Gastrointestinal tract magnetic clipping fistulization assembly and application thereof

Abstract

The invention belongs to the technical field of medical instruments, and discloses a gastrointestinal tract magnetic clipping fistulization assembly and application thereof. The assembly comprises at least two magnetic bodies, each magnetic body is provided with a clamping end face, the effective length of each clamping end face is 3-5 cm, the width of each clamping end face is not smaller than 0.2 cm, and a clamping gap of 2-4 mm is formed between the stomach wall and the intestinal wall when the two magnetic bodies are attracted. The assembly can adopt an integral structure, a split structure, a bendable structure or a concave-convex clamping structure, and the magnetic body is provided with a fixing structure and a guide assembly. Laparotomy and minimally invasive implantation are not needed, permanent foreign matter residues are avoided, a stable permanent anastomosis channel can be formed, the risk of complications such as adhesion and leakage is reduced, the device is suitable for patients with refractory digestive tract obstruction, and fistulization safety and success rate are improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a gastrointestinal magnetic clipping fistula assembly and its application. Background Technology

[0002] Gastrointestinal stoma is a key treatment for refractory gastrointestinal obstruction diseases such as gastric outflow tract obstruction and biliary-enteric anastomotic stenosis. Its core purpose is to restore the normal physiological pathway of the digestive tract by establishing an artificial anastomosis between the gastrointestinal tract or between the gastrointestinal tract and other organs, thus resolving problems such as difficulty eating, accumulation of digestive juices, and malnutrition, and providing a foundation for disease treatment and nutritional support. These obstructive diseases are often caused by benign stenosis, postoperative adhesions, or post-transplant complications. Patients often experience recurrent abdominal distension, vomiting, and obstructive jaundice, affecting their quality of life, and in severe cases, leading to organ failure. Therefore, stoma surgery is necessary to restore the continuity of the digestive tract and ensure normal nutrient absorption and metabolic function.

[0003] Currently, the commonly used stoma methods in clinical practice mainly include surgical stoma and stent placement stoma. While surgical stoma can create a relatively stable anastomotic channel, it has significant drawbacks: the surgery is highly invasive, requiring open surgery or laparoscopy, and places high demands on the patient's physical condition, especially for elderly patients, those with multiple organ dysfunction, or those with severe abdominal adhesions. The surgical risk is extremely high, the postoperative recovery period is long, and complications such as anastomotic leakage, infection, and abdominal adhesions are easily caused. Some patients lose the opportunity for treatment because they cannot tolerate the surgery. Stent placement stoma, as a minimally invasive method, uses an endoscope to place a metal stent (such as a lumen-to-lumen metal stent) into the obstruction site to quickly establish a channel. However, it has a fatal flaw in cases of benign obstruction: the stent, as a foreign body, remains in the body for a long time, easily stimulating the proliferation of surrounding tissues, leading to stent blockage and displacement. It usually needs to be replaced repeatedly within 6-8 months, forming a cycle of intervention-failure-re-intervention. This not only increases patient suffering and medical burden but may also aggravate tissue damage due to repeated procedures, ultimately failing to form a permanent anastomotic channel and making it difficult to fundamentally solve the obstruction problem. Summary of the Invention

[0004] To address the problems existing in the prior art, this invention provides a gastrointestinal magnetic clamping fistula assembly and its application. By precisely designing the effective working length and width of the clamping end face, it not only ensures the effective size of the fistula channel but also significantly reduces surgical costs and the impact on patients.

[0005] The technical solution adopted in this invention is as follows: In a first aspect, the present invention provides a gastrointestinal magnetic clamping fistula assembly for forming a natural anastomosis channel by clamping the stomach wall and intestinal wall together. The assembly includes at least two magnetic bodies, each magnetic body having a clamping end face that magnetically attracts and adheres to the other magnetic body. The effective length of the outer periphery of the clamping end face is 3-5 cm, and the width is not less than 0.2 cm. When the two magnetic bodies are attracted by the clamping end face, a clamping gap of 2-4 mm is formed between the stomach wall and the intestinal wall.

[0006] It should be noted that the so-called effective peripheral length refers to the outermost length of the contact surface formed when the clamping end face of the magnetic body is clamped and bonded without any intermediate clamping material. This is to avoid situations where the actual length of the clamping end face might be defined as greater than the bonding length defined by this invention due to chamfers or grooves on the end face, thus falling outside the defined range. At the same time, it is only necessary to ensure that the effective length of the outermost contacting and bonding part is within the defined value, that is, the clamping end face is at least an annular surface with an effective length of 3-5cm and a width of not less than 0.2cm.

[0007] In conjunction with the first aspect, the present invention provides a first embodiment of the first aspect, wherein the clamping end face is a plane or a mutually conforming curved surface.

[0008] In conjunction with the first aspect, the present invention provides a second embodiment of the first aspect, wherein the magnetic body has a local natural magnetic structure, and the local natural magnetic structures of two magnetic bodies are paired and positioned to attract each other.

[0009] In conjunction with the first aspect, the present invention provides a third embodiment of the first aspect, wherein the magnetic body has an integral natural magnetic structure, and the magnetic induction intensity generated by the magnetic body at the clamped end face is 1.2-1.6 Tesla.

[0010] In conjunction with the first aspect, the present invention provides a fourth embodiment of the first aspect, wherein the magnetic body includes a first magnet located on the intestinal side when attracted and attached and a second magnet located on the stomach side when adsorbed and attached. The first magnet is a split structure formed by combining several sub-parts. The sub-parts of the first magnet are combined one by one through the intestinal or a fistula-formed channel to form a first magnet with a clamping end face at the corresponding position in the intestinal.

[0011] In conjunction with the first aspect, the present invention provides a fifth embodiment of the first aspect, wherein the magnetic body includes a first magnet located on the intestinal side when attracted and attached and a second magnet located on the stomach side when adsorbed and attached. The first magnet is a structure formed by connecting several sub-parts through a flexible structure. After the volume of the first magnet is changed by the relative displacement between the sub-parts, it passes through the intestinal or a fistula-formed channel and attracts the second magnet at the corresponding position in the intestinal to fix all the sub-parts into a state with a clamped end face.

[0012] It should be noted that the terms "first magnet" and "first magnet" refer to the specific positions of components in the reaction assembly during adsorption. The two magnets can have the same structure or different structures. The magnet located in the intestine needs to pass through a narrow passage; therefore, it is defined as the first magnet to highlight its deformable characteristics for smooth passage through the narrow passage. However, this invention is not limited to the structural features of the magnet entering only the intestine. The second magnet located in the stomach can also adopt a structure with the same characteristics as the first magnet and should also be considered within the scope of this invention. The so-called intestinal or stoma-formed channel refers to the two general pathways through which the first magnet enters the intestine via the stomach. A smooth stoma-formed channel refers to a temporary channel formed by the LAMS scaffold.

[0013] In conjunction with the first aspect, the present invention provides a sixth embodiment of the first aspect, wherein the magnetic body further has a positioning structure that is fixed to the intestinal wall or stomach wall to limit the displacement range of the magnetic body.

[0014] In conjunction with the sixth embodiment of the first aspect, the present invention provides a seventh embodiment of the first aspect, wherein the positioning structure is a fixing clip and the fixing frame is connected to the magnetic body through a flexible structure.

[0015] In conjunction with the first aspect, the present invention provides an eighth embodiment of the first aspect, wherein the magnetic body further has a guiding component that cooperates with a guide wire to guide it into the digestive tract; the guiding component is a through hole disposed on the magnetic body, and the guide wire passes through the through hole.

[0016] Secondly, the present invention provides an application of a gastrointestinal magnetic clamping fistula assembly based on any one of the claims in the formation of a gastrointestinal fistula anastomosis channel.

[0017] The beneficial effects of this invention are as follows: (1) By precisely designing the effective working length and width of the clamping end face, this invention not only ensures the effective size of the stoma channel and avoids the problem of stenosis and failure due to insufficient length or adhesion and closure of the anastomosis caused by a width of less than 0.4cm, but also avoids the disadvantage of food entering the intestine too quickly and affecting gastric digestion due to excessive channel length by limiting the length to 3-5cm, thus ensuring the practicality and stability of the stoma channel. (2) The present invention adopts the magnetic clamping principle. By limiting the magnetic induction intensity of the effective magnetic area and the overall clamping force, it achieves gentle and stable compression of the gastrointestinal wall, promotes orderly ischemic necrosis of the clamped tissue and forms a natural healing anastomosis channel. There is no need to leave permanent foreign bodies. It fundamentally solves the problems of tissue hyperplasia and channel blockage caused by foreign body stimulation in traditional stent fistula. The formed anastomosis channel is permanent and biocompatible, and there is no need for repeated intervention. (3) This invention is compatible with various design forms such as full-end magnetic and local magnetic, and is suitable for different types of magnetic bodies such as permanent magnets and electromagnets. It can also be combined with a bendable or split structure design to reduce the difficulty of endoscopic placement. It is especially suitable for complex anatomical scenarios such as intestinal bends and narrow passages. Compared with surgical fistula creation, it greatly reduces trauma, does not require open abdominal operation, and has higher patient tolerance. It is suitable for elderly patients with multiple underlying diseases and other refractory obstructive patients who cannot tolerate surgery. (4) By limiting the clamping gap to 2-4mm and combining it with the uniform distribution design of the effective magnetic area, the present invention ensures that the pressure on the gastrointestinal wall tissue is uniform, which not only provides suitable conditions for tissue ischemia and necrosis, but also reserves sufficient time for the healing of the anastomotic serosal surface, effectively reducing the risk of complications such as anastomotic leakage and abdominal infection. Compared with the existing technology, it significantly improves the safety and success rate of fistula treatment. Attached Figure Description

[0018] Figure 1 This is an isometric view of a single magnetic body in the fixed scheme of this invention embodiment; Figure 2 This is an isometric view of the bending state of a single magnetic body and the close proximity state of two magnetic bodies in the bending scheme of the embodiment of the present invention. Figure 3 This is an isometric view of the two magnetic bodies in the ring scheme of this invention in a close-up state; Figure 4 This is an isometric view of a single magnetic body in the embedded scheme of this invention embodiment; Figure 5 This is a physical image of a magnetic body according to one embodiment of the present invention; Figure 6 This is a photograph of a magnetic body adsorbing and bonding according to one embodiment of the present invention. Figure 7 This is an X-ray image of a magnetic body in an unadsorbed state during surgery, according to one embodiment of the present invention. Figure 8 This is an X-ray image of the magnetic body in its adsorption state during surgery, according to one embodiment of the present invention. Figure 9 This is a schematic diagram illustrating the failure of the pre-implanted gastrointestinal anastomotic stent in an embodiment of the present invention; Figure 10 This is a schematic diagram of the postoperative fixation of the gastric side magnetic body in an embodiment of the present invention; Figure 11 This is a schematic diagram of the postoperative intestinal side magnetic fixation in an embodiment of the present invention; Figure 12 This is a first X-ray image of the magnetic body in a tightly adhered state 24 hours after surgery, according to an embodiment of the present invention. Figure 13This is a second X-ray image of the magnetic body in a tightly adhered state 24 hours after surgery, according to an embodiment of the present invention. Figure 14 This is the first endoscopic view of the gastrointestinal anastomotic fistula formed 6 days postoperatively in an embodiment of the present invention; Figure 15 This is a second view of the endoscopic image of the gastrointestinal anastomotic fistula formed 6 days post-operation in an embodiment of the present invention; Figure 16 This is an image of the magnet removed post-surgery in an embodiment of the present invention; Figure 17 This is a schematic diagram of the gastrointestinal anastomosis fistula after the magnetic body is removed postoperatively in an embodiment of the present invention; Figure 18 This is a schematic diagram of the first fistula formed during a follow-up examination three weeks after surgery in an embodiment of the present invention; Figure 19 This is a schematic diagram of the second fistula formed during a follow-up examination three weeks after surgery in an embodiment of the present invention; Figure 20 This is a schematic diagram of a barium meal examination three weeks after surgery, as described in this embodiment of the invention.

[0019] In the figure: 1-Magnetic body, 101-Clamping end face, 102-Sub-part, 2-Fixing hole, 3-Guide hole, 4-Embedded magnet. Detailed Implementation

[0020] The present invention will be further explained below with reference to the accompanying drawings and specific embodiments.

[0021] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0022] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0023] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0024] In the description of this application, it should be noted that the use of terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" to indicate orientation or positional relationships is based on the orientation or positional relationships shown in the accompanying drawings, or the orientation or positional relationships commonly used when the product is in use. These terms are used solely for the convenience of describing this application and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the use of terms such as "first" and "second" in the description of this application is only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0025] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of this application does not imply that the component is required to be absolutely horizontal or suspended, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0026] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0027] Example 1: This embodiment discloses a gastrointestinal magnetic clipping stoma assembly, mainly targeting the stoma needs of patients with gastric outflow tract obstruction (such as recurrent obstruction caused by benign stenosis of the duodenal bulb) in clinical practice. It provides a minimally invasive, incision-free surgical assembly that does not require open surgery or laparoscopic operation and can be inserted and fixed under endoscopic guidance.

[0028] The gastrointestinal magnetic clipping fistula assembly of this embodiment includes two structurally adapted magnetic bodies 1. Both magnetic bodies 1 are made of biocompatible materials and permanent magnet materials, and are non-toxic and non-allergenic, meeting the standards for implantable medical devices.

[0029] Each magnetic body 1 has a clamping end face 101 for magnetic attraction and contact with another magnetic body 1, and the external dimensions of the clamping end face 101 are as follows: Its effective working length is 3-5cm and its width is not less than 0.2cm; the thickness direction of the magnetic body 1 is not specifically limited, as long as the clamping end face 101 can be stably attached.

[0030] It should be noted that the so-called external dimension refers to the external dimension of the largest contact surface when the clamping end faces 101 of the two magnetic bodies 1 are attached. There should be no contact part outside the range of this external dimension, and the part within this range is not limited to whether there is a contact surface.

[0031] After the two magnetic bodies 1 are fixed to the stomach side and the intestinal side respectively, they approach and adhere to each other through magnetic attraction. The stomach wall and the intestinal wall are clamped between the two clamping end faces 101. The clamping gap formed, i.e. the clamping thickness after the stomach wall and the intestinal wall are superimposed, is 2-4 mm. This thickness can ensure orderly ischemic necrosis of the clamped tissue, while reserving sufficient time for the healing of the serosal surface of the anastomosis.

[0032] The method of using the clamping fistula assembly in this embodiment is as follows: First, a magnetic object 1 is inserted into the intestine through the stomach, either through a pre-fabricated metal stent channel or by traction and dilation through the obstruction site into the posterior intestinal space. A positioning structure then fixes the first magnet to a suitable intestinal wall, limiting its movement and preventing it from falling into the posterior intestinal tract during subsequent procedures. Next, another magnetic object 1, the second magnet, is introduced into the stomach and moved until the distance between it and the first magnet is less than a threshold. When the spatial distance between the two magnetic objects 1 is less than the threshold, the two magnetically compatible clamping end faces 101 automatically adjust their spatial angle under the influence of the magnetic field, clamping the intestinal and stomach walls end-to-end. After 5-7 days, all tissue within the clamped area necroses and dissipates, while the intestinal and stomach walls outside the clamping end faces 101 spontaneously anastomose to form a connecting wall. The magnetic object 1 fixed in the intestine and the magnetic object 1 in the stomach remain in an attracted state and remain in a limited position until the magnetic object 1 is removed endoscopically to complete the stoma.

[0033] Example 2: This embodiment is based on the technical solution of embodiment 1. Animal experiments were conducted to verify the influence of different sizes and magnetic parameters on the fistula formation effect, and to clarify the optimal parameter range of the components. The experimental subjects were 15 healthy adult pigs (weighing 25-30kg), which were randomly divided into 7 groups of 2-3 pigs each. Fistula formation experiments were conducted using components with different parameters. The effect was evaluated regularly after the operation by endoscopy, X-ray fluoroscopy and anatomical examination.

[0034] 1. Experimental parameter design This embodiment designs multiple specification schemes. The core parameters include the effective length and width of the clamping end face and the magnetic induction intensity at the clamping end face. The specific groupings are shown in the table below: Table 1 Grouping of fistula test Grouping Effective length of clamped end face (cm) Width of clamped end face (cm) Magnetic flux density (T) Expected gap to be closed (mm) Best Group 3.5-4.5 0.4-0.8 1.3-1.5 2.5-3.5 Length lower limit group 3 0.5 1.4 3 Length upper limit group 5 0.5 1.4 3 Length exceeding the lower limit group 2 0.5 1.4 3 Groups exceeding the length limit 6 0.5 1.4 3 Width lower limit group 4 0.1 1.4 3 Excessive magnetic force 4 0.5 1.7 1.5 Magnetic force group 4 0.5 1.1 5 2. Experimental process All experimental pigs were fasted for 12 hours and deprived of water for 6 hours before surgery. Two sets of magnetic objects were placed into the stomach and proximal jejunum under endoscopic guidance. Guide wires and sutures were used for guidance and fixation to ensure accurate positioning and stable adsorption of the magnetic objects. Prophylactic antibiotics, proton pump inhibitors and total parenteral nutrition were given after surgery. Follow-up evaluations were conducted on 3, 7, 14 and 21 days after surgery.

[0035] 3. Experimental Results and Analysis The effect of the effective length of the clamped end face on the fistula effect: The optimal group (3.5-4.5cm): Endoscopic examination 7 days after surgery showed that the anastomosis began to be epithelialized, and a smooth and stable natural anastomosis channel was formed at 21 days, without stenosis, adhesion or food accumulation. The pigs' feeding and digestive functions were normal. Upper limit of length group (5.0cm): 14 days after surgery, the pigs emptied their food too quickly and their weight gain was slow. The autopsy revealed that the anastomosis channel was too long. Food did not mix well with gastric acid in the stomach before entering the intestines, resulting in incomplete nutrient absorption. Some pigs showed symptoms of diarrhea. The group with a length exceeding the upper limit (6.0cm): The above-mentioned symptoms of indigestion were more pronounced, and due to the excessive length of the channel, the tension at both ends of the anastomosis was greater. One pig developed mild leakage at the anastomosis 10 days after surgery, which required symptomatic treatment to heal. The lower limit of length group (3.0cm): The anastomosis was patent at the 21-day follow-up examination, but the channel diameter was relatively narrow (about 0.5cm), posing a small risk of food residue. Group with length exceeding the lower limit (2.0cm): Anastomotic adhesion and closure occurred 14 days after surgery, the endoscope could not pass through, and the fistula failed. The anatomy showed that due to insufficient effective length, the clamping channel was too narrow, and adhesion was prone to occur during the tissue healing process.

[0036] It should be noted that the upper and lower limit groups of length are grouped according to the final effect of different sample lengths. The groups are determined based on the results. Before the experiment, only a general length range value is determined. The following parameters are tested in a similar manner.

[0037] The effect of clamping end face width on fistula effect: The optimal group (0.4-0.8cm): the anastomosis heals uniformly, with no risk of adhesion or closure, and the fistula diameter stabilizes at 1.0-1.2cm after 21 days; The lower limit of width (0.1cm): Local adhesion of the anastomosis occurred 7 days after the operation and was completely closed after 14 days. The fistula failed because the width was too small, resulting in insufficient circumference of the channel formed by clamping. During the tissue healing process, adhesion was easily caused by inflammatory reaction, and the channel could not be kept open.

[0038] The effect of magnetic induction intensity (magnetic force) on fistula formation: The optimal group (1.3-1.5T): the clamped gap is stable at 2.5-3.5mm, the tissue begins to be ischemic and necrotic 3 days after surgery, the necrotic tissue sloughs off at 7 days, the serosal surface of the anastomosis heals at 14 days, and a complete epithelialized fistula is formed at 21 days, with no complications such as leakage or infection. The group with excessive magnetic force (1.7T) had a clamping gap of only 1.5mm. Three days after the operation, the clamped tissue rapidly became ischemic and necrotic, but the serosal surface of the anastomosis did not fully heal. Two pigs developed anastomotic leakage five days after the operation. The autopsy showed that the intestinal wall and stomach wall were not fully adhered, and the necrotic tissue sloughed off too quickly, resulting in communication between the abdominal cavity and the intestinal wall. Magnetic force over-group (1.1T): The gap was clamped to 5.0mm, the magnetic adsorption force was insufficient, the magnetic body shifted 3 days after the operation, the clamping was not firm, the tissue ischemia and necrosis progressed slowly, and no effective anastomosis was formed after 21 days, resulting in fistula failure.

[0039] 4. Experimental Conclusions Verified through pig experiments, the optimal parameter range of the gastrointestinal magnetic clamping fistula component of the present invention is as follows: effective length of clamping end face 3.5-4.5cm, width 0.4-0.8cm, magnetic induction intensity at clamping end face 1.3-1.5T, and corresponding clamping gap 2.5-3.5mm.

[0040] A length exceeding 5cm can easily lead to incomplete digestion and absorption of food, while a length less than 3cm can easily cause anastomotic stenosis or adhesion closure. A width of less than 0.2cm cannot maintain the passageway and is prone to adhesion and blockage; A magnetic induction intensity exceeding 1.6T (excessive magnetic force) can lead to rapid tissue necrosis and increase the risk of anastomotic leakage; a value below 1.2T (insufficient magnetic force) will result in weak adhesion, failure to form an effective clamp, and fistula failure.

[0041] Example 3: This embodiment discloses a structurally fixed gastrointestinal magnetic clipping fistula assembly, with corresponding attachments. Figure 1 Axonometric drawing of a single magnetic body in a fixed configuration Figure 5 Actual picture of the magnetic object and Figure 6 The image shows the actual product when the magnetic body is attached. The core is a long strip-shaped integrated structure, which is suitable for precise placement and stable fixation under clinical endoscopic guidance. It is especially suitable for minimally invasive fistula treatment in scenarios such as gastric outflow obstruction and biliary-enteric anastomosis stenosis.

[0042] The gastrointestinal magnetic clipping fistula assembly of this embodiment includes two magnetic bodies 1 with identical structures. The core structure and material design are as follows: The magnetic body 1 is a long strip-shaped integrated structure with all edges rounded with a radius of 0.2cm to avoid scratching the digestive tract mucosa during insertion. The two end faces of the long side of each magnetic body 1 are a clamping end face 101. The clamping end face 101 is a flat plane without any concave or convex structures to ensure a tight fit and uniform force when it is attracted to another magnetic body 1.

[0043] Each magnetic body 1 has two fixing holes 2, which are evenly distributed along the length of the magnetic body 1 and symmetrically arranged on both sides of the clamping end face 101. The fixing holes 2 are through holes that penetrate along the thickness direction of the magnetic body 1, with a diameter of 0.4 cm. They are used to pass through medical non-absorbable sutures or connect fixing clips to realize the detachable fixing of the magnetic body 1 to the stomach / intestinal wall and limit the displacement range of the magnetic body 1.

[0044] The guide hole 3 is a through hole that runs through the entire magnetic body 1 along its length. The hole diameter is 0.3 cm. It is used to insert a guide wire and, in conjunction with the endoscope, to achieve precise guidance of the magnetic body 1 in the digestive tract, reducing the difficulty of the insertion operation.

[0045] The magnetic body 1 is made of biocompatible neodymium iron boron permanent magnet material. This material is non-toxic and non-allergenic, meets the standards for implantable medical devices, and has stable magnetic properties. It can maintain the set magnetic induction intensity for a long time, avoiding the impact of magnetic field attenuation on the fistula formation effect.

[0046] Furthermore, the effective length of the clamping end face 101 is 4cm, the width is 0.6cm, and the thickness is 0.5cm. These parameters are within the optimal parameter range verified in Example 2, which can ensure the effective size of the stoma channel and avoid problems such as indigestion and adhesion closure.

[0047] The magnetic induction intensity generated by the magnetic body 1 at the clamping end face 101 is 1.4 Tesla, corresponding to 14000 Gauss. This magnetic field intensity can form a 3mm clamping gap when the two magnetic bodies 1 are adsorbed, which not only meets the needs of tissue ischemia and necrosis, but also allows sufficient time for the anastomosis serous surface to heal.

[0048] The component installation and usage process in this embodiment: Preoperative preparation: Identify the obstruction site through endoscopy and X-ray fluoroscopy, determine the placement position of magnetic body 1, and prepare auxiliary instruments such as guide wire, medical sutures, endoscope clips, and non-magnetic pushers.

[0049] Insertion of magnetic body 1: Pass the guide wire through the guide hole 3, and with the help of the endoscope and a non-magnetic pusher, push the two magnetic bodies 1 to the corresponding positions in the stomach and intestine respectively, ensuring that the clamping end face 101 faces each other.

[0050] Fixation and positioning: Sutures are passed through the fixation hole 2, and the gastric magnetic body 1 is fixed to the stomach wall and the intestinal magnetic body 1 is fixed to the intestinal wall using the endoscope clip. X-ray fluoroscopy confirms that the distance between the two magnetic bodies 1 is ≤8mm and that the clamped end faces 101 are opposite.

[0051] Adsorption and bonding: The two magnetic bodies 1 automatically approach and bond with each other through magnetic attraction. The stomach wall and intestinal wall are clamped between the two clamping end faces 101, forming a 3mm clamping gap, and the tissue ischemia, necrosis and healing process begins.

[0052] Postoperative removal: Six days after the operation, endoscopic examination confirmed epithelialization of the anastomosis, the fixation sutures were cut, and the two magnetic bodies were removed one by one using endoscopic forceps, thus completing the fistula treatment.

[0053] The magnetic body 1 in this embodiment has a simple structure and is easy to operate. The optimal parameter design verified in Embodiment 2 can form a stable clamping effect between the stomach and intestinal walls. In clinical application, no open surgery or laparoscopic operation is required; treatment can be completed solely under endoscopic guidance, significantly reducing surgical trauma and improving patient tolerance. It is particularly suitable for elderly patients or those with multiple underlying diseases who cannot tolerate surgery for refractory obstruction. Postoperative X-ray fluoroscopy 24 hours after surgery showed that the magnetic body 1 was tightly adhered. After removing the magnetic body 1 6 days later, the anastomosis was patent and seamless, with no contrast agent leakage. A follow-up examination three weeks postoperatively showed a stable natural anastomotic channel with no complications such as stenosis, adhesion, or leakage, resulting in a high success rate of stoma creation.

[0054] It should be noted that this fixed magnetic body 1 structure is made of permanent magnet material, which has the lowest cost and is easy to use. However, in other embodiments, other magnets with the same magnetic field strength can be used, and a layer of polymer material that meets medical standards can be formed on its surface. The magnetic field strength of the magnet inside can be optimized according to the thickness of the polymer material covering the surface.

[0055] Example 4: This embodiment discloses a flexible gastrointestinal magnetic clipping fistula assembly, with corresponding accessories. Figure 2 The axonometric images show the bending state of a single magnetic body and the close proximity state of two magnetic bodies. The core solution is to address the difficulty of maneuvering a fixed, long, strip-shaped magnetic body through the LAMS stent channel. It is especially suitable for stent placement scenarios where the LAMS stent has already been placed, the channel is narrow, or there are many bends in the intestine, enabling more convenient endoscopic placement.

[0056] The gastrointestinal magnetic clipping fistula assembly of this embodiment includes two matching magnetic bodies 1, wherein the first magnet on the intestinal side is a flexible, split structure, and the second magnet on the gastric side can adopt the fixed elongated structure of Embodiment 3. The core design is as follows: The first magnet structure consists of several identical triangular prism-shaped sub-parts 102, each with a triangular cross-section. All sub-parts 102 are arranged sequentially along their length and connected by a parallel biocompatible polymer strip. The polymer strip is made of polytetrafluoroethylene (PTFE), with a thickness of 0.1 cm and a width of 0.3 cm. It possesses good toughness and antimagnetic properties, and can withstand the magnetic attraction between the magnets 1 without breaking or deforming.

[0057] Sub-part 102 is made of biocompatible neodymium iron boron permanent magnet material, which is non-toxic and non-allergenic. After several sub-parts 102 are combined, the resulting clamping end face 101 has an effective length of 4 cm and a width of 0.6 cm, perfectly matching the dimensions of the clamping end face 101 of the second magnet. (Refer to...) Figure 2 As shown. The magnetic induction intensity generated by each sub-part 102 in the corresponding clamping end face 101 region is 1.4 Tesla, corresponding to 14000 Gauss. The three sub-parts 102 work together to form a 3mm clamping gap when the first magnet and the second magnet are attracted.

[0058] The polymer strips can drive the relative displacement of sub-parts 102, enabling the first magnet to bend in multiple ways, including: Arc-shaped bending method: Several sub-parts 102 are bent in the same direction to form an arc-shaped structure, which adapts to the natural curves of the intestine; In other embodiments, a folding method is included, in which the middle polymer strip is used as the bending part and the two end portions 102 are folded inward. After folding, the total length of the first magnet is shortened to 2.2cm, which facilitates passage through narrow channels. Furthermore, each sub-part 102 of the multi-segment bending structure can be bent independently to form an irregular polygonal structure, adapting to the complex path within the LAMS support channel.

[0059] Component installation and usage process: Preoperative preparation: Confirm the diameter and orientation of the LAMS stent channel, prepare auxiliary instruments such as non-magnetic pusher, medical sutures, and endoscopic clips, and bend the sub-part 102 of the first magnet along the polymer strip into a shape that matches the channel (such as a folded or arc shape).

[0060] First magnet placement: The bent first magnet is inserted into the non-magnetic pusher and slowly pushed along the LAMS stent channel under endoscopic guidance. During the push, the bending angle is adjusted according to the channel direction to avoid jamming, until the first magnet is delivered to the target position in the intestine.

[0061] Second magnet placement and adsorption: Following the method of Example 3, the second magnet is pushed to the corresponding position in the stomach cavity through an endoscope. X-ray fluoroscopy confirms that the distance between the two magnets 1 is ≤8mm. The sub-part 102 of the first magnet automatically unfolds under the magnetic attraction of the second magnet, aligns to form a complete clamping end face 101, and precisely fits with the clamping end face 101 of the second magnet. The stomach wall and the intestinal wall are clamped between the two to form a 3mm clamping gap.

[0062] Fixation and healing: Sutures are passed through the fixation hole 2 on sub-part 102, and the first magnet is fixed to the intestinal wall using endoscopic clips, and the second magnet is fixed to the stomach wall. X-ray fluoroscopy 24 hours after the operation confirms that the magnetic body 1 is tightly attached, and endoscopic examination 6 days later confirms that the anastomosis is epithelialized. After the sutures are cut, the second magnet and the first magnet are removed in sequence.

[0063] The bendable structure of this embodiment specifically solves the operational challenges of using a fixed 4cm long magnetic body through the LAMS stent channel: after bending, the volume and length of the first magnet are significantly reduced, resulting in a significant decrease in resistance when passing through narrow channels or intestinal bends, shortening the endoscopic operation time compared to the fixed magnetic body, and improving the channel throughput. The antimagnetic design of the polymer strip prevents the sub-part 102 from self-adheding during bending or pushing, ensuring smooth operation; after adsorption, the sub-part 102 can be fully unfolded to form a clamping end face 101 consistent with the fixed magnetic body, ensuring the effective size and clamping effect of the stent channel.

[0064] Example 5: This embodiment discloses a ring-shaped gastrointestinal magnetic clipping fistula assembly, with corresponding attachments. Figure 3 Axonometric drawing of the two magnetic bodies in close proximity in the ring scheme and Figure 4 The embedded solution's single magnetic body isometric view differs from the traditional planar clamping end face design. It achieves the construction of tissue ischemia and necrosis and anastomosis channels through the annular clamping area, without relying on a completely fitted planar clamping, making it suitable for stoma scenarios with low requirements for the flatness of the clamping surface.

[0065] The first structural form Reference Figure 3 The component includes two size-matched annular magnetic bodies 1. The core functional surface of each annular magnetic body 1 is an annular clamping end face 101. The annular clamping end face 101 is arranged along the axial direction of the magnetic body 1. Its effective length (annular axial height) is 3.5cm, its width (annular end face radial thickness) is 0.5cm, its annular inner diameter is 1.5cm, and its outer diameter is 2.5cm, which meets the limiting requirements of an effective length of 3-5cm and a width of not less than 0.2cm for the clamping end face.

[0066] The ring-shaped magnetic body 1 is made entirely of biocompatible neodymium iron boron permanent magnet material, which is non-toxic, non-allergenic, and has stable magnetic properties. The edges of the ring-shaped clamping end face 101 are rounded with a radius of 0.15cm to avoid scratching the digestive tract mucosa during insertion. The magnetic induction intensity generated by the magnetic body 1 at the ring-shaped clamping end face 101 is 1.4 Tesla, corresponding to 14000 Gauss, ensuring that a 3mm clamping gap is formed when the two ring-shaped magnetic bodies 1 are adsorbed.

[0067] Using a non-magnetic pusher and endoscopic guidance, two annular magnetic bodies 1 are pushed to corresponding positions in the stomach and intestines, respectively, so that the annular clamping end faces 101 are aligned. A guide wire is inserted through the annular central guide channel to adjust the position of the magnetic bodies 1, ensuring that the distance between the two annular magnetic bodies 1 is ≤8mm. Sutures are set directly using the structure of the annular magnetic bodies 1, and the two magnetic bodies 1 are fixed to the stomach wall and intestinal wall respectively by endoscopic clamps. The two annular magnetic bodies 1 are precisely attracted by magnetic attraction, and the annular clamping end faces 101 fit together to form an annular clamping area, in which the corresponding parts of the stomach wall and intestinal wall are clamped within the annular area.

[0068] Because this annular clamping area applies uniform annular pressure to the clamped gastrointestinal wall tissue, it blocks the external blood supply to the local tissue. The tissue on the inner side that is not directly clamped gradually becomes ischemic and necrotic due to the interruption of blood supply, and eventually detaches from the original tissue and is naturally discharged along the intestine. The annular clamping area maintains a clamping gap of 2-4 mm, providing a stable environment for the healing of the serosal surface of the surrounding tissue. Finally, a smooth anastomosis channel is formed around the annular area, and the fistula function can be achieved without relying on full-plane apposition.

[0069] The second structural form Reference Figure 4 The component comprises two annular bodies, which are non-magnetic and have the same external dimensions as the first structural form (effective axial length 3.5cm, width 0.5cm, inner diameter 1.5cm, outer diameter 2.5cm). A groove, 0.3cm deep and 0.4cm wide, is provided circumferentially on the inner wall of each annular body for embedding a magnet 4. The magnetic poles of the embedded magnets 4 are aligned to ensure a clear directionality when the two annular bodies are attracted.

[0070] The ring-shaped body is made of biocompatible polyetheretherketone (PEEK), which has high mechanical strength, is resistant to biological corrosion, and is non-magnetic, so it will not interfere with the magnetic field of the embedded magnet 4. The embedded magnet 4 is made of biocompatible neodymium iron boron permanent magnet material, and the magnetic induction intensity of the embedded magnet 4 is 1.3 Tesla, corresponding to 13,000 Gauss. The ring magnetic field formed by splicing the three pieces can create a 2.8mm gap when the two ring bodies are adsorbed. The surface of the embedded magnet 4 is covered with a 0.1cm thick biocompatible silicone layer to prevent the magnet from directly contacting the ring body or human tissue.

[0071] The embedded magnet 4 provides a stable and directional adsorption force, ensuring precise alignment of the two annular bodies. The annular clamping area applies uniform pressure to the gastrointestinal wall tissue, blocking local blood supply. The annular body itself is not magnetic, and the adsorption force is transmitted only through the embedded magnet 4, avoiding direct contact between magnetic materials and human tissue, further improving biosafety. The inner tissue dies due to ischemia caused by the interruption of blood supply and is naturally discharged. The tissue around the annular clamping area gradually heals, eventually forming a stable anastomotic channel to achieve the fistula function.

[0072] Example 6: This embodiment discloses a gastrointestinal magnetic clamping stoma assembly with a concave-convex snap-fit ​​positioning structure. The core feature is that the clamping end face adopts a concave-convex fitting design, and the magnetic body is only set at the concave-convex docking part. The local high magnetic field strength achieves precise adsorption and layered necrosis effect, which is suitable for stoma scenarios with high positioning accuracy requirements.

[0073] The component includes two matching magnetic bodies 1. Each magnetic body 1 has several evenly distributed concave-convex snap-fit ​​structures on its clamping end face 101, with the protrusions and grooves corresponding one-to-one. The main body of the magnetic body 1 is a non-magnetic structure, with magnetic blocks embedded only in the top surface of the protrusions and the bottom surface of the grooves. The magnetic blocks are evenly distributed along the length of the clamping end face 101. The effective length of the clamping end face 101 is 4 cm and the width is 0.6 cm, which meets the core parameter requirements. The magnetic body 1 has two fixing holes 2 and one guide hole 3, which are located in the same positions as in embodiment 3, for fixing and guiding.

[0074] The main body of the magnetic body 1 is made of biocompatible polyetheretherketone material, which has high mechanical strength and is non-magnetic; the embedded magnetic block is made of high-performance biocompatible neodymium iron boron permanent magnet material; the magnetic induction intensity generated by the magnetic block at the docking surface is not less than 2 Tesla, corresponding to 20,000 Gauss, which is higher than the magnetic field strength of the overall magnetic structure, ensuring precise adsorption of the concave and convex structure.

[0075] Two magnetic bodies 1 are placed into the target positions in the stomach cavity and intestine, respectively, so that the concave and convex structures of the clamping end face 101 are aligned with each other; the high magnetic field strength generated by the magnetic block drives the concave and convex structures to automatically snap and position, avoiding adsorption misalignment; the magnetic bodies 1 are fixed by threading through the fixing hole 2 to ensure that the clamping gap at the outer edge is stable at 3mm.

[0076] Due to the high magnetic field strength of the magnetic block, the internal tissue clamped at the concave-convex clamping site is subjected to tighter force, which can lead to rapid ischemia and necrosis. However, the clamped tissue at the outermost edge of the magnetic body 1, which is not in direct contact with the magnetic block, is only affected by the overall adsorption force. The necrosis process is consistent with that of the fixed clamping, and the tissue is necrotic and detached in 6-7 days. During this period, the external stoma channel wall simultaneously completes the healing of the serosal surface and epithelialization, ultimately forming a smooth and stable anastomotic channel.

[0077] Example 7: This embodiment provides an example of performing a colostomy on a patient with benign intestinal obstruction using the fixed magnetic body 1 in Embodiment 3 above. The process is as follows: Figures 7-20 As shown.

[0078] The patient has already undergone two LAMS stent surgeries, but LAMS stents have an expiration date. (Refer to...) Figure 9 The image shows the patient's initial condition before the application of this invention. It is evident that the previously implanted LAMS stent had become blocked or experienced tissue hyperplasia, causing the established channel to fail and resulting in recurrent obstruction symptoms. Rescue treatment using a magnetic clip-on stent assembly was required.

[0079] in, Figure 7 This shows the position of the two magnetic objects after insertion, before they attract each other. The gastric magnetic object is located in the stomach cavity, and the intestinal magnetic object is located in the jejunum cavity. The two are not yet aligned and attached, separated by the stomach wall and intestinal wall tissue. X-ray imaging can be used to observe that the two magnetic objects are separated. At this time, the guidewire may still be passing through guide hole 3 for positioning.

[0080] Figure 8 The image shows that after release, the two magnetic objects 1, attracted by magnetism, have penetrated the stomach and intestinal walls to achieve a tight fit. X-rays show that the contrast markers of the two magnetic objects 1 completely overlap or are precisely aligned, indicating that the clamping ends have effectively compressed the stomach and intestinal walls, forming the predetermined 2-4 mm clamping gap, thus completing the surgical procedure.

[0081] Figure 10 and Figure 11 This shows the endoscopic images of the fixation of the gastric and intestinal magnetic bodies after surgery. Endoscopic observation of the stomach cavity shows that the gastric magnetic body is firmly attached to the inner side of the stomach wall, well-fixed, and without displacement or detachment. Observation through a colonoscope or gastroscope into the jejunum shows that the jejunal magnetic body is firmly attached to the inner side of the intestinal wall, with its position precisely corresponding to the gastric magnetic body.

[0082] Figure 12 and Figure 13 These are two views from an X-ray examination 24 hours post-surgery. The abdominal X-ray shows that the two magnetic objects have achieved tight adhesion and are in a stable position without displacement 24 hours after surgery. The imaging marks of the magnetic objects are clear and the alignment is precise, confirming that the components have good early stability in vivo and the clamping gap is maintained within the designed range.

[0083] Figure 14 and Figure 15 These are two endoscopic views of the gastrointestinal anastomotic fistula formation 6 days post-surgery. Endoscopic observation shows that after 6 days of continuous magnetic compression, the clamped gastric and intestinal wall tissues underwent orderly ischemic necrosis and sloughed off, initially forming a fistula with a diameter of approximately 2-3 mm. The wound is clean, with neat edges, and the serosal layer is visible to have begun to align and heal, with no active bleeding.

[0084] Figure 16 This is an image of the removed magnets, showing the magnetic components removed endoscopically approximately 2-4 weeks post-surgery. The image shows a small amount of necrotic tissue, fibrin, and a thread passing through fixation hole 2 on the surfaces of the two magnets, but the overall structure is intact, without corrosion or damage. No permanent foreign bodies remain in the body after removal.

[0085] Figure 17 This is an endoscopic image of the gastrointestinal anastomotic fistula after the removal of the two clamped magnetic objects. Endoscopic observation shows a permanent gastrointestinal anastomotic fistula formed after the removal of the magnetic objects. The fistula is approximately 3-4 mm in diameter, with smooth edges, covered by mature fibrous tissue and epithelial cells, and is in a stable healing state. There is no stenosis, bleeding, or inflammatory reaction in the surrounding tissues.

[0086] Figure 18 and Figure 19 A follow-up endoscopic examination three weeks post-surgery showed that the fistula had formed a complete biological channel. The endoscope could freely enter and exit the gastric and intestinal cavities through the fistula opening. The fistula walls were smooth and elastic, and the diameter was stable, confirming the successful establishment of a permanent anastomotic channel.

[0087] Figure 20 The barium meal imaging was performed three weeks post-surgery. The upper gastrointestinal barium meal examination showed that the contrast agent passed smoothly through the stomach into the intestines, with no obstruction, leakage, or stenosis at the fistula site. The image clearly showed the location, size, and shape of the fistula, confirming that the established gastrointestinal anastomosis channel had completely restored the continuity of the digestive tract and functioned normally.

[0088] Figure 7-20 The entire process of magnetic clip-on fistula technology, from surgical operation, early alignment, tissue necrosis, fistula formation to final functional verification, is fully demonstrated, providing clinical evidence to support the effectiveness, safety and permanent efficacy of the technology.

[0089] This invention is not limited to the optional embodiments described above, and anyone can derive other various forms of products based on the inspiration of this invention. The specific embodiments described above should not be construed as limiting the scope of protection of this invention; the scope of protection of this invention should be determined by the claims, and the specification can be used to interpret the claims.

Claims

1. A gastrointestinal magnetic clamping fistula assembly, used to form a natural anastomosis channel by clamping and adhering to the stomach and intestinal walls, characterized in that: It includes at least two magnetic bodies (1), each magnetic body (1) having a clamping end face (101) that magnetically attracts and adheres to another magnetic body (1). The effective length of the outer periphery of the clamping end face (101) is 3-5 cm and the width is not less than 0.2 cm. When the two magnetic bodies (1) are attracted by the clamping end face (101), a clamping gap of 2-4 mm is formed between the stomach wall and the intestinal wall.

2. The gastrointestinal magnetic clipping fistula assembly according to claim 1, characterized in that: The clamping end face (101) is a plane or a mutually conforming curved surface.

3. The gastrointestinal magnetic clipping fistula assembly according to claim 1, characterized in that: The magnetic body (1) has a local natural magnetic structure, and the local natural magnetic structures of the two magnetic bodies (1) are paired and positioned to attract each other.

4. The gastrointestinal magnetic clipping fistula assembly according to claim 1, characterized in that: The magnetic body (1) has an integral natural magnetic structure, and the magnetic induction intensity generated by the magnetic body (1) at the clamped end face (101) is 1.2-1.6 Tesla.

5. A gastrointestinal magnetic clipping fistula assembly according to claim 1, characterized in that: The magnetic body (1) includes a first magnet located on the intestinal side when attracted and attached and a second magnet located on the stomach side when adsorbed and attached. The first magnet is a split structure formed by combining several sub-parts (102). The sub-parts (102) of the first magnet are combined in the corresponding positions of the intestine after passing through the intestinal or stoma channels to form a first magnet with a clamping end face (101).

6. The gastrointestinal magnetic clipping fistula assembly according to claim 1, characterized in that: The magnetic body (1) includes a first magnet located on the intestinal side when attracted and attached, and a second magnet located on the stomach side when adsorbed. The first magnet is a structure formed by connecting several sub-parts (102) through a flexible structure. The volume of the first magnet is changed by the relative displacement between the sub-parts (102). After passing through the intestinal or fistula-formed channel, the first magnet attracts the second magnet at the corresponding position in the intestinal and fixes all the sub-parts (102) to form a state with a clamping end face (101).

7. A gastrointestinal magnetic clipping fistula assembly according to claim 1, characterized in that: The magnetic body (1) also has a positioning structure that is fixed to the intestinal wall or stomach wall to limit the displacement range of the magnetic body (1).

8. A gastrointestinal magnetic clipping fistula assembly according to claim 7, characterized in that: The positioning structure is a fixing clip, and the fixing frame is connected to the magnetic body (1) through a flexible structure.

9. A gastrointestinal magnetic clipping fistula assembly according to claim 1, characterized in that: The magnetic body (1) also has a guide assembly that works with the guide wire to guide it into the digestive tract; the guide assembly is a guide hole (4) provided on the magnetic body (1), through which the guide wire passes.

10. The application of the gastrointestinal magnetic clamping fistula assembly according to any one of claims 1-9 in the formation of a gastrointestinal fistula anastomosis channel.

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