Kits for the installation of prosthetic components and / or biomedical implants

Abstract

The prosthetic part and the taproot are advantageously made of a biocompatible metallic material, i.e. titanium or an alloy thereof, the taproot having at least one portion with a triangular cross section when viewed in horizontal section. The kit of the invention further comprises at least one first guide part for a guidewire for guiding the insertion of the guidewire (K) into the bone and at least one second guide part for an impactor having a triangular cross section.

Description

[Technical field]

[0001] The present invention relates to a kit for installation of prosthetic components and / or bioimplants, including a prosthetic component having an intraosseous taproot formed integrally with the prosthesis, for attaching the prosthetic component to a patient's bone.

[0002] Intraosseous biomedical devices for attaching prosthetic components, also known in the art as taproots, are made of biocompatible metallic materials such as titanium and / or its alloys and are suitable for use in attaching bioimplants, i.e., prosthetic components or portions such as, but not limited to, orthopedic prostheses, to bone.

[0003] By way of example, and not limitation, the prosthetic component and / or bioimplant installation kit of the present invention can be used for installation of acetabular prosthetic implants, as well as implantation of prosthetic knees, elbows, shoulders, pelvises, etc. [Background technology]

[0004] Many known biomedical applications use taproots that are inserted into the bone to firmly anchor the prosthetic component to the bone itself.

[0005] Examples of such applications are found in acetabular prostheses (Figure 1) and knee prostheses (Figure 2). In all currently known applications, the main root has a circular cross section, and this shape allows the surgeon to adapt components such as the ligament, acetabulum, or tibial tray of a prosthetic knee joint intraoperatively, even when the prosthesis has already been inserted into the bone, by rotating them around the longitudinal axis of the main root.

[0006] Examples of taproots with shapes other than circular cross-section include nails used for bone fusion, such as fixation of the sacroiliac joint, and the Thornton or three-flange locking nail used in the 1970s to treat femoral neck fractures.

[0007] An example of a taproot with a triangular geometric shape is given in US Pat. No. 9,339,394 B2, illustrating an artificial vertebral facet suitable for replacing the cartilage and bone parts of the natural vertebral articular facet. Among alternative embodiments of the fixation system, a transpedicular screw with a triangular cross section is shown. The taproot of the above-mentioned patent is therefore not rigidly joined to the prosthetic element, so that the patent does not address the issue of ensuring the proper orientation of the prosthetic element in space corresponding to the orientation of the taproot, nor does it describe or suggest the use of a guide piece for the proper positioning of the prosthetic element.

[0008] There are currently no examples of systems or kits using taproots with cross sections other than cylindrical for the reconstruction / replacement of bone parts in intraosseous fixation systems, because the circular cross section fits almost any anatomical structure, allowing serial production in different sizes and the surgeon being responsible for the optimized positioning of the taproot in the patient's bone and therefore the orientation of the prosthetic elements in relation to the taproot.

[0009] Nevertheless, these known arrangements still suffer from certain drawbacks.

[0010] These disadvantages include primarily the inability of the conventional circular cross-section taproot to withstand the torsional loads imposed on the prosthesis, whereas a stem with a cylindrical cross-section faces a low resistance to torsional strain, provided only by friction between the stem and the inner surface of the bone with which it contacts.

[0011] Furthermore, the circular cross-section taproot of the prior art places the responsibility on the surgeon, who has no reference and must use fluoroscopy, which effectively exposes the surgeon and the patient to x-rays.

[0012] SUMMARY OF THE DISCLOSURE Accordingly, the present patent application aims to overcome the remaining shortcomings of the prior art, as will be more clearly explained below. Summary of the Invention

[0013] The main object of the present invention is to provide a kit for the installation of prosthetic components and / or biological implants, said prosthetic components including a main root for intraosseous fixation of the prosthetic components in the reconstruction and / or replacement of bone parts, which overcomes or at least reduces the disadvantages of the prior art systems.

[0014] To this end, it is an object of the present invention to provide a prosthetic component that includes a taproot for intraosseous fixation of the prosthetic component, capable of torsional loading.

[0015] A further object of the present invention is to provide a prosthetic part comprising a main root for intraosseous fixation of the prosthetic part, which allows a unique positioning of the main root and the associated prosthetic part relative to the anatomical site of the patient with which it is associated, thereby guiding the surgeon in the positioning of the main root and thus the prosthetic part, dramatically reducing the risk of incorrect positioning and optimizing the surgery, thereby allowing bone reconstruction even in highly complex situations.

[0016] The above as well as these and other objects of the present invention are achieved by a kit for the installation of a prosthetic component and / or a biological system, said prosthetic component comprising a main root for intraosseous fixation of the prosthetic component in the reconstruction and / or replacement of a bone part, thereby obtaining good stability and good load-bearing capacity of the implant even a short time after the reconstruction.

[0017] The above mentioned objects as well as these and other objects of the present invention are achieved by a kit for the installation of a prosthetic part comprising a main root for intraosseous fixation according to claim 1.

[0018] Further features of the kit and the prosthesis part comprising a taproot for intraosseous fixation according to the invention form the subject matter of the dependent claims. [Brief description of the drawings]

[0019] The characteristics and advantages of the prosthetic part comprising a main root and / or a kit for the installation of a biological implant made of a biocompatible metallic material for intraosseous fixation of a prosthetic part according to the invention, as well as of the prosthetic part comprising said main root according to the invention, will become more readily apparent on reading the following detailed description, given by way of example and not of limitation, with reference to the accompanying schematic drawings in which: [Figure 1] FIG. 1 shows an example of a circular cross-section taproot of the prior art. [Diagram 2] FIG. 2 shows an example of a circular cross-section taproot of the prior art. [Diagram 3] FIG. 3 shows a front view of a taproot equipped with a prosthetic component of the invention. [Figure 4] FIG. 4 shows a front view of the taproot of FIG. 3, showing only the central body without the trabecular portion. [Diagram 5] FIG. 5 is a vertical cross-sectional view taken along the vertical plane AA shown in FIG. [Figure 6] FIG. 6 is a top view of the taproot of FIG. [Figure 7] FIG. 7 shows a perspective view of a main root of the invention with an acetabular prosthetic component. [Figure 8] FIG. 8 shows a perspective view of a main root of the invention with an acetabular prosthetic component. [Figure 9] Figure 9A shows a front view of an example of a first guidewire guide element according to an embodiment suitable for installation of an acetabular prosthetic component, Figure 9B shows a perspective view of the guidewire guide element of Figure 9B, and Figure 9C shows a step of computed tomography imaging of the surgical area to define the design of the guidewire guide element. [Figure 10] FIG. 10 illustrates the guidewire guide element of FIGS. 9A and 9B of the present invention properly positioned and oriented with a guidewire inserted and in relation to the acetabulum seat of the pelvis. [Figure 11]Figure 11A shows a front view of an example of a second guide element for a triangular impactor. Figure 11B shows a perspective view of the triangular impactor guide element of Figure 9B. Figure 11C shows the step of computed tomography imaging of the surgical area to define the design of the triangular impactor guide element. [Figure 12] FIG. 12 illustrates the triangular impactor guide element of FIGS. 11A and 11B of the present invention properly installed and oriented in relation to the acetabulum seat of the pelvis. [Figure 13] FIG. 13 shows the main root of the present invention in relation to an acetabular prosthesis inserted into a patient's pelvis, with optional fixation screws added. [Figure 14] FIG. 14 shows the main root of the present invention in relation to an acetabular prosthesis inserted into a patient's pelvis, with optional fixation screws added. [Figure 15] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Figure 16] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Figure 17] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Figure 18] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Figure 19]1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Figure 20] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Figure 21] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Figure 22] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Diagram 23] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Figure 24] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Diagram 25] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. [Figure 26] 1A-1D show steps for preparing a surgical site for reconstruction of the left femoroacetabular joint using a fixation kit of the present invention, which includes a guide part for preparing the implantation site and a prosthetic element having a pair of triangular cross-section main roots according to the present invention. Detailed Description of the Invention

[0020] The present invention relates to a kit 100 for installing a prosthetic acetabular component 40, 50, said prosthetic component 40, 50 comprising one or more main roots 10 depending on the extent of the osteotomy, for intraosseous fixation of the prosthetic component itself in the reconstruction and / or replacement of the bone portion.

[0021] The prosthetic parts 40,50 which are part of the kit 100 of the invention comprise a main root 10 for intraosseous fixation formed integrally with said prosthetic parts 40,50.

[0022] The prosthetic components 40, 50 and the main root 10 are monolithic structures made of a biocompatible metallic material, more particularly a metallic material based on titanium and / or titanium alloys.

[0023] Advantageously, the main root 10 comprising the prosthetic parts 40, 50 of the kit 100 of the invention is manufactured using 3D EBM (Electron Beam Melting) additive manufacturing technology and has a structure including a solid central body 11 with a triangular cross section when viewed in a substantially horizontal plane and trabecular portions 12 firmly joined to said central body 11, as shown for example in FIG. 3.

[0024] Advantageously, the main root 10 of the present invention has at least one portion having a substantially triangular cross section when cut along a horizontal plane. As shown in the top view of Figure 6 and the perspective views of Figures 7 and 8, according to a preferred embodiment of the present invention, the entire length of the main root 10 of said prosthetic parts 40, 50, including the end sections 11a, 11b, has a triangular cross section.

[0025] Advantageously, the main root 10 of the prosthesis part 40, 50 of the invention further comprises, inside the central body 11, a longitudinal through hole 15 for receiving a guide wire during implantation.

[0026] Advantageously, the main root 10 may further comprise one or more additional drainage holes 16 in communication with said axial hole 15 for connecting said axial hole 15 with the outside in order to create an exit path for bone cement, platelet concentrate or stem cells injected through the central hole 15 once the central hole 15 is used as a guide for a guide wire in order to stabilize the system in cases where the surgeon is not satisfied or confident of the purely mechanical holding strength of the main root, e.g. due to the consistency of bone tissue.

[0027] Said drain hole 16 may advantageously have an inner diameter of 2.5 mm and an outer diameter of 4.5 mm.

[0028] With further reference to the accompanying drawings, the taproot 10 of the present invention includes at its anterior end 11a an end element 13 having a frustoconical profile along a vertical plane, preferably having a height a of about 5 mm, as shown in Figures 3 to 5. The frustoconical anterior end element 13 is configured to facilitate insertion of the taproot into the medullary canal of the patient's bone.

[0029] Meanwhile, the rear end 11b of the main root 10, designed for connection to a prosthetic element associated with a bone, may be provided with a base element 14 having a width D along a vertical longitudinal plane and a height b, preferably of about 2 mm.

[0030] According to a preferred embodiment of the present invention, the taproot 10 is formed integrally with the prosthetic components 40, 50, advantageously using EBM techniques.

[0031] Advantageously, as shown in the accompanying drawings, said front end 11a of said taproot has a frusto-conical shape 13 having a proximal larger base 13a and a distal smaller base 13b.

[0032] The frusto-conical end element 13 is rigidly joined to the central solid core 11 or is formed integrally therewith, advantageously by EBM, and has a width at its larger base 13a equal to the overall width D of the taproot.

[0033] Advantageously, the width D of the larger base 13a, also considered in a vertical plane as in the front views of Figures 3 and 4, is greater than the width d of the cylindrical central core 11, the difference c=Dd being shown in Figure 4 and preferably greater than 1 mm, so that the prismatic portions 12 formed integrally with said central cylinder 11 by EBM do not exceed the width D of said larger base 13a.

[0034] Thus, the trabecular portion 12 extends around said central body 11 having a triangular cross section while remaining within the shape defined by the two end elements 13, 14 of the taproot, as shown, for example, in FIG.

[0035] This placement reduces the likelihood of damage or rupture of the trabecular segment due to intraosseous insertion.

[0036] FIG. 6, showing a top view of the taproot 10 of the present invention, illustrates the triangular cross-sectional configuration of the frusto-conical end elements 13.

[0037] The axial length of the taproot 10 of the present invention may vary depending on the anatomical site and / or particular needs of the patient, and advantageously ranges from 20mm to 100mm.

[0038] The configuration of the main root 10 of the present invention described above includes a solid central body 11 and trabecular portions 12, which may be inserted into the bone by a press or interference fit during surgery, providing load-bearing properties as well as bone healing over time and stimulation of the bone by the trabecular portions.

[0039] One study conducted on titanium scaffolds manufactured by the applicant (Int. J. Mol. Skiing. 2021, 22, 2379; “Superior Osteo-Inductive and Osteo-Conductive Properties of Trabecular Titanium vs. PEEK Scaffolds on Human Mesenchymal Stem Cells: A Proof of Concept for the Use of Fusion Cages”) confirmed the superior osteoinductive and osteoconductive properties of the Ti6Al4V ELI trabecular titanium structure.

[0040] As mentioned above, the prosthetic components 40, 50 including the taproot 10 of the present invention are advantageously formed by a manufacturing technique involving localized melting of (metallic or polymeric) powders using a high energy electron beam.

[0041] These techniques, known as EBM (electron beam melting), are cutting-edge manufacturing techniques capable of forming objects of highly complex shapes and varying surface roughness from a computer design of the finished product, processed by computerized machines that direct the action of electron beams.

[0042] Electron beam melting is a relatively new rapid prototyping technique for producing implant structures, offering complex three-dimensional shapes.

[0043] Using this technology, applicants have developed a kit 100 of the present invention in which the prosthetic components 40, 50 include a taproot 10 having a portion with a trabecular structure 12 with an intertrabecular pore size on the order of 100 microns.

[0044] More specifically, preferably the ordered columnar structure 12 has a pore size in the range of 400-800 microns, more preferably the pore size is about 600 microns, preferably 640 microns.

[0045] That is, the titanium or titanium alloy trabecular structure 12 has an elastic modulus that closely matches that of natural trabecular bone, restoring physiological load transfer, thereby preventing bone damage and even promoting bone regrowth.

[0046] It should be noted that the EBM technique allows the trabecular portions 12 to be formed integrally with the central body 11 .

[0047] The Applicant has also found that the particular configuration of the main root 10 of the present invention, i.e. comprising a central body 11 having a solid structure connected at its ends to end portions 13, 14 as described, and large trabecular portions 12 extending around said central body 11, ensures that the implant has optimal mechanical load-bearing behavior in vivo, due to both the structure of the main root 10 and its triangular cross-section which provides excellent resistance to torsional loads, thereby immediately achieving primary stability of the plant.

[0048] The outermost trabecular portion 12 also ensures osseointegration of the system in the first few weeks after surgery and further improves the primary stability and "grip", i.e., friction to resist movement after the initial postoperative stage, especially pull-out of the taproot.

[0049] The taproot 10 of the present invention, as described above, includes an axial through hole 15, which allows for guidewire-guided implantation of the device and, if desired, allows the surgeon to inject a volume of biocement into the taproot to further enhance the stability of a simple press-fit.

[0050] The triangular cross-section also provides important biomechanical advantages compared to known taproot types, such as the ability to withstand torsional loads and allowing a unique positioning, facilitating the surgeon to properly position the implant relative to the bone with appropriate instruments, thus reducing the importance of manual orientation, which in known systems is defined by the surgeon during surgery, resulting in the problems mentioned above.

[0051] This particular advantage is achieved by the kit 100 consisting of the main root 10 of the invention and additional guide elements forming an instrument for guiding the surgeon during the implantation of the prosthesis.

[0052] The aforementioned kit 100 is also encompassed by the present invention and comprises, in addition to the main root 10, a first guidewire guide part 20 for guiding the insertion of a guidewire and a second guide part 30 for an impactor having a triangular cross section.

[0053] In particular, with reference to Figures 9A, 9B and 10, a first guidewire guide part 20 is shown, and with reference to Figures 11A, 11B and 12, a second guide part 30 for a triangular impactor adapted to form a seat of the main root 10 in the bone. As shown in the figures, the first guidewire guide part 20 advantageously includes a seat 20a for receiving the guidewire k and a peripheral marker 20b, while the second triangular impactor guide part 30 includes a first seat 30a for receiving a guidewire already placed in the bone and in the impactor, and a peripheral marker 30b. These references, which guide the surgeon in the orientation of the parts, ensure proper positioning of the guide elements and therefore proper orientation of the main root seat formed in the bone to receive the triangular main root 10.

[0054] Each of said first and second guide parts 20, 30 is advantageously designed according to the surgical procedure to be performed.

[0055] Thus, for example, Figures 18-20 show different embodiments of the first guidewire guide component 20 that are specifically configured for procedures involving osteotomies of the pelvic bones using an anatomical template 60, as shown in Figures 15-17, where such osteotomies may cover a large portion of the bone, as in the unfortunate case of bone cancer.

[0056] The first guidewire guide part 20 is configured to perfectly match the shape of the bone edge on which it is designed to rest.

[0057] FIG. 21 shows a different embodiment of the second guide part 30 for the impactor, specially designed for this procedure, with a triangular cross section, so as to perfectly match the shape of the bone edge on which it is designed to rest.

[0058] In order to produce custom-made parts that can be perfectly adapted to the bone surface with which they are to come into contact, thereby ensuring a unique and therefore safe positioning, said guide parts 20, 30 are advantageously manufactured by a technique known as EBM, which provides for the local melting of (metal or polymer) powders by means of a high-energy electron beam.

[0059] Thus, the first and second guide parts 20, 30 can advantageously be custom-made to suit the patient and the type of procedure to be performed based on a CT scan to image the anatomical site where the prosthesis will be implanted and planning of the procedure, with the guide elements also being custom-made accordingly to guide the proper positioning of the prosthesis.

[0060] Figures 22 to 26 show by way of example a prosthesis 50 associated with the main root 10 of the invention, specifically designed for the reconstruction of the femoro-acetabular joint, necessary to restore the function of a joint that had to be completely removed for selected types of procedures.

[0061] In the following, an embodiment of custom-made manufacturing of the guide parts 20, 30 is described, which makes it possible to design and carry out even very complex bone and / or joint reconstruction procedures, as shown in the accompanying drawings, but it should be understood that the main root 10 and the guide parts 20, 30 can also be mass-produced, advantageously in different sizes, which has the advantage of ensuring excellent attachment of the prosthesis to the bone by the main root.

[0062] The kit including the taproot 10 and the custom-made guide parts 20, 30 in particular offers further advantages compared to mass-produced parts, which are highly valued and / or allow procedures that are not feasible with standard mass-produced parts.

[0063] As mentioned above, these advantages can be summarized as follows: Very high geometric accuracy, ensuring the highest precision of the contact surface between the prosthesis and the bone; that there is no need to change or adapt the positioning of the components (carpal and guide components) during the procedure, allowing the surgeon to be sure of proper prosthesis positioning even under very difficult procedural conditions; Excellent biointegrative and osteoinductive properties due to the trabecular structure of the taproot, and high mechanical resistance to torsional loads due to the solid central part and triangular cross-section; Radiolucency and low infection risk rate.

[0064] To manufacture the custom parts, the captured images are processed with 3D image processing software to generate the design of the custom guide parts 20, 30.

[0065] Thus, the process for custom manufacturing of the guidewire guide component 20 and the impactor guide component 30 advantageously includes the following steps: capturing a CT scan image of the patient; processing the CT images followed by segmentation to create a 3D model of the patient's bone tissue; A process of designing custom-made guide components 20, 30.

[0066] The manufacturing method of the guide parts 20, 30 described above focuses on restoring the anatomical structure and functionality of the anatomical site to be treated and also allows for proper attachment of the main root 10 and its associated prosthetic elements to the bone tissue, thereby ensuring long-term stability of the prosthesis.

[0067] The design of the particular instruments, i.e. guide components 20, 30, can guide the surgeon to reproduce as closely as possible in the operating room the in situ positioning of the biomedical device defined during the pre-operative planning phase.

[0068] Such a device including the guide parts 20, 30 and the main root 10 can be designed, as described above, in a patient-specific manner with mating surfaces that perfectly fit the host anatomical site, thereby providing the surgeon with a fixed and unique positioning function, preventing any risk of mispositioning and facilitating the procedure since the surgeon does not need to change or adapt the positioning of the parts during the operation.

[0069] A method of using the guide components 20, 30 according to the present invention includes at least the following steps: using said first guide piece 20 to allow the insertion of a guidewire K in a direction set during the design of the surgical procedure; Next, while holding the guide wire K in place, a second guide piece 30 is positioned which acts as a guide for the proper orientation of the impactor having a triangular cross section, thereby forming a seat for the taproot 10.

[0070] The successive use of the two guide parts 20, 30 of the invention makes it possible to uniquely define the direction and orientation of the primary root 10 and therefore of the prosthetic part 50 which is rigidly joined thereto.

[0071] Finally, the main root 10 is implanted in a guided manner due to the presence of an axial through hole 15 allowing the insertion of a guide wire K, which is then inserted by means of an impactor guided by said second guide part 30, by means of a clamping press fit into the seat formed in the bone.

[0072] As mentioned above, the kit 100 including the main root 10 constituted by the two guide parts 20, 30 allows to reproduce during surgery what was defined in the pre-operative design phase, thus guiding the surgeon in the implantation of the main root and its associated prosthetic parts.

[0073] In the case of custom-made prostheses and components, all components of the kit are designed based on the patient's anatomy, and in particular on the morphology of the particular implantation area.

[0074] The positioning of the two custom-made guide parts 20, 30 and thus the taproot 10 is unique, as the contact surfaces of the guide parts to the bone surface are unique and perfectly complementary.

[0075] The features and advantages of the taproot 10 of the present invention and the kit 100 including such taproot will be apparent from the above description.

[0076] It has been particularly shown that the kit 100 of the present invention, in particular the guide elements 20, 30 which can be mass-produced or custom-made in different sizes according to the patient's specific anatomical morphology, can guide the surgeon in the placement of the triangular main root 10 and thus the associated prosthetic components, dramatically reducing or eliminating the risk of mispositioning.

[0077] Thus, a dedicated instrument comprising said guide elements 20, 30 allows the use of a triangular primary root 10 as described above, which, as already mentioned, brings about considerable advantages, such as a higher resistance to torsional loads and a higher accuracy in positioning the prosthesis in perfect agreement with that established during the preoperative planning.

[0078] It will be understood that the intraosseous triangular taproot thus conceived is susceptible to modification and / or variations, all of which are encompassed by the present invention, the scope of which is defined by the appended claims.

[0079] In particular, the materials and dimensions described can be varied as required.

Claims

**Claim 1** A kit (100) for the installation of a prosthesis component (40, 50) and / or a bioprosthesis, said kit (100) comprising a prosthesis component (40, 50), and further comprising an intramedullary main root (10) made integrally for fixing said prosthesis component (40, 50) to the bone of a patient, said prosthesis component (40, 50) and said main root (10) being made of a biocompatible metallic material, in particular titanium or an alloy thereof, said main root (10) of said prosthesis component (40, 50) comprising a solid central body (11) comprising an axially through hole (15), and, outside said central body (11), a small columnar portion (12) firmly joined to said central body (11) or made integrally with said central body (11), said kit having at least one section having a triangular cross-section when viewed in a substantially horizontal cross-section, said kit (100) further comprising at least one first guide component (20) for a guide wire (K) for guiding the insertion of the guide wire into the bone and at least one second guide component (30) for an impactor having a triangular cross-section, a kit (100) for the installation of a prosthesis and / or a bioprosthesis. **Claim 2** The kit (100) for the installation of a prosthesis and / or a bioprosthesis according to claim 1, characterized in that each of said guide components (20, 30) is made in a patient-specific manner by processing an image from a computed tomography scan of the anatomical structure of the patient. **Claim 3** The kit (100) for the installation of a prosthesis and / or a bioprosthesis according to claim 1, characterized in that each of said guide components (20, 30) is designed to fit uniquely into the anatomical site of the prosthesis implantation, thereby ensuring proper positioning of the guide element and thus of said guide wire and said triangular cross-section impactor, thereby ensuring proper orientation of said triangular sheet inside the bone and thus proper positioning of said triangular main root (10). **Claim 4** The kit (100) for the installation of a prosthesis and / or a bioprosthesis according to claim 1, characterized in that said prosthesis component (40, 50) and said main root (10) are made integrally. **Claim 5** The prosthesis part (40, 50) and the main root (10) are integrally made by 3D lamination technology, i.e., EBM technology, for the kit (100) for installing the prosthesis and / or the bioprosthesis according to claim 1.

6. The prosthesis element (40, 50) includes an intramedullary main root (10) having a triangular cross-section over its entire length when viewed in a substantially horizontal plane, for the kit (100) for installing the prosthesis and / or the bioprosthesis according to claim 1.

7. The prosthesis element (40, 50) includes an intramedullary main root (10), and the central body (11) of the intramedullary main root (10) also has a triangular cross-section over at least a part or the entire length when viewed in a substantially horizontal plane, for the kit (100) for installing the prosthesis and / or the bioprosthesis according to claim 1.

8. The intramedullary main root (10) of the prosthesis element (40, 50) includes end sections (11a, 11b), and the end sections (11a, 11b) also have a triangular cross-section when viewed in a substantially horizontal plane, for the kit (100) for installing the prosthesis and / or the bioprosthesis according to claim 1.

9. The prosthesis element (40, 50) includes an intramedullary main root (10), and the intramedullary main root (10) includes an end element (13) having a frustum of a cone profile when viewed in a vertical plane at its front end (11a), for the kit (100) for installing the prosthesis and / or the bioprosthesis according to claim 1.

10. The prosthesis element (40, 50) includes an intramedullary main root (10), and the end element (13) of the intramedullary main root (10) has a width (D) equal to the overall footprint of the main root (10) in the same plane in a vertical longitudinal plane, for the kit (100) for installing the prosthesis and / or the bioprosthesis according to claim 1.

11. The intramedullary main root element (10) includes a base element (14) having a width (D) equal to the overall footprint of the main root (10) in the same plane in a vertical longitudinal plane at the rear end (11b) of the main root (10) designed to connect to a prosthesis element associated with bone, characterized in that the prosthesis and / or the kit (100) for installing a bioprosthesis according to claim 1.

12. The prosthesis element (40, 50) includes the intramedullary main root (10) according to one or more of the preceding claims, and the intramedullary main root (10) is integrally formed with the prosthesis element (50), characterized in that the prosthesis and / or the kit (100) for installing a bioprosthesis according to claim 1.

13. The columnar portion (12) of the intramedullary main root (10) extends around the central body (11) having a triangular cross-section, but remains within the shape defined by the end elements (13, 14) of the main root, characterized in that the prosthesis and / or the kit (100) for installing a bioprosthesis according to claim 1.

14. The columnar portion (12) has a pore diameter in the range of 400 to 800 microns, preferably about 600 microns, more preferably 640 microns, characterized in that the prosthesis and / or the kit (100) for installing a bioprosthesis according to claim 1.

15. The columnar portion (12) of the intramedullary main root (10) is integrally formed with the central body (11) by EBM, characterized in that the prosthesis and / or the kit (100) for installing a bioprosthesis according to any one of claims 1 to 14.

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