A biological glue patch applied to non-invasive repair of dura mater

Abstract

The application relates to a biological glue patch applied to noninvasive repair of a dura mater, and relates to the technical field of medical biomaterials. The biological glue patch comprises a patch base material, one side of the patch base material is provided with a biological membrane layer, the outer side of the biological membrane layer is provided with a hydrophobic membrane layer, a vacuum cavity is formed between the inner side of the biological membrane layer and the side of the patch base material, and biological glue is arranged in the vacuum cavity; and the side of the patch base material facing the biological membrane layer is provided with a piercing part for piercing the biological membrane layer and the hydrophobic membrane layer. The biological glue patch in the application realizes repair of the dura mater in a glue adhesion mode, needle holes do not occur, the phenomenon of cerebrospinal fluid leakage is avoided, meanwhile, the biological membrane layer and the hydrophobic membrane layer protect the biological glue, and prevent the biological glue from being prematurely solidified and bonded; the piercing part is arranged to release the biological glue, the operation is simple, and the biological glue patch can be applied to noninvasive unilateral double-channel endoscopic spinal surgery for repairing dura mater injury.

Description

Technical Field

[0001] This application relates to the field of medical biomaterials technology, and in particular to a bio-adhesive patch for non-invasive repair of the dura mater. Background Technology

[0002] Spinal cord injuries can be classified into iatrogenic and non-iatrogenic injuries. Iatrogenic injuries can be further divided into unintended surgical injuries and planned surgical incisions. Planned surgical incisions are necessary due to spinal cord trauma-induced edema, removal of intradural tumors, or lesions in the dura mater itself (such as meningiomas), requiring decompression or removal of the lesion. Non-iatrogenic injuries mainly refer to high-energy trauma (such as burst fractures of the vertebral body) that directly cause fragmented bone to puncture the dura mater.

[0003] Spinal surgery plays a vital role in modern medicine. With continuous advancements in medical technology, the types and methods of spinal surgery have become increasingly diverse, bringing hope to many patients with spinal diseases. However, dural injury and cerebrospinal fluid leakage, as common complications (unintended surgical injuries) in spinal surgery, pose significant challenges to both patients and medical professionals. These complications can lead to a range of clinical problems, such as pseudomeningocele, central nervous system infection, and wound dehiscence. They not only prolong hospital stays and increase medical costs but also significantly increase the risk of infection; in some cases, revision surgery may even be necessary. Therefore, timely management is crucial in spinal surgery should any dural injury or cerebrospinal fluid leakage.

[0004] Clinically, dural injuries are classified into five degrees based on the ratio of the transverse diameter of the dural tear to the circumference of the dural sac: Grade 1: dural tear without defect; Grade 2: dural defect <1 / 4 circumference; Grade 3: dural defect 1 / 4 to 1 / 2 circumference; Grade 4: dural defect >1 / 2 circumference, but not completely absent; Grade 5: complete absence of the dura mater. Clinical treatment for dural injuries and cerebrospinal fluid leakage mainly falls into two categories: intraoperative repair and postoperative conservative treatment. Intraoperative repair of dural injuries primarily employs suture closure and the use of repair materials. Different treatment methods are used for different degrees of dural injuries. For example, grade 1-3 dural injuries are generally repaired by direct suturing or autologous tissue coverage, supplemented with biological protein glue to enhance sealing; grade 4-5 dural injuries require fascia grafts combined with suture fixation. In addition, artificial repair materials such as bio-protein adhesives and polyglycolic acid mesh can be used to improve repair efficiency, while titanium clips are suitable for high-pressure leakage. Postoperative conservative treatment is only suitable for patients with minor spinal cord injuries, and these patients still need a long recovery period, reducing their quality of life.

[0005] Previous studies have shown that, in most cases, suture repair is prone to leakage around the suture needle holes. Even with the addition of auxiliary biomaterials, it is impossible to completely prevent cerebrospinal fluid leakage from these needle holes, and it also increases the risks of infection, damage to the cauda equina, and tissue adhesions. Furthermore, research on repair materials lacks reports on their clinical application in the dura mater, and studies on their repair capabilities, biocompatibility, and adaptability to physiological conditions are also lacking.

[0006] Currently, when spinal surgeons discover dural injuries during routine spinal endoscopic surgery, a posterior open spinal approach is often necessary for safe and effective repair. For postoperative delayed dural injuries, conservative treatment is usually initiated initially; if complications become severe, a second open surgery is performed. Posterior open spinal surgery is also commonly chosen for patients requiring planned dural incision. Posterior open spinal surgery is more invasive and has a slower recovery time. In recent years, with the increasing emphasis on minimally invasive surgery and advancements in spinal endoscopic techniques, spinal endoscopic surgery has gained popularity among patients due to its advantages over open spinal surgery, including less trauma and shorter recovery time. Among spinal endoscopy techniques, unilateral dual-channel spinal endoscopy, through the coordination of the observation and manipulation channels, offers greater flexibility and efficiency compared to other spinal endoscopic techniques.

[0007] Currently, due to the specific location of their application, traditional methods cannot effectively apply pressure (to prevent damage to nerves within the dura mater) to dural patches, nor can adhesive methods be used to fix the patch to the dura mater. Furthermore, spinal endoscopy is performed in a flowing water environment, requiring the adhesive portions of the patch to maintain good adhesion strength for effective dural repair. Some researchers have attempted to repair dural injuries with fibrin patch packing under unilateral dual-channel spinal endoscopy; however, for complex dural injuries, since there are currently no dural patches specifically designed for endoscopic use, open surgery is still necessary. This limits the development and application of unilateral dual-channel spinal endoscopy. Summary of the Invention

[0008] In order to achieve the repair of dural injuries using non-invasive unilateral dual-channel spinal endoscopy and reduce cerebrospinal fluid leakage, this application provides a bio-adhesive patch for non-invasive dural repair.

[0009] The bio-glue patch for non-invasive repair of the dura mater provided in this application adopts the following technical solution:

[0010] A bio-adhesive patch for non-invasive repair of the dura mater includes a patch substrate, a biofilm layer with good tissue compatibility with the dura mater is disposed on one side of the patch substrate, a hydrophobic membrane layer is disposed on the outer side of the biofilm layer, and a vacuum cavity is formed between the inner side of the biofilm layer and the side of the patch substrate, wherein bio-adhesive is disposed in the vacuum cavity.

[0011] The patch substrate has protrusions on the side facing the biofilm layer for piercing the biofilm layer and the hydrophobic membrane layer.

[0012] The bio-adhesive in this application can transform from a "liquid" to a "solid" for tissue adhesion. The bio-adhesive is located within a vacuum cavity between the biofilm layer and the patch substrate, preventing premature solidification and facilitating convenient transportation and storage. The biofilm layer in this application protects the bio-adhesive, exhibiting good tissue compatibility and preventing biological or chemical reactions with the dura mater. The hydrophobic membrane layer effectively prevents water from penetrating to the bio-adhesive in an aqueous medium within the spine, thus preventing loss of adhesion. During use, under a spinal endoscope in an aqueous medium, effective pressure is applied using surgical instruments. The protrusions on the patch substrate easily puncture the biofilm and hydrophobic membrane layers. After rupture, the bio-adhesive is expelled, allowing the patch substrate to effectively adhere to the dura mater or another patch substrate, thereby achieving dura mater wound repair.

[0013] By adopting the above technical solution, the bio-adhesive patch in this application repairs the dura mater by bonding the patch and tissue with bio-adhesive, without pinholes, completely avoiding the leakage of cerebrospinal fluid through pinholes. Furthermore, the bio-adhesive is located in a vacuum cavity between the biofilm layer and the patch substrate, facilitating transportation and long-term storage. The bio-adhesive is less prone to failure, and the biofilm layer and hydrophobic film layer protect it, preventing premature contact between the liquid and the bio-adhesive, which could lead to coagulation and adhesion failure. The biofilm layer and the dura mater have good tissue compatibility and will not cause abnormal reactions. By setting protrusions, the bio-adhesive can be easily released by squeezing with surgical instruments, making the operation simple. It can effectively bond to the dura mater injury site in a flowing water medium environment and can be applied to non-invasive unilateral dual-channel spinal endoscopy for dura mater repair.

[0014] 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;

[0015] The biofilm layer is rectangular, circular, or elliptical;

[0016] The protruding part has a cross-shaped protrusion structure.

[0017] The shape of the patch substrate can be cut or pre-designed according to the wound condition of the dura mater; the center of the protrusions is aligned with the center of the biofilm layer. By employing this technical solution, when surgical instruments press on the patch substrate, the biofilm and hydrophobic membrane layers can be ensured to rupture instantaneously, allowing the bio-adhesive to quickly contact the dura mater and achieve effective adhesion. The protrusions of the "+" shaped structure can more accurately and quickly pierce the biofilm and hydrophobic membrane layers, creating a larger opening to facilitate the rapid outflow of bio-adhesive for bonding the patch substrate to the dura mater. The biofilm layer, with a smaller planar area than the patch substrate and located in the center, allows for a more concentrated and effective application of the bio-adhesive during patch bonding, preventing spillage.

[0018] Optionally, the outer edge and end of the protrusion are both smooth structures.

[0019] By adopting the above technical solution, secondary damage to the dura mater caused by the protruding part can be prevented during the pressurization process.

[0020] Optionally, the patch substrate includes a first part and a second part connected together; the first part is circular, elliptical or rectangular, and the second part is connected to one side of the first part;

[0021] The first part and the second part are integrally formed, or the first part and the second part are integrally formed and then fixed together.

[0022] The first and second parts are each independently provided with the biofilm layer, the hydrophobic membrane layer and the bio-adhesive.

[0023] In use, two bioadhesive patches can be combined. The first part of one bioadhesive patch is adhered to one side of the dura mater wound, and the first part of the other bioadhesive patch is adhered to the other side of the dura mater wound. The second parts of the two bioadhesive patches are then bonded together. In this application, the connection between the first part of the patch substrate and the dura mater, as well as the connection between the second parts of the two patch substrates, are achieved by squeezing and piercing the biofilm layer and hydrophobic membrane layer with surgical instruments, using the flowing bioadhesive liquid for adhesion. This avoids pinhole formation and facilitates surgical manipulation.

[0024] By adopting the above technical solutions, the flexibility and manufacturability of the patch structure are improved, and it is easy to use. Different parts of the patch can be effectively bonded to the dura mater or patch substrate under the aqueous medium of spinal endoscopy, which facilitates non-invasive dura mater repair.

[0025] Optionally, one end of the second part is fixed 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.

[0026] By adopting the above technical solution, two different patch substrates can be easily bonded together using a clamping tool. In this application, two patches can be used to repair complex or large dural injuries in a flowing water medium environment, meeting the requirements for the use of unilateral dual-channel spinal endoscopy technology, reducing the trauma of dural injury repair surgery, and shortening the postoperative recovery time.

[0027] 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 each independently provided with the biofilm layer, the hydrophobic film layer and the bio-adhesive;

[0028] The first patch is provided with a loop-shaped suture, the root of the loop suture is fixed to the side of the first patch away from the biofilm layer, and the exposed pull part of the loop suture extends outward.

[0029] The second patch is provided with a barbed fixing line. One end of the barbed fixing line is a thread head fixed to the side of the second patch away from the biofilm layer, and the other end of the barbed fixing line is an exposed part extending outward.

[0030] The patches in this application are used in pairs, each with different sutures, and the paired sutures work together to connect the two patches. By adopting the above technical solution, without creating pinholes, the first and second patches are adhered to the dura mater on both sides of the wound using bio-adhesive. The first and second patches are connected by interlocking loop sutures and barbed fixation sutures. This method is simple to operate, low in cost, and stable and reliable in use. The first patch has loop sutures with exposed pull-out portions, and the second patch has barbed fixation sutures with exposed portions, facilitating the insertion of the second patch through the loop structure of the first patch during spinal endoscopy, thus closing the dura mater injury on both sides and achieving non-invasive dura mater repair.

[0031] Optionally, both the loop suture and the barbed fixing suture are absorbable sutures; the loop root of the loop suture is fixed to the center of the biofilm layer on the first patch, and the head of the barbed fixing suture is fixed to the center of the biofilm layer on the second patch.

[0032] By adopting the above technical solution, postoperative suture removal can be avoided, reducing patient pain and infection risk. The fixed position of the loop suture coil root is directly opposite the center position of the biofilm layer on the first patch, and the fixed position of the barbed suture head is directly opposite the center position of the biofilm layer on the second patch. This can evenly transmit force to the surfaces of the first and second patches, and greatly improve the stability and reliability of the connection between the two, enhance the adhesion between the patch and the dura mater, and achieve non-invasive repair of dura mater injury.

[0033] 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 each independently provided with the biofilm layer, the hydrophobic film layer and the bio-adhesive;

[0034] The first patch is provided with a ring-shaped barbed wire. The coil root of the barbed wire is fixed to the side of the first patch away from the biofilm layer, and the exposed pull part of the barbed wire extends outward.

[0035] The second patch is provided with a fixing suture, one end of which is a thread head fixed to the side of the second patch away from the biofilm layer; the other end of which is an exposed portion extending outward.

[0036] This technical solution provides another matching suture connection structure. By adopting the above technical solution, the connection between the first patch and the second patch can be achieved very conveniently and quickly.

[0037] Optionally, both the loop-type barbed suture and the fixing suture are absorbable sutures; the fixed position of the coil root of the loop-type barbed suture is directly opposite the center position of the biofilm layer on the first patch, and the fixed position of the thread head of the fixing suture is directly opposite the center position of the biofilm layer on the second patch.

[0038] By adopting the above technical solution, postoperative suture removal can be avoided, reducing patient pain and infection risk. The fixed position of the loop-type barbed suture coil root is directly opposite the center position of the biofilm layer on the first patch, and the fixed position of the suture head is directly opposite the center position of the biofilm layer on the second patch. This can evenly transmit force to the surfaces of the first and second patches, greatly improving the stability and reliability of the suture connection, enhancing the adhesion between the patch and the dura mater, and achieving non-invasive repair of dura mater injury.

[0039] Optionally, the patch substrate is made of bio-protein adhesive material, polyglycolic acid material, non-crosslinked adhesive raw material, or a synthetic material of silk fibroin and PEG.

[0040] The bio-adhesive is made of polyethylene glycol hydrogel or of fibrinogen and fibrinolysis inhibitor;

[0041] The biomembrane layer is made of decellularized dermal matrix material, cross-linked collagen membrane material, silk fibroin membrane material, or nanocellulose composite membrane material;

[0042] The hydrophobic membrane layer is made of expanded polytetrafluoroethylene membrane material, polycaprolactone nanofiber membrane material, or fluorinated polymer membrane material.

[0043] By adopting the above technical solutions, using bio-protein adhesive materials, polyglycolic acid materials, non-crosslinked adhesive raw materials, and synthetic materials of silk fibroin and PEG to make patch substrates, it is possible to ensure that the patch has suitable physical properties and biocompatibility; using polyethylene glycol hydrogel or fibrinogen and fibrinolysis inhibitors to make bio-adhesive can achieve effective adhesion between the patch and the dura mater; using decellularized dermal matrix materials, crosslinked collagen membrane materials, silk fibroin membrane materials, and nanocellulose composite membrane materials to make biomembrane layers can protect the bio-adhesive and have good tissue compatibility with the dura mater; using expanded polytetrafluoroethylene membrane materials, polycaprolactone nanofiber membrane materials, and fluorinated polymer membrane materials to make hydrophobic membrane layers can prevent water from penetrating into the bio-adhesive portion under the aqueous medium of spinal endoscopy, causing it to lose its adhesiveness.

[0044] In summary, this application includes at least one of the following beneficial technical effects:

[0045] 1. The bio-adhesive patch in this application uses bio-adhesive to bond the patch and tissue to achieve the repair of the dura mater, which will not cause pinholes and completely avoids the phenomenon of cerebrospinal fluid leakage from the pinholes.

[0046] 2. In this application, the bio-adhesive is located in the vacuum cavity between the biofilm layer and the patch substrate, which facilitates transportation and long-term storage, and the bio-adhesive is not prone to failure.

[0047] 3. In this application, a biofilm layer and a hydrophobic film layer are used to protect the bioadhesive. The hydrophobic film layer effectively prevents the liquid from coming into premature contact with the bioadhesive, which would cause the bioadhesive 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.

[0048] 4. In this application, a protrusion is provided on the patch substrate, and the release of biological adhesive can be easily achieved by squeezing with surgical instruments. The operation is simple, and it can effectively bond to the dura mater injury site in a flowing water medium environment. It can be used for non-invasive unilateral dual-channel spinal endoscopy to repair dura mater injury. Attached Figure Description

[0049] Figure 1 This is a schematic diagram of the structure of the bio-adhesive patch in this application.

[0050] Figure 2 This is a schematic diagram of the bonding process between the bio-adhesive patch and the dura mater in this application.

[0051] Figure 3 This is a frontal view structural diagram of the two bio-adhesive patches in Embodiment 1 of this application.

[0052] Figure 4 This is a schematic diagram of the back view of the two bio-adhesive patches in Embodiment 1 of this application.

[0053] Figure 5 This is a schematic diagram of the bonding process of two bio-adhesive patches in Embodiment 1 of this application.

[0054] Figure 6 This is a side view of the process of bonding two bio-adhesive patches together in Embodiment 1 of this application.

[0055] Figure 7 This is a schematic diagram of the process of two bio-adhesive patches bonding together during surgery in Embodiment 1 of this application.

[0056] Figure 8 This is a frontal view schematic diagram of the first patch and the second patch in Embodiment 2 of this application.

[0057] Figure 9 This is a schematic diagram of the back view of the first patch and the second patch in Embodiment 2 of this application.

[0058] Figure 10 This is a schematic diagram of the adhesion of the first patch and the second patch during surgery in Embodiment 2 of this application.

[0059] Figure 11 This is a frontal view schematic diagram of the first patch and the second patch in Embodiment 3 of this application.

[0060] Figure 12 This is a schematic diagram of the adhesion of the first patch and the second patch during surgery in Embodiment 3 of this application.

[0061] In the picture:

[0062] 10. Patch substrate; 11. Protrusion; 12. First part; 13. Second part; 14. First patch; 15. Second patch;

[0063] 20. Bio-adhesive section; 21. Vacuum chamber; 22. Bio-adhesive solution;

[0064] 30. Biofilm layer;

[0065] 40. Hydrophobic film layer;

[0066] 50. Loop stitching;

[0067] 60. Barbed fixing line;

[0068] 70. Ring-shaped barbed lines;

[0069] 80. Secure the sutures;

[0070] 90. Dura mater;

[0071] 100. Surgical instruments. Detailed Implementation

[0072] The following will be combined with the appendix Figure 1 -Appendix Figure 12 The technical solutions in the embodiments of the present invention are clearly and completely described herein. The described embodiments are only possible technical implementations of the present invention and not all possible implementations. Those skilled in the art can obtain other embodiments in conjunction with the embodiments of the present invention without creative effort, and these embodiments are also within the protection scope of the present invention.

[0073] Example 1

[0074] Reference Figure 1 and Figure 2 As shown, the bio-adhesive patch used for non-invasive repair of the dura mater in this application includes a patch substrate 10, a bio-adhesive portion 20, a biofilm layer 30, and a hydrophobic membrane layer 40. The biofilm layer 30 is fixed 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. Bio-adhesive 22 is injected into the vacuum cavity 21 to form the bio-adhesive portion 20. The bio-adhesive 22 can be transformed from a "liquid" to a "solid" to bond tissues. The hydrophobic membrane layer 40 is attached to the outer side of the biofilm layer 30.

[0075] In this embodiment, the patch substrate 10 can be made of bio-protein adhesive material, polyglycolic acid material, non-crosslinked adhesive raw material, or a synthetic material of silk fibroin and PEG, which can ensure that the patch has suitable physical properties and biocompatibility; the bio-adhesive 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 biofilm layer 30 can be made of decellularized dermal matrix material, crosslinked collagen membrane material, silk fibroin membrane material, or nanocellulose composite membrane material, and the biofilm 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 bio-adhesive part within 20 minutes under the aqueous medium of spinal endoscopy, causing it to lose its adhesiveness.

[0076] Reference Figure 1As shown, in this embodiment, the patch substrate 10 has protrusions 11 on the side facing the biofilm layer 30 for piercing the biofilm layer 30 and the hydrophobic membrane layer 40. When the surgical instrument 100 presses the patch substrate 10, the protrusions 11 ensure that the biofilm layer 30 and the hydrophobic membrane layer 40 rupture instantaneously, thereby allowing the bio-adhesive 22 to quickly contact the dura mater 90 portion and complete effective adhesion. Furthermore, in this application, 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 smaller planar area of ​​the biofilm layer 30 compared to the patch substrate 10 and its central location allow the bio-adhesive 22 to have a more concentrated and effective application area during patch adhesion, preventing overflow. The shape of the patch substrate 10 can be cut or pre-designed according to the wound condition of the dura mater 90; for example, the patch substrate 10 can be designed as a cuttable rectangle with a planar length and width of 5cm x 5cm, 5cm x 10cm, or 10cm x 10cm and a thickness of 1mm. The biofilm layer 30 can be rectangular, circular, or elliptical; the bioadhesive part 20 can be a circle with a planar radius of 1mm and a thickness of 0.5mm; the protrusion part 11 has a "+" shaped protrusion structure, with the center of the protrusion part 11 directly opposite the center of the biofilm layer 30. The "+" shaped protrusion structure of the protrusion part 11 can more accurately and quickly pierce the biofilm layer 30 and the hydrophobic membrane layer 40, and create a larger opening, facilitating the rapid flow of bioadhesive 22 for bonding the patch substrate 10 to the dura mater 90. The outer edges and ends of the protrusion part 11 are smooth to prevent secondary damage to the dura mater 90 during the pressurization process.

[0077] See Figure 3 and Figure 4 As shown, in this embodiment, the patch substrate 10 includes a first part 12 and a second part 13 connected together; the first part 12 is circular, elliptical, or rectangular, and the second part 13 is connected to one side of the first part 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 fixed together; each of the first part 12 and the second part 13 is independently provided with a biofilm layer 30, a hydrophobic film layer 40, and a bio-adhesive 22. Further, one end of the second part 13 is fixed 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.

[0078] When using, refer to Figure 5 , Figure 6 and Figure 7As shown, two bioadhesive patches can be used together. The first part 12 of one bioadhesive patch is adhered to one side of the dura mater 90 wound, and the first part 12 of the other bioadhesive patch is adhered to the other side of the dura mater 90 wound. The second parts 13 of the two bioadhesive patches are adhered together. In this application, the connection between the first part 12 of the patch substrate 10 and the dura mater 90, as well as the connection between the second parts 13 of the two patch substrates 10, are achieved by squeezing and piercing the biofilm layer 30 and the hydrophobic membrane layer 40 with the surgical instrument 100, and then using the flowing bioadhesive 22 for adhesion. This avoids the formation of pinholes and facilitates surgical manipulation. In the above structure, the two different patch substrates 10 can be easily adhered together using a clamping tool. In this application, two patches can be used to repair complex or large dura mater 90 injuries in a flowing water medium environment, meeting the requirements for the use of unilateral dual-channel spinal endoscopy technology, reducing the trauma of dura mater 90 injury repair surgery, and shortening the postoperative recovery time.

[0079] In this embodiment, the patch substrate 10, bio-adhesive 22, biofilm layer 30, and hydrophobic film layer 40 are all existing materials that can be purchased directly from external sources or prepared according to existing technologies.

[0080] For example, the patch substrate 10 can use the substrate described in Chinese patent document CN201921326114X (publication number: CN211068233U; publication date: 2020-07-24); the patch substrate 10 can also be a synthetic patch developed and produced by Beijing Shunxing Biotechnology Co., Ltd., a subsidiary of Beijing Kangpait Medical, suitable for the repair of extra-abdominal inguinal and femoral hernias. When the patch substrate 10 is made of biological protein glue, its source includes decellularized animal tissues (such as the submucosa of porcine small intestine, dermis, and pericardium).

[0081] The bio-adhesive 22 can be the bio-adhesive described in the Chinese patent application document CN2025101497611 (publication number: CN119909220A; publication date: 2025-05-02); the bio-adhesive 22 can also be the Kangpaite brand endoscopic medical adhesive produced by Beijing Kangpaite Medical Device Co., Ltd., which is a colorless or slightly yellow transparent liquid that can begin to cure in 3 to 5 seconds when used.

[0082] The biomembrane layer 30 can use the biomembrane material described in Chinese patent application document No. 2021106098130 (Publication No.: CN113304321A; Publication Date: 2021-08-27). Alternatively, the biomembrane layer 30 can be directly purchased from the Newray nerve repair membrane produced by Shandong Junxiu Biotechnology Co., Ltd.; its material is derived from the extracellular matrix (decellularized matrix) of pig peripheral nerve cells, with a thickness of less than 100 micrometers, forming a transparent or translucent film; it prepares animal nerve tissue into a membrane suitable for human nerve repair, retaining the natural extracellular matrix structure and bioactive factors.

[0083] The hydrophobic membrane layer 40 can be prepared using the polytetrafluoroethylene membrane preparation method in Chinese patent application document CN2017107779091 (publication number: CN107837691B; publication date: 2020-02-14) as the hydrophobic membrane layer 40 in this application.

[0084] The implementation principle is as follows: When performing non-invasive dura mater repair using two L-shaped bio-adhesive patches, under spinal endoscopy, one bio-adhesive patch is quickly pushed onto the surface of the dura mater 90 on the side of the dura mater 90 injury using a surgical instrument 100 within the operating channel and pressed down. The first part 12 of this bio-adhesive patch adheres to the surface of the dura mater 90. The first part 12 of the other bio-adhesive patch is then adhered to the surface of the dura mater 90 on the other side of the dura mater 90 injury in the same manner. Then, under spinal endoscopy, the second parts 13 of the two bio-adhesive patches are aligned and pressed down using the surgical instrument 100, so that the two are firmly bonded together using bio-adhesive 22, thereby achieving unilateral dual-channel spinal endoscopy for non-invasive repair of the dura mater 90.

[0085] In this application, the bio-adhesive 22 is located within the vacuum cavity 21 between the biofilm layer 30 and the patch substrate 10, preventing premature solidification and adhesion, thus facilitating transportation and storage. The biofilm layer 30 protects the bio-adhesive 22, exhibiting good tissue compatibility and preventing biological or chemical reactions with the dura mater 90. The hydrophobic membrane layer 40 effectively prevents water from penetrating to the bio-adhesive 22 in a water-based environment within the spine, thus preventing loss of adhesion. During use, under a water-based environment within a spinal endoscope, effective pressure is applied using the surgical instrument 100. The protrusions 11 on the patch substrate 10 easily puncture the biofilm layer 30 and the hydrophobic membrane layer 40. After rupture, the bio-adhesive 22 is extruded, allowing the patch substrate 10 to effectively adhere to the dura mater 90 or another patch substrate 10, thereby achieving wound repair of the dura mater 90.

[0086] The bio-adhesive patch in this application repairs the dura mater 90 by bonding the patch and tissue with bio-adhesive 22, eliminating pinholes and completely preventing cerebrospinal fluid leakage. Furthermore, the bio-adhesive 22 is located within the vacuum cavity 21 between the biofilm layer 30 and the patch substrate 10, facilitating transportation and long-term storage. The bio-adhesive 22 is less prone to failure. The biofilm layer 30 and the hydrophobic film layer 40 protect the bio-adhesive 22, preventing premature contact with liquids that could lead to coagulation and adhesion failure. The biofilm layer 30 and the dura mater 90 exhibit good tissue compatibility and will not cause abnormal reactions. The bio-adhesive 22 can be easily released by squeezing with a surgical instrument 100 using a protruding portion 11, simplifying the operation. It can effectively bond to the damaged area of ​​the dura mater 90 in a flowing water medium environment and can be used for non-invasive unilateral dual-channel spinal endoscopy to repair dura mater 90 injuries.

[0087] This application innovatively develops a bio-adhesive patch for effective and safe repair of the dura mater 90 in an aqueous medium, overcoming the technical bottleneck of traditional repair methods in non-invasive procedures. Addressing clinical pain points such as difficulty in closure, insufficient stability, and the risk of secondary injury in dura mater 90 repair during spinal endoscopic surgery, the technical solution in this application constructs a modular repair system adaptable to different anatomical locations and injury morphologies through synergistic innovation in composite biomaterial engineering design and clinical spinal endoscopy technology. This type of bio-adhesive patch can effectively adhere to the dura mater 90 injury site in a flowing aqueous environment, while also exhibiting good biocompatibility with the dura mater 90 tissue itself, thus achieving the goal of non-invasive dura mater 90 repair.

[0088] Example 2

[0089] Reference Figure 8 and Figure 9As shown, this embodiment is largely 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; a biofilm layer 30, a hydrophobic film layer 40 and a bio-adhesive 22 are independently provided on the first patch 14 and the second patch 15; a ring-shaped loop suture 50 is provided on the first patch 14, the root of the loop suture 50 is fixed to the side of the first patch 14 away from the biofilm layer 30, and the exposed pull part of the loop suture 50 extends outward; a barbed fixing line 60 is provided on the second patch 15, one end of the barbed fixing line 60 is the head of the line fixed to the side of the second patch 15 away from the biofilm layer 30, and the other end of the barbed fixing line 60 is the exposed part extending outward. Furthermore, both the loop suture 50 and the barbed fixing suture 60 are absorbable sutures; the loop root of the loop suture 50 is fixed to the center of the biofilm layer 30 on the first patch 14, and the head of the barbed fixing suture 60 is fixed to the center of the biofilm layer 30 on the second patch 15.

[0090] The implementation principle is as follows: The patches in this application are used in pairs, each with different sutures, and the paired sutures cooperate to connect the two patches. Specifically, the bio-adhesive patch in this application is a suture-embedded bio-adhesive patch, combined with... Figure 10 As shown, when using this suture-attached bio-adhesive patch for non-invasive dura mater repair, the first patch 14 is placed on the surface of the dura mater 90 on the side of the dura mater 90 injury using a surgical instrument 100 within the operating channel of the spinal endoscope, and pressed to adhere the first patch 14 to the surface of the dura mater 90. Then, using the same surgical instrument 100, the second patch 15 is passed through the loop structure of the loop suture 50 on the first patch 14 within the operating channel of the spinal endoscope, and pushed to the surface of the dura mater 90 on the other side of the dura mater 90 injury. Pressing is performed in an aqueous medium to adhere the second patch 15 to the surface of the dura mater 90. Then, the exposed portion of the barbed fixing suture 60 on the second patch 15 is pulled taut externally, and the exposed pull portion of the loop suture 50 on the first patch 14 is pulled to close both sides of the dura mater 90 injury. After closure, traction is continued, and excess sutures are removed with scissors.

[0091] In this embodiment, the technical solution, without creating pinholes, involves bonding the first patch 14 and the second patch 15 to the dura mater 90 on both sides of the wound using bio-adhesive 22. The first patch 14 and the second patch 15 are connected by interlocking loop sutures 50 and barbed fixation sutures 60. This method is simple to operate, low in cost, and stable and reliable in use. The first patch 14 features loop sutures 50 with exposed pull-out portions, while the second patch 15 features barbed fixation sutures 60 with exposed portions. This facilitates the insertion of the second patch 15 through the loop structure of the loop sutures 50 on the first patch 14 during spinal endoscopy, allowing the damaged sides of the dura mater 90 to close, thus achieving non-invasive dura mater 90 repair. In this application, both the loop suture 50 and the barbed fixation suture 60 are absorbable sutures, which can avoid postoperative suture removal and reduce patient pain and infection risk. The loop root of the loop suture 50 is fixed to the center of the biofilm layer 30 on the first patch 14, and the head of the barbed fixation suture 60 is fixed to the center of the biofilm layer 30 on the second patch 15. This 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 adhesion between the patch and the dura mater 90, and achieve non-invasive repair of dura mater 90 damage.

[0092] Example 3

[0093] Reference Figure 11 and Figure 12 As shown, this embodiment is largely the same as Embodiment 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 a loop-shaped barbed suture 70, the coil root of which is fixed to the side of the first patch 14 away from the biofilm layer 30, and the exposed pull portion of the loop-shaped barbed suture 70 extends outward; the second patch 15 is provided with a fixing suture 80, one end of which is the thread head fixed to the side of the second patch 15 away from the biofilm layer 30; the other end of which is the exposed portion extending outward. In this embodiment, both the loop-shaped barbed suture 70 and the fixing suture 80 are absorbable sutures; the fixed position of the coil root of the loop-shaped barbed suture 70 is directly opposite the center position of the biofilm layer 30 on the first patch 14, and the fixed position of the thread head of the fixing suture 80 is directly opposite the center position of the biofilm layer 30 on the second patch 15.

[0094] This embodiment provides another matching suture connection structure, which can also conveniently and quickly connect the first patch 14 and the second patch 15. Its implementation principle and technical effect are basically the same as those in embodiment 2, and will not be repeated here.

[0095] The embodiments described in this specific implementation are 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, all equivalent changes made to the structure, shape, and principle of this application should be covered within the scope of protection of this application.

Claims

1. A bio-adhesive patch for non-invasive repair of the dura mater, comprising a patch substrate (10), characterized in that, A biofilm layer (30) with good tissue compatibility with the dura mater (90) is provided on one side of the patch substrate (10). A hydrophobic membrane layer (40) is provided on the outer side 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). Bioadhesive (22) is provided in the vacuum cavity (21). The patch substrate (10) has protrusions (11) on the side facing the biofilm layer (30) for piercing the biofilm layer (30) and the hydrophobic membrane layer (40).

2. The bio-glue patch for non-invasive repair of the 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 protruding part (11) is a cross-shaped protruding structure.

3. The bio-glue patch for non-invasive repair of the dura mater according to claim 2, characterized in that, The outer edge and end of the protrusion (11) are both smooth.

4. The bio-adhesive patch for non-invasive repair of the dura mater according to claim 1, 2, or 3, characterized in that, The patch substrate (10) includes a first part (12) and a second part (13) connected to each other; the first part (12) is circular, elliptical or rectangular, and the second part (13) is connected to one side of the first part (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 fixed together; The first part (12) and the second part (13) are each independently provided with the biofilm layer (30), the hydrophobic membrane layer (40) and the bioglue (22).

5. The bio-adhesive patch for non-invasive repair of the dura mater according to claim 4, characterized in that, One end of the second part (13) is fixed 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 bio-glue patch for non-invasive repair of the dura mater according to claim 1, 2, or 3, characterized in that, The patch substrate (10) 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 each independently provided with the biofilm layer (30), the hydrophobic film layer (40) and the bio-adhesive (22); The first patch (14) is provided with a ring-shaped loop suture (50), the root of the loop suture (50) is fixed to the side of the first patch (14) away from the biofilm layer (30), and the exposed pull part of the loop 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 on the side of the second patch (15) away from the biofilm layer (30), and the other end of the barbed fixing line (60) is an exposed part extending outward.

7. The bio-adhesive patch for non-invasive repair of the dura mater according to claim 6, characterized in that, Both the loop suture (50) and the barbed fixing suture (60) are absorbable sutures; the loop root of the loop suture (50) is fixed to the center of the biofilm layer (30) on the first patch (14), and the head of the barbed fixing suture (60) is fixed to the center of the biofilm layer (30) on the second patch (15).

8. The bio-glue patch for non-invasive repair of the dura mater according to claim 1, 2, or 3, characterized in that, The patch substrate (10) 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 each independently provided with the biofilm layer (30), the hydrophobic film layer (40) and the bio-adhesive (22); The first patch (14) is provided with a ring-shaped barbed wire (70), the coil root of the ring-shaped barbed wire (70) is fixed to the side of the first patch (14) away from the biofilm layer (30), and the exposed pull part of the ring-shaped barbed wire (70) extends outward. The second patch (15) is provided with a fixing suture (80), one end of which is a thread head fixed on the side of the second patch (15) away from the biofilm layer (30); the other end of which is an exposed part extending outward.

9. The bio-glue patch for non-invasive repair of the dura mater according to claim 8, characterized in that, Both the loop-type barbed suture (70) and the fixing suture (80) are absorbable sutures; the fixed position of the coil root of the loop-type barbed suture (70) is directly 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 fixing suture (80) is directly opposite to the center position of the biofilm layer (30) on the second patch (15).

10. The bio-adhesive patch for non-invasive repair of the dura mater according to claim 1, characterized in that, The patch substrate (10) is made of bio-protein adhesive material, polyglycolic acid material, non-crosslinked adhesive raw material, or a synthetic material of silk fibroin and PEG. The bio-adhesive (22) is made of polyethylene glycol hydrogel or of fibrinogen and fibrinolysis inhibitor; The biomembrane layer (30) is made of decellularized 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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