Drug compliance management system

Drug compliance management system {Drug compliance management system}

The present invention relates to a drug compliance management system, and more particularly, to a system for managing drug compliance in relation to drug injection through a microneedle.

Recently, the importance of drug compliance is increasing. Drug adherence refers to how much a patient takes a prescribed amount on time as prescribed by a doctor.

In addition, the rate of not remembering whether or not the drug was administered during the administration period reaches 1/3 of all patients, and the case of forgetting to take the drug itself is up to 1/2 of the total patients.

According to a report by the American Pharmacists Association (APhA), drug non-compliance directly causes 125,000 deaths annually in the United States alone, and the cost of this

It is estimated to reach 360 trillion won annually.

In order to solve such a problem and increase drug compliance, many mobile phone applications for managing a patient's medication have been released. Representative applications include Medisafe and MyTherapy. Although the main function of these applications is to inform the patient so that he or she can administer the drug at a predetermined time, there is an inconvenience in that the patient has to input the drug to be administered and the time of administration by himself/herself. In addition, it is impossible for medical staff to monitor data such as a patient's medication history in real time or remotely.

Another way to increase drug compliance is an insulin pump, for example. Insulin pumps, such as Insulet Corporation's OMNIPOD, allow insulin to be injected continuously for several days or by the patient's manipulation while a needle is immersed in the patient's body.

As disclosed in US Patent No. 11,090,434, the insulin pump provides information on biometric information and drug injection amount measured by a sensor (eg, a continuous glucose monitor) to hospitals, health care companies, or services. can

Recently, a method of injecting drugs through a microneedle has been spotlighted. Most of the microneedles are manufactured in the form of attaching to the skin as an adhesive patch. In some cases, the microneedle of the drug is injected into the skin.

However, such patch-type and hollow microneedles are mainly used for one-time use, and there is a problem in that periodic or repeated injection is impossible. In order to solve this problem, the present applicant has disclosed a microneedle applicator and a cartridge capable of periodically injecting a drug using a microneedle through International Patent Publication No. WO 2021/167410.

However, in order to more efficiently operate a microneedle applicator capable of periodically or repeatedly injecting a drug, there is a need for a system or method capable of managing compliance with drug injection.

<p><patcit num="0001"><text>US 11,090,434 B, 2021.08.17.</text></patcit><patcit num="0002"><text>US 8,668,675 B, 2014.03.11.</text></patcit><patcit num="0003"><text>WO 2021/167410, 2021.08.26.</text></patcit></p>

<p>An object of the present invention is to provide a management system capable of periodically or repeatedly injecting a drug through a microneedle and managing drug compliance with drug injection.</p><p>Another object of the present invention is to enable drug registration and compliance management to be performed by medical staff.</p><p>Another object of the present invention is to record and store failure factors, etc., when injection or administration of a drug fails.</p><p>Another object of the present invention is to prevent infection of an invasive site according to repeated invasion of microneedles.</p>

<p>The drug compliance management system of the present invention devised to achieve the above object is equipped with a cartridge having a plurality of microneedle bases installed, and presses one of the microneedle bases to the skin side by a pressing unit, provided on the lower surface of the microneedle base The microneedle is invasive to the skin and the drug is injected, the cartridge is rotated to pressurize each microneedle base to the same skin location, and a warning is generated by vibration or sound before the microneedle is invaded, and the control unit fails to inject the drug A microneedle applicator in the form of a wearable device that detects and transmits the reason; a patient terminal for processing drug compliance information including the drug injection information delivered from the microneedle applicator, the dosage information separately administered and input by the patient, and the reason for the injection failure identified by the control unit of the microneedle applicator; a server transmitting the drug compliance information received from the patient terminal to the expert terminal; It consists of an expert terminal displaying the drug compliance information collected from a plurality of patient terminals.</p><p> delete</p><p> delete</p><p> delete</p><p> delete</p><p> delete</p><p> delete</p><p>It is also preferable that the number or arrangement of the microneedles on the lower surface of each microneedle base is formed differently.</p><p>The microneedle base is preferably provided to be movable up and down in a plurality of through-holes machined in the cartridge.</p><p>Preferably, the upper and lower surfaces of the through hole are sealed.</p><p>It is also preferable that a disinfectant solution is stored in some of the plurality of through holes.</p><p>The microneedle applicator is preferably provided with an adhesion measuring unit for measuring the degree of adhesion to the patient's skin, and is configured to press the microneedle base when the microneedle base is in close contact with more than a standard.</p><p>Preferably, the control unit of the microneedle applicator operates the pressing unit up and down to press the microneedle base, and after the drug injection is completed by the pressure, the injection result is transmitted to the patient terminal.</p><p>The microneedle applicator and the patient terminal preferably communicate by Bluetooth or NFC method.</p><p>It is preferable that the expert terminal can classify and manage patients according to the type of drug.</p><p>The drug compliance management method of the present invention comprises:</p><p>registering patient and expert information in a server, respectively;</p><p>a step of issuing a prescription from an expert and inputting it into a patient terminal;</p><p>Preparing a cartridge comprising a plurality of through-holes, a microneedle base positioned in the through-hole, respectively, and a microneedle formed on a lower surface of the microneedle base to deliver a drug according to a prescription;</p><p> mounting the cartridge to the microneedle applicator;</p><p>delivering a prescription from the cartridge or the patient terminal to the microneedle applicator;</p><p>Invading the microneedle into the skin by operating the pressing unit of the microneedle applicator every predetermined time according to the prescription to inject a drug;</p><p>delivering the injection result of the drug from the microneedle applicator to the patient terminal;</p><p>When there is a separate prescription other than the prescription for the microneedle, inputting the type, dose, and dosing cycle of the drug to be administered according to the separate prescription into the patient terminal, and inputting whether to administer the drug according to the dosing cycle;</p><p>transmitting drug compliance information including drug injection information by the microneedle collected in a patient terminal and dosage information according to a separate prescription to a server;</p><p>transmitting, by the server, the drug compliance information received from the patient terminal to the expert terminal;</p><p>and classifying and displaying drug compliance based on the same drug in the expert terminal.</p><p>When the microneedle drug injection fails, the control unit of the microneedle applicator transmits the cause to the patient terminal. It is desirable to include it in the information.</p><p>The patient's information includes the patient's name, age, and gender as essential information, and may optionally include height, weight, name of a substance causing an allergic reaction to the patient, and medication history.</p>

<p>According to the above configuration, the present invention has an effect that when a drug is injected periodically or repeatedly through a microneedle, the compliance with the drug to the drug injection can be accurately managed by experts such as patients and medical staff.</p><p>When injection or administration of a drug fails, it is possible to record and store the failure factors, so that countermeasures can be established.</p><p>In addition, there is an effect to prevent infection of the invasive site according to the repeated invasion of the microneedle.</p>

1 is a view showing the appearance of an embodiment of the present invention microneedle applicator. Figure 2 is a view showing an embodiment of the present invention microneedle applicator and cartridge. Figure 3 is a view for explaining the configuration of the upper side of the cartridge according to an embodiment of the present invention. Figure 4 is a view for explaining the configuration of the lower side of the cartridge according to an embodiment of the present invention. Figure 5 is a diagram for explaining the operating relationship of the microneedle applicator in one embodiment of the present invention. Figure 6 is a diagram showing an embodiment drug compliance management system of the present invention. 7 is a flowchart showing a method for managing drug adherence in an embodiment of the present invention.

Hereinafter, the present invention will be described in more detail with reference to the drawings according to embodiments thereof.

The present invention includes a microneedle applicator (1) in the form of a wearable device capable of injecting a drug by means of a microneedle, the drug injection information received from the microneedle applicator (1), and the medication information that the patient administers separately and inputs a patient terminal (2) for processing drug compliance information and; a server (3) transmitting the drug compliance information received from the patient terminal (2) to the expert terminal (4); It comprises an expert terminal 4 that displays the drug compliance information collected from a plurality of patient terminals.

The microneedle applicator 1 is a wearable device and may be in the form of a wrist watch worn on the wrist, or in the form of a band worn on parts of the body such as forearms, thighs, and waist.

The microneedle applicator 1 is not limited to that for humans, and may be used to inject drugs into animals. For example, the microneedle applicator may be manufactured as a wearable device in the form of a necklace worn on the neck of an animal. The drug compliance management system and method of the present invention are not limited to humans.

The cartridge 100 in which a plurality of microneedle bases 151 are installed is mounted on the main body 200 of the microneedle applicator 1 . On the lower surface of the microneedle base 151, the microneedle 153 to be invaded into the skin is formed. The cartridge 100 is replaced when all the drug injection by the microneedle 153 is completed.

The microneedle applicator 1 is provided with a pressing part 404 to press one microneedle base 151 to the skin side of the patient, and accordingly, the microneedle 153 is invaded into the skin and the drug is injected.

The microneedle 153 is a hollow type in which a drug is injected through the hollow of the needle, a coated type in which a drug is applied to the surface of the needle and melts in the skin (Coated Type), and the needle itself is composed of drug components It can be prepared in one of the dissolving types in which the microneedles are decomposed in the skin.

The upper surface of the microneedle applicator is formed as a display unit, and various information such as the state of the microneedle applicator is displayed. In addition, it is preferable that the display unit is provided with a touch screen to enable the manipulation of the microneedle applicator as the user touches the surface of the display unit.

In this embodiment, the pressing unit 404 is operated by the interaction of the driving source 402 which is a motor and the power transmission unit 403 which is a gear. The microneedle applicator is equipped with a rechargeable or replaceable battery to operate the driving source 402 or supply electricity to a necessary part.

The pressing part 404 of this embodiment not only moves to the skin side (lower side in FIG. 5), but also rotates from the upper side of the cartridge 100 with respect to the axis 450 to the microneedle base 151 on the cartridge 100. are pressed one by one.

Unlike the case of Figure 5 in which the pressing unit 404 rotates, the pressing unit 404 does not rotate but moves up and down toward the skin side, and instead the cartridge 100 may rotate.

The upper and lower surfaces of the cartridge 100 are covered with a thin film made of a material such as metal or synthetic resin, and each through hole 150 is sealed by the thin film adhered along the periphery of the through hole 150 of the cartridge 100 . It is possible to prevent contamination of the microneedle by such sealing.

Thereafter, when the upper surface of the microneedle base 151 is pressed by the pressing unit 404 , the microneedle 153 on the lower surface of the microneedle base 151 tears the thin film and invades the skin.

A microneedle base 151 is disposed in each through hole 150 of the cartridge 100 . The microneedle base 151 is connected to the inner wall of the through hole 150 by connecting members 157 and 159 . The microneedle base 151 pressed to the skin side by the pressing unit 404 is returned to its original position by the elastic force of the connecting member 155 when the pressing unit 404 is retracted after drug injection. The elastic force of the connecting member 155 may be obtained depending on the material or shape of the connecting member. In this embodiment, it is possible to return by the elastic force by the connecting member bent in a zig-zag manner to increase the overall length.

In this embodiment, it has been described that the microneedle base 151 is returned to its original position by the elastic force of the connecting member 155 , but the microneedle base 151 has the elastic force of the thin film attached to the upper or lower side of the through hole 150 . It may be possible to return to the original position by That is, in a state in which the upper and lower thin films are adhered to the upper surface of the microneedle base or in contact with the lower surface, the microneedle base may be restored to its original position by its own elasticity. In this case, the connecting member 155 does not need to have an elastic force and is preferably formed to be easily cut.

A disinfectant solution may be stored in some of the through holes of the microneedle. In this case, it is preferable that the microneedle installed in the through hole in which the disinfectant solution is stored is provided with only a sharp tip capable of piercing the thin film without coating the drug.

The disinfectant solution stored in the through hole flows out through the hole of the thin film perforated by the pressurizing part and the microneedle to disinfect the skin surface. Then, when the cartridge is rotated, the microneedle located in the adjacent through hole moves over the sterilized surface of the skin, and the microneedle is invaded by the pressurizing part so that the drug can be injected.

In general, it is known that the skin invaded by the microneedle is restored to its original state after about 4 hours, but if the drug is injected again within a shorter time than that, the skin may be damaged.

In order to prevent this, the number or arrangement of the microneedles 153 attached to the lower surface of the microneedle base 151 is formed differently so that the invasive site is different.

The drug supplied into the cartridge need not be limited to only one, and various drugs may be supplied by the microneedle.

As the microneedle applicator 1 in the form of a wearable device is closely adhered to the skin, it becomes easier to invade the microneedle. In order to check the degree of such adhesion, it is preferable to provide an adhesion measuring unit on the lower surface of the microneedle applicator (1). The adhesion measuring unit may be formed of an electrostatic element or a piezoelectric element to measure the adhesion degree.

The operation of the cartridge 100 or the pressing unit 404 is controlled by the control unit of the microneedle applicator 1 . The control unit of the microneedle applicator (1) is also provided with a communication function for sending and receiving various data to the patient terminal (2).

Data transfer between the microneedle applicator 1 and the patient terminal 2 is also possible by wire, but is preferably made by Bluetooth or NFC.

The patient terminal 2 transmits the drug injection information received from the microneedle applicator 1 to the expert terminal 4 via the server 3 , and the expert uses the expert terminal 4 to determine drug compliance for each patient or drug can be comprehensively reviewed.

The patient terminal and the expert terminal in the present invention may be one of the computing devices that are connected to the Internet, such as a mobile phone, a smart watch, a PDA, a notebook computer, and a desktop computer, to exchange information and process information.

In addition, when the patient terminal is formed in the form of a smart watch, the microneedle applicator and the patient terminal may be formed as one device. In this case, the microneedle applicator and the patient terminal should be understood as a part responsible for the above-described functions in one device.

The present invention compliance management system of the above configuration can be operated according to the following method.

First, information of patients and experts is registered in the server 3 .

Patient information may be registered in the server 3 through the patient terminal 2 or the expert terminal 4 . That is, the patient's information can be registered in the server by registering the patient's information to the server through the patient terminal 2 or by providing the registered patient information to the server at a medical institution.

The patient's information consists of the patient's name, age, and gender as essential information, and may further include height, weight, name of a substance causing an allergic reaction to the patient, and medication history.

An expert is a medical staff who treats, cares for, or prescribes or manufactures drugs, and may include various organizations that require medical information, such as a health care company, an insurance company, the government, a university, or a research institute.

In the following description, unless otherwise stated, experts refer to medical staff.

When a prescription is issued by a specialist who has treated the patient, the prescription is entered into the patient terminal.

The prescription may include information on the type of drug, the dosage, the frequency of administration, and the timing.

A prescription from an expert may be issued in the form of a QR code or barcode, and the prescription may be entered as the patient terminal scans the QR code or barcode, or the prescription may be transmitted directly from the expert terminal to the patient terminal through the server. will be.

The patient terminal is connected to the microneedle applicator to deliver the prescription.

A QR code or barcode is printed on the cartridge prepared to load the drug according to the prescription, and when mounted on the microneedle applicator, the microneedle applicator reads the QR code or barcode so that the prescription can be delivered to the microneedle applicator.

The cartridge and the applicator receiving the prescription will inject the drug at a predetermined time or at a predetermined interval according to the prescription.

It is preferable that the microneedle applicator warns the patient by itself or through the patient terminal before invasive of the microneedle, and the pressing unit presses the microneedle base after a confirmation input is made to the patient terminal or the microneedle applicator.

The warning to the patient may be a vibration or beep sound generated by the microneedle applicator or the patient terminal.

Before drug injection, the area where the microneedle will be invaded may be disinfected by the disinfectant solution stored in the cartridge.

A disinfectant solution is stored in some of the plurality of through-holes that are sealed at the top and bottom, and when the thin film of the through-holes in which the disinfectant solution is stored is punctured by the microneedle, the disinfectant solution flows into the microneedle invasion site and disinfects the skin surface. .

The result of injecting the drug as described above is stored in the control unit of the microneedle applicator 1 and then transmitted to the patient terminal 2 at a predetermined period or at the request of the patient terminal 2 .

On the other hand, in addition to drug injection by microneedle, the patient may have to administer it orally or as a patch according to a separate prescription. In this case, the patient's medication information may be input through the patient terminal 2 or a prescription input from the expert terminal 4 is transmitted to the patient terminal 2 .

When dosing information consisting of the type, dose, and dosing cycle of the administered drug is input, the patient administers the drug according to an alarm notified by the patient terminal 2 , and after administration, the patient terminal 2 checks whether or not the drug has actually been administered will be input

However, drug injection by the microneedle may fail because the battery of the microneedle applicator is discharged, the microneedle applicator is not mounted on the body, or the drug in the cartridge is exhausted.

In addition, administration may fail for reasons such as not being able to administer the originally prescribed medicine or not taking the medicine after ignoring the alarm from the patient terminal at the set time because another disease has occurred and a separate medicine has to be taken. it might be

The failure of such injection or administration directly affects drug compliance information, and the reason for such failure is stored in the patient terminal 2 automatically in the patient terminal or according to the patient's input.

In the drug compliance information, it is also preferable that the failure and reason for such drug injection or administration are stored at the same time.

Drug compliance information, which consists of drug injection by a microneedle collected to the patient terminal and administration information according to a separate prescription, is transmitted to the server periodically or at the request of the patient terminal.

The server transmits it to the expert terminal periodically or at the request of the expert terminal.

An expert who has reviewed each patient's drug compliance information through the expert terminal will be able to send, if necessary, instructions for taking medication to the patient terminal through the server. For drugs with low drug compliance, such drug compliance information can be used to adjust dosage or cycle by adjusting the dosage form or concentration.

In addition, as the expert terminal exchanges messages with the patient terminal through the chatting window, remote medical treatment in which the expert can identify the patient's condition and provide consultation or prescription will be possible.

The components of the exemplary devices, systems, and methods employed in accordance with the above embodiments may be composed, at least in part, of digital electronic circuits, analog electronic circuits, or computer hardware, firmware, software, or a combination thereof, and these components include a computer An operation may be controlled or executed by a program, program code, or instruction.

The description of the embodiments is provided for the purpose of illustrating the principles of the invention and its practical application, thereby enabling those skilled in the art to understand the invention having various embodiments and various modifications.

The disclosed embodiments are not intended to limit the present invention, and any of the embodiments and/or components disclosed herein may be combined with each other to form various additional embodiments not specifically disclosed. Accordingly, additional embodiments are possible and such embodiments are intended to be included within the scope of this disclosure and the present invention.

One : Microneedle applicator 2: Patient terminal 3: Server 4: expert terminal 100: cartridge 150: through hole 151: microneedle base 153: microneedle 155,157,159: connecting member 200: applicator body 402: drive source 403: power transmission unit 404: pressurization unit 450: shaft