Three-dimensional far-end coronary vein mapping catheter

Abstract

The invention discloses a three-dimensional far-end coronary vein mapping catheter which comprises a main mapping catheter and an auxiliary mapping catheter. The mapping main catheter sequentially comprises a main catheter body, an adjustable bent handle device, a first connector and a Luer taper from the far end to the near end. The far end of the main catheter body is bent in a normal state; the outer diameter of the auxiliary catheter body is smaller than or equal to the diameter of the catheter through cavity, a mapping section is arranged at the far end of the auxiliary catheter body, a second end electrode is arranged at the tip of the far end of the mapping section, a second magnetic positioning sensor is arranged in the mapping section, and the second end electrode and the second magnetic positioning sensor are electrically connected with the second connector through the branching connector and the wires respectively. Compared with the prior art, far-end coronary veins can be modeled, coronary vein information of a patient can be detected more meticulously, rapid diagnosis is facilitated, multiple functions are achieved through one catheter, the number of catheters entering the body of the patient is reduced, operation operability is enhanced, meanwhile, the burden of the patient is reduced, and operation time is saved.

Description

Technical Field

[0001] The invention relates to a medical device, in particular to a three-dimensional distal coronary vein mapping catheter for mapping and modeling coronary veins and distal ends of coronary veins. Background Art

[0002] Since the 1970s, people first realized that coronary veins may play an important role in identifying certain arrhythmias. In the following period, the research on coronary vein mapping has ushered in rapid development. Due to the special location of coronary veins, coronary vein mapping currently plays an important role in guiding radiofrequency ablation treatment of complex atrial fibrillation and ventricular arrhythmias. Coronary vein mapping can quickly confirm the targets of certain diseases and guide treatment. For example, in the diagnosis and treatment of ventricular arrhythmias, ectopic pacemakers originating from the epicardium or outflow tract can be identified by mapping the coronary veins and their distal ends, thereby guiding radiofrequency ablation. Coronary vein mapping also plays an important role in the diagnosis and treatment of heart diseases such as atrial fibrillation, atrial flutter, and supraventricular tachycardia. With the introduction of three-dimensional mapping technology, through real-time positioning of the catheter and modeling of the cardiac cavity structure, it helps the surgeon to better observe the state of the heart, reduce the difficulty of identification, shorten the X-ray exposure time, and make the operation process efficient, safe, and fast. Summary of the invention

[0003] The purpose of the present invention is to provide a three-dimensional distal coronary vein mapping catheter. The technical problem to be solved is to realize the function of mapping, modeling and positioning the coronary vein and the distal end of the coronary vein, improve the efficiency of mapping, reduce the difficulty of surgery, and shorten the operation time.

[0004] To solve the above problems, the present invention adopts the following technical solutions: a three-dimensional distal coronary vein mapping catheter, including a mapping main catheter and a mapping auxiliary catheter;

[0005] The main mapping catheter comprises, from the distal end to the proximal end, a main catheter body, an adjustable curved handle device, a first connector, and a Luer connector;

[0006] The distal end of the main catheter body is bent in a normal state to form an arc segment. The proximal end of the main catheter body is connected to an adjustable bending handle device so that the arc segment is completely bent and deformed under the drive of the adjustable bending handle device. The main catheter body has a catheter through cavity, which runs through the main catheter body. A first end electrode is provided on the distal end of the arc segment, and first ring electrodes are arranged at intervals on the arc segment. The first end electrode and the first ring electrode are electrically connected to the first connector through a wire. A first magnetic positioning sensor is provided in the arc segment, and the first magnetic positioning sensor is electrically connected to the first connector through a wire. The distal end of the Luer connector is connected to the proximal end of the main catheter body.

[0007] The mapping auxiliary catheter comprises an auxiliary catheter body, a branching connector, and a second connector in sequence from the distal end to the proximal end;

[0008] The outer diameter of the auxiliary catheter body is less than or equal to the diameter of the catheter lumen. A mapping section is provided at the distal end of the auxiliary catheter body. A second end electrode is provided on the distal end of the mapping section. A second magnetic positioning sensor is provided in the mapping section. The second end electrode and the second magnetic positioning sensor are electrically connected to the second connector through wires and a branching joint.

[0009] Furthermore, after the arc segment is completely curled and deformed, the proximal end and the distal end of the arc segment are not on the same spatial plane.

[0010] Furthermore, the arc segment is provided with three lumens, namely a wire lumen, a pull wire lumen, and a through hole lumen. The three lumens are all connected to the catheter lumen. The wires of the first end electrode, the first ring electrode, and the first magnetic positioning sensor pass through the wire lumen and then through the catheter lumen to be electrically connected to the first connector.

[0011] Furthermore, the first end electrode is annular, and a central opening thereof is communicated with the catheter lumen.

[0012] Furthermore, the through hole lumen is located at the center of the arc segment and is arranged on the same axis as the catheter lumen.

[0013] Furthermore, there are at least three first ring electrodes.

[0014] Furthermore, a hose is provided in the catheter lumen, the distal end of the hose passes through the through-hole lumen and is inserted into the opening of the first end electrode, and the proximal end passes through the adjustable curved handle device and is connected to the Luer connector.

[0015] Furthermore, a grid layer is provided in the main pipe body except the arc-shaped section.

[0016] Furthermore, a second ring electrode is provided on the mapping section, and the second ring electrode is electrically connected to the second connector through a wire through a branching joint.

[0017] Compared with the prior art, the present invention has a main mapping catheter with a special spatial curved structure (curved arc segment), which can quickly enter the coronary sinus for modeling and mapping by virtue of its own structural advantages. When it is necessary to map the distal coronary vein, the mapping auxiliary catheter is extended from the catheter lumen reserved in the mapping main catheter to map the distal coronary vein. At the same time, since the mapping auxiliary catheter also has a three-dimensional mapping function, it can model the distal coronary vein, and more carefully detect the patient's coronary vein information, which is helpful for rapid diagnosis. Multiple functions can be achieved through one catheter, which reduces the number of catheters entering the patient's body, enhances the operability of the operation, reduces the burden on the patient, and saves operation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a structural schematic diagram of the main catheter for mapping of the present invention.

[0019] Figure 2 This is a schematic diagram of the structure of the arc segment of the present invention in a straight line state.

[0020] Figure 3 Schematic diagram of the structure of the first terminal electrode of the present invention

[0021] Figure 4 It is a schematic diagram of the structure of the catheter body of the present invention after being bent.

[0022] Figure 5 yes Figure 4 Schematic diagram of the center C direction.

[0023] Figure 6 It is a schematic diagram of the arc segment of the present invention in a natural state.

[0024] Figure 7 It is a schematic diagram of the present invention after the arc segment is pulled and curled.

[0025] Figure 8 It is a schematic diagram of the internal structure of the arc segment of the present invention.

[0026] Fig. 9 It is an axial cross-sectional view of the main pipe body of the present invention.

[0027] Fig.10 It is a structural schematic diagram of the adjustable curved handle device of the present invention.

[0028] Fig.11 It is a schematic diagram of the structure of the auxiliary mapping catheter of the present invention.

[0029] Fig.12 It is a structural schematic diagram of the mapping section of the present invention.

[0030] Fig.13 It is a schematic diagram of the auxiliary mapping catheter of the present invention extending from the main mapping catheter.

[0031] Fig.14 It is a partial schematic diagram of the auxiliary mapping catheter of the present invention extending from the main mapping catheter. DETAILED DESCRIPTION

[0032] The present invention is further described in detail below with reference to the accompanying drawings and embodiments.

[0033] In the present invention, the distal end refers to the end away from the surgical operator; the proximal end refers to the end close to the surgical operator.

[0034] like Figure 1 , Fig.11 and Fig.13As shown, the present invention discloses a three-dimensional distal coronary vein mapping catheter, including a main mapping catheter 1 and a secondary mapping catheter 2. The main mapping catheter 1 and the secondary mapping catheter 2 are described in detail below.

[0035] like Figure 1 , Figure 2 , Figure 4 and Figure 6 As shown, the main mapping catheter 1 includes, from the distal end to the proximal end, a main catheter body 11, an adjustable curved handle device 12, a first connector 13, and a Luer connector 14. In the present invention, the adjustable curved handle device 12 and the Luer connector 14 adopt the existing technology and are not described in detail herein.

[0036] The distal end of the main conduit body 11 is normally curved to form an arc segment 1110 ( Figure 6 As shown in the figure, a wire drawing wire 111 is provided in the main catheter body 11, the distal end of the wire drawing wire 111 is connected to the distal end of the arc segment 1110, and the proximal end passes through the main catheter body 11 and is connected to the wire fixing column 121 in the adjustable curved handle device 12, the main catheter body 11 has a catheter through cavity 112, and the catheter through cavity 112 runs through the main catheter body 11, a first end electrode 113 is provided on the distal end of the arc segment 1110, and a first ring electrode 113 is provided on the arc segment 1110 at intervals. 4. The first end electrode 113 and the first ring electrode 114 are electrically connected to the first connector 13 through a wire. A first magnetic positioning sensor 115 is provided in the arc segment 1110. The first magnetic positioning sensor 115 is electrically connected to the first connector 13 through a wire. The distal end of the Luer connector 14 is connected to the proximal end of the main conduit body 2. When the pull wire 111 is pulled, the arc segment 1110 is completely bent and deformed, and curled toward the proximal end of the arc segment 1110 to form a near ring shape.

[0037] like Figure 4 , Figure 5 and Figure 7 As shown, after the arc segment 1110 is completely curled and deformed, the proximal end and the distal end of the arc segment 1110 are not in the same spatial plane.

[0038] like Figure 1 As shown, except for the arc-shaped section 1110 at the distal end, the rest of the main catheter body 11 is the main catheter body 1111 , and the catheter lumen 112 is formed by the lumen of the main catheter body 1111 .

[0039] In the present invention, the arc segment 1110 and the main conduit body 1111 can be made of the same or different materials.

[0040] In the present invention, the main conduit body 1111 is made of PEBAX, polyurethane, block polyamide or nylon, with an outer diameter of 0.8 mm to 5.4 mm, preferably 1.6 to 2.7 mm, an inner diameter of 0.5 mm to 4 mm, preferably 1 to 2 mm, and a length of 400 mm to 2100 mm, preferably 800 to 1050 mm; a mesh layer 1112 is embedded in the wall of the main conduit body 1111, and the mesh layer 1112 is a stainless steel wire mesh.

[0041] like Figure 8 As shown, in the present invention, the arc segment 1110 is provided with three lumens, namely, the wire lumen 116, the wire lumen 117, and the through-hole lumen 118, wherein the through-hole lumen 118 is located at the center of the arc segment 1110 and is arranged on the same axis as the catheter through-lumen 112. The three lumens are all connected to the catheter through-lumen 112, and the distal end of the wire pull wire 111 is connected to the distal end of the arc segment 1110 through the wire lumen 117, specifically the distal end position, and the wires of the first end electrode 113, the first ring electrode 114, and the first magnetic positioning sensor 115 pass through the wire lumen 116 and then pass through the catheter through-lumen 112 and are electrically connected to the first connector 13.

[0042] like Figure 8 As shown, the first magnetic positioning sensor 115 is disposed in the guide wire lumen 116 .

[0043] The outer diameter of the arc segment 1110 is 2 mm to 3.7 mm, preferably 2 mm to 3 mm, and the length is 20 mm to 200 mm, preferably 50 mm to 100 mm. The diameter of the through hole lumen 118 is 0.3 mm to 1.5 mm, preferably 0.75 mm to 0.85 mm, and the diameters of the guide wire lumen 116 and the pull wire lumen 117 are 0.2 mm to 1.4 mm, preferably 0.6 mm to 0.7 mm. The arc segment 1110 is made of segmented polyetheramide resin (PEBAX), polyurethane, segmented polyamide or nylon, and has elasticity, so that the bending degree of the arc segment 1110 can be adjusted by the adjustable bending handle device 13.

[0044] At least three annular first ring electrodes 114 are provided on the surface of the arc segment 1110. The inner diameter of the first ring electrode 114 is 0.33 mm to 4 mm, preferably 1 mm to 3 mm, the outer diameter is 0.38 mm to 4.05 mm, preferably 1.05 mm to 3.05 mm, and the width is 0.2 mm to 4 mm, preferably 1 mm to 3 mm. The first ring electrode 114 is embedded on the surface of the arc segment 1110. The wire connected to the inner side of the first ring electrode 114 is electrically connected to the first connector 13 through the wire lumen 116, the catheter lumen of the main catheter body 1111 (or the body wall of the main catheter body 1111), and the adjustable curved handle device 12. The first ring electrode 114 is made of platinum-iridium alloy or gold.

[0045] The first connector 13 can be placed at the rear end of the handle through an extension line, or can be placed inside the handle.

[0046] The conductive wire of the first ring electrode 114 is made of copper wire with a diameter of 0.01 mm to 0.5 mm, preferably 0.1 mm to 0.2 mm. The outer side of the copper wire is covered with an insulating coating, and its insulation strength is above 500V, preferably above 2000V.

[0047] like Figure 8 As shown, the first end electrode 113 connected to the distal end of the arc segment 1110 is annular, has an opening, is annular, and is embedded in the distal end of the catheter by a thermal fusion process. The wire drawing wire 9 is welded to the proximal end of the first end electrode 113, and a rivet tube 1114 is provided near the welding point. Figure 3 As shown, the opening portion of the first terminal electrode 113 has a diameter of 0.5 mm to 2 mm, preferably 1 mm to 1.5 mm, a length of 0.3 mm to 5 mm, preferably 1 mm to 4 mm, and is made of platinum-iridium alloy or gold.

[0048] like Figure 8 As shown, a hose 119 is provided in the catheter lumen 112, the distal end of the hose 119 passes through the through-hole lumen 118 and is inserted into the opening of the first end electrode 113, and the proximal end passes through the adjustable curved handle device 12 and is connected to the Luer connector 14. The hose 119 can inject contrast agent into the blood vessel from the opening of the first end electrode 113 through the Luer connector 14, and can also input the mapping auxiliary catheter through the Luer connector 14 and output it into the blood vessel through the opening of the first end electrode 113. The hose 119 is made of segmented polyetheramide resin (PEBAX), polyurethane, segmented polyamide or nylon, and has a diameter of 0.5 mm to 2 mm, preferably 1 mm to 1.5 mm.

[0049] like Figure 8 As shown, the surface of the wire drawing wire 111 is coated with a wire drawing outer tube 1113, which is used to prevent the wire drawing wire 111 from rubbing against the inner wall of the wire drawing tube cavity 117 during the pulling process, thereby affecting the bending shape of the main guide tube for marking. The distal end of the wire drawing wire 111 is connected to the first end electrode 113 by welding. A rivet tube 1114 is provided near the welding point between the wire drawing wire 111 and the first end electrode 113, and the rivet tube 1114 is welded to the wire drawing wire 111. The surface of the rivet tube 1114 is coated with a rivet tube sleeve 1115, and the rivet tube 1114 is provided at the distal end face of the wire drawing tube cavity 117.

[0050] like Fig.10 As shown, the adjustable bending handle device 12 adopts a rotating handle, generally including a handle shell 122 with a rotating body shape and a handle cover 123. The handle shell 122 is provided with a through hole 124 coaxial therewith, a push rod 125, a handle cover hole 126, a limit bolt 127, a locking nut 128, and a steel wire fixing column 121.

[0051] The outer edge of the distal end of the handle housing 122 is threadedly connected to the handle cover 123, and the handle cover 123 is provided with a handle cover hole 126 coaxial with the through hole 124. The cylindrical push rod 125 is placed in the through hole 124 through the handle cover hole 126, and its movement range is controlled by the limit bolt 127. The main guide body 11 is fixed to the push rod 125 via a locking nut 128, wherein the wire drawing wire 111 passes through the wire drawing tube cavity 117 and the main guide tube body 1111, and is connected to the wire fixing column 121 via the adjustable curved handle 13.

[0052] The push rod 125 is pushed axially and extends out of the handle housing 122 . The length of the pull wire 111 remains unchanged, so that the arc segment 1110 bends, thereby achieving the purpose of adjusting the bending degree of the arc segment 1110 .

[0053] like Fig.11 and Fig.12 As shown, the secondary mapping catheter 2 includes a secondary catheter body 21, a branching connector 22, and a second connector 23 from the distal end to the proximal end, wherein:

[0054] The outer diameter of the auxiliary catheter body 21 is less than or equal to the diameter of the catheter lumen 112. A mapping section 24 is provided at the distal end of the auxiliary catheter body 21. A second end electrode 211 is provided at the distal end of the mapping section 24. A second magnetic positioning sensor 212 is provided in the mapping section 24. The second end electrode 211 and the second magnetic positioning sensor 212 are electrically connected to the second connector 23 through wires via a branching connector 22.

[0055] like Fig.11 and Fig.12 As shown, a second ring electrode 213 is provided on the mapping section 24, and the second ring electrode 213 is electrically connected to the second connector 23 through a wire through a branching connector 22, so as to obtain physiological information of each point at the target position.

[0056] The number of the second ring electrodes 213 is 1 to 20, preferably 2 to 10, and the inner diameter of the second ring electrode 213 is 0.1 mm to 2 mm, preferably 0.3 mm to 1 mm. The second ring electrode 213 is connected to the second connector 23 through the lumen of the secondary catheter body 21 by a wire 25, and the wire 25 is a copper wire with a diameter of 0.01 mm to 0.5 mm, preferably 0.1 mm to 0.2 mm. An insulating coating is attached to the outside of the copper wire, and its insulation strength is above 500 V, preferably above 2000 V. The secondary catheter body 21 is made of segmented polyetheramide resin (PEBAX), polyurethane, block polyamide or nylon.

[0057] The method of using the present invention is as follows: the distal end of the first end electrode of the mapping main catheter with a magnetic positioning function is pushed from the femoral vein into the heart, and the arc segment 1110 is controlled to bend through the adjustable bending handle device 13, so that the first end electrode 113 and the arc segment 1110 can smoothly enter the coronary sinus opening, and the first ring electrode 114 is in contact with the inner wall of the coronary sinus and moves continuously to obtain the electrophysiological information of each point of the heart, and the mapping secondary catheter 2 is extended into the coronary vein through the first end electrode 113 with an opening through the standard Luer connector 14 to map the thinner coronary vein blood vessels, and the electrophysiological information of each point at the target position is obtained through the second ring electrode 213, and the real-time position of the catheter in the coronary vein is obtained through the magnetic positioning sensor in each catheter, and the modeling is guided.

[0058] The present invention provides a first end electrode with an opening and a first ring electrode for mapping at the distal end of the main catheter body. The distal end of the main catheter body can be bent into an approximately L-shaped arc segment (the arc segment is the shape in the natural state), and an approximately ring structure formed after the arc segment is curled. The plane formed forms an angle with the main catheter body, and the ring structure is a spatial bend, which is a bend specially designed for the coronary sinus and is easier to enter the coronary sinus ostium. The front end opening design of the first end electrode can also deliver the mapping auxiliary catheter used for distal coronary vein mapping to the distal coronary vein that is difficult to reach with traditional catheters. The second end electrode and the second ring electrode are closely attached to the inner wall of the coronary sinus, and the electrophysiological signal collection is stable. At the same time, the magnetic positioning sensor can determine the real-time position of the catheter in the blood vessel, and the coronary vein is modeled to reduce the X-ray exposure time. It is convenient for surgical operations, reduces the number of catheters used, reduces the burden on patients, makes the operation safer and faster, and greatly increases the effectiveness and operability of the operation in clinical practice, saving operation time.

Claims

1. A three-dimensional distal coronary vein mapping catheter, comprising a main mapping catheter (1), characterized in that: Also included is a mapping auxiliary catheter (2); The main mapping catheter (1) comprises, from the distal end to the proximal end, a main catheter body (11), an adjustable curved handle device (12), a first connector (13), and a Luer connector (14); The distal end of the main catheter body (11) is bent in a normal state to form an arc segment (1110). The proximal end of the main catheter body (11) is connected to an adjustable bending handle device (12), so that the arc segment (1110) is completely bent and deformed under the drive of the adjustable bending handle device (12). The main catheter body (11) has a catheter through cavity (112), which runs through the main catheter body (11). A first end electrode is provided at the distal end of the arc segment (1110). (113), first ring electrodes (114) are arranged at intervals on the arc segment (1110), the first end electrode (113) and the first ring electrode (114) are electrically connected to the first connector (13) through a wire, a first magnetic positioning sensor (115) is arranged in the arc segment (1110), the first magnetic positioning sensor (115) is electrically connected to the first connector (13) through a wire, and the distal end of the Luer connector (14) is connected to the proximal end of the main conduit body (2); The mapping auxiliary catheter (2) comprises, from the distal end to the proximal end, an auxiliary catheter body (21), a branching connector (22), and a second connector (23); The outer diameter of the auxiliary catheter body (21) is less than or equal to the diameter of the catheter cavity (112), and a mapping section is provided at the distal end of the auxiliary catheter body (21), a second end electrode (211) is provided at the distal end of the mapping section, and a second magnetic positioning sensor (212) is provided in the mapping section, and the second end electrode (211) and the second magnetic positioning sensor (212) are respectively electrically connected to the second connector (23) through a branching connector (22) via a wire.

2. The three-dimensional distal coronary vein mapping catheter according to claim 1, characterized in that: After the arc segment (1110) is completely curled and deformed, the proximal end and the distal end of the arc segment (1110) are not on the same spatial plane.

3. The three-dimensional distal coronary vein mapping catheter according to claim 1 or 2, characterized in that: The arc segment (1110) is provided with three lumens, namely a wire lumen (116), a pull wire lumen (117), and a through hole lumen (118); the three lumens are all connected to the catheter lumen (112); the wires of the first end electrode (113), the first ring electrode (114), and the first magnetic positioning sensor (115) pass through the wire lumen (116) and then through the catheter lumen (112) to be electrically connected to the first connector (13).

4. The three-dimensional distal coronary vein mapping catheter according to claim 3, characterized in that: The first end electrode (113) is annular in shape, and a central opening thereof is connected to the catheter lumen (112).

5. The three-dimensional distal coronary vein mapping catheter according to claim 4, characterized in that: The through hole lumen (118) is located at the center of the arc segment (1110) and is arranged on the same axis as the catheter lumen (112).

6. The three-dimensional distal coronary vein mapping catheter according to claim 5, characterized in that: There are at least three first ring electrodes (114).

7. The three-dimensional distal coronary vein mapping catheter according to claim 6, characterized in that: A hose (119) is provided in the catheter lumen (112); the distal end of the hose (119) passes through the through-hole lumen (118) and is inserted into the opening of the first end electrode (113); the proximal end passes through the adjustable curved handle device (12) and is connected to the Luer connector (14).

8. The three-dimensional distal coronary vein mapping catheter according to claim 1, characterized in that: The main conduit body (11) is provided with a grid layer (1112) in the rest of the conduit body except the arc-shaped section (1110).

9. The three-dimensional distal coronary vein mapping catheter according to claim 1, characterized in that: A second ring electrode (213) is provided on the mapping section, and the second ring electrode (213) is electrically connected to the second connector (23) via a wire through a branching connector (22).

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