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Space bent spiral multi-ring pulmonary vein ablation catheter
Description
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Technical Field
The invention relates to a medical surgical instrument, in particular to a pulmonary vein radiofrequency ablation catheter.
Background
Atrial fibrillation (atriafibrillation) is the most common type of atrial tachyarrhythmia in the clinic, and electrical activity from the heart muscle cells causes the patient to lose normal sinus impulses, causing irregular contractions of the atria, resulting in loss of atrial assist pump function. Not only will atrial fibrillation become more severe with age, but it will also increase the incidence of stroke and, when complicated by other cardiovascular diseases, the mortality of the patient will also increase.
With the development of intracardiac electrophysiology, it has become recognized that some atrial fibrillation originates from the pulmonary vein cuff. As early as 1966, researchers discovered that striped cardiac muscle was deep in the pulmonary veins, and subsequently discovered that these cardiac muscle were capable of generating action potentials in 1981, Haissaguerre et al thought that pulmonary veins may be involved in the onset of atrial fibrillation as the origin of ectopic impulses, and discovered that 94% of drug-insensitive atrial fibrillation originating in the pulmonary veins had ectopic activity in the pulmonary veins, and that atrial fibrillation disappeared after ablation of these pulmonary vein sites. Chen et al found in 2000 that pulmonary vein myocardial tissue was autonomous and focused primarily on the ostium. In 2003, 100% of patients with atrial fibrillation were found to have pulmonary vein muscle cuffs, while those without atrial fibrillation had only 85% of the total weight, and subsequently, with vascular ultrasound, patients with atrial fibrillation had thick pulmonary vein muscle tissue and arrhythmia was likely to occur in these thick layers of myocardium. It is now generally accepted that these heart muscle tissues with autonomy produce atrial premature, followed by atrial fibrillation. Because most of atrial fibrillation originates from pulmonary veins, the current popular means for treating atrial fibrillation is pulmonary vein isolation, and tissues forming atrial fibrillation inducers in cardiac muscles are ablated by energy released by a catheter tip end electrode entering the left atrium so as not to be connected with other cardiac muscles.
Since the pulmonary veins have four branches, the shapes and inner diameters of the four branches are different, and the individual differences also exist between people. The pulmonary vein ablation catheter in the prior art is mainly structured by matching a straight catheter with a single-ring catheter, and the catheter with the structure has the defects that the ablation range is small, the operation needs to be performed for several times, the limitation is strong, and the catheter cannot be applied to a plurality of positions or structural problems, so that the operation is not simple and convenient.
Disclosure of Invention
The invention aims to provide a space curved spiral multi-ring pulmonary vein ablation catheter, and aims to improve the adaptability of the pulmonary vein ablation catheter and facilitate the operation of doctors.
The invention adopts the following technical scheme: a space curved spiral multi-ring pulmonary vein ablation catheter is provided with a double-hole tube, wherein the far end of the double-hole tube is connected with a spiral multi-ring part, the spiral multi-ring part is in a tubular shape and is in a shape of a disc-shaped concentric multi-ring or a shape of annular connection of at least two openings with opposite annular bending directions in the same plane, and the plane formed by the shape of annular connection of at least two openings with opposite annular bending directions in the disc-shaped concentric multi-ring or the same plane is vertical or approximately vertical to the axial lines of a tube body and the double-hole tube and is in a straight line or approximately straight line after being stretched; the tubular spiral multi-ring part is externally sleeved or embedded with a ring electrode at intervals.
The central end of the disk-like concentric multi-ring shape of the present invention is connected to the distal end of the double bore tube.
The center distance of each ring of the spiral multi-ring part is 0-40 mm.
The center distance of each ring of the spiral multi-ring part is 0-30 mm.
The spiral multi-ring part has the outer diameter of 0.38-4.05 mm and the inner diameter of 0.33-4 mm.
The spiral multi-ring part has the outer diameter of 1.05-3.05 mm and the inner diameter of 1-3 mm.
The tubes of the spiral polycyclic portion of the present invention are made of polyurethane, block polyetheramide resin or nylon.
The spiral multi-ring part is internally provided with a shaped steel wire, and the shaped steel wire is in a shape of annular connection of at least two openings with opposite bending directions, wherein the annular connection is formed in a disc-shaped concentric multi-ring or in the same plane; the shaping wire is a nickel-titanium wire, a copper-aluminum-nickel alloy wire, a copper-aluminum-zinc alloy wire, an iron-platinum alloy wire, an iron-palladium alloy wire, an iron-nickel-cobalt-titanium alloy wire or an iron-manganese-silicon alloy wire, the outer diameter of the shaping wire is 0.1-0.7 mm, the diameter of an inner ring of the shaping wire is 5-40 mm, and the outer diameter of an outermost ring of the shaping wire is 10-70 mmm.
The outer diameter of the sizing wire is 0.4-0.46 mm, the diameter of the inner ring of the sizing wire is 10-20 mm, and the outer diameter of the outermost ring is 20-40 mm.
The ring shape of the spiral multi-ring part is 2-5 circles.
Compared with the prior art, the spiral multi-ring part adopts an open multi-ring structure, has good adaptability to different pulmonary vein orifices and other myocardial tissues, can carry out mapping and/or ablation, has the ring electrodes tightly attached to the pulmonary veins or other myocardial tissues, has stable electrophysiological signal acquisition and simple and convenient operation, reduces the use number of catheters, ensures that the operation is safer and faster, greatly increases the effectiveness and operability of the operation clinically, improves the operation efficiency and reduces the burden of patients.
Drawings
Fig. 1 is a schematic structural view of the present invention.
FIG. 2 is a schematic diagram of the present invention with zero pitch of the spiral shape of the spiral multiple ring portion.
Fig. 3 is a schematic view of a bent structure of the double-hole pipe of the present invention.
FIG. 4 is a schematic view of the configuration of the present invention with the distal end of the dual bore tube bent 180 and the spacing of the disk-like spirals being zero.
FIG. 5 is a schematic view of the handle and connector connection of the present invention.
Fig. 6 is a schematic view of the structure of the shaped steel wire of the present invention.
FIG. 7 is a schematic diagram of the structure of the twin-well tube of the present invention.
Fig. 8 is an axial cross-sectional view of a catheter of the present invention.
Fig. 9 is a schematic view of the structure of the handle device 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 figure 1, the space curved spiral multi-ring pulmonary vein ablation catheter of the invention is provided with a catheter 2, a handle device 1 and a connector 7 which are connected in sequence from the far end to the near end.
The catheter 2 is provided with a catheter body 5, the proximal end of the catheter body 5 is connected with the handle device 1, the distal end of the catheter body 5 is connected with the proximal end of the double-hole tube 4, and the distal end of the double-hole tube 4 is connected with the spiral multi-ring part 6.
The spiral multi-ring part 6 is tubular and is wound into the shape of a disc-shaped concentric multi-ring, in a free state, the plane formed by the disc-shaped concentric multi-ring is vertical or approximately vertical to the axes of the tube body 5 and the double-hole tube 4, and the central end part of the tubular spiral multi-ring part 6 is connected with the far end of the double-hole tube 4. The spiral multi-ring part 6 can also be wound in the shape of a ring connection of at least two openings in the same plane, wherein the bending direction of the ring is opposite to that of the adjacent ring. The center distance of each ring shape of the spiral multi-ring part 6 is 0-40 mm, preferably 0-30 mm.
The spiral multi-ring part 6 is 2-5 circles in ring shape.
The spiral multi-ring part 6 has an outer diameter of 0.38 to 4.05mm, preferably 1.05 to 3.05mm, and an inner diameter of 0.33 to 4mm, preferably 1 to 3 mm. The tube of the spiral polycyclic part 6 is made of polyurethane PU, block polyether amide resin PEBAX or nylon.
The tubular spiral multi-ring part 6 is sleeved or embedded with the ring electrode 3 at intervals. The inner diameter of the ring electrode 3 is 0.33 to 4mm, preferably 1 to 3mm, and the outer diameter is 0.38 to 4.05mm, preferably 1.05 to 3.05mm, and the width is 0.2 to 4mm, preferably 1 to 3 mm. The ring electrode 3 adopts platinum iridium alloy or gold.
The ring electrode 3 is used for mapping or ablation.
As shown in fig. 2, a smaller flat surface is formed when the spacing between the loops of the helical multi-loop portion 6 is reduced to zero.
The spiral multi-ring part 6 can be collected in the PV conveying protecting pipe 19 by adopting a vinyl chloride resin PV conveying protecting pipe 19 in the prior art, which is equivalent to that the spiral multi-ring part 6 is in a straight line or an approximate straight line after being stretched, and after the PV conveying protecting pipe 19 is withdrawn, the spiral multi-ring part 6 is released to be in a free state and is in a shape of a disc-shaped concentric multi-ring or at least two openings with opposite bending directions in the same plane are connected in an annular mode.
As shown in fig. 3, the distal end of the double bore tube 4 may be adjusted to bend proximally by 180 °.
As shown in fig. 4, the distal end of the double-bore tube 4 is adjusted to a 180 ° bend, and the minor plane is perpendicular to the tube body 5 when the spacing between the loops of the helical multi-loop portion 6 is reduced to zero.
As shown in fig. 5, the connector 7 may be disposed at the proximal end of the handle device 1 through an extension wire, or may be disposed inside the handle device 1. The extension line is a connection line of the handle device 1 and the connector 7.
As shown in fig. 6, a shaped wire 61 is provided inside the tube of the spiral multi-ring portion 6, and the shaped wire 61 has a disc-like concentric multi-ring shape. The shaped wire 61 may also be in the form of a loop connection of at least two openings in the same plane, wherein the loop is bent in the opposite direction to its neighboring loop.
The shaping wire 61 has superelasticity, and can be a nickel-titanium wire shaped by heat treatment of a die according to the prior art, and also can be a copper-aluminum-nickel alloy wire, a copper-aluminum-zinc alloy wire, an iron-platinum alloy wire, an iron-palladium alloy wire, an iron-nickel-cobalt-titanium alloy wire or an iron-manganese-silicon alloy wire. The outer diameter of the shaping wire 61 is 0.1-0.7 mm, preferably 0.4-0.46 mm, the diameter of the inner ring of the shaping wire 61 is 5-40 mm, preferably 10-20 mm, and the outer diameter of the outermost ring is 10-70 mm, preferably 20-40 mm. The number of the shaping wire 61 is 2-5 circles.
As shown in fig. 7, the double-hole tube 4 is cylindrical, two tube cavities are provided therein, which are a first tube cavity 41 and a second tube cavity 42, respectively, the first tube cavity 41 and the second tube cavity 42 are through holes, and the axes of the first tube cavity 41 and the second tube cavity 42 are parallel to the axis of the cylindrical double-hole tube 4, respectively, and are communicated with the inner cavity of the tube body 5.
The outer diameter of the double-hole tube 4 is 1-3.7 mm, preferably 1.6-2.7 mm, the length is 20-200 mm, preferably 50-100 mm, the inner diameter of the first tube cavity 41 is 0.3-1.5 mm, preferably 0.75-0.85 mm, and the inner diameter of the second tube cavity 42 is 0.2-1.4 mm, preferably 0.6-0.7 mm.
The double-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 double-hole pipe 4 can be adjusted through the handle device 1.
A guide wire passes through the first lumen 41 of the double-hole tube 4.
The inner side of the ring electrode 3 sleeved at intervals on the spiral multi-ring part 6 is connected with a lead wire, and the lead wire is electrically connected with the connector 7 through the first tube cavity 41, the tube body 5 and the handle device 1. The wire is a copper wire with a diameter of 0.01-0.5 mm, preferably 0.1-0.2 mm. The copper wire is coated with a coating layer, and the insulating strength of the coating layer is not lower than 500V, preferably not lower than 2000V.
The second lumen 42 of the double-hole tube 4 is penetrated with a stay wire steel wire 8 and a riveting tube 9.
The far-end of the stay wire steel wire 8 is welded with the near end of the riveting tube 9, and the far end of the riveting tube 9 is welded with the central end of the shaping steel wire 61. The surface of the stay wire steel wire 8 is coated with an outer tube 10. The surface of the riveting tube 9 is coated with a sleeve 91. The rivet tube 9 is arranged at the far end face of the second tube cavity 42.
As shown in fig. 8, the tube body 5 is tubular. The proximal end of the tube body 5 is connected with the distal end of the handle device 1, and the distal end of the tube body 5 is connected with the double-hole tube 4.
The outer diameter of the pipe body 5 is 0.8-5.4 mm, preferably 1.6-2.7 mm, the inner diameter is 0.5-4 mm, preferably 1-2 mm, the length is 400-2100 mm, preferably 800-1050 mm.
The pipe body 5 is made of PEBAX, polyurethane, block polyamide or nylon, and a stainless steel wire net 51 is embedded in the pipe wall of the pipe body 5 according to the prior art (patent application No. 202020703562.3).
As shown in fig. 9, the handle device 1 according to the prior art (patent application No. 202020703562.3) is provided with a handle case 12 in the form of a rotary body having a through hole 11 formed coaxially therewith, a handle cover 13 screwed to the distal outer edge of the handle case 12, and a handle cover hole 14 formed coaxially with the through hole 11 in the handle cover 13. A push rod 15 is arranged in the far end of the handle shell 12, and the push rod 15 extends out of the far end of the handle cover 13.
The handle device 1 is provided with a limiting bolt 16, a locking nut 17 and a steel wire fixing column 18. The push rod 15 is controlled in its extent of axial movement within the handle housing 12 by a stop bolt 16. The near end of the tube body 5 is fixed on the push rod 15 by a lock nut 17, and the stay wire steel wire 8 passes through the second tube cavity 42 and the tube body 5 and then passes through the through hole 11 of the handle shell 12 to be connected with the steel wire fixing column 18.
The push rod 15 is pushed to the far end along the axial direction, the push rod 15 extends out of the handle shell 12, the length of the tube body 5 and the handle device 1 is increased, the length of the stay wire steel wire 8 is unchanged, and the double-hole tube 4 is bent, so that the bending degree of the double-hole tube 4 is adjusted.
The use method of the invention comprises the following steps: the spiral multi-ring part 6 is contracted in the PV protecting and delivering tube 19 in a linear or approximately linear shape by adopting the PV protecting and delivering tube 19 in the prior art, namely, the spiral multi-ring part 6 is bound into a straight long tube by the PV protecting and delivering tube 19 and is pushed to a heart target from a femoral artery to be a pulmonary vein or other approximately planar part of the heart, after the spiral multi-ring part 6 enters a cardiac blood vessel along with the PV protecting and delivering tube 19, the PV protecting and delivering tube 19 is withdrawn towards the proximal end, the spiral multi-ring part 6 is restored to a free state, namely, the shape of concentric multi-ring or at least two opening annular connections with opposite bending directions is adopted, so that the rings of the spiral multi-ring part 6 can be tightly pressed and attached to the PV protecting and delivering tube, the bending of the double-ring tube 4 is adjusted by the handle device 1 to be attached to the target part needing ablation treatment, and the ring electrode 3 carries out potential mapping or discharge ablation. Under the thrust action of the pushing catheter 2, the ring shape of the spiral multi-ring part 6 generates extrusion deformation on the coronary pulmonary vein, and the ring electrodes 3 on the small ring and the large ring of the ring shape tightly cling to the ostium of the pulmonary vein; or to bring the helical multi-ring portion 6 tightly against flat myocardial tissue. Acquiring the electrocardio-physiological information of each tested point position, confirming the target position, and then carrying out ablation to isolate the connection between the pulmonary vein muscle sleeve and the myocardial tissue or to ablate other tissues.
When the target site is a substantially flat surface (substantially flat surface is a flat position of the inner wall of the atrium, similar to a plane), the bending of the double-hole tube 4 may be controlled by the handle means 1 such that the helical multi-ring part 6 abuts parallel to the target site. In this case, the ring electrodes 3 of the inner and outer rings can contact the target site tissue, and the operator can perform high-density mapping by using a plurality of ring electrodes 3 of the inner and outer rings, or can perform ablation by using the ring electrodes 3 of the outer ring to isolate the coverage area.
When the target part is a small diameter pulmonary vein (the caliber is smaller than the diameter of the annular inner ring), the bending of the double-hole tube 4 is adjusted by the handle device 1, so that the axis of the tube body 5 is coaxial or approximately coaxial with the axis of the entrance part of the pulmonary vein. Pushing the helical polycyclic section 6 into contact with the pulmonary vein entry site. At this time, the annular inner ring of the spiral multi-ring portion 6 is in contact with the pulmonary vein entrance, and the outer ring is in contact with the pulmonary vein vestibule (peripheral tissue of the pulmonary vein). Under the condition, an operator can perform high-density mapping by using the ring electrodes 3 of the inner ring and the outer ring, can use the ring electrodes 3 of the inner ring to ablate the entrance part of the pulmonary vein, and can use the ring electrodes 3 of the outer ring to ablate the vestibule of the pulmonary vein, thereby realizing a wide ablation injury zone. When the outer ring electrode 3 is used for ablation, the inner ring electrode 3 can also be used for observing the internal potential of the pulmonary vein.
When the target part is a large pulmonary vein (the caliber is larger than the inner ring and smaller than the outer ring), the handle device 1 is used for adjusting the bending of the double-hole tube 4, so that the axis of the tube body 5 is coaxial or approximately coaxial with the axis of the pulmonary vein inlet part. Pushing the helical polycyclic section 6 into contact with the pulmonary vein entry site. At this point, the inner circle of the helical multi-ring portion 6 will enter the interior of the pulmonary vein, while the outer circle will contact the entrance or vestibule of the pulmonary vein (depending on the difference in the pulmonary vein caliber and outer circle diameter). In this case, the operator can perform mapping using the plurality of ring electrodes 3 of the outer ring, and can observe the pulmonary vein internal potential using the ring electrodes 3 of the inner ring. All the ring electrodes 3 can be used for mapping and ablation, and each two ring electrodes 3 form a pair, and the ablation and mapping can be carried out at the same time, but not at the same time. The ring electrode 3 on the outer ring can be used for ablating the entrance part or the vestibule of the pulmonary vein.
After one ablation, the mapping mode can be switched. If the potential at the target site remains, the position of the helical multi-ring portion 6 can be rotated or adjusted to perform ablation again. Until the potential at the target site disappears completely.
According to the space curved spiral multi-ring pulmonary vein ablation catheter, the spiral multi-ring part 6 adopts a spiral multi-ring structure, the catheter has good adaptability for different pulmonary vein openings and other myocardial tissues, mapping and ablation can be performed, the mapping and ablation range is wide, the ring electrode 3 is tightly attached to the pulmonary vein or other myocardial tissues, electrophysiological signals are stably collected, the operation is simple and convenient, the number of the catheters is reduced, the operation is safer and quicker, the effectiveness and operability of the operation are greatly improved clinically, the operation difficulty of a doctor is reduced, the operation efficiency is improved, the operation time is saved, and the burden of a patient is reduced.
The catheter adopting the spiral multi-ring structure can not only map or melt the pulmonary veins, but also expand the application to the flat myocardial area of the back wall and the front wall of the left atrium, so that the space-bending spiral multi-ring pulmonary vein ablation catheter can adapt to various conditions. The invention can place more ring electrodes 3 on the spiral multi-ring part 6, realize high-density mapping, provide more information for operators and assist in accurately finding ablation targets.
Claims (10)
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Claims (10)
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1. The utility model provides a curved spiral polycyclic pulmonary vein ablation catheter in space is equipped with diplopore pipe (4), its characterized in that: the far end of the double-hole pipe (4) is connected with a spiral multi-ring part (6), the spiral multi-ring part (6) is tubular and is in a shape of a disc-shaped concentric multi-ring or a shape that an annular is connected with at least two openings with opposite bending directions of the adjacent annular in the same plane, and a plane formed by the disc-shaped concentric multi-ring or the shape that the annular is connected with at least two openings with opposite bending directions of the adjacent annular in the same plane is vertical or approximately vertical to the axial lines of the pipe body (5) and the double-hole pipe (4) and is linear or approximately linear after being stretched; the tubular spiral multi-ring part (6) is sleeved or embedded with a ring electrode (3) at intervals.
2. The spatially curved helical polycyclic pulmonary vein ablation catheter of claim 1, wherein: the central end of the disc-shaped concentric multi-ring shape is connected to the distal end of the double-bore tube (4).
3. The spatially curved helical polycyclic pulmonary vein ablation catheter of claim 1 or 2, wherein: the center distance of each ring of the spiral multi-ring part (6) is 0-40 mm.
4. The spatially curved helical polycyclic pulmonary vein ablation catheter of claim 3, wherein: the center distance of each ring of the spiral multi-ring part (6) is 0-30 mm.
5. The spatially curved helical polycyclic pulmonary vein ablation catheter of claim 4, wherein: the outer diameter of the spiral multi-ring part (6) is 0.38-4.05 mm, and the inner diameter is 0.33-4 mm.
6. The spatially curved helical polycyclic pulmonary vein ablation catheter of claim 5, wherein: the outer diameter of the spiral multi-ring part (6) is 1.05-3.05 mm, and the inner diameter is 1-3 mm.
7. The spatially curved helical polycyclic pulmonary vein ablation catheter of claim 6, wherein: the pipe of the spiral polycyclic part (6) is made of polyurethane, block polyether amide resin or nylon.
8. The spatially curved helical polycyclic pulmonary vein ablation catheter of claim 7, wherein: the inner of the tube of the spiral multi-ring part (6) is provided with a shaped steel wire (61), and the shaped steel wire (61) is in a shape of a disc-shaped concentric multi-ring or a ring in the same plane and is connected with at least two openings with opposite bending directions of the adjacent rings; the shaping wire (61) is a nickel-titanium wire, a copper-aluminum-nickel alloy wire, a copper-aluminum-zinc alloy wire, an iron-platinum alloy wire, an iron-palladium alloy wire, an iron-nickel-cobalt-titanium alloy wire or an iron-manganese-silicon alloy wire, the outer diameter is 0.1-0.7 mm, the diameter of an inner ring of the shaping wire (61) is 5-40 mm, and the outer diameter of an outermost ring is 10-70 mmm.
9. The spatially curved helical polycyclic pulmonary vein ablation catheter of claim 8, wherein: the outer diameter of the shaping wire (61) is 0.4-0.46 mm, the diameter of the inner ring of the shaping wire (61) is 10-20 mm, and the outer diameter of the outermost ring is 20-40 mm.
10. The spatially curved helical polycyclic pulmonary vein ablation catheter of claim 9, wherein: the spiral multi-ring part (6) is 2-5 circles in ring shape.