Lever-type applicator for microneedles

Abstract

To provide a lever-type applicator for a microneedle excellent in operation stability that can be operated with small force, hardly causes positional deviation or inclination during operation, and allows puncture by the microneedle to be carried out easily and reliably.SOLUTION: A lever type applicator 10 for a microneedle for pressing a microneedle array 11 arranged at the tip side of an applicator body 13 against a target skin 12 includes the applicator body 13 and a lever type operation part 14 for converting a rotational motion to a linear motion. The applicator body 13 includes a trigger member 15 that can be slidably moved along an axial direction of the applicator body 13, and presses the microneedle array 11 against the skin 12 by moving the trigger member 15 toward the tip side of the applicator body 13 in conjunction with the rotational motion of the lever type operation part 14.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a lever-type applicator for a micro needle used for drug administration into the body using a micro needle array instead of a conventionally used syringe for medical or cosmetic purposes.

Background Art

[0002] In the future, as the birthrate declines and the population ages, the role of medicine is expected to increase, leading to a shortage of hospitals, doctors, etc. Medical treatment includes drug treatment in addition to surgical treatment. Among drug treatments, drug administration into the body using a syringe accounts for a large proportion. This syringe-based drug administration is usually performed by qualified personnel such as doctors and nurses in a hospital, but in some cases, such as insulin administration for diabetes, self-administration by the patient at home is permitted. Therefore, if it is possible to popularize home drug administration based on a doctor's prescription, the frequency of hospital visits by patients will decrease, and the burden on doctors and patients (especially the elderly and workers) can be reduced. For this reason, interest in such home drug administration is increasing. In particular, in depopulated areas with problems such as a shortage of hospitals and doctors, the need for home drug administration is great.

[0003] However, while syringe-based drug administration has the advantage of being able to directly administer drugs subcutaneously or into blood vessels, it has the disadvantages of being painful and causing skin damage or swelling as the number of drug administrations increases. Therefore, instead of a syringe, it has been considered to use a resin micro needle array having a plurality of micro needles (microneedles) with sharp tips on a flat plate. The characteristics of this micro needle array are that the micro needles have a length that can reach the depth of painless points under the skin, enabling painless drug administration, and that the patient can easily administer the drug simply by applying it to the epidermis in a patch form, significantly reducing the burden on the patient. Such a micro needle array is expected to be used not only for medical purposes but also for cosmetic purposes. From the above, for the purpose of popularizing the microneedle array, an applicator used when pressing the microneedle array against the skin has been studied (for example, Patent Documents 1 and 2).

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0005] However, the applicators of Patent Document 1 and Patent Document 2 press the microneedle array (microneedle device) against the skin by pressing a cylindrical member and an operation button with a finger and moving a plunger and a piston axially against the force of a spring. Therefore, a strong force is required for the finger, and there is a problem that it is difficult for women, the elderly, etc. to use. Further, as in Patent Document 1, when the applicator main body is formed in a long cylindrical shape in the axial direction and the contact area between the tip portion (microneedle array) and the skin is small, displacement and inclination of the applicator main body are likely to occur during operation, and there is also a problem of lack of operability. The present invention has been made in view of such circumstances, and an object thereof is to provide a lever-type applicator for a microneedle that can be operated with a small force, is less likely to be displaced or inclined during operation, and has excellent operational stability that can easily and surely perform puncture with a microneedle.

Means for Solving the Problems

[0006] The lever-type applicator for a microneedle according to the present invention that meets the above object is a lever-type applicator that presses a microneedle array disposed on the front side of an applicator main body against the target skin, It has the applicator main body and a lever-type operation part that converts rotational motion into linear motion. The applicator main body includes a trigger member that can slide along the axial direction of the applicator main body. By moving the trigger member toward the tip side of the applicator main body in conjunction with the rotational operation of the lever-type operation part, the micro needle array is pressed against the skin.

[0007] In the lever-type applicator for a micro needle according to the present invention, the applicator main body has a cylindrical case. The trigger member has its tip inserted inside the base side of the case and its base side protruding from the base side of the case. The lever-type operation part can have an operation lever whose one end is rotatably held at the base side end of the case, and a link member whose one end is rotatably connected to the base side end of the trigger member and whose other end is rotatably connected to the operation lever.

[0008] In the lever-type applicator for a micro needle according to the present invention, it can be provided with a guide member that is attached to the tip side of the applicator main body and abuts against the skin to support the applicator main body.

[0009] In the lever-type applicator for a micro needle according to the present invention, the guide member preferably has a mounting part formed in a cylindrical shape and fitted to the tip end of the applicator main body, and a contact part that extends to the tip side of the mounting part and curves in an arc shape convex toward the mounting part side to abut against the skin.

Advantages of the Invention

[0010] According to the lever-type applicator for a micro needle of the present invention, by simply rotating the lever-type operation part, the trigger member can be easily and surely moved toward the tip side of the applicator main body with a small force, and the micro needle array can be pressed against the skin to perform puncture and drug injection with the micro needle, which is excellent in labor saving and operation stability.

[0011] In the lever-type applicator for a microneedle according to the present invention, when the applicator main body has a cylindrical case, the tip side of the trigger member is inserted inside the base side of the case, the base side protrudes from the base side of the case, and the lever-type operation part has an operation lever whose one end is rotatably held at the base side end of the case, and a link member whose one end is rotatably connected to the base side end of the trigger member and the other end is rotatably connected to the operation lever, when transmitting the rotational movement of the lever-type operation part to the trigger member via the link member, it can be converted into a linear movement to slide the trigger member, and the force required for the operation (rotational movement) of the operation lever can be significantly reduced by the principle of a lever.

[0012] In the lever-type applicator for a microneedle according to the present invention, when it is provided with a guide member attached to the tip side of the applicator main body and contacting the skin to support the applicator main body, during operation, it can prevent the positional deviation and inclination of the applicator main body from occurring, and can surely press the microneedle array against a predetermined position on the skin.

[0013] In the lever-type applicator for a microneedle according to the present invention, when the guide member has a mounting part formed in a cylindrical shape and fitted to the tip end part of the applicator main body, and a contact part extending to the tip side of the mounting part and curved in an arc shape convex toward the mounting part side and contacting the skin, the attachability and detachability of the guide member to the applicator main body are excellent, the adhesion between the skin and the contact part is enhanced, and the support stability of the applicator main body by the guide member can be improved.

Brief Description of the Drawings

[0014]

Figure 1

Figure 2

Figure 3

Figure 4

Mode for Carrying Out the Invention

[0015] Subsequently, embodiments of the present invention will be described with reference to the attached drawings. The lever-type applicator 10 according to an embodiment of the present invention shown in FIGS. 1 to 3 (hereinafter simply referred to as "lever-type applicator") is used when pressing the micro-needle array 11 against the skin 12 of a patient or the like as an object for drug administration or the like into the body. As shown in FIGS. 1(A) and (B), the lever-type applicator 10 has an applicator body 13 to which the micro-needle array 11 is attached on the front side, and a lever-type operation unit 14 that converts a rotational motion into a linear motion. And, as shown in FIGS. 1(A), 2, and 3, the applicator body 13 includes a trigger member 15 that is slidable along the axial direction of the applicator body 13. As shown in FIG. 1(A), by moving (linear motion) the trigger member 15 toward the front side of the applicator body 13 in conjunction with the rotational motion (arrow a) of the lever-type operation unit 14 (arrow b), the micro-needle array 11 can be pressed against the skin 12.

[0016] As shown in FIGS. 2 and 3(A) to (C), the applicator main body 13 has a cylindrical (here, circular cylindrical) case 17. The trigger member 15 has its tip inserted inside the base side of the case 17, and its base side protruding from the base side of the case 17. And as shown in FIGS. 1(A) and 1(B), the lever-type operation unit 14 has an operation lever 18 whose one end is rotatably held at the base side end of the case 17, and one end is rotatably connected to the base side end of the trigger member 15 and the other end is rotatably connected to the operation lever 18. a link member 19. Thus, as shown in FIG. 1(A), when the operation lever 18 is rotated in the direction of arrow a, the trigger member 15 pulled through the link member 19 moves in the direction of arrow b (toward the tip side of the applicator main body 13). In the present embodiment, the force required to rotate the operation lever 18 is reduced to about 1 / 5 to 1 / 6 of the force when directly pressing the trigger member 15.

[0017] Note that the positional relationship of the first rotation axis 21 that rotatably connects the base side end of the case 17 and one end of the operation lever 18, the second rotation axis 22 that rotatably supports the base side end of the trigger member 15 and one end of the link member 19, and the third rotation axis 23 that rotatably connects the other end of the link member 19 and the operation lever 18 is appropriately selected, and according to the distance from the first rotation axis 21 to the third rotation axis 23 and the distance from the second rotation axis 22 to the third rotation axis 23, the rotation amount of the operation lever 18 and the movement amount of the trigger member 15 change, and the force required for the operation (rotation operation) of the operation lever 18 also changes. Further, in the present embodiment, the case 17 and the operation lever 18 are connected by sandwiching the base side end of the case 17 from both sides at one end of the operation lever 18 formed in a bifurcated shape, and the trigger member 15 formed in a bifurcated shape is used. The trigger member 15 and the link member 19 are connected by sandwiching one end of the link member 19 from both sides at the base side end portion, but each part only needs to be rotatably connected to each other, and its structure is appropriately selected. Furthermore, the lever-type operation unit only needs to be able to convert a rotational motion into a linear motion, and its structure is not limited to the present embodiment, and is appropriately selected and realized by various link mechanisms.

[0018] Next, the internal structure of the lever type applicator 10 will be described. As shown in FIGS. 2, 3(A) to 3(C), the lever type applicator 10 has a base side inserted into the front side inside of the case 17 and a front side held by the case 17 so as to protrude from the front side of the case 17. A micro needle array 11 is detachably attached to the tip portion, and it has a knocker pin 25 slidable in the axial direction of the case 17. Further, the lever type applicator 10 has a hammer member 26 housed between the trigger member 15 and the knocker pin 25 inside the case 17 and slidable in the axial direction of the case 17. A first coil spring 27 is disposed between the front side of the trigger member 15 and the base side of the hammer member 26, and a second coil spring 28 is disposed between the front side of the hammer member 26 and the base side of the knocker pin 25.

[0019] The trigger member 15 has a cylindrical portion 30 with an open front side, and the first coil spring 27 is housed in the cylindrical portion 30. The trigger shaft 31 extending to the base side of the cylindrical portion 30 protrudes from the base side of the case 17, and its base end is formed with a larger diameter than other portions. The hammer member 26 has a base side shaft portion 32 inserted into the front side of the first coil spring 27. A tapered portion 33 whose diameter expands toward the front side of the hammer member 26 is formed at the front side of the base side shaft portion 32. A cylindrical body portion 34 is formed at the front side of the tapered portion 33, and a front side shaft portion 35 inserted into the second coil spring 28 is formed at the front side of the body portion 34. Inside the case 17, a partition portion 37 that partitions between the front side of the hammer member 26 and the base side of the knocker pin 25 is provided. A through hole 38 through which the front side shaft portion 35 of the hammer member 26 can advance and retreat is formed at the center of the partition portion 37.

[0020] The hammer member 26 has its maximum diameter at the body portion 34. The outer diameter of this body portion 34 is smaller than the inner diameter of the case 17, and the outer diameters of the base - side shaft portion 32 and the tip - side shaft portion 35 are also smaller than the inner diameters of the first coil spring 27 and the second coil spring 28, respectively. The hammer member 26 has a spring receiving surface 39 that abuts against the base - side end of the second coil spring 28 on the base - side outer periphery of the tip - side shaft portion 35. Since the spring receiving surface 39 is inclined with respect to the surface orthogonal to the axial direction of the hammer member 26, in the initial state, as shown in FIG. 2, the base - side end of the second coil spring 28 abuts against the spring receiving surface 39, and the hammer member 26 supported by the base - side end of the second coil spring 28 can be reliably and automatically (forcedly) inclined (the axis of the hammer member 26 is inclined with respect to the axis of the case 17). Note that it is not always necessary to incline the spring receiving surface of the hammer member. If necessary, the lever - type applicator 10 can be shaken, or the axial direction of the case 17 can be temporarily tilted from the vertical direction and then returned to the vertical direction to incline the axis of the hammer member with respect to the axis of the case.

[0021] A knocker - pin holding portion 40 is formed at the tip of the partition portion 37 of the case 17. The knocker pin 25 has a base - end portion 41 slidably held by the knocker - pin holding portion 40, and a shaft portion 42 formed on the tip side of the base - end portion 41 with a diameter smaller than the outer diameter of the base - end portion 41 and protruding from the tip of the case 17. An adapter member 44 to which the micro - needle array 11 is detachably attached is removably mounted at the tip of this shaft portion 42. By replacing the adapter member according to the type (shape) of the micro - needle array, it is possible to correspond to a wide variety of micro - needle arrays. In this embodiment, the micro - needle array 11 is mounted on the adapter member 44 via the holder 45, but the shape and structure of the holder can be appropriately selected, and it is also possible to directly mount the micro - needle array on the adapter member without using the holder.

[0022] At the base and tip ends of Case 17, first and second cap members 47 and 48 are detachably attached respectively. By removing the lever-type operation unit 14 and the first and second cap members 47 and 48 from the applicator body 13, the applicator body 13 (Case 17) can be easily disassembled. If necessary, the first coil spring 27 can be replaced to adjust the puncture speed (puncture depth) of the micro needle. Note that the shapes of the first and second cap members can be appropriately selected. Also, the material of the case can be metal or synthetic resin. When the case is formed of synthetic resin, it is also possible to form the case by half-splitting it along a cutting plane in the longitudinal direction.

[0023] The usage method of the lever-type applicator 10 configured as described above will be explained. Since there is no spring or the like in the knocker pin holding portion 40 that restricts the sliding of the knocker pin 25, when the applicator body 13 (Case 17) is tilted so that the micro needle array 11 faces downward, the knocker pin 25 moves to the tip side of Case 17, and as shown in FIGS. 1(A) and 2, the holder 45 with the micro needle array 11 attached to its tip protrudes from the second cap member 48. Therefore, the user (such as a patient) of the lever-type applicator 10 can bring it into contact with a predetermined position on the skin 12 while visually confirming the micro needle array 11. Then, when the applicator body 13 (Case 17) is moved toward the skin 12, the base end portion 41 of the knocker pin 25 slides inside the knocker pin holding portion 40 toward the base side of Case 17, and as shown in FIG. 3(A), the micro needle array 11 retracts into the second cap member 48, and the tip of the second cap member 48 comes into contact with the surface of the skin 12. At this time, since the knocker pin 25 slides with almost no load, the user does not feel pain.

[0024] When the user rotates the operation lever 18 in the direction of arrow a while supporting the applicator main body 13 (case 17) by hand (see Fig. 1(A)), the hammer member 26 together with the trigger member 15 moves toward the front side of the case 17 while compressing the first and second coil springs 27 and 28. At this time, as described above, since the axis of the hammer member 26 is inclined with respect to the axis of the case 17, as shown in Fig. 3(A), the front end portion of the front side shaft portion 35 of the hammer member 26 engages with the partition portion 37 at the base side periphery of the through hole 38, and the hammer member 26 stops. When the operation lever 18 is further rotated, the first coil spring 27 is compressed between the trigger member 15 moving toward the front side of the case 17 and the stopped hammer member 26. Then, when the peripheral edge of the opening at the front side of the cylindrical portion 30 of the trigger member 15 that continues to move engages with the tapered portion 33 of the hammer member 26, as shown in Fig. 3(B), the posture of the hammer member 26 is corrected, and the axis of the hammer member 26 coincides with the axis of the case 17. As a result, the front side shaft portion 35 of the hammer member 26 becomes capable of entering the through hole 38. As shown in Fig. 3(C), the first coil spring 27 extends to move the hammer member 26 toward the front side of the case 17 and compresses the second coil spring 28 between the body portion 34 and the partition portion 37. Then, the front side shaft portion 35 of the hammer member 26 that has entered the through hole 38 collides with the base end portion 41 of the knocker pin 25 to apply a strike. At this time, even if the protruding amount of the front side shaft portion 35 protruding from the front side of the through hole 38 is small, the knocker pin 25 struck with the elastic energy stored in the first coil spring 27 can move by its momentum until the front end surface of the base end portion 41 abuts against the front end surface of the knocker pin holding portion 40 as shown in Fig. 3(C), and the micro needle array 11 can be strongly pressed against the skin 12 so as to dent the skin 12. Note that by using the elastic energy stored in the first coil spring 27 to move the knocker pin 25 (protrude it from the front side of the case 17) to press the micro needle array 11 against the skin 12, the knocker pin 25 does not need to face downward and can be used in various postures, and can also be used in a horizontal or upward posture. When the user releases their hand from the operation lever 18, the second coil spring 28 extends (restores), automatically returning to the initial state (see Fig. 2). Therefore, a new micro needle array 11 can be attached to the tip of the knocker pin 25 (the tip of the adapter member 44) via a holder 45 (or without using the holder 45) in preparation for the next use.

[0025] Regarding the hammer member, as shown by the two-dot chain line in Figs. 2, 3(A) to (C), it can also be divided into two in the middle of the longitudinal direction of the body portion. In that case, the tip side of the hammer member including the tip side shaft portion can rotate around the axis of the tip side shaft portion, and the position of the tip end portion that engages with the partition portion at the base side periphery of the through hole moves (changes) at any time. Therefore, it is possible to prevent the specific position of the tip end portion from wearing, and improve the durability and operation stability of the hammer member. Also, in this embodiment, the case where the micro needle array is attached to the tip of the knocker pin (the tip of the adapter member) via a holder has been described. However, the micro needle array can also be placed on the surface of the skin in advance and fixed with tape or the like, and the tip of the knocker pin (adapter member) can be pressed against the micro needle array and pressed against the skin.

[0026] On the front side of the applicator body 13, as shown in FIGS. 4(A) and 4(B), a guide member 50 that abuts against the skin 12 and supports the applicator body 13 can also be attached. The guide member 50 has a mounting portion 51 formed in a cylindrical shape and fitted to the tip of the applicator body 13, and a contact portion 52 that extends to the front side of the mounting portion 51 and curves in an arc shape convex toward the mounting portion 51 side (here, the upper side) in a side view and abuts against the skin 12. A through hole (not shown) through which the micro needle array 11 can pass is formed in the contact portion 52 in accordance with the position of the mounting portion 51. Thereby, for example, even with respect to the skin 12 such as the arm 53 whose surface is curved as shown by the phantom line, the micro needle array 11 can be surely pressed against a predetermined position without causing displacement or inclination of the applicator body 13. When the guide member 50 is attached to the applicator body 13 (case 17), the direction of the contact portion 52 can be appropriately changed (selected) by rotating the guide member 50 around the axis of the applicator body 13 according to the position of the target skin (affected part) and the ease of use for the user. For example, the guide member 50 may be rotated 90 degrees from the states shown in FIGS. 4(A) and 4(B) and used such that the contact portion 52 is arc-shaped in a front view.

[0027] As the material of the guide member, synthetic resins such as polypropylene, polycarbonate, and polyethylene are preferably used, but are not limited thereto and are appropriately selected. For example, the contact portion may be formed of a flexible (deformable) material such as silicone rubber and deformed to conform to the surface shape of the target site. Further, among the contact portions formed of synthetic resin, a soft or elastic coating material formed of plate-shaped synthetic rubber or the like is attached to the surface (back surface) that abuts against the skin, so that when the contact portion is pressed against the skin, it is difficult for a subject such as a patient to feel pain, and the contact portion is also difficult to slip (difficult to be displaced). The shape and size of each part of the guide member and the method of attaching it to the applicator body are not limited to this embodiment and are appropriately selected. Further, a plurality of guide members having different shapes and sizes may be prepared and the guide members may be exchanged according to the physique of the subject, the surface shape or size of the target site, or the like.

[0028] Although the embodiments of the present invention have been described above, the present invention is not limited to the configurations described in the above embodiments, and includes other embodiments and modifications that can be considered within the scope of the matters described in the claims. For example, in the above embodiment, the case is formed in a cylindrical shape, but unevenness may be formed on the outer surface of the case as appropriate. When the case is formed so as to be dividable into first and second divided cases, instead of fixing the base-side and tip-side ends of the case with first and second cap members, first and second engaging convex portions and engaging concave portions that engage with each other may be formed on the divided cases for fixing. Further, the applicator body only needs to be able to accommodate a trigger member, a knocker pin, a hammer member, and first and second coil springs inside to perform a predetermined operation, and the divided shape and the number of divisions of the case are appropriately selected. In the above embodiment, the peripheral edge (inner periphery) of the opening at the tip of the cylindrical portion of the trigger member is formed in a tapered shape that expands in diameter toward the tip, but it may be formed straight. The shape of the hammer member is also appropriately selected. For example, in the above embodiment, a cylindrical portion is formed between the base-side shaft portion and the tapered portion, but the cylindrical portion may be omitted, for example. Further, in the above embodiment, the adapter member is screwed to the shaft portion of the knocker pin, but the adapter member only needs to be detachable from the knocker pin, and the fixing method is appropriately selected. For example, the two may be fixed by fitting (inserting), or a convex portion formed on one and a concave portion formed on the other may be engaged and fixed. Note that the applicator body only needs to be able to press the micro needle array against the skin at the tip side of the applicator body as the trigger member slides, and its internal structure is not limited to the above embodiment and is appropriately selected.

Explanation of Reference Numerals

[0029] 10: Lever-type applicator, 11: Microneedle array, 12: Skin, 13: Applicator body, 14: Lever-type operation unit, 15: Trigger member, 17: Case, 18: Operation lever, 19: Link member, 21: First rotation axis, 22: Second rotation axis, 23: Third rotation axis, 25: Knocker pin, 26: Hammer member, 27: First coil spring, 28: Second coil spring, 30: Cylindrical portion, 31: Trigger shaft, 32: Base-side shaft portion, 33: Taper portion, 34: Body portion, 35: Tip-side shaft portion, 37: Partition portion, 38: Through hole, 39: Spring receiving surface, 40: Knocker pin holding portion, 41: Base end portion, 42: Shaft portion, 44: Adapter member, 45: Holder, 47: First cap member, 48: Second cap member, 50: Guide member, 51: Mounting portion, 52: Contact portion, 53: Arm

Claims

1. A lever-type applicator that presses a micro-needle array disposed on the front side of an applicator body against the target skin, comprising the applicator body and a lever-type operating portion that converts a rotational motion into a linear motion. The applicator body includes a cylindrical case, and a trigger member that has a tip inserted into the base side inside the case and a base side protruding from the base side of the case and is slidable along the axial direction of the applicator body. The lever-type operating portion includes an operating lever having one end rotatably held at the base side end of the case, and a link member having one end rotatably connected to the base side end of the trigger member and the other end rotatably connected to the operating lever. By moving the trigger member toward the front side of the applicator body in conjunction with the rotational movement of the lever-type operating portion, the micro-needle array is pressed against the skin. A lever-type applicator for micro-needles, characterized in that.

2. The lever-type applicator for micro-needles according to claim 1, further comprising a guide member attached to the front side of the applicator body and contacting the skin to support the applicator body. A lever-type applicator for micro-needles, characterized in that.

3. The lever-type applicator for micro-needles according to claim 2, wherein the guide member has a mounting portion formed in a cylindrical shape and fitted to the tip of the applicator body, and a contact portion extending from the front side of the mounting portion and curved in an arc convex toward the mounting portion side to contact the skin. A lever-type applicator for micro-needles, characterized in that.

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