Insert assembly with radio frequency identifier for medical device

Abstract

The following describes an insertion component 1 with a radio frequency identifier, which is adapted to be inserted into a medical device handpiece (4). The insertion component 1 includes an insert 2, a ferromagnetic layer 6, a dielectric layer 7, an insert antenna 8, and an identification chip 10. The insert 2 is adapted to interact with a part of the patient's body and includes at least one insert metal shank 5. The ferromagnetic layer 6 is arranged to contact the above-mentioned metal shank 5 of the insert. The ferromagnetic layer includes a ferromagnetic material. The dielectric layer 7 is arranged to contact the ferromagnetic layer 6. The insert antenna 8 is arranged to contact the above-mentioned dielectric layer 7 and includes an insert antenna metal element 9, which extends along a predetermined substantially planar profile P. The insert antenna 8 is configured to receive and transmit modulated or unmodulated electromagnetic fields within a predetermined frequency range. The identification chip 10 is operably connected to the insert antenna 8 and is configured to transmit information about the insertion component 1 when activated. The ferromagnetic layer 6 is adapted to reduce or eliminate the phenomena of attenuation and / or distortion of the electromagnetic field caused by field parasitics in the vicinity of the insert antenna 8, caused by the interaction of the transmitted / received electromagnetic field with the metal parts of the insert metal tang 5, and / or with the liquid present in the insert, and / or with the insert antenna metal element 9. The above-mentioned ferromagnetic layer 6, dielectric layer 7 and insert antenna 8 form a transceiver device 11 that enables the identification chip 10 to communicate with the handpiece antenna 12 of the handpiece 4, in which the insertion assembly 1 is adapted to be inserted.

Description

Technical Field

[0001] The present invention relates to an insertion assembly with a radio frequency identifier for a medical device.

[0002] In particular, the present invention relates to an insert assembly comprising an insert and a radio frequency identifier, the insert assembly being adapted to be inserted into a medical device handpiece, wherein the insert is adapted to interact with a portion of a patient's body.

[0003] Furthermore, the present invention relates to a handpiece assembly for an ultrasonic piezoelectric device, the handpiece assembly being adapted to identify an inserter by using a miniaturized radio frequency identifier.

[0004] Furthermore, the present invention relates to the context of ultrasound systems which are particularly and advantageously used in the medical surgical fields (e.g. neurospinal, craniofacial, orthopedic, otolaryngology), dental, surgical and non-surgical fields (e.g. oral surgery, implants, dental hygiene, and prevention, etc.), but according to other embodiments may also be used in the industrial or construction fields.

[0005] More precisely, such a system may be used in fields where it is necessary to perform removal, abrasion, cutting or drilling of material (eg mineralized material).

[0006] In the following, the present application will be meant to be applied in the medical surgical field (e.g. neurospinal, craniofacial, orthopedic, otolaryngology), dental, surgical and non-surgical fields (e.g. in oral surgery, implants, dental hygiene, and prevention, etc.), but according to other embodiments, it can also be used in the industrial or construction fields, in fields where it is necessary to perform the removal, abrasion, cutting or drilling of materials (e.g. mineralized types such as bone, enamel, dentin, tartar and biofilm). Background Art

[0007] In the medical or dental fields, and in particular in the fields of surgery or implantology, power ultrasound is applied in the dissection of hard tissue (bone) and soft tissue, in the cauterization of blood vessels and in the field of dental prevention for the removal of dental plaque.

[0008] Referring merely by way of example to the field of implantology, the site for inserting screws or other fixation systems into bones is prepared by using rotary tools of the type described above, however, these rotary tools have severe limitations both for the operator during surgery and for the patient after surgery.

[0009] Conventional instruments are problematic when operating on surgical sites where complex anatomy exists with difficult or limited surgical access, or in proximity to delicate anatomy such as nerves and blood vessels, to name a few.

[0010] The large amount of mechanical energy generated by the rotation and the considerable pressure that the operator must apply to the instrument result in potential damage to non-mineralized structures, significant heat generation, losses due to friction, and consequent overheating, and operator fatigue at the expense of the required intra-operative precision and control.

[0011] The background of the invention relates to ultrasonic power systems for medical and dental applications such as, for example, oral implantology. However, the invention is equally applicable to other areas of the medical and industrial fields.

[0012] The operation of most ultrasonic power systems is based on the transmission of longitudinal waves in the application device. Such waves are generated by a piezoelectric transducer and delivered to the device through a concentrator or waveguide called an ultrasonic horn.

[0013] However, there are some applications that use flexural, torsional or combined vibrations. For example, in the dental field, the longitudinal vibrations excited in an ultrasonic transducer are converted into flexural oscillations by an asymmetrically shaped tip or insert. The incorporation of one or more curves in the insert profile has a dual purpose, namely, to allow good access to the interior of the oral cavity and to convert the longitudinal motion of the transducer into linear flexural vibrations near the operative portion of the insert.

[0014] In ultrasonic ablators, the flexing motion of a hook-shaped insert is often used to remove calcified deposits (tartar) from teeth. In ultrasonic scalpels (such as the "Piezo Surgical Device" from Meshem SpA), the lateral motion produced in a long-handled sickle-shaped insert is used to precisely dissect mandibular bone and other mineralized tissue.

[0015] There are also ultrasonic ablators that remove plaque by linear and elliptical oscillations (as described in DE102005044074A1 or EP2057960B1). In these systems, a vibrating motion with bidirectional components is generated in the insert by flexural vibrations of the sensor in orthogonal planes, see in particular EP2057960B1. The configuration of these flexural transducers is related to previously disclosed concepts in which lateral oscillations are induced by radially and axially inserted adjacent piezoelectrics with opposite polarizations [see Mori, E et al., "New Bolt Clamped Flexural Mode Ultrasonic High Power Transducerwith One-Dimensional Construction", Ultrasonics International 89 Conference Proceedings; Watanabe, Y. et al., "A Study on a New Flexural-mode Transducer-solidHorn System and its Application to Ultrasonic Plastic Welding", Ultrasonics Vol. 34, 1996, pp. 235-238; Yun, CH. et al.; "A High Power Ultrasonic Linear Motor usinga Longitudinal and Bending Hybrid Bolt-Clamped Langevin Type Transducer", Jpn. J. Appl. Phys., Vol. 40, 2001, pp. 3773-3776].

[0016] During maxillofacial surgery, ultrasonic vibrations of the insert are often used to cut bone tissue.

[0017] According to dental implantology protocol, once a first hole of reduced size has been obtained, it is gradually enlarged using rotating drill bits of increasing cross-section until it reaches a diameter matching that of the implant.

[0018] The inserts typically used in ultrasonic systems for procedures performed in the oral cavity have an oscillation amplitude that is insufficient for all stages of implant site preparation. Such a limitation is inherent in the design of these devices, where, using the same handpiece, the larger the cross-section of the insert, the smaller the amplitude of the vibrations produced. This inverse relationship between the cross-section of the insert and the oscillation is a limitation on the applicability of the technology, especially in oral implantology, where a borehole of several millimeters in diameter is required.

[0019] There is another problem associated with the linear vibration of the insert, which does not allow perforation of the mandibular tissue unless manual oscillation of the handpiece is used in combination therewith. This auxiliary movement is indeed difficult to generate by the operator in the oral cavity and in any case is not very compatible with the precision requirements required by current clinical implantability practice.

[0020] Ultrasonic devices known from US73744552B2, US6402769B1, US2009 / 236938A1, US2011 / 0278988A1 are adapted to dissect biological tissue by exciting torsional or combined torsional and longitudinal ultrasonic vibrations. The common feature of these devices is that they all have a single geometrical deployment axis, and they are essentially axially symmetrical systems. In maxillofacial applications, such as dental implantology, the oscillating inserts used in the oral cavity have a deployment that is significantly asymmetric relative to the sensor axis. Therefore, in these fields, following the teachings of the above-mentioned inventions, it is impossible to generate torsional or longitudinal and torsional vibrations in the operating part of the insert (only valid for systems in which the transducer and the operating part are coaxial).

[0021] Slipszenko (US2013 / 0253559A1) invented an ultrasonic system configuration in which torsion, flexure or longitudinal vibrations are alternately generated in an ultrasonic scalpel for the treatment of soft tissues with an expansion axis perpendicular to the transducer expansion axis. According to this solution, the lateral vibration of the piezoelectric transducer can be converted into torsion, flexure or longitudinal oscillations by combining an ultrasonic horn or waveguide mounted eccentrically relative to the transducer axis. In order to correctly transmit the vibrations, the diameter of the back of the horn must be greater than the diameter of the transducer. Although it is possible to generate an alternating series of vibrations in orthogonal planes, the specific requirements of compactness, ergonomics and weight of dental and medical equipment cannot be achieved by applying Slipszenko's solution. The large size and eccentric mounting of the ultrasonic horn will significantly limit visibility within the oral cavity. In addition, in Sipszenko's solution, one or more waveguides are inserted between the scalpel and the conversion / vibration transmission horn to transmit sufficient vibrations. Even if the number of these components were reduced to a minimum, the overall length of the device would still not be compatible with use in small, narrow, and delicate spaces, such as in the oral or maxillofacial area or within the neurospinal or cranial cavities.

[0022] Mishiro (JPH0373207A) proposes an ultrasonic system for removing material, which in theory can find applicability in dental applications. The proposed solution is based on the typical operating principle of an ultrasonic motor, in which the elliptical vibrations generated in the joint formed by an ultrasonic transducer coupled to a waveguide produce a rotation of an operating tool that is kept in contact with the tip of the waveguide. In the configuration disclosed in JPH0373207A, the operating tool (whose axis of symmetry may be perpendicular or parallel to the axis of symmetry of the transducer) oscillates ultrasonically in addition to rotating, thereby allowing the removal of material. The contact point between the operating tool and the waveguide (through which the oscillating motion is transmitted) is generated by rotation and corresponds to the antinodes of the longitudinal and transverse vibrations generated in the joint of the transducer-waveguide. According to the configuration described in the solution, the operating element is supported by two pads positioned at the same number of fixed nodes generated along the oscillating element. Such a solution appears to be complicated in its application mode and is not suitable for applications in which the operating tool (insert) must be used and continuously replaced (such as in dental implantology).

[0023] Furthermore, in the field of biomedicine or medical instrumentation, the need for continuous improvement in patient safety is strongly felt.

[0024] For this reason, it is necessary to ensure that inserts for biomedical instruments (e.g., insert tips adapted to operate on a patient's teeth in medical devices for dental use, or inserts operating on bone, for example, in instruments used for surgical procedures in areas such as the maxillofacial or neuro-spinal or cranial or orthopedic areas) always operate correctly and safely, come from reliable manufacturers, are of the correct type of medical device, are not overused, etc.

[0025] For this purpose, it is very important that the inserter is equipped with an identifier capable of providing information about the inserter and its operation to the control unit of the medical device.

[0026] For this purpose, inserts are known which are provided with an RFID identifier and which are adapted to communicate wirelessly with the rest of the medical device.

[0027] Solutions of this type are described, for example, in WO 2006082340, US 2011087605 A1, US 2015147718 A1, US 2009047624 A1, US 2008044790 A1, US 2009065565 A1, US 2015150647 A1.

[0028] However, due to the specific characteristics of the inserts used in the field, in particular their very small size and the presence of metal elements forming the insert body, the communication performance offered by these known solutions is not satisfactory in terms of requirements or has not currently found application for users.

[0029] More specifically, the micro-antenna arranged in the insert to ensure wireless communication of the RFID identifier with the rest of the medical device (ie for energizing the RFID identifier) ​​acts like an inductor.

[0030] However, such inductance is disturbed by the presence of the metal of the insert body and also by possible liquids that may be present in the insert (for example, physiological solutions that are saline in nature), which act as antagonists of the electromagnetic fields since they tend to absorb these fields and, in the case of metal, to re-emit them symmetrically, causing their cancellation in the boundary areas of the metal.

[0031] In summary, the overall result of this phenomenon is a strong attenuation or even elimination of the signal carried by the electromagnetic field near the insert antenna, which deteriorates the communication performance between the RFID identifier and the rest of the medical device or even prevents such communication from occurring. This situation actually suppresses the advantages of the RFID identifier.

[0032] Another disadvantage of the above-mentioned known solution of an insert with an RFID identifier is that it is difficult to design an insert antenna operating at the frequencies required for UHF RFID communication, depending on the different intended standards for this type of communication in various countries.

[0033] In summary, there remains an unmet need for a medical device insert provided with an identifier adapted to support efficient and reliable communication with the rest of the medical device.

[0034] Furthermore, it must be considered that these inserts must be interchangeably connected to the ultrasound generator and that for reuse they must be able to be separated from the handpiece and placed in an autoclave, resulting in repetitive and very stressful treatment cycles for any RFID reader connected thereto.

[0035] Therefore, the need remains strongly felt for an insert identification solution which is not only small in size and can therefore be adapted to the small distal portion of the handpiece (i.e. adapted to tight operating or intervention areas), but which at the same time is very resistant to the pressures applied by the autoclave or similar processing cycles used for its sterilization.

[0036] The previously mentioned need for the insert's RFID reader to communicate wirelessly with the rest of the medical device places additional demands on the medical device handpiece. Such a handpiece must be provided with a radio frequency antenna that must be properly powered.

[0037] The reading antenna located inside the handpiece must meet very strict size and operation requirements. The size of the antenna must be miniaturized so that the antenna can be contained in the handpiece. This suggests the use of a loop antenna or a coil antenna.

[0038] However, there are several problems with small loop antennas or coil antennas. One of the main problems is due to the fact that, depending on the operating frequency and the geometry, the current circulating in the antenna loop tends to have so-called gaps (i.e. points where the current undergoes a phase reversal). This phenomenon means that the antenna emission is zero at certain points because the current is zero, and also leads to other low emission points where the phase current is opposite to the primary current. Ultimately, this significantly deteriorates the transmission performance of the antenna.

[0039] A further fundamental requirement is to minimize energy losses and line reflections due to ambient electromagnetic stray events, which stems from the need to ensure that the antenna impedance in the UHF frequency range is adapted to the generator in the medical device, which is not easy to achieve within this application range due to the small size of the antenna and the available space.

[0040] Finally, there arises a need to transmit RF signals inside the handpiece in order to power the handpiece antenna under impedance matching conditions and without an RF connector.

[0041] Therefore, the further need for an efficient radio frequency signal transceiver solution in a handpiece to allow efficient wireless communication with an insert radio frequency identifier remains strongly felt and currently unmet.

[0042] German patent application DE 102 04 884 A1 describes a "tag with transponder" or "RFID tag" which is equipped with a miniaturized oscillating circuit and an antenna, is not associated with use on medical devices, and operates at a frequency of 13.56 MHz. Summary of the invention

[0043] The object of the present invention is to provide a medical device insertion assembly allowing to solve the drawbacks described above with reference to the background art and respond to the above-mentioned needs particularly felt in the considered technical field.

[0044] Another object of the present invention is to provide a medical device comprising the aforementioned insertion assembly.

[0045] Some of the main advantages arising from the present invention are the following.

[0046] The location, thickness and type of material allows for minimizing the increase in the diameter of the insert without obstructing the clinician's view of the surgical site, thus ensuring and maintaining patient safety;

[0047] The small size and light weight (less than 15 grams) of the material and RFID chip (i.e., the material added to the metal of the insert) do not significantly affect the mechanical properties of the ultrasonic transducer when it is mechanically connected to the insert, thus keeping the operating parameters (such as the ultrasonic frequency, amplitude and power of the device) unchanged, always ensuring maximum performance and safety of the medical device.

[0048] The material and location of the RFID chip on the insert, the small size and weight prevent degradation and ensure that the insert maintains its life, efficiency and effectiveness.

[0049] The location and small increase in the insert diameter do not affect the simplicity of mechanical coupling between the insert and the transducer via a torque wrench or instrumentation based on force measurement methods.

[0050] The type of RFID system material on the insert is suitable for the temperatures used in sterilization processes, such as autoclaves and / or instrument cleaners.

[0051] The type of RFID coating material on the insert that interfaces with the patient interface is biocompatible.

[0052] The low number of layers of the RFID system on the insert ensures a simple production process, providing a system that is always efficient.

[0053] The reduced thickness of the RFID system and the resulting minimal increase in the diameter of the insert ensures that there is no sufficient concentric area around the components of the handpiece, ensuring that deflection caused by production process tolerances or excessive pressure applied by the clinician during surgery could cause the mechanical portions of the transducer to come into contact with the insert, thereby causing changes in the operating parameters of the device.

[0054] The insert is identified by a unique, non-writable code on the RFID insert chip.

[0055] The handpiece or handpiece antenna is identified by a unique, non-writable code of the RFID handpiece chip.

[0056] Specifically, for patient safety, unique RFID identification combined with medical devices allows:

[0057] a. Secure traceability of the insert or handpiece throughout its life cycle

[0058] b. Indicate to the clinician that the insert and handpiece are appropriate and compatible

[0059] c. Indicate to the clinician that the selected insert is appropriate and suitable for the selected intervention type

[0060] d. Indicate to the clinician the performance of the insert after current and past usage patterns and duration have been assessed

[0061] e. Instruct clinicians on the appropriate settings of the medical device regarding the insert in use

[0062] f. Clinical protocols and instructions for each procedure

[0063] g. Predictive maintenance

[0064] h. Regular maintenance

[0065] i. Share data with manufacturers for statistics and continuous improvement of products and their usage status

[0066] j. Sharing data with manufacturers to update medical devices and possible integration of new products or usage models for improving the efficiency and effectiveness of medical systems with inserts

[0067] k. Share data with universities, training centers, etc.

[0068] 1. Write the medical record, and in particular, write the history of the inserts used for the patient's treatment.

[0069] The entire RFID system (the inserter and distal antenna handpiece location as well as the handpiece and cables connecting the medical device to the handpiece) is easily cleaned and sterilized according to common clinical protocols.

[0070] In some embodiments, the antenna handpiece may be removed for maintenance and for cleaning and sterilization.

[0071] The data transmission channel of the RFID system, when present, shares the connection used to illuminate the handpiece cone in a distal position, with the benefit of not adding possible anomalies due to more connections and wires, and maintaining the flexibility of the cable connecting the medical device to the handpiece.

[0072] The invention thus provides a general solution which can be applied in dental surgery and prophylaxis or maxillofacial surgery or orthopedics or neuro-spinal or otolaryngology or craniofacial surgery, as well as other fields in the medical and industrial fields. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] Further features and advantages of the handpiece for a medical device according to the invention will emerge from the following description of a preferred embodiment given by way of indicative non-limiting example, with reference to the accompanying drawings, in which:

[0074] -Figure 1 A schematic diagram of an assembly of a medical device comprising an ultrasound system with an excitation handpiece and an interchangeable insertion assembly (e.g., for use in dentistry or microsurgery) is shown;

[0075] - Figure 2 Shown along Figure 1 The line II-II is intercepted Figure 1 A cross-sectional view of details of the handheld assembly and the insert assembly, in Figure 2 Components of the handpiece, such as a transducer (e.g., a piezoelectric transducer), are highlighted;

[0076] - Figure 3 Shows Figure 1 Axonometric view of multiple parts of the handheld assembly and some components of the insert assembly separated, in Figure 3 An insertion assembly, a handpiece distal portion cover, a light guide with a light concentrator, a handpiece antenna supported by a handpiece antenna connection element, and such internal handpiece components (such as a piezoelectric transducer) are shown;

[0077] - Figure 4 An axonometric view of only the central portion of the handpiece is depicted, without depicting the distal portion cover and handpiece antenna, highlighting the transducer shaft inserter connection tang for secure interchangeable connection of the insertion assembly;

[0078] - Figure 5 An axonometric view of the insert assembly is depicted;

[0079] - Figure 6 Shows Figure 5 an isometric view of an isolated portion of an insert, in which the different layers of the RFID are highlighted;

[0080] - Figure 7 shows an enlarged plan view of an interposer antenna in an extended portion of its plan profile adapted to wrap around and surround or partially surround an interposer foot;

[0081] - Figure 8 an axonometric view depicting a detail of an interposer antenna to which an identification chip is connected so as to arrange said identification chip and its entire body to protrude only on one side of the plane of extension of said interposer antenna;

[0082] - Fig. 9 depicts an axonometric view of another embodiment of an interposer antenna connected to an identification chip;

[0083] - Fig.10 Describes in detail Fig. 9an axonometric view of a detail of an interposer antenna to which an identification chip is connected so as to arrange the identification chip and its entire body to protrude only on one side of the extension plane of the interposer antenna;

[0084] - Fig.11 an axonometric view depicting a detail of an insert antenna to which an identification chip is connected so that the identification chip and its entire body are arranged on the same body level as the insert antenna and only partially protrude or project beyond one side of the plane of extension of the insert antenna;

[0085] - Fig.12 shows a top view of the insertion assembly;

[0086] - Fig.13 Shown along Fig.12 The line XIII-XIII intercepts Fig.12 The insert section, Fig.13 The RFID is highlighted;

[0087] - Fig.14 Shows Fig.13 The enlargement indicated by XIV, in Fig.14 The RFID layer is highlighted;

[0088] - Fig.15 Shows Fig.14 an enlarged cross-sectional view of;

[0089] - Fig.16 depicts a detail of a cross section of an insert assembly according to another embodiment;

[0090] - Fig.17 an isometric view of an insert assembly depicting a separate handpiece antenna component along with components of a distal portion of the handpiece and various layers including different radio frequency identifiers associated with the insert;

[0091] - Fig.18 An example of an equivalent circuit of a series representation of an assembly consisting of an RFID identification chip and an interposer antenna is shown;

[0092] - Fig.19 Another example of an equivalent circuit of a parallel representation of components including an RFID identification chip and an interposer antenna is shown, and a connection model is also included;

[0093] - Fig. 20 A block diagram depicting an embodiment of an interposer antenna and an identification chip;

[0094] - Fig.21 A block diagram of a handpiece portion of a medical device including a handpiece antenna is shown;

[0095] - Fig. 22 A simplified block diagram showing the RF signal distribution pattern in a handpiece;

[0096] - Fig.23 shows a block diagram of a coaxial cable connection adapted to connect a handpiece to a medical system control unit;

[0097] - Fig.24 An equivalent circuit for an embodiment of a handset antenna is shown. DETAILED DESCRIPTION

[0098] The term "miniaturized" refers to devices or components having dimensions between 50 and 800 microns, preferably between 100 and 600 microns.

[0099] The term "medical device" refers to an electromechanical device in which a piezoelectric handpiece drives the mechanical movement of an ultrasonic frequency insert. These devices can be applied in several fields, of which the following are listed only as examples:

[0100] Medical: in particular, surgery in neurospine, craniomaxillofacial, orthopedics, otolaryngology, pediatrics;

[0101] • Dentistry, and in particular surgery, general dentistry, hygiene and prevention (particularly removal of tartar, plaque and biofilm).

[0102] The functions performed by the device on the bone or tooth are, for example:

[0103] Cutting;

[0104] ·perforation;

[0105] Removal;

[0106] ·erosion.

[0107] Functions performed by the device on calculus / plaque / biofilm are, for example:

[0108] Removal;

[0109] Disintegration.

[0110] exist Figure 1 In the figure, reference numeral 101 identifies the ultrasound system 101 as a whole, which includes a generator device 102 or a control element 21, which is operably connected to a transducer 25, which generates ultrasonic micro-vibrations, which generate vibrations in a connected insert 2.

[0111] Merely as an example, the ultrasound system 101 is a surgical or preventive device, such as a dental or medical device. According to other embodiments, the ultrasound system 101 is an industrial instrument.

[0112] In the following there is described an insertion assembly 1 with a radio frequency identifier 3. Such an insertion assembly 1 is adapted to be inserted into a handpiece 4 of a medical device.

[0113] According to its general embodiment, the interposer assembly 1 comprises an interposer 2 , a ferromagnetic layer 6 , a dielectric layer 7 , an interposer antenna 8 , and an identification chip 10 .

[0114] The inserter 2 is adapted to interact with a part of a patient's body and comprises at least one inserter metal tang 5 .

[0115] The ferromagnetic layer 6 is arranged in contact with or on a portion of the above-mentioned insert metal tang 5 of the insert 2 .

[0116] According to an embodiment, said ferromagnetic layer 6 is glued to said insert metal tang 5 of insert 2. According to a different embodiment, said ferromagnetic layer 6 is applied to said metal tang 5 by inserting a double-sided adhesive.

[0117] The ferromagnetic layer 6 includes a ferromagnetic material.

[0118] The dielectric layer 7 is arranged in contact with the above-mentioned ferromagnetic layer 6 .

[0119] The insert antenna 8 is arranged in contact with the above-mentioned dielectric layer 7 and comprises a metallic insert antenna element 9 extending along a predefined substantially planar profile P. The profile P as a whole at least partially wraps around the metallic tang 5 .

[0120] Such an interposer antenna 8 is configured to receive and transmit modulated or unmodulated electromagnetic fields within a given frequency range.

[0121] The identification chip 10 is operatively connected to the above-mentioned insert antenna 8 and is configured to transmit information related to the insert component 1 when activated.

[0122] The above-mentioned ferromagnetic layer 6 is adapted to reduce or eliminate the attenuation and / or distortion of the electromagnetic field caused by field parasitic effects near the insert antenna 8, which field parasitic effects are caused by the interaction of the transmitted / received electromagnetic field with the metal part of the insert metal tang 5 of the insert 2, and / or with the liquid present in the insert 2, and / or with the metal insert antenna element 9.

[0123] The above-mentioned ferromagnetic layer 6, dielectric layer 7, and inserter antenna 8 form a transceiver device 11 adapted to enable wireless communication of the identification chip 10 with a handpiece antenna 12 comprised in a handpiece 4 into which the insert assembly 1 is adapted to be inserted.

[0124] According to another embodiment, the insertion assembly 1 includes an insert 2 and a radio frequency identifier 3 .

[0125] The insertion assembly 1 is adapted to be inserted into a medical device handpiece 4 .

[0126] The insertion assembly 1 comprises:

[0127] - the inserter 2 is adapted to interact with a part of a patient's body, wherein the inserter 2 comprises an inserter metal tang 5;

[0128] - RFID 3.

[0129] The RFID comprises a ferromagnetic layer 6 arranged on the side of the insert metal tang 5 of the insert 2 , in other words in direct contact considering a layer of glue or double-sided adhesive interposed between the ferromagnetic layer 6 and the insert metal tang 5 .

[0130] The ferromagnetic layer 6 comprises a ferromagnetic material. In particular, the ferromagnetic layer 6 is adapted to reduce or eliminate attenuation and / or distortion phenomena of the electromagnetic field caused by field parasitics in the vicinity of the insert antenna 8, which are generated due to the interaction of the transmitted / received electromagnetic field with the metal parts of the metal insert tang 5 and / or with the liquid present in the insert and / or with the metal insert antenna element 9.

[0131] The radio frequency identifier further comprises a dielectric layer 7 which is arranged in contact with the ferromagnetic layer 6 .

[0132] The RFID further comprises the interposer antenna 8 arranged in contact with the dielectric layer 7 and comprises an interposer antenna metal element 9 extending along a predefined substantially planar profile P. The profile P as a whole at least partially wraps around the metal tang 5. For example, the profile P is located on a cylindrical surface.

[0133] The interposer antenna 8 is configured for receiving and transmitting modulated or non-modulated electromagnetic fields within a given frequency range.

[0134] The radio frequency identifier further includes an identification chip 10 .

[0135] The identification chip 10 is operatively connected to the insert antenna 8 and is configured to transmit information related to the insert component 1 when activated.

[0136] Furthermore, the medical device handpiece 4 comprises a handpiece antenna 12 .

[0137] The ferromagnetic layer 6, the dielectric layer 7 and the insert antenna 8 form a transceiver device 11 adapted to enable wireless communication of the identification chip 10 with the handpiece antenna 12 of the handpiece 4. According to an embodiment of the insert assembly 1, the dielectric layer 7 is distinct from the ferromagnetic layer 6. Furthermore, the dielectric layer 7 is inserted between the ferromagnetic layer 6 and the insert antenna 8 in order to electrically isolate the metallic insert antenna element 9 of the insert antenna with respect to the ferromagnetic material of the ferromagnetic layer 6.

[0138] Advantageously, the ferromagnetic layer 6 and / or the dielectric layer 7 comprises a chip holder 13 .

[0139] The identification chip 10 is operatively connected to the interposer antenna 8 in such a way as to avoid protruding from at least a first or outer side 14 of the substantially planar profile P of the metallic insert antenna element 9 of the interposer antenna 8 .

[0140] Furthermore, the identification chip 10 protrudes with its chip part 16 on the opposite side to the outer side 14 with respect to the substantially planar contour P and from the inner side 15 of the metallic insert antenna element 9 of the insert antenna 8 .

[0141] Advantageously, the protruding chip portion 16 is received in the chip holder 13, which makes the radio frequency identifier particularly compact and space-saving.

[0142] Furthermore, inserting the protruding chip portion 16 into the chip holder 13 further shields the identification chip 10, making it more robust against external electromagnetic interference, and also makes the assembly of the identification chip 10 and the insert antenna 8 mechanically more robust against external stresses and more thermally protected from thermal stresses, such as thermal stresses imposed by a sterilizing autoclave or an instrument cleaner.

[0143] According to an embodiment, said ferromagnetic layer 6, said dielectric layer 7 and said insert antenna 8 form a stack having dimensions ranging between 50 and 800 microns, preferably between 100 and 600 microns and adapted to be placed over an insert having a dimension transverse to its longitudinal extension (e.g. a radial dimension at one of its longitudinal extension axes) not exceeding 6400 microns. These values ​​refer to the thickness of the stack in a plane, and therefore they correspond to an increase in the radius of the insert 2, where, for example, the insert is cylindrical, while the radial dimension of the insert is the diameter of the metal of the insert 2, where, for example, the insert is cylindrical.

[0144] According to an embodiment, the thickness of the ferromagnetic layer 6 , ie the radial dimension relative to the longitudinal extension of the insert 2 , ranges between 20 and 400 microns, preferably between 50 and 300 microns.

[0145] According to an embodiment, an internal insulating layer 17 (eg a double-sided adhesive) is arranged internally with respect to the ferromagnetic layer 6 (ie between the interposer metal tang 5 and the ferromagnetic layer 6 ).

[0146] According to an embodiment, the dielectric layer 7 is made of a double-sided adhesive.

[0147] According to an embodiment, the interposer antenna 8 is made of aluminum.

[0148] According to one embodiment, the insert antenna 8 has a flat rectangular shape, and the size of each short side of the rectangular side is between 1 mm and 6 mm, preferably between 2 mm and 4 mm, and the size of each long side is between 10 mm and 30 mm, preferably between 12 mm and 25 mm, and the thickness of the insert antenna 8 is less than 50 microns.

[0149] According to an embodiment, the radio frequency identifier 3 further comprises an external insulating layer 18 which is arranged outside the ferromagnetic layer 6 , the dielectric layer 7 , the identification chip 10 and the interposer antenna 8 .

[0150] According to an embodiment, the radio frequency identifier 3 further comprises a protective layer 19 (for example biocompatible), which is arranged externally relative to the ferromagnetic layer 6 , the dielectric layer 7 , the identification chip 10 and the interposer antenna 8 .

[0151] According to an embodiment, the radio frequency identifier 3 further comprises a protective layer 19 (for example biocompatible) arranged externally with respect to the external insulating layer 18 .

[0152] According to one embodiment, the outer insulating layer 18 is made of PVC (polyvinyl chloride), or PET polyethylene terephthalate, or for example Made of polyamide.

[0153] According to an embodiment, the protective layer 19 is biocompatible, for example a coating or epoxy compound having one or more components.

[0154] According to an embodiment, the ferromagnetic layer 6 , the dielectric layer 7 and the interposer antenna 8 form a stack.

[0155] According to an embodiment, the ferromagnetic layer 6, the dielectric layer 7 and the interposer antenna 8 wrap the interposer metal tang 5, thereby forming a structure that is substantially concentric with the central metal element 5. The term "concentric" does not mean that the structure completely surrounds the central metal element, nor does it mean that the structure must be completely concentric therewith, but only means that the structure surrounds the inner metal element along a portion of the perimeter of the central metal element, for example, to allow a minimum extension of the interposer antenna around the perimeter of the interposer, the extension being adapted to the desired transceiver.

[0156] According to an embodiment, such ferromagnetic layer 6 comprises ferrite. According to an embodiment, said ferromagnetic layer 6 is made of a thin sintered ferrite or polymer substrate with high magnetic permeability, mixed with micron-sized magnetic powders dispersed throughout the material.

[0157] According to one embodiment, the ferromagnetic layer 6 and the identification chip 10 are RFID TAG chips.

[0158] According to one embodiment, the identification chip 10 has a parallelepiped shape, with a base dimension between 50 micrometers and 1200 micrometers, preferably between 100 micrometers and 1000 micrometers, and a thickness less than 300 micrometers.

[0159] According to one embodiment, the insertion assembly 1 is configured to operate in association with medical devices for dentistry (or preventive or implantable) and medical applications in the maxillofacial, or craniofacial, or neurospinal, or orthopedic, or other anatomical regions.

[0160] The invention further relates to a medical device 20 comprising a control element 21 , a medical device handpiece 4 provided with a handpiece antenna 12 for an RF transceiver and an insertion assembly 1 as described in any of the above embodiments.

[0161] According to an embodiment, the insertion assembly 1 is operatively, mechanically and detachably connected to the handpiece 4 .

[0162] According to one embodiment, the medical device handpiece 4 includes a handpiece distal portion 22, a handpiece central portion 23, and a handpiece proximal portion 24 terminating at a handpiece distal end 30. A transducer 25, such as a piezoelectric transducer, is connected to an ultrasonic generator or control unit 26. The transducer 25 is received in the medical device handpiece 4, and an insert attachment tang 27 protrudes through the handpiece distal portion 22, which is removably connected to the insert 2 to resonate the insert 2 when activated.

[0163] According to an embodiment, the handpiece distal portion 22 comprises the handpiece antenna 12. According to an embodiment, the handpiece antenna 12 is removably connected to the handpiece 4. According to an embodiment, the handpiece antenna 12 is contained in the handpiece 4 and is connected to the handpiece 4 in a fixed manner.

[0164] According to one embodiment, the handpiece distal portion 22 includes a handpiece antenna connection element 28 .

[0165] The handpiece antenna 12 is supported and electrically connected to the handpiece antenna connection element 28 and protrudes from the handpiece antenna connection element 28 toward the handpiece distal end 30 so as to at least partially overlap the insert antenna 8 when the insert is connected to the handpiece 4.

[0166] According to an embodiment, the handpiece antenna 12 protrudes from the handpiece antenna connection element 28 toward the handpiece distal end 30 so as not to overlap with the inserter antenna 8 when the inserter is connected to the handpiece 4 .

[0167] According to an embodiment, the handpiece antenna connection element 28 is electrically connected to the handpiece in a fixed or removable manner. The handpiece antenna connection element 28 may include at least one LED 29 .

[0168] According to an embodiment, the handpiece antenna connection element 28 does not include an LED 29 .

[0169] According to one embodiment, if the handpiece antenna connection element 28 includes at least one LED 29, it may include a light guiding element 31, which includes at least one light concentrator 32 associated with the handpiece antenna connection element 28 so as to guide the light of at least one LED 29 at the distal end 30 of the handpiece to illuminate the working area of ​​the medical device 20.

[0170] According to an embodiment, the optical waveguide element 31 , the handpiece antenna connection element 28 and the handpiece antenna 12 are covered by a handpiece distal part cover 33 , which is removably connected to the handpiece distal part 22 (eg made of aluminum).

[0171] According to an embodiment, the medical device 20 connects the handpiece 4 to the ultrasound generator or control unit 21 via a connection cable 34 for power and fluid supply.

[0172] According to one embodiment, the medical device handpiece 4 can interchangeably receive an insert 2 that is mechanically coupled to a device that generates ultrasonic microvibrations (e.g., a piezoelectric transducer 25) and operates at different frequency and power ranges and ultrasonic amplitudes depending on the selected type of insert 2.

[0173] According to an embodiment of the insert assembly, the insert antenna 8 is an RF antenna adapted to operate at radio frequencies, the identification chip 10 is a radio frequency identification chip and the above frequency ranges include one or more radio frequency ranges.

[0174] According to one embodiment of the insertion component 1, the above-mentioned transceiver device (hereinafter also referred to as "transceiver structure") formed by the ferromagnetic layer 6, the dielectric layer 7 and the insertion component antenna 8 can be modeled with the help of a circuit, the electrical parameters of the circuit depend on the size and material of the ferromagnetic layer 6.

[0175] According to an embodiment option, the above transceiver structure formed by the ferromagnetic layer 6, the dielectric layer 7, the insert antenna 8 and the identification chip 10 can be modeled by an LC circuit, wherein the inductance La parameter and the capacitance Cc parameter depend on the size and material of the ferromagnetic layer 6, the dielectric layer 7, the insert antenna 8 and the identification chip 10. In particular, the inductance La mainly depends on the size and material of the ferromagnetic layer, the dielectric layer and the insert antenna, while the capacitance Cc mainly depends on the identification chip 10.

[0176] In this case, the frequency range in which the transceiver structure can operate depends on the above-mentioned parameters of inductance La and capacitance Cc. In fact, in the absence of other elements in the LC circuit, the resonant frequency is obtained from the well-known formula f0=1 / [2π(LaCc)1 / 2].

[0177] It should be noted that the ferromagnetic layer contributes to the inductance value LA by electromagnetic coupling, but if the ferromagnetic layer is electrically isolated from the metal part of the interposer antenna, the ferromagnetic layer does not introduce another element in the equivalent circuit. On the contrary, if the ferromagnetic material is even only partially in contact with the metal part of the interposer antenna, the ferromagnetic layer introduces another equivalent element in the circuit model, corresponding to a voltage-dependent nonlinear impedance, thereby causing an undesirable and uncontrollable perturbation of the resonant frequency.

[0178] In this regard, the aforementioned embodiment is particularly advantageous, in which a dielectric layer 7 is inserted between the ferromagnetic layer 6 and the interposer antenna 8 so as to electrically isolate the metallic interposer antenna element 9 of the interposer antenna with respect to the ferromagnetic material of the ferromagnetic layer 6. In fact, thanks to this feature, problems caused by incomplete or completely isolated contacts between the ferromagnetic material and the metallic part of the antenna are eliminated, which problems can impair the stability, repeatability and efficiency characteristics of the transceiver system and make it impossible to guarantee a single and stable resonant frequency at the designed value.

[0179] In fact, the dielectric layer arranged in such a way as to separate the antenna from the ferromagnetic layer performs the function of isolating the resonant RFID system from external disturbances, thereby also ensuring its stability and reproducibility, and especially at high frequencies (mentioned below). Preferably, the resonant RFID system of the insertion component of the present invention is adapted to operate at high frequencies.

[0180] Depending on the usage option of the plug-in component, the operating frequency range of the transceiver structure includes the frequency range in the UHF RFID band (between 860 MHz and 960 MHz): for example, 865-868 MHz ETSI European technical standard, 902-928 MHz FCCFHSS North American technical standard, 916.7-920.9 MHz and 916.7-923.5 MHz MIC LBT Japanese technical standard, 902-907.5 MHz and 915-928 MHz ANATEL FHSS Brazilian technical standard, 920.5-924.5 MHz M11 FHSS Chinese technical standard.

[0181] According to an embodiment option of the insert assembly, the thickness of the ferromagnetic layer (ie relative to the radial dimension of the insert) ranges between 20 micrometers and 400 micrometers.

[0182] More preferably, the thickness of the ferromagnetic layer (ie relative to the radial dimension of the insert) is in the range between 50 micrometers and 300 micrometers.

[0183] According to different possible implementation options of the insert assembly, the ferromagnetic layer is made of a thin sintered ferrite or polymer matrix with high magnetic permeability, mixed with micron-sized magnetic powders dispersed throughout the material.

[0184] According to an embodiment of the insert component 1 , the identification chip 10 is an RFID chip (eg an RFID chip known per se).

[0185] According to an embodiment of the insertion assembly 1, the identification chip 10 is configured to store and transmit, when activated, via the above-mentioned transceiver structure, one or more information belonging to the following set:

[0186] - Unique and unchangeable identification code information of the inserted component;

[0187] - Information related to the manufacturer and traceability of the insertion component and / or the type or types of medical devices in which the insertion component may operate;

[0188] - information about the operating frequency range in which the transceiver structure of the inserted component can operate;

[0189] - information that the insert screwed onto the handpiece is suitable for the type of surgical procedure selected in the medical device;

[0190] - historical information about usage patterns and duration of usage;

[0191] - Information about the integrity of the inserted components to maximize efficiency and effectiveness for the patient during the clinical procedure phase;

[0192] - Information about the integrity of the insert components for proper periodic maintenance;

[0193] - information about whether the insert component, if inserted into the corresponding handpiece, has been correctly inserted;

[0194] - Information about operating parameters of the inserter tip assembly and / or error or warning messages in the presence of abnormal operating situations.

[0195] Depending on the use example, the insertion assembly is configured to operate in association with medical devices for dental (or preventive or implantable) and medical applications in the maxillofacial or craniofacial or neuro-spinal or orthopedic or other anatomical areas.

[0196] A medical device according to the invention is described herein.

[0197] The medical device comprises a control unit, a handpiece having a handpiece antenna, and an insertion component as described in any one of the above embodiments, wherein the insertion component is operably and mechanically connected to the above-mentioned handpiece of the medical device, and wherein the insertion component antenna is configured to wirelessly communicate with the handpiece antenna.

[0198] See also Figure 18-20 , further information about possible embodiments of the insertion assembly will be given below.

[0199] Fig.18 An equivalent circuit of a series representation of the components including the RFID identification chip 10 and the interposer antenna 8 is shown. Ignoring the overall parasitic capacitance, the identification chip 10 is modeled by a capacitor Cc and a resistor Rc; the interposer antenna 8 is modeled by an inductor La and a resistor Ra. In fact, the entire circuit is an LC circuit, and the resistance component takes into account the "non-ideal situation", that is, the radiation system loss and energy loss.

[0200] Such a model is an embodiment in which the wireless transceiver structure is based on near-field UHF technology (860 MHz÷960 MHz) and exploits the reactive part of the electromagnetic field, operating as a so-called "magnetic antenna" with a preferably segmented closed-loop geometry.

[0201] From a field point of view, the ferromagnetic layer has the function of isolating the wireless transceiver structure from the metal part of the insert body, thereby preventing the generation of reflected antagonistic fields caused by stray currents induced by the variable primary magnetic field, thereby avoiding the phenomenon of attenuation or nulling of the overall electromagnetic field.

[0202] In other words, the addition of a ferromagnetic layer with a complex effective permeability modifies the magnetic field distribution by affecting the mutual inductance and the self-inductance. By appropriately selecting the material and dimensions of the ferromagnetic layer (e.g., as in the above-described implementation options), one may have the freedom to optimize the design of the transceiver structure, maximize the strength of the total field present at the antenna, and improve communications as desired.

[0203] From a "lumped parameter" electrical point of view, the ferromagnetic layer determines the effect of increasing the inductance of the LC system (where C is dominated by the chip). This characteristic, in turn, determines the further effect of lowering the resonance frequency of the "antenna-chip" system, which has the advantage of bringing it within the limits required for the UHF band (and therefore facilitating and improving the design of the transceiver structure, making it more easily adapted to the desired use).

[0204] Fig.19 Another example of an equivalent circuit of a parallel representation of components including the RFID identification chip 10 and the interposer antenna 8 is shown, also including a model of the connection G. The description includes system parasitic elements, such as antenna parasitic capacitance.

[0205] In particular, in this case, the transceiver structure comprising the interposer antenna 8 and the ferromagnetic layer 6 is modeled by means of an RLC circuit, whereas the identification chip 10 is modeled using an RC circuit.

[0206] From a substantive perspective, the above Fig.18 The considerations already made apply.

[0207] Fig. 20 A block diagram of an embodiment of an interposer antenna 8 and an identification chip 10 is depicted.

[0208] In particular, the magnetic field lines are highlighted around the near-field antenna 8 .

[0209] In the present embodiment, the identification chip 10 comprises an analog front end (power management element 71 and modulator / demodulator element 72 ) and a digital control part having a controller 73 (of a type known per se, for example an RFID tag) and a non-volatile memory 74 .

[0210] As indicated in paragraph 52 (ìx-xx-xì), the non-volatile memory 74 is configured to store usage information, such as a cumulative total of usage time and a statistically estimated degree of wear, so as to provide the clinician with updates even when the insert is used in places other than the original (a clinician with several offices) but is always used with an appropriate and compatible medical device.

[0211] According to a particular implementation option, in order to ensure data integrity and authenticity, the data may also be stored in the non-volatile memory 74 after an encryption or cryptographic authentication process that can only be decrypted by the appropriate medical device associated with the insert.

[0212] The following describes a medical device handpiece assembly including a medical device handpiece 4. Such handpiece 4 includes a handpiece distal portion 22 adapted to receive, by insertion, an insertion assembly 1 (e.g., an insertion assembly according to the above-described embodiments), the insertion assembly 1 including a radio frequency identifier 3, an inserter antenna 8, and an inserter 2 adapted to interact with a portion of a patient's body.

[0213] The medical device handheld assembly further includes: a handheld antenna 12 disposed in the distal handheld portion 22 ; and a radio frequency signal supply device configured to provide the handheld antenna 12 with a radio frequency signal adapted to be transmitted by the handheld antenna 12 .

[0214] The handpiece antenna 12 is configured to wirelessly communicate with the inserter antenna 8 when the inserter assembly is inserted into the handpiece 4 in an insertion region R included in the handpiece distal portion 22 .

[0215] The handpiece antenna 12 is a single coil loop antenna, preferably a segmented loop antenna, comprising at least two handpiece antenna segments S1, S2 electrically arranged in series, which will be referred to as "first segment" S1 and "last segment" S2 hereinafter. The first end 41 of the first segment S1 of the at least two handpiece antenna segments is operably connected to the first end 51 of the RF signal supply device, and the second end 42 of the last segment S2 is operably connected to the second end 52 of the RF signal supply device to form a coil radiation structure around the insertion area R, the coil radiation structure being configured to generate an electromagnetic field having a radio frequency depending on the RF signal in such an insertion area R.

[0216] Each of the single coil loop or the at least two handpiece antenna sections (S1, S2) mentioned above comprises a radiating metal element (S11, S21) electrically connected in series to a capacitive element (S12, S22), the radiating metal element being characterized by a corresponding inductance L, the capacitive element having a capacitance C so as to compensate for the effect of the inductance L of the radiating metal element on the circulating current in the coil of the handpiece antenna 12 within the UHF RFID range (860MHz÷960Mhz).

[0217] According to an embodiment of the handheld assembly, the above-mentioned capacitance C of each capacitive element (S12, S22) further adapts the characteristic impedance of the handpiece antenna 12 to the RF generator placed in the control element 21 of the medical device 20, which is operably connected to the handheld assembly.

[0218] According to one embodiment of the above-mentioned handheld device, the above-mentioned handheld device antenna 12 also includes an input impedance adaptation first electrical network 43, which is included between the above-mentioned first end 51 and the second end 52 of the signal supply device and the above-mentioned first end of the first section 41 and the above-mentioned second end of the last section 42 of the handheld device antenna 12; and also includes an antenna impedance adaptation second electrical network 44, which is included in the segmented antenna loop and is electrically connected in series between the two sections (S1', S2') of the above-mentioned at least two handheld device antenna sections.

[0219] According to an implementation option, the input impedance adaptation first electrical network 43 comprises an LC inductor-capacitor circuit or a capacitor circuit.

[0220] According to one embodiment option, the above-mentioned antenna impedance adaptation second electrical network 44 includes an RC resistor-capacitor circuit or a capacitor circuit, which is configured to adapt the antenna impedance to a required impedance value and is adapted to optimize the transmission of radio frequency signals generated by the medical device 21 and carried along the cable 34 and the handpiece 4.

[0221] For example, such impedance values ​​in the UHF RFID range (860 MHz÷960 MHz) can be represented by a complex number Z=R+iX having a module between 20 and 80 ohms, preferably between 45 and 55 ohms.

[0222] According to one embodiment of the handpiece 4, the above-mentioned radiating metal elements (S11, S21) of the segmented loop antenna can be modeled by an equivalent circuit including an inductance L and a resistance R, wherein the inductance is between 2nH and 30nH, and preferably in the range between 4nH and 20nH.

[0223] By definition, LC=(ω 2) -1 And the above-mentioned capacitive elements (S12, S22) controlled by the resonant relationship of the system where ω=2πf and f is the working resonant frequency are capacitors with a capacitance between 1 pF and 12 pF, preferably between 2 pF and 10 pF.

[0224] According to an embodiment of the handpiece 4, the handpiece antenna 12 is configured to operate within a frequency range in the UHF RFID band between 860 MHz and 960 MHz.

[0225] According to an implementation option, all antenna sections are characterized by equal capacitance C and inductance L values.

[0226] According to another embodiment option, the inductance value L of the radiating metal element differs from segment to segment, and the capacitance value C of the capacitive element depending on the inductance value L of the respective segment differs from segment to segment.

[0227] According to an embodiment, the handheld assembly 4 further comprises a handpiece identifier 45 adapted to communicate with the handpiece antenna 12 wirelessly or by wire.

[0228] Such a handpiece identifier 45 is configured to provide handpiece antenna identification information and / or information related to the operating status and / or operating frequency of the handpiece antenna 12 .

[0229] According to an embodiment of the handheld component 4 , the RF signal supply device includes a signal guide 50 and a handheld component antenna connection element 28 .

[0230] According to a preferred embodiment, the signal guide comprises a microstrip printed circuit with an impedance of 50 ohms, which is configured to transmit the radio frequency power signal from the connecting cable 34 between the handpiece 4 and the control element 21 of the medical device 20 to the handpiece antenna 12 .

[0231] According to another embodiment, the signal guide 50 comprises a miniaturized coaxial cable with an impedance of 50 ohms.

[0232] The hand piece antenna connection element 28 connected to the signal guide 50 and the hand piece antenna 12 includes the first end 51 and the second end 52 of the RF signal supply device.

[0233] According to one embodiment, the microstrip circuit is a 50 ohm impedance controlled circuit including a metal trace having a thickness of less than one millimeter.

[0234] The above-mentioned microstrip circuit can be obtained by means of a multilayer printed circuit based on a technique known per se.

[0235] According to a particular embodiment option, the thickness of the above-mentioned microstrip circuit including the metal traces is between 0.2 mm and 1.0 mm, preferably between 0.35 mm and 0.85 mm, and the above-mentioned microstrip circuit is made of Vetronite material type FR4 or Kapton-Polyamide or Rogers.

[0236] According to an embodiment of the handheld assembly, the above-mentioned coil radiating structure of the handpiece antenna has a diameter less than 30 mm so as to be contained within the inner wall of the distal portion 22 of the handpiece.

[0237] According to an embodiment of the handheld assembly, the handpiece antenna 12 is connected to the handpiece distal portion 22 in a fixed or detachable manner.

[0238] According to a particular embodiment of the handheld assembly, the handpiece antenna 12 is made of a T-shaped or G-shaped flexible rigid multilayer printed circuit board, wherein a flexible portion (eg Kapton-polyamide) extends from a rigid portion (eg Vetronite type FR4 or Rogers).

[0239] When the above-mentioned flexible rigid multilayer printed circuit board is placed in the appropriate position inside the cone of the handpiece (for example, by welding or ultrasonic welding), the upper part of the T or Г is wrapped around the cone of the light guide, causing the edges of the upper part of the T or Г to overlap, thereby allowing electrical contact (i.e., forming a circle or segmented ring).

[0240] In this case, exactly in the junction of the vertical and horizontal segments of the T or Г, a TAG is placed, which is electrically connected via a decoupling capacitor. Such a TAG performs the function of the handpiece identifier described above, and performs the function of identifying the handpiece antenna cone, for example, for traceability purposes, for verifying the correct use relative to the geographical area (for example, according to the continent or country of destination, for example, Europe, the United States or Japan - it is necessary to adapt the handpiece antenna to the local operating frequency, which can be achieved by a set of specific antenna capacitors with appropriate values ​​adapted to the correct operating frequency), and for the insert to be compatible with the clinical application.

[0241] Reference Figure 21-24 , further information regarding possible embodiments of the medical device handheld assembly will be provided below.

[0242] Fig. 22 A simplified block diagram of the RF signal distribution mode in the handpiece is shown. In such a block diagram, a microstrip circuit 50 comprising a multi-layer flexible circuit in the above-mentioned embodiment is shown, which in turn comprises an impedance adaptation circuit on a printed circuit 53 and a corresponding RF 54 impedance adaptation network at each end of such circuit 53.

[0243] In this embodiment, the microstrip circuit 50 has the function of transmitting a composite signal including an RF signal for the handpiece antenna and a DC signal for the LED illumination circuit of the light cone with the lowest possible loss.

[0244] Microstrip or stripline circuits are an established technology in the field of controlled impedance printed circuit boards, where high integrity of high frequency signals is to be maintained. Moreover, such microstrip circuits have very small dimensions (particularly thickness) and are therefore adapted to the small internal space available in the handpiece. For example, the microstrip line is adapted to obtain a thickness ranging between 0.2÷1.0 mm, preferably between 0.35÷0.85 mm.

[0245] Upstream of the microstrip circuit (in Fig. 22 and 23 ), there is a minimum RF area connector 55 having a pin connection that is configured to connect to a corresponding minimum RF area connector 65 having a pin connection that interfaces with the coaxial cable 60.

[0246] This coaxial cable 60 ( Fig.23 ) connects the handpiece 4 to the control element 21 of the medical device and is used to transmit RF signals between the handpiece 4 and the control element 21.

[0247] return Fig. 22 , downstream of the microstrip circuit (at Fig. 22 and 21 ), there is another minimum RF area connector 55 having a pin connection, which is configured to be connected to a corresponding another minimum RF area connector 55 having a pin connection that interfaces with an RF-DC decoupling network (or decoupler) 56.

[0248] Indeed, in this case, in the flex-rigid circuit, an RF-DC decoupler 56 ( Fig.21 ), the RF-DC decoupler separates the RF component from the DC component and routes the DC component to the LED lighting circuit 57 of the light cone, and routes the RF component to the handpiece antenna 12.

[0249] The above-described minimum area RF connector 55 with pin connections is configured to minimize the insertion area (eg, minimize RF radiation losses at the interconnection point) and allow adequate transmission performance even in contexts where known RF connectors for coaxial cables cannot be used due to size reasons.

[0250] Fig.21Also shown are functional blocks corresponding to the illumination circuit 57 and optical signal guide DC 58 as well as the handpiece antenna 12 which is a near field antenna with RF input impedance adjustment 59 .

[0251] Fig.21 Also shown are functional blocks corresponding to the identifier (tag) of the handpiece 45 , which are connected in wireless near-field mode or in wired mode by means of decoupling the capacitor from the handpiece antenna 12 .

[0252] Fig.24 An equivalent circuit of a handset antenna according to an embodiment is shown.

[0253] In the following, a medical device 20 is described, which includes a control element 21, a medical device handpiece 4 described according to any of the above embodiments, and an insertion component 1, which includes a radio frequency identifier 3, an inserter antenna 8 and an inserter 2 adapted to interact with a part of a patient's body.

[0254] The insertion assembly 1 is operably and mechanically detachably connected to the handpiece 4 of the handheld assembly.

[0255] The inserter antenna 8 and the handset antenna 12 are configured to communicate wirelessly with each other in radio frequencies.

[0256] According to one embodiment, the medical device 20 is configured in such a way that when the insertion component 1 is connected to the handpiece 4, the insertion component antenna 8 is arranged near the handpiece antenna 4 in the above-mentioned insertion area R, and the radio frequency electromagnetic field generated by the handpiece antenna 4 exists in a radiating state in the insertion area R.

[0257] As can be noted, the objectives of the invention are fully achieved by the system chain (insertion assembly 1 - handheld assembly 22; 4; 24 - cable 34 - medical device 20 - control device 21) developed and described above and by means of its structural and functional characteristics.

[0258] Indeed, by virtue of the features described in detail above, the insertion assembly allows reducing and minimizing undesirable phenomena that deteriorate the communication between the insertion assembly and the rest of the medical device.

[0259] In particular, from a field point of view, the ferromagnetic layer has the function of isolating the wireless transceiver structure from the metallic parts of the insert itself, preventing the generation of reflected antagonistic fields and thus avoiding phenomena of attenuation or nulling of the overall electromagnetic field (complained in the prior art).

[0260] The addition of a ferromagnetic layer with a complex effective permeability modifies the magnetic field distribution by affecting the mutual inductance and self-inductance. By appropriately selecting the material and dimensions of the ferromagnetic layer (e.g., as in the above-described implementation options), one may have the freedom to optimize the design of the transceiver structure, maximizing the strength of the total field present at the antenna and improving communications as desired.

[0261] Ultimately, this leads to improvements in patient safety requirements, which are extremely important in the indicated technologies and application areas, but particularly in the dental and medical fields defined in the document.

[0262] From a "lumped parameter" electrical point of view, the ferromagnetic layer increases the inductance of the LC system (where C is the chip). This characteristic, in turn, determines the further effect of lowering the resonance frequency of the "antenna-chip" system, which has the further advantage of bringing it within the limits required for the UHF band and achieving further desired purposes, and therefore facilitating and improving the design of the transceiver structure, making it more easily adapted to the desired use.

[0263] With reference to the requirements of the handpiece antenna, it is noteworthy that the handpiece antenna has a very small size (adapted to the use context) by virtue of the functional and structural features described above, the handpiece antenna can be easily manufactured and provides sufficient transmission performance.

[0264] Indeed, by means of the loop or segmented loop structure and the positioning of the insertion area around the insertion component in the distal handpiece part, the handpiece antenna has a uniform transmission lobe over its entire transmission area and generates a stable and sufficiently strong electromagnetic field precisely in the insertion area of ​​the insertion component.

[0265] The segmented loop antenna structure comprises a plurality of line segments connected by capacitors which, by means of their capacitance, compensate and / or cancel the inductance of the corresponding copper line segments, avoiding phase reversal of the current circulating on the coil, thus obtaining a uniform and strong field in the area in which the insert antenna intended to communicate with the handpiece antenna is positioned, in particular in the center of the coil, ultimately allowing the unique insert identifier to be read and the operating parameters and maintenance parameters of the insert to be written to or read from a non-volatile memory.

[0266] The series configuration of capacitors connecting the line segments of the segmented loop antenna structure allows precise tuning of the resonant frequency, being able to rely on the overall capacitance achieved by multiple capacitors ensuring a fine resolution of the total capacitance value rather than on individual components with coarse tolerances and nominal values ​​imposed by the market.

[0267] Furthermore, the handpiece includes a communication circuit (handpiece antenna and associated RF signal supply) that allows adequate impedance adaptation (necessary for efficient RF signal transmission and emission) even in a small structure that does not allow the use of common impedance-adapted RF transmission methods (e.g., coaxial cables and associated RF connectors). This object is achieved, for example, by an impedance-adapted power supply network included in the segmented ring structure of the antenna and by a microstrip RF signal distribution circuit having the above-mentioned characteristics.

[0268] Those skilled in the art may make changes and adjustments to the embodiments of the above-described insertion assembly and medical system, or may replace components with other functionally equivalent components to meet possible needs without departing from the scope of the appended claims. All features described above belonging to possible embodiments may be implemented without considering the other embodiments described.

[0269] Reference Numbers List

[0270] 1 Insert component

[0271] 2 Insert

[0272] 3 RFID

[0273] 4 Medical equipment handpieces

[0274] 5 Insert metal tang

[0275] 6 Ferromagnetic layer

[0276] 7 Dielectric layer

[0277] 8 Insert antenna

[0278] 9 Insert antenna metal element

[0279] 10 Identification chip

[0280] 11 Transceiver equipment

[0281] 12 Handheld antenna

[0282] 13 Chip holder

[0283] 14. The outer side of the substantially planar profile of the metal insert antenna element of the insert antenna

[0284] 15 The inner side of the insert antenna metal element of the insert antenna

[0285] 16 Highlight the chip part

[0286] 17 Internal insulation layer, e.g. double-sided adhesive

[0287] 18 Outer insulation layer, e.g. PVC or PET or polyamide

[0288] 19 Biocompatible protective layer, such as coating or one-component or multi-component epoxy compound

[0289] 20 Medical equipment

[0290] 21 Control elements

[0291] 22 Handpiece distal part

[0292] 23 Handpiece center section

[0293] 24 Handpiece proximal part

[0294] 25 Transducer, such as a piezoelectric transducer

[0295] 26 Ultrasonic generator or control unit

[0296] 27 Threaded tang for insert attachment

[0297] 28 Handheld antenna connection element

[0298] 29LED

[0299] 30 Handpiece distal end

[0300] 31. Light guide element

[0301] 32 Concentrator

[0302] 33 Handpiece distal part cover

[0303] 34 Connection cables

[0304] 41 Handheld antenna first section first end

[0305] 42 The second end of the last section of the handheld antenna

[0306] 43 Handheld antenna input impedance adaptation first electrical network

[0307] 44 Handheld antenna - antenna impedance adaptation second electrical network

[0308] 45 Handheld device identifier

[0309] 50 Signal guide of the radio frequency signal supply device (for example, microstrip circuit)

[0310] 51 First end of the signal supply device

[0311] 52 second end of the signal providing device

[0312] 53 Impedance matching circuit on microstrip printed circuit board

[0313] 54 Microstrip Circuit RF Impedance Matching Network

[0314] 55 Minimum area RF connector with pin connection

[0315] 56RF-DC decoupling network (or decoupler)

[0316] 57 LED lighting circuit

[0317] 58 DC optical signal guide

[0318] 59 Handheld antenna input RF impedance matching network

[0319] 60 Coaxial connection cable between handpiece and control unit

[0320] 61 50 ohm RF coaxial connector

[0321] 65 Minimum area RF connector with pin connections 71 Identify chip power management element 71 72 Identify chip modulator / demodulator element 73 Identify chip controller

[0322] 74 Identification chip non-volatile memory 101 Ultrasound system 102 Generator device

Claims

1. An insertion assembly (1) having a radio frequency identifier (3), the assembly (1) being adapted to be inserted into a medical device handpiece (4), the assembly (1) comprising: - an inserter (2) adapted to interact with a part of a patient's body, wherein the inserter (2) comprises an inserter metal tang (5); - a ferromagnetic layer (6) arranged in contact with the insert metal tang (5) of the insert (2), wherein the ferromagnetic layer comprises a ferromagnetic material; - a dielectric layer (7) arranged in contact with the ferromagnetic layer (6); - an insert antenna (8) arranged in contact with the dielectric layer (7) and comprising an insert antenna metal element (9) extending along a predefined substantially planar profile (P) which as a whole at least partially wraps around the metal tang (5), the insert antenna (8) being configured to receive and transmit modulated or unmodulated electromagnetic fields within a given frequency range; - an identification chip (10) operatively connected to the insert antenna (8) and configured to transmit information about the insert component (1) when activated; wherein the ferromagnetic layer (6) is adapted to reduce or eliminate the phenomenon of attenuation and / or distortion of the electromagnetic field caused by field parasitic effects in the vicinity of the insert antenna (8), the field parasitic effects being caused by the interaction of the transmitted / received electromagnetic field with the metal part of the insert metal tang (5), and / or with the liquid present in the insert, and / or with the insert antenna metal element (9); and wherein the ferromagnetic layer (6), the dielectric layer (7) and the insert antenna (8) form a transceiver device (11) adapted to enable wireless communication between the identification chip (10) and a handpiece antenna (12) of the handpiece (4), The dielectric layer (7) is different from the ferromagnetic layer (6), and the dielectric layer (7) is inserted between the ferromagnetic layer (6) and the insert antenna (8) so as to electrically isolate the insert antenna metal element (9) of the insert antenna (8) relative to the ferromagnetic material of the ferromagnetic layer (6).

2. Insertion assembly (1) according to claim 1, wherein: The frequency range includes one or more radio frequency ranges, and wherein the interposer antenna (8) is an RF antenna adapted to operate at radio frequencies, and wherein the identification chip (10) is a radio frequency identification chip.

3. Insertion assembly (1) according to claim 1, wherein: The transceiver device (11) formed by the ferromagnetic layer (6), the dielectric layer (7) and the interposer antenna (8) can be modeled as an electrical circuit, the electrical parameters of which depend on the dimensions and material of the ferromagnetic layer (6).

4. Insertion assembly (1) according to claim 3, wherein: The transceiver device (11) formed by the ferromagnetic layer (6), the dielectric layer (7) and the insert antenna (8) and the identification chip (10) can be modeled as a circuit LC, wherein the inductance parameter La depends on the size and material of the ferromagnetic layer, the dielectric layer and the insert antenna (8), and the capacitance Cc depends on the identification chip (10), and wherein the frequency range in which the transceiver device is suitable for operation depends on the inductance parameter La and the capacitance Cc parameters.

5. Insertion assembly (1) according to claim 2, wherein: The operating frequency range of the transceiver device includes a frequency range in the UHF RFID band between 860 MHz and 960 MHz.

6. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The ferromagnetic layer (6), the dielectric layer (7) and the interposer antenna (8) form a stack having a thickness comprised in the range between 50 and 800 microns, the stack being adapted to be inserted into an interposer having a diameter not exceeding 6400 microns.

7. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The thickness of the ferromagnetic layer (6), ie relative to the radial dimension of the insert, is comprised within the range between 20 and 400 microns.

8. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The ferromagnetic layer (6) is made of a thin high permeability sintered ferrite or a polymer matrix mixed with micron-sized magnetic powder dispersed throughout the material.

9. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The ferromagnetic layer (6), the dielectric layer (7) and the interposer antenna (8) enclose a central metallic element, forming a generally concentric structure.

10. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The insert antenna (8) is made of aluminum.

11. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The interposer antenna (8) has a flat rectangular shape, the short side of the rectangle has a dimension between 1 mm and 6 mm, the long side of the rectangle has a dimension between 10 mm and 30 mm, and the thickness of the interposer antenna (8) is less than 50 microns.

12. The insertion component (1) according to any one of claims 1-5 further comprises a biocompatible protective layer (19), which resists vibration and temperature, and is arranged externally relative to the ferromagnetic layer, the dielectric layer, the insert antenna and the identification chip.

13. Insert assembly (1) according to claim 12, wherein: The biocompatible protective layer (19) is a single-component or multi-component epoxy compound.

14. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The ferromagnetic layer (6) is arranged in contact with the insert metal tang (5) by means of a double-sided adhesive layer (17).

15. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The identification chip (10) is an RFID chip.

16. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The identification chip (10) has a parallelepiped shape, the size of its base is between 50 micrometers and 1200 micrometers and the thickness is less than 300 micrometers.

17. Insertion assembly (1) according to any one of claims 1 to 5, wherein: The identification chip (10) is configured to store and transmit, when activated, through the transceiver device, one or more information belonging to the following set: - a unique and unchangeable identification of said insert component; - information related to the traceability of said inserted component; - information about compatibility with connected medical devices; - Information about suitability for use and clinical interventions relevant to the selected device type; - information about the operating frequency range in which said transceiver device of said plug-in component can operate; - information about the integrity of the insert assembly; - information about whether the insertion component is correctly inserted if it is inserted into the corresponding handpiece; - Information about the operating parameters and operating times of the inserted components; - Error or warning messages in the event of abnormal operating conditions; - Information used to predict and / or plan maintenance.

18. The insertion assembly according to any one of claims 1 to 5, wherein: in, The insertion assembly (1) is configured to operate in connection with medical devices for dentistry and medical applications in the field of orthopedics or other anatomical areas.

19. Insert assembly (1) according to claim 6, wherein: The ferromagnetic layer (6), the dielectric layer (7) and the interposer antenna (8) form a stack having a thickness comprised in the range between 100 micrometers and 600 micrometers.

20. Insert assembly (1) according to claim 7, wherein: The thickness of the ferromagnetic layer (6) is in the range of 50 micrometers to 300 micrometers.

21. Insert assembly (1) according to claim 11, wherein The size of the long side of the rectangle is between 12 mm and 25 mm.

22. Insert assembly (1) according to claim 11, wherein The short side of the rectangle has a dimension between 2 mm and 4 mm.

23. Insert assembly (1) according to claim 11, wherein: The size of the short side of the rectangle is between 2 mm and 4 mm, and the size of the long side of the rectangle is between 12 mm and 25 mm.

24. Insert assembly (1) according to claim 16, wherein The size of the bottom edge of the identification chip (10) is between 100 micrometers and 1000 micrometers.

25. A medical device (20) comprising a control unit (21), a handpiece (4) provided with a handpiece antenna (12), and an insertion assembly (1) according to any of the above claims, the insertion assembly (1) being operatively and mechanically connected to the handpiece (4) of the medical device, and wherein, The inserter antenna (8) is configured to wirelessly communicate with the handpiece antenna (12).

26. The medical device (20) according to claim 25 is configured to manage and control two-way communication with the insertion component (1), and to store the information stored in the insertion component (1) according to claim 17 in the memory of the medical device through IoT technology, and if any, on an external server of the medical device.

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