A skin grafting scaffold and an implantation system

Abstract

Embodiments of the present invention provide a skin grafting stent and an implantation system, relating to the technical field of medical devices. The skin grafting stent provided by the embodiments of the present invention includes a stent body and a xenogeneic dermal membrane. The stent body is in a cylindrical shape. The xenogeneic dermal membrane is coated on the outer peripheral surface of the stent body. When the skin grafting stent is implanted into the esophagus, the stent body covers and fixes the xenogeneic dermal membrane on the ESD postoperative wound surface. The basement membrane in the xenogeneic dermal membrane can enable cells to regenerate rapidly, promote the epithelialization of the esophageal wall, and has better tissue compatibility compared with the existing stent used alone, playing a stronger role in reducing the inflammatory response and promoting tissue reconstruction, and effectively improving the problem of postoperative stenosis after ESD.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more particularly, to a skin graft stent and an implantation system. Background Art

[0002] Esophageal cancer is one of the common malignant tumors in China, ranking fifth in incidence and fourth in mortality among malignant tumors. The vast majority of patients with middle and advanced esophageal cancer seek medical treatment due to dysphagia. After comprehensive treatment, the 5-year survival rate is still less than 20%, while the 5-year survival rate of patients with early esophageal cancer can reach more than 95% after treatment. Therefore, the early treatment of esophageal cancer has become an urgent clinical problem to be solved. Early esophageal cancer refers to cancer cells confined to the esophageal mucosal layer and submucosal layer without lymph node metastasis. The main techniques for endoscopic treatment of early esophageal cancer include: endoscopic mucosal resection, endoscopic multi-ring mucosal resection, endoscopic submucosal dissection, etc. Literature reports that both traditional surgical operations and ESD for the treatment of early esophageal cancer can achieve good clinical results. Compared with traditional surgical operations, ESD treatment has the advantages of less trauma, fewer complications, faster recovery, and lower cost. Currently, endoscopic ESD treatment has become one of the main treatment techniques for early esophageal cancer.

[0003] It should be noted that: the size, depth of invasion of early esophageal cancer lesions, and damage to the esophageal muscularis propria have a greater impact on esophageal stricture after ESD. Among them, a resection range greater than 1 / 2 circumference and muscle layer damage during the operation are independent risk factors for postoperative stricture. Among them, the incidence of stricture after ESD for esophageal lesions with a resection range greater than 3 / 4 circumference is >90%, and the incidence of stricture after total circumferential resection of the esophagus is 100%. Once esophageal stricture occurs, patients will experience dysphagia, nausea, vomiting, and even inability to eat, leading to symptoms such as weight loss.

[0004] The preventive and treatment methods for esophageal stricture after ESD include:

[0005] Mechanical methods

[0006] 1. Self-expanding metal stent implantation (expanding metal stent, SEMS)

[0007] Advantages: Convenient and fast.

[0008] Disadvantages: The postoperative stricture incidence rate in the research results of Professor Ye Liping is 17.4%.

[0009] Conclusion: The curative effect is not very ideal, and restenosis will still occur in some patients after stent removal.

[0010] 2. Biodegradable stent implantation (biodegradable stent, BDS)

[0011] Advantages: The material has good biocompatibility.

[0012] Disadvantages: tissue hyperplasia reaction, stent displacement, and insufficient support.

[0013] Conclusion: This is still in the preliminary research stage, and its efficacy needs to be verified by a larger, well-designed prospective study.

[0014] 3. Endoscopic balloon dilation (EBD)

[0015] Advantages: relatively safe and effective, no perforation.

[0016] Disadvantages: It cannot prevent the formation of stenosis, but can only delay its occurrence. Patients need multiple dilation treatments, which increases the risk and cost of treatment.

[0017] Conclusion: EBD alone cannot be an ideal treatment for stenosis.

[0018] drug

[0019] 1. Oral glucocorticoids

[0020] 2. Local injection of glucocorticoids on the wound

[0021] Mechanism: Esophageal stenosis is mainly caused by the destruction and fibrosis of the muscularis propria. Reducing the mucosal inflammatory response will alleviate the destruction of the muscularis propria and delay the fibrosis process, thereby preventing stenosis.

[0022] Disadvantages: Glucocorticoids can cause blood sugar metabolism disorders in diabetic patients, and long-term use can have significant side effects, such as reduced immunity, inducing and aggravating infections, etc.

[0023] 3. Botulinum toxin type-A (BTX-A)

[0024] Mechanism: Botulinum toxin can not only inhibit smooth muscle contraction, but also inhibit collagen deposition and fibrous tissue formation, thereby inhibiting scar formation. It is widely used in plastic surgery.

[0025] Disadvantages: There are few reports and more cutting-edge research is needed to verify.

[0026] regenerative medicine

[0027] 1. Autologous cell transplantation

[0028] Mechanism: Rapid epithelial regeneration after skin damage can inhibit scar formation. It can promote the regeneration of epithelial cells in esophageal mucosal defects and prevent stenosis.

[0029] Disadvantages: The number of epithelial cells obtained by biopsy is limited. If more epithelial cells are obtained by endoscopic resection, the risks of bleeding and perforation will increase.

[0030] 2. Cell sheet transplantation

[0031] Mechanism: The isolated cells are cultured in vitro to form a cell layer, and then further formed into a cell sheet, which is transplanted onto the esophageal mucosal defect tissue.

[0032] Disadvantages: This research is only a basic research and more clinical studies are needed for verification. Summary of the Invention

[0033] The objectives of the present invention include, for example, providing a skin grafting stent that can effectively improve the problem of stenosis after esophageal ESD (endoscopic submucosal dissection) in the prior art.

[0034] The objectives of the present invention also include providing an implantation system that can effectively improve the problem of stenosis after esophageal ESD (endoscopic submucosal dissection) in the prior art.

[0035] The embodiments of the present invention can be implemented as follows:

[0036] The embodiments of the present invention provide a skin grafting stent, which includes a xenogeneic dermal membrane and a cylindrical stent body, and the xenogeneic dermal membrane covers the outer peripheral surface of the stent body.

[0037] Optionally, the xenogeneic dermal membrane includes an artificial dermal membrane or an animal dermal membrane.

[0038] Optionally, the xenogeneic dermal membrane is made of bovine skin tissue.

[0039] Optionally, the xenogeneic dermal membrane includes a xenogeneic acellular dermal matrix membrane.

[0040] Optionally, the xenogeneic dermal membrane has a cylindrical structure, and the xenogeneic dermal membrane sleeves the stent body.

[0041] Optionally, the skin grafting stent further includes a connecting member, and the connecting member is simultaneously connected to the xenogeneic dermal membrane and the stent body to fixedly connect the xenogeneic dermal membrane to the stent body.

[0042] Optionally, a plurality of through holes are provided on the xenogeneic dermal membrane, and the through holes penetrate the xenogeneic dermal membrane along the thickness direction of the xenogeneic dermal membrane.

[0043] Optionally, the stent body includes a middle section and a proximal cup mouth and a distal cup mouth provided at both axial ends of the middle section. The outer diameters of the proximal cup mouth and the distal cup mouth are both larger than the outer diameter of the middle section, and the xenogeneic dermal membrane covers the outer peripheral surface of the middle section.

[0044] Optionally, the stent body further includes a first stent recovery line, a second stent recovery line, and an extracorporeal recovery line. The first stent recovery line is disposed at the proximal cup opening, and the second stent recovery line is disposed at the distal cup opening. One end of the extracorporeal recovery line is fixedly connected to the first stent recovery line, and one end of the extracorporeal recovery line is used to extend to the outside of the body or to be connected to an invisible fixing ring.

[0045] Optionally, the stent body has a cylindrical structure formed by braiding a single wire; or,

[0046] the stent body has a segmented cylindrical structure formed by braiding multiple wires; or,

[0047] the stent body has a cylindrical structure formed by laser engraving.

[0048] Optionally, an anti-reflux structure is disposed at the distal end of the stent body, and the anti-reflux structure is used to prevent substances outside the stent body from entering the stent body from the distal end of the stent body.

[0049] Optionally, the stent body is a fully covered film structure.

[0050] An embodiment of the present invention further provides an implantation system. The implantation system includes an implanter and the above-mentioned skin graft stent. The stent body of the skin graft stent has a dilated state and a compressed state. The implanter has a receiving cavity, the skin graft stent is received in the receiving cavity, and the stent body is in the compressed state.

[0051] The beneficial effects of the skin graft stent and the implantation system according to the embodiments of the present invention include, for example:

[0052] The skin graft stent provided by the embodiment of the present invention includes a stent body and a xenogeneic dermal membrane. The stent body is cylindrical. The xenogeneic dermal membrane is coated on the outer peripheral surface of the stent body. When the skin graft stent is implanted into a human body cavity, in this embodiment, the human body cavity is the esophagus. The stent body covers and fixes the xenogeneic dermal membrane on the ESD postoperative wound surface. The basement membrane in the xenogeneic dermal membrane can enable cells to regenerate rapidly, promote the epithelialization of the esophageal wall, and has better tissue compatibility compared with the existing stent used alone, and plays a stronger role in reducing the inflammatory response and promoting tissue reconstruction, effectively improving the problem of postoperative stenosis after ESD.

[0053] An embodiment of the present invention further provides a xenogeneic implantation system. The implantation system includes the above-mentioned skin graft stent, and thus also has the beneficial effect that the skin graft stent can effectively improve the problem of postoperative stenosis after ESD. At the same time, the skin graft stent is installed in the implanter, and the skin graft stent can be implanted through the implanter, which helps to save the operation time and is convenient for doctors to learn and promote. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for use in the embodiments. It should be understood that the following drawings only show some embodiments of the present invention, and therefore should not be regarded as limiting the scope. For those of ordinary skill in the art, without creative efforts, other related drawings can also be obtained based on these drawings.

[0055] Figure 1 Schematic diagram of the overall structure of the implantation system provided by the embodiment of the present invention;

[0056] Figure 2 For Figure 1 Schematic diagram of the enlarged local structure at II in;

[0057] Figure 3 Schematic diagram of the structure of the skin grafting stent provided by the embodiment of the present invention from the first perspective;

[0058] Figure 4 Schematic diagram of the structure of the stent body in the skin grafting stent provided by the embodiment of the present invention;

[0059] Figure 5 Schematic diagram of the unfolded structure of the xenogeneic dermal membrane in the skin grafting stent provided by the embodiment of the present invention;

[0060] Figure 6 Schematic diagram of the structure of the skin grafting stent provided by the embodiment of the present invention from the second perspective;

[0061] Figure 7 Schematic diagram of the cross-sectional structure of the stent body in the skin grafting stent provided by the embodiment of the present invention;

[0062] Figure 8 Diagram during the ESD circumferential resection and skin grafting stent implantation provided by the test example of the present invention;

[0063] Figure 9 Schematic diagram of the local structure of the stent body for animal experiments provided by the test example of the present invention;

[0064] Figure 10 Diagram of epithelial cells crawling towards the center during animal experiments provided by the test example of the present invention;

[0065] Figure 11 Pathological section diagram of the second animal experiment provided by the test example of the present invention.

[0066] Icons: 10 - Implantation system; 100 - Skin graft stent; 110 - Stent body; 111 - Proximal cup; 112 - Intermediate section; 113 - Distal cup; 114 - First stent retrieval line; 115 - Second stent retrieval line; 116 - External retrieval line; 117 - Anti-reflux structure; 120 - Xenogeneic dermal membrane; 121 - Suture; 122 - Through hole; 200 - Implantor; 211 - Proximal handle; 212 - Distal handle; 221 - Inner tube; 222 - Middle tube; 223 - Outer tube; 224 - Accommodation cavity. Detailed implementation manners

[0067] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Apparently, the described embodiments are some but not all of the embodiments of the present invention. Usually, the components of the embodiments of the present invention described and illustrated in the accompanying drawings here can be arranged and designed in various different configurations.

[0068] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed present invention, but merely represents selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0069] It should be noted that like reference numerals and letters denote like items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0070] In the description of the present invention, it should be noted that if terms such as "upper", "lower", "inner", "outer", etc. are used to indicate the orientation or positional relationship, it is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the present invention is usually placed when in use. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as a limitation of the present invention.

[0071] In addition, if terms such as "first", "second", etc. are used only for distinguishing descriptions, they cannot be understood as indicating or implying relative importance.

[0072] It should be noted that the features in the embodiments of the present invention can be combined with each other without conflict.

[0073] Endoscopic submucosal dissection (ESD) for the treatment of early esophageal cancer can achieve good clinical results. Normal esophageal mucosal epithelium has a barrier function. After ESD, mucosal defects will promote immune inflammatory responses, that is, mucosal defects and inflammatory responses occur concomitantly, and over a long time, the mucosal barrier function will be lost. Ulcer repair, which is the reconstruction of the barrier function, is a complex and intertwined process that can be simply divided into three stages: inflammatory response, epithelial cell proliferation, and extracellular matrix remodeling. After epithelial defects, stimuli such as food or digestive juice, and gastric acid reflux are all stimulating factors for inflammatory responses. The inflammation gradually destroys the deeper layers of the esophagus downward, causing submucosal fibrosis and muscularis propria atrophy. About 1 week later, the inflammation disappears, and obvious proliferation of new blood vessels and fibrous tissue occurs. Epithelial cells derived from the periphery of the defect begin to proliferate and migrate. One month after the operation, the mucosal defect is gradually covered by squamous epithelium, and the esophageal submucosa is replaced by dense collagen fibers, without esophageal glands and muscularis mucosa. Although the muscularis propria is not touched during the operation, atrophy of the muscularis propria still occurs one month after the operation, ultimately leading to fibrosis.

[0074] This embodiment provides a skin graft stent 100. By disposing a xenogeneic dermal membrane 120 outside the stent body 110, after the skin graft stent 100 is implanted into the esophagus, the xenogeneic dermal membrane 120 can fully cover and be fixed on the ESD postoperative wound surface. At the same time, the self-expansion performance of the stent body 110 can ensure that the xenogeneic dermal membrane 120 is combined with the wound surface and the esophageal proper lamina propria as a whole, and can prevent the xenogeneic dermal membrane 120 from shifting before survival. At the same time, the stent body 110 can provide a radial expansion force to ensure the continuous expansion of the esophagus.

[0075] Figure 1 It is a schematic diagram of the overall structure of the implantation system 10 provided in this embodiment. Figure 2 For Figure 1 The enlarged schematic diagram of the local structure at II in Figure 3 It is a schematic diagram of the structure of the skin graft stent 100 provided in this embodiment from the first perspective. Please refer to Figures 1 - 3 Accordingly, this embodiment provides a skin graft stent 100 and correspondingly provides an implantation system 10.

[0076] The implantation system 10 includes a skin graft stent 100. At the same time, the implantation system 10 further includes an implanter 200. The implanter 200 has a receiving cavity 224, and the skin graft stent 100 is received in the receiving cavity 224. The stent body 110 of the skin graft stent 100 has an expanded state and a compressed state, and when the skin graft stent 100 is received in the receiving cavity 224, the stent body 110 is in a compressed state.

[0077] The skin grafting stent 100 includes a stent body 110 and a xenogeneic dermal membrane 120. The stent body 110 is cylindrical. The xenogeneic dermal membrane 120 is coated on the outer peripheral surface of the stent body 110. When the skin grafting stent 100 is placed into a human body cavity, in this embodiment, the human body cavity is the esophagus. The stent body 110 covers and fixes the xenogeneic dermal membrane 120 on the ESD postoperative wound surface. The basement membrane in the xenogeneic dermal membrane 120 can enable cells to regenerate rapidly, promote the epithelialization of the esophageal wall, and has better tissue compatibility compared with the existing stent used alone, play a stronger role in reducing the inflammatory response and promoting tissue reconstruction, and effectively improve the problem of postoperative stenosis after ESD.

[0078] The following further describes the skin grafting stent 100 provided in this embodiment:

[0079] Figure 4 It is a schematic structural diagram of the stent body 110 in the skin grafting stent 100 provided in this embodiment. Please refer to Figure 3 and Figure 4 . In this embodiment, the stent body 110 has a cylindrical structure formed by braiding a single metal wire, and has a through channel therein, and the channel is open at both the proximal end and the distal end of the stent body 110. After the skin grafting stent 100 is placed into the human esophagus, the esophagus is ensured to be unobstructed through the channel in the stent body 110, thereby ensuring smooth eating. Optionally, the material of the metal wire is nitinol.

[0080] It should be noted that in the description of this embodiment, the "proximal end" of a component is the end of the component close to the outside of the human body after being placed into the human body. In other words, in this embodiment, the proximal end of the stent body 110 is the end of the stent body 110 close to the human oral cavity after the skin grafting stent 100 is placed into the human esophagus. Correspondingly, the "distal end" of a component is the end of the component close to the inside of the human body after being placed into the human body. In other words, in this embodiment, the distal end of the stent body 110 is the end of the stent body 110 close to the human cardiac orifice after the skin grafting stent 100 is placed into the human esophagus.

[0081] Furthermore, the stent body 110 includes an intermediate section 112 and a proximal cup 111 and a distal cup 113 provided at the axial two ends of the intermediate section 112. Specifically, the proximal cup 111 is connected to the proximal end of the intermediate section 112, the distal cup 113 is connected to the distal end of the intermediate section 112, and the proximal cup 111, the intermediate section 112, and the distal cup 113 are integrally formed by metal wire braiding. The outer diameter of the proximal cup 111 and the outer diameter of the distal cup 113 are both larger than the outer diameter of the intermediate section 112, that is, the outer shape of the stent body 110 is dumbbell-shaped with large radial dimensions at both ends and small radial dimensions in the middle. Through the tight fit of the proximal cup 111 and the distal cup 113 with the inner wall surface of the esophagus, the stent displacement can be effectively avoided. The xenogeneic dermal membrane 120 is coated on the outer peripheral surface of the intermediate section 112.

[0082] In this embodiment, the stent body 110 has a fully covered film structure, that is, a film is covered on the net barrel-shaped structure formed by braiding a single metal wire, so as to close the mesh holes to make the stent body 110. The stent body 110 with a fully covered film structure helps to prevent human tissues from passing through the mesh holes into the inside of the stent body 110, and also helps to avoid problems such as food or digestive juice irritating the wound surface and then inducing an inflammatory reaction.

[0083] It should be noted that the structure of the stent body 110 is not limited here. It can be understood that in other embodiments, the structure of the stent body 110 can also be set according to requirements. For example, the stent body 110 can be set as a cylindrical structure formed by laser engraving, that is, the stent body 110 is an engraved stent, or the stent body 110 can be set as a segmented cylindrical structure formed by braiding multiple metal wires. Specifically, each metal wire braids to form a section of net barrel-shaped structure, and multiple sections of net barrel-shaped structures are connected in sequence to form a segmented cylindrical structure.

[0084] The xenogeneic dermal membrane 120 is a membrane with dermal characteristics. It can be either an artificial dermal membrane or an animal dermal membrane. That is, the xenogeneic dermal membrane 120 can be a membrane synthesized artificially with a dermal matrix and capable of skin grafting, or a membrane directly obtained by treating animal skin. Optionally, the xenogeneic dermal membrane 120 can be made of bovine skin tissue. It can be understood that in other embodiments, according to requirements, the skin tissues of other animals, such as pigs, sheep, horses, and donkeys, can also be used. As long as the xenogeneic dermal membrane 120 made can enable cells to regenerate rapidly and promote the epithelialization of the tube wall.

[0085] It should be noted that in practical applications, the "xenogeneic dermal membrane 120" mentioned in this embodiment can also be called an allogeneic dermal membrane, etc. At the same time, since the xenogeneic dermal membrane 120 can play a role in skin grafting, it can also be called a xenogeneic skin grafting membrane. Similarly, names such as artificial skin grafting membrane and allogeneic skin grafting membrane should be understood to be within the scope of the xenogeneic dermal membrane 120.

[0086] Furthermore, the xenogeneic dermal membrane 120 includes a xenogeneic acellular dermal matrix membrane, which is a membrane containing extracellular matrix components and a three-dimensional spatial structure reticular structure obtained by decellularizing xenogeneic skin tissue. Specifically, the xenogeneic dermal membrane 120 is made by subjecting bovine skin tissue to decellularization treatment, inactivating viruses and pathogens, and freeze-drying. Among them, decellularization treatment is to remove highly antigenic cellular components in the skin tissue, including the epidermis, skin appendages (hair follicles, sebaceous glands, sweat glands, etc.), vascular endothelial cells, fibroblasts, etc. in the dermis, and subcutaneous adipose tissue, and can retain the basement membrane in the skin. After the xenogeneic dermal membrane 120 is covered and fixed on the wound surface, the basement membrane can promote rapid cell regeneration.

[0087] The main component of the xenogeneic dermal membrane 120 is collagen, and it has high stability, which is convenient for transportation and storage at room temperature. Moreover, it has excellent water reabsorbability and can be completely restored in a short time. At the same time, since the xenogeneic dermal membrane 120 is not artificially chemically synthesized, it is closer to the components of human natural tissues, greatly reducing the probability of postoperative immune reactions. And it has a natural non-crosslinked property, is safe and effective, and has a large amount of available tissue. The tissue healing process can be completely absorbed and utilized without producing a foreign body sensation.

[0088] At the same time, it should be noted that in practical applications, the xenogeneic acellular dermal matrix membrane can also be called a xenogeneic acellular skin graft matrix membrane, a xenogeneic acellular dermal membrane, or a xenogeneic acellular skin graft membrane, etc.

[0089] Figure 5 Schematic diagram of the unfolded structure of the xenogeneic dermal membrane 120 in the skin graft support 100 provided in this embodiment. Please refer to Figure 3 and Figure 5 Furthermore, a plurality of through holes 122 are provided on the xenogeneic dermal membrane 120, and the through holes 122 penetrate the xenogeneic acellular matrix membrane along the thickness direction of the xenogeneic dermal membrane 120. By opening the through holes 122 on the xenogeneic dermal membrane 120, it is beneficial for drainage and can reduce the formation of postoperative seromas. Optionally, the through holes 122 are horseshoe-shaped.

[0090] Figure 6 Schematic diagram of the structure of the skin graft support 100 provided in this embodiment from a second perspective. Please refer to Figure 3 , Figure 5 and Figure 6 Furthermore, the xenogeneic dermal membrane 120 has a cylindrical structure, and the xenogeneic dermal membrane 120 sleeves the support body 110. Specifically, the xenogeneic dermal membrane 120 is a square sheet, and its opposite ends are sutured together by a suture 121 to form a cylindrical structure. The cylindrical xenogeneic dermal membrane 120 sleeves the middle section 112 of the support body 110 and completely covers it circumferentially.

[0091] Further, the skin grafting stent 100 further includes a connecting member (not shown in the figure), and the connecting member is connected to both the xenogeneic dermal membrane 120 and the stent body 110 at the same time to fixedly connect the xenogeneic dermal membrane 120 to the stent body 110.

[0092] Specifically, the connecting member is a connecting line, and the connecting line passes through the xenogeneic dermal membrane 120 and the stent body 110 at the same time, so as to fixedly connect the xenogeneic dermal membrane 120 to the stent body 110. After the tubular xenogeneic dermal membrane 120 is sleeved on the middle section 112 of the stent body 110, since the radial dimensions of both the proximal cup mouth 111 and the distal cup mouth 113 are larger than the radial dimension of the middle section 112, the axial position of the xenogeneic dermal membrane 120 can be limited by the proximal cup mouth 111 and the distal cup mouth 113 in this way. By connecting the connecting line to both the xenogeneic dermal membrane 120 and the stent body 110 at the same time, the circumferential position of the xenogeneic dermal membrane 120 can be limited. At the same time, in order to facilitate cutting or pulling apart the connecting line to separate the xenogeneic dermal membrane 120 from the stent body 110, the connecting line does not need to be set too tightly, and it can prevent the xenogeneic dermal membrane 120 from rotating circumferentially relative to the stent body 110 during connection.

[0093] Please refer to again Figure 3 and Figure 4 In this embodiment, the stent body 110 further includes a first stent recovery line 114, a second stent recovery line 115 and an external recovery line 116. The first stent recovery line 114 is arranged at the proximal cup mouth 111, and the second stent recovery line 115 is arranged at the distal cup mouth 113. One end of the external recovery line 116 is fixedly connected to the first stent recovery line 114, and one end of the external recovery line 116 is used to extend to the outside of the body or be connected to the invisible fixing ring.

[0094] Specifically, the first stent recovery line 114 is arranged at the proximal edge of the proximal cup mouth 111. During use, by clamping the first stent recovery line 114, the proximal cup mouth 111 can be deformed under an external force to be separated from the esophageal wall surface. The second stent recovery line 115 is arranged at the distal edge of the distal cup mouth 113. During use, by clamping the second stent recovery line 115, the distal cup mouth 113 can be deformed under an external force to be separated from the esophageal wall surface, so as to facilitate the removal of the stent body 110.

[0095] One end of the in vitro recovery line 116 is fixedly connected to the first bracket recovery line 114. The other end of the in vitro recovery line 116 extends to the outside of the body through the nasal cavity and is fixed outside the body, so as to prevent the skin grafting bracket 100 from shifting when the skin grafting bracket 100 is placed in the human esophagus. It can be understood that in other embodiments, the end of the in vitro recovery line 116 far from the first bracket recovery line 114 can also be connected to an invisible fixing ring according to requirements. For example, an invisible nasal ring is arranged in the human nasal cavity, and by fixing the in vitro recovery line 116 to the invisible nasal ring (not shown in the figure), the problem of the skin grafting bracket 100 shifting can be avoided, and the in vitro recovery line 116 is fixed to the invisible nasal ring, avoiding the problem of affecting the appearance caused by the in vitro recovery line 116 being exposed outside the body.

[0096] Figure 7 It is a schematic cross-sectional structure diagram of the bracket body 110 in the skin grafting bracket 100 provided in this embodiment. Please refer to Figure 7 , the bracket body 110 further includes an anti-reflux structure 117, and the anti-reflux structure 117 is used to prevent substances outside the bracket body 110 from entering the bracket body 110 from the distal end of the bracket body 110. Specifically, the anti-reflux structure 117 is an anti-reflux membrane flap. By arranging an anti-reflux membrane flap at the distal end of the bracket body 110, the internal channel of the bracket body 110 is unidirectionally smooth along the direction from the proximal end to the distal end, which can not only ensure that the bracket body 110 will not affect eating when it is located in the human esophagus, but also prevent the problem that gastric acid reflux enters the bracket body 110 from the distal end of the bracket body 110 and then stimulates the wound surface.

[0097] It should be noted that the specific structure of the anti-reflux structure 117 is not limited here. It can be understood that in other embodiments, it can also be specifically set according to requirements. For example, the shape of the anti-reflux membrane flap can be set as a nipple shape, etc.

[0098] According to a skin grafting bracket 100 provided in this embodiment, the use process and working principle of the skin grafting bracket 100 are as follows:

[0099] During use, the skin graft stent 100 is placed into the human esophagus through an introducer 200, and then the skin graft stent 100 is released at the wound surface after ESD. Under the self-expansion effect of the stent body 110, the stent body 110 is in an expanded state and supports on the esophageal wall surface, so that the xenogeneic dermal membrane 120 coated outside the stent body 110 fully covers and is fixed on the wound surface. At the same time, the self-expansion of the stent body 110 can ensure that the xenogeneic dermal membrane 120 is combined with the wound surface and the esophageal muscularis propria into one body, and the xenogeneic dermal membrane 120 will not fold, which can effectively prevent the xenogeneic dermal membrane 120 from shifting before survival. At the same time, the stent body 110 can also provide a radial expansion force to maintain the continuous expansion of the esophagus. Then, one end of the external recovery line 116 far from the first stent recovery line 114 is fixed on the invisible nose ring, and the skin graft stent 100 is fixed through the external recovery line 116 to prevent the skin graft stent 100 from shifting.

[0100] After the skin graft stent 100 is placed in the human esophagus for 3-6 weeks, the connecting line is cut to separate the stent body 110 from the xenogeneic dermal membrane 120, and then the stent body 110 is taken out, and the xenogeneic dermal membrane 120 is continuously maintained in the esophagus until the esophageal wall is epithelialized, and the xenogeneic dermal membrane 120 degrades in the body.

[0101] A skin graft stent 100 provided in this embodiment has at least the following advantages:

[0102] The skin graft stent 100 provided in this embodiment is provided with a xenogeneic dermal membrane 120 outside the stent body 110. The xenogeneic dermal membrane 120 retains biomechanical properties. After being placed in the esophagus, the xenogeneic dermal membrane 120 fully covers and is fixed on the wound surface after ESD under the auxiliary action of the stent body 110. The basement membrane retained in the xenogeneic dermal membrane 120 can enable cells to regenerate rapidly and promote esophageal wall epithelialization. The self-expansion of the stent body 110 can ensure that the xenogeneic dermal membrane 120 is combined with the wound surface and the esophageal muscularis propria into one body and is fixed relative to the esophagus and the xenogeneic dermal membrane 120 does not fold, preventing the xenogeneic dermal membrane 120 from shifting before survival. At the same time, the stent body 110 can also provide a radial expansion force to maintain the continuous expansion of the esophagus, effectively improving the problem of postoperative esophageal stenosis. This skin graft stent 100 has good tissue compatibility, can play a stronger role in reducing the inflammatory response and promoting tissue reconstruction, and has a good market prospect.

[0103] Please refer to Figure 1 and Figure 2, this embodiment also provides an implantation system 10, which includes an implanter 200 and the above-mentioned skin graft stent 100. The implanter 200 has a receiving cavity 224, and the skin graft stent 100 is received in the receiving cavity 224, and the stent body 110 of the skin graft stent 100 is in a compressed state. During use, the skin graft stent 100 is released at the ESD postoperative position through the implanter 200. Under the self-expansion effect of the stent body 110, the stent body 110 is in an expanded state and is supported and fixed in the esophagus.

[0104] Specifically, the implanter 200 is a conventional OTW (Over through the wire) implanter 200, which includes a handle and an inner tube 221, a middle tube 222, and an outer tube 223 that are sleeved with each other. The distal end face of the middle tube 222 is closer to the handle relative to the distal end face of the inner tube 221 and the distal end face of the outer tube 223. Thus, a receiving cavity 224 is formed by the inner wall surface of the outer tube, the distal end face of the middle tube 222, and the outer wall surface of the inner tube 221. The skin graft stent 100 is sleeved on the inner tube 221 and is received in the receiving cavity 224. The handle includes a proximal handle 211 and a distal handle 212. The outer tube 223 is fixedly connected to the distal handle 212, the middle tube 222 abuts against a boosting tube (not shown in the figure) fixedly connected to the proximal handle 211, and at the same time, the inner tube 221 is fixedly connected to the proximal handle 211. In this way, during use, by operating the proximal handle 211 and the distal handle 212 to move relatively closer, the inner tube 221 can be pushed out of the outer tube 223. At the same time, the distal end face of the middle tube 222 abuts against the skin graft stent 100 in the receiving cavity 224 and pushes the skin graft stent 100 away from the outer tube 223, realizing the release of the skin graft stent 100.

[0105] By loading the skin graft stent 100 into the implanter 200 and forming the product of the implantation system 10 through sterilization packaging, doctors can directly use it, saving surgical time, without additional complex and cumbersome procedures, and facilitating doctors' learning and promotion.

[0106] Test Example

[0107] The skin graft stent 100 is used for the prevention and treatment of esophageal stricture after ESD in pigs.

[0108] The first animal experiment: By performing circumferential resection of the esophagus of pigs and implanting the skin graft stent 100, the xenogeneic dermal membrane 120 of the skin graft stent 100 is made to fit the wound surface (as Figure 8 shown). During the experiment, due to the difficulty in expanding the stent body 110, the upper mouth was dilated with a balloon. Two days later, it was found that the animals gasped significantly and died five days later. During the autopsy, it was seen that the barbs on the stent body 110 (as Figure 9 shown) pierced into the serosal side of the pigs, causing pleural effusion and adhesion of the right lung. At the same time, the case results showed that epithelial cells could be seen crawling towards the center (as Figure 10As shown), and this process occurred 5 days after the operation, it can be seen that the skin graft stent 100 has demonstrated its advantages.

[0109] Second animal experiment: The stent body 110 was adjusted to shorten the barb length from 2.2 mm in the first animal experiment to 1.0 mm, and the animal experiment was conducted again according to the steps of the first animal experiment. Figure 11 The pathological sections of the animal experiment are shown. The experimental results show that the skin graft stent 100 did not shift during the experiment, there was no obvious hyperplasia of the esophagus after the operation, and epithelial growth was visible while the submucosal fibrous tissue proliferated, which was consistent with the expected results. The animal experiment was successful. When conducting animal experiments, because animals cannot use an in vitro recovery line, a barb structure is added to the stent body 110.

[0110] When the skin graft stent 100 provided in the embodiment of the present invention is used in clinical practice on humans, the addition of a barb structure in the stent body 110 may pose a risk of puncturing the patient's esophagus or causing complications. Therefore, the barbs on the stent body 110 in animal experiments are improved to be connected with an extracorporeal retrieval line 116 that is connected to the first stent retrieval line 114 and the stent body 110. The extracorporeal retrieval line 116 is fixed at the base of the ear or at an invisible nose ring, and the stent body 110 is fixed to the patient's site, thereby achieving an equivalent anti-displacement effect.

[0111] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. A skin graft stent for the treatment of esophageal stricture after endoscopic mucosal resection of the esophagus, endoscopic multi-ring mucosal ligation resection of the esophagus, and endoscopic submucosal dissection of the esophagus, characterized in that, It includes a xenogeneic dermal membrane (120), a cylindrical stent body (110) and a connecting member. The xenogeneic dermal membrane (120) is coated on the outer peripheral surface of the stent body (110); the connecting member is connected to both the xenogeneic dermal membrane (120) and the stent body (110) at the same time to fixedly connect the xenogeneic dermal membrane (120) to the stent body (110); the stent body (110) is used to cover and fix the xenogeneic dermal membrane (120) on the ESD postoperative wound surface; The xenogeneic dermal membrane (120) includes an artificial dermal membrane or an animal dermal membrane; the xenogeneic dermal membrane (120) includes a xenogeneic acellular dermal matrix membrane; the xenogeneic acellular dermal matrix membrane is a membrane containing extracellular matrix components and a three-dimensional spatial structure reticular structure obtained by decellularization treatment of xenogeneic skin tissues; the main component of the xenogeneic dermal membrane is collagen; The xenogeneic dermal membrane (120) has a cylindrical structure, and the xenogeneic dermal membrane (120) sleeves the stent body (110); An anti-reflux structure (117) is provided at the distal end of the stent body (110), and the anti-reflux structure (117) is used to prevent substances outside the stent body (110) from entering the stent body (110) from the distal end of the stent body (110).

2. The skin grafting stent according to claim 1, wherein, The xenogeneic dermal membrane (120) is made of bovine skin tissue.

3. The skin grafting scaffold according to claim 1, characterized in that, A plurality of through holes (122) are provided on the xenogeneic dermal membrane (120), and the through holes (122) penetrate the xenogeneic dermal membrane (120) along the thickness direction of the xenogeneic dermal membrane (120).

4. The skin grafting stent according to claim 1, wherein, The stent body (110) includes an intermediate section (112) and a proximal cup (111) and a distal cup (113) provided at both axial ends of the intermediate section (112). The outer diameters of the proximal cup (111) and the distal cup (113) are both larger than the outer diameter of the intermediate section (112), and the xenogeneic dermal membrane (120) is coated on the outer peripheral surface of the intermediate section (112).

5. The skin grafting scaffold according to claim 4, wherein The stent body (110) further includes a first stent recovery line (114), a second stent recovery line (115) and an in vitro recovery line (116). The first stent recovery line (114) is provided on the proximal cup (111), and the second stent recovery line (115) is provided on the distal cup (113); one end of the in vitro recovery line (116) is fixedly connected to the first stent recovery line (114), and one end of the in vitro recovery line (116) is used to extend to the outside of the body or to be connected to an invisible fixing ring.

6. The skin grafting stent according to claim 1, characterized in that, The stent body (110) has a cylindrical structure formed by braiding a single metal wire; or, The stent body (110) has a segmented cylindrical structure formed by braiding multiple metal wires; or, The stent body (110) has a cylindrical structure formed by laser engraving.

7. The skin grafting scaffold according to any one of claims 1-6, characterized in that, The stent body (110) is a fully covered membrane structure.

8. An implantation system, characterized in that, The implanting system (10) includes an implanter (200) and a skin graft support (100) according to any one of claims 1-7. The support body (110) of the skin graft support (100) has a dilated state and a compressed state. The implanter (200) has a receiving cavity (224), the skin graft support (100) is received in the receiving cavity (224), and the support body (110) is in the compressed state.

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