Method for preparing biodegradable magnesium metal hernia repair patch and patch implantation system

By using a biodegradable hernia repair patch made of magnesium alloy and a dedicated implantation system, the problems of existing hernia repair patches easily shrinking, adhering, and deforming in the human body have been solved. This has achieved the absorbability and biocompatibility of magnesium metal hernia repair patches, ensuring the stability and safety of the surgery.

CN116728011BActive Publication Date: 2026-01-30SUZHOU ORIGIN MEDICAL TECH
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Patent Information

Application Number
CN202310702685.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-06-14
Publication Date
2026-01-30
Estimated Expiration
2043-06-14

AI Technical Summary

Technical Problem

Existing hernia repair patch materials are prone to shrinkage, adhesion, and deformation in the human body, resulting in poor surgical outcomes. Furthermore, biological patches require stringent storage conditions, are prone to deterioration, and are susceptible to contamination during implantation into the abdominal cavity, necessitating optimization.

Method used

The biodegradable hernia patch, made of magnesium alloy, is produced by extrusion rolling and annealing into a magnesium plate of a set size. It is then cut into a mesh and an outer contour, with the outer contour designed as a wavy edge or rounded corner. It is then implanted in conjunction with a dedicated patch implantation system, which includes an outer tube, an inner rod, and a pusher to ensure the stability and biocompatibility of the patch.

Benefits of technology

The magnesium metal hernia repair patch is absorbable, avoiding wound infection and foreign body reaction. The outer contour design reduces damage to peritoneal tissue, and the patch implantation system is easy to operate, ensuring the stability and safety of the surgery.

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Abstract

This invention discloses a method for preparing a biodegradable magnesium metal hernia repair patch and a patch implantation system, belonging to the field of patch technology. The method for preparing the biodegradable magnesium metal hernia repair patch includes: using a magnesium plate as the base material, with a mesh size of 0-70%, and the outer contour of the patch having wavy edges or rounded corners; the thickness of the biodegradable magnesium metal hernia repair patch being 0.05mm to 0.5mm; selecting a magnesium alloy ingot as the base material, and extruding and rolling the base material into an ingot plate of a predetermined size; annealing the ingot plate in an annealing furnace at 180°C for 1-2 hours, removing it, and leveling it to form a magnesium plate; processing the mesh and outer contour on the magnesium plate using cutting or stamping equipment to form a prototype patch; polishing, cleaning, packaging, and sterilizing the prototype patch to obtain the biodegradable magnesium metal hernia repair patch, which is not only absorbable by the human body but also has low plasticity and hardness, making it easy to store and implant in the body.
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Description

Technical Field

[0001] This invention relates to the field of patch technology, and in particular to a method for preparing a biodegradable magnesium metal hernia repair patch and a patch implantation system. Background Technology

[0002] Hernia repair patches are a general term for hernia repair materials. In recent years, with the rapid development of materials science, various hernia repair materials have been widely used in clinical practice, fundamentally changing the treatment of hernias. Hernia repair patches are mainly used to repair abdominal wall hernias, which refer to the bulging of organs or tissues within the abdominal cavity through weak areas or defects in the abdominal wall. Abdominal wall hernias include inguinal hernias, umbilical hernias, femoral hernias, incisional hernias, and parastomal hernias, with inguinal hernias (located at the junction of the thigh and abdomen) being the most common. Due to their high incidence, the treatment of abdominal wall hernias has become an important social issue.

[0003] Currently, hernia repair surgery is the only option for curing abdominal wall hernias. Hernia repair patch materials are divided into two main categories: one is artificial polymer patch, based on polymers, using polymers such as polypropylene, polyester, and polytetrafluoroethylene; the other is biological patch, based on natural biological materials. Materials approved by the U.S. Food and Drug Administration (FDA) for clinical use include human dermis, the submucosa of the small intestine of pigs, pig dermis, and embryonic bovine dermis.

[0004] Currently, most absorbable hernia repair patches on the market are made of biological patches, using bovine pericardial tissue, porcine small intestinal submucosa, or other animal tissues. A few are made of polymeric materials, such as glycolic acid and polylactic acid-glycolic acid. After surgery, the absorption of biological patches generates heat, which may cause rejection or fever in patients. Furthermore, the hernia repair patch is prone to shrinkage and deformation after implantation, affecting the surgical outcome.

[0005] Because non-absorbable materials tend to shrink in the human body, causing inflammatory reactions and persistent foreign body sensation, sometimes requiring a second surgery for removal, absorbable materials have a promising future. However, current absorbable material patches still suffer from problems such as postoperative shrinkage, adhesion, deformation, inability to adhere to the abdominal wall, or ineffectiveness. Furthermore, biological patches require stringent storage conditions, are prone to deterioration, and are easily contaminated during implantation into the abdominal cavity, necessitating further optimization.

[0006] Therefore, there is an urgent need to provide a method for preparing a biodegradable magnesium metal hernia repair patch and a patch implantation system to solve the above problems. Summary of the Invention

[0007] The purpose of this invention is to provide a method for preparing a biodegradable magnesium metal hernia repair patch and a patch implantation system. The biodegradable magnesium metal hernia repair patch can not only be absorbed by the human body, but also has low plasticity and hardness, making it easy to store and implant in the body.

[0008] To achieve the above objectives, the following technical solution is provided:

[0009] A method for preparing a biodegradable magnesium metal hernia repair patch includes the following steps: the biodegradable magnesium metal hernia repair patch is made of magnesium plate, the mesh ratio of the patch is 0-70%, the outer contour of the patch is provided with wavy edges or rounded corners, and the thickness of the biodegradable magnesium metal hernia repair patch is 0.05mm to 0.5mm.

[0010] Magnesium alloy ingots are selected as the base material, with a magnesium content greater than 97.75%, a zinc content less than 2.25%, and a total content of silicon, copper, iron, nickel, titanium, aluminum, and manganese less than 0.3%. The base material is extruded and rolled into ingot plates of a set size. The ingot plates are annealed in an annealing furnace at 180°C for 1-2 hours, then removed and leveled to form the magnesium plate. The mesh and outer contour are machined into the magnesium plate using cutting or stamping equipment to form a prototype patch. The prototype patch is polished, cleaned, packaged, and sterilized to obtain the biodegradable magnesium metal hernia repair patch.

[0011] As an alternative method for preparing a biodegradable magnesium metal hernia patch, when a laser cutting machine is used as the cutting equipment, the magnesium plate is clamped in the fixed position of the laser cutting machine, the mesh is cut out first, and then the outer contour is cut out to obtain the prototype patch.

[0012] As an alternative to the method for preparing biodegradable magnesium metal hernia repair patches, the processing environment during laser cutting is a nitrogen or argon protective environment with a pressure of 0.2 MPa to 1 MPa.

[0013] As an alternative method for preparing biodegradable magnesium metal hernia repair patches, the anisotropy of the billet plate is eliminated by performing multiple rolling processes along the vertical and horizontal directions during the extrusion rolling process.

[0014] A patch implantation system for implanting a biodegradable magnesium hernia patch prepared by the method described in any of the preceding claims into the body, the patch implantation system comprising:

[0015] An outer tube fitting includes a connected protective tube and a handle. The protective tube has a communicating front cavity and a guide cavity. The side wall of the guide cavity has a sliding groove. The first inner wall surface and the second inner wall surface of the guide cavity are set at an angle. The handle has a receiving cavity.

[0016] An inner rod is slidably disposed inside the outer tube. The inner rod includes a connected guide rod and a rear connecting rod. The guide rod is disposed at an angle to the first outer wall surface and the second outer wall surface. The first outer wall surface can slide along the first inner wall surface. A clamping space is formed between the second inner wall surface and the second outer wall surface.

[0017] A pusher is slidably disposed on the grip, and one end of the pusher is connected to the rear connecting rod located in the accommodating cavity.

[0018] As an optional solution for the patch implantation system, the protective tube is provided with an air hole, which is connected to the anterior cavity.

[0019] As an optional solution for the patch implantation system, the outer tube is provided with a horn groove, which is connected to the sliding groove, and the width of the horn groove gradually increases in the direction away from the protective tube.

[0020] As an optional solution for the patch implantation system, a first conical transition surface is provided at the connection transition between the protective tube and the handle, and a second conical transition surface is provided at the connection transition between the guide rod and the rear connecting rod.

[0021] As an alternative to the patch implantation system, the guide cavity is misaligned with the central axis of the protective tube.

[0022] As an optional solution for the patch implantation system, the grip is provided with an open groove, the coronal block of the pusher is slidably disposed on the grip, the guide block of the pusher passes through the open groove, the fastener passes through the outer hole and through hole of the pusher and is threadedly connected to the screw hole of the rear connecting rod, and the outer wall surface of the grip is provided with anti-slip texture.

[0023] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0024] The present invention provides a method for preparing a biodegradable magnesium metal hernia repair patch and an absorbable metal hernia repair patch. The patch is made of magnesium plate. The magnesium metal can be absorbed by the human body and will not cause complications such as wound infection or foreign body reaction after long-term implantation. The outer contour of the patch is provided with wavy edges or rounded corners to eliminate the damage of sharp angles to peritoneal tissue. It is divided into several models according to its outer contour size. Magnesium alloy ingots are selected as the base material, with a magnesium content greater than 97.75%, a zinc content less than 2.25%, and a total content of silicon, copper, iron, nickel, titanium, aluminum, and manganese less than 0.3%. The base material is extruded and rolled into ingot plates of a set size. The ingot plates are annealed in an annealing furnace at 180°C for 1-2 hours, then removed and leveled to form magnesium plates. Mesh and outer contours are machined into the magnesium plates using cutting or stamping equipment to form a prototype hernia repair patch. The prototype hernia repair patch is polished, cleaned, packaged, and sterilized to obtain an absorbable metal hernia repair patch. The thickness of the biodegradable magnesium metal hernia repair patch is 0.05mm to 0.5mm, resulting in low plasticity and hardness, stable degradation, and good biocompatibility.

[0025] The patch implantation system provided by this invention includes an inner rod inside an outer tube. One end of a biodegradable magnesium hernia patch is inserted into a guide cavity through a sliding slot. One end of a pusher is connected to a rear connecting rod located in the receiving cavity. The pusher can drive the inner rod to slide back and forth within the outer tube. The first and second outer wall surfaces of the guide rod are set at an angle to each other, and the first and second inner wall surfaces of the guide cavity are also set at an angle to each other. When the first outer wall surface slides forward along the first inner wall surface, the clamping space formed between the second inner wall surface and the second outer wall surface is reduced to clamp the biodegradable magnesium hernia patch. When the first outer wall surface slides backward along the first inner wall surface, the clamping space formed between the second inner wall surface and the second outer wall surface is increased to release the biodegradable magnesium hernia patch. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of the present invention and these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the patch implantation system assembly in an embodiment of the present invention;

[0028] Figure 2 This is an exploded view of the patch implantation system in an embodiment of the present invention;

[0029] Figure 3This is a schematic diagram of the structure of the pusher in an embodiment of the present invention;

[0030] Figure 4 This is a structural schematic diagram of the outer tube fitting from a first-view perspective in an embodiment of the present invention;

[0031] Figure 5 This is a structural schematic diagram of the outer tube fitting from a second perspective in an embodiment of the present invention;

[0032] Figure 6 for Figure 5 A magnified view of a section at point A in the middle;

[0033] Figure 7 This is a structural schematic diagram of the outer tube fitting from a third-view perspective in an embodiment of the present invention;

[0034] Figure 8 This is a cross-sectional view of the outer pipe fitting in an embodiment of the present invention;

[0035] Figure 9 This is a structural schematic diagram of the inner rod from a first-view perspective in an embodiment of the present invention;

[0036] Figure 10 for Figure 9 A magnified view of a section at point B in the middle;

[0037] Figure 11 This is a structural schematic diagram of the inner rod from a second perspective in an embodiment of the present invention;

[0038] Figure 12 This is a partial sectional view of the inner rod inside the outer tube in an embodiment of the present invention;

[0039] Figure 13 This is a schematic diagram of the structure of the first biodegradable magnesium metal hernia repair patch in an embodiment of the present invention;

[0040] Figure 14 This is a schematic diagram of the structure of the second biodegradable magnesium metal hernia repair patch in an embodiment of the present invention;

[0041] Figure 15 This is a schematic diagram of the structure of the third biodegradable magnesium metal hernia repair patch in an embodiment of the present invention;

[0042] Figure 16 This is a schematic diagram of the structure of the fourth biodegradable magnesium metal hernia repair patch in the embodiments of the present invention;

[0043] Figure 17 This is a schematic diagram of the structure of the fifth biodegradable magnesium metal hernia repair patch in the embodiments of the present invention;

[0044] Figure 18 This is a schematic diagram of the sixth biodegradable magnesium metal hernia repair patch in the embodiments of the present invention;

[0045] Figure 19 This is a schematic diagram of the structure of the seventh biodegradable magnesium metal hernia repair patch in the embodiments of the present invention;

[0046] Figure 20 This is a schematic diagram of the structure of the eighth biodegradable magnesium metal hernia repair patch in the embodiments of the present invention.

[0047] Figure label:

[0048] 100. Biodegradable magnesium metal hernia repair patch; 101. Mesh; 102. Outer contour;

[0049] 1. Outer tubular fittings; 2. Inner rods; 3. Pushing components; 4. Clamping space;

[0050] 11. Protective tube; 111. Thick wall; 112. Thin wall; 113. Surrounding area; 12. Grip; 121. Opening groove; 122. Anti-slip texture; 13. Front cavity; 14. Guide cavity; 141. First inner wall surface; 142. Second inner wall surface; 15. Sliding groove; 16. Receiving cavity; 17. Air hole; 18. Horn groove; 19. First conical transition surface;

[0051] 21. Guide rod; 211. First outer wall surface; 212. Second outer wall surface; 22. Rear connecting rod; 221. Screw hole; 23. Second tapered transition surface;

[0052] 31. Coronal block; 32. Guide block; 33. External hole; 34. Through hole. Detailed Implementation

[0053] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0054] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0055] 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.

[0056] In the description of this invention, it should be noted that the terms "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this invention is in use. They are used only for the convenience of describing the invention 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 the invention. Furthermore, the terms "first," "second," and "third," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0057] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set" and "connection" 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. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0058] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0059] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0060] To ensure that biodegradable magnesium hernia repair patches are not only absorbable by the human body but also have low plasticity and hardness, facilitating their placement and implantation, this embodiment provides a method for preparing a biodegradable magnesium hernia repair patch and a patch implantation system. The following describes the process in conjunction with... Figures 1 to 20 The specific content of this embodiment is described in detail below. In this embodiment, the method for preparing a biodegradable magnesium metal hernia repair patch includes the following steps:

[0061] The biodegradable magnesium metal hernia repair patch 100 is made of magnesium plate. The mesh 101 of the biodegradable magnesium metal hernia repair patch 100 accounts for 0-70%, and the mesh 101 is polygonal or circular in shape, arranged with equal rib widths, and the rib width is greater than 0.8 mm. The outer contour 102 of the biodegradable magnesium metal hernia repair patch 100 is provided with wavy edges or rounded corners. The thickness of the biodegradable magnesium metal hernia repair patch 100 is 0.05 mm to 0.5 mm. Magnesium alloy ingots are selected as the base material. The magnesium content of the magnesium alloy ingots is greater than 97.75%, the zinc content is less than 2.25%, and the total content of silicon, copper, iron, nickel, titanium, aluminum and manganese is less than 0.3%. The base material is extruded and rolled into ingot plates of a set size.

[0062] The billet is annealed in an annealing furnace at 180°C for 1-2 hours, then removed and leveled to form a magnesium plate.

[0063] A preliminary patch is made by machining mesh 101 and outer contour 102 on a magnesium plate using cutting or stamping equipment;

[0064] After polishing, cleaning, packaging and sterilization of the prototype patch, a biodegradable magnesium metal hernia repair patch 100 is obtained.

[0065] In summary, the biodegradable magnesium metal hernia repair patch preparation method provided by this invention uses a magnesium plate to make the patch. The magnesium metal can be absorbed by the human body, and long-term implantation will not cause complications such as wound infection or foreign body reaction. The outer contour 102 of the patch is provided with wavy edges or rounded corners to eliminate sharp corners and avoid scratching tissue. Several models are available based on the size of its outer contour 102. Magnesium alloy ingots are selected as the base material. The magnesium content of the ingots is greater than 97.75%, the zinc content is less than 2.25%, and the total content of silicon, copper, iron, nickel, titanium, aluminum, and manganese is less than 0.3%. The base material is extruded and rolled into ingot plates of a set size. The ingot plates are annealed in an annealing furnace at 180°C for 1-2 hours, then removed and leveled to form magnesium plates. Mesh 101 and outer contour 102 are processed on the magnesium plates using cutting or stamping equipment to form a prototype hernia repair patch. The prototype hernia repair patch is polished, cleaned, packaged, and sterilized to obtain an absorbable metal hernia repair patch. The thickness of the biodegradable magnesium metal hernia repair patch 100 is 0.05mm to 0.5mm, which results in low plasticity and hardness of the patch, leading to stable degradation and good biocompatibility.

[0066] Furthermore, when a laser cutting machine is used as the cutting equipment, the magnesium plate is clamped in the fixed position of the laser cutting machine, and the mesh 101 is cut out first, followed by the outer contour 102 to obtain the prototype patch. Preferably, when the laser cutting machine is used, the processing environment is a nitrogen or argon protective environment with a pressure of 0.2 MPa to 1 MPa.

[0067] Furthermore, in the extrusion rolling process, the anisotropy of the billet is eliminated by performing multiple rolling operations along the vertical and horizontal directions. For example, the billet has a length of 140±1 mm and a width of 140±1 mm.

[0068] Metal materials are relatively hard, unlike soft biological patches. Metal patches are difficult to directly enter the abdominal cavity during laparoscopic surgery. Magnesium alloys have moderate hardness and yield strength. The biodegradable magnesium metal hernia repair patch 100 prepared by the above molding process has no obvious elasticity and is easy to curl. In order to deliver the patch into the human abdominal cavity for surgery, a corresponding matching instrument was invented for implantation of biodegradable magnesium metal hernia repair patch 100.

[0069] This embodiment also provides a patch implantation system for implanting a biodegradable magnesium metal hernia repair patch 100, prepared by the aforementioned biodegradable magnesium metal hernia repair patch preparation method, into the body. The patch implantation system includes an outer tube 1, an inner rod 2, and a pusher 3. The outer tube 1 includes a connected protective tube 11 and a handle 12. The protective tube 11 has a communicating front cavity 13 and a guide cavity 14. The side wall of the guide cavity 14 has a sliding groove 15. The first inner wall surface 141 and the second inner wall surface 142 of the guide cavity 14 are set at an angle. The handle 12 has a receiving cavity 16. The inner rod 2 is slidably disposed in the outer tube 1. The inner rod 2 includes a connected guide rod 21 and a rear connecting rod 22. The first outer wall surface 211 and the second outer wall surface 212 of the guide rod 21 are set at an angle. The first outer wall surface 211 can slide along the first inner wall surface 141. A clamping space 4 is formed between the second inner wall surface 142 and the second outer wall surface 212. The pusher 3 is slidably disposed on the grip 12, and one end of the pusher 3 is connected to the rear connecting rod 22 located in the accommodating cavity 16.

[0070] The patch implantation system provided by this invention includes an inner rod 2 inside an outer tube 1. One end of a biodegradable magnesium metal hernia repair patch 100 is inserted into a guide cavity 14 through a sliding slot 15. One end of a pusher 3 is connected to a rear connecting rod 22 located in a receiving cavity 16. The pusher 3 can drive the inner rod 2 to slide back and forth within the outer tube 1. The guide rod 21 has a first outer wall surface 211 and a second outer wall surface 212 facing each other at an angle. The guide cavity 14 has a first inner wall surface 141 facing the second outer wall surface 212. The two inner wall surfaces 142 are set at an angle. When the first outer wall surface 211 slides forward along the first inner wall surface 141, the clamping space 4 formed between the second inner wall surface 142 and the second outer wall surface 212 is reduced, which is used to clamp the biodegradable magnesium metal hernia repair patch 100. When the first outer wall surface 211 slides backward along the first inner wall surface 141, the clamping space 4 formed between the second inner wall surface 142 and the second outer wall surface 212 is increased, which is used to release the biodegradable magnesium metal hernia repair patch 100.

[0071] Furthermore, the grip 12 is provided with an open slide groove 121, the crown block 31 of the pusher 3 is slidably disposed on the grip 12, the guide block 32 of the pusher 3 passes through the open slide groove 121, and the fastener passes through the outer hole 33 and the through hole 34 of the pusher 3 and is threadedly connected to the screw hole 221 of the rear connecting rod 22.

[0072] Furthermore, the protective tube 11 is provided with an air hole 17, which is connected to the front cavity 13. The length of the guide rod 21 is greater than the length of the sliding groove 15. When the guide rod 21 moves forward, the head of the guide rod 21 can enter the front cavity 13. By adding the air hole 17, it is convenient for the guide rod 21 to be smoothly inserted into the front cavity 13.

[0073] Furthermore, the outer tube 1 is provided with a flared groove 18, which communicates with the sliding groove, and the width of the flared groove 18 gradually increases in the direction away from the protective tube 11. By adding the flared groove 18, the biodegradable magnesium metal hernia repair patch 100 can easily enter the sliding groove after passing through the flared groove 18.

[0074] Furthermore, in this embodiment, the guide cavity 14 is misaligned with the central axis of the protective tube 11. Since the guide cavity 14 does not pass through the central axis of the protective tube 11, the outer wall of the protective tube 11 is made thinner and thicker, allowing the biodegradable magnesium metal hernia repair sheet 100 to be wound along the thick wall 111 direction without damaging the biodegradable magnesium metal hernia repair sheet 100. The outer wall surface of the handle 12 is provided with anti-slip texture 122 to increase the friction between the hand and the outer tube 1.

[0075] Furthermore, a first conical transition surface 19 is provided at the connection transition between the protective tube 11 and the grip 12, and a second conical transition surface 23 is provided at the connection transition between the guide rod 21 and the rear connecting rod 22. By providing the first conical transition surface 19, stress concentration at the connection transition between the protective tube 11 and the grip 12 is avoided; by providing the second conical transition surface 23, stress concentration at the connection transition between the guide rod 21 and the rear connecting rod 22 is avoided.

[0076] Specifically, the first inner wall surface 141 and the second inner wall surface 142 are at a certain angle, and the first outer wall surface 211 and the second outer wall surface 212 are at the same angle. The guide block 32 of the pusher 3 slides in conjunction with the open slide groove 121, and the through hole 34 and the screw hole 221 are fixed by screws. During operation, the thumb applies force to push the crown block 31, causing the pusher 3 to slide back and forth along the open slide groove 121. Through the fixed connection between the through hole 34 and the screw hole 221, the pushing force is transmitted to the rear connecting rod 22. The rear connecting rod 22 and the guide rod 21 are connected by a second conical transition surface 23. The second conical transition surface 23 can improve the connection between the guide rod 21 and the rear connecting rod 22 and prevent the guide rod 21 from breaking brittlely. During operation, the guide cavity 14 and the guide rod 21 cooperate with each other, allowing the inner rod 2 to slide back and forth within the outer tube 1. The first inner wall surface 141 and the first outer wall surface 211 move relative to each other, and the distance (clamping space 4) between the second inner wall surface 142 and the second outer wall surface 212 changes relative to each other. Specifically, when the pusher 3 slides forward, the distance (clamping space 4) between the second inner wall surface 142 and the second outer wall surface 212 decreases; when the pusher 3 slides backward, the distance (clamping space 4) between the second inner wall surface 142 and the second outer wall surface 212 increases. The biodegradable magnesium metal hernia repair piece 100 is placed in the sliding groove 15. During operation, the movement of the pusher 3 can clamp or release the biodegradable magnesium metal hernia repair piece 100. Since the sliding groove 15 is relatively narrow, it is inconvenient to place the biodegradable magnesium metal hernia repair piece 100. Therefore, a flared groove 18 is provided at the first conical transition surface 19 to facilitate the placement of the biodegradable magnesium metal hernia repair piece 100. The biodegradable magnesium hernia repair patch 100 is inserted into the horn groove 18, and the patch is slid forward along the sliding groove 15 by hand until it is fully inserted. Then, a forward force is applied to the pusher 3 to clamp the patch 100. The front end of the guide cavity 14 is connected to the front cavity 13. When clamping the patch 100, the front end of the guide rod 21 extends into the front cavity 13, and the internal gas is discharged through the vent 17. During winding, the patch 100 is fixed within the clamping space 4. Winding the patch 100 along the thick wall 111 of the protective tube 11 will not damage the patch. After clamping, hold the biodegradable magnesium hernia repair patch 100 with one hand while rotating the handle 12 with the other hand. The hand contacts the anti-slip texture 122 to increase friction. The rotational force is transmitted to the surrounding area 113 through the first conical transition surface 19. Continuously rotating the handle 12 completes the wrapping of the patch. After wrapping, due to the moderate yield strength of the biodegradable magnesium hernia repair patch 100, it will wrap around the surrounding area 113 without rebounding. It can then be smoothly entered into the abdominal cavity with the accompanying instruments and laparoscopic surgical channel to complete the hernia surgery.

[0077] In some applications, the substrate is a magnesium alloy ingot of grade Mg9998. This ingot is extruded to reduce its thickness, and then rolled multiple times in both the vertical and horizontal directions to eliminate anisotropy. After milling, it is made into a thin sheet with dimensions of 150mm × 120mm × 0.25mm. This sheet is then annealed in an annealing furnace at 180℃ for 1-2 hours. The flattened magnesium sheet is then used as the substrate. This magnesium sheet is clamped in a fixed position on a laser cutting machine. The processing environment is a nitrogen or argon atmosphere with a pressure of 0.2Mpa. Because the magnesium sheet is only 0.25mm thick and easily deformed, a specific clamp is required. The power, frequency, pulse width, and linear speed parameters of the laser cutting machine are adjusted. First, the mesh 101 is cut out. Multiple cuts are made to complete the multi-hole processing. Then, the outer contour 102 of the patch is cut out. After falling off, a preliminary hernia repair patch is obtained. Following the steps above, a prototype hernia repair patch with one smooth side and one rough side is obtained. It is then polished in a polishing solution until both sides are shiny and burr-free. After cleaning and packaging, a biodegradable magnesium metal hernia repair patch 100 is prepared.

[0078] Optionally, the prepared biodegradable magnesium metal hernia repair patch 100 has a thickness of 0.18 mm and an external dimension of 100 mm × 100 mm. Push the pusher 3 to its rearmost position, so that the second inner wall surface 142 and the second outer wall surface 212 are far apart. Insert the biodegradable magnesium metal hernia repair patch 100 into the horn groove 18. Squeeze the patch by hand and slide it along the sliding groove 15 towards the front end until it is fully inserted into the sliding groove 15. Then push the coronal block 31 forward to clamp the patch. Gently pinch the biodegradable magnesium metal hernia repair patch 100 with your left hand and hold the handle 12 with your right hand, simultaneously rotating the handle 12 counterclockwise. This will cause the patch to wrap around the surrounding area 113 of this matching instrument along the thick wall direction 111. The surrounding area 113 of the surrounding instrument after the patch is in this embodiment has an overall outer diameter of 7-8mm, less than 10mm. During laparoscopic surgery, it can be inserted into the abdominal cavity through a 10mm or larger trocar channel. The patch can be unfolded by grasping the edge of the patch and rotating the handle 12 in the opposite direction. After the patch is unfolded, the coronal block 31 can be pushed backward to release the patch, so as to cooperate with the doctor to complete the hernia surgery.

[0079] In this embodiment, besides laser cutting, the mesh 101 can be processed by precision punching, using a specific set of tools. For example... Figures 13 to 20 As shown, the biodegradable magnesium metal hernia repair patch 100 is divided into several models and specifications according to the size of its outer contour 102 and the arrangement of its mesh 101. Among them, such as... Figure 13 As shown, the outer contour 102 is square, the mesh 101 is square, and a wavy edge is provided around the outer contour 102; as Figure 14 As shown, the outer contour 102 is square, the mesh 101 is square, and multiple continuous rounded corners are provided around the outer contour 102; as Figure 15 As shown, the outer contour 102 is circular, and the mesh 101 is a regular hexagon; as Figure 16 As shown, the outer contour 102 is square, the mesh 101 is triangular, and a wavy edge with sharp angles is provided around the outer contour 102; as shown Figure 17 As shown, the outer contour 102 is circular, and the mesh 101 includes regular hexagons, triangles, and parallelograms; as Figure 18 As shown, the outer contour 102 is square, the mesh 101 is circular, and multiple continuous rounded corners and wavy edges are provided around the outer contour 102; as Figure 19 As shown, the outer contour 102 is irregular in shape, and the mesh 101 is triangular; as Figure 20 As shown, the outer contour 102 is petal-shaped, and the mesh 101 includes triangles and squares.

[0080] Note that the above description is merely a preferred embodiment of the present invention and the technical principles employed. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and various obvious changes, readjustments, and substitutions can be made without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in detail through the above embodiments, the present invention is not limited to the above embodiments, and may include many other equivalent embodiments without departing from the concept of the present invention, the scope of which is determined by the scope of the appended claims.

Claims

1. A patch implant system characterized by, The patch implant system is used for implanting a degradable magnesium metal hernia patch (100) into the body, the degradable magnesium metal hernia patch (100) is prepared by a degradable magnesium metal hernia patch preparation method, and the degradable magnesium metal hernia patch preparation method comprises the following steps: The degradable magnesium metal hernia patch (100) is made of a magnesium plate, the mesh hole (101) of the degradable magnesium metal hernia patch (100) accounts for 0-70%, the outer contour (102) of the degradable magnesium metal hernia patch (100) is provided with a wavy edge or a round corner, and the thickness of the degradable magnesium metal hernia patch (100) is 0.05mm to 0.5mm; The magnesium alloy billet is selected as the base material, the magnesium content of the magnesium alloy billet is greater than 97.75%, the zinc content is less than 2.25%, and the total content of silicon, copper, iron, nickel, titanium, aluminum and manganese is less than 0.3%; the base material is extruded into a billet plate with a set size; the billet plate is annealed in an annealing furnace at a temperature of 180 DEG C for 1h-2h, taken out and flattened to form the magnesium plate; The mesh hole (101) and the outer contour (102) are machined on the magnesium plate to form a rough patch by using cutting equipment or stamping equipment; The rough patch is polished, washed, packaged and sterilized to obtain the degradable magnesium metal hernia patch (100); The patch implant system comprises: An outer tube (1) comprising a protective tube (11) and a handle (12) connected thereto, a front cavity (13) and a guide cavity (14) being communicated in the protective tube (11), a sliding slot (15) being formed in the side wall of the guide cavity (14), and a first inner wall surface (141) and a second inner wall surface (142) of the guide cavity (14) being arranged at an angle; An inner rod (2) being slidably arranged in the outer tube (1), the inner rod (2) comprising a guide rod (21) and a rear connecting rod (22) connected thereto, a first outer wall surface (211) and a second outer wall surface (212) of the guide rod (21) being arranged at an angle, the first outer wall surface (211) being capable of sliding along the first inner wall surface (141), and a clamping space (4) being formed between the second inner wall surface (142) and the second outer wall surface (212); A pushing member (3) being slidably arranged on the handle (12), and one end of the pushing member (3) being connected with the rear connecting rod (22) arranged in the accommodating cavity (16).

2. The patch implant system of claim 1, wherein, When the cutting equipment is a laser cutting machine, the magnesium plate is clamped in the fixed station of the laser cutting machine, the mesh hole (101) is cut first, and then the outer contour (102) is cut to obtain the rough patch.

3. The patch implant system of claim 2, wherein, When the laser cutting machine is cutting, the processing environment is a nitrogen or argon protection environment with a pressure of 0.2Mpa to 1Mpa.

4. The patch implant system of claim 2, wherein, In the extrusion process, the anisotropy of the billet plate is eliminated by multiple rolling in the vertical and horizontal directions.

5. The patch implant system of claim 1, wherein, The protection pipe (11) is provided with an air hole (17) which communicates with the front cavity (13).

6. The patch implant system of claim 1, wherein, The outer pipe (1) is provided with a horn slot (18) which communicates with the sliding slot (15) and the width of the slot of the horn slot (18) gradually increases in the direction away from the protection pipe (11).

7. The patch implant system of claim 6, wherein, The connection transition of the protection pipe (11) and the handle (12) is provided with a first taper transition surface (19) and the connection transition of the guide rod (21) and the rear connecting rod (22) is provided with a second taper transition surface (23).

8. The patch implant system of claim 1, wherein, The guide cavity (14) is dislocated with the central axis of the protection pipe (11).

9. The patch implant system of claim 1, wherein, The handle (12) is provided with an open sliding slot (121), the crown-shaped block (31) of the pusher (3) is slidingly arranged on the handle (12), the guide block (32) of the pusher (3) is arranged in the open sliding slot (121), a fastener is threadedly connected with the screw hole (221) of the rear connecting rod (22) through the outer hole (33) and the through hole (34) of the pusher (3), and the outer wall surface of the handle (12) is provided with an anti-skid pattern (122).

Citation Information

Patent Citations

  • Preparation method of biodegradable medical magnesium metal and magnesium alloy patch

    CN114177349A