Stemless Semi-Constrained Implantable Joint Replacement Device

Abstract

Stemless, semi-constrained, implantable interphalangeal joint replacement device and method for use.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. §119(e) of U.S. Application No. 63 / 326,479, filed April 1, 2022, and U.S. Application No. 63 / 352,314, filed June 15, 2022, which are incorporated by reference in their entireties herein. [Background technology]

[0002] Arthritis of the interphalangeal joints resulting from osteoarthritis, rheumatoid arthritis, and traumatic injuries affect nearly 20 million Americans over the age of 45. For example, in osteoarthritis, degeneration of the joint can lead to bone-on-bone contact, which is a common cause of severe pain in the advanced stages of all forms of arthritis. Bone-on-bone contact leads to inefficient joint mechanics, which can impair the range of motion of the finger, accelerate the degenerative process, and ultimately lead to ankylosis or complete loss of motion in the joint. However, due to technical complexity and perceived market size, arthroplasty of the interphalangeal joints lags far behind arthroplasty of the hip, knee, and shoulder. The present invention provides a solution to meet the domestic market needs of over 1.2 million hand arthroplasty procedures per year, conservatively estimated, with a demand for the replacement of roughly 1.4 joints per procedure. The interphalangeal joints and other small joints of the foot in the human body and in veterinary patients represent a secondary market that may be pursued. This technology opens up the possibility of use in large joint arthroplasty, and also in non-human robotic and prosthetic joint systems.

[0003] Currently available solutions for chronic pain and stiffness in the interphalangeal joints of the hand include arthroplasty (also known as joint replacement surgery) or fusion of the joint.

[0004] Fusion is a surgical treatment in which portions of the opposing cartilaginous surfaces of adjacent phalanges in a finger are removed and then prepared bones are fitted together in a pre-specified location so that the bones will fuse together into a stable and pain-free single bony unit. Due to the lack of durable and reliable arthroplasty alternatives, fusion is a widespread treatment for chronic pain in the interphalangeal joints of the hand, resulting in permanent functional loss of movement in the joint.

[0005] As an alternative to fusion, one arthroplasty solution is the simple silicone hinge joint replacement device, which was developed in the 1960s and is still in common use today. This solution includes a one-piece axial hinge formed from silicone in the shape of a flexible central node with longitudinal stems facing the proximal and distal aspects of the central node. This configuration constrains flexion and extension along the sagittal axis of the finger. In some cases, a metal reinforcing plate (grommet) is integrated at the junction of the hinge node and stem for additional support in this high stress area within the device.

[0006] Insertion of a silicone hinge joint replacement device can be through a dorsal, lateral, or palmar approach, but typically involves a longitudinal incision on the dorsal aspect of the finger. This common dorsal approach requires surgical disruption of the extensor mechanism to allow for bone preparation. Preparation of the bone to receive the implant stem involves removal of a portion of the condyle head and sequential broaching of the medullary canals of the proximal and middle phalanges to provide space for the implant stem. Because the silicone hinge joint replacement implant is one piece and not modular, this procedure is a suitable option for patients with ligament deficiencies.

[0007] Another arthroplasty approach uses one of several types of unconstrained surface replacement devices with an individual proximal component and a separate distal component. Typical materials used for unconstrained multicomponent arthroplasty include pyrolytic carbon and biocompatible ceramics. The proximal component head roughly replicates the intercondylar groove formation of a bicondylar joint, and the distal component roughly replicates the interface intercondylar ridge that slides loosely in the groove of the opposing condyle. The unconstrained surface replacement option is appropriate for patients with strong ligamentous support to preserve the connection between the condylar groove and ridge. Good bone density and sufficient girth dimensions as well as high quality soft tissue are required for reliable implantation.

[0008] Alternatively, another approach for non-constrained resurfacing arthroplasty can use a stemless system that includes a proximal head and a distal base that are held in place using shallow pins, the natural osseointegration of biocompatible materials, and compression maintained by the patient's ligament and tendon structures. The stemless resurfacing option is appropriate for patients with good bone stock and strong ligamentous support.

[0009] In patients with loss or damage to one articular surface with preservation of the other, modular subarticular arthroplasty devices can be used to reconstruct one half of the joint. This technique is called hemiarthroplasty and can be used to resurface either the head of the proximal phalanx or the base of the middle phalanx.

[0010] There are several significant problems and disadvantages associated with the conventional devices described above.

[0011] Constrained silicone hinge joint replacement devices are not designed to approximate physiological motion and therefore consistently fail in their ability to deliver predictable motion outcomes. Other disadvantages of this stemmed one-piece device include implant loosening, implant dislocation, implant breakage / silicone fragmentation, osteolysis and erosion through bone, and collagen encapsulation of the implant, which can further limit range of motion. Revision of the device to address failure or dissatisfaction is difficult due to osteolytic changes caused by the unnatural forces imparted by the implant. Moreover, complications associated with failed revisions can lead patients down the amputation path.

[0012] Because non-constrained resurfacing arthroplasty (SRA) implants have two separate components, joint stability depends on the implant geometry and the surrounding soft tissue, which makes this solution susceptible to dislocation and instability. Creaking or other sounds resulting from direct contact between the components are common pathologies. Implant loosening, osteolysis, and erosion through the bone along the stem axis are also common modes of failure for these devices. Moreover, stemmed multi-component resurfacing is not recommended for patients with ligament deficiencies, extensor tendon injuries, or poor bone stock. As with constrained silicone implants, revision in the setting of failure or dissatisfaction is often difficult due to bone loss or weakening, and complications associated with failed revisions can ultimately lead to amputation.

[0013] Successful outcomes with stemless multicomponent options are highly dependent on healthy soft tissue structures and therefore contraindicated in patients with ligament deficiencies or extensor tendon injuries. However, revision options are more forgiving because stemless device implantation requires little bone preparation, thus sparing the phalanges from resection and unnatural stresses. Typically, sufficient bone remains after extraction of a failed or failing device to allow revision of the remaining bone to accommodate replacement or to perform a successful union procedure, in lieu of amputation.

[0014] With all currently available interphalangeal arthroplasty devices, stiffness and unpredictable motion outcomes remain major drawbacks. This may be due to a lack of surrounding soft tissue, the proximity of the surgical incision to the joint, or postoperative scarring, which often limits joint mobility through the accumulation of fibrous tissue and interference with tendon function. In addition, prolonged immobilization, often used by surgeons to allow postoperative soft tissue healing, may result in stiffness, tendon adhesions, and / or extension contractures, thus limiting the patient's ability to regain meaningful motion.

[0015] As a result of these problems, current implantable devices and surgical procedures often fail to predictably restore the range of motion expected by the patient or desired by the surgeon. The failure rate of current devices on the market remains unacceptably high. Thus, fusion has long been considered the first solution for pain relief and finger stability, regardless of its significant and permanent functional consequences.

[0016] Given the lack of reliable and effective alternative implant options, disability and stiffness in injured or diseased finger joints is currently expected and accepted. [Prior art documents] [Patent documents]

[0017] [Patent Document 1] U.S. Patent No. 10,610,347 [Patent Document 2] US Patent Application Publication No. 2020 / 0149145 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0231511 Summary of the Invention [Means for solving the problem]

[0018] The presently disclosed invention addresses the above-mentioned problems and disadvantages of currently available treatments by providing a stemless, semi-constrained, implantable interphalangeal joint replacement device and a surgical method for implanting same. The present disclosure provides a stemless implantable device for joint arthroplasty, the device including a flexible connector; optionally including a proximal transverse fixation system; optionally including a distal transverse fixation system, the flexible connector being attached at one end to the proximal fixation system and at the other end to the distal fixation system. The present disclosure provides a stemless implantable device for joint arthroplasty, the proximal transverse fixation system including a smooth or barbed rod. The present disclosure provides a stemless implantable device for joint arthroplasty, the distal transverse fixation system including a smooth or barbed rod. The present disclosure provides a stemless implantable device for joint arthroplasty, the proximal transverse fixation system and / or the distal transverse fixation system are identical. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the proximal and / or distal transverse fixation systems are different. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the proximal and / or distal fixation systems, independently or simultaneously, comprise a solid or hollow cylinder made of a biocompatible material. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the proximal and / or distal fixation systems, independently or simultaneously, comprise a biocompatible material selected from the group consisting of medical grade plastic, bioactive material, carbon nanofiber, carbon plate, carbon strip, ceramic, composite material, hydroxyapatite (HA) coating, nickel-free superelastic metal alloy, polyetheretherketone (PEEK), silicone, stainless steel, titanium alloy, titanium, ultra-high molecular weight polyethylene (UHMWPE), other materials capable of promoting bone regeneration or materials derived therefrom, and combinations thereof.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, comprise a material that promotes bone regeneration.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, comprise a material that promotes bone regeneration selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, ceramics, composites, hydroxyapatite (HA) coatings, nickel-free superelastic metal alloys, polyetheretherketone (PEEK), silicone, stainless steel, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), other materials capable of promoting bone regeneration or materials derived therefrom, and combinations thereof.

[0019] The present disclosure provides a stemless implantable device for joint arthroplasty, in which the proximal fixation system and / or the distal fixation system are independently or simultaneously mounted in bone using any fixation method. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the proximal fixation system and / or the distal fixation system are independently or simultaneously mounted in bone directly without a rod or sleeve. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the proximal fixation system and / or the distal fixation system are independently or simultaneously mounted in bone using a fixation method selected from the group consisting of cemented, uncemented, osseointegrated, osseointegrated with surface treatment or patterning to enhance bone ingrowth, press-fit, threaded, fluted, capped, screw-capped, pinned, other locking systems, and combinations thereof. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, include surface patterning to enhance natural bone ingrowth for anchoring into bone. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, include a plurality of individual barbs of sufficient quantity and placement to impart stability in the patient's cancellous bone. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, include barbs that are configured and manufactured to break away under specific controlled mechanical action. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, include concentric fluting.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, further include concentric fluting, the fluting being pitched in the direction of insertion to prevent dislocation in the direction of extraction.

[0020] The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, include a cannulated anchor including a hollow shaft and a slot, the slot being wide enough to allow both a first barrel shape at a proximal edge of the flexible connector and a second barrel shape at a distal edge of the flexible connector to pass through the slot and into a joint cavity; whereby the flexible connector is secured within a hollow shaft incorporating a thickened first barrel shape at a proximal edge of the flexible connector and a thickened second barrel shape at a distal edge of the flexible connector. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, includes a cannulated anchor including a hollow shaft and a slot, the slot being wide enough to allow both a first barrel shape at a proximal edge of a flexible connector and a second barrel shape at a distal edge of the flexible connector to pass through the slot and into a joint cavity; whereby the flexible connector is secured within a hollow shaft incorporating a thickened configured first barrel shape at a proximal edge of the flexible connector and a thickened configured second barrel shape at a distal edge of the flexible connector, and the proximal fixation system and / or the distal fixation system, independently or simultaneously, includes a crimping flange, a wide flange screw, a magnetic material, a biometric monitoring capability, and / or a bone scaffold integration.

[0021] The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, includes a rod attached to a flexible connector by a cannulated screw anchor with a longitudinal slot with an arc opening of approximately 0.2 radians. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, includes a rod attached to a flexible connector comprising a hollow cylinder with an arc opening of approximately 0.2 radians and with flanges that are generally parallel to one another and protrude from the cylinder edges, the flanges configured to secure the flexible connector within the cross-sectional profile of the hollow cylinder. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, includes a maximum length that does not exceed an intracortical dimension measured in the coronal plane of the patient's bone at the site of implantation. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal and / or distal fixation systems, independently or simultaneously, include a maximum dimension measured in the sagittal plane that is not more than approximately 70% of the bone dimension measured in the sagittal plane at the site of implantation in the patient after sectioning or debridement, allowing sufficient remaining bone to prevent bone fracture under normal force loading. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal and / or distal fixation systems, independently or simultaneously, include one or more crimping flanges for attaching a proximal and / or distal fixation rod to the flexible connector. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal and / or distal fixation systems, independently or simultaneously, include an osseointegrated surface treatment.The present disclosure provides a stemless implantable device for joint arthroplasty, where the flexible connector is attached directly into the prepared bone.The present disclosure provides a stemless implantable device for joint arthroplasty, where the flexible connector is attached into the bone using a rod and sleeve, attached into the bone using an anchor, and / or attached into the bone using a cannulated anchor.

[0022] The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system includes an anchor device configured with any shape selected from the group consisting of smooth, barbed, breakaway barbed, threaded screws, threaded screws with various pitches, threaded screws with various head types, threaded screws with various shank diameters, threaded screws with various thread diameters, threaded screws with various tip and crest profiles, threaded screws with various thread angles, concave fluting, concentric fluting, pitched fluting, longitudinal fluting, caps mechanically fastened to cortical bone using screws or pins, screw caps, hinged caps, cufflink caps, magnetic caps, osseointegrated bone caps, and combinations thereof, wherein the anchor device is configured to engage the cortical bone only at an implantation surface or additionally engages the cortical bone at an opposing end of the anchor device. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using an anchor.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using a cannulated anchor.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using a cannulated anchor, the cannulated anchor further comprising a wide flange screw to maximize contact surface area with the bone into which the cannulated anchor is inserted.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to the bone using a cannulated anchor, the cannulated anchor being constructed from a biocompatible material selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, ceramics, composites, hydroxyapatite (HA) coatings, nickel-free superelastic metal alloys, polyetheretherketone (PEEK), silicone, stainless steel, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), other materials capable of promoting bone regeneration or materials derived therefrom, and combinations thereof.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to the bone using a cannulated anchor, the cannulated anchor having a crystalline surface treatment to promote osseointegration of the anchor in cancellous bone. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to the bone using a cannulated anchor, the cannulated anchor having a varying pitch and / or a varying diameter. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to the bone using an anchor, the anchor being a cap that is mechanically fastened to the cortical bone to prevent lateral migration. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to the bone using an anchor, the anchor including an osseointegrated cortical bone cap. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to the bone using an anchor, the anchor including bone material that is seated in a cortical divot flush with the surface of the cortical bone above the rod head after insertion of the flexible connector into both anchor rods.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using an anchor, the anchor being a temporary fixation of the cortical bone cap using a biodegradable material that is dimensionally larger than the cortical bone cap that is mechanically fastened to the adjacent stable cortical bone to secure the cortical bone cap until osseointegration is achieved.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using an anchor, the anchor being a wide flange cap that is screwed or locked into the head of an anchor rod and mechanically fastened to the cortical bone using a screw.

[0023] The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation system and / or the distal fixation system, independently or simultaneously, are attached to bone using anchors, which are flexible connectors that are directly press-fitted into bone. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using anchors, which are flexible connectors that include an expanding hydrogel composite that is directly press-fitted into bone. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using anchors, which are flexible connectors that are directly press-fitted into bone with an expanding hydrogel composite, which increases stability as the expanding hydrogel composite hardens. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using anchors, which are made of a magnetic material. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using an anchor, the anchor having biometric monitoring capabilities.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using an anchor, the anchor including bone scaffold integration.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is attached to bone using an anchor, the anchor including barbs configured to break away in response to application of a specific controlled mechanical action.

[0024] The present disclosure provides a stemless implantable device for joint arthroplasty, the device further comprising a first integrally woven sleeve at a proximal end of the flexible connector for receiving and holding a proximal fixation rod and a second integrally woven sleeve at a distal end of the flexible connector for receiving and holding a distal fixation rod. The present disclosure provides a stemless implantable device for joint arthroplasty, the first integrally woven sleeve and the second integrally woven sleeve are barbed, independently or simultaneously. The present disclosure provides a stemless implantable device for joint arthroplasty, the proximal fixation rod and / or the distal fixation rod are barbed, independently or simultaneously. The present disclosure provides a stemless implantable device for joint arthroplasty, the first integrally woven sleeve and the second integrally woven sleeve are smooth, independently or simultaneously. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation rod and / or the distal fixation rod are, independently or simultaneously, smooth.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the proximal fixation rod and / or the distal fixation rod, independently or simultaneously, further comprise an anti-pullout peg.The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector comprises a fatigue resistant biocompatible material. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector comprises a fatigue resistant biocompatible material selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, composite materials, elastomeric polymers, hydroxyapatite (HA) coatings, nickel-free superelastic metal alloys, nitinol, internal shape memory alloys, polyetheretherketone (PEEK), silicone, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), engineered polymers, or materials derived therefrom, and combinations thereof.

[0025] The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector comprises a fatigue-resistant biocompatible material, the fatigue-resistant biocompatible material being braided nanofiber elements woven in a two-dimensional and / or three-dimensional array. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector incorporates a range of strengths, flexibility, elasticity, and other material properties to optimize the path of motion of the patient's phalanges and the durability of the device. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is constructed from a material configured to remain malleable after implantation. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the device further comprises a malleable material between the anchor and the flexible connector. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is in a kit that includes standard various angled implants for correcting anchor misalignment. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector includes a flexible material that allows smooth bending within the normal range of zero degrees to one hundred degrees (0-100 degrees) when activated by the patient's flexor tendon system.

[0026] The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector is a flexible, planar component constructed from a fatigue-resistant biocompatible material configured to allow motion of the joint in the sagittal plane when activated by the patient's flexor tendon system. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector is a flexible, planar component constructed from a fatigue-resistant biocompatible material configured to allow constrained accessory motion when subjected to an external force, such as when used to assist in gripping an oddly shaped object. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the width of the flexible connector does not exceed the intracortical dimension measured in the coronal plane of the patient's bone at the site of implantation. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector is designed such that the path of motion in the sagittal plane follows an arc path described by a normal interphalangeal joint or an approximation thereof. The present disclosure provides a stemless implantable device for joint arthroplasty, where the flexible connector is designed to limit movement in the coronal plane to a maximum of about 0 degrees of accessory movement.The present disclosure provides a stemless implantable device for joint arthroplasty, where the flexible connector includes woven or laminated components to create a flexible mesh with various dynamic qualities and fixation methods.The present disclosure provides a stemless implantable device for joint arthroplasty, where the flexible connector includes woven or laminated components to create a flexible mesh with various dynamic qualities and fixation methods, and is secured to the bones of the first and second phalanges using a fixation system comprised of rod pockets or sleeves, which are integrally woven into the proximal and distal edges of the flexible connector.

[0027] The present disclosure provides a stemless implantable device for joint arthroplasty in which the flexible connector maintains proper joint spacing to prevent bone-to-bone contact of the articular surfaces of the first and second bones of the joint. The present disclosure provides a stemless implantable device for joint arthroplasty in which the flexible connector is constructed using a plain weave and a wide cross-sectional profile for the warp components running perpendicular to the fixation pins or rods in the implant device to achieve a spring mesh that imparts lateral stability and alignment in the coronal plane without relying on articular ligaments. The present disclosure provides a stemless implantable device for joint arthroplasty in which the flexible connector is constructed using a weave pattern that changes length when tension is applied. The present disclosure provides a stemless implantable device for joint arthroplasty in which the flexible connector includes a spring mesh constructed using a bias weave of wide flat sections. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector comprises a unitary flexible having a plurality of weave patterns, laminations, or polymer curing formulae. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector comprises a fatigue resistant biocompatible material further comprising braided nanofiber elements. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector comprises an internal shape memory alloy. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector comprises an internal shape memory alloy comprising Nitinol. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector comprises an internal reinforcing textile matrix. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector comprises braided nanofiber elements woven in a two-dimensional array. The present disclosure provides a stemless implantable device for joint arthroplasty in which a flexible connector comprises braided nanofiber elements woven in a three-dimensional array.The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector comprises a fiber diameter or cross-sectional profile specified to deliver an appropriate Young's modulus of elasticity to the weave pattern to allow for a stretch capacity in bending of approximately 25% of the unbent mesh length. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector is constructed using an engineered polymer. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector comprises a polymer configured to allow translational and stretching movements that approximate the natural physiological motion of the interphalangeal joint. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the polymer is silicone. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector comprises silicone printed with an engineered pattern to improve the response of the flexible connector to stress. The present disclosure provides a stemless implantable device for joint arthroplasty, where the flexible connector comprises silicone printed with graduated density, such that the flexible connector comprises a higher density in or near the fixation system and a lower density in different parts of the flexible connector where greater flexibility is required to achieve a desired trajectory path of motion.The present disclosure provides a stemless implantable device for joint arthroplasty, where the flexible connector is a polymeric connector and includes a bumper flange oriented in a perpendicular manner relative to a coronal surface of the polymeric connector to prevent bone-to-bone contact.The present disclosure provides a stemless implantable device for joint arthroplasty, where the flexible connector is a polymeric connector and includes a bumper flange oriented in a perpendicular manner relative to a coronal surface of the polymeric connector to prevent bone-to-bone contact, and further, where the bumper flange is gel filled to enable dynamic response under various tensile and compressive conditions.

[0028] The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector is a polymeric connector, the polymeric connector includes a bumper flange oriented in a perpendicular manner relative to the coronal surface of the polymeric connector to prevent bone-to-bone contact, and further wherein the bumper flange includes a hollow or gel-filled portion to allow translation of a second bone relative to a first bone along an arc of motion. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector includes a biocompatible material that is fatigue resistant, the fatigue resistant biocompatible material including at least two different thicknesses. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector includes a fatigue resistant biocompatible material including at least two different widths. The present disclosure provides a stemless implantable device for joint arthroplasty, wherein the flexible connector includes a fatigue resistant biocompatible material further including braided nanofiber elements. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector comprises a fatigue resistant material formed into a thickened configured barrel shape at its proximal and distal edges. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector comprises a fatigue resistant biocompatible material configured to bend along a predetermined path when stressed by an externally applied bending force and further configured to return to a straight position when released from said externally applied bending force. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector comprises a unitary flexible having a plurality of weave patterns, laminations, or polymer cure formulations. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector has in-situ malleability that is adjustable after implantation. The present disclosure provides a stemless implantable device for joint arthroplasty in which the flexible connector has inherent adjustability that can correct misalignment caused by a non-parallel relationship of the proximal and distal anchors.The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector includes a malleable material between the anchor and the flexible connector. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector is malleable due to variable density, hardening, material properties, construction, geometry, manufacturing process, and / or other factors. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector includes a beam without bumpers; can provide stenting behavior to keep bone surfaces apart from one another, can have memory to return to a pre-flexed neutral flexion angle; and / or can have graduated or variable density with variable strength and flexibility attributes. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector is in a kit that includes a plurality of standard various angled implants to correct anchor misalignment. The present disclosure provides a stemless implantable device for joint arthroplasty, in which the flexible connector is in a kit that includes a plurality of flexible connectors having various pre-bent and neutral bend angles.

[0029] The present disclosure provides a system for attaching a rod to a flexible connector, the flexible connector including a hollow cylinder with an approximately 0.2 radian arc opening and generally parallel flanges protruding from an edge of the rod, the flanges configured to secure the flexible connector within a cross-sectional profile of the hollow cylinder.The present disclosure provides a system for attaching a flexible connector including a cannulated screw anchor with a longitudinal slot with an approximately 0.2 radian arc opening.

[0030] The present disclosure provides a surgical procedure for implanting a stemless implantable device for joint arthroplasty, the surgical procedure comprising the steps of: selecting a patient in need of implantation of a stemless implantable device for joint arthroplasty; providing a stemless implantable device for joint arthroplasty as disclosed herein; and implanting the stemless implantable device for joint arthroplasty into the patient. The present disclosure provides a surgical procedure for implanting a stemless implantable device for joint arthroplasty, the surgical procedure comprising the steps of: performing a minimally invasive lateral incision at an implant site of the patient; preparing a joint capsule and one or more phalanges at the implant site; press-fitting a lateral insert of the stemless implantable device for joint arthroplasty into the implant site or into a pre-fitted anchor system; and performing surgical closure of the wound at the implant site. The present disclosure provides a surgical procedure for implanting a stemless implantable device for joint arthroplasty, where preparing the joint capsule and phalanges includes resection of damaged cartilage and articular surfaces. The present disclosure provides a surgical procedure for implanting a stemless implantable device for joint arthroplasty, where the surgical procedure further includes capping the countersunk anchor holes using the resected bone.

[0031] According to yet another embodiment, the present disclosure provides uses and methods of devices as described herein, and at least one additional therapeutic agent or modality, for use in treating a disease or disorder in a patient, e.g., as described herein.

[0032] Embodiments of the present invention also provide a method for treating and / or preventing a disease or condition as described herein in a patient, said method comprising the steps of selecting a patient in need of treating and / or preventing said disease or condition as described herein; and administering a method and / or device of the present disclosure to the patient, thereby treating and / or preventing said disease in said patient.

[0033] Some embodiments of the present invention are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numbers may indicate similar elements and in which: [Brief description of the drawings]

[0034] [Figure 1] FIG. 1 is a diagram of a typical human hand skeleton with reference to standard medical nomenclature used to describe various anatomical elements. [Diagram 2] FIG. 1 is a perspective view of a human hand illustrating the standard nomenclature used to describe spatial relationships between elements. [Diagram 3] 1 is a side view of the interphalangeal bones of a human finger shown in a naturally flexed position superimposed in planar alignment with images of the same finger bones shown in extended and partially flexed positions, illustrating the arc of motion of a second phalange relative to a first phalange, the flexed position being depicted with a solid line and the extended position being depicted with a dashed or dotted line, the solid line tracing the arc of motion about an axis of rotation located within the first phalange. [Figure 4] FIG. 1 is a perspective view of a hand with the index finger in an extended position opposed by an axial force imposed by the thumb of the same hand, illustrating one type of accessory force resisted by the interphalangeal joint in normal use, referred to as a "key pinch." [Diagram 5]FIG. 1 is an illustration of a conceptual embodiment of a device as disclosed herein showing a first fixation rod, a mesh hinge, and a second fixation rod. [Figure 6] FIG. 1 is a perspective view of an exemplary embodiment of the overall device showing a proximal cannulated wide flange threaded anchor with radial slots and a reverse-threaded anchor cap, and a parallel distal connector of similar dimensions and configuration mirror-aligned about the mid-axis of one embodiment of a flexible connector with dorsal and palmar bumpers and continuous fixation bosses at the proximal and distal edges of said flexible connector that are inserted into the proximal and distal anchors, respectively, and secured therein by one embodiment of an anchor cap that screws into the heads of the respective anchors. [Figure 7] FIG. 1 is a cross-sectional view of an exemplary embodiment of an overall device as disclosed herein in an extended (unflexed) position showing the dorsal and palmar bumper flanges, the thickened configured barrel at the proximal and distal edges, and the keyhole slot at the proximal condylar head. [Figure 8] FIG. 1 is a plan view of an exemplary embodiment of a general device as disclosed herein in an extended position as viewed from the dorsal side. [Figure 9] FIG. 1 is an exploded perspective view of an exemplary embodiment of an overall device as disclosed herein in an extended position. [Figure 10] FIG. 1 is a side view of one embodiment of a general device as disclosed herein within the anatomy in an extended position. [Figure 11] FIG. 1 is a side view of an exemplary embodiment of a general device as disclosed herein in the anatomical structure in a flexed position. [Figure 12] FIG. 1 is a perspective view of an exemplary embodiment of a general device as disclosed herein, within the anatomical structure, in a partially flexed position. [Figure 13] FIG. 1 is a cross-sectional view of one embodiment of an overall device as disclosed herein in an anatomical structure in an extended position. [Figure 14] FIG. 1 is a perspective view of an exemplary embodiment of an overall device as disclosed herein utilizing a magnetized component in a proximal transverse anchor in an approximately parallel relationship with a magnetized component in a distal transverse anchor possessing the same magnetic polarity, to exert a stenting force between the proximal and distal magnetized components. [Figure 15] FIG. 1 is a perspective view of an exemplary embodiment of an overall device as disclosed herein utilizing a magnetized component in a proximal transverse anchor in a roughly parallel relationship with a magnetized component in a distal transverse anchor possessing an attracting magnetic polarity to exert a stabilizing force between the proximal and distal magnetized components. [Figure 16] FIG. 1 is a perspective view of one embodiment of a fixation anchor showing the engagement barbs. [Figure 17] FIG. 1 is a side view of an exemplary embodiment of a cannulated threaded anchor. [Figure 18] FIG. 13 is a head end view of a cannulated threaded anchor. [Figure 19] FIG. 1 is a perspective view of one embodiment of a threaded screw cap. [Figure 20] 1 is an exploded perspective view depicting an exemplary embodiment of a magnetic cap system configured to apply a stenting force while containing a connector within the anchor. [Figure 21] 1A is an exploded perspective view illustrating an exemplary embodiment of the overall device as disclosed herein, showing the cannulated anchor before and after insertion of a connector, and FIG. 1B is an exploded perspective view illustrating an exemplary embodiment of a reverse-threaded screw cap that is attached to the head of the cannulated anchor after insertion of a connector. [Figure 22] FIG. 1 shows a cross-section of one embodiment of a flexible connector comprised of a hydrophilic coating, showing an expansion zone of the coating, and further showing guide dots, which expand into a prepared hole in a cannulated anchor or bone. [Diagram 23] FIG. 1 depicts a longitudinal section through one embodiment of a mesh hinge illustrating an integrated rod pocket (or sleeve) woven into the connector to receive proximal and distal rods that are inserted into the respective proximal and distal rod sleeves. [Figure 24] FIG. 1 is a cross-sectional view of one embodiment of an overall device as disclosed herein in an anatomical structure in an extended position. [Diagram 25] FIG. 1 is a cross-sectional view of one embodiment of the overall device as disclosed herein, showing a 3D woven fabric with a diamond-shaped weft fiber profile and a foldable cage warp structure, resulting in the fabric lengthening along the sagittal axis when bent and preserving the coronal stability imparted by the 3D warp structure. [Figure 26] FIG. 1 is a perspective view of one embodiment of a connector fabric showing a core element constructed from multiple thin flat longitudinal strips of titanium or similar biocompatible material evenly spaced across the width of the connector and woven together with carbon nanofiber or carbon nanofiber braid or similar fatigue resistant flexible material in a weave pattern including variable cross-sectional profiles for the warp and weft fibers to customize stiffness and stability. [Figure 27] FIG. 1 illustrates a cross-sectional view of one embodiment of a flexible connector with a hollow bumper. [Figure 28]FIG. 1 is a flow diagram of the detailed components of the bone preparation aspect of the surgical procedure: (A) minimally invasive surgical access via a medial lateral incision; (B) guidewire insertion into the phalangeal bone; (C) external fixture alignment over the guidewire; (D) cannulated drill bit drilling into the phalangeal bone along the guidewire; (E) sagittal saw used to remove the bone wedge; (F) sagittal saw used to remove the bone wedge. [Figure 29] FIG. 1 depicts guidewire insertion into the phalanges. [Diagram 30] FIG. 1 depicts a cannulated drill bit drilling along a guidewire into a phalangeal bone. [Diagram 31] FIG. 13 depicts the external alignment fixture next to the phalanges. [Diagram 32] (A) is a perspective view of a smooth fixation rod with rotatable end caps, and (B) is a perspective view of a smooth fixation rod with cufflink style end caps. [Diagram 33] (A) A perspective view of a smooth fixation rod with fluting and (B) a perspective view of a smooth fixation rod with a surface treated to allow osseointegration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] An amount, as used herein, is "effective" when the amount provides an effect in a subject. As used herein, the term "effective" refers to an amount of a compound or composition, or an amount of a device and method, that is sufficient to induce a significant positive benefit, including the benefits disclosed herein, either alone or in combination, but sufficient to avoid significant side effects (i.e., sufficient to provide a reasonable benefit-to-risk ratio within the scope of the sound judgment of a person skilled in the art). For a person skilled in the art, an effective therapy (e.g., a compound or composition, or a device and method, and dosage and frequency of administration, etc.) can be determined according to their knowledge and standard methodology of mere routine experimentation based on the present disclosure.

[0036] As used herein, the terms "subject" and "patient" are used interchangeably. As used herein, the term "patient" refers to an animal, preferably a mammal, such as, for example, non-primates (e.g., cows, pigs, horses, cats, dogs, rats, etc.) and primates (e.g., monkeys and humans), and most preferably a human. In some embodiments, the subject is a non-human animal, such as a farm animal (e.g., horse, pig, or cow) or a pet (e.g., dog or cat). In certain embodiments, the subject is an elderly human. In another embodiment, the subject is a human adult. In another embodiment, the subject is a human child. In yet another embodiment, the subject is a human infant.

[0037] As used herein, in the context of administration of a therapy to a subject, the terms "prevent," "preventing," and "prevention" refer to preventing or inhibiting the recurrence, onset, and / or progression of a disease or condition, or combination of therapies (e.g., a prophylactic or therapeutic method, device, or combination of agents).

[0038] As used herein, the terms "therapies" and "therapy" can refer to any method, device, composition, and / or agent that can be used in the prevention, treatment, and / or management of a disease or condition, or one or more symptoms thereof.

[0039] As used herein, in the context of administration of a therapy to a subject, the terms "treat," "treatment," and "treating" refer to the reduction or inhibition of the progression and / or duration of a disease or condition, the reduction or amelioration of the severity of a disease or condition, and / or the amelioration of one or more symptoms thereof resulting from the administration of one or more therapies.

[0040] As used herein, the term "about," when used in conjunction with a recited numerical value or range, has the meaning that it would reasonably have by one of ordinary skill in the art, i.e., indicating something more or something less than the recited value or range.

[0041] Stemless Implantable Devices In general, the embodiments of the stemless implantable device of the present disclosure include a flexible connector that spans the joint space between, for example, the first and second phalanges in the coronal plane and bends in the sagittal plane to serve as a joint replacement system. The devices and methods of the present disclosure are also suitable for treating synovial joints such as the hand, wrist, elbow, shoulder, ankle, foot, jaw, and spinal subjoints, among others, and may be suitable for use in the large joints of the hip and knee in some cases. In the case of traumatic injuries, the devices and methods can be used to provide a joint in place of a damaged or severed joint. In certain embodiments, the flexible connector is secured along its proximal edge by a fixation system that is implanted transversely through the first phalange in the coronal plane, and secured along its distal edge by a similar fixation system that is implanted transversely through the second phalange in a parallel relationship to the first fixation system. In an exemplary embodiment, the overall dimensions of the joint replacement system can be confined within an envelope bounded by the superficial cortical surface of the bone of the original joint or of a similar joint in the patient or a subject of similar size to the patient. In certain embodiments of the present disclosure, custom implants can be designed for different patient profiles (e.g., athletes, musicians, or workers). These can have differential material strengths for different performance specifications.

[0042] In certain embodiments disclosed herein, the stemless implantable device and its components of the present disclosure can be made from a biocompatible material. A biocompatible material should be understood as a material that has a low level of immune response. A biocompatible material may also be referred to as a biomaterial. The same is a biocompatible metal, a metal that has a low immune response (e.g., titanium or tantalum, etc.). A biocompatible metal can also be a biocompatible alloy that includes at least one biocompatible metal. In certain embodiments, the biocompatible material can be formed, for example, from any suitable medical grade material, such as a biocompatible metal (e.g., stainless steel, titanium, titanium alloy, etc.) or a medical grade plastic (e.g., polyetheretherketone (PEEK), etc.), or a ceramic, or another radiolucent material, such as ultra-high molecular weight polyethylene (UHMWPE). In certain embodiments, the biocompatible material can be, for example, stainless steel, titanium, titanium alloys, medical grade plastics, silicone, polyetheretherketone (PEEK), ceramics, ultra-high molecular weight polyethylene (UHMWPE), carbon nanofibers, carbon strips, carbon plates, and combinations thereof. If desired, the implant can also be formed from a bioabsorbable material. The bioabsorbable material can be osteoconductive or osteoinductive (or both).

[0043] The implantable medical device according to any of the embodiments disclosed herein (including any components thereof) can include at least one material selected from the group consisting of polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA), and fluorinated ethylene propylene (FEP). Moreover, it is also contemplated that the material includes a metal alloy (e.g., cobalt-chromium-molybdenum, titanium, or stainless steel, etc.) or polyethylene (e.g., cross-linked polyethylene or gas sterilized polyethylene, etc.). The use of ceramic materials is also contemplated (e.g., zirconium ceramic or alumina ceramic, etc.) on the contact surface or throughout the medical device. The part of the medical device that is in contact with the human bone for fixation of the medical device to the human bone can include a porous structure, which can be a porous microstructure or nanostructure adapted to promote the growth of human bone in the medical device for fixation of the medical device. The porous structure can be achieved by applying a hydroxy-apatite (HA) coating, which can be produced by air plasma spraying, or a coarse open-pore titanium coating, and a combination including a coarse open-pore titanium coating and a HA top layer is also conceivable. The contact parts can be made of self-lubricating materials such as waxy polymers (e.g., PTFE, PFA, FEP, PE and UHMWPE, etc.), or made of powder metallurgy materials that can be infused with lubricants, which are preferably biocompatible lubricants (e.g., hyaluronic acid derivatives, etc.). In certain embodiments disclosed herein, the materials of the contact parts or surfaces of the implantable medical devices herein are adapted to be constantly or intermittently lubricated.According to some embodiments, parts or portions of the medical device may include combinations of metallic materials and / or carbon fiber and / or boron, combinations of metal and plastic materials, combinations of metal and carbon based materials, combinations of carbon and plastic based materials, combinations of flexible and rigid materials, combinations of elastic and less elastic materials, Corian or acrylic polymers.

[0044] According to some embodiments, the parts or portions of the medical device can include magnetic constructions. There are normal forces on the bearing surfaces of the joint. Reducing these normal forces can reduce the load of the joint, and thus reduce the wear of the joint. It is proposed herein that, for example, opposing magnets placed in or on the joint can be used to reduce these normal forces. It is preferable that this magnetic opposition occurs while the joint is in flexion or extension, since it is desirable for this force reduction to occur. Magnets attracting each other can also be used to increase implant stability.

[0045] The following options include both means to preserve and / or replace the bearing surface of the joint. In certain embodiments as disclosed herein, all or part of the components that are anchored to the bone are typically metallic and can include and / or be constructed from or include magnetic materials. For example, a rare earth magnet can be used with both components having similar polarity (e.g., negative polarity) facing each other. If it is desired to preserve the bearing surface of the joint while not loading the joint, a mechanism such as that shown in FIG. 14 can be utilized.

[0046] The opposing magnets in the joint can be straight or curved (e.g., as an opposing pair) depending on the clinical requirements. The opposing magnets are intended to provide normal force reduction, but the geometric relationship can be selected to include a lateral force vector to help stabilize the joint. It is possible that these effects can be controlled externally by application of an external magnetic field, or can be an inherent property of the material.

[0047] It is understood that lateral forces can be used to stabilize the joint. These forces, by their orientation, can help align the extension and flexion paths of the joint. Devices as disclosed herein can be adjusted relative to each other for proper tracking. They can be angled left or right from the natural axis of relative bending of the joint. In certain clinical situations, it may be desirable to change this relative angle. The gentle magnetic bias imposed by these off-axis magnets can result in a reorientation of the relative bending angle. In another embodiment, the alignment path can be adjusted by the insertion of a fixed alignment correction connector, which is fabricated with non-parallel fixed edges and is selected by the surgeon to correct a particular deviation in the alignment of a previously implanted transverse anchor.

[0048] In other clinical situations, it may be desirable to adjust the radial-ulnar (medial-lateral) angle of a joint. The use of magnets on one or both sides of the joint results in a biasing force that can result in realignment of the left and right tracking of the joint, for example, to stabilize the joint in situations where ligaments are not optimal.

[0049] According to some embodiments, parts or portions of a medical device can include biometric monitoring capabilities. Biometric monitoring as disclosed herein can include a sensor system that can be embedded in a thin, adhesive, compliant material that is applied to specific areas of interest. Exemplary areas include fingers, hips, and knees. These sensors map the anatomical area. If a threshold parameter is exceeded, the sensor will signal, for example, a telemetry receiver, which will activate an alarm to a nurse or other health care professional.

[0050] Embedded sensors are needed to detect certain internal parameters that cannot be directly seen by the human eye. These sensors can be used at specific locations to detect the specific parameters.

[0051] One way of implanting biometric monitoring sensors is through an open surgical procedure. During such a surgical procedure, the sensor is directly implanted into the bone or soft tissue by the surgeon or directly attached to an anchored implant (e.g., arthroplasty in a finger or knee). The sensor system can be used during the surgical procedure to inform the surgeon of the position and / or function of the implant, as well as soft tissue balance and / or alignment. The sensor is directly implanted by a penetrating instrument that releases the sensor at a pre-determined depth. The sensor can be attached to the anchored implant by a specific locking system or adhesive. The sensor is activated before closure to confirm the validity of the sensor.

[0052] The parameters and time factors to be evaluated will determine the energy source required for the implanted sensor. Short time frames (up to 5 years) allow for the use of batteries. Longer duration needs suggest the use of an external activation or powering system, or the use of the patient's kinetic energy to power the sensor system. These activation systems are currently available. The sensor can also be activated at pre-determined times to monitor implant cycles, abnormal movements, and implant wear thresholds.

[0053] In an exemplary embodiment, the information can be received telemetrically. In one exemplary embodiment, the sensor is pre-programmed to "activate" and send the necessary information if a certain threshold is exceeded. The sensor can also be activated and used to relay information to an external receiver. Further applications allow for the readjustment of "smart implants" to release specific medicines, biologics, or other substances, or to readjust the alignment or modularity of the implant.

[0054] The biometric sensor system can be initially activated and read at the clinic, further activation can occur in the patient's home, and the patient has the ability to send information (e.g., to a doctor) through an internet application. Software can be programmed to receive the information, process it, and then relay it to a healthcare provider.

[0055] A biometric monitoring sensor system as disclosed herein can be used to assess the function of internal implants. Current knowledge of actual implant function is poor. Physicians continue to use external methods (including x-rays, bone scans, and patient evaluations). However, they are typically left with only invasive surgical examinations for actual investigation of function. Using a biometric monitoring sensor system as disclosed herein allows for the detection of early malfunction and impending catastrophic failure of the implant. As such, early intervention is possible. This, in turn, reduces patient morbidity, reduces future medical costs, and improves the patient's quality of life.

[0056] Biometric monitoring sensor systems as disclosed herein are capable of monitoring important parameters of the implant-host system. Exemplary parameters that can be measured include implant stability, implant kinematics, implant wear, implant cycle time, implant identification, implant pressure / load, implant integration, joint fluid analysis, joint surface information, ligament function, and many others.

[0057] Application of the biometric monitoring sensor system as disclosed herein allows for determining whether the implant is unstable and / or whether excessive motion or subsidence occurs. In an exemplary application, the sensor can be configured to release active agents from activated implanted modules to increase integration. Alternatively and / or additionally, the implant biometric monitoring sensor system as disclosed herein can be used to adjust the angle / offset / soft tissue tension to stabilize the implant, if needed.

[0058] A joint implant biometric monitoring sensor system as disclosed herein can detect increases in heat, acid, or other physical properties. Such knowledge would provide early infection warning to the physician. In an exemplary infection treatment application, the sensor could activate an implanted module that releases, for example, an antibiotic.

[0059] Fastening system As described above, certain embodiments of the stemless implantable device of the present disclosure include a flexible connector that spans the joint space between the proximal and middle phalanges in the coronal plane, for example, and bends in the sagittal plane to serve as a joint replacement system. In certain embodiments, the flexible connector is secured along its proximal edge by a fixation system that is implanted transversely through the first phalange in the coronal plane, for example, and along its distal edge by a fixation system that is implanted transversely through the second phalange in a parallel relationship to the first fixation system. In certain embodiments disclosed herein, the fixation system is a transverse fixation system. In certain embodiments disclosed herein, the fixation system that is implanted transversely through the first phalange in the coronal plane and the fixation system that is implanted along its distal edge by the fixation system that is implanted transversely through the second phalange are similar. In other embodiments as disclosed herein, the fixation system implanted transversely through the first phalange in the coronal plane and along its distal edge with the fixation system implanted transversely through the second phalange are dissimilar.

[0060] In certain embodiments, the fixation system (such as, for example, a transverse fixation system) is made from a biocompatible material with suitable high fatigue strength and elastic modulus, e.g., similar to bone, and a surface chemistry that promotes histologically stable conditions at the implant-tissue interface (see FIG. 32, which shows a perspective diagram of a smooth anchor rod with rotatable end caps).

[0061] In certain embodiments, the fixation system (such as, for example, a transverse fixation system) is made from materials such as, but not limited to, titanium, titanium alloys, composites, nickel-free superelastic metal alloys, UHMWPE, hydroxyapatite (HA) coatings, bioactive materials, and composites that promote bone regeneration. (See FIG. 32 for a perspective view of the cufflink head showing the cufflink head in an operative state.)

[0062] In certain embodiments, the proximal edge of the flexible connector described above can be attached into a first bone and the distal edge of the proximal anchor can be attached into a second bone using any fixation method or combination of fixation methods and features, such as cemented, uncemented, osseointegrated, press fit, screw threads, capped, or other locking systems.

[0063] In certain embodiments, the fixation system (such as, for example, a transverse fixation system) can include surface patterning to enhance natural bone ingrowth into the anchors (see diagram in FIG. 33 for an example of surface patterning; see also U.S. Pat. No. 10,610,347; U.S. Patent Application Publication No. 2020 / 0149145; U.S. Patent Application Publication No. 2019 / 0231511).

[0064] In certain embodiments, a fixation system (such as a transverse fixation system) can include numerous individual "shark tooth" barbs in sufficient quantity and placement to impart stability within the patient's cancellous bone. The barbs can be configured and manufactured to break away under specific controlled mechanical action to allow expansion of the anchor (see FIG. 16).

[0065] In certain embodiments, a fixation system (such as, for example, a transverse fixation system) can include concentric fluting that is pitched in the direction of insertion to prevent dislocation in the direction of extraction.

[0066] Instead of a rigid pin or rod, a fixation system for a connector (such as a flexible connector as disclosed herein) can utilize a thickened barrel shape at the proximal and distal edges of the connector to be secured within the hollow shaft of a cannulated anchor that incorporates a slot wide enough to allow the connector to pass through the slot and into the joint cavity (see FIG. 13).

[0067] A fixation system for a connector (such as a flexible connector as disclosed herein), in certain embodiments, has a maximum length that does not exceed the intracortical dimension measured in the coronal aspect of the patient's bone at the site of implantation.

[0068] Fixation systems for connectors (such as, for example, flexible connectors as disclosed herein) in certain embodiments have a maximum dimension measured in the sagittal plane that is no more than approximately 70% of the bone dimension measured in the sagittal plane at the site of implantation after, for example, sectioning or debridement, to allow sufficient remaining bone to prevent bone fracture under normal force loading (see FIG. 28).

[0069] The fixation system may further include a rigid rod or pin that may be inserted into the pocket or sleeve to provide stability to the edge and facilitate insertion into the prepared bone (see FIG. 28).

[0070] In some embodiments, the rigid rod or pin can be barbed to ensure continuous engagement of the mesh along the entire length of the rod or pin and to prevent dislocation of the mesh connector during insertion of the implant device.

[0071] In other embodiments, instead of an integrally woven sleeve and barbed rods or pins, a smooth hollow cylinder with crimping flanges can be secured along the proximal and distal edges of the mesh connector. Barbs on the inner surface of the crimping flanges can be used to further secure the connector edges within the hollow cylinder when the crimping flanges are pinched together by a continuous brake (see FIG. 22).

[0072] anchor As described above, in certain embodiments, the stemless implantable device of the present disclosure includes a flexible connector that spans the joint space between, for example, a first phalange and a second phalange in the coronal plane and bends in the sagittal plane to serve as a joint replacement system. In certain embodiments, the flexible connector is anchored along its proximal edge by a fixation system that is implanted transversely through the first phalange in the coronal plane and anchored along its distal edge by a fixation system that is implanted transversely through the second phalange in a parallel relationship to the first fixation system. In certain embodiments disclosed herein, the fixation system is a transverse fixation system. In certain embodiments disclosed herein, the fixation system for the connector (such as, for example, a flexible connector as disclosed herein) is attached to the bone using an anchor. In certain embodiments, the anchor is a cannulated anchor. In certain embodiments, the cannulated anchor can be in the configuration of a wide flange screw to maximize the contact surface area with the bone into which it is inserted. The cannulated anchors can be manufactured from materials such as titanium or other biocompatible materials as disclosed herein and can optionally have a crystalline surface treatment to promote osseointegration of the anchors, for example, in cancellous bone.

[0073] In certain embodiments disclosed herein, the anchor is a device that is in direct contact with the bone. In certain embodiments disclosed herein, the flexible connector is located within the anchor. In certain embodiments disclosed herein, there is a cap / rivet that is part of the anchor device but is not itself the anchor body.

[0074] In certain embodiments, the proximal fixation system and / or the distal fixation system are attached to bone using cannulated anchors, the cannulated anchors having a varying, non-uniform pitch and / or a varying, non-uniform diameter.

[0075] In certain embodiments, the anchor is a cap that is mechanically fastened to the cortical bone to prevent lateral migration.

[0076] In certain embodiments, the anchor is an osseointegrated cortical bone cap, in which the patient's bone material harvested during surgical preparation is fitted into a cortical divot flush with the cortical bone surface above the rod heads after insertion of flexible connectors into both anchor rods.

[0077] In certain embodiments, the anchor is a temporary fixation of the cortical bone cap using a biodegradable material dimensionally larger than the cortical bone cap that is mechanically fastened to adjacent stable cortical bone to anchor the cortical bone cap until osseointegration is achieved.

[0078] In certain embodiments, the anchor is a wide flange cap that is screwed or locked into the head of the anchor rod and mechanically fastened to the cortical bone using a screw.

[0079] In certain embodiments, the anchors are flexible connectors that are pressed directly into the bone without fastening an anchor rod or pin, or with an expanding hydrogel composite (see FIG. 13).

[0080] In certain embodiments, the anchor comprises a magnetic construct, as described herein.

[0081] In certain embodiments, the anchors have biometric monitoring capabilities, as described herein.

[0082] In certain embodiments, the anchor has bone scaffold integration.

[0083] In a preferred embodiment, the anchor has a flute alignment that allows for approximately 110 degrees of rotation (see FIG. 33). In certain embodiments disclosed herein, the anchor has a wide thread with a fine pitch. In certain embodiments disclosed herein, the anchor is a cannulated screw with a longitudinal slot. In certain embodiments disclosed herein, the anchor has barbs that are configured and manufactured to break away under certain controlled mechanical action (see FIG. 9).

[0084] In certain embodiments disclosed herein, the anchor comprises an endo button-cuff link (see FIG. 32).

[0085] In certain embodiments disclosed herein, the anchor is a headless or headed screw.

[0086] In certain embodiments disclosed herein, the anchor is a smooth rod with a rivet cap (the cap is locked into the bone) (see FIG. 32). In certain embodiments disclosed herein, the anchor is an allograft bone scaffold. In certain embodiments disclosed herein, the anchor is a cannulated bone screw (see FIG. 9). In certain embodiments disclosed herein, the anchor has magnetic stenting via charging heads on both magnetic end caps (see FIG. 20). In certain embodiments disclosed herein, the anchor has in situ slots and / or has pre-fabricated slots.

[0087] connector As described above, in certain embodiments, the stemless implantable device of the present disclosure includes a flexible connector that spans the joint space between the proximal and middle phalanges in the coronal plane, for example, and flexes in the sagittal plane to serve as a joint replacement system. In certain embodiments, the connector can be, for example, a flexible connector, which in various embodiments can be manufactured using various fatigue-resistant biocompatible materials as disclosed herein, for example, silicone, ultra-high molecular weight polyethylene (UHMWPE), Nitinol shape memory alloy, titanium, and carbon nanofiber, strips or plates of various thicknesses and widths, as well as braided nanofiber elements woven in two- and three-dimensional arrays engineered to impart strength and flexibility as specified to meet the needs of the particular patient involved. The flexible connector can be designed to incorporate a range of strength, flexibility, elasticity, and other material properties to optimize the path of phalangeal motion and device durability.

[0088] In certain embodiments of the flexible connector, the pre-bent connector has differential bumper sizes and ratios to silicone. In certain embodiments of the flexible connector, for example, the silicone is custom printed with a mesh-like pattern to respond to stress in a unique manner.

[0089] In certain embodiments of the flexible connector, the in situ malleability can be adjusted after implantation. In certain embodiments of the flexible connector, there can be an inherent adjustability to correct misalignment caused by a non-parallel relationship of the proximal and distal anchors.

[0090] In certain embodiments of the flexible connector, there can be a malleable material between the anchor and the flexible connector.

[0091] In certain embodiments of the flexible connector, malleability results from the flexible connector due to variable density, hardening, material properties, construction, geometry, manufacturing process, and / or other factors.

[0092] In certain embodiments of the flexible connector, the flexible connector can be comprised of a beam without bumpers; can provide a stenting behavior to keep the bone surfaces apart from one another, can have memory to return to a pre-flexed neutral bend angle; and / or can have a graduated or variable density with variable properties of strength and flexibility.

[0093] In certain embodiments of the flexible connector, the kit comes with a variety of standard angled implants to correct anchor misalignment. In certain embodiments of the flexible connector, the kit comes with a variety of pre-bent and neutral bend angles.

[0094] In certain embodiments disclosed herein, the material properties of the flexible connector allow for smooth bending within the normal range of zero degrees to one hundred and ten degrees (0-110 degrees) when activated by the patient's flexor tendon system.

[0095] In certain embodiments disclosed herein, the flexible planar component is fabricated using one or more of a variety of fatigue-resistant biocompatible materials that are configured to allow joint motion in the sagittal plane when activated by the patient's flexor tendon system and to allow constrained accessory motion when subjected to external forces, such as when used to assist in grasping oddly shaped objects. In certain embodiments disclosed herein, the width does not exceed the intracortical dimension measured in the coronal plane of the patient's bone at the site of implantation. In certain embodiments disclosed herein, the path of motion in the sagittal plane can follow an arc path described, for example, by a normal interphalangeal joint or an approximation thereof (see FIG. 3). In certain embodiments disclosed herein, motion in the coronal plane is limited to an allowable motion between about 0 degrees and about 2 degrees. In a preferred embodiment, motion in the coronal plane is limited to an allowable motion of about 0 degrees.

[0096] In one embodiment, the flexible connector can be constructed from woven or laminated components to create a flexible mesh with various dynamic qualities and fixation methods. The "mesh connector" can be secured to the bones of the first and second phalanges using, for example, a fixation system consisting of rod pockets or sleeves that are integrally woven into the proximal and distal edges of the mesh connector.

[0097] In certain embodiments of the flexible connector, the stiffness can be specified to meet the needs of the particular patient involved. For example, in the absence of a healthy extensor tendon system, the surgeon can specify a stiff "spring mesh" that will passively return to a straight position upon release by the patient's flexor tendon system without the participation required by the extensor tendons. In this embodiment, the mesh connector stiffness maintains proper joint spacing to prevent bone-to-bone contact of the articular surfaces of the first and second bones of the joint. As described above, bone-to-bone contact is a common cause of severe pain in the advanced stages of all forms of arthritis. Bone-to-bone contact leads to inefficient joint mechanics, which can impair the range of motion of the finger, accelerate the degenerative process, and ultimately lead to ankylosis or complete loss of motion in the joint.

[0098] Additionally, in certain embodiments of the flexible connector, to prevent harmful bone-to-bone contact, the flexible connector can incorporate transverse bumpers to protect the termination surfaces of opposing bones of the joint from contact with the opposing bones of the joint.

[0099] A stiffer "spring mesh" embodiment can be achieved using a plain weave rather than a bias weave and a wide cross-sectional profile for the warp components that run perpendicular to the fixation pins or rods in the implant device. The spring mesh configuration provides lateral stability and alignment in the coronal plane without relying on articular ligaments.

[0100] With an intact, healthy tendon system and intact cartilage over the articular surface of the condylar head, the surgeon can specify a more elastic mesh connector that stretches in flexion, replicating the natural gliding path of a healthy joint, and contracts when the finger is actively extended by the patient's extensor tendon system. "Stretch mesh" or "flexible mesh" embodiments can be achieved, for example, by using a weave pattern that changes length when tension is applied, such as a bias weave with wide flat sections (similar to the weave typically found in "finger traps"). Additionally, fiber diameters or cross-sectional profiles can be specified to deliver the appropriate Young's modulus of elasticity to the weave pattern, allowing a stretch capacity in flexion of approximately 25% of the unflexed mesh length. Alternatively, the specific behavior of the stretch mesh can be achieved through the use of engineered polymers, as described below.

[0101] In different embodiments, the flexible connector can be constructed of a polymer (e.g., silicone, etc.) to allow translation and expansion that approximates the natural physiological motion of the interphalangeal joint. In certain embodiments, the silicone is custom printed with one or more engineered patterns to respond to stress in a unique manner, or custom printed with graduated densities, with the highest density in or near the fixation system and lower densities where greater flexibility is desired to achieve the desired trajectory path of motion. The polymer connector can incorporate a bumper flange that is oriented in a perpendicular manner to the coronal surface of the polymer connector to prevent bone-to-bone contact. The bumper flange can be gel-filled to allow dynamic response under various tensile and compressive conditions.

[0102] In certain embodiments, the bumper flanges can include hollow or gel-filled portions to allow translation of the second bone relative to the first bone along the arc of the motion trajectory. (See FIG. 27, which shows a cross-sectional view of one embodiment of a flexible connector with an integral transverse bumper showing hollow continuous openings in the profile of the bumper's dorsal and volar flanges.) In certain embodiments, the geometry of the proximal and distal edges are configured as required for anchoring to a mechanical anchor or directly into bone, as described herein.

[0103] In the flexible connector embodiments described herein (including mesh connectors and polymer connectors, which represent some of the many possible materials and composite configurations that may be used within the spirit and scope of the present invention), flexing through the entire area of ​​the flexible connector distributes bending stresses evenly to minimize material fatigue. Multiple weave patterns, laminations, or polymer cure formulations can be used in unitary flexible connectors to allow for differential stiffness, flexibility, strength, and fatigue resistance designed to manage variable stress patterns through various sections of the connector.

[0104] In certain embodiments disclosed herein, the implant is sufficiently stiff to resist forces in the coronal plane, for example, to optimize gripping with thumb and finger. In certain embodiments disclosed herein, there may be some movement in the coronal plane, but this will result from, for example, the material properties of the flexible connector.

[0105] In certain embodiments disclosed herein, an implant isolation in the form of a pseudo-synovium can form around the flexible connector.

[0106] Anchor-connector fastening In certain embodiments disclosed herein, the proximal and / or distal fixation rods are independently barbed, e.g., for connection to an anchor. In certain embodiments disclosed herein, the proximal and / or distal fixation rods independently include anti-pullout pegs.

[0107] In certain embodiments disclosed herein, the proximal fixation rod and / or the distal fixation rod, independently, are non-rotating versions, for example with thinner flutes.

[0108] In certain embodiments disclosed herein, the proximal fixation rod and / or the distal fixation rod independently include an expanding hydrogel core for added stability during hardening.

[0109] In certain embodiments disclosed herein, the proximal and / or distal fixation rods are independently fluted radian variations optimized for rotation versus pull-out. See, for example, the radian slot opening labeled "θ" in FIG. 18. This radial dimension will vary depending on the flexible connector dimensions and connector anchor fixation type, the material properties of the flexible connector, and the location of the anchor at the proximal or distal location.

[0110] In certain embodiments disclosed herein, the fluting of the anchor is, for example, a wedge-shaped cutout in the anchor that allows the flexible connector to exit the anchor and allows some / amount of rotation of the connector during active movement. In certain embodiments disclosed herein, the flutes are designed to allow exit of the flexible connector and are designed as angled "pie-slice" instead of straight slots. This allows rotation of the connector during, for example, finger flexion. This "pie-slice" cutout can be optimized to be large enough to allow some rotation during flexion but not too large to allow easy disengagement of the connector from the anchor.

[0111] Implant-bone interface In certain embodiments disclosed herein, the proximal fixation system and / or the distal fixation system independently include an osseointegrated surface treatment. In certain embodiments disclosed herein, the proximal fixation system and the distal fixation system independently include barbs that are configured and manufactured to break away under certain controlled mechanical action (press fit with barbs with breakaway barbs). In certain embodiments disclosed herein, the proximal fixation system and the distal fixation system independently mechanically fasten metal to cortical bone.

[0112] In certain embodiments disclosed herein, the proximal and distal fixation systems independently use a reverse thread concept to increase pull-out strength or to simulate a "lock nut" style fastening or tightening.

[0113] In certain embodiments disclosed herein, the proximal and distal fixation systems independently include an anchoring bone rivet or screw cap (see FIG. 21). In certain embodiments disclosed herein, the proximal and distal fixation systems independently include a bone scaffold integration. In certain embodiments disclosed herein, the proximal and distal fixation systems independently include a magnetic construct.

[0114] In certain embodiments disclosed herein, the proximal and distal fixation systems independently include electronic monitoring capabilities. In certain embodiments disclosed herein, the proximal and / or distal fixation systems independently include biometric monitoring.

[0115] In certain embodiments disclosed herein, the proximal and distal fixation systems are inserted directly into the bone without anchors using pins or hydrogel cores, In certain embodiments disclosed herein, the flexible connector can include a bumper, and the flexible connector can be inserted directly into the bone.

[0116] Exemplary embodiments (figures) FIG. 1 shows an illustration of the bones of the hand, which is provided for reference to standard anatomical nomenclature referenced herein. The bones of the fingers, as numbered in the fourth finger (pinky finger) 110, include the metacarpal 102, proximal phalanges 104, middle phalanges (intermediate phalanges) 106, and distal phalanges 108. The bones of the thumb 112 include the metacarpal 102, proximal phalanges 104, and distal phalanges 108. There is no middle phalange in the thumb. The joint between the metacarpal and proximal phalanges is called the metacarpophalangeal joint or MCP joint 118. The joint between the proximal and middle phalanges is called the proximal interphalangeal joint, PIP, or PIPJ 120. The joint between the middle and distal phalanges is called the distal interphalangeal joint or DIP 122. Biological joints typically include a joint capsule 127 that surrounds a joint cavity 128. The joint capsule contains dense tissues such as connective tissue and collagen fibers and has a higher density than the outer tissues (except for bone and intra-articular ligaments). The joint cavity is significantly less dense than the joint capsule.

[0117] FIG. 2 shows the anatomical conventions of orientation through the hand. The front-to-back plane through the midline of the body is called the sagittal plane 201, which runs front-to-back through the hand, dorsal to palmar. A plane drawn across the hand is the transverse plane 202. A plane drawn through the side of the body or through the side of the hand perpendicular to the sagittal plane is called the coronal plane 203. The back side of the hand is called the dorsal aspect 204. The palm side of the hand is called the palmar or palmar aspect 208. The thumb side of the hand adjacent to the radius bone of the forearm is called the radial aspect 207. The pinky side of the hand adjacent to the ulna bone of the forearm is called the ulnar aspect 205.

[0118] 3 depicts a perspective view of the anatomical structures at the proximal interphalangeal joint shown in a flexed position. The bones of the finger include the proximal phalange 302, the middle phalange (intermediate phalange) 301, and the distal phalange 303. The middle phalange is shown in a partially flexed position 305 and an extended position 304.

[0119] FIG. 4 depicts a perspective view of a hand with the index finger in an extended position opposed by an axial force imposed by the thumb of the same hand, illustrating one type of accessory force resisted by the interphalangeal joint in normal use at a “key knob” 401.

[0120] FIG. 5 illustrates an illustration of a conceptual embodiment of the present invention showing a proximal fixation rod or pin 502, a leading end 504 of said fixation rod or pin 502, a proximal edge 506 of a mesh hinge 508, a leading lateral edge 510, a distal fixation rod 512, and a distal edge 514 of the mesh hinge 508.

[0121] FIG. 6 depicts a perspective view of a proximal cannulated wide flange threaded anchor 603 with radial slots and reverse threaded anchor cap 602 and a parallel distal connector of similar size and configuration mirror-aligned about the mid-axis of one embodiment of a flexible connector having dorsal and palmar bumpers 601 and continuous fixation bosses at the proximal and distal edges of said flexible connector which are inserted into the proximal and distal anchors, respectively, and secured therein by one embodiment of an anchor cap which screws into the head of each anchor 602.

[0122] 7 depicts a cross-sectional view of one embodiment of a flexible connector 704 in an extended (unflexed) position showing dorsal and palmar bumper flanges 705, 706, a thickened barrel at the proximal and distal edges 703, 707, and a keyhole slot 702 at the proximal condyle. In this embodiment, the proximal edge 703 is shown inserted into a proximal fixation rod 701 and the distal edge 707 is shown inserted 709 into a distal fixation rod 702, which may have surface patterning 708.

[0123] 8 illustrates a top view of an exemplary embodiment of an implant device as disclosed herein showing a polymer connector 804 with an end 802 inserted into a cannulated screw anchor 806. The cannulated screw anchor head 808, threads 807, cannula 805, cannula space 802, and end cap 808.

[0124] FIG. 9 shows an exploded perspective view of an implant device as disclosed herein, showing cannulated screw anchors 902, 903, cannulated screw anchor head 910, guide dot 911, flexible connector 901 in an extended (unbent) position, and end caps 904, 905 with threads 913.

[0125] 10 depicts a cross-sectional side view of an implant device as disclosed herein inserted into the proximal phalanges 1002 and distal phalanges 1001 in an extended position, depicting a polymer connector 1005 with dorsal bumper 1007 and palmar bumper 1008 with ends inserted into cannulated screw anchors 1003, 1004. A keyhole slot 1006 in the distal condyle is also depicted.

[0126] 11 depicts a perspective view of an implant device as disclosed herein inserted into the proximal phalanges 1101 and distal phalanges 1102 in a flexed position, depicting a polymer connector 1105 with dorsal bumper 1107 and palmar bumper 1108 with ends inserted into cannulated screw anchors 1103, 1104. A keyhole slot 1106 in the proximal condyle is also depicted.

[0127] 12 depicts a perspective view of an implant device as disclosed herein inserted into the proximal phalanges 1201 and distal phalanges 1202 in a flexed position, depicting a polymer connector 1207 with dorsal bumper 1205 and palmar bumper 1208 with ends inserted into cannulated screw anchors 1203, 1204. Also depicted is a keyhole slot 1204 in the proximal condyle.

[0128] 13 depicts a cross-sectional side view of an implant device as disclosed herein inserted into the proximal and distal phalanges in an extended position, depicting a polymer connector 1305 with dorsal bumper 1303 and palmar bumper 1304 with ends inserted directly into bone 1301, 1302. Also depicted is a keyhole slot 1306 in the distal condyle.

[0129] FIG. 14 illustrates a top view of an exemplary embodiment of an implant device as disclosed herein inserted into the proximal phalanges 1403 and distal phalanges 1405 in an extended position, illustrating the polymer connector 1404 and illustrating that the magnetized component 1401 in the proximal transverse anchor is in an approximately parallel relationship with the magnetized component in the distal transverse anchor 1402 possessing the same magnetic polarity, such that a stenting force is exerted between the proximal and distal magnetized components.

[0130] FIG. 15 illustrates a top view of an exemplary embodiment of an implant device as disclosed herein inserted into the proximal phalanges 1503 and distal phalanges 1505 in an extended position, illustrating the polymer connector 1504 and illustrating that the magnetized component 1501 in the proximal transverse anchor is in an approximately parallel relationship with the magnetized component 1502 in the distal transverse anchor possessing an attracting magnetic polarity, such that a stabilizing force is exerted between the proximal and distal magnetized components.

[0131] FIG. 16 illustrates a side view of one embodiment of a fixation rod 1601 showing multiple barbs 1602.

[0132] FIG. 17 illustrates a side view of the cannulated screw anchor, the head 1701 of the cannulated screw anchor, threads 1703, cannulated space 1704, and internal threads for attachment of end cap 1702.

[0133] FIG. 18 is a top cross-sectional view of a cannulated screw anchor 1801 with threads 1803, guide dots 1804, and an opening for a flexible connector 1802.

[0134] FIG. 19 is a perspective view of an end cap 1902 with threads 1901 .

[0135] 20 shows an exploded perspective view of an implant device as disclosed herein showing a cannulated screw anchor 2005, threads 2006, flexible connector 2007 in an extended (unflexed) position, and magnetic end caps 2001, 2002, 2003, 2004. In this exemplary embodiment, the transverse fixation system is inserted into the phalanges using a surgical method as described herein. In this exemplary embodiment, the transverse fixation system is made of a magnetic material and has magnetic end caps.

[0136] FIG. 21 shows a perspective view of a flexible connector 2103 being inserted into a cannulated screw anchor 2102 with an end cap 2101 .

[0137] FIG. 22 is a cross-sectional view of an anchor 2202 with guide dots 2204 and a flexible connector 2203 inserted into the anchor 2201.

[0138] FIG. 23 is a cross-sectional view of a flexible connector 2303 in an extended configuration illustrating integrated rod pockets 2304 (or sleeves) woven into the connector to receive proximal and distal rods 2302 inserted into the respective proximal and distal rod sleeves.

[0139] FIG. 24 is a cross-sectional view of a flexible connector 2402 with a solid insert 2401 in an extended position.

[0140] FIG. 25 is a cross-sectional view of a flexible connector 2502 in an extended position with a mesh insert 2501.

[0141] FIG. 26 is a perspective view of a flexible connector 2602 in an extended position with a mesh insert 2601.

[0142] FIG. 27 is a cross-sectional view of a flexible connector with a dorsal flange 2701 in hollow 2702 and a palmar flange 2703 in hollow 2704.

[0143] FIG. 28 is a perspective view of a surgical procedure for implantation of an implant device as disclosed herein, showing a guide wire 2802, an outer jig 2803, a hollow drill bit 2804, a hollowed out phalange 2805, and a transverse bone saw 2806.

[0144] FIG. 29 is a perspective view of a guidewire 2901 being inserted into a phalangeal joint 2902 .

[0145] FIG. 30 is a perspective view of a hollow drill bit 3002 that uses a guide wire 3001 to drill into a phalange 3003.

[0146] FIG. 31 is a perspective view of an external jig 3101 that guides the insertion of guidewires 3102, 3103 into the phalangeal joint.

[0147] FIG. 32 is a perspective view of a smooth fixation rod 3201 with rotatable end caps 3202, 3203 showing direction of movement 3204, and also a perspective view of a smooth fixation rod 3205 with cufflink style end caps 3206, 3207 showing direction of movement 3208.

[0148] Figure 33(A) is a perspective view of a fixation rod 3301 with fluting 3302. Figure 33(B) is a perspective view of a fixation rod 3303 with a surface that has been treated to allow osseointegration 3304.

[0149] surgical method The present disclosure provides a surgical method where, for example, surgical access and preparation of the implantation site is achieved through a single mid-lateral incision without disturbance to the tendon system. The transverse implantation method as disclosed herein allows for the use of minimally invasive surgical access via a mid-lateral incision. The mid-lateral approach avoids the need to interfere with the flexor and extensor tendon system during surgery and allows the joint to be trained immediately after removal of sutures without stressing the surgical wound.

[0150] The disclosed embodiments are surgically simple, without the risk of failure from bone loosening, and allow an approach to treatment that is not contraindicated in patients with osteoarthritis, inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, lupus, gout, pseudogout), or traumatic arthritis. Advantageously, the disclosed embodiments do not rely on ligaments for stability or extensor tendons for proper function. Thus, the disclosed embodiments can be used to reverse small joint unions and can be successfully revised without significant risk of bone failure leading down the path to amputation.

[0151] The incision is no longer necessary to expose the lateral aspect of the joint capsule and to release the angular deformity and flexion contracture. Following proper alignment, the bone is prepared to receive the implant device by drilling parallel holes and then sawing a continuous straight slot between the holes. The device is press-fit into the prepared bone opening and the wound is then closed. Once the sutures are removed, movement training under the care of the therapist begins at the first postoperative appointment.

[0152] The procedure is performed under sterile conditions in an operating room. Preparation begins with decontamination of the upper extremity with surgical preparation above the elbow. An upper extremity tourniquet or a finger tourniquet can be used to promote hemostasis during the procedure.

[0153] The patient is draped in a sterile fashion, leaving the operative limb exposed (use of a limb drape is recommended). The arm is elevated, exsanguinated, and a tourniquet is inflated to a pressure of 250 mmHg, or a finger tourniquet is applied. A lateral incision is made on either the radial or ulnar aspect of the knuckle, depending on the surgeon's preference. A drill is used to create parallel holes spanning the joint without penetrating the opposing cortical bone. A sagittal saw is used to create a thin channel connecting the parallel drilled holes. If necessary, a burr is used to resect portions of the condyle that show evidence of damaged cartilage or articular surface. The resected bone material (if present) is left for potential use in capping the anchor hole following insertion of the implant.

[0154] The implant is sized for width using a depth gauge, selected, and press-fit into the prepared bone space.

[0155] In another embodiment of the procedure using cannulated screw anchors, the anchors are sized and countersunk below the surface of the cortical bone. After insertion of the implants into the proximal and distal cannulated screw anchors, the countersunk anchors are capped with resected bone flush with the adjacent cortical surface. The wound is irrigated and the skin is closed with monofilament sutures. Once the sutures are removed, exercise training under the care of the therapist begins at the first postoperative visit.

[0156] FIG. 28 illustrates a flow diagram of the detailed components of the access and implant aspects of the surgical procedure.

[0157] Skin and soft tissue preparation includes the following steps: First, a #15 scalpel blade is used to incise the skin 2801. Blunt dissection is performed up to the transverse support ligament, which is divided. If more exposure is required, the lateral cords can be divided as well. The tendons are not damaged. Angular or contracture deformities can be corrected at this point by releasing taut soft tissue, including scarred or contracted collateral ligaments and / or volar plates. Sufficient soft tissue release is confirmed by demonstrating complete passive flexion and extension in the sagittal plane.

[0158] The bone is prepared by resecting portions of the condyle that show evidence of damaged cartilage or articular surfaces, with the resected bone material (if present) remaining for use in capping the anchor holes following insertion of the implant.

[0159] The width of the distal bone will determine the width of the implant selection and will set the depth of the rod holes and mesh channels. To begin the drilling procedure 2802, a marked guide wire is drilled transversely parallel to the head of the proximal bone (e.g., the proximal phalanx) and in line with the approximate axis of rotation. The far cortex should not be drilled. Intraoperative fluoroscopy can be used to confirm proper pin trajectory. A protruding pin is inserted into the guide hole. A parallel drill guide, set at a distance equal to the length of the implant device, is then placed over the first pin and used to drill a second pin transversely through the distal bone, a precise distance away from and parallel to the first pin. Care should be taken at this step to avoid perforating the far cortex.

[0160] The parallel guides are then removed. The shorter of the two guidewire measurements is selected as this will determine the drilling depth (e.g., 15 mm). A cannulated three millimeter (3 mm) marked drill bit can be used to drill onto each guidewire to a pre-determined depth. A sagittal saw with a one millimeter (1 mm) blade thickness is then used to cut a continuous straight channel between the center points of the two bores (2806). Again, care should be taken to avoid perforating the distant cortex.

[0161] Additional bone preparation involves cutting a keyhole-shaped opening that expands the sagittal channel only toward the palmar aspect of the first phalange.

[0162] In another embodiment of a procedure using a cannulated screw anchor, the anchor is sized and countersunk below the surface of the cortical bone.

[0163] The appropriate size implant device is selected based on the depth of the drilling or anchor device. The selected implant device can be press-fit into the prepared bone cavity or anchor device.

[0164] If cannulated screw anchors are used in place of fixation rods or pins, after insertion of the implants into the proximal and distal cannulated screw anchors, the countersunk anchors are preferably capped with the patient's own resected bone, and the resected bone cap is then trimmed flush with the adjacent cortical surfaces.

[0165] The wound is then irrigated and the skin closed with monofilament sutures.

[0166] Preferably, after the sutures are removed, exercise training under the care of a therapist begins at the first post-operative visit.

[0167] The present invention will be illustrated in more detail with reference to the following examples, but it should be understood that the invention is not to be considered as being limited thereto.

[0168] example Example 1 - Surgical method According to some embodiments and as described herein, surgical access and preparation of the implantation site can be accomplished through a single mid-lateral incision without disturbing the adjacent tendon system. The transverse implantation method as disclosed herein allows for the use of minimally invasive surgical access via a mid-lateral incision. The mid-lateral approach avoids the need to interfere with the flexor and extensor tendon system during surgery and allows the joint to be trained immediately upon removal of sutures without stressing the surgical wound. An exemplary surgical method is as follows:

[0169] 1) Under tourniquet control, a medial lateral incision is made on either the radial or ulnar aspect of the proximal interphalangeal joint. A #15 knife is used to incise the skin. Blunt dissection is performed down to the transverse ligament.

[0170] 2) The transverse ligament is sharply divided with a #15 knife. The collateral ligaments are sharply divided to expose the joint and allow the joint to be "booked open" with the intact collateral ligaments as hinges.

[0171] 3) The joint is then "opened" hinged on the intact collateral ligaments so that the joint can be examined. If the joint is arthritic or of poor quality for any other reason, the procedure can proceed. In the unlikely event that the joint is found to be of good quality, the soft tissue should be repaired and the procedure is stopped.

[0172] 4) Large osteophytes are removed with a rongeur to smooth the contours of the proximal and middle phalanges. The base of the middle phalange usually does not require further preparation. A sagittal saw (9mm x 15mm) is then used to remove the articular bearing condyle from the head of the proximal phalange. This cut should be made at the collateral ligament origin / metaphyseal flare of the proximal phalange. The cut should be relatively perpendicular to the bone in the coronal and sagittal planes, but a true orthogonal cut is not required.

[0173] 5) After removal of the condyle, a guidewire (GW) is placed into the head of the proximal phalanx along the axis of rotation. In certain embodiments, a pre-positioning alignment guide is used to ensure proper bone cut and offset for guide pin placement. Such a guide can rely on the universal commonality of the proximal phalanx. The guidewire should be advanced through the far cortex just far enough to puncture and exit the skin on the other side. A handheld pin guide / soft tissue protector is then placed over the proximal phalanx guidewire (GWp) and used to determine the exact location for placement of the second guidewire (GWm), which will be positioned at the base of the middle phalanx. With the assistance of multi-planar intraoperative fluoroscopy (mini C-arm), the GWm is placed into the middle phalanx and advanced through the far cortex just far enough to puncture and exit the skin on the other side. The handheld guide is removed and multiplanar fluoroscopy is used to confirm proper guidewire positioning. In a specific embodiment, an implant positioning tool is used to place the guide pins after they have been threaded through the far cortex of the proximal and middle phalanges. This device has similar kinematic characteristics to the flexible connector. It is attached to the pins and allows the surgeon to determine the path of motion before drilling over the guide pins. Once the path is confirmed to be correct (and free of malrotation / angulation), the surgeon will overdrill the guide pins with a cannulated drill.

[0174] 6) Once proper guidewire positioning is confirmed, a trial implant device is attached to the end of the guidewire exiting the skin. With the trial implant device in place, the finger position is assessed clinically at rest with a wrist tenodesis maneuver (flexing and extending the wrist). The finger is then assessed clinically while it is moved through an arc of passive flexion and extension. If there is any angulation, rotation, scissoring, or finger malalignment, the guidewire should be repositioned until these issues are resolved.

[0175] 7) When finger posture and function are well aligned and balanced, a cannulated drill (2.5 mm) is placed over the GWp and used to drill a receiving hole in the proximal phalanx. The drill is advanced through the near cortex, transversely across the head of the proximal phalanx, and stops at the far cortex. The far cortex is not perforated by the drill. A drill is then placed over the GWm and used to create a receiving hole in the middle phalanx. The drill is advanced through the near cortex and advanced to, but not through, the far cortex of the middle phalanx. The drill is removed, leaving the guidewire in place.

[0176] 8) A transverse anchor device (TAD) (TADp) to be inserted into the proximal phalanx as disclosed herein is then placed over the GWp and inserted into the receiving hole using a cannulated screwdriver. The TADp is advanced until the trailing head is recessed just below the proximal cortex. The TADp is turned with the screwdriver to align the guide mark (light dot) so that it is facing the middle phalanx. The cannulated channeled transverse anchor is unique. After placement of the anchor, the guide wire and positioning tool are removed.

[0177] 9) A transverse anchor device (TADd) to be inserted into the distal phalanx as disclosed herein is then placed over the GWm and inserted into the receiving hole using a cannulated screwdriver. The TADd is advanced until the trailing head is recessed just below the proximal cortex. The TADd should be turned with the screwdriver to align the guide mark (light dot) so that it is facing the guide mark of the proximal phalanx. Aligning the guide marks so that they face each other ensures alignment of the built-in cutting guide. The channel of the anchor also acts as a built-in cutting guide, allowing for removal of a precise amount of bone in a pre-determined "radian" configuration.

[0178] 10) The trial implant device is removed from the guide wire. The guide wire is then removed. A sagittal saw (or cutting jig) is then used to remove wedges of bone proximally and distally corresponding to the TADp and TADd built-in cutting guides.

[0179] 11) A formal implant is selected and opened from a separate sterile "peel pack". Preferably the implants provide different variations, for example: - Rigidity (Sports) - Flexibility (Art) - Length (for larger hands) - Design (textile fibers vs. silicone cushions vs. magnets)

[0180] 12) The implant rods are press-fit into the receiving ports of the TADp and TADd. The rods can be further secured by threaded screw caps.

[0181] 13) Next, the finger position and passive function are assessed. In certain embodiments, final adjustments can be made by heating the implant. Note that the amount of heat used during this step must be safe for the soft tissue. In some cases, the implant can be heated by a laser. This step allows any necessary or desired corrections to be made in the coronal and sagittal planes.

[0182] 14) The wound is then irrigated. The transverse ligament is closed with 5-0 Vicryl sutures. The skin is then closed with 4-0 chromic or nylon sutures depending on the surgeon's preference.

[0183] 15) The wound can then be bandaged with dry gauze and the hand placed into a palmar-based plaster splint at the end of the procedure.

[0184] 16) Preferably, range of exercise training under the care of a certified hand therapist should begin 7 to 10 days after surgery if the wound is deemed to be in favorable condition for such therapy.

[0185] 17) In certain embodiments, the system allows for post-insertion position correction. The flexible connector material can be modified over a period of time after insertion to allow for correction of any movement irregularities. This is based on the flexible connector material's ability to be configurable in certain circumstances.

[0186] Robotic Procedure Option As an alternative to the procedures outlined above, the device can be implanted using robotic instruments designed to replicate the steps and / or outcomes of the procedures.

[0187] Alignment Check Additionally, in certain embodiments, a temporary device can be used to check the alignment. The temporary device can be set at the tip of the guidewire (which is preferably 0.1 mm to 0.6 mm in diameter) over the guidewire protruding through the opposite cortex and skin. Alternatively, the guidewire can be realigned to sit in a new hole, or it can use the same hole as a starting point and be inserted so that it has a different trajectory. Using a guidewire with a smaller diameter or using a jig can allow additional attempts to check the alignment. Pre-alignment can be achieved by using a jig to test the path of motion. In some cases, a temporary provisional implant can be utilized to assess the path of motion before drilling.

[0188] conclusion Although the invention has been described in specific detail with reference to disclosed embodiments, it will be understood that many variations and modifications can be effected within the spirit and scope of the invention as set forth in the appended claims. [Explanation of symbols]

[0189] 102 Metacarpus 104 Proximal phalanx 106 Middle phalanx (middle phalanx) 108 Distal phalanx 110 4th finger (little finger) 112 Thumb 118 Metacarpophalangeal joint, MCP joint 120 Proximal Interphalangeal Joint, PIP, PIPJ 122 Distal Interphalangeal Joint, DIP 201 sagittal plane 202 Cross Section 203 Coronal 204 Dorsal aspect 205 Ulnar side 207 Radial side 208 Palmar side 301 Middle phalanx (middle phalanx) 302 Proximal phalanx 303 Distal phalanx 304 Extended position 305 Partially bent position 401 "Key knob" 502 Proximal fixation rod or pin 504 Leading edge 506 Proximal edge 508 Mesh Hinge 510 Leading lateral edge 512 Distal fixation rod 514 Distal edge 601 Dorsal and palmar bumpers 602 Anchor cap with reverse thread 603 Proximal Cannulated Wide Flange Threaded Anchor 701 Proximal Fixation Rod 702 Keyhole slot in the proximal condyle 703 Proximal edge 704 Flexible Connector 705 Rear bumper flange 706 Palm side bumper flange 707 Distal edge 708 Surface Patterning 709 Insertion 802 End, Cannula Space 804 Polymer Connector 805 Cannula 806 Cannulated screw anchor 807 Thread 808 Head, end cap 901 Flexible Connector 902 Cannulated screw anchor 903 Cannulated screw anchor 904 End Cap 905 End Cap 910 Head 911 Guide Dot 913 Thread 1001 Distal phalanx 1002 Proximal phalanx 1003 Cannulated screw anchor 1004 Cannulated screw anchor 1005 Polymer Connector 1006 Keyhole Slot 1007 Rear bumper 1008 Palm side bumper 1101 Proximal phalanx 1102 Distal phalanx 1103 Cannulated screw anchor 1104 Cannulated screw anchor 1105 Polymer Connector 1106 Keyhole Slot 1107 Rear bumper 1108 Palm side bumper 1201 Proximal phalanx 1202 Distal phalanx 1203 Cannulated screw anchor 1204 Cannulated screw anchor 1205 Rear bumper 1207 Polymer Connector 1208 Palm side bumper 1301 Bone 1302 Bone 1303 Rear bumper 1304 Palm side bumper 1305 Polymer Connector 1306 Keyhole Slot 1401 Components 1402 Distal Transverse Anchor 1403 Proximal phalanx 1404 Polymer Connector 1405 Distal phalanx 1501 Magnetized Components 1502 Magnetized Components 1503 Proximal phalanx 1504 Polymer Connector 1505 Distal phalanx 1601 Fixed rod 1602 Barb 1701 Head 1702 End cap 1703 Thread 1704 Cannula Space 1801 Cannulated screw anchor 1802 Flexible Connector 1803 Thread 1804 Guide Dot 1901 Thread 1902 End cap 2001 Magnetic End Caps 2002 Magnetic End Caps 2003 Magnetic End Caps 2004 Magnetic End Caps 2005 Cannulated screw anchor 2006 Thread 2007 Flexible Connector 2101 End cap 2102 Cannulated screw anchor 2103 Flexible Connector 2201 Anchor 2202 Anchor 2203 Flexible Connector 2204 Guide Dot 2302 Proximal rod, distal rod 2303 Flexible Connector 2304 Rod Pocket 2401 Solid insert 2402 Flexible Connector 2501 Mesh insert 2502 Flexible Connector 2601 Mesh insert 2602 Flexible Connector 2701 Back flange 2702 Hollow 2703 Palmar flange 2704 Hollow 2801 Skin 2802 Guidewire 2803 External fixture 2804 Hollow Drill Bit 2805 Hollowed out phalanges 2806 Transverse Bone Saw 2901 Guidewire 2902 Interphalangeal joints 3001 Guidewire 3002 Drill Bit 3003 Phalanges 3101 External fixture 3102 Guidewire 3103 Guidewire 3201 Smooth Fixed Rod 3202 Rotatable End Cap 3203 Rotatable End Cap 3204 Direction of movement 3205 Smooth Fixation Rod 3206 Cufflink Style End Caps 3207 Cufflink Style End Caps 3208 Direction of movement 3301 Fixed rod 3302 Fluting 3303 Fixed rod 3304 Osseointegration

Claims

1. 1. A stemless implantable device for joint arthroplasty, the device comprising: - includes a flexible connector; - optionally including a proximal transverse fixation system; - optionally including a distal transverse fixation system; Optionally, the flexible connector is attached at one end to the proximal transverse fixation system and at the other end to the distal transverse fixation system.

2. The device of claim 1 , wherein the proximal transverse fixation system includes a smooth or barbed rod.

3. The device of claim 1 or 2, wherein the distal transverse fixation system includes a smooth or barbed rod.

4. The device according to claim 1 , wherein the proximal transverse fixation system and / or the distal transverse fixation system are identical.

5. The device of claim 1 , wherein the proximal transverse fixation system and / or the distal transverse fixation system are different.

6. 6. The device of claim 1 , wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, comprise a solid or hollow cylinder made of a biocompatible material.

7. 7. The device of any one of claims 1 to 6, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, comprise a biocompatible material selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, ceramics, composites, hydroxyapatite (HA) coatings, nickel-free superelastic metal alloys, polyetheretherketone (PEEK), silicone, stainless steel, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), other materials capable of promoting bone regeneration, or materials derived therefrom, and combinations thereof.

8. The device of claim 1 , wherein the proximal transverse fixation system and / or the distal transverse fixation system independently or simultaneously comprise a material that promotes bone regeneration.

9. 9. The device of any one of claims 1 to 8, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, comprise a material that promotes bone regeneration selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, ceramics, composite materials, hydroxyapatite (HA) coatings, nickel-free superelastic metal alloys, polyetheretherketone (PEEK), silicone, stainless steel, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), other materials capable of promoting bone regeneration or materials derived therefrom, and combinations thereof.

10. 10. The device according to any one of claims 1 to 9, wherein the proximal transverse fixation system and / or the distal transverse fixation system are independently or simultaneously attached into the bone using any fixation method.

11. 11. The device according to any one of claims 1 to 10, wherein the proximal transverse fixation system and / or the distal transverse fixation system are independently or simultaneously mounted directly into the bone without a rod or sleeve.

12. 12. The device of any one of claims 1 to 11, wherein the proximal transverse fixation system and / or the distal transverse fixation system are attached into the bone using a fixation method selected from the group consisting of: cemented, uncemented, osseointegrated, osseointegrated with surface treatment or patterning to enhance bone ingrowth, press-fit, threaded, fluted, capped, screw-capped, pinned, other locking systems, and combinations thereof, independently or simultaneously.

13. 13. The device of any one of claims 1 to 12, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, include surface patterning to enhance natural bone ingrowth for anchoring into bone.

14. 14. The device of any one of claims 1 to 13, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, comprise a plurality of individual barbs of sufficient quantity and placement to impart stability within the patient's cancellous bone.

15. 15. The device of any one of claims 1 to 14, wherein the proximal and / or distal transverse fixation systems include barbs that are configured and manufactured to break away under specific controlled mechanical action, either independently or simultaneously.

16. 16. The device of claim 1, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, comprise concentric fluting.

17. 17. The device of any one of claims 1 to 16, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, further comprise concentric fluting, the fluting being pitched in the direction of insertion to prevent dislocation in the direction of extraction.

18. the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, include a cannulated anchor including a hollow shaft and a slot, the slot being wide enough to allow both a first barrel shape at a proximal edge of the flexible connector and a second barrel shape at a distal edge of the flexible connector to pass through the slot and into a joint cavity; 18. The device of claim 1, whereby the flexible connector is secured within the hollow shaft incorporating a first barrel shape that is thickened at a proximal edge of the flexible connector and a second barrel shape that is thickened at a distal edge of the flexible connector.

19. the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, include a cannulated anchor including a hollow shaft and a slot, the slot being wide enough to allow both a first barrel shape at a proximal edge of the flexible connector and a second barrel shape at a distal edge of the flexible connector to pass through the slot and into a joint cavity; whereby the flexible connector is secured within the hollow shaft incorporating a first barrel shape thickened at a proximal edge of the flexible connector and a second barrel shape thickened at a distal edge of the flexible connector; 19. The device of any one of claims 1 to 18, wherein the proximal transverse fixation system and / or the distal transverse fixation system independently or simultaneously include crimping flanges, wide flange screws, magnetic materials, biometric monitoring capabilities, and / or bone scaffold integration.

20. 20. The device of any one of claims 1 to 19, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, include a rod attached to a flexible connector by a cannulated screw anchor with a longitudinal slot with an arcuate opening of approximately 0.2 radians.

21. 21. The device of any one of claims 1 to 20, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, include a rod attached to a flexible connector comprising a hollow cylinder having an arcuate opening of about 0.2 radians and having generally parallel flanges protruding from an edge of the cylinder, the flanges configured to secure the flexible connector within a cross-sectional profile of the hollow cylinder.

22. 22. The device of any one of claims 1 to 21, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, comprise a maximum length that does not exceed an intracortical dimension measured in the coronal plane of the patient's bone at the site of implantation.

23. 23. The device of any one of claims 1 to 22, wherein the proximal transverse fixation system and / or the distal transverse fixation system, independently or simultaneously, include a maximum dimension measured in the sagittal plane that does not exceed about 70% of the bone dimension measured in the sagittal plane at the site of implantation in the patient after sectioning or debridement, such that sufficient remaining bone prevents bone fracture under normal force loading.

24. 24. The device of any one of claims 1 to 23, wherein the proximal and / or distal transverse fixation systems independently or simultaneously include one or more crimping flanges for attaching a proximal and / or distal fixation rod to the flexible connector.

25. 25. The device of any one of claims 1 to 24, wherein the proximal transverse fixation system and / or the distal transverse fixation system independently or simultaneously comprise an osseointegrated surface treatment.

26. 26. The device of any one of claims 1 to 25, wherein the flexible connector is attached directly into a prepared bone.

27. 27. The device of any one of claims 1 to 26, wherein the flexible connector is attached into the bone using a rod and sleeve, attached into the bone using an anchor, and / or attached into the bone using a cannulated anchor.

28. the proximal transverse fixation system and / or the distal transverse fixation system includes an anchor device configured in any shape selected from the group consisting of smooth, barbed, breakaway barbed, threaded screws, threaded screws with various pitches, threaded screws with various head types, threaded screws with various shank diameters, threaded screws with various thread diameters, threaded screws with various tip and crest profiles, threaded screws with various thread angles, concave fluting, concentric fluting, pitched fluting, longitudinal fluting, caps mechanically fastened to cortical bone using screws or pins, screw caps, hinged caps, cufflink caps, magnetic caps, osseointegrated bone caps, and combinations thereof; 28. The device of any one of claims 1 to 27, wherein the anchor device is configured to engage cortical bone only at the implantation surface or additionally engages cortical bone at an opposite end of the anchor device.

29. 29. The device of any one of claims 1 to 28, wherein the flexible connector is attached to the bone using an anchor.

30. 30. The device of any one of claims 1 to 29, wherein the flexible connector is attached to the bone using a cannulated anchor.

31. 31. The device of any one of claims 1 to 30, wherein the flexible connector is attached to the bone using a cannulated anchor, the cannulated anchor further comprising a wide flange screw to maximize a contact surface area with the bone into which the cannulated anchor is inserted.

32. 32. The device of any one of claims 1 to 31, wherein the flexible connector is attached to the bone using a cannulated anchor, the cannulated anchor being constructed from a biocompatible material selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, ceramics, composites, hydroxyapatite (HA) coatings, nickel-free superelastic metal alloys, polyetheretherketone (PEEK), silicone, stainless steel, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), other materials capable of promoting bone regeneration, or materials derived therefrom, and combinations thereof.

33. 33. The device of any one of claims 1 to 32, wherein the flexible connector is attached to the bone using a cannulated anchor, the cannulated anchor having a crystalline surface treatment to promote osseointegration of the cannulated anchor in cancellous bone.

34. 34. The device of any one of claims 1 to 33, wherein the flexible connector is attached to the bone using a cannulated anchor, the cannulated anchor having a varying pitch and / or a varying diameter.

35. 35. The device of any one of claims 1 to 34, wherein the flexible connector is attached to the bone using an anchor, the anchor being a cap mechanically fastened to the cortical bone to prevent lateral movement.

36. 36. The device of any one of claims 1 to 35, wherein the flexible connector is attached to the bone using an anchor, the anchor comprising an osseointegrated cortical bone cap.

37. 37. The device of any one of claims 1 to 36, wherein the flexible connector is attached to the bone using an anchor, the anchor comprising bone material that is fitted into a cortical divot flush with the surface of the cortical bone above the rod heads after insertion of the flexible connector into both anchor rods.

38. 38. The device of any one of claims 1 to 37, wherein the flexible connector is attached to the bone using an anchor, the anchor being a temporary fixation of the cortical bone cap using a biodegradable material dimensionally larger than the cortical bone cap that is mechanically fastened to adjacent stable cortical bone to secure the cortical bone cap until osseointegration is achieved.

39. 39. The device of any one of claims 1 to 38, wherein the flexible connector is attached to the bone using an anchor, the anchor being a wide flange cap that is screwed or locked into the head of an anchor rod and mechanically fastened to the cortical bone using a screw.

40. 40. The device of any one of claims 1 to 39, wherein the proximal and / or distal transverse fixation systems are independently or simultaneously attached to bone using anchors, which are flexible connectors that are press fit directly into bone.

41. 41. The device of any one of claims 1 to 40, wherein the flexible connector is attached to the bone using an anchor, the anchor being a flexible connector comprising an expanding hydrogel composite that is press-fit directly into the bone.

42. 42. The device of any one of claims 1 to 41, wherein the flexible connector is attached to the bone using an anchor, the anchor being a flexible connector that is press fit directly into the bone along with an expanding hydrogel composite, increasing stability as the expanding hydrogel composite hardens.

43. 43. The device of any one of claims 1 to 42, wherein the flexible connector is attached to the bone using an anchor, the anchor being made from a magnetic material.

44. 44. The device of any one of claims 1 to 43, wherein the flexible connector is attached to bone using an anchor, the anchor having biometric monitoring capability.

45. 45. The device of any one of claims 1 to 44, wherein the flexible connector is attached to the bone using an anchor, the anchor including bone scaffold integration.

46. 46. ​​The device of any one of claims 1 to 45, wherein the flexible connector is attached to the bone using an anchor, the anchor including a barb configured to break away in response to the application of a specific, controlled mechanical action.

47. 47. The device of any one of claims 1 to 46, further comprising a first integrally woven sleeve at a proximal end of the flexible connector for receiving and holding a proximal fixation rod and a second integrally woven sleeve at a distal end of the flexible connector for receiving and holding a distal fixation rod.

48. 48. The device of claim 47, wherein the first integrally woven sleeve and the second integrally woven sleeve are independently or simultaneously barbed.

49. 49. The device of claim 47 or 48, wherein the proximal fixation rod and / or the distal fixation rod are barbed, independently or simultaneously.

50. 50. The device of any one of claims 47 to 49, wherein the first integrally woven sleeve and the second integrally woven sleeve, independently or simultaneously, are smooth.

51. 51. The device of any one of claims 47 to 50, wherein the proximal fixation rod and / or the distal fixation rod, independently or simultaneously, are smooth.

52. 52. The device of any one of claims 47 to 51, wherein the proximal fixation rod and / or the distal fixation rod, independently or simultaneously, further comprise an anti-pullout peg.

53. 53. The device of any one of claims 1 to 52, wherein the flexible connector comprises a fatigue resistant biocompatible material.

54. 54. The device of any one of claims 1 to 53, wherein the flexible connector comprises a fatigue resistant biocompatible material selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, composite materials, elastomeric polymers, hydroxyapatite (HA) coatings, nickel-free superelastic metal alloys, nitinol, internal shape memory alloys, polyetheretherketone (PEEK), silicone, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), engineered polymers, or materials derived therefrom, and combinations thereof.

55. 55. The device of any one of claims 1 to 54, wherein the flexible connector comprises a fatigue resistant biocompatible material, the fatigue resistant biocompatible material being braided nanofiber elements woven in a two-dimensional and / or three-dimensional array.

56. 56. The device of any one of claims 1 to 55, wherein the flexible connector incorporates a range of strength, flexibility, elasticity, and other material properties to optimize the path of motion of the patient's phalanges and durability of the device.

57. 57. The device of any one of claims 1-56, wherein the flexible connector is constructed from a material configured to remain malleable after implantation.

58. 58. The device of any one of claims 1 to 57, wherein the device further comprises a malleable material between the anchor and the flexible connector.

59. 59. The device of any one of claims 1-58, wherein the flexible connector is in a kit that includes a variety of standard angled implants for correcting anchor misalignment.

60. 60. The device of any one of claims 1 to 59, wherein the flexible connector comprises a flexible material that allows smooth bending within the normal range of zero to one hundred degrees (0-100 degrees) when activated by a patient's flexor tendon system.

61. 61. The device of any one of claims 1 to 60, wherein the flexible connector is a flexible, planar component constructed from a fatigue-resistant biocompatible material configured to allow movement of the joint in the sagittal plane when activated by the patient's flexor tendon system.

62. 62. The device of any one of claims 1 to 61, wherein the flexible connector is a flexible, planar component constructed from a fatigue-resistant biocompatible material configured to allow for constrained accessory movement when subjected to external forces, such as when used to assist in gripping oddly shaped objects.

63. 63. The device of any one of claims 1 to 62, wherein the width of the flexible connector does not exceed the intracortical dimension measured in the coronal plane of the patient's bone at the site of implantation.

64. 64. A device according to any one of claims 1 to 63, wherein the flexible connector is designed such that the path of movement in the sagittal plane follows an arcuate path described by a normal interphalangeal joint or an approximation thereof.

65. 65. The device of any one of claims 1 to 64, wherein the flexible connector is designed to limit movement in the coronal plane to a maximum of approximately 0 degrees of accessory movement.

66. 66. The device of any one of claims 1 to 65, wherein the flexible connector comprises woven or laminated components to produce a flexible mesh having a variety of dynamic qualities and fastening methods.

67. 67. The device of any one of claims 1 to 66, wherein the flexible connector includes woven or laminated components to create a flexible mesh with various dynamic qualities and fixation methods and is secured to the bones of the first and second phalanges using a fixation system comprised of rod pockets or sleeves that are integrally woven into the proximal and distal edges of the flexible connector.

68. 68. The device of any one of claims 1 to 67, wherein the flexible connector maintains proper joint spacing to prevent bone-to-bone contact of the articular surfaces of the first and second bones of the joint.

69. 69. The device of any one of claims 1 to 68, wherein the flexible connector is constructed using a plain weave and a wide cross-sectional profile for the warp components that run perpendicular to the fixation pins or rods in the implant device, achieving a spring mesh that imparts lateral stability and alignment in the coronal plane without relying on articular ligaments.

70. 70. The device of any one of claims 1 to 69, wherein the flexible connector is constructed using a weave pattern that changes length when tension is applied.

71. 71. The device of any one of claims 1 to 70, wherein the flexible connector comprises a spring mesh constructed using a bias weave of wide flat sections.

72. 72. The device of any one of claims 1 to 71, wherein the flexible connector comprises a unitary flexible having multiple weave patterns, laminations, or polymer curing formulations.

73. 73. The device of any one of claims 1 to 72, wherein the flexible connector comprises a fatigue resistant biocompatible material further comprising braided nanofiber elements.

74. 74. The device of any one of claims 1 to 73, wherein the flexible connector comprises an internal shape memory alloy.

75. 75. The device of any one of claims 1 to 74, wherein the flexible connector comprises an internal shape memory alloy comprising Nitinol.

76. 76. The device of any one of claims 1 to 75, wherein the flexible connector comprises an internal reinforcing textile matrix.

77. 77. The device of any one of claims 1 to 76, wherein the flexible connector comprises braided nanofiber elements woven in a two-dimensional array.

78. 78. The device of any one of claims 1 to 77, wherein the flexible connector comprises braided nanofiber elements woven in a three-dimensional array.

79. 79. The device of any one of claims 1 to 78, wherein the flexible connector comprises fiber diameters or cross-sectional profiles specified to deliver an appropriate Young's modulus of elasticity to a weave pattern to allow stretch capacity at bending of approximately 25% of the unbent mesh length.

80. 80. The device of any one of claims 1 to 79, wherein the flexible connector is constructed using an engineered polymer.

81. 81. The device of any one of claims 1 to 80, wherein the flexible connector comprises a polymer configured to allow translational and elastic movements that approximate the natural physiological movement of an interphalangeal joint.

82. 82. The device of claim 81, wherein the polymer is a silicone.

83. 83. The device of any one of claims 1 to 82, wherein the flexible connector comprises silicone printed with an engineered pattern to improve the response of the flexible connector to stress.

84. 84. The device of any one of claims 1 to 83, wherein the flexible connector comprises silicone printed with a graded density such that the flexible connector comprises a higher density in or near a fixation system and a lower density in different parts of the flexible connector where greater flexibility is required to achieve a desired trajectory path of movement.

85. 85. The device of any one of claims 1 to 84, wherein the flexible connector is a polymer connector and includes a bumper flange oriented in a perpendicular manner relative to a coronal plane of the polymer connector to prevent bone-to-bone contact.

86. 86. The device of any one of claims 1 to 85, wherein the flexible connector is a polymer connector, the polymer connector including a bumper flange oriented perpendicular to the coronal plane of the polymer connector to prevent bone-to-bone contact, and further, the bumper flange is gel filled to enable dynamic response under a variety of tensile and compressive conditions.

87. 87. The device of any one of claims 1 to 86, wherein the flexible connector is a polymer connector and includes a bumper flange oriented perpendicular to a coronal plane of the polymer connector to prevent bone-to-bone contact, and further wherein the bumper flange includes a hollow or gel-filled portion to allow translation of the second bone relative to the first bone along an arc of a motion trajectory.

88. 88. The device of any one of claims 1 to 87, wherein the flexible connector comprises a biocompatible material that is fatigue resistant, the fatigue resistant biocompatible material comprising at least two different thicknesses.

89. 89. The device of any one of claims 1 to 88, wherein the flexible connector comprises a fatigue resistant biocompatible material that includes at least two different widths.

90. 90. The device of any one of claims 1 to 89, wherein the flexible connector comprises a fatigue resistant biocompatible material further comprising braided nanofiber elements.

91. 91. The device of any one of claims 1 to 90, wherein the flexible connector comprises a fatigue resistant material formed into a barrel shape that is thickened at its proximal and distal edges.

92. 92. The device of any one of claims 1 to 91, wherein the flexible connector comprises a fatigue resistant biocompatible material configured to bend along a predetermined path when stressed by an externally applied bending force, and further configured to return to a straight position when released from the externally applied bending force.

93. 93. The device of any one of claims 1 to 92, wherein the flexible connector comprises a unitary flexible having multiple weave patterns, laminations, or polymer curing formulations.

94. 94. The device of any one of claims 1-93, wherein the flexible connector has in situ malleability that is adjustable after implantation.

95. 95. The device of any one of claims 1 to 94, wherein the flexible connector has an inherent adjustability that can correct misalignment caused by a non-parallel relationship of the proximal and distal anchors.

96. 96. The device of any one of claims 1 to 95, wherein the flexible connector comprises a malleable material between an anchor and the flexible connector.

97. 97. The device of any one of claims 1 to 96, wherein the flexible connector is malleable due to variable density, hardening, material properties, construction, geometry, manufacturing process, and / or other factors.

98. 98. The device of any one of claims 1 to 97, wherein the flexible connector comprises a beam without bumpers; is capable of providing a stenting behavior to keep bone surfaces apart from one another, is capable of having memory to return to a pre-flexed neutral bend angle; and / or is capable of having a graduated or variable density with variable properties of strength and flexibility.

99. 99. The device of any one of claims 1-98, wherein the flexible connector is in a kit containing a plurality of standard variously angled implants for correcting anchor misalignment.

100. 100. The device of any one of claims 1 to 99, wherein the flexible connector is in a kit including a plurality of flexible connectors having various pre-bent neutral bend angles.

101. 1. A surgical procedure for implanting a stemless implantable device for joint arthroplasty, said surgical procedure comprising: - selecting a patient in need of implantation of a stemless implantable device for joint arthroplasty; - providing a stemless implantable device for joint arthroplasty according to any one of claims 1 to 100; - implanting said stemless implantable device for joint arthroplasty into said patient; Including, surgical procedures.

102. The surgical procedure comprises: - performing a minimally invasive lateral incision at the patient's implant site; - preparing a joint capsule and one or more phalanges at the implant site; - press-fitting the lateral insert of the stemless implantable device for joint arthroplasty into the implant site or into a pre-fitted anchor system; - performing a surgical closure of the wound at the implant site; 102. The surgical procedure of claim 101, comprising:

103. 103. The surgical procedure of claim 101 or 102, wherein the step of preparing the joint capsule and phalanges includes resection of damaged cartilage and articular surfaces.

104. 104. The surgical procedure of any one of claims 101 to 103, further comprising the step of capping the countersunk anchor holes using resected bone.

105. 1. A system for attaching a rod to a flexible connector, the flexible connector comprising a hollow cylinder having an arcuate opening of approximately 0.2 radians and having generally parallel flanges protruding from edges of the rod, the flanges configured to secure the flexible connector within a cross-sectional profile of the hollow cylinder.

106. A system for attaching a flexible connector comprising a cannulated screw anchor with a longitudinal slot with an arcuate opening of approximately 0.2 radians.

107. 1. A stemless implantable device for joint arthroplasty, the stemless implantable device comprising: - a flexible connector; - a proximal transverse fixation system; - Distal transverse fixation system and Including, The device, wherein the flexible connector is attached at one end to the proximal transverse fixation system and at another end to the distal transverse fixation system.

108. The flexible connector comprises: a first barrel shape having a thickened configuration at a proximal edge of the flexible connector; a thickened second barrel shape at a distal edge of the flexible connector; Dorsal bumper and; A palmar bumper; Including, 108. The device of claim 107, wherein the dorsal bumper and the palmar bumper are oriented transversely to a coronal plane of the flexible connector.

109. 109. The device of claim 107 or 108, wherein at least one of the proximal transverse fixation system or the distal transverse fixation system includes a thickened, barrel-shaped portion of the flexible connector configured to be anchored within a joint cavity of a phalangeal bone.

110. 109. The device of claim 107 or 108, wherein at least one of the proximal transverse fixation system or the distal transverse fixation system includes a cannulated anchor comprising a hollow shaft having an internal cannulated space and a slot configured to receive the flexible connector through the slot and into the internal cannulated space, thereby securing the flexible connector within the hollow shaft.

111. 109. The device of claim 107 or 108, wherein at least one of the proximal or distal transverse fixation systems includes a sleeve formed on an end of the flexible connector and a rod configured to be retained within the sleeve.

112. 112. The device of any one of claims 107 to 111, wherein at least one of the proximal transverse fixation system or the distal transverse fixation system comprises a biocompatible material.

113. The device of claim 112, wherein the biocompatible material is a biocompatible polymer.

114. 113. The device of claim 112, wherein the biocompatible material is selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, ceramics, composites, hydroxyapatite (HA) coatings, superelastic metal alloys, polyetheretherketone (PEEK), silicone, stainless steel, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), polyethylene (PE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA), fluorinated ethylene propylene (FEP), and combinations thereof.

115. 115. The device of any one of claims 107 to 114, wherein at least one of the proximal transverse fixation system or the distal transverse fixation system is attached into the bone using a fixation method selected from the group consisting of cemented, uncemented, osseointegrated, osseointegrated with surface treatment or patterning to enhance bone ingrowth, press-fit, threaded, fluted, capped, screw-capped, pinned, and combinations thereof.

116. 116. The device of any one of claims 107-115, wherein the dorsal and palmar bumpers are gel filled.

117. 117. A device as described in any one of claims 107 to 116, wherein the dorsal bumper and the palmar bumper include hollow portions.

118. 118. The device of any one of claims 107 to 117, wherein the flexible connector comprises a solid insert, a mesh insert, or a braided nanofiber element.

119. 119. The device of any one of claims 107 to 118, wherein the flexible connector comprises a polymer including silicone, an elastomeric polymer, polyetherketone, ultra-high molecular weight polyethylene, polyethylene, polytetrafluoroethylene, polyfluoroalkoxy, fluorinated ethylene propylene, or a combination thereof.

120. 120. The device of claim 119, wherein the flexible connector comprises a graduated density such that the flexible connector comprises a higher density at proximal and distal edges and a lower density in different parts of the flexible connector.

121. 121. The device of any one of claims 107 to 120, wherein the cannulated anchor includes threads on an exterior surface of the cannulated anchor configured to mount the cannulated anchor into bone.

122. 122. The device of any one of claims 107 to 121, wherein the slot has a wedge shape that facilitates a predetermined amount of rotation of the flexible connector relative to the cannulated anchor but does not allow disengagement of the flexible connector from the cannulated anchor.

123. 123. The device of any one of claims 107 to 122, wherein the device further comprises a threaded end cap, the cannulated anchor comprising an internal thread that facilitates attachment of the end cap via the internal thread of the cannulated anchor.

124. 124. The device of any one of claims 107 to 123, wherein at least one of the proximal transverse fixation system or the distal transverse fixation system further comprises a smooth rod, a barbed rod, a cap, a screw cap, a cap mechanically fastenable to cortical bone using a screw or pin, a screw cap, a hinged cap, a cuff link cap, a magnetic cap, an osseointegrated bone cap, a pin, a crimping flange, a wide flange screw, a magnetic material, a bone scaffold, a surface treatment or pattern to enhance bone ingrowth, a smooth surface, a barbed surface, a breakaway barb, a thread, a threaded screw, a threaded screw with varying pitch, a threaded screw with varying head types, a threaded screw with varying shank diameters, a threaded screw with varying thread diameters, a threaded screw with varying tip and crest profiles, a threaded screw with varying thread angles, concave fluting, concentric fluting, pitched fluting, longitudinal fluting, or a combination thereof.

125. 1. An implantable device for joint arthroplasty, the device comprising: A flexible connector; a first barrel shape having a thickened configuration at a proximal edge of the flexible connector; a thickened second barrel shape at a distal edge of the flexible connector; Dorsal bumper and; a palmar bumper, the dorsal bumper and the palmar bumper being oriented transversely to a coronal plane of the flexible connector; Including, the device.

126. 126. The device of claim 125, wherein the dorsal and palmar bumpers are gel filled.

127. 127. The device of claim 125 or 126, wherein the dorsal and palmar bumpers include hollow portions.

128. 128. The device of any one of claims 125 to 127, wherein the flexible connector comprises a polymer.

129. 129. The device of claim 128, wherein the polymer comprises silicone, an elastomeric polymer, polyetherketone, ultra-high molecular weight polyethylene, polyethylene, polytetrafluoroethylene, polyfluoroalkoxy, fluorinated ethylene propylene, or a combination thereof.

130. 130. The device of claim 129, wherein the silicone includes an engineered pattern to affect the response of the flexible connector to stress.

131. 130. The device of claim 129, wherein the silicone comprises a graded density such that the flexible connector comprises a higher density at proximal and distal edges and a lower density in different parts of the flexible connector.

132. 132. The device of any one of claims 125-131, wherein the flexible connector comprises a solid insert, a mesh insert, or a braided nanofiber element.

133. 133. The device of any one of claims 125 to 132, further comprising a sleeve formed at an end of the flexible connector configured to receive a rod to be held within the sleeve.

134. 1. An implantable device for joint arthroplasty, the device comprising: a cannulated anchor sized and configured to fit within a joint cavity, the cannulated anchor including a hollow shaft having an interior cannulated space and a longitudinal slot; The device, wherein the longitudinal slot is sized and configured to facilitate passage of a flexible connector through the longitudinal slot and into the internal cannula space, thereby securing the flexible connector within the hollow shaft.

135. The device of claim 134, further comprising a cap, a screw cap, a cap that can be mechanically fastened to cortical bone using a screw or pin, a screw cap, a hinged cap, a cuff link cap, a magnetic cap, an osseointegrated bone cap, a pin, a crimping flange, a wide flange screw, a magnetic material, a bone scaffold, or a combination thereof.

136. 136. The device of claim 134 or 135, wherein the cannulated anchor includes a surface treatment or pattern to enhance bone ingrowth, a smooth surface, a barbed surface, breakaway barbs, threads, threaded screws, threaded screws with varying pitch, threaded screws with varying head types, threaded screws with varying shank diameters, threaded screws with varying thread diameters, threaded screws with varying tip and crest profiles, threaded screws with varying thread angles, concave fluting, concentric fluting, pitched fluting, longitudinal fluting, or combinations thereof.

137. 137. The device of any one of claims 134 to 136, wherein the cannulated anchor comprises a biocompatible material.

138. The device of claim 137, wherein the biocompatible material is a biocompatible polymer.

139. 138. The device of claim 137, wherein the biocompatible material is selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, ceramics, composites, hydroxyapatite (HA) coatings, superelastic metal alloys, polyetheretherketone (PEEK), silicone, stainless steel, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), polyethylene (PE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA), fluorinated ethylene propylene (FEP), and combinations thereof.

140. 140. The device of any one of claims 134 to 139, wherein the cannulated anchor includes a crystalline surface treatment operable to promote osseointegration of the cannulated anchor within cancellous bone.

141. 141. The device of any one of claims 134 to 140, wherein the longitudinal slot has an arcuate opening of about 0.2 radians to 0.5 radians.

142. 142. The device of any one of claims 134 to 141, wherein the longitudinal slot has a wedge shape that facilitates a predetermined amount of rotation of the flexible connector relative to the cannulated anchor but does not allow disengagement of the flexible connector from the cannulated anchor.

143. 143. The device of any one of claims 134 to 142, wherein the cannulated anchor comprises a cannulated screw anchor.

144. 144. The device of claim 143, wherein the cannulated anchor includes a guide dot adjacent to the longitudinal slot.

145. 144. The device of claim 143, further comprising a threaded end cap, the cannulated anchor comprising an internal thread that facilitates attachment of the end cap via the internal thread of the cannulated anchor.

146. 146. The device of claim 145, wherein the end cap is magnetic.

147. 1. An implantable device for joint arthroplasty, the device comprising: a flexible connector, the flexible connector including a first barrel shape configured with a thickening at a proximal edge of the flexible connector and a second barrel shape configured with a thickening at a distal edge of the flexible connector; a proximal cannulated anchor including a proximal hollow shaft having a proximal internal cannulated space and a proximal slot configured to receive the flexible connector through the proximal slot and into the proximal internal cannulated space, thereby anchoring the thickened configured first barrel shape within the proximal hollow shaft; a distal cannulated anchor including a distal hollow shaft, the distal hollow shaft having a distal inner cannulated space and a distal slot, the distal slot configured to receive the flexible connector through the distal slot and into the distal inner cannulated space, thereby anchoring the thickened configured second barrel shape within the distal hollow shaft; Including, the device.

148. The flexible connector comprises: Dorsal bumper and; a palmar bumper, the dorsal bumper and the palmar bumper being oriented transversely to a coronal plane of the flexible connector; The device of claim 147, comprising:

149. 149. The device of claim 148, wherein the dorsal and palmar bumpers are gel filled.

150. 149. The device of claim 148, wherein the dorsal bumper and the palmar bumper include hollow portions.

151. 151. The device of any one of claims 147 to 150, wherein the flexible connector comprises a polymer.

152. 152. The device of claim 151, wherein the polymer comprises silicone, an elastomeric polymer, polyetherketone, ultra-high molecular weight polyethylene, polyethylene, polytetrafluoroethylene, polyfluoroalkoxy, fluorinated ethylene propylene, or a combination thereof.

153. 153. The device of claim 152, wherein the silicone includes an engineered pattern to affect the response of the flexible connector to stress.

154. 153. The device of claim 152, wherein the silicone comprises a graded density such that the flexible connector comprises a higher density at proximal and distal edges and a lower density in different parts of the flexible connector.

155. 155. The device of any one of claims 147-154, wherein the flexible connector comprises at least one of a solid insert, a mesh insert, or a braided nanofiber element.

156. The device of any one of claims 147 to 155, further comprising a smooth rod, a barbed rod, a cap, a screw cap, a cap that can be mechanically fastened to cortical bone using a screw or pin, a screw cap, a hinged cap, a cufflink cap, a magnetic cap, an osseointegrated bone cap, a pin, a crimping flange, a wide flange screw, a magnetic material, a bone scaffold, or a combination thereof.

157. 157. The device of any one of claims 147 to 156, wherein at least one of the proximal cannulated anchor or the distal cannulated anchor comprises a surface treatment or pattern to enhance bone ingrowth, a smooth surface, a barbed surface, a breakaway barb, a thread, a threaded screw, a threaded screw with varying pitch, a threaded screw with varying head types, a threaded screw with varying shank diameters, a threaded screw with varying thread diameters, a threaded screw with varying tip and crest profiles, a threaded screw with varying thread angles, concave fluting, concentric fluting, pitched fluting, longitudinal fluting, or a combination thereof.

158. 158. The device of any one of claims 147 to 157, wherein at least one of the proximal cannulated anchor or the distal cannulated anchor comprises a biocompatible material.

159. The device of claim 158, wherein the biocompatible material is a biocompatible polymer.

160. 159. The device of claim 158, wherein the biocompatible material is selected from the group consisting of medical grade plastics, bioactive materials, carbon nanofibers, carbon plates, carbon strips, ceramics, composites, hydroxyapatite (HA) coatings, superelastic metal alloys, polyetheretherketone (PEEK), silicone, stainless steel, titanium alloys, titanium, ultra-high molecular weight polyethylene (UHMWPE), polyethylene (PE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA), fluorinated ethylene propylene (FEP), and combinations thereof.

161. The device of any one of claims 147 to 160, wherein at least one of the proximal cannulated anchor or the distal cannulated anchor includes a crystalline surface treatment that can function to promote osseointegration of the anchor within cancellous bone.

162. 162. The device of any one of claims 147-161, wherein at least one of the proximal slot or the distal slot has an arcuate opening of approximately 0.2 radians to 0.5 radians.

163. 163. The device of any one of claims 147 to 162, wherein at least one of the proximal slot or the distal slot has a wedge shape that facilitates a predetermined amount of rotation of the flexible connector relative to the cannulated anchor but does not allow disengagement of the flexible connector from the cannulated anchor.

164. 164. The device of any one of claims 147-163, wherein at least one of the proximal cannulated anchor or the distal cannulated anchor comprises a cannulated screw anchor.

165. 165. The device of claim 164, wherein at least one of the proximal cannulated anchor or the distal cannulated anchor includes a guide dot adjacent to a slot.

166. 165. The device of claim 164, further comprising a threaded end cap, wherein at least one of the proximal cannulated anchor or the distal cannulated anchor comprises an internal thread that facilitates attachment of the end cap via the internal thread.

167. 167. The device of claim 166, wherein the end cap is magnetic.

168. An interphalangeal joint, the interphalangeal joint comprising: a first phalange having a first joint cavity and a first slot, the first joint cavity being formed by drilling a first bore in the first phalange parallel to an approximate axis of rotation of the joint, and the first slot being formed by sawing a first channel into the first bore; a second phalange having a second joint cavity and a second slot, the second joint cavity being formed by drilling a second bore in the second phalange parallel to the approximate axis of rotation of the joint, and the second slot being formed by sawing a second channel into the second bore; A flexible connector, the flexible connector including a first barrel shape with a thickened configuration at a proximal edge of the flexible connector and a second barrel shape with a thickened configuration at a distal edge of the flexible connector, the first barrel shape with a thickened configuration being secured in the first joint cavity and the second barrel shape with a thickened configuration being secured in the second joint cavity. Including the interphalangeal joints.

169. 169. The interphalangeal joint of claim 168, wherein the width of the flexible connector does not exceed an intracortical dimension measured in the coronal plane of the first phalange or the second phalange.

170. 170. The interphalangeal joint of claim 168 or 169, wherein the flexible connector includes a dorsal bumper and a palmar bumper, the dorsal bumper and the palmar bumper being oriented transversely relative to a coronal plane of the flexible connector.

171. 171. The interphalangeal joint of claim 170, wherein the dorsal and palmar bumpers are gel filled.

172. 171. The interphalangeal joint of claim 170, wherein the dorsal bumper and the palmar bumper include hollow portions.

173. 173. The interphalangeal joint of any one of claims 168 to 172, wherein the flexible connector comprises a polymer.

174. The interphalangeal joint of claim 173, wherein the polymer is silicone, an elastomeric polymer, polyetherketone, ultra-high molecular weight polyethylene, polyethylene, polytetrafluoroethylene, polyfluoroalkoxy, fluorinated ethylene propylene, or a combination thereof.

175. The interphalangeal joint of claim 174, wherein the silicone includes an engineered pattern to affect the response of the flexible connector to stress.

176. 175. The interphalangeal joint of claim 174, wherein the silicone comprises a graduated density such that the flexible connector comprises a higher density at proximal and distal edges and a lower density in different parts of the flexible connector.

177. The interphalangeal joint of any one of claims 168 to 176, wherein the flexible connector comprises a solid insert, a mesh insert, or a braided nanofiber element.

178. 178. The interphalangeal joint of any one of claims 168 to 177, wherein at least one of the first slot or the second slot has an arc opening of approximately 0.2 radians to 0.5 radians.

179. 179. The interphalangeal joint of any one of claims 168 to 178, wherein at least one of the first slot or the second slot has a wedge shape that facilitates a predetermined amount of rotation of the flexible connector relative to the first or second phalanges but does not allow disengagement of the flexible connector from the first or second phalanges.

180. 180. The interphalangeal joint of any one of claims 168 to 179, wherein the flexible connector is in direct contact with at least one of the first phalange or the second phalange without an anchor.

181. 1. A method of configuring an implantable device for joint arthroplasty, the method comprising: providing a flexible connector, the flexible connector including a first barrel shape configured with a thickening at a proximal edge of the flexible connector and a second barrel shape configured with a thickening at a distal edge of the flexible connector; providing a proximal cannulated anchor including a proximal hollow shaft having a proximal interior cannulated space and a proximal slot; providing a distal cannulated anchor including a distal hollow shaft having a distal interior cannulated space and a distal slot; configuring the flexible connector to pass through the proximal slot and into the proximal inner cannula space; configuring the thickened first barrel shape to be secured within the proximal hollow shaft; configuring the flexible connector to pass through the distal slot and into the distal inner cannula space; configuring the thickened second barrel shape to be secured within the distal hollow shaft; A method comprising:

182. 182. The method of claim 181, further comprising configuring the flexible connector with a dorsal bumper and a palmar bumper, the dorsal bumper and the palmar bumper being oriented transversely relative to a coronal plane of the flexible connector.

183. 183. The method of claim 181 or 182, further comprising configuring an end cap to be connected to at least one of the proximal cannulated anchor or the distal cannulated anchor.

184. 184. The method of any one of claims 181 to 183, the method further comprising configuring at least one of the proximal slot or the distal slot with a wedge shape that facilitates a predetermined amount of rotation of a flexible connector relative to at least one of the proximal cannulated anchor or the distal cannulated anchor, but does not allow disengagement of the flexible connector from at least one of the proximal cannulated anchor or the distal cannulated anchor.

185. 1. A surgical procedure for implanting an implantable device for joint arthroplasty, said surgical procedure comprising: selecting a patient in need of implantation of an implantable device for joint arthroplasty; Providing an implantable device for joint arthroplasty according to claim 107, claim 127, claim 134 or claim 147; and implanting the joint arthroplasty implantable device in the patient; Including, surgical procedures.

186. The surgical procedure comprises: performing a minimally invasive lateral incision at an implant site on the patient; preparing a joint capsule and one or more phalanges at the implant site; fitting the joint arthroplasty implantable device into the implant site; performing surgical closure of the wound at the implant site; 186. The surgical procedure of claim 185, comprising:

187. 187. The surgical procedure of claim 186, wherein the step of preparing the joint capsule and phalanges includes resection of damaged cartilage and articular surfaces.

188. 188. The surgical procedure of any one of claims 185 to 187, wherein the surgical procedure further comprises using resected bone to cap the countersunk anchor holes.

189. The surgical procedure comprises: drilling a first bore into a first phalange of the joint parallel to an approximate axis of rotation of the joint; forming a first slot in the first phalange by sawing a first channel into the first bore; drilling a second bore into a second phalange of the joint parallel to the approximate axis of rotation of the joint; forming a second slot in the second phalange by sawing a second channel into the second bore; 189. The surgical procedure of any one of claims 185 to 188, comprising:

190. 190. The surgical procedure of claim 189, further comprising the steps of inserting a first guidewire into the first phalange at a desired location in the first bore prior to drilling the first bore, and inserting a second guidewire into the second phalange at a desired location in the second bore prior to drilling the second bore.

191. 200. The surgical procedure of claim 190, further comprising aligning an external jig with the guidewire prior to drilling the first and second bores.

192. 192. The surgical procedure of any one of claims 185 to 191, wherein the step of implanting an implantable device for joint arthroplasty comprises attaching the flexible connector of the device of claim 1 directly to bone without an anchor.

193. 193. The surgical procedure of any one of claims 185 to 192, wherein the step of implanting the implantable device for joint arthroplasty comprises attaching a cannulated anchor of the device of claim 26 to the bone using a fixation method selected from the group consisting of cemented, uncemented, osseointegrated, osseointegrated with surface treatment or patterning to enhance bone ingrowth, press-fit, threaded, fluted, capped, screw-capped, pinned, and combinations thereof.

194. 200. The surgical procedure of claim 193, wherein the fixation method includes a plurality of individual barbs of sufficient quantity and placement to impart stability within the patient's cancellous bone.

195. 195. The surgical procedure of claim 193 or 194, wherein the fixation method includes barbs that are configured and manufactured to break away under specific controlled mechanical action.

196. 196. The surgical procedure of any one of claims 193 to 195, wherein the fixation method includes concentric fluting, the fluting being pitched in the direction of insertion to prevent dislocation in the direction of extraction.

197. 202. The surgical procedure of any one of claims 193 to 196, further comprising mechanically fastening a cap to cortical bone to prevent lateral migration of the cannulated anchor.

198. 202. The surgical procedure of any one of claims 193 to 197, further comprising forming an osseointegrated cortical bone cap.

199. 200. The surgical procedure of any one of claims 193 to 198, further comprising the step of installing bone material in a cortical divot flush with the surface of the cortical bone over the cannulated anchor after inserting a flexible connector into the cannulated anchor.

200. 200. The surgical procedure of any one of claims 193 to 199, further comprising a step of temporarily fixing the cortical bone cap using a biodegradable material that is dimensionally larger than the cortical bone cap mechanically fastened to an adjacent stable cortical bone to anchor the cortical bone cap until osseointegration is achieved.

201. 201. The surgical procedure of any one of claims 193 to 200, wherein the surgical procedure includes pressing the cannulated anchor into bone.

202. 202. The surgical procedure of any one of claims 185 to 201, wherein the implantable device for joint arthroplasty includes the flexible connector, the width of the flexible connector not exceeding the intracortical dimension measured in the coronal aspect of the patient's bone at the site of implantation.

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