KR102687742B1 - Prosthetic device for the human body and method for its production - Google Patents

Abstract

The prosthetic device (1, 100, 200, 300) is configured to prevent and/or treat infections that occur and/or may occur in bone or joint areas and is configured to be implanted in the human body, the prosthetic device having a prosthetic body ( 2, 102, 202, 302), which is provided with at least one surface that engages a bone or joint area during use, and at least one cavity (4, 104, 204, 304) disposed along the engagement surface. Provided is that the at least one cavity is configured to contain, be equipped with, or receive at least one pharmaceutical or medical substance 4'.

Description

Prosthetic device for the human body and method of manufacturing the prosthetic device {PROSTHETIC DEVICE FOR THE HUMAN BODY AND METHOD FOR ITS PRODUCTION}

The present invention provides a device that can be permanently implanted in a patient's bones or joints for the treatment and/or prevention of infections that have occurred or may occur in the bones or joints of the human body, and to treat bone damage or fractures. It is about prosthetic devices.

In addition, the present invention provides a prosthesis that can be implanted into a patient's bone or joint area for the prevention and/or treatment of infection that has occurred or may occur in the bone or joint area of the human body and for treating bone damage or fracture. It relates to a method of manufacturing a device.

Currently, it is known that after implanting a prosthesis inside the human body, post-operative infections can occur; The prosthesis can actually be reached by bacteria present at the implantation site or in the surgical environment, which can multiply on the surface of the prosthesis and cause the prosthesis to detach from the bone or joint area.

In such cases, the steps that must follow to combat such infection are removal of the infected prosthesis from the implantation site, implantation of a spacer capable of draining antibiotics or loaded with antibiotics, and finally, once the infection has been completely eradicated. Installing a new prosthesis.

The use of a spacer device is necessary to maintain a substantially unchanged shape of the bone or joint area into which the new prosthesis is to be implanted, and also to combat ongoing infections thanks to the release of antibiotics.

This procedure is a re-prosthetization procedure, known as a "two stage" or "two-stage" procedure, because healing from the infection and implantation of a new prosthesis requires two implantation/treatment stages. am.

The use of a spacer during a “two-stage” or “two-stage” procedure is related to the presence of several bony requirements, such as the ligament being substantially integral in such a way that the spacer is stabilized once implanted, and the implantation of the spacer device. and the need for a joint in which the corresponding bony portion is not excessively excised in such a way that the new prosthesis can be held in a correct and stable position after the stage of removal.

There are also "one-stage" surgical procedures that provide for removal of the infected prosthesis and its replacement with a new prosthesis in a single surgical operation. Nevertheless, such techniques take prior identification of pathogens to employ cement mixed with specific antibiotics with the aim of combating the identified pathogens for re-implantation of the prosthesis.

Such "one-stage" procedures are rapid and, for this reason, less physically and psychologically stressful for the patient, but are noted to have low virulence infections, since new infections only start in a small, though small, 1 percent of cases. . Such reinfection is instead less common in the case of “two-stage” surgical procedures.

US patent US5549699 describes a prosthetic acetabular cup provided with a depression filled with ground bone tissue, which corrects bone loss in the supporting bone and thus causes migration of the acetabular cup itself. This is to prevent. The patent also describes a femoral stem of a hip prosthesis provided with grooves in which ground bone tissue is compressed to have an improved interface surface between the prosthesis and the bone.

US patent US 6245111 discloses a temporary spacer device, which cannot support the weight of the implanted patient. Such a device is formed by the use of a suitable mold, for example with bone cement loaded with antibiotics, to treat infections developing at the implantation site.

Patent application US 2010/0042214 discloses an orthopedic implant, and in particular a temporary implant, provided with a tank and a channel, capable of delivering at least one therapeutic agent contained in said tank towards the patient's tissues. The therapeutic agent is inserted into the tank before and/or after implantation.

US patent application US 2007/0016163 discloses a device adapted to be inserted into a hollow space or canal of bone tissue, which is provided with a number of tanks, for example micro tanks, which contain growth promoters, vascular It includes drugs selected from formation accelerators, analgesics, and combinations thereof.

Such a device may be a single structure, for example cylindrical, or it may be in the form of multiple units, for example a number of balls. Bone prosthetics may also be part of these devices.

Accordingly, to prevent the onset of infection and/or treat existing infections, thus preventing the need to perform subsequent implantation, such as a “stage 1” or “stage 2” type of re-prosthetization surgery, the surgeon sees a need for a permanent type of prosthetic device for initial implantation and correction, which is provided with antibacterial properties or which usually contains pharmaceutical or medical substances.

The object of the present invention is to improve the prior art.

Within the scope of the technical problem of the present invention, one object of the present invention is to provide a prosthetic device capable of treating and/or preventing infections that have occurred or may occur in bone or joint areas of the human body.

Another object of the present invention is to provide a prosthetic device that releases at least one pharmaceutical or medical substance over a long period of time from specific parts of the bone or joint area of the human body to which the prosthetic device relates.

Another object of the invention is to provide a prosthetic device that can be intended for first implantation or revision.

Another object of the present invention is to provide a first-implant antibiotic-loaded prosthetic device that significantly reduces the risk of post-surgical infection of the bone or joint area, and is therefore “stage 1” or “stage 1”. A “two-stage” surgical procedure avoids the need for re-prosthetixation.

According to another aspect of the present invention, a prosthetic device of claim 1 is provided.

According to another aspect of the invention, a method for manufacturing the prosthetic device of claim 14 is provided.

The dependent claims relate to preferred and advantageous embodiments of the invention.

Other features and embodiments of the invention will become apparent from the detailed description of a preferred but non-limiting embodiment of a prosthetic device, shown by way of non-limiting example in the accompanying drawings.
1 is a plan perspective view of an example of a prosthetic device according to the present invention.
Figure 2 is a bottom perspective view of the lower portion of the prosthetic device of Figure 1;
Figure 3 is a bottom perspective view of another embodiment of the lower portion of the prosthetic device of Figure 1;
Figure 4 is a top perspective view of another embodiment of a prosthetic device according to the present invention. Figure 5 is a top perspective view of the acetabular portion or example of a prosthetic device according to the present invention.
Figure 6 is a cutaway perspective view of the acetabular portion or example of the prosthetic device for Figure 5;
Figure 7 is a perspective view of another embodiment of a prosthetic device according to the present invention.
Figure 8 is a perspective view of the prosthetic device of Figure 7 viewed from a different angle;

The prosthetic device according to the invention can be used as a first implant prosthesis and as a revision prosthesis. Such prosthetic devices are of the permanent type.

The term “corrective prosthesis” is intended to indicate that a prosthetic device can be inserted after explants of an infected prosthetic device, i.e., in a “one-stage” surgical procedure, or as a spacer in a “two-stage” procedure. is inserted after removal. For example, despite sanitization of the area due to the spacer, the patient is still left at risk of reinfection, leading to the widespread use of final prosthetics provided with drugs or medical substances according to the invention or loaded with antibiotics. Such cases may arise when the doctor thinks about what to decide to do.

The prosthetic device according to the present invention is in fact a final prosthesis. In that sense, the prosthetic device can remain in the human body without limitations and can only be removed from the human body under exceptional circumstances (such as accidental destruction or other causes linked to the patient's health).

More specifically, the prosthetic device performs the functions of a standard prosthesis, but may additionally prevent the onset of infection following surgery in bone or joint areas and/or allow treatment of such areas if infection is already in progress.

The prophylactic or therapeutic action is effected due to the release of at least one pharmaceutical or medical substance by the prosthetic device in the implantation area or the infection area.

The prosthetic device according to the invention allows the release of said at least one pharmaceutical or medical substance, for example in trace amounts, over an extended period of time; In this way, the bone or joint area where implantation of the device itself occurred or the area to be treated can absorb all particles of the at least one pharmaceutical or medical substance released daily by the device, thus providing improved protection against infection. and/or obtain treatment. In that way, the risk of starting the infection is substantially limited.

The configuration of the prosthetic device to be described below allows the release of at least one pharmaceutical or medical substance, possibly in trace amounts, into contact with or immediately adjacent to the bone or joint area to be treated or implanted. By doing so, the absorption process of such substances is efficient.

Additionally, the configuration of the prosthetic device according to the invention is adapted to be substantially complementary to the shape of the bone or joint area to be implanted or treated.

In the accompanying drawings, several possible configurations of the prosthetic device according to the invention are shown by way of example and not by way of limitation: in particular, the prosthetic device can be used in the tibial portion of the knee prosthesis (shown in Figures 1 to 3); The femoral portion of a knee prosthesis (shown in Figure 4), the acetabular portion of a hip or shoulder prosthesis (shown in Figures 5 and 6), and the stem portion of a hip or shoulder prosthesis (shown in Figures 7 and 6). shown in FIG. 8) or a general bone prosthesis.

The prosthetic device according to the invention is made of materials that are biologically compatible with human tissue. For example, such materials may be metals, metal alloys, organo-metallic compounds, ceramics, or combinations thereof.

In one embodiment of the invention, biologically compatible materials include acrylic resins, plastic materials, ceramic materials, high porosity resins, bone cement or polymethyl methacrylate (PMMA), thermoplastic polymers, polyethylene, polyester. It may include or be at least partially encompassed by propylene, polyester, thermoforming polymer or combinations thereof or other similar materials.

The coating may cover only a portion of the prosthetic device in one example of the invention, most of which is typically in direct contact with or subject to rubbing with the patient's bone tissue.

Additionally, most parts that experience wear can have a coating that imparts great hardness; Such coatings can be obtained by application or deposition of at least one metal oxide and/or nitride, for example titanium nitride.

However, in an alternative example of the invention, the coating may cover the entire surface of a prosthetic device configured to be placed in contact with a patient's bone tissue during use.

Since such a configuration of the prosthetic device according to the invention is substantially complementary to the shape of the bone or joint area to be implanted or treated, for example by filler material 4', as will be explained in more detail later. The formed, possibly coating, will have a predetermined thickness, for example a uniform thickness, and will cover substantially the entire surface of the prosthetic device in contact with the bone tissue. In that way, the coating will cover the surface with a shape corresponding to the shape of the bone or joint area to be treated, and thus the coating will have, in its thickness, a shape corresponding to the shape of the bone or joint area to be treated. will have

Notwithstanding the above, to fabricate the prosthetic device according to the invention, other biocompatible types of materials may be used in relation to those described above, without departing from the scope of protection of the invention.

1 to 3, a prosthetic device according to the present invention includes a prosthetic tibial element for a knee joint, generally indicated by reference numeral 1.

The prosthetic device (1) includes at least one prosthetic body (2).

The prosthetic body 2 has a shape substantially complementary to the shape of the bone or joint area on which it is to be implanted or, in any case, to be treated.

In particular, the prosthetic body 2 comprises a tibial plate component and possibly a stem component (S).

Considering a section along the transverse plane of the body, the stem S has a substantially tubular shape, while the tibial plate element 20 is substantially flat and has a “C” shape.

In that way, the positioning of the prosthetic device 1 in the bone or joint area is accurate and the performance obtained is optimal.

The prosthetic device 1 is configured to be limited to the tibial end of the knee joint. In detail, the stem (S) is configured to be inserted into the tibial medullary space at the knee joint.

The stem (S) is hollow and has a cavity (H) on the inside; The stem S comprises a hole F through the wall of the stem S itself, towards the implantation site of the prosthetic device 1 or towards the area or bone tissue to be treated, into the cavity H. It is configured to deliver at least one pharmaceutical or medical substance contained in the included filler material 4' or in the cavity H of the stem S.

Such pharmaceutical or medical substances can be inserted into the interior of the stem (S) by means of an opening (A) disposed in the stem itself, which is larger than the size of the holes (F). Such an opening A is arranged in particular at the distal end S1 of the stem S, which is adapted to be inserted into the tibial medullary space at the knee joint during use. The prosthetic body (2) is provided with at least one engagement surface (3) adapted to come into contact with the bone or joint area to be treated.

The opening (A) is arranged continuously with the cavity (H) of the stem (S).

The configuration of the engagement surface 3 is substantially complementary to the bone or joint area of the patient, so that positioning and connecting the prosthetic device 1 in/to the bone or joint area is accurate.

Moreover, in one example, the engagement device 3 is in full contact with bone tissue during use.

The engagement surface 3 is shaped in such a way as to allow engagement of the prosthetic body 2 to the tibial end at the knee joint, as shown in FIGS. 1 to 3 . The prosthetic body (2), in particular the engagement surface (3), has at least one cavity (4).

According to one example of the invention, the cavity 4 is a groove or slot.

According to one embodiment of the invention, the at least one cavity has a substantially polyhedral or parallelepiped shape, for example a parallelepiped or a cube with a rectangular base or a right angled parallelepiped, with only one face of such shape. It is defined by an opening as described in detail below.

In one example of the invention, at least one cavity (4) has a planar or lateral dimension that is greater than the depth inside the prosthetic device (1).

According to one example of the invention, at least one cavity 4 comprises, contains or is configured to receive filler material 4'.

According to another example of the invention, the bonding surface 3 is entirely covered with a filler material 4'. In that case, the mating surface 3 comprises a coating of filler material 4', which is disposed in contact with it on the entire mating surface 3 itself.

In one embodiment of the invention, the stem S comprises a coating of filler material 4', which is disposed in contact with it on the entire surface of the stem S itself, which surfaces, when in use, are exposed to the bone tissue of the patient. It is configured to be placed in contact. In one example of the invention, when covering the stem S, the coating of filler material 4' should have a hard and/or compact consistency. To obtain such a coating of filler material 4', for example, porous ceramics, terracotta, plastic materials or materials with hard hardness can be used. Such materials can guarantee a certain strength. In any case, the filler material 4' and/or the coating are porous or contain small channels such that once the prosthetic device 1 is immersed in a medicated solution or a solution containing a pharmaceutical substance or medical substance. It is done in a way that allows it to permeate.

Furthermore, the presence of pores or small channels allows the prosthetic device 1 to release at least one pharmaceutical or medical substance for treatment, prevention or cure in the bone or joint area of the human body. The filler material 4' may be in the form of a coagulable fluid or in the form of a solid.

In one example of the invention, the filler material 4' has a semi-solid form, for example a gel form.

In one example of the invention, filler material 4' is placed in at least one cavity 4 and cured.

Furthermore, the filler material 4' occupies the entire space corresponding to at least one cavity 4 and thus completely fills it.

Alternatively, the filler material 4' occupies the entire engagement surface 3 and is configured to be placed in contact with the patient's bone tissue during use.

The use of filler material 4' ensures at least partially restoration of the mechanical as well as geometric properties of prosthetic devices of the conventional type.

In one example of the invention, the filler material 4' may comprise or be mixed with at least one pharmaceutical or medical substance.

More specifically, the filler material 4' can be mixed with the filler material itself at a surgical stage (also based on the state of infection encountered and the needs of the patient) at least one pharmaceutical or medical substance. It may not initially have pharmaceutical or medical substances.

Alternatively, the filler material 4' may comprise at least one pharmaceutical or medical substance in such a way that it can be inserted into the cavity/cavities 4 without the need to add any substance necessary to treat the infection. (Possibly, for specific needs, the filler material 4' can be mixed with other materials in addition to those already contained therein).

In fact, when the filler material is already positioned in at least one cavity 4 of the prosthetic device according to the invention, at least one pharmaceutical or medical substance, such as an antibiotic, can already be present in the (porous) filler material 4 ′. (e.g. such placement of filler material 4' within at least one cavity of the prosthetic device does not occur in the operating room, but takes place in the workshop during manufacture of the prosthetic device).

For example, into the porous filler material 4', a first antibiotic (such as Gentamicin) can be inserted by the manufacturer, which is absorbed into the filler material 4'. Once the prosthetic device arrives in the operating room, there is nothing preventing the surgeon from deciding to add a second antibiotic (such as Vancomycin) to enhance the antibiotic action, based on the specific patient's needs. This can be achieved by immersing the prosthetic device in a solution containing a second antibiotic or vancomycin or by applying droplets of the same solution to the porous regions of the filler material 4' which retain the ability to absorb other substances. . The results of tests have shown that if a porous material already impregnated with a first antibiotic is immersed in a solution of a second antibiotic, the porous material captures both antibiotics and loses only a minimal part of the first antibiotic. .

Accordingly, the filler material 4' may comprise or be mixed with at least one pharmaceutical or medical substance.

In one example of the present invention, the filler material 4' is a composite material including acrylic resin, polyvinyl alcohol, bioglass, calcium sulphate, inorganic salt, or calcium phosphate. It may contain at least one of the substances or mixtures thereof.

In another example of the invention, the filler material 4' may comprise an absorbent material, for example silk thread, cotton thread or biocompatible plant fiber or for example an antibiotic. It may comprise a nonwoven or fabric capable of absorbing and impregnating at least one pharmaceutical or medical substance.

In another example, the filler material 4' comprises a biocompatible semi-solid material, which comprises a pharmaceutical or medical substance such as an antibiotic.

In this case, the semi-solid material may be insoluble (e.g. bone cement) or soluble (e.g. animal collagen, sugar, cellulose, etc.).

Additionally, the filler material 4' may be porous or contain pores or small channels. Such pores must be of an appropriate size to inhibit bone growth within the material itself.

In one example of the invention, such porosity is configured in a random manner. For example, in fact, such porosity is created inherently during the formation or fabrication of the filler material 4'.

According to another example, the filler material 4' may correspond to the material making up the prosthetic body 2.

In one embodiment of the invention, the filler material 4' is non-biodegradable, insoluble or permanent, while the at least one pharmaceutical or medical substance is soluble or from the filler material 4'. It can be avoided.

The at least one pharmaceutical or medical substance may have a liquid, fluid and/or viscous or solid form.

The filler material 4' has, in substantially its entire volume, a plurality of small channels with dimensions on the order of micrometers (if the dimensions perpendicular to the dimensions of the large extensions of the small channels themselves are taken into account).

Such small channels can absorb and extract liquid through capillaries.

In one possible configuration, small channels are connected together.

Moreover, in one example, the small channels and/or pores may have an average cross-sectional size of approximately 100 microns.

The dimensions of the pores of the absorbent, filler material 4' determine its larger or smaller capillary forces, which determine the absorption of the at least one pharmaceutical or medical substance. In particular, the finer the pores, the greater the capillary action and therefore the greater the amount of antibiotic solution or pharmaceutical or medical substance absorbed.

Therefore, for absorption purposes only, in one example of the invention, pores smaller than 100 microns are ideal, within which bone migration is not significant.

In a preferred embodiment of the invention, the filler material 4' comprises an acrylic resin and an inorganic salt, for example polymethylmethacrylate (PMMA) and calcium phosphate or tri-calcium phosphate (TCP). .

In one example of the invention, the prosthetic device further includes an articular surface. Such joint surfaces are smooth; The articular surface is therefore devoid of cavities and coatings and therefore devoid of filler material 4'.

The prosthetic device according to the invention, in at least one example, is at least partially porous and prevents bone tissue from growing therein, with respect to its porous regions and possibly non-porous regions.

In an alternative example, bone tissue may instead be allowed to grow or migrate within the material that makes up the prosthetic device itself and within the pores of the filler material 4'.

Since this is a permanent prosthesis in nature, migration of the bone within the pore can be positive and therefore desirable, since it improves the durability of the implant by contributing to the stabilization of the prosthesis.

In other examples, bone growth or migration is allowed within the pores of the material making up the prosthetic device and is not allowed within the filler material 4', or, conversely, is allowed within the pores of the filler material 4' and causes the prosthesis itself. It is not permitted within the pores of the constituent materials.

In one possible configuration, as shown in FIGS. 1 to 3 , the prosthetic device has a plurality of cavities 4 arranged along an engagement surface 3 .

According to a non-limiting example, the depths of the cavities 4 within the prosthetic body 2 may vary relative to each other in the same device 1 .

Moreover, the positioning, number and shape of cavities 4 can be varied as a function of specific requirements.

The size of the cavities 4 may in any case vary as a function of the size of the prosthetic body 2 .

Each cavity (4) defines a corresponding opening (5) extending through the mating surface (3).

In one embodiment, as shown in Figure 3, some of the cavities 4 may have elements C, which are configured to enable identification of the correct positioning of the prosthetic device 1 in the bone or joint region. do. In such cases, there may be, for example, an interaction with a template or collimation mask of the instrument specified for the prosthesis in question.

As already mentioned above, at least one cavity 4 acts as a housing for the filler material 4'. In fact, within at least one opening 5 or within only some of the openings 5 and/or within at least one cavity 4 or within only some of the cavities 4, if a plurality of cavities are present within the prosthetic body 2 ( 4), if any, contains or contains a filler substance 4', which may comprise at least one pharmaceutical or medical substance that is released into the patient's body.

In one possible example of the invention, prior to implantation of the prosthetic device itself, i.e. during the surgical procedure, the surgeon prepares the filler material 4' and places it within the cavity/cavities 4.

Nevertheless, if the surgeon realizes prior to implantation that the situation has changed with respect to the previously established situation, he may decide not to add filler material 4' to the prosthetic device 1, since the prosthetic device This is because it ensures mechanical support properties, which are characteristics of permanent prosthetics. Accordingly, the present invention provides the other advantage of being able to verify only at the time of transplantation when the doctor directly inspects the condition of the tissue at the transplant site after surgical opening and thus the actual needs of the patient.

The prosthetic device 1 has a configuration, as described, to ensure that the filler material 4' is in contact with the joint tissue or bone to be treated or implanted; As a result, such filler material 4 ′ fills the cavity 4 such that it protrudes in relation to the engagement surface 3 or is flush with the engagement surface 3 . In that way, a surface that is continuous with the mating surface 3 of the prosthetic body 2 is obtained.

Depending on the time period assessed to be necessary to deliver the at least one pharmaceutical or medical substance to the joint or bone area of the implant, the total volume occupied by the at least one cavity 4 can be varied, so that the prosthetic device 1 ) can ensure the release of at least one pharmaceutical or medical substance during the entire selected period.

In another example of the invention, the prosthetic device (1) comprises a cavity (4) in the engagement surface (3) whose size substantially corresponds to the size of the engagement surface (3) itself; Such cavities 4 are filled with filler material 4'. The configuration of the cavities 4 can be such that an open cell structure 6 is formed along the bonding surface 3 .

The open cell structure 6 includes a plurality of cells arranged right next to each other, each of which corresponds to a cavity 4 .

The open cells 6 or cavities 4 are separated from each other by ribs 7.

Such ribs 7 represent intervening walls between the cavities 4 themselves or between the cells 6 themselves, which allow the physical separation of the cavities formed by the cavities 4 or the cells 6 .

In one example of the invention, the ribs 7 or at least one rib 7 determines the perimeter of the cavity 4 or of the open cell 6 .

The ribs 7 project upwardly from the inner wall of the open cell 6 or cavity 4 in a substantially perpendicular manner.

In that case, the ribs 7 constitute the peripheral sides of the shell 6 or cavity 4 and define a flat base. The base opposite the flat base forms an opening (5). The cell 6 is therefore a cell that is open only at the mating surface 3 and closed around it.

The ribs 7 may also act as reinforcing elements for the prosthetic body 2 . Based on this additional function of the ribs 7, a cavity 4 is provided to ensure that the ribs 7 are located in parts of the prosthetic device 1 that experience large mechanical stresses such as wear, bending, fatigue, etc. during use. )'s location can be determined.

Moreover, the cavities 4 or cells 6 contain different filler materials 4' for each cavity, or filler materials 4' containing at least one pharmaceutical or medical substance that is different for each cavity. do. In this way, differentiated preventive measures or treatments can be performed on different areas of the bone or joint region.

According to another example, not shown in the figures, some or all of the cavities 4 or cells 6 may communicate with each other, for example by means of penetrations arranged in the ribs 7 .

Depending on the shape of the engagement surface 3 , ie depending on the type of prosthetic device 1 considered, the distance together with the mutual positioning between the single cavities 4 can vary.

As shown in Figure 1, the prosthetic body 2 may be associated with an insert 3'.

The insert 3' may be made of plastic or polymer material, for example polyethylene, polypropylene, polyester and other similar materials.

In particular, the insert 3' is made of a material that can facilitate articulation or sliding with the patient's bone tissue or other prosthetic elements at a particular joint or implantation site.

For example, to make the tibial insert 3', polyethylene UHMWPE can be used, which is a low friction material.

The insert 3' is, in one embodiment of the invention, positioned on the prosthetic body 2 in an opposing position with respect to the engagement surface 3, which is in contact with the bone or joint area.

The insert 3' and the prosthetic body 2 can be variably positioned relative to each other depending on the shape of the prosthetic device itself.

According to a configuration not shown in the drawings, the insert 3' may have at least one other cavity.

In Figure 4, another embodiment of a prosthetic device is shown, which may be restricted to the femoral end of the knee joint during use; Such a device is generally designated with reference numeral 100.

Hereinafter, identical components corresponding to components of the previously described embodiments will be denoted by the same reference numerals plus 100.

The prosthetic device 100 differs entirely from the above prosthetic device indicated by figure number 1 solely due to its shape, since the prosthetic device 100 represents a prosthesis that can be associated with the lower end of the femur at the knee joint. am.

The prosthetic device 100 is, in one example of the invention, configured to articulate with the prosthetic device 1 or possibly with the insert 3' during use.

Prosthetic device 100 includes a prosthetic body 102 that includes at least one surface 103 that engages the femoral end at the knee joint during use.

The prosthetic body 102 has a substantially “U” shape considering a section taken along a plane parallel to the sagittal plane of the human body.

In particular, the engagement surface 103 corresponds to a concave surface of the prosthetic body 102.

Moreover, the prosthetic body 102 or its mating surface 103 includes at least one cavity 104.

At least one cavity 104 defines a respective opening 105 , which extends along and/or through the at least one mating surface 103 .

According to one aspect of the invention, each cavity 104 and thus each opening 105 may comprise, have or receive a filler material 4'.

The shape, volume, and placement of the single cavity 104 may vary, for example, based on the shape of the prosthetic body 102.

In a preferred embodiment, the configuration of the cavity 104 or opening 105 is that of an open cell 6 .

Prosthetic device 100 includes an articular surface 103' opposing an engagement surface 103.

Articular surface 103' corresponds to a convex surface of prosthetic body 102.

Such articular surface 103' is configured to engage in an articulated manner with the insert 3' of the prosthetic device 1, or with the articular surface, or with the tibial part of the knee joint.

Articular surface 103' may accommodate other cavities not shown in FIG. 4.

The properties of cavity 104, filler material 4', cell 6 and opening 105 correspond to those previously described for prosthetic device 1.

5 and 6, another example of the present invention is shown, wherein a prosthetic device generally designated 200 includes a cotyloid portion or acetabular portion of a hip or shoulder prosthesis. Prosthetic device 200 includes a prosthetic body 202.

This embodiment has the same features as described for the previous embodiments, but with a change in terms of shape since the implantation site is different from that of the prosthetic device 1, 100.

Hereinafter, identical components corresponding to components of previously described embodiments will be denoted by the same reference numerals plus 100.

The prosthetic body 202 has a configuration similar to a dome or a hemisphere.

The prosthetic body 202 subtends the void or recess V.

The void or recess V has a hemispherical shape and is adapted to receive, if in use, a bony part of the head of the hip joint or shoulder prosthesis or the head of the femur or scapula, if substantially complementary.

The prosthetic body 202 is configured to be positioned and/or secured during use in/relative to a globular or non-spherical cavity present in a pelvic or shoulder joint of a human body.

The prosthetic body 202 includes a mating surface 203 and a medial or articular surface 203' opposing the mating surface.

The engagement surface 203 is convex and corresponds to the convex surface of the prosthetic body 202 and is configured to contact the patient's bone.

The medial surface 203' is concave and corresponds to the concave surface of the prosthetic body 202 and is configured to instead form an articulation of the corresponding bone portion. The concave portion of the articular surface 203' corresponds to a void or concave portion V.

Inserts for joints, not shown in the drawings, may be made of various types of materials, for example ceramic or polyethylene, and may be placed in contact with the inner surface 203' in a way that reduces friction caused by the joint.

The mating surface 203 includes one or at least one cavity 204. At least one cavity 204 may have variable volume, configuration and/or arrangement depending on the geometry of the prosthetic body 202 and depending on requirements.

In one example of the invention, at least one cavity 204 may take the configuration of at least one annular groove.

The grooves may be arranged at a certain distance from each other. The grooves may be positioned parallel to the diameter or parallel to the base of the prosthetic body 202 in a concentric manner.

In that case, the cavity 204 has an annular opening 205 in the mating surface 203; For the remaining features, cavities 204 are grooves extending to a certain depth within the material that makes up the prosthetic body 202.

In another embodiment, the at least one cavity 204 is disposed in a non-uniform manner along the mating surface 203; When there is more than one cavity, they may have different shapes and volumes.

Each body 204 defines a corresponding opening 205 extending through a mating surface 203 .

The openings 205 correspond to a space capable of receiving the filler material 4' therein.

Also in this case, in one example of the invention, the bonding surface 203 may comprise a coating of filler material 4' of similar size with respect to the size of the bonding surface itself.

7 and 8 show another example of the present invention, where the prosthetic device 300 includes a prosthetic body 302 having a stem-like shape.

The prosthetic body 302 has an elongated shape and is adapted to form the stem of a hip or shoulder prosthesis.

Prosthetic device 300 may include a head corresponding to the femoral head of the hip joint, in the example for a hip prosthesis, such that it is articulated with the patient's cotyloid or with prosthetic device 200. It is composed.

The prosthetic body or stem 302 includes an end (E). End E represents the proximal end of the prosthetic body 300, which is configured to engage with the head of the prosthesis, if present.

Moreover, the prosthetic body 300 includes a distal end (E') that opposes the end (E') during use. The distal end (E') is configured to be implanted into the femoral medullary canal or into the patient's shoulder blade.

7 and 8, the proximal end E has a conical shape. However, such shape is not limited in the present invention, and the end E may have other shapes or forms.

The prosthetic body 300 further includes a connecting portion R, which is disposed at the proximal end E, and includes an elongated body 302', which constitutes a stem-like element of the prosthetic body 302, and a proximal end ( E) is configured to connect.

The elongated body 302' or prosthetic body 302, which constitutes a stem-like element, includes at least one engagement surface 303, which is configured to contact bone tissue or a grafted bone site during use.

Along such engagement surface 303, there is at least one cavity 304, which contains, has or is configured to receive filler material 4'.

In one example of the invention, at least one cavity 304 has a groove-like shape. In particular, at least one such groove has a longitudinal progression, which is parallel to the longitudinal axis of the elongated body 302', which constitutes the stem of the prosthetic body 302.

Each groove or cavity 304 identifies a separate opening 305.

Even in this case, at least one cavity 304 has a geometry, volume and/or arrangement that varies depending on requirements or depending on the implantation site.

In the examples shown in FIGS. 7 and 8 , cavity 304 has an extension substantially equal to the distance from the connecting portion (R) to the distal end (E') of the prosthetic body 302 or stem-like element. Appears as a groove or slot.

In an alternative example, not shown, the cavity 304 may have partial or zonal extension.

Moreover, in the examples shown in FIGS. 7 and 8 , the prosthetic body 2 is provided with a stem-like element of substantially rectangular cross-section, with two opposing sides having a greater width than the other opposing sides, and comprising at least one The cavities 304 of can be arranged on large surfaces. Nevertheless, such configurations are only non-limiting examples of the present invention.

In another example, the elongated body 302' making up the stem element includes a coating of filler material 4' disposed in contact with the entire surface of the stem itself, the surface being exposed to the patient's bone tissue during use. It is configured to be placed in contact. When impinging on the stem of the prosthetic body 302, the coating of filler material 4', in one example of the invention, should have a hard and/or compact consistency. For example, to obtain a coating of such a filler material 4', it is possible to use porous ceramics, terracotta, materials with hard hardness or plastic materials, i.e. materials that can ensure a certain strength. In any case, if the prosthetic device 1 is immersed in a solution containing a pharmaceutical or medical substance or a therapeutic solution, the coating is porous or contains small channels in such a way that it can penetrate.

Moreover, the presence of pores or small channels allows the prosthetic device 300 to release at least one pharmaceutical or medical substance for treatment, prevention or healing of bone or joint areas of the body.

The invention thus conceived allows the acquisition of technical advantages.

Above all, the advantage of being able to use the prosthesis of the present invention in conjunction with conventional prosthetics is that it allows treatment and/or prevention of bone or joint infections without the need for interference with one-stage or two-stage treatment.

Moreover, despite the presence of at least one cavity filled with filler material, a prosthetic device is obtained with mechanical properties comparable to those of a standard prosthesis.

Furthermore, the presence of cavities that can be independent of each other makes it possible to construct a prosthetic device capable of releasing more than one type of pharmaceutical or medical substance at the bone or joint area to be treated.

The present invention relates to a method of manufacturing a prosthetic device (1, 100, 200, 300).

The method comprises the steps of obtaining a prosthetic body (2, 102, 202, 302) having a shape substantially complementary to the shape of the bone or joint area to be implanted or treated and provided with at least one cavity (4, 104, 204, 304), at least Providing at least one filler material (4') comprising one pharmaceutical or medical substance and capable of being mixed with the at least one pharmaceutical or medical substance, placing the at least one filler substance (4') in at least one cavity ( 4,104,204, 304) provides insertion steps.

In one example of the invention, the method comprises obtaining a prosthetic body (2, 102, 202, 302) having a shape substantially complementary to the shape of the bone or joint area to be implanted or treated, including at least one pharmaceutical agent. or providing at least one filler material (4') comprising a medical substance or capable of being mixed with at least one pharmaceutical or medical substance, at least one engagement surface (3, 103, 203) of the prosthetic body (2, 102, 202, 302). , coating 303) with at least one filler material (4').

The filler material 4' may contain at least one pharmaceutical or medical substance or may be mixed with it, absorbable or impregnated with the pharmaceutical or medical substance. Accordingly, the method can provide for immersing or impregnating the filler material 4' with at least one pharmaceutical or medical substance. In this way, an accumulation of pharmaceutical or medical substances takes place in the porous material comprised in the prosthesis according to the invention. Once the prosthesis is implanted in the bone, the accumulated pharmaceutical or medical substances are released or extracted from the prosthetic material and enter the surrounding prosthetic tissue, healing it.

The method may further include creating a single body with the prosthetic body 2,102,202,302 by waiting for the filler material 4', which may be of a coagulable type (e.g., bone cement), to cure, or the filler material. It may further include solidifying the filler material 4' in such a way that the prosthetic body (4') forms a single body with the prosthetic body (2, 102, 202, 302).

The method includes providing at least one insert (3') and securing or relating the insert (3') to a prosthetic body (2, 102, 202, 302) and/or positioning the insert (3'), where there may be an insert (3'). ') with the prosthetic body 2,102,202,302, thereby forming an articulating surface with bone tissue or other prosthetic components with limited friction.

In one embodiment of the invention, the method includes disposing at least one pharmaceutical or medical substance and submerging a prosthetic device within the at least one pharmaceutical or medical substance or impregnating the prosthetic device with the at least one pharmaceutical or medical substance. may include.

Finally, the prosthetic device 1,100, 200, 300 is implanted into a bone or joint area during use.

In one example of the invention, the prosthetic device 1, 100, 200, 300 includes a coating and cavities made with filler material 4'.

In any case, the cavities 4, 104, 204, 304, when present, are to be filled with the filler material 4' and flush with the joining surfaces 3, 103, 203, 303 of the filler material 4'. It has a shape that does not require a mold to maintain the surface.

As is clear from the above description, the at least one cavity and/or coating is disposed on at least part of the engagement surface and thus on the outer surface of the prosthetic device according to the invention.

If such a surface is in contact with the surrounding bone tissue during use, the opening of the cavity and/or the filler material and/or coating may be removed by the surrounding bone tissue or by the bone cement used to hold the prosthesis itself in place during implantation. "closed" or in contact with it.

Accordingly, between the bone cement and/or bone tissue used to hold the prosthetic device in place, contact with the filler material of the coating occurs and/or is received in at least one cavity.

Once in place, the prosthetic device 1, 100, 200, 300 releases at least one pharmaceutical or medical substance present therein in a gradual and substantially uniform manner to the area to be treated or to the implantation site.

In at least one example of the present invention, the prosthetic device 1,100,200,300 is capable of adjusting the porosity and/or shape and/or properties of the filler material 4' without the need to create suitable slits or grooves for ejection of pharmaceutical or medical substances. At least one pharmaceutical or medical substance may be released directly due to this.

Prosthetic devices 1, 100, 200, and 300 are permanent.

Additionally, the method makes it possible to obtain technical advantages.

First of all, the method allows for a prosthetic device that can prevent and treat infections in bone or joint areas in a few simple steps.

Next, the method described above allows the placement of a prosthetic device to be effective in preventing and treating infections in bone or joint areas; Such devices essentially comprise at least one pharmaceutical or medical substance that is released at the bone or joint site in a way to combat infection when it is already in progress or to prevent the onset of infection.

The invention so conceived can undergo various improvements and modifications, all of which fall within the scope of the concept of the invention.

Features present in one example or embodiment may be combined with features of another example or embodiment without departing from the protection scope of the present invention.

As explained, the prosthetic device according to the invention may comprise, contain, receive or be mixed with at least one pharmaceutical or medical substance, such as for example at least one antibiotic. In that way, pharmaceutical or medical substances accumulated at the interface or within the prosthetic device itself will be released or extracted from the materials of the prosthetic device itself once the device is implanted in the body during use. At least one pharmaceutical or medical substance is in contact with said bone tissue, so that treatment or drug treatment of the bone tissue surrounding the prosthetic device is thus achieved.

In one example of the invention, a kit is provided comprising a prosthetic device according to the invention and a filler material of the type described above.

In one example of the invention, the prosthetic device according to the invention is preformed. According to that aspect, a prosthetic device is intended which, by definition preformed, is provided with a filler material 4' in advance, the filler material being positioned on at least one engagement surface and/or inside at least one cavity. Preformed prosthetic devices are therefore already supplied with filler material at the time of sale and are thus ready for use.

Moreover, all details can be replaced by technically equivalent elements.

In practice, the materials used as well as the accompanying shapes and sizes may be of any type, depending on the requirements, without departing from the scope of protection of the following claims.

1. Prosthetic device 2. Prosthetic body
3. Bonding surface 4. Cavity
6. Open cell 7. Ribs

Claims (16)

A permanent type of prosthetic device (1, 100, 200, 300) that is implantable into a human bone or articulation seat and includes a prosthetic body (2, 102, 202, 302), The prosthetic body (2, 102, 202, 302) includes at least one engagement surface (3, 103, 203, 303) adapted to contact in use with the bone or prosthetic sheet,
At least one said engaging surface (3, 103, 203, 303) comprises at least one cavity (4, 104, 204, 304), wherein at least one cavity comprises a filler material (4) comprising a pharmaceutical or medical substance. ')(filler material),
The prosthetic device (1, 100, 200, 300) is designed to prevent and/or treat infections that may cause ongoing infection in the bone or joint sheet of the human body when used, and the filler material (4') is in solid form or in the form of a solidifiable fluid, wherein the at least one cavity (4, 104, 204, 304) is polyhedral or parallelepiped-shaped, wherein only one face of the shape is defined by an opening with a side and the shape A prosthetic device (1, 100, 200, 300), characterized in that the planar dimension and the lateral dimension of only one side of the prosthetic device (1, 100, 200, 300) are longer than the depth of the interior cavity of the prosthetic device (1, 100, 200, 300). 2. The method of claim 1, wherein the mating surface (3, 103, 203, 303) of the prosthetic body (2, 102, 202, 302) has an open cell ( 6) A prosthetic device (1, 100, 200, 300) comprising a plurality of cavities (4, 104, 204, 304) adjacent to each other to form. 3. The method of claim 2, wherein the open cells (6) or cavities (4, 104, 204, 304) are separated from each other by ribs (7) and/or are separated by a perimeter by at least one rib (7). A prosthetic device (1, 100, 200, 300) is formed. 4. The method of claim 3, wherein the ribs (7) comprise walls interposed between the open cells (6) or cavities (4, 104, 204, 304), the walls being located between the open cells (6) or cavities (4, 104, 204, 304). Prosthetic device (1, 100, 200, 300) raised at right angles from the inner wall of 4,104,204,304). 2. The prosthetic body (2, 102, 202, 302) according to claim 1, wherein the prosthetic body (2, 102, 202, 302) comprises an inner hollow stem (S) with an aperture (F) adapted to deliver pharmaceutical or medical substances. A prosthetic device (1, 100, 200, 300), wherein a pharmaceutical or medical substance is present in the filler material (4'). 2. The prosthetic device (1, 100, 200, 300) according to claim 1, wherein the prosthetic device (1, 100, 200, 300) comprises an insert (3') that can be fixed to the prosthetic body (2, 102, 202, 302), wherein the insert (3') has a low friction Prosthetic devices, made of low friction plastic or low friction polymer materials (1, 100, 200, 300). The prosthetic device (1, 100, 200, 300) according to claim 6, wherein the insert (3') comprises at least one cavity (4, 104, 204, 304). 2. Prosthetic device (1, 100, 200, 300) according to claim 1, wherein the filler material (4') is flush with or protrudes relative to the engagement surface (3, 103, 203, 303). . The prosthetic device (1, 100, 200, 300) according to claim 1, comprising filler material (4') in at least one of said cavities (4, 104, 204, 304). The prosthetic device (1, 100, 200, 300) according to claim 1, wherein the prosthetic body (2) is made of biologically compatible materials, such as metals, metal alloys, organometallic compounds, ceramics or combinations thereof. . 11. The method of claim 10, wherein the biologically compatible material is an acrylic resin, a plastic material, a ceramic material, a high porosity resin, bone cement or polymethyl methacrylate (PMMA), a thermoplastic polymer. , polyethylene, polypropylene, polyester, thermoforming polymers, metal nitrides and/or metal oxides such as titanium nitride or combinations thereof, or porous ceramics, terracotta, plastic materials or hard consistency materials. Contains or contains acrylic resin, plastic material, ceramic material, high porosity resin, bone cement or polymethyl methacrylate (PMMA), thermoplastic polymer, polyethylene, polypropylene, polyester, thermoforming A prosthetic device (1, 100, 200, 300). The method of claim 1, wherein the filler material (4') is an acrylic resin, a composite material containing calcium phosphate or an inorganic salt, calcium sulphate, bioglass, polyvinyl alcohol. Or a prosthetic device (1, 100, 200, 300) comprising an absorbent material or a mixture thereof. A permanent type of prosthetic device (1, 100, 200, 300) which, in use, is intended to be implanted into a bone or joint sheet of a human body and is intended to prevent and/or treat infections that may cause progressive infection in said bone or joint sheet of a human body ) As a manufacturing method,
Obtaining a prosthetic body (2, 102, 202, 302) having a shape complementary to the shape of a bone or joint sheet into which the prosthetic body is to be inserted when used, wherein the prosthetic body is in contact with the bone or joint sheet when used. obtaining a prosthetic body, provided with at least one engagement surface (3, 103, 203, 303) adapted to do so;
providing a filler material (4') comprising a pharmaceutical or medical substance, wherein the filler material (4') is in solid form or in the form of a coagulable fluid; and
Inserting the filler material (4') into at least one cavity (4, 104, 204, 304) present in the at least one mating surface (3, 103, 203, 303), wherein the filler material (4) ') is in the form of a solid or a solidifiable fluid, wherein the at least one cavity (4, 104, 204, 304) is polyhedral or parallelepiped-shaped, and only one face of the shape is defined by an opening with a side, a prosthetic device (1, 100), comprising an insertion step, wherein the planar dimension and the lateral dimension of only one side of the shape are greater than the depth of the interior cavity of the prosthetic device (1, 100, 200, 300). , 200, 300) manufacturing method. According to claim 13,
allowing the filler material (4') to solidify so that the filler material (4') forms a single body with the prosthetic body (2, 102, 202, 302);
Providing at least one insert (3'), combining the insert (3') with the prosthetic body (2, 102, 202, 302) or fixing it to the prosthetic body (2, 102, 202, 302) step; and
A prosthetic device (1, 100, 200) comprising at least one of: immersing the filler material (4') in the pharmaceutical or medical material or impregnating the filler material (4') with the pharmaceutical or medical material. , 300) manufacturing method. A kit comprising a prosthetic device (1, 100, 200, 300) of a permanent type according to any one of claims 1 to 12 and a filler material (4') comprising a pharmaceutical or medical substance. wherein the filler material 4' is in solid form or in the form of a coagulable fluid,
A kit according to claim 1, wherein the prosthetic device (1, 100, 200, 300) is adapted to prevent and/or treat infections that may lead to progressive infections in the bones or joint sheets of the human body.
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