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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. |
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In certain embodiments, the implant 310 and/or the joint-facing articular surface 312 may be a structure different from a rigid structure. For example, in one embodiment, the joint-facing articular surface 312 may 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 implant 310 embodied as a suture ball may have less coefficient of friction than an implant 310 with a rigid joint-facing articular surface 312. Further, implant 310 embodied as a suture ball may be softer than an implant 310 with a rigid joint-facing articular surface 312. |
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Orthopedic implants can be used to treat bone fractures, osteoarthritis, scoliosis, spinal stenosis, discomfort, and pain. Examples of orthopedic implants include, but are not limited to, a wide variety of pins, rods, screws, anchors, spacers, sutures, all-suture implants, ball all-suture implants, self-locking suture implants, cross-threaded suture implants, plates used to anchor fractured bones while the bones heal or fuse together, and the like. (Search "implant (medicine)" on Wikipedia.com May 26, 2021. CC-BY-SA 3.0 Modified. Accessed June 30, 2021.) |
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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. |
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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. |
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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. |
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FIGS. 15A-15F illustrate perspective cross-section views of different steps in an example method for deploying an arthroplasty implant system according to one embodiment. |
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FIG. 14 is a flow chart diagram of one example method for deploying an arthroplasty implant system according to one embodiment. |
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FIG. 13 is a cross-section view of an implant according to one embodiment. |
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FIG. 12 is a cross-section view of an implant according to one embodiment. |
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FIG. 3 is a perspective side view of the system of FIG. 2 deployed on a foot joint according to one embodiment. FIG. 3 illustrates an MTP joint 250 between a first proximal phalanx 130 and a first metatarsal 110. In one embodiment, the first metatarsal 110 may include a bone tunnel 340. The bone tunnel 340 may include a proximal end 342 and a distal end 344. |
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In the illustrated embodiment, the implant 500 is a solid structure that includes a body 510 and an edge 520. 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. |
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FIGS. 5A-5D is a perspective view, bottom view, perspective side view, and top view, respectively of an implant 500 according 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. |
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For example, a surgeon may select a size of implant 310 with a diameter D3 (the diameter of the joint-facing articular surface 312) that is smaller than the diameter D2 of the natural articular surface 260 of the bone and greater than a diameter D1, or width, of the OCL 350. The diameter D3 of the implant 310 may maintain a 1-2mm gap between the joint-facing articular surface 312 and an edge of the natural articular surface 260. The system 300, when deployed, results in minimal bone removal. Retaining bone on the natural articular surface 260 can 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. |
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Advantageously, the OCL 350 may have a diameter D1 that is smaller than a diameter D2 of the natural articular surface 260. In certain embodiments, the system 300 can be used to treat the OCL 350 such that a minimal amount of bone and/or soft tissue of the natural articular surface 260 is removed for the procedure. |
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FIG. 4 is an anterior view of a natural articular surface of a bone. The bone may be a first metatarsal 110 and the natural articular surface maybe the natural articular surface 260 of the head of the first metatarsal 110. In this example, the natural articular surface 260 includes 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.) |
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FIG. 3 illustrates one embodiment in which the bone anchor 330 resides proximate to the another surface (e.g., dorsal surface 210) and is separated from the natural articular surface 260 by the bone tunnel 340. The bone anchor 330 may be of a number of different varieties. In one embodiment, the bone anchor 330 is an interference screw that seats within the proximal end 342. The interference screw may secure a free end of the transosseous coupler 320 to an inside wall of the bone tunnel 340. The bone anchor 330 couples the transosseous coupler 320 to the bone (e.g., first metatarsal 110) such that the transosseous coupler 320 retains the implant 310 in place on the natural articular surface 260. Once deployed the transosseous coupler 320 applies tension on the implant 310. The tension is applied in the direction of the bone anchor 330. The tension holds the joint-facing articular surface 312 in place on the distal end 190 of the bone (e.g., first metatarsal 110). In certain embodiments, the tension provides provisional, adjunctive, or temporary fixation until the bone heals and osseointegrates the implant 310 into the bone. |
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Furthermore, the another surface for the proximal end 342 to exit can vary based on similar factors, including surgeon preference. Having the proximal end 342 exit at, or near the dorsal surface 210 may be advantageous because this location may facilitate access by a surgeon for the procedure. In addition, the bone tunnel 340 may be positioned proximal to or through a physes or epiphyseal plate such that bone growth that closes the bone tunnel 340 after the procedure and during healing may be rapid and complete. In this manner, the system 300 serves as provisional, adjunctive, or temporary fixation until the bone heals and osseointegrates the implant 310 into the bone. |
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In one embodiment, the bone tunnel 340 extends from the natural articular surface 260 of a bone, such as a first metatarsal 110, to another surface of the bone. The another surface can be one of the dorsal surface 210, the plantar surface 220, the medial surface 230, and/or the lateral surface 240 (not shown in FIG. 3). The proximal end 342 may exit at, or near, the another surface. In the illustrated embodiment, the proximal end 342 exits at, or near, the dorsal surface 210. The distal end 344 may exit directly on the natural articular surface 260. In another embodiment, the distal end 344 may exit indirectly onto the natural articular surface 260 by 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 tunnel 340 can 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. |
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The bone tunnel 340 may 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.” |
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