Catheter system

Abstract

The utility model relates to a catheter system, a supporting channel with two through ends is arranged in a supporting catheter, a first axial positioning structure is arranged on the supporting catheter, a balloon catheter is configured to be movably arranged in the supporting channel in a penetrating mode, and the first axial positioning structure can be used for determining the relative position of the supporting catheter and the balloon catheter. The dilator is configured to be movably arranged in the supporting channel in a penetrating mode, and the first axial positioning structure can be used for determining the relative position of the supporting catheter and the dilator. According to the catheter system, the dilator, the balloon catheter and the supporting catheter are seamlessly matched, so that the variable supporting strength of the dilator is achieved, the variable balloon body length of the balloon catheter is achieved, and the catheter system is closer to clinical requirements. The expandable length of the balloon body can be controlled and adjusted by matching with the supporting catheter, so that effective expansion can be realized, and vascular injury caused by excessive expansion of the blood vessel can be reduced. The dilator is matched with the supporting catheter, so that adjustable supporting performance can be realized, and the passing ability can be improved.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a catheter system. Background Art

[0002] Interventional therapy has many advantages such as less bleeding, less trauma, fewer complications, rapid postoperative recovery, safety and reliability, etc., which can greatly reduce the pain suffered by patients.

[0003] Dilation catheter therapy is repeatable. When vascular restenosis occurs, it can be dilated again through a minimally invasive method. However, the lesions of lower limb ischemia are prone to calcification and the lesion sites are relatively long. During lower limb interventional therapy surgery, the existing dilation catheters have poor pushing performance and low pressure resistance strength, and cannot pass through calcified lesions and long-segment occluded blood vessels, resulting in the inability to successfully complete relevant surgeries and relieve the pain of patients and improve the quality of life of patients.

[0004] The dog bone effect refers to the situation where when the stent delivery system is filled to the maximum recommended filling pressure, the diameters of both the proximal end and the distal end of the balloon are larger than the diameters of the proximal end and the distal end of the stent. At this time, it looks quite like a dog bone under X-ray, so it is called the dog bone effect. This phenomenon is not desired clinically because the bulging ends of the balloon will cause unnecessary damage to the blood vessels. Therefore, it should be restricted when filled to the maximum recommended filling pressure. The length of the balloon carried by the existing dilation catheter is fixed and cannot be adjusted according to the lesion length. Different balloon catheters need to be replaced, increasing the surgical cost and time. The extra balloon will cause the dog bone effect to occur, resulting in the inability to effectively dilate the stenotic lesion and damage the normal blood vessels. Summary of the Invention

[0005] Based on this, in view of the technical problems of the poor pushing performance of the dilation catheter or the dog bone effect mentioned above, it is necessary to provide a catheter system.

[0006] This application provides a catheter system, which includes:

[0007] A support catheter, which has a support channel that penetrates through both ends inside, and a first axial positioning structure is provided on the support catheter; and,

[0008] At least one of a balloon catheter and a dilator, the balloon catheter is configured to be movably inserted into the support channel, the first axial positioning structure can be used to determine the relative position between the support catheter and the balloon catheter, the dilator is configured to be movably inserted into the support channel, and the first axial positioning structure can be used to determine the relative position between the support catheter and the dilator.

[0009] In one embodiment, the first axial positioning structure includes at least one first imaging element disposed at the distal end of the support catheter; and / or,

[0010] At least one first perfusion channel is provided in the side wall of the support catheter, and the first perfusion channel communicates with the support channel; and / or,

[0011] A locking and sealing element is provided at the proximal end of the support catheter; and / or,

[0012] At least a part of the outer tube wall of the support catheter is provided with a hydrophilic coating; and / or,

[0013] The diameter of the support catheter is 5F to 8F.

[0014] In one embodiment, the locking and sealing element includes:

[0015] A locking inner plug, the interior of which has a locking channel that penetrates through both ends. Among them, the locking inner plug includes an insertion section and a locking section that are connected to each other along the penetration direction of the locking channel. The insertion section is inserted and assembled with the proximal end of the support channel of the support catheter. The locking section includes at least two mutually cooperating locking flaps, and at least two of the locking flaps can be used to radially approach each other under a stressed state;

[0016] A locking outer cylinder, the interior of which has an assembly channel that penetrates through both ends. Among them, the locking outer cylinder includes a jacket section and a limiting section that are connected to each other along the penetration direction of the assembly channel. The jacket section is used to movably sleeve outside the support catheter and the locking inner plug. The limiting section is used to be in limiting contact with the locking flaps and apply a radial driving force to the locking flaps to drive at least two of the locking flaps to radially approach each other.

[0017] In one embodiment, the support catheter includes:

[0018] A support main pipe section;

[0019] A support connecting pipe section, the distal end of the support connecting pipe section is connected to the proximal end of the support main pipe. The first perfusion channel is provided on the support connecting pipe section. The insertion section is inserted and assembled with the proximal end of the support connecting pipe section. The jacket section is used to movably sleeve outside the support connecting pipe section and the locking inner plug. A limiting portion is provided on the support connecting pipe section, and the limiting portion is used for limiting cooperation with the jacket section.

[0020] In one embodiment, the balloon catheter includes:

[0021] An inner core tube, the interior of which has a core tube lumen that penetrates through both ends;

[0022] An outer sheath tube, the interior of the outer sheath tube having a sheath lumen that penetrates through both ends, and the outer sheath tube being movably sleeved outside the inner core tube;

[0023] A balloon body, the interior of the balloon body having a balloon lumen, the balloon body being sleeved outside the inner core tube, the distal opening of the balloon body being hermetically connected to the distal end of the inner core tube, and the proximal opening of the balloon body being hermetically connected to the distal end of the outer sheath tube;

[0024] A second axial positioning structure, the second axial positioning structure being provided on the inner core tube, and the first axial positioning structure and the second axial positioning structure being used in cooperation to determine the relative positions of the support catheter and the balloon catheter.

[0025] In one embodiment, the second axial positioning structure includes a plurality of second imaging elements provided on the inner core tube, and the plurality of second imaging elements are arranged along the axial direction of the inner core tube; and / or,

[0026] At least one second perfusion channel is provided on the side wall of the outer sheath tube, and the second perfusion channel communicates with the sheath lumen.

[0027] In one embodiment, the outer sheath tube includes:

[0028] An outer sheath main body tube section;

[0029] An outer sheath stress tube section, the distal end of the outer sheath stress tube section being connected to the proximal end of the outer sheath main body tube section,

[0030] An outer sheath connecting tube section, the distal end of the outer sheath connecting tube section being connected to the proximal end of the outer sheath stress tube section, and the second perfusion channel being provided on the outer sheath connecting tube section.

[0031] In one embodiment, the dilator includes:

[0032] A dilation catheter, the interior of the dilation catheter having a dilation lumen that penetrates through both ends;

[0033] A third axial positioning structure, the third axial positioning structure being provided on the dilation catheter, and the first axial positioning structure and the third axial positioning structure being used in cooperation to determine the relative positions of the support catheter and the dilation catheter.

[0034] In one embodiment, the third axial positioning structure includes:

[0035] At least one third imaging element, the third imaging element being provided at the distal end of the dilation catheter, and the third imaging element having a curved surface that expands radially outward; and / or,

[0036] A plurality of fourth developing elements, and the plurality of fourth developing elements are arranged along the axial direction of the dilation catheter.

[0037] In one embodiment, the dilation catheter includes:

[0038] A dilation main body section;

[0039] A dilation stress section, the distal end of the dilation stress section is connected to the proximal end of the dilation main body section,

[0040] A dilation connection section, the distal end of the dilation connection section is connected to the proximal end of the dilation stress section.

[0041] The catheter system provided in this application seamlessly combines a dilator, a balloon catheter, and a support catheter, thereby achieving variable support strength of the dilator and variable balloon body length of the balloon catheter, which is closer to clinical needs. The expandable length of the balloon body can be controllably adjusted through cooperation with the support catheter, which is beneficial for achieving effective dilation and reducing vascular damage (i.e., the dog-bone effect) caused by excessive dilation of blood vessels. The cooperation between the dilator and the support catheter can achieve adjustable support, which is beneficial for improving passability. The cooperation between the dilator and the support catheter can also have the function of injecting contrast agent, eliminating the need for an additional catheter insertion and simplifying the surgical operation. Description of the Drawings

[0042] Figure 1 It is a schematic structural diagram of the support catheter provided in one embodiment of this application.

[0043] Figure 2 It is a partial cross-sectional view of the support catheter provided in one embodiment of this application.

[0044] Figure 3 It is a schematic structural diagram of the balloon catheter provided in one embodiment of this application.

[0045] Figure 4 It is a partial schematic diagram of the balloon catheter provided in one embodiment of this application.

[0046] Figure 5 It is a radial cross-sectional view of the balloon catheter provided in one embodiment of this application.

[0047] Figure 6 It is a schematic structural diagram of the dilator provided in one embodiment of this application.

[0048] Figure 7 It is a schematic diagram of the cooperation between the support catheter and the balloon catheter provided in one embodiment of this application.

[0049] Figure 8 It is a schematic diagram of the cooperation between the support catheter and the dilator provided in one embodiment of this application.

[0050] Reference numerals in the attached drawings:

[0051] 1000, support catheter; 2000, balloon catheter; 3000, dilator;

[0052] 1000a, main support pipe section; 1000b, support connecting pipe section; 1000b1, limiting part;

[0053] 1100, first axial positioning structure; 1200, first perfusion channel; 1300, locking and sealing element;

[0054] 1310, locking inner plug; 1310a, inserted section; 1310b, locking section; 1310b1, locking flap;

[0055] 1320, locking outer cylinder; 1320a, outer sleeve section; 1320b, limiting section;

[0056] 2100, inner core tube; 2200, outer sheath tube; 2300, balloon body; 2400, second axial positioning structure; 2500, second perfusion channel;

[0057] 2200a, main outer sheath pipe section; 2200b, outer sheath stress pipe section; 2200c, outer sheath connecting pipe section;

[0058] 3100, dilatation catheter; 3200, third axial positioning structure;

[0059] 3100a, main dilatation pipe section; 3100b, dilatation stress pipe section; 3100c, dilatation connecting pipe section;

[0060] 3200a, third imaging element; 3200b, fourth imaging element. Detailed implementation manners

[0061] In order to make the above objects, features, and advantages of the present application more obvious and understandable, the following will describe the detailed implementation manners of the present application in conjunction with the accompanying drawings. Many specific details are set forth in the following description in order to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0062] In the description of the present application, it should be understood that if there are terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the drawings. These are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation on the present application.

[0063] In addition, if there are terms such as "first" and "second", these terms are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one such feature. In the description of the present application, if there is a term "plurality", the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0064] In the present application, unless otherwise clearly specified and limited, if there are terms such as "mounted", "connected", "connected to", "fixed", etc., these terms should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; 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, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0065] In the present application, unless otherwise clearly specified and limited, if there is a description such as a first feature being "on" or "under" a second feature, the meaning may be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0066] It should be noted that if an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there may also be an intermediate element. If an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation.

[0067] To describe the catheter system more clearly, the term "distal end" is defined herein as the end far from the operator during the surgical operation, and the "proximal end" means the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by those skilled in the technical field to which this application belongs. The terms used in this application in the specification are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0068] An embodiment of the present application provides a catheter system. First, as Figure 1 and Figure 2 shown, the catheter system includes a support catheter 1000. In addition, continuing to refer to Figures 3 to 5 shown, the catheter system further includes a balloon catheter 2000 used in cooperation with the support catheter 1000, or continuing to refer to Figure 6 shown, the catheter system may also include a dilator 3000.

[0069] Both the balloon catheter 2000 and the dilator 3000 are used in cooperation with the support catheter 1000. Therefore, the operator can select at least one of the support catheter 1000, the balloon catheter 2000, and the dilator 3000 for cooperation according to actual needs. For example, the support catheter 1000 and the balloon catheter 2000 are used in combination, or the support catheter 1000 and the dilator 3000 are used in combination, or the support catheter 1000 is used in combination with the balloon catheter 2000 and the dilator 3000. Therefore, those skilled in the art can construct the content and applicable scenarios of the catheter system according to actual needs, which are not limited herein. Therefore, the catheter system provided by this application may include a combination product of the support catheter 1000 and the balloon catheter 2000, or a combination product of the support catheter 1000 and the dilator 3000, or may include a combination product of the support catheter 1000, the balloon catheter 2000, and the dilator 3000 used together, which are not limited herein.

[0070] The interior of the support catheter 1000 has a support channel that penetrates through both ends. A first axial positioning structure 1100 is provided on the support catheter 1000. The material of the support catheter 1000 can be polypropylene, polytetrafluoroethylene, etc. The support catheter 1000 can be made by weaving. At least a part of the outer wall of the support catheter 1000 can also be provided with a hydrophilic coating. For example, the hydrophilic coating is provided in a certain area at the distal end of the support catheter 1000 by means such as coating. The main component of the hydrophilic coating can be polyvinylpyrrolidone (abbreviated as PVP). The hydrophilic coating can reduce the friction with the target blood vessel and improve the passing ability and pushability. The diameter of the support catheter 1000 can be limited to 5F to 8F, such as 5F, 6F, 7F, 8F, etc.

[0071] The balloon catheter 2000 can be movably inserted into the support channel. The operator can control the axial movement of the balloon catheter 2000 in the support channel during the operation to control the relative position of the balloon catheter 2000 and the support catheter 1000. In one embodiment, the balloon catheter 2000 includes an inner core tube 2100, an outer sheath tube 2200, a balloon body 2300, etc. The material of the inner core tube 2100 can be polycaprolactam. The interior of the inner core tube 2100 has a core tube lumen that penetrates through both ends, and the core tube lumen can be used to thread a guide wire. The distal end of the inner core tube 2100 can be provided with a tapered guiding head end.

[0072] The interior of the outer sheath tube 2200 has a sheath tube lumen that penetrates through both ends. The outer sheath tube 2200 is movably sleeved outside the inner core tube 2100. The annular gap formed between the outer sheath tube 2200 and the inner core tube 2100 can be used as a perfusion channel for contrast agent, etc. The material of the outer sheath tube 2200 can be polyamide 12 and Pebax, etc. For example, the outer sheath tube 2200 can be made by co-extruding polyamide 12 and Pebax, and the mixing ratio of the two can be limited to 5:5 to 8:2, so as to balance the supportability and flexibility of the outer sheath tube 2200. The surface of the outer sheath tube 2200 can be coated with a hydrophilic coating to improve the pushability and passing ability.

[0073] The interior of the balloon body 2300 has a balloon inner cavity. The balloon body 2300 is sleeved outside the inner core tube 2100. The distal opening of the balloon body 2300 is hermetically connected to the distal end of the inner core tube 2100, and the proximal opening of the balloon body 2300 is hermetically connected to the distal end of the outer sheath tube 2200. Materials for the balloon body 2300 can include polyamide 12 and Pebax, etc. Moreover, a double-layer structure can be constructed by the two materials of polyamide 12 and Pebax. Those skilled in the art can set the material ratio of the two materials according to actual design requirements, which is not limited herein. A hydrophilic coating can be provided on the surface of the balloon body 2300. The main component of the hydrophilic coating can be polyvinylpyrrolidone (abbreviated as PVP), and the friction force is reduced through the hydrophilic coating. The diameter of the balloon body 2300 can be limited to 2.0 mm to 14.0 mm, the length of the balloon body 2300 can be limited to 20 mm to 300 mm, and the pressure resistance of the balloon body 2300 can be limited to 10 atm to 30 atm. Those skilled in the art can adjust according to actual needs, which is not limited herein.

[0074] Referring to Figure 7 As shown, when the support catheter 1000 is sleeved outside the balloon catheter 2000, the support catheter 1000 is located outside the outer sheath tube 2200, and the distal end of the support catheter 1000 can be simultaneously sleeved in the proximal region outside the balloon body 2300. At this time, the proximal region part of the balloon body 2300 sleeved with the support catheter 1000 outside will be restricted by the support catheter 1000 and cannot expand radially, and the remaining region part of the balloon body 2300 not sleeved with the support catheter 1000 can expand normally. The operator can adjust the length of the support catheter 1000 sleeved on the balloon body 2300 during the operation, so as to adjust the expandable length of the balloon body 2300 in real time during the operation, and avoid or slow down the occurrence of vascular injury caused by excessive dilation of blood vessels.

[0075] The dilator 3000 is configured to be movably inserted through the support channel. The operator can control the axial movement of the dilator 3000 in the support channel during the operation to control the relative position of the dilator 3000 and the support catheter 1000. In one embodiment, the dilator 3000 can include a dilatation catheter 3100, and the interior of the dilatation catheter 3100 has a dilatation inner cavity that penetrates through both ends. The distal end of the dilator 3000 can form a tapered head end, and by presenting a certain taper, the passing ability of the dilator 3000 through the lesion is improved. Referring to Figure 8As shown, when the support catheter 1000 is sleeved outside the dilation catheter 3100, a certain degree of support can be provided to the dilation catheter 3100, and as the support catheter 1000 is at different positions of the dilation catheter 3100, the degree of support provided by the support catheter 1000 to the dilation catheter 3100 is also different. For example, when the support catheter 1000 is located at the distal end of the dilator 3000, strong support and pushability (pushability refers to whether it can be pushed to the lesion site) can be provided. When the distal end of the dilator 3000 extends out of the support catheter 1000, relatively flexible support and strong passability (passability refers to whether it can smoothly pass through the lesion) can be provided.

[0076] When the balloon catheter 2000 axially moves in the support channel, the operator can use the first axial positioning structure 1100 to determine the relative positions of the support catheter 1000 and the balloon catheter 2000. Similarly, when the dilator 3000 axially moves in the support channel, the operator can also use the first axial positioning structure 1100 to determine the relative positions of the support catheter 1000 and the dilator 3000. The first axial positioning structure 1100 can use various methods such as a scale structure, a positionable protrusion structure, a positionable groove structure, a visualization structure, etc. to determine the position of the support catheter 1000 relative to the balloon catheter 2000 or the dilator 3000.

[0077] For example, in one of the embodiments, the first axial positioning structure 1100 includes at least one first visualization element provided at the distal end of the support catheter 1000. The length of the first visualization element can be limited to 1 mm to 3 mm. The first visualization element can be used to position the support catheter 1000 during the operation by visualization, assist in determining the relative positions of the support catheter 1000 and the balloon catheter 2000, and further determine the length of the balloon body 2300. When the length of the balloon body 2300 needs to be adjusted during the operation, the operator can adjust the relative positions of the support catheter 1000 and the balloon catheter 2000 by observing the position of the first visualization element in the target blood vessel, so as to determine the expandable length of the balloon body 2300.

[0078] In addition, the balloon catheter 2000 may further include a second axial positioning structure 2400. The second axial positioning structure 2400 is provided on the inner core tube 2100. The first axial positioning structure 1100 and the second axial positioning structure 2400 are used in cooperation to determine the relative positions of the support catheter 1000 and the balloon catheter 2000. Similar to the first axial positioning structure 1100, the second axial positioning structure 2400 can also adopt a scale structure, a positionable protrusion structure, a positionable groove structure, a visualization structure, etc.

[0079] For example, in one of the embodiments, the second axial positioning structure 2400 includes a plurality of second imaging elements disposed on the inner core tube 2100, and the plurality of second imaging elements are arranged along the axial direction of the inner core tube 2100. The second imaging elements can be made of platinum-iridium alloy, and the second imaging elements can be fixed on the inner core tube 2100 by means such as forging. The relative positional relationship between the first imaging elements and the second imaging elements can be used to assist in determining the relative positions of the support catheter 1000 and the balloon catheter 2000. Those skilled in the art can determine the number and spacing of the second imaging elements according to the length of the balloon body 2300. For example, the spacing between adjacent second imaging elements can be limited to 20 mm to 60 mm.

[0080] The dilator 3000 may further include a third axial positioning structure 3200, and the third axial positioning structure 3200 is disposed on the dilation catheter 3100. The first axial positioning structure 1100 and the third axial positioning structure 3200 are used in cooperation to determine the relative positions of the support catheter 1000 and the dilation catheter 3100. Similar to the first axial positioning structure 1100, the third axial positioning structure 3200 can also adopt a scale structure, a positionable protrusion structure, a positionable groove structure, an imaging structure, etc.

[0081] For example, in one of the embodiments, the third axial positioning structure 3200 includes at least one third imaging element 3200a, and the third imaging element 3200a is disposed at the distal end of the dilation catheter 3100. The third imaging element 3200a has a curved surface that expands radially outward. For example, the shape of the third imaging element 3200a can be selected as a cone shape, an olive shape, a spherical shape, etc. The material of the third imaging element 3200a can be made of stainless steel, nitinol alloy, etc. Based on the shape of the third imaging element 3200a, when the contrast agent flows to the third imaging element 3200a, according to the principle of hydrodynamics, it can play an effect of promoting the dispersion of the contrast agent, which is beneficial to the dispersion of the contrast agent. Moreover, the shape of the third imaging element 3200a can also improve the ability to pass through lesions.

[0082] The third axial positioning structure 3200 includes a plurality of fourth imaging elements 3200b, and the plurality of fourth imaging elements 3200b are arranged along the axial direction of the dilation catheter 3100. The spacing between adjacent fourth imaging elements 3200b can be limited to 10 mm to 50 mm. According to the axial distribution of the fourth imaging elements 3200b, it can be used for intraoperative positioning and measuring the length of the lesion. The relative positional relationship between the first imaging elements and the third imaging element 3200a or the fourth imaging elements 3200b can be used to assist in determining the relative positions of the support catheter 1000 and the dilation catheter 3100.

[0083] At least one first perfusion channel 1200 is provided in the side wall of the support catheter 1000, and the first perfusion channel 1200 communicates with the support channel. For example, a connecting portion for forming the first perfusion channel 1200 may be provided on the side wall of the support catheter 1000, and the first perfusion channel 1200 communicating with the support channel is provided inside the connecting portion. Among them, the connecting portion can be made of polycarbonate, polypropylene, etc. The first perfusion channel 1200 can be used to inject lubricants such as normal saline to reduce the friction force with the dilator 3000 and the balloon catheter 2000 through normal saline or the like. Or the first perfusion channel 1200 can also be used to inject contrast agents to perform angiography on the target blood vessel. A locking and sealing element 1300 is provided at the proximal end of the support catheter 1000. The material of the locking and sealing element 1300 can be polycarbonate, polypropylene. The locking and sealing element 1300 can be used to lock and fix the dilator 3000, the balloon catheter 2000 or the guide wire during the operation. Moreover, the locking and sealing element 1300 can also play a certain sealing role.

[0084] In one embodiment, the locking and sealing element 1300 includes a locking inner plug 1310 and a locking outer cylinder 1320. The inside of the locking inner plug 1310 has a locking channel that penetrates through both ends. Among them, the locking inner plug 1310 includes an inserted section 1310a and a locking section 1310b that are connected to each other along the penetrating direction of the locking channel. The inserted section 1310a is inserted and assembled with the proximal end of the support channel of the support catheter 1000. The locking section 1310b includes at least two mutually cooperating locking flaps 1310b1, and the at least two locking flaps 1310b1 can be used to radially approach each other under a force state. The inside of the locking outer cylinder 1320 has an assembly channel that penetrates through both ends. Among them, the locking outer cylinder 1320 includes an outer sleeve section 1320a and a limiting section 1320b that are connected to each other along the penetrating direction of the assembly channel. The outer sleeve section 1320a is used to movably sleeved outside the support catheter 1000 and the locking inner plug 1310, and the limiting section 1320b is used to limit contact with the locking flap 1310b1 and apply a radial driving force to the locking flap 1310b1 to drive the at least two locking flaps 1310b1 to radially approach each other.

[0085] In one embodiment, the support catheter 1000 includes a support main body tube section 1000a and a support connecting tube section 1000b. The distal end of the support connecting tube section 1000b is connected to the proximal end of the support main body tube. The first perfusion channel 1200 is provided on the support connecting tube section 1000b. The inserted section 1310a is inserted and assembled with the proximal end of the support connecting tube section 1000b. The outer sleeve section 1320a is used to movably sleeved outside the support connecting tube section 1000b and the locking inner plug 1310. A limiting portion 1000b1 is provided on the support connecting tube section 1000b, and the limiting portion 1000b1 is used for limiting cooperation with the outer sleeve section 1320a.

[0086] In one embodiment, at least one second perfusion channel 2500 may be provided in the side wall of the outer sheath tube 2200, and the second perfusion channel 2500 communicates with the lumen of the sheath tube. For example, the outer sheath tube 2200 includes an outer sheath main tube section 2200a, an outer sheath stress tube section 2200b, and an outer sheath connection tube section 2200c. The distal end of the outer sheath stress tube section 2200b is connected to the proximal end of the outer sheath main tube section 2200a, and the distal end of the outer sheath connection tube section 2200c is connected to the proximal end of the outer sheath stress tube section 2200b. The material of the outer sheath stress tube section 2200b may be silicone, polyamide, etc., which plays a role in diffusing stress to prevent the outer sheath tube 2200 and the inner core tube 2100 from being bent. The outer sheath connection tube section 2200c may be made of materials such as polycarbonate and polypropylene. At this time, the above-mentioned second perfusion channel 2500 is provided on the outer sheath connection tube section 2200c. Therefore, the outer sheath connection tube section 2200c may have two Luer screw connectors. One Luer screw connector is used to form the second perfusion channel 2500 for injecting contrast agents, etc., and the other Luer screw connector is used to connect the lumen of the sheath tube for threading a guide wire.

[0087] In one embodiment, the dilation catheter 3100 includes a dilation main tube section 3100a, a dilation stress tube section 3100b, and a dilation connection tube section 3100c. The distal end of the dilation stress tube section 3100b is connected to the proximal end of the dilation main tube section 3100a, and the distal end of the dilation connection tube section 3100c is connected to the proximal end of the dilation stress tube section 3100b. The material of the dilation main tube section 3100a may be polytetrafluoroethylene, polypropylene, etc. The material of the dilation stress tube section 3100b may be silicone, polypropylene, polyamide, etc. to prevent the dilation catheter 3100 from being bent.

[0088] Refer to Figure 7 and Figure 8 As shown in

[0089] After the dilator 3000 is passed through the lesion in cooperation with the support catheter 1000, the dilator 3000 can be completely withdrawn from the support catheter 1000, and the distal end of the balloon catheter 2000 is threaded through the guide wire and into the support catheter 1000.

[0090] Taking the balloon body 2300 with a diameter of 5.0 mm and a length of 180 mm as an example, 4 second imaging elements can be forged on a part of the inner core tube 2100 inside the balloon body 2300. According to intraoperative angiography, the length of the stenotic blood vessel is about 120 mm. Therefore, the expandable length of the balloon body 2300 can be adjusted to about 120 mm to match the length of the balloon body 2300 with the stenotic blood vessel, so as to achieve more effective dilation and reduce the vascular injury (i.e., the dog-bone effect) caused by over-dilation of the blood vessel.

[0091] Based on real-time angiography, the operator can utilize the relative positional relationship between the first imaging element and the second imaging element, such as their coincidence, thereby limiting the expandable length of the balloon body 2300 to about 120 mm. At this time, the balloon catheter 2000 can be fixed by using the locking and sealing element 1300 first, and then the filling device is connected to the balloon catheter 2000, and the contrast agent is injected into the balloon body 2300 to make the diameter of the expandable part of the balloon body 2300 basically consistent with the inner diameter of the stenotic blood vessel. After maintaining the pressure for a period of time, the contrast agent is withdrawn, and finally the balloon catheter 2000 is withdrawn.

[0092] For lesions of other lengths, dilation treatment can be carried out based on the above similar steps.

[0093] As can be seen from the above, the catheter system provided by the present application combines the dilator 3000, the balloon catheter 2000 and the support catheter 1000, so as to achieve the variable support strength of the dilator 3000 and the variable length of the balloon body 2300 of the balloon catheter 2000, which is closer to the clinical needs. The expandable length of the balloon body 2300 can be controllably adjusted through cooperation with the support catheter 1000, which is beneficial to achieving effective dilation and reducing the vascular injury (i.e., the dog-bone effect) caused by over-dilation of the blood vessel. The cooperation between the dilator 3000 and the support catheter 1000 can achieve adjustable supportiveness, which is beneficial to improving the passageability. The cooperation between the dilator 3000 and the support catheter 1000 can also have the function of injecting the contrast agent, without the need to additionally insert a catheter, which simplifies the surgical operation.

[0094] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0095] The above-described embodiments merely represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patented application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all fall within the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A catheter system, characterized in that: The catheter system comprises: A support conduit, wherein the interior of the support conduit has a support passage with two ends extending therethrough, and the support conduit is provided with a first axial positioning structure; and At least one of a balloon catheter and a dilator, the balloon catheter is configured to be movably inserted into the support channel, and the first axial positioning structure can be used to determine the relative positions of the support catheter and the balloon catheter, and the dilator is configured to be movably inserted into the support channel, and the first axial positioning structure can be used to determine the relative positions of the support catheter and the dilator.

2. The catheter system according to claim 1, characterized in that The first axial positioning structure includes at least one first developing element disposed at the distal end of the support catheter; and / or, The side wall of the supporting conduit is provided with at least one first perfusion channel, and the first perfusion channel is connected with the supporting channel; and / or, The proximal end of the support catheter is provided with a locking sealing element; and / or, At least a portion of the outer wall of the supporting conduit is provided with a hydrophilic coating; and / or, The diameter of the supporting catheter is 5F to 8F.

3. The catheter system according to claim 2, characterized in that The locking sealing element comprises: A locking inner plug, wherein the locking inner plug has a locking channel with two ends passing through it, wherein the locking inner plug includes an interlocking section and a locking section connected to each other along the through direction of the locking channel, the interlocking section is plug-fitted and assembled with the proximal end of the support channel of the support catheter, and the locking section includes at least two locking petals that cooperate with each other, and the at least two locking petals can be used to radially approach each other under a force state; A locking outer cylinder, wherein the interior of the locking outer cylinder has an assembly channel that passes through both ends, wherein the locking outer cylinder includes an outer sleeve section and a limiting section that are interconnected along the through direction of the assembly channel, the outer sleeve section is used to be movably sleeved on the outside of the supporting conduit and the locking inner plug, and the limiting section is used to be in limiting contact with the locking flap, apply a radial driving force to the locking flap, and drive at least two of the locking flaps to radially approach each other.

4. The catheter system according to claim 3, characterized in that The supporting conduit comprises: Support the main pipe section; A support connecting pipe segment, the distal end of which is connected to the proximal end of the supporting main body tube, the first perfusion channel is opened on the support connecting pipe segment, the inserted section is plug-fitted and assembled with the proximal end of the support connecting pipe segment, the outer sleeve segment is used for movably sleeved on the outside of the support connecting pipe segment and the locking inner plug, and a limiting portion is provided on the support connecting pipe segment, and the limiting portion is used for limiting cooperation with the outer sleeve segment.

5. The catheter system according to claim 1, characterized in that The balloon catheter comprises: An inner core tube, wherein the inner core tube has a core tube inner cavity with two ends connected therein; An outer sheath tube, wherein the inner portion of the outer sheath tube has a sheath tube inner cavity with two ends connected therethrough, and the outer sheath tube is movably sleeved on the outer portion of the inner core tube; A balloon body, wherein the interior of the balloon body has a balloon inner cavity, the balloon body is sleeved on the outside of the inner core tube, the distal opening of the balloon body is sealed and connected to the distal end of the inner core tube, and the proximal opening of the balloon body is sealed and connected to the distal end of the outer sheath tube; A second axial positioning structure, wherein the second axial positioning structure is arranged on the inner core tube, and the first axial positioning structure and the second axial positioning structure are used to cooperate to determine the relative position of the supporting catheter and the balloon catheter.

6. The catheter system according to claim 5, characterized in that The second axial positioning structure comprises a plurality of second developing elements arranged on the inner core tube, and the plurality of second developing elements are arranged along the axial direction of the inner core tube; and / or, The side wall of the outer sheath tube is provided with at least one second perfusion channel, and the second perfusion channel is communicated with the inner cavity of the sheath tube.

7. The catheter system according to claim 6, characterized in that The outer sheath comprises: Outer sheath main tube section; an outer sheath stress pipe section, wherein the distal end of the outer sheath stress pipe section is connected to the proximal end of the outer sheath main pipe section, An outer sheath connecting pipe section, the distal end of which is connected to the proximal end of the outer sheath stress pipe section, and the second perfusion channel is arranged on the outer sheath connecting pipe section.

8. The catheter system according to claim 1, characterized in that The expander comprises: A dilatation catheter, wherein the interior of the dilatation catheter has a dilatation lumen with two ends connected therethrough; A third axial positioning structure is provided on the dilatation catheter, and the first axial positioning structure and the third axial positioning structure are used to cooperate to determine the relative position of the support catheter and the dilatation catheter.

9. The catheter system according to claim 8, characterized in that The third axial positioning structure comprises: at least one third developing element, the third developing element being disposed at the distal end of the dilatation catheter, the third developing element having a curved surface that expands radially outward; and / or, A plurality of fourth developing elements are arranged along the axial direction of the dilatation catheter.

10. The catheter system according to claim 9, characterized in that The dilatation catheter comprises: Expand the main pipe section; an expanded stress pipe section, wherein the distal end of the expanded stress pipe section is connected to the proximal end of the expanded main pipe section, An expansion connecting pipe section, wherein the distal end of the expansion connecting pipe section is connected to the proximal end of the expansion stress pipe section.

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