Transnasal nerve skull base repair device, skull base repair membrane and method of using the device

Abstract

The present invention relates to a transnasal nerve skull base repair device, a skull base repair membrane and a method for using the device, including a first repair membrane component for repairing a liliequist membrane leak, and a second repair membrane component for repairing a dura mater leak. The transnasal nerve skull base repair device, the skull base repair membrane and a method for using the device, through the coordinated use of a fusible biomembrane, a non-fusible biomembrane, a support, a hemostatic gauze and a fixed airbag, make the technical solution of the present application compact in structure, strong in clinical practicality and significant in effect, adopt a multi-layer artificial biomembrane, assist with artificial support and fixing materials, successfully achieve skull base repair, prevent the occurrence of cerebrospinal fluid leakage after transnasal nerve endoscopic surgery, reduce the risk of intracranial infection, reduce the possibility of endangering the patient's life, improve the patient's quality of life and improve the prognosis; moreover, artificial materials are used in the repair process of the method.

Description

Technical Field

[0001] The present invention relates to the technical field of skull base repair, and in particular to a transnasal skull base repair device, a skull base repair membrane and a method for using the device. Background Art

[0002] Transnasal neuroendoscopic surgery has the advantages of wide surgical viewing angle, high illumination intensity, strong direct vision, and low trauma, so it is widely used in the resection and treatment of intracranial sellar space-occupying lesions (such as pituitary adenoma, craniopharyngioma, Rathke cyst, meningioma, etc.). Usually, the implementation of transnasal neuroendoscopic surgery will cause varying degrees of damage to the skull base bone, dura mater, and liliequist membrane, thereby increasing the postoperative complication of cerebrospinal fluid leakage; therefore, postoperative transnasal neuroendoscopic skull base repair has important practical application value in preventing the occurrence of cerebrospinal fluid leakage.

[0003] At present, one of the conventional methods for postoperative transnasal neuroendoscopic skull base repair for the above situation is to use autologous tissue to repair the skull base. Commonly used autologous tissues include nasal mucosal flap, fascia lata, anterior rectus sheath, fat, muscle, etc. This repair method requires the use of the patient's own tissue [Chinese Journal of Practical Neurological Diseases, Vol. 22, No. 15, pp. 1689-1693, 2019, Clinical Analysis of Neuroendoscopic Treatment of Traumatic Cerebrospinal Fluid Rhinorrhoea], but this method will damage the normal anatomical structure of the relevant parts, thereby causing olfactory damage, loss of nasal defense function, dyspnea, loss of skin sensation, wound infection, poor wound healing, muscle injury, muscle pain, long-term poor wound healing leading to limb movement disorders, deep vein thrombosis, etc., and affects the judgment of whether the sellar region lesions recur after surgery (imaging causes confusion).

[0004] In recent years, with the development and maturity of artificial dura mater technology, the use of autologous tissue combined with artificial dura mater under neuroendoscopy has also become one of the commonly used methods for repairing the skull base [Journal of Clinical Neurosurgery, Vol. 13, No. 2, 2016, pp. 86-92, Discussion on the causes and treatment of failure of cerebrospinal fluid leakage repair during transsphenoidal pituitary tumor surgery under neuroendoscopy], but this method still has the disadvantage of damaging autologous tissue.

[0005] It can be seen that it is urgently needed in the current field to design a new transnasal neuroendoscopic skull base repair device to solve the above problems. Summary of the invention

[0006] In view of this, an object of the present invention is to provide a transnasal neuroskull base repair device, a skull base repair membrane and a method of using the device, so as to solve the problem that the prior art is inconvenient for postoperative transnasal neuroskull base repair.

[0007] The present invention is achieved through the following technical solutions:

[0008] One of the present inventions:

[0009] The transnasal neuroskull base repair device comprises a first repair membrane component for repairing a liliequist membrane leak and a second repair membrane component for repairing a dura mater leak.

[0010] Furthermore, the first repair membrane component and the second repair membrane component both include a fusible biomembrane and a non-fusible biomembrane used in cooperation with the fusible biomembrane.

[0011] Furthermore, the first repair membrane assembly also includes a support member.

[0012] Furthermore, the second repair membrane component also includes hemostatic gauze.

[0013] Furthermore, the second repair membrane assembly also includes a fixing airbag for fixing the hemostatic gauze.

[0014] The second of the present invention:

[0015] The skull base repair membrane refers to the transnasal nerve skull base repair device described in any one of claims 2 to 5 above, wherein the fusible biomembrane is a xenogeneic acellular dermal matrix, and the non-fusible biomembrane is a type B dura mater repair material.

[0016] The third invention:

[0017] The skull base repair membrane refers to the transnasal nerve skull base repair device described in claim 3 above, wherein the support member is a gelatin sponge.

[0018] The fourth aspect of the present invention:

[0019] The method for using the repair device according to any one of claims 1 to 5 comprises the following specific steps:

[0020] 1).Material production;

[0021] I. Fabrication of fusible biofilms;

[0022] II. Production of non-fusible biofilms;

[0023] 2). Repair the leakage of liliequist membrane;

[0024] I. placing the fusible biofilm of the first repair membrane assembly at the repair site;

[0025] II. placing the support member at the location to be used, and supporting and fixing the fusible biofilm of the first repair membrane assembly;

[0026] III. placing the non-fusible biofilm of the first repair membrane assembly at the place of use, close to the support;

[0027] 3). Repair the dura mater leak;

[0028] I. placing the fusible biofilm of the second repair membrane assembly at the repair site;

[0029] II. Place the non-fusible biofilm of the second repair membrane assembly at the place of use, close to the adjacent fusible biofilm and cover it

[0030] Furthermore, in step 3, the hemostatic gauze is used to support and limit the non-fusible biomembrane at the second repair membrane assembly.

[0031] Furthermore, in step 3, the air bag is further fixed to the hemostatic gauze.

[0032] The beneficial effects of the present invention are:

[0033] The transnasal neuroskull base repair device, skull base repair membrane and the method for using the device, through the coordinated use of a fusible biomembrane, a non-fusible biomembrane, a support, a hemostatic gauze and a fixed airbag, make the technical solution of the present application compact in structure, strong in clinical practicality and significant in effect. The multi-layer artificial biomembrane is used to assist in artificial support and fixation materials, and the skull base repair is successfully achieved, preventing the occurrence of cerebrospinal fluid leakage as a complication after transnasal neuroendoscopic surgery, reducing the risk of intracranial infection, reducing the possibility of endangering the patient's life, improving the patient's quality of life and improving the prognosis; moreover, the method uses artificial materials during the repair process, will not damage the normal anatomical structure of the relevant parts, and thus will not cause complications such as loss of smell and limb movement disorders; more importantly, the method does not use autologous tissue to repair the skull base, and will not affect the imaging interpretation results during the follow-up process, thereby improving the accuracy of the doctor's judgment on the removal of the patient's sellar region lesions and whether they recur.

[0034] Other advantages, objectives and features of the present invention will be described in the following description to some extent, and to some extent, will be obvious to those skilled in the art based on the following examination and study, or can be taught from the practice of the present invention. The objectives and other advantages of the present invention can be realized and obtained through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 This is a schematic diagram of a first repair membrane assembly of the present invention;

[0036] Figure 2 is a schematic diagram of a second repair membrane assembly of the present invention;

[0037] Figure 3 The figure is a schematic diagram of the use process of the repair device of the present invention.

[0038] In the figure: 1. First repair membrane component; 2. Fusible biofilm; 3. Non-fusible biofilm; 4. Support; 5. Second repair membrane component; 6. Hemostatic gauze; 7. Fixed airbag. DETAILED DESCRIPTION

[0039] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0040] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0041] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0042] In the above description of the present invention, it should be noted that the terms "one side", "the other side", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is usually placed when in use, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0043] In addition, the term "same" does not mean that the parts must be absolutely the same, but slight differences are allowed. The term "vertical" only means that the positional relationship between the parts is more vertical than "parallel", and does not mean that the structure must be completely vertical, but can be slightly tilted.

[0044] One of the present inventions:

[0045] See also Figure 1-2 , the present invention provides a technical solution: a transnasal neuroskull base repair device, comprising a first repair membrane component 1 for repairing a liliequist membrane leak, and a second repair membrane component 5 for repairing a dura mater leak;

[0046] The first repair membrane component 1 and the second repair membrane component 5 both include a fusible biomembrane 2 and a non-fusible biomembrane 3 used in conjunction with the fusible biomembrane 2. The fusible biomembrane of the first repair membrane component is placed at the bottom of the third ventricle, with its inner side close to and covering the liliequist membrane leakage at the bottom of the third ventricle, and is used to grow and fuse with the bottom of the third ventricle to prevent a large amount of high-flow cerebrospinal fluid from leaking into the interpeduncular cistern due to the impact of cerebrospinal fluid.

[0047] The first repair membrane assembly 1 also includes a support member 4. After the fusible biomembrane of the first repair membrane assembly is placed, the support member is placed in the tumor cavity, and its inner side is close to and supports the fusible biomembrane of the first repair membrane assembly, so that the fusible biomembrane is further close to and covers the leakage of the liliequist membrane at the bottom of the third ventricle, and further prevents a large amount of high-flow cerebrospinal fluid from leaking into the interpeduncular pool. The filling amount of the support member is about 80%-85% of the tumor cavity space, and is used to support the adjacent fusible biomembrane without compressing the optic nerve in the sellar region and the aqueduct at the bottom of the third ventricle (gelatin sponge swells when it meets water. If the filling amount is too large, the gelatin sponge will bend the fusible biomembrane toward the third ventricle, thereby blocking the aqueduct at the bottom of the third ventricle, resulting in abnormal circulation of cerebrospinal fluid);

[0048] After the support and the fusible biomembrane are placed, the non-fusible biomembrane of the first repair component is placed under the dura mater, with the inner side of the biomembrane close to the support and the outer side close to and covering the dura mater leak, so as to reduce the leakage of a small amount of cerebrospinal fluid from the interpeduncular cistern to the sphenoid sinus area;

[0049] After the first repair membrane component is placed, the second repair component is taken out and put into use. First, the fusible biomembrane of the second repair membrane component is placed outside the dura mater, with its inner side closely attached to and covering the dura mater leak, so as to be fused with the dura mater growth to form a seal, thereby preventing a small amount of cerebrospinal fluid from the interpeduncular cistern from leaking into the sphenoid sinus area. Then, the non-fusible biomembrane of the second repair membrane component is placed outside the dura mater, with its inner side closely attached to and covering the fusible biomembrane, thereby preventing the fusible biomembrane from sliding, thereby further reducing a small amount of cerebrospinal fluid from the interpeduncular cistern from leaking into the sphenoid sinus area.

[0050] The second repair membrane component 5 also includes a hemostatic gauze 6. After the fusible biofilm and the non-fusible biofilm are placed, the hemostatic gauze 6 is placed in the sphenoid sinus area and fills the sphenoid sinus. The inner side of the hemostatic gauze 6 is close to and presses the non-fusible biofilm of the second repair membrane component to prevent the non-fusible biofilm from sliding.

[0051] The second repair membrane assembly 5 also includes a fixing airbag 7 for fixing the hemostatic gauze 6. The fixing airbag 7 is placed in the nasal cavity, and its periphery is close to the nasal cavity, and its inner side is close to and supports the hemostatic gauze, so as to prevent the hemostatic gauze from shifting.

[0052] It should be further explained here that all the above-mentioned operation steps need to be performed under the guidance of a neuroendoscope. As for the operation method and usage principle of the inner diameter of the nerve, they are existing technologies in this field. Based on mastering the existing technologies, technical personnel in this field can implement the above-mentioned technical solutions without creative labor and thinking.

[0053] The second of the present invention:

[0054] The skull base repair membrane, citing any of the above-mentioned transnasal nerve skull base repair devices 2-5, the fusible biomembrane 2 is a heterogeneous acellular dermal matrix, and the non-fusible biomembrane 3 is a type B dura mater repair material. The fusible biomembrane is derived from bovine skin tissue, and is degreased, decellularized, and deproteinized by chemical methods, and is prepared by freeze-drying technology to retain the natural microstructure of collagen. The non-fusible biomembrane is derived from bovine pericardial tissue, and is modified by epoxy fixation, multi-directional antigen removal, protein molecule modification toughening, adhesion, and surface functionalization treatment enriched with growth factors, and has the function of in situ recruiting stem cells and growth factors released and transported to the implantation site by the self-repair mechanism, inducing tissue regeneration, and finally regenerating the defective dura mater tissue. .

[0055] The third invention:

[0056] The skull base repair membrane is based on the transnasal nerve skull base repair device of claim 3, and the support member 4 is a gelatin sponge.

[0057] The fourth aspect of the present invention:

[0058] See also Figure 3 , the method of using the repair device, the specific steps are as follows,

[0059] 1).Material production;

[0060] I. Preparation of fusible biofilm 2, which is derived from bovine skin tissue, is degreased, decellularized, and deproteinized by chemical methods, and is freeze-dried to prepare an absorbable xenogeneic acellular dermal matrix that retains the natural microstructure of collagen;

[0061] II. The preparation of non-fusible biomembrane 3 is derived from bovine pericardial tissue, which is modified by epoxy fixation, multi-directional antigen removal, protein molecule modification and toughening, adhesion and surface functionalization for enriching growth factors, etc. It has the function of in situ recruiting stem cells and growth factors released and transported to the implantation site by the self-repair mechanism, inducing tissue regeneration, and finally regenerating the defective dura mater tissue;

[0062] 2). Repair the leakage of liliequist membrane;

[0063] I. placing the fusible biofilm 2 of the first repair membrane assembly 1 at the repair site, at the bottom of the third ventricle, with its inner side close to and covering the leakage of the liliequist membrane at the bottom of the third ventricle, so as to grow and fuse with the bottom of the third ventricle, and prevent a large amount of high-flow cerebrospinal fluid from leaking into the interpeduncular cistern due to the impact of cerebrospinal fluid;

[0064] II. Place the support member 4 at the place to be used, support and fix the fusible biomembrane 2 of the first repair membrane component 1, place the support member in the tumor cavity, and its inner side is close to and supports the fusible biomembrane of the first repair membrane component, so that the fusible biomembrane is further close to and covers the leakage of the liliequist membrane at the bottom of the third ventricle, and further prevents a large amount of high-flow cerebrospinal fluid from leaking into the interpeduncular pool. The filling amount of the support member is about 80%-85% of the tumor cavity space, which is used to support the fusible biomembrane and does not compress the optic nerve in the sellar region and the aqueduct at the bottom of the third ventricle. (Gelatin sponge expands when it comes into contact with water. If the filling amount is too large, the gelatin sponge will bend the fusible biomembrane toward the third ventricle, thereby blocking the aqueduct at the bottom of the third ventricle, resulting in the inability of cerebrospinal fluid to circulate normally);

[0065] III. Place the non-fusible biofilm 3 of the first repair membrane assembly 1 at the place of use, close to the support 4, and placed under the dura mater, with its inner side close to the support and its outer side close to and covering the dura mater leak, to reduce the leakage of a small amount of cerebrospinal fluid from the interpeduncular cistern to the sphenoid sinus area;

[0066] 3). Repair the dura mater leak;

[0067] I. placing the fusible biomembrane 2 of the second repair membrane assembly 5 at the repair site, outside the dura mater, with its inner side closely attached to and covering the dura mater leak, for fusing with the dura mater growth to form a seal, and preventing a small amount of cerebrospinal fluid from leaking from the interpeduncular cistern to the sphenoid sinus area;

[0068] II. Place the non-fusible biomembrane 3 of the second repair membrane component 5 at the place of use, close to and covering the adjacent fusible biomembrane, and place it outside the dura mater, with its inner side close to and covering the adjacent fusible biomembrane 4, to prevent the fusible biomembrane from sliding and further reduce the leakage of a small amount of cerebrospinal fluid from the interpeduncular cistern to the sphenoid sinus area.

[0069] In this embodiment: In step 3, the hemostatic gauze 6 is used to support and limit the non-fusible biomembrane 3 at the second repair membrane component 5. The hemostatic gauze 6 is placed in the sphenoid sinus area and fills the sphenoid sinus. Its inner side is close to and presses the non-fusible biomembrane 5 of the second repair membrane component to prevent the non-fusible biomembrane 5 from sliding.

[0070] In this embodiment: in step 3, the air bag is further used to fix the hemostatic gauze 6, and the fixed air bag 7 is placed in the nasal cavity, with its surroundings close to the nasal cavity and its inner side close to and supporting the hemostatic gauze 6, so as to prevent the hemostatic gauze 6 from shifting.

[0071] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution of the present invention, which should be included in the scope of the claims of the present invention.

Claims

1. Transnasal nerve skull base repair device, characterized by: It comprises a first repair membrane component (1) for repairing a liliequist membrane leak, and a second repair membrane component (5) for repairing a dura mater leak; The first repair membrane component (1) and the second repair membrane component (5) both include a fusible biofilm (2) and a non-fusible biofilm (3) used in conjunction with the fusible biofilm (2); The first repair membrane assembly (1) also includes a support member (4); The second repair membrane component (5) further includes a hemostatic gauze (6); The fusible biomembrane of the first repair membrane assembly is placed at the bottom of the third ventricle, with its inner side close to and covering the liliequist membrane leak at the bottom of the third ventricle, and is used for growing and fusing with the bottom of the third ventricle; After the fusible biomembrane of the first repair membrane component is placed, the support is placed in the tumor cavity, the inner side of which is close to and supports the fusible biomembrane of the first repair membrane component, and the fusible biomembrane is further close to and covers the liliequist membrane leak at the bottom of the third ventricle; The support fills 80%-85% of the tumor cavity space; After the support and the fusible biomembrane are placed, the non-fusible biomembrane of the first repair component is placed under the dura mater, with the inner side of the biomembrane close to the support and the outer side close to and covering the dura mater leak; After the first repair membrane component is placed, the second repair component is taken out and put into use. First, the fusible biofilm of the second repair component is placed outside the dura mater, with its inner side closely attached to and covering the dura mater leak; The non-fusible biomembrane of the second repair membrane assembly is then placed outside the dura mater, with its inner side closely attached to and covering the fusible biomembrane; The supporting member (4) is a gelatin sponge.

2. The transnasal neuroskull base repair device according to claim 1, characterized in that: The second repair membrane component (5) further comprises a fixing air bag (7) for fixing the hemostatic gauze (6).

3. The transnasal neuroskull base repair device according to claim 1 or 2, characterized in that: The fusible biomembrane (2) is a xenogeneic acellular dermal matrix, and the non-fusible biomembrane (3) is a type B dura mater repair material.

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