WO2021004663A1 - Kit de dispositifs chirurgicaux orthopédiques pour la fourniture d'un implant de prothèse fémorale cimenté - Google Patents

Kit de dispositifs chirurgicaux orthopédiques pour la fourniture d'un implant de prothèse fémorale cimenté Download PDF

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Publication number
WO2021004663A1
WO2021004663A1 PCT/EP2020/058956 EP2020058956W WO2021004663A1 WO 2021004663 A1 WO2021004663 A1 WO 2021004663A1 EP 2020058956 W EP2020058956 W EP 2020058956W WO 2021004663 A1 WO2021004663 A1 WO 2021004663A1
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WO
WIPO (PCT)
Prior art keywords
diaphyseal
prosthetic
test
canal
stem
Prior art date
Application number
PCT/EP2020/058956
Other languages
English (en)
Inventor
Guido Grappiolo
Francesco Falez
Original Assignee
Adler Ortho S.P.A.
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Filing date
Publication date
Application filed by Adler Ortho S.P.A. filed Critical Adler Ortho S.P.A.
Publication of WO2021004663A1 publication Critical patent/WO2021004663A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4607—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of hip 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
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/164—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans intramedullary
    • 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
    • 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
    • A61B17/1664—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
    • 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
    • A61F2/3662—Femoral shafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4684—Trial or dummy prostheses
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8897—Guide wires or guide pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—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
    • 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
    • A61F2002/30316—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
    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30616—Sets comprising a plurality of prosthetic parts of different sizes or orientations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—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
    • A61F2002/30617—Visible markings for adjusting, locating or measuring
    • 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
    • A61F2002/3625—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
    • A61F2/32—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
    • A61F2/32—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
    • A61F2002/3652—Connections of necks to shafts
    • 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

Definitions

  • the present invention relates to kit of orthopedic surgical devices the provision of a femoral prosthesis implant and in particular of a cemented femoral prosthesis implant.
  • a prosthetic joint replacement implant As is known, in orthopedics, a prosthetic joint replacement implant, or“prosthesization”, is the substitution of a joint with a similar structure but of artificial origin, known as a prosthetic replacement joint.
  • the present invention has application specifically in the prosthesization of the femur and/or in the prosthesization of the hip, and more precisely in the substitution of the proximal portion of the femur which forms the coxofemoral (hip-femur) joint.
  • the prosthesis normally comprises a stem which is inserted in the conveniently modeled diaphyseal canal, a neck which protrudes from the diaphyseal canal and forms, with the stem, a suitable cervical-diaphyseal angle, and a head fixed to the end of the neck, which in practice functionally substitutes the head of the femur.
  • the diaphyseal canal is prepared with a rasp, which is shaped like the stem to be inserted and is moved by the surgeon along the axis of the diaphysis.
  • the diaphyseal canal is filled with the cement and then the prosthetic stem is inserted, while removing the excess cement.
  • the use of cement offers the advantage of implanting a femoral stem even if the surrounding bone is of low quality and therefore not capable of offering adequate bone regrowth to ensure the stability of the implant.
  • the greater or lesser sinking of the stem into the mantle of cement makes it possible to optimize the position of the head center and therefore to reconstruct the anatomy of the patient.
  • the aim of the present invention consists of providing a kit of orthopedic surgical devices for the provision of a cemented femoral prosthesis implant that solves the above technical problem, eliminates the drawbacks and overcomes the limitations of the known art, thus making the correct reconstruction of the anatomy of the patient simpler and less dependent on the abilities of the surgeon, while at the same time retaining the advantages of using cement.
  • an object of the present invention is to provide a kit of orthopedic surgical devices for the provision of a cemented femoral prosthesis implant that makes it possible to correctly position the head center of the prosthesis via a standardized implant procedure.
  • Another object of the invention is to provide a kit of orthopedic surgical devices for the provision of a cemented femoral prosthesis implant that makes it possible to provide an implant procedure that makes it possible to reconstruct the anatomy of the patient in a simpler and more precise manner.
  • Another object of the invention consists of providing a kit of orthopedic surgical devices for the provision of a cemented femoral prosthesis implant that makes it possible for the surgeon to have objective reference points during the implant procedure.
  • a cemented femoral prosthesis implant which comprises at least one rasp for shaping a diaphyseal canal in a femur and at least one prosthetic stem which is adapted to be fixed inside said diaphyseal canal in an anatomical position for use, characterized in that it comprises:
  • a plurality of rasps which have mutually different dimensions and are configured to model the diaphyseal canal so as to make it compatible with the insertion of said stem and to engage said diaphyseal canal during an adjustment step
  • test necks which have mutually different shapes and/or dimensions and are provided with detachable coupling means which make it possible to removably couple each one of said test necks to each one of said rasps, in said adjustment step,
  • test heads which are provided with removable coupling means which make it possible to removably couple each one of said test heads to each one of said test necks, in said adjustment step.
  • Figure 1 is a view of some of the orthopedic surgical devices of a possible embodiment of the kit, according to the invention.
  • Figure 2 is a side view of a generic rasp of the kit in Figure 1;
  • Figure 3 is a side view of a generic prosthetic stem of the kit in Figure 1 ;
  • Figure 4 is a cross-sectional view taken along a vertical plane of a rasp inserted into the diaphyseal canal of a femur;
  • Figure 5 shows possible couplings of a rasp with test necks and with test heads of the kit in Figure 1 ;
  • Figure 6 is a side view of a plurality of standard test necks of a kit according to the invention.
  • Figure 7 is a side view of a test head of a kit according to the invention.
  • Figure 8 is a cross-sectional view of the head in Figure 7 coupled to the end of a test neck;
  • Figures 9A-9C are cross-sectional views, taken along a vertical plane, of three different prosthetic stems inside the diaphyseal canal;
  • Figures 10A-10D are side views of a same prosthetic stem inserted into the diaphyseal canal with different degrees of sinking;
  • Figure 11 contains three graphs, each one illustrating the head center positions that can be tested with a different rasp
  • Figure 12 is a cross-sectional view of the insertion of a prosthetic stem into the diaphyseal canal with the aid of a guiding wire connected to the diaphyseal plug, according to an embodiment of the present invention
  • Figure 13 is a cross-sectional view of the insertion of a prosthetic stem into the diaphyseal canal with the aid of a centering device, according to an embodiment of the present invention
  • Figure 14 is a perspective view of a centering device illustrated in Figure 13.
  • the kit of orthopedic surgical instruments (or devices) for the provision of a cemented femoral prosthesis implant comprises a plurality of rasps (designated with the reference numeral 2 optionally followed by a letter a-q to designate different dimensions) for modeling the diaphyseal canal D in a femur F.
  • a rasp 2 is the instrument with which the diaphyseal canal D is modeled (i.e. shaped) into which the prosthetic stem (generally designated with the reference numeral 5, optionally followed by a letter a-e to designate different dimensions) will be inserted.
  • each rasp 2a-2q is provided, in a known manner, with teeth or serrations 21 along the external wall and is therefore configured to remove internal tissue from the femur F when it is moved with an alternating motion along the axis of the diaphysis, so as to model the diaphyseal canal D.
  • each rasp 2a-2q is substantially wedge-shaped and more precisely each rasp 2a-2q has a shape and dimensions that are substantially similar to the diaphyseal portion 54 of a respective stem 5a-5e covered by an adapted mantle of cement.
  • rasps 2a-2q are configured to engage the diaphyseal canal D during an adjustment step which precedes the insertion and fixing of the prosthetic stem 5a-5e inside such diaphyseal canal D.
  • the rasps 2a, 2b, 2c will be used to make impressions (i.e. modeled diaphyseal channels D) that are such as to accommodate the prosthetic stem 5a.
  • the impression made with the rasp 2a ensures a space for the prosthetic stem 5a with a mantle of cement of 1 mm thickness.
  • the impressions made with the rasps 2b and 2c provide a greater space, and the thickness of the mantle of cement will be greater.
  • the rasps 2d, 2e, 2f are used to make impressions that are such as to accommodate the prosthetic stem 5b.
  • the impression made with the rasp 2d ensures a space for the prosthetic stem 5b with a mantle of cement of 1 mm thickness.
  • the impressions made with the rasps 2e and 2f provide a greater space, and the thickness of the mantle of cement will be greater.
  • the rasps 2g, 2h, 2i are used to make impressions that are such as to accommodate the stem 5c.
  • the impression made with the rasp 2g ensures a space for the stem 5c with a mantle of cement of 1 mm thickness.
  • the impressions made with the rasps 2h and 2i provide a greater space, and the thickness of the mantle of cement will be greater.
  • the rasps 21, 2m, 2n are used to make impressions that are such as to accommodate the stem 5d.
  • the impression made with the rasp 21 ensures a space for the stem 5d with a mantle of cement of 1 mm thickness.
  • the impressions made with the rasps 2m and 2n provide a greater space, and the thickness of the mantle of cement will be greater.
  • the rasps 2o, 2p, 2q are used to make impressions that are such as to accommodate the stem 5e.
  • the impression made with the rasp 2o ensures a space for the stem 5e with a mantle of cement of 1 mm thickness.
  • the impressions made with the rasps 2p and 2q provide a greater space, and the thickness of the mantle of cement will be greater.
  • stems 5a-5e and rasps 2a-2q just described should be understood as a non-limiting example: the number of stems and rasps can be greater than those illustrated and described here.
  • Each rasp 2a-2q is preferably provided with a seat 22 or engagement means for removably coupling a handle and/or seats or coupling means for removably coupling the test necks 3a-3g which will be described below.
  • each rasp 2a-2q is provided with a turret 29 of variable height t according to the size in order to be able advantageously to use the same necks.
  • the kit comprises a plurality of prosthetic stems 5a, 5b, 5c, 5d, 5e, which have mutually different dimensions and are adapted to be fixed to the inside of the diaphyseal canal D in an anatomical position for use as illustrated for example in Figures 9A-9D and 10A-10D.
  • anatomical position for use means the position in which the prosthesis anatomically and functionally reconstructs the femur.
  • the prosthetic stems 5a-5e comprise a diaphyseal portion 54, which extends longitudinally along a diaphyseal axis Y and which in the anatomical position for use is inserted at least partially inside the diaphyseal canal D, and a neck portion 55, which extends along a cervical axis X and which in the anatomical position for use is outside of the diaphyseal canal D and protrudes towards the hip joint of the patient.
  • the diaphyseal axis Y forms, with the cervical axis X, a cervical- diaphyseal angle c preferably comprised between 110° and 140°, which in the preferred and illustrated embodiment is 127° (as shown in Figure 3).
  • the neck portion 55 of the prosthetic stem 5a-5e there is an engagement portion 59 adapted to be mechanically coupled with a prosthetic head (not shown since it is conventional).
  • the neck portion 55 has a substantially circular cross-section and the engagement portion 59 is constituted by a portion that has a diameter that is greater than the rest of the neck portion 55.
  • the kit further comprises a plurality of test necks 3a-3g which have mutually different shapes and/or dimensions.
  • each test neck 3a-3d has a head end 33 which is centered on a different head axis a, b, g, d which constitutes the axis along which is located the head center of the test heads 4a-4d (described below) which are coupled with such test neck 3a-3d.
  • test necks 3a-3d are, in other words, independent of the neck portion, and in the adjustment step they are temporarily fixed to the rasp 2a- 2q that is engaging the diaphyseal canal D so as to be positioned like the neck portion 55 of a prosthetic stem 5a-5e when it is in the anatomical position for use.
  • test necks 3a-3g are provided with removable coupling means which make it possible to removably couple each one of such test necks 3a- 3g to each one of the rasps 2a-2q, such as for example interlocking elements 34 that are complementary to the seats 22 present on the rasps 2a-2q.
  • the kit also comprises a plurality of test heads 4a-4d which are provided with removable coupling means which make it possible to removably couple each one of such test heads 4a-4d to each one of the test necks 3a-3g, in the adjustment step.
  • test heads 4a-4d have substantially the same outer shape as the prosthetic heads and, when in the adjustment step they are temporarily fixed to a test neck 3a-3d which in turn is temporarily fixed to a rasp 2a-2q, they are located in the same position as a prosthetic head in the anatomical position for use.
  • each test head 4a-4d corresponds uniquely to a respective prosthetic head, of which it has the same shape and dimensions.
  • each test head 4a-4d when in the adjustment step, is temporarily fixed to a test neck 3a-3g which in turn is temporarily fixed to a rasp 2a-2q, defines a head center that can therefore be tried empirically and which corresponds to the head center that a prosthetic head which is coupled to a respective prosthetic stem 5a-5e in the anatomical position for use will have.
  • head center means the geometric center of the prosthetic head which, in practice, acts as a fulcrum for the coxofemoral joint.
  • the removable coupling means with which the test necks 3a-3g and the test heads 4a-4d are provided can comprise coupling cavities 41, screws, threaded pins, interlocking or bayonet systems or male-female coupling systems, or other conventional elements for coupling.
  • each test head 4a-4d comprises a coupling cavity 41 which is adapted to be engaged by a head end 33 of a test neck 3a-3g in order to provide the removable coupling, as shown in Figure 8.
  • the kit comprises, for each prosthetic stem 5a-5e, a plurality of rasps 2a-2q, which have mutually different dimensions and are configured to model the diaphyseal canal D so as to make it compatible with the insertion of such prosthetic stem 5a-5e.
  • the kit comprises at least five prosthetic stems 5a-5e and, for each one of such prosthetic stems 5a-5e, at least three, and even more preferably exactly three, rasps 2a-2q which have mutually different dimensions and are configured to model the diaphyseal canal D so as to make it compatible with the insertion of such prosthetic stem 5a-5e (therefore, at least fifteen rasps 2a-2q).
  • the kit comprises five stems 5a-5e, for each one of which the kit comprises three respective rasps 2a-2q (therefore fifteen rasps 2a-2q).
  • the five prosthetic stems 5a-5e have the neck portion 55 oriented along the standard plane (i.e., as is known in orthopedics, along the plane of symmetry of the prosthetic stem) and the kit further comprises, for each prosthetic stem 5a-5e, two complementary prosthetic stems (not shown): an anteverted complementary prosthetic stem that has the diaphyseal portion identical to the respective prosthetic stem 5a- 5e and the neck portion oriented along an anteverted plane(i.e., as is known in orthopedics, along a plane rotated in anteversion with respect to the standard plane) and a retroverted complementary prosthetic stem that has the diaphyseal portion identical to the respective prosthetic stem 5a-5e and the neck portion oriented along a retroverted plane (i.e., as is known in orthopedics, along a plane rotated in retroversion with respect to the standard plane).
  • a retroverted complementary prosthetic stem that has the diaphyseal portion identical to the respective prosthetic stem 5a-5e and the neck portion oriented along
  • the kit comprises at least four standard test necks 3a-3d which have mutually different shapes and/or dimensions and even more preferably four standard test necks 3a-3d plus, in addition, another three extra-offset test necks 3e-3g (i.e. over-dimensioned) which have larger dimensions than the four standard test necks 3a-3d.
  • each test neck 3e- 3g has a head end 33 that is centered on a head axis bE, gE, dE which corresponds to a respective head axis b, g, d of a standard test neck 3a-3d.
  • test necks are shaped so that, when they are temporarily fixed to the rasp 2a-2q that engages the diaphyseal canal D in the adjustment step, they are positioned like the neck portion 55 of a standard prosthetic stem 5a-5e when it is in the anatomical position for use.
  • the kit further comprises:
  • the anteverted test necks are shaped so that, when they are temporarily fixed to the rasp 2a-2q that engages the diaphyseal canal D in the adjustment step, they are positioned like the neck portion of an anteverted complementary prosthetic stem when it is in the anatomical position for use.
  • the retroverted test necks are shaped so that, when they are temporarily fixed to the rasp 2a-2q that engages the diaphyseal canal D in the adjustment step, they are positioned like the neck portion of a retroverted complementary prosthetic stem when it is in the anatomical position for use.
  • each combination of a rasp 2a-2q with a test neck 3a-3g and a test head 4a-4d corresponds to a different position of the head center.
  • the cervical- diaphyseal angle C is 127°, and such angle, in addition to being closer to the anatomical angle, has the advantage of determining a greater displacement of the offset than that of the height (3.2 mm with respect to 2.4 mm, as indicated in Figure 11).
  • test necks 3a-3g determine a variation only in height, while the variation in offset is obtained with the use of different heads from -4 mm to + 8 mm (see Figure 11).
  • Figures 10A, 10B, IOC, 10D show how what is described in Figure 11 is achieved in terms of implantation. Also in the example shown, the reference markings 52 on the prosthetic stem 5 make it possible to determine and check a sink of 2.4 mm.
  • At least sixteen head center positions can be tried out for each rasp 2a-2q and this number can increase to twenty-two with the use of the extra-offset test necks 3e-3g, for the standard plane alone, and likewise on the retroverted plane and likewise for the anteverted plane.
  • each table shows (represented with a circle) the positions of the head center that can be tried out with a single rasp 2a-2q
  • the preferred embodiment which comprises fifteen rasps 2a-2q
  • Figure 11 illustrates the head center positions corresponding to the first prosthetic stem 5a (which are associated with the first three rasps 2a-2c), for the standard plane only.
  • the prosthetic stems 5a-5e and the complementary prosthetic stems comprise a plurality of reference markings 52, on the neck portion 53 and/or on the diaphyseal portion, and preferably in a boundary region between such two portions, which are adapted to provide an operator who is providing the implant (i.e. a surgeon) with a visual reference in order to check the depth at which the prosthetic stem 5a-5e is to be fixed inside the diaphyseal canal D.
  • the reference markings 52 are incisions or graphic signs or bumps and preferably comprise linear incisions in the manner of notches; in the example shown there are four reference markings constituted by four linear incisions in the manner of notches.
  • each of the reference markings 52 provides a reference point, with respect to the femur F, that makes it possible to identify a degree of sinking of the prosthetic stem 5a-5e, inside the diaphyseal canal D, that corresponds to a preset position of the head center when the prosthetic stem 5a-5e is coupled to a preset prosthetic head.
  • each prosthetic stem 5a-5e there is an adapted number of reference markings 52, so that each pair of prosthetic stem 5a-5e and reference mark (therefore each pair of prosthetic stem - degree of sinking) corresponds uniquely to a position of the head center which is defined by a combination of a rasp 2a-2q with a test neck 3a-3g and with a test head 4a-4d.
  • the surgeon after having identified the correct position of the head center in the adjustment step by empirically trying out various combinations of rasps 2a-2q, test necks 3a-3g and test heads 4a-4d, can implant the prosthesis by positioning the head center of the prosthetic head exactly at the correct position (identified in the adjustment step) simply by implanting the corresponding prosthetic stem 5a-5e with the corresponding degree of sinking identified by the corresponding reference mark 52.
  • the kit comprises a guiding wire 80 which is fixed to a diaphyseal plug 88 which is fixed, in a known manner, to the end of the contoured portion of the diaphyseal canal D and the function of which is to seal the diaphyseal canal D and prevent the cement from propagating to the rest of the diaphyseal canal during the insertion and pressurization of the stem 5a- 5e.
  • the diaphyseal plug 88 can be made, for example, of polyethylene or titanium or of biodegradable components and is preferably provided with circumferential fixing tabs for adhering to the internal wall of the diaphyseal canal D.
  • the prosthetic stems 5a-5e are provided with an apical through canal 58, which is provided at the apex of the diaphyseal portion 54 of the prosthetic stem 5a-5e, and is adapted to be passed through by the guiding wire 80.
  • the apical through canal 58 has an inlet hole positioned on the apex of the diaphyseal portion 54 of the prosthetic stem 5a-5e and an exit hole positioned laterally, also on the diaphyseal portion 54 of the prosthetic stem 5a-5e.
  • the guiding wire 80 is thus configured to guide the insertion of the prosthetic stem 5a-5e into the diaphyseal canal D up until the center of the diaphyseal plug 88.
  • the guiding wire 80 is conveniently flexible, not rigid, and preferably is made of plaited fibers of polyethylene or of PMMA (polymethyl methacrylate).
  • Figures 13 and 14 show an additional embodiment of the invention in which a centering device 100 is accommodated on the bottom of the diaphyseal canal and adapted to accommodate the prosthetic stem when this is inserted into the diaphyseal canal, so as to center it conveniently.
  • a plurality of test sets are identified, each one of which comprises: one and only one rasp 2a-2q, one and only one test neck 3a-3g and one and only one test head 4a-4d.
  • Each test set is distinguished by a position of the head center which is provided by inserting such rasp 2a-2q into the diaphyseal canal D and coupling such test neck thereto and, to this, such test head.
  • each set corresponds for example to one of the points shown in the tables in Figure 11 (and indicated with a circle).
  • test sets comprise all the possible combinations of each rasp 2a-2q with each test neck 3a-3g and with each test head 4a-4d.
  • a plurality of implant sets are further identified, each one of which comprises: one and only one prosthetic stem 5a-5e, one and only one degree of sinking (corresponding to a respective reference mark 52) and one and only one prosthetic head.
  • Each implant set is distinguished by a position of the head center which is provided by inserting such prosthetic stem into the diaphyseal canal D with such degree of sinking and coupling such prosthetic head thereto.
  • the implant sets comprise all possible combinations of each prosthetic stem 5a-5e with each degree of sinking and with each prosthetic head.
  • test sets are uniquely associated with respective implant sets (a single prosthetic set associated with a single implant set), so that each test set is associated with an implant set that has the same position of the head center.
  • each prosthetic stem 5a-5e i.e. each set comprising that prosthetic stem
  • three different rasps 2a- 2q i.e. the sets comprising those three rasps
  • those three rasps are associated only with one prosthetic stem (i.e. with the sets comprising that prosthetic stem) and more precisely with the prosthetic stem that has the dimensions compatible with insertion into the diaphyseal canal D that was modeled using such three rasps 2a-2q.
  • the femur F is prepared using known procedures which comprise the removal of the head of the femur F and the preliminary preparation of the diaphyseal canal D.
  • the method then comprises an adjustment step in which, as the first substep, the surgeon chooses the rasp 2a-2q to use, as a function of the anatomy of the femur F, the surgeon's own ability, and the degree of sinking.
  • the surgeon chooses the best position of the head center, as a function of the correct joint center, and identifies the test set that provides such position of the head center, by trying to couple one or more combinations of test necks 3a-3g and of test heads 4a-4d to the inserted rasp 2a-2q.
  • the surgeon identifies the implant set associated with it (which provides the same position of the head center) and proceeds to the implantation step in which, after having removed the rasp 2a-2q from the diaphyseal canal D, the prosthetic stem 5a- 5e of the identified prosthetic set is implanted therein, with the degree of sinking of the identified prosthetic set, and couples the prosthetic head, again of the identified prosthetic set, thereto so that the prosthetic head has a position of the head center that is the same as the one that was correctly identified in the adjustment step.
  • a prosthetic stem 5a-5e with one or more rasps 2a-2q which are configured to provide a channel for stems of smaller dimensions, i.e., in practice, a prosthetic stem 5a-5e can be inserted into a diaphyseal canal D that was prepared with a rasp 2a-2q of smaller size, thus obtaining a different positioning of the prosthetic stem 5a-5e and therefore further positions of the head center; such possibilities are, in practice, limited by the problem of reducing the thickness of the cement.
  • the diaphyseal canal D is filled with the cement, then the identified prosthetic stem 5a-5e is inserted into the diaphyseal canal D, making it sink into the cement until the reference mark 52 that corresponds to the identified degree of sinking coincides with a predetermined reference element on the femur F (for example the upper edge of the femur F).
  • a guiding wire 80 is fixed with one end to the diaphyseal plug 88 which is fixed to the end of the contoured portion of the diaphyseal canal D.
  • the other end of the guiding wire 80 is made to protrude from the proximal opening of the diaphyseal canal D (at the metaphysis of the femur F); then, after having filled the diaphyseal canal D with the cement, the guiding wire 80 is inserted into the special apical through canal 58 provided at the apex of the diaphyseal portion 54 of the prosthetic stem 5a-5e and then, by sliding the prosthetic stem 5a-5e along the guiding wire 80, the prosthetic stem 5a-5e is guided inside the diaphyseal canal D up until the center of the diaphyseal plug 88.
  • the identified prosthetic head is fixed to the engagement portion 59 of the neck portion 55 of the prosthetic stem 5a- 5e.
  • the prosthesization operation can then be concluded in a known manner
  • the kit of orthopedic surgical devices achieves the intended aim and objects in that it makes the correct reconstruction of the anatomy of the patient simpler and less dependent on the abilities of the surgeon, while at the same time retaining the advantages of using cement.
  • kit of orthopedic surgical devices consists in that it makes it possible to correctly position the head center of the prosthesis via a standardized procedure.
  • kit of orthopedic surgical devices consists in that it makes it possible to provide an implant procedure that makes it possible to reconstruct the anatomy of the patient in a simpler and more precise manner
  • kit of orthopedic surgical devices consists in that it makes it possible for the surgeon to have objective reference points during the implant procedure.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Dentistry (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un kit de dispositifs chirurgicaux orthopédiques, pour la fourniture d'un implant de prothèse fémorale cimenté, qui comprend au moins une râpe (2) pour mettre en forme le canal diaphysaire (D) d'un fémur (F) et au moins une tige prothétique (5), et comprenant en outre : - une pluralité de tiges prothétiques (5a-5e) qui présentent des dimensions mutuellement différentes, - pour chacune des tiges prothétiques (5a-5e) une pluralité de râpes (2a-2q), qui présentent des dimensions mutuellement différentes, - une pluralité de cols de test (3a-3g), qui présentent des formes et/ou des dimensions mutuellement différentes, - une pluralité de têtes de test (4a-4d) qui sont pourvues d'un moyen d'accouplement amovible (41) qui permet l'accouplement de manière amovible de chacune des têtes de test (4a-4d) à chacun des cols de test (3a-3g).
PCT/EP2020/058956 2019-07-10 2020-03-30 Kit de dispositifs chirurgicaux orthopédiques pour la fourniture d'un implant de prothèse fémorale cimenté WO2021004663A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102019000011313A IT201900011313A1 (it) 2019-07-10 2019-07-10 Kit di presidi chirurgici ortopedici per la realizzazione di un impianto di protesi di femore cementata.
IT102019000011313 2019-07-10

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113425468A (zh) * 2021-06-24 2021-09-24 北京市春立正达医疗器械股份有限公司 一种铰链套筒式指关节假体

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04170948A (ja) * 1990-11-02 1992-06-18 Dow Corning Wright Corp 前傾を調節できるモジュール型人工股関節
WO2000072784A1 (fr) * 1999-06-01 2000-12-07 Apex Surgical, Llc Protheses articulaires pouvant etre implantees
US20020116005A1 (en) * 2000-11-15 2002-08-22 Storer John Andrew Prosthetic implant cement deflector and method of implantation
WO2008098171A2 (fr) * 2007-02-09 2008-08-14 Zimmer, Inc. Implants de hanche prothétiques
EP2027833A1 (fr) * 2007-08-22 2009-02-25 Benoist Girard Sas Composant de prothèse de cou d'essai
EP2386273A1 (fr) * 2010-05-12 2011-11-16 Smith & Nephew Orthopaedics AG Prothèses d'articulation coxo-fémorale améliorées

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04170948A (ja) * 1990-11-02 1992-06-18 Dow Corning Wright Corp 前傾を調節できるモジュール型人工股関節
WO2000072784A1 (fr) * 1999-06-01 2000-12-07 Apex Surgical, Llc Protheses articulaires pouvant etre implantees
US20020116005A1 (en) * 2000-11-15 2002-08-22 Storer John Andrew Prosthetic implant cement deflector and method of implantation
WO2008098171A2 (fr) * 2007-02-09 2008-08-14 Zimmer, Inc. Implants de hanche prothétiques
EP2027833A1 (fr) * 2007-08-22 2009-02-25 Benoist Girard Sas Composant de prothèse de cou d'essai
EP2386273A1 (fr) * 2010-05-12 2011-11-16 Smith & Nephew Orthopaedics AG Prothèses d'articulation coxo-fémorale améliorées

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113425468A (zh) * 2021-06-24 2021-09-24 北京市春立正达医疗器械股份有限公司 一种铰链套筒式指关节假体

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