Temporary spacer device for human joints

Abstract

A temporary spacer device (10) for a human joint comprises: a first component or femoral component (12) which is suitable for being constrained to a patient's bone or femur at a human joint such as a knee joint during use; a second component or tibial component (14) which is suitable for being constrained to a patient's bone or tibia at a human joint such as a knee joint during use; and at least one rod (22, 24) having a proximal end (25), wherein the first component or femoral component (12) and / or the second component or tibial component (14) comprises at least one receiving seat (23, 27) for the proximal end (25) of at least one rod (22, 24) which is suitable for allowing tilting and / or rotation of the at least one rod (22, 24) relative to an insertion axis (X) of the proximal end (25) in the at least one receiving seat (23, 27).

Description

Technical Field

[0001] The present invention relates to a spacer device which is able to replace an infected joint prosthesis at least for a certain period of time or temporarily.

[0002] More particularly, the present invention relates to a spacer device provided with a rod. Background Art

[0003] It is well known that in joint prostheses present in anatomical areas of the human body, such as joints, infection or damage may occur, necessitating removal of the prosthesis itself.

[0004] At the moment of removal of the prosthesis, it is now common practice to insert in its place a joint spacer device of a temporary nature, which remains in the implantation site during the time between the removal of the infected or damaged prosthesis and the implantation of a second prosthesis.

[0005] The spacer device may include one or more drugs or medical substances, such as one or more antibiotics, to treat a current infection at the site of previous insertion of the removed prosthesis.

[0006] During this time, the spacer device also maintains the joint space at the implant site, avoiding any shortening or shrinkage of the surrounding tissue that might occur in the absence of the spacer device itself while removing the first prosthesis and then waiting for the site of concern to heal before implanting a new prosthesis.

[0007] This procedure is known as a "two-stage implant" of the joint prosthesis.

[0008] Also known are modular spacer devices which are available in different sizes or dimensions in order to adapt as closely as possible to the anatomical dimensions of the patient.

[0009] These spacers are pre-formed and have predetermined sizes, so the possibility to combine various components of different sizes allows the surgeon to select the most appropriate spacer device based on the specific surgical needs. Summary of the invention

[0010] The present invention proposes the technical task of improving the prior art in the field of spacer devices for human joints.

[0011] Within the scope of this technical task, the invention has for its object a spacer device for a human joint, such as a knee joint, provided with at least one rod for connection to a human bone around the joint in question.

[0012] It is a further object of the present invention to provide a spacer device for a human joint which can be adapted to the surgical needs of the patient.

[0013] It is a further object of the present invention to provide a spacer device for a human joint that allows for stable articulation of the patient's bones about the associated joint.

[0014] According to one aspect of the present invention, a spacer device for a human joint is provided.

[0015] Preferred and advantageous embodiments of the invention are also described. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Other features and advantages of the invention will become apparent from the detailed non-exclusive description of exemplary embodiments of a spacer device for a human joint according to the invention given by way of non-limiting example in the accompanying drawings, in which:

[0017] Figure 1 is a perspective view of components of a spacer device according to the present invention, in a not fully assembled form;

[0018] Figure 2 yes Figure 1 A perspective view of the components of the spacer device in an assembled form;

[0019] Figure 3 yes Figure 1 and 2 a perspective view of components of a spacer device in FIG. 1 , illustrating its operation;

[0020] Figure 4A is a perspective view of a spacer device according to the present invention, in an assembled form;

[0021] Figure 4B yes Figure 4A A partially cutaway perspective view of a spacer device in FIG.

[0022] Figure 5A is a perspective view of a spacer device according to the present invention, in a not fully assembled form;

[0023] Figure 5B yes Figure 5A A partially cutaway perspective view of a spacer device in FIG.

[0024] Figure 6 is an enlarged detail view of a component of a spacer device according to the present invention;

[0025] Fig. 7A and 7B are front views of a rod of a spacer device according to the invention, in a version including and not including filling material, respectively. DETAILED DESCRIPTION

[0026] With reference to the drawings, a spacer device for a human joint, such as a knee joint, according to the present invention is generally indicated by reference numeral 10 .

[0027] The spacer device 10 includes a first component or femoral component 12 and a second component or tibial component 14 .

[0028] The first or femoral component 12 is adapted to be constrained, in use, to a patient's bone or femur, for example at the knee joint.

[0029] The second or tibial component 14 is adapted to be constrained, in use, to the patient's bone or tibia, for example at the knee joint.

[0030] Hereinafter, reference will be made to the femoral component 12 and the tibial component 14 , but it will be understood that in a more general sense, the first component 12 and the second component 14 for human joints other than the knee joint are also included.

[0031] The femoral component 12 is adapted to be pivotally connected to the tibial component 14 during use.

[0032] The spacer device 10 according to the invention further comprises at least one rod 22 , 24 , for example a first rod 22 and a second rod 24 .

[0033] According to one version of the invention, the first stem 22 is placed at the femoral component 12 and / or the second stem 24 is placed at the tibial component 24, or vice versa.

[0034] The femoral component 12 has a generally “C”-shaped configuration (considering a top plan view thereof) and / or a generally U-shaped configuration (considering a side view thereof).

[0035] In addition, for example in Figure 1 and 2 As can be seen, the femoral component 12 includes a first surface 13 adapted to face and / or be constrained to a bone of a patient, such as the femur at the knee joint, in use, and a second surface 15 adapted to face the tibial component 14 in use.

[0036] Similarly, for example in Figure 5A and 5B As can be seen, the tibial component 14 includes a first surface 17 adapted to face and / or be constrained to a bone of a patient, such as the tibia at the knee joint, in use, and a second surface 19 adapted to face the femoral component 12 in use.

[0037] According to one version of the invention, for example, Figure 4A , 4B As shown in FIGS. 5A and 5B , the insert 16 may be inserted between the first surface 17 and the patient's bone.

[0038] In more detail, considering a side view thereof, the first surface 13 of the femoral component 12 has a concave, generally "U" shape.

[0039] Similarly, the shape of the second surface 15 of the femoral component is substantially similar but opposite, ie convex, to the shape of the first surface 13. Considering its side view, the second surface 15 also has a substantially "U" shape.

[0040] On the first surface 13 of the femoral component 12 there is a receptacle 23 (or first receptacle 23 ) for at least one rod 22 , 24 , in particular for example for the first rod 22 .

[0041] According to one version of the present invention, the receiving seat 23 has a cavity 23 ′.

[0042] According to one embodiment, the housing seat 23 may include a housing wall 23 ″. The housing wall 23 ″ delimits the cavity 23 ′. Alternatively, the latter may be delimited directly into the body of the femoral component 12 without affecting the second surface 15 suitable for precisely pivoting with the tibial component 14 .

[0043] In this case, the receptacle 23 can be obtained directly on the femoral component 12 .

[0044] According to at least one version of the invention, the receptacle 23 may be formed integrally with the femoral component 12 .

[0045] In versions where a containment wall 23 ″ is present, it extends away from the first surface 13 and / or towards the patient's bone.

[0046] The spacer device 10 according to the invention may, in addition to or instead of the above, have a receptacle 27 (or a second receptacle 27 ) on the first surface 17 of the tibial component 14 for at least one rod 22 , 24 , in particular for example for a second rod 24 .

[0047] According to one version of the present invention, the receiving seat 27 has a cavity 27 ′.

[0048] According to one embodiment, the housing seat 27 may include a housing wall 27 ″. The housing wall 27 ″ delimits the cavity 27 ′. Alternatively, the latter may be delimited directly into the body of the tibial component 14 without affecting the second surface 19 suitable for precisely pivoting with the femoral component 12 .

[0049] In versions where a containment wall 27 ″ is present, it extends away from the first surface 17 and / or toward the patient's bone.

[0050] In at least one version of the invention, the features of receptacle 23 and the features of receptacle 27 may be similar.

[0051] The femoral component 12 has an anterior portion 12 ′ adapted to be positioned in use at the anterior portion of a patient's knee joint, and two posterior projections 12 ″ adapted to be positioned in use at the posterior portion of a patient's knee joint.

[0052] The two rear protruding portions 12 ″ correspond to the free ends of the planar “C”-shaped configuration of the femoral component 12 .

[0053] Between the two rear protrusions 12 ″ there is a recess 12 a . The recess 12 a extends away from the rear portion of the femoral component 12 until approximately the central portion of the femoral component 12 itself.

[0054] The central portion of the femoral component 12 corresponds to the portion thereof comprised between an anterior portion 12 ′ extending substantially vertically upwards in use and two posterior projecting portions 12 ″ which also have a slightly upwardly sloping course.

[0055] The central portion may be substantially flat or have a slight curvature.

[0056] In the region of the central portion between the recess 12 a and the front portion 12 ′, a receiving seat 23 is placed.

[0057] In one version of the invention, in combination with or in lieu of the one described above, tibial component 14 has a substantially "C" shaped configuration (considering a top plan view thereof) and / or a substantially constant thickness.

[0058] The first surface 17 of the femoral component 14 has a substantially flat or slightly curved pattern and is adapted to be pivotally connected to the second surface 15 of the femoral component 12 .

[0059] The second surface 19 of the tibial component 14 is also substantially planar.

[0060] Similar to the above, in the tibial component 14 one can identify an anterior portion 14 ′ adapted to be positioned in use in the anterior part of a patient's knee joint and two posterior extensions 14 ″ adapted to be placed in use in the posterior part of a patient's knee joint.

[0061] The two rear extensions 14 ″ correspond to the free ends of the planarly configured “C”-shaped configuration of the tibial component 14 .

[0062] Between the two rear extensions 14 ″ there is a recess 14 a. The recess 14 a runs away from the rear portion of the tibial component 14 until approximately the central portion of the tibial component 14 itself.

[0063] At the second surface 19 and at the central portion of the tibial component 14 , a receiving seat 27 (or a further seat 27 ) is located.

[0064] If present, the insert 16 may have a style, shape, and configuration that substantially corresponds to the style, shape, and configuration of the tibial component 14 .

[0065] Furthermore, it may have an opening 16 ′ which, in use, is placed at the housing seat 27 and is thus suitable for housing this housing seat 27 .

[0066] The opening 16 ′ is thus configured in a shape and size that allows the housing 27 to be inserted inside it.

[0067] For example, in Fig. 7A and 7B Details of the shape of at least one rod 22, 24 can be seen in the figure, which has a rod-like configuration.

[0068] At least one rod 22, 24 has an elongated body 28 and a proximal end 25 adapted to be housed inside the housing 23, 27, and in particular inside the cavity 23', 27', during use.

[0069] In at least one version of the invention, the proximal end 25 of at least one rod has a substantially conical, pyramidal or frustoconical shape.

[0070] In at least one version thereof, the proximal end 25 has a blunted tip corresponding to the apex of a cone or pyramid or frustoconical shape and a base having a circular or polygonal cross-section.

[0071] The base of the proximal end 25 is connected (possibly integrally) to a base 25 ′ of an elongated body 28 of at least one rod.

[0072] At least one rod 22 , 24 also has a further end 29 or distal end 29 opposite the proximal end 25 .

[0073] The shape of the cavity 23 ′, 27 ′ adapted to receive the proximal end 25 is adapted to allow tilting and / or rotation of the proximal end 25 and therefore of the at least one rod 22 , 23 about an insertion axis X of the proximal end 25 into the cavity 23 ′, 27 ′.

[0074] By tilting the rods 22, 24 in at least both the frontal and sagittal planes, the degree of inclination can be adjusted.

[0075] In one version of the invention, the walls 23'', 27'' are substantially parallel to the insertion axis X of at least one rod 22, 24 inside at least one seat 23, 27. Additionally or alternatively, the walls 23'', 27'' may be substantially perpendicular to the central portion of the femoral component 12 itself and / or its first surface 13 and / or the first surface 17 of the tibial component 14.

[0076] In another version, the walls 23 ″, 27 ″ are not perpendicular to these surfaces but are inclined relative to them.

[0077] Likewise, the medial surface of at least one cavity 23', 27' may be perpendicular or inclined relative to such surface, and the inner base wall of at least one cavity 23', 27' may be perpendicular to or inclined relative to the insertion axis X. If such inner base wall is inclined, it may follow the direction of the first surface 13, 17 of the femoral component 12 and / or the tibial component 14, respectively.

[0078] According to one version, the configuration of the cavities 23 ′, 27 ′ is substantially cylindrical so as to house the conical proximal end 25 or another of the shapes mentioned.

[0079] More generally, the shape of the cavity 23', 27' is conical, cylindrical, pyramidal, truncated conical, or in any case suitable for loosely accommodating at least one rod 22, 24 and thus allowing at least one rod 22, 24 to be tilted or rotated relative to the insertion axis X of the proximal end 25 into the housing 23, 27.

[0080] In these cases, the widest part of the cavity 23 ′, 27 ′ is furthest from the first surface 13 , 17 on which the at least one housing seat 23 , 27 is located, so as to form a gap or opening for the insertion of the proximal end 25 .

[0081] There is thus a loose coupling between the at least one housing seat 23 , 27 and the at least one rod 22 , 24 , so as to allow tilting and / or rotation of the at least one rod 22 , 24 within the housing seat 23 , 27 relative to the insertion axis of the at least one rod 22 , 24 itself.

[0082] To achieve this, as described above, the receiving seats 23, 27 may also have a shape similar to or the same as the proximal end 25, but define a larger space than the proximal end 25 to allow the rods 22, 24 to tilt relative thereto.

[0083] In more detail, at least in one version of the invention, the depth of the cavity 23 ′, 27 ′ and / or of the housing 23 , 27 substantially corresponds to and / or is slightly greater than the length of the proximal end 25 of at least one rod 22 , 24 .

[0084] Furthermore, the gap or opening of at least one cavity 23', 27' is substantially larger than the diameter or cross-section of the proximal end 25 (in order to allow its insertion). Thus, there is a free space between the inner wall of the cavity 23', 27' and the proximal end 25, which precisely allows the tilting and / or rotation of at least one rod 22, 24.

[0085] However, in at least one version of the invention, the gap or opening of at least one cavity 23', 27' may be sized slightly smaller than the base 25' to allow the base 25' to rest on the peripheral top edge of the wall 23", 27".

[0086] The peripheral top edge of the wall 23 ″, 27 ″ is intended to be an upper edge facing away from the first surface 13 and / or the first surface 17 of the femoral component 12 and / or the tibial component 14 , respectively.

[0087] The base 25' can be substantially flat or slightly inclined and / or tapered relative to the proximal end 25 (eg, Figure 6 ).

[0088] The elongated body 28 extends along an axis of symmetry or longitudinal axis Y between a proximal end 25 and a distal end 29 .

[0089] According to one version, at least one housing 23 , 27 can have a sleeve configuration.

[0090] It is understood that if surgical requirements do not require the presence of rods 22, 24, the spacer device 10 according to the present invention may be implanted identically without any limitation.

[0091] Elongated body 28 has a rod-like configuration that, at least in one version of the invention, has a tapering configuration relative to proximal end 25 toward distal end 29 .

[0092] At least one of the rods 22, 24 according to the invention is a diaphyseal rod, i.e., it is inserted into the diaphyseal of the femur and / or tibia of the patient. The presence of a rod 22 for the femoral component 12 and / or a rod 24 for the tibial component 14, or the presence or absence of both, varies depending on the surgical needs and the physician's choice. This aspect also depends on the type of prosthesis that is removed before the implantation of the spacer device 10, since the prosthesis may be equipped with one or more of these rods, and therefore, in order to better treat any infection, it is advisable to insert a rod where the original prosthesis that was subsequently infected included a corresponding rod.

[0093] The elongate body 28 has a substantially circular or polygonal cross-section (transverse to its elongate shape).

[0094] If the cross section of the elongated cylinder 28 is polygonal, there may be, for example, a first longitudinal face and a second longitudinal face substantially parallel to each other. In this version, these faces may be positioned laterally and medially or anteriorly and posteriorly relative to the human body or bone into which at least one rod 22, 24 must be inserted.

[0095] Alternatively, where the elongated body cross-section 28 is circular, the outer wall of at least one of the rods 22, 24 has a circular surface.

[0096] In at least one version of the invention, elongated body 28 and / or at least one of its first and second faces may include at least one recess 30 .

[0097] This at least one recess 30 has a substantially longitudinal and / or parallel path relative to the axis Y of at least one rod 22 , 24 .

[0098] Furthermore, the depth of the at least one recess 30 (ie the portion inside the elongated body 28 ) is much smaller relative to its extension in a plane and / or its longitudinal length and / or direction parallel to the axis Y of the at least one rod 22 , 24 .

[0099] Likewise, the at least one recess has a substantially rectangular or trapezoidal shape with rounded corners, wherein the short sides are at the proximal end 25 and / or the distal end 29 and the long sides are parallel to the axis Y of the at least one rod 22 , 24 .

[0100] Thus, the length of at least one recess 30 is greater than its width and much greater than its depth.

[0101] exist Fig. 7A and 7B In the embodiment shown by way of example in FIG. 2 , the rods 22 , 24 have three recesses on each side or face, which are arranged one after the other and aligned along the axis Y of at least one of the rods.

[0102] Interspersed between these recesses are intermediate ribs 31 , each of which extends towards the outside of the rods 22 , 24 , flush with or extending beyond the outer surface of the elongated body 28 .

[0103] Such ribs 31 may be parallel and similar to the base 25 ′.

[0104] In at least one version, for example, when the cross-section of the elongated body 28 is generally circular, the at least one recess 30 may be radially disposed relative to the axis Y of the rods 22, 24. Alternatively, the at least one recess 30 may have an annular band pattern that extends concavely toward the interior of the rods 22, 24 as a kind of concave band relative to the rods 22, 24 themselves, with its center on the axis Y.

[0105] In this case too, the depth of at least one recess 30 is smaller than its length and circular extension.

[0106] Of course, with respect to the number of recesses 30 shown, depending on the length of the rods 22 , 24 and as required, there may be one or more recesses and therefore one or more ribs 31 .

[0107] In practice, the rods 22, 24 may have a length between 5 cm and 30 cm, depending on the anatomy of the patient.

[0108] As long as the rods 22, 24 can be inserted into suitable housings 23, 27, the invention has the advantage that the rods themselves are interchangeable and the doctor can choose the rod that best suits his needs, choosing its length, the size and number of recesses 30 present therein (if any).

[0109] In at least one version of the present invention, at least one filler material 32 may be present within at least one recess 30 .

[0110] In one version of the invention, filler material 32 comprises acrylic bone cement, such as polymethylmethacrylate or PMMA, or another suitable material.

[0111] In other forms of the invention, filler material 32 may include any solid, fluid and / or viscous filler material suitable for delivering at least one drug or medical substance and slowly releasing such at least one drug or medical substance over time to obtain a prolonged and lasting pharmacological effect.

[0112] The filler material 32 includes at least one drug or medical substance, such as at least one antibiotic.

[0113] In one form of the invention, in each recess 30, the filling material 32 contains different drugs or medical substances, for example, substances a and / or b and / or c (such as Figure 7B ).

[0114] The shape of the recess 30 allows the physician to quickly fill it prior to implanting the rods 22, 24 and spacer device 10, depending on the patient's specific needs.

[0115] In this embodiment, the physician can fill the at least one recess 30 in an orderly manner, that is to say without exceeding the peripheral edge of the recess 30 itself and / or of the rib 31. Such an edge and / or rib is easily visually visible to the physician.

[0116] In this manner, the filler material 32 will lie flush relative to the outer surface of the elongated body 28 of at least one of the rods 22 , 24 .

[0117] In another form combined with or replacing the above-mentioned form, a different filling material 32 can be placed in each recess 30, and the filling material 32 can be mixed with the same drug or medical substance or with at least one of different drugs or medical substances a, b, c in each recess 30.

[0118] Regarding the method of assembling at least one rod 22, 24, after having provided the femoral component 12 and / or the tibial component 14 each provided with at least one corresponding receiving seat 23, 27, the cavity 23', 27' of at least one receiving seat 23, 27 is filled with fresh and / or fluid bone cement (such as acrylic or polymethylmethacrylate bone cement).

[0119] In this cavity 23 ′, 27 ′, the proximal end 25 of at least one rod 22 , 24 is accommodated or inserted.

[0120] This end 25 is inserted or housed along a direction corresponding to the axis X of insertion thereof.

[0121] Thus, the proximal end 25 is inserted into the bone cement.

[0122] Then, in use, the spacer device 10 of the joint seat in question is implanted and at least one stem 22, 24 is inserted into the diaphyseal canal of the femur and / or tibia, respectively.

[0123] Since the rods 22, 24 are adapted to be tilted and / or rotated relative to the insertion axis in the housing 23, 27, it is possible to orient the rod itself in a specific direction of the diaphysis of interest, thus allowing the inclination of the medullary canal to be followed smoothly. The mobility of at least one rod 22, 24 is allowed by the fact that, at this time, the bone cement present in the housing 23, 27 is still in a fluid state.

[0124] After the at least one rod 22, 24 has been properly oriented and implantation of the spacer device 10 is complete, over a period of several minutes the bone cement will become solid, polymerize, locking the at least one rod 22, 24 in place.

[0125] In a preferred but non-limiting embodiment of the present invention, the spacer device 10 includes both a stem 22 for the femoral component 12 and a stem 24 for the tibial component 14 .

[0126] At least one of the rods 22, 24 may include an inner core 28', possibly made of a metallic material, in order to give the rod itself greater rigidity and strength.

[0127] The core 28' may be internal to the elongated body 28 and have a substantially rod-like configuration, possibly with a cylindrical cross-section.

[0128] Finally, it is possible to provide at least one of the femoral component 12, tibial component 14, insert 16, and at least one stem 22, 24 in a variety of sizes (eg, small, medium, and / or large) to better accommodate the anatomical needs of a patient.

[0129] These measurements or dimensions can be used in conjunction with all dimensions of the other components to provide the physician with greater variability and choice.

[0130] To this end, the inclination of the contact surfaces between the femoral component 12, the tibial component 14 and the insert 16 remains substantially constant as the dimensions vary, thereby allowing them to be assembled in any case.

[0131] Similarly, the position and / or dimensions of at least one seat 23, 27 of the opening 16' (when the insert 16 is present) and the dimensions of the proximal end 25 will be substantially constant as the dimensions of the components and / or rods vary, allowing them to be assembled anyway.

[0132] Therefore, the present invention also comprises a kit for constructing and / or assembling a spacer device 10 according to the present invention.

[0133] Each element or component of the spacer device 10 is made of a biocompatible material, such as acrylic bone cement, optionally based on or including polymethylmethacrylate (PMMA).

[0134] According to one version of the invention, the biocompatible material may include a plastic material that may be thermoformable, such as polyvinyl chloride (PVC), polystyrene (PS), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), high or low density polyethylene, etc., or may include non-polymeric materials, ceramic materials, metals, metal alloys, organometallic compounds, etc. and / or combinations thereof.

[0135] The biocompatible material may be porous and / or provided with interconnected pores and / or canaliculi and thus suitable for absorbing and subsequently releasing a drug or medical substance supplied in the form of an aqueous solution or fluid.

[0136] Similarly, the filling material 32 may be porous and / or provided with interconnected pores and / or tubules and thus adapted to absorb and subsequently release drugs or medical substances a, b, c supplied in the form of an aqueous solution or fluid.

[0137] The fill material 32 may be a solid or a curable fluid.

[0138] In one version of the invention, at least one rod 22 , 24 may have been provided with a filler material 32 within at least one recess 30 .

[0139] Thus, it has been seen that the present invention can be adapted to the specific surgical and anatomical needs of a patient, providing a spacer device 10 having at least one rod 22, 24 adapted to be oriented (tilted and / or rotated) according to its specific orientation in the diaphyseal canal into which it must be inserted by the user.

[0140] The spacer device 10 according to the invention is susceptible of numerous modifications and variations within the scope of the following claims.

Claims

1. A temporary spacer device (10) for a human joint, the spacer device comprising: a first component adapted, in use, to be constrained to a patient's bone at said human joint; a second component, which is suitable for being constrained to the patient's bone at the human joint during use; and at least one rod, which is provided with a proximal end (25), wherein the at least one rod has a rod-like structure, a longitudinal axis (Y), and includes a slender body (28), which extends from the proximal end (25) along the longitudinal axis (Y) to a distal end (29) opposite to the proximal end (25), wherein the first component and / or the second component includes at least one receiving seat for the proximal end (25) of the at least one rod, which is suitable for allowing the at least one rod to be tilted and rotated relative to the insertion axis (X) of the proximal end (25) in the at least one receiving seat, and wherein Characterized in that the elongated body (28) comprises at least one recess (30) which accommodates a filling material (32) and at least one drug or medical substance, wherein the at least one recess (30) has a substantially rectangular or trapezoidal shape with rounded corners and is interspersed with intermediate ribs (31), each rib extending towards the outside of the rod, reaching flush with the outer surface of the elongated body (28), wherein the filling material (32) is placed flush with the outer surface of the elongated body (28) of the at least one rod, wherein the depth of the at least one recess (30) is much smaller than its extension in a plane and its longitudinal length parallel to the longitudinal axis (Y) of the at least one rod.

2. The spacer device according to claim 1, characterized in that The human body is a knee joint, the first component is a femoral component (12) adapted to be constrained to the patient's femur at the knee joint in use, and the second component is a tibial component (14) adapted to be constrained to the patient's tibia at the knee joint in use.

3. The spacer device according to claim 1, characterized in that The at least one rod includes a first rod placed at the first component and / or a second rod placed at the second component, or vice versa.

4. The spacer device according to claim 1, characterized in that The first component has a generally "C"-shaped configuration in a plan view viewed from above and / or has a generally "U"-shaped side configuration, and / or the first component includes a first surface (13) adapted to face and / or be constrained to a bone during use and a second surface (15) adapted to face the second component during use, wherein the first surface (13) of the first component has a generally "U"-like concave shape and the second surface (15) of the first component has a generally "U"-like convex shape.

5. The spacer device according to claim 1, characterized in that The second component has a generally "C"-shaped configuration in a plan view viewed from above, and / or comprises a first surface (17) adapted to face and / or be constrained to a bone during use and a second surface (19) adapted to face the first component during use, and / or comprises an insert (16) having an opening (16') for accommodating a second accommodating seat (27) and / or the rod, wherein the insert (16) is adapted to be inserted between the first surface (17) of the second component and the patient's bone during use.

6. The device according to claim 1, characterized in that The at least one receiving seat comprises a first receiving seat placed at the first surface (13) of the first component and / or a second receiving seat (27) located at the first surface (17) of the second component, wherein the at least one receiving seat comprises at least one cavity for receiving the proximal end (25) of the at least one rod.

7. The device according to claim 6, characterized in that The receiving seat comprises a receiving wall, wherein the receiving wall defines a cavity and moves away from the first surface (13) of the first component so as to move away from the latter and / or extend towards the patient's bone, and / or wherein the receiving seat comprises a receiving wall, wherein the receiving wall defines the cavity and moves away from the first surface (17) of the second component so as to move away from the latter and / or extend towards the patient's bone.

8. The spacer device according to claim 1, characterized in that The proximal end (25) has a substantially conical, pyramidal or frustoconical configuration.

9. The spacer device according to claim 7, characterized in that The at least one cavity has a cylindrical, conical, pyramidal, truncated conical or truncated pyramidal configuration and / or a structure suitable for accommodating the proximal end (25) in a relaxed or loose manner, and / or wherein the at least one cavity has a gap or opening for insertion of the proximal end (25).

10. The spacer device according to claim 7, characterized in that The receiving wall is substantially parallel to the insertion axis (X) and / or substantially perpendicular to the first surface (13) of the first component and / or the first surface (17) of the second component, or substantially inclined relative to the insertion axis (X) or the first surface (13) of the first component or the first surface (17) of the second component.

11. The spacer device according to claim 1, characterized in that The depth of the at least one cavity substantially corresponds to and / or is slightly greater than the length of the proximal end (25) of the at least one rod.

12. The spacer device according to claim 9, characterized in that The size of the gap or opening is substantially larger than the diameter or cross-section of the proximal end (25), but slightly smaller than the size of the base (25') of the elongated body (28) of at least one rod, wherein the base (25') is connected to the proximal end (25).

13. The spacer device according to claim 12, characterized in that The containment wall has a peripheral upper edge supporting a base (25') of the at least one rod.

14. The spacer device according to claim 1, characterized in that The slender body (28) is arranged to be tapered toward the distal end (29), and / or has a substantially circular or polygonal cross section intersecting the longitudinal axis (Y), wherein the slender body (28) comprises a circular outer wall or a first longitudinal surface and a second longitudinal surface that are substantially parallel to each other.

15. The spacer device according to claim 1, characterized in that The outer circular wall of the slender body (28) and / or at least one of its first and second faces include at least one recess (30), which is suitable for containing a filling material (32), or wherein the outer circular wall of the slender body (28) and / or at least one of its first and second faces include the at least one recess (30) and the filling material (32) contained in the at least one recess (30).

16. The spacer device according to claim 1, characterized in that The at least one recess (30) has a substantially longitudinal and / or parallel path relative to the longitudinal axis (Y) of the at least one rod.

17. The spacer device according to claim 1, characterized in that The short sides are located at the proximal end (25) and / or the distal end (29), while the long sides are parallel to the longitudinal axis (Y) of the at least one rod or have the configuration of an annular band.

18. The spacer device according to claim 1, characterized in that The at least one recess (30) alternates with the following at least one recess (30) starting from at least one intermediate rib (31), wherein the at least one intermediate rib (31) is parallel to the base (25') of the rod.

19. The spacer device according to claim 13, characterized in that The filling material (32) comprises acrylic bone cement, or another suitable material adapted to deliver and / or release at least one drug or medical substance.

20. The spacer device according to claim 19, characterized in that The filling material (32) is polymethyl methacrylate.

21. The spacer device according to claim 19, characterized in that The filling material (32) is a solid and / or fluid filling material.

22. The spacer device according to claim 19, characterized in that The filling material (32) is a viscous filling material.

23. The spacer device according to claim 19, characterized in that The at least one drug or medical substance is at least one antibiotic.

24. The spacer device according to claim 1, characterized in that The at least one rod comprises an inner core (28') having a generally rod-like configuration.

25. The spacer device according to claim 24, characterized in that The inner core is made of metal material.

26. The spacer device according to claim 1, characterized in that The spacer device (10) and / or the at least one rod are preformed and made of a biocompatible material.

27. The spacer device according to claim 26, characterized in that The biocompatible material is acrylic bone cement.

28. The spacer device according to claim 26, characterized in that The biocompatible material is porous.

29. The spacer device according to claim 26, characterized in that The biocompatible material is provided with interconnected pores.

30. The spacer device according to claim 26, characterized in that The biocompatible material is provided with small tubes.

31. The spacer device according to claim 26, characterized in that The biocompatible material is based on or comprises polymethyl methacrylate.

32. The spacer device according to claim 1, characterized in that The spacer device (10) and / or the at least one rod are preformed and manufactured from a plastic material.

33. The spacer device according to claim 32, characterized in that The plastic material is thermoformable.

34. The spacer device according to claim 32, characterized in that The plastic material is polyvinyl chloride, polystyrene or polyethylene.

35. The spacer device according to claim 32, characterized in that The plastic material is ultra-high molecular weight polyethylene, high density polyethylene or low density polyethylene.

36. The spacer device according to claim 1, characterized in that The spacer device (10) or the at least one rod is preformed and made from a non-polymeric material.

37. The spacer device according to claim 1, characterized in that The spacer device (10) or the at least one rod is preformed and manufactured from a ceramic material.

38. The spacer device according to claim 1, characterized in that The spacer device (10) or the at least one rod is preformed and manufactured from metal.

39. The spacer device according to claim 1, characterized in that The spacer device (10) or the at least one rod is preformed and manufactured from a metal alloy.

40. The spacer device according to claim 1, characterized in that The spacer device (10) or the at least one rod is preformed and made from an organometallic compound.

41. A kit for realizing a spacer device (10) according to any of the preceding claims, comprising at least one first component, at least one second component, provided with at least one receiving seat, at least one insert (16) and at least one rod, wherein: The at least one rod has a rod-like configuration, a longitudinal axis (Y) and comprises an elongated body (28) extending from the proximal end (25) along the longitudinal axis (Y) to a distal end (29) opposite the proximal end (25), wherein the at least one first component, the at least one second component, the at least one insert (16) and the at least one rod each have different dimensions, characterized in that the elongated body (28) comprises at least one recess (30) which accommodates a filling material (32) and at least one drug or medical substance, wherein the at least one recess (30) has a substantially rectangular or trapezoidal shape with rounded corners and is interspersed with intermediate ribs (31), each rib extending towards the outside of the rod flush with the outer surface of the elongated body (28), wherein the filling material (32) is placed flush with the outer surface of the elongated body (28) of the at least one rod, wherein the depth of the at least one recess (30) is much smaller than its extension in a plane and its longitudinal length parallel to the longitudinal axis (Y) of the at least one rod.

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