CN112155830A

CN112155830A - Drug-loaded micro-needle small splint and using method thereof

Info

Publication number: CN112155830A
Application number: CN202010898952.5A
Authority: CN
Inventors: 王成勇; 张智雷; 郭紫莹; 刘志华
Original assignee: Guangdong University of Technology
Current assignee: Guangdong University of Technology
Priority date: 2020-08-31
Filing date: 2020-08-31
Publication date: 2021-01-01

Abstract

The invention provides a drug-loaded micro-needle splint and a using method thereof, and the drug-loaded micro-needle splint comprises a fixing part, a fitting part and a micro-needle layer; the fixing part is connected with the attaching part, the attaching part is fixedly connected with the microneedle layer, and microneedles are symmetrically arranged on the microneedle layer; the microneedles carry a drug layer thereon; the using method comprises the steps of carrying out scanning modeling on the reduced fracture affected limb of a patient to obtain the treatment size; selecting a micro-needle type; taking out the corresponding fixing part and the microneedle layer according to the size requirement; when the affected limb is treated, firstly, a joint part is printed out according to modeling to form a complete micro-needle small splint; finally, the small splint is pressed on the set treatment position, and is bound and fixed to finish the primary treatment. The invention adopts the modularized and personalized design, has the advantages of good drug treatment effect, comfort and ventilation and convenient drug change, and is a drug-loaded micro-needle splint which is particularly suitable for treating fracture.

Description

Drug-loaded micro-needle small splint and using method thereof

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a drug-loading micro-needle splint and a using method thereof, in particular to a drug-loading micro-needle splint for treating fracture.

Background

The traditional Chinese medicine splint is a thin plate used for fixing fracture parts in closed fracture treatment, is commonly used for fracture types such as forearm radius fracture, ulna fracture and the like, and is made of fir bark, willow or plywood and the like. The use of the existing small splint: (1) firstly, winding the gauze soaked with the medicine; (2) clamping and fixing by using a clamping plate; (3) tightly winding and binding by using gauze and the like; (4) the medicine soaking gauze and the bandage are worn for a long time and replaced regularly.

The existing small splint has the following problems: (1) the medicine is inconvenient to apply or replace, the medicine can be applied or replaced only by disassembling the splint, the release rate and the release amount of the medicine cannot be controlled, and the medicine absorption effect is poor; the medicine is attached between the splint and the skin for a long time, and complications such as eczema and the like are easy to generate; (2) poor air permeability, uncomfortable wearing and not beneficial to tissue recovery; (3) the fitting performance is poor, the limb type of each person cannot be adapted, and the affected limb is locally stressed, so that the fixing effect is poor; (4) the splint can not adapt to the thickness change of the affected limb caused by the elimination or the enlargement of swelling, the change of actions and the like, and the effect of fracture fixation can not be achieved. Aiming at the problems, a drug-loaded micro-needle splint is provided.

Disclosure of Invention

In view of the above, the invention provides a drug-loaded micro-needle splint and a use method thereof, the invention adopts a modularized and personalized design, has the advantages of good drug treatment effect, comfort and ventilation and convenient drug change, and is a drug-loaded micro-needle splint particularly suitable for fracture treatment.

The technical scheme of the invention is as follows:

a drug-loaded micro-needle splint is characterized by comprising a fixing part, a fitting part and a micro-needle layer; the fixing part is connected with the attaching part, the attaching part is fixedly connected with the microneedle layer, and microneedles are symmetrically arranged on the microneedle layer; the microneedles carry a drug layer.

Further, the micro-needle is any one or a composite of several of a hollow micro-needle, a soluble micro-needle, a coated micro-needle and a hydrogel micro-needle.

Further, the length of the micro-needle is 1000-2000 μm, the diameter of the substrate is 100-500 μm, the taper of the needle tip is 5-15 degrees, and the center distance of the needle is 200-1000 μm. In the present invention, the length of the microneedle can be selected according to the treatment requirement, the diameter of the substrate is generally related to the length of the microneedle, and the larger diameter of the substrate is generally selected for the longer microneedle. The microneedle layer microneedle is loaded with a drug layer. The microneedle can deliver the medicine into the dermis layer through the epidermis, is beneficial to the absorption of the medicine by the subcutaneous tissue, and promotes hemostasis, blood stasis removal, healing and growth. The microneedle drug-carrying can send the drug into the skin, greatly improve the drug absorption efficiency, and has the effect of drug slow release and improved treatment effect.

Further, the drug layer comprises, but is not limited to, analgesic drugs, growth promoting and healing promoting drugs, and blood stasis removing drugs, such as growth promoting and healing traumatology yellow water, salvia miltiorrhiza and ligustrazine, blood stasis removing and pain relieving rhubarb, mirabilite, borneol, turmeric, peach kernel, safflower, ground beetle, frankincense, and the like, and can be a compound of several drugs. According to the invention, the drug can be delivered into the skin through microneedle drug loading, so that the drug absorption efficiency is greatly improved, and the drug sustained-release effect and the treatment effect are improved.

Further, the shape of the base of the microneedle includes, but is not limited to, circular, square, triangular, diamond, oval.

Further, the microneedle is a hollow microneedle, a drug storage bin and a drug outlet hole which are mutually communicated are arranged on the hollow microneedle, the drug storage bin is used for storing drugs, and the drug is discharged from the small hole of the drug outlet hole to form a drug slow release effect.

Furthermore, the side of the hollow microneedle is provided with a drug inlet hole, so that multiple times of drug delivery can be realized, and continuous treatment is facilitated.

Further, the microneedle is a soluble microneedle, the needle point of the soluble microneedle is a combination of a drug and a polymer, and the polymer comprises any one of polylactic acid, chondroitin sulfate, polyvinyl alcohol and dextran.

Furthermore, the microneedle layer is symmetrically distributed with air holes for ventilation.

Furthermore, the fixing part is of a flat arch structure, the affected limb is of a cylindrical structure, and the splint has a certain radian and can better fit the affected limb; the upper end of the fitting part is in a flat arch shape, the lower end of the fitting part is in an artificial affected limb structure, and the artificial affected limb structure is in a personalized structure and is different according to the different shapes of each affected limb; the micro-needle layer is arranged on the surface of the lower end of the fitting part, so that the limb can be conveniently fitted, the fitting part is matched with the personalized fitting part, pressure can be adapted along with pressure change caused by swelling degree of the limb, and the condition that the limb is pressed is guaranteed to be unchanged.

Further, fixed part and laminating portion are through the cooperation of prior art's draw-in groove, and laminating portion and micropin layer are through pasting the cooperation. Through the arrangement, the fixing part can be conveniently detached and reused, the microneedle layer can flexibly adapt to the shape of the attaching part, and the microneedle layer is convenient to replace.

Furthermore, the fixing part is provided with first through holes, and the attaching part is provided with second through holes for ventilation. The first through holes are in any one of a circular shape, a quadrilateral shape and a honeycomb shape; the shape of the second through hole is any one of circular, quadrilateral and honeycomb.

Further, the dimensions of the fixing portion and the attaching portion are as follows: the thickness is 2-10mm, the length is 150-200mm, the width is 50-100mm, in the invention, the thickness is enough, and the mechanical property is better; the length and the width need to be matched with the length and the width of the affected limb, the too short fixation effect is poor, and the too long fixation can affect the movement of other parts and cause discomfort; the thickness can be selected according to different people, for example, the thickness is smaller when the bone is growing like children, and the thickness is larger for adults.

Furthermore, the thickness of the joint part close to the wrist end is larger than that of the arm end, the thickness is enough, and the mechanical property is better.

Further, the attaching portion is a polymer attaching portion.

Further, the fixing portion is any one of a polymer attaching portion, a metal attaching portion, and a wood attaching portion.

The invention also provides a use method of the drug-loaded micro-needle splint, which is characterized by comprising the following steps: firstly, scanning and modeling the reduced fracture affected limb of a patient to obtain a treatment size; the microneedle layer is prepared and stored in advance, and the type of the microneedle is selected according to the treatment requirement; taking out the corresponding fixing part and the microneedle layer according to the size requirement; when the affected limb is treated, firstly, the joint part is printed according to modeling, then the fixing part is matched with the joint part through the clamping groove, and then the upper part of the microneedle layer is stuck on the lower layer surface of the joint part to keep the structure of the imitated affected limb, so that a complete microneedle small splint is formed; finally, the small splint is pressed on the set treatment position, and is bound and fixed to finish the primary treatment.

When changing the medicine, the small splint is dismounted, and the microneedle is moved out; if soluble microneedles are used, the microneedle part is dissolved, so that a new microneedle layer is only needed to be attached to the lower layer surface of the attaching part, and the method is convenient and quick.

The invention adopts the modularized and personalized design, has the advantages of good drug treatment effect, comfort and ventilation and convenient drug change, and is a drug-loaded micro-needle splint which is particularly suitable for treating fracture.

The invention has the beneficial effects that:

1. the drug treatment effect is good, the drug is sent into the skin through the micro-needle, the drug absorption efficiency can be greatly improved by matching with the slow release effect of the micro-needle, no pain is caused, the drug replacement is convenient, different drugs can be configured according to the treatment stage, the humidity is reduced, and complications such as erythema and the like are reduced.

2. The medicine changing is convenient, namely when the medicine is changed, the microneedle layer is only required to be torn off and then the prepared microneedle layer is attached, the time consumption of the whole process is not more than half a minute, and a clamp plate is not required to be cleaned, so that the medicine changing is convenient and fast.

3. The modular design-reduces the manufacturing time, and the standard part is fixed part 1 and microneedle layer 3, and these two parts adopt the mode of volume production, prepare in advance and preserve, can directly take out the fixed part 1 and the microneedle layer 3 of corresponding size during the treatment, reach the effect of save time.

4. individuation-3D printing can be rapidly formed, and the individuation requirement is met; meanwhile, due to the personalized design, the stress distribution is uniform when the splint is fixed, the splint is comfortable to wear, the fixation is more stable, and the bone growth and healing are supported.

The elasticity of the material is good, and when the affected limb swells, excessive pressure cannot be generated.

5. Breathable-comfortable to wear.

Drawings

FIG. 1 is a schematic structural view of the present invention;

FIG. 2 is a schematic structural view of a use state of the present invention;

FIG. 3 is a partial schematic view of the present invention;

FIG. 4 is a partial schematic view of the present invention;

FIG. 5 is a partial schematic view of the present invention;

fig. 6 is a schematic view of a hollow microneedle structure according to an embodiment of the present invention;

fig. 7 is a schematic view of a hollow microneedle structure according to an embodiment of the present invention;

fig. 8 is a schematic view of a soluble microneedle structure according to an embodiment of the present invention;

fig. 9 is a schematic view of a coated microneedle structure according to an embodiment of the present invention;

fig. 10 is a schematic view of a hydrogel microneedle structure according to an embodiment of the invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

As shown in fig. 1-5, fig. 8. A medicine carrying micro-needle splint comprises a fixing part 1, a fitting part 2 and a micro-needle layer 3. Firstly, scanning and modeling the restored affected limb of the patient to obtain a surface model of the affected limb, framing a treatment area, and determining the size of the selected small splint. The microneedle layer 3 is prepared into a standard part before treatment, is a soluble microneedle 33, is made of hyaluronic acid, and is a wound yellow water for promoting growth and healing; compared with the traditional method that the gauze is soaked in the yellow water and then wound and applied on the affected part, the method can cause the medicine to be fast lost, high in humidity and poor in absorption. The soluble microneedle mixes the yellow water and the hyaluronic acid, the medicament is delivered into the interior through the epidermal layer, the medicament is well absorbed, the medicament can be fully absorbed by tissues due to low solid humidity and slow release, and the medicament is mixed with the hyaluronic acid in advance and then prepared into the microneedle; the thickness of the microneedle array is 2mm, the shape of the microneedle substrate is circular, the diameter of the substrate is 0.1mm, the length of the substrate is 0.5mm, and the distance between needles is 0.5 mm; the large circular through holes 31 are distributed on the base plate, the aperture is 20mm, and the distance is 60 mm. The fixing part 1 is prepared into a standard component in a large quantity before treatment, the material is polymer so as to be convenient to take and use at any time, and the fixing part matched with the size of a patient is selected according to the requirement of the patient during treatment; the both ends have symmetrical draw-in groove structure, and the draw-in groove width is 2mm, and the degree of depth is 2mm, and fixed part 1 is gone up to distribute has first through-hole 11, and the aperture is 10mm, and the interval is 30 mm. Laminating portion 2 prints through 3D and makes, and its size keeps unanimous with the fixed part of chooseing for use, and the material is the polymer, and both ends have become the draw-in groove structure, and the draw-in groove width is 2mm, highly is 2mm, and it has second through-hole 21 to distribute on laminating portion 2, and the aperture is 10mm, and the interval is 30mm, and the distribution is unanimous with fixed part 1.

The using method comprises the following steps: firstly, scanning and modeling the reduced fracture affected limb of the patient to obtain the treatment size. The microneedle layer 3 is prepared and stored in advance, and soluble microneedles are selected according to treatment requirements. And taking out the corresponding fixed part 1 and the microneedle layer 3 according to the size requirement. When the affected limb is treated, the joint part 2 is printed out according to modeling, the fixing part 1 is matched with the joint part 2 through the clamping groove, the upper part of the microneedle layer is attached to the lower layer 22 surface of the joint part 2, the imitated affected limb structure is kept, and the whole microneedle small splint is formed. Finally, the small splint is pressed on the set treatment position, and is bound and fixed to finish the primary treatment. When changing dressings, lift off the splint, because the use is soluble micropin, micropin portion has dissolved this moment, consequently only need with new micropin layer 3 attached on the lower floor 22 face of laminating portion 2 can, convenient and fast.

Example 2

As shown in fig. 1-7. A medicine carrying micro-needle splint comprises a fixing part 1, a fitting part 2 and a micro-needle layer 3. Firstly, scanning and modeling the restored affected limb of the patient to obtain a surface model of the affected limb, framing a treatment area, and determining the size of the selected small splint. The microneedle layer 3 is a hollow microneedle which is prepared into a standard part through 3D printing before treatment, and meanwhile, the medicines are combined medicines of rheum officinale, mirabilite, borneol, turmeric, peach kernel, safflower, ground beeltle and frankincense, which are used for removing blood stasis and relieving pain, and are filled into a medicine storage bin; compared with the traditional method that the medicine is soaked in gauze and then wound and applied to the affected part, the method can cause quick medicine loss, high humidity and poor absorption. The hollow microneedle stores the medicine in a medicine storage bin in advance, penetrates into skin through a skin layer, feeds the medicine into a body through the small hole 322, is well absorbed, can be fully absorbed by tissues due to low solid humidity and slow release, is made of biocompatible resin, has the thickness of 3mm, the wall thickness of the medicine storage bin 31 is 0.5mm, the shape of the microneedle substrate is circular, the diameter of the substrate is 0.5mm, the length is 1.5mm, the diameter of the medicine outlet hole 32 is 0.3mm, and the distance between needles is 1 mm; it is provided with larger circular through holes 31 with the aperture of 20mm and the interval of 60mm, and the side edge is provided with medicine inlet holes 323 with the aperture of 1 mm. The fixing part 1 is prepared into a standard part in a large quantity by a machining method before treatment, the standard part is made of wood and is convenient to take and use at any time, and the fixing part matched with the size of a patient is selected according to the requirement of the patient during treatment; the two ends of the clamping groove are provided with symmetrical clamping groove structures, the width of each clamping groove is 2mm, the depth of each clamping groove is 2mm, first through holes 11 are distributed, the aperture of each through hole is 15mm, and the distance between the first through holes and the corresponding through holes is 45 mm. The laminating portion 2 is at first scanned the modeling to the affected limb that the patient has reset, obtains affected limb surface model, and the frame is decided the treatment region, prints through 3D and makes, and its size keeps unanimous with the fixed part of choosing for use, and the material is the resin, and both ends have to become the draw-in groove structure, and the draw-in groove width is 2mm, and highly is 2mm, and it has second through-hole 21 to distribute on the laminating portion 2, and the aperture is 15mm, and the interval is 45mm, and the distribution is unanimous with fixed part 1.

The using method comprises the following steps: firstly, scanning and modeling are carried out on the reduced fracture affected limb of the patient, a three-dimensional model of the affected limb is obtained, and preparation is prepared for preparing the joint part 2. The fixing part 1 and the micro needle layer 3 are standard products which are prepared and stored, and the fixing part 1 and the micro needle layer 3 which correspond to each other are selected and taken out according to the treatment size of the affected limb of a patient and the required medicine, so that the treatment time is greatly shortened. When a patient is treated, the joint part 2 is printed out according to modeling, the fixing part 1 and the joint part 2 are matched through the clamping groove, the upper part of the microneedle layer is attached to the lower layer 22 surface of the joint part 2, the affected limb imitating structure is kept, and the whole microneedle small splint is formed. Finally, the small splint is pressed on the set treatment position, and is bound and fixed to finish the primary treatment. When changing medicine, the medicine is inserted into the medicine inlet hole 323 through the needle point with the diameter less than 1mm, and the changed medicine is sent into the medicine storage bin through the needle point; or the splint can be detached, the microneedle layer 3 is torn down, and the new microneedle layer 3 which needs to use the medicine is taken out and directly attached.

Example 3

A drug-loaded micro-needle splint is characterized by comprising a fixing part 1, a fitting part 2 and a micro-needle layer 3; the fixing part is connected with the attaching part, the attaching part is fixedly connected with the microneedle layer, and microneedles are symmetrically arranged on the microneedle layer; the microneedles carry a drug layer (341) thereon.

Further, the microneedles are coated microneedles 34.

Further, the length of the micro-needle is 1200 μm, the diameter of the base is 240 μm, the taper of the needle tip is 11.3 degrees, and the distance between the centers of the needles is 400 μm.

Further, the medicine layer is a mixture of growth-promoting healing traumatology yellow water and hyaluronic acid.

Further, the shape of the base of the microneedle is square.

Further, the microneedle layer is symmetrically distributed with air holes 31 for ventilation.

Furthermore, the fixing part is distributed with first through holes 11, and the attaching part is distributed with second through holes 21 for ventilation. The first through hole is circular; the second through hole is circular in shape.

Further, the dimensions of the fixing portion and the attaching portion are as follows: the thickness is 5mm, the length is 160mm, and the width is 60 mm.

Further, the attaching portion is a polymer attaching portion.

Further, the fixed part is a polymer attaching part.

When changing dressings, lift off the splint, shift out the micropin, with new micropin layer paste on the lower aspect of laminating portion can, convenient and fast.

Example 4

A drug-loaded micro-needle splint is characterized by comprising a fixing part 1, a fitting part 2 and a micro-needle layer 3; the fixing part is connected with the attaching part, the attaching part is fixedly connected with the microneedle layer, and microneedles are symmetrically arranged on the microneedle layer; the microneedles carry a drug layer (351) thereon.

Further, the microneedles are hydrogel microneedles 35.

Further, the length of the microneedle is 1500 μm, the diameter of the base is 200 μm, the taper of the needle tip is 7.6 degrees, and the distance between the centers of the microneedles is 800 μm.

Further, the medicine layer is a mixed liquid medicine of rhubarb, mirabilite, borneol, turmeric, peach kernel, safflower, ground beetle and frankincense which can remove blood stasis and relieve pain.

Further, the shape of the base of the microneedle is circular.

Furthermore, the fixing part is distributed with first through holes 11, and the attaching part is distributed with second through holes 21 for ventilation. The first through holes are honeycomb-shaped; the second through holes are honeycomb-shaped.

Further, the dimensions of the fixing portion and the attaching portion are as follows: the thickness is 8mm, the length is 180mm, and the width is 80 mm.

Further, the attaching portion is a polymer attaching portion.

Further, the fixing part is a wood attaching part.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art. It should be noted that the technical features not described in detail in the present invention can be implemented by any prior art.

Claims

1. A drug-loaded micro-needle splint is characterized by comprising a fixing part, a fitting part and a micro-needle layer; the fixing part is connected with the attaching part, the attaching part is fixedly connected with the microneedle layer, and microneedles are symmetrically arranged on the microneedle layer; the microneedles carry a drug layer.

2. The drug-loaded microneedle mini splint according to claim 1, wherein the microneedles are any one or a combination of hollow microneedles, soluble microneedles, coated microneedles and hydrogel microneedles.

3. The drug-loaded microneedle mini splint according to claim 1, wherein the microneedle length is 1000-.

4. The drug-loaded microneedle mini-splint according to claim 1, wherein the microneedles of said microneedle layer carry a drug layer thereon.

5. The drug-loaded microneedle mini splint according to claim 1, wherein the shape of the base of the microneedles is any one of circular, square, triangular, diamond-shaped, and oval.

6. The drug-loaded microneedle splints according to claim 2, wherein the microneedles are hollow microneedles, and the hollow microneedles are provided with drug storage bins and drug outlet holes which are communicated with each other; the side of the hollow microneedle is provided with a drug inlet hole.

7. The drug-loaded microneedle splint according to claim 2, wherein said microneedles are soluble microneedles, the tips of said soluble microneedles are a combination of a drug and a polymer, said polymer comprises any one of polylactic acid, chondroitin sulfate, polyvinyl alcohol, dextran.

8. The drug-loaded microneedle mini-splint according to claim 1, wherein said fixation portion is a flat arch structure; the upper end of the fitting part is in a flat arch shape, and the lower end of the fitting part is in an artificial affected limb structure; the microneedle layer is arranged on the surface of the lower end of the attaching part.

9. The drug-loaded microneedle mini-splint according to claim 1, wherein the microneedle layer is symmetrically distributed with air holes; the fixing part is distributed with first through holes, the laminating part is distributed with second through holes, and the shape of the through holes comprises any one of a circle, a quadrangle and a honeycomb.

10. A method of using the drug-loaded microneedle mini-splint according to any of claims 1-9, comprising the steps of: firstly, scanning and modeling the reduced fracture affected limb of a patient to obtain a treatment size; the microneedle layer is prepared and stored in advance, and the type of the microneedle is selected according to the treatment requirement; taking out the corresponding fixing part and the microneedle layer according to the size requirement; when the affected limb is treated, firstly, the joint part is printed according to modeling, then the fixing part is matched with the joint part through the clamping groove, and then the upper part of the microneedle layer is stuck on the lower layer surface of the joint part to keep the structure of the imitated affected limb, so that a complete microneedle small splint is formed; finally, the small splint is pressed on the set treatment position, and is bound and fixed to finish the primary treatment.