Patent Description:
Conventionally, a medical device such as a tubular member, a sensor, and the like may be implanted in a living body of a subject such as a patient. For example, a sensor is implanted in a living body of the subject and detection of analytes (for example, glucose, pH, cholesterol, protein, and the like) in blood or in a body fluid of the subject is performed. In this case, an insertion device is used to quickly and easily implant a sensor in the living body through the skin of the subject (see Patent Literature <NUM> and <NUM>). The insertion devices described in Patent Literature <NUM> and <NUM> are configured to insert the sensor into the living body together with a needle portion, indwell the sensor, and then remove only the needle portion from the living body.

When a gap between the needle portion and a medical device accommodated in the needle portion is small, the medical device is likely to be caught by an inner surface of the needle portion when removing the needle portion from the living body with the medical device remaining in the living body. Therefore, an insertion position of the medical device may be shallower than the desired depth in the living body. When the gap between the needle portion and the medical device accommodated in the needle portion is large, the medical device is likely to move in the needle portion due to an impact or the like when the medical device and the needle portion are inserted into the living body together. Therefore, the medical device may not be inserted at the desired depth in the living body.

The present disclosure is intended to provide an insertion device and a needle member, not claimed as such but useful for understanding the invention, provided with a needle portion configured to easily achieve implantation of a medical device at a desired depth in a living body.

An insertion device according to a first aspect of the present disclosure is an insertion device for inserting a medical device into a living body, includes: a needle portion internally defining an accommodation space for accommodating the medical device and configured to be inserted into a living body together with the medical device to be accommodated in the accommodation space; and a movable portion relatively movable with respect to the needle portion in the accommodation space in a direction of insertion of the needle portion, wherein the needle portion includes a clamping portion capable of changing a form in the accommodation space between a first form of clamping the medical device accommodated in the accommodation space and a second form of not clamping the medical device accommodated in the accommodation space, and the movable portion engages the clamping portion by moving in the direction of insertion with respect to the needle portion to change the form of the clamping portion from the first form to the second form.

As one embodiment of the present disclosure, the needle portion includes a sidewall portion that defines the accommodation space and a projection portion projecting from the sidewall portion toward the accommodation space, and the clamping portion includes an inner surface of the sidewall portion and the projection portion, the movable portion engages the projecting portion by moving in the direction of insertion with respect to the needle portion and deforming the projection portion to change the form of the clamping portion from the first form to the second form.

As one embodiment of the present disclosure, the movable portion defines a groove space extending along the direction of insertion that is located within the accommodation space and can accommodate the medical device.

The insertion device as one embodiment of the present disclosure includes a restricting mechanism configured to restrict relative movement of the needle portion and the movable portion in directions other than a longitudinal direction of the needle portion.

A needle member as a second aspect of the present disclosure , not claimed as such but useful for understanding the invention, is a needle member internally defining an accommodation space that can accommodate the medical device and includes a needle portion configured to be inserted into a living body together with a medical device to be accommodated in the accommodation space. The needle portion includes a clamping portion located in the accommodation space and capable of changing a form between a first form of clamping the medical device accommodated in the accommodation space and a second form of not clamping the medical device accommodated in the accommodation space.

According to the present disclosure, an insertion device and a needle member (not part of the invention) including a needle portion configured to easily achieve implantation of a medical device at the desired depth in a living body is provided.

Referring now to the drawings, embodiments of an insertion device and a needle member, not claimed as such but useful for understanding the invention, according to the present disclosure will be described. The same reference numerals are given to common parts and portions in the drawings.

<FIG> illustrate an insertion device <NUM> according to a first embodiment of the present disclosure. In addition, as will be described in detail below, <FIG> each illustrate an overview of an operation of the insertion device <NUM> when inserting and implanting a sensor <NUM> in a living body using the insertion device <NUM>. The insertion device <NUM> illustrated in <FIG> can insert the sensor <NUM> as the medical device into the living body. Hereinafter, in the present embodiment, the insertion device <NUM> configured to insert the sensor <NUM> into the living body will be described. However, the medical device to be inserted into the living body by the insertion device <NUM> is not limited to the sensor <NUM>. Therefore, the insertion device may be configured to insert a tubular member other than the sensor, such as a cannula.

As illustrated in <FIG>, the insertion device <NUM> includes a needle member <NUM>, a movable member <NUM>, a housing <NUM>, a biasing member <NUM>, a controller <NUM>, and the sensor <NUM>. As will be described in detail below, the needle member <NUM> of the present embodiment includes a needle portion <NUM>. Also, as will be described in detail below, the movable member <NUM> of the present embodiment includes a movable portion <NUM>.

Referring now to <FIG>, a method of using the insertion device <NUM> of the present embodiment will be described. The insertion device <NUM> of the present embodiment may be used for inserting and implanting the sensor <NUM> in the living body as described above. The insertion device <NUM> is disposed on a living body surface BS in a state illustrated in <FIG>. In other words, <FIG> illustrates a state before the needle portion <NUM> of the needle member <NUM> and the sensor <NUM> are inserted into a living body. Then, an operator such as a health care worker operates the insertion device <NUM> to insert the needle portion <NUM> of the needle member <NUM> and the sensor <NUM> into the living body (See <FIG> and <FIG>). <FIG> is a drawing illustrating a state in the course of inserting the needle portion <NUM> and the sensor <NUM> into the living body by the insertion device <NUM>. <FIG> is a drawing illustrating a state in which the needle portion <NUM> and the sensor <NUM> reach the deepest possible position in the living body, where the insertion device <NUM> can be inserted. Next, as illustrated in <FIG>, the needle portion <NUM> of the needle member <NUM> is removed to outside of the living body with the sensor <NUM> left in the living body. In this manner, the sensor <NUM> can be inserted and implanted into the living body by the insertion device <NUM>. For the sake of convenience of explanation, the position of the needle portion <NUM> in <FIG> where the needle portion <NUM> is accommodated in the housing <NUM> may be referred to as "a (the) waiting position of the needle portion <NUM>", hereinafter. Likewise, for the sake of convenience of explanation, the position of the needle portion <NUM> in <FIG> where the needle portion <NUM> protrudes the most from the housing <NUM> is referred to as "a (the) insertion position of the needle portion <NUM>" hereinafter.

The sensor <NUM> to be implanted in the living body detects a substance to be measured (analyte) and transmits information of a detection result to the controller <NUM>. The controller <NUM> is connected to the sensor <NUM> and is implanted on the living body surface BS together with the sensor <NUM>. The controller <NUM> includes a processor, a memory, a battery, a communication unit and the like. The sensor <NUM> of the present embodiment illustrated in <FIG> transmits the information of the detection result to the controller <NUM>. By using the sensor <NUM> together with the controller <NUM>, a signal can be detected according to the concentration of the substance to be measured. The detected signal is processed by the controller <NUM> and is transmitted to a smartphone or a dedicated terminal of a subject. The subject or the user can confirm the result of measurement of the substance to be measured displayed on a screen of the smartphone or the dedicated terminal with time. A time period during which the sensor <NUM> is attached to the subject is determined as appropriate in the determination of the doctor or the like, such as several hours, several days, a week, a month, and so forth. Although the substance to be measured is not particularly limited, for example, glucose, oxygen, pH, lactic acid, or the like in the blood or an interstitial fluid can be measured according to the selection of the detection portion of the sensor <NUM>. Note that the controller <NUM> may be connected to a separately provided transmitter (not illustrated) after the completion of insertion of the sensor <NUM>. In this case, instead of the controller <NUM>, the transmitter may be configured to have a memory, a battery, and the like. The transmitter may be configured to be used for a longer period than the sensor <NUM>.

The details of each member and each portion of the insertion device <NUM> will be described below.

<FIG> and <FIG> are perspective views illustrating the needle portion <NUM> of the needle member <NUM>, the movable portion <NUM> of the movable member <NUM>, and the sensor <NUM> in the insertion device <NUM> in the state illustrated in <FIG>. <FIG> and <FIG> are perspective views viewed from different viewpoints. <FIG> is an enlarged perspective view illustrating a vicinity of a distal end portion of the needle portion <NUM> in <FIG> in an enlarged scale. <FIG> is an enlarged perspective view illustrating the vicinity of the distal end portion of the needle portion <NUM> in <FIG> in an enlarged scale.

Hereinafter, in this specification, an end of the needle portion <NUM> of the needle member <NUM> to be inserted into the living body will be referred to as "a (the) distal end of the needle portion <NUM>. " Also, an opposite end from the distal end of the needle portion <NUM> of the needle member <NUM> is referred to as "a (the) proximal end of the needle portion <NUM>. " Further, a direction from the proximal end toward the distal end of a longitudinal direction A of the needle portion <NUM> of the needle member <NUM> is referred to as "direction of insertion A1" or "distal side. " Further, a direction from the distal end toward the proximal end of the longitudinal direction A of the needle portion <NUM> of the needle member <NUM> is referred to as "direction of removal A2" or "proximal side. " A radial direction B of the needle portion <NUM> refers to a radial direction of a circle, which is defined on a plane orthogonal to the longitudinal direction A of the needle portion <NUM> around the needle portion <NUM> with a center at the needle portion <NUM>. An outward direction from a central axis of the needle portion <NUM> of the needle member <NUM> is referred to as "outward in the radial direction B. " A direction toward the central axis of the needle portion <NUM> from a circumference of the circle, which is defined around the needle portion <NUM> of the needle member <NUM>, is referred to as "inside in the radial direction B. " The center of the circle is an equal distance from one end portion (connection with the first side plate portion 15a) and the other end (connection with the second side plate portion 15b) of the third side plate portion 15c described below in the cross section in the short axis direction of the needle portion <NUM>.

As illustrated in <FIG>, the needle member <NUM> includes the needle portion <NUM> and a holding portion <NUM>.

As illustrated in <FIG>, the needle portion <NUM> internally includes an accommodation space <NUM> that can accommodate the sensor <NUM>. The needle portion <NUM> is inserted into the living body together with the sensor <NUM> to be accommodated in the accommodation space <NUM>.

As illustrated in <FIG>, <FIG>, <FIG>, and <FIG>, the needle portion <NUM> includes a clamping portion <NUM> capable of clamping the sensor <NUM> accommodated in the accommodation space <NUM>. A form of the clamping portion <NUM> in the accommodation space <NUM> changes between a first form of clamping the sensor <NUM> accommodated in the accommodation space <NUM> and a second form of not clamping the sensor <NUM> accommodated in the accommodation space <NUM>. A form of the clamping portion <NUM> changes from the first form to the second form by engaging the movable portion <NUM>, described below. In this manner, the needle portion <NUM> configured to achieve implantation of the sensor <NUM> at the desired depth easily in the living body is realized. Details of the change of the form of the clamping portion <NUM> of the present embodiment will be described below (see <FIG>).

As illustrated in <FIG>, <FIG>, <FIG>, and <FIG>, the needle portion <NUM> of the present embodiment is provided with a gap <NUM> formed to extend in a longitudinal direction A. The gap <NUM> may be formed over an entire area of the needle portion <NUM> in the longitudinal direction A as in the present embodiment. Alternatively, the gap <NUM> may be formed only in part of the needle portion <NUM> in the longitudinal direction A. However, when the gap <NUM> is formed only in part of the needle portion <NUM> in the longitudinal direction A, the gap <NUM> extends at least from the middle of the needle portion <NUM> in the longitudinal direction A to a distal end of the needle portion <NUM>. In other words, the gap <NUM> is opened to outside at the distal end of the needle portion <NUM>. The length of the gap <NUM> in the longitudinal direction A is not specifically limited. The length may be designed as needed according to the length of the sensor <NUM>, described below, or the like.

As illustrated in <FIG>, <FIG>, <FIG>, and <FIG>, the needle portion <NUM> of the present embodiment includes a sidewall portion <NUM> that defines the accommodation space <NUM> and a projection portion <NUM> projecting from the sidewall portion <NUM> toward the accommodation space <NUM>.

The sidewall portion <NUM> of the present embodiment includes the first side plate portion 15a and the second side plate portion 15b arranged to face each other, and the third side plate portion 15c continuing to the respective end portions of the first side plate portion 15a and the second side plate portion 15b on one side. The first side plate portion 15a, the second side plate portion 15b, and the third side plate portion 15c define the accommodation space <NUM>. The gap <NUM> described above is formed at a position opposing the third side plate portion 15c with the accommodation space <NUM> interposed therebetween. That is, a space interposed between the first side plate portion 15a and the second side plate portion 15b on an upper side of the third side plate portion 15c of the needle portion <NUM> corresponds to the accommodation space <NUM>.

The sidewall portion <NUM> extends in the longitudinal direction A. More specifically, the first side plate portion 15a, the second side plate portion 15b, and the third side plate portion 15c of the present embodiment are each made of an elongated flat plate portion extending in the longitudinal direction A. That is, the sidewall portion <NUM> of the present embodiment monolithically defines a rectangular-shaped groove with three flat-plate shaped portions; the first side plate portion 15a, the second side plate portion 15b, and the third side plate portion 15c. However, the cross-sectional profile orthogonal to the longitudinal direction A of the sidewall portion <NUM> is not limited to the shape of the rectangular-shaped groove as in the present embodiment. Rather, the sidewall portion <NUM> may have other corss-sectional profiles, such as a U-shape, C-shape, and the like. In that case, the first side plate portion 15a and the second side plate portion 15b have a flat-plate shape, and the third side plate portion 15c is a half-tubular member having a cross-sectional shape of a semicircular shape or a substantially half semicircular arc. In this manner, the needle portion <NUM> has the gap <NUM> at a position opposing the third side plate portion 15c, and the gap <NUM> extends in the longitudinal direction A of the needle portion <NUM>. Because the sensor <NUM> of the present embodiment is connected to the controller <NUM> via a wire, the sidewall portion <NUM> is configured to have the gap <NUM>. In the case of the sensor or the like connected to the controller <NUM> wirelessly, a tubular sidewall portion having no gap <NUM> is also applicable.

However, as will be described in detail below, when a flap <NUM> is formed by using part of the sidewall portion <NUM> and the flap <NUM> is utilized as the projection portion <NUM> (see <FIG>, etc.), it is preferable to provide a flat-plate shaped portion on at least a portion of the sidewall portion <NUM> provided with the flap <NUM>. In this configuration, the resiliently deforming performance of the flap <NUM> as the projection portion <NUM> may be enhanced.

As illustrated in <FIG>, <FIG>, <FIG>, and <FIG>, a cutting edge is formed at a distal end of the sidewall portion <NUM>. In the sidewall portion <NUM> of the present embodiment, the third side plate portion 15c extends further in a direction of insertion A1 than does a distal end portion of the first side plate portion 15a and the second side plate portion 15b. In the sidewall portion <NUM> of the present embodiment, the cutting edge is formed only at a distal end of the third side plate portion 15c. More specifically, the distal end portion of the flat-plate shaped third side plate portion 15c of the present embodiment is provided with a tapered portion on both sides in a width direction so as to be tapered toward the distal end. Accordingly, the distal end of the third side plate portion 15c is sharpened to form the cutting edge of the sidewall portion <NUM>. At the distal end portion of the third side plate portion 15c, distal end surfaces of the first side plate portion 15a and the second side plate portion 15b in the direction of insertion A1 are inclined with respect to the longitudinal direction A so that end surfaces of the first side plate portion 15a and the second side plate portion 15b along the gap <NUM> get closer to the third side plate portion 15c as it proceeds in the direction of insertion A1. In the present embodiment, although the distal end of the third side plate portion 15c is sharpened to form the cutting edge of the sidewall portion <NUM>, the configuration is not limited thereto. For example, the sidewall portion may have such configuration that the distal end surface includes one or more cutting surfaces that incline with respect to the longitudinal direction A.

In the present embodiment, facing widths of outer surfaces of the first side plate portion 15a and the second side plate portion 15b of the sidewall portion <NUM> may be, for example, <NUM> to <NUM>. A length of the sidewall portion <NUM> to be inserted into the living body may be, for example, <NUM> to <NUM>, preferably <NUM> to <NUM>. A thickness of the first side plate portion 15a, the second side plate portion 15b, and the third side plate portion 15c may be set from a range, for example, from <NUM> to <NUM>.

As illustrated in <FIG>, <FIG>, <FIG>, and <FIG>, the projection portion <NUM> projects from the sidewall portion <NUM> toward the accommodation space <NUM> as described above. The projection portion <NUM> of the present embodiment projects from the first side plate portion 15a of the sidewall portion <NUM> toward the accommodation space <NUM>. However, the projection portion <NUM> may project from the second side plate portion 15b or the third side plate portion 15c toward the accommodation space <NUM>.

Also, as illustrated in <FIG>, <FIG>, <FIG>, and <FIG>, the projection portion <NUM> of the present embodiment is formed of the flap <NUM> formed on part of the sidewall portion <NUM>. When the flap <NUM> as the projecting portion <NUM> of the present embodiment is pushed toward the accommodation space <NUM>, a distal side of the flap projects toward the accommodation space <NUM>. More specifically, the flap <NUM> as the projection portion <NUM> of the present embodiment is formed by forming a slit in the first side plate portion 15a and pushing toward the accommodation space <NUM>. In this manner, the projection portion <NUM> is achieved with a simple configuration.

The flap <NUM> as the projection portion <NUM> of the present embodiment includes a first outer edge portion 41a, a second outer edge portion 41b, and a third outer edge portion 41c. The first outer edge portion 41a extends linearly in a direction orthogonal to the longitudinal direction A in the first side plate portion 15a. The second outer edge portion 41b extends linearly or in a curved manner from one end of the first outer edge portion 41a (the gap <NUM> side of the needle portion <NUM> in the present embodiment) to one end side of the longitudinal direction A (a direction of removal A2 in the present embodiment). The third outer edge portion 41c extends linearly or in a curved manner from the other end of the first outer edge portion 41a (the third side plate portion 15c side in the present embodiment) to one end side of the longitudinal direction A (the direction of removal A2 in the present embodiment). The flap <NUM> as the projection portion <NUM> of the present embodiment is formed by the first outer edge portion 41a, the second outer edge portion 41b, and the third outer edge portion 41c. In other words, the flap <NUM> of the present embodiment has an end portion in the direction of removal A2 continuing to the first side plate portion 15a of the sidewall portion <NUM>. The flap <NUM> of the present embodiment is pushed at the end portion side in the direction of insertion A1 toward the accommodation space <NUM> with an end portion in the direction of removal A2, which continues to the first side plate portion 15a, as a fulcrum. Specifically, the flap <NUM> of the present embodiment includes an inclined portion <NUM> inclining with respect to the longitudinal direction A away from the first side plate portion 15a toward the interior of the accommodation space <NUM> as it goes from the end portion continuing to the first side plate portion 15a in the direction of removal A2 toward a free end in the direction of insertion A1. In other words, the inclined portion <NUM> inclines from the first side plate portion 15a in a direction toward the second side plate portion 15b as it goes to the free end in the direction of insertion A1. In addition, the flap <NUM> of the present embodiment includes, in addition to the inclined portion <NUM> described above, a flap distal end portion <NUM> continuing to the inclined portion <NUM>. The flap distal end portion <NUM> of the present embodiment has a smaller angle of inclination with respect to the longitudinal direction A than the inclined portion <NUM>. The flap distal end portion <NUM> of the present embodiment extends substantially parallel to the longitudinal direction A.

As described above, all of the first outer edge portion 41a, the second outer edge portion 41b, and the third outer edge portion 41c extend linearly. In other words, the flap <NUM> as the projection portion <NUM> of the present embodiment has a substantially rectangular profile. However, the shape of the flap <NUM> as the projection portion <NUM> is not specifically limited. The flap <NUM> may have other profiles such as a U-shape, a C-shape, and a triangular shape.

Although the flap <NUM> as the projection portion <NUM> of the present embodiment includes the end portion in the direction of removal A2 continuing to the sidewall portion <NUM>, the position of continuing to the sidewall portion <NUM> is not specifically limited. Therefore, the flap <NUM> may have the end portion in the direction of insertion A1 continuing to the sidewall portion <NUM>. The flap <NUM> may be such that any of the end portions in the direction orthogonal to the longitudinal direction A continues to the sidewall portion <NUM>. As will be described in detail below, the flap <NUM> as the projection portion <NUM> of the present embodiment clamps the sensor <NUM> between the flap <NUM> and an inner surface of the sidewall portion <NUM>. Further, the flap <NUM> of the present embodiment is deformed by engaging the movable portion <NUM> that moves in the direction of insertion A1 within the accommodation space <NUM> to release the clamped state of the sensor <NUM>. For these reasons, the flap <NUM> as the projection portion <NUM> is preferably configured to have the end portion in the direction of removal A2 continuing to the sidewall portion <NUM> as in the present embodiment. With the flap <NUM> configured in this manner, both of clamping of the sensor <NUM> described above and deformation by the engagement with the movable portion <NUM> moving in the direction of insertion A1 can easily be achieved with a simple form.

The clamping portion <NUM> of the needle portion <NUM> of the present embodiment includes the inner surface of the sidewall portion <NUM> and the projection portion <NUM>. That is, the needle portion <NUM> of the insertion device <NUM> of the present embodiment clamps the sensor <NUM> to be accommodated in the accommodation space <NUM> between the inner surface of the sidewall portion <NUM> and the projection portion <NUM>. More specifically, the needle portion <NUM> of the insertion device <NUM> of the present embodiment clamps the sensor <NUM> to be accommodated in the accommodation space <NUM> between the inner surface of the second side plate portion 15b of the sidewall portion <NUM> on the accommodation space <NUM> side and the flap distal end portion <NUM> of the flap <NUM> as the projection portion <NUM>. The movable portion <NUM> of the movable member <NUM> described below moves in the accommodation space <NUM> in the direction of insertion A1 to engage the inclined portion <NUM> of the flap <NUM> as the projection portion <NUM>. More in detail, the distal end of the movable portion <NUM> comes into contact with the flap <NUM> as the projection portion <NUM>, and the movable portion <NUM> moves further in the direction of insertion A1, whereby the distal end portion of the movable portion <NUM> pushes the flap <NUM> away. Accordingly, the flap <NUM> as the projection portion <NUM> is resiliently deformed toward the first side plate portion 15a and is retracted from the interior of the accommodation space <NUM>. In other words, the flap <NUM> as the projection portion <NUM> retracts away from the inner surface of the second side plate portion 15b of the sidewall portion <NUM> that clamps the sensor <NUM> together. Therefore, the clamped state of the sensor <NUM> between the inner surface of the second side plate portion 15b of the sidewall portion <NUM> and the flap <NUM> as the projection portion <NUM> is released. Consequently, the sensor <NUM> is brought into a state of movable in the longitudinal direction A with respect to the needle portion <NUM>. This will be described in detail below (See <FIG>).

<FIG> is a cross-sectional view taken along a section along the line I-I in <FIG>. As illustrated in <FIG>, the inner surface of the needle portion <NUM> of the present embodiment includes a rib <NUM> projecting toward the accommodation space <NUM>. More specifically, the rib <NUM> protruding toward the accommodation space <NUM> and extending in the longitudinal direction A is formed on the inner surface of the third side plate portion 15c of the sidewall portion <NUM> of the needle portion <NUM> of the present embodiment. The rib <NUM> fits a receiving groove <NUM> of the movable portion <NUM> of the movable member <NUM>, described below, and constitutes part of a restricting mechanism <NUM> together with the receiving groove <NUM>. The rib <NUM> may simply be provided at least part of the needle portion <NUM> in the longitudinal direction A. The restricting mechanism <NUM> means a mechanism for restricting relative movement between the needle portion <NUM> and the movable portion <NUM> in the directions other than the longitudinal direction A.

A metal material suitable for plastic working is used as the material of the needle portion <NUM>. Examples of the materials that can be used include a metallic material such as stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, and magnesium alloy.

The holding portion <NUM> holds the proximal end portion of the needle portion <NUM>. The holding portion <NUM> of the present embodiment includes a main body portion <NUM> and a locking claw portion <NUM>. The main body portion <NUM> is provided with a holding opening 51a penetrating in the longitudinal direction A. The proximal end portion of the needle portion <NUM> is fixed to the main body portion <NUM> in a state of being inserted in the holding opening 51a. The locking claw portion <NUM> projects from the main body portion <NUM> toward the direction of removal A2. The locking claw portion <NUM> is positioned outside the needle portion <NUM> in the radial direction B of the needle portion <NUM>. Also, the needle member <NUM> of the present embodiment is provided with a plurality of the locking claw portions <NUM> so as to surround the periphery of the needle portion <NUM> outside the needle portion <NUM> in the radial direction B. The locking claw portions <NUM> each include an extending portion <NUM> protruding from the main body portion <NUM> and an engagement projection <NUM> provided at an end portion of the extending portion <NUM> in the direction of removal A2. The extending portion <NUM> is resiliently deformable in a direction orthogonal to the longitudinal direction A with the position continuing to the main body portion <NUM> as a fulcrum. More specifically, the extending portion <NUM> of the present embodiment is resiliently deformable in the radial direction B of the needle portion <NUM> with the position continuing to the main body portion <NUM> as a fulcrum. The engagement projection <NUM> protrudes in the direction orthogonal to the longitudinal direction A from the end portion of the extending portion <NUM>. An upper surface 54a located in the direction of removal A2 of each engagement projection <NUM> is inclined with respect to the longitudinal direction A so as to extend inward in the radial direction B as it proceeds the direction of insertion A1. The upper surfaces 54a of the engagement projections <NUM> are pressed outward in the radial direction B by being engaged with the main body portion <NUM>, described below, of the movable member <NUM>. A detailed description of this configuration will be given below.

Examples of the material of the holding portion <NUM> include a resin material. Examples of the resin material include: thermoplastic resins used in injection molding such as ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluorine resin, polycarbonate, polyamide, acetal resin, acrylic resin, and polyethylene terephthalate; and thermosetting resins such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester.

The movable member <NUM> includes the movable portion <NUM> and a main body portion <NUM>.

The movable portion <NUM> is movable with respect to the needle portion <NUM> in the accommodation space <NUM> in the direction of insertion A1 of the needle portion <NUM>. The movable portion <NUM> engages the clamping portion <NUM> of the needle portion <NUM> by moving in the direction of insertion A1 with respect to the needle portion <NUM>. Accordingly, the movable portion <NUM> changes the form of the clamping portion <NUM> of the needle portion <NUM> from the first form to the second form. More specifically, the movable portion <NUM> of the present embodiment moves in the direction of insertion A1 with respect to the needle portion <NUM> to engage the projection portion <NUM> of the clamping portion <NUM> of the needle portion <NUM>. Accordingly, the movable portion <NUM> of the present embodiment deforms the projection portion <NUM> and changes the form of the clamping portion <NUM> of the needle portion <NUM> from the first form to the second form. As described above, the first form of the clamping portion <NUM> means a form of clamping the sensor <NUM> accommodated in the accommodation space <NUM>. Also, as described above, the second form of the clamping portion <NUM> means a form of not clamping the sensor <NUM> accommodated in the accommodation space <NUM>.

As illustrated in <FIG>, <FIG>, <FIG>, and <FIG>, the movable portion <NUM> of the present embodiment includes a rod portion extending in the accommodation space <NUM> along the longitudinal direction A of the needle portion <NUM>. The rod portion as the movable portion <NUM> of the present embodiment has a depressed cross-sectional shape. Therefore, a groove space <NUM> extending along the longitudinal direction A and capable of accommodating the sensor <NUM> is defined in the movable portion <NUM> of the present embodiment. In other words, the movable portion <NUM> of the present embodiment includes a groove-shaped rod portion. An opening portion <NUM> where the groove space <NUM> extending along the longitudinal direction A is connected to the outside is formed over the entire movable portion <NUM> in the longitudinal direction A.

The groove-shaped rod portion as the movable portion <NUM> of the present embodiment includes a first groove wall portion 21a and a second groove wall portion 21b arranged to oppose each other, and a groove bottom portion 21c continuing to respective end portions of the first groove wall portion 21a and the second groove wall portion 21b on one side. The first groove wall portion 21a, the second groove wall portion 21b, and the groove bottom portion 21c define the groove space <NUM>. The opening portion <NUM> described above is formed at a position opposing the groove bottom portion 21c with the groove space <NUM> interposed therebetween.

The first groove wall portion 21a, the second groove wall portion 21b, and the groove bottom portion 21c of the present embodiment are each made of an elongated flat plate extending in the longitudinal direction A. That is, the groove-shaped rod portion as the movable portion <NUM> of the present embodiment forms a rectangular-shaped groove space <NUM> by three flat plate-shaped portions; the first groove wall portion 21a, the second groove wall portion 21b, and the groove bottom portion 21c. However, the cross-sectional profile orthogonal to the longitudinal direction A of the movable portion <NUM> is not limited to the shape of the rectangular-shaped groove as in the present embodiment. Rather, the movable portion <NUM> may be a movable portion having other cross-sectional profiles, such as a U-shape, C-shape, and the like.

In the groove-shaped rod portion as the movable portion <NUM> of the present embodiment, the first groove wall portion 21a extends longer in the direction of insertion A1 than the second groove wall portion 21b. In other words, the first groove wall portion 21a projects toward the direction of insertion A1 more than the second groove wall portion 21b. Also, although the groove bottom portion 21c of the present embodiment extends further in the direction of insertion A1 beyond the end portion of the first groove wall portion 21a in the direction of insertion A1, the position of the groove bottom portion 21c in the direction of insertion A1 is not specifically limited. Therefore, the position of the end portion of the groove bottom portion 21c in the direction of insertion A1 may be positioned in the direction of removal A2 than the first groove wall portion 21a. Also, the position of the end portion of the groove bottom portion 21c in the direction of insertion A1 may be positioned in the direction of removal A2 than the second groove wall portion 21b.

Although the opening portion <NUM> of the present embodiment is formed over the entirety of the movable portion <NUM> in a longitudinal direction A, it may be formed only part of the movable portion <NUM> in the longitudinal direction A. Conversely, the movable portion <NUM> may have a tubular portion partly in the longitudinal direction A. However, when the opening portion <NUM> is formed only partly in the longitudinal direction A, the opening portion <NUM> extends at least to the end surface of the movable portion <NUM> in the direction of insertion A1. In other words, the opening portion <NUM> is opened to the outside at least at the end surface of the movable portion <NUM> in the direction of insertion A1. The length of the opening portion <NUM> in the longitudinal direction A is not specifically limited. The length may be designed as needed according to the length of the sensor <NUM>, described below, or the like.

Also, the sensor <NUM> of the present embodiment is connected to the controller <NUM> via a cable. Therefore, the movable portion <NUM> includes the opening portion <NUM> extending at least to the end surface in the direction of insertion A1. However, for example, in the case of the sensor or the like connected wirelessly with the controller <NUM>, the opening portion <NUM> may have a tubular configuration having no opening portion <NUM> as a whole.

Further, as illustrated in <FIG>, the movable portion <NUM> of the present embodiment is provided with a receiving groove <NUM> extending in the longitudinal direction A formed on an outer surface thereof. More specifically, the receiving groove <NUM> extending in the longitudinal direction A is formed on the outer surface of the groove bottom portion 21c of the movable portion <NUM>. The movable portion <NUM> is disposed in the needle portion <NUM> with the rib <NUM> fitted to the receiving groove <NUM>. With the receiving groove <NUM> and the rib <NUM>, relative movement between the needle portion <NUM> and the movable portion <NUM> in the directions other than the longitudinal direction A may be restricted. In other words, in the present embodiment, the receiving groove <NUM> and the rib <NUM> constitute the restricting mechanism <NUM> configured to restrict the relative movement of the needle portion <NUM> and the movable portion <NUM> in directions other than the longitudinal direction A.

A metal material capable of plastic working is used as the material of the movable part <NUM>. Examples of the materials that can be used include a metallic material such as stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, and magnesium alloy.

The main body portion <NUM> holds the end portion of the movable portion <NUM> in the direction of removal A2. The main body portion <NUM> of the present embodiment is attached so as to be movable in the longitudinal direction A in the housing <NUM>. The main body portion <NUM> of the present embodiment has an upper surface in the direction of removal A2 exposed from the housing <NUM> to the outside. Therefore, the operator of the insertion device <NUM> can move the main body portion <NUM> in the direction of insertion A1 by pressing the main body portion <NUM> exposed from the housing <NUM> in the direction of insertion A1. Accordingly, the movable portion <NUM> attached to the main body portion <NUM> can also move in the accommodation space <NUM> of the needle portion <NUM> in the direction of insertion A1. In other words, the main body portion <NUM> also serves as an operation unit of the insertion device <NUM>.

The main body portion <NUM> includes an engagement portion <NUM> configured to press the locking claw portions <NUM> of the holding portion <NUM> of the needle member <NUM> outward in the radial direction B of the needle portion <NUM>. The main body portion <NUM> defines an engagement depression <NUM>, in which the engagement projection <NUM> of the locking claw portion <NUM> can fit, at a position adjacent to the engagement portion <NUM> in the direction of removal A2. The engagement depression <NUM> is depressed inward with respect to the engagement portion <NUM> in the radial direction B. As illustrated in <FIG>, the engagement portion <NUM> may be formed, for example, of a disk portion. Also, as illustrated in <FIG>, the engagement depression <NUM> is formed by an annular groove located adjacent to the disk portion as the engagement portion <NUM> in the direction of removal A2 and depressed inward with respect to an outer edge of the disk portion in the radial direction B. However, the configurations of the engagement portion <NUM> and the engagement depression <NUM> are not limited to the shape and the position illustrated in the present embodiment.

As illustrated in <FIG>, the insertion device <NUM> of the present embodiment can insert the needle portion <NUM> and the sensor <NUM> into the living body by pushing the main body portion <NUM> in the direction of insertion A1. At that time, the engagement portion <NUM> of the main body portion <NUM> engages the upper surfaces 54a located in the direction of removal A2 of the engagement projections <NUM> of the locking claw portions <NUM> and presses the engagement projections <NUM> outward in the radial direction B. Accordingly, as illustrated in <FIG>, the extending portions <NUM> of the locking claw portions <NUM> resiliently deform outward in the radial direction B. In other words, the plurality of locking claw portions <NUM> located in the outside periphery of the needle portion <NUM> in the radial direction B resiliently deform outward in the radial direction B away from each other. Therefore, as illustrated in <FIG>, the engagement portion <NUM> of the main body portion <NUM> can pass over the engagement projections <NUM> in the direction of insertion A1 while sliding on the upper surfaces 54a of the engagement projections <NUM>.

As illustrated in <FIG>, when the engagement portion <NUM> of the main body portion <NUM> passes over the engagement projections <NUM> of the needle member <NUM>, the engagement projections <NUM> fit the engagement depression <NUM> of the main body portion <NUM>. Accordingly, the main body portion <NUM> of the movable member <NUM> and the holding portion <NUM> of the needle member <NUM> interfere in the longitudinal direction A. In other words, the needle member <NUM> and the movable member <NUM> are integrally movable in the longitudinal direction A. Specifically, when the movable member <NUM> is moved in the direction of removal A2, the inner surface of the engagement depression <NUM> of the main body portion <NUM> of the movable member <NUM> in the direction of insertion A1 comes into attachment with the outer surfaces of the engagement projection <NUM> of the holding portion <NUM> of the needle member <NUM> in the direction of insertion A1. Accordingly, the needle member <NUM> and the movable member <NUM> can be united and moved together in the direction of removal A2. Therefore, as illustrated in <FIG>, when removing the needle portion <NUM> from the living body, the movable portion <NUM> in the needle portion <NUM> can be removed from the living body together with the needle portion <NUM>.

Examples of the material of the main body portion <NUM> include a resin material. Examples of the resin material include: thermoplastic resins used in injection molding such as ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluorine resin, polycarbonate, polyamide, acetal resin, acrylic resin, and polyethylene terephthalate; and thermosetting resins such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester.

The housing <NUM> is an exterior member configured to cover the needle member <NUM>, the movable member <NUM>, the biasing member <NUM>, the controller <NUM>, and the sensor <NUM>, which is described below. As illustrated in <FIG>, the housing <NUM> of the present embodiment includes a cylindrical member <NUM> configured to cover the periphery of the needle member <NUM>, the movable member <NUM>, the biasing member <NUM>, the controller <NUM>, and the sensor <NUM>, described below, in the radial direction B, and a base plate <NUM> configured to cover an end surface of the cylindrical member <NUM> in the direction of insertion A1 in a state in which the needle portion <NUM> is in the waiting position (see <FIG>). The base plate <NUM> is attachable to and detachable from the cylindrical member <NUM>.

A surface of the base plate <NUM> on the side of the direction of insertion A1 constitutes an attachment surface 72a that is brought into attachment with the living body surface BS when the needle portion <NUM> and the sensor <NUM> are inserted into the living body. The base plate <NUM> includes a through-hole <NUM> that penetrates in the longitudinal direction A. When the needle portion <NUM> in the waiting position (see <FIG>) moves to the insertion position (see <FIG>), the needle portion <NUM> protrudes from the attachment surface 72a in the direction of insertion A1 through the through-hole <NUM>.

The configuration of the housing <NUM> is not specifically limited. In the present embodiment, the needle member <NUM> and the movable member <NUM> are movably attached to the housing <NUM> in the longitudinal direction A but may be movably attached to a member other than the housing <NUM>.

Although the insertion device <NUM> of the present embodiment includes the housing <NUM>, a configuration without the housing <NUM> is also applicable. However, like the housing <NUM> of the present embodiment, the insertion device <NUM> preferably includes a member that covers at least the outside periphery of the needle portion <NUM> in the waiting position in the radial direction B for reducing the probability that the health care workers or the patients erroneously touch the needle member <NUM>.

Also, although the housing <NUM> of the present embodiment is configured such that the cylindrical member <NUM> and the base plate <NUM> are attachable and detachable, it is not limited thereto, and both members may be formed integrally to each other. However, by configuring both members attachable and detachable, the size of a portion to be implantedon the living body surface BS can easily be reduced so that the burden of the subject can be alleviated.

Examples of the material of the housing <NUM> include a resin material. Examples of the resin material include: thermoplastic resins used in injection molding such as ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluorine resin, polycarbonate, polyamide, acetal resin, acrylic resin, and polyethylene terephthalate; and thermosetting resins such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester.

The biasing member <NUM> of the present embodiment is resiliently deformable in the longitudinal direction A. The biasing member <NUM> of the present embodiment is a coil spring which resiliently deforms in the longitudinal direction A. The coil spring as the biasing member <NUM> is disposed between the holding portion <NUM> of the needle member <NUM> and the base plate <NUM> of the housing <NUM>. Therefore, the coil spring as the biasing member <NUM> of the present embodiment is subject to compression deformation by the needle portion <NUM> moving from the waiting position (see <FIG>) to the insertion position (see <FIG>). Also, by releasing a restoring force of the coil spring as the biasing member <NUM> in a state in which the needle portion <NUM> is in the insertion position (see <FIG>), the needle portion <NUM> can be moved from the insertion position (see <FIG>) in the direction of removal A2.

Therefore, in the insertion device <NUM> of the present embodiment, when the needle member <NUM> and the sensor <NUM> are inserted into the living body, the needle member <NUM> and the movable member <NUM> described above are moved in the direction of insertion A1 against the restoring force of the coil spring as the biasing member <NUM>. Accordingly, as illustrated in <FIG> and <FIG>, the needle member <NUM> and the movable member <NUM> moves in the direction of insertion A1 and the needle portion <NUM> and the sensor <NUM> are inserted into the living body. By releasing the pressing force in the direction of insertion A1 applied to the needle member <NUM> and the movable member <NUM> after the insertion of the needle portion <NUM> and the sensor <NUM> into the living body, the needle member <NUM> and the movable member <NUM> move in the direction of removal A2 by the restoring force of the coil spring as the biasing member <NUM>. Accordingly, the needle portion <NUM> can be removed from the living body with the sensor <NUM> left in the living body. In the present embodiment, by the restoring force of the coil spring as the biasing member <NUM>, the needle portion <NUM> returns from the insertion position (see <FIG>) to a position (the waiting position as in the <FIG>, for example) of being accommodated in the housing <NUM> again(see <FIG>).

As described above, although the biasing member <NUM> of the present embodiment is composed of the coil spring, it is not limited to the coil spring, and other resilient members may be used, for example. Also, the insertion device <NUM> may be configured not to include the biasing member <NUM>.

The controller <NUM> is connected to the sensor <NUM> electrically or optically. Therefore, the controller <NUM> can receive detected information from the sensor <NUM> implantedin the living body. Also, as described above, the controller <NUM> analyzes the detection signal received from the sensor <NUM> and transmits the result of analysis to an external device such as a display apparatus as needed. The controller <NUM> includes a processor, a memory, and a battery.

As illustrated in <FIG>, the controller <NUM> of the present embodiment moves together with the needle portion <NUM> and the sensor <NUM> in the direction of insertion A1 when the needle portion <NUM> and the sensor <NUM> are inserted into the living body. More specifically, the controller <NUM> of the present embodiment is held by the needle member <NUM> in a state in which the needle portion <NUM> is in the waiting position (see <FIG>). When the needle portion <NUM> moves from the waiting position (see <FIG>) to the insertion position (see <FIG>), the controller <NUM> moves together with the needle member <NUM> in the direction of insertion A1. When the needle portion <NUM> reaches the insertion position (see <FIG>), the controller <NUM> engages the base plate <NUM> of the housing <NUM>, and the state of being held by the needle member <NUM> is released. Accordingly, the controller <NUM> assumes a state of being held on the base plate <NUM>. Therefore, when the needle portion <NUM> is removed from the living body, that is, when the needle portion <NUM> returns from the insertion position to the waiting position, the needle member <NUM> moves in the direction of removal A2. However, the controller <NUM> does not move in the direction of removal A2 and remains on the base plate <NUM> of the housing <NUM>.

The sensor <NUM> of the present embodiment is a linear member to be accommodated in the accommodation space <NUM> of the needle portion <NUM>. As the sensor <NUM>, a member configured to detect an electric signal corresponding to an amount or concentration of the substance to be measured can be used. The sensor <NUM> extends in the accommodation space <NUM> along the longitudinal direction A of the needle portion <NUM>.

The sensor <NUM> may be, for example, a wire electrode having a circular cross-section. The wire electrode is accommodated in the accommodation space <NUM> of the needle portion <NUM>. The outer diameter of the wire electrode may be, for example, from <NUM> to <NUM>. For example, two wire electrodes; a working electrode and a reference electrode, may be accommodated in the accommodation space <NUM>. The working electrode is formed basically of a core having a conductive surface and may be configured to include a detection portion <NUM> provided on an outer wall of the core and configured to detect the substance to be measured, and a protecting portion made of an insulating material coated on the outer wall of the core. Changes in electrical characteristics of the substance to be measured can be detected by the detection portion <NUM>. The detection portion <NUM> is formed on a core surface by using thin-film forming means such as dipping, electropolymerization, sputtering, and the like. A reagent that reacts specifically with the substance to be measured is applied on a surface of the working electrode. When the substance to be measured is glucose, a reagent containing glucose oxidase or a phenylboronic acid compounds is used. The reference electrode is used as a reference electrode for the working electrode described above. A single wire electrode formed by winding the reference electrode or a counter electrode in a coil shape around the working electrode is also applicable. Alternatively, three wire electrodes may be disposed in the accommodation space <NUM>. The three wire electrodes may be used to constitute the working electrode, the reference electrode, and the counter electrode. Alternatively, the needle portion <NUM> itself may be used as the reference electrode or the counter electrode. Information on the substance to be measured detected by the detection portion <NUM> of the working electrode is transmitted to the controller <NUM>.

Next, the details of the operation of the needle portion <NUM>, the movable portion <NUM>, and the sensor <NUM> when inserting and implanting the sensor <NUM> into the living body by using the insertion device <NUM> will be described. <FIG> is a drawing illustrating the needle portion <NUM>, the movable portion <NUM>, and the sensor <NUM> in the state in which the needle portion <NUM> is in the waiting position (see <FIG>). <FIG> is a drawing illustrating the needle portion <NUM>, the movable portion <NUM>, and the sensor <NUM> in the state in which the needle portion <NUM> is in the course of moving from the waiting position (see <FIG>) to the insertion position (see <FIG>). <FIG> is a drawing illustrating the needle portion <NUM>, the movable portion <NUM>, and the sensor <NUM> in the state in which the needle portion <NUM> is in the insertion position (see <FIG>). <FIG> is a drawing illustrating the needle portion <NUM>, the movable portion <NUM>, and the sensor <NUM> in the state in which the needle portion <NUM> is in the course of returning into the housing <NUM> after the sensor <NUM> has been implanted in the insertion position (see <FIG>).

As illustrated in <FIG>, in a state in which the needle portion <NUM> is in the waiting position, the sensor <NUM> is clamped by the clamping portion <NUM> of the needle portion <NUM>. Specifically, the sensor <NUM> is clamped between the inner surface of the sidewall portion <NUM> and the projection portion <NUM>, which constitute the clamping portion <NUM>. In other words, the clamping portion <NUM> illustrated in <FIG> is in the first form for clamping the sensor <NUM> in the accommodation space <NUM>. More specifically, the sensor <NUM> is clamped between the inner surface of the second side plate portion 15b of the sidewall portion <NUM> and the flap distal end portion <NUM> of the flap <NUM> as the projection portion <NUM> at a position in the direction of removal A2 with respect to the detection portion <NUM>. In this state, the end portion of the movable portion <NUM> in the direction of insertion A1 is located in the direction of removal A2 with respect to the clamping portion <NUM>.

Although the clamping portion <NUM> of the present embodiment clamps the sensor <NUM> at a predetermined position located in the direction of removal A2 with respect to the detection portion <NUM>, the position is not specifically limited as long as it is a position other than the detection portion <NUM>. However, in order to reliably insert the detection portion <NUM> to the desired depth in the living body, the clamping portion <NUM> preferably clamps the distal end portion of the sensor <NUM> in the direction of insertion A1. Further, as in the present embodiment, the clamping portion <NUM> preferably clamps the sensor <NUM> at a predetermined position located in the direction of removal A2 with respect to the detection portion <NUM>. In this configuration, the movable portion <NUM> moving in the direction of insertion A1 and engaging the clamping portion <NUM> is restrained from sliding together with the detection portion <NUM>, whereby damage of the detection portion <NUM> may be reduced.

As illustrated in <FIG>, the needle member <NUM> and the movable member <NUM> both move in the direction of insertion A1 in the course of movement of the needle portion <NUM> from the waiting position (see <FIG>) to the insertion position (see <FIG>). As illustrated in <FIG>, the relative positional relationship between the needle member <NUM> and the movable member <NUM> in the longitudinal direction A varies in the course of movement of the needle portion <NUM> from the waiting position (see <FIG>) to the insertion position (see <FIG>). In other words, the needle member <NUM> and the movable member <NUM> both move in the direction of insertion A1 in the course of movement of the needle portion <NUM> from the waiting position (see <FIG>) to the insertion position (see <FIG>), and the movable member <NUM> moves also relatively to get closer to the needle member <NUM> in the direction of insertion A1. Therefore, as illustrated in <FIG>, the movable portion <NUM> of the movable member <NUM> moves in the direction of insertion A1 with respect to the needle portion <NUM> of the needle member <NUM> in the course of movement of the needle portion <NUM> from the waiting position (see <FIG>) to the insertion position (see <FIG>). Accordingly, the movable portion <NUM> moves to a position engaging the clamping portion <NUM> of the needle portion <NUM>. <FIG> illustrates a state in which the end portion of the first groove wall portion 21a of the movable portion <NUM> in the direction of insertion A1 engages the flap <NUM> as the projection portion <NUM>, which constitutes the clamping portion <NUM> of the needle portion <NUM>.

As illustrated in <FIG>, the end portion of the first groove wall portion 21a of the movable portion <NUM> in the direction of insertion A1 engages the inclined portion <NUM> of the flap <NUM> to resiliently deform the inclined portion <NUM> so as to get closer to the first side plate portion 15a. Therefore, as illustrated in <FIG>, the flap distal end portion <NUM> of the flap <NUM> moves away from the second side plate portion 15b. Accordingly, the clamped state of the sensor <NUM> by the clamping portion <NUM> of the needle portion <NUM> may be released. In this manner, when the needle portion <NUM> reaches the insertion position (see <FIG> and <FIG>), the sensor <NUM> is released from being clamped by the clamping portion <NUM> of the needle portion <NUM>, and a state of being movable relative to the needle portion <NUM> in the longitudinal direction A is achieved. In other words, the clamping portion <NUM> illustrated in <FIG> is in the second form for not clamping the sensor <NUM> in the accommodation space <NUM>.

In this manner, the movable portion <NUM> of the present embodiment changes the form of the clamping portion <NUM> from the first form to the second form by moving in the direction of insertion A1 with respect to the needle portion <NUM> and engaging the projection portion <NUM> and deforming the projection portion <NUM>. Accordingly, the sensor <NUM> is unlikely to be caught by the needle portion <NUM> when the needle portion <NUM> is removed from the living body. Therefore, as illustrated in <FIG>, the needle portion <NUM> and the movable portion <NUM> can easily be removed from the living body with the sensor <NUM> left at a predetermined depth in the living body.

As described above, in the insertion device <NUM> of the present embodiment, the needle portion <NUM> clamps the sensor <NUM> while the needle portion <NUM> moves from the waiting position (see <FIG> and <FIG>) to the insertion position (see <FIG> and <FIG>). Therefore, the sensor <NUM> can easily be inserted to the desired depth in the living body. When the needle portion <NUM> reaches the insertion position, the clamped state of the sensor <NUM> by the needle portion <NUM> is released. Therefore, the sensor <NUM> is unlikely to be caught by the needle portion <NUM> when the needle portion <NUM> is removed from the living body. Therefore, the sensor <NUM> is restrained from moving in the direction of removal A2 and being displaced from the desired depth when the needle portion <NUM> is removed from the living body. Therefore, the sensor <NUM> can easily be implanted at the desired depth in the living body.

The insertion device <NUM> of the present embodiment includes the restricting mechanism <NUM>. Specifically, the insertion device <NUM> of the present embodiment includes the rib <NUM> of the needle portion <NUM> and the receiving groove <NUM> of the movable portion <NUM>. Therefore, the needle portion <NUM> and the movable portion <NUM> can easily be moved in the longitudinal direction A. The first groove wall portion 21a and the second groove wall portion 21b of the movable portion <NUM> of the present embodiment are interposed between the first side plate portion 15a and the second side plate portion 15b, opposing each other, of the needle portion <NUM>. Therefore, the movable portion <NUM> is restricted from moving in an opposing direction between the first side plate portion 15a and the second side plate portion 15b of the needle portion <NUM>. Therefore, in the insertion device <NUM> of the present embodiment, in addition to the rib <NUM> and the receiving groove <NUM> described above, the first groove wall portion 21a and the second groove wall portion 21b of the movable portion <NUM>, as well as the first side plate portion 15a and the second side plate portion 15b of the needle portion <NUM>, constitute the restricting mechanism <NUM>.

<FIG> is a drawing illustrating a needle portion <NUM> as a modification of the needle portion <NUM>. <FIG> is a cross-sectional view of the needle portion <NUM> and the movable portion <NUM> taken along a cross section orthogonal to the longitudinal direction A. As illustrated in <FIG>, the needle portion <NUM> is provided with a first turned-back portion 15d continuing to the other end of the first side plate portion 15a, which is the opposite side of the one end continuing to the third side plate portion 15c. Also, the needle portion <NUM> is provided with a second turned-back portion 15e continuing to the other end of the second side plate portion 15b, which is the opposite side of the one end continuing to the third side plate portion 15c. The one end of the first groove wall portion 21a of the movable portion <NUM> on the opposite side from the one end continuing to the groove bottom portion 21c is covered with the first turned-back portion 15d. Also, the end of the second groove wall portion 21b of the movable portion <NUM> on the opposite side from the one end continuing to the groove bottom portion 21c is covered with the second turned-back portion 15e. To allow the needle portion <NUM> and the movable portion <NUM> to slide in the longitudinal direction A, a clearance of <NUM> to <NUM> may be provided between the first turned-back portion 15d and the first groove wall portion 21a and between the second turned-back portion 15e and the second groove wall portion 21b. By providing the first turned-back portion 15d and the second turned-back portion 15e in this configuration, the movable portion <NUM> is restrained from slipping off a gap <NUM> of the needle portion <NUM>. That is, in the example illustrated in <FIG>, the first turned-back portion 15d and the second turned-back portion 15e also constitute the restricting mechanism <NUM> configured to restrict the relative movement of the needle portion <NUM> and the movable portion <NUM> in directions other than in the longitudinal direction A. Also, in the needle portion <NUM> and the movable portion <NUM> in <FIG>, the receiving groove <NUM> and the rib <NUM> may not be provided.

In this manner, the configuration of the restricting mechanism <NUM> is not specifically limited as long as it is configured to restrict the relative movement of the needle portion and the movable portion in directions other than the longitudinal direction A.

Referring next to <FIG> and <FIG>, a method of manufacturing the needle portion <NUM> described above will be described. <FIG> is a flowchart showing an example of the method of manufacturing the needle portion <NUM>. <FIG> is a drawing illustrating an overview of respective processes of the method of manufacturing illustrated in <FIG>. The method of manufacturing the needle portion <NUM> illustrated in <FIG> includes: a punching process S1 for punching out a rectangular plate-shaped unfolded body <NUM> that becomes the needle portion <NUM>, a press process S2 for pressing the unfolded body <NUM> by a pressing and shaping machine <NUM> to form a rod member <NUM> having a rectangular groove-shaped cross-section; a flap push-in process S3 for pushing a rectangular strip that becomes the flap <NUM>, to form the flap <NUM>, and a sharpening process S4 for forming a cutting edge on one end portion of the rod member <NUM> having a rectangular groove-shaped cross-section. In the method of manufacturing the needle portion <NUM> illustrated in <FIG>, in the punching process S1 for forming the rectangular plate-shaped unfolded body <NUM>, a slit <NUM> for forming a rectangular strip that becomes an original of the flap <NUM>, is formed. Therefore, in the flap push-in process S3, the flap <NUM> is formed by pushing the rectangular strip formed by being surrounded by the slit <NUM>. In the press process S2, the rib <NUM>, which constitutes the restricting mechanism <NUM> of the needle portion <NUM>, is preferably formed at the same time. Also, in the press process S2, the rod member <NUM> having a rectangular groove-shaped cross-section is formed by gradually curving by using a plurality of molds in sequence. In the method of manufacturing the needle portion <NUM> illustrated in <FIG>, the sharpening process S4 is included after the formation of the rod member <NUM> having the rectangular groove-shaped cross-section. However, a cutting edge shape may be formed in advance at a distal end portion of the unfolded body <NUM> in the punching process S1.

In addition, the method of manufacturing the needle portion <NUM> illustrated in <FIG> may further include other processes such as a grinding process of the needle portion <NUM> in addition to the processes S1 to S4 described above. In addition, a process of forming the first turned-back portion 15d and the second turned-back portion 15e illustrated in <FIG> may further be included.

The needle member <NUM> is manufactured by joining the needle portion <NUM> manufactured by the method of manufacturing illustrated in <FIG> to the holding portion <NUM>. The needle portion <NUM> and the holding portion <NUM> are joined, for example, by fusion bonding, adhesion, and the like.

<FIG> is a flowchart illustrating a modified example of a method of manufacturing the needle portion <NUM> illustrated in <FIG>. The needle portion <NUM> is formed from the flat plate-shaped unfolded body <NUM> in the method of manufacturing illustrated in <FIG>. However, in the method of manufacturing illustrated in <FIG>, the needle portion <NUM> is formed from the half-tubular member. Specifically, the method of manufacturing the needle portion <NUM> illustrated in <FIG> includes: a half-tube acquiring process S1 for acquiring the half-tubular member; a flap cutting process S2 for forming a rectangular strip that becomes the flap <NUM>, by cutting part of the half-tubular member; a rib forming process S3 for forming the rib <NUM> on a depressed-shaped inner surface of the half-tubular member; a press process S4 for pressing the half-tubular member by the pressing and shaping machine <NUM> to form a rod member <NUM> having a rectangular groove-shaped cross-section; a flap push-in process S5 for pushing the rectangular strip that becomes the flap <NUM>, to form the flap <NUM>; and a sharpening process S6 for forming a cutting edge on one end portion of the rod member <NUM> having a rectangular groove-shaped cross-section.

In the flap cutting process S2, a slit <NUM> is formed by, for example, laser processing. In the flap push-in process S5, the flap <NUM> is formed by pushing the rectangular strip formed by being surrounded by the slit <NUM>. In <FIG>, although the rib forming process S3 is included separately from the press process S4, the rib <NUM> may be formed at the same time in the press process S4. In the method of manufacturing the needle portion <NUM> illustrated in <FIG>, the sharpening process S6 is included after the formation of the rod member <NUM> having the rectangular groove-shaped cross-section. However, the cutting edge shape may be formed in advance before the press process S4.

Claim 1:
An insertion device (<NUM>) for inserting a medical device into a living body, comprising:
a needle portion (<NUM>, <NUM>) internally defining an accommodation space (<NUM>) for accommodating the medical device and configured to be inserted into a living body together with the medical device to be accommodated in the accommodation space (<NUM>); and
a movable portion (<NUM>) relatively movable with respect to the needle portion (<NUM>, <NUM>) in the accommodation space (<NUM>) in a direction of insertion (A1) of the needle portion (<NUM>, <NUM>),
wherein the needle portion (<NUM>, <NUM>) comprises a clamping portion (<NUM>) configured to change a form in the accommodation space (<NUM>) between a first form in which the clamping portion (<NUM>) clamps the medical device accommodated in the accommodation space (<NUM>) and a second form in which the clamping portion (<NUM>) does not clamp the medical device accommodated in the accommodation space (<NUM>), and
the movable portion (<NUM>) is configured to engage the clamping portion (<NUM>) by moving in the direction of insertion (A1) with respect to the needle portion (<NUM>, <NUM>) to change the form of the clamping portion (<NUM>) from the first form to the second form.