Balloon catheter suitable for long vasculopathy
By designing a first balloon with a proximal diameter greater than the distal diameter and a second balloon with better compliance, combined with a sliding ring and a sealed connection membrane, the problem of poor fitting effect of existing balloon catheters in treating longer vascular lesions is solved, achieving better vascular adaptability and surgical results.
Patent Information
- Application Number
- CN202411828773.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-12
- Publication Date
- 2025-03-11
- Estimated Expiration
- 2044-12-12
AI Technical Summary
When treating long vascular lesions, existing balloon catheters are difficult to adapt to changes in blood vessel diameter, resulting in poor fit between the balloon and blood vessels, which can easily cause damage to the blood vessels or re-stenosis.
A balloon catheter is designed, including a first balloon and a second balloon. The proximal diameter of the first balloon is greater than the distal diameter. By providing a sliding ring and a sealing connection membrane, the compliance and stability of the second balloon are improved to adapt to changes in blood vessel diameter.
By setting the first balloon and the second balloon, it can better adapt to the shape changes of the blood vessels, improve the fitting effect between the balloon and the blood vessels, reduce the risk of blood vessel damage and re-stenosis, and improve the surgical effect.
Smart Images

Figure CN119587848A_ABST
Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of medical devices, and in particular relates to a balloon catheter suitable for treating long vascular lesions. Background Art
[0002] Balloon catheters are widely used in vascular dilatation and angioplasty surgeries, and are mainly composed of two parts: a balloon and a catheter. The balloon is located at the distal end of the catheter. Generally speaking, after the balloon catheter is processed and assembled, the balloon is attached to the outer surface of the catheter. When a certain pressure of liquid or gas is injected from the proximal end of the balloon catheter, the injected liquid or gas will flow into the balloon, causing the balloon to expand. If the injection pressure is released, the balloon returns to its original state.
[0003] Combined with the physical expansion effect of the balloon, drugs can also be sprayed on the surface of the balloon and released to the blood vessel wall in contact with it when the balloon expands, thereby further treating vascular stenosis.
[0004] The balloon of an existing balloon catheter is usually a uniform overall structure, and the balloon diameter does not change. When used in dilation surgery to treat stenotic blood vessels, the balloon is evenly filled under the pressure of injected liquid or gas. For blood vessels with longer lesions, the diameter of the proximal and distal ends of the blood vessels is significantly different. Although ordinary balloons can dilate blood vessels to a certain extent to achieve the purpose of treating stenotic lesions, it is very easy for the proximal end to expand to the required size and the distal end to expand excessively, causing damage to the distal blood vessel. Or the distal end expands to the required size, but the proximal end does not expand sufficiently, which can easily cause the blood vessel to narrow again or even stenosis. In general, ordinary balloons are difficult to adapt to changes in blood vessel diameter, resulting in poor adhesion between the balloon and the blood vessel.
[0005] Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art. Summary of the invention
[0006] The purpose of the present invention is to provide a balloon catheter suitable for longer vascular lesions. By setting the first balloon to have a proximal diameter larger than a distal diameter, the problem of the proximal end expanding to a desired size after the balloon is inflated and the distal end over-expanding, causing damage to the distal blood vessel, and the distal end expanding to a desired size but the proximal end not expanding sufficiently, which easily causes the blood vessel to narrow again or even stenosis, is solved.
[0007] In order to achieve the above object, the present invention provides the following technical solutions:
[0008] A balloon catheter suitable for treating long vascular lesions, comprising a catheter body;
[0009] A first balloon, disposed at the distal end of the catheter body;
[0010] Wherein, the proximal diameter of the first balloon is greater than the distal diameter;
[0011] A penetrating inner cavity is arranged in the middle of the catheter body, and a connecting channel connecting the first balloon and the inner cavity is opened on the side wall of the catheter body.
[0012] Preferably, the catheter body is provided with a second balloon covering the first balloon, the proximal end of the second balloon is connected to a sliding ring, the sliding ring is provided with an infusion channel extending therethrough, the proximal end of the sliding ring is connected to an infusion tube, the proximal end of the first balloon is provided with a sealing connecting membrane, and the proximal end of the sealing connecting membrane is connected to the sliding ring.
[0013] Preferably, the sealing connection membrane is annular and does not allow liquid or gas to pass through.
[0014] Preferably, the distance between the second balloon sidewall and the first balloon sidewall gradually increases from the distal end to the proximal end.
[0015] Preferably, a sliding layer is provided on the inner annular surface of the sliding ring in contact with the side wall of the catheter body.
[0016] Preferably, the first balloon is a non-compliant balloon, and the second balloon is a compliant balloon.
[0017] Preferably, the proximal Luer of the catheter body is connected to a Y-type valve, the infusion tube passes through a fork of the Y-type valve, and the main channel of the Y-type valve is connected to the inner cavity.
[0018] Preferably, the wall thicknesses of the first balloon and the second balloon are uniformly set.
[0019] Preferably, a developing ring is provided at the distal end of the catheter body.
[0020] Preferably, the first balloon is made of the same material as a whole, and the first balloon is nylon (polyamide) or PET.
[0021] Beneficial effects:
[0022] (1) The present invention provides a first balloon and a second balloon. After the first balloon is inflated, it squeezes the second balloon, so that the contrast agent in the second balloon is gradually squeezed out, and the second balloon is deformed. The deformed second balloon fits better at the narrow part of the blood vessel and can better adapt to the change of the inner diameter of the channel at the longer blood vessel.
[0023] (2) The present invention improves the compliance of the second balloon by providing a sliding ring, avoids excessive squeezing of the inner wall of the blood vessel, and uses the second balloon to fill between the first balloon and the stenosis, so that the balloon and the stenosis fit better, can better adapt to the diameter change of the long blood vessel, and improve the surgical effect;
[0024] (3) The present invention provides a sealing connection membrane which is elastic and can expand or contract with the sliding of the sliding ring, thereby improving stability and preventing the liquid entering the second balloon from leaking. BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. Among them:
[0026] Figure 1 It is a schematic diagram of the structure of a balloon catheter in an embodiment of the present invention;
[0027] Figure 2 This is a schematic diagram of the structure of a balloon catheter located at a stenotic site in an embodiment of the present invention;
[0028] Figure 3 is a schematic diagram of the overall structure of the balloon catheter in another embodiment of the present invention in a contracted state;
[0029] Figure 4 is a schematic diagram of the overall structure of the balloon catheter in another embodiment of the present invention in an expanded state;
[0030] Figure 5 It is a schematic cross-sectional view of the overall structure of the balloon catheter in another embodiment of the present invention in an expanded state;
[0031] Figure 6 for Figure 5 A magnified view of the structure at A;
[0032] Figure 7 is a schematic diagram of a balloon catheter in a contracted state and located at a stenotic site of a blood vessel in another embodiment of the present invention;
[0033] Figure 8 This is a schematic diagram of a balloon catheter in an expanded state and located at a stenotic site of a blood vessel in another embodiment of the present invention.
[0034] In the figure: 1. catheter body; 11. inner cavity; 12. connecting channel; 2. first balloon; 3. second balloon; 4. sliding ring; 41. infusion channel; 42. sliding layer; 5. infusion tube; 6. sealing connection membrane; 7. Y-type valve; 8. developing ring. DETAILED DESCRIPTION
[0035] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention belong to the scope of protection of the present invention.
[0036] In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., and orientations or positional relationships indicated are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.
[0037] In the description of the present invention, "several" means one or more, "more" means more than two, "greater than", "less than", "exceed" etc. are understood as not including the number itself, and "above", "below", "within" etc. are understood as including the number itself. If there is a description of "first" or "second", it is only used for the purpose of distinguishing the technical features, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.
[0038] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more features.
[0039] In the description of the present invention, it should be noted that, unless otherwise clearly stipulated and limited, the term "connection" should be understood in a broad sense. For example, it can be a fixed connection or a movable connection, a detachable connection or a non-detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or mutual communication; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be internal connection between two elements, indirect connection, or an interactive relationship between two elements.
[0040] In the description of the present invention, the "distal end" refers to the end farther from the doctor during surgery, and the "proximal end" refers to the end closer to the doctor during surgery.
[0041] In the description of the present invention, "before use" refers to a state in which the balloon catheter suitable for longer vascular lesions has not been used, has not entered the human body, or has not come into contact with body fluids such as blood, tissue fluid, etc. in the human body; and "during use" refers to a state in which the balloon catheter suitable for longer vascular lesions has entered the human body or has come into contact with body fluids such as blood, tissue fluid, etc. in the human body.
[0042] In the description of the present invention, the "gathered state" refers to a state in which the "first balloon" and the "second balloon" are attached to each other within a partial length range or within the entire length range.
[0043] In the description of the present invention, "in vivo environment" refers to the environment below the epidermis of the skin where body fluids exist, such as the dermis and subcutaneous tissue, or the inside of blood vessels and organs.
[0044] The present invention will be described in detail below in conjunction with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.
[0045] The balloon of the present invention is generally an integral structure with uniform structure. The balloon is evenly filled under the action of the pressure of the injected liquid or gas. For blood vessels with longer lesions, the diameter difference between the proximal and distal ends of the blood vessels is obvious. Ordinary balloons are prone to the proximal expansion to the required size and the distal over-expansion, causing damage to the distal blood vessels; or the distal end is expanded to the required size, but the proximal end is not fully expanded, which can easily cause the blood vessels to narrow again or even stenosis. Generally speaking, ordinary balloons are difficult to adapt to changes in blood vessel diameter, resulting in poor fitting effect.
[0046] The present invention discloses a balloon catheter suitable for treating long vascular lesions. Figure 1 and Figure 2 , comprising a catheter body 1;
[0047] A first balloon 2, disposed at the distal end of the catheter body 1;
[0048] Wherein, the proximal diameter of the first balloon 2 is greater than the distal diameter;
[0049] A penetrating inner cavity 11 is provided in the middle of the catheter body 1 , and a connecting channel 12 connecting the first balloon 2 and the inner cavity 11 is provided on the side wall of the catheter body 1 .
[0050] The catheter body 1 is made of stainless steel material, which has good biocompatibility in blood vessels and can provide stable support for the first balloon 2. It can also ensure the strength of the catheter body 1, making it less likely to break and ensuring a certain degree of permeability.
[0051] The surface of the catheter body 1 is coated with nylon material, and the outer surface of the nylon material is treated with a hydrophilic coating to improve the passability of the catheter body 1 in the blood vessel.
[0052] The first balloon 2 is welded to the distal end of the catheter body 1. It should be noted that the weld between the first balloon 2 and the catheter body 1 is sealed and will not leak liquid or air. The first balloon 2 can contain contrast medium. After being filled with contrast medium, the first balloon 2 expands under the pressure of the contrast medium, gradually adheres to the inner wall of the blood vessel, and squeezes out the narrow part.
[0053] In other embodiments of the present application, the first balloon 2 may be filled with gas or other liquids (such as saline).
[0054] The diameter of the first balloon 2 gradually increases from the distal end to the proximal end, and the whole is tapered. By setting the proximal diameter of the first balloon 2 to be larger than the distal diameter, the first balloon 2 can adapt to the shape change of the longer blood vessel after expansion, so that the proximal end is closely attached to the proximal end of the blood vessel, and the distal end is closely attached to the distal end of the blood vessel, thereby improving the opening effect of the stenosis.
[0055] When in use, contrast agent is infused from the inner cavity 11 of the catheter body 1. After the contrast agent reaches the first balloon 2, it is infused into the first balloon 2 from the connecting channel 12. The first balloon 2 expands to open the narrow part. Since the blood vessels are long, the diameter of the blood vessels will change. Using this balloon catheter can better adapt to the blood vessels and achieve a better fitting effect, thereby improving the treatment effect.
[0056] Reference Figures 3 to 6 In a preferred embodiment of the present invention, a second balloon 3 covering a first balloon 2 is provided on the catheter body 1, a sliding ring 4 is connected to the proximal end of the second balloon 3, a through-infusion channel 41 is provided on the sliding ring 4, an infusion tube 5 is connected to the proximal end of the sliding ring 4, a sealing connection film 6 is provided at the proximal end of the first balloon 2, and the proximal end of the sealing connection film 6 is connected to the sliding ring 4. The second balloon 3 is welded to the catheter body 1, and similarly, the welding point between the second balloon 3 and the catheter body 1 is sealed. The proximal end of the second balloon 3 is connected to the sliding ring 4 by bonding, and the sliding ring 4 is sleeved on the catheter body 1 and can slide along the catheter body 1.
[0057] The sliding ring 4 is preferably made of a stainless steel ring, which has a certain structural strength and will not be deformed as the second balloon 3 expands, thereby affecting its use.
[0058] Reference Figures 5 to 8 , the infusion channel 41 penetrates the sliding ring 4 in the axial direction, and the infusion tube 5 is welded to the proximal opening of the infusion channel 41, and the contrast agent can be injected into the second balloon 3 through the infusion tube 5. It should be noted that the infusion tube 5 preferably adopts a medical silicone tube, so that the infusion tube 5 can move with the sliding of the sliding ring 4, reducing the influence of the infusion tube 5 on the sliding of the sliding ring 4. The proximal end of the sealing connection membrane 6 is sealed and bonded to the side wall of the first balloon 2, and the distal end is sealed and connected to the side wall of the sliding ring 4. It should be noted that the connection between the sealing connection membrane 6 and the sliding ring 4 does not cover the infusion channel 41, in order to avoid the sealing connection membrane 6 blocking the infusion channel 41 so that the contrast agent cannot pass through, so that the contrast agent can stably enter the second balloon 3. Because the sliding ring 4 can slide, the connection between the sliding ring 4 and the catheter body 1 cannot be kept sealed. Another function of setting the sealing membrane is to prevent the liquid entering the second balloon 3 from leaking.
[0059] After the contrast agent is filled, the sliding ring 4 slides along the catheter body 1 under pressure. The purpose of setting the sliding ring 4 is to improve the compliance of the second balloon 3. The principle is that after the second balloon 3 is squeezed, it pushes the sliding ring 4 to slide along the catheter body 1, so that the second balloon 3 is deformed, which can better improve the fit with the stenosis and avoid excessive squeezing of the inner wall of the blood vessel. The second balloon 3 is filled between the first balloon 2 and the stenosis, so that the balloon and the stenosis have a better fit effect, can better adapt to the diameter changes of long blood vessels, and improve the surgical effect.
[0060] Reference Figures 5 to 8 When in use, first inject contrast agent into the second balloon 3, and the second balloon 3 expands initially. At this time, the second balloon 3 does not need to be filled with contrast agent. Then inject contrast agent into the first balloon 2, and squeeze the second balloon 3 after the first balloon 2 expands, so that the contrast agent in the second balloon 3 is gradually squeezed out, and the second balloon 3 is deformed. The deformed second balloon 3 fits better at the stenosis of the blood vessel and can better adapt to the unevenness of the stenosis of the blood vessel. In this embodiment, even if the diameter of the blood vessel is constantly changing, compared with the ordinary balloon, the second balloon 3 of the present invention can better adapt to the diameter of the blood vessel and improve the fitting effect.
[0061] By arranging the first balloon 2 and the second balloon 3 so that the processes of injecting contrast agent do not affect each other, it is convenient for doctors to operate.
[0062] By arranging the second balloon 3 to cover the first balloon 2, the first balloon 2 plays a role of stable support, and the second balloon 3 is used to improve the compliance with the radial changes of the blood vessels, which can achieve better support and expansion functions and improve the surgical success rate of the balloon catheter.
[0063] In a preferred embodiment of the present application, the hardness of the first balloon 2 is greater than that of the second balloon 3. The second balloon 3 is relatively compliant and is more easily deformed after being squeezed, so as to achieve better fit with the inner wall of the blood vessel and improve the permeability to a certain extent. The first balloon 2 has strong support, which can provide stable support for the second balloon 3 and improve the expansion effect.
[0064] In a preferred embodiment of the present invention, the sealing connection membrane 6 is annular and does not allow liquid or gas to pass through. The sealing connection membrane 6 is a component made of PU or silicone, which has little impact on the environment in the blood vessel and can ensure a stable sealing function. At the same time, the sealing connection membrane 6 is elastic and can expand or contract with the sliding of the sliding ring 4 to improve stability.
[0065] In a preferred embodiment of the present invention, the distance between the side wall of the second balloon 3 and the side wall of the first balloon 2 gradually increases from the distal end to the proximal end. By setting the space at the proximal end of the second balloon 3 larger than the space at the distal end, less contrast agent can be filled into the distal end, reducing the pressure at the distal end, so as to adapt to the shape of a long blood vessel with a narrow distal end and a wide proximal end.
[0066] In a preferred embodiment of the present invention, a sliding layer 42 is provided on the inner ring surface of the sliding ring 4 in contact with the side wall of the catheter body 1. The sliding layer 42 is a circular ring bonded to the inner ring surface of the sliding ring 4, and the sliding layer 42 preferably adopts a hydrophilic coating, which is a hydrogel coating. The main component of the hydrogel coating is a commercially available medical grade hydrogel, which can be made of polysaccharides, polypeptides, polymers and other materials, and can gather water to form a water film with low surface friction, thereby reducing the friction coefficient.
[0067] In a preferred embodiment of the present invention, the first balloon 2 is a non-compliant balloon, and the second balloon 3 is a compliant balloon. The second balloon 3 is preferably made of PET material or PU material, both of which have good biocompatibility and are less irritating to human tissue. At the same time, it has certain flexibility and elasticity to improve the compliance of the second balloon 3. The proximal and distal blood vessels can be fully expanded at the same time to reduce the risk of reoperation for the patient. The first balloon 2 is made of nylon (polyamide), so that the first balloon 2 has excellent strength and toughness, and can withstand higher pressure without obvious deformation. In some embodiments, a cross-linking agent can also be added to the first balloon 2 to improve the deformation resistance.
[0068] In a preferred embodiment of the present invention, the proximal Luer of the catheter body 1 is connected with a Y-type valve 7, the infusion tube 5 passes through a fork of the Y-type valve 7, and the main channel of the Y-type valve 7 is connected with the inner cavity 11. The Luer connection is to prevent leakage at the connection between the Y-type valve 7 and the catheter body 1. The main channel of the Y-type valve 7 is used to inject contrast agent into the first balloon 2, and the fork is used to inject contrast agent into the second balloon 3. The injection of the two balloons does not affect each other. The use of the Y-type valve 7 is more convenient and convenient for doctors to operate.
[0069] In a preferred embodiment of the present invention, the wall thickness of the first balloon 2 and the second balloon 3 is uniformly set. The thickness of the first balloon 2 and the second balloon 3 is uniformly set so that the structure of the first balloon 2 and the second balloon 3 is more stable after expansion, and the occurrence of weak points is reduced, thereby reducing the possibility of rupture of the first balloon 2 and the second balloon 3.
[0070] In a preferred embodiment of the present invention, the first balloon 2 is made of the same material as a whole, and the first balloon 2 is nylon (polyamide) or PET. By using the same material and thickness, the first balloon 2 and the second balloon 3 can be evenly stressed. In the case where the stenosis is relatively smooth, balloons of the same material and thickness are preferably used to meet the opening requirements, saving costs.
[0071] In a preferred embodiment of the present invention, a developing ring 8 is provided at the distal end of the catheter body 1. Specifically, the distal end of the catheter body 1 is welded with the developing ring 8, which is used to assist doctors in determining whether the first balloon 2 is in place, thereby facilitating surgical operations.
[0072] The following is a detailed description of a balloon catheter suitable for treating long vascular lesions according to the present invention through specific embodiments.
[0073] Example 1
[0074] Reference Figure 1 and Figure 2 This embodiment provides a balloon catheter suitable for long vascular lesions, including a catheter body 1, the distal end of which is connected to a first balloon 2 by welding or bonding, the first balloon 2 being made of nylon material, having a certain tensile strength, and being able to withstand a certain pressure without breaking during the filling process. The catheter body 1 is provided with a cavity penetrating along the axial direction, and the catheter body 1 is provided with a connecting channel 12 connecting the first balloon 2 and the inner cavity 11. The catheter body 1 is preferably made of stainless steel material, which has certain support and passability.
[0075] Contrast agent is injected along the cavity and enters the first balloon 2. After being filled with the contrast agent, the first balloon 2 expands under the pressure of the contrast agent, gradually adheres to the inner wall of the blood vessel, and squeezes out the stenosis.
[0076] The diameter of the first balloon 2 gradually increases from the distal end to the proximal end, and the whole is tapered. By setting the proximal diameter of the first balloon 2 to be larger than the distal diameter, the first balloon 2 can adapt to the shape change of the longer blood vessel after expansion, so that the proximal end is closely attached to the proximal end of the blood vessel, and the distal end is closely attached to the distal end of the blood vessel, thereby improving the opening effect of the stenosis.
[0077] Example 2
[0078] Reference Figures 3 to 6 In this embodiment, a second balloon 3 covering a first balloon 2 is bonded or crimped onto the catheter body 1, a sliding ring 4 is bonded to the proximal end of the second balloon 3, a through-infusion channel 41 is provided on the sliding ring 4, an infusion tube 5 is connected to the proximal end of the sliding ring 4, a sealing connection film 6 is provided at the proximal end of the first balloon 2, and the proximal end of the sealing connection film 6 is connected to the sliding ring 4. The sliding ring 4 is sleeved on the catheter body 1 and can slide along the catheter body 1.
[0079] The sliding ring 4 is preferably made of a stainless steel ring, which has a certain structural strength and will not be deformed as the second balloon 3 expands, thereby affecting its use.
[0080] The infusion channel 41 penetrates the sliding ring 4 in the axial direction, and the infusion tube 5 is welded to the proximal opening of the infusion channel 41 . The contrast agent can be injected into the second balloon 3 through the infusion tube 5 .
[0081] Preferably, the infusion tube 5 is preferably made of a medical silicone tube, so that the infusion tube 5 can move with the sliding of the sliding ring 4, thereby reducing the influence of the infusion tube 5 on the sliding of the sliding ring 4.
[0082] Preferably, the connection between the sealing connection film 6 and the sliding ring 4 does not cover the infusion channel 41, in order to prevent the sealing connection film 6 from blocking the infusion channel 41 so that the contrast agent cannot pass through, so that the contrast agent can stably enter the second balloon 3. Since the sliding ring 4 can slide, the connection between the sliding ring 4 and the catheter body 1 cannot be sealed, and another function of providing the sealing film is to prevent the liquid entering the second balloon 3 from leaking.
[0083] After the contrast agent is filled, the sliding ring 4 slides along the catheter body 1 under pressure. The sliding ring 4 can improve the compliance of the second balloon 3 and avoid excessive squeezing of the inner wall of the blood vessel. The second balloon 3 is filled between the first balloon 2 and the stenosis, so that the balloon and the stenosis can be better fitted, and the diameter change of the long blood vessel can be better adapted, thereby improving the surgical effect.
[0084] Reference Figures 5 to 8 When in use, first inject contrast agent into the second balloon 3, and the second balloon 3 expands initially. At this time, the second balloon 3 does not need to be filled with contrast agent. Then inject contrast agent into the first balloon 2, and squeeze the second balloon 3 after the first balloon 2 expands, so that the contrast agent in the second balloon 3 is gradually squeezed out, and the second balloon 3 is deformed. The deformed second balloon 3 fits better at the stenosis of the blood vessel and can better adapt to the unevenness of the stenosis of the blood vessel. In this embodiment, even if the diameter of the blood vessel is constantly changing, compared with the ordinary balloon, the second balloon 3 of the present invention can better adapt to the diameter of the blood vessel and improve the fitting effect.
[0085] By arranging the second balloon 3 to cover the first balloon 2, the first balloon 2 plays a role of stable support, and the second balloon 3 is used to improve the compliance with the radial changes of the blood vessels, which can achieve better support and expansion functions and improve the surgical success rate of the balloon catheter.
[0086] In a preferred embodiment of the present application, the hardness of the first balloon 2 is greater than that of the second balloon 3. The second balloon 3 is relatively compliant and is more easily deformed after being squeezed, so as to achieve better fit with the inner wall of the blood vessel and improve the permeability to a certain extent. The first balloon 2 has strong support, which can provide stable support for the second balloon 3 and improve the expansion effect.
[0087] In a preferred embodiment of the present invention, the sealing connection membrane 6 is annular and does not allow liquid or gas to pass through. The sealing connection membrane 6 is a component made of PU or silicone, which has little impact on the environment in the blood vessel and can ensure a stable sealing function. At the same time, the sealing connection membrane 6 is elastic and can expand or contract with the sliding of the sliding ring 4 to improve stability.
[0088] In a preferred embodiment of the present invention, the distance between the side wall of the second balloon 3 and the side wall of the first balloon 2 gradually increases from the distal end to the proximal end. By setting the space at the proximal end of the second balloon 3 larger than the space at the distal end, less contrast agent can be filled into the distal end, reducing the pressure at the distal end, so as to adapt to the shape of a long blood vessel with a narrow distal end and a wide proximal end.
[0089] In a preferred embodiment of the present invention, a sliding layer 42 is provided on the inner ring surface of the sliding ring 4 in contact with the side wall of the catheter body 1. The sliding layer 42 is a circular ring bonded to the inner ring surface of the sliding ring 4, and the sliding layer 42 preferably adopts a hydrophilic coating, which is a hydrogel coating. The main component of the hydrogel coating is a commercially available medical grade hydrogel, which can be made of polysaccharides, polypeptides, polymers and other materials, and can gather water to form a water film with low surface friction, thereby reducing the friction coefficient.
[0090] In a preferred embodiment of the present invention, the first balloon 2 is a non-compliant balloon, and the second balloon 3 is a compliant balloon. The second balloon 3 is preferably made of PET material or PU material, both of which have good biocompatibility and are less irritating to human tissue. At the same time, it has certain flexibility and elasticity to improve the compliance of the second balloon 3. The proximal and distal blood vessels can be fully expanded at the same time to reduce the risk of reoperation for the patient. The first balloon 2 is made of nylon (polyamide), so that the first balloon 2 has excellent strength and toughness, and can withstand higher pressure without obvious deformation. In some embodiments, a cross-linking agent can also be added to the first balloon 2 to improve the deformation resistance.
[0091] The proximal Luer of the catheter body 1 is connected with a Y-type valve 7, and the infusion tube 5 passes through a fork of the Y-type valve 7, and the main channel of the Y-type valve 7 is connected with the inner cavity 11. The advantage of the Luer connection is to prevent leakage at the connection between the Y-type valve 7 and the catheter body 1. The main channel of the Y-type valve 7 is used to inject contrast agent into the first balloon 2, and the fork is used to inject contrast agent into the second balloon 3. The injection of the two balloons does not affect each other. The use of the Y-type valve 7 is convenient for doctors to operate.
[0092] In summary: the present invention arranges a first balloon 2 and a second balloon 3. The first balloon 2 expands under the pressure of the contrast agent, gradually fits against the inner wall of the blood vessel, and squeezes open the stenosis. The second balloon 3 has better compliance and can be deformed by being squeezed from both the inside and outside during the expansion of the first balloon 2. The deformed second balloon 3 can better fit against the blood vessel wall, thereby improving the opening effect of the stenosis.
[0093] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.
Claims
1. A balloon catheter suitable for treating long vascular lesions, characterized in that: It comprises a catheter body (1); A first balloon (2) is arranged at the distal end of the catheter body (1); Wherein, the proximal diameter of the first balloon (2) is greater than the distal diameter; A penetrating inner cavity (11) is provided in the middle of the catheter body (1), and a connecting channel (12) connecting the first balloon (2) and the inner cavity (11) is provided on the side wall of the catheter body (1).
2. A balloon catheter suitable for treating long vascular lesions according to claim 1, characterized in that: The catheter body (1) is provided with a second balloon (3) covering the first balloon (2); the proximal end of the second balloon (3) is connected to a sliding ring (4); the sliding ring (4) is provided with a penetrating infusion channel (41); the proximal end of the sliding ring (4) is connected to an infusion tube (5); the proximal end of the first balloon (2) is provided with a sealing connection membrane (6); the proximal end of the sealing connection membrane (6) is connected to the sliding ring (4).
3. A balloon catheter suitable for treating long vascular lesions according to claim 2, characterized in that: The sealing connection membrane (6) is annular and does not allow liquid or gas to pass through.
4. A balloon catheter suitable for treating long vascular lesions according to claim 3, characterized in that: The distance between the side wall of the second balloon (3) and the side wall of the first balloon (2) gradually increases from the distal end to the proximal end.
5. A balloon catheter suitable for treating long vascular lesions according to claim 4, characterized in that: A sliding layer (42) is provided on the inner annular surface of the sliding ring (4) which contacts the side wall of the catheter body (1).
6. A balloon catheter suitable for treating long vascular lesions according to claim 2, characterized in that: The first balloon (2) is a non-compliant balloon, and the second balloon (3) is a compliant balloon.
7. A balloon catheter suitable for treating long vascular lesions according to claim 2, characterized in that: The proximal Luer of the catheter body (1) is connected to a Y-type valve (7), the infusion tube (5) passes through a fork of the Y-type valve (7), and the main channel of the Y-type valve (7) is connected to the inner cavity (11).
8. The balloon catheter suitable for treating long vascular lesions according to claim 2, characterized in that: The wall thicknesses of the first balloon (2) and the second balloon (3) are uniformly arranged.
9. A balloon catheter suitable for treating long vascular lesions according to any one of claims 1 to 8, characterized in that: A developing ring (8) is provided at the distal end of the catheter body (1).
10. A balloon catheter suitable for treating long vascular lesions according to any one of claims 1 to 8, characterized in that: The first balloon (2) is made of the same material as a whole, and the first balloon (2) is nylon (polyamide) or PET.
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