CN216294238U

CN216294238U - Pulse and cryoablation integrated machine

Info

Publication number: CN216294238U
Application number: CN202022866567.0U
Authority: CN
Inventors: 赵乾成; 赵峰; 王慧
Original assignee: Shanghai Shangyang Medical Technology Co ltd
Current assignee: Shanghai Shangyang Medical Technology Co ltd
Priority date: 2020-12-03
Filing date: 2020-12-03
Publication date: 2022-04-15
Anticipated expiration: 2030-12-03

Abstract

The utility model provides a pulse and cryoablation integrated machine which comprises a pulse and cryogenerator, a connecting cable, a refrigeration medium transmission pipe, a catheter and a balloon, wherein the pulse and cryogenerator is connected with the connecting cable; the pulse and freezing generator has two functions of pulse and cryoablation, and the interface of the pulse and freezing generator can be selected; the connecting cable connects the pulse and freezing generator with the catheter to transmit pulse energy, and the refrigerant transmission pipe transmits the refrigerant generated by the pulse and freezing generator to the balloon; the balloon surrounds the catheter, the tail end of the catheter extends out of the far end of the balloon and folds back to surround the outer surface of the balloon, and a plurality of groups of electrodes are arranged on the catheter and used as pulse electrodes to extract electrocardiosignals; when pulse ablation is selected, discharging between the electrodes to realize pulse ablation; when cryoablation is selected, refrigerant is delivered to the distal end of the balloon to produce a freezing effect, and the electrodes extract electrocardiosignals. The utility model realizes the selective use of pulse and cryoablation and is safer.

Description

Pulse and cryoablation integrated machine

Technical Field

The utility model relates to the field of medical instruments, in particular to an integrated pulse and cryoablation machine.

Background

Atrial Fibrillation (AF) is one of the most common clinical arrhythmias, stroke and other thromboembolic events caused by it are the main causes of death or disability of patients, and the total incidence of atrial fibrillation is about 2% as shown by multi-national clinical studies, and the incidence of atrial fibrillation is increasing gradually in recent years. The non-drug treatment of atrial fibrillation is a research hotspot in recent years, and many clinical studies at home and abroad prove that the recurrence of atrial fibrillation can be effectively prevented by applying a catheter radio frequency ablation technology to successfully electrically isolate pulmonary veins. Catheter ablation is dominated by radio frequency energy, but there are other sources of energy (including cryo-, ultrasound-, and laser ablation, etc.). However, these thermal/cold conduction based ablations have certain limitations, lack of selectivity for tissue destruction in the ablation region, and rely on catheter abutment, which can cause damage to the adjacent esophagus, coronary arteries, phrenic nerve, and the like.

Currently, guidelines recommend catheter ablation as a first line treatment for patients with symptomatic atrial fibrillation, especially for drug refractory patients with atrial fibrillation. Pulmonary Vein Isolation (PVI) is the cornerstone of catheter ablation and is also the main modality of atrial fibrillation Ablation (AF) treatment. Conventional radiofrequency ablation is mainly characterized in that when current flows through affected tissues, the current is converted into heat energy through the impedance effect of the tissues, the heat energy is conducted to adjacent tissues through conduction and small radiation effect to generate small-range tissue damage, namely so-called point-by-point ablation, and segmental or annular pulmonary vein electrical isolation is further completed through the point-by-point ablation to form complete pulmonary vein-left atrium electrical isolation, namely PVI. However, the technology has relatively high operation difficulty, long ablation time, long learning curve, high requirement on an operator and obvious pain of a patient in the operation. In addition, when some patients melt pulmonary veins by radio frequency, transmural injuries cannot be formed, pulmonary vein leak points are easy to form, and atrial fibrillation relapse is caused. In recent years, the cryoballoon ablation is gradually becoming one of the important means for catheter ablation to treat atrial fibrillation, and the cryoballoon ablation is pointed out to become a standard ablation method for catheter ablation of atrial fibrillation in the consensus of experts of the american society for cardiac rhythm as early as 2012. While the national guidelines for atrial fibrillation also indicate that cryoballoon ablation can be used for PVI. Although complications of atrial fibrillation cryoballoon ablation tend to be reduced along with the accumulation of experience and the continuous improvement of related freezing systems and cryoballoon catheter design and production technologies, the incidence rate of the complications can still reach 5%, the consequences are serious once some complications (such as phrenic nerve injury, atrial and esophageal fistula and the like) occur, new energy is needed to assist the cryoballoon ablation, so that the complications with serious consequences to the esophageal fistula/phrenic nerve and the like can be reduced. Unlike conventional energy, pulsed electric field energy forms irreversible micropores in cell membranes by transient discharge, causing apoptosis, achieving the goal of non-thermal ablation, also known as irreversible electroporation. Currently, electroporation ablation has been used as an effective means of destroying malignant tumor tissue. Pulsed electric field ablation can theoretically damage myocardial cells without heating the tissue, and has cell/tissue selectivity, protecting surrounding critical structures. The perioperative period of avoiding the radio frequency ablation and cryoablation to treat the symptomatic atrial fibrillation has certain complications, and part of patients can relapse. The pulse electric field energy can cause apoptosis by forming nano-scale pores on cell membranes, and has the characteristics of nonthermal property and tissue selectivity, such as ablation near the esophagus at the lower left and ablation near the diaphragm at the upper right, target tissue damage is caused by using pulse ablation, and the esophagus and the diaphragm are not affected at all.

However, in the existing treatment, in part of the myocardial region, the use of cryoablation is safer, and in addition, the thick-wall region needs to make an ablation focus deeper to penetrate the wall and needs to be realized by using cryoablation; pulse ablation is needed when the left inferior pulmonary vein or certain malformed pulmonary veins are close to the esophagus, and pulse ablation is used when the right superior pulmonary vein is close to the diaphragm muscle, and extra catheters are not needed to be cryoablated to stimulate the phrenic nerve; therefore, an instrument has two functions, can greatly shorten the operation time, improve the success, and reduce the complications and the pain of a patient, so that the utility model needs to invent the instrument which can be compatible with pulse and cryoablation.

Disclosure of Invention

The utility model aims to solve the ablation problem of the existing heart rate market, and provides an instrument which can select a proper ablation mode according to the conditions of a patient and a focus, so that the pain of the patient is reduced, and the safety and the effectiveness of an operation are improved.

In order to achieve the purpose, the utility model provides an integrated pulse and cryoablation machine, which comprises a pulse and cryogenerator, a connecting cable, a refrigerating medium transmission pipe, a catheter and a balloon; the pulse and freezing generator has two functions of pulse and cryoablation, and the interface of the pulse and freezing generator can be selected; the connecting cable connects the pulse and freezing generator with the catheter to transmit pulse energy, and the refrigerant transmission pipe transmits the refrigerant generated by the pulse and freezing generator to the balloon; the balloon surrounds the catheter, the tail end of the catheter extends out of the far end of the balloon and folds back to surround the outer surface of the balloon, and a plurality of groups of electrodes are arranged on the catheter and used as pulse electrodes to extract electrocardiosignals; when pulse ablation is selected, discharging between the electrodes to realize pulse ablation; when cryoablation is selected, refrigerant is delivered to the distal end of the balloon to produce a freezing effect, and the electrodes extract electrocardiosignals.

The pulse freezing generator is connected with the pulse generator, and when the pulse discharges, the detector controls the on-off of the circuit, and only the detector detects the R wave, the discharge can be carried out. The pulse generator and the freezing generator are respectively connected with the electrodes through the positive electrode socket and the negative electrode socket, so that the positive electrode and the negative electrode can be separated, and the pulse ablation is safer.

The saccule has an inner layer and an outer layer, and the outer layer of the saccule is directly contacted with myocardial tissues. The two ends of the inner balloon and the outer balloon are connected with the catheter. The sensor is arranged between the inner layer and the outer layer of the balloon to sense the pressure change between the inner layer and the outer layer. The sensor is arranged in the saccule, and when the saccule is damaged by external force or other reasons, the sensor gives an alarm. The outer balloon is applied against the pulmonary vein during cryoablation, and the catheter tip return portion is applied snugly around the outer balloon surface.

The catheter is a multi-lumen tube with a bidirectionally deflectable, adjustable bend section at the distal portion of the catheter, and the electrode is located at the distal end of the catheter. At least two cavities in the multi-cavity catheter tube are provided with bending control pull wires which are connected to the control end of the handle, and the adjustable bending section of the catheter can be deflected in two directions by controlling the handle. The bending control stay wire is wrapped by the bending control stay wire cavity, so that the stay wire is prevented from being bent or broken due to stress concentration. The bending control stay wire cavity and the multi-cavity tube are bonded together through hot melting or reflow welding, and the functions of protecting the stay wire and reducing the friction between the stay wire and the multi-cavity tube are achieved.

The catheter is a multi-lumen tube wherein at least one lumen is an evacuation lumen. At least one cavity tube is a refrigerant liquid inlet tube, the refrigerant liquid inlet tube transmits a refrigeration medium, and the far end of the refrigerant liquid inlet tube is of a spiral structure and is provided with a plurality of small holes. The catheter is a multi-lumen tube with at least one lumen containing a cryoballoon sensor wire. At least one lumen houses a pulsatile ablation catheter wire. A pulsed ablation catheter wire may emit pulsed energy and map intracardiac signals. A gap exists between the pulse ablation catheter wire and the cavity in which it is housed through which saline or contrast agents may pass.

The utility model has the advantages that the freezing saccule and the pulse ablation can be synchronously carried out on the other catheter, a proper ablation mode can be selected according to the patient and the focus condition, the pulse catheter is designed into a shape which can be well attached to the saccule, and the success rate of the ablation is increased; the balloon is turned over at the far end of the balloon, so that the length of the far end section of the balloon is reduced, and extraction of pulmonary vein potential is facilitated. The sensor wire is arranged in the balloon, so that an alarm can be given in time when the corresponding balloon is damaged by external force or machinery accurately. The high-low voltage socket is separated, so that the risk of operation is reduced; the surface of the electrode is subjected to insulation treatment, so that bubbles are prevented from being generated when the edge of the electrode discharges.

The utility model has the functions of cryoablation and pulse ablation, wherein, the operator can select the ablation mode according to the needs of the focus, thereby ensuring the transmural property of the ablation and avoiding the omission of target spots. The shape that the pulse catheter designed into, with the laminating that the sacculus can be fine, increased the success rate of melting. The far-end balloon of the balloon is folded, so that the length of the far section is reduced, the positive and negative sockets of the extraction ablation electrode of the pulmonary vein potential can be separated, and the electrical safety is ensured.

In order to make the aforementioned and other objects, features and advantages of the present invention comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic structural diagram of the present invention.

FIG. 2 is a schematic cross-sectional view of the structure of FIG. 1A-A.

Fig. 3 is an enlarged schematic view of balloon segment B.

Fig. 4 is an enlarged schematic view of the catheter tip.

Fig. 5 is a schematic view of a distal end use state of the balloon.

Fig. 6 is a flowchart of an ablation process.

Detailed Description

The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the utility model, and not restrictive of the full scope of the utility model. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the utility model, as claimed, but is merely representative of selected embodiments of the utility model. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without making any creative effort, shall fall within the protection scope of the present invention.

The present invention is described in further detail below to enable those skilled in the art to practice the utility model with reference to the description.

Referring to fig. 1, fig. 1 is a schematic structural diagram of the present invention. The utility model is further explained with reference to the accompanying drawings and the implementation, as shown in fig. 1, a schematic structural diagram of an integrated pulse and cryoablation machine of the utility model is provided, wherein the integrated pulse and cryoablation machine comprises a handle 1, a push rod 2, a double-bending control handle 3, a catheter main body 4, a catheter bending section 5, a balloon 6, a balloon distal end 7, a catheter tail end 8, a socket anode 9, a socket cathode 10, a connecting cable 11, a refrigerant medium transmission pipe 12, a wave detection device 13 and a pulse and cryoablation generator 14.

The bidirectional deflection of the adjustable bending section 5 of the catheter is realized through the double-bending control handle 3 on the control handle 1. The push rod 2 is used for withdrawing the push rod when the saccule is inflated and pushing the push rod forwards when the saccule is deflated; preventing rupture of the balloon. The push rod is of a hollow structure, and a guide wire runs inside the push rod. The catheter main body 4 enters a human body in most of the length, and the outer side of the catheter main body is made of medical high polymer materials and bears all internal conducting wires and sensor wires; the saccule 6 has an inner layer and an outer layer, and the outer layer is directly contacted with the myocardial tissue; the far end 7 of the saccule is fixed on the inner tube by turning over, and the length of the far end is less than or equal to 0.5 mm. The electrodes at the end 8 of the catheter are connected to an anode socket 9 and a cathode socket 10, respectively, so that the anode and cathode can be separated, the pulse ablation is safer, and the catheter is connected to a pulse and freezing generator 14 through a connecting tail wire 11.

When the pulse discharges, only the detector 13 detects the R wave to discharge; when in cryoablation, an operator can select cryoablation, and a pulse and cryogenerator 14 provides nitrous oxide or nitrogen which is transmitted to the balloon catheter through a refrigeration medium transmission pipe 12 to enable the surface temperature of the balloon 6 to be lower than minus 45 ℃; the pulse and cryo generator 14 has both pulse and cryoablation functions, with selective pulsing and cryo-ablation at the interface.

Referring to fig. 2, fig. 2 is a schematic cross-sectional view of fig. 1A-a. Fig. 2 is a schematic sectional structure view of an adjustable bent section a-a of the catheter, which comprises a multi-cavity tube 15, an inner tube 16, a vacuum pumping cavity 17, a pull wire cavity 18, a bend control pull wire 19, a catheter tail end 8, a refrigerant liquid inlet tube 21, a freezing balloon sensor wire 22 and a pulse ablation catheter wire 23. The multi-lumen tube 15 is made of a medical polymer material with good flexibility, softness and elasticity, for example: nylon (Pebax), polyester amine (TPU) and the like, the stay wire cavity 18 wraps the bending control stay wire 19 to prevent the bending control stay wire 19 from being folded or broken due to stress concentration, and the stay wire cavity 18 and the multi-cavity tube 15 are bonded together through hot melting or reflow welding to play roles in protecting the stay wire and reducing friction between the stay wire and the multi-cavity tube 15. Two bending control pull wires 19 respectively penetrate through two through holes of the multi-cavity tube 15 and are connected to the control end of the handle 1, and the two-way deflection of the adjustable bending section 5 of the catheter is realized through the control handle 3. The inner tube 16 is a hollow structure, the inside of the inner tube can pass through the catheter end 8, the outer tube of the catheter end 8 can be a stainless steel tube (with insulated inner surface) or a non-metal tube, and a conducting wire 23 is arranged inside the inner tube, and the conducting wire 23 can emit pulse energy and map intracardiac signals; the liquid inlet pipe 21 is used for conveying a refrigerating medium, and a plurality of small holes are formed in the far end of the liquid inlet pipe.

The ring electrode lead, the electromagnetic positioning sensor wire, the temperature sensor wire and the liquid alarm wire 22 can extract and transmit electrocardiosignals, establish the function of a three-dimensional heart model, transmit the temperature of the center or the surface of the balloon, alarm the risk in the balloon and the like.

Fig. 3 is an enlarged schematic view of balloon segment B. It includes an integrated catheter tip 8 for pulsatile ablation and mapping that passes through the middle of an inner tube 16 with a gap between them through which saline or contrast agents can pass. The outer balloon 24 is made of a high polymer material such as TPU or Pebax and is in direct contact with the myocardial tissue; the inner balloon 25 is made of a polymer material such as PET or TPU; the inner balloon 24 and the outer balloon 25 are bonded with the balloon far end 7 by glue or are welded by heat through reverse folding, so that the length of the balloon far end section can be reduced, and the ablation of the tail end 8 of the catheter and the extraction of intracardiac signals are facilitated; the proximal ends of the inner and outer balloons 24 and 25 are joined to the multi-lumen tube 15 by heat welding, which may be heat welding or laser welding, etc., to minimize the heat affected zone 27; the liquid inlet pipe 28 is a hollow structure, the outer diameter of the liquid inlet pipe is 0.2-1.0mm, the inner diameter of the liquid inlet pipe is 0.19-0.80mm, the far end of the liquid inlet pipe is of a spiral structure, 4-12 micropores are formed in the far end of the liquid inlet pipe, the liquid inlet pipe is distributed at an angle of 30-90 degrees, the pore diameter of the liquid inlet pipe is 0.01-0.2mm, a refrigerant is filled in the liquid inlet pipe, and the surface temperature of the balloon is reduced to be lower than minus 30 ℃ through gasification of the jet holes 29 or heat absorption by heat transfer, so that the purpose of treatment is achieved; and the temperature sensor 30 can accurately test the central temperature in the balloon, and the temperature in the balloon is an isothermal field generally. The sensor 31 in the saccule is used for giving an alarm to stop working when the saccule is damaged by external force or other reasons, so that the injury of a patient is reduced to the minimum. One embodiment of the sensor 31 in the balloon is a resistance unit that encounters a change in the resistance of the fluid, which causes a change in the resistance to trigger a sensor alarm when the balloon is damaged and bodily fluids enter the interior of the balloon.

Fig. 4 is an enlarged schematic view of the catheter tip. Multiple sets of electrodes 36 are provided on the catheter tip 8 to simultaneously achieve the functions of a catheter for impulse ablation and mapping. In the working state, the catheter is attached to the balloon 6, the balloon is attached to the pulmonary vein 38, 2-20 electrodes are arranged at the tail end 8 of the catheter, the length of each electrode is 1-6mm, and the outer diameter of each electrode is 0.5-5 mm. It is connected with the stay wire or the safety wire, and plays the role of protecting and scratching the myocardial wall. The tail end 8 of the catheter is folded and attached to the surface of the balloon, and has a deflection angle of 5-45 degrees, so that the catheter is better attached to the surface of the balloon, and the attachment is better.

Fig. 5 is a schematic view of a distal end use state of the balloon. The tail end 8 of the catheter is provided with a plurality of groups of electrodes, the functions of pulse ablation and catheter mapping are realized simultaneously, and the catheter is attached to the balloon 6 in a working state, and the balloon is attached to the pulmonary vein 38, so that the extraction of the pulmonary vein potential is facilitated.

Fig. 6 is a flowchart of an ablation process. When the operator selects the ablation mode before starting the operation, the specific flow is shown in the attached figure 6: at the start of the procedure, the operator may select the procedure from the user interface of the pulse and freeze generator 14. When the cryoablation is selected, the cryoablation is realized by filling the cryoablation gas and the catheter inspection is mapped. When pulse ablation is selected, and R waves are detected, pulse ablation is started, and the potential is detected by the mapping catheter.

While embodiments of the utility model have been disclosed above, it is not intended to be limited to the uses set forth in the specification and examples. It can be applied to all kinds of fields suitable for the present invention. Additional modifications will readily occur to those skilled in the art. Therefore, the utility model is not to be limited to the specific details and illustrations shown and described herein, without departing from the general concept defined by the claims and their equivalents.

Claims

1. Pulse and cryoablation all-in-one, including pulse and freezing generator, connecting cable, refrigeration medium transmission pipe, pipe and sacculus, characterized by:

the pulse and freezing generator has two functions of pulse and cryoablation, and the interface of the pulse and freezing generator can be selected;

the connecting cable connects the pulse and freezing generator with the catheter to transmit pulse energy, and the refrigerant transmission pipe transmits the refrigerant generated by the pulse and freezing generator to the balloon;

the balloon surrounds the catheter, the tail end of the catheter extends out of the far end of the balloon and folds back to surround the outer surface of the balloon, and a plurality of groups of electrodes are arranged on the catheter and used as pulse electrodes to extract electrocardiosignals;

when pulse ablation is selected, discharging between the electrodes to realize pulse ablation; when cryoablation is selected, refrigerant is delivered to the distal end of the balloon to produce a freezing effect, and the electrodes extract electrocardiosignals.

2. The integrated pulsing and cryoablation machine of claim 1 further comprising a detector means connected to the pulse and cryogenerator, the detector means controlling the circuit to open and close when the pulses are discharged, the discharge being enabled only when the detector means detects the R wave.

3. The integrated machine of claim 1, wherein the pulse and cryoablation generator is connected to the electrodes via a positive socket and a negative socket, respectively, thereby separating the positive and negative electrodes and making the pulse ablation safer.

4. The machine of claim 1, wherein the balloon has an inner layer and an outer layer, the outer layer is in direct contact with the myocardial tissue, and both ends of the inner and outer balloons are connected with the catheter.

5. The machine of claim 4 wherein a sensor is positioned between the inner and outer layers of the balloon to sense pressure changes between the inner and outer layers.

6. The machine of claim 4 wherein the balloon has a sensor disposed therein, the sensor providing an alarm when the balloon is broken.

7. The machine of claim 4 wherein the outer balloon is positioned against the pulmonary vein during cryoablation and the folded back portion of the distal end of the catheter is positioned snugly around the outer balloon surface.

8. The integrated pulsing and cryoablation device of claim 1 wherein the catheter is a multi-lumen tube, the distal catheter portion is a bidirectionally deflectable, adjustable bend segment, and the electrode is located at the distal catheter end.

9. The integrated pulsing and cryoablation machine of claim 8 wherein at least two of the lumens of the catheter multilumen tube have bend-controlling wires connected to the control end of the handle for bi-directional deflection of the adjustable bend section of the catheter by the control handle.

10. The integrated pulsing and cryoablation machine of claim 9 wherein the bend-controlling pull wire is encased by the bend-controlling pull wire lumen to prevent the pull wire from stress concentration buckling or snapping.

11. The integrated pulsing and cryoablation machine of claim 10 wherein the bend-controlling puller wire lumen and the multi-lumen tube are bonded together by heat fusion or reflow to protect the puller wire and reduce friction between the puller wire and the multi-lumen tube.

12. The integrated pulsing and cryoablation machine of claim 1 wherein said catheter is a multi-lumen tube wherein at least one lumen is an evacuation lumen.

13. The integrated pulsing and cryoablation machine according to claim 1 wherein the catheter is a multi-lumen tube, at least one of the lumens being a coolant inlet tube, the coolant inlet tube carrying a coolant medium, the distal end of the tube having a helical configuration and being provided with a plurality of small holes.

14. The integrated pulsing and cryoablation machine of claim 1 wherein said catheter is a multi-lumen tube wherein at least one lumen contains a cryoballoon sensor wire.

15. The integrated pulsing and cryoablation machine according to claim 1 wherein the catheter is a multi-lumen tube wherein at least one lumen houses a pulsing ablation catheter wire.

16. The machine of claim 15, wherein the catheter wire is capable of transmitting pulse energy and mapping intracardiac signals.

17. The integrated pulsing and cryoablation machine of claim 15 wherein a gap exists between the pulsing ablation catheter wire and the cavity in which it is housed through which saline or contrast agent can pass.