JP7029310B2 - Puncture needle cartridge and its manufacturing method - Google Patents

Description

The present invention relates to, for example, a puncture needle cartridge for puncturing a human body with a needle to allow blood to flow out in order to measure a blood glucose level, and a puncture device to which the needle is mounted.

The puncture needle cartridge was attached to the puncture device, then the puncture needle cover portion was removed, and then the puncture operation was performed toward the puncture site.
That is, this type of puncture needle cartridge extends to the lancet body having a connection part to the puncture device on the rear end side, a puncture needle cover part on the front end side, and a break part in the middle part, and before and after the break part of the lancet body. It includes a puncture needle embedded in the lancet body and a lancet case provided on the outer periphery of these lancet bodies (for example, Patent Document 1 below).

Japanese Unexamined Patent Publication No. 2004-333440 International Publication No. 2007/129775 International Publication No. 2014/083783

In the above-mentioned conventional example, when the puncture needle cartridge is attached to the puncture device, the puncture device breaks the broken portion by rotating the rear side of the lancet main body constituting the puncture needle cartridge.

In such a configuration, since the puncture device is provided with a rotation mechanism for rotating the lancet body of the puncture needle cartridge, this rotation mechanism is appropriate depending on the state in which the puncture needle cartridge is attached to the puncture device. May not work. As a result, in the conventional configuration, there is a problem that the broken portion cannot be broken and the puncture needle cartridge cannot be properly attached to the puncture device.

Therefore, an object of the present invention is to appropriately attach the puncture needle cartridge to the puncture device.

In order to achieve this object, the puncture needle cartridge of the present invention is a puncture needle cartridge attached to a puncture device, and includes a columnar lancet body and a tubular lancet case. The columnar lancet body is provided on the puncture needle, the second end side opposite to the first end on which the puncture needle is punctured, and the connection portion connected to the puncture device, and the first end side. It is provided in the middle part between the first end and the second end of the puncture needle cover part that covers the tip part of the puncture needle before use, and is broken when puncturing, and the puncture needle cover part is separated. A broken portion that exposes the tip of the puncture needle, a guide protrusion provided on the first end side of the broken portion on the outer peripheral surface of the puncture needle cover portion, and a sliding protrusion provided on the second end side of the broken portion. And have. The tubular lancet case is formed from the first end side to the second end side, and when the guide protrusions are engaged and relatively move in the puncture direction, a spiral guide that applies a rotational force in a predetermined direction is applied. It has a portion and a sliding groove that guides movement in the puncture direction with the sliding protrusion engaged, and is mounted on the outer periphery of the middle portion of the lancet body in a state where the broken portion is not broken. The first part of the puncture needle cover part on the first end side from the broken part is formed of the first resin material. The second part of the lancet body, which holds the puncture needle and has a connection portion on the second end side of the broken portion of the lancet body, is formed of a second resin material different from the first resin material. The first part and the second part are joined in the vicinity of the broken part.

According to the puncture needle cartridge of the present disclosure, the puncture needle cartridge can be appropriately attached to the puncture device.

The perspective view which shows the use state of the puncture needle cartridge which concerns on Embodiment 1 of this invention. An exploded perspective view of the puncture needle cartridge of FIG. 1. The perspective view of the puncture needle cartridge of FIG. The perspective view of the puncture needle cartridge of FIG. (A) is a cross-sectional view of the puncture needle cartridge of FIG. 1 from the A side of FIG. (B) is a development view of a main part of the puncture needle cartridge of FIG. An exploded perspective view of a puncture device to which the puncture needle cartridge of FIG. 1 is attached. FIG. 6 is a cross-sectional view of the piercing device of FIG. FIG. 6 is a cross-sectional view of the piercing device of FIG. FIG. 6 is a cross-sectional view of the piercing device of FIG. FIG. 6 is a cross-sectional view of the piercing device of FIG. FIG. 6 is a cross-sectional view of the piercing device of FIG. FIG. 6 is a cross-sectional view of the piercing device of FIG. FIG. 6 is a cross-sectional view of the piercing device of FIG. FIG. 6 is a cross-sectional view of the piercing device of FIG. The perspective view of the puncture needle cartridge of FIG. (A), (b), (c) are diagrams showing the usage state of the puncture needle cartridge according to the first embodiment of the present invention. (A) is a perspective view of the puncture needle cartridge according to the first embodiment of the present invention. (B) is a side view thereof. An exploded perspective view of the puncture needle cartridge shown in FIG. 17A and the like. The figure which manufactures the puncture needle cartridge which concerns on another Embodiment 2 of this invention. The figure which shows the puncture needle of FIG. 19 and the lancet main body. The figure which manufactures the puncture needle cartridge of FIG. FIG. 21 is a cross-sectional view of the puncture needle cartridge of FIG. FIG. 21 is a cross-sectional view of the puncture needle cartridge of FIG. FIG. 21 is a cross-sectional view of the puncture needle cartridge of FIG.

Hereinafter, embodiments will be described in detail with reference to the drawings as appropriate. However, more detailed explanation than necessary may be omitted. For example, detailed explanations of already well-known matters and duplicate explanations for substantially the same configuration may be omitted.

This is to avoid unnecessary redundancy of the following description and to facilitate the understanding of those skilled in the art.
It should be noted that the inventor intends to limit the subject matter described in the claims by those skilled in the art by providing the accompanying drawings and the following description in order to fully understand the present disclosure. do not have.
Hereinafter, an embodiment of the present invention will be described.

(Embodiment 1)
FIG. 1 shows the piercing device 1. Then, the puncture device 1 punctures the human body with a needle and causes blood to flow out, for example, in order to measure the blood glucose level. The puncture device 1 punctures with the puncture needle cartridge 4 shown in FIGS. 2 and 3 attached to the front end opening 3 of the long cylindrical main body case 2.

In the following description, "front" means the side where puncture is performed by the puncture needle 10 (first end side), and "rear" means the opposite side (second end side). It shall be.
First, the basic configuration and operation of the puncture needle cartridge 4 will be described.

FIG. 2 is an exploded perspective view of the puncture needle cartridge 4 in the present embodiment. The puncture needle cartridge 4 has a resin-made, substantially cylindrical lancet body 5, and a resin-made, substantially cylindrical lancet case 6.

The lancet main body 5 has a connection portion 7 connected to the puncture device 1 provided on the rear end side (second end side), a substantially columnar puncture needle cover portion 8 provided on the front end side, and front and rear ends. It has a broken portion 9 provided between the two. Then, the puncture needle 10 (see FIG. 5) is embedded along the front-rear direction of the broken portion 9. The puncture needle cover portion 8 is provided with a disk-shaped base portion 11 at the end portion on the front end side (first end side) thereof. The base portion 11 has a surface substantially orthogonal to the puncture direction, and as shown in FIG. 3, the puncture needle cartridge 4 can be upright with the connection portion 7 facing upward.

Returning to FIG. 2, the puncture needle cover portion 8 on the front end side of the fractured portion 9 is provided with two guide protrusions 12 projecting in the outer peripheral direction in an axially symmetrical manner. Two elongated sliding projections 13 projecting toward the outer peripheral direction are provided on the rear end side of the fractured portion 9 in an axially symmetric manner.

The lancet case 6 is formed with two spiral guide portions 14 (broken line portion in FIG. 2) from the front end side to the rear end side on the inner surface side thereof.
The spiral guide portion 14 slides on the guide protrusion 12 of the lancet main body 5 toward the front end side, so that the lancet case 6 obtains a rotational force in a predetermined rotational direction.

Here, the predetermined rotation direction means that the guide portion 14 slides on the guide protrusion 12 toward the front end side, that is, the lancet case 6 moves relative to the lancet main body 5 along the puncture direction. In conjunction with this, the lancet case 6 is in the direction of rotation.

In the present embodiment, the rotation direction is, for example, a clockwise direction when the lancet main body 5 is viewed from the base portion 11 side as shown in the C direction of FIG. 2 (hereinafter, a predetermined rotation direction is referred to as a clockwise direction). Call).

The two guide protrusions 12 slide on a predetermined guide protrusion 12 corresponding to each of the two guide protrusions 12.
Therefore, although the details will be described later, when the lancet case 6 moves toward the base portion 11 at the front end, the lancet case 6 rotates clockwise around the lancet main body 5.

The lancet case 6 has two sliding grooves 15 that guide the sliding projection 13 of the lancet main body 5 to the rear end side. The sliding protrusion 13 slides back and forth in the engaged sliding groove 15 along the puncture direction.

FIG. 3 is a perspective view of an unused puncture needle cartridge 4. In the unused puncture needle cartridge 4, the broken portion 9 in which the puncture needle 10 is embedded is not broken (see FIG. 5).
The lancet case 6 is attached to the outer periphery of the intermediate portion 5a of the lancet main body 5 in a state where the broken portion 9 is not broken. The central axis of the cylindrical lancet body 5 coincides with the central axis of the tubular lancet case 6.

FIG. 4 is a view of the puncture needle cartridge in the state of FIG. 3 viewed from diagonally above.
FIG. 5A is a cross-sectional view taken along the plane A of FIG.
As shown in FIG. 5A, the lancet case 6 is mounted on the outer periphery of the intermediate portion 5a of the lancet main body 5. From the front end of the lancet case 6 to the base portion 11, a space 16 for moving the lancet case 6 to the base portion 11 side is formed.

FIG. 5B is a developed view of the inside of the lancet case 6, showing the engagement state between the spiral guide portion 14 and the guide protrusion 12.
In the lancet case 6, the front end side of the guide portion 14 is in contact with the guide protrusion 12 of the puncture needle cover portion 8 at the sliding start position P1.

In order to form this state, the puncture needle cartridge 4 is manufactured by the following manufacturing process.
First, the lancet case 6 is inserted into the lancet main body 5 and pushed down until the guide portion 14 on the inner surface side comes into contact with the guide protrusion 12.

Further, when the lancet case 6 is pushed down, the lancet case 6 rotates by the spiral guide portion 14 sliding toward the front end side along the guide protrusion 12. When the lancet case 6 is rotated up to, for example, 30 degrees, twisting (elastic twisting that does not lead to breaking) occurs at the broken portion 9.

After that, when the lancet case 6 is released, the restoring force of the broken portion 9 causes the lancet case 6 to rotate in the reverse direction and is likely to be pushed up, but the tip of the sliding protrusion 13 presses the lancet case 6 with the receiving portion 17.

Therefore, due to the elasticity of the sliding protrusion 13, the front end side of the guide portion 14 stands still in contact with the guide protrusion 12 at the sliding start position P1. That is, at the sliding start position P1, the lancet case 6 is mounted on the outer periphery of the intermediate portion 5a of the lancet main body 5.

At the time of use, the puncture needle cartridge 4 is inserted into the puncture device 1 as shown in FIG. At this time, since the tip of the piercing device 1 comes into contact with the receiving portion 17 of the lancet case 6, the lancet case 6 is pushed by the piercing device 1 and is pushed from the sliding start position P1 (intermediate portion 5a of the lancet body 5) to the front end. Moves (slides) to the base 11 side of the.

When the lancet case 6 slides toward the front end side, the lancet case 6 rotates clockwise along the spiral guide portion 14.
Specifically, when the lancet case 6 slides toward the front end side, as shown in FIG. 5 (b), the guide portion 14 moves from the sliding start position P1 to the front end side (FIG. 5 (b) in the lancet case 6. ) Slides in the B direction) and slides on the guide protrusion 12 up to the sliding end position P2.

When the spiral guide portion 14 slides along the guide protrusion 12, the lancet case 6 receives a rotational force in a predetermined direction (for example, clockwise) and rotates clockwise. Then, the lancet case 6 slides toward the base portion 11 on the front end side while rotating.

The rotating lancet case 6 rotates a portion of the lancet body 5 on the rear end side of the broken portion 9 in the C direction (clockwise) shown in FIG. 2 via the sliding groove 15 and the sliding protrusion 13.

On the other hand, the portion of the lancet main body 5 on the front end side of the broken portion 9 rotates counterclockwise (in the D direction in FIG. 2) via the guide protrusion 12 due to the reaction force from the spiral guide portion 14.
As a result, a rotational force in the opposite direction is generated at the connecting portions before and after the broken portion 9, and the broken portion 9 can be broken.

That is, when the lancet case 6 mounted on the outer periphery of the intermediate portion 5a slides toward the base portion 11 provided at the front end along with the operation of mounting the puncture needle cartridge 4 on the front end portion of the puncturing device 1, it breaks. A rotational force in the opposite direction is applied to the front and rear portions of the portion 9. That is, the puncture needle cartridge 4 itself has a rotation mechanism that breaks the puncture needle cover portion 8 from the puncture needle cartridge 4 at the break portion 9.

Therefore, the broken portion 9 can be broken without being affected by the state in which the puncture needle cartridge 4 is attached to the puncturing device 1.
As a result, the puncture needle cartridge 4 can be appropriately attached to the puncture device 1.

FIG. 6 is an exploded perspective view of the puncture device 1 to which the puncture needle cartridge 4 is mounted.
The piercing device 1 includes a tubular main body case 2 having a front end opening 3, a grip portion 18, and a rear end opening 19. A main rod 20 is provided in the main body case 2. An injection rod 22 having a lancet holder 21 is slidably mounted on the main rod 20 in the front-rear direction.

The main body case 2 is provided with a main spring (an example of an urging body) 23 for urging the injection rod 22 toward the front end side, and an operation button 24 at the rear. Further, the front end opening 3 is provided with a tubular bush 25 into which the puncture needle cartridge 4 is inserted.

When the puncture needle cartridge 4 is attached to the puncture device 1, as shown in FIG. 7, the connection portion 7 of the puncture needle cartridge 4 is pushed into the front end opening 3 of the puncture device 1. The connection portion 7 abuts on the front end of the lancet holder 21 as shown in FIG. 8 and is attached to the lancet holder 21 as shown in FIG. As a result, the puncture needle cartridge 4 is attached to the puncture device 1.

When the base portion 11 is pushed from the state of FIG. 8 to the state of FIG. 9 toward the lancet case 6, the lancet case 6 slides toward the base portion 11 and rotates clockwise as described above. The broken portion 9 is broken by rotating to. Then, when the user pulls the base portion 11, as shown in FIG. 10, the puncture needle cover portion 8 covering the tip of the puncture needle 10 is easily removed.

On the other hand, in the piercing device 1 of FIG. 9, the lancet main body 5 pushes the lancet holder 21 and the injection rod 22 toward the rear end side. As a result, the main spring 23 is pulled toward the rear end side via the puncture cam 26, and the puncture force is stored.

As shown in FIG. 10, this puncture force is maintained by engaging the lock claw 27 of the injection rod 22 and the engaging claw 29 of the lock body 28 on the rear end side of the main body case 2.
After that, when the user presses the operation button 24, the operating body 30 at the front end of the operation button 24 pushes up the extrusion claw 31 as shown in FIG. As a result, the lock body 28 rotates, and the engagement between the lock claw 27 and the engagement claw 29 (see FIG. 10) is released.

Then, the injection rod 22 is fired by the urging force of the main spring 23, the puncture needle 10 is ejected from the front end of the puncture needle cartridge 4, and the puncture operation is performed.
Then, as shown in FIG. 12, the injection rod 22 is pulled to a fixed position by the main spring 23, and the puncture needle 10 is pulled back into the lancet case 6.

After that, when the user presses the operation button 24, as shown in FIG. 13, the holder insertion cylinder 32 at the front end of the main rod 20 pushes the lancet case 6 via the operation body 30 and the lock body 28.

Then, as shown in FIG. 14, the connection portion 7 of the puncture needle cartridge 4 is disconnected from the lancet holder 21, and the puncture needle cartridge 4 is discharged from the puncture device 1.
That is, the lock body 28 switches between the puncture operation of the puncture needle cartridge 4 and the discharge operation of the puncture needle cartridge 4 by operating the operation button 24.

In actual use, as shown in FIG. 16A, the puncture needle cartridge 4 can be attached to the puncture device 1 simply by the user grasping the puncture device 1 and pushing it down to the upright puncture needle cartridge 4. ..

After that, as shown in FIG. 16B, when the user presses the operation button 24 while holding the puncture device 1 without changing the puncture device 1, the puncture needle 10 performs the puncture operation.
Then, as shown in FIG. 16C, when the user presses the operation button 24 again as it is, the operation target of the operation button 24 is switched from the puncture operation to the disposal operation by the lock body 28, so that the puncture needle is used. The disposal operation of the cartridge 4 is performed.

That is, the user can perform the mounting operation, the puncturing operation, and the disposal operation without changing the holding of the puncturing device 1 while holding it for the first time, which is highly convenient.
In the above description, the basic configuration and operation of the puncture needle cartridge 4 have been described.

In the present embodiment, in the puncture needle cartridge 4 shown in FIG. 3, as described above, the lancet case 6 slides from the intermediate portion 5a of the lancet main body 5 toward the front end side to operate the rotation mechanism and lancet. The case 6 is rotated in a predetermined rotation direction (for example, clockwise).

However, in actual use, the user may accidentally twist the lancet case 6 counterclockwise while handling the puncture needle cartridge 4.
At this time, since the lancet case 6 is only stopped on the outer periphery of the intermediate portion 5a of the lancet main body 5 due to the elasticity of the sliding protrusion 13, the lancet case 6 is turned counterclockwise due to the twisting force of the user. , The lancet case 6 may slide toward the rear end side (that is, the side opposite to the base portion 11).

Then, inside the lancet case 6, the guide portion 14 is disengaged from the predetermined guide protrusion 12 (the guide portion 14 and the predetermined guide protrusion 12 are disengaged), and the rotation mechanism does not operate normally. There is a risk.

That is, when the lancet case 6 slides toward the rear end side, as shown in FIG. 5 (b), inside the lancet case 6, the guide portion 14 moves from the sliding start position P1 to the rear end side (in the B direction). Slide in the opposite direction). Then, the guide portion 14 comes off from the predetermined guide protrusion 12.

In this state, even if the operation of pushing the puncture needle cartridge 4 into the tip of the puncture device 1 is performed, the guide portion 14 cannot slide on the predetermined guide protrusion 12 from the sliding start position P1 to the sliding end position P2. .. Therefore, the lancet case 6 cannot be rotated, and as a result, the broken portion 9 is not properly broken.

Therefore, in the puncture needle cartridge 4 of the present embodiment, as shown in FIGS. 3 and 4, the lancet case 6 is attached to the outer periphery of the intermediate portion 5a of the lancet main body 5 and is attached to the puncture needle cover portion 8. A pair of stoppers 33 (see FIGS. 15 and 18) are provided to prevent the lancet case 6 from sliding from the intermediate portion 5a (sliding start position P1) to the rear end side.

The stopper 33 is in contact with the lancet case 6 so as to sandwich the outer peripheral surface of the front end portion of the lancet case 6 from the outside.
On the other hand, the lancet case 6 is provided with two engaging claws 34 (see FIG. 18) protruding outward on the outer peripheral surface of the front end portion formed in the shape of a disk. Two engaging claws 34 are provided at positions corresponding to the stopper 33.

Then, in order to restrict the lancet case 6 from sliding toward the rear end side with respect to the lancet main body 5, the stopper 33 is brought into contact with the engaging claw 34 (the stopper 33 and the engaging claw 34 are engaged with each other). The lancet case 6 is prevented from rotating in the counterclockwise direction.

Therefore, the lancet case 6 rotates only in the clockwise direction (predetermined rotation direction).
As a result, by preventing the lancet case 6 from rotating in the counterclockwise direction, it is possible to regulate the sliding of the lancet case 6 toward the rear end side.

Therefore, the lancet case 6 slides only on the front end side with the position (initial position) where the stopper 33 and the engaging claw 34 come into contact as a base point.
Therefore, even if the user accidentally twists the lancet case 6 in the direction opposite to the predetermined rotation direction (counterclockwise direction), the stopper 33 makes the lancet case 6 counterclockwise. Rotation is regulated. Therefore, sliding of the lancet case 6 toward the rear end side can be restricted.

That is, the lancet case 6 can be slid only from the initial position to the front end side by the stopper 33. Therefore, on the inner peripheral surface side of the lancet case 6, it is possible to prevent the guide portion 14 and the guide protrusion 12 from being disengaged from each other, and to operate the rotation mechanism appropriately.

As a result, the puncture needle cartridge 4 can be appropriately attached to the puncture device 1.
The force for preventing the stopper 33 from sliding toward the rear end side of the lancet case 6 is much larger than the force with which the sliding protrusion 13 presses the lancet case 6. Therefore, it is possible to appropriately prevent the lancet case 6 from sliding toward the rear end side.

Further, in the present embodiment, as shown in FIG. 18, the engaging claw 34 is provided on the outer peripheral portion farthest from the central axis of the lancet case 6. Then, when the engaging claw 34 and the stopper 33 come into contact with each other, the stopper 33 and the engaging claw 34 can be brought into contact with each other on the outermost peripheral side of the lancet case 6.

Specifically, as shown in FIG. 3, a pair of disc-shaped base portions 11 extend toward the rear end side (upper side in FIG. 3) along the puncture direction on the outer peripheral portion thereof. An outer peripheral wall 35 is provided.

As shown in FIG. 4, the outer peripheral wall 35 is formed in an arc shape along the outer circumference, and is provided symmetrically with respect to the central axis of the puncture needle cover portion 8. The outer peripheral wall 35 extends to the outer periphery of the front end portion of the lancet case 6 mounted on the outer periphery of the intermediate portion 5a of the lancet main body 5. A stopper 33 is provided on the inner peripheral side of the pair of outer peripheral walls 35, respectively. The stoppers 33 are provided at equal intervals with respect to the outer circumference of the lancet case 6.

Therefore, even if the user accidentally holds the lancet case 6 and twists it counterclockwise, the stopper 33 is in contact with the engaging claw 34 at the outer peripheral portion farthest from the central axis of the lancet case 6. Therefore, the rotation of the lancet case 6 in the counterclockwise direction can be easily prevented. That is, it is possible to prevent the lancet case 6 from sliding toward the rear end side in the puncture direction.

In the present embodiment, when the lancet case 6 slides toward the front end side in the puncture direction, the guide portion 14 slides toward the front end side while rotating along the guide protrusion 12, so that the lancet case 6 becomes a watch. Obtain the rotational force around. However, the present invention is not limited to this.

For example, the lancet case 6 may be configured to obtain a counterclockwise rotational force opposite to clockwise by sliding the guide portion 14 on the guide protrusion 12 toward the front end side.
Further, in the present embodiment, as shown in FIG. 15, the guide protrusion 12 provided on the puncture needle cover portion 8 guides the spiral guide portion 14 (see FIG. 2) of the lancet case 6. have. Silicone oil is applied (applied) to the guide surface 36 as an example of the lubricating oil.

Therefore, when the lancet case 6 slides toward the front end side from the state of FIG. 5A, the guide portion 14 slides in the lancet case 6 as shown in FIG. 5B as described above. It slides from the motion start position P1 toward the front end side (direction B in FIG. 5B). Then, the guide portion 14 slides on the guide surface 36 of the guide protrusion 12 up to the sliding end position P2.

At this time, since the guide surface 36 is coated with silicone oil, the frictional force generated between the guide portion 14 and the guide surface 36 can be reduced, and the lancet case 6 can be slid with a small force. ..
As a result, the broken portion 9 can be broken with a small force.

The silicone oil applied to the guide surface 36 is a biocompatible oil and is harmless even if it adheres to or is absorbed by the human body.
Further, in order to perform the above operation, it is necessary to appropriately apply silicone oil to the guide surface 36 at the time of manufacturing. At this time, for example, if the amount of applied silicone oil is too large, the silicone oil may drip from the guide surface 36 and flow out to the outer surface of the puncture needle cartridge 4. Then, the silicone oil adheres to the user's finger during use, which causes discomfort to the user.

Therefore, at the time of manufacturing, as shown in FIG. 15, first, silicon oil is sprayed on the guide surface 36 using the nozzle 37. Next, before the silicone oil drips from the guide surface 36, air is blown onto the guide surface 36 using an air nozzle (not shown).

As a result, excess oil is blown off from the guide surface 36, and the guide surface 36 is thinly covered with the silicon oil, so that the silicon oil does not flow out from the guide surface 36.
As a result, it is possible to prevent the silicone oil from flowing out to the outer surface of the puncture needle cartridge 4 and prevent the user from being uncomfortable.

Further, in order to prevent the silicone oil from flowing out to the outer surface of the puncture needle cover portion 8, as shown in FIG. 15, the puncture needle cover portion 8 has a reservoir 38 that holds the silicone oil that has flowed out from the guide surface 36. May be provided.

Specifically, the lancet main body 5 is provided with a base portion 11 having a surface substantially orthogonal to the puncture direction on the front end side of the puncture needle cover portion 8. On the surface of the base portion 11 on the puncture needle cover portion 8 side, a reservoir portion 38 as a recess is formed in a ring shape so as to surround the puncture needle cover portion 8.

Therefore, even if the silicon oil flows out from the guide surface 36 as a result of spraying the silicon oil on the guide surface 36 at the time of manufacturing, the silicon oil that has flowed out is received and held by the reservoir 38. Can be done.
As a result, it is possible to prevent the silicone oil from flowing out to the outer surface of the puncture needle cartridge 4, so that it is possible to prevent the user from being uncomfortable.

As shown in FIG. 15, a plurality of ribs 39 are provided radially from the central axis of the puncture needle cover portion 8 inside the reservoir 38. Therefore, since the silicone oil can be stored in the reservoir 38 finely divided by the rib 39, the reservoir 38 can appropriately hold the silicone oil.

Further, in order to prevent the silicone oil from flowing out to the outer surface of the puncture needle cartridge 4, the silicone oil may be held on the outer periphery of the broken portion 9.
That is, the outer diameter of the broken portion 9 of the lancet main body 5 is formed to be smaller (weaker) than the outer diameter of the puncture needle cover portion 8 in order to ensure the break. That is, a recess for reducing the outer diameter is formed on the outer periphery of the broken portion 9. Therefore, it may be configured to hold the silicone oil in this recess.

More specifically, at the time of manufacturing, silicone oil is sprayed onto the guide surface 36 using the nozzle 37 with the base portion 11 facing up (upside down in FIG. 15). At this time, even if the silicon oil flows out from the guide surface 36, the silicon oil that has flowed out can be received and held by the concave portion of the fractured portion 9.

As a result, it is possible to prevent the silicone oil from flowing out to the outer surface of the puncture needle cartridge 4, so that it is possible to prevent the user from being uncomfortable.
The puncture needle 10 is previously provided with the same silicone oil as the silicone oil given to the guide surface 36 as lubricating oil. Therefore, even if the silicon oil held in the broken portion 9 adheres to the puncture needle 10 when the puncture needle cover portion 8 is removed from the puncture needle 10, it is harmless even if it adheres to or is absorbed by the human body. Therefore, it is possible to prevent an inappropriate state from occurring.

Here, when the puncture needle cartridge 4 manufactured as described above is used, in actual use, the user picks up the base portion 11 of the puncture needle cartridge 4 and attaches the puncture needle cartridge 4 to the puncture device 1. There are times. At this time, the user may mistakenly insert the puncture needle cartridge 4 into the puncture device 1 at an angle.

Then, from the state shown in FIG. 1, for example, when the rear end portion of the lancet case 6 diagonally contacts the front end opening 3 of the lancet device 1, an oblique force is applied to the rear end portion of the lancet body 5 via the lancet case 6. Is added. At this time, in the lancet case 6 shown in FIG. 5, the lancet main body 5 may be bent at the broken portion 9. As a result, the guide portion 14 may come off from the guide protrusion 12, and the rotation mechanism may not operate.

Therefore, in the puncture needle cartridge 4 of the present embodiment, as shown in FIGS. 3 and 4, a support portion (stopper 33 and an outer peripheral wall) that supports the outer periphery of the lancet case 6 is attached to the base portion 11 of the puncture needle cover portion 8. 35) is provided. That is, the support portion is composed of the stopper 33 of the puncture needle cover portion 8 and the outer peripheral wall 35.

Specifically, the outer peripheral wall 35 and the pair of stoppers 33 provided on the outer peripheral wall 35 abut on the outer periphery of the front end portion of the lancet case 6 and support the outer peripheral surface of the lancet case 6 so as to be sandwiched from the opposite side. ing.

Therefore, as shown in FIG. 3, the lancet case 6, the stopper 33, the outer peripheral wall 35, and the base portion 11 are integrated. That is, a state in which the outer peripheral portion of the puncture needle cartridge 4 is integrated is formed.

Therefore, even if the puncture needle cartridge 4 is inserted diagonally into the puncture device 1, the outer peripheral portion of the puncture needle cartridge 4 is held by the support portion, so that the lancet main body 5 in the lancet case 6 is protected. Can be done. Therefore, it is possible to prevent the lancet main body 5 from bending at the broken portion 9.

As a result, the guide portion 14 can be prevented from coming off from the guide protrusion 12, and the rotation mechanism can be operated appropriately. Therefore, the puncture needle cartridge 4 can be appropriately attached to the puncture device 1.

As described above, the stopper 33 of the present embodiment prevents the lancet case 6 from rotating in the direction opposite to the predetermined rotation direction, so that the lancet case 6 slides from the intermediate portion 5a to the rear end side. In addition to preventing this, the lancet case 6 is further supported from the outer peripheral surface side.

Here, as shown in FIGS. 17 (a) and 17 (b), in the outer peripheral wall 35 of the puncture needle cover portion 8, the end portion on the rear end side (upper side in FIG. 17) is circular toward the outside. A finger rest portion (first posture holding portion) 40 protruding in an arc shape may be provided.

In this configuration, when the user picks the outer peripheral wall 35 of the puncture needle cover portion 8 with a finger, the picked finger hits the finger contact portion 40 on the rear end side of the outer peripheral wall 35. The puncture needle cartridge 4 can be pushed into the puncture device 1.

Then, at this time, when the user picks the outer peripheral wall 35, the picking force of the user is transmitted to the lancet case 6 via the stopper 33 provided on the inner peripheral surface side of the outer peripheral wall 35. That is, since the user indirectly picks up the lancet case 6, the lancet case 6 can be stably supported.

As a result, the user can attach the puncture needle cartridge 4 to the puncture device 1 with the lancet case 6 indirectly picked up.
Further, the outer peripheral surface of the outer peripheral wall 35 may be provided with a plurality of non-slip 41s that are projected outward in an arc shape so that the user can pick them up with their fingers.

In this configuration, the user can see the non-slip 41 and pick the outer peripheral surface of the outer peripheral wall 35 by a natural operation. Further, the unevenness of the non-slip 41 makes it possible to firmly pinch the outer peripheral wall 35.

Further, on the front end side surface (lower side of FIG. 17B) of the base portion 11, a finger contact portion (second posture holding portion) having a plurality of convex portions 42 protruding toward the front end side (puncture side). 43 may be formed.
In this configuration, when the puncture needle cover portion 8 is picked and attached to the puncture device 1, the user puts his / her finger on the finger contact portion 43 provided on the front end surface at the end of the attachment operation, and the puncture needle cartridge 4 Can be pushed into the puncture device 1.
As a result, the puncture needle cartridge 4 can be appropriately attached to the puncture device 1.

As described above, the puncture needle cartridge 4 of the present embodiment includes a lancet main body 5 and a cylindrical lancet case 6 mounted on the outer periphery of the lancet main body 5. The lancet main body 5 has a puncture needle 10 embedded in the break portion 9 of the lancet main body 5 in the puncture direction, a guide protrusion 12 provided on the puncture needle cover portion 8 on the front end side of the break portion 9, and a rear of the break portion 9. It has a sliding protrusion 13 provided on the end side. The lancet case 6 is formed from the front end side to the rear end side, and has a spiral guide portion 14 in which the lancet case 6 obtains a rotational force by a guide protrusion 12, and a sliding groove 15 for guiding the sliding protrusion 13. ,have. The lancet case 6 is attached to the outer periphery of the intermediate portion 5a of the lancet main body 5 in a state where the broken portion 9 is not broken.

That is, when the lancet case 6 mounted on the outer periphery of the intermediate portion 5a is slid toward the front end side in accordance with the operation of mounting the puncture needle cartridge 4 on the puncturing device 1, the front end side and the rear end side of the broken portion 9 are slid. Rotational forces are applied to the portions in opposite directions. That is, the puncture needle cartridge 4 itself has a rotation mechanism for breaking the broken portion 9. Therefore, the rotation mechanism can be operated to stably break the broken portion 9 without being affected by the state in which the puncture needle cartridge 4 is attached to the puncturing device 1.

Then, in the present embodiment, in order to properly operate the rotation mechanism, the puncture needle cover portion 8 is slid (rotated counterclockwise) from the intermediate portion 5a of the lancet case 6 to the rear end side. A stopper 33 for regulating is provided.

Therefore, since the lancet case 6 slides only from the intermediate portion 5a to the front end side, the lancet case 6 rotates only in a predetermined direction. Therefore, the rotating mechanism can be appropriately operated to stably break the broken portion 9.

(Embodiment 2)
In the first embodiment, in the description using FIG. 15, by applying silicone oil to the guide surface 36, the frictional force generated between the guide portion 14 and the guide surface 36 is reduced, and the lancet case 6 is provided. The technique of sliding with a small force was explained.

In the present embodiment, in order to properly attach the puncture needle cartridge 4 to the puncture device 1 without applying silicon oil, the puncture needle cover portion 8 and the lancet main body 5 are appropriately broken at the break portion 9. The configuration will be described.

In the case of applying the silicone oil described with reference to FIG. 15, as shown in FIG. 19, for example, the puncture needle cartridge is filled with a resin material (polyethylene as an example) from the gate a corresponding to the puncture needle cover portion 8. 4 can be manufactured.

In this case, as described with reference to FIG. 15, by applying (applying) silicon oil to the guide surface 36, between the guide surface 36 of the puncture needle cover portion 8 and the lancet case 6 (guide portion 14). The frictional force generated in the lancet case 6 can be reduced and the lancet case 6 can be slid with a small force to be appropriately broken at the broken portion 9.

However, a configuration in which the same effect can be obtained by devising the material of the lancet main body 5 other than applying (applying) silicone oil to the guide surface 36 will be specifically described below.

That is, in the present embodiment, the resin material (first resin material) on the puncture needle cover portion 8 side of the break portion 9 having the guide surface 36 and the resin material of the portion on the connection portion 7 side of the break portion 9. It can be realized by a configuration that makes (the second resin material) different from each other.

Specifically, polyethylene having a low coefficient of friction (as an example, low-density polyethylene containing fatty acid amide is added at 0.1 to 1.0 wt /% as the first resin material to the resin material on the piercing needle cover portion 8 side. ) Is used. Then, as the resin material on the connection portion 7 side with respect to the break portion 9, low-density polyethylene containing no fatty acid amide is used as the second resin material.

This makes it possible to improve the slidability of the lancet case 6 with respect to the guide surface 36.
Then, a part or all of the puncture needle 10 housed in the lancet main body 5 is fixed with an adhesive or the like so that the puncture needle 10 does not come off. That is, as shown in FIG. 20, measures are taken to satisfy the JIS standard needle pulling force of 8 N or more.

Here, when low-concentration polyethylene containing fatty acid amide is used for the entire puncture needle cartridge 4, the lubricity of the polyethylene surface fixing the puncture needle 10 is also improved. Therefore, the adhesive applied to the puncture needle 10 cannot come into contact with the polyethylene, and the pulling force becomes lower than 8N.

Therefore, as described above, low-density polyethylene containing fatty acid amide is used as the first resin material on the side of the piercing needle cover portion 8 having the guide surface 36, and the piercing needle 10 is used as the second resin material. Low-density polyethylene having a higher friction coefficient than low-density polyethylene containing fatty acid amide is used on the 5 side of the stored lancet body.

At this time, when the lancet main body 5 is molded only from low-density polyethylene, the performance of the puncture needle 10 with a pulling force of 8 N or more cannot be ensured, so the root portion of the puncture needle 10 is connected using an adhesive. This makes it possible to improve the pulling force of the puncture needle 10.

Here, as a method for manufacturing the puncture needle cartridge 4, as shown in FIGS. 21 to 24, the low-density polyethylene containing fatty acid amide is a molding die corresponding to the puncture needle cover portion 8 side, that is, FIGS. 21 to 24. It is filled from the gate b shown in. On the other hand, the low-density polyethylene is filled from the molding die corresponding to the lancet main body 5 side, that is, the gate c shown in FIGS. 21 to 24.

The puncture needle cover portion 8 formed of the low-density polyethylene containing fatty acid amide and the lancet originally 5 formed of the low-density polyethylene are joined from the gate b and the gate c so as to be joined in the vicinity of the break portion 9. Resin injection conditions are adjusted.

Then, the low-density polyethylene containing fatty acid amide that forms the puncture needle cover portion 8 side may be injected to a portion that does not affect the adhesive applied to the puncture needle 10. Then, the low-density polyethylene or high-density polyethylene that forms the lancet main body 5 side may be injected to a portion that does not affect the guide surface 36 (the lancet main body 5 side with respect to the guide surface 36).

For example, as shown in FIG. 24, the injection conditions are adjusted so that the low-density polyethylene containing fatty acid amide is slightly injected on the connecting portion 7 side to the portion 5b beyond the fractured portion 9 and bonded to the low-density polyethylene. May be done.

As a result, when the puncture needle cover portion 8 is broken, it can be broken with a smaller force, which makes it easier for the user to use.
As the material of the lancet main body 5 located on the connecting portion 7 side from the broken portion 9, high-density polyethylene may be used instead of the low-density polyethylene.

When high-density polyethylene is used as the resin material of the lancet main body 5, the puncture needle 10 can be held in the lancet main body 5 without applying an adhesive to the puncture needle 10.

Here, the combination of materials is as shown in the table below.

As described above, according to the configuration of the present embodiment, the frictional force generated between the guide surface 36 of the puncture needle cover portion 8 and the lancet case 6 (guide portion 14) is reduced, and the lancet case 6 is subjected to a small force. The broken portion 9 can be broken with a small force. Further, the holding force (pulling force of 8 N or more) of the puncture needle 10 in the lancet main body 5 can be maintained.

As a result, the puncture needle cartridge 4 can be appropriately attached to the puncture device 1.

The present invention is expected to be widely used, for example, as a puncture needle cartridge for puncturing a human body with a needle to measure blood glucose level and allowing blood to flow out, and a puncture device for mounting the puncture needle cartridge.

1 Body case 2 Main body case 3 Front end opening 4 Punch needle cartridge 5 Lancet body 5a Intermediate part 5b part 6 Lancet case 7 Connection part 8 Puncture needle cover part 9 Breaking part 10 Puncture needle 11 Base part 12 Guide protrusion 13 Sliding protrusion 14 Guide part 15 Sliding groove 16 Space 17 Receiving part 18 Grip part 19 Rear end opening 20 Main rod 21 Lancet holder 22 Injection rod 23 Main spring 24 Operation button 25 Bush 26 Sampling cam 27 Lock claw 28 Lock body 29 Engagement claw 30 Operation body 31 Extruded claw 32 Holder insertion cylinder 33 Stopper 34 Engagement claw 35 Outer wall 36 Guide surface 37 Nozzle 38 Reservoir 39 Rib 40 Finger rest (first posture holding part)
41 Non-slip 42 Convex part 43 Finger pad part (second posture holding part)
P1 Sliding start position P2 Sliding end position

Claims (10)

A puncture needle cartridge that is attached to the puncture device.
The puncture needle, a connection portion provided on the second end side opposite to the first end on which the puncture needle is punctured and connected to the puncture device, and a connection portion provided on the first end side and before use. The puncture needle cover portion that covers the tip portion of the puncture needle and the intermediate portion between the first end and the second end are provided and are broken when the puncture is performed, and the puncture needle cover portion is separated. A broken portion that exposes the tip portion of the puncture needle, a guide protrusion provided on the outer peripheral surface of the puncture needle cover portion on the first end side of the broken portion, and the second end of the broken portion. A columnar lancet body with a sliding protrusion provided on the side, and
A spiral guide portion formed from the first end side toward the second end side and imparting a rotational force in a predetermined direction when the guide protrusions are engaged and relatively move in the puncture direction, and the above-mentioned A cylinder mounted on the outer periphery of the intermediate portion of the lancet body, having a sliding groove for guiding movement in the puncture direction with the sliding protrusion engaged, and with the broken portion not broken. Lancet case and
Equipped with
The first part of the puncture needle cover part on the first end side of the broken part is formed of the first resin material.
The second part of the lancet body, which holds the puncture needle and has the connection portion on the second end side of the broken portion of the lancet body, is a second resin material different from the first resin material. Molded by
The first part and the second part are joined in the vicinity of the broken part and are joined together .
The frictional resistance of the second resin material is higher than the frictional resistance of the first resin material.
Puncture needle cartridge. The first resin material is low density polyethylene containing fatty acid amide.
The puncture needle cartridge according to claim 1. The second resin material is low density polyethylene.
The puncture needle cartridge according to claim 1 or 2. The second resin material is high density polyethylene.
The puncture needle cartridge according to claim 1 or 2. The method for manufacturing a puncture needle cartridge according to claim 1.
The first resin material is filled from the molding die corresponding to the puncture needle cover portion on the first end side of the broken portion.
The second resin material is filled from the molding die corresponding to the portion of the lancet main body on the second end side of the broken portion.
At least a portion of the puncture needle is held by the second resin material and
The first part and the second part are joined to each other in the vicinity of the broken part.
Manufacturing method of puncture needle cartridge. The first part and the second part are joined to each other on the second end side of the broken part.
The method for manufacturing a puncture needle cartridge according to claim 5. The first part and the second part are joined to each other between the broken part and the part where at least a part of the puncture needle is held by the second resin material.
The method for manufacturing a puncture needle cartridge according to claim 6. The first portion and the second portion are joined to each other on the second end side of the guide surface provided on the guide protrusion to guide the guide portion.
The method for manufacturing a puncture needle cartridge according to claim 5. The first resin material is low-density polyethylene containing a fatty acid amide.
The second resin material is low density polyethylene.
The method for manufacturing a puncture needle cartridge according to claim 5. The first resin material is low-density polyethylene containing a fatty acid amide.
The second resin material is high density polyethylene.
The method for manufacturing a puncture needle cartridge according to claim 5.

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