WO2023036296A1 - Drug administration capsule - Google Patents

Abstract

A drug administration capsule. The drug administration capsule is provided with a housing (1) with a drug cartridge (10), a soft capsule (11) arranged in the drug cartridge (10), a drug administration channel (2), and a drug administration control module (3). The drug administration control module (3) is used for filling the drug cartridge (10) with fluid to extrude the soft capsule (11), so that drug administration is carried out in a replacement manner. The drug administration control module can be used for controlling the drug administration amount by means of controlling the amount of fluid entering the drug cartridge (10), and the drug administration speed is controlled by means of controlling the speed of the fluid entering the drug cartridge (10).

Description

a drug capsule

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 "a drug delivery capsule", the entire contents of which are incorporated in this application by reference.

technical field

The invention relates to the technical field of medical devices, in particular to a drug delivery capsule.

Background technique

The controlled release of drugs can improve the therapeutic effect of drugs and reduce side effects, especially for difficult-to-reach digestive tract segments, the use of capsules has attracted more and more attention. It is non-destructive, painless, and has a wide coverage. Precise drug release and other advantages.

At present, there are already some capsule-type drug delivery device designs, such as InteliCap, which uses a micro-motor to convert rotational motion into linear motion through a transmission mechanism, thereby pushing the piston to push out the drug in the drug chamber. This design has a high release control capability: multiple doses can be carried out and the drug flow rate can be controlled. However, the device has a relatively complicated mechanical structure, high power consumption, and no camera function. It can only roughly distinguish the digestive tract interval through the pH sensor, and cannot perform more precise drug release, such as drug delivery in bleeding, ulcer and other lesion areas.

The paper "Therapeutic Capsule Endoscopy Opportunities and Challenges" discloses a capsule device that uses springs as the driving force for drug delivery. Under normal conditions, the spring is in a compressed state, fixed by a fusible wire, and the medicine compartment is filled with medicine. When the drug administration command is issued, the heating device blows the fusible link, the spring is released, and the piston is pushed to eject the drug. This kind of design structure is relatively simple, but it also has no camera function, so it cannot be administered accurately. At the same time, this solution can only be administered once, and the flow rate cannot be controlled. There are many similar designs, such as the design disclosed in Progenity's patent US2019282791A1.

Solutions based on micro-motors and magnetic drives are highly controllable, such as multiple doses and adjustable flow rates. However, their structures are generally complex and their drug loading capacity is small. The schemes based on springs, compressed air, chemical gas production reactions, etc. have relatively simple structures, but have low controllability and can only be administered once. At the same time, solutions such as compressed air and compressed springs have the problem of equipment failure due to material aging, such as slow spring release and air leakage.

In view of this, it is necessary to provide a highly controllable, safe and reliable drug delivery capsule.

Contents of the invention

The purpose of the present invention is to provide a drug delivery capsule to solve the deficiencies in the prior art. It is administered in a replacement manner, and the gas, liquid and other fluids outside the drug delivery capsule are pumped into the soft capsule through the drug delivery control module. The space of the medicine compartment is occupied in the medicine compartment, so that the medicine can be squeezed out from the soft capsule, and the control of administration can be realized conveniently.

The drug delivery capsule provided by the present invention has a shell of a medicine compartment, a soft capsule arranged in the medicine compartment, a drug delivery channel connecting the soft capsule with the outside of the shell, and a drug delivery control set in the shell. module; the administration control module is used to fill the medicine compartment with fluid to realize the extrusion of the soft capsule.

Further, the housing also has a device cavity and a partition separating the device cavity from the medicine compartment, the drug administration control module is arranged in the device cavity and includes a pump body, the inlet of the pump body It communicates with the outside of the casing, and the outlet of the pump body communicates with the drug storehouse.

Further, the drug delivery control module also has a pump inlet passage connecting the inlet of the pump body with the outside of the casing, and a filter unit arranged on the pump inlet passage.

Further, the filter unit is a plurality of air intake holes arranged on the housing, and the size of the air intake holes is smaller than the size of the inlet of the pump body, and the inlet pump channel also has a The connection channel between the air hole and the inlet of the pump body.

Further, the pump body is arranged on the partition, and the partition is provided with a connection hole connecting the medicine compartment and the equipment cavity, and the outlet of the pump body is connected to the connection hole.

Further, the drug delivery capsule also has an imaging module arranged in the cavity of the device, and the drug delivery channel includes a drug delivery outlet arranged on the housing; the drug delivery outlet is arranged on the imaging module. within the image acquisition area of the module.

Further, the drug delivery capsule is extended along the length direction, and the soft capsule and the imaging module are arranged on opposite sides of the housing in the length direction; the drug delivery outlet is arranged on the housing The side away from the soft capsule; the drug administration channel also has a drug inlet provided on the soft capsule and a connecting tube connecting the drug inlet and the drug outlet.

Further, the imaging module includes a camera arranged in the cavity of the device and a supplementary light arranged beside the camera.

Further, there is a magnetic unit in the cavity of the device.

Further, the shell is also provided with a medicine-filled soft rubber plug, and part of the medicine-filled soft rubber plug extends into the soft capsule.

Compared with the prior art, the present invention administers drugs in a replacement manner, and pumps gas, liquid and other fluids outside the drug capsule into the drug storehouse where the soft capsule is located through the drug delivery control module to occupy the space of the drug storehouse, thereby displacing The drug is extruded from the soft capsule; the drug administration control module can control the amount of fluid entering the drug compartment to control the amount of drug administration, and control the speed of fluid entering the drug compartment to achieve the speed of drug administration. And then realized the control of drug administration.

Description of drawings

Fig. 1 is a state diagram of the administration capsule disclosed in the embodiment of the present invention before administration;

Fig. 2 is a state diagram of the administration capsule disclosed in the embodiment of the present invention after administration;

Fig. 3 is a schematic diagram of the installation structure of the filter unit in the drug delivery capsule disclosed in the embodiment of the present invention;

Explanation of reference signs: 1-housing, 10-drug compartment, 11-soft capsule, 12-equipment cavity, 121-module accommodating cavity, 122-installation cavity, 13-partition, 14-first housing, 15-Second shell, 16-Air inlet, 17-Connecting channel, 18-Charging soft rubber plug, 2-Dosing channel, 21-Dosing outlet, 22-Dosing inlet, 23-Connecting pipe, 3 - Drug administration control module, 31 - pump body, 4 - control module, 41 - battery unit, 42 - electronic control unit, 5 - imaging module, 51 - module circuit board, 52 - camera, 53 - supplementary light.

Detailed ways

The embodiments described below by referring to the figures are exemplary only for explaining the present invention and should not be construed as limiting the present invention.

Embodiments of the present invention: a drug delivery capsule is disclosed. The drug delivery capsule has a drug storehouse for storing medicine. The drug stored in the drug storehouse enters the digestive tract section along with the drug delivery capsule. When it reaches the delivery area It is released after the lesion area, so as to achieve precise drug delivery.

Specifically, as shown in FIG. 1 , the drug delivery capsule disclosed in the present invention includes: a housing 1 having a medicine compartment 10 , a soft capsule 11 arranged in the medicine compartment 10 , and a capsule 11 communicating with the housing. 1 The external drug delivery channel 2 and the drug delivery control module 3 arranged in the housing 1; extrusion.

As shown in Figure 2, the soft capsule 11 is used to store medicine, and the shape of the soft capsule 11 can be changed, that is, the soft capsule 11 can be squeezed and compressed under the action of an external force, and can be compressed when the soft capsule 11 is squeezed and compressed by an external force. The drug stored in the soft capsule 11 is controlled to be released to the outside of the casing 1 through the drug delivery channel 2 , that is, to the drug delivery area/lesion area in the human body. It can be understood that the degree of release of the drug stored in the soft capsule 11 can be controlled by changing the compression degree of the soft capsule 11, and the source of the drug in the soft capsule 11 can also be controlled by changing the compression rate of the soft capsule 11. The release rate of the drug, the setting of the above structure facilitates the control of the drug release process.

It should be noted that the soft capsule 11 is made of biocompatible materials. In the initial state, the shape of the soft capsule 11 is not fixed, and when the drug is injected, the soft capsule 11 storing the drug fills the entire medicine compartment 10 . The connection between the soft capsule 11 and the administration channel 2 can be bonded by glue.

In order to realize the control of extrusion and compression of the soft capsule 11 conveniently, a drug administration control module 3 is provided in this embodiment. The drug administration control module 3 fills the medicine compartment 10 with fluid, and the fluid will occupy the medicine compartment 10 after filling the fluid. The space of the soft capsule 11 is further compressed, and the soft capsule 11 is squeezed, so that the medicine is released from the soft capsule 11 through the administration channel 2 . It can be understood that the fluid that the drug administration control module 3 fills into the medicine compartment 10 can be human digestive juice or other liquids in the human body, of course it can also be gas in the human body or a mixed fluid of gas and liquid.

In this embodiment, the medicine in the soft capsule 11 is not directly sucked by the pump, and then pumped out of the soft capsule 11. Instead, the drug storehouse 10 where the soft capsule 11 is located is occupied by fluids such as air and liquid from the outside by means of "replacement". Thereby the medicine is squeezed out from the soft capsule 11. The reason for this is that some medicines are highly viscous, or they are suspended liquids containing fine particles. If the pump body is used to pump directly from the soft capsule 11, the excessive viscosity of the liquid or the large particle size of the substance may cause the pump body to jam. die. 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.

The drug administration control module 3 can realize the control of the amount of drug administration by controlling the amount of fluid entering the medicine compartment 10, and then realize the control of the speed of drug administration by controlling the speed of the fluid entering the medicine compartment 10, thereby realizing drug administration. control.

In order to facilitate the control of the fluid entering the medicine compartment 10, the housing 1 also has a device cavity 12 and a partition 13 separating the device cavity 12 from the medicine compartment 10, and the drug administration control module 3 is set The device chamber 12 includes a pump body 31 , the inlet of the pump body 31 communicates with the outside of the casing, and the outlet of the pump body 31 communicates with the drug storehouse 10 .

The equipment cavity 12 is used to install the control components. The partition 13 separates the cavity inside the housing 1 into two parts: the equipment cavity 12 and the medicine compartment 10. In addition to storing the drug delivery control module 3, the equipment cavity 12 is also provided with a control unit. Module 4, the control module 4 includes a battery unit 41 and an electronic control unit 42, the electronic control unit 42 specifically includes a circuit board that controls the operation of the drug delivery control module 3, a microprocessor and a wireless device arranged on the circuit board Communication module, the battery unit 41 supplies power for the drug administration control module 3, the electronic control unit 42 and the wireless communication module, the wireless communication module is used to communicate with the control center outside the human body and receive instructions from the communication center, and microprocess after receiving the instructions The controller controls the drug delivery control module 3 to operate or close, and the specific microprocessor controls the stop or operation of the pump body 31 .

In this embodiment, the pump body 31 is a micropump, such as a pressurized pump, which has low power consumption, small size, safe use, long service life, controllable flow rate, and multiple drug releases. In a specific example, the parameters of the micropump used include: pump air pressure: 20KPa, pump water pressure: 100KPa, output flow: ≥2.5ml/min, power consumption: <50mW, volume (length×width×height): 7mm× 7mm×2mm.

In order to realize the connection between the pump body 31 and the electric control unit 42 conveniently, the installation and cooperation between the electric control unit 42 and the pump body 31 are realized through a plug-in assembly. The plug-in components can be small sockets and plugs that cooperate with each other and are connected by plug-in components. On the one hand, it is easy to assemble, and on the other hand, it will not affect the expansion research of other functions, that is, adding new functional modules can be processed and assembled separately.

Further, the device cavity 12 also has an imaging module 5, the imaging module 5 is electrically connected to the battery unit 41, and the imaging module 5 is used to obtain images or images of the drug capsule entering the human body, The imaging module 5 can be used to judge whether the drug delivery capsule has reached the designated digestive tract area, or the imaging module 5 can be used to identify the lesion area, and the release of the drug in the soft capsule 11 can be controlled after it is judged to reach the designated area or the lesion area is identified. The ability to visualize drug release enables more precise controlled release of drugs. For example, when treating peptic ulcer, the ulcer can be accurately found through the imaging module 5. When the drug delivery capsule is close to the surface of the ulcer, the drug release is controlled to spray the drug on the ulcer area, which facilitates the adhesion of gel drugs and improves the curative effect. .

Further, in order to facilitate the control of the movement of the drug delivery capsule in the digestive tract, there is also a magnetic unit (not shown) in the device cavity 12, the magnetic unit is arranged in the drug delivery capsule and can interact with an external magnetic field, The external magnetic field is used to control the movement of the drug delivery capsule in the human body, so as to better control the position of the drug delivery capsule in the human body.

It should be noted that the shell 1 is biocompatible and will not be corroded by digestive fluid, and can be set to be transparent or opaque as required. Since the imaging module 5 is provided, the part of the housing 1 corresponding to the image acquisition area of the imaging module 5 is transparent, so that the imaging module 5 can conveniently realize image acquisition. The image acquisition area of the imaging module 5 is the range and area of images that the imaging module 5 can capture.

In this embodiment, the imaging module 5 includes a module circuit board 51 arranged in the equipment cavity 12, a camera 52 arranged on the module circuit board 51, and a supplementary camera 52 arranged on the side of the camera 52. Light 53. The number of the supplementary lights 53 can be multiple, and the multiple supplementary lights 53 are arranged around the camera 52 . The module circuit board 51 is electrically connected to the battery unit 41 , and the battery unit 41 supplies power to the imaging module 5 .

The module circuit board 51 is adapted to the cross-sectional shape of the housing 1 , and the module circuit board 51 divides the equipment chamber 12 into two parts, which are respectively a module accommodating chamber 121 and an installation chamber 122 . The battery unit 41 and the drug delivery control module 3 are disposed in the installation cavity 122 , and the module accommodating cavity 121 is used for storing the imaging module 5 . The module accommodating cavity 121 is disposed on both sides of the installation cavity 122 opposite to the medicine compartment 10 .

It should be noted that the imaging module 5 may not have a module circuit board 51. In another embodiment, a partition is provided in the equipment cavity 12 to separate the equipment cavity 12 into two parts: the module accommodating cavity 121 and the installation cavity 122. , the imaging module 5 is disposed in the module accommodating cavity 121 . Both the camera 52 and the supplementary light 53 are directly installed and fixed on the separator and are electrically connected to the battery unit 41 respectively, while the camera 52 and the supplementary light 53 are also electrically connected to the electronic control unit 42 respectively.

In order to realize the installation and fixation of the imaging module 5 conveniently, the housing 1 generally includes a first housing 14 and a second housing 15, and the second housing 15 is detachably mounted and fixed on the first housing 14 , the installation cavity 122 is set in the first casing 14, the module accommodating cavity 121 is set in the second casing 15, and the second casing 15 and the module circuit board The module accommodating cavity 121 is formed between 51 . The second casing 15 has a hemispherical structure, and the second casing 15 is a transparent casing, so as to conveniently obtain images of the outside of the casing.

In this embodiment, the drug delivery control module 3 also has a pump inlet passage connecting the inlet of the pump body 31 with the outside of the housing 1 and a filter unit arranged on the pump inlet passage. The setting of the filter unit can filter the impurities in the fluid entering the pump body 31 , so as to prevent the impurities contained in the fluid from entering the pump body and causing the pump body to be stuck.

Specifically, as shown in Figures 2-3, the filter unit includes several air intake holes 16 arranged on the housing 1 (the air intake holes 16 are located at the entrance of the pump body 31), and the air intake holes The size of 16 is smaller than that of the inlet of the pump body 31 , and the pump inlet channel also has a connecting channel 17 connecting the inlet hole 16 with the inlet of the pump body 31 . Setting the size of the air inlet 16 to be smaller than that of the inlet of the pump body 31 can effectively prevent larger particles of impurities from entering the pump body 31 through the inlet of the pump body 31 , thereby causing blockage of the pump body 31 .

In this embodiment, in order to better save space, the pump body 31 is arranged on the partition 13, and the partition 13 is provided with a connection hole connecting the medicine compartment 10 and the equipment cavity 12 , the outlet of the pump body 31 communicates with the connecting hole. The outlet of the pump body 31 is directly exposed to the drug storehouse 10 to facilitate the release of the controlled fluid into the drug storehouse 10 .

The drug delivery channel 2 includes a drug delivery outlet 21 arranged on the casing 1 , and the drug delivery outlet 21 is arranged in the image acquisition area of the imaging module 5 . In this embodiment, the drug delivery outlet 21 is disposed on the second housing 15 .

In this embodiment, the drug delivery capsule is extended along the length direction, and the soft capsule 11 and the imaging module 5 are arranged oppositely on both sides of the housing 1 in the length direction; the drug delivery outlet 21 It is arranged on the side of the housing 1 away from the soft capsule 11; the administration channel 2 also has an administration inlet 22 arranged on the soft capsule 11 and communicates with the administration inlet 22 and the The connection pipe 23 of the drug delivery outlet 21, the connection pipe 23 is a hose. The hose can be made of biocompatible PC material. The drug delivery outlet 21 is arranged in the image acquisition area of the imaging module 5, so that the imaging module 5 can directly observe the drug delivery status, so as to better control the drug delivery.

It should be noted that the drug delivery outlet 21 is arranged on the housing 1 at a position away from the air inlet 16, so that the configuration of such a structure can prevent the drug coming out of the drug delivery outlet 21 from being inhaled directly from the air inlet 16, Therefore, it cannot act on the human body.

In addition, the pressure difference inside and outside the administration outlet 21 is constant, and the liquid in the digestive tract cannot directly enter the capsule through the administration outlet 21 . Even if the digestive juice outside the capsule may enter the connecting tube 23 from the drug delivery outlet 21, there is a certain amount of air in the connecting tube 23 after injection, and the connecting tube 23 is long enough to form an air column barrier. And the pressure difference inside and outside the capsule is fixed, so the digestive juice cannot enter the inside of the capsule.

In order to conveniently add medicine into the soft capsule 11 , the housing 1 is also provided with a drug-filled soft rubber plug 18 , and part of the drug-filled soft rubber plug 18 extends into the soft capsule 11 . The connection between the drug-filled soft rubber plug 18 and the soft capsule 11 can be bonded by glue. When loading medicine into the soft capsule 11, the needle of the syringe penetrates the drug-filled soft rubber plug 18 and finally extends into the soft capsule 11, injects the medicine from the syringe into the soft capsule 11, and loads the medicine after the needle of the syringe is pulled out The soft rubber stopper 18 has reset capability to block up the needle hole pierced by the syringe on the charge soft rubber stopper 18 again.

Before use, the user uses a syringe to pierce the drug-filled soft rubber plug 18, injects the drug into the soft capsule 11, and then swallows it for the patient. The drug capsule can be controlled by an external magnetic field to enter the designated area, and the imaging module 5 can judge Whether the drug delivery capsule has reached the designated area of the digestive tract or identified a lesion, after reaching the designated area of the digestive tract or identifying a focus, a drug release command can be sent to control the pump body 31 of the drug delivery capsule to work. The gas and liquid fluid in the digestive tract enter the inlet of the pump body 31 after being filtered by the filter unit, and then pumped into the medicine compartment 10 through the pump body 31 , and the fluid in the digestive tract squeezes the soft capsule 11 to make the medicine spray out through the administration outlet 21 .

It should be noted that the start, stop and flow rate of the pump body 31 can be controlled by the control module, and the micropump can be turned off and on at any time and the working frequency can be adjusted according to the needs, so as to achieve the purpose of multiple drug release and adjust the flow rate of the drug.

The structure, features and effects of the present invention have been described in detail above based on the embodiments shown in the drawings. The above descriptions are only preferred embodiments of the present invention, but the present invention does not limit the scope of implementation as shown in the drawings. Changes made to the idea of the present invention, or modifications to equivalent embodiments that are equivalent changes, and still within the spirit covered by the description and illustrations, shall be within the protection scope of the present invention.

Claims (10)

A drug delivery capsule, characterized in that it comprises: a housing with a drug compartment, a soft capsule arranged in the drug compartment, a drug delivery channel connecting the soft capsule with the outside of the housing, and a drug delivery channel arranged in the housing. The drug administration control module; the drug administration control module is used for filling fluid into the medicine compartment to realize the extrusion of the soft capsule. The drug delivery capsule according to claim 1, characterized in that: the housing also has a device cavity and a partition separating the device cavity from the medicine compartment, and the drug delivery control module is arranged in the device cavity It also includes a pump body, the inlet of the pump body communicates with the outside of the housing, and the outlet of the pump body communicates with the drug storehouse. The drug delivery capsule according to claim 2, characterized in that: the drug delivery control module also has an inlet pump channel connecting the inlet of the pump body with the outside of the casing and a filter unit arranged on the pump inlet channel . The drug delivery capsule according to claim 3, characterized in that: the filter unit is a plurality of air intake holes arranged on the housing, and the size of the air intake holes is smaller than the size of the inlet of the pump body , the pump inlet channel also has a connecting channel connecting the air inlet hole and the inlet of the pump body. The drug delivery capsule according to claim 2, characterized in that: the pump body is arranged on the partition, and the partition is provided with a connection hole connecting the medicine compartment and the device chamber, so The outlet of the pump body communicates with the connecting hole. The drug delivery capsule according to claim 2, characterized in that: the drug delivery capsule also has an imaging module arranged in the cavity of the device, and the drug delivery channel includes a drug delivery module arranged on the housing. Outlet; the drug delivery outlet is set in the image acquisition area of the imaging module. The drug delivery capsule according to claim 6, characterized in that: the drug delivery capsule is extended along the length direction, and the soft capsule and the imaging module are arranged oppositely on both sides of the housing in the length direction; The drug delivery outlet is arranged on the side of the housing away from the soft capsule; the drug delivery channel also has a drug delivery inlet arranged on the soft capsule and communicates with the drug delivery inlet and the drug delivery channel. Connecting tube for drug outlet. The drug delivery capsule according to claim 7, characterized in that: the imaging module includes a camera arranged in the cavity of the device and a supplementary light arranged on the side of the camera. The drug delivery capsule according to claim 2, characterized in that: there is also a magnetic unit in the cavity of the device. The drug delivery capsule according to claim 1, characterized in that: the shell is also provided with a drug-filled soft rubber plug, and part of the drug-filled soft rubber plug extends into the soft capsule.

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