EP3386442A1 - Dispositif prothétique pour le corps humain et procédé pour sa production - Google Patents

Dispositif prothétique pour le corps humain et procédé pour sa production

Info

Publication number
EP3386442A1
EP3386442A1 EP16831717.0A EP16831717A EP3386442A1 EP 3386442 A1 EP3386442 A1 EP 3386442A1 EP 16831717 A EP16831717 A EP 16831717A EP 3386442 A1 EP3386442 A1 EP 3386442A1
Authority
EP
European Patent Office
Prior art keywords
prosthetic device
prosthetic
filler material
bone
pharmaceutical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16831717.0A
Other languages
German (de)
English (en)
Inventor
Augusto MAGAGNOLI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cossington Ltd
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP3386442A1 publication Critical patent/EP3386442A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61F2/38—Joints for elbows or knees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • 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
    • 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
    • A61F2/32—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
    • A61F2/38—Joints for elbows or knees
    • A61F2/3859—Femoral components
    • 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
    • A61F2/38—Joints for elbows or knees
    • A61F2/389—Tibial components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • A61F2002/3068—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body the pharmaceutical product being in a reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30769—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth madreporic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30795—Blind bores, e.g. of circular cross-section
    • A61F2002/30805—Recesses of comparatively large area with respect to their low depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3082—Grooves
    • A61F2002/30822—Circumferential grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30899—Protrusions pierced with apertures
    • A61F2002/30901—Protrusions pierced with apertures longitudinally
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30899—Protrusions pierced with apertures
    • A61F2002/30902—Protrusions pierced with apertures laterally or radially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
    • A61F2002/30909—Nets
    • 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
    • A61F2002/3678—Geometrical features
    • A61F2002/368—Geometrical features with lateral apertures, bores, holes or openings, e.g. for reducing the mass, for receiving fixation screws or for communicating with the inside of a hollow shaft

Definitions

  • the present invention regards a prosthetic device, capable of being permanently implanted in a bone or articulation site of a patient, for treating a bone lesion or a bone fracture and for the prevention and/or treatment of an infection that can arise or that has arisen in the bone or articulation site of the human body.
  • the present invention refers to a method for making a prosthetic device, capable of being implanted in a bone or articulation site of a patient, for treating a bone lesion or a bone fracture and for the prevention and/or treatment of an infection that can arise or that has arisen in the bone or articulation site of the human body.
  • the prosthesis can in fact be reached by bacteria present in the implant site or in the surgical environment, which colonize the surface thereof, involving the unsticking of the prosthesis from the bone or articulation site.
  • the steps to be followed for defeating such infection provide for the removal of the infected prosthesis from the implant site, the implanting of a spacer loaded with antibiotic or capable of releasing antibiotic and, finally, when the infection has been totally defeated, the installation of a new prosthesis.
  • spacer devices are necessary in order to maintain substantially unaltered the shape of the bone site or articulation site in which the new prosthesis will be implanted, as well as in order to defeat the ongoing infection thanks to the release of antibiotics.
  • This procedure is the re-prosthetization procedure known as "two stages” or “at two times", because the healing from the infection and the implant of a new prosthesis require two implant/treatment steps.
  • a spacer during the "two stages" or “at two times” procedure involves the presence of several bone requirements, such as the need to have an articulation in which the ligaments are substantially integral, in a manner such that the spacer is stable once implanted, and in which the corresponding bone part has not been excessively resected, in a manner such that after the step of implant and removal of the spacer device, it is possible to fix the new prosthesis in a correct and stable position.
  • the patent US5549699 describes an acetabular cup of a prosthesis provided with depressions that are filled with ground bone tissue, in order to rectify the bone loss of the support bone and thus prevent the migration of the acetabular cup itself.
  • Such patent also describes a femoral stem of a hip prosthesis provided with recesses in which the ground bone tissue is compressed, in order to have an improved interface surface between prosthesis and bone.
  • the patent US62451 1 1 describes a temporary spacer device which is unable to support the weight of the patient in which it is implanted.
  • Such device comprises an internal skeleton which is formed, for example by means of the use of a suitable mold, with antibiotic-loaded bone cement, in order to treat the infection underway at the implant site.
  • the patent application US2010/0042214 describes an orthopedic implant, in particular a temporary implant, provided with a tank and with channels that allow delivering, towards the tissue of the patient, at least one therapeutic agent contained in the tank. The therapeutic agent is inserted in the tank before and/or after the implant.
  • the patent application US2007/0016163 describes a device adapted to be inserted in a canal or in an empty space of a bone tissue, comprising a number of tanks, for example micro-tanks, which contain a drug selected from among growth promoters, angiogenic promoters, analgesics, antibiotics and combinations thereof.
  • Such device can be a monolithic structure, e.g. cylindrical, or it can be in the form of multiple units, e.g. a plurality of balls. Also the bone prostheses can be part of these devices.
  • the task of the present invention is to improve the state of the prior art.
  • one object of the present invention is to provide a prosthetic device capable of preventing and/or treating an infection that can arise or that has arisen in a bone or articulation site of the human body.
  • a further object of the present invention is to provide a prosthetic device for releasing at least one pharmaceutical or medical substance for long periods of time and in specific portions in the bone or articulation site of the human body with which it is associated.
  • a further object of the present invention is to provide a prosthetic device that can be of either first-implant or revision.
  • Another object of the present invention is that to provide a first-implant antibiotic-loaded prosthetic device that clearly- reduces the risk of post- operation infection of the bone or articulation site, thus preventing the need for a re-prosthetization by means of a "one stage” or "two stage” surgical procedure.
  • a prosthetic device is provided, according to claim 1.
  • figure 1 is a top perspective view of one version of the prosthetic device according to the present invention.
  • figure 2 is a bottom perspective view of the lower portion of the prosthetic device pursuant to figure 1 ;
  • figure 3 is a bottom perspective view of a further embodiment of the lower portion of the prosthetic device pursuant to figure 1 ;
  • figure 4 is a top perspective view of a further embodiment of the prosthetic device according to the present invention.
  • figure 5 is a top perspective view of an acetabular portion or version of the prosthetic device according to the present invention.
  • figure 6 is a sectional perspective view of the acetabular portion or version of the prosthetic device pursuant to figure 5;
  • figure 7 is a perspective view of a further embodiment of the prosthetic device according to the present invention.
  • figure 8 is a perspective view of the prosthetic device pursuant to figure 7 according to another angle.
  • the prosthetic device according to the present invention is usable both as a first-implant prosthesis and as a revision prosthesis.
  • Such prosthetic device is of permanent type.
  • provision prosthesis it is intended that such prosthetic device can be inserted following the explant of an infected prosthetic device, i.e. in a "one stage” surgical procedure, or after the removal of a spacer, in a "two stages” procedure.
  • such case can occur when the doctor deems that, notwithstanding the sanification of the site thanks to the spacer, the patient still remains at risk of re-infection, thus deciding to extensively use the final prosthesis loaded with antibiotic or provided with pharmaceutical or medical substances according to the present invention.
  • the prosthetic device according to the present invention is in fact a final prosthesis.
  • the prosthetic device can remain indefinitely in the human body, and be removed from the same only in exceptional circumstances (such as accidental breakage or other causes linked to the health of the patient).
  • the prosthetic device performs the function of a standard prosthesis but, additionally, allows preventing the onset of a post-operation infection in the bone or articulation site and/or the treatment of such site if the infection is already underway.
  • the prevention or treatment action occurs due to the release, by the prosthetic device, of at least one pharmaceutical or medical substance in the implant or infected zone.
  • the prosthetic device according to the present invention allows the release of such at least one pharmaceutical or medical substance, for example in infinitesimal amounts, for a prolonged time period: in this manner, the bone or articulation site in which the implant occurs of the device itself, or the site to be treated, can absorb all the particles of the at least one pharmaceutical or medical substance released daily by the device, thus obtaining improved prevention and/or healing against infections. In such a manner, the risk of onset of such infections is in fact quite limited.
  • the configuration of the prosthetic device is such to allow the release of the at least one pharmaceutical or medical substance, possibly in infinitesimal quantities, in contact with or next to the bone or articulation site of implant or to be treated, such that the process of absorption of such substances is efficient.
  • the configuration of the prosthetic device according to the invention is such to be substantially complementary to the shape of the bone or articulation site of implant or to be treated.
  • the prosthetic device can comprise a tibial portion of a knee prosthesis (as illustrated in figures 1 -3), a femoral portion of a knee prosthesis (as illustrated in figure 4), an acetabular portion of a hip or shoulder prosthesis (as shown in figures 5 and 6), a stem portion of a hip or shoulder prosthesis (as illustrated in figures 7 and 8) or a bone prosthesis in general.
  • the prosthetic device according to the present invention is made of a material that is biologically-compatible with human tissues.
  • a material that is biologically-compatible with human tissues.
  • such material can be a metal, a metal alloy, an organo-metallic compound, a ceramic or a combination thereof.
  • the biologically-compatible material can comprise or be at least partially covered with acrylic resin, plastic material, ceramic material, resin with high porosity, bone cement or polymethylmethacrylate (PMMA), thermoplastic polymers, polyethylene, polypropylene, polyester, thermoforming polymers, or a combination thereof or other similar materials
  • the coating can cover, in one version of the invention, only some portions of the prosthetic device, generally those most subjected to rubbing or those in direct contact with the bone tissue of the patient.
  • the portions most subjected to wear can have a coating which confers greater hardness thereto; such coating can be obtained by means of deposition or application of at least one metal oxide and/or nitride, e.g. titanium nitride.
  • the coating can cover the entire surface of the prosthetic device adapted to be positioned, during use, in contact with the bone tissue of the patient.
  • the possible coating for example formed by the filler material 4' as better described hereinbelow, will have a pre-determined thickness, e.g. uniform, and will substantially cover the entire surface of the prosthetic device in contact with the bone tissue.
  • the coating will cover a surface having shape corresponding to that of the bone or articulation site to be treated and, therefore, also the coating, in the thickness thereof, will have shape corresponding to that of the bone or articulation site to be treated.
  • the prosthetic device according to the present invention comprising a tibial component of a prosthesis for the knee joint is indicated overall with reference number 1.
  • the prosthetic device 1 comprises at least one prosthetic body 2.
  • Such prosthetic body 2 has a shape substantially complementary to that of the bone or articulation site in which it has to be implanted, or in any case to be treated.
  • the prosthetic body 2 comprises a tibial plate component and, possibly, a stem component S.
  • the stem S has a substantially tubular shape while the tibial plate component 20 has a substantially flat and "C" shape, considering its section along a transverse plane of the human body.
  • the positioning of the prosthetic device 1 in the bone or articulation site is precise and the obtained performances are optimal.
  • the prosthetic device 1 is adapted to be constrained to the tibial end of the knee joint.
  • the stem S is adapted to be inserted within the tibial medullary canal, at the knee joint.
  • Such stem S is hollow and internally has a cavity H; the stem S also comprises holes F, passing through the wall of the stem S itself, adapted to deliver at least one pharmaceutical or medical substance, contained in the cavity H of the stem S or in a filler material 4' contained in the cavity H, towards the implant site of the prosthetic device 1 or towards the site or bone tissue to be treated.
  • Such pharmaceutical or medical substance can be inserted within such stem S by means of an opening A, of greater size than the holes F, placed at the stem itself.
  • Such opening A is placed, in particular, in the distal end S I of the stem S, adapted during use to be inserted in the tibial medullary canal at the knee joint.
  • the prosthetic body 2 is provided with at least one coupling surface 3 adapted to come into contact with the bone or articulation site to be treated.
  • the opening A is placed in continuity with the cavity H of the stem S.
  • Such coupling surface 3 is substantially complementary to the bone or articulation site of the patient, such that the positioning and connection of the prosthetic device 1 in/to the bone or articulation site is correct.
  • the coupling surface 3 is, during use, completely in contact with the bone tissue.
  • the coupling surface 3, as shown in figures 1 -3, is shaped in a manner such to allow the coupling of the prosthetic body 2 to the tibial end, at the knee joint.
  • the prosthetic body 2, in particular the coupling surface 3, has at least one cavity 4.
  • such cavity 4 is a groove or a slot.
  • such at least one cavity has a substantially polyhedron or parallelepiped shape, e.g. cubic or parallelepiped with rectangular base, or rectangular parallelepiped, in which only one face of such shape is delimited by an opening, as will be better described hereinbelow.
  • such at least one cavity 4 has a plan dimension or a side dimension greater than its depth inside the prosthetic device 1.
  • Such at least one cavity 4, is adapted to comprise, contain or house a filler material 4' .
  • the coupling surface 3 can be totally covered with filler material 4' .
  • the coupling surface 3 comprises a filler material 4' coating placed at and in contact with the entire coupling surface 3 itself.
  • the stem S comprises a filler material 4' coating placed at and in contact with the entire surface of the stem S itself, surface adapted to be placed during use in contact with the bone tissue of the patient.
  • the coating of filler material 4' must have, in one version of the invention, a hard and/or compact consistency.
  • porous ceramic, terracotta, plastic materials or materials with hard consistency are capable of ensuring a certain strength.
  • the filler material 4' and/or the coating is porous or comprises small channels, in a manner such that the prosthetic device 1 , once immersed in a medicated solution or a solution containing a pharmaceutical or medical substance, is capable of being impregnated therewith.
  • the presence of pores or small channels allows the prosthetic device 1 to release at least one pharmaceutical or medical substance for the treatment, prevention or healing of a bone or articulation site of the human body.
  • Such filler material 4' can be in solidifiable fluid form or in solid form.
  • the filler material 4' has a semi-solid form, e.g. gel form.
  • the filler material 4', placed in the at least one cavity 4, is hardened.
  • the filler material 4' occupies the entire space corresponding with the at least one cavity 4 and hence completely fills it.
  • the filler material 4' occupies the entire coupling surface 3 adapted to be placed during use in contact with the bone tissue of the patient.
  • the use of filler material 4' at least partially ensures the restoration of the mechanical as well as geometric properties of a prosthetic device of conventional type.
  • the filler material 4' comprises or can be admixed with at least one pharmaceutical or medical substance.
  • such filler material 4' can be, at the start, without pharmaceutical or medical substances, in a manner such that at least one pharmaceutical or medical substance can be admixed with the filler material itself during the surgical step (also based on the needs of the patient and the state of the encountered infection).
  • the filler material 4' can comprise at least one pharmaceutical or medical substance, in a manner such that such material 4' can be inserted within the cavity/cavities 4 without having to add any substance necessary for treating the infection (possibly, for specific needs, such filler material 4' can be admixed with further substances, in addition to those already comprised therein).
  • the at least one pharmaceutical or medical substance, such as an antibiotic can already be present in the filler material 4' (which is porous), when the latter is already situated in the at least one cavity 4 of the prosthetic device according to the present invention (e.g. such placing of the material 4' in the at least one cavity of the prosthetic device does not occurs in the surgery room but at the manufacturer during the production thereof).
  • a first antibiotic such as Gentamicin
  • a second antibiotic such as Vancomycin
  • such filler material 4' can comprise at least one pharmaceutical or medical substance or it can be admixed with such substances.
  • such filler material 4' can comprise at least one from among the following materials: acrylic resin, composite material comprising calcium phosphate or an inorganic salt, calcium sulphate, bioglass, polyvinyl alcohol, or a mixture thereof.
  • the filler material 4' can comprise absorbent material, for example silk thread, cotton thread or biocompatible plant fiber, or a fabric or a non-woven fabric capable of absorbing and being impregnated with at least one pharmaceutical or medical substance, e.g. antibiotic.
  • absorbent material for example silk thread, cotton thread or biocompatible plant fiber, or a fabric or a non-woven fabric capable of absorbing and being impregnated with at least one pharmaceutical or medical substance, e.g. antibiotic.
  • such filler material 4' comprises a biocompatible semisolid material which comprises a pharmaceutical or medical substance, such as an antibiotic.
  • the semi-solid material can be insoluble (e.g. bone cement) or soluble (e.g. animal collagen, sugars, cellulose, etcetera).
  • such filler material 4' can be porous or comprise pores or small channels. Such pores must have size suitable for preventing bone growth within the material itself.
  • such porosity is arranged in a random manner.
  • such porosity is implicitly made during the formation or making of the filler material 4'.
  • the filler material 4' can coincide with the material constituting the prosthetic body 2.
  • the filler material 4' is non-biodegradable or non-soluble or permanent while the at least one pharmaceutical or medical substance is soluble or can be eluable from the filler material 4'.
  • the at least one pharmaceutical or medical substance can have liquid, fluid and/or viscous or solid form.
  • the filler material 4' has, substantially for its entire volume, a plurality of small channels with dimensions of the micrometer order (if it is considered the dimension that is perpendicular to that of greater extension of the small channel itself).
  • Such small channels can absorb and elute liquids via capillarity.
  • the small channels are interconnected with each other.
  • such small channels and/or such pores can have average size in cross section of about 100 micron.
  • the finer the porosity the greater the capillary action and hence the higher the quantity of pharmaceutical or medical substance or of antibiotic solution that is absorbed.
  • a porosity less than 100 micron would be ideal, within which the migration of the bone is insignificant.
  • the filler material 4' comprises an acrylic resin and an inorganic salt, e.g. PMMA (polymethylmethacrylate) and calcium phosphate or tri-calcium phosphate (TCP).
  • PMMA polymethylmethacrylate
  • TCP tri-calcium phosphate
  • the prosthetic device further comprises an articulation surface.
  • Such articulation surface is smooth; such articulation surface therefore lacks cavity or coating and hence lacks the filler material 4' .
  • the prosthetic device according to the present invention in at least one version thereof, while being at least partially porous, prevents the bone tissue from growing at its interior, both with regard to its porous zones and with regard to its possible non-porous zones.
  • the bone tissue can be left to grow or migrate within the porosity of the filler material 4' and within the material that constitutes the prosthetic device itself.
  • the bone growth or migration is allowed in the porosity of the material that constitutes the prosthetic device and not in the filler material 4' or vice versa it is allowed within the porosity of the filler material 4' and not in the porosity of the material that constitutes the prosthesis itself.
  • the prosthetic device has a plurality of cavities 4 placed along the coupling surface 3.
  • the depth of the cavities 4 within the prosthetic body 2 can be variable with respect to each other within a same device 1.
  • the positioning of the cavities 4, their number and their shape can vary as a function of specific requirements.
  • the size of the cavities 4 can in any case also be variable as a function of the size of the prosthetic body 2.
  • Each cavity 4 constitutes a corresponding opening 5 that extends through the coupling surface 3.
  • some cavities 4 can have elements C adapted to allow the identification of the correct positioning of the prosthetic device 1 in the bone or articulation site.
  • elements C adapted to allow the identification of the correct positioning of the prosthetic device 1 in the bone or articulation site.
  • the at least one cavity 4 acts as a housing for a filler material 4'. Indeed, within at least one opening 5 or only in some openings 5 and/or inside at least one cavity 4 or only in some cavities 4, if there are a plurality of cavities 4 in the prosthetic body 2, a filler material 4' is comprised, contained or housed, which can comprise at least one pharmaceutical or medical substance which is released inside the human body of the patient.
  • the filler material 4' is prepared and positioned in the cavity/cavities 4 by the surgeon before the implant of the prosthetic device itself, i.e. during the operation procedure.
  • the present invention confers this further advantage, verifiable by the surgeon only at the time of implant, when he/she - after the surgical opening - directly examines the conditions of the tissues of the implant site and hence the real needs of the patient.
  • the prosthetic device 1 has configuration such to ensure that the filler material 4' is in contact with the bone or articular tissues to be treated or of implant; consequently, such filler material 4' fills such cavity 4 such to be flush with the coupling surface 3 or projecting with respect to such coupling surface 3. In such a manner, a surface continuous with the coupling surface 3 of the prosthetic body 2 is obtained.
  • the overall volume occupied by the at least one cavity 4 can vary, such that the prosthetic device 1 can ensure the release of at least one pharmaceutical or medical substance for the entire selected period.
  • the prosthetic device 1 at the coupling surface 3, comprises a cavity 4 of size substantially corresponding with that of the coupling surface 3 itself: such cavity 4 is filled with the filler material 4'.
  • the configuration of the cavities 4 can be such to define an open-cell structure
  • the open-cell structure 6 comprises a plurality of cells placed next to each other, each of which corresponding to a cavity 4.
  • the open cells 6 or the cavities 4 are separated from each other by ribs 7.
  • Such ribs 7 represent walls interposed between the cavities 4 themselves or between the cells 6 themselves, which allow a physical division of the spaces defined by such cavities 4 or cells 6.
  • the ribs 7 or at least one rib 7 determines the perimeter of the cavities 4 or of the open cells 6.
  • the ribs 7 project upward in a substantially perpendicular manner from an internal wall of the open cells 6 or of the cavities 4.
  • the ribs 7 constitute the perimeter sides of the cells 6 or of the cavities 4, and delimit a flat base.
  • the base opposite such flat base is affected by the opening 5.
  • the cells 6 are therefore perimetrically closed cells that are only open at the coupling surface 3.
  • the ribs 7 can also act as reinforcement elements for the prosthetic body 2. Based on this further function of the ribs 7, the cavities 4 can have a positioning such to ensure the presence of the ribs 7 at the portions of the prosthetic device 1 which, during use, are subjected to greater mechanical stresses, e.g. wear, bending, fatigue, etc.
  • cavities 4 or cells 6 contain filler material 4' that is different from one cavity to another, or a material 4' containing at least one pharmaceutical or medical substance that is different from one cavity to another. In this manner, it is possible to carry out a preventative or curative treatment that is differentiated for the different areas of the bone or articulation site.
  • some or all the cavities 4 or cells 6 can be in communication with each other, e.g. by means of perforations placed at the ribs 7.
  • the distance along with the mutual positioning between the single cavities 4 can vary.
  • the prosthetic body 2 can be associated with an insert 3'.
  • Such insert 3' can be made of plastic or polymer material, such as polyethylene, polypropylene, polyester, and other similar materials.
  • the insert 3' is made of a material capable of facilitating the sliding or articulation with a further prosthetic component or with the bone tissue of the patient, at the specific joint or implant site.
  • polyethylene UHMWPE can be used, which is a low-friction material.
  • Such insert 3' in one version of the invention, is positioned on the prosthetic body 2 in an opposite position with respect to the coupling surface 3, which comes into contact with the bone or articulation site.
  • the insert 3' and the prosthetic body 2 can have a variable positioning with respect to each other, in accordance with the shape of the prosthetic device itself.
  • the insert 3' may possibly have at least one further cavity.
  • FIG 4 a further embodiment is illustrated of a prosthetic device that during use can be constrained to the femoral end of the knee joint; such device is indicated overall with the reference number 100.
  • the prosthetic device 100 overall differs from the preceding prosthetic device, indicated with number 1 , only due to its configuration, since such device 100 represents a prosthesis associable with the lower end of the femur, at the knee joint.
  • the prosthetic device 100 is adapted, in one version of the invention, to be articulated during use with the prosthetic device 1 , or better yet with its possible insert 3'.
  • the prosthetic device 100 comprises a prosthetic body 102 in turn comprising at least one surface 103 for coupling, during use, with the femoral bone end at the knee joint.
  • the prosthetic body 102 has a substantially "U" shape, considering a section thereof taken along a plane parallel to the sagittal plan of the human body.
  • the coupling surface 103 corresponds with the concave surface of the prosthetic body 102.
  • the prosthetic body 102 or better yet its coupling surface 103, comprises at least one cavity 104.
  • the at least one cavity 104 determines a respective opening 105, which is extended along and/or through the at least one coupling surface 103.
  • each cavity 104 can comprise, contain or house a filler material 4'.
  • the shape, volume and arrangement of the single cavities 104 can vary, for example based on the shape of the prosthetic body 102.
  • the configuration of such cavities 104 or openings 105 is an open-cell 6 configuration.
  • the prosthetic device 100 comprises an articulation surface 103' opposite the coupling surface 103.
  • the articulation surface 103' corresponds with the convex surface of the prosthetic body 102.
  • Such articulation surface 103' is adapted to be associated, in an articulated manner, with the tibial portion of the knee joint or with the articulation surface or with the insert 3' of the prosthetic device 1.
  • the articulation surface 103' may possibly house further cavities, not shown in figure 4.
  • the characteristics of the cavities 104, of the material 4', of the cells 6 and of the openings 105 correspond with those previously described for the prosthetic device 1.
  • the prosthetic device comprises a cotyloid or an acetabular portion of a hip or shoulder prosthesis.
  • the prosthetic device 200 comprises a prosthetic body 202.
  • Such embodiment has the same characteristics described for the previous embodiments, but varies regarding configuration since the implant site is different from that of the prosthetic devices 1 and 100.
  • the prosthetic body 202 has a dome-like or hemisphere-like configuration.
  • the prosthetic body 202 subtends an empty space or concavity V.
  • the empty space or concavity V has a hemispherical shape and is adapted to house during use a head of a hip or shoulder prosthesis or the bone portion of the head of the femur or of the shoulder bone, given that they are substantially complementary thereto.
  • the prosthetic body 202 during use, is adapted to be positioned and/or fixed in/to the acetabular or cotyloid cavity which is present at the human pelvis or the shoulder joint.
  • the prosthetic body 202 comprises a coupling surface 203 and an internal or articulation surface 203' opposite the coupling surface 203.
  • the coupling surface 203 is convex, corresponds with the convex surface of the prosthetic body 202 and is adapted to come into contact with the bone of the patient.
  • the internal surface 203' is concave, corresponds with the concave surface of the prosthetic body 202 and is instead adapted to make the articulation of the corresponding bone site.
  • the concavity of the articulation surface 203' corresponds with the empty space or concavity V.
  • An articular insert not illustrated in the figures, made of material of various types, e.g. ceramic or polyethylene, can be positioned in contact with the internal surface 203', in a manner such to decrease the friction caused by the articulation.
  • the coupling surface 203 comprises one or at least one cavity 204.
  • the at least one cavity 204 can have variable volume, configuration and/or arrangement in accordance with the geometry of the prosthetic body 202 and in accordance with the requirements.
  • the at least one cavity 204 can assume the configuration of at least one annular groove.
  • Such grooves can be arranged at a constant distance from each other. Such grooves can be positioned in a concentric manner and parallel to a diameter or to a base of the prosthetic body 202. In such case, the cavities 204 have an annular opening 205 at the coupling surface 203; for the remaining features, the cavities 203 are grooves that are extended for a specific depth inside the material that constitutes the prosthetic body 202.
  • the at least one cavity 204 is arranged in a nonuniform manner along the coupling surface 203; when there is more than one cavity, they can have shapes and volumes different from each other.
  • Each cavity 204 determines a corresponding opening 205 which develops through the coupling surface 203.
  • the openings 205 correspond with a space within which it is possible to house the filler material 4'.
  • the coupling surface 203 can comprise a coating of filler material 4', of analogous size with respect to that of the coupling surface itself.
  • a prosthetic device 300 comprises a prosthetic body 302 which has a stem-like shape.
  • the prosthetic body 302 has an elongated shape and is adapted to constitute the stem of a hip or shoulder prosthesis.
  • the prosthetic device 300 can comprise, in the version relative to a hip prosthesis, a head corresponding to the femoral head of the hip joint, adapted to be articulated with the cotyloid of a patient or with the prosthetic device 200.
  • the prosthetic body or stem 302 comprises an end E.
  • the end E represents the 25 proximal end of the prosthetic body 300, adapted to be coupled with the head of the prosthesis, when present.
  • the prosthetic body 300 comprises a distal end E', opposite during use with respect to the end E.
  • the distal end E' is adapted to be implanted within the femoral medullary canal or in the shoulder bone of the patient.
  • the proximal end E has a frustoconical shape. Such shape is however non-limiting of the present invention and the end E can also have other shapes or forms.
  • the prosthetic body 300 further comprises a connector portion R, placed at the proximal end E and adapted to connect the proximal end E with an elongated body 302' which constitutes the stem-like element of the prosthetic body 302.
  • the prosthetic body 302 or the elongated body 302' which constitutes the stem-like element comprises at least one coupling surface 303, adapted to come into contact during use with the bone tissue or the implant bone site.
  • one or at least one cavity 304 is present that is adapted to comprise, contain or house the filler material 4'.
  • the at least one cavity 304 has a groove-like shape.
  • such at least one groove has a longitudinal progression, parallel to the longitudinal axis of the elongated body 302' which constitutes the stem of the prosthetic body 302.
  • Each groove or cavity 304 identifies a respective opening 305.
  • the at least one cavity 304 has geometry, volume and/or arrangement that varies in accordance with the implant site or in accordance with requirements.
  • the cavities 304 appear as grooves or slots having an extension substantially equal to the distance from the connector portion R up to the distal end E' of the stem-like element or prosthetic body 302.
  • such cavities 304 could have a partial or zonal extension.
  • the at least one cavity 304 can be placed at the faces of greater size.
  • Such configuration is only a non-limiting example of the present invention.
  • the elongated body 302' which constitutes the stem element, comprises a coating of filler material 4' placed at and in contact with the entire surface of the stem itself, surface adapted to be placed during use in contact with the bone tissue of the patient.
  • the coating of filler material 4' must have, in one version of the invention, a hard and/or compact consistency.
  • porous ceramic, terracotta, plastic materials or materials with hard consistency i.e. materials capable of ensuring a certain strength.
  • the coating is porous or comprises small channels, in a manner such that the prosthetic device 1 , once immersed in a medicated solution or a solution containing a pharmaceutical or medical substance, is capable of being impregnated therewith.
  • the presence of pores or small channels allows the prosthetic device 300 to release at least one pharmaceutical or medical substance for the treatment, prevention or haling of a bone or articulation site of the human body.
  • the invention thus conceived allows obtaining technical advantages.
  • the advantage of being able to use a prosthesis which, with respect to the conventional prostheses, allows a prevention and/or a treatment of the bone or articular infections, without having to intervene with a one-stage or two-stage treatment.
  • a prosthetic device is obtained with mechanical characteristics comparable to those of the standard prostheses.
  • the presence of cavities which can be independent from each other allows arranging a prosthetic device capable of releasing more than one type of pharmaceutical or medical substance in the bone or articulation site to be treated.
  • the present invention then regards a method for making a prosthetic device 1 , 100, 200, 300.
  • Such method provides for the steps of obtaining a prosthetic body 2, 102, 202, 302 having a shape substantially complementary to that of the bone or articulation site of implant or to be treated and provided with at least one cavity 4, 104, 204, 304, of providing at least one filler material 4' comprising at least one pharmaceutical or medical substance or admixable with at least one pharmaceutical or medical substance, of inserting, in the at least one cavity 4, 104, 204, 304, the at least one filler material 4'.
  • the method comprises the steps of obtaining a prosthetic body 2, 102, 202, 302 having a shape substantially complementary to that of the bone or articulation site of implant or to be treated, of providing at least one filler material 4' comprising at least one pharmaceutical or medical substance or admixable with at least one pharmaceutical or medical substance, of coating at least one coupling surface 3, 103, 203, 303 of the prosthetic body 2, 102, 202, 302 with the at least one filler material 4'.
  • the filler material 4' comprises or can be admixed with or is capable of absorbing or being impregnated with at least one pharmaceutical or medical substance. Therefore, the method can provide for immersing or impregnating the filler material 4' with the at least one pharmaceutical or medical substance. In this manner, the accumulation of the pharmaceutical or medical substance is determined in the porous material contained in the prosthesis according to the present invention. The accumulated pharmaceutical or medical substance, once the prosthesis will be implanted in the bone, will exit or elute from the prosthetic material and will enter into the periprosthetic tissues, medicating them.
  • the method can further comprise a step of waiting for the filler material 4', which can be of solidifiable type (e.g. bone cement), to harden, making a single body with the prosthetic body 2, 102, 202, 302 itself, or a step of solidifying the filler material 4', in a manner such that the filler material 4' forms a single body with the prosthetic body 2, 102, 202, 302.
  • the filler material 4' which can be of solidifiable type (e.g. bone cement)
  • the method can also provide for a step of providing at least one insert 3' and associating or fixing the insert 3' with the prosthetic body 2, 102, 202, 302, and/or positioning a possible insert 3' and coupling the insert 3 ' with the prosthetic body 2, 102, 202, 302, thus determining an articulation surface with another prosthetic component or with the bone tissue having limited friction.
  • the method can comprise the steps of arranging at least one pharmaceutical or medical substance and immersing or impregnating the prosthetic device within the at least one pharmaceutical or medical substance.
  • the prosthetic device 1 , 100, 200, 300 is during use implanted at the bone or articulation site.
  • the prosthetic device 1 , 100, 200, 300 comprises both a coating and cavities, both made with the filler material 4' .
  • the cavities 4, 104, 204, 304 have a shape such to not require a mold for their filling with the filler material 4' and for maintaining the surface of such material 4' flush with the coupling surface 3, 103, 203, 303.
  • the at least one cavity and/or the coating are placed on at least part of the coupling surface, therefore on the external surface of the prosthetic device according to the present invention.
  • the coating and/or the filler material and/or the opening of the cavities is in contact with or is "closed” by the surrounding bone tissue or by the bone cement which is used for fixing the prosthesis itself in position during implant.
  • the prosthetic device 1 , 100, 200, 300 releases, in a gradual and substantially uniform manner, the at least one pharmaceutical or medical substance present therein, at the implant site or at the site to be treated.
  • the prosthetic device 1 , 100, 200, 300 is capable of directly releasing the at least one pharmaceutical or medical substance due to the nature and/or shape and/or porosity of the filler material 4', without having to create suitable canals or slits for the release thereof.
  • the prosthetic device 1 , 100, 200, 300 is permanent.
  • such method allows obtaining, in a few simple steps, a prosthetic device capable both of preventing and treating an infection of the bone or articulation site.
  • the described method allows arranging a prosthetic device effective in preventing and treating infections of the bone or articulation site: such device in fact contains at least one pharmaceutical or medical substance, to be released at the bone or articulation site, in a manner so as to prevent the onset of an infection or to defeat it, when it is already underway.
  • the prosthetic device comprises, contains, houses or is admixable with at least one pharmaceutical or medical substance, for example at least one antibiotic.
  • at least one pharmaceutical or medical substance for example at least one antibiotic.
  • a kit comprising a prosthetic device according to the present invention and a filler material of the above- described type.
  • the prosthetic device according to the present invention is preformed.
  • a prosthetic device already provided with the filler material 4' the latter being positioned on the at least one coupling surface and/or inside the at least one cavity.
  • the preformed prosthetic device is therefore already provided with filler material when sold, and hence it is ready for use.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
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  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Prostheses (AREA)
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Abstract

La présente invention concerne un dispositif prothétique (1, 100, 200, 300), adapté pour être implanté dans le corps humain et adapté pour prévenir et/ou traiter une infection qui peut survenir et/ou qui est survenue dans un site osseux ou articulaire, le dispositif prothétique comprenant un corps prothétique (2, 102, 202, 302) pourvu d'au moins une surface pour couplage, en utilisation, avec le site osseux ou articulaire avec au moins une cavité (4, 104, 204, 304) placée le long de la surface de couplage, l'au moins une cavité étant adaptée pour comprendre, contenir ou recevoir au moins une substance pharmaceutique médicale (4').
EP16831717.0A 2015-12-10 2016-12-07 Dispositif prothétique pour le corps humain et procédé pour sa production Withdrawn EP3386442A1 (fr)

Applications Claiming Priority (2)

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ITUB2015A009763A ITUB20159763A1 (it) 2015-12-10 2015-12-10 Dispositivo protesico per il corpo umano e metodo per la sua realizzazione
PCT/IB2016/001730 WO2017098316A1 (fr) 2015-12-10 2016-12-07 Dispositif prothétique pour le corps humain et procédé pour sa production

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JP (1) JP2018536496A (fr)
KR (1) KR20180109872A (fr)
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IT (1) ITUB20159763A1 (fr)
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WO (1) WO2017098316A1 (fr)

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ITUB20152661A1 (it) * 2015-07-30 2017-01-30 Tecres Spa Dispositivo protesico antibiotato
EP3641701A4 (fr) * 2017-06-23 2021-03-17 Forcast Orthopedics, Inc. Procédé, système et appareil pour apporter un remède à un genou
DE102018106704B4 (de) 2018-03-21 2021-06-24 Heraeus Medical Gmbh Kniespacersystem mit Spülvorrichtung
EP3930634B1 (fr) * 2019-02-28 2023-10-11 Limacorporate S.p.A. Plaque de base tibiale pour composant tibial d'une prothèse de genou, composant tibial comprenant la plaque de base tibiale et procédé de fabrication de la plaque de base tibiale
IT202000007444A1 (it) * 2020-04-07 2021-10-07 Cossington Ltd Dispositivo impiantabile nel corpo umano nonché metodo di ottenimento dello stesso
US11439511B2 (en) * 2020-04-30 2022-09-13 Depuy Ireland Unlimited Company Orthopaedic knee implant system with controlled stiffness
IT202000032114A1 (it) * 2020-12-23 2022-06-23 G21 S R L Stampo per la formatura di uno spaziatore ortopedico cotilare

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JP2018536496A (ja) 2018-12-13
CN108697508A (zh) 2018-10-23
WO2017098316A1 (fr) 2017-06-15
RU2018124342A (ru) 2020-01-10
KR20180109872A (ko) 2018-10-08

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