RU157058U1 - PORTABLE DRUG SYSTEM - Google Patents

Abstract

A portable system for subcutaneous injection of medicinal solutions, consisting of a control unit connected by a radio channel through an electronic module to an external remote control, and a cartridge that includes a refillable solution tank connected to a pump, a subcutaneous catheter and needle installation unit, connected to a control unit by an electric drive connected in turn, with an electronic module and an electric power source, an adhesive membrane for installing the system on the patient’s body, characterized in that the adhesive membrane is equipped with a fix a control box, in which a control unit and a replaceable cartridge are installed, connected with each other by latches, while the subcutaneous catheter and needle installation unit is also replaceable and consists of a cylinder, inside of which there is a piston with a catheter connected to the solution reservoir through a pump , a piston conductor and a removable piston with a needle for insertion of a catheter, while the system is additionally equipped with a protective cover.

Description

The utility model relates to medicine, namely to medical instruments, and can be used for independent subcutaneous injections in the treatment of diabetes mellitus, various inflammatory diseases, etc.

The traditional method of intensive insulin therapy is based on manually injecting insulin under the patient's skin several times a day. This greatly complicates the life of the patient.

Widely used in the USSR and mass-produced by the Elektrovypryamitel plant, it was a paracorporeal drug dispenser NDL-3 dispenser. The dispenser consists of a drug injection system mounted on the patient's body. The medicine is supplied from the reservoir using a micropump, to which a signal is supplied from the control device and the computing-logic device. The dispenser is equipped with an autonomous power source and a display on which information is displayed (Proceedings of the Medical Center of the Russian State Medical University for the 100th anniversary of the University, M. 2006., pp. 230-233).

In recent years, there have been reports of the successful use of electronic metering systems for the treatment of various diseases, including diabetes. These dispensers allow you to continuously and accurately inject drugs. However, dispensers are very expensive, the cost of consumables is high.

Injection devices with means of mechanization and automation are described in several previously published patents, for example, in US patents 4529401, 4833384, 5106375, 5139484, European patents EP 143895, 293958, patent DE 2710433, applications WO 85/02546 and WO 95/24233. Some of them are suitable only for use in inpatient hospitals, while others are intended only for the administration of insulin to patients with diabetes mellitus, using special cartridges with insulin and cannot be used with other medicinal solutions.

Accordingly, there remains a need for a portable injection device that helps patients self-administer drugs under the skin.

There are various devices for administering drugs in which dosing is carried out automatically (US Pat. RF No. 1674851, 2221594).

Currently, the most effective means of compensating for diabetes are an insulin pump - automatic dispensers that can administer small doses of insulin evenly according to a given program, which can be adjusted both by the patient and the control controller according to signals from a special invasive glucose level sensor.

With insulin therapy, the drug is administered using a programmed insulin pump through a cannula, which is fixed with a plaster on the patient's body. Insulin is administered through the intradermal port of a particular design. Similar systems are produced by world famous manufacturers of medical equipment (Medtronic, Nikkiso, Roche Diagnostics) (WO 2006122048, 2006). The Medtronic MiniMed 722 insulin pump has a microelectric motor that allows you to inject insulin from the reservoir using a piston

The Paradigm-Real-Time insulin pump is known, which can measure blood sugar if a glucose sensor is connected to it, additionally installed subcutaneously to the patient, in addition to the installed main insulin delivery catheter. The signal from the sensor goes to the insulin pump and its display shows glucose measurement data in the form of a graph and a numerical value. The pump is equipped with a warning system for changes in blood sugar, has a built-in bolus calculator to correct the level of glycemia after eating. The pump offers a certain calculated dose, but its introduction is checked and confirmed by the patient himself.

A device is known - a medical system and a method of controlling a system for patients to independently conduct medical procedures (RF patent No. 2234238). The known device consists of several portable modules, of which one module is designated as the leading module. The master module controls and monitors all two-way data exchanges between itself and the rest of the modules. The modules may contain, for example, a glucometer, a dispenser, a device for dispensing a medicine and a container for storing it. Modules are capable of generating and storing data transmitted to the master module if it is within range and is active. The master module can transmit data to an external unit, such as a computer or database, for subsequent processing. The doctor, who has access to the database, assigns a therapeutic effect to the patient based on the processed data. The disadvantage of this device is the inability of the portable module autonomous adjustable control of the introduction of drugs into the patient. The management of the treatment process is carried out by the doctor only through the external unit. If the connection between the patient’s module and the external unit is broken, the portable module’s operation goes into standby mode, which is unacceptable in case of emergency medical treatment.

A device for supplying micro quantities of fluid (US Pat. PM No. 109664), comprising an electric drive and a metering pump containing discharge and suction lines, a displacement chamber with a working diaphragm and a central opening, a suction chamber with a separation diaphragm and an outlet valve with a diaphragm. The electric drive is equipped with a transitional housing, in which a metering pump is installed, fixed in it with the help of a cover-clamp.

Known paracorporal dispenser of medicinal solutions with an autonomous power source (RF Pat. PM No. 115210), consisting of an injection system of a medicinal solution connected via hydrotracts to a reservoir, a micropump, to which a signal is supplied from a control device and a computing and logical device equipped with a display.

Mobile autonomous devices for forming a therapeutic effect by introducing a pharmacological preparation into a patient are also known. An example of such devices is (US Pat. No. 2007/0093750, No. 5062841). Such devices contain a microprocessor that controls the operation of the microdoser of the pharmacological preparation, which in turn provides periodic subcutaneous injection of the drug in accordance with a predetermined program. As devices for administering drugs to a patient, for example, dispensers can be used. The disadvantage of autonomous devices for the formation of therapeutic effects (drug administration) is the functioning of a rigid, predetermined program, the lack of the possibility of forming a therapeutic effect, taking into account the continuously changing state of health. This is done in order to exclude uncontrolled drug administration, which can lead to death of the patient.

A known system for automated control of the physiological state of a patient (Pat. RF at PM No. 130851) consists of a control system with glucose control, a drug administration system and a data management system, while the control system additionally includes means for monitoring the physiological state: body temperature, heart rate and electrocardiograms, and is configured to transmit physiological state sensors to a smartphone-based control unit configured to provide for the handling of information about the content of blood glucose, body temperature, heart rate by calculating the bolus for the subsequent administration of the drug into the patient's body and a computer-related medical consultant for the correction of the system and communication with the patient.

The closest technical solution to the claimed system of subcutaneous administration of drugs, namely insulin, is an insulin pump - OmniPod (USA) (http://www.insulinpump.ru/2010/03/18/sravnitelnaya-tablica-xarakteristik-insulinovyx-pomp /). The Omnipod insulin pump consists of a main unit and a control panel connected by a radio channel to the main unit. A cartridge is located in the main unit housing, which contains a syringe-type reservoir for administering insulin solution subcutaneously, an electric drive-pusher connected to the syringe reservoir stem, and a device for subcutaneous autologous injection using a spring mechanism upon command from the control panel to insert a subcutaneous catheter. A filling unit is located on the bottom surface of the main unit, after which a syringe needle is punctured, the syringe reservoir is filled with an insulin solution. In the case of the control panel are electronic units with a power source for radio control of the main unit and the implementation of the treatment process. Additionally, it contains a glucose meter, which allows using a test strip to monitor the patient’s sugar level and correct insulin therapy by changing the commands for insulin administration in the main unit. The tank is integrated inside the pump and does not change. The tank is designed for 180 units. The pump itself is programmed to shut off after 80 hours. Therefore, if the consumption of insulin is more than 54 units per day, then the pump will turn off and require a change more than once every 3 days. The pump uses a piezo motor, which provides a step of basal insulin injection of 0.025 units / hour. There are also built-in batteries.

The disadvantages of the prototype are: the inability to reuse the pump to patients since it is designed for single use only for 3 days; the lack of multiple replaceable devices for the installation of a subcutaneous catheter; the inability to replace the reservoir for insulin with a new one; the inability to replace power supplies; sticking the pump to the patient’s skin once (the adhesive membrane cannot be replaced). In this regard, the prototype pump must be changed completely in the patient every three days, which makes the treatment process unacceptably expensive for most patients.

A distinctive feature of the prototype from all existing insulin pumps Medtronic and Dysetronic, representing analogues, is the absence of intermediate catheter systems between the pump and the subcutaneous catheter

The problem solved by the proposed technical solution is to eliminate the disadvantages of the prototype due to the presence of replacement blocks and individual nodes of the system.

The technical result is achieved through the use of a portable system for subcutaneous administration of medicinal solutions, consisting of a control unit connected by a radio channel through an electronic module to an external remote control, and a cartridge that includes a solution tank, a reservoir filling unit, a pump, a subcutaneous catheter and needle installation unit, connected to the control unit using an electric drive, connected in turn with an electronic module and a power source, an adhesive membrane for installing the system on the patient’s body . The adhesive membrane is equipped with a fixing box, in which the control unit and cartridge are installed, connected by latches, and the subcutaneous catheter and needle installation unit consists of a cylindrical body, inside of which there is a piston with a catheter, a piston-conductor and a piston with a needle, and the system additionally equipped with a protective cover.

Means of control and adjustment of parameters are standard, as in any automated systems - sensors, recorders, controllers. Communications are wireless.

The inventive utility model is illustrated by the following figures.

Figure 1. A portable system for subcutaneous administration of a drug solution consisting of a cartridge (A) and a control unit (B). The cartridge (A), in turn, consists of a removable subcutaneous catheter insertion unit with a needle (B), including 16 - a cylinder, inside of which 1 - a piston with a catheter, 2 - a conductor piston, 3 - a piston with a needle, and block (G) including 4 - a pump, 5 - a reservoir with a solution, 6 - a node for filling a reservoir with a medicinal solution. The cartridge is equipped with rubber seals for tightness after a needle puncture - 7.

The control unit (B) includes 8 - an electronic module connected by a radio channel to an external remote control, 9 - an electric drive that ensures the operation of the pump 4, 10 - a power source (can be replaced if necessary).

Figure 2. The principle of operation of the subcutaneous catheter installation site (B), where pos. 2.1. - starting position, 2.2. - the introduction of a catheter with a needle under the skin, 2.3. - the piston with the needle (3) is removed, the device is ready for operation.

Figure 3. Installation of a portable system on the patient’s body, where 11 is an adhesive tape for additional fixation, 12 is an adhesive membrane with a fixing box 13, 14 is a protective cover.

Figure 4. General view of a portable system for subcutaneous administration of medicinal solutions, where 15 are latches.

Figure 5. General view of the cartridge (A) with a retractable subcutaneous catheter insertion unit with a needle (B).

Figure 6. Assembly diagram of a portable system for subcutaneous administration of a drug solution.

A portable system for subcutaneous administration of drug solutions, controlled by a radio channel, contains interconnected cartridge (A) and a control unit (B) using latches (15). In turn, the cartridge (A) has a subcutaneous catheter installation site (B), which can be replaced. The cartridge can also be completely replaced, depending on the need. An electronic module (8) connected by a radio channel to an external remote control is made in the form of a smartphone. Using the electric drive (9), the operation of the pump (4) and the electronic module (8) are provided, which are connected to the power supply (10).

The installation of the system is as follows.

Initially, the tank (5) is filled with the drug solution through the filling unit (6) using a sterile syringe (not shown in the figure) filled with a solution of insulin, for example, by piercing the rubber seal (7) with a needle from the syringe. Next, the cartridge (A) and the control unit (B) are connected using latches (15). After that, the whole system is installed in a fixing box (13), mounted on an adhesive membrane (12), and is additionally fixed in it with adhesive tape (11). The lower protective film is removed from the adhesive membrane (12). After that, the entire system is glued to a selected area of the skin. Then a subcutaneous catheter is installed as indicated in Fig. 2. After installing a subcutaneous catheter, a protective cover (14) is installed on the system, which has an adhesive surface around the perimeter. Now the system is ready to work using an external remote control.

Thus, the possibility of replacing disposable consumables in the proposed system ensures its longer use and cost savings. The application of the proposed layout of the system reduces its dimensions and reduces the cost. The inventive utility model provides automated control of the physiological state of the patient, significantly reduces the risk of critical conditions, provides the possibility of continuous monitoring by the doctor.

Claims (1)

A portable system for subcutaneous injection of medicinal solutions, consisting of a control unit connected by a radio channel through an electronic module to an external remote control, and a cartridge that includes a refillable solution tank connected to a pump, a subcutaneous catheter and needle installation unit, connected to a control unit by an electric drive connected in turn, with an electronic module and an electric power source, an adhesive membrane for installing the system on the patient’s body, characterized in that the adhesive membrane is equipped with a fix a control box, in which a control unit and a replaceable cartridge are installed, connected with each other by latches, while the subcutaneous catheter and needle installation unit is also replaceable and consists of a cylinder, inside of which there is a piston with a catheter connected to the solution reservoir through a pump , a piston conductor and a removable piston with a needle for insertion of a catheter, while the system is additionally equipped with a protective cover.

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