JP7313228B2 - insertion device - Google Patents

Description

The present disclosure relates to insertion devices and needle members.

Conventionally, there are cases in which a medical device such as a sensor is embedded in the body of a person to be measured such as a patient. As an example, a sensor is implanted in the subject's body to monitor analytes (eg, glucose, pH, cholesterol, protein, etc.) in the subject's blood or bodily fluids. In this case, an insertion device is used to quickly and easily embed the sensor in the living body by penetrating the skin of the subject (see Patent Document 1).

A medical device inserter as an insertion device described in Patent Document 1 includes a sharp member inserted together with a sensor, and a plunger that moves the sensor and the sharp member to perform puncture. According to this insertion device, the mounting unit can be left in the living body together with the sensor inserted into the living body. The attachment unit also includes a wearable electronic device that stores the acquired biometric information of the blood glucose level.

Japanese Patent Application Publication No. 2013-523217

Medical devices such as tubular members and sensors that are implanted and left in the living body preferably have a small diameter in order to reduce the burden such as pain on the person to be measured during the placement. Moreover, it is preferable that the diameter of the needle member, which accommodates the medical device and is inserted into the living body together with the medical device, is reduced in order to reduce the pain of the subject during insertion.

However, when the diameter of the medical device and the needle member is reduced, it is difficult to accommodate the medical device within the needle member.

An object of the present disclosure is to provide an insertion device and a needle member having a configuration that facilitates accommodation of a medical device within the needle member.

As a first aspect of the present disclosure, an insertion device is an insertion device for inserting a medical device into a living body, comprising: a needle member having a plurality of needle pieces to be inserted into the living body together with the medical device housed in the housing space; and a variable mechanism capable of varying the cross-sectional area of the housing space in the radial direction by moving the plurality of needle pieces toward or away from each other in the radial direction of the needle member.

An insertion device according to one embodiment of the present disclosure includes a housing that holds the needle member movably in the axial direction, and an urging mechanism that can urge the needle piece radially inwardly or outwardly.

In one embodiment of the present disclosure, the needle member is movable between a standby position housed in the housing and an insertion position protruding from the housing, and the force exerted by the biasing mechanism on the needle piece inward in the radial direction is reduced as the needle member moves from the standby position to the insertion position.

In one embodiment of the present disclosure, the biasing mechanism biases the needle piece radially inward when the needle member is at the standby position, and does not bias the needle piece radially inward when the needle member is at the insertion position.

As one embodiment of the present disclosure, the biasing mechanism biases the needle piece outward in the radial direction when the needle member is in the insertion position.

In one embodiment of the present disclosure, the biasing mechanism includes a pressing portion provided in the housing, which presses the needle piece outward in the radial direction by directly or indirectly engaging with the needle piece when the needle member moves from the standby position to the insertion position.

A needle member according to a second aspect of the present disclosure is a needle member used in an insertion device for inserting a medical device into a living body, the needle member defines a storage space capable of housing the medical device on the inner side in the radial direction, and includes a plurality of needle pieces to be inserted into the living body together with the medical device stored in the storage space.

According to the present disclosure, it is possible to provide an insertion device and a needle member having a configuration that facilitates accommodation of a medical device within the needle member.

FIG. 4 is a view showing the insertion device as the first embodiment, and showing a state in which the needle member is at the standby position; FIG. 1B is a view of the insertion device shown in FIG. 1A with the needle member in the insertion position; FIG. 1B is a view showing the insertion device shown in FIG. 1A placed on a living body surface; FIG. 2B is a diagram showing a state in which the needle member and the medical device are being inserted into the living body by operating the insertion device shown in FIG. 2A; FIG. FIG. 2C is a diagram showing a state in which the needle member and the medical device have advanced further in the insertion direction from the state of FIG. 2B and the needle member has reached the deepest position in the living body; It is a figure which shows a mode that the needle member is extracted outside the living body, leaving a medical instrument in the living body from the state of FIG. 2C. FIG. 10 is a diagram showing an insertion device as a second embodiment, showing a state in which the needle member is at the standby position before the medical instrument is left in the living body. Figure 3B shows the insertion device shown in Figure 3A with the needle member in the insertion position; FIG. 3C is a view of the insertion device shown in FIG. 3A, showing a state in which the needle member has returned to the standby position after the medical device has been left in the living body in the state of FIG. 3B; FIG. 3B is a cross-sectional view taken along line I-I of FIG. 3A; FIG. 3C is a cross-sectional view taken along line II-II of FIG. 3B; FIG. 3C is a cross-sectional view taken along line III-III of FIG. 3C; FIG. 10 is a diagram showing an insertion device as a third embodiment, showing a state in which the needle member is at the standby position before the medical device is left in the living body. Figure 5B shows the insertion device shown in Figure 5A with the needle member in the insertion position; FIG. 5C is a view of the insertion device shown in FIG. 5A, showing a state in which the needle member has returned to the standby position after the medical device has been left in the living body in the state of FIG. 5B. FIG. 5B is a cross-sectional view taken along line IV-IV of FIG. 5A; FIG. 5C is a cross-sectional view along line V-V of FIG. 5B; FIG. 5C is a cross-sectional view taken along line VI-VI of FIG. 5C; 4 is a flow chart showing an example of a method for manufacturing a needle unit composed of a needle piece and a holding piece in the insertion device of the first embodiment; It is a figure which shows the outline|summary of the bending press process shown in FIG.

Hereinafter, embodiments of an insertion device and a needle member according to the present disclosure will be described with reference to the drawings. The same reference numerals are given to the members/parts that are common in each figure.

(First embodiment)
1A and 1B are diagrams showing an insertion device 1 as one embodiment of an insertion device according to the present disclosure. Although details will be described later, FIG. 1A shows a state in which the needle member 2 is at the standby position. FIG. 1B shows the needle member 2 in the inserted position. The insertion device 1 shown in FIGS. 1A and 1B can insert a sensor 100a as a medical device 100 into a living body. In the present embodiment, the insertion device 1 for inserting the sensor 100a as the medical device 100 into the living body will be described below, but the medical device 100 inserted into the living body by the insertion device 1 is not limited to the sensor 100a. Therefore, it may be an insertion device for inserting a tubular member such as a cannula other than a sensor.

As shown in FIGS. 1A and 1B, the insertion device 1 includes a needle member 2, a variation mechanism 3, a housing 4, a biasing mechanism 5, an operating member 7, a biasing member 8, and a sensor 100a as a medical instrument 100. The variation mechanism 3 of this embodiment is composed of a holding member 6 . The biasing mechanism 5 of this embodiment is configured by a pressing portion 31 provided in the housing 4 .

First, how to use the insertion device 1 of this embodiment will be described. The insertion device 1 of this embodiment can be used for inserting and indwelling the sensor 100a as the medical device 100 as described above. The insertion device 1 is placed on the living body surface in the state shown in FIG. 1A. Thereafter, by operating the insertion device 1, the insertion device 1 is brought into the state shown in FIG. 1B. As a result, the needle member 2 and the sensor 100a housed in the needle member 2 are inserted into the living body. Next, with the sensor 100a left in the living body, the needle member 2 is removed from the living body. By doing so, the insertion device 1 can insert and indwell the sensor 100a in the living body.

A sensor 100a placed in a living body has a portion that reacts with a substance to be measured (analyte). The control device is connected to the sensor 100a and placed on the biological surface together with the sensor 100a. The control device is composed of a processor, a memory, a battery, and the like. The sensor 100a can detect a signal according to the concentration of the substance to be measured by using it with a control device. The detection signal is digitally converted by the control device and sent to the subject's smartphone or dedicated terminal. The person being measured or the user can check the measurement results of the substance to be measured displayed on the screen of the smartphone or dedicated terminal over time. While the person to be measured is wearing the sensor 100a, the substance to be measured in the body fluid of the person to be measured is measured over time. The period during which the sensor 100a is attached to the person to be measured is appropriately determined by a doctor or the like, such as several hours, several days, one week, or one month. The substance to be measured is not particularly limited, but glucose, oxygen, pH, lactic acid, etc. in blood or interstitial fluid can be measured by selecting the detection part of the sensor.

Details of each member and each part of the insertion device 1 will be described below. In this specification, the end of the needle member 2 that is inserted into the living body is referred to as the "tip". Also, the end opposite to the tip of the needle member 2 is referred to as the "base end". Further, the direction from the proximal end to the distal end of the axial direction A of the needle member 2 is described as "insertion direction A1" or "distal side". Further, the direction from the distal end to the proximal end of the axial direction A of the needle member 2 is referred to as the "withdrawal direction A2" or "the proximal side". In addition, the circumferential direction along the circumferential surface of the needle member 2 in the cross section is defined as "circumferential direction C".

The needle member 2 has a plurality of needle pieces 11 . The needle member 2 of this embodiment is formed by a plurality of needle pieces 11 as a whole. FIG. 1A shows a state in which the plurality of needle pieces 11 are closest to each other inward in the radial direction B of the needle member 2 by the movement mechanism 3, which will be described later. That is, it shows the state in which the maximum inner diameter of the needle member 2 (the maximum distance between the needle pieces 11) is the smallest. As shown in FIG. 1A, in the present embodiment, both circumferential end surfaces of each needle piece 11 abut against the end surface of another adjacent needle piece 11 . The needle member 2 thereby forms a tubular hollow needle. FIG. 1B shows a state in which a plurality of needle pieces 11 are spaced apart from each other outward in the radial direction B by a movement mechanism 3, which will be described later, compared to the state shown in FIG. 1A. That is, the maximum inner diameter of the needle member 2 shown in FIG. 1B is larger than the maximum inner diameter of the needle member 2 shown in FIG. 1A. By moving the needle member 2 in the insertion direction A1, the inner diameter of the needle member 2 at each position in the axial direction A of the needle member 2 becomes larger than before the movement in the insertion direction A1. At this time, the positional relationship of the needle pieces 11 in the longitudinal direction of the needle pieces 11 is the same as that shown in FIG. 1A. Further, in the present embodiment, both circumferential end faces of each needle piece 11 do not contact the end face of another adjacent needle piece 11 in the state shown in FIG. 1B. A plurality of needle pieces 11 define a storage space 12 in which the medical device 100 can be stored inside in the radial direction B. As shown in FIG. In this embodiment, when all the end surfaces of the plurality of needle pieces 11 in the circumferential direction C are in contact with each other, the housing space 12 refers to the space surrounded by the plurality of needle pieces 11 . Further, in this embodiment, when the plurality of needle pieces 11 are spaced apart, the accommodation space 12 refers to a space surrounded by the plurality of needle pieces 11 and the slit-shaped separation portion between the end faces of the plurality of needle pieces 11. The accommodation space 12 can also be said to be a space surrounded by a plurality of needle pieces 11 . The accommodation space 12 is widened by the movement of the needle piece 11 outward in the radial direction B. As shown in FIG. The plurality of needle pieces 11 are inserted into the living body together with the medical device 100 housed in the housing space 12 . At this time, both end surfaces of each needle piece 11 in the circumferential direction C are brought into contact with the end surfaces of other adjacent needle pieces 11, so that the maximum inner diameter of the needle member 2 is the smallest. Thereby, even if the medical device 100 is a flexible sensor 100a or the like, the medical device 100 can be inserted to a predetermined depth in the living body.

The needle member 2 of the present embodiment includes two semi-tubular needle pieces 11a and 11b arranged facing each other in the radial direction B, but the number and shape of the needle pieces 11 are not particularly limited. Hereinafter, when describing each needle piece 11 without distinguishing it, it is simply described as "the needle piece 11". The needle member 2 may have three or more needle pieces 11 . The cross-sectional shape of the needle piece 11 is also not particularly limited. However, like the plurality of needle pieces 11 of the present embodiment, it is preferable that the end faces are connected to each other in the circumferential direction C to form a circular cross-sectional shape as a whole. By doing so, the piercing resistance when the needle member 2 is inserted can be reduced. Therefore, in the case of the needle member 2 having arbitrary N needle pieces 11, it is preferable that the cross-sectional shape of each needle piece 11 is an arc shape with a central angle of 360°/N.

As shown in FIG. 1A, a sharp cutting edge is formed at the distal end of the needle member 2 in a state in which the plurality of needle pieces 11 are arranged close to the inner side in the radial direction B. As shown in FIG. In other words, the tip of each needle piece 11 is formed with a conical blade surface so that the plurality of needle pieces 11 as a whole form one sharp cutting edge. In this embodiment, the blade surfaces of the plurality of needle pieces 11 form a pencil point as a whole. In other words, the needle member 2 configured with the plurality of needle pieces 11 close to the inner side in the radial direction B serves as a pencil needle. However, the shape of the cutting edge formed by the plurality of needle pieces 11 as a whole is not limited to the pencil point of the present embodiment. Alternatively, the needle member may have a tip opening formed in a state in which the plurality of needle pieces 11 are closest to the inner side in the radial direction B. As shown in FIG. The details of the configuration of the distal end of such a needle member will be described later (see FIG. 3A, etc.).

In the present embodiment, the tubular needle member 2 formed by the plurality of needle pieces 11 closest to each other in the radial direction B is provided with an insertion portion 2a on the distal side that is inserted into the living body and a large-diameter portion 2b on the proximal side that is not inserted into the living body. The outer diameter of the insertion portion 2a is smaller than the outer diameter of the large diameter portion 2b. The outer diameter of the insertion portion 2a is, for example, 0.2 mm to 0.4 mm. The length of the insertion portion 2a is 1 mm to 10 mm, preferably 3 to 6 mm. Also, the thickness of the insertion portion 2a is set, for example, within the range of 0.02 mm to 0.15 mm. The outer diameter of the large diameter portion 2b is, for example, 0.3 mm to 0.5 mm. Moreover, the length of the large-diameter portion 2b is 1 mm to 10 mm, preferably 3 to 6 mm. Also, the thickness of the large-diameter portion 2b is set, for example, within the range of 0.05 mm to 0.2 mm.

The needle member 2 of the present embodiment is movable between a standby position housed in a housing 4 (to be described later) and an insertion position protruding from the housing 4 . Here, the state in which the needle member 2 is at the standby position means a state in which the tip of the needle member 2 is positioned within the housing 4 and does not protrude from the housing 4 . In this embodiment, the tip of the needle member 2 does not protrude in the insertion direction A1 beyond the contact surface 62a of the base plate portion 62 of the housing 4, which will be described later. The state in which the needle member 2 is in the insertion position means the state in which the distal end of the needle member 2 protrudes from the housing 4 to the outside. In this embodiment, the distal end of the needle member 2 protrudes most in the insertion direction A1 from the contact surface 62a of the base plate portion 62 of the housing 4, which will be described later. FIG. 1A shows the needle member 2 in the standby position. The needle member 2 of the present embodiment is inserted into the living body by moving from the standby position (see FIG. 1A) to the insertion position (see FIG. 1B) while the medical device 100 is stored in the storage space 12. The needle member 2 of this embodiment is then withdrawn outside the living body while the medical device 100 remains inside the living body.

As the material of the needle member 2, for example, metal materials such as stainless steel, aluminum, aluminum alloys, titanium, and titanium alloys can be used.

The variation mechanism 3 can move the plurality of needle pieces 11 toward or away from each other in the radial direction B. As shown in FIG. Thereby, the variation mechanism 3 can vary the cross-sectional area in the radial direction B of the accommodation space 12 . The cross-sectional area of the accommodation space 12 in the radial direction B means the cross-sectional area of the needle member 2 in a cross section perpendicular to the axial direction A. As shown in FIG.

Specifically, the variation mechanism 3 of this embodiment is composed of a holding member 6 that holds the proximal end of the needle member 2 . The holding member 6 of this embodiment includes a plurality of holding pieces 21 that separately hold a plurality of needle pieces 11 . Specifically, the holding member 6 of this embodiment includes a first holding piece 21a that holds the proximal end of one needle piece 11a, and a second holding piece 21b that holds the proximal end of the other needle piece 11b. Hereinafter, when each holding piece 21 is described without distinction, it is simply described as "holding piece 21". The proximal end of one needle piece 11a is fixed to the first holding piece 21a by welding or the like, and integrated. In this manner, one needle piece 11a is held by the first holding piece 21a so that the tip end thereof protrudes from the first holding piece 21a. The other needle piece 11b is also fixed to the second holding piece 21b by welding or the like and integrated. The needle piece 11b on the other side is also held by the second holding piece 21b so that the distal end thereof protrudes from the second holding piece 21b.

The first holding piece 21a and the second holding piece 21b are attached movably in the axial direction A of the needle member 2 with respect to the housing 4, which will be described later. On the other hand, the relative positional relationship in the axial direction A does not change between the first holding piece 21a and the second holding piece 21b. In other words, both the first holding piece 21a and the second holding piece 21b of this embodiment are axially movable with respect to the housing 4 .

The first holding piece 21a and the second holding piece 21b are attached to the housing 4, which will be described later, so as to be movable in the radial direction B of the needle member 2. As shown in FIG. Furthermore, the first holding piece 21a and the second holding piece 21b can move in the radial direction B relative to each other. That is, the first holding piece 21a and the second holding piece 21b of the present embodiment are separately movable in the radial direction B with respect to the housing 4. As shown in FIG. Therefore, the first holding piece 21a and the second holding piece 21b can approach or separate in the radial direction B. As shown in FIG. As a result, one needle piece 11a and the other needle piece 11b can move in the radial direction B relative to each other.

As described above, the number of needle pieces 11 is not limited to two shown in this embodiment. When the needle member 2 has three or more needle pieces 11, each of at least two holding pieces 21 may hold one or more needle pieces 11, and the number of needle pieces 11 held by each holding piece 21 is not particularly limited.

In this manner, the insertion device 1 includes a movement mechanism 3 that enables movement in the radial direction B of the needle piece 11 of the needle member 2 . Therefore, the cross-sectional area in the radial direction B of the accommodation space 12 defined by the plurality of needle pieces 11 of the needle member 2 can be varied. By changing this cross-sectional area, it becomes easier to accommodate the medical device 100 in the accommodation space 12 .

Further, the holding piece 21 of the present embodiment includes a locking claw portion 23 that engages with a pressing portion 31 of the housing 4, which will be described later. More specifically, the holding piece 21 of this embodiment includes a main body portion 22 and an engaging claw portion 23 protruding from the main body portion 22 in the insertion direction A1. The locking claw portion 23 includes a plate-like extension portion 24 and an engaging convex portion 25 . The plate-shaped extension portion 24 extends from the main body portion 22 in the insertion direction A1. The engaging convex portion 25 protrudes inward in the radial direction B from the end portion of the extension portion 24 in the insertion direction A1. An end surface 25a of the engaging projection 25 in the insertion direction A1 is formed of an inclined surface that is inclined with respect to the axial direction A. As shown in FIG. This inclined surface is inclined so as to extend outward in the radial direction B toward the insertion direction A1. Although the details will be described later, the locking claw portion 23 of the holding piece 21 of this embodiment engages with the pressing portion 31 of the housing 4 when the needle member 2 moves from the standby position (see FIG. 1A) to the insertion position (see FIG. 1B). As a result, the locking claw portion 23 is pressed outward in the radial direction B by the pressing portion 31 . That is, the needle piece 11 is pushed outward in the radial direction B by the pushing portion 31 indirectly via the locking claw portion 23 of the holding piece 21 .

Further, the holding piece 21 of the present embodiment is provided with a locking claw portion 26 that protrudes from the body portion 22 in the removal direction A2 and is hooked on a ceiling wall portion 63 of the housing 4, which will be described later. The needle member 2 is maintained at the standby position (see FIG. 1A) by hooking the locking claw portion 26 on the top wall portion 63 . Further, the standby position (see FIG. 1A) of the needle member 2 is released by removing the engagement of the locking claw portion 26 with the top wall portion 63 . Specifically, in this embodiment, by operating the operation member 7 attached to the housing 4 , the locking claw portion 26 can be released from the ceiling wall portion 63 . As a result, the holding piece 21 is moved in the insertion direction A1 by the restoring force of the coil spring as the biasing member 8, and the needle member 2 is moved to the insertion position (see FIG. 1B).

The housing 4 is an exterior member that covers the needle member 2, the holding member 6 as the movement mechanism 3, and the medical device 100, which will be described later. As shown in FIGS. 1A and 1B, the housing 4 of the present embodiment includes a tubular portion 61 that surrounds the needle member 2 and the medical device 100 in the radial direction B, a base plate portion 62 that covers the end surface of the tubular portion 61 in the insertion direction A1, and a top wall portion 63 that covers the end surface of the tubular portion 61 in the removal direction A2.

The surface of the base plate portion 62 in the insertion direction A1 constitutes an abutting surface 62a that abuts against the surface of the living body when the needle member 2 and the medical device 100 are inserted into the living body. A through hole 64 is formed through the base plate portion 62 in the axial direction A. As shown in FIG. When the needle member 2 moves from the waiting position to the insertion position, the needle member 2 protrudes from the contact surface 62a through the through hole 64 in the insertion direction A1.

In addition, the base plate portion 62 of the present embodiment includes a flat plate-like main body portion 66 and a projecting portion 67 projecting from the main body portion 66 into the cylindrical portion 61 in the removal direction A2. The contact surface 62a described above is formed by the surface of the body portion 66 in the insertion direction A1.

The top wall portion 63 is formed with a through hole 65 through which the above-described locking claw portion 26 is inserted. The locking claw portion 26 of the holding piece 21 described above protrudes from the inside of the tubular portion 61 to the outside of the tubular portion 61 through the through hole 65 and is hooked on the top surface of the top wall portion 63 in the removal direction A2. As a result, the standby position (see FIG. 1A) of the needle member 2 is maintained as described above. Further, as described above, the needle member 2 moves from the standby position to the insertion position (see FIG. 1B) by releasing the hooking of the locking claw portion 26 from the top wall portion 63 .

The configuration of the housing 4 is not particularly limited. In this embodiment, as described above, the needle member 2 and the holding member 6 as the variation mechanism 3 are movably attached to the housing 4, but they may be movably attached to a member other than the housing 4.

Furthermore, the insertion device 1 of the present embodiment includes the housing 4 that covers the needle member 2, the holding member 6 as the movement mechanism 3, and the medical device 100, which will be described later. However, like the housing 4 of the present embodiment, the insertion device 1 preferably includes a member that covers at least the outer circumference of the needle member 2 in the radial direction B in order to prevent medical personnel, patients, and the like from accidentally touching the needle member 2.

Further, in the housing 4 of the present embodiment, the tubular portion 61, the base plate portion 62, and the ceiling wall portion 63 are formed integrally.

Further, the housing 4 of the present embodiment includes a pressing portion 31 that constitutes the biasing mechanism 5, which will be described later. The pressing portion 31 of the present embodiment is configured by the tip surface of the projecting portion 67 of the base plate portion 62 of the housing 4 . When the needle member 2 moves from the standby position (see FIG. 1A) to the insertion position (see FIG. 1B), the pressing portion 31 of the present embodiment engages with the locking claw portion 23 of each holding piece 21 of the holding member 6, and indirectly presses the needle piece 11 outward in the radial direction B via each holding piece 21. Further, the pressing portion 31 of the present embodiment is configured by an inclined surface that is inclined with respect to the axial direction A. As shown in FIG. More specifically, the pressing portion 31 of this embodiment is inclined so as to extend outward in the radial direction B toward the insertion direction A1. The inclined surface as the pressing portion 31 engages with the inclined surface forming the end surface 25a of the engaging projection 25 of the locking claw portion 23 of the holding piece 21 in the insertion direction A1, and presses the needle piece 11 outward in the radial direction B through the holding piece 21.

Furthermore, the housing 4 of this embodiment comprises an engagement recess 32 . The engaging protrusions 25 of the locking claws 23 of the holding pieces 21 are fitted into the engaging recesses 32 . More specifically, when the needle member 2 moves from the standby position (see FIG. 1A) to the insertion position (see FIG. 1B), the engaging protrusions 25 of the locking claws 23 of the holding pieces 21 are pressed outward in the radial direction B while sliding on the pressing portions 31 of the housing 4. When the engaging projection 25 of the locking claw portion 23 of the holding piece 21 climbs over the pressing portion 31 of the housing 4 , the engaging projection 25 fits into the engaging recess 32 . As a result, the engaging projection 25 and the engaging recess 32 interfere with each other in the axial direction A. As shown in FIG. Details of this will be described later.

Examples of materials for the housing 4 include resin materials. The resin material includes, for example, 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, thermoplastic resin used in injection molding such as polyethylene terephthalate, and thermosetting resin such as phenol resin, epoxy resin, silicone resin, unsaturated polyester, and the like.

The biasing mechanism 5 can bias the needle piece 11 radially inwardly or outwardly. The biasing mechanism 5 of this embodiment varies the biasing force that biases the needle piece 11 in the radial direction B according to the position of the needle member 2 in the axial direction A relative to the housing 4 .

As described above, FIG. 1A shows the needle member 2 in the standby position. Also, as mentioned above, FIG. 1B shows the needle member 2 in the insertion position. Here, the biasing force exerted by the biasing mechanism 5 on the needle piece 11 inward in the radial direction B is reduced as the needle member 2 moves from the standby position (see FIG. 1A) to the insertion position (see FIG. 1B). By doing so, the medical device 100 is less likely to get caught on the needle member 2 when the needle member 2 is pulled out of the body while the medical device 100 remains inside the body, compared to a configuration in which the needle member 2 moves from the standby position (see FIG. 1A) to the insertion position (see FIG. 1B) without reducing or changing the biasing force. Therefore, it becomes easier to place the medical device 100 at a desired depth in the living body.

In particular, the medical device 100, such as a tubular member or a sensor, which is implanted and left in the living body, preferably has a small diameter in order to reduce the burden such as pain of the person to be measured during the stay. Also, the needle member 2, which accommodates the medical device 100 in the accommodation space 12 and is inserted into the living body together with the medical device 100, preferably has a small diameter in order to reduce the pain of the subject during insertion. However, if the diameter of the medical device 100 and the needle member 2 is reduced and the gap between them becomes smaller, the medical device 100 is more likely to get caught on the inner surface of the needle member 2 when the needle member 2 is removed from the body while leaving the medical device 100 inside the body. Therefore, when the diameter of the medical device 100 and the needle member 2 is reduced to reduce the pain of the subject, it is preferable to use the biasing mechanism 5 that reduces the biasing force inward in the radial direction B after the needle member 2 moves from the waiting position (see FIG. 1A) to the insertion position (see FIG. 1B). As a result, even if the diameter of the medical device 100 and the needle member 2 are reduced, the medical device 100 is less likely to be caught by the needle member 2 when the needle member 2 is withdrawn from the living body.

More specifically, the biasing mechanism 5 of the present embodiment biases the needle piece 11 outward in the radial direction B when the needle member 2 is in the insertion position (see FIG. 1B). By doing so, it becomes more difficult for the medical device 100 to get caught on the needle member 2 when the needle member 2 is pulled out of the body while the medical device 100 remains inside the body. This is because the accommodation space 12 for the needle piece 11 is widened. In the present embodiment, the biasing mechanism 5 may or may not bias the needle piece 11 inward in the radial direction B when the needle member 2 is in the standby position (see FIG. 1A) and in the state between the standby position and the insertion position (see FIG. 1B). However, the biasing mechanism 5 preferably biases the needle piece 11 inward in the radial direction B when the needle member 2 is in the standby position (see FIG. 1A) and in a state between the standby position and the insertion position (see FIG. 1B). By doing so, it is difficult for the plurality of needle pieces 11 to move outward in the radial direction B during insertion. That is, when the needle member 2 is inserted into the living body, the needle member 2 is easily maintained in a small diameter state. Therefore, the pain of the person to be measured when inserting the needle member 2 can be further reduced.

The biasing mechanism 5 of the present embodiment is composed of the aforementioned pressing portion 31 provided in the housing 4 . The pressing portion 31 directly or indirectly engages the needle piece 11 when the needle member 2 moves from the standby position (see FIG. 1A) to the insertion position (see FIG. 1B). As a result, the pressing portion 31 presses the needle piece 11 outward in the radial direction B. As shown in FIG. More specifically, in the present embodiment, the pressing portion 31 formed of an inclined surface facing the outside in the radial direction B and the removal direction A2 slides on the end surface 25a of the engaging convex portion 25 formed of the inclined surface facing the inside in the radial direction B and the insertion direction A1, whereby the holding piece 21 including the engaging convex portion 25 is pressed outward in the radial direction B. As a result, the needle piece 11 is indirectly pushed outward in the radial direction B via the holding piece 21 .

The biasing mechanism 5 of the present embodiment is configured by the pressing portion 31 of the housing 4, but the configuration of the biasing mechanism 5 is not particularly limited. The biasing mechanism 5 may be configured, for example, to bias the needle piece 11 inward in the radial direction B when the needle member 2 is in the waiting position (see FIG. 1A), and not to bias the needle piece 11 inward and outward in the radial direction B when the needle member 2 is in the insertion position (see FIG. 1B). Details of such an urging mechanism will be described later (see FIGS. 3 to 6).

The operating member 7 of this embodiment is attached to the housing 4 . In this embodiment, by operating a part or all of the operation member 7 , the locking claw portion 26 of the holding piece 21 can be deformed and the hooking on the top wall portion 63 can be released. In the operation member 7 of the present embodiment, by pushing the side surface of the operation member 7 , the locking claw portion 26 is released from being caught on the top wall portion 63 . The shape of the operation member 7 is not particularly limited as long as it can release the hooking of the locking claw portion 26 on the top wall portion 63 .

The biasing member 8 of the present embodiment is elastically deformable in the axial direction A, and can move the needle member 2 from the waiting position (see FIG. 1A) to the insertion position (see FIG. 1B) by a restoring force. As in this embodiment, the biasing member 8 may be a coil spring arranged between the main body portion 22 of the holding piece 21 and the ceiling wall portion 63 of the housing 4 . In this embodiment, the coil spring as the biasing member 8 is elastically deformed between the main body 22 and the ceiling wall 63 when the locking claw 26 of the holding piece 21 is hooked on the ceiling wall 63 . When the locking claw portion 26 is released from the top wall portion 63, the needle member 2 moves from the standby position (see FIG. 1A) to the insertion position (see FIG. 1B) by the restoring force of the coil spring as the biasing member 8.

The biasing member 8 is not limited to the coil spring of this embodiment, and for example, an elastic member other than the coil spring may be used.

A sensor 100 a serving as the medical device 100 of this embodiment is a linear member that is housed in the housing space 12 of the needle member 2 . A member that detects an electrical signal corresponding to the amount or concentration of the substance to be measured can be used as the sensor 100a. The sensor 100 a extends along the axial direction A of the needle member 2 within the housing space 12 .

The sensor 100a as the medical device 100 may be, for example, a wire electrode with a circular cross-sectional shape. The outer diameter of the wire electrode can be, for example, 0.02 mm to 0.2 mm. The accommodation space 12 accommodates, for example, two wire electrodes, a working electrode and a reference electrode. The working electrode is configured based on a core material having a conductive surface, and may include a detection section configured to detect a substance to be measured on the outer wall of the core material, and a protection section in which the outer wall of the core material is coated with an insulating material. The detection unit can detect changes in the electrical properties of the substance to be measured. The detecting portion is formed on the surface of the core material using a thin film forming means such as dipping, electrolytic polymerization, or sputtering. A reagent that specifically reacts with the substance to be measured is applied to the surface of the working electrode. When the substance to be measured is glucose, a reagent containing glucose oxidase or a phenylboronic acid compound is used. The reference electrode is used as a reference electrode for the working electrode described above. A reference electrode and a counter electrode may be coiled around the working electrode to form a single wire electrode. Alternatively, three wire electrodes may be arranged within the accommodation space 12 . Each of the three wire electrodes may constitute a working electrode, a reference electrode and a counter electrode. Information on the substance to be measured detected by the detection unit of the working electrode is transmitted to the control device.

Next, a series of operations of the insertion device 1 for inserting and indwelling the sensor 100a as the medical device 100 into the living body and removing the needle member 2 from the living body by the insertion device 1 of the present embodiment will be described with reference to FIG. FIG. 2A shows a state in which the insertion device 1 is arranged on the surface of the living body BS before the needle member 2 and the medical device 100 are inserted into the living body. In Figure 2A, the needle member 2 of the insertion device 1 is in the standby position. FIG. 2B shows a state in which the insertion device 1 is operated to insert the needle member 2 and the medical device 100 into the living body. FIG. 2C shows a state in which the needle member 2 and the medical device 100 have advanced further in the insertion direction A1 from the state in FIG. 2B, and the needle member 2 has reached the deepest position in the living body. In other words, FIG. 2C shows the needle member 2 in the insertion position. FIG. 2D is a diagram showing how the sensor 100a as the medical device 100 is left inside the living body and the needle member 2 is removed outside the living body from the state shown in FIG. 2C.

As shown in FIG. 2A, the insertion device 1 brings the contact surface 62a of the housing 4 into contact with the living body surface BS when inserting the needle member 2 and the sensor 100a as the medical device 100 into the living body. In this state, an operator such as a medical worker operates the operating member 7 of the insertion device 1 . Thereby, as shown in FIG. 2B, the needle member 2 and the medical device 100 can be moved in the insertion direction A1. At this time, the holding member 6 holding the needle piece 11 constituting the needle member 2 also moves in the insertion direction A1. As shown in FIG. 2B, when the needle member 2 and the medical device 100 are inserted to a predetermined depth in the living body, the holding pieces 21 of the holding member 6 come into contact with the pressing portions 31 provided on the housing 4 and are pressed outward in the radial direction B. In other words, the plurality of holding pieces 21 of the holding member 6 constituting the fluctuation mechanism 3 are biased outward in the radial direction B by the action of the pressing portion 31 constituting the biasing mechanism 5 . Therefore, the needle piece 11 inserted into the living body held by the holding piece 21 presses the living tissue so as to spread outward in the radial direction B inside the living body. Then, when the needle member 2 and the medical device 100 reach the insertion position, the engaging projections 25 of the locking claws 23 of the holding pieces 21 fit into the engaging recesses 32 of the housing 4 as shown in FIG. 2C. Even in this fitted state, the needle piece 11 still presses the living tissue so as to expand outward in the radial direction B inside the living body. Therefore, in a state where the needle member 2 is in the insertion position, the living tissue is spread and slightly deformed, and a minute gap can be formed between the needle piece 11 and the medical device 100 . As a result, when the needle member 2 is withdrawn from the living body, the plurality of needle pieces 11 constituting the needle member 2 are less likely to be caught by the sensor 100a accommodated in the accommodation space 12. FIG. As a result, it becomes easier to place the medical device 100 at a desired depth in the living body.

Further, as shown in FIG. 2C, when the engaging projection 25 of the locking claw portion 23 of the holding piece 21 fits into the engaging recess 32 of the housing 4, the engaging projection 25 and the engaging recess 32 interfere with each other in the axial direction A. As shown in FIG. Specifically, when the holding piece 21 is moved in the removal direction A2, the surface of the engagement protrusion 25 of the holding piece 21 facing the removal direction A2 contacts the inner surface of the engagement recess 32 facing the insertion direction A1. Accordingly, when the holding piece 21 is moved in the removal direction A2, not only the holding piece 21 but also the housing 4 are moved in the removal direction A2. That is, in this embodiment, as shown in FIG. 2D, when the needle member 2 is withdrawn from the living body, the needle member 2, the housing 4, and the holding member 6 move together in the withdrawal direction A2, and the needle member 2 is withdrawn from the living body. The plurality of needle pieces 11 of the needle member 2 are removed from the living body while being spaced outward in the radial direction B compared to the state before insertion (see FIG. 2A).

In the present embodiment, when the needle member 2 is withdrawn from the living body, the housing 4 is moved in the withdrawal direction A2 together with the needle member 2 and the holding member 6. However, the housing may not be moved, and only the needle member and the holding member may be moved with respect to the housing to enable withdrawal (see FIGS. 3 to 6).

(Second embodiment)
Next, an insertion device 201 as a second embodiment will be described with reference to FIGS. 3A to 3C and FIGS. 4A to 4C. The insertion device 201 differs from the above-described insertion device 1 (see FIG. 1A, etc.) in the configurations of the variation mechanism and the biasing mechanism. This difference will be mainly described here.

3A-3C are schematic diagrams showing the oscillating mechanism 203 and the biasing mechanism 205 of the insertion device 201. FIG. FIG. 3A shows a state in which the needle member 202 is in the standby position before the medical device 100 is left in the living body. FIG. 3B shows the needle member 202 in the inserted position. FIG. 3C shows a state in which the needle member 202 has returned to the standby position after the medical device 100 has been left in the living body. FIG. 4A is a cross-sectional view taken along line I-I of FIG. 3A. FIG. 4B is a cross-sectional view taken along line II-II of FIG. 3B. FIG. 4C is a cross-sectional view along line III-III in FIG. 3C.

As shown in FIGS. 3A-3C and 4A-4C, the insertion device 201 includes a needle member 202, a variation mechanism 203, a housing 204, an urging mechanism 205, and a sensor 100a as the medical device 100. FIG.

Needle member 202 includes a plurality of needle pieces 211 . In other words, the plurality of needle pieces 211 of the present embodiment form one hollow needle when they are closest to the inner side in the radial direction B. As shown in FIG. A hollow needle formed by the plurality of needle pieces 211 has a tip end surface composed of one or more blade surfaces inclined with respect to the axial direction A. As shown in FIG. This tip surface is not closed even when the plurality of needle pieces 211 are closest to the inner side in the radial direction B. As shown in FIG. That is, regardless of the positions of the plurality of needle pieces 211 in the radial direction B, the distal end surface of the needle member 202 is provided with a distal opening.

The fluctuation mechanism 203 is realized by a gap 41 between the needle piece 211 and the housing 204 located outside in the radial direction B of the needle piece 211 .

The biasing mechanism 205 is composed of the deformation member 42, and the guide surface 43 and the recess 44 of the housing 204, which will be described later. As shown in FIGS. 3A to 3C and FIGS. 4A to 4C, the deformable member 42 can be deformed between a first configuration in which the needle piece 211 is pressed inward in the radial direction B and a second configuration in which the needle piece 211 is not pressed inward in the radial direction B. The deformation member 42 is arranged in the gap 41 described above. The deformation member 42 may be, for example, a diamond-shaped elastic frame shown in FIGS. 4A to 4C. A diamond-shaped elastic frame as the deformation member 42 can be elastically deformed so that two opposing vertexes approach or separate on a diagonal line. Therefore, the first form of the deformable member 42 in this embodiment means a form in which the elastic frames are compressed and elastically deformed such that the two opposing vertices of the elastic frame are closer to each other on the diagonal line than in the natural state. Further, the second form of the deformable member 42 in the present embodiment means a form in which two opposing vertices of the elastic frame are diagonally spaced apart from each other as compared with the first form.

As shown in FIGS. 3A and 4A, the inner surface of the housing 204 is provided with a guide surface 43 along which the deformation member 42 of the first form can slide in the axial direction A. As shown in FIGS. The deformation member 42 is positioned in the above-described gap 41 and is compressed and elastically deformed by being sandwiched between the opposing guide surfaces 43 . In this state, the needle piece 211 located inside the elastic frame is urged inward in the radial direction B by the inner surface of the elastic frame. Here, the static friction coefficient in the axial direction A between the guide surface 43 and the deformable member 42 of this embodiment is smaller than the static friction coefficient in the axial direction A between the needle piece 211 and the deformable member 42 . Therefore, when the needle member 202 is moved in the insertion direction A1 with respect to the housing 204, the deformation member 42 slides on the guide surface 43 and moves together with the needle member 202 in the insertion direction A1.

Further, the inner surface of the housing 204 is provided with a concave portion 44 recessed outward in the radial direction B from the guide surface 43 at a position adjacent to the guide surface 43 in the insertion direction A1. Therefore, when the needle member 202 and the deformable member 42 move in the insertion direction A1 from the state shown in FIGS. 3A and 4A and the deformable member 42 reaches the position shown in FIGS. In other words, the elastic frame of this embodiment expands so that the two opposing vertexes are separated from each other and enters the recess 44 . At that time, the deformation member 42 changes from the state of contact with the needle piece 211 to the state of being separated from the needle piece 211 . Therefore, the urging force exerted by the elastic frame as the deformation member 42 on the needle piece 211 inward in the radial direction B is released.

That is, according to the biasing mechanism 205 of the present embodiment, as with the biasing mechanism 5 of the first embodiment described above, the force of biasing the needle piece 211 inward in the radial direction B is reduced as the needle member 202 moves from the standby position (see FIGS. 3A and 4A) to the insertion position (see FIGS. 3B and 4B). However, the biasing mechanism 205 of the present embodiment does not bias the needle piece 211 either inwardly or outwardly in the radial direction B when the needle member 202 is in the insertion position (see FIGS. 3B and 4B). By releasing the pressing force acting on the needle piece 211 inward in the radial direction B, it is possible to prevent the needle member 202 from being caught by the medical device 100 when the needle member 202 is removed as shown in FIGS. 3C and 4C.

The deformation member 42 of the present embodiment is configured by a rhombus-shaped elastic frame, but the configuration of the deformation member 42 is not particularly limited, such as another polygonal elastic frame, for example. Furthermore, the deformable member 42 of this embodiment is composed of only a single member, but may be composed of a combination of a plurality of members. Such deformation member 42 will be described later (see FIGS. 5 and 6).

In addition, the housing 204 of the present embodiment includes the recess 44 as a space that allows the deformation member 42 to expand outward in the radial direction B due to the restoring force. Therefore, the recess 44 formed on the inner surface of the housing 204 can be appropriately designed according to the configuration of the deformation member 42 .

As shown in FIGS. 3C and 4C, when the needle member 202 is withdrawn from the living body, the deformable member 42 enters the concave portion 44 of the housing 204 and does not move together with the needle member 202 in the withdrawal direction A2. Therefore, the needle member 202 is withdrawn from the living body by moving in the withdrawal direction A2 with respect to the housing 204 and the deformable member 42 .

(Third Embodiment)
Next, an insertion device 301 as a third embodiment will be described with reference to FIGS. 5A to 5C and FIGS. 6A to 6C. The insertion device 301 differs from the above-described insertion device 201 (see FIG. 3A, etc.) in the configuration of the deformable member 42, but has other configurations in common. Here, this difference will be mainly described, and the description of the common configuration will be omitted.

5A-5C are schematic diagrams showing the variation mechanism 203 and the biasing mechanism 305 of the insertion device 301. FIG. FIG. 5A shows a state where the needle member 202 is in the waiting position before the medical device 100 is left in the living body. FIG. 5B shows the needle member 202 in the inserted position. FIG. 5C shows a state in which the needle member 202 is in the standby position after the medical device 100 has been left in the living body. FIG. 6A is a cross-sectional view taken along line IV-IV in FIG. 5A. FIG. 6B is a cross-sectional view along line V-V in FIG. 5B. FIG. 6C is a cross-sectional view along line VI-VI of FIG. 5C.

As shown in FIGS. 5A-5C and 6A-6C, the insertion device 301 includes a needle member 202, a variation mechanism 203, a housing 204, an urging mechanism 305, and a sensor 100a as the medical device 100. FIG.

The fluctuation mechanism 203 is realized by a gap 41 between the needle piece 211 and the housing 204 located outside in the radial direction B of the needle piece 211 .

The biasing mechanism 305 is composed of the deformation member 42 and the guide surface 43 and the recess 44 of the housing 204 . As shown in FIGS. 5A to 5C and FIGS. 6A to 6C, the deformable member 42 can be deformed between a first configuration in which the needle piece 211 is pressed inward in the radial direction B and a second configuration in which the needle piece 211 is not pressed inward in the radial direction B. The deformation member 42 is arranged in the gap 41 described above. The deformation member 42 is composed of, for example, a first moving body 51, a second moving body 52, and an elastic member 53, as shown in FIGS. 6A to 6C. The first moving body 51 and the second moving body 52 are positioned outside in the radial direction B of the needle member 202 . Also, the first moving body 51 and the second moving body 52 face each other in the radial direction B with the needle member 202 interposed therebetween. The elastic member 53 is located outside the needle member 202 in the radial direction B. As shown in FIG. In addition, the elastic member 53 can be elastically deformed between the first moving body 51 and the second moving body 52 in the facing direction of the first moving body 51 and the second moving body 52 . By elastically deforming the elastic member 53, the facing distance between the first moving body 51 and the second moving body 52 can be varied. The elastic member 53 is composed of, for example, a coil spring. The elastic member 53 of this embodiment is composed of two coil springs arranged on both sides of the needle member 202 in the radial direction B. As shown in FIG. The first form of the deformable member 42 in this embodiment means a form in which the elastic member 53 is compressed and elastically deformed so that the facing distance between the first moving body 51 and the second moving body 52 is reduced. Further, the second form of the deformable member 42 in the present embodiment means a form in which the facing distance between the first moving body 51 and the second moving body 52 is longer than in the first form.

As shown in FIGS. 5A and 6A, the inner surface of the housing 204 is provided with a guide surface 43 along which the deformation member 42 of the first form can slide in the axial direction A. As shown in FIGS. More specifically, the first moving body 51 and the second moving body 52 of the deformation member 42 slide on the guide surface 43 of the housing 204 in the axial direction A. As shown in FIG. The deformable member 42 is positioned in the above-described gap 41, and the first moving body 51 and the second moving body 52 are sandwiched between the guide surfaces 43 arranged to face each other. As a result, the two coil springs as the elastic members 53 interposed between the first moving body 51 and the second moving body 52 are elastically deformed. In this state, the needle piece 211 positioned between the two coil springs is sandwiched between the first moving body 51 and the second moving body 52 and is biased inward in the radial direction B. As shown in FIG. Here, the coefficient of static friction in the axial direction A between the guide surface 43 of the present embodiment and the first moving body 51 and the second moving body 52 is smaller than the coefficient of static friction in the axial direction A between the needle piece 211 and the first moving body 51 and the second moving body 52. Therefore, when the needle member 202 is moved in the insertion direction A1 with respect to the housing 204, the deformation member 42 including the first moving body 51 and the second moving body 52 slides on the guide surface 43 and moves together with the needle member 202 in the insertion direction A1.

Further, the inner surface of the housing 204 is provided with a concave portion 44 recessed outward in the radial direction B from the guide surface 43 at a position adjacent to the guide surface 43 in the insertion direction A1. The needle member 202 and the deformation member 42 move in the insertion direction A1 from the state shown in FIGS. 5A and 6A, and the deformation member 42 reaches the position shown in FIGS. 5B and 6B adjacent to the guide surface 43 in the insertion direction A1. At that time, the first moving body 51 and the second moving body 52 of the deformation member 42 are separated outward in the radial direction B by the restoring force of the coil spring as the elastic member 53 and enter the recess 44 . As a result, the first moving body 51 and the second moving body 52 of the deformable member 42 change from a state in which they are in contact with the needle piece 211 to a state in which they are not in contact with each other. Therefore, the urging force exerted by the first moving body 51 and the second moving body 52 of the deformation member 42 on the needle piece 211 inward in the radial direction B is released.

That is, according to the biasing mechanism 305 of the present embodiment, as with the biasing mechanism 205 of the second embodiment described above, the force of biasing the needle piece 211 inward in the radial direction B decreases as the needle member 202 moves from the standby position (see FIGS. 5A and 6A) to the insertion position (see FIGS. 5B and 6B). Furthermore, similar to the biasing mechanism 205 of the second embodiment described above, the biasing mechanism 305 of this embodiment does not bias the needle piece 211 inwardly or outwardly in the radial direction B when the needle member 202 is in the insertion position (see FIGS. 5B and 6B). By releasing the pressing force acting on the needle piece 211 inward in the radial direction B, it is possible to prevent the needle member 202 from being caught by the medical device 100 when the needle member 202 is removed as shown in FIGS. 5C and 6C.

As shown in FIGS. 5C and 6C, when the needle member 202 is withdrawn from the living body, the first moving body 51 and the second moving body 52 of the deformable member 42 enter the concave portion 44 of the housing 204 and do not move together with the needle member 202 in the withdrawal direction A2. Therefore, the needle member 202 is withdrawn from the living body by moving in the withdrawal direction A2 with respect to the housing 204 and the deformable member 42 .

Finally, with reference to FIGS. 7 and 8, an example of a manufacturing method of the needle unit configured by the needle piece 11 (see FIG. 1A etc.) and the holding piece 21 (see FIG. 1A etc.) shown in the first embodiment will be described. The method of manufacturing the needle unit shown in FIGS. 7 and 8 includes a punching step S1 for punching the deployable body 120 of the needle piece 11, a bending press step S2 (see FIG. 8) for pressing and bending the deployable body 120 by a press molding machine 500 to form the semi-tubular needle piece 11, and a joining step S3 for joining the needle piece 11 to the holding piece 21. The blade surface at the tip of the needle piece 11 may be formed in advance at the tip of the deployable body 120 in the punching step S<b>1 for forming the deployable body 120 . In addition, a blade surface forming step may be further included in which a blade surface is formed at the distal end of the semi-tubular needle piece 11 formed by the bending press step S2.

In the joining step S3, the needle piece 11 can be joined to the holding piece 21 (see FIG. 1A, etc.) by, for example, fusion bonding. Thus, the needle unit of the insertion device 1 composed of the needle piece 11 and the holding piece 21 is manufactured. In the first embodiment described above, two needle units are used. The method of manufacturing the needle unit may further include another step such as a step of polishing the needle piece 11 in addition to the steps described above.

The needle piece 11 of the first embodiment has a semi-tubular shape, and the development body 120 is pressed until it has a semi-tubular shape in the bending press step S2. However, the amount of bending of the deployable body 120 in the bending press step S2 is appropriately adjusted according to the shape of the needle piece 11 .

The insertion device and needle member according to the present disclosure are not limited to the configurations specifically shown in the above-described embodiments, and various modifications and changes are possible without departing from the scope of the claims.

The present disclosure relates to insertion devices and needle members.

1, 201, 301, 401: insertion device 2, 202: needle member 2a: insertion portion 2b: large diameter portion 3, 203: fluctuation mechanism 4, 204: housing 5, 205, 305: biasing mechanism 6: holding member 7: operation member 8: biasing members 11, 11a, 11b, 211: needle piece 12: housing space 21: holding piece 21a: first holding piece 21b: second holding piece 22 : Body portion 23: Locking claw portion 24: Extension portion 25: Engagement convex portion 25a: End surface 26 of the engagement projection: Locking claw portion 31: Pressing portion 32: Engagement concave portion 41: Gap 42: Deformable member 43: Guide surface 44: Concave portion 51: First moving body 52: Second moving body 53: Elastic member 61: Cylindrical portion 62: Base plate portion 62a: Contact surface 63: Ceiling wall portion 64: Through hole 65: Through hole 66: Main body Part 67: Projection 100: Medical device 120: Deployable body 500: Press molding machine A: Axial direction of needle member A1: Insertion direction A2: Withdrawal direction B: Radial direction of needle member C: Circumferential direction of needle member BS: Biological surface

Claims (5)

An insertion device for inserting a medical device into a living body,
a needle member defining a housing space capable of housing the medical device therein, and comprising a plurality of needle pieces to be inserted into a living body together with the medical device housed in the housing space;
a varying mechanism capable of moving the plurality of needle pieces toward or away from each other in the radial direction of the needle member and varying the cross-sectional area of the housing space in the radial direction ;
a housing for axially movably holding the needle member;
a biasing mechanism capable of biasing the needle piece radially inwardly or outwardly;
In the insertion device, the biasing mechanism changes the biasing force that biases the needle piece in the radial direction according to the axial position of the needle member with respect to the housing. the needle member is movable between a standby position housed in the housing and an insertion position protruding from the housing;
2. The insertion device according to claim 1 , wherein the biasing force exerted by the biasing mechanism on the needle piece inward in the radial direction is reduced as the needle member moves from the standby position to the insertion position. The biasing mechanism is
urging the needle piece inward in the radial direction in a state in which the needle member is at the standby position;
3. The insertion device according to claim 2 , wherein the needle piece is not urged inward in the radial direction when the needle member is in the insertion position. 3. The insertion device according to claim 2 , wherein the biasing mechanism biases the needle piece outward in the radial direction when the needle member is in the insertion position. 5. The insertion device according to claim 4 , wherein the biasing mechanism is provided in the housing and includes a pressing portion that presses the needle piece outward in the radial direction by directly or indirectly engaging with the needle piece when the needle member moves from the standby position to the insertion position.

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