KR102247483B1 - Peroral drug delivery device - Google Patents

Abstract

The disclosed invention relates to a swallowable oral material delivery device, comprising: a driving unit including an actuator and a cylinder moving linearly by the actuator; and a material accommodating unit comprising a first chamber accommodating a piston moving linearly in association with the cylinder and a first deactivation material, a second chamber accommodating a second material activating the first material, a separation membrane separating the first chamber and the second chamber from each other, and an outlet membrane closing an outlet for communicating any one of the first chamber and the second chamber with an external environment; a sensing unit detecting the movement or location of the material delivery device; and a control unit configured to receive a signal provided from the sensing unit and control the operation of the actuator based on the received signal.

Description

Oral substance delivery device {PERORAL DRUG DELIVERY DEVICE}

The present invention is an oral small substance delivery device that can be swallowed by humans, and releases the substance after a delivery device containing an arbitrary substance is stably delivered to target organs (stomach, small intestine, large intestine) of the digestive system when oral ingestion It relates to an oral mass delivery device configured to be able to.

The technology to effectively introduce various substances, drugs, microorganisms, etc. (hereinafter collectively referred to as "substances") that can expect physiological or pharmaceutical effects on animals (including humans) to target organs inside animals It's just as important as developing itself. For example, if a substance that can be effective only when it reaches the small intestine when administered orally does not pass properly through the stomach, the original desired effect will be difficult to manifest, and if an anticancer drug for cancer treatment does not reach enough cancer tissues, this Again, the therapeutic effect is bound to be insignificant.

There are various methods devised for effective substance delivery to target organs inside the living body.In the case of oral formulations, several layers of coating material are covered on the surface of the drug to protect the drug until it reaches the target organ. Substances are also injected directly into target organs invasively. In recent years, small devices that release substances are attached directly or indirectly to target organs (for example, installed on the skin) to deliver substances periodically for a long period of time. For example, microscopic robots are being developed that move around the bloodstream in order to regularly inject insulin preparations into diabetic patients.

A lot of research is required to effectively deliver a simple substance or drug into a living body, but it is even more difficult to introduce a living microorganism (for example, lactic acid bacteria) into a target organ in a living body. Since handling living microorganisms itself is sensitive to contamination, it is difficult to put them into living organisms in an uncontrolled environment. In order to alleviate this limitation, the lyophilized strain is coated with various substances to protect it in several layers and then delivered in the intestine in the form of an oral preparation, but it is difficult to deliver it to the correct location, and even if delivered, when it is activated in a lyophilized state. It takes time, and it has to compete with the intestinal microbes that already live, but there is a problem that practical effects cannot be expected because the number of activated microbes is not sufficient.

Korean Patent Publication No. 10-2019-0123261 (published on October 31, 2019)

The present invention relates to an oral mass delivery device containing a substance having a physiological or pharmaceutically positive effect on a living body, after being stably delivered to a target organ, for example, the stomach, small intestine, or large intestine of the digestive system when oral ingestion An object thereof is to provide an oral mass delivery device configured to release an activated substance.

The present invention relates to a swallowable oral mass transfer device, comprising: an actuator and a drive unit including a cylinder linearly moving by the actuator; and a piston linearly moving in conjunction with the cylinder, and accommodating an inactivated first material. A first chamber, a second chamber accommodating a second material activating the first material, a separation membrane separating the first chamber and the second chamber from each other, and any one of the first chamber and the second chamber A material receiving unit including a discharge port membrane in which the discharge port communicating with the external environment is closed; and a sensing unit configured to grasp the movement or position of the material transfer device; And a controller configured to receive a signal provided from the sensing unit and control an operation of the actuator based thereon.

In one embodiment of the present invention, the cylinder and the piston are physically connected, but the sealing state of the material receiving portion can be maintained at all times. In another embodiment, the cylinder and the piston are physically separated while each including a magnetic material, and the The magnetic poles of the magnetic bodies may be arranged such that a repulsive force acts between the cylinder and the piston.

In addition, the first material may be a lyophilized microorganism strain, and the second material may be a culture medium. In one embodiment of the present invention, the first material is a Helicobacter bacteria inhibiting lactic acid bacteria, Lactobacillus bacteria, or Bifido bacteria, The target organs of the mass transfer device are the stomach, the small intestine, and the large intestine, respectively.

In addition, the separation membrane is ruptured according to the movement of the piston by a predetermined distance, and accordingly, the first material and the second material are mixed to activate the first material. In one embodiment of the present invention, the first material is frozen. It is a dried microbial strain, the second material is a culture solution, and the rupture of the separator is made prior to oral ingestion.

And, after the first material is activated or cultured, and the mass transfer device reaches the target organ, the piston moves a predetermined distance to rupture the outlet membrane, and after the outlet membrane is ruptured, the piston is It will move according to the emission profile defined in.

Meanwhile, the sensing unit includes at least one of a dissolved oxygen sensor, a pH sensor, an inertial sensor, and a timer.

In one embodiment of the present invention, the first material is a lyophilized microbial strain, the second material is a culture medium, and the target organ of the material delivery device may be a digestive organ, wherein the control unit is the dissolved oxygen sensor The large intestine is distinguished from the gastrointestinal and small intestine from the oxygen concentration according to the signal of, and the gastrointestinal and small intestine are distinguished based on the acidity according to the signal of the pH sensor, and the speed of the mass delivery device according to the signal of the inertial sensor and the timer. It is possible to distinguish the large intestine from the stomach and the small intestine by detecting and acceleration, and to determine which digestive organs have passed after oral ingestion according to the signal of the timer.

In addition, when the sensing unit includes a plurality of sensors selected from a dissolved oxygen sensor, a pH sensor, an inertial sensor, and a timer, the control unit comprehensively evaluates and determines whether the material delivery device has reached a target organ. can do.

For example, the control unit may evaluate the plurality of sensor signals with an AND condition to determine whether they have reached a target organ, or assign a weight to each of the plurality of sensor signals, and assign a weight to each of the plurality of sensor signals. The sensor signals may be quantitatively summed to determine that the target organ has been reached when a predetermined criterion is exceeded.

In addition, the driving unit and the material receiving unit are each disposed in a separate body from each other, but the combined body may maintain airtightness.

In addition, it may be preferable that at least the material receiving portion is in an environment in which oxygen is removed, for example, in a nitrogen environment.

Since the oral mass delivery device of the present invention having the above configuration releases the activated substance for an appropriate time after reaching the target organ, the efficiency of mass delivery is very excellent.

In particular, in the case of delivering lactic acid bacteria as a delivery material, a small amount of the strain and the culture medium for growing it are separated in a freeze-dried form and prepared in the device. Since the live lactic acid bacteria can be released directly to the target organ after the culture is completed, a much superior effect can be obtained compared to the conventional oral formulation method of delivering the lactic acid bacteria.

In addition, since the lyophilized strain is cultured in the mass transfer device and then delivered directly to the target organ, the amount of strain required can be greatly reduced, side effects on the human body can be minimized, and the production cost can be greatly reduced.

In addition, the oral mass delivery device of the present invention does not need to observe or control the introduction process using an external device as it determines whether it has reached the target organ through its own sensor. In other words, the oral mass transfer device of the present invention is a completely independent mass transfer device, and it is clinically convenient and user's convenience is not different from general oral preparations because all operations are performed by magnetic force after oral ingestion. great.

1 is a view showing the appearance of an oral mass delivery device according to the present invention.
FIG. 2 is a diagram schematically showing the internal configuration of the oral mass delivery device of FIG. 1.
FIG. 3 is a view showing a state in which the separation membrane is ruptured according to the movement of the piston in the oral mass transfer device of FIG. 2 (initiated culture state).
FIG. 4 is a view showing a state in which a piston ruptures an outlet membrane and releases an activated material in the oral mass transfer device of FIG. 3.
5 is a diagram showing an embodiment of a sensing unit.
6 is a view schematically showing an example of releasing a substance after a movement time for each digestive organ and an oral mass delivery device reaches the ascending colon of the large intestine.

The present invention is intended to illustrate specific embodiments and to be described in detail in the detailed description, since various transformations may be applied and various embodiments may be provided. However, this is not intended to limit the present invention to a specific embodiment, it should be understood to include all conversions, equivalents, and substitutes included in the spirit and scope of the present invention.

The terms used in the present invention are used only to describe specific embodiments, and are not intended to limit the present invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. In the present invention, terms such as'include' or'have' are intended to designate the presence of features, numbers, steps, actions, components, parts, or a combination thereof described in the specification, but one or more other features. It is to be understood that the presence or addition of elements or numbers, steps, actions, components, parts, or combinations thereof does not preclude in advance.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings. In this case, it should be noted that the same components in the accompanying drawings are indicated by the same reference numerals as possible. In addition, detailed descriptions of known functions and configurations that may obscure the subject matter of the present invention will be omitted. For the same reason, some elements in the accompanying drawings are exaggerated, omitted, or schematically illustrated.

1 is a view showing the appearance of an oral mass delivery device 10 according to the present invention. The mass delivery device 10 of the present invention is an oral type that is introduced into the digestive tract through the mouth, and has the size of a conventional oral preparation and is manufactured in a size that is not burdensome to swallow. The oral mass transfer device 10 is made of a material that is not damaged by digestive fluids such as gastric acid or interest fluid, and has airtightness in which fluids such as digestive fluid or moisture, food during digestion, and the like do not penetrate into the interior. In the oral mass transfer device 10 of FIG. 1, it is exemplarily shown that the dissolved oxygen sensor 310 or the electrode of the pH sensor 320 included as the sensing unit 300 is exposed on the surface.

FIG. 2 is a diagram schematically showing the internal configuration of the oral mass delivery device 10, and corresponds to an initial state in which it is not activated before oral ingestion.

Referring to FIG. 2, the oral mass delivery device 10 of the present invention is divided into a large size and includes a driving unit 100, a material receiving unit 200, a sensing unit 300, and a control unit 400. In addition, a driving unit 100 including electric and electronic devices, a sensing unit 300, and a power supply unit 500 for supplying power to the control unit 400 are also included, and the power supply unit 500 is a common and common component. Therefore, detailed description is omitted.

The driving unit 100 includes an actuator 110 and a cylinder 112 that is linearly moved by the actuator 110. The actuator 110 is preferably a linear motor in terms of size, but it is also possible to implement a structure including a mechanism for converting rotational motion into linear motion.

The material accommodating part 200 includes first and second chambers 210 and 220 and two types of membranes that are ruptured to enable material movement when necessary. The first chamber 210 is a type of container that accommodates the piston 214 linearly moving in conjunction with the cylinder 112 of the driving unit 100 and the deactivated first material 212. In addition, the second chamber 220 is a container accommodating a second material 222 that is activated by reacting with the first material 212 that is inactivated. Here, the first chamber 210 and the second chamber 220 in the initial state are separated from each other by the separator 230, that is, physically and chemically separated. The other membrane is the outlet membrane 242 and closes the outlet 240 for communicating one of the first chamber 210 and the second chamber 220 with the external environment.

Here, the first chamber 210 is described as accommodating the deactivated first material 212, and the second chamber 220 is described as accommodating the second material 222 for activation. It may be configured by accommodating the second material 222 in the first chamber 210 and the first material 212 in the second chamber 220. However, in one embodiment to be described below, the first material 212 is a lyophilized strain (a strain of microorganisms having a specific beneficial effect), and the second material 222 is a culture solution. In this case, the first chamber 210 ) By providing a free space in the piston 214 is moved to rupture the separation membrane 230, it is only explained because it is easier to suppress the excessive pressure from acting on the first chamber 210.

The sensing unit 300 is a component including one or more sensors capable of grasping the movement or position of the material delivery device 10. In the present invention, by providing the sensing unit 300, the oral mass transfer device 10 can function as a completely independent mass transfer device 10 capable of self-determining whether or not the oral mass transfer device 10 has reached the target organ. That is, by providing the sensing unit 300, there is no need to observe or control the introduction process of the mass transfer device 10 into the body using an external device, which will be described in detail in the relevant part.

In addition, the controller 400 receives a signal provided from the sensing unit 300 and is in charge of general control for controlling the operation of the actuator 110 based on the received signal. Since the configuration of the control unit 400 itself is a well-known and commonly used technology, detailed descriptions will be omitted, and a description will be made focusing on a control algorithm in a necessary part.

As described above, the oral mass transfer device 10 of the present invention separates the container containing the material into the first chamber 210 and the second chamber 220, and is inactivated in the first chamber 210. It is characterized in that the first material 212 and the second chamber 220 are configured to contain a second material 222 for activation. This configuration brings great advantages in many ways. That is, when the first substance 212 and the second substance 222 are mixed to exert a meaningful physiological and pharmacological effect, the oral substance delivery device 10 is prepared according to the time point at which the best effect is exhibited after oral ingestion. Since the first substance 212 and the second substance 222 can be mixed, excellent results can be expected compared to the case of mixing and ingesting them in advance. In addition, when the first substance 212 exhibits its main function or is easily contaminated or deteriorated, the first substance 212 can be stored while maintaining it in a state (inactive state) that can be stored for a long period of time. The expiration period of the delivery device 10 can be sufficiently ensured.

Furthermore, in the case where the first material 212 is a microorganism having a specific medicinal effect that is beneficial to the body, only a minimum of strains are accommodated in the first chamber 210 and can be grown in the body with the second material 222, a culture drug. Therefore, the amount of strain required can be greatly reduced, side effects on the human body can be minimized, and production costs can be greatly reduced. For example, by accommodating a strain lyophilized with the first material 212 and accommodating the culture medium as the second material 222, the oral material delivery device 10 may be configured.

More specifically, the first material 212 may be a strain of a lyophilized microorganism, and in this case, the target organ of the oral material delivery device 10 is a digestive organ (stomach, small intestine, large intestine). Microorganisms that can exert beneficial medicinal effects on the digestive system include lactic acid bacteria that inhibit Helicobacter bacteria in the stomach, Lactobacillus bacteria in the small intestine, and Bifidobacterium species (abbreviated as "Bifido bacteria") in the large intestine.

However, the useful microorganisms mentioned above are only an example, and not only can target various microorganisms, but also many more microorganisms may be of interest in the present invention as microbial research proceeds. For example, as anaerobic microorganisms useful in the large intestine, the next-generation probiotics Akkermansia (effective for diabetes, obesity, and immunity), short-chain fatty acid producing microorganisms, Faecalibacterium and Clostridium. , And Bacteroides, an immunosuppressive microorganism. Therefore, microorganisms capable of exerting the beneficial medicinal effects mentioned in the present invention must be broadly interpreted.

In order for living microorganisms to be activated and effective in the digestive system, a certain number or more is required. For example, more than 100 million Bifidobacteria that are effective in the large intestine are required, so the number of strains must be at least 100,000, and 100,000 to million Bafido strains freeze-dried are cultured and more than 100 million. Is multiplied. The form of the strain is a lyophilized powder and the culture solution is accommodated in a liquid state, and the weight ratio between the strain and the culture solution is about 1:10. In addition, the aerobic strain requires oxygen, but the anaerobic strain can be cultured and alive only when the first chamber 210 and the second chamber 220 are kept in an oxygen-free state. Preferably, the first chamber 210 and the second chamber 220 may be filled with nitrogen to create an oxygen-free environment. For example, the first chamber 210 and the second chamber 220 are filled with the first material 212 and the second material 222 in an anaerobic condition filled with nitrogen, and the second chamber 220 is After the culture solution is filled in, the lyophilized strain is filled in the first chamber 210 after sterilization by various methods (EOS gas, electron beam, etc.).

In this way, since the first chamber 210 and the second chamber 220 of the material receiving unit 200 contain substances that affect the living body, they must be sealed from other components including the driving unit 100. There is a need. In particular, in the case of accommodating the strain and the culture medium, it is important to maintain an airtight state because it is more sensitive to contamination from the outside.

In particular, since the first chamber 210 of the material receiving unit 200 has a piston 214 interlocking with the cylinder 112 of the driving unit 100, there is a difference between the driving unit 100 and the material receiving unit 200. It is important to keep the confidentiality of the company. For example, even if the cylinder 112 and the piston 214 are physically connected (for example, by a rod), a sealing means is provided at the physical connection, so that the sealing state of the material receiving part 200 is always maintained. It should be.

More preferably, referring to FIG. 2, in order to maintain a good sealing state of the material receiving portion 200, the cylinder 112 and the piston 214 are physically separated while each including a magnetic material. , The magnetic poles of each magnetic body are arranged so that a repulsive force acts between the cylinder 112 and the piston 214. In this way, when the repulsive force of the magnetic body is used, the physical connection between the cylinder 112 and the piston 214 becomes unnecessary, and thus the sealed state can be easily maintained.

In addition, in such a magnetic driving structure, it is easy to make a structure in which the driving unit 100 and the material receiving unit 200 are respectively disposed in separate bodies, manufactured separately, and then combined into a single body. By separating the driving unit 100 from the material receiving unit 200 and separately manufacturing the material receiving unit 200, it is easy to implement the airtight structure of the material receiving unit 200. The sensing unit 300, the control unit 400, and the power supply unit 500 are preferably disposed together with the driving unit 100, but due to the narrow space arrangement, at least some of them may be disposed on the side of the material receiving unit 200. There will be. The combined body must also be kept airtight with respect to the external environment, and the oral mass transfer device 10 is sterilized and then airtightly packaged.

3 is a view showing a state in which the separation membrane 230 is ruptured according to the movement of the piston 214 in the oral mass transfer device 10 of FIG. 2. Compared with FIG. 2, in the state of FIG. 3, as the actuator 110 operates and the cylinder 112 moves toward the material receiving part 200, the piston 214 moves a predetermined distance in connection therewith, so that the separation membrane 230. This is a ruptured state. The separation membrane 230 may rupture due to an increase in pressure due to the compression action of the piston 214, but as shown, a kind of needle 215 protruding from the end of the piston 214 may stab and rupture the separation membrane 230. have. The rupture of the separator 230 once made in a part may be propagated as a whole, and as the isolation state is released due to the rupture of the separator 230, the first material 212 and the second material 222 are mixed to form the first material. (212) is activated.

An appropriate time point at which the separation membrane 230 is ruptured is determined in consideration of the characteristics of the material accommodated in the oral mass transfer device 10. If the best effect appears within a few minutes after the first material 212 and the second material 222 are mixed, it will be appropriate to rupture the separator 230 several minutes before material delivery (release). Conversely, if the first material 212 is a lyophilized microbial strain and the second material 222 is a culture medium, a time is required to proliferate the strain to more than 100 million animals more than 10 times. For example, the target organ of Bifidobacteria is the large intestine, and it usually takes about 2 hours to pass through the stomach, 4 hours to pass through the small intestine, and proliferates more than 100 million Bifido strains with a culture time of about 6 hours. I can make it. Therefore, in this case, it would be preferable that the separation membrane 230 is ruptured before (just before) oral ingestion. In other words, the cultivation time of the microbial strain should take into account the time it takes to reach the target organ, and therefore, the separation membrane 230 must be ruptured at an appropriate time by comparing both the time to reach the target organ and the time required for cultivation.

When the oral mass transfer device 10 is ingested after the separation membrane 230 is ruptured, the mass transfer device 10 rotates or swings due to the movement of the digestive system (interlocking motion, segmental motion, etc.). The freeze-dried microbial strain and the culture solution are evenly mixed to create an appropriate culture environment.

4 is a view showing a state in which the piston 214 ruptures the outlet membrane 242 and releases the activated material in the oral mass transfer device 10 of FIG. 3. That is, FIG. 4 shows a state in which the first material 212 and the second material 222 are mixed and transferred to the outside after the material delivery device 10 arrives at the target organ. Compared with FIG. 3, in FIG. 4, the piston 214 is further moved a predetermined distance, and accordingly, the discharge port membrane 242 blocking the discharge port 240 provided in the second chamber 220 is ruptured. According to the rupture of the outlet membrane 242, the first chamber 210 and the second chamber 220 communicated with the external environment, and thus, according to the movement of the piston 214 after the outlet membrane 242 is ruptured. The activated first substance 212 is delivered to the target organ.

The release of the substance may occur at one time or may be continuously and slowly proceeded for an appropriate period of time. That is, the piston 214 moves according to a predefined release profile (time vs. stroke). In the case of Bifidobacteria, the travel time in the large intestine usually occurs slowly enough to exceed at least one to two days. In addition, since the length of the large intestine is 180 cm and the ascending colon is 25 to 30 cm, an appropriate release profile can be set in advance in consideration of the moving speed and distance (time) of the mass transfer device 10. The oral mass delivery device 10 after all the material release process is completed is discharged from the body along with the bowel movement (recovery or disposal treatment).

In the above, the first material 212 and the second material 222 are protected and accommodated in the oral material delivery device 10 of the present invention, and the separation membrane 230 is ruptured at an appropriate time to form the first material 212. A configuration for activating and releasing the activated first substance 212 after arriving at the target organ has been described. However, another important point is to recognize that the oral mass delivery device 10 has arrived at the target organ. Conventionally, this has been determined by performing bidirectional communication with the oral mass transfer device 10 or observing using external ultrasound imaging or angiography. However, this method causes considerable inconvenience in the clinical operation of the oral mass delivery device 10. Therefore, the present invention consists of a completely independent mass transfer device 10 that can determine whether the oral mass transfer device 10 has reached the target organ by itself, and after oral ingestion, all operations can be performed by magnetic force. Made it possible.

As described above, the oral mass delivery device 10 of the present invention includes one or more sensors capable of grasping its movement or position, and includes a sensing unit 300. Various sensors provided in the sensing unit 300 may vary depending on where the body is put into the body, and taking a human digestive system as an example, the sensing unit 300 includes a dissolved oxygen sensor 310, a pH sensor 320, and an inertial sensor ( At least one or more of 330) and timer 340 may be included.

Since the inertial sensor 330 and the timer 340 are well-known and common technologies widely used in general home appliances such as smartphones, a detailed description will be omitted, but the dissolved oxygen sensor 310 and the pH sensor 320, which are electrochemical sensors. This will be described in more detail with reference to FIG. 5.

The dissolved oxygen sensor 310 is a sensor that measures the concentration of oxygen dissolved in a fluid. 5, as the dissolved oxygen sensor 310, a plurality of electrodes such as a counter electrode (CE), a working electrode (WE), and a reference electrode (RE) are provided on the surface of the mass transfer device 10. Are exposed to. The dissolved oxygen concentration can be measured using an electrochemical technique such as cyclic voltammetry through a plurality of electrodes.

The pH sensor 320 is a sensor that measures acidity, and may determine the acidity by measuring the concentration of hydrogen ions in a liquid. The pH value can be measured using a sensor such as an ion sensitive field effect transistor, and a gate insulator acting as the ion sensitive surface of the ion sensitive field effect transistor is used as a mass transfer device (10). It can be implemented by exposing it to the surface of ).

The principle of distinguishing the digestive system using the measurement information of each sensor is as follows. The signal measured by each sensor is transmitted to the controller 400 and evaluated.

First, the dissolved oxygen sensor 310 measures the dissolved oxygen concentration, which is the most important factor for identifying the large intestine. The large intestine, particularly the ascending colon, has an extremely low oxygen concentration of 0 or very close to 0, and through this, the large intestine can be clearly distinguished from the gastrointestinal and small intestine in which oxygen is present.

In addition, the pH sensor 320 acquires information on acidity, which is a major factor identifying the stomach and the small intestine. Since the pH in the stomach is strong acidic of 2-3, and the pH in the small intestine is weakly alkaline (the further away from the stomach, the more alkaline), the stomach and small intestine can be identified through acidity information.

In addition, the inertial sensor 330 and the timer 340 may grasp motion information such as speed and acceleration of the oral mass transfer device 10. Since the mass transfer device 10 passes through the esophagus, it takes a short time of several seconds, it usually takes about 2 hours to pass through the stomach, and about 4 hours to pass through the small intestine, whereas it takes at least one day or more in the large intestine. Information capable of estimating the digestive tract can also be obtained from the speed and acceleration of the oral mass delivery device 10. For example, in the large intestine, the moving speed rapidly decreases, so this becomes important information for estimating that the mass transfer device 10 has arrived in the large intestine. In addition, the motion information of the mass transfer device 10 is also used to control the release of a substance according to a predetermined release profile for an appropriate time.

In addition, the time measured by the timer 340 itself also provides minimum information for determining whether a time enough to pass through the stomach, small intestine, and large intestine has elapsed after oral ingestion. In other words, it takes less than 10 minutes to completely reach the stomach through the esophagus, 2 hours to pass through the stomach, and 4 hours to pass through the small intestine. It becomes information.

It would be more preferable to have a plurality of these various sensors. That is, it is theoretically, probabilistic, and empirically more accurate to comprehensively determine whether the oral mass transfer device 10 containing useful microbial strains has reached the target digestive tract based on various measurement information.

For example, the controller 400 may evaluate a plurality of sensor signals with an AND condition to determine whether the large intestine has been reached. For example, if the dissolved oxygen concentration is 0 and all the conditions that 6 hours have elapsed after oral ingestion are satisfied, it can be concluded that the colon has been reached. However, the AND condition can be determined in a stable manner, but as the number of sensors increases, it can become a tricky condition that satisfies all conditions at the same time becomes increasingly strict. Moreover, if an error occurs in any one sensor, the condition is satisfied forever. Because it cannot be done, appropriate security measures are required.

Alternatively, the control unit 400 may determine that the large intestine is reached when a predetermined criterion is exceeded by assigning weights to each of the plurality of sensor signals and qualitatively summing each of the weighted sensor signals. have. For example, an evaluation index corresponding to each measured value such as dissolved oxygen concentration, pH value, and moving speed is calculated (the evaluation index is calculated in advance), and the weight assigned in consideration of the importance of each sensor is calculated. If the sum of all the applied conversion evaluation indices exceeds a certain standard value, it is judged that it has reached the target organ. This method has the advantage that it is possible to evaluate important factors more importantly, is not absolutely affected by any one criterion, and it is easy to find an appropriate compromise even if an error occurs in any one sensor.

6 is a diagram schematically showing an example of releasing a substance after the oral mass delivery device 10 reaches the ascending colon of the large intestine. Before ingesting the oral mass transfer device 10, the separation membrane 230 is ruptured as shown in FIG. 3, and the first material 212 (Bifido strain) and the second material 222 (culture solution) are mixed and cultured. Will be in a state. The oral mass transfer device 10 introduced into the digestive tract causes fluctuations such as rotation due to the movement of the digestive tract in the intestine, and accordingly, the strain and the medium are actively mixed, and the strain is activated while being cultured. While moving within the intestine, the control unit 400 of the oral mass transfer device 10 analyzes various information identified through the sensing unit 300 to determine whether the target organ (large intestine) has been reached, and when the target is reached, the control unit 400 As shown in 4, the outlet membrane 242 is ruptured and activated Bifidobacteria are discharged according to a preset release profile. And, finally, the oral mass transfer device 10 is discharged to the outside of the body through the bowel movement, and the discharged oral mass transfer device 10 is recovered or discarded.

The above description is merely illustrative of the technical idea of the present invention, and those of ordinary skill in the art to which the present invention pertains will be able to make various modifications and variations without departing from the essential characteristics of the present invention. Accordingly, the embodiments disclosed in the present invention are not intended to limit the technical idea of the present invention, but to explain the technical idea, and the scope of the technical idea of the present invention is not limited by these embodiments.

10: oral mass delivery device
100: drive unit 110: actuator
112: cylinder 200: material receiving portion
210: first chamber 212: first material
214: piston 215: needle
220: second chamber 222: second material
230: separator 240: outlet
242: outlet membrane 300: sensing unit
310: dissolved oxygen sensor 320: pH sensor
330: inertial sensor 340: timer
400: control unit 500: power supply unit

Claims (25)

As a swallowable oral mass delivery device,
A driving unit including an actuator and a cylinder linearly moved by the actuator;
A first chamber accommodating a first material deactivated and a piston linearly moving in conjunction with the cylinder, a second chamber accommodating a second material activating the first material, the first chamber and the second chamber A material receiving portion including a separation membrane for isolating each other, and an outlet membrane in which an outlet for communicating one of the first chamber and the second chamber with an external environment is closed;
A sensing unit to determine the movement or position of the mass transfer device; And
A control unit receiving a signal provided from the sensing unit and controlling an operation of the actuator based thereon;
Oral mass delivery device comprising a. As a swallowable oral mass delivery device,
A driving unit including an actuator and a cylinder linearly moved by the actuator;
A first chamber accommodating a second material and a piston linearly moving in conjunction with the cylinder, a second chamber accommodating a first material in an inactive state activated by the second material, the first chamber and the second A material receiving unit including a separation membrane for separating the chambers from each other, and an outlet membrane in which an outlet for communicating one of the first chamber and the second chamber with an external environment is closed;
A sensing unit to determine the movement or position of the mass transfer device; And
A control unit receiving a signal provided from the sensing unit and controlling an operation of the actuator based thereon;
Oral mass delivery device comprising a. The method according to claim 1 or 2,
The oral mass delivery device, characterized in that the material receiving portion is sealed from other components including the driving portion. The method of claim 3,
The cylinder and the piston are physically connected but the sealing state of the material receiving portion is always maintained. The method of claim 3,
The cylinder and the piston are physically separated while each including a magnetic body, the magnetic poles of the oral mass transfer device, characterized in that arranged so that a repulsive force acts between the cylinder and the piston. The method according to claim 1 or 2,
The first material is a lyophilized microbial strain, and the second material is a culture medium. The method of claim 6,
The first substance is a Helicobacter bacteria inhibiting lactic acid bacteria, Lactobacillus bacteria, or Bifido bacteria, and the target organs of the mass delivery device are the gastrointestinal, the small intestine, and the large intestine, respectively. The method according to claim 1 or 2,
The oral mass delivery device, characterized in that the separation membrane is ruptured according to the movement of the piston by a predetermined distance, and accordingly, the first material and the second material are mixed to activate the first material. The method of claim 8,
The first material is a lyophilized microbial strain, the second material is a culture solution, and the separation membrane is ruptured prior to oral ingestion. The method of claim 8,
After the first material is activated and the mass transfer device reaches the target organ, the piston moves a predetermined distance to rupture the outlet membrane. The method of claim 9,
After the first material is cultured and the mass transfer device reaches the target organ, the piston moves a predetermined distance to rupture the outlet membrane. The method of claim 10,
After the outlet membrane is ruptured, the piston moves according to a predefined release profile. The method of claim 11,
After the outlet membrane is ruptured, the piston moves according to a predefined release profile. The method according to claim 1 or 2,
The sensing unit comprises at least one of a dissolved oxygen sensor, a pH sensor, an inertial sensor, and a timer. The method of claim 14,
The first material is a lyophilized microbial strain, the second material is a culture medium, and the target organ of the material delivery device is a digestive organ. The method of claim 15,
The control unit is an oral mass delivery device, characterized in that to distinguish the large intestine from the gastrointestinal and small intestine from the oxygen concentration according to the signal of the dissolved oxygen sensor. The method of claim 15,
The control unit is an oral mass delivery device, characterized in that to distinguish between the stomach and the small intestine based on the acidity according to the signal of the pH sensor. The method of claim 15,
Wherein the control unit detects the speed and acceleration of the mass transfer device according to signals of the inertial sensor and the timer, and distinguishes the large intestine from the stomach and the small intestine based on this. The method of claim 15,
The control unit, according to the signal of the timer, the oral mass delivery device, characterized in that to determine whether a time to pass through a certain digestive system after oral ingestion. The method of claim 14,
The sensing unit includes a plurality of sensors selected from a dissolved oxygen sensor, a pH sensor, an inertial sensor, and a timer, and the control unit comprehensively evaluates and determines whether the material delivery device has reached a target organ. Oral mass delivery device, characterized in that. The method of claim 20,
Wherein the control unit evaluates the plurality of sensor signals with an AND condition to determine whether or not a target organ has been reached. The method of claim 20,
The control unit assigns a weight to each of the plurality of sensor signals, and quantitatively sums the weighted sensor signals to determine that the target organ has been reached when a predetermined criterion is exceeded. Mass transfer device. The method according to claim 1 or 2,
The driving unit and the material receiving unit are each disposed in a separate body from each other, and the combined body is an oral mass transfer device, characterized in that to maintain airtightness. The method according to claim 1 or 2,
Oral mass delivery device, characterized in that at least the material receiving portion maintains an environment from which oxygen has been removed. The method of claim 24,
Oral material delivery device, characterized in that the material receiving portion in a nitrogen environment.

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