CN108056778B - Biosensor electrode elastic implant device and method of use thereof - Google Patents

Abstract

A biosensor electrode elastic implantation device and method thereof, comprising: a housing (10), a hollow guide needle axially arranged in the housing (10) and fixed to a positioning seat (1), a hollow puncture needle (3) fixed to a puncture needle seat (4) and coaxially sleeved in the hollow guide needle (2) for smooth movement, a biosensor installed in the front end of the hollow puncture needle and moving with the puncture needle, a push needle (5) arranged behind the puncture needle seat (4), fixed on a push needle tube (6), inserted into the hollow puncture needle and coaxial with the hollow puncture needle, a push needle tube cover (7) arranged at the rear end of the push needle tube (6), and the end of the biosensor located in the hollow puncture needle forms a 10-15 degree angle. The present invention adopts a puncture combination sleeve, an elastic mechanism and a specific force-bearing structure to realize automatic puncture, and is a new type of sensor implantation device that is convenient for recovery, so that the usability and safety of the product are greatly improved.

Description

Biosensor electrode elastic implant device and method of use thereof

Technical Field

The present invention relates to a biosensor and a method for using the same, and in particular to an elastic implantation device for implanting a biosensor electrode subcutaneously and a method for using the same, wherein the biosensor electrode is a disposable capillary biosensor needle or wire.

Background Art

Some physiological diseases have a long course and are not cured. They require long-term and real-time monitoring of physiological parameters for better tracking and management. For example, diabetes requires real-time monitoring of blood sugar. Currently, the most commonly used blood glucose meter for diabetic patients is the finger blood glucose meter. Patients need to collect blood from their fingertips to measure the blood sugar level at that time. However, the defect of this point-in-time data is that it is impossible to know the changes in blood sugar levels between two measurements, and it is even more impossible to obtain the patient's blood sugar level during sleep (hypoglycemia and huge fluctuations in blood sugar often occur during sleep), which causes great trouble to diabetic patients. In order to solve these problems, a method that can provide continuous blood sugar monitoring is needed, so that patients can know their blood sugar status at any time, and take timely measures when they find the law of blood sugar changes, so as to most effectively control the disease, prevent complications, and obtain a higher quality of life.

The continuous blood glucose meter uses a sensor electrode that penetrates the subcutaneous tissue. When the patient's interstitial fluid undergoes an oxidation reaction with glucose in the body, an electrical signal is generated. The electrical signal is then converted into a blood glucose reading. The blood glucose reading is transmitted to a wireless receiver via a transmitter every 1-5 minutes, and a graph is formed to display the relevant blood glucose data for reference by patients and doctors.

At present, subcutaneously implanted glucose current sensors usually use very thin metal wires or polymer sheets as carriers. The metal wires can be stainless steel wires coated with platinum. For example, existing literature discloses the use of stainless steel wires with a diameter of 0.16-0.25 mm electroplated with platinum as carriers of sensor electrodes.

Since the stainless steel wire is hard enough, the sensor electrode can penetrate the skin and enter the tissue without the help of auxiliary tools. However, due to the large size and hardness of the sensor electrode, this implantation method causes a large wound, strong pain, and a strong sense of presence or strangeness after implantation under the skin, so the test subjects are not willing to accept it. At the same time, manual implantation has inconsistencies in each implantation action, and the increase in uncertainty factors leads to an increase in sensor deviation value.

In addition, when the metal wire carrier uses a relatively soft platinum wire or platinum-coated nickel wire, or a polymer sheet as a carrier, the carrier is not rigid enough to directly puncture the skin. The sensor electrode involved in the need to be implanted into the subcutaneous tissue with the help of auxiliary tools uses a fine platinum wire as a carrier to reduce the sense of presence or strangeness after implantation.

To this end, this field requires that tiny, soft biosensor electrodes be implanted subcutaneously. The puncture tube is inserted into the subcutaneous tissue at an extremely fast speed to minimize the pain and leave the sensor electrode subcutaneously. The implantation action is performed in the set channel, reducing the risk of deviation caused by manual operation.

Summary of the invention

In order to solve the above problems, the purpose of the present invention is to provide an elastic implant device for implanting a biosensor under the skin of a human body and a method for using the same. The elastic implant device for implanting a biosensor under the skin of a human body and a method for using the same solve the problem that small and soft biosensors are difficult to implant under the skin, while reducing the area of trauma, alleviating the pain of puncturing subcutaneous tissue, and reducing the risk of deviation caused by manual operation.

In addition, another purpose of the elastic implant device for assisting sensor electrode puncture of the present invention is to solve the connection method between the sensor electrode to be implanted and the external electronic connection circuit. Due to its small and soft characteristics, it is not possible to effectively connect the sensor electrode to the electrical signal converter or transmitter by conventional methods such as welding, because welding will generate high temperature and cause the biological on the sensor electrode to lose activity, causing the sensor electrode performance to be distorted or invalid.

In order to achieve effective connection with the electrical signal converter or transmitter without affecting its performance, the electrical signal transmission of the sensor electrode to be implanted in the present invention uses conductive rubber as the transmission medium of the electrical signal. The sensor electrode needs to pass through the conductive rubber and be tightly combined with the conductive rubber. There is no need to apply destructive actions or measures to the sensor electrode, thereby effectively protecting the effectiveness of the sensor electrode.

According to the present invention, the sensor electrode to be implanted is separated by a plurality of electrodes through an insulating layer through a soft platinum wire carrier, so as to include at least one working electrode and one reference electrode. The platinum wire carrier has a diameter of 0.12 mm, is extremely small and soft, and does not have the ability to penetrate the skin. The sensor electrode is designed with a sensing area for glucose in subcutaneous tissue fluid. The sensor electrode is used to detect that the analyte is glucose in subcutaneous tissue fluid, and its sensing area is required to be implanted in the subcutaneous tissue. Therefore, the sensing area is required not to stay in the dermis, nor to be implanted in the muscle.

The sensing area of the sensor electrode is covered with a layer of polymer material that reacts chemically with the glucose in the subcutaneous tissue fluid being analyzed, and generates an original electrical signal that can be detected by electronic components, which is transmitted to the electrical signal converter or transmitter through the conductive medium for signal recognition and conversion, and then sent to the receiver or the corresponding APP for medical professionals or patients to read. The sensor electrode uses conductive rubber as the transmission medium. The working electrode and the reference electrode of the sensor electrode need to be tightly combined with the conductive rubber to form a good contact, and they are insulated from each other and not conductive. The sensor electrode that needs to be implanted is usually worn on the arms, belly, thighs and other parts. It is inevitable to contact with water during continuous wearing. When in contact with water, it is necessary to prevent the working electrode and the reference electrode from forming a loop through water conduction, causing the sensor electrode to fail.

In order to achieve the above-mentioned object, the technical scheme of the elastic implantation device of the biosensor electrode of the present invention is as follows:

A biosensor electrode elastic implant device, comprising:

Housing 10,

When in use, the positioning seat 1 combined with the sensor base 101,

A hollow guide needle 2 is axially arranged in the housing 10 and fixed to the positioning seat 1.

A handle is provided for pushing the hollow puncture needle to move in the hollow guide needle, and

The hollow puncture needle 3 is fixed to the puncture needle seat 4, sleeved in the hollow guide needle 2 with clearance fit, and moves smoothly.

It is characterized in that

The sensor base 101 is provided with a rotating base 102 which can be tilted and rotated up and down.

The rotating seat is provided with a silicone seat 103 for passing the hollow guide needle 2 and having a conductive rubber 104 built therein.

The biosensor electrode 105 is installed in the front end of the hollow puncture needle and moves with the hollow puncture needle.

The push needle 5 is located behind the puncture needle seat 4 and is arranged on the push needle tube 6.

The push needle 5 is inserted into the hollow puncture needle to push the biosensor electrode 105 in the hollow puncture needle forward.

A spring 9 is provided on the outer sleeve of the connecting rod 8 between the push needle tube 6 and the puncture needle seat 4 .

According to the present invention, the silicone seat is used to install the conductive rubber and provide waterproof protection for the conductive rubber. When the guide needle passes through the silicone seat and the conductive rubber mounted on the silicone seat, the silicone seat and the conductive rubber are expanded, squeezed and deformed. When the sensor electrode is implanted and the electrical signal converter or transmitter is installed, pressure is applied to the silicone seat at the same time to obtain a closed space for the conductive rubber, thereby achieving waterproofing of the conductive rubber.

According to the present invention, a biosensor electrode elastic implant device is characterized in that:

The sensor electrode is located 2 to 3 mm from the end of the hollow puncture needle, i.e., at the rear end of the hollow puncture needle, and forms a bend of 10 to 15 degrees relative to the axial direction of the hollow puncture needle, so that when the biosensor is placed in the hollow puncture needle, this bent portion generates a friction force with the inner wall of the hollow puncture needle, thereby keeping the biosensor in the hollow puncture needle without slipping when not pushed by force.

According to the elastic implant device of a biosensor electrode of the present invention, the feature is that an assembly blind hole 1031 for installing the conductive rubber 104 is provided on the upper side of the silicone seat 103, and an energy release blind hole 1032 for releasing the deformation energy of the conductive rubber 104 is provided on the lower side of the silicone seat 103.

According to the present invention, the conductive rubber is elastically deformably embedded in the assembly blind hole in a columnar or block shape.

Since the conductive properties of the conductive rubber are determined by the data of the conductive particles per unit size of the conductive rubber, when the conductive rubber is deformed, its conductive properties change, causing the original electrical signal implanted by the sensor electrode to deviate and become distorted. In order to obtain a true and reliable electrical signal, the conductive rubber is provided with holes that release deformation energy to make the deformation of the conductive rubber controllable.

According to the elastic implant device of a biosensor electrode of the present invention, preferably, after the puncture needle exits the silicone seat, the silicone seat rotates with the rotating seat and fits parallel to the bottom surface of the sensor base, so that the sensor and/or transmitter are built in it.

According to the elastic implant device of a biosensor electrode described in the present invention, it is characterized in that an axle pin 1021 is provided at the bottom of the rotating seat 102, and a pair of corresponding rotating shaft snap-fits 1014 are provided inside the sensor base. The axle pin 1021 at the bottom of the rotating seat is inserted into a pair of corresponding rotating shaft snap-fits 1014 of the sensor base, so that the rotating seat can be assembled on the sensor base so as to be tilted and rotated up and down.

According to the elastic implant device of a biosensor electrode described in the present invention, it is characterized in that a deformable notch 1023 is provided in the middle of the axle pin 1021 at the bottom of the rotating seat. When the axle pins on both sides of the rotating seat are inserted into a pair of corresponding rotating shaft snap-fits of the sensor base, the positions of the axle pins on both sides of the rotating seat will be squeezed and deformed toward the center of the rotating seat. The setting of the deformation notch 1023 can release the pressure of the squeezing deformation, so that the axle pin 1021 of the rotating seat can be smoothly inserted into the rotating shaft snap-fit 1014 inside the sensor base.

According to the elastic implantation device for biosensor electrodes of the present invention, the feature is that the upper end of the rotating seat 103 is provided with a positioning hole for guiding the hollow guide needle 2 to accurately pass through the silicone seat 103.

The sensor base 101 is provided with a positioning key 1012 for positioning the bottom plate of the positioning base 1 and an elastic buckle 1013 for elastically clamping and locking the bottom plate of the positioning base, so as to facilitate removal after use.

When fixing the shell 10 on the sensor base 101, the shell is inserted into the positioning tube of the positioning seat 1, and the positioning port of the positioning seat is inserted into the positioning key 1012 of the sensor base to position the positioning seat 1, and then the positioning seat bottom plate is inserted into the sensor base 101 through the elastic buckle 1013 provided on the sensor base to form an elastic fixed connection.

According to the present invention, a positioning hole is provided at the upper end of the rotating seat to guide the guide needle to accurately pass through the silicone seat. The rotating seat is also provided with a concave (card) groove for installing the silicone seat, and the silicone seat is elastically inserted into the concave (card) groove and pressed against the rotating seat at the same time.

According to the elastic implant device of a biosensor electrode of the present invention, the feature is that the part of the puncture needle seat extending out of the shell is provided with two handles 402, and the handles can be movably inserted into the guide grooves (1002) of the shell.

The upper end and the middle of the guide groove are respectively provided with limit snap-in openings (1004) for moving the handle therein for positioning.

The puncture needle seat moves downward under the elastic force of the spring, and moves upward when the handle is manually pulled upward.

According to the present invention, a biosensor electrode elastic implant device is characterized in that:

A connecting rod 8 is also provided in the housing 10.

One end of the connecting rod 8 is inserted into the lower end surface of the push needle tube 6, and the other end is fixed to the puncture needle seat 4, so that the puncture needle seat 4 and the push needle tube 6 form a movable connection.

The puncture needle seat 4 and the needle push tube 6 are respectively provided with two semicircular bayonet holes for plugging the connecting rod 8, and the connecting rod is a combination of two semicircular connecting rods with two cross sections.

According to the present invention, the lower end of the connecting rod is fixed to the puncture needle seat, and the upper end is inserted into the semicircular bayonet on the lower end surface of the push needle tube. The upper end of the connecting rod and the semicircular bayonet on the lower end surface of the push needle tube are gap-matched. The connecting rod slides in the semicircular bayonet on the lower end surface of the push needle tube, and the puncture needle seat and the push needle tube form a movable connection.

The puncture needle seat is provided with a spring locking boss 601, that is, an annular protrusion, so that a spring is provided on the outer sleeve of the connecting rod.

According to the elastic implant device of a biosensor electrode of the present invention, it is characterized in that the sensor base 101 is bonded with a non-woven fabric tape by ultrasonic welding or adhesive, and a ventilation hole 1011 is provided on the bottom surface of the sensor base.

Therefore, the sensor base is kept attached to the skin for many consecutive days through non-woven tape but not limited to non-woven tape. The bottom surface of the sensor base is provided with ventilation holes to allow the skin attached to the sensor base to breathe, thereby reducing skin allergies or other discomforts caused by airtightness.

According to the elastic implantation device for biosensor electrodes of the present invention, preferably,

Two guide bars (201) are correspondingly arranged on the outer circumference of the push pin tube for guiding the push pin tube to move up and down along the inner wall of the shell. The guide bars pass through the guide bar through holes and guide notches (202) on the top surface of the shell, so that the push pin tube and the shell form a smooth moving arrangement.

According to the elastic implantation device for biosensor electrodes of the present invention, preferably,

The hollow guide needle tube has an inner diameter of 0.5 and an outer diameter of 0.6. The inner and outer diameters of the needle tube are not limited, and a suitable diameter can be selected according to the inserted hollow puncture needle. The hollow guide needle and the hollow puncture needle are clearance-matched.

According to the present invention, the surface of the sensor electrode to be implanted is covered with a polymer film layer, which reacts with the analyzed tissue to form an electrical signal when implanted in the subcutaneous tissue. The wear of the film layer may increase the deviation value of the electrical signal of the sensor electrode. The sensor electrode is placed in a hollow puncture needle tube to form a limited fit with the empty puncture needle tube, thereby reducing the wear of the sensor electrode during the puncture movement.

According to the present invention, preferably, the hollow guide needle is made of stainless steel with smooth inner and outer surfaces, but is not limited to stainless steel, and may be other hard metal materials.

According to the present invention, preferably, the hollow puncture needle tube has an inner diameter of 0.35 and an outer diameter of 0.45.

According to the present invention, preferably, the push needle uses a needle rod with an outer diameter of 0.3 mm, but is not limited to 0.3 mm. It can be selected from a puncture needle tube.

According to the present invention, preferably, the hollow guide needle is fixed inside the positioning seat, and the hollow guide needle forms an angle of 35-45 degrees with the bottom surface of the positioning seat.

This angle allows the puncture needle to penetrate the skin tissue more easily, reduces the patient's pain and damage to the tissue, and improves the success rate of puncture.

According to the elastic implant device for a biosensor electrode of the present invention, preferably, a locking boss (601) is provided at the lower part of the push needle tube, i.e., an inner ring of an annular protrusion, for limiting the position of the push needle tube, and the limiting position is determined according to the biosensor to be pushed into the skin.

According to the elastic implant device of a biosensor electrode described in the present invention, preferably, the push needle tube is above the puncture needle seat, connected to the puncture needle seat through a connecting rod, and assembled on the outer shell. A semicircular bayonet for connecting the connecting rod is provided at the lower end of the push needle tube, and a buckle is provided on the top surface of the push needle tube. The push needle tube passes through the top surface of the outer shell and is combined with the push needle tube cover. The bayonet pin provided on the push needle tube cover is inserted into the buckle of the push needle tube and fixedly connected to the push needle tube.

According to the elastic implantation device for biosensor electrodes of the present invention, preferably,

The portion of the puncture needle holder extending out of the housing is provided with two handles 402, which can be movably inserted into the guide grooves (1002) of the housing.

The upper end and the middle of the guide groove are respectively provided with limit snap-in openings (1004) for moving the handle therein for positioning.

The puncture needle seat moves downward under the elastic force of the spring, and moves upward when the handle is manually pulled upward.

According to the present invention, the guide groove of the puncture needle seat can be inserted into the limiting snap-in, and in the absence of external force, the limiting snap-in will keep the guide groove of the puncture needle seat in the limiting snap-in and prevent it from slipping off.

According to the present invention, the handle of the puncture needle seat is pulled to move the puncture needle seat toward the top surface of the shell, and the guide groove of the puncture needle seat is then inserted into the limit snap-in of the shell when the guide groove of the shell runs to the top, compressing the spring to generate elastic force and store it, and when the guide groove of the puncture needle seat is separated from the limit snap-in of the shell, the compressed spring releases the elastic force to push the puncture needle seat downward.

According to the elastic implantation device for biosensor electrodes of the present invention, the feature is that the puncture needle is arranged in the hollow guide needle 2 so that the bevel of the puncture needle tip faces upward when the puncture needle is in use.

The present invention further provides a method for elastically implanting a biosensor electrode, which is characterized in that, using the elastic implantation device for the biosensor electrode, the sensor electrode to be implanted is placed in a hollow puncture needle, and punctured through the conductive rubber and its components together with the puncture needle for use, and then the puncture needle is withdrawn from the conductive rubber. At the same time, under the action of the push needle, the sensing area end of the sensor electrode is retained in the area to be tested, and the other end is retained in the conductive rubber.

According to the elastic implantation method of a sensor electrode described in the present invention, it is characterized in that the conductive rubber is installed on the silicone seat, and a compressive force is applied to the silicone seat through the electrical signal converter or the transmitter. The deformable elasticity of the silicone itself makes the silicone seat and the conductive fitting surface of the electrical signal converter or the transmitter fit tightly to form a sealed space, thereby preventing water from contacting the conductive rubber.

According to the present invention, the puncture needle is arranged in the hollow guide needle 2 so that when the puncture needle is in use, the bevel of the puncture needle tip faces upward.

The biosensor is a needle-shaped or wire-shaped metal biosensor. Preferably, the hollow guide needle is made of stainless steel with smooth interior and exterior, so that the puncture needle is inside the hollow guide needle.

Preferably, the hollow guide needle forms an angle of 40 degrees with the bottom surface of the positioning seat.

As a result, the puncture needle can more easily penetrate the skin tissue, reduce the patient's pain and damage to the tissue, and improve the success rate of puncture.

In addition, while the hollow guide needle is clamped in the biosensor base, it passes through the silicone seat and conductive rubber of the biosensor, avoiding contact between the puncture needle and the silicone seat and conductive rubber of the biosensor, and avoiding the risk of the puncture needle bringing silicone and conductive rubber into the subcutaneous tissue during puncture.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A and FIG. 1B are schematic three-dimensional views of the structure of the elastic implant device of the present invention.

FIG. 2 is an exploded schematic diagram of the parts of the elastic implant device of the present invention.

3 and 4 are schematic diagrams of the puncture needle seat of the elastic implant device of the present invention.

5 and 6 are schematic diagrams of the push-pin tube of the elastic implant biosensor of the present invention.

FIG. 7 is a schematic diagram of a push-pin tube cover of a biosensor of the elastic implant device of the present invention.

8 and 9 are schematic diagrams of the biosensor base of the elastic implant device of the present invention.

10 and 11 are schematic diagrams of the silicone seat of the elastic implant device of the present invention.

12 and 13 are schematic diagrams of the bottom of the biosensor base of the elastic implant device of the present invention and the dismantled rotating seat.

14 and 15 are schematic diagrams of the rotating seat of the elastic implant device of the present invention.

FIG. 16 is a schematic cross-sectional view of a silicone seat.

In the figure: 1 is a positioning seat, 2 is a hollow guide needle, 3 is a hollow puncture needle, 4 is a puncture needle seat, 5 is a push needle, 6 is a push needle tube, 7 is a push needle tube cover, 8 is a connecting rod, 9 is a spring, 10 is a housing, and 101 is a sensor base.

201 is a raised guide strip correspondingly arranged on the outer peripheral side of the push needle tube, and the guide strip can be a partial or intermittent protrusion, 202 is a guide slot, 1002 is a guide slot penetratingly arranged on the shell wall, used for the handle to drive the puncture needle to move up and down along the shell wall, 1004 is a limit snap-in arranged at the upper end and middle part of the guide slot, used for positioning the handle, 601 is a positioning boss (limiting ring) at the lower part of the push needle tube, 1001 is a positioning and fixing buckle arranged on the outer periphery of the bottom of the shell, 401 is a spring positioning boss arranged on the upper end of the puncture needle seat, 402 is a handle, and 403 is a semicircular snap-in for the puncture needle seat to connect the connecting rod. 603 is a semicircular snap-in for the push needle tube to connect the connecting rod.

In the figure: 1011 air vent, 1012 positioning key, 1013 elastic buckle, 1014 shaft bayonet, 102 rotating seat, 1021 shaft pin, 1022 positioning hole, 1023 deformation notch, 1024 positioning hole, 103 silicone seat, 1031 assembly blind hole, 1032 energy release blind hole, 104 conductive rubber, 105 sensor electrode, 2001, 2002 are respectively positioning protrusions that cooperate with the positioning key 1012 and the buckle 1001, 2003 positioning tube, 602 guide key, 801 limit ring, 803 buckle, 901 is a bayonet pin that cooperates with the buckle 803.

DETAILED DESCRIPTION

Example

Referring to FIG1 , a biosensor electrode elastic implant device comprises:

The housing 10, when in use, has a positioning seat 1 combined with the sensor base 101, a hollow guide needle 2 axially arranged in the housing 10 and fixed to the positioning seat 1, a handle for pushing the hollow puncture needle to move in the hollow guide needle, and a hollow puncture needle 3 fixed to the puncture needle seat 4, sleeved in the hollow guide needle 2 with a clearance fit, and moving smoothly.

The sensor base 101 is provided with a rotating base 102 that can be tilted and rotated up and down, and a silicone base 103 with a conductive rubber 104 built in is provided on the rotating base for passing through the hollow guide needle 2, and a biosensor electrode 105 is installed at the front end of the hollow puncture needle, and moves with the hollow puncture needle, and a push needle 5 is located behind the puncture needle base 4 and is provided on the push needle tube 6. The push needle 5 is inserted into the hollow puncture needle and is used to push the biosensor electrode 105 in the hollow puncture needle forward, and a spring 9 is provided on the outer sleeve of the connecting rod 8. The sensor base 101 is bonded with a non-woven fabric tape by ultrasonic welding or adhesive, and a vent hole 1011 is provided on the bottom surface of the sensor base.

The front end of the positioning seat bottom plate is inserted into the sensor base, and the rear end is pressed into the sensor base. The deformable snap-in on the sensor base locks the positioning seat bottom plate. At the same time, the hollow guide needle fixed inside the positioning seat passes through the biosensor mounting silicone seat and conductive rubber, and the angle with the bottom surface is 40 degrees.

According to this embodiment, an axle pin 1021 is provided at the bottom of the rotating seat 102, and a pair of corresponding rotating shaft snap-fits 1014 are provided inside the sensor base. The axle pin 1021 at the bottom of the rotating seat is inserted into a pair of corresponding rotating shaft snap-fits 1014 of the sensor base, so that the rotating seat can be assembled on the sensor base so as to be tilted and rotated up and down.

According to this embodiment, a deformable notch 1023 is provided in the middle of the axle pin 1021 at the bottom of the rotating seat. When the axle pins on both sides of the rotating seat are inserted into a pair of corresponding rotating shaft snap-fits of the sensor base, the positions of the axle pins on both sides of the rotating seat will be squeezed and deformed toward the center of the rotating seat. The setting of the deformable notch 1023 can release the pressure of the squeezing deformation, so that the axle pin 1021 of the rotating seat can be smoothly inserted into the rotating shaft snap-fit 1014 inside the sensor base.

See Figure 1 (4) puncture needle holder, provided with a handle, a spring-engaging boss, and a semicircular bayonet, (8) one end of the connecting rod is inserted into the semicircular bayonet 403 of the (4) puncture needle holder, (8) the other end of the connecting rod is inserted into the semicircular bayonet 603 of the push needle tube, and the puncture needle holder and the push needle tube are movably connected, (6) the push needle tube is movably connected to the puncture needle holder through the connecting rod, and the push needle of the push needle tube is inserted into the hollow puncture needle, (9) the spring is placed in (10) One end of the shell is pushed against the inner top surface of the shell, and the (4) puncture needle seat and (6) push needle tube are installed into the shell. The handle of the puncture needle seat is inserted into the positioning groove of the shell, and the spring positioning boss is inserted into the spring. The puncture needle seat is compressed and then inserted into the upper bayonet of the shell. At the same time, the upper end of the (6) push needle tube passes through the through hole on the top surface of the shell, and the guide strips on both sides of the push needle tube pass through the notch on the top surface of the shell, and then the (7) push needle tube cover is inserted into the (6) push needle tube for fixed connection. The biosensor is installed in the hollow puncture needle, and the buckle at the lower end of the shell is inserted into the slot of the positioning seat to form a fixed connection.

See Figure 1. When the biosensor needs to be implanted in the subcutaneous tissue, twist the handle on the puncture needle seat (4), and the puncture needle seat will come out of the upper snap-in slot of the shell and enter the guide groove of the shell. Under the tension of the (9) spring, the puncture needle, puncture needle seat, push needle, and push needle tube move quickly together, and the puncture needle quickly punctures the subcutaneous tissue to minimize the pain. When the puncture needle is pulled out, the thumb presses the push needle tube cover, and the index and middle fingers pull the handle of the puncture needle seat upward until it is stuck in the lower snap-in slot of the shell. The puncture needle is lifted up, and the push needle is pressed by the thumb. The push needle prevents the biosensor from moving upward with the puncture needle, thereby implanting it subcutaneously.

According to this embodiment, the silicone seat is used to install the conductive rubber and provide waterproof protection for the conductive rubber. When the guide needle passes through the silicone seat and the conductive rubber mounted on the silicone seat, the silicone seat and the conductive rubber are expanded, squeezed and deformed. When the sensor electrode is implanted and the electrical signal converter or transmitter is installed, pressure is applied to the silicone seat at the same time to obtain a closed space for the conductive rubber, thereby achieving waterproofing of the conductive rubber.

According to this embodiment, the sensor electrode is formed at the end 3mm of the hollow puncture needle, that is, the rear end of the hollow puncture needle forms a bend of 13-15 degrees relative to the axial direction of the hollow puncture needle, so that when the biosensor is placed in the hollow puncture needle, this bend generates a friction force with the inner wall of the hollow puncture needle, so that the biosensor remains in the hollow puncture needle without slipping when not pushed by force. The hollow puncture needle tube adopts a stainless steel needle tube with an inner diameter of 0.35 and an outer diameter of 0.45, and the push needle uses a needle rod with an outer diameter of 0.3mm. The arrangement of the puncture needle in the hollow guide needle 2 makes the puncture needle tip bevel face upward when the puncture needle is in use, and the hollow guide needle forms an angle of 40 degrees with the bottom surface of the positioning seat.

After the puncture needle exits the silicone seat, the silicone seat rotates along with the rotating seat and fits parallel to the bottom surface of the sensor base, so that the sensor and/or the transmitter are buried therein.

A biosensor electrode elastic implantation device and method according to the present invention solves the problem that small and soft biosensors are difficult to implant subcutaneously, reduces the area of trauma, alleviates the pain of puncturing subcutaneous tissue, and reduces the risk of deviation caused by manual operation.

Claims (9)

1. A biosensor electrode spring implant device, comprising:

A housing (10),

When in use, the positioning seat (1) combined with the sensor base (101),

A hollow guide needle (2) axially arranged in the shell (10) and fixed on the positioning seat (1),

A handle for pushing the hollow puncture needle to move in the hollow guide needle is arranged, and

A hollow puncture needle (3) fixed on the puncture needle seat (4) and sleeved in the hollow guide needle (2) in clearance fit and capable of smoothly moving,

It is characterized in that the method comprises the steps of,

The sensor base (101) is provided with a rotating seat (102) which can be rotated in an up-down tilting way,

The rotating seat is provided with a silica gel seat (103) which is used for penetrating through the hollow guide needle (2) and is internally provided with conductive rubber (104),

The biosensor electrode (105) is arranged at the front end in the hollow puncture needle and moves along with the hollow puncture needle,

A push needle (5) which is positioned behind the puncture needle seat (4) and is arranged on the push needle tube (6),

The push needle (5) is inserted into the hollow puncture needle and used for pushing the biosensor electrode (105) in the hollow puncture needle to move forward,

The upper end of the connecting rod (8) is inserted into a semicircular bayonet of the lower end face of the push needle tube, is in clearance fit with the semicircular bayonet of the lower end face of the push needle tube, the other end of the connecting rod is fixed on the puncture needle seat (4), the upper end of the connecting rod can slide in the semicircular bayonet of the lower end face of the push needle tube, the puncture needle seat (4) and the push needle tube (6) form a movable connection,

The connecting rod (8) is sleeved with a spring (9), the spring is placed in the shell, one end of the spring is propped against the inner top surface of the shell, and the other end of the spring is inserted into a spring clamping boss of the puncture needle seat (4).

2. The elastic implantation device for a biosensor electrode according to claim 1, wherein the end of the sensor electrode (105) in the hollow puncture needle (3) is 2-3 mm, i.e. the rear end in the hollow puncture needle forms a bend which is 10-15 degrees relative to the axial direction of the hollow puncture needle, so that when the biosensor electrode (105) is placed in the hollow puncture needle, the bent part and the inner wall of the hollow puncture needle generate a friction force, and the biosensor electrode (105) is kept in the hollow puncture needle without slipping when not pushed by force.

3. The elastic implantation device for the biosensor electrode according to claim 1, wherein the upper side surface of the silica gel seat (103) is provided with an assembly blind hole (1031) for installing the conductive rubber (104), and the lower side surface of the silica gel seat (103) is provided with an energy release blind hole (1032) for releasing deformation energy of the conductive rubber (104).

4. The elastic implantation device for the biosensor electrode according to claim 1, wherein the bottom of the rotating base (102) is provided with a shaft pin (1021), the inside of the sensor base is provided with a corresponding shaft bayonet (1014), and the shaft pin (1021) at the bottom of the rotating base is clamped into the corresponding shaft bayonet (1014) of the sensor base, so that the rotating base can be assembled on the sensor base in an up-down tilting and rotating manner.

5. The elastic implantation device for the biosensor electrode according to claim 4, wherein a deformable notch (1023) is provided in the middle of the shaft pin (1021) at the bottom of the rotation seat, and when the shaft pins at the two sides of the rotation seat are clamped into the corresponding shaft bayonets of the sensor base, the positions of the shaft pins at the two sides of the rotation seat will generate extrusion deformation towards the center of the rotation seat, and the arrangement of the deformable notch (1023) can release the extrusion deformation pressure, so that the shaft pin (1021) of the rotation seat can be smoothly clamped into the shaft bayonets (1014) inside the sensor base.

6. The elastic implantation device of the biosensor electrode according to claim 1, wherein the upper end of the rotating seat (102) is provided with a positioning hole for guiding the hollow guide needle (2) to accurately pass through the silica gel seat (103),

The sensor base (101) is provided with a positioning key (1012) for positioning the bottom plate of the positioning seat (1) and an elastic buckle (1013) for elastically clamping and locking the bottom plate of the positioning seat, so that the sensor is convenient to pull out after use.

7. A biosensor electrode elastic implant device according to claim 1, wherein,

The part of the puncture needle stand extending out of the shell is provided with two handles (402) which are movably clamped into guide grooves (1002) of the shell,

A limiting bayonet (1004) for moving the handle into the guide groove to be positioned is respectively arranged at the upper end and the middle of the guide groove,

The puncture needle seat moves downwards under the action of the elasticity of the spring and moves upwards when the handle is pulled upwards manually.

8. A biosensor electrode elastic implant device according to claim 1, wherein,

A connecting rod (8) is also arranged in the shell (10),

The puncture needle seat (4) and the push needle tube (6) are respectively provided with two semicircular bayonets for being inserted with a connecting rod (8), and the connecting rod is a two-section semicircular connecting rod combination.

9. The elastic implantation device for the biosensor electrode according to claim 1, wherein the sensor base (101) is formed by bonding a non-woven fabric adhesive tape with ultrasonic welding or adhesive, and the bottom surface of the sensor base is provided with ventilation holes (1011).