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WO2008035198A2 - gabarit, outil et appareil pour le façonnage d'implants prothétiques - Google Patents

gabarit, outil et appareil pour le façonnage d'implants prothétiques Download PDF

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Publication number
WO2008035198A2
WO2008035198A2 PCT/IB2007/002770 IB2007002770W WO2008035198A2 WO 2008035198 A2 WO2008035198 A2 WO 2008035198A2 IB 2007002770 W IB2007002770 W IB 2007002770W WO 2008035198 A2 WO2008035198 A2 WO 2008035198A2
Authority
WO
WIPO (PCT)
Prior art keywords
template
tool
fashioning
surgeon
recess
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.)
Ceased
Application number
PCT/IB2007/002770
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English (en)
Other versions
WO2008035198A3 (fr
Inventor
Giandomenico Gonella
Marco Peretto
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.)
Comeg Tecnologie Srl
Original Assignee
Comeg Tecnologie Srl
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 Comeg Tecnologie Srl filed Critical Comeg Tecnologie Srl
Publication of WO2008035198A2 publication Critical patent/WO2008035198A2/fr
Publication of WO2008035198A3 publication Critical patent/WO2008035198A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • 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
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1664—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the hip
    • A61B17/1666—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the hip for the acetabulum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/0023—Surgical instruments, devices or methods disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
    • A61B17/025—Joint distractors
    • A61B2017/0268—Joint distractors for the knee
    • 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
    • A61F2/38—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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/3009—Transparent or translucent
    • 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
    • A61F2002/30716—Features concerning an interaction with the environment or a particular use of the prosthesis for single use, e.g. having means for preventing re-use
    • 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
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/009—Additional features; Implant or prostheses properties not otherwise provided for for single use, e.g. having means for preventing re-use
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0091—Additional features; Implant or prostheses properties not otherwise provided for transparent or translucent

Definitions

  • the present invention relates to orthopaedic surgery.
  • the invention concerns the apparatus used in orthopaedic surgery, particularly for operations involving the use of prosthetic implants.
  • the present invention relates to a template or model, a tool and an apparatus for use during surgical procedures for implanting prostheses in orthopaedic surgery, such as a hip joint prosthesis, and joint prostheses in general.
  • the method used in orthopaedic surgery and particularly the operating technique for fashioning a hip joint prosthesis, involves preparing a recess on the patient's hip bone suitable for containing a portion of the prosthesis, called the final socket, or acetabulum, in which the head of a second part of the prosthesis, attached to the limb bone, engages. More in particular, this recess is prepared by the surgeon with the aid of cutters of various shapes and using a surgical apparatus, also called the operating kit or set, comprising a set of tools.
  • kits for a hip joint prosthesis substantially comprise a series of templates of various sizes, also called test sockets, an adapter for the test head and a test head.
  • Each template or test socket comprises a shaped member that reproduces the shape of the recess to fashion on the patient's bone. More in particular, in the case of a hip joint prosthesis, each test socket has a substantially semispherically shaped member of different radius.
  • the surgical apparatus may be reused and the characteristics of the materials used in its manufacture must enable its sterilisation.
  • the tools must be made of materials suitable for sterilising in the autoclave and capable of withstanding said sterilisation cycles for as long as possible, while guaranteeing that their dimensional characteristics and shape remain unchanged.
  • each tool or template, or test socket being made of stainless steel or aluminium and being manufactured with automatic milling machines. After said machining, aluminium templates also undergo an anodic oxidation treatment.
  • each template or test socket also comprises through openings, called windows.
  • test head this is also manufactured using milling machines and made of plastic materials extruded in bars.
  • the test head comprises a substantially spherical body complete with a hole suitable for containing a shaft or the part of the final prosthesis that is implanted in the limb.
  • the implantation of a prosthesis involves the surgeon fashioning a recess in the area of the patient's bone where the prosthesis is to be implanted.
  • the surgeon fashions said recess in several subsequent stages, alternately removing a portion of bone and then checking the shape and size of the recess being prepared.
  • the bone is progressively removed using cutters, also called acetabular reamers, made entirely of steel, while the recess is checked and inspected with the aid of the above-mentioned templates. More in particular, the surgeon checks on the shape of the recess being fashioned using the test socket, which has the same shape and size as the part of the final prosthesis to implant, and consequently as the ideal recess that the surgeon needs to fashion in order to obtain the best possible anchorage of the implanted prosthesis. In fact, it is important to bear in mind that for the success and durability of the prosthetic implant procedure it is of the utmost importance to ensure the greatest possible stability of the prosthesis once it has been implanted in the patient's bone.
  • Said stability depends essentially on the shape of the recess and particularly on the accuracy with which the surgeon succeeds in fashioning said recess.
  • the recess In fact, to achieve the best possible stability it is essential for the recess to be shaped so that it matches the final socket or template for the prosthesis being implanted.
  • the surgeon uses the openings in the dome of the previously-mentioned template or test socket. More particularly, through said openings the surgeon checks for any discrepancies and decides on the action to take.
  • this test is done by inserting the template in the recess and attempting to ascertain, through the openings, whether the outer surface of the test socket adheres to the wall of the recess that has been fashioned or whether any further cutting is needed.
  • the surgeon again places the test socket in position inside the recess, without locking it in place, and then places first the adapter, then the test head inside the socket, inserting the final prosthesis or the rasp, or the test neck inside the hole. Finally, by taking action on the shaft, the physician moves the head in its seat, simulating/verifying the stability and mobility that the final implant will have once the procedure has been completed.
  • each socket comprises first connection means suitable for coupling with second connection means forming part of the adapter.
  • a first drawback of the apparatus used during surgical procedures for the placement of the above-described prosthetic implants of the known type, and particularly of the templates and tools (cutters, etc.) of the known type consists in that they are liable to wear and tear, and they have a limited life span, partly because of the sterilising operations that they must undergo before they can be used, and partly because of their usage. In fact, because of the frequent sterilising cycles and repeated usage, some parts of the test sockets or templates of the known type tend to deteriorate to the point of having to be replaced.
  • Another drawback lies in that the known type of apparatus comprises a considerable number of templates of various sizes available for the surgeon to choose from during the procedure, all these templates having to be sterilised again, every time, before they can be reused. Another drawback lies in that specific and costly equipment is needed to sterilise this apparatus, with a consequent fallout on the hospitals' overheads. In addition, in order to complete these operations, the apparatus must be placed in specific and costly containers suitable for placing in the autoclave. Another drawback lies in that, even if the apparatus, and particularly the test sockets, test heads and tools, are sterilised by the operators before and after each procedure, this may not be done adequately, with consequent well-known risks of infection for the patient.
  • Another drawback lies in that the previously-mentioned openings prevent the surgeon from homogeneously compacting the bone tissue forming the surface of the recess being fashioned, which is useful before inserting the final prosthesis, and this can induce an error in the surgeon's assessment of the situation.
  • Another drawback lies in the higher cost of the various parts of the apparatus. These costs relate substantially to the types of material used to manufacture the apparatus and the related production process, which necessarily involves the use of costly machine tools for the high-precision milling process.
  • a first object of the present invention is to produce a template, a tool and an apparatus for use during surgical procedures for fashioning prosthetic implants that can be manufactured without using milling machines, or at least reducing the number of milling operations.
  • Another object is to produce a tool and an apparatus that enable the surgeon to check the results of the cutting action performed on the bone more easily and effectively, and to assess the efficiency of the implant being fashioned.
  • Another object is to produce a template, a tool and an apparatus that are less expensive than those of the known state of the art and ready for use. The above objects are achieved by a template for use during the surgical procedures for fashioning prosthetic implants in accordance with the contents of the main claim.
  • FIG. 1 shows an exploded side view of the prosthesis shown in Figure 1;
  • FIG. 3 shows an exploded perspective view of the apparatus of the invention
  • FIG. 4 shows one of the parts of the apparatus shown in Figure 3, packaged in a sterile container;
  • FIG. 5 shows an axonometric view of a variant of the template of the invention
  • FIG. 6 schematically shows a perspective view of a step in the surgical procedure
  • FIG. 7 shows a partial cross-section side view of a subsequent step in the surgical procedure
  • FIGS. 8 and 9 each show a front view of a template placed in a recess fashioned in the patient's bone during successive assessment steps performed by the surgeon during a procedure for implanting a hip joint prosthesis of the type shown in Figure 1 ;
  • FIG. 10 and 11 each show a partial cross-section view of some of the steps in a procedure for implanting a hip joint prosthesis of the type shown in Figure i;
  • - Figure 12 shows a perspective view of another example of a template for an implantable knee joint prosthesis fashioned according to the invention;
  • FIG. 13 and 14 respectively show a front view and a side view of the template shown in Figure 12;
  • FIG. 15 and 16 each show a perspective view of another example of a template according to the invention.
  • FIG. 17 shows a view from above of a tool according to the invention.
  • FIG. 18 shows a cross-section view along the plane A-A of the tool shown in Figure 17, with an enlarged detail;
  • FIG. 19 shows a perspective view of an example of another tool according to the invention.
  • FIG. 20 shows a perspective view of an example of another tool according to the invention.
  • FIG. 21 shows a perspective view of an example of another tool or instrument according to the invention.
  • the corresponding parts of the single examples of embodiments are identified by means of the same numerical references.
  • the position indicators mentioned in the single embodiments can be logically transferred to the new position. While certain particular embodiments of the present invention are discussed in the description that follows, with reference to the attached figures, this is on the understanding that the present invention shall not be limited to said particular embodiments. Instead, the particular embodiments described below are used to clarify different aspects of the present invention, the object and scope of which are defined by the claims.
  • FIG. 1 a first embodiment illustrating several templates, tools and apparatus for use in surgical procedures for fashioning prosthetic implants, and preferably joint implants, according to the present invention.
  • a description is provided of the apparatus, tools and templates used, for instance, to fashion a prosthetic hip joint implant of the type shown in detail in Figures 1 and 2.
  • the hip prosthesis shown comprises a final socket C that is fixed to the hip bone O, an adapter D for a head T and a part P that is implanted in the limb bone S.
  • the solution proposed in the present invention is also applicable to all the tools, templates and apparatus that may be used in surgical procedures, and particularly to implant a prosthesis, preferably a joint prosthesis, as described in greater detail below.
  • Figure 3 shows a non-limiting example of some of the parts of an apparatus for use during surgical procedures for fashioning a prosthetic hip joint implant, indicated as a whole by the numeral 500.
  • a template 1 also called a test socket, which is also the subject of the invention, and an adapter 2 for engaging with the template 1 and for containing a test head 3 for a prosthesis and/or for a rasp.
  • the template 1 comprises a main member, or dome 4, substantially in the shape of a portion of a sphere.
  • the main member 4 has the shape of the recess that the surgeon needs to fashion in the patient's bone in order to insert a part of the prosthetic implant, consisting in this case of the socket C.
  • the main member can therefore clearly be of a different shape, depending on the shape of the part of the implant that the surgeon needs to insert.
  • the main member 4 is made of a non-metallic material, and preferably of a plastic or synthetic material.
  • the plastic material is of the type suitable for use in the medical setting, i.e. it does not induce irritation or other problems in the tissues with which it is intended to come into contact. It is also preferably lipid-resistant and suitable for sterilising with the aid of irradiation or gas.
  • the main member 4 may be made of any equivalent material. According to a preferred embodiment of the invention, the material also meets the requirements established by current standards, such as the FDA, ISO 10993-1 and USP Class VI.
  • the main member 4 is manufactured by means of a moulding process, and particularly by injection moulding.
  • the template 1 advantageously enables a marked reduction in the production costs of the template 1 and also enables, again according to the invention, the template 1 to be of the so-called disposable type, i.e. for use only once. It has been demonstrated, in fact, that moulding technologies enable the manufacture of templates with the required, repeatable dimensional characteristics and tolerances, within the manufacturing times typical of moulding processes and consequently at a considerably lower cost than the templates of the known type. It has also been demonstrated that the production cost of the proposed template is at least comparable to, and generally lower than the cost of sterilising the tools and apparatus of the known type.
  • the tool or template of the invention can advantageously be sterilised and packaged in a sterile container.
  • the template 1 is manufactured using the above-described moulding technology and is subsequently first sterilised and then packaged in a controlled atmosphere in a wrapping that guarantees its sterility.
  • the template 1 thus appears as shown schematically in Figure 4, sealed inside a sterile wrapping or container, ready for opening by the surgeon at the time of its use, consisting for instance of a sachet made of a synthetic material.
  • the other parts of the apparatus 500 i.e. the adapter 2 and the test head 3 in the example shown, comprise members and component parts made using the same materials.
  • the adapter 2 comprises a shaped member with second connection means 7 suitable for engaging with first connection means 6 forming part of the template 1.
  • Said means 6, 7 enable the adapter 2 to be stably juxtaposed with the test template 1 , and to become locked in several places around the circumference of the latter. This enables the internal diameter of the template to be adjusted, adapting it to the diameter of the test head 3 that the surgeon intends to use.
  • the test head 3 comprises a substantially spherical head element 8.
  • the adapter 2 and the test head 3 are also preferably manufactured using injection moulding processes and are preferably packaged in sterile containers. This enables the same advantages to be obtained for said parts 2 and 3 of the apparatus 500 as those described for the template 1.
  • Another embodiment of the template of the invention is distinguishable from the previous template in that the main member 41 has at least one opening 42. Said openings 42 afford the surgeon a direct view of at least a part of the recess prepared in the patient's bone when the template is inserted in the bone.
  • Another embodiment of the invention is distinguishable from the previous one in that the body of the template is made of a transparent plastic material.
  • the template is made of a transparent material and, more particularly, the main member is made, at least in part, of a plastic material comprising a polycarbonate.
  • this plastic material may consist, for instance, of ABS, PC, PMMA, PA, POM, PPSU, PE, PP, etc.
  • this advantageously facilitates several assessment steps that the surgeon completes during the procedure. More particularly, the transparent nature of the template affords the surgeon an advantageous direct visual control of the recess being fashioned in the patient's bone. More in detail, this enables the surgeon to verify the characteristics of the recess obtained more easily and immediately, and to better appreciate whether any corrective action is needed.
  • a plastic material such as polycarbonate (PC)
  • PC polycarbonate
  • it features a good dimensional stability and it is suitable for sterilising, using irradiation and/or gas for instance, as well as assuring good compatibility with organic tissues.
  • inventions may involve only one or several parts of the main member being transparent, and particularly those of greatest interest to the surgeon.
  • the transparent nature of the material used and the presence of fluid inside the recess afford the surgeon a better view of the operating field because the plastic material also has a sort of lens effect.
  • the disposable template or socket advantageously enables the surgeon to identify precisely any areas of non-contact, exploiting the whole surface of the piece because it is totally transparent.
  • This solution also enables the templates to be manufactured without the openings previously described, while retaining their disposable nature and enabling a visual control by the surgeon.
  • Another advantage lies in that, being without any openings, said template enables the surgeon to achieve an optimal compacting of the bone tissue, simultaneously giving the surgeon the opportunity to visually inspect the recess prepared.
  • the template clearly enables a better and more homogeneous compacting action on the bone tissue than is achievable with the known type of template because, as explained in greater detail below, this is done by pressing the template against the patient's bone after inserting it in the recess.
  • Figures from 12 to 16 show several other examples of embodiments of templates according to the invention. More particularly, Figures 12, 13 and 14 each show views of another example of a template for prosthetic knee joint implants, also called a positioner, indicated as a whole by the numeral 300, made according to the invention. Figures 15 and 16 each show views of another example of a template for prosthetic knee joint implants, also called a cutting mask, indicated as a whole by the numeral 400, and made according to the invention.
  • This template has through openings, indicated by the numeral 405, used to guide cutting tools consisting for instance of saws, used by the surgeon to resect the patient's bone.
  • the template 400 comprises a main member 401 that is made of plastic and inserts 402, coinciding with the openings 405, that are made of a material more resistant to mechanical wear.
  • these inserts 402 are preferably made of metal and are comoulded during the manufacture of the main member 401.
  • the use of a transparent plastic material to manufacture the main member 401 affords the surgeon a view of the operating field.
  • the tools used during the procedure can also be made as described above.
  • all or at least some of the parts of the apparatus used for the surgical procedure are of disposable type and comprise members and component parts made using the same materials, preferably including ABS, PC, PMMA, PA, POM, PPSU, PE, PP, etc.
  • These tools can therefore also advantageously be manufactured using injection moulding processes and preferably packaged in sterile containers. This enables the same advantages to be obtained for these tools as those described for the template 1.
  • Figures 17 and 18 show an example of embodiment of a tool according to the invention, indicated as a whole by the numeral 600, showing in particular a socket cutter comprising a substantially semispherical body 601 made of a plastic material with a set of inserts 602 preferably made of a metallic material, better illustrated in the enlarged detail in Figure 18, which identify the cutting edge.
  • the metal inserts 602 have been comoulded during the manufacture of the semispherical body.
  • the use of a transparent plastic material enables, for instance, the use of a micro TV camera or fibre-optics located in the vicinity of the rotary tool and, more precisely, of the body, to enable a view of the bone being treated.
  • Figure 19 shows a view from above of another example of a tool according to the invention, indicated as a whole by the numeral 700, and more in particular of a tool for a hip joint prosthesis, that is used to take action on the test templates during the surgical procedure.
  • Figure 20 shows a view from above of an example of another tool according to the invention, indicated as a whole by the numeral 800, and more in particular of a retractor preferably for use during surgical procedures for implanting hip joint prostheses.
  • the body of the tool is made of a plastic material and, if necessary, it can also contain inserts made of metal or other materials in the area where particular characteristics, e.g. of a mechanical nature, are required.
  • Figure 21 shows a perspective view of an example of another tool according to the invention, indicated as a whole by the numeral 900, and more in particular of a retractor preferably for use during surgical procedures for implanting knee joint prostheses.
  • the body of the tool and its gearing 901 are made completely or partially of a plastic material.
  • the tool can also include inserts made of metal or any other material in the areas where particular characteristics, e.g. of a mechanical nature, are required.
  • the surgeon after choosing a prosthesis of suitable size for the morphological characteristics of the patient, selects the corresponding template from among those available, without removing it from its sterile packaging. The surgeon then proceeds to prepare the recess in several successive stages, alternating bone removal operations with operations to check the shape and size of the recess being fashioned.
  • the bone removal operations are achieved with the aid of cutters, as illustrated schematically in Figure 6, such as those of the type previously described and illustrated in Figure 17, while the operations to test and control the recess are completed with the aid of the above-described templates. More particularly, the surgeon checks the shape of the recess being fashioned by removing the chosen template or test socket from its sterile packaging and placing it in the prepared recess.
  • a template of the type shown in Figure 5 the surgeon checks the recess by means of the openings 42 in the dome of the template 100; on the other hand, if a template of the type shown in Figure 3 is being used, which is made of a transparent material, the surgeon exploits the transparent nature of the member 4. It is worth noting at this point, moreover, that the surgeon using a transparent template can more easily check and identify any areas of contact or non-contact between the surface of the template and the surface of the recess, thanks to the fluids present inside the recess.
  • the surgeon evaluates the stability and functionality of the joint obtainable with the final implant. To do so, he/she places the template or test socket in the recess again, without fixing it in place, and then inserts first the adapter 2, which is anchored to the template 1 by the connection means 6, 7, and then the test head 3, inserting the prosthesis, the rasp or the test neck in the hole in the head, as illustrated for instance in Figures 10 and 11. Clearly, here again, the surgeon must first remove the adapter and the test head from their sterile packaging.
  • the proposed solution enables the previously mentioned drawbacks to be overcome.
  • the proposed solution advantageously enables a template, a tool and, more in general, parts of the apparatus used during surgical procedures to be made partially and/or entirely of a disposable and preferably transparent plastic material. This enables the surgeon to check more easily and immediately, for instance, the characteristics of the recess being fashioned and to better appreciate any corrective measures required.
  • the proposed solution also advantageously enables the manufacture of disposable templates, tools and apparatus that do not need to be sterilised in the autoclave and that enable a reduction in the space occupied by the instruments needed in the operating room. Moreover, preoperative studies enable the sizes of the templates that are expected to be best suited to the patient to be identified with the aid of x-rays etc., which means that the surgeon can bring to the operating room only the two or three templates in the sizes considered suitable, thus saving space.
  • the proposed solution also advantageously enables templates, tools and, more in general, parts of apparatus, or complete sets of apparatus, for use during surgical procedures to be made with considerably lower manufacturing costs than those of the known type of apparatus. This enables disposable templates, tools and, more in general, parts of apparatus, or complete sets of apparatus, to be made that are sterilised directly during the manufacturing process and packaged in suitable containers that guarantee their sterility.

Landscapes

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

Abstract

La présente invention concerne un gabarit (1, 100, 300, 400) devant être utilisé dans des actes chirurgicaux, de préférence lors d'actes de façonnage de prothèses articulaires, comprenant un élément principal (4, 401) ayant sensiblement la même forme qu'une partie de la prothèse à implanter, ledit gabarit étant du type jetable et comprenant un élément principal (4, 401) fait d'un matériau non métallique. L'invention concerne également un outil et un appareil devant être utilisés dans des actes chirurgicaux, de préférence lors d'actes de façonnage de prothèses articulaires.
PCT/IB2007/002770 2006-09-21 2007-09-14 gabarit, outil et appareil pour le façonnage d'implants prothétiques Ceased WO2008035198A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITVI2006A000280 2006-09-21
ITVI20060280 ITVI20060280A1 (it) 2006-09-21 2006-09-21 Dima, utensile ed attrezzatura per la realizzazione di impianti di protesi

Publications (2)

Publication Number Publication Date
WO2008035198A2 true WO2008035198A2 (fr) 2008-03-27
WO2008035198A3 WO2008035198A3 (fr) 2008-06-05

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IT (1) ITVI20060280A1 (fr)
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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2208469A1 (fr) * 2008-12-29 2010-07-21 DePuy Products, Inc. Bloc de découpe orthopédique
WO2011070367A3 (fr) * 2009-12-11 2011-09-01 Gursharan Singh Chana Appareil chirurgical
WO2013052584A1 (fr) * 2011-10-04 2013-04-11 Nho Shane Dispositif et procédé d'arthroscopie de la hanche
US8628560B2 (en) 2007-03-08 2014-01-14 DePuy Synthes Products, LLC Orthopaedic instrumentation with integral load-bearing members
US9987023B2 (en) 2008-12-29 2018-06-05 Depuy Ireland Unlimited Company Orthopaedic cutting tool having a chemically etched metal insert and method of manufacturing
EP3629891A1 (fr) * 2017-05-31 2020-04-08 Medichanical Engineering APS Équipement de mesure destiné à être utilisé en chirurgie de prothèse de la hanche

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4517969A (en) * 1983-03-03 1985-05-21 Zimmer, Inc. Prosthetic gauge
US4987904A (en) * 1990-03-22 1991-01-29 Wilson James T Method and apparatus for bone size gauging
US5472415A (en) * 1994-04-26 1995-12-05 Zimmer, Inc. Disposable provisional instrument component for evaluating the fit of an orthopaedic implant
GB0420346D0 (en) * 2004-09-13 2004-10-13 Finsbury Dev Ltd Tool

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8628560B2 (en) 2007-03-08 2014-01-14 DePuy Synthes Products, LLC Orthopaedic instrumentation with integral load-bearing members
AU2008201070B2 (en) * 2007-03-08 2014-01-23 Depuy Products, Inc Orthopaedic instrumentation with integral load-bearing members
US9987023B2 (en) 2008-12-29 2018-06-05 Depuy Ireland Unlimited Company Orthopaedic cutting tool having a chemically etched metal insert and method of manufacturing
CN101791240A (zh) * 2008-12-29 2010-08-04 德普伊产品公司 具有化学蚀刻金属插件的整形外科切割台及制造方法
EP2208469A1 (fr) * 2008-12-29 2010-07-21 DePuy Products, Inc. Bloc de découpe orthopédique
US9375221B2 (en) 2008-12-29 2016-06-28 Depuy (Ireland) Orthopaedic cutting block having a chemically etched metal insert
US9883876B2 (en) 2008-12-29 2018-02-06 Depuy Ireland Unlimited Company Orthopaedic cutting block having a chemically etched metal insert and method of manufacturing
WO2011070367A3 (fr) * 2009-12-11 2011-09-01 Gursharan Singh Chana Appareil chirurgical
WO2013052584A1 (fr) * 2011-10-04 2013-04-11 Nho Shane Dispositif et procédé d'arthroscopie de la hanche
EP3629891A1 (fr) * 2017-05-31 2020-04-08 Medichanical Engineering APS Équipement de mesure destiné à être utilisé en chirurgie de prothèse de la hanche
US11439518B2 (en) 2017-05-31 2022-09-13 Medichanical Engineering Aps Measuring equipment for use in connection with hip prosthesis surgery
US12290452B2 (en) 2017-05-31 2025-05-06 Medichanical Engineering Aps Measuring equipment for use in connection with hip prosthesis surgery
EP3629891B1 (fr) * 2017-05-31 2025-09-17 Medichanical Engineering APS Adaptateur de mesure pour un équipement de mesure destiné à être utilisé en chirurgie de prothèse de la hanche

Also Published As

Publication number Publication date
ITVI20060280A1 (it) 2008-03-22
WO2008035198A3 (fr) 2008-06-05

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