16, wherein the stem is detachably coupled to the head.

18. The sizing alignment tool of claim 16, wherein the stem is integral attached to the head and defines a single part.

19. The sizing alignment tool of claim 16, wherein the head includes a hollow upper section that receives one end of the stem.

20. The sizing alignment tool of claim 16, wherein the stem and the head are attached using a taper lock that is provided at the distal end of the stem.

21. The sizing alignment tool of claim 16, wherein the head is formed of a transparent material.

22. The sizing alignment tool of claim 16, wherein the head has a cylindrical shaped hollow upper section and an outwardly tapered lower section.

23. The sizing alignment tool of claim 16, wherein the head includes one or more windows formed therein.

24. The sizing alignment tool of claim 23, wherein each window is offset from the plurality of feet.

25. The sizing alignment tool of claim 23, wherein each window is located between a pair of windows of the plurality of windows.

26. The sizing alignment tool of claim 23, wherein there are a plurality of windows.

27. The sizing alignment tool of claim 16, wherein the plurality of first feet comprises two feet spaced apart opposite one another along the bottom edge at an outer periphery of the head.

28. The sizing alignment tool of claim 16, wherein bottom surfaces of the plurality of first feet lie in a common fixed plane,29. The sizing alignment tool of claim 16, wherein the one or more second feet comprise a plurality of second feet, wherein the outer sheath has a hollow upper section that receives the stem and a plurality of legs with the plurality of second feet located at bottom ends of the plurality of legs.

30. The sizing alignment tool of claim 16, wherein a fastener couples the outer sheath to the head.

31. The sizing alignment tool of claim 30, wherein the fastener comprises a threaded fastener.

32. The sizing alignment tool of claim 31, wherein the hollow outer sheath includes a hollow' protrusion that extends outwardly from the lower section of the outer sheath and includes a through hole in the hollow' protrusion and the head includes a threaded part that has a threaded bore, the threaded fastener passing through a spring, located betw een the hollow protrusion and the threaded part, and is threadingly engaged w'ith the threaded bore, thereby adjustably coupling the hollow outer sheath to the head, the spring being configured to maintain contact between the hollow protrusion and a head of the threaded fastener.

33. The sizing alignment tool of claim 16, w'herein each second foot passes through a notch formed along a peripheral edge of the head.

34. The sizing alignment tool of claim 33, wherein the one or more second feet comprise two second feet disposed opposite one another and the head includes two notches, each second foot being located between two first feet.

35. An impaction tool comprising a handle and a head that is configured to drive an implant into an implant bed.

36. The impaction tool of claim 35, wherein the head includes an indicator to determine alignment of the implant relative to a cartilage edge.

37. The impaction tool of claim 36, w'herein the indicator comprises an annul ar- shaped notch or channel that is immediately above a distal head section of the head, the distalhead section having a uniform diameter and a section above the distal head section being an outwardly tapered section.

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