Microneedle array medicine patch and glucose detection device and method

Abstract

The invention discloses a microneedle array medicine patch and a glucose detection device and method, and relates to the technical field of glucose detection. The micro-needle array medicine patch comprises a piezoelectric ultrasonic transducer and a micro-needle array, a through hole is formed in the piezoelectric ultrasonic transducer in the axial direction, the micro-needle array is arranged on the piezoelectric ultrasonic transducer, a plurality of nanotube micro-needles are arranged in the area, corresponding to the through hole, of the surface of the micro-needle array, and a micro-channel communicated with the through hole is formed in each nanotube micro-needle; the glucose detection device comprises an annular first shell, a second shell matched with the first shell to form a containing groove, and a circuit board provided with an ultrasonic control circuit and a glucose sensor; according to the technical scheme provided by the invention, painless / low-pain, rapid and efficient transdermal glucose detection is realized.

Description

Technical Field

[0001] The present invention relates to the technical field of glucose detection, and in particular to a microneedle array patch, a glucose detection device and a method. Background Art

[0002] Globally, the prevalence of diabetes is increasing year by year, putting tremendous pressure on the public health system. Diabetes is a chronic metabolic disease characterized by long-term elevated blood sugar (glucose) levels in the body, mainly due to insufficient insulin secretion, impaired insulin action, or both, which results in the body's inability to use glucose normally. If diabetes is not well controlled, it can lead to a variety of acute and chronic complications. Therefore, diabetic patients need to monitor their blood sugar regularly, understand their own blood sugar fluctuations, and adjust their treatment plans in a timely manner.

[0003] Existing glucose testing technologies usually include fingertip blood testing, continuous glucose monitoring system testing, and laboratory glucose testing. Among them, fingertip blood testing requires a needle to puncture the skin each time, which will cause pain to the patient and increase the risk of infection; the continuous glucose monitoring system is expensive, and subcutaneous implantation may cause skin discomfort or even infection; laboratory glucose testing requires blood testing at a medical institution each time, which brings inconvenience to patients. Summary of the invention

[0004] The embodiments of the present invention provide a microneedle array patch, a glucose detection device and a method, aiming to achieve painless / low-pain, rapid and efficient transcutaneous glucose detection.

[0005] The microneedle array patch provided by the present invention comprises:

[0006] A piezoelectric ultrasonic transducer is provided with a through hole along the axial direction;

[0007] A microneedle array is arranged on the piezoelectric ultrasonic transducer; a plurality of nanotube microneedles are arranged on the surface of the microneedle array in the area corresponding to the through hole, and the nanotube microneedles form a microchannel connected with the through hole.

[0008] Optionally, the nanotube microneedle has an inner diameter of 50-200 nm, an outer diameter of 5-20 μm, a height of 100-300 μm, and a spacing of 200-500 μm.

[0009] Optionally, the nanotube microneedle is made of titanium or titanium alloy.

[0010] Optionally, the piezoelectric ultrasonic transducer includes a backing and a piezoelectric layer disposed on the backing, and the piezoelectric layer is bonded to the microneedle array.

[0011] Optionally, the piezoelectric layer includes multiple layers of piezoelectric ceramics, and an intermediate layer is provided between any two layers of piezoelectric ceramics.

[0012] Optionally, the backing and the intermediate layer are made of at least one of stainless steel, titanium and titanium alloy.

[0013] Optionally, the operating frequency of the piezoelectric ultrasonic transducer is 20kHz-100kHz.

[0014] The glucose detection device provided by the present invention comprises:

[0015] an annular first shell;

[0016] A second shell, which cooperates with the first shell to form a receiving groove; the second shell constitutes the bottom of the receiving groove, and the top of the receiving groove is used to install the microneedle array patch according to any one of claims 1 to 6;

[0017] The circuit board is arranged in the containing groove, and comprises an ultrasonic control circuit and a glucose sensor arranged corresponding to the through hole of the microneedle array patch. The ultrasonic control circuit is electrically connected to the piezoelectric ultrasonic transducer of the microneedle array patch.

[0018] Optionally, the glucose detection device further comprises a display module for displaying detection data of the glucose sensor.

[0019] Optionally, the glucose detection device further includes a wireless communication module for sending detection data of the glucose sensor to a communication terminal.

[0020] The glucose detection method provided by the present invention uses the glucose detection device described above, and the detection steps include:

[0021] Installing the microneedle array patch described above in the installation slot of the glucose detection device;

[0022] placing the installed microneedle array patch against skin tissue;

[0023] The glucose detection device is started, and the microneedle array patch is caused to generate axial vibration through the ultrasonic control circuit.

[0024] The present invention has the following beneficial effects:

[0025] The circuit board of the glucose detection device generates a high-frequency signal and applies it to the piezoelectric ultrasonic transducer, causing the piezoelectric ultrasonic transducer to generate high-frequency mechanical vibrations. During the puncture process of the microneedle patch, the high-frequency mechanical vibrations of the piezoelectric ultrasonic transducer can temporarily change the permeability of the cell membrane, allowing deeper interstitial fluid to be extracted, ensuring the accuracy of the detection while reducing the puncture force of the microneedle array patch. Thereafter, the nanotube microneedles of the microneedle array patch puncture the skin tissue and come into contact with the interstitial fluid, and the interstitial fluid containing glucose is instantly extracted under the action of the cavitation effect, and the extracted glucose is then detected and quantified in real time using a glucose sensor, thereby achieving painless, rapid and efficient transcutaneous glucose detection. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0027] Figure 1 Schematic diagrams of the structures of some embodiments of the microneedle array patch of the present invention;

[0028] Figure 2 It is a schematic diagram of the structure of some embodiments of the glucose detection device of the present invention;

[0029] Figure 3 for Figure 2 Schematic diagram of the explosion structure of the glucose detection device shown.

[0030] Description of Figure Numbers:

[0031] 1. Microneedle array patch; 11. Microneedle array; 111. Nanotube microneedle; 12. Piezoelectric ultrasonic transducer; 121. Backing; 122. Piezoelectric ceramic; 123. Intermediate layer; 2. First shell; 3. Second shell; 4. Circuit board; 5. Button. DETAILED DESCRIPTION

[0032] In order to make the purpose, features and advantages of the present invention more obvious and easy to understand, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the embodiments described below are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] A first aspect of the present invention provides a microneedle array patch.

[0034] See also Figure 1 and Figure 3 The microneedle array patch 1 includes: a piezoelectric ultrasonic transducer 12, which is provided with a through hole along the axial direction; a microneedle array 11, which is arranged on the piezoelectric ultrasonic transducer 12; a plurality of nanotube microneedles 111 are provided on the surface of the microneedle array 11 corresponding to the through hole, and the nanotube microneedles 111 form a microchannel (not shown in the figure) connected to the through hole.

[0035] During the puncture process of the microneedle array patch on the skin tissue, the piezoelectric ultrasonic transducer generates high-frequency mechanical vibration under the condition of an external control circuit, which can temporarily change the permeability of the cell membrane and extract the interstitial fluid at a deeper level, ensuring the accuracy of the detection while reducing the puncture force of the microneedle array patch; then the nanotube microneedles of the microneedle array patch puncture the skin tissue and come into contact with the interstitial fluid, and the interstitial fluid containing glucose is instantly extracted under the action of the cavitation effect, and the extracted interstitial fluid enters the through-hole of the piezoelectric ultrasonic transducer through the microchannel.

[0036] In some embodiments, the inner diameter of the nanotube microneedle can be selected to be 50-200nm, the outer diameter can be selected to be 5-20μm, the height can be selected to be 100-300μm, and the spacing can be selected to be 200-500μm; the depth of microneedle penetration into the skin only reaches below the stratum corneum, does not stimulate the nerve endings in the dermis, and the wound is extremely small, reducing the risk of blood exposure and infection.

[0037] In some embodiments, the nanotube microneedle is made of titanium or titanium alloy, which has the advantages of good biocompatibility and good fluidity of skin tissue interstitial fluid.

[0038] In other embodiments, the material of the nanotube microneedle may also be other metals or alloys such as nickel, silicon-based, polymers, etc.

[0039] In the embodiments of the present invention, the microneedle array includes but is not limited to an eccentric microneedle array, a hollow microneedle array and a porous microneedle array.

[0040] In some specific embodiments, laser cutting technology is used to prepare a template with a micron pore structure, such as a silicon template, a polymer template or a film, a titanium sheet is placed on the template for anodization, and a titanium nanotube structure is formed on the surface of the titanium substrate through an electrolysis process (by using a titanium-based material as an anode in a specific electrolyte and applying a voltage to cause an oxidation reaction on the titanium surface to form a nanotube structure), and then a chemical or physical method is used to remove the template, leaving a titanium nanotube array, thereby obtaining a microneedle array composed of titanium nanotube microneedles.

[0041] The piezoelectric ultrasonic transducer may be a Langevin transducer or a transducer solely composed of piezoelectric ceramics.

[0042] See also Figure 1 In some embodiments, the piezoelectric ultrasonic transducer 12 includes a backing 121 and a piezoelectric layer disposed on the backing 121, and the piezoelectric layer is bonded to the microneedle array 11; the piezoelectric layer includes a multilayer piezoelectric ceramic 122, and any two layers of piezoelectric ceramics 122 are separated by an intermediate layer 123. The design of the multilayer piezoelectric ceramic increases the displacement output and can achieve a fast response.

[0043] It can be understood that the backing 121, the piezoelectric ceramic 122 and the intermediate layer 123 are concentric ring structures, and can be glued together by metal glue to form a piezoelectric ultrasonic transducer 12 with an axial through hole.

[0044] The material of the backing 121 includes but is not limited to stainless steel, titanium, and titanium alloy, and has good biocompatibility and corrosion resistance.

[0045] The material of the middle layer 123 includes but is not limited to stainless steel, titanium, and titanium alloy.

[0046] The piezoelectric ceramic 122 may be lead-based piezoelectric ceramic (such as PZT piezoelectric ceramic) or lead-free piezoelectric ceramic (such as barium titanate piezoelectric ceramic).

[0047] In some embodiments, the operating frequency of the piezoelectric ultrasonic transducer may be selected to be 20 kHz-100 kHz.

[0048] A second aspect of the present invention provides a glucose detection device.

[0049] See also Figure 2 and Figure 3 The glucose detection device includes: a first annular shell 2; a second shell 3, which cooperates with the first shell 2 to form a receiving groove; the second shell 3 constitutes the bottom of the receiving groove, and the top of the receiving groove is used for the microneedle array patch 1 provided in the aforementioned embodiment; a circuit board 4 is arranged in the receiving groove, including an ultrasonic control circuit and a glucose sensor arranged corresponding to the through hole of the microneedle array patch 1, and the ultrasonic control circuit is electrically connected to the piezoelectric ultrasonic transducer of the microneedle array patch 1.

[0050] In some embodiments, a button 5 is further provided on the circuit board 4 for controlling the start and stop of the piezoelectric ultrasonic transducer; a through hole for axial movement of the button 5 is correspondingly provided on the first shell 3 .

[0051] In some embodiments, the frequency, intensity and duration of the ultrasonic control circuit can be adjusted by a microcontroller, and the shell is provided with corresponding human-computer interaction modules such as buttons, knobs, touch screen, etc., which are connected to the microcontroller through serial port communication, thereby realizing convenient control of the piezoelectric ultrasonic transducer.

[0052] In some embodiments, the glucose detection device further includes a display module for displaying detection data of the glucose sensor.

[0053] In some embodiments, the glucose detection device further includes a wireless communication module for sending detection data of the glucose sensor to a communication terminal.

[0054] The third aspect of the present invention provides a glucose detection method, which uses the microneedle array patch and glucose detection device provided in the above embodiments to achieve transdermal detection, and the detection steps include:

[0055] Step 1, installing the microneedle array patch on the receiving groove of the glucose detection device;

[0056] Step 2, placing the installed microneedle array patch against the skin tissue;

[0057] Step 3, start the glucose detection device and make the microneedle array patch produce axial vibration through the ultrasonic control circuit.

[0058] By adjusting the frequency, intensity and duration of the ultrasonic control circuit, the mechanical vibration of the microneedle array patch can be changed and the intensity of the cavitation effect can be controlled, thereby optimizing the extraction effect while reducing damage to healthy tissue around the sampling area.

[0059] The specific process of implementing transdermal testing using the microneedle array patch and glucose detection device provided in the above embodiments is as follows:

[0060] The high-frequency signal generated by the circuit board is applied to the piezoelectric ultrasonic transducer, causing the piezoelectric ultrasonic transducer to generate high-frequency mechanical vibrations. During the puncture process of the microneedle array patch, the high-frequency mechanical vibrations of the piezoelectric ultrasonic transducer change the skin structure and the permeability of the cell membrane, so that the interstitial fluid at a deeper level is extracted, ensuring the accuracy of the detection and reducing the puncture force of the microneedle array patch. After the microneedle array patch punctures the skin tissue, it contacts the interstitial fluid, and the interstitial fluid is extracted instantaneously under the action of the cavitation effect. After the interstitial fluid passes through the microchannel of the nanotube microneedle and the through hole of the piezoelectric ultrasonic transducer, it contacts the working electrode of the glucose sensor arranged on the circuit board, and the sensor performs real-time detection and quantification of the glucose in the extracted interstitial fluid. After use, the glucose detection device can be reused and matched with a new microneedle array patch, and the used microneedle array patch can be treated as medical waste.

[0061] The overall technical solution provided by the present invention realizes painless, rapid and efficient detection of transcutaneous glucose, and has important clinical significance and application value in blood glucose monitoring.

[0062] The embodiments described above are only used to illustrate the technical solutions of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, a person skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A microneedle array patch, characterized in that: include: A piezoelectric ultrasonic transducer is provided with a through hole along the axial direction; A microneedle array is arranged on the piezoelectric ultrasonic transducer; a plurality of nanotube microneedles are arranged on the surface of the microneedle array in the area corresponding to the through hole, and the nanotube microneedles form a microchannel connected with the through hole.

2. The microneedle array patch according to claim 1, characterized in that: The nanotube microneedle has an inner diameter of 50-200 nm, an outer diameter of 5-20 μm, a height of 100-300 μm, and a spacing of 200-500 μm.

3. The microneedle array patch according to claim 1, characterized in that: The material of the nanotube microneedle is titanium or titanium alloy.

4. The microneedle array patch according to claim 1, characterized in that: The piezoelectric ultrasonic transducer comprises a backing and a piezoelectric layer arranged on the backing, and the piezoelectric layer is bonded to the microneedle array.

5. The microneedle array patch according to claim 4, characterized in that: The piezoelectric layer includes multiple layers of piezoelectric ceramics, and an intermediate layer is provided between any two layers of piezoelectric ceramics.

6. The microneedle array patch according to claim 5, characterized in that: The backing and the intermediate layer are made of at least one of stainless steel, titanium and titanium alloy.

7. A glucose detection device, characterized in that: include: an annular first shell; A second shell, cooperating with the first shell to form a receiving groove; The second shell constitutes the bottom of the receiving groove, and the top of the receiving groove is used to install the microneedle array patch according to any one of claims 1 to 6; The circuit board is arranged in the containing groove, and comprises an ultrasonic control circuit and a glucose sensor arranged corresponding to the through hole of the microneedle array patch. The ultrasonic control circuit is electrically connected to the piezoelectric ultrasonic transducer of the microneedle array patch.

8. The glucose detection device according to claim 7, characterized in that: The glucose detection device further includes a display module for displaying detection data of the glucose sensor.

9. The glucose detection device according to claim 7, characterized in that: The glucose detection device further includes a wireless communication module for sending detection data of the glucose sensor to a communication terminal.

10. A method for detecting glucose, characterized in that: Using the glucose detection device according to any one of claims 7 to 9, the detection step comprises: Installing the microneedle array patch according to any one of claims 1 to 6 in the installation groove of the glucose detection device; placing the installed microneedle array patch against skin tissue; The glucose detection device is started, and the microneedle array patch is caused to generate axial vibration through the ultrasonic control circuit.

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