Balloon catheter and balloon catheter assembly

Abstract

The application discloses a balloon catheter and a balloon catheter assembly, and belongs to the balloon catheter field. The balloon catheter comprises a catheter, a connecting pipe and a working pipe. The working pipe is arranged through the catheter. The catheter is provided with a balloon. A plurality of protruding pieces are uniformly arranged around the outer periphery of the balloon. The bottom end of the catheter is provided with a channel pipe. The extending ends of the connecting pipe are respectively communicated with the corresponding protruding pieces. The circumferential end of the connecting pipe is communicated with the channel pipe. The anchor function is built in the guide catheter itself, and the complicated steps of additionally conveying a guide wire and a balloon catheter into a branch blood vessel for anchoring are omitted. The operator only needs to operate a single instrument to establish stable support, the operation time is significantly shortened, and the exposure time of the operator and the patient under X-rays is reduced. After anchoring, the operator can immediately perform subsequent operations through the central working lumen, realizes seamless connection from establishing support to passing through the lesion, and greatly improves the operation fluency.

Description

Technical Field

[0001] This invention relates to the field of balloon catheter technology, and more specifically, to a balloon catheter and a balloon catheter assembly. Background Technology

[0002] Balloon anchoring is a commonly used advanced strategy to address insufficient support force in guiding catheters. Its core principle is to use balloon expansion within branch vessels to generate anchoring force.

[0003] This technique typically requires a separate anchoring balloon catheter. During the procedure, a guidewire is first inserted into a branch vessel proximal to the target lesion, and then a separate balloon catheter is advanced along the guidewire into that branch. Next, the balloon is inflated at low pressure (e.g., 6-8 atmospheres) outside the guiding catheter, ensuring close contact with the branch vessel wall. In this way, the balloon catheter and the guiding catheter work together, providing the guiding catheter with a relatively stable fulcrum, thereby enhancing its overall support and facilitating the passage of subsequent instruments through the target lesion.

[0004] While balloon anchoring technology improves support to some extent, it has the following inherent drawbacks, which are precisely what this invention aims to address:

[0005] The procedure is complex and carries a risk of vascular injury: This technique requires the introduction of an additional guidewire and balloon catheter into the branch vessel, increasing the number of instrumentation steps and the operation time. Inflation of the balloon within a healthy branch vessel may damage the intima, posing a risk of branch vessel tearing. Although lower pressure dilation is recommended, the risk still exists.

[0006] The fundamental coaxiality problem remains unresolved: balloon anchoring technology primarily provides radial gripping force in branch vessels. However, this anchoring method cannot guarantee axial coaxiality between the guiding catheter and the target main vessel. When the guiding catheter is not coaxial with the main vessel, the force direction of subsequent instruments (such as guidewires and balloons) will shift as they advance. This not only leads to low operational efficiency but also increases the risk of the guidewire tip piercing or damaging the main vessel wall due to difficulty in accurately aligning with the true lumen of the vessel, potentially causing serious complications such as vascular rupture and dissection. Furthermore, the support force is significantly attenuated during transmission due to angular deviations.

[0007] Potential impact on non-target vessels: This technique occupies and dilates a healthy branch vessel, potentially affecting the original blood flow in that branch. While this is acceptable in most cases, it undoubtedly increases the intervention and potential risks to vessels outside the therapeutic target area. Current techniques are not suitable for completely occlusive pulmonary vascular lesions. Pulmonary intervention differs from coronary intervention, and current pulmonary interventional treatments (especially for occlusive lesions) often draw on coronary techniques. However, pulmonary vessels have unique anatomical characteristics, such as a larger lumen diameter than coronary arteries, thinner pulmonary artery walls, greater difficulty in bifurcation, and a higher risk of guidewire perforation. Furthermore, there are currently no suitable guiding catheters available on the market; and balloon anchoring techniques are not suitable for completely occlusive lesions.

[0008] In summary, while existing balloon anchoring techniques offer a way to enhance support, their operational complexity, risk of vascular injury, and inability to resolve coaxiality issues limit their optimal clinical application. These shortcomings are particularly pronounced when treating lesions such as the pulmonary artery, which have significant differences in the lumen and require extremely high levels of support and coaxiality. Summary of the Invention

[0009] In view of the problems existing in the prior art, the purpose of the present invention is to provide a balloon catheter and a balloon catheter assembly.

[0010] To solve the above problems, the present invention adopts the following technical solution.

[0011] A balloon catheter includes a catheter, a connecting tube, and a working tube. The working tube extends through the catheter. A balloon assembly is provided outside the catheter. The balloon assembly includes a balloon. A plurality of protrusions are evenly arranged around the outer periphery of the balloon. The protrusions are arranged along the length direction of the balloon. A channel tube is provided at the bottom end of the catheter. The channel tube is arranged along the length direction of the catheter. Several extension ends of the connecting tube are respectively connected to several corresponding protrusions. The circumferential end of the connecting tube is connected to the channel tube.

[0012] Optionally, the wall of the catheter consists of a polymer outer layer, a metal braided mesh reinforcement layer, and a PTFE inner liner layer, from the outside to the inside.

[0013] Optionally, the outer polymer layer is polyurethane or block polyetheramide resin.

[0014] Optionally, the protrusion is a hollow columnar structure.

[0015] Optionally, the balloon expands to form a first cavity, which is a hollow barrel-shaped structure.

[0016] Optionally, the circumferential end is an annular tube, and several arc-shaped extension ends are uniformly arrayed around the annular tube. The curvature of the extension ends is adapted to the curvature of the outer surface of the balloon. The annular tube is sleeved on the catheter, and the multiple extension ends are interconnected through the annular tube.

[0017] Optionally, the channel tube is connected to the annular tube or to any of the extension ends.

[0018] A balloon catheter assembly includes the balloon catheter and a multi-port tube disposed at the end of the catheter away from the balloon. The main tube of the multi-port tube is connected to the catheter, and the side tubes on both sides of the multi-port tube are connected to the balloon and the channel tube, respectively.

[0019] Optionally, a side tube with a second opening at one end is connected to a channel tube, and a side tube with a first opening at one end is connected to a balloon.

[0020] Compared with the prior art, the technical solution provided by this invention has at least the following beneficial effects:

[0021] In the above approach, the anchoring function is integrated into the guiding catheter itself, eliminating the cumbersome step of separately delivering a guidewire and balloon catheter into the branch vessel for anchoring. The surgeon only needs to operate a single instrument to establish stable support, significantly shortening the operation time and reducing the exposure time of both the surgeon and the patient under X-rays. Seamless workflow: After anchoring, the surgeon can immediately perform subsequent operations through the central working channel, achieving a seamless transition from "establishing support" to "passing through the lesion," greatly improving the smoothness of the procedure.

[0022] Eliminating the risk of branch vessel injury: By completely avoiding the dilation and instrument manipulation of healthy branch vessels, the risk of branch vessel intimal damage, spasm, or tearing, which may occur with existing balloon anchoring techniques, is fundamentally eliminated. Optional blood flow channels enhance the safety window: The preferred blood flow channel design of this invention allows for the maintenance of partial blood flow during balloon anchoring, effectively preventing ischemia in downstream tissues of the target vessel, giving physicians more ample and safer operation time when dealing with complex lesions. Guidewire injury during interventional procedures often occurs because the guidewire travels along the vessel wall, especially the sidewall of diseased vessels. This invention, by placing the anchoring balloon outside the guiding catheter, ensures that the working channel is centered on the target vessel, perfectly avoiding the possibility of guidewire injury.

[0023] The catheter tip of this invention automatically tunes to the central axis of the blood vessel due to the anchoring of the balloon, forming a highly coaxial relationship. Attached Figure Description

[0024] The accompanying drawings, which are incorporated herein and form part of the specification, illustrate embodiments of the invention and, together with the specification, further serve to explain the principles of the invention and enable those skilled in the art to practice and use the invention.

[0025] Figure 1 This is a schematic diagram of the structure of the present invention;

[0026] Figure 2 For the present invention Figure 1 Cross-sectional view at point AA;

[0027] Figure 3 For the present invention Figure 1 Cross-sectional view at point BB;

[0028] Figure 4 For the present invention Figure 1 Cross-sectional view at point CC;

[0029] Figure 5 This is a front view of the connecting tube of the present invention;

[0030] Figure 6 This is a structural diagram of the catheter of the present invention;

[0031] Figure 7 For the present invention Figure 1 A partial structural diagram.

[0032] [Figure Labels]

[0033] 1. Catheter; 2. Balloon; 3. First cavity; 41. Protrusion; 42. Channel tube; 43. Connecting tube; 5. Working tube; 6. Multi-port tube; 7. First port; 8. Second port; 9. Polymer outer layer; 10. Metal braided mesh reinforcement layer; 11. PTFE inner liner.

[0034] As shown in the figure, specific structures and devices are marked in the figure to clearly illustrate the structure of the embodiments of the present invention. However, this is only for illustrative purposes and is not intended to limit the present invention to this specific structure, device and environment. Those skilled in the art can adjust or modify these devices and environments according to specific needs. Detailed Implementation

[0035] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. It should also be noted that, to make the embodiments more comprehensive, the following embodiments are the best and preferred embodiments, and those skilled in the art can use other alternative methods to implement some well-known technologies; moreover, the accompanying drawings are only for more specific description of the embodiments and are not intended to specifically limit the present invention.

[0036] It should be noted that the use of terms such as "an embodiment," "an embodiment," "an exemplary embodiment," and "some embodiments" in the specification indicates that the described embodiment may include a specific feature, structure, or characteristic, but not every embodiment necessarily includes that specific feature, structure, or characteristic. Furthermore, when describing a specific feature, structure, or characteristic in conjunction with embodiments, implementing such a feature, structure, or characteristic in conjunction with other embodiments should be within the knowledge of those skilled in the art.

[0037] Generally, terms can be understood at least partly from their use in context. For example, depending at least partly on the context, the term "one or more" as used herein can be used to describe any feature, structure, or characteristic in a singular sense, or a combination of features, structures, or characteristics in a plural sense. Additionally, the term "based on" can be understood not necessarily to convey an exclusive set of factors, but rather, alternatively, depending at least partly on the context, to allow for the presence of other factors that are not necessarily explicitly described.

[0038] It is understood that the meanings of “on”, “above”, and “above” in this invention should be interpreted in the broadest manner, such that “on” means not only “directly on” something, but also includes the meaning of being “on” something with an intervening feature or layer, and that “above” or “above” means not only “on” something, but also includes the meaning of being “on” something without an intervening feature or layer.

[0039] Furthermore, spatially related terms such as “below,” “under,” “lower,” “above,” and “upper” are used herein for convenience to describe the relationship of one element or feature to one or more other elements or features, as illustrated in the accompanying drawings. Spatially related terms are intended to cover different orientations in the use or operation of the device other than those depicted in the accompanying drawings. The device may be oriented in other ways, and the spatially related descriptive terms used herein can be interpreted similarly.

[0040] Example 1

[0041] like Figure 6As shown, this embodiment of the invention provides a catheter 1, which consists of a polymer outer layer 9, a metal braided mesh reinforcement layer 10, and a PTFE inner liner layer 11, from the outside to the inside. The polymer outer layer 9 is polyurethane or block polyetheramide resin. The catheter 1 has sufficient pushability and torque transmission capability. The wall structure of the catheter 1 is typically a multi-layer composite structure, for example, from the outside to the inside, consisting of a polymer outer layer 9 such as polyurethane or PEBAX, a metal braided mesh reinforcement layer 10 or a stainless steel coil reinforcement layer, and a PTFE inner liner layer 11. The polymer outer layer 9 provides biocompatibility and flexibility; the metal braided mesh reinforcement layer 10 imparts the necessary flexural strength and torsional stiffness to the catheter, ensuring that the support force can be effectively transmitted from the proximal end to the distal end; the PTFE inner liner layer 11 reduces the frictional resistance in the central working channel, facilitating instrument passage.

[0042] Example 2

[0043] like Figures 1-5 ,as well as Figure 7 As shown, based on Embodiment 1, this embodiment of the invention provides a balloon catheter, including a catheter 1 and a working tube 5. The working tube 5 is disposed through the catheter 1. It also includes a balloon 2, which is sleeved on the outside of the catheter 1. A plurality of protrusions 41 are uniformly arranged in a ring array on the outer periphery of the balloon 2. Each protrusion 41 extends along the length direction of the balloon 2. A channel tube 42 is disposed below the catheter 1 and is arranged along the length direction of the catheter 1. A circumferential end of a connecting tube 43 is disposed on the outer circumference of one end of the balloon 2. The connecting tube 43 includes a plurality of extension ends arranged in a uniform ring array. The extension ends are connected to the circumferential end. The extension end of each connecting tube 43 is connected to the corresponding protrusion 41. The circumferential end of the connecting tube 43 is connected to the channel tube 42.

[0044] The balloon 2 can be made of non-compliant (e.g., PET, for providing precise, shape-fixed anchoring), semi-compliant (e.g., nylon, to balance anchoring force with vascular adaptability), or compliant (e.g., silicone, for irregular vessels) materials as needed.

[0045] The working pressure range of the balloon 2 is typically designed to be 2-10 atmospheres.

[0046] When it expands, it achieves direct anchoring by generating a uniform radial frictional force with the vessel wall of the target blood vessel trunk. This design avoids the use of branch vessels, thereby eliminating the risk of damage to branch vessels.

[0047] The integrated design of "catheter 1 - balloon assembly - protrusion 41 - channel tube 42 - connecting tube 43" achieves the integrated function of "guidance and anchoring". The core principle is as follows:

[0048] The balloon 2 of the balloon assembly is inflated / contracted by the balloon ventilation tube. When inflated, the balloon 2 adheres to the branch vessel wall, providing basic anchoring force for the catheter 1.

[0049] The channel tube 42 extends along the length of the catheter 1 and serves as a "medium delivery channel" such as saline or contrast agent. The medium is delivered to multiple protrusions 41 through the connecting tube 43.

[0050] The protrusions 41 are evenly distributed around the balloon 2. After receiving the medium, the protrusions 41 assist in supporting the balloon 2, preventing the balloon 2 from collapsing locally, and at the same time enhancing the tightness of the balloon 2 in contact with the blood vessel wall, forming a dual anchoring mechanism of "basic anchoring of the balloon and auxiliary positioning of the protrusions".

[0051] This embodiment simplifies the surgical procedure, eliminating the need for an additional independent anchoring balloon catheter. The "interventional device guidance and delivery" and "anchoring support" can be achieved simultaneously through this catheter 1, reducing the steps of guidewire insertion and balloon catheter push by one, and shortening the operation time.

[0052] This embodiment can reduce the risk of vascular injury, reduce the repeated pushing and pushing of instruments in blood vessels, and avoid problems such as vascular intima scratches and branch vessel blockage caused by friction from multiple instruments.

[0053] This embodiment can improve anchoring stability. The dual anchoring mechanism can adapt to scenarios with vascular calcification and tricky branch angles, avoiding anchoring displacement caused by uneven vascular walls of a single balloon.

[0054] The protrusion 41 is a hollow columnar structure, arranged in a ring at equal intervals around the conduit 1. The contact surfaces between the protrusion 41 and the balloon 2 are tightly fitted. The hollow columnar design of the protrusion 41 is primarily to meet the dual requirements of media transfer and structural support: after being connected to the connecting tube 43, the hollow structure of the protrusion 41 can serve as a temporary storage and diffusion channel for the media, preventing local accumulation of the media within the balloon 2; at the same time, the hollow cavity can buffer the pressure during the expansion of the balloon 2, preventing the protrusion 41 from rupturing under stress.

[0055] The columnar structure of the protrusion 41 allows its length-to-diameter ratio to match the arc-shaped outer surface of the balloon 2, enabling it to be stably arranged along the length of the balloon 2. The columnar sidewalls tightly adhere to the balloon 2, forming linear support and preventing localized pressure on the balloon 2 walls. After inflation, the balloon 2 forms a first cavity 3, which is a hollow, barrel-shaped structure.

[0056] The contact surface between one side of the channel tube 42 and the body of the catheter 1 is tightly fitted. The connecting tube 43 includes a circumferential end in the form of an annular tube and multiple extension ends in arc-shaped tubes adapted to the curvature of the outer surface of the balloon 2. One end of the arc-shaped tube is connected to the annular tube, and the other end of the arc-shaped tube is connected to the protrusion 41. The annular tube is fixedly sleeved on the catheter 1, and the multiple arc-shaped tubes are interconnected through the annular tube. The channel tube 42 is connected to the annular tube or to any one of the arc-shaped tubes.

[0057] To further enhance surgical safety, especially in procedures where the anchoring time may be long, the present invention provides a preferred embodiment: at least one axially extending blood flow channel is provided on the surface of the anchoring balloon. This channel can be the gap formed by the balloon and the protrusion 41, which allows blood to flow and is referred to as the blood flow channel.

[0058] When the balloon inflates and anchors within the blood vessel, this blood flow channel allows a portion of the blood to flow from the proximal end of the balloon to the distal end, significantly reducing the impact on downstream tissue perfusion and extending the safe operating window of the invention, making it applicable to a wider range of clinical scenarios.

[0059] The central working lumen runs the entire length of the catheter, with its outlet located at the distal end of the anchoring balloon. The portion of the central working lumen that passes through the anchoring balloon 2 is either constructed as an independent tubular channel or supported by a rigid inner liner. This ensures that when the anchoring balloon 2 is inflated, the central working lumen remains patent and retains its original inner diameter, preventing collapse or narrowing due to balloon compression. This guarantees unobstructed and low-resistance passage for all subsequent interventional instruments, crucial for achieving efficient surgery.

[0060] Example 3

[0061] like Figure 1 and Figure 7 As shown, based on Embodiments 2 and 1, a balloon catheter assembly includes a balloon catheter and a multi-port tube 6. The multi-port tube 6 is disposed at the end of the catheter 1 away from the balloon 2. The main tube of the multi-port tube 6 is connected to the catheter 1, and the side tubes on both sides of the multi-port tube 6 are connected to the balloon 2 and the channel tube 42, respectively. The ends of the two side tubes are connected to a first port 7 and a second port 8, respectively. The side tube with the second port 8 is connected to the channel tube 42. The side tube with the first port 7 is connected to the balloon 2.

[0062] The workflow of the technical solution of this invention is as follows:

[0063] The operator advances the catheter 1 to the predetermined position in the target blood vessel (such as the pulmonary artery), allowing the anchoring balloon 2 to span the desired segment of the vessel. A pressurizing medium (such as a mixture of saline and contrast agent) is injected into the anchoring balloon 2 through the first port 7 via the pressurized channel formed between the balloon 2 and the catheter 1. The balloon 2 inflates and adheres tightly to the vessel wall, thereby actively and securely anchoring the entire catheter 1 system within the target blood vessel trunk.

[0064] Continue injecting pressurized medium (such as a mixture of saline and contrast agent) into the protrusion 41 through the channel tube 42 from the second port 8. The protrusion 41 expands and adheres to the blood vessel wall, thereby forming a gap between the balloon, the protrusion 41 and the blood vessel wall. This gap allows blood to flow and is called a blood flow channel.

[0065] At this point, the tip of catheter 1 automatically tunes to the central axis of the blood vessel due to the anchoring of balloon 2, achieving a highly coaxial relationship. Subsequently, the operator can then advance guidewires, balloon catheters, stents, or extension catheters through the patent central working channel, specifically the channel extending from tip to end within catheter 1. Balloon 2 provides extremely strong proximal support and ensures the instruments advance along the true lumen of the blood vessel.

[0066] This invention encompasses any substitutions, modifications, equivalent methods, and solutions made within the spirit and scope of this invention. To provide the public with a thorough understanding of this invention, specific details are described in detail in the following preferred embodiments; however, those skilled in the art will fully understand the invention even without these details. Furthermore, to avoid unnecessary misunderstanding of the essence of this invention, well-known methods, processes, procedures, components, and circuits are not described in detail.

[0067] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A balloon catheter, characterized in that, The device includes a catheter, a connecting tube, and a working tube. The working tube extends through the catheter. A balloon assembly is fitted over the catheter, and the balloon assembly includes a balloon. Multiple protrusions are evenly arranged around the outer periphery of the balloon, and the protrusions are arranged along the length of the balloon. A channel tube is provided at the bottom end of the catheter, and the channel tube is arranged along the length of the catheter. Several extension ends of the connecting tube are respectively connected to several corresponding protrusions, and the circumferential end of the connecting tube is connected to the channel tube. It also includes a multi-port tube, which is disposed at the end of the catheter away from the balloon. The main tube of the multi-port tube is connected to the catheter, and the side tubes on both sides of the multi-port tube are connected to the balloon and the channel tube, respectively. The circumferential end is an annular tube, and several arc-shaped extension ends are uniformly arrayed around the annular tube. The curvature of the extension ends is adapted to the curvature of the outer surface of the balloon. The annular tube is sleeved on the catheter, and the multiple extension ends are interconnected through the annular tube. The channel tube is connected to the annular tube or to any one of the extension ends. The ends of the two side tubes are connected to the first port and the second port, respectively. The side tube with the second port at its end is connected to the channel tube, and the side tube with the first port at its end is connected to the balloon. At least one axially extending blood flow channel is provided on the surface of the anchoring balloon, which is the gap formed between the balloon and the protrusion. The operator can then insert subsequent interventional devices such as guidewires, balloon catheters, stents, or extension catheters by maintaining a patent central working channel, which is specifically a channel running from head to tail within the catheter.

2. The balloon catheter according to claim 1, characterized in that, The wall of the catheter consists of a polymer outer layer, a metal braided mesh reinforcement layer, and a PTFE inner liner layer, from the outside to the inside.

3. The balloon catheter according to claim 2, characterized in that, The outer polymer layer is polyurethane or block polyetheramide resin.

4. The balloon catheter according to claim 1, characterized in that, The protrusion is a hollow columnar structure.

5. A balloon catheter according to claim 1, characterized in that, After the balloon expands, it forms a first cavity, which is a hollow barrel-shaped structure.

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