ES2457668A1 - Device for the therapeutic treatment of musculoskeletal injuries (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Device for the therapeutic treatment of musculoskeletal injuries. This device comprises: a load control and management module (8), a direct current generator (dc) module (10) and a high voltage pulsed current generator (cpav) module (11) controlled by a microprocessor (9) ); a user interface (2) connected to a cpu (7); a display screen (3); and a positive electrode (4) and a maniple (5, 5a) needle holder (6, 6a) suitable for applying to the patient a direct current and a single phase pulsed current supplied by the respective modules (10, 11). The device comprises, connected to the microprocessor (9), a control driver (15) of a vacuum pump (14) suitable for applying a suction in the area of application of current by means of a specific needle (6a) for vacuum. (Machine-translation by Google Translate, not legally binding)

Description

Device for the therapeutic treatment of musculoskeletal injuries.

Object of the invention.

This invention relates to a device for the therapeutic treatment of musculoskeletal lesions, and especially in the treatment of soft tissue lesions (tendons, muscles, fascia, ...) that has characteristics oriented to apply directly on the affected area and using a needles

Field of application of the invention.

The device of the invention is applicable in the therapeutic field for the treatment of musculoskeletal injuries such as: chronic painful tendinopathies, symptomatic muscle fibrosis; chronic ligamentous lesions; chronic muscle injuries, treatment of trigger points in myofascial pain.

Background of the invention.

The treatment of the indicated lesions is currently known, by means of a technique developed by the owner of the invention, which consists in the application in the area to be treated of an adapted galvanic current (direct current), through an acupuncture needle that It acts as a negative electrode (cathode) and that by ultrasound control, causes an electrochemical reaction in the degenerated region of the tendon.

This technique performs a focused treatment of the site of the lesion in direct contact with the damaged tissue, which causes an approximation of the active cells to the induced lesion favoring healing.

The owner of the invention itself has already developed a treatment device comprising: a load management and control module for feeding the device, a direct current (DC) generator module controlled by a microprocessor and suitable for supplying a direct current to the patient.

This device comprises a user interface connected to a CPU for the selection of the characteristics and application time of the current to the patient; a display of the parameters of the treatment such as the selected current intensity (mA), set time of the application and energy supplied at the end of the treatment (Joules), which allows the application of the therapy simply and clearly by part of the therapist.

For the application of the current this device comprises: a positive electrode and a needle-holder handle suitable for applying the current to the patient by means of an external contact with positive electrode and the insertion in the area to be treated of a conductive needle connected to the handle and which allows the application of direct current (DC) in said specific area.

This device represents an important advance regarding the treatments used previously and based on the practice of specific exercises or the application in the area to be treated of shock waves, ultrasound, laser, heat or surgery, however it only allows the application of current It continues in the area to be treated, the objective of the present invention being the development of a device that substantially improves the effectiveness of the treatment and reduces the recovery time of the patient.

Description of the invention

The device object of this invention, being of the type mentioned above and developed by the same applicant, presents constructive particularities aimed at achieving the proposed purposes in terms of improving the treatment of soft tissue injuries (tendons, muscles, fascia. ..) and reduce the recovery time of the patient.

To achieve these objectives, a device has been developed that, in addition to allowing the application of direct current to the patient through an external positive electrode and a needle that is inserted into the patient, applying the current right in the area to be treated, presents constructive particularities oriented to allow the simultaneous or alternative application of a high voltage pulsed current and to carry out a specific control of the characteristics and times of the currents to apply both direct current (DC) and high voltage pulsed current ( CPAV) in order to increase the effectiveness in the treatment and avoid discomfort to the patient during said treatment due to an application at the beginning of the treatment of a current of excessive intensity.

Another object of the invention is the incorporation into the device of suitable means to perform a suction at the point of application of the current by means of the needle and to carry out the extraction during the treatment of the liquids produced by the treatment itself. the tendon or area to be treated.

To achieve the proposed purposes, this device comprises a control and load management module for feeding the device, a direct current (DC) generator module controlled by a microprocessor and suitable for supplying a continuous current to the patient; a user interface connected to a CPU for the selection of the characteristics and application time of the current to the patient; a display screen of the treatment parameters; a positive electrode and a needle holder handle suitable for applying the current to the patient in external contact with the positive electrode and the insertion of the needle into the area to be treated; this device presenting the particularity of comprising a high voltage pulsed current generator module (CPAV) provided with a pulse generator, controlled by the device microprocessor and suitable for supplying a pulsed current to the patient through the positive electrode and the needle holder. of high voltage in the form of a single-phase pulsed wave, in this invention it is provided that the pulsed high-voltage current (CPAV) is preferably carried out jointly with the direct current (DC) supplied by the corresponding generator module, allowing through a connector The polarity change.

This device, by incorporating the high voltage pulsed current generator module, allows an electrical stimulation with the mentioned pulsed current to be carried out during the treatment of the fabric with direct current producing positive effects among which a reduction of the healing time can be mentioned due to the attraction of the cell types appropriate to the area, the activation of said cells by altering the function of the membrane, the modification of the endogenous electrical potential of the tissue according to the healing potentials, reduction of edema, potentiation of the antimicrobial activity, promotion of circulation and healing.

In this regard it should be mentioned that both direct current and high voltage pulsed current applied by the device kill bacteria in vitro while alternating currents have no effect on the survival of microorganisms.

In accordance with the invention, the direct current generator module (DC) and the pulsed current generator module (CPAV) are connected to an intensity control module, suitable to allow microprocessor control of the current intensity supplied to the patient. preventing it from reaching ineffective or dangerous values for the patient.

In this regard and in accordance with the invention it is provided that the device is programmed to deliver a direct current and a pulsed current under specific conditions, which are especially indicated for the treatment and that avoid pain to the patient during the treatment.

Specifically, the device is programmed to supply direct current of an intensity comprised between 0.1 milliamps and 15 milliamps, with the option of being able to gradually increase up to said value of 15 milliamps for a maximum time of 30 seconds per intervention.

This progressive and adapted application of the direct current to the patient during the first second or the first seconds of treatment prevents the sensation of pain in the patient.

This device is also programmed so that the pulsed high voltage current (CPAV) is supplied with a voltage peak between 60 and 90 volts since at higher or lower voltages it has a smaller effect presenting said pulsed current a pulse duration between 40 and 60 microseconds and a frequency between 60 and 125 hertz.

It should be mentioned that the amplitude of this high voltage pulsed current must be sufficient to produce a comfortable sensation in the patient without producing a motor response.

Both the direct current and the high voltage pulsed current can be manipulated from the user interface of the device and from the handle having been provided for this purpose that this handle comprises suitable push buttons to control from it the application of direct current and high pulsed current voltage, according to the invention, this device comprises, connected to the microprocessor, a control driver of a vacuum pump suitable for applying a suction in the area of current application to the patient, using in this case a specific needle for vacuum, attachable to a handle that has buttons to control from it the direct current, the pulsed current and the vacuum pressure to apply.

Said handle is provided with a suction sleeve that can be attached to the vacuum pump and an electric cable for application to the needle of the current supplied by the direct current (DC) and high voltage pulsed current (CPAV) generating modules. .

Description of the figures.

To complement the description that is being made and in order to facilitate the understanding of the characteristics of the invention, a set of drawings is attached to the present specification in which, for illustrative and non-limiting purposes, the following has been represented:

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 Figure 1 shows a front elevation view of an embodiment of the device for treatment

Therapy of musculoskeletal lesions provided with an electrode and a needle holder for the application of direct current and high voltage pulsed current to the patient.

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 Figure 2 shows a block diagram of Figure 1.

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 Figures 3a and 3b show respective graphs respectively of the direct current (DC) and of the pulsed high voltage current (CPAV) to be applied to the patient by the device of the previous figures.

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 Figure 4 shows a variant embodiment of the device of Figure 1 additionally including means for the application of a suction in the area of application of the direct current (DC) and the pulsed high voltage current (CPAV)

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 Figure 5 shows a block diagram of the device of Figure 4.

Preferred embodiment of the invention.

In the exemplary embodiment shown in Figures 1 and 2, the device of the invention as a whole referenced as (1a) has an external user interface (2) constituted by buttons for the selection of the currents to be supplied and a screen of visualization (3) of the parameters selected for the treatment, this device (1a) having a positive electrode (4) to establish contact with the patient, for example by means of its manual grip, and a needle holder (5) for coupling and electrical connection to the device of a conductive needle (6) intended to be inserted into the patient to apply the current supplied by the device (1a) in the area to be treated.

This device (1a) comprises, as can be seen in figure 2 a CPU (7) to which the user interface (2) and the display screen (3) referenced in figure 1 are connected, a module

(8) control and load management for the power supply of the device (1a) and a microprocessor (9).

This device (1a) is provided with a module (10) direct current generator and with a module (11) high voltage pulsed current generator responsible for generating respectively the direct current and the high voltage pulsed current to be applied to the patient by positive electrode medium (4) and needle (6).

Said modules (10, 11) are controlled by the microprocessor (9) and are connected to an intensity control module (12) by which the microprocessor (9) determines the intensity, voltage and even the polarity applied to the patient.

The high voltage pulsed current generator module (11) is associated with a pulse generator (13) controlled by the microprocessor (9).

As shown in figure 3 the direct current supplied by the module (10) generating it must be of an intensity between 0.1 and 15 milliamps that is rising progressively in milliamps, (for example: 0, 1 milliampere, 0.2 milliamps, 0.3 milliamps, ...) until reaching a milliampere; Once this value of 1 milliamp is reached, the current goes up from milliampere to milliampere up to a maximum of 15 milliamps, the time goes up to a maximum of 30 seconds (scale from 1 to 30 seconds) per intervention.

The applied voltage appears automatically on the display screen (3) by means of the internal intensity - time calculation, also, the energy consumed in Joules appears automatically on the display by the intensity-voltage-time calculation.

The current and time values of the current to be applied are adjusted using the user interface (2).

As can be seen in Figure 3b, the high voltage pulsed current (CPAV) supplied by the module

(11) The generator has a voltage peak in a range of 60 to 90 volts, this current (CPAV) showing a single phase pulsed waveform.

The pulse duration is between 40 and 100 microseconds and the frequency in a range between 60 to 125 hertz.

Both the control of the direct current and of the pulsed current of high voltage supplied can be manipulated through the user interface (2) and through the handle (5) which has buttons

(51) to apply the direct current and the high voltage pulsed current simultaneously.

In the example of embodiment shown in Figures 4 and 5, the device, referenced as a whole as device (1b) in addition to the functional elements described in the previous embodiment incorporates a vacuum pump controlled by the microprocessor (9) through a control driver (15) said vacuum pump (14) being suitable for applying a suction in the current application zone by means of a needle (6a) specific for vacuum.

In this case, the use of a handle (5a) suitable for needle coupling (6a) and for connection to the vacuum pump (14) by means of a suction sleeve (16) and the device (1b) is contemplated. ) by means of an electric cable (17); so that through the aforementioned needle (6a) a suction can be performed and a continuous current and a pulsed high voltage current simultaneously applied to the patient. In

5 In this case, the handle (5a) has buttons (51) to control from it the direct current, the pulsed current and the vacuum pressure to be applied.

Once the nature of the invention has been sufficiently described, as well as a preferred embodiment, it is stated for the appropriate purposes that the materials, shape, size and arrangement of the described elements may be modified, provided that this does not imply an alteration. of the characteristics

10 of the invention that are claimed below.

Claims (6)

1.-Device for the therapeutic treatment of musculoskeletal injuries; said device comprising: a load management and control module (8) for feeding the device, a module (10) direct current generator (DC) controlled by a microprocessor (9) and suitable to supply a direct current to the patient; a user interface (2) connected to a CPU (7) for the selection of the characteristics and application time of the current to the patient; a display screen (3) of the treatment parameters; a positive electrode (4) and a needle holder (5, 5a) (6, 6a) suitable for applying current to the patient, the external contact of the positive electrode and the insertion of a needle into the area to be treated: characterized in that it comprises a module (11) high voltage pulsed current generator (CPAV) provided with a pulse generator (13), controlled by the microprocessor (9) and suitable for supplying the patient through the positive electrode (4) and the handle ( 5, 5a) needle holder (6, 6a), a high voltage pulsed current (CPVA), in the form of a single phase pulsed wave. 2. Device according to claim 1, characterized in that the module (10) direct current generator (DC) and the module (11) high voltage pulsed current generator (CPAV) are connected to a current control module ( 12) suitable to allow microprocessor control (9) of the current intensity supplied to the patient. 3. Device according to any one of the preceding claims, characterized in that it is provided with specific software for supplying a direct current (DC) of an intensity comprised between 0.1 milliamps and 15 milliamps, progressively rising up to said value of 15 milliamps for a maximum time of 30 seconds; and to supply a pulsed current (CPAV) with a peak voltage between 60 and 90 Volts, with a pulse duration between 40 and 100 microseconds and a frequency between 60 and 125 Hertz (Hz). Device according to any one of the preceding claims, characterized in that the handle (5) comprises push buttons (51) suitable for controlling from it the application of direct current (DC) and high voltage pulsed current (CPAV) . 5. Device according to any one of claims 1 to 3, characterized in that it comprises, connected to the microprocessor (9), a control driver (15) of a vacuum pump (14) suitable for applying a suction in the area of application of current to the patient by means of a needle (6a) specific for vacuum, attachable to a handle (5a) that has: buttons (51) to control the direct current, the pulsed current and the pressure of the vacuum to be applied; a suction sleeve (16) attachable to the vacuum pump (14), and an electric cable (17) for application to the needle (6a) of the current supplied by the modules (10, 11) direct current generators (10, 11) DC) and high voltage pulsed current (CPAV). SPANISH OFFICE OF THE PATENTS AND BRAND Application no .: 201330973 SPAIN Date of submission of the application: 06.28.2013 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: A61N1 / 20 (2006.01) RELEVANT DOCUMENTS

Category

56 Documents cited Claims Affected

X

US 5514165 A (MALAUGH et al.) 07.05.1996, column 3, line 47 - column 4, line 22. 1.2

TO

3

X

US 6064911 A (WINGROVE) 16.05.2000, column 1, line 54 - column 2, line 48. 1.2

TO

3

X

US 2002068961 A1 (FISCHER et al.) 06.06.2002, paragraphs [13-22]. 1.2

TO

3

TO

CN 202136687 U (UNIV. HANGZHOU DIANZI) 08.02.2012, summary. 1-3

TO

CN 202654547 U (WANG GUANPENG) 09.01.2013, summary. 1-3

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the date of priority submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of realization of the report 21.04.2014

Examiner A. Cárdenas Villar Page 1/4

REPORT OF THE STATE OF THE TECHNIQUE Application number: 201330973 Minimum documentation sought (classification system followed by classification symbols) A61N Electronic databases consulted during the search (name of the database and, if possible, terms of search used) INVENES, EPODOC, WPI, NPL, INSPEC, BIOSIS, MEDLINE State of the Art Report Page 2/4  WRITTEN OPINION Application number: 201330973 Date of Completion of Written Opinion: 04/21/2014 Statement

Novelty (Art. 6.1 LP 11/1986)

Claims Claims fifteen IF NOT

Inventive activity (Art. 8.1 LP11 / 1986)

Claims Claims 3 -5 1 -2 IF NOT

The application is considered to comply with the industrial application requirement. This requirement was evaluated during the formal and technical examination phase of the application (Article 31.2 Law 11/1986).  Opinion Base.- This opinion has been made on the basis of the patent application as published. State of the Art Report Page 3/4  WRITTEN OPINION Application number: 201330973  1. Documents considered.- The documents belonging to the state of the art taken into consideration for the realization of this opinion are listed below.

Document

Publication or Identification Number publication date

D01

US 5514165 A (MALAUGH et al.) 07.05.1996

D02

US 6064911 A (WINGROVE) 16.05.2000

D03

US 2002068961 A1 (FISCHER et al.) 06.06.2002

D04

CN 202136687 U (UNIV. HANGZHOU DIANZI) 08.02.2012

D05

CN 202654547 U (WANG GUANPENG) 01.01.2013

 2. Statement motivated according to articles 29.6 and 29.7 of the Regulations for the execution of Law 11/1986, of March 20, on Patents on novelty and inventive activity; quotes and explanations in support of this statement The patent application under study has an independent claim, No. 1, which refers to a device comprising a direct current generator, controlled by a microprocessor, user interface, display, a positive electrode and a conductive needle carrying element , and which is characterized in that it also comprises a high voltage pulsed current generator module that uses the electrode and the needle to deliver a high voltage pulsed current. The device is used for the therapeutic treatment of musculoskeletal injuries. Dependent claims 2-5 refer to other elements and functional characteristics of the device: in No. 2 the existence of a current intensity control module is claimed; in No. 4, push buttons of the needle bearing element to control the current; in No. 5 a control device of a vacuum pump to produce a suction effect by means of a needle; in No. 3 the built-in software is claimed to be able to supply a direct current with a certain intensity and a pulsed current with a voltage, duration and frequency with certain values. As the claims are currently written, we could consider document D01 as the closest in the state of the art. This document describes a device, also applicable in the therapeutic treatment of musculoskeletal injuries, with a DC source that comprises a module for supplying direct current for neuromuscular electrical stimulation and a module for delivering high pulsed current. low intensity voltage The device has a processor that controls both modules and is provided with means (interface) to allow the user direct control of the operation and the intensity of the stimulation or to allow direct programming of the device for a given treatment. It also has a screen that shows a series of parameters related to the mode of operation of the device (see e.g. column 3, line 47 - column 2, line 48). Unlike the application under study, this device does not include a needle carrying element and the corresponding needle for current application, but the application of direct current in electrotherapy devices by means of needle electrodes is well known in the state of the technique for which it has been considered that claim 1, although novel, would be affected by its inventive activity by the content of document D01. It would also affect claim 2 which refers to the control by the processor of the intensity of the current supplied. Documents D02 (see eg column 1, line 54 - column 2, line 48) and D03 (see eg paragraphs 13-22) also describe multifunctional electrotherapy devices that, by controlling a microprocessor, can provide neuromuscular stimulation treatments and treatments using a high voltage pulsed current and it has been considered that they would also affect the inventive activity of claims 1.2 of the application under study. On the other hand, documents D04 and D05 describe different aspects of the state of the art and, in particular, treatment devices by pulsed high-voltage currents (the D04 includes the use of needle electrodes). State of the Art Report Page 4/4