Coronary venous sinus balloon counterpulsation catheter

Abstract

The utility model provides a coronary sinus balloon counterpulsation catheter which comprises a catheter body and a balloon, the catheter body is provided with a first cavity and a second cavity which extend along the axial direction of the catheter body in a penetrating mode, and the first cavity and the catheter body are eccentric; the cross section of the second cavity channel comprises a first contour line and a second contour line, the first contour line is at least one part of a first circle, and the second contour line is at least one part of a second circle; the first contour line is closer to the first cavity than the second contour line, and the concave side of the first contour line and the concave side of the second contour line face the first cavity; the width of the second cavity channel meets a preset relation; the balloon is connected to the peripheral face of the far end of the catheter body in a sealed mode and communicated with the second cavity channel. According to the coronary venous sinus balloon counterpulsation catheter, due to the arrangement mode of the first cavity and the second cavity, filling liquid flowing in the second cavity has small resistance and high flow speed, in this way, the coronary venous sinus balloon counterpulsation catheter can adopt liquid such as normal saline to replace gas to serve as a filling medium, the situation of aeroembolism caused by balloon rupture is avoided, and the balloon counterpulsation catheter has the advantages of being simple in structure and convenient to use. And the use safety is improved.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and particularly relates to a coronary sinus balloon counterpulsation catheter. Background Art

[0002] Acute ST-segment elevation myocardial infarction (STEMI) is a cardiovascular disease with rapid disease progression, high disability rate and mortality rate. Clinically, percutaneous coronary intervention (PCI) to promptly restore the patency of the epicardial blood vessels of patients is the main means of treating STEMI. However, after successful revascularization, up to 30% of STEMI patients still experience further enlargement of the myocardial ischemic area due to the ineffective opening of previously blocked microchannels, which leads to higher mortality and recurrence rates. Therefore, improving microvascular circulation function, including solving problems such as microvascular embolism and microvascular remodeling, is of utmost importance in improving the postoperative quality of life, reducing recurrence rates and mortality rates of STEMI patients.

[0003] The coronary sinus balloon counterpulsation catheter is placed in the coronary sinus (CS) through a venous vascular access. By controlling the coronary sinus balloon counterpulsation catheter to periodically expand and contract through a counterpulsation therapeutic instrument, the blood flow in the CS can be intermittently blocked, thereby controlling the intermittent increase and decrease of the CS blood pressure, promoting the reflux of coronary venous blood and redistributing it to the myocardial damaged area, which can improve myocardial perfusion and microcirculation dysfunction after PCI, reduce the myocardial infarction area, and improve cardiac function.

[0004] In the prior art, most coronary sinus balloon counterpulsation catheters use gas as the filling medium for the balloon. The reason is that the jet velocity of gas is fast and the resistance is small, which can quickly achieve the filling and pressure relief of the balloon, and can make the expansion and contraction frequency of the balloon match the expansion and contraction frequency of the heart. However, once the balloon ruptures, the gas used as the filling medium enters the blood circulation system from the rupture of the balloon and forms bubbles in the blood vessels, which may cause serious health problems or even death. In contrast, if physiological saline is used as the filling medium for the balloon, it has significant safety advantages. Physiological saline refers to a sodium chloride aqueous solution with a mass percentage of 0.9%, which has a high compatibility with the human physiological environment. Even if the balloon ruptures, the physiological saline entering the blood circulation system from the rupture of the balloon will not cause harm to the human body because it is miscible with the blood.

[0005] Although normal saline has obvious advantages in terms of safety as a filling medium, the physical properties of the liquid determine that normal saline exhibits high resistance and slow flow rate when transmitted in the catheter. As a result, there are problems such as long filling and pressure relief times of the balloon, which reduces the expansion and contraction frequencies of the balloon, making it difficult for the expansion and contraction frequencies of the balloon to match the expansion and contraction frequencies of the heart. From the perspective of fluid mechanics, the flow rate of the liquid in the catheter is closely related to the size of the flow channel cross-section. However, specifically in the field of medical devices, due to the need to meet the coordinated use of various devices and also considering the inner diameter of the blood vessel itself, during the design of the catheter, the inner and outer diameters of the catheter are often limited by the access devices (such as guide wires, catheter sheaths, etc.) and blood vessel size used in coordination, and it is not easy to increase the flow rate of the liquid by expanding the inner and outer diameters of the catheter, thereby improving the expansion and contraction frequencies of the coronary sinus balloon counterpulsation catheter. Therefore, there are certain difficulties in using normal saline as the filling medium for the coronary sinus counterpulsation balloon clinically. Summary of the Invention

[0006] The purpose of the present invention is to provide a coronary sinus balloon counterpulsation catheter, aiming to enable the coronary sinus balloon counterpulsation catheter to use normal saline or a liquid with similar properties as the filling medium, and improve the use safety of the coronary sinus balloon counterpulsation catheter.

[0007] To achieve the above purpose, the present invention provides a coronary sinus balloon counterpulsation catheter, including a catheter body and a balloon. A first channel and a second channel that extend axially through the catheter body and are isolated from each other are provided on the catheter body; the first channel is eccentrically arranged with respect to the catheter body; the cross-section of the second channel includes a first contour line and a second contour line. The first contour line is at least a part of a first circle, and the second contour line is at least a part of a second circle; the first contour line is closer to the first channel than the second contour line, and the concave sides of the first contour line and the second contour line both face the first channel; the balloon is sealingly connected to the outer peripheral surface of the distal end of the catheter body and communicates with the second channel;

[0008] The width of the second channel at a specified position of the second circle satisfies the following relational expression:

[0009]

[0010] Wherein, h represents the width of the second channel at the specified position of the second circle, D represents the diameter of the second circle, d represents the diameter of the first circle, e is the distance between the center of the first circle and the center of the second circle, θ represents the angle formed by the first straight line and the second straight line, the first straight line refers to the straight line passing through the center of the first circle and the center of the second circle, and the second straight line refers to the straight line passing through the specified position and the center of the second circle;

[0011] The width of the second channel refers to the dimension of the second channel in the radial direction of the first circle.

[0012] Optionally, the cross-section of the first channel is circular, and the first channel is coaxial with the first circle; the catheter body is coaxial with the second circle.

[0013] Optionally, the balloon includes a proximal balloon segment and a distal balloon segment that are symmetrically arranged and directly connected. The outer diameter and inner diameter of the proximal balloon segment both increase in the proximal-to-distal direction, and the outer diameter and inner diameter of the distal balloon segment both decrease in the proximal-to-distal direction.

[0014] Optionally, the balloon is configured to be elastic.

[0015] Optionally, the material for preparing the balloon includes any one of silica gel, polyurethane, and polyether block polyamide.

[0016] Optionally, it further includes a liquid suction device and a power mechanism. The liquid suction device includes a housing and a piston. The housing has an inner cavity, and a connection hole communicating with the inner cavity is further provided on the housing. The liquid suction device is connected to the proximal end of the catheter body through the connection hole and communicates with the second channel; the piston is at least partially disposed in the channel, and the piston is further connected to the power mechanism. The power mechanism is used to drive the piston to reciprocate along the axial direction of the connection hole.

[0017] Optionally, the power mechanism includes a motor, a reducer, and a transmission mechanism connected in sequence; the reduction ratio of the reducer is 10:1 to 1:1, and the transmission mechanism is connected to the piston.

[0018] Optionally, the motor is a DC motor; and / or,

[0019] The reducer is a planetary reducer.

[0020] Optionally, the catheter body includes a proximally located tube section and a distally located tube section that are axially connected, and the distally located tube section is configured to be bendable at least at its proximal end; the balloon is sealingly connected to the outer peripheral surface of the distally located tube section; a flow hole communicating with the first channel is further provided on the side wall of the distally located tube section, and the flow hole is located on the distal side of the balloon.

[0021] Optionally, when the catheter body is bent, the angle formed by the axis of the distally located tube section and the axis of the proximally located tube section is less than or equal to 135°; and / or,

[0022] The axial length of the distally located tube section is 15 mm to 50 mm.

[0023] Optionally, it further includes a pressure monitoring element, which is connected to the proximal end of the catheter body and is correspondingly arranged with the first channel and / or the second channel.

[0024] Compared with the prior art, the coronary sinus balloon counterpulsation catheter of the present utility model has the following advantages:

[0025] The aforementioned coronary sinus balloon counterpulsation catheter includes a catheter body and a balloon. The catheter body is provided with a first channel and a second channel that extend axially through the catheter body and are isolated from each other; the first channel is eccentrically arranged with respect to the catheter body. The cross-section of the second channel includes a first contour line and a second contour line. The first contour line is at least a part of a first circle, and the second contour line is at least a part of a second circle; the first contour line is closer to the first channel than the second contour line, and the concave sides of both the first contour line and the second contour line face the first channel; the balloon is sealingly connected to the distal outer peripheral surface of the catheter body and communicates with the second channel; the width of the second channel at a specified position of the second circle satisfies: In the formula, h represents the width of the second channel at the specified position of the second circle, D represents the diameter of the second circle, d represents the diameter of the first circle, e is the distance between the center of the first circle and the center of the second circle, θ represents the angle formed by the first straight line and the second straight line. The first straight line refers to the straight line passing through the centers of the first circle and the second circle, and the second straight line refers to the straight line connecting the center of the second circle and the specified position. The width of the second channel refers to the dimension of the second channel in the radial direction of the first circle. Among them, the second channel is used for the flow of the filling agent. The arrangement of the first channel and the second channel enables the filling liquid flowing in the second channel to have less resistance and faster flow rate, improving the filling and withdrawal efficiency of the balloon, and making the withdrawal time of the balloon less than or equal to the diastolic period of the ventricle. Furthermore, the coronary sinus balloon counterpulsation catheter can use a liquid such as normal saline instead of gas as the filling medium, avoiding air embolism caused by balloon rupture and improving the use safety. Brief Description of the Drawings

[0026] The drawings are used to better understand the present invention and do not constitute an improper limitation to the present invention. Among them:

[0027] Figure 1 is a schematic structural view of a coronary sinus balloon counterpulsation catheter provided by the present invention according to an embodiment;

[0028] Figure 2 is an A-A cross-sectional view of the catheter body of the coronary sinus balloon counterpulsation catheter provided by the present invention according to an embodiment. In the illustration, the first circle is coaxial with the first channel, and the second circle is coaxial with the catheter body;

[0029] Figure 3 is an A-A cross-sectional view of the catheter body of the coronary sinus balloon counterpulsation catheter provided by the present invention according to another embodiment. In the illustration, the first circle is not coaxial with the first channel, and the second circle is coaxial with the catheter body;

[0030] Figure 4 is a partial enlarged schematic view of the coronary sinus balloon counterpulsation catheter provided by the present invention according to an embodiment;

[0031] Figure 5 is a cross-sectional schematic view of the catheter body of a balloon catheter in the prior art. In the illustration, the catheter body includes a first channel and a second channel arranged coaxially.

[0032] [Explanation of the reference numerals is as follows]:

[0033] 10, 100 - catheter body, 11, 101 - first lumen, 12, 102 - second lumen, 12a, 102a - first contour line, 12b, 102b - second contour line, 13, 103 - partition wall, 104 - flow-through hole, 110 - proximal tube segment, 120 - distal tube segment, 200 - balloon, 210 - proximal balloon segment, 220 - distal balloon segment, 300 - connector, 310 - first connection part, 320 - second connection part, 330 - third connection part, 400 - pressure monitoring element, 500 - aspiration device, 600 - power mechanism. Detailed implementation manners

[0034] The following uses specific specific examples to illustrate the implementation manners of the present utility model. Those skilled in the art can easily understand the other advantages and effects of the present utility model from the content disclosed in this specification. The present utility model can also be implemented or applied through other different specific implementation manners. The details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present utility model. It should be noted that the diagrams provided in this embodiment only illustrate the basic concept of the present utility model in a schematic manner. Therefore, only the components related to the present utility model are shown in the diagrams, rather than being drawn according to the number, shape, and size of the components during actual implementation. The type, quantity, and ratio of each component during actual implementation can be arbitrarily changed, and the component layout type may also be more complex.

[0035] In addition, each of the following description contents of the embodiments has one or more technical features. However, this does not mean that those who use the present utility model must implement all the technical features in any one embodiment at the same time, or can only separately implement a part or all of the technical features in different embodiments. In other words, on the premise that implementation is possible, those skilled in the art can, according to the disclosure content of the present utility model and depending on the design specifications or implementation requirements, selectively implement some or all of the technical features in any one embodiment, or selectively implement the combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility during the implementation of the present utility model.

[0036] As used in this specification, the singular forms "a", "an", and "the" include plural referents, and the plural form "plural" includes more than two referents, unless the context clearly indicates otherwise. As used in this specification, the term "or" is generally used in the sense of including "and / or", unless the context clearly indicates otherwise, and the terms "mounted", "connected", and "coupled" should be understood broadly. For example, it may be a fixed connection, a detachable connection, or an integral connection. It may be a mechanical connection or an electrical connection. It may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements or the interaction relationship between two elements. The relational terms such as "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly specify the quantity of the indicated technical features. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0037] The terms "proximal" and "distal" involved herein are described based on the relative positions and relative orientations of the respective elements and components of the medical device. Although non-limiting, "proximal" is generally the end of the medical device that is closer to the operator during normal use, and "distal" is the end that is farther from the operator.

[0038] For a conventional coronary sinus balloon counterpulsation catheter in the prior art, if a liquid is used as the filling medium, due to the large flow resistance and slow flow rate of the liquid, the filling and deflation speeds of the balloon are both long, making it difficult for the withdrawal time of the conventional coronary sinus balloon counterpulsation catheter to match the patient's heart rate and failing to achieve the therapeutic effect. The liquid here includes but is not limited to normal saline.

[0039] The purpose of the present utility model is to provide a coronary sinus balloon counterpulsation catheter that can use a liquid such as normal saline as the filling medium. By changing the structural configuration, the filling and deflation durations of the balloon are shortened, so that the withdrawal time of the coronary sinus balloon counterpulsation catheter can match the patient's heart rate. For the convenience of description, the filling medium in the liquid state will be referred to as the filling liquid hereinafter.

[0040] To facilitate the understanding of the present utility model, a brief introduction to the creation process of the present utility model will be given first.

[0041] Figure 5 A balloon catheter in the prior art is provided. As Figure 5As shown, the existing balloon catheter includes a catheter body 10 and a balloon (not shown in the figure). A first channel 11 and a second channel 12 extending axially through the catheter body 10 are formed on the catheter body 10. The first channel 11 and the second channel 12 are coaxially arranged and isolated by a partition wall 13. The second channel 12 surrounds the outer periphery of the first channel 11. In the cross-section of the catheter body 10, the second channel 12 includes a first contour line 12a and a second contour line 12b which are coaxially arranged, and both the first contour line 12a and the second contour line 12b are circular. Among them, the first channel 11 is used for threading a guide wire, and the second channel 12 is used for the flow of a filling medium.

[0042] If the filling liquid is introduced into the second channel 12 of the balloon catheter in this prior art. Then, for the existing balloon catheter, the filling liquid forms a laminar flow in the second channel 12, and its volumetric flow rate per unit volume can be expressed as Q, and there is the following formula (1):

[0043]

[0044] In the formula, d represents the diameter of the first contour line 12a; D represents the diameter of the second contour line 12b; h represents the width of the second channel 12, that is, the dimension of the second channel 12 in the radial direction of the catheter body 10, and its value is μ represents the viscosity of the filling liquid. For a specified filling liquid, μ is a constant value; L represents the axial length of the catheter body 10; ΔP represents the pressure difference of the filling liquid at both axial ends of the second channel 12.

[0045] When the balloon in the filled state is being withdrawn, the withdrawal time, the volume of the balloon, and the flow rate of the filling liquid conform to the following formula (2):

[0046]

[0047] In formula (2), t is the withdrawal time; V is the volume of the balloon, which is equal to the volume of the filling liquid located in the balloon when the balloon is filled. When ignoring the wall thickness of the balloon, V is approximately equal to the volume V0 of the balloon in the filled state.

[0048] Combining formula (1) and formula (2), formula (3) is obtained:

[0049]

[0050] As can be seen from Equation (3), for the balloon catheter having the first channel 11 and the second channel 12 arranged coaxially, the withdrawal time can be shortened by reducing the volume of the balloon, reducing the length of the catheter body 10, increasing the inner diameter of the outer tube body, reducing the outer diameter of the inner tube body, or increasing the pressure difference of the filling fluid at the two axial ends of the second channel 12. However, those skilled in the art know that for the design of medical catheters, the inner and outer diameters of the inner tube body, the inner and outer diameters of the outer tube body, the length of the catheter body, and the pressure difference of the filling fluid at the two axial ends of the second channel 12 need to be determined according to clinical treatment and usage requirements and cannot be easily changed. That is, for the Figure 4 shown balloon catheter, it is difficult to optimize so that it can still be applicable to coronary sinus counterpulsation when using the filling fluid.

[0051] In view of this, the inventor considered changing the arrangement of the first channel and the second channel to change the hydrodynamics of the filling fluid flowing through the second channel, thereby achieving the purpose of shortening the withdrawal time of the balloon catheter.

[0052] The inventor found through a large number of studies that when the structure of the catheter body of the balloon catheter is as Figure 2 and Figure 3 shown, by reasonably setting the relevant parameters of the second channel, the above purpose can be achieved.

[0053] Specifically, as Figure 2 and Figure 3 shown, the catheter body 100 is provided with a first channel 101 and a second channel 102 that extend axially through the catheter body and are separated by a partition wall 103. The first channel 101 is eccentrically arranged with respect to the catheter body 100. The second channel 102 includes a first contour line 102a and a second contour line 102b. The first contour line 102a is at least a part of a first circle, and the second contour line 102b is at least a part of a second circle. That is, the first contour line 102a is an arc, and the circle where the arc is located is the first circle (as Figure 3 shown), or the first contour line 102a is the entire first circle (as Figure 2 shown); the second contour line 102b is an arc, and the circle where the arc is located is the second circle (as Figure 3 shown), or the second contour line 102b is the entire second circle (as Figure 2 shown). The first contour line 102a is closer to the first channel 101 than the second contour line 102b. Thus, the first circle is equivalent to the Figure 4 first contour line 12a, and the second circle is equivalent to the Figure 4The second contour line 12b in it. The width of the second channel 102 at the specified position S of the second circle satisfies the following formula (4):

[0054]

[0055] In the formula, h represents the width of the second channel 102 at the specified position S of the second circle, D represents the diameter of the second circle, d represents the diameter of the first circle, and e is the distance between the center O1 of the first circle and the center O2 of the second circle. It can be understood that e is less than or equal to θ represents the angle formed by the first straight line l1 and the second straight line l2. The first straight line l1 refers to the straight line passing through the center O1 of the first circle and the center O2 of the second circle, and the second straight line l2 refers to the straight line passing through the center O2 of the second circle and the specified position S. It should be noted that the width of the second channel 102 refers to the dimension of the second channel 102 in the radial direction of the first circle. Thus, in the cross-section of the catheter body 100, the width of the second channel 102 at the specified position S of the second circle refers to the dimension of the part between the first circle and the second circle of the straight line l3 passing through the center O1 of the first circle and the specified position S. It should be understood that the specified position S is on the second contour line 102b.

[0056] For the catheter body 100, when the filling liquid is introduced into the second channel 102, the unit volume flow rate Q of the filling liquid in the second channel 102 conforms to the following formula (5):

[0057]

[0058] Substitute formula (4) into formula (5) and calculate to obtain the following formula (6):

[0059]

[0060] Substitute Figure 2 and Figure 3 When the catheter body 100 shown is applied to a balloon catheter, combining formula (2) and formula (6), it is obtained that the withdrawal time t of the balloon catheter conforms to the following formula (7):

[0061]

[0062] Comparing formula (3) and formula (7), it can be found that when the diameter of the first circle is equal to the diameter of the first contour line 12a, the diameter of the second circle is equal to the diameter of the second contour line 12b, the volume of the balloon 100 is the same, the filling liquid is the same, and the pressure difference of the filling liquid at the axial two ends of the second channel is the same, the application ofFigure 2 and Figure 3 the balloon catheter of the catheter body 100 shown in has a shorter aspiration time than that of the balloon catheter of the catheter body 10 shown in Figure 4 .

[0063] Therefore, the structure of the coronary sinus balloon counterpulsation catheter provided by the embodiment of the present invention is as shown in Figure 1 , including a catheter body 100 and a balloon 200. Among them, the cross-section of the catheter body 100 is as shown in Figure 2 and Figure 3 , referring to Figure 2 and Figure 3 . A first channel 101 and a second channel 102 are provided on the catheter body 100. Both the first channel 101 and the second channel 102 extend axially through the catheter body 100, and the first channel 101 and the second channel 102 are isolated by a partition wall 103. The first channel 101 is eccentrically arranged with the catheter body 100. The cross-section of the second channel 102 includes a first contour line 102a and a second contour line 102b. The first contour line 102a is at least a part of a first circle, and the second contour line 102b is at least a part of a second circle. The first contour line 102a is closer to the first channel 101 than the second contour line 102b, and the concave sides of both the first contour line 102a and the second contour line 102b face the first channel 101. The balloon 200 is sealingly connected to the outer peripheral surface of the distal end of the catheter body 100 and communicates with the second channel 102 for the circulation of the filling medium. Among them, the width of the second channel 102 at the specified position S of the second contour line 102b satisfies the foregoing formula (4). In this way, the coronary sinus balloon counterpulsation catheter has a shorter aspiration time, can be adapted to the patient's cardiac cycle, and can achieve a better counterpulsation effect.

[0064] Generally, the cross-section of the first channel 101 is circular, and the cross-section of the second channel 102 is crescent-shaped. In some alternative embodiments, the first circle is coaxially arranged with the first channel 101, and the second circle is coaxially arranged with the catheter body 100 (as shown in Figure 2 ). In some other embodiments, the first circle is not coaxially arranged with the first channel 101, while the second circle is coaxially arranged with the catheter body 100 (as shown in Figure 3 ). In still some other embodiments, the first circle is coaxially arranged with the first channel, while the second circle is not coaxially arranged with the catheter body 100. In still some alternative embodiments, the first circle is not coaxially arranged with the first channel 101, and the second circle is not coaxially arranged with the catheter body 100.

[0065] Next, the effects of the coronary sinus balloon counterpulsation catheter provided by the present utility model will be described through several embodiments.

[0066] In the first embodiment, the catheter body 100 is composed of an inner tube body and an outer tube body. Specifically, the outer tube body is sleeved on the outer peripheral surface of the inner tube body, and the inner surface of the outer tube body and the outer surface of the inner tube body are bonded by an adhesive. The size of the adhesive in the radial direction of the outer tube body is 0.03 mm ((thickness of the glue)), the inner diameter of the outer tube body is 1.72 mm, and the outer diameter of the inner tube body is 1.25 mm. Thus, in the catheter body 100, the lumen of the inner tube body constitutes the first channel 101, the space between the inner peripheral surface of the outer tube body and the outer peripheral surface of the inner tube body constitutes the second channel 102, and the tube wall of the inner tube body constitutes the partition wall 103 that separates the first channel 101 and the second channel 102. Based on this, the diameter of the first circle is 1.72 mm, the diameter of the second circle is 1.25 mm, and the distance between the center O1 of the first circle and the center O2 of the second circle is 0.21 mm. In addition, the length L of the catheter body 100 is 1000 mm. The volume of the balloon 200 is 0.69 mL. The balloon 200 is filled with physiological saline as the filling liquid, and when the coronary sinus balloon counterpulsation catheter is withdrawn, the pressure difference at both axial ends of the second channel 102 of the physiological saline is 1 atmospheric pressure. The filled balloon 200 is withdrawn, and according to formula (7), the calculated withdrawal time is 0.28 s, and the measured withdrawal time is 0.32 s.

[0067] It should be noted that during the application of the coronary sinus balloon counterpulsation catheter, the reason why the measured withdrawal time is greater than the withdrawal time calculated according to formula (7) is that the adhesive layer bonding the inner tube body and the outer tube body has a certain area, which occupies a part of the space of the second channel 102, resulting in a reduction in the flow area of the filling liquid. To address this issue, during the actual production of the coronary sinus balloon counterpulsation catheter, the area of the adhesive layer connecting the inner tube body and the outer tube body should be controlled to be as small as possible.

[0068] In other embodiments, the catheter body 100 can also be formed by an extrusion method.

[0069] The size parameters of each coronary sinus balloon counterpulsation catheter provided in Embodiments 2 to 9, the withdrawal time calculated according to Formula (7), and the actually measured withdrawal time are shown in Table 1 below. Among the coronary sinus balloon counterpulsation catheters provided in Embodiments 2 to 6, the first circle is coaxial with the first channel 101, and the second circle is coaxial with the catheter body 100. In the coronary sinus balloon counterpulsation catheters provided in Embodiments 7 to 9, the catheter body 100 is formed by extrusion, the first circle is not coaxial with the first channel 101, and the second circle is coaxial with the catheter body 100. In addition, each coronary sinus balloon counterpulsation catheter provided in each embodiment is filled with physiological saline, and when withdrawing, the pressure difference at both axial ends of the physiological saline in the second channel 102 is 1 atmospheric pressure.

[0070] Table 1

[0071]

[0072]

[0073] From the withdrawal time calculated according to Formula (7) and the actually measured withdrawal time in each of the above embodiments, it can be found that the error between the calculated withdrawal time and the actually measured withdrawal time is not greater than 0.04 s. This shows that Formula (7) has extremely high reliability.

[0074] Those skilled in the art know that the coronary sinus balloon counterpulsation catheter itself is a mechanical assist circulation device, which improves the heart function and blood circulation by expanding and contracting the balloon 200 at specific times during the cardiac cycle. Specifically, the balloon 200 is filled during ventricular systole to block the coronary sinus, increasing the pressure in the coronary sinus, forcing more blood to flow retrogradely into the myocardial damaged area, and improving myocardial blood supply. The balloon 200 contracts during ventricular diastole to reduce the pressure in the coronary sinus, allowing blood to flow out of the heart normally, thereby reducing the burden on the heart. It can be seen that as long as the contraction time of the balloon 200, that is, the withdrawal time of the coronary sinus balloon counterpulsation catheter, is less than the duration of ventricular diastole, the effect of reducing the burden on the heart can be achieved, and thus there is a therapeutic effect.

[0075] Taking the average heart rate of adults as 75 beats per minute, each cardiac cycle is on average 0.8 s, of which the ventricular systole is on average 0.27 s and the ventricular diastole is on average 0.53 s. In the above exemplary embodiments, the actually measured withdrawal time of the coronary sinus balloon counterpulsation catheter is not greater than 0.52 s, which is less than the duration of ventricular diastole and can meet the treatment requirements.

[0076] It can be understood that during actual application, a doctor adjusts various parameters of the coronary sinus balloon counterpulsation catheter according to the heart rates of different patients to adjust the withdrawal time of the coronary sinus balloon counterpulsation catheter, so that the withdrawal time can be as matched with the patient's heart rate as possible to achieve the best counterpulsation effect.

[0077] It should be noted that in other embodiments, the catheter body 100 of the coronary sinus balloon counterpulsation catheter can also be formed by extrusion.

[0078] Please refer to Figure 1 and Figure 4 , the catheter body 100 includes a proximal tube section 110 and a distal tube section 120 that are axially connected. The distal tube section 120 is configured to be able to bend at least at its proximal end. Specifically, the distal tube section 120 includes a first sub-segment and a second sub-segment (not labeled in the figure) that are axially connected. The first sub-segment is closer to the proximal tube section 110 than the second sub-segment, and the first sub-segment can bend. Thus, the catheter body 100 can bend at the first sub-segment. The advantage of such a setting is that when the distal end of the coronary sinus balloon counterpulsation catheter 10 is inserted into the coronary sinus, it can better adapt to the shape of the coronary sinus. The balloon 200 is sealingly connected to the outer peripheral surface of the distal tube section 120. Additionally, in some embodiments, the second sub-segment can bend, and in other embodiments, the second sub-segment cannot bend.

[0079] In an embodiment of the present invention, when the catheter body 100 bends, the angle α formed by the axis of the proximal tube section 110 and the axis of the distal tube section 120 is less than or equal to 135°. Additionally, the axial length L1 of the distal tube section 120 is 15 mm to 50 mm.

[0080] When the catheter body 100 is formed by extrusion, the raw material for extruding the catheter body 100 includes a polymer main material. The polymer main material includes but is not limited to at least one of polyamide (PA), polyether block polyamide (Pebax), polyurethane (TPU), and polyvinyl chloride (PVC). Further, the raw material can also include an inorganic additive. The inorganic additive is, for example, an inorganic material with developability. In this way, the catheter body 100 can have developability. Optional inorganic materials with developability include but are not limited to at least one of barium sulfate, bismuth trioxide, bismuth hydroxide, bismuth subcarbonate, and tungsten. In terms of mass percentage, preferably, the addition amount of the inorganic additive is less than or equal to 40%.

[0081] When the catheter body 100 is formed by combining the inner tube body and the outer tube body, the connection method between the inner tube body and the outer tube body is not limited to the aforementioned gluing, and can also be welding or any other suitable method; or, the inner tube material and the outer tube material are not directly connected, but only lean against each other by their own gravity during use. The outer diameter of the inner tube body can be 1.5 mm to 2 mm, and the inner diameter can be 0.45 mm to 1.5 mm. The outer diameter of the outer tube body can be 2 mm to 4 mm, and the inner diameter is 1.5 mm to 2 mm. Among them, the outer tube body is preferably a multi-layer structure, for example, including an inner layer, a middle layer, and an outer layer arranged from the inside out. The material of the inner layer includes medical polymer materials, such as polytetrafluoroethylene. The material of the middle layer is a metal material, such as medical stainless steel. The material of the outer layer includes medical polymer materials. In addition, the outer tube body can also have radiopacity. For example, radiopaque inorganic materials such as barium sulfate and bismuth trioxide are incorporated into the material of the outer layer. In the outer layer, the addition ratio of the radiopaque inorganic material is less than or equal to 60% by mass percentage.

[0082] Regardless of the method used to form the catheter body 100, it is preferably that the overall hardness of the catheter body 100 is 50A - 100D, so that the catheter body 100 has good pushability and controllability.

[0083] Please refer to Figure 1 and Figure 4 , the balloon 200 includes a proximal balloon segment 210 and a distal balloon segment 220 that are symmetrically arranged and directly connected. The outer diameter and inner diameter of the proximal balloon segment 210 both increase in the proximal-to-distal direction, and the outer diameter and inner diameter of the distal balloon segment 220 both increase in the proximal-to-distal direction. In this way, the volume of the balloon 200 can be made as small as possible to shorten the aspiration time.

[0084] The nominal outer diameter C of the balloon 200 when inflated is 4 mm to 16 mm, and the axial length P is 10 mm to 25 mm.

[0085] Furthermore, the balloon 200 is made of an elastic material. Thus, when the balloon 200 is in the inflated state, the balloon 200 stores elastic potential energy by itself. In this way, when aspirating the inflation liquid, the balloon 200 releases the elastic potential energy to facilitate the discharge of the inflation liquid, so as to further shorten the aspiration time. The materials used to manufacture the balloon 200 include, but are not limited to, any one of silicone, polyurethane, and polyether block polyamide.

[0086] Please return to refer to Figure 1The coronary sinus balloon counterpulsation catheter 10 further includes a connector 300, which is connected to the proximal end of the catheter body 100 and includes a first connector portion 310, a second connector portion 320 and a third connector portion 330. The first connector portion 310 is connected to the proximal end of the catheter body 100, and enables the second connector portion 320 to communicate with the first lumen 101, and enables the third connector portion 330 to communicate with the second lumen 102.

[0087] The second connector 320 is used for the guide wire to pass through, and is also arranged corresponding to a pressure monitoring element 400, so that the pressure monitoring element 400 is arranged corresponding to at least one of the first lumen 101 and the second lumen 102. It can be understood that when the pressure monitoring element 400 is arranged corresponding to the first lumen 101, the pressure monitoring element 400 can sense the blood pressure in the coronary sinus when blood enters the first lumen 101; when the pressure monitoring element 400 is arranged corresponding to the second lumen 102, the pressure monitoring element 400 can monitor the filling pressure of the balloon 200 when the balloon 200 is filled. The specific type and setting method of the pressure monitoring element 400 are well known to those skilled in the art and will not be repeated here. It can be understood that the coronary sinus balloon counterpulsation catheter 10 can include a pressure monitoring element 400.

[0088] Furthermore, since the distal end of the catheter body 100 is bendable, in order to ensure that blood still enters the first lumen 101 when the distal end of the catheter body 100 is bent so that the pressure monitoring element 400 can monitor the blood pressure, a flow hole 104 (such as a flow hole 104) communicating with the first lumen 101 is provided on the wall of the distal end tube section 120 of the catheter body 100. Figure 4 As shown in FIG. 1 , when the distal end of the catheter body 100 is bent, blood enters the first lumen 101 from the flow hole 104. It should be understood that the flow hole 104 should be located at the distal end side of the balloon 200.

[0089] The third connector 330 is used to connect to a filling liquid source. The filling liquid source is a suction device 500. The coronary sinus balloon counterpulsation catheter 10 also includes the suction device 500 and a power mechanism 600. The suction device 500 is used to store the filling liquid, and the power mechanism 600 is used to drive the suction device to inject the filling liquid into the balloon 200 to fill the balloon 200, or to withdraw the filling liquid in the balloon 200 to relieve the pressure of the balloon 200.

[0090] The aspiration liquid device 500 includes a housing and a piston (not shown in the figure). The housing is a hollow structure with an inner cavity, and a connection hole communicating with the inner cavity is further provided on the housing. The aspiration liquid device is connected to the third joint 330 through the connection hole to communicate with the second channel 102. The piston is at least partially disposed in the inner cavity, and the piston is further connected to the power mechanism 600 and can perform a reciprocating linear motion along the axial direction of the connection hole under the drive of the power mechanism 600 to approach or move away from the connection hole. The part of the inner cavity on the side of the piston close to the connection hole is used to store the filling liquid. When the piston moves in the direction approaching the connection hole, the filling liquid is perfused into the balloon 200, so that the balloon 200 is filled; when the piston moves in the direction away from the connection hole, the filling liquid is drawn back into the inner cavity, so that the balloon 200 is depressurized.

[0091] In the embodiments of the present invention, the structure of the power mechanism 600 is not particularly limited. In some embodiments, the power mechanism 600 includes a cylinder driven by air pressure; in other embodiments, the power mechanism 600 includes a hydraulic cylinder driven by oil pressure; in still other embodiments, the power mechanism 600 includes an electric drive device driven by electricity.

[0092] In a preferred embodiment, the power mechanism 600 includes an electric drive device, and specifically includes a motor, a reducer, and a transmission mechanism connected in sequence. Among them, the reduction ratio of the reducer is 10:1 to 1:1, and the transmission mechanism is a linear motion mechanism, which is connected to the piston. The reduction ratio refers to the ratio of the input to the output of the reducer.

[0093] Optionally, the motor is a DC motor, such as a brushless stepper motor, which has the advantages of high speed and low noise and can operate stably and efficiently. The reducer is a high-precision planetary reducer, which can adapt to the use requirements in different situations. The transmission mechanism includes a ball screw nut pair, and the ball screw nut pair is, for example, a ball screw nut pair. By cooperating the motor, the reducer, and the transmission mechanism, the power mechanism 600 can have the characteristics of low output speed and high output torque, while achieving the purpose of accurately perfusing and drawing back the filling liquid, and can also reduce the volume and weight of the power mechanism 600.

[0094] In a typical embodiment, the motor is a brushless stepper motor with a rated speed of 5 r / min - 60 r / min, a torque of 2 N·m - 10 N·m, a number of steps of 2000 steps - 20000 steps, and a driving frequency of 15000 Hz - 25000 Hz. The rotational accuracy of the brushless stepper motor is 1.8°. The perfusion and aspiration accuracy of the filling liquid by the liquid aspiration device 500 is 0.5 ml. When the reduction ratio of the reducer is 5:1, through the reduction of the reducer, the output speed of the power mechanism 600 is reduced to 1 r / min - 12 r / min, the torque is increased to 10 N·m - 50 N·m, and the rotational accuracy of the output end reaches 0.36°. At the same time, the perfusion and aspiration accuracy of the filling liquid by the liquid aspiration device 500 can reach 0.1 ml.

[0095] In addition, the pressure monitoring element 400, the liquid aspiration device 500, and the power mechanism 600 can be integrated into an intra-aortic balloon pump controller.

[0096] In addition, similar to the prior art, as Figure 1 and Figure 4 shown, the coronary sinus balloon counterpulsation catheter 10 further includes components such as a radiopaque ring 710, a marker band 720, and a catheter fixing clip 730. Among them, the radiopaque ring 710 is disposed on the outer peripheral surface of the distal end of the catheter body 100 and is located on the distal side of the balloon 200. The marker band 720 is disposed on the outer peripheral surface of the proximal tube section 110 of the catheter body 100. The catheter fixing member 730 is connected to the outer surface of the distal end of the connector 300. The functions of the radiopaque ring 710, the marker band 720, and the catheter fixing clip 730 are well known to those skilled in the art and will not be elaborated here.

[0097] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims

1. A coronary sinus balloon counterpulsation catheter, characterized in that, It includes a catheter body and a balloon. The catheter body is provided with a first channel and a second channel that extend axially through the catheter body and are isolated from each other. The first channel is eccentrically arranged with respect to the catheter body. The cross-section of the second channel includes a first contour line and a second contour line. The first contour line is at least a part of a first circle, and the second contour line is at least a part of a second circle. The first contour line is closer to the first channel than the second contour line, and the concave sides of the first contour line and the second contour line are both arranged towards the first channel. The balloon is hermetically connected to the outer peripheral surface of the distal end of the catheter body and communicates with the second channel. The width of the second channel at a specified position of the second circle satisfies the following relationship: In the formula, h represents the width of the second channel at the specified position of the second circle, D represents the diameter of the second circle, d represents the diameter of the first circle, e is the distance between the center of the first circle and the center of the second circle, and θ represents the included angle formed by a first straight line and a second straight line. The first straight line refers to the straight line passing through the centers of the first circle and the second circle, and the second straight line refers to the straight line passing through the specified position and the center of the second circle. The width of the second channel refers to the dimension of the second channel in the radial direction of the first circle.

2. The coronary sinus balloon counterpulsation catheter according to claim 1, characterized in that, The cross-section of the first channel is circular, and the first channel is coaxial with the first circle. The catheter body is coaxial with the second circle.

3. The coronary sinus balloon counterpulsation catheter according to claim 1, wherein, The balloon includes a proximal balloon segment and a distal balloon segment that are symmetrically arranged and directly connected. The outer diameter and inner diameter of the proximal balloon segment both increase in the proximal-to-distal direction, and the outer diameter and inner diameter of the distal balloon segment both decrease in the proximal-to-distal direction.

4. The coronary sinus balloon counterpulsation catheter according to claim 1 or 3, characterized in that, The balloon is configured to be elastic.

5. The coronary sinus balloon counterpulsation catheter according to claim 4, wherein, The material for preparing the balloon includes any one of silica gel, polyurethane, and polyether block polyamide.

6. The coronary sinus balloon counterpulsation catheter according to claim 1, wherein It further includes a liquid suction device and a power mechanism. The liquid suction device includes a housing and a piston. The housing has an inner cavity, and the housing is also provided with a connection hole communicating with the inner cavity. The liquid suction device is connected to the proximal end of the catheter body through the connection hole and communicates with the second channel. The piston is at least partially disposed in the channel, and the piston is also connected to the power mechanism. The power mechanism is used to drive the piston to reciprocate along the axial direction of the connection hole.

7. The coronary sinus balloon counterpulsation catheter according to claim 6, characterized in that, The power mechanism includes a motor, a reducer, and a transmission mechanism that are connected in sequence. The reduction ratio of the reducer is 10:1 to 1:1, and the transmission mechanism is connected to the piston.

8. The coronary sinus balloon counterpulsation catheter according to claim 7, characterized in that, The motor is a DC motor; and / or, the reducer is a planetary reducer.

9. The coronary sinus balloon counterpulsation catheter according to claim 1, characterized in that, The catheter body includes a proximal tube segment and a distal tube segment that are axially connected. The distal tube segment is configured to be able to bend at least at its proximal end. The balloon is hermetically connected to the outer peripheral surface of the distal tube segment. A circulation hole communicating with the first channel is also provided on the side wall of the distal tube segment, and the circulation hole is located on the distal side of the balloon.

10. The coronary sinus balloon counterpulsation catheter according to claim 9, characterized in that, When the catheter body bends, the angle formed by the axis of the distal tube segment and the axis of the proximal tube segment is less than or equal to 135°; and / or, The axial length of the distal pipe section is 15 mm to 50 mm.

11. The coronary sinus balloon counterpulsation catheter according to claim 1, wherein It further includes a pressure monitoring element, which is connected to the proximal end of the catheter body and is correspondingly arranged with the first channel and / or the second channel.

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