CN117752406A - Petal pulse ablation catheter - Google Patents

Abstract

The invention discloses a petal pulse ablation catheter which comprises a handle, a main body tube, an electrode support and an inner tube, wherein the proximal end of the main body tube is connected with the handle, the distal end of the main body tube is connected with the electrode support, a ring electrode is arranged on the electrode support, and the ring electrode is electrically connected with a socket on the handle; the inner tube is worn to locate the inner chamber of main part pipe and can follow the length direction slip of main part pipe, and the inner chamber of inner tube is used for wearing to establish the seal wire. The ring electrode on the electrode bracket of the petal pulse ablation catheter is used for ablating tissue cells of a lesion part, the inner tube is additionally arranged in the main tube body, and the inner tube can slide in the inner cavity of the main tube so as to be suitable for different tissue working conditions. When the inner tube stretches out of the main body tube, the inner tube can provide a certain supporting force for the guide wire, the supporting performance and the positioning performance of the guide wire are enhanced, the ring electrode on the electrode support is better contacted with pathological tissues, and when the inner tube is retracted into the main body tube, the ring electrode on the electrode support can be ensured to be closer to the pathological tissues and better contacted with the pathological tissues.

Description

Petal pulse ablation catheter

Technical Field

The invention relates to the field of medical instruments, in particular to a petal pulse ablation catheter.

Background

Atrial fibrillation is about 3% of the prevalence in adults, and increases with age and with increasing cardiovascular complications. Worldwide atrial fibrillation patients 3350 ten thousand in 2010, 0.5% of the world population, and about 1/4 of middle-aged people in the european union and the united states will suffer from atrial fibrillation. Studies have shown that the prevalence of Chinese atrial fibrillation has increased 20-fold over the last 10 years, with a total prevalence of 0.71% in people over the age of 35, up to 7.5% in people over the age of 80, and 487 thousands in the entire patient population, with 34% of patients with atrial fibrillation not knowing their history of atrial fibrillation. By 2020, 1000 thousands of patients with atrial fibrillation are in existence in China, and along with the aging acceleration of the population of China, the number of patients and the total prevalence rate are expected to be increased more obviously in a quite long period in the future.

As one of the most common clinical arrhythmic diseases, the morbidity and mortality increases year by year. Among them, thromboembolic complications are the main cause of death and disability of atrial fibrillation, and cerebral stroke is the most common manifestation type. The cerebral apoplexy caused by atrial fibrillation accounts for 20% of all cerebral apoplexy, and compared with cerebral apoplexy related to non-atrial fibrillation, cerebral apoplexy related to atrial fibrillation has the characteristics of serious symptoms, high disability rate and easy recurrence, and the death rate of cerebral apoplexy is 2 times of cerebral apoplexy related to non-atrial fibrillation. Meanwhile, patients with Asian-atrial fibrillation are more prone to ischemic stroke than patients with African-atrial fibrillation, and the occurrence risk of the ischemic stroke is high, so that the lives of the patients are seriously endangered and the life quality of the patients is influenced.

At present, the traditional treatment method of atrial fibrillation mainly comprises the step of orally taking anticoagulant medicines such as warfarin and the like. The oral warfarin anticoagulation has more limitations, such as large dose difference among different individuals, narrow effective dose safety window, serious bleeding complications, poor patient compliance and the like; novel anticoagulants represented by dabigatran etexilate, while safer than warfarin, are expensive and still suffer from bleeding risk and poor patient compliance. Studies show that the proportion of anticoagulant withdrawal in China is up to 60% in the follow-up period of 2 years.

In recent years, the development of an electrophysiological center is rapid, and a catheter ablation technology is mature, so that the catheter ablation technology is widely applied to paroxysmal atrial fibrillation with serious symptoms and continuous atrial fibrillation treatment accompanied with high risk of cerebral apoplexy. Clinical studies show that the left atrium is the main part of atrial fibrillation, and the catheter ablation technology is the ablation technology for isolating pulmonary veins and the left atrium through percutaneous puncture, and compared with drug treatment, the catheter ablation technology has the advantages of radical treatment of atrial fibrillation and no need of taking antiarrhythmic drugs for life. The ablation techniques now commonly used can be divided into conventional radiofrequency ablation, cryoablation and emerging pulsed ablation. Rf ablation is usually a point-to-point mode, where tissue target cells are necrotized by heating, and further electrical isolation of tissue is achieved, and is suitable for atrial fibrillation, atrial flutter, etc. due to pulmonary veins or pulmonary vein formation, and has limitations in that rf energy has an effect on non-target tissues when applied to a target tissue site, for example, applying rf energy to atrial wall tissue may cause esophageal or phrenic nerve damage near the heart, and rf ablation treatment is longer, further increasing the likelihood of damage to non-target tissues or the risk of tissue crusting, and further increasing the likelihood of embolism. Cryoablation utilizes endothermic vaporization of liquefied refrigerant to substantially reduce ambient temperature. At present, the cryoballoon ablation has better adhesion between the balloon and the pulmonary vein port, so that a continuous and complete annular ablation range can be formed, and the conduction of tissue signals can be isolated by one or more ablations, so that the treatment time is shortened. But the damage incidence of cryoballoon ablation to phrenic nerves is high, and there is a certain probability of esophageal damage and pulmonary vein stenosis.

The pulse electric field ablation is used as an emerging ablation therapy, and the novel pulse electric field ablation technology can generate microsecond pulse electric fields in the ablation process and generate nanosecond micropores on cell membranes so as to realize electroporation. Compared with smooth muscle and nerve cells, the threshold value of the myocardial cells to the pulsed electric field is the lowest, so that the myocardial cells are necrotized first in the process of ablation of the pulsed electric field. Unlike conventional thermal effect-based ablation methods, pulsed electric fields are capable of selectively ablating cardiac tissue while preserving vascular, neural and pericardiac tissue. In addition, the pulse electric field carries out irreversible electroporation ablation on myocardial tissue, heat energy conduction is not needed, the ablation process is efficient and rapid, and the ablation time is obviously shortened.

Existing ablation catheters typically utilize a receiver to detect the electric field generated by electrodes on the catheter to position the catheter, which can result in inaccurate position detection due to the different impedances of the muscles and skin, thereby affecting the accuracy of the procedure.

The existing ablation catheter lacks anchoring in the operation process and makes the ablation electrode and tissue not well attached, the electrode has a single function, so that the operation process of an operator needs to continuously adjust the position of the catheter and switch the catheter, the operation time is prolonged, and the operation safety is influenced.

Disclosure of Invention

The invention aims to overcome the defect of inaccurate positioning of an ablation catheter in the prior art and provides a petal pulse ablation catheter.

The invention solves the technical problems by the following technical scheme:

the utility model provides a petal pulse ablation catheter, petal pulse ablation catheter includes handle, main part pipe, electrode support and inner tube, the proximal end of main part pipe be connected in the handle, the distal end of main part pipe be connected in electrode support, be equipped with the ring electrode on the electrode support, the ring electrode electricity connect in socket on the handle, the inner tube wears to locate the inner chamber of main part pipe and can be followed the length direction of main part pipe slides, the inner chamber of inner tube is used for wearing to establish the seal wire.

In the scheme, the handle of the petal pulse ablation catheter is used for holding, the ring electrode on the electrode support is used for ablating tissue cells of a lesion part so as to achieve tissue electric signal isolation, the inner tube is additionally arranged in the main tube body, and the inner tube can slide in the inner cavity of the main tube so as to be suitable for different tissue working conditions. When the inner tube stretches out of the main body tube, the inner tube can provide a certain supporting force for the guide wire, the supporting performance and the positioning performance of the guide wire are enhanced, the ring electrode on the electrode support can be better contacted with pathological tissues, when the inner tube is retracted into the main body tube, the ring electrode on the electrode support can be ensured to be closer to the pathological tissues and better contacted with the pathological tissues, for example, the ring electrode on the electrode support can ablate the rear wall, the mitral isthmus and other parts, and the application range of the petal pulse ablation catheter is enlarged.

In addition, because the ring electrode has a positioning function besides an ablation function, when the device is used, the socket is electrified, the ring electrode generates an electric field, then the receiver is used for detecting the ring electrode, the positioning function of the electrode bracket can be realized, further, the visual presentation of the petal pulse ablation catheter is realized, accurate reference data is provided for guiding operation, and meanwhile, the defects of low precision and great damage to a human body of the traditional X-ray detection means are overcome.

Preferably, the handle is provided with a chute extending along the length direction of the handle, the inner tube is connected with a push button, and the push button is arranged on the chute in a sliding way;

and/or the proximal end of the inner tube is connected with a luer connector, the distal end of the inner tube is connected with a tip, and one end of the tip, which is far away from the inner tube, is provided with a chamfer;

and/or the inner tube is made of an insulating material.

In the scheme, the push button is connected to the inner tube and slides in the sliding groove on the handle, so that the inner tube is convenient to push and pull manually, and the operation is simple and convenient.

The distal end of the inner tube is provided with the chamfer end, so that the damage to the vascular wall can be effectively avoided in the guiding and positioning process of the inner tube, the proximal end of the inner tube is connected with the luer connector, and physiological saline can be injected into the lesion part through the luer connector and the inner tube. Because the inner tube is made of insulating materials, the inner tube can play a role of insulating guide wires, and abnormal interference of energy in the operation process is ensured.

Preferably, the push button is provided with a fastening part, the handle is provided with a plurality of clamping grooves, the clamping grooves are arranged along the length direction of the handle, and the fastening part can be fastened in any clamping groove so as to lock the push button.

In this scheme, the buckle portion on the push button and the draw-in groove block on the handle can be with the inner tube locking for fixed inner tube head end position, better realization is to the auxiliary guide locate function of seal wire. Preferably, the handle is provided with a scale for displaying different pushing positions of the inner tube.

Preferably, the electrode support is a petal structure, the petal structure comprises an arc-shaped supporting part and a supporting rod part, two ends of the arc-shaped supporting part are respectively connected with one supporting rod part, one end, far away from the arc-shaped supporting part, of the supporting rod part is connected with the main body pipe, the ring electrode comprises an arc ring electrode and a rod ring electrode, the arc ring electrode is arranged on the arc-shaped supporting part, and the rod ring electrode is arranged on the supporting rod part.

In this scheme, the arc ring electrode on the arc supporting part is used for collecting the circumference electric signal of electrode support except having the ablation function, and the pole ring electrode on the bracing piece portion is used for collecting the axial electric signal of electrode support except having the ablation function, and the restriction of electric conduction direction can be overcome in the electric signal collection of two modes, avoids the information omission that electric signal conduction direction is different and brings, leads to petal pulse ablation catheter's position detection inaccuracy.

Preferably, the number of the petal structures is multiple, and the petal structures are spliced and connected to form an annular disc body and a cone structure connected to the center of the annular disc body.

In this scheme, adopt above-mentioned structure setting, make electrode support form central symmetry's array structure, have mutual constraint between the petal, the distance is fixed between the electrode, except guaranteeing validity and the security that melts, can also utilize the circumference of ring disk body and the electrode that axial distributes can collect circumference and axial signal, can overcome the electric conduction direction restriction, avoid the information omission that the conduction direction is different and bring, improve electrode support's position detection precision.

Preferably, the supporting rod portion has more than two curved degrees, so that the annular disc is disposed in a forward or backward tilting manner relative to the cone structure.

In this scheme, through set up the radian of a plurality of warpage on bracing piece portion, realize that the ring-shaped disk is relative to cone structure anteverted or retroverted setting to satisfy different operation demands.

The circular ring-shaped tray body is arranged in a forward tilting way relative to the cone structure, so that the arc ring electrode on the arc-shaped supporting part and the rod ring electrode on the supporting rod part are better attached to the pulmonary vein and the rear wall of the atrium, and the treatment effect is improved. Preferably, there are two curved arcs on the support shaft portion, wherein arc R1 is used to control the fit of the shaft ring electrode and arc R2 is used to control the fit of the arc ring electrode, and such a design works well for lesion sites that are approximately planar or have a smaller arc than the ablation site. The annular disc body is arranged in a backward tilting mode relative to the cone structure, and has better ablation effect on the pulmonary veins and the lesion parts of the upper cavity. Preferably, there are two radians of buckling on this bracing piece portion, and radian R3 on the bracing piece portion is used for controlling the laminating of pole ring electrode, and radian R4 is used for controlling the laminating of arc ring electrode, and R3 is slightly more than R4 for petal structure presents the retroverted.

Preferably, the main body tube is provided with a positioning electrode and a magnetic positioning piece at a position close to the electrode bracket, positioning references of the positioning electrode and the magnetic positioning piece are the same, and the positioning electrode and the magnetic positioning piece are electrically connected with a socket on the handle.

In the scheme, after the socket is electrified, the positioning electrode and the magnetic positioning piece respectively generate an electric field and a magnetic field, then the receiver is utilized to simultaneously detect the electric signal and the magnetic signal, and because the positioning reference of the positioning electrode and the magnetic positioning piece is the same, the accurate positioning of the main body tube and the electrode bracket is realized, compared with the detection means of a single positioning electrode or magnetic positioning piece, the position detection precision is higher, accurate reference data is provided for guiding operation, and the defects of low precision and great harm to human bodies of the traditional X-ray detection means are overcome.

Preferably, the petal pulse ablation catheter further comprises a handle sealing assembly and a liquid injection tube, wherein the handle sealing assembly is arranged between the main body tube and the inner tube and used for sealing the proximal end of a ring cavity formed between the inner tube and the main body tube, one end of the liquid injection tube is communicated with the ring cavity through the handle sealing assembly, and the other end of the liquid injection tube is connected with a luer connector.

In this scheme, the handle seal assembly is used for sealing the proximal end of the ring chamber that forms between inner tube and the main part pipe, still is used for connecting annotating the liquid pipe, and when the liquid of pouring into in annotating the liquid pipe, the distal end of ring chamber flows out, finally flows to pathological change position, prevents that liquid from flowing out from the proximal end of ring chamber. In the operation process, normal saline is injected into the liquid injection tube, so that thrombus is prevented from forming in the inner cavity of the main body tube and the distal end of the main body tube.

Preferably, the main body tube comprises a bendable section and a non-bendable section which are connected with each other, the bendable section is arranged at the far end of the main body tube, two control wires are arranged in the bendable section, a knob is arranged on the handle, the two control wires pass through the non-bendable section and are respectively connected with two sides of the knob,

when the knob is rotated clockwise or counterclockwise, the knob pulls the control wire on one side or the other, bending the bendable section relative to the axis of the main body tube in a direction toward one side or the other.

In this scheme, when rotatory knob, the knob pulls the control silk, makes the flexible section of main part pipe crooked, and then makes electrode support orientation different directions, increases petal pulse ablation catheter's accommodation. When the rotation direction of the knob is changed, the control wire driven by the knob is correspondingly changed, and meanwhile, the bending direction of the bendable section is changed.

Preferably, the knob has a locking member thereon, and the knob can be locked or unlocked by rotating the locking member.

In this scheme, through rotatory locking piece, can lock the knob, and then fix the angle of the distal end of main part pipe.

On the basis of conforming to the common knowledge in the field, the above preferred conditions can be arbitrarily combined to obtain the preferred examples of the invention.

The invention has the positive progress effects that: the handle of the petal pulse ablation catheter is used for holding, the ring electrode on the electrode support is used for ablating tissue cells of a lesion part so as to achieve tissue electric signal isolation, and the inner tube is additionally arranged in the main tube body and can slide in the inner cavity of the main tube so as to be suitable for different tissue working conditions. When the inner tube stretches out of the main body tube, the inner tube can provide a certain supporting force for the guide wire, the supporting performance and the positioning performance of the guide wire are enhanced, the ring electrode on the electrode support can be better contacted with pathological tissues, when the inner tube is retracted into the main body tube, the ring electrode on the electrode support can be ensured to be better contacted with the pathological tissues, for example, the ring electrode on the electrode support can ablate the positions of the back wall, the mitral isthmus and the like, and the application range of the petal pulse ablation catheter is enlarged.

Meanwhile, the end head with the chamfer is arranged at the distal end of the inner tube, so that the damage to the vascular wall can be effectively avoided in the guiding and positioning processes of the inner tube, the luer connector is connected with the proximal end of the inner tube, and physiological saline can be injected into the lesion part through the luer connector and the inner tube. Because the inner tube is made of insulating materials, the inner tube can play a role of insulating guide wires, and abnormal interference of energy in the operation process is ensured.

In addition, because the ring electrode has a positioning function besides an ablation function, when the device is used, the socket is electrified, the ring electrode generates an electric field, then the receiver is used for detecting the ring electrode, the positioning function of the electrode bracket can be realized, further, the visual presentation of the petal pulse ablation catheter is realized, accurate reference data is provided for guiding operation, and meanwhile, the defects of low precision and great damage to a human body of the traditional X-ray detection means are overcome.

Drawings

Fig. 1 is a schematic view of a petal pulse ablation catheter according to a preferred embodiment of the present invention.

Fig. 2 is an enlarged view of a portion a in fig. 1.

Fig. 3 is an enlarged view of fig. 2, partially broken away at B.

Fig. 4 is a schematic view showing the internal structure of a petal pulse ablation catheter according to a preferred embodiment of the present invention.

FIG. 5 is a schematic view of a handle seal assembly according to a preferred embodiment of the present invention.

Fig. 6 is a schematic structural view of a cross section of a petal pulse ablation catheter in accordance with a preferred embodiment of the present invention.

Fig. 7 is a schematic longitudinal sectional view of a main body tube according to a preferred embodiment of the present invention.

Fig. 8 is a second schematic structural view of a petal pulse ablation catheter according to a preferred embodiment of the present invention.

Fig. 9 is a schematic diagram of a petal pulse ablation catheter according to a preferred embodiment of the present invention.

Fig. 10 is a schematic view of an electrode holder according to a preferred embodiment of the present invention.

Fig. 11 is a schematic diagram of an electrode holder according to a preferred embodiment of the invention.

Fig. 12 is a schematic view of a structure of a supporting rod portion (forward tilting) according to a preferred embodiment of the present invention.

Fig. 13 is a schematic illustration of a petal pulse ablation catheter and pulmonary vein abutment (anteversion) according to a preferred embodiment of the present invention.

Fig. 14 is a schematic illustration of a petal pulse ablation catheter and atrial backwall abutment (anteversion) according to a preferred embodiment of the present invention.

Fig. 15 is a schematic view of an electrode holder according to a preferred embodiment of the present invention.

Fig. 16 is a schematic structural view of a supporting rod portion according to a preferred embodiment of the present invention.

Fig. 17 is a second schematic view of a petal pulse ablation catheter and pulmonary vein abutment (retroversion) according to a preferred embodiment of the present invention.

Fig. 18 is a second schematic view of a petal pulse ablation catheter and atrial backwall abutment (retroversion) according to a preferred embodiment of the present invention.

Reference numerals illustrate:

handle 1, knob 11, locking member 111, socket 12

Body tube 2, positioning electrode 21, magnetic positioning member 22, non-bendable section 23, bendable section 24, reinforced composite tube 25, inner layer 251, intermediate layer 252, outer layer 253, middle carrier tube 26

Electrode holder 3, ring electrode 30, arc-shaped support portion 31, arc ring electrode 311, support rod portion 32, rod ring electrode 321, annular disk 33, cone structure 34

Inner tube 4, luer fitting 41, tip 42, push button 43

Handle seal assembly 5, seal body 51, seal ring 52, seal cap 53

Liquid filling pipe 6

Luer fitting 61

Control yarn 7

Wire 8

Sheath tube 9

Guide wire 100

Radian R1, radian R2, radian R3, radian R4

Detailed Description

The invention will now be more fully described by way of example only and with reference to the accompanying drawings, but the invention is not thereby limited to the scope of the examples described.

As shown in fig. 1-18, this embodiment discloses a petal pulse ablation catheter, which comprises a handle 1, a main body tube 2, an electrode support 3 and an inner tube 4, wherein the proximal end of the main body tube 2 is connected with the handle 1, the distal end of the main body tube 2 is connected with the electrode support 3, a ring electrode 30 is arranged on the electrode support 3, and the ring electrode 30 is electrically connected with a socket on the handle 1 through a lead 8. The inner tube 4 is provided through the inner cavity of the main body tube 2 and can slide along the length direction of the main body tube 2. The proximal end of the inner tube 4 is connected with a luer connector 41, the distal end of the inner tube 4 is connected with a tip 42, one end of the tip 42 far away from the inner tube 4 is provided with a chamfer, the inner cavity of the inner tube 4 is used for penetrating a guide wire 100, and the inner tube 4 is made of an insulating material.

In this embodiment, the handle 1 of the petal pulse ablation catheter is used for holding, the ring electrode 30 on the electrode support 3 is used for ablating tissue cells of a lesion part so as to achieve tissue electrical signal isolation, and the inner tube 4 is additionally arranged in the main tube body 2, and the inner tube 4 can slide in the inner cavity of the main tube 2 so as to be suitable for different tissue working conditions. When the inner tube 4 extends out of the main body tube 2, the inner tube 4 can provide a certain supporting force for the guide wire 100, the supporting performance and the positioning performance of the guide wire 100 are enhanced, the ring electrode 30 on the electrode support 3 can be better contacted with pathological tissues, when the inner tube 4 is retracted into the main body tube 2, the ring electrode 30 on the electrode support 3 can be ensured to be closer to the pathological change position and better contacted with the pathological change tissues, for example, the ring electrode 30 on the electrode support 3 can ablate the parts such as the back wall, the mitral isthmus and the like, and the application range of the petal pulse ablation catheter is enlarged.

Meanwhile, the chamfer end 42 is arranged at the distal end of the inner tube 4, so that the damage to the vascular wall can be effectively avoided in the guiding and positioning process of the inner tube 4, the luer connector 41 is connected to the proximal end of the inner tube 4, and physiological saline can be injected into the lesion part through the luer connector 41 and the inner tube 4. Since the inner tube 4 is made of an insulating material, the inner tube 4 can function as an insulating guide wire 100, ensuring abnormal interference of energy during the operation. The inner tube 4 is generally made of biocompatible polymer materials such as Pebax, nylon or PI.

In addition, since the ring electrode 30 has a positioning function in addition to an ablation function, when the device is used, the socket 12 is electrified, the ring electrode 30 generates an electric field, then the receiver is used for detecting the ring electrode 30, the positioning function of the electrode bracket 3 can be realized, further the visual presentation of the petal pulse ablation catheter is realized, accurate reference data is provided for guiding operation, and the defects of low accuracy and great damage to a human body of the traditional X-ray detection means are overcome.

As shown in fig. 6 and 7, the main body tube 2 includes a reinforcing composite tube 25 and a middle tube 26, the reinforcing composite tube 25 is sleeved outside the middle tube 26, and the electrode holder 3 is connected to the distal end portion of the middle tube 26. The reinforced composite tube 25 includes an inner layer 251, an intermediate layer 252 and an outer layer 253, wherein the inner layer 251 is a PTFE (polytetrafluoroethylene) layer, the intermediate layer 252 is a metal wire-wound or woven reinforcing layer, and the outer layer 253 is a biocompatible polymer material such as Pebax (nylon elastomer), nylon or TPU (polyurethane rubber). The middle support tube 26 is generally made of biocompatible polymer materials such as Pebax, nylon, and PI (polyimide).

As shown in fig. 8 and 9, a sliding groove (not shown in the drawings) extending along the length direction of the handle 1 is arranged on the handle 1, a push button 43 is connected to the inner tube 4, and the push button 43 is slidably arranged in the sliding groove, so that the inner tube 4 can be pushed and pulled manually, and the operation is simple and convenient. The push button 43 has a locking portion (not shown) provided with a plurality of locking grooves (not shown) on the handle 1, the plurality of locking grooves being arranged along the length direction of the handle 1, and the locking portion being capable of locking any one of the locking grooves to lock the push button 43. The push button 43 can realize positioning in the travel range, and when the clamping part on the push button 43 is clamped with the clamping groove on the handle 1, the inner tube 4 can be locked for fixing the head end position of the inner tube 4, so that the auxiliary guiding and positioning function of the guide wire 100 is better realized. Preferably, the handle 1 is provided with a scale, which is located beside the clamping groove and is used for displaying different pushing positions of the inner tube 4.

In other alternative embodiments, the push button may also be in an electric mode to facilitate intelligent control, thereby enabling movement of the inner tube.

As shown in fig. 10 to 18, the electrode holder 3 has a petal structure including an arc-shaped support portion 31 and a support rod portion 32, both ends of the arc-shaped support portion 31 are respectively connected to a support rod portion 32, one end of the support rod portion 32 remote from the arc-shaped support portion 31 is connected to the main body tube 2, the ring electrode 30 includes an arc ring electrode 311 and a rod ring electrode 321, the arc ring electrode 311 is provided on the arc-shaped support portion 31, and the rod ring electrode 321 is provided on the support rod portion 32. The arc ring electrode 311 on the arc-shaped support portion 31 is used for collecting electric signals in the circumferential direction of the electrode holder 3 in addition to ablating cells, and the rod ring electrode 321 on the support rod portion 32 is used for collecting electric signals in the axial direction of the electrode holder 3 in addition to ablating cells. The signal collection of the ring electrode 30 on the electrode support 3 is to detect the electric signal of the ring electrode 30 by using a receiver, so as to realize the positioning function of the electrode support 3. The electric signal collection of the arc ring electrode 311 on the arc supporting part 31 and the rod ring electrode 321 on the supporting rod part 32 can overcome the limitation of the electric conduction direction, and avoid information omission caused by different electric signal conduction directions, so that the position detection of the ablation catheter is inaccurate.

Preferably, two arc ring electrodes 311 with preset intervals are provided on the arc-shaped supporting portion 31, and are used for displaying positioning in addition to the ablation function.

The number of arc ring electrodes 311 on the arc-shaped support portion 31 may be set as needed, and the number of rod ring electrodes 321 on the support rod portion 32 may be set as needed.

As shown in fig. 10, 11 and 15, the number of petal structures is multiple, the petal structures are spliced and connected to form a circular ring-shaped disc body 33 and a cone structure 34 connected to the center of the circular ring-shaped disc body 33, so that the electrode support 3 forms a central symmetrical array structure, the petals are mutually restrained, the distance between the electrodes is fixed, the arc ring electrodes 311 are uniformly distributed in the circumferential direction of the circular ring-shaped disc body 33, the rod ring electrodes 321 are uniformly distributed in the circumferential direction of the cone structure 34, high-density ablation can be realized, meanwhile, accurate detection and positioning can be realized, and the effectiveness and safety of ablation and detection are ensured. The circumferential and axial electric signals can be collected by using the circumferentially and axially distributed electrodes of the annular disk body 33, so that the limitation of the electric conduction direction can be overcome, information omission caused by different conduction directions can be avoided, and the position detection precision of the electrode support 3 can be improved.

The number of the support rod portions 32 of the electrode holder 3 is generally 4 to 8, the number of the rod ring electrodes 321 is generally 1 to 5, and the number of the arc ring electrodes 311 is limited by the diameter actually set by the petals and is generally 10 to 20.

The arc-shaped supporting portion 31 is made of a biocompatible material, such as Pebax or PU (polyurethane), and the ring electrode 30 is made of platinum, platinum iridium alloy, gold, or the like.

The support rod portion 32 and the arc-shaped support portion 31 each include a housing and a shaping wire, the shaping wire is embedded in the housing or the housing is sleeved outside the shaping wire, and the shaping wire is used for supporting and maintaining a preset shape of the petal structure. The shaping wire is made of nickel or nickel-titanium alloy, the shell is made of biocompatible polymer materials such as Pebax, nylon or PI.

As shown in fig. 10 to 18, the support rod portion 32 has two or more curved degrees so that the petal structure can be preset to be tilted forward or backward, that is, the annular disc 33 is tilted forward or backward with respect to the cone structure 34. In using the ablation catheter, a pathway is established at the treatment site using the sheath 9, and then the main body tube 2 of the ablation catheter is inserted into the sheath 9 and guided and positioned by the guidewire 100 to the target location. As shown in fig. 10 to 14, the annular disk 33 is disposed obliquely forward with respect to the cone structure 34, so that the arc ring electrode 311 on the arc support portion 31 and the rod ring electrode 321 on the support rod portion 32 are better attached to the pulmonary veins and the atrial back wall, and the therapeutic effect is improved. As shown in fig. 12, there are two curved radians on the supporting rod portion 32 disposed in a forward tilting manner, wherein the radian R1 is used for controlling the attachment of the rod ring electrode 321, and the radian R2 is used for controlling the attachment of the arc ring electrode 311, and this design is better for the lesion portion having an approximate plane or smaller radian with the ablation portion. 15-18, the annular disc 33 is disposed in a backward tilting manner relative to the cone structure 34, and has a better ablation effect on the pulmonary veins and the lesion sites of the upper cavity. As shown in fig. 16, there are two curved radians on the support rod portion 32 disposed in a backward tilting manner, the radian R3 on the support rod portion 32 is used for controlling the attachment of the rod ring electrode 321, the radian R4 is used for controlling the attachment of the arc ring electrode 311, and R3 is slightly greater than R4, so that the petal structure presents a backward tilting state.

As shown in fig. 1 to 3, the main body tube 2 is provided with a positioning electrode 21 and a magnetic positioning member 22 at a position close to the electrode holder 3, and the positioning reference of the positioning electrode 21 and the magnetic positioning member 22 is the same, and the positioning electrode 21 and the magnetic positioning member 22 are electrically connected to a socket on the handle 1. After the socket is electrified, the positioning electrode 21 and the magnetic positioning piece 22 respectively generate an electric field and a magnetic field, then the electric signal and the magnetic signal are detected simultaneously by the receiver, and because the positioning reference of the positioning electrode 21 and the magnetic positioning piece 22 is the same, the accurate positioning of the main body tube 2 and the electrode bracket 3 is realized, compared with the detection means of a single positioning electrode or magnetic positioning piece, the position detection precision is higher, accurate reference data is provided for guiding operation, and the defects of low precision and great harm to human bodies of the traditional X-ray detection means are overcome.

As shown in fig. 1, 4 and 5, the ablation catheter further comprises a handle seal assembly 5 and an infusion tube 6, wherein the handle seal assembly 5 is installed between the main body tube 2 and the inner tube 4 and is used for sealing the proximal end (the end far away from the electrode support 3) of an annular cavity formed between the inner tube 4 and the main body tube 2, one end of the infusion tube 6 is communicated with the annular cavity through the handle seal assembly 5, and the other end of the infusion tube 6 is connected with a luer connector 61. The handle seal assembly 5 comprises a seal body 51, a seal ring 52 and a seal cap 53, wherein the seal cap 53 is connected to the seal body 51 through the seal ring 52 and seals the inner cavity of the seal body 51, and the inner cavity of the seal body 51 is respectively communicated with the annular cavities formed between the liquid injection pipe 6 and the inner pipe 4 and the main body pipe 2. When liquid is injected into the injection tube 6 through the luer 61, the liquid flows into the inner cavity of the seal body 51, then flows into the annular cavity and flows out from the distal end of the annular cavity (the end near the electrode holder 3), and finally flows toward the lesion, preventing the liquid from flowing out from the proximal end of the annular cavity. During the operation, normal saline is injected into the liquid injection tube 6, so that thrombus is prevented from forming in the inner cavity of the main body tube 2 and the distal end of the main body tube 2 during the operation.

As shown in fig. 2 and 9, the main body tube 2 includes a bendable section 24 and a non-bendable section 23 connected to each other, the bendable section 24 is disposed at a distal end of the main body tube 2, two control wires 7 are disposed in the bendable section 24, a knob 11 is disposed on the handle 1, and the two control wires 7 pass through the non-bendable section 23 and are connected to both sides of the knob 11, respectively. When the knob 11 is rotated clockwise or counterclockwise, the knob 11 pulls the control wire 7 on one side or the other, bending the bendable section 24 in one direction or the other with respect to the axis of the main body tube 2. When the rotation direction of the knob 11 is changed, the control wire 7 driven by the knob 11 is changed accordingly, and the bending direction of the bendable section 24 is changed. As shown in fig. 9, for example, when the knob 11 is rotated clockwise, the knob 11 pulls the lower control wire 7 to bend the bendable section 24 of the main body tube 2 downward, thereby making the electrode holder 3 downward and increasing the scope of application of the ablation catheter. When the knob 11 is rotated counterclockwise, the knob 11 pulls the upper control wire 7 to bend the bendable section 24 of the main body tube 2 upward, thereby making the electrode holder 3 upward and increasing the adaptation range of the ablation catheter.

In this embodiment, the control wire 7 is provided in the wall surface of the main body tube 2, and can deflect the bendable section 24 upward or downward within 90 ° to 135 °.

As shown in fig. 8 and 9, the knob 11 has a locking piece 111 thereon, and the knob 11 can be locked or unlocked by rotating the locking piece 111. By rotating the locking member 111, the knob 11 can be locked, and the angle of the distal end of the main body tube 2 can be fixed, and accordingly, the position and orientation of the electrode holder 3 can be fixed, thereby facilitating the ablation operation.

The two ends in the longitudinal direction of the main body tube 2 are defined herein as a front end and a rear end, respectively, wherein the front end is an end close to the electrode holder 3 and the rear end is an end far from the electrode holder 3.

In the description herein, it should be understood that the terms "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like indicate or are based on the orientation or positional relationship shown in the drawings, merely to facilitate describing the invention and simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the invention.

While specific embodiments of the invention have been described above, it will be appreciated by those skilled in the art that this is by way of example only, and the scope of the invention is defined by the appended claims. Various changes and modifications to these embodiments may be made by those skilled in the art without departing from the principles and spirit of the invention, but such changes and modifications fall within the scope of the invention.

Claims (10)

1. The utility model provides a petal pulse ablation catheter, its characterized in that, petal pulse ablation catheter includes handle, main part pipe, electrode support and inner tube, the proximal end of main part pipe connect in the handle, the distal end of main part pipe connect in electrode support, be equipped with the ring electrode on the electrode support, the ring electrode electricity connect in socket on the handle, the inner tube wears to locate the inner chamber of main part pipe and can follow the length direction of main part pipe slides, the inner chamber of inner tube is used for wearing to establish the seal wire.

2. The petal pulse ablation catheter according to claim 1, wherein a chute extending along the length direction of the handle is arranged on the handle, a push button is connected to the inner tube, and the push button is arranged on the chute in a sliding manner;

and/or the proximal end of the inner tube is connected with a luer connector, the distal end of the inner tube is connected with a tip, and one end of the tip, which is far away from the inner tube, is provided with a chamfer;

and/or the inner tube is made of an insulating material.

3. The petal pulse ablation catheter according to claim 2, wherein the push button has a locking portion, the handle has a plurality of locking grooves, the plurality of locking grooves are arranged along a length direction of the handle, and the locking portion can be locked in any one of the locking grooves to lock the push button.

4. The petal pulse ablation catheter according to claim 1, wherein the electrode holder is in a petal structure, the petal structure comprises an arc-shaped supporting portion and a supporting rod portion, two ends of the arc-shaped supporting portion are respectively connected to one supporting rod portion, one end, far away from the arc-shaped supporting portion, of the supporting rod portion is connected to the main body tube, the ring electrode comprises an arc ring electrode and a rod ring electrode, the arc ring electrode is arranged on the arc-shaped supporting portion, and the rod ring electrode is arranged on the supporting rod portion.

5. The petal pulse ablation catheter of claim 4, wherein the number of petal structures is a plurality, and wherein the plurality of petal structures are spliced to form an annular disc and a cone structure connected to the center of the annular disc.

6. The petal pulse ablation catheter of claim 5, wherein said support shaft portion has an arc of two or more warps to provide a forward or backward tilt of said annular disc relative to said cone structure.

7. The petal pulse ablation catheter of claim 1, wherein the body tube is provided with a positioning electrode and a magnetic positioning member adjacent to the electrode support, and wherein the positioning reference of the positioning electrode and the magnetic positioning member are identical, and wherein the positioning electrode and the magnetic positioning member are electrically connected to a socket on the handle.

8. The petal pulse ablation catheter of claim 1, further comprising a handle seal assembly mounted between the main body tube and the inner tube for sealing a proximal end of an annular cavity formed between the inner tube and the main body tube, and an infusion tube having one end in communication with the annular cavity through the handle seal assembly and the other end connected to a luer fitting.

9. The petal pulse ablation catheter of claim 1, wherein said main body tube comprises a bendable section and a non-bendable section connected to each other, said bendable section is disposed at a distal end of said main body tube, two control wires are disposed in said bendable section, a knob is disposed on said handle, two control wires pass through said non-bendable section and are connected to both sides of said knob respectively,

when the knob is rotated clockwise or counterclockwise, the knob pulls the control wire on one side or the other, bending the bendable section relative to the axis of the main body tube in a direction toward one side or the other.

10. The petal pulse ablation catheter of claim 9, wherein said knob has a locking member thereon, said knob being lockable or unlockable by rotating said locking member.