CN110812686A - Micro-processing technology for manufacturing microneedle array and microneedles - Google Patents
Micro-processing technology for manufacturing microneedle array and microneedles Download PDFInfo
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- CN110812686A CN110812686A CN201911081493.5A CN201911081493A CN110812686A CN 110812686 A CN110812686 A CN 110812686A CN 201911081493 A CN201911081493 A CN 201911081493A CN 110812686 A CN110812686 A CN 110812686A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0046—Solid microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
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Abstract
The invention provides a micro-processing technology for manufacturing a micro-needle array and micro-needles. The process method for monitoring the hole provided by the invention converts the etching of the blind hole into the control of the through hole, only needs to etch the depth of the monitoring hole into the difference value between the thickness of the silicon wafer and the thickness of the long blind hole at the top of the silicon wafer, then when the long blind hole is etched at the bottom of the silicon wafer and the monitoring hole is etched completely from the bottom direction of the silicon wafer, the length of the long blind hole at the moment is indicated to meet the required length, the continuous etching can be stopped, and the length error of the long blind hole can be avoided; according to the composite layer mask process method provided by the invention, the uppermost layer mask and the lowest layer mask are set into different shapes, and a structure is obtained after etching through the upper layer mask; and then removing the upper layer mask, and etching through the lower layer mask to obtain a more complex three-dimensional structure. The liquid medicine outlet of the microneedle is a side outlet, so that the problem that skin tissues block the liquid medicine outlet is avoided; meanwhile, the leakage of the liquid medicine can be prevented.
Description
Technical Field
The invention relates to the technical field of micro-electromechanical systems and biomedical engineering, in particular to a micro-processing technology for manufacturing a micro-needle array and micro-needles.
Background
Currently, in medical transdermal administration applications, transdermal administration using microneedles is a new administration method different from conventional administration methods such as oral administration and subcutaneous injection. Transdermal administration using microneedles can effectively eliminate or reduce the weakness of conventional administration. For example, the oral administration mode may have gastrointestinal first-pass effect, thereby reducing the curative effect; and the injection mode can bring mental distress to patients suffering from needle phobia during administration.
The microneedle form is various, such as a solid microneedle, a hollow microneedle, and the like. The solid micro-needle improves the permeability of the liquid medicine by forming a micro-channel on the skin; the hollow micro-needle can directly convey the liquid medicine to the dermis layer of the skin and enter the systemic circulation of a human body, and the permeability of the liquid medicine is much higher than that of the solid micro-needle. However, hollow microneedles are preferred. The conventional method for processing Hollow microneedles (e.g., Boris Stoeber and Dorian Liepmann, "Arrays of Hollow Out-of-plane micro needles for Drug Delivery", J. MicroElectromech. Syst., 14(3): 472-; in addition, the problem of leakage of the liquid medicine during the delivery process is also considered.
Disclosure of Invention
In order to solve the problem that when the hollow microneedle manufactured by the existing processing method injects liquid medicine, part of skin tissues block the liquid medicine outlet or liquid medicine leaks, the invention provides the micro-processing technology for manufacturing the microneedle array and the microneedle, which can process a sharp needle point and easily penetrate into the skin, and the liquid medicine outlet is a side outlet, so that the problem that the skin tissues block the liquid medicine outlet is avoided. Meanwhile, the leakage of the liquid medicine can be prevented.
The invention provides a micro-processing technology for manufacturing a micro-needle array, which comprises the following steps:
step 1: obtaining a first mask on the top of the silicon wafer through photoetching;
step 2: taking the first mask as a mask, and etching the top of the silicon wafer to obtain a plurality of monitoring holes;
and step 3: obtaining a second mask at the bottom of the silicon wafer through photoetching;
and 4, step 4: a second mask is used as a mask, and a plurality of microneedle hollow cavities are obtained at the bottom of the silicon wafer through isotropic etching; wherein at least one microneedle hollow cavity and a monitoring hole are overlapped at a longitudinal position, so that when the monitoring hole is etched into a through hole from the bottom of a silicon wafer, an isotropic etching process is stopped;
and 5: generating a composite layer mask on the top of the silicon wafer, wherein the composite layer mask comprises at least two layers of masks from top to bottom; between any two adjacent layers of masks, the mask positioned on the upper layer completely covers the mask positioned on the lower layer, and the shapes of the mask on the uppermost layer and the mask on the lowest layer are different;
step 6: forming a microneedle body on the top of the silicon wafer by anisotropic etching by taking the uppermost mask as a mask, and thermally oxidizing the surface of the microneedle body to generate a protective film;
and 7: removing the rest upper-layer masks except the bottommost mask, taking the bottommost mask as a mask, and preliminarily forming a microneedle tip and a prism tip on the top of the silicon wafer through isotropic etching;
and 8: continuously taking the mask at the bottommost layer as a mask, and forming a liquid medicine side outlet at the top of the silicon wafer through anisotropic etching;
and step 9: continuously taking the bottom layer mask as a mask, and finally forming the microneedle tips and the star-shaped prism tips on the top of the silicon wafer through isotropic etching again;
step 10: and removing the bottommost layer mask and the protective film on the surface of the microneedle body to obtain the microneedle array.
Furthermore, a plurality of monitoring holes are uniformly distributed at the top of the silicon wafer, and a plurality of microneedle hollow cavities are uniformly distributed at the bottom of the silicon wafer.
Furthermore, every two microneedle hollow cavities and one monitoring hole form a microneedle group, one microneedle hollow cavity in each microneedle group is located right below the monitoring hole in the group, and the other microneedle hollow cavity and the monitoring hole are not overlapped with each other in the longitudinal position.
Further, the composite layer mask is adjacent to the monitoring hole and located above the microneedle hollow cavity, and the transverse length of the bottommost layer mask is not smaller than the inner diameter of the microneedle hollow cavity.
Furthermore, the uppermost layer mask is circular, and the lowermost layer mask is star-shaped.
The invention also provides a microneedle based on the micro-processing technology, which comprises: the micro-needle comprises a micro-needle body, a micro-needle hollow cavity, a micro-needle point, a prism tip and a liquid medicine outlet, wherein the liquid medicine outlet is a side outlet.
The invention has the beneficial effects that:
compared with the traditional microneedle processing technology and microneedles, the microneedle processing technology and microneedles provided by the invention are mainly improved in the following aspects:
(1) a monitor well process is proposed, i.e. the monitor well is formed by step 1 and step 2. The monitoring hole is a fabrication hole and is applied to obtaining accurate long blind holes. Because the depth of the micro-processing etching hole is generally controlled according to the etching speed and the etching time, but the etching speed changes along with the etching environment and the etching width, the etching depth of the hole controlled according to the etching time has larger error, and particularly when a long blind hole is etched, the error is large. The etching of the blind hole is changed into the control of the through hole through the process method for monitoring the hole provided by the invention, as long as the depth of the monitoring hole is etched into the difference value between the thickness of the silicon wafer and the thickness of the long blind hole at the top of the silicon wafer, and then the long blind hole is etched at the bottom of the silicon wafer, when the monitoring hole is etched completely from the bottom direction of the silicon wafer, the length of the long blind hole at the moment is indicated to meet the required length, the continuous etching can be stopped, and the length error of the long blind hole can be avoided.
(2) And (5) providing a composite layer mask process, namely forming a composite layer mask on the top of the silicon wafer through the step 5. The micro-processing technology of the micro-electro-mechanical system based on the micro-electronic processing technology is a two-dimensional processing technology, and a complex three-dimensional structure is difficult to obtain, but the composite layer mask process method provided by the invention is characterized in that the uppermost layer mask and the lowest layer mask are set into different shapes, and a structure is obtained after etching through the upper layer mask; then removing the upper mask, and etching through the lower mask to obtain a composite structure, so that the invention can obtain a more complex three-dimensional structure through a composite layer mask process.
(3) The micro-processing technology of the micro-needle array provided by the invention has the advantages of simple and reliable technology and batch production; and the processing cost is low, the performance consistency is good, and the yield is high.
(4) The micro-processing technology provided by the invention can be used for processing a sharp needle point, and is easy to pierce the skin; the liquid medicine outlet of the processed microneedle is a side outlet, rather than the top of the needle tip, so that the problem that skin tissues block the liquid medicine outlet is avoided; meanwhile, the leakage of the liquid medicine can be prevented.
Drawings
FIG. 1 is a schematic diagram of a first mask obtained by photolithography on top of a silicon wafer according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a monitor hole formed in the top of a silicon wafer by etching according to an embodiment of the present invention;
FIG. 3 is a schematic diagram of a second mask obtained by photolithography on the bottom of a silicon wafer according to an embodiment of the present invention;
fig. 4 is a schematic view of a microneedle hollow cavity obtained by isotropic etching at the bottom of a silicon wafer according to an embodiment of the present invention;
FIG. 5 is a schematic diagram of generating a composite layer mask on top of a silicon wafer according to an embodiment of the present invention;
FIG. 6 is a schematic diagram of a silicon wafer having a microneedle body formed on the top thereof by anisotropic etching and thermally oxidized according to an embodiment of the present invention;
FIG. 7 is a schematic diagram of preliminary forming a microneedle tip and a prism tip by isotropic etching on the top of a silicon wafer according to an embodiment of the present invention;
FIG. 8 is a schematic diagram of forming a liquid side outlet on the top of a silicon wafer by anisotropic etching according to an embodiment of the present invention;
FIG. 9 is a schematic diagram of isotropic etching of sharp microneedle tips and sharp star-shaped prism tips on top of a silicon wafer according to an embodiment of the present invention;
FIG. 10 is a schematic view of a substrate with a lower mask and a protective film removed according to an embodiment of the present invention;
fig. 11 is a schematic perspective view of a microneedle according to an embodiment of the present invention;
FIG. 12 is a schematic diagram of a top mask and a bottom mask provided in accordance with an embodiment of the present invention;
reference numerals: 1 is a silicon wafer; 2 is a microneedle hollow cavity; 3 is an upper mask; 4 is a lower mask; 5 is a microneedle body; 6 is a liquid medicine side outlet; and 7 is a monitoring hole.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly described below with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. 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.
Referring to fig. 1 to 12, an embodiment of the present invention provides a micro-processing process for manufacturing a microneedle array, including the following steps:
step 1: obtaining a first mask on the top of the silicon wafer 1 by photolithography, as shown in fig. 1;
step 2: taking the first mask as a mask, and obtaining a plurality of monitoring holes 7 on the top of the silicon wafer 1 through etching, wherein the plurality of monitoring holes 7 are uniformly distributed on the top of the silicon wafer 1 as shown in fig. 2;
and step 3: obtaining a second mask at the bottom of the silicon wafer 1 through photoetching; as shown in fig. 3;
and 4, step 4: a second mask is used as a mask, and a plurality of microneedle hollow cavities 2 are obtained at the bottom of the silicon wafer 1 through isotropic etching; wherein, at least one microneedle hollow cavity 2 and the monitoring hole 7 are overlapped at the longitudinal position, so that when the monitoring hole 7 is etched into a through hole from the bottom of the silicon wafer 1, the isotropic etching process is stopped; as shown in fig. 4, a plurality of microneedle hollow cavities 2 are uniformly distributed at the bottom of a silicon wafer 1; every two microneedle hollow cavities 2 and one monitoring hole 7 form a microneedle group, one microneedle hollow cavity in each microneedle group is positioned right below the monitoring hole in the group, and the other microneedle hollow cavity and the monitoring hole are not mutually overlapped in the longitudinal position;
and 5: generating a composite layer mask on the top of the silicon wafer 1, wherein the composite layer mask comprises at least two layers of masks from top to bottom; between any two adjacent layers of masks, the mask positioned on the upper layer completely covers the mask positioned on the lower layer, and the shapes of the mask on the uppermost layer and the mask on the lowest layer are different; the mask on the uppermost layer is circular and is used for processing the microneedle body; the bottom mask is star-shaped, and is a mask for processing the tips and the tips of the microneedles, as shown in fig. 12. As shown in fig. 5, the composite layer mask includes two masks: an upper mask 3 and a lower mask 4; the composite layer mask is adjacent to the monitoring hole 7 and located above the microneedle hollow cavity 2, and the transverse length of the bottommost layer mask (for example, the lower layer mask 4) is not less than the inner diameter of the microneedle hollow cavity 2.
In this step, the shapes of the uppermost mask and the lowermost mask are circular and star-shaped, respectively, which are preferred embodiments of the present invention, and it is to be understood that the shapes may be other shapes that can realize the microneedle structure of the present invention.
Step 6: forming a microneedle body 5 on the top of the silicon wafer 1 by anisotropic etching by taking the uppermost mask as a mask, and generating a protective film on the surface of the microneedle body 5 through thermal oxidation; as shown in fig. 6, the microneedle body 5 is formed by masking the upper mask 3;
and 7: removing the rest upper-layer masks except the bottommost mask, taking the bottommost mask as a mask, and preliminarily forming a microneedle tip and a prism tip on the top of the silicon wafer 1 through isotropic etching; as shown in fig. 7, the upper mask 3 is removed and the lower mask 4 is used as a mask;
and 8: continuously taking the mask at the bottommost layer as a mask, and forming a liquid medicine side outlet at the top of the silicon wafer 1 through anisotropic etching; as shown in fig. 8, the lower mask 4 is continuously used as a mask to form a liquid medicine outlet 6;
and step 9: continuously taking the bottom layer mask as a mask, and finally forming the micro-needle tips and the star-shaped prism tips on the top of the silicon wafer 1 through isotropic etching again; as shown in fig. 9, the lower mask 4 is continued to be masked;
step 10: and removing the mask at the bottommost layer and the protective film on the surface of the microneedle body 5 to obtain the microneedle array. As shown in fig. 10 and 11, the microneedle based on the above micro-fabrication process includes: the micro-needle comprises a micro-needle body 5, a micro-needle hollow cavity 2, a micro-needle point, a pyramid tip and a liquid medicine outlet, wherein the liquid medicine outlet is a liquid medicine side outlet 6.
Compared with the traditional microneedle processing technology, the microneedle processing technology provided by the invention is mainly improved in the following aspects:
(1) a monitor well process is proposed, i.e. the monitor well is formed by step 1 and step 2. The monitoring hole is a fabrication hole and is applied to obtaining accurate long blind holes. Because the depth of the micro-processing etching hole is generally controlled according to the etching speed and the etching time, but the etching speed changes along with the etching environment and the etching width, the etching depth of the hole controlled according to the etching time has larger error, and particularly when a long blind hole is etched, the error is large. The etching of the blind hole is changed into the control of the through hole through the process method for monitoring the hole provided by the invention, as long as the depth of the monitoring hole is etched into the difference value between the thickness of the silicon wafer and the thickness of the long blind hole at the top of the silicon wafer, and then the long blind hole is etched at the bottom of the silicon wafer, when the monitoring hole is etched completely from the bottom direction of the silicon wafer, the length of the long blind hole at the moment is indicated to meet the required length, the continuous etching can be stopped, and the length error of the long blind hole can be avoided.
(2) And (5) providing a composite layer mask process, namely forming a composite layer mask on the top of the silicon wafer through the step 5. The micro-processing technology of the micro-electro-mechanical system based on the micro-electronic processing technology is a two-dimensional processing technology, and a complex three-dimensional structure is difficult to obtain, but the composite layer mask process method provided by the invention is characterized in that the uppermost layer mask and the lowest layer mask are set into different shapes, and a structure is obtained after etching through the upper layer mask; then removing the upper mask, and etching through the lower mask to obtain a composite structure, so that the invention can obtain a more complex three-dimensional structure through a composite layer mask process.
Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (6)
1. A micro-fabrication process for fabricating a microneedle array, comprising:
step 1: obtaining a first mask on the top of the silicon wafer through photoetching;
step 2: taking the first mask as a mask, and etching the top of the silicon wafer to obtain a plurality of monitoring holes;
and step 3: obtaining a second mask at the bottom of the silicon wafer through photoetching;
and 4, step 4: a second mask is used as a mask, and a plurality of microneedle hollow cavities are obtained at the bottom of the silicon wafer through isotropic etching; wherein at least one microneedle hollow cavity and a monitoring hole are overlapped at a longitudinal position, so that when the monitoring hole is etched into a through hole from the bottom of a silicon wafer, an isotropic etching process is stopped;
and 5: generating a composite layer mask on the top of the silicon wafer, wherein the composite layer mask comprises at least two layers of masks from top to bottom; between any two adjacent layers of masks, the mask positioned on the upper layer completely covers the mask positioned on the lower layer, and the shapes of the mask on the uppermost layer and the mask on the lowest layer are different;
step 6: forming a microneedle body on the top of the silicon wafer by anisotropic etching by taking the uppermost mask as a mask, and thermally oxidizing the surface of the microneedle body to generate a protective film;
and 7: removing the rest upper-layer masks except the bottommost mask, taking the bottommost mask as a mask, and preliminarily forming a microneedle tip and a prism tip on the top of the silicon wafer through isotropic etching;
and 8: continuously taking the mask at the bottommost layer as a mask, and forming a liquid medicine side outlet at the top of the silicon wafer through anisotropic etching;
and step 9: continuously taking the bottom layer mask as a mask, and finally forming the microneedle tips and the star-shaped prism tips on the top of the silicon wafer through isotropic etching again;
step 10: and removing the bottommost layer mask and the protective film on the surface of the microneedle body to obtain the microneedle array.
2. The micromachining process according to claim 1, wherein the plurality of monitor holes are uniformly distributed on the top of the silicon wafer, and the plurality of microneedle cavities are uniformly distributed on the bottom of the silicon wafer.
3. The micromachining process according to claim 2, wherein every two microneedle hollow cavities and one monitoring hole form a microneedle set, one microneedle hollow cavity in each microneedle set is positioned right below the monitoring hole in the set, and the other microneedle hollow cavity and the monitoring hole are not overlapped with each other in the longitudinal position.
4. The microfabrication process of claim 3, wherein the composite layer mask is adjacent to the monitoring hole and above the microneedle hollow cavity, and a lateral length of a lowermost layer mask is not less than an inner diameter of the microneedle hollow cavity.
5. The micromachining process of claim 1, wherein the uppermost mask is circular and the lowermost mask is star-shaped.
6. The micro-needle of micro-processing technology for manufacturing micro-needle array according to claim 1, comprising a micro-needle body, a micro-needle hollow cavity, a micro-needle point, a prism point and a liquid medicine outlet, wherein the liquid medicine outlet is a side outlet.
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| CN114849051A (en) * | 2022-04-02 | 2022-08-05 | 相邦(苏州)生物材料科技有限公司 | Preparation method of silicon-based microneedle |
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