An anal elliptical ring-shaped magnetic squeezing dredging assembly for treating rectal stenosis and a method of using the same

Abstract

This invention relates to a transanal elliptical magnetic compression and unblocking component for treating rectal stenosis and its method of use, belonging to the field of medical devices. It includes an elliptical shell A, an elliptical shell B, a magnet component A, and a magnet component B. Magnet component A is embedded within elliptical shell A, and magnet component B is embedded within elliptical shell B. Under the action of magnet components A and B, elliptical shell A and elliptical shell B are attracted together, and their shapes are adapted to each other. This invention provides a transanal magnetic compression and unblocking device adaptable to different degrees and types of rectal stenosis. Through structural optimization, it improves the passageability and compression accuracy of the stenotic segment, solving the problem of rectal stenosis for patients and improving their quality of life.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a transanal elliptical magnetic compression and unblocking component for treating rectal stenosis and its method of use. Background Technology

[0002] Rectal stenosis is a common complication after radiotherapy for rectal tumors, rectal tumor resection, and vertical rectal mucosal resection for hemorrhoids and rectal prolapse. It can cause abdominal distension, abdominal pain, and difficulty in defecation, severely impacting the patient's quality of life. Due to the high incidence of the aforementioned diseases, this complication is also quite common in clinical practice. Currently, the main methods for treating rectal stenosis are dilation with dilators, stent placement, and surgical treatment, as detailed below: (1) Mechanical dilation therapy: For rectal stenosis located in a low position, mechanical dilation can be performed first. Among them, anal dilation with an anal dilator is the most commonly used mechanical dilation method in the early stage of stenosis. This device is available on online platforms such as JD.com and Taobao.

[0003] (2) Endoscopic treatment: Endoscopic treatment mainly includes endoscopic balloon dilation, endoscopic stent placement, and endoscopic anastomotic incision. Endoscopic balloon dilation uses a 26mm diameter balloon to dilate the stenotic anastomosis for 5 minutes under endoscopy to dilate the stenotic ring; endoscopic stent placement uses a self-expanding metal stent to place the stenotic segment under endoscopy to open the stenosis; endoscopic anastomotic incision is performed by making radial incisions or circular excision of the stenotic scar tissue around the anastomosis to relieve the stenosis.

[0004] (3) Surgical treatment: including internal rectal incision, posterior rectal incision, seton technique, and rectal resection with colostomy. Internal rectal incision refers to making a longitudinal incision along the posterior midline of the rectum to completely relax the stenosis; posterior rectal incision refers to making a longitudinal incision 2.5 cm above the anal verge from the lower sacrum, separating the subcutaneous tissue, sacrococcygeal fascia, and perirectal tissue layer by layer to expose the posterior rectal wall, and then making a longitudinal incision in the posterior rectal wall to remove or cut the scar tissue of the stenotic segment; seton technique involves hanging a silk thread on the stenotic part, ligating it tightly, and slowly cutting the stenosis to relax the rectal wall; for long tubular stenosis with a large area of ​​invasion, partial rectal resection and anastomosis or rectal resection and pull-out surgery can be performed; for extensive stenosis of the rectum and anal canal, abdominoperineal rectal resection is performed.

[0005] While existing methods can alleviate the condition to some extent, they still have some technical limitations, as follows: ① Mechanical dilation therapy is difficult to cure and has a high recurrence rate, requiring repeated treatments, which leads to poor patient compliance, psychological and physiological difficulties in adaptation, and impacts quality of life. In addition, it is only applicable to mild benign stenosis, limiting its scope of application.

[0006] ② There is a risk of stent migration after stent placement. After migration, the stent can compress the intestine, leading to intestinal necrosis, perforation and bleeding. It is often used for symptomatic treatment of short-term rectal stenosis and is prone to falling out.

[0007] ③ Endoscopic anastomotic incision is a technically demanding procedure, requiring endoscopists to possess precise surgical skills and a strong understanding of anatomy. It is not suitable for patients with serious underlying diseases, coagulation disorders, or poor bowel preparation. It is also costly and has a high risk of restenosis.

[0008] ④ Surgical treatment is highly invasive, with risks of complications such as bleeding, infection, intestinal perforation, and anastomotic leakage during and after the operation. Some surgical procedures may lead to anal function damage, fecal incontinence, or permanent stoma, affecting the patient's quality of life. In addition, the surgical recovery period is long, the medical cost is high, and the requirements for the patient's basic physical condition are high. It is not suitable for patients with serious underlying diseases or poor tolerance.

[0009] Therefore, how to propose a transanal elliptical magnetic compression and unblocking component for treating rectal stenosis and its usage method has become a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0010] To address at least one technical problem in the background art, the present invention provides a transanal elliptical magnetic compression and unblocking component for treating rectal stenosis and its method of use. Through structural optimization, the passability and compression accuracy of the stenotic segment are improved, solving the problem of rectal stenosis for patients and improving their quality of life.

[0011] To achieve the above objectives, the present invention provides a transanal elliptical annular magnetic compression and unblocking component for treating rectal stenosis, comprising: an elliptical shell A, an elliptical shell B, a magnet component A, and a magnet component B. The magnet component A is embedded in the elliptical shell A, and the magnet component B is embedded in the elliptical shell B. Under the action of the magnet component A and the magnet component B, the elliptical shell A and the elliptical shell B are attracted together, and the shapes of the elliptical shell A and the elliptical shell B are adapted to each other.

[0012] Furthermore, both magnet assembly A and magnet assembly B are high energy product N52 type sintered NdFeB magnets with a titanium nitride coating on the surface.

[0013] Furthermore, both the elliptical shell A and the elliptical shell B are made of ABS plastic, with a biodegradable coating on the surface, and anti-inflammatory drug microspheres are encapsulated within the coating.

[0014] Furthermore, for mild rectal stenosis, the elliptical shell A is an overall elliptical cylinder with a major axis of 30mm, a minor axis of 15mm, and a height of 4mm. At the center of the elliptical cylinder is an elliptical recess with a major axis of 14mm and a minor axis of 11mm, the major and minor axes of which coincide with the major and minor axes of the overall large ellipse. The major axis of the large ellipse is divided into two segments by a smaller ellipse. Two circles with a radius of 3.5mm are drawn with the midpoint of these two segments as the center. This is the location of a cylindrical magnet A with a radius of 3.5mm and a height of 3mm. The magnet A is encapsulated within the elliptical shell A, and the upper and lower ABS plastic sections of the magnet A are each [thickness missing]. 0.5mm; Four anti-slip point layout: extending along the long axis of the small ellipse and intersecting the circle, a horizontal line is drawn at the midpoint of the line connecting the small ellipse and the circle, intersecting the vertical tangent of the circle and the vertical tangent of the small ellipse at two points, the midpoint of the line connecting the two points is the anti-slip positioning point, four anti-slip points are symmetrically distributed in the four quadrants on the elliptical magnetic pressing assembly; at the positioning point there is a frustum-shaped protrusion 3 with a lower bottom diameter of 1mm and an upper bottom diameter of 0.3mm; at both ends of the short axis of the elliptical shell A, there is a slot 4 with a radius of 0.5mm and a length of 2mm, and the slot is perpendicular to the height direction of the elliptical shell A; The magnet assembly B is encapsulated in an elliptical shell B. The elliptical shell B has four cylindrical slots with a radius of 0.5 mm and a depth of 4 mm, which are opposite to the frustum-shaped protrusions. Each end of the short axis of the elliptical shell B has a slot with a radius of 0.5 mm and a length of 2 mm, and the slots are perpendicular to the height direction of the elliptical shell B.

[0015] Furthermore, for moderate to severe rectal stenosis, the elliptical shell A is an overall elliptical column with a major axis of 30mm, a minor axis of 10mm, and a height of 4mm. An elliptical recess with a major axis of 12mm and a minor axis of 8mm is located at the center of the elliptical column. The major and minor axes of the inner ellipse are both increased by 0.4mm, forming an elliptical ring with the elliptical recess, and the elliptical ring protrudes upwards by 0.5mm. At the midpoint of the line connecting the major axes of the outer and inner ellipses, a cylindrical protrusion with a diameter of 1mm and a height of 0.4mm is formed. The major and minor axes of the inner ellipse are both increased by 0.7mm, and the outer ellipse is reduced by 0.5mm, intersecting to form a crescent shape, which is the location of the 3mm thick crescent-shaped magnet A. The magnet A is encapsulated in the elliptical shell A, with the top and bottom ABS plastic of magnet A each 0.5mm thick. At each end of the minor axis of the elliptical shell A, there is a slot with a radius of 0.5mm and a length of 1mm, and the slots are perpendicular to the height direction of the elliptical shell A. An elliptical recess with a major axis of 12mm and a minor axis of 8mm is provided at the center of magnet assembly B. Both the major and minor axes of the elliptical recess are increased by 0.5mm, and an annular groove is formed by a 0.8mm inward indentation from the elliptical surface of magnet assembly B. The elliptical shell B has two inverted frustum recesses with an upper bottom surface of 1mm, a lower bottom surface of 2mm, and a height of 0.4mm, which are opposite to the cylindrical protrusion. The magnet assembly B is encapsulated in the elliptical shell B. At each end of the minor axis of the elliptical shell B, there is a slot with a radius of 0.5mm and a length of 1mm, and the slots are perpendicular to the height direction of the elliptical shell B.

[0016] A method for using an anal elliptical magnetic compression and unblocking component for treating rectal stenosis involves using tweezers to insert the elliptical shell B containing the encapsulated magnet component B into the stenotic segment of the rectum, then inserting the elliptical shell A containing the encapsulated magnet component A into the area where the elliptical shell B is located, thereby assembling the elliptical shell A and the elliptical shell B to compress and fix the stenotic tissue, and then removing the tweezers.

[0017] Furthermore, for mild stenosis, the hook-shaped structure of the forceps tip is embedded in two circular grooves inside the short axis of the elliptical shell B externally. The forceps hold the elliptical shell B in an open state, and after being lubricated with paraffin oil, the elliptical shell B is inserted through the anus. Taking advantage of the small cross-sectional area of ​​the elliptical short axis, the elliptical shell B is placed into the proximal end of the stenosis. The insertion depth is adjusted according to the positioning scale. After the elliptical shell B crosses the stenotic segment, the forceps are withdrawn, keeping the forceps tip open. The angle of the forceps is adjusted so that the long axis of the elliptical shell B is perpendicular to the long axis of the intestine, while the stenotic intestinal tissue is tightly attached to one elliptical surface of the component. The elliptical shell A is then inserted into the forceps through the forceps handle, with the protruding surface facing the forceps tip. The elliptical shell A and elliptical shell B automatically align under the action of magnetic force, and the four protrusions are inserted into the four grooves under the action of magnetic attraction, achieving compression and fixation of the stenotic tissue. The forceps tip is closed, the forceps are removed, and the procedure is complete.

[0018] Furthermore, for moderate to severe stenosis, the stenotic segment of the rectum is longitudinally incised to allow passage through the minimum cross-section of the elliptical shell B. Externally, the hook-shaped structure of the forceps tip is embedded into two circular grooves inside the short axis of the elliptical shell B, with the grooved side of the ellipse facing the tail of the forceps. The forceps are held in an open position, and after lubrication with paraffin oil, the elliptical shell B is inserted through the anus. Utilizing the small cross-sectional area of ​​the elliptical's short axis, the elliptical shell B is placed proximally to the stenosis. The insertion depth is adjusted according to the positioning scale. After the elliptical shell B crosses the stenotic segment... Retract the forceps, keeping the forceps tips open. Adjust the forceps angle so that the long axis of the elliptical magnetic ring is perpendicular to the long axis of the intestine, while the narrowed intestinal tissue adheres tightly to one elliptical surface of the elliptical shell B. Insert the elliptical shell A through the forceps handle, with the protruding surface facing the forceps tip. Under the influence of the magnetic field, elliptical shell A and elliptical shell B automatically align. The central protruding ring first squeezes, cuts, and positions the narrowed segment, while the protrusions at both ends of the long axis then precisely position it, achieving compression and fixation of the narrowed tissue. Close the forceps tips, remove the forceps, and you are done.

[0019] The beneficial effects of this invention are as follows: 1. Strong structural adaptability: The elliptical design specifically addresses the problem of rectal stenosis. The short axis facilitates passage through narrow segments, while the long axis ensures the shape of the anastomosis and the pressing area.

[0020] 2. It provides individualized and precise treatment for mild and moderate to severe rectal stenosis. When the component is difficult to place, the longitudinal incision of the stenotic tissue (in the lithotomy position) is also within the compression range of the component, which will eventually become ischemic, necrotic and fall off without affecting normal tissue.

[0021] 3. The design features frustum-shaped and cylindrical protrusions and cylindrical frustum-shaped grooves, which not only tightly grip narrow tissues to prevent slippage, but also allow the protrusions to easily slide into the grooves for precise positioning and alignment.

[0022] 4. For components with moderate to severe stenosis, the central protruding ring is 0.5mm higher than the elliptical surface, which can first compress and locate the stenotic tissue. The pressure here is higher than in other places, causing the stenotic tissue in this area to undergo ischemia and necrosis first, forming a gradient compression, and quickly solving the problem of patients having difficulty defecating due to stenosis.

[0023] 5. Anti-inflammatory and biocompatibility optimization: The biodegradable coating combined with anti-inflammatory drug microspheres not only matches the tissue healing cycle, but also inhibits local inflammation and scar hyperplasia, reduces the risk of restenosis, and improves treatment safety.

[0024] 6. Stable and reliable therapeutic effect: The magnet has a uniform magnetic field, strong magnetic force, and sufficient compression area, which can effectively promote ischemic remodeling of the stenotic segment and form a stable anastomosis. Compared with traditional treatment methods, it has lower requirements for patients, does not require general anesthesia, has significant advantages of minimally invasive surgery, and has fast postoperative recovery and fewer complications. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the elliptical shell A of the present invention for mild rectal stenosis; Figure 2 This is a schematic diagram of the elliptical shell B of the present invention for mild rectal stenosis; Figure 3 This is a schematic diagram of the elliptical shell A of the present invention for moderate to severe rectal stenosis; Figure 4 This is a schematic diagram of the elliptical shell B of the present invention for moderate to severe rectal stenosis.

[0026] In the figure: 1-Elliptical shell A; 2-Elliptical shell B; 3-Protrusion; 4-Groove; 5-Cylindrical groove; 6-Concave; 7-Ring; 8-Annular groove; 9-Dent; 10-Magnet assembly A; 11-Magnet assembly B. Detailed Implementation

[0027] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate for the embodiments of this application described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0029] In this application, the terms "upper," "lower," "left," "right," "front," "rear," "top," "bottom," "inner," "outer," "middle," "vertical," "horizontal," "lateral," and "longitudinal" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are primarily for the purpose of better describing this application and its embodiments, and are not intended to limit the indicated device, element, or component to having a specific orientation, or to be constructed and operated in a specific orientation.

[0030] Furthermore, in addition to indicating location or positional relationship, some of the aforementioned terms may also have other meanings. For example, the term "above" may also be used in some cases to indicate a certain dependency or connection relationship. Those skilled in the art can understand the specific meaning of these terms in this application based on the specific circumstances.

[0031] Furthermore, the terms "installation," "setup," "equipped with," "connection," "linking," and "socketing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral structure; 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, or an internal connection between two devices, components, or parts. Those skilled in the art can understand the specific meaning of these terms in this application based on the specific circumstances.

[0032] To achieve the above objectives, the present invention provides a transanal elliptical annular magnetic compression and unblocking component for treating rectal stenosis, comprising: an elliptical shell A1, an elliptical shell B2, a magnet component A, and a magnet component B. The magnet component A is embedded in the elliptical shell A1, and the magnet component B is embedded in the elliptical shell B2. Under the action of the magnet component A1 and the magnet component B1, the elliptical shell A1 and the elliptical shell B2 are attracted together, and the shapes of the elliptical shell A1 and the elliptical shell B2 are adapted to each other.

[0033] To further optimize the technical solution, both magnet components A10 and B11 are high-energy-product N52 type sintered neodymium iron boron magnets with titanium nitride coating on the surface. The magnetization direction is radially magnetized along the height of magnet components A and B.

[0034] To further optimize the technical solution, both the elliptical shells A1 and B2 are made of ABS plastic, with a biodegradable coating on the surface (the LA / GA ratio is optimized according to the pressing time). Anti-inflammatory drug microspheres (such as dexamethasone) are encapsulated within the coating. The biodegradable coating can be PLGA, PDA (polydopamine), PLLA, etc.

[0035] In one embodiment, reference Figure 1 and Figure 2For mild rectal stenosis, the elliptical shell A1 is an overall elliptical cylinder with a major axis of 30mm, a minor axis of 15mm, and a height of 4mm. At the center of the elliptical cylinder is an elliptical recess 6 with a major axis of 14mm and a minor axis of 11mm. The major and minor axes of the recess are consistent with the major and minor axes of the overall large ellipse (the external overall shape is a large ellipse, and the internal recess is a small ellipse). The major axis of the large ellipse is divided into two segments by the small ellipse. Two circles with a radius of 3.5mm are drawn with the midpoint of the two segments as the center. This is the location of the cylindrical magnet A with a radius of 3.5mm and a height of 3mm. The magnet A is encapsulated in the elliptical shell A1, with the top and bottom ABS plastic sections each 0.5mm thick. Four anti-slip points are arranged as follows: extending along the major axis of the small ellipse and intersecting the circle; a horizontal line is drawn at the midpoint of the line connecting the small ellipse and the circle, and these points are vertically tangent to the circle. The vertical tangent of the line and the small ellipse intersects at two points. The midpoint of the line connecting the two points is the anti-slip positioning point. Four anti-slip points are symmetrically distributed in the four quadrants of the elliptical magnetic pressing component. At the positioning point, there is a frustum-shaped protrusion 3 with a lower bottom diameter of 1 mm and an upper bottom diameter of 0.3 mm. Each end of the short axis of the elliptical shell A1 is provided with a slot 4 with a radius of 0.5 mm and a length of 2 mm, and the slot is perpendicular to the height direction of the elliptical shell A1. The magnet component B is encapsulated in the elliptical shell B2. The elliptical shell B2 has four cylindrical slots 5 with a radius of 0.5 mm and a depth of 4 mm, which are opposite to the position of the frustum-shaped protrusion 3. Each end of the short axis of the elliptical shell B2 is provided with a slot 4 with a radius of 0.5 mm and a length of 2 mm, and the slot is perpendicular to the height direction of the elliptical shell B2.

[0036] In another embodiment, reference Figure 3 and Figure 4For moderate to severe rectal stenosis, the elliptical shell A1 is an overall elliptical column with a major axis of 30mm, a minor axis of 10mm, and a height of 4mm. At the center of the elliptical column is an elliptical recess 6 (inner ellipse) with a major axis of 12mm and a minor axis of 8mm. The major and minor axes of the elliptical recess 6 are both increased by 0.4mm, forming an elliptical ring 7 with the elliptical recess, which protrudes upwards by 0.5mm. At the midpoint of the line connecting the major axes of the outer and inner ellipses, a cylindrical protrusion 3 with a diameter of 1mm and a height of 0.4mm is formed. The major and minor axes of the inner ellipse are both increased by 0.7mm, while the outer ellipse is reduced by 0.5mm, intersecting to form a crescent shape. This is the location of the 3mm thick crescent-shaped magnet A. The magnet A is encapsulated within the elliptical shell A1, with the top and bottom ABS plastic sections of magnet A each 0.5mm thick. The elliptical shell A1 has a slot 4 with a radius of 0.5 mm and a length of 1 mm at each end of its minor axis, and the slot 4 is perpendicular to the height direction of the elliptical shell A. At the center of the magnet assembly B, there is an elliptical recess 6 with a major axis of 12 mm and a minor axis of 8 mm. Both the major and minor axes of the elliptical recess 6 are increased by 0.5 mm, forming an annular groove 8 formed by a 0.8 mm inward indentation from the elliptical surface of the magnet assembly B. The elliptical shell B2 has two inverted frustum recesses 9 with an upper bottom surface of 1 mm, a lower bottom surface of 2 mm, and a height of 0.4 mm, opposite to the cylindrical protrusion. The elliptical shell B2 also has a slot 4 with a radius of 0.5 mm and a length of 1 mm at each end of its minor axis, and the slot 4 is perpendicular to the height direction of the elliptical shell B2. The magnet assembly B is encapsulated within the elliptical shell B2.

[0037] In this invention, the dimensions and thickness of magnet assembly A and magnet assembly B can be adjusted according to the required precision under actual conditions.

[0038] In existing magnetic compression devices used to treat benign intestinal strictures, after the anastomosis is formed, local inflammation and fibrosis are prone to occur at the anastomosis site, which may lead to restenosis. Currently, there is a lack of magnetic compression devices that can simultaneously achieve localized sustained release of anti-inflammatory drugs during the compression process. Elliptical shells A and B encapsulate magnetic components A and B and provide structural support. A biodegradable coating is applied to the outer surface of elliptical shells A and B, with drug-loaded microspheres dispersed within the PLGA coating. The drug-loaded microspheres use PLGA as the wall material and encapsulate anti-inflammatory active ingredients internally. Furthermore, the outer surfaces of elliptical shells A and B undergo surface activation treatment (such as plasma treatment / chemical etching / coating with a silane coupling agent underlayer) to enhance the interfacial adhesion with the PLGA coating. The degradation cycle of the PLGA coating matches the tissue healing cycle (5-7 days), slowly releasing anti-inflammatory drugs during degradation, inhibiting scar hyperplasia, reducing the risk of restenosis, and improving biocompatibility. The magnetic ring is expelled from the anus after 7 days. The slots at the short axes of all components are for inserting forceps to open and insert the parts. The outer elliptical design takes advantage of the small cross-sectional area of ​​the short axis, facilitating passage through narrow sections; the magnetic components at both ends of the long axis ensure that a sufficient, nearly circular anastomosis is formed after compression, adapting to the intestinal anatomy; the inner circular or elliptical design allows patients to maintain relatively unobstructed bowel movements even with a liquid diet or enema (Milsom-Mazier classification: mild stenosis means that a lubricated index finger can pass through the narrow section; according to clinical judgment, a passage with the narrowest side greater than or equal to 10mm can ensure unobstructed bowel movements); the elliptical shell A and the magnetic The four protrusions and recesses on the elliptical surface of component A serve to position and prevent the compressed tissue from slipping out. The elliptical shell B and the annular protrusions of magnet component B act as a guillotine during compression, relying on magnetic attraction to quickly compress the narrowed tissue, rapidly resolving moderate to severe constipation. The smaller protrusions on both sides of the long axis, after the central annular compression, serve to position and prevent tissue slippage. The elliptical shell B, paired with magnet component B, features an inverted frustum-shaped recess design that allows the small cylinders of the protrusions to easily locate and precisely position themselves within the recess. For moderate to severe constipation, the crescent-shaped magnet component B maximizes the use of its remaining area to ensure magnetic attraction.

[0039] The symmetrical layout method of the anti-slip points of the present invention is as follows: I. For mild stenosis Extend along the long axis of the small ellipse to intersect with the circle. Draw a horizontal line at the midpoint of the line connecting the small ellipse and the circle. The line intersects the vertical tangent of the circle and the vertical tangent of the inner ellipse at two points. The midpoint of the line connecting these two points is the anti-slip positioning point. Four anti-slip points are symmetrically distributed in the four quadrants of the elliptical magnetic pressing component.

[0040] II. For moderate to severe stenosis

[0041] The major and minor axes of the inner ellipse are both increased by 0.4 mm, forming an elliptical ring with the concave ellipse. The elliptical ring protrudes upward by 0.5 mm. At the midpoint of the line connecting the major axes of the outer and inner ellipses, there is a cylindrical protrusion with a diameter of 1 mm and a height of 0.4 mm.

[0042] The present invention also provides a method for using an anal elliptical magnetic compression and unblocking component for treating rectal stenosis. The elliptical shell B containing the encapsulated magnet component B is inserted into the stenotic segment of the rectum using tweezers. Then, the elliptical shell A containing the encapsulated magnet component A is inserted into the area where the elliptical shell B is located, so that the elliptical shell A and the elliptical shell B are assembled to achieve compression and fixation of the stenotic tissue. The tweezers are then removed.

[0043] In one embodiment, for mild stenosis, the patient is in the lithotomy position. Externally, the hook-shaped structure of the forceps tip is embedded into two circular grooves inside the short axis of an elliptical shell B. The forceps hold the elliptical shell B in an open state. After lubrication with paraffin oil, the elliptical shell B is inserted through the anus. Utilizing the small cross-sectional area of ​​the elliptical short axis, the elliptical shell B is placed proximal to the stenosis. The insertion depth is adjusted according to the positioning scale. After the elliptical shell B crosses the stenotic segment, the forceps are withdrawn, keeping the forceps tip open. The angle of the forceps is adjusted so that the long axis of the elliptical shell B is perpendicular to the long axis of the intestine, while the stenotic intestinal tissue adheres tightly to one elliptical surface of the component. The elliptical shell A is then inserted through the forceps handle, with the protruding surface facing the forceps tip. The elliptical shell A and elliptical shell B automatically align under the action of a magnetic field. The four protrusions are inserted into the four grooves under magnetic attraction, achieving compression and fixation of the stenotic tissue. The forceps tip is closed, and the forceps are removed.

[0044] In another embodiment, for moderate to severe stenosis, the patient is in the lithotomy position. The stenotic segment of the rectum is longitudinally incised to allow passage through the minimum cross-section of the elliptical shell B. Externally, the hook-shaped structure of the forceps tip is embedded into two circular grooves inside the short axis of the elliptical shell B, with the grooved side of the ellipse facing the tail of the forceps. The forceps are held in an open position, and after being lubricated with paraffin oil, the elliptical shell B is inserted through the anus. Utilizing the small cross-sectional area of ​​the elliptical's short axis, the elliptical shell B is placed proximal to the stenosis. The insertion depth is adjusted according to the positioning scale. After the elliptical shell B crosses the stenotic segment, the forceps are withdrawn. Keeping the forceps tips open, adjust the forceps angle so that the long axis of the elliptical magnetic ring is perpendicular to the long axis of the intestine, while the narrowed intestinal tissue is tightly attached to one elliptical surface of the elliptical shell B. Insert the elliptical shell A through the forceps handle, with the protruding surface facing the forceps tip. The elliptical shell A and elliptical shell B automatically align under the magnetic force. The central protruding ring first squeezes, cuts, and positions the narrowed segment, and then the protrusions at both ends of the long axis precisely position it, achieving compression and fixation of the narrowed tissue. Close the forceps tips, remove the forceps, and you are done.

[0045] This invention provides a transanal magnetic compression device adapted to different degrees and types of rectal stenosis. Through structural optimization, it improves the passageability and compression accuracy of the stenotic segment, solving the problem of rectal stenosis and improving patients' quality of life. Optimized magnet surface coating and structural design enhance biocompatibility, inhibit local inflammation and scar hyperplasia, and reduce recurrence rates. The simplified operation process lowers the technical threshold, has low requirements for patients' physical conditions, reduces surgical trauma and patient suffering, lowers medical costs, eliminates the need for hospitalization, and facilitates clinical application. It also enables individualized adaptation of device parameters to meet the treatment needs of different degrees of stenosis and anatomical features.

[0046] The above description is merely a preferred embodiment of the present invention and does not constitute any limitation on the technical scope of the present invention. Therefore, any minor modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention shall still fall within the scope of the technical solution of the present invention.

Claims

1. A transanal elliptical ring magnetic squeeze through assembly for treating rectal stricture, characterized in that, include: Elliptical shell A, elliptical shell B, magnet assembly A and magnet assembly B, wherein magnet assembly A is embedded in elliptical shell A and magnet assembly B is embedded in elliptical shell B. Under the action of magnet assembly A and magnet assembly B, elliptical shell A and elliptical shell B are attracted together, and the shapes of elliptical shell A and elliptical shell B are adapted to each other.

2. The transanal elliptical magnetic compression and unblocking component for treating rectal stenosis as described in claim 1, characterized in that, Both magnet assembly A and magnet assembly B are high energy product N52 type sintered NdFeB magnets with a titanium nitride coating on the surface.

3. The transanal elliptical annular magnetic compression and unblocking component for treating rectal stenosis as described in claim 2, characterized in that, Both the elliptical shell A and the elliptical shell B are made of ABS plastic and covered with a biodegradable coating, with anti-inflammatory drug microspheres encapsulated within the coating.

4. The transanal elliptical magnetic compression and unblocking component for treating rectal stenosis as described in claim 3, characterized in that, For mild rectal stenosis, the elliptical shell A is an overall elliptical cylinder with a major axis of 30mm, a minor axis of 15mm, and a height of 4mm. At the center of the elliptical cylinder is an elliptical recess with a major axis of 14mm and a minor axis of 11mm, the major and minor axes of which coincide with the major and minor axes of the overall larger ellipse. The major axis of the larger ellipse is divided into two segments by a smaller ellipse. Two circles with a radius of 3.5mm are drawn, centered at the midpoint of these two segments. This is the location of a cylindrical magnet A with a radius of 3.5mm and a height of 3mm. The magnet A is encapsulated within the elliptical shell A, with the top and bottom layers of ABS plastic each 0mm thick. 0.5mm; Four anti-slip point layout: Extend along the long axis of the small ellipse and intersect with the circle. Draw a horizontal line at the midpoint of the line connecting the small ellipse and the circle. The horizontal line intersects the vertical tangent of the circle and the vertical tangent of the small ellipse at two points. The midpoint of the line connecting the two points is the anti-slip positioning point. Four anti-slip points are symmetrically distributed in the four quadrants of the elliptical magnetic pressing assembly. There is a frustum-shaped protrusion with a bottom diameter of 1mm and an top diameter of 0.3mm at the positioning point. Each end of the short axis of the elliptical shell A is provided with a slot with a radius of 0.5mm and a length of 2mm, and the slot is perpendicular to the height direction of the elliptical shell A. The magnet assembly B is encapsulated in an elliptical shell B. The elliptical shell B has four cylindrical slots with a radius of 0.5 mm and a depth of 4 mm, which are opposite to the frustum-shaped protrusions. Each end of the short axis of the elliptical shell B has a slot with a radius of 0.5 mm and a length of 2 mm, and the slots are perpendicular to the height direction of the elliptical shell B.

5. The transanal elliptical magnetic compression and unblocking component for treating rectal stenosis as described in claim 3, characterized in that, For moderate to severe rectal stenosis, the elliptical shell A is an overall elliptical column with a major axis of 30mm, a minor axis of 10mm, and a height of 4mm. At the center of the elliptical column is an elliptical recess (inner ellipse) with a major axis of 12mm and a minor axis of 8mm. The major and minor axes of the inner ellipse are both increased by 0.4mm, forming an elliptical ring with the elliptical recess, which protrudes upwards by 0.5mm. At the midpoint of the line connecting the major axes of the outer and inner ellipses, a cylindrical protrusion with a diameter of 1mm and a height of 0.4mm is formed. The major and minor axes of the inner ellipse are both increased by 0.7mm, while the outer ellipse is reduced by 0.5mm, intersecting to form a crescent shape. This is the location of the 3mm thick crescent-shaped magnet A. The magnet A is encapsulated within the elliptical shell A, with the top and bottom ABS plastic sections each 0.5mm thick. At each end of the minor axis of the elliptical shell A is a slot with a radius of 0.5mm and a length of 1mm, perpendicular to the height direction of the elliptical shell A. An elliptical recess with a major axis of 12mm and a minor axis of 8mm is provided at the center of magnet assembly B. Both the major and minor axes of the elliptical recess are increased by 0.5mm, and an annular groove is formed by a 0.8mm inward indentation from the elliptical surface of magnet assembly B. The elliptical shell B has two inverted frustum recesses with an upper bottom surface of 1mm, a lower bottom surface of 2mm, and a height of 0.4mm, which are opposite to the cylindrical protrusion. The magnet assembly B is encapsulated in the elliptical shell B. At each end of the minor axis of the elliptical shell B, there is a slot with a radius of 0.5mm and a length of 1mm, and the slots are perpendicular to the height direction of the elliptical shell B.

6. A method of using a transanal elliptical annular magnetic compression and unblocking component for treating rectal stenosis, characterized in that, Using tweezers, insert the elliptical shell B of the encapsulated magnet component B into the rectal stenosis. Then, insert the elliptical shell A of the encapsulated magnet component A into the area where the elliptical shell B is located, so that the elliptical shell A and the elliptical shell B are assembled, thereby compressing and fixing the stenotic tissue. Remove the tweezers.

7. The method of using the transanal elliptical annular magnetic compression and unblocking component for treating rectal stenosis as described in claim 6, characterized in that, For mild stenosis, the hook-shaped structure of the forceps tip is embedded in two circular grooves inside the short axis of the elliptical shell B externally. The forceps hold the elliptical shell B in an open state and, after being lubricated with paraffin oil, deliver the elliptical shell B through the anus. Taking advantage of the small cross-sectional area of ​​the elliptical short axis, the elliptical shell B is placed into the proximal end of the stenosis. The insertion depth is adjusted according to the positioning scale. After the elliptical shell B crosses the stenotic segment, the forceps are withdrawn, keeping the forceps tip open. The angle of the forceps is adjusted so that the long axis of the elliptical shell B is perpendicular to the long axis of the intestine, while the stenotic intestinal tissue is tightly attached to one elliptical surface of the component. The elliptical shell A is then inserted into the forceps through the forceps handle, with the protruding surface facing the forceps tip. The elliptical shell A and elliptical shell B automatically align under the action of a magnetic field. The four protrusions are inserted into the four grooves under the action of magnetic attraction, achieving compression and fixation of the stenotic tissue. Close the tip of the tweezers, remove the tweezers, and you're done.

8. A method of using the transanal elliptical ring shaped magnetic squeeze through assembly for treating rectal stricture as claimed in claim 6 wherein, For moderate to severe stenosis, the stenotic segment of the rectum is longitudinally incised to allow passage through the minimum cross-section of the elliptical shell B. Externally, the hook-shaped structure of the forceps tip is embedded into two circular grooves inside the short axis of the elliptical shell B, with the grooved side of the ellipse facing the tail of the forceps. The forceps are held in an open position, and after lubrication with paraffin oil, the elliptical shell B is inserted through the anus. Utilizing the small cross-sectional area of ​​the elliptical's short axis, the elliptical shell B is placed proximally to the stenosis. The insertion depth is adjusted according to the positioning scale. After the elliptical shell B crosses the stenotic segment, it is returned to its original position. Remove the forceps, keeping the forceps tips open. Adjust the forceps angle so that the long axis of the elliptical magnetic ring is perpendicular to the long axis of the intestine, while the narrowed intestinal tissue adheres tightly to one elliptical surface of the elliptical shell B. Insert the elliptical shell A through the forceps handle, with the protruding surface facing the forceps tip. Under the influence of the magnetic field, elliptical shell A and elliptical shell B automatically align. The central protruding ring first squeezes, cuts, and positions the narrowed segment, while the protrusions at both ends of the long axis then precisely position it, achieving compression and fixation of the narrowed tissue. Close the forceps tips, remove the forceps, and you are done.

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