CN115844519B - Catheter assembly with electrode capable of entering tissue - Google Patents

Catheter assembly with electrode capable of entering tissue Download PDF

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Publication number
CN115844519B
CN115844519B CN202211569423.6A CN202211569423A CN115844519B CN 115844519 B CN115844519 B CN 115844519B CN 202211569423 A CN202211569423 A CN 202211569423A CN 115844519 B CN115844519 B CN 115844519B
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inner tube
electrode
outer tube
tube
ring electrode
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CN115844519A (en
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尤超
陈斌
邹波
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Sichuan Jinjiang Electronic Medical Device Technology Co ltd
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Sichuan Jinjiang Electronic Medical Device Technology Co ltd
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Abstract

The invention discloses a catheter assembly with an electrode capable of entering into tissues, which comprises a catheter handle, an inner tube and an outer tube, wherein the outer tube is sleeved outside the inner tube, the inner tube can slide along the outer tube, a spiral electrode is arranged at the head of the inner tube and is used for rotating to enter into the tissues and collecting electrophysiological signals, the catheter handle is provided with a stretch bending mechanism and a rotating mechanism, the stretch bending mechanism is provided with a traction wire and can bend an adjustable bending section of the outer tube, and the rotating mechanism is provided with a gear set and can enable the inner tube to stretch out or retract in a rotating mode. The invention adopts the design of the inner tube and the outer tube, the head end of the inner tube is retracted to the outer tube and can be used for three-dimensional modeling, the form and the position of the catheter are displayed in the three-dimensional model in real time, the risk of screwing the inner tube to be too deep is reduced, and the exposure time of operators and patients in rays is reduced. According to the invention, the inner tube and the outer tube realize the rotating advancing or retreating of the inner tube in the same set of catheter handles, and the bending type adjustable function of the front end of the outer tube greatly simplifies the complexity of operation control and improves the operation efficiency.

Description

Catheter assembly with electrode capable of entering tissue
Technical Field
The invention relates to the field of catheters, in particular to a catheter assembly with an electrode capable of entering into tissues.
Background
Hypertrophic cardiomyopathy (hypertrophic cardiomyopathy) is a hereditary cardiomyopathy and the ventricles of patients are characterized by an asymmetric hypertrophy of the ventricles. The disease is one of the most leading causes of sudden death in teenagers. In hypertrophic cardiomyopathy, approximately 75% of patients have left ventricular outflow tract obstruction due to hypertrophy of left ventricular outflow tract spacers. When the pressure difference before and after obstruction is more than or equal to 30mmHg at rest or more than or equal to 50mmHg at exercise, the ventricular volume reduction operation can be considered for treatment.
At present, the ventricular volume reduction operation mainly adopts two modes of surgical ventricular resection or ventricular alcohol ablation. The surgical department interval excision is mainly suitable for young patients, has the defects of large wounds and long recovery period, and has high risk. The interventricular alcohol ablation is suitable for patients with advanced disease and serious complications, but the alcohol ablation range is uncertain, the opportunity for re-operation is large, and the interventricular alcohol ablation is only used as a supplement of the surgical interventricular volume reduction operation.
With the advancement of radio frequency ablation, and the proliferation of cardiac three-dimensional mapping systems. Radio frequency ablation in three dimensions has been widely used in cardiology. The three-dimensional mapping technology can accurately reconstruct an anatomical model of a ventricle, thereby identifying the myocardial hypertrophy obstruction part and carrying out the ventricular volume reduction operation. However, the blood flow is large at the inter-ventricular position, the endocardium is smooth, the conventional radio frequency ablation catheter technology is difficult to reach and form a stable and enough-depth radio frequency ablation point at the inter-ventricular position, and the radio frequency ablation can not be directly carried out in the tissue.
And the traditional radio frequency ablation operation adopts thermal effect to ablate tissues, so that the selective ablation of myocardial tissues can not be realized. The existing alcohol ablation and radio frequency ablation can not accurately position the focus, a large amount of rays are needed for auxiliary positioning in the operation treatment, and a large ray risk is brought to patients and operators.
Disclosure of Invention
The invention aims at: in response to the problems of the prior art, a catheter assembly is provided in which an electrode is accessible within tissue.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
the catheter assembly with the electrode capable of entering the tissue comprises a catheter handle, an inner tube and an outer tube, wherein the outer tube is sleeved outside the inner tube, the inner tube can slide along the outer tube, the head of the inner tube is provided with a spiral electrode which is used for rotating into the tissue and collecting electrophysiological signals,
the catheter handle is provided with a stretch bending mechanism and a rotating mechanism, the stretch bending mechanism is provided with a traction wire which can enable the adjustable bending section of the outer tube to bend, and the rotating mechanism is provided with a gear set which can enable the inner tube to extend or retract in a rotating mode.
The head end of the inner tube comprises the spiral electrode, and the inner tube spiral electrode can be driven to rotate to enter myocardial tissue by rotating the knob of the catheter handle and release ablation energy in the tissue, so that the problem of insufficient ablation depth at present is solved. The invention adopts the design of the inner tube and the outer tube, the head end of the inner tube is retracted to the outer tube and can be used for three-dimensional modeling, the form and the position of the catheter are displayed in the three-dimensional model in real time, the relative positions of the head ends of the inner tube and the outer tube are reduced, the risk of screwing the inner tube too deeply is reduced, and the exposure time of operators and patients in rays is reduced. According to the invention, the inner tube and the outer tube realize the rotating advancing or retreating of the inner tube in the same set of catheter handles, and the bending type adjustable function of the front end of the outer tube greatly simplifies the complexity of operation control and improves the operation efficiency.
As a preferable scheme of the invention, the stretch bending mechanism comprises a fixed block and a traction sliding block, the outer tube is fixedly connected with the fixed block, one end of the traction wire is fixed at the head end of the outer tube, the other end of the traction wire is fixed at the traction sliding block, the fixed block is fixed on the catheter handle, the fixed block is slidably connected with a push rod sliding block, the push rod sliding block is provided with a push button, and the push rod sliding block is connected with the traction sliding block through a gear in a meshed manner.
As a preferable mode of the invention, the rotating mechanism comprises a conical ring, an adjusting screw, a gear set, a driven gear and a knob, wherein the inner pipe penetrates through the conical ring and the adjusting screw and is fixed with the driven gear, the knob is arranged on the outer pipe, and the knob is meshed with the driven gear through the gear set.
As a preferable scheme of the invention, a first ring electrode and a second ring electrode are arranged at intervals at the head end of the inner tube, the first ring electrode and the second ring electrode are positioned at the rear end of the spiral electrode, a first positioning sensor is arranged between the first ring electrode and the second ring electrode, and the first positioning sensor is embedded in the tail end tube of the inner tube.
As a preferable mode of the invention, the lengths of the first ring electrode and the second ring electrode are 1-5 mm, and the distance between the first ring electrode and the second ring electrode is 1-3 mm.
As a preferable scheme of the invention, an inner cavity at the rear end of the catheter handle is provided with a placing space, the placing space is used for placing an inner tube electrode wire, and the inner tube electrode wire is connected with the spiral electrode, the first ring electrode and the second ring electrode.
As a preferable scheme of the invention, the head end of the outer tube is provided with an outer tube head electrode, a third ring electrode, a second positioning sensor and a third positioning sensor, wherein the third ring electrode is positioned at the rear end of the outer tube head electrode, and the second positioning sensor and the third positioning sensor are positioned at the rear end of the third ring electrode.
As a preferred embodiment of the present invention, the second positioning sensor and the third positioning sensor form a first distribution plane, the first distribution plane is parallel to the axis of the outer tube, and a certain included angle is formed between the second positioning sensor and the third positioning sensor. The setting is convenient for calculate the relative position of inner tube, outer tube, reduces the risk that the inner tube screw in is too dark.
As a preferable scheme of the invention, the top end of the outer tube head electrode is a plane, and the distance between the outer tube head electrode and the third ring electrode is 1 mm-5 mm.
As a preferable scheme of the invention, an outer pipeline is arranged in the outer pipeline, the outer pipeline is used for providing a passage for the inner pipeline or injecting liquid, and the outer pipeline is connected with a perfusion connecting pipe which has a perfusion function and is used for sealing the outer pipeline by adjusting tightness between the adjusting screw and the shell.
In summary, due to the adoption of the technical scheme, the beneficial effects of the invention are as follows:
1. the head end of the inner tube comprises the spiral electrode, and the inner tube spiral electrode can be driven to rotate to enter myocardial tissue by rotating the knob of the catheter handle and release ablation energy in the tissue, so that the problem of insufficient ablation depth at present is solved. In order to achieve this function, the tip spiral electrode may take a variety of design shapes.
2. The invention adopts the design of the inner tube and the outer tube, the inner tube and the outer tube are both provided with the electrode and the positioning sensor, the head end of the inner tube is retracted to the outer tube and can be used for three-dimensional modeling, the form and the position of the catheter are displayed in the three-dimensional model in real time, the relative positions of the head ends of the inner tube and the outer tube reduce the risk of screwing the inner tube too deeply, and simultaneously reduce the exposure time of operators and patients in rays.
3. The inner tube and the outer tube realize the rotation advancing or retreating of the inner tube in the same set of catheter handles, the bending type adjustable function of the front end of the outer tube, and simultaneously have the perfusion function, so that the complexity of operation control is greatly reduced, and the operation efficiency is improved.
4. The inner cavity at the rear end of the catheter handle is provided with a space, the inner tube electrode lead has enough space allowance to rotate along with the inner tube without twisting and breaking, and the rotation stress is not conducted to the inner tube connector and the external cable connected with the inner tube connector along with the connecting wire, so that the condition that the connecting wire or the external cable is deformed due to the rotation of the inner tube and the stress drag is avoided, and the catheter is displaced.
5. The energy source used in the invention can select high-voltage pulse electric field energy, and has the advantages of high efficiency, small wound and few complications compared with the existing operation treatment mode.
Drawings
Fig. 1 is an overall block diagram of a catheter assembly.
Fig. 2 is a three-dimensional schematic view of a catheter handle.
Fig. 3 is a view showing the construction of the interior of the catheter handle.
Fig. 4 is a structural diagram of the stretch bending mechanism.
Fig. 5 is a drawing of a second structure of the stretch bending mechanism.
Fig. 6 is a drawing of a third structure of the stretch bending mechanism.
Fig. 7 is a structural view of the rotation mechanism.
Fig. 8 is a second structural view of the rotating mechanism.
Fig. 9 is a third structural view of the rotating mechanism.
Fig. 10 is an enlarged view of the head end of the inner tube.
Fig. 11 is an enlarged view of the head end of the outer tube.
Fig. 12 is a fitting view (extended state) of the inner tube and the outer tube.
Fig. 13 is a view showing the fitting of the inner tube and the outer tube (retracted state).
Fig. 14 shows a spiral electrode of another design.
Fig. 15 is a schematic view of the outer tube in place.
FIG. 16 is a schematic view of the inner tube threaded into the compartment.
Icon: 100-inner tube, 101-spiral electrode, 102-inner tube end tube, 103-first ring electrode, 104-second ring electrode, 105-inner tube electrode lead, 106-inner tube proximal tube body, 107-inner tube connector, M1-first positioning sensor,
200-outer tube, 201-outer tube head electrode, 202-outer tube head insulation, 203-third ring electrode, 204-outer tube end tube body, 205-outer tube cavity, 206-tee, 207-outer tube connector, M2-second positioning sensor, M3-third positioning sensor,
300-catheter handle, 301-push button, 302-housing lower cover, 303-housing upper cover, 304-fixed block, 305-gear, 306-push rod slider, 307-traction slider, 308-adjusting housing, 309-damping pad, 310-housing, 311-conical ring, 312-adjusting screw, 3131, 3132-pinion set, 314-driven gear, 315-knob, 316-handle tail cover,
401-connecting lines, 402-filling connecting lines,
501-adjustable curved catheter sheath 502-ventricular septum.
Detailed Description
The present invention will be described in detail with reference to the accompanying drawings.
The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
Example 1
As shown in fig. 1-3, a catheter assembly with an electrode capable of accessing the inside of tissue includes a catheter handle 300, an inner tube 100, and an outer tube 200, the outer tube 200 being sleeved outside the inner tube 100, the inner tube 100 being capable of sliding along the outer tube 200, the catheter handle 300 being used to manipulate the catheter (inner tube 100 and outer tube 200).
Catheter handle 300 mainly includes two functions: pushing and pulling the push button 301 can bend the adjustable bend section at the head end of the outer tube 200 for manipulating the catheter during placement of the catheter; rotation of knob 315 may cause inner tube 100 to be rotated out or retracted.
As shown in fig. 3 and 4-6, in the push-pull bending function of the catheter, the stretch bending mechanism includes a traction wire (typically, a steel wire), one end of which is disposed in the body of the outer tube 200 and one end of which is fixed to the head end of the outer tube 200, the outer tube 200 is fixed to a fixing block 304, the other end of which is fixed to a traction slide 307, the fixing block 304 is fixed to a lower cover 302 of the housing, and the push rod slide 306 is provided with a push button 301. The push rod slider 306 is slidable on the fixed block 304. The push rod slide block 306 and the traction slide block 307 are connected in a meshed manner through a gear 305, and the gear 305 plays roles of decelerating and reversing in the push-pull process so as to push and pull the traction slide block 307. When the push button 301 is pushed and pulled, the traction wire in the outer tube 200 is pulled by the stress, so that the adjustable bending section at the head end of the outer tube 200 is bent to a proper bending degree.
As shown in fig. 3, 7-9, in the rotational extension or retraction function of the head end of the inner tube 100, the outer lumen 205 is connected to the irrigation connection tube 402 and the inner tube proximal tube body 106 passes through the tapered collar 311 and the adjustment screw 312 and is secured to the driven gear 314. In the handle assembly, adjusting the adjustment screw 312 to a proper tightness between the internally threaded housing 310 serves to seal the outer lumen 205 while allowing the inner tube to rotate easily within the adjustment screw 312. The material of the conical ring 311 is preferably silicone rubber. The knob 315 is meshed through 2 pinion sets 3131, 3132, and the pinion sets 3131, 3132 function as reversing and speed regulating. When the knob 315 is rotated, the pinion sets 3131 and 3132 drive the driven gear 314 to mesh and follow, so as to drive the driven gear 314 to mesh with the lower shell cover 302 and the upper shell cover 303 (the lower shell cover 302 and the upper shell cover 303 are mutually buckled to form a handle shell together), thereby driving the inner tube proximal tube 106 to rotate, and the head end of the inner tube 100 achieves the function of extending out of the head end of the outer tube or retracting into the outer tube. The lumen at the rear end of catheter handle 300 is left with a suitable amount of space, and when inner tube 100 is rotated forward or backward, inner tube electrode lead 105 is rotated with inner tube 100 with sufficient space to avoid twisting and breaking. Moreover, since the inner tube electrode lead 105 is thinner and softer than the connection wire 401, rotational stress is not conducted to the inner tube connector 107 and the external cable connected thereto along with the connection wire 401, and there is no case where the catheter is displaced due to stress drag caused by deformation of the connection wire 401 or the external cable by rotation of the inner tube 100.
As shown in fig. 1 and 10, the head end of the inner tube 100 includes a spiral electrode 101 and two ring electrodes (a first ring electrode 103 and a second ring electrode 104), the spiral electrode 101 is preferably made of stainless steel, the two ring electrodes are preferably made of platinum iridium alloy, and the electrodes are mutually insulated. The inside 1 first positioning sensor M1 that sets up of inner tube head end is located between first ring electrode 103 and second ring electrode 104, and first positioning sensor M1 embeds in inner tube terminal pipe 102. The inner tube end tube 102 is a stainless steel braided composite tube with enough torque transmission strength, and the inner layer and the outer layer of the inner tube end tube 102 are made of high polymer materials with lower friction coefficients. To ensure smooth handling of the inner tube 100 within the outer tube 200, a hydrophilic coating may be provided on the surface of the inner tube end tube 102. The rear end of the inner tube 100 is connected to the catheter handle 300 and an inner tube connector 107 is installed.
As shown in fig. 1 and 10, the inner tube head spiral electrode 101 is used for rotating into the myocardial tissue which is expected to be ablated, and has the function of collecting the physiological signals. The first ring electrode 103 and the second ring electrode 104 are positioned at the rear end of the spiral electrode 101 and can be used for acquiring electrophysiological signals and releasing pulsed electric field ablation energy. The spiral electrode 101 is used to guide the inner tube first ring electrode 103 and the second ring electrode 104 into the myocardial tissue, and the spiral appearance and manner thereof can be variously designed, and has a function of screwing into the tissue, including but not limited to the spiral electrode form illustrated in fig. 14. A first positioning sensor M1 is embedded in the inside of the pipe body between the first ring electrode 103 and the second ring electrode 104 for positioning the head end position P1 (X1, Y1, Z1) of the inner pipe 100. The rear end of the inner tube 100 is fixed to the driven gear 314, and the rotation knob 315 can control the inner tube 100 to rotate forward or backward. The inner tube connector 107 is used to connect with a mating device to deliver positioning information, endocardial electrophysiological signals, pulsed electric field ablation energy, or radio frequency energy.
Pulsed electric field ablation techniques refer to the application of a brief high voltage to tissue, producing a localized high electric field of hundreds to thousands of volts per centimeter. This localized high electric field can cause the cell membrane to void (electroporation), thereby altering the exchange of substances within the cell membrane (the cell membrane becomes "osmotic" phenomenon). When the applied pulsed electric field at the membrane reaches a certain threshold, the exchange of substances inside and outside the membrane due to perforation of the membrane can lead to necrosis or apoptosis, creating irreversible damage. Because different tissue cells have different thresholds for irreversible damage to voltage penetration, the myocardial tissue (the threshold is relatively low) can be selectively treated by adopting a pulse electric field technology, and the myocardial tissue is not influenced by other non-target cell tissues (such as nerves, blood cells and the like), and meanwhile, the heat effect can not be generated by adopting the pulse technology due to extremely short release energy, so that the problems of tissue crusting, tissue blasting and the like are avoided.
The spiral electrode 101 at the head end of the inner tube 100 can enter the myocardial tissue by rotating, and whether the catheter head end reaches the expected focus position is judged by the electrophysiological signal change collected by the spiral electrode 101 and the position information of the positioning sensor. The spiral electrode 101 cannot be used to deliver pulsed electric field ablation energy. The lengths and the distances between the first ring electrode 103 and the second ring electrode 104 of the inner tube 100 are verified, the electrode length is preferably 1 mm-5 mm, the electrode distance is preferably 1 mm-3 mm, and the inner tube is used for transmitting pulse radio frequency energy to directly act on the inside of myocardial tissues, so that the ablation effect can be effectively improved. The first ring electrode 103 and the second ring electrode 104 may also be used for acquiring endocardial electrophysiological signals.
As shown in fig. 1 and 11, the outer tube 200 includes a head electrode 201 and more than 1 third ring electrode 203 for acquiring an endocardial electrophysiological signal. The top of the outer tubular head electrode 201 is provided with a channel for extending and retracting the head end of the inner tube 100. The outer tube 200 is internally provided with an outer lumen 205 for providing access to the inner tube 100 or for injecting a liquid. The tail of the outer tube 200 is provided with a catheter handle 300, the front end of the catheter handle 300 is provided with a control push button 301, and the tail is provided with a tee joint 206, an outer tube connector 207 and an inner tube interface. The outer tube 200 is divided into an outer tube proximal end tube body and an outer tube distal end tube body 204, and the outer tube distal end tube body 204 can be controlled to stretch, bend or straighten by controlling the push button 301 of the catheter handle 300. An outer tube tail tee 206 is used for intra-operative injection of fluids (e.g., heparin saline, contrast media, etc.), and an outer tube connector 207 is used to connect the device. The top end of the outer tube 200 is provided with 2 positioning sensors, namely a second positioning sensor M2 and a third positioning sensor M3.
As shown in FIG. 11, the top end of the outer tubular head electrode 201 is designed to be a plane, so that the surface of myocardial tissue can be vertically jacked in the heart without causing extra injury, the third ring electrode 203 is positioned at the rear part of the outer tubular head electrode 201, the electrode spacing is preferably 1 mm-5 mm, the materials of the outer tubular head electrode 201 and the third ring electrode 203 are preferably platinum iridium alloy, and the electrodes (including the head electrode and the ring electrode) are mutually insulated. The outer tip electrode 201 and the third ring electrode 203 are not intended to deliver pulsed electric field ablation energy or radiofrequency energy, but are intended to only collect electrophysiological signals.
The outer pipe 205 is made of stainless steel, the inner layer is made of high polymer material with small friction coefficient, and the composite pipe has good torque transmissibility and low friction coefficient, and is favorable for rotation control of the head end of the inner pipe. The outer layer of the outer tube is made of polymer resin.
The three positioning sensors mainly have the following three functions:
1. outer tube top end position and rotation direction:
as shown in fig. 11, the first positioning sensor M2 and the second positioning sensor M3 are located at the head end of the outer tube 200, and at the rear of the outer tube head electrode 201, the two positioning sensors are embedded in the tube wall of the outer tube end tube body 204. The first positioning sensor M2 and the second positioning sensor M3 form a first distribution plane, the first distribution plane is parallel to the axis of the outer tube 200, and a certain included angle is formed between the second positioning sensor M2 and the third positioning sensor M3, for example, the first positioning sensor M2 and the second positioning sensor M3 are parallel and coplanar to each other, and are respectively located at two sides of the tube body. In the three-dimensional model, the spatial distance between the first positioning sensor M2 and the second positioning sensor M3 is P2-P3 through the position information P2 (X2, Y2, Z2) and P3 (X3, Y3, Z3) of the first positioning sensor M2 and the second positioning sensor M3. The actual installation positions of the first and second positioning sensors M2 and M3 are known, and when the outer tube 200 moves or rotates, the position and movement state of the head end of the outer tube 200 can be calculated and displayed by the difference in position change of the first and second positioning sensors M2 and M3 and displayed in real time in the three-dimensional model.
2. Providing the bending form of the outer tube in real time during operation:
as shown in fig. 13, the inner tube 100 is disposed in the outer tube 200, and the positions among the first, second, and third positioning sensors M1, M2, and M3 are unchanged without turning the knob 315. The positions P1 and P2 (or P3) of the sensors are positioned, the spatial distances P1-P2 (or P1-P3), and the actual length between the sensors is constant and known when the knob 315 is not turned. The spatial distance between the positioning sensors changes when the outer tube 200 is bent, so that the shape of the tube body of the adjustable bending section can be indirectly calculated through integral conversion and displayed in a three-dimensional model.
3. Relative positions of the inner tube head end and the outer tube head end:
as shown in fig. 12 and 13, the inner tube 100 is positioned inside the outer tube 200, and the inner tube spiral electrode 101 can be extended or retracted from the outer tube head electrode 201 by controlling the rotation of the knob 315. The front end of the knob 315 can be used for assisting in judging the extension or retraction length of the inner tube spiral electrode 101 by providing graduations. As shown in fig. 12 and 13, when the inner tube 100 passes through the outer lumen 205 according to the position information P1 (X1, Y1, Z1) of the first positioning sensor M1 at the head end of the inner tube, the spatial distance between the positioning sensors of the inner tube 100 and the outer tube 200 can be calculated by P1-P2 (or P1-P3), and the position of the inner tube 100 in the outer tube 200 is displayed in the three-dimensional model, so as to determine the distance H that the head end of the inner tube 100 extends out of the head end of the outer tube 200.
By locating the sensor position information via the electrophysiological signals of the inner tube 100 and the outer tube 200, the position of the whole product in the heart can be determined comprehensively. In the process that the inner tube 100 and the outer tube 200 are combined to enter the expected heart position, the initial relative positions of the positioning sensors on the inner tube 100 and the outer tube 200 can be used for judging the shape of the adjustable bending section of the outer tube, so that the catheter can be controlled more conveniently and rapidly. After reaching the desired location, the depth of the inner tube 100 into the myocardial tissue may be determined by the relative positions of the tips of the inner tube 100 and the outer tube 200 as it is screwed into the myocardial tissue.
As shown in fig. 15 and 16, the catheter assembly use flow:
the first step: the femoral vein puncture is performed on the patient according to the requirements of the cardiology operation. A suitable sheath, preferably an adjustable bend catheter sheath 501, is placed.
And a second step of: the handle knob is controlled to enable the front end of the inner tube of the catheter to be retracted into the electrode of the outer tube, as shown in fig. 13, the distance H between the top end of the spiral electrode of the inner tube and the top end of the outer tube is calculated indirectly through the relative distance B between the inner tube and the magnetic positioning sensor of the outer tube. The inner and outer tubes pass through the sheath in the first step into the right ventricle. Proper heparin saline is injected into the tee joint of the outer tube, so that blood coagulation is prevented, and meanwhile, the friction force between the inner tube and the outer tube is reduced.
And a third step of: a catheter is used to build a three-dimensional model of the right ventricle with the aid of a cardiac electrophysiology three-dimensional mapping system. The sheath and catheter handle push button are manipulated until the catheter is moved to the ventricular septum 502 lesion position. In the process, the endocardial electrophysiological waveform is detected in real time through the outer tube electrode, and the head end of the inner tube is always positioned in the inner cavity of the outer tube body. The H value in the second step of the operation of the outer tube should be sufficient to prevent the spiral electrode of the inner tube from extending beyond the electrode of the outer tube head, preferably from 2mm to 8mm. And monitoring and displaying the position and the shape of the adjustable bending section of the outer tube in real time in the three-dimensional model. The catheter reaches the lesion site ready to be screwed into the inner tube spiral electrode as shown in fig. 15. The rotation of the inner tube handle is prohibited until the catheter reaches the lesion site. In this step, the operation of the handle knob is prohibited.
Fourth step: the position of the outer tube is fixed, and the handle knob is rotated, so that the inner tube spiral electrode is gradually screwed into the lesion tissue of the ventricular septum 502. In this step, monitoring the length of the inner tube extending out of the outer tube is performed by a three-dimensional model, as shown by h=a+b-C in fig. 12, a being the distance from the top end of the spiral electrode 101 to the first positioning sensor M1, B being the distance from the first positioning sensor M1 to the second positioning sensor M2 (or the third positioning sensor M3), C being the distance from the outer tube head electrode 201 to the second positioning sensor M2 (or the third positioning sensor M3), and H being the distance from the top end of the inner tube spiral electrode 101 to the top end of the outer tube head electrode 201. No penetration of the compartment 502 can occur. Meanwhile, the electrophysiological signals acquired by all catheter electrodes assist in judging whether the catheter position is correct or not. The inner tube electrode is screwed into the myocardium at the ventricular septum 502, fig. 16.
Fifth step: high-voltage pulse energy is released to focal myocardial tissue through the two ring electrodes of the inner tube.
Sixth step: the ablation effect was examined and the electrophysiological map before and after ablation was compared with the inter-electrode impedance. The pacing signal is delivered to further examine the effect of ablation.
Seventh step: and after the operation is finished, the inner tube spiral electrode is retracted into the head end of the outer tube, and all the catheters and the sheath tubes are withdrawn.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.

Claims (6)

1. The catheter assembly with the electrode capable of entering the tissue is characterized by comprising a catheter handle (300), an inner tube (100) and an outer tube (200), wherein the outer tube (200) is sleeved outside the inner tube (100), the inner tube (100) can slide along the outer tube (200), a spiral electrode (101) is arranged at the head of the inner tube (100), the spiral electrode (101) is used for rotating into the tissue and simultaneously collecting electrophysiological signals,
the catheter handle (300) is provided with a stretch bending mechanism and a rotating mechanism, the stretch bending mechanism is provided with a traction wire which can bend the adjustable bending section of the outer tube (200), the rotating mechanism is provided with a gear set which can enable the inner tube (100) to extend or retract in a rotating way,
the stretch bending mechanism comprises a fixed block (304) and a traction slide block (307), the outer tube (200) is fixedly connected with the fixed block (304), one end of the traction wire is fixed at the head end of the outer tube (200), the other end of the traction wire is fixed on the traction slide block (307), the fixed block (304) is fixed on the catheter handle (300), the fixed block (304) is slidably connected with a push rod slide block (306), the push rod slide block (306) is provided with a push button (301), the push rod slide block (306) is in meshed connection with the traction slide block (307) through a gear (305),
the rotating mechanism comprises a conical ring (311), an adjusting screw (312), gear sets (3131, 3132), a driven gear (314) and a knob (315), wherein the inner tube (100) passes through the conical ring (311), the adjusting screw (312) and is fixed with the driven gear (314), the knob (315) is arranged on the outer tube (200), the knob (315) is meshed with the driven gear (314) through the gear sets (3131, 3132),
a first ring electrode (103) and a second ring electrode (104) are arranged at the head end of the inner tube (100) at intervals, the first ring electrode (103) and the second ring electrode (104) are positioned at the rear end of the spiral electrode (101), a first positioning sensor (M1) is arranged between the first ring electrode (103) and the second ring electrode (104), the first positioning sensor (M1) is embedded in the inner tube tail end tube (102), a placement space is formed in the inner cavity at the rear end of the catheter handle (300), the placement space is used for placing an inner tube electrode wire (105), and the inner tube electrode wire (105) is connected with the spiral electrode (101), the first ring electrode (103) and the second ring electrode (104).
2. The catheter assembly of claim 1, wherein the first ring electrode (103) and the second ring electrode (104) are each 1 mm-5 mm in length, and the first ring electrode (103) and the second ring electrode (104) are spaced apart by 1 mm-3 mm.
3. A catheter assembly with an electrode accessible inside tissue according to claim 1, wherein the tip of the outer tube (200) is provided with an outer tube tip electrode (201), a third ring electrode (203), a second positioning sensor (M2) and a third positioning sensor (M3), the third ring electrode (203) being located at the rear end of the outer tube tip electrode (201), the second positioning sensor (M2) and the third positioning sensor (M3) being located at the rear end of the third ring electrode (203).
4. A catheter assembly with an electrode accessible inside tissue according to claim 3, characterized in that the second positioning sensor (M2) and the third positioning sensor (M3) form a first distribution plane, which is parallel to the axis of the outer tube (200), and that the second positioning sensor (M2) and the third positioning sensor (M3) form an angle between them.
5. A catheter assembly according to claim 3, wherein the tip of the outer tubular tip electrode (201) is planar and the distance between the outer tubular tip electrode (201) and the third ring electrode (203) is 1 mm-5 mm.
6. A catheter assembly for accessing an electrode inside a tissue according to any of claims 1-5, wherein an outer lumen (205) is provided inside the outer tube (200), the outer lumen (205) being adapted to provide access to the inner tube (100) or to inject a liquid, the outer lumen (205) being connected with a perfusion connection tube (402), the tightness between the adjusting screw (312) and the housing (310) being adjusted to seal the outer lumen (205).
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CN117426867A (en) * 2023-10-23 2024-01-23 江苏启灏医疗科技有限公司 Low-temperature plasma operation electrode

Citations (3)

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Publication number Priority date Publication date Assignee Title
WO2014029355A1 (en) * 2012-08-24 2014-02-27 Symap Medical (Suzhou) , Ltd Device for mapping and ablating renal nerves distributed on the renal artery
CN106264709A (en) * 2015-05-29 2017-01-04 上海微创电生理医疗科技有限公司 A kind of guiding catheter
CN113967065A (en) * 2021-06-23 2022-01-25 四川锦江电子科技有限公司 Pulsed electric field ablation catheter capable of entering inside of tissue

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014029355A1 (en) * 2012-08-24 2014-02-27 Symap Medical (Suzhou) , Ltd Device for mapping and ablating renal nerves distributed on the renal artery
CN106264709A (en) * 2015-05-29 2017-01-04 上海微创电生理医疗科技有限公司 A kind of guiding catheter
CN113967065A (en) * 2021-06-23 2022-01-25 四川锦江电子科技有限公司 Pulsed electric field ablation catheter capable of entering inside of tissue

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