Prosthesis for fractured long bones

Abstract

The invention relates to a prosthesis (P) for a fractured long bone, comprising a stem portion (1) and an implant (20) distinct from the stem portion (1), the stem portion (1) comprising: a rod (3) configured to be inserted into a bone marrow cavity (8) of a diaphyseal fragment (2) of the fractured long bone to secure the stem portion (1) to the diaphyseal fragment (2); and an epiphyseal (5) fixedly secured to the rod (3) by at least one connecting leg (7) of the stem part (1) such that a gap (9) is formed between the epiphyseal and the rod (3) along the at least one connecting leg (7), the implant (20) comprising: an inner portion (22) located at least partially within the gap (9), and at least one fastener (24) for fastening epiphyseal fragments (4) of the fractured long bone to the stem portion (1), the at least one fastener (24) being fixed to the inner portion.

Description

[0001] This application is a divisional application of the invention application with application number 201910099418.5 and invention name “Prosthesis for fractured long bones”. Technical Field

[0002] The present invention relates to a prosthesis for a fractured long bone.

[0003] The present invention relates to the field of arthroplasty, preferably to shoulder arthroplasty or hip arthroplasty. The present invention is preferably applicable to human patients, but may also be applied to animal patients. Background Art

[0004] US2004 / 0230311A1 discloses a shoulder prosthesis for replacing the upper humerus in certain fracture types. This known prosthesis includes a stem to be inserted into the humeral canal, a middle portion reduced to a medial column, and a head as a hollow and roughly spherical cap. The head of the prosthesis is coated with an osteoconductive material, and the sides of the medial column and the upper portion of the stem are also coated with the same material. These components define an epiphyseal-metaphyseal space in which a solid autologous bone graft is assembled. Engagement can be achieved between the coated portion of the prosthesis, the bone graft reattached to the humeral shaft and fixed to the hole of the medial column, and the tuberosity and between themselves. This known type of prosthesis means that the tuberosity is sutured to the hole of the medial column so that the tuberosity is reattached thereto.

[0005] However, sutures are sometimes unable to prevent postoperative migration of the tubercle due to patient movement, particularly because muscles are often anchored to the tubercle. Furthermore, attaching the tubercle by suturing requires a high degree of dexterity on the part of the surgeon.

[0006] The object of the present invention is to overcome the above-mentioned drawbacks of the prior art. Summary of the invention

[0007] In particular, the object of the present invention is to provide a new prosthesis for fractured long bones which makes the surgical procedure easier and prevents postoperative migration of the tuberosity, thus enabling optimization of the patient's healing process following the surgery.

[0008] The present invention is defined below:

[0009] A prosthesis for a fractured long bone, the prosthesis comprising:

[0010] - a stem portion comprising:

[0011] o a rod configured to be inserted into the medullary cavity of a diaphyseal fragment of a fractured long bone to secure the stem portion to the diaphyseal fragment, and

[0012] o an epiphyseal end fixedly secured to the rod by at least one connecting leg of the stem portion, thereby forming a gap between the epiphyseal end and the rod along the at least one connecting leg; and

[0013] - An implant distinct from a stem portion, the implant comprising:

[0014] o an interior portion located at least partially within the gap, and

[0015] o At least one fastener for fastening the epiphyseal fragments of a fractured long bone to the stem portion, the at least one fastener being secured to the inner portion.

[0016] The invention allows the epiphyseal fragments to be fixed to the prosthesis by at least one fastener in addition to or as an alternative to sutures. Thus, a more convenient, stable and lasting fixation of the epiphyseal fragments is achieved. Since the inner part of the implant is a different part to be positioned in the gap relative to the stem, the surgeon can choose on the spot whether the prosthesis should be provided with this inner part according to the situation: the stem can be used without the implant.

[0017] Further optional and advantageous features of the invention are defined below:

[0018] - The at least one fastener comprises a screw positioned in the inner part.

[0019] The inner part has resilient tongues which enable the inner part to snap-fit ​​into the gap in order to secure the inner part in the gap.

[0020] -The inner part includes at least one expandable body, which has: a contraction structure that enables the expandable body to be inserted into the gap; and an expansion structure that prevents the expandable body from being pulled out of the gap, thereby fixing the expandable body in the gap, and the expandable body is placed in the expansion structure by fixing a fastener to the expandable body.

[0021] The implant comprises at least one outer portion located at least partially at the periphery of the stem portion along at least one connecting leg, the outer portion being fixed to the inner portion.

[0022] - the stem portion defines a main axis passing through the rod, the gap and the epiphyseal end; and the at least one outer portion includes an axial through-opening, through which the stem portion is inserted along the main axis so as to be at least partially enclosed by the outer portion, thereby fixing the outer portion to the stem portion.

[0023] - The inner part comprises a synthetic plastic material.

[0024] - The synthetic plastic material of the inner part comprises polyethylene or polyetheretherketone.

[0025] - The inner part comprises a mesh-like metal material or a porous metal material.

[0026] - The metal material of the inner part comprises titanium and / or nitinol.

[0027] - At least a portion of the implant comprises a peripheral shell and at least one bone graft core received within the at least one peripheral shell.

[0028] - At least a part of the implant comprising the peripheral shell and the at least one bone graft core is an inner part.

[0029] - The peripheral shell comprises biological material.

[0030] - The peripheral shell comprises a degradable polymer or a degradable metal.

[0031] The outer shell comprises at least one of the following composite materials: a composite of hydroxyapatite and tricalcium phosphate, a composite of polylactide-co-glycolide and tricalcium phosphate, and a composite of poly-L-lactide and tricalcium phosphate.

[0032] - The implant body comprises barbs projecting outwardly from the implant body outside the gap.

[0033] - At least a part of the implant is obtained by additive manufacturing.

[0034] -The prosthesis is a shoulder prosthesis for a fractured humerus.

[0035] In US2004 / 0230311A1, although bone grafts can contribute to good healing of the tuberosity, the bone grafts need to be shaped to fit the epiphyseal-metaphyseal space. When a bone graft is obtained from another bone part of the patient (e.g., the humeral head), the surgeon must shape the graft in situ, which is time-consuming and requires high dexterity. In addition, due to the mechanical properties of the bone graft, it may be difficult to obtain the appropriate shape even with specific tools.

[0036] The object of the present invention is to overcome the above-mentioned drawbacks of the prior art.

[0037] In particular, it is an object of the present invention to provide a new prosthesis for fractured long bones which promotes bone ingrowth and which is easier to implement.

[0038] The present invention relates to a prosthesis for a fractured long bone, the prosthesis comprising:

[0039] - a stem portion comprising:

[0040] o a rod configured to be inserted into the medullary cavity of a diaphyseal fragment of a fractured long bone to secure the stem portion to the diaphyseal fragment, and

[0041] o an epiphyseal end fixedly secured to the rod by at least one connecting leg of the stem portion, thereby forming a gap between the epiphyseal end and the rod along the at least one connecting leg; and

[0042] - An implant distinct from the stem portion and positioned adjacent to the at least one connecting leg, the implant comprising a peripheral shell and at least one bone graft core received within the peripheral shell.

[0043] The present invention enables one or more bone graft cores to be positioned in a prefabricated peripheral shell having a more precise shape than the bone graft. Due to the peripheral shell, the implant can be better fixed to the stem portion, for example by assembling the implant in the gap, the shape of the shell corresponding to the shape of the gap. The peripheral shell is preferably made of biomaterial, thereby promoting bone ingrowth as effectively as the prior art that only provides bone grafts. Therefore, the advantages of precise shape are combined with the bone ingrowth ability. The shape of the peripheral shell can also be selected to improve the fixation of epiphyseal fragments on the prosthesis. For example, the shape can be selected to correspond to the shape of the epiphyseal fragments and / or to be used to clamp the fragments. Since the implant is a different part relative to the stem portion, the surgeon can choose on the spot whether the implant should be included in the prosthesis according to the situation. Therefore, the stem portion can be used without an implant.

[0044] Further optional and advantageous features of the invention are defined below:

[0045] - the outer shell comprises biological material;

[0046] - the outer shell comprises at least one of the following composite materials: a composite of hydroxyapatite and tricalcium phosphate, a composite of glycolide-lactide copolymer and tricalcium phosphate, a composite of poly-L-lactide and tricalcium phosphate;

[0047] - the outer shell comprises a degradable polymer or a degradable metal;

[0048] - the peripheral housing comprises a synthetic plastic material, preferably comprising polyethylene or polyetheretherketone;

[0049] - the outer shell comprises a meshed metal material or a porous metal material, preferably comprising titanium or nitinol;

[0050] -The peripheral shell is obtained by additive manufacturing;

[0051] - the implant body comprises a barb positioned to protrude outwardly from the implant body;

[0052] - the peripheral shell and the at least one bone graft core form an inner portion of the implant at least partially located within the gap;

[0053] - the implant comprises at least one fastener for fastening the epiphyseal fragment of the fractured long bone to the stem portion, the at least one fastener being fixed to the inner portion;

[0054] - the at least one fastener comprises a screw positioned into the inner portion;

[0055] - the inner part has a resilient tongue which enables the inner part to snap fit into the gap to secure the inner part in the gap;

[0056] - the peripheral shell and the at least one bone graft core form at least one outer portion of the implant, the outer portion being at least partially located at the periphery of the stem portion along the at least one connecting leg, the outer portion being fixed to the stem portion through the gap;

[0057] - providing at least two outer parts, said outer parts being fixed to each other such that the outer parts are mechanically fixed to the stem part;

[0058] - a primary outer part of the outer part comprises a primary fastener, and a secondary outer part of the outer part comprises a secondary fastener complementary to the primary fastener, the primary fastener being configured to cooperate with the secondary fastener to secure the primary outer part to the secondary outer part;

[0059] - the stem portion defines a main axis passing through the rod, the gap and the epiphyseal end, and the at least one outer portion comprises an axial through-opening, through which the stem portion is inserted along the main axis so as to be at least partially enclosed by the outer portion, thereby fixing the outer portion to the stem portion;

[0060] -The implant includes:

[0061] o an inner portion comprising a peripheral shell and at least one bone graft core, and

[0062] o At least one outer portion comprising a peripheral shell and at least one bone graft core, the outer portion being secured to the inner portion.

[0063] In the case of prostheses similar to the one disclosed in US 2004 / 0230311 A1, it may be difficult for the surgeon to secure certain shapes of epiphyseal fragments or very fragile or thin fragments to the prosthesis.

[0064] The object of the present invention is to overcome the above-mentioned drawbacks of the prior art.

[0065] In particular, the object of the present invention is to provide a new prosthesis for fractured long bones which helps to fix epiphyseal fragments thereto, or to replace non-viable epiphyseal fragments.

[0066] The present invention relates to a prosthesis for a fractured long bone, the prosthesis comprising:

[0067] - a stem portion comprising:

[0068] o a rod configured to be inserted into the medullary cavity of a diaphyseal fragment of a fractured long bone to secure the stem portion to the diaphyseal fragment, and

[0069] o an epiphyseal end fixedly secured to the rod by at least one connecting leg of the stem portion, thereby forming a gap between the epiphyseal end and the rod along the at least one connecting leg; and

[0070] An implant distinct from the stem portion, the implant comprising at least one outer portion located at least partially at the periphery of the stem portion along the at least one connecting leg, the outer portion being fixed to the stem portion through the gap.

[0071] In the present invention, the implant is different from the stem, so that the surgeon can choose on the spot whether the stem should be provided with an external part according to the situation. Therefore, the stem can be used without an implant. The external part is attached to the stem through a gap so that the external part can be easily and reliably fixed thereon. One or more epiphyseal fragments can be fixed to the external part. The external part can structurally reinforce the fragments fixed thereon. The fragments can be supported by the external part to which the fragments are attached. Therefore, even thin or fragile fragments can be reattached to the stem. In addition, one or more external parts can replace fragments in the fragments that will not be reintroduced into the patient's body. For a single stem, the presence of the external part makes it possible to obtain a patient-specific or at least desired peripheral shape of the prosthesis, so that the surgeon can modify the prosthesis and adapt it to any situation by providing an appropriate external part.

[0072] Further optional and advantageous features of the invention are defined below:

[0073] - providing at least two outer parts, said outer parts being fixed to each other such that the outer parts are mechanically fixed to the stem part;

[0074] - a primary outer part of the outer part comprises a primary fastener, and a secondary outer part of the outer part comprises a secondary fastener complementary to the primary fastener, the primary fastener being configured to cooperate with the secondary fastener to secure the primary outer part to the secondary outer part;

[0075] - the implant further comprises an inner portion located at least partially within the gap, and the at least one outer portion is fixed to the inner portion;

[0076] - the stem portion defines a main axis passing through the rod, the gap and the epiphyseal end;

[0077] - the at least one outer part comprises an axial through-opening, through which the stem part is inserted along the main axis so as to be at least partially enclosed by the outer part, thereby fixing the outer part to the stem part;

[0078] - the implant comprises at least one fastener for fastening the epiphyseal fragment of the fractured long bone to the stem portion;

[0079] - said at least one fastener is fixed to said at least one external portion;

[0080] - the at least one fastener is fixed to the inner part;

[0081] - the inner part has a resilient tongue which enables the inner part to snap fit into the gap to secure the inner part in the gap;

[0082] - at least one fastener for fixing said at least one outer part to the inner part comprises a screw positioned in the inner part;

[0083] - the inner portion includes at least one expandable body having: a contracted structure that enables the expandable body to be inserted into the gap; and an expanded structure that prevents the expandable body from being pulled out of the gap, thereby fixing the expandable body in the gap, and the expandable body is placed in the expanded structure by fixing a fastener to the expandable body;

[0084] - the implant body, in particular the aforementioned at least one outer part, comprises a synthetic plastic material, preferably polyethylene or polyetheretherketone;

[0085] - the implant, in particular at least one of the outer parts, comprises a mesh-like metallic material or a porous metallic material, preferably titanium and / or nitinol;

[0086] - the implant body, in particular at least one of the aforementioned external parts, comprises a biomaterial;

[0087] - the implant, in particular at least one of the aforementioned outer parts, comprises at least one of the following composite materials: a composite of hydroxyapatite and tricalcium phosphate, a composite of co-lactide-glycolide and tricalcium phosphate, a composite of poly-L-lactide and tricalcium phosphate;

[0088] - the implant body, in particular at least one of the outer parts, comprises a degradable polymer or a degradable metal;

[0089] - the at least one outer part comprises a peripheral shell and at least one bone graft core received in the peripheral shell,

[0090] - the inner portion comprises a peripheral shell and at least one bone graft core received within the peripheral shell;

[0091] - The implant comprises barbs positioned along the outer portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0092] Further advantages and advantageous features of the invention are disclosed in the following description, provided for illustrative and non-limiting purposes only, with reference to the accompanying drawings.

[0093] In the attached picture:

[0094] - Figure 1 is a schematic perspective view of a prosthesis according to one embodiment of the present invention;

[0095] - Figure 2 yes Figure 1 Exploded view of the prosthesis;

[0096] - Figure 3 is a schematic perspective view of an implant of a prosthesis according to another embodiment of the present invention;

[0097] - Figure 4 is a schematic perspective view of a prosthesis according to another embodiment of the present invention;

[0098] - Figure 5 is a schematic perspective view of a prosthesis according to another embodiment of the present invention;

[0099] - Figure 6 is a schematic exploded perspective view of a prosthesis according to another embodiment of the present invention;

[0100] - Figure 7 is a schematic exploded perspective view of a prosthesis according to another embodiment of the present invention;

[0101] - Figure 8 is a schematic exploded perspective view of a prosthesis according to another embodiment of the present invention;

[0102] - Fig. 9 is a schematic perspective view of a prosthesis according to another embodiment of the present invention;

[0103] - Fig.10 is a schematic perspective view of a prosthesis according to another embodiment of the present invention;

[0104] - Fig.11 and Fig.12 yes Fig.10Schematic stereograms of an implant of a prosthesis in two different orientations;

[0105] - Fig.13 is a schematic perspective view of a prosthesis according to another embodiment of the present invention;

[0106] - Fig.14 and Fig.15 yes Fig.13 Schematic stereograms of an implant of a prosthesis in two different orientations;

[0107] - Fig.16 is a schematic perspective view of an implant of a prosthesis according to another embodiment of the present invention;

[0108] - Fig.17 is a schematic perspective view of a prosthesis according to another embodiment of the present invention;

[0109] - Fig.18 and Fig.19 yes Fig.17 Schematic stereograms of an implant of a prosthesis in two different orientations;

[0110] - Fig. 20 is a schematic rear perspective view of a prosthesis according to another embodiment of the present invention;

[0111] - Fig.21 yes Fig. 20 A schematic front perspective view of a prosthesis;

[0112] - Fig. 22 and Fig.23 yes Fig. 20 and Fig.21 Schematic stereograms of an implant of a prosthesis in two different orientations;

[0113] - Fig.24 is a schematic perspective view of a prosthesis according to another embodiment of the present invention;

[0114] - Fig.25 and Fig.26 yes Fig.24 Schematic stereograms of an implant of a prosthesis in two different orientations;

[0115] - Fig. 27 and Fig.28 is a schematic perspective view of an implant of a prosthesis according to another embodiment of the present invention; and

[0116] - Fig.29 is a schematic cross-sectional view of a prosthesis according to another embodiment of the present invention. DETAILED DESCRIPTION

[0117] Figures 1 to 18 The prosthesis P is a prosthesis P for fractured long bones, in particular fractured humerus. Therefore, Figures 1 to 18 The Prosthesis P is designed for shoulder arthroplasty.

[0118] like Figure 1 As shown schematically by the dotted lines in the figure, the fractured long bones include:

[0119] a diaphyseal fragment 2 having a generally tubular shape, comprising a medullary cavity 8 which is interrupted at the proximal end 10 of the fragment 2, where the bone fracture has occurred, and

[0120] - Three epiphyseal fragments 4 or tubercles to be positioned at the ends 10 of the fragments 2 in order to reconstruct the original bone.

[0121] Depending on the fracture type, more or less than three fragments 4 may be formed from the initial tubercle of the patient's bone. The patient's muscles may initially anchor to all or some of the fragments 4.

[0122] The initial long bone may include a head for articulating with another bone, in this case the humeral head for articulating with the glenoid cavity of the patient's scapula. Figure 1 The prosthetic head 6 schematically shown in dashed lines is replaced. The prosthetic head 6 shown is a spherical head, but an inverted head or a concave head can be used instead. Alternatively, in other embodiments, all or part of the initial head can be retained.

[0123] In addition to fractured humeri and shoulders, the embodiments disclosed herein may also be applied to other fractured long bones and joints, such as fractured femurs and hips.

[0124] Figures 1 to 18 All prostheses P comprise the same stem part 1 .

[0125] The stem portion 1 of each embodiment includes a rod 3 configured to be inserted into the medullary cavity 8 of the fragment 2 to fix the stem portion 1 to the fragment 2. Preferably, the rod 3 fits into the cavity 8, for example, in a conical shape. Bone ingrowth promoting material, cementing material, fasteners, or a combination of known techniques may be used to fix the rod 3 to the fragment 2. The end of the rod 3 points to the distal end of the fragment 2 and is inserted through the proximal end 10 thereof.

[0126] The stem 1 of each prosthesis P according to the invention comprises an epiphyseal end 5. The epiphyseal end 5 is located opposite the rod 3 along the main axis X1 of the stem 1, the axis X1 being coaxial with the rod 3. The end 5 emerges from the fragment 2. The end 5 can carry the above-mentioned head 6, which is a prosthetic head or is made from a fragment of the patient's original head. The head 6 is located proximal to the end 5.

[0127] The stem portion 1 of each embodiment comprises three connecting legs 7 substantially parallel to the axis X1 or slightly inclined (angled) relative to this axis X1. Each leg 7 advantageously has a reduced cross-section compared to the rod 3 and the end 5. Each leg 7 connects the distal side of the end 5 to the proximal end of the rod 3. The legs 7 are preferably distributed around the axis X1. Thus, the proximal end of the rod 3 faces the distal side of the end 5 along the axis X1.

[0128] like Figures 1 to 18 As shown, for example, one connecting leg 7 may have a through hole 12 for securing a suture or other component.

[0129] The end 5 is fixedly fixed to the rod 3 by means of the connecting legs 7 of the stem portion 1. Thus, a gap 9 is formed between the epiphyseal end 5 and the rod 3 along the connecting legs 7. The axis X1 passes through the gap 9. In other words, the gap 9 is defined by:

[0130] - rod 3, in particular its proximal end,

[0131] - the epiphyseal end 5, in particular its distal side, and

[0132] - Connecting legs 7.

[0133] More or less than three legs 7 may be provided for the stem portion 1. At the minimum, only one leg 7 is provided.

[0134] The epiphyseal fragment 4 is fixed to the stem portion around the axis X1 , substantially at the level of the gap 9 height along the axis X1 . In other words, the fragment 4 is reattached along the leg 7 .

[0135] When two or more legs 7 are provided for the stem 1, at least one through opening is defined by two of these legs 7, the rod 3 and the end 5, so that the gap 9 can be accessed from the outside of the stem 1 through the through opening. Figures 1 to 18 In the example shown of a stem portion 1 provided with three legs 7, three through openings 11, 13 and 15 are defined. Figure 1 The opening 11 can be seen in Figure 2 Three openings 11, 13 and 15 can be seen in FIG. In the case where the prosthesis P is a shoulder prosthesis, the openings 11 and 13 are anteroposterior, while the opening 15 is lateral. More generally, these through openings are radial relative to the axis X1.

[0136] Preferably, the stem portion 1 is made of a material having specific mechanical properties suitable for withstanding at least the same mechanical stresses as the original bone and having the same structural function as the original bone. For example, the rod 3, the end 5 and the legs 7 may comprise a biocompatible metal material, a synthetic plastic material, a ceramic material or any other suitable material, or a combination of these materials. Preferably, the selected material is durable after being implanted in the body, in other words, is not bioresorbable.

[0137] If the prosthesis P is a shoulder prosthesis, it may also include a glenoid portion configured to form a prosthetic joint with the stem portion. In this case, the glenoid portion is connected to the epiphyseal end of the stem portion in an articulated manner.

[0138] Figures 1 to 18 Each prosthesis P also includes a corresponding implant, each implant being a structure separate from the stem portion 1. In other words, the stem portion and the implant are different and can be separated from each other. In each embodiment, the implant is positioned close to the connecting leg 7.

[0139] Focus on Figure 1 and Figure 2 , the prosthesis P comprises an implant 20. The implant 20 comprises an inner portion 22 which is preferably positioned completely within the gap 9, between the legs 7 and between the rod 3 and the end 5.

[0140] In a preferred embodiment, the inner portion 22 has the general shape of a parallelepiped, a brick or a prism with a trapezoidal base.

[0141] In some embodiments, for example, the inner portion 22 may partially extend out of the gap 9 through one or more of the openings 11, 13 and 15. However, in this case, the inner portion 22 is preferably mostly enclosed within the gap 9.

[0142] The inner part 22 can be made of one integral part, in other words a single piece, which is Figure 1 and Figure 2 Another embodiment disclosed below shows a situation where the internal part is composed of multiple parts.

[0143] Figure 1 and Figure 2 The inner portion 22 preferably comprises a material which is softer than the material of the stem portion 1 .

[0144] Inner portion 22 may include a material configured to be durable after being implanted within the body.

[0145] Alternatively, the material of the inner part 22 is degradable or bioresorbable, so that the inner part 22 is partially or completely resorbed after being implanted in the patient's body for a certain period of time. This can be achieved by degradable polymers, degradable metals or degradable biomaterials.

[0146] The inner part 22 may include a synthetic plastic material. "Synthetic plastic material" means that the material is composed of macromolecules obtained by polymerization, polycondensation or polyaddition, etc. Preferably, the inner part 22 is completely composed of such a synthetic plastic material. Preferably, the synthetic plastic material may include, but is not limited to, polyethylene (PE) or a copolymer thereof. Alternatively or additionally, the plastic material may include polyetheretherketone (PEEK) or a copolymer thereof.

[0147] For materials intended to be bioresorbable or degradable after implantation in a patient, degradable polymers may be used. Preferably, the inner portion 22 comprises one or two of the following degradable polymers: glycolide-lactide copolymer and poly-L-lactide. Additionally or alternatively, the degradable material may include polyanhydrides, polyurethanes, and polysaccharides.

[0148] Alternatively or additionally, the inner portion 22 comprises a biological material or a bioceramic, referred to herein as a "biomaterial". Preferably, the inner portion 22 is made entirely of such a biomaterial. The biomaterial may include one or both of the following materials: hydroxyapatite and tricalcium phosphate. A biomaterial comprising both hydroxyapatite and tricalcium phosphate is preferred.

[0149] Alternatively, the inner portion 22 comprises a composite material comprising a biomaterial and a degradable polymer. Preferably, the inner portion 22 comprises at least one of the following composite materials:

[0150] - a complex of a glycolide-lactide copolymer and tricalcium phosphate, and

[0151] - A complex of poly-L-lactide and tricalcium phosphate.

[0152] Alternatively or additionally, the inner part 22 comprises a metallic material. Preferably, the inner part 22 consists entirely of such a metallic material.

[0153] The metal material may be selected to be durable after being implanted in a patient. For example, the metal material may include titanium. Alternatively or additionally, the metal material may include nitinol. The metal material may be an alloy of one or more of the above metal materials.

[0154] Alternatively, a bioresorbable metal may be selected. Preferably, the inner portion 22 has a porous structure. Such a structure may promote bone ingrowth to improve healing. In particular, in the case of selecting a metal material, such a porous structure may also ensure the softness of the inner portion 22.

[0155] If chosen to be porous, the inner portion 22 preferably comprises a biomaterial and / or a degradable polymer as defined above. Alternatively, a metal mesh or grid structure may be chosen.

[0156] Alternatively, the inner portion 22 may have a solid structure, in other words, a complete structure without holes.

[0157] The inner part 22 may include a material that is a composite material of the above materials. The inner part 22 may be made entirely of the composite material.

[0158] The inner part 22 can be manufactured specifically for the patient, ie be patient-specific.The inner part 22 can be obtained by additive manufacturing, in particular in case a metal material is chosen.

[0159] Preferably, the shape of the inner part 22 corresponds to the shape of the gap 9 so that the inner part 22 can fit into the gap 9. Preferably, the inner part 22 is mounted into the gap 9 through the opening 15. Preferably, the inner part 22 is mounted by press fitting.

[0160] At least a portion of the implant 20 can be applied to the stem 1 to adapt the prosthesis P to different applications. This portion is preferably the inner portion 22. For example, by combining the stem with an implant 20 dedicated to the right shoulder or an implant 20 dedicated to the left shoulder, a left shoulder prosthesis and a right shoulder prosthesis with the same reference stem can be obtained. Therefore, fewer stem references are required.

[0161] Figure 1 and Figure 2 The implant 20 includes screws 24 implanted or positioned in an inner portion 22. Preferably, each screw 24 is screwed onto the inner portion 22. The inner portion 22 may optionally include a pre-drilled hole for positioning the screw 24 therein.

[0162] Each screw 24 projects from the inner portion 22 through one of the openings 11, 13 or 15 of the stem portion 1. Each screw 24 is oriented substantially radially to the axis X1. In the case of a shoulder prosthesis, the screws 24 may be oriented in the anterior, posterior or lateral direction.

[0163] The screws 24 are positioned to fix the epiphyseal fragments 4 to the stem 1. Each fragment 4 is preferably locked between the head of the associated screw 24 and the stem 1. Each screw 24 passes through a hole provided through one fragment 4. One or more screws 24 may be implemented to fix each fragment 4 respectively.

[0164] Therefore, the fragment 4 can be fixed to the stem part 1 by means of screws 24, making fixation easier and more reliable than in the prior art. Therefore, the risk of postoperative migration of the fragment 4 is greatly reduced. Depending on the material of the inner part 22, bone ingrowth and healing can still be promoted.

[0165] Each screw may have a differential pitch. In other words, the distal portion of the screw may have a thread of a first value, while the proximal portion of the screw may have a thread of a second value different from the first value. The differential pitch may provide compression or prestressing of the fragment 4 when fixed to the stem portion 1.

[0166] Depending on the application, other fasteners similar or equivalent to the above-described screws 24, such as nails, rivets, clips, or staples, may be used instead. In addition to screws, similar features also apply to these other fasteners.

[0167] Preferably, the fastener is at least partially rigid. In particular, the term "fastener" does not refer to the suture itself. The fastener may comprise a wire or a suture: when such a wire or a suture is foreseen, the fastener also comprises at least one rigid portion.

[0168] Although not shown in the figures, the inner part 22 may include integrally formed barbs. For example, the term "barb" may refer to a pin or a claw. Thus, the barbs may help to better fix the fragment 4 on the stem part 1. These barbs advantageously protrude from the gap 9 at the periphery of the stem part 1. The barbs preferably protrude outwardly from the inner part 22. The barbs preferably protrude in a direction radial to the axis X1 or protrude slightly obliquely relative to this direction.

[0169] exist Figure 3 In the embodiment of the present invention, the inner portion 32 may have the same Figure 1 and Figure 2 The embodiment of the present invention also has the same features as the inner part 22 described in the embodiment, and also includes one or more elastic tongues 34, elastic protrusions and / or recesses 36 or similar clamping devices. In this case, the implant of the prosthesis P includes the inner part 32 instead of the inner part 22. Therefore, the inner part 32 can be fixed to the stem part 1 by snap-fitting or clamping the stem part 1 in the gap. Advantageously, the inner part 32 can also be disengaged from the stem part 1. In order to achieve a snap-fit ​​or clamping of the inner part 32, the gap 9 is optionally provided with a protrusion or recess that interacts with the protrusion or recess of the inner part 32. Through this embodiment, the positioning of the implant is very easy and particularly reliable.

[0170] Now go to Figure 4, the implant 40 includes a fastener (preferably a screw 24) and an inner part 42, which can also have the same features as the inner part 22 and / or 32. The inner part 42 receives two fasteners 24 to fix the epiphyseal fragments 4. In this case, the implant 40 of the prosthesis P includes the inner part 42 instead of the inner part 22. In addition to the fasteners 24, the inner part 42 also receives one or more anchors 44. Each anchor 44 is implanted in the inner part 42, so that the anchor is preferably fixedly fixed to the inner part 42 relative to the inner part 42. Sutures 46 for fixing one or more fragments 4 can be attached to the anchors 44. Through this embodiment, the advantages of the sutures are combined with the advantages of the fasteners. Therefore, depending on the situation, the position of the anchor can be adjusted to improve the fixation performed with the sutures 46 without modifying the stem part 1.

[0171] exist Figure 5 In the embodiment, the implant 50 includes a screw 24 and an expandable body 52 constituting an inner portion.

[0172] In an embodiment not shown, the implant 50 may include more than one screw 24 and more than one different expandable body 52, the expandable body forming the inner part of the implant. Preferably, one expandable body is provided for each screw 24. Thus, for this embodiment not shown, the inner part may consist of a plurality of different expandable bodies, whereas in the other embodiments described above, the inner part preferably consists of only a single piece, preferably a single piece, or of a plurality of pieces fixedly attached together.

[0173] In the present case, the screw 24 is screwed onto the expandable body through the threaded hole of the expandable body. The expandable body has a radial contraction structure, which enables the expandable body to be inserted into the gap through an opening 11, 13 or 15. "Radial" refers to the direction that is radial relative to the axis of rotation of the screw 24. The expandable body also has a radial expansion structure, which prevents the expandable body from being pulled out of the gap 9. In fact, when the expandable body is as Figure 5When positioned in the gap 9 in the expanded structure as shown, the expandable body is blocked by the legs 7 and cannot be pulled out of the gap 9 by pulling the screw 24 from the head. Therefore, in the expanded structure, the expandable body is fixed to the stem portion 1. Preferably, the expandable body is placed in the expanded structure by fixing the screw 24 to the expandable body. In the present case, when the screw 24 is located in the threaded opening of the expandable body, rotating the screw 24 in a specific rotational direction causes the expandable body to expand mechanically. Rotating the screw 24 in the opposite rotational direction causes the expandable body to contract. Therefore, the expansion of the expandable body can be controlled by the surgeon. When the expandable body is in the contracted structure, the surgeon can introduce the expandable body into the gap 9 through an opening 11, 13 or 15. The surgeon can then rotate the screw 24, thereby placing the expandable body in the expanded structure.

[0174] For example, the expandable body may be an expandable plug, an expandable bolt or an expandable anchor. The screw and the expandable body may together constitute a sleeve anchor.

[0175] In embodiments not shown in the drawings, the implant may include an inner portion including at least one expandable body as disclosed above and at least one fastener, and at least one outer portion is fixed to the inner portion by the fastener.

[0176] Now go to Figure 6 , the implant 60 comprises two outer parts 62 and 63. The phrase "outer parts" preferably refers to the parts 62 and 63 that extend substantially from the gap 9 to the outer part of the surrounding of the stem part 1. Each part 62 and 63 is configured to be fixed to the stem part 1.

[0177] Each portion 62 or 63 comprises a pad 64. When the portions 62 and 63 are mounted on the stem portion 1, the pad 64 wraps around the axis X1 at the level of the gap 9 and / or the epiphyseal end 5 of the stem portion 1. In other words, the portions 62 and 63 have a respective pad 64 located at the periphery of the stem portion 1. Each pad 64 is preferably shaped as a curved sheet or curved portion so that it rotates around the axis X1 when the relative portion 62 or 63 is mounted on the stem portion 1. Figure 6 As shown, the curved sheet or portion is preferably substantially rectangular. For example, the pad 64 can be semi-conical, hemispherical or semi-cylindrical. Preferably, when installed, each pad 64 covers at least 100° of the periphery of the stem portion 1 around the axis X1. Each pad 64 can cover 180° of the stem portion, so that when two pads 64 are installed, the stem portion 1 is covered by the two pads 64 at 360° around the axis X1.

[0178] Preferably, when installed, the inner curved surface 65 of the pad 64 directed toward the stem portion 1 is at least partially in contact with the stem portion 1. In the present example, each pad 64 is positioned along one or two connecting legs 7, in other words, each pad 64 covers one or two connecting legs 7. On the other hand, at least a portion of the shape of the inner curved surface 65 preferably has a shape corresponding to or matching the stem portion 1.

[0179] Preferably, when mounted, each pad 64 at least partially covers one of the openings 11 and 13. In the present example, the openings 11 and 13 are completely covered by two pads 64, respectively.

[0180] Each pad 64 is centered on one of the openings 11 and 13. Each pad 64 has two peripheral ends 64A and 64B. When the outer parts 62 and 63 are installed, the ends 64A preferably touch each other, or at least are in close proximity. When installed, the ends 64A preferably cover the opening 15. When the outer parts 62 and 63 are installed, the ends 64B preferably touch each other, or at least are in close proximity. When installed, the ends 64B preferably cover one of the legs 7 opposite the opening 15.

[0181] In an embodiment not shown, the first pad may have a first material and the second pad may have a second material, the first material and the second material being different from each other.

[0182] A different material may be selected for one of the pads 64 than the other.

[0183] The pad 64 may be manufactured specifically for the patient, ie, be patient-specific. The pad 64 may be obtained by additive manufacturing.

[0184] Each pad 64 can receive one or more epiphyseal fragments 4 on the outer surface 66 of the pad 64. The epiphyseal fragments 4 can be positioned along and against the outer surface 66 to be fixed to the pad 64. For example, the epiphyseal fragments can each be a tubercle of a fractured bone to be reattached. One pad 64 can receive the lesser tubercle, while the other pad 64 can receive the greater tubercle.

[0185] Since the parts 62 and 63 can be fixed to the stem part 1, it is possible to adapt a single stem part 1 to different situations by fixing different kinds of external parts (e.g., parts 62 and 63) to the single stem part 1. In particular, when the stem part 1 is a standard component, the appropriate external part can be selected or manufactured according to the category of the patient or the pathology to be treated or even specifically for a specific patient. Before the external part is fixed to the stem part 1, the epiphyseal fragment 4 can be fixed to the external part, which makes the operation easier.

[0186] The outer portions 62 and 63 are particularly suitable for situations where the epiphyseal fragments are very thin or in poor condition. The pad 64 can actually mechanically support and strengthen these fragile fragments so that they can be safely reintroduced into the patient's body to better allow the patient to heal.

[0187] Alternatively, one or more pads may be shaped to replace one or more epiphyseal fragments, for example when the fragments are non-viable.

[0188] Each pad 64 may be provided with a through hole for receiving a suture for fixing the fragment 4 to the pad 64. Each suture through hole may be arranged from surface 66 to surface 65. Alternatively or additionally, each pad 64 may be provided with a hole for fixing a fastener such as a screw through the pad 64. Each fastener through hole may be arranged from surface 66 to surface 65. Alternatively or additionally, the pad 64 may be provided with holes or pores that promote bone ingrowth. These holes are preferably visible to the naked eye, for example, more than 0.5 mm (millimeter). Alternatively, smaller holes or pores may be provided to produce a similar effect, depending on the application.

[0189] In an embodiment not shown, one or both pads may include a barb integrally formed with the relative pad. The barb may help to better fix the fragment 4 to the relative pad. The barb preferably protrudes outwardly from the pad. The barb preferably protrudes in a direction radial to the axis X1 or slightly obliquely relative to this direction.

[0190] The implant 60 is fixed to the stem portion 1 through the gap 9. Figure 6 In the case of the outer part 62, the outer part 63 includes an arm 68. Both arms 67 and 68 protrude from the inner surface 65 of the relevant part 62 or 63. Arms 67 and 68 are configured to be coaxial when the parts 67 and 68 are fixed to the stem part 1. Each arm 67 and 68 is preferably oriented radially to the axis X1, or at least perpendicular to the axis X1. Arm 67 is inserted into the gap 9 through the opening 11, while arm 68 is inserted into the gap 9 through the opening 13. One or more outer parts can be fixed through other holes (for example, opening 15) leading to the gap 9 and defined by the legs 7. One of the arms 67 and 68 can have a tubular shape so that the other arm is axially inserted into the arm. Arms 67 and 68 can be snap-fitted together to fix the parts 62 and 63 relative to each other. When the parts 62 and 63 are fixed in this way, they are also fixed to the stem part 1 because the shape of the inner surface 65 corresponds to the outer peripheral shape of the stem part 1.

[0191] More generally, in Figure 6In the embodiment of the present invention, the portion 62 constitutes the main outer portion, the portion 63 constitutes the auxiliary portion, the arm 67 constitutes the main fastener, and the arm 68 constitutes the auxiliary fastener, which is complementary. The main fastener 67 is configured to cooperate with the auxiliary fastener 68 to fix the main outer portion 62 to the auxiliary outer portion 63. In other words, the portions 62 and 63 are fixed to each other by the fasteners 67 and 68 so as to be mechanically fixed to the stem portion 1, which is captured between the pads 64. Therefore, the implant 60 is very easy to fix to the stem portion 1.

[0192] In alternative embodiments, implant 60 may include more than two outer portions.

[0193] Now go to Figure 7 , Figure 6 The arms 67 and 68 of the embodiment have been replaced by another type of fastener. The arm 67 is replaced by a screw 77, and the arm 68 is replaced by an internally threaded tube 78, so that the fastener 77 is preferably fixed to the tube 78 by tightening the screw in the threaded tube. Figure 6 Other features of the implant disclosed in Figure 7 implementation method.

[0194] exist Figure 8 In an embodiment, implant 80 includes an inner portion 82, which can have the same features as the inner portion disclosed above, especially inner portion 22.

[0195] The implant 80 also includes an outer portion 83 that is different from the inner portion 82. The outer portion 83 may have the same Figure 6 or Figure 7 The same features as the outer portion 62 or 63 disclosed in Figure 8 In the case of the outer portion, the outer portion has an arm or fastener 87 protruding from the inner surface 85 of the pad 84 and is fixed to the receiving hole 88 of the inner portion 82. This fixation is preferably achieved by snap-fitting the arm 87 into the hole 88. Other fixing means may be provided, such as threaded fastening or press fit.

[0196] Similar to the pad 64 described above, the pad 84 of the present example has a rectangular shape and is bent around the stem portion 1 about the axis X1 .

[0197] exist Figure 8 In the present case, implant 80 combines the advantages of the above-mentioned internal part and external part.

[0198] exist Figure 8In the case of the outer part 83 is fixed to the inner part 82, the arm 87 passes through the opening 15. In alternative embodiments, the outer part 83 can be fixed through any other hole defined by the leg 7. The implant 80 may include more than one outer part fixed to the inner part through the corresponding opening 11, 13 or 15. In the present example, the pad 84 completely covers the opening 15. Alternatively, the opening 15 can be only partially covered. However, the openings 11 and 13 are not completely covered by the pad 84, or even completely free.

[0199] Now turn to Fig. 9 , the stem 1 is provided with an implant 90 comprising one or more external parts 92. Each external part 92 comprises one or more yarns or threads 94, each yarn forming a loop. Each yarn 94 may have a knot 95 for closing the loop. Each yarn 94 is arranged to surround at least one connecting leg 7 by passing through at least two of the openings 11, 13 and 15, or at least through the gap 9. In the present case, the yarn 94 passes through the openings 15 and 13. Each yarn 94 carries at least one button 96, preferably two buttons 96. The buttons 96 are positioned at the periphery of the gap 9 at the height of the connecting leg 7 along the axis X1. The buttons 96 are preferably arranged at opposite ends of the loop formed by the yarn 94. The yarn 94 is preferably tensioned so as to tend to make the buttons 96 face each other. One or more epiphyseal fragments 4 can be inserted between the first button 96 and the stem 1. As the yarn 94 is tightened, these fragments 4 are fixed to the stem 1 because they are caught between the button 96 and the stem 1. Preferably, the relevant fragments 4 are arranged along the connecting leg 7 and / or along the epiphyseal end 5 of the stem 1. One or more additional epiphyseal fragments 4 may be inserted between the second button 96 and the stem 1. Thus, if Fig. 9 As shown, these additional pieces 4 are caught between the second button 96 and the radially opposite side of the stem 1 compared to the first button 96. The yarn 94 preferably passes through the attached pieces 4. For specific applications, one of the buttons 96 can be omitted, and one of the pieces 4 is inserted between a portion of the yarn 94 and the stem 1 similar to a suture.

[0200] In addition to or as an alternative to the outer part 92, the implant 90 may include one or more outer parts 93. Each outer part 93 includes one or more yarns 97, each forming a loop. Each yarn 97 may have a knot 98 for closing the loop. Each yarn 97 is arranged to surround at least one connecting leg 7. In the present case, the yarn 94 passes through the openings 11 and 15 and surrounds one leg 7. Each yarn 97 carries at least one button 99, preferably only one button 99. The button 99 is positioned at the periphery of the gap 9 at the height of the connecting leg 7 along the axis X1. The yarn 97 is preferably tensioned so as to tend to make the button 99 towards the leg 7 to which the yarn is attached. One or more epiphyseal fragments 4 can be inserted between the button 99 and the leg. With the tension of the yarn 97, these fragments 4 are fixed to the stem 1 because they are stuck between the button 99 and the leg 7. The relevant fragment 4 is thus arranged along the connecting leg 7 and / or along the epiphyseal end 5 of the stem portion 1. The yarn 97 preferably passes through the attached fragment 4.

[0201] To attach the fragment 4, the surgeon can position the fragment 4 along the trunk portion 1, pass the yarn through the fragment 4, and also position a button on the fragment 4. The surgeon can tie a knot 95 or 98 to form a loop with the yarn 94 or 97. Once the loop is formed, the surgeon can activate a tensioner integrated into a button 96 or 99 to tension the passed yarn 94 or 97. The tensioner of the button 96 or 99 is preferably a mechanical tensioner. For example, the tensioning function of the button can be obtained by an expandable button, tying a knot 95 or 98 when the button is in a contracted configuration, and then the surgeon tightens the button into an expanded configuration to mechanically tension the yarn.

[0202] exist Fig.10 , Fig.11 and Fig.12 In an embodiment, implant 100 includes an inner portion 102, preferably having the features described for the other inner portions disclosed above.

[0203] The inner part 102 differs from the other inner parts disclosed above in that the inner part 102 comprises a peripheral shell 103 and a core 104 received within the peripheral shell 103. Thus, in this case, the inner part 102 is not made of a single integral part, but of at least two different combined parts: the shell 103 and the core 104.

[0204] The housing 103 is preferably positioned completely within the gap 9, between the legs 7, and between the rod 3 and the end 5. In some embodiments, such as Fig.10 In the case of, for example, the housing 103 may partially extend out of the gap 9 through one or more of the openings 11, 13 and 15. However, in this case, the housing 103 is preferably mostly enclosed in the gap 9. Fig.10 In the embodiment, the housing extends out of the gap 9 through the opening 15 .

[0205] The housing 103 is preferably made of one integral part, in other words, a single piece. The housing 103 is preferably made of a softer material than the material of the stem 1 .

[0206] The material of the housing 103 is preferably the material defined above for the inner portion 22 and the pad 64 .

[0207] In the most preferred embodiment, the housing 103 comprises a biological material as defined above. The housing 203 may also comprise a degradable material and a non-degradable material. For example, the degradable material may include, but is not limited to, polyesters, polyanhydrides, polyurethanes, and polysaccharides. Alternatively, the material may be one of the materials defined above.

[0208] Preferably, the shape of the housing 103 corresponds to the shape of the gap 9 so that the inner part 102 can fit into the gap 9 .

[0209] Preferably, the housing 103 is mounted into the gap 9 through the opening 15. Preferably, the housing 103 is mounted by press-fitting.

[0210] In another embodiment, the housing 103 can be fixed to the stem part 1 by snap-fitting or clamping the stem part 1 in the gap 9. Advantageously, the housing 103 can also be detached from the stem part 1. In order to achieve the snap-fitting or clamping of the housing 103, the gap 9 is optionally provided with protrusions or recesses that interact with protrusions or recesses of the housing 103. With this embodiment, the positioning of the housing 103 in the gap 9 is made very easy and particularly reliable.

[0211] The housing 103 can be manufactured specifically for the patient, that is, it is dedicated to the patient. The housing 103 can be obtained by additive manufacturing.

[0212] The inner part 102 including the shell 103 and having the desired shape can be implemented in the stem 1 to adapt the prosthesis P to different applications. For example, by combining the stem with an implant dedicated to the right shoulder or an implant dedicated to the left shoulder, a left shoulder prosthesis and a right shoulder prosthesis with the same reference stem can be obtained. Therefore, fewer stem references are required.

[0213] The housing 103 includes a cavity or hole for receiving the core 104. Preferably, the cavity has at least one opening 105 through which the surgeon can position the core 104 into the cavity of the housing 103. In the example shown, two opposing openings 105 are provided, although in Fig.10 and Fig.11 Only one of them can be seen. Preferably, Fig.10In the case of the embodiment of the present invention, when the inner part 102 is positioned in the gap 9, each opening 105 is at least partially blocked by one or more legs 7, so that when the implant 100 is positioned in the gap 9, the core 104 does not migrate out of the cavity of the shell 103. Preferably, in this case, the opening 105 is not completely blocked, so that when the prosthesis P is implanted in the patient's body, the core 104 contacts the patient's body tissue or body fluid.

[0214] exist Fig.10 , Fig.11 and Fig.12 In the example shown, the housing 103 has a prismatic shape with a trapezoidal base. At both bases of the prismatic shape, openings 105 are provided. The openings 105 and the cavity of the housing 103 can be considered as a through opening of the housing 103 along the axis X105, containing the core 104. The axis X105 is intended to be perpendicular to the axis X1.

[0215] The housing 103 of the present example has four peripheral surfaces 103A, 103B, 103C and 103D surrounding the opening 105 and parallel to the axis X105 .

[0216] When the implant 100 is fixed in the gap 9, at least two of the surfaces 103A, 103B and 103C, preferably all of the surfaces, abut against three corresponding inner walls of the gap 9. The surface 103B may abut against an inner wall formed by one leg 7, which is opposite to the opening 15. The surface 103A adjacent to the surface 103B may abut against an inner wall formed by the epiphyseal end 5. The surface 103C adjacent to the surface 103B and opposite to the surface 103A may abut against an inner wall formed by the rod 3. The surface 103D adjacent to the surfaces 103A and 103C and opposite to the surface 103B extends so as to fill the opening 15. Preferably, the surfaces 103A and 103B may extend parallel to or at a slightly inclined angle relative to the axis X1, while the surfaces 103A and 103C are transverse.

[0217] exist Fig.10 As can be seen from the figure, the surface 103D can extend outwardly from the gap 9 along the two legs 7 around the opening 15. Therefore, the surface 103D can constitute the outer surface of the housing 103.

[0218] The shape of the housing 103 (including the surfaces 103A, 103B, 103C, and 103D) may be applied to Figure 1 and Figure 2 The inner portion 22 may include an inner portion 22 , although the inner portion 22 does not have a through opening like the opening 105 .

[0219] The core 104 preferably comprises a bone graft. Preferably, the bone graft of the core 104 is an autologous bone graft, such as an original head of a long bone at least partially formed with an attached prosthesis P. The bone graft may also be an autologous iliac bone graft. Any other type of bone graft may be used depending on the application.

[0220] Since the bone graft core 104 is received in the housing 103, the inner part 102 combines the advantages of having a bone graft, which can allow the patient to heal better, with a very precise shape provided by the shape of the housing 103. In order to be introduced into the housing 103, the bone graft core 104 does not need to have a very precise shape, which can save time especially in the case of autogenous bone graft, which can be extracted and recut during surgery. Therefore, the inner part 102 is very easy to install and fix on the trunk part 1, making the operation easier.

[0221] exist Fig.12 As can be seen from the figure, a series of holes 108 smaller than the opening 105 can be provided on one or more of the surfaces 103A, 103B, 103C, and 103D to promote bone ingrowth. Each relevant surface 103A, 103B, 103C, and 103D can have a plurality of such holes 108. Each of these holes can lead to the inner cavity of the housing 103.

[0222] exist Fig.11 and Fig.12 As can be seen above, the housing optionally includes barbs 107 disposed on a surface 103D, which is external. Surface 103D may be used to secure epiphyseal bone fragments.

[0223] Fig.13 , Fig.14 and Fig.15 Another embodiment is depicted in which an implant 110 has substantially the same features as implant 100, with some differences described below. In particular, implant 110 includes an inner portion 112, which includes a shell 113 and a core 114 located within shell 113. Similar to shell 103, shell 113 has one or two opposing openings 115 leading to the inner cavity. Unlike shell 103, shell 113 includes an opening 116 leading to the inner cavity of shell 113, which is located at the inner cavity of shell 113. Fig.15 The opening 116 is provided on a portion of the housing 113 that preferably protrudes outside of the gap 9 through the opening 15 of the stem portion 1. In the present case where the housing 113 is identical to the housing 103, the opening 116 is provided through the surface 103D, leading to the inner cavity of the housing 113. Thus, when the housing 113 is installed in the gap 9, the Fig.13 As can be seen from the figure, the opening 116 is not obstructed by any leg 7. Fig.13 , Fig.14 and Fig.15 As shown, the bone graft core 114 can partially protrude from the housing 113 through the opening 116. This can promote healing of the patient. In particular, one or more epiphyseal fragments can be fixed on the protruding core 114.

[0224] exist Figures 13 to 15 In the example shown in FIG. 1 , the surface 103D does not have the barbs 107 and the holes 108 described above.

[0225] In the case where the opening 116 is provided to the housing 113 , the opening 115 is optional. Therefore, the housing 113 may have only the opening 116 without the opening 115 .

[0226] Fig.16 An additional embodiment is depicted in which implant 110A has substantially the same features as implant 110, with some differences described below. Fig.16 It is shown in Fig.15 The implant 110 is oriented in the same manner. Fig.16 In the example, Figures 13 to 15 In contrast, the surface 103D of the housing 113 is provided with barbs 107A which are provided to surround the opening 116A. Fig.17 , Fig.18 and Fig.19 An embodiment of an implant 120 having a modification compared to the implant 100 is shown. As with the implant 100, the implant 120 includes an inner portion 122, which includes a shell 123 and a core 124 located within the shell 123. The shell 123 has two opposing openings 125 through which the core 124 is positioned, which define a transverse axis X125 of the shell 123, similar to the opening 105 and the axis X105. The inner portion 122 has the same features and shape as the inner portion 102 disclosed above, with some differences described below.

[0227] The implant 120 comprises an outer part 127 fixed to the shell 123. More precisely, the part 127 is fixed to the surface 103D of the shell 123, or replaces the surface 103D. The outer part 127 is preferably integral with the shell 123. Therefore, the outer part 127 can be considered as a part of the shell 123. The outer part 127 is preferably made of the same material as the shell 123. One or more outer parts similar to the part 127 can be provided for the implant 120.

[0228] For example, “outer” preferably means that portion 127 extends substantially from gap 9 to the surrounding exterior of stem portion 1 similar to portions 62 and 63 .

[0229] The outer portion 127 comprises a single pad. The pad of portion 127 may have all of the features of pad 64 disclosed above. Fig.17 When the implant 120 is mounted on the stem 1 as shown, the portion 127 preferably extends along the stem 1 around the axis X1 at the level of the gap 9 and / or the epiphyseal end 5. In other words, the portion 127 is located at the periphery of the stem 1.

[0230] In the example shown, the portion 127 has a generally rectangular shape and is slightly curved around the axis X125 to match the shape of the stem 1. The portion 127 is preferably shaped as a curved sheet. In the present case, the portion 127 extends along the two legs 7, preferably completely covering the opening 15. Preferably, the portion 127 extends to the proximal side of the epiphyseal end 5.

[0231] Preferably, portion 127 has a shape matching that of stem portion 1. Preferably, portion 127 comprises a side 129 in contact with stem portion 1. Side 129 is preferably opposite to the outwardly directed side 124A of portion 127. Portion 127 preferably covers only a portion of stem portion 1 around axis X1.

[0232] One or more epiphyseal bone fragments may be secured to the stem portion 1 to abut against portion 127. Optionally, portion 127 may be provided with holes or through-holes 126 similar to holes 108, for example, to promote bone ingrowth.

[0233] The outer portion 127 may include integrally formed barbs 128. The barbs 128 preferably protrude outwardly at the periphery of the stem portion 1. These barbs 128 preferably protrude substantially radially relative to the axis X1. Thus, the barbs 128 may help to better secure the fragment 4 to the stem portion 1. In the present example, the barbs 128 are provided at the side 124A. In an embodiment where no barbs are provided, the side 124A may remain bare.

[0234] More generally, implant 120 may include barbs positioned along an outer portion integrally formed with the housing. Preferably, the barbs are positioned outside the housing rather than in the inner cavity of the housing. "Outer portion" means that the outer portion is substantially or even completely positioned outside of gap 9.

[0235] Figure 20 to Figure 23 An implant 130 is shown comprising an outer portion 131. The portion 131 extends substantially from the gap 9 to the surrounding exterior of the stem portion 1.

[0236] like Fig. 20 and Fig.21 As shown, when the portion 131 is mounted on the stem 1 , the portion 131 has a central body 135 located outside the gap 9 and covering the opening 15 .

[0237] The portion 131 preferably has two wings 133 extending on either side of a central body 135 and both wrapping around one side of the stem portion 1 around the axis X1. The wings 133 extend around the stem portion 1 around the axis X1. The openings 11 and 13 of the gap 9 are at least partially, preferably completely, covered by the wings 133. The wings 133 and the body 135 preferably wrap or restore an essential portion of the periphery of the stem portion 1 around the axis X1. The wings 133 and the body 135 preferably extend along the axis X1 to the epiphyseal end 5 so as to cover an essential portion of its peripheral wall around the axis X1.

[0238] Preferably, Fig.21 As can be seen in the figure, portion 131 leaves only a small part of the stem 1 uncovered around axis X1. At the opposite ends of the central body 135 around axis X1, the ends of the two wings 133 advantageously define a gap 132 where one leg of the stem 1 is at least partially visible from the outside. Due to the provision of gap 132, the stem 1 is only partially enclosed by portion 131 around axis X1.

[0239] The outer part 131 is configured to be fixed to the stem 1, the two wings 133 acting as locators of the part 131 along the axis X1 onto the stem 1. The wings 133 and the body 135 advantageously define an axial through opening 139 of the outer part 131. When the part 131 is mounted on the stem 1, the stem 1 is located inside this through opening 139, which extends parallel to the axis X1. Figure 20 to Figure 23 In the embodiment, since the slit 132 is arranged along the through opening, the through opening is not absolutely tubular.

[0240] The outer portion 131 also includes ribs 134 protruding from the central body 135 between the wings 133 (at Fig. 22 13). The rib 134 protrudes within the opening 139. The rib 134 is preferably diametrically opposed to the gap 132. Fig. 20 and Fig.21 As shown, when portion 131 is mounted on stem 1, rib 134 is inserted through opening 15 into gap 9. When rib 134 is positioned in opening 15, rib 134 may be formed to enable portion 131 to be axially and rotationally fixed relative to stem 1 and relative to axis X1.

[0241] To assemble the stem 1 and the outer part 131, the through opening 139 is configured so that the stem 1 can be axially inserted into the through opening 139, the rod 3 is first placed and slid along the axis X1 until the end 5 is inserted into the opening 15 of the stem 1 against the wing 133 and / or the rib 134 axially. Thus, the installation of the outer part 131 is very convenient and can save surgical time.

[0242] Preferably, the body 135, wings 133 and optional ribs 134 form a single integral piece.

[0243] Preferably, the outer part 131 comprises a peripheral shell, thereby comprising at least a central body 135. Preferably, the peripheral shell also comprises wings 133 and ribs 134. The shell and Fig.21 The rest of the prosthesis P is shown separately. The peripheral shell includes an inner cavity disposed within the central body 135. Fig. 20 As shown, an opening 136 leading to the inner cavity is provided on the central body 135. This opening 136 is preferably directed radially outwards, for example opposite to the rib 134, so as to be accessible when the portion 131 is mounted on the stem portion 1.

[0244] The inner cavity can accommodate a bone graft core 137. Preferably, the bone graft core 137 has the same features as mentioned for the core 104 disclosed above. Fig. 20 and Fig.21 In the case of the core 137 can be slightly protruded from the opening 136, in order to facilitate the fixation of the epiphyseal fragments to the prosthesis P.

[0245] like Fig.23 As shown, instead of opening 136, two separate openings 136A and 136B may be provided to accommodate two different bone graft cores 137 in two separate cavities of the outer portion, respectively.

[0246] The outer portion 131 is preferably configured so that a tubercle fragment reattached to the stem portion 1 can rest against the outer portion 131. To this end, the outer peripheral shape of the outer portion preferably mimics the shape of the epiphyseal portion of a fractured bone. In the example shown, the respective peripheral surfaces 133A and 133B of the wing portions 133 are shaped to carry a respective tubercle fragment. The surface 133A of the first wing portion 133 is shaped to receive a greater tubercle fragment, while the surface 133B of the second wing portion 133 is shaped to receive a lesser tubercle fragment. Thus, as shown in FIG. Fig.23 As best seen in FIG. 1 , the shapes of surfaces 133A and 133B of wing 133 may be asymmetrical to one another, depending on the nodule fragment to be reattached thereto.

[0247] The outer portion 131 is particularly suitable for reattaching thin or fragile tubercle fragments. Once reattached, such fragments are structurally supported by the wings 133.

[0248] Depending on the shape of the portion 131 fixed to the stem portion 1, a single type of stem portion 1 can be used in different situations. Figure 20 to Figure 23 If a portion having a symmetrical shape such as the portion 131 shown is assembled to the same stem portion 1, the prosthesis can be used to heal a symmetrical fractured long bone of a patient.

[0249] The peripheral shell of part 131 may be of the same material as mentioned for the peripheral shell disclosed above, preferably one of the above-mentioned biomaterials. The peripheral shell may have barbs as mentioned for the peripheral shell disclosed above, for example barbs protruding outwardly from the wings and / or from the central body. The peripheral shell is preferably provided with a series of macroscopic through openings or blind holes formed in the wings 133 leading to the outside to promote bone ingrowth. "Macroscopic" means that the size of the holes may exceed 0.5 mm. On the contrary, smaller holes or pores may be provided to produce a similar effect, depending on the application.

[0250] In one embodiment, the implant 130 includes one of the inner parts described above for other embodiments in addition to the outer part 131. In this case, the inner part is fixed in the gap 9. The outer part 131 is advantageously fixed to the inner part preferably by one or more fasteners passing through one opening 11, 13 or 15.

[0251] Figure 24 to Figure 26 An implant 140 is shown including an outer portion 141. The outer portion 141 includes substantially the same features as portion 131 of the implant 130, preferably including two wings 143, a central body 145, an axial through opening 149, a slit 142, a rib 144, an inner cavity disposed within the central body 145, and an opening 146 leading to the inner cavity. Fig.24 , a bone graft core 147 is shown positioned within the cavity through opening 146. Fig.26 Upper cavity and opening 146 are free of a bone graft core.

[0252] The implant 140 differs from the implant 130 in that two additional blind holes, through openings or recesses 14 are provided by the wings 143. Fig.16 and Fig.17 As shown, each of these holes 148 can be used to receive a bone graft core 150. Preferably, as shown in FIG. Fig.24 and Fig.26 As shown, each of the two holes 148 opens on the same side of the component 141 as the opening 146 (i.e., the side opposite to the gap 142). Fig.25 As can be seen in FIG. 1 , each of the two holes 148 is also open within the opening 149 along the inner side of the wing 143 .

[0253] Only one hole 148 may be provided. If at least one hole 148 is provided, the lumen and opening 146 may be optional, depending on the application.

[0254] Furthermore, the respective peripheral surfaces 143A and 143B of the wings 143 are preferably shaped as cylinders with a circular base along the axis X143. In the example shown, the axis X143 is oriented obliquely relative to the axis X1, passing substantially through the centre of the spherical shape of the prosthetic head 6, if such a head is provided.

[0255] Fig. 27 and Fig.28 An implant 180 is shown including an outer portion 181. The outer portion 181 is Fig. 27 and Fig.28 As shown above, they have Fig. 22 and Fig.23 The portion 131 on the top has a similar three-dimensional orientation.

[0256] The outer portion 181 comprises substantially the same features as the portion 131 of the implant 130, preferably including two wings 183, a central body 185, an axial through opening 189, a slit 182, a rib 184, two lumens arranged in the central body 185 and two corresponding openings 186 leading thereto. Fig.28 1 , two bone graft cores 187 are shown positioned within the cavity through openings 186.

[0257] The implant 180 is substantially different from the implant 130 in that the surface of the component 181 has no macroscopic holes. Instead, the surface of the component 181 is rough or uneven to promote bone clamping. As an alternative to the rough surface or in addition to the rough surface, depending on the application, the component 181 can also be provided with barbs for producing a similar effect.

[0258] and Figure 20 to Figure 23 Another difference of the embodiment of the present invention is that each wing 183 includes a corresponding slot 190. Each slot 190 can be used to accommodate bone fragments, bone cement material or bone graft. Each accommodated element can be radially around the axis X1 against the epiphyseal end 5 of the stem portion 1. Each slot 190 is open to the gap 182 in a symmetrical arrangement relative to each other. As shown in the figure, each slot 190 is preferably triangular or V-shaped. Fig.29 An embodiment of a prosthesis P is depicted comprising an implant 160 having an external part 161 which may have the same features as part 131 or part 141, in particular with regard to the materials used, the method of fixing part 161 to stem part 1 and the fact that a bone graft core may be fixed in its cavity. Instead of part 131 or 141, external part 161 may be used in the implant.

[0259] The outer part 161 envelops the stem 1 around the axis X1, preferably without a slot like the slots 132 or 142. The part 131 comprises an axial through-opening 169 having a similar function to the openings 139 or 149. The opening 169 is shaped corresponding to the contour of the stem 1, i.e. in a T-shape. The opening 169 has a closed contour, since no slot like the slots 132 or 142 is provided. In this case, when the stem 1 is inserted into the outer part 161, it is enveloped by the outer part 161, forming a sleeve around the axis X1.

[0260] Regardless of the embodiment, all or part of the implant may be obtained by additive manufacturing. In the case where the implant is made of a single integral part or a plurality of assembled integral parts, the implant may be completely obtained by additive manufacturing.

Claims

1. A prosthesis for a fractured long bone, the prosthesis comprising: a rod configured to be inserted into the medullary cavity of the diaphyseal fragment of the fractured long bone to secure the prosthesis to the diaphyseal fragment; an epiphyseal end fixedly fixed to the rod by a plurality of connecting legs, so that a gap is formed between the epiphyseal end and the rod along the plurality of connecting legs; as well as A plurality of barbs are spaced apart by grooves on a proximal portion of the prosthesis, wherein the barbs project outwardly from an exterior side of the prosthesis.

2. The prosthesis according to claim 1, further comprising: Internal part; as well as a stem portion including the rod, the epiphyseal end and defining the gap, Wherein, the inner portion is configured to be located at least partially within the gap in the stem portion.

3. The prosthesis according to claim 1, further comprising a stem portion and an implant body detachable from the stem portion, the plurality of barbs being disposed on a side surface of the implant body.

4. The prosthesis according to claim 1, further comprising a suture fixing portion formed in at least one connecting leg among the plurality of connecting legs, the suture fixing portion being disposed in the vicinity of the epiphyseal end.

5. The prosthesis of claim 4, wherein the suture fixation portion comprises a through hole.

6. The prosthesis of claim 1, wherein a hole is defined in the proximal portion of the prosthesis for positioning a screw therein such that the screw is oriented in an anterior or posterior direction.

7. A prosthesis for a fractured long bone, the prosthesis comprising: a rod configured to be inserted into the medullary cavity of the diaphyseal fragment of the fractured long bone to secure the prosthesis to the diaphyseal fragment; an epiphyseal end fixedly fixed to the rod by a plurality of connecting legs, so that a gap is formed between the epiphyseal end and the rod along the plurality of connecting legs, Wherein, a plurality of grooves are formed on the outer side of the epiphyseal end of the prosthesis.

8. The prosthesis according to claim 7, further comprising an implant body, the plurality of grooves being formed on an outer side of the implant body opposite to an inner side of the implant body, the inner side of the implant body being insertable into the opening on the outer side of the prosthesis.

9. A system comprising the prosthesis of claim 7, further comprising a screw configured to extend from a first outer surface of the humerus along a screw trajectory through the prosthesis to a second outer surface of the humerus opposite the first outer surface.

10. The system of claim 9, wherein the screw is configured to extend in an anterior-posterior direction from an anterior external surface of the humerus through the prosthesis to a posterior external surface of the humerus.

11. The system of claim 9, wherein the screw trajectory is disposed in a proximal portion of the prosthesis.

12. The system of claim 9, wherein the screw trajectory is within a portion of the gap.

13. A method for repairing a humeral fracture, comprising: The rod of the prosthesis is inserted into the medullary cavity of the diaphyseal fragment of the humerus, the prosthesis comprising: an epiphyseal end portion disposed opposite to the rod, the epiphyseal end portion being fixedly fixed to the rod via a plurality of connecting legs, thereby forming a gap between the epiphyseal end portion and the rod along the plurality of connecting legs; and a plurality of barbs spaced apart by a plurality of grooves on a proximal portion of the prosthesis, wherein the barbs project outwardly from an exterior side of the prosthesis; securing the one or more epiphyseal fragments of the humerus to the prosthesis by placing the one or more epiphyseal fragments of the humerus over the plurality of grooves; and Sutures placed around or through the one or more epiphyseal fragments are secured on a surface opposite the outside of the prosthesis.

14. The method of claim 13, wherein the surface comprises a concavity of an epiphyseal end. The method of claim 14 , wherein the concave surface comprises a portion of a through hole.

16. The method of claim 15, wherein the through hole is formed in one of the connecting legs.

17. The method of claim 13, further comprising advancing a screw along an anterior-posterior trajectory through the prosthesis.

18. The method of claim 17, wherein the anterior-posterior trajectory is disposed through a proximal portion of the prosthesis.

19. The method of claim 17, further comprising advancing the screw along a trajectory through an implant disposed in a gap of the prosthesis.

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