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EP-4740973-A1 - RELEASE BALLOON CORE FOR DISTAL END RELEASE OF DIGESTIVE TRACT CANNULA, PREPARATION METHOD THEREFOR AND USE THEREOF

EP4740973A1EP 4740973 A1EP4740973 A1EP 4740973A1EP-4740973-A1

Abstract

The present invention provides a release-ball core for distal-end release of a gastrointestinal sleeve, and a preparation method therefor and use thereof, and relates to the technical field of medical devices. The release-ball core includes a filler, a binder, and a disintegrant in a mass ratio of 50-90:10-50:0-20. The filler includes at least one of starch, microcrystalline cellulose, and an inorganic salt. The binder includes at least one of water, ethanol, hydroxypropyl methylcellulose, carboxymethyl cellulose or salts thereof, methylcellulose, and syrup. With gastrointestinal peristalsis and the weight of the release-ball core, the sleeve body is driven to move within the gastrointestinal tract until full self-deployment is achieved. After the self-deployment of the sleeve body, the composition of the release-ball core is controlled to enable detachment from the sleeve body, completing the insertion of the gastrointestinal sleeve. This method provides simple operation, significantly reduces the insertion time of the gastrointestinal sleeve, and lowers the risk of infection and radiation exposure.

Inventors

  • LI, WENYU

Assignees

  • Hangzhou Tangji Medical Technology Co., Ltd.

Dates

Publication Date
20260513
Application Date
20240320

Claims (10)

  1. A release-ball core for distal-end release of a gastrointestinal sleeve, characterized by comprising a filler, a binder, and a disintegrant in a mass ratio of 50-90:10-50:0-20, wherein the filler comprises at least one of starch, microcrystalline cellulose, and an inorganic salt; and the binder comprises at least one of water, ethanol, hydroxypropyl methylcellulose, carboxymethyl cellulose or salts thereof, methylcellulose, and syrup.
  2. The release-ball core for distal-end release of a gastrointestinal sleeve according to claim 1, wherein the inorganic salt comprises at least one of calcium sulfate, dicalcium 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; and more preferably, the barium sulfate is heavy barium sulfate or type II barium sulfate.
  3. The release-ball core for distal-end release of a gastrointestinal sleeve according to claim 2, wherein the filler comprises either one of the following combinations: microcrystalline cellulose and calcium carbonate, or microcrystalline cellulose and barium sulfate; preferably, the filler comprises microcrystalline cellulose and barium sulfate; and preferably, a mass ratio of the filler to the binder is 56.2-86.9:13.1-42.2.
  4. The release-ball core for distal-end release of a gastrointestinal sleeve according to claim 1, wherein the disintegrant comprises at least one of crosslinked sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone, crosslinked sodium carboxymethyl cellulose, and sodium chloride.
  5. The release-ball core for distal-end release of a gastrointestinal sleeve according to claim 1 or 4, further comprising an excipient, wherein a mass ratio of the filler to the excipient is 50-90:0.01-5.
  6. The release-ball core for distal-end release of a gastrointestinal sleeve according to claim 5, wherein the excipient comprises at least one of an antioxidant, a preservative, and a flavoring agent.
  7. A preparation method of the release-ball core for distal-end release of a gastrointestinal sleeve according to any one of claims 1 to 6, characterized by comprising mixing raw materials in a predetermined proportion followed by tableting, wherein the tableting method comprises any one of a wet granulation tableting method, a direct compression method, and a molding method; preferably, the tableting method is a wet granulation tableting method or a molding method; and more preferably, the tableting method is a wet granulation tableting method.
  8. A gastrointestinal sleeve, characterized by comprising a sleeve body and the release-ball core for distal-end release of a gastrointestinal sleeve according to any one of claims 1 to 6, wherein the release-ball core is fixed within a release ball having a lumen, the sleeve body comprises a proximal end and a distal end, and the distal end is connected to the release-ball core.
  9. The gastrointestinal sleeve according to claim 8, wherein a dry-state connection force between the release-ball core and the distal end of the gastrointestinal sleeve is greater than 2.5 N, preferably, the dry-state connection force is greater than 5 N; preferably, after maintaining a wet state for 2 h, a wet-state connection force between the release-ball core and the distal end of the gastrointestinal sleeve is less than 1.5 N; and more preferably, the wet-state connection force is less than 1 N.
  10. Use of the release-ball core for distal-end release of a gastrointestinal sleeve according to any one of claims 1-6, or the gastrointestinal sleeve according to claim 8 or 9, after ethylene oxide sterilization, in a product for reducing gastrointestinal absorption.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present invention claims priority to Chinese Patent Application No. 202311152577X, filed with the China National Intellectual Property Administration on September 7, 2023, and entitled "RELEASE-BALL CORE FOR DISTAL-END RELEASE OF GASTROINTESTINAL SLEEVE, AND PREPARATION METHOD THEREFOR AND USE THEREOF", which is incorporated herein by reference in its entirety. TECHNICAL FIELD The present invention relates to the technical field of medical devices, and specifically, to a release-ball core for distal-end release of a gastrointestinal sleeve, and a preparation method therefor and use thereof. BACKGROUND With the deepening and advancing understanding of obesity, it is recognized that obesity is not merely an increase in body weight but accompanied by a symptom of a chronic disease including type 2 diabetes, hypertension, sleep apnea, polycystic ovary syndrome, and the like. Overweight and obesity increase the risk of multiple chronic conditions in adults, which not only lead to severe cardiovascular and cerebrovascular disorders, endocrine and metabolic imbalances, but lead to respiratory, digestive, and musculoskeletal system impairments, and are associated with the development of various malignancies. In addition, obesity also affects mental health and social interactions and contributes to an increased economic burden. The prevalence of obesity-related chronic diseases in China demonstrates a concerning upward trend. According to WHO standards, with a BMI ≥ 30 kg/m2 defining obesity, the prevalence of obesity among Chinese adults increased nearly eightfold between 1980 and 2015. The Report on Nutrition and Health Status of Primary and Secondary School Students in Beijing (2017) indicates that in 2017, the prevalence of overweight and obesity among monitored students in Beijing reached 15.9% and 16.9%, respectively, resulting in a combined overweight and obesity prevalence of 32.8%, which aligns with the prevalence observed in the United States. Over the past 20 years, overweight and obesity rates among Chinese residents have increased significantly, surpassing the overweight and obesity rates reported in several developed countries. Current major treatments for obesity include dietary, exercise, and behavioral interventions, pharmacological treatments, and bariatric surgery, which presents a significant challenge due to long duration, and the associated weight loss typically reaches only 3-5%. Although pharmacological treatments can provide additional weight loss benefits, data from electronic medical records in the United States indicate that prescription rates and continuous usage of weight loss drugs remain low due to drug-related adverse effects. Bariatric surgery demonstrates higher efficacy in achieving weight reduction. However, bariatric surgery involves irreversible physiological changes, has a certain risk of mortality, and may result in postoperative complications, such as gastrointestinal leakage, anastomotic stricture, or dumping syndrome. In recent years, inspired by the principles of gastric bypass surgery for weight loss, a sleeve has been placed in the duodenum-jejunum segment to isolate chyme from contact with the intestinal tract, thereby reducing intestinal absorption and achieving weight loss, which has attracted wide research interest from scholars. Chinese Patent Application No. CN109152570 discloses a method for endoscopic insertion of a sleeve. However, this method requires manual connection between a distal end of the sleeve and a distal cap, and injection of fluid into the sleeve to enable proper extension and shaping of the sleeve within a gastrointestinal tract. The method involves complex operations, prolonged sleeve insertion time, and needs to be operated under X-ray, which significantly increases the risk of infection and radiation hazards. Therefore, there is an urgent need for a novel method for gastrointestinal sleeve release to overcome the above problems. In view of this, the present invention is proposed. SUMMARY An objective of the present invention is to provide a release-ball core for distal-end release of a gastrointestinal sleeve, and a preparation method therefor and use thereof, where the release-ball core is capable of self-deploying within the gastrointestinal tract, is simple and convenient to operate, and significantly shortens an insertion time of the gastrointestinal sleeve. Embodiments of the present invention are implemented as follows. In a first aspect, the present invention provides a release-ball core for distal-end release of a gastrointestinal sleeve. The release-ball core includes a filler, a binder, and a disintegrant in a mass ratio of 50-90:10-50:0-20. The filler includes at least one of starch, microcrystalline cellulose, and an inorganic salt. The binder includes at least one of water, ethanol, hydroxypropyl methylcellulose, carboxymethyl cellulose or salts thereof, methylcellulose, and syrup. In an