Implantable orthopedic device and kit for repairing anatomical joint

Abstract

The present invention generally relates to an implantable orthopedic device for repairing an anatomical joint and ameliorating joint conditions at a treatment site of a human or animal, and a kit for repairing an anatomical joint. The implantable orthopedic device comprises a first portion and a second portion, wherein a sidewall of the second portion comprises a protrusion; and wherein the sidewalls of the second portion include a plurality of second apertures between the protrusions, where the device has a width and a length, where the width and length of the device include an aspect ratio of between about 0.3 and 3.0, respectively; and wherein the sidewall of the second portion comprises one or more vascular grooves extending from the mating end to the leading end, the one or more vascular grooves providing a surface area for blood adhesion to promote capillary flow of blood towards the joint-facing end and the treatment site.

Description

[0001] This application is a divisional application of the invention patent application with application number 202210030973.4, application date November 23, 2016, and invention name “Implantable Orthopedic Device”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 260,030, filed on November 25, 2015, which is hereby incorporated by reference in its entirety for all purposes. Technical Field

[0004] The present invention generally relates to methods, systems and apparatus for repairing anatomical joints. For example, such repair may be required by trauma, disease or other conditions (i.e., genetic deformities), and may particularly include mammalian joints such as knees, shoulders, elbows, wrists, toes, hips, fingers, spine and / or ankles. Background Art

[0005] The knee joint is particularly susceptible to degeneration due to disease, trauma, and chronic repetitive use, ultimately leading to pain, swelling, and / or stiffness. Knee pain itself is a driver of various medical interventions and the associated treatment costs.

[0006] Normally, the knee joint experiences extensive motion and stress every day. In a healthy knee joint, the joint between the bones of the knee is lined with cartilage. This cartilage is used to keep the knee stable, reduce friction in the joint, and absorb shock. When this cartilage degenerates, it can cause serious problems. In some cases, patients may experience severe pain to the point where they are unable to walk or bear weight.

[0007] Patients most often seek treatment for osteoarthritis because of the pain and deterioration in quality of life it causes. Degenerative arthritis, or osteoarthritis, is a very common joint disease that affects an estimated 21 million Americans and may be part of a group of conditions known as metabolic syndrome. The disease is characterized by loss of cartilage in the joints, and symptoms often include pain and stiffness. Osteoarthritis can affect all joints in the body. The main goals of osteoarthritis treatment are to reduce or eliminate pain and restore normal joint function. Both nonsurgical and surgical treatments are currently available for this purpose, with the appropriate treatment selected based in part on the stage and / or severity of the disease.

[0008] Non-surgical treatments for knee osteoarthritis may include weight loss (for overweight patients), activity modification (low-impact exercises), quadriceps strengthening, patellar plastering, analgesic and anti-inflammatory medications, and injections of corticosteroids and / or viscosupplements. Non-surgical joint treatments typically involve drug interventions, such as administration of non-steroidal anti-inflammatory drugs or injections of hyaluronic acid-based products. These treatments are initially administered to patients with relatively few pain or joint complications. However, when non-surgical treatments prove ineffective, or for patients with severe pain or bone damage, surgical intervention is most likely required.

[0009] In addition to osteoarthritis, other conditions and diseases that impair the integrity and function of the knee and other human joints include osteochondrosis, chondromalacia patellae, isolated cartilage defect, juvenile idiopathic arthritis, ligamentous defect arthritis, osteonecrosis, osteochondritis dissecans, patellar instability, post-ligamentous arthritis, post-resection arthritis, post-meniscectomy joint disorder, post-traumatic arthritis, septic arthritis, and rheumatoid arthritis. Rheumatoid arthritis is an autoimmune disease characterized by the body's defense mechanism attacking healthy joint tissue. Genetic defects may also cause a person to experience joint problems.

[0010] Isolated articular cartilage defects and systemic cartilage diseases, arthrosis, and arthritis each have several surgical treatment options that attempt to mimic or recreate normal anatomy and joint mechanics and / or relieve symptoms of discomfort, instability, and pain. Isolated disorders often progress to systemic disease or arthritis. Systemic arthritis may also develop without a known precursor to the isolated disorder. Arthritis may present as uni-, bi-, or tri-compartmental disease.

[0011] Unicompartmental arthritis is not usually a good surgical option for smaller, isolated joint defects. There is often increased axial deformity and misalignment due to advanced cartilage degeneration and joint space narrowing. Surgical options include osteotomy or unicompartmental replacement. Options for bicompartmental or tricompartmental arthritis are combined surgery or total knee replacement.

[0012] Cartilage diseases have been addressed previously by various methods of replacing or substituting damaged cartilage. Microfracture or abrasion plasty is a form of stimulation of exposed bone to form replacement fibrous cartilage, but the resulting material is inferior to natural cartilage.

[0013] Treatment of cartilage disease has also been attempted by realigning the joint with osteotomy. This relieves the overloaded compartment, shifting stress to the less affected compartment. The success of this approach involves avoiding nonunion and other complications, requiring prolonged nonweightbearing activity, and requiring 8 to 12 months to achieve clinical benefit. Only a large proportion of patients with unicompartmental disease are candidates for this treatment. Osteotomy also complicates subsequent joint replacement.

[0014] Osteochondral implants replace diseased cartilage and the accompanying embolization of subchondral bone with an implant from the patient or a human cadaver. This implant procedure works well for small discrete injuries, but does not address larger injuries, bipolar disease, and diffuse disease well. Chondrocyte implants harvest the patient's chondrocytes, grow them, reimplant them into the bone bed, and cover them with a periosteal patch. Each of the above techniques is most effective for small volume injuries, unipolar defects, and major femoral condyle injuries. There are only poor results for patellofemoral disease and bilateral tibial disease.

[0015] Surgical treatments such as high tibial osteotomy (HTO), total knee arthroplasty (TKA), or total knee replacement (TKR) are often recommended for patients with severe pain associated with osteoarthritis, especially when other non-invasive options have failed.

[0016] Arthroscopies are used to treat other pains caused by arthritis, namely loose bodies, loose or worn cartilage, meniscal tears, and synovitis. These are temporary measures (as the author of this article can personally attest having performed multiple arthroscopies).

[0017] The final stage of cartilage disease is total joint reconstruction. This type of surgery is associated with a longer recovery time and surgical risks. Because total joint prostheses are made of metal and plastic, revision surgery of worn areas carries an increased risk of complications compared to primary surgery.

[0018] All of the above-mentioned surgical procedures are relatively invasive, expensive and generally provide only short-term pain relief to the patient. Unfortunately, none of these procedures improve all of the above-mentioned joint conditions and diseases.

[0019] Little is known about the cause and progression of arthritis. Recently, more information about the onset and progression of the disease has been elucidated using current diagnostic techniques (such as MRI and bone imaging). In particular, it has been found that subchondral bone plays a significant and important role in the onset and progression of arthritis. Subchondral bone is located below the articular cartilage and provides support for the cartilage on the joint surface. Therefore, arthritis is not only a cartilage disease, but also a disease that affects the underlying subchondral bone. Most clinical studies to date have focused on cartilage regeneration / replacement, rather than on the state of underlying bone health.

[0020] Traditionally, cartilage was thought to be avascular, with nutrients diffusing from within the joint. However, research has confirmed that the subchondral bone is a key source of vascularity and nutritional support to the cartilage. As we age, the vascularity and structural support from the subchondral bone decreases, allowing arthritic disease to develop. As damage increases, the bone is unable to adequately repair itself, thereby starting a cycle of further destruction that interferes with the cartilage vascular supply and structural support. As a result, patients often experience a downward spiral of pain.

[0021] As cartilage wear occurs, the primary function of cartilage—providing a low-friction load-bearing surface and transferring stress to the underlying bone—is reduced. Bones are healthiest when they resist compressive stress. Shear stress from the joint is partially converted into compression and tension via the structure of the cartilage substrate. In addition, shear stress is mostly converted into longitudinal stress due to the ultra-low friction surface of cartilage on cartilage (its friction is about 20 times lower than ice on ice). The subchondral bone is the primary shock absorber of joint stress. Via its trabecular skeleton grid, stress is transferred to the outer cortex and ultimately dissipated. Cartilage itself provides amazing small shock absorption due to its shear thickness and mechanical properties.

[0022] Bones are the ultimate shock absorbers, and fractures are the unfortunate endpoint of force attenuation. Trabecular microfractures have been shown to occur at sites of bone stress in impact-loaded joints. Every joint has a physiological functional envelope. When this functional envelope is exceeded, the rate of damage exceeds the rate of repair. As cartilage disease progresses, the subchondral bone is unable to dissipate the shear stresses it encounters. Attempts to heal and remodel the subchondral bone are seen as arthritis progresses, including marked osteophyte formation, subchondral sclerosis, cyst formation, subchondral MRI-enhancing changes, and enhanced signal on bone scintigraphy. The joint deformities caused by these changes further increase joint reaction forces. Cartilage homeostasis is impaired in all aspects of the structural, vascular, neural, and trophic regions.

[0023] The clinical success of current cartilage surgery is limited because it is generally only applicable to small unipolar (one-sided joint) injuries of the femoral condyle. There is currently no treatment for bone edema or osteonecrosis of the knee.

[0024] Additional information related to attempts to solve these problems can be found, for example, in the following documents: U.S. Patents USRE43714, US2188631, US 4055862, US 4344193, US4431416, US 4502161, US 4654314, US4687675, US 4728332, US 4787848, US 4820156, US 4880429, US 4886456, US 4919667, US4963145, US 5007934, US 5026373, US 5171322, US 5176710, US 5306311, US 5344459, US5514141, US 5632745, US 5865849, US 5984970, US 6037519, US 6042610, US 6046379, US6093204, US 6149651, US 6193755, US 6206927, US 6447545, US 6530956, US 6540786, US6562071, US 6629997, US 6645251, US 6699252, US 6758865, US 6761739, US 6767369, US6783550, US 6793676, US 6855165, US 6911044, US 6923831、US 6994730, US 7066961, US7282063, US 7291169, US 7297161, US 7338524, US 7585311, US 7608105, US 80775563, US8317792, US 8480757, US 8623089, US 8608802, US 8753401, US 8753401, US 8968404, US9155625;US patent application publications: US20020173855, US20030040798, US20030109928, US2003083665, US20040006393, US20040133275, US20040199250, US20040243250, US20050004572, US20050033424, US20050043813, US20050055101, US20050060037, US20050171604, US20050209703 , US20050221703, US20050234549, US20050267584, US20050278025, US20060155287, US20060173542, US20060190078, US20070005 143. US20070078518, US20070179610, US20080077248, US20080119947, US20080215055, US20080262616, US20090024229, US20100 145451, US20110029081, US20110034930, US20110125264, US20120053588, US20120172880, US20130035764, US20140303629, US20 U S20140277544, US20130035561, US20140276845, US20140039454, US20130035764, US20140121708, US20120316513, US20140074103, US20130325126, US20140074117, US20110125264, US20140107781, US20110125157, US20120316571, US20160250026; European patent application: EP 0739631B1, EP1541095, EP1719532A3, EP 2174674B1, EP 2308027B1, EP2621411A2, EP 2717808 A2;and international patent applications: CA 2838816A1, WO 199624302A1, WO 200139694A1, WO 2007007106A1, WO2010065426A1, WO 2011063240A1, WO 2011063250A1, WO 2012170805A2, WO 2013137889A1, WO 2014145406A1, WO 2014145267A1, WO 2014152533A1, WO 2014159913A1, WO2014039998A1, WO 2014053913A2, WO 2014045124A2 and WO 2014074806A1. ;

[0025] Various methods, systems, and devices for repairing anatomical joint conditions, including some embodiments of the present invention, may mitigate or reduce the effects of, or even take advantage of, some or all of these potential problems.

[0026] Therefore, there is a reasonable need for cost-effective minimally invasive methods, systems and devices for repairing anatomical joints, including the human knee joint. This need is particularly acute in today's society with an aging population that values ​​an active lifestyle. It is particularly desirable to have a minimally invasive method, system and device for repairing anatomical joint disorders that specifically targets the subchondral bone in the onset and progression of arthritic disease to alleviate the pain caused by the diseased subchondral bone and the range of symptoms caused by arthritis, including pain, stiffness and swelling. As described herein, it is further desirable to have a method, system, and device for repairing anatomical joints that provides: (1) previously non-existent treatments specifically for bone edema, bone contusions, and osteonecrosis; (2) a structural framework to aid in the repair process of diseased bone adjacent to the joint; (3) enhanced shock absorption of the subchondral bone; (4) enhanced attenuation of compression, tension, and particularly shear stresses of the subchondral bone; (5) a device to prevent further joint deformity from subchondral bone remodeling (such as osteophyte formation); (6) aiding in healing or preventing further destruction of the overlying cartilage by maintaining and allowing vascular and nutrient support from the subchondral bone; (7) aiding in healing or preventing further destruction of the overlying cartilage by providing an adequate structural base; and (8) a minimally invasive alternative to total joint reconstruction that does not preclude joint reconstruction or further joint damage. (10) an implant for arthritis that is less likely to loosen or wear out because it is integral to the trabecular framework on which it is supported; (11) an alternative treatment for tibial patellofemoral and bipolar (tibiofemoral) disease that is relatively easy to perform as an adjunct to arthroscopy and as an outpatient procedure requiring minimal patient operative time; (12) a treatment for arthritis that allows a higher level of activity than is permitted following joint resurfacing or replacement; (13) a low-cost alternative to joint replacement that reduces the need for revisions and surgical morbidity, particularly in countries with limited medical resources; and (14) a treatment option in veterinary medicine, particularly for equine arthrosis and arthritis. Summary of the invention

[0027] According to one embodiment of the present invention, an implantable orthopedic device for repairing an anatomical joint at a treatment site of a human or animal (i.e., a horse, sheep, or cattle) and improving joint conditions includes a first part having a joint-facing end, an opposite mating end, and a side wall extending between the joint-facing end and the mating end. The first part also includes a peripheral column that partially forms the side wall of the first part and a central column that is at least partially within the peripheral column. The joint-facing end includes a plurality of window holes. Each window hole is formed by the confluence of the peripheral column and the central column. The first part also includes a central hole formed in the central column and by the central column and configured to cooperate with the guide. The second part includes a mating end, an opposite front end, and a side wall extending between the mating end and the front end. The side wall has an inner wall and an outer wall. The side wall of the second part includes a protrusion on the inner wall, the outer wall, or a combination of the inner wall and the outer wall. The front end includes an edge that first penetrates the bone during implantation. The side wall of the second part also includes a plurality of window holes between the protrusions. The device has a certain width and length, and the width and length of the device respectively include an aspect ratio between about 0.3 and 3.0. More specifically, the width and length of the device may respectively include an aspect ratio between about 0.3 and 2.0. The implantable orthopedic device is implanted in a bone at a treatment site, and the bone is subchondral bone.

[0028] In some embodiments, the implantable orthopedic device may include a biomaterial. The biomaterial is a biocompatible material, a biocomposite material, a biomimetic material, a bioactive material, a nanomaterial, a partially absorbable material, a fully absorbable material, a tissue forming material, a dual-phase material, a replaceable material, a graft material (e.g., an allogeneic implant, an autologous implant, or a xenograft) or any combination of these materials. The two-phase material may include a solid component and a non-solid component. In some embodiments, the non-solid component is a gel. The gel has elastomeric properties and a viscosity so that it is fully prevented from dripping from the device when the device is implanted in the treatment site. The viscosity is greater than about 1.0 mPa-s (i.e., millipascals). Preferably, the viscosity is between about 1.5 mPa-s and 5.0 mPa-s. For example, the gel generally has a consistency similar to Haribo Gummibarchen (i.e., sticky gummy candy). The non-solid component of the dual-phase material exhibits viscoelastic properties. The biomaterial includes an antimicrobial agent and / or a chemotherapeutic agent.

[0029] In some embodiments, according to some embodiments of the present invention, the anatomical joint may include a mammalian hip joint, knee joint, ankle joint, shoulder joint, elbow joint, wrist joint, finger joint, toe joint or spinal joint. The anatomical joint is selected from the group consisting of acetabular joint, acromioclavicular joint, femoral knee joint, femoral tibial joint, glenohumeral joint, humeroradial joint, humeral joint, interphalangeal joint, metacarpal joint, radioulnar joint and talus tibial joint. In some cases, the anatomical joint is a human knee joint. The disease is selected from the group consisting of chondromalacia patellae, isolated cartilage defect, juvenile idiopathic arthritis, ligament defect arthritis, osteonecrosis, osteoarthritis, osteochondritis dissecans, patellar instability, arthritis after ligament injury, arthritis after meniscectomy, arthritis after meniscectomy, post-traumatic arthritis, suppurative arthritis, rheumatoid arthritis, osteochondral defect, subchondral bone insufficiency, fracture, overload or genetic defect. The term "overload" used herein refers to the pre-fracture state. A plurality of fenestrations (i.e. perforations, openings or pores) have variable sizes (and shapes) that provide support for different tissue types and also promote healing repair at the treatment site. For example, the size of a plurality of fenestrations between the projections on the second portion of the sidewall is between about 300 microns and 1200 microns to promote bone growth, and the size of a plurality of fenestrations on the joint end of the first portion is between about 100 microns to 800 microns to promote cartilage growth. Preferably, the size of a plurality of fenestrations on the joint end of the first portion is between about 400 microns to 800 microns to promote cartilage growth. Consider using circular pores, pie-shaped fenestrations and other shapes. A plurality of fenestrations are pores with a diameter of about 400 microns in order to promote bone growth and pores with a diameter of about 200 microns in order to promote cartilage growth.

[0030] In other embodiments, the outer surface of the device is at least partially textured to increase the surface area of ​​the device. The texture may include a pit pattern or even a relatively more complex "pattern within a pattern" configuration. For example, the outer surface is at least partially coated with a material, which may be a biomaterial that promotes tissue growth, tissue differentiation, and / or tissue attraction. The material coating is selectively applied to create thicker coating areas and thinner coating areas on the outer surface of the device. The material coating may be sprayed on the outer surface of the device, bonded to the outer surface of the device, or deposited on the outer surface of the device. Many ways of coating surfaces are well known to those skilled in the art, and may include, for example, chemical or electrochemical bonding, spraying, vapor deposition, roll-to-roll coating, and many other methods.

[0031] In some embodiments of the present invention, the sidewall of the second part includes one or more vascular grooves extending from the mating end to the front end. One or more vascular grooves provide a surface area for blood adhesion, and can extend in a generally parallel configuration to promote blood flow capillarity and prevent blood flow turbulence. Alternatively or additionally, the one or more vascular grooves can extend in a generally spring-shaped (i.e., coiled) configuration to promote blood flow capillarity and prevent blood flow turbulence. In some embodiments, the device is constructed for custom production, for example, the custom device corresponds to a specific joint anatomical structure to accommodate bipolar defects or gender-specific differences. The device can even be produced, for example, using additive manufacturing (AM), direct metal laser sintering (DMLS), selective laser sintering (SLS), selective laser melting (SLM), metal injection molding (MIM), laser engineering mesh molding (LENS), 3D printing or computer-aided design / computer-aided manufacturing (CAD / CAM) technology. Of course, other production methods can also be considered, without being limited to the examples provided previously. The customized device can be a single device or a modular device, and can be configured to accept and retain a certain amount of biomaterial when the biomaterial is applied after implantation. The amount of biomaterial applied after implantation can be achieved with a needle syringe, a fluoroscope guide or an ultrasound guide. The carrier material can be attached to the device. The carrier material is a polymer, or a biomaterial, or a drug or a mixed combination thereof. The carrier material can be a polymer arranged in a spongy matrix. The carrier material can be a biomaterial including cartilage, osteocartilage, platelet-rich plasma (PRP), a chemotactic substance or a cell differentiation substance. The cartilage or other tissues can be autologous implants, allogeneic implants or xenogeneic implants. For example, the carrier material can also include artificial implants with synthetic materials. The cell differentiation substance can include stem cells, specifically including but not limited to injectable mesenchymal stem cells (MSC) configured to migrate into the device when the device is implanted in the treatment site. In addition, the biomaterial can be contained by the cover.

[0032] In some embodiments, the side wall of the second part has a taper from the mating end to the front end, and the taper has a variable configuration or an adjustable configuration. The outer wall of the side wall of the second part has a taper between about 1.0 and 9.0 degrees from the mating end to the front end, and the inner wall of the side wall of the second part has a taper between about 1.0 and 9.0 degrees from the mating end to the front end. The protrusion on the inner wall and the protrusion on the outer wall are both configured to engage with the bone when the device is implanted in the treatment site. The protrusion can be a thread including a variable pitch design or a consistent pitch design. For example, the thread can be selected from a group consisting of reverse cutting threads, notched threads, tapered threads, support threads, metric threads, trapezoidal threads, mandrel threads, pipe straight threads, unified threads, custom threads, and multiple threads. The tapered thread is configured to continuously exchange new bone to minimize stripping and increase retention at the treatment site.

[0033] In another embodiment, the device also includes at least three pillars, each of which extends between the peripheral pillars and the central pillar and connects the peripheral pillars and the central pillar. Each pillar supports the central pillar. For example, the pillar can be between the pie-shaped windows. Three or more pillars can include one or more flares extending below at least three pillars. The flare is configured to resist the settlement in the bone at the treatment site. It should be understood that at least one flare can be a conical flare, a spiral flare, a notched flare or a barbed flare configuration. The spiral flare can include an angle greater than 45 degrees and the flare is configured to be self-locking. The mating end of the second part includes a non-threaded press-fit portion configured to roughly seal synovial fluid. The device can also include a geometric washer attached to the joint-facing end of the first part. As seen in the cross-sectional side perspective view, the geometry of the washer includes a convex, concave or flat profile. In addition, the geometry of the washer is configured to be bowl-shaped to accommodate biomaterials and promote tissue ingrowth at the treatment site. The biomaterial may comprise a porous material impregnated with a matrix promoting substance, and the substance may support a population of progenitor cells.

[0034] The geometry of the gasket can include a chamber that holds the biomaterial and engages the tissue at the treatment site. The chamber can have an overhanging lip configured to hold the biomaterial. In addition, the geometry of the gasket can be independently customized and configured to match the topography of the bone at the treatment site. This has several advantages, including promoting smooth joint movement after implantation. For example, the attachable gasket includes a threaded attachment, a fork attachment, a sliding locking attachment, a snap attachment, or a notched attachment. After the gasket is attached to the device at the treatment site, the gasket may be partially or completely absorbed over a period of time. The gasket can also be configured to promote guided tissue regeneration (GTR).

[0035] In another embodiment of the present invention, a method for repairing an anatomical joint and improving a joint condition includes providing at least one non-telescopic single-walled main load-bearing strut element with variable geometry and thickness, which has a longitudinal body having open opposite ends and a vertically arranged inner edge and a vertically arranged outer edge suitable for insertion into the subchondral bone. The vertically arranged outer edge is aligned to match the subchondral bone at the treatment site. A plurality of vertically formed hollow grooves are arranged on the outer edge and engaged with a longitudinal insertion retainer. The longitudinal insertion retainer is used to penetrate the subchondral bone during insertion of at least one non-telescopic single-walled main load-bearing strut element into the subchondral bone at the treatment site. By aligning the vertically arranged inner edge to first penetrate the subchondral bone during insertion, at least one non-telescopic single-walled main load-bearing strut element is maintained in an appropriate position within the subchondral bone. The porous portion of the longitudinal body is positioned at the treatment site to promote healing through blood vessels, bridging bones, and other biological elements passing through the porous portion.

[0036] In yet another embodiment, a method for preparing a defect at a treatment site on a subchondral bone to repair an anatomical joint and improve a joint condition includes surgical access to the treatment site. A sizing instrument is introduced, the sizing instrument having a proximal end, a distal end, and a cylindrical member disposed between the proximal end and the distal end. The cylindrical member has an inner cavity for receiving a guide wire. The distal end of the sizing instrument is centrally positioned at an appropriate position above the defect at the treatment site on the subchondral bone. The distal end has concentric rings and each ring has a known diameter. The diameter of the defect is measured by comparing the defect diameter with the closest corresponding known diameter on the sizing instrument. The guide wire is inserted through the inner cavity of the cylindrical member while the distal end of the sizing instrument is centrally positioned above the defect. The subchondral bone is contacted with the distal end of the guide wire. The center of the defect is marked by reversibly attaching the guide wire to the subchondral bone. The sizing instrument is then removed by the guide wire. A countersink instrument having a diameter that roughly matches the measured diameter of the defect is selected. The countersink is located on the guide wire. The countersink is rotated and lowered simultaneously to engage the soft tissue and the subchondral bone. The subchondral bone is penetrated with the countersink to form a hole. The hole has a first depth. The countersink is removed by a guide wire. A cannulated drill is positioned on the guide wire. The inner circular portion of the subchondral bone is now removed while the center post of the subchondral bone is maintained in a substantially undisturbed natural state by simultaneously rotating and lowering the cannulated drill to the center of the countersink. The inner circular portion has a second depth. The cannulated drill is removed by the guide wire. The guide wire is separated from the subchondral bone and the guide wire is removed from the treatment site. An implantable orthopedic device is placed in the hole on top of the center post. When implanted, the center post is received by the hollow center post of the device. The orthopedic device is fixed into the hole using a driving instrument and the driving instrument is removed, thereby fixing the orthopedic device in place. The method may also include the steps of providing an inflatable capsule, inserting the inflatable capsule into the anatomical joint in a collapsed position, and at least partially expanding the capsule to an inflated position to displace surrounding tissue due to expansion pressure. In this way, the surgeon can more easily access and observe the treatment site because as the capsule expands, the tissue near the treatment site retracts (i.e., shifts). The hollow central post of the implantable orthopedic device may include a bevel. When the implantable orthopedic device is placed in the hole on the top of the central post, the bevel narrows the diameter of the hollow central post to compress the central post of the subchondral bone. The bevel includes an angle of approximately 45 degrees. When the central post of the subchondral bone is compressed, the load on the central post increases and / or the resorption of the central post decreases. The bevel prevents the formation of bone cysts and / or bone spurs. The implantable orthopedic device includes a blind-ended central hole that only partially extends through the joint-facing end of the device so that synovial fluid (i.e., synovial fluid) leakage is reduced or even prevented.

[0037] The first depth as previously described allows the implantable orthopedic device to be implanted approximately flush with (or slightly below) the surface of the subchondral bone. The second depth promotes blood flow around the top and sides of the center post to facilitate repair of the anatomical joint at the treatment site. The center post of the subchondral bone is maintained in a substantially undisturbed state to provide structural integrity to the treatment site and facilitate repair of the anatomical joint. The diameter of the inner portion is less than or equal to the diameter of the countersunk hole, and the diameter of the inner portion is greater than the diameter of the wall of the implantable orthopedic device. The inner portion has a second depth sufficient to allow placement of the implantable orthopedic device.

[0038] In addition, the countersink instrument includes two or more blades and the blades are equidistantly spaced from each other. The blades are arranged circumferentially around the central axis. In some embodiments, the countersink instrument includes four blades, each blade being oriented at 180 degrees relative to an adjacent blade. The hollow drill includes two or more forks, and each fork is equidistantly spaced from each other. In other embodiments, the hollow drill includes three forks, and the forks are configured to remove and sweep away bones during use to maintain the porosity of the bones, minimize tissue damage, stimulate bleeding and promote healing at the treatment site. Each blade is configured to have a radius of curvature that roughly reflects the radius of curvature of the subchondral bone at the treatment site. The radius of curvature of the subchondral bone at the treatment site can be convex, concave or even flat (i.e., 180 degrees).

[0039] A small amount of bleeding during this operation is beneficial to promote healing. Bleeding includes laminar blood flow, turbulent blood flow, capillary blood flow and osmotic blood flow. Using a drive instrument to fix the orthopedic device in the hole also includes engaging the distal end of the drive instrument with the joint-facing end of the first part of the orthopedic device and screwing the orthopedic device into the hole. The method may also include creating one or more vascular channels in the subchondral bone at the treatment site to facilitate additional small bleeding. These vascular channels are created after the step of removing the countersunk hole by the guide wire. For example, the vascular channel is created by drilling, reaming, tapping, boring or piercing. Of course, other methods can also be considered to create vascular channels and microchannels.

[0040] The second depth is greater than the length of the implantable orthopedic device. The distal end of the driving instrument reversibly engages the joint-facing end of the device to move the orthopedic device into the hole. The step of moving the orthopedic device into the hole can also include locking the device at such a depth in the hole that the joint-facing end of the device is roughly flush with the surface of the subchondral bone at this depth. The orthopedic device is locked via a Morse locking tapered connector. The treatment site can be entered from various directions using different surgical techniques. For example, the site can be entered from below through the engagement surface using an antegrade insertion technique. The treatment site can also be entered from either side using a peripheral insertion technique. Alternatively, the treatment site can be surgically entered using a retrograde insertion technique, thereby entering the treatment site or joint compartment in the direction opposite to the antegrade direction. For example, retrograde, antegrade and peripheral insertion techniques are well known to those of ordinary skill in the art including orthopedic surgeons. The implantable orthopedic device can be covered with a protective sleeve before the device is introduced into the patient's body, and the sleeve can be removed before the device is positioned in the hole on the top of the center column.

[0041] In another embodiment of the present invention, a cannula is disclosed for arthroscopically retracting target tissue at an anatomical joint. The cannula includes a delivery tube having a distal end, a proximal end, and an elongated member disposed between the distal end and the proximal end. A guide slot extends at least partially along the length of the elongated member. A rod-shaped retractor is configured to be movably inserted into the delivery tube. The retractor has a distal end, a proximal end, and an elongated portion disposed between the distal end and the proximal end. The distal end of the retractor is bent at an angle relative to the elongated portion of the retractor. In use, the distal end of the retractor is configured to movably follow the slot and engage the target tissue. When a force is applied to the proximal end of the retractor, the engaged tissue is retracted in a generally proximal direction relative to the axis of the delivery tube. The retractor can be locked in place along the slot. The cannula can have an angle of about 90 degrees. For example, the delivery tube of the cannula can be made of a transparent material such as a transparent plastic. The cannula can be configured to extend telescopically and can be non-straight. The cannula is capable of maintaining a reversible customized configuration. The customized configuration is achieved by applying one or more directional forces (e.g., bending the shape memory material) along the delivery tube. The retractor may include an inflatable balloon that expands around at least a portion of the cross-sectional perimeter of the cannula. The cannula also includes one or more modular blades. The cannula is bendable to facilitate navigation along a curved anatomical path.

[0042] In yet another embodiment, a method for retracting anatomical joint tissue is disclosed. The joint has a target space, and the method includes surgically accessing the anatomical joint. An inflatable capsule is arthroscopically inserted into the target space in a first collapsed position, and the inflatable capsule is at least partially expanded to a second inflated position to displace surrounding tissue due to the inflation pressure. The capsule is filled with a gas or a liquid. If the capsule is inflated with a liquid, a saline solution may be used. Of course, many other substances may be used to safely and effectively inflate the capsule.

[0043] In other embodiments, the anatomical joint is a human knee joint and the target space is a suprapatellar notch or a retropatellar notch. For example, the displaced tissue may be cartilage, ligament, tendon, and / or adipose tissue. The inflatable envelope is collapsible in a collapsed position and may also be deflated and subsequently removed from the target space.

[0044] In another embodiment, a method for delivering at least one therapeutic biomaterial to a primary treatment site to repair an anatomical joint includes delivering an implantable orthopedic device. The device includes a plurality of portions, each portion having a different surface area. A first biomaterial is applied to at least a first portion of the orthopedic device, and the device is implanted at the primary treatment site, where the biomaterial promotes repair of the anatomical joint. A portion of the biomaterial may migrate from the primary treatment site to a surrounding joint compartment to provide treatment to a secondary site beyond the primary treatment site. For example, the secondary site may be a medullary canal. A second biomaterial is applied to at least a second portion of the device. The second biomaterial and at least the second portion are different from the first biomaterial and at least the first portion of the device. The at least one therapeutic biomaterial may be a biocompatible material, a biocomposite material, a biomimetic material, a bioactive material, a nanomaterial, a partially absorbable material, a fully absorbable material, a tissue forming material, a biphasic material, a replaceable material, a graft material (e.g., an allogeneic implant, an autologous implant, or a xenograft) or any combination of the foregoing materials. After the orthopedic device is implanted at the treatment site, at least one therapeutic biomaterial is applied to at least a first portion of the device. At least one therapeutic biomaterial is applied to at least a first portion of the device before and after the orthopedic device is implanted in the treatment site. Furthermore, the at least one therapeutic biomaterial promotes tissue growth, stimulates bleeding, and prevents infection, thereby facilitating repair of the anatomical joint. The at least one therapeutic biomaterial also possesses chemotaxis, cell homing, biological crosstalk, and / or time release capabilities. In some embodiments, at least the first and / or at least the second portion of the device comprises pores, a scaffold, a lattice, a matrix, or any combination thereof, and different surface areas of each portion correspond to properties of the at least one biomaterial.

[0045] In another embodiment of the present invention, a kit for repairing an anatomical joint is disclosed. The kit includes an implantable orthopedic device, a sizing instrument, a guide wire, a countersink instrument, a core drill, a drill guide, a drill bit, a sleeve, a driver instrument, a syringe, an inflatable capsule, at least one biomaterial, instructions for use, and packaging. The packaging retains the implantable orthopedic device, sizing instrument, guide wire, countersink instrument, core drill, drill guide, drill bit, sleeve, driver instrument, syringe, inflatable capsule, at least one biomaterial, and instructions for use of the kit as described above. In some embodiments, the kit is sterilizable.

[0046] In another embodiment of the present invention, a method for fixing a carrier material to a bone defect includes positioning a first implantable orthopedic device approximately near the bone defect. The device includes a joint-facing end, an opposite mating end, and a sidewall extending between the joint-facing end and the mating end. The sidewall includes a fenestration. A section of strand material is provided, the strand having a first and a second end. The first end passes through the first fenestration. The first end exits through the second fenestration. The first end is then fixed to the device. The first carrier material is placed approximately near or in contact with the joint-facing end of the device. The carrier material has therapeutic properties. The second end of the strand material is looped around the carrier material. The second end passes through a third fenestration opposite or adjacent to the first fenestration. The second end exits through a fourth fenestration. The second end of the section of strand material is stretched across the carrier material and the second end is fixed to the device so that the carrier material is tied near the joint-facing end of the device. For example, the first end and the second end can be fixed to the device by tying a knot at each end. The strand material can include an absorbable suture or a non-absorbable suture, and the carrier material and / or one or more strands can be fixed before or after the device is implanted. Additional lengths of strand material are used to form a pattern to secure the carrier material near the joint-facing end of the device.

[0047] In yet another embodiment of the present invention, a method of attaching a carrier material to a bone defect includes positioning a first implantable orthopedic device approximately near the bone defect at a first location. A second implantable orthopedic device is positioned approximately near the bone defect at a second location. It should be noted that the first and second locations are different locations. Each of the first and second devices includes a joint-facing end, an opposing mating end, and a sidewall extending between the joint-facing end and the mating end. The carrier material is placed approximately adjacent to or in direct contact with the joint-facing ends of the first and second devices. The carrier material spans a continuous area between the first and second devices across the bone defect. A section of strand material is provided, and the material has a first end and a second end. The first end passes through a first fenestration in the first device. The first end exits through a second fenestration in the first device. The first end is secured to the first device. The second end of the strand material is looped around the carrier material. The second end passes through a first fenestration in the second device. The second end exits through a second fenestration in the second device. The second end of the section of suture material is stretched across the carrier material. The second end is secured to the second device so as to tie the carrier material between the devices. The sidewall may include threads for anchoring the device in bone, and if the sidewall includes threads, the threads include notches spaced apart along the thread path. The fenestrations are vertically aligned below each notch. The carrier material comprises a polymer or a biomaterial or a drug or a combination thereof. The fenestrations may be vertically aligned with each other along the sidewall.

[0048] In another embodiment, a drive instrument for reversibly engaging an implantable orthopedic device is disclosed. The device is configured to be implanted in a bone. The drive instrument includes a distal end having a convex configuration, the convex configuration including a centrally located threaded protrusion and a relatively short, elongated knob. The knob forms a diameter around the protrusion so that when the drive instrument approaches the implantable device and is rotated, the threaded protrusion engages a mirrored, reversed concave configuration located on the joint-facing end of the implantable device. Continued rotation causes the knob to engage a corresponding configuration on the implantable device to provide sufficient leverage to implant the implantable orthopedic device into the bone.

[0049] In yet another embodiment, a removal tool for removing an implantable orthopedic device implanted in a bone is disclosed. The removal tool includes a distal end, a proximal end, and an elongated member disposed between the distal end and the proximal end. The elongated member includes a catheter extending at least along the length of the distal end. The catheter includes two or more bumps protruding from the inner surface of the catheter. The bumps are configured to engage and slide over corresponding notches spaced vertically along the threaded path of the implantable orthopedic device when the removal tool is placed above the exposed surface of the implantable orthopedic device. After the two or more bumps engage and slide over at least one corresponding notch, the removal tool is rotated so that the notch is positioned between the threaded paths. This allows an effective lever to remove the device from the bone using twisting and / or pulling. The bumps on the inner surface of the catheter are approximately 0.9 mm long. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] These and other features, aspects and advantages of the present invention will become better understood with reference to the following description, appended claims and accompanying drawings, in which:

[0051] 1A, 1B and 1C are side views of embodiments of an apparatus for repairing anatomical joint conditions according to the present invention;

[0052] Figure 1D is a side perspective view of an embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0053] Figure 2A , 2B , 2C and 2D are top perspective views of other embodiments of devices for repairing anatomical joint disorders according to the present invention;

[0054] Figure 3 is an exploded top side perspective view of an embodiment of an apparatus for repairing the anatomical joint condition shown in FIG. 1A ;

[0055] Figure 4A , 4B , 4C and 4D are top perspective views of embodiments of devices for repairing the anatomical joint conditions shown in FIGS. 1A , 1B, 1C and 1D , respectively;

[0056] Figure 5 is a bottom perspective view of an embodiment of a device for repairing the anatomical joint condition shown in FIG. 1A ;

[0057] Figure 6 It is used for repair Figure 2A A top perspective view of an embodiment of a device for anatomical joint disorders is shown;

[0058] Figure 7 and 8 is a top perspective view of an embodiment of a device for repairing an anatomical joint condition;

[0059] Fig.9A is a cross-sectional side view of an embodiment of a device for repairing the anatomical joint condition shown in FIG. 1A , taken along line 9 - 9 ;

[0060] Fig. 9B It was intercepted along Route 9-9 for restoration Figure 1B A cross-sectional side view of an embodiment of a device for anatomical joint disorders shown in;

[0061] Fig. 9C It was taken along line 9-9 for repair Figure 1C A cross-sectional side view of an embodiment of a device for anatomical joint conditions is shown;

[0062] Fig.9D is a cross-sectional side view of another embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0063] Fig.10 is a cross-sectional side view of another embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0064] Fig.11A is a side view of an embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0065] Figures 11B-11D is a side perspective view of an alternative embodiment according to the present invention;

[0066] Fig.11E is a side perspective view of an embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0067] Fig.11F is a top view of another embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0068] Fig.11G is a side perspective view of another embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0069] Figure 11Ha-11Hc is a side perspective view of an alternative embodiment according to the present invention;

[0070] Figure 11Hd-11Hi According to an alternative embodiment of the present invention Figure 4D A top view of

[0071] Figure 11Hj-11Hl According to an alternative embodiment of the present invention Figure 4D A top view of

[0072] Figure 11Hm is a side perspective view of an alternative embodiment according to the present invention;

[0073] Figures 12A-12B is a side view of an embodiment of the present invention;

[0074] Figures 13A-13B is a top perspective view according to an embodiment of the present invention;

[0075] Figures 13C-13D is a side perspective view of yet another embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0076] Fig.14A is a top perspective view of an embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0077] Fig. 14B is a side view of an embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0078] Fig.15A is a flow chart of an embodiment of a method for repairing an anatomical joint condition according to the present invention;

[0079] Fig. 15B is a cross-sectional view depicting an embodiment of a method for repairing an anatomical joint condition according to the present invention;

[0080] Figures 16A to 16V is a schematic diagram of some steps of a method for repairing an anatomical joint disorder according to the present invention;

[0081] 17A to 17C is a cross-sectional view showing an embodiment of a device for repairing an anatomical joint condition according to the present invention;

[0082] Figures 17D-17E is a side perspective view of another embodiment of the present invention;

[0083] Figure 17Fa is a cross-sectional view of the distal end of a cannula according to other embodiments of the present invention;

[0084] Figure 17Fb-17G is a side perspective view of another embodiment of the present invention;

[0085] Fig.17H A sleeve including teeth is shown;

[0086] Fig.18A is a side perspective view of one embodiment of the present invention;

[0087] Figures 18B-18D is a top perspective view of an embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0088] Fig.19Ais a side perspective view of a human knee joint illustrating an embodiment of the present invention;

[0089] Figures 19B-19C is a perspective view of an embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0090] Figures 20A-20B and 20D is a perspective view of a countersink instrument according to another embodiment of an apparatus for repairing an anatomical joint condition of the present invention;

[0091] Fig. 20C yes Figures 20A-20B and a bottom perspective view of the countersink instrument shown in 20D;

[0092] Fig.20E is used Figures 20A-20D A perspective view of a countersunk hole prepared in a bone by an instrument in FIG.

[0093] Fig.20F is used Figures 20A-20D Cross section of a countersunk hole prepared in a bone by an instrument in;

[0094] Fig.21A is a perspective view of an embodiment of a cannulated drill for repairing anatomical joint conditions according to the present invention;

[0095] Fig. 21B is a perspective view of another embodiment of a cannulated drill as another embodiment of an apparatus for repairing an anatomical joint condition according to the present invention;

[0096] Fig. 21C is a perspective view of yet another embodiment of a cannulated drill for repairing anatomical joint conditions according to the present invention;

[0097] Fig.21D is used Figures 21A-21C A perspective view of a hole and post made in a bone using an instrument implemented in FIG.

[0098] Fig.21E is used Figures 21A-21C Cross-section of a hole and post prepared in a bone using an instrument implemented in;

[0099] Fig.22A and 22B is a perspective view of a protective cover for covering an implantable orthopedic device according to an embodiment of the present invention;

[0100] Figures 23A-23C is a perspective sequence diagram of a drive apparatus and an implantable orthopedic device according to an embodiment of the present invention;

[0101] Fig.24A is a diametrical side view of an extraction tool engaged with an implantable orthopedic device according to an embodiment of the present invention;

[0102] Fig. 24B is a perspective view of a retrieval tool and an implantable orthopedic device according to an embodiment of the present invention;

[0103] Fig.24C is according to an embodiment of the present invention after the removal tool is further engaged with the implantable orthopedic device Fig. 24B Side view of

[0104] Figures 25A-25B are sequential perspective views of a retrieval tool and an implantable orthopedic device according to an embodiment of the present invention;

[0105] Fig.26 is a radial perspective view from within the extraction tool as it is placed over an exposed surface of an implantable orthopedic device according to an embodiment of the present invention. DETAILED DESCRIPTION

[0106] According to one embodiment of the present invention, a device for repairing anatomical joint conditions and improving joint conditions is provided. According to another embodiment of the present invention, a method for repairing anatomical joints and improving joint conditions is provided, whereby a defect is prepared at a treatment site on a bone to repair an anatomical joint, a sleeve for retracting target tissue; a method for delivering at least one biomaterial to a primary treatment site; and a kit for repairing an anatomical joint. In one embodiment, the method includes providing a device according to the present invention. These embodiments will now be described in detail.

[0107] As used in this disclosure, the term "comprise" and variations of the term such as "comprising", "containing" and "with" are not intended to exclude other additives, components, integers or steps, unless the context requires otherwise.

[0108] As used in this disclosure, unless the context requires otherwise, the method steps disclosed and illustrated are neither limiting nor intended to indicate that each step is essential to the method or that each step must occur in the sequence disclosed, but are merely exemplary steps.

[0109] All dimensions specified in this disclosure are by way of example only and are not intended to be limiting unless the context otherwise requires. In addition, the proportions shown in these drawings are not necessarily to scale. As will be understood by those skilled in the art from this disclosure, the actual size and proportion of any device or portion of a device disclosed in this disclosure will be determined by its intended use.

[0110] This provisional application is related to U.S. patent application serial number 13 / 421,792 (the applicant's own reference number is 96342-893565-000120US) entitled "Method and Device for Ameliorating Joint Conditions mid Diseases" filed on March 15, 2012, which has now been granted U.S. Patent No. 8,968,404, the contents of which are incorporated by reference in their entirety into this disclosure. This provisional application is also related to U.S. patent application serial number 13 / 420,825 (the applicant's own reference number is 96342-894576-000110US) entitled "Joint Support and Subchondral Support System" filed on March 15, 2013, which has now been granted U.S. Patent No. 8,753,401, the contents of which are incorporated by reference in their entirety into this disclosure.

[0111] According to one embodiment of the present invention, methods, systems and devices for repairing anatomical joint conditions are provided. As shown in Figures 1A, 2A and 3, the device 10 includes a first portion 12 and a second portion 14, and includes a generally cylindrical shape that is partially or completely closed at one end. The first portion 12 and the second portion 14 can be attached separately (i.e., threaded or press-fit) or fused together. The device 10 also includes an axial length (aa). The axial length (aa) is between about 5 mm and 30 mm (Figure 1A). The device can be as shown in Figures 1A, 2A and 3. Figure 1B , 1C Or a single part as shown in 1D. The axial length (aa) can be between 8mm and 16mm. Preferably, the axial length (aa) is 8mm ( Fig. 9B ) or 14mm( Fig. 9C ).

[0112] The first portion 12 of the device 10 includes a joint-facing end 16, an opposite mating end 18, and a sidewall 20 extending between the joint-facing end 16 and the mating end 18. The first portion 12 also includes a diameter (dd) and an axial length (bb). The diameter (dd) is between 5 mm and 30 mm ( Figure 4A In another embodiment, the diameter (dd) is between 6 mm ( Figure 4B ) and 16mm( Figure 4C ). In one embodiment, the device may be tapered so that the diameter (dd) is different from the diameter (dd'). For example, Fig. 9B and 9CTapers of 6 mm and 16 mm (dd) to 5 mm and 14 mm (dd') are shown, respectively. In one embodiment, the axial length (bb) is between 0.5 mm and 2.5 mm (FIG. 1A). Preferably, the axial length (bb) is between about 1 mm and 2.5 mm. The axial length (bb) to the beginning of the first thread 46 is shown as the distance (ee). For example, the distance (ee) is about 2.45 mm ( Fig. 9B ) and about 4mm( Fig. 9C ).

[0113] In one embodiment, the first portion 12 further includes a peripheral column 22 that partially forms the side wall 20, a central column 24, and three or more struts 26, each strut 26 extending between and connecting the peripheral column 22 and the central column 24, and each strut 26 thereby supporting the central column 24.

[0114] In one embodiment, the joint-facing end 16 further includes a plurality of windows 28, wherein each window 28 is formed by the confluence of the peripheral pillars 22, the central pillar 24, and two adjacent pillars 26 of the three or more pillars 26. As will be understood by those skilled in the art from this disclosure, each window 28 may include any shape suitable for the intended purpose of the device 10. In one embodiment, as Figure 2A and 4A As particularly shown in FIG. 1 , each window 28 comprises a pear or teardrop shape. In another embodiment, as shown in FIG. Figure 2B , 2C , 2D, 4B, 4C and 4D, each window 28 comprises a circular aperture. As will be appreciated by those skilled in the art based on this disclosure, all of the window apertures 28 on the device 10 may comprise the same size and shape, or one or more of the window apertures 28 may comprise different sizes, different shapes, or both, while one or more other window apertures 28 are different. The windows may also be arranged as follows: Figure 7 and 8 "Pattern 701, 801 within pattern 702, 802" is shown. This arrangement may also include irregular and / or wavy surface geometries. Of course, other patterns are possible.

[0115] The fenestrations may have different porosities to promote specific tissue growth and differentiation. For example, fenestrations of about 300-1200 microns in diameter may promote existing bone growth and / or regenerate bone (particularly along the sides of the device), while fenestrations of about 400-800 microns may be best suited for promoting existing cartilage growth, regenerating cartilage, and / or preventing bone hypertrophy at the treatment site to promote healing (particularly at the joint-facing end of the device). Additional information on preventing bone hypertrophy is described in U.S. Patent Application Serial No. 15 / 148,894 filed on May 6, 2016 (now published as U.S. Patent Application Publication No. 2016 / 0250026A1), which is incorporated herein by reference.

[0116] The first portion 12 or joint-facing end of the device also includes a central hole 30 formed within and by the central post 24. For example, in particular Fig.9A As shown, the central hole 30 may extend completely axially through the joint-facing end 16, or may be blind-ended and extend partially through the interior of the joint-facing end 16, such as Fig.9D As shown. The central hole 30 is configured to cooperate with a driving instrument as disclosed and described below. As will be understood by those skilled in the art based on this disclosure, the central hole 30 includes any shape suitable for the intended purpose of the device 10. For example, the central hole 30 can be square, circular ( Figure 2A and Figure 6 ), Hexagram( Figure 2B , 2C , 2D, 3, 5), Pentagram( Figure 7 ) or a pentagon ( Figure 8 In one embodiment, Figure 2A As shown in FIG. 23 , the central hole 30 includes threads 32 to assist in mating with a driving instrument.

[0117] exist Fig.9D In another embodiment shown in a cross-sectional side view of FIG. 1 , the hollow center post 1120 of the implantable orthopedic device 10 can include a bevel 1119. The bevel is essentially a symmetrical inclined surface at the edge or corner 1118. When the implantable orthopedic device 10 is placed in the hole above the top of the center post 1513, the bevel 1119 reduces the diameter of the hollow center post 1120 from a diameter dd' to a diameter dd" to compress the center post 1513 (e.g., the subchondral bone 1514) against the subchondral bone 1514. Fig. 15B As shown). For example, the bevel 1119 at the corner 1118 may include an angle of about 45 degrees. When the center pile of the subchondral bone is compressed, the load of the center pile 1513 is increased and / or the resorption of the center pile is reduced. In addition, especially when the bevel is in contact with the washer 1111 ( Figures 11A-11E ) or lid 1142( Fig.11G) are used in combination to reconstruct the interval and form a barrier to seal the compartment of the device 10, the bevel 1119 prevents the formation of bone cysts and / or bone spurs. The implantable orthopedic device 10 may include a blind-ended central hole 30 that only partially extends through the joint-facing end 16 of the device 10 so as to reduce, prevent or prevent synovial fluid (i.e., synovial fluid) leakage. Since the primary function of synovial fluid is to reduce friction between the articular cartilage of the joint during movement, it is important to contain synovial fluid in the joint cavity. Another advantage of this embodiment is that it easily allows backfilling during OATS (i.e., osteochondral autologous implant transfer system) when healthy cartilage from a non-load-bearing joint is transferred to a damaged area of ​​the knee joint or other anatomical joint.

[0118] In one embodiment, the peripheral pillar 22 of the first portion 12 includes one or more notches 34, such as Figure 2A and Figure 6 As will be understood by those skilled in the art from this disclosure, in addition to or in lieu of the central hole 30, a recess may also be used to mate with a driver.

[0119] As will be appreciated by those skilled in the art from this disclosure, the joint-facing end 16 of the first portion 12 of the device 10 performs a partial load bearing and / or load sharing function after implantation and includes a shape adapted to substantially match the shape of the articular surface that the device 10 reconstructs on the bone after implantation. Figures 9A-9C The concave profile seen in the cross-sectional side view shown in Fig.10 The joint-facing end may have a convex profile as seen in the side view shown in FIG. 1 , or even a neat profile. The joint-facing end may have a convex profile with a radius of curvature between about 10 mm and 50 mm. In one embodiment, the washer may be attached to the joint-facing end of the first portion and have a convex profile as seen in the cross-sectional transverse perspective view ( Figures 11A-11F ) as seen in the concave, convex, or flat profile.

[0120] As will be appreciated by those skilled in the art from this disclosure, the sidewall 20 of the first portion 12 may have any shape suitable for the intended purpose of the device 10. In a preferred embodiment, Fig.9A As shown, the sidewall 20 of the first portion 12 includes a generally convex profile as seen in the cross-sectional side perspective view. As will be appreciated by those skilled in the art based on this disclosure, the convex profile is beneficial for providing a smooth transition to the surrounding cartilage and bone after implantation and promoting biological integration.

[0121] The device 10 also includes a second portion 14. The second portion 14 of the device 10 includes a mating end 36, an opposite front end 38, and a sidewall 40 extending between the mating end 36 and the front end 38. The second portion 14 also includes an axial length (cc). The axial length (cc) can be between about 5 mm and 30 mm (FIG. 1A). For example, preferably, the axial length (cc) is between about 6 mm ( Fig. 9B ) and about 11mm( Fig. 9C ). In one embodiment, as seen in FIGS. 1A and 9A , the sidewall 40 of the second portion 14 is substantially cylindrical. In another embodiment, as seen in FIGS. Fig. 9B As shown, the side wall 40 of the second portion 14 is generally conical and tapers between the mating end 36 and the front end 38. In one embodiment, the side wall 40 of the second portion 14 tapers between about 0.2 degrees and 15 degrees, and preferably, the side wall 40 of the second portion 14 tapers about 9 degrees ( Fig. 9B ).

[0122] The mating end 36 of the second portion 14 of the device 10 is configured to mate with the mating end 18 of the first portion 12 of the device 10. As will be appreciated by those skilled in the art in light of this disclosure, the mating end 18 of the first portion 12 and the mating end 36 of the second portion 14 may include any mating mechanism suitable for the intended purpose for which the device 10 may be used. In one embodiment, as will be appreciated by those skilled in the art in light of this disclosure, the mating end 18 of the first portion 12 and the mating end 36 of the second portion 14 are mated by a suitable biocompatible adhesive. In a preferred embodiment, as will be appreciated by those skilled in the art in light of this disclosure, the mating mechanism is reversible, allowing alternating first portions 12 to be interchanged to a particular second portion 14, such that the device 10 may be reconfigured as needed to conform to the contours of a particular engagement surface, thereby reducing the number of second portions 14 that need to be stored in the field. In one embodiment, as will be appreciated by those skilled in the art in light of this disclosure, the mating end 18 of the first portion 12 and the mating end 36 of the second portion 14 are mated by a reversible twist lock mechanism. In another embodiment, the first portion 12 and the second portion 14 are made such that Figure 9B-9C The shown unified whole is inseparable.

[0123] The first portion 12 and the second portion 14 may include any material suitable for the intended purpose of the device 10, as will be understood by those skilled in the art based on the present disclosure. The first portion 12 may include a material selected from the group consisting of biocompatible plastics, biocomposite polymers, metals, and metal alloys or a material selected from the group consisting of carbon fiber, cobalt-chromium alloy, nitinol (e.g., nitinol), polycaprolactone (PCL), polyetheretherketone (PEEK), tantalum, and titanium. In one embodiment, the second portion 14 includes a material selected from the group consisting of biocompatible plastics, biocomposite polymers, metals, and metal alloys. The second portion 14 includes a material selected from the group consisting of carbon fiber, cobalt-chromium alloy, nitinol, polycaprolactone (PCL), polyetheretherketone (PEEK), tantalum, and titanium. The first portion 12 may include a first material and the second portion 14 may include a second material, wherein the first material and the second material are the same material or different materials.

[0124] As will be appreciated by those skilled in the art from this disclosure, the device 10 can be made by any suitable method. In one embodiment, as will be appreciated by those skilled in the art from this disclosure, the first portion 12 and the second portion 14 are made of modular components, such as by additive manufacturing (AM), direct metal laser sintering (DMLS), selective laser sintering (SLS), selective laser melting (SLM), metal injection molding (MIM), laser engineered mesh shaping (LENS), 3D printing, 3D bioprinting (i.e., printing using biological tissue), computer-aided design / computer-aided manufacturing (CAD / CAM). Alternatively, the device 10 can be made as a single-piece device. For example, the device 10 can be produced in a customized manner to correspond to a specific joint anatomy, including bipolar and / or gender-specific differences.

[0125] The front end 38 of the second portion 14 of the device 10 is configured to place the device 10 into a prepared space made according to the method of the present invention. In one embodiment, the front end 38 includes a scalloped edge 42. In another embodiment, the front end 38 includes a beveled edge 44. For example, Figure 1Aa , 1D , 2A, 2D and 3, the front end 38 may include both the scalloped edge 42 and the beveled edge 44. In one embodiment, the front end 38 includes, for example, Figure 1B , 1C and the beveled edge 44 shown in 9D. Alternatively, the leading edge 38 may not include a beveled edge ( Fig. 1Ab In yet another embodiment, for example, the scalloped edge 42 may have a shape of the letter "V" rotated 180 degrees ( Fig. 1Ab and 2A ) or the shape of the letter "U" rotated 180 degrees ( Figure 2DIn some embodiments, the scalloped edges may be relatively pronounced (i.e., similar to table legs) to reduce material costs and lower the overall profile of the implant ( Fig. 1Ab The implant may include threads 46 along the side wall 40 or lack threads 46, respectively. Figure 1Aa and Fig. 1Ab Thread shown.

[0126] The sidewall 40 of the second portion 14 of the device 10 extends between the mating end 36 and the front end 38. The sidewall 40 of the second portion 14 includes threads 46 for anchoring the device 10 in the bone. In one embodiment, the sidewall 40 of the second portion 14 also includes a plurality of fenestrations 48 (FIGS. 1A, 1B, 1C, and 1D) between the threads 46. In a preferred embodiment, the device 10 also includes a plurality of fenestrations 50 (FIG. 1A) formed by the confluence of the mating end 18 of the first portion 12 and the mating end 36 of the second portion 14. Each fenestration 48, 50 may include any size or shape suitable for the intended purpose of the device 10, including but not limited to providing support for different tissue types to promote healing and repair at the treatment site. In a preferred embodiment, the fenestration may be oval, circular, or other shapes. In one embodiment, as will be understood by those skilled in the art based on the present disclosure, the sidewall 40 of the second portion 14 is textured to promote bone ingrowth after implantation. The fenestrations between the protrusions on the second portion of the side wall are sized between about 300 microns and 1200 microns to promote bone growth, while the plurality of fenestrations on the joint-facing end of the first portion are sized between about 400 microns and 800 microns to promote cartilage growth. The fenestrations may be in the form of pores, each pore having a diameter of about 800 microns to promote bone growth. Pores having a diameter of about 500 microns may be most suitable for promoting cartilage growth. The outer surface of the device is at least partially textured to increase the surface area of ​​the device. For example, the texture may include a pattern of dimples or even Figure 7 The “pattern 701 within pattern 702” configuration shown in FIG. Figure 8 Another variation of this "pattern 801 within pattern 802" configuration is depicted in . Of course, many other such patterns can be envisioned, and the invention is not limited to the explicit examples provided here.

[0127] like Figure 1D and 4D As shown, especially in Figure 2DIn the embodiment, a plurality of windows 48a, 48b are located between threads 46a, the threads 46a including at least some windows 48b positioned vertically aligned with notches 46b. The notches are positioned along (i.e. following) the helical thread path. The notches 46b are intermittently spaced along the thread path and intermittently interrupt the thread path. In this embodiment, one end of a suture or similar material can be passed through the windows 48b on one side of the device 10 and secured in place at each securing point with a knot, clip or other fastener. The other end of the suture can be wrapped around the joint-facing end 16 and passed through (i.e. inserted into) the windows 46b on the other side of the device 10 to hold the biomaterial roughly in place on the top of the joint-facing end 16 of the device. The following is based on Figure 11Ha-11Hi The discussion of details explains this particular embodiment.

[0128] refer to Fig.10 , the joint-facing end 16 may be concave. Figures 11B-11D As shown, washers 1111, 1121, 1131 can be attached to the joint-facing end of the device via threads 1141, pins 1151, or snap-fits 1161, respectively. These threads may include reverse-cut threads, notched threads, tapered threads, support threads, metric threads, trapezoidal threads, push-rod threads, pipe straight threads, unified threads, custom threads, and multiple threads. The washers can have geometric surfaces that are convex 1611, concave 1612, or flat 1613. For example, the washers 1111 can also slide in direction 1181 so that the tracks 1171 meet and engage corresponding grooves 1191 of the device 10 to secure the washers 1111 together, as shown. Fig.11E shown. Fig.11F 1 is a top view of the joint-facing end of the device 10, which shows a chamber 1201 that can contain a carrier substance 1211 (such as a polymer, or a biomaterial, or a drug, or a mixed combination thereof). For example, the biomaterial can include cartilage, osteocartilage, a chemotactic substance, or a cell differentiation substance (including stem cells). For example, the drug can include an antimicrobial agent, an antibiotic, an antiviral agent, or a chemotherapeutic agent. The therapeutic biomaterial can possess chemotaxis, cell homing, biological crosstalk, and / or time release capabilities and promote tissue growth, stimulate bleeding, and prevent infection to promote repair of anatomical joints.

[0129] Fig.11G Another embodiment is depicted in which a cover 1142 may be secured to the joint-facing end 16 of the device 10 via a snap-fit ​​arrangement 1145. A male portion 1143 of the cover 1142 engages a female portion 1144 of the joint-facing end 16 of the device 10. The cover 1142 may contain a carrier substance 1146 comprising a polymer or a biomaterial or a hybrid combination thereof.

[0130] As sequence Figure 11Ha-11HcAs shown, the carrier material 1147 can be located roughly above the joint-facing end 16 of the device 10 (e.g., on top thereof) and fixed in place using one or more strands 1148a, 1148b, 1148c, 1148d, 1148e. The strands can include suture materials including absorbable sutures (e.g., polylactic acid, poliglecaprone, polydioxanone) and non-absorbable sutures (e.g., nylon, polyester, silk, polypropylene) and elastic bands, laces, fine lines, tethers or similar materials. The strands can be roughly circular, oval or flat in cross-sectional area and can be combined with or impregnated with therapeutic agents. The strands can additionally include a metal hoop 1152a at one or both ends of the strand 1152b to facilitate passing the strand 1148c through the window hole 48b. After passing the strand end 1152a through the window hole 48b, the end can be attached by a knot 1150 or other fixing mechanical device. The opposite end 1152b (i.e., the non-fixed end) of the strand 1148c is looped across the carrier material 1147, and the end 1152b passes through the window hole relative to (or adjacent to) the window hole 48b and is anchored in place using a knot or other fastener to firmly tighten the strand with sufficient tensile strength throughout the joint-facing end 16 to keep the carrier material 1147 in place. The carrier material and / or one or more strands can be fixed before or after the device 10 is implanted in the bone. For example, if one or more strands are attached in a constructed pattern before positioning the carrier material 1147, the strand with some elastic properties can preferably allow lifting (i.e., stretching upward away from the joint-facing end 16 of the device) to create enough space to allow the carrier material to be rolled into the appropriate position below the strand. Sliding self-locking sutures can also be used.

[0131] If the strands are to be secured after implantation, at least one layer of fenestrations will need to be accessed to secure the strands. When the implant is secured approximately flush with the joint, exposure of at least one row of fenestrations and the notched strands may be accomplished by clearing tissue around the periphery of the implanted device using a reamer or other instrument. In one embodiment of the invention, indicator marks 156 may be included on the top surface of the device facing the joint end 16 to aid in visually locating the notches and fenestrations when the device is implanted approximately flush with the bone surface. Figure 4DAn example of an indicator mark 156 is shown in , where the indicator mark is an engraved "N". The strands can also be fixed when only part of the device is implanted, and the device can be subsequently implanted roughly flush after the strands have been attached. In this way, it is possible to minimize or avoid removing tissue around the periphery of the device to enter the window. The notch 46b between the threads 46a serves as a guide for the strands comprising the sutures, and keeps them in place to prevent them from migrating (i.e. rolling, sliding) to the right or left side of the window to which they are attached. The notch 46b in this particular embodiment also prevents the sutures from crossing and spanning the sharp strands. In this way, for example, the notch reduces the risk of the strands becoming weak (e.g., wearing or cutting off).

[0132] like Figure 11Hm As shown, the carrier substance 1147 can be preloaded on the device 10. The term "preloaded" refers to an embodiment in which the carrier substance 1147 is attached to the device 10 before the device is partially or completely implanted in the treatment site (i.e., a bone defect). One advantage of preloading the carrier substance is that time is saved during surgery. In this embodiment, the carrier substance 1147 is attached to the edge of the joint-facing end 16 of the device. The attachment can be made with one or more strands or other attachment means. In this way, for example, the carrier substance 1147 can be regarded as a "top flap". The strand 1148a is loosely attached to the other side (or multiple sides) of the device in a certain slack state, so that the carrier substance 1147 can be positioned off-center relative to the center hole 30. This makes the center hole 30 accessible to the driving instrument. After the device has been implanted at the treatment site and the driving instrument has been removed, the carrier substance 1147 is roughly tightened above the joint-facing end 16 of the device 10 (e.g., on top of it) by pulling the loosely attached strands to remove the slack state. The strands can then be secured in place with knots, sliding self-locking sutures, or other attachment means 1150. The strands can include suture materials including absorbable sutures (e.g., polylactic acid, poliglecaprone, polydioxanone) and non-absorbable sutures (e.g., nylon, polyester, silk, polypropylene) and elastic bands, ties, strings, tethers, or similar materials. The strands can be generally circular, oval, or flat in cross-sectional area and can be bonded to or impregnated with a therapeutic agent.

[0133] Figure 11Ha-11Hc The strand configuration shown includes a total of 5 individual strands positioned in an "asterisk" pattern ( Figure 11Hc ). However, a variety of other patterns are contemplated based on various factors and considerations. For example, these considerations may include, but are not limited to, the thickness of the carrier material, the composition of the strand material, the area of ​​the bone defect proximal to the joint-facing end of the device, and the surgeon's preference. Most of these considerations are specific to each repair and the associated anatomy. Figure 4DSeveral examples of suture patterns for six-point suture attachment are shown in the top view of FIG. 114 after the carrier material 1147 has been positioned, including a "hexagonal" ( Figure 11Hd ), "letter H" ( Figure 11He ), "Single Strand" ( Figure 11Hf ), "Geometric spring pad" ( Figure 11Hg ), "Disordered Network" ( Figure 11Hh ) and "letter X" ( Figure 11Hi ). In this embodiment, the carrier material is attached to the device without disturbing the surrounding cartilage.

[0134] For example, you can Figure 11Hh More than a single suture may be woven, stitched, or otherwise positioned in the same direction across the same area, as shown by sutures 1148b, 1148b' in FIG. 1 . In this particular example, the pattern provides additional strength on the left side to hold the carrier material 1147 in place. It is also contemplated that several embodiments may be combined to secure the carrier material in place. For example, Fig.11G The snap-fit ​​cover shown can be Figure 11Ha-11Hi The embodiment shown is additionally sutured.

[0135] In addition to suturing the carrier material to the implant, the carrier material can be bonded to the implant or coated on the implant using an adhesive. For example, a coating such as this can include hydroxyapatite (HA). Regardless of how the carrier material is attached to the implant, the carrier material can be fixed to the implant before or after implantation of the device 10 into the bone.

[0136] It should be understood that a variety of stitches and suture puncture patterns may be used to secure a carrier material containing a polymer, or a biomaterial, or a drug, or a combination thereof, to an implantable orthopedic device according to the methods and devices described herein. In addition, suture securement is not limited to six-point securement attachment, and sutures attached at three rather than six points of securement may be used for attachment, e.g., Figures 11Hj to 11Hl These variations, as well as variations in the design of the above-described devices and apparatuses, are within the scope of the present disclosure.

[0137] Now turn to Fig. 12A , the device 10 can be securely attached to the bone using the flare 1299. The flare 1299 can be used alone or in combination with the threads 46. In addition, the flare can be located on the outside of the device 1299 or on the inside of the device 1298 ( Fig. 12B ) or a combination thereof. The bell mouths 1298, 1299 can also be used in conjunction with the threads 46 to securely fix the device 10 to the bone.

[0138] One or more vascular channels may be created in the subchondral bone at the treatment site to facilitate beneficial bleeding. For example, these vascular channels 1511, 1512 may be located at the Fig. 15B . The vascular access is created by drilling, reaming, tapping, opening or poking into the bone. It has been found that some minor bleeding actually promotes healing as the blood relies on the capillaries to move upward toward the treatment site. In this regard, Fig.13A and 13B is the internal part of the device 10 ( Fig.13A ) or external ( Fig. 13B ) to allow blood to be carried by capillaries. Fig. 13C As seen in FIG. 1 , the channels can be arranged in a vertical configuration 1313 on the device, with each channel being approximately parallel to the adjacent channels. A spiral configuration 1314 ( Fig.13D ) and many other channel configurations.

[0139] According to one embodiment of the present invention, the anatomical joint condition is repaired by removing an inner circular portion of the subchondral bone to create the space 116 while using a cannulated drill or other similar orthopedic instrument to maintain the central post 1413 of the subchondral bone in a substantially undisturbed natural state. Fig.14A It is a top view of the central pile 1413 and the surrounding bones 1414. Fig. 14B Roughly Fig.14A , showing the center post 1413 and the space 116. After the space 116 is created, a vascular channel can be made in a relatively deep vertical direction 1412 and / or in an oblique direction 1411 to induce bleeding. See also Fig. 15B Channels 1511 and 1512 in.

[0140] Fig.15A15 is a flow chart outlining the steps for repairing an anatomical joint condition using the present invention. The surgeon begins the procedure (step 1515) by surgically accessing the treatment site (step 1516). Optionally, an inflatable capsule and / or sleeve may be positioned to retract tissue for better access to the treatment site (step 1517). A sizing instrument is centrally positioned over the defect at the treatment site on the subchondral bone (step 1518). The diameter of the defect is measured with concentric rings on the sizing instrument by comparing the defect diameter to the closest corresponding known diameter on the sizing instrument (step 1519). A guide wire is inserted through the lumen of the cylindrical member with the distal end of the sizing instrument centrally positioned over the defect (step 1520). The subchondral bone is contacted with the distal end of the guide wire and the center of the defect is marked by reversibly attaching the guide wire to the subchondral bone (step 1521). Next, the sizing instrument is removed by the guide wire (step 1522). A countersink instrument having a diameter that substantially matches the measured diameter of the defect is selected (step 1523). A countersink instrument is positioned over the guide wire (step 1524). The thickness of the countersink mimics the thickness of the joint-facing end of the implant. The subchondral bone is penetrated with the countersink to form a hole having a first depth by simultaneously rotating and lowering the countersink to engage the soft tissue and subchondral bone (step 1525). The first depth is checked (step 1526). If the hole is too shallow to place the device at the desired depth (step 1527), step 1525 is repeated. If the desired depth is acceptable (i.e., the device is flush with the bone surface, sunk slightly below the bone surface, or protrudes slightly above the bone surface, respectively, as shown in FIG. 1524 ), the countersink is placed in the subchondral bone. Figure 16Ta-16Tc), the first depth may be deemed acceptable (step 1528) and the countersunk hole may be removed over the guide wire (step 1529). A cannulated drill is positioned over the guide wire (step 1530). An inner circular portion of the subchondral bone is removed (step 1531) while the center pile of the subchondral bone is maintained in a substantially undisturbed natural state by simultaneously rotating the cannulated drill and lowering the cannulated drill into the center of the countersunk hole. The inner circular portion has a second depth that is checked (step 1532). If the second depth is too shallow, step 1531 may be repeated. If the second depth is found to be slightly deeper than the length of the device (step 1534), the cannulated drill may be removed over the guide wire (step 1535). At this stage, one or more vascular channels may be created in the subchondral bone (step 1536). Next, a protective sleeve is optionally placed over the implantable orthopedic device (step 1537), and the device is implanted in the patient. The device is positioned in the hole on top of the center pile, and the sleeve is removed (step 1538). When positioned / implanted, the central bone post is received by the hollow central column of the device. The orthopedic device is secured into the hole using a driver instrument (step 1539), and the driver instrument is removed. The guide wire is separated from the subchondral bone (step 1540), and the guide wire is removed. At the end of the revision surgery (step 1542), the treatment site is closed (step 1541).

[0141] Fig. 15B 1 is a cross-section of an embodiment of the present invention for repairing an anatomical joint. For the purpose of the following description, bone 1514 will refer to the subchondral bone at the knee joint. However, the following description can be used for any bone that requires anatomical joint repair. The subchondral bone 1514 surface 104 has been prepared at the defect site by penetrating the bone to a first depth gg with a countersink instrument and removing the inner circular portion of the bone to a second depth hh using a cannulated drill, while keeping the central pile 1513 of the subchondral bone substantially intact and substantially undisturbed. By removing the inner circular portion of the bone, a circular space 116 is created. The central pile 1513 is retained because very little bone is removed to provide structural integrity to the treatment site and facilitate repair. The second depth hh promotes blood flow 124 around the wall of the central pile 1513. Vascular channels 1511, 1512 can be created at various angles and depths to enter the vascular system (i.e., the capillary bottom layer) 1510 to promote bleeding 124. For example, bleeding can include laminar blood flow, turbulent blood flow, capillary blood flow, and osmotic blood flow.

[0142] As shown in direction 1515, the implantable orthopedic device 10 is placed on top of the post 1513. The width dd of the device 10 can be slightly wider than the width ff of the post 1513. The length aa of the device 10 can be slightly less than or equal to the second depth hh to allow adequate placement of the device 10. The center post 1513 receives the hollow center post of the device 10. When the device 10 is fully implanted, the joint-facing end 1516 of the device 10 is approximately flush with the surface 104 of the subchondral bone 1514 via the countersunk hole (e.g., the first depth gg allows the device 10 to be placed in an orientation that is approximately flush with the bone surface 104). In some cases, such as Figure 16Tb As shown, the joint-facing end 1516 of the device 10 can be implanted below the surface 104 of the subchondral bone 1514 to account for the thickness of the carrier material that can be optionally attached to the joint-facing end of the device before or after implantation. The diameter of the inner circular portion of the removed bone (i.e., space 116) is less than or equal to the diameter of the countersunk hole.

[0143] According to another embodiment of the present invention, a method for repairing an anatomical joint condition or disease in a patient is provided. Figures 16A to 16L , wherein a schematic diagram of some steps of a method for repairing an anatomical joint and improving joint conditions and diseases and preparing a defect at a treatment site on subchondral bone to repair an anatomical joint according to the present invention is shown. In this example, the accompanying drawings show an embodiment of a method used on a femoral tibial joint 100 to improve arthritis symptoms that have caused a defect 102 on an articular surface 104 of a bone or joint (here shown as on the medial condyle 106 of a femur 108).

[0144] First identify that the patient suffers from a joint disorder or disease suitable for the treatment of the method, wherein the joint includes a bone having a surface comprising a defect caused by the joint disorder or disease. Diagnosing a patient can include performing one or more actions, including performing a physical examination, performing non-invasive imaging examinations (such as magnetic resonance imaging, computed tomography and ultrasound), performing arthroscopy or simply consulting patient records to determine whether the patient suffers from a joint disorder or disease suitable for treatment by the method. As those skilled in the art will understand according to the disclosure, the joint can be any joint with a hyaline cartilage bearing surface, a joint capsule and synovial fluid. The joint can be a wrist joint (i.e. a synovial joint). In one embodiment, the joint is selected from the group consisting of acetabular joint, acromioclavicular joint, femoral knee joint, femoral tibial joint, glenohumeral joint, humeroradial joint, humeral joint, interphalangeal joint, metacarpal joint, radioulnar joint and ankle joint. In one embodiment, the patient can be a human or non-human animal. In a preferred embodiment, joint diseases and conditions are selected from the group consisting of arthrosis, chondromalacia patellae, isolated cartilage defects, juvenile idiopathic arthritis, ligamentous defective arthritis, osteoarthritis (degenerative arthritis or degenerative joint disease), osteonecrosis, osteochondritis dissection, patellar instability, arthritis after ligament injury, arthritis after meniscectomy, arthropathy after meniscectomy, post-traumatic arthritis, septic arthritis, rheumatoid arthritis and genetic defects. In one embodiment, identifying a patient includes diagnosing a patient suffering from joint disorders and diseases.

[0145] The method also includes accessing the joint treatment site 100 via arthroscopy or by open surgery (eg, mini-open surgery).

[0146] like Fig. 16B and 16C As shown, the bone surface 104 includes an abnormality (i.e., defect) 110 (e.g., an area of ​​softened, thinned, damaged, or missing cartilage), and a burr and / or suction device 112 can be used to remove some or all of the abnormality 110, thereby creating a smoother joint surface 104, such as Fig. 16C shown.

[0147] like Fig.16D As shown, the distal end of a sizing instrument 1909 is placed over the defect 102 to measure the defect using concentric rings 1902a, 1902b on the sizing instrument by comparing the diameter of the defect 102 to the closest corresponding known ring diameter 1902a, 1902b on the sizing instrument 1909.

[0148] The method also includes inserting a guide wire 114 through the lumen 1903 of the size measuring instrument 1909 when the size measuring instrument is positioned over the center of the defect 102. The distal end of the guide wire 114 contacts the bone and is reversibly attached to the bone to mark the center of the defect 102. Fig.16E As shown, the sizing instrument 1909 is removed over the guide wire 114 while the guide wire 114 remains attached to the bone.

[0149] The countersink instrument 2601 is positioned over the guide wire 114 and moved to contact the defect 102 ( Fig.16F ).like Figure 16G As shown, the countersink instrument 2601 is rotated 2602 to displace soft tissue and some bone to a given depth. When sufficient depth has been determined, the countersink is removed via a guide wire.

[0150] Next, the method further includes creating a space 116 in the bone defect 102 of the device. In one embodiment, as Fig.16H and Fig.16I As shown, a core drill 118 placed over a guide wire 114 is used to create a space 116 to de-cored and planarize the surface of the defect 102. The core drill 118 is then removed, leaving the guide wire 114 in place.

[0151] In one embodiment, the method further includes using a drill guide 120 ( Fig.16J ) and the drill bit 122 ( Figure 16K ) to create one or more vascular channels deep within the bone of space 116. For example, Figure 16L As shown, creation of the one or more vascular channels is confirmed by the presence of blood 124 leaking from the one or more vascular channels into space 116. Drill guide 120 and drill bit 122 are then removed, leaving guide wire 114 in place.

[0152] Next, the method also includes providing a first device 126 for repairing a joint condition suitable for improving a joint condition or disease in a patient, such as can be Figure 16M As seen, the device comprises a sterilizable kit containing packaging 1601, instructions 1602, and other instruments and materials for repairing joint conditions as described herein. In one embodiment, the first device 126 is a device according to the present invention. The first device 126 is provided having dimensions suitable for incorporation into the space 116 made in the defect 102, and the joint-facing end of the first device 126 comprises a shape suitable for substantially matching the shape of the joint surface 104 that the first device 126 regenerates on the bone after implantation, as will be understood by those skilled in the art from this disclosure. Reference is now made to Fig.16N , for example, by mating the distal end of the driver 128 with the central hole of the first device 126, the first device 126 is attached to the driver 128. Figures 22A-22BIn one embodiment shown, the method further optionally includes covering the device 126 with a sleeve 155 prior to positioning the device 126 within the patient. The sleeve 155 protects the surrounding tissue as the device 126 is moved through the tissue and ultimately positioned within the space 116 created in the defect 102. Immediately prior to placing the device 126 at the site of the defect 102 (e.g., prior to positioning the orthopedic implant in the hole on top of the center post), the sleeve 155 is removed. The sleeve 155 may be made of a transparent or translucent material to facilitate visual orientation of the device and removal of the sleeve over the defect 102.

[0153] In one embodiment, Fig.16O As shown, the method further includes injecting a biomaterial 130, such as a biomaterial (i.e., stem cells or platelet-rich plasma, or both stem cells and platelet-rich plasma), into the first device 126 using a syringe 132. In one embodiment, the method further includes placing an insert according to the present invention into the first device 126 instead of injecting a biocompatible bone cement into the first device 126. In one embodiment, the insert is a biomaterial according to the present invention.

[0154] The method also includes screwing the first device 126 into the space 116 using the driver 128, such as Figures 16P to 16S shown. Figure 16Ta-16Tc FIG. 1 is a partial transverse cross-section of the medial condyle 106 at the site of the defect 102, showing the placement of the first device 126. As can be seen in FIG. Figure 16Ta As seen in FIG. 1 , the joint-facing end of the first device 126 is formed into a shape that roughly recreates the shape of the normal joint surface on the bone after implantation. In this example, the device is implanted roughly flush with the bone surface. This is beneficial for load sharing. Figure 16Tb Alternatively, the device 126 is shown sunk slightly below the bone surface with a carrier substance 1147 attached to the joint-facing end to promote tissue ingrowth, bone integration, and healing. Figure 16Tc Alternatively, the device 126 is shown protruding slightly above the bone surface. This facilitates weight bearing.

[0155] In one embodiment, as can be Figure 16Ua As seen in FIG. 1 , the method further includes placing one or more additional devices 134, 136 in the defect 102. In one embodiment, the one or more additional devices are one additional device. In another embodiment, the one or more additional devices are two additional devices. As will be understood by those skilled in the art based on this disclosure, the one or more additional devices 134, 136 may be the same size and shape as the first device, or may be different size and shape from the first device.

[0156] In another embodiment, a carrier material comprising a polymer or a biomaterial or a hybrid combination thereof may be secured within and / or between more than one implantable orthopedic device. Figure 16Ub yes Figure 16Ua , showing devices 126, 134, 136 and defect 102. For example, devices 126, 134, 136 may be Figure 11Ha-11Hc Same or different sized versions of the device 10 are implemented. As previously mentioned, the carrier substance 1147 can be fixed to the joint-facing end of each device before or after implantation. Figure 16Ub A carrier substance 1147 is shown secured in each of three differently sized devices. Figure 16Uc A carrier substance 1147 is shown spanning the area between devices 126 and 136 attached (e.g., tied) with suture strands 1148a, 1148b. In this example, the suture strands are shared by devices 126, 136 to secure the carrier substance 1147 in place over the defect 102 generally between devices 126, 136. A second carrier substance is secured to device 134, respectively. In the example shown in FIG. Figure 16Ud In another configuration pattern shown, the carrier material 1147 is secured between the devices 126, 134, 136 with sutures to cover a majority of the defect 102. In yet another embodiment, Figure 16Ue A carrier substance 1147 is shown secured between the devices 126, 134, 136 with a strand 1148a shared between the devices.

[0157] There are many combinations of suture puncture patterns, anchor types and sizes, anchor placement locations, and deployment sequences that can be used to attach a carrier material to and / or between more than one implantable device according to the methods and devices described herein. The carrier material may include a mesh, substrate, gasket, or recessed configuration and may be attached to the thread (eg, a suture, a staple, a coating, an adhesive, or a similar attachment) prior to or after implantation of the device into the bone. Figure 1Aa )、Pressing( Fig. 12A ) or smooth ( Fig. 1Ab ) implantable orthopedic devices. These variations, as well as variations in the design of the above-described devices and apparatuses, fall within the scope of the present disclosure.

[0158] Although the method of the present invention has been disclosed with respect to a defect 102 in a femoro-tibial joint 100, a corresponding method may be used for other joints. Figure 16V is a partial transverse cross-sectional view of the glenohumeral joint 138 at the defect site illustrating the placement of the device 126 for repairing a joint condition in accordance with the present invention.

[0159] 17A to 17CA cannula 1701a for arthroscopically retracting target tissue at an anatomical joint is shown. The cannula 1701a includes a delivery tube 1702 having a distal end 1704, a proximal end 1705, and an elongated member disposed between the distal and proximal ends. A guide slot 1703 extends at least partially along the length of the elongated member, and a rod-shaped retractor 1706B is configured to be movably inserted 1707 into the delivery tube along the slot 1703. The retractor has a distal end 1709, a proximal end 1708, and an elongated portion disposed between the distal and proximal ends. Fig. 17B and 17C As shown, the distal end 1709 of the retractor can be bent at an angle 1710 between about 1 degree and 179 degrees relative to the elongated portion. When the cannula is used to retract target tissue at an anatomical joint, the distal end of the retractor is configured to movably follow the narrow slot 1703 and engage and retract the target tissue in a generally proximal direction relative to the axis of the delivery tube when a force 1712 is applied to the proximal end of the retractor. The distal end 1709 can be rotated about the axis 1713 to help engage the target tissue. The delivery tube 1702 of the cannula 1701a can be bendable to conform to a variety of shapes, including as Fig.17D The curved shape shown Fig.17E The S-shape shown or any other shape that facilitates engagement and retraction of target tissue within the sometimes tortuous path within the anatomical joint space. The bendable configuration can be reversibly customized via application of one or more directional forces along the delivery tube 1702 .

[0160] exist Figure 17Fa , 17Fb 17 and 17G show cannulas 1701b, 1701c having a "half-tube" design feature. When viewed in cross-section, the distal tip 1716 of the cannula is shaped like the letter "C" ( Figure 17Fa For example, the sleeve 1701b may be Figure 17Fb The sleeve 1701c may be a transparent material (e.g., transparent plastic) as shown, or the sleeve 1701c may be an opaque material (e.g., Figure 17G The shape of the cannula facilitates visualization of the implant as it is delivered to the defect. Openings 1714, 1715 may also be used for this purpose. The half-tube feature may include extending only a few millimeters from the tip 1717 or substantially along the entire length 1718 of the cannula 1701b. Fig.17H As shown, cannula 1701d may also include teeth 1716a to hold the cannula in place as the implant is delivered to the target tissue site. Cannula 1701a, 1701b, 1701c may be used with or without a guide wire.

[0161] Fig.18A1802 includes an inflatable retractor preferably located near the distal end 1804, which can be respectively located in a cross-section ( Fig.18D , 18C 18B ) is expanded around some 1806, most 1805, or all 1803 of the sleeve 1802. As the retractor expands, target tissue is moved away from the defect 102 to allow for enhanced access and visualization of the defect during anatomical joint repair.

[0162] Fig.19A 1 is a side perspective view of a human knee joint, which illustrates an embodiment of the present invention. As shown, an inflatable capsule 1901 has been inserted into a target space in an arthroscopic manner. In this example, the target space includes a suprapatellar depression 1902 between a femur 108 and a quadriceps femoris 1903 near a human knee joint. Of course, for example, the capsule 1901 can be inserted into any number of positions included between the femur 108 and the patella 1904. When the capsule expands, it will replace tissue by expansion pressure, thereby better approaching and observing defects. For example, the capsule can be expanded by gas or liquid (i.e., saline solution).

[0163] Fig.19B The envelope is shown in a deflated state prior to insertion. Fig.19C The envelope is shown expanded by the introduction of gas or liquid through nozzle 1905. The envelope can be configured to expand in a number of directions 1906, 1907, 1908. It is generally preferred to have the envelope expand primarily in direction 1906 for use as a "joint jack" type (e.g. similar to a car jack that lifts a car to help change a flat tire).

[0164] Figures 20A-20B 20D is a perspective view of a countersink instrument 2601 of another embodiment of an apparatus for repairing anatomical joint disorders according to the present invention. Lumen 2001 is provided for inserting a guide wire 114 when in use. Countersink instrument 2610 may include two or more blades equally spaced from each other. Figures 20A-20D A total of 4 blades 2602, 2603, 2604, 2605 are shown. Fig. 20C Shown in Figures 20A-20B and a bottom perspective view of the countersink instrument shown in 20D. Fig.20E is used Figures 20A-20D A perspective view of a countersink 2606 prepared in a bone 104 by the countersink instrument 2601 in FIG. Fig.20F is used Figures 20A-20D The instrument 2601 is shown in cross-section with a countersunk hole 2606 prepared in a bone 104. The countersunk hole instrument 2601 is used to substantially clear soft tissue and to drill a countersunk hole in a bone prior to using a cannulated drill.

[0165] Now turn to Fig.21A , the hollow drill 118a includes two forks (i.e. blades) 2101 and 2102 that are equally spaced from each other. Fig. 21C As shown, the core drill 118c may have four prongs 2106, 2107, 2108, 2109. However, Fig. 21B The three pronged 2103, 2104, 2105 cannulated drill 118b shown in FIG. 1 is preferred because, for example, it is more likely to drill a true hole without jamming bone into the area 2110 between the prongs. The cannulated drills 118a, 118b, 118c remove bone 104 while leaving a central core 1513 of intact bone beneath the countersunk hole 2606. This is useful in the case of a conventional drill having a plurality of prongs 2103, 2104, 2105, and 2106. Figures 21A-21C Perspective view of the device in Fig.21D ) and cross-sectional view ( Fig.21E ) is shown in. For example, the countersink instrument 2601 and / or the core drills 118a, 118b, 118c can be made of stainless steel, titanium, or other materials known in the art.

[0166] Fig.23A 1 is a perspective view of a drive instrument 157 reversibly engaging an implantable orthopedic device 10. The device is configured to be implanted in a bone 102. The drive instrument 157 includes a distal end 158 having a male configuration including a centrally located threaded projection 159 and relatively short elongated knobs 160a, 160b, 160c. The knobs are formed with a diameter around the projection 159. When the drive instrument 157 is aligned 161 about the implantable device 10, lowered 166 into position, and rotated 162 in one direction, the threaded projection 159 engages a mirrored reversed concave configuration 163 located on the joint-facing end 164 of the implantable device 10. As shown in FIG. Fig. 23B As shown, continued rotation 162 causes the knobs 160a, 160b, 160c to engage corresponding recessed features 165a, 165b, 165c on the implantable device to provide sufficient leverage to implant the implantable orthopedic device 10 into the bone 102. Fig.23C As shown, rotating the drive instrument in the opposite direction 168 allows the knobs 160a, 160b and 160c and the threaded protrusion 159 to disengage from the now implanted device 10 and remove the drive instrument 157 from the area 169.

[0167] Now go to Fig.24A, which shows a removal tool 171 in a cross-sectional view. The removal tool can be used to remove the orthopedic device 10 implanted in the bone 102. The removal tool 171 includes a distal end 172, a proximal end 173, and a slender member 174 arranged between the distal end and the proximal end. The slender member 174 includes a catheter 175 extending at least along the length of the distal end 172. The catheter 175 includes two or more bumps 176a, 176b. The length of each bump is between about 0.5 and 1.5 mm. Preferably, the length of each bump is about 0.9 mm. The bumps 176a, 176b protrude from the inner surface 177 of the catheter 175. As shown in FIG. Fig. 24B and 25A -25B, the projections are configured to engage and slide through 178 corresponding notches 46b spaced vertically along the path of the thread 46a of the implantable orthopedic device 10, so that when the extraction tool 171 is placed on the exposed surface 180 (e.g., a surface not implanted in the bone) of the implantable orthopedic device 10 and two or more projections 176a, 176b engage 181 and slide 178 through the corresponding notches, the extraction tool 171 is rotated in either direction 179 to place the notches between the thread paths. Once placed in place, the extraction tool allows effective leverage when twisting and / or pulling to remove the device from the bone when used. Once the device is removed from the bone, the extraction tool can be separated from the orthopedic device by rotating the extraction tool relative to the orthopedic device to release the projection between the thread paths and then aligning the projection with the notch. Once the projection is aligned with the notch, the extraction tool can be separated from the device by guiding the projection along the vertically aligned notch in a direction away from the orthopedic device. In this way, the extraction tool and the orthopedic device can be separated.

[0168] Although the present invention has been discussed in considerable detail with reference to certain preferred embodiments, other embodiments are possible. Therefore, the scope of the appended claims should not be limited to the description of the preferred embodiments contained in this disclosure.

Claims

1. An implantable orthopedic device for repairing an anatomical joint at a treatment site of a human or animal and improving a joint condition, the implantable orthopedic device comprising: a) a first portion comprising a joint-facing end, an opposite mating end, and a sidewall extending between the joint-facing end and the mating end; wherein the joint-facing end includes a plurality of first window holes; and wherein the first portion further comprises a central hole configured to cooperate with the introducer; and b) a second portion comprising a mating end, an opposite front end, and a side wall extending between the mating end and the front end, the side wall having an inner wall and an outer wall, wherein the side wall of the second portion includes a protrusion on an inner wall, an outer wall, or a combination thereof; wherein the leading end comprises an edge that first penetrates bone during implantation; and wherein the side wall of the second portion further comprises a plurality of second window holes between the protrusions, wherein the implantable orthopedic device has a width and a length, wherein the width and length of the implantable orthopedic device each comprise an aspect ratio between approximately 0.3 and 3.0; and Wherein, the side wall of the second part includes one or more vascular grooves extending from the mating end to the front end, and the one or more vascular grooves provide a surface area for blood adhesion to promote capillary flow of blood toward the joint-facing end and the treatment site.

2. The implantable orthopedic device of claim 1, wherein: The one or more vascular grooves provide surface area for blood to adhere to promote capillary flow of blood toward the joint-facing end and the treatment site.

3. An implantable orthopedic device according to claim 1 or 2, wherein: The one or more vascular grooves extend in a generally parallel configuration to promote blood flow capillarity and prevent blood flow turbulence; or The one or more vascular grooves extend in a generally spring-shaped configuration to promote blood flow capillarity and prevent blood flow turbulence.

4. An implantable orthopedic device for repairing an anatomical joint at a treatment site of a human or animal and improving a joint condition, the implantable orthopedic device comprising: a) a first portion comprising a joint-facing end, an opposite mating end, and a sidewall extending between the joint-facing end and the mating end; wherein the joint-facing end includes a plurality of first window holes; and wherein the first portion further comprises a central hole configured to cooperate with the introducer; and b) a second portion comprising a mating end, an opposite front end, and a side wall extending between the mating end and the front end, the side wall having an inner wall and an outer wall, wherein the side wall of the second portion includes a protrusion on an inner wall, an outer wall, or a combination thereof; wherein the leading end comprises an edge that first penetrates bone during implantation; and wherein the side wall of the second portion further comprises a plurality of second window holes between the protrusions, wherein the implantable orthopedic device has a width and a length, wherein the width and length of the implantable orthopedic device each comprise an aspect ratio between approximately 0.3 and 3.0; wherein the protrusion of the sidewall of the second portion comprises notched threads for anchoring the implantable orthopedic device in bone; and wherein the notches of the threads are spaced apart along a thread path.

5. An implantable orthopedic device for repairing an anatomical joint at a treatment site of a human or animal and improving a joint condition, the implantable orthopedic device comprising: a) a first portion comprising a joint-facing end, an opposite mating end, and a sidewall extending between the joint-facing end and the mating end; wherein the joint-facing end includes a plurality of first window holes; and wherein the first portion further comprises a central hole configured to cooperate with the introducer; and b) a second portion comprising a mating end, an opposite front end, and a side wall extending between the mating end and the front end, the side wall having an inner wall and an outer wall, wherein the side wall of the second portion includes a protrusion on an inner wall, an outer wall, or a combination thereof; wherein the leading end comprises an edge that first penetrates bone during implantation; and wherein the side wall of the second portion further comprises a plurality of second window holes between the protrusions, wherein the implantable orthopedic device has a width and a length, wherein the width and length of the implantable orthopedic device each comprise an aspect ratio between approximately 0.3 and 3.0; Wherein, the implantable orthopedic device comprises a biomaterial.

6. The implantable orthopedic device of claim 5, wherein the biomaterial is a biocompatible material, a biocomposite material, a biomimetic material, a bioactive material, a nanomaterial, a partially absorbable material, a fully absorbable material, a tissue forming material, a biphasic material, a replaceable material, a graft material, or any combination of the foregoing.

7. An implantable orthopedic device according to claim 5 or 6, wherein the biomaterial comprises a dual-phase material, the dual-phase material comprising a solid component and a non-solid component, and wherein the non-solid component is a gel, the gel having elastomeric properties and a viscosity so as to substantially prevent the gel from dripping from the implantable orthopedic device when the implantable orthopedic device is implanted at the treatment site.

8. The implantable orthopedic device of claim 7, wherein: The implantable orthopedic device comprises at least one of the following features: The viscosity is greater than about 1.0 mPa-s; The viscosity is between about 1.5 mPa-s and 5.0 mPa-s; or The non-solid component of the dual phase material exhibits viscoelastic properties.

9. An implantable orthopedic device according to claim 5, 6, 7 or 8, wherein: (i) the biological material comprises an antimicrobial agent and / or a chemotherapeutic agent, or (ii) the biological material is contained by the cover; or (iii) the implantable orthopedic device is configured to receive and retain a quantity of the biomaterial when the biomaterial is administered after or before implantation of the implantable orthopedic device; (iv) a carrier substance is attached to the implantable orthopedic device, the carrier substance being a biological material including cartilage, osteochondral, platelet-rich plasma, a chemotactic substance, or a cell differentiation substance; or (v) wherein a carrier material is attached to the implantable orthopedic device, the carrier material being a polymer, a polymer in a sponge-like matrix arrangement, or a biomaterial or a drug or a combination thereof; or (vi) wherein the biomaterial comprises a porous material impregnated with a matrix promoting substance, the substance supporting a population of progenitor cells.

10. The implantable orthopedic device of claim 9, wherein (iii) the implantable orthopedic device is configured to receive and retain a certain amount of the biomaterial when the biomaterial is applied after or before implantation of the implantable orthopedic device, and in, The amount is administered after implantation via a needle syringe, fluoroscopic guide, or ultrasound guide.

11. The implantable orthopedic device of claim 9, wherein (iv) a carrier substance is attached to the implantable orthopedic device, the carrier substance being a biological material comprising cartilage, osteochondral, platelet-rich plasma, a chemotactic substance, or a cell differentiation substance; and in, The cell differentiation material includes stem cells or injectable mesenchymal stem cells configured to migrate to the implantable orthopedic device when the implantable orthopedic device is implanted at the treatment site.

12. An implantable orthopedic device for repairing an anatomical joint at a treatment site of a human or animal and improving a joint condition, the implantable orthopedic device comprising: a) a first portion comprising a joint-facing end, an opposite mating end, and a sidewall extending between the joint-facing end and the mating end; wherein the joint-facing end includes a plurality of first window holes; and wherein the first portion further comprises a central hole configured to cooperate with the introducer; and b) a second portion comprising a mating end, an opposite front end, and a side wall extending between the mating end and the front end, the side wall having an inner wall and an outer wall, wherein the side wall of the second portion includes a protrusion on an inner wall, an outer wall, or a combination thereof; wherein the leading end comprises an edge that first penetrates bone during implantation; and wherein the side wall of the second portion further comprises a plurality of second window holes between the protrusions, wherein the implantable orthopedic device has a width and a length, wherein the width and length of the implantable orthopedic device each comprise an aspect ratio between approximately 0.3 and 3.0; Therein, a carrier substance is attached to the joint-facing end of the implantable orthopedic device, the carrier substance having therapeutic properties.

13. The implantable orthopedic device of claim 12, wherein the carrier substance is configured to be fixable to the implantable orthopedic device before or after implantation of the implantable orthopedic device.

14. The implantable orthopedic device of claim 12 or 13, further comprising a length of strand material having a first end and a second end; in, the first end being secured to the implantable orthopedic device; wherein the first portion of the strand material is arranged to be threaded through a first window aperture and a second window aperture, wherein the first window aperture and the second window aperture are vertically aligned with each other; wherein the second portion of the strand material is arranged to form a loop around the carrier material; wherein the third portion of the strand material is arranged to be threaded through a third window aperture and a fourth window aperture, the third window aperture being opposite or adjacent to the first window aperture; wherein the third window and the fourth window hole are vertically aligned with each other; and wherein the second end is secured to the implantable orthopedic device so as to tether the carrier material proximate the joint-facing end of the implantable orthopedic device.

15. An implantable orthopedic device according to claim 12, 13 or 14, wherein: (i) the carrier material is a polymer; or (ii) the carrier material is a polymer, a biomaterial, a drug or a combination thereof arranged in a sponge-like matrix; (iii) The carrier substance is a biological material including cartilage, osteochondrium, platelet-rich plasma, chemotactic substances or cell differentiation substances.

16. The implantable orthopedic device of claim 15, wherein (iii) the carrier substance comprises a biomaterial of cartilage, osteochondral, platelet-rich plasma, a chemotactic substance, or a cell differentiation substance, and in, The cell differentiation material includes stem cells or injectable mesenchymal stem cells (MSCs) configured to migrate to the implantable orthopedic device when the implantable orthopedic device is implanted at the treatment site.

17. An implantable orthopedic device for repairing an anatomical joint at a treatment site of a human or animal and improving a joint condition, the implantable orthopedic device comprising: a) a first portion comprising a joint-facing end, an opposite mating end, and a sidewall extending between the joint-facing end and the mating end; wherein the joint-facing end includes a plurality of first window holes; and wherein the first portion further comprises a central hole configured to cooperate with the introducer; and b) a second portion comprising a mating end, an opposite front end, and a side wall extending between the mating end and the front end, the side wall having an inner wall and an outer wall, wherein the side wall of the second portion includes a protrusion on an inner wall, an outer wall, or a combination thereof; wherein the leading end comprises an edge that first penetrates bone during implantation; and wherein the side wall of the second portion further comprises a plurality of second window holes between the protrusions, wherein the implantable orthopedic device has a width and a length, wherein the width and length of the implantable orthopedic device each comprise an aspect ratio between approximately 0.3 and 3.0; Therein, the implantable orthopedic device has a washer attachable to the joint-facing end of the first portion.

18. The implantable orthopedic device of claim 17, wherein: (i) the gasket has a geometry that includes a convex, concave, or flat profile when viewed in a cross-sectional side perspective; or (ii) the geometry of the gasket is configured as a bowl to contain biomaterial and promote tissue ingrowth at the treatment site, and the geometry of the gasket includes a chamber that contains biomaterial and engages tissue at the treatment site; (iii) the gasket is configured to be partially or completely absorbed within a period of time after the gasket is attached to the implantable orthopedic device at the treatment site, the gasket being configured to promote guided tissue regeneration; (iv) the geometry of the gasket can be independently customized and configured to match the topography of the bone at the treatment site; (v) The attachable gasket includes a threaded attachment, a fork attachment, a slide-lock attachment, a snap attachment, or a notched attachment.

19. The implantable orthopedic device of claim 18, wherein (ii) the geometry of the gasket is configured as a bowl to contain biomaterial and promote tissue ingrowth at the treatment site, and the geometry of the gasket includes a chamber that contains biomaterial and engages tissue at the treatment site; and Wherein the chamber has an overhanging lip configured to retain the biological material.

20. An implantable orthopedic device for repairing an anatomical joint and improving a joint condition at a treatment site of a human or animal, the implantable orthopedic device comprising: a) a first portion comprising a joint-facing end, an opposite mating end, and a sidewall extending between the joint-facing end and the mating end; wherein the joint-facing end includes a plurality of first window holes; and wherein the first portion further comprises a central hole configured to cooperate with the introducer; and b) a second portion comprising a mating end, an opposite front end, and a side wall extending between the mating end and the front end, the side wall having an inner wall and an outer wall, wherein the side wall of the second portion includes a protrusion on an inner wall, an outer wall, or a combination thereof; wherein the leading end comprises an edge that first penetrates bone during implantation; and wherein the side wall of the second portion further comprises a plurality of second window holes between the protrusions, Wherein the implantable orthopedic device has a width and a length, wherein the width and length of the implantable orthopedic device each comprise an aspect ratio between approximately 0.3 and 3.

0.

21. The implantable orthopedic device of any one of claims 1-20, wherein: The first portion further includes: a peripheral column partially forming the side wall of the first portion; and a central column at least partially located within the peripheral column; Each first window opening is formed by the junction of the peripheral pillar and the central pillar; and The central hole is located in and formed by the central post.

22. The implantable orthopedic device of claim 21, further comprising at least three struts, each strut extending between and connecting the peripheral struts and the central strut, and each strut supporting the central strut thereby.

23. An implantable orthopedic device according to any one of claims 1 to 22, wherein: The side wall of the second portion includes protrusions on the inner wall and the outer wall, The protrusion on the inner wall extends from the inner wall and at least partially toward a longitudinal center axis of the implantable orthopedic device; The protrusion on the outer wall extends from the outer wall and at least partially away from a longitudinal center axis of the implantable orthopedic device; and The protrusions on the inner wall and the protrusions on the outer wall are each configured to engage bone when the implantable orthopedic device is implanted in a treatment site.

24. An implantable orthopedic device according to any one of claims 1 to 23, wherein: The implantable orthopedic device comprises at least one of the following features: The side wall of the second portion has a taper from the mating end to the front end; an outer wall of the side wall of the second portion having a taper from the mating end to the front end between about 1.0 degrees and 9.0 degrees; The inner wall of the side wall of the second portion has a taper between about 1.0 degrees and 9.0 degrees from the mating end to the front end; The protrusions include a variable pitch design or a uniform pitch design; or The protrusion is selected from the group consisting of reverse cutting threads, notched threads, tapered threads, buttress threads, metric threads, trapezoidal threads, ram threads, pipe straight threads, unified threads, custom threads, and multiple threads.

25. An implantable orthopedic device according to any one of claims 1 to 24, wherein: The implantable orthopedic device is configured to be implanted in a bone at the treatment site, and the bone is subchondral bone.

26. A kit for repairing an anatomical joint, the kit comprising: An implantable orthopedic device according to any one of claims 1 to 25; Dimensional measuring equipment; Guide wire; Countersink instruments; Hollow drill; Drill guide; drill; Sleeve; Driving equipment; syringe; Inflatable capsule; at least one biological material; Instructions for use; as well as a package containing the implantable orthopedic device, the sizing instrument, the guide wire, the countersinking instrument, the core drill, the drill guide, the drill bit, the sleeve, the driving instrument, the syringe, the inflatable envelope, the at least one biomaterial, and the instructions for use; and Wherein the kit is sterilizable.

27. An implantable orthopedic device according to any one of claims 1 to 26, wherein: The mating end of the second portion includes a non-threaded press-fit portion configured to substantially seal against lubricating fluid; and wherein The implantable orthopedic device includes a blind-ended central bore extending only partially through the joint-facing end of the implantable orthopedic device such that synovial fluid leakage is reduced or prevented.

28. An implantable orthopedic device according to any one of claims 1 to 27, wherein: wherein the plurality of first fenestrations and the plurality of first fenestrations are of variable size to provide support for different tissue types and promote healing repair at the treatment site; wherein the plurality of second fenestrations between the protrusions on the second portion of the sidewall have a size between about 300 microns and 1200 microns to promote bone growth; The plurality of first fenestrations on the joint-facing end of the first portion may have a size between about 400 microns and 800 microns to promote cartilage growth.

29. An implantable orthopedic device according to any one of claims 1 to 28, wherein: The outer surface of the implantable orthopedic device is at least partially textured to increase the surface area of ​​the implantable orthopedic device to provide enhanced compressive, tensile, and / or shear stress attenuation at the treatment site; wherein the at least partially textured texture comprises a pattern of dimples or a pattern within a pattern configuration; and Wherein the outer surface is a biomaterial that promotes tissue growth, tissue differentiation and / or tissue attraction.

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