RU207239U1 - Electrode for stimulation and interference electroneuromyography of the pelvic floor muscles and external anal sphincter - Google Patents

Abstract

The useful model relates to medicine, namely to electrodes for electroneuromyography of the pelvic floor muscles and external anal sphincter. The electrode contains a housing and conductive elements made on the housing. The body is flat and flexible and contains a working (1) and connector (2) parts. The working part includes paired proximal (3), paired distal (4) and distal longitudinal (5) fixing ends. The working part is made with the possibility of fixing the researcher's glove on the finger using fragments of double-sided adhesive tape and contains atraumatic rounded edges. The conductive elements include at least two stimulating contacts (6) connected by conductive tracks (7) with corresponding connector contacts (8), and at least two recording contacts (9) connected by conductive tracks (10) with corresponding connector contacts (11 ). EFFECT: avoiding the risk of unwanted displacement of the body of the electroneuromyography electrode relative to the investigator's finger. 1 ill.

Description

The useful model relates to electrodes intended for the diagnostic study of the human neuromuscular system, namely to electrodes for stimulation and interference electroneuromyography (ENMG) of the pelvic floor muscles and external anal sphincter.

Stimulation electroneuromyography is a method for studying the human neuromuscular system, in which the bioelectric potential of a muscle is recorded in response to an electrical stimulating effect on the nerve. Analyzing the response of a muscle, one can judge the presence of defects and disturbances in the work of the neuromuscular system. The studied parameters include latency, duration, amplitude and form of the received muscle response.

Since the pelvic floor muscles are not visually available to the examiner, identification of a particular patient muscle can be accomplished by palpation. Therefore, the most convenient way to place the electrode of the electromyographic (EMG) system on the muscle desired by the doctor is to place the electrode on the muscle of interest directly under the finger. The most accurate way to assess the functional state of the innervation of the muscles under study is stimulation ENMG of the pudendal nerve, which is performed rectally (or vaginally for women) by placing a stimulating electrode attached to the researcher's fingertip in the projection of the tubercle of the sciatic spine, and the recording electrode at the base of the researcher's finger.

One of the devices of the prior art, which solves the problem of placing an electrode on a doctor's finger, is a glove with electrodes attached to it, declared in US Pat. No. 6,567,990 B1, 05/27/2003 (https://patents.google.com/patent/US6567990B1/en? oq = US + 6567990 + B1). The known device is intended exclusively for the implementation of the interference EMG method. On the hand of the researcher in a latex or vinyl glove, two surface electromyographic electrodes are placed on the palmar side - one at the tip of the index finger, the other at the base of the finger at some distance from the first. The recommended electrode spacing is 1 inch (2.54 cm). The electrodes are connected to the EMG signal recording system by means of wires running along the back of the glove. To fix the active and reference electrodes on the surface of the glove, an additional “fingertip” with cutouts is used to expose the sensor surfaces of the electrodes. To register bioelectric activity from the desired muscle, the doctor presses the surface of the active electrode against it with his finger and asks the patient to make an arbitrary contraction. In the known device, the electrodes are not directly fixed to the researcher's finger, but are placed and held by the “fingertip”. It is important to emphasize that in the known device, the electrodes are not located on a separate flexible body. With the known method of placing the electrodes, there is a risk of their displacement relative to the finger, since the glove itself, on which the electrodes are fixed, is not rigidly fixed on the doctor's hand and can be displaced relative to the hand on which it is worn. Importantly, due to electrode displacement, the recorded EMG data may not correspond to the area of interest of the study. Thus, the disadvantages of this device are: the possibility of using it only for interference EMG and the risk of displacement of the electrodes during the study with the claimed method of placing them on the doctor's finger.

The prototype of the claimed utility model is St. Mark's electrode (Electromyography and Pudendal Nerve Terminal Motor Latency // Mellgren AF, Zetterstrom J., Nilsson BY // In: Wexner SD, Duthie GS (eds) Constipation. Springer, London, 2006, http: / /eknygos.lsmuni.lt/springer/600/105-109.pdf, as well as Christiansen J. Delivery and pudendal nerve function // Tetzschner T., Sorensen M., Johnson L., Lose G. // Acta Obstet Gynecol Scand , 1997) for stimulation electroneuromyography of the pelvic floor muscles and external anal sphincter. St. Mark's electrode contains a housing and conductive elements. The body is flat and flexible and contains a working and connector parts. The working part is made with the possibility of one-time fixation on the finger of the researcher's glove using an adhesive layer applied to it. Also, the working part contains a distal longitudinal fixing end and two proximal transverse fixing ends. The conductive elements include two stimulating contacts connected by conductive tracks with corresponding connector contacts, and two recording contacts connected by conductive tracks with corresponding connector contacts.

A disposable St. Mark's electrode is placed on the index finger of the gloved hand of the researcher and inserted into the anal canal or vagina into the projection area of the pudendal nerve in the sciatic spine. A stimulating electrical impulse is applied to the stimulating contacts located in the distal part of the electrode, and the response of the muscles of the anal sphincter and / or pelvic floor is recorded through the recording contacts located in the proximal part of the electrode. The arrangement of the contacts on the glove finger allows the researcher to manipulate the electrode and precisely position the stimulating and recording elements in the areas required for the study.

However, when using the St. Mark electrode in the process of medical research, there is a risk of peeling the case from the glove, which leads to displacement of the contacts relative to the area of interest of the study and the impossibility of positioning the electrode. This phenomenon is not uncommon in clinical practice.

When the contacts are displaced, the recorded data will be incorrect and will not allow assessing the presence and localization of the impulse conduction defect. Accordingly, such displacement is undesirable, and there is a need to provide an electrode that is fixed to the physician's finger in such a way that displacement of the contacts relative to the finger is unlikely.

Thus, there is a need to create an electrode that, during electroneuromyography of the pelvic floor muscles and external anal sphincter, while on the researcher's finger, will not shift relative to its original location on the finger.

The technical result consists in preventing the risk of unwanted displacement of the electrode body relative to the researcher's finger when conducting an electroneuromyographic study of the pelvic floor muscles and the external anal sphincter.

The technical result is achieved in that the electrode for stimulation and interference electroneuromyography of the pelvic floor muscles and external anal sphincter contains a body and conductive elements made on the body, and: the body is made flat and flexible and contains a working and connector parts; the working part includes paired proximal transverse fixing ends, paired distal transverse fixing ends and an unpaired distal longitudinal fixing end; the working part is made with the possibility of fixing on the finger of the researcher's glove using fragments of double-sided adhesive tape and contains atraumatic rounded edges; conductive elements include at least two stimulating contacts connected by conductive tracks with corresponding connector contacts, and at least two recording contacts connected by conductive tracks with corresponding connector contacts.

The proposed electrode allows for stimulation and interference electroneuromyography of the pelvic floor muscles and external anal sphincter. The location of the electrode on the researcher's index finger allows recording in the mode of interference activity: tonic bioelectrical activity (BEA) of the muscles of the external sphincter and pelvic floor, arbitrary BEA, neuro-reflex reactions of the pelvic floor muscles in the form of a cough test and a test with tension of the muscles of the anterior abdominal wall, fatigue sphincter, as well as indirectly assess the state of the puborectal muscle during a straining test. This electrode allows these tests to be carried out in the anal canal directly at 3, 6, 9 and 12 o'clock of an imaginary dial, which makes it possible to pinpoint the presence and localization of a sphincter defect. The inclusion of additional elongated ends in the body allows for better fixation of the electrode on the researcher's finger, preventing its displacement. The rounded edges of the body allow to reduce traumatization of the examined organs.

FIG. 1 shows the proposed electrode. The numbers indicate: 1 - the working part of the electrode body; 2 - connector part of the electrode body: 3 - paired proximal transverse fixing ends; 4 - paired distal transverse fixing ends; 5 - distal longitudinal fixing end; 6 - stimulating contacts; 7 - conductive tracks connecting stimulating contacts and their corresponding connector contacts; 8 - connector contacts corresponding to stimulating contacts; 9 - registering contacts; 10 - conductive tracks connecting the recording contacts and their corresponding connector contacts; 11 - connector contacts corresponding to the registering contacts.

The proposed electrode is a thin flat flexible body (1, 2) made of non-conductive material, on which conductive elements are applied - conductive tracks (7, 10) and contact pads (6, 9, 8, 11) (stimulating, recording and connector pins).

The flexible body has a working part (1) and a connector part (2).

The connector part (2) is designed to accommodate the connector contacts (8, 11) of the conductive elements on it. The indicated connector pins are used to connect the electrode to the connector of external devices. The output of an electric current generator (not shown in Fig. 1), designed to generate a stimulating current, can be connected to the connector contacts (8) connected by conductive tracks (7) with stimulating contacts (6). A device (not shown in Fig. 1) can be connected to the connector contacts (11) connected by conductive tracks (10) with the recording contacts (9), which makes it possible to register the electric potential of the muscle caused by the stimulating effect. Such devices are widely known in the prior art and are used to record the electrical activity of muscles in electromyography systems.

The connector part (2) of the electrode body goes into the working part (1). The working part (1) of the electrode body is designed to be placed on the researcher's finger and inserted into the anal canal or the patient's vagina. The working part (1) of the body includes paired proximal transverse (3), paired distal transverse (4) and single distal longitudinal (5) fixing ends. The distal and proximal transverse fixing ends extend from the central longitudinal part of the body and allow the electrode body to be fixed to the investigator's glove finger by means of fragments of double-sided adhesive tape.

Fragments of double-sided adhesive tape are glued to the electrode body on the side opposite to that on which the open stimulating and recording contacts are located. Fragments of double-sided adhesive tape are glued to the electrode body at the factory.

The flexibility of the paired transverse fixing ends allows them to bend around the researcher's finger, while the fixing ends tightly press the electrode body against the researcher's finger and prevent the body from migrating relative to the finger. In addition, the introduction of additional points of contact between the electrode body and the finger in the form of paired proximal and distal fixing ends will provide an additional contact area between the electrode body and the researcher's finger, which will improve adhesion and reduce the risk of unwanted displacement of the electrode body relative to the researcher's finger during electroneuromyographic examination of the pelvic floor muscles. and the external anal sphincter.

The length of the paired transverse fixing ends of the working part of the body in the proposed utility model should be such that, when bending around the researcher's finger, the fixing ends in the corresponding pairs are overlapped on the back of the finger. When the transverse fixing ends are overlapped on the finger, the electrode body is not simply fixed on the researcher's glove, but pressed directly against the researcher's finger. Thus, the migration of the glove on the researcher's hand does not affect the location of the electrode contacts, since its body is fixed directly relative to the researcher's finger. The length of the distal longitudinal fixing end should be such that when the electrode is fixed on the investigator's finger from the palm side, the specified end can go around the tip of the finger and stick with a piece of double-sided adhesive tape along the nail surface to the back of the finger. Paired proximal and distal transverse fixing ends, bending around the finger, should be glued by means of fragments of double-sided adhesive tape over the glued distal longitudinal fixing end on the back of the finger with an overlap.

On the working part (1) of the body there are recording (9) and stimulating (6) contacts. Stimulating contacts can be made in the distal part of the working part of the housing in the region of the distal transverse fixing ends, and the recording contacts - in the proximal part of the working part of the housing in the region of the proximal fixing ends. These contacts are open on the outer surface of the flexible body to enable their electrical contact with the patient's tissues. The registering (9) and stimulating (6) contacts are connected to the connector contacts (8, I) by conductive tracks (7, 10) running along the body along the working and connector parts of the body.

A thin flat flexible case with conductive elements applied to it, in essence, is a flexible printed circuit board. Techniques for making such printed circuit boards are well known in the art. In particular, for the manufacture of the proposed electrode can be applied technologies used for the manufacture of flexible printed circuit boards intended for use in medicine, and disclosed, for example, in document US 6024702 A. 15.02.2000.

The body of the proposed electrode may have a thin non-conductive flexible base on which a printed circuit is etched (for example, by the etching method described in document US 5493074 A, 20.02.1996). The specified base can be made, for example, of silicone or mylar (polyethylene terephthalate). The printed circuit is made in the form of conductive elements (conductive tracks, stimulating contacts, registering contacts and connector contacts), the material of which can be, for example, steel, platinum, gold or copper. The printed circuit is covered with a protective coating made of non-conductive material. The coating prevents contact between the conductive paths connecting the stimulating and recording contacts with the corresponding connector contacts and the patient's tissue. Stimulating, recording and connector contacts are open on the surface of the case, i.e. in the places of these contacts, there is no protective coating and the contacts protrude on the surface of the case. The protective coating can be made of silicone, for example.

Thus, in the proposed model, the displacement of the electrode body relative to the researcher's finger is prevented.

An example of an electrode application.

Before the procedure, the protective film was removed from the double-sided adhesive tape glued to the electrode, the electrode was placed by the working part of the case on the palmar surface of the operator's straightened index finger with contacts outward. The stimulating contact anode was positioned at the fingertip. The distal longitudinal fixing end was glued along the nail surface of the finger. Next, the distal transverse fixing ends were glued around the finger over the longitudinal fixing end. In the next step, the proximal fixing ends were fixed around the toe with the distal longitudinal fixing end fixed.

In the laboratory of clinical pathophysiology, the conditions for conducting stimulation electroneuromyography were reproduced and comparative tests of various electrode samples were performed. An assessment was made for the convenience of using the product by the operator, comfort for the patient and the duration of the electrode in a given position on the researcher's finger.

By gluing the electrode to the glove with the obligatory mutual intersection of the fixing ends in the proposed sample of the electrode, a stronger connection was created due to additional points of contact and retention of the glued elements of the product to each other, which increased the resistance of the adhesive to mechanical stress in an aggressive environment and prevented the migration of the electrode on the researcher's finger , which is observed when using the traditional St. Mark's electrode.

Technique for performing stimulation EMG.

After applying the electrode contact conductive gel, the researcher inserts the electrode into the anal canal or vagina. In this case, the patient is in a supine position with the legs bent at the hip and knee joints. A saline-moistened grounding electrode is attached to the patient's leg. The anatomical stimulation point is located. Stimuli with a duration of 0.2 ms and a frequency of 0.5 Hz are applied. The pudendal nerve is stimulated at its entrance to the pelvis through the lesser sciatic foramen before it branches into the inferior rectal, perineal and dorsal (clitoral) branches. A series of electrical stimuli is performed with registration of the response and calculation of the latency of the right and left nerves. The latent period of conduction of excitation along the motor fibers of the pudendal nerve is recorded at the supramaximal power of the stimulus (supramaximal power is the power that is 30% higher than the maximum, the maximum power is the power at which the amplitude of the M-response stops growing). Normal latency values for rectal electrode placement are 2.1 + 0.2 ms. With the vaginal location of the electrode -1.55-2.54 ms.

Further, using this electrode, the latency of the M-response of the muscles of the external sphincter and the pelvic floor is studied in intrarectal or intravaginal positions, respectively, as well as late phenomena represented by a mixed return-reflex response (Patent for invention of the Russian Federation, No. 2708052, 03.12.2019) in the form of a deep pudendal reflex with single stimulation and in the F-wave mode. The next step, when exposed to sensitive areas (glans penis or clitoris) with the appropriate special stimulating electrodes, is the registration of the response of the bulbocavernous reflex with the help of recording contacts in the proximal part of the electrode. The latency (delay) from the start of stimulation to the receipt of a response is measured. When studying the bulbocavernous reflex, the location of the electrode is not changed, but only its proximal recording contact surfaces are used.

Thus, according to the latent period of the M-response of the external anal sphincter and / or pelvic floor muscles during stimulation of the pudendal nerve, the safety of the conduction of excitation along the distal pudendal nerve is first assessed. Further, the preservation of afferent and efferent conduction along the entire length of the nerve is studied - the mixed return-reflex response (SVRO) - according to the latency of the recorded responses of late phenomena and the state of its neuro-reflex innervation (BCR), revealing signs of pudendal neuropathy.

Interference EMG technique.

The stimulating function is turned off from the electrodes located on the distal part of the electrode, and they are used as recording electrodes. The recording of the bioelectric activity signal is carried out in the interference EMG program, while the signal is first recorded from the muscles of the external sphincter at rest and during various functional tests, as described above. The bioelectrical activity of the sphincter is assessed using a conventional dial in order to identify its defects. Then the researcher's finger is transferred to the projection of the pelvic floor muscles and their BEA is recorded on the right and left at rest and during straining in order to diagnose signs of spasm of the puborectal loop.

Claims (1)

An electrode for stimulation and interference electroneuromyography of the muscles of the pelvic floor and the external anal sphincter, containing a body and conductive elements made on the body, the body is made flat and flexible and contains a working and connector parts, while the conductive elements include at least two stimulating contacts connected conductive tracks with corresponding connector contacts, and at least two recording contacts connected by conductive tracks with corresponding connector contacts, while the working part of the housing includes paired proximal transverse fixing ends and a distal unpaired longitudinal fixing end, characterized in that the working part of the housing contains atraumatic rounded edges, includes paired distal transverse fixing ends and is configured to be fixed on the researcher's glove finger using fragments of double-sided adhesive tape.

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