alveolar lavage device

Abstract

The alveolar lavage device disclosed in the present invention includes a suction catheter for entering the bronchus through the insertion tube of an endoscope for alveolar lavage, and an ultrasound probe for entering the bronchus through the suction catheter. The suction catheter includes an opaque flexible segment at the distal end and a transparent segment connected to the proximal end of the flexible segment. The transparent segment has a greater hardness than the flexible segment. Using this alveolar lavage device, the shape of the bronchus into which the suction catheter enters and the flow path of the suction catheter can be observed in real time, preventing clogging of the suction catheter.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and in particular to an alveolar lavage device. Background Art

[0002] Suction catheters are commonly used to insert into the lumen of a patient's body to sample secretions or other materials within the lumen and aspirate them to the outside of the body using negative pressure equipment. For example, by injecting a sufficient amount of lavage fluid into the bronchial or subsegmental lung level through an endoscope and its insertion tube, and then fully aspirating and recovering the lavage fluid, bronchial secretions can be sampled and tested. This can provide important information at the alveolar level, such as immune cells, inflammatory cells, cytology, and the etiology of infectious microorganisms, assisting in the diagnosis, observation, and prognosis of respiratory diseases, and is of great clinical significance.

[0003] In the traditional bronchoalveolar lavage surgery currently widely performed at home and abroad, the surgeon generally uses a hose to connect one end of the collector to the connector of the working channel of the endoscope, and the other end of the collector to the negative pressure device. The lavage fluid is injected directly into the target bronchus through the working channel hole of the endoscope, or the catheter is passed through the working channel of the endoscope to reach the target position and the lavage fluid is injected from the catheter. When the bronchoalveoli are filled with lavage fluid, the negative pressure switch on the endoscope is pressed, and the liquid in the target bronchus can be sucked into the collector through the working channel hole at the distal end of the endoscope, thus completing a lavage and suction.

[0004] This lavage surgery has the following defects: 1. The distal end of the endoscope or its matching insertion tube is limited by its size and cannot be extended into the more secondary, i.e., thinner, bronchi for lavage and suction. The lavage fluid after lavage will flow into the more secondary bronchi, so the recovered lavage fluid may be contaminated by the secretions in the more secondary bronchi, or the secretions in the more secondary bronchi cannot be sampled. These reasons result in the samples obtained not being able to truly reflect the pathogens in the target bronchus, and accurate pathological searches cannot be performed; 2. When the lesion segment is located in the more secondary bronchus, the insertion tube needs to be pushed to the distal end, which will gradually move away from the visual range of the endoscope. Currently, the insertion tube is usually pushed based on preoperative CT images combined with the doctor's experience, which leads to uncertainty in the pushing position; respiratory operating rooms do not always have DSA imaging equipment, and the position of each bronchi cannot be identified by angiography. Even if some operating rooms are equipped with DSA imaging equipment, the identification of each segment of the bronchus is done by injecting contrast agents into the patient, which inevitably causes some contrast agents to be retained in the bronchi, which may cause complications; 3. There is often mucus or other secretions in the diseased bronchi, and the suction catheter is likely to be blocked during the process of suctioning and recovering the lavage fluid. The existing endoscope cannot directly observe the flow path of the suction catheter in a timely manner. Over time, the lavage fluid may expand from the lesion to other non-lesioned bronchi, increasing the risk of contamination of other healthy segments, and may even cause the surgeon to mistakenly believe that the lavage fluid has been completely recovered, resulting in excessive lavage fluid retention in the body. Summary of the Invention

[0005] In view of the defects of the above-mentioned prior art, the object of the present invention is to provide an alveolar lavage device that can enter the secondary bronchus along the insertion tube of the existing endoscope to perform alveolar lavage and can observe the flow path of the suction catheter in real time.

[0006] A technical solution employed to achieve the objectives of the present invention is a bronchial alveolar lavage device comprising a suction catheter for entering the bronchus via an insertion tube of an endoscope for bronchial lavage, and an ultrasound probe for entering the bronchus via the suction catheter. The suction catheter comprises an opaque flexible segment at a distal end and a transparent segment connected to a proximal end of the flexible segment, wherein the transparent segment has a greater hardness than the flexible segment.

[0007] The alveolar lavage device's suction catheter can be inserted into a more secondary bronchus along the insertion tube of an existing endoscope, and the ultrasound probe can be inserted into the more secondary bronchus along the suction catheter. Therefore, using the alveolar lavage device, the ultrasound probe's ultrasound image can be used to observe the morphology of the bronchus being entered, allowing the doctor to selectively advance the distal end of the suction catheter into the desired affected bronchial segment based on the observation results. Furthermore, the transparent section allows for real-time observation of the suction catheter's flow path to prevent blockage.

[0008] In the alveolar lavage device provided in one embodiment of the present invention, the distal end of the flexible section includes a plurality of corrugated structures connected end to end in sequence along the axial direction, and the wave height of each corrugated structure is 0.2mm-0.4mm and the wavelength is 1mm-2mm.

[0009] In the alveolar lavage device provided in one embodiment of the present invention, at least one superelastic core wire having a wiring direction consistent with the multiple waveform structures is embedded in the tube wall of the flexible segment, and the distance between the distal end of the core wire and the distal end of the flexible segment is 1mm-3mm.

[0010] In the alveolar lavage device provided in one embodiment of the present invention, the inner wall of the transparent section has a hydrophilic coating, and the transparency of the transparent section is 60%-95%.

[0011] In the alveolar lavage device provided in one embodiment of the present invention, the suction catheter is a linear equal-diameter structure, and its tube wall is provided with multiple injection holes; or the distal end of the suction catheter has a pre-bent structure, and the large bend side of the pre-bent structure is provided with at least one injection hole; or the proximal end of the flexible section is a tapered structure, and the inner diameter of the tapered structure gradually decreases from the proximal end to the distal end; the area of the injection hole closest to the proximal end of the flexible section is ±15% of the cross-sectional area of the flow channel cavity of the suction catheter.

[0012] In the alveolar lavage device provided in one embodiment of the present invention, the distal end of the transparent segment is stacked with the proximal end of the flexible segment; or the distal end of the transparent segment and the proximal end of the flexible segment both include a plurality of petals radially spaced from each other, and the plurality of petals of the transparent segment and the plurality of petals of the flexible segment are cross-stacked one by one.

[0013] In the alveolar lavage device provided in one embodiment of the present invention, the inner wall of the transparent section is provided with multiple pairs of protrusions arranged at intervals along the axial direction, the two protrusions in each pair of protrusions are axially symmetrical, and the inner diameter of the flexible section is smaller than the inner diameter of the transparent section.

[0014] In the alveolar lavage device provided in one embodiment of the present invention, at least one superelastic reinforcing wire is axially provided in the tube wall of the transparent section, and the reinforcing wire is connected to the core wire.

[0015] In the alveolar lavage device provided in one embodiment of the present invention, the suction catheter further includes a connecting section, the ends of which are fixed to and communicate with the flexible section and the transparent section, respectively. The connecting section and the transparent section are made of the same material but different colors, and the connecting section and the flexible section are made of different materials but the same color. Thus, the connecting section and the transparent section can be firmly joined by hot-melting in a butt-jointed manner, eliminating the need for overlapping hot-melting. The connecting section and the flexible section can be joined by overlapping or petal-shaped hot-melting, thus avoiding the generation of multiple colors at the junction of the connecting section, the transparent section, and the flexible section due to hot-melting, which could interfere with the doctor's judgment.

[0016] In the alveolar lavage device provided in one embodiment of the present invention, the alveolar lavage device also includes a three-way valve having an injection chamber, a suction catheter connecting chamber and a suction tube connecting chamber. The suction catheter connecting chamber is adapted to be plugged into the proximal end of the transparent section, and the suction tube connecting chamber is adapted to be plugged into the suction tube. The inner diameters of the suction catheter connecting chamber and the suction tube connecting chamber are both larger than the diameter of the flow channel chamber of the suction catheter.

[0017] In an alveolar lavage device provided in one embodiment of the present invention, the suction device further includes a fluid collection bottle, comprising a bottle body with an open distal end and a closed proximal end, a distal end cap, and a proximal end cap. The distal end cap is removably threadedly connected to the distal end of the bottle body, and the proximal end cap is removably threadedly connected to the proximal end of the bottle body and adapted to be removably threadedly connected to the distal end of the bottle body. The suction tube is adapted so that its two ends communicate with the suction tube connection cavity and the bottle body, respectively. Using this suction device, after obtaining a lavage fluid sample and removing the suction tube and suction catheter, the distal end cap can be removed, and the proximal end cap can then be directly used to seal the bottle opening to prevent sample contamination.

[0018] In an alveolar lavage device provided in one embodiment of the present invention, the suction device further includes a drain valve disposed on the circumference of the bottle body and a drain tube connected to the drain valve. When a large amount of lavage fluid is recovered, the drain valve can be opened to drain the excess lavage fluid into a collection bucket or waste bucket, thereby avoiding frequent bottle changes and reducing surgical time. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying any creative work.

[0020] Figure 1 The structure of the alveolar lavage device provided by one embodiment of the present invention is schematically shown when the ultrasound probe is not included;

[0021] Figure 2 Schematically shows the use of Figure 1 Schematic diagram of alveolar lavage device used in conjunction with existing endoscope and insertion tube for alveolar lavage;

[0022] Figure 3 Shown Figure 1 Schematic diagram of the distal end of the aspiration catheter of the alveolar lavage device passing through the insertion tube of an existing endoscope and entering the bronchus;

[0023] Figure 3a Shown Figure 1 Schematic diagram of the alveolar lavage device with the ultrasound probe passed through the distal end of the suction catheter into the bronchus;

[0024] Figure 4 Shown Figure 3 The schematic diagram of the suction catheter after being cut open along the axial direction is shown;

[0025] Figure 4a Shown Figure 3 A schematic diagram of an improved embodiment of the suction catheter shown is shown after being cut apart along the axial direction;

[0026] Figure 5 A schematic diagram showing a transparent section and a flexible section of an aspiration catheter provided by an embodiment of the present invention forming a pre-bent structure is shown;

[0027] Figure 6 The figure schematically shows the structure of a suction catheter provided by another embodiment of the present invention after being cut open along the axial direction;

[0028] Figure 7 The structure of a suction catheter provided by another embodiment of the present invention is schematically shown after being cut apart along the axial direction;

[0029] Figure 8 The first structural diagram of the transparent section and the flexible section of the suction catheter provided by one embodiment of the present invention after heat fusion is schematically shown;

[0030] Figure 9 A schematic diagram of a second structure of the aspiration catheter provided by one embodiment of the present invention after the transparent section and the flexible section are heat-fused is shown;

[0031] Figure 10 A schematic diagram of a third structure of the aspiration catheter provided by one embodiment of the present invention after the transparent section and the flexible section are heat-fused is shown;

[0032] Figure 11 Schematically shows Figure 5 A schematic structural diagram of a suction catheter having a spray hole provided on the large curved side of the flexible section;

[0033] Figure 12 The structure diagram of the liquid collecting device of the alveolar lavage device provided by one embodiment of the present invention is schematically shown;

[0034] Figure 13 Schematically shows Figure 12 A schematic diagram of the liquid collecting device shown after the liquid collecting bottle and the distal end cap are detachably separated;

[0035] Figure 14 A schematic diagram schematically illustrates a case where the area of at least one injection hole of a suction catheter provided by an embodiment of the present invention is equivalent to the cross-sectional area of the flow channel cavity;

[0036] Figure 15 The structure diagram of the liquid collecting device of the alveolar lavage device provided by one embodiment of the present invention is schematically shown;

[0037] Figure 16 The schematic diagram shows the structure of the cooperation between the suction catheter and the radioactive seeds of the alveolar lavage device provided by one embodiment of the present invention;

[0038] Figure 17 The schematic diagram shows the structure of the cooperation between the suction catheter and the radioactive seeds of the alveolar lavage device provided by one embodiment of the present invention;

[0039] Figure 18 Schematically shows Figure 17 A schematic structural diagram of the protrusion of the suction catheter after being cut open along the axial direction;

[0040] Figure 19 The structure diagram of the suction catheter of the alveolar lavage device provided by one embodiment of the present invention is schematically shown;

[0041] Figure 20 The structure diagram of the suction catheter of the alveolar lavage device provided by one embodiment of the present invention is schematically shown;

[0042] Figure 21 The structure diagram of the suction catheter of the suction device provided by the eighth embodiment of the present invention is schematically shown. DETAILED DESCRIPTION

[0043] The following will clearly and completely describe the technical solutions of various embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only some of the embodiments of the present invention. Moreover, all other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without inventive effort are also within the scope of protection of the present invention.

[0044] It should be noted that all directional indications in the embodiments of the present invention are only used to explain the relative position relationship and movement status of various components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0045] In the present description, "plurality" means at least two, such as two or three, unless otherwise specifically defined. Unless otherwise specified or defined, the terms "connected" and "fixed" should be interpreted broadly. For example, "fixed" can mean a fixed connection, a detachable connection, or an integrated connection. Those skilled in the art will understand the specific meanings of these terms in the present description based on the specific circumstances.

[0046] In addition, the technical solutions between the various embodiments of the present invention can be combined with each other, but it must be based on the fact that ordinary technicians in this field can implement it. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0047] It should be noted that the terms "distal" and "proximal" are commonly used in the medical device field. "Distal" refers to the end away from the operator during surgery, while "proximal" refers to the end closer to the operator. Axial refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; radial refers to the direction perpendicular to the axial direction.

[0048] An alveolar lavage device 100 provided in one embodiment of the present invention includes: Figure 1 The suction catheter 110 shown, the three-way valve 120 adapted to be plugged into the proximal end of the suction catheter 110, the liquid collection device, and the like Figure 3a The ultrasound probe 400 is shown. The suction catheter 110 includes an opaque flexible section 112 at the distal end, a proximal connector 113, and a transparent section 114 fixed to and communicating with the flexible section 112 and the proximal connector 113 at both ends. The liquid collection device includes a suction tube 134 and a negative pressure tube 135, each connected to a three-way valve 120, and a liquid collection bottle 130 connected to the proximal ends of the suction tube 134 and the negative pressure tube 135.

[0049] The three-way valve 120 is fixed to the distal end of the suction tube 134. When using the suction device 100, the proximal connector 113 needs to be inserted into the suction catheter connecting cavity 122 of the three-way valve 120 so that the two are fixedly connected to each other. After use, the proximal connector 113 needs to be pulled out from the suction catheter connecting cavity 122 of the three-way valve 120. This insertion and pulling out is the detachable connection between the suction catheter 110 and the three-way valve 120.

[0050] In an improved embodiment of the present invention, the three-way valve 120 is fixed to the proximal connector 113 of the suction catheter 110 and formed integrally therewith, that is, the suction catheter 110 includes the three-way valve 120. In this case, when using the suction device 100, the distal end of the suction tube 134 needs to be inserted into the suction tube connection cavity 123 of the three-way valve 120 to securely connect the two. After use, the suction tube 134 needs to be removed from the suction tube connection cavity 122. This insertion and removal constitutes the detachable connection between the suction catheter 110 and the suction tube 134.

[0051] The ultrasound probe 400 can be used with existing ultrasound equipment, which can be commercially available. Its structure is not described in detail here. The diameter of the ultrasound probe 400 can be 1.7 mm, and the inner diameter of the suction catheter 110 is preferably 1.8 mm to 2.2 mm.

[0052] The alveolar lavage device 100 can be used with an existing endoscope and its insertion tube. For example, see Figure 2 , the insertion tube 210 of the existing endoscope 200 can be extended into the lesion segment of the patient's lung bronchus. Then, the distal end of the suction catheter 110 is extended from the distal end of the insertion tube 210 to the predetermined position of the patient's bronchus through the working channel 220 of the endoscope 200, such as Figure 3 As shown. The outer diameter of the suction catheter 110 is smaller than that of the insertion tube 210, so the suction catheter 110 can be inserted into a deeper branch bronchus than the insertion tube 210. When the distal end of the suction catheter 110 is away from the visual range of the endoscope 200, the ultrasound probe 400 can be inserted into the bronchus through the suction catheter 110, as shown. Figure 3a As shown. Thus, the bronchial morphology can be observed through the ultrasound image formed by the ultrasound probe 400. The doctor can selectively enter the desired bronchial segment with disease according to the observation results, thereby achieving the purpose of accurate irrigation, improving the cleaning treatment effect and pathogen detection rate. Then, the irrigation fluid is injected through the injection port 121 of the three-way valve 120, and the irrigation fluid passes through the suction catheter 110 as shown. Figure 4 The spray hole 1141 sprays fluid into the affected bronchus, thereby cleaning the affected bronchus. Finally, the negative pressure source 300 is activated, and the lavaged fluid is drawn through the suction catheter 110, three-way valve 120, and suction tube 134 into the fluid collection bottle 130 for recovery, thus completing the lavage of the bronchoalveoli in the affected segment.

[0053] See also Figure 4 The transparent section 114 of the suction catheter 110 has a flow channel lumen 115 running through the distal end and the proximal end thereof. The diameter of the flow channel lumen 115 is 1.2 mm to 2.5 mm, and the wall thickness of the suction catheter 110 is 0.1 mm to 0.3 mm.

[0054] The suction catheter 110 may be a straight section structure as a whole, and the diameter (including the inner diameter and the outer diameter) along the axial direction thereof is uniform, that is, the flexible section 112 and the transparent section 114 may be as follows. Figure 4 As shown, they can form a linear structure by cooperating with each other. Figure 4a As shown, the transparent section 114 has a uniform diameter along the axial direction, while the proximal end of the flexible section 112 forms a constricted structure. Specifically, the inner diameter of the constricted structure gradually decreases from the proximal end to the distal end, while the distal end of the flexible section 112 has a uniform diameter along the axial direction. The inner diameter of the proximal end of the flexible section 112 is smaller than the diameter of the flow channel lumen 115. For example, the inner diameter of the flexible section 112 can be 0.9 mm to 1.6 mm. This configuration has the advantage that during the injection of irrigating fluid, the smaller diameter at the constricted structure increases fluid pressure, which helps to enhance the spraying effect of the side holes, thereby improving the cleaning of the lesion area and increasing the pathogen detection rate.

[0055] The distal end of the suction catheter 110 may also be configured as follows: Figure 5 The pre-bent structure shown. When the lesion segment is relatively straight, a suction catheter with a straight segment structure can be selected. When the lesion bronchial segment has a certain angle, a suction catheter with a pre-bent structure can be selected to easily adjust the direction of entry into the bronchus, thereby smoothly reaching the lesion location, improving the success rate and accuracy of the lavage procedure, and reducing the risk of the lavage fluid entering other bronchi, avoiding contamination of the obtained sample. The pre-bent angle a of the pre-bent structure can be between 20° and 60°, preferably 30° to 40°.

[0056] When the suction catheter 110 is pushed into the bronchus, its distal end may directly impact the bronchial wall, damaging it. Therefore, the flexible segment 112 needs to be relatively flexible, preferably made of polyurethane with a hardness of 35D. The length L1 of the flexible segment 112 can be 3 mm to 15 mm to prevent folding due to impact with the bronchial wall, and is preferably 5 mm to 10 mm.

[0057] See also Figure 6 In another embodiment of the present invention, the flexible section 112 of the aspiration catheter 110 includes multiple axially connected corrugated structures 1123, each with a wave height h of 0.2 mm to 0.4 mm and a wavelength L2 of 1 mm to 2 mm. This arrangement minimizes significant deformation even if the distal end of the flexible section 112 strikes the bronchial wall, further preventing folding.

[0058] For further information, see Figure 7In another embodiment of the present invention, at least one core wire 1121 is axially embedded in the tube wall of the flexible section 112 of the suction catheter 110. The wiring direction of the core wire 1121 is consistent with the waveform structure 1123. It is made of superelastic nickel-titanium material and can deform along with the tube wall of the flexible section 112. The diameter is 0.03mm-0.1mm. The core wire 1121 can better support the flexible section 112, further reducing the possibility of the distal end of the flexible section 112 being bent after hitting the bronchial wall. The distance between the distal end of the core wire 1121 and the distal end of the flexible section 112 is 1-3mm to avoid the distal end of the core wire 1121 directly acting on the bronchial wall.

[0059] The flexible segment 112 may have a distinct color difference from the inner wall of the bronchus. For example, the flexible segment 112 may be black or yellow, so that when observing the suction catheter 110 through the endoscope 200, the color difference can be used to quickly determine whether the distal end of the flexible segment 112 has reached the predetermined position.

[0060] The hardness of the transparent section 114 is greater than that of the flexible section 112. To achieve better recovery of irrigating fluid through negative pressure suction, the flow channel lumen 115 needs to have a larger cross-sectional area, and accordingly, the wall thickness of the suction catheter 110 needs to be as thin as possible. However, the suction catheter 110 needs to withstand the negative pressure caused by the suction process to avoid collapse, and can effectively support the force that pushes the suction catheter 110 toward the distal end to ensure that the suction catheter 110 can be pushed to the target lesion segment. Therefore, in this embodiment, the transparent section 114 is made of a nylon elastomer with a hardness of 72D, and the preferred wall thickness is 0.15mm-0.27mm.

[0061] Because the transparent section 114 is transparent, the surgeon can directly observe through the endoscope whether the flow channel of the transparent section 114 is blocked and whether the irrigation fluid in the transparent section 114 is completely recovered. In this way, the surgeon can make correct judgments and take timely measures based on the observed conditions, avoiding unnecessary harm to the patient.

[0062] As an improvement, the inner wall of the suction catheter 110 can be coated with a hydrophilic coating to make its inner wall more lubricated, promote the suction of mucus or other secretions to the outside of the body, and further avoid blockage in the tube. The material of the hydrophilic coating can be a material commonly used in the field and will not be described in detail here. The transparency of the transparent section 114 can be 60%-95%. Therefore, when the hydrophilic coating is formed on the inner wall of the transparent section 114, ultraviolet light can effectively irradiate the inner wall of the transparent section 114 to solidify the hydrophilic coating, making it easier to aspirate the irrigating fluid when the irrigating fluid is recovered by negative pressure suction.

[0063] The flexible section 112 and the transparent section 114 can be fused to each other by high temperature heat melting, for example, Figure 8The distal end surface of the transparent section 114 is fixed to the proximal end surface of the flexible section 112 by heat melting; Figure 9 The stacked hot melt shown, that is, the wall thickness of the transparent section 114 is smaller than the wall thickness of the flexible section 112, the distal end 1142 of the transparent section 114 is stacked on the proximal end 1122 of the flexible section 112, such hot melt has a large contact area and is more secure; or further, as Figure 10 The petals shown are cross-hot-melted. The distal end 1142 of the transparent section 114 and the proximal end 1122 of the flexible section 112 are respectively cut radially into a plurality of petals separated from each other, and the petals of the two are cross-stacked together in turn, and then melted into one through high-temperature heat. This heat-melting method is more uniform and firm. The petal width of the flexible section 112 is W1, and the petal width of the transparent section 114 is W2. Since the material of the flexible section 112 is polyurethane PU with a melting point of 100-120°C, and the material of the transparent section 114 is nylon elastomer with a melting point of 120°C to 200°C, that is, under the same high-temperature heat melting, the flexible section 112 is easier to melt into a liquid state than the transparent section 114. Therefore, in order to make the fusion of the two more synchronous and uniform, the ratio of the petal width W2 to W1 can be 1.2-1.8.

[0064] See also Figure 4 In this embodiment, a plurality of injection holes 1141 are provided on the tube wall at the distal end of the transparent section 114 close to the flexible section 112. As an improved embodiment, the tube wall of the flexible section 112 may also be provided with a plurality of injection holes. The shape of each injection hole 1141 may be circular, or may be elliptical, diamond-shaped or other shapes. The number of injection holes is 1-5, preferably 3. The injection holes 1141 are evenly distributed in the circumferential direction of the transparent section 114. The line connecting the centers of all the injection holes 1141 is a spiral line along the axial direction. The center distance between two adjacent injection holes 1141 may be 1-5mm. The distance between the distal end face of the flexible section 112 and the nearest injection hole 1141 may be 5mm-15mm. The area of the injection hole 1141 may be 0.28mm 2 -1.77mm 2 , preferably 0.38mm 2 -0.9mm 2 .

[0065] The lesions are often located on the inner wall of the bronchi or other bronchial branch segments. The provision of the spray hole 1141 facilitates the spraying of the lavage fluid from the spray hole 1141, thereby achieving precise cleaning of the lesion site and improving the cleaning effect. More pathogens are also sucked out along with the lavage fluid, thereby increasing the detection rate of pathogens.

[0066] When the aspiration catheter has a pre-bent configuration, see Figure 11At least one injection hole 1141 is provided on the greater bend side of the suction catheter 110. The arrow in the figure indicates the direction in which the irrigating fluid flows during the injection irrigating process. Figure 11 It can be seen that the lavage fluid will directly rush to the larger bend side of the curved part first. At this moment, the pressure on the larger bend side is relatively large. Setting the injection hole 1141 on the larger bend side is conducive to the lavage fluid being sprayed from the injection hole 1141, achieving the purpose of circumferential lavage and better cleaning the diseased segment of the bronchus.

[0067] See also Figure 1 The three-way valve 120 includes an injection cavity 121, a suction catheter connecting cavity 122, and a suction tube connecting cavity 123. The suction catheter connecting cavity 122 is connected to the proximal connector 113, and the suction tube connecting cavity 123 is connected to the suction tube 134. In clinical application scenarios, the aspirated lavage fluid or mucus will first be sucked into the flow channel cavity 115, and then collected in the liquid collection bottle 130 after passing through the suction catheter connecting cavity 122, the suction tube connecting cavity 123, and the suction tube 134. Therefore, the inner diameters of the suction catheter connecting cavity 122 and the suction tube connecting cavity 123 are both larger than the diameter of the flow channel cavity 115 as shown in the figure to prevent the three-way valve 120 from being blocked.

[0068] Please also refer to Figure 1 and Figure 12 The liquid collection bottle 130 includes a first end cap 131, a second end cap 132, and a bottle body 133. The first end cap 131 is provided with a long connecting shaft 1311 and a short connecting shaft 1312, both of which have through holes. The suction tube 134 and the negative pressure tube 135 are both open at both ends. The proximal end of the suction tube 134 is connected to the long connecting shaft 1311, and the proximal end of the negative pressure tube 135 is connected to the short connecting shaft 1312. The inner diameter of the suction tube 134 is larger than the diameter of the suction catheter flow channel 115 to prevent the suction tube 134 from being clogged by the aspirated mucus.

[0069] The end surface 1312a of the short connecting shaft 1312 is lower than the open end surface 131a of the first end cap 131. In clinical application scenarios, the negative pressure source will be activated first, and the bottle body 133 will be in a negative pressure state through the short connecting shaft 1312, so that the lavage fluid of each bronchial segment is sucked into the bottle body 133 through the suction catheter 110 and the long connecting shaft 1332. The short connecting shaft 1312 is short and is inside the first end cap 131, which can minimize the lavage fluid from being sucked from the short connecting shaft 1312 to the negative pressure source, causing the negative pressure source to be contaminated or damaged. At the same time, the long connecting shaft 1332 is set at the center of the first end cap 131, so that the recovered liquid drips from the center of the bottle body 133, thereby making the liquid splash evenly, reducing the risk of splashing liquid being sucked away by the short connecting shaft 1312, and avoiding contamination of the negative pressure source.

[0070] See also Figure 13The distal end 1331 of the bottle body 133 is open and the proximal end 1332 is closed, and both ends are provided with external threads with the same thread structure. Figure 12 and Figure 13 The first end cap 131 is provided with an internal thread that matches the external thread of the distal end 1331. The internal thread can be locked with the external thread of the distal end 1331 to sleeve the first end cap 131 onto the distal end 1331 of the bottle body 133. The second end cap 132 is provided with an internal thread that can be locked with the external thread of the proximal end 1332 to sleeve the second end cap 132 onto the proximal end 1332 of the bottle body 133.

[0071] During alveolar lavage surgery, after the lavage fluid is drawn from the bronchial segment into the bottle 133, the first end cap 131 needs to be unscrewed to disconnect the suction tube 134 from the suction catheter 110 and the negative pressure tube 135 from the negative pressure source 300. This means that the distal end of the bottle 133 connected to the first end cap 131 is open, and the lavage fluid is more likely to be contaminated during the inspection process. When using the liquid collection device provided in this embodiment, after disconnecting the suction tube 134 from the suction catheter 110 and the negative pressure tube 135 from the negative pressure source 300, the first end cap 131 and the second end cap 132 can be quickly unscrewed, the first end cap 131 can be removed from the bottle 133 and disposed of as waste, and the second end cap 132 can be screwed together with the first open end 1331 to quickly seal the opening of the distal end 1331 of the bottle 133, thereby preventing the lavage fluid in the bottle 133 from being contaminated.

[0072] In the suction catheter 110 provided in one embodiment of the present invention, see Figure 14 From the flexible section 112 to the proximal end of the transparent section 114, the wall of the transparent section 114 has a first injection hole 1114a, a second injection hole 1114b, a third injection hole 1114c, and so on. The first injection hole 1141a is closest to the proximal end of the flexible section 112, and its area is equivalent to the cross-sectional area of the flow channel lumen 115 of the suction catheter 110. The advantage of this arrangement is that it can increase the suction area of the suction catheter 110 and improve the suction efficiency. At the same time, the area of at least one injection hole is equivalent to the cross-sectional area of the flow channel lumen, that is, the suction capacity of the transparent section 114 in the circumferential direction and the axial direction are equivalent, which is conducive to the injection hole to attract the lavage fluid or mucus on the wall of the bronchial segment during the suction process, thereby improving the suction efficiency. Because the lesions are mainly on the walls of each bronchial segment, the lavage fluid or mucus attracted by the inner wall has a higher pathogen detection accuracy. As a preference, the area of the first injection hole 1141a is ±15% of the cross-sectional area of the flow channel cavity 115, because the first injection hole 1141a is located deeper in the bronchus than other injection holes, and thus produces a better suction effect.

[0073] The width of the first injection hole 1114a in the circumferential direction is smaller than the outer diameter of the suction tube 120. This arrangement has the advantage that when the suction tube 110 needs to be bent, the maximum stress during the bending process occurs at the maximum contour of the suction tube 110, ensuring sufficient support at the maximum contour to avoid bending.

[0074] During bronchoalveolar lavage, a large amount of lavage fluid may be used, requiring multiple collection bottles to complete the lavage fluid recovery. Figure 15 The liquid collection device 130 provided in one embodiment of the present invention has a drain valve 136 disposed around the periphery of the bottle 133. This drain valve 136 is connected to a drain pipe 137, the other end of which is connected to a liquid collection bucket or waste liquid bucket. The distance L between the drain valve 136 and the end surface 1321 of the second end cap 132 can be 2-10 mm. When a large amount of irrigating fluid is recovered, the drain valve 136 can be opened to drain the excess fluid into the liquid collection bucket or waste liquid bucket, eliminating the need for frequent bottle changes and reducing surgical time.

[0075] For general inflammatory lesions, the lesion segment can be cleansed with an appropriate lavage fluid. However, for bronchial tumors, radioactive particles are clinically required for treatment. The standard radioactive particle diameter is 0.8 mm and the length is 5 mm.

[0076] See also Figure 16 The aspiration catheter provided in one embodiment of the present invention is suitable for use in radioactive particle therapy for bronchial tumors. Its flexible section 112 has a tapered structure, meaning its inner diameter is smaller than the diameter of the flow channel lumen 115. The inner diameter of the flexible section 112 can be 0.3-0.7 mm, allowing for use with radioactive particles 500. The radioactive particles 500 can pass through the flow channel lumen 115 and enter the edge of the flexible section 112. Because the inner diameter of the flexible section 112 is smaller than the outer diameter of the radioactive particles 500, the flexible section 112 serves to limit the position of the radioactive particles 500, allowing them to be pushed to the target location for treatment.

[0077] If the diameter of the flow channel 115 of the transparent section 114 is too large, multiple radioactive particles will overlap within the flow channel 115, resulting in inconsistent accumulation patterns and making it difficult to determine the radiation effect, thus affecting the therapeutic effect. Therefore, the diameter of the flow channel 115 can be 0.9 mm to 1.5 mm to ensure that multiple particles do not overlap within the flow channel 115.

[0078] In order to arrange the radioactive particles in an orderly and planned manner and achieve precise treatment, in the suction catheter 110 provided in one embodiment of the present invention, as shown in FIG. Figure 17As shown, the transparent section 114 includes multiple pairs of equally spaced protrusions 1142 arranged on its inner wall. Each pair of protrusions 1142 is symmetrical about the axis. The cavity diameter A defined by each pair of protrusions 1142 is 0.65 mm to 0.75 mm, meaning the difference between the outer diameter of the radioactive particle and the diameter A of the protrusion is 0.05 mm to 0.15 mm. The distance L4 between two adjacent protrusions 1142 is 10 mm to 15 mm, and the two adjacent pairs of protrusions 1142 form a retaining groove. During use, the sheath core push rod 600 can be used to push the radioactive particle 500 into the retaining groove from the direction of the water inlet of the flow channel cavity 115. Even if the protrusions 1142 are encountered during the pushing process, due to the interference fit between the radioactive particle 500 and the protrusions 1142 and the fact that the protrusions 1142 are made of a polymer material with a certain degree of elasticity, the radioactive particle 500 can be pushed through the protrusions 1142 and into the desired retaining groove with a gentle push.

[0079] Further, as a preferred embodiment, see Figure 18 The protrusion 1142 has a wedge-shaped cross-section along the axial direction, and the angle between the protrusion 1142 and the axial direction is acute angle β, which is 30°-60°. This facilitates the sheath core push rod 600 to push the radioactive particles 500 through the protrusion 1142. The protrusion 1142 forms an obtuse angle β opposite to the axial direction, thereby preventing the patient from coughing severely and causing the radioactive particles 500 to move proximally.

[0080] During alveolar lavage, when the bronchoscope is pushed distally along the bronchus, the opening of the bronchial branch in front may be elliptical, with the opening area larger than the cross-sectional area of the bronchoscope and the short axis of the ellipse smaller than the diameter of the bronchoscope, resulting in the bronchoscope being unable to pass through the bronchial branch.

[0081] For this, see Figure 19 In one embodiment of the present invention, at least one reinforcing wire 1142 is embedded in the tube wall of the transparent section 114 of the suction catheter 110 along the axial direction. The reinforcing wire 1142 is a superelastic nickel-titanium wire, which plays a good supporting role for the transparent section 114. When encountering the situation described in the previous paragraph, the bronchoscope can be pushed to the elliptical opening of the bronchial branch, and the suction catheter 110 enters the bronchus through the working channel of the bronchoscope. Since the diameter of the suction catheter 110 is relatively small compared to the diameter of the bronchoscope, it can pass through the bronchial branch with the elliptical opening more smoothly. At this time, the transparent section 114 plays the role of guiding the bronchoscope, and the bronchoscope can be pushed toward the distal end along the transparent section 114. In addition, the reinforcing wire 1142 in the transparent section 114 can provide sufficient support, so that the bronchoscope can enter the desired bronchial branch when it is pushed to the elliptical opening, making full preparations for the subsequent surgery.

[0082] In addition, the reinforcing wire 1142 may be Figure 20As shown, the flexible segment 112 is integrally formed with the core wire 1121, thereby preventing the intersection of the two from buckling due to support. In clinical applications, the transparent segment 114 requires greater support to support the bronchoscope. Therefore, the diameter of the core wire 1121 of the flexible segment 112 is smaller than the diameter of the reinforcing wire 1142 of the transparent segment 114. As a preferred embodiment, the diameter ratio of the core wire 1121 to the reinforcing wire 1142 can be 0.5-0.8.

[0083] See Figure 21 Compared with the first embodiment, the suction catheter provided in the eighth embodiment of the present invention includes not only the flexible section 112 and the transparent section 114 located at the distal end, but also a connecting section 116 located between the transparent section 114 and the flexible section 112 and the two sections are fixedly connected and communicated with the two sections. The connecting section 116 and the transparent section 114 are made of the same material, but the colors are different. The connecting section 116 and the flexible section 112 are made of different materials and the same color. In this way, the connecting section 116 and the transparent section 114 can be used as follows Figure 8 The hot melt method shown in the figure can achieve a firm connection between the two without the need for Figure 9 Or overlapping hot melt or petal melting as shown in 10; at the same time, the connecting section 116 and the flexible section 112 can be used as Figure 9 or Figure 10 The overlapping hot-melt or petal-shaped hot-melt bonding method shown above is used to cross and firmly bond with each other, and the overlapping parts of the two will not change in color, thereby avoiding various color differences in the overlapping parts after hot-melt, which may cause doctors to make misjudgments.

[0084] The above describes the alveolar lavage device provided by the present invention in detail. It is understood that the above description does not limit the scope of the present invention. All equivalent structural changes made based on the contents of the present specification and drawings, or direct or indirect application in other related technical fields within the scope of the present invention are included in the scope of patent protection of the present invention.

Claims

1. A pulmonary alveolar lavage device, characterized in that: The invention comprises a suction catheter for entering the bronchus through the insertion tube of an endoscope for alveolar lavage, and an ultrasound probe for entering the bronchus through the suction catheter; the suction catheter comprises an opaque flexible section at the distal end and a transparent section connected to the proximal end of the flexible section, the hardness of the transparent section is greater than the hardness of the flexible section, the distal end of the flexible section comprises a plurality of waveform structures connected end to end in axial direction, the wave height of each waveform structure is 0.2mm-0.4mm, and the wavelength is 1mm-2mm, at least one superelastic core wire with a wiring direction consistent with the plurality of waveform structures is embedded in the tube wall of the flexible section, the distal end of the core wire is aligned with the distal end of the flexible section The distance is 1mm-3mm, the suction catheter is a straight equal-diameter structure, and its tube wall is provided with multiple injection holes; or the distal end of the suction catheter has a pre-bent structure, and the large bend side of the pre-bent structure is provided with at least one injection hole; or the proximal end of the flexible segment is a tapered structure, and the inner diameter of the tapered structure gradually decreases from the proximal end to the distal end; the area of the injection hole closest to the proximal end of the flexible segment is ±15% of the cross-sectional area of the flow channel cavity of the alveolar lavage device. When the distal end of the suction catheter is away from the visible range of the endoscope, the ultrasound probe is passed through the suction catheter into the bronchus, and the bronchial morphology is observed by the image formed by the ultrasound of the ultrasound probe.

2. The alveolar lavage device according to claim 1, wherein The inner wall of the transparent section is provided with a hydrophilic coating, and the transparency of the transparent section is 60%-95%.

3. The alveolar lavage device according to claim 1, wherein: The distal end of the transparent segment is stacked with the proximal end of the flexible segment; or the distal end of the transparent segment and the proximal end of the flexible segment both include multiple petals spaced apart from each other in the radial direction, and the multiple petals of the transparent segment and the multiple petals of the flexible segment are cross-stacked one by one.

4. The alveolar lavage device according to claim 1, wherein The inner wall of the transparent section is provided with a plurality of pairs of protrusions spaced apart along the axial direction, the two protrusions in each pair of protrusions are axially symmetrical, and the inner diameter of the flexible section is smaller than the inner diameter of the transparent section.

5. The alveolar lavage device according to claim 1, wherein: The suction catheter also includes a connecting section, the two ends of which are respectively fixed to and communicate with the flexible section and the transparent section. The connecting section and the transparent section are made of the same material but different colors, and the connecting section and the flexible section are made of different materials but the same color.

6. The alveolar lavage device according to claim 1, wherein: The alveolar lavage device also includes a three-way valve having an injection cavity, a suction catheter connecting cavity and a suction tube connecting cavity. The suction catheter connecting cavity is adapted to be plugged into the proximal end of the transparent segment, and the suction tube connecting cavity is adapted to be plugged into the suction tube. The inner diameters of the suction catheter connecting cavity and the suction tube connecting cavity are both larger than the diameter of the flow channel cavity of the suction catheter.

7. The alveolar lavage device according to claim 6, characterized in that: The alveolar lavage device also includes a liquid collection bottle, which includes a bottle body with a distal opening and a proximal closed end, a distal end cover and a proximal end cover, wherein the distal end cover is detachably connected to the distal end of the bottle body through a thread; the proximal end cover is detachably connected to the proximal end of the bottle body through a thread, and is adapted to be detachably connected to the distal end of the bottle body through a thread, and the suction tube is adapted so that its two ends are respectively connected to the suction tube connecting cavity and the bottle body.

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