JP7483221B2 - Electromyograph probe, external device connector for probe, connection structure between electromyograph probe and external device connector, biofeedback device - Google Patents

Description

The present invention relates to an electromyograph probe that is inserted into the anus and used to measure the strength of the external anal sphincter, a probe external device connector that can electrically connect (link) the probe to an external device, a connection structure between the electromyograph probe and the external device connector, and a biofeedback device that generates perceptible information based on biosignals sensed by the probe.

An electromyograph is a device (measuring instrument) that detects biosignals (electrical signals) generated by the external anal sphincter, measures the strength of the external anal sphincter and changes in the sphincter, and strengthens the muscles and treats and prevents urinary leakage and incontinence while checking the measured biosignals. An electromyograph probe that is inserted into the anus is used to detect the biosignals. Electromyograph probes (hereafter referred to as "probes") are commercially available and come in a variety of shapes (Non-patented technical documents 1-7).

As shown in Figure 15, the main probes in the prior art documents have an insertion part A to be inserted into the anus, and two electrodes C at opposing points on the outer circumferential surface of the axis B of the insertion part A; when the insertion part A is inserted into the anus, the two electrodes C come into contact with the external anal sphincter, enabling the biosignals of the external anal sphincter to be sensed. The biosignals sensed by the two electrodes C are sent to a signal processing part D of the electromyograph, and the potential difference with a reference electrode attached to any point on the surface of the body is measured.

Since the probe is inserted into the anus, it is generally disposable for hygienic reasons, but it is expensive, costing several thousand yen each, and because the lead wire (cable) E extending from the signal processing unit D of the electromyograph is directly attached (fixed) inside the handle F of the probe as shown in Figure 15, making it disposable would be costly. Furthermore, the insertion part A, electrode C, and lead wire E all have the mechanical strength to be repeatedly used, so it would be a waste to make them disposable. For this reason, they are disinfected and sterilized after use and are actually reused. However, this is unhygienic, and people who have them inserted are reluctant to use them.

http://www.medicalexpo.com/en/prod/thought-technology/product-70321-739531.html https://www.biostim.no/produkt/rektal-sensor-u-control-bekkenbunnopptrener/ http://www.medicalexpo.it/prod/beacmed/product-67740-600829.html https://beckenboden-trainer.de/sonden/vaginalsonden/32/vaginalsonde-bei-inkontinenz.-beckenbodenmusculatur https://ja.aliexpress.com/store/product/Super-Slim-Vaginal-or-Anal-Probe-for-EMG-STIM-EMS-Biofeedback-EMG-TENS-PELVIC-FLOOR-EXERCISERS/234181_32414048195.html https://www.advantagemedical.com/products/pathway-rectal-sensor-for-emg-and-e-stim/ https://medicalquip.com/product/rectal-sensor-with-stim/

The present invention provides a probe in which the insertion portion to be inserted into the anus or both the insertion portion and the protruding portion not inserted into the anus can be disposable, an external device connector (coupler) for the probe that can be connected to the probe, a connection structure between an electromyograph probe and an external device coupler, and a biofeedback device.

The probe of the present invention has an insertion part that can be inserted into the anus, and a protruding part (non-insertion part) that protrudes outside the anus even when the insertion part is inserted into the anus. The insertion part and the protruding part are either continuous integrated or detachable separate. Both the insertion part and the protruding part have electrodes. In the case of the integrated type, the electrode of the insertion part and the electrode of the protruding part are continuous, and in the case of the separate type, the electrode of the insertion part and the electrode of the protruding part are electrically connected when the insertion part and the protruding part are attached. In both the integrated and separate types, an external device (e.g., a signal processing part of an electromyograph) is connected to the electrode of the protruding part by a connector. The connected external device receives a biological signal from the inside of the anus detected by the electrode of the insertion part through the electrode of the protruding part. In the case of the separate type, the insertion part can be separated from the protruding part and used for disposal, and in the case of the integrated type, the connector can be removed from the protruding part and the insertion part and the protruding part can be used for disposal as a single unit.

In the case of an integrated type, it is desirable to make both the insertion part and the protruding part out of inexpensive materials so that the economic burden is reduced even if the part is disposable. In the case of a separate type, both the insertion part and the protruding part can be made out of materials suitable for disposable use, but it is also possible to make only the insertion part out of a material suitable for disposable use and the protruding part out of a material strong enough for repeated use. It is desirable to have a structure or mechanism that allows the insertion part and the protruding part to be detached and attached with a simple operation (one-touch operation).

In both the separate and integrated types, the probe can be provided with an isolation sheet. The isolation sheet can be placed against the buttocks when the insertion part is inserted into the anus, and prevents discharge or leakage from the anus from traveling down the insertion part and adhering to the protruding part. The isolation sheet can be, for example, disk-shaped. The isolation sheet can be integrated with the probe or can be separate. If it is separate, it is attached to the probe when in use, and can be disposed of together with the probe or removed from the probe after use.

The packaged probe of the present invention is configured such that the probe is packaged in a package together with an isolation sheet, a portion of the package is opened, the isolation sheet is removed from within the package, and the insertion portion of the probe in the package is inserted into the isolation sheet to attach the isolation sheet to the probe, so that the insertion portion can be inserted into the anus.

The external device connector for a probe of the present invention is a device for electrically connecting an external device (e.g., an electromyograph) to the probe, and can be easily attached to and detached from the protruding portion of the probe.

In the biofeedback device of the present invention, biosignals sensed by the electrodes of the probe are sent to an electromyograph or other external device via a connector, where they are converted into perceptible information, and for example, an image is displayed on a monitor screen, which can be used for biofeedback evaluation and treatment.

The probe of the present invention has the following effects.
1. In the case of the separate type, the insertion part can be separated from the protruding part and can be used for disposable purposes, which is hygienic. The protruding part can be reused, which reduces the economic burden.
2. In the case of the one-piece type, not only the insertion part but also the protruding part can be disposed of, making it hygienic.
3. When an external device is connected to the protruding portion with a connector, the probe can be detached from the connector after use and disposed of, regardless of whether it is an integrated type or a separate type, which is hygienic.
4. When an isolation sheet is attached to the probe, it is possible to prevent leakage from the anus from traveling from the insertion part to the protruding part, thereby preventing the protruding part from becoming dirty and making it hygienic.
5. If isolation sheets are disposable, it will be even more hygienic.

The packaged probe of the present invention has an isolation sheet attached to the insertion part of the probe that protrudes from the opening of the package, and the package can be held in the hand and the insertion part can be inserted into the anus. After use, the insertion part is removed from the anus and stored in the package taken out at the time of insertion, and can be disposed of (disposable). This means that the hands do not need to touch the insertion part before or after insertion, making it hygienic.

The external device connector for a probe of the present invention allows an external device to be attached to and detached from the probe with a simple operation, so that the probe can be removed from the external device after use, making the probe disposable.

The biofeedback device of the present invention generates perceptible information based on the biosignals sensed by the electrodes of the probe, and if that information is converted into an image that can be displayed on a monitor screen, the image can be viewed by the doctor and patient and can be effectively used for biofeedback evaluation and treatment.

FIG. 2A is a perspective view of an example of a probe of the present invention, and FIG. 2B is a perspective view of the probe with an isolation sheet attached to an insertion portion thereof. FIG. 2 is an explanatory diagram showing the state in which the probe of the present invention is inserted into the anus and the isolation sheet is placed against the buttocks. 13A to 13D are explanatory diagrams illustrating a case where an electromyograph is connected to a protruding portion of a probe of the present invention using a connector. FIG. 13 is an explanatory diagram of a case where the connector connected to the probe of the present invention is a clip. FIG. 13 is an explanatory diagram of another example of a probe and a connector of the present invention. FIG. 6 is an explanatory diagram of the attachment of the probe and the connector of FIG. 5 . FIG. 13 is an explanatory diagram showing an example of a connector having a restricting protrusion. 6A is a plan view of the connector of FIG. 5, FIG. 6B is a side view of the connector of FIG. 5 to which a probe is attached, FIG. 6C is a front view of the extension arm of FIG. 5, and FIG. 6D is a plan view of an isolation sheet. FIG. 2A is an explanatory diagram of a packaged probe in which the probe and the isolating sheet of the present invention are packaged in a bag, and FIG. 2B is an explanatory diagram of the state in which the upper half of the bag in FIG. 2A has been opened. 4A is a perspective view of another example of a probe of the present invention, and FIG. 4B is an explanatory diagram of the connection between the insertion portion of FIG. 4A and a connector. 1A is a perspective view showing an example of a probe made up of multiple members, and FIG. 1B is a perspective view of FIG. 1A from a different angle. FIG. 12 is a perspective view showing a state in which the probes in FIGS. FIG. 2 is a block diagram illustrating a signal processing unit of the electromyograph. FIG. 2A is a schematic diagram of a biofeedback device of the present invention, and FIG. 2B is an explanatory diagram of evaluation and treatment using the biofeedback device. FIG.

[Integrated Probe Example 1]
As an example of the present invention, a probe 1 shown in FIG. 1(a) is an integrated type having an insertion portion 2 to be inserted into the anus and a protruding portion 3 that protrudes outside the anus even when the insertion portion 2 is inserted into the anus.

The probe 1 in FIG. 1(a) has a rod-shaped or tubular base 4 with an insertion section 2 at the tip and a protruding section 3 at the rear. The insertion section 2 has a bulging section 5 at the tip, similar to the insertion section of existing probes. The bulging section 5 is tapered to make it easier to insert into the anus, and is thicker than the base 4 to make it difficult to remove from the anus. The length, diameter, shape, etc. of the insertion section 2 can be designed as desired, but may be the same as those of existing probes. The length, diameter, shape, etc. of the protruding section 3 can also be designed as desired, but at least it is long enough to protrude outside the anus even if the insertion section 2 is inserted into the anus. The shaft diameter of the protruding section 3 can be made thicker than the shaft diameter of the insertion section 2 to make it difficult to insert into the anus. The probe 1 in FIG. 1(a) is an integrated type in which both the insertion section 2 and the protruding section 3 are disposable, so both are made of inexpensive materials suitable for disposable use, such as resin, rubber, paper, etc.

[electrode]
The base 4 in FIG. 1(a) has electrodes 6 (hereinafter, one of them is referred to as "electrode 6X" and the other as "electrode 6Y") at two circumferentially opposing locations. The two electrodes 6X and 6Y are conductive metal sheets, metal films, metal thin films, etc., and when the insertion portion 2 is inserted into the anus, they come into contact with the muscle in the anus, for example, the external anal sphincter, and sense the biosignals of the muscle. When the electrodes 6X and 6Y are metal sheets or metal films, they can be fixed to the outer circumferential surface of the base 4. Any fixing method may be used. When they are thin films, they can be attached to the outer circumferential surface of the base 4 and formed into a film by means of spraying, coating, etc. Each of the two electrodes 6X and 6Y is a single piece that is continuous from the insertion portion 2 to the protruding portion 3, and is made to have a length and width that makes it possible to contact the muscle in the anus when inserted into the anus. Of these electrodes 6X and 6Y, electrode 6b (hereinafter, one will be referred to as "electrode 6Xb" and the other as "electrode 6Yb") of protrusion 3 is adapted to be connected to an external device, for example, an external device connector (e.g., a connector, clip, etc.) 8 for connecting to an electromyograph 7. External device connector 8 is electrically connected to a signal processing unit 10 of external device 7 by a lead wire 9 (hereinafter, one will be referred to as "lead wire 9X" and the other as "lead wire 9Y"). Signal processing unit 10 processes biosignals sensed by electrodes 6X and 6Y of insertion portion 2 inserted into the anus.

[Example 1 of a probe external device connector]
Various structures (mechanisms) can be considered for the external device connector (hereinafter referred to as "connector") 8 that connects the protrusion 3 of the probe 1 of the present invention to the signal processing unit 10. As an example, the connector 8 shown in Figures 3(a) to (d) has a male connector (male connector) 11 and a female connector (female connector) 12 that are detachable. The male connector 11 has two male electrodes 13 (hereinafter, one of them will be referred to as the "male electrode 13X" and the other as the "male electrode 13Y"), and the female connector 12 has two insertion holes 14 (hereinafter, one of them will be referred to as the "insertion hole 14X" and the other as the "insertion hole 14Y") into which the male electrodes 13X and 13Y can be inserted. The two male electrodes 13X and 13Y are parallel in the longitudinal direction, and the entrance sides of the two insertion holes 14X and 14Y are parallel, so that the inner ends are close to each other. With this structure, when the two male electrodes 13X, 13Y are inserted into the two insertion holes 14X, 14Y, the male electrodes 13X, 13Y approach each other and are pressed against the electrodes 6Xb, 6Yb of the protrusion 3, enabling electrical continuity between the electrodes 6X (6Xb), 6Y (6Yb) of the probe 1--male electrodes 13X, 13Y--lead wires 9X, 9Y--signal processing unit 10, so that a biosignal sensed by the electrode 6a of the insertion portion 2 (hereinafter, one will be referred to as the "electrode 6Xa" and the other as the "electrode 6Ya") is sent to the signal processing unit 10. In Figure 3, there are protrusions 15 on the inner surface of male coupler 11 and female coupler 12. When male coupler 11 and female coupler 12 abut against the outer periphery of protrusion 3, as in Figure 3 (c), protrusions 15 are inserted into recesses 16 (Figures 3 (b) and (d)) on the outer periphery of protrusion 3, preventing male coupler 11 and female coupler 12 from rotating around the axis of protrusion 3.

[Example 2 of external device connector for probe]
Another example of the connector 8 for connecting the protruding portion 3 of the probe 1 to the signal processing portion 10 is shown in FIG. 4. This connector 8 is a clip. The clip can be opened and closed like a general-purpose clothes peg, and has a clamping electrode 17 (hereinafter, one of them is referred to as the "clamping electrode 17X" and the other as the "clamping electrode 17Y"). The clamping electrodes 17X and 17Y clamp and hold the electrodes 6Xb and 6Yb of the protruding portion 3, and enable electrical continuity between the electrodes 6Xa and 6Ya of the insertion portion 2, the clamping electrodes 17X and 17Y, the lead wires 9X and 9Y, and the signal processing portion 10. When the two operating portions 18X and 18Y are brought close to each other in the direction of the arrow a, the tip side opens in the direction of the arrow b, releasing the clamping.

[Integrated Probe Example 2]
Another example of the probe 1 of the present invention, shown in Figure 5, is also an integrated type in which the insertion portion 2 and the protruding portion 3 are continuous. This probe 1 also has electrodes 6X, 6Y at two opposing positions on the outer circumferential surface of the base 4. Two electrode protrusions 20 (hereinafter, one will be referred to as "electrode protrusion 20X" and the other as "electrode protrusion 20Y") protrude from the upper portions of the electrodes 6X, 6Y. The upper end of the base 4 is divided into two by a split groove 21, and can be opened and closed to the left and right. Below the split groove 21, an upper groove 22 and a lower groove 23 are opened, penetrating the base 4 horizontally. A rotation stop protrusion 24 protrudes from the outer circumferential surface of the base 4.

The connector 8 connected to the probe 1 in FIG. 5 includes a connector body 25 and an extension arm 26, as shown in FIG. 5 and FIG. 6. The connector body 25 is a thick plate with a horizontally elongated elliptical shape, and has a fitting hole 27 penetrating vertically in the horizontal center, and a horizontally elongated fitting recess 28 at the end. The inside (left end) of the fitting recess 28 communicates with the fitting hole 27, and the tip side (right end) opens to the tip of the connector body 25, and a fitting plate 29 is located in the thickness direction center. A slip-out prevention protrusion 30 protrudes upward from the tip of the fitting plate 29. There are two electrode protrusions 31 (hereinafter, one of them is referred to as "electrode protrusion 31X" and the other is referred to as "electrode protrusion 31Y") at positions facing the inner circumferential surface of the fitting hole 27. The electrode protrusions 31X and 31Y are directly attached to the lead wires 9X and 9Y of an external device, and the lead wires 9X and 9Y are drawn out from the rear end of the connector body 25. The inner surface of the fitting hole 27 also has a concave rotation stopper 32 (Figure 6). The rotation stopper 32 may also be convex.

To prevent the probe 1 from being inserted into the fitting hole 27 in the wrong orientation, a restricting protrusion 27a can be provided on the inner circumferential surface of the fitting hole 27 near one opening, as shown in FIG. 7. When the restricting protrusion 27a is provided, the probe 1 can be inserted from one side, but cannot be inserted from the other side. This makes it possible to prevent the probe 1 from being inserted into the fitting hole 27 in the wrong orientation. When the probe 1 is inserted in the correct orientation, its tip hits the restricting protrusion 27a, aligning the upper groove 22 of the probe 1 in the specified position.

The extension arm 26 in Figure 5 has a fitting groove 35 between the upper plate 33 and the lower plate 34, and the left end of the fitting groove 35 is open and has a horizontally elongated U-shape in side view. A push-in protrusion 36 protrudes forward from the tip of the upper plate 33, and a stopper 37 protrudes downward from the tip of the upper plate 33. This extension arm 26 can slide back and forth in the directions of arrows a-b in Figure 6, and when pushed in the direction of arrow a, the fitting groove 35 covers the fitting plate 29 of the fitting recess 28. When the extension arm 26 is pulled in the direction of arrow b as in Figure 6, the stopper 37 engages with the anti-slip protrusion 30, preventing the extension arm 26 from falling out of the fitting recess 28.

[Example 3 of external device connector for probe section]
The protrusion 3 and the connector 8 in Fig. 5 are connected as follows. As shown in Fig. 8(a) and (b), the protrusion 3 of the probe 1 is inserted vertically into the fitting hole 27 of the connector main body 25. At this time, the rotation stopper 32 (Fig. 6) on the inner peripheral surface of the fitting hole 27 is fitted with the rotation stopper protrusion 24 (Fig. 6) on the outer peripheral surface of the base 4 of the probe 1 to prevent the probe 1 from rotating freely. In this state, the extension arm 26 is pushed into the fitting recess 28 of the connector main body 25, and the push-in protrusion 36 of the extension arm 26 is inserted into the upper groove 22 (Fig. 6) on the peripheral surface of the base 4 of the probe 1 as shown in Fig. 8(a). As a result, the upper end of the base 4, which is divided into two parts, is pushed outward to the left and right, and the electrode protrusions 20X and 20Y of the electrodes 6X and 6Y of the probe 1 are pressed against and contact the electrode protrusions 31X and 31Y of the fitting hole 27. 8(b), the lower plate 34 of the extension arm 26 is inserted into the lower groove 23 of the base 4, ensuring contact between the electrode protrusions 20X, 20Y of the electrodes 6X, 6Y of the probe 1 and the electrode protrusions 31X, 31Y of the fitting hole 27. By connecting in this manner, electrical continuity is established among the electrode protrusions 20X, 20Y of the electrodes 6X, 6Y of the probe 1, the electrode protrusions 31X, 31Y of the fitting hole 27, the lead wires 9X, 9Y, and the signal processing unit 10, so that the biosignals sensed by the electrodes 6X, 6Y of the probe 1 are sent to the signal processing unit 10.

[Example of a Separate Probe]
Another example of the probe 1 of the present invention is shown in Figures 10(a) and 10(b). This probe 1 is a separation type in which the insertion part 2 and the protruding part 3 can be separated at any point in the longitudinal direction of the rod-shaped or cylindrical base body 4. The basic shapes of the insertion part 2 and the protruding part 3 are the same as those of the insertion part 2 and the protruding part 3 in Figure 1(a). It is preferable that the detachment structure (detachment mechanism) of the insertion part 2 and the protruding part 3 can be detached from the insertion part 2 by a one-touch operation without touching the insertion part 2. As an example, the one shown in Figure 10(b) has a thin-diameter part 40 at one end in the longitudinal direction of the protruding part 3, and the thin-diameter part 40 can be press-fitted into the inner hole 41 of the insertion part 2. When the insertion part 2 and the protruding part 3 are connected, the electrodes 6Xa and 6Ya of the insertion part 2 and the electrodes 6Xb and 6Yb of the protruding part 3 can be electrically connected to each other.

A connector 8 can be fitted to and removed from the outer periphery of the protruding portion 3 of the probe 1 in Fig. 10(a). The connector 8 in Fig. 10(a) is ring-shaped and can be fitted over the outer periphery of the protruding portion 3. As shown in Fig. 10(b), the connector 8 has a tapered inner hole 42 that narrows downward, and an electrode (connector electrode) 43 is located on the inner surface of the inner hole 42.

[Connection of connector to protrusion]
When the inner hole 42 of the connector 8 in Figures 10(a) and (b) is fitted onto the outer periphery of the protrusion 3, the connector 8 is connected to the protrusion 3, and the connector electrodes 43X, 43Y are electrically connected to the electrodes 6Xb, 6Yb of the protrusion 3, respectively, and electrically connected to the electrodes 6Xa, 6Ya of the insertion portion 2--the electrodes 6Xb, 6Yb of the protrusion 3--the connector electrodes 43X, 43Y--the lead wires 9X, 9Y--the signal processing unit 10. Thus, the biological signals sensed by the electrodes 6Xa, 6Ya of the insertion portion 2 are sent to the signal processing unit 10.

In Figures 10(a) and (b), the connector 8 is connected to the protruding portion 3 of the probe 1 to electrically connect to the external device 7, but if possible, the connector 8 can be omitted and the lead wires 9X and 9Y can be directly attached to the electrodes 6Xb and 6Yb of the protruding portion 3 of the probe 1. In this case, the protruding portion 3 to which the lead wires 9X and 9Y are connected can be reused, and only the insertion portion 2 can be made disposable.

[Another embodiment of the probe]
From the viewpoint of productivity, the integrated probe and the separated probe can be composed of a plurality of members as shown in Figures 11(a) and 11(b). The probe 1 shown in Figures 11(a) and 11(b) includes a main body 45 having a base 4 and a bulge 5, and two mounting fixtures 46 (hereinafter, one of them will be referred to as "mounting fixture 46X" and the other as "mounting fixture 46Y") to be mounted on the main body 45.

Two vertically elongated fitting grooves 45Xa, 45Ya are provided at opposing positions on the outer periphery of the base 4 of the main body 45. Two coupling fitting holes 45c (Fig. 11(b)) are provided at an interval in the longitudinal direction of the base 4 in the intermediate portion 45b between the fitting grooves 45Xa, 45Ya.

Each of the attachments 46X, 46Y has a semi-cylindrical head 46Xa, 46Ya and a shaft-like portion 46Xb, 46Yb protruding downward in the figure from the head 46Xa, 46Ya. A horizontal rectangular recess 46Xc, 46Yc is provided on the surface of the head 46Xa, 46Ya facing the other attachment 46X, 46Y. An upper depression 46Xf, 46Yf is provided on the upper side of each recess 46Xc, 46Yc, and a lower depression 46Xg, 46Yg is provided on the lower side. An electrode placement portion 46Xd, 46Yd is provided vertically on the arc-shaped surface of the head 46Xa, 46Ya.

The shaft-shaped portions 46Xb, 46Yb are rod-shaped portions that fit into the fitting grooves 45Xa, 45Ya of the main body 45, and on the surface facing the other mounting device 46X, 46Y, two connecting portions 46Xe, 46Ye that connect to the other mounting device 46X, 46Y are provided at a distance in the longitudinal direction of the shaft-shaped portions 46Xb, 46Yb. The distance between the two connecting portions 46Xe, 46Ye is the same as the distance between the connecting portion fitting holes 45c of the main body 45.

In the example shown in Figures 11(a) and (b), the two mounting fixtures 46X and 46Y have the same shape. By making them the same shape, both mounting fixtures 46X and 46Y can be manufactured using one molding die, thereby reducing manufacturing costs. In the example shown in Figures 11(a) and (b), the connecting parts 46Xe and 46Ye are located to the right of half the width (short side) of the shaft-shaped parts 46Xb and 46Yb, so that when the two mounting fixtures 46X and 46Y are placed opposite each other, the opposing inner surfaces of the connecting parts 46Xe and 46Ye are connected to each other.

Electrodes 6X, 6Y, which are U-shaped in cross section, are fitted and held on the outside of the shaft-shaped portions 46Xb, 46Yb. The electrodes 6X, 6Y are slid from the lower end side (the end opposite the heads 46Xa, 46Ya) of the shaft-shaped portions 46Xb, 46Yb to cover the outside of the shaft-shaped portions 46Xb, 46Yb. The electrodes 6X, 6Y are exposed to the outside when the attachments 46X, 46Y are attached to the main body portion 45.

The main body 45 and the two mounting fixtures 46X, 46Y are integrated as shown in Fig. 12 by fitting the shaft-shaped parts 46Xb, 46Yb of the mounting fixtures 46X, 46Y into the respective fitting grooves 45Xa, 45Ya of the main body 45, and the coupling parts 46Xe, 46Ye provided on both shaft-shaped parts 46Xb, 46Yb are coupled to each other through the coupling part fitting holes 45c. At this time, an upper groove 22 is formed at the position where the recessed parts 46Xc, 46Yc of the coupled mounting fixtures 46X, 46Y face each other, an upper fitting groove 22a is formed at the position where the upper recessed parts 46Xf, 46Yf face each other, and a lower fitting groove 22b is formed at the position where the lower recessed parts 46Xg, 46Yg face each other. The upper groove 22 is the portion into which the push-in protrusion 36 of the extension arm 26 fits, and the upper fitting groove 22a and the lower fitting groove 22b are the portions into which the rotation stopper 32 (see FIG. 5) fits when the rotation stopper 32 is made convex. The convex rotation stopper 32 fits into the upper fitting groove 22a and the lower fitting groove 22b to prevent the probe 1 from spinning freely.

11(a) and (b) show an example in which the electrodes 6X and 6Y are U-shaped in cross section, but the electrodes 6X and 6Y can also be formed by attaching a conductive film such as metal foil to the outside of the shaft-shaped parts 46Xb and 46Yb. Also, in the example of FIG. 11(a) and (b), the mounting devices 46X and 46Y are connected to each other to fix the two mounting devices 46X and 46Y to the main body part 45, but the two mounting devices 46X and 46Y can also be fixed to the main body part 45 individually. Also, in the example of FIG. 11(a) and (b), the main body part 45 is made of one member, and the mounting devices 46X and 46Y are made of two members, but the main body part 45 can be made of two or more members, and the mounting device 46 can be made of one or three or more members.

[Isolation sheet]
The base 4 of the probe 1 of the present invention can be fitted with an isolation sheet 50 as shown in Fig. 1(b), Fig. 5, Fig. 6, Fig. 8(b), Fig. 9(a)(b), and Fig. 10(a). As an example, the isolation sheet 50 shown in Fig. 5 is disc-shaped, and the base 4 can be inserted into a hole 51 provided in the center. The isolation sheet 50 may be in a shape other than a disc. It is preferable to fix the isolation sheet 50 to the base 4 by any means, for example, an adhesive tape or a pressure sensitive adhesive, so that the isolation sheet 50 does not shift in the axial direction of the base 4 or fall off the base 4. The isolation sheet 50 is a sheet that is attached to the outside of the periphery of the base 4 to isolate the connector main body 25 and the insertion part 2. As shown in Fig. 2, when the insertion part 2 is inserted into the anus, the isolation sheet 50 can be applied to the outer buttocks of the anus, and can receive bodily fluids (leakage) discharged or leaked from the anus and flowing down the insertion part 2, preventing adhesion to the protruding part 3. The isolation sheet 50 is preferably made of a soft material that can be easily fitted to the buttocks.

The isolation sheet 50 is separate from the probe 1 and is removable from the base 4 of the probe 1, but if possible, it can also be integrated with the base 4. The isolation sheet 50 is also made of a disposable, inexpensive material, and it is preferable that it is waterproof.

[Packaged Probe]
The probe 1 and the isolating sheet 50 can be packaged in a packaging container, for example, a packaging bag 52, as shown in Fig. 9(a)(b). The packaging bag 52 in Fig. 9(a)(b) is made of a material that can be opened by hand or with scissors. To use the probe 1 and the isolating sheet 50, the upper part of the packaging bag 52 is cut to remove the isolating sheet 50 as shown in Fig. 9(b), and the probe 1 still in the packaging bag 52 is pushed into the hole 51 of the isolating sheet 50 to attach the isolating sheet 50 to the probe 1. Next, the connector 8 (Fig. 5) is set on the protruding part 3 of the probe 1 still in the packaging bag 52 as shown in Fig. 8(b). In this case, the isolating sheet 50 and the connector 8 can be attached without touching the insertion part 2 of the probe 1. After use, the connector 8 is removed from the protruding part 3 of the probe 1, the probe 1 removed from the anus is returned to the packaging bag 52 with the insertion part 2 facing down, and the insertion part 2 is disposed of together with the packaging bag 52 (disposable). The packaging container may be something other than a packaging bag, but is preferably made of a material suitable for disposable use, such as paper or resin film.

[Signal Processing Section]
In both the integrated and separate types, the biosignals sensed by the electrodes 6Xa, 6Ya of the insertion section 2 are weak and difficult to process by an electromyograph as is. The biosignals can be extracted by amplifying the biosignals in the signal processing section 10 and removing unnecessary signals (mainly noise). The signal processing section 10 measures the potential difference between the extracted biosignals and another location on the body surface, for example, a reference electrode O (FIG. 13) attached to the abdominal surface.

An example of an external device 7 connected to the probe 1 of the present invention is an electromyograph. An example of a signal processing unit 10 of an electromyograph is shown in FIG. 13. The signal processing unit 10 in FIG. 13 is the same as the signal processing unit of a general-purpose electromyograph. It is equipped with high-pass filters (F1, F2) connected to the two electrodes 6X, 6Y of the probe 1, amplifiers (AMP1, AMP2) that amplify the signals from the respective filters (F1, F2), a differential amplifier (AMP3) that takes the difference between the signals from both amplifiers and amplifies it, a notch filter (F3) that does not pass signals of a specific frequency from the differential amplifier but passes signals of other frequencies, a low-pass filter (F4) that passes low-frequency signals from the notch filter (F3), and an analog/digital converter (ADC).

As shown in FIG. 14(a), the biofeedback device of the present invention has the electrodes of the probe 1 and a reference electrode (electromyograph electrode) O attached to an arbitrary location on the body surface connected to a signal processing unit 10, which is in turn connected to a monitor 60. An image based on the biosignal processed by the signal processing unit 10 is displayed on the monitor 60. The same image signal is transmitted wirelessly or via cable to a large auxiliary monitor 61 to display the image, which can be used for biofeedback evaluation and treatment while the doctor and patient check (watch) it, as shown in FIG. 14(b).

The above embodiment is an example of the present invention, and is not limited thereto. In particular, the detachable structure of the insertion section 2 and the protruding section 3 in the case of a separate probe, the structure (mechanism) and shape of the connector 8 connecting the protruding section 3 of the probe 1 to the signal processing section 10, and the connecting structure of the protruding section 3 and the connector 8 can be configured differently (mechanisms) within the scope of the invention that can achieve the object of the present invention. In addition, the probe 1 shown in the figure can also be used to sense biological signals other than those of the external anal sphincter. In addition to sensing biological signals, it can also be used to electrically stimulate various muscles in the anus. In this case, a device capable of generating a stimulation signal is used as the external device.

REFERENCE SIGNS LIST 1 Probe 2 Insertion section 3 Protrusion section 4 Base body 5 Bulging section 6, 6X, 6Y Electrodes 6a, 6Xa, 6Ya (insertion section) electrodes 6b, 6Xb, 6Yb (protrusion section) electrodes 7 External device (electromyograph)
DESCRIPTION OF SYMBOLS 8 Connector 9, 9X, 9Y Lead wire 10 Signal processing unit 11 Male connector 12 Female connector 13, 13X, 13Y Male electrode 14, 14X, 14Y Insertion hole 15 Protrusion 16 Recess 17, 17X, 17Y Clamped electrode 18, 18X, 18Y Operation unit 20, 20X, 20Y Electrode protrusion 21 Split groove 22 Upper groove 22a Upper fitting groove 22b Lower fitting groove 23 Lower groove 24 Rotation stop protrusion 25 Connector body 26 Extension arm (push-in tool)
27 Fitting hole 27a Restricting protrusion 28 Fitting recess 29 Fitting plate 30 Fall-off prevention protrusion 31, 31X, 31Y Electrode protrusion (connector electrode)
32 Rotation stopper 33 Upper plate 34 Lower plate 35 Fitting groove 36 Push-in protrusion 37 Stopper 40 Thin-diameter portion 41 Inner hole (of insertion portion) 42 Inner hole (of connector) 43X, 43Y Electrode (connector electrode)
45 Main body 45Xa, 45Ya Fitting groove 45b Middle portion 45c Joint fitting hole 46, 46X, 46Y Wearing device 46Xa, 46Ya Head 46Xb, 46Yb Shaft-shaped portion 46Xc, 46Yc Recessed portion 46Xd, 46Yd Electrode placement portion 46Xe, 46Ye Joint portion 46Xf, 46Yf Upper recessed portion 46Xg, 46Yg Lower recessed portion 50 Separating sheet 51 Hole (in separating sheet) 52 Packaging bag 60 Monitor 61 Auxiliary monitor A Insertion portion B Shaft C Electrode D Signal processing portion E Lead wire (cable)
F Handle O Reference electrode ADC Analog/digital converter AMP1, AMP2 Amplifier AMP3 Differential amplifier F1, F2 High-pass filter F3 Notch filter F4 Low-pass filter

Claims (10)

In electromyography probes,
An insertion part (2) to be inserted into a sensing site capable of sensing a biological signal from a sphincter in the body;
The insertion portion (2) is provided with a protruding portion (3) that protrudes outside the body when the insertion portion (2) is inserted into the sensing site,
The insertion portion (2) and the protruding portion (3) are integrally formed into a continuous rod-like or cylindrical shape,
Electrodes (6Xa, 6Ya) are provided directly on the outer circumferential surface of the insertion portion (2), and electrodes (6Xb, 6Yb) are provided directly on the outer circumferential surface of the protrusion portion (3),
The electrodes (6Xa, 6Ya) of the insertion portion (2) and the electrodes (6Xb, 6Yb) of the protrusion portion (3) are electrically connected to each other,
The electrodes (6Xa, 6Ya) of the insertion portion (2) are sensing electrodes capable of sensing biological signals from a sphincter in the body, and are exposed on the outer circumferential surface of the insertion portion (2) so that the biological signals from the sphincter in the body can be sensed when the insertion portion (2) is inserted into the sensing site,
The electrodes (6Xb, 6Yb) on the protrusion (3) side are external device mounting parts to which an external device connector (8) that is connected to an external device (7) can be attached and detached, and are exposed on the outer circumferential surface of the protrusion (3) so as to be electrically conductive to the connector electrodes (31) of the external device connector (8) when the external device connector (8) is attached.
Electromyograph probe characterized in that: In electromyography probes,
An insertion part (2) to be inserted into a sensing site capable of sensing a biological signal from a sphincter in the body;
The insertion portion (2) is provided with a protruding portion (3) that protrudes outside the body when the insertion portion (2) is inserted into the sensing site,
The insertion portion (2) and the protruding portion (3) are rod-shaped or tubular, and are detachable from each other;
Electrodes (6Xa, 6Ya) are provided directly on the outer circumferential surface of the insertion portion (2), and electrodes (6Xb, 6Yb) are provided directly on the outer circumferential surface of the protrusion portion (3),
the electrodes (6Xa, 6Ya) of the insertion portion (2) and the electrodes (6Xb, 6Yb) of the protrusion portion (3) are electrically connected when the insertion portion (2) and the protrusion portion (3) are connected to each other,
The electrodes (6Xa, 6Ya) of the insertion portion (2) are sensing electrodes capable of sensing biological signals from a sphincter in the body, and are exposed on the outer circumferential surface of the insertion portion (2) so that the biological signals from the sphincter in the body can be sensed when the insertion portion (2) is inserted into the sensing site,
The electrodes (6Xb, 6Yb) on the protrusion (3) side are external device mounting parts to which an external device connector (8) that is connected to an external device (7) can be attached and detached, and are exposed on the outer circumferential surface of the protrusion (3) so as to be electrically conductive with the connector electrodes (43X, 43Y) of the external device connector (8) when the external device connector (8) is attached.
Electromyograph probe characterized in that: 2. The electromyograph probe according to claim 1,
Both the insertion part (2) and the protruding part (3) are made of disposable materials;
Electromyograph probe characterized in that: 3. The electromyograph probe according to claim 2,
The insertion part (2) is made of a disposable material.
Electromyograph probe characterized in that: The electromyograph probe according to any one of claims 1 to 4,
The isolation sheet (50) can be detachably attached to the outer periphery on the protruding portion (3) side relative to the insertion portion (2),
The isolation sheet (50) is capable of receiving bodily fluids that flow along the insertion part (2) inserted into a part of the body capable of sensing biological signals from the sphincter to the protruding part (3) side, and preventing the bodily fluids from adhering to the protruding part (3).
Electromyograph probe characterized in that: 6. The electromyograph probe according to claim 5,
The isolation sheet (50) is made of a disposable material;
Electromyograph probe characterized in that: An external device connector (8) electrically connects an electromyography probe (1) to an external device (7) that electrically processes a biosignal from a sphincter in the body and that is sensed by the electromyography probe (1),
The electromyograph probe is an electromyograph probe according to claim 1 , claim 3, claim 5 or claim 6,
The external device connector (8) includes a connector body (25) that can be directly attached to and detached from the outside of the electrode of the protruding portion of the electromyograph probe (1), a pusher (26) that can be detached from the connector body (25), and a lead wire (9) that is connected to an external device (7);
The connector body (25) has a fitting hole (27) into which the protruding portion (3) of the electromyograph probe (1) can be inserted, and a fitting recess (28) into which the pushing tool (26) can be fitted,
The fitting recess (28) can fit the pushing tool (26) so as to be reciprocally slidable therein,
A connector electrode (31) is provided inside the fitting hole (27), and when the protrusion (3) of the electromyograph probe (1) is inserted into the fitting hole (27) of the connector body (25), the connector electrode (31) can be in conductive contact with the electrodes (6Xb, 6Yb) of the protrusion (3) of the electromyograph probe (1);
When the pusher (26) is slid toward the fitting hole (27) while being fitted into the fitting recess (28), a conductive contact is ensured between the connector electrode (31) in the fitting hole (27) and the electrodes (6Xb, 6Yb) of the protrusion (3) of the electromyograph probe (1).
13. A probe external device connector comprising: A connection structure for an electromyograph probe (1) and an external device connector (8) that electrically connects the probe to an external device (7),
The electromyograph probe (1) is an electromyograph probe according to claim 1 , claim 3, claim 5 or claim 6 ,
The external device connector (8) is an external device connector for a probe according to claim 7,
The protrusion (3) of the electromyograph probe (1) is detachably fitted into the fitting hole (27) of the connector body (25) of the external device connector (8), and when fitted, the connector electrode (31) in the fitting hole (27) and the electrodes (6Xb, 6Yb) of the protrusion (3) are in conductive contact with each other, and when a push-in tool (26) fitted into the fitting recess (28) of the connector body (25) so as to be reciprocally slidable is slid toward the fitting hole (27), conductive contact is ensured between the electrodes (6Xb, 6Yb) of the protrusion (3) and the connector electrode (31) in the fitting hole (27).
A connection structure between an electromyograph probe and an external device connector. 1. A biofeedback device comprising:
An electromyograph probe according to any one of claims 1 to 6;
an external device connector (8) electrically connected to the electrodes ( 6X , 6Y ) of the protruding portion (3) of the electromyograph probe (1);
An external device (7) electrically connected to the external device connector (8),
The external device (7) includes a signal processing unit (D) that generates perceptible information based on a biosignal from a sphincter in the body sensed by the electrodes (6Xa, 6Ya) of the insertion portion (2) of the electromyography probe (1).
A biofeedback device comprising: 10. The biofeedback device of claim 9,
The signal processing unit (D) includes amplifiers (AMP1, AMP2) for amplifying biosignals from the sphincter muscles in the body sensed by the electrodes ( 6X , 6Y ) of the protruding portion (3) of the electromyography probe (1), and filters (F1, F2, F3, F4) for removing unnecessary signals from the biosignals.
A biofeedback device comprising:

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