Laparoscope hernia repair patch free of free hernial sac

Abstract

The invention relates to the technical field of surgical instruments, and discloses a free hernial sac-free laparoscopic hernia repair patch which comprises an anti-adhesion area with a conical structure in the center and a peripheral polypropylene area, and the surface of the conical structure is provided with clockwise spiral guide lines; an intelligent protection area is arranged on the inner side, close to the end part, of the conical structure, adopts a biological functional three-layer composite structure, and comprises an anti-infection layer made of a polycaprolactone membrane material, a buffer layer interwoven by elastic fibers to form a honeycomb network, and a tissue interface layer made of a modified chitosan material. By means of the innovative progressive conical structure and the spiral guide line design, the simplified operation process without dissociating the hernial sac is achieved; the composite structure design of the anti-adhesion area and the peripheral polypropylene area ensures the stability of the patch; the intelligent protection system can trigger release of silver ions through physiological activities of the human body, a continuous dynamic antibacterial barrier is formed, and more comprehensive implantation safety guarantee is provided for herniorrhaphy.

Description

Technical Field

[0001] The present invention relates to the technical field of surgical instruments, and particularly relates to an adhesion-preventing patch for laparoscopic transabdominal inguinal hernia repair without dissecting the hernia sac. The present invention also relates to the application of the patch in laparoscopic inguinal hernia repair. Background Art

[0002] Inguinal hernia is a common surgical disease. With the development of minimally invasive techniques, laparoscopic surgery has become the main method for treating inguinal hernia due to its advantages such as small trauma and rapid recovery. Currently, two main surgical procedures are mainly used clinically: laparoscopic transabdominal preperitoneal repair (TAPP) and laparoscopic totally extraperitoneal repair (TEP). Among them, TAPP is more widely used in clinical practice due to advantages such as a large surgical space and a short learning curve.

[0003] However, the traditional TAPP surgery has the following problems: First, it is necessary to arc-incise the peritoneum 3 cm above the upper edge of the hernia defect, and the dissection range is extensive, including the preperitoneal space from the pubic symphysis internally, the psoas major and anterior superior iliac spine externally, 3 cm above the conjoint tendon superiorly, and 3 cm below the pectineal ligament inferiorly and internally. Second, it is necessary to dissect the hernia sac from the spermatic cord and fully dissect it from the posterior spermatic cord vessels and vas deferens for 6 - 8 cm to achieve "abdominal wall formation" of the spermatic cord. This process not only takes a long time, but also is prone to difficult dissection due to factors such as scar hyperplasia and adhesion at the internal ring orifice of the hernia sac.

[0004] More importantly, during the dissection of the hernia sac, it is extremely easy to cause damage to the spermatic cord vessels and vas deferens, resulting in postoperative complications. At the same time, bleeding during the dissection operation is also the main cause of postoperative seroma formation. In addition, since a relatively large area of the peritoneum needs to be opened, closing the peritoneum after the operation also takes a lot of time.

[0005] Although there are various laparoscopic hernia repair patches on the market currently, the designs of these patches are still based on traditional surgical concepts, and it is necessary to dissect the hernia sac and achieve abdominal wall formation of the spermatic cord. This not only increases the surgical difficulty and risk, but also prolongs the operation time. Therefore, it is necessary to develop a new type of patch that can avoid the dissection operation of the hernia sac, simplify the surgical procedure, and reduce the risk of surgical complications. Summary of the Invention

[0006] The object of the present invention is to solve the deficiencies of the prior art and provide a laparoscopic hernia repair patch with an anti-adhesion design in the middle area of the medial abdomen. The main body of the patch is made of polypropylene. A conical structure is designed at the middle position of the abdominal wall side of the patch corresponding to the internal ring orifice, which is inserted into the internal ring orifice to facilitate the positioning and fixation of the patch position. Through the innovative progressive conical structure and spiral guiding lines, precise alignment is achieved. An anti-adhesion layer is designed in the middle area of the medial abdomen of the patch, which, in cooperation with the intelligent antibacterial protection system, can complete the hernia repair operation without dissecting the hernia sac, significantly simplifying the surgical procedure and reducing the trauma risk.

[0007] To achieve the above object, the present invention adopts the following technical solutions: A laparoscopic hernia repair patch with an anti-adhesion area without dissecting the hernia sac, comprising: a conical structure at the center of the abdominal wall side of the patch is placed at the internal ring orifice to facilitate the positioning and fixation of the patch position. The main body of the patch is made of polypropylene, with a size of 15.0 cm × 10.0 cm. The middle area of the medial abdomen of the patch is designed as an anti-adhesion area. The anti-adhesion area is elliptical in shape, with a size of 6.0 cm × 5.0 cm. A conical structure is provided in the middle of the abdominal wall side of the patch, and spiral guiding lines in the clockwise direction are provided on the surface of the conical structure; the anti-adhesion area includes a double-layer composite structure, the lower layer is a PTFE film, and the upper layer is a modified hyaluronic acid coating, which is in direct contact with the abdominal viscera, and the two layers are combined through plasma treatment; a flexible transition zone is provided around the anti-adhesion area, the width of the transition zone is 1.0 cm, and the structure inside the transition zone is woven with PVDF monofilaments and arranged radially, with a spacing of 1.0 cm between two monofilaments; the peripheral polypropylene area includes an inner ring transition zone, a middle ring fixation zone, and an outer ring anchoring zone arranged in sequence from inside to outside. Through this structural design, the simplified surgical procedure without dissecting the hernia sac is realized. The conical structure, in cooperation with the spiral guiding lines, can achieve precise alignment. The double-layer composite structure effectively prevents tissue adhesion, and the multi-area design ensures the overall stability of the patch.

[0008] Preferably, the inner ring transition zone is woven with polypropylene monofilaments; the outer ring fixation zone adopts a standard diamond mesh structure and is double-woven with polypropylene monofilaments. Through this differential design of the zones, both the overall mechanical strength of the patch is ensured and the progressive transition of stress is realized, providing an excellent fixation effect and effectively preventing the patch from shifting and curling.

[0009] Preferably, it further includes an intelligent protection area arranged inside the central conical anti-adhesion area near the end. It adopts a bio-functional three-layer composite structure, including: the innermost layer is an anti-infection layer made of polycaprolactone membrane material, with microporous structures evenly distributed on the surface and silver ions loaded inside; the middle layer is a buffer layer made of elastic fibers interwoven into a honeycomb network structure; the outermost layer is a tissue interface layer made of modified chitosan material, with a micro-grooved morphology structure formed on the surface. This design triggers the release of silver ions through physiological activities to form a continuous dynamic antibacterial barrier. The synergistic effect of the three-layer structure not only provides continuous anti-infection protection but also ensures good tissue compatibility.

[0010] Preferably, an annular snap connection structure is provided between the anti-adhesion area and the peripheral polypropylene area, and one of the following structures is adopted in the connection groove: a) Implant a poly(lactic-co-glycolic acid) support ring, and the support ring has a porous network structure; b) A double-layer hydrogel system, with the inner layer being a high-strength double-network hydrogel composed of polyacrylamide / sodium alginate and the outer layer being a temperature-responsive poly(N-isopropylacrylamide) hydrogel; c) A magneto-responsive composite material, with a medical-grade epoxy resin matrix loaded with Fe3O4 nanoparticles and a phase change material protective layer coated on the outer layer, and the material is n-hexadecane.

[0011] Through these optional connection structure designs, the two functional areas can not only maintain a stable connection but also have a certain relative mobility, adapt to the natural movement of human tissues, and a suitable response mechanism can be selected according to needs.

[0012] Preferably, one of the following designs can be selected for the conical structure: a) Bionic structure design: Imitating the telescopic mechanism of sea anemone tentacles, adopting a circumferential fold design, the folds are arranged in concentric circles, and the surface adopts an overlapping micro-structure imitating snake scales, and the scale units are arranged obliquely; b) Liquid crystal elastomer material: It is in a flat state at room temperature and spontaneously forms a preset conical structure at body temperature.

[0013] These designs achieve good tissue expansion effects, reduce implantation resistance, and improve the safety and accuracy of the operation by imitating biological structure characteristics or utilizing the properties of intelligent materials.

[0014] Preferably, it includes one of the following improved structures: a) The peripheral support area adopts a magneto-responsive hydrogel structure, with a basic network composed of a polyacrylamide skeleton loaded with Fe3O4 nanoparticles, and the directional arrangement of the network structure can be achieved through an external weak magnetic field; b) The anti-adhesion layer incorporates a phase change material microcapsule system. The microcapsules have polycaprolactone as the shell material and octadecyl stearate encapsulated inside as the phase change core; c) The central conical region adopts a double-layer structure design. The inner layer is a hollow spiral support core layer made of medical-grade PEEK material, and the outer layer is a shape memory polymer grid structure; d) The peristaltic anti-adhesion layer has a three-layer structure, including an inner flexible polymer grid driving layer directly connected to the shape memory polymer layer, an intermediate buffer layer, and an outer contact layer with a periodic groove structure.

[0015] These improved structures provide more precise surgical maneuverability, a better tissue healing environment, and a more lasting anti-adhesion effect by introducing new functional materials or optimizing the structural design.

[0016] Compared with the prior art, the laparoscopic hernia repair patch of the present invention has the following remarkable beneficial effects: The laparoscopic hernia repair patch of the present invention, through the innovative composite design of the anti-adhesion area in the middle of the inner side of the patch and the peripheral polypropylene area, combined with the progressive conical structure and spiral guiding patterns, realizes a simplified surgical procedure without dissecting the hernia sac, significantly reducing the surgical trauma and the risk of neurovascular injury; at the same time, the differential design of multiple partitions and the setting of the flexible transition zone not only provide excellent mechanical strength and stability, but also effectively prevent the patch from shifting and curling; during the operation, the preperitoneal space is opened and dissected along the transition zone around the internal ring orifice. The conical structure on the abdominal wall side of the anti-adhesion area is embedded into the internal ring orifice, and the peripheral polypropylene area is placed in the preperitoneal space, and the peritoneal layer is closed in the flexible transition zone area. When using this patch, only a minimal amount of peritoneal dissection and suture fixation are required around the flexible transition zone, significantly simplifying the surgical operation steps; in addition, the intelligent protection system set in the central conical area can trigger the release of silver ions using human physiological activities to form a continuous dynamic antibacterial barrier. Coupled with the special surface treatment and multi-layer composite structure, it ensures good tissue compatibility and anti-adhesion effect, promotes the rapid integration of the patch with the surrounding tissues, provides a more comprehensive implant safety guarantee for hernia repair surgery, and effectively improves the overall treatment effect of the surgery. Description of the Drawings

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0018] Figure 1The figure is a schematic diagram of the overall structure of the patch of the present invention, including the spatial arrangement relationship and main dimensions of the central anti-adhesion area, the conical structure, the transition zone and the peripheral polypropylene area; Figure 2 It is a top view of the patch of the present invention, showing the anatomical design features of the patch being an oblong shape as a whole, being narrower at the proximal end and wider at the distal end, as well as the planar layout of each functional area; Figure 3 This is an enlarged schematic diagram of the multi-layer structure of the smart protection zone, showing in detail the microstructural characteristics of the anti-infection layer, buffer layer and tissue interface layer, as well as the silver ion release mechanism driven by physiological activities; Figure 4 Schematic diagram of the characteristics of the bionic structure patch, showing the circumferential fold design that imitates the tentacles of sea anemones and the surface microstructure that imitates snake scales, as well as its morphological changes in compressed and expanded states; Figure 5 The schematic diagram of the structure of the smart material patch illustrates the temperature-responsive deformation of the liquid crystal elastomer and the directional alignment mechanism of the magnetically responsive hydrogel. Figure 6 Schematic diagram of the structure and working mechanism of the active peristaltic anti-adhesive patch, showing the synergistic effect of the hollow spiral support core layer, shape memory polymer mesh layer and anti-adhesive layer, as well as the peristaltic movement process driven by physiological mechanical stimulation.

[0019] Figure numerals: anti-adhesion area 10; spiral guide pattern 11; flexible transition zone 12; intelligent protection area 13; anti-infection layer 131; buffer layer 132; tissue interface layer 133; peripheral polypropylene area 20; inner ring transition area 21; outer ring fixing area 22. DETAILED DESCRIPTION

[0020] The following will be combined Figures 1-6 The preferred embodiments of the present invention are described in detail. It should be noted that the following description is only a preferred embodiment of the present invention, rather than a limitation of the present invention. Those skilled in the art should understand that various modifications and variations can be made to the present invention without departing from the spirit and scope of the present invention. The scope of protection of the present invention shall be subject to the attached claims.

[0021] Embodiment 1: This embodiment provides a laparoscopic hernia repair patch that does not require free hernia sac. Its innovation lies in the composite structure design with an anti-adhesion area in the middle and a polypropylene area fixed to the periphery. The conical structure adopts a progressive conical design, combined with special spiral guiding patterns, which can easily achieve precise alignment with the internal ring orifice under laparoscopy. During implantation, the conical structure can gradually advance along the anatomical path by virtue of its geometric shape and surface features, naturally expand the internal ring orifice tissue, and finally reach the ideal embedding depth; the anti-adhesion area on the medial side of the patch is located in front of the peritoneum, forming an effective isolation and protection for abdominal viscera, so that there is no need to free the hernia sac and peritoneum in this area, reducing the original complex steps. In addition, a smart protection area is designed near the end inside the conical structure. Through a multi-layer composite structure and the mechanical stimulation generated by human physiological activities, the continuous release of silver ions is realized, thereby establishing a dynamic antibacterial barrier. This structural design can not only effectively prevent the patch from shifting and curling, but also provide active infection protection. The peripheral polypropylene area adopts a differential design with multiple partitions, which can provide good tissue compatibility while ensuring mechanical strength, and promote the rapid integration of the patch with the surrounding tissues. This design significantly simplifies the surgical operation process, greatly reduces the risks of surgical trauma and neurovascular injury, and at the same time provides a more comprehensive implant safety guarantee.

[0022] As Figures 1-2 shown, the overall shape of the patch is oblong, wider at the distal end and narrower at the proximal end to better adapt to the anatomical characteristics of the inguinal region. The patch includes: an anti-adhesion area 10 in the middle and a peripheral polypropylene area 20.

[0023] Among them, the anti-adhesion area 10 is oval in shape when viewed from above, with a size of 6.0 cm × 5.0 cm. The conical structure in the middle of the abdominal wall side of the patch has obvious protrusions, and the height can be designed to be 6 mm. It adopts a progressive conical structure, with a smaller top of about 4 mm and a root of about 12 mm, forming a three-dimensional shape that fits the internal ring orifice. The surface of the conical structure is designed with spiral guiding patterns 11 in the clockwise direction, with a pitch of 2 mm and a depth of 0.2 mm, which can provide a self-guiding effect during the placement process.

[0024] The structure of the anti-adhesion area 10 is as follows: The non-convex surface facing the abdominal cavity: It adopts an anti-adhesion material structure, including a double-layer composite structure of a PTFE membrane and a modified hyaluronic acid coating. The lower layer is a PTFE membrane with a thickness of 0.1 mm, and the upper layer is a modified hyaluronic acid coating with a thickness of 0.05 mm. The modified hyaluronic acid coating is in direct contact with the abdominal visceral organs, and the two layers are firmly bonded through plasma treatment, with a surface contact angle of 105° - 115°, which can effectively prevent tissue adhesion.

[0025] The convex surface facing the spermatic cord / inguinal canal: It adopts the same material structure as the peripheral polypropylene area 20 to promote tissue ingrowth.

[0026] A flexible transition zone 12 with a width of 1.0 cm is provided around the outside of the anti-adhesion zone. Preferably, the flexible transition zone 12 is arranged at the transition position between the anti-adhesion zone 10 and the peripheral polypropylene zone 20. The transition zone 12 is woven from PVDF monofilaments with a diameter of 0.08 mm and is arranged radially, with a spacing distance of 1.0 cm. When the patch is implanted, the conical structure on the abdominal wall side of the anti-adhesion zone 10 is inserted and fixed along the direction of the internal ring orifice. The peritoneal layer is incised and dissected along the transition zone 12 to an appropriate size area, and the peripheral polypropylene zone 20 is placed in the preperitoneal space. Among them, the spreading range of the peripheral polypropylene zone 20 in the preperitoneal space can cover the weak area around the myopectineal orifice. The conical structure on the abdominal wall side of the anti-adhesion zone 10 realizes precise embedding of the internal ring orifice through the spiral guiding pattern 11, and the peritoneal layer is closed in the flexible transition zone 12 area. Using this patch can greatly simplify the surgical process: First, only local peritoneal dissection is required outside the area covered by the predetermined flexible transition zone 12, and the dissection range is significantly reduced compared with conventional patches; Second, since the conical structure can naturally expand the internal ring orifice and achieve self-locking, and the patch around the internal ring orifice has an anti-adhesion coating, no additional dissection operation is required for the peritoneal tissue in this area; Finally, only intermittent stapling or suturing of the peritoneum along the circumferential direction of the flexible transition zone 12 is required to achieve reliable fixation of the patch. This structural layout not only significantly reduces the peritoneal area that needs to be dissected during the operation, but also avoids dissecting the hernia sac in the internal ring orifice area, greatly reducing the surgical difficulty and the risk of damage to the spermatic cord and surrounding neurovascular structures.

[0027] The flexible transition zone 12 is woven from PVDF monofilaments with a diameter of 0.08 mm, arranged radially, with a width of 1.0 cm and a spacing of 1.0 cm, and the Shore A hardness is 65 - 70. On the one hand, it can buffer the stress concentration between the conical structure and the surrounding tissues, and on the other hand, it provides good suture strength through its special weaving structure. This design not only simplifies the surgical operation steps, but also significantly reduces the surgical trauma through minimized tissue dissection and precise anatomical layer positioning, while ensuring reliable fixation of the patch.

[0028] As Figure 2As shown in the figure, the outer peripheral polypropylene area 20 of the patch of the present invention adopts a triple-zone design, namely an inner ring transition zone 21 and an outer ring fixation zone 22. The inner ring transition zone 21 is located outside the flexible transition zone 12, with a width of 3 mm. It adopts a low-density woven structure and is woven with polypropylene monofilaments with a diameter of 0.15 mm. The porosity of this area reaches 65%, which is beneficial for postoperative tissue ingrowth and at the same time provides a stress gradual transition with the central conical area. The outer ring fixation zone 22 has a width of 65 - 85 mm, adopts a standard diamond mesh structure, with a mesh size of 1.2 mm × 1.2 mm, and is double-woven with polypropylene monofilaments with a diameter of 0.12 mm. The weaving density is 55 strands / 5 cm longitudinally and 45 strands / 5 cm transversely. The fracture strength of this area is ≥120 N / cm, and the elastic modulus is 2.5 - 3.0 GPa, providing the main mechanical support for the patch and effectively preventing the edge of the patch from curling.

[0029] In addition, in order to effectively prevent implant-related infections and improve the biocompatibility of the patch, an intelligent protection zone 13 is designed on the inner side near the end of the central conical anti-adhesion zone 10 of the patch of the present invention. The intelligent protection zone 13 is located at the top of the conical structure facing the spermatic cord / inguinal canal side, forming a complete annular structure along the conical edge. Its width is 3 - 5 mm, just covering the main contact area between the conical structure and the internal ring orifice, providing protection for the spermatic cord and surrounding tissues.

[0030] The intelligent protection zone 13 adopts a bio-functional three-layer composite structure: 1. The innermost layer is the anti-infection layer 131, which is made of a polycaprolactone membrane material. Its characteristic is that stress-sensitive groups are designed in the molecular structure, making it respond to external mechanical stimuli. The surface of this layer is evenly distributed with microporous structures, and silver ions are loaded inside. When under pressure, the micropores can undergo reversible deformation, thereby regulating the release rate of silver ions.

[0031] 2. The middle buffer layer 132 adopts a special honeycomb network structure, which is woven by elastic fibers with a diameter of about 0.06 mm. This network structure has anisotropic mechanical properties, which can convert the vertical pressure into horizontal tensile force, not only buffering external impacts but also promoting the mechanical response of the anti-infection layer through structural deformation.

[0032] 3. The outermost tissue interface layer 133 adopts a modified chitosan material, and its surface is specially treated to form a morphological structure with micro-grooves. This structure not only provides a physical environment conducive to cell adhesion but also can regulate the release direction of silver ions through its special surface chemical properties.

[0033] When physiological activities such as respiratory movement, abdominal pressure changes, and contraction of tissues around the internal ring orifice occur in the human body, irregular compression, extrusion, and weak torsion will be generated on the conical end. These mechanical stimuli are converted into multi-directional stress distributions through the honeycomb network structure of the buffer layer 132, which not only protects the surrounding tissues from mechanical damage but also provides a continuous driving force for the anti-infection layer 131. Under this stress, the microporous structure in the anti-infection layer 131 undergoes controllable deformation, triggering the release of silver ions. At the same time, the micro-groove structure of the tissue interface layer 133 not only provides a good physical environment for cell growth but also can guide the diffusion of silver ions in a specific direction to ensure its best antibacterial effect in the target area.

[0034] This multi-level intelligent protection structure realizes the active protection function of the implant through the collaborative design of biomechanics-materials-cells, providing more comprehensive safety guarantees for hernia repair surgery.

[0035] Example 2: Based on Example 1, this example provides a variant of a laparoscopic hernia repair patch with a bionic structure. The central conical area of the patch mimics the telescopic mechanism of sea anemone tentacles and adopts a circumferential fold design. The folds are arranged in concentric circles, with a total of 6 layers. The height of each layer of folds is 0.8 mm, and the spacing is 1.2 mm. In the compressed state, it can be stacked to a thickness of 2.5 mm, and it will automatically expand to the original height of 6 mm after release. The surface of the conical structure adopts an overlapping micro-structure imitating snake scales. The size of each scale unit is 200 μm × 300 μm, and it is arranged at an angle of 45°, forming a unidirectional friction characteristic, which is beneficial for the cone to insert into the internal ring orifice and prevent retraction.

[0036] Example 3: Based on Example 1, this example provides an intelligent deformable hernia repair patch based on liquid crystal elastomer. The central conical area is made of liquid crystal elastomer material (LCE), which is composed of a composite of side-chain liquid crystal polymer and main-chain cross-linked network and has temperature-shape dual-responsive characteristics. At room temperature (25 °C), the conical structure is in a flat state with a thickness of only 1.2 mm; when it contacts body temperature (37 °C), the molecular chains rearrange and spontaneously form a preset conical structure within 90 seconds, with a top diameter of 4 mm, a base diameter of 25 mm, and a height of 6 mm. The surface of the cone adopts the orientation arrangement technology of liquid crystal molecules to form a periodic surface topography, which can generate directional peristaltic motion under temperature drive, contributing to the precise insertion of the cone.

[0037] The outer support area adopts a magnetoresponsive hydrogel structure. This structure consists of a polyacrylamide skeleton loaded with Fe3O4 nanoparticles (particle size 30 nm, content 3 wt%) to form a basic network, and the directional arrangement of the network structure can be achieved through an external weak magnetic field (50 mT). During the operation, a special magnetic field inducer is used to precisely control the deployment path and sequence of the patch. The network structure of the support area has a stress memory effect. After the first force-induced deformation, it will remember the deformation path, and subsequent deformations will follow the optimal path, effectively reducing tissue damage. A piezoresistive stress sensing unit is also embedded in the network structure to real-time monitor the stress state of the patch, providing an objective basis for postoperative rehabilitation evaluation.

[0038] In this invention, a phase change material microcapsule system is introduced into the anti-adhesion layer. The microcapsules have a polycaprolactone shell (wall thickness 0.5 μm) and contain octadecyl stearate as the phase change core inside. When the local temperature rises, the phase change material absorbs heat and releases it slowly, which can adjust the local temperature of the surgical site and reduce the inflammatory response. The average particle size of the microcapsules is 5 μm, and the surface density is 2000 pieces / mm². They are evenly distributed on the surface of the anti-adhesion layer through electrospinning technology.

[0039] Example 4A (Degradable Polymer Support Version): This example is a variation based on Example 1. An annular snap connection structure (width 3 mm, depth 0.5 mm) is designed between the central conical anti-adhesion area and the outer polypropylene area. A poly(lactic-co-glycolic acid) (PLGA) support ring with an initial molecular weight of 100,000 Daltons and a crystallinity of 45% is implanted in the connection groove. The thickness of this PLGA support ring is 0.3 mm, and it has a porous network structure with a porosity of 60%. It can maintain mechanical strength in the body for 30 - 45 days and then undergo controllable degradation. During the degradation process, the two areas gradually reach an adaptive position, and finally, permanent fixation is formed through the ingrowth of surrounding tissues.

[0040] Example 4B (Hydrogel Control Version): The connection structure is designed with a double-layer hydrogel system. The inner layer is a high-strength double-network hydrogel composed of polyacrylamide / sodium alginate, with a water content of 65% and a compression modulus of 0.8 MPa; the outer layer is a temperature-responsive poly(N-isopropylacrylamide) hydrogel with a thickness of 0.4 mm. In the initial state, this system maintains high elasticity and allows relative rotation of the two areas. As the outer hydrogel gradually dehydrates and shrinks at body temperature (completed in about 20 - 25 days), the inner network structure is compressed and deformed, achieving natural locking.

[0041] Example 4C (External Trigger Version): The connecting area uses a magneto-responsive composite material, which consists of a medical-grade epoxy resin matrix loaded with Fe3O4 nanoparticles with a diameter of 200 nm (content 5 wt%). After reaching the ideal position, an external high-frequency magnetic field (frequency 100 kHz, magnetic field strength 50 mT) is used to trigger local heating of the material to 65 °C for 90 seconds, resulting in cross-linking and curing of the epoxy resin, and the strength reaches 3.2 MPa. To prevent thermal damage, a phase change material (n-hexadecane, melting point 37 °C) protective layer with a thickness of 0.2 mm is coated on the outer layer of the composite material.

[0042] Each of these three solutions has its own characteristics: The 4A solution has the best biocompatibility but lower control accuracy; the 4B solution has the most natural process but weaker mechanical strength; the 4C solution has the most precise control but relatively complex operation.

[0043] Example 5: Active peristaltic anti-adhesion hernia repair patch This example is a variation based on Example 1 of this invention, providing an anti-adhesion patch that utilizes physiological mechanical properties. When the conical end is inserted into the internal ring orifice, due to physiological activities such as human breathing movement, abdominal pressure changes, and contraction of the tissues around the internal ring orifice, irregular compression, extrusion, and weak torsion will be generated on the conical end. This naturally existing mechanical stimulus provides a continuous driving source for the patch. This example utilizes this characteristic and through a special mechanical structure design, converts the irregular physiological mechanical stimulus into an orderly anti-adhesion peristalsis, realizing a purely mechanically driven anti-adhesion system.

[0044] The patch mainly consists of a central conical area, a peristaltic anti-adhesion layer, and a peripheral support area. Among them, the central conical area adopts a double-layer structure design: the inner layer is a hollow spiral support core layer made of medical-grade PEEK material (wall thickness 0.3 mm, pitch 1.5 mm), which is designed with special mechanical deformation transfer protrusions; the outer layer is a shape memory polymer grid structure (grid spacing 0.8 mm), which can generate directional deformation transfer under mechanical stress. The peristaltic anti-adhesion layer consists of a three-layer structure, including an inner flexible polymer grid driving layer directly connected to the shape memory polymer layer, a middle buffer layer, and a superhydrophobic outer contact layer with periodic grooves (width 10 μm, depth 5 μm).

[0045] When the conical area is compressed by the internal ring orifice, the spiral support structure generates controllable deformation, drives the shape memory polymer grid to generate a wavy deformation through the mechanical transfer protrusions, and transmits it outward in a circumferential wave-like manner, forming an orderly peristaltic movement, thereby continuously changing the contact state between the anti-adhesion layer and the tissue.

[0046] The protection scope of the present invention is not limited to the above specific embodiments, and also includes equivalent replacements or obvious variations within the understanding of those skilled in the art. Therefore, the examples and embodiments shown are regarded as illustrative rather than restrictive, and the present invention may cover various modifications and replacement schemes that conform to the spirit and scope of the present invention defined in the claims. All features disclosed in this specification, or all steps in the disclosed methods or processes, except for mutually exclusive features and / or steps, can be combined in any manner.

Claims

1. A laparoscopic hernia repair patch without free hernia sac, characterized in that: include: The center has an anti-adhesion zone (10) with a conical structure and a peripheral polypropylene zone (20); The anti-adhesion zone (10) is elliptical in shape, with a conical structure in the middle, and a clockwise spiral guide pattern (11) is provided on the surface of the conical structure; The anti-adhesion zone (10) comprises a double-layer composite structure, wherein the lower layer is a PTFE membrane and the upper layer is a modified hyaluronic acid coating, and the lower layer and the upper layer are bonded by plasma treatment; A flexible transition zone (12) is arranged around the root of the conical structure and is woven from PVDF monofilaments; The peripheral polypropylene zone (20) comprises an inner ring transition zone (21) and an outer ring fixing zone (22) which are arranged in sequence from the inside to the outside.

2. The free hernia sac-free laparoscopic hernia repair patch according to claim 1, characterized in that: The inner ring transition zone (21) is woven from polypropylene monofilaments; The outer ring fixing area (22) adopts a standard diamond mesh structure and is braided with a double layer of polypropylene monofilament.

3. The laparoscopic hernia repair patch without free hernia sac according to claim 1, characterized in that: It also includes an intelligent protection area (13) arranged inside the central conical anti-adhesion area (10) and close to the end: The intelligent protection area (13) forms a ring structure along the tapered edge; Adopts a biologically functional three-layer composite structure, including: The innermost layer is an anti-infection layer (131), which is made of a polycaprolactone membrane material, has a microporous structure evenly distributed on the surface, and is loaded with silver ions inside; The middle is a buffer layer (132), which is made of elastic fibers interwoven into a honeycomb network structure; The outermost layer is a tissue interface layer (133), which is made of modified chitosan material and has a micro-groove morphology structure formed on the surface.

4. The free hernia sac-free laparoscopic hernia repair patch according to claim 1, characterized in that: An annular snap-on connection structure is provided between the anti-adhesion zone (10) and the peripheral polypropylene zone (20): A polylactic-co-glycolic acid copolymer support ring is implanted in the connection groove; The support ring is in a porous mesh structure.

5. The free hernia sac-free laparoscopic hernia repair patch according to claim 4, characterized in that: The connection groove of the annular snap-on connection structure adopts a double-layer hydrogel system: The inner layer is a high-strength double-network hydrogel composed of polyacrylamide / sodium alginate; The outer layer is a temperature-responsive poly (N-isopropylacrylamide) hydrogel.

6. The free hernia sac-free laparoscopic hernia repair patch according to claim 4, characterized in that: The connection groove of the annular snap-on connection structure adopts a magnetically responsive composite material: Fe3O4 nanoparticles are loaded on a medical grade epoxy resin matrix; The outer layer is coated with a phase change material protective layer, and the material is n-hexadecane.

7. The free hernia sac-free laparoscopic hernia repair patch according to claim 1, characterized in that: The cone structure adopts a bionic structure design: It imitates the retracting mechanism of sea anemone tentacles and adopts a circumferential pleated design; The folds are arranged in concentric circles; The surface adopts an overlapping microstructure imitating snake scales, and the scale units are arranged at an angle.

8. The laparoscopic hernia repair patch without free hernia sac according to claim 1, characterized in that: The cone structure is made of liquid crystal elastomer material: It is flat at room temperature; Spontaneously forms a preset cone-shaped structure at body temperature.

9. The free hernia sac-free laparoscopic hernia repair patch according to claim 8, characterized in that: The peripheral support area adopts a magnetic responsive hydrogel structure: The basic network is composed of Fe3O4 nanoparticles loaded on a polyacrylamide skeleton; The directional arrangement of the network structure can be achieved through an external weak magnetic field.

10. The laparoscopic hernia repair patch without free hernia sac according to claim 1, characterized in that: Introducing phase change material microcapsule system into the anti-adhesion layer: The microcapsules are made of polycaprolactone as the shell material; Octadecyl stearate is wrapped inside as the phase change core.

11. The free hernia sac-free laparoscopic hernia repair patch according to claim 1, characterized in that: The central conical area adopts a double-layer structure design: The inner layer is a hollow spiral support core layer made of medical-grade PEEK material; The outer layer is a shape memory polymer grid structure.

12. The free hernia sac-free laparoscopic hernia repair patch according to claim 11, characterized in that: The creeping anti-adhesion layer consists of a three-layer structure: The inner driving layer is a flexible polymer mesh directly connected to the shape memory polymer layer; Intermediate buffer layer; The outer contact layer has a periodic groove structure.

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