SYNOVIAL SHUNTS

• US 20120150093A1
• Filed: 04/06/2010
• Published: 06/14/2012
• Est. Priority Date: 03/30/2009
• Status: Abandoned Application

• Current Assignee: Jointech Med Limited
• Original Assignee: Jointech Med Limited
• Inventors: Altschuler, Nir, Keren, Dvir, Shafrir, Roey, Goren, Amir
• Application Number:
  US13/262,239
• Publication Number:
  US 20120150093A1
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 2/30742 Bellows or hose-like seals; Sealing membranes A61B17/8808 takes precedence; sealing membranes for retaining bone substitute A61F2/2846
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2002/30675 Means for regulating synovial fluid pressure
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Shunt for joint repair, creates a passageway between interior and exterior of a joint capsule, the shunt comprising a body of biocompatible material, which is substantially hollow; a proximal and distal aperture flanking said shunt body; at least a first and second extension of shunt body, first extension is located proximal to proximal aperture and second extension is located proximal to distal aperture, first and second extensions fasten or adjoin said shunt body, such that said shunt is substantially immobilized at a location of placement of said shunt; proximal aperture of shunt body is positioned proximal to an interior of joint capsule and shunt body spans at least a distance equal to that of synovial membrane, joint capsule or a combination thereof and distal aperture is located substantially outside of at least synovial membrane; the ratio between shunt body diameter and shunt body length is greater than 0.5.

Claims

1-49. -49. (canceled)

50. A synovial shunt for insertion in a body joint, which shunt creates a passageway between an interior of a joint capsule and an exterior of said joint capsule, said shunt consisting of:

a shunt body comprised of a biocompatible material, which is substantially hollow;

a proximal and distal aperture flanking said shunt body; and

at least a first and second extension of said shunt body, which first extension is located proximal to said proximal aperture and which second extension is located proximal to said distal aperture, wherein said first and second extensions fasten or adjoin said shunt body, such that said shunt is substantially immobilized at a location of placement of said shunt;

wherein

said proximal aperture of said shunt body is positioned proximal to an interior of said joint capsule and said shunt body spans at least a distance substantially equal to that of said synovial membrane, said joint capsule or a combination thereof and said distal aperture is located substantially outside of at least said synovial membrane; and

the ratio between said shunt body diameter and said shunt body length is greater than 0.5.

51. The synovial shunt of claim 50, wherein said distal aperture is located proximal to a subcutaneous tissue and said shunt body spans a length across a synovial membrane and extending into a subcutaneous tissue,

said subcutaneous tissue is a muscle, a vein, fat, a ligament or a tendon, and

said distal aperture is located near an exterior of a joint capsule.

52. The synovial shunt of claim 50, wherein said shunt body has a thickness of between 50-300 μ

m,

said shunt body has a diameter of between 1-25 mm, and

said shunt body has a length of between 3-10 mm.

53. The synovial shunt of claim 50, wherein said shunt body length varies as a function of the thickness of subcutaneous tissue into which said synovial shunt will be implanted.

54. The synovial shunt of claim 50, wherein said first extension, said second extension or a combination thereof have a length of 2-20 mm.

55. The synovial shunt of claim 50, wherein said shunt is comprised of a metal, a ceramic, or a polymer.

56. The synovial shunt of claim 55, wherein said shunt is prepared from a single piece of metal.

57. The synovial shunt of claim 55, wherein said metal is nitinol, stainless steel, or titanium.

58. The synovial shunt of claim 55, wherein said polymer comprises a natural polymer comprising, collagen, elastin, silk, hyaluronic acid, chytosan, or any combinations thereof.

59. The synovial shunt of claim 55, wherein said polymer comprises a synthetic biodegradable polymer.

60. The synovial shunt of claim 59, wherein said synthetic biodegradable polymer comprises alpha-hydroxy acids including poly-lactic acid, polyglycolic acid, enantioners thereof, co-polymers thereof, polyorthoesters, or combinations thereof.

61. The synovial shunt of claim 50, wherein a luminal surface of said shunt, an exterior surface of said shunt or a combination thereof is treated to reduce adhesion of cells or particulate matter thereto.

62. The synovial shunt of claim 61, wherein said shunt comprises a coating, which diminishes or abrogates adhesion thereto.

63. The synovial shunt of claim 61, wherein said shunt comprises a positively charged material or incorporates a positively charged material.

64. The synovial shunt of claim 61, wherein said first extension, said second extension or a combination thereof are treated to reduce adhesion of cells or particulate matter thereto.

65. The synovial shunt of claim 61, and wherein said first extension, said second extension or a combination thereof are treated to promote adhesion to cells in a region to which said shunt is adhered.

66. The synovial shunt of claim 50, wherein a luminal surface of said shunt, an exterior surface of said shunt or a combination thereof comprises a therapeutic agent,

wherein said therapeutic agent comprises a growth factor, an agent which aides in wound repair, or a combination thereof and

wherein said therapeutic agent comprises an anticoagulant, an anti-inflammatory compound, or a combination thereof.

67. The synovial shunt of claim 50, wherein said first extension, said second extension or a combination thereof comprises a ring, a wing, a hook, a clip, a structure comprising teeth, or a combination thereof.

68. The synovial shunt of claim 50, wherein said first extension, said second extension or a combination thereof are positioned so as to be substantially parallel with respect to a long axis of said shunt body and

wherein said first extension, said second extension or a combination thereof may be extended from a position that is substantially parallel to a long axis of said shunt body to one that is at an angle of between 45 to 120 degrees with respect to a long axis of said shunt body.

69. The synovial shunt of claim 50, wherein said first extension, said second extension or a combination thereof are positioned at an angle of between 45 to 120 degrees with respect to a long axis of said shunt body.

70. The synovial shunt of claim 50, wherein said shunt body comprises two halves which may be fixedly joined upon insertion through a synovial membrane.

71. A therapeutic kit comprising the synovial shunt of claim 50, optionally further comprising a biocompatible tubing, which tubing is positioned proximal to said distal aperture and which tubing conveys synovial fluid away from an affected joint region, optionally further comprising a tool for the insertion of said synovial shunt in an affected joint region

wherein said tool is comprised of at least two parts, said first part comprising a pointed structure, which inserts within a joint capsule and said second part, operationally connected thereto, which second part delivers said synovial shunt to said joint capsule such that a proximal aperture of said shunt body is positioned proximal to an interior of said joint capsule

wherein said second part maintains said first extension and said second extension at a position that is substantially parallel to a long axis of said shunt body prior to positioning said shunt in an affected joint, and

wherein operation of said first and second part to insert said shunt into an affected joint region facilitates extension of said first extension and said second extension to be at an angle of between 45 to 120 degrees with respect to a long axis of said shunt body.

72. A method for draining synovial fluid from a joint in a subject in need thereof, the method comprising the step of affixing the synovial shunt of claim 50 in a synovial membrane in an affected joint such that said proximal aperture is positioned proximal to an interior of said joint capsule and said shunt body spans at least a distance substantially equal to that of said synovial membrane, said joint capsule or a combination thereof and said distal aperture is located substantially outside at least said synovial membrane, creating a passageway through said synovial membrane and providing an exit for excess synovial fluid in said joint, thereby being a method for draining synovial fluid from a joint in a subject

wherein said affected joint is a knee or hip joint,

wherein said synovial shunt is positioned at a lateral infra patellar or a lateral supra patellar region,

wherein said subject is a human subject, or said subject is an animal subject, and

wherein said subject is afflicted with a full thickness articular cartilage defect;

osteoarthritis, infection, rheumatoid arthritis, an autoimmune disease, a joint defect or a defect resulting from trauma, sports, or repetitive stress or

wherein said subject is afflicted with a Baker'"'"'s cyst.

73. A method for treating a joint disease or disorder in a subject, the method comprising the step of affixing the synovial shunt of claim 50 in a synovial membrane in an affected joint of said subject, such that said proximal aperture is positioned proximal to an interior of said joint capsule and said shunt body spans at least a distance substantially equal to that of said synovial membrane, said joint capsule or a combination thereof and said distal aperture is located substantially outside at least said synovial membrane, creating a passageway through said synovial membrane and providing an exit for synovial fluid, relief of intra joint pressure or a combination thereof in said joint, thereby being a method for treating a joint disease or disorder in a subject,

wherein said affected joint is a knee or hip joint,

wherein said synovial shunt is positioned at a lateral infra patellar or a lateral supra patellar region,

wherein said subject is a human subject or

wherein said subject is an animal subject,

wherein said subject is afflicted with a full thickness articular cartilage defect;

osteoarthritis, rheumatoid arthritis, joint inflammation, infection, a joint defect or a defect resulting from trauma, sports, or repetitive stress.

74. A method for treating a ganglion cyst in a subject, the method comprising the step of affixing the synovial shunt of claim 50 in a membrane of a ganglion cyst in a subject, such that said proximal aperture is positioned proximal to an interior of said cyst and said shunt body spans at least a distance substantially equal to that of said cyst membrane and said distal aperture is located substantially outside at least said cyst membrane, creating a passageway through said cyst membrane and providing an exit for fluid from within said ganglion cyst, thereby being a method for treating a ganglion cyst in a subject.