Single lumen balloon catheter

Abstract

The present application is a kind of single lumen balloon catheter, which comprises a single lumen tube and a lining rod, the inside of the single lumen tube is formed with a lumen along its axial direction, a balloon is arranged on the single lumen tube and communicates with the lumen, the lining rod is movably arranged in the lumen along the axial direction of the single lumen tube, one end of the single lumen tube is provided with a first port for controlling the position of the lining rod and a second port for injecting liquid into the lumen to inflate the balloon, and the other end of the single lumen tube is formed with a pointed end; the lining rod is pushed inward to move in the lumen to a position close to the pointed end; the lining rod is pulled outward to move in the lumen to a position away from the pointed end in the direction of the first port. The balloon catheter in the present application has better control performance and passing performance, improves the convenience of balloon delivery and the accuracy of positioning, and effectively improves the success rate of clinical operation.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a single-lumen balloon catheter. BACKGROUND

[0002] At present, balloon catheters are increasingly used to treat various diseases by being introduced into the rectal cavity, uterine cavity, biliary tract cavity, urinary tract cavity, joint cavity, brain ventricle cavity, throat cavity, etc. of a patient. When a balloon catheter is used in clinical practice to treat diseases in a cavity, accurate positioning of the target lesion site and accurate expansion are very important. The most commonly used method is to perform direct positioning and expansion operation treatment under endoscopy. The most commonly used endoscopes in clinical practice include laparoscopes, cystoscopes, hysteroscopes, arthroscopes and ventriculoscopes, etc. Endoscopes are divided into two categories: rigid endoscopes and flexible endoscopes. When treating a disease, the operator first transports the endoscope to the vicinity of the lesion site, observes the lesion, and then transports the instruments to the distal end of the instrument channel of the endoscope through the instrument operation channel of the endoscope. The instruments are then pushed out of the instrument channel and transported to the distal lesion site. However, the instrument channel of the endoscope can only provide a small outer diameter, which can only be used as a transport channel for small-diameter instruments such as biopsy forceps and injection needles.

[0003] Balloon catheters used in clinical practice are divided into multi-lumen (or multi-cavity) balloon catheters and single-lumen balloon catheters. Multi-lumen (or multi-cavity) balloon catheters are used in clinical practice in cooperation with guide wires, and have good tracking performance and control performance. However, due to the large size of the outer diameter of the shaft of the multi-lumen (or multi-cavity) balloon catheter, it cannot be transported through the instrument channel of the endoscope. Therefore, the "guide wire guided parallel insertion" method is often used for transportation and positioning, i.e. the endoscope and the balloon catheter are transported in a parallel insertion manner under the guidance of the guide wire. This method not only has a high degree of difficulty, but also increases the risk and degree of damage to the human body cavity, causing severe discomfort and pain to the patient after the operation, reducing the success rate of clinical surgery, and increasing the economic burden of the patient. The single-lumen balloon catheter has a single shaft structure design, and the outer diameter of the shaft is small, so it can enter the instrument channel of the endoscope. However, the single shaft structure design results in poor distal control and passability, and the use effect is not reasonable.

[0004] Therefore, the present application is proposed by the present inventor based on years of experience and practice in the relevant industry to overcome the defects of the prior art. SUMMARY

[0005] The present application aims to provide a single-lumen balloon catheter that can be transported to the lesion site of a patient through the instrument channel of a conventional endoscope. The coaxial gradually changing adjustable lining rod arranged inside the balloon catheter can improve the control and passability of the distal end of the balloon catheter, and has excellent clinical application value.

[0006] The object of the present application can be achieved by the following technical solutions:

[0007] This invention provides a single-lumen balloon catheter, which includes a single-lumen tube and an inner rod. The single-lumen tube has a cavity formed along its axial direction inside. A balloon communicating with the cavity is disposed on the single-lumen tube. The inner rod is movably disposed within the cavity along the axial direction of the single-lumen tube. One end of the single-lumen tube has a first port for controlling the position of the inner rod and a second port for injecting liquid into the cavity to inflate the balloon. The other end of the single-lumen tube has a pointed tip.

[0008] Push the inner liner rod inward to move it within the cavity to a position close to the tip;

[0009] Pull the inner liner rod outward to move it within the cavity toward the first opening to a position away from the tip.

[0010] In a preferred embodiment of the present invention, the balloon is disposed on the single-lumen tube and near the tip, the interior of the balloon is connected to the cavity, and liquid is injected into the cavity to inflate the balloon.

[0011] In a preferred embodiment of the present invention, the single-lumen tube passes through the balloon, and at least one liquid inlet is provided on the single-lumen tube to connect the cavity with the inside of the balloon, so that the liquid injected into the cavity enters the inside of the balloon.

[0012] In a preferred embodiment of the present invention, the balloon includes an expansion section and a first end and a second end located on both sides of the expansion section in the axial direction of the single-lumen tube. The balloon is connected to the single-lumen tube through the first end and the second end. When liquid is injected into the balloon, only the expansion section is in an expanded state among the expansion section, the first end and the second end.

[0013] In a preferred embodiment of the present invention, the surface of the expansion segment or a portion thereof is coated with a drug layer.

[0014] In a preferred embodiment of the present invention, the single-lumen tube sequentially comprises a first single-lumen tube segment, a second single-lumen tube segment, and a third single-lumen tube segment along its axial direction. The first port and the second port are both located at one end of the first single-lumen tube segment. The other end of the first single-lumen tube segment is connected to one end of the second single-lumen tube segment. The other end of the second single-lumen tube segment is connected to one end of the third single-lumen tube segment. The tip is located at the other end of the third single-lumen tube segment. The hardness of the first single-lumen tube segment and the hardness of the second single-lumen tube segment are greater than the hardness of the third single-lumen tube segment.

[0015] The balloon is located on the second single-lumen tube segment and away from one side of the first single-lumen tube segment.

[0016] In a preferred embodiment of the present application, the third single-lumen tube segment has an axial length of 3mm to 50mm along the single-lumen tube.

[0017] In a preferred embodiment of the present application, the third single-lumen tube segment has an axial length of 15mm to 50mm along the single-lumen tube.

[0018] In a preferred embodiment of the present application, the tip portion has a closed arc structure.

[0019] In a preferred embodiment of the present application, the inner liner rod comprises a first inner liner rod segment away from the tip portion and a second inner liner rod segment close to the tip portion, the first inner liner rod segment has a straight rod structure extending axially along the single-lumen tube.

[0020] The second inner liner rod segment further comprises a variable-diameter segment and a straight segment, one end of the variable-diameter segment is connected to the first inner liner rod segment, the other end of the variable-diameter segment is connected to the straight segment, the variable-diameter segment has a tapered rod structure with a gradually decreasing radius from away from the tip portion to close to the tip portion.

[0021] In a preferred embodiment of the present application, the straight segment is provided with a developing wire.

[0022] In a preferred embodiment of the present application, the developing wire is spirally wound and fixed on the straight segment.

[0023] In a preferred embodiment of the present application, the single-lumen balloon catheter comprises a handle, the handle is connected to one end of the single-lumen tube away from the tip portion, the first port and the second port are both located on the handle, and the first port, the single-lumen tube and the inner liner rod are coaxially arranged.

[0024] In a preferred embodiment of the present application, the first port is provided with an inner liner rod base capable of sealing and plugging the first port, and one end of the inner liner rod away from the tip portion is connected to the inner liner rod base.

[0025] From the above, the single-lumen balloon catheter of the present application has the following features and advantages: an inner lining rod is arranged in the inner lumen of the single-lumen tube and can move along the axial direction of the single-lumen tube. During use, the position of the inner lining rod in the lumen can be adjusted. When the balloon catheter needs to pass through a curved and narrow human body lumen, the inner lining rod can be pulled outward so as to move in the lumen away from the tip of the single-lumen tube, thereby improving the bending and deformation ability of the distal end of the single-lumen tube, increasing the success rate of the balloon catheter passing through the curved and narrow position, and reducing the damage to the human body lumen. When the balloon catheter is accurately positioned at the lesion site, the inner lining rod can be pushed inward so as to move in the lumen close to the tip of the single-lumen tube, thereby improving the support performance of the balloon during expansion, and achieving good treatment effect. The single-lumen balloon catheter of the present application has only one lumen, which can be delivered to the lesion site of the patient through the conventional endoscope instrument channel. The arrangement of the movable inner lining rod improves the controllability and passing performance of the distal end of the balloon catheter, and has excellent clinical application value. BRIEF DESCRIPTION OF DRAWINGS

[0026] The following drawings are only intended to illustrate and explain the present application, and do not limit the scope of the present application.

[0027] Among them:

[0028] Figure 1 : is a structural schematic diagram of the single-lumen balloon catheter of the present application.

[0029] Figure 2 : is a structural schematic diagram of the inner lining rod in the single-lumen balloon catheter of the present application.

[0030] Figure 3 : is a schematic diagram of the position of the developing wire in the single-lumen balloon catheter of the present application.

[0031] Figure 4 : is a structural schematic diagram of the developing wire in the single-lumen balloon catheter of the present application.

[0032] Figure 5 : is one of the structural schematic diagrams of the balloon in the single-lumen balloon catheter of the present application.

[0033] Figure 6 : is the second structural schematic diagram of the balloon in the single-lumen balloon catheter of the present application.

[0034] Figure 7 : is the third structural schematic diagram of the balloon in the single-lumen balloon catheter of the present application.

[0035] The reference numerals in the present application are:

[0036] 1, balloon; 101, inflation section;

[0037] 102, first end; 103, second end;

[0038] 2, single lumen tube; 201, first single lumen tube segment;

[0039] 202, second single lumen tube segment; 203, third single lumen tube segment;

[0040] 204, tip portion; 205, lumen;

[0041] 206, liquid inlet hole; 3, inner liner rod;

[0042] 301, first inner liner rod segment; 302, second inner liner rod segment;

[0043] 3021, variable diameter segment; 3022, straight segment;

[0044] 303, developing wire; 304, inner liner rod base;

[0045] 4, handle; 401, first port;

[0046] 402, second port. DETAILED DESCRIPTION

[0047] In order to have a clearer understanding of the technical features, objectives and effects of the present application, the specific embodiments of the present application will be described with reference to the accompanying drawings.

[0048] As shown in Figure 1 The present application provides a single lumen balloon catheter, which comprises a single lumen tube 2 and an inner liner rod 3, the inside of the single lumen tube 2 is formed with a lumen 205 along the axial direction of the single lumen tube 2, the single lumen tube 2 is provided with a balloon 1 in communication with the lumen 205, the inner liner rod 3 is movably arranged in the lumen 205 along the axial direction of the single lumen tube 2, one end of the single lumen tube 2 is provided with a first port 401 and a second port 402, the position of the inner liner rod 3 in the lumen 205 can be controlled through the first port 401, and liquid can be injected into the lumen 205 through the second port 402 to make the balloon 1 expand and dilate, the surface of the balloon 1 is in contact with the lesion site of the patient to achieve the purpose of treating the lesion site, the other end of the single lumen tube 2 is formed with a tip portion 204; the inner liner rod 3 is pushed inward to move in the lumen 205 to a position close to the tip portion 204; the inner liner rod 3 is pulled outward to move in the lumen 205 to a position away from the tip portion 204.

[0049] The present application is provided with an inner lining rod 3 which can move along the axial direction of the single-lumen tube 2 in the inner cavity 205 of the single-lumen tube 2. During use, the position of the inner lining rod 3 in the cavity 205 can be adjusted. When the balloon catheter needs to pass through the curved and narrow human body cavity, the inner lining rod 3 can be pulled outward to move in the cavity 205 away from the tip portion 204 of the single-lumen tube 2, thereby improving the bending and deformation ability of the distal end of the single-lumen tube 2, increasing the success rate of the balloon catheter smoothly passing through the curved and narrow position, and reducing the damage to the human body cavity. When the balloon catheter is accurately positioned at the lesion site, the inner lining rod 3 can be pushed inward to move in the cavity 205 close to the tip portion 204 of the single-lumen tube 2, thereby improving the support performance of the balloon 1 in the expanded state, and achieving good treatment effect. The single-lumen balloon catheter of the present application is provided with only one cavity 205, which can be delivered to the lesion site of the patient through the conventional endoscope instrument channel. The arrangement of the movable inner lining rod 3 improves the controllability and passing performance of the distal end of the balloon catheter, and has excellent clinical application value.

[0050] In an optional embodiment of the present application, as shown in Figure 1 The balloon 1 is arranged on the single-lumen tube 2 and close to the tip portion 204. The interior of the balloon 1 is in communication with the cavity 205. By injecting liquid into the cavity 205 through the second port 402, the balloon 1 can be inflated and expanded.

[0051] Further, as shown in Figure 1 The single-lumen tube 2 passes through the balloon 1. At least one liquid inlet hole 206 is arranged on the single-lumen tube 2 and opposite to the balloon 1. The liquid inlet hole 206 connects the cavity 205 and the interior of the balloon 1, so that the liquid injected into the cavity 205 can enter the interior of the balloon 1 through the liquid inlet hole 206. Of course, multiple liquid inlet holes 206 can be arranged according to the actual situation, and the arrangement position of the liquid inlet hole 206 can be adjusted to ensure that the cavity 205 and the interior of the balloon 1 are in communication and the liquid can uniformly and smoothly fill the interior of the balloon 1. The specific number and position of the liquid inlet hole 206 are not limited.

[0052] Further, as shown in Figure 1 The balloon 1 includes an inflation section 101 and first and second end portions 102 and 103 located on both sides of the inflation section 101 in the axial direction of the single-lumen tube 2. The balloon 1 is connected to the single-lumen tube 2 through the first and second end portions 102 and 103. When liquid is injected into the balloon 1, only the inflation section 101 is in an inflated and expanded state among the inflation section 101, the first end portion 102 and the second end portion 103. The inflation section 101 can withstand a pressure greater than or equal to 3 atm. The first and second end portions 102 and 103 do not have obvious inflation deformation.

[0053] In an optional embodiment of the present invention, the surface of the expansion segment 101 or a portion thereof is coated with a drug layer to deliver a targeted drug to the lesion site for treatment.

[0054] In an optional embodiment of the present invention, the balloon 1 may be made of a single-layer polymer material. The single-layer polymer material may be, but is not limited to, one of silicone, silicone rubber, polyurethane, PVC, polyether polyamide copolymer, nylon, or modified nylon, or a combination of the above materials.

[0055] In another optional embodiment of the invention, the balloon 1 may be made of multiple layers of rigid materials. The rigid materials may be, but are not limited to, at least two of silicone, silicone rubber, polyurethane, PVC, polyether polyamide copolymer, nylon, and modified nylon, and the different rigid materials may be arranged in a layered structure.

[0056] In an optional embodiment of the present invention, such as Figure 5 to Figure 7 As shown, the shape of balloon 1 (or balloon 1 in its inflated state) can be, but is not limited to, cylindrical or conical. Of course, balloon 1 in its inflated state can also be other irregular columnar structures (such as...). Figure 7 The specific shape of the balloon 1 is not limited here. (The structure is dumbbell-shaped with large diameters at both ends and small diameter in the middle.)

[0057] In an optional embodiment of the present invention, such as Figure 1 As shown, the single-lumen tube 2 includes a first single-lumen tube segment 201, a second single-lumen tube segment 202, and a third single-lumen tube segment 203 along its axial direction. The first port 401 and the second port 402 are both located at one end (proximal end) of the first single-lumen tube segment 201. The other end (distal end) of the first single-lumen tube segment 201 is connected to one end (proximal end) of the second single-lumen tube segment 202. The other end (distal end) of the second single-lumen tube segment 202 is connected to one end (proximal end) of the third single-lumen tube segment 203. The tip 204 is located at the other end (distal end) of the third single-lumen tube segment 203. The balloon 1 is located on the second single-lumen tube segment 202 and on the side away from the first single-lumen tube segment 201. The hardness of the first single-lumen tube segment 201 and the second single-lumen tube segment 202 is greater than that of the third single-lumen tube segment 203. During the surgery, the third single-lumen tube segment 203 and the tip 204 are adjusted and provided with basic mechanical support by mechanically manipulating the first single-lumen tube segment 201 and the second single-lumen tube segment 202 (including rotation, bending, and pulling). The proximal end is the end closer to the operator, and the distal end is the end farther from the operator.

[0058] In an optional embodiment of the present application, the single-lumen tube 2 is made of medical plastic, and the hardness of the single-lumen tube 2 made of medical plastic is greater than or equal to 70D. The medical plastic can be, but is not limited to, one of hard nylon, nylon / fiber copolymer or blend, polyether ether ketone, polyformal resin, high-density polyethylene, or high-density polypropylene, or a combination of the above materials.

[0059] In an optional embodiment of the present application, the single-lumen tube 2 is made of medical metal material. The medical metal material can be, but is not limited to, stainless steel or alloy material.

[0060] Further, the single-lumen tube 2 can also be made in the form of a combination of medical plastic and metal material, so as to further improve the hardness of the single-lumen tube 2. The medical plastic and metal material can be connected in a segmented combination or the medical plastic layer is covered on the surface of the metal material layer in a laminated form.

[0061] Further, among the first single-lumen tube segment 201, the second single-lumen tube segment 202, and the third single-lumen tube segment 203, at least the third single-lumen tube segment 203 is made of medical plastic, so that the hardness of the third single-lumen tube segment 203 is less than that of the first single-lumen tube segment 201 and the second single-lumen tube segment 202, so that the third single-lumen tube segment 203 has better bending performance and can adapt to the complex curved lumen structure of the human body, so as to ensure that the balloon catheter has better lumen bending degree and tracking performance.

[0062] The medical plastic used in the third single-lumen tube segment 203 can be, but is not limited to, polyether polyamide copolymer, nylon, or modified nylon, or a combination of the above materials.

[0063] In an optional embodiment of the present application, the third single-lumen tube segment 203 has an axial length of 3mm to 50mm along the single-lumen tube 2. Preferably, the third single-lumen tube segment 203 has an axial length of 15mm to 50mm along the single-lumen tube 2. This ensures that the balloon catheter can adapt to the bending angle of different human body lumens, quickly deform feedback to the protruding objects on the lumen surface, improve the success rate of one-time passing through the curved narrow lumen in the surgical process, and reduce the damage to the lumen mucosa caused by repeated passing.

[0064] In an optional embodiment of the present application, the tip portion 204 is in a sealed circular arc structure, which can effectively reduce the damage to the human body lumen mucosa during the transportation of the balloon catheter in the human body lumen.

[0065] In an optional embodiment of the present application, as shown in Figure 1 to Figure 3As shown in the figure, the inner lining rod 3 comprises a first inner lining rod segment 301 away from the tip portion 204 and a second inner lining rod segment 302 close to the tip portion 204, the first inner lining rod segment 301 is a straight rod structure extending along the axial direction of the single lumen tube 2; the second inner lining rod segment 302 further comprises a variable diameter segment 3021 and a straight segment 3022, one end of the variable diameter segment 3021 is connected with the first inner lining rod segment 301, the other end of the variable diameter segment 3021 is connected with the straight segment 3022, the variable diameter segment 3021 is a tapered rod structure with a gradually decreasing radius from the direction away from the tip portion 204 to the direction close to the tip portion 204. The design of the first inner lining rod segment 301 can greatly improve the mechanical feedback performance and torque transmission performance of the single lumen tube 2 close to the tip portion 204; the design of the variable diameter segment 3021 and the straight segment 3022 can improve the resilience performance of the single lumen tube 2 close to the tip portion 204, and the gradually tapered straight rod structure can effectively ensure the flexibility and bending performance of the single lumen tube 2 close to the tip portion 204, so that the single lumen tube 2 close to the tip portion 204 can quickly rebound and reset after deformation in the narrow and protruding obstacle in the curved cavity of the human body, quickly adapt to the shape change of the cavity of the human body and the protruding obstacle, greatly improving the tracking performance and passing performance of the single lumen tube 2 close to the tip portion 204 along the anatomical structure of the cavity in the complex curved cavity of the human body.

[0066] Further, the inner lining rod 3 can be made of an alloy material with excellent resilience performance. Among them, the preferred material is nickel alloy, titanium alloy or mixed metal material containing nickel and titanium.

[0067] In an optional embodiment of the present application, as shown in Figure 1 、 Figure 3 、 Figure 4 As shown in the figure, the straight segment 3022 is provided with a developing wire 303, which has excellent developing performance under X-ray. During the clinical delivery operation, the mechanical properties of the single lumen tube 2 close to the tip portion 204 can be adjusted by pulling back or pushing forward the inner lining rod 3 in the relative position of the single lumen tube 2 away from the tip portion 204 according to the mechanical feedback of the single lumen tube 2 close to the tip portion 204, so as to ensure that the single lumen tube 2 close to the tip portion 204 maintains excellent tracking performance and passing performance. The developing wire 303 plays an important role in the position adjustment process of the inner lining rod 3, and the position of the inner lining rod 3 can be accurately confirmed through the developing wire 303, thereby improving the success rate of clinical operation.

[0068] Further, as shown in Figure 4As shown, the developing wire 303 is wound on the straight section 3022 in a single helix structure or a multi-helix structure, and is fixed to the inner liner rod 3 by welding or bonding or the like. The single helix structure of the developing wire 303 can maximize the flexibility and bending performance of the developing wire 303. Meanwhile, the winding and fixing of the developing wire 303 on the straight section 3022 of the inner liner rod 3 can maximize the mechanical transition of the variable diameter section 3021 of the inner liner rod 3, maximize the flexibility and resilience of the straight section 3022 of the inner liner rod 3, and maximize the flexibility and resilience of the distal section of the single lumen tube 2 according to the lesion morphology of the human body cavity.

[0069] In an optional embodiment of the present application, as shown in Figure 1 The single lumen balloon catheter comprises a handle 4 connected to the single lumen tube 2 and away from one end of the tip portion 204, and the first port 401 and the second port 402 are both located on the handle 4.

[0070] Further, as shown in Figure 1 The first port 401, the single lumen tube 2 and the inner liner rod 3 are coaxially arranged, which not only facilitates the regulation of the inner liner rod 3, but also maximizes the mechanical feedback of the single lumen tube 2 from the tip portion 204 to the distal end of the tip portion 204 to the inner liner rod 3, and maximizes the torque transmission capacity of the single lumen tube from the distal end of the tip portion 204 to the tip portion 204.

[0071] Further, as shown in Figure 1 The angle between the central axis of the first port 401 and the central axis of the second port 402 is 10° to 90°, so that the handle 4 is in the shape of "Y".

[0072] In an optional embodiment of the present application, as shown in Figure 1 The first port 401 is provided with an inner liner rod base 304 capable of sealing and plugging the first port 401, and the inner liner rod 3 and away from the tip portion 204 is connected to the inner liner rod base 304. During clinical operation, after the balloon catheter is delivered to the lesion site, the inner liner rod 3 is pushed forward to the tip portion 204 of the single lumen tube 2, and then the inner liner rod base 304 is sealed and fixed with the first port 401 on the handle 4 by rotating, and after sealing and fixing, liquid is injected into the cavity 205 through the second port 402. The connection position of the inner liner rod base 304 and the handle 4 can withstand a pressure greater than or equal to 3 atm without leakage during the water injection process. The pushing of the inner liner rod 3 to the position close to the tip portion 204 of the single lumen tube 2 can ensure that the balloon 1 has sufficient mechanical support during the inflation and expansion process, and can effectively prevent the balloon 1 from shifting during the inflation and expansion process.

[0073] The single lumen balloon catheter of the present application has the following characteristics and advantages:

[0074] I. The single-lumen balloon catheter is simple and convenient to operate, can be used with the endoscope instruments commonly used in clinical practice, can be delivered to the lesion site of the patient through the instrument channel, reduces the damage to the mucosa of the human body cavity caused by the direct delivery of the balloon catheter through the human body cavity, and improves the accuracy of the delivery and positioning of the balloon catheter under the direct vision of the endoscope.

[0075] II. In the single-lumen balloon catheter, the coaxial tapered inner lining rod 3 can adjust its position in the single-lumen tube 2, thereby improving the control performance, tracking performance and passing performance of the balloon catheter, and the relative position of the inner lining rod in the distal region of the single-lumen tube 2 can be flexibly adjusted during the surgical procedure according to the actual environment of the human body cavity, the mechanical properties of the distal region of the single-lumen tube 2 can be flexibly adjusted, and the success rate of clinical operation is greatly improved.

[0076] III. In the single-lumen balloon catheter, the inner lining rod 3 is provided with a developing wire 303, which ensures the accuracy of the pullback and pushforward adjustment of the inner lining rod 3 during the delivery of the balloon 1, and maximizes the flexibility and resilience of the distal region of the single-lumen tube 2.

[0077] The above description is only a specific embodiment of the present application, and is not intended to limit the scope of the present application. Any equivalent changes and modifications made by those skilled in the art without departing from the concept and principles of the present application shall fall within the scope of the present application.

Claims

1. A single-lumen balloon catheter, characterized by, The single-lumen balloon catheter comprises a single-lumen tube and a lining rod, the single-lumen tube is internally formed with a lumen along its axial direction, a balloon is arranged on the single-lumen tube and communicates with the lumen, the lining rod is movably arranged in the lumen along the axial direction of the single-lumen tube, one end of the single-lumen tube is provided with a first port for controlling the position of the lining rod and a second port for injecting liquid into the lumen to inflate the balloon, and the other end of the single-lumen tube is formed with a tip portion; The lining rod is pushed inward to move in the lumen to a position close to the tip portion; The lining rod is pulled outward to move in the lumen to a position away from the tip portion in the direction of the first port; The lining rod comprises a first lining rod segment away from the tip portion and a second lining rod segment close to the tip portion, the first lining rod segment is a straight rod structure extending along the axial direction of the single-lumen tube to improve the mechanical feedback performance and torque transmission performance of the single-lumen tube at the position close to the tip portion; The second lining rod segment comprises a variable-diameter segment and a straight segment, one end of the variable-diameter segment is connected with the first lining rod segment, the other end of the variable-diameter segment is connected with the straight segment to improve the resilience performance of the single-lumen tube at the position close to the tip portion; The variable-diameter segment is a conical rod structure with a gradually decreasing radius from the direction away from the tip portion to the direction close to the tip portion to ensure the flexibility and bending performance of the single-lumen tube at the position close to the tip portion; A developing wire in a spiral shape is wound on the straight segment, and the developing wire is fixed to the lining rod in an integrated manner by welding or bonding.

2. The single-lumen balloon catheter of claim 1, wherein, The balloon is arranged on the single-lumen tube and at a position close to the tip portion, the inside of the balloon communicates with the lumen, and liquid is injected into the lumen to inflate the balloon.

3. The single-lumen balloon catheter of claim 2, wherein, The single-lumen tube passes through the balloon, and at least one liquid inlet hole is formed on the single-lumen tube to communicate the lumen with the inside of the balloon, so that the liquid injected into the lumen enters the inside of the balloon.

4. The single-lumen balloon catheter of claim 2, wherein, The balloon comprises an inflation segment and first and second end portions located on both sides of the inflation segment along the axial direction of the single-lumen tube, the balloon is connected with the single-lumen tube through the first and second end portions, and when liquid is injected into the balloon, only the inflation segment is in an inflated and expanded state among the inflation segment, the first end portion and the second end portion.

5. The single-lumen balloon catheter of claim 4, wherein, The surface of the inflation segment or part of the surface of the inflation segment is coated with a drug layer.

6. The single-lumen balloon catheter of claim 1, wherein, The single-lumen tube comprises a first single-lumen tube segment, a second single-lumen tube segment and a third single-lumen tube segment along its axial direction in sequence, the first port and the second port are both located at one end of the first single-lumen tube segment, the other end of the first single-lumen tube segment is connected with one end of the second single-lumen tube segment, the other end of the second single-lumen tube segment is connected with one end of the third single-lumen tube segment, the tip portion is located at the other end of the third single-lumen tube segment, and the hardness of the first single-lumen tube segment and the hardness of the second single-lumen tube segment are greater than the hardness of the third single-lumen tube segment; The balloon is located on the second single-lumen tube segment and away from one side of the first single-lumen tube segment.

7. The single-lumen balloon catheter of claim 6, wherein, The third single-lumen tube section has an axial length of 3-50 mm along the single-lumen tube.

8. The single-lumen balloon catheter of claim 7, wherein, The third single-lumen tube section has an axial length of 15-50 mm along the single-lumen tube.

9. The single-lumen balloon catheter of claims 1 or 6, wherein, The tip portion has a closed circular arc structure.

10. The single-lumen balloon catheter of claim 1, wherein, The single-lumen balloon catheter comprises a handle connected to one end of the single-lumen tube away from the tip portion, and the first port and the second port are both located on the handle, and the first port, the single-lumen tube and the inner liner rod are coaxially arranged.

11. The single-lumen balloon catheter of claim 10, wherein, The first port is provided with an inner liner rod base capable of sealing the first port, and one end of the inner liner rod away from the tip portion is connected to the inner liner rod base. The first port is provided with an inner liner rod base capable of sealing the first port, and one end of the inner liner rod away from the tip portion is connected to the inner liner rod base.

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