CN111436928A

CN111436928A - Rake-shaped head end high-precision multi-polar mapping electrode catheter

Info

Publication number: CN111436928A
Application number: CN202010365494.9A
Authority: CN
Inventors: 杨洋; 成正辉; 韩永贵
Original assignee: Shenzhen Huitai Medical Equipment Co ltd
Current assignee: Shenzhen Huitai Medical Equipment Co ltd
Priority date: 2020-04-30
Filing date: 2020-04-30
Publication date: 2020-07-24

Abstract

The invention discloses a rake-shaped head end high-precision multi-electrode mapping electrode catheter, and aims to solve the technical problems of improving the precision of mapping signals, reducing the operation difficulty and improving the operation efficiency. The invention is provided with a catheter, wherein the distal end of the catheter is provided with 2-8 branched pipes, the distal end parts of the branched pipes are arranged in parallel in a linear way, the proximal end parts of the branched pipes are in an arc shape, the proximal ends of the branched pipes are gradually folded and connected into the distal end of an end pipe, the outer surfaces of the branched pipes are provided with at least two ring electrodes, the number of the ring electrodes of each branched pipe is the same, and the outer surface of the catheter is sleeved with a protective pipe which is in. Compared with the prior art, the invention can quickly and safely carry out high-density mapping in the whole heart chamber of the heart, the protecting and delivering tube conveniently pushes the branch tube to the far end, the sensor can realize the positioning of the catheter, and the three-dimensional imaging of the heart chamber of a patient can be directly and quickly carried out through the three-dimensional cardiac electrophysiology mapping of the computer, thereby completing the three-dimensional modeling, greatly increasing the effectiveness and operability of the operation and saving the operation time.

Description

Rake-shaped head end high-precision multi-polar mapping electrode catheter

Technical Field

The invention relates to a medical surgical instrument, in particular to an electrode catheter for cardiac electrophysiology mapping.

Background

Since birth, the intracardiac electrophysiological mapping method has been the gold standard for arrhythmia disease diagnosis, has become the main treatment means along with drug treatment since the popularization of the radiofrequency ablation method and other treatment methods, and has developed rapidly in the last 10 years. Common conditions that have been treated with radiofrequency ablation include atrial fibrillation, paroxysmal supraventricular tachycardia, ventricular premature beats, ventricular tachycardia and most tachyarrhythmias. In the common and complicated radio frequency ablation process such as atrial fibrillation and ventricular tachycardia, with the further research and practice, it is increasingly important to accurately map the location of abnormal electrical activity, and various methods and devices for high-precision mapping are rapidly developed and matured.

The cardiac electrophysiology method in the prior art acquires structural information in a human body through X-ray imaging or contrast imaging, the method increases the exposure time of a patient to X-rays, increases the dosage of a contrast agent, is easy to cause injury to the patient, and the formed image is a two-dimensional image which is difficult to identify by a doctor, inconvenient to operate and difficult to operate.

Disclosure of Invention

The invention aims to provide a rake-shaped head end high-precision multi-electrode mapping electrode catheter, and aims to solve the technical problems of improving the precision of mapping signals, reducing the operation difficulty and improving the operation efficiency.

The invention adopts the following technical scheme: a harrow-shaped head-end high-precision multi-electrode mapping electrode catheter is provided with a catheter, wherein 2-8 branched pipes are arranged at the far end of the catheter, the far end parts of the branched pipes are linearly arranged in parallel, the near end parts of the branched pipes are arc-shaped, the near ends of the branched pipes are gradually folded and connected into the far end of an end pipe, at least two ring electrodes are arranged on the outer surface of each branched pipe, the number of the ring electrodes of each branched pipe is the same, and a protecting pipe is sleeved on the outer surface of the catheter and forms intermittent matching with.

The branch pipe of the invention is internally provided with a shaping wire with a memory function.

The number of the branched pipes is 4, 4 ring electrodes are arranged on the surfaces of the branched pipes, and the ring electrodes on the surfaces of the 4 branched pipes are orthogonally arranged at equal intervals of 4 × 4.

The first branch pipe and the fourth branch pipe are the same in shape and are symmetrically distributed, and the second branch pipe and the third branch pipe are the same in shape and are symmetrically distributed.

The outer surface of the near end of the first branch pipe is provided with an identification ring.

The outer surface of the end tube is provided with at least one tube body electrode.

A shaping die is arranged in the far end of the end tube, the shaping die is cylindrical, 4 shaping wire through holes and saline tube through holes are formed along the axis of the shaping die, and the shaping wire through holes are uniformly distributed in a straight line on the same diameter.

A brine pipe is fixedly arranged in the brine pipe through hole, and the far end face of the brine pipe reaches the far end face of the sizing die.

A sensor A for sensing the position is arranged in the inner cavity of the end tube close to the near end of the sizing die (34).

The sensor A of the invention adopts an electromagnetic sensor.

Compared with the prior art, the invention is provided with the branch pipes with the distal end parts arranged in parallel in a straight line shape and the proximal end parts in an arc shape at the far end of the catheter, the near ends of the branch pipes are gradually furled and connected into the far end of the end pipe, the outer surface of the branch pipe is provided with at least two ring electrodes, the number of the ring electrodes of each branch pipe is the same, high-density mapping in the whole heart chamber of the heart can be quickly and safely carried out, the outer surface of the catheter is sleeved with a protective pipe, the branch pipes are conveniently pushed to the far end, the far end of the catheter is provided with a sensor, the positioning of the catheter can be realized, the three-dimensional imaging of the heart chamber of a patient can be directly and quickly carried out by the three-dimensional heart electrophysiology mapping technology of a.

Drawings

Fig. 1 is a schematic structural view of the present invention.

Fig. 2 is a schematic diagram of the head end structure of the present invention.

FIG. 3 is a schematic cross-sectional view of a branched pipe of the present invention.

Fig. 4 is a schematic cross-sectional view of a sizing die of the present invention.

Fig. 5 is an axial cross-sectional view of an end tube of the present invention.

Figure 6 is a schematic cross-sectional view of a three-hole tube of the present invention.

Figure 7 is an axial cross-sectional view of the catheter shaft of the present invention.

Fig. 8 is a schematic view of the structure of the handle device of the present invention.

Fig. 9 is a schematic representation of a bipolar electrogram formed by two adjacent ring electrodes of the present invention.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples.

As shown in fig. 1, the rake-shaped head-end high-precision multi-polar mapping electrode catheter of the present invention is provided with a catheter 2 and a handle device 1 connected in sequence from a distal end to a proximal end, and the proximal end of the handle device 1 is connected with a connector 7 and a saline pipe joint 9.

The catheter 2 is provided with a head end 3, a three-hole tube 4 and a catheter tube body 5 which are connected in sequence from the distal end to the proximal end. The catheter 2 is externally sleeved with a protective tube 6, and the protective tube 6 is sleeved outside the catheter body 5 in a non-working state.

As shown in fig. 2, in the present embodiment, the head end 3 is formed by connecting a distal branch pipe 31 and a proximal end pipe 35, and the distal end is in the shape of a four-arm rake. The branch pipes 31 are 4 with distal end parts arranged in parallel linearly and proximal end parts in arc shape, and the proximal end parts are gradually furled and connected in the distal end of the end pipe 35 to form a rake shape. A sizing die 34 is disposed within the distal end of the end tube 35. The branch pipes 31 are arranged in this order from top to bottom as shown in the drawing, and are respectively provided as first to fourth branch pipes for distinction. The first branch pipe and the fourth branch pipe are same in shape and are symmetrically distributed, and the second branch pipe and the third branch pipe are same in shape and are symmetrically distributed. An annular identification ring 36 is provided on the proximal outer surface of the first branch pipe 31 to identify the first branch pipe. The number of the branched pipes 31 may be 2-8 according to the clinical requirement.

As shown in fig. 3, the branch tube 31 is tubular, a shaping wire 32 is provided in the lumen, and the shaping wire 32 is made of a nickel-titanium alloy wire and shaped into a shape having a linear distal end portion and an arc-shaped proximal end portion by a conventional thermoforming method. The shaping wire 32 has a good memory function and can shape the shape of the branch pipe 31 well. The distal end of the branch pipe 31 is a smooth hemisphere to form a sealing structure with the branch pipe 31. The inner diameter of the branch pipe 31 is 0.4-1.0 mm, the outer diameter is 0.6-1.2 mm, and the length is 15-25 mm. The diameter of the shaping wire 32 is 0.07-0.15 mm, the length is consistent with that of the branch pipe 31, the far end and the branch pipe are fixed in a hemisphere by glue, and the near end is arranged in the through hole 341 of the shaping mold 34.

As shown in fig. 4, the shaping mold 34 is cylindrical, and has 4 shaping thread through holes 341, 1 guide line through hole 342, 1 saline pipe through hole 343, and 6 through holes parallel to the axis of the shaping mold, wherein the 4 shaping thread through holes 341 are uniformly distributed in a straight line on the same diameter for fixing the proximal ends of the 4 branch pipes 31, so that the 4 branch pipes 31 are distributed in a plane. The two sides of the central connecting line of the shaping wire through hole 341 are symmetrically provided with a lead through hole 342 and a saline pipe through hole 343.

The outer surface of the branch pipe 31 is provided with at least two annular ring electrodes 33, the number of the ring electrodes 33 of each branch pipe 31 is the same, in the embodiment, the surface of the branch pipe 31 is provided with 4

ring electrodes

33, 16 ring electrodes 33 on the surfaces of the first to fourth branch pipes 31 are orthogonally arranged at equal intervals of 4 × 4, as shown in fig. 9, every two adjacent ring electrodes form a pair of bipolar electrograms along the axial direction and the radial direction of the branch pipe, and the total number of the bipolar electrograms is 24 pairs, therefore, the electrocardiogram of the same point in the heart can synchronously record intracardiac electric signals from two orthogonal directions, the inner diameter of the ring electrodes 33 is 0.8-1.2 mm, the outer diameter is 0.9-1.3 mm, and the width is 0.5-1 mm.

The inner side of the ring electrode 33 is connected with the far end of a lead 331, the lead 331 passes through the lumen of the branch pipe 31, the lead through hole 342 of the sizing die, the inner cavity of the end pipe 35, the third lumen 43 of the three-hole pipe 4, the inner cavity of the catheter tube body 5 and the inside of the handle device 1, and the near end of the lead 331 is connected with the connector 7.

The ring electrode 33 and the identification ring 36 are made of platinum-iridium alloy or gold. The conducting wire 331 is a copper wire with a diameter of 0.1-0.2 mm.

Be provided with brine pipe 91 in the brine pipe through-hole 343, adopt glue to fix brine pipe 91 in brine pipe through-hole 343, brine pipe 91 distal end terminal surface to stock mould 34 distal end terminal surface flushes with stock mould 34 distal end terminal surface. The saline pipe 91 passes through the inner cavity of the end pipe 35, the second lumen 42 of the three-hole pipe 4, the inner cavity of the catheter tube body 5 and the handle device 1, and the proximal end of the saline pipe 91 is connected with the saline pipe joint 9.

As shown in fig. 5, the end tube 35 is tubular, and the sizing die 34 is fixed to the distal end of the inner cavity of the end tube 35 by glue and is flush with the distal end surface of the end tube 35. The end pipe 35 is made of block polyether amide resin PEBAX, polyurethane, block polyamide or nylon. The end pipe 35 has an outer diameter of 2 to 2.7mm, an inner diameter of 1 to 2mm, and a length of 5 to 15 mm.

The inner cavity of the end tube 35 is provided with a sensor A for sensing the position at a position close to the proximal end of the stock mould 34. The lead wire connecting the sensor a passes through the lumen of the end tube 35, the second lumen 42 of the three-hole tube 4, the lumen of the catheter shaft 5, the interior of the handle device 1 to the connector 7. The diameter of the sensor A is 0.8-1 mm, the length is 5-10 mm, and an electromagnetic sensor is adopted in the embodiment.

The outer surface of the end tube 35 is provided with at least one annular shaft electrode 37 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 shaft electrode lead 331 connected to the inside of the shaft electrode 37 is connected to the connector 7 through the inner cavity of the tip tube 35, the third lumen 43 of the three-hole tube 4, the inner cavity of the catheter shaft 5, and the inside of the handle device 1. The tube body electrode 37 adopts platinum iridium alloy or gold. The tube body electrode lead 331 adopts a copper wire with the diameter of 0.1-0.2 mm.

As shown in fig. 6, the three-hole tube 4 is tubular, and three through holes, namely a first tube cavity 41, a second tube cavity 42 and a third tube cavity 43, are axially formed, and the axes of the through holes are parallel to the axis of the three-hole tube 4. The second lumen 42 and the third lumen 43 are both arranged on the diameter connecting line of the three-hole tube 4, and the first lumen 41 is positioned at one side of the connecting line of the second lumen 42 and the third lumen 43. The first, second and

third lumens

41, 42, 43 communicate with the inner lumens of the tip tube 35 and the catheter shaft 5.

The outer diameter of the three-hole pipe 4 is 2-2.7 mm, the length is 50-100 mm, the inner diameter of the first pipe cavity 41 is 0.2-0.8 mm, and the inner diameters of the second pipe cavity 42 and the third pipe cavity 43 are consistent and are 0.5-1.2 mm.

The three-hole pipe 4 is made of block polyether amide resin PEBAX, polyurethane, block polyamide or nylon and has elasticity, so that the bending degree of the three-hole pipe 4 can be adjusted through the handle device 1.

A pull wire steel wire B penetrates through the first lumen 41 of the three-hole tube 4, and the surface of the pull wire steel wire B is coated with a pull wire outer tube B1 for preventing the pull wire steel wire B from generating friction with the inner wall of the first lumen 41 in the pulling process to influence the bending shape of the catheter 2. The far end of the stay wire steel wire B is connected with the end pipe 35, the far end of the stay wire steel wire B is connected with a riveting pipe B2 in a welding mode, the surface of the riveting pipe B2 is coated with a riveting pipe sleeve B3, and the riveting pipe B2 is arranged at the heat welding position of the near end of the inner cavity of the end pipe 35 and the three-hole pipe. The pull wire steel wire B passes through the first lumen 41 of the three-hole tube 4, the inner cavity of the catheter tube body 5, the handle device 1 and the proximal end is connected with the connector 7. Rivet B2 is 304 stainless steel.

The second lumen 42 of the three-hole tube 4 has a lead wire of the sensor a and a saline tube 91 passing therethrough.

The third lumen 43 of the three-hole tube 4 is penetrated by a lead 331 and a tube body electrode lead 331.

As shown in fig. 7, the catheter shaft 5 is tubular. The distal end of the catheter tube body 5 is connected with the three-hole tube 4, and the proximal end is connected with the distal end of the handle device 1.

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

The outer surface of the catheter tube body 5 is sleeved with the protecting tube 6, the protecting tube 6 is tubular and is in intermittent fit with the end tube 35, the three-hole tube 4 and the catheter tube body 5, when the protecting tube 6 is pushed to the far end along the catheter tube body 5, the 4 branch tubes 31 can be folded in the protecting tube, and therefore an operating doctor can conveniently push the far end of the catheter 2 into a human blood vessel mapping part smoothly.

As shown in fig. 8, the handle device 1 is provided with a handle case 12 in the form of a revolving body provided with a through hole 11 coaxial therewith.

The outer edge of the far end of the handle shell 12 is connected with a handle cover 13 in a threaded mode, the axial section of the handle cover 13 is concave, and the end face faces the far end and is provided with a handle cover hole 14 which is coaxial with the through hole 11.

The handle device 1 is provided with a cylindrical push rod 15, the push rod 15 is provided with a push rod through hole 154 coaxial with the push rod 15, the outer edge of the push rod 15 is provided with a push handle 151 protruding outwards, and the push handle 151 divides the push rod 15 into a far end rod part 152 and a near end rod part 153. The proximal shaft 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, so that the proximal shaft portion 153 is disposed in the distal end of the through hole 11 of the handle housing 12.

The outer peripheral wall of the proximal rod part 153 is provided with a guide groove 155 parallel to the axis of the handle housing 12, the peripheral wall of the distal end of the handle housing 12 is provided with a limit screw hole 111 corresponding to the position of the guide groove 155 and communicated with the through hole 11, and the lower end of a limit bolt 16 in threaded connection with the limit screw hole 111 extends into the guide groove 155 to limit the axial moving position of the push rod 15.

A locking nut 17 is threadedly attached to the distal end of the distal shaft portion 152 to fixedly attach the proximal end of the catheter shaft 5 within the lumen distal of the pusher through bore 154.

A handle inner core 18 which is cylindrical in shape is arranged in the near end of the through hole 11, an inner core through hole 181 is formed in the handle inner core 18 along the axis of the through hole 11, a first screw hole 182 which is perpendicular to and communicated with the inner core through hole 181 is formed in the outer peripheral wall of the handle inner core 18, and a second screw hole 112 is formed in the peripheral wall of the near end of the handle shell 12. The first screw hole 182 and the second screw hole 112 are threadedly coupled to a wire fixing post 19. The lower end of the steel wire fixing column 19 is provided with a steel wire positioning column through hole 191 communicated with the inner core through hole 181, and the axis of the steel wire positioning column through hole 191 is vertical to the axis of the steel wire fixing column 19.

After the pull wire steel wire B passes through the first lumen 41 of the three-hole tube 4 and the catheter tube body 5, the proximal end of the pull wire steel wire B passes through the push rod through hole 154, the distal end part of the inner core through hole 181, the steel wire positioning column through hole 191 and the proximal end part of the inner core through hole 182, the steel wire fixing column 19 is rotated, so that the steel wire positioning column through hole 191 and the inner core through hole 181 are staggered, and the proximal end of the pull wire steel wire.

The pushing handle 151 of the pushing rod 15 is pushed to the far end along the axial direction, the pushing rod 15 extends out of the far end of the handle shell 12, the length of the stay wire steel wire B is unchanged, and the three-hole pipe 4 is bent. The bending degree of three-hole pipe 4 can be adjusted to the propelling-out distance of propelling push rod 15, and the concrete process is:

the pull wire steel wire B penetrates through the first tube cavity 41 of the three-hole tube 4, and because the first tube cavity 41 is an eccentric hole deviating from the axis of the catheter 2, in the assembly process of the catheter 2, the near end face of the three-hole tube 4 and the far end face of the catheter 5 are fixedly connected through a thermal fusion process, the riveting tube B2 at the far end of the pull wire steel wire B is fixedly connected with glue in the inner cavity of the end tube 35, and after the near end of the pull wire steel wire B is fixedly connected with the handle inner core 18, the length of the pull wire steel wire B is fixed. When the pushing rod 15 is pushed in the axial direction, the pushing force of the pushing rod 15 causes the three-hole tube 4 to bend proximally by the pulling wire B because of the elasticity of the three-hole tube 4. The bending angle of the three-hole pipe 4 can be adjusted by controlling the length of the stay wire steel wire B.

The use method of the invention comprises the following steps: the protection tube 6 is pushed to the far end along the

catheter

2, 4 branch tubes 31 are collected in the protection tube, the far end of the rake-shaped head end high-precision multi-pole mapping electrode catheter is pushed into a heart cavity from a femoral artery, the handle device 1 is operated to control the three-hole tube 4 to bend, the head end 3 and the three-hole tube 4 smoothly enter the heart, the protection tube 6 is withdrawn to the near end along the catheter 2, the branch tubes 31 are released, ring electrodes 33 on the branch tubes 31 are attached to the inner wall of the heart, the electrocardio physiological information of each point is obtained, and the electrocardio physiological information is fed back to the three-dimensional mapping system. The sensor A arranged in the inner cavity of the end tube 35 can carry out three-dimensional modeling on the catheter, and by utilizing the sensor A and the magnetic field generator under the operating table, the electrophysiology mapping navigation system can accurately position and acquire the coordinate data of the far end of the catheter, so that the far end of the catheter can be positioned.

The invention is attached to the heart tissue through the ring electrode 33 on the outer surface of the branch pipe 31 with the rake-shaped structure at the distal end, and the intracardiac electric signals are transmitted to the electrophysiology mapping navigation system through the ring electrode 33, the lead wire 331 and the connector 7. To avoid thrombus formation during the mapping procedure, anticoagulant is injected and flows through the saline tube 91 via the proximal saline tube fitting 9 to the intracardiac mapping site.

The invention can quickly and safely carry out high-density mapping in the whole heart chamber of the heart, the ring electrodes 33 are orthogonally arranged at equal intervals by the rake-shaped structure to form 24 pairs of bipolar electrograms, the electrocardiogram at the same point in the heart can synchronously record intracardiac electric signals from two directions, and information omission caused by different intracardiac current conducting directions in the prior art is avoided.

According to the invention, the sensor A is arranged in the inner cavity of the end tube 35, so that the distal end of the catheter can be positioned and navigated, the mapping and modeling of the three-dimensional anatomical structure of the heart can be rapidly realized by matching with a three-dimensional mapping system, the effectiveness and operability of the operation are greatly improved clinically, and the operation time is saved. When the sensor A is not used, the two-dimensional mapping can be carried out on the heart cavity by matching with a plurality of electrophysiology instruments, so that the invention has multiple purposes.

Claims

1. A harrow form head end high accuracy multipolar mapping electrode pipe is equipped with pipe (2), its characterized in that: the far end of pipe (2) is equipped with 2 ~ 8 distal parts and is the linear parallel arrangement, and the proximal part is circular-arc lateral pipe (31), and the near end of lateral pipe (31) gradually draws in and connects in the distal end of end pipe (35), and lateral pipe (31) surface is equipped with two at least ring electrodes (33), and the ring electrode (33) of each lateral pipe (31) quantity is the same, catheter (2) surface cover has been put and has been protected tub (6), and it forms intermittent type cooperation with pipe (2).

2. The rake-head high-precision multi-polar mapping electrode catheter of claim 1, wherein: the branch pipe (31) is internally provided with a shaping wire (32) with a memory function.

3. The harrow-shaped head-end high-precision multi-polar mapping electrode catheter as claimed in claim 2, wherein the number of the branch pipes (31) is 4, 4 ring electrodes (33) are arranged on the surface of each branch pipe (31), and the ring electrodes (33) on the surfaces of the 4 branch pipes (31) are orthogonally arranged at equal intervals of 4 × 4.

4. The rake-head high-precision multi-polar mapping electrode catheter of claim 3, wherein: the first branch pipe (31) and the fourth branch pipe (31) are same in shape and are symmetrically distributed, and the second branch pipe (31) and the third branch pipe (31) are same in shape and are symmetrically distributed.

5. The rake-head high-precision multi-polar mapping electrode catheter of claim 4, wherein: the outer surface of the proximal end of the first branch pipe (31) is provided with an identification ring (36).

6. The rake-head high-precision multi-polar mapping electrode catheter of claim 5, wherein: the outer surface of the end pipe (35) is provided with at least one pipe body electrode (37).

7. The rake-head high-precision multi-polar mapping electrode catheter of claim 6, wherein: be provided with stock mould (34) in the distal end of end pipe (35), stock mould (34) shape is cylindric, has opened 4 stock silk through-holes (341) and brine pipe through-hole (343) along its axis, and stock silk through-hole (341) are word evenly distributed on same diameter.

8. The rake-head high-precision multi-polar mapping electrode catheter of claim 7, wherein: saline pipe (91) is fixedly arranged in the saline pipe through hole (343), and the distal end face of the saline pipe (91) reaches the distal end face of the sizing die (34).

9. The rake-head high-precision multi-polar mapping electrode catheter of claim 8, wherein: and a sensor A for sensing the position is arranged at the position, close to the near end of the sizing die (34), of the inner cavity of the end pipe (35).

10. The rake-head high-precision multi-polar mapping electrode catheter of claim 9, wherein: the sensor A adopts an electromagnetic sensor.