CN108939284B - Dissolvable Microneedle Injection Device - Google Patents

Abstract

The invention relates to a dissolvable microneedle injection device, comprising a propulsion device, an injection substrate and a dripping device, the injection substrate is used to fix a microneedle film for injection, the microneedle film includes a microneedle base and microneedles on the microneedle base, the microneedle The needle film is fixed on the back of the injection substrate, the injection substrate can be water-permeable or water-absorbent, the propulsion device is used to push the injection substrate to pierce the microneedle into the site to be injected, the dripping device is used to drip water on the injection substrate, and the aqueous solution dissolves the microneedle film through the injection substrate The microneedle base of the injection substrate, or the microneedle base of the injection substrate absorbing the aqueous solution to dissolve the microneedle film. The beneficial effects of the present invention are: the dissolvable microneedle film is connected with a water-permeable or water-absorbing injection substrate, and after the microneedle penetrates into the skin, the microneedle base connected with the injection substrate is dissolved through a dripping device, and the separated microneedle Continue to keep the controllable dissolution and release of internal active substances in the skin, and realize the precise dosage of microneedle injection.

Description

Dissolvable Microneedle Injection Device

technical field

The invention relates to a dissolvable microneedle injection device.

Background technique

Transdermal drug delivery is widely used as an effective way for drug delivery because it can avoid the degradation of polymers in the gastrointestinal tract and is convenient to use. Conventionally, external preparations containing medicinal ingredients have been used in order to subcutaneously exert pharmacological effects of the medicinal ingredients. As such external preparations, liquid preparations, ointments, cream preparations, adhesive tape preparations, patches, poultices, etc. are known, and by applying or sticking them locally, the medicinal ingredients are absorbed percutaneously and subcutaneously exert the expected pharmacological effect. However, the above-mentioned external preparations in the form of coating or sticking have the following disadvantages: due to the barrier function of the skin, the medicinal ingredients cannot be sufficiently transdermally absorbed, and cannot exert desired pharmacological effects. Especially when the medicinal ingredient is a high molecular compound, it is difficult to absorb through the skin, and it is difficult to exert the desired pharmacological effect in the external preparation. Furthermore, during use, due to sweating, washing, external pressure, etc., the medicinal ingredients may fall off or disappear before being transdermally absorbed. In recent years, microneedle arrays in which microneedles containing medicinal ingredients have been added have been extensively studied as a technique for solving the above-mentioned disadvantages of external preparations. For example, Chinese Patent Publication No. 102580232A discloses a scheme of a microneedle array mainly made of silk fibroin as a microneedle raw material. By penetrating the microneedles into the surface layer of the skin and/or the stratum corneum of the skin, the medicinal ingredients in the microneedles are supplied to the subcutaneous area, and the part of the punctured microneedles can be dissolved or biodegraded subcutaneously to disappear. In addition, microneedles are suitable as a method of subcutaneously supplying medicinal ingredients because the needles are very thin, so that no pain or bleeding occurs even when piercing the skin surface and/or the stratum corneum, and the puncture wounds are quickly closed. Such microneedle arrays need to be optimally designed according to skin symptoms, and various microneedle arrays need to be developed and provided. The microneedles used as external preparations need to combine (1) strength to withstand penetration into the skin surface and/or skin stratum corneum, (2) in order not to penetrate into the skin surface and/or skin stratum corneum The fineness and softness that cause pain or bleeding, and (3) the solubility or biodegradability of the part of the microneedle that penetrates into the skin in the body, etc. In the past, the base of this type of microneedle film was made of the same hard material as the microneedle, and the microneedle and the base could not be separated. After the microneedle penetrated the skin, the hard base had to be pressed against the skin surface and waited for the drug injection to complete. , the substrate can be peeled off, which brings discomfort to the user.

Contents of the invention

The technical problem to be solved by the present invention is: the base of the existing microneedle film is integrated with the microneedle. After the microneedle penetrates the skin, the hard base must be pressed on the skin surface, and it can be peeled off only after the drug injection is completed. Substrate, this brings discomfort to the user, and it is difficult to control the release rate and drug loading of the drug.

The technical solution adopted by the present invention to solve the technical problem is: a dissolvable microneedle injection device, including a propulsion device, an injection substrate and a dripping device, the injection substrate is used to fix the microneedle film for injection, and the microneedle film includes a microneedle base And the microneedle on the microneedle base, the microneedle film is fixed on the back of the injection substrate, the injection substrate can be water-permeable or water-absorbent, the propulsion device is used to push the injection substrate to pierce the microneedle into the site to be injected, and the dripping device is used to drip water to the injection substrate , the aqueous solution passes through the injection substrate to dissolve the microneedle base of the microneedle film, or the injection substrate absorbs the aqueous solution to dissolve the microneedle base of the microneedle film.

It is further defined that the injection substrate is composed of a water-permeable sheet or a water-absorbing sheet alone, and the water-permeable sheet is permeable through the water-permeable holes on the water-absorbing sheet. The back of the permeable sheet.

Preferably, the back of the water-permeable sheet has a guide channel communicating with the water-permeable holes, so as to evenly guide the aqueous solution passing through the water-permeable sheet to the entire microneedle base.

It is further defined that the propulsion device includes a push rod, the injection substrate is installed at the front end of the push rod, and the push rod has a push rod channel leading to the front of the injection substrate, and the dripping device is directly arranged in the push rod channel, or the dripping device directly uses the push rod The channel injects the pumped aqueous solution to the front of the injection substrate, or the dripping device has a drip tube inserted into the push rod channel, the outlet end of the drip tube is located above the adjacent injection substrate, and the pumped aqueous solution is injected into the injection substrate through the drip tube. front.

It is further defined that the water outlet end of the drip pipe is blocked by an elastic flap, so that the water outlet is in a normally closed state, and the elastic flap is pushed open by the pressure of the pumped aqueous solution, so that the aqueous solution flows out through the water outlet, or the water outlet of the drip pipe The end adopts the outlet with smaller diameter.

It is further defined that for the sealing of the water outlet end of the drip pipe, the sealing surface is divided into a plurality of elastic flaps by crossing dividing lines.

To further define, the dripping device has the following several specific solutions: the dripping device includes a water storage container and a piston in the water storage container, and the dripping device pumps out the aqueous solution in the water storage container through the piston; or, the dripping device includes a water storage container, and the water storage The container can be compressed and deformed, and the dripping device pumps out the aqueous solution in the water storage container by compressing the water storage container; or, the dripping device includes a water storage container and a spike, and the water storage container has an upper, For the lower port, the dripping device makes the aqueous solution in the water storage container flow out by piercing the sealing film of the upper and lower ports of the water storage container from top to bottom through the thorn.

Further defined, the propulsion device also includes an outer sleeve, a power spring and an injection switch mechanism. The push rod is located in the outer sleeve, and the push rod is locked in the initial position by the injection switch mechanism. Push the injection base plate to pierce the microneedle into the site to be injected, and the dripping device completes the dripping action with the power of the power spring, or the dripping device completes the dripping action with the operating force of the injection switch mechanism.

It is further defined that the injection switch mechanism includes a switch holder fixed relative to the inner wall of the outer sleeve, and a switch buckle and an unlocking mechanism on the push rod. When the push rod rises to the initial position, the switch buckle of the push rod clamps the switch holder, The push rod is locked at the initial position, and the outer casing has an unlocking mechanism, which pushes the switch buckle to disengage from the switch holder, so that the push rod is unlocked.

It is further defined that the unlocking mechanism is a side button on the side of the outer sleeve. The setting position and quantity of the side button are consistent with the position and number of the switch buckle. By pressing the side button, the inner end of the side button acts on the switch buckle from outside to inside. On the outside, push the switch buckle to deform inward until it breaks away from the switch holder.

Or, the unlocking mechanism is an end button at the rear end of the outer casing, and the top button is inserted into the rear end of the outer casing. The lower edge acts on the outside of the switch buckle from top to bottom, pushing the switch buckle to deform inward until it breaks away from the switch holder.

It is further defined that when the dripping device includes a water storage container and a piston in the water storage container, the water storage container and the piston are sleeved on the push rod, the inner cavity of the water storage container is communicated with the push rod channel of the push rod, and the water storage container is connected to the push rod. The rod is fixedly matched, the piston and the push rod are slidably matched, the piston faces the injection substrate, and the inner wall of the outer casing has an upwardly protruding piston push piece, which is located below the piston. When the push rod descends under the action of the power spring, The piston pusher blocks the piston and pushes the piston to pump out the aqueous solution.

Or, when the dripping device is a compressible water storage container, the water storage container is arranged below the end button, and when the top button is pressed down to unlock the push rod, the end button compresses the water storage container to pump out the aqueous solution.

Or, when the dripping device includes a water storage container and a thorn, the thorn is inserted into the push rod channel, the rear end of the thorn is connected to the end button, the water storage container is located at the lower part of the push rod channel, and the end button is pressed down to unlock When pushing the rod, the end button drives the stabbing rod to pierce the sealing film of the upper and lower ports of the water storage container from top to bottom, so that the aqueous solution in the water storage container flows out.

It is further defined that the side of the outer casing also has a movable push piece, which can be assembled on the outer casing up and down, and the inner end of the movable push piece acts on the push rod, and the movable push piece is moved upward by operating the movable push piece The inner end of the drive rod overcomes the spring force of the power spring and moves downward until the switch buckle of the push rod blocks the switch holder.

Further defined, the unlocking mechanism is elastically reset.

The beneficial effects of the present invention are: the dissolvable microneedle film is connected with a water-permeable or water-absorbing injection substrate; Continue to keep the controllable dissolution and release of internal active substances in the skin, and realize the precise dosage of microneedle injection.

Description of drawings

Below in conjunction with accompanying drawing and embodiment the present invention is further described;

Fig. 1 is a schematic cross-sectional view of Embodiment 2 of the present invention in a ready state for injection.

Fig. 2 is a schematic cross-sectional view of Embodiment 2 of the present invention in a state of completion of injection.

Fig. 3 is a schematic diagram of the external structure of Embodiment 3 of the present invention.

Fig. 4 is a schematic cross-sectional view of Embodiment 3 of the present invention in a ready state for injection.

Fig. 5 is an exploded view of Embodiment 3 of the present invention.

Fig. 6 is an exploded sectional view of Embodiment 3 of the present invention.

Fig. 7 is a schematic structural diagram of a dripping device according to Embodiment 3 of the present invention.

FIG. 8 is a schematic diagram of the front state structure of the injected substrate according to Embodiment 3 of the present invention.

FIG. 9 is a schematic view showing the structure of the back surface of the injected substrate according to Embodiment 3 of the present invention.

Fig. 10 is a schematic diagram of the external structure of Embodiment 4 of the present invention.

Fig. 11 is a schematic cross-sectional view of Embodiment 4 of the present invention before preparation for injection.

Fig. 12 is a schematic cross-sectional view of Embodiment 4 of the present invention during the injection process.

Fig. 13 is an exploded view of Embodiment 4 of the present invention.

Fig. 14 is an exploded sectional view of Embodiment 4 of the present invention.

FIG. 15 is a schematic diagram of the front state structure of the water-permeable sheet of the injected substrate according to Embodiment 3 of the present invention.

FIG. 16 is a schematic view showing the structure of the back surface of the water-permeable sheet of the injected substrate according to the third embodiment of the present invention.

In the figure, 1. Microneedle film, 2. Injection substrate, 2-1. Water-permeable sheet, 2-1-1. Water-permeable hole, 2-1-2. Diversion channel, 2-2. Water-absorbing sheet, 3. Push Rod, 3-1. Push rod channel, 4-1. Drip tube, 4-2. Water storage container, 4-3. Piston, 4-4. Spike, 4-5. Sealing film, 5. Outer sleeve, 6. Power spring, 7. Switch holder, 8. Switch buckle, 9. Side button, 10. End button, 11. Movable push piece, 12. Piston push piece, 13. Water filling hole, 14. Safety sealing rod , 15. Convex circle.

Detailed ways

Example 1:

A dissolvable microneedle injection device, including a propulsion device, an injection substrate 2 and a dripping device, the injection substrate 2 is used to fix a microneedle film 1 for injection, the microneedle film 1 includes a microneedle base and microneedles on the microneedle base, The microneedle film 1 is fixed on the back of the injection substrate 2, and the injection substrate 2 is a combination of a water-permeable sheet 2-1 and a water-absorbent sheet 2-2, and the water-absorbent sheet 2-2 is located on the back of the water-permeable sheet 2-1. The water-permeable sheet 2-1 is permeable through the water-permeable holes 2-1-1 on the water-permeable sheet 2-1, and the water-absorbent sheet 2-2 is made of a water-absorbable material. The propulsion device is used to push the injection substrate 2 to pierce the microneedle into the site to be injected. The dripping device is used to drip water to the injection substrate 2. The aqueous solution passes through the water-permeable sheet 2-1 of the injection substrate 2 and is absorbed by the water-absorbing sheet 2-2. The water-absorbing sheet 2-2 The absorbed aqueous solution quickly dissolves the microneedle base of the microneedle film 1, thereby separating the microneedles piercing the skin from the upper microneedle base, so that the microneedles remain in the skin and precisely release the soluble amount of medicine.

Preferably, the dissolvable microneedle film 1 is fixed on the injection substrate 2 by an adhesive, which can be a dissolvable adhesive, such as a dissolvable adhesive made from pharmaceutical excipients such as protein or starch, such as protein adhesive Glue, and starch glue made from rice, wheat, corn, and potato.

The water-permeable sheet 2-1 and the water-absorbent sheet 2-2 can be made of hydrophilic materials, such as polyvinyl acetate substrate, ethylene-vinyl acetate copolymer substrate, water-absorbing sponge sheet, water-absorbing fiber material, etc. In addition, the water-permeable sheet 2- 1 and the water-absorbing sheet 2-2 are stamped with many tiny water-permeable holes to increase the water-permeable speed and water-permeable capacity.

The aqueous solution may be a pure aqueous solution, or a medicinal aqueous solution containing medicinal components, or a cosmetic aqueous solution containing cosmetic and skin care components. Aqueous solutions containing pharmaceutical ingredients or beauty and skin care ingredients can penetrate into the skin along with the micropores left after the microneedles dissolve. The micropores penetrate into the skin together to achieve a cosmetic effect.

The propulsion device is a push rod 3, and the injection substrate 2 is installed at the front end of the push rod 3. The push rod 3 has a push rod channel 3-1 leading to the front of the injection substrate 2. The dripping device directly uses the push rod channel 3-1 to pump out The aqueous solution is injected to the front of the injection substrate 2, and the microneedle is injected into the human body by manually pushing the push rod.

The dripping device comprises a water storage container 4-2 and a piston 4-3 in the water storage container 4-2, and the dripping device pumps out the aqueous solution in the water storage container 4-2 by the piston 4-3.

The microneedle film is made of biodegradable microneedle material, and one or more active substances for medical or cosmetic purposes are added to the biodegradable microneedle material.

A method for preparing a microneedle film system, the microneedle film system includes a microneedle film 1 and an injection substrate 2, and has the following steps:

1) Making a microneedle negative mold;

2) Filling the microneedle prepolymer solution in the microneedle groove of the microneedle female mold and solidifying;

Step 2 is specifically: press the microneedle female mold on the flat plate coated with liquid microneedle material, fill the microneedle groove of the microneedle female mold with the microneedle prepolymer solution, and the microneedle prepolymer solution Remove the plate after curing, leaving the cured microneedles in the microneedle female mold; or, directly apply the liquid microneedle material on the microneedle female mold, and then use the flat plate to press on the microneedle female mold, so that The microneedle groove of the microneedle female mold is filled with the microneedle prepolymer solution, and the plate is removed after the microneedle prepolymer solution solidifies, leaving the cured microneedle in the microneedle female mold;

3) The water-absorbent sheet 2-2 is coated with viscose on both sides, one side is glued to the water-permeable sheet 2-1, and the other side is glued and pressed on the microneedle base of the microneedle film 1 that has been solidified and formed in the microneedle female mold;

4) The dissolvable microneedle film 1 bonded to the water-absorbing sheet 2-2 is separated from the microneedle female mold to obtain a dissolvable microneedle film system.

Biodegradable microneedle materials can be selected from silk fibroin, collagen, gelatin, hydrogel, carboxymethylcellulose, hydroxypropylmethylcellulose, chondroitin sulfate, glycogen, dextrin, amylose , hyaluronic acid, polylactic acid-glycolic acid copolymer, polylactic acid-glycolic acid copolymer, polyglycol ester, polyacrylic acid, polypropylene, polycarbonate, polystyrene, polyethylene, polyvinyl chloride, ABS plastic (propylene Nitrile-butadiene-styrene copolymer), polydimethylsiloxane, polyvinylidene fluoride, cellulose acetate, polyester, polyurethane, polydioxetanone, poly(ethylene glycol), poly(lactic acid ), polyacrylamide polymers, cycloolefin copolymers, carboxymethyl chitosan, poly-L-lactic acid, alginic acid, dextran, dextran sulfate, hydroxypropyl methylcellulose, chitin, poly Vinylpyrrolidone, lactose, galactose, trehalose, sucrose, maltose, dextran, glycoside, fructose, chitosan, agarose, sorbitol, mannitol or xylitol, proteoglycan, phosphatidylcholine, Polylactide, polyglycolide, hydroxypropyl cellulose, wax, polyester, polyanhydride, polyamide, phosphorous polymer, poly(cyanoacrylate), polyurethane, polyorthoester, polydihydropyridine One or a combination of pyrans, polyacetals, biodegradable polymers, polypeptides, and carbohydrates.

Active substances for medical or cosmetic use can be pharmaceutical or cosmetic molecules, including citric acid, proteins, peptides, polysaccharides, antigens, immunogens, vaccines, antibodies, enzymes, nucleic acids, aptamers, viruses, bacteria, cells, hormones, antibiotics , anticancer drugs, genetic engineering drugs, natural product drugs, traditional Chinese medicine ingredients, nutritional ingredients, therapeutic agents, diagnostic agents, and combinations of the above reagents.

On the basis of embodiment 1, there are following alternatives:

1. The injection substrate 2 is composed of a water-permeable sheet 2-1 or a water-absorbent sheet 2-2 alone.

2. The dripping device has a dripping tube 4-1 inserted into the push rod channel 3-1. The outlet end of the dripping tube 4-1 is located above the injection substrate 2, and the pumped aqueous solution is poured into the injection substrate 2 through the dripping tube 4-1. front.

Preferably, the water outlet end of the drip pipe 4-1 is blocked by an elastic flap, so that the water outlet is in a normally closed state, and the elastic flap is pushed open by the pressure of the pumped aqueous solution, so that the aqueous solution flows out through the water outlet.

Specifically, one of the solutions for forming the elastic flaps is: the water outlet end of the drip pipe 4-1 is closed, and the sealing surface is divided into multiple elastic flaps by crossing dividing lines.

3. The dripping device includes a water storage container 4-2, which is compressible and deformable, and the dripping device pumps out the aqueous solution in the water storage container 4-2 by compressing the water storage container 4-2.

4. The dripping device includes a water storage container 4-2 and a thorn bar 4-4. The water storage container 4-2 has upper and lower ports closed by a pierceable sealing film 4-5, and the dripping device passes through the thorn bar 4-4. The aqueous solution in the water storage container 4-2 is made to flow out by piercing the sealing film 4-5 of the upper and lower ports of the water storage container 4-2 from top to bottom.

Embodiment 2, as shown in Figures 1 and 2:

A dissolvable microneedle injection device, including a propulsion device, an injection substrate 2 and a dripping device, the injection substrate 2 is used to fix a microneedle film 1 for injection, the microneedle film 1 includes a microneedle base and microneedles on the microneedle base, The microneedle film 1 is fixed on the back of the injection substrate 2, and the injection substrate 2 is a combination of a water-permeable sheet 2-1 and a water-absorbent sheet 2-2, and the water-absorbent sheet 2-2 is located on the back of the water-permeable sheet 2-1. The water-permeable sheet 2-1 is permeable through the water-permeable holes 2-1-1 on the water-permeable sheet 2-1, and the water-absorbent sheet 2-2 is made of a water-absorbable material. The propulsion device is used to push the injection substrate 2 to pierce the microneedle into the site to be injected. The dripping device is used to drip water to the injection substrate 2. The aqueous solution passes through the water-permeable sheet 2-1 of the injection substrate 2 and is absorbed by the water-absorbing sheet 2-2. The water-absorbing sheet 2-2 The absorbed aqueous solution quickly dissolves the microneedle base of the microneedle film 1, thereby separating the microneedles piercing the skin from the upper microneedle base, so that the microneedles remain in the skin and precisely release the soluble amount of medicine.

The permeable sheet 2-1 is screw-connected and fixed with the push rod 3.

The propulsion device includes a push rod 3, an outer sleeve 5, a power spring 6 and an injection switch mechanism. The push rod 3 is located in the outer sleeve 5. The push rod 3 is locked in the initial position by the injection switch mechanism. By operating the injection switch mechanism, the push rod 3 Unlocking, the push rod 3 descends under the action of the power spring 6, and pushes the injection substrate 2 to pierce the microneedle into the site to be injected.

The injection switch mechanism includes a switch holder 7 fixed to the inner wall of the outer casing 5, a switch buckle 8 and an unlocking mechanism on the push rod 3, and when the push rod 3 rises to the initial position, the switch buckle 8 of the push rod 3 is stuck The switch holder 7 locks the push rod 3 at the initial position, and the outer sleeve 5 has an unlocking mechanism, which pushes the switch buckle 8 to disengage from the switch holder 7, so that the push rod 3 is unlocked.

The unlocking mechanism is the side button 9 on the side of the outer casing 5. The setting position and quantity of the side button 9 are consistent with the position and quantity of the switch buckle 8. By pressing the side button 9, the inner end of the side button 9 acts on the switch from outside to inside. On the outside of the buckle 8, push the switch buckle 8 to deform inward until it breaks away from the switch holder 7. Specifically, the side button 9 is a structurally separated part of the side wall of the outer sleeve 5, and only the upper part of the side button is connected with the body of the outer sleeve 5, so that the side button can be elastically reset.

The dripping device includes a water storage container 4-2 and a piston 4-3 in the water storage container 4-2, the piston 4-3 is specifically an annular rubber piston, and the water storage container 4-2 and the piston 4-3 are sleeved on the push rod 3 , the inner cavity of the water storage container 4-2 communicates with the push rod channel 3-1 of the push rod 3 through the fluid channel, the water storage container 4-2 is fixedly matched with the push rod 3, and the piston 4-3 is slidably matched with the push rod 3, The piston 4-3 faces the injection substrate 2, and the inner wall of the outer sleeve 5 has a piston pusher 12 protruding upwards. The piston pusher 12 is located below the piston 4-3. When the push rod 3 descends under the action of the power spring 6 , The piston pusher 12 plays a blocking role on the piston 4-3, and pushes the piston 4-3 to pump out the aqueous solution.

The power spring 6 is sleeved on the push rod 3, and the switch buckle 8 is located at the position where the middle part of the push rod 3 leans.

The water storage container 4-2 has a water filling hole 13 and a safety sealing rod 14, and the end of the safety sealing rod 14 is inserted into the push rod passage 3-1, and the water storage container 4-2 is sealed and isolated from the push rod passage 3-1. When injecting the microneedle, pull out a section of safety sealing rod 14, so that the fluid channel communicates with the push rod channel 3-1, and is in the state to be injected. During the pushing process of the power spring 6, the aqueous solution is pressed into the push rod channel 3-1. 1. Send to injection substrate 2.

Embodiment 3, as shown in Figures 3, 4, 5, 6, 7, 8 and 9:

A dissolvable microneedle injection device, including a propulsion device, an injection substrate 2 and a dripping device, the injection substrate 2 is used to fix a microneedle film 1 for injection, the microneedle film 1 includes a microneedle base and microneedles on the microneedle base, The microneedle film 1 is fixed on the back of the injection substrate 2, and the injection substrate 2 is composed of a water-permeable sheet 2-1 alone, and the water-permeable sheet 2-1 is permeable through the water-permeable holes 2-1-1 on the water-permeable sheet 2-1. The front and back of the water permeable sheet 2-1 have a flow diversion channel 2-1-2 communicating with the water permeable hole 2-1-1, which evenly guides the aqueous solution passing through the water permeable sheet 2-1 to the entire microneedle base. The propulsion device is used to push the injection substrate 2 to pierce the microneedle into the site to be injected, and the dripping device is used to drip water to the injection substrate 2, and the aqueous solution penetrates the injection substrate 2 to dissolve the microneedle base of the microneedle film 1.

The propulsion device includes a push rod 3, an outer sleeve 5, a power spring 6 and an injection switch mechanism. The injection substrate 2 is installed on the front end of the push rod 3, and the push rod 3 has a push rod channel 3-1 leading to the front of the injection substrate 2.

The push rod 3 is located in the outer casing 5, and the push rod 3 is locked at the initial position by the injection switch mechanism. By operating the injection switch mechanism, the push rod 3 is unlocked, and the push rod 3 descends under the action of the power spring 6, pushing the injection substrate 2 to the Microneedles are inserted into the site to be injected.

The injection switch mechanism includes a switch holder 7 fixed to the inner wall of the outer casing 5, a switch buckle 8 and an unlocking mechanism on the push rod 3, and when the push rod 3 rises to the initial position, the switch buckle 8 of the push rod 3 is stuck The switch holder 7 locks the push rod 3 at the initial position, and the outer sleeve 5 has an unlocking mechanism, which pushes the switch buckle 8 to disengage from the switch holder 7, so that the push rod 3 is unlocked.

The unlocking mechanism is the end button 10 at the rear end of the outer sleeve 5. The top button is inserted into the rear end of the outer sleeve 5. The bottom of the top button has a lower edge protruding downward. By pressing the end button 10 downward, the end button The lower edge of the button 10 acts on the outside of the switch buckle 8 from top to bottom, pushing the switch buckle 8 to deform inwardly until it breaks away from the switch holder 7 .

For the convenience of assembly, the outer sleeve 5 is arranged as upper and lower sections, and the upper and lower sections are snap-connected by the buckle connection structure of the connection end, and of course can also be connected by a threaded structure.

As shown in Figure 7, the dripping device is a telescopic corrugated drip tube, including a water storage container 4-2 and a drip tube 4-1 at the bottom of the water storage container 4-2, and the water storage container 4-2 with a telescopic corrugated structure can be compressed and deformed , the drip tube is inserted into 4-1 of the push rod channel 3-1, the outlet end of the drip tube 4-1 is located above the injection substrate 2, and the drip device pumps out the water storage container 4-2 by compressing the water storage container 4-2 2, the pumped aqueous solution is injected to the front of the injected substrate 2 through the drip tube 4-1.

In order to allow the aqueous solution not to flow out easily when the water storage container 4-2 is not squeezed, the water outlet end of the drip pipe 4-1 is blocked by an elastic flap, so that the water outlet is in a normally closed state, and the elastic flap is in the pumped aqueous solution. The pressure is pushed away, so that the aqueous solution flows out through the water outlet. The scheme for forming the elastic flaps is: the water outlet end of the drip pipe 4-1 is closed, and the sealing surface is divided into multiple elastic flaps by crossing dividing lines. The crossing dividing line is specifically two dividing lines crossing each other.

The water storage container 4-2 of the dripping device can also be made of elastic material or other elastic structures. In order to allow the aqueous solution not to flow out easily when the water storage container 4-2 is not squeezed, the dripping pipe 4-1 can also adopt a water outlet with a smaller diameter.

The water storage container 4-2 is arranged below the end button 10. When the end button 10 is pressed down to unlock the push rod 3, the end button 10 compresses the water storage container 4-2 to pump out the aqueous solution.

The side of outer sleeve 5 also has movable pusher 11, and movable pusher 11 can be assembled on the outer sleeve 5 movable up and down, and the inner end of movable pusher 11 acts on the push rod 3, moves upward by operating movable pusher 11, Make the inner end of the movable pusher 11 drive the push rod 3 to overcome the spring force of the power spring 6 and move downward until the switch buckle 8 of the push rod 3 blocks the switch holder 7 .

Specifically, in this embodiment, there are two movable push pieces 11, which are symmetrically arranged on the outer sleeve 5, and the side walls of the outer sleeve 5 and the push rod 3 are provided with chutes for installing the movable push pieces 11. The inner end of the push piece 11 has a buckle, and the buckle is stuck on the inner wall of the chute of the push rod 3 to realize the installation of the movable push piece 11 . By operating the movable pusher 11 to move upwards, the top of the inner end of the movable pusher acts on the upper end of the chute of the push rod 3, driving the push rod 3 to overcome the spring force of the power spring 6 and move downward.

In order to facilitate the reset of the movable pusher 11, a spring can be arranged between the outer casing 5 and the push rod 3, and after the movable pusher 11 pushes the push rod 3 to lock, it is reset by the spring. The water storage container 4-2 of the present embodiment 3 has a certain elasticity, which can help the end button 10 to reset. Of course, a spring can also be designed to reset by the spring.

The microneedle injection process is:

Press the upper end button 10 to unlock the push rod 3, and the power spring 6 pushes the push rod 3 to pierce the microneedles of the microneedle film 1 into the skin; at the same time, the end button 10 squeezes the water storage container of the telescopic corrugated dropper 4-2, the aqueous solution breaks the elastic flap of the drip tube 4-1, flows out from the water outlet end of the drip tube 4-1, and sprays on the injection substrate 2, and the injection substrate 2 quickly dissolves the microneedle substrate bonded to it, and the microneedles After the needle base is dissolved, the microneedle pierced into the skin is separated from the microneedle base, so that the microneedle stays in the skin to dissolve and release the drug.

Embodiment 4, as shown in Figures 10, 11, 12, 13, 14, 15 and 16:

A dissolvable microneedle injection device, the difference between Embodiment 4 and Embodiment 3 is that the dripping device includes a water storage container 4-2 and a stabbing rod 4-4, and the water storage container 4-2 has a pierceable seal The upper and lower ports closed by the membrane 4-5, the water dripping device pierces the sealing film 4-5 of the upper and lower ports of the water storage container 4-2 from top to bottom through the thorn bar 4-4 to make the water storage container 4-2 The aqueous solution flows out.

The thruster 4-4 is inserted into the push rod channel 3-1, the rear end of the thruster 4-4 is connected to the end button 10, the water storage container 4-2 is located at the bottom of the push rod channel 3-1, and the end is pressed down When the button 10 unlocks the push rod 3, the end button 10 drives the stabbing rod 4-4 to pierce the sealing film 4-5 of the upper and lower ports of the water storage container 4-2 from top to bottom, so that the water storage container 4-2 The aqueous solution flows out. Sealing film 4-5 can specifically adopt aluminum foil paper. The sealing film 4-5 is only shown in FIG. 11, and the sealing film 4-5 is not shown in other figures.

The injection substrate 2 includes a water-permeable sheet 2-1 and a water-absorbing sheet 2-2, the water-permeable sheet is a hard plastic sheet with a thickness of 1mm, and the water-absorbing sheet 2-2 is made of polyvinyl acetate water filter membrane.

There is a large-diameter permeable hole in the center of the permeable sheet 2-1, and a protruding bowl-shaped support portion is provided on the permeable hole, and the water storage container 4-2 is supported above the water-permeable opening through the bowl-shaped support portion. The back of the water storage substrate has a diversion channel 2-1-2, which evenly guides the aqueous solution to the entire back.

Because the permeable holes of the water-permeable sheet 2-1 are relatively large in diameter, the water-absorbent sheet 2-2 can be omitted only on the premise that the strength of the microneedle base of the microneedle film 1 is sufficient.

For the convenience of assembly, the outer sleeve 5 is set as two upper and lower sections, and the upper and lower sections are connected by the threaded structure on the connecting end.

Movable push piece 11 is cylindrical, is enclosed within on the push rod 2, and outer casing 5 side walls have chute, and the operation button on the outer wall of movable push piece 11, operation button is exposed through chute, convenient to operate, on push rod 3 There is a protruding ring 15 on the top, and the movable pusher 11 acts on the protruding ring 15 to drive the push rod 3 to overcome the spring force of the power spring 6 and move downward. In order to help the end button 10 reset, a spring is designed in the outer sleeve 5, and the end button 10 is reset by the spring. For making things easier for the stabbing rod 4-4 to reset, a spring for resetting the stabbing rod 4-4 is sleeved on the stabbing rod 4-4.

The microneedle injection process is:

Press the upper end button 10 to unlock the push rod 3, and the power spring 6 pushes the push rod to pierce the microneedle of the microneedle film 1 into the skin; at the same time, the end button 10 drives the stabbing rod 4-4 to pierce from top to bottom. Wear the sealing film 4-5 of the upper and lower ports of the water storage container 4-2, so that the aqueous solution in the water storage container 4-2 flows out and sprays on the injection substrate 2, and the injection substrate 2 quickly absorbs water and dissolves the microneedle base bonded to it After the microneedle base dissolves, separate the microneedle pierced into the skin from the microneedle base, so that the microneedle stays in the skin to dissolve and release the drug.

Claims (13)

1. A dissolvable microneedle injection device, characterized in that it includes a propulsion device, an injection substrate (2) and a dripping device, The injection substrate (2) is used to fix the microneedle film (1) for injection, the microneedle film (1) includes a microneedle base and microneedles on the microneedle base, and the microneedle film (1) is fixed on the injection base (2) On the back, the injected substrate (2) is permeable or absorbent, The propulsion device is used to push the injection substrate (2) to pierce the microneedle into the site to be injected, and the dripping device is used to drip water on the injection substrate (2), and the aqueous solution penetrates to the back of the injection substrate (2) to dissolve the microneedle of the microneedle film (1) The base, or injection base (2) absorbs the aqueous solution to dissolve the microneedle base of the microneedle film (1), thereby separating the microneedles piercing the skin from the microneedle base above, allowing the microneedles to remain in the skin and precisely releasing the soluble solvent amount of drug, The propulsion device includes a push rod (3), the injection substrate (2) is installed at the front end of the push rod (3), and the push rod (3) has a push rod channel (3-1) leading to the front of the injection substrate (2), The dripping device is directly set in the push rod channel (3-1), Alternatively, the dripping device directly uses the push rod channel (3-1) to inject the pumped aqueous solution to the front of the injection substrate (2), Alternatively, the drip device has a drip tube (4-1) inserted into the push rod channel (3-1), the outlet end of the drip tube (4-1) is located above the injection substrate (2), and the pumped aqueous solution passes through the drip tube (4-1) Inject toward the front side of the injection substrate (2). 2. The dissolvable microneedle injection device according to claim 1, characterized in that: the injection substrate (2) is composed of a water-permeable sheet (2-1) or a water-absorbent sheet (2-2) alone, and the water-permeable sheet ( 2-1) Permeate water through the permeable holes (2-1-1) on the permeable sheet (2-1), and the water-absorbing sheet (2-2) is made of water-absorbable material, Alternatively, the injection substrate (2) is a combination of a water-permeable sheet (2-1) and a water-absorbent sheet (2-2), and the water-absorbent sheet (2-2) is located on the back of the water-permeable sheet (2-1). 3. The dissolvable microneedle injection device according to claim 2, characterized in that: the back of the water-permeable sheet (2-1), or the front and the back have a hole that communicates with the water-permeable hole (2-1-1). The diversion channel (2-1-2) evenly diverts the aqueous solution passing through the permeable sheet (2-1) to the entire microneedle base. 4. The dissolvable microneedle injection device according to claim 1, characterized in that: the water outlet end of the dripping pipe (4-1) is blocked by an elastic flap, so that the water outlet is in a normally closed state, and the elastic flap The sheet is pushed away by the pressure of the pumped aqueous solution, so that the aqueous solution flows out through the water outlet, or, the water outlet of the dripping pipe (4-1) adopts a water outlet with a smaller diameter. 5. The dissolvable microneedle injection device according to claim 1, characterized in that: the dripping device includes a water storage container (4-2) and a piston (4-3) inside the water storage container (4-2). ), the dripping device pumps out the aqueous solution in the water storage container (4-2) through the piston (4-3); Alternatively, the dripping device includes a water storage container (4-2), the water storage container (4-2) can be compressed and deformed, and the dripping device pumps out the water storage container (4-2) by compressing the water storage container (4-2). -2) in aqueous solution; Alternatively, the dripping device includes a water storage container (4-2) and a thorn bar (4-4), and the water storage container (4-2) has an upper, For the lower port, the dripping device pierces the sealing film (4-5) of the upper and lower ports of the water storage container (4-2) from top to bottom through the thorn rod (4-4) so that the water storage container (4-2) The aqueous solution flows out. 6. The dissolvable microneedle injection device according to claim 5, characterized in that: the propulsion device also includes an outer casing (5), a power spring (6) and an injection switch mechanism, and the push rod (3) is located in the outer casing Inside the tube (5), the push rod (3) is locked in the initial position by the injection switch mechanism. By operating the injection switch mechanism, the push rod (3) is unlocked, and the push rod (3) descends under the action of the power spring (6). Push the injection substrate (2) to pierce the microneedle into the site to be injected, The dripping device completes the dripping action with the help of the power of the power spring (6), or the dripping device completes the dripping action with the help of the operating force of the injection switch mechanism. 7. The dissolvable microneedle injection device according to claim 6, characterized in that: the injection switch mechanism includes a switch holder (7) fixed to the inner wall of the outer sleeve (5), a push rod (3) With switch clasp (8) and unlocking mechanism, When the push rod (3) rises to the initial position, the switch buckle (8) of the push rod (3) locks the switch holder (7), and the push rod (3) is locked at the initial position, and the outer tube (5) It has an unlocking mechanism, and the unlocking mechanism pushes the switch buckle (8) out of the switch holder (7), so that the push rod (3) is unlocked. 8. The dissolvable microneedle injection device according to claim 7, characterized in that: the unlocking mechanism is a side button (9) on the side of the outer cannula (5), and the setting position and number of the side buttons (9) are the same as The position and quantity of the switch buckles (8) are the same. By pressing the side button (9), the inner end of the side button (9) acts on the outside of the switch buckle (8) from the outside to the inside, and pushes the switch buckle (8) Deform it inward until it disengages from the switch holder (7). 9. The dissolvable microneedle injection device according to claim 7, characterized in that: the unlocking mechanism is an end button (10) at the rear end of the outer cannula (5), and the top button is inserted into the outer cannula (5) The lower part of the top button has a downward protruding lower edge. By pressing the end button (10) downward, the lower edge of the end button (10) acts on the switch buckle (8) from top to bottom. ), push the switch buckle (8) to deform inward until it breaks away from the switch holder (7). 10. The dissolvable microneedle injection device according to claim 6, characterized in that: when the dripping device includes a water storage container (4-2) and a piston (4-3) in the water storage container (4-2) , The water storage container (4-2) and the piston (4-3) are sleeved on the push rod (3), and the inner cavity of the water storage container (4-2) is connected with the push rod channel (3-1) of the push rod (3) In communication, the water storage container (4-2) is fixedly fitted with the push rod (3), the piston (4-3) is slidably fitted with the push rod (3), the piston (4-3) faces the injection substrate (2), and the outer sleeve ( 5) has an upwardly protruding piston pusher (12) on the inner wall, and the piston pusher (12) is located below the piston (4-3), when the push rod (3) descends under the action of the power spring (6) , the piston pusher (12) blocks the piston (4-3), and pushes the piston (4-3) to pump out the aqueous solution. 11. The dissolvable microneedle injection device according to claim 9, characterized in that: when the dripping device is a compressible deformable water storage container (4-2), the water storage container (4-2) is arranged at the end Below the button (10), when the top button is pressed down to unlock the push rod (3), the end button (10) compresses the water storage container (4-2) to pump out the aqueous solution; Or, when the dripping device includes a water storage container (4-2) and a stabbing rod (4-4), the stabbing rod (4-4) is inserted into the push rod channel (3-1), and the back of the stabbing rod (4-4) The end is connected with the end button (10), and the water storage container (4-2) is located at the lower part of the push rod channel (3-1). When the end button (10) is pressed down to unlock the push rod (3), the end The button (10) drives the thorn bar (4-4) to pierce the sealing film (4-5) of the upper and lower ports of the water storage container (4-2) from top to bottom, so that the water storage container (4-2) The aqueous solution flows out. 12. The dissolvable microneedle injection device according to claim 6 or 7 or 8 or 9 or 10 or 11, characterized in that: the side of the outer cannula (5) also has a movable pusher (11), the movable The push piece (11) can be assembled on the outer casing (5) up and down. The inner end of the movable push piece (11) acts on the push rod (3). By operating the movable push piece (11) to move upward, the movable push piece The inner end of the piece (11) drives the push rod (3) to overcome the spring force of the power spring (6) and move downward until the switch buckle (8) of the push rod (3) blocks the switch holder (7). 13. The dissolvable microneedle injection device according to claim 1, characterized in that: the aqueous solution is a pure aqueous solution, or the aqueous solution is a pharmaceutical aqueous solution containing pharmaceutical components, or the aqueous solution is a cosmetic aqueous solution containing cosmetic components.