★ * * *

Field of the invention

The present invention relates in general to managing health information by means of storing personal identification data and the relative individual clinical data, and a telecommunications network through which such data can be made available for any need.

State of the prior art

Systems of this type are generally known, for example, from documents US-5 899 998, WO-2006/067821, WO-03/073353 and WO-2011/088565. They are based on the use of electronic devices of the smart card type, for storing individual clinical data and reading such data so as to configure a kind of electronic health file that is immediately consultable and easily upgradeable.

Summary of the invention

The invention proposes to make a system and a method available for managing health information, with particular and specific reference to individuals who are bearers of implanted medical devices.

Today, the area of such devices is constantly evolving and includes a wide range of medical products (for example, heart valves, pacemakers, vascular grafts, stents, breast implants, orthopedic prostheses, osteosynthesis plates and screws etc.) usually intended to be fully or partially implanted into the human body through surgical intervention, and intended to remain there after the intervention. This variety of medical products requires the knowledge, in time, of the type and characteristics of the device of which the patient is a bearer, for example to evaluate the opportunity of being able to be subjected to specific exams such as magnetic resonance imaging, or for the necessary verifications in case of malfunctions or even the need for replacing defective devices, and also in emergency situations where the possibly unconscious patient must be subjected to particular treatments or surgical interventions.

The object of the invention is therefore to make a solution available that meets the aforesaid requirements in a practical, safe and functional manner.

According to a first aspect of the invention, this object is achieved by a system for managing health information of individuals bearing implanted medical devices, characterized in that it comprises:

- a card provided to the individual intended to be subjected to implantation of the medical device, said card bearing an identification access code, which is electronically readable,

an RFID tag applied to the package of the medical device to be implanted into the individual provided with said card, and arranged to be activated upon opening of the package to transmit identification data of the medical device to a receiver, immediately before implantation thereof,

- a centralized database in which identification data and clinical data of the individual are stored, which are accessible through said identification code, said database being connectable to said receiver so as to univocally associate said identification data of the medical device with said individual. Thanks to this solution idea, patients who intend to use the system according to the invention and who are therefore equipped with the relative card, for example in credit card-form, can access the centralized database via the Internet, where the information that forms his/her health file is stored. The patient will then be able to refer to the medical personnel- from anywhere, at any time and for any need- all the information about him/her, and in particular information relating to the medical device which he/she bears, starting from the diagnostic tests to the implantation interventions and the specific characteristics of the implanted device: in other words, everything that can be useful to the medical-health facilities with which the patient may have to deal with.

The medical personnel will then be able to reconstruct the medical history of the patient bearing the implanted device by providing all the correlated documentation, where necessary, in an almost instantaneous manner.

The code of the card can be, for example, a bar code, and more conveniently of the QR type, readable with the aid of any suitable electronic device, for example by an optical reader connected to an Internet connection terminal, equipped with a display, or a smartphone or a tablet, possibly for successive access levels. In a first screen, the basic data of the patient can be displayed, while for successive levels, authentication could be provided through a personal code (password) of the user or a code provided to health care operators when, under certain conditions, such as in an emergency, they need to consult the patient's clinical data. An additional level of access could also be provided for administrators of the database, or rather the organization that manages the service and that can make changes and updates to the data where necessary. Each consultation and updating operation will obviously be recorded with the reporting of the type of intervention, the date and the author.

The card provided to the patient, instead of only serving as an access key to the data, can also possibly consist of a chip or smart card suitable for digital data storage. The information relative to the patient may also include, in addition to textual data, images, graphics, videos and any type of correlated content.

The system according to the invention has obvious advantages both for the user, thanks to the appreciable improvement in the conditions of access to care and treatment, including the possibility of no longer having heavy loads of paperwork required for each visit or consultation, and for the public health service that can be drastically streamlined and made more efficient from an administrative standpoint, and obviously for the operativity of the health professionals.

According to a unique feature of the system according to the invention, the RFID tag associated with the medical device to be implanted is of the semi- active-type with an electric power source normally isolated by a protection barrier. The RFID tag is applied to the inside of the package of the device and the isolating barrier can be advantageously removable due to the opening of the package.

According to another aspect, the invention also provides a method for managing health information of individuals bearing implanted medical devices, characterized in that it comprises the steps of:

providing a centralized database accessible through authentication,

- storing identification data and clinical data of the individual intended to be subjected to implantation of the medical device in said database,

- providing said individual with a card bearing an electronically readable identification access code,

accessing said database by means of said identification access code,

- equipping the medical device to be implanted into the individual with an RFID tag designed to transmit identification data of the medical device to said database, immediately before implantation,

- connecting said receiver to said database,

- univocally associating, in said database, said identification data of the medical device with said individual .

The step of univocally associating said identification data of the medical device with said individual is firstly conducted in a temporary manner and subsequently in a definitive manner.

Brief description of the drawings

The invention will now be described in detail with reference to the accompanying drawings, in which:

Figure 1 is a flow chart that exemplifies the system and method according to the invention in the form of a block diagram, and

Figure 2 is a schematic perspective view of a package for a medical device to be implanted, provided with a component of the system according to the invention .

Detailed description of the invention

Referring initially to Figure 1, the flow chart illustrated therein exemplifies the invention in relation to the case of a patient, intended to be subjected to implantation of a medical device, who is already equipped with a personal card on which a QR code is printed to which they correspond. In addition to the personal data of the patient, clinical data also correspond to this code, such as medical history, results of exams, ultrasounds, x-rays and everything else needed in preparation for the implantation surgery. These personal and clinical data are stored in a centralized database with a possible "cloud" structure, operated by an organization to which the patient has adhered by registering. The centralized database is normally accessible via the Internet.

For access to the stored data and for possible modification of the data, by means of the QR code printed on the card, authentication by a personal password is obviously required. Analogous authentication will also be provided by authorized medical personnel.

Following programming of the implantation and of the patient access to the health facility (block 1), activation of the procedure is carried out by reading the QR code of the card of the patient and consequent access to the central database (block 2) . The reading can be carried out through any usual electronic system and the central database is conveniently accessed via the Internet. Then, the patient can be transferred to the operating room (block 3) .

The preparation of the medical device to be implanted into the patient then follows, which is typically contained in a package of the type represented, simply by way of example, in Figure 2. In this example, the package consists of a box A with a cover B within which an RFID tag is applied, indicated with T, or rather a device for radio frequency identification, of the known semi-active type, which is connected to an accumulator formed by a micro-battery or by a capacitor C able to conserve energy for the entire validity period of the medical device to be implanted and to issue a single pulse sufficient to supply the electronic circuit of the tag T for one time only. The tag T and the accumulator C are, for example, carried by a label applied to the inner face of the cover B and electrically isolated from each other by a thin barrier of non-conductive material P. The arrangement can conveniently be such so that the opening of the cover B of the box A containing the prosthesis to implant causes the mechanical removal of the isolating barrier P and issue of the pulse of electrical energy of the accumulator C to the tag T in order to supply a transmitting antenna S and the electronic logic circuit containing all identifying information of the prosthesis to be implanted for transmission towards a receiver or reader, which is in turn connected or connectable to the central database.

These steps are represented by blocks 4, 5 and 6: the package A with the prosthesis to be implanted is transferred, for example, to the waiting room of the operating room (block 4), and is then opened (block 5) in such a way as to allow, by means of reading the RFDI tag, association of the prosthesis with the patient. In this step, the prosthesis is also unloaded from the stock of the hospital or clinic.

This association is, however, temporary, as the registration of the data of the prosthesis and its correlation to the patient by the central database will only become definitive after two verifications and the relative confirmations: the ascertainment of the integrity and functionality of the prosthesis (block 7) and then, after its implantation in the patient (block 8), the confirmation that nothing else is necessary from a clinical and surgical point of view (block 9) . Where the first verification gives a negative result, the prosthesis/patient association is canceled (block 10) , as for the case in which the second verification is negative. In such cases, the procedure is repeated with a new device to be implanted (block 4 and successive stages).

When the two verifications are both positive, the implanted device/patient association is consolidated, or rather made definitive (block 11), with its final registration in the central database (block 12) and the conclusion of the procedure (block 13) .

Of course, the details of the system can be widely varied with respect to what is described and illustrated, without thereby departing from the scope of the present invention. Thus, for example, if the patient is lacking the card with the access code to the centralized database (for example, because it is not yet registered) , a further RFID tag may be provided, applied to a bracelet or the like, intended to be worn by the patient and then read with the same system at the time of his/her entry into the operating room, in order to complete the patient-prosthesis association in the same manner described above, which will then be definitively confirmed when the patient then gets his/her personal card.