阅读说明：本技术 一种单电极植入式血糖传感器 (Single-electrode implanted blood glucose sensor ) 是由 梁波 叶学松 任航旭 于 2019-11-20 设计创作，主要内容包括：本发明公开了一种单电极植入式血糖传感器,它包含一基底,基底下平面固定有针形正电极与扁平形的负电极。扁平形负电极下端贴近皮肤处修饰有导电凝胶,针形正电极与扁平形负电极上端皆连接有导电片。在导电片上端固定有一块印刷电路板,正负电极的电信号通过导电片与印刷电路板的触点连接。本发明的针形正电极刺入并停留在人体皮肤的浅表层,负电极则固定于体表,以此来持续探测体液中血糖反应电流并转化成血糖浓度参数输出,实现对血糖的连续测量,并具有创口小,操作简单,工艺简化的特点。(The invention discloses a single-electrode implanted blood sugar sensor, which comprises a substrate, wherein a needle-shaped positive electrode and a flat negative electrode are fixed on the lower plane of the substrate. The lower end of the flat negative electrode is decorated with conductive gel close to the skin, and the needle-shaped positive electrode and the upper end of the flat negative electrode are both connected with conductive strips. A printed circuit board is fixed on the upper end of the conducting strip, and the electric signals of the positive and negative electrodes are connected with the contact of the printed circuit board through the conducting strip. The needle-shaped positive electrode of the invention pierces into and stays on the superficial layer of the skin of the human body, and the negative electrode is fixed on the body surface, so as to continuously detect the blood sugar reaction current in the body fluid and convert the blood sugar reaction current into the blood sugar concentration parameter for output, thereby realizing the continuous measurement of the blood sugar.)

1. A single-electrode implanted blood glucose sensor is characterized by comprising a base (1) and a printed circuit board (5), wherein a needle-shaped positive electrode (2) and a flat negative electrode (3) are fixed on the bottom surface of the base (1), and the distance between the tip of the needle-shaped positive electrode (2) and the bottom surface of the base (1) is greater than the distance between the bottom surface of the flat negative electrode (3) and the bottom surface of the base (1); the fixed ends of the needle-shaped positive electrode (2) and the flat negative electrode (3) are respectively connected with corresponding signal contacts on a printed circuit board (5) through different conducting strips (4) to form a double-electrode system for detecting blood sugar.

2. The single-electrode implantable blood glucose sensor according to claim 1, wherein the needle-shaped positive electrode (2) is a multi-layer composite structure, the needle core (2.1) located at the center is made of metal, and the catalytic metal layer (2.2), the biosensing layer (2.3) and the biocompatible polymer permeation membrane layer (2.4) are sequentially wrapped outside the needle core (2.1).

3. The single-electrode implantable blood glucose sensor of claim 2, wherein the catalytic metal layer (2.2) is a platinum layer.

4. The single-electrode implantable blood glucose sensor of claim 2, wherein the biosensing layer (2.3) is a glucose oxidase layer.

5. The single-electrode implantable blood glucose sensor of claim 2, wherein the biocompatible polymer permeable membrane layer (2.4) is a polyurethane layer.

6. The single-electrode implantable blood glucose sensor as claimed in claim 1, wherein the flat negative electrode (3) has an internal structure made of metal and a silver/silver chloride layer compounded on the surface thereof.

7. The single-electrode implantable blood glucose sensor of claim 1, wherein the flat negative electrode (3) is covered with a conductive layer on the bottom surface for fitting the skin of a human body; the conductive layer is preferably an electrically conductive gel.

8. The single-electrode implantable blood glucose sensor of claim 1, wherein a counter electrode is further fixed on the bottom surface of the base (1), and the counter electrode is also connected with a corresponding signal contact on the printed circuit board (5) through the conducting strip (4) to form a three-electrode system.

9. The single-electrode implantable blood glucose sensor of claim 1, wherein the base (1) is provided with an electrically insulating cover (6), and the printed circuit board (5) is disposed and enclosed within the lumen defined therebetween.

10. The single-electrode implantable blood glucose sensor of claim 1, wherein the printed circuit board (5) comprises a potentiostatic circuit, a bluetooth antenna, metal contacts, a microprocessor, and a lithium battery.

Technical Field

The invention relates to a device in the technical field of medical monitoring instruments, in particular to a single-electrode implanted blood glucose sensor.

Background

Monitoring of blood glucose is very important for diabetics, and blood glucose values help to assess conditions of glucose metabolism disorders in diabetics. The diabetes management can be effectively carried out by real-time continuous dynamic monitoring of the blood sugar, and the blood sugar is maintained at a normal value by timely injecting insulin or supplementing glucose.

At present, there is a method for monitoring in vitro after blood collection, but the change of glucose concentration in the body of a diabetic patient is influenced by various factors, and the instantaneous concentration of the glucose concentration is unpredictable under the influence of various factors such as environmental temperature, mood change, physical activity and the like. When the method is used for controlling the blood sugar level, blood must be taken for many times every day, which causes heavy burden on the mind and body of a patient.

The existing portable dynamic blood glucose sensor comprises 2 to 3 electrodes, the front ends of all the electrodes need to be invaded into the skin of a human body in the using process and stay on the superficial layer of the skin of the human body, so that at least 2 to 3 wounds are generated, the complexity of operation is increased, and a plurality of wounds can generate certain psychological pressure on a patient.

At present, two electrodes can be integrated at an intrusion end in order to reduce wounds, but the method needs more complex process means.

Disclosure of Invention

Aiming at the defects in the prior art, the invention provides a single-electrode implanted blood glucose sensor. The working electrode of the sensor is punctured into and stays on the superficial layer of human skin, while the reference electrode is attached and fixed on the surface of the human skin, so that the blood sugar is continuously monitored, and only one wound is generated.

The technical scheme adopted by the invention for solving the technical problems is as follows:

a single electrode implanted blood sugar sensor is provided with a base and a printed circuit board, wherein a needle-shaped positive electrode and a flat negative electrode are fixed on the bottom surface of the base, and the distance between the tip of the needle-shaped positive electrode and the bottom surface of the base is larger than the distance between the bottom surface of the flat negative electrode and the bottom surface of the base; the fixed ends of the needle-shaped positive electrode and the flat negative electrode are respectively connected with corresponding signal contacts on a printed circuit board through different conducting strips to form a double-electrode system for detecting blood sugar.

Preferably, the needle-shaped positive electrode is of a multilayer composite structure, the needle core positioned in the center is made of a metal material, and the outside of the needle core is sequentially wrapped with a catalytic metal layer, a biosensing layer and a biocompatible polymer permeation membrane layer.

Further, the catalytic metal layer is a platinum layer.

Further, the biosensing layer is a glucose oxidase layer.

Furthermore, the biocompatible polymer permeable membrane layer is a polyurethane layer.

Preferably, the inner structure of the flat negative electrode is made of metal, and the surface of the inner structure is compounded with a silver/silver chloride layer.

Preferably, a counter electrode is further fixed on the bottom surface of the base, and the counter electrode is also connected with a corresponding signal contact on the printed circuit board through a conducting strip to form a three-electrode system.

Preferably, the bottom surface of the flat negative electrode, which is used for being attached to the skin of a human body, is covered with a conductive layer. If the sensor is provided with a counter electrode, the bottom surface of the counter electrode, which is used for being attached to the skin of a human body, needs to be covered with a conductive layer. Further, the conductive layer is a conductive gel.

Preferably, an electrically insulating top cover is mounted on the base, and the printed circuit board is disposed and enclosed in the cavity defined by the two.

Preferably, the printed circuit board comprises a constant potential circuit, a Bluetooth antenna, a metal contact, a microprocessor and a lithium battery.

Compared with the prior art, the invention has the following beneficial effects: only one needle-shaped positive electrode is implanted under the skin, so that the blood glucose reaction current in the body fluid is continuously detected and converted into blood glucose concentration parameters for continuous output. Only one wound is needed in the whole process, so that the pain feeling during implantation can be greatly reduced, and the user experience is increased.

Drawings

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

FIG. 2 is an exploded view of the present invention;

fig. 3 is a schematic diagram of a needle-shaped positive electrode of the present invention.

The reference numbers in the figures are: the biosensor comprises a base 1, a needle-shaped positive electrode 2, a flat negative electrode 3, a conducting strip 4, a printed circuit board 5, a top cover 6, a needle core 2.1, a catalytic metal layer 2.2, a biosensing layer 2.3 and a biocompatible polymer permeation film layer 2.4.

Detailed Description

The following detailed description of the embodiments of the present invention is provided in conjunction with the accompanying drawings, which are set forth in the appended claims, and are intended to illustrate the embodiments of the present invention.

In a preferred embodiment of the present invention, as shown in figures 1 and 2, a single electrode implantable blood glucose sensor is provided having a base 1 and a printed circuit board 5 disposed therein. The base 1 is a mounting framework of the whole sensor, and a needle-shaped positive electrode 2 and a flat negative electrode 3 are fixed on the bottom surface of the base 1. The needle-shaped positive electrode 2 is vertically installed with the bottom surface of the base 1, the tip end of the needle-shaped positive electrode is arranged downwards, and the flat negative electrode 3 is flatly attached to the bottom of the base 1. When in use, the tip of the needle-shaped positive electrode 2 is implanted into the surface layer of the skin, and the flat negative electrode 3 is tightly adhered to the surface of the skin, so the distance between the tip of the needle-shaped positive electrode 2 and the bottom surface of the base 1 needs to be larger than the distance between the bottom surface of the flat negative electrode 3 and the bottom surface of the base 1, and the tip of the needle-shaped positive electrode 2 is more protruded relative to the bottom surface of the flat negative electrode 3. The fixed end of the needle-shaped positive electrode 2 is connected with a metal contact point for signal input on the printed circuit board 5 through a conducting strip 4, and the fixed end of the flat negative electrode 3 is connected with another metal contact point for signal input on the printed circuit board 5 through another conducting strip 4, thereby forming a double-electrode system for blood sugar detection. The two electrodes generate an electric signal capable of reflecting the blood glucose concentration through an electrochemical reaction, and transmit the electric signal into the printed circuit board 5. An electrically insulating top cover 6 of plastic material is fitted to the base 1, and a printed circuit board 5 is housed and enclosed in the cavity formed by the two.

In the present invention, the needle-shaped positive electrode 2 and the flat negative electrode 3 are used for acquiring the blood glucose concentration electrical signal in the body fluid, and the printed circuit board 5 is used for receiving the blood glucose concentration electrical signal acquired by the electrodes and processing the signals accordingly. The specific form and circuit structure of the printed circuit board 1-2 can be designed for the desired function, or the existing commercial products can be used, which is not the key of the present invention. Generally, a constant potential circuit, a bluetooth antenna, a metal contact, a microprocessor, a peripheral circuit and a lithium battery are required to be arranged on the printed circuit board 5. The electric signals collected by the electrodes need to be transmitted to a microprocessor of the printed circuit board 5 through metal contacts, and then are wirelessly transmitted to a corresponding upper computer through a Bluetooth antenna.

In a two-electrode system, the needle-shaped positive electrode 2 serves as a working electrode, and the form thereof can be realized by any blood glucose electrode in the prior art. In the present embodiment, however, a needle-shaped positive electrode 2 of a multilayer composite structure as shown in fig. 3 is provided. The needle core 2.1 in the center is made of metal, and the material is stainless steel. The needle core 2.1 is sequentially wrapped with a catalytic metal layer 2.2, a biological sensing layer 2.3 and a biocompatible polymer permeation film layer 2.4. In this embodiment, the catalytic metal layer 2.2 is a platinum layer, the biosensing layer 2.3 is a glucose oxidase layer, and the biocompatible polymer permeable membrane layer 2.4 is a polyurethane Pu layer. The three-layer structure is plated or coated on the periphery of the needle core 2.1 in a nesting mode layer by layer, blood sugar in body fluid can permeate through the Pu layer, the voice oxidation-reduction reaction is carried out in the glucose oxidase layer on the surface of the platinum layer, then the oxidation-reduction potential is generated, and electric signals are transmitted outwards through the needle core 2.1.

Likewise, the flat negative electrode 3 serves as a reference electrode, and may be implemented in any prior art silver/silver chloride electrode. However, in the present embodiment, the inner structure is a flat metal block, and the surface of the metal block is compounded with a silver/silver chloride layer, so as to reduce the cost. In addition, the bottom surface of the flat negative electrode 3 for fitting the human skin is covered with a conductive layer, wherein the conductive layer is preferably a sticky conductive gel. The conductive gel has better viscosity, can contact with the skin to transmit signals in the use process, and simultaneously fixes the single-electrode implantable blood glucose sensor.

When the single-electrode implantable blood glucose sensor is used, the tip of the needle-shaped positive electrode 2 of the single-electrode implantable blood glucose sensor penetrates into the superficial layer of human skin, stays in a tissue fluid layer and is in electrochemical reaction with body fluid, and the flat negative electrode 3 is fixed on the surface of the human skin through conductive gel, so that only one wound is generated. The sensor continuously monitors blood sugar, and data is output to the printed circuit board through the conducting strip in a form of reaction current through the contact, so that the dynamic blood sugar of a human body is monitored.

Of course, if necessary, a counter electrode can be fixed on the bottom surface of the base 1, and the counter electrode is also connected with a corresponding signal contact on the printed circuit board 5 through the conducting strip 4, so that a three-electrode system is formed to improve the stability of blood sugar monitoring.

In addition, each electrode in the invention can be detachably mounted or attached to the bottom surface of the base 1, and can be detached and replaced when a monitoring process is completed once, and the base 1 and the printed circuit board 5 are reused, so that the use cost is reduced. Therefore, the invention has the characteristics of small wound, simple operation and simplified process.

The above-described embodiments are merely preferred embodiments of the present invention, which should not be construed as limiting the invention. Various changes and modifications may be made by one of ordinary skill in the pertinent art without departing from the spirit and scope of the present invention. Therefore, the technical scheme obtained by adopting the mode of equivalent replacement or equivalent transformation is within the protection scope of the invention.