WO2003013388A2 - Apparatus for replacing musculo-skeletal parts - Google Patents
Apparatus for replacing musculo-skeletal parts Download PDFInfo
- Publication number
- WO2003013388A2 WO2003013388A2 PCT/US2002/023890 US0223890W WO03013388A2 WO 2003013388 A2 WO2003013388 A2 WO 2003013388A2 US 0223890 W US0223890 W US 0223890W WO 03013388 A2 WO03013388 A2 WO 03013388A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- prosthetic implant
- recited
- comprised
- heat
- porous
- Prior art date
Links
- 0 CC1*CCC1 Chemical compound CC1*CCC1 0.000 description 1
- GPKPUASWIHWYIQ-ZETCQYMHSA-N C[C@@H]1CC2(CC2)CC1 Chemical compound C[C@@H]1CC2(CC2)CC1 GPKPUASWIHWYIQ-ZETCQYMHSA-N 0.000 description 1
Classifications
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
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- A—HUMAN NECESSITIES
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- 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
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
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- A—HUMAN NECESSITIES
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- 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
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3662—Femoral shafts
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- A—HUMAN NECESSITIES
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- 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
- A61F2/30721—Accessories
- A61F2/30724—Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
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- A—HUMAN NECESSITIES
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- 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
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- 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
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- 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
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61F2002/30039—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 shape-memory transition temperatures, e.g. in martensitic transition temperature or in austenitic transition temperature
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- A—HUMAN NECESSITIES
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- 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
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
- A61F2002/30064—Coating or prosthesis-covering structure made of biodegradable material
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- 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
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- 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
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00155—Gold or Au-based alloys
-
- 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
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00574—Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon
- A61F2310/0058—Coating made of diamond or of diamond-like carbon DLC
-
- 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
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
-
- 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
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
-
- 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
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
- A61F2310/00988—Coating made of fibrin
Definitions
- An artificial prosthetic device comprised of a stem integrally connected to a neck portion, a head connected to the stem, and two porous tubes disposed about the stem.
- the hip joint is called a ball-and-socket joint because the spherical head of the thighbone (femur) moves inside the cup-shaped hollow socket (acetabulum) of the pelvis, hi a properly functioning hip joint, a series of motions, such as flexion, extension, abduction and adduction, can be carried out to utmost capabilities without stress, strain or pain involved in the motions.
- hip replacement surgery is performed to alleviate the symptoms and replace the affected parts.
- Implants may be used in hip arthroplasty, total knee replacements, and prosthetic limbs.
- Hip prosthetics have a success rate of ninety percent for about twenty years, taking into account revision surgery.
- a total hip replacement prosthetic implant must have three parts: the stem, which fits into the femur and provides stability; the ball, which replaces the spherical head of the femur and the acetabular cup, which replaces the worn-out hip socket. Each part comes in various sizes in order to accommodate various body sizes and types.
- Agrawal et al. provided a metallic press fit prosthetic device comprising at least one porous tissue mating surface on the metallic press fit prosthetic device having interstitial spaces impregnated with a polymer selected from a group consisting of polylactic acid (PLA), polyglutamic acid (PGA), and PLA-PGA copolymers.
- the polymer contains a pharmacologically active substance whose release is controlled over a therapeutically effective period of time.
- a prosthetic implant comprised of a stem integrally connected to a neck, a head that sits on top said neck, and porous assembly disposed around the stem.
- the porous assembly is comprised of a first porous tube and a second porous tube, wherein the second porous tube is disposed within the first porous tube, and wherein the stem is disposed within the second porous tube.
- the porous assembly is a heat absorbent porous assembly, which tends to maintain its temperature within a specified range.
- the head is comprised of means for releasing a material over a specified period of time.
- Figure 1 is a schematic view of the implantable prosthesis of this invention
- Figure 2 is a schematic view of the head of the implantable prosthesis of this invention; (also the release of lubrication)
- Figure 3 is a sectional view of the head of the prosthesis of Figure 2;
- Figure 4 is a sectional view of the stem of the prosthesis of Figure 1. Best Mode for Carrying Out the Invention
- the invention relates to an implantable prosthesis, and in one embodiment, to a bone prosthesis that is attached to the bone and that provides improved methods for monitoring and responding to problems associated with the prosthesis in vivo.
- the prosthesis of this invention responds to changes in its characteristics and its environment, as would the biological element it is replacing.
- FIG. 1 is a schematic view of an implantable prosthesis 10 which, in the embodiment depicted, is a structure in the shape of femur but can also take the shape of a humerus, ulna, radius, and the like.
- the prosthesis 10 is properly referred to as a femoral implant. Reference may be had, e.g., to
- femoral implant 10 is preferably an integral structure comprised of a stem section 12 and a neck section 14.
- the prosthesis 10 comprises a heat absorbent body 22.
- heat absorbent body 22 is comprised of two metal alloys 18 which are joined together and which differ from each other in their material compositions and the heat absorbency.
- the heat absorbent body 22 is capable of utilizing body heat to change one or more of its physical properties, such as its size and shape; and it additionally is capable of reverting to its original physical property, with the release of heat, when the ambient temperature to which it is exposed drops.
- the heat absorbent body is capable of reverting to its original size and shape when the temperature of the organism in which it is disposed drops.
- heat is first transformed into mechanical motion and is not transferred to the biological organism; and, thereafter, when the ambient temperature drops, heat then released to the biological organism while the material reverts to its original size and shape.
- heat absorbent The ability of body 22 to change its shape upon being subjected to a temperature within a certain specified range is what is referred to as "heat absorbent" in this specification.
- heat absorbent alloy materials that may be made into articles which can be deformed from their original shape in to a different configuration that it heat unstable, i.e., that reverts to its original configuration upon the application of heat.
- the heat absorbent body 22 may be manufactured from spring steel or from alloys exhibiting super-elastic or shape memory properties. Articles manufactured from such alloys may be deformed from their original shape into a different configuration that is heat unstable, and upon the application of heat will revert to the original configuration.
- certain shape memory alloys including super-elastic nickel-titanium (NiTi) (nitinol) or copper-zinc- aluminum (CuZnAl) alloys that are well known in the art, can be deformed through the application of stress to the article of manufacture and will revert to their original shape upon removal of the stress in a phenomenon generally referred to as stress induced martensite (SIM), thereby eliminating the need for alternately cooling and heating the article.
- SIM stress induced martensite
- SLM shape memory alloys that are stressed at temperatures between where the alloy first begins to transform from austenite to martensite, and the maximum temperature at which martensite can occur, deform elastically up to a critical stress and then continue to deform through the formation of SLM.
- a SIM shape memory alloy be one that reverts back to austenite at the typical human body temperature of about 36.70 degrees Celsius.
- heat absorbent materials have been described in this specification. What they all have in common is that, at a specified temperature within the range from about 36 to about 38 degrees Centigrade, the material absorbs heat and changes at least one of its physical properties, such as its shape and/or the phase of one or more of its components. Additionally, when the ambient temperature drops below the aforementioned specified temperature within the range of from about 36 to about 38 degrees Centigrade, the material gives up heat and returns to its original physical state. Thus, the material tends to maintain the temperature area surrounding it at about the specified change temperature within the range of from about 36 to about 38 degrees Centigrade.
- the aforementioned materials of the Boyle patent will tend to maintain a substantially constant temperature by absorbing heat above about 36.7 degrees Centigrade (and changing phase) and releasing heat below about 36.7 degrees Centigrade and reverting to its original phase.
- this material tends to maintain the biological organism within which it is disposed within the narrow range of temperatures, which sustain life.
- the joined body is located at the bottom of the stem 12 and may be constructed of a wear resistant titanium biocompatible alloy, as disclosed in United States patent 3,643,658 of Steinmann, of which the entire disclosure is hereby incorporated by reference into this specification.
- metal alloys 18 include biocompatible forms of copper-tin, copper-zinc, copper-zinc-tin, copper-zinc-xenon, copper- aluminum-nickel, copper-gold-zinc, gold-cadmium, gold-copper-zinc, iron beryllium (Fe 3 Be), iron platinum (Fe Pt), indium-thallium, iron-manganese, iron-nickel-titanium-cobalt, nickel- titanium-vanadium, and silver-cadmium.
- the shape memory alloy 22 which comprises the heat-absorbing material has a heat capacity of 320 Joules per Kilogram-degree Celsius and a thermal conductivity of 600 Joules per meter-minute degree Celsius at high and low temperature phases.
- the integral stress bearing region comprised of alloy 18, joined to the absorbent body 22, will consist of pores 21 at the distal end of its stem to act as a means for increasing the anchorage of prosthesis 10, permitting in-growth of bone into the prosthesis 10.
- the prosthetic implant will have a coating (not shown) on the entire length of the prosthetic implant 10.
- the coating (not shown) will be disposed on the portion (not shown) of the acetabular cup (not shown) in contact with living tissue.
- the coating is combined from cultured human marrow stromal fibroblasts (MSFs) with hydroxyapatite/tri-calcium phosphate.
- the composition may further comprise fibrin glue.
- the fibrin glue is derived from human fibrinogen when implanted into a human.
- human fibrinogen is preferable for implantation of human MSFs into humans because such fibrinogen can be easily isolated from blood of the individual undergoing implantation and will not induce an autoimmune reaction.
- MSFs are derived from human bone c o aspirates.
- from about 1x10 to 1x10 MSFs are loaded per 10 to 100 mg of delivery vehicle, which in this case is stem 12.
- the hydroxyapatite/tri-calcium phosphate (HA/TCP) powder is washed with culture medium prior to combining with the MSF cell suspensions. After mixing, the MSFs-HA/TCP is incubated with rotation at about 37° C. for 40 to 90 minutes.
- fibrinogen is added to the MSF-loaded
- HA/TCP followed by thrombin.
- the resulting fibrin serves as a "glue” to hold the HA/TCP particles together.
- the prosthetic implant 10 will have longitudinal pocket (not shown in Figure 1, but see Figure 4) ninning the length of the stem 12 between the core material 22 and the tubes 24/26.
- heat absorbent body 22 is disposed, at least in part, within a tube 24 which encloses such body 22.
- the material which comprises body 22 is preferably in a particulate form; and thus a tube 24 and a tube 26 is necessary to enclose it and to give it a defined shape.
- tube 24 be made from a flexible, biocompatible material that is adapted to release a pharmacologically active material.
- the tube 24 is made from one or more of the polymers disclosed in United States patent 5, 876,466 of Agrawal et al., the entire disclosure of which is hereby incorporated by reference into this specification.
- These polymer materials may include, e.g., polylactic acid (PLA), poly (gamma-glutamic) acid (PGA), and PLA — PGA copolymers.
- PVA polylactic acid
- PGA poly (gamma-glutamic) acid
- PLA — PGA copolymers e.g., polylactic acid (PLA), poly (gamma-glutamic) acid (PGA), and PLA — PGA copolymers.
- PLA polylactic acid
- PGA poly (gamma-glutamic) acid
- the pharmacologically active substance may be an antibiotic.
- the active substance may be: (1) an anti-infective agent, such as antibiotics, including penicillin, tetracycline, chlortetracycline bacitracin, nystatin, streptomycin, neomycin, polymyxin, gramicidin, oxytetracycline, chloramphenicol, and erythromycin; sulfonamides, including sulfacetamide, sulfamethazine, sulfadiazine, sulfamerazine, sulfamethizole and sulfisoxazole; antiviral, including idoxuridine; and other anti-infective including nitrofurazone and sodium propionate; (2) an anti-allergenic agent, such as antazoline, methapyrilene, chlorpheniramine, pyrilamine and prophenpyridamine; (3) an anti-
- tube 24 acts as one drug delivery system in the prosthesis 10 of the invention.
- Tube 26 may delivery the same agent as tube 24 at the same rate, and/or it may deliver one or more different agent(s) at one or more different rates.
- the prosthetic implant 10 will have porous tubes 24 and 26 along its stem 12 for the timed release of antibiotic and anti-inflammatory drugs, fibroblast, osteoblast and morphogens; these and other agents are described in United States patent number 5,453,235 of Calcote et al, the entire disclosure of which is hereby incorporated by reference into this specification.
- a dual porosity polytetrafluoroethylene (PTFE) tube 24 and 26 including an inner surface of expanded PTFE material in tubular form having a first porosity and an outer surface of expanded PTFE material in tubular form having porosity different from that of the first surface.
- PTFE polytetrafluoroethylene
- the porosity of the inner surface and the porosity of the outer surface are both within a range of about 0.01-200 microns.
- the preferred method of making a dual porosity PTFE tube includes the step of forming an inner preformed tubular billet and an outer preformed tubular billet; the outer billet is adapted to closely fit concentrically within the inner billet. Porosity of the inner and outer surfaces is varied within a range of about 0.1 — 150 microns by changing, in the respective billet, the lubrication level and/or PTFE resin particle size.
- the preferred fluoropolymer, PTFE is chosen due to its low coefficient of friction, but is by no means limited to it.
- the inner surface of the PTFE tube is made less porous to reduce blood leakage, while the outer surface is made more porous to enhance tissue in-growth.
- the aforementioned porosity is reversed, that is, the inner surface is made more porous while the outer surface is made less porous, to accelerate healing of bone into the prosthetic implant.
- the method for protecting mammalian tissue from damage associated with an inflammatory response following a tissue injury is as described in United States patent number 6,194,376 by Kuberasampath et al, the entire disclosure of which is hereby incorporated by reference into this specification.
- the method of this patent makes use of osteogenic protein 1 (OP-1), which is known by those skilled in the art as a tissue morphogens.
- OP-1 osteogenic protein 1
- the absorbent body 22 has invaginations 42 of depth not exceeding fifty percent of the cross-sectional area of the implant 10.
- the aforementioned invaginations 42 contain nanoporous biocompatible membrane in the shape of a sac. Such membrane contains time releases drugs.
- nanoporous biocompatible membrane described by the World organization patent number 9,855, 101 Al.
- the biocompatible nanoporous membrane disclosed in the aforementioned World organization patent number 9,855, 101A1 enables sustained delivery of drugs over weeks to months.
- the controlled pore size of the membrane can be as small as 1 nanometer up to more than 250 nanometers, with over 100 million pores per square centimeter and a thickness of 100 micro-meters.
- the drug can be delivered from an implantable system over several weeks to several months.
- the delivery profile can be tailored to specific pharmacokinetic requirements by modification of the size as well as the thickness of the membrane. Additional surface chemistry can be added to the membrane in order to delay the delivery over a prolonged period of time.
- the number of pores can be as high as one billion pores per square centimeter.
- the thickness of the membrane can be between 50 nanometers and several hundreds of micrometers.
- the head 30 of the prosthetic implant is configured in such a manner that such head 30 consists of solid circular shaped objects 32, a load bearing spring system 38, a circular shaped shell enclosing the entire system 34 comprising said bearing system 38.
- the solid circular shaped objects 32 which might be in contact with a naturally occurring surface within the body (such as, e.g., calcified bone), will have a preferred coating of diamond-like carbon disposed on them.
- a naturally occurring surface within the body such as, e.g., calcified bone
- the elements of the joint wear against each other and the impact and friction forces eventually cause pieces if the load bearing surfaces to spall and float above the joint.
- This debris initiates a hystiocytic reaction in which the body's immune system is activated and releases enzymes to dissolve the particles.
- the enzymes usually fail to dissolve the debris, or take a considerable amount of time to do so. To further complicate matters, the enzymes react with the bone supporting the prosthetic joint. The enzymes weaken or dissolve the bone.
- the method also comprises the step of polishing the diamond layer to an RA value of between 0.1 and 0.010 microns to a high luster to provide the diamond layer a low coefficient of friction.
- the coating material of the circular shaped shell enclosing the entire system 34 is either polycrystalline diamond compact or some form of biocompatible titanium alloy, as is described in United States patent number 6,010,533 by Pope et al.
- the circular solid objects 32 act as a buffer between a lubrication liquid and the acetabular component or the naturally occurring surface within the body it's in contact with (see Figure 3).
- the lubrication dispensed within the cavity of the circular shaped shell 36 can be of a saline solution, such as phosphate buffered solution, ringers solution (which contains sodium chloride, potassium chloride, calcium chloride, sodium bicarbonate and glucose in the concentrations in which they occur in body fluids) and phosphohpids.
- a saline solution such as phosphate buffered solution, ringers solution (which contains sodium chloride, potassium chloride, calcium chloride, sodium bicarbonate and glucose in the concentrations in which they occur in body fluids) and phosphohpids.
- phosphohpids include those as described in United States patent number 6,133,249 by Hills et al. The patent provides phosphohpids and propylene glycol based lubricants to be administered to physiological joints, articulations and prosthetic or partly prosthetic joints.
- the composition comprises between about 25 milligrams to about 500 milligrams of phosphohpids per 1 milliliter of propylene glycol administered at a volume of between 0.1 milliliter to about 10 milliliters.
- One or more of the phosphohpids are selected from a group consisting of shingolipids, phosphogrycerides, phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidylglycerol, phosphatidylinositol, sphingomyelin and derivatives thereof which are suitable in lubricant compositions where in said phosphohpids is a alpha- dipalmitoyl phosphatidylcholine, racemic alpha-dipalmitoyl phosphatidylcholine or a L- enantiomeric alpha-dipalmitoyl phosphatidylcholine.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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AU2002322704A AU2002322704A1 (en) | 2001-07-30 | 2002-07-29 | Apparatus for replacing musculo-skeletal parts |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US09/918,068 US6494916B1 (en) | 2001-07-30 | 2001-07-30 | Apparatus for replacing musculo-skeletal parts |
US09/918,068 | 2001-07-30 |
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WO2003013388A2 true WO2003013388A2 (en) | 2003-02-20 |
WO2003013388A3 WO2003013388A3 (en) | 2003-12-11 |
WO2003013388A9 WO2003013388A9 (en) | 2004-04-29 |
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PCT/US2002/023890 WO2003013388A2 (en) | 2001-07-30 | 2002-07-29 | Apparatus for replacing musculo-skeletal parts |
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US (2) | US6494916B1 (en) |
AU (1) | AU2002322704A1 (en) |
WO (1) | WO2003013388A2 (en) |
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2002
- 2002-07-29 AU AU2002322704A patent/AU2002322704A1/en not_active Abandoned
- 2002-07-29 WO PCT/US2002/023890 patent/WO2003013388A2/en not_active Application Discontinuation
- 2002-12-13 US US10/318,799 patent/US20030130742A1/en not_active Abandoned
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US5507814A (en) * | 1994-03-30 | 1996-04-16 | Northwestern University | Orthopedic implant with self-reinforced mantle |
Also Published As
Publication number | Publication date |
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WO2003013388A9 (en) | 2004-04-29 |
US6494916B1 (en) | 2002-12-17 |
US20030130742A1 (en) | 2003-07-10 |
AU2002322704A1 (en) | 2003-02-24 |
WO2003013388A3 (en) | 2003-12-11 |
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