Sensor inserting device and operating method thereof

The sensor inserting device includes a device body, a movement mechanism which inserts a detector and an insertion needle into a body of a patient by moving a sensor with the insertion needle, and a dwelling member which is arranged on a moving path of the sensor and attached to the sensor by movement of the sensor caused by the movement mechanism. The dwelling member is allowed to dwell on the skin of the patient with the sensor and the transmitter connected at a location in which the detector is inserted into the body of the patient.

TECHNICAL FIELD

The present invention generally relates to a sensor inserting device for inserting a detector of a sensor which measures biological information of a person to be measured into a body of the person to be measured, and an operating method of the device.

BACKGROUND DISCUSSION

Conventionally, a sensor is inserted or implanted in a body of a patient (person to be measured) to detect an analyte (e.g., glucose or pH, cholesterol, protein, or the like) in blood or body fluid of the patient. In such case, a sensor inserting device is used to penetrate the skin of the patient and to arrange the sensor rapidly and easily (e.g., see JP 2008-506468 Y).

An applicator (sensor inserting device) disclosed in JP 2008-506468 Y includes a needle (insertion needle) which is inserted together with a sensor, a plunger subassembly (movement mechanism) which moves the sensor and the insertion needle for piercing, and an attaching unit (dwelling member) which allows the sensor to dwell on the skin of a patient. Further, an electrode unit (signal processor) having a transmitting function which allows transmitting of obtained information of detected blood sugar level (biological information) to an external medical device is attached to the sensor.

Further, such type of sensor inserting device is used for insertion and dwelling of the sensor in the body of the patient, generally, by steps (an operating procedure) listed below.

1. Attaching a sensor to a sensor inserting device.

2. Releasing a safety mechanism of an insertion needle to allow the insertion needle to move freely.

3. Positioning a dwelling member of the sensor inserting device on a desired location (location of insertion) in a body of a patient, and sticking the dwelling member on to the skin of the patient.

4. Operating the sensor inserting device to insert a detector and the insertion needle in the body of the patient.

5. Separating the sensor inserting device from the patient so that the insertion needle is removed from the sensor, thereby allowing the sensor and the dwelling member to dwell in the body (and on the skin) of the patient.

6. Connecting a signal processor to a sensor portion exposed on the skin of the patient so as to allow the signal processor and the sensor to dwell.

SUMMARY

In an operating procedure of the conventional sensor inserting device, after executing the steps [1] to [5], a user (e.g., a patient) manually connects the sensor and the signal processor in the step [6]. However, when executing the step [6], the sensor dwells on the skin of the patient so that the sufficient stationary state of the sensor is not provided. Further, in the case when the sensor and the signal processor are small sized, it happens that, for example, a precise operation is required for making connection, and this makes the operation of connecting the sensor and the signal processor troublesome, which gives pain to the patient. Particularly, in a case the user is a patient, and when the patient wants to insert, by himself or herself, a sensor in the abdomen (e.g., a flank), one of the arms, or the like, it may be difficult to visually detect the portion to be connected, or the patient may be required to make connection with one hand. Because of such reasons, workability of the operation is deteriorated.

Disclosed here is a sensor inserting device which allows to connect the sensor which is inserted and allowed to dwell on the skin of a person to be measured to a signal processor by a relatively simple operation, thereby enabling shortening of the time of operation so that suffering and pain of the person to be measured can be reduced, and an operating method of the sensor inserting device.

To achieve the object mentioned above, the present invention provides a sensor inserting device which inserts a detector of a sensor for measuring a biological information of a person to be measured in a body of the person to be measured including a device body and a movement mechanism, provided in the device body, which moves the sensor together with an insertion needle which pierces the body of the person to be measured so as to insert the detector and the insertion needle into the body of the person to be measured. The device body is attached with a signal processor which processes a signal including biological information from the sensor. The signal processor is connected to the sensor at a location of insertion, at which the detector is inserted into the body of the person to be measured, and allowed to dwell on the skin of the person to be measured.

According to the configuration mentioned above, the detector of the sensor is inserted into the body of the person to be measured by the movement mechanism. And by connecting the sensor and the signal processor at the location of insertion, the sensor and the signal processor can easily dwell on the skin of the person to be measured. Thereby, the manual operation of connecting the sensor and the signal processor dwelling on the skin of the person to be measured is not necessary. This shortens the operating time of insertion and dwelling of the sensor, and reduces suffering and pain of the person to be measured.

A dwelling member which is arranged on the moving path of the sensor and attached to the sensor by the movement of the sensor caused by the movement mechanism may further be included.

As described above, the sensor inserting device allows the dwelling member to be attached to the sensor by the movement of the sensor caused by the movement mechanism so as the sensor to be supported by the dwelling member without requiring any additional operation. Therefore, the operation of insertion and dwelling of the sensor can further efficiently be carried out.

In this case, the movement mechanism can be configured to movably support the sensor and the insertion needle relative to the device body. The sensor inserting device can be configured to change the state in a manner that: the state changes from the first state in which the sensor and the insertion needle are supported at a location spaced, by a predetermined distance, from a distal end portion of the device body to; a second state in which the dwelling member supports the sensor at the location of insertion, by the sensor and the insertion needle moving toward the distal end direction, with the signal processor attached to the device body, to insert the detector into the body of the person to be measured; after changing to the second state, the state changes to a third state in which the insertion needle is separated from the sensor by the insertion needle moving toward the proximal end direction; and after changing to the third state, the state changes to a fourth state in which the signal processor is connected to the sensor staying at the location of insertion.

As described above, by the changing of the state of the sensor inserting device from the first state to the fourth state, the sensor and the signal processor can easily be connected and allowed to dwell on the skin of the person to be measured. Further, the movement mechanism may include a movable unit which supports the sensor and the insertion needle, an advance spring which gives thrust to the movable unit to move toward the distal end direction of the device body, and a return spring, arranged in a location opposing to the advance spring with the movable unit in between, which moves the insertion needle toward the proximal end direction of the device body.

As described above, by the movable unit supporting the sensor and the insertion needle, and the movable unit moving toward the distal end direction by the advance spring, the state can easily be changed from the first state to the second state (the state in which the detector and the insertion needle are inserted into the body of the person to be measured). Further by the movable unit moving toward the proximal end by the return spring, the state can easily be changed from the second state to the third state (the state in which the insertion needle is separated from the sensor).

Further, the movement mechanism may preferably include a safety mechanism which retains the sensor and the insertion needle in the first state.

By including the safety mechanism for retaining the first state as described above, the sensor inserting device can surely prevent the trouble of piercing the insertion needle by carelessly moving the sensor and the insertion needle toward the distal end direction.

The dwelling member can include an engaging unit which supports the sensor at the location of insertion, a base which supports the state in which the supported sensor is connected to the signal processor, and an adhesive portion which sticks the base on to the skin of the person to be measured.

In this manner, the sensor is supported by the engaging unit and the sensor is supported in a state connected to the signal processor so that the connection between the sensor and the signal processor on the skin of the patient can further firmly be retained, thereby allowing stable and continuous detection of biological information by the sensor.

Further, on the distal end portion of the device body, the dwelling member may be arranged, and also, a signal processor displacement mechanism which allows the signal processor to slide toward the base so as to be supported by the dwelling member after the detector is inserted into the body of the person to be measured may be provided.

By the signal processor displacement mechanism allowing the signal processor to slide toward the base so as to be supported by the dwelling member as in such manner, for example, even when the signal processor is arranged in a manner to move in the direction different from that of the movement of the sensor, the sensor and the signal processor can easily be connected at the location of insertion.

In this case, a push handle which can be displaced by two stages toward the distal end direction of the device body may be provided. It may be configured that the push handle operates the movement mechanism by a first stage displacement to insert the detector and the insertion needle into the body of the person to be measured, and after the first stage displacement, the push handle operates the signal processor displacement mechanism by a second displacement to slide the signal processor.

As described above, by operating the push handle which can be displaced by two stages toward the distal end direction of the device body, the detector and the insertion needle are inserted and the signal processor is made to slide (that is, the signal processor is supported by the dwelling member) so that the sensor and the signal processor are easily connected and allowed to dwell.

Further, the engaging unit is an engaging plate which stands upright against the sensor and engages with the sensor when the sensor comes to the location of insertion. And after engaging with the sensor, the engaging plate may preferably be made to fall down by making contact with the signal processor, by the sliding of the signal processor, thereby making electrical connection between the sensor and the signal processor.

In this manner, the sensor and the signal processor can be connected further firmly and allowed to dwell, thereby allowing the signal processor to surely process biological information detected by the sensor.

Further, the device body includes a guiding member which guides the movement of the sensor. The guiding member may be configured to support the engaging plate in the upright position when the sensor moves, and to cancel supporting of the engaging plate in the upright position when the sensor is engaged. In this manner, the sensor and the engaging plate are firmly engaged with the engaging plate kept in the upright position, thereby supporting the sensor in the dwelling member.

Further, to achieve the object, the present invention has a feature of including first to fourth steps as described below. In the first step, the sensor which measures biological information and the insertion needle are supported at the location spaced, by a predetermined distance, from the distal end portion of the device body of the sensor inserting device, and a signal processor which processes a signal including biological information output from the sensor is attached to the device body. In the second step, after the first step, the movement mechanism provided in the device body moves the sensor and the insertion needle toward the distal end direction to allow the detector of the sensor and a portion of the insertion needle to protrude from the distal end portion of the device body. In the third step, after the second step, the insertion needle is separated from the sensor by moving the insertion needle toward the proximal end direction. In the fourth step, after the third step, the device body is operated to connect the sensor to the signal processor. In this manner, the sensor and the signal processor can be connected by a simple operation of the device.

According to the present invention, the sensor which is inserted to dwell on the skin of the person to be measured and the signal processor can be connected by a simple operation of the device so that the operating time can be shortened, thereby reducing the suffering and pain of the person to be measured.

DETAILED DESCRIPTION

An embodiment of a sensor inserting device and an operating method of the device, representing examples of the device and method disclosed here, will be described in detail below referring to the accompanying drawings.

The sensor inserting device10disclosed here is a device, as illustrated inFIG. 1, for carrying out a predetermined operation at a suitable location on a skin S of a patient (person to be measured), for example, an unobtrusive portion where the body motion is small, such as an abdomen, so as to insert a detector14(seeFIG. 3) of a sensor12into the body of the patient, connect a connecting portion of the sensor exposed on the skin S to a transmitter (signal processor)16, and allow the sensor12and the transmitter16to dwell on the skin S.

Note that, in the description below, based on the illustration of the sensor inserting device10inFIG. 1, the front-and-rear direction of the device is referred to as the X direction, the right-and-left width direction of the device is referred to as the Y direction, and the height direction of the device is referred to as the Z direction (up-and-down direction). Further, the downward direction of the sensor inserting device10is also referred to as the distal end direction or Z1direction and the upward direction of the sensor inserting device10is also referred to as the proximal end direction or Z2direction. Further, the forward direction and the rearward direction of the sensor inserting device10are also referred to as the X1direction and the X2direction, respectively, and the rightward direction and the leftward direction of the sensor inserting device10are also referred to as the Y1direction and the Y2direction, respectively. These directions are used for convenience of description, and therefore, it goes without saying that the sensor inserting device10can be used in any direction.

As illustrated inFIG. 1toFIG. 4, the sensor inserting device10includes a device body18, a movement mechanism20which inserts the detector14of the sensor12into the body of a patient, a push handle22for operating the movement mechanism20, and a dwelling member24which dwells, with the sensor12, on the skin S of the patient (note that, inFIG. 2A to 2CandFIG. 4, illustrations of the transmitter16and the dwelling member24are omitted for ease of understanding of the drawings).

The device body18includes a housing26extending in the up-and-down direction (Z direction) and a slider mechanism (signal processor displacement mechanism)28attached to the distal end portion (lower portion) of the housing26.

As illustrated inFIG. 3, the movement mechanism20includes a head (movable unit)30which is contained inside the housing26and movable in the Z direction, an insertion needle32attached to the distal end portion of the head30, an advance spring34which presses the head30toward the distal end direction (Z1direction), and a return spring36which presses the head30toward the proximal end direction (Z2direction). Further, the device body18is provided with a fixing member38which supports the head30at a predetermined height in the device body18before the inserting operation of the sensor12and the insertion needle32(movement of the head30) and a guiding member (guide member)40which guides the sensor12and the insertion needle32during the inserting operation.

Further, the push handle22is attached so as to cover the upper side of the housing26and be movable toward the distal end direction by an operation of a user. Further, the dwelling member24includes a base (base portion)42arranged in the slider mechanism28, an engaging arm (engaging plate)44pivotally engaged with the base42, and an adhesive sheet46(adhesive portion) adhering to the bottom surface (distal end surface) of the base42.

The sensor inserting device10according to this embodiment disclosed by way of example allows the components mentioned above to work together with each other so that the sensor12(detector14) is inserted, rather rapidly and securely, into the body through the skin S of the patient, and after the insertion, the sensor12is relatively easily connected to the transmitter16which are then allowed to dwell on the skin S of the patient. The sensor12which is inserted into the body of the patient by the sensor inserting device10detects information about glucose concentration (biological information) included in body fluid of the patient. The detected information about glucose concentration is automatically (or by an operation) transmitted wirelessly via the transmitter16to external medical equipment (e.g., a display or an electronic medical record) to be used for managing blood sugar level of the patient.

The subject to which the sensor inserting device10carries out insertion is not limited to the sensor12for detecting the blood sugar level. For example, the device can be applied to various objects such as insertion and dwelling of a sensor for detecting pH and cholesterol, protein, or the like as the biological information other than the blood sugar level.

In the illustrated embodiment, the sensor12which detects the blood sugar level of the patient is configured as a unit. The sensor unit50is configured with three components, that is, the sensor12, an engaging member52, and a connecting member54.

FIG. 5illustrates the sensor unit50and the insertion needle32in an enlarged manner. As illustrated inFIG. 5, the sensor12includes the detector14which is inserted into the body of the patient to detect a body fluid component of the patient and a sensor base56exposed on the skin S of the patient when the detector14is inserted in the body of the patient.

As for measuring the glucose concentration in the body fluid component by the sensor12, a well-known measurement method can be applied. For example, an enzyme method using a glucose oxidase electrode (GOD) is one possibility. In this case, the detector14is configured with an oxidation-reduction electrode including an enzyme which reacts with blood sugar (e.g., glucose oxidase and glucose dehydrogenase).

When the blood makes contact with the detector14and a reaction between the blood and an enzyme takes place, the glucose (blood sugar) is decomposed into gluconic acid and hydrogen peroxide, and the hydrogen peroxide is decomposed into water and an electron. By detecting the electron thus produced, the glucose concentration in the blood, that is, the blood sugar level can be calculated based on the current value. The configuration of the sensor12(detector14) is not limited to the configuration described above. For example, a configuration may be employed using a fluorescent pigment which produces or reduces fluorescent light by coupling with glucose. The sensor12can suitably be selected among various types according to an analyte component.

The detector14may preferably have flexibility so as that the detector14can rather easily be inserted into the living body of the patient and damage to a living body tissue can be reduced. Further, the length of the detector14may preferably be, for example, 0.2 to 10 mm when insertion is carried out into the body of the patient. The length also depends on a subject to which insertion is carried out (a blood vessel or a living body tissue) or a location of insertion.

Contrary to the detector14inserted underneath the skin of the patient, the sensor base56is a component exposed on the skin S, that is the sensor base56is exposed outside the body. The sensor base56includes a connecting portion56ato which the detector14is connected to be in the distal end (Z1direction) side and a proximal end portion56bcontinuously connected to the connecting portion56aand possessing an approximately square shape. The connecting portion56ais configured to have flexibility so as to allow the sensor base56(proximal end portion56b) to bend in the front-and-rear direction against the detector14. The proximal end portion56bis configured as a connecting surface of the engaging member52and the connecting member54. On a right side surface of the proximal end portion56b, hook holes58are formed to have two different types of rectangular shapes (a rectangle and a square).

The engaging member52is a plate-like member having a predetermined thickness. One of the sides of the engaging member52is formed to have a shape partially overlapping with the sensor base56. Specifically, the engaging member52includes a sensor arrangement portion60on which a portion of the sensor base56is arranged, a sensor side guiding portion62, and a sensor side hook64.

The sensor arrangement portion60is located in an approximately middle portion of the Y direction of the engaging member52. On the surface of the sensor arrangement portion60, two types of sensor retaining protrusions66which engage with two types of hook holes58of the sensor base56are protrudingly formed. That is, the two types of sensor retaining protrusions66protrude away from the surface of the sensor arrangement portion60. The sensor base56is arranged on the surface of the sensor arrangement portion60so that the sensor retaining protrusions66penetrate (are positioned in) and engage with the hook holes58, and thereby the engaging member52is attached and fixed to the sensor12.

The sensor side guiding portion62is located in the right (Y1direction) side of the sensor arrangement portion60and extends toward the Z direction with a thickness smaller than the sensor arrangement portion60. The sensor side guiding portion62is arranged so as to allow guiding by the guiding member40(seeFIG. 3).

The sensor side hook64is arranged in the left (Y2direction) side of the sensor arrangement portion60. The upper portion (proximal end portion) of the sensor side hook64is connected to the side surface of the sensor arrangement portion60, by which the whole sensor side hook64is supported. The distal end portion of the sensor side hook64is flexibly swingable against the connecting portion of the proximal end portion. A forwardly protruding hook64ais provided on the distal end portion of the sensor side hook64, and the hook64ais engaged with the engaging arm44(seeFIG. 3) of the dwelling member24.

The connecting member54is a member which is layered on or overlies the surface of the sensor base56of the sensor12, and includes, in a plan view, a sensor connecting portion68formed in the Y1direction and a sensor side connecting terminal70formed in the Y2direction.

The sensor connecting portion68includes a hook hole68awhich has a shape same as that of the hook hole58of the sensor base56. That is, the sensor unit50is integrated as a unit by the engaging member52, the sensor12, and the connecting member54layered or overlying one another in this order, and the sensor retaining protrusion66of the engaging member52penetrating (positioned in), and engaging with, each of the hook holes58and68aof the sensor12and the connecting member54, respectively.

The sensor side connecting terminal70possesses a trapezoidal shape in which the thickness is greater at the proximal end side and taperingly decreases from approximately the middle portion toward the distal end side. On the tapered surface70a, a conductive terminal which is electrically connectable to the transmitter16is provided. When the sensor12, the engaging member52, and the connecting member54are integrated as in the manner mentioned above (that is, when the sensor12and the connecting member54are layered or positioned in an overlying or overlapping relationship), the contact surface of the connecting member54and the sensor base56becomes electrically conductive so that the sensor unit50can transmit the blood sugar level (current value) detected by the detector14to the connecting member54.

The sensor unit50is attached to the insertion needle32, and contained and supported inside the device body18of the sensor inserting device10. The insertion needle32is fabricated from a rigid metal material (e.g., stainless steel) so as to easily pierce the skin S of the patient. The insertion needle32includes a needle portion72extending toward the distal end (Z1direction) side and an airfoil portion74formed in the proximal end (Z2direction) side of the needle portion72.

Further, the needle portion72and the airfoil portion74of the insertion needle32according to the embodiment are integrally formed by folding a thin metal sheet inward using any suitable forming method (e.g., press forming). In this manner, sufficient strength can be provided, even for a relatively thin metal sheet material, for the insertion needle32, and also, reduction in production cost can be expected.

The needle portion72possesses an acute angle so as to easily pierce the skin S by cutting a portion of the distal end portion of the needle portion72. By folding the metal material inward, the needle portion72possesses an arc-shape cross section with an opening on the side facing the Y1direction. The inner surface of the arc-shape extends along the axial direction to form an insertion needle side groove76. The insertion needle side groove76extends from the distal end to the proximal end of the insertion needle32including the airfoil portion74and temporary holds the detector14of the sensor12.

The airfoil portion74is a rectangular component in which the thin sheet metal material is folded in the direction opposite to that of the insertion needle side groove76. The airfoil portion74is formed to have two (a pair of) overlapping airfoil portions74. The pair of airfoil portions74extends toward the Y2direction with a space, between each other, approximately the same as the thickness of the head side support plate144(seeFIG. 3) of the head30. Further, on each plane portion of the pair of airfoil portions74, a rectangular insertion needle side attaching hole78is drilled.

As illustrated inFIG. 4andFIG. 5, the insertion needle32is supported in the device body18with the sensor unit50temporarily held in the insertion needle side groove76. The sensor inserting device10carries out insertion (piercing) of the detector14and the insertion needle32into the body of the patient by the movement, caused by the movement mechanism20, of the sensor unit50and the insertion needle32in the distal end direction (Z1direction). Now, each component of the sensor inserting device10which carries out insertion of the sensor unit50and the insertion needle32will specifically be described.

As illustrated inFIG. 6AandFIG. 6B, the housing26extends in the up-and-down direction (Z direction) and constitutes a frame of the sensor inserting device10. The housing26is preferably made of a resin material having relatively high rigidity so that the movement mechanism20, the fixing member38, and the guiding member40(seeFIG. 3) can be supported inside the frame. In the housing26, a proximal end cylindrical portion80, an extending portion82, and a distal end attachment portion84are formed in this order from the top side toward the bottom side.

The proximal end cylindrical portion80of the housing26possesses a bottomed cylindrical shape having an upper bottom portion80ahaving an elliptical shape, in a plan view, constituting an upper end of the housing26and a side circumferential portion80bextending from the rim of the upper bottom portion80atoward the distal end side. In the proximal end cylindrical portion80, the upper bottom portion80aand the side circumferential portion80bsurround an internal space86having an approximately rectangular shape, in a plan view, penetrating the proximal end cylindrical portion80in the up-and-down direction. An operating bar180(FIG. 3) of the push handle22is contained in the internal space86via a top surface opening of the upper bottom portion80a. Further, in the proximal end cylindrical portion80, the inner surface of a pair of inner walls86acovering the width direction (Y direction) side of the internal space86possesses a rack shape (seeFIG. 3, etc.). Specifically, each of the pair of inner walls86ahas three stages of a tooth88(i.e., each of the inner walls possesses three teeth). In each stage, the thickness of the tooth88taperingly increases from the proximal end side toward the distal end side (hereinafter, each tooth is referred to as, from the proximal end side, a first tooth88a, a second tooth88b, and a third tooth88c).

The pair of extending portions82of the housing26is provided on the side circumferential portion80bof the proximal end cylindrical portion80in the major axis (Y direction) sides of the elliptical shape. The pair of extending portions82extends toward the distal end direction by a predetermined distance, and the distal end attachment portion84is formed on the distal end portion of the extending portion82. The extending portion82possesses an arc-shape cross section corresponding to the side circumferential portion80bof the proximal end cylindrical portion80, thereby providing sufficient rigidity. Further, the extending portion82has a pair of proximal end side protruding portions90protruding inward at a location spaced, by a predetermined distance, from the distal end surface of the proximal end cylindrical portion80. Therefore, a gap90ahaving a predetermined space exists between the distal end surface of the proximal end cylindrical portion80and the top surfaces of the pair of proximal end side protruding portions90. The fixing member38(seeFIG. 3) is arranged in the gap90a.

The distal end attachment portion84of the housing26is a component which is attached to, and supports, the slider mechanism28(seeFIG. 3). The distal end attachment portion84is configured with a pair of attachment arms92continuously connected to the distal end portion of the pair of extending portions82and extending in the front-and-rear direction (X direction). Each attachment arm92includes an upper plate92aextending in the front-and-rear direction and the width direction from the extending portion82, a side plate92bextending from the outer edge of the upper plate92atoward the distal end side, an engaging plate92cextending further outward from the side plate92b, and a longitudinal plate92dperpendicular to the engaging plate92cat the rear side of the side plate92b. The adjacent plates stiffen each other so that the rigidity of the attachment arm92is improved. The pair of attachment arms92is provided with a housing side recess94(seeFIG. 6B) at a predetermined location in the inner surface of the side plate92b(in the rear side and approximately in the middle portion in the up-and-down direction of the side plate92b).

As illustrated inFIG. 3andFIG. 7, the slider mechanism28of the device body18is a mechanism in which, before an inserting operation of the sensor12(sensor unit50) and the insertion needle32, the dwelling member24is supported just below the housing26(distal end portion) and at the same time the transmitter16is supported in front (in the X1direction) of the dwelling member24, and after the inserting operation, the transmitter16is allowed to slide toward the dwelling member24.

The slider mechanism28includes a slider mechanism body96which is attached to the housing26, a slider98which is allowed to move relative to the slider mechanism body96, and a slider spring100which gives thrust to (presses) the slider98toward the X2direction.

The slider mechanism body96includes, in the distal end (Z1direction) side, a body base102possessing a plate-like shape. The body base102is configured with a rear floor102ahaving an approximately elliptical shape in a plan view and a rectangular front floor102bcontinuously connected to the side, in the minor axis direction (the forward side), of the elliptical shape. The top surface of the body base102in which the rear floor102aand the front floor102bare continuously connected is provided as a transmitter arrangement portion120. Further, in the approximately middle portion of the rear floor102a, a rectangular dwelling member window104is drilled so as to have a size approximately the same as the plane shape of the dwelling member24. The dwelling member24is previously arranged in the dwelling member window104. Further, on the top surface of the body base102, a pair of side walls106, a rear wall108, and a pair of slider guides110are arranged.

The pair of side walls106is vertically provided at both ends, in the major axial direction (Y direction), of the rear floor102a, and extends in the front-and-rear direction (X direction) approximately parallel to each other. A brim106aprotruding inward is provided on an upper end portion of each side wall106, and a gap106bis formed between the brim106aand the body base102. When the housing26is attached to the slider mechanism body96, the engaging plate92c(seeFIG. 6A) of the attachment arm92is inserted or positioned in the gap106b.

The rear wall108is located in the rear of, and between, the pair of side walls106and provided to extend in the direction perpendicular to the direction toward which the side wall106extends. A slider inserting hole112penetrating the rear wall108in the front-and-rear direction is provided on each side, in the width direction (Y direction), of the rear wall108. Further, a spring arrangement hole114in which the slider spring100is positioned is extends into and opens to the rear surface side, in the middle portion in the width direction, of the rear wall108.

Further, on the top surface, and in the middle portion in the width direction, of the rear wall108(above the spring arrangement hole114), a slider engaging portion116is formed. The slider engaging portion116is configured with a rectangular bar having a predetermined thickness. The slider engaging portion116extends upward from the top surface of the rear wall108, and then, at a predetermined height, extends rearward to form a U-shape in a plan view. The slider engaging portion116functions as an engaging mechanism which restricts sliding of the slider98.

Furthermore, a slider mechanism side protrusion118is protrudingly formed on the side surface, in the width direction, of the rear wall108. The slider mechanism side protrusion118engages with the housing side recess94(seeFIG. 6B) when the housing26and the slider mechanism body96are attached, thereby further strengthening the attachment.

The pair of slider guides110extend parallel to each other between the pair of side walls106and in front of the dwelling member window104. A transmitter arrangement portion120is formed between the pair of slider guides110.

Further, a slider98of the slider mechanism28is attached in a manner that the slider98is allowed to slide in the front-and-rear direction (X direction) against or relative to the slider mechanism body96. The sliding operation of the slider98is carried out to move the transmitter16which is arranged in the transmitter arrangement portion120to be connected (integrated) with the dwelling member24which is previously arranged in the dwelling member window104(also seeFIG. 19AtoFIG. 19C).

The slider98possesses an approximate U-shape in a plan view and is attached to the slider mechanism body96so as to surround the rear wall108and the slider guide110of the slider mechanism28described above. The slider98includes a slider side connecting portion122extending toward the right-and-left width direction (Y direction), a pair of support arms124extending forward from both the right-and-left ends of the slider side connecting portion122, a slider spring supporting protrusion126which supports the slider spring100, and a slider controlling plate128which controls a timing of the movement of the slider98.

The slider side connecting portion122has a width in the longitudinal direction (Y direction) corresponding to the length between the pair of slider inserting holes112of the slider mechanism body96, and bridges the pair of support arms124located at both ends. In the middle portion in the width direction of the slider side connecting portion122, the slider spring supporting protrusion126and the slider controlling plate128are provided.

The pair of support arms124are each a plate-shaped member and extend parallel to each other and toward the forward direction (X1direction) from the slider side connecting portion122. A slider side hook130is provided on the forward end of each of the pair of support arms124. Each slider side hook130protrudes inward from the inner surface of the support arm124and is formed so as that the rear end surface of the protrusion is perpendicular to the support arm124. Further, only the upper side of the slider side hook130is connected to the inner surface of the support arm124. The lower side of the slider side hook130is provided with a hollow (groove)131in which the slider guide110can be inserted.

Further, on the portion of the inner surface of each of the pair of support arms124close to the slider side connecting portion122, a rib132extends in the lengthwise direction of the support arm124. The ribs132support the dwelling member24with the dwelling member24arranged in the dwelling member window104before the inserting operation of the sensor12and the insertion needle32. The ribs132are connected to the slider side connecting portion122so as to suppress the swinging of the support arm124, which also functions as a stiffening member for keeping the parallel state.

Further, the slider spring supporting protrusion126is a column-shape component protruding forward from the front surface of the slider side connecting portion122and facing the spring arrangement hole114when the slider98is assembled to the slider mechanism body96. Further, the slider controlling plate128extends forward by a predetermined height from the top surface of the slider side connecting portion122, and is flexibly deformable in the up-and-down direction. On the forward portion of the slider controlling plate128, a stepped portion128ahaving a greater thickness than the rear portion is formed. The stepped portion128acan engage with the slider engaging portion116(rectangular bar) of the slider mechanism body96.

In the slider mechanism28, the slider side connecting portion122is arranged in the rear of the rear wall108with the slider98and the slider spring100assembled in the slider mechanism body96. Further, the pair of support arms124extends forward through the slider inserting holes112, further advancing over the pair of slider guides110, and reaching the front end portion of the front floor102bof the body base102.

Further, one end of the slider spring100is inserted in the spring arrangement hole114of the slider mechanism body96, and the other end of the slider spring100is engaged with the slider spring supporting protrusion126of the slider98.

Further, the slider controlling plate128of the slider98engages with the slider engaging portion116of the slider mechanism body96. That is, the movement (sliding) of the slider98is restricted by the stepped portion128ahooked in the rectangular bar of the slider engaging portion116. When the sliding is restricted, the slider spring100is arranged in a compressed state. Therefore, in this state, the slider spring100gives thrust to the slider side connecting portion122of the slider98to move farther from the rear wall108(rearward).

In the manner described above, the slider mechanism28causes the slider98to slide rearward at a predetermined timing by assembling the slider mechanism body96, the slider98, and the slider spring100. Further, in the slider mechanism body96, when assembling the slider98, the dwelling member24is assembled so as to overlap with or overlie the dwelling member window104.

In the device body18, the slider mechanism28to which each of the members is assembled as described above is attached to the distal end attachment portion84of the housing26(also seeFIG. 6AandFIG. 6B). In this case, the slider mechanism body96is inserted in the pair of attachment arms92from the front side. Specifically, the engaging plate92cof the attachment arm92is engaged with the brim106aof the side wall106and the gap106bof the body base102, and then the slider mechanism body96is inserted rearward. In this manner, the attachment arm92is held between the side surface of the rear wall108and the side surface of the side wall106. In this state, by inserting (sliding) the slider mechanism28, the slider mechanism28is attached to the housing26. At this time, when the insertion is carried out until the rear end surface of the side wall106of the slider mechanism28makes contact with the longitudinal plate92dof the attachment arm92, the slider mechanism side protrusion118of the slider mechanism body96engages with the housing side recess94. In this manner, disengagement of the slider mechanism28from the housing26can be prevented.

Referring again toFIG. 3, the movement mechanism20provided in the device body18includes the head30, the advance spring34, and the return spring36. The head30is arranged so as to be movable in the up-and-down direction in the device body18(housing26).

As shown inFIGS. 8A and 8B, the head30includes an elliptical plate (head base)134having an elliptical shape in a plan view, head side guides136formed on both ends of the major axial direction (Y direction) of the elliptical plate134, a pair of head side arms138extending upward (Z2direction) from the top surface of the elliptical plate134, a lower side protrusion140protruding downward (Z1direction) from the bottom surface of the elliptical plate134, a plurality of head side inserting holes142penetrating the elliptical plate134, and head side support plates144protruding further downward from the bottom of the lower side protrusion140. The head30is arranged between the pair of extending portions82(seeFIG. 4) so as to slide in the up-and-down direction.

The elliptical plate134is a base having the head side guide136, the head side arm138, and the lower side protrusion140on the surface. The elliptical plate134is configured as a component which receives the thrust (pressing force) from the advance spring34and the return spring36which are force producing sources of the movement mechanism20. The elliptical plate134can be formed of the same material as the housing26, and is formed so as to have the dimension in the major axial direction approximately same as the inner diameter of the pair of extending portions82and a predetermined thickness. In this manner, the elliptical plate134is provided with sufficient rigidity so that the shape of the elliptical plate134can be retained even when the thrust from the advance spring34and the return spring36is applied.

The pair of head side guides136formed on both ends of the elliptical plate134extends upward (Z2direction) from the top surface of the elliptical plate134. The outer surface of the head side guide136is an arc-shape which is approximately the same as the inner surface of the extending portion82. That is, by the outer surface of the pair of head side guides136sliding against the inner surface of the extending portion82, movements in the front-and-rear and right-and-left directions and the rotation of the head30are restricted so that the head30is guided to move only in the up-and-down direction.

The pair of head side arms138is provided in the approximately middle (axial center) of the elliptical plate134, and extends upward via the lower side connecting portion138acontinuously connected to the elliptical plate134and a plate-like extending portion138bconstituting the middle portion. A head side hook146is formed on the upper end portion of the head side arm138. The head30is supported at approximately the middle portion of the housing26by the head side hook146engaging with the fixing member38(seeFIG. 4).

Further, the pair of head side arms138is arranged so as that the pair of head side arms138is adjacent to each other in the front-and-rear direction (X direction) in a side view (seeFIG. 8B) and the plate-shaped extending portions138boverlap each other in a front view. Further, the lower side connecting portion138ahas a tapered shape in which the width is larger in the portion connected to the elliptical plate134and becomes smaller toward an upper portion. Thereby, the lower side connecting portion138ais stiffened so that the swinging of the tapered surface side of the head side hook146is restrained. Furthermore, each of the pair of head side hooks146has a hooking portion protruding in the same direction as the tapered shape of the lower side connecting portion138a. In the front view, the hooking portions protrude toward the opposite side to each other. That is, when the head side arm138engages with the fixing member38, the central axis of the head30is firmly supported, and thereby the disengagement of the head side hook146caused by an effect other than a predetermined operation (e.g., vibration of the sensor inserting device10or an impact of external force) can be prevented.

Further, the lower side protrusion140is formed on the column-like portion protruding by a predetermined distance from the middle portion of the bottom surface of the elliptical plate134.

Further, the head side inserting holes142provided on the elliptical plate134are drilled or located at four (front, rear, right, and left) locations surrounding the head side arm138. The four head side inserting holes142, at locations facing each other with the head side arm138in between, have the same shape. Specifically, a pair of first head side inserting holes142alocated on the major axial direction of the elliptical plate134each possess an approximately rectangular shape, and second head side inserting holes142blocated on the minor axial direction each possess an approximately square shape. First and a second guide arms166and168of the guiding member40(seeFIG. 3) are inserted in each pair of head side inserting holes142aand142b.

The head side support plate144has a function to attach and support the insertion needle32, and is provided in the left (Y2direction) side, in a front view, of the bottom of the lower side protrusion140. The head side support plate144is plate-shaped and protrudes downward (distal end direction). Further, on both sides of the plate of the head side support plate144, an engagement protrusion148formed in a tapered shape having a smaller thickness toward the lower portion is provided. The engagement protrusion148possesses a rectangular shape which is approximately the same as the shape, in a front view, of the insertion needle side attaching hole78(seeFIG. 5) of the insertion needle32. The insertion needle side attaching hole78engages with or is positioned in the engagement protrusion148. That is, when the insertion needle32is attached to the head30, the head side support plate144is sandwiched between the two airfoil portions74of the insertion needle32and the engagement protrusion148is inserted into the insertion needle side attaching hole78. In this manner, the insertion needle32is firmly supported by the head30.

Referring again toFIG. 4, in the movement mechanism20according to the embodiment disclosed by way of example, regarding the head30, the advance spring34is arranged in the upper side of the elliptical plate134and the return spring36is arranged in the lower side of the elliptical plate134. In this case, the elastic force of the advance spring34is larger than the elastic force of the return spring36.

The advance spring34is arranged to surround the pair of head side arms138between the elliptical plate134of the head30and the fixing member38. The advance spring34is shorter than the head side arm138. However, when the head30is engaged with the fixing member38(before inserting operation of the sensor unit50and the insertion needle32), the advance spring34is compressed in the axial direction so as to give downward thrust to the elliptical plate134(that is, head30). Therefore, the advance spring34functions as a force producing source for moving the head30toward the distal end direction before the inserting operation, and provides a piercing force to insert (make piercing with) the sensor unit50and the insertion needle32into the body of the patient at the distal end of the device body18.

Further, the return spring36is arranged to surround the periphery of the guiding member40on the top surface of the distal end attachment portion84of the housing26. In this case, the return spring36is not in contact with the head30before the inserting operation of the sensor unit50and the insertion needle32. Further, when the head30moves toward the distal end direction as the inserting operation proceeds, the return spring36is compressed and produces thrust to push the head30back toward the proximal end direction.

In this manner, in the movement mechanism20, the head30is supported at an approximately middle location in the housing26(standby position) by the fixing member38before the inserting operation of the sensor unit50and the insertion needle32. When the supported state is cancelled by a predetermined operation, the movement toward the distal end direction guided along the guiding member40is produced.

The fixing member38is arranged in the gap90a(seeFIG. 6A) between the proximal end cylindrical portion80and the proximal end side protruding portion90of the housing26, and has a function of supporting the head30before the inserting operation of the sensor unit50and the insertion needle32as described above. As illustrated inFIG. 9AtoFIG. 9C, the fixing member38includes a middle disk (fixing base)150provided in an approximately middle portion in the up-and-down direction, a pair of fixing member side arms152extending upward from the top surface of the middle disk150, and a pair of guiding feet154extending downward from the bottom surface of the middle disk150.

The middle disk150is configured as a component receiving the thrust (pressing force) from the advance spring34and formed in a disk-like shape of which outer diameter and thickness are approximately the same as those of the gap90aof the housing26. Therefore, the fixing member38is inserted in the gap90a, and thereby firmly fixed and supported in the housing26. Further, in the approximately middle portion of the middle disk150, a rectangular fixing member side inserting hole156is drilled located. In the fixing member side inserting hole156, the pair of head side arms138(seeFIG. 8A) is inserted.

The pair of fixing member side arms152is formed at sides of the fixing member side inserting hole156, in the right-and-left width direction (Y direction), in a plate-like shape with a smaller thickness in the front-and-rear direction and extends upward by a predetermined distance. On the upper portion of the fixing member side arm152, a supporting protrusion158with which the head side hook146of the head side arm138engages is inwardly formed. The pair of the fixing member side arms152is arranged to be offset to each other in the front-and-rear direction, in a side view, corresponding to the arrangement of the head side arm138. Further, the supporting protrusion158is formed in a tapered shape in which the width increases inward from a predetermined location close to the upper portion so that tilting toward the inner side is restrained, thereby providing further firm engagement of the head side hook146.

The pair of guiding feet154is connected to the bottom surface of the middle disk150and extend downward by a predetermined distance. The pair of guiding feet154is formed in a location displaced in a circumferential direction of the middle disk150by 90 degrees from the fixing member side arm152. Further, as illustrated inFIG. 9C, a fixing member side groove160is located on the outer side in the width direction and along the extending direction of the guiding foot154. A fixing member side hook162protruding outward is provided in the lower side of the fixing member side groove160. The fixing member side hook162engages with the second guide arm168of the guiding member40.

As illustrated inFIG. 10AtoFIG. 10C, the guiding member40has a function of guiding the movement of the head30toward the distal end direction during the inserting operation of the sensor unit50and the insertion needle32, and is configured to move toward the proximal end direction with the head30after the inserting operation of the sensor unit50and the insertion needle32. To provide such operation, the guiding member40is configured to include a ring portion164formed in the lower side, the pair of first guide arms166extending upward from both ends in the right-and-left width direction (Y direction) of the ring portion164, and the pair of second guide arms168extending upward from both ends in the front-and-rear direction (X direction) of the ring portion164.

The ring portion164is ring-shaped having a predetermined thickness, and vertically supports the first and second guide arms166and168. Before the inserting operation of the sensor unit50and the insertion needle32, the ring portion164is arranged inside the distal end portion (pair of attachment arms92) of the housing26(seeFIG. 4). Further, as illustrated inFIG. 10C, the inner circumference surface of the ring portion164in the vicinity of the first guide arm166includes an upright groove170which engages with the engaging arm44to support the upright position.

The pair of first guide arms166is formed to have a cross-section, which allows the first guide arm166to be inserted in the first head side inserting hole142a(seeFIG. 8A) of the head30, and extends upward by a predetermined distance. Further, the upper end of the first guide arm166is notched so as to form a tapered shape on the outer side in the width direction. Further, the first guide arm166has a swingably engaging plate172which is swingable, along the notched surface, in the width direction.

One end of the swingably engaging plate172is connected to the upper end of the first guide arm166, and the other end of the swingably engaging plate172can swing about the connecting portion. That is, before the inserting operation of the sensor unit50and the insertion needle32, the swingably engaging plate172spreads out in the width direction so that the other end makes contact with the inner surface of the extending portion82. Then, by the inserting operation (movement of the head30toward the distal end direction), the swingably engaging plate172swings toward the closing direction (direction toward the first guide arm166) by making contact with the head side inserting hole142, thereby allowing the head30to pass. Further, when the head30moves toward the proximal end direction, the other end of the swingably engaging plate172makes contact with the head side guide136, thereby transmitting the force of motion toward the proximal end direction from the head30to the guiding member40, so that the guiding member40moves toward the proximal end direction with the head30.

Furthermore, each inner side of the pair of first guide arms166includes an arm groove174which extends from the upper portion of the first guide arm166to the lower end of the ring portion164continuously connected to the first guide arm166. In one of the pair of arm grooves174, a sensor side guiding portion62of the sensor unit50(seeFIG. 5) is inserted, and in the other arm groove174in the opposite side, a head side support plate144of the head30is inserted. That is, the guiding member40can guide the sensor unit50and the insertion needle32toward the distal end direction by the arm groove174when the head30moves. In the approximately middle portion of the arm groove174, a temporary-engaging protrusion174aslightly protrudes inward. The temporary-engaging protrusion174amakes contact with the distal end portion of the sensor side guiding portion62of the sensor unit50before the inserting operation of the sensor unit50and the insertion needle32so that disengagement of the temporarily held sensor unit50from the insertion needle32can be prevented.

The pair of second guide arms168is formed to have a cross section which allows the insertion in the second head side inserting hole142bof the head30. Each second guide arm168extends by a length approximately the same as that of the pair of first guide arms166and has, on the upper end, a guiding member side hook176protruding inward. The second guide arms168enter the respective fixing member side groove160formed on the guiding foot154of the fixing member38so that the guiding member side hook176engages with the fixing member side hook162. Thereby, the guiding member40is supported by the fixing member38, but the movement toward the distal end direction is restricted. Further, when the guiding member40moves toward the proximal end direction, the fixing member side groove160guides the second guide arm168(guiding member side hook176).

Referring again toFIG. 2andFIG. 4, a push handle22is attached to the proximal end (Z2direction) side of the device body18(housing26) of the sensor inserting device10. The push handle22has a function of releasing the engagement of the head30supported by (engaged with) the fixing member38when the inserting operation of the sensor unit50and the insertion needle32is carried out. The push handle22is attached so as to be allowed to move toward the distal end direction (Z1direction) relative to the device body18. This displacement releases the engagement of the head30. That is, in the movement mechanism20, the movement of the head30toward the distal end direction (inserting operation) is carried out by the operation of the push handle22.

As illustrated inFIG. 3andFIG. 11AtoFIG. 11C, the push handle22according to the illustrated embodiment disclosed by way of example includes an outer cylinder178, possessing a bottomed cylindrical shape and covering the upper portion of the device body18(housing26), and the pair of operating bars180provided inside the outer cylinder178.

The outer cylinder178is attached so as to cover the upper portion (proximal end side) of the device body18. The upper bottom portion178aof the outer cylinder178possesses, in a plan view, an elliptical shape whose area is somewhat larger than that of the proximal end cylindrical portion80of the housing26. A side circumferential portion178bcontinuously connected to the periphery of the upper bottom portion178asurrounds the proximal end cylindrical portion80and a portion of the extending portion82and extends toward the distal end (Z1direction). Further, a notch182is formed in the rear surface (X2direction) side of the side circumferential portion178b, close to the distal end portion, of the outer cylinder178. Further, a push handle side pressing plate184extending toward the distal end direction is provided on the top side of the notch182. The push handle side pressing plate184is formed in a shape which allows the distal end portion of the push handle side pressing plate184to be inserted in the slider engaging portion116of the slider mechanism28. The push handle side pressing plate184extends somewhat longer than the distal end of the side circumferential portion178b. When the push handle22is attached to the device body18, the distal end portion and the slider controlling plate128of the slider mechanism28face each other.

Further, the pair of operating bars180hangs toward the distal end side from the bottom surface of the upper bottom portion178a. The operating bar180includes an operating bar side connecting portion180awhich is connected to the outer cylinder178at the upper side, a middle swinging portion180bwhich extends toward the distal end from the operating bar side connecting portion180a, and an operating bar side hook186formed on the distal end portion. The operating bar side connecting portion180apossesses a tapered shape, in which the width is larger at the proximal end side and becomes smaller toward the distal end side, and firmly supports the middle swinging portion180band the operating bar side hook186. In the illustrated embodiment, the operating bar side connecting portion180a, the middle swinging portion180b, and the operating bar side hook186of each operating bar180are integrally formed in one piece at the same time as a single unit. The middle swinging portion180bis formed in a thin plate-shape and continuously connected to the operating bar side connecting portion180aso that the operating bar side hook186on the distal end portion can swing in the thickness direction.

The pair of the operating bar side hooks186includes a hooking portion186aprotruding outward in the width direction and a contact portion186bprotruding inward in the width direction from the opposite side of the hooking portion186a. The pair of the hooking portions186ais formed in a shape which allows engagement with the plurality of teeth88surrounding the internal space86of the housing26(a right triangular shape having an inclined surface and an engaging surface). Further, the pair of contact portions186bis formed in a rectangular protruding piece187having a thickness smaller than the thickness in the front-and-rear direction of the hooking portion186a. The pair of the contact portions186bis provided in locations so as not to overlap with each other in the front-and-rear direction (X direction). Specifically, for the operating bar180in the left side in a front view, the protruding piece187is positioned close to the rear side of the hooking portion186a, and for the operating bar180in the right side, the protruding piece187is positioned close to the front side of the hooking portion186a.

As illustrated inFIG. 4, by attaching the push handle22to the housing26so as to cover the housing26from above, the operating bar180is inserted toward the internal space86through the top surface opening. In this process, as for the operating bar180of the push handle22, the operating bar side hook186is guided along the top surface opening, and the hooking portion186aengages with the upper bottom portion80a(wall surface) of the housing26. In this state, the inclined surface of the hooking portion186aof the operating bar side hook186makes contact with the inclined surface of the first tooth88a, thereby restraining looseness of the operating bar180(that is, the push handle22). By the engagement of the operating bar180, the disengagement of the push handle22from the housing26is prevented.

Further, when the inserting operation of the sensor unit50and the insertion needle32is carried out, by displacing the push handle22toward the distal end direction of the device body18(that is, pushing the push handle22toward the distal end direction), the operating bar180is displaced simultaneously. When the displacement is carried out, the operating bar side hook186deflects inward so as to go over the first tooth88a. By virtue of this inward deflection, the contact portion186bof the operating bar180contacts the head side arm138(head side hook146). As for the contact portion186b, since each of the pair of protruding pieces187is provided in a location offset from each other in the front-and-rear direction as described above, each protruding piece187has an offset in the front-and-rear direction between the arrangement of the fixing member side arm152of the fixing member38(seeFIG. 11C). Therefore, even when the protruding piece187deflects inward, the collision against the fixing member side arm152of the fixing member38is avoided. That is, the protruding piece187only makes contact with the head side hook146so as to release the engagement of the head side hook146from the fixing member side arm152. In this manner, the head30is separated from the fixing member38.

Now, the dwelling member24which allows the sensor unit50to dwell on the skin S of the patient and the transmitter16which is connected to the sensor unit50will specifically be described. As described above, the dwelling member24is a member which supports and allows the sensor unit50and the transmitter16to dwell on the skin S of the patient. The dwelling member24includes the base42arranged in the slider mechanism28, the engaging arm44rotatably supported by the base42, and the adhesive sheet46(seeFIG. 3) which sticks on the skin S of the patient and allows the base42to dwell on the skin S of the patient.

As illustrated inFIG. 12AandFIG. 12B, the base42is formed in a shape which allows the transmitter16to be inserted from the front side. That is, by the sliding operation of the transmitter16provided by the slider mechanism28, the transmitter16is inserted in the base42. The base42includes a floor190formed in a rectangular shape in a plan view located on a bottom side, a pair of side walls192vertically arranged on both ends of the floor190in the longitudinal direction (Y direction), a rear wall194which connects the pair of side walls192, a base side pivot support196formed in an approximately middle portion of the floor190, and a containing hole198drilled on and passing through the floor190adjacent to the base side pivot support196.

The surface of the floor190surrounded by the side wall192and the rear wall194is configured to be an arrangement surface of the transmitter16.

The pair of side walls192extends along the short direction of the floor190parallel to each other. A pair of supporting grooves200is formed on the inner side of the pair of side walls192, and a pair of guiding grooves202is further formed on the sides, opposite to the pair of the supporting grooves200, of the pair of the side walls192(outer side in the longitudinal direction of the floor190). Further, in the inner surface of the side wall192close to the rear side, a base side protrusion204protruding inward is provided.

The supporting groove200is formed to have a width in which a side protrusion218of the transmitter16(seeFIG. 3), which will be described below, can be inserted. That is, when the transmitter16is slidably inserted in the base42, the supporting groove200and the side protrusion218engage each other so that the transmitter16is supported in the base42(dwelling member24). Further, the guiding grooves202possess a width allowing the ribs132(seeFIG. 7) of the slider98to be inserted into the guiding grooves202. When the base42is arranged in the slider mechanism28, the inner wall surface forming the dwelling member window104restricts movements of the base42in the front-and-rear and right-and-left directions. And the rib132restricts the movement of the base42in the up-and-down direction so that the dwelling member24is supported in the slider mechanism28(seeFIG. 3). Further, during the sliding operation of the slider98, the slider98is guided by the guiding groove202.

As illustrated inFIG. 12A, the rear wall194connecting the side walls192determines the slide limit of the transmitter16.

The base side pivot support196is a component which pivotally supports engaging arm44and includes a notched groove206formed on the floor190so as to continuously connect the containing hole198and a pair of opposingly positioned pivotally supporting protrusions208. The protrusions are disposed at locations along opposite sides of the notched groove206so that the notched groove206is between the protrusions208, and so that the protrusions208are slightly higher than the top surface of the floor190. Each of the pivotally supporting protrusions208is positioned in the pivot hole214aof the engaging arm44so as to pivotally support the engaging arm44. Further, the notched groove206functions as a space for avoiding interference when the engaging arm44rotates.

The containing hole198is rectangular-shaped and is provided on the floor190at a position in a region spaced from an approximately middle portion toward the left side (Y2direction). The plane shape of the containing hole198has dimensions larger than the width and height dimensions of the engaging arm44in a front view. That is, the containing hole198can contain or receive the engaging arm44when the engaging arm44turns and rotates down to be flat.

Further, the engaging arm44includes an extending engaging portion210formed in the Y1direction and an L-shape portion212extending toward the Y2direction from the side of the extending engaging portion210.

The bearing214is provided on the lower (Z1direction) side of the extending engaging portion210. An engaging arm side hook216is formed on the upper portion extending from the bearing214. The bearing214has a pivot hole214apenetrating in the width direction and open at both ends. Each of the pivotally supporting protrusions208is positioned the pivot hole214awhen the engaging arm44is attached to the base42. Further, the engaging arm side hook216is hooked on the hook64aof the sensor side hook64(seeFIG. 5) when the sensor unit50moves toward the distal end direction.

The L-shape portion212extends toward the Y2direction by a length long enough to be inserted in the upright groove170on the inner surface of the ring portion164of the guiding member40(seeFIG. 10C) and then, from the end portion, extends upward to form the shape (L-shape). The L-shape portion212is supported by the upright groove170in the inner side of the first guide arm166. Thereby, the engaging arm44is supported to stand upright from the base42before the inserting operation of the sensor unit50and the insertion needle32.

Referring again toFIG. 3, an adhesive having sufficient adhesion for sticking on the skin S of the patient without coming off easily is coated on the bottom surface (surface facing the distal end) side of the adhesive sheet46. Further, the adhesive is also coated on the portion, directly facing the base42, of the top surface (surface facing the proximal end) side of the adhesive sheet46. Therefore, the dwelling member24with the adhesive sheet46adhered on the base42can be arranged in the slider mechanism28(seeFIG. 1).

As illustrated inFIG. 13A, the transmitter16includes an approximately rectangular-shaped case which is inserted or positioned in, and supported by, the base42. Inside the case of the transmitter16, an electric (electronic) circuit structure which processes the blood sugar level (current value) detected by the sensor unit50(detector14of the sensor12) illustrated inFIG. 5is provided. In this case, the component of the electric circuit may be a current/voltage converter which converts a current value detected by the detector14of the sensor into a voltage value, an amplifier which amplifies a voltage value, a transmitter which externally transmits a voltage value (signal value) wirelessly (or wired), a battery which supplies power to each components, or a circuit substrate for electrically connecting components. Various configurations may be employed for the structure of the electric circuit and, for example, a microcomputer or the like which carries out a predetermined processing of a signal value may be implemented in the circuit substrate.

Both ends of the transmitter16, in the longitudinal direction (Y direction) of the transmitter16, are provided with a side protrusion218having a smaller thickness than the thickness of the main body. The protrusions208protrude outwardly or extend away from the main body. The side protrusions218engage with the supporting grooves200of the base42(seeFIG. 12A) so that the transmitter16is supported by the base42. Further, at a predetermined location on each side surface of the transmitter16close to the rear portion, a transmitter side recess220is formed. The transmitter side recesses220engage with the base side protrusion204of the base42when the transmitter16is slidably inserted so that the disengagement of the transmitter16from the base42can be prevented.

Further, a connecting terminal recess222is provided in the bottom surface of the transmitter16toward the rear portion of the transmitter16. The sensor unit50(seeFIG. 5) is inserted in the connecting terminal recess222. The connecting terminal recess222is located in the region from an approximately middle portion in the width direction, in a plan view, toward the right (Y1direction) side. That is, the connecting terminal recess222is not centered in the bottom surface of the transmitter, but rather is located closer to one side, namely the right side inFIG. 13A. The connecting terminal recess222includes a first space222apossessing a rectangular shape and opening to the bottom surface of the transmitter16and a second space222bwhich is continuously connected to or in communication with the upper side of the first space222aand has a relatively smaller area in a plan view. The first space222ais configured to contain or receive the sensor12and the engaging member52of the sensor unit50. The second space222bis configured to contain or receive the connecting member54. Note that, in the transmitter16, the front portion side of the second space222bis configured as a tapered surface224which is a conductive connecting surface configured to make electrical connection with the connecting member54(conductive terminal). Further, the second space222bpossesses a tapered shape expanding toward the rear side so that the connecting member54can be slidably inserted with ease.

The sensor inserting device10according to the embodiment is configured as described above. Now, the operation of insertion and dwelling of the sensor12using the sensor inserting device10will be described.

FIG. 14illustrates a transmitter16to be attached when using the sensor inserting device10according to the embodiment described above.

When the sensor inserting device10is used, the sensor unit50and the insertion needle32are previously attached to the movement mechanism20inside the device body18, and the arrangement of the transmitter16to the sensor inserting device10in which the slider mechanism28and the dwelling member24is attached to the distal end portion of the device body18(the state the product is provided) is carried out.

In the state the product is provided, the safety mechanism226is provided to the sensor inserting device10so that the displacement (movement) of the push handle22toward the distal end direction (downward direction inFIG. 14) is restricted. The safety mechanism226according to the illustrated embodiment is configured as a fixing support bar226aprovided between the transmitter arrangement portion120of the slider mechanism28and the distal end of the push handle22. The safety mechanism226restricts (prevents) the displacement or axial movement of the push handle22by virtue of the fixing support bar226asupporting the push handle22on the transmitter arrangement portion120, and further prevents arrangement of the transmitter16. That is, in addition to preventing the axial movement of the push handle22, the fixing support bar226aprevents the transmitter from being moved into the position shown inFIG. 1. To attach or position the transmitter16at the position shown inFIG. 1, the fixing support bar226aneeds to be removed. In this manner, a trouble such as forgetting to release the safety mechanism226when the sensor inserting device10is to be used can be avoided.

After the transmitter16is attached to the sensor inserting device10, the sensor inserting device10is positioned at a suitable location (location in which the sensor12is to be inserted) on the skin S of the patient as illustrated inFIG. 1.

FIG. 15illustrates a first state of the sensor inserting device before the inserting operation of the sensor unit50and the insertion needle32.

At a state in which the sensor inserting device10is positioned on the skin S of the patient, the operating bar180of the push handle22is positioned at the uppermost of the internal space86of the housing26as illustrated inFIG. 15. Further, the sensor inserting device10is in the first state in which the sensor unit50and the insertion needle32are supported by the head30at a position spaced from the distal end portion of the device body18by a predetermined distance (at an approximately middle portion (intermediate portion) in the housing26).

In this state, regarding the head30, the pair of head side arms138is engaged with the pair of fixing member side arms152of the fixing member38. Further, the advance spring34is compressed between the elliptical plate134of the head30and the middle disk150of the fixing member38. Further, as for the guiding member40, the guiding member side hooks176(seeFIG. 10A) are engaged with the fixing member side hooks162(seeFIG. 9C) of the fixing member38and hand toward the distal end side.

Further, in the first state, as for the slider mechanism28attached to the distal end portion of the sensor inserting device10, the slider side connecting portion122of the slider98is positioned close to the rear wall108of the slider mechanism body96, and the slider controlling plate128of the slider98is engaged with the slider engaging portion116, so that the slider spring100is in a compressed state (seeFIG. 19A). Further, the dwelling member24is supported by the ribs132of the slider98so that the dwelling member24is arranged above the dwelling member window104. The transmitter16is located adjacent to the dwelling member24(the transmitter arrangement portion120), and the side surface and a portion of the front surface of the transmitter16are surrounded by the support arm124of the slider98.

Further, the sensor unit50and the insertion needle32are positioned, above the dwelling member24, where the distal end portion of the head30is attached. In this state, the sensor side hook64(also seeFIG. 5) of the sensor12and the engaging arm side hook216of the dwelling member24face each other. Further, as for the sensor unit50, the sensor side guiding portion62is temporarily engaged with the temporary-engaging protrusion174aof the guiding member40so that careless dropping of the sensor unit50toward the distal end side is prevented. From the first state, the inserting operation of the sensor unit50and the insertion needle32by the sensor inserting device10is carried out.

FIGS. 16 and 17illustrate a second state in which the sensor unit50and the insertion needle32are inserted in the skin S of a patient.

When the inserting operation of the sensor unit50and the insertion needle32is carried out, the user of the sensor inserting device10grips the push handle22with one hand and pushes the push handle22toward the distal end direction (Z1direction). In this manner, the first stage displacement of the operating bar180of the push handle22, in which the operating bar180goes over the first tooth88aof the housing26, is carried out. When the first stage displacement of the push handle22is carried out, the operating bar180is guided by the first tooth88ato deflect inward so as to move the contact portion186binward, thereby pushing the head side hook146of the head side arm138inward. As a result, the engagement of the head side arm138and the fixing member side arm152is released.

By the releasing of the engagement, the compressed advance spring34expands so as to strongly push out the head30toward the distal end direction. In this manner, the sensor12(sensor unit50) and the insertion needle32attached to the distal end portion of the head30move toward the distal end direction with the head30and the sensor unit50and the insertion needle32are inserted in the skin S of the patient facing the distal end portion of the sensor inserting device10. During the movement of the head30, the sensor unit50and the insertion needle32are guided by the arm groove174of the first guide arm166. Further, the head30can be moved toward the distal end direction without tilting the sensor unit50and the insertion needle32since the extending portion82guides the head side guide136and also the first and second guide arms166and168guide the first and second head side inserting holes142aand142b. During the movement of the head30, swingably engaging plate172of the first guide arm166swings toward the closing direction (direction toward the first guide arm166) by contacting the first head side inserting hole142aso as to allow the head30to pass.

By virtue of the inserting operation described above, the state of the sensor inserting device10changes to the second state in which the detector14of the sensor12is inserted into the body of the patient at the location of insertion, that is, the distal end of the device. In the second state, when the sensor unit50and the engaging arm44are viewed from the side surface direction (seeFIG. 17), the sensor side hook64is engaged with the engaging arm side hook216. That is, by the moving force toward the distal end direction of the sensor unit50, the engaging arm side hook216of the engaging arm44which is in the upright position enters into the sensor side hook64. As a result, the engaging arm44supports the sensor unit50at the location of insertion (i.e., the engaging arm44holds the sensor unit50at the insertion position).

Further, in the second state, the return spring36arranged on the distal end side of the head30is compressed by the movement of the head30toward the distal end direction. By compression of the return spring36, the moving force of the head30toward the distal end direction is absorbed, so that a suitable force for the insertion needle32to pierce the skin S of the patient is provided.

FIG. 18illustrates a third state in which the insertion needle32is separated from the sensor12.

After changing to the second state, the state of the sensor inserting device10changes to the third state as illustrated inFIG. 18. That is, in the sensor inserting device10, the return spring36compressed in the second state then expands to move the head30, which has moved toward the distal end direction, toward the proximal end direction. In the process, the insertion needle32is pulled back toward the proximal end direction along with the movement of the head30. However, the sensor unit50which has been temporarily held by the insertion needle32is kept in a state supported by the dwelling member24(a state in which the sensor side hook64is engaged with the engaging arm side hook216).

Therefore, in the third state, the sensor unit50continues to dwell at the location of insertion and the insertion needle32is separated from the sensor unit50. In this case, the sensor unit50is supported in the dwelling member24in the upright position by the engaging arm44.

Further, when the head30moves toward the proximal end direction, the swingably engaging plate172of the guiding member40makes contact with the head side guide136so that the moving force toward the proximal end direction is transmit from the head30to the guiding member40, thereby moving the guiding member40toward the proximal end direction with the head30. Therefore, in the third state, the guiding member40is separated from the slider mechanism28in the sensor inserting device10.

FIG. 19Aillustrates a state before the sliding operation of the transmitter16,FIG. 19Billustrates a fourth state after the sliding operation of the transmitter16, andFIG. 19Cillustrates a state in which the sensor inserting device10is separated from the skin of the patient.

After the third state, the state of the sensor inserting device10changes, by slidably moving the transmitter16, to the fourth state in which the sensor unit50and the transmitter16are connected. Note that, in the sensor inserting device10, the device body18and the dwelling member24are connected via the rib132so that the sensor inserting device10cannot be separated from the skin S until the supporting of the dwelling member24by the rib132is cancelled. Therefore, detachment of the sensor inserting device10in a state without connection to the transmitter16can be prevented. The supporting of the dwelling member24by the rib132can be cancelled by the sliding movement of the transmitter16.

In this case, the push handle22gripped by the user is further operated to push toward the distal end direction (Z1direction). In this manner, the second stage displacement of the operating bar180of the push handle22, in which the operating bar180goes over the second tooth88bof the housing26, is carried out. During the second stage displacement of the push handle22, the operating bar180is guided by the second tooth88bso as to deflect inward. Since the contact portion186bis formed to be offset from the arrangement of the fixing member side arm152of the fixing member38, the operating bar180can deflect without touching the fixing member side arm152, thereby allowing the push handle22to displace easily.

As illustrated inFIG. 19A, in the sensor inserting device10, in the first to third states, the push handle side pressing plate184of the push handle22is located above the slider controlling plate128of the slider mechanism28. In this state, when the second stage displacement of the push handle22is carried out, as illustrated inFIG. 19B, the push handle side pressing plate184formed in the lower portion of the push handle22can push in the slider controlling plate128. Then, the engagement of the slider controlling plate128of the slider98and the slider engaging portion116of the slider mechanism body96is released, and thereby the slider98slidably moves toward the rear direction by the pressing force of the slider spring100.

Along with the sliding movement of the slider98, the transmitter16supported by the support arm124(slider side hook130) moves toward the rear direction. Thereby, the transmitter16is inserted in the base42from the front side and moves, guided by the supporting groove200, until contact with the rear wall108is made.

By the movement of the transmitter16, the sensor unit50and the engaging arm44which have been in the upright position at an approximately middle location of the base42contacts the transmitter16and are pressed to fall down. That is, the engaging arm44rotates about the bearing214and falls down rearward by contacting the transmitter16. The sensor unit50also falls down rearward by contacting the transmitter16, bending the connecting portion56aof the sensor base56. In this process, the engaging arm44falls down into the containing hole198so as to be contained in the containing hole198. The engaging plate thus moves from the vertically oriented upstanding position to the horizontally oriented fall down position.

Further, the sensor unit50which is made to fall down by the transmitter16enters into the connecting terminal recess222along with the sliding movement of the transmitter16. That is, the sensor12and the engaging member52are contained in the first space222a, and the connecting member54is contained in the second space222b. In this state, since the second space222bis formed in a tapered shape, the connecting member54can easily be introduced into the second space222b. Further, in a state when the transmitter16is inserted in the base42, the tapered surface (conductive terminal) of the connecting member54is connected to the tapered surface224(conductive connecting surface) inside the second space222bso that the blood sugar level (current value) detected by the sensor12can surely be transmitted to the transmitter16.

Further, in a state when the transmitter16is inserted in the base42, the rib132which has supported the dwelling member24is separated from the guiding groove202, thereby cancelling the supporting state. Therefore, as illustrated inFIG. 19C, the dwelling member24(including the sensor unit50and the transmitter16) can be taken out from or can pass through the dwelling member window104of the slider mechanism body96. In this manner, the sensor inserting device10allows the sensor unit50and the transmitter16to dwell on the skin S of the patient while the remainder of the sensor inserting device10is separated from the sensor unit50and the transmitter16.

As described above, the sensor inserting device10according to the embodiment disclosed here by way of example provides the insertion of the detector14of the sensor12into the body of the patient by the movement mechanism20and the connection between the sensor12and the transmitter16at the location of insertion, and allows the sensor12and the transmitter16to dwell on the skin S of the patient. Consequently, the connection between the sensor unit50and the transmitter16which are to dwell on the skin S of the patient need not be carried out manually, so that the insertion and dwelling of the sensor12can be carried out within a shorter time, thereby reducing suffering of the patient.

Further, since the dwelling member24is attached to the sensor12by the movement of the sensor unit50caused by the movement mechanism20, the sensor12can be attached to the dwelling member24without effort. The sensor inserting device10thus provides further efficient operation of the insertion and dwelling of the sensor12.

Further, by the dwelling member24supporting (engaging) the sensor unit50by the engaging arm44and the base42supporting the sensor unit50in a state connected to the transmitter16, further firm connection of the sensor unit50and the transmitter16on the skin S of the patient is provided, thereby providing stable and continuous detection of biological information by the sensor12.

In this case, by the slider mechanism28allowing the transmitter16to slide toward the base42so that the transmitter16is inserted, and supported by the dwelling member24, the connection between the sensor unit50and the transmitter16is rather easily carried out.

Further, by a relatively simple operation of the two-stage displacement of the push handle22toward the distal end direction of the device body18, the sensor inserting device10inserts the detector14of the sensor12into the body of the patient and further allows the sensor base56of the sensor12and the transmitter16to be connected with each other and dwell on the skin S of the patient.

The above description of the operation of the sensor inserting device10describes the two-stage displacement of the push handle22in a stagewise manner. However, the user can carry out the displacement of the push handle22continuously without stopping the operation between the first stage and the second stage. That is, the user can change the state of the sensor inserting device10from the first stage through the fourth stage by a single-push operation of the push handle22.

Further, by including the safety mechanism226, the sensor inserting device10can rather surely prevent trouble of carelessly moving the sensor unit50and the insertion needle32toward the distal end direction and piercing with the insertion needle32.

The detailed description above describes a sensor inserting device disclosed by way of example. The invention is not limited, however, to the precise embodiment and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.