Perforated digestive tract implant sleeve and kit

Abstract

The present application relates to the field of medical instruments, and provides a perforated digestive tract implant sleeve and a kit. The length of the sleeve is 60-150 cm. The sleeve comprises a proximal end and a distal end. The sleeve is provided with no more than 7 leakage holes at a distance of 20-140 cm from the proximal end and at least 10 cm from the distal end. The diameter of each leakage hole is 2-20 mm. The sleeve can achieve the isolation of chyme while allowing a very small portion of the chyme to be in contact with an intestinal wall, thereby delaying the onset of compensation function, and greatly improving the therapeutic effect on obesity and type 2 diabetes.

Description

Perforated digestive tract implant sleeves and sets

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to application number 2023118702493 filed with the China Patent Office on December 29, 2023, entitled “Hole-Type Digestive Tract Implant Sleeve and Set,” 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 perforated digestive tract implant sleeve and sleeve. 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 medical expenditures. According to obesity statistics published in The Lancet in 2021, the overweight rate among adults over 18 years old is 34.3%, and the obesity rate is 16.4%, totaling 50.7%. The number of obese people in China has surpassed 200 million, and globally, over 700 million. The increasing prevalence of obesity has become a global public health threat, necessitating the urgent need for medical technologies to address these challenges.

[0005] Current treatments primarily rely on lifestyle interventions, medications, or metabolic surgery. However, these methods have limitations in practical application, such as low compliance, significant trauma, and irreversible damage to physiological structures. In recent years, the duodenal jejunal cannula (DJBS) technique has garnered significant interest among researchers. Drawing on the principles of RYGB gastric bypass (a form of metabolic surgery), DJBS employs a minimally invasive approach by inserting a cannula into the duodenum and upper jejunum through a gastroscope. This diverts food from its usual route through the stomach and duodenum to the small intestine, where it enters the distal jejunum and mixes with bile and pancreatic juice. This isolates the chyme in the proximal duodenum and jejunum from contact with the intestinal wall, reducing absorption.

[0006] Although placing a cannula in the duodenum and proximal jejunum reduces absorption in the short term, over time the jejunum changes its function and gradually compensates, thus affecting the effects of weight and metabolic changes. Based on this, this application is filed.

[0007] Summary of the Invention

[0008] The purpose of the present application includes, for example, providing a perforated digestive tract implant sleeve and a set, aiming to improve at least one problem mentioned in the background art.

[0009] The embodiments of the present application can be implemented as follows:

[0010] In the first aspect, the present application provides a perforated digestive tract implant sleeve, the length of the sleeve is 60 to 150 cm, the sleeve includes a proximal end and a distal end, the sleeve is provided with leakage holes at a distance of 20 to 140 cm from the proximal end and at least 10 cm from the distal end, the number of leakage holes does not exceed 7, and the size of each leakage hole is 2 to 20 mm.

[0011] In an optional embodiment, when there are multiple leakage holes, the leakage holes are distributed in pairs or in unpaired distribution;

[0012] Paired distribution means that all leakage holes are divided into multiple pairs, each pair includes at least two leakage holes located in the same circumferential direction, and each pair of leakage holes is distributed along the length direction of the casing.

[0013] In an optional embodiment, all leakage holes in the same pair are symmetrically or asymmetrically distributed in the same circumferential direction.

[0014] In an optional embodiment, when the leakage holes are not distributed in pairs, the interval between adjacent leakage holes in the length direction of the sleeve is 5 to 300 mm.

[0015] In an optional embodiment, the number of leakage holes is 1 to 6.

[0016] In an optional embodiment, the sum of the areas of all leakage holes is less than or equal to 200 mm2.

[0017] In an optional embodiment, the shape of each leakage hole is regular or irregular;

[0018] Regular shapes include circles, ovals, waists or polygons.

[0019] In an optional embodiment, the material of the sleeve is selected from at least one of PTFE, FEP, ePTFE, PU, ​​LDPE and LLDPE.

[0020] In an optional embodiment, the wall thickness of the sleeve is 0.01-0.03 mm.

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

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

[0023] The perforated digestive tract implant sleeve obtained by the above design has a partial isolation section, and the partial isolation section is provided with a leakage hole, which can isolate the chyme and allow part of the chyme to contact the intestinal wall, thereby stimulating the secretion of GLP-1 more and reducing absorption. It can further delay the time for the intestinal compensatory function to play a role, and greatly improve the treatment effect on obesity and type 2 diabetes. 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 structural diagram of a digestive tract implant kit provided in an embodiment of the present application;

[0026] FIG2 is a statistical diagram of the experimental results of the experimental example.

[0027] Icon: 100-cannula; 101-proximal end; 102-distal end; 111-leakage hole; 200-stent. 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] Please refer to Figure 1. This embodiment provides a perforated digestive tract implant sleeve 100. The length of the sleeve 100 is 60 to 150 cm. The sleeve 100 includes a proximal end 101 and a distal end 102. The sleeve 100 is provided with leakage holes 111 at least 10 cm away from the proximal end 101 and the distal end 102. The number of leakage holes 111 does not exceed 7, and the size of each leakage hole 111 is 2 to 20 mm.

[0035] The perforated digestive tract implant sleeve 100 provided in the embodiment of the present application has a partial isolation section, and a leakage hole 111 is provided on the partial isolation section, which can isolate the chyme and allow part of the chyme to contact the intestinal wall, thereby stimulating the secretion of GLP-1 and reducing absorption. It can further delay the time for the intestinal compensatory function to be exerted, and greatly improve the treatment effect on obesity and type 2 diabetes.

[0036] 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.

[0037] The reason why the leakage hole 111 of the partial isolation section is set more than 20 cm away from the proximal end 101 is that the length of the duodenum is 20-30 cm. When a small amount of chyme leaked from the leakage hole 111 contacts the jejunum, it may be more conducive to the secretion of GLP-1 and produce an effect similar to gastric bypass surgery (Neurogastroenterology & Motility, 2013, 25(1): e70-e79 and PloS one, 2013, 8(6): e65696.); the reason why the aperture of the leakage hole 111 is set to 3-20 mm is that if the aperture is too small, the chyme cannot contact the intestine, and if the aperture is too large, too much chyme will leak out of the sleeve 100 and enter the intestine for digestion and absorption, thereby affecting the effect.

[0038] Optionally, when there are multiple leakage holes 111 , the leakage holes 111 are distributed in pairs or in non-pairs.

[0039] Paired distribution means that all leakage holes 111 are divided into multiple pairs, each pair includes at least two leakage holes 111 located in the same circumferential direction, and each pair of leakage holes 111 is distributed along the length direction of the sleeve 100 .

[0040] Optionally, all leakage holes 111 in the same pair are symmetrically or asymmetrically distributed in the same circumferential direction.

[0041] When the leakage holes 111 are not distributed in pairs, the interval between adjacent leakage holes 111 in the length direction of the sleeve 100 is 5 to 300 mm.

[0042] Specifically, the shape of each leakage hole 111 is regular or irregular; the regular shape may be, for example, circular, elliptical or polygonal.

[0043] When the leakage hole 111 is circular, the aperture refers to its diameter; when the leakage hole 111 is non-circular, the aperture refers to the diameter of the circumscribed circle of the hole.

[0044] Optionally, in order to achieve a better therapeutic effect on obesity and type 2 diabetes, the length of the partial isolation section is 20 to 120 cm, and no more than 7 leakage holes 111 are evenly arranged in the partial isolation section.

[0045] Optionally, the number of leakage holes 111 is 1 to 6.

[0046] The total area of ​​the leakage holes 111 should not be too large, as too large a size may cause the intestine to absorb more chyme than expected. Therefore, preferably, the total area of ​​all the leakage holes 111 is less than or equal to 200 mm. 2 .

[0047] Optionally, 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).

[0048] Optionally, in order to ensure the strength of the sleeve 100 while having appropriate flexibility, the thickness of the sleeve 100 is 0.01-0.05 mm.

[0049] An embodiment of the present application provides a digestive tract implant kit, comprising a stent 200 and a perforated digestive tract implant sleeve 100 provided in an embodiment of the present application, wherein a proximal end 101 of the sleeve 100 is connected to the stent 200 .

[0050] During implantation, the stent 200 is located in the duodenal bulb, and the sleeve 100 is located in the duodenum, i.e., the upper jejunum.

[0051] Example 1

[0052] This embodiment provides a cannula 100 having a length of 60 cm and two leakage holes 111 disposed 40 cm from the proximal end 101. The leakage holes 111 are distributed in pairs along the same circumference of the cannula 100. The leakage holes 111 are 20 cm away from the distal end 102 of the cannula 100. The leakage holes 111 are waist-shaped holes with a length of 15 mm and a width of 5 mm. The total area of ​​the leakage holes 111 is 139.25 mm. 2 .

[0053] The material of the sleeve 100 is LDPE, and its wall thickness is 0.02 mm.

[0054] Example 2

[0055] This embodiment provides a cannula 100 having a length of 100 cm and two non-paired leakage holes 111. The first leakage hole 111 is 60 cm away from the proximal end 101, and the last leakage hole 111 is 39.5 cm away from the distal end 102, i.e., the spacing between the two leakage holes 111 is 5 mm. The leakage holes 111 are circular with a diameter of 10 mm, and the total area of ​​the leakage holes 111 is 157 mm. 2 .

[0056] The sleeve 100 is made of ePTFE / FEP, and its wall thickness is 0.01 mm.

[0057] Example 3

[0058] This embodiment provides a cannula 100 having a length of 150 cm and 6 non-paired leakage holes 111 provided on the cannula 100. The 6 leakage holes 111 are evenly distributed at intervals of 70 mm along the length direction of the cannula 100. The first leakage hole 111 is 80 cm away from the proximal end 101; the last leakage hole 111 is 35 cm away from the distal end 102 of the cannula 100. The leakage holes 111 are circular with a diameter of 5 mm. The total area of ​​the leakage holes 111 is 118 mm. 2 .

[0059] The material of the sleeve 100 is PU, and its wall thickness is 0.03 mm.

[0060] Example 4

[0061] This embodiment provides a sleeve 100 having a length of 80 cm. Four leakage holes 111 are arranged in pairs on the sleeve 100, with two leakage holes 111 in each pair. The first pair of leakage holes 111 is 50 cm away from the proximal end 101, and the last pair of leakage holes 111 is 15 cm away from the distal end 102. The leakage holes 111 in the same pair are symmetrically distributed along the same circumference. The leakage holes 111 are rectangular, 15 mm long and 3 mm wide, and the total area of ​​the leakage holes 111 is 180 mm. 2 .

[0062] The sleeve 100 is made of LDPE / LLDPE composite material, and its wall thickness is 0.05 mm.

[0063] Comparative Example 1

[0064] This comparative example is basically the same as Example 1, except that no leakage hole 111 is provided.

[0065] Comparative Example 2

[0066] This comparative example is basically the same as Example 1, except that a larger number of leakage holes 111 are provided, namely, 8.

[0067] Comparative Example 3

[0068] This comparative example is basically the same as Example 6, with the only difference being that part of the isolation section is disposed 2 cm away from the proximal end.

[0069] Experimental example

[0070] 70 obese patients with similar physical signs (BMI ≥ 35 kg / m 2 ) were divided into seven groups, each with 10 participants. The cannulas provided in Examples 1-4 and Comparative Examples 1-3 were implanted into the digestive tracts of the seven obese patients for three months. The same dietary regimen was used, and monthly weight changes were recorded. Weight loss rates (TWL%) were calculated [(initial weight - observation weight) / initial weight] The results are shown in Figure 2.

[0071] As can be seen from the results in Figure 2, the weight loss rate after implantation of the sleeve 100 provided in Examples 1-4 of the present application is significantly higher than that of each comparative example, indicating that setting the leakage holes 111 defined in the present application in a suitable position on the sleeve 100 is conducive to weight loss.

[0072] In summary, the perforated digestive tract implant sleeve 100 provided in the embodiment of the present application has a partial isolation section, and the partial isolation section is provided with a leakage hole 111, which can isolate the chyme and allow a small amount of chyme to contact the intestinal wall, thereby stimulating the secretion of GLP-1 more and reducing absorption. It can further delay the time for the intestinal compensatory function to play a role, and greatly improve the treatment effect on obesity and type 2 diabetes.

[0073] 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

[0074] The perforated digestive tract implant sleeve provided in the present application has a partial isolation section, and a leakage hole is provided on the partial isolation section, which can isolate the chyme and allow a small amount of chyme to contact the intestinal wall, thereby stimulating the secretion of GLP-1 and reducing absorption. It can further delay the time for the intestinal compensatory function to play a role, and greatly improve the treatment effect on obesity and type 2 diabetes.

Claims

1. A porous digestive tract implantation cannula, characterized in that, The length of the sleeve is 60 to 150 cm. The sleeve includes a proximal end and a distal end. Leakage holes are provided in the sleeve at a distance of 20 to 140 cm from the proximal end and at least 10 cm from the distal end. The number of the leakage holes does not exceed 7, and the size of each leakage hole is 2 to 20 mm.

2. The casing according to claim 1, characterized in that, When the number of the leakage holes is multiple, the distribution mode of the leakage holes is paired distribution or non-paired distribution; The paired distribution means that all the leakage holes are divided into multiple pairs, and each pair includes at least 2 leakage holes located in the same circumferential direction. Each pair of the leakage holes is distributed along the length direction of the sleeve.

3. The casing according to claim 2, characterized in that, All the leakage holes belonging to the same pair are symmetrically distributed or asymmetrically distributed in the same circumferential direction.

4. The casing according to claim 2 or 3, characterized in that, When the leakage holes are non-paired distributed, the distance between adjacent leakage holes in the length direction of the sleeve is 5 to 300 mm.

5. The casing according to any one of claims 1 to 4, characterized in that, The set number of the leakage holes is 1 to 6.

6. The casing according to any one of claims 1 to 5, characterized in that The sum of the areas of all the leakage holes is less than or equal to 200 mm2.

7. The casing according to any one of claims 1 to 6, characterized in that, The shape of each leakage hole is a regular shape or an irregular shape; The regular shape includes a circle, an ellipse, a kidney shape or a polygon.

8. The casing according to any one of claims 1 to 7, characterized in that, The material of the sleeve is selected from at least one of PTFE, FEP, ePTFE, PU, LDPE and LLDPE.

9. The casing according to any one of claims 1 to 8, characterized in that, The wall thickness of the sleeve is 0.01 to 0.05 mm.

10. A digestive tract implant set, characterized in that, It includes a stent and a perforated digestive tract implant sleeve according to any one of claims 1 to 9, and the proximal end of the sleeve is connected to the stent.

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