Visual interventional medical catheter and method of assembly

Abstract

The application relates to the field of medical devices, in particular to a visual interventional medical catheter and an assembling method, which comprises the following steps: a catheter main body is internally provided with a main operation cavity, an infusion cavity and an imaging channel which extend along the axial direction, the distal end of the imaging channel is provided with an imaging assembly, a cable which is matched with the imaging assembly is arranged in the imaging channel; a connecting seat is connected to the proximal end of the catheter main body; an extension pipe is arranged at the distal end of the catheter main body, coaxially communicates with the main operation cavity, and the distal end of the extension pipe protrudes from the distal end face of the catheter main body. The application can solve the technical problems of insufficient positioning accuracy, complicated operation, radiation exposure and low operation efficiency caused by the dependence on indirect image guidance in the existing puncture operation, and simultaneously provides an assembling method, which can realize quick catheter assembling, ensure the assembling strength and sealing performance.

Description

Technical Field

[0001] This invention relates to a medical device, specifically to a visual interventional medical catheter and its assembly method. Background Technology

[0002] Cardiac catheterization is an important modern treatment for heart diseases such as arrhythmias and coronary artery disease. Among various procedures (including atrial fibrillation ablation, left atrial appendage occlusion, and valve implantation), precise identification of catheter location and establishment of access are required. For example, the interventional device is inserted into the left atrium through the interatrial septum, and puncturing the foramen ovale is a key step in establishing left atrial access.

[0003] Accurately identifying the location of the foramen ovale and precisely locating the puncture point during foramen ovale puncture is the core challenge of the procedure. The foramen ovale is located in the anteroinferior part of the atrial septum, and its anatomical morphology varies significantly among individuals, often influenced by structures such as adipose tissue and Euclidean ridges of the atrial septum, making intraoperative localization quite challenging. Currently, clinical practice mainly relies on X-ray fluoroscopy combined with contrast agent injection, or indirect localization using imaging techniques such as transesophageal echocardiography and intracardiac echocardiography. These methods have the following drawbacks: X-ray fluoroscopy cannot directly and clearly display the soft tissue boundaries of the foramen ovale, requiring repeated injections of contrast agent for location verification, which not only increases the operation time but also introduces ionizing radiation and contrast agent-related risks; TEE requires general anesthesia or deep sedation, is complex to operate, and has poor patient tolerance; while ICE can be placed in the right atrium to provide a closer view, it requires establishing an additional puncture route and occupies the catheter port, and the acquired ultrasound images lack direct visual confirmation of the surface morphology of the foramen ovale. Summary of the Invention

[0004] The purpose of this invention is to address the shortcomings of existing technologies by providing a visual interventional medical catheter and its assembly method. This catheter has a simple and compact structure and can solve the problems of accurately identifying the catheter position and establishing the access in existing catheter-based interventional surgeries. For example, in the foramen ovale puncture, the reliance on indirect image guidance leads to insufficient positioning accuracy, complex operation, radiation exposure, and low surgical efficiency. The invention also provides an assembly method that enables rapid catheter assembly and ensures assembly strength and sealing.

[0005] The objective of this invention is achieved as follows: a visual interventional medical catheter, comprising: The catheter body has an axially extending main operating chamber, an infusion chamber, and an imaging channel inside. An imaging component is provided at the distal end of the imaging channel, and a cable adapted to the imaging component is laid inside the imaging channel. A connecting seat is attached to the proximal end of the catheter body and has channels that communicate with the proximal ends of the main operating chamber, the perfusion chamber, and the imaging channel. An extension tube is located at the distal end of the catheter body, coaxially connected to the main operating chamber, and its distal end protrudes from the distal end face of the catheter body. An inflatable sac, made of transparent material, is fitted onto the distal outer wall of the catheter body. Its proximal edge is sealed to the outer wall of the catheter body, and its distal edge is sealed to the outer wall of the extension tube, forming a filling and discharging chamber. The distal end of the extension tube is provided with a first distal opening, which is located on the distal outer side of the inflatable bladder and communicates with the main operating cavity for the passage of working instruments; the distal openings of the perfusion cavity and the imaging channel are both located inside the filling and discharging chamber.

[0006] The extension tube is a transparent tube, the distal portion of the extension tube is arc-shaped, the proximal end of the extension tube is inserted into the distal portion of the main operating cavity, and the proximal end of the extension tube forms a limiting shoulder.

[0007] The connector has a main channel, and the proximal end of the catheter body extends into the main channel and is sealed to the main channel; the proximal end face of the connector has an operating hole communicating with the main channel, and the proximal part of the main channel branches out into a first branch channel and a second branch channel; The imaging channel is connected to the first branch channel through a lateral opening on the proximal sidewall of the catheter body, and the perfusion cavity is connected to the second branch channel through an opening on the proximal sidewall of the catheter.

[0008] The imaging channel includes an independent illumination cavity and an imaging cavity, which are separated by the wall of the conduit body; a camera module is sealed at the second distal opening of the imaging cavity, and an illumination element is sealed at the third distal opening of the illumination cavity. The imaging cavity contains an image signal cable, and the illumination cavity contains an illumination power supply cable. Both extend along the axial direction of the main body of the conduit, pass through a lateral opening, the main channel, and the first branch channel into the tail cable sleeve, and exit from the proximal end of the tail cable sleeve.

[0009] The proximal end of the infusion chamber is connected to a flexible adapter hose; the distal end of the adapter hose is inserted into the infusion chamber, and its outer wall is sealed and fixed to the inner wall of the infusion chamber by an annular adhesive layer. The port of the adapter hose and the infusion chamber is sealed with an annular UV adhesive. The proximal end of the adapter hose passes through a lateral opening, a main channel, and a second branch channel in sequence. The distal part of the adapter hose and the second branch channel are sealed and connected by a filling layer formed by UV adhesive. The distal end of the water injection pipe is inserted and fixed inside the second branch channel, and its outer wall is bonded and fixed to the inner wall of the second branch channel; the proximal end of the adapter hose extends into the inner cavity of the distal end of the water injection pipe, and the adapter hose and the inner cavity of the water injection pipe are sealed and connected by a sealing adhesive layer.

[0010] The distal end of the water injection pipe is a transparent connector end, and the distal part of the adapter hose extending out of the second branch channel is sealed to the water injection pipe with UV glue.

[0011] The distal end of the catheter body is provided with a front end connecting section, which is integrally formed with the extension tube. Its proximal end is fixedly connected to the distal end of the main body of the catheter body, so that the extension tube is coaxially connected with the main operating chamber. The proximal end face of the front end connecting section and the distal end face of the main body are sealed and fixed by an adhesive layer, and the outer peripheral walls of the two are smoothly connected.

[0012] A method for assembling any of the described visual interventional medical catheters. Includes the following steps: S1. Align and attach the first end of the balloon body to the distal part of the catheter body, and seal and fix the first end of the balloon body to the distal part of the catheter body by welding. S2. The proximal end of the extension tube is fixed to the distal port of the main operating cavity by adhesive bonding, so that the extension tube is connected to the main operating cavity and the distal end extends outward; the camera module and the illumination element are respectively assembled and fixed to the distal port of the imaging channel of the catheter body, and the cables of the two are led out from the proximal opening through the imaging channel. S3. The second end of the capsule is fitted and aligned with the distal part of the extension tube. The second end of the capsule and the distal part of the extension tube are sealed and fixed by welding, so that the capsule, the main body of the catheter and the extension tube are enclosed to form a closed cavity structure. S4. Select a guide tube that combines rigid support and flexible bending performance, and run it in reverse from the far end opening of the connector to the near end. After passing through the internal interface, both ends are exposed on both sides of the connector. Lead the cables of the camera module and the lighting element out from the imaging channel and run them into the inside of the guide tube. Then, pull the guide tube and the cables inside the tube back along the interface to complete the cable routing in the connector. S5. Insert the guide wire into the adapter hose, insert the adapter hose with the guide wire attached into the proximal port of the infusion chamber, and fix it with instant adhesive; apply UV glue to the port of the infusion chamber and cure it. After curing, pull out the guide wire, insert the guide wire into the main channel from the corresponding interface of the connector in reverse and out from the far end opening, and then reinsert the far end of the guide wire into the adapter hose. S6. Insert the positioning mandrel from the tail end of the connector until the positioning mandrel passes through the main channel and exits from the far end opening of the connector. Insert the far end of the positioning mandrel into the main operating cavity of the catheter body. Apply UV adhesive to the proximal end of the catheter body and cure it. Insert the positioning mandrel, the guide wire, and the proximal part of the catheter body treated with instant adhesive into the far end opening of the connector as a whole. Then, retract the positioning mandrel along the corresponding cavity, retract the guide wire along the second branch channel, and retract the cable along the first branch channel until the catheter body reaches the preset assembly position. S7. Fill the distal mating section of the adapter hose and the second branch channel with UV glue and compact it. Irradiate the branch channel opening with ultraviolet light to cure and form a sealing layer. Insert the water injection pipe into the second branch channel to achieve a sealed connection. Seal the connection pipe joint at the near end of the water injection pipe. Lead the cable out through the first branch channel and pass it into the tail cable sleeve. Connect the electrical connector at the near end of the tail cable sleeve.

[0013] In steps S1 and S3, the welding process is laser welding, and a continuous sealed weld is formed on the mating surface after welding.

[0014] In step S7, UV glue is injected into the gap between the adapter hose and the second branch channel, and then the water injection pipe is inserted, allowing the UV glue to overflow along the inner wall between the adapter hose and the water injection pipe. Then, the distal section of the transparent water injection pipe is cured by UV irradiation, so that a sealed connection is formed between the wall of the water injection pipe and the inner wall of the second branch channel, and a sealed connection is formed between the adapter hose and the inner wall of the water injection pipe.

[0015] The above-mentioned solution offers the following advantages: In this invention, the imaging component window of the imaging channel is always immersed in a transparent liquid medium such as saline solution, rather than being directly exposed to blood. This avoids direct contamination of the optical window by blood cells and proteins, thus ensuring image clarity. The perfusion chamber can control the filling or emptying of the capsule by injecting or withdrawing liquid into the filling / draining chamber, while simultaneously replacing the liquid within the capsule to remove residual air bubbles.

[0016] Through the integrated multi-lumen catheter body, the distal transparent inflatable balloon, and the coaxial extension tube, the system can realize interventional device operation, balloon support positioning, and intraoperative direct imaging, which can effectively improve the accuracy and safety of puncture-related procedures such as cardiac intervention.

[0017] The inflatable capsule is made of transparent material and encloses a fluid-filling chamber. With the perfusion chamber connecting to the chamber, a transparent filling medium can be injected into the chamber through the perfusion chamber to expand the capsule. This expands the surrounding tissue and blood at the distal end of the catheter, creating a stable optical observation space for the imaging component without tissue adhesion or blood obstruction. This fundamentally solves the problem of blurred vision caused by tissue and blood covering the imaging component during interventional procedures. Furthermore, the inflated capsule provides flexible support and filling for the tissue surrounding the target area, reducing bleeding at the puncture site. It also helps anchor the distal end of the catheter, preventing catheter displacement during the procedure and improving operational stability. The flexible capsule has low tissue irritation and can adapt to different anatomical structures, avoiding the risk of tissue contusion and perforation caused by rigid support structures. The distal opening of the imaging channel is located inside the fluid-filling chamber. The imaging component can clearly observe the morphology of the distal target area tissue through the filling medium and the transparent capsule wall, ensuring full visibility and controllability throughout the puncture and other procedures.

[0018] The extension tube is coaxially connected to the main operating chamber and its distal end protrudes beyond the outer side of the capsule. This ensures that the puncture instrument can directly reach the target tissue outside the capsule through the main operating chamber and the extension tube, enabling precise puncture under direct vision. It also independently separates the instrument passage from the filling / discharging chamber, preventing backflow of filling media or blood into the main operating chamber and thus avoiding interference with instrument operation. Furthermore, the filling pressure of the capsule will not compress the diameter of the main operating chamber, ensuring smooth instrument passage. Additionally, the extension tube provides axial guidance and limitation for the needle exit direction, reducing needle deflection and improving puncture accuracy. Both ends of the capsule are sealed to the outer walls of the catheter body and the extension tube, respectively, forming a closed filling / discharging chamber. The sealing path is clear and reliable, stably maintaining the filling pressure and ensuring consistent capsule shape.

[0019] The proximal connector connects to the proximal end of the catheter body and correspondingly connects to each cavity, allowing the operating pathway, perfusion pathway, and imaging pathway to be orderly branched at the proximal end. This facilitates the separate connection of interventional instruments, perfusion devices, and imaging processing equipment during clinical operations. The overall structure is neat and the operation is convenient. This invention solves the technical problems of insufficient positioning accuracy, complex operation, radiation exposure, and low surgical efficiency caused by reliance on indirect image guidance in existing puncture procedures.

[0020] The present invention will be further described below with reference to the accompanying drawings and specific embodiments. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the structure of the present invention; Figure 2 This is a cross-sectional view of the catheter in this invention; Figure 3 This is a schematic diagram of the cross-sectional structure of the cyst. Figure 4 for Figure 2 Sectional view at point B; Figure 5 This is an exploded view of the assembly structure of the connector in this invention; Figure 6 for Figure 5 Enlarged view at point C; Figure 7 Schematic diagram of the catheter perfusion cavity layout; Figure 8 This is a schematic diagram of the actual assembly of the adapter hose.

[0022] In the attached diagram, 20 is the guide wire, 30 is the positioning mandrel, 50 is the pipe fitting, 60 is the electrical connector, 70 is the filler layer, 100 is the catheter, 101 is the catheter body, 102 is the front connecting section, 107 is the main trunk, 108 is the main operating chamber, 109 is the imaging chamber, 110 is the illumination chamber, 112 is the perfusion chamber, 113 is the first lateral opening, 114 is the second lateral opening, 115 is the illumination element, 201 is the capsule body, and 202 is the proximal end. Edge, 203 is the distal edge, 204 is the filling and discharging chamber, 300 is the extension tube, 302 is the first distal opening, 400 is the connecting seat, 406 is the main channel, 407 is the operating hole, 409 is the first branch channel, 410 is the second branch channel, 500 is the adapter hose, 600 is the water injection pipe, 601 is the transparent connector end, 701 is the image signal cable, 702 is the lighting power supply cable, 800 is the tail cable sleeve, and 1092 is the camera module. Detailed Implementation

[0023] The specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. It should be noted that the described embodiments are merely some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0024] In the description of this invention, the term proximal refers to the end closer to the operator, and distal refers to the end farther from the operator and entering the body. The term axial refers to the direction along the length of the catheter body, and radial refers to the direction perpendicular to the axial direction. The term multiple refers to two or more. Unless otherwise explicitly specified and limited, the terms installation, connection, linkage, and fixation should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections, electrical connections, or signal connections; they can refer to direct connections or indirect connections through an intermediate medium. For those skilled in the art, the specific meaning of the above terms in this invention can be understood according to the specific circumstances.

[0025] In the description of this specification, references to the terms "an embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0026] See Figures 1 to 8 This invention provides an embodiment of a visualized intracardiac catheter. The catheter 100 includes a catheter body 101, a connector 400, an extension tube 300, and an inflatable balloon 201. The catheter body 101 has a long, flexible tube structure, the length of which is set according to clinical application needs, preferably to reach the foramen ovale of the right atrium via the femoral vein.

[0027] The catheter body 101 has a proximal and distal end, and its cross-sectional outer contour can be circular. The catheter body 101 is made of medical-grade polymer material, which has good flexibility and biocompatibility. Multiple independent lumens are axially arranged inside the catheter body 101, including a main operating lumen 108, an infusion lumen 112, and an imaging channel. The cross-sectional shape of each lumen can be circular, D-shaped, or irregular, allowing for the most compact arrangement within a limited circular cross-section.

[0028] An imaging component is provided at the distal end of the imaging channel, and a cable adapted to the imaging component is laid in the imaging channel; the imaging component may include a camera module 1092, and the imaging channel includes at least one cavity for accommodating an illumination element, the camera module 1092 and its cable.

[0029] As an alternative implementation, the imaging channel is an independent cavity that simultaneously houses the illumination element, the camera module 1092, and its cables.

[0030] As an alternative implementation, the imaging channel can also employ two independent cavities to achieve illumination and imaging functions respectively. Both methods can achieve visualization of the distal end of the catheter 100, and those skilled in the art can choose according to actual needs.

[0031] The inner diameter of the main operating chamber 108 is adapted to the outer diameter of a conventional puncture needle or guidewire. As a channel that runs through the entire length of the catheter body 101, its proximal end is connected to the connector 400 and its distal end is connected to the extension tube 300, providing a continuous passage for the puncture instrument from outside the body to inside the body.

[0032] The distal end of the perfusion chamber 112 is connected to the filling and draining chamber 204 of the inflatable bladder 201, and is used to inject or withdraw physiological saline into the filling and draining chamber 204, thereby realizing the filling or emptying of the bladder 201.

[0033] A connector 400 is fixedly connected to the proximal end of the catheter body 101. The connector 400 can be injection molded from medical-grade polymer material and has a bifurcated structure.

[0034] The catheter body 101 is connected to the connector 400 and can be fixed and sealed by adhesive or heat shrink tubing. The connector 400 is provided with multiple independent channels, the number and type of which correspond to the various cavities inside the catheter body 101.

[0035] Of course, the lighting element, camera module 1092, and cables can share a cavity on the connector 400, which reduces the number of cavities and structural complexity without affecting the functionality of the lighting element and camera module 1092. The image signal cable 701 is a miniature coaxial cable or flexible circuit board used to transmit video signals acquired by the remote camera to the near-end image processing equipment. The lighting cavity 110 contains a lighting power supply cable 702. The lighting power supply cable 702 is an insulated cable used to supply power to the remote lighting element.

[0036] See Figure 3 An extension tube 300 is disposed at the distal end of the catheter body 101. The inner lumen of the extension tube 300 is coaxially connected to the main operating chamber 108, and the distal end of the extension tube 300 protrudes axially from the distal end face of the catheter body 101. The outer diameter of the extension tube 300 is smaller than the outer diameter of the catheter body 101 to reduce obstruction of the field of view of the camera module 1092.

[0037] The distal end of the extension tube 300 is provided with a first distal opening 302. The first distal opening 302 is located on the distal outer side of the inflatable sac 201, that is, on the distal side of the distal edge 203 of the sac 201. The first distal opening 302 communicates with the main operating cavity 108 and is used for the passage of puncture instruments.

[0038] The puncture instrument passes sequentially through the connecting seat 400, the main operating chamber 108, and the inner cavity of the extension tube 300, and then extends out from the first distal opening 302. Since the first distal opening 302 is located on the distal outer side of the capsule 201, the capsule 201 will not obstruct the extension path of the puncture instrument after it is filled.

[0039] An inflatable capsule 201 is fitted onto the distal outer wall of the catheter body 101. The inflatable capsule 201 is a thin-film structure made of medical-grade elastic polymer material, such as TPU or liquid silicone rubber.

[0040] In its natural state, the inflatable capsule 201 is in a contracted state. For capsules 201 made of compliant materials such as silicone or rubber, their natural state is a wrinkled state with irregular folds on the surface; for capsules 201 made of non-compliant materials such as PET or nylon, their natural state is a folded state, contracted in a petal-like manner.

[0041] Understandably, regardless of the material used, the inflatable sac 201 fits tightly against the outer wall of the catheter body 101 in its uninflated state, in order to reduce the outer dimensions of the catheter 100 during its advancement and facilitate delivery within the blood vessel.

[0042] The proximal edge 202 of the inflatable balloon 201 is sealed to the outer wall of the catheter body 101. The distal edge 203 of the inflatable balloon 201 is sealed to the outer wall of the extension tube 300.

[0043] The aforementioned sealing connection can be achieved through heat fusion, medical adhesive bonding, laser welding, or other methods. The proximal edge 202 and the distal edge 203 respectively enclose the outer wall to form a sealed filling / discharging chamber 204. This filling / discharging chamber 204 is located within the annular space between the capsule 201 and the outer wall of the catheter body 101.

[0044] The distal opening of the perfusion chamber 112 and the distal opening of the imaging channel are both located inside the filling and discharging chamber 204. That is, when the inflatable bladder 201 is filled, the distal opening of the perfusion chamber 112 and the distal opening of the imaging channel are both enclosed in the liquid environment inside the bladder 201.

[0045] Understandably, the distal optical window of the imaging channel is always immersed in a transparent liquid medium such as saline solution, rather than being directly exposed to blood. This avoids direct contamination of the optical window by blood cells and proteins, thus ensuring image clarity. The perfusion chamber 112 can control the filling or emptying of the capsule 201 by injecting or withdrawing liquid into the filling / draining chamber 204, while simultaneously replacing the liquid within the capsule 201 to remove any remaining air bubbles.

[0046] In some embodiments, the extension tube 300 is a transparent tube, the distal portion of the extension tube 300 is arc-shaped, the proximal end of the extension tube 300 is inserted into the distal portion of the main operating cavity 108, and the proximal end of the extension tube 300 forms a limiting shoulder.

[0047] It is understood that the extension tube 300 is made of transparent tube, so that the imaging component located in the filling and discharging chamber 204 can observe the advancement status of the puncture instrument in the extension tube 300 and the tissue condition at the distal end of the extension tube 300 in real time through the wall of the extension tube 300. This allows for full visualization of the puncture operation without the need for additional imaging channels, reducing the risk of blind puncture and improving the accuracy and safety of interventional procedures.

[0048] The distal portion of the extension tube 300 is arc-shaped, which can conform to the anatomical curvature of the human body cavity, thereby reducing the stimulation and damage of the distal end of the catheter 100 to the inner wall of the cavity; at the same time, the arc-shaped segment can guide the needle exit angle of the puncture instrument, making it easier to align with the target position, so as to meet the intervention needs under complex anatomical structures.

[0049] For example, when applied to Marshall vein ablation, the arc-shaped distal end can conform to the natural anatomical curvature of the coronary sinus, smoothly enter the target vein opening, and avoid surrounding large blood vessels. Ablation alcohol can be quickly injected through the main operating chamber 108. With the clear field of view formed by the filling and discharging chamber 204, the imaging component can clearly identify the vein entrance boundary and the morphology of the surrounding tissue, avoiding tissue damage caused by the tip of the catheter 100 contacting the tissue, while accurately anchoring the ablation target area.

[0050] For example, in the fossa ovalis puncture procedure, the arc-shaped extension tube 300 can naturally form an insertion angle that matches the plane of the atrial septum. With the help of the front-end visual field, the thin target area of ​​the fossa ovalis can be quickly identified, and the puncture instrument can be guided to puncture accurately along the preset angle, effectively reducing the risk of puncture deviation and accidental puncture of surrounding important tissues, thereby significantly improving the success rate and safety of complex intracardiac interventional procedures.

[0051] The limiting shoulder can be adapted to the shoulder on the puncture needle to limit the maximum length of the puncture needle extension and avoid damage to the tissue.

[0052] The connecting seat 400 has a main channel 406, and the proximal end of the catheter body 101 extends into the main channel 406; the proximal end face of the connecting seat 400 has an operating hole 407 communicating with the main channel 406. The main channel 406 branches into a first branch channel 409 and a second branch channel 410 on its proximal side. The imaging channel is connected to the first branch channel 409 through a lateral opening on the proximal sidewall of the catheter body 101. The perfusion cavity 112 is connected to the second branch channel 410 through an opening on the proximal sidewall of the catheter 100. The openings corresponding to the perfusion cavity 112 and the imaging channel can be the same opening, or they can be independently corresponding to different openings that are staggered in the axial or circumferential direction. When different openings are set, each opening at the proximal end of the catheter 100 is smaller, and the strength of the proximal end of the catheter 100 is weakened less.

[0053] When a single opening is shared, it facilitates the processing of lateral openings. In some embodiments, the proximal sidewall of the catheter body 101 is provided with a first lateral opening 113 and a second lateral opening 114 spaced apart along the axial direction. The first lateral opening 113 penetrates the sidewall and connects to the imaging channel, corresponding to and communicating with the inlet end of the first branch channel 409. The second lateral opening 114 penetrates the sidewall and connects to the perfusion chamber 112, corresponding to and communicating with the inlet end of the second branch channel 410.

[0054] Understandably, the multi-channel bifurcation layout and sidewall docking structure of the aforementioned connector 400 enable integrated placement and reliable sealing of the proximal end of the multi-lumen catheter 100. Coaxial insertion and fixation of the proximal end of the catheter body 101 via the main channel 406 provides stable proximal support for the catheter body 101, ensuring the axial alignment accuracy of each lumen. Simultaneously, the operating hole 407 on the proximal end face is coaxially connected to the main channel 406, fully preserving the axial diameter of the main operating chamber 108, ensuring smooth insertion of interventional instruments such as puncture devices without interference from the proximal branching structure.

[0055] The main channel 406 branches proximally to form two independent branch channels 409 and 410. Together with two sets of lateral openings on the sidewall of the catheter body 101, the imaging channel and the proximal access of the perfusion chamber 112 can be led out from the sidewall of the catheter body 101 and connected accordingly. This eliminates the need to split multiple independent outlets on the proximal end face of the catheter body 101, which simplifies the end processing of the catheter body 101, ensures the integrity of the main operating chamber 108, and allows the electrical transmission path and the liquid perfusion path to be orderly branched at the proximal end. The two are independent of each other and do not interfere with each other, reducing the risk of interference and wear of the lines and tubing. It also facilitates the proximal connection of the electrical connector and the perfusion connector, improving the convenience of clinical operation.

[0056] The cable and fluid inside the side-wall opening can be smoothly led out laterally without large-angle bends, which reduces the bending loss of the signal line and the flow resistance of the injection fluid.

[0057] In some embodiments, the imaging channel includes an independent illumination cavity 110 and an imaging cavity 109, which are separated by the wall of the conduit body 101; a camera module 1092 is sealed at the second distal opening of the imaging cavity 109, and an illumination element 115 is sealed at the third distal opening of the illumination cavity 110.

[0058] The camera module 1092 may include a miniature image sensor chip, a lens assembly, and related signal processing circuitry. The overall outer diameter of the camera module 1092 is adapted to the inner diameter of the imaging cavity 109. The lens of the miniature camera assembly faces the second distal opening, i.e., towards the distal end of the catheter body 101, to acquire real-time images of the tissue in front of the catheter 100.

[0059] The lighting element can be made of optical fiber to transmit the illumination light generated by an external light source to the far end of the conduit 100, or it can be made of a miniature LED light-emitting chip. The lighting element provides sufficient illumination for the miniature camera assembly.

[0060] The imaging cavity 109 contains an image signal cable 701, and the illumination cavity 110 contains an illumination power supply cable 702. Both extend axially along the main body 101 of the conduit, pass through a lateral opening, the main channel 406, and the first branch channel 409 into the tail cable sleeve 800, and exit from the proximal end of the tail cable sleeve 800. When the two lateral openings are independently configured, the image signal cable 701 and the illumination power supply cable 702 can both pass through the first lateral opening 113.

[0061] Understandably, the imaging channel employs independent illumination chambers 110 and imaging chambers 109, separated by the wall of the catheter body 101. Illumination elements and camera modules 1092 are respectively sealed at their distal openings. On one hand, this independent chamber layout completely isolates the illumination and imaging light paths, preventing direct light from entering the imaging chamber 109 and causing stray light, glare, and overexposure, effectively improving the contrast and clarity of the image and ensuring the accuracy of intraoperative observation. Simultaneously, each cavity has its own independent transmission line, preventing interference and wear, reducing the risk of signal interference, and ensuring stable imaging signal transmission. It also avoids the two types of cables from tangling, being squeezed, or wearing down, improving the electrical reliability of the lines and extending their service life. It also facilitates independent assembly and debugging.

[0062] On the other hand, the camera module 1092 and the illumination element are respectively sealed and fixed at the far end opening of the corresponding cavity, which can not only place the imaging acquisition end and the illumination emission end at the farthest end of the conduit 100, obtain an unobstructed forward field of view and sufficient near-field illumination effect, and ensure a clear and bright imaging field of view; but also block body fluids and perfusion fluids from entering the cavity through the port sealing structure, protect the transmission lines and devices inside the cavity from contamination and corrosion, improve the working stability and electrical safety of the devices, and meet the sealing and protection requirements of in vivo interventional operations.

[0063] In addition, the chamber layout of the illumination chamber 110 and the imaging chamber 109, together with the overall arrangement of the main operating chamber 108 and the infusion chamber 112, makes the cross-sectional structure of the catheter body 101 more symmetrical and balanced. This is conducive to the stable implementation of the extrusion molding process, improves the dimensional accuracy and production yield of the tube, and ensures that the wall thickness of the tube is uniform throughout after molding, avoiding stress weak areas caused by uneven wall thickness, and improving the overall mechanical stability of the tube.

[0064] The cable is led out from the side wall of the catheter 100 through the first lateral opening 113, smoothly transitions through the main channel 406 and merges into the first branch channel 409. There is no need to set a separate outlet on the proximal end face of the catheter body 101, ensuring the integrity and coaxial unobstructed structure of the end face of the main operating chamber 108, and not interfering with the insertion of interventional instruments. Moreover, the cable path is gently curved, which can reduce signal attenuation and structural damage caused by cable bending.

[0065] Both types of cables are uniformly connected into the 800mm tail cable sleeve before being led out, which can provide centralized protection for the internal cables, reduce damage to the lines caused by external pulling and bending, and at the same time make the near-end cables neat and orderly, which facilitates the unified connection of electrical connectors and improves the convenience of assembly and clinical operation.

[0066] In some implementations, the proximal end of the infusion chamber 112 is connected to a flexible adapter hose 500. The adapter hose 500 is made of a flexible and bendable material, which can smoothly adapt to the bending and outgoing path from the infusion chamber 112 through the second lateral opening 114, the main channel 406 to the second branch channel 410, avoiding problems such as narrowing of the flow channel and stress concentration cracking at the bend of the rigid pipeline, and ensuring continuous and stable flow of the infusion fluid.

[0067] The distal end of the adapter hose 500 is inserted into the infusion chamber 112, and its outer wall is sealed and fixed to the inner wall of the infusion chamber 112 by an annular adhesive layer. The port of the adapter hose 500 and the infusion chamber 112 are sealed with an annular UV adhesive. The proximal end of the adapter hose 500 passes through the second lateral opening 114, the main channel 406, and the second branch channel 410 in sequence. The distal part of the adapter hose 500 and the second branch channel 410 are sealed and connected by a filling layer 70 formed by filled UV adhesive. Injection via UV and then sealing can achieve a higher sealing effect. Instant adhesives have a high curing shrinkage rate, are brittle and hard, and are prone to internal stress microcracks. They are prone to leakage after long-term water immersion. Even slightly large gaps will result in incomplete curing, weak sealing reliability, and easy breakage and shedding of hard debris after curing due to vibration. Excess adhesive will also leave white residue that is difficult to clean, and the cleanliness is uncontrollable. After applying more adhesive, it cures in a few seconds, there is no assembly adjustment window, and the yield rate is low. UV adhesives generally have a curing shrinkage rate of less than 2%, a dense adhesive layer without internal cracks, strong water vapor barrier properties, and can fill small gaps, exhibiting excellent long-term watertight stability. Before curing, there are no volatile components or white mist precipitation. After curing, the adhesive layer is tough, vibration-resistant, and impact-resistant, and will not break or shed. Uncured excess adhesive can be wiped away directly without white residue, and cleanliness is completely controllable. Furthermore, it can remain liquid for a long time in a light-protected environment, allowing for full mixing and alignment before UV irradiation for second-level curing, ensuring better assembly precision and sealing consistency.

[0068] The distal end of the water injection pipe 600 is inserted and fixed inside the second branch channel 410, and its outer wall is bonded and fixed to the inner wall of the second branch channel 410; the proximal end of the adapter hose 500 extends into the inner cavity of the distal end of the water injection pipe 600, and the adapter hose 500 and the inner cavity of the distal end of the water injection pipe 600 are sealed and connected by a sealing adhesive layer.

[0069] It should be noted that the perfusion chamber 112 is internally connected to the perfusion passage via a flexible adapter hose 500 at its proximal end. It is connected to the water injection pipe 600 with a multi-stage seal. The distal end of the adapter hose 500 adopts a double-sealing structure combining annular adhesive and port annular UV adhesive. The axial adhesive layer provides reliable connection strength and the first sealing barrier, while the port UV adhesive forms a supplementary end face seal. The two seals are redundant, significantly improving the pressure resistance of the perfusion passage. It can withstand pressure fluctuations during the perfusion process and effectively prevents the perfusion fluid from leaking into other cavities of the catheter 100, especially isolating it from the main operating chamber 108 and protecting the electrical components inside the chamber from liquid contamination.

[0070] The irrigation pathway is internally connected through the lateral opening on the side wall of catheter 100 and the internal channel of connector 400. There is no need to open an irrigation outlet separately on the proximal end face of catheter body 101. This ensures the integrity of the end face structure and coaxial unobstructedness of the main operating chamber 108, and also ensures that there is no exposed connecting pipeline at the proximal end of catheter 100. The overall structure is neat and avoids pipeline entanglement and interference during the operation.

[0071] The water injection pipe 600 is inserted and fixed inside the second branch channel 410. The proximal end of the adapter hose 500 extends into the inner cavity of the distal end of the water injection pipe 600 to form a sleeve fit. The outer wall of the water injection pipe 600 is bonded to the inner wall of the branch channel, and the adapter hose 500 and the inner cavity of the water injection pipe 600 are fixed by filling with sealant. The multi-fit structure has both excellent connection strength and sealing performance, and strong resistance to pull-out.

[0072] It should be noted that, due to the small size of the catheter 100 and the need for a cable to extend from the proximal end of the catheter body 101, directly inserting the proximal end of the catheter 100 with adhesive could easily lead to sealing leaks. After applying instant adhesive to the proximal end of the catheter 100, the adhesive's high fluidity during insertion can cause it to drip and not adhere evenly to the catheter body 101. Furthermore, due to the deep insertion position, maintaining high coaxial precision is impossible, potentially leading to rubbing or misalignment with the main channel 406, affecting the uniform formation of the adhesive layer. Additionally, the deep insertion position makes it difficult to precisely align the infusion port with the branch channel, ensuring a good adhesive layer at the transition point. A reliable seal is difficult to achieve, but due to its deep location, visual inspection is not possible. Furthermore, during the insertion and connection of the catheter body 101, the cable needs to be threaded through simultaneously. The cable branches out laterally inside the lumen and accumulates and pushes when inserted into the main channel 406. At the same time, since the cable's impact on the catheter body 101 is random and cannot be visually observed, it seriously affects the insertion speed and accuracy of the catheter 100. How to accurately ensure the formation of an effective sealing layer at the branch channel inlet has a significant impact on the perfusion chamber 112. At best, the capsule 201 cannot be filled; at worst, the perfusion fluid flows between the various cavities and enters the main operating chamber 108, thereby entering the human bloodstream and causing serious medical accidents.

[0073] For the reasons mentioned above, in this embodiment, by introducing the adapter hose 500, the infusion cavity 112 end can be connected to the adapter hose 500 separately outside the connector 400. The adapter hose 500 can be connected first with instant adhesive to improve strength. Since the existing catheter body 101 needs to be visualized in the human body, it needs to be mixed with components such as barium sulfate during preparation. Therefore, the catheter 100 is opaque. Using instant adhesive to bond the inner cavity of the catheter 100 can provide a larger bonding area, ensuring greater bonding strength and sealing reliability. At the same time, since it is bonded outside the connector 400, the adapter hose... The bonding position between the adapter hose 500 and the infusion chamber 112 is exposed to the field of view, facilitating manual bonding operations, timely adjustments, and visual inspection of the bonding effect. After the instant adhesive is applied, UV adhesive is applied to the rim and UV cured simultaneously. Because it is located at the rim and has a visible field of view, UV curing is possible. The UV adhesive has higher viscosity, and the curing time can be adjusted according to the UV curing parameters. Before curing, the joint position can be adjusted to ensure a better bonding effect. Similarly, after UV curing, the bonding effect can be visually inspected to ensure a firm bond. It is important to emphasize that in this embodiment, both ends of the adapter hose 500 are plugged in, forming a sleeve structure with a deeper joint length, i.e., a larger joint area. Compared to the flat connection between the first branch channel 409 and the side opening of the catheter body 101, this provides better bonding and sealing effects.

[0074] With the adapter hose 500, during catheter 100 insertion, it is not necessary to have a good sealing structure for the transition area between the catheter body 101 and the branch channel opening. This facilitates the assembly of the catheter body 101. During assembly, the adapter hose 500 is led out from the corresponding branch channel. After the catheter body 101 is assembled, adhesive is injected through the opening of the corresponding branch channel outside the connector 400 to achieve a seal. This bonding also facilitates visual operation and provides a good working field of view. Therefore, in this embodiment, the infusion chamber 112 can achieve a higher level of watertight isolation from other cavities of the connector 400, especially the main operating chamber 108, through the adapter hose 500.

[0075] In some embodiments, the distal end of the water injection pipe 600 is a transparent connector end 601. The distal portion of the adapter hose 500 extending from the second branch channel 410 is sealed to the water injection pipe 600 with UV adhesive. It is understood that with this structure, the adapter hose 500 completely extends out of the connector 400, providing a better visual operating view. Simultaneously, because the adapter hose 500 corresponds to the transparent connector end 601, it can be irradiated and UV cured. Furthermore, the transparent connector end allows for visual inspection of the adhesive layer after bonding, observing for issues such as incomplete adhesion or air bubbles. This design enables the distal end of the adapter hose 500 to have a superior sealing structure, preventing liquid leakage from the injection chamber 112 from the connector of the adapter hose 500.

[0076] In some embodiments, the distal end of the catheter body 101 is provided with a front-end connecting section 102. The front-end connecting section 102 and the extension tube 300 are integrally formed. The front-end connecting section 102 and the extension tube 300 are formed into an integral component by injection molding or extrusion molding using the same mold. The proximal end of the front-end connecting section 102 is fixedly connected to the distal end of the main body 107 of the catheter body 101, so that the extension tube 300 is coaxially connected to the main operating chamber 108.

[0077] Understandably, in the field of interventional catheters 100, if the extension tube 300 is considered as an independent component, it is often considered to be connected to the catheter body 101 by adhesive bonding. Due to the need for intraoperative angiography, the tip of the catheter 100 must use a radiopaque material. This type of material is opaque and can only be fixed with instant adhesive, not with UV adhesive or other light-curing methods. The extension tube 300 itself has an extremely small diameter, suitable for guidewires or puncture needles with an outer diameter of 0.5–1.2 mm. The small size of the workpiece makes the docking operation difficult; moreover, only a very small amount of instant adhesive can be applied each time, making it very easy for the adhesive to cure prematurely before docking is completed. At the same time, the opaque nature of the material makes it impossible to visually inspect the bonding strength, often resulting in leakage during seal testing, a high rework rate, and even the extension tube 300 detaching.

[0078] Specifically, the capsule 201 needs to contact human tissue during operation, and its distal end is connected to the distal end of the extension tube 300. This forces the extension tube 300 to withstand lateral and axial loads. When not in contact with tissue, it also needs to withstand the outward tensile load generated by the expansion of the capsule 201 in its filled state. If the extension tube 300 is a split structure, the connection strength is provided only by a very small adhesive layer inside the lumen. The adhesive area is limited, making it difficult to withstand large loads in all directions, and there is a high risk of adhesive failure. In addition, the current catheter body 101 tends to be a slender structure, usually manufactured by extrusion. The extension tube 300 is usually inserted into the corresponding lumen and fixed by adhesive. There is a transition step at the insertion position, which makes the inside of the lumen less smooth, causing obstruction during instrument puncture and passage, and making it easy to scrape and get stuck.

[0079] Furthermore, due to the small diameter of the extension tube 300, which is typically used with guidewires or puncture needles with smaller outer diameters (0.5–1.2 mm), bonding it as an independent component would present the following problems: First, the bonding area is limited, making it difficult to guarantee bonding strength. With the capsule 201 inflated, the extension tube 300 must withstand axial and lateral loads, posing a risk of detachment. Second, the epoxies are brittle after curing, making them prone to aging and flaking after bonding. Under various loads transmitted from the extension tube 300 and alternating loads, these fragments are more likely to detach and enter the capsule 201, affecting the intraoperative field of vision. To address these issues, in this embodiment, the front connecting section 102 and the extension tube 300 are integrally molded, fundamentally avoiding the problems of weak bonding interfaces, detachment, or misalignment that may occur with independent bonding methods. Simultaneously, it ensures the coaxiality accuracy between the extension tube 300 and the main operating cavity 108, facilitating the smooth passage of puncture instruments. In addition, the integrated structure itself has higher load-bearing strength and will not produce adhesive layer debris entering the capsule 201 when bearing load, thus ensuring a better intraoperative field of vision.

[0080] The proximal end face of the front connecting section 102 and the distal end face of the main body section 107 are sealed and fixedly connected by an adhesive layer. The adhesive layer uses medical-grade adhesive, which is applied between the two end faces and cured to form a sealed structure. Its thickness is appropriate to ensure sufficient adhesive strength without forming obvious gaps at the connection.

[0081] The outer peripheral wall of the front connecting section 102 and the outer peripheral wall of the main body section 107 are smoothly connected. The pipe diameter is larger here, the bonding area is larger, and the bonding strength is better. The adhesive layer is also less likely to be damaged.

[0082] Based on any of the above-mentioned visualized intracardiac catheters, see [link / reference]. Figures 1 to 8 The present invention also provides a method for visualizing the foramen ovale puncture. This method includes the following steps.

[0083] The insertion and positioning procedure is as follows: The multi-lumen catheter 100 is inserted into the body through the femoral vein puncture point and, under X-ray guidance, is pushed along the inferior vena cava to the vicinity of the foramen ovale in the right atrium. During insertion, the inflatable capsule 201 remains in an emptied and contracted state to reduce the outer dimensions of the catheter 100.

[0084] Inflation procedure for capsule 201: Physiological saline is injected into the perfusion chamber 112 through the injection port. The saline solution passes through the adapter tubing 500 and the perfusion chamber 112 before entering the filling / draining chamber 204, causing the inflatable capsule 201 to slowly inflate. The inflated capsule 201 adheres to the edge of the fossa ovalis, stably fixing the tip of catheter 100 near the fossa ovalis. Simultaneously, the inflating of capsule 201 displaces the blood between the tip of catheter 100 and the fossa ovalis, creating a locally optically transparent area.

[0085] Image acquisition steps: The external light source and miniature camera assembly are activated. The illumination element transmits light to the third distal opening, illuminating the liquid environment within the filling / discharging chamber 204 and the foramen ovale tissue in front. The miniature camera assembly acquires optical images of the foramen ovale in real time through the second distal opening, and the image signal is transmitted to an external display device via image signal cable 701. The operator can directly observe the surface morphology, color, pulsation characteristics, and anatomical landmarks of the interatrial septum on the display screen.

[0086] Puncture localization procedure: Under visual guidance, the operator adjusts the angle and direction of catheter 100 so that the axis of the main operating chamber 108 is aligned with the center of the foramen ovale, and the cyst 201 is precisely recessed within the foramen ovale depression. After confirming the puncture point location, the puncture needle is inserted through operating port 407, passing through the main channel 406 and the main operating chamber 108, and extending out from the first distal opening 302 of extension tube 300. Under real-time video monitoring, the puncture needle is precisely inserted through the foramen ovale into the left atrium.

[0087] Sheath insertion into the left atrium: After successful puncture, the fluid in the sac 201 is aspirated, allowing the inflatable sac 201 to be emptied and closed. The catheter 100 and sheath are then pushed into the left atrium, and the sac 201 is refilled.

[0088] Guidewire placement procedure: After the sheath is inserted into the left atrium, the puncture needle is withdrawn, and the guidewire is advanced into the left atrium through the main operating chamber 108 along the puncture needle, leaving the guidewire and catheter 100 in place.

[0089] Subsequent procedures: Insert subsequent surgical instruments through the main operating chamber 108 along the guidewire to complete the corresponding treatment procedures.

[0090] Withdrawal procedure: After the procedure, the saline solution in the filling chamber 204 is withdrawn through the infusion port 112, allowing the inflatable capsule 201 to be emptied and closed. Then, the catheter 100 and guidewire are withdrawn from the body together.

[0091] The present invention also provides a method for assembling the above-mentioned catheter 100, see below. Figures 1 to 8 It includes the following steps: The first end of the capsule 201 is aligned and attached to the distal part of the catheter body 101, and a sealed connection between the first end of the capsule 201 and the distal part of the catheter body 101 is achieved by welding. The welding process can be laser welding, and a continuous sealing weld is formed on the mating surface after welding.

[0092] The proximal end of the extension tube 300 is fixed to the distal port of the main operating cavity 108 by adhesive bonding, so that the extension tube 300 is connected to the main operating cavity 108 and the distal end extends outward; the camera module 1092 and the illumination element are respectively assembled and fixed to the distal end of the imaging channel of the conduit body 101, and the cables of the two are led out from the proximal opening through the imaging channel. The second end of the capsule 201 is fitted and aligned to the distal part of the extension tube 300. The second end of the capsule 201 is sealed and fixed to the distal part of the extension tube 300 by welding, so that the capsule 201, the catheter body 101 and the extension tube 300 form a closed cavity structure. A guide tube with both rigid support and flexible bending performance is selected and passed through the far end opening of the connector 400 in reverse direction to the near end. After passing through the internal interface, both ends are exposed on both sides of the connector 400. The cables of the camera module 1092 and the lighting element are led out from the imaging channel and passed into the inside of the guide tube. Then the guide tube and the cable inside the tube are pulled back along the interface to complete the cable laying in the connector 400. Insert the guide wire 20 into the adapter hose 500, and insert the adapter hose 500 with the guide wire 20 attached into the proximal port of the infusion chamber 112. Fix it with instant adhesive. It should be noted that the adapter hose 500 needs to be positioned before applying the adhesive. Because of the size of the conduit 100, the size of the adapter hose 500 is also very small. The amount of adhesive applied is small and the adhesive layer is extremely thin. Therefore, the surface drying speed is extremely fast. It can usually harden on the surface within a few seconds and the adhesive will start to react. There is almost no operation window for the precise alignment required for extremely small workpieces. It is easy to stick them crookedly and scrap them.

[0093] Apply UV adhesive to the port of the infusion chamber 112 and cure it. After curing, pull out the guide wire 20, insert the guide wire 20 into the main channel 406 from the corresponding interface of the connector 400 in reverse and exit from the far end opening. Then reinsert the far end of the guide wire 20 into the adapter hose 500. Insert the positioning mandrel 30 into the tail end of the connector 400, and let the positioning mandrel 30 pass through the main channel 406 and exit from the distal opening of the connector 400. Insert the distal end of the positioning mandrel 30 into the main operating cavity 108 of the catheter body 101. Apply UV glue to the proximal end of the catheter body 101 and cure it to block the proximal cavity and reinforce the proximal end. Insert the positioning mandrel 30, the guide wire 20 and the proximal part of the catheter body 101 treated with instant glue into the distal opening of the connector 400 as a whole. Then, retract the positioning mandrel 30 along the corresponding cavity, retract the guide wire 20 along the second branch channel and retract the cable along the first branch channel until the catheter body 101 reaches the preset assembly position. UV adhesive is filled and compacted into the distal mating section of the adapter hose 500 and the second branch channel 410 to form a sealing layer. The water injection pipe 600 is inserted into the second branch channel 410 to achieve a sealed connection. The pipe joint 50 is sealed at the proximal end of the water injection pipe 600. The cable is led out through the first branch channel 409 and passed through the tail cable sleeve 800. The electrical connector 60 is connected at the proximal end of the tail cable sleeve 800.

[0094] This assembly method addresses the precision assembly requirements of small-diameter, multi-lumen interventional catheters 100. Through process optimization and tooling guidance, it effectively improves assembly accuracy and production yield while ensuring independent sealing and coaxiality of each lumen. The two ends of the capsule 201 are sealed and fixed to the catheter body and the extension tube 300 by welding, forming a continuous sealed weld. Compared with the adhesive sealing structure, it has better resistance to fluid erosion and long-term sealing stability, which can prevent leakage during the filling and discharging process. The step-by-step welding process makes it easier to control the assembly tension of the capsule 201 and ensure that the capsule 201 is filled in a uniform shape. The extension tube 300 and the optical components are pre-positioned and assembled at the remote end, which can ensure the coaxial guiding accuracy of the main operating cavity 108 and the imaging position accuracy of the camera module 1092 and the illumination element in advance, avoiding the remote functional end offset caused by the subsequent assembly process and ensuring the consistency of the finished product function.

[0095] The cable is reverse-threaded using a guide tube that combines rigid support and flexible bending performance, which can adapt to the narrow channel space inside the connector 400. During the threading process, the guide tube can protect the cable, preventing the cable from bending, jamming and tangling, and improving the neatness of the wiring inside the connector 400 and the assembly efficiency.

[0096] The 500 adapter hose adopts an assembly process of positioning first and then applying adhesive, which is suitable for precision assembly scenarios of small-sized pipe fittings. It effectively avoids the problems of insufficient alignment operation window and misaligned pipe fittings caused by the fast surface drying speed of instant adhesive. With the UV adhesive curing reinforcement at the 112 port of the injection chamber, it takes into account the bonding efficiency, port sealing reliability, and structural strength.

[0097] The positioning mandrel 30 and the guide wire 20 are used to guide the main operating cavity 108 and the injection cavity 112 respectively. During the final assembly, multiple cavities can be aligned synchronously to ensure the coaxiality of each cavity and effectively avoid assembly defects such as cavity misalignment and cross-cavity, thereby improving the consistency of batch assembly.

[0098] The adapter hose 500 and the second branch channel 410 are filled and sealed with UV glue, and are fixed together with the water injection pipe 600 to form a continuous and reliable liquid injection sealing circuit, which has a better sealing effect and is isolated from the main operating chamber. The cable is led out through the first branch channel 409 and connected to the tail cable sleeve 800 and the electrical connector 60. The wiring path is clear and the electrical connection is stable.

[0099] In some embodiments, in step S2, the adhesive method uses medical-grade epoxy adhesive, and the extension tube 300 is coaxially assembled with the port of the main operating cavity 108, with uniform adhesive thickness.

[0100] In step S7, the instant adhesive is medical-grade cyanoacrylate adhesive, and the pull-out force after the water injection tube 600 is bonded to the second branch channel 410 is not less than a preset threshold.

[0101] In some embodiments, in step S7, UV adhesive is injected into the gap between the adapter hose 500 and the second branch channel 410, and then the water injection pipe 600 is inserted, allowing the UV adhesive to overflow along the inner wall between the adapter hose 500 and the water injection pipe 600. Then, the distal section of the transparent water injection pipe 600 is cured by UV irradiation, so that a sealed connection is formed between the wall of the water injection pipe 600 and the inner wall of the second branch channel 410. At the same time, a sealed connection is formed between the adapter hose 500 and the inner wall of the water injection pipe 600, which can still achieve a good sealing effect even if the seal between the water injection pipe 600 and the second branch channel fails.

[0102] The above description is only a preferred embodiment of the present invention and does not limit the patent scope of the present invention. The present invention can also be used in interventional procedures such as Marshall vein ablation, left atrial appendage occlusion, and heart valve replacement in atrial fibrillation ablation. Any equivalent structural or procedural transformations made using the contents of the present invention's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A visual interventional medical catheter, characterized in that, include: The catheter body (101) has an axially extending main operating chamber (108), an infusion chamber (112) and an imaging channel inside. The distal end of the imaging channel is provided with an imaging component, and a cable adapted to the imaging component is laid in the imaging channel. A connecting seat (400) is connected to the proximal end of the catheter body (101) and has a channel that communicates with the proximal end of the main operating chamber (108), the perfusion chamber (112) and the imaging channel. An extension tube (300) is located at the distal end of the catheter body (101), coaxially connected with the main operating chamber (108), and its distal end protrudes from the distal end face of the catheter body (101). An inflatable sac (201), made of transparent material, is fitted onto the distal outer wall of the catheter body (101). Its proximal edge (202) is sealed to the outer wall of the catheter body (101), and its distal edge (203) is sealed to the outer wall of the extension tube (300), forming an inflatable / discharge chamber (204). The distal end of the extension tube (300) is provided with a first distal opening (302), which is located outside the distal end of the inflatable bladder (201) and communicates with the main operating chamber (108) for the passage of working instruments; the distal openings of the perfusion chamber (112) and the imaging channel are both located inside the filling and discharging chamber (204). The connecting seat (400) is provided with a main channel (406), and the proximal end of the catheter body (101) extends into the main channel (406) and is sealed to the main channel (406); the proximal end face of the connecting seat (400) is provided with an operation hole (407) communicating with the main channel (406), and the proximal part of the main channel (406) branches out to extend into a first branch channel (409) and a second branch channel (410). The imaging channel is connected to the first branch channel (409) through a lateral opening on the proximal sidewall of the catheter body (101), and the perfusion chamber (112) is connected to the second branch channel (410) through a lateral opening on the proximal sidewall of the catheter (100). The proximal end of the infusion chamber (112) is connected to a bendable adapter hose (500); the distal end of the adapter hose (500) is inserted into the infusion chamber (112), and its outer wall is sealed and fixed to the inner wall of the infusion chamber (112) by an annular adhesive layer. The port of the adapter hose (500) and the infusion chamber (112) is sealed with an annular UV adhesive. The proximal end of the adapter hose (500) passes through a lateral opening, a main channel (406) and a second branch channel (410) in sequence. The adapter hose (500) and the second branch channel (410) are sealed and connected by a filling layer (70) formed by filling UV adhesive. The distal end of the water injection pipe (600) is inserted and fixed inside the second branch channel (410), and its outer wall is bonded and fixed to the inner wall of the second branch channel (410); the proximal end of the adapter hose (500) extends into the inner cavity of the distal end of the water injection pipe (600).

2. The visual interventional medical catheter according to claim 1, characterized in that, The extension tube (300) is a transparent tube, the distal part of the extension tube (300) is arc-shaped, the proximal end of the extension tube (300) is inserted into the distal part of the main operating cavity (108), and the proximal end of the extension tube (300) forms a limiting shoulder.

3. The visual interventional medical catheter according to claim 1, characterized in that, The imaging channel includes an independent illumination cavity (110) and an imaging cavity (109), which are separated by the wall of the conduit body (101); a camera module (1092) is sealed at the second distal opening of the imaging cavity (109), and an illumination element (115) is sealed at the third distal opening of the illumination cavity (110). The imaging cavity (109) contains an image signal cable (701), and the illumination cavity (110) contains an illumination power supply cable (702). Both extend along the axial direction of the conduit body (101), pass through a lateral opening, the main channel (406), and the first branch channel (409) into the tail cable sleeve (800), and are led out from the proximal end of the tail cable sleeve (800).

4. The visual interventional medical catheter according to claim 1, characterized in that, The distal end of the water injection pipe (600) is a transparent connector end (601), and the distal portion of the adapter hose (500) extending out of the second branch channel (410) is sealed to the water injection pipe (600) by UV glue.

5. The visual interventional medical catheter according to claim 1, characterized in that, The distal end of the catheter body (101) is provided with a front end connecting section (102), which is integrally formed with the extension tube (300). Its proximal end is fixedly connected to the distal end of the main body (107) of the catheter body (101), so that the extension tube (300) and the main operating chamber (108) are coaxially connected. The proximal end face of the front end connecting section (102) and the distal end face of the main body (107) are sealed and fixed by an adhesive layer, and the outer peripheral walls of the two are smoothly connected.

6. A method for assembling a visual interventional medical catheter as described in any one of claims 1-4, characterized in that, Includes the following steps: S1. The first end of the capsule is aligned and attached to the distal part of the catheter body (101), and the first end of the capsule is sealed and fixed to the distal part of the catheter body (101) by welding. S2. The proximal end of the extension tube (300) is fixed to the distal port of the main operating cavity (108) by adhesive bonding, so that the extension tube (300) is connected to the main operating cavity (108) and the distal end extends outward; the camera module (1092) and the illumination element are respectively assembled and fixed to the distal port of the imaging channel of the conduit body (101), and the cables of the two are led out from the proximal opening through the imaging channel; S3. The second end of the capsule is fitted and aligned with the distal part of the extension tube (300). The second end of the capsule and the distal part of the extension tube (300) are sealed and fixed by welding, so that the capsule, the catheter body (101) and the extension tube (300) are enclosed to form a closed cavity structure. S4. Select a guide tube that combines rigid support and flexible bending performance, and run it from the far end opening of the connector (400) to the near end in reverse. After passing through the internal interface, both ends are exposed on both sides of the connector (400). Lead the cables of the camera module (1092) and the lighting element out from the imaging channel and run them into the inside of the guide tube. Then pull the guide tube and the cable inside the tube back along the interface to complete the cable routing in the connector (400). S5. Insert the guide wire (20) into the adapter hose (500), insert the adapter hose (500) with the guide wire (20) on it into the proximal port of the infusion chamber (112) as a whole, and fix it with instant adhesive; apply UV glue to the port of the infusion chamber (112) and cure it. After curing, pull out the guide wire (20), insert the guide wire (20) into the main channel (406) from the corresponding interface of the connector (400) in reverse and out from the far end opening, and then reinsert the far end of the guide wire (20) into the adapter hose (500); S6. Insert the positioning mandrel (30) into the tail end of the connector (400) until the positioning mandrel (30) passes through the main channel (406) and exits through the far end opening of the connector (400). Insert the far end of the positioning mandrel (30) into the main operating chamber (108) of the catheter body (101). Apply UV glue to the proximal end of the catheter body (101) and cure it. Insert the positioning mandrel (30), the guide wire (20) and the proximal part of the catheter body (101) treated with instant glue into the far end opening of the connector (400) as a whole. Then, retract the positioning mandrel (30) along the corresponding lumen, retract the guide wire (20) along the second branch channel, and retract the cable along the first branch channel until the catheter body (101) reaches the preset assembly position. S7. Fill the distal mating section of the adapter hose (500) and the second branch channel (410) with UV glue and compact it. Irradiate the branch channel opening with ultraviolet light to cure and form a sealing layer. Insert the water injection pipe (600) into the second branch channel (410) to achieve a sealed connection. Seal the connection pipe joint (50) at the near end of the water injection pipe (600). Lead the cable out through the first branch channel (409) and pass it through the tail cable sleeve (800). Connect the electrical connector (60) at the near end of the tail cable sleeve (800).

7. The method for assembling a visual interventional medical catheter according to claim 6, characterized in that, In steps S1 and S3, the welding process is laser welding, and a continuous sealed weld is formed on the mating surface after welding.

8. The method for assembling a visual interventional medical catheter according to claim 6, characterized in that, In step S7, UV glue is injected into the gap between the adapter hose (500) and the second branch channel (410), and then the water injection pipe (600) is inserted, so that the UV glue overflows along the inner wall between the adapter hose (500) and the water injection pipe (600). Then, the distal section of the transparent water injection pipe (600) is cured by UV irradiation, so that a sealed connection is formed between the pipe wall of the water injection pipe (600) and the inner wall of the second branch channel (410), and a sealed connection is formed between the adapter hose (500) and the inner wall of the water injection pipe (600).

Images