A disintegrable shell magnetic compression anastomat suitable for rectal anastomosis

Abstract

The application discloses a disintegrable shell magnetic pressing anastomat suitable for rectal anastomosis, and relates to the technical field of medical devices.The technical scheme points are as follows: the anastomat comprises an upper protective cover, an upper shell, a lower shell and a lower protective cover, wherein the upper shell and the lower shell are internally embedded with magnets, the protective cover is detachably buckled with the shell, each shell component is made of a PLGA disintegrable material, the magnets are neodymium iron boron drum-shaped magnets, the surfaces of the magnets are provided with double protective layers, the shell is provided with a fixed magnet column, an intestinal wall needle hole and a positioning structure, and a drainage channel is formed after the shell is closed.The application avoids metal residues through the disintegrable shell, does not need secondary surgery, completes intestinal anastomosis through magnetic closing, reduces magnet corrosion through a sealing design, is convenient to operate and minimally invasive, is suitable for rectal physiological characteristics, effectively improves anastomosis safety and effect, reduces patient pain, shortens recovery time, and has high clinical application value.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a disintegratable magnetic compression stapler suitable for rectal anastomosis. Background Technology

[0002] Colorectal cancer is a highly prevalent malignant tumor worldwide, and surgery is the primary treatment method. Intestinal anastomosis techniques have been developed for over a century, and manual suturing and mechanical anastomosis techniques are relatively mature. However, low rectal anastomosis, due to its special anatomical location and limited operating space, has always been a challenging area in surgery.

[0003] Magnetic compression anastomosis, first proposed in the 1980s, utilizes the attractive force of magnets to achieve tissue compression anastomosis, theoretically avoiding problems such as needle leakage in traditional anastomosis techniques. While magnetic surgery has developed rapidly in China in recent years, the clinical application of magnetic compression anastomosis still faces key bottlenecks. Although the traditional two-instrument anastomosis technique (DST) has been continuously improved since its invention in 1908, the inherent defects of staple anastomosis have not been fundamentally resolved.

[0004] Currently, low rectal surgery mainly employs the traditional dual-instrument anastomosis technique (DST), whose basic principle is serosa-serosa stapled anastomosis. This technique has the following drawbacks: First, the incidence of anastomotic leakage is high. Due to factors such as needle leakage, uncertain staple formation, tissue foreign body reaction, and the mechanical changes in biological tissues after stapled anastomosis, the probability of anastomotic leakage can reach as high as 24%. Second, the operating space is limited in mid-to-low rectal surgery, making it difficult to add needles to the seromuscular layer, resulting in uncertain anastomotic effects. Third, prophylactic ileostomy / colostomy is often required to reduce the risk of anastomotic leakage, but prophylactic ileostomy is difficult for patients to accept, and a second surgery is required to close the stoma, causing significant inconvenience, economic and psychological stress for patients.

[0005] Although there have been sporadic cases and clinical trial reports of magnetic anastomosis devices in China in recent years, the following key issues remain: the magnetic anastomosis process cannot be precisely controlled, affecting surgical outcomes; the magnet surface has poor corrosion resistance in the complex intestinal environment, posing safety hazards; the magnet's discharge time is uncertain and uncontrollable, affecting postoperative recovery; and the effect of the magnet on electrosurgical procedures within the body is still unclear. While there have been sporadic reports of using a single magnet to address rectal anastomotic stenosis, no mature product has been commercialized due to the unresolved issues mentioned above.

[0006] In summary, the existing technology still has the following technical problems:

[0007] (1) Uncertain time of magnet expulsion: The time of expulsion of the whole magnet in the digestive tract is uncontrollable, which may cause retention or obstruction; (2) Poor corrosion resistance of magnet: Strong magnets such as neodymium iron boron are easily corroded in the complex environment of the intestine, resulting in a decrease in magnetic force or surface damage, which affects the anastomosis effect and biosafety; (3) Impact on electrosurgical operation: Magnets are conductive in the body. If electrosurgical instruments such as electrocautery are used after surgery, it may easily lead to local tissue burns or electrical damage.

[0008] Therefore, the present invention aims to provide a disintegrating shell magnetic compression stapler suitable for rectal anastomosis to solve the above-mentioned problems. Summary of the Invention

[0009] The purpose of this invention is to provide a disintegrating magnetic compression stapler suitable for rectal anastomosis. This invention achieves the ischemia-necrosis-healing process of the intestinal wall through magnetic compression, leaving no metal residue in the intestinal wall tissue, reducing the probability of anastomotic inflammation and stenosis. The disintegrating shell design allows the magnet to detach spontaneously in the later stages. The operation is minimally invasive and convenient, adapts to the physiological characteristics of the rectum, effectively improves the safety and effectiveness of anastomosis, reduces patient pain, shortens recovery time, and has high clinical application value.

[0010] The above-mentioned technical objective of the present invention is achieved through the following technical solution: a disintegratable magnetic compression stapler suitable for rectal anastomosis, comprising an upper protective cover, an upper shell, a lower shell, and a lower protective cover, wherein magnets are embedded inside the upper shell and the lower shell; the upper protective cover is detachably fastened to the upper shell, and the lower protective cover is detachably fastened to the lower shell, both serving to isolate the magnets from the intestinal environment; the upper shell and the lower shell are engaged by the magnetic attraction of the internal magnets, gradually realizing the ischemia-necrosis-healing process of the intestinal tract; the upper shell, the lower shell, the upper protective cover, and the lower protective cover are all made of disintegratable polymer biomaterials.

[0011] By adopting the above technical solution, the detachable protective cover can effectively isolate the magnet from the intestinal environment. This facilitates production and assembly, and effectively isolates the magnet from the intestinal environment, preventing the magnet from being corroded and contaminated by intestinal secretions and contents. At the same time, all outer shell components are made of disintegratable polymer biomaterials, which solves the problem of traditional anastomotic staple residues easily causing anastomotic inflammation and foreign body reactions, reducing patient pain and the risk of postoperative complications. The magnetic force of the magnet is used to achieve intestinal anastomosis, making the anastomosis process simple. Moreover, the dispersed magnet can gradually compress the intestinal tube according to the thickness of the intestinal wall, allowing the intestinal wall to gradually necrose and heal without the need for puncture or suturing damage to the intestinal tube. It is adapted to the special anatomical position of rectal anastomosis, making the operation convenient and safe.

[0012] The present invention is further configured such that the magnet is a drum-shaped magnet, which is embedded inside the upper and lower shells in an alternating arrangement of N and S poles.

[0013] By adopting the above technical solution, the magnet is set in a drum shape, which improves the longitudinal magnetic force of the magnet and avoids the problem of insufficient magnetic force of traditional spherical magnets. In addition, the dispersed magnet can avoid uneven anastomosis pressure caused by uneven thickness of the intestinal wall during the anastomosis process. The method of alternating N pole and S pole arrangement makes a uniform and stable magnetic attraction between the upper and lower shells, ensuring that the two sides of the intestinal tube are evenly clamped, avoiding excessive local pressure that could cause damage to the intestinal wall, or insufficient pressure that could cause leakage and poor healing at the anastomosis site. This is suitable for the characteristics of the rectal wall, which is thin and easily damaged.

[0014] The present invention is further configured such that: the magnet is a neodymium iron boron magnet, and its surface is sequentially plated with a titanium nitride corrosion-resistant layer and a parylene insulating layer.

[0015] By adopting the above technical solution and selecting neodymium iron boron magnets, which have strong magnetic force and high stability, sufficient clamping force can be achieved in a small volume to meet the stable fixation requirements of the intestinal segment during rectal anastomosis. Experimental demonstration shows that the burst pressure provided by the magnetic anastomosis device is higher than the burst pressure of the intestinal wall (about 75 mmHg). After the proximal and distal anastomoses are attracted, there is no need to add a needle to the seromuscular layer, which facilitates anastomosis operations in narrow spaces. The magnet surface is coated with a titanium nitride corrosion-resistant layer and a parylene insulating layer in sequence. The double protection can effectively isolate the magnet from the corrosion of weak alkaline substances and intestinal flora in the intestine, prolong the effective action time of the magnet in the body, and avoid the generation of toxic components after magnet corrosion that affect the biosafety of the instrument and the healing of the anastomosis. At the same time, the insulating layer can prevent abnormal electrical circuits from causing tissue damage during electrosurgical operations, thus improving the safety of use.

[0016] The present invention is further configured such that: the disintegrating polymeric biomaterial is polylactic acid-glycolic acid copolymer (PLGA), and the anastomosis device shell gradually disintegrates after being inserted into the body for 4 weeks, and completely disintegrates within 6 weeks.

[0017] By adopting the above technical solution, the disintegrating polymeric biomaterial was identified as polylactic acid-glycolic acid copolymer (PLGA). This material has good biocompatibility and degradability, is non-toxic, does not cause foreign body reactions, and will not harm intestinal tissue or the human body. The outer shell gradually disintegrates after 4 weeks of implantation and completely disintegrates within 6 weeks. This disintegration period exceeds the normal growth cycle of anastomotic tissue (1-2 weeks), which ensures the structural stability of the outer shell during anastomosis, providing continuous support and clamping force for intestinal healing. It also disintegrates in time after the anastomosis is completely healed and the anastomotic tissue tension is restored, eliminating the need for a second surgery to remove it, reducing postoperative pain and recovery time for patients. At the same time, the disintegration products can be naturally absorbed or excreted by the human body, with no residual risks.

[0018] The invention is further configured such that: both the upper and lower shells are provided with fixed magnet columns for positioning and fixing magnets; both the upper and lower shells are provided with fixed intestinal wall pinholes for suturing and fixing with the intestinal wall, and the pinhole diameter is 1.5~2.0mm.

[0019] By adopting the above technical solution, fixed magnet columns are set inside the upper and lower shells, which can accurately position and firmly fix the magnets, preventing the magnets from shifting or rotating during the anastomosis process, ensuring uniform magnetic force distribution, and guaranteeing the anastomosis effect. The shell surface is provided with pinholes for fixing the intestinal wall, and the diameter of the pinholes is limited to 1.5~2.0mm. This size is suitable for absorbable sutures, which makes it easy to suture and fix the anastomosis device components to the intestinal wall, preventing the anastomosis device from shifting or falling off during intestinal peristalsis, ensuring that the anastomosis is always in a stable clamped state. At the same time, the smaller pinhole size can reduce damage to the intestinal wall and reduce the risk of bleeding and infection at the pinhole.

[0020] The present invention is further configured such that after the upper shell and the lower shell are joined, a through-hole drainage channel is formed inside for the intestinal contents to pass through, and the diameter of the drainage channel is 10~15mm.

[0021] By adopting the above technical solution, the upper and lower shells are joined to form a through-hole drainage channel, and the diameter of the drainage channel is limited to 10~15mm. This size is suitable for the normal discharge of rectal contents and ensures the normal physiological function of the intestine during the anastomosis healing period.

[0022] The present invention is further configured such that: the magnetic force on the surface of a single magnet is 4000~6000 Gauss, the magnetic force on the contact surface with the intestine is 1500~3500 Gauss, the magnet diameter is 5~6mm, and the height is 5~6mm.

[0023] By adopting the above technical solution, the magnetic force on the surface of a single magnet is determined to be 4000~6000 Gauss, the magnetic force on the contact surface with the intestine is 1500~3500 Gauss, and the magnet diameter is 5~6mm and the height is 5~6mm. This size can reduce the volume of a single magnet while ensuring the magnetic force, which facilitates the sequential discharge of magnets after the outer shell disintegrates.

[0024] The present invention is further configured such that: the upper protective cover and the upper shell, and the lower protective cover and the lower shell are provided with sealing bosses at the fastening points, in order to enhance the sealing performance and prevent intestinal secretions from contacting the magnet.

[0025] By adopting the above technical solution, a sealing protrusion is set at the snap-fit ​​point between the protective cover and the shell, which can significantly enhance the sealing performance after snap-fitting. This effectively prevents intestinal secretions and contents from contacting the magnet, avoiding contamination and corrosion of the magnet, and extending the effective working time of the magnet. At the same time, the good sealing performance can prevent bacteria and foreign objects in the intestine from entering the gap between the protective cover and the shell, reducing the risk of infection around the anastomosis site. This provides a clean and stable environment for the magnet and the anastomosis operation, further improving the safety and reliability of the anastomosis, and adapting to the environmental characteristics of the rectum where there are many bacteria and infection is prone to occur.

[0026] The present invention also provides a method of using a disintegrating shell magnetic compression stapler suitable for rectal anastomosis, comprising the following steps:

[0027] S1. Component pre-assembly: Install the magnets into the fixed magnet posts of the upper and lower housings respectively, fasten the upper protective cover to the upper housing, fasten the lower protective cover to the lower housing, and check the sealing performance;

[0028] S2, Proximal Insertion: The pre-assembled upper protective cover and upper shell assembly are inserted into the proximal colon, and the assembly is sutured and fixed to the intestinal wall with absorbable sutures through the pinholes in the intestinal wall.

[0029] S3. Distal processing: After turning the distal intestinal tube out, the intestinal wall and the lower shell assembly are sutured and fixed to the distal intestinal wall through the fixation needle hole. The lower shell assembly is turned into the intestine. The distal anastomosis device is sent into the intestinal lumen through the delivery device to ensure that the intestinal tube is not twisted.

[0030] S4. Magnetic anastomosis: The upper and lower shells automatically align under magnetic force, clamping the intestinal walls on both sides and maintaining stable anastomosis pressure;

[0031] S5. Postoperative observation and disintegration: After the operation, the implantation of the stapler is observed regularly by X-ray or CT. The outer shell material gradually disintegrates in the body, and the magnet is excreted in pieces with the intestinal contents. There is no metal residue in the body.

[0032] By adopting the above technical solution, the method of use is clear, easy to operate, and adaptable to the clinical operation process of rectal anastomosis. It is convenient for medical staff to quickly master and implement. After the components are pre-assembled, the sealing performance is checked, which can identify faults in advance and avoid problems such as sealing failure and magnet displacement during operation. Absorbable sutures are used to fix the intestinal wall to the shell to prevent the anastomosis device from falling off due to intestinal peristalsis. In the long term, the magnetic pressure on the anastomosis surface of the intestinal segment may cause necrosis and dislodgement, thus avoiding foreign body residue. When the distal intestinal segment is returned to the abdominal cavity, it is emphasized that there should be no torsion to avoid postoperative intestinal obstruction caused by intestinal torsion. By regularly checking the anastomosis device for dislodgement through abdominal X-ray or CT after surgery, anastomotic abnormalities can be detected and treated in time, reducing the risk of postoperative complications. The magnet is naturally discharged with the feces, eliminating the need for secondary surgery, further improving the patient's postoperative comfort and recovery efficiency. The overall process takes into account the convenience, safety and effectiveness of operation.

[0033] In summary, the present invention has the following beneficial effects:

[0034] 1. This invention can improve the safety of anastomosis and reduce the risk of complications. By using disintegrating polymeric biomaterial (PLGA) to make the outer shell component, it can naturally disintegrate and be discharged after the anastomosis heals (gradually disintegrating over 4 weeks and completely disintegrating over 6 weeks), without the need for secondary surgery to remove it. This avoids inflammation and foreign body reactions caused by metal residue. The double protective layer on the magnet surface (titanium nitride corrosion-resistant layer and parylene insulating layer) can prevent the magnet from being corroded by intestinal secretions and producing harmful substances. At the same time, it avoids abnormal electrical circuits stimulating intestinal tissue. The sealing protrusion at the cover snap-fit ​​can block intestinal bacteria and secretions from contacting the magnet, reducing the corrosive stimulation of the magnet by intestinal bacteria and intestinal fluid. The size of the needle hole in the fixed intestinal wall is adapted to absorbable sutures, reducing intestinal wall damage and reducing the risk of needle hole bleeding and infection.

[0035] 2. This invention can ensure the accuracy and stability of anastomosis and improve the anastomosis effect. By using drum-shaped magnets with alternating N and S poles, uniform and stable magnetic clamping can be achieved between the upper and lower shells, avoiding damage or weak anastomosis caused by uneven local pressure on the intestinal wall. The fixed magnet column inside the shell can prevent the magnet from shifting or rotating, ensuring uniform magnetic force distribution. The magnet size (diameter 5~6mm, height 5~6mm) and magnetic parameters (surface 4000~6000 Gauss, intestinal contact surface 1500~3500 Gauss) are precisely matched, providing sufficient clamping force while avoiding rapid ischemia and necrosis of the intestinal wall.

[0036] 3. This invention optimizes the ease of operation, reduces patient pain, and the overall size of the stapler is small and adapted to the characteristics of rectal anatomy. It achieves intestinal alignment through the magnetic force of the magnet. The usage method is clear and easy to operate, making it easy for medical staff to master. The pre-assembly inspection of components and the emphasis on no twisting during distal intestinal repositioning are also included. The magnet is naturally discharged with the feces, shortening the recovery time of intestinal physiological function.

[0037] 4. This invention is adapted to the intestinal physiological environment, improving the quality of postoperative recovery. The internal drainage channel (10-15mm in diameter) ensures the normal discharge of intestinal contents, avoids stagnation and bloating, and maintains intestinal pressure balance. Magnetic compression can reduce the risk of leakage at the anastomosis and reduce friction and stimulation of intestinal contents on the anastomosis, providing a good environment for healing. All materials have good biocompatibility, are non-toxic, and do not cause foreign body reactions. Disintegration products can be discharged naturally without residual risks. The overall design fits the physiological characteristics of the rectum, which has a large number of bacteria, a fragile intestinal wall, and high intestinal pressure. It takes into account both the effectiveness of operation and the speed of postoperative physiological function recovery of patients, and has significant clinical application value in improving the quality of rectal anastomosis.

[0038] 5. The 5-6mm high shell design in this patent can reduce stress concentration in the anastomosis area and reduce the chance of anastomotic leakage. Related literature research shows that butyric acid, a metabolite of PLGA shell, can strengthen the intestinal barrier, inhibit related inflammatory pathways, repair colonic epithelium, and promote anastomotic healing after being metabolized by intestinal flora.

[0039] 6. The PLGA casing can prevent the magnet from being rapidly corroded in the complex environment of the intestines within a certain period of time, thus avoiding the biotoxicity caused by the corrosion of the magnet;

[0040] 7. Under the continuous clamping force of the magnet, the PLGA shell can be disintegrated more quickly, thus preventing the stapler from remaining in the intestine for too long. Attached Figure Description

[0041] Figure 1 This is a schematic diagram of the appearance of a disintegratable magnetic compression stapler with a magnetically compressed outer shell suitable for rectal anastomosis according to Embodiment 1 of the present invention;

[0042] Figure 2 This is a front cross-sectional view of a disintegratable magnetic compression stapler suitable for rectal anastomosis in Embodiment 1 of the present invention;

[0043] Figure 3 This is a schematic diagram of the upper protective cover in Embodiment 1 of the present invention;

[0044] Figure 4 This is a schematic diagram of the upper shell structure in Embodiment 1 of the present invention;

[0045] Figure 5 This is a schematic diagram of the lower shell structure in Embodiment 1 of the present invention;

[0046] Figure 6 This is a schematic diagram of the structure of the lower protective cover in Embodiment 1 of the present invention;

[0047] Figure 7 This is a schematic diagram of the structure of the upper or lower shell after the magnet is installed in Embodiment 1 of the present invention;

[0048] Figure 8 This is a surgical schematic diagram of a disintegrating shell magnetic compression stapler suitable for rectal anastomosis after being inserted into the proximal and distal rectum in Embodiment 1 of the present invention;

[0049] Figure 9 This is a flowchart illustrating the method of using a disintegrating shell magnetic compression stapler suitable for rectal anastomosis, as described in Embodiment 2 of the present invention.

[0050] Figure 10 This is a scatter plot showing the correlation between burst pressure and rise rate in Embodiment 3 of the present invention.

[0051] In the diagram: 1. Upper protective cover; 2. Upper shell; 3. Lower shell; 4. Magnet; 5. Lower protective cover; 6. Delivery device rotating interface; 7. Pinhole for fixing the intestinal wall; 8. Upper protective cover fixing post; 9. Upper shell fixing magnet post; 10. Lower shell fixing magnet post; 11. Lower protective cover fixing post; 12. Intraluminal drainage channel; 13. Proximal colon; 14. Distal colon. Detailed Implementation

[0052] The following is in conjunction with the appendix Figure 1-10 The present invention will be described in further detail below.

[0053] Example 1: A disintegrating shell magnetic compression stapler suitable for rectal anastomosis, such as Figures 1-8 As shown, it includes an upper protective cover 1, an upper shell 2, a lower shell 3, and a lower protective cover 5. All components are made of polylactic acid-glycolic acid copolymer (PLGA). This material begins to gradually disintegrate after 4 weeks of being inserted into the human body and completely disintegrates within 6 weeks. It is non-toxic, does not cause foreign body reactions, and the disintegration products can be naturally absorbed or excreted with the intestines.

[0054] The upper shell 2 and lower shell 3 are symmetrically structured, each containing multiple fixed magnet posts with a diameter of 5-6 mm and a height of 5-6 mm, used for positioning and fixing magnets 4. The shell surfaces each have multiple intestinal wall fixing pinholes 7 with a diameter of 1.5-2.0 mm, compatible with 3-0 absorbable sutures for easy suturing and fixation to the intestinal wall. After the two shells are joined, a through-hole drainage channel 12 is formed internally, with a diameter of 10-15 mm, ensuring normal drainage of intestinal contents. The edges of both the upper and lower shells are rounded to ensure relatively smooth stress during proximal and distal intestinal compression anastomosis, reducing the chance of anastomotic leakage. Additionally, the rounded edges facilitate the insertion of the anastomotic device into the intestinal lumen.

[0055] Both the upper shell 2 and the lower shell 3 are internally fitted with neodymium iron boron drum-shaped magnets 4, corresponding to the number of fixed magnet pillars. The magnets 4 have a diameter of 5-6 mm and a height of 5-6 mm. The surface magnetic force of a single magnet 4 is 4000-6000 Gauss, and the magnetic force at the intestinal contact surface is 1500-3500 Gauss. The magnets 4 are mounted on the fixed magnet pillars with alternating N and S poles. The N pole of the magnets 4 in the upper shell 2 faces the mating surface, and the corresponding S pole of the magnets 4 in the lower shell 3 faces the mating surface, ensuring a uniform and stable magnetic attraction. The surface of the magnets 4 is sequentially plated with a 0.005 mm thick titanium nitride corrosion-resistant layer and a 0.015 mm thick parylene insulating layer, effectively isolating them from intestinal secretions and preventing the formation of harmful substances.

[0056] The upper protective cover 1 and the upper shell 2, and the lower protective cover 5 and the lower shell 3 are all connected by a detachable fastening mechanism. The fastening point is provided with a sealing boss with a width of 0.5mm to enhance the sealing performance and prevent intestinal secretions and bacteria from contacting the magnet 4. The protective cover is 1mm thick and the edges are rounded to avoid damaging the intestinal wall during insertion.

[0057] Example 2: A method of using a disintegrating shell magnetic compression stapler suitable for rectal anastomosis, comprising the following steps:

[0058] S1: Component pre-installed.

[0059] The neodymium iron boron drum magnets 4, corresponding to the number of fixed magnet columns, are respectively installed on the fixed magnet columns of the upper shell 2 and the lower shell 3. It is strictly ensured that the magnets 4 are arranged in the correct direction, that is, the N pole of the magnets 4 in the upper shell 2 faces the mating surface, and the S pole of the corresponding magnets 4 in the lower shell 3 faces the mating surface. Then, the upper protective cover 1 is detachably fastened to the upper shell 2, and the lower protective cover 5 is detachably fastened to the lower shell 3. After fastening, the sealing performance of the sealing boss at the fastening point is checked to ensure that there is no looseness or gap, and to prevent subsequent intestinal secretions from contacting the magnets 4.

[0060] S2: Insertion and fixation of the proximal colon 13 component.

[0061] Under laparoscopic assistance, the pre-assembled upper protective cover 1 and upper shell 2 are slowly inserted into the predetermined anastomosis position of the proximal colon 13 of the patient. Through multiple intestinal wall fixation pinholes 7 on the surface of the upper shell 2, the upper shell 2 component is sutured and fixed to the intestinal wall of the proximal colon 13 using 3-0 absorbable sutures. During suturing, it is ensured that the sutures are firm and the component position is stable to avoid displacement of the component due to subsequent intestinal peristalsis.

[0062] S3: Distal rectal assembly processing and repositioning.

[0063] The distal anastomosis device is delivered to the distal end of the intestinal segment via a delivery device. Then, the pre-assembled lower protective cover 5 and lower housing 3 are sutured and fixed to the distal rectal wall through the intestinal wall fixation pinhole 7 on the surface of the lower housing 3 using 3-0 absorbable sutures to ensure that the intestinal segment is free from twisting and traction.

[0064] S4: Magnetic mating operation.

[0065] Using the magnetic attraction between the N and S poles of magnet 4, the upper shell 2 and the lower shell 3 are precisely aligned. After alignment, the two intestinal walls are continuously clamped to ensure stable clamping pressure (corresponding to a magnetic force of 1500~3500 Gauss at the intestinal contact surface of magnet 4), thus completing the anastomosis of the rectal tube.

[0066] S5: Postoperative observation and disintegration and excretion.

[0067] At 1, 2, 3, 4, 5 and 6 weeks postoperatively, abdominal X-rays or CT scans were performed to determine the extent of stapler dislodgement and to check for complications such as bleeding, leakage, and infection. During the anastomosis, intestinal contents were drained normally through the drainage channel 12 formed by the alignment of the upper shell 2 and the lower shell 3, avoiding obstruction. At 4 weeks postoperatively, the PLGA material shell began to gradually disintegrate and completely disintegrated within 6 weeks. The embedded magnet 4 pieces were naturally discharged from the body along with the intestinal contents, requiring no secondary surgery for removal, and leaving no residue in the body.

[0068] This embodiment utilizes a complete process: "insertion of the anastomosis device into the intestinal lumen (direct insertion at the proximal end, with the distal end temporarily fixed by a turned-out distal intestinal segment before insertion) → temporary suture fixation → automatic magnetic alignment → compression anastomosis → shell disintegration → natural discharge of magnet 4." This method optimizes the biomechanical alteration of the rectal anastomosis. It is simple to operate, has a short learning curve, provides reliable anastomosis, and leaves no foreign body residue. It significantly reduces the incidence of anastomotic leakage and the need for prophylactic stomas, demonstrating broad clinical application prospects.

[0069] Working principle: When using this anastomosis device, the magnet 4 is first pre-installed in the upper shell 2 and lower shell 3 of the disintegrating outer shell (PLGA material), and the protective cover is fastened to isolate the magnet 4 from the intestinal environment. The pre-installed upper shell 2 and lower shell 3 components are then placed into the proximal colon 13 and the distal rectum, respectively, and sutured and fixed through the pinholes of the shells to ensure stable positioning. After removing the protective cover, the neodymium iron boron drum-shaped magnets 4 (with alternating N and S poles) inside the upper shell 2 and lower shell 3 generate uniform magnetic attraction, driving the shells to precisely align and clamp the intestinal walls on both sides. During the clamping process, the internal drainage channel 12 ensures the normal discharge of intestinal contents, and the magnet 4 continuously provides stable clamping force to promote anastomotic healing. After the anastomosis heals (4-6 weeks), the disintegrating outer shell gradually degrades, and the magnet 4 is naturally discharged with intestinal feces, completing the entire anastomosis process.

[0070] Example 3: Test Experiment of a Disintegrating Shell Magnetic Compression Anastomosis Device Suitable for Rectal Anastomosis

[0071] This embodiment is used to test the burst pressure performance of a novel magnetic stapler and compare the burst pressure difference between the novel magnetic stapler and a medical stapler.

[0072] The experimental materials used in this embodiment are as follows:

[0073] Experimental sample: fresh pig intestine tissue;

[0074] Homemade stapler: magnetic stapler (as shown in Example 1);

[0075] Medical staplers: A commercially available brand of medical staplers (control group);

[0076] Water injection and pressurization system: water pump + pressure sensor.

[0077] The overall experimental results of this embodiment are summarized in Table 1:

[0078] Table 1. Overall Experiment Summary (Sorted by Time)

[0079] Among them, the magnetic stapler group consisted of 8 groups, with a range of 61.9–97.0 mmHg and a mean of 76.53 ± 12.58 mmHg; the medical stapler group consisted of 3 groups, with a range of 70.8–81.6 mmHg and a mean of 77.83 ± 6.09 mmHg. The statistical results, obtained using an unpaired samples t-test, are as follows: Figure 10 As shown.

[0080] In this embodiment, by comparing the burst pressure of the magnetic stapler and the medical stapler, there was no statistically significant difference in burst pressure between the magnetic compression stapler and the best stapler on the market (p=0.82).

[0081] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis, characterized in that: The device includes an upper protective cover (1), an upper shell (2), a lower shell (3), and a lower protective cover (5). Magnets (4) are embedded inside the upper shell (2) and the lower shell (3). The upper protective cover (1) is detachably fastened to the upper shell (2), and the lower protective cover (5) is detachably fastened to the lower shell (3). Both are used to isolate the magnets (4) from the intestinal environment. The upper shell (2) and the lower shell (3) are engaged by the magnetic attraction of the internal magnets (4), achieving magnetic compression anastomosis of the intestinal tract. The upper shell (2), the lower shell (3), the upper protective cover (1), and the lower protective cover (5) are all made of biodegradable polymer materials.

2. The disintegrating shell magnetic compression stapler for rectal anastomosis according to claim 1, characterized in that: The magnet (4) is a drum-shaped magnet (4), which is embedded inside the upper shell (2) and the lower shell (3) with the N pole and S pole arranged alternately.

3. The disintegrating shell magnetic compression stapler for rectal anastomosis according to claim 1, characterized in that: The magnet (4) is a neodymium iron boron magnet (4), and its surface is sequentially plated with a titanium nitride corrosion-resistant layer and a parylene insulating layer.

4. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to claim 1, characterized in that: The biodegradable polymeric material is polylactic-co-glycolic acid copolymer (PLGA). The anastomosis device shell gradually disintegrates after being inserted into the body for 4 weeks and completely disintegrates within 6 weeks.

5. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to claim 1, characterized in that: The upper shell (2) and the lower shell (3) are both equipped with fixed magnet columns inside, which are used to position and fix the magnet (4); the surfaces of the upper shell (2) and the lower shell (3) are both equipped with fixed intestinal wall pinholes (7), which are used to suture the stapler to the intestinal wall with absorbable sutures.

6. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to claim 5, characterized in that: The diameter of the fixed intestinal wall pinhole (7) is 1.5~2.0mm.

7. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to claim 1, characterized in that: After the upper shell (2) and the lower shell (3) are joined together, a through-hole drainage channel (12) is formed inside, through which intestinal contents pass.

8. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to claim 7, characterized in that: The diameter of the internal drainage channel (12) is 10~15mm.

9. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to claim 1, characterized in that: The surface magnetic force of a single magnet (4) is 4000~6000 Gauss, and the magnetic force at the contact surface with the intestine is 1500~3500 Gauss.

10. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to claim 9, characterized in that: The diameter of a single magnet (4) is 5~6 mm.

11. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to claim 10, characterized in that: The height of a single magnet (4) is 5~6mm.

12. A disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to claim 1, characterized in that: The upper protective cover (1) and the upper shell (2), and the lower protective cover (5) and the lower shell (3) are provided with sealing bosses at the fastening points to enhance the sealing performance and prevent intestinal secretions from contacting the magnet (4).

13. A method of using a disintegrating shell magnetic compression stapler suitable for rectal anastomosis according to any one of claims 1-12, characterized in that: Includes the following steps: S1. Component pre-assembly: Install the magnet (4) into the fixed magnet column of the upper shell (2) and the lower shell (3) respectively, fasten the upper protective cover (1) to the upper shell (2), fasten the lower protective cover (5) to the lower shell (3), and check the sealing performance; S2, Proximal insertion: The pre-assembled upper protective cover (1) and upper shell (2) assembly is inserted into the proximal colon (13), and the assembly is sutured to the intestinal wall with absorbable sutures through the fixation intestinal wall pinholes (7); S3, distal processing: After turning the distal intestinal tube out, the intestinal wall and the lower shell (3) assembly are sutured and fixed to the distal intestinal wall through the fixed intestinal wall pinhole (7). The lower shell (3) assembly is turned into the intestine, and the distal anastomosing device is sent into the intestinal lumen through the delivery device to ensure that the intestinal tube is not twisted. S4. Magnetic anastomosis: The upper shell (2) and the lower shell (3) automatically align under the action of magnetic force, clamping the intestinal walls on both sides and maintaining stable alignment pressure; S5. Postoperative observation and disintegration discharge: After the operation, the implantation of the stapler in the body is observed regularly by X-ray or CT. The outer shell material gradually disintegrates in the body, and the magnet (4) is discharged naturally in pieces with the intestinal contents. There is no metal residue in the body.

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