Release pellet inner core for releasing distal end of digestive tract cannula and preparation method and application thereof

Abstract

The application provides a releasing pellet inner core for releasing a distal end of a digestive tract cannula and a preparation method and application thereof, and relates to the technical field of medical devices. The releasing pellet inner core comprises 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 comprises at least one of water, ethanol, hydroxypropyl methyl cellulose, carboxymethyl cellulose or a salt thereof, methyl cellulose and sugar syrup. With the help of peristalsis of the digestive tract and gravity of the releasing pellet, the cannula body is driven to move in the digestive tract until the cannula is completely stretched. After the cannula body is completely stretched, the releasing pellet inner core is separated from the cannula body by controlling the composition of the releasing pellet inner core, and the implantation operation of the digestive tract cannula is completed. The operation method is simple, the time for implanting the digestive tract cannula is greatly shortened, and the risk of infection and the harm of radiation are reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a release ball core for distal release of a digestive tract cannula, its preparation method, and its application. Background Technology

[0002] As our understanding of obesity deepens, we recognize that obesity is not merely weight gain, but a syndrome accompanied by a range of chronic diseases, including type 2 diabetes, hypertension, sleep apnea, and polycystic ovary syndrome. Overweight and obesity increase the risk of various adult chronic diseases, leading not only to serious cardiovascular and cerebrovascular diseases and endocrine and metabolic disorders, but also to respiratory, digestive, and musculoskeletal disorders, and are associated with the development of various malignant tumors. Furthermore, obesity has become a significant factor affecting mental health and social interaction, and also increases the economic burden.

[0003] Currently, the main treatments for obesity include diet, exercise and behavioral interventions, drug therapy, and bariatric surgery. Due to the long duration of treatment, adherence to these methods is difficult, and the weight loss effect of diet, exercise and behavioral interventions is only 3-5%. Although bariatric drugs can provide additional weight loss benefits, data from the US Electronic Medical Records Database show that prescription rates and continued use of bariatric drugs are very low due to side effects. Bariatric surgery is effective for all of the above conditions, but it involves irreversible physiological trauma, a certain mortality rate, and postoperative complications such as gastrointestinal leakage, anastomotic stenosis, and dumping syndrome. In recent years, drawing on the principle of gastric bypass surgery in bariatric surgery, the insertion of a cannula in the duodenal-jejunal segment to isolate chyme from the intestine and reduce intestinal absorption for weight loss has attracted widespread research interest.

[0004] CN109152570 discloses a method for endoscopic cannulation, but this method requires manual connection between the distal end of the cannula and the distal cap, and requires injecting liquid into the cannula to allow it to extend and take shape smoothly within the digestive tract. This method is complex, takes a long time to insert, and must be performed under X-ray guidance, significantly increasing the risk of infection and radiation hazards. Therefore, there is an urgent need for a new method for releasing a digestive tract cannula to address these problems.

[0005] In view of this, the present invention is proposed. Summary of the Invention

[0006] The purpose of this invention is to provide a release ball core for distal release of a digestive tract cannula, its preparation method, and its application. It can self-expand in the digestive tract, is simple and convenient to operate, and greatly shortens the insertion time of the digestive tract cannula.

[0007] The embodiments of the present invention are implemented as follows:

[0008] In a first aspect, the present invention provides a release ball core for distal release of a digestive tract cannula, comprising a filler, a binder, and a disintegrant in a mass ratio of 50-90:10-50:0-20.

[0009] The filler includes at least one of starch, microcrystalline cellulose, and inorganic salt.

[0010] The adhesive includes at least one of water, ethanol, hydroxypropyl methylcellulose, carboxymethyl cellulose or its salts, methylcellulose, and syrup.

[0011] In an optional embodiment, the inorganic salt includes at least one of calcium sulfate, calcium hydrogen phosphate, calcium carbonate, and barium sulfate.

[0012] Preferably, the barium sulfate is any one of heavy barium sulfate, type I barium sulfate, or type II barium sulfate.

[0013] More preferably, the barium sulfate is heavy barium sulfate or type II barium sulfate.

[0014] In an optional embodiment, the filler includes any one of the following two combinations: microcrystalline cellulose and calcium carbonate, or microcrystalline cellulose and barium sulfate; preferably microcrystalline cellulose and barium sulfate.

[0015] Preferably, the mass ratio of filler to adhesive is 56.2–86.9:13.1–42.2.

[0016] In an optional embodiment, the disintegrant includes at least one of croscarmellose sodium, croscarmellose polyvinylpyrrolidone, croscarmellose sodium cellulose, and sodium chloride.

[0017] In an optional embodiment, it also includes excipients, with the mass ratio of filler to excipients being 50-90:0.01-5.

[0018] Preferably, the excipients include at least one of antioxidants, preservatives, and fragrances.

[0019] Secondly, the present invention provides a method for preparing a release pellet core for distal release of a digestive tract cannula as described in any of the foregoing embodiments, comprising mixing raw materials in a certain proportion and then compressing them into tablets, wherein the tableting method includes any one of wet granulation tableting, direct tableting, and molding.

[0020] Preferably, the tableting method is wet granulation tableting or molding tableting; more preferably, it is wet granulation tableting.

[0021] Thirdly, the present invention provides a digestive tract cannula, including a cannula body and a release ball core for distal release of the digestive tract cannula as described in any of the foregoing embodiments. The release ball core is fixed inside a release ball having an inner lumen. The cannula body includes a proximal end and a distal end, and the distal end is connected to the release ball core.

[0022] In an optional embodiment, the dry connection force between the inner core of the release ball and the distal end of the digestive tract cannula is greater than 2.5N, preferably greater than 5N.

[0023] Preferably, the wet connection force between the inner core of the release ball and the distal end of the digestive tract cannula is less than 1.5N after being kept wet for 2 hours; more preferably, it is less than 1N.

[0024] Fourthly, the present invention provides a release ball core for distal release of a digestive tract cannula as described in any of the foregoing embodiments, or the digestive tract cannula as described in the foregoing embodiments, in the preparation of products that reduce gastrointestinal absorption.

[0025] The beneficial effects of the embodiments of the present invention are:

[0026] This invention provides a release bulb core for distal deployment of a digestive tract cannula, its preparation method, and its application. During deployment, the cannula extends thanks to natural intestinal peristalsis. By controlling the composition of the release bulb core, once fully deployed, it disintegrates and loses its structure and mechanical properties due to the mucus in the distal intestinal tract, causing the cannula to detach from the release bulb core. The entire process requires no additional intervention from medical personnel. The method is simple, significantly reducing the time required for digestive tract cannula insertion and lowering the risk of infection and X-ray radiation. Attached Figure Description

[0027] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 A schematic diagram of the digestive tract cannula provided by this invention;

[0029] Figure 2 A schematic diagram illustrating the delivery process of the digestive tract cannula provided by the present invention;

[0030] Figure 3 This is a digital gastrointestinal imaging image provided in Experimental Example 2 of the present invention, 4 hours after the release of the digestive tract cannula.

[0031] Illustration: 100 - Digestive tract cannula; 110 - Cannula body; 120 - Release ball. Detailed Implementation

[0032] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0033] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0034] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0035] In the description of this invention, it should be noted that the terms "inner" and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this invention is usually placed when in use. They are only used to facilitate the description of this invention and to simplify the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0036] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0037] In a first aspect, the present invention provides a release ball core for distal release of a digestive tract cannula, 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 salt.

[0039] The adhesive includes at least one of water, ethanol, hydroxypropyl methylcellulose, carboxymethyl cellulose or its salts, methylcellulose, and syrup.

[0040] Currently, most gastrointestinal cannulas are inserted by injecting fluid to expand the cannula. However, the process of injecting fluid and waiting for the cannula to expand is lengthy, increasing the insertion time and difficulty. Therefore, the inventors creatively proposed incorporating a release sphere core into the gastrointestinal cannula. This sphere can self-expand within the gastrointestinal tract using its own weight, allowing for direct insertion without the need for prolonged waiting for full expansion, thus simplifying the procedure. However, since this release sphere core requires sterilization before use, typically using substances like ethylene oxide, the disintegration effect of conventional sustained-release structures or disintegrating particles is significantly altered after sterilization.

[0041] For example, a product that originally took about 2 hours to disintegrate still failed to disintegrate 24 hours after ethylene oxide sterilization. Therefore, ensuring that the release sphere core maintains good disintegration performance after sterilization is key to whether this product can successfully achieve the effect described above: "no need to wait a long time for the sleeve to fully expand, making operation simpler."

[0042] The inventors proposed a method using a compound of filler, binder, and disintegrant, and screened the raw material composition and ratio to obtain a release microsphere core that maintains excellent disintegration performance after sterilization. The disintegration mechanism of this invention mainly includes two aspects: one is capillary action promoting disintegration: the release microsphere core has many capillaries and pores. Upon contact with water, water enters the interior of the release microsphere core through these hydrophilic channels. The strong water absorption lubricates the release microsphere core, causing it to disintegrate. The disintegration of cellulose derivatives is often related to this. The other is erosion: when the release microsphere core encounters intestinal fluid in the duodenum, the soluble components in the release microsphere core, such as the disintegrant, dissolve upon contact with water, forming erosive pores. This causes the core to break into fine particles, which, after dissolution, form "cavities," accelerating disintegration.

[0043] In an optional 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, or type II barium sulfate. Barium sulfate has imaging capabilities; therefore, when barium sulfate is selected as the filler, the release pellet core provided by this invention has imaging capabilities, allowing for better observation of its position within the digestive tract during insertion, thus determining whether the digestive tract cannula has been properly delivered.

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

[0046] In an optional embodiment, the filler includes 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 filler to adhesive is 56.2–86.9:13.1–42.2.

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

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

[0050] Preferably, the disintegrant includes at least one selected from croscarmellose sodium, croscarmellose polyvinylpyrrolidone, croscarmellose sodium 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 excipients include at least one of antioxidants, preservatives, and fragrances.

[0054] Secondly, the present invention provides a method for preparing a release pellet core for distal release of a digestive tract cannula as described in any of the foregoing embodiments, comprising mixing raw materials in a certain proportion and then compressing them into tablets, wherein the tableting method includes any one of wet granulation tableting, direct tableting, and molding.

[0055] Preferably, the tableting method is wet granulation tableting or molding tableting; more preferably, it is wet granulation tableting, and the specific method can be referred to the existing tableting methods.

[0056] Thirdly, the present invention provides a digestive tract cannula 100, please refer to... Figure 1 As shown, the device includes a cannula body 110 and a release ball core for distal release of the digestive tract cannula as described in any of the foregoing embodiments. The release ball core is fixed within a release ball 120 having an inner lumen, and the release ball 120 is connected to the cannula body 110 via the release ball core. The cannula body 110 includes a proximal end and a distal end, with the distal end connected to the release ball core. Further, please refer to... Figure 2 As shown, Figure 2From left to right, the process of the release ball core separating from the cannula body 110 is as follows: First, the delivery tube delivers the digestive tract cannula 100 to the duodenal bulb. Due to gravity, the release ball core causes the cannula body 110 to unfold away from the duodenal bulb. Then, the delivery tube separates from the cannula body 110. The release ball core can continue to cause the cannula body 110 to extend until it is fully extended. Finally, the release ball core disintegrates, and the release ball 120 separates from the cannula body 110, thus completing the delivery of the digestive tract cannula 100.

[0057] In an optional implementation, 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 cannula 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 cannula is less than 1.5N after being kept wet for 2 hours; more preferably, it is less than 1N.

[0059] Fourthly, the present invention provides a release ball core of a digestive tract cannula as described in any of the foregoing embodiments, or the use of a digestive tract cannula as described in the foregoing embodiments in the preparation of products that reduce gastrointestinal absorption.

[0060] Example 1

[0061] This embodiment provides a release ball core for distal release of a digestive tract cannula, which includes a filler, an adhesive, and a disintegrant.

[0062] The filler consists of 2g of microcrystalline cellulose and 2g of barium sulfate type II. The binder consists of 2g of water and 0.12g of carboxymethyl cellulose. The disintegrant consists of 0.1g of 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. After sterilization with ethylene oxide, the release sphere core is obtained.

[0064] This embodiment also provides a digestive tract cannula, including a cannula body, the cannula body including a proximal end and a distal end, wherein the inner core of the aforementioned release sphere is sterilized with ethylene oxide and then connected and fixed to the distal end.

[0065] Example 2

[0066] This embodiment provides a release ball core for distal release of a digestive tract cannula, which includes a filler, an adhesive, and a disintegrant.

[0067] The filler consists of 2g of microcrystalline cellulose and 2g of heavy barium sulfate. The binder consists of 1.2g of water and 1g of carboxymethyl cellulose. The disintegrant is 0.1g of croscarmellose sodium. The above raw materials are mixed in the specified proportions and then subjected to wet granulation and tableting as in Example 1. After sterilization with ethylene oxide, the release sphere core is obtained.

[0068] This embodiment also provides a digestive tract cannula, including a cannula body, the cannula body including a proximal end and a distal end, wherein the inner core of the release ball is sterilized and connected and fixed to the distal end.

[0069] Example 3

[0070] This embodiment provides a release ball core for distal release of a digestive tract cannula, which includes a filler, an adhesive, and a disintegrant.

[0071] The filler consists of 1g microcrystalline cellulose and 2g barium sulfate type II. The binder consists of 1.2g water and 2g carboxymethyl cellulose, and the disintegrant consists of 0.3g croscarmellose sodium. The above raw materials are mixed in the specified proportions and then subjected to wet granulation and tableting as in Example 1. After sterilization with ethylene oxide, the release sphere core is obtained.

[0072] This embodiment also provides a digestive tract cannula, including a cannula body, the cannula body including a proximal end and a distal end, wherein the inner core of the release ball is sterilized and connected and fixed to the distal end.

[0073] Example 4

[0074] This embodiment provides a release ball core for distal release of a digestive tract cannula, which includes a filler, an adhesive, and a disintegrant.

[0075] The filler consists of 2g of microcrystalline cellulose and 2g of barium sulfate type II. The binder consists of 1.2g of water and 0.2g of carboxymethyl cellulose, and the disintegrant consists of 0.3g of croscarmellose sodium. The above raw materials are mixed in the specified proportions and then subjected to wet granulation and tableting as in Example 1. After sterilization with ethylene oxide, the release sphere core is obtained.

[0076] This embodiment also provides a digestive tract cannula, including a cannula body, the cannula body including a proximal end and a distal end, wherein the inner core of the release ball is sterilized and connected and fixed to the distal end.

[0077] Example 5

[0078] This embodiment provides a release ball core for distal release of a digestive tract cannula, which includes a filler, an adhesive, and a disintegrant.

[0079] The filler consists of 0.5g microcrystalline cellulose and 3.5g type II barium sulfate. The binder consists of 1g water and 0.12g carboxymethyl cellulose, and the disintegrant consists of 0.1g sodium chloride. The above raw materials are mixed in the specified proportions and then subjected to wet granulation and tableting as in Example 1. After sterilization with ethylene oxide, the release sphere core is obtained.

[0080] This embodiment also provides a digestive tract cannula, including a cannula body, the cannula body including a proximal end and a distal end, wherein the inner core of the release ball is sterilized and connected and fixed to the distal end.

[0081] Example 6

[0082] This embodiment provides a release ball core for distal release of a digestive tract cannula, which includes a filler, an adhesive, and a disintegrant.

[0083] The filler consists of 1g of microcrystalline cellulose and 3g of heavy barium sulfate. The binder consists of 1g of water and 0.12g of carboxymethyl cellulose, and the disintegrant consists of 0.1g of sodium chloride. The above raw materials are mixed in proportion and then compressed into tablets using a molding method. After sterilization with ethylene oxide, the tablet core is obtained.

[0084] This embodiment also provides a digestive tract cannula, including a cannula body, the cannula body including a proximal end and a distal end, wherein the inner core of the release ball is sterilized and connected and fixed to the distal end.

[0085] Example 7

[0086] This embodiment provides a release ball core for distal release of a digestive tract cannula, which includes a filler, an adhesive, and a disintegrant.

[0087] The filler consists of 2.5g microcrystalline cellulose and 2g barium sulfate type II. The binder consists of 1.2g water and 0.5g carboxymethyl cellulose, and the disintegrant consists of 0.1g sodium chloride. The above raw materials are mixed in the specified proportions and then directly compressed into tablets. After sterilization with ethylene oxide, the tablet core is obtained.

[0088] This embodiment also provides a digestive tract cannula, including a cannula body, the cannula body including a proximal end and a distal end, wherein the inner core of the release ball is sterilized and connected and fixed to the distal end.

[0089] Example 8

[0090] This embodiment provides a release ball core for distal release of a digestive tract cannula, which includes a filler, an adhesive, and a disintegrant.

[0091] The filler consists of 2g of microcrystalline cellulose and 2.8g of barium sulfate type II. The binder consists of 1g of water, 0.2g of ethanol, and 0.12g of carboxymethyl cellulose, and the disintegrant is 0.3g of croscarmellose sodium. The above raw materials are mixed in the specified proportions and then directly compressed into tablets. 0.2g of sodium chloride is added during compression, and the tablets are sterilized with ethylene oxide to obtain the release sphere core.

[0092] This embodiment also provides a digestive tract cannula, including a cannula body, the cannula body including a proximal end and a distal end, wherein the inner core of the release ball is sterilized and connected and fixed to the distal end.

[0093] Comparative Example 1

[0094] This comparative example provides a digestive tract cannula, which is the same as that in 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 cannula, which is the same as that in Example 2, except that the raw materials for preparing the release sphere core do not contain a disintegrant.

[0097] Comparative Example 3

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

[0099] Comparative Example 4

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

[0101] Comparative Example 5

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

[0103] Comparative Example 6

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

[0105] Comparative Example 7

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

[0107] Comparative Example 8

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

[0109] Comparative Example 9

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

[0111] Comparative Example 10

[0112] This comparative example provides a release sphere core for a digestive tract cannula, which differs from Example 2 in that it uses a different type of disintegrant, namely cross-linked polyvinylpyrrolidone.

[0113] Comparative Example 11

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

[0115] Experimental Example 1

[0116] The disintegration time, dry adhesion and wet adhesion of the digestive tract cannulas provided in Examples 1-8 and Comparative Examples 1-11 were tested in physiological saline.

[0117] The testing method is as follows:

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

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

[0120] 3. Wet-state bonding force test method: The release ball is placed in physiological saline and shaken at 40 rpm for 2 hours in a water bath at 37±2℃. Then, the release ball and the membrane tube are clamped on a universal testing machine and stretched at a speed of 20 mm / min until the release ball and the membrane tube are released. The maximum force is recorded.

[0121] The results obtained after testing are shown in Table 1.

[0122] Table 1. Time for release balls of different shapes to detach from the cannula body.

[0123]

[0124]

[0125] As shown in Table 1, the release ball core of the present invention has a short disintegration time, better disintegration ability, is more suitable for the self-expansion of the casing body, and is more suitable for the casing to be put into use, and will not block the casing body for a long time.

[0126] Experimental Example 2

[0127] The digestive tract cannulas prepared in Examples 1-3 and Comparative Example 1 were placed in Bama pigs. The disintegration time of the release sphere cores prepared in Examples 1-3 and Comparative Example 1 in the pigs was examined, and the detachment time of the release spheres from the membrane tubes in the animals was examined using X-ray film. The results were as follows: Figure 3 As shown, by Figure 3 As can be seen, the release pellets of the present invention can achieve the release of the pellet core from the cannula body in the animal body by controlling the combination and ratio of its raw materials. However, the release pellets of Comparative Example 1 cannot disintegrate and cannot detach from the cannula body. Therefore, the image shows a dark shadow connecting the release pellet core to the cannula body, which is not conducive to the use of the digestive tract cannula.

[0128] The above are merely preferred embodiments of the present invention and are not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A digestive tract cannula, characterized in that, The device includes a cannula body and a release ball core for distal release of a digestive tract cannula. The release ball core is fixed inside a release ball having an inner lumen. The cannula body includes a proximal end and a distal end, and the distal end is connected to the release ball core. The raw materials for the release sphere core include fillers, binders, and disintegrants in a mass ratio of 50~90:10~50:0.01~20; The filler includes at least one of starch, microcrystalline cellulose, and inorganic salts; The adhesive comprises at least one of water, ethanol, hydroxypropyl methylcellulose, carboxymethyl cellulose or its salts, methylcellulose, and syrup; The disintegrant includes at least one of croscarmellose sodium, croscarmellose sodium cellulose, and sodium chloride.

2. The digestive tract cannula 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; The barium sulfate is any one of heavy barium sulfate, type I barium sulfate, or type II barium sulfate.

3. The digestive tract cannula according to claim 2, characterized in that, The filler includes either of the following two combinations: microcrystalline cellulose and calcium carbonate, or microcrystalline cellulose and barium sulfate.

4. The digestive tract cannula according to claim 3, characterized in that, The mass ratio of the filler to the adhesive is 56.2~86.9:13.1~42.

2.

5. The digestive tract cannula according to claim 1, characterized in that, It also includes excipients, wherein the mass ratio of the filler to the excipients is 50~90:0.01~5.

6. The digestive tract cannula according to claim 5, characterized in that, The excipients include at least one of antioxidants, preservatives, and fragrances.

7. The digestive tract cannula according to claim 1, characterized in that, The method for preparing the release sphere core includes mixing raw materials in a certain proportion and then compressing them into tablets. The tableting method includes any one of wet granulation tableting, direct tableting, and molding.

8. The digestive tract cannula according to claim 1, characterized in that, The dry connection force between the inner core of the release ball and the distal end of the digestive tract cannula is greater than 2.5 N.

9. The digestive tract cannula according to claim 1, characterized in that, The dry connection force between the inner core of the release ball and the distal end of the digestive tract cannula is greater than 5N.

10. The digestive tract cannula according to claim 1, characterized in that, The wet connection force between the inner core of the release ball and the distal end of the digestive tract cannula is less than 1.5N after being kept wet for 2 hours.

11. The digestive tract cannula according to claim 1, characterized in that, The wet connection force between the inner core of the release ball and the distal end of the digestive tract cannula is less than 1N after being kept wet for 2 hours.

12. The use of a digestive tract cannula as described in any one of claims 1 to 11, sterilized with ethylene oxide, in a product that reduces gastrointestinal absorption.

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