Irrigation catheter

Abstract

The application provides a lavage catheter, which comprises a handle assembly and a catheter assembly. The handle assembly comprises a shell and a movable assembly. The movable assembly is movably arranged in the shell, so that the movable assembly comprises a first state and a second state relative to the shell. The catheter assembly comprises a catheter tube and a pop-up unit. The catheter tube is provided with an opening at a distal end for communication with the outside. The pop-up unit comprises a connecting wire and a pop-up part. The proximal end of the connecting wire is connected to the movable assembly, and the distal end of the connecting wire is connected to the pop-up part. When the movable assembly is in the first state, the connecting wire is in tension, and the pop-up part is received in the catheter tube. When the movable assembly is in the second state, the connecting wire is relaxed, and the pop-up part is popped out of the opening. The lavage catheter provided by the application can make the pop-up part pop out of the opening, so as to keep a certain space gap between the sub-segment bronchial wall and the opening, and prevent the sub-segment bronchial wall from closely adhering to the catheter tube under negative pressure to block the opening and cause difficulty in pumping the lavage liquid.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to an irrigation catheter. Background Technology

[0002] Bronchoalveolar lavage is a procedure that involves injecting physiological saline into the bronchi and alveoli using a bronchoscope and then immediately aspirating it to collect the effective fluid from the alveolar surface for examination of its cellular components and soluble substances. Clinically, it is used for the diagnosis and differential diagnosis of various lung diseases, such as alveolitis, pulmonary fibrosis, asbestosis, lung cancer, and pulmonary alveolar proteinosis, as well as for studying the etiology, pathogenesis, and evaluation of treatment efficacy in lung diseases.

[0003] Currently, irrigation catheters are typically delivered to the target bronchus via a bronchoscope, where saline solution is injected through the inlet. After irrigation, the catheter is switched to aspiration mode, and a negative pressure device is activated to complete aspiration, thus completing one irrigation and aspiration cycle. However, due to the limited size of the bronchoscope, it cannot reach lower-level bronchi. The irrigation catheter can only extend from the bronchoscope towards the subsegment. Since the bronchial subsegments are narrow, when the irrigation catheter is in negative pressure aspiration mode, the bronchial wall can easily adhere to the aspiration opening at the distal end of the catheter, preventing the aspiration of irrigation fluid. This results in a low recovery rate of the irrigation fluid and may lead to fluid retention in the trachea, causing complications such as hypoxemia and fever. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide an irrigation catheter, which addresses the defect in the prior art where negative pressure suction can easily cause the bronchial wall to adhere to the opening at the distal end of the catheter body for fluid suction under negative pressure, thus making suction difficult.

[0005] The technical solution adopted by this invention to solve its technical problem is:

[0006] An embodiment of the present invention provides an irrigation catheter, including a handle assembly and a catheter assembly. The handle assembly includes a housing and a movable component, the movable component being movably located within the housing such that the movable component has a first state and a second state relative to the housing. The catheter assembly includes a catheter body and an ejection unit. The distal end of the catheter body has an opening communicating with the outside. The ejection unit includes a connecting wire and an ejection part. The proximal end of the connecting wire is connected to the movable component, and the distal end of the connecting wire is connected to the ejection part. When the movable component is in the first state, the connecting wire is tensioned, and the ejection part is retracted into the catheter body. When the movable component is in the second state, the connecting wire is relaxed, and the ejection part ejects from the opening.

[0007] In one embodiment of the present invention, the irrigation catheter further includes a catheter head fixed to the distal opening of the catheter body, the pop-out portion includes a connecting section and a pop-out section, the distal end of the connecting wire is connected to the proximal end of the pop-out section, one end of the connecting section is fixed to the proximal end of the catheter head, the other end of the connecting section is connected to the distal end of the pop-out section, and the pop-out section and the opening are radially opposite each other.

[0008] In one embodiment of the present invention, the catheter assembly further includes a fastener body, wherein the connecting segment is wound around the fastener and fixed together within the catheter head.

[0009] In one embodiment of the present invention, the pop-out segment includes a convex elastic wire.

[0010] In one embodiment of the present invention, the opening includes a first opening and a second opening, and a blocking portion is included between the first opening and the second opening, the blocking portion blocking part of the ejection segment outside the catheter tube.

[0011] In one embodiment of the present invention, a receiving groove is provided on the outer side of the blocking part.

[0012] In one embodiment of the present invention, the pop-out unit further includes an elastic connecting portion and a limiting portion fixed to the distal end of the catheter body. The limiting portion is located on the proximal side of the pop-out portion, and the pop-out portion and the limiting portion are connected through the elastic connecting portion. The distal end of the connecting wire passes through the limiting portion and the elastic connecting portion and is connected to the proximal end of the pop-out portion. In the first state, the distal end of the pop-out portion is close to or flush with the distal port of the catheter body.

[0013] In one embodiment of the present invention, the pop-out portion includes a deformable portion and anchors. The deformable portion is woven from a material with a shape and an anchor, and two anchors are located at both ends of the deformable portion to close the deformable portion.

[0014] In one embodiment of the present invention, the anchor includes an anchor plate, the anchor plate on the proximal side including a plurality of through holes, and the anchor plate on the distal side being annular.

[0015] In one embodiment of the present invention, the maximum width of the anchor plate is less than the inner diameter of the conduit body, and the maximum radial dimension of the deformable part in its natural expansion state is greater than the outer diameter of the conduit body.

[0016] The irrigation catheter provided by this invention connects the movable component to the distal ejector portion via a connecting wire. The tension and relaxation of the connecting wire are controlled by switching between a first state and a second state, thereby retracting the ejector portion into the catheter body or ejecting it from the distal end. In the second state, the ejector portion ejects from the opening, thereby creating a certain spatial gap between the subsegment bronchial wall and the opening. This prevents the subsegment bronchial wall from tightly adhering to the catheter body under negative pressure, thus blocking the opening and making it difficult to aspirate the irrigated fluid. Attached Figure Description

[0017] The present invention will be further described below with reference to the accompanying drawings and embodiments. In the accompanying drawings:

[0018] Figure 1 This is a schematic diagram of the structure of an irrigation catheter according to an embodiment of the present invention;

[0019] Figure 2 yes Figure 1 Enlarged view of point A in the middle;

[0020] Figure 3 yes Figure 1 Exploded view (connecting wires omitted);

[0021] Figure 4 yes Figure 1 The shown is a cross-sectional view of the irrigation catheter in its first state.

[0022] Figure 5 yes Figure 4 Enlarged view of point B in the middle;

[0023] Figure 6 yes Figure 4 Enlarged view of point C in the middle;

[0024] Figure 7 yes Figure 1 The shown is a cross-sectional view of the irrigation catheter in its second state.

[0025] Figure 8 yes Figure 7 Enlarged view at point D;

[0026] Figure 9 This is a cross-sectional view of the distal end of the catheter assembly in a first state according to another embodiment of the present invention;

[0027] Figure 10 This is a cross-sectional view of the distal end of the catheter assembly in a second state according to another embodiment of the present invention;

[0028] Figure 11 This is a schematic diagram of the structure of an irrigation catheter system according to an embodiment of the present invention;

[0029] Figure 12 yes Figure 11 Enlarged view at point E in the middle;

[0030] Figure 13 This is a cross-sectional view of the irrigation catheter in a first state according to another embodiment of the present invention;

[0031] Figure 14 yes Figure 13 Enlarged view at point F;

[0032] Figure 15 This is a cross-sectional view of the irrigation catheter in a second state according to another embodiment of the present invention;

[0033] Figure 16 yes Figure 15 Enlarged view of point G in the middle;

[0034] Figure 17 This is a schematic diagram of the structure of the pop-out part in its naturally expanded state according to another embodiment of the present invention. Detailed Implementation

[0035] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0036] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or state relationship based on the orientation or state relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0037] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0038] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0039] In this application, "proximal" refers to the end closer to the operator, "proximal side" refers to the side closer to the operator, "distal" refers to the end farther from the operator, and "distal side" refers to the side farther from the operator. "Axial" refers to the direction parallel to the line connecting the distal and proximal centers of the medical device, and "radial" refers to the direction perpendicular to the aforementioned axial direction.

[0040] Example 1

[0041] The irrigation catheter 10 provided by this invention is used for bronchoalveolar lavage. For example... Figure 1-4 Combination Figure 7 As shown, during use, the irrigation catheter 10 can switch the position of the movable component 113 of the handle relative to the housing to achieve either a first state where the first channel is connected to the catheter channel or a second state where the second channel is connected to the catheter channel. When the movable component 113 is in the first state, the irrigation catheter 10 can perform irrigation operations. When the movable component 113 is in the second state, the irrigation catheter 10 can perform suction operations, thereby satisfying the irrigation and suction purposes of the irrigation catheter 10.

[0042] like Figure 1-4 Combination Figure 7 As shown, the irrigation catheter 10 includes a handle assembly 11 and a catheter assembly 12. The handle assembly 11 includes a first housing 111, a second housing 112, and a movable component 113. The proximal end of the first housing 111 has an internal thread, and the distal end of the second housing 112 has an external thread. The first housing 111 is located on the distal side of the second housing 112 so that the internal thread at the proximal end of the first housing 111 and the external thread at the distal end of the second housing 112 are connected by internal and external threads. The first housing 111 and the second housing 112 are both axially connected and form cavities within the housings. A portion of the movable component 113 is movably located within the cavity and can move axially to achieve a first state or a second state relative to the first housing 111 and the second housing 112.

[0043] like Figure 3As shown in Figure 4, the distal end of the first housing 111 has a communication port 1112 that communicates with the conduit assembly 12. Near the distal end of the first housing 111, a non-axial injection port 1111 extends. The injection port 1111 can be perpendicular to the axial direction or form an acute angle with the extension line of the communication port 1112 axially toward the proximal end and is located above the first housing 111, so that the injected liquid in the first state tends to flow along the first channel T1 toward the conduit assembly 12. In this embodiment, the inner cavity of the first housing 111 includes an axial channel that matches the shape of the communication portion 11311. This channel allows the communication portion 11311 of the mandrel 1131 to move axially so that the mandrel 1131 blocks the injection port 1111 or connects the injection port 1111 to the conduit assembly 12. The first housing 111 also includes a first inner conical surface 1113 that matches the first outer conical surface 113122. When the handle assembly 11 is in the first state, the connecting portion 11311 at the proximal end of the connection between the injection port 1111 and the inner cavity of the first housing 111 forms a first channel T1, which extends from the injection port 1111 through the axial channel of the first housing 111 to the connecting port 1112. Figure 4 The dashed path T1 is shown, and the first channel is connected to the conduit assembly 12. At this time, the second outer conical surface 113123 of the mandrel 1131 abuts against and squeezes the sealing ring with the second inner conical surface 1123 of the second housing 112, thereby blocking the connection between the negative pressure port 1121 and the connecting port 1112. Figure 3-4 As shown.

[0044] like Figure 3-4 Combination Figure 7 As shown, a pressure relief port 1122 is provided at the proximal end of the second housing 112, and a negative pressure port 1121 extends non-axially from the distal end near the second housing 112. In the first state, the pressure relief port 1122 communicates with the negative pressure port 1121 to allow the negative pressure port 1121 to communicate with the outside and achieve pressure relief. A groove for fixing a compression spring 1133 is also provided at the proximal end of the second housing 112. The distal end of the compression spring 1133 is embedded in the groove, and the compression spring 1133 is arranged around a portion of the end cap 1132. This allows the distal end of the end cap 1132 to be threadedly connected to the spindle 1131, while the end cap 1132 is also elastically connected to the second housing 112, allowing the end cap 1132 to move axially relative to the second housing 112. In this embodiment, the negative pressure port 1121 is perpendicular to the second housing 112 and located below it, so that the liquid drawn in the second state is collected in the collector 102 along the second channel through the negative pressure port 1121. Figure 11 As shown. Combined with Figure 4 and Figure 7 As shown, the second housing 112 also includes a second inner conical surface 1123 located at the distal end and a third inner conical surface 1124 located at the proximal end, so that when the handle assembly 11 is in the first state, as Figure 4 Combination Figure 1 As shown, the second inner conical surface 1123 can abut against and compress the sealing ring with the second outer conical surface 113123 of the spindle 1131 to seal, thereby sealing the spindle 1131 and the second housing 112 to block the passage between the negative pressure port 1121 and the connecting port 1112. At the same time, the third inner conical surface 1124 and the third outer conical surface 113221 are spaced flat to form a pressure relief port 1122; when the handle assembly 11 is in the second state, as Figure 7 As shown, the third inner conical surface 1124 and the third outer conical surface 113221 abut and compress the sealing ring to seal, thereby blocking the passage between the negative pressure port 1121 and the pressure relief port 1122. At the same time, the first inner conical surface 1113 of the first housing 111 abuts and compresses the sealing ring 1134 at the corresponding position to deform and cooperate, thereby maintaining the sealing performance between the mandrel 1131 and the first housing 111. Meanwhile, the mandrel 1131 blocks the passage between the injection port 1111 and the connecting port 1112. The second inner conical surface 1123 and the second outer conical surface 113123 of the mandrel 1131 are spaced parallel to each other to connect the passage between the negative pressure port 1121 and the connecting port 1112.

[0045] like Figure 3 As shown, the active component 113 includes a spindle 1131, an end cap 1132, a compression spring 1133, and multiple sealing rings 1134.

[0046] like Figure 3-4 Combination Figure 7 As shown, the mandrel 1131 is located within the cavity formed by the first housing 111 and the second housing 112. From its distal end to its proximal end, the mandrel 1131 sequentially includes a connecting portion 11311, a switching portion 11312, and a connecting portion 11313. The connecting portion 11311 is elongated and has a connecting hole 113111 along its axial direction. The switching portion 11312 is spindle-shaped and has a through hole 113121 in its center, which extends radially and communicates with the cavity. The connecting hole 113111 extends proximally and communicates axially with the through hole 113121. Figure 7 As shown, the connecting hole 113111 and the through hole 113121 together form a channel connecting the negative pressure port 1121 and the connecting port 1112. The switching part 11312 includes a first outer conical surface 113122 and a second outer conical surface 113123, which are located on opposite radial sides of the through hole 113121, with the first outer conical surface 113122 located at the distal end and the second outer conical surface 113123 located at the proximal end. The first outer conical surface 113122 includes a first groove 113124 for receiving a sealing ring 1134, and the second outer conical surface 113123 includes a second groove 113125 for receiving a sealing ring 1134. The proximal end of the connecting part 11313 is connected to the end cap 1132, and the proximal end is provided with an external thread.

[0047] like Figure 3-4 Combination Figure 7 As shown, the end cap 1132 includes, from distal to proximal end, an extension 11321, a sealing portion 11322, and a brim portion 11323. The distal end of the sealing portion 11322 extends toward the distal end to form the extension 11321. The extension 11321 includes a blind hole for accommodating a portion of the connecting portion 11313, and the blind hole is provided with an internal thread. The extension 11321 and the connecting portion 11313 of the spindle 1131 are internally threaded together in the blind hole at the distal end of the end cap 1132. The proximal end of the sealing portion 11322 is connected to the brim portion 11323. The sealing portion 11322 includes a third outer conical surface 113221 and a buffer section 113222. The third outer conical surface 113221 includes a third groove 113223 for accommodating the sealing ring 1134, and the third outer conical surface 113221 is used to abut against and press the sealing ring at the corresponding position of the third inner conical surface 1124 of the second housing 112 to seal (external force pressing) to block the pressure relief port 1122. The buffer section 113222 is used to connect the sealing part 11322 and the brim part 11323, and the brim part 11323 surrounds the proximal end of the second housing 112.

[0048] The second housing 112 has a fourth groove 1125 near the external thread to accommodate the sealing ring 1134. The threaded connection between the first housing 111 and the second housing 112 is also sealed by compressing the sealing ring 1134 to increase the housing's sealing performance. Figure 3 Combination Figure 7 As shown. Similarly, in this embodiment, each outer conical surface of the mandrel 1131 abuts against and cooperates with each inner conical surface of the first housing 111 and the second housing 112 through each groove and the sealing ring 1134 in the groove to increase the sealing performance, ensure the negative pressure environment when the second channel is connected, and prevent suction difficulties caused by poor sealing performance.

[0049] The sealing ring 1134 can be made of rubber material, and the compression of the sealing ring by the contact between the inner and outer conical surfaces can achieve good sealing performance.

[0050] Figure 4 The relative position of the spindle 1131 of the handle assembly 11 in this embodiment with respect to the housing in the first state is shown. Figure 3As shown, when the handle assembly 11 is in the first state, the compression spring 1133 is in a pre-compressed state (pre-compressed state means a small amount of compression relative to the natural state of the compression spring 1133). This ensures that the compression spring 1133 always has a proximal force on the end cap 1132 to hold the compression spring 1133 between the end cap 1132 and the second housing 112. Simultaneously, it maintains pressure contact between the second outer conical surface 113123 of the spindle 1131 and the second inner conical surface 1123 of the second housing 112, while also compressing the corresponding sealing ring to maintain better sealing. At this time, the distal end of the spindle 1131 avoids the injection port 1111 to ensure that the injection port 1111 forms a first channel with the interior of the first housing 111 and connects to the conduit body 121 through the connecting port 1112. Figure 4 As shown, the first outer conical surface 113122 of the mandrel 1131 is parallel to the first inner conical surface 1113 of the first housing 111, and the distal end of the mandrel 1131 is located on the proximal side of the connection between the injection port 1111 and the inner cavity of the first housing 111, so that the mandrel 1131 avoids the injection port 1111, thereby forming a first channel together with the axial channel of the first housing 111 and communicating with the conduit assembly 12. At this time, the second outer conical surface 113123 of the mandrel 1131 abuts against the second inner conical surface 1123 of the second housing 112 and is squeezed and engaged under the pre-compression rebound force of the compression spring 1133 on the movable assembly 113 towards the proximal end, thereby sealing the mandrel 1131 and the second housing 112 to block the communication between the negative pressure port 1121 and the communication port 1112. Simultaneously, the third inner conical surface 1124 and the third outer conical surface 113221 are parallel to each other, forming a pressure relief port 1122 that communicates with the negative pressure port 1121, thereby allowing the negative pressure port 1121 to communicate with the outside world for pressure relief. In the first state, physiological saline can be injected through the injection port 1111. The injected physiological saline is injected into the bronchoalveolar cavity through the first channel and the conduit assembly 12 to achieve fluid irrigation.

[0051] Figure 7 This illustrates the relative position of the mandrel 1131 with respect to the housing in the second state, in conjunction with... Figure 3-4 As shown, based on the first state, pressing the end cap 1132 can drive the spindle 1131 to move from... Figure 4 The first state shown is formed by moving axially towards the distal end. Figure 7In the second state shown, when the handle assembly 11 is in the second state, the compression spring 1133 is in a compressed state (the compression state in the second state is an incompletely compressed state, that is, the spindle 1131 has moved to the farthest limit position of movement towards the distal end before the maximum deformation of the compression spring 1133 is reached. At this time, the spindle 1131 has blocked the injection port 1111 and the first outer conical surface 113122 of the spindle 1131 abuts against the first inner conical surface 1113 of the first housing 111. The sealing performance is improved by using the inclined surface abutment. The sealing performance can be further improved by combining it with the compression of the sealing ring. That is, on the basis of the inclined surface abutment of each inner and outer conical surface, the sealing performance of the first state and the second state is improved by the compression of the sealing ring). This makes the connecting part 1 of the spindle 1131... 1311 Seals the side injection port 1111. At the same time, the first outer conical surface 113122 of the mandrel 1131 and the first inner conical surface 1113 of the first housing 111 are in close contact to maintain the sealing between the mandrel 1131 and the first housing 111. The second outer conical surface 113123 of the mandrel 1131 and the second inner conical surface 1123 of the second housing 112 are parallel to each other to connect the negative pressure port 1121 and the through hole 113121, thereby connecting the passage between the negative pressure port 1121 and the conduit assembly 12 (i.e. forming the second channel T2). The third inner conical surface 1124 of the second housing 112 abuts against the third outer conical surface 113221 of the end cap 1132 and squeezes the sealing ring at the corresponding position to seal the pressure relief port 1122, maintain the sealing and prevent pressure relief. At this point, a second channel is formed, starting from the connecting port 1112, passing through the connecting hole 113111, the through hole 113121, and ending at the negative pressure port 1121. Figure 7 The path T2 shown (combined) Figure 4 (label), and the second channel is connected to the conduit of the catheter assembly 12. The negative pressure port 1121 can be connected to a negative pressure device to aspirate the physiological saline after irrigation.

[0052] By pressing the end cap 1132 to further press the compression spring 1133, the end cap 1132 pushes the spindle 1131 to move axially from the proximal end to the distal end, and the spindle 1131 moves from the first state to the second state; when the force of pressing the end cap 1132 is removed, the compression spring 1133 returns from the compressed state to the pre-compressed state, and the spindle 1131 automatically returns from the second state to the first state along with the end cap 1132, thereby realizing the rapid switching of the spindle 1131 relative to the housing between the first state and the second state.

[0053] To ensure that the compression spring 1133 is in a pre-compressed state when the end cap 1132 is held in the first state, a protruding buckle 1126 blocking the end cap 1132 can be provided circumferentially at the proximal end of the second housing 112. A reverse buckle 113231 corresponding to and matching the protruding buckle 1126 is provided at the distal end of the brim 11323 of the end cap 1132. The reverse buckle 113231 extends inward from the distal end of the brim 11323 to cooperate with the protruding buckle 1126 to block and prevent the compression spring 1133 from returning to its uncompressed natural state without external force, thus keeping the compression spring 1133 in a pre-compressed state. Figure 4 and Figure 6 As shown.

[0054] like Figure 1-5 Combination Figure 7-8 As shown, the catheter assembly 12 includes a catheter body 121 and an ejection unit. The ejection unit includes a connecting wire 123 and an ejection part 125. The distal end of the catheter body 121 has an opening 124 communicating with the outside. The catheter body 121 includes a hollow tube connecting the proximal and distal ends. The proximal end of the catheter body 121 is connected to the communication port 1112 at the distal end of the handle assembly 11 by means of adhesive bonding or threaded connection, so that the hollow tube of the catheter assembly 12 communicates with the communication port 1112.

[0055] In this embodiment, the irrigation catheter 10 further includes a catheter head 122, which is fixed to the distal opening of the catheter body. The proximal end of the connecting wire 123 is connected to the mandrel 1331, and the distal end of the connecting wire 123 is connected to the ejector portion 125. The ejector portion 125 includes a connecting section 1251 and an ejector section 1252 sequentially from the distal end to the proximal end. The distal end of the connecting section 1251 is fixed to the proximal end of the catheter head 122, and the proximal end of the connecting section 1251 is connected to the distal end of the ejector section 1252. The distal end of the connecting wire 123 is connected to the proximal end of the ejector section 1252. In this embodiment, the proximal end of the catheter head 122 is fixed to the distal port of the catheter body 121 by adhesive to fix the connecting section 1251 of the ejector portion 125. The catheter head 122 can be cured and molded together with the connecting section 1251 in a mold using liquid silicone. In other embodiments, the connecting segment 1251 can be wrapped around a solid component 1253 and placed in a mold, then liquid silicone can be poured into the mold and cured to increase the fixing reliability of the connecting segment 1251 and the conduit head 122, such as... Figure 5 and Figure 8 As shown.

[0056] In this embodiment, such as Figure 2 Combination Figure 5 , Figure 8As shown, an opening 124 communicating with the hollow channel inside the catheter body 121 is provided on the side of the distal end near the proximal end of the catheter head 122. The ejector portion 125 is integrally formed with the connecting wire 123 and is located near the proximal end of the catheter head 122. The position of the opening 124 corresponds radially to the position of the ejector portion 1252 so that the ejector portion 1252 can eject radially along the opening 124. Specifically, the ejector portion 1252 is a convex elastic wire passing through the first and second openings. In the first state, the protruding part adheres to the catheter body 121 and is blocked by the blocking part on the outside of the catheter body to facilitate ejection. In other embodiments, the position of the opening may also correspond axially to the position of the ejector portion so that the ejector portion can eject axially. Regardless of the direction in which the opening and the ejector portion correspond, as long as the ejector portion can eject from the catheter body along the opening to support the bronchial wall, it is acceptable.

[0057] Two openings are provided for the ejector segment 1252 to eject from the opening into the catheter body 121. The opening 124 includes a first opening 1241 near the proximal end of the catheter head 122 and a second opening 1242 spaced apart from the first opening. In this embodiment, the size of the opening is larger than the diameter of the ejector segment 1252. This opening also serves as a fluid inlet to allow the catheter body 121 to communicate with the outside for injection or aspiration. The size and number of openings are only required to ensure that the flow of liquid is not affected after the ejector segment 1252 passes through the opening 124. In other embodiments, a third opening 1243 is also provided on the side wall of the catheter body between the first opening 1241 and the second opening 1242 to allow for smoother liquid flow, such as... Figure 2 As shown.

[0058] like Figure 8 As shown, the pop-out section 1252 is made of a shape memory metal wire through heat treatment. The two ends of the pop-out section 1252 are respectively inserted into the hollow tube of the conduit body 121 from the outside of the conduit body 121 through the first opening 1241 and the second opening 1242, and are respectively formed into a whole wire together with the connecting section 1251 and the connecting wire 123.

[0059] In other implementations, such as Figure 10-11 As shown, the portion of the conduit body between the first opening 1241 and the second opening 1242 forms a blocking portion 1244. The blocking portion 1244 can block part of the ejected section 1252 outside the conduit body 121. A receiving groove 1245 is provided on the outer side of the blocking portion 1244. When the mandrel is in the first state relative to the housing, the receiving groove 1245 can accommodate the exposed ejected section 1252, preventing the exposed ejected section from being higher than the outer surface of the conduit body 121, reducing the contact between the ejected section and the bronchial wall during delivery, and reducing the risk that may be brought to the bronchial wall during delivery.

[0060] The ejector section 1252 is made of a shape-memory material, such as a highly elastic nickel-titanium alloy or stainless steel. When the ejector section 1252 is in its natural state (when the handle assembly is in its second state), as... Figure 8 As shown, the linear protrusion of the pop-out section 1252 extends outward from the outer wall of the catheter body 121 and forms a space between them. This allows the pop-out section 1252 to protrude outward from the catheter body 121 to support the bronchial wall when the handle assembly is in the second state. This prevents the bronchial wall from sticking tightly to the side wall of the catheter body under negative pressure aspiration, thus blocking the opening and preventing the aspiration of the physiological saline after irrigation, which would hinder the diagnostic or drug administration. At the same time, it prevents complications such as hypoxemia or fever caused by the retention of irrigation fluid in the bronchus.

[0061] like Figure 4-5 As shown, when the mandrel 1131 is in the first state relative to the housing, the first channel is connected (e.g., Figure 4 As shown in path T1), at this time, the compression spring is in a pre-compressed state, and the compression spring has a spring force on the spindle toward the proximal end. The connecting wire 123 is in a taut state and pulls the pop-out section 1252 from its natural state to be tightly attached to the outer wall of the catheter body 121. At this time, liquid can be injected into the bronchus through the injection port along the first channel and the hollow pipe of the catheter body 121 to the opening.

[0062] When the compression spring is pressed to the compressed state, so that the spindle is in the second state relative to the housing, as follows: Figure 7-8 As shown, the second channel is now connected (as shown). Figure 7 As shown in path T2), due to the deformation of the compression spring along the axial direction, the connecting wire 123 is relaxed, and the pop-out section 1252 loses the constraint of the tension of the connecting wire 123. It will naturally expand and deform towards its natural state, so that the pop-out section 1252 protrudes relative to the catheter body 121. Thus, even under negative pressure, the pop-out section 1252 can support the bronchial wall to maintain a certain gap between the bronchial wall and the catheter body 121. This prevents the bronchial wall from sticking tightly to the side wall of the catheter body under negative pressure suction, thereby blocking the opening and making it impossible to aspirate the physiological saline after irrigation, thus failing to achieve the purpose of diagnosis or drug administration. At the same time, it prevents complications such as hypoxemia or fever caused by the retention of irrigation fluid in the bronchus.

[0063] In other embodiments, in the first state, a groove may be formed at the position where the catheter body 121 and the pop-out section 1252 are attached to accommodate the pop-out section 1252, so that in the first state, the pop-out section 1252 does not protrude from the outer wall of the catheter body 121.

[0064] The silicone used in this embodiment is medical-grade silicone, which has good biocompatibility, is non-irritating, non-toxic, non-allergenic to human tissues, and has very little rejection reaction by the body; it has good physicochemical properties, and can maintain its original elasticity and softness during contact with body fluids and tissues without being degraded, making it a fairly stable inert substance.

[0065] like Figure 11-12 As shown, the present invention also provides an irrigation catheter system 100, including an irrigation catheter 10, a bronchoscope 101, a collector 102, a negative pressure device 103, and a liquid infusion device (not shown). The bronchoscope 101 includes a channel through which the irrigation catheter 10 passes, extending into the bronchus of the lung to form a delivery channel. The catheter body 121 of the irrigation catheter 10 can extend into the bronchoscope 101 from the inlet 1011 of the delivery channel and extend along the channel from the outlet 1012 of the delivery channel, further into a secondary bronchus. The negative pressure device 103 is connected to the negative pressure port 1121 of the irrigation catheter 10 via the collector 102 to collect the aspirated liquid. One end of the collector 102 is connected to the negative pressure port 1121 via a hose 105, and the other end is also connected to the negative pressure device 103 via a hose 105. The liquid infusion device includes a switching valve 1041, which is used to connect to the injection port 1111 in the first state and infuse physiological saline into the irrigation catheter 10.

[0066] Example 2

[0067] Example 2 proposes an irrigation catheter and irrigation system, such as Figure 13-17 As shown, the irrigation catheter provided in Embodiment 2 also includes a handle assembly 21 and a catheter assembly. The handle assembly 21 has the same or interchangeable features as the handle assembly in Embodiment 1, which will not be described in detail here. The main difference is that the catheter assembly includes a catheter body 221 and an ejection unit. The ejection unit includes a connecting wire 223, an opening 224, an ejection part 225, a limiting part 226, and an elastic connecting part 227. The catheter body 221 includes a hollow tube connecting the proximal and distal ends, and the proximal end of the catheter body 221 is connected to the communication port at the distal end of the handle assembly 21 by means of adhesive bonding or threaded connection, so that the hollow tube of the catheter body is connected to the communication port.

[0068] The proximal end of the connecting wire 223 is connected to the mandrel, and the distal end of the connecting wire 223 passes through the limiting part 226 and the elastic connecting part 227 and is connected to the ejector part 225. The distal end of the connecting wire 223 includes a connecting segment 2231 for fixing. The distal end of the connecting segment 2231 is wound and fixed to the proximal end of the connecting ejector part 225 to increase the fixing reliability of the distal end of the connecting wire 223. Figure 14 and Figure 16 As shown.

[0069] In this embodiment, the opening 224 is the distal port of the catheter body 221. The opening 224 remains connected to the inside and outside of the catheter body in both the first and second states. The limiting part 226 can be glued to the distal end of the catheter body 221. The proximal end of the ejector part 225 is connected to the distal side of the limiting part 226 via an elastic connecting part 227. Simultaneously, the proximal end of the ejector part 225 is connected to the mandrel via a connecting wire 223.

[0070] The pop-out portion 225 is located on the distal side near the limiting portion 226. In the first state, the pop-out portion 225 can retract into the distal end of the conduit body 221, such as... Figure 13-14 As shown, the distal end of the pop-out portion 225 is flush with the distal end of the catheter body 221. In other embodiments, the pop-out portion is located inside the catheter body, and the distal end of the pop-out portion can also be close to the distal port of the catheter body. When switching from the first state to the second state, the pop-out portion 225 can be ejected axially from the distal port of the catheter body 221 to support the bronchial wall. Thus, under negative pressure suction, the bronchial wall can be prevented from adhering to the distal end of the catheter body due to negative pressure suction, thereby blocking the distal port.

[0071] In this embodiment, such as Figure 14-17 As shown, the pop-out part 225 includes a deformable part 2251 located in the middle and anchors 2252 that close the two ends of the deformable part 2251. The anchor 2252a on the proximal side is an anchoring plate with multiple through holes so that the connecting section 2231 at the distal end of the connecting wire 223 can be wound and fixed through the through holes. The size of the anchoring plate is smaller than the diameter of the conduit body so that the pop-out part 225 can move along the axial direction of the conduit body 221. The anchor 2252b on the distal side of the pop-out part 225 is an annular anchoring plate. The annular part is used to fix the distal end of the deformable part.

[0072] like Figure 16-17 As shown, the deformable part 2251 is a mesh structure formed by fixing the two ends of the braided wire to the anchor plates at corresponding positions. The central area of ​​the limiting part 226 has a perforation 2261 to allow the connecting wire 223 to pass through while ensuring that the liquid can flow along the perforation 2261. The elastic connecting part 227 is a spiral spring body, that is, the elastic connecting part 227 is a hollow structure to ensure axial communication, so that the entire pop-out part 225 will not affect the flow of liquid in the first and second states. In other embodiments, the pop-out part can also be an integral structure, as long as it is ensured that in the second state, the pop-out part is freed from the restraint of the connecting wire and is thus ejected to the distal end by the elastic connecting part. At this time, the pop-out part can support the bronchus wall to prevent the bronchus wall from blocking the distal end of the duct body.

[0073] After natural expansion, the deformable part 2251 takes on a spherical or ellipsoidal shape. At this point, the maximum radial dimension of the deformable part 2251 is greater than the outer diameter of the duct body 221, which allows the ejector part 225 to better expand the bronchial wall. Figure 16-17 As shown.

[0074] The connecting wire 223 can compress the elastic connecting portion 227 axially towards the proximal end by pulling the pop-out portion 225. The connecting wire 223 is tensioned to maintain the compressed state of the elastic connecting portion 227, thereby achieving the first state, such as... Figure 13-14 As shown, when the mandrel is in the first state relative to the housing, the pop-out part 225 is completely contained within the distal end of the conduit body 221, and the limiting part 226, the elastic connecting part 227, and the pop-out part 225 are all axially connected; when the radial dimension of the deformable part 2251 in its natural expansion state is greater than the inner diameter of the conduit body 221, the deformable part 2251 is in a radially compressed state in the first state.

[0075] By pressing the compression spring to the compressed state, the spindle can be moved to a second state relative to the housing, at which point... Figure 15-17 As shown, during the process of the mandrel moving from the first state to the second state relative to the housing, the connecting wire 223 loosens, and the pop-out part 225 loses the constraint of the tension of the connecting wire 223, causing the pop-out part 225 to pop out axially to the distal end under the elastic action of the elastic connecting part 227. The pop-out part 225 pops out from the distal port of the catheter body 221, so that even under negative pressure, the pop-out part 225 can support the bronchial wall to maintain a certain gap space between the bronchial wall and the distal port 224 of the catheter body 121. This prevents the bronchial wall from sticking tightly to the distal port of the catheter body under negative pressure aspiration, thus blocking the opening and making it impossible to aspirate the physiological saline after irrigation, thereby failing to achieve the purpose of diagnosis or drug administration. At the same time, it prevents complications such as hypoxemia or fever caused by the retention of irrigation fluid in the bronchus.

[0076] In this embodiment, the deformable portion 2251 is in a radially compressed state in the first state, and in a naturally expanded state in the second state, and its radial dimension in the naturally expanded state is larger than the outer diameter of the conduit body 121, such as... Figure 14 and Figure 16-17 As shown, the deformable part 2251 is made of a material with shape memory, such as a superelastic nickel-titanium alloy or stainless steel.

[0077] It is understood that each outer conical surface of the mandrel in this embodiment also includes a groove for accommodating the sealing ring. By abutting against each inner conical surface of the first housing and the second housing and cooperating to squeeze the sealing ring, the sealing performance is increased, ensuring the negative pressure environment when the second channel is connected, and preventing suction difficulties caused by poor sealing performance.

[0078] Similarly, the irrigation catheter of this embodiment can also be combined with a bronchoscope, a collector, a negative pressure device and a liquid infusion device to form an irrigation catheter system for bronchoalveolar lavage, which will not be described in detail here.

[0079] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0080] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An irrigation catheter, characterized in that, The device includes a handle assembly and a catheter assembly. The handle assembly includes a housing and a movable component, which is movably located within the housing, allowing the movable component to be in a first state and a second state relative to the housing. The catheter assembly includes a catheter body and a ejection unit. The distal end of the catheter body has an opening communicating with the outside. The catheter body includes a hollow tube connecting its proximal and distal ports. The ejection unit includes a connecting wire and an ejection part. The proximal end of the connecting wire is connected to the movable component, and the distal end of the connecting wire is connected to the ejection part. When the movable component is in the first state, the connecting wire is tensioned, and the ejection part is retracted into the catheter body. When the movable component is in the second state, the connecting wire is relaxed, and the ejection part ejects from the opening and is located outside the catheter body, creating a certain spatial gap between the bronchial wall and the opening. In both the first and second states, the opening communicates with the outside and the hollow tube of the catheter body.

2. The irrigation catheter according to claim 1, characterized in that, The irrigation catheter also includes a catheter head fixed to the distal end of the catheter body. The pop-out portion includes a connecting section and a pop-out section. The distal end of the connecting wire is connected to the proximal end of the pop-out section. One end of the connecting section is fixed to the proximal end of the catheter head, and the other end of the connecting section is connected to the distal end of the pop-out section. The position of the pop-out section corresponds radially to the position of the opening.

3. The irrigation catheter according to claim 2, characterized in that, The catheter assembly also includes a fastener body, wherein the connecting segment is wound around the fastener and together secured within the catheter head.

4. The irrigation catheter according to claim 2, characterized in that, The pop-out section includes a convex elastic wire.

5. The irrigation catheter according to claim 2, characterized in that, The opening includes a first opening and a second opening, and a blocking portion is included between the first opening and the second opening, the blocking portion blocking part of the pop-out segment outside the conduit body.

6. The irrigation catheter according to claim 5, characterized in that, A receiving groove is provided on the outer side of the blocking part.

7. The irrigation catheter according to claim 1, characterized in that, The ejection unit further includes an elastic connecting part and a limiting part fixed to the distal end of the catheter body. The limiting part is located on the proximal side of the ejection part. The ejection part and the limiting part are connected by the elastic connecting part. The distal end of the connecting wire passes through the limiting part and the elastic connecting part, and the distal end of the connecting wire is connected to the proximal end of the ejection part. The opening is the distal port of the catheter body. In the first state, the distal end of the ejection part is close to or flush with the distal port of the catheter body.

8. The irrigation catheter according to claim 7, characterized in that, The pop-out section includes a deformable section and anchors. The deformable section is woven from a material with shape memory. Two anchors are located at both ends of the deformable section to close it off.

9. The irrigation catheter according to claim 8, characterized in that, The anchor includes an anchor plate, the anchor plate on the proximal side having multiple through holes, and the anchor plate on the distal side being annular.

10. The irrigation catheter according to claim 9, characterized in that, The maximum width of the anchor plate is less than the inner diameter of the conduit body, and the maximum radial dimension of the deformable part under natural expansion is greater than the outer diameter of the conduit body.

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