JOINT IMPLANT APPARATUS, SYSTEM, AND METHOD

An improved joint implant apparatus, system, and method. The system includes an implant having a bone-facing articular surface configured to replace at least part of a natural articular surface of a bone adjacent to a joint. The system also includes a transosseous coupler and a bone anchor configured to reside proximate another surface of the bone, separated from the natural articular surface by a bone tunnel. The bone anchor is configured to couple the transosseous coupler to the bone such that the transosseous coupler retains the implant in place on the natural articular surface of the bone.

TECHNICAL FIELD

The present disclosure relates to surgical systems, methods, instruments, and/or devices. More specifically, the present disclosure relates to improved surgical systems, methods, devices, and/or instruments for mitigating effects of arthritis and/or osteochondral defects (OCD), such as osteochondral lesions (OCL) within a joint of a patient's body.

BACKGROUND

Many patients suffer with joint pain and/or reduced joint kinematics. Various conditions may affect skeletal joints such as the injury, disease, deterioration, elongation, shortening, or rupture of soft tissues, cartilage, and/or bone associated with the joint and consequent laxity, pain, loss of movement, and/or deformity. Such conditions can adversely impact the daily activities of the patient.

The medical industry uses a variety of procedures to address these conditions, including: various osteotomy procedures, joint fusion procedures, fracture fixation procedures, joint resurfacing procedures, implants, joint spacers, and the like. Such procedures can be performed throughout the body and on various joints of the body.

However, these procedures, devices, and/or system have limitations. For example, certain procedures may remove a high percentage of bone of an articular surface of the joint. Other procedures may fuse the joint which may address pain but can limit mobility and activity of the patient. Other procedures and/or prosthesis may be prone to periprosthetic fractures and/or prosthetic dislocation.

Accordingly, a need exists for an improved joint implant apparatus, system, and method that removes minimal bone material, mechanically secures the implant, secures the implant with an adjustable level of tension, enables natural movement of the joint, and provides adjunctive fixation.

SUMMARY

The various apparatus, devices, systems, and/or methods of the present disclosure have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently arthroplasty and/or implants. One general aspect of the present disclosure can include an implant having a joint-facing articular surface configured to replace at least part of a natural articular surface of a bone adjacent to a joint, and a transosseous coupler. The system may include a bone anchor configured to reside proximate another surface of the bone. The bone anchor can be separated from the natural articular surface by a bone tunnel. The system may include a transosseous coupler configured to couple the implant to the bone anchor and the bone anchor may be configured to couple the transosseous coupler to the bone such that the transosseous coupler retains the implant in place on the natural articular surface of the bone.

Implementations may include one or more of the following features. The system in which the transosseous coupler applies tension on the implant, where the tension holds the joint-facing articular surface in place on a distal end of the bone. A first diameter of the joint-facing articular surface is smaller than a second diameter of the natural articular surface of the bone. A first diameter of the joint-facing articular surface is greater than a width of an osteochondral lesion (OCL) of the natural articular surface and smaller than a second diameter of the natural articular surface of the bone. The system may include an implant that may include a body having a joint-facing articular surface, a convex posterior surface, and an edge between the joint-facing articular surface and the convex posterior surface. The bone tunnel may include a distal end and a proximal end and the proximal end exits between a distal end of the bone and a proximal end of the bone; and the distal end of the bone tunnel exits within a bone pocket that extends proximally from the natural articular surface into the bone. The implant may be coupled to the bone anchor by a transosseous coupler. A body of the implant may seat within the bone pocket with the edge extending above the natural articular surface of the bone. The joint-facing articular surface may be convex and a top of the joint-facing articular surface may be congruent with cartilage around the implant. The joint-facing articular surface may be convex with the edge being circular. The convex posterior surface may have an implant radius greater than a bone radius of the bone pocket. The transosseous coupler may include a tether configured to engage with a first connector coupled to the implant and configured to engage with a second connector coupled to the bone anchor.

In one aspect, for certain implementations the implant may include a body that includes a joint-facing articular surface, a posterior surface configured to seat within a bone pocket, and a shoulder between the joint-facing articular surface and the posterior surface. The shoulder may engage a natural articular surface of the bone when the implant is coupled by a transosseous coupler to the bone.

One general aspect of the present disclosure can include an arthroplasty implant configured to engage a distal articular surface of a metatarsal bone; a bone anchor secured to the metatarsal bone away from the distal articular surface, and a tether configured to couple the arthroplasty implant and the bone anchor.

Implementations may include one or more of the following features. The arthroplasty implant system may include an arthroplasty implant that may include: an articular implant where the articular implant is embedded within a bone pocket of the distal articular surface when the tether couples the articular implant to the bone anchor such that bone pocket retains the articular implant in place during osseointegration of the articular implant to the metatarsal bone. The arthroplasty implant may include a spacer configured to maintain separation between the distal articular surface and an articular surface of an adjacent phalanx bone. The arthroplasty implant may include: a body having a joint-facing articular surface and a convex posterior surface configured to engage the distal articular surface by way of a bone pocket formed within the distal articular surface; an edge between the joint-facing articular surface and the convex posterior surface; and a connector configured to engage with the tether and secure the arthroplasty implant to the tether.

The tether couples the arthroplasty implant to the bone anchor through a bone tunnel that extends from the bone pocket such that when the tether couples the arthroplasty implant to the bone anchor at least a portion of the edge contacts a surface of the bone pocket below the distal articular surface. The bone tunnel may include a proximal opening near a dorsal surface of the metatarsal bone. The bone anchor sits within the bone tunnel and within the proximal opening and the bone anchor may include: a cylindrical body may include an opening that extends from one end of the cylindrical body to the other end and external threads on an outside surface of the cylindrical body, the external threads configured to engage an internal surface of the bone tunnel, and a tether locking feature configured to sit within the opening of the cylindrical body and couple a proximal end of the tether to the bone anchor. The arthroplasty implant may seat within the bone pocket such that a top of the joint-facing articular surface is congruent with or below a surface of surrounding cartilage of the distal articular surface and the edge is below the surface of surrounding cartilage when the tether couples the arthroplasty implant to the bone anchor.

One general aspect of the present disclosure can include an articular implant system for a metatarsophalangeal joint, the system having an implant configured to seat within a bone pocket of an articular surface of a metatarsal, the implant may include: a convex distal surface; a semispherical proximal surface that extends from the convex distal surface, the semispherical proximal surface having an implant radius that matches a bone radius of the bone pocket; and where the semispherical proximal surface engages a surface of the bone pocket to retain the implant within the bone pocket.

Implementations may include one or more of the following features. The articular implant system may include: a tether that may include a distal end and a proximal end, the distal end configured to connect the tether to the implant; an anchor configured to secure the proximal end of the tether to the metatarsal away from the bone pocket; and where the anchor and tether adjunctively secure the implant to the metatarsal. The implant may include: a distal body that may include the convex distal surface; a proximal body that may include the semispherical proximal surface; and a fastener configured to couple the distal body to the proximal body.

One general aspect of the present disclosure can include a method for deploying an articular implant in a metatarsophalangeal (MTP) joint of a patient. The method includes forming a bone pocket in an articular surface of a metatarsal bone, the bone pocket sized and positioned to resect at least one osteochondral lesion; forming a bone tunnel may include a distal tunnel end and a proximal tunnel end, the bone tunnel configured such that the distal tunnel end connects the bone pocket and the proximal tunnel end connects to an external surface of the metatarsal bone; passing a tether between the distal tunnel end and the proximal tunnel end of the bone tunnel, the tether having a distal tether end and a proximal tether end; securing the distal tether end to an articular implant; and securing the proximal tether end within the bone tunnel.

Implementations may include one or more of the following features. The method may also include: reaming the articular implant out of the bone pocket to a size that supports a second articular implant having a greater diameter than the articular implant; restoring the bone tunnel; passing a second tether through the restored bone tunnel; securing a distal tether end of the second tether to the second articular implant; and securing a proximal tether end of the second tether within the restored bone tunnel as at least part of a revision procedure.

It is to be understood that the drawings are for purposes of illustrating the concepts of the disclosure and may or may not be drawn to scale. Furthermore, the drawings illustrate exemplary embodiments and do not represent limitations to the scope of the present disclosure.

DETAILED DESCRIPTION

Exemplary embodiments of the present disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus and method, as represented in the Figures, is not intended to limit the scope of the present disclosure, as claimed in this or any other application claiming priority to this application but is merely representative of exemplary embodiments of the present disclosure.

Standard medical planes of reference and descriptive terminology are employed in this disclosure. While these terms are commonly used to refer to the human body, certain terms are applicable to physical objects in general. A standard system of three mutually perpendicular reference planes is employed. A sagittal plane divides a body into right and left portions. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. A mid-sagittal, mid-coronal, or mid-transverse plane divides a body into equal portions, which may be bilaterally symmetric. The intersection of the sagittal and coronal planes defines a superior-inferior or cephalad-caudal axis. The intersection of the sagittal and transverse planes defines an anterior-posterior axis. The intersection of the coronal and transverse planes defines a medial-lateral axis. The superior-inferior or cephalad-caudal axis, the anterior-posterior axis, and the medial-lateral axis are mutually perpendicular. Anterior means toward the front of a body.

Posterior means toward the back of a body. Superior or cephalad means toward the head. Inferior or caudal means toward the feet or tail. Medial means toward the midline of a body, particularly toward a plane of bilateral symmetry of the body. Lateral means away from the midline of a body or away from a plane of bilateral symmetry of the body. Axial means toward a central axis of a body. Abaxial means away from a central axis of a body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. Proximal means toward the trunk of the body. Proximal may also mean toward a user, viewer, or operator. Distal means away from the trunk. Distal may also mean away from a user, viewer, or operator. Dorsal means toward the top of the foot. Plantar means toward the sole of the foot. Antegrade means forward moving from a proximal location/position to a distal location/position or moving in a forward direction. Retrograde means backward moving from a distal location/position to a proximal location/position or moving in a backwards direction. Sagittal refers to a midline of a patient's anatomy, which divides the body into left or right halves. The sagittal plane may be in the center of the body, splitting it into two halves. Prone means a body of a person lying face down. Supine means a body of a person lying face up.

As used herein, “preoperative” or “PRE-OP” refers to any activity, method, feature, or aspect performed before a surgical procedure. As used herein, “intraoperative” or “INTRA-OP” refers to any activity, method, feature, or aspect performed during a surgical procedure. As used herein, a “fixation” or “fixation device” refers to an apparatus, instrument, structure, device, component, member, system, assembly, step, process, or module structured, organized, configured, designed, arranged, or engineered to connect two structures either permanently or temporarily. The two structures may be one or the other or both of man-made and/or biological tissues, hard tissues such as bones, teeth or the like, soft tissues such as ligament, cartilage, tendon, or the like. In certain embodiments, fixation is used as an adjective to describe a device or component or step in securing two structures such that the structures remain connected to each other in a desired position and/or orientation. Fixation devices can also serve to maintain a desired level of tension, compression, or redistribute load and stresses experienced by the two structures and can serve to reduce relative motion of one part relative to others. Examples of fixation devices are many and include both those for external fixation as well as those for internal fixation and include, but are not limited to pins, wires, Kirschner wires (K-wires), screws, anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, interbody cages, fusion cages, and the like.

As used herein, a “deploy” or “deployment” refers to an act, action, process, system, method, means, or apparatus for inserting an implant or prosthesis into a part, body part, and/or patient. “Deploy” or “deployment” can also refer to an act, action, process, system, method, means, or apparatus for placing something into therapeutic use. A device, system, component, medication, drug, compound, or nutrient may be deployed by a human operator, a mechanical device, an automated system, a computer system or program, a robotic system, or the like.

“Cortical bone” refers to a type of bone tissue. Cortical bone is a type of bone tissue typically found between an external surface of a bone and an interior area of the bone. Cortical bone is more dense and typically stronger structurally than other types of bone tissue.

As used herein, “implant” refers to a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Often medical implants are man-made devices, but implants can also be natural occurring structures. The surface of implants that contact the body may be made of, or include a biomedical material such as titanium, cobalt chrome, stainless steel, carbon fiber, another metallic alloy, silicone, polymer, Synthetic polyvinyl alcohol (PVA) hydrogels, biomaterials, biocompatible polymers such as PolyEther Ether Ketone (PEEK) or a polylactide polymer (e.g. PLLA) and/or others, or apatite, or any combination of these depending on what is functional and/or economical. Implants can have a variety of configurations and can be wholly, partially, and/or include a number of components that are flexible, semiflexible, pliable, elastic, supple, semi-rigid, or rigid.

In some cases implants contain electronics, e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents. Orthopedic implants may be used to alleviate issues with bones and/or joints of a patient's body.

As used herein, “attribute” refers to any property, trait, aspect, quality, data value, setting, or feature of an object or thing.

Various conditions may adversely affect skeletal joints such as the injury, disease, deterioration, elongation, shortening, or rupture of soft tissues, cartilage, and/or bone associated with the joint and consequent laxity, pain, loss of movement, and/or deformity. As mentioned, a variety of procedures can be used to address these conditions, including: various osteotomy procedures, joint fusion procedures, fracture fixation procedures, joint resurfacing procedures, implants, joint spacers, and the like. Such procedures can be performed throughout the body and on various joints of the body.

However, these procedures, devices, and/or system have limitations. For example, certain procedures may remove a high percentage of bone of an articular surface of the joint. Other procedures may fuse the joint which may address pain but can limit mobility and activity of the patient. Other procedures and/or prosthesis may be prone to periprosthetic fractures and/or prosthetic dislocation.

The present disclosure discloses an improved joint implant apparatus, system, and method that removes minimal bone material, mechanically secures the implant, secures the implant with an adjustable level of tension, enables or maintains more natural movement of the joint, and provides adjunctive fixation.

FIG.1is a perspective view of foot joint illustrating an implant system100according to one embodiment. The implant system100can be used on a variety of joints within the body of a patient. “Joint” or “Articulation” refers to the connection made between bones in a human or animal body which link the skeletal system to form a functional whole. Joints may be biomechanically classified as a simple joint, a compound joint, or a complex joint. Joints may be classified anatomically into groups such as joints of hand, elbow joints, wrist joints, axillary joints, sternoclavicular joints, vertebral articulations, temporomandibular joints, sacroiliac joints, hip joints, knee joints, articulations of foot, and the like. (Search “joint” on Wikipedia.com Dec. 19, 2021. CC-BY-SA 3.0 Modified. Accessed Jan. 20, 2022.)

FIG.1illustrates one exemplary embodiment of an implant system100that can be used with one or more joints of the foot. The foot includes a number of joints and a number of bones, not all of the bones and joints are described herein to provide clarity for the present disclosure.FIG.1illustrates a few of the bones and joints where an implant system100can be deployed.FIG.1illustrates a number of bones of a foot including a first metatarsal110, other metatarsal bones120, a first proximal phalanx130, other proximal phalanges140, intermediate phalanges150, a first distal phalanx160, and other distal phalanges170.

The first metatarsal110includes a proximal end180(also referred to as a base), a distal end190(also referred to as a head), and a body200that connects the proximal end180and the distal end190. The body200includes a dorsal surface210, a plantar surface220, a medial surface230, and a lateral surface240.

For sake of clarity, while embodiments can be used on other joints of a patient, this disclosure will describe embodiments with respect to the metatarsophalangeal (MTP) joint. Those of skill in the art will appreciate that embodiments within the scope of the present disclosure will not and are not limited to those use and implementation in the MTP joint alone and that embodiments of the disclosed solution can be used in one or more other joints of a patient. The metatarsophalangeal (MTP) joint is a joint between a metatarsal and a proximal phalangeal bone (phalanx) of a toe of the foot. More specifically, this disclosure will focus on exemplary embodiments that can be used on the MTP joint250between the first metatarsal110and the first proximal phalanx130.

The MTP joint250includes an articular surface of the first metatarsal110, an articular surface of the first proximal phalanx130, and one or more layers of cartilage (not shown). In certain embodiments, the articular surface of the first metatarsal110is a natural articular surface260and the articular surface of the first proximal phalanx130is also a natural articular surface270. Of course either surface (260,270) or both surfaces (260,270) can be artificial articular surfaces. “Articular surface” refers to a surface of a structure that is coupled to, and may cooperate with, other structures of a joint of a human or animal to enable movement of structures of the joint. A natural articular surface is an articular surface created as part of natural, or human facilitated, cellular growth and development of bones of a patient.

FIG.2is a perspective view of a system300for use on a foot joint according to one embodiment. The system300includes an implant310, a transosseous coupler320, and a bone anchor330.

The implant310serves to provide a structure that can be used to replace at least a portion of a natural articular surface of a bone (i.e., natural articular surface260). The implant310can have a variety of shapes, come in different sizes, be made of different materials or combinations of materials (i.e., composites or alloys), and/or a variety of different designs.

In one embodiment, the implant310includes a joint-facing articular surface312. A joint-facing articular surface312is a surface that faces a joint, such as MTP joint250. The joint-facing articular surface312can replace at least part of a natural articular surface of a bone adjacent to a joint. For example, inFIG.1, the joint-facing articular surface312may replace at least part of the natural articular surface260of the first metatarsal110in an MTP joint250. Of course, the implant310may be deployed on any articular surface of a joint of the patient. In certain embodiments, the joint-facing articular surface312is a smooth surface that minimizes friction between the joint-facing articular surface312and other articular surfaces of a joint. The size of the joint-facing articular surface312may vary according to the needs of the patient. In certain embodiments, the joint-facing articular surface312is sized to be just larger in diameter than a lesion or other area of the natural articular surface260being replaced. In other embodiments, the joint-facing articular surface312is as large in diameter or greater in diameter than the natural articular surface260.

In certain embodiments, the implant310and/or the joint-facing articular surface312may be a structure different from a rigid structure. For example, in one embodiment, the joint-facing articular surface312may be a suture ball. A suture ball is generally a length of suture material gathered into collection of loops, lengths, bends, and/or twists of one or more lengths of suture such that the collection covers a particular area and may resemble a ball shape. In certain embodiments, a suture ball may be a knotless suture in which one or more ends of the knotless suture may be pulled and thereby cause the knotless suture to bunch up or cinch up into a collection of loops, lengths and bends and twists. An implant310embodied as a suture ball may have less coefficient of friction than an implant310with a rigid joint-facing articular surface312. Further, implant310embodied as a suture ball may be softer than an implant310with a rigid joint-facing articular surface312.

The terms “suture” and/or “suture strand” are used herein to mean any strand or flexible member, natural or synthetic, able to joint tissue of a patient and/or to be anchored in a bone tunnel or to hard tissue and useful in a surgical procedure. In certain embodiments, “suture” and/or “suture strand” refers to a flexible line or flexible member of natural material, natural biological material, biomaterial, biomimetic materials, manmade material, or a combination of these either in a single structure, a composite structure, or a plurality of tissue structures that extend in parallel and/or may be woven or bonded together. In certain embodiments, a suture may be long and thin. In certain embodiments, a suture may be planar or may be elastic or inelastic. Examples of a suture include, but are not limited to, a thread, a suture, suture tape, a woven structure, a fibrous material, a cord, and/or any of these in combination with each other, and the like.

The transosseous coupler320serves to couple an implant310to a bone. The transosseous coupler320may create a direct coupling or an indirect coupling by way of one or more other components or structures. The direct coupling or an indirect coupling may be between the transosseous coupler320and the implant310, between the transosseous coupler320and the bone, and/or between the implant310and a structure coupled to bone. The transosseous coupler320can have a variety of shapes, come in different sizes, be made of different materials or combinations of materials (i.e., composites or alloys), and/or a variety of different designs.

As used herein, “coupling”, “coupling member”, or “coupler” refers to a mechanical device, apparatus, member, component, or structure, that is organized, configured, designed, arranged, or engineered to connect, or facilitate the connection of, the two or more parts, objects, or structures. In certain embodiments, a coupling can connect adjacent parts or objects at their ends. In certain embodiments, a coupling can be used to connect two shafts together at their ends for the purpose of transmitting power. In other embodiments, a coupling can be used to join two pieces of rotating equipment while permitting some degree of misalignment or end movement or both. In certain embodiments, couplings may not allow disconnection of the two parts, such as shafts during operation. (Search “coupling” on Wikipedia.com Jul. 26, 2021. CC-BY-SA 3.0 Modified. Accessed Jul. 27, 2021.) A coupler may be flexible, semiflexible, pliable, elastic, or rigid. A coupler may join two structures either directly by connecting directly to one structure and/or directly to the other or indirectly by connecting indirectly (by way of one or more intermediary structures) to one structure, to the other structure, or to both structures. “Transosseous” refers to a structure, activity, action, or motion that crosses through bone or passes through bone.

In certain embodiments, the transosseous coupler320is part of, or formed together with, the implant310such that the transosseous coupler320and implant310are a single unitary component. In other embodiments, the transosseous coupler320is part of, or formed together with, a bone anchor330such that the transosseous coupler320and bone anchor330are a single unitary component. In still other embodiments, the transosseous coupler320may be a separate and distinct structure that may be coupled to either or both of an implant310and/or a bone anchor330.

FIG.2illustrates an embodiment in which the transosseous coupler320is part of the implant310. The transosseous coupler320may be made of the same material or different material from the implant310. In the illustrated embodiment, the transosseous coupler320is flexible and is an elongated structure. The transosseous coupler320is long enough to couple the implant310to a bone fixation point and/or to a bone anchor330. The transosseous coupler320is configured and designed to apply a tension force between the implant310and a bone fixation point and/or to a bone anchor330. As used herein, a “tension” refers to a force that is applied to both ends of a structure. The structure may have a variety of shapes including fat, thin, wide, elongated, or the like. In one example, a ligament such as a lateral collateral ligament may experience tension due to how the ligament is attached to a femur bone and tibia bone and stretched during flexing of the knee joint. In another example, a tether, suture, or other structure may experience and/or transfer tension as the structure is connected between an implant and an anchor, such as a bone anchor.

In certain embodiments, the transosseous coupler320is a flexible member such as a suture, knotless suture, suture ball, suture connected to a suture ball, or the like. In such an embodiment, the flexible transosseous coupler320may be coupled to, couplable to, or otherwise joined to one, or the other, or both of the implant310and the bone anchor330or a bone fixation point.

The bone anchor330serves to couple the transosseous coupler320to bone. As used herein, an “anchor” refers to an apparatus, instrument, structure, member, part, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to secure, retain, stop, and/or hold, an object to or at a fixed point, position, or location. Often, an anchor is coupled and/or connected to a flexible member such as a tether, chain, rope, wire, thread, suture, suture tape, or other like object. Alternatively, or in addition, an anchor may also be coupled, connected, and/or joined to a rigid object or structure. In certain embodiments, an anchor can be a fixation device. Said another way, a fixation device can function as an anchor. A bone anchor is an anchor, a type of fixation device, that can engage bone and can couple or connect another structure to bone. In certain embodiments, the bone anchor is a corkscrew anchor.

Those of skill in the art will appreciate that a variety of different bone anchor330may be used with the present disclosure. Each of these is considered within the scope of the claims which define the presented solution. A few example bone anchors are illustrated and described herein.

In the illustrated embodiment, the bone anchor330is a cylindrical screw fastener configured to engage with walls of a bone tunnel and secure the transosseous coupler320to a wall of the bone tunnel. In one example embodiment, the bone anchor330may include external threads332configured to engage with walls of a bone tunnel. In one embodiment, the bone anchor330may engage an end of the transosseous coupler320and press the end against a wall of the bone tunnel. In this manner, the bone anchor330may secure the end of the transosseous coupler320to bone such that the transosseous coupler320retains the implant310in place on the natural articular surface (i.e., natural articular surface260) of the bone. The bone anchor330and transosseous coupler320may be coupled to each other using an interference fit between the bone anchor330and the bone. The transosseous coupler320may couple the implant310to the bone anchor330.

FIG.3is a perspective side view of the system ofFIG.2deployed on a foot joint according to one embodiment.FIG.3illustrates an MTP joint250between a first proximal phalanx130and a first metatarsal110. In one embodiment, the first metatarsal110may include a bone tunnel340. The bone tunnel340may include a proximal end342and a distal end344.

The bone tunnel340may be one type of opening. As used herein, an “opening” refers to a gap, a hole, an aperture, a port, a portal, a space or recess in a structure, a void in a structure, or the like. In certain embodiments, an opening can refer to a structure configured specifically for receiving something and/or for allowing access. In certain embodiments, an opening can pass through a structure. In other embodiments, an opening can exist within a structure but not pass through the structure. An opening can be two-dimensional or three-dimensional and can have a variety of geometric shapes and/or cross-sectional shapes, including, but not limited to a rectangle, a square, or other polygon, as well as a circle, an ellipse, an ovoid, or other circular or semi-circular shape. As used herein, the term “opening” can include one or more modifiers that define specific types of “openings” based on the purpose, function, operation, position, or location of the “opening.” As one example, a “fastener opening” refers to an “opening” adapted, configured, designed, or engineered to accept or accommodate a “fastener.”

In one embodiment, the bone tunnel340extends from the natural articular surface260of a bone, such as a first metatarsal110, to another surface of the bone. The another surface can be one of the dorsal surface210, the plantar surface220, the medial surface230, and/or the lateral surface240(not shown inFIG.3). The proximal end342may exit at, or near, the another surface. In the illustrated embodiment, the proximal end342exits at, or near, the dorsal surface210. The distal end344may exit directly on the natural articular surface260. In another embodiment, the distal end344may exit indirectly onto the natural articular surface260by way of another structure, such as a recess or opening, such as a bone pocket (described in more detail below). The length and diameter of the bone tunnel340can vary based on a variety of factors including the age, gender, health, size, the joint involved, and/or bone condition of a patient. In one embodiment, the diameter may be between about 1.5 mm and 1.6 mm and the length may be between about 10 mm to about 15 mm.

Furthermore, the another surface for the proximal end342to exit can vary based on similar factors, including surgeon preference. Having the proximal end342exit at, or near the dorsal surface210may be advantageous because this location may facilitate access by a surgeon for the procedure. In addition, the bone tunnel340may be positioned proximal to or through a physes or epiphyseal plate such that bone growth that closes the bone tunnel340after the procedure and during healing may be rapid and complete. In this manner, the system300serves as provisional, adjunctive, or temporary fixation until the bone heals and osseointegrates the implant310into the bone.

FIG.3illustrates one embodiment in which the bone anchor330resides proximate to the another surface (e.g., dorsal surface210) and is separated from the natural articular surface260by the bone tunnel340. The bone anchor330may be of a number of different varieties. In one embodiment, the bone anchor330is an interference screw that seats within the proximal end342. The interference screw may secure a free end of the transosseous coupler320to an inside wall of the bone tunnel340. The bone anchor330couples the transosseous coupler320to the bone (e.g., first metatarsal110) such that the transosseous coupler320retains the implant310in place on the natural articular surface260. Once deployed the transosseous coupler320applies tension on the implant310. The tension is applied in the direction of the bone anchor330. The tension holds the joint-facing articular surface312in place on the distal end190of the bone (e.g., first metatarsal110). In certain embodiments, the tension provides provisional, adjunctive, or temporary fixation until the bone heals and osseointegrates the implant310into the bone.

FIG.4is an anterior view of a natural articular surface of a bone. The bone may be a first metatarsal110and the natural articular surface maybe the natural articular surface260of the head of the first metatarsal110. In this example, the natural articular surface260includes an osteochondral lesion (OCL)350. As used herein, an “osteochondral lesion” (OCL) is a lesion within the cartilage covering at least a portion of a bone at a joint. As used herein, a “lesion” refers to any damage or abnormal change in the tissue of an organism, usually caused by disease or trauma. (Search “lesion” on Wikipedia.com 20 Oct. 2021. CC-BY-SA 3.0 Accessed Dec. 1, 2021.)

Advantageously, the OCL350may have a diameter D1that is smaller than a diameter D2of the natural articular surface260. In certain embodiments, the system300can be used to treat the OCL350such that a minimal amount of bone and/or soft tissue of the natural articular surface260is removed for the procedure.

For example, a surgeon may select a size of implant310with a diameter D3(the diameter of the joint-facing articular surface312) that is smaller than the diameter D2of the natural articular surface260of the bone and greater than a diameter D1, or width, of the OCL350. The diameter D3of the implant310may maintain a 1-2 mm gap between the joint-facing articular surface312and an edge of the natural articular surface260. The system300, when deployed, results in minimal bone removal. Retaining bone on the natural articular surface260can promote mobility and use of the joint and provide options for future treatments of the joint, such as in a revision, for example, if a condition reemerges or gets worse over time.

FIGS.5A-5Dis a perspective view, bottom view, perspective side view, and top view, respectively of an implant500according to one embodiment. The embodiment of these figures is but one example of a variety of different implants and/or implant configurations that can be used with the present disclosure.

In the illustrated embodiment, the implant500is a solid structure that includes a body510and an edge520. As used herein, a “body” refers to a main or central part of a structure. The body may serve as a structural component to connect, interconnect, surround, enclose, and/or protect one or more other structural components. A body may be made from a variety of materials including, but not limited to, metal, plastic, ceramic, wood, fiberglass, acrylic, carbon, biocompatible materials, biodegradable materials or the like. A body may be formed of any biocompatible materials, including but not limited to biocompatible metals such as Titanium, Titanium alloys, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, shape memory alloys such as Nitinol, biocompatible ceramics, and biocompatible polymers such as Polyether ether ketone (PEEK) or a polylactide polymer (e.g. PLLA) and/or others. In one embodiment, a body may include a housing or frame or framework for a larger system, component, structure, or device. A body may include a modifier that identifies a particular function, location, orientation, operation, and/or a particular structure relating to the body. Examples of such modifiers applied to a body, include, but are not limited to, “inferior body,” “superior body,” “lateral body,” “medial body,” and the like.

The body510may resemble a button or plug. In one embodiment, the body510has a circular cross section. The body510may include a joint-facing articular surface512and a posterior surface514. The joint-facing articular surface512is a part of the implant500that generally faces the joint. The joint-facing articular surface512may be convex and meet the posterior surface514at the edge520. The convex shape of the joint-facing articular surface512may be configured to simulate or emulate the shape and contour of a natural articular surface260of a joint. Furthermore, the convex shape may distribute loading during use of the joint from an apex516of the joint-facing articular surface512down and out towards the edge520.

The joint-facing articular surface512can have a variety of shapes and configurations. In one embodiment, the joint-facing articular surface512may be generally flat. In another embodiment, the joint-facing articular surface512may have a contour configured to facilitate articulation with a natural articular surface270of an adjacent bone.

In one embodiment, the posterior surface514is shaped to engage with a distal articular surface (e.g., natural articular surface260) of a bone. The posterior surface514may be shaped to engage with the distal articular surface by way of a bone pocket formed within the distal articular surface. In one example, the bone pocket may be concave shaped and the posterior surface514may be convex shaped to match or substantially match the concave shape of the bone pocket. A concave bone pocket and convex posterior surface514can enable the body510to seat within the bone pocket when deployed.

The edge520is a structure between the joint-facing articular surface512and the posterior surface514. As used herein, “edge” refers to a structure, boundary, or line where an object, surface, or area begins or ends. An edge can also refer to a boundary or perimeter between two structures, objects, or surfaces. An edge can also refer to a narrow part adjacent to a border. (search “edge” on Merriam-Webster.com. Merriam-Webster, 2021. Web. 3 Aug. 2021. Modified.) In certain embodiments, an edge can be a one dimensional or a two dimensional structure that joins two adjacent structures or surfaces. Furthermore, an edge may be at a perimeter of an object or within a perimeter or boundary of an object. In the illustrated embodiment, the edge520may have a circular cross-section.

In certain embodiments, the implant500may include a connector530. “Connector” refers to any structure configured, engineered, designed, adapted, and/or arranged to connect one structure, component, element, or apparatus to another structure, component, element, or apparatus. A connector can be rigid, pliable, elastic, flexible, and/or semiflexible. Examples of a connector include but are not limited any fastener. As used herein, a “fastener” or “fastener system” refers to any structure configured, designed, or engineered to join two structures. Fasteners may be made of a variety of materials including metal, plastic, composite materials, metal alloys, plastic composites, and the like.

Examples of fasteners include, but are not limited to screws, rivets, bolts, nails, snaps, hook and loop, set screws, bone screws, nuts, posts, pins, thumb screws, and the like. Other examples of fasteners include, but are not limited to wires, Kirschner wires (K-wire), anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, sutures, soft sutures, soft anchors, tethers, interbody cages, fusion cages, and the like. In certain embodiments, the term fastener may refer to a fastener system that includes two or more structures configured to combine to serve as a fastener.

An example of a fastener system is a rod or shaft having external threads and an opening or bore within another structure having corresponding internal threads configured to engage the external threads of the rod or shaft. In certain embodiments, the term fastener may be used with an adjective that identifies an object or structure that the fastener may be particularly configured, designed, or engineered to engage, connect to, join, contact, or couple together with one or more other structures of the same or different types. For example, a “bone fastener” may refer to an apparatus for joining or connecting one or more bones, one or more bone portions, soft tissue and a bone or bone portion, hard tissue and a bone or bone portion, an apparatus and a bone or portion of bone, or the like.

In the illustrated embodiment, the connector530includes cut outs532a,band an opening534. The cut outs532a,bmay facilitate aligning a coupler (e.g., a transosseous coupler320) with a center of the implant500. Those of skill in the art will recognize that the cut outs532a,bmay be optional and may or may not be included in an embodiment. The opening534may engage with the coupler to couple the implant500and the coupler. In the illustrated embodiment, the opening534extends from one cut out532ato an opposite cut out532. In one embodiment, the coupler may be a tether and the connector530engages with the tether and secures the implant500to the tether. For example, one end of a tether may be passed through opening534and the tether may be tied into a knot to secure the tether to the implant500.

FIG.5Eis a perspective exploded view of an implant540according to another embodiment of the present disclosure.FIG.5Eincludes similar components, parts, devices, apparatus, features, and aspects as those disclosed and described in relation toFIGS.5A-5D, however the difference inFIG.5Eis that the body includes a distal body550and a proximal body560. The distal body550may include a convex distal surface similar, in certain embodiments, to the joint-facing articular surface512of implant500. The proximal body560may include a semispherical proximal surface similar, in certain embodiments, to the posterior surface514of implant500. Of course, the surfaces of the distal body550and proximal body560may be very different from those of other example embodiments included herein.

The implant540may also include a fastener570configured to couple the distal body550to the proximal body560. A variety of different fasteners can be used. In the illustrated embodiment, the fastener570includes a shaft572having external threads574and an opening576having internal threads578that correspond to the external threads574.

The implant540may be used in a variety of ways and can offer a variety of advantages for a particular use. For example, in one embodiment, the proximal body560and the distal body550may be made from different materials, each having different wear characteristics, strength, elasticity, and/or durability. In one embodiment, the proximal body560may be made from a metal or a metal alloy and the distal body550may be made from a polymer, a Synthetic polyvinyl alcohol (PVA) hydrogel, a biomaterial, a biocompatible polymer such as PolyEther Ether Ketone (PEEK) or a polylactide polymer (e.g. PLLA), and/or others. The difference in attributes between the distal body550and the proximal body560may provide advantages in terms of cost, durability, wear, and/or the like.

FIG.6is a perspective side view of a system deployed on a foot joint according to another embodiment of the present disclosure.FIG.6illustrates an MTP joint250between a first proximal phalanx130and a first metatarsal110. In one embodiment, the first metatarsal110may include a bone tunnel340.FIG.6includes similar components, parts, devices, apparatus, features, and aspects as those disclosed and described in relation toFIG.3, however the difference inFIG.6is that the system uses an alternative embodiment of the implant.

FIG.6illustrates an implant600with a different configuration from the implant500. Patients may have a variety of conditions within the MTP joint250that can be addressed with embodiments of the present disclosure. In certain instances, a patient may present with an OCL that is smaller than the natural articular surface260. In other instances, the condition of the natural articular surface260may be such that the whole natural articular surface260needs to be resurfaced. The implant600can be used in these instances. Generally, the implant600may be sized and configured to cover and/or replace a natural articular surface260of a bone.

FIGS.7A-7Dillustrate a perspective view, a bottom view, a perspective side view, and a top view, respectively of an implant600according to one embodiment. The embodiment of these figures is but one example of a variety of different implants and/or implant configurations that can be used with the present disclosure. The implant600may include a body610, and edge620, and a connector630. The body610may include a joint-facing articular surface612and a posterior surface614. The posterior surface614may contact a resurfaced version of the natural articular surface260and may include a coating of an osseointegration material such as hydroxyapatite (HA) or other naturally occurring and biocompatible substances configured to promote osseointegration. The coating may result in the posterior surface614fusing with a resurfaced articular surface of the distal end190of the bone (e.g., first metatarsal110). The body610may be shaped such that the posterior surface614is concave and the joint-facing articular surface612is convex.

In certain embodiments, the implant600may include a lip616that extends from the body610. The lip616may connect to the body610and include a posterior surface and joint-facing surface that each match the contour of the respective, posterior surface614and joint-facing articular surface612. The lip616may serve to extend an articular surface of a bone such that the lip616serves as the articular surface of the bone when the joint is in flexion approaching approximately 90 degrees of flexion.

The connector630illustrates and alternative embodiment of connector530. However, the connector630may serve the same purpose as the connector530: to connect the implant600to a coupler such as a transosseous coupler320, a tether, a suture, or the like. In the illustrated embodiment, the connector630includes a plurality of openings634. In one embodiment, one end of a coupler can be threaded through one or more of the plurality of openings634to connect the coupler to the implant600.

FIGS.5A-5E,6, and7A-7Dillustrate at least three different embodiments for an implant that can be used within the scope of the present disclosure. Of course, various other embodiments are contemplated and come within the scope of the present disclosure as recited in the claims. For example, other embodiments may be of different diameters, different shape posterior surfaces, different shape anterior surfaces, different form, shape, configurations of transosseous couplers, and/or different form, shape, configurations of connectors, including no connector embodiments that include a transosseous coupler formed as an integrated part of the implant. In one embodiment, the diameter of the implant may be any diameter that matches or exceeds the diameter of one or more OCLs350in a joint of the patient. Consequently, the size of the implant can range from a size that covers the articular surface of the distal end190of the bone (e.g., implant600, also referred to as hemicap) to a button or plug size (e.g., implant500, also referred to as a spacer).

FIG.8is a perspective view of an arthroplasty implant system800for use on a foot joint according to one embodiment. The arthroplasty implant system800may include an arthroplasty implant810, a bone anchor820, and tether840. As used herein, an “arthroplasty procedure” refers to a surgical procedure for restoring and/or improving function and/or operation of a joint of a patient. An arthroplasty procedure can be done for a toe joint, ankle joint, knee joint, hip joint, arm joint, elbow joint, finger joint, or the like. In certain embodiments, an arthroplasty can include replacing, remodeling, resurfacing, or realigning an articular surface of a musculoskeletal joint by osteotomy or some other procedure. (Search “arthroplasty” on Wikipedia.com Jan. 14, 2022. CC-BY-SA 3.0 Modified. Accessed Jan. 14, 2022.) An arthroplasty procedure may be an elective procedure to relieve pain and/or restore function to a joint after damage by arthritis or some type of trauma. An “arthroplasty implant” is an implant used in an arthroplasty procedure.

The arthroplasty implant810is an implant configured to engage a distal articular surface860of a metatarsal bone816(See for exampleFIG.9). In certain embodiments, the arthroplasty implant810may be similar to and/or may function similar to the implant500described in herein. Alternatively, or in addition, the arthroplasty implant810may include distinct differences from the implant500. In the illustrated embodiment, the arthroplasty implant810includes a connector530like the connected in the implant500.

The bone anchor820may be a single unitary piece such as the example embodiment bone anchor330described in relation toFIG.2. Or, as in the illustrated embodiment, the bone anchor820may include two or more pieces. In the illustrated embodiment, the bone anchor820includes a body822having external threads824on an outside surface of the body822. The external threads824can be configured to engage with bone. In one embodiment, the external threads824may engage with an internal surface (e.g., walls) of a bone tunnel. In certain embodiments, the bone anchor820may be secured to the metatarsal bone816away from the distal articular surface860. For example, the bone anchor820may be secured within, onto, near, or around the dorsal surface210, the plantar surface220, the medial surface230, and/or the lateral surface240.

In one embodiment, the bone anchor820may sit within a bone tunnel of a bone of the patient. The bone anchor820may sit within a proximal opening of the bone tunnel. In one embodiment, the body822is a cylindrical body that includes a passage or opening826that extends from a proximal end828to a distal end830.

The bone anchor820may also include a tether locking feature832. As used herein, a “lock” or “lock mechanism” refers to an object, member, structure, component, part, apparatus, system, or assembly that either alone or in combination with other parts or components prevents, limits, impedes, is in a fixed relationship to, stops, or restricts motion or movement and/or operation of the another object, member, structure, component, part, apparatus, system, or assembly.

In one embodiment, the tether locking feature832is configured to implement line-lock device, either independently, or together with the body822. A line-lock device is a technology and/or apparatus that permits a suture, line, and/or tether to slide past the line-lock device in one direction, but the suture, line, and/or tether is impeded or restricted or locked from sliding past the line-lock device in another direction. To use the line-lock device, one end of a suture, line, and/or tether, such as tether840can be threaded through the line-lock device in one direction and as the tether840moves through the line-lock device the tether840is prevented from moving out of the line-lock device in the opposite direction. In this manner, a user can tighten the tether840using the tether locking feature832and/or body822and the tether840remains tight and/or taut.

The opening826may be configured to receive the tether locking feature832within the opening826and retain the tether locking feature832within the opening826. In one embodiment, the tether locking feature832and/or the opening826may be configured to engage with each other such that the tether locking feature832can sit within the opening826of a cylindrical body822. For example, the tether locking feature832and opening826may each have a polygon cross section sized for a slip fit between the tether locking feature832and the opening826. In certain embodiments, the tether locking feature832and opening826of the body822may cooperate to implement a line-lock device. Alternatively, or in addition, the tether locking feature832alone may implement the line-lock device. The tether locking feature832is configured to couple a proximal end of the tether840to the bone anchor820.

The tether840is configured to couple the arthroplasty implant810to the bone anchor820. In certain embodiments, the tether840may couple the arthroplasty implant810to a bone. The term “tether” is used herein to mean any strand or flexible member, natural or synthetic, able to join or connect or couple two structures. In one embodiment, a tether can join tissue of a patient and/or to be anchored in a bone tunnel or to hard tissue and useful in a surgical procedure. A tether may join two structures either directly by connecting directly to one structure or directly to the other or indirectly by connecting indirectly (by way of one or more intermediary structures) to one structure, to the other structure, or to both structures. In certain embodiments, “tether” refers to a flexible line or flexible member of natural material, natural biological material, biomaterial, biomimetic materials, manmade material, or a combination of these either in a single tether, a composite tether, or a plurality of tissue tethers that extend in parallel and/or may be woven or bonded together. In certain embodiments, a tether may be long and thin. In certain embodiments, a tether may be planar and/or may be elastic or inelastic (rigid). Examples of a tether include, but are not limited to, a thread, a string, a polymer thread or line, a suture, suture tape, a woven tether, a fibrous material, a cord, and/or any of these in combination with each other, and the like.

The tether840includes a proximal end842and a distal end844. In one embodiment, the proximal end842can be connected, coupled, joined, tied, or otherwise engaged with the bone anchor820and/or bone of a patient. The distal end844can be connected, coupled, joined, tied, or otherwise engaged with the arthroplasty implant810. In one embodiment, the distal end844may be tied to the connector530by passing the distal end844through the opening534and tying a knot near the distal end844. In another embodiment, the distal end844may be passed through the connector530(e.g., through the opening534and positioned near the proximal end842such that a loop engages the connector530. In such an embodiment, the proximal end842and distal end844may both be connected, coupled, joined, tied, or otherwise engaged with the bone anchor820. In certain embodiments, the tether840is flexible and can be stretched when tension is applied to tether840, for example, to the proximal end842and distal end844of the tether840.

FIG.9is a cross-section view of a distal end190of a metatarsal bone816according to one apparatus, system, and/or method of one embodiment of the present disclosure.FIG.9illustrates the metatarsal bone816and the first proximal phalanx130before components of the apparatus, system, or assembly of the present disclosure are deployed.

The metatarsal bone816includes a bone tunnel862and a bone pocket864. The bone tunnel862may be similar to the bone tunnel340described herein. In one embodiment, the bone tunnel862is cylindrical. The bone tunnel862may include a proximal end866(also referred to as a proximal opening) and a distal end868. In one embodiment, the proximal end866exits between a distal end190and a proximal end180of a bone. In the illustrated embodiment, the proximal end866may exit near a dorsal surface210of a metatarsal bone816. In certain embodiments, the distal end868may exit directly at, or onto, a distal articular surface860(e.g., a natural articular surface260) of the metatarsal bone816. In another embodiment, the distal end868may exit indirectly at, or onto, a distal articular surface860(e.g., a natural articular surface260) by way of a bone pocket864formed in the distal articular surface860(e.g., a natural articular surface260) of the metatarsal bone816. The distal end868may exit within the bone pocket864. The bone tunnel862may be formed using a surgical drill and drill bit. The length and diameter of the bone tunnel862can vary and may be similar to that of the bone tunnel340.

A bone pocket864is a type of opening or recess. A bone pocket864may be defined as a recess having a larger diameter than a bone tunnel862. The bone pocket864may extend proximally from the natural articular surface260into the bone.

In one embodiment, the bone tunnel862is cylindrical and the bone pocket864is semispherical, half spherical, circular, or the like. In one embodiment, the bone pocket864may be cylindrical. The bone pocket864may be formed in the natural articular surface260/distal articular surface860using a surgical reamer with a semispherical bit. The size and shape of the bone pocket864can vary based on similar characteristics to those for the bone tunnel862. The bone pocket864can have a diameter (e.g., a maximum diameter) that is slightly larger than the diameter of an implant500or arthroplasty implant810. A spherical bone tunnel862may not have a minimum diameter.

The bone tunnel862may extend from the bone pocket864at an angle. The length of the bone tunnel862and/or angle of the bone tunnel862within the bone pocket864may depend on a variety of factors including but not limited to, the size and location of the OCL350, the desired exit point for the proximal end866of the bone tunnel862, the size and depth of the bone pocket864, characteristics of the patient, and the like. The angle for the bone tunnel862may be measured relative to a long axis870of the metatarsal bone816. The angle may range from about negative 85 degrees and about positive 85 degrees.

In certain embodiments,FIG.9illustrates the bones of a joint after preparatory steps in a system, and/or method of one embodiment of the present disclosure. At the phase illustrated the metatarsal bone816includes a bone tunnel862and bone pocket864, each sized, positioned, and/or configured for deployment of members of the arthroplasty implant system800, as one example.

FIG.10is a cross-section view of a distal end190of a metatarsal bone816according to one apparatus, system, and/or method of one embodiment of the present disclosure.FIG.10illustrates a step in a method, process, or procedure of one embodiment of the present disclosure following preparatory step(s) illustrated in relation toFIG.9.FIG.10illustrates a body822of a bone anchor820deployed within a proximal end866of the bone tunnel862.

FIG.10also illustrates an articular implant900. An articular implant900is an implant configured for use on at least part of an articular surface such as the distal articular surface860of the metatarsal bone816. In the illustrated embodiment, the articular implant900may be configured similar to the arthroplasty implant810. A distal end844of the tether840may be coupled, connected, or tied to the articular implant900(e.g., by way of a first connector such as connector530, the first connector may be an opening in the articular implant900). The proximal end842of the tether840may be free.

A surgeon may pass a suture threader910through the bone tunnel862from the proximal end866to the distal end868and bone pocket864. The surgeon may thread the proximal end842through a loop in the suture threader910. Next, the surgeon may pull the suture threader910out of the bone tunnel862from the proximal end866and thereby pass the proximal end842of the tether840through the bone tunnel862.

FIG.11illustrates a result of a subsequent set of steps in the method or procedure in accordance with one embodiment of the present disclosure after steps described in relation toFIG.10.FIG.11illustrates that the surgeon has pulled the tether840through the bone tunnel862until the articular implant900is embedded into the bone pocket864of a distal articular surface860of the metatarsal bone816(e.g., a natural articular surface260).

In addition, the surgeon has coupled the tether840to the bone anchor820such that the bone pocket864retains the articular implant900in place during osseointegration of the articular implant900into the metatarsal bone816. In one embodiment, the surgeon may couple the tether840to the bone anchor820by engaging a tether locking feature832with the proximal end842of the tether840. The tether locking feature832may serve as a second connector coupled to the bone anchor820. In certain embodiments, the proximal end842may pass through the tether locking feature832and thereby tighten the tether840. The tether locking feature832may then be positioned within the body822of the bone anchor820.

Together the articular implant900, tether840, and bone anchor820cooperate to replace at least a portion of the distal articular surface860(e.g., a natural articular surface260). The articular implant900can serve as a spacer within a joint (e.g., an MTP joint250). “Spacer” refers to a mechanical device, apparatus, member, object, body, component, or structure, that is organized, configured, designed, arranged, or engineered to maintain a separation between two adjacent objects, surfaces, or structures. The articular implant900maintains separation between the distal articular surface860and the articular surface of an adjacent phalanx bone (e.g., first proximal phalanx130).

Advantageously, certain embodiments of the present disclosure provide fixation of the articular implant900within the joint as the bones and joint heal from a procedure. In certain embodiments, the fixation is temporary and/or adjunctive (or supplemental) to a permanent fixation as the bone fuses with the articular implant900as part of the healing process.

In certain embodiments, the articular implant900(e.g., its edge520and/or posterior surface514) and the surface of the bone pocket864may be configured to cooperate to provide fixation through a press-fit connection/interface between the bone pocket864and the articular implant900. Alternatively, or in addition, the articular implant900(e.g., its edge520and/or posterior surface514) and the surface of the bone pocket864may be configured to cooperate to provide fixation through a slip-fit connection/interface between the bone pocket864and the articular implant900. The slip-fit connection/interface may result from embedding the articular implant900in the distal articular surface860. The slip-fit connection/interface together with intrinsic compression from the joint reactive force when a surgeon reduces the MTP joint can serve to maintain the position of the articular implant900on the distal articular surface860.

Alternatively, or in addition, the tether840coupling the articular implant900to the bone anchor820may provide positive fixation with a constant tension that keeps the articular implant900in the bone pocket864and in position on the distal articular surface860. The bone anchor820secures a proximal end842of the tether840to the metatarsal bone816away from the bone pocket864.

This positive fixation from the tether840and bone anchor820can serve as adjunctive fixation once the procedure is complete. This adjunctive fixation may enable the patient to begin using the joint very soon after the procedure and can reduce the recovery time. As the patient heals, each of the members of the arthroplasty implant system800can be fused and/or integrated with the bone of the patient to provide permanent fixation. In certain embodiments, components of the arthroplasty implant system800may be made from bioabsorbable or resorbable materials, such that they may be partially or completely absorbed by the body of the patient. The adjunctive fixation can last beyond the life of the patient or may last long enough for the bone to heal and close the bone tunnel862and/or the bone pocket864.

In one embodiment, one or more surfaces of the articular implant900, tether840, and/or bone anchor820may be coated with a coating of an osseointegration material such as hydroxyapatite (HA) or other naturally occurring and/or biocompatible substances configured to promote osseointegration. “Osseointegration” refers to the direct structural and functional connection between living bone and the surface of an implant. Said another way, osseointegration is functional ankylosis (bone adherence), where new bone is laid down directly on an implant surface and the implant exhibits mechanical stability (i.e., resistance to destabilization by mechanical agitation or shear forces). Osseointegration is the formation of a direct interface between an implant and bone, without intervening soft tissue. (Search “osseointegration” on Wikipedia.com Sep. 15, 2021. Quoting other sources. CC-BY-SA 3.0 Modified. Accessed Jan. 21, 2022.)

In one embodiment, the tether840can be made from a bioabsorbable material such that the tether840may be partially, or completely, absorbed into the bone of a patient over time. Alternatively, or in addition, the articular implant900and bone anchor820may be partially or wholly osseointegrated into the bone. In this manner, the arthroplasty implant system800may become a permanent part of the joint and/or bone.

FIG.12is a cross-section view of an implant according to one embodiment.FIG.12illustrates an example implant500positioned within a bone pocket864. In the illustrated embodiment, the bone pocket864has a semispherical or hemispherical shape and has a bone radius measured from point1202with a constant radius R1. In one embodiment, R1may be between about 1.5 mm and about 3 mm, and may depend on the size of the implant500being used. For example, in one embodiment, the size of R2is substantially the same as the size of R1. R1and/or R2may be sized to be substantially half of the diameter of an OCL350that was present on the distal articular surface860before the bone pocket864was formed. In certain embodiments, the size of R1and/or R2may be slightly larger than half of the diameter of an OCL350that was present on the distal articular surface860before the bone pocket864was formed.

FIG.12illustrates that the posterior surface514is convex and the edge520is circular. The posterior surface514may be semispherical and the bone pocket864may be semispherical. In one embodiment, the posterior surface514may have a hemispherical shape with a constant radius R2from point1202. In one embodiment, R2may be substantially the same as R1. R2and R1being the same can ensure an even and constant interface between the posterior surface514and a surface of the bone pocket864. This interface retains the implant500within the bone pocket864.

In certain embodiments, R2is greater than R1. R2greater than R1may ensure that the joint-facing articular surface512will extend outside the bone pocket864making the joint-facing articular surface512prominent to the distal articular surface860. This enables the joint-facing articular surface512to serve as an articulation surface.

FIG.12also illustrates an articular implant500having a joint-facing articular surface512that is convex. The joint-facing articular surface512may have a radius R3measured from point1202that defines convex joint-facing articular surface512. R3and R2may be sized such that the joint-facing articular surface512is prominent and serves as a suitable replacement for at least a portion of the distal articular surface860. In one embodiment, the joint-facing articular surface512extends above the distal articular surface860by between about 1 mm to about 1.5 mm.

FIG.12illustrates a tether840that couples the implant500to a bone anchor820(SeeFIG.11) through a bone tunnel862that extends from the bone pocket864such that when the tether840couples the implant500to the bone anchor820at least a portion of the edge520contacts a surface of the bone pocket864below the distal articular surface860. The angle and trajectory of the bone tunnel862relative to the bone pocket864can be selected to maximize the fixation affect between the posterior surface514, edge520, and the surface of the bone pocket864. The angle of the bone tunnel862may apply an even tension on the implant500pressing the posterior surface514against the surface of the bone pocket864.

FIG.13is a cross-section view of an implant according to one embodiment.FIG.13illustrates an implant500with a body510having the joint-facing articular surface512, a convex posterior surface514, and an edge520between the joint-facing articular surface512and the convex posterior surface514. In certain embodiments, it may be desirable to have the edge520be prominent to the distal articular surface860. Said another way, the implant500and bone pocket864may be sized such that the edge520extends above the natural articular surface260of the bone. Furthermore, it may be desirable to have the edge520be prominent to (i.e., extend above) the distal articular surface860and below a surface of cartilage1302. In this manner, the edge520is contained within the cartilage1302.

FIG.13also illustrates that in the example embodiment, the implant500includes a joint-facing articular surface512that is convex and has a size and shape such that a top (marked by X1304) of the joint-facing articular surface512is congruent with or substantially congruent with cartilage1302and/or a surface of the cartilage1302. The top1304may be a geometric center of the joint-facing articular surface512. In another embodiment, the joint-facing articular surface512has a size and shape such that the top1304is below a surface of surrounding cartilage1302of the distal articular surface860and the edge520is below surface of surrounding cartilage1302.

FIG.14is a flow chart diagram of one example method1400for deploying an arthroplasty implant system according to one embodiment.FIGS.15A-15Fillustrate perspective cross-section views of different steps in an example method, such as method1400for deploying an arthroplasty implant system according to one embodiment. Referring toFIGS.8through15F, the method1400starts with a user, such as a surgeon, forming1402a bone pocket864in an articular surface of a metatarsal bone (e.g., distal articular surface860of metatarsal bone816), the bone pocket864is sized and positioned to resect at least one OCL350. A surgeon may distract the joint in order to provide access for forming the bone pocket864. In certain embodiments, the surgeon may start with a small bone pocket864and progressively increase the size of the bone pocket864until a sufficient amount of OCL350is removed.FIG.15Aillustrates one example after completion of the forming step1402.

Next, a surgeon, or other user, may form1404a bone tunnel862comprising a distal tunnel end (e.g., distal end868) and a proximal tunnel end (e.g., proximal end866), the bone tunnel862is configured such that the distal tunnel end connects the bone pocket864and the proximal tunnel end connects to an external surface of the metatarsal bone816. The position, length and trajectory of the bone tunnel862may vary based on a variety of factors and may be determined, at least in part, using a guide that may seat, index, or register on the bone pocket864.FIG.15Billustrates one example after completion of the forming step1404.

Next, a surgeon, or other user, may pass1406a tether840through the distal tunnel end (e.g., distal end868) and proximal tunnel end (e.g., proximal end866) of the bone tunnel862. In one embodiment, the surgeon may use a suture threader to pass the tether840from the distal tunnel end (e.g., distal end868) and proximal tunnel end (e.g., proximal end866) by pulling the tether840. The tether840may include a distal tether end and a proximal tether end. Of course, there are a variety of ways a surgeon may pass1406the tether840through the bone tunnel862each of which is within the scope of the present disclosure. For example, the tether840may be pushed from the distal tunnel end to the proximal tunnel end.

FIG.15Cillustrates one example as a surgeon is passing1406the tether840through the bone tunnel862. The surgeon has inserted a suture threader through the bone tunnel862. The proximal end842of the tether840has been passed through a loop in the suture threader such that withdrawing the suture threader from the bone tunnel862will pull the tether840through the bone tunnel862, as illustrated inFIG.15D.

In one embodiment in a next step in the method1400, a user may secure1408the distal tether end (e.g., distal end844) to the arthroplasty implant810.FIG.15Cillustrates that this step1408has been completed. Those of skill in the art will appreciate that step1408can be performed at various times and in a different order than the one described here. A user may secure1408the distal tether end to the arthroplasty implant810before a surgical procedure begins. Alternatively, a manufacturer may secure1408the distal tether end to the arthroplasty implant810.

FIG.15Calso illustrates that the body822may be deployed within the bone tunnel862. Those of skill in the art will appreciate that deployment of a bone anchor820or part of a bone anchor820may be performed at different times in the method1400. In the illustrated embodiment, the body822may be configured to receive the tether locking feature832.

In one embodiment in a next step in the method1400, a user may secure1410the proximal tether end within the bone tunnel862. In one embodiment, the user may couple the distal end844of the tether840to a tether locking feature832and hold the tether840tight while moving the tether locking feature832along the tether840in the direction of arrow1502. This action may tighten the tether840and introduce tension between the arthroplasty implant810and the bone anchor820(body822and tether locking feature832). The user may then seat the tether locking feature832in the body822to secure1410the tether840to the metatarsal bone816. One example of step1410is shown inFIG.15E.

Step1410may complete the method1400.FIG.15Fillustrates one example of the arthroplasty implant system800successfully deployed in the metatarsal bone816.

In certain embodiments, after a successful deployment of arthroplasty implant system800, a user may desire a revision procedure. For example, the arthroplasty implant system800may have performed without any problems, however the condition of the MTP joint250may have deteriorated. “Revision procedure” refers to a surgical procedure in which the procedure's purpose is to change an aspect of a prior surgical procedure. A revision procedure may be performed to address infection, disease, a complication, or for a variety of other reasons.

In one embodiment, cartilage1302around the arthroplasty implant810may have developed one or more OCLs350. During such a revision procedure a surgeon can ream the arthroplasty implant810out of the bone pocket864and/or resize the bone pocket864to a size that supports a second arthroplasty implant that has a greater diameter than the arthroplasty implant810. The surgeon may restore the bone tunnel862, for example, by using a surgical drill and bit. Next, the surgeon may pass a second tether through the restored bone tunnel, secure a distal tether end of the second tether to the second arthroplasty implant, and secure a proximal tether end of the second tether within the restored bone tunnel as part of the revision procedure.

FIGS.16A-16Dis a perspective view, bottom view, perspective side view, and top view, respectively of an implant1600according to one embodiment. The embodiment of these figures is but one example of a variety of different implants and/or implant configurations that can be used with the present disclosure.

The body1610may resemble a button or plug. In one embodiment, the body1610has a circular cross section. The body1610may include a joint-facing articular surface1612and a posterior surface1614. The joint-facing articular surface1612may be a part of the implant1600that generally faces the joint. The joint-facing articular surface1612may be convex and meet the posterior surface1614at a shoulder1618. The convex shape of the joint-facing articular surface1612may be configured to simulate or emulate the shape and contour of a natural articular surface of a joint. Furthermore, the convex shape may distribute loading during use of the joint from an apex1616of the joint-facing articular surface1612down and out towards the shoulder1618.

The joint-facing articular surface1612can have a variety of shapes and configurations. In one embodiment, the joint-facing articular surface1612may be generally flat. In another embodiment, the joint-facing articular surface1612may have a contour configured to facilitate articulation with a natural articular surface of an adjacent bone.

In one embodiment, the posterior surface1614is shaped to engage with a distal articular surface (e.g., natural articular surface260) of a bone. In one embodiment, a posterior surface1614may be configured to seat within a bone pocket864(seeFIG.17).

The posterior surface1614may be shaped to engage with the distal articular surface by way of a bone pocket formed in the distal articular surface. In one example, the bone pocket may be concave shaped and the posterior surface1614may be convex shaped to match or substantially match the concave shape of the bone pocket. A concave bone pocket and convex posterior surface1614can enable the body1610to seat within the bone pocket when deployed.

In one embodiment, the posterior surface1614may engage a surface of a bone pocket and a shoulder1618may engage a surface of a natural articular surface of the bone that includes the bone pocket.

In one embodiment, the shoulder1618is a structure between the joint-facing articular surface1512and the posterior surface1614. The shoulder1618can serve to prevent or mitigate movement of the implant1600further into the bone pocket or other features of the bone once deployed. Forces acting to move the implant1600into the bone, bone features, and/or the bone pocket include but are not limited to pressure against the joint-facing articular surface1512during movement of the joint and tension from a tether or other coupler that connects the implant1600to a bone anchor.

In certain embodiments, a shoulder may be a type of a two dimensional edge that joins two adjacent structures or surfaces. In certain embodiments, the shoulder1618may be at a perimeter of the implant1600. In one embodiment, the shoulder1618circumscribes the body1610. In the illustrated embodiment, the implant1600may include a single shoulder1618that may have a circular cross-section. Those of skill in the art will appreciate that the implant1600can include one or more shoulders1618and/or a single shoulder1618can include one or more cutouts around its perimeter.

In the illustrated embodiment, the shoulder1618includes a contact surface1619and an edge1620. The contact surface1619may be configured to directly contact a surface of the natural articular surface (e.g., surface860inFIG.17) of the bone when the implant1600is positioned within a bone socket864and/or secured to a bone anchor, for example by way of a bone tunnel862. The edge1620may be planar or come to a point around the shoulder1618. A pointed edge1620may be advantageous in positioning the edge120between cartilage of the natural articular surface and the natural articular surface.

In certain embodiments, the implant1600may include a connector1630. In the illustrated embodiment, the connector1630includes cut outs1632a,band an opening1634. The cut outs1632a,bmay facilitate aligning a coupler (e.g., a transosseous coupler320) with a center of the implant1600. Those of skill in the art will recognize that the cut outs1632a,bmay be optional and may or may not be included in an embodiment. The opening1634may engage with the coupler to couple the implant1600and the coupler. In the illustrated embodiment, the opening1634extends from one cut out1632ato an opposite cut out1632b. In one embodiment, the coupler may be a tether and the connector1630engages with the tether and secures the implant1600to the tether. For example, one end of a tether may be passed through opening1634and the tether may be tied into a knot to secure the tether to the implant1600.

FIG.17is a cross-section view of an implant according to one embodiment.FIG.17illustrates an example implant1600positioned within a bone pocket864. In the illustrated embodiment, the bone pocket864has a semispherical or hemispherical shape.FIG.17illustrates a convex joint-facing articular surface1612, a convex posterior surface1614, and a shoulder1618that circumscribes the body1610.

FIG.17illustrates a tether840that couples the implant1600to a bone anchor820(SeeFIG.11) through a bone tunnel862that extends from the bone pocket864. The angle and trajectory of the bone tunnel862relative to the bone pocket864can be selected to maximize the fixation affect between the posterior surface1614, shoulder1618, and the surface860of the bone. The angle of the bone tunnel862together with the tether may apply an even tension on the implant1600pressing the posterior surface1614against the surface of the bone pocket864and the contact surface1619of the shoulder1618against the natural articular surface860.

Advantageously, a shoulder1618can serve to prevent the implant1600from subsiding deeper into the cortex of the natural articular surface and/or bone. For example, in certain instances, bone material around a bone tunnel862may be weaker bone and tension on a tether840may cause the implant1600to subside into the bone tunnel862. Alternatively, or in addition, the implant1600and a bone tunnel862may positioned near, or transverse to, an intramedullary canal of the bone (e.g., a first metatarsal110) the shoulder1618can prevent the implant1600from subsiding or slipping into the intramedullary canal after deployment.

Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects can exist alone and/or in a combination of fewer than all, or all, features of any single embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.

While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the scope of this disclosure is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present disclosure set forth herein without departing from it spirit and scope.

Those of skill in the art will appreciate that the solutions provided in present disclosure may be accomplished with all, or less than all, of the components, structures, features, or aspects disclosed in the specification or illustrated in the figures in relation or a particular embodiment or claim.