Biological glue patch applied to non-invasive repair of dura mater

Abstract

The invention relates to a biological glue patch applied to non-invasive repair of dura mater, and relates to the technical field of medical biological materials. The biological glue patch comprises a patch base material, a biological membrane layer is arranged on one side of the patch base material, a hydrophobic membrane layer is arranged on the outer side of the biological membrane layer, a vacuum cavity is formed between the inner side of the biological membrane layer and the side portion of the patch base material, and biological glue is arranged in the vacuum cavity; one side, facing the biological membrane layer, of the patch base material is provided with a stabbing part for stabbing the biological membrane layer and the hydrophobic membrane layer. According to the biological glue patch, repairing of the dura mater is achieved in a glue adhesion mode, pinholes are avoided, the phenomenon of leakage of cerebrospinal fluid is avoided, meanwhile, the biological glue is protected through the biological film layer and the hydrophobic film layer, and the biological glue is prevented from being solidified and adhered in advance; the biological glue is released by arranging the stabbing part, the operation is simple, and the device can be applied to repairing the dural mater injury by a non-invasive single-side dual-channel spine endoscope technology.

Description

Technical Field

[0001] The present application relates to the technical field of medical biomaterials, and in particular to a bioglue patch for non-invasive repair of dura mater. Background Art

[0002] Spinal dura mater injuries can be divided into iatrogenic and non-iatrogenic. Iatrogenic injuries can be divided into unplanned surgical injuries and planned surgical incisions. Planned surgical incisions occur due to post-traumatic spinal cord edema, intradural tumor resection, or lesions of the dura mater itself (such as meningioma), requiring dural incision to decompress or remove the lesion. Non-iatrogenic injuries primarily refer to high-energy trauma (such as vertebral burst fractures) that directly result in broken bone fragments puncturing the dura mater.

[0003] Spinal surgery holds a vital position in modern medicine. With the continuous advancement of medical technology, the types and methods of spinal surgery are becoming increasingly diverse, bringing hope of treatment to many patients with spinal diseases. However, dural injury and cerebrospinal fluid leakage, as common complications (unintended surgical injuries) of spinal surgery, pose numerous challenges to patients and medical practitioners. These complications can lead to a range of clinical problems, such as pseudomeningocele, central nervous system infection, and wound dehiscence. These complications not only prolong hospital stays and increase medical costs, but also significantly increase the risk of infection, and a small number of patients may even require revision surgery. Therefore, during spinal surgery, any dural injury and cerebrospinal fluid leakage that occur require prompt treatment.

[0004] Clinically, dura mater injuries are divided into five degrees based on the ratio of the transverse diameter of the dura mater injury to the circumference of the dural sac: degree 1, dura mater tear but no defect; degree 2, dura mater defect <1 / 4 circumference; degree 3: dura mater defect 1 / 4 to 1 / 2 circumference; degree 4: dura mater defect >1 / 2 circumference, but not completely absent; degree 5: complete absence of the dura mater. Clinically, the treatment of dura mater injury and cerebrospinal fluid leakage is mainly divided into two aspects: intraoperative repair and postoperative conservative treatment. For intraoperative repair of dura mater injury, suture repair and repair with the application of repair materials are mainly used. Different treatment methods are adopted for different degrees of dura mater injury. For example, dura mater injuries of degrees 1-3 are generally repaired by direct suturing or autologous tissue coverage, supplemented by bioprotein glue to enhance sealing; dura mater injuries of degrees 4-5 require the use of fascia sheets combined with suture fixation. In addition, artificial repair materials such as bioprotein glue and polyglycolic acid mesh can also be used to improve repair efficiency, while titanium clips are suitable for high-pressure leakage. Postoperative conservative treatment options are only suitable for patients with minor dural injuries, and patients still need a long recovery time, which reduces their quality of life.

[0005] Previous studies have shown that, in most cases, suture repairs are prone to leakage around the suture holes. Even the use of supplemental biomaterials cannot completely prevent cerebrospinal fluid leakage from the suture holes, and also increases the risk of infection, damage to the cauda equina, and tissue adhesions. However, research on repair materials lacks reports on the clinical application of dura mater, and lacks research on the repair capacity, biocompatibility, and adaptability of repair materials to physiological conditions.

[0006] Currently, when spinal surgeons discover a patient with dura mater injury during routine spinal endoscopic surgery, they often need to switch to posterior spinal open surgery for safe and effective repair. For delayed dura mater injury after surgery, conservative treatment is generally performed first. If the complications are severe, a second open surgery is performed. For patients who need to undergo surgical dura mater incision, posterior spinal open surgery is also usually chosen for treatment. Posterior spinal open surgery is highly invasive and has a slow recovery. In recent years, with the gradual deepening of the concept of non-invasive surgery and the improvement of spinal endoscopic technology, spinal endoscopic surgery has many advantages over open spinal surgery, such as less trauma and shorter postoperative recovery time, and has been favored by more and more patients. Among spinal endoscopes, unilateral dual-channel spinal endoscopy technology combines the observation channel with the operation channel, which is more flexible and efficient than other spinal endoscopic technologies.

[0007] Currently, due to the specific location of dura mater patches, previous methods have been unable to effectively apply pressure (to prevent damage to the nerves within the dura mater), nor can they be fixed to the dura mater using adhesive methods. Furthermore, spinal endoscopy is performed under flowing water, and the adhesive portion of the dura mater patch must maintain good adhesive strength in the water environment to effectively repair the dura mater. Some researchers have attempted to repair dura mater injuries with fibrin patches under unilateral, dual-channel spinal endoscopy. However, for complex dura mater injuries, since there are currently no dura mater patches specifically for endoscopic use, open surgery is still necessary for repair. This has limited the development and application of unilateral, dual-channel spinal endoscopy technology. Summary of the Invention

[0008] In order to repair dura mater damage using non-invasive unilateral dual-channel spinal endoscopy technology and reduce cerebrospinal fluid leakage, the present application provides a bio-glue patch for non-invasive repair of dura mater.

[0009] The present application provides a bioadhesive patch for non-invasive repair of the dura mater, which adopts the following technical solution: A bioglue patch for non-invasive repair of the dura mater comprises a patch substrate, one side of which is provided with a biofilm layer having good tissue compatibility with the dura mater, an outer side of which is provided with a hydrophobic film layer, a vacuum cavity formed between the inner side of the biofilm layer and the side of the patch substrate, and bioglue disposed in the vacuum cavity; The patch substrate has a thorn portion on a side facing the biofilm layer for piercing the biofilm layer and the hydrophobic film layer.

[0010] The biological glue in this application can be converted from "liquid" to "solid" to bond tissues; the biological glue is located in the vacuum cavity between the biofilm layer and the patch substrate to prevent the biological glue from solidifying and bonding prematurely, so as to achieve the purpose of convenient transportation and storage. The biofilm layer in this application protects the biological glue, has good tissue compatibility, and will not produce biological or chemical reactions with the dura mater; the hydrophobic film layer in this application can effectively prevent water from penetrating into the biological glue under the aqueous medium in the spine, causing it to lose its adhesiveness. When in use, under the aqueous medium of the spinal endoscope, after effective pressing with a surgical instrument, the thorns on the patch substrate can be used to easily squeeze and puncture the biofilm layer and the hydrophobic film layer. After the biofilm layer and the hydrophobic film layer are ruptured, the biological glue is squeezed out, so that the patch substrate is effectively bonded to the dura mater or another patch substrate. Thus, the wound repair of the dura mater is achieved.

[0011] By adopting the above technical solution, the bioglue patch in the present application uses bioglue to adhere the patch and tissue to repair the dura mater, without pinholes, and completely avoids the phenomenon of cerebrospinal fluid leakage from the pinholes. At the same time, the bioglue in the present application is located in the vacuum cavity between the biofilm layer and the patch substrate, which is convenient for transportation and long-term storage. The bioglue is not easy to fail. The biofilm layer and the hydrophobic film layer protect the bioglue to prevent the liquid from contacting the bioglue in advance and causing the bioglue to solidify and fail. The biofilm layer in the present application has good tissue compatibility with the dura mater and will not cause abnormal reactions. In the present application, by providing a protruding part, the release of the bioglue can be very easily achieved by squeezing with surgical instruments. The operation is simple, and it can effectively bond the damaged part of the dura mater in a flowing water medium environment, and can be used for non-invasive unilateral dual-channel spinal endoscopy technology to repair dura mater damage.

[0012] Optionally, the planar area of ​​the biofilm layer is smaller than the planar area of ​​the patch substrate and the biofilm layer is located in the middle of the patch substrate; The biofilm layer is rectangular, circular or oval; The spur portion is a "cross" shaped ridge structure.

[0013] The shape of the patch substrate can be cut or preset according to the wound condition of the dura mater; the center position of the protruding portion is opposite to the center position of the biofilm layer. By adopting the above technical solution, when the surgical instrument presses the patch substrate, it can ensure that the biofilm layer and the hydrophobic film layer are instantly ruptured, so that the biological glue can quickly contact the dura mater part to complete effective bonding. The protruding portion of the "cross" ridge structure can pierce the biofilm layer and the hydrophobic film layer more accurately and quickly, and produce a larger rupture, which is convenient for the biological glue to flow out quickly and be used to adhere the patch substrate and the dura mater. The plane area of ​​the biofilm layer is smaller than the patch substrate and is located in the middle position, which can make the scope of action of the biological glue more concentrated and effective when the patch is bonded, avoiding overflow.

[0014] Optionally, the outer side of the edge and the end of the protruding portion are both smooth structures.

[0015] By adopting the above technical solution, the protruding part can be prevented from causing secondary damage to the dura mater during the pressurization process.

[0016] Optionally, the patch substrate includes a first portion and a second portion connected to each other; the first portion is circular, oval or rectangular, and the second portion is connected to one side of the first portion; The first part and the second part are integrally formed, or the first part and the second part are integrally formed and fixedly connected together; The biological membrane layer, the hydrophobic membrane layer and the biological glue are independently arranged on the first part and the second part.

[0017] During use, two bio-glue patches can be combined and used, with the first portion of one bio-glue patch attached to one side of the dura mater wound, and the first portion of the other bio-glue patch attached to the other side of the dura mater wound, with the second portions of the two bio-glue patches relatively attached together. In this application, the connection between the first portion of the patch substrate and the dura mater, as well as the connection between the second portions of the two patch substrates, are achieved by squeezing and puncturing the bio-film layer and the hydrophobic film layer with a surgical instrument, and then using the flowing bio-glue to achieve adhesion. This prevents the formation of pinholes and facilitates surgical manipulation.

[0018] By adopting the above technical solution, the flexibility and manufacturability of the patch structure are improved, and it is easy to use. Different parts of the patch can effectively adhere to the dura mater or patch substrate under the aqueous medium of spinal endoscopy, facilitating non-invasive dura mater repair.

[0019] Optionally, one end of the second part is fixedly connected to the first part, and the other end of the second part protrudes from one side of the first part and can be bent toward one side of the first part to form an L-shape with the cross section of the first part.

[0020] By adopting the above technical solution, two different patch substrates can be easily glued together using a clamping tool; in this application, two patches can be used to repair complex or large-incision dura mater injuries in a flowing water medium environment, meeting the use requirements of unilateral dual-channel spinal endoscopy technology, reducing the trauma of dura mater injury repair surgery, and shortening postoperative recovery time.

[0021] Optionally, the patch substrate includes a first patch and a second patch that are independent of each other; the first patch and the second patch are independently provided with the biofilm layer, the hydrophobic film layer and the bioglue; The first patch is provided with an annular loop suture, the coil root of the loop suture is fixed on the side of the first patch away from the biofilm layer, and the exposed pull-line portion of the loop suture extends outward; The second patch is provided with a barbed fixing line, one end of the barbed fixing line is a line head fixed on the side of the second patch away from the biofilm layer, and the other end of the barbed fixing line is an exposed portion extending outward.

[0022] The patches in this application are used in pairs, with different sutures provided on each patch, and the paired sutures cooperate to achieve the connection between the two patches. By adopting the above technical solution, without generating pinholes, the first patch and the second patch are respectively adhered to the dura mater on both sides of the wound using biological glue, and the first patch and the second patch are connected by a ring-shaped suture and a barbed fixing line that cooperate with each other. The operation is simple, the cost is low, and the use is stable and reliable. The first patch is provided with an annular ring-shaped suture with an exposed pull-wire portion extending outward, and the second patch is provided with a barbed fixing line with an exposed portion. This facilitates the insertion of the second patch through the annular coil structure of the first patch during spinal endoscopy, thereby closing the two sides of the dura mater injury and achieving non-invasive dura mater repair.

[0023] Optionally, the loop suture and the barb fixing line are both absorbable sutures; the coil root fixing position of the loop suture is opposite to the center of the biofilm layer on the first patch, and the thread head fixing position of the barb fixing line is opposite to the center of the biofilm layer on the second patch.

[0024] By adopting the above technical solution, postoperative suture removal can be avoided, reducing patient pain and infection risks; the fixed position of the coil root of the loop suture is opposite to the center of the biofilm layer on the first patch, and the fixed position of the wire head of the barbed fixing line is opposite to the center of the biofilm layer on the second patch, which can evenly transmit force to the surfaces of the first patch and the second patch, and greatly improve the stability and reliability of the connection between the two, enhance the adhesion effect between the patch and the dura mater, and achieve non-invasive repair of dura mater damage.

[0025] Optionally, the patch substrate includes a first patch and a second patch that are independent of each other; the first patch and the second patch are independently provided with the biofilm layer, the hydrophobic film layer and the bioglue; The first patch is provided with an annular loop-type barbed wire, the coil root of the loop-type barbed wire is fixed on the side of the first patch away from the biofilm layer, and the exposed pull wire portion of the loop-type barbed wire extends outward; The second patch is provided with a fixing suture, one end of the fixing suture is a thread head fixed on the side of the second patch away from the biofilm layer; the other end of the fixing suture is an exposed portion extending outward.

[0026] This technical solution provides another matching suture connection structure. By adopting the above technical solution, the first patch and the second patch can be connected to each other very conveniently and quickly.

[0027] Optionally, the loop-type barbed wire and the fixed suture are both absorbable sutures; the fixed position of the coil root of the loop-type barbed wire is opposite to the center of the biofilm layer on the first patch, and the fixed position of the thread head of the fixed suture is opposite to the center of the biofilm layer on the second patch.

[0028] By adopting the above technical solution, postoperative suture removal can be avoided, reducing patient pain and infection risks; the fixed position of the coil root of the loop-type barbed wire is opposite to the center of the biofilm layer on the first patch, and the fixed position of the wire head of the fixed suture is opposite to the center of the biofilm layer on the second patch, which can evenly transmit force to the surfaces of the first patch and the second patch, greatly improving the stability and reliability of the suture connection, enhancing the adhesion effect between the patch and the dura mater, and realizing non-invasive repair of dura mater damage.

[0029] Optionally, the patch substrate is made of a biological protein glue material, a polyglycolic acid material, a non-cross-linked collagen material, or a synthetic material of silk fibroin and PEG; The biological glue is made of polyethylene glycol hydrogel, or made of fibrinogen and fibrinolysis inhibitor; The biofilm layer is made of acellular dermal matrix material, cross-linked collagen membrane material, silk fibroin membrane material, or nanocellulose composite membrane material; The hydrophobic membrane layer is made of expanded polytetrafluoroethylene membrane material, polycaprolactone nanofiber membrane material or fluorinated polymer membrane material.

[0030] By adopting the above technical scheme, the patch base material is made of biological protein glue material, polyglycolic acid material, non-cross-linked collagen material, silk fibroin and PEG synthetic material, which can ensure that the patch has suitable physical properties and biocompatibility; polyethylene glycol hydrogel or fibrinogen and fibrinolysis inhibitor are used to make biological glue, which can achieve effective adhesion between the patch and the dura mater; acellular dermal matrix material, cross-linked collagen membrane material, silk fibroin membrane material, and nanocellulose composite membrane material are used to make the biological membrane layer, which can protect the biological glue and have good tissue compatibility with the dura mater; expanded polytetrafluoroethylene membrane material, polycaprolactone nanofiber membrane material, and fluorinated polymer membrane material are used to make the hydrophobic membrane layer, which can prevent water from penetrating into the biological glue part under the aqueous medium of spinal endoscopy and causing it to lose its adhesiveness.

[0031] In summary, this application includes at least one of the following beneficial technical effects: 1. The bio-glue patch in this application uses bio-glue to adhere the patch and tissue to repair the dura mater, without the appearance of pinholes, and completely avoids the phenomenon of cerebrospinal fluid leakage from the pinholes.

[0032] 2. The bioglue in this application is located in the vacuum cavity between the biofilm layer and the patch substrate, which is convenient for transportation and long-term storage, and the bioglue is not easy to lose effectiveness.

[0033] 3. In this application, the biofilm layer and the hydrophobic film layer are used to protect the bioglue. The hydrophobic properties of the hydrophobic film layer are used to effectively prevent the liquid from coming into contact with the bioglue prematurely, which would cause the bioglue to solidify and fail. At the same time, the biofilm layer in this application has good tissue compatibility with the dura mater and will not cause abnormal reactions.

[0034] 4. In this application, a protruding portion is provided on the patch substrate, and the release of biological glue can be easily achieved by squeezing with surgical instruments. The operation is simple, and it can effectively adhere to the damaged part of the dura mater in a flowing water medium environment. It can be used in non-invasive unilateral dual-channel spinal endoscopy technology to repair dura mater damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is a schematic structural diagram of the bio-glue patch in this application.

[0036] Figure 2 This is a schematic diagram of the bonding process between the bioglue patch and the dura mater in this application.

[0037] Figure 3 This is a schematic diagram of the structure of two bio-glue patches in Example 1 of the present application from a frontal perspective.

[0038] Figure 4 This is a schematic diagram of the back view of the two bio-glue patches in Example 1 of the present application.

[0039] Figure 5 This is a schematic diagram of the process of bonding two bioglue patches in Example 1 of the present application.

[0040] Figure 6 This is a side view of the operation of bonding two bioglue patches in Example 1 of the present application.

[0041] Figure 7 This is a schematic diagram of the process of bonding two bioglue patches during surgery in Example 1 of the present application.

[0042] Figure 8 This is a schematic diagram of the front view of the first patch and the second patch in Example 2 of the present application.

[0043] Figure 9 This is a schematic diagram of the back view of the first patch and the second patch in Example 2 of the present application.

[0044] Figure 10 This is a schematic diagram of the first patch and the second patch being bonded together during surgery in Example 2 of the present application.

[0045] Figure 11 This is a schematic diagram of the front view of the first patch and the second patch in Example 3 of the present application.

[0046] Figure 12 This is a schematic diagram of the first patch and the second patch being bonded together during surgery in Example 3 of the present application.

[0047] In the picture: 10. Patch base material; 11. Protruding portion; 12. First portion; 13. Second portion; 14. First patch; 15. Second patch; 20. Bio-glue unit; 21. Vacuum chamber; 22. Bio-glue; 30. Biofilm layer; 40. Hydrophobic membrane layer; 50. Loop suture; 60. Barbed fixed line; 70. Looped barbed wire; 80. Fixing sutures; 90, dura mater; 100. Surgical instruments. DETAILED DESCRIPTION

[0048] The following will be combined with the Figure 1 -Attached Figure 12The technical solutions in the embodiments of the present invention are clearly and completely described. The described embodiments are only possible technical implementations of the present invention and do not constitute a complete implementation. Those skilled in the art can fully combine the embodiments of the present invention to derive other embodiments without inventive work, and such embodiments are also within the scope of protection of the present invention.

[0049] Example 1

[0050] Reference Figure 1 and Figure 2 As shown, the bioglue patch used for non-invasive repair of the dura mater in the present application includes a patch substrate 10, a bioglue portion 20, a biofilm layer 30 and a hydrophobic film layer 40. The biofilm layer 30 is fixedly connected to one side of the patch substrate 10; a vacuum cavity 21 is formed between the inner side of the biofilm layer 30 and the side of the patch substrate 10, and bioglue 22 is poured into the vacuum cavity 21 to form the bioglue portion 20. The bioglue 22 can be converted from "liquid" to "solid" for tissue adhesion; the hydrophobic film layer 40 is attached to the outer side of the biofilm layer 30.

[0051] In this embodiment, the patch substrate 10 can be made of biological protein glue material, polyglycolic acid material, non-cross-linked collagen material, or a synthetic material of silk fibroin and PEG, which can ensure that the patch has suitable physical properties and biocompatibility; the biological glue 22 can be made of polyethylene glycol hydrogel, or made of fibrinogen and fibrinolysis inhibitor, which can achieve effective adhesion between the patch and the dura mater 90 in a flowing water medium environment; the biological membrane layer 30 can be made of acellular dermal matrix material, cross-linked collagen membrane material, silk fibroin membrane material, or nanocellulose composite membrane material, and the biological membrane layer 30 has good tissue compatibility with the dura mater 90; the hydrophobic membrane layer 40 can be made of expanded polytetrafluoroethylene membrane material, polycaprolactone nanofiber membrane material, or fluorinated polymer membrane material, which can effectively prevent water from penetrating into the 20-minute biological glue part under the water medium of spinal endoscopy, causing it to lose its adhesion.

[0052] Reference Figure 1As shown, in this embodiment, the patch substrate 10 has a protruding portion 11 on the side facing the biofilm layer 30, which is used to puncture the biofilm layer 30 and the hydrophobic film layer 40. When the surgical instrument 100 presses the patch substrate 10, the protruding portion 11 ensures that the biofilm layer 30 and the hydrophobic film layer 40 are instantly ruptured, allowing the bioglue 22 to quickly contact the dura mater 90, achieving effective bonding. Furthermore, in this application, the planar area of ​​the biofilm layer 30 is smaller than that of the patch substrate 10, and the biofilm layer 30 is located in the middle of the patch substrate 10. This smaller planar area of ​​the biofilm layer 30 than that of the patch substrate 10 and its central location ensure that the bioglue 22 has a more concentrated and effective range of action during patch bonding, preventing overflow. The shape of the patch substrate 10 can be cut or preset according to the wound condition of the dura mater 90; for example, the patch substrate 10 can be designed into a cuttable rectangular shape with a plane length and width of 5cmX5cm, 5cmX10cm, 10cmX10cm, and a thickness of 1mm. The biofilm layer 30 can be rectangular, circular, or elliptical; the bioglue portion 20 can be circular with a plane radius of 1mm and a thickness of 0.5mm; the thorn portion 11 has a "cross" shaped corrugated structure, and the center of the thorn portion 11 is directly opposite the center of the biofilm layer 30. The thorn portion 11 with a "cross" shaped corrugated structure can pierce the biofilm layer 30 and the hydrophobic film layer 40 more accurately and quickly, and create a larger rupture to facilitate the rapid outflow of the bioglue 22 for adhesion of the patch substrate 10 to the dura mater 90. The outer edge and end of the thorn portion 11 are smooth structures to prevent the thorn portion 11 from causing secondary damage to the dura mater 90 during the pressurization process.

[0053] See also Figure 3 and Figure 4 As shown, in this embodiment, the patch substrate 10 includes a first portion 12 and a second portion 13 that are connected. The first portion 12 is circular, oval, or rectangular, and the second portion 13 is connected to one side of the first portion 12. The first portion 12 and the second portion 13 are integrally formed, or the first portion 12 and the second portion 13 are separately formed and then fixed together. The first portion 12 and the second portion 13 are each independently provided with a biofilm layer 30, a hydrophobic film layer 40, and a bioglue 22. Furthermore, one end of the second portion 13 is fixedly connected to the first portion 12, and the other end of the second portion 13 protrudes from one side of the first portion 12 and can be bent toward the side of the first portion 12 to form an L-shaped cross-section with the first portion 12.

[0054] When using, refer to Figure 5 、 Figure 6 and Figure 7As shown, two bio-glue patches can be combined and used, wherein the first part 12 of one bio-glue patch is pasted on one side of the wound of the dura mater 90, and the first part 12 of the other bio-glue patch is pasted on the other side of the wound of the dura mater 90, and the second parts 13 of the two bio-glue patches are relatively fitted together. In the present application, the connection between the first part 12 of the patch substrate 10 and the dura mater 90 and the connection between the second parts 13 of the two patch substrates 10 are both achieved by squeezing and puncturing the bio-film layer 30 and the hydrophobic film layer 40 with a surgical instrument 100, and the outflowing bio-glue 22 is used for adhesion, so that pinholes are not formed and surgical manipulation is convenient. In the above structure, it is convenient to use a clamping tool to easily adhere two different patch substrates 10 together; in the present application, two patches can be used to repair complex or large wounds of the dura mater 90 in a flowing water medium environment, meeting the use requirements of unilateral double-channel spinal endoscopy technology, reducing the trauma of dura mater 90 damage repair surgery, and shortening postoperative recovery time.

[0055] The patch substrate 10, biological glue 22, biological membrane layer 30 and hydrophobic membrane layer 40 in this embodiment are all existing materials, which can be directly purchased from outside or prepared according to existing technologies.

[0056] For example, the patch substrate 10 may utilize the substrate described in Chinese patent application number CN201921326114X (publication number CN211068233U; publication date July 24, 2020). Alternatively, the patch substrate 10 may utilize a synthetic patch suitable for repairing extra-abdominal inguinal and femoral hernias, developed and produced by Beijing Shunxing Biotechnology Co., Ltd., a subsidiary of Beijing Compat Medical. When the patch substrate 10 is made of bioprotein glue, its source may include decellularized animal tissue (e.g., porcine small intestinal submucosa, dermis, or pericardium).

[0057] The biological glue 22 can use the biological glue in the Chinese patent application document with patent application number CN2025101497611 (publication number: CN119909220A; publication date: 2025-05-02); the biological glue 22 can also use the Compat brand laparoscopic medical glue produced by Beijing Compat Medical Equipment Co., Ltd., which is a colorless or slightly yellow transparent liquid and can start to solidify in 3 to 5 seconds when used.

[0058] Biomembrane layer 30 can utilize the biomembrane material described in Chinese patent application number 2021106098130 (publication number: CN113304321A; publication date: August 27, 2021). Alternatively, biomembrane layer 30 can be directly sourced from the New Rui nerve repair membrane produced by Shandong Junxiu Biotechnology Co., Ltd. This membrane is derived from porcine peripheral nerve extracellular matrix (acellular matrix), is less than 100 microns thick, and forms a transparent or translucent film. This membrane, prepared from animal nerve tissue, is suitable for human nerve repair, preserving the natural extracellular matrix structure and bioactive factors.

[0059] The hydrophobic film layer 40 can be prepared using the polytetrafluoroethylene film preparation method described in the Chinese patent application document with patent application number CN2017107779091 (publication number: CN107837691B; publication date: 2020-02-14) to prepare the polytetrafluoroethylene film as the hydrophobic film layer 40 in this application.

[0060] The implementation principle is as follows: When performing a non-invasive dura mater 90 repair using two L-shaped bio-glue patches, a surgical instrument 100 is used within the operating channel, under spinal endoscopy, to quickly push one of the bio-glue patches onto the surface of the dura mater 90 on the damaged side of the dura mater 90 and press it. This causes the first portion 12 of the bio-glue patch to adhere to the surface of the dura mater 90. Similarly, the first portion 12 of the other bio-glue patch is adhered to the surface of the dura mater 90 on the other side of the dura mater 90. Then, under spinal endoscopy, the surgical instrument 100 is used to align the second portions 13 of the two bio-glue patches, pressing them together to securely adhere them to each other with the bio-glue 22, thereby achieving unilateral, dual-channel spinal endoscopy for non-invasive dura mater 90 repair.

[0061] In this application, the bioglue 22 is located within the vacuum chamber 21 between the biofilm layer 30 and the patch substrate 10, preventing premature solidification and adhesion of the bioglue 22, thereby facilitating transport and storage. The biofilm layer 30 in this application protects the bioglue 22, exhibiting excellent tissue compatibility and preventing biological or chemical reactions with the dura mater 90. The hydrophobic film layer 40 in this application effectively prevents water from penetrating the bioglue 22 and causing it to lose its adhesive properties in the aqueous medium of the spinal column. During use, under the aqueous medium of a spinal endoscope, after effective pressure is applied with a surgical instrument 100, the protruding spikes 11 on the patch substrate 10 can easily squeeze and puncture the biofilm layer 30 and the hydrophobic film layer 40. Once the biofilm layer 30 and the hydrophobic film layer 40 are ruptured, the bioglue 22 is extruded, effectively bonding the patch substrate 10 to the dura mater 90 or another patch substrate 10, thereby repairing the wound in the dura mater 90.

[0062] The bioglue patch in the present application uses bioglue 22 to adhere the patch and tissue to repair the dura mater 90, without pinholes, and completely avoids the phenomenon of cerebrospinal fluid leakage from the pinholes. At the same time, the bioglue 22 in the present application is located in the vacuum cavity 21 between the biofilm layer 30 and the patch substrate 10, which is convenient for transportation and long-term storage. The bioglue 22 is not easy to fail. The biofilm layer 30 and the hydrophobic film layer 40 protect the bioglue 22 to prevent the liquid from contacting the bioglue 22 in advance and causing the bioglue 22 to solidify and fail. The biofilm layer 30 in the present application has good tissue compatibility with the dura mater 90 and will not cause abnormal reactions. In the present application, by providing a protruding portion 11, the release of the bioglue 22 can be easily achieved by squeezing the surgical instrument 100, and the operation is simple. It can effectively bond the damaged part of the dura mater 90 in a flowing water medium environment, and can be used for non-invasive unilateral double-channel spinal endoscopy technology to repair dura mater 90 damage.

[0063] This application innovatively develops a bio-glue patch that can effectively and safely repair the dura mater 90 in an aqueous medium, breaking through the technical bottleneck of traditional repair methods in non-invasive procedures. In response to the clinical pain points of closure difficulties, insufficient stability, and secondary injury risks in the repair of dura mater 90 injuries during spinal endoscopic surgery, the technical solution in this application has constructed a modular repair system that can adapt to different anatomical sites and injury morphologies through the collaborative innovation of composite biomaterial engineering design and clinical spinal endoscopy technology. This type of bio-glue patch can achieve effective adhesion to the damaged part of the dura mater 90 in a flowing water medium environment. At the same time, it has good biocompatibility with the tissue of the dura mater 90 itself, so as to achieve the purpose of non-invasive dura mater 90 repair.

[0064] Example 2

[0065] Reference Figure 8 and Figure 9As shown, this embodiment is substantially the same as embodiment 1, except that the patch substrate 10 in this embodiment includes a first patch 14 and a second patch 15 that are independent of each other; the first patch 14 and the second patch 15 are independently provided with a biofilm layer 30, a hydrophobic film layer 40 and a biological glue 22; the first patch 14 is provided with a ring-shaped loop-type suture 50, the coil root of the loop-type suture 50 is fixed on the side of the first patch 14 away from the biofilm layer 30, and the exposed pulling line portion of the loop-type suture 50 extends outward; the second patch 15 is provided with a barb fixing line 60, one end of the barb fixing line 60 is a line head fixed on the side of the second patch 15 away from the biofilm layer 30, and the other end of the barb fixing line 60 is an exposed portion extending outward. Furthermore, the loop suture 50 and the barb fixing thread 60 are both absorbable sutures; the fixed position of the coil root of the loop suture 50 is opposite to the center position of the biofilm layer 30 on the first patch 14, and the fixed position of the thread head of the barb fixing thread 60 is opposite to the center position of the biofilm layer 30 on the second patch 15.

[0066] The implementation principle is as follows: the patches in this application are used in pairs, and different sutures are set on each of the two patches, and the paired sutures cooperate to achieve the connection between the two patches. Specifically, the bio-glue patch in this application is a bio-glue patch with a line, combined with Figure 10 As shown, when using the bio-adhesive patch with thread, a non-invasive dura mater 90 repair operation is performed. A surgical instrument 100 is used within the operating channel of a spinal endoscope to place a first patch 14 on the surface of the dura mater 90 on the damaged side of the dura mater 90 and press the patch to adhere to the surface of the dura mater 90. A second patch 15 is passed through the coil structure of the loop suture 50 on the first patch 14 and pushed to the surface of the dura mater 90 on the other side of the dura mater 90. The patch is then pressed under an aqueous medium to adhere to the surface of the dura mater 90. The exposed portion of the barbed fixing thread 60 connected to the second patch 15 is then tightened externally, and the exposed pull line portion of the loop suture 50 on the first patch 14 is pulled to close the damaged sides of the dura mater 90. After closure, the suture is continued, and the excess suture is cut with scissors.

[0067] The technical solution of this embodiment, without creating pinholes, is that the first patch 14 and the second patch 15 are respectively adhered to the dura mater 90 on both sides of the wound using biological glue 22. The first patch 14 and the second patch 15 are connected by a loop suture 50 and a barbed fixing wire 60 that cooperate with each other. This is simple to operate, low cost, and stable and reliable in use. The first patch 14 is provided with an annular loop suture 50 with an exposed pull-line portion extending outward, and the second patch 15 is provided with a barbed fixing wire 60 with an exposed portion. This facilitates the insertion of the second patch 15 through the coil structure of the loop suture 50 on the first patch 14 during spinal endoscopy, thereby closing the damaged sides of the dura mater 90 and achieving non-invasive repair of the dura mater 90. The loop suture 50 and the barb fixing thread 60 used in this application are both absorbable sutures, which can avoid postoperative suture removal and reduce patient pain and infection risks; the coil root of the loop suture 50 is fixed at the center of the biofilm layer 30 on the first patch 14, and the thread head of the barb fixing thread 60 is fixed at the center of the biofilm layer 30 on the second patch 15, which can evenly transmit force to the surfaces of the first patch 14 and the second patch 15, and greatly improve the stability and reliability of the connection between the two, enhance the bonding effect between the patch and the dura mater 90, and achieve non-invasive repair of dura mater 90 damage.

[0068] Example 3

[0069] Reference Figure 11 and Figure 12 As shown, this embodiment is substantially the same as Example 2, except that the suture structures on the first patch 14 and the second patch 15 are different. Specifically, in this embodiment, the first patch 14 is provided with an annular, looped barbed thread 70. The base of the looped barbed thread 70 is fixed to the side of the first patch 14 facing away from the biofilm layer 30, and the exposed pull-through portion of the looped barbed thread 70 extends outward. The second patch 15 is provided with a fixed suture 80. One end of the fixed suture 80 is fixed to the side of the second patch 15 facing away from the biofilm layer 30, and the other end of the fixed suture 80 is an exposed portion extending outward. In this embodiment, both the looped barbed thread 70 and the fixed suture 80 are absorbable sutures. The base of the looped barbed thread 70 is fixed directly opposite the center of the biofilm layer 30 on the first patch 14, while the base of the fixed suture 80 is fixed directly opposite the center of the biofilm layer 30 on the second patch 15.

[0070] This embodiment provides another matching suture connection structure, which can also easily and quickly connect the first patch 14 and the second patch 15. Its implementation principle and technical effect are basically the same as those of embodiment 2 and will not be repeated here.

[0071] The examples of this specific embodiment are all preferred embodiments of this application and are not intended to limit the scope of protection of this application. Identical components are represented by the same reference numerals. Therefore, any equivalent changes made based on the structure, shape, and principle of this application should be included in the scope of protection of this application.

Claims

1. A bioglue patch for non-invasive repair of dura mater, comprising a patch substrate (10), characterized in that: A biofilm layer (30) having good tissue compatibility with the dura mater (90) is provided on one side of the patch substrate (10), a hydrophobic film layer (40) is provided on the outside of the biofilm layer (30), a vacuum cavity (21) is formed between the inner side of the biofilm layer (30) and the side of the patch substrate (10), and biological glue (22) is provided in the vacuum cavity (21); The patch substrate (10) has a protruding portion (11) on the side facing the biofilm layer (30) for piercing the biofilm layer (30) and the hydrophobic film layer (40).

2. The bioglue patch for non-invasive repair of dura mater according to claim 1, characterized in that: The planar area of ​​the biofilm layer (30) is smaller than the planar area of ​​the patch substrate (10), and the biofilm layer (30) is located in the middle of the patch substrate (10); The biofilm layer (30) is rectangular, circular or elliptical; The thorn portion (11) is a "cross" shaped ridge structure.

3. The bioglue patch for non-invasive repair of dura mater according to claim 2, characterized in that: The outer side of the edge and the end of the thorn portion (11) are both smooth structures.

4. The bioglue patch for non-invasive repair of dura mater according to claim 1, 2 or 3, characterized in that: The patch substrate (10) includes a first portion (12) and a second portion (13) connected to each other; the first portion (12) is circular, oval or rectangular, and the second portion (13) is connected to one side of the first portion (12); The first part (12) and the second part (13) are integrally formed, or the first part (12) and the second part (13) are separately formed and then fixedly connected together; The biological membrane layer (30), the hydrophobic membrane layer (40) and the biological glue (22) are independently arranged on the first part (12) and the second part (13).

5. The bioglue patch for non-invasive repair of dura mater according to claim 4, characterized in that: One end of the second part (13) is fixedly connected to the first part (12), and the other end of the second part (13) protrudes from one side of the first part (12) and can be bent toward one side of the first part (12) to form an L-shape with the cross section of the first part (12).

6. The bioglue patch for non-invasive repair of dura mater according to claim 1, 2 or 3, characterized in that: The patch substrate (10) comprises a first patch (14) and a second patch (15) that are independent of each other; the biofilm layer (30), the hydrophobic film layer (40) and the bioglue (22) are independently provided on the first patch (14) and the second patch (15); The first patch (14) is provided with an annular loop-type suture (50), the coil root of the loop-type suture (50) is fixed on the side of the first patch (14) facing away from the biofilm layer (30), and the exposed pull-line portion of the loop-type suture (50) extends outward; The second patch (15) is provided with a barbed fixing line (60), one end of the barbed fixing line (60) is a line head fixed to the side of the second patch (15) facing away from the biofilm layer (30), and the other end of the barbed fixing line (60) is an exposed portion extending outward.

7. The bioglue patch for non-invasive repair of dura mater according to claim 6, characterized in that: The loop suture (50) and the barb fixing thread (60) are both absorbable threads; the fixed position of the coil root of the loop suture (50) is opposite to the center position of the biofilm layer (30) on the first patch (14), and the fixed position of the thread head of the barb fixing thread (60) is opposite to the center position of the biofilm layer (30) on the second patch (15).

8. The bioglue patch for non-invasive repair of dura mater according to claim 1, 2 or 3, characterized in that: The patch substrate (10) comprises a first patch (14) and a second patch (15) that are independent of each other; the biofilm layer (30), the hydrophobic film layer (40) and the bioglue (22) are independently provided on the first patch (14) and the second patch (15); The first patch (14) is provided with an annular loop-type barbed wire (70), the coil root of the loop-type barbed wire (70) is fixed on the side of the first patch (14) away from the biofilm layer (30), and the exposed pull-wire portion of the loop-type barbed wire (70) extends outward; A fixing suture (80) is provided on the second patch (15), one end of the fixing suture (80) is a thread head fixed to the side of the second patch (15) facing away from the biofilm layer (30); the other end of the fixing suture (80) is an exposed portion extending outward.

9. The bioglue patch for non-invasive repair of dura mater according to claim 8, characterized in that: The loop-type barbed wire (70) and the fixed suture (80) are both absorbable sutures; the fixed position of the coil root of the loop-type barbed wire (70) is opposite to the center of the biofilm layer (30) on the first patch (14), and the fixed position of the thread head of the fixed suture (80) is opposite to the center of the biofilm layer (30) on the second patch (15).

10. The bioglue patch for non-invasive repair of dura mater according to claim 1, characterized in that: The patch substrate (10) is made of a biological protein glue material, a polyglycolic acid material, a non-crosslinked collagen material, or a synthetic material of silk fibroin and PEG; The biological glue (22) is made of polyethylene glycol hydrogel, or made of fibrinogen and fibrinolysis inhibitor; The biofilm layer (30) is made of acellular dermal matrix material, cross-linked collagen membrane material, silk fibroin membrane material, or nanocellulose composite membrane material; The hydrophobic membrane layer (40) is made of expanded polytetrafluoroethylene membrane material, polycaprolactone nanofiber membrane material, or fluorinated polymer membrane material.

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