Patent Description:
An electromyograph is a device (measurement device) that detects a biosignal (body signal) resulting from a muscle activity of, for example, an external anal sphincter or pelvic floor muscles to measure a muscle strength, a change in muscle strength, or the like (perform muscle strength measurement) of the external anal sphincter or the pelvic floor muscles so as to strengthen the muscle or treat and prevent urine leakage or incontinence while checking the measured biosignal. An electromyograph probe, which is inserted into a measurement site (hereinafter referred to as "body organ") such as an anus or a vagina, is used to detect a biosignal. Electromyograph probes (hereinafter referred to as "probes") are commercially available, and have various shapes (Non Patent Literatures <NUM> to <NUM>).

A representative one of probes described in Non Patent Literatures <NUM> to <NUM> mainly includes, as illustrated in <FIG>, an insertion portion A to be inserted into a body organ, and two electrodes C. The electrodes C are provided on an outer peripheral surface of a shaft B of the insertion portion A so as to be opposed to each other. When the insertion portion A is inserted into a body organ in such a manner that the entire shaft B is fully placed inside the body organ, both the electrodes C are brought into contact with, for example, the external anal sphincter or the pelvic floor muscles to detect a biosignal from the muscles described above. The biosignal detected by the two electrodes C is transmitted to a signal processing unit D of an electromyograph, and a potential difference from reference electrodes attached at suitable positions on a surface of the body is measured.

The probe is inserted into a body organ. Thus, from a hygienic viewpoint, the probe is generally discarded after each use. However, when each probe is discarded after single use, cost increases for the following reasons. Each probe is as expensive as several thousand Japanese yen. In addition, as illustrated in <FIG>, a lead wire (cable) E led out from the signal processing unit D of the electromyograph is directly attached (fixed) inside a handle F of the probe. Further, each of the insertion portion A, the electrodes C, and the lead wire E has a mechanical strength that allows repeated use. Thus, it is regrettable to discard the above-mentioned components after single use. Under current conditions, the probe is disinfected or sterilized after each use for subsequent use. However, such use of the probe may lead to hygienic problems, and users may be reluctant to use the probe in the above-mentioned manner. An electromyographic probe with external-device connector according to the state of the art is for instance also described in PL <NUM>.

Aspects of the present invention provide an integrated electromyography probe, a packaged probe, an external-device coupler and a biofeedback device, as set out in the appended set of claims. An object of the present invention is to provide a probe that is easy to use and hygienic, a packaged probe that is usable hygienically, an external-device coupler that enables easy coupling of an external device to the probe, and a biofeedback device that perceptualizes a biosignal detected by the probe.

According to the present invention, there is provided a probe as set out by appended claim <NUM>.

According to the present invention, there is provided a packaged probe as set out by appended claim <NUM>.

According to the present invention, there is provided an external-device coupler as set out by appended claim <NUM>.

According to the present invention, there is provided a biofeedback device as set out by appended claim <NUM>.

The probe according to the present invention has the following effects.

When a part of the package of the packaged probe according to the present invention is cut away to open the package, the insertion portion or the projecting portion is exposed to an outside of the package. The insertion portion or the projecting portion, which remains in the package, is held with a hand together with the package, and thus can be inserted into and removed from a body organ without being directly touched by a hand. Thus, the packaged probe is hygienic.

The external-device coupler according to the present invention enables easy mounting of the external device to the device mounting area of the probe. Thus, the biosignal detected by the probe can be reliably transmitted to the external device.

The biofeedback device according to the present invention enables the biosignal detected by the sensing electrodes of the probe to be checked in the form of the perceivable information. Thus, the biofeedback device can be effectively used for biofeedback evaluations and treatments.

The first and third embodiments of the Integrated probe and External-device coupler are not covered by the subject matter of the claims.

As an example, a probe <NUM> is illustrated in <FIG>. The probe <NUM> is an integrated probe including an insertion portion <NUM> and a projecting portion <NUM> that are continuous with each other. The insertion portion <NUM> is located on a front end side of one base <NUM> having a rod-like or cylindrical shape, and the projecting portion <NUM> is located on a rear end side thereof. A device mounting area Z (<FIG> and <FIG>) is defined on a rear end side of the projecting portion <NUM>.

The insertion portion <NUM> includes an expanded portion <NUM> provided on the front end side of the base <NUM> and part of the base <NUM>, which is located on a side closer to a root of the expanded portion <NUM>. The insertion portion <NUM> is to be inserted into a body organ. The expanded portion <NUM> is tapered for easy insertion into a body organ, and is also formed thicker than the projecting portion <NUM> for prevention of unintended removal from the body organ. A length, a diameter, a shape, and other dimensions of the insertion portion <NUM> may be suitably designed. The above-mentioned dimensions and shape may be the same as or different from those of existing anal or vaginal probes.

The insertion portion <NUM> can be inserted into a body organ. The projecting portion <NUM> is designed so that the device mounting area Z is exposed to an outside of a body after the insertion portion <NUM> is inserted into a body organ (<FIG>). A length, a diameter, a shape, and other dimensions of the projecting portion <NUM> may be suitably designed. The above-mentioned dimensions and shape may be the same as or different from those of existing anal or vaginal probes.

Sensing electrodes <NUM> (<FIG>) are provided on an outer peripheral surface of the insertion portion <NUM>. Two sensing electrodes <NUM> (6X and 6Y) are provided on an outer peripheral surface of the projecting portion <NUM> so as to be opposed to each other. The two sensing electrodes 6X and 6Y are each, for example, an electroconductive thin metal plate, metal film, or thin metal film. When the insertion portion <NUM> is inserted into a body organ, the sensing electrodes 6X and 6Y are brought into contact with a muscle (hereinafter referred to as "body-organ muscle") such as an external anal sphincter or pelvic floor muscles of the body organ to detect a biosignal. When the sensing electrodes 6X and 6Y are thin metal plates or metal films, the sensing electrodes 6X and 6Y can be fixed onto an outer peripheral surface of the base <NUM>. A suitable method may be used as fixing means. When thin films are used as the sensing electrodes 6X and 6Y, the thin films may be formed on the outer peripheral surface of the base <NUM> by means such as adhesion, spraying, or coating. A length and a width of each of the two sensing electrodes 6X and 6Y are set to allow the insertion portion <NUM> to be brought into contact with a body-organ muscle when the insertion portion <NUM> is inserted into a body organ. In <FIG> and <FIG>, the sensing electrodes 6X and 6Y extend from the insertion portion <NUM> to the device mounting area Z (<FIG> and <FIG>) of the projecting portion <NUM>. When an external-device coupler <NUM> (<FIG>) is mounted onto the device mounting area Z (<FIG> and <FIG>), electrodes (coupling electrodes; not shown) of the external-device coupler <NUM> are brought into contact with sensing electrodes 6Xb and 6Yb so as to be electrically conductive therewith.

The external-device coupler (hereinafter simply referred to as "coupler") <NUM> is electrically connected to a signal processing unit <NUM> of an external device <NUM> via a lead wire <NUM> (<FIG>). In this embodiment, the external device <NUM> is an electromyograph. However, the electromyograph is merely an example. In the present invention, any other devices that are capable of generating perceivable information (perceivable signal) to be used for biofeedback based on the biosignal detected by the sensing electrodes may be used as the external device <NUM>.

Various structures and mechanisms are conceivable for the coupler <NUM>. As an example, the coupler <NUM> illustrated in <FIG> includes a male coupler member <NUM> and a female coupler member <NUM>, which can removably mate to each other. The male coupler member <NUM> includes male electrodes <NUM> (13X and 13Y). The female coupler member <NUM> has two insertion holes <NUM> (14X and 14Y) into which the male electrodes 13X and 13Y are insertable. The two male electrodes 13X and 13Y are parallel in a longitudinal direction. The two insertion holes 14X and 14Y are formed so as to be parallel on an inlet side and become closer to each other in a depth direction. With this structure, when the two male electrodes 13X and 13Y are inserted into the two insertion holes 14X and 14Y, the male electrodes 13X and 13Y are brought closer to each other and brought into pressure-contact with the sensing electrodes 6Xb and 6Yb of the probe <NUM>. As a result, the sensing electrodes 6X and 6Y become conductive with the male electrodes 13X and 13Y of the coupler <NUM> and the signal processing unit <NUM> via the lead wire <NUM>, allowing the biosignal detected by the sensing electrodes 6X and 6Y to be transmitted to the signal processing unit <NUM>. Protrusions <NUM> are formed on inner surfaces of the male coupler member <NUM> and the female coupler member <NUM> illustrated in <FIG>, respectively. When the male coupler member <NUM> and the female coupler member <NUM> are brought into abutment against the outer peripheral surface of the projecting portion <NUM> as illustrated in <FIG>, the protrusions <NUM> are inserted into recessed portions <NUM> (<FIG>) formed on the outer peripheral surface of the projecting portion <NUM> to thereby prevent rotation of the male coupler member <NUM> and the female coupler member <NUM> about an axis of the projecting portion <NUM>. The signal processing unit <NUM> is configured to process the biosignal detected by the sensing electrodes 6X and 6Y on the insertion portion <NUM>.

Another example of the coupler <NUM> is illustrated in <FIG>. The coupler <NUM> is a clip. The clip can be opened and closed like a general-purpose clothespin. The coupler <NUM> includes clamping electrodes <NUM> (17X and 17Y) provided on inner surfaces at distal ends of the coupler <NUM>, and operating portions 18X and 18Y on a rear side. In <FIG>, illustration is given of a state in which the two clamping electrodes 17X and 17Y are closed to clamp and hold the sensing electrodes 6Xb and 6Yb of the probe <NUM>. When the two operating portions 18X and 18Y are moved closer to each other in directions indicated by arrows "a", the distal ends are opened in directions indicated by arrows "b" to release the clamping. When the probe <NUM> is clamped and held, the sensing electrodes 6X and 6Y become electrically conductive with the clamping electrodes 17X and 17Y and the signal processing unit <NUM> via the lead wire <NUM>. When the clamping is released, the conduction is interrupted.

An example of the probe <NUM> according to the present invention is illustrated in <FIG>. The probe is an integrated probe including the insertion portion <NUM> and the projecting portion <NUM> that are continuous with each other. The probe <NUM> also includes the two sensing electrodes 6X and 6Y that are arranged on the projecting portion <NUM> so as to be opposed to each other. Two electrode protrusions <NUM> (20X and 20Y) are formed in a protruding manner on upper parts of the sensing electrodes 6X and 6Y, respectively. One electrode protrusion 20X is illustrated in <FIG>. However, another electrode protrusion 20Y is located on a back side of the electrode protrusion 20X, and thus is not illustrated in <FIG>. An end of the base <NUM> is divided into two parts by a division groove <NUM>, and the two parts can be horizontally opened and closed. An upper groove <NUM> having a longitudinally elongated shape and a lower groove <NUM> having a horizontally elongated shape are formed below the division groove <NUM> to pass through the base <NUM> in a width direction. Rotation stopping protrusions <NUM> are formed in a protruding manner on the outer peripheral surface of the base <NUM> so as to be adjacent to the upper groove <NUM>.

The coupler <NUM> illustrated in <FIG>, which is to be coupled to the probe <NUM>, includes a coupler main body <NUM> and an extension arm member <NUM> as illustrated in <FIG> and <FIG>. The coupler main body <NUM> has an ellipsoidal plate-like shape with a large thickness, and has a fitting hole <NUM> and a fitting recessed portion <NUM>. The fitting hole <NUM> is formed in a center of the coupler main body <NUM> in a horizontal direction to vertically pass through the coupler main body <NUM>. The fitting recessed portion <NUM> having a horizontally elongated shape is formed on a distal end side of the coupler main body <NUM>. The fitting recessed portion <NUM> has an inner side (left side) communicating with the fitting hole <NUM> and has an open distal end (right end) on an outer peripheral surface of a distal end of the coupler main body <NUM>. The coupler main body <NUM> has a fitting plate <NUM> in a center in a thickness direction of the coupler main body <NUM>. A retaining protrusion <NUM> is formed at a distal end of the fitting plate <NUM> so as to protrude upward. Two electrode protrusions <NUM> (31X and 31Y) are formed on an inner peripheral surface of the fitting hole <NUM> so as to be opposed to each other. The lead wire <NUM> of the external device is directly connected to the electrode protrusions 31X and 31Y. The lead wire <NUM> is led out from a rear end of the coupler main body <NUM>. A rotation stopper portion <NUM> (<FIG> and <FIG>) having a recessed shape is also formed in the inner peripheral surface of the fitting hole <NUM>. The rotation stopper portion <NUM> may have a protruding shape.

In order to prevent upside-down insertion of the probe <NUM> into the fitting hole <NUM>, a regulating protrusion 27a may be formed on the inner peripheral surface of the fitting hole <NUM> so as to be closer to one opening of the fitting hole <NUM> as illustrated in <FIG>. When the regulating protrusion 27a is formed, the probe <NUM> can be inserted from a front side or a back side (any one of the sides) of the fitting hole <NUM>. However, the probe <NUM> cannot be inserted from another one of the sides. This structure prevents insertion of the probe <NUM> into the fitting hole <NUM> with an inappropriate orientation. When the probe <NUM> is inserted with a correct orientation, a distal end of the probe <NUM> abuts against the regulating protrusion 27a to thereby position the upper groove <NUM> of the probe <NUM> at a predetermined position.

The extension arm member <NUM> illustrated in <FIG> includes an upper plate <NUM>, a lower plate <NUM>, and a fitting groove <NUM> defined between the upper plate <NUM> and the lower plate <NUM>. The fitting groove <NUM> has an open left end, and has a horizontally elongated U-like shape in side view. A push-in protrusion <NUM> protrudes forward from a distal end of the upper plate <NUM>. A stopper <NUM> protrudes downward from the distal end of the upper plate <NUM>. The extension arm member <NUM> can reciprocally slide in directions indicated by arrows "a" and "b" in <FIG>. When the extension arm member <NUM> is pushed in the direction indicated by the arrow "a", the fitting groove <NUM> is fitted over the fitting plate <NUM> of the fitting recessed portion <NUM>. When the extension arm member <NUM> is pulled in the direction indicated by the arrow "b" as illustrated in <FIG>, the stopper <NUM> is caught by the retaining protrusion <NUM> to retain the extension arm member <NUM> in the fitting recessed portion <NUM>.

The extension arm member <NUM> illustrated in <FIG> and <FIG> is inserted and placed in the coupler main body <NUM> as illustrated in <FIG>, and can reciprocally slide in directions indicated by arrows X and Y. In <FIG>, the extension arm member <NUM> is slid in the direction indicated by the arrow X and is pulled out from the coupler main body <NUM> to expose the fitting hole <NUM>. In <FIG>, after a separation sheet <NUM> is placed and the probe <NUM> is inserted into the fitting hole <NUM>, the extension arm member <NUM> is pushed into the direction indicated by the arrow Y to fix the probe <NUM> in the fitting hole <NUM>. Under this fixed state, the sensing electrodes 6X and 6Y of the probe <NUM> are held in contact with the electrode protrusions 31X and 31Y of the coupler <NUM> to achieve a conductive state.

The probe <NUM> is inserted into the fitting hole <NUM> of the coupler <NUM> as illustrated in <FIG>. The projecting portion <NUM> of the probe <NUM> is inserted vertically into the fitting hole <NUM> of the coupler main body <NUM>. At this time, the rotation stopping protrusion <NUM> (<FIG>) formed on the outer peripheral surface of the base <NUM> of the probe <NUM> is fitted into the rotation stopper portion <NUM> (<FIG> and <FIG>) formed in the inner peripheral surface of the fitting hole <NUM> to thereby prevent spinning of the probe <NUM>. Under this state, the extension arm member <NUM> is pushed into the fitting recessed portion <NUM> of the coupler main body <NUM> to insert the push-in protrusion <NUM> of the extension arm member <NUM> into the upper groove <NUM> (<FIG>) formed in a peripheral surface of the base <NUM> of the probe <NUM> as illustrated in <FIG>. As a result, two separate upper ends of the base <NUM> are forced apart from each other in the horizontal direction to push the electrode protrusions 20X and 20Y formed on the sensing electrodes 6X and 6Y of the probe <NUM> against the electrode protrusions 31X and 31Y formed inside the fitting hole <NUM> to achieve contact therebetween. At this time, as illustrated in <FIG>, the lower plate <NUM> of the extension arm member <NUM> is inserted into the lower groove <NUM> of the base <NUM> to ensure the contact between the electrode protrusions 20X and 20Y formed on the sensing electrodes 6X and 6Y and the electrode protrusions (coupling electrodes) 31X and 31Y formed inside the fitting hole <NUM> of the coupler <NUM>. This coupling enables the electrode protrusions 20X and 20Y formed on the sensing electrodes 6X and 6Y to become conductive with the coupling electrodes 31X and 31Y formed inside the fitting hole <NUM> and the signal processing unit <NUM> via the lead wire <NUM>. As a result, the biosignal detected by the sensing electrodes 6X and 6Y is transmitted to the signal processing unit <NUM>.

Another example of a probe <NUM> is illustrated in <FIG>. The probe <NUM> is a disassemblable probe in which the insertion portion <NUM> and the projecting portion <NUM> can be separated from each other at a suitable position on the base <NUM> having a rod-like or cylindrical shape in a longitudinal direction of the probe <NUM>. Basic shapes of the insertion portion <NUM> and the projecting portion <NUM> are the same as those illustrated in <FIG>. It is preferred that the insertion portion <NUM> and the projecting portion <NUM> have a coupling and decoupling structure (coupling and decoupling mechanism) that enables the projecting portion <NUM> to be separated from the insertion portion <NUM> by a single operation without the insertion portion <NUM> being touched by a hand. As an example, the probe <NUM> illustrated in <FIG> includes a small-diameter portion <NUM> at one longitudinal end of the projecting portion <NUM>. The small-diameter portion <NUM> can be press-fitted into an internal hole <NUM> of the insertion portion <NUM> to achieve coupling. When the insertion portion <NUM> and the projecting portion <NUM> are coupled to each other, sensing electrodes 6Xa and 6Ya on the insertion portion <NUM> and the sensing electrodes 6Xb and 6Yb on the projecting portion <NUM> become conductive with each other.

The coupler <NUM> can be fitted over and removed from an outer periphery of the projecting portion <NUM> of the probe <NUM> of <FIG>. The coupler <NUM> of <FIG> has a ring shape that enables fitting over the outer periphery of the projecting portion <NUM>. As illustrated in <FIG>, the coupler <NUM> has an internal hole <NUM> that is tapered downward, and electrodes (coupler electrodes) 43X and 43Y that are formed on an inner surface of the internal hole <NUM> so as to be opposed to each other.

The probe <NUM> is disposable regardless of whether the probe <NUM> is an integrated probe or a disassemblable probe. In this case, an inexpensive material suitable for single use, for example, a resin, a rubber, or paper, is used as a material.

When the internal hole <NUM> of the coupler <NUM> of <FIG> is fitted over an outer periphery of the device mounting area Z of the probe <NUM>, the coupler <NUM> is coupled to the projecting portion <NUM> to make the coupler electrodes 43X and 43Y conductive with the sensing electrodes 6X and 6Y of the probe <NUM>. Thus, the sensing electrodes 6X and 6Y become conductive with the coupler electrodes 43X and 43Y and the signal processing unit <NUM> via the lead wire <NUM>. As a result, the biosignal detected by the sensing electrodes 6X and 6Y is transmitted to the signal processing unit <NUM>.

In <FIG>, the sensing electrodes 6X and 6Y of the probe <NUM> are electrically connected to the external device <NUM> by coupling the coupler <NUM> onto the device mounting area Z of the probe <NUM>. However, the coupler <NUM> may be omitted in some cases. In such a case, the lead wire <NUM> is directly connected to the sensing electrodes 6X and 6Y of the probe <NUM>, and a distal end of the lead wire <NUM> is connected to the external device <NUM>. In this case, the projecting portion <NUM> to which the lead wire <NUM> is connected may be repeatedly used, and only the insertion portion <NUM> may be discarded after single use.

The integrated probe and the disassemblable probe can each be formed of a plurality of members as illustrated in <FIG> in terms of productivity. The probe <NUM> illustrated in <FIG> includes a main body portion <NUM> and two mounted members <NUM> (mounted members 46X and 46Y). The main body portion <NUM> includes the base <NUM> and the expanded portion <NUM>. The mounted members <NUM> are mounted onto the main body portion <NUM>.

Two fitting grooves 45Xa and 45Ya, each being longitudinally elongated, are formed in an outer periphery of the base <NUM> of the main body portion <NUM> so as to be opposed to each other. Two coupling-portion fitting holes 45c (<FIG>) are formed in an intermediate portion 45b between the fitting grooves 45Xa and 45Ya so as to be spaced apart from each other in a longitudinal direction of the base <NUM>.

The mounted members 46X and 46Y include head portions 46Xa and 46Ya and shaft-shaped portions 46Xb and 46Yb, respectively. The head portions 46Xa and 46Ya each have a semicylindrical shape. The shaft-shaped portions 46Xb and 46Yb are formed to protrude downward from the head portions 46Xa and 46Yz in <FIG>, respectively. Recessed portions 46Xc and 46Yc, each having a horizontally elongated rectangular shape, are formed on surfaces of the head portions 46Xa and 46Ya, which are opposed to the counterparts of the mounted members 46X and 46Y, respectively. Upper recessed portions 46Xf and 46Yf are formed above the recessed portions 46Xc and 46Yc, and lower recessed portions 46Xg and 46Yg are formed below the recessed portions 46Xc and 46Yc, respectively. Electrode placement portions 46Xd and 46Yd, each extending longitudinally, are formed on arc-shaped surfaces of the head portions 46Xa and 46Ya, respectively.

The shaft-shaped portions 46Xb and 46Yb are rod-shaped portions to be fitted into the fitting grooves 45Xa and 45Ya of the main body portion <NUM>, respectively. The shaft-shaped portions 46Xb and 46Yb include coupling portions 46Xe and 46Ye to be coupled to counterparts of the mounted members 46X and 46Y. The coupling portions 46Xe and 46Ye are formed on surfaces of the shaft-shaped portions 46Xb and 46Yb, which are opposed to the counterparts thereof. Two coupling portions 46Xe and two coupling portions 46Ye are formed on the shaft-shaped portions 46Xb and 46Yb in a protruding manner so as to be spaced apart from each other in a longitudinal direction of the shaft-shaped portions 46Xb and 46Yb, respectively. Each of a distance between the two coupling portions 46Xe and a distance between two coupling portions 46Ye is set to be the same as a distance between coupling-portion fitting holes 45c of the main body portion <NUM>.

In the example illustrated in <FIG>, the two mounted members 46X and 46Y have the same shape. The same shape of the two mounted members 46X and 46Y allows manufacturing of the mounted members 46X and 46Y with use of a single molding die. Thus, manufacturing cost can be reduced. In the example illustrated in <FIG>, the coupling portions 46Xe and 46Ye are formed at positions on the right side with respect to a center of the shaft-shaped portions 46Xb and 46Yb in a width direction (lateral direction), respectively. These positions allow connection of opposed inner surfaces of the coupling portions 46Xe and 46Ye when the two mounted members 46X and 46Y are placed to be opposed to each other.

The sensing electrodes 6X and 6Y, each having a U-like shape in sectional view, are fitted over and held onto outer sides of the shaft-shaped portions 46Xb and 46Yb. The sensing electrodes 6X and 6Y are slid from lower ends (ends opposite to the head portions 46Xa and 46Ya) of the shaft-shaped portions 46Xb and 46Yb to cover the outer sides of the shaft-shaped portions 46Xb and 46Yb. When the mounted members 46X and 46Y are mounted onto the main body portion <NUM>, the sensing electrodes 6X and 6Y are exposed to an outside.

The main body portion <NUM> and the two mounted members 46X and 46Y are integrated as illustrated in <FIG> in the following manner. The shaft-shaped portions 46Xb and 46Yb of the mounted members 46X and 46Y are fitted into the fitting grooves 45Xa and 45Ya of the main body portion <NUM> to couple the coupling portions 46Xe and 46Ye formed on the shaft-shaped portions 46Xb and 46Yb together in the coupling-portion fitting holes 45c. The upper groove <NUM> is defined at a position at which the recessed portions 46Xc and 46Yc of the mounted members 46X and 46Y that are coupled together are opposed to each other. An upper fitting groove 22a is defined at a position at which the upper recessed portions 46Xf and 46Yf are opposed to each other, and a lower fitting groove 22b is defined at a position at which the lower recessed portions 46Xg and 46Yg are opposed to each other. The push-in protrusion <NUM> of the extension arm member <NUM> is fitted into the upper groove <NUM>. When the rotation stopper portion <NUM> (see <FIG>) is formed in a protruding shape, the rotation stopper portion <NUM> is fitted into the upper fitting groove 22a or the lower fitting groove 22b. The fitting of the rotation stopper portion <NUM> having a protruding portion into the upper fitting groove 22a or the lower fitting groove 22b prevents spinning of the probe <NUM>.

In the example illustrated in <FIG>, the sensing electrodes 6X and 6Y, each having a U-like shape in sectional view, are illustrated as an example. For example, the sensing electrodes 6X and 6Y may be formed by attaching electroconductive films, for example, metallic foils onto outer sides of the shaft-shaped portions 46Xb and 46Yb. Further, in the example of <FIG>, the mounted members 46X and 46Y are coupled together to fix the mounted members 46X and 46Y onto the main body portion <NUM> as an example. However, the mounted members 46X and 46Y may be individually fixed onto the main body portion <NUM>. Further, in the example illustrated in <FIG>, the main body portion <NUM> is formed of one member, and the mounted members 46X and 46Y are formed of two members as an example. However, the main body portion <NUM> may be formed of two or more members, and each of the mounted members <NUM> may be formed of one member or formed of three or more members.

The separation sheet <NUM> can be mounted onto the base <NUM> of the probe <NUM> according to the present invention as illustrated in <FIG>. The separation sheet <NUM> illustrated as an example has a disc-like shape, and has a hole <NUM> formed in a center. The base <NUM> of the probe <NUM> can be inserted into the hole <NUM>. The separation sheet <NUM> may have a shape other than the disc-like shape. It is preferred that the separation sheet <NUM> be made of an elastic material to allow close contact with the base <NUM> that has been inserted or be fixed to the base <NUM> by suitable means, for example, with an adhesive tape or an adhesive so as to prevent positional misalignment in an axial direction of the base <NUM> or unintended removal from the base <NUM>. The separation sheet <NUM> is mounted on an outer side of a periphery of the base <NUM> of the probe <NUM> to separate a part of the probe <NUM>, which is closer to the insertion portion <NUM>, and a part of the probe <NUM>, which is closer to the coupler <NUM>, from each other. When the insertion portion <NUM> is inserted into a body organ as illustrated in <FIG>, the separation sheet <NUM> can be placed so as to be in contact with buttocks. The separation sheet <NUM> receives a body fluid (leakage) that leaks from the body organ and flows down the insertion portion <NUM> to thereby prevent contact of the body fluid with the projecting portion <NUM> of the probe <NUM>.

The separation sheet <NUM> is formed separately from the probe <NUM>, and is mountable to and removable from the base <NUM> of the probe <NUM>. The separation sheet <NUM> may be mounted in advance onto the base <NUM>, and may be integrated with the base <NUM> by another means in some cases. It is preferred that the separation sheet <NUM> be made of an inexpensive disposable material and have water proofness. The separation sheet <NUM> may also be made of a soft material that can easily be placed so as to be in contact with buttocks or an elastic material that enables easy mounting around the projecting portion <NUM>. The separation sheet <NUM>, which is made of an elastic material, allows easy insertion of the probe <NUM> into the hole <NUM> and prevents unintended removal of the probe <NUM> from the hole <NUM> after the insertion of the probe <NUM>.

The probe <NUM> and the separation sheet <NUM> described above can be stored in a package, for example, a packaging bag <NUM> as illustrated in <FIG>. The packaging bag <NUM> illustrated in <FIG> is made of a material that allows the packaging bag <NUM> to be opened with, for example, hands or scissors, and is made of, for example, a resin or paper. When the probe <NUM> and the separation sheet <NUM>, which are packaged, are used, an upper part of the packaging bag <NUM> is cut away as illustrated in <FIG> to allow the separation sheet <NUM> to be taken out of the packaging bag <NUM>. Then, the projecting portion <NUM> of the probe <NUM> that is kept in the packaging bag <NUM> is directly pushed into the hole <NUM> of the separation sheet <NUM> to mount the separation sheet <NUM> around the probe <NUM>. Next, the coupler <NUM> (<FIG>) is mounted onto the device mounting area Z of the probe <NUM> that is kept (remains) in the packaging bag <NUM> as illustrated in <FIG>. In this case, the separation sheet <NUM> and the coupler <NUM> can be mounted without allowing the insertion portion <NUM> of the probe <NUM> to be touched by a hand. After use, the coupler <NUM> is removed from the projecting portion <NUM> of the probe <NUM>. The probe <NUM>, which has been removed from the body organ, is placed into the packaging bag <NUM> again with the insertion portion <NUM> side facing downward. The insertion portion <NUM> is discarded (after single use) together with the packaging bag <NUM>. The package may be other than a packaging bag, and may be a container made of a thin flexible resin or paper. However, it is preferred that the package be made of a material suitable for single use, for example, paper or a resin film, and have a space-saving shape. The probe <NUM> alone may be packaged.

The packaging bag <NUM> may be formed to allow the insertion portion <NUM> side of the probe <NUM> to be exposed to the outside. In this case, the projecting portion <NUM> may be held together with the packaging bag <NUM> with a hand to allow the insertion portion <NUM> to be inserted into a body organ. In this case, the insertion portion <NUM> can be inserted into a body organ without being touched by a hand, and thus is hygienic.

The biosignal detected by the sensing electrodes 6X and 6Y is weak regardless of whether the probe <NUM> is an integrated probe or a disassemblable probe. Thus, it is difficult to directly process the biosignal with an electromyograph. After the biosignal is amplified and an unnecessary signal (mainly, noise) is removed therefrom in the signal processing unit <NUM>, the biosignal is extracted. The signal processing unit <NUM> measures a potential difference between the thus extracted biosignal and reference electrodes O (<FIG>) attached onto a different portion of a body surface, for example, a surface of an abdomen.

An example of the external device <NUM> to be connected to the probe <NUM> according to the present invention is an electromyograph. An example of the signal processing unit <NUM> of the electromyograph is illustrated in <FIG>. The signal processing unit <NUM> illustrated in <FIG> is the same as a signal processing unit of a general-purpose electromyograph. The signal processing unit includes high-pass filters F1 and F2, amplifiers AMP1 and AMP2, a differential amplifier AMP3, a notch filter F3, a low-pass filter F4, and an analog-digital converter ADC. The high-pass filters F1 and F2 are connected to the two sensing electrodes 6X and 6Y of the probe <NUM>, respectively. The amplifiers AMP1 and AMP2 are configured to amplify signals from the high-pass filters F1 and F2, respectively. The notch filter F3 is configured to block passage of a signal at a specific frequency among signals from the differential amplifier and allow passage of a signal at other frequencies. The low-pass filter F4 is configured to allow passage of a low-frequency signal among signals from the notch filter F3.

A biofeedback device according to the present invention includes a monitor <NUM>. As illustrated in <FIG>, the sensing electrodes <NUM> of the probe <NUM> and the reference electrodes (electromyograph electrodes) O attached at suitable positions on a body surface are connected to the signal processing unit <NUM>. The signal processing unit <NUM> is connected to the monitor <NUM>. An image generated based on the biosignal that has been processed in the signal processing unit <NUM> is displayed on the monitor <NUM>. The same image signal as the image signal is transmitted wirelessly or in a wired manner to a large auxiliary monitor <NUM> to display an image thereon. The image can be checked (viewed) by a doctor G and a patient H as illustrated in <FIG> to be used for biofeedback evaluations and treatments. The signal processing unit <NUM> can also generate perceivable information other than image information, for example, audio information based on the biosignal. The perceivable information described above can be stored in a storage device.

Claim 1:
An integrated electromyography probe (<NUM>) configured to be inserted into a body organ to obtain a biosignal, said probe comprising:
an insertion portion (<NUM>) insertable into a body organ;
a projecting portion (<NUM>) that is exposed to an outside of a body after the insertion portion is inserted into the body organ, wherein an end of the projecting portion is divided into two parts by a division groove (<NUM>) and wherein the projecting portion comprises:
in a peripheral surface thereof, a first groove (<NUM>) configured to receive a push-in protrusion (<NUM>) of an extension arm member (<NUM>) of an external-device coupler (<NUM>) and configured so that, upon insertion of said push-in protrusion (<NUM>) into the first groove, said two parts of the projecting portion are caused to force apart from each other; and
a second groove (<NUM>) configured to receive a plate (<NUM>) of the extension arm member (<NUM>) of the external-device coupler, when the push-in protrusion of the external-device coupler is inserted into the first groove;
sensing electrodes (6X, 6Y) configured to detect a biosignal when the insertion portion is inserted into the body organ and having electrode protrusions (20X, 20Y) formed thereon; and
a device mounting area (Z) onto which the external-device coupler is removably mounted,
wherein the sensing electrodes (6X, 6Y) are provided at least on an outer peripheral surface of the insertion portion, and
wherein the electrode protrusions of the sensing electrodes are configured to contact coupling electrode protrusions (31X, 31Y) formed on an inside of a fitting hole (<NUM>) of the external device coupler in order that the sensing electrodes can become conductive with the coupling electrode protrusions of the external-device coupler, when the probe (<NUM>) is inserted into the fitting hole of the external-device coupler and the push-in protrusion (<NUM>) is inserted into the first groove.