A fixation stent for intracranial interventional surgery

Abstract

This invention discloses a fixation stent for craniocerebral interventional surgery, belonging to the field of medical devices. It includes three interconnected supports: a first support, a second support, and a third support, and a fixing plate placed between the three supports. The second support has a first connecting hole on its back, and the first and third supports have connecting parts on their backs. A connecting rod passes through the connecting parts and the first connecting hole to connect the first, second, and third supports. Connectors are located at the bottom of the first, second, and third supports, and the fixing plate has a second connecting hole at a position corresponding to the connector. The first, second, and third supports and the fixing plate are connected through the connectors and the second connecting holes. The size of the support can be adjusted according to the patient's head circumference. A soft pad on the inner side prevents pressure injuries. The patient's face is exposed and can be directly observed, allowing for real-time monitoring of the patient's pupils, facial color, respiration, and the tightness and position of the endotracheal tube during the procedure.

Description

Technical Field

[0001] This invention relates to a fixation stent for craniocerebral surgery, and more particularly to a fixation stent for craniocerebral interventional surgery. Background Technology

[0002] Neurosurgery is characterized by its rapid onset and high mortality and disability rates, making it imperative to establish a green channel for emergency catheterization and interventional procedures. Close cooperation between the operating nurse and the surgeon is crucial; prior to cerebral angiography, it is essential to properly immobilize and protect the injured brain. However, existing neurosurgical fixation devices suffer from instability. Summary of the Invention

[0003] To address the aforementioned technical problems, this invention provides a fixation stent for craniocerebral interventional surgery, comprising a first stent, a second stent, and a third stent connected to each other, and a fixing plate placed between the three stents. The second stent has a first connecting hole on its back, and the first and third stents have connecting parts on their backs. A connecting rod passes through the connecting parts and the first connecting hole to connect the first, second, and third stents. The bottom of the first, second, and third stents has a connector, and the fixing plate has a second connecting hole at a position corresponding to the connector. The first, second, and third stents and the fixing plate are connected through the connector and the second connecting hole.

[0004] Furthermore, the surface of the fixation plate is made of a soft, pressure-resistant pad, which can make the patient comfortable and prevent pressure injuries.

[0005] Furthermore, the first support, the second support, the third support, and the fixed plate are connected by threads.

[0006] Furthermore, the outer sides of the first, second, and third supports and the fixing plate are made of X-ray transparent functional composite material and are hard; the inner sides of the first, second, and third supports and the fixing plate are made of X-ray transparent functional composite material and are soft.

[0007] Furthermore, X-ray transparent functional composite materials include phenolic resins, epoxy resins, and polyimides.

[0008] In summary, the present invention has the following advantages over the prior art:

[0009] The brace is a cube approximately 28cm in size, adjustable to fit the patient's head circumference. A soft pad on the inside ensures patient comfort and prevents pressure injuries. The patient's face is exposed and directly visible, allowing for continuous monitoring of pupils, facial color, respiration, and the tightness and position of the endotracheal tube during the procedure. Attached Figure Description

[0010] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this invention, illustrate exemplary embodiments of the invention and are used to explain the invention, but do not constitute an undue limitation of the invention. In the drawings:

[0011] Figure 1 A schematic diagram of the overall structure of a fixation stent for intracranial interventional surgery;

[0012] Figure 2 A side view of a fixation stent for interventional neurosurgery;

[0013] Figure 3 Exploded view of a fixation stent for interventional brain surgery.

[0014] The above figures include the following reference numerals:

[0015] 1. First support; 2. Second support; 21. First connecting hole; 3. Third support; 4. Fixing plate; 41. Second connecting hole; 5. Connecting part; 6. Connecting rod; 7. Connecting piece. Detailed Implementation

[0016] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0017] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments of the present invention. As used herein, the singular form may also include the plural form unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0018] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments do not limit the scope of the invention. It should also be understood that, for ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following figures denote similar items; therefore, once an item is defined in one figure, it need not be further discussed in subsequent figures.

[0019] See Figures 1 to 3 As shown, the present invention provides a fixation stent for craniocerebral interventional surgery, including a first support 1, a second support 2, and a third support 3 connected to each other, and a fixing plate 4 placed in the middle of the three supports. The second support 2 has a first connecting hole 21 on its back side, and the first support 1 and the third support 3 have connecting parts 5 on their back sides. A connecting rod 6 passes through the connecting part 5 and the first connecting hole 21, thereby realizing the connection of the first support 1, the second support 2, and the third support 3. The bottom of the first support 1, the second support 2, and the third support 3 has a connector 7. The fixing plate 4 has a second connecting hole 41 at the position corresponding to the connector 7. The first support 1, the second support 2, the third support 3, and the fixing plate 4 placed in the middle of the three supports are detachably connected through the connector 7 and the second connecting hole 41. After the three braces are connected to the fixation plate 4, they form a semi-open cube. The size can be adjusted to a suitable width according to the patient's head circumference, so that the patient's face is exposed and can be directly viewed. The purpose is to observe the patient's pupils, complexion, breathing, and whether the endotracheal tube is tightly connected and in place at any time during the operation.

[0020] As a preferred option, the surface of the fixation plate 4 is a soft, pressure-resistant pad, which can make the patient comfortable and prevent pressure injuries.

[0021] As a preferred embodiment, the first support 1, the second support 2, the third support 3 are connected to the fixing plate 4 by threads.

[0022] As a preferred embodiment, the outer surfaces of the first support 1, the second support 2, the third support 3, and the fixing plate 4 are made of X-ray transparent functional composite material and are hard; the inner surfaces of the first support 1, the second support 2, the third support 3, and the fixing plate 4 are made of X-ray transparent functional composite material and are soft.

[0023] Example 1: Component Details

[0024] The intracranial interventional surgical fixation stent provided in this embodiment includes a first support 1, a second support 2, a third support 3, and a fixation plate 4 as its core components. The connection method and material selection of each component strictly follow the principles of safety, practicality, and compatibility. The specific parameters and configurations are as follows:

[0025] (1) Component size reference: After the three braces and the fixing plate are assembled, the whole is a semi-open cube structure with a reference side length of 28cm (which can be adjusted by ±3cm according to actual clinical needs). It is suitable for the head circumference of most adult and adolescent patients (adult head circumference is usually 54-58cm, and adolescent head circumference is usually 50-54cm). By adjusting the structure, it can cover the usage needs of more than 95% of patients.

[0026] (2) Material layering design

[0027] The outer hard layer: The outer sides of the first support 1, the second support 2, the third support 3 and the fixation plate 4 are all made of X-ray transparent functional composite material. Specifically, it is a composite injection molded part of epoxy resin (model E-51) and glass fiber (content 30%). This material has good mechanical strength (flexural strength ≥120MPa), radiation resistance (can withstand the cumulative X-ray radiation dose ≥1000Gy in conventional interventional surgery), and X-ray transmittance of more than 98%, which does not affect intraoperative imaging observation.

[0028] Inner soft layer: The inner layer adopts a flexible modified version of the same type of X-ray transparent composite material. 15% nitrile rubber particles are added to the epoxy resin matrix and molded by compression molding process. The Shore hardness is controlled at 35-40D, which not only ensures X-ray transparent performance (transmittance ≥95%), but also has good fit and cushioning, avoiding pressure on the patient's head skin.

[0029] (3) Specifications of core connecting components

[0030] Connecting rod 6: Made of 304 stainless steel, 5mm in diameter and 30-40mm in length (different lengths can be selected according to the adjustment requirements of the brace), with a passivated surface (roughness Ra≤0.8μm) to avoid scratching medical staff or patients; with M5 anti-slip nuts, it can withstand ≥50N of lateral tension after tightening, ensuring a stable connection of the brace and no risk of loosening.

[0031] Connector 7: Made of medical-grade polyetheretherketone (PEEK), cylindrical in shape (8mm in diameter and 12mm in height), with M8 standard threads machined on the outer surface; the second connecting hole 41 on the fixing plate 4 is a matching M8 internal thread hole with a thread accuracy of 6H, ensuring that when the support and the fixing plate are connected by threads, the fit error is ≤0.5mm and there is no shaking.

[0032] Pressure ulcer pad: The pressure ulcer pad is attached to the surface of the fixation plate 4 and is made of medical polyurethane foam (density 30kg / m³). 3 The sponge is 5mm thick and covered with a hydrophilic antibacterial coating (antibacterial rate ≥99%, effective against common pathogens such as Escherichia coli and Staphylococcus aureus); the sponge has good resilience (compression rebound rate ≥90%), which can disperse the pressure on the patient's head (pressure distribution uniformity ≤10%), avoiding the risk of pressure sores caused by excessive local pressure (maximum local pressure ≤30mmHg).

[0033] Example 2: Usage Process

[0034] (1) Preoperative adjustment: Determine the brace width based on the patient's head circumference (measured with a soft ruler from the upper edge of the eyebrow to the occipital protuberance). If the patient's head circumference is large (e.g., >58cm), loosen the anti-slip nuts at both ends of the connecting rod 6, pull the first brace 1 and the third brace 3 outward to increase the lateral span of the frame, and adjust until the distance between the two braces and the scalp is 1-2cm (distance error ≤0.5cm) after the patient's head is placed in the frame. Then tighten the anti-slip nuts again (torque restored to 15-20N). If the patient's head circumference is small (e.g., <50cm), push the first brace 1 and the third brace 3 inward to reduce the span, ensure that the head does not shake significantly after being fixed, and avoid the braces compressing the head (compression pressure ≤10mmHg).

[0035] (2) Intraoperative use and monitoring: Place the adjusted fixation bracket in the corresponding position on the interventional operating table (compatible with the operating table guide rail, and fixed by buckles; displacement ≤0.5cm after fixation). Assist the patient to lie flat on the pressure-relief pad of fixation plate 4, ensuring complete facial exposure (the exposure area covers the entire face, including the eyes, mouth, nose, and endotracheal tube interface area). During the procedure, medical staff can monitor the exposed face in real time:

[0036] (3) Pupil status: Observe the size (normal diameter 2-4mm), shape (whether it is symmetrical) and light reflex (whether the direct and indirect light reflexes are sensitive) of both pupils, and record once every 5-10 minutes;

[0037] (4) Complexion and breathing: Observe whether the complexion is rosy (without cyanosis, paleness or other abnormalities), whether the breathing rate is normal (12-20 breaths / minute for adults, 18-24 breaths / minute for children), and whether the chest rise and fall is symmetrical;

[0038] (5) Endotracheal intubation status: Check whether the endotracheal tube is tightly connected to the ventilator (no air leakage, stable airway pressure, fluctuation range ≤5cmH2O), and whether the intubation depth is in place (the intubation depth of the adult oral tube is usually 22-24cm, and the intubation depth of the nasal tube is usually 26-28cm), to avoid untimely monitoring due to obstruction by the fixation bracket.

[0039] (6) Postoperative disassembly and cleaning: After the operation, first loosen the connector 7 between the fixation plate 4 and the brace, and remove the fixation plate 4; then loosen the anti-slip nut of the connecting rod 6 to separate the three braces. All components are cleaned and disinfected separately.

[0040] Metal parts (connecting rods, anti-slip nuts): First rinse the surface bloodstains and stains with running purified water, then soak in 2% glutaraldehyde disinfectant (soaking time ≥30 minutes), take them out and rinse 3 times with sterile saline, and finally wipe them dry with sterile gauze and store them in a sterile instrument box;

[0041] Plastic and composite material components (braces, fixing plates): sterilized by low-temperature hydrogen peroxide plasma (sterilization temperature 45-55℃, sterilization time ≥45 minutes) to ensure that the sterilization effect complies with WS 310.2-2016 "Hospital Disinfection Supply Center Part 2: Cleaning, Disinfection and Sterilization Technical Operation Specifications";

[0042] Pressure ulcer prevention pads: If they are single-use versions, dispose of them as medical waste; if they are reusable versions, soak them in a 50℃ medical cleaning agent for 10 minutes, gently rub to remove stains, rinse them with purified water, dry them in a medical dryer (temperature 60-70℃, drying time 30 minutes), and finally sterilize them with ethylene oxide (sterilization concentration 600-800mg / L, sterilization temperature 37-55℃, sterilization time ≥2 hours) for later use.

[0043] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A cranial intervention surgery fixing support, characterized in that, The utility model discloses a first support (1), second support (2), third support (3) and fixed plate (4) are connected to each other, the back of second support (2) is equipped with first connecting hole (21), and the back of first support (1) and third support (3) is equipped with connecting part (5), and connecting rod (6) passes through connecting part (5) and first connecting hole (21), to realize the connection of first support (1), second support (2) and third support (3);The bottom of first support (1), second support (2) and third support (3) is equipped with connecting piece (7), and the corresponding position of fixed plate (4) and connecting piece (7) is equipped with second connecting hole (41), and first support (1), second support (2), third support (3) and fixed plate (4) are connected through connecting piece (7) and second connecting hole (41).

2. The cranial intervention surgery fixation support according to claim 1, characterized in that, The surface of the fixed plate (4) is a soft pressure sore prevention pad, which can make the patient comfortable and prevent pressure injury.

3. The cranial intervention surgery fixation support according to claim 1, characterized in that, The first support (1), the second support (2), the third support (3) and the fixed plate (4) are connected through threads.

4. The cranial intervention surgery fixation support according to claim 1, characterized in that, The outer side of the first support (1), the second support (2), the third support (3) and the fixed plate (4) is made of X-ray transparent functional composite material, which is hard; the inner side of the first support (1), the second support (2), the third support (3) and the fixed plate (4) is made of X-ray transparent functional composite material, which is soft.

5. The cranial intervention surgery fixation support according to claim 4, characterized in that, The X-ray transparent functional composite material comprises phenolic resin, epoxy resin and polyimide.

Images