SENSORED COMPONENT FOR ENDOSSEOUS SCREW, SCREW ASSEMBLY COMPRISING SAID COMPONENT, AND MONITORING SYSTEM COMPRISING SAID COMPONENT

20230134706 · 2023-05-04

    Inventors

    Cpc classification

    International classification

    Abstract

    Component (1) for endosseous screw, provided with a main body (10) which supports electronics (2) comprising at least one signal emission circuit and at least one sensor for acquiring one or more biophysical parameters of a patient, said component (1) being associable with an endosseous screw.

    Claims

    1. A component for endosseous screw, provided with a main body which supports electronics comprising at least one signal emission circuit and at least one sensor for acquiring one or more biophysical parameters of a patient, said component being associable with an endosseous screw, said signal emission circuit being arranged to send at least one signal relating to the one or more biophysical parameters acquired by the at least one sensor.

    2. The component according to claim 1, wherein said signal emission circuit is an RFID transponder circuit.

    3. The component according to claim 1, wherein the main body comprises a distal portion and a proximal portion which are both conductive separated by a dielectric intermediate portion, said electronics being electrically connected to both said distal portion and said proximal portion.

    4. The component according to claim 3, wherein said electronics comprises at least one integrated circuit arranged on a conductive bridge which connects said distal portion to said proximal portion.

    5. The component according to claim 4, wherein the signal emission circuit and the at least one sensor are formed on said integrated circuit.

    6. The component according to claim 4, wherein said integrated circuit and said conductive bridge are housed in a side recess of said intermediate portion.

    7. The component according to claim 3, wherein said main body is monolithic and made of a dielectric material, the distal and proximal portions being made conductive by a metallization or metal deposition process on the surface of said dielectric material.

    8. The component according to claim 3, wherein said main body is composed by said distal and proximal portions of a conductive material assembled at the two opposite ends of the intermediate portion of a dielectric material.

    9. The component according to claim 1, comprising an attachment portion for coupling with an endosseous screw, said attachment portion extending in a proximal position with respect to the main body.

    10. The component according to claim 9, wherein said attachment portion comprises a cylindrical stem provided with an outer thread arranged to couple with the endosseous screw.

    11. The component according to claim 1, wherein the one or more biophysical parameters acquired by the at least one sensor comprises at least one local temperature and/or pH of the patient, and they represent an indicator of possible infections at the implanted endosseous screw.

    12. A screw assembly comprising an endosseous screw comprising a tip, a stem and a head and at least one component according to claim 1 coupled to said head.

    13. A screw assembly according to claim 12, wherein said endosseous screw is at least partially made of a conductive material and it defines, together with the component, an antenna for the signal emission circuit.

    14. A screw assembly according to claim 12, wherein said endosseous screw is arranged to treat bone collapses or deformations, said tip and said head being both threaded, said stem being unthreaded.

    15. A monitoring system comprising a screw assembly according to claim 12 and at least one receiving reader arranged to acquire a signal coming from the signal emission circuit defined by the screw assembly, said signal comprising at least data relating to the one or more biophysical parameters acquired by the at least one sensor.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0051] FIG. 1 represents a perspective view of a first embodiment of a sensored component according to the present invention;

    [0052] FIG. 2 represents a side view sectioned along a transversal plane of the component in FIG. 1;

    [0053] FIG. 3 represents a perspective view of a second embodiment of a sensored component according to the present invention;

    [0054] FIG. 4 represents a side view of the component of FIG. 3;

    [0055] FIG. 5 represents a side view sectioned along a transversal plane of the component of FIG. 3;

    [0056] FIG. 6 represents an exploded side view of the component of FIG. 3;

    [0057] FIG. 7 represents an exploded perspective view of the component of FIG. 3;

    [0058] FIG. 8 shows a perspective view of an endosseous screw according to the present invention, provided with the component of FIG. 1, comprised in a fixation system and implanted on a patient's bone site;

    [0059] FIG. 9 shows an enlarged detail of FIG. 8;

    [0060] FIG. 10 represents a perspective view of a third embodiment of a sensored component according to the present invention;

    [0061] FIG. 11 represents a side view sectioned along a transversal plane of the component in FIG. 10;

    [0062] FIG. 12 represents a perspective view of a fourth embodiment of a sensored component according to the present invention;

    [0063] FIG. 13 represents a side view sectioned along a transversal plane of the component of FIG. 12;

    [0064] FIG. 14 represents an exploded perspective view of the component of FIG. 12;

    [0065] FIG. 15 shows a perspective view of an endosseous screw according to the present invention, provided with the component of FIG. 10, comprised in a fixation system and implanted on a patient's bone site;

    [0066] FIG. 16 shows an enlarged detail of FIG. 15;

    [0067] FIG. 17 schematically represents a monitoring system according to the present invention.

    DETAILED DESCRIPTION

    [0068] With reference to the enclosed FIGS. 1 and 2, reference number 1 identifies a first embodiment of a sensored component according to the present invention.

    [0069] The component 1 comprises a cylindrical-shaped main body 10 from which an attachment portion 11 provided with an outer thread 7 extends.

    [0070] The component 1 is crossed by a central hexagonal recess 8 which allows inserting a screwing tool, in particular an Allen wrench.

    [0071] The main body 10 is made of a dielectric material; two opposite distal 3 and proximal 4 portions are however made conductive by a metallization or metal deposition process on the outer surface. Instead, an intermediate portion 5 is kept insulating. The metallization of the proximal portion 4 extends up to the outer thread 7.

    [0072] The thickness of the intermediate portion 5, given by way of non-limiting example, is 4 mm.

    [0073] The dielectric material may be PVC, PMMA, PEEK, or still another material.

    [0074] The electronics 2 is arranged in a recess 6 formed at the intermediate portion 5, said electronics 2 being made of an integrated circuit 20 and of an antenna tuning inductor 21 arranged in series on a conductor bridge 22 that joins the distal portion 3 to the proximal portion 4.

    [0075] The integrated circuit 20 comprises therein an RFID transponder circuit and an adaptation circuit that allows tuning the component itself to the different RFID UHF working frequencies and to the different morphologies of the patient. The RFID transponder circuit defines an RFID transponder together with the antenna, defined by the component 1 coupled to an endosseous screw 100.

    [0076] The integrated circuit 20 still comprises therein sensors for measuring the patient's temperature T and pH P at the endosseous screw 100. Said measures are sent through the RFID transponder to an RFID reader 200, further described in greater detail hereinafter, in order to carry out an early diagnosis of infections due to the implantation of the endosseous screw 100.

    [0077] With reference to the enclosed FIGS. 3-7, reference number 1′ identifies a second embodiment of a sensored component according to the present invention.

    [0078] The second embodiment differs from the first one in that the main body 10′ is not monolithic, but made of a distal portion 3′, an intermediate portion 5′ and a proximal portion 4′, which are distinct and snap fitted together. In particular, the assembling occurs through forced coupling of two pins 9 integral with the distal portion 3′ and the intermediate portion 5′ with as many holes formed in the intermediate portion 5′ and in the proximal portion 4′.

    [0079] The distal portion 3′ and the proximal portion 4′ are integrally made of a conductive material, whereas the intermediate portion 5′ is made of a dielectric material. The attachment portion 11′ is made integral with the distal portion 4′, namely also made of a conductive material.

    [0080] The second embodiment differs from the first one also in that the central hexagonal recess 8 is replaced by two smooth holes 8′, which are axial and parallel but away from the axis of the main body 10′. The smooth holes 8′ are used, in analogy to the hexagonal recess, for inserting a two-tipped screwing tool.

    [0081] FIGS. 8 and 15 show an endosseous screw system 400 implanted on an anatomical site of the patient for the plantar arch reconstruction of a patient. Each of the bone screws 100, 101 has a threaded tip 102, a non-threaded stem 103 and a head 104, which is also threaded.

    [0082] As visible in FIG. 9, the component 1 is screwed into the head 104 of one of the endosseous screws 100 of larger diameter.

    [0083] With reference to the enclosed FIGS. 10 and 11, reference number 1″ identified a third embodiment of a sensored component according to the present invention.

    [0084] The third embodiment is substantially identical to the first one, except that, as visible in FIG. 16, it has a smaller diameter and as a result it is arranged to couple to one of the endosseous screws 101 of smaller diameter of the fixing system 400 made of a plurality of bone screws.

    [0085] With reference to the enclosed FIGS. 12-14, reference number 1′″ identifies a fourth embodiment of a sensored component according to the present invention.

    [0086] The fourth embodiment is substantially identical to the second one; however, it has a smaller diameter and as a result it is arranged to couple to one of the endosseous screws 101 of smaller diameter of the bone screw system 400.

    [0087] With reference to the enclosed FIG. 17, reference number 1000 identifies a monitoring system according to the present invention.

    [0088] On the one side, the system comprises a sensored screw assembly 150, made of an endosseous screw 100 provided with the previously described sensored component 1.

    [0089] The system still includes an RFID 200 reader, provided with a wrist strap or otherwise wearable by the user. The RFID reader 200 is arranged to query the transponder RFID of the sensored screw 150, in particular obtaining the following data: [0090] a unique identification of the user; [0091] data relating to the endosseous screw (model, size, implantation date and position); [0092] a degree of strength of the coupling between the receiving reader and the endosseous screw; [0093] local temperature T and/or pH P, acquired in real time.

    [0094] Moreover, the RFID reader 200 is able to connect, for instance through Bluetooth technology, to a mobile device 300 on which a proper application for viewing the above data received from the reader is installed.

    [0095] Moreover, the receiving reader may store data and send alarms should warning thresholds for temperature T and pH P be exceeded.

    [0096] An advantage of the invention lies in the fact that the sensored implant is applied to normal endosseous screws. Therefore, the same screw may be implanted with or without sensored component, depending on the specific needs and operative choices.

    [0097] A further advantage derives from the extreme simplicity of the assembling procedure of the sensored component by screwing it onto the screw head. The presence of a coupling element for a clamping tool further favors said assembly, which may be performed by the surgeon even in the intra-operative phase.

    [0098] Another advantage of the present invention is the use of the stem of the endosseous screw as a radiating antenna by the sensored component. In this way, a good signal communication to the external reader is achieved without resorting to a redesign of the system.

    [0099] Still another advantage lies in the fact that the sensored component is provided with a suitable adaptation circuit that easily allows tuning the device to the different UGF RFID working frequencies and to the different morphologies of the patient.

    [0100] Still another advantage derives from the use of an RFID transponder, which allows the signal transmission even without using internal batteries which would limit the useful life of the device.

    [0101] Obviously, a person skilled in the art, in order to satisfy contingent and specific requirements, may make numerous modifications and variations to the invention, all of them by the way included in the scope of protection of the invention as defined by the following claims.