ITRM20120471A1 - METHOD AND APPARATUS FOR PLANTAR STIMULATION - Google Patents

Description

DESCRIPTION

"Method and apparatus for plantar stimulation"

Field of the invention

The present invention relates to a method and an apparatus for plantar stimulation.

Known art

The most common therapies for arterial hypertension are drug therapies based on the intake of drugs, aceinhibitors, sartans, beta-blockers and thiazide diuretics, in addition to others and the combination of these.

These drugs, which must be taken continuously, are addictive and can cause severe side effects.

The need is therefore felt for a treatment of arterial hypertension, which is substantially free of side effects.

Summary of the invention

The inventors have found a surprising lowering of systolic and diastolic blood pressure in patients suffering from arterial hypertension, following a treatment of controlled and localized mechanical stimulation of the foot. The stimulation, in particular, is localized in correspondence with an area of the sole of the foot which substantially corresponds to the head of the metatarsus of the big toe, that is to say of the first metatarsal, possibly in combination with a stimulation of the head of the big toe itself.

The stimulation is carried out according to predetermined parameters including at least the intensity of the mechanical stimulation, the sequence of mechanical stimulations of said parts of the foot, the duration over time of each phase of mechanical stimulation and, optionally, the repetition of the sequence for a defined number of cycles.

The stimulation preferably affects both the right foot and the left foot. More specifically, an aspect of the invention consists of a treatment comprising the following mechanical stimulation phases, to be carried out sequentially or simultaneously:

a) an area under the sole of the left foot corresponding to the head of the metatarsal of the left big toe;

b) an area under the sole of the right foot corresponding to the head of the metatarsus of the right big toe;

and eventually:

c) of the head of the left big toe;

d) of the head of the right big toe.

The term "mechanical stimulation" means the achievement of an operating pressure, corresponding to the warning of the "stimulus" threshold by the patient. Said threshold is defined, for the purposes of the present invention, as stimulus or annoyance threshold. The correct working pressure must be determined case by case, as it varies according to the clinical picture of the patient and in particular the age, and the state of the hypertensive disease affecting the patient, as well as the subjective sensitivity. Generally, the achievement of the stimulus threshold corresponds to the manifestation of the patient's reflex to retract the leg or foot. It has been found that by using punches, or contact organs, with a spherical head from 1 - 2.5 mm in diameter for the mechanical stimulation, the force imparted to the punch necessary to reach said operating pressure is normally between 0.5 kgp and 2.5 kgp, i.e. between about 4.9 N and 24.5 N; however, a more or less intense stimulation can be adopted, remaining within the scope of the invention, on the basis of the subjective characteristics of the patient.

The treatment can also be performed manually, but is preferably automated by a series of stimulators each equipped with an organ in contact with the foot, for example a blunt tip.

The sequence preferably comprises the phases of stimulation of said areas of the right and left feet in the order a), b), and possibly c) and d), obtaining a mechanical stimulation, in the order, of: head of the metatarsal of the left big toe , metatarsal head of the right big toe, head of the left big toe, head of the right big toe. However, this order is not to be understood in a limiting sense of the present invention. The stimulation of the foot according to the invention can comprise any succession of the stimulation on the parts of the foot defined above. For example, you can follow the reverse order from d) to a), or any other.

More preferably, the treatment sequence is such that the aforementioned areas of the body are stimulated individually. This means that in any instant of the treatment, the mechanical stimulation is equal to or greater than the working pressure (or threshold) defined above in only one of the areas affected by the treatment, for example the area a), b), c) or d). The "dead time" that elapses between the interruption of the stimulus in one zone, for example the zone a), and the reaching of the operating pressure in the next zone, for example the zone b), is preferably less than 2 seconds.

The duration and number of cycles can also be determined according to the patient's overall clinical picture. In patients with arterial hypertension, optimal results were obtained with a duration of each stimulus between 3 and 10 seconds. Furthermore, the stimuli impressed on such patients preferably have substantially the same duration.

A further aspect of the invention consists of an apparatus for use in the treatment of arterial hypertension. The apparatus can be made according to various variants from the constructive point of view, which are not essential for the purposes of the invention. For example, the apparatus may comprise two devices applicable respectively to the right and left foot of the patient, or two housings for the feet, equipped with the necessary mechanical stimulation devices, and a suitable control system.

According to a possible embodiment, an apparatus for plantar mechanical stimulation is provided comprising at least a first mechanical stimulator positioned to operate, during use, on an area located under the sole of the foot and corresponding substantially to the head of the metatarsal of the foot. big toe and preferably also a second mechanical stimulator positioned to operate, during use, on the head of the big toe; the apparatus further comprises a control system adapted to operate said mechanical stimulators according to a treatment program comprising at least one mechanical stimulation intensity, a predetermined sequence of stimulation of said parts of the foot in both feet, a determined and possibly adjustable duration of each phase of mechanical stimulation, and optionally a repetition of said sequence.

According to a more preferred embodiment, an apparatus is provided comprising a first, a second, a third and a fourth mechanical stimulator in which: the first mechanical stimulator is positioned to act, during use, in an area under the plant of the left foot corresponding to the head of the metatarsal big toe of a patient; the second mechanical stimulator is positioned to act during use, in an area under the sole of the right foot corresponding to the head of the metatarsus of the big toe; the third mechanical stimulator is positioned to act, during use, on the head of the left big toe; the fourth mechanical stimulator is positioned to act, during use, on the head of the right big toe; and moreover the control system is predisposed for the activation of the stimulators.

Preferably, the control system is arranged for the sequential actuation of said first and second, and possibly also third and fourth stimulators, causing mechanical stimulation according to the predetermined sequence of the body areas a), b), and possibly c ), d) defined above.

The apparatus preferably comprises suitable adjustment means for positioning the stimulators in correspondence with the areas of the foot or feet involved in the treatment, for example the aforementioned areas a), b), and possibly c), d). The apparatus, moreover, preferably comprises suitable means for fixing to the foot for maintaining the correct position during the treatment, for example belts with adjustable fasteners or the like.

The stimulators can be made with a technique known per se and according to various forms, which are not essential for the purposes of the invention. In a preferred embodiment, a stimulator is substantially formed by a motor which, by means of a rotating shaft and a screw-screw coupling, causes the translation of an actuator. The motor-actuator unit is mounted on adjustable supports. The power supply is preferably low voltage (6-12 V) or battery.

Further construction features such as the use of hypoallergenic materials, easily washable, etc. and which are evident to the person skilled in the art will be provided on the basis of the law and contingent needs.

The control system preferably comprises at least a processing unit, an internal memory unit and a data interface with the outside, of a type known per se, such as for example a USB socket, network socket, wireless connection, or equivalent for transmitting and receiving data. Said interface can be mono or bidirectional. This interface can be used in particular to load a specific program for the patient, developed by a specialist. According to further variants, the apparatus can be controlled by a computer or by an external control unit. The control system can also comprise a "historical" recording function of the treatments on a suitable storage medium.

The methods of treatment may include the following steps. The first step consists in the determination, by a specialist, of the most appropriate treatment parameters for the specific patient, in particular: detection of the patient's stimulus threshold and determination of the force and / or stroke of the actuators to reach the correct pressure exercise; determination of the time duration of each individual stimulation and of the number of cycles for each treatment session. The specialist, therefore, can elaborate a set of treatment parameters, for example with the help of a suitable software program, and transfer them to the control system of the apparatus object of the present invention. The device therefore becomes usable at home directly by the patient or by a person who assists him, without the need for any medical specialization, since it works with a pre-loaded program.

The treatment, based on a purely mechanical stimulation of selective areas of the foot, does not have the contraindications and side effects of a pharmacological treatment; it is freely repeatable and shows no side effects.

A further important advantage of the invention is that the treatment does not require either hospital facilities or qualified personnel. The apparatus that carries out the treatment is constructively simple and essentially requires only the power supply, which can be supplied from the mains or even from batteries. The use of the apparatus and the implementation of the treatment are also possible in the home, with obvious advantages from the point of view of patient autonomy. The specialist's contribution is limited to the definition of the treatment parameters, which can be periodically updated and "loaded" into the internal memory of the control system; normal use is basically within everyone's reach, thanks to the fact that the treatment parameters are pre-set and stored in the machine.

Another advantage is the low cost, especially in relation to the obtainable benefits, which makes the treatment accessible to almost everyone.

The characteristics and advantages of the invention will become clearer with the following detailed description and with the aid of the attached figures.

Brief description of the figures

Fig. 1 schematically shows a stimulation apparatus according to an embodiment of the present invention.

Fig. 2 schematically shows the apparatus of Fig. 1 applied to the feet of a patient. Fig. 3 shows a possible trend of the stimulation intensity curves over time. Fig. 4 schematically shows the tip of a device of the apparatus referred to in Figures 1 and 2, suitable for plantar stimulation.

Fig. 5 shows the summary data of the analyzes carried out, in which:

- Table 1 shows the average values of the readings taken for each patient, whose sex and age are indicated, in a lying position relating to maximum pressure (SAP), minimum pressure (DAP) and heart rate (HR); these data refer to the recordings in the “basal” condition (ie pre-stimulation), and to the recordings in the “post-stimulation” condition, made 24 hours after the basal recording and after the stimulation;

- Table 2 shows the mean values of the variations recorded in the post-stimulation with respect to the basal condition relating to all patients;

Table 3 shows the mean values of the changes recorded in the post-stimulation compared to the basal condition relating only to the patients who showed a reduction in the maximum pressure (SAP) in the post-stimulation; these data therefore refer to n. 11 of n. 15 patients analyzed.

Detailed description of a preferred embodiment

With reference to the accompanying figures, 10 indicates an apparatus comprising two devices IR, IL applicable to the right foot RF and the left foot LF of a patient respectively. The devices IR, IL each comprise an anatomic support base 2R, 2L, for supporting the foot, where two stimulators 3R, 4R, 3L, 4L are positioned respectively in an anterior area and in an intermediate area of said support base 2R, 2L. When the devices IR, IL are correctly secured to the feet RF, LF in the position of use, the stimulators 3R, 3L are able to cause a mechanical stimulus on the head of the big toes, while the stimulators 4R, 4L are able to act on an area of the soles of the feet which substantially corresponds to the metatarsal head of the big toes.

The support bases 2R, 2L are each formed by a main support portion 6R, 6L, from which a front support portion 7R, 7L extends upwards. The main support portions 6R, 6L and the front support portions 7R, 7L are respectively designed to allow the soles and toes of the feet of a patient to rest.

The stimulators 3R and 3L are arranged on the top of the front support portions 7R, 7L and comprise respective actuators, or contact members, 8R, 8L each facing the corresponding support base 2R, 2L. The stimulators 4R and 4L are, on the other hand, placed under the support bases 2R, 2L and comprise respective actuators, or contact members, 9R and 9L enabled to protrude from corresponding openings 1 IR, 1 IL obtained in said support bases 2R, 2L. The aforesaid actuators 8R, 8L, 9R, 9L have an adjustable position with suitable means known per se (for example locking screws) and are each enabled to move according to a linear direction.

Further characteristics, by way of example, are the following. Each of the stimulators comprises a small electric motor with a rotating shaft which drives the respective actuator. The actuator is formed by a screw with an internal milling designed to be housed on the shaft itself. The organ intended for contact with the foot is obtained, for example, from a solid bronze rod, with an internal thread suitable for engaging the screw, and turned with a rounded tip to act as a stimulator. The base of said bronze stimulator has two protrusions which act as a bottom course; the whole is guided by a Teflon guide which ensures accuracy and simplicity of execution to the actuator. The tip of the actuator protrudes from the containment cage by 0 to 20 mm.

The devices IR, IL can be secured to the feet RF, LF, during the treatment, with closures of a known type.

According to further embodiments of the invention, the apparatus 10 comprises only one of the above-described IR devices, IL.

The apparatus 10 is equipped with a control unit 5 adapted to control the mechanical stimulators 3R, 4R, 3L, 4L, positioned to act on the areas of the foot affected by the treatment. The first 4R stimulator acts in an area under the sole of the right foot RF corresponding to the head of the metatarsal of the right big toe; the second 3R stimulator acts on the head of the big toe of the right RF foot; the third stimulator 4L acts in an area under the sole of the left foot LF corresponding to the head of the metatarsal of the left big toe; the fourth stimulator 3L acts, instead, on the head of the big toe of the left foot LF.

The control unit 5 controls the stimulators according to a predetermined treatment program, which can for example be contained in an internal memory of the same control unit 5. The control unit 5 is also equipped with at least one communication port with the external, according to a standard preferably chosen from the most widespread in the IT field (for example USB), to allow loading of the treatment program. In various embodiments, connection ports can also be provided remotely, for example network connections or equivalent, according to the known art and contingent needs.

An example of the activation logic of the stimulators as a function of time t is given in Fig. 3. The intensity of the stimulation can be expressed in terms of the force F exerted by the actuators 8R, 9R, 8L, 9L of the stimulators 3R, 4R, 3L , 4L. In order to obtain an effective result, this force must exceed a variable Fs threshold according to the patient's condition, which corresponds to the annoyance or stimulus threshold, in which the patient manifests the involuntary reflex to retract the foot.

Curve A of Fig. 3 refers to the activation of the first stimulator 3R in charge of stimulating the head of the right big toe. The stimulator motor takes a transient time to reach a preset work intensity, equal to or slightly higher than the threshold value Fs. This intensity is maintained from a stimulus start instant tf to a stimulus end instant tf, for a duration of the single stimulus d typically of a few seconds, for example 6 seconds.

The rising "ramp" of curve A corresponds to the time it takes physically by the actuator of the 3R stimulator to touch the head of the big toe and reach the desired pressure. This time can for example be less than 1 second. At the end of the treatment, the stimulus intensity (curve A) decreases rapidly. Curve B shows the intervention of the next stimulator according to the preset sequence, for example the 4R stimulator which acts on the head of the metatarsus of the right big toe. As can be seen, the stimulator 4R is preferably operated at the same time as the stimulus end instant of the stimulator 3R.

In this way, the ramp of rise of curve B overlaps the ramp of descent of curve A, and the dead time of absence of stimulus is reduced.

The same control logic is repeated at the instant of activation of the stimulators 4L and 3L. The sequence is then repeated cyclically, for a variable number of cycles, for example 4 cycles. The overall duration of the treatment can therefore be a few minutes, for example 2 minutes.

It must be understood that the constructive characteristics are widely variable and therefore may be subject to variations according to the application of the known technique.

TREATMENT

Fifteen patients were treated, 8 male and 7 female, mean age 65 years, for each one at least 10 pressure recordings spaced 2 minutes apart during lying position (REST) were made. The data reported are the average of the readings and indicate the maximum pressure (SAP), minimum pressure (DAP), and heart rate (HR). The recordings were made in basal conditions (pre-stimulation) and repeated 24 hours after the stimulation (which occurred in the minutes following the basal recordings).

The data therefore refer to approximately 600 records.

Data from lying position recordings (REST) were analyzed.

What emerges from the recordings made is the following:

1) On average, the maximum pressure (SAP) in the lying position (REST) after stimulation is lowered by 7.2 lines of mercury with a standard deviation equal to 3.1 lines of mercury; in particular in patients in which the stimulation is effective in reducing the maximum pressure (SAP), or in 11 cases out of 15, the maximum pressure is lowered on average by 12.5 lines of mercury with a standard deviation equal to 2.6 lines of mercury.

The treatment (delivered via device) stimulates one or both points of the plantar surface of the foot in correspondence with the head of the 1st metatarsal (see attached image) or the head of the big toe, in one or both feet, simultaneously in the various points or in sequence.

Stimulation is mechanical and is performed with a device with a tip (see Fig. 4) having a diameter between 1 and 2.5 mm, preferably but not limited to 1.65 mm, which acts with a force between 0.5 kgp and 2.5 kgp.

The data shown in Fig. 5 show that, on a sample of 15 patients, stimulation had a positive effect in 73% of cases (11 out of 15 patients), having allowed, in patients who showed a positive response to therapy, to reduce the maximum pressure (SAP) averaged 12.5 mercury lines 24 hours after stimulation, with a standard deviation in the group under examination equal to 2.6 mercury lines. This variation is significant for the percentage of patients who responded positively, and for the extent of the average improvement obtained.

Claims (21)

CLAIMS 1. Method for plantar stimulation of a subject, including multiple controlled mechanical stimulations located in an area under the sole of the foot corresponding to the head of the metatarsal of the big toe; said method being operated according to predetermined parameters comprising at least: a predetermined intensity of the mechanical stimulation, a predetermined sequence of the stimulation of the identified points, a predetermined duration of each mechanical stimulation. 2. Method according to claim 1, further comprising several controlled and localized mechanical stimulations to the head of the big toe. Method according to claim 1 or 2, comprising mechanical stimulations of: a) an area under the sole of the left foot corresponding to the metatarsal head of the left big toe, b) an area under the sole of the right foot corresponding to the metatarsal head of the right big toe, and, optionally, c) head of the left big toe, d) head of the right big toe. Method according to claim 3, wherein the mechanical stimulations are performed simultaneously. 5. Method according to claim 3, in which the mechanical stimulations are performed in the order a), b), c), d) or b), a), d), c). 6. Method according to any one of claims 1 to 5, in which said mechanical stimulations cause the achievement of an operating pressure or threshold pressure, corresponding to the warning of a stimulus by the subject. Method according to claim 6, wherein each mechanical stimulation is performed by means of a spherical tip punch having a diameter of between 1 and 2.5 mm. Method according to claim 6 or 7, wherein each mechanical stimulation is performed by applying a force between 0.5 kgp and 2.5 kgp. Method according to any one of the preceding claims, wherein each mechanical stimulation has a duration of between 3 and 10 seconds. Method according to claim 9, wherein the mechanical stimulations have a duration substantially equal to each other. 11. Apparatus for plantar stimulation, said apparatus comprising a first mechanical stimulator (4R) able to operate, during use, on an area located under the sole of a foot (RF) and corresponding substantially to the head of the metatarsus of the big toe ; said apparatus further comprising a control system (5) adapted to actuate said first mechanical stimulator (4R), for use in the treatment of a subject who needs a lowering of the arterial pressure. 12. Apparatus according to claim 11, further comprising a second mechanical stimulator (3R) able to operate, during use, on the head of the big toe of the foot (RF); said control system being able to actuate also said second mechanical stimulator (3R). Apparatus according to claim 11 or 12, comprising said first mechanical stimulator (4R), said second mechanical stimulator (3R), a third mechanical stimulator (4L) and a fourth mechanical stimulator (3L), wherein: - said first mechanical stimulator (4R) is arranged to act, during use, in an area under the sole of a patient's right foot (RF), corresponding to the metatarsal head of the big toe; - said second mechanical stimulator (3R) is arranged to act, during use, on the head of the big toe of a patient's right foot (RF); - said third mechanical stimulator (4L) is arranged to act, during use, in an area under the sole of a patient's left foot (LF), corresponding to the head of the metatarsal of the big toe; - said fourth mechanical stimulator (3L) is arranged to act, during use, on the head of the big toe of a patient's left foot (LF); and in which the control system (5) is set up for the operation of said first, second, third and fourth mechanical stimulators (4R, 3R, 4L, 3L). 14. Apparatus according to claim 13, in which said control system (5) is designed to obtain the activation, in sequence, of said third, first, fourth and second mechanical stimulators (4L, 4R, 3L, 3R). 15. Apparatus according to claim 13 or 14, wherein said control system (5) is arranged to regulate the rationing of each of said mechanical stimulators (3R, 4L, 4R, 3L) to obtain the achievement of a certain threshold pressure. 16. Apparatus according to claim 15, wherein said control system (5) is arranged to control said mechanical stimulators (4L, 4R, 3L, 3R) in sequence, so that said stimulators reach said threshold pressure in sequence, maintaining it for a determined time, and in such a way that, at any instant, only one of said stimulators reaches said threshold pressure. Apparatus according to any one of claims 11 to 16, wherein each mechanical stimulator comprises a contact member (8R, 8L, 9R, 9L) enabled to move in a linear direction and connected to actuator means for the relative actuation; said contact member (8R, 8L, 9R, 9L) having a rounded or substantially spherical head for contact with a foot. 18. Apparatus according to claim 17, wherein said head has a diameter between 1 mm and 2.5 mm and said control system (5) is arranged to impress on a foot, through each contact member, a stimulating force between 0.5 kgp and 2.5 kgp. Apparatus according to any one of claims 11 to 18, wherein said control system (5) comprises at least one one-way or two-way data communication port. 20. Apparatus according to any one of claims 13 to 19, comprising a first device (IR) for the treatment of a right foot (RF) and a second device (IL) for the treatment of a left foot (LF), said first mechanical stimulator (4R) and said second mechanical stimulator (3R) being associated with the first device (IR), and said third mechanical stimulator (4L) and fourth mechanical stimulator (3L) being associated with the second device (IL). 21. Apparatus according to claim 20, wherein each of said first device (IR) and second device (IL) comprises a support base (2R, 2L) comprising a main support portion (6R, 6L), to allow the support of the sole of a foot (RF, LF), and an anterior support portion (7R, 7L) extending from said main support portion (6R, 6L) upwards and adapted to allow the support of the big toe of the foot (RF, LF); said first mechanical stimulator (4R) being arranged under the support base (2R) for the right foot (RF) in correspondence with an opening (1 IR) obtained in said support base (2R); said second mechanical stimulator (3R) being arranged at a top of the front support portion (7R) of the support base (2R) for the right foot (RF); said third mechanical stimulator (4L) being arranged under the support base (2L) for the left foot (LF) in correspondence with an opening (11L) obtained in said support base (2L); said fourth mechanical stimulator (3L) being arranged at a top of the front support portion (7L) of the support base (2L) for the left foot (LF).