CN113456071A - Blood glucose detection and hormone infusion integrated device, preparation method and artificial pancreas - Google Patents
Blood glucose detection and hormone infusion integrated device, preparation method and artificial pancreas Download PDFInfo
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- CN113456071A CN113456071A CN202110905159.8A CN202110905159A CN113456071A CN 113456071 A CN113456071 A CN 113456071A CN 202110905159 A CN202110905159 A CN 202110905159A CN 113456071 A CN113456071 A CN 113456071A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
- A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
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- A—HUMAN NECESSITIES
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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Abstract
The invention relates to an artificial pancreas device, in particular to an integrated device for blood sugar detection and hormone infusion, a preparation method and an artificial pancreas. The integrated device for detecting blood sugar and infusing hormone comprises an infusion tube and a CGM sensor, wherein one or two channels are arranged inside the infusion tube; the CGM sensor is disposed on an outer side of the infusion tube. The integrated device for detecting blood sugar and infusing hormone integrates the infusion tube and the CGM sensor, so that the infusion tube and the sensor can be implanted simultaneously only by implanting once when a user wears the integrated device, the implantation times are reduced, the wound infection risk is reduced, the integrated device is more convenient to use, good in stability and high in reliability, and the receiving degree of a patient is improved.
Description
Technical Field
The invention relates to an artificial pancreas, in particular to an integrated device for blood sugar detection and hormone infusion, a preparation method and the artificial pancreas.
Background
Diabetes is a metabolic disease characterized by hyperglycemia, and long-term hyperglycemia is caused by insulin secretion defect or impaired physiological action of a patient, and researches show that the long-term hyperglycemia is easy to cause pathological changes of tissues or organs such as eyes, kidneys, hearts, blood vessels, nerves and the like. At present, about 5 hundred million diabetics are in the world, and the diabetics are in the first place in China, so that the reasonable control of the blood sugar level of the diabetics can effectively prevent the occurrence of complications.
The insulin injection with reasonable dose can effectively manage the blood sugar level, thereby effectively reducing the occurrence of complications. The artificial pancreas combines the insulin pump device with the continuous blood sugar monitoring device (CGM), namely after the blood sugar level of a patient is monitored by the blood sugar monitoring system (CGM), the insulin pump system infuses insulin or glucagon according to the blood sugar level of the patient in a programmed manner, thereby realizing the blood sugar management of the patient. However, the existing artificial pancreas products need to be implanted with an insulin pump infusion tube and a continuous blood glucose monitoring sensor respectively, which results in increased wound when a user uses the product, and at the same time, the risk of infection is increased, and the two times of implantation bring pain to the body of the patient and inconvenience to life, thereby reducing the compliance of the patient in use.
Disclosure of Invention
In order to solve the problems, the invention provides a blood glucose detection and hormone infusion integrated device which integrates an infusion tube and a CGM sensor together, can reduce implantation times and wound infection risk and has high stability, and the specific technical scheme is as follows:
the integrated device for detecting blood sugar and infusing hormone comprises an infusion tube and a CGM sensor, wherein one or two channels are arranged inside the infusion tube; the CGM sensor is disposed on an outer side of the infusion tube.
Preferably, the CGM sensor includes a working electrode, a reference electrode, and a counter electrode, the working electrode, the reference electrode, and the counter electrode are all disposed on the outer side surface of the infusion tube, and the working electrode, the reference electrode, and the counter electrode are all insulated from each other or do not contact each other.
Preferably, the working electrode, the reference electrode and the counter electrode are all arranged outside the infusion tube in parallel.
Further, the working electrode, the reference electrode and the counter electrode are arranged on the outer side surface of the infusion tube in an annular array mode, or the working electrode, the reference electrode and the counter electrode are wound on the outer side surface of the infusion tube in a spiral mode.
Preferably, the working electrode, the reference electrode and the counter electrode are stacked on the outer side surface of the infusion tube, and the working electrode, the reference electrode and the counter electrode are partially exposed.
Further, the reference electrode is made of silver and silver chloride in a mixed mode, wherein the ratio of the silver to the silver chloride is 2: 8.
Preferably, the working electrode is prepared by mixing the following materials in parts by mass: 50-99 parts of a conductive material; 0.05-2 parts of oxidase; 0.05-2 parts of a cross-linking agent; wherein the conductive material comprises one or more of carbon, graphite, platinum, gold or metal oxide.
Preferably, the length of the infusion tube is 6-15mm, and the outer diameter is 0.2-0.4 mm; the depth of the CGM sensor implanted under the skin is 3-6 mm.
Preferably, the device further comprises a biocompatible membrane layer, wherein the biocompatible membrane layer is wrapped on the outer surface of the infusion tube and the CGM sensor.
The preparation method of the integrated device for blood sugar detection and hormone infusion comprises the steps that an infusion tube is formed by extrusion, spraying or dip-coating; the CGM sensor is formed on the outer side surface of the infusion tube through silk-screen printing, ink-jet printing or sputtering.
An artificial pancreas comprising: the integrated device for blood sugar detection and hormone infusion; an insulin pump device connected to the infusion tube for pumping in insulin and/or glucagon; the blood glucose monitoring device is electrically connected with the CGM sensor and is used for detecting blood glucose; and
wear the device, insulin pump device and blood sugar monitoring devices all install wear in the device, insulin pump device still with blood sugar monitoring devices electric connection, blood sugar detects and hormone infusion integrated device is located wear the outside of device, wear the device and be used for wearing on the human body.
Preferably, the included angle between the blood sugar detection and hormone infusion integrated device and the wearing device (6) is 30-90 degrees.
Compared with the prior art, the invention has the following beneficial effects:
the integrated device for detecting blood sugar and infusing hormone integrates the infusion tube and the CGM sensor, so that the infusion tube and the sensor can be implanted simultaneously only by implanting once when a user wears the integrated device, the implantation times are reduced, the wound infection risk is reduced, the integrated device is more convenient to use, good in stability and high in reliability, and the receiving degree of a patient is improved.
Drawings
FIG. 1 is a cross-sectional view of an infusion tube;
FIG. 2 is a schematic illustration of a cross-section of a delivery tube;
FIG. 3 is a front view of a parallel arrangement of a working electrode, a reference electrode and a counter electrode;
FIG. 4 is a rear view of the parallel arrangement of the working electrode, reference electrode and counter electrode;
FIG. 5 is a schematic structural diagram of a helical arrangement of a working electrode, a reference electrode and a counter electrode;
FIG. 6 is a schematic structural view of a stacked arrangement of a working electrode, a reference electrode and a counter electrode;
FIG. 7 is a schematic view of a blood glucose monitoring sensor and hormone infusion integrated device with a biocompatible membrane layer;
FIG. 8 is a schematic diagram of the construction of the artificial pancreas system.
Detailed Description
The invention will now be further described with reference to the accompanying drawings.
Example one
As shown in fig. 1 to 4, the integrated device for blood glucose detection and hormone infusion comprises an infusion tube 1 and a CGM sensor, wherein one or two channels are arranged inside the infusion tube 1, and the channel is used for insulin output or glucagon infusion; when the two channels are arranged, the two channels are respectively used for insulin output and glucagon infusion to realize the infusion of double hormones; the CGM sensor is disposed on the outside surface of the infusion tube 1.
The inside of infusion pipe 1 is equipped with baffle 13, and baffle 13 divides the inside of infusion pipe 1 into first passageway 11 and second passageway 12, and wherein first passageway 11 is insulin output pipeline, and passageway 12 is glucagon output pipeline the next day.
The CGM sensor comprises a working electrode 2, a reference electrode 3 and a counter electrode 4, wherein the working electrode 2, the reference electrode 3 and the counter electrode 4 are all arranged on the outer side surface of an infusion tube 1, and the working electrode 2, the reference electrode 3 and the counter electrode 4 are all insulated or not contacted with each other.
The insulin pump system can deliver the medicine such as insulin or glucagon in the medicine cavity to the human body through the infusion tube 1 by the medicine driving part, and the two channels can not be used in a crossed way.
The length of the integrated blood glucose detecting and hormone infusion device can be individually designed into different lengths according to the thickness of the subcutaneous fat layer so as to ensure that the medicine delivered into the body can be quickly absorbed and diffused, for example, the integrated blood glucose detecting and hormone infusion device is 6-15mm long and 0.2-0.4mm in diameter.
The CGM sensor is implanted in subcutaneous tissue of a patient together with the integrated device for blood sugar detection and hormone infusion.
The CGM sensor comprises a working electrode 2, a reference electrode 3 and a counter electrode 4 which form a three-electrode system, and has certain requirements on the subcutaneous implantation depth of the sensor in order to realize the best effect, namely the best monitoring of the glucose concentration in tissue fluid by the sensor, and the subcutaneous implantation depth of the sensor is 3-6 mm.
The working electrode 2, the reference electrode 3 and the counter electrode 4 are arranged in an annular equidistant manner, i.e. in an annular array around the axis of the infusion tube 1. As shown in fig. 3 and 4, the working electrode 2, the reference electrode 3 and the counter electrode 4 are parallel to each other and arranged on the outer side surface of the infusion tube 1 at equal intervals along the axis of the infusion tube 1, and the width of each electrode is 0.15mm-0.3 mm.
The reference electrode 3 is prepared by mixing silver and silver chloride, wherein the ratio of the silver to the silver chloride is 2: 8; the ratio can have the best potential stability, thereby improving the accuracy of blood sugar monitoring.
The working electrode 2 is prepared by mixing the following materials in parts by mass: 50-99 parts of a conductive material; 0.05-2 parts of glucose oxidase; 0.05-2 parts of cross-linking agent glutaraldehyde; wherein the conductive material comprises one or more of carbon, graphite, platinum, gold or metal oxide. The working electrode 2 made of the above material can obtain a more stable signal, thereby improving stability.
The counter electrode 4 is made of one or more materials of carbon, graphite, platinum, gold and metal oxide.
The infusion tube 1 is preferably made of a material with certain chemical stability, which does not react with insulin, glucagon and other medicaments; meanwhile, considering that the integrated device for blood glucose detection and hormone infusion is implanted into the body, the infusion tube 1 should preferably use a material with good biocompatibility, such as parylene, PDMS, PI, PET, TPU, etc.; thirdly, because the infusion tube 1 needs to be integrated with the three electrodes of the biosensor, in order to ensure that the infusion tube and the sensor electrode are better integrated, the infusion tube is not integrated in a traditional pasting or binding mode, and materials with better adhesive force with the electrodes, such as PET and PI, are selected; the above integrated blood glucose monitoring and hormone infusion device uses non-unique materials.
The CGM sensor designed on the infusion tube 1 needs to select a material with good adhesive force with the infusion tube 1 and also needs to select a specific material to realize the sensing monitoring function, the working electrode 2 can be made of one or more materials of carbon, graphite, platinum, gold and metal oxide, and the electrode needs to use a material with good electrocatalytic hydrogen peroxide performance so as to obtain ideal signal intensity, and the preferred material is noble metal platinum. Reference electrode 3 may be made of any material that provides a stable potential, preferably a silver/silver chloride material. The counter electrode 4 can be made of one or more materials of carbon, graphite, platinum, gold and metal oxide, and the noble metal platinum is preferred.
Example two
This embodiment is different from the first embodiment in that the working electrode 2, the reference electrode 3, and the counter electrode 4 are spirally arranged as shown in fig. 5.
EXAMPLE III
The difference between this embodiment and the first embodiment is that, as shown in fig. 6, the working electrode 2, the reference electrode 3, and the counter electrode 4 are stacked on the outer side surface of the infusion tube 1, and the working electrode 2, the reference electrode 3, and the counter electrode 4 are partially exposed, and the present embodiment further includes an insulating layer 5, where the insulating layer 5 is located between two adjacent electrodes and used for insulating the adjacent working electrode 2, the reference electrode 3, or the counter electrode 4.
Example four
On the basis of any of the above embodiments, as shown in fig. 7, a biocompatible film layer 7 is further included, and the biocompatible film layer 7 is wrapped on the outer surface of the infusion tube 1 and the CGM sensor.
The biocompatible film layer is prepared by mixing one or more materials of polyethylene glycol, polyvinyl alcohol, zwitterionic polymer or polyurethane, can be formed on the surface of the integrated device for blood sugar detection and insulin infusion by dip coating and spray coating, and has a thickness of 10-20 um; the biocompatibility of the implant device can be improved, and the wound infection risk can be reduced.
EXAMPLE five
The preparation method of the integrated device for blood sugar detection and hormone infusion comprises the steps that an infusion tube 1 is formed by extrusion, spraying or dip-coating; the CGM sensor is formed on the outer side of the infusion tube 1 by screen printing, inkjet printing, or sputtering.
The infusion tube 1 may be formed by some conventional processes, such as heating the polymer for preparing the infusion tube 1 to a molten state and then forming the polymer by an extrusion process. The infusion tube 1 can also be realized by spraying and dip-coating processes, namely, the material for preparing the infusion tube 1 is dissolved in a specific solvent, and the infusion tube 1 is prepared by spraying or dip-coating and molding after the solvent is volatilized.
The three electrodes of the sensor can be realized on the infusion tube 1 through the processes of silk screen printing, ink-jet printing, sputtering and the like. The materials of the working electrode 2, the reference electrode 3 and the counter electrode 4 are prepared into slurry and filled into an ink-jet printer, the electrodes are printed on the specific positions of the infusion tube 1 through the printer, solvent volatilization is accelerated through heating or infrared light treatment, and the integrated blood sugar detection and hormone infusion integrated device is realized after the electrode materials are cured on the infusion tube 1.
EXAMPLE six
As shown in fig. 8, an artificial pancreas comprising: the blood sugar detection and hormone infusion integrated device, the insulin pump device, the blood sugar monitoring device and the wearing device 6; the insulin pump device is connected with the infusion tube 1 and is used for pumping insulin and/or glucagon; the blood sugar monitoring device is electrically connected with the CGM sensor and is used for detecting blood sugar; insulin pump device and blood glucose monitoring device all install in wearing device 6, insulin pump device still with blood glucose monitoring device electric connection, blood glucose detection and hormone infusion integrated device are located the outside of wearing device 6, wear device 6 and are used for wearing on the human body. The included angle between the blood sugar detection and hormone infusion integrated device and the wearing device 6 is 30-90 degrees.
The artificial pancreas comprises an insulin pump device and a blood sugar monitoring device, wherein the insulin pump device is an existing device, and the insulin pump device comprises a medicine cavity, a medicine driving part, a medicine pipeline, a circuit part and a system control part. The blood sugar monitoring device is an existing device and can continuously detect blood sugar, and the blood sugar monitoring device comprises a sensor, a circuit part and a system control part. The information transmission between the system control part in the insulin pump device and the system control part in the blood sugar monitoring device can be connected in a wired mode, so that wired communication is realized, and the reliability of communication is ensured.
Because the insulin pump infusion tube and the sensor are separated in the prior art, the blood glucose monitoring device monitors that the blood glucose level of a patient is sent to the user terminal in a wireless transmission mode, the user terminal performs certain arithmetic operation again, and then sends an instruction to the insulin pump system in a wireless transmission mode, and then the insulin pump system infuses insulin or glucagon to the patient according to the instruction programming, the artificial pancreas excessively depends on the stability of the system due to the mode of multiple wireless transmissions, namely, the system cannot work under the condition of relatively poor stability, particularly under the condition of strong external environment interference, for example, the situation that the user cannot work normally when taking specific transportation means such as high-speed rails, airplanes and the like and passing through an access control system often occurs. In the embodiment, the insulin pump device and the blood glucose monitoring device are integrated in the wearing device 6, and the information transmission between the system control part in the insulin pump device and the system control part in the blood glucose monitoring device can be realized in a wired mode instead of a wireless mode, so that the stability and the reliability of the whole system are improved.
The blood glucose monitoring sensor and the hormone infusion integrated device provided by the invention integrate the infusion tube and the CGM sensor together, construct a plurality of multi-layer sensing electrodes by taking the infusion tube as a substrate and adopting a precise process, really integrate the infusion tube and the CGM sensor into a whole, reduce the thickness and the volume, have excellent material compatibility, mechanical toughness and stability, modify a biocompatible material on the outer surface, and can be implanted into the infusion tube and the sensor simultaneously only by being implanted once when a user wears the blood glucose monitoring sensor and the hormone infusion integrated device, thereby reducing the implantation times, reducing the wound infection risk, improving the convenience, adjusting the insulin and the glucagon with double hormones to ensure that the blood glucose management of a patient is more effective, enhancing the stability and the reliability of the whole system and improving the receiving degree of the patient.
The technical principle of the present invention is described above in connection with specific embodiments. The description is made for the purpose of illustrating the principles of the invention and should not be construed in any way as limiting the scope of the invention. Based on the explanations herein, those skilled in the art will be able to conceive of other embodiments of the present invention without inventive step, which shall fall within the scope of the appended claims.
Claims (12)
1. The integrated device for detecting blood sugar and infusing hormone is characterized by comprising an infusion tube (1) and a CGM sensor, wherein one or two channels are arranged inside the infusion tube (1); the CGM sensor is arranged on the outer side surface of the infusion tube (1).
2. The integrated device for blood glucose detection and hormone infusion according to claim 1, wherein the CGM sensor comprises a working electrode (2), a reference electrode (3) and a counter electrode (4), the working electrode (2), the reference electrode (3) and the counter electrode (4) are all arranged on the outer side surface of the infusion tube (1), and the working electrode (2), the reference electrode (3) and the counter electrode (4) are all insulated from each other or not in contact with each other.
3. The integrated device for blood glucose detection and hormone infusion according to claim 2, wherein the working electrode (2), the reference electrode (3) and the counter electrode (4) are all arranged in parallel outside the infusion tube (1).
4. The integrated device for blood glucose detection and hormone infusion according to claim 3, wherein the working electrode (2), the reference electrode (3) and the counter electrode (4) are arranged on the outer side surface of the infusion tube (1) in an annular array, or the working electrode (2), the reference electrode (3) and the counter electrode (4) are all spirally wound on the outer side surface of the infusion tube (1).
5. The integrated device for detecting blood sugar and infusing hormones into the body according to claim 2, wherein the working electrode (2), the reference electrode (3) and the counter electrode (4) are stacked on the outer side surface of the infusion tube (1), and the working electrode (2), the reference electrode (3) and the counter electrode (4) are partially exposed, and the integrated device further comprises an insulating layer (5), wherein the insulating layer (5) is positioned between two adjacent electrodes and used for insulating the adjacent working electrode (2), the reference electrode (3) or the counter electrode (4).
6. The integrated blood glucose detecting and hormone infusion device of claim 2, wherein the reference electrode (3) is made of silver and silver chloride mixed together, wherein the ratio of silver to silver chloride is 2: 8.
7. The integrated device for blood glucose detection and hormone infusion according to claim 2, wherein the working electrode (2) is made by mixing the following materials in parts by mass: 50-99 parts of a conductive material; 0.05-2 parts of oxidase; 0.05-2 parts of a cross-linking agent; wherein the conductive material comprises one or more of carbon, graphite, platinum, gold or metal oxide.
8. The integrated blood glucose detecting and hormone infusion device of claim 1,
the length of the infusion tube (1) is 6-15mm, and the outer diameter is 0.2-0.4 mm; the depth of the CGM sensor implanted under the skin is 3-6 mm.
9. The integrated blood glucose monitoring sensor and hormone infusion device of any one of claims 1 to 8, further comprising a biocompatible membrane layer (7), wherein the biocompatible membrane layer (7) is wrapped on the outer surface of the infusion tube (1) and CGM sensor.
10. The preparation method of the blood sugar monitoring sensor and the hormone infusion integrated device is characterized in that the infusion tube (1) is formed by extrusion, spraying or dip coating;
the CGM sensor is formed on the outer side surface of the infusion tube (1) through silk-screen printing, ink-jet printing or sputtering.
11. An artificial pancreas, comprising:
the integrated blood glucose monitoring sensor and hormone infusion device of claim 1;
an insulin pump device connected to the infusion tube (1) for pumping in insulin and/or glucagon;
the blood glucose monitoring device is electrically connected with the CGM sensor and is used for monitoring blood glucose; and
the insulin pump device and the blood glucose monitoring device are both arranged in the wearing device (6), and the insulin pump device is also electrically connected with the blood glucose monitoring device, so that data interaction is facilitated; the blood glucose monitoring sensor and hormone infusion integrated device is positioned outside the wearing device (6), and the wearing device (6) is worn on the human body.
12. The artificial pancreas according to claim 11, wherein the angle between the integrated blood glucose monitoring sensor and hormone infusion device and the wearing device (6) is 30-90 °.
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| WO2023071012A1 (en) * | 2021-10-25 | 2023-05-04 | Medtrum Technologies Inc. | Fully closed-loop artificial pancreas drug infusion control system |
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