ITUB20159763A1 - PROSTHETIC DEVICE FOR THE HUMAN BODY AND METHOD FOR ITS REALIZATION - Google Patents

Description

about 1 (H) micron.

There is a preliminary version of the present invention. the filling material 4 'comprises an acrylic resin and an inorganic salt, for example Ι'ΜΜΛ (polymethylmethacrylate) and calcium phosphate or tri calcium phosphate (TCP).

In an eight possible configuration, as shown in Figures 1-4, the prosthetic device has a plurality of cavities 4 placed along the coupling surface 3.

According to a version not shown, the depth of the cavities 4 inside the prosthetic body 2 can be variable with respect to each other within the same device 1.

In addition, the position of the cavities 4, their number and their frost can vary according to specific needs.

I, and the dimensions of the cavities 4 can in any case be variable also as a function of the dimensions of the prosthetic body 2.

Each cavity 4 constitutes a corresponding opening 5 which extends through the coupling surface 3.

In an embodiment, as shown in Figure 3. some cavities 4 may have elements C suitable for allowing the identification of the correct positioning of the prosthetic device I in the bone or joint. In this case, it is possible, for example, that a specific instrument set for the prosthesis in question is present in the socket with a mask or collimation template.

As already mentioned above, the <'> at least my cavity 4 acts as a housing for a filling material I'. In fact, inside at least one opening 5 or only in some openings 5. if there is a plurality of cavities 4 in the prosthetic body 2, a filling material P is included, contained or housed, which can comprise at least a pharmaceutical or medical substance that is released inside the human body of the patient.

In a possible version of the invention, the filling material 4 'c prepared and positioned in the cavity 4 by the surgeon before implanting the prosthetic device itself, that is, during the operating procedure. The prosthetic device I, as mentioned, has a configuration such that the filling material 4 'is in contact with the bone or joint tissues to be treated or implanted, consequently this filling material 4' fills the cavity 4 so as to be flush with the coupling surface 3 or protruding with respect to the coupling surface 3. In this way, a continuous surface is created with the coupling surface 3 of the prosthetic body 2.

Λ depending on the estimated time period necessary for the release of at least one pharmaceutical or medical substance in the bone or joint site of the implant, the total volume occupied by the at least one cavity 4 can vary, so that the prosthetic device I can guarantee the release of at least one human pharmaceutical substance for the entire chosen period.

In a further version of the present invention, the prosthetic device 1. in correspondence with the coupling surface 3. comprises Limi cavity I having dimensions substantially corresponding to the line of the coupling surface 3 itself: this cavity 4 is filled with the filling material 4. configuration of the cavities 4 can be such as to define the open cell structure 6 along the coupling surface 3.

The aporian cell structure 6 comprises a plurality of cells placed next to each other, each of which corresponds to the cavities 4,

The open cells 6 or the pins 4 are separated from each other by ribs 7

These ribs 7 represent walls interposed between the cavities 4 themselves or between the cells 6 themselves, which allow a physical division of the spaces defined by these cavities 4 or cells f>.

In one version of the invention, the ribs 7 in at least one rib 7 determine the perimeter of the cavities 4 or the open cells 6.

The ribs 7 rise substantially perpendicularly from an internal wall of the open cells h or of the cavities 4,

The ribs 7 can also act as ritual elements for the prosthetic body 2. On the basis of this further function of the ribs 7, the cavities 4 can be positioned in such a way as to guarantee the presence of the ribs 7. of the portions of the prosthetic device I which, in use, are subjected to greater mechanical stresses, for example wear, flexion, lalica, de.

Furthermore, it is possible that these cavities 4 or cells 6 contain filling material 4 "diftèrenle from a cavity airallrn a material 4 <*> containing at least one pharmaceutical or medical substance different from one cavity to another. In this way, it is possible to carry out a differentiated preventive or curative treatment for the different atheists of the bone or joint site.

According to a further version not shown in the attached figures, some or all of the cavities 4 or cells 6 can be in communication with each other, for example by means of holes placed in correspondence with the ribs 7.

Λ according to the conformation of the coupling surface 3, that is, according to the type of prosthetic device I considered, the distance as well as the reciprocal positioning between the individual cavities 4 can vary.

Conte shown in figure I, the prosthetic body 2 can be associated with an insert 3 <*>.

the insert wing 3 'can be made of plastic or polymeric material, such as polyethylene, polypropylene, polyester, and other similar materials.

In particular, the insert 3 'is made of a material capable of facilitating the sliding or connection with a further prosthetic component or with the patient's bone tissue, in correspondence with the specific joint of the implant site.

For example, for the realization of the tibial inseno V, polyethylene Ul IMWPl can be used, which is a low friction material

Said insert 3 ', in one version of the invention, is positioned on the prosthetic body 2, in the opposite position with respect to the coupling surface 3, which coats with the bone or joint seat.

1 / insert 3 'and the prosthetic body 2 can have a variable positioning with respect to the other according to the conformation of the prosthetic device itself.

According to a configuration not shown in the figures, the insert V may possibly have at least one further cavity.

Figure 4 illustrates a further embodiment of a prosthetic device that can be constrained in use at the lemoral end of the knee joint, which device is indicated as a whole with 100.

Hereinafter, the same COIII | H> I attempts corresponding to those of the previously described embodiment will be indicated with the same reference numbers increased by one hundred units.

The prosthetic device tl.10 as a whole differs from the previous prosthetic device, indicated with the number I, solely for its configuration, as this device 100 represents a prosthesis that can be associated with the lower end of the femur, in correspondence with the knee joint .

The prosthetic device I1K) is adapted, in a version of the invention, to articulate in use with the prosthetic device I or better with its possible insert 3 <*>.

The prosthetic device 100 thus forms a prosthetic body 102 comprising, in turn, at least one coupling surface 103, in use. with the femoral bone end in correspondence of the knee joint.

The prosthetic body H> 2 has my substantially "II" conformation. In particular, the coupling surface 103 corresponds to the concave surface of the prosthetic body 102. Furthermore, the prosthetic body 11 (2. Or rather its coupling surface 103, comprises at least one cavity 104.

I. at least one cavity 104 determines a respective opening 105 which extends along and / or through the ahueno a coupling surface 103. According to an aspect of the present invention, each cavity 104, therefore each opening 105, can comprise, contain or house a filling material 4 <*>.

The shape, volume and arrangement of the individual cavities 104 can vary, for example on the basis of the conformation of the prosthetic body 102. In a preferential embodiment, the configuration of these cavities 104 or openings 105 is open cell (>.

The prosthetic device 100 comprises an articulation surface 103 "opposite the coupling surface 103.

I .a. Articulation surface 103 "corresponds to the convex surface of the prosthetic body 102.

This articulation surface 103 "is adapted to be associated in an articulated manner to the tibial portion of the knee joint or to the articulation surface or to the insert 3 'of the prosthetic device I The articulation surface 103". optionally, it can house further cavities, not shown in figure 4. The characteristics of the cavities 104, of the material Γ and of the openings 105 correspond to those previously described for the prosthetic device I.

Figures 5 and 6 show a further version of the present invention, in which the prosthetic device, indicated as a whole with 200. comprises a votile or an acetabular portion of a hip or shoulder prosthesis. The prosthetic device 200 comprises a prosthetic body 202.

Ί alt? The embodiment has the same characteristics described for the previous embodiments, but varies in the configuration as the implant site is different from that of the prosthetic devices I and UH),

Hereinafter, the same components corresponding to those of the embodiments described above will be indicated with the same reference numbers increased by one hundred units.

The prosthetic body 202 has a dome or hemisphere configuration.

The prosthetic body 202 subtends an empty space or concavity V.

The empty space or concavity V has a hemispherical conformation and is adapted to house in use a head of a hip or shoulder prosthesis or the bony portion of the head of the femur or of the shoulder bone. being substantially complementary to it

The prosthetic body 202. in use, is adapted to be positioned and / or fixed in / to the acetabular cavity and the eotyloid is present at the level of the human pelvis or shoulder joint.

The prosthetic body 202 comprises a coupling surface 203 and an internal or articulation surface 203 'opposite the coupling surface 203.

The coupling surface 203 is convex, corresponds to the convex surface of the prosthetic cup 202 and is adapted to enter into the patient's ditch.

fa internal surface 203 'is concave, corresponds to the concave surface of the prosthetic body 202 and is suitable, instead, to create the articulation of the corresponding bone site, concavity of the articulation surface 203 <*> corresponds to the empty space or concavity V.

An articular insert, not shown in the figures, made of various types of material, for example ceramic or polyethylene, can be positioned in contact with the internal surface 203 '. in such a way as to decrease the friction caused by! the joint.

The coupling surface 203 comprises one or at least one cavity 204. The at least one cavity 204 can have variable volume, configuration and / or arrangement according to the geometry of the prosthetic body 202 and according to requirements.

In one version of the invention, the at least one cavity 204 can take the configuration of at least one annular groove.

groove vials can be arranged at a constant distance from each other, groove vials can be positioned concentric and parallel to a diameter of the prosthetic body 202.

In a further embodiment. Γ at least one cavity 204 is arranged in a non-uniform manner along the coupling surface 203 and have different sizes and volumes from each other.

Each cavity 2tM determines a corresponding opening 205 which extends through the coupling surface 203.

The openings 205 correspond to a space within which the filling material 4 can be housed. Also in this case, in one version of the invention, the coupling surface 203 can comprise a covering of filling material 4 of dimensions similar to those of the mating surface itself.

Figures 7 and 8 show a further version of the present invention, in which a prosthetic device 300 comprising a prosthetic body 302, which has a stem conformation.

The prosthetic body 302 has an elongated my lóntra and is suitable for forming the stem of a hip or shoulder prosthesis.

The prosthetic device 300 may include, in the version relating to a hip prosthesis, a lesta corresponding to the femoral head of the hip irliculation. able to articulate with a patient's neck or with the prosthetic device 2 (H).

The prosthetic body or stem 102 comprises an end K, I. The end P. represents the proximal end of the stem. prosthetic body .11) 0, to mate with the prosthesis head, when present,

Furthermore, the prosthetic body 100 comprises a distal end L '. opposite in use with respect to the li end. The 'distal end P' is adapted to be implanted inside the medullary femoral canal or in the patient's shoulder bone.

In the embodiment shown in Figures 7 and K. the proximal end P has a truncated cone connection, the conformation is in any case not limiting to the present invention and the end I ·. it can also have <1> other conformations or shapes.

The prosthetic body 100 further comprises a connecting portion K, placed at the proximal end P and adapted to match the proximal end P with an elongated body 302 <*> which constitutes the stem element of the prosthetic body 102.

The prosthetic body 302 or stem assembly 302 "comprises at least one coupling surface 301 to come into lyso contact with the bone stem or bone implant site.

On the single coupling surface 303 there is one or at least one cavity Id i. able to comprise, contain or house the filling material 4 ".

In one version of the invention, the at least one cavity 304 has a groove shape. In pnrlieolar. such at least one groove has a longitudinal course, parallel to the longitudinal axis of the stem element 302 'of the prosthetic body 302.

Each groove or cavity 304 identifies an inspection opening 305.

Also in this case, the at least one cavity 104 has a geometry, volume or arrangement which varies according to the implant site and according to requirements.

In the version shown in Liguria 7 and 8, the cavities 304 are presented in the lormu of grooves or grooves having an extension equal to the distance from the portion K to the distal end fi <'> of the stem element or prosthetic body 302.

In an alternative version, not shown in the figures, these cavities 104 could have a partial or zone extension.

Again, in the version illustrated in Figures 7 and 8. in which the prosthetic body 2 has a stem element having a substantially rectangular cross-section, having two opposite pockets of greater width than the other opposite sides, the at least one cavity 304 can be placed in correspondence with the larger Iaceae. This configuration, however, is only exemplary and does not limit the present invention.

In a still further version, the stem 302 'comprises a coating of filling material 4' placed in correspondence with and in contact with the entire surface of the stem itself, suitable for being put into use in contact with the patient's bone tissue. when it affects the stem 102 ', the coating of filling material 4' must have, in one version of the invention, a hard and / or compact consistency. For example, it is possible to use, to obtain such a coating of filler material 4 <'>. porous ceramic, terra cotta, plastics or hard consistency, i.e. materials capable of guaranteeing a certain resistance. However, the! c porous coating or including canaliculi, in such a way that the prosthetic device I, once immersed in a medicated solution or containing a pharmaceutical or medical substance, is able to impregnate it

The invention thus conceived allows to obtain technical advantages.

First of all, the advantage of being able to use a prosthesis that. compared to traditional ones, it allows prevention and / or treatment of bone or joint injections, without the need to intervene with a treatment in one or two cases.

Furthermore, despite the presence of at least a cavity filled with filling material, a prosthetic device is obtained with mechanical characteristics comparable to those of the standard prosthesis.

In addition, the presence of cavities that can be independent from the others allows to prepare a prosthetic device capable of releasing more than one type of pharmaceutical or medical substance into the bone or joint to be treated, the present invention then relates to a method for the realization of a prosthetic device 1. 100. 200. 300.

This method prevails over the steps of obtaining a prosthetic body 2. 102. 202, 302 having a conformation substantially complementary to that of the bone or joint site of the implant or to be treated or equipped with at least one cavity 4.! 04, 204 304. to turn at least one filling material 4 <'> comprising at least one pharmaceutical or medical substance u which can be added with at least one pharmaceutical or medical substance, for insertion at least one cavity 4, 104. 204. 30 I of the at least one filling material T

In one version of the invention, the method comprises the steps of obtaining a prosthetic body 2, 102.

202, 302 having a conformation substantially complementary to that "in the bone or joint site of the implant or" the treatment, of lomining at least one filling material 4 'comprising at least one pharmaceutical or medical substance or which can be added with at least one pharmaceutical or medical substance, to cover at least one coupling surface ic .3, 103. 203, 203 of the prosthetic body 2, 102, 202.> 02 with Γ at least one filling material Γ.

The filling material 4 'includes or is additional to it or is capable of absorbing or imbibing with at least one pharmaceutical or medical substance. Therefore the method can foresee to immerse or soak the filling material 4 "with Palmello a pharmaceutical or medical substance. In this way, the accumulation of the pharmaceutical or medical substance in the porous material coiilouiiU) in the prosthesis according to the present invention is determined. The pharmaceutical or medical substance accumulates it, once the prosthesis is implanted in the bone, it will exit or elute the prosthetic material and enter the periprolesic tissues, medicating them.

The method may further comprise a step of waiting for the filler material "4 <’>. which can be of the soìidilicabile type (for example bone cement), hardens, creating a single body with the prosthetic body 2. 102. 202. 302 itself or to solidify the filling material 4 <">, so that the filling material 4 'form a single body with the prosthetic body 2. 102, 202, 302.

The method can also foresee a Step of providing at least one insert 3 "and associating or fixing the insert 3 <'> with the prosthetic body) 2. 102. 202. 302, and a" positioning an eventual inserts "3' and couple the insert 3 'with the prosthetic body 2, 102. 202. 302. thus causing a loss of articulation with another prosthetic component or with the bone tissue having reduced friction.

In a version of the invention, the method may comprise the steps of preparing at least one pharmaceutical or medical substance and immersing or soaking the prosthetic device inside at least one pharmaceutical or medical substance.

latine, the prosthetic device 1. 10 (1, 200, 300 is used implant in correspondence of the bone or joint.

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

The pyostatic device 1, 100, 200, 100 is permanent.

Anelie the aforesaid method allows to obtain the technical advantages.

First of all, this method allows to obtain in a few simple steps a prosthetic device capable of both preventing and treating an infection of the bone or joint site.

Secondly, the method described makes it possible to have a prosthetic device effective in preventing and CIUM injections of the bone or joint site: this device contains intact at least one pharmaceutical or medical substance, to be released in correspondence with the bone or joint site. to prevent the onset of an injection or to eradicate it, when already high.

(The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the inventive concept.

The features presented for one version or embodiment can be combined with the features of another version or embodiment, without departing from the scope of protection of the present invention,

As we have seen, the prosthetic device according to the present invention comprises, contains, houses or is suitable for use with at least one therapeutic or medical substance, for example at least one antibiotic. In this way, this kirmaeeutic or medical substance, accumulated at the interface or inside the piostic device itself, once in use the device is implanted in the human body, will come out or be eluted from the material of the prosthetic device itself. In this way, the treatment or dressing of the bone tissues surrounding the prosthetic device is obtained, with which a pharmaceutical or medical substance comes into contact with Palmello.

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

In one version of the invention, the prosthetic device according to the present invention is preformed. According to this aspect, the definition of preform means a prosthetic device already equipped with filling material 4 <'> on the ahneno a coupling surface. The pre-formed prosthetic device, periamo, is sold already equipped with filling material and therefore ready for use.

Furthermore, all the details can be replaced by other technically equivalent elements.

In practice, the materials used, as well as the contingent shapes and dimensions, may be any according to requirements without thereby abandoning the protection of the following claims.

Claims (1)

CLAIMS Prosthetic device (I, 100. 200. 300), implantable in a bone or joint site of the human body, comprising a prosthetic body (2. 102, 202, 302), said prosthetic body (2. 102. 202. 302) comprising at least one coupling surface (3, 103. 203, 303) suitable for coming into contact in CIMI use said bone or joint seat, characterized by the rat that said at least one coupling surface (.3. 103, 203. 303) comprises at least one cavity (4, 104. 201. 304) adapted to comprise, contain or house a filling material (4 ') comprising at least one pharmaceutical or medical substance added to at least one pharmaceutical or medical substance or by the fact that said at least one surface coupling (3, 103, 203, 303) comprises at least one coating of the filler material (4 ') comprising at least one pharmaceutical or medical substance or addition to it with at least one pharmaceutical or medical substance. Prosthetic device (I. 100, 200, 300) according to claim !, wherein said coupling surface (3, 103, 20.3. 303) of said prosthetic body (2, 102. 202, 302) comprises a plurality of cavities ( 4. 104. 204, 304) adjacent to each other, so as to define an open cell structure (6) along said coupling surface (3. 103, 203. 303), 3 Prosthetic device (l. 100, 200. 300) according to claim 2. in which said open cells (0) or cavities (4, 104, 204, 304) are separated from them by ribs (7) and / or have a perimeter formed by at least one rib (7). 4. Prosthetic device (1, 100, 200, 300) according to the preceding claim, wherein said surfaces (7) comprise interposed walls Ira of the open cells (0) or cavities (4, 104, 204. 304), extending in substantially perpendicular to an inner wall of open cells (6) or cavities (4. 104, 204, 304). s Prosthetic device (1, loti. 200. 300) according to any one of the preceding claims, said prosthetic body (2, 102. 202, 302) comprises an internally hollow stem tS), comprising holes (Π adapted to deliver at least one pharmaceutical or medical substance present or added to said filling material (4 ') fi Prosthetic device <I. 100, 200, 300) according to any one of the preceding claims, wherein said prosthetic device (1, 100, 200, 300) comprises an insert (3 ') which can be associated or fixed to the prosthetic body (2, 102 , 202. 302), in which the insert (3 ') is made of low friction plastic or polymeric material. 7, Prosthetic device (I, 100, 200, 300) according to the previous claim, wherein said insert (3 ') comprises at least one cavity {4. 104, 201, 304). X, Prosthetic device (I. IOO, 2U0. 300) according to any one of the preceding claims, wherein said filling material (4 '> is flush or protruding with respect to said coupling surface (3, 103. 203. 303), 9. Prosthetic device (1, 100. 200. Ititi) according to claim I. comprising a filling material (4 ') in said at least one cavity {4, 104, 2 <(> M. 304). 10 Prosthetic device (1, 100, 200, 300) according to one of the preceding claims, in cite said prosthetic body (2) is made of a biologically compatible material, such as metal, metal alloy, organic compounds -metallics, ceramics or a combination of the same. 11. Prosthetic device {1, 100, 200. 200) according to the preceding claim / ion, wherein said biologically compatible material comprises or is at least partially coated with acrylic resin, plastic material, ceramic material, high porosity resin, bone cement or polymethyl methyls snuff (ΡΜΜΛ), thermoplastic polymers, polyethylene, polypropylene, polyester, thermofomable polymers, metal oxides and / or nilriirt, cyan for example titanium nitride or a combination thereof or porous ceramic, terra cotta, plastics or consistency tough. 12. Prosthetic device <I, IÌK). 200, 100) according to any one of claims 1 or 9, in which said filling material (4 ') is in solid form or in solidifiable fluid form. Prosthetic device (I, 100, 200, 300) according to any one of claims 1, 0 or 12. wherein said filling material (I ') comprises acrylic resin, composite material comprising calcium phosphate or an inorganic salt, calcium sulphate , bi-glass, polyvinyl alcohol or a mixture thereof or an absorbent material, T he Method for the realization of a prosthetic device (1, 100, 200, 300) suitable for being implanted in use in a bone or joint site of the human body comprising the phases of to obtain a prosthetic body (2. 102. 202. 302) having a conformation substantially complementary to that of the bone or joint seat in use in use, it must be inserted and equipped with at least my coupling surface <3, 10.3, 203, 303) suitable to come into contact in use with said bone or joint site, providing a filler material (4 ") comprising at least one pharmaceutical or medical substance or which can be added with at least one pharmaceutical or medical substance. insert said filling material (4 ") in at least one cavity <4. 104, 204. 304) present in said at least one coupling surface (3, 103. 203. 303) or cover with said filling material (4 ') the at least a coupling surface (3, 103, 20.3, 303). Method according to claim 14, comprising at least one of the following steps: lar solidify of the filler material (4 <*>). so that said filling material (4 <*>) forms a single body with said prosthetic body (2, 102, 202, 302)), providing at least one insert (T) to associate or fix said insert (3 ') with said prosthetic body (2, 102. 202. 302). immerse or soak said filling material <4 ') with said at least one pharmaceutical or medical substance. 16. Kit comprising a prosthetic device f i, 100. 200. 300), according to any one of claims 1 to 13, was a filling material (4 ') comprising at least one pharmaceutical or medical substance or additional with at least one pharmaceutical or medical substance.