Bending-adjustable alcohol ablation guiding catheter system

Abstract

The invention discloses a bending-adjustable alcohol ablation guiding catheter system, and belongs to the technical field of interventional medical instruments. The device comprises a guiding catheter, one end of the guiding catheter is connected with a handle, the axial hollow position of the guiding catheter serves as a first channel, the handle is provided with a catheter channel communicated with the first channel, the other end of the guiding catheter is provided with a first bending adjusting section, and the handle is provided with a first bending adjusting mechanism for controlling the first bending adjusting section. The guiding catheter is provided with a second bending adjusting section, the second bending adjusting section is adjacent to the first bending adjusting section, and the handle is provided with a second bending adjusting mechanism for controlling the second bending adjusting section. The guiding catheter can enter the coronary sinus orifice quickly and accurately, the guide wire can be controlled to enter the Marshall vein, and the guiding catheter has the advantages of being simple in structure, reasonable in design and easy to manufacture.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of interventional medical instruments, and more particularly relates to a guide catheter system for adjustable bending alcohol ablation. BACKGROUND

[0002] Atrial fibrillation is the most common tachyarrhythmia in clinical practice, and the main treatment method at present is catheter ablation. The biggest difficulty in the field of atrial fibrillation ablation is that the extra-pulmonary vein driving focus cannot be completely destroyed. Marshall vein (ligament) and its accessory structures are one of the important origins of extra-pulmonary vein driving focus.

[0003] Marshall vein alcohol ablation has good feasibility and safety, can realize rapid ablation of left atrial tissue, autonomic nerves and epicardial myocardium maintaining mitral valve isthmus flutter (PMF), and improve the success rate of persistent atrial fibrillation ablation. In recent years, it has become one of the popular technologies with high attention in the treatment of persistent atrial fibrillation by catheter ablation.

[0004] There are two operation pain points in the Marshall vein alcohol ablation treatment method. One is that the guide catheter enters the coronary sinus ostium from the inferior vena cava through the atrium. Since the coronary sinus ostium is located on the atrial wall, the guide catheter needs to be bent at a certain angle when entering the coronary sinus ostium from the inferior vena cava, as shown in FIG. 1. The other is that after the guide catheter enters the coronary sinus ostium, it is pushed along the coronary vein to the Marshall vein ostium, and the guide wire enters the Marshall vein for alcohol ablation under the guidance of the guide catheter. Since the Marshall vein is a branch of the coronary vein, the Marshall vein ostium is located on the wall of the coronary vein, and the top opening of the conventional guide catheter is difficult to be as shown in FIG. 2, which can create good conditions for the guide wire to enter the Marshall vein. Figure 1 Figure 2

[0005] ​​Currently, in the operation of Marshall vein absolute alcohol ablation treatment, the location of the coronary sinus ostium and the opening location and direction of the Marshall vein are determined according to the results of preoperative heart and coronary vein angiography, and then the middle and top parts of the guide catheter are pre-shaped to form a certain angle, which is beneficial to the entry of the guide catheter into the coronary sinus ostium and the control of the guide wire direction, so that the guide wire can enter the Marshall vein. However, with the passage of time of the guide catheter and the increase of the blood temperature in the environment where the guide catheter is located, the pre-shaped angle will change. Moreover, the planar angiographic results often have certain differences with the three-dimensional actual anatomical structure. The above factors cause the operator to need to repeatedly pull and insert the guide catheter for external shaping, which increases the operation time and the fluoroscopy time, and moreover, the multiple entry attempts increase the risk of the guide catheter puncturing the atrial wall and the coronary vein wall and the guide wire puncturing the Marshall vein wall, thereby increasing the risk of thrombosis and vein dissection during the operation, which causes serious consequences of operation failure.

[0006] The prior art disclosed in Chinese Patent Document Publication No. CN221450736U discloses a Marshall vein absolute alcohol ablation special catheter, which can quickly enter various different left atrial sizes, different European ridge heights, different coronary vein openings and different running coronary vein vessels to play a good anchoring blood vessel role. However, when facing the variability of the heart anatomical structure such as Figure 3 , even if the curvature is adjusted to align the front end of the alcohol ablation special catheter with the coronary sinus ostium, further insertion of the alcohol ablation special catheter will not enter the coronary sinus ostium, but will move to the dashed line position in Figure 3 , making it difficult to enter the coronary sinus ostium and still needing repeated external shaping attempts. Moreover, the special catheter can only align the catheter side hole (guide wire outlet) with the Marshall vein vessel opening, and cannot control the running direction of the guide wire, especially when facing various Marshall vein variability anatomical structures such as Figure 4 , such as the bifurcated type (branching near the Marshall vein ostium, as shown in Figure 4 b), the lateral type (the blood flow direction of the Marshall vein is obtuse with the blood flow direction of the coronary vein, as shown in Figure 4 c) or the downward type (the blood flow direction of the Marshall vein is close to parallel with the blood flow direction of the coronary vein, as shown in Figure 4 d), the guide wire cannot be accurately controlled to penetrate deep into the Marshall vein. In special cases, even if the opening direction of the catheter side hole is coaxially aligned with the opening direction of the Marshall vein, due to the certain distance between the catheter side hole and the Marshall vein opening, the front end curved guide wire will protrude from the gap between the catheter side hole and the Marshall vein opening, as shown in Figure 5As shown. Even repeated attempts, still lead to the guide wire into the Marshall vein failure.

[0007] Therefore, in the face of the various variability of the heart and Marshall vein anatomy, the technical problem of the guide catheter cannot quickly and accurately enter the coronary sinus ostium and control the guide wire into the Marshall vein, the need to develop a new Marshall vein alcohol ablation catheter. SUMMARY

[0008] 1. Problem to be solved

[0009] In the prior art, in the face of the various variability of the heart and Marshall vein anatomy, the technical problem of the guide catheter cannot quickly and accurately enter the coronary sinus ostium and control the guide wire into the Marshall vein, the present application provides a adjustable bending alcohol ablation guide catheter system, through the synergistic effect of two-stage bending, reduce the difficulty of guide catheter into the coronary sinus ostium and control the guide wire into the Marshall vein, improve the success rate of Marshall vein alcohol ablation surgery.

[0010] 2. Technical scheme

[0011] In order to solve the above problems, the technical scheme adopted by the present application is as follows:

[0012] An adjustable bending alcohol ablation guide catheter system, comprising a guide catheter, one end of the guide catheter is connected with a handle, the axial hollow of the guide catheter is as a first channel, the handle is provided with a catheter channel communicating with the first channel, the other end of the guide catheter is provided with a first bending section, the handle is provided with a first bending mechanism for controlling the first bending section, the guide catheter is provided with a second bending section, the second bending section is adjacent to the first bending section, the handle is provided with a second bending mechanism for controlling the second bending section, the adjustable bending alcohol ablation guide catheter system controls the first bending section and the second bending section in coordination to pass through and guide under various variability of the anatomical structure.

[0013] Further, the guide catheter is provided with a second channel, a third channel and a fourth channel axially parallel to the first channel, the second channel and the third channel are radially symmetrically arranged;

[0014] The first bending mechanism is a sliding block A and a sliding block B, the peripheral surface of the handle is symmetrically provided with a sliding rail A and a sliding rail B, the sliding block A and the sliding block B respectively slide in the sliding rail A and the sliding rail B along the handle axial direction, the second bending mechanism is a ring-shaped sliding block, the ring-shaped sliding block slides along the handle axial direction;

[0015] The fourth channel is provided with a first traction line, one end of the first traction line is fixed at the junction of the first bending section and the second bending section, the other end of the first traction line is fixed on the annular slider, the second channel is provided with a second traction line, one end of the second traction line is fixed at the end of the other end of the guide catheter, the other end of the second traction line is fixed on the slider A, the third channel is provided with a third traction line, one end of the third traction line is fixed at the end of the other end of the guide catheter, the other end of the third traction line is fixed on the slider B.

[0016] Further, the inner wall of the first channel in the region of the first bending section is embedded with a snake joint skeleton.

[0017] Further, the single joint length of the snake joint skeleton 18 is 0.4-0.9mm, the moving gap is 0.05-0.2mm, and the average hollow rate is 50%-70%.

[0018] Further, the hollow rate of one end of the snake joint skeleton 18 located at the junction of the first bending section 3 and the second bending section 4 is 45%-55%, and the hollow rate of the other end is 65%-75%, and the hollow rate of the snake joint skeleton 18 gradually increases from one end to the other end.

[0019] Further, the inner wall of the first channel in the region of the second bending section is embedded with a spiral skeleton.

[0020] Further, the material of the spiral skeleton is nickel-titanium alloy, the pitch is 0.1mm-0.5mm, and the pitch of the spiral skeleton gradually decreases from one end to the other end located at the junction of the first bending section and the second bending section.

[0021] Further, the second channel and the third channel are embedded with copper wire solenoid coils in the inner wall of the region of the first bending section and the second bending section, and the fourth channel is embedded with copper wire solenoid coils in the inner wall of the region of the second bending section.

[0022] Further, the second channel, the third channel and the fourth channel are uniformly provided with annular protrusions on the inner wall surface in the region of the main section, and the cross section of the annular protrusion is rectangular. The remaining part of the guide catheter except the first bending section and the second bending section is the main section.

[0023] Further, the ring-shaped sliding block is arranged outside the guide catheter, a sliding cylinder is arranged between the guide catheter and the ring-shaped sliding block, the sliding cylinder is arranged outside the guide catheter, the sliding cylinder is fixedly connected with the handle, a limiting ring is arranged on the sliding cylinder, the ring-shaped sliding block axially slides between the limiting ring and the handle, a through hole is arranged on the sliding cylinder, a groove is arranged on the guide catheter at a position corresponding to the through hole, and the first traction line is fixedly connected with the ring-shaped sliding block in sequence through the groove and the through hole.

[0024] Further, the handle is provided with a locking structure, the locking structure comprises a pressing block, a knob and a screw connecting the two, the traction line is located between the pressing block and the channel wall, and the distance between the pressing block and the corresponding channel wall is adjusted by rotating the knob to change the degree of extrusion of the traction line by the pressing block.

[0025] Further, the catheter channel is provided with a closing cover, the catheter channel is connected with a hose channel, the hose channel is connected with the catheter channel in a Y shape, and a luer joint is connected to the other end of the hose channel.

[0026] 3. Beneficial effects

[0027] Compared with the prior art, the beneficial effects of the present application are:

[0028] (1) The adjustable bending alcohol ablation guide catheter system can realize the quick and accurate entry of the guide catheter into the coronary sinus ostium and the control of the guide wire into the Marshall vein. Figure 18 By mainly adjusting the second bending section, the advancing direction of the guide catheter in the atrium is changed at a large angle, and the bending degree of the first bending section is finely adjusted to find a suitable angle to enter the coronary sinus ostium, so that in the case of high opening of the coronary sinus, atrial hypertrophy or other special anatomic structures of the atrium, the guide catheter can be quickly and accurately guided into the coronary vein, the operation time is saved, and the intraoperative risk is reduced. At the same time, by mainly adjusting the bending degree of the first bending section and finely adjusting the bending degree of the second bending section, the Marshall vein opening of normal and tree type, downward type or lateral type anatomic variations can be actively fitted, especially for the lateral type anatomic variation of the Marshall vein opening, as shown in Figure 20 The front end of the guide catheter is reversely bent, so that the advancing direction of the guide wire is consistent with the running direction of the Marshall vein, and the passing rate of the guide wire is greatly improved.

[0029] (2) The adjustable bending alcohol ablation guide catheter system can improve the super selection state of the guide catheter to the Marshall vein opening. Figure 20As shown, on the basis of ensuring that the advancing direction of the guide wire controlled by the guide catheter end opening is consistent with the running direction of the Marshall vein, the bending degree of the second bending section can be further adjusted in coordination, so that the first bending section is "raised" as a whole, the distance between the guide catheter top opening and the Marshall vein opening is shortened, and even the state of complete matching of the guide catheter top opening and the Marshall vein opening can be achieved, so as to avoid the situation shown in Figure 19 and similar to the situation shown in Figure 5 , so as to cause the guide wire to fail to enter the Marshall vein opening. When the advancing direction of the guide wire controlled by the guide catheter top opening is consistent with the running direction of the Marshall vein, and the top opening is basically matched with the Marshall vein opening, the guide catheter realizes super selection of the Marshall vein opening.

[0030] (3) The adjustable bending alcohol ablation guide catheter system can improve the stability of the guide wire pushing. By adjusting the bending degree of the second bending section, the bending part of the first bending section of the guide catheter is close to the wall of the coronary sinus, and the bending degree of the first bending section is adjusted in coordination to form a "barb-shaped" structure. In the state of ensuring that the guide catheter end opening super selects the Marshall vein opening, the active anchoring of the guide catheter end opening to the Marshall vein opening is realized by using the reaction force of the coronary vein wall, so as to increase the axial stability of the guide catheter end opening to the Marshall vein opening during the guide wire pushing, and facilitate the rapid entry of the guide wire into the Marshall vein.

[0031] (4) The adjustable bending alcohol ablation guide catheter system can break through the acute angle obstacle formed by the Marshall vein opening and the coronary vein. The first bending section of the adjustable bending alcohol ablation guide catheter system has a large-angle bidirectional bending capability. By adjusting the bending degree of the second bending section in coordination, a flexible large-angle compound bending can be formed at the end of the guide catheter away from the handle. This active and controlled compound bending can effectively cross the acute angle obstacle, so that the top opening of the guide catheter is accurately axially aligned with the entrance of the Marshall vein, and a smooth entering path is established for the guide wire.

[0032] (5) The adjustable bending alcohol ablation guide catheter system of the present application can control the guide wire to enter the Marshall vein across the plane. When the opening direction of the Marshall vein exceeds the preset bending plane of the preoperative image (for example, the guide catheter is preset to bend up and down, and the actual opening is left or right), the operator can rotate the handle to rotate the guide catheter by a certain angle, so that the original up-down bending plane of the guide catheter is converted into a left-right bending plane, thereby realizing the "cross-plane adaptation" of the guide catheter to the Marshall vein opening. Moreover, the adjustable bending alcohol ablation guide catheter system can be bent in real time during the operation, and the bending degree can be adjusted in a short time by pushing and pulling the sliding block and the annular sliding block, so as to avoid various intraoperative risks caused by repeated shaping of the guide catheter outside the body, and improve the success rate of catheter ablation treatment.

[0033] (6) The present application has simple structure, reasonable design, easy operation, and reduces the learning cost of the operator for the operation of Marshall vein anhydrous alcohol ablation treatment. BRIEF DESCRIPTION OF DRAWINGS

[0034] Figure 1 Schematic diagram of the guide catheter entering the ostium of the coronary sinus in the prior art;

[0035] Figure 2 Schematic diagram of the guide catheter controlling the guide wire to enter the Marshall vein in the prior art;

[0036] Figure 3 Schematic diagram of the guide catheter difficult to enter the ostium of the coronary sinus when the heart is hypertrophied;

[0037] Figure 4 :

[0038] (a) is a schematic diagram of the anatomical structure of the heart;

[0039] (b) is a schematic diagram of the anatomical structure of the tree type Marshall vein in the heart;

[0040] (c) is a schematic diagram of the anatomical structure of the lateral type Marshall vein in the heart;

[0041] (d) is a schematic diagram of the anatomical structure of the downward type Marshall vein in the heart;

[0042] Figure 5 Schematic diagram of the failure of the guide wire to enter under the non-conformable state of the side hole of the ablation special catheter and the Marshall vein opening in the prior art;

[0043] Figure 6 Schematic diagram of the structure of the adjustable bending alcohol ablation guide catheter system of the present application;

[0044] Figure 7Cross-sectional view of the guide catheter body section in the adjustable bending alcohol ablation guide catheter system of the present application;

[0045] Figure 8 A-A' cross-sectional view of a portion of the guide catheter in the adjustable bending alcohol ablation guide catheter system of the present application;

[0046] Figure 9 A-A' cross-sectional view of the first bending section of the guide catheter in the adjustable bending alcohol ablation guide catheter system of the present application;

[0047] Figure 10 A-A' cross-sectional view of the second bending section of the guide catheter in the adjustable bending alcohol ablation guide catheter system of the present application;

[0048] Figure 11 A-A' cross-sectional view of the guide catheter body section in the adjustable bending alcohol ablation guide catheter system of the present application;

[0049] Figure 12 A-B rotational cross-sectional view of the guide catheter body section in the adjustable bending alcohol ablation guide catheter system of the present application;

[0050] Figure 13 Handle structure in the adjustable bending alcohol ablation guide catheter system of the present application Figure 1 ;

[0051] Figure 14 Handle structure in the adjustable bending alcohol ablation guide catheter system of the present application Figure 2 ;

[0052] Figure 15 Handle structure in the adjustable bending alcohol ablation guide catheter system of the present application Figure 3 ;

[0053] Figure 16 Locking structure in the adjustable bending alcohol ablation guide catheter system of the present application

[0054] Figure 17 Bending adjustment of the guide catheter in the adjustable bending alcohol ablation guide catheter system of the present application

[0055] Figure 18 Entry of the guide catheter into the coronary vein in the adjustable bending alcohol ablation guide catheter system of the present application

[0056] Figure 19 Failure of the guide wire to enter in the prior art guide catheter and Marshall vein opening non-anastomosis state

[0057] Figure 20Figure 1 is a schematic diagram of a guide catheter and a Marshall vein in a superselective state.

[0058] In the figure:

[0059] 1, handle; 2, guide catheter; 3, first bending section; 4, second bending section; 5, first channel; 6, second channel; 7, third channel; 8, fourth channel; 9, slide rail A; 10, slide rail B; 11, slide block A; 12, slide block B; 13, ring-shaped slide block; 14, pulley; 15, first traction line; 16, second traction line; 17, third traction line; 18, snake joint skeleton; 19, spiral skeleton; 20, copper wire spiral; 21, ring-shaped protrusion; 22, sliding cylinder; 23, limiting ring; 24, locking structure A; 241, extrusion block; 242, knob; 243, screw rod; 25, locking structure B; 26, catheter channel; 27, closure cap; 28, hose channel; 29, luer connector; 30, developing ring; 31, stainless steel woven mesh skeleton; 32, coronary vein; 33, Marshall vein; 34, guide wire; 35, OTW balloon; 36, coating; 37, inferior vena cava; 38, coronary sinus ostium. DETAILED DESCRIPTION

[0060] It should be noted that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements can be present. Also, the use of "a" or "an" to describe elements, items or components is taken to mean one or more than one unless otherwise indicated.

[0061] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.

[0062] As used herein, the term "about" is used to provide flexibility to a given term, measurement, or value. The degree of flexibility of a particular variable will be readily determined by one of ordinary skill in the art.

[0063] As used herein, "adjacent" means close to two structures or elements. Specifically, elements identified as "adjacent" can abut or connect. Such elements can also be close or proximate to each other without necessarily touching each other. In some cases, the exact degree of closeness can depend on the particular context.

[0064] Numerical data may be presented in range format herein. It should be understood that such range format is used solely for convenience and brevity, and should be flexibly interpreted to include not only the numerical values ​​explicitly stated as the limits of the range, but also all individual numerical values ​​or subranges encompassed within the range, as if each numerical value and subrange were explicitly stated. For example, a numerical range of approximately 1 to approximately 4.5 should be interpreted to include not only the explicitly stated limits of 1 to approximately 4.5, but also individual numbers (such as 2, 3, 4) and subranges (such as 1 to 3, 2 to 4, etc.). The same principle applies to ranges that describe only a single numerical value, such as "less than approximately 4.5," which should be interpreted to include all the aforementioned values ​​and ranges. Furthermore, this interpretation should apply regardless of the breadth of the range or characteristic described.

[0065] In this application, the curvature refers to the angle between the guiding catheter in a curved state and in a straight state, such as... Figure 17 The included angle α.

[0066] The present invention will be further described below with reference to specific embodiments.

[0067] Example 1

[0068] like Figure 6 As shown, the adjustable alcohol ablation guiding catheter system of the present invention consists of two parts: a guiding catheter 2 and a handle 1. The handle 1 is cylindrical with a diameter of 25 mm and a length of 120 mm, and is made of medical ABS plastic. The handle 1 is axially hollow, and the guiding catheter 2 is located in the axially hollow part of the handle 1. The axially hollow part of the handle 1 is also provided with a catheter channel 26 and a hose channel 28. The catheter channel 26 and the hose channel 28 are connected in a Y-shaped gradient with a fusion angle of 15°. The end of the hose channel 28 is also provided with a Luer connector 29 for connecting the infusion passage of contrast agent. The end of the catheter channel 26 is provided with a sealing cap 27 for sealing the catheter channel 26 when the contrast agent is injected into the hose channel 28 to prevent the contrast agent from leaking from the opening of the catheter channel 26.

[0069] The length of the guide catheter 2 is 110 cm, which is made of high-molecular material with high strength and good biocompatibility. The end of the guide catheter 2 away from the handle 1 comprises a first bending section 3, a second bending section 4 and a main body section in sequence. The end of the guide catheter 2 away from the handle 1 is provided with a developing ring 30, that is, the end of the first bending section 3 is provided with the developing ring 30. The ring width of the developing ring 30 is 0.3 cm. The junction of the first bending section 3 and the second bending section 4 is provided with the developing ring 30, which is a platinum-tungsten alloy eccentric half ring (0.5 cm, covering 240° in the circumferential direction). The junction of the second bending section 4 and the main body section is provided with the developing ring 30, which is a platinum-iridium alloy wide ring (0.5 cm). The stress change at the corresponding position is judged by observing the morphological change of each developing ring 30 in real time under X-ray, for example, the developing ring 30 itself is twisted, deformed or irregular, which directly indicates that the point bears excessive stress. At the same time, the bending degree of the corresponding position is judged by using the relationship between the bending degree and the stress.

[0070] As shown in Figures 7-11 The first channel 5, the second channel 6, the third channel 7 and the fourth channel 8 are arranged in the guide catheter 2. The central axes of the first channel 5, the second channel 6, the third channel 7 and the fourth channel 8 are parallel to the central axis of the guide catheter 2, and the central axis of the first channel 5 coincides with the central axis of the guide catheter 2, that is, the first channel 5 is arranged at the central axis of the guide catheter 2 and penetrates through the entire guide catheter 2. The second channel 6 and the third channel 7 are symmetrically arranged on both sides of the first channel 5, and the second channel 6, the third channel 7 and the fourth channel 8 are arranged on the same diameter line.

[0071] A snake joint skeleton 18 is embedded in the inner wall of the first channel 5 in the first bending segment 3 region. The snake joint skeleton 18 is composed of a series of bone segments, which are connected by hinges or other connection methods. Each bone segment can bend around a center point. The bending operation of the snake joint skeleton 18 mainly relies on the traction line. The wall thickness of the snake joint skeleton 18 is 0.2 mm, the single segment length is 0.8 mm, and the active gap is 0.1 mm. The inner wall of the first channel 5 is also covered with a polytetrafluoroethylene coating with a thickness of 50 μm and a friction coefficient < 0.03, which is used to reduce the friction resistance of the guide wire 34 or OTW balloon 35 passing through. A spiral skeleton 19 is embedded in the inner wall of the first channel 5 in the second bending segment 4 region. The spiral skeleton 19 is a metal strip rolled into an S-shaped skeleton profile, then wound in a spiral way on the inner wall of the channel. The adjacent spiral turns are overlapped or closely arranged with each other, forming an integral support structure. The material of the spiral skeleton 19 is nickel-titanium alloy, which has certain strength and rigidity to provide radial support when the channel is bent, and also has good flexibility and elasticity, which can bend and deform with the pipe. The wire diameter of the spiral skeleton 19 is 0.2 mm, and the pitch is 0.3 mm. A stainless steel woven mesh skeleton is embedded in the inner wall of the first channel 5 in the main segment region, which provides anti-kinking performance for the main segment of the guide catheter 2 to avoid damage when the torque is transmitted to the distal end of the guide catheter 2. Copper wire solenoid coils 20 are embedded in the inner wall of the second channel 6 in the first bending segment 3 and the second bending segment 4 region. The copper wire solenoid coil 20 has the same structure as the spiral skeleton 19. The wire diameter of the copper wire solenoid coil 20 is 0.05 mm. Copper wire solenoid coils 20 are also embedded in the inner wall of the third channel 7 in the first bending segment 3 and the second bending segment 4 region. The wire diameter of the copper wire solenoid coil 20 is 0.05 mm. Copper wire solenoid coils 20 are also embedded in the inner wall of the fourth channel 8 in the second bending segment 4 region. The wire diameter of the copper wire solenoid coil 20 is 0.05 mm. Ring protrusions 21 are uniformly arranged on the inner walls of the second channel 6, the third channel 7 and the fourth channel 8 in the main segment region. The cross section of the ring protrusion 21 is rectangular, and the inner diameter of the ring protrusion 21 is 0.3 mm, which is used to limit the traction line in the inner diameter of the ring protrusion 21 for traction, reduce the contact area between the traction line and the channel, and further reduce the friction resistance. The inner walls of the second channel 6, the third channel 7 and the fourth channel 8 are also covered with a polytetrafluoroethylene coating, which is used to reduce the friction between the traction line and the channel.

[0072] As Figure 6 And Figures 13-15As shown, the handle 1 is symmetrically provided with a slide rail A 9 and a slide rail B 10 on the peripheral surface, the slide rail A 9 and the slide rail B 10 are circular rectangular, and the slide rail A 9 and the slide rail B 10 are respectively provided with a slide block A 11 and a slide block B 12 in the tracks, the slide block A 11 can slide along the axial direction of the handle 1 in the track of the slide rail A 9, and the slide block B 12 can also slide along the axial direction of the handle 1 in the track of the slide rail B 10. The handle 1 is also symmetrically provided with a locking structure A 24 and a locking structure B 25 on the peripheral surface, both of which are the same structure and include a pressing block 241, a knob 242 and a screw 243 connecting the two, by rotating the knob 242, the relative distance between the pressing block 241 and the knob 242 is changed, such as Figure 16 As shown.

[0073] The connection between the guide catheter 2 and the handle 1 is provided with a sliding cylinder 22 for fixing the connection between the guide catheter 2 and the handle 1, the sliding cylinder 22 is sleeved on the outer periphery of the guide catheter 2, and the outer periphery of the sliding cylinder 22 is also sleeved with a ring-shaped slide block 13, that is, the sliding cylinder 22 is arranged between the guide catheter 2 and the ring-shaped slide block 13. The sliding cylinder 22 is provided with a limiting ring 23, and the limiting ring 23 limits the axial sliding stroke of the ring-shaped slide block 13 along the sliding cylinder 22 to 2cm together with the handle 1, and the bending degree of the second bending section 4 is one-way 0-90°. The sliding cylinder 22 is also provided with a circular rectangular shaped through hole, which is arranged on the side of the sliding cylinder 22 closest to the fourth channel 8, and the outer wall of the fourth channel 8 is provided with a through hole with the same length at the corresponding position.

[0074] The first traction line 15 is arranged in the fourth channel 8, one end of the first traction line 15 is fixed to the end of one end of the fourth channel 8, the end of one end of the fourth channel 8 is located at the junction of the first bending section 3 and the second bending section 4, the other end of the first traction line 15 is reversely connected to the fixed column of the ring-shaped slide block 13 after passing through the pulley 14 arranged in the handle 1, and the fixed column passes through the through holes of the sliding cylinder 22 and the outer wall of the fourth channel 8 to ensure that the first traction line 15 after turning back is parallel to the main body of the first traction line 15, so as to accurately control the bending degree of the second bending section 4. The first traction line 15 is a double-twisted structure of a nickel-titanium alloy super-elastic wire with a diameter of 0.2mm and a redundant micro-wire with a diameter of 0.05mm, and the pre-tension is 200gf.

[0075] The second traction line 16 and the third traction line 17 are respectively arranged in the second channel 6 and the third channel 7, one end of the second traction line 16 is fixed to the end of the first bending section 3, i.e. the end of the guide catheter 2, and the other end of the second traction line 16 is fixed to the sliding block A11 on the handle 1. The locking structure A24 on the handle 1 is located between the annular sliding block 13 and the sliding block A11, the pressing block 241 of the locking structure A24 can contact the second traction line 16 through the through hole arranged on the outer wall of the second channel 6, the relative distance between the pressing block 241 and the knob 242 is changed by rotating the knob 242, and then the distance between the pressing block 241 and the channel wall is changed, since the second traction line 16 is located between the pressing block 241 and the channel wall, the pressing degree of the pressing block 241 to the second traction line 16 is changed, and then the second traction line 16 is kept with a fixed tension, so that the first bending section 3 maintains a fixed bending degree, and the bending degree of the first bending section 3 is one-way 0-120°. One end of the third traction line 17 is fixed to the end of the first bending section 3, i.e. the end of the guide catheter 2, and the other end of the third traction line 17 is fixed to the sliding block B12 on the handle 1. The locking structure B25 on the handle 1 is located between the annular sliding block 13 and the sliding block B12, the pressing block 241 of the locking structure B25 can contact the third traction line 17 through the through hole arranged on the outer wall of the third channel 7, and the locking structure B25 has the same effect as the locking structure A24, and the other relative one-way bending degree of the first bending section 3 is 0-120°. The second traction line 16 and the third traction line 17 are double-twisted structures of a super-elastic nickel-titanium alloy wire with a diameter of 0.15 mm and a redundant micro-wire with a diameter of 0.05 mm, and the pre-tension is 150 gf.

[0076] The guide catheter 2 is divided into three specifications of 5F, 6F and 7F according to the width of the diameter, and the inner diameter of the first channel 5 is divided into three specifications of 0.046-0.072 inches.

[0077] In use, the guide catheter 2 of appropriate size is selected and inserted through the right femoral vein into the atrium from the inferior vena cava, the length of the guide catheter 2 entering the atrium is controlled, the thumb push-pull ring-shaped slider 13 is pushed and pulled to adjust the curvature of the second bending section 4, the direction of advancement of the guide catheter in the atrium is changed at a large angle, and the curvature of the first bending section 3 is fine-tuned to enable the end of the guide catheter 2 to be aligned with the ostium of the coronary sinus 38, the guide catheter 2 is continuously inserted, and after successful entry into the coronary sinus, the infusion path of the contrast agent is connected to the hose channel 28 through the luer connector 29, and the closure cap 27 at the end of the catheter path is ensured to be closed to prevent leakage of the contrast agent from the catheter path, the Marshall vein area of the coronary sinus is imaged by injecting the contrast agent, the length of the guide catheter 2 entering the coronary sinus is adjusted according to the position and direction of the Marshall vein opening displayed after imaging, the push-pull slider A11 or the slider B12 is selected to adjust the curvature of the first bending section 3, the direction of the opening of the first bending section 3 is coaxial with the direction of the opening of the Marshall vein, and the opening of the first bending section 3 is matched with the opening of the Marshall vein, and the "super selection" state of the guide catheter 2 to the Marshall vein is achieved. If the direction of the opening of the Marshall vein is not in the same plane as the adjustable bending plane of the first bending section 3, the guide catheter 2 can be rotated as a whole and then adjusted to the "super selection" state of the Marshall vein. Then, the knob 242 of the rotation locking structure A24 or B is rotated to fix the second traction wire 16 or the third traction wire 17 between the extrusion block 241 and the inner wall of the channel, preventing the end opening of the guide catheter 2 from shifting when the guide wire 34 or the OTW balloon 35 is delivered, and improving the stability of the delivery of the guide wire 34 or the OTW balloon 35. When it is necessary to adjust the curvature of the first bending section 3 again, the knob 242 can be rotated in the opposite direction to release the tension of the traction wire. Then, the guide wire 34 is sent through the catheter channel 26 and directly enters the opening of the Marshall vein through the guide catheter 2 and quickly reaches the distal end of the Marshall vein, and then the OTW balloon 35 is sent along the guide wire 34 and enters the Marshall vein, the OTW balloon 35 is inflated and expanded to fully block the Marshall vein and anchor the blood vessel, preventing blood reflux or anhydrous alcohol reflux, the guide wire 34 is withdrawn, and anhydrous alcohol is injected into the Marshall vein through the hollow microchannel of the OTW balloon 35 to continuously damage the mitral valve and the left atrial appendage ridge area from the epicardial side, thereby intervening in the key area and related mechanism of maintaining arrhythmia such as atrial fibrillation and atrial flutter.

[0078] The development ring 30 arranged at one end of the first adjustable bending section 3 is used to determine the position and angle of the opening of the guide catheter 2 and the coaxiality with the Marshall vein opening after the contrast, so as to improve the success rate and efficiency of the guide wire 34 and the OTW balloon 35. The platinum-tungsten alloy eccentric half ring is used to dynamically display the angle and direction of the double bending of the first adjustable bending section 3 and the second adjustable bending section 4. The platinum-iridium alloy wide ring is used to position the guide catheter 2 into the depth of the coronary sinus, and monitor the bending degree and bending stress of the second adjustable bending section 4 of the guide catheter 2.

[0079] The nickel-titanium alloy spiral skeleton 19 of the second adjustable bending section 4 has super elasticity, and the bent second adjustable bending section 4 can automatically slowly recover to the original state after the traction line tension is released. The snake joint skeleton 18 of the first adjustable bending section 3 can provide greater bending angle and flexibility, and is suitable for the area that needs more precise control, and the laser cutting hollow design can reduce the weight while ensuring the strength, and increase the flexibility.

[0080] The copper wire spiral coil 20 embedded in the inner wall of the second channel 6, the third channel 7 and the fourth channel 8 can reduce the friction between the traction line of the adjustable bending section of the guide catheter 2 and the channel, and prevent the second channel 6, the third channel 7 or the fourth channel 8 from collapsing due to excessive bending of the adjustable bending section of the guide catheter 2, affecting the movement of the traction line.

[0081] The first adjustable bending section 3 realizes precise bending of the first adjustable bending section 3 through a bidirectional traction mechanism, which is beneficial to realize the "super selection" of the Marshall vein by the guide catheter 2. After the thumb pushes the annular slider 13, the middle finger or the index finger pulls the annular slider 13 to release the tension, so that the first adjustable bending section 3 automatically returns to the original state by the super elasticity of the nickel-titanium alloy spiral skeleton 19, which is convenient for the operator to complete the bending and resetting with one hand. The limiting ring 23 limits the axial sliding of the annular slider 13 along the sliding cylinder 22, which can prevent excessive traction from causing plastic deformation of the spiral skeleton 19, and avoid affecting the automatic resetting of the spiral skeleton 19. The 15° gradual fusion angle of the catheter channel 26 and the hose channel 28 can avoid the formation of turbulent flow when injecting contrast agent or anhydrous alcohol.

[0082] Embodiment 2

[0083] The difference between Embodiment 2 and Embodiment 1 is that the diameter of the guide catheter 2 is further shortened, like Figure 12As shown, the fourth channel 8 can also be arranged on a diameter line perpendicular to the diameter lines where the second channel 6 and the third channel 7 are arranged, or can be arranged at any other position. The joint hollow rate of the serpentine joint skeleton 18 of the first bending section 3 near one end of the platinum-tungsten alloy eccentric half ring is 50%, which is used to provide thrust transmission; the joint hollow rate of the other end is 70%, which enhances the flexibility of the end of the guide catheter 2, and the overall hollow rate of the serpentine joint skeleton 18 is gradually changed, thereby increasing the success rate of the guide catheter 2 in selecting the obtuse angle opening of the Marshall vein. The helical skeleton 19 of the second bending section 4 of nickel-titanium alloy is designed with gradually changing pitch, and the pitch of the helical skeleton 19 near one end of the platinum-tungsten alloy eccentric half ring is 0.4 mm, and the pitch of the other end is 0.2 mm, which realizes the incremental bending stiffness, ensures the flexible follow-up of one end and the stable support of the other end.

[0084] The second bending section 4 is respectively provided with a damping step on the slide cylinder 22 when the bending degree is 15°, 30°, 45°, 60° and 75°, so as to provide tactile feedback and facilitate the surgeon to "blindly" perceive the bending degree of the second bending section 4. Similarly, the first bending section 3 is respectively provided with a tactile damping point on the slide rail when the bending degree is 30°, 60° and 90°, and the surgeon can perceive the key angle through the resistance change. The surface of the slide block (A; B) is covered with silica gel anti-slip particles (diameter 0.5 mm), and the friction coefficient is >0.6, which ensures the stability of the operation of the surgeon with wet hands.

[0085] The above is a schematic description of the present application and its embodiments, which is not restrictive, and the embodiments shown in the examples are only one of the embodiments of the present application, and the actual embodiments are not limited thereto. Therefore, if a person skilled in the art is inspired thereby, without departing from the purpose of the present application, similar embodiments and examples of the technical solution can be designed without creativity, which shall belong to the protection scope of the present application.

Claims

1. An adjustable bending alcohol ablation guide catheter system, comprising a guide catheter (2), one end of the guide catheter (2) is connected with a handle (1), the axial hollow of the guide catheter (2) is used as a first channel (5), the handle (1) is provided with a catheter channel (26) in communication with the first channel (5), the other end of the guide catheter (2) is provided with a first bending section (3), the handle (1) is provided with a first bending mechanism for controlling the first bending section (3), characterized in that, The guide catheter (2) is provided with a second bending section (4) adjacent to the first bending section (3), and the handle (1) is provided with a second bending mechanism for controlling the second bending section (4).

2. The adjustable bending alcohol ablation guide catheter system according to claim 1, characterized in that, The guide catheter (2) is provided with a second channel (6), a third channel (7) and a fourth channel (8) axially parallel to the first channel (5), and the second channel (6) and the third channel (7) are radially symmetrically arranged; The first bending mechanism is a sliding block A (11) and a sliding block B (12), and the handle (1) is symmetrically provided with a sliding rail A (9) and a sliding rail B (10) on the peripheral surface, and the sliding block A (11) and the sliding block B (12) respectively slide in the sliding rail A (9) and the sliding rail B (10) along the axial direction of the handle (1), and the second bending mechanism is a ring-shaped sliding block (13) which slides in the axial direction of the handle (1); The fourth channel (8) is provided with a first traction line (15), one end of the first traction line (15) is fixed at the junction of the first bending section (3) and the second bending section (4), and the other end of the first traction line (15) is fixed on the ring-shaped sliding block (13), the second channel (6) is provided with a second traction line (16), one end of the second traction line (16) is fixed at the end of the other end of the guide catheter (2), and the other end of the second traction line (16) is fixed on the sliding block A (11), the third channel (7) is provided with a third traction line (17), one end of the third traction line (17) is fixed at the end of the other end of the guide catheter (2), and the other end of the third traction line (17) is fixed on the sliding block B (12).

3. The adjustable bend alcohol ablation guide catheter system of claim 2, wherein, The first channel (5) is embedded with a snake joint skeleton (18) on the inner wall of the region of the first bending section (3).

4. The adjustable bend alcohol ablation guide catheter system of claim 3, wherein, The single joint length of the snake joint skeleton (18) is 0.4-0.9mm, the moving clearance is 0.05-0.2mm, and the average hollow rate is 50%-70%.

5. The adjustable bend alcohol ablation guide catheter system of claim 4, wherein, The hollow rate of one end of the snake joint skeleton (18) located at the junction of the first bending section (3) and the second bending section (4) is 45%-55%, and the hollow rate of the other end is 65%-75%, and the hollow rate gradually increases from one end to the other end of the snake joint skeleton (18).

6. The adjustable bend alcohol ablation guide catheter system of claim 2, wherein, The first channel (5) is embedded with a spiral skeleton (19) on the inner wall of the region of the second bending section (4).

7. The adjustable bend alcohol ablation guide catheter system of claim 6, wherein, The material of the spiral skeleton (19) is nickel-titanium alloy, and the pitch is 0.1mm-0.5mm, and the pitch of the spiral skeleton (19) gradually decreases from one end to the other end of the spiral skeleton (19) located at the junction of the first bending section (3) and the second bending section (4).

8. The adjustable bend alcohol ablation guide catheter system of claim 2, wherein, The inner wall of the area of the first tuning section (3) and the second tuning section (4) of the second channel (6) and the third channel (7) is embedded with a copper wire spiral coil (20), and the inner wall of the area of the second tuning section (4) of the fourth channel (8) is embedded with a copper wire spiral coil (20).

9. The adjustable bend alcohol ablation guide catheter system of any of claims 2-8, wherein, The inner wall surface of the second channel (6), the third channel (7) and the fourth channel (8) in the main body section area is uniformly provided with annular protrusions (21), and the cross section of the annular protrusions (21) is rectangular.

10. The adjustable bend alcohol ablation guide catheter system of claim 2, wherein, The ring-shaped sliding block (13) is sleeved outside the finger guide tube (2), a sliding cylinder (22) is arranged between the finger guide tube (2) and the ring-shaped sliding block (13), the sliding cylinder (22) is sleeved outside the finger guide tube (2), the sliding cylinder (22) is fixedly connected with the handle (1), a limiting ring (23) is arranged on the sliding cylinder (22), the ring-shaped sliding block (13) axially slides between the limiting ring (23) and the handle (1), a through hole is arranged on the sliding cylinder (22), a groove is arranged on the finger guide tube (2) at the corresponding position of the through hole, and the first traction line (15) is fixedly connected with the ring-shaped sliding block (13) by sequentially penetrating through the groove and the through hole.

11. The adjustable bend alcohol ablation guide catheter system of claim 10, wherein, The handle (1) is provided with a locking structure, the locking structure includes a pressing block (241), a knob (242) and a screw (243) connecting the two, the traction line is located between the pressing block (241) and the channel wall, the distance between the pressing block (241) and the corresponding channel wall is adjusted by rotating the knob (242), and the degree of extrusion of the pressing block (241) on the traction line is changed.

12. The adjustable bend alcohol ablation guide catheter system of claim 11, wherein, The catheter channel (26) is provided with a closed cover (27), the catheter channel (26) is connected with a hose channel (28), the hose channel (28) is connected with the catheter channel (26) in a Y shape, and the other end of the hose channel (28) is connected with a luer joint (29).

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