WO2020155082A1

WO2020155082A1 - Subcutaneous interventional sensor implanting apparatus and implanting method, and monitoring method and system

Info

Publication number: WO2020155082A1
Application number: PCT/CN2019/074364
Authority: WO
Inventors: 张亚南; 杨凯洪; 张笑宇; 段国宏
Original assignee: 浙江凯立特医疗器械有限公司
Priority date: 2019-02-01
Filing date: 2019-02-01
Publication date: 2020-08-06

Abstract

A subcutaneous interventional sensor apparatus, comprising a mounting base (10), an insertion device (20), and a sensor (30). The insertion device is removably connected to the mounting base, the insertion device is rotated so that the mounting device lifts skin (100) below the mounting base upward to form a suitable implanting angle, and the insertion device implants an electrode detection portion (31) of the sensor into a subcutaneous tissue. The sensor apparatus can not only conveniently adjust the angle and depth of the same sensor when implanted in different body parts and ensure the accuracy and stability of monitoring data, the sensor apparatus is also applicable to implant sensors with different lengths into a predetermined subcutaneous tissue site without piercing a muscle layer. Further provided are an implanting method for the subcutaneous interventional sensor apparatus, and a monitoring method and system. According to the monitoring system and method, a measured object signal is monitored in real time by using an interventional sensor, and signal data is transmitted to a display terminal for facilitating a user to view the monitoring data in real time.

Description

Subcutaneous interventional sensor implantation device, implantation method, monitoring method and system

Technical field

The present invention relates to the technical field of medical equipment, and more specifically, to a subcutaneous interventional sensor device, a subcutaneous interventional sensor implantation method, a monitoring system and a monitoring method.

Background technique

Clinically, in order to monitor the changes in molecular concentration in the human body, while avoiding the introduction of greater risk of systemic infection, the method of micro-probe detectors is often used to leave in the subcutaneous tissue for a certain period of time. Conduct continuous monitoring.

The surface layer of the skin is the epidermis, and the epidermis has no blood circulation, so it is generally impossible to detect the physiological concentration parameters of molecular ions. Below the epidermis is the dermis. The dermis is the main nerve endings, small blood vessels, capillaries, hair follicles and other areas that maintain the normal physiological functions of the skin, and has the highest degree of temperature, pain, and stimulus perception. Below is the subcutaneous tissue layer (also known as the subcutaneous layer). The subcutaneous tissue layer is a stable fat layer composed of connective tissue fibers and fat cells. It is generally not affected by the deformation of the muscles below it. Its physiological function is to maintain Body shape, maintain a constant temperature, store fat, distribute small blood vessel network, provide skin circulation, etc. Below the subcutaneous tissue layer is the muscle layer. Generally speaking, the electrode detection part of the interventional sensor needs to be implanted in the subcutaneous tissue layer to continuously monitor the measured object, and cannot enter the muscle layer.

At present, the sensors used for subcutaneous tissue fluid monitoring are implanted directly through the skin at a certain angle, or because the sensor itself is hard, or because the piercing aid is a hard needle, the sensors are all linear The method is left in the subcutaneous tissue. The thickness of the subcutaneous tissue layer of most normal people is limited, except for the thicker abdominal fat, other parts such as the upper arm are generally 2-5mm. In order to prevent the sensor from entering deep muscles, it is necessary to limit the length of the sensor and use a shorter sensor. However, because different people have the same body part and different body parts of the same person, due to their physiological characteristics, the thickness of their skin and subcutaneous layers are different. Therefore, the electrode detection part of the existing sensor cannot be universally applied to different body parts or different people due to the limitation of length.

In addition, in order to maintain an effective signal-to-noise ratio, the sensor signal amplitude (or sensitivity) must be kept not lower than a certain threshold, otherwise the environment or inherent noise of the circuit will interfere with the accuracy and reliability of the sensor. The limited length of the sensor means that its effective electrode surface area is limited, which will affect the accuracy and reliability of the sensor. If the length of the electrode detection part of the sensor is increased, in order not to enter the muscle layer, the application range of the sensor can only be limited. For example, the overall length of the Dekang sensor exceeds 8mm. Even if it is inserted at an oblique angle, it can only be used for thick fat Therefore, the sensor can only be designated for the abdomen, and cannot be used for the upper arm or other parts with a thin layer of subcutaneous tissue.

Therefore, when the electrode detection part of the sensor is long enough, how to ensure that it can be applied to different people or different body parts is a technical problem to be solved by those skilled in the art.

Summary of the invention

In view of this, the purpose of the present invention is to provide a subcutaneous interventional sensor device, which can implant the interventional sensor in different body parts, and can be implanted to a predetermined depth as required, so as to ensure the accuracy and stability of the monitoring data.

Another object of the present invention is to provide a subcutaneous interventional sensor implantation method, which can simply and conveniently implant the sensor into the subcutaneous tissue of different body parts or different people without penetrating the muscle layer, ensuring that the sensor is working Accuracy and reliability.

Another object of the present invention is to provide a monitoring system and method, which utilizes interventional sensors to monitor the signal of the object under test in real time, and transmits the signal data to the display terminal, which is processed and analyzed and presented to the user in a visual manner.

In order to achieve the above objective, the present invention provides the following technical solutions:

A subcutaneous interventional sensor device, including:

The mounting seat has an adhesive layer on part or all of the contact surface with the skin, which can be driven by external force to pull up part or all of the skin below it to form a suitable implant angle;

The sensor includes an electrode detection part, a signal receiving part, and a sensor fixing block. The electrode detection part is implanted in the subcutaneous tissue to collect the detection signal of the object to be measured. The sensor fixing block is left outside the skin to fix the sensor. The signal receiving part Set in the sensor fixed block to receive the detected object detection signal;

The needle aid is detachably connected to the mounting seat and is used for implanting the electrode detection part of the sensor into the subcutaneous tissue.

Further, the mounting seat includes a base.

Further, the needle aid is detachably connected to the base, and the base is provided with a fixed block locking sleeve for docking with the sensor fixed block, and the fixed block locking sleeve is hingedly arranged on the On the pedestal.

Further, the mounting seat further includes a gusset plate, and one end of the base and one end of the gusset plate are relatively rotatably connected.

Further, the needle aid is detachably connected to the gusset plate, and the gusset plate is provided with a fixing block locking sleeve for connecting with the sensor fixing block, and the fixing block locking sleeve is hingedly arranged on the Gusset.

Further, it also includes a housing, which is a hollow housing with a rotation port at the top and an implant port at the bottom; the needle aid passes through the rotation port and is hinged with the housing.

Further, the needle aid includes an elastic retracting device, a half-wall needle and a half-wall needle fixing block; the elastic retracting device includes an elastic device and a release button, and the elastic device is used to drive the half-wall needle fixing block to achieve The half-wall needle penetrates the subcutaneous tissue, the release button is used to release the elastic potential energy of the elastic device; the half-wall needle is inserted into the sensor fixing block and the electrode detection part is wrapped in the needle tube, The electrode detection part is implanted into the subcutaneous tissue in a puncture method; the half-wall needle fixing block is connected with the half-wall needle, and the half-wall needle is used for penetrating and removing the subcutaneous tissue.

Further, the release end of the rotation port is provided with a trigger protrusion, the release button is provided at a corresponding position of the needle aid, and when the needle aid rotates to the release end, the trigger protrusion triggers the release Button.

Further, it also includes a wireless communication module connected to the signal receiving unit.

Further, it also includes a cover detachably arranged on the mounting seat.

A subcutaneous interventional sensor implantation method is characterized in that it comprises:

Stick the base closely to the skin surface;

The needle aid is fixedly connected with the gusset plate, and the needle aid is rotated so that the gusset plate and the base rotate relative to each other, and the gusset plate drives the base to lift the skin below it; and

By rotating the needle aid to adjust to a suitable implantation angle, the electrode detection part of the sensor is implanted into the subcutaneous tissue.

Further, after implanting the electrode detection part of the sensor into the subcutaneous tissue, the method further includes: separating the needle aid from the pinch plate, and returning the skin that has been pulled up to a normal state.

Further, after the needle aid is adjusted to an appropriate implant angle by rotating the needle aid, the elastic retracting device is triggered to drive the half-wall needle into the subcutaneous tissue, the electrode detection part of the sensor enters the subcutaneous tissue through the half-wall needle, and then exits the half-wall needle and removes the The electrode detection part is left in the subcutaneous tissue.

Further, when the needle aid is rotated to the release end of the rotation port of the housing, the release button on the needle aid contacts the triggering bump, and the elastic device is automatically triggered to drive the half-wall needle to penetrate the subcutaneous tissue.

A monitoring system includes:

Subcutaneous interventional sensor device as in any of the foregoing; and

The display device is configured to communicate with the subcutaneous interventional sensor device in wired or wireless communication, and is used to receive the measured object detection signal data sent by the sensor device, and process, analyze and visually display the data.

A monitoring method includes:

Implant the subcutaneous interventional sensor into the subcutaneous tissue using the implantation method described in any one of the foregoing;

The subcutaneous interventional sensor collects and receives the detection signal of the measured object in real time;

Transmitting the detected object detection signal data to the display device in a wired or wireless manner; and

The display device processes and analyzes the received data for visual display.

The present invention provides a subcutaneous interventional sensor device, comprising a mounting seat, a needle aid and a sensor. The mounting seat is pasted on the surface of the skin. The needle aid is detachably connected to the mounting seat and then the skin is lifted upward to form a suitable The sensor is implanted into the subcutaneous tissue. During implantation, the required implantation angle is adjusted by rotating the needle aid, so that the electrode detection part of the sensor is implanted into the required subcutaneous tissue depth without penetrating the muscle layer, ensuring the accuracy and reliability of the sensor during operation Sex.

The present invention provides a subcutaneous interventional sensor implantation method. The base (or the base and the gusset) is pasted on the skin surface, and then the needle aid is detachably fixed to the base (or the gusset), Rotate the needle aid to lift the skin up to form an implantation surface, and then implant the electrode detection part of the sensor into the subcutaneous tissue. This method can not only easily adjust the angle and depth of the same sensor when implanted in different body parts, ensure the accuracy and stability of the monitoring data, but also be suitable for implanting sensors of different lengths into predetermined subcutaneous tissues without piercing Muscle layer.

The monitoring system and method provided by the present invention use an interventional sensor to monitor the signal of the object under test in real time, and transmit the signal data to the display terminal, which is processed and analyzed and presented to the user in a visual manner, which is convenient for the user to view and monitor in real time data.

Description of the drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only It is an embodiment of the present invention. For those of ordinary skill in the art, other drawings can be obtained according to the provided drawings without creative work.

Figure 1 is a schematic diagram of the implantation method of a subcutaneous interventional sensor in the prior art;

2 is a schematic diagram of a subcutaneous interventional sensor device in Embodiment 1 of the present invention;

3 is a schematic diagram of the implantation process of the subcutaneous interventional sensor in the first embodiment of the present invention;

4 is a schematic diagram of the structure of the locking sleeve of the fixed block in the embodiment of the present invention;

Fig. 5 is a schematic diagram of the implanted state of the interventional sensor in the embodiment of the present invention.

6 is a schematic diagram of a subcutaneous interventional sensor device in the second embodiment of the present invention;

7 is a schematic diagram of the implantation process of the subcutaneous interventional sensor in the second embodiment of the present invention;

Figure 8 is a schematic diagram of the sensor structure of the present invention;

Figure 9 is a schematic diagram of a subcutaneous interventional sensor device with a housing in an embodiment of the present invention;

10 is a schematic diagram of a subcutaneous interventional sensor device in Embodiment 3 of the present invention;

11 is a schematic diagram of the implantation process of the subcutaneous interventional sensor in the third embodiment of the present invention;

12 is a schematic diagram of a subcutaneous interventional sensor device in Embodiment 4 of the present invention;

Figure 13 is a schematic diagram of the implantation process of the subcutaneous interventional sensor in the fifth embodiment of the present invention.

Among them, the signs in the drawings are as follows:

10-mounting seat, 11-base, 12-gusset, 13-fixed block locking sleeve, 20-needle aid, 21-half-wall needle, 22-half-wall needle fixed block, 23-elastic retractable device, 231-elastic Device, 232-release button, 30-sensor, 31-electrode detection part, 32-sensor fixing block, 33-signal receiving part, 40-housing, 41-rotation port, 42-implantation port, 43-trigger bump, 411-release end, 100-skin.

detailed description

The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

Please refer to FIGS. 1 to 11. FIG. 1 is a schematic diagram of an interventional sensor implantation method in the prior art; FIG. 2 is a schematic diagram of a subcutaneous interventional sensor device in Embodiment 1 of the present invention; FIG. 3 is a subcutaneous intervention in Embodiment 1 of the present invention Fig. 4 is a schematic diagram of the structure of the locking sleeve of the fixed block in the embodiment of the present invention; Fig. 5 is a schematic diagram of the implanted state of the interventional sensor in the embodiment of the present invention. 6 is a schematic diagram of the subcutaneous interventional sensor device in the second embodiment of the present invention; FIG. 7 is a schematic diagram of the implantation process of the subcutaneous interventional sensor in the second embodiment of the present invention; FIG. 8 is a schematic diagram of the sensor structure of the present invention; FIG. 9 is an embodiment of the present invention Fig. 10 is a schematic diagram of the subcutaneous interventional sensor device in the third embodiment of the present invention; Fig. 11 is a schematic diagram of the subcutaneous interventional sensor implantation process in the third embodiment of the present invention; Fig. 12 is the present invention The schematic diagram of the subcutaneous interventional sensor device in the fourth embodiment; FIG. 13 is a schematic diagram of the implantation process of the subcutaneous interventional sensor in the fifth embodiment of the present invention.

As shown in FIG. 1, in the prior art, the implanter implants the electrode detection part of the sensor into the subcutaneous tissue at a certain inclination angle, so that the electrode detection part is still in a linearly straightened state in the skin. If the electrode detection part is long, it will easily cause it to cross the subcutaneous tissue layer, and insert the muscle layer, which will eventually lead to excessive monitoring errors.

As shown in FIGS. 2, 3, 6, and 7, the present invention proposes a subcutaneous interventional sensor device, which includes a mounting base 10, a needle aid 20 and a sensor 30. Wherein, part or all of the contact surface between the mounting seat 10 and the skin 100 is provided with an adhesive layer, which can be driven by an external force to pull up the corresponding part or all of the skin 100 underneath to form a suitable implant angle to form a Implantation surface. The needle aid 20 is detachably connected to the mounting base 10, and the electrode detection part of the sensor is implanted into the subcutaneous tissue from the implantation surface.

As shown in FIG. 8, the sensor 30 includes an electrode detection part 31, a sensor 30 fixing block 32 and a signal receiving part 33. The electrode detection unit 31 is implanted in the subcutaneous tissue to collect the detection signal of the test object, the sensor fixing block 32 is left outside the skin 100 for fixing the sensor 30, and the signal receiving unit 33 is provided in the sensor fixing block 32 for use To receive the detection signal of the measured object. The electrode detection part 31 of the sensor 30 is made of flexible material, has flexibility, and can be bent accordingly when implanted in the subcutaneous tissue. The signal receiving unit is a signal receiving circuit, connected to the electrode detection unit 31, and receives the collected signal. The sensor 30 can be an existing chemical sensor for detecting molecular and ion signals in various subcutaneous tissues, such as a glucose sensor.

The mounting base 10 includes a base 11. The contact surface of the base 11 and the skin 100 is provided with an adhesive layer, which can tightly bond the base 11 and the skin 100 in contact. At this time, the needle aid 20 is detachably and fixedly connected to the base 11, and when the needle aid 20 is rotated, the skin 100 (the skin below the base) tightly bonded to the base 11 Pull up to form a certain angle, so that the electrode detection part 31 of the sensor 30 is implanted into the subcutaneous tissue, and the implantation angle can be adjusted through the base 11 to be suitable for different parts of the body or the same body part of different individuals. The adhesive layer may be an adhesive layer formed by various types of adhesives in the prior art, and is preferably an adhesive that is non-irritating and harmless to the skin, such as medical tape.

The mounting base 10 may further include a buckle plate 12, one end of the buckle plate 12 and one end of the base 11 can be relatively rotatably connected, and the connection method may be a method in the prior art, such as hinged connection by a rotating shaft. At this time, the needle aid 20 is detachably and fixedly connected to the buckle plate 12. When the needle aid 20 is rotated, the buckle plate 12 and the base 11 are relatively rotated, and the buckle plate 12 drives the base 11 to hold it. The tightly bonded skin 100 below is pulled up, so that the base 11 and the skin 100 under the gusset 12 form an upward bulge. The contact surface of the gusset 12 and the skin 100 is the implantation surface, and the electrode detection part 31 of the sensor 30 The subcutaneous tissue is implanted from the implant surface. The buckle plate 12 can be used to drive the base 11 to adjust the implantation angle and depth in linkage, so as to be suitable for different parts of the body or the same body part of different individuals. Preferably, an adhesive layer may also be provided on the contact surface of the gusset 12 and the skin 100, which will facilitate the lifting of the contacted skin 100 to form a suitable implant angle.

Preferably, the needle aid 20 includes a half-wall needle 21 and a half-wall needle fixing block 22, and the half-wall needle fixing block 22 is connected to the half-wall needle 21. The half-wall movable needle is inserted into the sensor fixing block 32, and the electrode detection part 31 is wrapped in the needle tube. When the sensor 30 is implanted, the power device in the needle aid 20 drives the half-wall needle 21 into the subcutaneous tissue layer through the half-wall needle fixing block 22, thereby implanting the electrode detection part 31 wrapped therein into the subcutaneous tissue, and then the half-wall needle 21 The subcutaneous tissue is removed, and the electrode detection part 31 is left in the subcutaneous tissue.

Preferably, the power device of the needle aid 20 may be an elastic retracting device 23 for driving the half-wall needle fixing block 22 to realize the penetration of the half-wall needle 21.

The measured object detection signal data collected by the sensor 30 can be transmitted to other paired terminals through wired or wireless communication, and then the data receiving terminal processes and analyzes the data, and visually displays it externally for easy observation. The terminal may be a specially configured smart device, or an existing smart terminal, such as a smart phone, a computer, etc. For ease of use, preferably, the sensor 30 device can be equipped with a wireless communication module, which can transmit data wirelessly and also accept operation instructions from the terminal. The wireless communication module may be an existing wireless data communication module, such as a WIFI module, a 2/3/4G module, an infrared module, a Bluetooth module, a near field communication module, etc.

In order to provide power to the sensor 30 device, a power supply device can be provided on the base 11 or the gusset 12. Preferably, the power supply device can be an existing button battery, which can provide sufficient electric energy, and is small in size and light in weight.

The present invention also provides a monitoring system that utilizes interventional sensors to continuously monitor the signal of the measured object in real time and displays related monitoring data to the user, including the aforementioned subcutaneous interventional sensor device and display device. Wherein, the display device is configured for wired or wireless communication with the subcutaneous interventional sensor device, and is used to receive the detected object detection signal data sent by the sensor device, and process, analyze and visually display the data. In addition, the display device can also be used to send control instructions to the subcutaneous interventional sensor device.

Example one

As shown in FIGS. 2 and 3, a subcutaneous interventional sensor device in this embodiment includes: a mounting base 10, a needle aid 20, and a sensor 30. The mounting base 10 includes a base 11 and a gusset 12.

In this embodiment, the contact surface between the base 11 and the skin 100 is provided with an adhesive layer, which can be adhered to the surface of the skin 100 of the user.

In this embodiment, the gusset 12 is hinged to the base 11 and can be rotated relative to the base 11, and an adhesive layer is also provided on the contact surface of the gusset 12 and the skin 100 for tight adhesion with the skin 100. On the one hand, the pinch plate 12 can be fixed on the skin 100, which is convenient for use in the monitoring process. On the other hand, the needle aid 20 drives the base 11 to rotate by driving the pinch plate 12 to be more convenient.

In this embodiment, the needle aid 20 is detachably combined with the pinch plate 12. The needle aid 20 includes an elastic retracting device 23, a half-wall needle 21 and a half-wall needle fixing block 22. Wherein, the elastic retracting device 23 drives the half-wall needle 21 to penetrate the subcutaneous tissue layer by driving the half-wall needle fixing block 22, thereby implanting the electrode detection part 31 wrapped therein into the subcutaneous tissue, and then withdrawing the half-wall needle 21 from the subcutaneous tissue, and The electrode detection part 31 is left in the subcutaneous tissue. The elastic retracting device 23 includes an elastic device 231 and a release button 232. In the unused state, the elastic device 231 is in a compressed state and has elastic potential energy stored. When in use, the elastic device 231 is stretched extremely quickly by pressing the release button 232 to convert the elastic potential energy into the kinetic energy of the half-wall needle fixing block 22, thereby piercing the half-wall needle 21 into the subcutaneous tissue, and then separating the needle aid 20 from the gusset 12, Drive the half-wall needle 21 to extract the subcutaneous tissue to complete the implantation operation.

In this embodiment, the sensor 30 includes an electrode detection part 31, a signal receiving part 33 and a sensor fixing block 32. The electrode detection part 31 is made of a flexible material. Since the electrode detection part 31 is implanted into the subcutaneous tissue that is pulled up at a certain angle, when the skin 100 returns to the original flat state after the implantation is completed, the flexible electrode detection part 31 A certain degree of curvature is formed in the skin 100, so that it will not penetrate the muscle layer, and can also maintain an effective detection length, thereby ensuring the accuracy of the detection data.

In this embodiment, as shown in FIG. 4, the buckle plate 12 is further provided with a fixed block locking sleeve 13 that is connected to the sensor fixing block 32, and the fixed block locking sleeve 13 is hingedly arranged on the buckle plate. 12 on. The fixed block locking sleeve 13 wraps a part of the sensor fixed block 32. After the implantation is completed, the fixed block locking sleeve 13 is rotated and set to a state substantially parallel to the gusset plate 12, thereby fixing the sensor fixing block 32 to a certain extent. Protective effects.

In this embodiment, in order to provide power to the sensor 30, a button battery is provided on the base 11.

In this embodiment, in order to isolate the sensor 30 and the button battery from the external environment and play a protective role to prevent environmental factors from affecting its normal operation, a detachable cover is provided on the base 11 and the gusset 12. The cover body and the base 11 and the gusset 12 can be connected by sliding rails and sliding grooves, or by snapping, or by other existing detachable connections. In addition, in addition to covering and protecting the cover, the connection between the cover and the gusset 12 and the base 11 can also be used to match the rigidity of the cover itself to prevent the base 11. The purpose of relative rotation with the gusset 12. Therefore, the cover has the function of fixing the buckle plate 12 and the base 11 on the one hand, and also has the function of protecting the structure of the sensor 30 on the other hand.

In this embodiment, the sensor device further includes a wireless communication module, the wireless communication module is connected to the signal receiving part 33 and may be arranged on the base 11 or the gusset 12.

This embodiment also provides a subcutaneous interventional sensor implantation method, including:

S11, the base 11 is closely adhered to the surface of the skin 100. The specific method is as follows: an adhesive layer is provided on the contact surface of the base 11 and the skin 100, and the base 11 is closely adhered to the surface of the skin 100 through the adhesive layer.

Preferably, an adhesive layer is also provided on the contact surface of the gusset 12 and the skin 100, and the gusset 12 is also closely adhered to the surface of the skin 100 through the adhesive layer, which facilitates the subsequent rotation and lifting operations of the needle aid 20 .

S12, the needle aid 20 is fixedly connected with the buckle plate 12, and the needle aid 20 is rotated so that the buckle plate 12 and the base 11 rotate relatively, and the buckle plate 12 drives the base 11 to lift the tightly bonded skin 100 below it. , So that the base 11 and the skin 100 under the gusset 12 form an upward protrusion, and the base 11 and the gusset 12 are respectively attached to the two sides of the protrusion.

S13, by rotating the needle aid 20 to adjust to an appropriate implantation angle, the electrode detection portion 31 of the sensor 30 is implanted into the subcutaneous tissue from the side where the gusset 12 is attached. The specific method is as follows: after the needle aid 20 is rotated to adjust to a suitable implantation angle, the elastic retractable device 23 is triggered to drive the half-wall needle 21 into the subcutaneous tissue, and the electrode detection part 31 of the sensor 30 enters the subcutaneous tissue through the half-wall needle 21, and then Withdraw the half-wall needle 21 and leave the electrode detection part 31 in the subcutaneous tissue.

In addition, the implantation method further includes: S14, separating the needle aid 20 from the pinch plate 12, and returning the skin 100 pulled up to a normal state. As shown in FIG. 5, since the electrode detection part 31 is made of a flexible material, after the implantation is completed, the skin 100 returns to its original flat state, and finally, the flexible electrode detection part 31 forms a certain degree of curvature in the skin 100. According to actual monitoring needs, the implantation angle of the sensor 30 can be adjusted by the degree to which the skin 100 is pulled up, so that the flexible electrode detection portion 31 finally forms a bend of different angles in the skin 100. When the sensor detection part is long enough, it can not only prevent it from penetrating into the muscle layer, but also adjust the depth of penetrating into the subcutaneous tissue layer, so as to monitor the detection signal of the test object at different positions.

This embodiment also provides a monitoring method for real-time continuous monitoring of the test object in the subcutaneous tissue, including:

S110, implanting the subcutaneous interventional sensor 30 into the subcutaneous tissue using the implantation method described in one of the embodiments;

S120, the subcutaneous interventional sensor 30 collects and receives the detection signal of the measured object in real time;

S130: Transmit the detected object detection signal data to the display device in a wired or wireless manner.

S140: The display device processes and analyzes the received data and performs a visual display.

Preferably, the display device is a smart phone that performs wireless communication with a wireless communication module, and the smart phone is equipped with software specially used to process and analyze the detection signal data of the measured object. After the data processing and analysis are completed, it is performed on the smart phone. Visual display.

Example two

As shown in FIGS. 6 and 7, a subcutaneous interventional sensor device in this embodiment includes: a mounting base 10, a needle aid 20 and a sensor 30. The mounting base 10 includes a base 11.

In this embodiment, the needle aid 20 is detachably combined with the base 11. The needle aid 20 includes an elastic retracting device 23, a half-wall needle 21 and a half-wall needle fixing block 22, and the specific structure is the same as that described in the first embodiment.

In this embodiment, the sensor 30 includes an electrode detection part 31, a signal receiving part 33 and a sensor fixing block 32. The electrode detection part 31 is made of a flexible material.

In this embodiment, the base 11 is provided with a fixed block locking sleeve 13 that is connected to the sensor fixed block 32, and the fixed block locking sleeve 13 is hingedly arranged on the base 11. The fixed block locking sleeve 13 wraps a part of the sensor fixed block 32. After the implantation is completed, the fixed block locking sleeve 13 is rotated and set to a state substantially parallel to the gusset 12, so that the sensor fixed block 32 can be fixed and combined. Protective effects.

In this embodiment, similar to the first embodiment, a detachable cover is provided on the base 11.

S21, the base 11 is closely adhered to the surface of the skin 100. The specific method is as follows: an adhesive layer is provided on the contact surface of the base 11 and the skin 100, and the base 11 is closely adhered to the surface of the skin 100 through the adhesive layer.

S22, the needle aid 20 is fixedly connected with the base 11, and the needle aid 20 is rotated so that the base 11 lifts the skin 100 underneath it upward, and the skin 100 attached under the base 11 forms an inclined implant surface.

S23, by rotating the needle aid 20 to adjust to an appropriate implantation angle, the electrode detection portion 31 of the sensor 30 is implanted into the subcutaneous tissue from the skin 100 fitted under the base 11. The specific method is as follows: after the needle aid 20 is rotated to adjust to a suitable implantation angle, the elastic retractable device 23 is triggered to drive the half-wall needle 21 into the subcutaneous tissue, and the electrode detection part 31 of the sensor 30 enters the subcutaneous tissue through the half-wall needle 21, and then Withdraw the half-wall needle 21 and leave the electrode detection part 31 in the subcutaneous tissue.

In addition, the implantation method further includes: S24, separating the needle aid 20 from the base 11, and the skin 100 pulled up by the base 11 returns to a normal state. Since the electrode detection part 31 is made of a flexible material, after the implantation is completed, the skin 100 returns to its original flat state, and finally, the flexible electrode detection part 31 forms a certain degree of curvature in the skin 100. According to actual monitoring needs, the implantation angle of the sensor 30 can be adjusted by the degree to which the skin 100 is pulled up, so that the flexible electrode detection portion 31 finally forms a bend of different angles in the skin 100. When the sensor detection part is long enough, it can not only prevent it from penetrating into the muscle layer, but also adjust the depth of penetrating into the subcutaneous tissue layer, so as to monitor the detection signal of the test object at different positions.

S210, using the implantation method described in the second embodiment to implant the subcutaneous interventional sensor 30 into the subcutaneous tissue;

S220, the subcutaneous interventional sensor 30 collects and receives the detection signal of the measured object in real time;

S230: Transmit the detected object detection signal data to the display device in a wired or wireless manner.

S240: The display device processes and analyzes the received data and performs a visual display.

Example three

As shown in FIGS. 9, 10 and 11, a subcutaneous interventional sensor device in this embodiment, on the basis of the first embodiment, the device further includes a housing 40.

The housing 40 is hinged to the needle aid 20 to limit the rotation angle of the needle aid 20 and facilitate the control of the implantation angle of the sensor 30. The shell 40 is a hollow shell with a rotation port 41 at the top and an implant port 42 at the bottom. After the lower part of the needle aid 20 is combined with the base 11 through the implant port 42, the lower plane of the housing 40 is attached to the skin 100 to play a certain supporting and stabilizing role. The upper part of the needle aid 20 passes through the rotation port 41. When the sensor 30 is implanted, the upper part of the needle aid 20 is rotated so that the needle aid 20 rotates along the trajectory defined by the rotation port 41. When the release end 411 of the rotation port 41 is reached, the optimal sensor 30 implantation is achieved Angle, at this time, implanting the sensor 30 into the subcutaneous tissue can achieve the best detection effect.

Preferably, for further convenience of use, a trigger protrusion 43 may be provided at the release end 411 of the rotation port 41, and the release button 232 may be provided at a corresponding position of the needle aid 20. When the needle aid 20 rotates to the release end 411 of the rotation port 41, the release button 232 touches the trigger protrusion 43, thereby releasing the elastic device 231 to pierce the half-wall needle 21 into the subcutaneous tissue.

In order to further save the amount of material used in the housing 40, the housing 40 can be further simplified. It only has two opposite side walls and a top wall. The implant port 42 is formed under the two opposite side walls, and the top wall is provided with a rotation口41.

In this embodiment, a subcutaneous interventional sensor implantation method includes:

S31, the base 11 and the gusset 12 are closely adhered to the surface of the skin 100.

S32, the needle aid 20 is fixedly connected with the gusset plate 12, and the needle aid 20 is rotated so that the gusset plate 12 and the base 11 rotate relatively, and the gusset plate 12 drives the base 11 to lift the tightly bonded skin 100 below it. , So that the base 11 and the skin 100 under the gusset 12 form an upward protrusion, and the base 11 and the gusset 12 are respectively attached to the two sides of the protrusion.

S33: When the needle aid 20 is rotated to the release end 411 of the rotation port 41 of the housing 40, the electrode detection portion 31 of the sensor 30 is implanted into the subcutaneous tissue from the side where the gusset 12 is attached. The specific method is: when the needle aid 20 rotates to the release end 411 of the rotation port 41 of the housing 40, the elastic retracting device 23 is triggered to drive the half-wall needle 21 into the subcutaneous tissue, and the electrode detection part 31 of the sensor 30 enters the subcutaneous tissue through the half-wall needle 21 Tissue, then withdraw the half-wall needle 21 and leave the electrode detection part 31 in the subcutaneous tissue.

Preferably, when the needle aid 20 rotates to the release end 411 of the rotation port 41 of the housing 40, the release button 232 on the needle aid 20 contacts the trigger protrusion 43, and the elastic retractable device 23 is automatically triggered to drive the half-wall needle 21 to penetrate The subcutaneous tissue simplifies the implantation operation and improves the automation degree of the implantation operation.

In addition, the implantation method further includes: S34, separating the needle aid 20 from the pinch plate 12, and returning the skin 100 pulled up to a normal state.

S310, using the implantation method described in the third embodiment to implant the subcutaneous interventional sensor 30 into the subcutaneous tissue;

S320, the subcutaneous interventional sensor 30 collects and receives the detection signal of the measured object in real time;

S330: Transmit the detected object detection signal data to the display device in a wired or wireless manner.

S340: The display device processes and analyzes the received data and performs a visual display.

Example four

As shown in FIGS. 9, 12 and 13, a subcutaneous interventional sensor device in this embodiment, on the basis of the second embodiment, the device further includes a housing 40.

Preferably, in order to further save the amount of material used in the housing 40, the housing 40 can be further simplified and only has two opposite side walls and a top wall. The implant port 42 is formed under the two opposite side walls. A rotating port 41 is provided on it.

S41, the base 11 is closely adhered to the surface of the skin 100.

In S42, the needle aid 20 is fixedly connected to the base 11, and the needle aid 20 is rotated, and the base 11 lifts the skin 100 below it, so that the skin 100 attached to the base 11 forms an inclined implant surface.

S43: When the needle aid 20 is rotated to the release end 411 of the rotation port 41 of the housing 40, the electrode detection portion 31 of the sensor 30 is implanted into the subcutaneous tissue from the skin 100 fitted under the base 11. The specific method is: when the needle aid 20 rotates to the release end 411 of the rotation port 41 of the housing 40, the elastic retracting device 23 is triggered to drive the half-wall needle 21 into the subcutaneous tissue, and the electrode detection part 31 of the sensor 30 enters the subcutaneous tissue through the half-wall needle 21 Tissue, then withdraw the half-wall needle 21 and leave the electrode detection part 31 in the subcutaneous tissue.

In addition, the implantation method further includes: S44, separating the needle aid 20 from the pinch plate 12, and returning the skin 100 pulled up to a normal state.

S410, using the implantation method described in the fourth embodiment to implant the subcutaneous interventional sensor 30 into the subcutaneous tissue;

S420, the subcutaneous interventional sensor 30 collects and receives the detection signal of the measured object in real time;

S430: Transmit the detected object detection signal data to the display device in a wired or wireless manner.

S440: The display device processes and analyzes the received data and performs a visual display.

The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined in this document can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown in this text, but should conform to the widest scope consistent with the principles and novel features disclosed in this text.

Claims

A subcutaneous interventional sensor device, characterized in that it comprises:

The mounting seat has an adhesive layer on part or all of the contact surface with the skin, which can be driven by external force to pull up part or all of the skin below it to form a suitable implant angle;

The sensor includes an electrode detection part, a signal receiving part, and a sensor fixing block. The electrode detection part is implanted in the subcutaneous tissue to collect the detection signal of the test object. The sensor fixing block is left outside the skin to fix the sensor. The receiving part is arranged in the sensor fixing block to receive the detection signal of the measured object;

The needle aid is detachably connected to the mounting seat, and is used to implant the electrode detection part of the sensor into the subcutaneous tissue.
The subcutaneous interventional sensor device according to claim 1, wherein the mounting seat comprises a base.
The subcutaneous interventional sensor device according to claim 2, wherein the needle aid is detachably connected to the base, and the base is provided with a fixed block lock for docking with the sensor fixed block The fixing block locking sleeve is hingedly arranged on the base.
The subcutaneous interventional sensor device according to claim 2, wherein the mounting seat further comprises a gusset plate, and one end of the base and one end of the gusset plate are relatively rotatably connected.
The subcutaneous interventional sensor device according to claim 4, wherein the needle aid is detachably connected to the gusset plate, and the gusset plate is provided with a fixing block locking that connects to the sensor fixing block And the fixing block locking sleeve is hingedly arranged on the buckle plate.
The subcutaneous interventional sensor device according to any one of claims 1 to 5, further comprising a shell, the shell is a hollow shell with a rotation port on the top and an implant port on the bottom; The needle aid passes through the rotation port and is hinged with the housing.
The subcutaneous interventional sensor device of claim 6, wherein the needle aid includes an elastic retractable device, a half-wall needle and a half-wall needle fixing block; the elastic retractable device includes an elastic device and a release button, so The elastic device is used to drive the half-wall needle fixing block to realize the penetration of the half-wall needle into the subcutaneous tissue, and the release button is used to release the elastic potential energy of the elastic device; the half-wall needle is inserted into the sensor fixing block The electrode detection part is wrapped in a needle tube, and the electrode detection part is implanted into the subcutaneous tissue by puncture; the half-wall needle fixing block is connected with the half-wall needle for the half-wall needle to penetrate the subcutaneous tissue And withdraw from the subcutaneous tissue.
The subcutaneous interventional sensor device according to claim 7, wherein the release end of the rotation port is provided with a trigger bump, and the release button is provided at a corresponding position of the needle aid. When the actuator rotates to the release end, the trigger bump triggers the release button.
The subcutaneous interventional sensor device according to any one of claims 1 to 5, further comprising a wireless communication module connected to the signal receiving unit.
The subcutaneous interventional sensor device according to any one of claims 1 to 5, further comprising a cover detachably provided on the mounting seat.
A subcutaneous interventional sensor implantation method is characterized in that it comprises:

Stick the base closely to the skin surface;

The needle aid is fixedly connected to the base, and the needle aid is rotated so that the base pulls up the skin below it; and

By rotating the needle aid to adjust to a suitable implantation angle, the electrode detection part of the sensor is implanted into the subcutaneous tissue.
The implantation method of claim 11, wherein after the electrode detection part of the sensor is implanted into the subcutaneous tissue, the method further comprises: separating the needle aid from the base and pulling upward The skin returned to its normal state.
The implantation method of claim 11 or 12, wherein the elastic retractor triggers the half-wall needle to penetrate the subcutaneous tissue by rotating the needle aid to adjust to a suitable implant angle, and the sensor The electrode detection part enters the subcutaneous tissue through the half-wall needle, and then exits the half-wall needle and leaves the electrode detection part in the subcutaneous tissue.
The implantation method according to claim 13, wherein when the needle aid is rotated to the release end of the rotation port of the housing, the release button on the needle aid contacts the trigger bump to automatically trigger the elastic device Drive the half-wall needle into the subcutaneous tissue.
A subcutaneous interventional sensor implantation method is characterized in that it comprises:

Stick the base closely to the skin surface;

The needle aid is fixedly connected with the buckle plate, and the needle aid is rotated so that the buckle plate and the base rotate relatively, and the buckle plate drives the base to lift the skin underneath it upward; and

By rotating the needle aid to adjust to a suitable implantation angle, the electrode detection part of the sensor is implanted into the subcutaneous tissue.
The implantation method of claim 15, wherein after the electrode detection part of the sensor is implanted into the subcutaneous tissue, the method further comprises: separating the needle aid from the pinch plate and pulling upward The skin returned to its normal state.
The implantation method according to claim 15 or 16, characterized in that, after the needle aid is adjusted to an appropriate implant angle by rotating the needle aid, the elastic retracting device is triggered to drive the half-wall needle into the subcutaneous tissue, and the sensor The electrode detection part enters the subcutaneous tissue through the half-wall needle, and then exits the half-wall needle and leaves the electrode detection part in the subcutaneous tissue.
The implantation method according to claim 17, wherein when the needle aid is rotated to the release end of the rotation port of the housing, the release button on the needle aid contacts the trigger bump to automatically trigger the elastic device Drive the half-wall needle into the subcutaneous tissue.
A monitoring system is characterized in that it includes:

The subcutaneous interventional sensor device as claimed in any one of claims 1 to 10; and

The display device is configured to communicate with the subcutaneous interventional sensor device in wired or wireless communication, and is used to receive the measured object detection signal data sent by the sensor device, and process, analyze and visually display the data.
A monitoring method, characterized in that it comprises:

Implanting the subcutaneous interventional sensor into the subcutaneous tissue using the implantation method as claimed in any one of claims 11 to 18;

The subcutaneous interventional sensor collects and receives the detection signal of the measured object in real time;

Transmitting the detected object detection signal data to the display device in a wired or wireless manner; and

The display device processes and analyzes the received data for visual display.