CN110051365A - A kind of implanted electrode for continuing to monitor for a long time - Google Patents

Abstract

The invention discloses an implantable electrode for long-term continuous monitoring, comprising a base electrode, a sensing cavity, an insulating layer, a connection contact and a piercing part. The sensing cavity is located in the middle of the electrode, and both ends are covered by an insulating layer, forming a structure with high ends and a low middle. The implanted electrode for long-term continuous monitoring provided by the present invention can be inserted into the dermis layer of the human body with bare hands to continuously monitor the changes of blood sugar in the body fluid. It has the advantages of simple and compact structure, long monitoring time, convenient operation, alleviation of implantation trauma, and avoidance of the sensor film layer falling off.

Description

An implantable electrode for long-term continuous monitoring

【Technical field】

The patent of the present invention relates to the technical field of medical monitoring equipment, in particular to a microneedle electrode for subcutaneous continuous blood glucose monitoring.

【Background technique】

According to the International Diabetes Federation (IDF), the current global prevalence of diabetes among adults aged 20 to 79 is 8.8%, and it is expected to rise to 10.4% by 2040. Diabetes is spreading so fast that about 5 million people die each year from diabetes and its related complications, accounting for 14.5% of all-cause deaths, a significant increase from 8.39% in 2013. Among them, my country ranks first in the world with 109.6 million patients, and it is expected to increase to 151 million by 2040, and the number of deaths due to diabetes exceeds 1 million every year.

However, the survey found that the treatment rate of diabetic patients in my country is only 25.8%. Since the harm of diabetes mainly lies in various complications caused by it, patients who fail to receive treatment are more likely to suffer from complications. And according to the latest research by Chinese and British scientists, compared with people without diabetes, the average life expectancy of Chinese adults with diabetes will be shortened by 9 years.

At present, the treatment of diabetes is to maintain the blood sugar level of patients within the normal range through lifestyle intervention, stem cell therapy and personalized drug therapy to achieve different degrees of remission, and there is no complete cure. The more traditional finger blood measurement method has obvious effect on blood sugar control, but because it cannot warn and detect high and low blood sugar, especially for nocturnal hypoglycemia and asymptomatic hypoglycemia that damage the body, the therapeutic effect has certain limitations. Continuous blood glucose monitoring technology has the advantage of reflecting and predicting the characteristics of blood glucose fluctuations, which is of great significance for relieving diabetes. However, for most patients, CGM products are mostly imported, and a sensor can only monitor for about 7 days, which cannot achieve long-term monitoring. Repeated replacement of the sensor will bring the risk of infection and a heavy economic burden.

To this end, the applicant has designed an implantable electrode for long-term continuous monitoring. The electrode is designed with a cavity-type spiral sensing part, aiming to design a sensing electrode that can be easily used by patients and monitored for a long time, so as to improve the patient's safety. Compliance, to maintain long-term stable blood sugar concentration, away from hyperglycemia and its complications.

[Content of the invention]

Aiming at the defects of the above-mentioned prior art, the patent of the present invention designs an implantable electrode for long-term continuous monitoring, which is simple and compact in structure, can be monitored for a long time, easy to operate with bare hands, and can reduce implantation trauma. Disorder patients realize self-monitoring and stable control of blood glucose concentration.

An implantable electrode for long-term continuous monitoring includes a base electrode, a sensing cavity, an insulating layer, a connecting contact, and a piercing part; the base electrode material is rigid metal, the shape is needle-shaped, and the diameter is 0.1-0.5 mm, and the length is less than 10cm; the insulating layer material is an insulating polymer material, which is coated in the area outside the sensing cavity; the sensing cavity is located in the middle of the electrode, and the two ends are covered by an insulating layer, forming two ends high, the middle The low structure includes a spiral functional layer, a signal enhancement layer, a carrier layer, a signal layer, and an isolation layer.

The material of the helical functional layer is a noble metal modified on the base electrode; the material of the signal enhancement layer is a noble metal nanoparticle, which is modified on the helical functional layer and the base electrode; the material of the carrier layer is a functional polymer material; the material of the signal layer is a reaction catalyst. Any one or more combinations; the isolation layer material is any one or more combinations of biocompatible polymer materials; the surface of the piercing portion is coated with an insulating layer and an isolation layer.

The insulating layer is coated on other parts except the sensing cavity, and the thickness is larger than that of the sensing cavity.

The material of the spiral functional layer is one or more combinations of precious metals such as gold, platinum, platinum-iridium, etc.

The bearing layer material is a functional polymer material, selected from any one or a combination of Nafion, cellulose acetate, polyaniline, polypyrrole, polyphenol and derivatives thereof.

The surface of the piercing portion is coated with an insulating layer and an isolation layer, and the shape of the tip portion is not changed during coating.

compared to the existing technology. The advantages of the present invention are:

1. An implanted electrode for long-term continuous monitoring of the present invention, by selecting a material with strong rigidity as the base electrode, can be directly implanted with bare hands during the patient's use, and can reduce the need for implantation during the implantation process. It reduces the psychological burden of patients, improves product compliance, and promotes the use of continuous blood glucose monitoring products in diabetic patients in my country.

2. An implantable electrode used for long-term continuous monitoring of the present invention uses a very fine precious metal wire to wrap the base electrode to form a helical functional layer 1. Compared with the traditional needle electrode, the body surface area of the electrode can be increased. ratio, thereby increasing the number of immobilized glucose oxidase, and improving the electrical properties of stainless steel, thereby improving the signal-to-noise ratio and accuracy of the electrode.

3. An implanted electrode used for long-term continuous monitoring of the present invention uses an insulating layer to form a needle-type sensing cavity. During the sensor monitoring process, the fixed enzyme layer can be protected, and the rigidity of the implant can be kept at the same time. The sharpness of the needle tip can effectively alleviate the strong foreign body reaction caused by the implantation of the sharp needle tip, thereby improving the monitoring life of the sensor.

【Description of drawings】

Figure 1 is a structural diagram of the area division of the implantable electrode sensor for long-term continuous monitoring

In Figure 1:

1—Substrate electrode, 2—Sensing cavity, 3—Insulation layer, 4—Connecting contacts, 5—Spiral functional layer, 6—Signal enhancement layer, 7—Bearing layer, 8—Signal layer, 9—Isolation layer, 10 - The piercing part.

【Detailed ways】

The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

As shown in FIG. 1, an implantable electrode for long-term continuous monitoring includes: a base electrode 1, a sensing cavity 2, an insulating layer 3, a connecting contact 4, and a piercing portion 10; the sensing cavity 2 includes Spiral functional layer 5 , signal enhancement layer 6 , bearing layer 7 , signal layer 8 , isolation layer 9 .

The material of the base electrode 1 is rigid metal, the shape is needle-shaped, the diameter is between 0.1 and 0.5 mm, and the length is less than 10 cm; the insulating layer material is insulating polymer material, which is coated on the area outside the sensing cavity 2; the spiral functional layer 5. The material is noble metal modified on the base electrode 1; Any one or more combinations of the catalysts; the material of the isolation layer 9 is any one or more combinations of biocompatible polymer materials;

Wherein, the platinum nano-layer is prepared by electrodeposition. Electrolyte and deposition potential of different concentration ratios are used to electrodeposit platinum nanoparticles. The density of the platinum layer has an important effect.

The bearing layer is dripped with different capacities into the sensing cavity, wherein the dripped amount affects the thickness of the film layer and thus affects the body surface area ratio and active sites.

By controlling the distribution of the signal enhancement layer and the thickness of the carrier layer, a pore structure adapted to the size of the catalytic species in the signal layer is formed, thereby providing a higher body surface area ratio and immobilizing the excess catalytic species in a more stable manner, thereby improving the monitoring life of the sensor. , to reduce the patient's fear and economic burden caused by frequent sensor replacement.

It should be noted that the above embodiments are only used to illustrate the description of the free-hand implantable spiral microneedle sensing electrode of the patent of the present invention, rather than a limitation of the patent of the present invention. It should be understood by those of ordinary skill in the art that the technical solutions of the present design can be modified or equivalently replaced without departing from the spirit and scope of the technical solutions of the present invention, which should be included in the scope of the claims of the present invention.

Claims (7)

1. An implantable electrode for long-term continuous monitoring, characterized in that the electrode comprises a base electrode (1), a sensing cavity (2), an insulating layer (3), a connection contact (4), a stab an inlet portion (10); the sensing cavity (2) is located in the middle of the electrode, and both ends are covered by an insulating layer to form a structure with high ends and a low middle; the sensing cavity (2) includes a spiral functional layer (5) ), a signal enhancement layer (6), a bearing layer (7), a signal layer (8), and an isolation layer (9); the material of the spiral functional layer (5) is a noble metal modified on the base electrode (1); the signal The material of the enhancement layer (6) is noble metal nanoparticles, which are modified on the helical functional layer (5) and the base electrode (1); the material of the signal layer (8) is any one or more combinations of the reaction catalysts; The material of the isolation layer (9) is any one or a combination of hydrophilic functional materials; the surface of the piercing portion (10) is uniformly coated with an insulating protective layer (3) and an isolation layer (9). 2 . The implantable electrode for long-term continuous monitoring according to claim 1 , wherein the base electrode ( 1 ) is made of rigid metal, has a needle shape, and has a diameter of between 0.1 and 0.5 mm. 3 . , the length is less than 10cm. 3. The implantable electrode for long-term continuous monitoring as claimed in claim 1, wherein the insulating layer (3) is made of insulating polymer material, and is coated on the surface outside the sensing cavity (2). area. 4. The implantable electrode for long-term continuous monitoring according to claim 1, wherein the coating thickness of the insulating layer (3) is larger than that of the sensing cavity (2). 5. The implanted electrode for long-term continuous monitoring according to claim 1, wherein the material of the spiral functional layer (5) is one or more of precious metals such as gold, platinum, platinum-iridium, etc. kind of combination. 6. The implantable electrode for long-term continuous monitoring as claimed in claim 2, wherein the material of the bearing layer (7) is a functional polymer material, selected from Nafion, cellulose acetate, polyaniline, polypyrrole, polyvalent Any one or more combinations of phenol and its derivatives. 7 . The implantable electrode for long-term continuous monitoring according to claim 2 , wherein the surface of the piercing portion is coated with an insulating layer and an isolation layer, and the shape of the tip portion is not changed during coating. 8 .