WO2015144952A1

WO2015144952A1 - Device for treating tendinopathies and fibrillar ruptures

Info

Publication number: WO2015144952A1
Application number: PCT/ES2015/070123
Authority: WO
Inventors: Emilio GARCIA CARBONELL; Vicente ALEPUZ MONER
Original assignee: Ionclinics & Deionic, S.L.
Priority date: 2014-03-24
Filing date: 2015-02-24
Publication date: 2015-10-01
Also published as: ES2546651A1; ES2546651B1

Abstract

The invention relates to a device for treating tendinopathies and fibrillar ruptures, comprising a current-generating means (1) with direct current (1.a) and alternating current (1.h) generators and systems for controlling and processing the signals thereof, and respective electrodes for contact with the patient, one of said electrodes being a positive surface electrode (4). The device can comprise a module (1.g) for calibrating the applicable current intensity, which emits a pulsating signal or a continuous signal in the form of a staircase, both with an increasing current level, in order to determine the pain threshold of the patient.

Description

DESCRIPTION

DEVICE FOR RECOVERY OF FENDER TENDINOPATHIES AND BREAKS

SECTOR OF THE TECHNIQUE

The present invention relates to a device for the treatment of tendinosis, commonly called chronic tendonitis, and for the treatment of fibrillar tears, through percutaneous electrolysis.

STATE OF THE TECHNIQUE

Tendinosis is an accumulation of small lesions or overloads of the tendon and the surrounding structures (paratendon and synthesis) at the cellular level, this implies a pathology of chronic degeneration without inflammation.

Fibrillar rupture is a tear or rupture suffered in a muscle or tendon (tissue that inserts the muscle with the bone). When a tear occurs, the muscle or tendon ruptures.

Inflammation is a tissue process consisting of a series of molecular, cellular and vascular phenomena of defensive purpose against physical, chemical or biological aggressions.

The present invention aims to generate a painless inflammation of the tissue affected by tendinosis or fibrillar rupture favoring the recovery of the affected tissue.

The present invention is intended to provide a technical solution for the effective treatment of tendinosis and fibrillar ruptures, by means of a novel easy-to-use device.

BRIEF EXPLANATION OF THE INVENTION

The invention consists of a device for treating tendinosis and fibrillary tears according to the first claim, and with the variants defined in the dependent claims.

Thus, the treatment device has a means of generating current that has a first generator, which is a direct current generator regulated by a current control system that limits the output intensity, and a second generator, which corresponds to an alternating current generator with two signal processes, all managed by a processing unit. The current generation medium will have of two terminals, a positive one (anode) to which a large surface contact surface electrode connects, and a negative terminal (cathode) to which several types of electrodes can be connected. First, the negative terminal may be connected to an electrode formed by a percutaneous metal needle assembly and its needle holder, or even by several such assemblies. Preferably, the generator start and stop button will be arranged on the support itself to be more accessible. A second variant incorporates a second surface contact electrode in the negative terminal of the current generating means.

It is advantageous that the current generating means comprise a module for calibrating the current intensity, to define the patient's pain threshold and thus optimize the treatment without causing more pain than necessary, to know the maximum intensity that the patient It is capable of enduring without pain, taking into account your pain threshold.

The device will also have two ammeters at each terminal, and a voltmeter between them, as safety measures that will deactivate the device if its measurements exceed a predefined threshold. Thanks to these elements, the processing unit will be able to know what real energy is being transmitted through the human body (impedance control, and input-output currents).

One of the main advantages of the invention is the use of direct and alternating current in the same equipment to perform all the complete therapy (Percutaneous electrolysis and electro stimulation with analgesic characteristics), all this without generating pain thanks to its maximum intensity calibration applicable, and to the control of the transmitted energy and load.

DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, the following figures are included.

Figure 1: functional diagram of the first phase of treatment.

Figure 2: Energy transfer function of the first phase of the treatment, in a graph where the pain zone (ZD), the painless zone and of medium stimulation (Zl) and the painless and low stimulation level (NI) have been marked ).

Figure 3: example of a form of pain threshold calibration signal. Figure 4: functional diagram of the second phase of the treatment.

Figure 5: standard signal for electro-stimulation.

Figure 6: Continuous signal for analgesic electro-stimulation.

Figure 7: signal with pulse width modulation for analgesic electro-stimulation. Figure 8: functional diagram of the first phase of the treatment with multiple needles. EMBODIMENTS OF THE INVENTION

Next, an embodiment of the invention will be briefly described as an illustrative and non-limiting example thereof.

The invention comprises a means for generating current (1) that emits a direct or alternating current signal, according to the method of operation, and two electrodes to place in the patient. The current generating means (1) will therefore have a direct current generator (1 .a) and an alternating current generator (1 .h).

The direct current generator (1. A) will be regulated by a current control system (1. B), which will allow to control the emitted signal. Similarly, the AC generator (1 .h) will have two processes (1 .i, 1 .j) of the output signal to obtain two different effects from the same alternating current.

The generator can be completed with safety systems (1 .c, 1 .d, 1 .e) consisting of ammeters (1 .c, 1 .d) that measure the current in the electrodes and a voltmeter (1 .e) that monitor the voltage difference between the two. If any of the measured values leaves the pre-marked safety range, the operation is stopped.

For this, the current generating means (1) comprises a processing unit (1 .f) with the control logic, which according to the marked treatment activates the appropriate current generator (1 .a, 1 .h) as well as Your processing or control. You can add a calibration module (1 .g) of the patient's resistance, which emits pulses of current or continuous signal in the form of a staircase both with an increasing current level, to know the appropriate current to each user according to their threshold of pain. The invention addresses the treatment of tendinosis or fibrillary rupture from two areas: biological treatment by means of percutaneous electrolysis and biomechanical treatment or eccentric work, because if we only treat the biological part and not the biomechanics, we will not obtain the results desired Therefore, the invention can be divided into three phases:

• First phase: Percutaneous electrolysis with an inflammatory purpose (Figure 1), beginning of the repair process.

• Second phase: Electro stimulation for an analgesic purpose (Figure 4), to reduce possible discomfort of the inflammatory process.

· Third phase: Eccentric exercises in order to regenerate the damaged area.

In the first phase, the first electrode can be a percutaneous metallic needle (2) located in a needle holder (3), and which will act as a negative electrode. This needle is inserted into the affected tissue (5.a) of the patient. In this phase, the positive electrode will be a large surface contact electrode (4), and the tissues (5) that lie between the two electrodes that act as electrolyte.

The needle (2) will be of stainless steel or other metallic material that has a low electrical resistance and of a variable thickness and length, depending on the type of lesion to be treated.

The needle holder (3) will be made of insulating material with ergonomic characteristics for correct puncture. Preferably it incorporates a button, capable of controlling the start and stop of the treatment, and another button (3.a), capable of controlling a micro motor that will rotate the needle, producing a subcutaneous tissue winding as well as strips of collagen bundles towards the periphery of it. It is compatible with most existing needles (2). It will be placed at the end of the negative terminal cable (6.a), which leaves the negative terminal of the current generator (1).

The surface electrode (4) will have a minimum surface area of about 2500 mm ² , and will be connected to the positive terminal cable (6.b), which goes from the positive terminal of the current generator (1) to the contact surface electrode (4 ). The direct current generator (1. A) will induce a charge circulation, through the electrolyte (tissue (5) between the two electrodes), between the electrode introduced into the affected tissue (Cathode) and the electrode that is in contact with the skin (anode). Due to the flow of current, a breakdown of the tissues in their basic substances (electrolysis) is generated, in addition to heating as a consequence of Ohm's law.

In the anode, electrode in contact with the skin, the most important reactions are:

2H ₂ 0 0 ₂ + 4H ⁺ + 4e ^"

2CI ^" Cl ₂ + 2e ^"

Therefore the main reaction is the decomposition of water, taking place a reduction of the pH in the proximity of the positive electrode.

In the cathode, electrode introduced in the affected tissue, the most important reactions are:

2 H ₂ 0 + 2 e ^" H ₂ + 20l-r

Therefore the main reaction is the decomposition of water, giving rise to hydrogen in the gaseous state and hydroxyl ions increasing the pH in the vicinity of the negative electrode.

The aforementioned effects, electrolysis and heating of the tissue, depend directly on the density of current in circulation and in turn the density of current depends on the current generated by the direct current generator (1 .a) and the contact surface of the electrode .

The electric current is the same for the anode and cathode but the surface in contact with the anode tissue is approximately 98% larger than the surface in contact with the cathode.

This implies that the effects of electrolysis and heating on the anode are negligible due to the low current density compared to the cathode.

Surface (S ') of a needle of dimensions 0.3mm radius (r) and 50mm in length (h).

S ': 2-TT-r-h + π -r ² = 47.19mm ²

Square surface electrode surface (S) of dimensions (I) 50 x 50mm S: l ² = 2500mm ²

The physiological effect on the tissue surrounding the cathode is an increase in pH, producing an aggression to the affected soft tissues and a subsequent inflammation necessary to initiate the repair process.

To achieve the desired effect, the ideal electric charge level is 25mC, which is the amount of total electric charge that the generator (1 .a) generates in each treatment in this phase.

To avoid pain due to an excess of electrical current that produces a neuro-muscular overstimulation, before carrying out the treatment, a calibration of the maximum current delivered by the direct current generator (1a) in this phase can be performed , depending on the pain threshold of the patient and the area to be treated.

Analyzing the definition of pain it is possible to understand the difficulty in measuring it, due to its subjective nature and its multidimensional nature. It is about objectifying a fundamentally subjective phenomenon, subject to great individual variability, and in which the patient himself is the best evaluating judge.

For this, the calibration module (1 .g) generates a pulse signal or continuous signal in the form of a staircase both with an increasing current level, for example a pulse signal of pulse width 250 ms and of periodicity 1 s where the level of Current increases gradually, until the patient indicates to the physician a subjective level of pain of 5 on a scale of 1 to 10 (Figure 3). This current value is what the processing unit (1 .f) will take in the control logic to calculate the energy transfer function and the current that the current control system (1 .b) will allow to produce. Normally the intensity will not exceed 500μΑ. From this maximum current, the processing unit (1 .f) calculates the duration of the treatment taking into account the optimum value of the necessary load, 25mC, to generate the desired inflammatory effect.

To avoid neuronal over-stimulation (pain) due to a sharp change in current density, the value of the current should be gradually increased until the treatment value calculated by the control logic is reached. According to the value of the current electrical is closer to the pain threshold, previously calibrated, energy increases should be smaller to avoid neuronal stimulation (pain sensation).

Therefore, the processing unit, apart from calculating the maximum treatment current and the duration time, calculates the double slope necessary for the increase of the electrical current until reaching the value of current density necessary for the treatment from a system of current control (1 .b), without generating a neuronal stimulation due to a sharp change in current density as shown in figure 2. Thus, the current control system (1 .b) allows to reach the intensity marked by the calibration progressively, in two successive sections, being the second section with the lowest slope.

In the case of fibrillar tears, because the damaged tissue may have a greater surface area, the application of the invention can be carried out by using several needles (2) attached to the same negative terminal through the corresponding supports (3) , reducing the density of electric current in each of them and increasing the treated surface. All this is shown in Figure 8.

Second phase: Transcutaneous electrical neuro-stimulation with an analgesic purpose, comprises two superficial contact electrodes (4, 8), superficially located on each side of the damaged tissue (5.a); an alternating current generator (1 .h) and the processing unit (1 .f) that executes the control logic, with the positive terminal also connected to the surface electrode (4), and the negative terminal connected to a second surface electrode (8), similar to the previous one, as shown in Figure 4. The electrical circuit in this second phase will consist of the alternating current generator (1 .h), the two surface electrodes (4,8) and the tissues (5 ) that are between the two electrodes that act as electrolyte.

The object of the second phase of the treatment with the invention is to apply a current on the skin intended to stimulate sensitive nerve fibers for an analgesic purpose.

For this, the alternating current generator (1 .h) generates a standard signal formed by two pulses of equal amplitude and duration but out of phase 180 ^e , so that the average value of the electric current is null, thus avoiding phenomena of electrolysis. The shape of the standard signal is shown in Figure 5. This generator can be applied to two different processes (1 .i, 1 .j) different from the output signal to achieve two different analgesic effects:

Continuous mode: It generates a train of continuous pulses of constant amplitude and width and calculated by the control logic from the pain threshold calibrated in phase 1. The pulse repetition frequency can be set from 50 to 100Hz and the pulse width from 50 to 150 microseconds, as shown in Figure 6.

Pulse width modulation mode: Generates a continuous pulse train of constant amplitude and calculated by the control logic from the pain threshold calibrated in phase 1. Likewise, the repetition frequency can be set from 50 to 100Hz, but the pulse width varies randomly between 50 and 150 microseconds, as shown in Figure 7. The current generators (1. A, 1. H) of Phase 1 and Phase 2 have two safety systems to ensure the correct operation of the treatment:

The first detects a leakage of current in the circuit formed by the means of generating current (1), electrodes (2 and 4 or 8 and 4 depending on the phase in which we are) and electrolyte tissue (5). The safety system measures the electric current flowing through the anode ammeter (1 .c) and the cathode ammeter (1 .d), said current must coincide in the correct operation of the system.

The signal differs from both currents if it exceeds the safety threshold level will cause the processing unit (1 .f) to stop the treatment.

The second system measures the potential difference between the electrodes, calculating the impedance present between the two. If the impedance exceeds the safety threshold impedance it will cause the control logic to stop the treatment.

Third phase: Eccentric exercises in order to regenerate the damaged area.

The described device can be used for the treatment of tendinosis and fibrillar ruptures by a method that will depend on the lesion. Therefore, it must start with the diagnosis of the pathology. Tendinosis:

Initially, clinical points (pain points) should be determined through an examination. The scan can be assisted through an ultrasound.

Once the pain points are defined, the superficial electrode, anode (4), is placed as close as possible to the injured area (5.a) and in the cranial direction.

The length and thickness of the needle (2) is selected depending on the type of tissue to be treated and the depth of the lesion.

Tendon puncture can be performed longitudinally in a caudal or cranial direction or transversely depending on the osteo-tendon lesion to be treated. This puncture can be echo-guided with the help of an ultrasound.

Once the puncture is performed, the needle (2) is rotated, producing a subcutaneous tissue winding as well as strips of collagen bundles towards the periphery of the needle (2).

Once both electrodes (needle (2) and surface electrode (4)) are placed, we proceed to perform the calibration, the equipment generates the calibration signal and the patient indicates to the doctor his pain threshold for the calibration of the maximum treatment current.

With the beginning of the treatment, the equipment generates direct current, whose value is increased until reaching the nominal value of the treatment, as shown in figure 2. If the damaged surface is large, it is possible to work on a puncture fan, that is, different punctures with different puncture angles without removing the needle completely.

Once the first phase of the treatment is finished: percutaneous electrolysis with an inflammatory purpose, the negative electrode (needle (2)) is removed and replaced by a second surface electrode (8), as shown in Figure 4, and executed the second phase, electro-stimulation with an analgesic purpose.

48 hours after receiving the treatment, estimated time of the acute phase of inflammation, we move on to the third phase, eccentric work.

In this phase the biomechanical treatment or eccentric work begins, since if we only treat the biological part (Phases 1 and 2) and not the biomechanics, we will not obtain the desired results. The regeneration and remodeling of the tendon is the mechanical part, the eccentric work will cause the fibroblasts to proliferate, the tenoblasts to synthesize more collagen, at a higher speed and with better orientation. The protein (tenacin) in the tendons, is activated with eccentric work around the collagen fibers and fibroblasts, especially in the musculoskeletal junction.

Eccentric exercises will be daily, until the start of a new treatment session. The periodicity of the treatment is weekly, with a maximum of 6 sessions. Fibrillary tears:

Fibrillary ruptures cannot be treated until 48 hours after the injury.

Initially the clinical points (pain points) are determined through an examination, which can be assisted through an ultrasound.

Once the pain points are defined, the superficial electrode (4), anode, is placed as close as possible to the injured area (5.a) and in the cranial direction. The length and thickness of the needle (2) is selected depending on the type of tissue to be treated and the depth of the lesion.

In the case of fibrillar ruptures, we can use the methodology explained above for the pathology of tendinosis, or the methodology of using several needles (2) attached to the same negative terminal, reducing the density of electric current in each of them and increasing the treated surface, as shown in Figure 8. Punctures with several needles (2) are performed perpendicular to the fibrillar rupture to be treated. Such punctures can be echo-guided with the help of an ultrasound. Once the punctures have been made, the needles (2) are rotated, producing a curl of the subcutaneous tissue as well as strips of collagen bundles towards the periphery of the needle (2).

Once both electrodes (needles and surface electrode) are located, we proceed to perform the calibration, the equipment generates the calibration signal and the patient indicates to the doctor his pain threshold for the calibration of the maximum treatment current. At the beginning of the treatment, the equipment generates direct current, the value of the current is increased until reaching the nominal value of the treatment, as shown in Figure 2.

Once the first phase of the invention, percutaneous for an inflammatory purpose, is finished, the negative electrodes (needles) are removed and a compressive bandage of the damaged area is performed.

A second surface electrode (8) is placed as shown in Figure 4, it is passed to the second phase, electro stimulation for an analgesic purpose.

In this phase the biomechanical treatment or eccentric work begins, since if we only treat the biological part (Phase 1 and 2) and not the biomechanics, we will not obtain the desired results.

The regeneration and remodeling of the tendon is the mechanical part, the mechanical stimulus, the eccentric work will cause the fibroblasts to proliferate, so that the tenoblasts synthesize more collagen and at greater speed and with better orientation. The protein (tenacin) in the tendons, is activated with eccentric work around the collagen fibers and fibroblasts, especially in the muscle-tendon junction.

Eccentric exercises will be daily, until the start of a new treatment session. The periodicity of the treatment is weekly, with a maximum of 6 sessions.

Claims

1 - Device for the recovery of tendinopathies and fibrillar ruptures, characterized in that it comprises a means of generating current (1) that has:

- a direct current generator (1 .a) regulated by a current control system (1 .b) that limits the output current;

- an alternating current generator (1 .h) with two processed (1 .i, 1 .j) of the signal;

- a processing unit (1 .f);

- a large surface surface electrode (4) connected to the positive terminal of the current generating means (1);

- an electrode in the negative terminal of the current generating means (1).

2- Device according to claim 1, characterized in that it comprises at least one percutaneous metal needle assembly (2) a needle holder (3) with a micro motor for rotating the needle, connected to the negative terminal of the means for generating current (1).

3- Device according to claim 2, characterized in that the support (3) has a button (3.a) configured to control the micro motor. 4- Device according to claim 1, characterized in that it comprises a second surface electrode (8) connected to the negative terminal of the current generating means (1) -

5- Device according to any of the preceding claims characterized in that it has two ammeters (1 .c, 1 .d) in the electrodes and a voltmeter (1 .e) between them.

6- Device according to any of the preceding claims, characterized in that it comprises a calibration module (1 .g) of the current intensity acceptable by the patient.

7- Device according to claim 6, characterized in that the calibration module (1 .g) generates a pulsating signal or continuous signal in the form of a staircase both with an increasing current level. 8- Device, according to claim 6 or 7, characterized in that the current control system (1 .b) produces the intensity marked by the calibration progressively, in two successive sections, the second section being the lowest slope. Device according to any of claims 6 to 8, characterized in that the processing unit (1 .f) calculates the operating time of the direct current generator (1 .a) to generate a load of 25mC with the maximum intensity acceptable.