Automatically breaking digestive tract sleeve and kit

Abstract

Provided are an automatically breaking digestive tract sleeve (100) and a kit. The automatically breaking digestive tract sleeve (100) has a length of 60-150 cm. The sleeve (100) comprises a proximal end (101) and a distal end (102). At least one degradable tube section (110) made of a degradable material is arranged on the sleeve (100) at a position 30-120 cm from the proximal end (101). The digestive tract implantation kit comprises a support (200) and the sleeve (100). The provided sleeve (100) effectively prevents intestinal obstruction caused by device blockage, thereby significantly improving the safety of in vivo device implantation.

Description

Automatic Breakaway Digestive Tract Cannulas and Sets

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to Chinese patent application number 202410125123.1, filed with the Patent Office of China on January 29, 2024, entitled “Automatic Breaking Digestive Tract Sleeve and Set,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present application relates to the field of medical device technology, and in particular to an automatically breaking digestive tract cannula and sleeve. Background Art

[0004] There are currently many obese patients in the world. Relevant scientific experiments have shown that excessive obesity can cause a series of diseases, such as diabetes. According to data released by the International Diabetes Federation in December 2021, there are currently 537 million adults aged 20-79 with diabetes, accounting for 10.5% of the global population in this age group.

[0005] Since 2008, GIDynamics, a US company, has developed the duodenal jejunal cannula (DJBL), drawing on the principles of RYGB (a metabolic surgery procedure). This method involves inserting 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 are naturally secreted, flowing downward between the cannula and the intestinal wall, mixing with chyme in the distal DJBL (i.e., the jejunum), reducing absorption and serving the purpose of treating obesity and type 2 diabetes. However, studies have found that there is a certain probability (approximately 5%) of device obstruction after cannula implantation. This can lead to premature device removal in mild cases, or even intestinal obstruction and in severe cases, intestinal folding. Therefore, improving the safety of cannula implantation is crucial.

[0006] In view of this, this application is hereby filed.

[0007] Summary of the Invention

[0008] The purpose of the present application is to provide an automatically ruptured digestive tract sleeve and a set, aiming to improve at least one problem existing in the background technology.

[0009] This application is implemented as follows:

[0010] In a first aspect, the present application provides an automatically breaking digestive tract sleeve, the sleeve having a length of 60 to 150 cm, the sleeve having a proximal end and a distal end, and at least one degradable tube segment made of a degradable material on the sleeve at a distance of 30 to 120 cm from the proximal end.

[0011] In an optional embodiment, the degradable material includes at least one of poly (DL-lactide-glycolide), polyglycolide-polycaprolactone, poly (L-lactide-co-ε-caprolactone), poly (L-lactic acid), poly (L-lactic acid-trimethyl chitosan) and polydioxanone.

[0012] In an optional embodiment, after the sleeve is implanted in the digestive tract, the expected degradation time of the degradable tube segment is 30 to 270 days.

[0013] In an optional embodiment, there are multiple degradable tube segments, and the multiple degradable tube segments are evenly distributed along the length direction of the sleeve.

[0014] In an optional embodiment, the preset degradation time of the plurality of degradable tube segments decreases sequentially from the proximal end to the distal end.

[0015] In an optional embodiment, the material of other parts of the sleeve except the degradable tube section is selected from at least one of PTFE, FEP, ePTFE, PU, ​​LDPE, LLDPE and PE.

[0016] In an optional embodiment, the wall thickness of the sleeve is 0.01-0.05 mm.

[0017] In an optional embodiment, the degradable tube section is connected to other parts of the casing by rolling or welding.

[0018] In an alternative embodiment, the welding is laser welding or RF welding.

[0019] In a second aspect, the present application provides a digestive tract implant kit, comprising a stent and an automatically rupturing digestive tract sleeve as described in any one of the aforementioned embodiments, wherein the proximal end of the automatically rupturing digestive tract sleeve is connected to the stent.

[0020] This application has the following beneficial effects:

[0021] The automatic breaking digestive sleeve obtained by the above design has at least one degradable tube section, which makes the sleeve degrade and break in the digestive tract environment after being implanted in the intestine for a period of time, and the section of the tube from the degradation site to the distal end falls off; the preset degradation time is before the possible occurrence of device obstruction, and the tube section close to the distal end falls off, which can effectively avoid the occurrence of intestinal obstruction due to device obstruction; or, even if it is not completely degraded before the device obstruction, due to the degradation of part of the degradable tube section, its mechanical properties deteriorate, and when the device obstruction occurs, it can also break and fall off under the action of intestinal peristalsis. Therefore, the sleeve provided in the embodiment of the present application can well avoid the occurrence of intestinal obstruction due to device obstruction, thereby greatly improving the safety of the device implanted in the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] 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.

[0023] FIG1 is a schematic diagram of the structure of the sleeve and the bracket provided in an embodiment of the present application;

[0024] FIG2 is a schematic diagram of the experimental example simulating intestinal obstruction.

[0025] Icon: 100-cannula; 101-proximal end; 102-distal end; 110-degradable tube segment; 200-stent; 300-simulator; 301-adjustable valve; 302-placement port. DETAILED DESCRIPTION

[0026] To make the purpose, technical solutions and advantages of the examples of the present application clearer, the technical solutions in the examples of the present application will be described clearly and completely below. Where specific conditions are not specified in the examples, conventional conditions or conditions recommended by the manufacturer are used. Where the manufacturer of the reagents or instruments is not specified, they are all conventional products that can be purchased commercially.

[0027] The features and performance of the present application are further described in detail below with reference to the embodiments.

[0028] The following is a detailed description of the automatic breaking digestive tract sleeve 100 and its set provided in the present application.

[0029] The automatically rupturing digestive tract sleeve 100 provided in the embodiment of the present application has a length of 60 to 150 cm. The sleeve 100 has a proximal end 101 and a distal end 102 . The sleeve 100 has at least one degradable tube segment 110 made of a degradable material at a distance from the proximal end 101 .

[0030] The sleeve 100 provided in the embodiment of the present application has at least one degradable tube segment 110, so that after the sleeve 100 is implanted in the intestine for a period of time, the degradable sleeve 100 degrades and breaks in the digestive tract environment, and the tube segment from the degradation site to the distal end 102 falls off; the preset degradation time is before the possible occurrence of device obstruction, and the tube segment close to the distal end 102 falls off, which can effectively avoid intestinal obstruction caused by device obstruction; or, even if it is not completely degraded before device obstruction, due to the partial degradation of the degradable tube segment 110, its mechanical properties deteriorate, and when device obstruction occurs, it can also break and fall off under the action of intestinal peristalsis.

[0031] Therefore, the sleeve 100 provided in the embodiment of the present application can effectively avoid intestinal obstruction caused by device obstruction, thereby greatly improving the safety of device implantation in the body.

[0032] Specifically, the degradable material includes at least one of poly (DL-lactide-glycolide), polyglycolide-polycaprolactone, poly (L-lactide-co-ε-caprolactone), poly (L-lactic acid), poly (L-lactic acid-trimethyl chitosan) and polydioxanone.

[0033] Different degradable materials have different degradation times in the intestinal environment. According to the preset degradation time, a single degradable material or a combination of multiple degradable materials can be selected to form the degradable tube segment 110.

[0034] Generally speaking, the peak time for device obstruction after implantation of the cannula 100 is within 15-180 days after implantation. Considering the decrease in mechanical properties of the degradable tube segment after degradation, the expected degradation time of the degradable tube segment 110 can be set to 30-270 days.

[0035] Preferably, after the sleeve 100 is implanted in the digestive tract, the expected degradation time of the degradable tube segment 110 is 60-210 days.

[0036] Furthermore, there are multiple degradable tube segments 110, which are evenly distributed along the length of the sleeve 100. When there are multiple degradable tube segments 110, they will be divided into multiple small tube segments after breaking, which can better avoid the occurrence of intestinal obstruction.

[0037] Preferably, the preset degradation time of the plurality of degradable tube segments 110 decreases sequentially from the proximal end 101 to the distal end 102 .

[0038] The tube section near the distal end 102 falls off first, and the tube section near the proximal end 101 falls off later, which can effectively avoid the occurrence of intestinal obstruction and ensure that the longest possible tube can provide weight loss services in the digestive tract.

[0039] Furthermore, the material of other parts of the sleeve 100 except the degradable tube section 110 is selected from at least one of PTFE, FEP, ePTFE, PU, ​​LDPE, LLDPE and PE.

[0040] Furthermore, to ensure that the sleeve 100 has suitable mechanical properties, its wall thickness is 0.01-0.05 mm.

[0041] Furthermore, the degradable tube section 110 is connected to other parts of the sleeve 100 by rolling or welding.

[0042] Specifically, the welding is laser welding or RF welding.

[0043] The digestive tract implant kit provided in the present application includes a stent 200 and an automatically ruptured digestive tract sleeve 100 provided in the present application, wherein the proximal end 101 of the automatically ruptured digestive tract sleeve 100 is connected to the stent 200 .

[0044] Example 1

[0045] The cannula 100 provided in this embodiment is 60 cm long, and a degradable tube segment 110 is provided 30 cm away from the proximal end 101. The length of the degradable tube segment 110 is 0.5 cm, and its material is a mixture of poly(L-lactide-co-ε-caprolactone) and poly(DL-lactide-glycolide) in a ratio of 8:2. The preset degradation time after implantation is 120 days.

[0046] The material of the sleeve 100 except the degradable tube section 110 is PTFE, and the thickness of the sleeve 100 is 0.016 mm.

[0047] Example 2

[0048] The cannula 100 provided in this embodiment is 100 cm long. A degradable tube section 110 is provided at a distance of 30 cm from the proximal end 101. The length of the degradable tube section 110 is 0.5 cm. The material of the degradable tube section 110 is polydioxanone (PDO). The preset degradation time after implantation is 180 days. A degradable tube section 110 is provided at a distance of 60 cm from the proximal end. The length of the degradable tube section 110 is 0.5 cm. The material of the degradable tube section 110 is a mixture of poly(L-lactide-co-ε-caprolactone) and poly(DL-lactide-glycolide) (mass ratio is 1:1). The preset degradation time after implantation is 100 days.

[0049] The material of the sleeve 100 except the degradable tube section 110 is LDPE / LLDPE, and the wall thickness of the sleeve 100 is 0.02 mm.

[0050] Example 3

[0051] The sleeve 100 provided in this embodiment has a length of 150 cm. A degradable tube section 110 is provided at a distance of 40 cm from the proximal end 101. The length of the degradable tube section 110 is 0.5 cm. The material of the degradable tube section 110 is a mixture of poly (L-lactic acid-trimethyl chitosan) and poly (DL-lactide-glycolide) (mass ratio is 2:8), and the preset degradation time after implantation is 30 days; a degradable tube section 110 is provided at a distance of 80 cm from the proximal end 101. The length of the degradable tube section 110 is 0.5 cm. The material of the degradable tube section 110 is a mixture of poly (L-lactide-co-ε-caprolactone) and poly (DL-lactide-glycolide) in a ratio of 8:2, and the preset degradation time after implantation is 120 days; a degradable tube section 110 is provided at a distance of 120 cm from the proximal end 101. The length of the degradable tube section 110 is 0.5 cm. The material of the degradable tube section 110 is poly (L-lactic acid), and the preset degradation time after implantation is 270 days.

[0052] The material of the sleeve 100 except the degradable tube section 110 is ePTFE / FEP, and the wall thickness of the sleeve 100 is 0.015 mm.

[0053] Comparative Example

[0054] This comparative example is basically the same as Example 1, except that the casing 100 does not have the degradable tube section 110 .

[0055] Experimental Example 1

[0056] The cannula prepared in Example 1-3 was completely immersed in simulated intestinal fluid (refer to the 2022 edition of the Pharmacopoeia of the People's Republic of China for the preparation method), and oscillated at 40 rpm in a shaker at 37 ± 2 ° C for different times to the set time. Then, the cannula was gently removed from the simulated intestinal fluid, and the surface liquid was absorbed with absorbent paper. The two ends (excluding the degradable tube end) of the cannula (including the degradable tube end) were fixed to the fixture of a computerized material testing machine, and the speed was set to 20 mm / min. The connection force before was measured. When the connection force was less than 2 N, it was considered that the failure time was reached (blockage could cause rapid breakage under intestinal peristalsis pressure), and the immersion time at this time was recorded as the failure time.

[0057] Table 1 The failure time of the degradable pipe segments of each embodiment (days)

[0058] Note: Pipe segments 1 to 3 are sorted from distal to proximal.

[0059] It can be seen from the data in Table 1 that the degradable tube section 110 on the casing 100 provided in the embodiment of the present application can achieve triggering of the failure time and can also realize the design of time gradient difference.

[0060] Experimental Example 2

[0061] When the sleeve 100 is blocked, it will be pulled by the peristaltic force inside the duodenum. According to research by Gregerson et al., the maximum pressure of intestinal peristalsis can reach 80 mmHg (108.8 cmH2O) (Gregerson, H., et al. Essentials of experimental surgery: Gastroenterology. CRC Press, 1996.). When the sleeve 100 is blocked, even if the degradable tube segment 110 is not completely degraded, the partially degraded degradable tube segment 110 breaks under the pulling effect of the duodenal peristalsis, and the pipe near the distal end 102 is discharged from the body along with the intestinal peristalsis. However, the degradable tube segment 110 provided at the same time should be able to withstand the normal peristaltic force of the intestine when the sleeve 100 is not blocked and degrade within the expected time period. Based on this principle, a simulated intestinal blockage generator is designed to simulate the detachment effect of the automatic rupture digestive sleeve 100 provided by this application when the digestive tract sleeve 100 is blocked, as shown in Figure 2. The simulator 300 can provide a certain pressure difference H, and has an adjustable valve 301 and a placement port 302 for placing the digestive tract implant kit provided in this application.

[0062] As shown in Figure 2, close the adjustable valve 301 and inject water into the device until the water level reaches about 2 cm from the placement port 302. Then, the membrane tube of the sleeve 100 is tightly closed with a thread to simulate blockage. The digestive tract set consisting of the automatic rupture type digestive sleeve 100 provided in Example 1 and the comparative example is placed in the placement port 302. Water is gradually injected into the sleeve 100 (note that before injecting water into the sleeve 100, it is necessary to ensure that the outside of the pipe is filled with water). Then, different amounts of water are injected to adjust the pressure difference to 100 cmH2O. After that, the adjustable valve 301 is opened and it is recorded whether it is broken.

[0063] The above experiment was conducted 100 days after Example 1 was implanted in the simulated digestive tract environment. When the cannula 100 had not yet broken, the cannula 100 was placed in the simulator 300 for the simulation experiment. The experimental results are recorded in Table 2.

[0064] Table 2 Record of whether Example 1 and Comparative Example are broken

[0065] It can be seen from Table 2 that even if the device is blocked before the sleeve provided in the embodiment of the present application degrades and breaks, it can still break under the action of the pulling force of intestinal peristalsis.

[0066] In summary, the automatic breaking type digestive sleeve provided in the embodiment of the present application has at least one degradable tube segment, which makes the sleeve degrade and break in the digestive tract environment after being implanted in the intestine for a period of time, and the section of the tube from the degradation site to the distal end falls off; the preset degradation time is before the possible occurrence of device obstruction, and the tube segment close to the distal end falls off, which can effectively avoid the occurrence of intestinal obstruction due to device obstruction; or, even if it is not completely degraded before the device obstruction, due to the degradation of part of the degradable tube segment, its mechanical properties deteriorate, and when the device obstruction occurs, it can also break and fall off under the action of intestinal peristalsis. Therefore, the sleeve provided in the embodiment of the present application can well avoid the occurrence of intestinal obstruction due to device obstruction, thereby greatly improving the safety of the device implanted in the body.

[0067] The above description is merely a preferred embodiment of the present application and is not intended to limit the present application. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application. Industrial Applicability

[0068] The present application provides a graded detachable digestive tract implant sleeve, which has at least one degradable tube segment. This allows the sleeve to be implanted in the intestine for a period of time, and the degradable sleeve will degrade and break in the digestive tract environment, and the section of the tube from the degradation site to the distal end will fall off. The preset degradation time is before the possible occurrence of device obstruction, and the tube segment close to the distal end falls off, which can effectively avoid the occurrence of intestinal obstruction due to device obstruction. Alternatively, even if it is not completely degraded before the device obstruction, due to the degradation of part of the degradable tube segment, its mechanical properties deteriorate, and when the device obstruction occurs, it can also break and fall off under the action of intestinal peristalsis. Therefore, the sleeve provided by the present application can well avoid the occurrence of intestinal obstruction due to device obstruction, thereby greatly improving the safety of the device implanted in the body.

Claims

1. An automatic breaking digestive tract cannula, characterized in that: The length of the sleeve is 60 to 150 cm, and the sleeve has a proximal end and a distal end. The sleeve is provided with at least one degradable pipe section made of degradable material at a distance of 30 to 120 cm from the proximal end.

2. The automatic breaking digestive tract cannula according to claim 1, characterized in that: The degradable material includes at least one of poly (DL-lactide-glycolide), polyglycolide-polycaprolactone, poly (L-lactide-co-ε-caprolactone), poly (L-lactic acid), poly (L-lactic acid-trimethyl chitosan) and polydioxanone.

3. The automatic breaking digestive tract cannula according to claim 1 or 2, characterized in that: After the sleeve is implanted in the digestive tract, the expected degradation time of the degradable tube segment is 30 to 270 days.

4. The automatic breaking digestive tract cannula according to claim 3, characterized in that: There are multiple degradable tube sections, and the multiple degradable tube sections are evenly distributed along the length direction of the sleeve.

5. The automatic breaking digestive tract cannula according to claim 4, characterized in that: The preset degradation time of the multiple degradable tube segments decreases sequentially from the proximal end to the distal end.

6. The automatic breaking digestive tract cannula according to claim 1, characterized in that: The material of other parts of the sleeve except the degradable tube section is selected from at least one of PTFE, FEP, ePTFE, PU, LDPE, LLDPE and PE.

7. The automatic breaking digestive tract cannula according to claim 1, characterized in that: The wall thickness of the sleeve is 0.01-0.05 mm.

8. The automatic breaking digestive tract cannula according to claim 1, characterized in that: The degradable tube section is connected to other parts of the sleeve by rolling or welding.

9. The automatic breaking digestive tract cannula according to claim 8, characterized in that: The welding is laser welding or RF welding.

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

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