Gastric bypass stent

Abstract

The utility model discloses a stomach bypass stent which comprises a stent body and a membrane tube connected to the stent body, a medicine coating is loaded on the membrane tube, medicine is contained in the medicine coating, and the medicine comprises one or more of weight-losing medicine and medicine for treating diabetes mellitus. According to the gastric bypass stent, the weight-losing medicine and / or the medicine for treating diabetes are / is loaded on the peripheral surface of the membrane tube, so that weight losing and diabetes treatment are realized by isolating nutrient substances through the gastric bypass stent, and the effect of the gastric bypass stent can be enhanced through the combined action of the medicines, so that the treatment time is shortened, and the treatment effect is improved. The problems of inflammation, ulcer and the like caused by the fact that the gastric bypass stent is placed in the intestinal tract of a human body for a long time are reduced or avoided.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a gastric bypass stent. Background Art

[0002] Diabetes refers to a metabolic disease characterized by high blood sugar. It is often caused by defects in insulin secretion or its biological function, or both. Diabetes is usually accompanied by obesity and many complications, posing a great threat to people's health. Common ways to improve obesity and diabetes are to control diet, increase exercise, and inject insulin every day. Long-term insulin injections cause inconvenience to patients' lives and bodies.

[0003] The main cause of obesity is that the calorie intake exceeds the calorie expenditure. By reducing the calorie intake or increasing the calorie expenditure, weight can be reduced to achieve the effect of weight loss.

[0004] As early as 2001, the International Diabetes Federation officially recommended metabolic surgery (including gastric bypass surgery) as a treatment for obesity and type 2 diabetes. In many years of clinical practice, it has been found that gastric bypass surgery has a very good effect on curing type 2 diabetes and improving obesity. However, as a surgical operation, gastric bypass surgery will cause irreversible changes to the human body structure.

[0005] At present, there are also methods at home and abroad to simulate gastric bypass surgery by inserting a gastric bypass stent into the gastrointestinal tract to achieve the purpose of treating diabetes and losing weight. The gastric bypass stent in the prior art generally includes a stent and a membrane tube with one end arranged on the stent. The stent is positioned in the duodenal bulb, and the membrane tube is located in the duodenum, which is used to divert gastric effluent from the pylorus to the jejunum to avoid direct digestion, absorption and metabolism of gastric effluent in the duodenum, thereby achieving the purpose of treating obesity and diabetes. However, there is still a problem of long treatment cycle in simulating gastric bypass surgery to treat diabetes and lose weight by using a gastric bypass stent, which makes it easy to cause intestinal wear when the gastric bypass stent is placed in the human intestine for a long time, thereby causing ulcers and other problems. Utility Model Content

[0006] The utility model aims to provide a gastric bypass stent capable of shortening the treatment cycle in view of the problems in the prior art.

[0007] In order to achieve the above purpose, the technical solution adopted by the utility model is:

[0008] A gastric bypass stent comprises a stent and a membrane tube connected to the stent, wherein the membrane tube is coated with a drug coating, the drug coating contains drugs, and the drugs include one or more of weight loss drugs and drugs for treating diabetes.

[0009] Preferably, in the above technical solution, the gastric diversion stent also includes a fixing member connected to the stent and used to position the stent, the fixing member includes an annular support body, and a plurality of fixing anchors densely arranged on the annular support body along the circumferential direction of the annular support body, the annular support body is located above the stent, and the two are fixedly connected by a plurality of connecting rods, and a self-expanding structure is provided on the annular support body so that it has a variable diameter, and the minimum diameter of the annular support body is greater than or equal to the diameter of the stent in a fully expanded state. The gastric diversion stent can be stably positioned by the fixing anchor to prevent it from shifting. The self-expanding structure of the annular support body can fix the annular support body at the position of the pylorus of the stomach, and the annular support body can be compressed and stretched to adapt to the expansion and peristalsis of the stomach.

[0010] The above technical solution is further preferred, wherein the annular support body comprises a main body and a plurality of spacers spaced apart on the main body, wherein the main body is composed of non-spring wires for providing support force, each of the spacers is composed of spring wires and forms the self-expanding structure, and the fixing anchor is arranged on the main body. The fixing anchor is arranged on the main body so that the annular support body can provide stable support for the fixing anchor, thereby enabling the fixing anchor to better position the gastric bypass stent and prevent it from shifting.

[0011] In the above technical solution, it is further preferred that the fixing anchor is conical in shape, and the cone head is arranged outward, so that the gastric bypass stent can be better positioned.

[0012] In the above technical solution, it is further preferred that the diameter of the annular support body is 1-10 times the diameter of the stent in a fully expanded state.

[0013] In the above technical solution, the end of the film tube used to connect the stent is a multi-layer structure with two or more layers of film, and the stent and the fixing member are both arranged between the films of different layers of the film tube. In this way, the stent and the fixing member are both coated with film inside and outside, so that after the gastric bypass stent is implanted in the patient's intestine, the stimulation and friction of the stent and the fixing member on the patient's intestine can be reduced.

[0014] In the above technical solution, the drug coating is preferably provided on the entire outer circumference of the membrane tube of the entire length, so that the coating thickness of the drug coating on the membrane tube is relatively small to meet the drug concentration requirements of the drug loading, and the drug is evenly dispersed in the human body and is more easily absorbed by the human body.

[0015] In the above technical solution, preferably, the drug coating further comprises a drug carrier, which is a degradable polymer material, and the degradable polymer material is a combination of one or more selected from polyethylene glycol, polyethylene glycol-polycaprolactone, chitosan, chitin, polylactic acid, polyglycolide, degradable polyurethane, hydrogel and gelatin. The provision of the drug carrier enables the drug to be better combined with the membrane tube, and the release cycle of the drug can also be controlled by the drug carrier.

[0016] Preferably, the release period of the drug in the drug coating is 1 to 6 months. The release period of the drug coating can be controlled by controlling the material and molecular weight of the drug carrier.

[0017] In the above technical solution, preferably, the concentration of each drug in the drug coating is 10 μg / mm 2 ~500μg / mm 2 .

[0018] Due to the application of the above technical scheme, the utility model has the following advantages compared with the prior art: the gastric bypass stent of the utility model carries weight loss drugs and / or drugs for treating diabetes on the membrane tube. In addition to achieving weight loss and treating diabetes by isolating nutrients through the gastric bypass stent itself, the efficacy of the gastric bypass stent can be enhanced through the combined action of drugs, thereby shortening the treatment time, so as to reduce or avoid problems such as inflammation and ulcers caused by the long-term placement of the gastric bypass stent in the human intestine. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a schematic diagram of the structure of the gastric bypass stent of this embodiment;

[0020] Figure 2 is a schematic top view of the annular support body of this embodiment;

[0021] Figure 3 is a front view schematic diagram (enlarged view) of the annular support body of this embodiment;

[0022] Figure 4 This is a schematic diagram of the structure of the membrane tube in the thickness direction after drug loading in this embodiment;

[0023] Figure 5 This is a schematic cross-sectional view of the membrane tube after drug loading in this embodiment.

[0024] Among them: 11, stent; 12, annular support body; 121, fixed anchor; 122, self-expanding structure; 13, connecting rod; 2, membrane tube; 3, drug coating; 31, drug; 32, drug carrier. DETAILED DESCRIPTION

[0025] The technical solution of the utility model will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0026] In the description of the present utility model, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like are based on the directions or positional relationships shown in the accompanying drawings, such as Figure 1 In the figure, the left side direction is "front", the right side direction is "back", the upper side direction is "up", the lower side direction is "down", and the directions perpendicular to the paper plane in the figure are "left" and "right". This is only for the convenience of describing the utility model 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 operate in a specific orientation, and therefore cannot be understood as a limitation of the utility model. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0027] like Figure 1 As shown, the gastric bypass stent of this embodiment includes a stent 11, a fixing member and a membrane tube 2. The fixing member 12 is used to position the stent 11, and one end of the membrane tube 2 is arranged on the stent 1.

[0028] The stent 11 is a mesh tubular structure, which has a certain elasticity and support force. The stent 11 can be formed by weaving metal wires, and the metal wires can be nickel-titanium alloy wires or cobalt-chromium alloy wires. Alternatively, the stent 11 can also be processed by laser engraving technology using nickel-titanium alloy materials. When the gastric bypass stent is implanted in the patient's body, the stent 11 is placed in the duodenal bulb.

[0029] like Figure 1 to Figure 3 As shown, the fixing member includes an annular support body 12 and a fixing anchor 121. The annular support body 12 is located above the stent 11, and the minimum diameter of the annular support body 12 is greater than or equal to the diameter of the stent 11 in a fully expanded state. The diameter of the annular support body 12 can be 1-10 times the diameter of the stent 11. In some specific scenarios, the diameter of the annular support body 12 is preferably 1.5-5 times the diameter of the stent 11. The fixing anchors 121 are densely arranged on the annular support body 12 along the circumferential direction of the annular support body 12. Each fixing anchor 121 extends from the outer surface of the annular support body 12 in a direction away from the axis of the annular support body 12, and the length of the fixing anchor 121 is 0.1-5mm. When the gastric bypass stent is implanted in the patient's body, the fixing anchor 121 can fix the position of the gastric bypass stent in the patient's intestine to prevent displacement.

[0030] Preferably, the fixing anchor 121 is conical in shape, with the cone head facing outward, so that the gastric bypass stent can be better fixed.

[0031] like Figure 2 and Figure 3 As shown, the annular support body 12 has a self-expanding structure 122, so that the annular support body 12 can be repeatedly compressed and stretched. When the gastric bypass stent is implanted in the patient's body, the annular support body 12 is placed at the pylorus of the stomach. The self-expanding structure 122 of the annular support body 12 allows the annular support body 12 to be stretched after the gastric bypass stent is implanted in the patient's body, thereby further fixing the gastric bypass stent to prevent it from shifting. When the stomach expands or peristalsis, the self-expanding structure 122 of the annular support body 12 can be compressed or stretched to adapt to the expansion or peristalsis of the stomach.

[0032] In this embodiment, the annular support body 12 includes a main body and a plurality of spacers spaced apart on the main body, the main body is made of non-spring wires for providing support force, each spacer is made of spring wires and forms a self-expanding structure 122, and the fixing anchors 121 are densely arranged on the main body, so that the annular support body 12 can provide a stable support force to the fixing anchors 121, so that the fixing anchors 121 can position the gastric bypass stent.

[0033] like Figure 3 As shown, the spring wire is bent in the up-down direction, so that when the spring wire is stretched or contracted, the fixing anchor 121 can always be against the stomach wall without displacement, and the positioning of the gastric bypass stent will not be affected.

[0034] The self-expanding structure 122 may also adopt other structural forms and is not limited to the structure given in this embodiment.

[0035] The axis center lines of the annular support body 12 and the bracket 11 extend in the same direction, and the two are connected by a plurality of connecting rods 13. Along the circumferential direction of the annular support body 12, the plurality of connecting rods 13 are evenly spaced.

[0036] The membrane tube 2 is made of polymer materials, including but not limited to pebax, nylon, polytetrafluoroethylene, PP, PE, etc. One end of the membrane tube 2 is connected to the bracket 11 and the fixing part by hot melting, welding, bonding or suturing.

[0037] At least one end of the membrane tube 2 connected to the bracket 11 and the fixing part is a multilayer structure having two or more layers of membrane, and the bracket 11 and the fixing part are both arranged between the membranes of different layers of the membrane tube 2. In this embodiment, one end of the membrane tube 2 connected to the bracket 11 and the fixing part is a double-layer structure having an inner layer and an outer layer, and the bracket 11 and the fixing part are both located between the inner layer and the outer layer of the membrane tube 2, and are respectively combined with the inner layer and the outer layer of the membrane tube 2. Alternatively, the inner and outer surfaces of the bracket 11 and the fixing part can also be coated, and the coating of the inner and outer surfaces can also be connected to one end of the membrane tube 2. This arrangement can avoid damage to the patient's intestine when the gastric bypass bracket is implanted in the patient's intestine.

[0038] Preferably, the diameter of the membrane tube 2 is 10-60 mm, the length of the membrane tube 2 is 15 cm-100 cm, and the thickness of the membrane tube 2 is 1 um-1 mm.

[0039] The film tube 2 contains a substance that can be developed, such as one or more of barium sulfate, tungsten powder, bismuth salt, etc. Therefore, when performing X-ray detection on a patient, the film tube 2 can be clearly observed.

[0040] like Figure 4 and Figure 5 As shown, the drug coating 3 is formed by combining a drug 31 and a drug carrier 32 .

[0041] Drug 31 is a weight loss drug and / or a drug for treating diabetes. In addition to achieving weight loss or treating diabetes by isolating nutrients through the gastric bypass stent itself, the efficacy of the gastric bypass stent can also be enhanced through the combined action of drug 31, thereby shortening the treatment time. Drug 31 includes L-carnitine, fat base, orlistat, cimetidine, prednisolone, gliclazide sustained-release tablets, glimepiride tablets, gliquidone tablets, glipizide tablets, etc.

[0042] The drug carrier 32 is a degradable polymer material, for example, polyethylene glycol, polyethylene glycol-polycaprolactone, chitosan, chitin, polylactic acid, polyglycolide, degradable polyurethane, hydrogel, gelatin, etc.

[0043] When the membrane tube 2 carries one or both of the weight loss drugs and the diabetes treatment drugs, the drug concentration of each drug 31 carried by the membrane tube 2 is 10 μg / mm 2 ~500μg / mm 2 . Preferably 100 μg / mm 2 ~300μg / mm 2 .

[0044] The drug concentration can be controlled by controlling the thickness of the drug coating 3, and can also be controlled by controlling the ratio of the drug 31 to the drug carrier 32, i.e., the degradable polymer material, in the drug solution.

[0045] As the degradable polymer material degrades, the drug 31 is continuously released in the gastrointestinal tract. By adjusting the material and molecular weight of the degradable polymer material, the release period of the drug 31 can be varied from 1 month to 6 months. Table 1 shows the degradation period corresponding to different types of degradable polymer materials and molecular weights.

[0046] Table 1 Degradation cycles of different types of degradable polymers and molecular weights

[0047]

[0048] The drug coating 3 is coated on the outer circumference of the membrane tube 2. Preferably, the drug coating 3 is coated on the entire outer circumference of the membrane tube 2 of the entire length, that is, the entire membrane tube 2 is loaded with the drug coating 3. In this way, the coating thickness of the drug coating 3 on the membrane tube 2 is relatively small to meet the requirements of the drug concentration of the loaded drug, and the drug 31 is evenly dispersed in the human body and is more easily absorbed by the human body. Of course, the drug coating 3 can also be coated on the entire outer circumference of a partial length of the membrane tube 2, or the drug coating 3 can be coated on a portion of the outer circumference of the membrane tube 2 in the circumferential direction.

[0049] The preparation method of the drug coating 3 specifically comprises the following steps:

[0050] (1) The drug carrier 32 is dissolved in a volatile organic solvent to form a polymer solution.

[0051] (2) placing the drug 31 into the polymer solution formed in step (1) and stirring the mixture so that the components of the drug 31 can be evenly dispersed in the polymer solution formed in step (1), thereby forming a drug solution.

[0052] In this step, the drug 31 can be completely dissolved in the polymer solution formed in step (1), or the drug 31 can be suspended in the polymer solution formed in step (1) in the form of small particles.

[0053] When the membrane tube 2 carries both a weight loss drug and a drug for treating diabetes, the two drugs 31 are simultaneously placed in the polymer solution formed in step (1) and mixed evenly.

[0054] (3) The drug solution obtained in step (2) is coated on the outer peripheral surface of the membrane tube 2 by one or more methods including solution spraying, ultrasonic spraying, liquid dipping, and roller coating.

[0055] In order to better combine the membrane tube 2 with the drug coating 3, before loading the drug on the outer surface of the membrane tube 2, the membrane tube 2 with lower surface activity can be firstly subjected to surface activation treatment by an activation instrument, and the treatment time is within 5s-45s, so that the drug coating 3 is better combined with the membrane tube 2. When the drug coating 3 contacts the membrane tube 2, the volatile organic solvent will evaporate, and a mixed coating of degradable polymer material and drug 31 will be formed on the surface of the membrane tube 2.

[0056] The film tube 2 after drug loading is in a wavy folded state before entering the human body, which can effectively reduce the scratching of the drug 31 on the surface of the film tube 2 when the gastric bypass stent is released.

[0057] The above embodiments are only for illustrating the technical concept and features of the utility model, and their purpose is to enable people familiar with this technology to understand the content of the utility model and implement it. They cannot be used to limit the protection scope of the utility model. All equivalent changes or modifications made according to the spirit of the utility model should be included in the protection scope of the utility model.

Claims

1. A gastric bypass stent, comprising a stent and a membrane tube connected to the stent, characterized in that: The membrane tube is provided with a drug coating, wherein the drug coating contains drugs, and the drugs contain one or more of weight loss drugs and drugs for treating diabetes.

2. The gastric bypass stent according to claim 1, characterized in that: The gastric diversion stent also includes a fixing member connected to the stent and used to position the stent, the fixing member includes an annular support body and a plurality of fixing anchors densely arranged on the annular support body along the circumferential direction of the annular support body, the annular support body is located above the stent, and the two are fixedly connected by a plurality of connecting rods, the annular support body is provided with a self-expanding structure so that it has a variable diameter, and the minimum diameter of the annular support body is greater than or equal to the diameter of the stent in a fully expanded state.

3. The gastric bypass stent according to claim 2, characterized in that: The annular support body includes a main body and a plurality of spacers spaced apart on the main body. The main body is made of non-spring wire for providing support force. Each of the spacers is made of spring wire and forms the self-expanding structure. The fixing anchor is arranged on the main body.

4. The gastric bypass stent according to claim 2, characterized in that: The fixing anchor is in a cone shape, and the cone head is arranged outwards.

5. The gastric bypass stent according to claim 2, characterized in that: The diameter of the annular support body is 1-10 times the diameter of the stent in a fully expanded state.

6. The gastric bypass stent according to claim 2, characterized in that: The end of the membrane tube used to connect the support is a multi-layer structure having two or more layers of membranes, and the support and the fixing member are both arranged between different layers of membranes of the membrane tube.

7. The gastric bypass stent according to claim 1, characterized in that: The drug coating is disposed on the entire outer circumference of the film tube over the entire length.

8. The gastric bypass stent according to claim 1, characterized in that: The drug coating also contains a drug carrier, which is a degradable polymer material. The degradable polymer material is a combination of one or more selected from polyethylene glycol, polyethylene glycol-polycaprolactone, chitosan, chitin, polylactic acid, polyglycolide, degradable polyurethane, hydrogel and gelatin.

9. The gastric bypass stent according to claim 1, characterized in that: The release period of the drug in the drug coating is 1 to 6 months.

10. The gastric bypass stent according to claim 1, characterized in that: The concentration of each drug in the drug coating is 10 μg / mm 2 ~500μg / mm 2 .

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