WO1998051240A1 - Temporary implantable prosthesis - Google Patents
Temporary implantable prosthesis Download PDFInfo
- Publication number
- WO1998051240A1 WO1998051240A1 PCT/US1998/009514 US9809514W WO9851240A1 WO 1998051240 A1 WO1998051240 A1 WO 1998051240A1 US 9809514 W US9809514 W US 9809514W WO 9851240 A1 WO9851240 A1 WO 9851240A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- mantle
- implantable prosthesis
- standardized
- temporary implantable
- implant
- Prior art date
Links
Classifications
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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
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1684—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the shoulder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1659—Surgical rasps, files, planes, or scrapers
-
- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1664—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the hip
- A61B17/1666—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the hip for the acetabulum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1664—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the hip
- A61B17/1668—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the hip for the upper femur
-
- 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
- A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
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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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- 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
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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
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4684—Trial or dummy prostheses
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- 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
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30205—Three-dimensional shapes conical
- A61F2002/30217—Three-dimensional shapes conical hollow cones, e.g. tubular-like cones
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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
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
- A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
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- 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
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30474—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using an intermediate sleeve interposed between both prosthetic parts to be coupled
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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
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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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
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- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
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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
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- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
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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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- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
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- A61F2002/3611—Heads or epiphyseal parts of femur
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- 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
- A61F2/32—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
- A61F2002/3625—Necks
- A61F2002/3631—Necks with an integral complete or partial peripheral collar or bearing shoulder at its base
-
- 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
- A61F2/32—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
- A61F2002/365—Connections of heads to necks
-
- 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
- A61F2002/4631—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor the prosthesis being specially adapted for being cemented
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0067—Three-dimensional shapes conical
-
- 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
- A61F2310/00952—Coating, pre-coating or prosthesis-covering structure made of bone cement, e.g. pre-applied PMMA cement mantle
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
- B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
- B29C43/04—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles using movable moulds
- B29C2043/043—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles using movable moulds rotating on their own axis without linear displacement
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
- B29C43/006—Pressing and sintering powders, granules or fibres
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7532—Artificial members, protheses
Definitions
- the invention provides a temporary implantable prosthesis which is used, for example, to replace a permanent prosthesis which has been removed from a patient's femur and acetabulum or humerus in order to treat a deep infection of a patient's joint.
- a significant amount of the tissue above the femur is cut and laid back to gain access to the femur.
- the surgeon removes the head from the femur, exposing the intramedullary canal.
- the surgeon subsequently broaches and/or mills the femur by inserting equipment into the canal.
- the surgeon then inserts the long stem and tapering body of the prosthesis into the enlarged intramedullary canal within the femur to anchor the prosthesis.
- the prosthesis does not seat properly and must be at least partially removed from the patient and reseated in the femur.
- An infectious agent can enter the area surrounding the joint during any of these steps.
- a patient who contracts an infection after a prosthesis is implanted must return to the hospital and have the prosthesis removed.
- the patient is treated with antibiotics orally or intravenously until the infectious agent is killed, which takes approximately eight weeks or more.
- the patient then returns to the hospital and has another prosthesis implanted.
- the patient's leg cannot support the patient or otherwise be used to help the patient move.
- the patient must use crutches or a walker for limited movements and, if the patient is bedridden, the patient can contract other diseases such as pneumonia during the months that the patient is confined to bed.
- the invention provides a temporary implantable prosthesis and an associated set of components used to construct a temporary implantable prosthesis.
- the temporary implantable prosthesis holds an antibiotic that is administered locally to kill an infection within the patient's bone.
- a temporary implantable prosthesis substitutes for a permanent prosthesis when it is necessary to remove the permanent prosthesis from a patient and, e.g., treat an infection of the patient's joint.
- a temporary implantable prosthesis has a mantle portion and an implant portion which are each sized and shaped such that the temporary implantable prosthesis can be used to replace any of a number of differently-sized and/or shaped permanent prostheses selected from a set of corresponding permanent prostheses.
- a temporary implantable prosthesis can be used to replace a permanent prosthesis to be removed from a first patient, or the same temporary implantable prosthesis can be used to replace at least one other, differently- shaped and/or sized permanent prosthesis in a different patient.
- a temporary implantable prosthesis comprises two parts, a standardized mantle and an implant.
- the standardized mantle is shaped to be placed within the cavity in the bone from which the permanent prosthesis was removed.
- the implant is a portion of the temporary implantable prosthesis which is embedded into or otherwise formed as part of the mantle, and which connects to the acetabulum or scapula to allow loads to pass from e.g. the pelvis and into the femur.
- the invention also provides a set of components for making temporary implantable prostheses.
- the components include standardized molds for casting the mantle, standardized implants, standardized broaches, a construction stand that holds a mold and implant to form a temporary implantable prosthesis, and standardized templates that correspond to the sizes and shapes of the mantles and the implants.
- a set of components can be, e.g., two or more individual components of different types (a standardized mold and a standardized implant, for example), or a set of components can be, e.g., two or more of the same type of component (two or more standardized molds, for example).
- a temporary implantable prosthesis comprised of a standardized mantle and a standardized implant is an inexpensive prosthesis which can be used to replace a permanent prosthesis within a patient's shoulder or hip and even to help treat an infection surrounding the joint site while providing the patient with the ability to move about during the period of time that the permanent prosthesis is removed from the patient.
- the patient is thus less susceptible to other opportunistic diseases such as pneumonia.
- Figure 1 illustrates one embodiment of a temporary implantable prosthesis, in which a standardized mantle 120 is formed about a standardized implant 110.
- the standardized implant has a taper 130, on which a standard head (not shown) is placed.
- Figures 2A-1 and 2A-2 show a side view and a rear view of a permanent cemented implant.
- Figure 2B-1 and 2B-2 show a rear and side view of a permanent cementless implant.
- Figures 3A and 3B illustrate two templates that correspond to the temporary standardized implant of Figure 1, which templates are placed over X-ray photographs of a patient's bone to assess fit of the temporary standardized implant within the intramedullary canal of the bone.
- Figure 4 shows a set of six broaches of different sizes, each of which corresponds to a temporary implantable prosthesis.
- Figure 5 illustrates a mold for casting differently-sized and/or shaped standardized mantles about an implant.
- Figure 6 illustrates a tapered sleeve which fits over a taper on a temporary implantable prosthesis. The tapered sleeve is used to provide different offsets to the head when it is placed over the tapered sleeve.
- Figures 7A and 7B show a head for placement over the tapered sleeve or for placement directly onto the taper of the temporary implantable prosthesis.
- the head has holes that allow antibiotic within cement packed into the hollow head to leach from the cement and to the site of infection.
- a temporary implantable prosthesis substitutes for a permanent prosthesis when it is necessary to remove the permanent prosthesis from a patient and, e.g., treat an infection of the patient's surrounding joint space.
- a temporary implantable prosthesis has a mantle portion and an implant portion wherein each portion is sized and shaped such that the temporary implantable prosthesis can be used to replace any of a number of differently-sized and/or shaped permanent prostheses selected from a set of corresponding permanent prostheses.
- the mantle portion fits within the cavity in the patient's femur or humerus from which the permanent prosthesis was removed.
- the mantle portion is shaped so that little bone has to be removed from the femur or humerus to accommodate the mantle portion, in order to preserve the structural strength and integrity of the patient's femur or humerus.
- the implant portion provides the proper length and offset to the temporary implantable prosthesis so that loads from e.g. the pelvis are transmitted through the implant portion and mantle portion and into the femur.
- the implant portion either has a head mounting location such as a taper where a unipolar or standard head can be placed, or the implant portion has a head that is formed as part of the implant portion.
- Both the mantle portion and the implant portion are also sized and shaped so that a temporary implantable prosthesis as illustrated in Figure 1 can be used to replace any permanent implant selected from a set of corresponding permanent implants.
- a set of corresponding permanent implants consists of at least two differently-sized and/or shaped permanent implants which are sufficiently similar to one another that a temporary implantable prosthesis can be designed to substitute for each of the permanent implants of the set.
- Figures 2A-1 and 2A-2 and Figures 2B-1 and 2B-2 illustrate two such permanent prostheses.
- the permanent implants of the set of corresponding implants have approximately the same length from the bottom of the mantle portion to the free end of the implant portion, approximately the same size and shape of their mantle portions, and approximately the same head offset as their corresponding temporary implantable prosthesis.
- a surgeon can use a temporary implantable prosthesis of a particular design to replace differently- sized and/or shaped permanent implants in different patients.
- a temporary implantable prosthesis and its mantle portion and implant portion can be designed using a number of methods. For example, dimensions and shapes of permanent prostheses are measured, and the permanent prostheses are separated into different sets according to how similar their shapes and overall dimensions are. The mantle portion and implant portion of the temporary implantable prosthesis are then designed so that one temporary implantable prosthesis can be used to replace each member of a set of corresponding permanent prostheses. Or, the designer may choose to place a limitation on the amount of bone that can be removed from a cavity based on the thickness of bone in the area, and the designer can follow the procedure of separating permanent prostheses and determining a best fit as discussed above when designing the temporary implantable prosthesis.
- a temporary implantable prosthesis and its mantle portion and implant portion can also be designed by examining X-rays of patients' femurs or humeri to determine dimensions and shapes of cavities and bone locations in patients who have received permanent implants, and then classifying the cavities into sets based on their similarity. The designer designs the mantle portion and the implant portion to provide the best fit based on such criteria as amount of bone removal required, amount of variation in length, width, depth, and shape that is acceptable, and like criteria.
- a temporary implantable prosthesis can be designed by determining the dimensions and shapes of mantle portions and implant portions of sets of permanent implants and providing components that are sufficiently close in dimension and shape to the mantle portions and implant portions that a temporary implantable prosthesis constructed from the components will substitute for any member of a set of permanent implants.
- a temporary implantable prosthesis may be one solid component or separate components that fit together to form a temporary implantable prosthesis.
- a temporary implantable prosthesis comprises two components, a standardized mantle and an implant.
- a standardized mantle has a size and shape such that the standardized mantle can be used in place of the mantle or body and stem portion of a permanent prosthesis to be removed from a patient. Further, the standardized mantle has a size and shape that is sufficiently similar to the size and shape of mantle portions of a number of different prostheses that the standardized mantle can be used in patients from which any of the permanent prostheses of the set have been removed.
- Figures 2A-1 and 2A-2 and Figures 2B-1 and 2B-2 illustrate two permanent prostheses and their mantle portions.
- Figures 2A-1 and 2A-2 show a permanent cemented implant 200 having mantle portion 210 and implant 220
- Figure 2B shows a permanent cementless implant having mantle portion 260.
- the mantle portions of those prostheses are the portions which are inserted into the cavity broached or milled in the patient's femur or humerus and which transmit much of the load carried by the prosthesis into the surrounding bone.
- the standardized mantle may require removal of a small amount of bone to prepare the femoral cavity to accept the standardized mantle, but the standardized mantle does not require removal of so much bone that the bone is substantially weakened to where fracture is likely when the subsequent permanent prosthesis is inserted and used by the patient.
- a standardized mantle can be used in place of its corresponding set of prostheses so that a variety of patients can be treated using a single shape.
- the implant can be a custom or standard implant, for example, which is designed for a particular patient or for use in standard, permanent prostheses.
- a custom implant may be necessary to obtain a good fit to a particular patient or where a permanent prosthesis must be removed from a patient quickly and the custom implant is the only one available.
- the implant is a standardized implant.
- a standardized implant has a shape and size which allows it to substitute for the portion of the patient's permanent implant above the mantle portion of the implant.
- the standardized implant has a size and shape such that the standardized implant cooperates with the standardized mantle to provide a temporary implantable prosthesis that can be used in place of the permanent implant or prosthesis to be removed from a patient, and so that the assembled temporary implantable prosthesis has the necessary strength to allow the patient to move about e.g. on crutches or even on foot.
- a temporary implantable prosthesis comprising a standardized mantle and a standardized implant can be used to replace a number of custom or standard designs of permanent prostheses when patients develop an infection in the vicinity of their permanent prostheses.
- a temporary implantable prosthesis is placed in a patient temporarily, until a time that the patient can accept a subsequent permanent implant. Because a temporary implantable prosthesis is used temporarily within a patient, the temporary implantable prosthesis and/or the standardized implant and standardized mantle can each be designed to be simple pieces that require little machining or few steps to assemble. A temporary implantable prosthesis is thus easy to make, easy to insert, and easy to remove from a patient. Because the temporary implantable prosthesis and its components are less complex than an implant used in a custom prosthesis, a temporary implantable prosthesis is an inexpensive assembly.
- a temporary implantable prosthesis can be made by many methods.
- a temporary implantable prosthesis or at least one of the components used to form a temporary implantable prosthesis can be machined from solid materials such as metal and/or plastic, or a temporary implantable prosthesis or at least one of the components used to form a temporary implantable prosthesis can be made by casting e.g. a metal or plastic in a mold.
- Sets of components can be supplied to a surgeon to assemble during surgery, or a set of components and other pieces can be supplied to a surgeon so that the surgeon can construct a temporary implantable prosthesis during or prior to surgery.
- One set of components and pieces to make a temporary implantable prosthesis includes a mold having six cavities of different sizes and/or shapes for making standardized mantles, a set of six standardized broaches whose shapes correspond to the shapes of the standardized mantles that are made in the standardized molds, a set of six standardized implants, type and trial unipolar heads of various diameters, four tapered sleeves of various sizes to obtain proper head offset, a construction stand that holds a mold and implant to form a temporary implantable prosthesis, and a set of standardized implant/mantle templates that correspond to the sizes and shapes of the implants and the various mantles that can be formed.
- the X-ray is performed at a standard distance from the top of the patient's femur in order to obtain a standard scale of dimensions on the X-ray photograph of the femur, the permanent prosthesis, the pelvis, and how the femur aligns with the pelvis.
- the surgeon selects templates of an implant/mantle profile 300 of Figures 3A and 3B from a temporary implantable prosthesis kit. Two templates as illustrated in Figures 3A and 3B correspond to one temporary implantable prosthesis that is made using the kit.
- One template 3 10 provides an anterior-posterior view of the temporary implantable prosthesis, and one template 320 provides the medial-lateral view of the temporary implantable prosthesis.
- the two templates are produced to essentially the same scale as the X-ray photographs, so that the surgeon can lay the templates onto the X-ray photograph in order to find a temporary implantable prosthesis with the best fit to the patient's femur.
- the surgeon determines which standardized mantle has the most appropriate size and shape to replace the permanent prosthesis fitted to the patient. The surgeon decides whether the standardized mantle will fit within the existing cavity or whether it is necessary to broach the cavity further using the standardized broach that corresponds to the standardized mantle that the surgeon has chosen.
- the surgeon selects the broach which corresponds to the templates that the surgeon determined best fit the patient's femur.
- the permanent implant is removed from the patient's infected femur, and the intramedullary canal is debrided of all necrotic tissue and cement.
- the acetabular component is also removed and all necrotic tissue is debrided.
- the broach is then inserted into the canal and seated.
- the position that the broach assumes with respect to the femur demonstrates if the correct broach size has been chosen. If the broach size is incorrect, the broach is removed and a different broach is inserted into the canal and seated.
- the surgeon also has the opportunity to place the head on the broach and assess the anteversion angle that is needed. Once the correct broach size and appropriate anteversion angle are determined, the surgeon can construct the temporary implantable prosthesis.
- the components involved in constructing the temporary implantable prosthesis are sterilized.
- the two halves 510 and 520 of mold 500 are secured together with four threaded hand knobs 530.
- the assembled mold has six cavities which correspond to the six standardized mantle portions that this assembly kit makes.
- the mold 500 is then placed in the base 540 to hold the mold upright.
- Cement precursor and an optional antibiotic are mixed in a separate container to form a mantle mixture, and a measured amount is poured into the mold cavity which corresponds to the broach selected above.
- the mantle mixture is a blend of cement precursor (commonly polymethylmethacrylate powder and a liquid monomer such as methyl methacrylate) and, optionally, an antibiotic such as tobramycin.
- the implant is inserted into the mold, and the proper anteversion angle is set by simply rotating the standardized implant about its long axis in the mold.
- the mold and implant are designed so that the implant is centered in the mold by its close fit distally with the mold.
- This preferred embodiment of the invention includes a slight taper on the distal end of the temporary implant and the corresponding female taper in the mold. These features allow the implant to seat with the mold and center the implant.
- the mantle mixture hardens around the standardized implant to form the standardized mantle portion and the temporary implantable prosthesis.
- the mantle is molded around the implant prior to insertion into the femur, which allows the temporary implantable prosthesis to be removed easily from the femur at a later date.
- the two halves of the mold are subsequently separated by releasing the four threaded knobs, and four Allen-drive set screws are used to push the two halves of the molds apart.
- the temporary implantable prosthesis can then be removed from the mold.
- the temporary implantable prosthesis is next inserted and seated into the femur. If necessary, the surgeon uses the broach corresponding to this temporary implantable prosthesis to remove more of the femur to provide the correct fit. Heads can be trialed next by placing a tapered sleeve 600 of Figure 6 over the taper 130 of the temporary implantable prosthesis and fitting one of the trial plastic heads supplied with the kit.
- the tapered sleeve is selected from a set of e.g. four tapered sleeves of different offset (+0, +5, +10, and +
- the correct diameter of head is selected from a set of e.g. four heads (48 mm, 53 nun, 58 mm, and 63 mm diameter) by fitting a plastic head over a tapered sleeve placed on the taper of the temporary implantable prosthesis and placing the plastic head into the acetabulurn and noting its fit.
- the plastic head is removed, and a metal unipolar head of the correct diameter is placed over the tapered sleeve on the taper of the temporary implantable prosthesis.
- the head is cemented to the tapered sleeve and taper, and the patient's joint is reduced.
- the head and taper have a Morse taper which joins the head and taper together without cement. Proper range of movement of the patient's leg is checked, and the closing procedure is performed.
- Figures 7 A and 7B illustrate a particular design of head that assists in curing the infection of the patient's joint.
- the head is not solid but is, instead, hollow.
- Mantle mixture that includes antibiotic is permitted to harden slightly and is packed into the hollow head. Holes in the head allow the antibiotic to diffuse into the acetabulurn. Holes are sized to permit diffusion of antibiotic from the head and into the acetabulurn. The holes are not so large as to weaken the head and allow it to fracture during use.
- the cement When antibiotic is incorporated into the mantle mixture, the cement is of sufficient porosity that at least some of the antibiotic incorporated into the cement migrates out of the cement and to the infected joint. The joint is thus treated directly with an antibiotic from the cement.
- the patient may also receive an antibiotic orally or intravenously to maintain a certain level of antibiotic in the patient to treat the infection, especially once the temporary implantable prosthesis has been within the patient for a few weeks.
- the patient can move about more easily and with greater comfort when the patient has a temporary implantable prosthesis of this invention.
- the patient is thus less susceptible to pneumonia and other opportunistic diseases that could develop if the patient did not have the freedom of movement that the temporary implantable prosthesis helps to provide.
- standardized molds and standardized implants are used to make a temporary implantable prosthesis in one embodiment of the invention. Since a temporary implantable prosthesis is used temporarily, the temporary implantable prosthesis does not have to fit perfectly within the femur. The temporary implantable prosthesis needs to fit only sufficiently well that the patient has the ability to move about with crutches or a cane or walker.
- a standardized mold can be sized and shaped based on e.g.
- a temporary implantable prosthesis or a standardized mantle as discussed previously, or on the designer's perceptions of the various sizes and shapes of cavities in patients' femurs.
- the designer can obtain information on the conurion sizes and shapes of permanent prostheses and perform a statistical analysis to determine standardized sizes and shapes of the mantle and implant.
- the designer then designs the standardized molds, the standardized broaches, and the standardized implants.
- standardized molds can be sized and shaped based on a particular supplier's product line, so that the molds supply mantles of approximately the same size and shape as the mantles of the manufacturer's permanent prostheses.
- standardized molds can be designed to provide standardized mantles which have been designed using any of the methods discussed in this application.
- a standardized mold can be designed so that the standardized mantle is of the correct length and shape when the standardized mold is filled with mantle material.
- the size and shape of the standardized broaches is determined from the size and shape of the standardized mantles to be made in the standardized molds.
- the embodiment of the invention as described above is one of many embodiments of the invention. Many other embodiments are possible.
- the mantle of the temporary implantable prosthesis can be coated with antibiotic, or the antibiotic can be eliminated.
- Standardized implants can be designed to have a single diameter or oblong profile and a single set of dimensions for their head mounting location (e.g. taper).
- the length of the implant and the angle that the head mounting location makes to the shaft of the implant are selected by the designer based on the designer's perceptions of the dimensions needed to cooperate with the standardized mantles and provide temporary implantable prostheses of the desired dimensions.
- statistical information can be used to design a set of standardized implants that will provide a large portion of the populace with a functional temporary implantable prosthesis.
- the head that attaches to the head mounting location can be a unipolar head in order to simplify the design of the temporary implantable prosthesis.
- a unipolar head contacts the acetabulurn, just as the head on the femur does.
- the unipolar head preferably has holes drilled into the head radially to allow antibiotic to diffuse through the holes and into the joint space cavity, once the antibiotic and cement have been packed into the backside of the head.
- a unipolar head is widely available, and use of a unipolar head provides the surgeon with a wide variety of options in size of head and offset when fitting the temporary implantable prosthesis to the patient.
- the mold cavities and the distal end of the standardized implant are preferably non-cylindrical in cross-section to help prevent the implant from rotating within its mantle during use.
- the distal end of the standardized implant and mold cavities could be cylindrical in design. This would allow the standardized implant to be centered in the cavity and would allow axial adjustment of the implant. This design feature would give the surgeon flexibility to position the standardized implant in the mold to provide more vertical offset if needed.
- a readilyavailable implant may be inserted into a standardized mold of this invention to form a temporary implantable prosthesis. It is also not necessary to insert the implant into the cavity in the mold prior to inserting the mantle mixture.
- the mantle mixture can be placed into the cavity first, and the mantle mixture may also be permitted to polymerize substantially prior to placing the insert into the mantle mixture.
- the mold can be a split mold as illustrated in Figure 1 , or the mold can be a solid, smooth mold having a cavity in which the mantle is cast.
- the head may be offset from the centerline of the taper in order to provide the patient with a more comfortable prosthesis. Also, instead of using a unipolar head, the surgeon may choose to use a head which contacts a plastic cup that is inserted into the acetabulurn in order to provide better comfort.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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AU72953/98A AU7295398A (en) | 1997-05-15 | 1998-05-12 | Temporary implantable prosthesis |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US85695197A | 1997-05-15 | 1997-05-15 | |
US08/856,951 | 1997-05-15 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1998051240A1 true WO1998051240A1 (en) | 1998-11-19 |
Family
ID=25324839
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/009514 WO1998051240A1 (en) | 1997-05-15 | 1998-05-12 | Temporary implantable prosthesis |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU7295398A (en) |
WO (1) | WO1998051240A1 (en) |
Cited By (14)
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WO2002043625A1 (en) * | 2000-12-01 | 2002-06-06 | Depuy International Limited | A template for a modular joint prosthesis component |
EP2052700A1 (en) * | 2007-09-26 | 2009-04-29 | Microchips, Inc. | Drug delivery device and method for use with prosthetic device implantation |
WO2009076168A1 (en) * | 2007-12-13 | 2009-06-18 | Biomet Manufacturing Corp. | Modular articulating cement spacer mold |
FR2925842A1 (en) * | 2008-01-02 | 2009-07-03 | Ceram Concept France Sarl Sarl | Modular above-knee prosthesis elements assembly for supporting patient's thigh bone, has passage receiving threaded tool to withdraw prosthesis after withdrawing cones, where each cone is different from other cones by longitudinal dimension |
WO2010050995A1 (en) * | 2008-10-29 | 2010-05-06 | Zimmer Orthopaedic Surgical Products, Inc. | Spacer molds with releasable securement |
US7789646B2 (en) | 2007-12-07 | 2010-09-07 | Zimmer Orthopaedic Surgical Products, Inc. | Spacer mold and methods therefor |
WO2010096559A3 (en) * | 2009-02-20 | 2010-11-04 | Biomet Manufacturing Corp. | Modular articulating cement spacer |
FR2961684A1 (en) * | 2010-06-25 | 2011-12-30 | T O | Femoral shaft preparation and surgical instrument assembly for implantation of femoral rod, has receiving cavity worked by smoothing rasp including section corresponding to shape and dimension of chosen size of femoral rod |
US8480289B2 (en) | 2008-08-22 | 2013-07-09 | Biomet Manufacturing, Llc | Bone cement mixing cartridge and method of use |
DE102012000685A1 (en) | 2012-01-17 | 2013-07-18 | Heraeus Medical Gmbh | Process for the preparation of a spacer and a mold for the production of a spacer |
US8900620B2 (en) | 2005-10-13 | 2014-12-02 | DePuy Synthes Products, LLC | Drug-impregnated encasement |
EP2853242A1 (en) * | 2013-09-27 | 2015-04-01 | Heraeus Medical GmbH | Modular articulated spacer system |
US9381683B2 (en) | 2011-12-28 | 2016-07-05 | DePuy Synthes Products, Inc. | Films and methods of manufacture |
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US5665121A (en) * | 1992-02-03 | 1997-09-09 | Howmedica International | Preformed mantle |
US5443523A (en) * | 1994-03-18 | 1995-08-22 | Mikhail; W. E. Michael | Femoral stem cement mantle |
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JP2012507343A (en) * | 2008-10-29 | 2012-03-29 | ジンマー オーソピーディック サージカル プロダクツ,インコーポレーテッド | Spacer mold with releasable fixing structure |
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FR2961684A1 (en) * | 2010-06-25 | 2011-12-30 | T O | Femoral shaft preparation and surgical instrument assembly for implantation of femoral rod, has receiving cavity worked by smoothing rasp including section corresponding to shape and dimension of chosen size of femoral rod |
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