WO1995013757A1 - Prothese modulaire a elements d'alliage a memoire de forme - Google Patents
Prothese modulaire a elements d'alliage a memoire de forme Download PDFInfo
- Publication number
- WO1995013757A1 WO1995013757A1 PCT/US1994/012943 US9412943W WO9513757A1 WO 1995013757 A1 WO1995013757 A1 WO 1995013757A1 US 9412943 W US9412943 W US 9412943W WO 9513757 A1 WO9513757 A1 WO 9513757A1
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- WIPO (PCT)
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- section
- prosthesis
- sections
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- disposed
- Prior art date
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Classifications
-
- 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
- A61F2/34—Acetabular cups
-
- 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
- A61F2/30721—Accessories
- A61F2/30724—Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving 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
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
-
- 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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
-
- 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
- A61F2/30721—Accessories
- A61F2/30734—Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect
-
- 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
-
- 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
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3662—Femoral shafts
- A61F2/367—Proximal or metaphyseal parts of shafts
-
- 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
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3662—Femoral shafts
- A61F2/3676—Distal or diaphyseal parts of shafts
-
- 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
- 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
- A61F2002/30092—Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30112—Rounded shapes, e.g. with rounded corners
- A61F2002/30125—Rounded shapes, e.g. with rounded corners elliptical or oval
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/302—Three-dimensional shapes toroidal, e.g. rings
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- 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
- 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
-
- 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
- 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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- 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
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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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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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- A61F2002/30329—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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- A61F2/00—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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- A61F2002/30329—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
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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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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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Definitions
- the present invention is directed to a modular orthopaedic implant prosthesis, and more particularly, to a hip prosthesis utilizing elements made of a shape memory alloy.
- Hip prostheses of various types are well known in the art.
- prostheses are surgically implanted in patients to secure one bone to another as replacements for damaged joints.
- a hip prosthesis is implanted to replace the joint which connects the leg bone or femur to the pelvic bone.
- the prosthesis replaces the hip joint.
- Femoral hip stem prostheses generally include a femoral stem section having a neck upon which a joint ball may be disposed.
- the prosthesis further includes an acetabular cup shell shaped to fit within the hip joint socket of the pelvic bone and a liner disposed within and adjacent to the concave surface of the cup shell.
- the joint ball is disposed so as to pivot within the liner, allowing the femur to move normally relative to the hip.
- a femoral hip stem prosthesis may be modular. It may be assembled from more than one section, with the sections joined together to form a complete prosthesis. Sections of the same overall shape and function but having different dimensions are interchangeable with each other. Thus, the practitioner may construct a femoral hip stem prosthesis of appropriate dimensions for a given patient by picking sections of a desired size and joining them together.
- the femoral stem section may include separate proximal and distal sections which are joined together by a locking screw extending through holes in the sections.
- the proximal section may include a neck upon which a separate femoral head is disposed to serve as a joint ball.
- the acetabular cup shell also is manufactured as a separate item.
- proximal and distal sections, the femoral head and the acetabular cup are manufactured in a plurality of sizes, for example, the proximal and distal sections would be manufactured in different lengths and diameters and the femoral head and cup shell would have different diameters. However, the locations at which the various components are joined together would have a uniform size and shape such that any distal section could be joined to any proximal section, and any femoral head could be disposed on the neck section of any proximal section. A cup shell and liner of appropriate diameter would be manufactured for each femoral head. Accordingly, the prosthesis may be assembled by a practitioner so as to have dimensions which are appropriate for a given patient by selecting proximal and distal sections, a femoral head, a cup shell and liner having desired dimensions.
- the acetabular cup shell is disposed in the hip socket, and secured to the pelvic bone, for example, by the use of a plurality of fastening elements such as pegs, pins or screws. These fastening elements are driven into the bone through holes in the cup shell.
- a liner is placed in the acetabular cup shell and secured thereto.
- a proximal and distal section having appropriate dimensions are selected and secured together by a locking screw to form the femoral stem section.
- a femoral head is disposed on the neck of the proximal section.
- the femoral head is disposed within the concave liner, and the femoral stem section is forcibly disposed within the hollow interior of the patients femur.
- the femoral stem section may be secured to the femur by shape fitting alone or by other conventional means such as cementing in place.
- Modular femoral stem prostheses assembled and implanted in this traditional manner suffer from certain drawbacks.
- the use of pins or screws to secure the acetabular cup shell to the pelvic bone allows for instability of the interface between the cup shell and the securing element heads, at the location of the holes.
- the instability results in micro-motion between the securing elements and the cup shell at the interface and creates frictional wear of the securing element and cup shell, further resulting in the creation of metallic debris.
- the locking screw which joins the modular components of the femoral stem for example, the above-described proximal and distal sections, may loosen over time and thus back out of the holes within which it is disposed. Thus, undesirable relative movement or total separation of the proximal and distal sections may result.
- SMA Shape memory alloys
- SMA's exist in a martensitic state below a first temperature and an austenitic state above a second temperature.
- SMA used for its shape memory properties in the specific context of orthopaedic devices is very limited.
- the present invention is directed to a prosthesis in which one or more of the elements are made from a shape memory alloy.
- the prosthesis is a modular stem prosthesis which includes a modular femoral stem section, joint ball and acetabular cup shell.
- the femoral stem section includes a proximal section and a distal section which are shaped to fit together.
- a locking screw extends through the proximal section and into the distal section to secure the sections together.
- the locking screw is made of a shape memory alloy which exists in a martensitic state below a first temperature and an austenitic state above a second temperature. The screw is formed in the austenitic state to have an original shape or dimensions.
- the locking screw is cooled to the martensitic state and deformed from its original shape or dimension while in the martensitic state, for example, by being stretched in length.
- the screw is disposed to secure the proximal and distal sections together while in the martensitic state, and thereafter, the screw is restored to the austenitic state by increasing its temperature above the second temperature.
- the screw undergoes a constrained recovery, that is, the screw attempts to recover its original dimensions but is blocked from making a full recovery due to its engagement with the proximal and distal sections within which it is disposed.
- a compressive load is created and acts upon the proximal and distal sections.
- the screw may undergo a constrained recovery by contracting, thereby drawing and locking the proximal and distal sections together. Accordingly, loosening of the locking screw is prevented, further precluding unwanted relative movement or separation of the proximal and distal sections.
- the acetabular cup shell is secured to the pelvic bone by the use of pegs or screws which are disposed through holes in the cup shell.
- the pegs or screws also are made out of a shape memory alloy which has been deformed while in the martensitic state, and after disposition to secure the cup shell to the pelvic bone, are restored to the austenitic state by raising the temperature above the second predetermined temperature.
- the resultant constrained restoration of the pegs or screws press fits them to the cup shell at the holes to prevent micro-motion therebetween.
- the prosthesis includes a modular head, a locking ring for the modular head and a distal sleeve, with the ring and/or sleeve made of SMA.
- the ring and sleeve are locked in position by the compressive forces created during the constrained recovery of the SMA.
- the prosthesis includes an SMA collar disposed about the proximal section, thereby transforming the prosthesis from collarless to collared.
- the collar is locked in place by the compressive forces created during the constrained recovery of the SMA.
- the prosthesis includes a modular proximal spacer made of SMA disposed about the femoral stem section.
- Figure 1 shows a femoral stem section of a modular hip stem prosthesis according to a first embodiment of the invention and including proximal and distal sections.
- Figure 2 shows a complete modular hip stem prosthesis including the femoral stem section of Figure 1, a joint ball disposed on the femoral stem section, a liner and an acetabular cup shell.
- Figure 3 shows a femoral stem section according to a second embodiment of the invention.
- Figure 4a shows the acetabular cup shell of Figure 2 having fixation screws disposed through the holes thereof according to a third embodiment of the invention.
- Figure 4b shows an acetabular cup shell of Figure 2 having modular pegs disposed through the holes thereof according to a fourth embodiment of the invention.
- Figures 5a-c show a femoral stem prosthesis according to a fifth embodiment of the invention including a locking ring and a distal sleeve which are made of SMA.
- Figures 6a-b show a femoral stem prosthesis according to a sixth embodiment of the invention including a modular collar made of SMA.
- Figures 7a-b show a femoral stem prosthesis according to a seventh embodiment of the invention including a modular spacer made of SMA.
- Prosthesis 1 includes femoral stem section 10, joint ball 40, liner 50 and acetabular cup shell 60, with the latter three elements shown only in Figure 2.
- Femoral stem section 10 includes proximal femoral section 12 and distal femoral section 14. (The terms proximal and distal refer to the location relative to the hip joint, and upon implantation, the proximal section would be disposed upwardly of the distal section.)
- Proximal section 12 includes recess 16 formed at its lower end. Recess 16 is tapered radially outwardly in the downward direction. Longitudinal bore 18 extends through proximal section 12 to the top of recess 16. Bore 18 includes widened area 19 at the top. Proximal section 12 further includes neck section 20 extending at an angle to the axis of longitudinal bore 18. Neck section 20 includes neck 22.
- Distal femoral section 14 includes protrusion 26 extending upwardly from the top end thereof.
- Protrusion 26 is tapered radially inwardly in the upward direction so as to substantially correspond to tapered recess 16.
- Protrusion 26 includes screw-threaded longitudinally extending hole 28 disposed partially therethrough.
- Proximal section 12 and distal section 14 may be disposed in a substantially fully contacting relationship as shown in Figure 2, with bore 18 aligned with hole 28 to form longitudinal cylindrical hole 24.
- Locking screw 30 is disposed through bore 18 and extends into hole 28.
- joint ball 40 such as a spherically shaped modular head would be disposed about neck 22 before implantation. After implantation, modular head 40 would fit within the concave surface of liner 50, which is disposed within the concave surface of cup shell 60.
- Proximal section 12, distal section 14, modular head 40, liner 50 and acetabular cup shell 60 are made of conventional materials which are known for use in such applications, and would be manufactured in a conventional manner.
- sections 12 and 14 may be made of titanium alloy
- modular head 40 may be made of CoCrMo alloy
- liner 50 may be made of ultra high molecular weight polyethylene
- cup shell 60 may be made of titanium alloy.
- Femoral stem section 10 is modular such that proximal section 12 and distal section 14 each would be manufactured of various sizes, for example, with various lengths and diameters. The range of lengths and diameters runs from 50-300 mm and 10-24 mm, respectively. However, the size and shape of tapered protrusion 26 and tapered recess 16 would be uniform for all distal and proximal sections, and in a preferred embodiment would have a length of 30 mm, a major diameter of 12.5 mm, and a minor diameter of 9 mm. Accordingly, the sections would be interchangeable such that any proximal section 12 would fit with any distal section 14.
- a prosthesis may be fitted to an individual patient by selecting a distal section and proximal section of appropriate size and securing them to each other by use of screw 30.
- the overall length of bore 18 and hole 28 also would be uniform.
- the size of neck 22 would be uniform for all proximal sections 12, with modular heads 40 of different diameters fitting thereon.
- Liner 50 and cup shell 60 would be selected to fit an individual patient.
- Locking screw 30 is manufactured of a shape memory alloy (SMA).
- SMA shape memory alloy
- SMA has the characteristic that when the alloy is cooled below a predetermined first temperature and subsequently deformed from its original shape by expanding or contracting when at or below this temperature, the alloy will return to its original shape or overall dimensions upon being raised above a second predetermined temperature.
- elements made from SMA exist in an austenitic state in a certain temperature range. When the temperature of the element is reduced below a first predetermined temperature, the SMA is transformed into a martensitic state and is more deformable in this state by contracting or expanding its dimensions, for example, the length.
- the SMA is "activated" and restored to its original shape or dimensions by either contracting or expanding.
- the SMA does not change states, for example, austenitic SMA which has been cooled from an original temperature in this range to below the first predetermined temperature so that the SMA transforms to the martensitic state, will remain in the martensitic state even if heated back to the original temperature.
- the SMA will not undergo transformation back to the austenitic state until heated above the second predetermined temperature.
- the first predetermined temperature may be 20°c and the second predetermined temperature may be 40°c.
- Locking screws 30 are manufactured in the austenitic state to have predetermined dimensions, such as a predetermined length, and are then cooled below the first predetermined temperature so as to be in the martensitic state. Thereafter, screws 30 are deformed, for example by expanding the length.
- screws 30 may be manufactured to have an initial length of 43 mm when in the austenitic state and be deformed to have an expanded length of 44 mm when in the martensitic state.
- locking screws 30 may be shipped to a site where they will be used, such as a hospital, and will remain in the martensitic state and retain the same length until needed for assembly of a prosthesis, assuming appropriate thermal protection is used.
- Femoral stem section 10 is constructed by the practitioner before installation into a patient. The practitioner selects a proximal section 12 and a distal section 14 of appropriate size, and assembles the sections together by inserting tapered protrusion 26 into tapered recess 16 so as to have a close fit as shown in Figures 1 and 2.
- Locking screw 30 while still deformed in the martensitic state is inserted through bore 18 from the top end thereof and is screwed into screw-threaded hole 28 to secure proximal section 12 to distal section 14.
- the overall length of cylindrical hole 24 preferably is slightly larger than the length of screw 30 such that a small clearance remains between the distal end of screw 30 and the bottom of hole 28, even after locking screw 30 is tightened to secure the sections together.
- the temperature of screw 30 is raised above the second predetermined temperature to transform the SMA back to the austenitic state.
- the shape memory property may be activated by placing the assembled femoral stem section 10 in warm water or by other means such as resistance heating or autoclaving. Screw 30 undergoes a constrained recovery, that is, the screw attempts to recover its length before being deformed but is blocked from making a full recovery due to its engagement with proximal section 12 and distal section 14 within which it is disposed. Thus, a compressive load is created and acts upon proximal section 12 and distal section 14, pulling proximal section 12 into even tighter contact with distal section 14, and locking or cinching the sections together. In one embodiment, upon activation, the screw will apply approximately 1500 lbs. of load on the sections.
- Locking screw 30 is, in effect, self-locking in cylindrical hole 24.
- the exact lengths of screw 30 and cylindrical hole 24 are a design choice. It is preferred that the length of locking screw 30 be slightly less than the length of cylindrical hole 24 when screw 30 is disposed to secure proximal section 12 to distal section 14, that is, before activation of the shape memory effect.
- locking screws 30 are made of alloys of Titanium and Nickel (TiNi), for example, the alloy sold under the name Nitinol.
- TiNi Titanium and Nickel
- an alloy containing 50% titanium and 50% nickel is preferred.
- Such an alloy can be made to transform completely from the austenitic state to the martensitic state below 20 °c and will transform completely back to the austenitic state above 50-60°c, at which point the original length of unconstrained screws 30 will be recovered.
- Femoral stem section 100 includes proximal section 112, distal section 114 and separate neck section 122.
- Proximal section 112 includes upper recess 116 and lower recess 119.
- Lower recess 119 is tapered radially outwardly in the downward direction.
- Upper recess 116 includes upper section 116a which is tapered radially outwardly in the upward direction and lower cylindrical-shaped section 116b.
- Ledge 117 is formed between lower section 116b and upper section 116a. Bore 118 extends through proximal section 112.
- Distal section 114 includes protrusion 126 extending upwardly from the top end thereof and tapered radially inwardly in the upward direction so as to substantially correspond to lower tapered recess 119. Screw-threaded hole 128 is formed in protrusion 126.
- Neck section 122 includes projection 122a which is tapered radially inwardly in the lower direction and cylindrical projection 122b which projects downwardly from the lower surface of projection 122a. Peripheral surface 123 is defined between projections 122a and 122b. Cylindrical projection 122b corresponds in shape and size to lower cylindrical-shaped section 116b, tapered projection 122a correspond in shape and size to upper tapered section 116a, and peripheral surface 123 corresponds in shape and size with ledge 117. Longitudinal bore 125 is formed through neck section 122.
- Neck section 122 further includes neck 124.
- Femoral stem section 110 is assembled in a similar manner to section 10 disclosed in Figures 1 and 2.
- Neck section 122 is inserted within upper recess 116 of proximal section 112, with cylindrical projection 122b fitting within cylindrical- shaped section 116b, tapered projection 122a fitting within tapered recess 116a and peripheral surface 123 disposed on ledge 117.
- Protrusion 126 of distal section 114 is inserted within tapered recess 119 of proximal section 112. Bores 118 and 125 and hole 128 are aligned to form longitudinal cylindrical hole 127.
- SMA locking screw 30 which is in the deformed martensitic state, is disposed through cylindrical hole 127 and tightened to secure the sections of femoral stem section 110 together. Thereafter, the shape memory effect is activated by heating locking screw 30 beyond the second predetermined temperature, transforming the SMA back to the austenitic state and causing locking screw 30 to attempt to contract back to its original length. That is, locking screw 30 undergoes a constrained recovery, and thereby applies a compressive load on proximal section 112, distal section 114, and neck section 122, pulling the sections into even tighter contact with each other, and locking the sections together.
- head 30a of locking screw 30 can be manufactured to have an undersurface 30b which is mechanically textured or roughened.
- the roughened or textured surface increases the frictional holding power and further inhibits loosening when screw 30 undergoes recovery.
- the use of a roughened or textured surface, and the advantages obtained by such use, are not possible with prior art locking screws due to the particulate debris which are created during the torsional tightening.
- modular head 40 is disposed about neck 22 (or 122), and prosthesis 1 is ready for implantation into a patient.
- Acetabular shell cup 60 is inserted into the hip joint socket in the pelvic bone and secured thereto.
- Liner 50 is inserted within the concave surface of shell cup 60 and secured thereto in a known manner.
- Modular head 40 is inserted within the concave surface of liner 50 to secure the femoral stem section within the pelvic bone so as to pivot.
- the femoral stem section is fitted into the femur and secured thereto in a known manner, for example, by press fitting or cementing, to complete the implantation of prosthesis 1.
- Cup shell 60 includes screw holes 62 disposed therethrough.
- Screw holes 62 include smaller diameter radially outer portion 62a which is essentially cylindrical, and larger diameter radially inner portion 62b which is essentially hemispheric in shape.
- Cup shell 60 includes inner ledge 62c which is defined between portions 62a and 62b. The diameter of holes 62 is slightly decreased at the location of ledge 62c so that it is less than the diameter at outer portion 62a.
- Fixation or securing screws 64 are disposed through holes 62, and include screw- threaded shank portion 64a, head 64b and indented region 64c formed between shank portion 64a and head 64b. Screws 64 are made of SMA, for example, the alloys identified above with respect to locking screw 30.
- screws 64 are cooled below the temperature at which the SMA is transformed to the martensitic state and are then deformed.
- screws 64 are deformed by being extended in length, and remain in that state at normal room or environmental temperatures until the prosthesis is implanted by the practitioner.
- the diameter of shank portion 64a in the un-recovered state is slightly less than the diameter of ledge 62c.
- Cup 60 is inserted into the hip socket of the pelvic bone, and is secured to the bone by screws 64 which are inserted through holes 62 and driven into the pelvic bone.
- screws 64 After screws 64 are fully driven into the bone, they are heated above the second predetermined temperature and are transformed back to the austenitic state. Screws 64 undergo a constrained recovery, for example, by contracting in length,
- Pegs 74 also are made of SMA, and include shank portion 74a, head 74b and indented region 74c. As with screws 64, the diameter of shank portion 74a in the un-recovered state is slightly less than the diameter of hole 62 at the location of ledge 62c. Pegs 74 are deformed so as to be extended when in the martensitic state. Pegs 74 are driven into the pelvic bone by the practitioner to secure cup shell 60. Pegs 74 are then heated back to the austenitic state and contracted, providing an additional mechanism for locking the screws in place.
- Femoral stem section 10' includes proximal section 12' and distal section 14'.
- Proximal section 12' includes neck section 20' having tapered neck 22'.
- Modular femoral head 140 includes upper spherical or ball portion 140b and lower cylindrical portion or collar 140a. Tapered recess 141 extends through collar 140a and into ball portion 140b.
- Modular femoral head 140 is disposed on proximal section 12' with neck 22' fitting within tapered recess 141.
- Channel 142 is formed about the periphery of collar 140a.
- Circular locking ring 144 is disposed in channel 142.
- Femoral stem section 10' also includes circular groove 146a formed in distal section 14'. Distal sleeve 146 is disposed in groove 146.
- Locking ring 144 is disposed in channel 142 and also serves to secure modular head 140 on neck 22'.
- Locking ring 144 is made of SMA, and is shrink- fitted onto head 140 to eliminate any gaps which may exist between head 140 and neck 22' at the location of channel 142.
- SMA locking ring 144 further locks head 140 in place on neck 22' and reduces the potential for entrapment of particles in the incongruities between tapered recess 141 and tapered neck 22', thereby reducing the potential for crevice corrosion.
- Distal sleeve 146 is disposed about distal section 14' near the lower end thereof by sliding into circular groove 146a.
- Distal sleeve 146 serves as a spacer to ensure a tight fit between femoral stem section 10' and the femur.
- Distal sleeve 146 also may be made of SMA and is shrink-fitted onto distal section 14' in the same manner as described above, providing an improved mechanical locking of sleeve 146 to distal section 14'.
- femoral stem section 10' includes modular collar 160 made of SMA.
- Proximal section 12' includes neck section 20'.
- Recessed channel 161 is formed in proximal section 12' at the base of neck section 20'.
- Channel 161 includes indented portions 162 formed therein on opposite sides of proximal section 12'.
- Collar 160 has an open oval shape, and includes projections 160a extending from the open ends. Collar 160 is fitted into channel 161 with projections 160a fitting within indented portions 162 to secure collar 160 in position, and thereby transform femoral stem section 10' from collarless to collared.
- Collar 160 is shrink-fitted on proximal section 12' by restoration to the austenitic state in the same manner as discussed above, to lock collar 160 in position.
- femoral stem section 10' includes modular proximal spacer 200 made of SMA.
- Spacer 200 allows for augmentation and customizing of the femoral stem section.
- Stem section 10" includes collar 242 disposed at the base of the neck section.
- Spacer 200 is oval-shaped with an open center and is disposed about the lower portion of stem section 10" by sliding upwardly until it contacts collar 242.
- Spacer 200 is shrink-fitted on stem sections 10" in the same manner as discussed above with respect to sleeve 146, locking ring 144 and collar 160 in order to secure spacer 200 to femoral stem section 10".
- femoral stem section 10" is shown as comprising only one section, stem section 10" may be modular and include separate distal and proximal sections as shown in Figure 1.
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Section modulaire (10) de tige fémorale comportant une partie proximale (12) et une partie distale (14). Une vis de blocage (30) passe à travers la partie proximale et aboutit dans la partie distale de façon à les rendre solidaires. Plusieurs vis (64) ou chevilles (74) de fixation servent à fixer une calotte cotyloïde (60) à l'os iliaque. Les vis de blocage et les vis ou chevilles de fixation sont en alliage à mémoire de forme (SMA). Les vis et chevilles de fixation sont en alliage à mémoire de forme (SMA). Les vis et chevilles sont déformées à une température inférieure à un seuil donné puis mises en place pour rendre solidaires les parties proximale et distale ou fixer la calotte à l'os iliaque alors qu'elles se trouvent à l'état déformé. Puis les vis ou chevilles sont portées à une seconde température supérieure à un second seuil donné où elles subissent une restauration sous contrainte. Dans d'autres réalisations, la prothèse peut comporter d'autres éléments additionnels en SMA frettés sur la prothèse.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US15399293A | 1993-11-18 | 1993-11-18 | |
US08/153,992 | 1993-11-18 |
Publications (1)
Publication Number | Publication Date |
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WO1995013757A1 true WO1995013757A1 (fr) | 1995-05-26 |
Family
ID=22549573
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US1994/012943 WO1995013757A1 (fr) | 1993-11-18 | 1994-11-16 | Prothese modulaire a elements d'alliage a memoire de forme |
Country Status (1)
Country | Link |
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WO (1) | WO1995013757A1 (fr) |
Cited By (18)
Publication number | Priority date | Publication date | Assignee | Title |
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WO1997020525A1 (fr) * | 1995-12-05 | 1997-06-12 | Metagen, Llc | Prothese modulaire |
EP0788782A1 (fr) * | 1996-02-08 | 1997-08-13 | André Georges Deckner | Prothèse articulaire assemblée par gradins |
WO1998017207A1 (fr) * | 1996-10-21 | 1998-04-30 | Synthes Ag Chur | Prothese chirurgicale |
WO1999048443A1 (fr) * | 1998-03-20 | 1999-09-30 | Johnson & Johnson Medical Limited | Element de centrage |
FR2797275A1 (fr) * | 1999-08-04 | 2001-02-09 | Mat Inov | Procede pour memoriser deux etats geometriques d'un produit realise dans un alliage a memoire de forme et applications de ce procede a des produits dans le domaine medical, dentaire, veterinaire ou autres |
FR2799115A1 (fr) * | 1999-10-01 | 2001-04-06 | Jean Claude Bouvet | Tige modulaire pour prothese de hanche |
EP1004283A3 (fr) * | 1998-11-23 | 2002-03-27 | Johnson & Johnson Professional, Inc. | Prothèse modulaire à tige et manchon |
EP1191906A1 (fr) * | 2000-03-13 | 2002-04-03 | Exactech, Inc. | Prothese modulaire de la hanche |
WO2005060876A1 (fr) * | 2003-12-12 | 2005-07-07 | Mariasal Investment N.V. | Organe cupuliforme cotyloidien pour prothese de la hanche a tige fixee par des moyens de liaison |
FR2864889A1 (fr) * | 2004-01-14 | 2005-07-15 | Georges Pierre Gauthier | Materiel d'osteosynthese ou prothetique, notamment vis et clou |
EP1269937A3 (fr) * | 2001-06-30 | 2005-07-20 | Depuy Orthopaedics, Inc. | Prothèse avec collerette biodégradable |
DE202010008404U1 (de) | 2010-08-31 | 2010-12-09 | Implantech Medizintechnik Gmbh | Navigationskugelkopf mit Safe-Zone |
US7947135B2 (en) | 2007-03-26 | 2011-05-24 | Mx Orthopedics Corp. | Proximally self-locking long bone prosthesis |
US8048167B2 (en) | 2005-08-30 | 2011-11-01 | Depuy Products, Inc. | Orthopaedic implant kit, orthopaedic surgery kit and associated method |
WO2014189765A1 (fr) * | 2013-05-23 | 2014-11-27 | Zimmer, Inc. | Écrou chauffé pour tige de prothèse modulaire de hanche |
CN107307927A (zh) * | 2012-05-08 | 2017-11-03 | 德普伊爱尔兰无限公司 | 假体股骨部件 |
WO2018156786A1 (fr) * | 2017-02-23 | 2018-08-30 | Encore Medical, L.P. (D/B/A Djo Surgical) | Système d'implant de hanche |
CN110393613A (zh) * | 2019-08-14 | 2019-11-01 | 北京市春立正达医疗器械股份有限公司 | 一种肘关节假体 |
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Cited By (38)
Publication number | Priority date | Publication date | Assignee | Title |
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WO1997020525A1 (fr) * | 1995-12-05 | 1997-06-12 | Metagen, Llc | Prothese modulaire |
AU730597B2 (en) * | 1995-12-05 | 2001-03-08 | Orthopaedic Innovations, Inc. | Modular prosthesis |
WO1998055051A1 (fr) * | 1995-12-05 | 1998-12-10 | Metagen, Llc | Prothese modulaire |
US5858020A (en) * | 1995-12-05 | 1999-01-12 | Metagen, Llc | Modular prosthesis |
EA000291B1 (ru) * | 1995-12-05 | 1999-02-25 | Митаджен, Ллс | Модульный протез |
EP0788782A1 (fr) * | 1996-02-08 | 1997-08-13 | André Georges Deckner | Prothèse articulaire assemblée par gradins |
FR2744626A1 (fr) * | 1996-02-08 | 1997-08-14 | Deckner Andre Georges | Prothese articulaire assemblee par gradins |
US5755789A (en) * | 1996-02-08 | 1998-05-26 | Deckner; Andre Georges | Articular prosthesis assembled in steps |
WO1998017207A1 (fr) * | 1996-10-21 | 1998-04-30 | Synthes Ag Chur | Prothese chirurgicale |
US6019793A (en) * | 1996-10-21 | 2000-02-01 | Synthes | Surgical prosthetic device |
WO1999048443A1 (fr) * | 1998-03-20 | 1999-09-30 | Johnson & Johnson Medical Limited | Element de centrage |
AU769910B2 (en) * | 1998-11-23 | 2004-02-12 | Depuy Orthopaedics, Inc. | Modular stem and sleeve prosthesis |
EP1004283A3 (fr) * | 1998-11-23 | 2002-03-27 | Johnson & Johnson Professional, Inc. | Prothèse modulaire à tige et manchon |
FR2797275A1 (fr) * | 1999-08-04 | 2001-02-09 | Mat Inov | Procede pour memoriser deux etats geometriques d'un produit realise dans un alliage a memoire de forme et applications de ce procede a des produits dans le domaine medical, dentaire, veterinaire ou autres |
WO2001011097A1 (fr) * | 1999-08-04 | 2001-02-15 | Mat Inov Sarl | Procede pour memoriser un alliage a memoire de forme |
FR2799115A1 (fr) * | 1999-10-01 | 2001-04-06 | Jean Claude Bouvet | Tige modulaire pour prothese de hanche |
EP1191906A1 (fr) * | 2000-03-13 | 2002-04-03 | Exactech, Inc. | Prothese modulaire de la hanche |
EP1191906A4 (fr) * | 2000-03-13 | 2003-04-16 | Exactech Inc | Prothese modulaire de la hanche |
EP1269937A3 (fr) * | 2001-06-30 | 2005-07-20 | Depuy Orthopaedics, Inc. | Prothèse avec collerette biodégradable |
US7261741B2 (en) | 2001-06-30 | 2007-08-28 | Depuy Products, Inc. | Prosthesis with resorbable collar |
WO2005060876A1 (fr) * | 2003-12-12 | 2005-07-07 | Mariasal Investment N.V. | Organe cupuliforme cotyloidien pour prothese de la hanche a tige fixee par des moyens de liaison |
FR2864889A1 (fr) * | 2004-01-14 | 2005-07-15 | Georges Pierre Gauthier | Materiel d'osteosynthese ou prothetique, notamment vis et clou |
US8048167B2 (en) | 2005-08-30 | 2011-11-01 | Depuy Products, Inc. | Orthopaedic implant kit, orthopaedic surgery kit and associated method |
US7947135B2 (en) | 2007-03-26 | 2011-05-24 | Mx Orthopedics Corp. | Proximally self-locking long bone prosthesis |
US8062378B2 (en) | 2007-03-26 | 2011-11-22 | Mx Orthopedics Corp. | Proximal self-locking long bone prosthesis |
US8137486B2 (en) | 2007-03-26 | 2012-03-20 | Mx Orthopedics, Corp. | Proximally self-locking long bone prosthesis |
US8398790B2 (en) | 2007-03-26 | 2013-03-19 | Mx Orthopedics, Corp. | Proximally self-locking long bone prosthesis |
DE202010008404U1 (de) | 2010-08-31 | 2010-12-09 | Implantech Medizintechnik Gmbh | Navigationskugelkopf mit Safe-Zone |
DE102011052483A1 (de) | 2010-08-31 | 2012-03-29 | Implantech Medizintechnik Gmbh | Navigationskugelkopf mit Safe-Zone |
DE202011110720U1 (de) | 2010-08-31 | 2015-11-02 | Implantech Medizintechnik Ges.M.B.H | Navigationskugelkopf mit Safe-Zone |
CN107307927A (zh) * | 2012-05-08 | 2017-11-03 | 德普伊爱尔兰无限公司 | 假体股骨部件 |
WO2014189765A1 (fr) * | 2013-05-23 | 2014-11-27 | Zimmer, Inc. | Écrou chauffé pour tige de prothèse modulaire de hanche |
US10213312B2 (en) | 2013-05-23 | 2019-02-26 | Zimmer, Inc. | Heated bolt for modular hip stem |
WO2018156786A1 (fr) * | 2017-02-23 | 2018-08-30 | Encore Medical, L.P. (D/B/A Djo Surgical) | Système d'implant de hanche |
JP2020517404A (ja) * | 2017-02-23 | 2020-06-18 | エンコア・メディカル・エル・ピー・(ディー/ビー/エー・ディージェーオー・サージカル) | 股関節インプラントシステム |
US11039930B2 (en) | 2017-02-23 | 2021-06-22 | Encore Medical, L.P. | Hip implant system |
JP7116092B2 (ja) | 2017-02-23 | 2022-08-09 | エンコア・メディカル・エル・ピー・(ディー/ビー/エー・ディージェーオー・サージカル) | 股関節インプラントシステム |
CN110393613A (zh) * | 2019-08-14 | 2019-11-01 | 北京市春立正达医疗器械股份有限公司 | 一种肘关节假体 |
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