Digestive tract stent and stent conveying system

Abstract

The alimentary canal stent is provided with a deformable tubular skeleton formed by a plurality of elastic coils, a recovery mechanism, a plurality of developing mechanisms and a macromolecular covering film, the recovery mechanism is arranged at the upper tail end of the tubular skeleton, the plurality of developing mechanisms are distributed on the tubular skeleton, and the macromolecular covering film is arranged on the tubular skeleton. And the developing mechanism and the tubular framework are coated in the macromolecular covering film. The tubular skeleton of the alimentary canal stent is wrapped in the macromolecule covering film and has certain rigidity, the hollow state is still protected even in the duodenum, a chyme channel is formed, and therefore intestinal obstruction is avoided. And the upper section is of a net-shaped structure, so that the duodenum bulb part cannot be damaged. Meanwhile, a developing mechanism and a recycling mechanism are arranged, so that developing can be conveniently carried out in a non-invasive and non-invasive X-ray mode, and recycling is convenient. The stent conveying system is matched with the alimentary canal stent, and the alimentary canal stent can be conveniently conveyed to a working part.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a digestive tract stent and a stent delivery system. Background Art

[0002] Diabetes refers to a metabolic disease characterized by high blood sugar, which is caused by defects in insulin secretion or its biological function, or both. Diabetes can cause chronic damage or dysfunction of various tissues, posing a great threat to people's health. The prevalence of diabetes in my country has reached 12.8%, and there are more than 140 million diabetes patients in my country. my country has included diabetes prevention and treatment in the 15 special actions of the Healthy China Action. According to the plan, by 2030, the diabetes awareness rate of residents aged 18 and above will reach 60% or more; the standardized management rate of diabetic patients will reach 70% or more. Common ways to improve obesity and diabetes are to control diet, increase exercise, and assist with certain drug treatments, which requires long-term persistence of patients, and once diet control and exercise are stopped, it is easy to cause recurrence. Long-term use of drugs or insulin also brings heavy economic burdens and inconveniences to patients. Gastric bypass surgery is a treatment method that has a very good effect on curing type 2 diabetes and improving obesity. It is a surgery that uses surgical means to change the food flow path. Through gastrointestinal anastomosis, intestinal anastomosis, etc., food is allowed to reach the distal end in advance, reduce stimulation, and reduce insulin resistance. In 2001, the International Diabetes Federation officially recommended metabolic surgery (including gastric bypass surgery) as a treatment for obesity and type 2 diabetes. It promotes insulin secretion, thereby achieving a blood sugar lowering effect. However, this surgery has some disadvantages, such as anastomotic leakage, incision infection, pneumonia, bleeding and malnutrition, and more importantly, surgery is irreversible.

[0003] At present, there are also some treatment methods that replace gastric bypass surgery by implanting stent products with a gastric diverter structure in the gastrointestinal tract, that is, replacing surgical treatment with interventional methods to treat diabetes. For example, the product of the American GI company that has been launched on the market has a V-shaped stent with barbs, which is anchored in the form of barbs and fixed in the duodenal bulb. However, this design can easily make the stent difficult to retrieve or cause digestive tract perforation.

[0004] A gastric bypass device product has appeared in China, such as the gastric bypass stent used in duodenal jejunal sleeve (DJBS) surgery. This gastric bypass stent is a membrane sleeve of about 60 cm. The front section of this gastric bypass stent is a metal frame, and the descending section and the rear section are membrane tubes. This gastric bypass stent has the following problems:

[0005] 1. The posterior segment of the descending duodenum and the posterior segment of the gastric bypass stent are unsupported, that is, a segment of polymer membrane tube. With the peristalsis of the gastrointestinal tract, it is easy to cause intestinal obstruction or block the opening of the duodenal papilla, causing serious complications such as acute pancreatitis;

[0006] 2. The polymer membrane tube has no imaging, and its shape and position cannot be determined by non-invasive methods (under X-rays). It can only be observed through endoscopy, which is inconvenient for patients to follow up;

[0007] 3. The design of the metal frame of the ball is unreasonable. The frame is sparse and hard, which is not easy to recover. In order to enhance the anchoring and prevent the stent from shifting due to gastrointestinal peristalsis, barbs are usually designed to enhance the anchoring. The barb structure may also cause serious complications of gastrointestinal perforation and increase the risk of subsequent recovery.

[0008] Therefore, in view of the shortcomings of the prior art, it is necessary to provide a digestive tract stent and a stent delivery system to solve the shortcomings of the prior art. Summary of the invention

[0009] The first object of the present invention is to provide a digestive tract stent that avoids the shortcomings of the prior art. The digestive tract stent is a tubular skeleton that can effectively prevent intestinal obstruction. At the same time, it can be stably anchored in the duodenal bulb without causing damage to the digestive tract, and can be developed by X-rays and is easy to recover.

[0010] The above-mentioned purpose of the present invention is achieved by the following technical measures:

[0011] A digestive tract stent is provided, which is provided with a deformable tubular frame, a recovery mechanism, a plurality of developing mechanisms and a polymer coating, wherein the recovery mechanism is arranged at the upper end of the tubular frame, the plurality of developing mechanisms are distributed on the tubular frame, and the developing mechanisms are inside the polymer coating coated on the tubular frame.

[0012] The tubular skeleton is divided into an upper section for anchoring to the duodenal bulb and a lower section for isolating chyme from the descending duodenum to the proximal small intestine.

[0013] Preferably, the upper section is composed of a plurality of elastic coils interconnected with each other to form an elastic tubular cavity structure for anchoring to the duodenal bulb.

[0014] Preferably, the lower section is composed of a metal wire with a spiral structure, and the metal wire is defined as a spiral metal skeleton, and the spiral metal skeleton constitutes a tubular cavity structure for the passage of chyme.

[0015] Preferably, the spiral metal skeleton is formed by weaving or cutting metal wires, and the spiral metal skeleton has a plurality of alternately connected valleys and peaks.

[0016] Preferably, when the above-mentioned digestive tract stent is in an expanded state, the diameter of the upper section is greater than the diameter of the lower section.

[0017] The elastic coil is woven from one or more metal wires;

[0018] or

[0019] The elastic coil is cut from a metal tube.

[0020] Preferably, the elastic coil has a plurality of alternately connected valleys and peaks, so that the elastic tubular structure cavity has elasticity in the radial direction.

[0021] Preferably, the highest point of the valley of the elastic coil and the lowest point of the peak of the adjacent elastic coil are interconnected to form an elastic tubular cavity structure, and the interconnection is interweaving or connection.

[0022] The valleys of the interconnected elastic coils and the peaks of the adjacent elastic coils are defined as cross-connections.

[0023] The uppermost elastic coil located in the upper section is defined as an upper elastic coil; and the lowermost elastic coil located in the upper section is defined as a lower elastic coil.

[0024] Preferably, the lowest point of the valley of the above-mentioned lower end elastic coil is connected to the highest point of the peak of the uppermost circle of the spiral metal skeleton by weaving or hooking through a metal connecting wire, so that the upper section and the lower section form a whole.

[0025] Preferably, the lower section is divided into a descending sub-section and a rear sub-section, the descending sub-section is located between the upper section and the rear sub-section, and the diameter of the descending sub-section is smaller than the diameter of the rear sub-section.

[0026] Preferably, the above-mentioned developing mechanism is a metal wire with X-ray opaque properties;

[0027] Preferably, the developing mechanism is wound on the metal wire surface of the tubular frame, and the developing mechanism is regularly distributed on the tubular frame.

[0028] The developing mechanism located in the upper section is defined as a first developing mechanism, the number of the first developing mechanisms is 4n, and n is a positive integer, and every four first developing mechanisms are respectively wound around the four interconnected edges.

[0029] The developing mechanism located in the lower section is defined as a second developing mechanism, the number of the second developing mechanisms is 2n, and n is a positive integer, and every two second developing mechanisms are respectively wound around the two sides of the same valley or the same peak of the spiral metal skeleton.

[0030] All the first developing mechanisms are evenly distributed around the center of the elastic tubular cavity structure.

[0031] All the second developing mechanisms are distributed from top to bottom in parallel with the central axis of the tubular cavity structure.

[0032] Preferably, the recovery mechanism is a rope-like structure.

[0033] Preferably, one end of the rope-like structure passes through the valley of the upper elastic coil in sequence and is then tied with the other end to form a closed knot, and at least a portion of the rope-like structure is not covered by the polymer film.

[0034] In the spiral metal skeleton, the pitch is 8 mm to 15 mm, the maximum height of adjacent valleys and peaks is 3 mm to 8 mm, and the diameter of the metal wire in the spiral metal skeleton is 0.1 mm to 0.3 mm.

[0035] In the elastic coil, the interval between two adjacent valleys is 8 mm to 15 mm, the maximum height between adjacent valleys and peaks is 8 mm to 15 mm, and the diameter of the metal wire in the elastic coil is 0.3 mm to 0.6 mm.

[0036] Preferably, the diameter of the upper section is between 3 cm and 4 cm.

[0037] Preferably, the length of the upper section is 2.5 cm to 3 cm, and the length of the lower section is 15 cm to 30 cm.

[0038] Preferably, the material of the elastic coil is nickel-titanium alloy.

[0039] Preferably, the material of the developing mechanism is gold wire, tantalum wire or platinum-iridium alloy wire.

[0040] Preferably, the material of the polymer coating is fluorine-containing plastic, and the fluorine-containing plastic is polytetrafluoroethylene.

[0041] Preferably, the length of the upper section is 2.5 cm to 3 cm.

[0042] Preferably, the length of the lower section is 15 cm to 30 cm.

[0043] A digestive tract stent of the present invention is provided with a deformable tubular skeleton, a recovery mechanism, a plurality of developing mechanisms and a polymer coating, wherein the recovery mechanism is arranged at the upper end of the tubular skeleton, the plurality of developing mechanisms are distributed on the tubular skeleton, and the developing mechanisms and the inside of the tubular skeleton coated with the polymer coating; the tubular skeleton is divided into an upper section for anchoring with the duodenal bulb and a lower section for isolating chyme from the descending part of the duodenum to the proximal small intestine region; the upper section is formed by a plurality of elastic coils interconnected with each other to form an elastic tubular cavity structure for anchoring with the duodenal bulb; the lower section is formed by a metal wire with a spiral structure, and the metal wire is defined as a spiral metal skeleton, and the spiral metal skeleton constitutes a tubular cavity structure for chyme to pass through; the spiral metal skeleton is woven or cut by metal wire material, and the spiral metal skeleton has valleys and peaks that are alternately connected; when the digestive tract stent is in an expanded state, the diameter of the upper section is greater than the diameter of the lower section. The tubular skeleton of the digestive tract stent of the present invention is coated inside the polymer film, and has a certain rigidity. Even in the duodenum, it still protects the hollow state, forming a chyme channel, so that intestinal obstruction will not occur. In addition, the upper section is a mesh structure that will not cause damage to the duodenal bulb. At the same time, it also has a developing mechanism and a recycling mechanism, which is convenient for developing in a non-invasive and non-invasive X-ray manner, and convenient for recycling.

[0044] The second object of the present invention is to avoid the shortcomings of the prior art and provide a stent delivery system for delivering a digestive tract stent. The stent delivery system facilitates the delivery of the alimentary tract stent to the working site.

[0045] The above-mentioned purpose of the present invention is achieved by the following technical measures:

[0046] A stent delivery system for delivering the above-mentioned digestive tract stent is provided, which comprises a sheath assembly and a sliding assembly. The digestive tract stent is sheathed on one end of the sheath assembly, and the one end of the sheath assembly movably passes through the interior of the sliding assembly.

[0047] When the digestive tract stent is transported, the digestive tract stent is shrunk and sleeved on one end of the sheath assembly, and the sliding assembly is located at the periphery of the digestive tract stent.

[0048] When releasing the digestive tract stent, the sliding component slides upward, the digestive tract stent is exposed and unfolded, and then separated from the sheath component.

[0049] Preferably, the sheath assembly is provided with a fixed handle, a sliding rod, a sheath rod and a sheath head, the fixed handle is integrally connected to one end of the sliding rod, the other end of the sliding rod is fixedly connected to one end of the sheath rod, the sheath head is fixedly assembled on the other end of the sheath rod, the digestive tract stent is sleeved on the outer surface of the sheath rod, and the two ends of the digestive tract stent are respectively abutted against the sheath head and the sliding rod; the sliding rod and the sheath rod move as a whole and penetrate the sliding assembly.

[0050] Preferably, the sheath head is provided with a developing ring.

[0051] Preferably, the sliding assembly is provided with a sliding handle and a sheath tube, the sliding handle is fixedly connected to the sheath tube, and the sliding rod and the sheath rod move as a whole and penetrate the sliding handle and the sheath tube in sequence.

[0052] When releasing the digestive tract stent, the sliding handle drives the sheath tube to slide upward along the sliding rod and the sheath rod, so that the digestive tract stent is exposed and unfolded, and then the digestive tract stent is separated from the sheath assembly.

[0053] Preferably, a passage for the guide wire to pass through is provided from top to bottom inside the fixed handle, inside the sliding rod, inside the sheath rod and inside the sheath head.

[0054] A stent delivery system of the present invention is provided with a sheath assembly and a sliding assembly, wherein the digestive tract stent is sleeved on one end of the sheath assembly, and the one end of the sheath assembly is movable and passes through the interior of the sliding assembly. When the digestive tract stent is delivered, the digestive tract stent contracts and is sleeved on one end of the sheath assembly, and the sliding assembly is located at the periphery of the digestive tract stent. When releasing the digestive tract stent, the sliding assembly slides upward, the digestive tract stent is exposed and unfolded, and then separated from the sheath assembly. The stent delivery system of the present invention is matched with the above-mentioned digestive tract stent, and the digestive tract stent can be conveniently delivered to the working site. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] The present invention is further described with reference to the accompanying drawings, but the contents in the accompanying drawings do not constitute any limitation to the present invention.

[0056] Figure 1 Schematic diagram of the digestive tract stent.

[0057] Figure 2 This is a partial enlarged view of the spiral metal skeleton.

[0058] Figure 3 It is a partial enlarged view between the upper section and the lower section.

[0059] Figure 4 for Figure 1A partial enlarged view of the upper middle section.

[0060] Figure 5 for Figure 1 A partial enlarged view of the developing mechanism in the middle.

[0061] Figure 6 Schematic diagram of the cross section of the polymer film and elastic coil.

[0062] Figure 7 This is a diagram of the state of the digestive tract stent in the duodenum.

[0063] Figure 8 A cross-sectional view of the stent delivery system and the digestive tract stent.

[0064] Fig. 9 for Figure 8 A cross-sectional view of the sheath assembly in FIG.

[0065] Fig.10 This is an enlarged view of the sheath head of the stent delivery system.

[0066] Fig.11 for Figure 8 Cross-sectional view of the sliding assembly in FIG.

[0067] exist Figures 1 to 11 Including:

[0068] Digestive tract stent 10,

[0069] Tubular frame 100,

[0070] Upper section 110,

[0071] The lower section 120, the descending section 121, the rear section 122,

[0072] The elastic coil 130, the valley portion 131, the peak portion 132,

[0073] Spiral metal skeleton 140, metal connecting wire 150,

[0074] Recycling Agency 200,

[0075] Development mechanism 300,

[0076] Polymer coating 400,

[0077] Stent delivery system20,

[0078] Sheath assembly 500, fixing handle 510, sliding rod 520, sheath rod 530, sheath head

[0079] 540, channel 550,

[0080] Sliding assembly 600, sliding handle 610, sheath tube 620,

[0081] Stomach 30 , duodenal bulb 40 , descending duodenum 50 , duodenal papilla 60 , horizontal duodenum 70 , and jejunum 80 . DETAILED DESCRIPTION

[0082] The technical solution of the present invention is further described in conjunction with the following embodiments.

[0083] Example 1

[0084] A digestive tract stent 10, such as Figure 1 As shown, a deformable tubular skeleton 100 composed of multiple elastic coils 130, a recovery mechanism 200, multiple developing mechanisms 300 and a polymer coating 400 are provided. The recovery mechanism 200 is arranged at the upper end of the tubular skeleton 100, and the multiple developing mechanisms 300 are distributed on the tubular skeleton 100. The developing mechanisms 300 and the inside of the polymer coating 400 are coated on the tubular skeleton 100.

[0085] The tubular skeleton 100 is divided into an upper section 110 for anchoring to the duodenal bulb 40 and a lower section 120 for isolating chyme from the descending duodenum 50 to the proximal small intestine region.

[0086] The upper section 110 is composed of a plurality of elastic coils 130 interconnected to form an elastic tubular structure for anchoring to the duodenal bulb.

[0087] The lower section 120 is composed of a metal wire with a spiral structure, which is defined as a spiral metal skeleton 140. The spiral metal skeleton 140 forms a tubular structure for the passage of chyme. The spiral metal skeleton 140 is formed by multiple bending or cutting, and has multiple alternately connected valleys and peaks, such as Figure 2

[0088] When the digestive tract stent is in the expanded state, the diameter of the upper section 110 is greater than the diameter of the lower section 120. The diameter of the metal wire of the elastic coil is greater than the diameter of the metal wire of the spiral metal skeleton.

[0089] It should be noted that the upper section 110 and the lower section 120 of the present invention adopt different skeleton structures. The upper section 110 is an elastic tubular structure and the elastic metal wire is thicker, while the lower section 120 is a tubular structure and the spiral metal skeleton 140 is thinner. Therefore, the support strength of the upper section 110 is greater than that of the lower section 120. Moreover, the spiral metal skeleton 140 of the lower section 120 is thinner and has better flexibility than the upper section 110. The advantage of this is that the upper section 110 can be reliably anchored in the duodenal bulb. The lower section 120 can conform to the structure of the duodenal bend very well, and because the elastic coil 130 and the spiral metal skeleton 140 are both inside the polymer coating 400, a certain cylindrical tubular shape can be maintained, allowing chyme to pass through better.

[0090] The elastic coil 130 is woven from one or more metal wires or cut from a metal tube. The elastic coil 130 has a plurality of alternately connected valleys 131 and peaks 132, so that the elastic tubular structure cavity has radial elasticity. The elastic metal wire of the present invention is connected at the head and tail to form a closed coil.

[0091] When the digestive tract stent 10 is in the expanded state, the diameter of the upper section 110 is greater than the diameter of the lower section 120 .

[0092] It should be noted that, when in the digestive tract, the digestive tract stent 10 of the present invention is in the digestive tract, with the end anchored to the duodenal bulb 40 as the upper end and the other end as the lower end, correspondingly defining the orientation of the digestive tract stent 10 .

[0093] The elastic coil 130 is elastic and can be deformed, so as to shrink or stretch, enhance the anchoring and close fit with the duodenal bulb 40, prevent the stent from being displaced due to intestinal peristalsis, and can also recognize more chyme passing through. At the same time, since the upper section 110 is a denser mesh structure, the stress of the stent on the duodenal bulb 40 is dispersed to a larger area without reducing the anchoring force, preventing the stent implantation from causing the patient's discomfort and abdominal pain. The spiral metal skeleton 140 of the lower section 120 of the present invention is a spiral structure, and the middle part forms a tubular structure. At the same time, it can also bend in accordance with the twisted structure of the intestine to reduce the stimulation to the intestine. At the same time, the shape of the elastic coil 130 and the spiral metal skeleton 140 is wavy, so that the digestive tract stent 10 has a certain radial support and the tubular skeleton 100 retention, which can prevent intestinal obstruction. The material of the elastic coil 130 of the present invention is nickel-titanium alloy, which is a superelastic material.

[0094] like Figure 4 and Figure 5 The highest point of the valley 131 of the elastic coil 130 and the lowest point of the peak 132 of the adjacent elastic coil 130 are interconnected to form an elastic tubular cavity structure, wherein the interconnection is interweaving or connection; the valley 131 of the elastic coil 130 and the peak 132 of the adjacent elastic coil 130 interconnected together are defined as an interconnection.

[0095] The elastic coil 130 at the top of the upper section 110 is defined as the upper elastic coil; the elastic coil 130 at the bottom of the upper section 110 is defined as the lower elastic coil; the lowest point of the valley of the lower elastic coil is woven or hooked with the highest point of the peak of the uppermost circle of the spiral metal skeleton 140 through a metal connecting wire 150, so that the upper section 110 and the lower section 120 form a whole, such as Figure 3 .

[0096] like Figure 6As shown, the developing mechanism 300 and the tubular frame 100 of the present invention are coated inside the polymer film 400 to form a sandwich structure, that is, the inner and outer layers are both the developing mechanism 300 and the tubular frame 100 coated with the polymer film 400, which can avoid the metal frame stent directly contacting the inner wall of the intestine, and the polymer film contacts the intestine and chyme. The material of the polymer film 400 of the present invention is preferably fluorine-containing plastic, wherein the fluorine-containing plastic is polytetrafluoroethylene. The good lubricity and non-stickiness of the polytetrafluoroethylene film can also prevent chyme from adhering to the film and causing bacterial infection.

[0097] The lower section 120 of the present invention is further divided into a descending sub-segment 121 and a rear sub-segment 122, wherein the descending sub-segment 121 is located between the upper section and the rear sub-segment 122, and the diameter of the descending sub-segment 121 is smaller than the diameter of the rear sub-segment 122, which prevents the digestive tract stent 10 from blocking the opening of the duodenal papilla 60 and avoiding complications of acute pancreatitis. The diameters of the descending sub-segment 121 and the rear sub-segment 122 are smaller than the intestinal diameter as a whole, so that pancreatic juice and bile can flow smoothly to the distal end of the duodenum and the jejunum 80.

[0098] In the spiral metal skeleton 130, the pitch is 8mm to 15mm, the maximum height between adjacent valleys and peaks is 3mm to 8mm, and the diameter of the metal wire in the spiral metal skeleton 130 is 0.1mm to 0.3mm. In the elastic coil 130, the interval between two adjacent valleys is 8mm to 15mm, the maximum height between adjacent valleys and peaks is 8mm to 15mm, and the diameter of the metal wire of the elastic coil 130 is 0.3mm to 0.6mm. The diameter of the upper section 110 is 3cm to 4cm. The length of the upper section 110 is 2.5cm to 3cm, and the length of the lower section 120 is 15cm to 30cm.

[0099] The diameter of the upper section 110 needs to be larger than the diameter of the duodenum, generally 10% to 15%.

[0100] It should be noted that the diameter of the metal wire of the elastic coil 130 of the upper section 110 of the present invention is different from the diameter of the spiral metal skeleton 140, wherein the diameter of the elastic coil is thicker than the diameter of the spiral metal skeleton 140. The purpose is to ensure that the upper section 110 of the stent can be better anchored in the duodenal bulb 40 to prevent the stent from shifting and causing digestive tract obstruction. At the same time, the lower section 120 ensures that the digestive tract stent 10 has better flexibility and can better conform to the intestinal lumen.

[0101] The recovery mechanism 200 is a rope-like structure; one end of the rope-like structure passes through the valley 131 of the first elastic coil at the upper end in sequence and then is tied with the other end to form a closed knot, and at least a portion of the rope-like structure is not covered by the polymer film 400.

[0102] The developing mechanism 300 is a metal wire that is not transparent to X-rays; the developing mechanism 300 is wound on the metal wire surface of the tubular frame, and the developing mechanism 300 is regularly distributed on the tubular frame, and the developing mechanism 300 is regularly distributed on the frame of the stent. The developing mechanism 300 located in the upper section 110 is defined as a first developing mechanism, the number of the first developing mechanisms is 4n, and n is a positive integer, and every four first developing mechanisms are respectively wound on the four interlinked edges; the developing mechanism 300 located in the lower section 120 is defined as a second developing mechanism 300, the number of the second developing mechanisms is 2n, and n is a positive integer, and every two second developing mechanisms are respectively wound on both sides of the same valley 131 or the same peak 132 of the second elastic coil. All first developing mechanisms are evenly distributed around the center of the elastic tubular structure. All second developing mechanisms are distributed from top to bottom parallel to the central axis of the tubular structure.

[0103] It should be noted that the first developing mechanism of the present invention presents an "X" shape under X-rays, and the second developing mechanism presents a "V" shape under X-rays. The developing mechanism 300 of the present invention has different shapes and distributions in the upper section 110 and the lower section 120, and its function is to intuitively identify the upper section 110 and the lower section 120 in a non-invasive and non-invasive X-ray manner. The present invention determines the position and shape of the stent in the duodenum by the position distribution of the first developing mechanism. The present invention can also determine whether the position and shape of the digestive tract stent 10 in the digestive tract have changed by the spacing and position distribution of the second developing mechanism, and evaluate the risk of intestinal obstruction.

[0104] It should be noted that the preparation of the digestive tract stent 10 of the present invention can be made by coating an inner polymer coating 400 on a mold rod, then covering the already shaped elastic coil 130, and then coating the outer polymer coating 400, and sintering under high temperature and high pressure. When the digestive tract stent 10 needs to be withdrawn, it enters the duodenal bulb 40 through an external special stent recovery system, hooks the recovery mechanism 200, and pulls the digestive tract stent 10 back into the sheath 620 of the external special stent recovery system and withdraws it from the body.

[0105] The tubular skeleton 100 of the digestive tract stent 10 is coated inside the polymer film 400, and has a certain rigidity, and even in the duodenum, it still protects the hollow state, forming a chyme channel 550, so that intestinal obstruction will not occur. In addition, the upper section 110 is a mesh structure that will not cause damage to the duodenal bulb 40. At the same time, it also has a developing mechanism 300 and a recovery mechanism 200, which is convenient for developing in a non-invasive and non-invasive X-ray manner, and convenient for recovery.

[0106] Example 2

[0107] A stent delivery system 20, such as Figure 8As shown, other features are the same as those of Example 1, except that a sheath assembly 500 and a sliding assembly 600 are provided, the digestive tract stent 10 is sleeved on one end of the sheath assembly 500, and one end of the sheath assembly 500 is movable through the interior of the sliding assembly 600.

[0108] When the digestive tract stent 10 is transported, the digestive tract stent 10 is shrunk and sleeved on one end of the sheath assembly 500 , and the sliding assembly 600 is located on the outer periphery of the digestive tract stent 10 .

[0109] When releasing the digestive tract stent 10 , the sliding assembly 600 slides upward, the digestive tract stent 10 is exposed and unfolded, and then separated from the sheath assembly 500 .

[0110] like Fig. 9 and Fig.10 As shown, the sheath assembly 500 is provided with a fixed handle 510, a slide bar 520, a sheath rod 530 and a sheath head 540. The fixed handle 510 is integrally connected with one end of the slide bar 520, the other end of the slide bar 520 is fixedly connected with one end of the sheath rod 530, the sheath head 540 is fixedly assembled on the other end of the sheath rod 530, the digestive tract stent 10 is sleeved on the outer surface of the sheath rod 530, and the two ends of the digestive tract stent 10 are respectively abutted against the sheath head 540 and the slide bar 520; the slide bar 520 and the sheath rod 530 are movable as a whole and penetrate the sliding assembly 600. The sheath head 540 is provided with a developing ring.

[0111] like Fig.11 As shown, the sliding assembly 600 is provided with a sliding handle 610 and a sheath tube 620, the sliding handle 610 is fixedly connected to the sheath tube 620, and the sliding rod 520 and the sheath rod 530 are movable as a whole and penetrate the sliding handle 610 and the sheath tube 620 in sequence. When releasing the digestive tract stent 10, the sliding handle 610 drives the sheath tube 620 to slide upward along the sliding rod 520 and the sheath rod 530, so that the digestive tract stent 10 is exposed and unfolded, and then the digestive tract stent 10 is separated from the sheath assembly 500.

[0112] A channel 550 for the guide wire to pass through is provided from top to bottom inside the fixed handle 510, inside the sliding rod 520, inside the sheath rod 530 and inside the sheath head 540. The diameter of the channel 550 is about 1 mm, and is used to pass the guide wire. The sheath tube 620 is made of a polymer tubing, such as a nylon tube or a fluoroplastic tube. The sheath rod 530 and the sheath head 540 are also made of a polymer tubing, such as a polyetheretherketone (peek) tube or a nylon tube. The sliding rod 520 is a metal tubing, which is fixed by being sleeved on the middle of the sheath rod 530 and filled with glue. The overall length of the sheath tube 620 is about 110 cm, which can be from the mouth to the jejunum, and the outer diameter of the sheath tube is about 9 mm. The sheath head 540 has a relatively smooth surface, and the sheath head 540 can be made of stainless steel or a polymer material, such as Peek or PTFE.

[0113] The implantation process of the stent delivery system 20 of the present invention is as follows:

[0114] 1. Enter the duodenum through an endoscope and conduct a pre-implantation examination;

[0115] 2. From the oral cavity to the duodenum or jejunum 80, a guidewire channel 550 is established, such as a zebra guidewire;

[0116] 3. The sheath core cavity channel 550 of the sheath assembly 500 of the present invention passes through the guide wire, and the fixed handle 510, the slide rod 520, the sheath rod 530 and the sheath head 540 are pushed along the guide wire into the digestive tract to the duodenum or jejunum 80. During the pushing process, the guide wire needs to be tightly held to prevent the guide wire from moving deeper into the digestive tract and damaging the digestive tract when the sheath is pushed;

[0117] 4. The position where the sheath head 540 enters can be determined by endoscopy or X-ray. When reaching the position, fix the fixed handle 510, pull the sliding handle 610 and the sheath tube 620, and release the digestive tract stent 10. During the release process, ensure that the upper section 110 of the digestive tract stent 10 is in the bulb of the duodenum.

[0118] 5. Pull the sheath rod 530 back into the sheath tube 620, and then move the entire stent delivery system 20 outside the body to complete the implantation.

[0119] 6. Finally, an X-ray or endoscopy examination is performed to confirm the implantation of the digestive tract stent 10.

[0120] The stent delivery system 20 is matched with the above-mentioned digestive tract stent 10, and can conveniently deliver the digestive tract stent 10 to the working site.

[0121] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the essence and scope of the technical solution of the present invention.

Claims

1. A digestive tract stent, characterized in that: A deformable tubular frame, a recovery mechanism, a plurality of developing mechanisms and a polymer coating are provided, wherein the recovery mechanism is provided at the upper end of the tubular frame, a plurality of developing mechanisms are distributed on the tubular frame, and the developing mechanisms and the tubular frame are covered inside the polymer coating; The tubular skeleton is divided into an upper section for anchoring with the duodenal bulb and a lower section for isolating chyme from the descending duodenum to the proximal small intestine; The upper section is composed of a plurality of elastic coils interconnected to form an elastic tubular structure for anchoring to the duodenal bulb; The lower section is composed of a metal wire with a spiral structure, and the metal wire is defined as a spiral metal skeleton, and the spiral metal skeleton forms a tubular cavity structure for the passage of chyme; The spiral metal skeleton is formed by weaving or cutting metal wires, and the spiral metal skeleton has a plurality of alternately connected valleys and peaks; When the digestive tract stent is in an expanded state, the diameter of the upper section is greater than the diameter of the lower section.

2. The digestive tract stent according to claim 1, characterized in that: The elastic coil is woven from one or more metal wires; or The elastic coil is cut from a metal tube; The elastic coil has a plurality of alternately connected valleys and peaks, so that the elastic tubular structure cavity has elasticity in the radial direction.

3. The digestive tract stent according to claim 2, characterized in that: The highest point of the valley of the elastic coil and the lowest point of the peak of the adjacent elastic coil are interconnected to form an elastic tubular cavity structure, and the interconnection is interweaving or connection; The valleys of the interconnected elastic coils and the peaks of the adjacent elastic coils are defined as interconnections; The uppermost elastic coil located in the upper section is defined as the upper elastic coil; the lowermost elastic coil located in the upper section is defined as the lower elastic coil; The lowest point of the valley of the lower elastic coil is connected with the highest point of the peak of the uppermost circle of the spiral metal skeleton by weaving or hooking through a metal connecting wire, so that the upper section and the lower section form a whole.

4. The digestive tract stent according to claim 1, characterized in that: The lower section is divided into a descending sub-section and a rear sub-section, the descending sub-section is located between the upper section and the rear sub-section, and the diameter of the descending sub-section is smaller than the diameter of the rear sub-section.

5. The digestive tract stent according to claim 3, characterized in that: The developing mechanism is a metal wire that is opaque to X-rays; The developing mechanism is wound on the metal wire surface of the tubular frame, and the developing mechanism is regularly distributed on the tubular frame; The developing mechanism located in the upper section is defined as a first developing mechanism, the number of the first developing mechanisms is 4n, and n is a positive integer, and every four first developing mechanisms are respectively wound around the four interconnected edges; The developing mechanism located in the lower section is defined as a second developing mechanism, the number of the second developing mechanisms is 2n, and n is a positive integer, and every two second developing mechanisms are respectively wound around the same valley or the same peak of the spiral metal skeleton; All the first developing mechanisms are evenly distributed around the center of the elastic tubular structure; All the second developing mechanisms are distributed from top to bottom in parallel with the central axis of the tubular cavity structure.

6. The digestive tract stent according to claim 3, characterized in that: The recovery mechanism is a rope-like structure; One end of the rope-like structure passes through the valley of the upper elastic coil in sequence and then is tied with the other end to form a closed knot, and at least a portion of the rope-like structure is not covered by the polymer film.

7. The digestive tract stent according to claim 3, characterized in that: In the spiral metal skeleton, the pitch is 8 mm to 15 mm, the maximum height of adjacent valleys and peaks is 3 mm to 8 mm, and the diameter of the metal wire in the spiral metal skeleton is 0.1 mm to 0.3 mm; In the elastic coil, the interval between two adjacent valleys is 8 mm to 15 mm, the maximum height between adjacent valleys and peaks is 8 mm to 15 mm, and the diameter of the metal wire in the elastic coil is 0.3 mm to 0.6 mm; The diameter of the upper section is 3 cm to 4 cm; The length of the upper section is 2.5 cm to 3 cm, and the length of the lower section is 15 cm to 30 cm.

8. The digestive tract stent according to claim 1, characterized in that: The material of the elastic coil is nickel-titanium alloy; The material of the developing mechanism is gold wire, tantalum wire or platinum-iridium alloy wire; The material of the polymer coating is fluorine-containing plastic, and the fluorine-containing plastic is polytetrafluoroethylene; The length of the upper section is 2.5 cm to 3 cm; The length of the lower section is 15 cm to 30 cm.

9. A stent delivery system for delivering the digestive tract stent according to any one of claims 1 to 8, characterized in that: A sheath assembly and a sliding assembly are provided, wherein the digestive tract stent is sleeved on one end of the sheath assembly, and the one end of the sheath assembly movably passes through the interior of the sliding assembly; When the digestive tract stent is transported, the digestive tract stent is shrunk and sleeved on one end of the sheath assembly, and the sliding assembly is located at the periphery of the digestive tract stent; When releasing the digestive tract stent, the sliding component slides upward, the digestive tract stent is exposed and unfolded, and then separated from the sheath component.

10. The stent delivery system according to claim 9, characterized in that: The sheath assembly is provided with a fixed handle, a sliding rod, a sheath rod and a sheath head, the fixed handle is integrally connected with one end of the sliding rod, the other end of the sliding rod is fixedly connected with one end of the sheath rod, the sheath head is fixedly assembled on the other end of the sheath rod, the digestive tract stent is sleeved on the outer surface of the sheath rod, and the two ends of the digestive tract stent are respectively in contact with the sheath head and the sliding rod; the sliding rod and the sheath rod move as a whole and penetrate the sliding assembly; The sheath head is provided with a developing ring; The sliding assembly is provided with a sliding handle and a sheath tube, the sliding handle is fixedly connected to the sheath tube, and the sliding rod and the sheath rod move as a whole and penetrate the sliding handle and the sheath tube in sequence; When releasing the digestive tract stent, the sliding handle drives the sheath tube to slide upward along the sliding rod and the sheath rod, so that the digestive tract stent is exposed and unfolded, and then the digestive tract stent is separated from the sheath assembly; A passage for the guide wire to pass through is arranged from top to bottom inside the fixed handle, inside the sliding rod, inside the sheath rod and inside the sheath head.

Images