WO2008035198A2

WO2008035198A2 - Template, tool and apparatus for fashioning prosthetic implants.

Info

Publication number: WO2008035198A2
Application number: PCT/IB2007/002770
Authority: WO
Inventors: Giandomenico Gonella; Marco Peretto
Original assignee: Comeg Tecnologie S.R.L
Priority date: 2006-09-21
Filing date: 2007-09-14
Publication date: 2008-03-27
Also published as: ITVI20060280A1; WO2008035198A3

Abstract

The invention concerns a template (1) for use in surgical procedures, preferably for use during procedures for fashioning joint prostheses, comprising a main member (4) substantially in the same shape as a part of the prosthesis to implant, said template being of the disposable type and comprising a main member (4) made of a non-metallic material. The invention also concerns a tool (600) and an apparatus for use in surgical procedures, preferably for use during procedures for fashioning joint prostheses, the too being of the disposable type and comprising a part made of a non-metallic material.

Description

TEMPLATE, TOOL AND APPARATUS FOR FASHIONING PROSTHETIC IMPLANTS.

The present invention relates to orthopaedic surgery.

In particular, the invention concerns the apparatus used in orthopaedic surgery, particularly for operations involving the use of prosthetic implants.

More in detail, 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. It is common knowledge that 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.

These tools are used, as explained below, during the various stages of the procedure and, in the case of a kit for a hip joint prosthesis, they 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.

More precisely, to enable the reuse of the apparatus, and of the above-mentioned tools in particular, 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.

The known state of the art involves 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.

To meet the demand for a light weight and enable the surgeon to inspect the walls and the shape of the recess, as explained in more detail below, each template or test socket also comprises through openings, called windows.

As for the 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.

According to the known surgical technique, as mentioned previously, 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.

More in particular, 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.

As mentioned previously, 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.

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.

To check whether this is the case, 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.

More in detail, 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.

Surgeons repeat these steps several times until they achieve a recess that they consider adequate for containing the socket portion of the final prosthesis. Finally, before inserting and fixing the final socket to the bone, the surgeon assesses the stability and functionality of the joint obtainable with the final implant.

To do so, 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.

It should be noted, moreover, that each socket comprises first connection means suitable for coupling with second connection means forming part of the adapter. Once the required stability has been achieved, the surgeon implants the final prosthesis, inserting the final socket and then fixing it in place inside the previously-created recess.

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.

Another drawback lies in that the apparatus takes up a considerable amount of space and, after it has been sterilised, it must be stored in a suitable place. In the light of the above-described situation, it would be desirable to have a template, a tool and an apparatus for use during surgical procedures for fashioning prosthetic implants, and preferably for use in joint implants, that would enable the drawbacks of the known state of the art to be overcome, or at least reduced.

It would consequently be desirable to have a template, a tool and an apparatus for use during surgical procedures for fashioning prosthetic implants that would enable the drawbacks encountered in the templates, tools and apparatus used to fashion prosthetic implants as described above to be overcome. In particular, 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.

The above objects are also achieved by a tool for use during the surgical procedures for fashioning prosthetic implants in accordance with the contents of the corresponding independent claim.

The above objects are also achieved by an apparatus for use during the surgical procedures for fashioning prosthetic implants in accordance with the contents of the corresponding independent claim. Innovative and advantageous embodiments of the invention form the object of the corresponding dependent claims.

The above-mentioned objects and advantages are explained in greater detail in the description of several preferred embodiments of the invention, provided here as non-limiting examples with reference to the attached drawings, wherein: - Figure 1 schematically shows a cross-section view of a hip prosthesis implanted in a patient;

- Figure 2 shows an exploded side view of the prosthesis shown in Figure 1;

- Figure 3 shows an exploded perspective view of the apparatus of the invention; - Figure 4 shows one of the parts of the apparatus shown in Figure 3, packaged in a sterile container;

- Figure 5 shows an axonometric view of a variant of the template of the invention;

- Figure 6 schematically shows a perspective view of a step in the surgical procedure;

- Figure 7 shows a partial cross-section side view of a subsequent step in the surgical procedure;

- Figures 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 ;

- Figures 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;

- Figures 13 and 14 respectively show a front view and a side view of the template shown in Figure 12;

- Figures 15 and 16 each show a perspective view of another example of a template according to the invention;

- Figure 17 shows a view from above of a tool according to the invention;

- Figure 18 shows a cross-section view along the plane A-A of the tool shown in Figure 17, with an enlarged detail;

- Figure 19 shows a perspective view of an example of another tool according to the invention;

- Figure 20 shows a perspective view of an example of another tool according to the invention;

- Figure 21 shows a perspective view of an example of another tool or instrument according to the invention. First of all, it should be noted that the corresponding parts of the single examples of embodiments are identified by means of the same numerical references. In the event of a change of position, 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. With reference to the attached figures, the following is a description of 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. In particular, 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. Clearly, 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.

This comprises 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. In the preferred embodiment illustrated, the template 1 comprises a main member, or dome 4, substantially in the shape of a portion of a sphere.

More in general, 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.

According to the invention, the main member 4 is made of a non-metallic material, and preferably of a plastic or synthetic material.

More particularly, 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. Clearly, however, 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.

Again according to a preferred embodiment of the invention, the main member 4 is manufactured by means of a moulding process, and particularly by injection moulding.

This 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.

It should be noted, moreover, that the tool or template of the invention can advantageously be sterilised and packaged in a sterile container.

In fact, again according to a preferred embodiment of the invention, 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.

This advantageously overcomes the need for the template sterilising process normally required before the template can be used. Similarly, 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.

More particularly, 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, indicated as a whole by the numeral 100 in Figure 5, 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. More particularly, according to said embodiment of the invention, 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. In other embodiments, this plastic material may consist, for instance, of ABS, PC, PMMA, PA, POM, PPSU, PE, PP, etc.

As explained in greater detail later on, 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. It should be noted, moreover, that a plastic material such as polycarbonate (PC), once it has been extracted from the mould used to manufacture the template, is advantageously already sufficiently transparent and does not need any further particular treatments. Moreover, 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. Other embodiments may involve only one or several parts of the main member being transparent, and particularly those of greatest interest to the surgeon. On this point, it should be noted that 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. In fact, 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. In fact, having no openings for inspection purposes, 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.

Thus, the good resistance of the material used and the absence of any openings combine to make it suitable for compacting the surface of the bone before inserting the final socket.

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. It should be noted, moreover, that in this embodiment 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. In the example shown, these inserts 402 are preferably made of metal and are comoulded during the manufacture of the main member 401. Again according to the invention, the use of a transparent plastic material to manufacture the main member 401 affords the surgeon a view of the operating field. Similarly to the situation described above and in accordance with the invention, the tools used during the procedure can also be made as described above.

More particularly, 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. In the example shown, 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. Here again, 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. Here again, the body of the tool and its gearing 901 are made completely or partially of a plastic material. If necessary, 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. In practice, when using the proposed apparatus 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.

More precisely, if a template of the type shown in Figure 5 is being used, 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. In fact, when the recess has not been fashioned adequately, these fluids give rise to areas of a different colour in the body of the template, as shown in detail in Figure 8, which identify the areas of non-contact between the surface of the template and the surface of the recess. Vice versa, when the surface of the recess juxtaposes with that of the template, the latter reveals a substantially uniform "staining", as shown schematically in Figure 9. This phenomenon helps the surgeon in the necessary testing operations, on the basis of which he/she decides what further action to take. The surgeon repeats these steps several times until the recess that has been fashioned is considered suitable for containing the socket of the final prosthesis. Finally, before inserting and fixing the final socket C to the patient's bone, 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.

Taking action on the prosthesis or rasp or test neck, the physician moves the head inside its seat, thus simulating/verifying the stability and mobility that the final implant will assure when the procedure has been completed, as shown in Figure 1. Having obtained the required stability, the surgeon proceeds to implant the final prosthesis, inserting and then fixing the final socket in the recess that has been fashioned, as shown in Figure 1.

Based on the above description, it is clear that the proposed solution enables the previously mentioned drawbacks to be overcome. In particular, 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.

This avoids the need for the hospital to conduct the sterilising procedures needed with the sockets, tools and apparatus of the known type, and the consequent need to provide the related sterilising equipment. Although the invention has been described with reference to the attached drawings, it may be modified in the executive stage while still coming within the same inventive concept expressed by the following claims and consequently protected by the present patent.

Clearly, moreover, where the characteristics mentioned in the following claims are followed by reference signs, these are used simply to improve the readability of the claim concerned and not as any kind of limitation on the interpretation of said claim.

Without departing from the scope of the invention, a person skilled in the art may make improvements to the template and the surgical apparatus for fashioning prosthetic implants as prompted by natural technological progress.

It must be emphasised, moreover, that all the components may be replaced by other, technically equivalent parts, and that the materials used, providing they are compatible with the intended usage, as well as the sizes of the various components, may vary according to need.

Claims

1) A template (1, 100, 300, 400) for use in surgical procedures, preferably for use during procedures for fashioning joint prostheses, comprising a main member (4, 401) substantially in the same shape as a part of the prosthesis to implant, characterised in that said main member (4, 401) is made of a non-metallic material.

2) A template (1, 100, 300, 400) for use in surgical procedures, preferably for use during procedures for fashioning joint prostheses, characterised in that said template (1, 100, 300, 400) is of the disposable type. 3) A template according to claim 2), characterised in that it comprises a main member in a shape substantially corresponding to a part of the prosthesis to implant, said main member (4, 401) comprising at least one part made of a non-metallic material.

4) A template according to claim 1) or 3), characterised in that said non- metallic material is a plastic material.

5) A template according to claim 4), characterised in that said material consists of ABS and/or PC, and/or PMMA, and/or PA, and/or POM, and/or PPSU, and/or PE, and/or PP.

6) A template according to claim 1) or 4) or 5), characterised in that it is manufactured using a process that comprises at least one injection moulding operation.

7) A template according to any of the previous claims, characterised in that it has inserts made of a different, preferably metallic material.

8) A template according to claims 6) and 7), characterised in that said inserts are comoulded with said main body.

9) A template according to any of the previous claims, characterised in that it comprises at least one transparent part.

10) A template according to any of the previous claims, characterised in that it includes at least one inspection opening. 11) A template according to any of the previous claims, characterised in that it is contained inside a sterile container. 12) A tool (600, 700, 800, 900) for use during procedures for fashioning prosthetic implants, preferably for joint prostheses, characterised in that it is of the disposable type. 13) A tool according to claim 12), characterised in that it comprises at least one part made of a non-metallic material.

14) A tool according to claim 13), characterised in that said non-metallic material is a plastic material.

15) A tool according to claim 14), characterised in that said material consists 5 of ABS, PC and/or PMMA, and/or PA, and/or POM, and/or PPSU, and/or

PE, and/or PP.

16) A tool according to claim 13) or 14), characterised in that it is _^ manufactured using a process that comprises at least one injection moulding operation. o 17) A tool according to any of the claims from 12 to 16), characterised in that it includes inserts made of different, preferably metallic materials.

18) A tool according to claims 16) and 17), characterised in that said inserts are comoulded with the main body of said tool.

19) A tool according to any of the claims from 12) to 18), characterised in5 that it is contained inside a sterile container.

20) A tool according to any of the claims from 12) to 19), characterised in that it includes at least one transparent part.

21) An apparatus (500) for use during surgical procedures for fashioning prosthetic implants, and preferably joint prostheses, comprising at least one template, characterised in that said template is made according to any of the claims from 1) to 11).

22) An apparatus for use during surgical procedures for fashioning prosthetic implants, and preferably joint prostheses, comprising at least one tool (600, 700, 800, 900), characterised in that said tool is made according to any of5 the claims from 12) to 20).

23) An apparatus according to claim 22), characterised in that it also comprises a template, said template being made according to any of the claims from 1) to l l).

24) An apparatus according to claim 22), characterised in that it also comprises a template or test socket (1, 100, 300, 400) and/or a cutter (600), and/or a cutting mask (700), and/or a positioner (700, 800), and/or a retractor (900).

25) An apparatus according to claim 21) or 22) or 23) or 24), characterised in that all the parts of said apparatus are contained in one or more sterile containers.