Guide catheter

Abstract

The guiding catheter comprises a handle and a hollow catheter body, and the catheter body comprises an extension section and a bent section; the bent section is subjected to pre-shaping treatment and comprises a balloon, a first arc-shaped fixed bent part, a second arc-shaped fixed bent part and a third arc-shaped fixed bent part, and the first fixed bent part, the second fixed bent part, the balloon and the third fixed bent part are sequentially connected from the near end to the far end; the bending direction of the second fixed bending part is opposite to the bending direction of the first fixed bending part and the bending direction of the third fixed bending part; the chord lengths of the first fixed bending part, the second fixed bending part and the third fixed bending part are sequentially reduced, and the bending radius of the first fixed bending part and the bending radius of the third fixed bending part are both larger than the bending radius of the second fixed bending part. The functions of guiding and blocking the coronary sinus ostium can be achieved through the hollow tube body and the balloon, the bent section can enable the bent shape of the bent section to be matched with a target part, the operation difficulty of a doctor is reduced as much as possible, and the doctor can conduct surgical operation conveniently.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a guiding catheter. Background Art

[0002] With the advancement of intracardiac electrophysiological testing and ablation, physicians have long recognized the inextricable relationship between the coronary sinus (CS) and various arrhythmias, primarily due to its unique anatomical location and histological structure. The coronary sinus is part of the myocardial blood circulation system, its primary function being to collect venous blood from the myocardium and drain it back to the right atrium. It is located at the back of the heart, between the left and right atria, and opens into the right atrium through the coronary sinus ostium.

[0003] During coronary sinus surgery, a long coronary sinus sheath must first be placed within the sinus for enhanced support. Although most long coronary sinus sheaths are pre-shaped, the sinus ostium varies greatly, making it difficult to locate using the sheath alone and potentially causing coronary vein dissection or perforation. Clinically, decapole or quadrupole mapping electrodes are often used for coronary sinus mapping. Some centers utilize an Amplatz coronary angiography catheter to locate the coronary sinus, and then the long coronary sinus sheath is advanced into the coronary vein along the electrodes or catheter.

[0004] Coronary sinus mapping electrodes were originally designed for electrophysiological mapping. While they can achieve a certain degree of shaping, most distal ends are soft and cannot maintain the desired curvature. This leads to repeated removal and shaping, increasing the risk of infection, radiation exposure, and prolonged surgery. In addition to locating the coronary sinus, they can also record intraluminal images of different parts of the coronary sinus for use in finding bypass sites. However, due to their more complex structure, their value and price far exceed those of guiding catheters, and their sole use for locating the coronary sinus can lead to a waste of social resources. Furthermore, the solid structure of the mapping electrode prevents the injection of contrast agents or the passage of a guide wire. After intubation, the imaging balloon catheter must be replaced to complete the imaging, which also prolongs the surgery.

[0005] However, the Amplatz angiography catheter or MP angiography catheter has poor plasticity in appearance and does not have a matching steel wire or inner sheath. Although its hollow structure has angiography function, it lacks a balloon occlusion, resulting in unclear imaging. It is often necessary to replace the catheter with the angiography balloon to complete the angiography, which cannot meet the usage requirements.

[0006] That is, the current guiding catheters are expensive, cannot deliver surgical instruments, and most do not have a blocking function. Moreover, the guiding catheters are difficult to operate, and the search for the coronary sinus depends on the doctor's experience and operating techniques, which is not convenient for the doctor to operate. Utility Model Content

[0007] Based on this, it is necessary to provide a guide catheter to address the current problems of high cost, inability to deliver surgical instruments, and high difficulty in operation. The guide catheter can guide and block the coronary sinus ostium, and at the same time, facilitate the delivery of the guide catheter to the target site and reduce the difficulty of operation for doctors. The guide catheter is low in cost and easy to promote and use.

[0008] A guiding catheter comprises a handle and a hollow tube body, wherein the tube body comprises an extension section and a curved section, wherein the proximal end of the extension section is disposed at the distal end of the handle, and the distal end of the extension section is connected to the proximal end of the curved section;

[0009] The curved section is pre-shaped and includes a balloon and an arc-shaped first fixed curved portion, a second fixed curved portion, and a third fixed curved portion, wherein the first fixed curved portion, the second fixed curved portion, the balloon, and the third fixed curved portion are sequentially connected from the proximal end to the distal end;

[0010] The bending direction of the second fixed curved portion is opposite to the bending direction of the first fixed curved portion and the bending direction of the third fixed curved portion;

[0011] The chord lengths of the first fixed curved portion, the second fixed curved portion, and the third fixed curved portion decrease in sequence, and the bending radii of the first fixed curved portion and the third fixed curved portion are both greater than the bending radius of the second fixed curved portion.

[0012] In one embodiment of the present application, a bending radius of the third fixed curved portion is greater than a bending radius of the first fixed curved portion.

[0013] In one embodiment of the present application, the bending section is made of shape memory material.

[0014] In one embodiment of the present application, the tube body has a delivery cavity and a filling cavity, the delivery cavity and the filling cavity are independent of each other and not connected, and extend from the proximal end to the distal end;

[0015] The distal end of the delivery cavity passes through the distal end of the tube body so that the delivery cavity can deliver the interventional device, and the distal end of the filling cavity passes through the inner side of the balloon so that the balloon can be inflated or deflated.

[0016] In one embodiment of the present application, the tube has at least one of the following features:

[0017] Item 1: The delivery cavity is located at the axis of the tube body, and the filling cavity is located on the side of the delivery cavity;

[0018] Second, the cross-sectional shape of the delivery cavity is circular;

[0019] Item 3, the cross-sectional shape of the filling cavity is circular or semicircular;

[0020] Item 4: The inner diameter of the delivery lumen is not less than 3Fr of the tube body;

[0021] Item 5: The inner diameter of the filling cavity is no greater than 2 French.

[0022] Item 6. The distal outer wall of the tube body is coated with a hydrophilic coating.

[0023] In one embodiment of the present application, the curved section further includes a connecting tube, the connecting tube is arranged between the second fixed curved portion and the third fixed curved portion, and the balloon is sleeved on the outside of the connecting tube;

[0024] The connecting tube has a filling hole, which radially penetrates the connecting tube to connect the filling cavity with the inner side of the balloon; and / or the outer diameter of the connecting tube decreases from the proximal end to the distal end, and transitionally connects the second fixed bend and the third fixed bend.

[0025] In one embodiment of the present application, the guiding catheter further includes a position-limiting pusher, which is disposed on the handle and connected to the filling chamber, and is used to control the filling speed of the balloon.

[0026] In one embodiment of the present application, the guiding catheter further includes a strain relief sleeve, and the strain relief sleeve is disposed between the handle and the tube body.

[0027] In one embodiment of the present application, the tube body further comprises a plurality of marking components, and the plurality of marking components are arranged on the outer wall of the tube body from the proximal end to the distal end;

[0028] The marking component is a marking coating, which is circumferentially coated on the outer wall of the tube body, and multiple marking coatings are distributed from the proximal end to the distal end, and there is a preset spacing between adjacent marking coatings, and / or the marking component is a developing ring, and multiple developing rings are spaced apart in the curved section.

[0029] In one embodiment of the present application, the tube body includes an inner tube, a braided layer, and an outer tube, and the outer tube, the braided layer, and the inner tube are nested one on another.

[0030] The braided layer is formed by braiding multiple wires, and the multiple wires are at least one of metal wires, resin fiber wires, carbon fiber wires and glass fiber wires, and / or the inner tube and the outer tube are made of thermoplastic resin or thermosetting resin.

[0031] After adopting the above technical solution, this application has at least the following technical effects:

[0032] In the guiding catheter of the present application, the curved section is pre-shaped so that the first, second, and third fixed curved sections of the curved section exhibit a multi-segment curved configuration, allowing the curved configuration of the curved section to adapt to the shape of the target site. This allows the curved section to be moved within the body to the target site, and the third fixed curved section to pass through the coronary sinus ostium and extend into the coronary sinus, allowing the distal end of the guiding catheter to be delivered into position. Subsequently, after the balloon is inflated, it can occlude the coronary sinus ostium. Furthermore, because the tube body is hollow, surgical instruments can be delivered through the hollow tube body.

[0033] In this way, the guiding catheter can achieve the functions of guiding and blocking the coronary sinus ostium through the hollow tube body and the balloon. At the same time, the setting of the first fixed bending portion, the second fixed bending portion and the third fixed bending portion can make the bending shape of the bending section adapt to the target part, thereby facilitating the delivery of the guiding catheter to the target part and reducing the operating difficulty of the doctor as much as possible, making it easier for the doctor to perform surgical operations. In addition, the guiding catheter has low cost and is easy to promote and use. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 Schematic diagram of the structure of a guiding catheter in one embodiment of the present application.

[0035] Figure 2 for Figure 1 A cutaway diagram of the guiding catheter is shown.

[0036] Figure 3 for Figure 2 A partial enlarged view of the guiding catheter at point A is shown.

[0037] Figure 4 for Figure 2 A schematic cross-sectional view of the tube body is shown.

[0038] Figure 5 for Figure 2 A cutaway perspective view of a guiding catheter is shown.

[0039] Figure 6 for Figure 5 A partial enlarged view of the guiding catheter at position B is shown.

[0040] Figure 7 for Figure 3 An exploded view of the guiding catheter is shown.

[0041] Among them: 10, guiding catheter; 100, tube body; 110, extension section; 120, curved section; 121, first fixed curved portion; 122, second fixed curved portion; 123, third fixed curved portion; 124, balloon; 125, connecting tube; 1251, filling hole; 130, developing ring; 140, marking coating; 150, delivery cavity; 160, filling cavity; 200, handle; 300, strain relief sleeve. DETAILED DESCRIPTION

[0042] To make the above-mentioned objects, features, and advantages of the present application more clearly understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. The following description sets forth many specific details to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the scope of the present application. Therefore, the present application is not limited to the specific embodiments disclosed below.

[0043] In the description of this application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing this application and simplifying the description, and does 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 cannot be understood as a limitation on this application.

[0044] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of technical features indicated. Therefore, a feature specified as "first" or "second" may explicitly or implicitly include at least one of such features. In the description of this application, if the term "plurality" appears, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0045] In this application, unless otherwise specified or limited, the terms "mounted," "connected," "connected," "fixed," etc., should be interpreted broadly. For example, these terms may refer to fixed connections, removable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediary; and internal communication between two components or interaction between two components, unless otherwise specified. Those skilled in the art will understand the specific meanings of these terms in this application based on the specific circumstances.

[0046] In this application, unless otherwise expressly specified or limited, if a first feature is described as being "above" or "below" a second feature, or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above," "above," and "above" the second feature may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is at a higher level than the second feature. The first feature being "below," "below," and "below" the second feature may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0047] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only embodiment.

[0048] At present, during surgical operations on the coronary sinus, the coronary sinus is often found by using a coronary sinus decapole or quadrupole mapping electrode. Some centers use the Amplatz coronary angiography catheter, and the surgeon delivers the coronary sinus sheath into the coronary vein along the electrode or catheter. However, the coronary sinus mapping electrode was originally designed for electrophysiological mapping, and its operation process is complicated, costly, and inconvenient for doctors to operate. The Amplatz angiography catheter or the MP angiography catheter has poor plasticity in shape and lacks a balloon occlusion, making it impossible to achieve effective occlusion of the coronary sinus. In other words, the current guiding catheters are expensive and cannot deliver surgical instruments. Most of them do not have a occlusion function. Moreover, the operation of the guiding catheter is difficult, and the search for the coronary sinus depends on the doctor's experience and operating techniques, which is inconvenient for doctors to operate.

[0049] See also Figure 1 and Figure 2 To this end, the present application provides a guiding catheter 10. Figure 1This is a structural diagram of a guiding catheter 10 in an embodiment of the present application. Figure 2 for Figure 1 The diagram shows a truncated schematic diagram of a guiding catheter 10. The distal end of the guiding catheter 10 can be inserted into the patient's body and delivered to the target site, thereby delivering a surgical instrument (not shown) to the target site for surgical operation to achieve the purpose of treatment.

[0050] In this embodiment, the target site is the right atrium. The distal end of the guiding catheter 10 can enter the right atrium and extend into the coronary sinus through the coronary sinus ostium, facilitating subsequent surgical manipulation of the coronary sinus and thereby achieving the purpose of coronary sinus treatment. Of course, in other embodiments of the present application, the guiding catheter 10 can also be delivered to other target sites, which will not be described in detail here.

[0051] The surgical instruments herein include, but are not limited to, mapping electrodes, ablation catheters, interventional guidewires, and the like, and may also be other instruments capable of performing surgical operations. After the distal end of the guiding catheter 10 enters the patient's body and extends into the coronary sinus, surgical instruments can be delivered through the guiding catheter 10 to perform surgery on the coronary sinus.

[0052] It is worth noting that the two opposite ends of the guiding catheter 10 are the proximal end and the distal end. The proximal end of the guiding catheter 10 is the end of the guiding catheter 10 close to the doctor, and the distal end of the guiding catheter 10 is the end of the guiding catheter 10 extending into the patient's body. Figure 1 As shown, the left side is the proximal end of the guiding catheter 10, and the right side is the distal end of the guiding catheter 10. The proximal and distal ends of the guiding catheter 10 also refer to the extension direction, axial direction, and length direction of the guiding catheter 10. The proximal and distal ends of the guiding catheter 10 are applicable to all components of the guiding catheter 10 and will not be described in detail below.

[0053] The guiding catheter 10 can guide and occlude the coronary sinus ostium, and at the same time, facilitates delivery of the guiding catheter 10 to the target site, reduces the difficulty of operation for the doctor, and is low-cost and easy to promote. The specific structure of the guiding catheter 10 according to one embodiment is described below.

[0054] See also Figures 1 to 3In one embodiment, the guiding catheter 10 includes a handle 200 and a hollow tubular body 100. The tubular body 100 includes an extension section 110 and a curved section 120. The proximal end of the extension section 110 is disposed at the distal end of the handle 200, and the distal end of the extension section 110 is connected to the proximal end of the curved section 120. The curved section 120 is pre-molded and includes a balloon 124 and an arc-shaped fixed curved portion 121, a second fixed curved portion 122, and a third fixed curved portion 123. The first fixed curved portion 121, the second fixed curved portion 122, the balloon 124, and the third fixed curved portion 123 are sequentially connected from the proximal end to the distal end. The curvature of the second fixed curved portion 122 is opposite to the curvature of the first fixed curved portion 121 and the curvature of the third fixed curved portion 123. The chord lengths of the first fixed curved portion 121 , the second fixed curved portion 122 and the third fixed curved portion 123 decrease in sequence. The bending radius of the first fixed curved portion 121 and the third fixed curved portion 123 are greater than the bending radius of the second fixed curved portion 122 . Figure 3 for Figure 2 The illustrated portion is an enlarged view of the guide catheter 10 at point A.

[0055] The handle 200 is the operating portion of the guiding catheter 10, while the body 100 is the component that performs the guiding function. The proximal end of the body 100 is located at the distal end of the handle 200. During the actual surgical procedure, the surgeon grasps and manipulates the handle 200 to move the distal end of the body 100 within the patient's body, entering the right atrium and extending into the coronary sinus through the coronary sinus ostium. The distal end of the body 100 is fixed to the coronary sinus, preventing it from moving within the patient's body and ensuring that the distal end of the body 100 reaches the designated position.

[0056] Furthermore, the tube body 100 is hollow, that is, the tube body 100 has a hollow cavity that extends from the proximal end to the distal end of the tube body 100. When the distal end of the tube body 100 enters the coronary sinus, surgical instruments can enter the patient's body through the hollow tube body 100 and ultimately be delivered to the coronary sinus, where surgical operations can be performed on the coronary sinus.

[0057] Specifically, the guiding catheter 10 of the present application serves as a sheath-like device during surgery, guiding other surgical instruments, such as an ablation catheter, into the target tissue (i.e., the coronary sinus in the present application). Therefore, the present application utilizes a hollow tubular body 100 as the main body of the guiding catheter 10. The hollow cavity of the tubular body 100 provides a lumen of sufficient size for the passage of surgical instruments, thereby achieving the purpose of delivering the surgical instruments.

[0058] Specifically, the proximal end of the extension section 110 is connected to the handle 200, and the distal end of the extension section 110 is connected to the proximal end of the curved section 120. The distal end of the curved section 120 extends away from the handle 200. Thus, the extension section 110 and the curved section 120 are connected to form a hollow tubular body 100. The extension section 110 extends along the proximal and distal ends of the guiding catheter 10, that is, the extension section 110 is a long straight section. This extension section 110 increases the length of the guiding catheter 10, thereby ensuring sufficient control distance during surgery. At the same time, the extension section 110 also provides sufficient support for the curved section 120.

[0059] During surgery, curved segment 120 can locate the target site. More specifically, it can locate and guide the coronary sinus within the right atrium. Curved segment 120 is pre-shaped to provide a curved shape that matches the target site (hereinafter referred to as the right atrium).

[0060] After pre-shaping (typically heat treatment), curved segment 120 acquires a fixed curvature that adapts to the shape of the right atrium. Once extended into the right atrium, curved segment 120 abuts against the right atrium due to its curved shape. At this point, rotating handle 200 adjusts the orientation of curved segment 120 so that its distal end passes through the coronary sinus ostium and into the coronary sinus.

[0061] After the bend section 120 is pre-shaped, the guiding catheter 10 forms a fixed-bend catheter. Unlike bend-adjustable catheters, the guiding catheter 10 of the present application does not require a corresponding bend-adjusting structure within the handle 200. This reduces the structural complexity of the guiding catheter 10, thereby reducing its operational difficulty and also lowering its production cost. Based on actual comparisons, the cost of the guiding catheter 10 of the present application can be reduced to 1 / 2 to 1 / 5 of that of a bend-adjustable catheter. This lower cost facilitates its widespread application.

[0062] Specifically, the curved section 120 includes a first fixed curved portion 121, a second fixed curved portion 122, a balloon 124, and a third fixed curved portion 123. The proximal end of the first fixed curved portion 121 is connected to the distal end of the extension section 110, the distal end of the first fixed curved portion 121 is connected to the proximal end of the second fixed curved portion 122, the distal end of the second fixed curved portion 122 is connected to the proximal end of the balloon 124, the distal end of the balloon 124 is connected to the proximal end of the third fixed curved portion 123, and the distal end of the third fixed curved portion 123 extends away from the handle 200. Thus, the first fixed curved portion 121, the second fixed curved portion 122, the balloon 124, and the third fixed curved portion 123 are sequentially arranged and connected from proximal to distal to form the curved section 120.

[0063] Moreover, the first fixed bend 121, the second fixed bend 122 and the third fixed bend 123 are all arranged in an arc shape, the bending direction of the first fixed bend 121 is opposite to the bending direction of the second fixed bend 122, and the bending direction of the second fixed bend 122 is opposite to the bending direction of the third fixed bend 123. The chord lengths of the first fixed bend 121, the second fixed bend 122 and the third fixed bend 123 decrease successively, and the bending radius of the first fixed bend 121 and the third fixed bend 123 is greater than the bending radius of the second fixed bend 122.

[0064] Thus, the curved section 120 has a three-section curved configuration through the first fixed curved portion 121, the second fixed curved portion 122, and the third fixed curved portion 123, which better adapts to the structure of the right atrium and facilitates finding the coronary sinus ostium. Furthermore, the curved section 120 abuts the bottom of the right atrium through the first fixed curved portion 121, abuts the upper right side of the right atrium through the second fixed curved portion 122, and finds and extends into the coronary sinus ostium through the third fixed curved portion 123.

[0065] After the guiding catheter 10 of the present application delivers the curved section 120 to the right atrium, the curved section 120 can abut against the right atrium through the first fixed curved portion 121, the second fixed curved portion 122 and the third fixed curved portion 123, thereby realizing the positioning of the curved section 120 in the right atrium, which is convenient for the doctor's operation. At the same time, the doctor can turn the handle 200 to find the coronary sinus opening through the third fixed curved portion 123 at the distal end of the curved section 120, so that the search for the coronary sinus opening does not rely on the doctor's experience and operation, thereby reducing the doctor's operation difficulty as much as possible and facilitating the doctor's surgical operation.

[0066] Balloon 124 has an expanded configuration and a contracted configuration and can switch between the expanded and contracted configurations. When tube body 100 is delivered to the patient, balloon 124 is in the contracted configuration. When balloon 124 is filled, it gradually expands from the contracted configuration to the expanded configuration, at which point the volume of balloon 124 increases. Optionally, balloon 124 is filled with gas or liquid to enable expansion. When the catheter needs to be withdrawn, balloon 124 is deflated to deflate it from the expanded configuration to the contracted configuration.

[0067] After gas or liquid is introduced into the balloon 124, the balloon 124 is expanded to an expanded configuration. At this time, the balloon 124 can block part of the human body tissue, such as the coronary sinus or vein, etc. Of course, in other embodiments of the present application, the balloon 124 can also be used to expand the narrow part of the blood vessel.

[0068] After the balloon 124 is disposed in the curved section 120 of the guiding catheter 10 of the present application, the balloon 124 can occlude the coronary sinus ostium, thereby achieving the purpose of occluding the coronary sinus. Furthermore, the balloon 124 can secure the curved section 120 within the coronary sinus, thereby fixing the position of the curved section 120 within the coronary sinus and thereby determining the guiding position of the guiding catheter 10.

[0069] During the actual surgical procedure, the distal end of the guiding catheter 10 enters the patient's body through a venous pathway established by the clavicle and enters the right atrium along the superior vena cava. After the curved section 120 enters the right atrium, due to its shape memory function, it maintains a fixed curved configuration within the right atrium. As the guiding catheter 10 continues to advance, the configuration of the first fixed curved section 121 is displayed on the imaging device.

[0070] At this point, the first fixed curved portion 121 abuts the bottom of the right atrium, and the slightly inward extending section 110 is positioned slightly to the left in the image displayed on the display device, while the second fixed curved portion 122 abuts the upper right side of the right atrium. Thus, the first fixed curved portion 121 and the second fixed curved portion 122 have a certain position-limiting and fixing function in the right atrium.

[0071] Horizontally, the coronary sinus ostium is now located between the lowest point of the first fixed curved portion 121 and the highest point of the second fixed curved portion 122, that is, within the range of the third fixed curved portion 123. At this point, the handle 200 is rotated, and the handle 200 drives the third fixed curved portion 123 to rotate via the curved section 120, causing the distal end of the third fixed curved portion 123 to swing, thereby finding the coronary sinus ostium.

[0072] After finding the coronary sinus ostium, the distal end of the tube 100 is inserted into the coronary sinus from the ostium. Then, the balloon 124 is inflated until it is in an expanded configuration. At this point, the balloon 124 is secured in the coronary sinus, blocking the ostium and securing the guiding position of the guide catheter 10. At this point, surgical instruments can be delivered through the hollow tube 100 to perform surgery on the coronary sinus.

[0073] The guiding catheter 10 of the above embodiment can achieve the functions of guiding and blocking the coronary sinus ostium through the hollow tube body 100 and the balloon 124. At the same time, the setting of the first fixed curved portion 121, the second fixed curved portion 122 and the third fixed curved portion 123 can make the curved shape of the curved section 120 adapt to the target site, thereby facilitating the delivery of the guiding catheter 10 to the target site and reducing the operating difficulty of the doctor as much as possible, making it easier for the doctor to perform surgical operations. In addition, the guiding catheter 10 has low cost and is easy to promote and use.

[0074] In one embodiment, the extension section 110 and the curved section 120 are integrally formed. This ensures structural strength at the junction of the extension section 110 and the curved section 120 while facilitating the molding process of the tube body 100. Optionally, the extension section 110 is a uniform outer diameter tube. In other words, the outer diameter of the extension section 110 is the same from the proximal end to the distal end.

[0075] In one embodiment, a hydrophilic coating is applied to the outer wall of the distal end of the tube body 100. The hydrophilic coating can increase the lubricity of the distal end of the tube body 100, reduce the resistance of the distal end of the tube body 100 to movement within the patient's body, and facilitate the movement of the distal end of the tube body 100 within the patient's body, thereby reducing the difficulty of the surgery.

[0076] In one embodiment, the curved section 120 is made of a shape-memory material. In other words, the curved section 120 exhibits shape-memory properties. After the pre-molding process, the curved section 120 assumes a fixed curved shape. When the distal end of the tube 100 is inserted into the patient's body, the curved section 120 deforms slightly to deviate from the previously fixed curved shape, facilitating the distal end of the tube 100's entry into the patient's body.

[0077] Because curved segment 120 has shape memory, once the distal end of tube body 100 enters the right atrium, curved segment 120 is no longer subject to forces from blood vessels or other body cavities and can resume its previously fixed curved configuration, allowing it to abut the right atrium. Optionally, curved segment 120 is made of a shape memory alloy, so that the pre-shaped curved segment 120 has shape memory.

[0078] In the present application, the bending direction, chord length, and bending radius of the first fixed curved portion 121, the second fixed curved portion 122, and the third fixed curved portion 123 are set according to the shape of the right atrial cavity, so that the curved segment 120 presents a fixed curved shape to adapt to the shape of the right atrial cavity, facilitating the distal end of the guide catheter 10 to be inserted into the coronary sinus. Of course, in other embodiments of the present application, the curved segment 120 may also include another number of fixed curved portions. After the fixed curved portions are connected and formed in the above-mentioned direction, they have a multi-stage curved shape to facilitate the delivery of the distal fixed curved portion into the coronary sinus.

[0079] In one embodiment, the curvature radius of the third fixed curved portion 123 is greater than that of the first fixed curved portion 121. In other words, the curvature radii of the third fixed curved portion 123, the first fixed curved portion 121, and the second fixed curved portion 122 decrease in order. This allows the coronary sinus ostium to be located within the range of the third fixed curved portion 123 after the curved segment 120 is secured to the right atrium. At this point, rotating the handle 200 allows the third fixed curved portion 123 to pass through the coronary sinus ostium and into the coronary sinus.

[0080] See also Figures 1 to 4 In one embodiment, the tube body 100 has a delivery lumen 150 and a filling lumen 160. The delivery lumen 150 and the filling lumen 160 are independent of each other and not connected, and extend from the proximal end to the distal end. The distal end of the delivery lumen 150 passes through the distal end of the tube body 100 so that the delivery lumen 150 can deliver the interventional device, and the distal end of the filling lumen 160 passes through the inner side of the balloon 124 so that the balloon 124 can be inflated or deflated. Figure 4 for Figure 2 FIG. 1 is a schematic cross-sectional view of the tube body 100 shown in FIG.

[0081] The tubing 100 is a two-lumen tube having two hollow cavities: a delivery lumen 150 and a filling lumen 160. The delivery lumen 150 extends in a proximal-distal direction and passes through both ends of the tubing 100. The filling lumen 160 also extends in a proximal-distal direction, with the proximal end of the filling lumen 160 passing through the proximal end of the tubing 100 and the distal end of the filling lumen 160 extending radially through the tubing 100 and communicating with the balloon 124.

[0082] Thus, filling chamber 160 is used to deliver a filling gas or liquid. When the coronary sinus ostium needs to be blocked, the filling gas or liquid is delivered to balloon 124 through filling chamber 160, causing balloon 124 to expand to an expanded configuration to block the coronary sinus ostium. After the procedure is completed and guiding catheter 10 needs to be withdrawn, the gas or liquid in balloon 124 is withdrawn through filling chamber 160, causing balloon 124 to deflate to a collapsed configuration. At this point, balloon 124 can be withdrawn from the patient's body along with the catheter without scratching human tissue.

[0083] Delivery lumen 150 is used to deliver surgical instruments. Once the guiding catheter 10 has been positioned, the surgical instruments can be delivered to the coronary sinus via delivery lumen 150, where they can be used to perform surgical procedures on the coronary sinus, achieving the goal of treating the coronary sinus. Furthermore, delivery lumen 150 and filling lumen 160 are independent and disconnected, ensuring that balloon 124 remains fully filled and preventing gas or liquid from entering the patient's body through delivery lumen 150.

[0084] See also Figure 4 In one embodiment, the delivery lumen 150 is located at the axis of the tubular body 100, and the filling lumen 160 is located on the side of the delivery lumen 150. In other words, the delivery lumen 150 is located in the middle region of the cross section of the tubular body 100, and the filling lumen 160 is arranged at the edge of the cross section of the tubular body 100, so that the filling lumen 160 is located on the side of the delivery lumen 150. This facilitates the delivery of surgical instruments while not affecting the inflation of the balloon 124.

[0085] See also Figure 4 In one embodiment, the delivery cavity 150 has a circular cross-section. This allows for a smooth inner wall of the delivery cavity 150, preventing interference between the inner wall of the delivery cavity 150 and the surgical instrument, ensuring stability during delivery of the surgical instrument through the delivery cavity 150 and facilitating surgical procedures. Furthermore, the circular cross-section of the delivery cavity 150 facilitates machining and molding.

[0086] See also Figure 4 In one embodiment, the cross-sectional shape of the filling cavity 160 is semicircular, and the flow of the filling gas or liquid is achieved through the semicircular filling cavity 160. Of course, in other embodiments of the present application, the cross-sectional shape of the filling cavity 160 can also be circular, polygonal, or other regular or irregular shapes, as long as the filling gas or liquid can pass through.

[0087] In one embodiment, the inner diameter of delivery lumen 150 is no less than 3 Fr. In other words, tube body 100 is capable of delivering surgical instruments with a diameter of at least 3 Fr. Thus, guiding catheter 10 possesses a minimum inner diameter, enabling the delivery of various types of surgical instruments. It is worth noting that Fr is a unit of measurement for catheters, a well-known concept that will not be discussed further below.

[0088] In one embodiment, the inner diameter of the filling lumen 160 is no greater than 2 Fr. Thus, the filling lumen 160 has a sufficient size to deliver gas or liquid to inflate the balloon 124 while not taking up too much of the size of the tube body 100.

[0089] See also Figure 2 、 Figures 5 to 7In one embodiment, the curved section 120 further includes a connecting tube 125 , which is disposed between the second fixed curved portion 122 and the third fixed curved portion 123 , and the balloon 124 is sleeved on the outside of the connecting tube 125 . Figure 5 for Figure 2 A truncated perspective view of the guide catheter 10 is shown. Figure 6 for Figure 5 The partial enlarged view of the guiding catheter 10 at B is shown. Figure 7 for Figure 3 An exploded schematic diagram of the guiding catheter 10 is shown.

[0090] exist Figure 7 In the embodiment, the proximal end of the connecting tube 125 is connected to the distal end of the second fixed curved portion 122, and the distal end of the connecting tube 125 is connected to the proximal end of the third fixed curved portion 123. The connecting tube 125 enables the installation of the balloon 124, which is sleeved outside the connecting tube 125 to be installed between the second fixed curved portion 122 and the third fixed curved portion 123. Furthermore, the balloon 124 is sealedly connected to the second fixed curved portion 122 and the third fixed curved portion 123 to ensure the sealing of the balloon 124.

[0091] See also Figure 6 and Figure 7 In one embodiment, the connecting tube 125 has a filling hole 1251 that radially extends through the connecting tube 125 to connect the filling cavity 160 with the inner side of the balloon 124. The filling hole 1251 radially extends through the connecting tube 125 relative to the tubular body 100, thereby connecting the filling cavity 160 with the balloon 124. When the balloon 124 is inflated, gas or liquid can pass through the filling cavity 160 and enter the balloon 124 through the filling hole 1251, thereby expanding the balloon 124 to an inflated configuration. When the balloon 124 is deflated, the gas or liquid in the balloon 124 enters the filling cavity 160 through the filling hole 1251, thereby defusing the balloon 124 to a deflated configuration.

[0092] It is worth noting that the filling hole 1251 is not limited in principle, as long as it can connect the filling cavity 160 with the balloon 124. In this embodiment, the filling hole 1251 is cut to form an eagle-beak-shaped incision. Since the filling cavity 160 is located on the side of the delivery cavity 150, after the filling hole 1251 is cut, the filling cavity 160 reveals an opening at the distal end of the tube body 100 for filling the balloon 124.

[0093] Furthermore, the filling hole 1251 is formed by beveling, so that the filling hole 1251 has a certain slope to guide the flow of gas or liquid and ensure the stability of the flow of gas or liquid in the balloon 124. Of course, in other embodiments of the present application, the filling hole 1251 can also have a certain angle along the axial direction, extend along the radial direction, etc.

[0094] See also Figure 6 and Figure 7 In one embodiment, the outer diameter of the connecting tube 125 decreases from the proximal end to the distal end, transitioning between the second fixed curved portion 122 and the third fixed curved portion 123. In other words, the outer diameter of the second fixed curved portion 122 is larger than that of the third fixed curved portion 123. The outer diameter of the connecting tube 125 is generally tapered, and the connecting tube 125 transitions between the second fixed curved portion 122 and the third fixed curved portion 123, facilitating the connection between the second fixed curved portion 122 and the third fixed curved portion 123.

[0095] In one embodiment, the balloon 124 is fixed to the distal end of the tube body 100 by gluing or welding. That is, the proximal end of the balloon 124 is fixed to the second fixed curved portion 122 by gluing or welding, and the distal end of the balloon 124 is fixed to the third fixed curved portion 123 by gluing or welding, so that the balloon 124 has a closed structure, which facilitates the switching of the balloon 124 between the expanded and deflated configurations.

[0096] In one embodiment, balloon 124 is made of a compliant balloon material such as silicone, thermoplastic elastomer (TPE), or latex. This prevents damage to human tissue and provides a certain degree of flexibility, reducing the risk of dissection. Of course, in other embodiments of the present application, balloon 124 may also be made of a non-compliant balloon material such as nylon, a semi-compliant balloon material, or a super-compliant balloon material.

[0097] In one embodiment, after balloon 124 is inflated, the standard diameter range of balloon 124 is 0.75 mm to 28 mm, and the length of balloon 124 from proximal to distal ends ranges from 3 mm to 25 mm. Preferably, after balloon 124 is inflated, the standard diameters of balloon 124 are 11 mm, 13 mm, and 15 mm. Thus, when balloon 124 is in the expanded configuration, the three sizes of balloon 124 can meet the needs of different patients for occluding the coronary sinus ostia, thereby meeting the actual surgical requirements.

[0098] In one embodiment, the guiding catheter 10 further includes a stopper pusher (not shown), which is disposed on the handle 200 and communicates with the filling chamber 160. The stopper pusher is used to control the filling speed of the balloon 124. During the filling of the balloon 124, the stopper pusher can control the filling speed and pressure of the balloon 124, preventing the injection of the filling gas or liquid at too high a speed or pressure, thereby ensuring smooth expansion of the balloon 124 and reducing the risk of dissection.

[0099] See also Figure 2 、 Figure 3 、 Figure 6 and Figure 7 In one embodiment, the tube body 100 further includes a plurality of marking components disposed on the outer wall of the tube body 100 from the proximal end to the distal end. After the curved section 120 enters the patient's body, the position of the marking components can be displayed in the image displayed by imaging equipment (such as CT, DSA, X-ray equipment, etc.). The marking components can then be used to determine the position of the curved section 120 within the patient's body and the length of the curved section 120 that has entered the patient's body, making it easier for the doctor to observe the distal end of the tube body 100 entering the patient's body.

[0100] See also Figure 2 、 Figure 3 、 Figure 6 and Figure 7 In one embodiment, the marking component is a marking coating 140, which is circumferentially coated on the outer wall of the tubular body 100. Multiple marking coatings 140 are distributed from the proximal end to the distal end, with a predetermined spacing between adjacent marking coatings 140. The marking coating 140 can mark the length of the tubular body 100 that extends into the patient's body.

[0101] That is to say, the marking coating 140 is coated on the outer wall of the tube body 100, and there is a certain distance between two adjacent marking coatings 140. The marking coating 140 cooperates with the developing equipment to locate the length of the tube body 100 extending into the patient's body, and at the same time, it can also reduce costs.

[0102] Optionally, the interval between two adjacent marking coatings 140 is 10 cm. Of course, in other embodiments of the present application, the interval between two adjacent marking coatings 140 can also be other sizes, as long as it is convenient for doctors to identify under the illumination of the display device.

[0103] See also Figure 2 、 Figure 3 、 Figure 6 and Figure 7 In one embodiment, the marking member is a developing ring 130, and a plurality of developing rings 130 are disposed at intervals on the curved section 120. The developing rings 130 are also disposed at the distal end of the tube 100 and can display the position of the curved section 120 in the patient's body under the illumination of a developing device.

[0104] Optionally, the developing ring 130 is made of platinum-iridium alloy, tantalum alloy, etc. The developing ring 130 can make the image display clearer under the illumination of the developing device, which is convenient for doctors to identify.

[0105] In this embodiment, there are six developing rings 130, which are respectively located at: the connection between the extension section 110 and the first fixed bend 121, the middle section of the first fixed bend 121, the connection between the first fixed bend 121 and the second fixed bend 122, the connection between the second fixed bend 122 and the balloon 124, the middle area of ​​the balloon 124 and the distal end of the third fixed bend 123.

[0106] Thus, the six developing rings 130 can be used together to clearly display the positional relationship between the first fixed curved portion 121, the second fixed curved portion 122, the third fixed curved portion 123, and the balloon 124 in the curved segment 120 in the imaging device, thereby facilitating the surgeon's determination of the position of the curved segment 120 and facilitating surgical procedures. Of course, in other embodiments of the present application, the number of developing rings 130 can be other, as long as the curved segment 120 can be reliably positioned.

[0107] See also Figure 2 、 Figure 3 、 Figure 6 and Figure 7 In this embodiment, the tube body 100 is marked using a combination of multiple marking coatings 140 and multiple developing rings 130. As will be appreciated, the marking coatings 140 are relatively inexpensive, while the developing rings 130 are relatively expensive. The combination of the marking coatings 140 and developing rings 130 for marking and positioning the distal end of the tube body 100 allows for accurate positioning and a clearer image display.

[0108] When the distal end of the guiding catheter 10 enters the patient's body, under the illumination of the developing device, due to the combined effect of the marking coating 140 and the developing ring 130, the three-dimensional development of the distal end of the guiding catheter 10 and the bending shape of the bending section 120 can be clearly displayed in the image, marking the bending state of the distal end of the guiding catheter 10 in the body.

[0109] See also Figure 1 and Figure 2 In one embodiment, the guiding catheter 10 further includes a strain relief sleeve 300, which is disposed between the handle 200 and the tube body 100. In other words, the distal end of the strain relief sleeve 300 is connected to the proximal end of the tube body 100, and the proximal end of the strain relief sleeve 300 is disposed on the handle 200, thereby achieving the connection between the tube body 100 and the handle 200.

[0110] The strain relief sleeve 300 can tighten the connection between the handle 200 and the tube body 100, thereby improving the reliability of the connection between the handle 200 and the tube body 100 and preventing the handle 200 and the tube body 100 from separating during actual surgery. Furthermore, the strain relief sleeve 300 can provide a certain amount of torque to prevent excessive twisting of the tube body 100 during rotation of the guiding catheter 10, thereby improving the bending performance of the tube body 100.

[0111] In one embodiment, the tube body 100 includes an inner tube, a braided layer, and an outer tube, wherein the outer tube, the braided layer, and the inner tube are nested one above the other. In other words, the braided layer is disposed within the tube wall of the tube body 100 and is disposed between the inner and outer tubes. The braided layer supports the tube body 100 and increases its rigidity.

[0112] In one embodiment, the braided layer is formed by braiding multiple wires. The braided layer is formed by weaving multiple wires into a tubular structure with gaps between them. The tubular structure of the braided layer can be wound horizontally in the same direction, or while changing the winding direction, such as clockwise or counterclockwise. The winding pitch, grid spacing, and inclination angle relative to the circumferential direction can also be changed according to the position. The structure is not particularly limited.

[0113] Optionally, the plurality of wires are at least one of stainless steel, platinum (Pt) / tungsten (W) or other metal wires, resin fiber wires, carbon fiber wires, and glass fiber wires. It is worth noting that the wire diameter is not particularly limited. Optionally, the wire diameter ranges from 0.04 to 0.05 mm. The cross-sectional shape of the wire is also not particularly limited, and may be, for example, circular, elliptical, or rectangular.

[0114] In one embodiment, the inner and outer tubes are made of thermoplastic resin or thermosetting resin. The inner and outer tubes of tube body 100 can be made of thermoplastic resin or thermosetting resin, among others. Preferably, the inner and outer tubes of tube body 100 are made of a low-friction material such as a fluororesin such as polytetrafluoroethylene (PTFE) or high-density polyethylene (HDPE). Of course, the inner tube of tube body 100 can also be made of various thermoplastic elastomers, such as polyurethane, polyester, polyamide, polybutadiene, trans-polyisoprene, fluororubber, or chlorinated polyethylene. Any one of these or a combination of two or more (polymer alloys, polymer blends, laminates, etc.) can also be used.

[0115] The guiding catheter 10 of the present application can achieve the functions of guiding and blocking the coronary sinus ostium through the hollow tube body 100 and the balloon 124. At the same time, the curved section 120 has a three-section curved shape through the first fixed curved portion 121, the second fixed curved portion 122 and the third fixed curved portion 123, so as to better adapt to the structure of the right atrium, facilitate finding the coronary sinus ostium, facilitate delivering the guiding catheter 10 to the target site, and reduce the doctor's operating difficulty as much as possible, making it easier for the doctor to perform surgical operations. The guiding catheter 10 has low cost and is easy to promote and use.

[0116] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0117] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and these modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A guiding catheter, characterized in that: The device comprises a handle and a hollow tube body, wherein the tube body comprises an extension section and a curved section, wherein the proximal end of the extension section is arranged at the distal end of the handle, and the distal end of the extension section is connected to the proximal end of the curved section; The curved section is pre-shaped and includes a balloon and an arc-shaped first fixed curved portion, a second fixed curved portion, and a third fixed curved portion, wherein the first fixed curved portion, the second fixed curved portion, the balloon, and the third fixed curved portion are sequentially connected from the proximal end to the distal end; The bending direction of the second fixed curved portion is opposite to the bending direction of the first fixed curved portion and the bending direction of the third fixed curved portion; The chord lengths of the first fixed curved portion, the second fixed curved portion, and the third fixed curved portion decrease in sequence, and the bending radii of the first fixed curved portion and the third fixed curved portion are both greater than the bending radius of the second fixed curved portion.

2. The guiding catheter according to claim 1, wherein: The bending radius of the third fixed curved portion is greater than the bending radius of the first fixed curved portion.

3. The guiding catheter according to claim 1, wherein: The bending section is made of shape memory material.

4. The guiding catheter according to any one of claims 1 to 3, characterized in that: The tube body has a delivery cavity and a filling cavity, the delivery cavity and the filling cavity are independent of each other and not connected, and extend from the proximal end to the distal end; The distal end of the delivery cavity passes through the distal end of the tube body so that the delivery cavity can deliver the interventional device, and the distal end of the filling cavity passes through the inner side of the balloon so that the balloon can be inflated or deflated.

5. The guiding catheter according to claim 4, wherein: The tube body has at least one of the following characteristics: Item 1: The delivery cavity is located at the axis of the tube body, and the filling cavity is located on the side of the delivery cavity; Second, the cross-sectional shape of the delivery cavity is circular; Item 3, the cross-sectional shape of the filling cavity is circular or semicircular; Item 4: The inner diameter of the delivery lumen is not less than 3Fr of the tube body; Item 5: The inner diameter of the filling cavity is no greater than 2 French. Item 6. The distal outer wall of the tube body is coated with a hydrophilic coating.

6. The guiding catheter according to claim 4, characterized in that The curved section further includes a connecting tube, which is arranged between the second fixed curved portion and the third fixed curved portion, and the balloon is sleeved on the outside of the connecting tube; The connecting tube has a filling hole, which radially penetrates the connecting tube to connect the filling cavity with the inner side of the balloon; and / or the outer diameter of the connecting tube decreases from the proximal end to the distal end, and transitionally connects the second fixed bend and the third fixed bend.

7. The guiding catheter according to claim 4, wherein: The guiding catheter further includes a position limiting injector, which is disposed on the handle and communicates with the filling cavity. The position limiting injector is used to control the filling speed of the balloon.

8. The guiding catheter according to any one of claims 1 to 3, characterized in that: The guiding catheter further includes a strain relief sleeve disposed between the handle and the tube body.

9. The guiding catheter according to any one of claims 1 to 3, characterized in that: The tube body further comprises a plurality of marking components, and the plurality of marking components are arranged on the outer wall of the tube body from the proximal end to the distal end; The marking component is a marking coating, which is circumferentially coated on the outer wall of the tube body, and multiple marking coatings are distributed from the proximal end to the distal end, and there is a preset spacing between adjacent marking coatings, and / or the marking component is a developing ring, and multiple developing rings are spaced apart in the curved section.

10. The guiding catheter according to any one of claims 1 to 3, characterized in that: The tube body comprises an inner tube, a braided layer and an outer tube, wherein the outer tube, the braided layer and the inner tube are arranged in layers; The braided layer is formed by braiding multiple wires, and the multiple wires are at least one of metal wires, resin fiber wires, carbon fiber wires and glass fiber wires, and / or the inner tube and the outer tube are made of thermoplastic resin or thermosetting resin.

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