AMELIORATING JOINT CONDITIONS INCLUDING INJURIES AND DISEASES

Abstract

A method for ameliorating joint conditions and diseases and preventing bone hypertrophy can include facilitating cartilage regrowth and preventing bone overgrowth to a damaged bone at a treatment site within a body joint to promote healing. The method can include providing a device having a first section comprising a joint-ward end having an inner surface and an outer surface and fenestrations between the inner and outer surfaces. A second section can include an opposing leading end and a lateral wall extending between the joint-ward end and the leading end. The leading end can be penetrated into the bone to a depth to substantially position:1) the joint-ward end in a cartilage zone or at a boundary/transition area; and 2) the second section in the bone. Bone overgrowth into the cartilage zone may be prevented within the body joint when the device is positioned at the treatment site.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 16/840,132, entitled “Ameliorating Joint Conditions Including Injuries And Diseases,” filed on Apr. 3, 2020, which is a continuation of U.S. patent application Ser. No. 15/148,894, entitled “Method For Ameliorating Joint Conditions And Diseases And Preventing Bone Hypertrophy,” filed on May 6, 2016; now U.S. Pat. No. 10,610,364; which is a continuation-in-part of U.S. patent application Ser. No. 14/603,586, entitled “Method and Device for Ameliorating Joint Conditions and Diseases,” filed on Jan. 23, 2015, now U.S. Pat. No. 9,532,878; which is a divisional of U.S. patent application Ser. No. 13/421,792, entitled “Method and Device for Ameliorating Joint Conditions and Diseases,” filed on Mar. 15, 2012, now U.S. Pat. No. 8,968,404; which is a continuation-in-part of U.S. patent application Ser. No. 12/328,493, entitled “Joint Support and Subchondral Support System,” filed Dec. 4, 2008. U.S. patent application Ser. No. 15/148,894 also claims the benefit of and priority to U.S. Patent Application 62/260,030, entitled “Methods, Systems, and Devices for Repairing Anatomical Joint Conditions” filed on Nov. 25, 2015. The contents of each of the applications listed in this paragraph are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

There are a variety of conditions and diseases that impair the integrity and function of human joints. Among these joint conditions and diseases are arthroses, chondromalacia patella, isolated chondral defect, juvenile idiopathic arthritis, ligamentous deficiency arthroses, osteoarthritis (degenerative arthritis or degenerative joint disease), osteonecrosis, osteochondritis dissecans, patellar instability, post-ligamentous injury arthritis, post-meniscectomy arthritis, post-meniscectomy arthroses, post-traumatic arthritis, rheumatoid arthritis and septic arthritis. The incidence of arthritides alone in the United States exceeds 20%, with higher rates among women as compared to men. Treatment of joint conditions and diseases includes surgery and the administration of therapeutic agents. However, none of these treatments ameliorate all of the joint conditions and diseases.

Therefore, there is a need for a new method for ameliorating joint conditions and diseases.

BRIEF SUMMARY OF THE INVENTION

According to one embodiment of the present invention, there is provided a device for ameliorating joint conditions and diseases. The device comprises a) a first section comprising a joint-ward end, an opposing mating end, and a lateral wall extending between the joint-ward end and the mating end, where the first section further comprises a peripheral column partially forming the lateral wall of the first section, a central column, and three or more than three struts, each strut extending between and connecting the peripheral column and the central column, and each strut thereby supporting the central column, where the joint-ward end further comprises a plurality of fenestrations, where each fenestration is formed by a confluence of the peripheral column, the central column and two adjacent struts of the three or more than three struts, and where the first section further comprises a central aperture within and formed by the central column, and configured to mate with a driver, b) a second section comprising a mating end, an opposing leading end, and a lateral wall extending between the mating end and the leading end, where the lateral wall of the second section comprises threads.

In one embodiment, the device further comprises an axial length, and the axial length is between 5 mm and 30 mm. In another embodiment, the device further comprises an axial length, and the axial length is between 5 mm and 20 mm. In another embodiment, the device further comprises an axial length, and the axial length is between 8 mm and 16 mm. In one embodiment, the first section further comprises a diameter between 5 mm and 30 mm. In another embodiment, the first section further comprises a diameter between 5 mm and 20 mm. In another embodiment, the first section further comprises a diameter between 8 mm and 16 mm. In another embodiment, the first section further comprises an axial length between 1 mm and 2 mm.

In one embodiment, each fenestration comprises a pear or teardrop shape. In another embodiment, one or more than one fenestration comprises a different size, different shape or both a different size and a different shape than one or more than one other fenestration.

In one embodiment, the central aperture comprises a six-pointed star shape. In another embodiment, the central aperture is round and comprises threads. In one embodiment, the peripheral column comprises one or more than one notch.

In one embodiment, the joint-ward end comprises a convex profile as seen on a cross-sectional, lateral perspective view. In another embodiment, the joint-ward end comprises a concave profile as seen on a cross-sectional, lateral perspective view. In another embodiment, the joint-ward end comprises a straight profile as seen on a cross-sectional, lateral perspective view. In one embodiment, the joint-ward end comprises a radius of curvature of between 20 mm and 50 mm. In another embodiment, the joint-ward end comprises a radius of curvature of between 15 mm and 45 mm. In another embodiment, the lateral wall of the first section comprises a generally convex profile as seen on a cross-sectional, lateral perspective view.

In one embodiment, the second section further comprises an axial length between 5 mm and 30 mm. In another embodiment, the second section further comprises an axial length between 5 mm and 20 mm. In another embodiment, the second section further comprises an axial length between 6 mm and 15 mm. In one embodiment, the lateral wall of the second section is generally cylindrical. In another embodiment, the lateral wall of the second section is generally conical, tapering between the mating end and the leading end. In one embodiment, the lateral wall of the second section tapers between 0.2 degrees and 15 degrees. In another embodiment, the lateral wall of the second section tapers between 1 degrees and 5 degrees. In another embodiment, the lateral wall of the second section tapers between 1 degrees and 3 degrees.

In one embodiment, the mating end of the first section and the mating end of the second section mate by a biocompatible adhesive. In another embodiment, the mating end of the first section and the mating end of the second section mate by a mating mechanism that is reversible. In another embodiment, the mating end of the first section and the mating end of the second section mate by a reversible twist locking mechanism. In another embodiment, the first section and the second section are made as a unified whole.

In one embodiment, the leading end comprises a scalloped edge. In another embodiment, the leading end comprises bevels. In another embodiment, the leading end comprises both a scalloped edge and bevels.

In one embodiment, the lateral wall of the second section further comprises a plurality of fenestrations between the threads. In another embodiment, the device further comprises a plurality of fenestrations formed by a confluence of the mating end of the first section and the mating end of the second section. In one embodiment, the device further comprises an insert, where the insert comprises a base and three or more than three extensions connected to the base and arranged radially around the base, and where each of the three or more than three extensions is configured to fit within a corresponding fenestration of the joint-ward end of first section of the device. In one embodiment, the insert further comprises porous biological material impregnated with matrix-promoting substances or serves as a scaffold for progenitor cells, or comprises both porous biological material impregnated with matrix-promoting substances and serves as a scaffold for progenitor cells.

According to another embodiment of the present invention, there is provided a method for ameliorating a joint condition or disease in a patient. The method comprises a) identifying a patient with a joint condition or disease that is suitable for treatment by the method, where the joint comprises a bone with a surface comprising a defect caused by the joint condition or disease, b) accessing the joint, c) placing a guidepin within the center of the defect, d) creating a space in the defect of the bone, e) providing a first device according to the present invention, f) attaching the first device to a driver by mating the distal end of the driver with the central aperture of the first device, and g) screwing the first device into the space using the driver until the joint-ward end of the first device forms a shape that substantially recreates the shape of a normal articulation surface on the bone after implantation.

In one embodiment, the joint is a diarthrodial joint. In another embodiment, the joint is selected from the group consisting of an acetabulofemoral joint, an acromioclavicular joint, a femoropatellar joint, a femorotibial joint, a glenohumeral joint, a humeroradial joint, a humeroulnar joint, an interphalangeal joint, a metacarpal joint, a radioulnar joint and a talocrural joint. In one embodiment, the patient is a human. In one embodiment, the patient is a non-human animal. In one embodiment, the joint condition and disease is selected from the group consisting of arthroses, chondromalacia patella, isolated chondral defect, juvenile idiopathic arthritis, ligamentous deficiency arthroses, osteoarthritis (degenerative arthritis or degenerative joint disease), osteonecrosis, osteochondritis dissecans, patellar instability, post-ligamentous injury arthritis, post-meniscectomy arthritis, post-meniscectomy arthroses, post-traumatic arthritis, rheumatoid arthritis and septic arthritis.

In one embodiment, identifying the patient comprises diagnosing the patient with a joint condition and disease. In another embodiment, diagnosing the patient comprises performing one or more than one of action selected from the group consisting of performing a physical examination, performing a non-invasive imaging examination and performing arthroscopy. In one embodiment, identifying the patient comprises consulting patient records to determine if the patient has a joint condition or disease suitable for treatment by the method. In one embodiment, accessing the joint is accomplished by arthroscopy. In one embodiment, the joint is accomplished by an open surgical procedure.

In one embodiment, the surface of the bone comprises one or more than one abnormality, and the method further comprises using a burr, or a suction shaver, or both a burr and a suction shaver to remove some or all of the one or more than one abnormality thereby creating a smoother articulation surface. In one embodiment, the method further comprises creating one or more than one vascular channel in the bone deep to the space using a drill bit guide positioned over the guidepin and a drill bit passed within the drill bit guide. In another embodiment, the method further comprises injecting a biological material into the first device. In one embodiment, the method further comprises placing an insert in the first device. In one embodiment, the method further comprises placing one or more than one additional device in the defect.

According to yet another embodiment, there is provided a method of facilitating cartilage regrowth and preventing bone overgrowth to a damaged bone at a treatment site within a body joint to promote healing. The method comprises providing a device having a first section comprising a joint-ward end having an inner surface and an outer surface and fenestrations between the inner and outer surfaces and a second section comprising an opposing leading end and a lateral wall extending between the joint-ward end and the leading end. The leading end is penetrated into the bone to a depth to substantially position: 1) the joint-ward end in a cartilage zone; wherein the outer surface of the joint-ward end is configured to facilitate cartilage regrowth; and 2) the second section in the bone; wherein the inner surface of the joint-ward end is configured to prevent bone overgrowth into the cartilage zone within the body joint when the device is positioned at the treatment site.

According to other embodiments, the device is positioned and configured to provide active or passive dampening support to the bone at the treatment site so as to dissipate and dampen shock within the bone to promote healing. The second section includes fenestrations, the fenestrations are configured to promote osseointegration of the second section at the treatment site. The joint-ward end is substantially positioned at a transition area between a cartilage layer and a bone layer such that cartilage can grow through, around and over the fenestrations in the joint-ward end. The cartilage is articular cartilage and healing includes mitigating bone hypertrophy. The fenestrations promote intracellular nutrient transmission. The transition area is located substantially in a cortical bone base plate or located substantially between cancellous bone and a cartilage zone. The device inhibits bone growth into a cartilage zone when the device is positioned at the treatment site. The device also prevents bone fracture when the device is positioned at the treatment site. The body joint may be a knee and the treatment site may include a subchondral lesion. Mitigating bone hypertrophy may include preventing trabecular thickening of the cancellous bone, for example. A thickness of cartilage regrowth at the treatment site is substantially uniform after healing and/or is substantially the same as a thickness of healthy cartilage adjacent the treatment site after healing. The device is made of titanium and at least the outer surface of the joint-ward end is coated with hydroxyapatite. The first section and second section may be reversibly attached or fused together.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying figures where:

FIG. 1 is a lateral perspective view of one embodiment of a device for ameliorating joint conditions and diseases according to the present invention;

FIG. 2 is a top, lateral perspective view of another embodiment of a device for ameliorating joint conditions and diseases according to the present invention;

FIG. 3 is an exploded, top, lateral perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1;

FIG. 4 is a top perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1;

FIG. 5 is a bottom perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1;

FIG. 6 is a top perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 2;

FIG. 7 is a top perspective view of another embodiment of the device for ameliorating joint conditions and diseases according to the present invention;

FIG. 8 is a top perspective view of another embodiment of the device for ameliorating joint conditions and diseases according to the present invention;

FIG. 9 is a cross-sectional, lateral perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1 taken along line 9-9;

FIG. 10 is a cross-sectional, lateral perspective view of another embodiment of the device for ameliorating joint conditions and diseases according to the present invention;

FIG. 11 is a cross-sectional, lateral perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 2 taken along line 11-11;

FIG. 12 is a top, lateral perspective view of one embodiment of an insert according to the present invention for use with a device for ameliorating joint conditions and diseases according to the present invention;

FIG. 13 is a bottom, lateral perspective view of the embodiment of the insert shown in FIG. 12;

FIG. 14 is a top, lateral perspective view of one embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1 with the insert shown in FIG. 12 according to the present invention affixed to the device;

FIG. 15 is a cross-sectional view of the device for ameliorating joint conditions and diseases shown in FIG. 1 with the insert shown in FIG. 12 according to the present invention affixed to the device; and

FIG. 16 through FIG. 35 are schematic depictions of some steps of a method for ameliorating joint conditions and diseases according to the present invention.

FIG. 36 is a cross-sectional view of anatomical regions at a treatment site.

FIG. 37A is a cross-sectional view of a lesion in a damaged bone.

FIG. 37B is a cross-sectional view of cartilage growth over hypertrophied bone.

FIG. 38A is an embodiment of the device according to the present invention.

FIG. 38B is an embodiment of the device according to the present invention showing cartilage growth during healing.

DETAILED DESCRIPTION OF THE INVENTION

According to one embodiment of the present invention, there is provided a device for ameliorating joint conditions and diseases. According to another embodiment of the present invention, there is provided a method for ameliorating a joint condition or disease in a patient. In one embodiment, the method comprises providing a device according to the present invention. The device and methods will now be disclosed in detail.

As used in this disclosure, except where the context requires otherwise, the term “comprise” and variations of the term, such as “comprising,” “comprises” and “comprised” are not intended to exclude other additives, components, integers or steps.

As used in this disclosure, except where the context requires otherwise, the method steps disclosed and shown are not intended to be limiting nor are they intended to indicate that each step is essential to the method or that each step must occur in the order disclosed but instead are exemplary steps only.

All dimensions specified in this disclosure are by way of example only and are not intended to be limiting, except where the context requires otherwise. Further, the proportions shown in these Figures are not necessarily to scale. As will be understood by those with skill in the art with reference to this disclosure, the actual dimensions and proportions of any device or part of a device disclosed in this disclosure will be determined by its intended use.

According to one embodiment of the present invention, there is provided a device for ameliorating joint conditions and diseases. Referring now to FIG. 1 through FIG. 11, there are shown, respectively, a lateral perspective view of one embodiment of a device for ameliorating joint conditions and diseases according to the present invention (FIG. 1); a top, lateral perspective view of another embodiment of a device for ameliorating joint conditions and diseases according to the present invention (FIG. 2); an exploded, top, lateral perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1 (FIG. 3); a top perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1 (FIG. 4); a bottom perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1 (FIG. 5); a top perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 2 (FIG. 6); a top perspective view of another embodiment of the device for ameliorating joint conditions and diseases according to the present invention (FIG. 7); a top perspective view of another embodiment of the device for ameliorating joint conditions and diseases according to the present invention (FIG. 8); a cross-sectional, lateral perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1 taken along line 9-9 (FIG. 9); a cross-sectional, lateral perspective view of another embodiment of the device for ameliorating joint conditions and diseases according to the present invention (FIG. 10); and a cross-sectional, lateral perspective view of the embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 2 taken along line 11-11 (FIG. 11). As can be seen, the device 10 comprises a first section 12 and a second section 14, and comprises a generally cylindrical shape partially or completely closed at one end. The device 10 further comprises an axial length (a-a). In one embodiment, the axial length (a-a) is between 5 mm and 30 mm. In another embodiment, the axial length (a-a) is between 5 mm and 20 mm. In another embodiment, the axial length (a-a) is between 8 mm and 16 mm. In a preferred embodiment, the axial length (a-a) is 8 mm. In another preferred embodiment, the axial length (a-a) is 12 mm. In another preferred embodiment, the axial length (a-a) is 16 mm.

The first section 12 of the device 10 comprises a joint-ward end 16, an opposing mating end 18, and a lateral wall 20 extending between the joint-ward end 16 and the mating end 18. The first section 12 further comprises a diameter (d-d) and an axial length (b-b). In one embodiment, the diameter (d-d) is between 5 mm and 30 mm. In another embodiment, the diameter (d-d) is between 5 mm and 20 mm. In another embodiment, the diameter (d-d) is between 8 mm and 16 mm. In a preferred embodiment, the diameter (d-d) is 8 mm. In another preferred embodiment, the diameter (d-d) is 12 mm. In another preferred embodiment, the diameter (d-d) is 16 mm. In one embodiment, the axial length (b-b) is between 0.5 mm and 2.5 mm. In another embodiment, the axial length (b-b) is between 1 mm and 2 mm. In a preferred embodiment, the axial length (b-b) is 1.25 mm.

In one embodiment, the first section 12 further comprises a peripheral column 22 partially forming the lateral wall 20, a central column 24, and three or more than three 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.

In one embodiment, the joint-ward end 16 further comprises a plurality of fenestrations 28, where each fenestration 28 is formed by a confluence of the peripheral column 22, the central column 24, and two adjacent struts 26 of the three or more than three struts 26. Each fenestration 28 can comprise any shape suitable for the intended purpose of the device 10, as will be understood by those with skill in the art with respect to this disclosure. In one embodiment, as shown particularly in FIG. 2, FIG. 3, FIG. 4, FIG. 5, FIG. 6 and FIG. 7, each fenestration 28 comprises a pear or teardrop shape. In another embodiment, as shown in FIG. 8, each fenestration 28 comprises a kidney shape. In another embodiment, each fenestration 28 comprises an oval or a round shape. As will be understood by those with skill in the art with respect to this disclosure, all fenestrations 28 on the device 10 can comprise the same size and shape or one or more than one fenestration 28 can comprise a different size, different shape or both a different size and a different shape than one or more than one other fenestration 28. In another embodiment, the joint-ward end 16 can be solid between the central column 24 and the peripheral column 22.

The first section 12 further comprises a central aperture 30 within and formed by the central column 24. The central aperture 30 can extend axially completely through the joint-ward end 16 as shown particularly in FIG. 9, FIG. 10 and FIG. 11, or can be blind-ended extending only partially through within joint-ward end 16. The central aperture 30 is configured to mate with a driver as disclosed below. The central aperture 30 comprises any shape suitable for the intended purpose of the device 10, as will be understood by those with skill in the art with respect to this disclosure. In one embodiment, the central aperture 30 comprises a square shape. In one embodiment, as shown in FIG. 2 and FIG. 6, the central aperture 30 comprises a round shape. In another embodiment, as shown in FIG. 3, FIG. 4 and FIG. 5, the central aperture 30 comprises a six-pointed star shape. In another embodiment, as shown in FIG. 7, the central aperture 30 comprises a pentagonal shape. In another embodiment, as shown in FIG. 8, the central aperture 30 comprises a hexagonal shape. In one embodiment, as shown in FIG. 2 and FIG. 11, the central aperture 30 comprises threads 32 to assist in mating with a driver.

In one embodiment, peripheral column 22 of the first section 12 comprises one or more than one notch 34 as seen in FIG. 2, FIG. 6 and FIG. 11. The one or more than one notch can be used to mate with a driver in addition to the central aperture 30 or instead of the central aperture 30, as will be understood by those with skill in the art with respect to this disclosure.

The joint-ward end 16 of the first section 12 of the device 10 performs a partial load-bearing function after implantation, and comprises a shape suitable to substantially match the shape of the articulation surface that the device 10 recreates on the bone after implantation, as will be understood by those with skill in the art with respect to this disclosure. Therefore, the joint-ward end 16 can have either a convex profile as seen on a cross-sectional, lateral perspective view, as shown in FIG. 9 and FIG. 11, a concave profile as seen on a cross-sectional, lateral perspective view, as shown in FIG. 10, or a straight profile as seen on a cross-sectional, lateral perspective view. In one embodiment, the joint-ward end has a convex profile having a radius of curvature of between 10 mm and 50 mm. In another embodiment, the joint-ward end has a convex profile as seen on a cross-sectional, lateral perspective view with a radius of curvature of between 15 mm and 45 mm. In another embodiment, the joint-ward end has a convex profile as seen on a cross-sectional, lateral perspective view with a radius of curvature of between 20 mm and 30 mm. In one embodiment, the joint-ward end has a concave profile as seen on cross-sectional, lateral perspective view with a radius of curvature of between 10 mm and 50 mm. In another embodiment, the joint-ward end has a concave profile as seen on cross-sectional, lateral perspective view with a radius of curvature of between 15 mm and 45 mm. In another embodiment, the joint-ward end has a concave profile as seen on cross-sectional, lateral perspective view with a radius of curvature of between 20 mm and 30 mm. In a preferred embodiment, the joint-ward end 16 comprises a smooth surface facing the center of joint after implantation, as will be understood by those with skill in the art with respect to this disclosure. In a preferred embodiment, the joint-ward end 16 is polished to make the surface smooth.

The lateral wall 20 of the first section 12 can be any shape suitable for the intended purpose of the device 10, as will be understood by those with skill in the art with respect to this disclosure. In a preferred embodiment, the lateral wall 20 of the first section 12 comprises a generally convex profile as seen on a cross-sectional, lateral perspective view, as shown in FIG. 9 and FIG. 11. This convex profile advantageously provides a smooth transition to and encourages biologic bonding to surrounding cartilage and bone after implantation, as will be understood by those with skill in the art with respect to this disclosure.

The device 10 further comprises a second section 14. The second section 14 of the device 10 comprises a mating end 36, an opposing leading end 38, and a lateral wall 40 extending between the mating end 36 and the leading end 38. The second section 14 further comprises an axial length (c-c). In one embodiment, the axial length (c-c) is between 5 mm and 30 mm. In another embodiment, the axial length (c-c) is between 5 mm and 20 mm. In another embodiment, the axial length (c-c) is between 6 mm and 15 mm. In a preferred embodiment, the axial length (c-c) is 6 mm. In another preferred embodiment, the axial length (c-c) is 10 mm. In another preferred embodiment, the axial length (c-c) is 15 mm. In one embodiment, the lateral wall 40 of the second section 14 is generally cylindrical as seen in FIG. 1, FIG. 9 and FIG. 10. In another embodiment, the lateral wall 40 of the second section 14 is generally conical, tapering between the mating end 36 and the leading end 38 as seen in FIG. 11. In one embodiment, the lateral wall 40 of the second section 14 tapers between 0.2 degrees and 15 degrees. In another embodiment, the lateral wall 16 tapers between 1 degrees and 5 degrees. In another embodiment, the lateral wall 40 of the second section 14 tapers between 1 degrees and 3 degrees.

The mating end 36 of the second section 14 of the device 10 is configured to mate with the mating end 18 of the first section 12 of the device 10. The mating end 18 of the first section 12 and the mating end 36 of the second section 14 can comprise any mating mechanism suitable for the intended purpose of the device 10 can be used, as will be understood by those with skill in the art with respect to this disclosure. In one embodiment, the mating end 18 of the first section 12 and the mating end 36 of the second section 14 mate by a suitable biocompatible adhesive, as will be understood by those with skill in the art with respect to this disclosure. In a preferred embodiment, the mating mechanism is reversible, allowing an interchange of an alternate first section 12 to a specific second section 14 so that the device 10 can be reconfigured as needed for contouring to a particular joint surface, thereby decreasing the number of second sections 14 that need to be stored on site, as will be understood by those with skill in the art with respect to this disclosure. In one embodiment, the mating end 18 of the first section 12 and the mating end 36 of the second section 14 mate by a reversible twist locking mechanism, as will be understood by those with skill in the art with respect to this disclosure. In another embodiment, the first section 12 and the second section 14 are made as a unified whole as shown in FIG. 11 and are not separable.

The leading end 38 of the second section 14 of the device 10 is configured to place the device 10 into a prepared space made according to a method according to the present invention. In one embodiment, the leading end 38 comprises a scalloped edge 42. In another embodiment, the leading end 38 comprises bevels 44. In a preferred embodiment, the leading end 38 comprises both a scalloped edge 42 and bevels 44 as shown particularly in FIG. 1, FIG. 3, FIG. 5 and FIG. 6.

The lateral wall 40 of the second section 14 of the device 10 extends between the mating end 36 and the leading end 38. The lateral wall 40 of the second section 14 comprises threads 46 for anchoring the device 10 within the bone. In one embodiment, the lateral wall 40 of the second section 14 further comprises a plurality of fenestrations 48 between the threads 46. In a preferred embodiment, the device 10 further comprises a plurality of fenestrations 50 formed by a confluence of the mating end 18 of the first section 12 and the mating end 36 of the second section 14. Each fenestration 48, 50 can comprise any shape suitable for the intended purpose of the device 10, as will be understood by those with skill in the art with respect to this disclosure. In a preferred embodiment, each fenestration 48, 50 is oval or round. In one embodiment, the lateral wall 40 of the second section 14 is textured to promote bony ingrowth after implantation, as will be understood by those with skill in the art with respect to this disclosure.

The first section 12 and the second section 14 can comprise any material suitable for the intended purpose of the device 10, as will be understood by those with skill in the art with respect to this disclosure. In one embodiment, the first section 12 comprises a material selected from the group consisting of a biocompatible plastic, a biocomposite polymer, a metal and a metal alloy. In one embodiment, the first section 12 comprises a material selected from the group consisting of carbon fiber, cobalt chrome, nitinol, polycaprolactone (PCL), polyether-ether-ketone (PEEK), tantalum and titanium. In one embodiment, the second section 14 comprises a material selected from the group consisting of a biocompatible plastic, a biocomposite polymer, a metal and a metal alloy. In one embodiment, the second section 14 comprises a material selected from the group consisting of carbon fiber, cobalt chrome, nitinol, polycaprolactone (PCL), polyether-ether-ketone (PEEK), tantalum and titanium. In one embodiment, the first section 12 comprises a first material and the second section 14 comprises a second material, where the first material and the second material are the same material. In another embodiment, the first section 12 comprises a first material and the second section 14 comprises a second material, where the first material and the second material are the different materials.

In one embodiment, the device 10 further comprises an insert 52. Referring now to FIG. 12, FIG. 13, FIG. 14 and FIG. 15, there are shown, respectively, a top, lateral perspective view of one embodiment of an insert according to the present invention for use with a device for ameliorating joint conditions and diseases according to the present invention (FIG. 12); a bottom, lateral perspective view of the embodiment of the insert shown in FIG. 12 (FIG. 13); a top, lateral perspective view of one embodiment of the device for ameliorating joint conditions and diseases shown in FIG. 1 with the insert shown in FIG. 12 according to the present invention affixed to the device (FIG. 14); and a cross-sectional view of the device for ameliorating joint conditions and diseases shown in FIG. 1 with the insert shown in FIG. 12 (FIG. 15). As can be seen, the insert 52 comprises a base 54 and three or more than three extensions 56 connected to the base 54 and arranged radially around the base 54. Each of the three or more than three extensions 56 is configured to fit within a corresponding fenestration 28 of the joint-ward end 16 of the first section 12 of the device 10, such that when the insert 52 is mated to the first section 12 of the device 10, the insert 52 occupies each of the three or more than three fenestrations 28 as shown particularly in FIG. 5. The insert 52 comprises porous biological material impregnated with matrix-promoting substances or serves as a scaffold for progenitor cells, or comprises both porous biological material impregnated with matrix-promoting substances and serves as a scaffold for progenitor cells.

The device 10 can be made by any suitable method, as will be understood by those with skill in the art with respect to this disclosure. In one embodiment, the first section 12 and the second section 14 are machined from modular parts such as by direct metal laser sintering, as will be understood by those with skill in the art with respect to this disclosure.

According to another embodiment of the present invention, there is provided a method for ameliorating a joint condition or disease in a patient. Referring now to FIG. 16 through FIG. 35, there are shown schematic depictions of some steps of a method for ameliorating joint conditions and diseases according to the present invention. The Figures show the embodiment of the method being used on a femorotibial joint 100 to ameliorate an arthritic condition which has caused a defect 102 on an articulation surface 104 of a bone or joint, shown here as on the medial condyle 106 of the femur 108.

The method comprises identifying a patient with a joint condition or disease that is suitable for treatment by the present method, where the joint comprises a bone with a surface comprising a defect caused by the joint condition or disease. As will be understood by those with skill in the art with respect to this disclosure, the joint can be any joint with a hyaline cartilage bearing surface, joint capsule, and synovial fluid. In one embodiment, the joint is a diarthrodial joint (also known as a synovial joint). In one embodiment, the joint is selected from the group consisting of an acetabulofemoral joint, an acromioclavicular joint, a femoropatellar joint, a femorotibial joint, a glenohumeral joint, a humeroradial joint, a humeroulnar joint, an interphalangeal joint, a metacarpal joint, a radioulnar joint and a talocrural joint. In one embodiment, the patient is a human. In one embodiment, the patient is a non-human animal. In a preferred embodiment, the joint condition and disease is selected from the group consisting of arthroses, chondromalacia patella, isolated chondral defect, juvenile idiopathic arthritis, ligamentous deficiency arthroses, osteoarthritis (degenerative arthritis or degenerative joint disease), osteonecrosis, osteochondritis dissecans, patellar instability, post-ligamentous injury arthritis, post-meniscectomy arthritis, post-meniscectomy arthroses, post-traumatic arthritis, rheumatoid arthritis and septic arthritis. In one embodiment, identifying the patient comprises diagnosing the patient with a joint condition and disease. In one embodiment, diagnosing the patient comprises performing one or more than one of action selected from the group consisting of performing a physical examination, performing a non-invasive imaging examination (such as magnetic resonance imaging, computerized tomography and ultrasound) and performing arthroscopy. In another embodiment, identifying the patient comprises consulting patient records to determine if the patient has a joint condition or disease suitable for treatment by the present method.

Next, the method further comprises accessing the joint 100. In one embodiment, accessing the joint 100 is accomplished by arthroscopy. In another embodiment, accessing the joint 100 is accomplished by an open surgical procedure, such as for example a mini-open procedure.

In one embodiment, as shown in FIG. 17 and FIG. 18, the surface 104 of the bone comprises an abnormality 110 (such as for example area cartilage softening, thinning, damage, or absence), and the method further comprises using a burr, or a suction shaver, or both a burr and a suction shaver 112 to remove some or all of the abnormalities 110 thereby creating a smoother articulation surface 104 as shown in FIG. 19.

Then, the method further comprises placing a guidepin 114 within the center of the defect 102 as shown in FIG. 20.

Next, the method further comprises creating a space 116 in the defect 102 of the bone for a device. In one embodiment, the space 116 is created using a bone reamer 118 placed over the guidepin 114 to core and plane the surface of the defect 102 as shown in FIG. 21, FIG. 22 and FIG. 23. The bone reamer 118 is then removed leaving the guidepin 114 in place.

In one embodiment, the method further comprises creating one or more than one vascular channel in the bone deep to the space 116 using a drill bit guide 120 positioned over the guidepin 114 and a drill bit 122 passed within the drill bit guide 120 as shown in FIG. 23, FIG. 24 and FIG. 25. Confirmation of creation of the one or more than one vascular channel is made by the presence of blood 124 leaking into the space 116 from the one or more than one vascular channel. The drill bit guide 120 and drill bit 122 are then removed leaving the guidepin 114 in place.

Next, the method further comprises providing a first device 126 for ameliorating joint conditions and diseases suitable for ameliorating the joint condition or disease of the patient as can be seen in FIG. 26. In one embodiment, the first device 126 is a device according to the present invention. The first device 126 provided has a size suitable for incorporation into the space 116 made in the defect 102, and the joint-ward end of the first device 126 comprises a shape suitable to substantially match the shape of the articulation surface 104 that the first device 126 recreates on the bone after implantation, as will be understood by those with skill in the art with respect to this disclosure. Referring now to FIG. 27, the first device 126 is attached to a driver 128, such as for example by mating the distal end of the driver 128 with the central aperture of the first device 126.

In one embodiment, the method further comprises injecting a biologic material, such as for example stem cells or platelet rich plasma, or both stem cells and platelet rich plasma 130 into the first device 126 using an injector 132 as shown in FIG. 28. In one embodiment, the method further comprises placing an insert according to the present invention in the first device 126 instead of injecting a biocompatible bone cement in the first device 126. In one embodiment, the insert is a biological material according to the present invention.

Then, the method further comprises screwing the first device 126 into the space 116 using the driver 128, as shown in FIG. 29, FIG. 30, FIG. 31 and FIG. 32. FIG. 33 is a partial, lateral cross-section of the medial condyle 106 at the site of the defect 102 showing placement of the first device 126. As can be seen, the joint-ward end of the first device 126 forms a shape that substantially recreates the shape of a normal articulation surface on the bone after implantation.

In one embodiment, as can be seen in FIG. 26 and FIG. 34, the method further comprises placing one or more than one additional device 134, 136 in the defect 102. In one embodiment, the one or more than one additional device is one additional device. In another embodiment, one or more than one additional device is two additional devices. As will be understood by those with skill in the art with respect to this disclosure, the one or more than one additional device 134, 136 can be the same as the first device in terms of size and shape or can be different than the first device in terms of size and shape.

FIG. 36 shows a cross-sectional view of anatomical regions at a damaged bone 146. The regions include cancellous bone 137, a cortical bone base plate 138, and a cartilage zone 139. The cartilage zone 139 may include articular cartilage. Torn cartilage 140 is shown near an injury site 141.

Under natural healing conditions without medical intervention, the cortical bone base plate 138 tends to grow past a boundary/transition 143 of the cartilage zone 139 in a direction 142 toward the articulating body joint at the injury site 141 as shown in FIGS. 36 and 37A, for example. Under these conditions, it is not unusual to observe trabecular thickening of the cancellous bone as the body tries to compensate and protect against forces applied to the joint as it heals. As healing progresses without intervention, bone hypertrophy continues and one or more boney outcrops 144 often form which, in turn, leaves a cartilage layer 145a that is relatively thin and generally less healthy than a thickness of pristine cartilage adjacent 147a, 147b the damaged bone 146, as illustrated in FIG. 37B. Unfortunately, this often results in suboptimal healing for the patient—leaving the bone vulnerable to additional trauma and the body joint subject to repeated injuries.

An embodiment of the present invention includes a new, useful and non-obvious method of facilitating cartilage regrowth and preventing bone overgrowth to a damaged bone at a treatment site within a body joint to promote healing and avoid the scenario described above and shown in FIGS. 37A and 37B.

With reference to FIGS. 3 and 38A, an embodiment of the device according to the present invention is disclosed. The device 10 has a first section 12 comprising a joint-ward end 16 having an inner surface 16a and an outer surface 16b and fenestrations 28 between the inner 16a and outer 16b surfaces. A second section 14 comprises an opposing leading end 38 and a lateral wall 40 extending between the joint-ward end 16 and the leading end 38. The leading end 38 is penetrated into the bone to a depth to substantially position: 1) the joint-ward end 16 in a cartilage zone 139; wherein the outer surface of the joint-ward end 16 is configured to facilitate cartilage regrowth; and 2) the second section 14 in the bone 137; wherein the inner surface 16a of the joint-ward end 16 is configured to prevent bone overgrowth into the cartilage zone 139 within the body joint when the device is positioned at the treatment site. Thus, as shown in FIG. 38B, optimal healing is advanced by mitigating bone hypertrophy and facilitating cartilage regrowth. Mitigating bone hypertrophy may include preventing trabecular thickening of the cancellous bone. Per FIG. 38B, cartilage may be encouraged to regrow over the injured bone at a thickness 145b at the treatment site that is substantially uniform after healing and may also be substantially the same as a thickness of healthy (i.e. pristine) cartilage adjacent 147a, 147b the treatment site after healing. In this manner, a patient progresses to a more optimal healed state. The bone is better protected from additional trauma and is less likely to fracture when the device is positioned at the treatment site. The body joint is also less likely to experience repeated subsequent injuries.

Advantageously, the device 10 is positioned and configured to provide active or passive dampening support to the bone at the treatment/injury site 141 so as to dissipate and dampen shock within the bone to promote healing. This may prevent excessive thickening of the cancellous bone. The second section 14 includes fenestrations 48 and these fenestrations are configured to promote osseointegration of the second section at the treatment site. This provides stability. Furthermore, as discussed in U.S. Patent Application 62/260,030, entitled “Methods, Systems, and Devices for Repairing Anatomical Joint Conditions” filed on Nov. 25, 2015, which is pending, the contents of which are incorporated herein by reference, the fenestrations may have different porosities targeted to promote specific tissue growth and differentiation. For example, the fenestrations may be different sizes conducive to facilitating cartilage regrowth on outer surface 16b of the joint-ward end 16 and to prevent bone overgrowth into the cartilage zone 139 within the body joint on the inner surface 16a of the joint-ward end 16. The joint-ward end 16 may be substantially positioned at a boundary/transition area 143 between a cartilage layer and a bone layer such that cartilage can grow through and around and even over the top of the fenestrations 28 in the joint-ward end 16. The transition area 143 may be located substantially in a cortical bone base plate or located substantially between cancellous bone and a cartilage zone, for example.

The plurality of fenestrations between the protrusions (e.g. treads, notches) 46 on the second section of the lateral wall are between about 300 microns and 1200 microns in size to promote bone growth while the plurality of fenestrations on the joint-ward end of the first section are between about 100 microns to 800 microns in size to promote cartilage growth. Preferably, the plurality of fenestrations on the joint-ward end 16 of the first section are between about 400 microns to 800 microns in size to promote cartilage growth. Circular pores, pie-shaped fenestrations and other shapes are considered.

Though the method of the present invention has been disclosed with respect to a defect 102 in a femorotibial joint 100, corresponding methods can be used with other joints. FIG. 35 is a partial, lateral cross-section of a glenohumeral joint 138 at the site of a defect showing placement of a device for ameliorating joint conditions and diseases according to the present invention.

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 preferred embodiments contained in this disclosure.

Claims

1. A method of promoting healing in or adjacent to a portion of a bone layer at a treatment site within a body joint, the method comprising:

providing an implantable device having a body formed of material, the implantable device comprising: an axis defining an axial direction of the device; a first section comprising: a joint-ward end having an inner surface and an outer surface spaced apart from one another along the axial direction of the device, the joint-ward end further having first fenestrations extending fully through the joint-ward end in a manner that includes extending between and through the inner surface of the joint-ward end and the convex or concave profile of the outer surface of the joint-ward end; and a second section arranged along the axial direction from the first section and comprising: an opposing leading end; and a lateral wall extending between the joint-ward end and the leading end, wherein the lateral wall is configured to engage the bone layer at the treatment site;

penetrating the leading end into the bone layer to a depth;

positioning the second section in the bone layer; and

positioning the joint-ward end in a position to facilitate transmission through the first fenestrations into a cartilage zone by positioning the joint-ward end at a transition area substantially between a cartilage layer in the cartilage zone and the bone layer at the treatment site such that the joint-ward end is beneath the cartilage zone or otherwise not extending entirely through the cartilage zone.

2. The method of claim 1, wherein the lateral wall comprises threads configured to engage the bone layer at the treatment site.

3. The method of claim 1, wherein the lateral wall further comprises second fenestrations configured to promote osseointegration of the second section at the treatment site.

4. The method of claim 1, wherein the first fenestrations promote intracellular nutrient transmission; or

wherein the joint-ward end is substantially positioned such that cartilage can grow through, around, and over the first fenestrations in the joint-ward end.

5. The method of claim 1, wherein the cartilage is articular cartilage; or

wherein the bone layer is a cortical bone base plate.

6. The method of claim 1, wherein healing includes mitigating bone hypertrophy when the joint-ward end is positioned at the transition area so as to protect against forces applied to the body joint.

7. The method of claim 6, wherein mitigating bone hypertrophy includes preventing trabecular thickening of cancellous bone.

8. The method of claim 1, wherein the transition area is located substantially in a cortical bone base plate; or

wherein the transition area is located substantially between cancellous bone and the cartilage zone.

9. The method of claim 1, wherein the device inhibits bone growth into the cartilage zone when the joint-ward end is positioned at the transition area; or

wherein the device prevents bone fracture when the joint-ward end is positioned at the transition area thus protecting against forces applied to the body joint.

10. The method of claim 1, wherein at least one of:

the body joint is a knee, shoulder, elbow, wrist, hip, spine ankle, or finger; or

the treatment site includes a subchondral lesion.

11. The method of claim 1, wherein the joint is selected from the group consisting of an acetabulofemoral joint, an acromioclavicular joint, a femoropatellar joint, a femorotibial joint, a glenohumeral joint, a humeroradial joint, a humeroulnar joint, an interphalangeal joint, a metacarpal joint, a radioulnar joint and a talocrural joint.

12. The method of claim 1, wherein a thickness of cartilage regrowth at the treatment site is substantially uniform after healing; or

wherein a thickness of cartilage regrowth at the treatment site is substantially the same as a thickness of healthy native cartilage adjacent the treatment site after healing.

13. The method of claim 1, wherein the device is made at least in part from titanium or alloys thereof.

14. The method of claim 1, wherein the device is made at least in part from non resorbable material.

15. The method of claim 1, wherein the device is made at least in part from polyether-ether-ketone (PEEK).

16. The method of claim 1, wherein the device is made at least in part from a partially absorbable material or a fully absorbable material.

17. The method of claim 1, wherein the device is made at least in part from and/or includes at least one of:

biocompatible plastic;

a biocomposite polymer;

a metal;

a metal alloy;

carbon fiber;

cobalt chrome;

nitinol;

polycaprolactone (PCL);

polyether-ether-ketone (PEEK);

tantalum;

titanium

foam metals;

ceramics;

ceramic composites;

elastomer composites;

elastomer-carbon fiber composites;

chambered or fluid-filled materials;

metal matrices;

injectable gels;

injectable composites with fluid and solid matrices;

bone or bone-composite or allografts;

crystal or hydroxyapatite materials;

bioabsorbable composites;

TCP;

PLLA;

silicone.

biomaterial;

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; or a replaceable material.

18. The method of claim 1, wherein at least the outer surface of the joint-ward end is coated with hydroxyapatite.

19. The method of claim 1, wherein the first section and the second section are reversibly attached.

20. The method of claim 1, wherein the first section and the second section are fused together.

21. The method of claim 1, wherein the lateral wall further comprises second fenestrations on the second section, wherein the second fenestrations are between 300 microns and 1200 microns in size.

22. The method of claim 1, wherein the first fenestrations on the joint-ward end of the first section are between 100 microns to 800 microns in size to promote cartilage regrowth.

23. The method of claim 1, wherein the joint-ward end is positioned at a boundary of the transition area, said boundary being located substantially between a cancellous bone and the cartilage zone.

24. The method of claim 1, wherein the joint-ward end forms a shape that substantially recreates the shape of a normal articulation surface on the bone after implantation when the joint-ward end is positioned at the treatment site.