ITBO20130694A1 - Dispositivo di comando sterilizzabile per il controllo di dispositivi medici - Google Patents

Description

D E S C R I P T I O N

of an industrial invention having the title:

STERILIZABLE DEVICE FOR CONTROLLING MEDICAL DEVICES

The present invention relates to the field of dentistry. More particularly, the invention relates to a system for controlling medical devices wherein there is contact between operator’s hands and a control device which can be sterilized.

Dental practice is a peculiar environment: on one hand it can be likened to a surgical environment, in that some of the operations performed by dentists interrupt mucosal continuity, and therefore can introduce pathogens (bacteria, virus, fungi) into the tissues of the body under treatment. On the other hand, dental environment is on average much dirtier than most surgical environments. This is due to the particular instrumentation normally used by dentists, comprising rotary and non rotary instruments (e.g. turbine, micromotor, ultrasound calculus scaler, etc.), which generate an aerosol cloud containing the microorganisms present in the oral cavity. Indicatively, in a millilitre of saliva there are 5 billions of microorganism, some of which can be pathogenic or opportunistic.

Details on aerosol generation during dental operation can be found in the chapter “Sterilization, Disinfection and Asepsis in Dentistry” in “Disinfection, Sterilization and Preservation”, Ed. Seymour Block, Fifth Edition, Lippincott, Williams & Wilkins 2001, and also in the Guidelines for Infection Control in Dental Health-Care Settings — 2003 Centers for Disease Control Morbidity and Mortality Weekly Report, 2003;52.

This peculiarity of the dental environment, known since the ‘70s, induced manufacturers to find ways to control dental units without using dentist’s hands. A very widespread way is controlling the dental unit (e.g. patient’s chair adjustment; turbine/micromotor increase/decrease of the number of rounds-per-minute, and direction of rotation) through a foot control connected to the dental unit; foot controls are known since the ‘60s. Nonetheless, using feet to control dental units has some limitations, linked both to the lesser precision of foot controls with respect to hand controls, and to the way of controlling through a foot control, which obliges the dentist to memorize complex sequences of actions (typically a foot control only has a couple of buttons and a lever or joy-stick).

Moreover, since the ‘90s, intra-oral cameras have known a wide diffusion as instruments both improving dentist-patient communication, and documenting the different therapeutic phases for medico-legal reasons, too. Given the small dimensions of camera handpieces, often having one button only, navigating among acquired images or video sequences is problematic. Often even the foot control is difficult to use.

Finally, in dentistry digital imaging has become more and more widespread since the ’90s: initially with intra-oral X-ray sensors, then with bigger sensors which are mounted in panoramic and CT apparatuses for the acquisition of patient skull. The consultation of a radiography during a dental operation can be fundamental, like, for instance, in endodontics, or when metal implants have to be placed into maxillary or mandibular bones.

During dental therapies, dentist’s hands are contaminated, in the best cases with patient’s saliva, and in the worst cases with patient’s blood.

In the contact necessary to control a dental device, and particularly a dental unit, two undesired consequences occur:

- Dentist’s hands become contaminated through the contact with the keys and surfaces of the dental device;

- The dental device itself is contaminated with saliva and/or blood present on dentist’s hands through contact.

Nowadays, the most used methods to overcome the two above problems are disinfecting dental unit keyboard and surfaces with suitable disinfectants between patients, and in some cases protecting with a barrier (usually clear plastic wrap) the surfaces. The barriers should be removed and replaced with new ones during re-setting operation between patients. This generates a huge amount of work for dental assistants, and also an important share of operating costs for the dental practice, including mandatory downtime between patients.

Nowadays, when contaminated objects have to be sterilized, the gold standard is the use of a water vapour autoclave, in terms both of repeatability and efficacy. For the skilled person it is apparent that other techniques are available for sterilizing objects, e.g. the use of a chemical vapour autoclave, immersing the object to be sterilized for a sufficient time in a cold sterilizing liquid, the use of different kind of radiations (gamma, UV, cathode, X).

All the above makes very interesting the possibility of removing the control device used to control the dental units, but also dental imaging devices, and to sterilize it.

One has to take into account that in a space as small as a typical dental practice, generally at least a dentist, at least a dental assistant (optional) and at least a nonsedated patient are present at the same time. The removable control device must find a position which is comfortable for professional operators, and not accessible to patient due to safety reasons.

Aim of the present inventions is the use of a removable, sterilizable device to control dental units or imaging devices (intra-oral X-ray sensors and radiographic apparatuses, panoramic apparatuses, Cone-Beam CT apparatuses) in the dental practice.

This object is achieved by a method and an apparatus having the features of the independent claims. Advantageous embodiments and refinements are specified in claims dependent thereon.

The advantages of the present invention are the possibility of controlling medical devices entering into contact only with sterilizable devices, allowing to control medical devices in a simpler, more effective and intuitive way than with a foot control.

For all said above, it is apparent that dental units are the preferred embodiment of the present invention. Nonetheless, the skilled person can apply the same concepts to different kinds of medical devices present in a dental practice, or, more generally, in a medical practice.

The present invention will now be described by way of non-limiting example with reference to the accompanying drawing:

Figure 1 Dental unit.

Figure 1 shows a dental unit, indicated with 1 on the whole, comprising its typical different parts. In Figure 1 there are shown a chair 2, a hydrogroup 3, a dentist’s instrument board 4, an assistant’s instrument board 5, a monitor 6, which can be connected, or not, to a (not shown) external personal computer (PC); an intra-oral X-ray unit 7 supported by an arm linked to hydrogroup 3. Moreover, a dental unit 1 typically comprises a scialytic lamp 10 and a foot control 9.

On the dentist’s instrument board 4 the typical instruments used during dental therapies can be recognized: an air/water dental syringe, a curing lamp, an ultrasound scaler for removing calculus, a micromotor with a contrangle, a turbine. On the assistant’s instrument board 5 a camera is present, whose images can be visualized in real time on the monitor 6. If the dental unit 1 is connected to an external PC (not shown), digital patient records can be consulted, comprising all patient’s information like personal data, therapy plan, already performed therapies, already acquired visible or X-ray images. Moreover, on dentist’s instrument board 4 a dentist’s control console 8 is typically present, which allows to modify the operating parameters of dental unit 1. The console 8 is typically provided with a small display for visualizing information. On the most advanced versions of the control console 8, different kind of information can be visualized, among which information on the patient, on the already performed therapy or patient’s radiographic images.

It is apparent that all the instruments need controls in order to be used, starting from patient’s chair 2 adjustment. Nowadays, most instruments are controlled through foot control 9, with more or less complex combinations of sequential actions. Often, to make controlling more user-friendly, the removal of an instrument from instrument board 4 leads to showing a menu relative to the adjustment of the removed instrument on control console 8.

The use of sterilizable control device allows to control each instrument present on dental unit 1 (exemplary but non-limiting list):

a) patient’s chair adjustment (chair seat height and backrest tilting);

b) adjustment of rotary and non rotary instruments present on dentist’s instrument board 4 (e.g. number of rounds per minute and selection of direction of rotation for rotary instruments);

c) control of dental radiographic devices/apparatuses;

d) acquisition of images from camera;

e) visualization of multimedia contents by the dentist, among which navigation in the already acquired camera or radiographic image archive and information positioned in electronic patient’s record shown on monitor 6;

f) visualization of multimedia contents on monitor 6 by patient;

g) power up and down and adjustment of emission parameters of the light emitted by a scialytic lamp;

h) repetition of keyboard/console commands;

i) dental unit maintenance;

j) control of dental unit accessories: dental cup, dental suction;

k) control of apparatuses external to dental unit, but linked to it (e.g. intercom/door phone);

l) recognition/authentication of operator.

The invention consists in providing a support working as contact surface with operator’s hand to control the medical device. The support, if chosen of a suitable material, can withstand the sterilizing process (sterilization in autoclave, by immersion in a cold sterilizing solution, etc.).

The support can be used in two distinct modalities, which can be combined:

i) The support can be used as a touchpad, allowing to control a pointer moving on a monitor/screen on which a menu or a graphic interface is present.

ii) The support can be used as a keyboard, subdividing its surface into different areas in a permanent or variable way, depending on the context; each area is connected with different commands. In this case, printed or projected icons must be visualized on the support, in order to allow the user to know which command he/she is using.

Different technologies are available, allowing to detect the position and the contact of fingers with respect to support surface. For instance (exemplary non-limiting list): a) Image detection and process

The support (for instance a simple plastic tablet) is framed by a device for gesture recognition detecting the contact with the support surface detecting both the position and the contact of fingers with support surface. The support can be used in the two above described i) and ii) modalities. If the support is used as a keyboard, icons may be present so that the operator knows which command he/she is using. Typically this technology makes use of at least an image sensor and a specific software. In this group both image sensors working in the visible range, and devices like LeapMotion and Kinect, making use of infrared rays, are included.

b) Surface acoustic wave (SAW) technology

The support is in contact with at least two transducers which, detecting the pressure, can detect the position and the touch of fingers with respect to support surface. In this way the position of the fingers can be detected and communicated to the system. The support can be used in the two abovedescribed i) and ii) modalities.

c) Virtual keyboard (laser keyboard)

A bundle of infrared light is projected immediately above the support, generating a plane sensitive to touch. Touch is detected by intercepting the reflection of the light bundle caused by fingers, (even a plurality of fingers, multitouch) determining the position of one or more fingers on the support. At the same time on the support an image can be projected, generally through red light laser, subdividing the support into sensitive areas, each of which is associated with a different command; possibly the projected image can vary according to the context. E.g. there can be a series of specific commands for controlling a turbine and a series of specific commands for adjusting patient’s chair.

d) Support with touch technology

The sterilizable support contains electronic components detecting touch and position. E.g. a capacitive touch screen panel comprising a printed circuit board inserted in two plastic housings so as to be air- and watertight thanks to ultrasound welding.

In points a), b), c), the support can be free of any electronic component.

As a plurality of actors are present around the dental unit (typically a dentist, an assistant, and a patient), it is possible that each of them has his/her own device for controlling the dental unit. Obviously, for safety reasons, patient’s control device shall have a control menu much more limited with respect to professional operators’ menu; the patient’s menu probably should only be able to interact with multimedia contents present on monitor 6.

Alternatively, the sterilizable control device could be only one, and could be configurable or fixable in different positions of the dental unit, and performing different operations according to the position of the dental unit to which it is fixed.. The fixing position of the support must limit the access to non-professional actors, so as to preserve system safety and prevent undesired interactions with the dental unit.

If multiple positions for fixing the support are present, each identifying the use by different actors (dentist, assistant, patient), the position of the support determines both the actor using the support and the set of commands which can be used. The system is set so as to detect the fixing of the support in the possible different positions. For instance, in an embodiment, the support for the dentist is fixed to dentist’s instrument board 4, the support for the assistant is fixed to the assistant’s instrument board 5, while the support for the patient is fixed to the screen 6 or to patient’s chair 2.

The embodiments can vary.

A non-limiting embodiment has a continuous, closed structure or frame, or alternatively an open one, wherein a substantially planar contact element is fixed; the planar element forms the contact surface on which the operator’s hand works; the fixing occurs through snap-fit or magnetic coupling, or alternatively or in combination with tightening means. Means for detecting contact area or areas of one or more fingers of operator’s hand with the contact surface are fixed to the structure or frame in a permanently integrated or removable way.

In this way, the contact element can be assembled and disassembled from the structure or frame, and sterilized. Moreover, as in the inactive version (free of electronic components, see above) the contact element is only a piece of material, the apparatus can be provided with at least two contact elements to be used alternatively. This allows to sterilize one contact element while the other is in use. Given the low cost of the contact element, this embodiment does not generate a substantial cost increase.

With a passive contact element, it is also possible to have an image projector permanently or removably integrated in the structure or frame, projecting the image of the graphic interface on the contact surface of the contact element.

Having a passive and removable contact element, and the part of position sensor associated to the fixing means of the contact element, allows to move the contact element in any apparatus and in any position.

According to an advantageous embodiment, when the graphic interface is permanently printed on the contact surface, a stable memory support for a configuration file of the graphic interface, which is uploaded in the control logic system of the apparatus and/or in the detecting system of contact area(s), so that the apparatus is automatically set to recognize the commands and the adjustments performed with the specific graphic interface.

Alternatively, e.g. these information may be stored in a RFID tag or in an other transponder circuit, permanently buried or incorporated in the material of the contact element, or housed so as to be hermetically sealed in a cavity of the thickness of the contact element.

In this case, if the apparatus, e.g. the dental unit, is provided with a RFID reading and writing system, or compatible with the transponder, the interface itself and the sensors of the contact areas can configure automatically in a way suitable for the graphic interface on the contact surface of the contact element. The use of technologies like RFID tags allows the univocal identification of the contact element. This allows to store an event log on the apparatus memory. Such data, if the transponder allows writing in an internal memory (e.g. NFC), can be stored also inside the contact element itself. The embodiment projecting the graphical interface on the surface of the contact element has also the possibility of a semi-automatic configuration, through upload of configuration files stored on a memory support, like e.g. a CD-ROM, a memory stick or other and also of an automatic configuration through use of RFID or other kinds of transponder.

Similar features and similar means can be present also with an active contact element with a contact surface of touchscreen type as described above.

In this case the contact element of touchscreen type can communicate through Wi-Fi protocols, allowing also to automatically modify the interface when the same contact element is moved from a workspace to another, or from an area specific for the dentist to an area specific for the assistant or the patient on the same dental unit. In this case the apparatus sends the information, or only the activation command of the different interfaces. This operation can be started thanks to an initializing command which is given through suitable means by the user him/herself when mounting the contact element of the touchscreen type on a given structure or frame, so that interrogation and configuration procedures start which lead to uploading the correct or desired interfaces.

In an alternative embodiment, the contact surface is not fixed to the dental unit, but is held by the operator. The necessary sensors are integrated in the dental unit, e.g. fixed to the lamp post, or the scialytic lamp, or the monitor, or possibly fixed to the ceiling. In this case, too, the contact surface can be totally free of electronic components, or comprise electronic components detecting touch and position, e.g. a capacitive sensor, or electronic components exchanging with the dental unit, mono- and bi-directional information, like a RFID or NFC tag.

Claims (10)

1. R I V E N D I C A Z I O N I 1) Metodo per impartire comandi a dispositivi medici facente uso di un supporto che funge da superficie di contatto con le mani dell’operatore sanitario e/o del paziente caratterizzato dal fatto che il supporto è rimovibile e può essere sottoposto ad operazioni di sterilizzazione.
2. 2) Metodo per impartire comandi a dispositivi medici secondo la rivendicazione 1, in cui le operazioni di sterilizzazione sono tratte dal gruppo consistente in: sterilizzazione in autoclave a vapore d’acqua, autoclave a vapori chimici, immersione per un tempo adatto in una soluzione sterilizzante a freddo, oppure uso di radiazioni di diverso tipo.
3. 3) Metodo per impartire comandi a dispositivi medici secondo la rivendicazione 1, in cui la tecnologia che permette di impartire i comandi al dispositivo è tratta dal gruppo consistente in: a) uso di un dispositivo per la rilevazione e l’elaborazione delle immagini dotato di almeno un sensore di immagini nello spettro del visibile e/o dell’infrarosso ed uno specifico software; b) tecnologia ad onde acustiche di superficie con uso di almeno due trasduttori; c) tastiere virtuali ottenute proiettando una immagine sul supporto dotate di tecnologia atta a rilevare la posizione delle dita sul supporto; d) un supporto sterilizzabile contenente al suo interno componenti elettronici atti al rilevamento del tocco e della posizione.
4. 4) Metodo per impartire comandi a dispositivi medici secondo la rivendicazione 3, in cui il supporto può essere utilizzato in due modi distinti, combinabili fra loro: - il supporto può essere utilizzato come un touchpad che permette di controllare un puntatore che si muove su uno schermo su cui è presente un menu o una interfaccia grafica; - il supporto può essere utilizzato come tastiera suddividendo in maniera fissa o variabile e dipendente dal contesto la sua superficie in aree, ciascuna delle quali associata a comandi differenti; sul supporto possono essere visualizzate delle icone stampate o proiettate per permettere all’utente di distinguere quale comando sta impartendo.
5. 5) Metodo per impartire comandi a dispositivi medici secondo la rivendicazione 1, in cui è presente un solo supporto, e detto supporto può essere posizionato in zone diverse del dispositivo medico.
6. 6) Metodo per impartire comandi a dispositivi medici secondo la rivendicazione 5, in cui l’aggancio del supporto nelle diverse collocazioni del dispositivo medico abilita menu differenti a seconda dell’operatore (medico, assistente, paziente).
7. 7) Metodo per impartire comandi a dispositivi medici secondo la rivendicazione 1, in cui sono presenti più supporti, uno per ciascuno degli attori che girano intorno al dispositivo medico (medico, assistente, paziente), e ciascuno dei supporti consente di impartire i comandi coerentemente con il proprio utilizzatore.
8. 8) Metodo per impartire comandi a dispositivi medici odontoiatrici secondo una delle rivendicazioni precedenti, in cui i dispositivi da controllare sono scelti nel gruppo consistente in riuniti odontoiatrici, panoramici, apparecchiature per cone-beam CT, apparecchiature radiologiche ibride panoramici/CBCT, sensori e apparecchiature radiografiche intraorali.
9. 9) Supporto in grado di agire come superficie di contatto con le mani dell’operatore per impartire comandi a dispositivi medici secondo le rivendicazioni 1-8, caratterizzato dal fatto di essere rimovibile, essere costruito con un materiale in grado di sopportare la sterilizzazione, e opzionalmente comprendente icone e/o immagini stampate o proiettate sulla propria superficie.
10. 10) Riunito odontoiatrico (1) comprendente una poltrona (2) per il paziente, un gruppo idrico (3), una tavoletta strumenti (4) dell’odontoiatra completa di consolle (8), opzionalmente una tavoletta strumenti (5) dell’assistente, uno schermo (6), opzionalmente una lampada scialitica (10), opzionalmente un radiografico endorale (7), un comando a piede (9) caratterizzato dal fatto di comprendere un supporto in grado di eseguire il metodo delle rivendicazioni 1-8.