CN111991674B - Ablation device and method for fat-thickness obstructive cardiomyopathy - Google Patents
Ablation device and method for fat-thickness obstructive cardiomyopathy Download PDFInfo
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- CN111991674B CN111991674B CN202011028357.2A CN202011028357A CN111991674B CN 111991674 B CN111991674 B CN 111991674B CN 202011028357 A CN202011028357 A CN 202011028357A CN 111991674 B CN111991674 B CN 111991674B
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M25/0084—Catheter tip comprising a tool being one or more injection needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
Abstract
The invention relates to the field of medical equipment, in particular to a device and a method for ablation of hypertrophic obstructive cardiomyopathy. The hypertrophic obstructive cardiomyopathy ablation device of the invention comprises: an adjustable curved sheath, an inner sheath, a finger guide wire, and a mapping catheter; the outer diameters of the inner sheath tube and the mapping catheter are smaller than the inner diameter of the adjustable bent sheath tube; the front end of the finger guide wire is bent backwards; the front end of the mapping catheter is provided with an extendable ablation needle; the positioning system is electrically connected with the adjustable curved sheath tube and the mapping catheter, wherein the guiding guide wire can move to the right atrium along the femoral vein, the adjustable curved sheath tube and the inner sheath tube can move to the front end of the guiding guide wire along the guiding guide wire, the guiding guide wire and the guiding guide wire are moved out, the mapping catheter can enter the right ventricle along the adjustable curved sheath tube, and the ablation needle stretches into the ventricular septum thickening part after being bent and performs ablation operation. Through the arrangement mode, the mapping catheter can be sent to the preset position through the femoral vein, and the ablation needle stretches into the ventricular septum thickening part and performs ablation operation, so that ablation is realized.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a fat-thickness obstructive cardiomyopathy ablation device and a method thereof.
Background
Hypertrophic cardiomyopathy (febrile disease) is a hereditary cardiomyopathy characterized by ventricular septum and cardiac muscle asymmetry of the apex of the heart, with a global prevalence of about 200/10 ten thousand and a chinese prevalence of about 80/10 ten thousand. 70% of febrile disease patients have left ventricular outflow tract pressure difference (LVOTG) of more than or equal to 30 mmHg during rest or exercise, and belongs to obstructive hypertrophic cardiomyopathy (HOCM). The outflow obstruction seriously affects the heart ejection function, causes the symptoms of insufficient blood supply of the patient body, amaurosis, loss of consciousness and the like, and increases the sudden death risk.
In addition to drug therapy, the currently mainstream therapies for HOCM include: surgical ventricular septal resection, coronary ventricular septal chemical ablation, and percutaneous endocardial ventricular septal radio frequency ablation. Although the surgical interval excision has definite immediate effect, the operation is very traumatic.
Disclosure of Invention
The present invention aims to solve at least one of the technical problems existing in the prior art or related art.
Accordingly, it is an object of the present invention to provide an ablation device for hypertrophic obstructive cardiomyopathy.
It is another object of the present invention to provide a method of a fat-thickness obstructive cardiomyopathy ablation device.
In order to achieve the above object, a technical solution of a first aspect of the present invention provides an ablation device for fat-thickness obstructive cardiomyopathy, comprising: an adjustable curved sheath, an inner sheath, a finger guide wire, and a mapping catheter; the outer diameters of the inner sheath tube and the mapping catheter are smaller than the inner diameter of the adjustable bent sheath tube; the front end of the finger guide wire is bent backwards; the front end of the mapping catheter is provided with an extendable ablation needle; the positioning system is electrically connected with the adjustable curved sheath tube and the mapping catheter, wherein the guiding guide wire can move to the right atrium along the femoral vein, after the inner sheath tube is embedded into the adjustable curved sheath tube, the adjustable curved sheath tube and the inner sheath tube can move to the front end of the guiding guide wire along the guiding guide wire, then the guiding guide wire moves out of the inner sheath tube and the guiding guide wire, the mapping catheter can enter the right ventricle along the adjustable curved sheath tube, and after being bent, the mapping catheter is aligned to the thickest part of the heart, and the ablation needle extends into the ventricular septum thickening part and carries out ablation operation.
In this scheme, through setting up adjustable curved sheath pipe, interior sheath pipe, indicate guide wire and mapping pipe, can send mapping pipe to preset position through the femoral vein, follow the ablation needle and stretch out in the mapping pipe, the ablation needle stretches into the room interval fat part and carries out the ablation operation to realize the ablation, can reduce the wound simultaneously, alleviate patient's misery.
Specifically, the front end of the guiding wire is bent backwards, the front end of the guiding wire can be prevented from being scratched, meanwhile, the guiding wire is arranged, the adjustable curved sheath tube and the inner sheath tube can be conveyed to the right atrium, the right atrium is prevented from being punctured by the adjustable curved sheath tube due to the fact that the adjustable curved sheath tube is directly conveyed, and safety is improved. First, the finger guide wire is moved to the right atrium along the femoral vein, then the inner sheath tube is embedded into the adjustable curved sheath tube, the inner sheath tube is sleeved outside the guide wire, so that the adjustable curved sheath tube and the inner sheath tube move to the front end of the guide wire along the guide wire, then the inner sheath tube and the guide wire are removed, the mapping catheter can enter the right ventricle along the adjustable curved sheath tube and is aligned with the thickest part of the heart after being bent, the ablation needle extends out of the front end of the mapping catheter, and the ablation needle extends into the ventricular septum thickening part and carries out ablation operation (absolute ethyl alcohol is filled) so as to realize ablation.
In the moving process of the adjustable curved sheath tube and the mapping catheter, the positioning system positions the adjustable curved sheath tube and the mapping catheter according to signals of the adjustable curved sheath tube and the mapping catheter, so that accurate control is facilitated.
In the above technical solution, preferably, the adjustable curved sheath includes: the handle part is connected with a heparin saline water filling channel; the sheath tube is fixedly arranged at the front end of the handle part, the heparin saline filling channel is communicated with the interior of the sheath tube, a plurality of pairs of first annular electrodes are arranged on the sheath tube, each first annular electrode is electrically connected with the positioning system, and the front ends of the sheath tube and the inner sheath tube are bent; the device comprises a first bending steel wire and a first bending adjusting sliding block, wherein the first bending adjusting sliding block is arranged on a handle part in a sliding mode, the first bending steel wire is arranged in the pipe wall of a sheath pipe, two ends of the first bending steel wire are respectively fixed at the first bending adjusting sliding block and the front part of the sheath pipe, after a mapping catheter enters the sheath pipe, the first bending adjusting sliding block can drive the sheath pipe to bend towards a right ventricle, and the front end of the sheath pipe faces to a room space.
In any of the above-described aspects, preferably, the front end of the handle portion has a tapered portion through which the first bent wire passes along an axis of the tapered portion.
In any of the above technical solutions, preferably, a clamping portion is provided at a rear end of the inner sheath, and an outer diameter of the clamping portion is larger than an inner diameter of the sheath.
In any of the above aspects, preferably, the mapping catheter comprises: a handle portion; the catheter part is fixedly arranged at the front end of the handle part and is provided with a plurality of pairs of second annular electrodes, and each second annular electrode is electrically connected with the positioning system; the second bending steel wire and the second bending sliding block are arranged on the handle part in a sliding manner, the second bending steel wire is arranged in the guide pipe part, and two ends of the second bending steel wire are respectively fixed at the second bending sliding block and the front part of the guide pipe part; the device comprises a pushing steel wire and a depth adjusting slide block, wherein the depth adjusting slide block is arranged on a handle part in a sliding manner, and two ends of the pushing steel wire are respectively connected with an ablation needle and the depth adjusting slide block.
In any of the above solutions, preferably, the positioning system comprises: the electric signal processing device is connected with the first annular electrode and the second annular electrode; a plurality of pairs of electrode plates, wherein the electrode plates are adhered to the surface of a human body; the junction box is connected with the electrode plate; the positioning signal processing device is connected with the junction box and the electric signal processing device; and the controller is electrically connected with the positioning signal processing device and the electric signal processing device.
In any of the above technical solutions, preferably, the ablation needle is connected with a first electrode wire and a second electrode wire, and both the first electrode wire and the second electrode wire are connected with the electrical signal processing device.
In any of the foregoing solutions, preferably, the mapping catheter further comprises: and each magnetic induction coil is electrically connected with the electric signal processing device, and the three magnetic induction coils are perpendicular to each other.
In any of the above technical solutions, preferably, the rear end of the ablation needle is connected with an absolute ethyl alcohol injection channel, and after the ablation needle extends into the compartment thickening portion, the ablation needle injects absolute ethyl alcohol into the compartment thickening portion.
In any of the above embodiments, preferably, the rear end of the ablation needle is connected to and communicates with the absolute ethyl alcohol infusion channel through a hose.
The technical scheme of the second aspect of the invention provides a method for an ablation device for fat-thickness obstructive cardiomyopathy, which comprises the following steps: step S1, pushing the finger guide wire to move from the femoral vein to the right atrium; step S2, after the inner sheath tube is configured on the adjustable bent sheath tube, the adjustable bent sheath tube is sent to a right atrium along the finger guide wire, and the inner sheath tube and the finger guide wire are moved out; and step S3, feeding the catheter into a mapping catheter along the adjustable bent sheath, bending the mapping catheter to align the most-thick-spaced part of the chamber, and enabling an ablation needle to extend into the thick-spaced part of the chamber and perform ablation operation.
In the above technical solution, preferably, step S3 specifically includes: step S31, delivering the catheter into the mapping catheter along the adjustable curved sheath; s32, constructing a three-dimensional geometric surface of the right ventricle by using the mapping catheter, and recording characteristic potential; and step S33, the mapping catheter is bent to align with the most hypertrophied part of the compartment, and an ablation needle extends into the hypertrophied part of the compartment and performs an ablation operation.
Additional aspects and advantages of the invention will be set forth in part in the description which follows, or may be learned by practice of the invention.
Drawings
FIG. 1 is a schematic illustration of the structure of an adjustable bend sheath according to one embodiment of the present invention;
FIG. 2 is a schematic view of a portion of the structure of an adjustable bend sheath according to one embodiment of the present invention;
FIG. 3 is a schematic view of a portion of the structure of an adjustable bend sheath according to one embodiment of the present invention;
FIG. 4 is a schematic view of the structure of an inner sheath according to one embodiment of the present invention;
FIG. 5 is a schematic structural view of a mapping catheter according to one embodiment of the invention;
FIG. 6 is a schematic illustration of a portion of the structure of a mapping catheter according to one embodiment of the invention;
FIG. 7 is a schematic illustration of a portion of the structure of a mapping catheter according to one embodiment of the invention;
FIG. 8 is a cross-sectional view of a mapping catheter section structure according to one embodiment of the invention;
FIG. 9 is a partial schematic structural view of a mapping catheter according to one embodiment of the invention;
FIG. 10 is a schematic structural view of a hypertrophic obstructive cardiomyopathy ablation device according to one embodiment of the present invention;
FIG. 11 is a partial schematic structural view of a mapping catheter according to one embodiment of the invention;
FIG. 12 is a schematic structural view of a hypertrophic obstructive cardiomyopathy ablation device according to one embodiment of the present invention;
FIG. 13 is a state diagram of the operation of a hypertrophic obstructive cardiomyopathy ablation device according to one embodiment of the present invention;
FIG. 14 is a state diagram of the operation of a hypertrophic obstructive cardiomyopathy ablation device according to one embodiment of the present invention;
FIG. 15 is a state diagram of the operation of a hypertrophic obstructive cardiomyopathy ablation device according to one embodiment of the present invention;
FIG. 16 is a state diagram of the operation of a hypertrophic obstructive cardiomyopathy ablation device according to one embodiment of the present invention;
FIG. 17 is a state diagram of the operation of a hypertrophic obstructive cardiomyopathy ablation device according to one embodiment of the present invention;
fig. 18 is a state diagram of the operation of a hypertrophic obstructive cardiomyopathy ablation device according to one embodiment of the present invention.
Wherein, the correspondence between the reference numerals and the component names in fig. 1 to 18 is:
the device comprises a 10 adjustable bent sheath tube, a 11 handle part, a 12 sheath tube, a 13 first bent steel wire, a 14 first bending slide block, a 15 conical part, a 20 inner sheath tube, a 21 clamping part, a 30 finger guide wire, a 40 mapping catheter, a 41 handle part, a 42 catheter part, a 43 second bent steel wire, a 44 second bending module, a 45 pushing steel wire, a 46 depth adjusting slide block, a 47 ablation needle, a 50 first annular electrode, a 60 second annular electrode, a 70 electrode plate, an 80 electric signal processing device, a 90 junction box, a 100 positioning signal processing device, a 110 workstation, a 120 display, a 130 heparin saline water filling channel, a 140 absolute ethyl alcohol filling channel, a 150 first electrode wire, a 160 second electrode wire and a 170 magnetic induction coil.
Detailed Description
In order that the above-recited objects, features and advantages of the present invention will be more clearly understood, a more particular description of the invention will be rendered by reference to the appended drawings and appended detailed description. It should be noted that, in the case of no conflict, the embodiments of the present application and the features in the embodiments may be combined with each other.
In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, however, the present invention may be practiced in other ways than those described herein, and therefore the scope of the present invention is not limited to the specific embodiments disclosed below.
Some embodiments according to the present invention are described below with reference to fig. 1 to 18.
Examples
Referring to fig. 1-18, an embodiment of the present invention provides a fat-thickness obstructive cardiomyopathy ablation device comprising: an adjustable bend sheath 10, an inner sheath 20, a finger guide wire 30, and a mapping catheter 40; the outer diameter of both the inner sheath 20 and the mapping catheter 40 are smaller than the inner diameter of the adjustable curved sheath 10; the front end of the finger guide wire 30 is bent backward; the front end of the mapping catheter 40 is provided with an extendable ablation needle 47, and the rear end of the ablation needle 47 is communicated with an absolute ethyl alcohol perfusion channel; the positioning system is electrically connected with the adjustable curved sheath 10 and the mapping catheter 40, wherein the finger guide wire 30 can move to the right atrium along the femoral vein, after the inner sheath 20 is embedded into the adjustable curved sheath 10, the adjustable curved sheath 10 and the inner sheath 20 can move to the front end of the finger guide wire 30 along the finger guide wire 30, then the inner sheath 20 and the finger guide wire 30 are moved out, the mapping catheter 40 can enter the right ventricle along the adjustable curved sheath 10 and is aligned with the thickest part of the heart after being bent, and the ablation needle 47 stretches into the ventricular septum thickening part and is infused with absolute ethyl alcohol.
In this scheme, through setting up adjustable curved sheath pipe 10, interior sheath pipe 20, finger guide wire 30 and mapping catheter 40, can send mapping catheter 40 to preset position through the femoral vein, follow the ablation needle 47 and stretch out from mapping catheter 40 in afterwards, the ablation needle 47 stretches into the room interval fat part and fills absolute ethyl alcohol to realize chemical ablation, can reduce the wound simultaneously, alleviate patient's misery.
Specifically, the front end of the finger guide wire 30 is bent backward, thereby preventing the finger guide wire 30 from being scratched, and simultaneously, by arranging the finger guide wire 30, the adjustable curved sheath 10 and the inner sheath 20 can be delivered to the right atrium, thereby preventing the right atrium from being punctured by the adjustable curved sheath 10 due to the direct delivery of the curved sheath 10, and improving the safety. First, the guide wire 30 is moved along the femoral vein to the right atrium, then the inner sheath 20 is inserted into the adjustable curved sheath 10, the inner sheath 20 is sleeved outside the guide wire 30, so that the adjustable curved sheath 10 and the inner sheath 20 move along the guide wire 30 to the front end of the guide wire 30, then the inner sheath 20 and the guide wire 30 are removed, the mapping catheter 40 can enter the right ventricle along the adjustable curved sheath 10 and be aligned with the thickest part of the heart after being curved, the ablation needle 47 extends from the front end of the mapping catheter 40, and the ablation needle 47 extends into the ventricular septum thickening and is infused with absolute ethyl alcohol, so that chemical ablation is achieved.
It should also be noted that during movement of the adjustable curved sheath 10 and the mapping catheter 20, the positioning system positions the adjustable curved sheath 10 and the mapping catheter 20 according to the signals of the adjustable curved sheath 10 and the mapping catheter 20, so as to facilitate accurate control.
In the above embodiment, the adjustable bend sheath 10 preferably includes: a handle part 11, wherein a heparin saline filling channel 140 is connected to the handle part 11; and a sheath 12 fixedly arranged at the front end of the handle 11, wherein the heparin saline filling channel 140 is communicated with the interior of the sheath 12, a plurality of pairs of first annular electrodes 50 are arranged on the sheath 12, each first annular electrode 50 is electrically connected with the positioning system, and the front ends of the sheath 12 and the inner sheath 20 are bent; the first bending steel wire 13 and the first bending slide block 14, the first bending slide block 14 is slidably arranged on the handle 11, the first bending steel wire 13 is arranged in the tube wall of the sheath tube 12, and two ends of the first bending steel wire 13 are respectively fixed at the first bending slide block 14 and the front part of the sheath tube 12, wherein after the mapping catheter 40 enters the sheath tube 12, the first bending slide block 14 can drive the sheath tube 12 to bend towards the right ventricle, and the front end of the sheath tube 12 faces the ventricular septum.
Specifically, the wall of the sheath tube 12 is divided into an inner layer and an outer layer, and the wall is made of a polyethylene material with certain flexibility, and the first bending steel wire 13 is positioned in a gap between the two layers.
In this scheme, by sliding the first bending adjustment slider 14, the first bending steel wire 13 can drive the sheath tube 12 to bend, so as to achieve bending of the bending adjustable sheath tube 10.
At the same time, the infusion of heparin saline through the heparin saline infusion channel 140 prevents thrombosis.
Meanwhile, the first ring electrodes 50 are plural pairs, and when the sheath 12 is bent, the current intensity of the first ring electrodes 50 is changed to calculate the bending position of the adjustable bent sheath 10.
In any of the above embodiments, it is preferable that the front end of the handle portion 11 has a tapered portion 15, and the first bent wire 13 passes through the tapered portion 15 along the axis of the tapered portion 15.
In this scheme, toper portion 15 can play the marking effect, and when first bending wire 13 crooked, can know the angle of buckling of first bending wire 13 with reference to toper portion 15, and then be convenient for control sheath 12's angle of buckling prevents that sheath 12 from excessively buckling and damaging heart intracavity structure.
In any of the above embodiments, preferably, the rear end of the inner sheath 20 is provided with a clamping portion 21, and the outer diameter of the clamping portion 21 is larger than the inner diameter of the adjustable curved sheath 10.
In this embodiment, the rear end of the inner sheath 20 is provided with a clamping portion 21, and the outer diameter of the clamping portion 21 is larger than the inner diameter of the sheath 12, so as to limit the inner sheath 20 and control the sliding distance of the inner sheath 20 in the adjustable bent sheath 10.
In any of the above embodiments, preferably, the mapping catheter 40 comprises: a handle portion 41; and a duct portion 42 fixedly provided at the front end of the handle portion 41, the duct portion 42 being provided with a plurality of pairs of second ring electrodes 60, each second ring electrode 60 being electrically connected to the positioning system; the second bending steel wire 43 and the second bending slide block 44, the second bending slide block 44 is slidably arranged on the handle part 41, the second bending steel wire 43 is arranged in the conduit part 42, and two ends of the second bending steel wire 43 are respectively fixed at the front parts of the second bending slide block 44 and the conduit part 42; the pushing wire 45 and the depth adjustment slider 46, the depth adjustment slider 46 is slidably disposed on the handle portion 41, and both ends of the pushing wire 45 are connected to the ablation needle 47 and the depth adjustment slider 46, respectively.
Specifically, the pipe wall of the pipe portion 42 is divided into an inner layer and an outer layer, and the pipe wall is made of a polyethylene material with a certain flexibility, and the second bending steel wire 43 is located in a gap between the two layers.
In this embodiment, by sliding the second bending adjustment slider 44, the second bending wire 43 can drive the catheter portion 42 to bend, so as to bend the mapping catheter 40.
Meanwhile, by sliding the depth adjustment slider 46, the extension of the ablation needle 47 can be controlled, and thus the extension length of the ablation needle 47 can be controlled.
It should be further noted that the second ring electrodes 60 are plural pairs, and when the catheter portion 42 is bent, the current intensity of the second ring electrodes 60 is changed to calculate the bending position of the mapping catheter 40.
It should be noted that, after the mapping catheter 40 enters the sheath 12, the first bending slider 14 can drive the sheath 12 to bend towards the right ventricle, and make the front end of the sheath 12 face the ventricular septum, so that the catheter portion 42 can extend to the thickest ventricular septum, and the bending requirement of the catheter portion 42 can be reduced, so that the catheter portion 42 can be easily bent to the required radian.
In a preferred embodiment, the length of the ablation needle 47 that can extend beyond the distal end of the catheter section 42 is 7-9mm. The angle between the needle tip plane and the long axis of the needle is 30 degrees, and the diameter is 2.5-3.5mm. Two side holes are symmetrically distributed at the tip end of the ablation needle 47 to facilitate the injection of absolute ethyl alcohol, so that the scope approximately keeps an ellipsoid shape with the tip as the center of a circle.
In an alternative embodiment, there are four side holes symmetrically distributed at the tip end of the ablation needle 47.
Although various specific examples of the number of side holes are enumerated above, the scope of the present invention is not limited to these specific structures, and those skilled in the art can set the number of side holes as needed, provided that convenient injection of absolute ethanol can be achieved.
In any of the above embodiments, preferably, the positioning system comprises: an electric signal processing device 80 connected to the first ring electrode 50 and the second ring electrode 60; a plurality of pairs of electrode plates 70, the electrode plates 70 being attached to the surface of the human body; a junction box 90 connected to the electrode sheet 70; a positioning signal processing device 100 connected to the junction box 90 and the electric signal processing device 80; and a controller electrically connected to the positioning signal processing device 100 and the electric signal processing device 80.
In this embodiment, the electrical signal processing device 80 is configured to filter the interference in the cardiac electrical signal, amplify the cardiac electrical signal, and obtain the current intensity of the first ring electrode 50 and the second ring electrode 60, and output the current intensity to the controller.
In any of the above embodiments, the ablation needle 47 is preferably connected with a first wire electrode 150 and a second wire electrode 160, and the first wire electrode 150 and the second wire electrode 160 are connected with the electrical signal processing device 80.
The positioning signal processing device 100 is connected to 6 electrode pads 70 that emit and receive high-frequency currents in an x, y, z three-axis stereotactic coordinate system, and the positioning signal processing device 100 further has a device for analyzing and processing positioning data. The 6 electrode pads 70 are attached to the anterior chest and shoulder, the anterior chest and subxiphoid, the posterior back of the back neck and near the posterior superior iliac crest, respectively. The 6 electrode plates 70 are divided into three pairs, with the currents emitted by the three pairs of electrode plates 70 being orthogonal and perpendicular, defining three substantially perpendicular reference axes, referred to herein as the x-axis, the y-axis, and the z-axis. In the signal transmission circuit of each pair of electrode pads 70, one of the pair of electrode pads 70 serves as a signal transmitting side and the other serves as a signal receiving side. The signal intensity of the transmitting side is 100%, the signal intensity of the receiving side is 0, and the current intensity between the pair of electrode plates 70 is linearly attenuated with the transmission distance. The electrical signal processing can transmit the information of the high-frequency current intensity in the different directions of x, y and z recorded by the catheter portion 42 and the inner electrode of the sheath tube 12 to the positioning signal processing device 100, the controller receives the information of the high-frequency current intensity of the positioning signal processing device 100, and can calculate the positions of the first ring electrode 50 and the second ring electrode 60 in the x, y and z three-axis in-vitro coordinate system according to the high-frequency current intensity, and further can determine the space coordinates of the first ring electrode 50 and the second ring electrode 60, and can determine the positions of the catheter portion 42 and the sheath tube 12 according to the space coordinates of the first ring electrode 50 and the second ring electrode 60; based on the positional relationship between the plurality of first ring electrodes 50, the substantially bent state of the sheath 12 can be determined; by the same token, the substantially bent state of the catheter section 42 can be determined based on the positional relationship between the plurality of second ring electrodes 60, and the sheath 12 and the shaft of the catheter section 42 can be displayed in the positioning system.
The controller calculates and integrates the information of the electric signal processing device 80 and the positioning signal processing device 100, the electrode of the second ring electrode 60 at the front end of the catheter part 42 is contacted with a plurality of points of the heart chamber, the coordinates of the points of the inner wall of the heart chamber can be recorded, the points are connected through a curved surface to obtain the three-dimensional configuration of the mapping heart chamber, meanwhile, the distribution area of the electrode in the sheath 12 can also be transmitted to the workstation 110, and the tube body of the sheath 12 can also be displayed in the system. In addition, when the position of the catheter portion 42 is fixed, the first electrode wire 150 and the second electrode wire 160 can form electrode pairs with the second ring electrode 60, respectively, and the proximal electrode position of the ablation needle 47 is also deviated from the second ring electrode 60 on the catheter portion 42 during the movement of the ablation needle 47, so that the position of the ablation needle 47 can also be expressed. By taking the spot, the needle insertion position and the needle insertion depth of the ablation needle 47 can be determined.
In this embodiment, the controller refers to a controller of the workstation 110.
Referring to fig. 10, a display device is also included, which is electrically coupled to the working machine for displaying the position of the mapping catheter 40 and the adjustable curved sheath 10 for convenient manipulation by the physician.
Specifically, in a preferred embodiment, the sheath 12 has a total length of 115-120cm, wherein the total length of the sheath 12 that can extend into the body is 82-85cm. The sheath 12 has a diameter of 27-30mm, the sheath 12 is hollow, and the hollow tube has a diameter of 25-27mm, and is a passage into and out of the catheter section 42, which communicates with the handle tip.
The ring electrode is located in an inner nesting layer of the sheath 12 that does not open at the distal end of the catheter section 42. Each electrode is connected with a metal wire, the electrodes are mutually insulated, the metal wire material can be selected from platinum, copper, aluminum, silver and other materials, and the metal wire is connected with the tail wire through a welding spot. The tail wire is further connected to an electrical signal processing device 80 through the underside of the handle.
In a preferred embodiment, the conduit portion 42 is a polyethylene material having a certain flexibility. The mapping catheter 40 has a total length of about 125-130cm, and the catheter portion 42 that extends into the body is about 115-120cm in length and about 25-27mm in diameter. The catheter portion 42 has 4 mapping electrodes at its end, the material of which is the same as that of the inner electrode of the sheath 12, each electrode is connected to a metal wire, the electrodes are mutually insulated, the metal wire material can be selected from platinum, copper, aluminum, silver, etc., and the metal wire is connected to the tail wire through a welding point.
The tail wire is further connected to an electrical signal processing device 80 through the underside of the handle. The electrodes at the distal end of the catheter section 42 are mapping electrodes that primarily function as mapping units and imaging in a three-dimensional positioning system, wherein four electrodes form two electrode pairs that can simultaneously display monopolar and bipolar potentials.
In this scheme, the first electrode wire 150 and the second electrode wire 160 can form an electrode pair with the second ring electrode 60 (i.e. the ring electrode), so that the extending length of the ablation needle 47 can be marked, and the extending length of the ablation needle 47 can be accurately controlled, so that the ablation effect is convenient to ensure. Meanwhile, the electrode pair formed by the ablation needle and the second annular electrode can display potential information in the muscle.
The followingThe specific operation of the hypertrophic obstructive cardiomyopathy ablation device of the present embodiment is described with reference to fig. 1 to 10 and fig. 13 to 18. In this embodiment, referring to fig. 10, in the whole structure of the ablation device for hypertrophic obstructive cardiomyopathy, first, after the visual adjustable curved sheath 10 and the inner sheath 20 are assembled in vitro, the guide wire 30 is delivered into the body to the right atrium, and the guide wire 30 is delivered into the sheath 12 and the inner sheath 20 to be combined to the end of the guide wire 30, but the J-shaped head end of the front end of the guide wire 30 is kept outside the sheath 12 (refer to fig. 13).
After the inside of the sheath tube 12 is drained and exhausted, the guide wire and the inner sheath tube 20 are withdrawn and then fed into the mapping catheter 40 along the sheath tube 12 until the tip of the mapping catheter section 42 slightly protrudes from the tip of the sheath tube 12 (see fig. 14).
The first bending slider 14 of the handle 11 of the bendable sheath 10 is slid to bend the distal end of the sheath 12 to the vicinity of the tricuspid annulus, and the mapping catheter 40 is passively bent along with the distal end of the sheath 12 (see fig. 15).
The handle 11 is fixed, and the catheter 42 is fed into the right ventricle along the sheath 12, and at this time, the endocardial surface of the right ventricle is spotted by bending, rotating, advancing and retreating, a three-dimensional geometric surface of the right ventricle is constructed, and certain characteristic potentials (the shi beam potential and the right beam branch potential) are recorded (see fig. 16).
Subsequently, the catheter section 42 is bent and rotated so that the distal end of the catheter section 42 is vertically abutted against the most dense ventricular septum, and a non-bundle branch potential deformation is selected as an initial puncture site (see fig. 17).
After the puncture site is selected, the sheath 12 and the catheter portion 42 are fixed, the depth adjustment slider 46 of the handle portion 41 is slid, the ablation needle 47 is extended from the distal end of the catheter portion 42 into the space, and the needle insertion is stopped when the tip reaches the center of the space, and the absolute ethyl alcohol is injected along the absolute ethyl alcohol injection channel on the handle portion 41, thereby completing chemical ablation of the space (see fig. 18).
Wherein the ablation needle 47 is connected to the absolute ethyl alcohol infusion channel by a hose so as to remain in communication with the absolute ethyl alcohol infusion channel when the ablation needle 47 is extended.
In this case, the distal end of the catheter section 42 is not bent because of the presence of the puncture needle. The length of the bent section of the sheath 12 is thus longer than the catheter portion 42, and the length of the bent section of the catheter portion 42 is also longer than the length of the puncture needle. In order to ensure that the catheter portion 42 can smoothly enter the right ventricle, the catheter portion 42 needs to be fed into the sheath 12, then the sheath 12 is bent, the initial feeding direction of the catheter portion 42 is determined, and the catheter portion 42 is fed into the ventricle.
In an alternative embodiment, the positioning system is an EnSite NavXTM navigation and visualization system from St.Jude Medical, atrial Fibrillation Division.
Although various specific examples of positioning systems are listed above, one skilled in the art may select other positioning systems as desired, provided that positioning is enabled.
Examples
Referring to fig. 11 and 12, the difference between this embodiment and embodiment 1 is that three magnetic induction coils 170 are further provided in the catheter section 42, each of the magnetic induction coils 170 is electrically connected to the electric signal processing device 80, and the three magnetic induction coils 170 are perpendicular to each other.
In this embodiment, referring to fig. 11, three copper magnetic induction coils 170 perpendicular to each other are provided at the tip of the catheter section 42, and the magnetic induction coils are connected to an electric signal processing device through metal wires as current receptors. Under the patient there is a magnetic field generator device comprising three magnetic field generators generating magnetic fields of different frequencies, the catheter section 42 generating unique current signals in the x, y, z axes when moving within the magnetic fields, producing spatial coordinates.
The structural diagram of the hypertrophic obstructive cardiomyopathy ablating device of the present embodiment is shown in fig. 12.
The positioning signal processing device 100 is connected to the 6 electrode pads 70, and further has a device for analyzing and processing positioning data. The 6 electrode plates 70 are respectively attached to the left and right chest portions, the lower part of the xiphoid process of the chest, the back of the back neck and the inside of the left and right back magnetic fields. The 6 electrode pads 70 are paired one by one and the three pairs of electrode pads are used to measure induced currents in the x, y, z axes, respectively.
After entering the magnetic field, the catheter section 42 can be positioned by being three magnetic induction coils 170, i.e., determining the specific position of the catheter section in the magnetic field. Meanwhile, the second ring electrode 60 corresponding to the position of the magnetic induction coil 170 cuts the magnetic induction line to generate induction current, and the 6 electrode patches can also receive and record current changes at the same time to obtain a set of current coefficient ratios (a 1, a2, a3, a4, a5 and a 6), when the position of the conduit part 42 changes, the current generated by the second ring electrode 60 correspondingly changes, so that the current coefficient ratio also changes, and thus, a one-to-one correspondence relation between a specific position in the magnetic field space and the current coefficient ratio can be obtained.
The catheter section 42 will thus create coordinate data within a certain space when moving within the magnetic field.
Specifically, when the electrode in the sheath 12 with the first ring electrode 50 enters the magnetic field, the first ring electrode 50 cuts the magnetic induction line, and corresponding current coefficient ratios (b 1, b2, b3, b4, b5, b 6) are obtained through the 6 electrode patches, and when the current coefficient ratios are compared and consistent with the current coefficient ratios in the system, the spatial position information of the sheath 12 can be calculated and displayed in the system.
In this embodiment, through the external magnetic field generator device, on the one hand, interference of the environment in the body can be avoided, and meanwhile, a magnetic field region which is approximately linear can be manufactured, so that positioning accuracy is improved.
When the present solution is applied for ablation, the catheter portion 42 needs to be moved and reconstructed in the right atrium and other necessary areas, that is, the area where the sheath 12 may appear, to create spatial coordinate data, and then the sheath 12 and the catheter portion 42 are extended into the right ventricle to complete the ablation reconstruction procedure of embodiment 1.
In an alternative embodiment, the positioning system is a CARTO navigation and positioning system from Biosense Webster.
In another alternative embodiment, the positioning system is the AURORA system of Northern Digital corporation.
Although various specific examples of positioning systems are listed above, one skilled in the art may select other positioning systems as desired, provided that positioning is enabled.
Examples
The present embodiment differs from embodiment 1 or embodiment 2 in that in the present embodiment, the ablation needle is connected to an external ablation energy generator, and corresponding ablation energy is provided to complete ablation. Ablation energy generators include, but are not limited to, radio frequency ablators, pulsed electric field ablators, and the like.
Examples
The present embodiments provide a method (method of use) of a fat-thickness obstructive cardiomyopathy ablation device, comprising: step S1, pushing the finger guide wire 30 to move from the femoral vein to the right atrium; step S2, after the inner sheath 20 is configured on the adjustable curved sheath 10, the adjustable curved sheath 10 is sent to the right atrium along the finger guide wire 30, and the inner sheath 20 and the finger guide wire 30 are removed; step S3, the mapping catheter 40 is sent along the adjustable bent sheath 10, the mapping catheter 40 is bent to align with the most pachymally-spaced part of the compartment, and the ablation needle 47 extends into the pachymally-spaced part and performs an ablation operation.
In this aspect, a method of a hypertrophic obstructive cardiomyopathy ablation device comprises: step S1, pushing the finger guide wire 30 to move from the femoral vein to the right atrium; step S2, after the inner sheath 20 is configured on the adjustable curved sheath 10, the adjustable curved sheath 10 is sent to the right atrium along the finger guide wire 30, and the inner sheath 20 and the finger guide wire 30 are removed, so that the right atrium is prevented from being punctured by the adjustable curved sheath 1010 due to direct sending of the curved sheath 10, and the safety is improved; in step S3, the mapping catheter 40 is fed along the adjustable curved sheath 10, and the mapping catheter 40 is bent to align with the most-thickening portion of the ventricular septum, and the ablation needle 47 is inserted into the thickening portion of the ventricular septum and performs an ablation operation (e.g., infusion of absolute ethyl alcohol) to achieve chemical ablation.
In the above embodiment, preferably, step S3 specifically includes: step S31, delivering the catheter 40 along the adjustable curved sheath 10; step S32, constructing a three-dimensional geometric surface of the right ventricle by using the mapping catheter 40, and recording characteristic potential; in step S33, the mapping catheter 40 is bent to align with the most ventricular septum portion, and the ablation needle 47 is extended into the ventricular septum portion and an ablation procedure is performed.
In this scheme, step S3 specifically includes: step S31, delivering the catheter 40 along the adjustable curved sheath 10; in step S32, a three-dimensional geometric surface of the right ventricle is constructed using the mapping catheter 40, and the characteristic potential is recorded. At this time, the doctor is convenient to control the bending angle of the mapping catheter 40, and safety is improved. Meanwhile, by constructing a three-dimensional geometric surface of the right ventricle, a doctor can conveniently confirm the most hypertrophied ventricular septum. In step S33, the mapping catheter 40 is bent to align with the most-pachymally-spaced portion, and the ablation needle 47 is extended into the pachymally-spaced portion and subjected to an ablation operation (e.g., infusion of absolute ethyl alcohol) to achieve chemical ablation.
In an alternative embodiment, the ablation operation is performed by connecting the ablation needle to an external ablation energy generator, and providing the corresponding ablation energy to complete the ablation.
In the present invention, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance; the term "plurality" means two or more, unless expressly defined otherwise. The terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; "coupled" may be directly coupled or indirectly coupled through intermediaries. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the description of the present invention, it should be understood that the directions or positional relationships indicated by the terms "upper", "lower", "left", "right", "front", "rear", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or units referred to must have a specific direction, be constructed and operated in a specific direction, and thus should not be construed as limiting the present invention.
In the description of the present specification, the terms "one embodiment," "some embodiments," "particular embodiments," and the like, mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (8)
1. An ablation device for fat-thickness obstructive cardiomyopathy, which is characterized in that,
comprising the following steps:
an adjustable curved sheath, an inner sheath, a finger guide wire, and a mapping catheter;
the outer diameters of the inner sheath tube and the mapping catheter are smaller than the inner diameter of the adjustable bent sheath tube;
the front end of the guiding wire is bent backwards;
the front end of the mapping catheter is provided with an extendable ablation needle;
a positioning system electrically connected with the adjustable curved sheath tube and the mapping catheter,
wherein the guiding guide wire can move to the right atrium along the femoral vein, after the inner sheath tube is embedded into the adjustable curved sheath tube, the adjustable curved sheath tube and the inner sheath tube can move to the front end of the guiding guide wire along the guiding guide wire, then the guiding guide wire and the inner sheath tube are removed, the mapping catheter can enter the right ventricle along the adjustable curved sheath tube and is aligned to the most thick part of the ventricular septum after being curved, the ablation needle stretches into the thick part of the ventricular septum and carries out ablation operation,
wherein the mapping catheter comprises a catheter portion, and the length of the ablation needle which can extend out of the tail end of the catheter portion is 7-9mm.
2. The hypertrophic obstructive cardiomyopathy ablation device according to claim 1,
the adjustable bend sheath includes:
the handle part is connected with a heparin saline filling channel; and
the sheath pipe is fixedly arranged at the front end of the handle part, the heparin saline filling channel is communicated with the interior of the sheath pipe, a plurality of pairs of first annular electrodes are arranged on the sheath pipe, each first annular electrode is electrically connected with the positioning system, and the front ends of the sheath pipe and the inner sheath pipe are bent;
the first bending steel wire and the first bending sliding block are arranged on the handle part in a sliding way, the first bending steel wire is arranged in the pipe wall of the sheath pipe, two ends of the first bending steel wire are respectively fixed at the first bending sliding block and the front part of the sheath pipe,
after the mapping catheter enters the sheath, the first bending slider can drive the sheath to bend towards the right ventricle, and the front end of the sheath faces the ventricular septum.
3. The hypertrophic obstructive cardiomyopathy ablation device according to claim 2,
the front end of the handle portion has a tapered portion through which the first bent wire passes along an axis of the tapered portion.
4. The hypertrophic obstructive cardiomyopathy ablation device according to claim 2 or 3,
the rear end of the inner sheath tube is provided with a clamping part, and the outer diameter of the clamping part is larger than the inner diameter of the adjustable bent sheath tube.
5. The hypertrophic obstructive cardiomyopathy ablation device according to claim 2 or 3,
the mapping catheter includes:
a handle portion; and
the catheter part is fixedly arranged at the front end of the handle part and is provided with a plurality of pairs of second annular electrodes, and each second annular electrode is electrically connected with the positioning system;
the second bending steel wire and the second bending sliding block are arranged on the handle part in a sliding manner, the second bending steel wire is arranged in the guide pipe part, and two ends of the second bending steel wire are respectively fixed at the second bending sliding block and the front part of the guide pipe part;
the device comprises a pushing steel wire and a depth adjusting slide block, wherein the depth adjusting slide block is arranged on the handle part in a sliding manner, and two ends of the pushing steel wire are respectively connected with the ablation needle and the depth adjusting slide block.
6. The hypertrophic obstructive cardiomyopathy ablation device according to claim 5,
the positioning system comprises:
the electric signal processing device is electrically connected with the first annular electrode and the second annular electrode;
the electrode plates are adhered to the surface of a human body;
the junction box is connected with the electrode plate;
the positioning signal processing device is connected with the junction box and the electric signal processing device;
and the controller is electrically connected with the positioning signal processing device and the electric signal processing device.
7. The hypertrophic obstructive cardiomyopathy ablation device according to claim 6,
the ablation needle is connected with a first electrode wire and a second electrode wire, and the first electrode wire and the second electrode wire are connected with the electric signal processing device.
8. The hypertrophic obstructive cardiomyopathy ablation device according to claim 6,
the mapping catheter further comprises:
and the three magnetic induction coils are electrically connected with the electric signal processing device, and are perpendicular to each other.
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| WO2023125927A1 (en) * | 2021-12-31 | 2023-07-06 | 杭州诺沁医疗器械有限公司 | Ablation needle, ablation device and ablation system for myocardial ablation |
| WO2023123472A1 (en) * | 2021-12-31 | 2023-07-06 | 杭州诺沁医疗器械有限公司 | Adjustable guide sheath, ablation device, ablation system and myocardial ablation method |
| CN117653322A (en) * | 2022-08-31 | 2024-03-08 | 杭州诺沁医疗器械有限公司 | Guide assembly for achieving stable needle, ablation device and ablation system |
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