Visualizing 360° adjustable curve catheter sheath

Abstract

The application provides a visual 360-degree adjustable bending catheter sheath, which comprises a tube assembly, a visual assembly, a plurality of traction wires and a plurality of operating members, the tube assembly comprises an inner tube, an outer tube and a plurality of containing tubes, the outer tube is wrapped outside the inner tube, a plurality of containing tubes are arranged between the outer tube and the inner tube, and the plurality of containing tubes are arranged in a circumferential interval around the inner tube; the visual assembly is arranged at the distal end of the tube assembly; each traction wire is contained in a containing tube; the operating members are arranged at the proximal end of the tube assembly; the distal end of each traction wire is fixed to the distal end of the tube assembly, and the proximal end of the traction wire is connected to one operating member; the operating members can be independently operated to make the distal end of the tube assembly bend by tensioning or releasing the corresponding traction wire, can provide a real-time intravascular field of view for an operator in an interventional operation, and has a multi-directional precise bending adjustment capability.

Description

Technical Field

[0001] This invention relates to the field of catheter sheath technology, and more particularly to a visually adjustable 360° bendable catheter sheath. Background Technology

[0002] Percutaneous vascular intervention has become the mainstream minimally invasive method for treating cardiovascular, cerebrovascular, and peripheral vascular diseases. In this type of surgery, the catheter sheath is the basic instrument for establishing vascular access and providing a channel for subsequent treatment devices (such as catheters, guidewires, and stents).

[0003] To accommodate the natural tortuous anatomy of human blood vessels, the catheter sheath needs to be flexible. These devices typically use a traction wire embedded in the distal end of the sheath. By pulling on the proximal end, the distal end of the sheath is bent in a fixed direction, thus assisting in navigating some common vascular bends.

[0004] Most existing products can only achieve limited-angle bending within a single plane (such as upward / downward), and cannot perform flexible and precise directional adjustment in the entire circumference. When faced with complex three-dimensional vascular networks (such as aortic arch branches, cerebral vascular rings, etc.), their adaptability is poor, often requiring the replacement of different pre-shaped sheaths or spending a lot of time on repeated attempts, resulting in low surgical efficiency. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a 360° adjustable and visualized catheter sheath that can provide surgeons with a real-time intravascular view during interventional procedures and has multi-directional precise bending capabilities, thereby improving the accuracy and safety of the procedure.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A visualized 360° adjustable bendable catheter sheath, comprising:

[0008] A pipe assembly, comprising an inner pipe, an outer pipe, and a plurality of containment pipes, wherein the outer pipe wraps around the outside of the inner pipe, and a plurality of containment pipes are provided between the outer pipe and the inner pipe, the plurality of containment pipes being arranged circumferentially around the inner pipe;

[0009] A visualization component is located at the distal end of the tube component;

[0010] Multiple traction wires, each traction wire is housed within one of the aforementioned tubes;

[0011] Multiple operating elements are provided at the proximal end of the tube assembly;

[0012] The distal end of each of the traction wires is fixed to the distal end of the tube assembly, and the proximal end of the traction wire is connected to an operating element that can be operated independently to bend the distal end of the tube assembly by tensioning or releasing the corresponding traction wire.

[0013] In a preferred embodiment, in the region at the distal end of the tube assembly, the receiving tube has an inclined section that is connected to the outer wall of the inner tube.

[0014] The distal end of the traction wire is fixed within the inclined section of the container.

[0015] In a preferred embodiment, the distal end of the traction wire is connected to the distal end of the inner tube.

[0016] In a preferred embodiment, the operating element is a knob, which can be rotated to wind or release the corresponding traction wire.

[0017] In a preferred embodiment, the plurality of operating elements are arranged in at least two axially spaced rings near the proximal end of the outer tube, with the operating elements on each ring arranged circumferentially spaced, and the operating elements on adjacent rings being staggered circumferentially.

[0018] In a preferred embodiment, in its natural state, the line connecting the distal fixing point and the proximal connection point of each traction wire is approximately parallel to the axis of the tube assembly.

[0019] In a preferred embodiment, the visualization component includes:

[0020] A lens, wherein the lens is disposed at the distal end of the outer tube;

[0021] A light source, which is adjacent to the lens and located at the distal end of the outer tube;

[0022] A data cable is provided between the outer tube and the inner tube. One end of the data cable is connected to the lens and the light source, and the other end of the data cable passes through the proximal end of the outer tube.

[0023] In a preferred embodiment, the pipe assembly further includes:

[0024] A flushing tube is disposed between the outer tube and the inner tube, with the distal port of the flushing tube exposed to the distal end of the outer tube and facing the field of view of the visualization component, and the proximal port of the flushing tube exposed to the proximal end of the outer tube.

[0025] In a preferred embodiment, the distal end of the outer tube has a distal end face and a tapered inclined surface, the tapered inclined surface being connected between the distal end face and the tube body of the outer tube;

[0026] The distal port of the inner tube and the visualization component are located on the distal end face, and the distal port of the flushing tube is exposed on the tapered inclined surface.

[0027] Compared with existing technologies, this technical solution has the following advantages:

[0028] The design, which uses multiple traction wires and independent tubing, along with the circumferentially staggered layout of the operating components, allows for a bending angle range far exceeding that of traditional products (up to 360°), providing more precise control and easily handling complex vascular anatomy.

[0029] The independent tube design completely avoids traction wire entanglement, ensuring the independence and accuracy of bending control in all directions and improving the reliability of the instrument.

[0030] The visualization, bending, and flushing functions are highly integrated into a single catheter sheath, simplifying the surgical procedure and improving surgical efficiency and safety. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the structure of the 360° adjustable bendable catheter sheath described in this invention;

[0032] Figure 2 This is an exploded view of the 360° adjustable bendable catheter sheath described in this invention;

[0033] Figure 3 This is a schematic diagram of the structure of the distal end of the pipe assembly described in this invention;

[0034] Figure 4 This is a schematic diagram of the structure of the proximal end of the tube assembly described in this invention.

[0035] In the diagram: 100 tube assembly, 110 inner tube, 120 outer tube, 121a distal end face, 121b tapered slope, 130 container tube, 131 inclined section, 140 flushing tube, 141 nozzle, 142 liquid bottle, 200 visualization component, 210 lens, 220 light source, 230 data cable, 240 image processing unit, 300 traction wire, 400 operating component, 500 guide wire. Detailed Implementation

[0036] The following description is intended to disclose the present invention and enable those skilled in the art to implement it. The preferred embodiments described below are merely examples, and other obvious variations will occur to those skilled in the art. The basic principles of the invention defined in the following description can be applied to other embodiments, modifications, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the invention.

[0037] Please refer to Figures 1 to 3An embodiment of the present invention provides a visualized 360° adjustable bendable catheter sheath, comprising:

[0038] The tube assembly 100 includes an inner tube 110, an outer tube 120, and a plurality of receiving tubes 130. The outer tube 120 is wrapped around the outside of the inner tube 110. A plurality of receiving tubes 130 are provided between the outer tube 120 and the inner tube 110. The plurality of receiving tubes 130 are circumferentially spaced around the inner tube 110.

[0039] A visualization component 200 is disposed at the distal end of the tube assembly 100;

[0040] Multiple traction wires 300, each traction wire 300 is housed in a container tube 130;

[0041] Multiple operating elements 400 are provided at the proximal end of the tube assembly 100;

[0042] The distal end of each of the traction wires 300 is fixed to the distal end of the tube assembly 100, and the proximal end of the traction wire 300 is connected to an operating member 400, which can be operated independently to bend the distal end of the tube assembly 100 by tensioning or releasing the corresponding traction wire 300.

[0043] Traditional multi-traction wire designs typically place multiple wires directly in the same chamber, resulting in inherent drawbacks such as entanglement and low transmission efficiency. However, this embodiment fundamentally eliminates the possibility of entanglement by providing an independent housing 130 for each traction wire 300, thus laying the foundation for reliable and independent multi-degree-of-freedom bending.

[0044] Since each traction wire 300 moves within an independent conduit 130, when the operator tensions the traction wire 300 in a specific direction (such as the 12 o'clock direction) through the operating element 400, the tension can be directly transmitted to the distal end without loss or interference, driving the tube assembly 100 to produce precise and controllable directional bending. By selectively operating different circumferentially distributed traction wires 300, bending at any angle within the 360° full circumferential range of the distal end of the tube assembly 100 can be easily achieved.

[0045] In addition, the distal end of the tube assembly 100 in this embodiment is provided with a visualization component 200. This design allows the operator to simultaneously control the bending direction of the catheter sheath under the guidance of real-time direct visualization of the intravascular image, and to perform precise navigation and positioning.

[0046] like Figure 1 and Figure 2As shown, the tubing assembly 100 has a distal end and a proximal end disposed opposite each other along its axial direction. The distal end of the tubing assembly 100 is used for insertion into a patient's blood vessel during surgery, while the proximal end of the tubing assembly 100 remains outside the body for manipulation by the surgeon.

[0047] The inner wall of the inner tube 110 is smooth, allowing interventional instruments such as guidewires 500, catheters, balloons, and stents to pass smoothly. The inner tube 110 can be made of polytetrafluoroethylene (PTFE) or high-density polyethylene (HDPE).

[0048] The outer tube 120 covers the outside of the inner tube 110 and is made of a flexible, biocompatible material to ensure smooth passage through blood vessels. For example, polytetrafluoroethylene (PTFE) is used.

[0049] The distal end of the outer tube 120 and the distal end of the inner tube 110 are sealed and fused together by means of heat fusion, laser welding, or bonding, so that only the distal end of the inner tube 110 is exposed. Similarly, the proximal end of the outer tube 120 and the proximal end of the inner tube 110 are also sealed and fused together in a similar manner, with only the proximal end of the inner tube 110 exposed. The instrument is inserted through the proximal end of the inner tube 110 and exits through the distal end of the inner tube 110 to perform the interventional procedure.

[0050] Thus, a closed annular cavity is formed between the outer tube 120 and the inner tube 110, which is used to accommodate the plurality of accommodating tubes 130, the data cable 230 of the visualization component 200, and the flushing tube 140, etc.

[0051] like Figures 1 to 3 As shown, the container 130 is made of a flexible polymer material (such as polyurethane, polyethylene, etc.). Each container 130 has a traction wire 300 arranged inside it to isolate the traction wires 300 from each other, thereby fundamentally preventing them from tangling, rubbing, or knotting during operation.

[0052] In one embodiment, the receiving tube 130 is not rigidly connected to the inner tube 110 and the outer tube 120. The distal end of the traction wire 300 is directly fixedly connected to the outer wall of the distal end of the inner tube 110, and the proximal end of the traction wire 300 is directly connected to the operating member 400, which is located at the proximal end of the outer tube 120. When the operator tensions a particular traction wire 300 using the operating member 400, the tension acts directly on the distal end of the inner tube 110, driving the inner tube 110 to bend in the direction of that traction wire. Because the distal ends of the inner tube 110 and the outer tube 120 are fixedly connected, the outer tube 120 will undergo coordinated bending deformation with the inner tube 110, thereby achieving precise directional bending of the distal end of the entire tube assembly 100.

[0053] In another embodiment, the distal end of the container 130 is connected to the outer wall of the distal end of the inner tube 110, for example, by bonding with a medical-grade adhesive or by micro-thermal welding. The distal end of the traction wire 300 is fixedly connected to the interior of the distal end of the container 130. When the operator tensions the traction wire 300, the tension is first transmitted to the distal end of the container 130, and then indirectly applied to the inner tube 110 through the connection point between the distal end of the container 130 and the outer wall of the inner tube 110, thereby driving it to bend.

[0054] Preferably, refer to Figure 3 In the region at the distal end of the tube assembly 100, the container 130 has an inclined section 131, the distal end of which is fixedly connected to the outer wall of the inner tube 110, and the proximal end of which smoothly transitions to the tube body of the container 130, so that the container 130 naturally connects to the outer wall of the inner tube 110 from the radially outer side.

[0055] In this preferred embodiment, the distal end of the traction wire 300 is fixedly connected to the interior of the distal end of the container 130, and a relatively long portion is covered and fixed within the inclined section 131. When the operator tensions the traction wire 300, the tension is first transmitted to the distal end of the container 130, and then through the connection point between the distal end of the container 130 and the outer wall of the inner tube 110, the tension is finally applied to the inner tube 110, thereby driving it to bend.

[0056] The design of this inclined section 131 significantly increases the fixed contact area and mechanical interlocking effect between the traction wire 300 and the tube 130, effectively preventing the traction wire 300 from falling off during repeated tensioning. In addition, this structure more effectively converts the tension of the traction wire 300 into a moment that bends the tube, with a direct and smooth force transmission path, reducing energy loss and improving the sensitivity and accuracy of the bending response.

[0057] The traction wire 300 can be made of metal materials such as stainless steel and nickel-titanium alloy, or high molecular weight fiber materials such as ultra-high molecular weight polyethylene.

[0058] like Figure 1 As shown, a mounting hole is provided at the proximal end of the outer tube 120, and each mounting hole corresponds to one of the operating elements 400. The proximal port of each receiving tube 130 extends to and is adjacent to the mounting hole.

[0059] In one embodiment, the operating element 400 is a knob, which is rotatably disposed within the mounting hole. The head of the operating element 400 is located outside the outer tube 120 for easy operation by the operator; its tail extends into the outer tube 120 and is connected to the proximal end of the traction wire 300.

[0060] When the head of the operating member 400 is rotated clockwise or counterclockwise, its tail rotates accordingly, thereby winding or unwinding the proximal end of the corresponding traction wire 300, thus achieving tension and relaxation control of the traction wire 300.

[0061] like Figure 1 and Figure 4 As shown, the plurality of operating elements 400 are arranged in at least two rings spaced apart axially at the proximal end of the outer tube 120, with the operating elements 400 on each ring arranged circumferentially spaced apart, and the operating elements 400 on adjacent rings being staggered circumferentially.

[0062] In one embodiment, the number of traction wires 300 and operating elements 400 is eight, with the eight operating elements 400 arranged in two circles, four in each circle. They are evenly distributed circumferentially and the two circles are staggered by 45 degrees. This arrangement allows the eight operating elements to precisely correspond to eight different circumferential bending directions.

[0063] In its natural state, the line connecting the distal fixing point of each of the traction wires 300 and the proximal connection point on the operating member 400 is approximately parallel to the axis of the tube assembly 100. Therefore, when an operating member 400 is operated to tension its corresponding traction wire 300, the distal end of the tube assembly 100 can be effectively driven to bend in the circumferential direction of the traction wire 300.

[0064] like Figure 1 and Figure 2 As shown, the visualization component 200 includes:

[0065] Lens 210, wherein the lens 210 is disposed at the distal end of the outer tube 120;

[0066] Light source 220, which is adjacent to lens 210 and located at the distal end of outer tube 120;

[0067] Data cable 230 is disposed between the outer tube 120 and the inner tube 110. One end of the data cable 230 is connected to the lens 210 and the light source 220, and the other end of the data cable 230 passes through the proximal end of the outer tube 120.

[0068] The lens 210 is used to acquire optical images, and the light source 220 is used to provide illumination. The light source 220 is a high-intensity LED cold light source to adapt to the narrow space inside the cavity and avoid tissue thermal damage. The other end of the data cable 230 passes through the proximal end of the outer tube 120 and is connected to an external host for displaying and analyzing the images acquired by the lens 210, achieving the effect of visual angiography.

[0069] The visualization component 200 also includes an image sensor and an image processing unit 240. The image sensor is located behind the lens 210 and is preferably a CMOS sensor with micron-level pixel units. It is used to convert optical images into electrical signals. The image processing unit 240 is connected to the image sensor and the light source 220 through a flexible circuit. The image processing unit integrates at least a control chip for noise reduction and color correction processing of the raw image data output by the image sensor.

[0070] like Figure 1 and Figure 3 As shown, the pipe assembly 100 further includes:

[0071] A flushing tube 140 is disposed between the outer tube 120 and the inner tube 110. The distal port of the flushing tube 140 is exposed to the distal end of the outer tube 120 and faces the field of view of the visualization component 200. The proximal port of the flushing tube 140 is exposed to the proximal end of the outer tube 120 and is used to connect to an external flushing fluid source.

[0072] During operation, the proximal port of the flushing tube 140 is connected to a liquid bottle 142 containing flushing fluid such as saline. The flushing fluid is sprayed out from the distal port of the flushing tube 140 to flush bloodstains or other obstructions in the field of view in front of the lens 210, thereby keeping the lens 210 clean and the field of view clear in complex vascular environments.

[0073] The distal end of the flushing tube 140 is fitted with a nozzle 141, which is fixedly installed at the distal end of the flushing tube 140 or directly integrated with the distal wall of the outer tube 120. The nozzle 141 is configured to diffuse the outflowing flushing fluid into a mist or form a cone-shaped water flow at a specific angle, thereby expanding the flushing area and cleaning the lens 210 surface efficiently and gently, avoiding impact on the blood vessel wall.

[0074] like Figure 1 As shown, the distal end of the outer tube 120 has a distal end face 121a and a tapered inclined surface 121b, and the tapered inclined surface 121b connects the distal end face 121a and the tube body 122 of the outer tube 120.

[0075] The distal end face 121a is substantially perpendicular to the axis of the tube assembly 100, and the distal port of the inner tube 110 and the visualization component 200 are integrated onto the distal end face 121a. This arrangement ensures the straightness of the inner tube 110 as an instrument channel, while providing the visualization component 200 with optimal forward field of view. Miniaturized modules such as the lens 210 and the light source 220 are encapsulated in medical-grade epoxy resin on the distal end face 121a to ensure sealing and biocompatibility.

[0076] The distal port of the flushing pipe 140 is located on the tapered inclined surface 121b. This non-coplanar layout effectively utilizes the radial dimension of the distal space and avoids interference with the core components on the end face 121a.

[0077] The practical method for describing the visualized 360° adjustable bendable catheter sheath is as follows:

[0078] Assess the patient and confirm the surgical plan. Check that the product is functioning properly, connect data cable 230 to the external host, and connect the proximal end of irrigation tube 140 to saline solution.

[0079] With the aid of X-ray fluoroscopy, the catheter sheath is advanced along the guidewire 500 to the vicinity of the target blood vessel area.

[0080] For a clear view, an occlusion balloon can be inserted through the inner tube 110 of the catheter sheath to the area in front of the target region, and the balloon can be inflated to temporarily block blood flow. Then, turn on the light source 220 and the flushing function to rinse away any blood in front of the lens.

[0081] Observe the real-time images displayed on the main unit. By rotating the operating piece 400 to different circumferential positions, precisely adjust the bending angle and direction of the distal end of the catheter sheath to reach the optimal observation position or pass through tortuous blood vessels.

[0082] The treatment device (such as a stent, coil, etc.) is delivered to the lesion site through the device channel of the inner tube 110, and the release or treatment operation is completed under real-time direct vision.

[0083] After the procedure, remove all instruments and the catheter sheath, and treat the puncture site.

[0084] The embodiments described above are only used to illustrate the technical ideas and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly. The scope of patent application of the present invention should not be limited by these embodiments. That is, any equivalent changes or modifications made in accordance with the spirit disclosed in the present invention still fall within the patent scope of the present invention.

Claims

1. A visual 360° adjustable curve catheter sheath characterized by, The utility model relates to a medical device, and more particularly to a medical device for endoscopy. The medical device comprises: a tube assembly (100) comprising an inner tube (110), an outer tube (120) and a plurality of containment tubes (130), the outer tube (120) being wrapped around the outer portion of the inner tube (110), the plurality of containment tubes (130) being arranged circumferentially and spaced apart between the outer tube (120) and the inner tube (110); a visualization assembly (200) arranged at the distal end of the tube assembly (100); a plurality of traction wires (300), each of which is accommodated in one of the containment tubes (130); a plurality of operation members (400) arranged at the proximal end of the tube assembly (100); wherein the distal end of each of the traction wires (300) is fixed to the distal end of the tube assembly (100), and the proximal end of each of the traction wires (300) is connected to one of the operation members (400), each of the operation members (400) being independently operable to bend the distal end of the tube assembly (100) by tensioning or releasing the corresponding traction wire (300); in the region of the distal end of the tube assembly (100), the containment tubes (130) have an inclined section (131) connected to the outer wall of the inner tube (110); the distal end of each of the traction wires (300) is fixed to the inclined section (131) of the containment tube (130); 2. The visualizing 360° adjustable curve catheter sheath of claim 1, wherein, in the natural state, the line connecting the fixing point at the distal end and the connection point at the proximal end of each of the traction wires (300) is substantially parallel to the axis of the tube assembly (100).

3. The visualizing 360° adjustable curve catheter sheath of claim 1, wherein, the distal end of each of the traction wires (300) is connected to the distal end of the inner tube (110).

4. The visualizing 360° adjustable curve catheter sheath of claim 1, wherein, each of the operation members (400) is a knob, and rotating the knob can wind or release the corresponding traction wire (300).

5. The visualizing 360° adjustable curve catheter sheath of claim 1, wherein, the plurality of operation members (400) are arranged in at least two turns spaced apart in the axial direction at the proximal end of the outer tube (120), the operation members (400) in each turn are arranged in the circumferential direction, and the operation members (400) in adjacent turns are arranged in the circumferential direction with a displacement. the visualization assembly (200) comprises: a lens (210) arranged at the distal end of the outer tube (120); a light source (220) adjacent to the lens (210) and arranged at the distal end of the outer tube (120); 6. The visualizing 360° adjustable curve catheter sheath of claim 1, wherein, a data line (230) arranged between the outer tube (120) and the inner tube (110), one end of the data line (230) being connected to the lens (210) and the light source (220), and the other end of the data line (230) being arranged to pass out of the proximal end of the outer tube (120). the tube assembly (100) further comprises: A flushing tube (140) is provided between the outer tube (120) and the inner tube (110), a distal end port of the flushing tube (140) is exposed to a distal end of the outer tube (120) and faces a visual field direction of the visualization assembly (200), and a proximal end port of the flushing tube (140) is exposed to a proximal end of the outer tube (120).

7. The visualizing 360° adjustable curve catheter sheath of claim 6, wherein, A distal end of the outer tube (120) has a distal end face (121a) and a tapered slope (121b) connected between the distal end face (121a) and a tube body (122) of the outer tube (120); The distal end port of the inner tube (110) and the visualization assembly (200) are provided on the distal end face (121a), and the distal end port of the flushing tube (140) is exposed on the tapered slope (121b).

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