Sterile gown type bronchoscope protection device

Abstract

The utility model relates to a sterile bronchoscope cover type protecting device which comprises a sterile thin film, a negative pressure suction catheter is integrally connected to the sterile thin film, and a negative pressure connector connected with a negative pressure source is arranged at the near end of the negative pressure suction catheter. The sterile film is in a shape-imitating mode with the endoscope body and can be attached to the outside of the endoscope body in a matched full-wrapping mode, an easy-to-pull strip integrally formed with the sterile film is arranged on the outer wall of the sterile film from the far end to the near end of the endoscope body, the operation portion of the easy-to-pull strip is located at the near end of the endoscope body, and the sterile film can be gradually torn off from the far end by pulling the easy-to-pull strip. Therefore, the lens is finally stripped from the lens body. The sterile gown type bronchoscope protection device is a disposable article. By covering the surface of the bronchoscope body and integrating the suction catheter, the bronchoscope can effectively prevent secreta in the upper respiratory tract from being polluted before entering the lower respiratory tract and keep the interior and exterior of the bronchoscope body sterile, meanwhile, pollution is avoided during sputum culture and pulmonary alveolar lavage of a specimen, and the bronchoscope has a disposable and convenient falling mechanism.

Description

Technical Field

[0001] The utility model relates to a bronchoscope supporting auxiliary device, in particular to a sterile gown-type bronchoscope protective device, belonging to the technical field of medical equipment. Background Art

[0002] In the fields of critical care medicine and respiratory therapy, bronchoscopy and treatment through natural cavities (including the oral and nasal cavities) are common diagnostic and therapeutic interventions. A bronchoscope is inserted through the patient's upper respiratory tract into the trachea, bronchi, and distal bronchioles for examination or treatment. However, this process often involves contact between the scope and oral and nasal secretions, leading to microbial contamination of the device surface and even deep within. This not only interferes with the accuracy of diagnostic and treatment procedures but also poses a potential risk of infection.

[0003] Current bronchoscopes face the inevitable risk of microbial contamination during clinical use, which not only compromises the sterility of the equipment but also increases the risk of nosocomial infection. Despite rigorous cleaning, disinfection, and sterilization procedures, the problem of residual microorganisms in reusable bronchoscopes persists, making it difficult to completely eliminate the threat of cross-infection.

[0004] Traditional bronchoscopy requires the application of paraffin oil or other lubricants before operation, which not only increases the complexity of the procedure, but excessive lubricants can also cause patient discomfort, irritate the respiratory mucosa, increase the risk of aspiration, and other potential complications. These issues significantly increase the complexity and time of the procedure, and innovative solutions are urgently needed to improve the safety, accuracy, and overall comfort of bronchoscopy. Utility Model Content

[0005] This utility model patent aims to provide a bronchoscope protection device for operations through natural cavities. By covering the surface of the bronchoscope body and integrating a suction catheter, it can effectively prevent contamination of upper respiratory tract secretions before entering the lower respiratory tract, keep the inside and outside of the bronchoscope body sterile, and avoid contamination when collecting sputum culture and bronchoalveolar lavage (BAL) specimens. It has a disposable use and convenient shedding mechanism.

[0006] The utility model specifically adopts the following technical solutions:

[0007] A sterile goggles-cover-type bronchoscope protective device comprises a sterile film 1, to which a negative pressure suction catheter 3 is integrally connected, and the proximal end of the negative pressure suction catheter 3 has a negative pressure connector 301 connected to a negative pressure source; the sterile film 1 is contoured to the mirror body and can be fully wrapped around the outside of the mirror body in a matching manner; the outer wall of the sterile film 1 is provided with a pull-tab integrally formed with the sterile film from the distal end to the proximal end of the mirror body, the operating part of the pull-tab is at the proximal end of the mirror body, and pulling the pull-tab can gradually tear the sterile film 1 from the distal end, thereby eventually peeling it off from the mirror body; the sterile goggles-cover-type bronchoscope protective device is a disposable item.

[0008] Preferably, the outer side of the sterile film 1 has a water-lubricated coating.

[0009] Preferably, the inner side of the sterile film 1 also has a water-lubricated coating.

[0010] Preferably, the sterile film 1 is provided with a manually removable fixing ring 6 at the proximal end of the mirror body to assist in fixing the proximal end of the sterile film 1. The sterile film is stabilized on the mirror body by the fixing ring 6 to prevent displacement during the operation of tearing off the sterile film 6.

[0011] Preferably, the negative pressure connector 301 is provided with a valve with an adjustable opening for connecting to a negative pressure source.

[0012] Preferably, a plurality of suction side holes 5 are provided on the side wall of the negative pressure suction catheter 3 near the distal end.

[0013] A method for using the above-mentioned sterile mirror cover type bronchoscope protection device comprises the following steps in sequence:

[0014] S1. Initial setup: Unpack the outer packaging of the sterile gown-style bronchoscope protective device, insert the scope body into the sterile film protective device from the distal end, and ensure that the sterile film 1 fits the scope body; fix the fixing ring 6 on the proximal end of the bronchoscope to ensure that the sterile film 1 is in a stable position; confirm that the negative pressure suction catheter 3 is connected to the external negative pressure source, and check and ensure that the suction function is normal;

[0015] S2. Inserting the bronchoscope: The surface coating of the sterile film 1 produces a lubricating effect when exposed to water, reducing friction and patient discomfort during bronchoscope insertion; the bronchoscope enters the upper respiratory tract through the nasopharynx or oropharynx;

[0016] S3. Negative pressure suction when necessary: ​​Before the bronchoscope passes through the glottis and enters the lower respiratory tract, the negative pressure suction catheter aspirates secretions from the oral and nasal cavities, epiglottis, and surrounding accessory tissues to reduce contamination. This procedure avoids activating the bronchoscope's built-in suction channel, thereby preventing contamination inside and outside the bronchoscope.

[0017] S4. Pull the proximal end 4b of the pull-tab to tear the sterile film covering the bronchoscope body from the distal end, gradually removing it to ensure that the bronchoscope entering the lower respiratory tract remains sterile. At the same time, the film is stabilized on the bronchoscope body by the fixing ring 6 to prevent displacement during the operation until the sterile film 1 and the negative pressure suction catheter 3 are removed together.

[0018] S5. Further insert bronchoscope.

[0019] The beneficial effects of the present invention are:

[0020] 1) Solve the contamination problem encountered by existing bronchoscopes when entering the lower respiratory tract (including the trachea and bronchi) through the natural cavity (through the mouth and nasal cavity) for diagnosis and treatment. It can effectively prevent the bronchoscope from being contaminated by secretions when passing through the natural cavity, maintain the sterility of the inside and outside of the bronchoscope, and avoid contamination during sputum culture and next-generation sequencing (NGS) testing;

[0021] 2) The sterile film and negative pressure suction catheter are disposable and easy to remove to improve the safety and accuracy of the operation and increase the comfort of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is a schematic diagram of the utility model of a sterile goggles-style bronchoscope protective device installed on a bronchoscope. This figure also shows the bronchoscope body and the control handle.

[0023] Figure 2 This is a schematic diagram of the utility model of a sterile gown-type bronchoscope protective device. In the figure, 1. sterile film, 3. negative pressure suction catheter, 5. suction side hole, 6. fixing ring, 4a. distal end of the pull-tab, 4b. proximal end of the pull-tab. DETAILED DESCRIPTION

[0024] The present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0025] To further clarify the objectives, advantages, and features of the present invention, the present invention is further described below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are highly simplified and not drawn to scale, and are intended solely to facilitate and clearly illustrate the objectives of the embodiments of the present invention. Furthermore, the structures shown in the drawings are often portions of the actual structures. In particular, different drawings may require different emphases and may use different scales.

[0026] As used herein, the terms "proximal," "distal," and "tip end" are used to describe the relative orientation and position of various components and elements of a medical device. Although non-limiting, "proximal" generally refers to the end of the medical device closest to the operator during normal use, while "distal" and "tip end" generally refer to the end of the medical device away from the operator. The term "axial" refers to the direction along the longitudinal axis of the bronchoscope catheter.

[0027] See also Figure 1 , Figure 1 The appearance of the bronchoscope is shown. From the perspective of the appearance and structure of the bronchoscope, after removing the negative pressure suction catheter 3, the appearance of the bronchoscope is the same as that of the bronchoscope in the prior art.

[0028] See also Figure 2 , Figure 2 The utility model shows a sterile mirror cover type bronchoscope protection device. The utility model is a disposable consumable.

[0029] The utility model aims to solve the contamination problem encountered by existing bronchoscopes during the diagnosis and treatment process of entering the lower respiratory tract (including the trachea and bronchi) through the natural cavity (through the oral and nasal cavities).

[0030] The relationship between components and the connection method, combined with Figure 1 and Figure 2 :

[0031] Sterile film 1:

[0032] -The coating is evenly applied on the surface of the sterile film to form a smooth protective film;

[0033] -The coating can produce a lubricating effect when it comes into contact with water, reducing friction and avoiding patient discomfort.

[0034] Negative pressure suction catheter 3:

[0035] - The negative pressure suction catheter 3 is integrally formed or adhered to the outer wall of the sterile film 1;

[0036] One end of the negative pressure suction catheter 3 can be connected to an external suction device, and the other end is provided with multiple side holes 5.

[0037] Easy pull strips:

[0038] - The pull-tab is fixed on the sterile film 1, extending from the distal end 4a of the pull-tab to the proximal end 4b. The pull-tab is integrally formed with the film or fixed by an adhesive.

[0039] -By pulling the easy-pull tab at the end, tear off the film covering the bronchoscope body from the distal end, allowing it to gradually fall off, ensuring that the bronchoscope entering the lower respiratory tract is in a sterile state.

[0040] Fixed ring 6:

[0041] -Fixation: 6 is set at the proximal end of the sterile film, and the film is stabilized on the bronchoscope body through the fixing structure to prevent displacement during operation.

[0042] Specifically, the following technical means are used:

[0043] See also Figure 1-2 A sterile mirror cover-type bronchoscope protective device includes a sterile film 1, to which a negative pressure suction catheter 3 is integrally connected, and the proximal end of the negative pressure suction catheter 3 has a negative pressure connector 301 connected to a negative pressure source; the sterile film 1 is attached to the outside of the mirror body, and an easy-pull strip integrally formed with the sterile film is provided on the outer wall of the sterile film 1 from the distal end to the proximal end of the mirror body, and the operating part of the easy-pull strip is at the proximal end of the mirror body. Pulling the easy-pull strip can gradually tear the sterile film 1 from the distal end, thereby finally peeling it off from the mirror body; the sterile film 1 and the negative pressure suction catheter 3 are disposable items.

[0044] In this embodiment, the outer side of the sterile film 1 has a water-lubricated coating.

[0045] In this embodiment, the inner side of the sterile film 1 also has a water-lubricated coating.

[0046] It should be noted that in the field of medical devices, water-lubricated coatings are primarily used to reduce friction during the operation of catheters and other medical devices inside the human body, improving the safety and efficiency of surgery while reducing the high risk of reflux and aspiration and the pain of patients. These coatings are already in the existing technology. After curing, the medical-grade hydrophilic coating solution bonds tightly to the substrate and exhibits excellent lubricity when activated by water. Hydrophilic coatings are dry when dry and lubricated when fully wetted. They may appear sticky if there is a small amount of sweat on the hands. Hydrophilic coatings are hydrogels with a surface strength similar to that of human mucosal tissue. The following are some specific applications and features:

[0047] Hydrophilic ultra-slip coating: Developed by Gemet Coating Technology, this coating significantly reduces frictional resistance on medical device surfaces, making it easier for catheters to navigate through blood vessels and preventing abrasion between the device surface and tissue / vessel walls. This improves patient comfort and reduces the risk of infection. This coating exhibits excellent biocompatibility and can be sterilized using ethylene oxide and electron beams. It has been registered with the FDA and has extensive drug regulatory approvals.

[0048] Bionic hydrophilic lubricating coating from Lanzhou Institute of Chemical Physics: Researchers from the Lanzhou Institute of Chemical Physics, Chinese Academy of Sciences, have proposed a new method to grow hydrogel lubricating coatings on the surfaces of general materials and medical devices through ultraviolet-induced surface catalytic free radical polymerization (UV-SCIRP). The coating has good bonding strength with the substrate and effectively changes the wetting and water lubrication properties of the substrate surface.

[0049] In addition to the above, there are other specific products of water-lubricated lubricating coatings, which belong to the existing technology and whose basic applications and principles can be directly known to those skilled in the art.

[0050] In this embodiment, see Figure 1 The outer periphery of the sterile film 1 is provided with a manually removable fixing ring 6 at the proximal end of the mirror body to assist in fixing the proximal end of the sterile film 1. The fixing ring 6 can prevent the sterile film from shifting during operation. In this embodiment, see Figure 1 , the negative pressure connector 301 is connected to the negative pressure source.

[0051] In this embodiment, see Figure 1-2 The negative pressure suction catheter 3 is provided with a plurality of suction side holes 5 on the side wall near the distal end.

[0052] The specific operation includes the following steps in sequence:

[0053] S1. Initial setup: Unpack the outer packaging of the sterile gown-style bronchoscope protective device, insert the scope body into the sterile film protective device from the distal end, and ensure that the sterile film 1 fits the scope body; fix the fixing ring 6 on the proximal end of the bronchoscope to ensure that the sterile film 1 is in a stable position; confirm that the negative pressure suction catheter 3 is connected to the external negative pressure source, and check and ensure that the suction function is normal;

[0054] S2. Inserting the bronchoscope: The surface coating of the sterile film 1 produces a lubricating effect when exposed to water, reducing friction and patient discomfort during bronchoscope insertion; the bronchoscope enters the upper respiratory tract through the nasopharynx or oropharynx;

[0055] S3. Negative pressure suction when necessary: ​​Before the bronchoscope passes through the glottis and enters the lower respiratory tract, the negative pressure suction catheter aspirates secretions from the oral and nasal cavities, epiglottis, and surrounding accessory tissues to reduce contamination. This procedure avoids activating the bronchoscope's built-in suction channel, thereby preventing contamination inside and outside the bronchoscope.

[0056] S4. Pull the proximal end 4b of the pull-tab to tear the sterile film covering the bronchoscope body from the distal end, gradually removing it to ensure that the bronchoscope entering the lower respiratory tract remains sterile. At the same time, the film is stabilized on the bronchoscope body by the fixing ring 6 to prevent displacement during the operation until the sterile film 1 and the negative pressure suction catheter 3 are removed together.

[0057] S5, further inserting bronchoscope. The purpose and function that this utility model can achieve:

[0058] Prevent bronchoscope contamination: The bronchoscope is fully covered with a sterile protective film to prevent the inside and outside of the scope from being contaminated by secretions and microorganisms when passing through the oral and nasal cavities, ensuring that it remains sterile when entering the lower respiratory tract, effectively reducing the risk of infection; reducing the risk of infection caused by equipment contamination and reducing the occurrence of nosocomial infections.

[0059] Improve diagnostic accuracy: When conducting tests such as sputum culture and high-throughput sequencing (NGS), it can prevent oral and nasal secretions from contaminating test samples, ensure the accuracy of test results, and improve clinical diagnosis and treatment effects.

[0060] Reduces the risk of reflux aspiration and patient discomfort: The film material exhibits excellent flexibility, adsorption, sealing, and biocompatibility. Its film-like structure ensures a tight, fully wrapped wrap around the outside of the bronchoscope, effectively preventing contamination and ensuring effective protection. Furthermore, the sterile protective film is coated with a special water-lubricating coating, reducing the use of traditional lubricants such as paraffin oil, preventing the discomfort and potential complications caused by excessive lubricant entering the patient's lower respiratory tract, and improving safety.

[0061] A negative pressure suction catheter 3 is integrated on the outside of the film and can be connected to a suction device to effectively attract secretions in the oral and nasal cavities before entering the lungs, and is removed along with the sterile film before entering the lower respiratory tract. This avoids opening the negative pressure suction channel of the bronchoscope, thereby further reducing the risk of contamination.

[0062] Simplified operation process: A convenient shedding mechanism is designed. As the bronchoscope gradually passes from the front end through the glottis and into the lower respiratory tract, the film can be torn away from the head end using a pull tab at the end of the film. This operation requires a special technique to ensure that the film is gradually and evenly detached without compromising the sterility of the bronchoscope. This allows the protective film to be quickly detached before the bronchoscope reaches the lungs, simplifying the operation steps and reducing operation time and complexity.

[0063] A disposable protective device is provided to avoid the problem of microbial residue during the cleaning and disinfection of reused bronchoscopes.

[0064] Principle description:

[0065] During bronchoscopic examination and treatment, the bronchoscope needs to pass through the nasopharynx or oropharynx before it can pass through the glottis and penetrate into the lower respiratory tract. Due to the presence of a large number of bacteria and secretions in the oral and nasal cavities, traditional bronchoscopes are easily contaminated during insertion, increasing the risk of infection and affecting the accuracy of diagnosis and treatment. At the same time, the use of excessive lubricating oil (such as paraffin oil) may cause it to enter the patient's lower respiratory tract and cause complications. In order to address these problems, a disposable sterile mirror cover-type bronchoscope protective device has been developed to keep the inside and outside of the bronchoscope sterile, reduce the risk of infection in patients, and improve the safety and comfort of operation.

[0066] 1. Sterile barrier principle: By using a sterile film to completely wrap the bronchoscope, an effective sterile barrier is formed to prevent the bronchoscope from being contaminated by secretions and bacteria when passing through the oral and nasal cavity.

[0067] 2. Negative pressure suction principle: A negative pressure suction catheter (small suction pump) is integrated on the outer wall of the sterile film and connected to an external suction device. Before the bronchoscope enters the lungs, negative pressure suction can effectively attract and clear secretions in the oral and nasal cavity, further reducing the risk of contamination.

[0068] 3. Lubrication principle: A layer of lubricant that produces a lubricating effect when in contact with water is applied to the surface of the sterile film to reduce friction and patient discomfort during bronchoscope insertion, while preventing excessive lubricating oil (such as paraffin oil) from entering the lower respiratory tract.

[0069] 4. Mechanical Shedding Principle: A fixing ring 6 is provided at the proximal end of the sterile film 1 to secure the film to the bronchoscope. A pull tab is provided at the distal end of the film. The operator pulls the tab to tear the film from the distal end, gradually shedding it, ensuring the bronchoscope remains sterile as it enters the lower respiratory tract.

[0070] Operation process:

[0071] 1. Initial Setup: Prepare sterile gauze and sterile water for injection or 0.9% normal saline. Remove the sterile goggles and protective cover for the bronchoscope. Wrap the sterile film tightly around the outside of the bronchoscope, ensuring a seamless fit. Secure the retaining ring to the end of the bronchoscope lens to ensure a stable position. Connect the negative pressure suction catheter to the external suction device and check that the suction function is functioning properly.

[0072] 2. Insertion of bronchoscope: The surface coating of the sterile film produces a lubricating effect when it comes into contact with water, reducing friction and patient discomfort during bronchoscope insertion; the bronchoscope enters the upper respiratory tract through the natural cavity (nasopharynx or oropharynx).

[0073] 3. Negative pressure suction if necessary:

[0074] Before the bronchoscope passes through the glottis and enters the lower respiratory tract, the negative pressure suction catheter suctions secretions from the oral and nasal cavities, epiglottis and surrounding accessory tissues to reduce contamination.

[0075] 4. Activate the shedding mechanism: As the bronchoscope gradually passes through the glottis and enters the lower respiratory tract, the operator uses the pull tab at the proximal end of the film to tear the film from the wrapping at the distal end 4a of the pull tab; as the film peels off evenly, the bronchoscope body gradually enters the lower respiratory tract, ensuring that the bronchoscope remains sterile when entering the lower respiratory tract; remove the fixing ring. The specific steps are as follows:

[0076] ① Positioning the pull-tab: As the bronchoscope gradually approaches the glottis, the operator positions the end of the pull-tab at the end of the film.

[0077] ② Tear the film: Pull the end of the pull tab to tear the film from the distal wrapping. The operator should apply force slowly and evenly. A retaining ring 6 is provided at the proximal end of the disposable sterile film body 1. This retaining ring 6 stabilizes the sterile film 1 on the scope body to prevent shifting during operation.

[0078] ③ Gradual shedding and synchronous in-and-out: As the bronchoscope continues to enter the lower respiratory tract, the film gradually falls off the mirror body; during this process, the operator needs to maintain a stable pulling force to ensure that the film is evenly separated from the mirror body.

[0079] ④ Completely detached: When the bronchoscope completely passes through the glottis and enters the lower respiratory tract, the film has completely detached and been removed, ensuring that the bronchoscope remains sterile when entering the lower respiratory tract.

[0080] This shedding mechanism not only ensures the sterility of the operation process, but also avoids bronchoscope contamination, improving the safety and effectiveness of the operation.

[0081] Operation completed: The bronchoscope completes the examination or treatment under sterile conditions; after the operation is completed, the bronchoscope is removed and the detached film and other waste are disposed of.

[0082] In summary, the utility model provides a safe, efficient and easy-to-operate bronchoscope protection device, which significantly improves many problems encountered during the use of traditional bronchoscopes, improves the safety of medical operations and diagnostic accuracy, and enhances patient comfort.

[0083] The above are preferred embodiments of the present invention. Ordinary technicians in this field can also make their own changes or improvements on this basis. Without departing from the overall concept of the present invention, these changes or improvements should fall within the scope of protection required by the present invention.

Claims

1. A sterile gown-type bronchoscope protective device, characterized by: It comprises a sterile film (1), a negative pressure suction catheter (3) is integrally connected to the sterile film (1), and the proximal end of the negative pressure suction catheter (3) has a negative pressure connector (301) connected to a negative pressure source; The sterile film (1) is contoured to the mirror body and can be fully wrapped around the outside of the mirror body in a matching manner. The outer wall of the sterile film (1) is provided with a pull-tab integrally formed with the sterile film from the distal end to the proximal end of the mirror body. The operating portion of the pull-tab is at the proximal end of the mirror body. Pulling the pull-tab can gradually tear the sterile film (1) from the distal end, thereby finally peeling it off from the mirror body. The sterile goggles-style bronchoscope protective device is a disposable item.

2. The sterile gown-type bronchoscope protection device according to claim 1, characterized in that: The outer side of the sterile film (1) is provided with a water-lubricated coating.

3. The sterile gown-type bronchoscope protection device according to claim 1, characterized in that: The inner side of the sterile film (1) also has a water-lubricated coating.

4. The sterile gown-type bronchoscope protection device according to claim 1, characterized in that: The sterile film (1) is provided with a manually removable fixing ring (6) at the proximal end of the mirror body for assisting in fixing the proximal end of the sterile film (1). The fixing ring (6) stabilizes the sterile film on the mirror body to prevent displacement during the operation of tearing off the sterile film (1).

5. The sterile gown-type bronchoscope protection device according to claim 1, characterized in that: The negative pressure connector (301) is provided with a valve with an adjustable opening, and is used for connecting to a negative pressure source.

6. The sterile gown-type bronchoscope protection device according to claim 1, characterized in that: A plurality of suction side holes (5) are provided on the side wall of the negative pressure suction catheter (3) close to the distal end.

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