CN210228872U - Gastrointestinal tract positioning switch and digestive tract fixed-point drug release capsule - Google Patents

Gastrointestinal tract positioning switch and digestive tract fixed-point drug release capsule Download PDF

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Publication number
CN210228872U
CN210228872U CN201822276054.7U CN201822276054U CN210228872U CN 210228872 U CN210228872 U CN 210228872U CN 201822276054 U CN201822276054 U CN 201822276054U CN 210228872 U CN210228872 U CN 210228872U
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electrode
gastrointestinal tract
capsule
positioning switch
drug release
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Xiaodong Duan
段晓东
Hongjiao Song
宋宏姣
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Ankon Medical Technologies Shanghai Ltd
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Ankon Medical Technologies Shanghai Ltd
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Abstract

The utility model provides a gastrointestinal tract positioning switch, it includes base member, first electrode, second electrode, electrically conductive device and location membrane, first electrode and second electrode interval set up and set firmly on the base member, and be connected with electrically conductive device on first electrode and the second electrode respectively, the location membrane cover first electrode with the second electrode, wherein, first electrode and second electrode are inert electrode, and in stomach or intestinal, the location membrane dissolves or/and degrades so that first electrode and second electrode expose. The utility model also provides a capsule for releasing the fixed-point medicine in the digestive tract. The utility model integrates two functions of positioning and triggering, and does not need to position the gastrointestinal tract by means of external large-scale instruments, so that the SSDC is simple to operate and use, and the autonomous medication of patients is realized; on the other hand, the space in the capsule is saved, sufficient space is provided for the release or/and sampling of the capsule, and the cost of the SSDC is reduced.

Description

Gastrointestinal tract positioning switch and digestive tract fixed-point drug release capsule
Technical Field
The utility model relates to a gastrointestinal tract location technical field, it is specific, relate to a gastrointestinal tract location switch and fixed point medicine release capsule of alimentary tract.
Background
At present, the chronic diseases of the gastrointestinal tract mostly need oral medicines for long-term treatment, but the medicines stay in the body for a short time and are greatly influenced by gastric acid, so that the medicines reaching the pathological change part are reduced, even can not reach the pathological change part, and the curative effect of the medicines is reduced. In addition, statistics shows that about 40% of new drug candidates are rejected because the new drug candidates have poor curative effects on human bodies, but the new drug candidates are poor in experimental methods in the early development process, and the absorption characteristics of the new drug candidates in different regions of the digestive tract cannot be accurately obtained. Therefore, how to increase the local therapeutic effect of the digestive tract and study the absorption characteristics of the drug in different regions of the digestive tract has become a key to the treatment of digestive tract diseases and the development of new drugs.
The Site-Specific drug release Capsule (SSDC) as a typical Micro-Electro-Mechanical-electronic System (MEMS) can provide an effective approach for solving the above problems. The SSDC can overcome discomfort and even trauma brought to patients by the traditional intubation and perfusion method, does not interfere with the normal physiological state of the digestive tract, and improves the effective rate and the accuracy of the local drug absorption research of new drugs and animal experiments. The localization of current SSDC in the digestive tract takes the following form:
firstly, the auxiliary device is used for assisting. For example, HF (high frequency) capsules developed by german hamman et al use X-ray transmission for gastrointestinal localization, with rf signals to trigger drug release; a fixed-point medicine release electronic capsule (trade name: Enterion TM) researched and developed by British Fiston Research corporation (Phaeton Research) utilizes a high-frequency magnetic field trigger control mechanism to monitor the position of a medicine by adopting a scintillation scanning method, and the medicine carrying amount is 0.8 mL. However, the method is not only complex in operation process and incapable of being used by patients, but also consumes large energy and has poor accuracy.
And secondly, judging the pH value of the gastrointestinal tract by using a pH (pH value) sensor. For example, SSDC developed at Chongqing university uses a pH sensor to detect the pH of the gastrointestinal tract, amplifies and filters the pH voltage signal, and transmits the signal to a microprocessor, which makes a decision to release the drug. However, the current pH sensor applied to the gastrointestinal tract mainly comprises a glass electrode, an antimony electrode and a hydrogen ion sensitive grid, wherein the glass electrode has large volume and is not easy to integrate into a capsule; the service life of the antimony electrode is limited, and the antimony electrode is easy to corrode; the hydrogen ion sensitive grid has poor stability and short service life.
SUMMERY OF THE UTILITY MODEL
In order to solve the technical problem, the utility model provides a gastrointestinal tract positioning switch and fixed point medicine release capsule of alimentary tract, this gastrointestinal tract positioning switch has integrated location and has triggered two kinds of functions, need not carry out gastrointestinal tract location with the help of outside large-scale instrument for SSDC becomes simple in operation and use, has realized that the patient independently uses medicine; on the other hand, the space in the capsule is saved, sufficient space is provided for the release or/and sampling of the capsule, and the cost of the SSDC is reduced.
The technical scheme of the utility model as follows:
the utility model provides a gastrointestinal tract positioning switch, includes base member, first electrode, second electrode, electrically conductive device and location membrane, first electrode with the second electrode interval sets up and sets firmly in on the base member, just first electrode with be connected with on the second electrode electricity respectively electrically conductive device, the location membrane covers first electrode with the second electrode, wherein, first electrode with the second electrode is the inert electrode, in stomach or intestinal, the location membrane dissolves or/and degrades so that first electrode with the second electrode exposes.
Preferably, the first electrode and the second electrode are both inert electrodes made of an inert conductive metal.
Preferably, the first electrode and the second electrode are formed by plating an inert conductive metal on the substrate by a sputter plating process.
Preferably, the conductive means is welded to the first and second electrodes.
Preferably, the conductive means is bonded to the first electrode and the second electrode by a conductive adhesive.
Preferably, the positioning film is formed by coating a film forming material on the first electrode and the second electrode by a spray coating or dip coating method.
Preferably, the matrix is made of acrylonitrile-butadiene-styrene copolymer.
Preferably, the conductive device includes a fixing portion fixed to the electrode, a contact portion electrically connectable, and a connecting portion connecting the fixing portion and the contact portion.
The utility model also provides a fixed point medicine release capsule of alimentary canal, it includes the capsule shell and locates medicine release or/and sampling device in the capsule shell, set firmly on the capsule shell as in any one above-mentioned gastrointestinal tract position switch, the electrically conductive device in the gastrointestinal tract position switch with medicine release or/and sampling device electricity are connected.
Preferably, the gastrointestinal tract positioning switch is embedded in the capsule shell.
The beneficial effects of the utility model reside in that: the gastrointestinal tract positioning switch comprises a substrate, a first electrode, a second electrode, a conducting device and a positioning film, wherein the first electrode and the second electrode are arranged at intervals and fixedly arranged on the substrate, the conducting device is electrically connected to the first electrode and the second electrode respectively, the first electrode and the second electrode are both inert electrodes, the positioning film covers the first electrode and the second electrode, when the positioning film reaches an environment required by dissolution or/and degradation of the positioning film, the positioning film is dissolved or/and degraded to expose the electrodes, and the exposed electrodes are contacted with digestive juice to form a loop so as to start a drug release or/and sampling function of the SSDC. Therefore, the gastrointestinal tract switch can be accurately controlled to be opened at different parts of the gastrointestinal tract through the selection of the positioning film, so that the drug release or/and sampling functions of the SSDC are triggered. Therefore, the gastrointestinal tract positioning is not needed by an external large instrument, so that the SSDC is simple to operate and use, and the autonomous administration of the patient is realized; on the other hand, the gastrointestinal tract positioning switch can not only save the space inside the capsule, provide sufficient space for the release or/and sampling of the capsule, but also reduce the cost of SSDC.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained without inventive work, wherein:
fig. 1 is a schematic structural diagram of a gastrointestinal tract positioning switch according to the present invention;
FIG. 2 is a schematic view of the gastrointestinal tract positioning switch of FIG. 1 at another angle;
FIG. 3 is a flow chart of a method of making the GI tract positioning switch of FIG. 1;
fig. 4 is a schematic structural diagram of the digestive tract site-specific drug release capsule of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative efforts belong to the protection scope of the present invention.
The utility model provides a gastrointestinal tract positioning switch 100, a manufacturing method of the gastrointestinal tract positioning switch 100 and a digestive tract fixed-point drug release capsule 200. The gastrointestinal tract positioning switch 100 is embedded in the capsule shell of the digestive tract fixed-point drug release capsule 200.
Referring to fig. 1 and fig. 2, the gastrointestinal tract positioning switch 100 includes a substrate 1, a first electrode 3, a second electrode 5, a conductive device 7, and a positioning film 9. The first electrode 3 with the second electrode 5 interval sets up and set firmly in on the base member 1, just first electrode 3 with be connected with on the second electrode 5 electricity respectively conducting device 7, location membrane 9 covers first electrode 3 with second electrode 5, first electrode 3 with second electrode 5 is inert electrode, in stomach or intestinal, location membrane 9 dissolves or/and degradation so that first electrode 3 with second electrode 5 exposes. The exposed first electrode 3 and the second electrode 5 are in contact with digestive juice in the stomach or intestinal tract to form a loop.
Wherein, the matrix 1 is made of material with good biocompatibility, for example, acrylonitrile-butadiene-styrene copolymer (also known as ABS resin); the first electrode 3 or/and the second electrode 5 may be an inert electrode made of an inert conductive metal, such as gold, platinum, silver, or the like, or an inert electrode made of an inert nonmetal, such as an electrode made of carbon; the conductive device 7 includes a fixing portion fixed to the electrode, a contact portion electrically connectable (e.g., electrically connected to the capsule 200), and a connecting portion connecting the fixing portion and the contact portion, for example, the conductive device 7 is a wire or a conductive slip ring.
The shape of the first electrode 3 or/and the second electrode 5 may be rectangular, square, circular, cross, arrow, flower, cross, or multi-fingered cross.
When the inert electrode is made of inert conductive metal, the conductive device 7 can be welded with the inert electrode or bonded with the inert electrode through conductive adhesive; when the inert electrode is made of non-metal, the conductive means 7 is bonded to the inert electrode by means of a conductive adhesive.
In the present embodiment, the first electrode 3 and the second electrode 5 are both inert electrodes made of inert conductive metal. That is, the first electrode 3 and the second electrode 5 may be welded to the conductive device 7, respectively, or the first electrode 3 and the second electrode 5 may be bonded to the conductive device 7 by conductive adhesive, respectively, or one of the first electrode 3 and the second electrode 5 may be bonded to the conductive device 7 by conductive adhesive and the other may be welded to the conductive device 7. In the present embodiment, the first electrode 3 and the second electrode 5 are electrically connected to the conductive device 7 in the same manner.
Further, the first electrode 3 and the second electrode 5 are formed by plating an inert conductive metal on the base 1 by a sputtering plating process.
Further preferably, the first electrode 3 and the second electrode 5 are formed by plating inert conductive metal on the substrate 1 through a magnetron sputtering plating process.
Because different regions of the gastrointestinal tract of a human body have special physiological parameters, such as pH value, the number of microorganisms and the like, certain high polymer materials can be dissolved or/and degraded in environments with different pH values, and natural polysaccharides can be degraded under the action of intestinal flora. Therefore, the positioning membrane 9 is made of a material that is soluble or/and degradable in the stomach or intestinal tract, so that the positioning membrane 9 is soluble or/and degradable in the stomach or intestinal tract.
The film-forming materials can be used in two types:
the first, pharmaceutic adjuvant acrylic resin refers to a kind of high molecular compound formed by polymerizing acrylic acid (or methacrylic acid and their esters such as methyl ester, ethyl ester, etc.) with a monomer, or copolymerizing with methacrylic acid (or its esters such as methyl ester, ethyl ester, dimethylamino ethyl ester, etc.) with two monomers (binary) or three monomers (ternary) according to a certain proportion. The compound is not degraded in vivo, is safe and nontoxic, can enable the drug to be designed in stomach or in intestine according to expectation due to the structural characteristics of the compound, and can prepare the drug into a targeted preparation. For example, butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate (1:2:1) copolymers can dissolve very quickly in media with a pH of less than 5 and have good film forming properties; the methacrylic acid and methyl methacrylate (1:1) copolymer can be dissolved in a solution with the pH value of more than 6, and has good film forming property; methacrylic acid and methyl methacrylate (1:2) copolymers are soluble in solutions having a pH greater than 7 and have good film forming properties.
Secondly, natural polysaccharides (such as chitosan, pectin, guar gum, etc.) can be degraded in specific colon-specific microorganisms, and have good film-forming properties.
The positioning film 9 is formed by coating a film forming material on the first electrode 3 and the second electrode 5 by a spray coating or dip coating method. This ensures that the first electrode 3 and the second electrode 5 are completely isolated from the outside in a parenteral or simulated gastrointestinal environment.
Referring to fig. 3, the method for manufacturing the gastrointestinal tract positioning switch includes the following steps:
step S1 is to form a first electrode 3 and a second electrode 5 on the substrate 1 such that the first electrode and the second electrode are spaced apart from each other. In the present embodiment, the first electrode 3 and the second electrode 5 are formed by plating an inert conductive metal (e.g., gold, platinum, silver, etc.) on the base 1 by a sputter plating process. Further preferably, the first electrode 3 and the second electrode 5 are formed by plating an inert conductive metal (e.g., gold, platinum, silver, etc.) on the substrate 1 by a magnetron sputtering plating process.
Step S2, electrically connecting conductive means 7 on the first electrode 3 and the second electrode 5, respectively. In this embodiment, the first electrode 3 and the second electrode 5 may be respectively welded to the conductive device 7, or the first electrode 3 and the second electrode 5 may be respectively bonded to the conductive device 7 by a conductive adhesive, or one of the first electrode 3 and the second electrode 5 may be bonded to the conductive device 7 by a conductive adhesive, and the other may be welded to the conductive device 7.
Step S3, fabricating a positioning film 9 on the first electrode 3 and the second electrode 5 to cover the first electrode 3 and the second electrode 5. In the present embodiment, the positioning film 9 is formed by coating a film forming material on the first electrode 3 and the second electrode 5 by a spray coating or dip coating method.
The utility model also provides a fixed point drug release capsule 200 for the digestive tract, which is shown in figure 4. The alimentary canal site-specific drug release capsule 200 comprises a capsule shell 300 and a drug release or/and sampling device (not shown in fig. 4) arranged in the capsule shell 300, wherein a gastrointestinal tract positioning switch 100 is fixedly arranged on the capsule shell, and a conductive device 7 in the gastrointestinal tract positioning switch 100 is electrically connected with the drug release or/and sampling device.
After the patient orally takes the alimentary canal site-specific drug release capsule 200 equipped with the gastrointestinal tract site-specific switch, the positioning film 9 in the gastrointestinal tract site-specific switch 100 is in full contact with a medium in the alimentary canal, after the positioning film 9 reaches a position where conditions required by dissolution or/and degradation of the positioning film are required, the positioning film 9 is dissolved or/and degraded to expose the first electrode 3 and the second electrode 5 in the alimentary canal medium, the exposed first electrode 3 and the exposed second electrode 5 are in contact with an alimentary canal to form a loop, so that a circuit of the drug release or/and sampling device is conducted, and the drug release function or/and the sampling function of the drug release device are started. Therefore, the gastrointestinal tract switch can be accurately controlled to be opened at different parts of the gastrointestinal tract through the selection of the positioning film 9, so that the drug release or/and sampling functions of the SSDC are triggered. Therefore, the gastrointestinal tract positioning is not needed by an external large instrument, so that the SSDC is simple to operate and use, and the autonomous administration of the patient is realized; on the other hand, the gastrointestinal tract localization switch 100 not only can save the space inside the capsule, provide sufficient space for drug release or/and sampling of the capsule, but also reduce the cost of the SSDC.
For example, a positioning membrane treated by butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate (1:2:1) copolymer is dissolved after reaching the stomach, so that the internal circuit of the digestive tract fixed-point drug release capsule is switched on to trigger the drug release; the positioning membrane treated by methacrylic acid and ethyl acrylate (1:1) copolymer is dissolved after reaching the small intestine part, and the drug release is triggered; the locating membrane treated by natural polysaccharide (chitosan, pectin, guar gum and the like) is degraded after reaching the colon part, and the release of the medicine is triggered; the localizing membrane treated with methacrylic acid, methyl acrylate and methyl methacrylate (1:1:1) copolymer dissolved upon reaching the colon triggering drug release.
In this embodiment, the gastrointestinal tract positioning switch 100 is embedded in the capsule housing.
The beneficial effects of the utility model reside in that: the gastrointestinal tract positioning switch 100 comprises a substrate 1, a first electrode 3, a second electrode 5, a conducting device 7 and a positioning film 9, wherein the first electrode 3 and the second electrode 5 are arranged at intervals and fixedly arranged on the substrate 1, the conducting device 7 is electrically connected to the first electrode 3 and the second electrode 5 respectively, the first electrode 3 and the second electrode 5 are inert electrodes, the positioning film 9 covers the first electrode 3 and the second electrode 5, when the positioning film reaches an environment required by dissolution or/and degradation of the positioning film, the positioning film is dissolved or/and degraded to expose the electrodes, and the exposed electrodes contact with digestive juice to form a loop to start a drug release or/and sampling function of the SSDC. Therefore, the gastrointestinal tract switch can be accurately controlled to be opened at different parts of the gastrointestinal tract through the selection of the positioning film, so that the drug release or/and sampling functions of the SSDC are triggered. Therefore, the gastrointestinal tract positioning is not needed by an external large instrument, so that the SSDC is simple to operate and use, and the autonomous administration of the patient is realized; on the other hand, the gastrointestinal tract positioning switch can not only save the space inside the capsule, provide sufficient space for the release or/and sampling of the capsule, but also reduce the cost of SSDC.
The above description is only a preferred embodiment of the present invention, and the present invention is not limited to the above description, and although the present invention has been disclosed with the preferred embodiment, it is not limited to the present invention, and any skilled person can make modifications or changes equivalent to the above embodiments without departing from the scope of the present invention, but all the modifications, equivalent changes and modifications made by the technical spirit of the present invention to the above embodiments are within the scope of the present invention.

Claims (10)

1. The utility model provides a gastrointestinal tract positioning switch, its characterized in that includes base member, first electrode, second electrode, electrically conductive device and location membrane, first electrode with the second electrode interval set up and set firmly in on the base member, just first electrode with be connected with on the second electrode electricity respectively electrically conductive device, the location membrane covers first electrode with the second electrode, wherein, first electrode with the second electrode is the inert electrode, in stomach or intestinal, the location membrane dissolves or/and degrades so that first electrode with the second electrode exposes.
2. The gastrointestinal tract positioning switch of claim 1, wherein the first electrode and the second electrode are both inert electrodes made of an inert conductive metal.
3. The gastrointestinal tract positioning switch of claim 2, wherein the first electrode and the second electrode are formed by plating an inert conductive metal on the substrate by a sputter coating process.
4. The gastrointestinal tract positioning switch of claim 2 or 3, wherein the conductive device is welded to the first electrode and the second electrode.
5. The gastrointestinal tract positioning switch according to any one of claims 1 to 3, wherein the conductive means is bonded to the first electrode and the second electrode by a conductive adhesive.
6. The gastrointestinal tract positioning switch according to claim 1, wherein the positioning film is formed by coating a film-forming material on the first electrode and the second electrode by a spraying or dip coating method.
7. The gastrointestinal positioning switch of claim 1, wherein the substrate is made of acrylonitrile-butadiene-styrene copolymer.
8. The gastrointestinal tract positioning switch of claim 1, wherein the conductive device comprises a fixing portion fixed to the electrode, a contact portion electrically connectable, and a connecting portion connecting the fixing portion and the contact portion.
9. An alimentary canal site-specific drug release capsule, comprising a capsule shell and a drug release or/and sampling device arranged in the capsule shell, characterized in that the gastrointestinal tract site-specific switch according to any one of claims 1-8 is fixedly arranged on the capsule shell, and a conductive device in the gastrointestinal tract site-specific switch is electrically connected with the drug release or/and sampling device.
10. The enteron site-specific drug release capsule of claim 9, wherein the gastrointestinal tract localization switch is embedded on the capsule housing.
CN201822276054.7U 2018-12-29 2018-12-29 Gastrointestinal tract positioning switch and digestive tract fixed-point drug release capsule Active CN210228872U (en)

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CN201822276054.7U CN210228872U (en) 2018-12-29 2018-12-29 Gastrointestinal tract positioning switch and digestive tract fixed-point drug release capsule

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109464742A (en) * 2018-12-29 2019-03-15 上海安翰医疗技术有限公司 Gastrointestinal tract position-sensing switch and preparation method thereof and alimentary canal site-specific drug release capsule

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109464742A (en) * 2018-12-29 2019-03-15 上海安翰医疗技术有限公司 Gastrointestinal tract position-sensing switch and preparation method thereof and alimentary canal site-specific drug release capsule

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