Gradable detachable digestive tract implant cannula and digestive tract implant kit

Abstract

The present application relates to the field of medical instruments. Disclosed are a gradable detachable digestive tract implant cannula and a digestive tract implant kit. The gradable detachable digestive tract implant cannula has a cannula length of 60-150 cm and has a proximal end and a distal end. At least one low-stress portion is arranged on the cannula at a distance of 30-120 cm from the proximal end. When the cannula becomes obstructed, the low-stress portion can undergo fracture in response to intestinal peristaltic forces. The digestive tract implant kit comprises a scaffold and the gradable detachable digestive tract implant cannula, and the proximal end of the gradable detachable digestive tract implant cannula is connected to the scaffold. When the cannula provided by the present application becomes obstructed, a rear end portion of the cannula can automatically undergo graded detachment in response to intestinal peristaltic forces, thereby avoiding intestinal obstruction caused by the obstruction of the cannula and thus significantly improving the safety of the instrument implanted in the body.

Description

Gradable detachable digestive tract implantation sleeve and digestive tract implantation set

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the Chinese patent application filed with the China Patent Office on January 29, 2024, with application number 202410126018.X and titled “Gradable detachable digestive tract implant sleeve and digestive tract implant kit,” the entire contents of which are incorporated by reference into this application. Technical Field

[0003] The present application relates to the field of medical devices, and in particular to a graded detachable digestive tract implant sleeve and a digestive tract implant kit. Background Art

[0004] Globally, obesity costs a staggering 10 trillion RMB annually, equivalent to approximately 2.8% of global GDP. In the United States, obesity-related health care costs account for nearly 17% of all healthcare expenditures. According to obesity data published in The Lancet in 2021, 34.3% of adults aged 18 and over are overweight, and 16.4% are obese, totaling 50.7%. This represents over 200 million obese people in China and over 700 million globally. Furthermore, 80-90% of obese individuals have type 2 diabetes. According to data released by the International Diabetes Federation in December 2021, 537 million adults aged 20-79 currently have diabetes, representing 10.5% of the global population in this age group. This number is projected to rise to 643 million (11.3%) by 2030 and to 783 million (12.2%) by 2045. According to the IDF and numerous domestic publications, type 2 diabetes is the most common type of diabetes, accounting for approximately 90% of all diabetes cases worldwide. At the same time, diabetes has led to a significant increase in global health expenditures. Health expenditures for adults aged 20-79 have increased from $232 billion in 2007 to $966 billion in 2021, with the future market size projected to be in the trillions of dollars. Diabetes has become the third largest non-communicable disease after cardiovascular disease and cancer, with the number of patients increasing annually. It has become a global public health issue threatening human health, necessitating an urgent need for medical technologies to address these challenges.

[0005] The pathogenesis of type 2 diabetes remains incompletely understood. Even with existing oral medications and insulin therapy, many patients still experience poor blood sugar control and are unable to effectively manage the development and progression of complications. Consequently, there is currently no effective cure. While bariatric surgery is highly effective for these conditions, it carries irreversible physiological changes and a high mortality rate, as well as postoperative complications such as gastrointestinal leakage, anastomotic stenosis, and dumping syndrome. Since 2008, GIDynamics, a US company, has developed the duodenal jejunal cannula (DJBL), drawing on the principles of RYGB (a metabolic surgery procedure). This cannula inserts a cannula into the duodenum and proximal jejunum, isolating chyme from the intestinal wall. Nutrients enter the stomach and then pass through the cannula into the proximal jejunum. Pancreatic juice and bile naturally flow downward between the cannula and the intestinal wall, mixing with chyme in the distal DJBL (i.e., the jejunum) to reduce absorption and effectively treat obesity and type 2 diabetes.

[0006] Forner et al. found that the Endobarrier developed by GIDynamics in the United States was found to have device obstruction after implantation in 5% of patients [Obes Surg 27(12):3306-3313]. Device obstruction can lead to premature device removal in mild cases, or intestinal obstruction in severe cases, leading to intestinal folding. Intestinal folding usually requires immediate surgical treatment, otherwise it can threaten life safety or even lead to death. Therefore, it is crucial to reduce the incidence of obstruction of this type of device and improve the safety of implanted devices.

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

[0008] Summary of the Invention

[0009] The purpose of the present application includes, for example, providing a staged detachable digestive tract implant sleeve and a digestive tract implant kit, aiming to improve at least one problem mentioned in the background art.

[0010] The embodiments of the present application can be implemented as follows:

[0011] In a first aspect, the present application provides a graded detachable digestive tract implant sleeve, characterized in that the sleeve has a length of 60 to 150 cm, has a proximal end and a distal end, and is provided with at least one low stress portion 30 to 120 cm from the proximal end of the sleeve;

[0012] The low-stress portion can respond to the peristaltic force of the intestine. When blockage occurs, the low-stress portion may be broken, causing the portion of the sleeve from the broken portion to the distal end to automatically fall off.

[0013] In an optional embodiment, the fracture stress of the low stress portion is 1-12N.

[0014] In an optional embodiment, there are multiple low stress locations, and the multiple low stress locations are evenly distributed along the length direction of the casing.

[0015] In an optional embodiment, the stresses of the multiple low-stress locations are designed to be gradient; the fracture stresses of the multiple low-stress locations decrease successively along the length direction of the casing.

[0016] In an optional embodiment, the stress gradient of the gradient design of the low stress portion is at least 1N.

[0017] In an optional embodiment, the material of the sleeve is selected from at least one of PTFE, FEP, ePTFE, PU, ​​LDPE, LLDPE and PE.

[0018] In an optional embodiment, the wall thickness of the sleeve is 0.01-0.05 mm.

[0019] In an optional embodiment, each low-stress location includes a body that is a part of the sleeve, and a circle of broken imaginary lines arranged on the body along the circumference of the body, and the broken imaginary lines are composed of a plurality of broken through holes arranged at intervals.

[0020] In an alternative embodiment, the broken dashed lines may be formed by laser etching, punching, dashed line cutting knife cutting, or vibrating knife cutting.

[0021] In a second aspect, the present application provides a digestive tract implant kit, comprising a stent and a graded detachable digestive tract implant sleeve as described in any one of the aforementioned embodiments, wherein the proximal end of the graded detachable digestive tract implant sleeve is connected to the stent.

[0022] The beneficial effects of the embodiments of the present application include, for example:

[0023] The graded detachable digestive tract implant sleeve provided in the present application can, due to the setting of the low-stress portion, respond to the peristaltic force of the intestine and break when device obstruction occurs, causing partial detachment of the sleeve, thereby avoiding intestinal obstruction caused by device obstruction and greatly improving the safety of the device implanted in the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application 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.

[0025] FIG1 is a schematic diagram of the structure of the sleeve and the bracket provided in an embodiment of the present application;

[0026] FIG2 is a schematic diagram of the experimental example simulating intestinal obstruction.

[0027] Icons: 100-cannula; 101-proximal end; 102-distal end; 110-low stress area; 111-fracture dotted line; 200-stent; 300-simulator; 301-adjustable valve; 302-placement port. DETAILED DESCRIPTION

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Generally, the components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0029] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for protection, but merely represents selected embodiments of the present application. All other embodiments obtained by persons of ordinary skill in the art based on the embodiments in the present application without creative work are within the scope of protection of the present application.

[0030] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0031] In the description of this application, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. appear, the orientation or position relationship indicated is based on the orientation or position relationship shown in the accompanying drawings, or is the orientation or position relationship in which the product of the application is usually placed when in use. It is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it cannot be understood as a limitation on this application.

[0032] In addition, the terms "first", "second", etc., if used, are merely used to distinguish and describe, and should not be understood as indicating or implying relative importance.

[0033] It should be noted that, in the absence of conflict, the features in the embodiments of this application can be combined with each other.

[0034] Referring to FIG1 , the present embodiment provides a graded detachable digestive tract implant sleeve 100 . The sleeve 100 has a length of 60 to 150 cm and has a proximal end 101 and a distal end 102 . At least one low-stress portion 110 is provided on the sleeve 100 at a distance from the proximal end 101 .

[0035] The low stress portion 110 can respond to the peristaltic force of the intestine. When a blockage occurs, the low stress portion 110 may be broken, causing the portion of the sleeve 100 from the broken portion to the distal end 102 to automatically fall off.

[0036] The graded detachable digestive tract implant sleeve 100 provided in the present application can respond to the peristaltic force of the intestine when device obstruction occurs due to the specific setting of the low stress portion 110. The low stress portion 110 breaks after being stressed, causing the portion of the sleeve 100 from the broken portion to the distal end 102 to automatically fall off, thereby avoiding intestinal obstruction caused by device obstruction, thereby greatly improving the safety of the device implanted in the body.

[0037] The proximal end 101 refers to the end close to the duodenal bulb during implantation, and the distal end 102 refers to the end away from the duodenal bulb.

[0038] Optionally, the fracture stress of the low stress portion 110 is 1-12N.

[0039] When the fracture stress of the responsive portion 110 is within the range of 1 to 12 N, it can be achieved that when device obstruction occurs, the low stress portion 110 fractures under the action of intestinal peristalsis.

[0040] Preferably, in order to fully ensure that intestinal obstruction is avoided when instrument obstruction occurs, there are multiple low-stress locations 110 , and the multiple low-stress locations 110 are evenly distributed along the length direction of the sleeve 100 .

[0041] Furthermore, the fracture stress of the plurality of low stress locations 110 decreases successively along the length direction of the sleeve 100 , that is, the lower the location, the easier it is to fracture.

[0042] For example, the stresses of the multiple low-stress locations 110 are designed to be gradient; the fracture stress decreases sequentially along the length direction of the casing 100 .

[0043] Furthermore, the stress gradient of the low stress portion is designed to be at least 1 N. For example, two, three, or four low stress portions 110 are provided, and the fracture stress of the preceding portion is 1 N, 2 N, or 3 N greater than that of the following portion.

[0044] Specifically, the material of the sleeve 100 is selected from at least one of PTFE (polytetrafluoroethylene), FEP (perfluoroethylene propylene copolymer), ePTFE (expanded polytetrafluoroethylene), PU (polyurethane), LDPE (low-density polyethylene) and LLDPE (linear low-density polyethylene).

[0045] Furthermore, each low stress portion 110 includes a body that is a part of the sleeve 100 and a broken imaginary line 111 arranged along the circumference of the body. The broken imaginary line 111 is composed of a plurality of broken through holes arranged at intervals.

[0046] The broken dotted line 111 is a method of realizing a low stress portion 110 that is more convenient for regulating the fracture stress. By regulating the size of the fracture through-holes or the spacing between the fracture through-holes, different fracture stresses can be regulated. For example, the larger the fracture through-holes and the larger the spacing between the fracture through-holes, the smaller the fracture stress, and vice versa.

[0047] It should be noted that although the broken through-holes are provided, since the chyme is composed of large particles and a high-viscosity fluid, there is no need to worry about the leakage of the chyme as long as the aperture of the through-hole is not too large.

[0048] Furthermore, to ensure the service strength of the sleeve 100 , the wall thickness of the fracture through hole of the sleeve 100 is 0.01 to 0.05 mm.

[0049] Furthermore, the broken dashed line 111 can be formed by laser etching, punching, dashed line cutting knife cutting or vibration knife cutting.

[0050] The embodiment of the present application further provides a digestive tract implant kit, comprising a stent 200 and a graded detachable digestive tract implant sleeve 100 provided in the embodiment of the present application, wherein the proximal end 101 of the graded detachable digestive tract implant sleeve 100 is connected to the stent 200 .

[0051] Example 1

[0052] The sleeve 100 provided in this embodiment has a total length of 60 cm and is provided with a dotted fracture line 111 40 cm from the proximal end 101. The fracture stress of the dotted fracture line 111 is approximately 4 N. The sleeve 100 is entirely made of LDPE and has a wall thickness of approximately 0.02 mm. The low-stress area 110 is cut using a dotted-line cutting knife.

[0053] Example 2

[0054] The sleeve 100 provided in this embodiment has a total length of 100 cm and is provided with a circle of imaginary fracture lines 111 at 80 cm and 90 cm from the proximal end 101. The fracture stresses of the two circles of imaginary fracture lines 111 from the proximal end 101 to the distal end 102 are approximately 7 N and 4 N, respectively. The sleeve 100 is entirely made of an LDPE / LDPE composite material with a wall thickness of approximately 0.02 mm. The low-stress area 110 is formed by stamping.

[0055] Example 3

[0056] The cannula 100 provided in this embodiment has a total length of 150 cm and is provided with a circle of imaginary fracture lines 111 at 90 cm, 120 cm, and 140 cm from the proximal end 101. The fracture stresses of the three circles of imaginary fracture lines 111 from the proximal end 101 to the distal end 102 are approximately 12 N, 8 N, and 3 N, respectively. The cannula 100 is entirely made of an ePTFE / FEP composite material with a wall thickness of approximately 0.01 mm. The low-stress areas 110 are created by laser etching.

[0057] Example 4

[0058] The cannula 100 provided in this embodiment has a total length of 60 cm and is provided with a circle of imaginary fracture lines 111 at 40 cm and 50 cm from the proximal end 101. The fracture stresses of the imaginary fracture lines 111 are approximately 8 N and 3 N, respectively. The cannula 100 is entirely made of polyurethane (PU) and has a wall thickness of approximately 0.02 mm. The low-stress area 110 is cut using a vibrating knife.

[0059] Comparative Example

[0060] This comparative example is substantially the same as Example 1, except that the low stress portion 110 is not provided.

[0061] Experimental example

[0062] When the cannula 100 is blocked, it is pulled by the peristaltic forces within the duodenum. According to research by Gregerson et al., the maximum peristaltic pressure can reach 80 mmHg (108.8 cmH2O) (Gregerson, H., et al. Essentials of experimental surgery: Gastroenterology. CRC Press, 1996). When the cannula 100 is blocked, the low-stress portion ruptures under the pull of duodenal peristalsis. After rupture, the distal end 102 of the cannula 100 is expelled from the body with intestinal peristalsis. However, the low-stress portion 110 should be able to withstand normal intestinal peristalsis when the cannula is not blocked. Based on this principle, a simulated intestinal blockage generator was designed to simulate the detachment effect of the detachable gastrointestinal cannula 100 provided in this application when the gastrointestinal cannula 100 is blocked, as shown in Figure 2. The simulator 300 can provide a certain pressure difference H and also has an adjustable valve 301 and a placement port 302 for the gastrointestinal implant kit provided in this application.

[0063] As shown in FIG2 , the adjustable valve 301 is closed and water is injected into the device until the water level reaches approximately 2 cm from the placement port 302. The membrane tube of the cannula 100 is then tightly closed with thread to simulate blockage. The digestive tract set consisting of the graded detachable digestive tract cannula 100 provided in Examples 1-4 and the cannula provided in the comparative example is placed in the placement port 302. Water is gradually injected into the cannula 100 (note that before injecting water into the cannula 100, ensure that the outer tube is already filled with water). Various amounts of water are then injected to adjust the pressure difference to 100 cmH₂O. The adjustable valve 301 is then opened, and the pressure difference at which the low-stress portion 110 fractures is recorded. For cannula 100 with multiple low-stress portions 110, the location of the fracture is recorded.

[0064] The experimental results are shown in Table 1.

[0065] Table 1 Record of whether each embodiment and comparative example is broken

[0066] As can be seen from Table 1, the sleeves 100 provided in various embodiments of the present application all fell off in the mechanical obstruction environment of the simulator 300, indicating that these sleeves 100 can effectively avoid intestinal obstruction caused by device obstruction after being implanted in the intestine, thereby greatly improving the safety of the device implanted in the body;

[0067] In the comparative example, no fracture or shedding occurs because the low stress portion 110 is not provided. This indicates that the provided low stress portion 110 should have a lower fracture stress, otherwise it is difficult to achieve fracture or shedding of the casing 100 .

[0068] In summary, the graded detachable digestive tract implant sleeve 100 provided in the embodiment of the present application, when device obstruction occurs, due to the setting of the low stress portion 110, the low stress portion 110 can respond to the peristaltic force of the intestine and break, and the rear end portion of the sleeve 100 falls off, which can avoid intestinal obstruction caused by device obstruction, thereby greatly improving the safety of the device implanted in the body.

[0069] The above are only specific embodiments of the present application, but the scope of protection of this application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in this application should be included in the scope of protection of this application. Therefore, the scope of protection of this application should be based on the scope of protection of the claims. Industrial Applicability

[0070] The graded detachable digestive tract implant sleeve provided in the present application has a low-stress portion. When device obstruction occurs, the low-stress portion can respond to the peristaltic force of the intestine and break, causing the rear end portion of the sleeve to fall off, thereby avoiding intestinal obstruction caused by device obstruction, thereby greatly improving the safety of the device implanted in the body.

Claims

1. A graded detachable digestive tract implant sleeve, characterized in that: The sleeve has a length of 60 to 150 cm, has a proximal end and a distal end, and is provided with at least one low stress portion 30 to 120 cm away from the proximal end. The low stress portion can respond to the peristaltic force of the intestine, and when a blockage occurs, the low stress portion can be broken, causing the portion of the sleeve from the broken portion to the distal end to automatically fall off.

2. The step-able detachable digestive tract implant sleeve according to claim 1, characterized in that: The fracture stress of the low stress portion is 1 to 12N.

3. The step-able detachable digestive tract implant sleeve according to claim 2, characterized in that: There are multiple low stress locations, and the multiple low stress locations are evenly distributed along the length direction of the casing.

4. The step-able detachable digestive tract implant sleeve according to claim 3, characterized in that: The stresses of the plurality of low stress locations are designed to be gradient; and the fracture stresses of the plurality of low stress locations decrease in sequence along the length direction of the casing.

5. The step-able detachable digestive tract implant sleeve according to claim 4, characterized in that: The stress gradient of the low stress part gradient design is at least 1N.

6. The step-by-step detachable digestive tract implant sleeve according to any one of claims 1 to 5, characterized in that: The material of the sleeve is selected from at least one of PTFE, FEP, ePTFE, PU, LDPE, LLDPE and PE.

7. The step-by-step detachable digestive tract implant sleeve according to any one of claims 1 to 6, characterized in that: The wall thickness of the sleeve is 0.01-0.05 mm.

8. The step-by-step detachable digestive tract implant sleeve according to any one of claims 1 to 7, characterized in that: Each of the low stress locations includes a body that is a part of the sleeve, and a broken imaginary line arranged on the body along the circumference of the body. The broken imaginary line is composed of a plurality of broken through holes arranged at intervals.

9. The step-able detachable digestive tract implant sleeve according to claim 8, characterized in that: The broken dashed lines can be formed by laser etching, punching, dashed line cutting knife cutting or vibrating knife cutting.

10. A digestive tract implant kit, characterized in that: The invention comprises a stent and the graded detachable digestive tract implant sleeve according to any one of claims 1 to 9, wherein the proximal end of the graded detachable digestive tract implant sleeve is connected to the stent.

Images