ITFI20080131A1 - "PROGRAMMABLE ELECTROMEDICAL SYSTEM" - Google Patents

Description

"Programmable electro-medical system"

Technical field

The present invention relates to the sector of electromedical equipment. More particularly, the present invention relates to improvements in electro-medical equipment for diagnosis and therapy, in particular using laser sources for treatment.

More particularly, the present invention relates to a complex of interfaced and integrated devices for the diagnosis and therapy, for example but not exclusively of skin ulcers.

State of the art

Skin ulcers belong to the family of chronic-disabling diseases with a high tendency to relapse and which mainly involve elderly subjects. In these cases the social costs, both direct and indirect, deriving from the treatment of this pathology are enormous and difficult to control. For example, in Italy there are about 2,000,000 patients suffering from chronic skin ulcers. Furthermore, these chronic-disabling diseases are characterized by a high socio-economic impact, a high tendency to recidivism and have an extremely low clinical efficacy / social cost index. In other words, they are burdensome diseases for the National Health System (S.S.N.) and for these it is necessary to identify every possible solution towards an effective therapeutic path.

Currently, the diagnosis and therapy of this and other types of chronic invalidating diseases require a long time and the use of different equipment and equipment for diagnosis, treatment and verification of the outcome of the treatment.

Summary of the invention

According to one aspect, the object of the invention is to provide an electromedical system or apparatus which overcomes in whole or in part one or more of the drawbacks and limits of traditional apparatus.

The purpose of an embodiment of the invention is to propose an electromedical equipment or an electromedical system (which can also be defined as an electromedical "unit", and in the sense of a system that collects and also functionally integrates a plurality of devices and / or equipment) which allows the diagnosis and treatment of chronic skin ulcers (for example due to bedsores, varicose veins and diabetes) through the integration of diagnosis and therapy.

The study of the diagnostic-therapeutic procedure that has been implemented has resulted in the development and fine-tuning of a programmable opto-mechatronic electromedical system. This system integrates multiple diagnosis and treatment systems by introducing minimally invasive multidisciplinary solutions capable of improving the clinical performance of the procedure itself while reducing its socio-economic impact. In summary, the heart of the invention consists in the functional integration of the various diagnostic and therapeutic devices used. Functional integration means a combination of diagnostic and surgical or therapeutic devices, such that the data detected by the diagnostic devices are used directly for the control and management of the therapeutic and / or surgical devices. In some embodiments, the integration takes place through a software and a control system interfaced with diagnostic devices and therapeutic and / or surgical devices.

The functionally integrated system via software could include at least four different configurations of the aforementioned devices, which could be:

1) physically separated and manually moved by the operator;

2) physically separated and handled with a robotic system;

3) physically joined and manually moved by the operator;

4) physically joined and moved with a robotic system.

Basically, in one embodiment, the invention provides a minimally invasive system of diagnosis and treatment, integrated and modular with the use of at least:

- a diagnostic system;

- a surgical system and / or a therapeutic system.

<In particular, the diagnostic system may include:>

• a modeling system, having at least one camera used both to create a 3D model of the lesion and to acquire morphological and structural information (texture analysis - edge detection) as well as colorimetric; • a surgical and therapeutic treatment system, including at least <one source of electromagnetic radiation;>

• a manual or robotic handling system for the devices provided <by the modular system;>

• an electronic processor control unit;

• an archiving database.

In particular, the diagnostic system can include one or more of the following devices: oximeter, laser doppler, ecodoppler, 3D scanner for volumetric analysis, colorimeter, thermal imaging camera, pyrometer, and other generic diagnostic devices. Furthermore, for diagnostic purposes, the devices can be integrated with diagnostic procedures external to the unit, for example the functional evaluation of the perfusion capacity of the tissues by means of oxygen insufflation and monitoring of its peripheral partial pressure.

The surgical system used in the preparation of the skin ulcer bed can include at least one of the following devices: CO2 laser for vaporization (debridment), equipped or not with electronic beam scanning and a fume extraction system, CO2 laser for cutting, Nd laser : YAG for the sterilization of any fistulous tracts using optical fibers, electrosurgical units, thermo-cautery, Vacuum, refrigeration system for the tissues to be treated with laser, device for washing the wound with sterile water, water-based tissue dissector, as well as other generic treatment devices. Even in the surgical field, the integrated system can make use of external devices such as traditional scalpels and other similar devices.

The therapeutic system can include one or more of the following devices: laser sources at various wavelengths (λ: 632 nm - 10,600 nm) with different possibilities of impulse emission (CW - PW), sources with non-coherent electromagnetic radiation ( IPL, LEDs etc ...), ultrasounds, iontophoresis, electroporation, vibrational systems, Vacuum, TECAR (Capacitive and Resistive Energy Transfer), magneto-therapy, CEMP (pulsed electromagnetic fields), focused shock waves, electrotherapy, RF (radio frequency ), as well as other generic devices for therapeutic use.

Brief description of the drawings

The invention will be better understood by following the description and the attached drawing, which shows a practical non-limiting embodiment of the invention. More specifically, in the drawing they show: the

Fig.1 a functional diagram of an integrated system according to the invention; Fig.2 a block diagram of a system according to the invention; there

Fig.2A a diagram of possible connections of some functional blocks of the system of Fig.2; the

Figs. 3 to 7 functional diagrams and diagrams of the system according to the invention and the respective operating modes; and the

Fig.8 is a map of the advantages achievable with the system of the present invention.

Detailed description of embodiments of the invention

Fig. 1 shows the basic functional blocks making up the proposed opto-mechatronic programmable electro-medical system. Basically, in the illustrated embodiment the integrated opto-electronic programmable electro-medical system comprises in combination the following basic functional blocks: a protection system 1, a diagnosis system 2, a control system 3, a three-dimensional vision system 4, a system 5 for aspirating the fumes produced by the laser treatment of fabrics, a man-machine interface 6, a handling system 7, an integrated treatment / therapy bed 8, a database 9, a treatment system.

Fig. 2 shows a more detailed block diagram of an integrated system according to the invention. In this embodiment, the system comprises a plurality of diagnostic devices or systems and in particular: a thermal imaging camera 21, an oximeter 22 and the three-dimensional vision system, represented here by block 23. The three-dimensional vision system can comprise one or more cameras and allows the detection of both diagnostic and morphological information of the treatment area and the creation of a 3D model of the treatment area. The 3D vision system can be housed both on a robotic arm and on a stationary support system;

The diagnostic systems can be moved by the robotic arm or by the operator himself. The block diagram of Fig. 2 also shows other devices for the collection of physical and / or physiological quantities useful for the diagnosis and / or control of the treatment, qal in particular: a Doppler laser 24, a system for measuring the volume 25, a colorimetric measurement system 26 and a generic diagnostic device 27. Reference 28 indicates generic sensors which can be used to detect further quantities.

Still in the functional diagram of Fig. 2 treatment systems or devices are indicated, and in particular: a therapeutic CO2 laser 31, a surgical CO2 laser 32, a Nd: YAG laser 33, a source of non-coherent electromagnetic radiation 34, a generic system treatment 35. These systems can also integrate a laser scanning device.

In addition to the vision and treatment devices listed above, the programmable electro-medical system represented in the block diagram of Fig. 2 includes one or more handling systems, generally indicated with 41, such as for example one or more robotic arms, capable of handling the beam lasers and other functional blocks in the space around the patient and especially on the treatment area. In addition to the movement systems, one or more stationary supports can be provided, suitable for accommodating and supporting one or more functional blocks with particular reference to the 3D vision system.

The various devices and functional blocks are interfaced to a control unit or system 43, for example a personal computer or a server, which manages and controls, by means of software, the various functional blocks. A database 45 is integrated with this control unit, containing data of diagnostic interest, used for example to provide information of a council nature and not restrictive to the operator. The control unit 43 can also be interfaced with a hospital information system 47.

The diagram in Fig.2 also shows: a machine-man interface, for example an LCD monitor 49 with touch-screen technology, through which the operator enters operational data, receives diagnostic and therapeutic information and alarm messages; a printer 50, used for example for printing diagnosis and / or treatment reports; a system 52 for the aspiration of the fumes generated by the laser-assisted debridement of the fabric; one or more protection systems 51 against electrical, electromagnetic, mechanical and functional risks. By way of example, the following are potential types of protection <against some of the risks listed above:>

3⁄4 against mechanical risks, for example, the use of an accelerometer system or any other device could be envisaged, which through the mediation of the control system, interrupts the power supply of the <laser source;>

3⁄4 against electromagnetic risks, for example protection from multiple reflections and unwanted trajectories of the laser beam.

The equipment can be equipped with a system integrated with it and designed to accommodate and move the patient (for example a chair similar to that of dental units) and to contain some bulky parts of the equipment.

Fig.2A shows a block diagram which schematically shows the connections between a Personal Computer or control server of the entire complex of integrated equipment, interfaced with a scanning system, an oximeter, two therapeutic lasers and / or surgical, to a monitor on which the doctor can observe the patient and / or a portion, for example, of the skin of the patient being treated, and a touch-screen display. Fig. 2A shows in particular the USB, serial, firewire, VGA ports or interfaces that can be used for connections.

Fig.3 shows the main features of the invention. These characteristics must also be considered as key terms characterizing the system in question.

The system of the present invention is modular in that it offers the possibility of adding one or more diagnostic and therapy blocks to the system according to the characteristics of the pathology and of the tissue to be treated. This system is also integrated in that it provides at least one diagnosis system and at least one therapy system. The integration is not limited to the physical space-time condensation of the systems involved, but adds the functional aspect, as schematically represented in Fig.4.

For example, the device provides the operator with useful elements for defining therapeutic procedures having, in the diagnostic phase, previously acquired data relating to the characteristics of the lesion to be treated. Furthermore, the device, through the diagnostic systems, offers the possibility of controlling the therapeutic procedure in progress through retroactive information, as shown in Fig. 5

The system extends the classic concept of minimally invasive which is aimed exclusively at the surgical act. In fact, a surgical procedure is defined as minimally invasive when it is capable of minimizing the histo-damaging impact on healthy tissues (for example, all interventions performed endoscopically). The basis of the invention is the principle according to which the concept of minimally invasive must be extended to every aspect of the medical act, which includes: diagnosis, therapy and surgery. In other words, the classic concept of minimally invasive tends to preserve the healthy tissues adjacent to the lesion area; while the concept of mini-invasiveness underlying the present invention aims to preserve the patient's quality of life, as schematically reported in Fig. 6. The system of the present invention allows to make a medical procedure minimally invasive as it allows to:>

<• reduce the time required for individual medical procedures;>

• spatially condense multi-specialist and / or multidisciplinary procedures; • temporally condense multi-specialist and / or multidisciplinary procedures. The extension of the concept of minimally invasive space and time represents a new element compared to the state of the art. It is important to emphasize that the elements mentioned above can be both present and separated from each other without the system losing its minimally invasive feature. Consequently, the minimally invasive integrated system offers advantages for the patient, for the operator as well as for the national health system. In particular, for the patient, two spheres of analysis can be identified: one of a biological nature and the other emotional; as shown in Fig. 7.

The biological advantages concern the effectiveness of the medical act (for example, rapid, less painful intervention, less post-operative edema and less bleeding) with beneficial effects for the patient mainly in the medium and short term. All this indirectly entails benefits for both the operator and the S.S.N., mainly as regards the reduction of direct costs.

The medical evaluation of the evolution of the lesion, which arises from the comparison of the acquired data (for example photographic images, quantitative indices of volume, oximetry, colorimetry, etc.), significantly influences the emotional sphere of patients and their loved ones by providing them new vital stimuli that are fundamental in medium and long-term healing. Furthermore, this determines benefits of a socio-health nature mainly inherent in indirect costs. Fig.8 shows a map of the advantages produced by the use of the proposed minimally invasive integrated system.

Claims (5)

"Programmable electro-medical system" Claims 1. A medical system aimed at the functional integration of at least one diagnostic device and at least one surgical or therapeutic device. 2. System according to claim 1, in which said at least one diagnosis device and said at least one surgical or therapeutic device are interfaced with an electronic control unit, programmed to receive data from said diagnosis device and use them for the management of said surgical or therapeutic device. 3. System according to claim 1 or 2, wherein said system comprises in combination: - a diagnostic system; - a surgical system; - a therapeutic system. < 4. System as per claim 1, 2 or 3, comprising in combination:> • a modeling system, having at least one camera used both to create a three-dimensional model of a tissue lesion to be treated, and to acquire morphological-structural information (analysis texture - edge detection) <as well as colorimetric;> • a system of both surgical and therapeutic treatment, comprising at least <one source of electromagnetic radiation;> • a manual or robotic handling system for the devices provided <by the modular system;> • an electronic processor control unit; • an archiving database. 5. A system as per one or more of the preceding claims, in which said <devices are physically integrated according to one or more of the following configurations:> <• separated and moved manually by the operator;> • separated and handled with a robotic system; • joined and handled manually by the operator; • joined and handled with a robotic system.