CARTILAGE TREATMENT

Abstract

Apparatus is provided for treating hyaline cartilage of a subject, the apparatus including a chondral implant, which includes a first exposed electrode surface and which is configured to be implanted in osteochondral tissue of the subject. A second exposed electrode surface is configured to be implanted in a body of the subject. Control circuitry is configured to promote regeneration of the hyaline cartilage by driving the first and the second exposed electrode surfaces to drive nutrients toward the first exposed electrode surface. Other embodiments are also described.

Claims

1-20. (canceled)

21. Apparatus for treating hyaline cartilage of a subject, the apparatus comprising: a chondral implant, which comprises a first exposed electrode surface and which is configured to be implanted in osteochondral tissue of the subject; a second exposed electrode surface, which is configured to be implanted in a body of the subject; and control circuitry, which is configured to promote regeneration of the hyaline cartilage by driving the first and the second exposed electrode surfaces to drive nutrients toward the first exposed electrode surface.

22. The apparatus according to claim 21, wherein the first exposed electrode surface has a surface area of 1-30 cm2.

23. The apparatus according to claim 21, wherein the control circuitry is configured to configure the first exposed electrode surface to be a cathode and the second exposed electrode surface to be an anode.

24. The apparatus according to claim 21, wherein the control circuitry is configured to apply a voltage of 0.1-1.1 V between the first and the second exposed electrode surfaces.

25. The apparatus according to claim 21, wherein the control circuitry is configured to drive the first and the second exposed electrode surfaces to electroosmotically drive fluid containing the nutrients toward the first exposed electrode surface.

26. The apparatus according to claim 25, wherein the control circuitry is configured to cyclically: drive the first and the second exposed electrode surfaces to electroosmotically drive the nutrient-containing fluid toward the first exposed electrode surface, and provide rest periods during which the nutrient-containing fluid is not electroosmotically driven toward the first exposed electrode surface.

27. The apparatus according to claim 21, wherein the chondral implant comprises a synthetic scaffold, and wherein the first exposed electrode surface comprises an electrically-conductive material of the synthetic scaffold.

28. The apparatus according to claim 27, wherein the electrically-conductive material comprises carbon fiber.

29. The apparatus according to claim 28, wherein the carbon fiber is hollow carbon fiber.

30. The apparatus according to claim 27, wherein the electrically-conductive material comprises a biocompatible bioresorbable conductive porous material.

31. The apparatus according to claim 27, wherein the electrically-conductive material is shaped as a thin layer.

32. The apparatus according to claim 21, wherein the chondral implant comprises one or more synthetic materials that are configured to stimulate the hyaline cartilage regeneration.

33. The apparatus according to claim 32, wherein the chondral implant comprises a synthetic scaffold that is configured to stimulate the hyaline cartilage regeneration.

34. The apparatus according to claim 33, wherein the first exposed electrode surface is coupled to the synthetic scaffold, and wherein the chondral implant is configured to be implanted such that the first exposed electrode surface is located deeper within the osteochondral tissue than the synthetic scaffold.

35. The apparatus according to claim 34, wherein the synthetic scaffold is shaped as a thin layer.

36. The apparatus according to claim 33, wherein the synthetic scaffold comprises a layer of fibrin glue.

37. The apparatus according to claim 33, wherein the synthetic scaffold is biphasic.

38. The apparatus according to claim 21, wherein the chondral implant further comprises a tissue graft that is configured to stimulate the hyaline cartilage regeneration.

39. The apparatus according to claim 38, wherein the first exposed electrode surface is coupled to the tissue graft, and the chondral implant is configured to be implanted such that the first exposed electrode surface is located deeper within the osteochondral tissue than the tissue graft.

40. The apparatus according to claim 21, wherein the chondral implant is configured to be implanted in a chondral defect of the hyaline cartilage.

41. The apparatus according to claim 40, wherein the chondral implant comprises an osteochondral plug that is configured to stimulate the hyaline cartilage regeneration in the chondral defect.

42. The apparatus according to claim 41, wherein the first exposed electrode surface is located in a transition zone of the osteochondral plug between a chondral layer of the osteochondral plug and a subchondral bone layer of the osteochondral plug.

43. The apparatus according to claim 41, wherein the osteochondral plug comprises naturally-derived cartilage.

44. The apparatus according to claim 41, wherein the osteochondral plug comprises a biocompatible, artificial material.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] FIG. 1 is a schematic illustration of a cartilage treatment system for treating hyaline cartilage, in accordance with an application of the present invention;

[0021] FIG. 2 is a schematic illustration of another cartilage treatment system for treating hyaline cartilage, in accordance with an application of the present invention; and

[0022] FIG. 3 is a schematic illustration of yet another cartilage treatment system for treating hyaline cartilage, in accordance with an application of the present invention.

DETAILED DESCRIPTION OF APPLICATIONS

[0023] FIG. 1 is a schematic illustration of a cartilage treatment system 20 for treating hyaline cartilage 22 of a subject, in accordance with an application of the present invention. Cartilage treatment system 20 comprises: [0024] a first electrode 24, which comprises a first exposed electrode surface 26, which is configured to be implanted in osteochondral tissue 28 of the subject (osteochondral tissue 28 is composed of subchondral bone 40 and hyaline cartilage 22); [0025] a second electrode 30, which comprises a second exposed electrode surface 32, which is configured to be implanted in a body 34 of the subject; and [0026] control circuitry 36, which is configured to promote regeneration of hyaline cartilage 22 by driving first and second exposed electrode surfaces 26 and 32 to drive nutrients toward first exposed electrode surface 26 (optionally, because of a charge of the nutrients).

[0027] As used in the present application, including in the claims, “nutrients” are substances used by cells (chondrocytes) within hyaline cartilage 22 to survive and reproduce. As used in the present application, including in the claims, oxygen is considered a nutrient, because oxygen is essential for the survival and reproduction of cells.

[0028] For some applications, first exposed electrode surface 26 is the external surface of a non-insulated portion of a wire of first electrode 24, such as shown in FIG. 1. Alternatively, first exposed electrode surface 26 comprises a separate element that is typically coupled to an insulated lead of first electrode 24.

[0029] Alternatively or additionally, for some applications, second exposed electrode surface 32 is the external surface of a non-insulated portion of a wire of second electrode 30, such as shown in FIG. 1. Alternatively, second exposed electrode surface 32 comprises a separate element that is typically coupled to an insulated lead of second electrode 30.

[0030] Typically, control circuitry 36 is configured to drive first and second exposed electrode surfaces 26 and 32 to electroosmotically drive fluid containing the nutrients toward first exposed electrode surface 26.

[0031] For some applications, first exposed electrode surface 26 is configured to be implanted: [0032] within subchondral bone 40 of osteochondral tissue 28, such as shown in FIG. 1, [0033] in physical contact with an external surface 44 of subchondral bone 40 (configuration not shown), [0034] in hyaline cartilage 22 of osteochondral tissue 28 (configuration not shown), or [0035] partially in subchondral bone 40, partially in physical contact with external surface 44 of subchondral bone 40, and partially in hyaline cartilage 22, or at two of these three sites (configurations not shown).

[0036] For some applications, first exposed electrode surface 26 has a surface area of at least 1 cm2, no more than 30 cm2 (e.g., no more than 10 cm2), and/or 1-30 cm2, e.g., 1-10 cm2.

[0037] For some applications, second exposed electrode surface 32 is configured to be implanted: [0038] in physical contact with synovial fluid 46 in a joint cavity 48 of a joint capsule 50 of the subject, such as shown in FIG. 1, and/or [0039] in physical contact with a capsular ligament 52 of joint capsule 50 of the subject (configuration not shown).

[0040] For some applications, at least a portion of control circuitry 36 is configured to be implanted within body 34 (e.g., by injection), such as shown in FIG. 1.

[0041] For some applications, cartilage treatment system 20 comprises an implantable controller 42, which comprises at least a portion of control circuitry 36, optionally all of control circuitry 36. Optionally, control circuitry 36 does not comprise any active electronic components; for example, control circuitry 36 may comprise one or more passive diodes that are configured to rectify the current generated in the coil of control circuitry 36. Alternatively, for some applications, control circuitry 36 comprises a battery configured to be implanted in body 34.

[0042] For some applications, cartilage treatment system 20 further comprises an external unit 38, which is configured to be disposed external to body 34, such as against the skin of the body, and which is configured to wirelessly transmit power (via a coil) to a coil of implantable controller 42, and optionally to wirelessly submit control signals. Optionally, external unit 38 comprises a portion of control circuitry 36.

[0043] Typically, control circuitry 36 is configured to configure first exposed electrode surface 26 to be a cathode and second exposed electrode surface 32 to be an anode. (The plus and minus signs in FIGS. 1 and 2 schematically illustrate the negative and positive charges of the cathode and anode, respectively.)

[0044] For some applications, control circuitry 36 is configured to apply a voltage between first and second exposed electrode surfaces 26 and 32. Typically, the voltage is at least 0.1 V, no more than 1.1 V, and/or 0.1-1.1 V).

[0045] For some applications, control circuitry 36 is configured to drive first and second exposed electrode surfaces 26 and 32 to apply a constant current.

[0046] For some applications, control circuitry 36 is configured to drive direct current between first and second exposed electrode surfaces 26 and 32. For some applications, control circuitry 36 is configured to drive the direct current as a series of pulses.

[0047] For some applications in which control circuitry 36 is configured to drive first and second exposed electrode surfaces 26 and 32 to electroosmotically drive fluid containing the nutrients toward first exposed electrode surface 26, control circuitry 36 is configured to cyclically: [0048] drive first and second exposed electrode surfaces 26 and 32 to electroosmotically drive the nutrient-containing fluid toward first exposed electrode surface 26, and [0049] provide rest periods during which the nutrient-containing fluid is not electroosmotically driven toward first exposed electrode surface 26.

[0050] The rest periods may allow any excess fluid driven toward first exposed electrode surface 26 to flow in the opposite direction. For example, control circuitry 36 may be configured to electroosmotically drive the nutrient-containing fluid toward first exposed electrode surface 26 for periods of time having a duration of between 3 and 10 minutes, e.g., 5 minutes, and to provide the rest periods having respective durations of between 1 and 3 minutes, e.g., 2 minutes.

[0051] Optionally, control circuitry 36 is configured to sense a voltage between first and second exposed electrode surfaces 26 and 32 during each rest period, and upon detection of a reduction to below a threshold value, again begin electroosmotically driving the nutrient-containing fluid toward first exposed electrode surface 26.

[0052] Reference is still made to FIG. 1. In an application of the present invention, a method of treating hyaline cartilage of a subject is provided, the method comprising: [0053] implanting first exposed electrode surface 26 in osteochondral tissue 28; [0054] implanting second exposed electrode surface 32 in body 34; and [0055] promoting regeneration of hyaline cartilage 22 by activating control circuitry 36 to drive first and second exposed electrode surfaces 26 and 32 to drive nutrients toward first exposed electrode surface 26.

[0056] For some applications, the method further comprises identifying that the subject suffers from osteoarthritis, and first and second exposed electrode surfaces 26 and 32 are implanted responsively to identifying that the subject suffers from the osteoarthritis.

[0057] For some applications, first exposed electrode surface 26 is implanted: [0058] within subchondral bone 40 of osteochondral tissue 28, such as shown in FIG. 1, [0059] in physical contact with external surface 44 of subchondral bone 40 (configuration not shown), [0060] in hyaline cartilage 22 of osteochondral tissue 28 (configuration not shown), or [0061] partially in subchondral bone 40, partially in physical contact with external surface 44 of subchondral bone 40, and partially in hyaline cartilage 22, or at two of these three sites (configurations not shown).

[0062] For some applications, first exposed electrode surface 26 is implanted in osteochondral tissue 28 such that at least a portion of first exposed electrode surface 26 is under a chondral defect 56 of hyaline cartilage 22. Alternatively or additionally, for some applications, first exposed electrode surface 26 is implanted in osteochondral tissue 28 such that at least a portion of first exposed electrode surface 26 is not under a chondral defect 56.

[0063] For some applications, second exposed electrode surface 32 is implanted: [0064] in physical contact with synovial fluid 46 in joint cavity 48 of joint capsule 50, and/or [0065] in physical contact with capsular ligament 52 of joint capsule 50.

[0066] For some applications, the method further comprises implanting at least a portion of control circuitry 36 within body 34.

[0067] Reference is now made to FIG. 2, which is a schematic illustration of a portion of cartilage treatment system 120 for treating hyaline cartilage 22 of a subject, in accordance with an application of the present invention. Other than as described below, cartilage treatment system 120 is generally similar to cartilage treatment system 20 described hereinabove with reference to FIG. 1, and may implement any features thereof, mutatis mutandis. Like reference numerals refer to like parts.

[0068] Cartilage treatment system 120 further comprises a chondral implant 154, which comprises a first exposed electrode surface 126. Chondral implant 154 is configured to stimulate hyaline cartilage regeneration in a chondral defect 56 of hyaline cartilage 22. Control circuitry 36 may implement all of the features described hereinabove with reference to FIG. 1 by driving first exposed electrode surface 126 instead of first exposed electrode surface 26, mutatis mutandis.

[0069] For some applications, first exposed electrode surface 126 has a surface area of at least 1 cm2, no more than 30 cm2 (e.g., no more than 10 cm2), and/or 1-30 cm2, e.g., 1-10 cm2.

[0070] Optionally, cartilage treatment system 120 further comprises first exposed electrode surface 26, described hereinabove with reference to FIG. 1 (configuration not shown).

[0071] For some applications, chondral implant 154 comprises one or more synthetic materials that are configured to stimulate hyaline cartilage regeneration. For some of these applications, chondral implant 154 comprises a synthetic scaffold 160 that is configured to stimulate hyaline cartilage regeneration. For example, synthetic scaffold 160 may comprise an electrically-conductive material (e.g., comprising carbon fiber (e.g., a nanomaterial), such as hollow carbon fiber) that serves as first exposed electrode surface 126. For some applications, the electrically-conductive material comprises a biocompatible bioresorbable conductive porous material (e.g., arranged as a membrane). Optionally, the electrically-conductive material is shaped as a thin layer and/or as a mesh.

[0072] For some applications, first exposed electrode surface 126 is coupled to synthetic scaffold 160, and wherein chondral implant 154 is configured to be implanted such that first exposed electrode surface 126 is located deeper within osteochondral tissue 28 than synthetic scaffold 160.

[0073] For some applications, synthetic scaffold 160 is shaped as a thin layer (e.g., 0.1-2 mm thick, e.g., 1 mm thick).

[0074] For some applications, synthetic scaffold 160 comprises an outer layer of fibrin glue 162. Outer layer of fibrin glue 162 may be added to synthetic scaffold 160 during the implantation procedure, or pre-attached to the synthetic scaffold. Fibrin is permeable to nutrients, including oxygen, and thus does not interfere with the driving of the nutrients toward first exposed electrode surface 26.

[0075] For some applications, synthetic scaffold 160 is biphasic (i.e., comprises first and second regions, e.g., layers, specific for the growth of respective particular tissue types, such as cartilage and bone, respectively).

[0076] For some applications, chondral implant 154 comprises a biological tissue graft that is configured to stimulate hyaline cartilage regeneration. For example, the biological tissue graft may be autologous, e.g., implementing osteochondral allograft transplantation (OATS) or matrix-associated autologous chondrocyte implantation (MACI), as are known in the cartilage repair art.

[0077] For some of these applications, first exposed electrode surface 126 is coupled to the biological tissue graft, and chondral implant 154 is configured to be implanted such that first exposed electrode surface 126 is located deeper within osteochondral tissue 28 than the biological tissue graft.

[0078] For some applications, chondral implant 154 is configured to be implanted in chondral defect 56 of hyaline cartilage 22. For some of these applications, chondral implant 154 comprises an osteochondral plug that is configured to stimulate hyaline cartilage regeneration in chondral defect 56. Optionally, first exposed electrode surface 126 is located in a transition zone of the osteochondral plug between a chondral layer of the osteochondral plug and a subchondral bone layer of the osteochondral plug. For some applications, the osteochondral plug comprises naturally-derived cartilage. Alternatively, the osteochondral plug comprises a biocompatible, artificial material. Optionally, the osteochondral plug is cylindrical. The osteochondral plug may or may not comprise cells, as is known in the osteochondral plug art. For example, the osteochondral plug may implement techniques described in U.S. Pat. No. 6,632,246 to Simon et al.

[0079] Reference is still made to FIG. 1. In an application of the present invention, a method of treating hyaline cartilage of a subject is provided. Implanting first exposed electrode surface 26 in osteochondral tissue 28 comprises implanting chondral implant 154 that includes first exposed electrode surface 126.

[0080] For some applications, second exposed electrode surface 32 is implanted at a non-zero distance from chondral implant 154.

[0081] For some applications in which first exposed electrode surface 126 is coupled to synthetic scaffold 160, and implanting chondral implant 154 is implanted such that first exposed electrode surface 126 is located deeper within osteochondral tissue 28 than synthetic scaffold 160.

[0082] For some applications in which first exposed electrode surface 126 is coupled to the biological tissue graft, and chondral implant 154 is implanted such that first exposed electrode surface 126 is located deeper within osteochondral tissue 28 than the biological tissue graft.

[0083] For some applications, chondral implant 154 is implanted in chondral defect 56 of hyaline cartilage 22.

[0084] Reference is now made to FIG. 3, which is a schematic illustration of a cartilage treatment system 220 for treating hyaline cartilage 22 of a subject, in accordance with an application of the present invention. Other than as described below, cartilage treatment system 220 is generally similar to cartilage treatment systems 20 and 120 described hereinabove with reference to FIGS. 1 and 2, respectively, and may implement any features thereof, mutatis mutandis. Like reference numerals refer to like parts. Cartilage treatment system 220 is configured to be used with a physician programmer 270, which may be implemented, for example, on a conventional smartphone, which may or may not be an element of cartilage treatment system 220. Physician programmer 270 may be used to wirelessly submit control signals to external unit 38, described hereinabove with reference to FIG. 1. For example, the control signals may include setting of personalized treatment parameters.

[0085] Optionally, cartilage treatment system 220 further comprises a knee brace 272, into which external unit 38 is incorporated.

[0086] Although cartilage treatment systems 20, 120, and 120 are illustrated as treating a knee joint, the systems may also be used to treat other synovial joints, such a hip joint, a shoulder joint, a finger joint (e.g., a knuckle joint), a toe joint, an ankle joint, an elbow joint, or a wrist. In addition, the cartilage treatment systems may be configured to treat other tissues, such as meniscus of the knee.

[0087] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.