Three-cavity microcatheter

Abstract

The present application relates to the technical field of medical instruments and particularly to a three-cavity microcatheter. The three-cavity microcatheter comprises: a first tube body, wherein a guide wire cavity is formed in the first tube body; a second tube body; a third tube body, wherein at least one guide wire outlet is formed in a sidewall of the far end of the first tube body, the guide wire outlet is in communication with the guide wire cavity, and a far end part of the second tube body, a far end part of the first tube body, and a far end part of the third tube body are arranged side by side in a flat shape such that, when the three-cavity microcatheter enters an inner space of the tunica vasculosa, the at least one guide wire outlet faces the tunica intima and / or the tunica media; and a positioning mark, wherein the second tube body and / or the third tube body are provided with the positioning mark, and the positioning mark is configured for positioning the guide wire outlet of the first tube body. The solutions provided by the present application enable a directional puncture of the puncture guide wire reentering the true vascular lumen from the subintimal space, increasing the success rate of one-time surgery.

Description

Triple-lumen microcatheter Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a three-lumen microcatheter. Background Art

[0002] Chronic total occlusion (CTO) lesions, the last remaining barrier to percutaneous coronary intervention (PCI), remain the most challenging procedure for PCI physicians. Both in Europe, America, and the Asia-Pacific region, a streamlined approach to recanalizing CTO lesions exists. In China, CTO-PCI recanalization strategies are primarily categorized into four types: antegrade wire escalation (AWE), retrograde wire escalation (RWE), antegrade dissection and re-entry (ADR), and retrograde dissection and re-entry (RDR). Typically, antegrade wire escalation (including parallel wire escalation) can recanalize approximately 70% of CTO lesions. Combined with retrograde wire escalation, the success rate of CTO recanalization increases to 85%-90%. When the forward and retrograde guidewire upgrade techniques still cannot open the CTO lesions, the antegrade dissection reentry into the true lumen (ADR) technology, as a remedial measure for the forward and retrograde guidewire upgrade techniques, will further improve the success rate of opening the CTO lesions.

[0003] Anterior dissection reentry (ADR) refers to a surgical strategy in which an instrument is introduced along a guidewire within the antegrade true lumen, passing through the subintimal region of the occluded segment to reach the landing zone distal to the lesion, and then, with the assistance of the instrument, the guidewire is used to re-puncture back into the true lumen of the vessel. During the procedure, as shown in Figure 1, a catheter (such as CrossBoss) is used to bluntly dissect the subintimal region of the lesion. The puncture guidewire 1' then passes through the CTO segment along the false lumen outside the vessel and, with the help of other instruments, returns to the true lumen. Figure 1 shows the process of the puncture guidewire 1', which is located between the intima 2' and media 3' of the vessel, puncturing back into the true lumen of the vessel.

[0004] Currently, the catheters commonly used in ADR surgery not only have poor pushability, but may also cause the puncture guidewire 1' to be unable to re-puncture the true lumen, resulting in surgical failure. In addition, the catheter must perform balloon pretreatment, dilation, suction, and puncture in the intima, making the surgical process complex and difficult to widely use.

[0005] Summary of the Invention

[0006] In view of this, the present application proposes a three-lumen microcatheter, which aims to solve the problem that the puncture guidewire is difficult to return to the true lumen of the blood vessel.

[0007] The present application proposes a three-lumen microcatheter, which includes: a first tube body, in which a guidewire cavity is formed; a second tube body; a third tube body; at least one guidewire outlet is opened on the side wall of the distal end of the first tube body, and the guidewire outlet is connected to the guidewire cavity; the second tube body is arranged side by side in a flat shape with the distal end portion of the first tube body and the distal end portion of the third tube body, so that when the three-lumen microcatheter enters the intramedullary space of the blood vessel, at least one of the guidewire outlets faces the endothelium and / or the media of the blood vessel; a positioning mark, the second tube body and / or the third tube body are provided with the positioning mark.

[0008] In one embodiment, the axes of the first tube, the second tube, and the third tube are parallel, and the first tube, the second tube, and the third tube are located in the same plane.

[0009] In one embodiment, there are two guidewire outlets, and the two guidewire outlets are opened on opposite side walls of the first tube body, and the axes of the two guidewire outlets are perpendicular to the plane.

[0010] In one embodiment, the two guidewire outlets are spaced apart in the axial direction of the first tube, and the positioning mark is arranged opposite to the area between the two guidewire outlets.

[0011] In one embodiment, the positioning mark includes:

[0012] a first developing mark, provided on the second tube body;

[0013] The second development mark is provided on the third tube body. The first development mark and the second development mark correspond to the guide wire outlet. The first development mark and the second development mark cooperate to locate the guide wire outlet.

[0014] In one embodiment, the first development mark and the second development mark are symmetrically arranged relative to the first tube body.

[0015] In one embodiment, the positioning mark is a developing marker ring or a developing marker wire.

[0016] In one embodiment, the first tube body includes a proximal tube segment and a distal tube segment connected to each other, and the guidewire outlet is located on the side wall of the distal tube segment;

[0017] The third tube body includes a proximal tube body and a distal tube body connected to each other. The proximal tube body and the proximal tube section are arranged in parallel, and the distal tube body, the distal tube section and the second tube body are arranged in parallel in a flat shape.

[0018] In one embodiment, the distal ends of the first tube body, the second tube body, and the third tube body are arranged in a stepped manner.

[0019] In one embodiment, the second tube body and the third tube body are placed on both sides of the first tube body, and the distal end of the second tube body is at the farthest end position of the stepped arrangement, or the distal end of the third tube body is at the farthest end position of the stepped arrangement.

[0020] In one embodiment, when the distal end of the second tube is at the distalmost position of the stepped arrangement, the cross-section of the distal end of the second tube gradually decreases in the direction from the proximal end to the distal end, and the distal ends of the first tube and the third tube are inclined surfaces; or

[0021] When the distal end of the third tube is at the distalmost position of the stepped arrangement, the cross-section of the distal end of the third tube gradually becomes smaller in the direction from the proximal end to the distal end, and the distal ends of the first tube and the second tube are inclined surfaces.

[0022] In one embodiment, the second tube body and the third tube body are respectively placed on both sides of the first tube body, and the distal end of the first tube body protrudes beyond the distal ends of the second tube body and the third tube body.

[0023] In one embodiment, the first tube body further includes a stress relief tube segment, one end of the stress relief tube segment is connected to the proximal tube segment, and the other end is used to be connected to the catheter seat, and the internal spaces of the stress relief tube segment, the proximal tube segment and the distal tube segment are connected to form the guidewire cavity; and / or

[0024] The third tube body also includes a stress relief tube body, one end of which is connected to the proximal tube body, and the other end is used to connect to the catheter seat. The internal spaces of the stress relief tube body, the proximal tube body and the distal tube body are connected to form the cavity.

[0025] Compared with the balloon catheter in the related art, the three-lumen microcatheter in the present application can realize directional puncture of the puncture guidewire from the subintima to the true lumen of the blood vessel. For example, when the three-lumen microcatheter enters the intramedullary space (the intramedullary space refers to the space after the separation of the intima and the media), because the first tube body, the second tube body and the third tube body are arranged side by side in a flat shape, under the pressure of the intima and the media, the three-lumen microcatheter will deflect so that at least one guidewire outlet faces the intima and / or the media; when the guidewire outlet faces the intima, the puncture guidewire can pass through the guidewire outlet along the first guidewire cavity, penetrate the intima, and return to the true lumen of the blood vessel. Even when the position and orientation of the three-lumen microcatheter are not good after it is delivered, that is, the guidewire outlet is not facing the intima of the blood vessel and there is a certain deviation, because it is a three-tube setting and the tube body has a reinforcement layer (spring and / or braided layer) that can be properly twisted to make the guidewire outlet face the intima, the success rate of the puncture guidewire returning to the true lumen of the blood vessel is improved, thereby increasing the success rate of the one-time operation to the greatest extent possible. As can be seen, compared to the complex balloon preconditioning, expansion, and aspiration procedures required by related art balloon catheters, the triple-lumen microcatheter of this application is easy to operate, the surgical procedure is relatively simple, and it is easy to promote and apply. Furthermore, the parallel arrangement of the first, second, and third tubes of the triple-lumen microcatheter of this application enables rapid subintimal insertion and withdrawal of the lesion, providing excellent pushability.

[0026] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above and other objects, features and advantages of the present application will become more apparent through a more detailed description of exemplary embodiments of the present application in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments of the present application.

[0028] FIG1 is a schematic diagram of a forward dissection reentry true lumen surgical procedure in the related art;

[0029] FIG2 is a schematic structural diagram of a three-lumen microcatheter according to an embodiment of the present application;

[0030] FIG3 is a cross-sectional view taken along section AA of FIG2 ;

[0031] FIG4 is a cross-sectional view along section BB of FIG2 ;

[0032] FIG5 is a schematic structural diagram of the distal end portion of the three-lumen microcatheter shown in FIG2 ;

[0033] FIG6 is a schematic structural diagram of a three-lumen microcatheter according to another embodiment of the present application;

[0034] FIG7 is a cross-sectional view taken along section CC of FIG6;

[0035] FIG8 is an overall cross-sectional view of a three-lumen microcatheter according to another embodiment of the present application;

[0036] FIG9 is a schematic diagram of the three-dimensional structure of the distal end portion of the three-lumen microcatheter shown in FIG8;

[0037] FIG10 is a cross-sectional view of the distal end portion of the triple-lumen microcatheter shown in FIG8;

[0038] FIG11 is an overall cross-sectional view of a three-lumen microcatheter according to another embodiment of the present application;

[0039] FIG12 is a schematic diagram of the three-dimensional structure of the distal end portion of the three-lumen microcatheter shown in FIG11;

[0040] FIG13 is a cross-sectional view of the distal end portion of the triple-lumen microcatheter shown in FIG11;

[0041] FIG14 is a schematic diagram of a first state of a three-lumen microcatheter provided in an embodiment of the present application entering the intravascular space;

[0042] FIG15 is a schematic diagram of a second state of a three-lumen microcatheter provided in an embodiment of the present application entering the intravascular space;

[0043] FIG16 is a cross-sectional view of a portion of the first tube body of a three-lumen microcatheter provided in an embodiment of the present application;

[0044] FIG17 is an overall cross-sectional view of a three-lumen microcatheter according to another embodiment of the present application. DETAILED DESCRIPTION

[0045] The following describes embodiments of the present application in more detail with reference to the accompanying drawings. Although the accompanying drawings illustrate embodiments of the present application, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. Rather, these embodiments are provided to make the present application more thorough and complete, and to fully convey the scope of the present application to those skilled in the art.

[0046] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. As used in this application and the appended claims, the singular forms "a," "an," "the," and "the" are intended to include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

[0047] It should be understood that although the terms "first", "second", "third", etc. may be used in this application to describe various information, this information should not be limited to these terms. These terms are only used to distinguish information of the same type from each other. For example, without departing from the scope of this application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0048] The technical solutions of the embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0049] Referring to Figures 2 to 5, a three-lumen microcatheter according to an embodiment of the present application includes: a positioning marker, a first tube body 100, a second tube body 200, and a third tube body 300. Among them, a guidewire cavity 100a is formed in the first tube body 100, and the guidewire cavity 100a can be used for running a puncture guidewire. At least one guidewire outlet 121 is opened on the side wall of the distal end of the first tube body 100, and at least one guidewire outlet 121 is connected to the guidewire cavity 100a. The puncture guidewire can pass through the guidewire outlet 121 to the outside of the first tube body 100. It should be noted that the distal end in the embodiment of the present application refers to the right end shown in Figure 2.

[0050] The distal ends of the second tube body 200, the first tube body 100 and the third tube body 300 are arranged side by side in a flat shape so that when the three-lumen microcatheter enters the intravascular tunica space, at least one guidewire outlet 121 faces the vascular intima A and / or the tunica media B.

[0051] It should be noted that, referring to FIG. 14 and FIG. 15 , the intravascular membrane space mentioned in this embodiment refers to the space after the intima A and the media B of the blood vessel are separated.

[0052] The second tube body 200 and / or the third tube body 300 are provided with positioning marks, which are used to locate the guidewire outlet 121 of the first tube body 100, facilitating the passage of the puncture guidewire from the guidewire outlet 121 during surgery. The positioning marks shown in the figure include a first imaging mark 410 and a second imaging mark 420, which are provided on the second tube body 200 and the third tube body 300, respectively. In other embodiments, the positioning marks may be provided only on the second tube body 200 or the third tube body 300.

[0053] Compared with the balloon catheter in the related art, the three-lumen microcatheter in the present application can realize directional puncture of the puncture guidewire from the subendothelium to the true lumen of the blood vessel. For example, when the three-lumen microcatheter enters the intramedullary space (the intramedullary space refers to the space after the endothelium A and the media B are separated), because the first tube body 100, the second tube body 200 and the third tube body 300 are arranged side by side in a flat shape, under the pressure of the endothelium A and the media B, the three-lumen microcatheter will deflect so that at least one guidewire outlet 121 is directed toward the vascular endothelium A and / or the media B; when the guidewire outlet 121 is directed toward the endothelium A, the puncture guidewire can pass through the guidewire outlet along the first guidewire cavity 100a, pierce the endothelium, and return to the true lumen of the blood vessel. Even when the three-lumen microcatheter is not in a good position after being delivered, that is, the guidewire outlet 121 is not facing the vascular endothelium A, and there is a certain deviation, because it is a three-tube setting and the tube body has a reinforcement layer (spring and / or braided layer), it can be properly twisted to make the guidewire outlet 121 face the endothelium, thereby improving the success rate of the puncture guidewire returning to the true lumen of the blood vessel, thereby increasing the success rate of the one-time operation to the greatest extent possible. It can be seen that compared with the complex actions of balloon pretreatment, expansion, suction, etc. that the balloon catheter in the related art needs to perform, the three-lumen microcatheter in this application is easy to operate, the surgical procedure is relatively simple, and it is easy to promote and apply. In addition, the first tube body, the second tube body and the third tube body of the three-lumen microcatheter in this application are arranged side by side, which can achieve rapid entry into the subendothelium of the lesion position and rapid withdrawal, and has good pushing performance.

[0054] In some embodiments, the axes of the first tube 100, the second tube 200 and the third tube 300 are parallel and located in the same plane, so that the triple-lumen microcatheter is more easily deflected in the intravascular space.

[0055] Among them, there are two guidewire outlets 121, and the two guidewire outlets 121 are opened on the opposite side walls of the guidewire cavity 100a. The axes of the two guidewire outlets 121 are perpendicular to the plane where the first tube body 100, the second tube body 200 and the third tube body 300 are located. Of course, they can also be set at an angle.

[0056] In some embodiments, the two guidewire outlets 121 are spaced apart along the axial direction of the first tube 100, and the positioning mark is disposed relative to the area between the two guidewire outlets 121. The two guidewire outlets 121 are spaced apart along the axial direction of the first tube 100, and the spacing between the two guidewire outlets 121 along the axial direction of the first tube 100 can be greater than or equal to 0.5 mm. Increasing the spacing between the two guidewire outlets along the axial direction of the first tube 100 facilitates puncture of the puncture guidewire. The guidewire outlet 121 can be circular, elliptical, or other shapes, and is elliptical in the embodiment shown in FIG2.

[0057] The two guide wire outlets 121 can be distributed in a 180° direction on the circumference of the first tube body 100. When the guide wire outlet 121 is elliptical, the short axis length of the guide wire outlet 121 is greater than or equal to 0.3 mm; when the guide wire outlet 121 is circular, the aperture of the guide wire outlet 121 is greater than or equal to 0.3 mm. For example, the inner diameter of the guide wire outlet 121 can be ” (0.36mm). The two guide wire outlets may have a spacing along the axial direction of the first tube body 100. The spacing can be determined according to actual conditions and is not limited here.

[0058] After the three-lumen microcatheter in the embodiment of the present application reaches between the vascular endothelium A and the tunica media B and is flipped, one of the two guidewire outlets 121 faces the vascular endothelium A, and the other faces the vascular tunica media B. The puncture guidewire can only penetrate the endothelium A but not the tunica media B. The guidewire outlet 121 facing the endothelium is determined by whether it can successfully pass through.

[0059] In some embodiments, the second tube body 200 and the third tube body 300 are placed on both sides of the first tube body 100, and positioning marks are set on the second tube body 200 and the third tube body 300. The positioning marks are used to position the guidewire outlet 121 of the first tube body 100 so that the puncture guidewire passes through the guidewire outlet 121 when the guidewire outlet 121 is facing the vascular endothelium A.

[0060] In some embodiments, the positioning marks include a first display mark 410 and a second display mark 420. The first display mark 410 is disposed on the second tube body 200, and the second display mark 420 is disposed on the third tube body 300. Both the first display mark 410 and the second display mark 420 can be annular. The first display mark 410 and the second display mark 420 correspond to the guidewire outlet 121, and the first display mark 410 and the second display mark 420 cooperate to locate the position and orientation of the guidewire outlet 121.

[0061] The first developing mark 410 and / or the second developing mark 420 may be made of a developing material, such as a resin material containing radiopaque metals such as tungsten, bismuth, and barium, or a radiopaque metal material such as platinum, iridium, and gold.

[0062] In some embodiments, the first and second development marks 410, 420 correspond to the area between the two guidewire outlets 121 and are symmetrically arranged relative to the first tube 100. In other embodiments, the first and second development marks 410, 420 correspond to the area between the two guidewire outlets 121 and are staggered.

[0063] During positioning, the first and second imaging markers 410, 420 are observed to determine whether the three-lumen microcatheter is in a triple-track or single-track state, facing the intima. The imaging device illuminates from one direction. If the first and second imaging markers 410, 420 overlap, it indicates a single-track state, as shown in Figure 5. If the first and second imaging markers 410, 420 separate, it indicates a triple-track state, as shown in Figure 4. If the triple-track sign is facing the intima A, puncture can be performed. Alternatively, if the three-lumen microcatheter is not in the correct position after insertion, appropriate twisting can be performed to ensure a successful puncture.

[0064] As shown in FIG. 2 to FIG. 5 , the positioning mark is a developing mark ring, that is, the positioning mark is a circular ring structure.

[0065] In some embodiments, as shown in Figures 3 and 4 , the guidewire lumen 100a of the first tube 100 can be an OTW (Over the Wire) guidewire lumen. The first tube 100 can have a three-layer design, comprising an outer tube layer 140, a middle reinforcement layer 150, and a smooth inner layer 160. This can be used for guiding a puncture guidewire and aspirating blood, fluids, etc. The inner lumen 240 of the second tube 200 can be a rapid exchange lumen. The second tube 200 can have a two-layer design, comprising an outer layer 220 and an inner layer 230, facilitating the insertion and removal of instruments and saving surgical time. The lumen 300a of the third tube 300 can be a suction lumen, used to aspirate blood, fluids, etc. during surgery. The third tube 300 comprises an outer layer 340, a middle reinforcement layer 360, and an inner layer 350. The inner layer can be made of PTFE (Poly tetrafluoroethylene) or other smooth resin materials, while the middle reinforcement layer can optionally be constructed of a metal braid and / or metal spring structure.

[0066] As shown in Figures 2 and 5, in some embodiments, a radiopaque tip 250 is provided at the distal end of the second tube 200. The tip 250 extends distally relative to the first tube 100 and the third tube 300, and the tip 250 can be used for visualization and positioning during surgery.

[0067] As shown in Figures 6 and 7, an embodiment of the present application provides another three-lumen microcatheter, wherein the positioning mark is a developing marking wire, and a developing marking wire is provided on the second tube body 200 and the third tube body 300 respectively. The two developing marking wires are a first developing mark 410 and a second developing mark 420 respectively. The first developing mark 410 is set on the second tube body 200, and the second developing mark 420 is set on the third tube body 300.

[0068] The first developing mark 410 is provided on the side of the second tube 200 away from the first tube 100, and is parallel to the axis of the second tube 200. The second developing mark 420 is provided on the side of the third tube 300 away from the first tube 100, and is parallel to the axis of the third tube 300.

[0069] As shown in Figures 8 to 10, an embodiment of the present application provides another three-lumen microcatheter, wherein a first tube body 100 includes a proximal tube segment 110 (located in region A in Figure 8) and a distal tube segment 120 (located in region B in Figure 8), which are connected to each other. A guidewire lumen 100a extends through the proximal tube segment 110 and the distal tube segment 120. A guidewire outlet 121 is provided on the sidewall of the distal tube segment 120. A puncture guidewire can pass through the guidewire lumen 100a and exit the first tube body 100 through the guidewire outlet 121.

[0070] It should be noted that the proximal end in the embodiment of the present application refers to the left end shown in FIG. 8 .

[0071] Referring to FIG. 8 , the third tube body 300 may include a connected proximal tube body 310 (the portion of the third tube body 300 located in region A) and a distal tube body 320 (the portion of the third tube body 300 located in region B). A cavity 300a is formed within the third tube body 300, extending through both the proximal and distal tube bodies 310 and 320. The proximal tube body 310 is arranged in parallel with the proximal tube segment 110 in a flat configuration, while the distal tube body 320 is arranged in parallel with the distal tube segment 120 and the second tube body 200 in a flat configuration. In other words, the first tube body 100 and the third tube body 300 are connected in parallel, while the second tube body 200, the distal tube segment 120 of the first tube body, and the distal tube body 320 of the third tube body are further connected in parallel. The first, second, and third tube bodies 100, 200, and 300 may be integrally formed, or alternatively, they may be connected by welding, bonding, or other methods.

[0072] In some embodiments, the guidewire lumen 100a in the first tubular body 100 and the lumen in the third tubular body 300 can both be OTW (Over the Wire) guidewire lumens. Of course, they can also be lumens of other structures, as long as the guidewire lumen 100a in the first tubular body 100 can pass a puncture guidewire and a guidewire, and can also aspirate hematomas, etc., and the lumen in the third tubular body 300 can aspirate hematomas, etc. The lumen in the second tubular body 200 can be a lumen of any structure and is not limited here.

[0073] It can be understood that suction ports are provided at the distal ends of the first tube body 100 and the third tube body 300, and the cavities in the first tube body 100 and the third tube body 300 are used to suck hematoma, liquid, etc. through the suction ports.

[0074] During surgery, the guidewire cavity 100a of the first tube body 100 can be used for guiding guidewires and puncture guidewires, and the cavity in the first tube body 100 and / or the third tube body 300 can be used for aspirating hematomas, liquids, etc.

[0075] Referring to Figures 8, 14 and 15, during operation, a finger guidewire is arranged in the guidewire cavity 100a in the first tube body 100, and the finger guidewire will first enter between the vascular intima A and the tunica media B, and then the three-lumen microcatheter in the embodiment of the present application will enter between the intima A and the tunica media B along the finger guidewire. After the three-lumen microcatheter reaches between the intima A and the tunica media B of the blood vessel, it will be deflected due to the action of force. After the deflection, the guidewire outlet in the guidewire cavity 100a of the first catheter 100 is directed toward the vascular intima A, and then the finger guidewire is withdrawn from the guidewire cavity 100a, and then the puncture guidewire enters the guidewire cavity 100a of the first tube body 100, and the puncture guidewire punctures the intima through the guidewire outlet 121. After the puncture is completed, the three-lumen microcatheter is withdrawn from the human body along the puncture guidewire, and the puncture guidewire will remain in the human body to assist in completing subsequent operations. During surgery, the doctor can simultaneously aspirate blood, fluid, etc. through the cavities in the third tube 300 and the first tube 100 to reduce surgery time. Of course, it is also possible to simultaneously aspirate blood, fluid, etc. through only the cavities in the third tube 300 or the first tube 100 according to surgical needs.

[0076] During surgery, the guidewire cavity 100a of the first tube body 100 can be used for running a puncture guidewire, the cavity inside the third cavity 300 can be used for running a guiding guidewire, and the cavity inside the first tube body 100 and / or the third tube body 300 can be used for aspirating hematoma, liquid, etc.

[0077] 11 to 13 , an embodiment of the present application provides another triple-lumen microcatheter. During operation, a finger guidewire is arranged in the lumen 300a of the third tube body 300. The finger guidewire will first enter between the intima A and the media B of the blood vessel, and then the triple-lumen microcatheter in the embodiment of the present application will enter between the intima A and the media B along the finger guidewire. After the triple-lumen microcatheter reaches the intima A and the media B of the blood vessel, it will be deflected due to the force. After the deflection, the guidewire outlet in the guidewire lumen of the first catheter 100 is directed toward the intima of the blood vessel. After the triple-lumen microcatheter reaches the intima A and the media B of the blood vessel, the finger guidewire is withdrawn from the lumen in the third tube body 300, and then the puncture guidewire enters the guidewire lumen of the first tube body 100. The puncture guidewire punctures the intima through the guidewire outlet 121 and enters the distal end of the lesion in the true lumen of the blood vessel. After the puncture guidewire completes the puncture, the triple-lumen microcatheter is withdrawn from the human body along the puncture guidewire, and the puncture guidewire will remain in the human body to assist in completing subsequent operations. During surgery, the doctor can simultaneously aspirate blood, fluid, etc. through the cavities in the third tube 300 and the first tube 100 to reduce surgery time. Of course, it is also possible to simultaneously aspirate blood, fluid, etc. through only the cavities in the third tube 300 or the first tube 100 according to surgical needs.

[0078] In some embodiments, the guidewire lumen 100a within the first tubular body 100 may be an OTW (Over the Wire) lumen for guiding a puncture guidewire and for aspirating hematomas, fluids, etc. The lumen within the third tubular body 300 may also be an OTW (Over the Wire) lumen for aspirating hematomas, fluids, etc. The lumen within the second tubular body 200 may be a rapid exchange lumen (Rx) for guiding a guidewire. Of course, the lumens within the first tubular body 100, the second tubular body 200, and the third tubular body 300 may also have other structures, as long as they can achieve the above functions.

[0079] It can be understood that a suction port 321 is provided at the distal end of the first tube body 100 and the third tube body 300. Referring to Figure 17, the embodiment of the present application provides another three-lumen microcatheter, and the cavities in the first tube body 100 and the third tube body 300 suck hematoma, liquid, etc. through the suction port.

[0080] During surgery, the guidewire lumen 100a of the first tube body 100 is used for running a puncture guidewire, and the lumen in the second tube body 200 is used for running a guiding guidewire. The lumens in the first tube body 100 and / or the third tube body 300 can be used to aspirate hematomas, fluids, etc.

[0081] Referring to Figure 17, during operation, the cavity inside the second tube body 200 is arranged with a finger guide wire, which will first enter between the intima A and the media B of the blood vessel, and then the three-lumen microcatheter in the embodiment of the present application will enter between the intima A and the media B along the finger guide wire. After the three-lumen microcatheter reaches the intima A and the media B of the blood vessel, it will be deflected due to the force. After the deflection, the guide wire outlet in the guide wire cavity 100a of the first catheter 100 is directed towards the intima of the blood vessel. After the three-lumen microcatheter reaches the intima A and the media B of the blood vessel, the finger guide wire is withdrawn from the cavity inside the second tube body 200, and then the puncture guide wire enters the guide wire cavity 100a of the first tube body 100. The puncture guide wire punctures the intima through the guide wire outlet 121 and enters the distal end of the lesion in the true lumen of the blood vessel. After the puncture guide wire completes the puncture, the three-lumen microcatheter is withdrawn from the human body along the puncture guide wire, and the puncture guide wire will remain in the human body to assist in completing subsequent operations. During surgery, the doctor can simultaneously aspirate blood, fluid, etc. through the cavities in the third tube 300 and the first tube 100 to reduce surgery time. Of course, it is also possible to simultaneously aspirate blood, fluid, etc. through only the cavities in the third tube 300 or the first tube 100 according to surgical needs.

[0082] Why does the triple-lumen microcatheter deflect in the intramedullary space of the blood vessel? As shown in FIG14 , since the first tube body 100, the second tube body 200, and the third tube body 300 are arranged side by side in a flat shape rather than forming a circular tube, if the triple-lumen microcatheter enters the intramedullary space and is in the state shown in FIG14 , this state is unstable. This is because, on the one hand, the two tube bodies located at the uppermost and lowermost ends (relative to the state shown in FIG14 ) are in line contact with the intima A and the media B, and the upper and lower tube bodies are in contact with the intima A and the media B only along a line relative to each other. On the other hand, the intima A and the media B will apply a certain pressure (the force in the direction C shown in FIG14 and FIG15 ) to the triple-lumen microcatheter. Based on the above two reasons, the triple-lumen microcatheter will deflect, thus being in the stable state shown in FIG15 .

[0083] Furthermore, the parallel design of the first and third tubes 100 and 300 in this embodiment enhances the pushability of the three-lumen microcatheter, allowing for rapid guidewire replacement while simultaneously enabling effective puncture of the vascular endothelium using a single guidewire. Furthermore, the physician can utilize the lumen 300a within the third tube 300 to directly aspirate hematomas, reducing surgical time.

[0084] In some embodiments, referring to FIG8 , the second tube body 200 and the third tube body 300 are respectively placed on both sides of the first tube body 100 , and the distal end of the first tube body 100 is located at a more distal position than the distal ends of the second tube body 200 and the third tube body 300 . This allows the three-lumen microcatheter to pass more easily within the blood vessel, thereby improving the passing performance of the three-lumen microcatheter.

[0085] The distal ends of the second tube body 200 and the third tube body 300 are inclined surfaces, which can effectively reduce the area of ​​the distal end of the three-lumen microcatheter and further improve the passing performance of the three-lumen microcatheter in the blood vessel.

[0086] In some embodiments, a positioning body 210 may be fixed to the distal end of the first tube 100. The positioning body 210 may be a developing mark to track and locate the distal end of the second tube 200.

[0087] In some embodiments, referring to Figures 11 to 13, the distal ends of the second tube body 200, the first tube body 100, and the third tube body 300 are arranged in a stepped manner, that is, the distal ends of the second tube body 200, the first tube body 100, and the third tube body 300 are arranged obliquely, which can effectively reduce the area of ​​the distal end of the three-lumen microcatheter, making it easier for the three-lumen microcatheter to pass through the blood vessel and improving the passing performance of the three-lumen microcatheter.

[0088] Among them, the second tube body 200 and the third tube body 100 can be placed on both sides of the first tube body 100, and the distal end of the second tube body 200 is at the farthest position of the stepped arrangement (the rightmost position shown in Figures 8 to 9), or the distal end of the third tube body 300 is at the farthest position of the stepped arrangement (the rightmost position shown in Figure 12).

[0089] In some embodiments, when the distal end of the second tube 200 is at the most distal position of the stepped arrangement, the outer diameter of the distal end of the second tube 200 gradually decreases from the proximal end to the distal end. The distal ends of the first tube 100 and the third tube 300 can be inclined, that is, the tips of the guidewire lumen in the first tube 100 and the lumen in the third tube 300 are arranged in an inclined shape, to further improve the passability of the three-lumen microcatheter in the embodiment of the present application.

[0090] A positioning body 210 may be fixed to the tip portion of the distal end of the second tube 200. The positioning body 210 may be a developing mark to track and locate the distal end portion of the second tube 200.

[0091] In some embodiments, referring to Figures 11 to 13, when the distal end of the third tube body 300 is in the distalmost position of the stepped arrangement, the outer diameter of the distal end of the third tube body 300 gradually decreases from the proximal end to the distal end, and the distal ends of the first tube body 100 and the second tube body 200 are an inclined surface, that is, the guidewire cavity in the first tube body 100 and the tip of the cavity of the third tube body 300 are arranged in an inclined shape, so as to further improve the passing performance of the three-lumen microcatheter in the embodiment of the present application.

[0092] A positioning body 210 can be fixed to the distal end of the third tube 300. The positioning body can be a development mark to track and locate the distal end of the third tube 300. Preferably, the development mark can be a flexible development.

[0093] In some embodiments, the first tube body 100 also includes a stress relief tube segment 130 (within area C in Figure 8), one end of the stress relief tube segment 130 (the right end shown in Figure 8) is connected to the proximal tube segment 110, and the other end (the left end shown in Figure 8) is used to connect to the catheter seat 500, and the stress relief tube segment 130, the proximal tube segment 110 and the distal tube segment 120 are connected to form a guidewire cavity.

[0094] In some embodiments, the stress relief tube section 130 may be made of polyester elastomer materials, and the catheter seat 500 may be made of resin materials such as polycarbonate.

[0095] In this embodiment, the rear end of the OTW lumen within first tube body 100 docks with catheter adapter 500, facilitating guidewire exchange, reagent injection, hematoma aspiration, and connection to other instruments. Furthermore, a stress relief segment 130 transitions between the proximal end of the OTW lumen and catheter adapter 500 to prevent bending caused by stress concentration.

[0096] The hardness of the stress relief tube section 130 , the proximal tube section 110 and the distal tube section 120 gradually decreases, thereby ensuring overall pushability while preventing damage to tissues such as blood vessels.

[0097] In some embodiments, the third tube body 300 also includes a stress relief tube body 330 (the part of the third tube body 300 placed in area C in Figure 11), one end of the stress relief tube body 330 (the right end shown in Figure 11) is connected to the proximal tube body 310, and the other end of the stress relief tube body 330 (the left end shown in Figure 11) is used to connect to the catheter seat 600, and the internal spaces of the stress relief tube body 330, the proximal tube body 310 and the distal tube body 320 are connected to form a suction cavity.

[0098] The stress relief tube body 330 may be made of polyester elastomer materials, and the catheter seat 600 may be made of resin materials such as polycarbonate.

[0099] In this embodiment, the rear end of the OTW lumen within third tube 300 docks with catheter adapter 600, facilitating guidewire exchange, reagent injection, hematoma aspiration, and connection to other instruments. Furthermore, a stress relief tube segment 330 transitions between the proximal end of the OTW lumen and catheter adapter 600 to prevent bending caused by stress concentration.

[0100] The hardness of the stress relief tube 330 , the proximal tube 310 and the distal tube 320 of the third tube 300 gradually decreases, thereby ensuring overall pushability while preventing damage to tissues such as blood vessels.

[0101] The first tube 100 can be used for running a puncture guidewire and can also be used for aspirating edema, blood clots, fluids, etc. During surgery, the first tube 100 and the third tube 300 can simultaneously aspirate edema, blood clots, etc., which can further reduce the operation time.

[0102] Referring to Figure 16 , the OTW lumen of the first tube body 100 can be a three-layer design, comprising an outer tube layer 140, a middle reinforcement layer 150, and a smooth inner layer 160. This can be used for guiding a puncture guidewire and aspirating hematomas and fluids. The rapid exchange lumen of the second tube body 200 can be a two-layer design, comprising an outer layer 220 and an inner layer 230, facilitating the insertion and removal of instruments and saving surgical time. The third tube body 300 includes an outer layer 340 and an inner layer 350. The inner layer can be made of PTFE (Poly tetrafluoroethylene) or other smooth resin materials, while the middle reinforcement layer can be constructed of a metal braid and / or metal spring structure.

[0103] In this embodiment, even when the three-lumen microcatheter is not in a good position after being inserted, that is, the guidewire outlet 121 is not facing the vascular endothelium A, and there is a certain deviation, because it is a three-tube setting and the first tube body 100 has a reinforcing layer (spring and / or braided layer), the three-lumen microcatheter can be properly twisted to make the guidewire outlet 121 face the endothelium A, thereby improving the success rate of the puncture guidewire returning to the true lumen of the blood vessel, thereby increasing the success rate of the one-time operation to the greatest extent possible.

[0104] The embodiments of the present application have been described above. The above description is illustrative and not exhaustive, and is not limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, their practical applications, or improvements to the technology in the market, or to enable other persons skilled in the art to understand the embodiments disclosed herein.

Claims

1. A three-lumen microcatheter, characterized in that: include: a first tubular body, wherein a guidewire cavity is formed in the first tubular body; second tube body; third tube body; At least one guidewire outlet is formed on the side wall of the distal end of the first tube, and the guidewire outlet is communicated with the guidewire cavity; The second tube body is arranged in parallel with the distal end portion of the first tube body and the distal end portion of the third tube body in a flat shape, so that when the three-lumen microcatheter enters the intramedullary space of the blood vessel, at least one of the guidewire outlets faces the intima and / or media of the blood vessel; Positioning mark: the second tube body and / or the third tube body is provided with the positioning mark.

2. The three-lumen microcatheter according to claim 1, characterized in that: The axes of the first tube body, the second tube body and the third tube body are parallel, and the first tube body, the second tube body and the third tube body are located in the same plane.

3. The three-lumen microcatheter according to claim 2, characterized in that: There are two guidewire outlets, and the two guidewire outlets are opened on opposite side walls of the first tube body, and the axes of the two guidewire outlets are perpendicular to the plane.

4. The three-lumen microcatheter according to claim 3, characterized in that: The two guidewire outlets are spaced apart in the axial direction of the first tube body, and the positioning mark is arranged opposite to the area between the two guidewire outlets.

5. The three-lumen microcatheter according to claim 1, characterized in that: The positioning mark includes: a first developing mark, provided on the second tube body; The second development mark is provided on the third tube body. The first development mark and the second development mark correspond to the guide wire outlet. The first development mark and the second development mark cooperate to locate the guide wire outlet.

6. The three-lumen microcatheter according to claim 5, characterized in that: The first developing mark and the second developing mark are symmetrically arranged relative to the first tube body.

7. The three-lumen microcatheter according to claim 1, characterized in that: The positioning mark is a developing mark ring or a developing mark wire.

8. The three-lumen microcatheter according to claim 1, characterized in that: The first tube body comprises a proximal tube segment and a distal tube segment connected to each other, and the guide wire outlet is located on the side wall of the distal tube segment; The third tube body includes a proximal tube body and a distal tube body connected to each other. The proximal tube body and the proximal tube section are arranged in parallel, and the distal tube body, the distal tube section and the second tube body are arranged in parallel in a flat shape.

9. The three-lumen microcatheter according to claim 8, characterized in that: The distal ends of the first tube body, the second tube body and the third tube body are arranged in a stepped manner.

10. The three-lumen microcatheter according to claim 9, characterized in that: The second tube body and the third tube body are placed on both sides of the first tube body, and the distal end of the second tube body is at the farthest end position of the stepped arrangement, or the distal end of the third tube body is at the farthest end position of the stepped arrangement.

11. The three-lumen microcatheter according to claim 10, characterized in that: When the distal end of the second tube is at the distalmost position of the stepped arrangement, the cross-section of the distal end of the second tube gradually decreases from the proximal end to the distal end, and the distal ends of the first tube and the third tube are inclined surfaces; or When the distal end of the third tube is at the distalmost position of the stepped arrangement, the cross-section of the distal end of the third tube gradually becomes smaller in the direction from the proximal end to the distal end, and the distal ends of the first tube and the second tube are inclined surfaces.

12. The three-lumen microcatheter according to claim 8, characterized in that: The second tube body and the third tube body are respectively placed on both sides of the first tube body, and the distal end of the first tube body protrudes beyond the distal ends of the second tube body and the third tube body.

13. The three-lumen microcatheter according to claims 8-12, characterized in that: The first tube body further includes a stress relief tube segment, one end of the stress relief tube segment is connected to the proximal tube segment, and the other end is used to connect to the catheter seat, and the internal spaces of the stress relief tube segment, the proximal tube segment and the distal tube segment are connected to form the guidewire cavity; and / or The third tube body also includes a stress relief tube body, one end of which is connected to the proximal tube body, and the other end is used to connect to the catheter seat. The internal spaces of the stress relief tube body, the proximal tube body and the distal tube body are connected to form the cavity.

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