A skull base defect repairing device with adjusting function

Abstract

This utility model discloses a skull base defect repair device with adjustable function, including a card body. The front side of the card body is convex, and the rear side is concave. A clamping part is provided at the center of the front side of the convex side. The clamping part is arranged in an "I" shape. With the card body and clamping part provided, compared with other rigid reconstruction materials, this invention uses β-tricalcium phosphate material that can absorb human bone. It is made by mechanical processing or 3D printing technology. It has good biodegradability, biocompatibility, and non-toxicity. It can be used as an ideal bone substitute material for rigid reconstruction. In addition, this application also has the advantages of being ultra-thin, having stable clamping and good sealing effect, which can greatly reduce the occurrence of complications such as rejection reaction, postoperative cerebrospinal fluid leakage, postoperative brain tissue protrusion, and intracranial infection.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a skull base defect repair device with adjustable function. Background Technology

[0002] With the rapid development of medical technology, neuroendoscopic surgery has gradually become the preferred alternative to craniotomy due to its advantages such as minimal invasiveness, clear visualization, and preservation of facial appearance. It is widely used in surgeries for diseases such as pituitary adenomas and craniopharyngiomas in the sellar region, significantly improving surgical efficiency and accelerating postoperative recovery. However, such surgeries often require drilling into the sellar bone at the skull base, increasing the risk of postoperative complications such as repair site damage, cerebrospinal fluid leakage, and postoperative brain tissue protrusion leading to intracranial infection. Therefore, stable sellar floor reconstruction is necessary. Sellar floor reconstruction after transnasal surgery typically uses methods such as gelatin sponge or artificial dura mater for packing, biological protein glue for repair, and autologous nasal septum mucosal flaps or free tissue flaps for coverage. These materials are mostly soft and difficult to handle during intraoperative repair, often requiring significant time for packing. Furthermore, postoperative increases in intracranial pressure (such as from forceful coughing or sneezing) can damage the reconstruction material, potentially leading to cerebrospinal fluid leakage and requiring secondary surgery. This also significantly increases the risk of intracranial infection. Meanwhile, some have used rigid materials for repair, such as titanium and PEEK. However, titanium is difficult to trim, easily injures surrounding tissue, and is difficult to remove if a second surgery is needed; PEEK is expensive and cannot be degraded or absorbed by human tissue. With the current advancements in neuroendoscopic technology, these materials are no longer suitable for skull base repair.

[0003] β-Tricalcium phosphate (β-TPP) possesses excellent biodegradability, biocompatibility, and non-toxicity. When implanted in the human body, the degraded calcium and phosphorus can enter the circulatory system to form new bone. Therefore, it has become a key research focus for scholars worldwide as an ideal bone replacement material. This invention discloses a rigid absorbable skull base reconstruction patch made from β-TPP material, taking into account the size of the skull base defect after transnasal craniopharyngioma surgery.

[0004] Patent number CNCN202011190122.3 discloses a resin material, preparation method, and application for repairing skull defects after transnasal skull base surgery. Utilizing the malleability of resin, in the area of ​​the skull defect, artificial meninges, fat, autologous fascia, etc., are first used to repair the meninges. Then, using specialized equipment, resin is applied through the nasal cavity to cover the bone defect area, tightly integrating with the surrounding normal skull. It is then shaped according to the preoperative skull shape and irradiated with a specialized spectral irradiation instrument to cure the resin and form a unified whole with the surrounding normal skull. However, some drawbacks remain:

[0005] 1. In skull base repair after pituitary tumor surgery, simple soft reconstruction, lacking the support of rigid structures, is prone to failure under conditions of increased intracranial pressure post-surgery. Currently available rigid materials for repair, such as titanium alloys and PEEK, have disadvantages in skull base reconstruction, including poor plasticity and poor biocompatibility.

[0006] 2. While the aforementioned resin materials exhibit strong plasticity and wide applications in other fields, their biocompatibility in the human body has not been elucidated, leading to unknown biological rejection and potential reconstruction failures and rejection reactions in the human body. Furthermore, the complexity of the implementation process and the diverse range of external devices required limit their widespread application.

[0007] Therefore, this application proposes a skull base defect repair device with adjustable function. Utility Model Content

[0008] The purpose of this invention is to provide a skull base defect repair device with adjustable function, which solves the problems mentioned in the background art by providing the advantages of strong plasticity, good biological non-toxicity, compatibility and solubility.

[0009] To achieve the above objectives, the present invention provides the following technical solution: a skull base defect repair device with adjustable function, comprising a card body, wherein the front side of the card body is convex and the rear side of the card body is concave, and a clamping part is provided at the center of the front side of the convex side, the clamping part being arranged in an "I" shape.

[0010] Preferably, the convex surface is made of a rough material, and the concave surface is made of a smooth material.

[0011] Preferably, the card body is elliptical in shape, the thickness of the card body is 0.5-0.8 mm, the major axis length of the card body is 15.0-25.0 mm, the minor axis length of the card body is 15.0-20.0 mm, and the card body also has a certain curvature.

[0012] Preferably, the curvature of the card body is set between 5° and 25°.

[0013] Preferably, both the card body and the clamping part are made of β-tricalcium phosphate material that can absorb human bone, using machining or 3D printing technology.

[0014] Compared with the prior art, the beneficial effects of this utility model are:

[0015] By incorporating a card body and a clamping part, this invention uses β-tricalcium phosphate, a material that can absorb human bone, to create a rigid reconstruction compared to other materials. This material is manufactured using machining or 3D printing technology and exhibits excellent biodegradability, biocompatibility, and non-toxicity. It can serve as an ideal bone substitute for rigid reconstruction. Furthermore, this invention possesses the advantages of being ultra-thin, having stable clamping, and providing good sealing, which can significantly reduce the occurrence of complications such as rejection, postoperative cerebrospinal fluid leakage, postoperative brain tissue protrusion, and intracranial infection. Attached Figure Description

[0016] Figure 1 This is a front view structural diagram of the present invention;

[0017] Figure 2 This is a side view of the structure of this utility model;

[0018] Figure 3 This is a schematic diagram of the oblique structure of this utility model.

[0019] In the diagram: 1. Card body; 11. Convex surface; 12. Concave surface; 2. Clamping part. Detailed Implementation

[0020] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0021] Please see Figures 1 to 3 This utility model provides a technical solution: a skull base defect repair device with adjustable function, including a card body 1, the front side of the card body 1 is provided with a convex surface 11 and the rear side of the card body 1 is provided with a concave surface 12, and a clamping part 2 is provided at the center of the front side of the convex surface 11, the clamping part 2 is provided in the shape of "I".

[0022] Please see Figure 2 and Figure 3 The convex surface 11 is made of rough material, while the concave surface 12 is made of smooth material. The rough material of the convex surface 11 can increase friction, resulting in a stable clamping effect.

[0023] Please see Figure 2 Figure 3The card body 1 is elliptical in shape, with a thickness of 0.5–0.8 mm, a major axis length of 15.0–25.0 mm, and a minor axis length of 15.0–20.0 mm. The card body 1 also has a certain curvature. These features enable the present application to have the advantages of being ultra-thin and having a good sealing effect, which can greatly reduce the occurrence of complications such as rejection reaction, postoperative cerebrospinal fluid leakage, postoperative brain tissue protrusion, and intracranial infection.

[0024] Please see Figure 2 Figure 3 The curvature of the card body 1 is set between 5° and 25°. This setting, in conjunction with the above description, enables this application to have a good user experience.

[0025] Please see Figure 1 Both the card body 1 and the clamping part 2 are made of β-tricalcium phosphate material that can absorb human bone, using machining or 3D printing technology. As can be seen from the above description, this application is easy to produce and is made of β-tricalcium phosphate material that can absorb human bone.

[0026] Working principle: In pituitary tumor surgery, the sphenoid sinus is opened under transnasal-sphenoidal neuroendoscopy, the sella turcica bone is removed, the tumor is excised, and hemostasis is achieved. Gelatin sponge, artificial meninges, etc. are used for packing. During the operation, the card body 1 is appropriately trimmed according to the size of the bone window. The convex surface 11 is made of rough material and faces the nasal cavity; the concave surface 12 of the card body 1 is made of smooth material and faces the sella turcica. The tip of the clamping instrument is used to clamp the card body 1 from both sides of the horizontal axis of the clamping part 2. After the two sides are firmly attached, the card body 1 is sent to the surgical area. According to the size and shape of the bone window, the long axis of the card body 1 is selected and one end is inserted under the bone window. The card body 1 is held firmly and continues to be inserted laterally until the opposite end of its long axis meets the edge of the bone window. The opposite side is pushed under the bone window with a little force. The clamping part 2 is held firmly and the card body 1 is adjusted and rotated in various directions to achieve the most ideal closure effect.

[0027] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A skull base defect repair device with adjustable function, comprising a card body (1), characterized in that: The front side of the card body (1) is convex (11), and the rear side of the card body (1) is concave (12). A clamping part (2) is provided at the center of the front side of the convex surface (11), and the clamping part (2) is in the shape of an "I".

2. The skull base defect repair device with adjustable function according to claim 1, characterized in that: The convex surface (11) is made of a rough material, and the concave surface (12) is made of a smooth material.

3. The skull base defect repair device with adjustable function according to claim 1, characterized in that: The card body (1) is elliptical in shape, with a thickness of 0.5 to 0.8 mm, a major axis length of 15.0 to 25.0 mm, a minor axis length of 15.0 to 20.0 mm, and a certain curvature.

4. The skull base defect repair device with adjustable function according to claim 3, characterized in that: The curvature of the card body (1) is set between 5° and 25°.

5. The skull base defect repair device with adjustable function according to claim 1, characterized in that: Both the card body (1) and the clamping part (2) are made of β-tricalcium phosphate material that can absorb human bone, using machining or 3D printing technology.

Images