FR2678825A1 - DEVICE FOR PROMOTING BLOOD CIRCULATION IN THE BODY OF A PATIENT. - Google Patents

Abstract

The device comprises means (4) for the detection of the patient's heart pulsations (10), means (6) for applying pressure impulses at regular intervals on at least one part of the patient's body (10) and control means for adjusting said pressure impulses in keeping with the heart pulsations according to predefined instructions during at least one treatment session. Input means (14) are provided for reading the predefined instructions on a data medium (16) and addressing them to the control means. For use in the treatment of arteriopathies by pressotherapy.

Description

 The present invention relates to a device for promoting blood circulation in the body of a patient. This device is used to apply pressotherapy treatments to the patient.

 The pressotherapy technique was developed by a Swiss doctor, Doctor Fuchs, to treat arterial diseases by pneumatic stimulation of blood pressure, synchronized with the cardiac systole. US-A-2 690 174 illustrates this technique and pressure therapy devices produced according to the teaching of this patent are marketed under the name Syncardon. In these devices, an electrocardiogram and a patient's sphygmogram are recorded. The sphygmogram, which translates the arterial pulsations in the area to be treated of the patient's body, provides information on the blood circulation between the heart and this area and therefore on the quality of blood nutrition in this area. From a visualization of the sphygmogram on an oscilloscope, the doctor can diagnose an arteriopathy, for example when the time taken by the blood to go from the heart to the area to be treated is too long relative to the period of the heartbeat or when the sphygmogram has a profile deviating from an ideal profile corresponding to a healthy individual. For treatment, apply local pressure pulses synchronized with the systolic pulses of the electrocardiogram in a cuff placed on the portion of the limb to be treated (upstream of a possible lesion). The synchronized pneumatic pulses have the physiological effect of increasing the power of the vascular systole, which results in an increase in capillary, venous and lymphatic flow and therefore in an improvement of the blood nutrition in the tissues of the area to be treated. The doctor must adjust according to his diagnosis the parameters determining these synchronized pressure pulses, in particular the delay in synchronization of the pressure pulses relative to the cardiac pulses, as well as the amplitude and the duration of each of the pressure pulses.

 In this treatment phase, the numerous adjustments are decisive for the effectiveness of the device and must therefore be carried out under the responsibility of a doctor. As pressure therapy, which generally involves several treatment sessions per week or even per day, is often intended for bedridden patients, its use remains limited in practice because it requires the patient to be transported to the doctor's office.

 US-A-4,077,402 describes a pressure therapy device in which a number of settings are automated. However, this device always requires the presence of the doctor during the treatment sessions, in particular to define the maximum pressure to be applied, so that the above disadvantage is not eliminated. Furthermore, this device proves to be less effective from a therapeutic point of view than those marketed under the Syncardon brand.

 An object of the present invention is to provide a pressotherapy treatment device for which the presence of the doctor during the treatment sessions is not essential.

 Another object of the invention is that the device is generally dedicated to treatment and not to diagnosis, so that it has a simpler and less costly constitution.

 A further object of the invention is that the treatment device is easily adaptable to the particular case of each patient who is to receive the treatment.

 The invention thus provides a device for promoting blood circulation in the body of a patient, comprising means for detecting the patient's heartbeat, means for applying periodic pressure pulses to at least part of the patient's body and control means for adjusting the pressure pulses in correspondence with the cardiac pulses according to predetermined instructions during at least one treatment session.

 According to the invention, this device is characterized in that it comprises input means for reading the predetermined instructions on an information medium and sending them to the control means.

 The device according to the invention can advantageously be installed in the patient, without the treatment sessions requiring the presence of the attending physician. The predetermined instructions, comprising the parameters for adjusting the applied pressure pulses, are defined beforehand by the attending physician during a diagnostic session, and transmitted to the control means of the device during the treatment session via the support. of information. The patient cannot therefore prescribe a treatment session himself by defining in particular the adjustment parameters, this imperative generally having to be respected when home care is practiced.

 In a particular embodiment of the invention, the input means comprise a reader receiving in service a removable information medium, such as a card, a disc or a magnetic tape, on which the predetermined instructions are written.

Other features and advantages of the present invention will appear in the description below of an exemplary embodiment, read in conjunction with the appended drawings, in which:
- Figure 1 is a view illustrating a treatment session with the device of the present invention;
- Figure 2 is a diagram showing the components of an embodiment of the device of the invention;
- Figure 3 shows graphs illustrating the operation of the device according to the invention; and
- Figures 4 and 5 are diagrams showing variants of the present invention.

 Referring to Figure 1, the embodiment of the device according to the invention is presented externally as a portable housing 2 connected to an electrocardiograph electrode 4 and to a pneumatic cuff 6 via a flexible pipe 8 .

In service, the electrode 4 is placed on the patient's body 10 to detect the electrocardiogram signals, and the pneumatic cuff 6 is placed around the patient's member 10 to receive the treatment by pressotherapy.

 On the housing 2, are accessible a control button 12 and a reader 14 receiving in service a removable information medium 16 which, in the example shown, is a magnetic disk (floppy disk).

 The device is illustrated in more detail in the diagram of Figure 2. A processor 18 is mounted to control the pneumatic means connected to the cuff 6 according to the electrical signals from the electrocardiograph electrode 4 and predetermined instructions from the magnetic disc player 14.

 To process the electrical signals measured by the electrode 4, and transform them into a series of pulses translating the pulses R of the electrocardiogram of the patient 10, an amplifier 22, a low-pass filter 24, a band-pass filter 26 , a comparator 28 and an analog-digital converter 20 are connected in series between the electrode 4 and the processor 18.

 A compressor 30 pressurizes the content of an air tank 32, the outlet of which is connected to a non-return valve 34 with the interposition of a leakage valve 36, the leakage rate of which is electrically controlled by an outlet from the processor 18 to adjust the pressure of the air leaving the reservoir 32 towards the non-return valve 34. The outlet of the non-return valve 34 is connected to a solenoid valve 38, the non-return valve 34 being mounted so as to allow air passage only from the pressurized tank 32 to the solenoid valve 38. The pipe 8 connected to the pneumatic cuff 6 is also connected to the solenoid valve 38, the position of which is controlled by a power relay 40 as a function of control signals from the processor 18 In a first position (shown diagrammatically in FIG. 2), the solenoid valve 38 places the cuff 6 and the pipe 8 in communication with the atmosphere, and in a second position (not shown) the electrova nne 38 puts the pipe 8 and the cuff 6 in communication with the outlet of the non-return valve 34, and therefore with the pressurized air tank 32, so that the pressure adjusted by the leak valve 36 is applied to the pneumatic cuff 6.

 We will now describe the operation of the device according to the invention, with reference to FIG. 3. Graph b represents the electrocardiogram (ECG) reflecting the patient's heartbeat. This electrocardiogram is measured by the electrode 4 applied to the patient's body and then treated to extract pulses R corresponding to the successive maxima of the electrocardiogram, that is to say the cardiac systoles. Amplifier 22 amplifies the signal detected by electrode 4, then the low-pass filter 24 eliminates high-frequency noise from the output signal of amplifier 22, then the band-pass filter 26 eliminates noise that may exist at the frequency from the sector (50 Hz). The filtered signal, which has the appearance of curve b in FIG. 3, is sent to the input of comparator 28 which compares its level with a threshold E to deliver impulse signals at each pulse R of the electrocardiogram (see graph a in figure 3). This pulse signal is put in digital form by the analog-digital converter 20 then sent to the processor 18 which uses it to clock the operation of the device.

 The processor 18 controls the leak valve 36 and the power relay 40 to apply pressure pulses to a part of the patient's body 10, on which the pneumatic cuff 6 is placed.

Between two pulses R of the electrocardiogram, occurring at two instants t0 and t'0, a pressure pulse is applied in the cuff 6, between instants t2 and t4. To this end, the processor 18 supplies the power relay 40 between the instants t2 and t3 so that the solenoid valve 38 connects the cuff 6 and the pressurized air tank 32, the maximum pressure Pmax inside the cuff 6 being adjusted by a control of the leakage valve 36 by the processor 18. The pressure pulse has a trapezoidal profile illustrated in graph b of FIG. 3, the rising part corresponding to the pressure increase inside of the cuff 6 and the downward portion corresponding to the pressure drop in the cuff 6 after it is vented by the solenoid valve 38 at time t3 and before the atmospheric pressure in the cuff 6 is restored to the instant t4. The delay t2-t0 between each pulse R of the electrocardiogram and the start of the corresponding pressure pulse, the duration t3 - t2 supply of the relay 40 by the processor 18 (fixing the duration t4 - t2 of the pulse pressure) and the maximum value Pmax of the pressure pulse are predetermined adjustment parameters written on the magnetic disk 16 and addressed to the processor 18 via the reader 14.

 These adjustment parameters are generally defined by the attending physician during a prior diagnostic session. During this preliminary diagnostic session, the doctor visualizes a patient's sphygmogram, recorded in the area to be treated, in synchronism with his electrocardiogram.

This display can for example be carried out by means of a known device such as that marketed under the name Syncardon. Graphs representing the patient's electrocardiogram and sphygmogram are shown in b and c in Figure 3, respectively. The doctor can diagnose arterial disease when the lobe representing each pulsatile wave in the sphygmogram presents a deformation compared to an ideal profile corresponding to a healthy individual, or when the instant t1 corresponding to the maximum of the pulsatile wave has an excessive offset relative to the instant t0 of the corresponding pulse R of the electrocardiogram.

To prescribe pressotherapy treatment, the doctor then defines the number of treatment sessions that the patient will have to administer, the duration of each of these treatment sessions, the value of the delay t2-t0 having to occur between each pulse R of l electrocardiogram and the corresponding pressure pulse applied to the cuff 6, the supply duration t3-t2 fixing the duration t4 - t2 of this pressure pulse as well as the maximum value Pmax of the pressure applied. These different predetermined instructions are then written on the magnetic disc 16, which the patient can take to his home with a device according to the invention to administer the treatment sessions.

Values representative of the order of magnitude of the adjustment parameters are as follows
Pmax ranging from 4,000 to 7,000 kPa adding to atmospheric pressure; t2 such that the interval t2 - tl corresponds to approximately one third of the duration D of the falling part of the pulsatile wave (a few tens of milliseconds); duration t3 - t2 of the order of two thirds of the duration D of the falling part of the pulsatile wave.

 During the treatment session, the user turns on the device according to the invention, installs the electrocardiograph electrode 4 and the pneumatic cuff 6, and introduces the magnetic disc 16 into its reader 14. Once installed, it activates the control button 12 to trigger the actual processing. The predetermined instructions are read by the reader 14 and addressed to the processor 18 to adjust the synchronized control of the applied pressure pulses. The processor 18, which is connected to a clock 42 interrupts the treatment after the duration of the treatment session written on the magnetic disc has elapsed. It also verifies that the number of prescribed treatment sessions, which also appears on the magnetic disc 16 was not exceeded. The operation of the device can also be interrupted by a new actuation of the control button 12 by the user.

During the processing, the processor 18 also determines the periodicity t'0 - t0 of the pulses
R which it receives from the analog-digital converter 20.

Depending on this periodicity, it defines a maximum duration Dmax of the pressure pulse. The supply duration of relay 40 is then chosen as the smallest value between the prescribed duration read from the information medium 16 and this maximum duration Dmax.

Typically, the maximum duration Dmax will be equal to the difference between the periodicity t'0 - tO and the prescribed pulse delay t2 - tO. By thus delimiting the duration of the pressure pulse, it is avoided that it can result in an undesirable tourniquet effect resulting from the application of the pressure at inappropriate times.

 The device according to the invention makes it possible to apply pressotherapy treatments without requiring the presence of a doctor during the treatment sessions. The user does not however have the possibility of defining himself the parameters of the treatment which he will administer. To this end, the predetermined instructions can be written on the magnetic disk 16 in coded form, the processor 18 being then provided for decoding these instructions. It is also possible to use a reader 14 and a magnetic disc 16 of an unusual format to prevent the user from being able to define treatment parameters himself.

In other embodiments of the invention, the removable information medium 16 can also consist of a magnetic strip, a magnetic card or the like.

 As the device according to the invention is transportable, it is very suitable for application in patient treatment at home.

 Embodiments of the present invention other than those described with reference to Figures 1 and 2 are possible. In particular, the information medium used to convey the predetermined instructions can have different forms. In this regard, two examples of variants are illustrated in FIGS. 4 and 5.

 In the embodiment shown diagrammatically in FIG. 4, the information medium used is a telephone network T. The device then comprises a modem 44 connected to the processor 18 and replacing the reader 14. The modem 44 is connected in service to a telephone set 46 itself connected to the telephone network T by a socket 48. This embodiment of the present invention operates by connecting via the telephone network T to a server center placed under the responsibility of the doctor to receive the predetermined instructions useful for processing.

 In the embodiment shown diagrammatically in FIG. 5, the predetermined instructions for processing are written to a backed-up random access memory (RAM) 50 connected to the processor 18 via a controller circuit 52 acting as input means for predetermined instructions. The processor 18 is also connected to an alphanumeric keyboard 54 accessible to the user so that he can compose a code. The code thus composed is compared by the processor 18 to a predefined code registered in the memory 50, and the processor 18 controls the operation of the device only if the code composed on the keyboard 54 conforms to that registered in the memory 50. The device shown in FIG. 5 must be programmed by the doctor or by an authorized person before the treatment sessions, to write the predetermined instructions and the use code in the memory 50.

Claims (11)

 1. Device for promoting blood circulation in the body of a patient (10), comprising means (4) for detecting the patient's heartbeat (10), means (6) for applying periodic pressure pulses to a at least part of the patient's body (10) and control means (18) for adjusting the pressure pulses in correspondence with the cardiac pulses according to predetermined instructions during at least one treatment session, characterized in that comprises input means (14; 44; 52) for reading the predetermined instructions on an information medium (16; T; 50) and sending them to the control means (18).  2. Device according to claim 1, characterized in that the input means comprise a reader (14) receiving in service a removable information medium (16) on which are written the predetermined instructions.  3. Device according to claim 1, characterized in that the input means comprise a modem (44) adapted for the reception of predetermined instructions via a telecommunication network (T).  4. Device according to claim 1, characterized in that the input means comprise a reading device (52) connected to a memory (50) in which the predetermined instructions are written.  5. Device according to one of claims 1 to 4, characterized in that the predetermined instructions include the delay (t2-t0) between each systolic pulse of the heartbeat and a corresponding pressure pulse.  6. Device according to one of claims 1 to 5, characterized in that the predetermined instructions include the maximum value (Pmax) of each pressure pulse.  7. Device according to one of claims 1 to 6, characterized in that the predetermined instructions include the duration (t3-t2) of each pressure pulse.  8. Device according to one of claims 1 to 7, characterized in that the predetermined instructions include the duration of the treatment session.  9. Device according to claims 1 to 8, characterized in that the predetermined instructions include the number of treatment sessions that the patient (10) must undergo.  10. Device according to one of claims 1 to 9, characterized in that it comprises means for determining the periodicity (t'0-t0) of the patient's heartbeats and for defining as a function of this periodicity (t ' 0-t0) a maximum duration (Dmax) of each pressure pulse.  11. Device according to one of claims 1 to 10, characterized in that it is transportable.