High-precision multi-polar calibration electrode guide tube with rake-shaped tip

Abstract

The present invention discloses a rake-shaped head-end high-precision multipolar mapping electrode catheter, and the technical problem to be solved is to improve the accuracy of the mapping signal, reduce the difficulty of the operation, and improve the efficiency of the operation. The present invention is provided with a catheter, and the distal end of the catheter is provided with 2 to 8 branch tubes with the distal end portions being arranged in parallel in a straight line and the proximal end portions being in an arc shape. The proximal ends of the branch tubes are gradually gathered and connected to the distal ends of the end tubes. At least two ring electrodes are provided on the outer surface of the branch tubes, and the number of ring electrodes of each branch tube is the same. An escort tube is sleeved on the outer surface of the catheter, which forms an intermittent match with the catheter. Compared with the prior art, the present invention can quickly and safely perform high-density mapping in the entire heart cavity of the heart. The escort tube facilitates pushing the branch tube to the distal end, and the sensor can realize the positioning of the catheter. The three-dimensional cardiac electrophysiological mapping of the computer can directly and quickly perform three-dimensional imaging of the patient's heart cavity, and complete three-dimensional modeling, which greatly increases the effectiveness and operability of the operation and saves operation time.

Description

Technical Field

[0001] The invention relates to a medical surgical instrument, in particular to an electrode catheter used for cardiac electrophysiological mapping. Background Art

[0002] Since its inception, intracardiac electrophysiological mapping has been the gold standard for the diagnosis of arrhythmia. Since the promotion of radiofrequency ablation and other treatment methods, it has become a major treatment method alongside drug therapy, and has developed by leaps and bounds in the past 10 years. Common diseases that can be treated with radiofrequency ablation include atrial fibrillation, paroxysmal supraventricular tachycardia, ventricular premature beats, ventricular tachycardia, and most rapid arrhythmias. In common and complex radiofrequency ablation processes such as atrial fibrillation and ventricular tachycardia, as research and practice deepen, how to accurately map the location of abnormal electrical activity becomes increasingly important, and various methods and equipment for high-precision mapping have also been rapidly developed and matured.

[0003] The existing cardiac electrophysiology method is to obtain structural information in the human body through X-ray imaging or contrast imaging. This method increases the patient's exposure time to X-rays and the dosage of contrast agent used, which can easily cause harm to the patient. The resulting image is a two-dimensional image, which is difficult for doctors to identify and inconvenient to operate, increasing the difficulty of the operation. Summary of the invention

[0004] The purpose of the present invention is to provide a high-precision multi-polar mapping electrode catheter with a rake-shaped tip, and the technical problem to be solved is to improve the accuracy of the mapping signal, reduce the difficulty of the operation, and improve the efficiency of the operation.

[0005] The present invention adopts the following technical scheme: a rake-shaped head-end high-precision multipolar mapping electrode catheter, which is provided with a catheter, wherein the distal end of the catheter is provided with 2 to 8 branch tubes, the distal ends of which are linearly arranged in parallel and the proximal ends are arc-shaped, the proximal ends of the branch tubes are gradually gathered and connected to the distal ends of the end tubes, at least two ring electrodes are provided on the outer surface of the branch tubes, and the number of ring electrodes of each branch tube is the same, and the outer surface of the catheter is sleeved with a conveyor tube, which forms an intermittent fit with the catheter.

[0006] The branch pipe of the present invention is provided with a shaping wire with a memory function.

[0007] The invention has four branch pipes, and four ring electrodes are arranged on the surface of the branch pipes. The ring electrodes on the surface of the four branch pipes are orthogonally arranged with equal spacing of 4×4.

[0008] The first branch pipe and the fourth branch pipe of the present invention have the same shape and are symmetrically distributed, and the second branch pipe and the third branch pipe have the same shape and are symmetrically distributed.

[0009] The proximal outer surface of the first branch pipe of the present invention is provided with an identification ring.

[0010] The outer surface of the end tube of the present invention is provided with at least one tube body electrode.

[0011] The distal end of the end tube of the present invention is provided with a shaping die, which is cylindrical in shape and has four shaping wire through holes and a salt water pipe through hole opened along its axis. The shaping wire through holes are evenly distributed in a straight line on the same diameter.

[0012] The brine pipe through hole of the present invention is fixedly provided with a brine pipe, and the distal end surface of the brine pipe reaches the distal end surface of the shaping mold.

[0013] A sensor A for sensing position is arranged at a position near the proximal end of the shaping die (34) in the inner cavity of the end tube of the present invention.

[0014] The sensor A of the present invention adopts an electromagnetic sensor.

[0015] Compared with the prior art, the present invention has a branch tube at the distal end of the catheter, the distal part of which is linear and parallel, and the proximal part of which is arc-shaped. The proximal end of the branch tube is gradually gathered and connected to the distal end of the end tube. At least two ring electrodes are provided on the outer surface of the branch tube, and the number of ring electrodes of each branch tube is the same, so that high-density mapping of the entire heart cavity can be performed quickly and safely. A conveyor tube is sleeved on the outer surface of the catheter to facilitate pushing the branch tube to the distal end. A sensor is provided at the distal end of the catheter to achieve positioning of the catheter. The computer three-dimensional cardiac electrophysiological mapping technology can directly and quickly perform three-dimensional imaging of the patient's heart cavity and complete three-dimensional modeling, which greatly increases the effectiveness and operability of the operation in clinical practice and saves operation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a structural schematic diagram of the present invention.

[0017] Figure 2 It is a schematic diagram of the head end structure of the present invention.

[0018] Figure 3 It is a schematic cross-sectional view of a branch pipe of the present invention.

[0019] Figure 4 It is a schematic cross-sectional view of the shaping die of the present invention.

[0020] Figure 5 It is an axial cross-sectional view of the end tube of the present invention.

[0021] Figure 6 It is a schematic cross-sectional view of a three-hole pipe of the present invention.

[0022] Figure 7 It is an axial cross-sectional view of the catheter body of the present invention.

[0023] Figure 8 It is a structural schematic diagram of the handle device of the present invention.

[0024] Fig. 9 It is a schematic diagram of a bipolar electrogram formed by two adjacent ring electrodes of the present invention. DETAILED DESCRIPTION

[0025] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments.

[0026] like Figure 1 As shown, the rake-shaped tip high-precision multipolar mapping electrode catheter of the present invention is provided with a catheter 2 and a handle device 1 connected in sequence from the distal end to the proximal end, and the proximal end of the handle device 1 is connected to a connector 7 and a saline pipe connector 9.

[0027] The catheter 2 is provided with a head end 3, a three-hole tube 4 and a catheter body 5 which are sequentially connected from the distal end to the proximal end. A escort tube 6 is disposed on the catheter 2, and in a non-working state, the escort tube 6 is disposed outside the catheter body 5.

[0028] like Figure 2 As shown, in this embodiment, the head end 3 is composed of a branch tube 31 at the distal end and an end tube 35 at the proximal end, and the distal end is in a four-arm rake shape. The branch tubes 31 are 4 distal parts arranged in parallel in a straight line, and the proximal part is in an arc shape. The proximal end is gradually gathered and connected to the distal end of the end tube 35 to form a rake shape. A molding mold 34 is provided in the distal end of the end tube 35. As shown in the figure, the branch tubes 31 are arranged in sequence from top to bottom, and are respectively set as the first to fourth branch tubes for distinction. Among them, the first branch tube and the fourth branch tube have the same shape and are symmetrically distributed, and the second branch tube and the third branch tube have the same shape and are symmetrically distributed. An annular identification ring 36 is provided on the proximal outer surface of the first branch tube 31 to indicate the first branch tube. According to the needs of clinical use, there can be 2 to 8 branch tubes 31.

[0029] like Figure 3 As shown, the branch tube 31 is tubular, and a shaping wire 32 is arranged in the lumen. The shaping wire 32 is made of nickel-titanium alloy wire, and is shaped into a straight shape at the distal end and an arc shape at the proximal end by a thermoforming method of the prior art. The shaping wire 32 has a good memory function and can shape the shape of the branch tube 31 well. The distal end of the branch tube 31 is a smooth hemispherical shape, which forms a sealing structure with the branch tube 31. The inner diameter of the branch tube 31 is 0.4-1.0mm, the outer diameter is 0.6-1.2mm, and the length is 15-25mm. The diameter of the shaping wire 32 is 0.07-0.15mm, and the length is consistent with that of the branch tube 31. Its distal end and the branch tube are fixed in the hemispherical shape by glue, and the proximal end is placed in the through hole 341 of the shaping mold 34.

[0030] like Figure 4As shown, the shaping mold 34 is cylindrical in shape, and has four shaping wire through holes 341, one wire through hole 342, and one salt water pipe through hole 343 along its axis. The axes of the six through holes are parallel to the shaping mold axis, and the four shaping wire through holes 341 are evenly distributed in a straight line on the same diameter, and are used to fix the proximal ends of the four branch pipes 31, so that the four branch pipes 31 are distributed in a plane. The wire through hole 342 and the salt water pipe through hole 343 are symmetrically arranged on both sides of the center line of the shaping wire through hole 341.

[0031] At least two annular ring electrodes 33 are disposed on the outer surface of the branch pipe 31, and the number of ring electrodes 33 of each branch pipe 31 is the same. In this embodiment, four ring electrodes 33 are disposed on the surface of the branch pipe 31, and the 16 ring electrodes 33 on the surface of the first to fourth branch pipes 31 are orthogonally arranged at equal intervals of 4×4, such as Fig. 9 As shown, along the axial and radial directions of the branch tube, each adjacent two ring electrodes form a pair of bipolar electrograms, for a total of 24 pairs. Therefore, the electrocardiogram of the same point in the heart can synchronously record the intracardiac electrical signals from two orthogonal directions. The inner diameter of the ring electrode 33 is 0.8-1.2 mm, the outer diameter is 0.9-1.3 mm, and the width is 0.5-1 mm.

[0032] The inner side of the ring electrode 33 is connected to the distal end of the wire 331. The wire 331 passes through the lumen of the branch tube 31, the wire through hole 342 of the shaping mold, the inner lumen of the end tube 35, the third lumen 43 of the three-hole tube 4, the inner lumen of the catheter body 5, and the handle device 1, and the proximal end of the wire 331 is connected to the connector 7.

[0033] The ring electrode 33 and the marking ring 36 are made of platinum-iridium alloy or gold. The lead wire 331 is made of copper wire with a diameter of 0.1-0.2 mm.

[0034] A saline tube 91 is disposed in the saline tube through hole 343, and the saline tube 91 is fixed in the saline tube through hole 343 by glue, and the distal end surface of the saline tube 91 is flush with the distal end surface of the shaping mold 34. The saline tube 91 passes through the inner cavity of the end tube 35, the second tube cavity 42 of the three-hole tube 4, the inner cavity of the catheter tube body 5, and the handle device 1, and the proximal end of the saline tube 91 is connected to the saline tube connector 9.

[0035] like Figure 5 As shown, the end tube 35 is tubular, and the shaping mold 34 is fixed to the distal end of the inner cavity of the end tube 35 by glue, flush with the distal end surface of the end tube 35. The end tube 35 is made of block polyether amide resin PEBAX, polyurethane, block polyamide or nylon. The outer diameter of the end tube 35 is 2 to 2.7 mm, the inner diameter is 1 to 2 mm, and the length is 5 to 15 mm.

[0036] A position sensing sensor A is provided in the inner cavity of the end tube 35 near the proximal end of the sizing mold 34. The wire connecting the sensor A passes through the inner cavity of the end tube 35, the second cavity 42 of the three-hole tube 4, the inner cavity of the catheter body 5, and the handle device 1 to the connector 7. The diameter of the sensor A is 0.8-1 mm and the length is 5-10 mm. This embodiment uses an electromagnetic sensor.

[0037] At least one annular tube body electrode 37 is provided on the outer surface of the end tube 35 for mapping and positioning. The inner diameter of the tube body electrode 37 is 1.8-2.7 mm, the outer diameter is 2.0-3.0 mm, and the width is 0.5-4 mm. The tube body electrode wire 331 connected to the inner side of the tube body electrode 37 passes through the inner cavity of the end tube 35, the third lumen 43 of the three-hole tube 4, the inner cavity of the catheter tube body 5, and the handle device 1 to connect to the connector 7. The tube body electrode 37 is made of platinum-iridium alloy or gold. The tube body electrode wire 331 is made of copper wire with a diameter of 0.1-0.2 mm.

[0038] like Figure 6 As shown, the three-hole tube 4 is tubular, and is provided with three through holes along the axial direction, namely, the first tube cavity 41, the second tube cavity 42 and the third tube cavity 43, and the axes of the through holes are respectively parallel to the axis of the three-hole tube 4. The second tube cavity 42 and the third tube cavity 43 are evenly distributed on the diameter connection line of the three-hole tube 4, and the first tube cavity 41 is located on one side of the connection line of the second tube cavity 42 and the third tube cavity 43. The first tube cavity 41, the second tube cavity 42 and the third tube cavity 43 are connected with the inner cavity of the end tube 35 and the catheter body 5.

[0039] The three-hole tube 4 has an outer diameter of 2 to 2.7 mm and a length of 50 to 100 mm. The inner diameter of the first lumen 41 is 0.2 to 0.8 mm, and the inner diameters of the second lumen 42 and the third lumen 43 are consistent, which are 0.5 to 1.2 mm.

[0040] The three-hole tube 4 is made of segmented polyetheramide resin PEBAX, polyurethane, segmented polyamide or nylon, and has elasticity, so that the bending degree of the three-hole tube 4 can be adjusted by the handle device 1.

[0041] A wire drawing wire B passes through the first lumen 41 of the three-hole tube 4, and the surface of the wire drawing wire B is covered with a wire drawing outer tube B1, which is used to prevent the wire drawing wire B from rubbing against the inner wall of the first lumen 41 during the pulling process, thereby affecting the bending shape of the catheter 2. The distal end of the wire drawing wire B is connected to the end tube 35, and the distal end of the wire drawing wire B is welded and connected to a rivet tube B2, and the surface of the rivet tube B2 is covered with a rivet tube sleeve B3, and the rivet tube B2 is arranged at the proximal end of the inner lumen of the end tube 35 and the thermal fusion joint of the three-hole tube. The wire drawing wire B passes through the first lumen 41 of the three-hole tube 4, the inner lumen of the catheter body 5, and the handle device 1, and the proximal end is connected to the connector 7. The rivet tube B2 is made of 304 stainless steel.

[0042] The wire of the sensor A and the saline tube 91 are passed through the second lumen 42 of the three-hole tube 4 .

[0043] A guide wire 331 and a tube body electrode guide wire 331 pass through the third tube cavity 43 of the three-hole tube 4 .

[0044] like Figure 7 As shown, the catheter body 5 is tubular. The distal end of the catheter body 5 is connected to the three-hole tube 4, and the proximal end is connected to the distal end of the handle device 1.

[0045] The catheter body 5 is made of PEBAX, polyurethane, block polyamide or nylon, with an outer diameter of 2-2.7 mm, an inner diameter of 1-2 mm, and a length of 900-1150 mm. A stainless steel wire mesh 51 is embedded in the wall of the catheter body 5 .

[0046] A escort tube 6 is sleeved on the outer surface of the catheter body 5. The escort tube 6 is tubular and forms an intermittent fit with the end tube 35, the three-hole tube 4 and the catheter body 5. When the escort tube 6 is pushed toward the distal end along the catheter body 5, the four branch tubes 31 can be gathered therein, making it convenient for the surgeon to smoothly push the distal end of the catheter 2 into the human blood vessel mapping site.

[0047] like Figure 8 As shown, the handle device 1 is provided with a handle housing 12 with a shape of a rotating body, and the rotating body is provided with a through hole 11 coaxial therewith.

[0048] A handle cover 13 is threadedly connected to the outer edge of the distal end of the handle housing 12 . The handle cover 13 has a concave axial section, an end surface facing the distal end and a handle cover hole 14 coaxial with the through hole 11 .

[0049] The handle device 1 is provided with a cylindrical push rod 15, and the push rod 15 is provided with a push rod through hole 154 coaxial therewith. The outer edge of the push rod 15 is provided with a push handle 151 protruding outwardly, and the push handle 151 divides the push rod 15 into a distal rod portion 152 and a proximal rod portion 153. The proximal rod portion 153 extends into the distal end of the through hole 11 through the handle cover hole 14, and the internal thread of the handle cover 13 is screwed into the distal outer edge of the handle housing 12, and the proximal rod portion 153 is arranged in the distal end of the through hole 11 of the handle housing 12.

[0050] A guide groove 155 parallel to the axis of the handle housing 12 is opened on the outer peripheral wall of the proximal rod portion 153, and a limiting screw hole 111 connected to the through hole 11 is opened on the peripheral wall of the distal end of the handle housing 12 at a position corresponding to the position of the guide groove 155. The lower end of the limiting bolt 16 threadedly connected to the limiting screw hole 111 extends into the guide groove 155 to limit the axial movement position of the push rod 15.

[0051] A locking nut 17 is threadedly connected to the distal end of the distal rod portion 152 to fix the proximal end of the catheter body 5 in the lumen at the distal end of the push rod through hole 154 .

[0052] A handle inner core 18 having a columnar shape is provided in the proximal end of the through hole 11. The handle inner core 18 has an inner core through hole 181 formed along the axis of the through hole 11. A first screw hole 182 is provided on the outer peripheral wall of the handle inner core 18 and is perpendicular to and communicates with the inner core through hole 181. A second screw hole 112 is provided on the proximal peripheral wall of the handle housing 12. The first screw hole 182 and the second screw hole 112 are threadedly connected with a steel wire fixing column 19. A steel wire positioning column through hole 191 is provided at the lower end of the steel wire fixing column 19 and is communicated with the inner core through hole 181. The axis of the steel wire positioning column through hole 191 is perpendicular to the axis of the steel wire fixing column 19.

[0053] After the pulling wire B passes through the first tube cavity 41 of the three-hole tube 4 and the catheter body 5, its proximal end passes through the push rod through hole 154, the distal part of the inner core through hole 181, the wire positioning column through hole 191, and the proximal part of the inner core through hole 182, and then the wire fixing column 19 is rotated to make the wire positioning column through hole 191 and the inner core through hole 181 misaligned, thereby fixing the proximal end of the pulling wire B.

[0054] The push handle 151 of the push rod 15 is pushed axially to the far end, and the push rod 15 extends out of the far end of the handle housing 12. The length of the wire B remains unchanged, so that the three-hole tube 4 is bent. The pushing distance of the push rod 15 can adjust the bending degree of the three-hole tube 4. The specific process is as follows:

[0055] The wire drawing wire B passes through the first lumen 41 of the three-hole tube 4. Since the first lumen 41 is an eccentric hole deviating from the axis of the catheter 2, during the assembly of the catheter 2, the proximal end face of the three-hole tube 4 and the distal end face of the catheter 5 are connected and fixed by a heat fusion process, and the rivet tube B2 at the distal end of the wire drawing wire B is fixedly connected with the glue in the inner cavity of the end tube 35. After the proximal end is connected and fixed with the handle inner core 18, the length of the wire drawing wire B is fixed. When the push rod 15 is pushed axially, since the three-hole tube 4 is elastic, the thrust of the push rod 15 will bend the three-hole tube 4 toward the proximal end through the wire drawing wire B. By controlling the length of the wire drawing wire B, the bending angle of the three-hole tube 4 can be adjusted.

[0056] The method of using the present invention is as follows: the escort tube 6 is pushed toward the distal end along the catheter 2, and the four branch tubes 31 are gathered therein, and the distal end of the rake-shaped head end high-precision multipolar mapping electrode catheter is pushed from the femoral artery into the heart cavity, and the handle device 1 is operated to control the bending of the three-hole tube 4, so that the head end 3 and the three-hole tube 4 can smoothly enter the heart, and the escort tube 6 is retracted toward the proximal end along the catheter 2, and the branch tube 31 is released, so that the ring electrode 33 on the branch tube 31 is in contact with the inner wall of the heart, and the electrophysiological information of each point is obtained, and the electrophysiological information is fed back to the three-dimensional mapping system. The sensor A placed in the inner cavity of the end tube 35 can perform three-dimensional modeling of the catheter, and the electrophysiological mapping navigation system can accurately locate and obtain the coordinate data of the distal end of the catheter by using the sensor A and the magnetic field generator under the operating table, so as to realize the positioning of the distal end of the catheter.

[0057] In the present invention, the annular ring electrode 33 on the outer surface of the branch tube 31 with a rake-like structure at the distal end is attached to the heart tissue, and the intracardiac electrical signal is transmitted to the electrophysiological mapping navigation system through the ring electrode 33, the wire 331, and the connector 7. In order to avoid thrombus formation during the mapping process, an anticoagulant can be injected, and the anticoagulant flows through the proximal saline tube connector 9 through the saline tube 91 to reach the mapping site in the heart.

[0058] The present invention can quickly and safely perform high-density mapping of the entire cardiac cavity. The rake-like structure enables the ring electrodes 33 to be arranged orthogonally at 4×4 equal intervals, forming 24 pairs of bipolar electrograms. The electrocardiogram at the same point in the heart can synchronously record intracardiac electrical signals from two directions. This avoids the information omission caused by the different directions of intracardiac current conduction in the prior art mapping. By using the high-precision multi-polar mapping electrode catheter with a rake-like head end of the present invention for mapping, doctors can fully understand the matrix of local myocardial lesions, which may change the previous understanding and definition of the disease, and then formulate the best ablation plan.

[0059] The present invention sets sensor A in the inner cavity of the end tube 35, which can realize the positioning and navigation of the distal end of the catheter, and cooperate with the three-dimensional mapping system to quickly realize the mapping and modeling of the three-dimensional anatomical structure of the heart, which greatly increases the effectiveness and operability of the operation in clinical practice and saves operation time. When sensor A is not used, it can be used in conjunction with a multi-channel electrophysiological instrument to perform two-dimensional mapping of the heart chamber, so that the present invention has multiple uses.

Claims

1. A high-precision multipolar mapping electrode catheter with a rake-shaped tip, provided with a catheter (2), wherein the distal end of the catheter (2) is provided with 2 to 8 branch tubes (31) with the distal ends being straight and parallel and the proximal ends being arc-shaped, the proximal ends of the branch tubes (31) being gradually gathered and connected to the distal ends of the end tubes (35), the outer surface of the catheter (2) is sheathed with a conveying tube (6) which forms an intermittent fit with the catheter (2), characterized in that: The branch pipes (31) are distributed in a plane, and at least two ring electrodes (33) are provided on the outer surface of the branch pipes (31), and the number of the ring electrodes (33) of each branch pipe (31) is the same.

2. The high-precision multi-polar mapping electrode catheter with a rake tip according to claim 1, characterized in that: The branch pipe (31) is provided with a shaping wire (32) having a memory function.

3. The high-precision multi-polar mapping electrode catheter with a rake tip according to claim 2, characterized in that: There are four branch pipes (31), and four ring electrodes (33) are arranged on the surface of the branch pipes (31). The ring electrodes (33) on the surface of the four branch pipes (31) are orthogonally arranged at equal intervals of 4×4.

4. The rake-shaped tip high-precision multi-polar mapping electrode catheter according to claim 3, characterized in that: The first branch pipe (31) and the fourth branch pipe (31) have the same shape and are symmetrically distributed, and the second branch pipe (31) and the third branch pipe (31) have the same shape and are symmetrically distributed.

5. The high-precision multi-polar mapping electrode catheter with a rake tip according to claim 4, characterized in that: The proximal outer surface of the first branch pipe (31) is provided with an identification ring (36).

6. The high-precision multi-polar mapping electrode catheter with a rake tip according to claim 5, characterized in that: At least one tube body electrode (37) is provided on the outer surface of the end tube (35).

7. The high-precision multi-polar mapping electrode catheter with a rake tip according to claim 6, characterized in that: A shaping die (34) is arranged at the distal end of the end tube (35). The shaping die (34) is cylindrical in shape and has four shaping wire through holes (341) and a salt water pipe through hole (343) along its axis. The shaping wire through holes (341) are evenly distributed in a straight line on the same diameter.

8. The high-precision multi-polar mapping electrode catheter with a rake tip according to claim 7, characterized in that: A saline tube (91) is fixedly disposed in the saline tube through hole (343), and the distal end surface of the saline tube (91) is aligned with the distal end surface of the shaping mold (34).

9. The high-precision multipolar mapping electrode catheter with a rake tip according to claim 8, characterized in that: A sensor A for sensing position is arranged at a position of the inner cavity of the end tube (35) near the proximal end of the shaping die (34).

10. The high-precision multi-polar mapping electrode catheter with a rake tip according to claim 9, characterized in that: The sensor A is an electromagnetic sensor.

Images