Drug capsule

Abstract

The present invention discloses a dosing capsule, comprising a case having a drug container, a soft bag placed in the drug container, a drug-dosing passage, and a drug-dosing control module, the drug-dosing control module being for filling the drug container with fluid and realizing compression of the soft bag. The present invention dispenses by displacement, realizing control of the amount of drug by controlling the amount of fluid entering the drug container, and realizing control of the rate of drug by controlling the rate of fluid entering the drug container.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims the priority of a Chinese patent application with an application date of September 10, 2021, an application number of 202111060451.0, and an invention title of "Drug - delivery Capsule", and all of its contents are incorporated herein by reference. The present invention relates to the technical field of medical devices, and in particular, to drug - delivery capsules.

Background Art

[0002] Controlled release of drugs can enhance the therapeutic effect of drugs and reduce side effects. In particular, the drug - delivery means using capsules for hard - to - reach gastrointestinal tracts has advantages such as no loss, no pain, a wide coverage range, and precise drug - release control, and has attracted attention.

[0003] Currently, there are already several design schemes for capsule - type drug - delivery devices. For example, InteliCap uses a micromotor to convert rotational motion into linear motion by a transmission mechanism to push a piston and extrude the drug in the drug - containing part. Such a design has a high drug - release control ability to perform drug - delivery in multiple portions and control the drug flow rate. However, this device has a relatively complex mechanical structure, high power consumption, and no imaging function, and can only roughly distinguish gastrointestinal tracts by a pH sensor, and cannot achieve more precise drug release such as drug - delivery to lesion areas such as bleeding and ulcers.

[0004] The paper "Therapeutic Capsule Endoscopy Opportunities and Challenges" discloses a capsule device that uses a spring as the driving part for drug delivery. In the normal state, the spring is in a compressed state, fixed by a fuse, and the drug is contained in the drug storage part. When a drug delivery command is sent, the heating device melts the fuse, the spring is released, and the piston is pushed to discharge the drug. Such a design has a relatively simple structure, but at the same time, it does not have an imaging function and cannot accurately deliver drugs. At the same time, this solution can only perform batch drug delivery and cannot control the flow rate. There are many similar designs, such as the design disclosed in Progenity's patent US2019282791A1.

[0005] Solutions based on micromotors and magnetic drive, etc., have higher controllability. For example, multiple drug deliveries can be performed and the flow rate can be adjusted. However, these structures are generally complex and have a small carrying capacity. On the other hand, solutions based on springs, compressed air, chemical gas generation reactions, etc., have a relatively simple structure, but low controllability and can only perform batch drug delivery. At the same time, solutions such as compressed air and compressed springs both have problems that the device fails due to material degradation, such as the spring release being delayed or the gas leaking.

[0006] In view of the above, it is necessary to provide a drug delivery capsule with high controllability, safety and reliability.

Summary of the Invention

[0007] The purpose of the present invention is to provide a drug delivery capsule for solving the drawbacks in the prior art. The drug delivery capsule provided by the present invention delivers drugs by replacement, and fluid such as gas and liquid outside the drug delivery capsule is pumped into the drug storage part with a soft bag by a drug delivery control module to occupy the space of the drug storage part, so as to push the drug out of the soft bag and conveniently realize the control of drug delivery.

[0008] The dosing capsule provided by the present invention includes a case having a drug storage part, a soft bag placed in the drug storage part, a dosing passage communicating the soft bag with the outside of the case, and a dosing control module placed in the case. The dosing control module is for filling the drug storage part with a fluid to achieve compression of the soft bag.

[0009] Furthermore, the case further has a device chamber and a spacer partitioning the device chamber and the drug storage part. The dosing control module is placed in the device chamber. The dosing control module includes a pump body. The inlet of the pump body communicates with the outside of the case, and the outlet communicates with the drug storage part.

[0010] Furthermore, the dosing control module further has a pump inlet passage communicating the inlet of the pump body with the outside of the case, and a filtering unit provided in the pump inlet passage.

[0011] Furthermore, the filtering unit is a plurality of air intake holes provided in the case. The size of the air intake holes is smaller than the size of the inlet of the pump body. The pump inlet passage further has a connecting passage communicating the air intake holes with the inlet of the pump body.

[0012] Furthermore, the pump body is attached to the spacer. The spacer is provided with a connecting hole communicating the drug storage part and the device chamber. The outlet of the pump body communicates with the connecting hole.

[0013] Furthermore, the dosing capsule further has an imaging module arranged in the device chamber. The dosing passage includes a dosing outlet provided in the case. The dosing outlet is provided within the image acquisition region of the imaging module.

[0014] Furthermore, the dosing capsule extends along the longitudinal direction, and the soft bag and the imaging module are arranged on both sides of the case so as to face each other in the longitudinal direction. The dosing outlet is provided on a side of the case away from the soft bag, and the dosing passage further includes a dosing inlet provided in the soft bag and a connecting pipe that communicates the dosing inlet and the dosing outlet.

[0015] Furthermore, the imaging module includes a camera placed in the device chamber and a lighting lamp placed on the side of the camera.

[0016] Furthermore, it further has a magnetic unit arranged in the device chamber.

[0017] Furthermore, a rubber cap for loading medicine is attached to the case, and a part of the rubber cap for loading medicine extends into the soft bag.

[0018] Compared with the prior art, the present invention doses by replacement, and the dosing control module pumps fluids such as gas and liquid outside the dosing capsule into the drug storage part where the soft bag is located to occupy the space of the drug storage part, thereby extruding the drug from the soft bag. The dosing control module can realize the control of the dosing amount by controlling the amount of fluid entering the drug storage part, and realize the control of the dosing speed by controlling the speed of the fluid entering the drug storage part, and thereby realize the control of dosing.

Brief Description of the Drawings

[0019]

Figure 1

Figure 2

Figure 3

Modes for Carrying Out the Invention

[0020] The embodiments described below with reference to the drawings are exemplary only and are merely for interpreting the present invention and cannot be construed as limiting the present invention.

[0021] Embodiments of the present invention disclose a dosing capsule, and the dosing capsule has a drug storage part for storing drugs therein. The drug stored in the drug storage part enters the gastrointestinal tract section along with the dosing capsule and is released when it reaches the lesion area that becomes the dosing area, thereby realizing accurate dosing.

[0022] Specifically, as shown in FIG. 1, the dosing capsule disclosed in the present invention includes a case 1 having a drug storage part 10, a soft bag 11 placed in the drug storage part 10, a dosing passage 2 for communicating the soft bag 11 with the outside of the case 1, and a dosing control module 3 provided in the case 1. The dosing control module 3 is for filling the drug storage part 10 with fluid to realize the compression of the soft bag 11.

[0023] As shown in FIG. 2, the soft bag 11 is for storing drugs therein and its shape is variable. That is, the soft bag 11 can be pressed and compressed by an external force. When the soft bag 11 is pressed and compressed by an external force, the drug stored in the soft bag 11 can be controlled to be released to the outside of the case 1, that is, the dosing area / lesion area in the human body, through the dosing passage 2. In addition, by changing the degree of compression caused by the pressing of the soft bag 11, the release degree of the drug stored in the soft bag 11 can be controlled, and by changing the compression speed caused by the pressing of the soft bag 11, the release speed of the drug stored in the soft bag 11 can also be controlled. With the setting of the above structure, the control of the drug release process can be conveniently realized.

[0024] In addition, a material with biocompatibility is adopted for the soft bag 11. In the initial state, the form of the soft bag 11 is not constant. When the drug is injected, the soft bag 11 that accommodates the drug fills the entire drug accommodation part 10. The soft bag 11 and the dosing passage 2 may be connected by being adhered with an adhesive.

[0025] In order to conveniently realize the control of the pressing and compression of the soft bag 11, in this embodiment, a dosing control module 3 is provided. The dosing control module 3 fills the drug accommodation part 10 with a fluid, and the filled fluid occupies the space in the drug accommodation part 10. As a result, the space of the soft bag 11 is compressed, the soft bag 11 is pressed, and the drug is discharged from the soft bag 11 through the dosing passage 2. Note that the fluid filled by the dosing control module 3 into the drug accommodation part 10 may be the digestive juice of the human body or other liquids in the human body. Of course, it may also be the gas in the human body or a mixed fluid of gas and liquid.

[0026] In this embodiment, instead of directly sucking out the drug in the soft bag 11 by a pump and then pumping it out of the soft bag 11, by "replacement", the space of the drug accommodation part 10 where the soft bag 11 is located is occupied by a fluid such as external gas or liquid, so as to press the drug out of the soft bag 11. This is because if a drug with high viscosity or a suspension liquid containing fine particles is directly pumped out of the soft bag 11 by a pump body, the pump body may be clogged due to the too high viscosity of the liquid or the too large particle size of the substance. In the solution disclosed in this embodiment, the drug is avoided from flowing directly through the pump body, which improves the effectiveness of the device and the flexibility of drug use.

[0027] The dosing control module 3 can realize the control of the dosing amount by controlling the amount of the fluid entering the drug accommodation part 10, and can realize the control of the dosing speed by controlling the speed of the fluid entering the drug accommodation part 10, thereby realizing the control of the dosing.

[0028] To facilitate the control of the entry of fluid into the drug container 10, the case 1 further has a device chamber 12 inside and a spacer 13 that partitions the device chamber 12 and the drug container 10. The dosing control module 3 is placed inside the device chamber 12, and the dosing control module 3 includes a pump body 31. The inlet of the pump body 31 communicates with the outside of the case, and the outlet communicates with the drug container 10.

[0029] The device chamber 12 is for mounting a control set inside. The spacer 13 partitions the chamber inside the case 1 into two parts, namely the device chamber 12 and the drug container 10. Inside the device chamber 12, in addition to the dosing control module 3, a control module 4 is placed. The control module 4 includes a battery unit 41 and an electrical control unit 42. Specifically, the electrical control unit 42 includes a circuit board for controlling the operation of the dosing control module 3, and a microprocessor and a wireless communication module mounted on the circuit board. The battery unit 41 supplies power to the dosing control module 3, the electrical control unit 42, and the wireless communication module. The wireless communication module is used to communicate with a control center outside the human body and receive commands from the communication center. When a command is received, the microprocessor controls the dosing control module 3 to be turned on or off. Specifically, the microprocessor controls the stop or operation of the pump body 31.

[0030] In this embodiment, the pump body 31 is a micropump such as a pressure pump. The pressure pump has low power consumption, a small volume, use safety, a long service life, a controllable flow rate, and can release drugs multiple times. In one specific example, the parameters of the micropump adopted include a pump air pressure of 20 KPa, a pump water pressure of 100 KPa, an output flow rate ≥ 2.5 ml / min, a power consumption < 50 mW, and a volume (length × width × height) of 7 mm × 7 mm × 2 mm.

[0031] To facilitate the connection between the pump body 31 and the electric control unit 42, the connection between the electric control unit 42 and the pump body 31 is realized by a socket plug set. The socket plug set may be a combination of a small socket and a plug. The connection using the socket plug set is convenient for installation and placement, and does not affect the research on the expansion of other functions. That is, any newly added functional modules can be processed independently and then incorporated.

[0032] Furthermore, an imaging module 5 is disposed inside the device chamber 12. The imaging module 5 is electrically connected to the battery unit 41 and is for acquiring an image or video after the dosing capsule enters the human body. The imaging module 5 can determine whether the dosing capsule has reached a specific gastrointestinal region, or can recognize a lesion region. When it is determined that the dosing capsule has reached a specific region or when a lesion region is recognized, the drug in the soft bag 11 is controlled to be released, having the ability to visualize drug release and enabling more accurate control of drug release. For example, in the case of treating a gastrointestinal ulcer, the imaging module 5 can accurately detect the ulcer. When the dosing capsule is close to the surface of the ulcer, the drug release can be controlled so that the drug is discharged into the ulcer region, thereby contributing to the adhesion of gel drugs and enhancing the therapeutic effect.

[0033] Furthermore, to conveniently control the movement of the dosing capsule in the gastrointestinal tract, a magnetic unit (not shown) is disposed inside the device chamber 12. The magnetic unit is placed inside the dosing capsule and can interact with an external magnetic field. By controlling the movement of the dosing capsule in the human body by the external magnetic field, the position of the dosing capsule in the human body can be better controlled.

[0034] Note that the case 1 has biocompatibility and is not corroded by digestive juices, and may be made transparent or opaque as required. Since the imaging module 5 is provided, a part of the case 1 corresponding to the image acquisition area of the imaging module 5 is made transparent for image acquisition by the imaging module 5. The image acquisition area of the imaging module 5 is the range and area of an image that the imaging module 5 can capture.

[0035] In this embodiment, the imaging module 5 includes a module circuit board 51 placed in the device chamber 12, a camera 52 attached to the module circuit board 51, and an illumination lamp 53 placed on the side of the camera 52. The number of the illumination lamps 53 may be plural, and the plural illumination lamps 53 are arranged to surround the camera 52. The module circuit board 51 and the battery unit 41 are electrically connected, and the battery unit 41 supplies power to the imaging module 5.

[0036] The module circuit board 51 corresponds to the shape of the cross-section of the case 1 and partitions the device chamber 12 into two parts, a module accommodation chamber 121 and a mounting chamber 122. The battery unit 41 and the dosing control module 3 are placed in the mounting chamber 122, and the module accommodation chamber 121 is for accommodating the imaging module 5 therein. The module accommodation chamber 121 and the drug accommodation part 10 are provided on both sides of the mounting chamber 122 so as to face each other.

[0037] Note that the imaging module 5 may not be provided with the module circuit board 51. In other embodiments, a partition plate is provided in the device chamber 12 so as to partition the device chamber 12 into two parts, a module accommodation chamber 121 and a mounting chamber 122, and the imaging module 5 is placed in the module accommodation chamber 121. Then, both the camera 52 and the illumination lamp 53 are directly fixed to the partition plate, and are respectively electrically connected to the battery unit 41 and further electrically connected to the electric control unit 42.

[0038] In order to conveniently realize the attachment and fixation of the imaging module 5, the case 1 generally includes a first case 14 and a second case 15. The second case 15 is detachably attached and fixed to the first case 14. The attachment chamber 122 is provided in the first case 14, and the module accommodation chamber 121 is provided in the second case 15. The module accommodation chamber 121 is formed between the second case 15 and the module circuit board 51. The second case 15 has a dome-shaped structure and is a transparent case for acquiring an image outside the case.

[0039] In this embodiment, the dosing control module 3 further has a pump inlet passage that communicates the inlet of the pump body 31 with the outside of the case 1, and a filtering unit provided in the pump inlet passage. By providing the filtering unit, impurities mixed in the fluid can be filtered from the fluid entering the pump body 31 so as to avoid blockage of the pump body caused by the impurities entering the pump body.

[0040] Specifically, as shown in FIGS. 2 to 3, the filtering unit includes a plurality of intake holes 16 provided in the case 1, and the plurality of intake holes 16 are located at the inlet of the pump body 31. The size of the intake holes 16 is smaller than the size of the inlet of the pump body 31, and the pump inlet passage further has a connection passage 17 that communicates the intake holes 16 with the inlet of the pump body 31. By making the size of the intake holes 16 smaller than the size of the inlet of the pump body 31, blockage of the pump body 31 caused by large-sized impurities entering the pump body 31 from the inlet of the pump body 31 can be effectively prevented.

[0041] In this embodiment, in order to better save space, the pump body 31 is attached to the spacer 13. The spacer 13 is provided with a connection hole for communicating the drug storage portion 10 and the device chamber 12, and the outlet of the pump body 31 communicates with the connection hole. By directly exposing the outlet of the pump body 31 to the drug storage portion 10, it is convenient to realize the control of the release of the fluid into the drug storage portion 10.

[0042] The dosing passage 2 includes a dosing outlet 21 provided in the case 1, and the dosing outlet 21 is provided within the image acquisition region of the imaging module 5. In this embodiment, the dosing outlet 21 is provided in the second case 15.

[0043] In this embodiment, the dosing capsule extends along the longitudinal direction, and the soft bag 11 and the imaging module 5 are arranged on both sides of the case 1 so as to face each other in the longitudinal direction. The dosing outlet 21 is provided on the side of the case 1 away from the soft bag 11. The dosing passage 2 further has a dosing inlet 22 provided in the soft bag 11 and a connecting pipe 23 for communicating the dosing inlet 22 and the dosing outlet 21, and the connecting pipe 23 is a hose. A PC material having biocompatibility may be adopted for the hose. By providing the dosing outlet 21 in the image acquisition region of the imaging module 5 so that the dosing situation can be directly observed by the imaging module 5, better control of dosing can be realized.

[0044] Note that the dosing outlet 21 is provided at a position away from the intake hole 16 in the case 1. With such a structure, it is possible to avoid the drug discharged from the dosing outlet 21 being directly absorbed by the intake hole 16 and unable to act on the human body.

[0045] In addition, the pressure difference between the inside and outside of the drug delivery outlet 21 is made constant, and the liquid in the digestive tract cannot directly enter the inside of the capsule from the drug delivery outlet 21. Even if there is a slight possibility that the digestive fluid outside the capsule enters the connecting tube 23 from the drug delivery outlet 21, after the drug is injected, a certain amount of air exists in the connecting tube 23, and the connecting tube 23 is sufficiently long to form a blocking air column, and since the pressure difference between the inside and outside of the capsule is constant, the digestive fluid does not enter the inside of the capsule.

[0046] To conveniently realize the addition of the drug into the soft bag 11, a rubber cap 18 for drug loading is attached to the case 1, and a part of the rubber cap 18 for drug loading extends into the soft bag 11. The connection between the rubber cap 18 for drug loading and the soft bag 11 may be realized by adhesion with an adhesive. When loading the drug into the soft bag 11, the needle of the syringe is pierced into the rubber cap 18 for drug loading and finally extended into the soft bag 11, so as to inject the drug from the syringe into the soft bag 11. Since the rubber cap 18 for drug loading has a restoring ability, when the needle of the syringe is withdrawn, the hole pierced by the needle of the syringe in the rubber cap 18 for drug loading will be blocked again.

[0047] Before use, the user pierces the syringe into the rubber cap 18 for drug loading, injects the drug into the soft bag 11, and then lets the patient drink the soft bag 11. The external magnetic field can be used to control the drug delivery capsule to enter a specific area, and the imaging module 5 determines whether the drug delivery capsule has reached a specific digestive tract area or recognized a lesion. When the soft bag 11 reaches a specific area of the digestive tract or recognizes a lesion, a drug release command is sent, and the operation of the pump body 31 of the drug delivery capsule can be controlled. The gas and liquid fluid in the digestive tract enter the inlet of the pump body 31 through the filtration of the filtration unit, and are further pumped into the drug storage part 10 by the pump body 31, pressing the soft bag 11 to discharge the drug through the drug delivery outlet 21.

[0048] Note that the startup, stop, and flow rate of the pump body 31 can all be controlled by the control module. According to demand, the micropump can be turned on and off at any time, and the operation frequency can be adjusted. Thereby, the purposes of multiple drug releases and adjustment of the drug flow rate are achieved.

[0049] As described above, the structure, features, and effects of the present invention have been described in detail with reference to the embodiments shown in the drawings. However, what has been described above is merely a preferred embodiment of the present invention. The scope of implementation of the present invention is not limited by what is shown in the drawings. Equivalent embodiments modified according to the concept of the present invention or equivalent changes should all be included in the protection scope of the present invention as long as they do not still exceed the spirit included by the specification and the drawings.

Explanation of Reference Numerals

[0050] 1... Case, 10... Drug storage part, 11... Soft bag, 12... Device chamber, 121... Module storage chamber, 122... Mounting chamber, 13... Spacer, 14... First case, 15... Second case, 16... Intake hole, 17... Connection passage, 18... Rubber cap for drug loading, 2... Medication passage, 21... Medication outlet, 22... Medication inlet, 23... Connecting tube, 3... Medication control module, 31... Pump body, 4... Control module, 41... Battery unit, 42... Electric control unit, 5... Imaging module, 51... Module circuit board, 52... Camera, 53... Lighting lamp

Claims

1. A dosing capsule comprising a case having a drug storage part, a soft bag placed in the drug storage part, a dosing passage communicating the soft bag with the outside of the case, and a dosing control module placed in the case, wherein the dosing control module is for filling a fluid into the drug storage part to achieve compression of the soft bag, and the dosing control module fills an external fluid into the drug storage part, the filled fluid occupies the space of the drug storage part, whereby the space of the soft bag is compressed, the soft bag is compressed, and drugs are released from the soft bag through the dosing passage.

2. The dosing capsule according to claim 1, further comprising a device chamber and a spacer partitioning the device chamber and the drug storage part in the case, wherein the dosing control module is placed in the device chamber, the dosing control module includes a pump body, and an inlet of the pump body communicates with the outside of the case and an outlet thereof communicates with the drug storage part.

3. The dosing capsule according to claim 2, wherein the dosing control module further comprises a pump inlet passage communicating the inlet of the pump body with the outside of the case and a filtration unit provided in the pump inlet passage.

4. The dosing capsule according to claim 3, wherein the filtration unit is a plurality of air intake holes provided in the case, a size of the air intake holes is smaller than a size of the inlet of the pump body, and the pump inlet passage further comprises a connection passage communicating the air intake holes with the inlet of the pump body.

5. The dosing capsule according to claim 2, wherein the pump body is attached to the spacer, the spacer is provided with a connection hole communicating the drug storage part and the device chamber, and the outlet of the pump body communicates with the connection hole.

6. The dosing capsule further has an imaging module disposed in the device chamber, the dosing passage includes a dosing outlet provided in the case, and the dosing outlet is provided within an image acquisition region of the imaging module. The dosing capsule according to claim 2 is characterized in that.

7. The dosing capsule extends along the longitudinal direction, the soft bag and the imaging module are disposed on both sides of the case so as to face each other in the longitudinal direction, the dosing outlet is provided on a side of the case away from the soft bag, and the dosing passage further has a dosing inlet provided in the soft bag and a connecting pipe that communicates the dosing inlet and the dosing outlet. The dosing capsule according to claim 6 is characterized in that.

8. The imaging module includes a camera disposed in the device chamber and an illumination lamp disposed beside the camera. The dosing capsule according to claim 7 is characterized in that.

9. The dosing capsule according to claim 2 further has a magnetic unit disposed in the device chamber.

10. A rubber cap for loading medicine is attached to the case, and a part of the rubber cap for loading medicine extends into the soft bag. The dosing capsule according to claim 1 is characterized in that.

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