Release balloon core for distal end release of digestive tract cannula, preparation method therefor and use thereof

Abstract

The present disclosure relates to the technical field of medical instruments, and provides a release balloon core for distal end release of a digestive tract cannula, a preparation method therefor and a use thereof. The release balloon core comprises a filler, an adhesive and a disintegrating agent in a mass ratio of (50-90):(10-50):(0-20). The filler comprises at least one of starch, microcrystalline cellulose and inorganic salt. The adhesive comprises at least one of water, ethanol, hydroxypropyl methylcellulose, carboxymethyl cellulose or salt thereof, methylcellulose and syrup. By means of the peristalsis of the digestive tract and the gravity effect of the release balloon, a cannula body is driven to move in the digestive tract until the cannula is completely expanded, and when the cannula body has finished self-expansion, the release balloon core is separated from the cannula body by controlling the composition of the release balloon core, so that an implantation operation of the digestive tract cannula is completed. The method is simple and convenient to operate, the time for implanting the digestive tract cannula is greatly shortened, and the infection risk and the ray radiation hazard are reduced.

Description

Release ball inner core for distal release of digestive tract cannula and preparation method and application thereof

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims priority to application number 202311152577X filed with the China Patent Office on September 7, 2023, entitled “Release ball core for distal release of digestive tract sleeve and its preparation method and application”, the entire contents of which are incorporated into this disclosure by reference. Technical Field

[0003] The present disclosure relates to the technical field of medical devices, and in particular to a release ball inner core for distal release of a digestive tract sleeve, and a preparation method and application thereof. Background Art

[0004] As our understanding of obesity deepens and develops, we realize that obesity is not simply weight gain, but rather a syndrome associated with a range of chronic diseases, including type 2 diabetes, hypertension, sleep apnea, and polycystic ovary syndrome. Overweight and obesity increase the risk of a variety of chronic diseases in adults. They can not only lead to serious cardiovascular and cerebrovascular diseases or endocrine and metabolic disorders, but can also cause respiratory, digestive, or motor system disorders and are associated with the development of various malignant tumors. Furthermore, obesity has become a significant factor affecting people's mental health and social interactions, and has led to an increased economic burden. The prevalence of obesity-related chronic diseases in China is severe.

[0005] According to WHO standards, BMI ≥ 30 kg / m 2Using the obesity cutoff as the threshold, the prevalence of adult obesity in China increased nearly eightfold from 1980 to 2015. The "Beijing Primary and Secondary School Students' Nutrition and Health Status Report (2017)" shows that in 2017, the overweight rate among monitored students in Beijing was 15.9%, the obesity rate was 16.9%, and the overweight and obesity rate had reached 32.8%, which is consistent with the level in the United States. Over the past 20 years, both overweight and obesity rates in China have increased significantly, exceeding those of several developed countries. Currently, the main treatments for obesity include diet, exercise, and behavioral interventions, medication, or bariatric surgery. Due to their long duration, adherence is difficult, and diet, exercise, and behavioral interventions only achieve a weight loss effect of 3-5%. Although weight loss medications can provide additional weight loss benefits, data from US electronic medical records show that prescription rates and continued use of these medications are low due to their side effects. Bariatric surgery is highly effective in all of these conditions, but it carries irreversible physiological changes and a certain mortality rate. Postoperative complications, such as gastrointestinal leakage, anastomotic stenosis, and dumping syndrome, are also associated with these conditions. In recent years, drawing on the principles of gastric bypass surgery in weight loss surgery, a sleeve has been inserted into the duodenum-jejunum segment to isolate the contact between chyme and the intestine to reduce intestinal absorption, thereby achieving weight loss, which has aroused widespread research interest among scholars.

[0006] CN109152570 discloses a method for endoscopic cannula insertion. However, this method requires manual operation to connect the distal end of the cannula to the distal cap, and requires injecting liquid into the cannula to smoothly extend and shape the cannula within the digestive tract. This method is complex to operate, takes a long time to insert the cannula, and requires X-ray operation, which greatly increases the risk of infection and radiation hazards. Therefore, a new method for releasing a digestive tract cannula is urgently needed to address the above problems.

[0007] In view of this, the present disclosure is proposed.

[0008] Summary of the Invention

[0009] The purpose of the present disclosure is to provide a release ball inner core for distal release of a digestive tract sleeve and its preparation method and application, which can self-expand in the digestive tract, is simple and convenient to operate, and greatly shortens the insertion operation time of the digestive tract sleeve.

[0010] The embodiments of the present disclosure are implemented as follows:

[0011] In a first aspect, the present disclosure provides a release ball inner core for distal release of a digestive tract sleeve, comprising a filler, a binder, and a disintegrant in a mass ratio of 50-90:10-50:0-20.

[0012] The filler includes at least one of starch, microcrystalline cellulose and inorganic salts.

[0013] The binder includes at least one of water, ethanol, hypromellose, carboxymethylcellulose or a salt thereof, methylcellulose and syrup.

[0014] In an alternative embodiment, the inorganic salt includes at least one of calcium sulfate, calcium hydrogen phosphate, calcium carbonate, and barium sulfate.

[0015] Preferably, the barium sulfate is any one of heavy barium sulfate, type I barium sulfate and type II barium sulfate.

[0016] More preferably, the barium sulfate is heavy barium sulfate or type II barium sulfate.

[0017] In an alternative embodiment, the filler comprises any one of the following two combinations: microcrystalline cellulose and calcium carbonate or microcrystalline cellulose and barium sulfate; preferably microcrystalline cellulose and barium sulfate.

[0018] Preferably, the mass ratio of the filler to the binder is 56.2-86.9:13.1-42.2.

[0019] In an alternative embodiment, the disintegrant comprises at least one of cross-linked sodium carboxymethyl starch, cross-linked polyvinyl pyrrolidone, cross-linked sodium carboxymethyl cellulose, and sodium chloride.

[0020] In an optional embodiment, auxiliary materials are further included, and the mass ratio of the filler to the auxiliary materials is 50-90:0.01-5.

[0021] Preferably, the auxiliary material includes at least one of an antioxidant, a preservative and a fragrance.

[0022] In a second aspect, the present disclosure provides a method for preparing the inner core of a release ball for distal release of a digestive tract sleeve as described in any of the aforementioned embodiments, comprising mixing the raw materials in proportion and then tableting, wherein the tableting method comprises any one of wet granulation tableting, direct tableting and molding.

[0023] Preferably, the tableting method is wet granulation tableting or molding method; more preferably, wet granulation tableting.

[0024] In a third aspect, the present disclosure provides a digestive tract sleeve, comprising a sleeve body and a release ball core for releasing the distal end of the digestive tract sleeve as described in any of the aforementioned embodiments, wherein the release ball core is fixed in a release ball having an inner cavity, and the sleeve body comprises a proximal end and a distal end, wherein the distal end is connected to the release ball core.

[0025] In an optional embodiment, the dry connection force between the inner core of the release ball and the distal end of the digestive tract sleeve is greater than 2.5N, preferably greater than 5N.

[0026] Preferably, the wet connection force between the inner core of the release ball and the distal end of the digestive tract sleeve is less than 1.5N after being kept in the wet state for 2 hours; more preferably, less than 1N.

[0027] In a fourth aspect, the present disclosure provides a release ball core for distal release of a digestive tract sleeve as in any of the aforementioned embodiments, or use of the digestive tract sleeve as in the aforementioned embodiments in preparing a product that reduces gastrointestinal absorption.

[0028] The beneficial effects of the embodiments of the present disclosure are:

[0029] The present disclosure provides a release ball inner core for the distal release of a digestive tract cannula, and its preparation method and application. During the release process, the cannula is extended by means of the natural peristalsis of the intestine. By controlling the composition of the release ball inner core, when fully expanded, it disintegrates with the help of the mucus at the distal end of the intestine, loses its structure and mechanical properties, and the connection between the cannula and the release ball inner core is disconnected. The entire process does not require other additional operations by medical staff. The operation method is simple, greatly shortens the time for the insertion of the digestive tract cannula, and reduces the risk of infection and the hazards of X-ray radiation. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present disclosure and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0031] FIG1 is a schematic structural diagram of a digestive tract cannula provided by the present disclosure;

[0032] FIG2 is a schematic diagram of the delivery process of the digestive tract sleeve provided by the present disclosure;

[0033] FIG3 is a digital gastrointestinal angiography image 4 hours after the release of the digestive tract sleeve provided in Experimental Example 2 of the present disclosure.

[0034] Illustration: 100 - digestive tract cannula; 110 - cannula body; 120 - release ball. DETAILED DESCRIPTION

[0035] The embodiments of the present disclosure will be described in detail below with reference to the examples. However, those skilled in the art will appreciate that the following examples are intended only to illustrate the present disclosure and should not be construed as limiting the scope of the present disclosure. Where specific conditions are not specified in the examples, the experiments were performed under conventional conditions or the conditions recommended by the manufacturer. Where the manufacturer of the reagents or instruments is not specified, all are commercially available conventional products.

[0036] The endpoints of the ranges and any values ​​disclosed in this disclosure are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoints of each range, the endpoints of each range and individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, and these numerical ranges should be considered to be specifically disclosed herein.

[0037] The present disclosure provides a release ball inner core for distal release of a digestive tract sleeve, comprising a filler, a binder and a disintegrant in a mass ratio of 50-90:10-50:0-20.

[0038] The filler includes at least one of starch, microcrystalline cellulose and inorganic salts.

[0039] The binder includes at least one of water, ethanol, hypromellose, carboxymethylcellulose or a salt thereof, methylcellulose and syrup.

[0040] At present, the insertion process of the digestive tract cannula mostly adopts the method of injecting fluid to stretch the cannula, but the process of injecting fluid and waiting for the cannula to stretch is long, which prolongs the insertion operation time of the digestive tract cannula and increases the difficulty of operation. Therefore, the inventor creatively proposed to set a release ball inner core on the digestive tract cannula. The particle can drive the cannula body to self-expand in the digestive tract by its own weight. Therefore, the digestive tract cannula can be directly built in without waiting for a long time for the cannula to fully stretch, which is easier to operate. However, since the release ball inner core needs to be sterilized before it can be put into use, ethylene oxide and other substances are generally used to sterilize the release ball inner core. The disintegration effect of conventional sustained-release structures or disintegrating particles changes significantly after sterilization.

[0041] For example, a product that previously disintegrated in about two hours still failed to disintegrate 24 hours after ethylene oxide sterilization. Therefore, ensuring that the release pellet core maintains good disintegration properties after sterilization is crucial for this product's success in achieving the aforementioned goal of "no need to wait for the sleeve to fully expand, resulting in easier operation."

[0042] The inventors proposed a method of compounding fillers, adhesives and disintegrants, and screened the raw material composition and ratio, so that the prepared release ball core can ensure that it still maintains better disintegration performance after sterilization. The disintegration effect disclosed in the present invention mainly includes two aspects. One is that the capillary action promotes disintegration: the release ball core has many capillaries and pores. After contact with water, water enters the interior of the release ball core from these hydrophilic channels. The strong water absorption makes the release ball core lubricated and disintegrated. The disintegration effect of cellulose derivatives is mostly related to this. The other is the erosion effect: when the release ball core encounters intestinal fluid in the duodenum, the soluble components in the release ball core, such as disintegrants, dissolve when encountering water, forming erosion holes, which break the core into small particles, and form "holes" after dissolution, accelerating disintegration.

[0043] In an alternative embodiment, the inorganic salt includes at least one of calcium sulfate, calcium hydrogen phosphate, calcium carbonate, and barium sulfate.

[0044] Preferably, the barium sulfate is any one of heavy barium sulfate, type I barium sulfate, and type II barium sulfate. Barium sulfate has visualization capabilities. Therefore, when barium sulfate is selected as the filler, the release sphere core provided by the present disclosure has visualization capabilities. When inserted into the digestive tract, its position within the digestive tract can be better observed to determine whether the digestive tract cannula is properly positioned.

[0045] More preferably, the barium sulfate is heavy barium sulfate or type II barium sulfate.

[0046] In an alternative embodiment, the filler comprises any one of the following two combinations: microcrystalline cellulose and calcium carbonate or microcrystalline cellulose and barium sulfate; preferably microcrystalline cellulose and barium sulfate.

[0047] Preferably, the mass ratio of the filler to the binder is 56.2-86.9:13.1-42.2.

[0048] In an optional embodiment, in order to further control the separation time of the release pellet core and the sleeve body, the mass ratio of the filler, the binder and the disintegrant is 50-90:10-50:0.01-20.

[0049] Preferably, the mass ratio of the filler, the binder and the disintegrant is 56.2-86.9:13.1-42.2:0.01-15.6.

[0050] Preferably, the disintegrant comprises at least one of cross-linked sodium carboxymethyl starch, cross-linked polyvinyl pyrrolidone, cross-linked sodium carboxymethyl cellulose and sodium chloride.

[0051] In an optional embodiment, the mass ratio of filler, binder, disintegrant and excipient is 50-90:10-50:0-20:0.01-5.

[0052] Preferably, the mass ratio of filler, binder, disintegrant and excipient is 56.2-86.9:13.1-42.2:0.01-15.6:0.01-3.

[0053] Preferably, the auxiliary material includes at least one of an antioxidant, a preservative and a fragrance.

[0054] In a second aspect, the present disclosure provides a method for preparing the inner core of a release ball for distal release of a digestive tract sleeve as described in any of the aforementioned embodiments, comprising mixing the raw materials in proportion and then tableting, wherein the tableting method comprises any one of wet granulation tableting, direct tableting and molding.

[0055] Preferably, the tableting method is wet granulation tableting or molding method; more preferably, wet granulation tableting method. The specific method can be processed by referring to the existing tableting methods.

[0056] In a third aspect, the present disclosure provides a digestive tract sleeve 100, as shown in Figure 1, comprising a sleeve body 110 and a release ball core for releasing the distal end of the digestive tract sleeve as in any of the aforementioned embodiments, the release ball core being fixed in a release ball 120 having an inner cavity, and the release ball 120 being connected to the sleeve body 110 through the release ball core, the sleeve body 110 comprising a proximal end and a distal end, and the distal end being connected to the release ball core. Further, please refer to Figure 2. From left to right in Figure 2, the process of releasing the ball inner core and separating from the sleeve body 110 is shown. First, the delivery tube delivers the digestive tract sleeve 100 to the duodenal bulb. The release ball inner core drives the sleeve body 110 to expand away from the duodenal bulb due to gravity. Then the delivery tube is separated from the sleeve body 110, and the release ball inner core can continue to drive the sleeve body 110 to extend until it is fully stretched. Finally, the release ball inner core disintegrates, and the release ball 120 is separated from the sleeve body 110. The delivery of the digestive tract sleeve 100 is completed.

[0057] In an optional embodiment, in order to ensure the final detachment effect, the dry connection force between the inner core of the release ball and the distal end of the digestive tract sleeve is greater than 2.5N, preferably greater than 5N.

[0058] Preferably, the wet connection force between the inner core of the release ball and the distal end of the digestive tract sleeve is less than 1.5N after being kept in the wet state for 2 hours; more preferably, less than 1N.

[0059] In a fourth aspect, the present disclosure provides a release pellet core of a digestive tract sleeve according to any one of the aforementioned embodiments, or use of the digestive tract sleeve according to the aforementioned embodiments in preparing a product for reducing gastrointestinal absorption.

[0060] Example 1

[0061] This embodiment provides a release ball inner core for distal release of a digestive tract sleeve, which includes a filler, a binder, and a disintegrant.

[0062] The fillers are 2g microcrystalline cellulose and 2g type II barium sulfate. The binders are 2g water and 0.12g carboxymethyl cellulose. The disintegrant is 0.1g croscarmellose sodium.

[0063] The above raw materials are mixed in proportion and then wet granulated and tableted. The tableting parameters include a pressure of 0.4 MPa and ethylene oxide sterilization to obtain the release ball core.

[0064] This embodiment further provides a digestive tract sleeve, comprising a sleeve body, the sleeve body comprising a proximal end and a distal end, wherein the inner core of the release ball is connected and fixed to the distal end after being sterilized with ethylene oxide.

[0065] Example 2

[0066] This embodiment provides a release ball inner core for distal release of a digestive tract sleeve, which includes a filler, a binder, and a disintegrant.

[0067] The fillers were 2g microcrystalline cellulose and 2g heavy barium sulfate. The binders were 1.2g water and 1g carboxymethyl cellulose. The disintegrant was 0.1g croscarmellose sodium. The above ingredients were mixed in proportion and subjected to the same wet granulation and tableting process as in Example 1. After sterilization with ethylene oxide, the release pellet core was obtained.

[0068] This embodiment further provides a digestive tract sleeve, comprising a sleeve body, wherein the sleeve body comprises a proximal end and a distal end, wherein the inner core of the release ball is connected and fixed to the distal end after sterilization.

[0069] Example 3

[0070] This embodiment provides a release ball inner core for distal release of a digestive tract sleeve, which includes a filler, a binder, and a disintegrant.

[0071] The filler is 1g microcrystalline cellulose and 2g type II barium sulfate. The binder is 1.2g water and 2g carboxymethyl cellulose. The disintegrant is 0.3g croscarmellose sodium. The above ingredients are mixed in proportion and subjected to the same wet granulation and tableting process as in Example 1. After ethylene oxide sterilization, the release pellet core is obtained.

[0072] This embodiment further provides a digestive tract sleeve, comprising a sleeve body, wherein the sleeve body comprises a proximal end and a distal end, wherein the inner core of the release ball is connected and fixed to the distal end after sterilization.

[0073] Example 4

[0074] This embodiment provides a release ball inner core for distal release of a digestive tract sleeve, which includes a filler, a binder, and a disintegrant.

[0075] The filler is 2g microcrystalline cellulose and 2g type II barium sulfate. The binder is 1.2g water and 0.2g carboxymethyl cellulose. The disintegrant is 0.3g croscarmellose sodium. The above ingredients are mixed in proportion and subjected to the same wet granulation and tableting process as in Example 1. After ethylene oxide sterilization, the release pellet core is obtained.

[0076] This embodiment further provides a digestive tract sleeve, comprising a sleeve body, wherein the sleeve body comprises a proximal end and a distal end, wherein the inner core of the release ball is connected and fixed to the distal end after sterilization.

[0077] Example 5

[0078] This embodiment provides a release ball inner core for distal release of a digestive tract sleeve, which includes a filler, a binder, and a disintegrant.

[0079] The filler is 0.5g microcrystalline cellulose and 3.5g type II barium sulfate. The binder is 1g water and 0.12g carboxymethyl cellulose. The disintegrant is 0.1g sodium chloride. The above ingredients are mixed in proportion and then wet granulated and tableted as in Example 1. After ethylene oxide sterilization, the release pellet core is obtained.

[0080] This embodiment further provides a digestive tract sleeve, comprising a sleeve body, wherein the sleeve body comprises a proximal end and a distal end, wherein the inner core of the release ball is connected and fixed to the distal end after sterilization.

[0081] Example 6

[0082] This embodiment provides a release ball inner core for distal release of a digestive tract sleeve, which includes a filler, a binder, and a disintegrant.

[0083] The filler is 1g microcrystalline cellulose and 3g heavy barium sulfate. The binder is 1g water and 0.12g carboxymethyl cellulose. The disintegrant is 0.1g sodium chloride. The above ingredients are mixed in proportion, compressed into tablets, and sterilized with ethylene oxide to produce the release pellet core.

[0084] This embodiment further provides a digestive tract sleeve, comprising a sleeve body, wherein the sleeve body comprises a proximal end and a distal end, wherein the inner core of the release ball is connected and fixed to the distal end after sterilization.

[0085] Example 7

[0086] This embodiment provides a release ball inner core for distal release of a digestive tract sleeve, which includes a filler, a binder, and a disintegrant.

[0087] The filler is 2.5g microcrystalline cellulose and 2g type II barium sulfate. The binder is 1.2g water and 0.5g carboxymethyl cellulose. The disintegrant is 0.1g sodium chloride. The above ingredients are mixed in proportion and directly compressed into tablets. After sterilization with ethylene oxide, the release pellet core is produced.

[0088] This embodiment further provides a digestive tract sleeve, comprising a sleeve body, wherein the sleeve body comprises a proximal end and a distal end, wherein the inner core of the release ball is connected and fixed to the distal end after sterilization.

[0089] Example 8

[0090] This embodiment provides a release ball inner core for distal release of a digestive tract sleeve, which includes a filler, a binder, and a disintegrant.

[0091] The filler is 2g microcrystalline cellulose and 2.8g type II barium sulfate. The binder is 1g water, 0.2g ethanol, and 0.12g carboxymethyl cellulose. The disintegrant is 0.3g croscarmellose sodium. The above ingredients are mixed in proportion and directly compressed into tablets. 0.2g sodium chloride is then added to the tablets and sterilized with ethylene oxide to produce the release pellet core.

[0092] This embodiment further provides a digestive tract sleeve, comprising a sleeve body, wherein the sleeve body comprises a proximal end and a distal end, wherein the inner core of the release ball is connected and fixed to the distal end after sterilization.

[0093] Comparative Example 1

[0094] This comparative example provides a digestive tract sleeve, which is the same as Example 1, except that the raw materials for preparing the release pellet core do not contain a disintegrant.

[0095] Comparative Example 2

[0096] This comparative example provides a digestive tract sleeve, which is the same as Example 2, except that the raw materials for preparing the release pellet core do not contain a disintegrant.

[0097] Comparative Example 3

[0098] This comparative example provides a digestive tract sleeve, which is the same as Example 3, except that the raw materials for preparing the release pellet core do not contain a disintegrant.

[0099] Comparative Example 4

[0100] This comparative example provides a digestive tract sleeve, which is the same as Example 4, except that the raw materials for preparing the release pellet core do not contain a disintegrant.

[0101] Comparative Example 5

[0102] This comparative example provides a digestive tract sleeve, which is the same as Example 5, except that the raw materials for preparing the release pellet core do not contain a disintegrant.

[0103] Comparative Example 6

[0104] This comparative example provides a digestive tract sleeve, which is the same as Example 6, except that the raw materials for preparing the release pellet core do not contain a disintegrant.

[0105] Comparative Example 7

[0106] This comparative example provides a digestive tract sleeve, which is the same as Example 7, except that the raw materials for preparing the release pellet core do not contain a disintegrant.

[0107] Comparative Example 8

[0108] This comparative example provides a digestive tract sleeve, which is the same as Example 8, except that the raw materials for preparing the release pellet core do not contain a disintegrant.

[0109] Comparative Example 9

[0110] This comparative example provides a release ball core for a digestive tract sleeve, which differs from Example 1 in that the type of disintegrant is different, namely dry starch.

[0111] Comparative Example 10

[0112] This comparative example provides a release pellet core for a digestive tract sleeve, which differs from Example 2 in that the type of disintegrant is different, namely, cross-linked polyvinylpyrrolidone.

[0113] Comparative Example 11

[0114] This comparative example provides a release pellet core for a digestive tract sleeve, which differs from Example 3 in that the type of disintegrant is different, namely low-substituted hydroxypropyl cellulose.

[0115] Test Example 1

[0116] The disintegration time, dry-state connection force, and wet-state connection force of the digestive tract sleeves provided in Examples 1 to 8 and Comparative Examples 1 to 11 were tested in physiological saline;

[0117] The test method is as follows:

[0118] 1. Disintegration time: Refer to the disintegration time inspection method in 0921 of the 2020 edition of the Pharmacopoeia of the People's Republic of China.

[0119] 2. Dry connection strength test method: Clamp the release ball and membrane tube separately on a universal material testing machine, stretch them at a speed of 20mm / min until the release ball and membrane tube are free from force, and record the maximum force.

[0120] 3. Wet connection strength test method: Place the release ball in physiological saline and shake it at 40 rpm in a 37±2℃ water bath for 2 hours. Then clamp the release ball and the membrane tube on a universal material testing machine and stretch them at a speed of 20 mm / min until the release ball and the membrane tube are separated. Record the maximum force.

[0121] After testing, the results are shown in Table 1.

[0122] Table 1 The time for releasing balls of different shapes to separate from the cannula body

[0123] As can be seen from Table 1, the inner core of the release ball of the embodiment of the present disclosure has a short disintegration time limit, has better disintegration ability, is more suitable for the self-expansion completion of the sleeve body and is more suitable for the sleeve to be put into use, and will not block the sleeve body for a long time.

[0124] Test Example 2

[0125] The digestive tract cannulas prepared in Examples 1 to 3 and Comparative Example 1 were placed in Bama pigs. The disintegration time of the release sphere cores prepared in Examples 1 to 3 and Comparative Example 1 in the pigs was examined, and the time it took for the release spheres to separate from the membrane tube in the animals was examined using X-rays, resulting in the results shown in FIG3 . FIG3 shows that the release spheres of the disclosed embodiments can separate the release sphere cores from the cannula body in the animals by controlling the combination and ratio of their raw materials. However, the release spheres of Comparative Example 1 were unable to disintegrate and separate from the cannula body, resulting in a dark shadow showing the connection between the release sphere core and the cannula body in the image, which is not conducive to the use of the digestive tract cannula.

[0126] The above are merely preferred embodiments of the present disclosure and are not intended to limit the present disclosure. Those skilled in the art will readily appreciate that various modifications and variations of the present disclosure are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present disclosure shall be included within the scope of protection of the present disclosure. Industrial Applicability

[0127] The present invention can self-expand in the digestive tract, is simple and convenient to operate, greatly shortens the operation time of inserting the digestive tract sleeve, and has good utilization value.

Claims

1. A release ball inner core for distal release of a digestive tract cannula, characterized in that: It includes a filler, a binder and a disintegrant in a mass ratio of 50-90:10-50:0-20; The filler comprises at least one of starch, microcrystalline cellulose and inorganic salt; The binder includes at least one of water, ethanol, hypromellose, carboxymethylcellulose or its salt, methylcellulose and syrup.

2. The release ball inner core for distal release of the digestive tract sleeve according to claim 1, characterized in that: The inorganic salt includes at least one of calcium sulfate, calcium hydrogen phosphate, calcium carbonate and barium sulfate; Preferably, the barium sulfate is any one of heavy barium sulfate, type I barium sulfate and type II barium sulfate; More preferably, the barium sulfate is heavy barium sulfate or type II barium sulfate.

3. The release ball inner core for distal release of the digestive tract sleeve according to claim 2, characterized in that: The filler comprises any one of the following two combinations: microcrystalline cellulose and calcium carbonate or microcrystalline cellulose and barium sulfate; preferably microcrystalline cellulose and barium sulfate; Preferably, the mass ratio of the filler to the binder is 56.2-86.9:13.1-42.

2.

4. The release ball inner core for distal release of the digestive tract sleeve according to claim 1, characterized in that: The disintegrant comprises at least one of cross-linked sodium carboxymethyl starch, cross-linked polyvinyl pyrrolidone, cross-linked sodium carboxymethyl cellulose and sodium chloride.

5. The release ball inner core for distal release of the digestive tract sleeve according to claim 1 or 4, characterized in that: It also includes auxiliary materials, and the mass ratio of the filler to the auxiliary materials is 50-90:0.01-5.

6. The release ball inner core for distal release of the digestive tract sleeve according to claim 5, characterized in that: The auxiliary material includes at least one of an antioxidant, a preservative and a fragrance.

7. A method for preparing the inner core of the releasing ball for distal release of the digestive tract sleeve according to any one of claims 1 to 6, characterized in that: The method comprises mixing the raw materials in proportion and then tableting, wherein the tableting method comprises any one of a wet granulation tableting method, a direct tableting method and a molding method; Preferably, the tableting method is wet granulation tableting or compression molding; more preferably, wet granulation tableting.

8. A digestive tract cannula, characterized in that: It comprises a sleeve body and a release ball inner core for releasing the distal end of the digestive tract sleeve as described in any one of claims 1 to 6, wherein the release ball inner core is fixed in a release ball having an inner cavity, and the sleeve body comprises a proximal end and a distal end, wherein the distal end is connected to the release ball inner core.

9. The digestive tract sleeve according to claim 8, characterized in that: The dry connection force between the inner core of the release ball and the distal end of the digestive tract sleeve is greater than 2.5N, preferably greater than 5N; Preferably, the wet connection force between the inner core of the release ball and the distal end of the digestive tract sleeve is less than 1.5N after being kept in the wet state for 2 hours; more preferably, less than 1N.

10. Use of the releasing ball inner core for distal release of the digestive tract sleeve as claimed in any one of claims 1 to 6 or the digestive tract sleeve as claimed in claim 8 or 9 in a product for reducing gastrointestinal absorption after being sterilized with ethylene oxide.

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