System, device, composition and method for treating and preventing avascular or osteonecrosis
First Claim
1. A system for treating and/or preventing the complications associated with avascular necrosis in the musculoskeletal system of a human or non-human patient which comprises:
- a. identifying the biological site in the musculoskeletal system of said patient in need of said treatment;
b. creating at least one channel from the exterior of said biological site in said musculoskeletal system into or distal to said site in a manner that facilitates access to said site; and
c. inserting into said at least one channel a combination comprising at least (i) a composition comprising an osteoinductive element, an osteoconductive element or both and (ii) a biologically compatible support member which substantially fills said channel and which provides support to the biological site in the musculoskeletal system of said patient pending formation of new bone and vasculature at said site.
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Accused Products
Abstract
A vascular necrosis of the hip is a common disease that usually affects a young, active patient population. As the disease progresses the undermined structural integrity of the subchondral bone leads to articular collapse and subsequent osteoarthrosis. The ideal treatment is one that hinders or arrests the progression of the disease averting articular collapse and a joint replacement surgery. Several non-surgical and surgical procedures have been described to treat avascular necrosis: core decompression, osteotomies of the hip, non-vascularized and vascularized bone grafts. The purpose of this paper is to describe a surgical strategy that attempts to address the multiple factors involved in the progression of the disease: deficits in structural support, increased intraosseous pressure and the bone healing process. This is accomplished through a routine core decompression procedure combined with the insertion of two bone interference screws into the subchondral bone of the femoral head to provide structural support and the use of osteoinductive bone allograft (demineralized bone matrix) in an effort to accelerate the bone response. Prospective studies are currently underway to assess long-term outcomes.
232 Citations
36 Claims
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1. A system for treating and/or preventing the complications associated with avascular necrosis in the musculoskeletal system of a human or non-human patient which comprises:
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a. identifying the biological site in the musculoskeletal system of said patient in need of said treatment;
b. creating at least one channel from the exterior of said biological site in said musculoskeletal system into or distal to said site in a manner that facilitates access to said site; and
c. inserting into said at least one channel a combination comprising at least (i) a composition comprising an osteoinductive element, an osteoconductive element or both and (ii) a biologically compatible support member which substantially fills said channel and which provides support to the biological site in the musculoskeletal system of said patient pending formation of new bone and vasculature at said site. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A kit for treating avascular necrosis in the musculoskeletal system of a human or non-human patient wherein said treating comprises:
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a. identifying the biological site in the musculoskeletal system of said patient in need of said treatment;
b. creating at least one channel from the exterior of said biological site in said musculoskeletal system distal or into said site in a manner that facilitates access to said site; and
c. inserting into said at least one channel a combination comprising at least (i) a composition comprising an osteoinductive element, an osteoconductive element or both and (ii) a biologically compatible support member which substantially fills said channel and which provides support to the biological site in the musculoskeletal system of said patient pending formation of new bone and vasculature at said site;
wherein said kit comprises;
i. at least one sterile or sterilizable drill bit for creating said channel;
ii. at least one composition comprising said osteoinductive element, said osteoconductive element or both;
iii. at least one biologically compatible support member; and
iv. at least one device adapted for insertion of said biologically compatible support member into said channel. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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- 29. A screw made from bone comprising a cylinder of bone, with or without taper, of a length between about 25 mm and about 35 mm, and a width of between about 5 mm and about 10 mm.
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35. A method of treating or preventing avascular necrosis in the femur of a human or non-human patient which comprises:
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a. Appropriately positioning the patient to provide access to the affected limb;
b. Forming an incision to permit exposure of the aspect of the femur affected by the avascular necrosis;
c. Creating an entry hole in the femur;
d. Inserting at least one guidewire into the femur directed toward the necrotic site and utilizing said guidewire as a guide to create at least one channel directed toward the site of necrosis, which channel may be tapped;
e. Removing said guidewire and introducing into said channel a bone-inducing amount of an osteoinductive substance;
f. Inserting into said channel at least one biocompatible support member; and
g. Closing said incision to permit healing. - View Dependent Claims (36)
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Specification