US20050131417A1 - Kit for treating bony defects - Google Patents
Kit for treating bony defects Download PDFInfo
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- US20050131417A1 US20050131417A1 US10/924,240 US92424004A US2005131417A1 US 20050131417 A1 US20050131417 A1 US 20050131417A1 US 92424004 A US92424004 A US 92424004A US 2005131417 A1 US2005131417 A1 US 2005131417A1
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- osteoinductive
- mixture
- container
- osteoconductive
- fill
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
- A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4601—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
- A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
Definitions
- the present invention relates generally to the field of materials adapted to replace or assist a component of the skeleton of a living body. More specifically, the present invention relates to a system that surgeons can use for healing and supporting bony defects.
- Bone grafts are commonly used in a wide variety of orthopedic procedures.
- bone graft is often used to aid the healing of bony defects.
- defects may arise from trauma or a pathologic condition, or the surgeon may require graft to support bony healing subsequent to a surgical procedure such as joint fusion or arthrodesis.
- Autogenous bone also called autograft
- autograft is generally considered to be the “gold standard” in terms of biological performance. Autograft is often collected from the patient's hip. However, collecting autograft from the patient's hip is associated with a significant incidence of post-operative pain and the potential for additional medical complications. In addition, the volume of autograft material available from the patient's hip may not be sufficient for the graft procedure.
- Allograft such as morselized granules of cortical and cancellous bone, provides an osteoconductive material with some compressive strength, which can be readily incorporated via the same healing process that occurs with autogenous bone.
- Osteoconductivity refers to a material's ability to provide a suitable structure or scaffold for the growth of new blood vessels and, ultimately, bone.
- DBM demineralized bone matrix
- Allograft which is demineralized during its processing is commonly referred to as DBM, or demineralized bone matrix.
- DBM is an osteoinductive material, meaning that it can lead to the formation of bone by recruiting mesenchymal stem cells from the surrounding tissues, and these cells can ultimately differentiate into new bone.
- the Optimesh® System (patented by Spineology, Inc. in U.S. Pat. Nos. 5,549,679; 5,571,189, 6,383,188; 6,620,162; 6,620,169 and U.S. Patent Application Nos.: 09/909,667 and 10/440,036 all of which are incorporated herein by reference) includes various tools and a porous container used to contain bone graft or other fill material when fusing intervertebral spaces and treating defects in intravertebral bones or other bones. While the current Optimesh® System utilizes the concept of fill material extrusion, it would be advantageous to capitalize on the characteristics of both the osteoconductive and osteoinductive materials.
- the present invention includes a method and apparatus for healing and supporting bony defects.
- the method and apparatus of the present invention combine the advantageous features of osteoconductive and osteoinductive allograft materials.
- the present invention capitalizes upon the unique properties of each component by utilizing a mesh container placed in a bony defect.
- the allograft mixture is injected into the mesh container such that the osteoconductive material provides compressive strength to support the bony defect and the osteoinductive material encourages bone growth to aid in the healing of the bony defect.
- the allograft mixture is formulated to be flowable, that is the material may be discharged from a small diameter tube of length significantly longer than the tube's diameter.
- the allograft mixture is also packable such that the mixture may fill a small mesh container or pouch so that the mesh fills to its geometric limits as it is filled with the allograft mixture.
- the allograft mixture includes non-demineralized cortical cancellous allograft granules or other suitable osteoconductive material, which may be fully contained by the mesh due to their physical size, and can thereby provide some structural strength to the bony defect.
- the granules provide a focus for load bearing or load sharing just as the pebbles in concrete.
- the ratio of cortical to cancellous allograft may be in the range of 25:75-100:0.
- the granules may be mixed with DBM or other suitable osteoinductive material, which is a fine particulate, and a lubricating carrier.
- DBM or other suitable osteoinductive material, which is a fine particulate, and a lubricating carrier.
- DBM or other suitable osteoinductive material
- a lubricating carrier As the mesh is filled with the cortical cancellous allograft granules, some of the particulate DBM may be retained within the filled mesh, but a portion of it may be free to flow out through the pores of the mesh. This results in a surrounding “halo” of osteoinductive material at the margins of the filled mesh, in direct apposition with the surrounding host tissue where it can initiate recruitment of the stem cells, thus encouraging bone growth to heal the bony defect.
- the allograft mixture may generally be comprised of three components: non-demineralized cortical cancellous allograft granules or other suitable osteoconductive material, demineralized bone matrix (“DBM”) or other suitable osteoinductive material and sodium hyaluronan (HA), or other suitable lubricating carrier.
- the non-demineralized cortical cancellous allograft granules may generally be 200-2000 microns in size and may have an aspect ratio of about 1.5 longer than wide.
- the DBM may generally be 100-1000 microns in size and tends to be more uniform and rounded in shape.
- the lubricating carrier may generally be a viscous liquid, for example, sodium hyaluronan in varying molecular weights, alginate, dextran, gelatin, collagen and others.
- the DBM is more likely than the non-demineralized granules to be suspended in the lubricating carrier due to the geometric and size difference between the DBM and the non-demineralized granules.
- Ceramic materials may be added as alternatives to the cortical cancellous granules.
- the ceramics are also load bearing, load sharing, and osteoconductive.
- the ceramic material formulation may include, for example, calcium hydroxyapatite, tricalcium phosphate and calcium sulfate among others. Calcium hydroxyapatite resorbs very slowly, over a period of years. Tricalcium phosphate resorbs slowly, in about 3-6 months. Calcium sulfate resorbs more quickly, in less than 3 months.
- the tendency for the DBM to flow with the carrier is particularly noticeable when the mixture is delivered and packed into the mesh container 10 .
- the DBM particles flow through the mesh pores under the force applied by the emptying of the filled tube into the confined mesh container.
- the smaller of the DBM particles flow through the mesh pores into the bony defect.
- These DBM particles are the sole osteoinductive elements in the mixture.
- the DBM makes intimate contact with the irregular surfaces of the bony defect and consequently causes new bone to grow precisely at the surfaces where bony fusion is intended.
- the mesh pores may act as a sieve or filter that preferentially retains the non-demineralized granules. This filtering feature may allow the larger, irregularly shaped granules to pack tightly together within the mesh while the fluid component, also carrying the particles of DBM, may fill the interstices of the packed granules and flow through the pores of the mesh.
- the relationship between the sizes of the DBM, the mesh pores and the granules may generally be described as follows: If the granules have a size equal to X, then the DBM size may generally be in the range of 0.3-0.7 ⁇ and the pore size may generally be in the range of 0.5-2.5X.
- the formulation of the mixture may generally be in the range of about 2 parts DBM, 8 parts non-demineralized allograft granules and 8 parts lubricating carrier.
- the non-demineralized granules are primarily osteoconductive (supporting bone growth on the surface, but not strongly inducing growth), while the DBM is both osteoconductive and osteoinductive (encourages bone to grow). Because the DBM is osteoinductive, as the DBM flows out of the mesh pores in the fluid carrier, the DBM creates an increased potential for bone growth surrounding the mesh container, at the host-mesh interface, which may help to speed bony healing, or incorporation of the mesh and graft into the host bone structure.
- a single mesh container 10 may have varying pore sizes, resulting in a differential porosity. That is, where the pores are larger, more fill material will flow out of the pores and where the pores are smaller less fill material will flow out of the pores.
- This differential porosity allows the surgeon to direct the flow of material out of the mesh pores and thus optimize the placement of the osteoinductive DBM more precisely to promote bony growth at the defect site.
- FIG. 3 shows a preferred tool 20 , patented as U.S. Pat. No. 6,620,169 to Spineology, Inc, that may be used to process and inject the fill material mixture.
- the tool 20 shown in FIG. 3 is used to process the fill material mixture and inject the mixture into fill tubes.
- FIG. 4 shows the preferred embodiment where the fill material mixture is extruded from a fill tube 30 having at least one opening to direct the flow of the fill material mixture into the porous container 10 for optimal fill material placement.
- bone morphogenic protein for example, bone morphogenic protein, vascular endothelial growth factor, platelet derived growth factor, insulin-like growth factor, chondrocyte growth factor, fibroblast growth factor, antiviral agents, antibiotic agents and others may be added to the formulation.
Abstract
Description
- The present invention relates generally to the field of materials adapted to replace or assist a component of the skeleton of a living body. More specifically, the present invention relates to a system that surgeons can use for healing and supporting bony defects.
- Bone grafts are commonly used in a wide variety of orthopedic procedures. In particular, bone graft is often used to aid the healing of bony defects. Such defects may arise from trauma or a pathologic condition, or the surgeon may require graft to support bony healing subsequent to a surgical procedure such as joint fusion or arthrodesis.
- Autogenous bone, also called autograft, is generally considered to be the “gold standard” in terms of biological performance. Autograft is often collected from the patient's hip. However, collecting autograft from the patient's hip is associated with a significant incidence of post-operative pain and the potential for additional medical complications. In addition, the volume of autograft material available from the patient's hip may not be sufficient for the graft procedure.
- Specially processed donor bone, or allograft, is frequently used as an alternative to autograft. Allograft, such as morselized granules of cortical and cancellous bone, provides an osteoconductive material with some compressive strength, which can be readily incorporated via the same healing process that occurs with autogenous bone. Osteoconductivity refers to a material's ability to provide a suitable structure or scaffold for the growth of new blood vessels and, ultimately, bone.
- Allograft which is demineralized during its processing is commonly referred to as DBM, or demineralized bone matrix. DBM is an osteoinductive material, meaning that it can lead to the formation of bone by recruiting mesenchymal stem cells from the surrounding tissues, and these cells can ultimately differentiate into new bone.
- The Optimesh® System (patented by Spineology, Inc. in U.S. Pat. Nos. 5,549,679; 5,571,189, 6,383,188; 6,620,162; 6,620,169 and U.S. Patent Application Nos.: 09/909,667 and 10/440,036 all of which are incorporated herein by reference) includes various tools and a porous container used to contain bone graft or other fill material when fusing intervertebral spaces and treating defects in intravertebral bones or other bones. While the current Optimesh® System utilizes the concept of fill material extrusion, it would be advantageous to capitalize on the characteristics of both the osteoconductive and osteoinductive materials.
- To maximize the benefits of osteoinductive and osteoconductive fill materials, there is a need for carefully selecting and controlling the fill material flow into bony defects. It would be a particularly useful improvement to the Optimesh® System to fill the porous container with a fill material mixture that is filtered, under pressure, by the container such that bone inducing material flows out of the porous container and contacts the surrounding tissue, while the container restrains osteoconductive material in the container to provide support and rigidity to the defect.
- The present invention includes a method and apparatus for healing and supporting bony defects. The method and apparatus of the present invention combine the advantageous features of osteoconductive and osteoinductive allograft materials. The present invention capitalizes upon the unique properties of each component by utilizing a mesh container placed in a bony defect. The allograft mixture is injected into the mesh container such that the osteoconductive material provides compressive strength to support the bony defect and the osteoinductive material encourages bone growth to aid in the healing of the bony defect.
- The allograft mixture is formulated to be flowable, that is the material may be discharged from a small diameter tube of length significantly longer than the tube's diameter. The allograft mixture is also packable such that the mixture may fill a small mesh container or pouch so that the mesh fills to its geometric limits as it is filled with the allograft mixture.
- The allograft mixture includes non-demineralized cortical cancellous allograft granules or other suitable osteoconductive material, which may be fully contained by the mesh due to their physical size, and can thereby provide some structural strength to the bony defect. The granules provide a focus for load bearing or load sharing just as the pebbles in concrete. The ratio of cortical to cancellous allograft may be in the range of 25:75-100:0.
- The granules may be mixed with DBM or other suitable osteoinductive material, which is a fine particulate, and a lubricating carrier. As the mesh is filled with the cortical cancellous allograft granules, some of the particulate DBM may be retained within the filled mesh, but a portion of it may be free to flow out through the pores of the mesh. This results in a surrounding “halo” of osteoinductive material at the margins of the filled mesh, in direct apposition with the surrounding host tissue where it can initiate recruitment of the stem cells, thus encouraging bone growth to heal the bony defect.
- The allograft mixture may generally be comprised of three components: non-demineralized cortical cancellous allograft granules or other suitable osteoconductive material, demineralized bone matrix (“DBM”) or other suitable osteoinductive material and sodium hyaluronan (HA), or other suitable lubricating carrier. The non-demineralized cortical cancellous allograft granules may generally be 200-2000 microns in size and may have an aspect ratio of about 1.5 longer than wide. The DBM may generally be 100-1000 microns in size and tends to be more uniform and rounded in shape. The lubricating carrier may generally be a viscous liquid, for example, sodium hyaluronan in varying molecular weights, alginate, dextran, gelatin, collagen and others. The DBM is more likely than the non-demineralized granules to be suspended in the lubricating carrier due to the geometric and size difference between the DBM and the non-demineralized granules.
- Ceramic materials may be added as alternatives to the cortical cancellous granules. The ceramics are also load bearing, load sharing, and osteoconductive. The ceramic material formulation may include, for example, calcium hydroxyapatite, tricalcium phosphate and calcium sulfate among others. Calcium hydroxyapatite resorbs very slowly, over a period of years. Tricalcium phosphate resorbs slowly, in about 3-6 months. Calcium sulfate resorbs more quickly, in less than 3 months.
- As shown in
FIG. 1 , the tendency for the DBM to flow with the carrier is particularly noticeable when the mixture is delivered and packed into themesh container 10. The DBM particles flow through the mesh pores under the force applied by the emptying of the filled tube into the confined mesh container. The smaller of the DBM particles flow through the mesh pores into the bony defect. These DBM particles are the sole osteoinductive elements in the mixture. As the DBM is forced through the mesh pores, the DBM makes intimate contact with the irregular surfaces of the bony defect and consequently causes new bone to grow precisely at the surfaces where bony fusion is intended. - The mesh pores, generally about 250-5000 microns, may act as a sieve or filter that preferentially retains the non-demineralized granules. This filtering feature may allow the larger, irregularly shaped granules to pack tightly together within the mesh while the fluid component, also carrying the particles of DBM, may fill the interstices of the packed granules and flow through the pores of the mesh.
- The relationship between the sizes of the DBM, the mesh pores and the granules may generally be described as follows: If the granules have a size equal to X, then the DBM size may generally be in the range of 0.3-0.7× and the pore size may generally be in the range of 0.5-2.5X.
- The formulation of the mixture may generally be in the range of about 2 parts DBM, 8 parts non-demineralized allograft granules and 8 parts lubricating carrier.
- The non-demineralized granules are primarily osteoconductive (supporting bone growth on the surface, but not strongly inducing growth), while the DBM is both osteoconductive and osteoinductive (encourages bone to grow). Because the DBM is osteoinductive, as the DBM flows out of the mesh pores in the fluid carrier, the DBM creates an increased potential for bone growth surrounding the mesh container, at the host-mesh interface, which may help to speed bony healing, or incorporation of the mesh and graft into the host bone structure.
- As shown in
FIG. 2 , asingle mesh container 10 may have varying pore sizes, resulting in a differential porosity. That is, where the pores are larger, more fill material will flow out of the pores and where the pores are smaller less fill material will flow out of the pores. This differential porosity allows the surgeon to direct the flow of material out of the mesh pores and thus optimize the placement of the osteoinductive DBM more precisely to promote bony growth at the defect site. -
FIG. 3 shows apreferred tool 20, patented as U.S. Pat. No. 6,620,169 to Spineology, Inc, that may be used to process and inject the fill material mixture. In a preferred embodiment, thetool 20 shown inFIG. 3 is used to process the fill material mixture and inject the mixture into fill tubes.FIG. 4 shows the preferred embodiment where the fill material mixture is extruded from afill tube 30 having at least one opening to direct the flow of the fill material mixture into theporous container 10 for optimal fill material placement. - Additional components, for example, bone morphogenic protein, vascular endothelial growth factor, platelet derived growth factor, insulin-like growth factor, chondrocyte growth factor, fibroblast growth factor, antiviral agents, antibiotic agents and others may be added to the formulation.
Claims (11)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/924,240 US20050131417A1 (en) | 2003-08-22 | 2004-08-23 | Kit for treating bony defects |
US12/754,388 US8562613B2 (en) | 2003-08-22 | 2010-04-05 | Method kit for treating bony defects |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US49714603P | 2003-08-22 | 2003-08-22 | |
US10/924,240 US20050131417A1 (en) | 2003-08-22 | 2004-08-23 | Kit for treating bony defects |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/754,388 Division US8562613B2 (en) | 2003-08-22 | 2010-04-05 | Method kit for treating bony defects |
Publications (1)
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US20050261781A1 (en) * | 2004-04-15 | 2005-11-24 | Sennett Andrew R | Cement-directing orthopedic implants |
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US20070231788A1 (en) * | 2003-12-31 | 2007-10-04 | Keyvan Behnam | Method for In Vitro Assay of Demineralized Bone Matrix |
US20080027546A1 (en) * | 2006-07-25 | 2008-01-31 | Semler Eric J | Packed demineralized cancellous tissue forms for disc nucleus augmentation, restoration, or replacement and methods of implantation |
US20090087471A1 (en) * | 2007-06-15 | 2009-04-02 | Shimp Lawrence A | Method of treating tissue |
US20090130173A1 (en) * | 2007-06-15 | 2009-05-21 | Keyvan Behnam | Bone matrix compositions and methods |
US20090157087A1 (en) * | 2007-07-10 | 2009-06-18 | Guobao Wei | Delivery system attachment |
US20090155378A1 (en) * | 2003-12-31 | 2009-06-18 | Keyvan Behnam | Osteoinductive demineralized cancellous bone |
US20090220605A1 (en) * | 2007-06-15 | 2009-09-03 | Osteotech | Bone matrix compositions having nanoscale textured surfaces |
US20090226523A1 (en) * | 2007-10-19 | 2009-09-10 | Keyvan Behnam | Demineralized bone matrix compositions and methods |
US20090242081A1 (en) * | 2008-03-26 | 2009-10-01 | Richard Bauer | Aluminum Treatment Composition |
US20100049251A1 (en) * | 2008-03-28 | 2010-02-25 | Kuslich Stephen D | Method and device for interspinous process fusion |
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US20110004308A1 (en) * | 2009-06-17 | 2011-01-06 | Marino James F | Expanding intervertebral device and methods of use |
US7879103B2 (en) | 2005-04-15 | 2011-02-01 | Musculoskeletal Transplant Foundation | Vertebral disc repair |
US20110054532A1 (en) * | 2007-07-03 | 2011-03-03 | Alexandre De Moura | Interspinous mesh |
US20110054408A1 (en) * | 2007-07-10 | 2011-03-03 | Guobao Wei | Delivery systems, devices, tools, and methods of use |
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US20150297792A1 (en) * | 2006-08-31 | 2015-10-22 | Warsaw Orthopedic, Inc. | Demineralized cancellous strip dbm graft |
US9192397B2 (en) | 2006-12-15 | 2015-11-24 | Gmedelaware 2 Llc | Devices and methods for fracture reduction |
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US8911759B2 (en) | 2005-11-01 | 2014-12-16 | Warsaw Orthopedic, Inc. | Bone matrix compositions and methods |
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US20070110820A1 (en) * | 2005-11-01 | 2007-05-17 | Keyvan Behnam | Bone Matrix Compositions and Methods |
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US20150297792A1 (en) * | 2006-08-31 | 2015-10-22 | Warsaw Orthopedic, Inc. | Demineralized cancellous strip dbm graft |
US7909873B2 (en) | 2006-12-15 | 2011-03-22 | Soteira, Inc. | Delivery apparatus and methods for vertebrostenting |
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US9237916B2 (en) | 2006-12-15 | 2016-01-19 | Gmedeleware 2 Llc | Devices and methods for vertebrostenting |
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US20090087471A1 (en) * | 2007-06-15 | 2009-04-02 | Shimp Lawrence A | Method of treating tissue |
US9554920B2 (en) | 2007-06-15 | 2017-01-31 | Warsaw Orthopedic, Inc. | Bone matrix compositions having nanoscale textured surfaces |
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US20090242081A1 (en) * | 2008-03-26 | 2009-10-01 | Richard Bauer | Aluminum Treatment Composition |
US20100049251A1 (en) * | 2008-03-28 | 2010-02-25 | Kuslich Stephen D | Method and device for interspinous process fusion |
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