CN116965909B - Double-layer balloon catheter for cryoablation based on novel inflation mode - Google Patents

Abstract

The application discloses a double-layer balloon catheter for cryoablation based on a novel inflation mode, which comprises an inner catheter, an outer catheter, an inner balloon, an outer balloon and an injection tube, wherein the inner catheter is connected with the outer balloon; a first pipe part is fixedly arranged between the inner pipe and the outer pipe, and comprises a first pipe body, a first front end plate fixedly connected with the first pipe body and a first rear end plate fixedly connected with the first pipe body; a second pipe part is fixedly arranged between the inner pipe and the outer pipe, and a communicating pipe is connected between the first pipe body and the second pipe body. The outer conduit is provided with a gas injection nozzle unit capable of injecting gas into the first conduit. The double-layer balloon catheter for cryoablation avoids cooling in the initial stage of inflation, ensures the adhesion of the inner-layer balloon and the outer-layer balloon in the freezing process, and has good cryoablation effect.

Description

Double-layer balloon catheter for cryoablation based on novel inflation mode

Technical Field

The application relates to a medical instrument, belongs to the technical field of pulmonary vein ablation surgery, and in particular relates to a double-layer balloon catheter for cryoablation based on a novel inflation mode.

Background

Through research, atrial fibrillation in most cases is triggered from within or near the pulmonary veins, and a recognized strategy to treat atrial fibrillation is pulmonary vein electrical isolation, which can be achieved through ablation procedures. The conventional ablation technology can be divided into radiofrequency ablation and cryoablation; the principle of radio frequency ablation is that under the action of an alternating current electric field formed by radio frequency, heat energy is generated to raise the temperature of target tissues and coagulative necrosis occurs; the principle of cryoablation is that the temperature of target cell tissues is reduced by taking away heat through the endothermic evaporation of liquid refrigerant, and the target cell tissues are damaged by freezing. The traditional radio frequency catheter ablation technique is often complicated to operate, long in time consumption and high in risk, and the cryoballoon ablation technique has the advantages of being small in pain of a patient, low in recurrence rate, safer, simpler and more convenient to operate and effective for doctors, and becomes an important mode for treating atrial fibrillation.

The following problems also exist with current cryoballoon catheters: in order to fill the balloon, in order to avoid overlarge balloon pressure caused by overlarge inflation, the inflation condition of the balloon needs to be monitored, so that the inflation device is controlled to adjust the inflation according to the condition, the operation flow is complicated, the operation time is longer, in addition, if the inflation is started, the refrigerant is used for inflation, the initial stage of inflation can generate cooling and freezing, and although the cooling effect is not continuous, the unnecessary temperature reduction person can still possibly damage human bodies; in order to ensure the temperature transmission effect, the inner layer balloon and the outer layer balloon of the double-layer balloon need to be vacuumized, an air suction channel is usually arranged in the catheter, the joint of the air suction channel and the catheter has the problem of poor sealing performance, the vacuum layer leaks air, and in addition, the double-layer balloon needs to be vacuumized in the operation, so that additional operation time is required; a series of inflation and air extraction operations lead to more complex operation and longer operation time.

Disclosure of Invention

The application aims to: the application aims to overcome the defects of the prior art and provides a double-layer balloon catheter for cryoablation based on a novel inflation mode.

The technical scheme is as follows: the double-layer balloon catheter for cryoablation comprises an inner catheter, an outer catheter, an inner balloon, an outer balloon and an injection tube positioned between the inner catheter and the outer catheter, wherein the front end of the inner balloon and the front end of the outer balloon are connected with the front end of the inner catheter, and the rear end of the inner balloon and the rear end of the outer balloon are connected with the front end of the outer catheter; the inner catheter and the outer catheter are fixedly provided with a first pipe part, the first pipe part comprises a first pipe body, a first front end plate fixedly connected with the first pipe body and a first rear end plate fixedly connected with the first pipe body, the first front end plate is provided with a first through hole communicated with the inner space of the inner balloon, the first rear end plate is provided with a second through hole, a circular ring part is fixedly arranged in the first pipe body, the circular ring part is connected with a pressing plate through a first spring, a sealing gasket capable of sealing the first through hole is fixedly arranged at the pressing plate, a sealing ring is fixedly arranged at the second through hole, the sealing ring is penetrated by a movable column, the movable column can displace relative to the sealing ring and is sealed between the movable column and the sealing ring, a first pull rope penetrating through the circular ring part is connected between the pressing plate and the front end of the movable column, and the rear end of the movable column is connected with a second pull rope; the outer conduit is provided with a gas injection nozzle unit capable of injecting gas into the first conduit.

Further, the gas injection nozzle unit can be used for gas extraction.

Further, a second pipe part is fixedly arranged between the inner pipe and the outer pipe, the second pipe part comprises a second pipe body, a second front end plate fixedly connected with the second pipe body and a second rear end plate fixedly connected with the second pipe body, the second front end plate is connected with a first movable plate through a second spring, a first piston is fixedly arranged at the first movable plate, a space between the first piston and the second front end plate is a negative pressure space, a space between the inner layer balloon and the outer layer balloon is an interlayer space, a communication hole for communicating the negative pressure space and the interlayer space is formed at the outer pipe, and an air suction nozzle unit capable of sucking air from the negative pressure space is arranged at the outer pipe;

The communication hole connects the negative pressure space and the interlayer space, so that the interlayer space and the negative pressure space are vacuumized as much as possible through the suction nozzle unit.

Further, a second piston is arranged in the second pipe body, the second piston is connected with a second movable plate, the second movable plate is fixedly connected with a movable rod, a plurality of frustum-shaped elastic blocks distributed in a row are arranged at the movable rod, a perforation penetrated by the movable rod is arranged at the second rear end plate, the perforation is frustum-shaped, the frustum-shaped elastic blocks can penetrate through the perforation from the outside of the second pipe body to enter the inside of the second pipe body, and a vent hole is arranged at the second rear end plate; a communicating pipe is connected between the first pipe body and the second pipe body.

Thereby through the movable rod of second pipe portion, adjust and reduce the space size between the first of second pipe portion, the two pistons to can adjust the gas filling volume more in a flexible way, adapt to the patient more, avoid the sacculus to full excessively.

Further, a first hole part is formed in the first pipe body, a second hole part is formed in the second pipe body, a communicating pipe is connected between the first hole part and the second hole part, and the second hole part is positioned between the first piston and the second piston; the communicating pipe is an arc-shaped pipe.

The communicating pipe connects the first pipe portion and the second pipe portion internal space, and the first pipe portion and the second pipe portion are communicated with each other.

Further, the sealing ring is made of rubber materials, and the movable column is cylindrical.

The rubber material can better block the second through hole, has better sealing performance, has certain strength and is not easy to excessively deform.

Further, the movable rod is cylindrical; the frustum-shaped elastic blocks at the movable rod are distributed in a row at equal intervals.

Further, the frustum-shaped elastic block is made of a rubber material.

Further, the number of the frustum-shaped elastic blocks is more than or equal to 10.

Further, the movable rod is connected with a marking rope.

Further, the tail end of the marking rope is provided with scale marks.

The frustum-shaped elastic block can lock the movable rod, so that the position of the second piston is fixed, and the size of the inner space of the second pipe part can be adjusted; the marking rope more clearly and clearly records the specific position of the movable rod adjustment.

Further, the second through hole is provided with two sealing rings.

Thereby sealing the movable column from air leakage with the second through hole.

Further, the first pipe body of the first pipe part is fixedly connected with the inner pipe and the outer pipe; the second pipe body of the second pipe part is fixedly connected with the inner pipe and the outer pipe.

So that the first pipe portion and the second pipe portion are fixed more stably. .

Further, a recovery channel is formed between the outer conduit and the inner conduit; the injection tube comprises an input tube and an annular tube connected with the input tube, and a plurality of spray holes are formed in the annular tube.

The spray holes enable the refrigerant to be uniformly sprayed into the balloon, the temperature of the balloon is quickly reduced, and the recovery of cooling gas is facilitated.

Further, the inner side wall of the outer conduit is provided with a plurality of separation plates, and a threading channel is formed between each separation plate and the outer conduit.

Thereby centralizing the protection lead, the threading channel can also be used for threading the catheter and the like according to the requirement, and the flexibility of the device in use is increased.

Further, an electrode is printed on the outer surface of the outer balloon, and a wire of the electrode passes through the threading channel.

So that the balloon can be used for measurement of electrical signals.

The beneficial effects are that:

1) The first pipe part and the second pipe part are arranged in the catheter, so that gas can be pre-filled before operation (the pre-filled gas amount is the fixed amount of just filled saccule, so that the condition of over-inflation cannot occur), and the operation flow is simpler and more convenient;

2) Through setting up the movable column, the clamp plate is connected to the movable column, through pulling the second stay cord that is connected with the movable column, pulls open the clamp plate, can release gas from first through-hole and get into the sacculus and make the sacculus full of fast, convenient and fast to shorten operation time greatly;

3) The vacuum suction nozzle unit is provided with a communication hole, so that the vacuum suction nozzle unit can be used for vacuumizing the interlayer space of the double-layer balloon in advance before the balloon catheter is used, an air suction channel is not required to be arranged in the catheter, and the sealing performance is better; the first piston is pushed under the action of the negative pressure space, and the interlayer space of the double-layer balloon can be pumped again while the first tube part and the second tube part are released to be filled with gas, so that the vacuum effect of the interlayer space is further enhanced;

4) Through setting up the movable rod at second pipe portion, through gas injection mouth unit (gas injection mouth unit also can be used to bleed) bleed to first pipe portion and second pipe portion gas space compression, because second back end plate department has the air vent, the air vent is connected with the atmospheric pressure, thereby the movable rod is promoted, thereby promote the interior space that the second piston dwindles second pipe portion, thereby adaptable different patients, the regulation gas fills total amount, avoids the sacculus to fill excessively.

5) Because during primary filling, normal temperature gas (namely gas initially positioned between the two pistons of the first pipe body and the second pipe body) is used, the temperature is prevented from being reduced when the temperature is not required to be reduced, and normal tissues of a human body are protected more.

Drawings

FIG. 1 is an overall schematic of a balloon catheter;

FIG. 2 is an enlarged view of area A;

FIG. 3 is a schematic view of the internal structure of the balloon catheter at a first view angle;

FIG. 4 is an enlarged view of the region B1;

FIG. 5 is an enlarged view of the region B2;

FIG. 6 is an enlarged view of region B3;

FIG. 7 is an enlarged view of the region B4;

FIG. 8 is a schematic view of the internal structure of the balloon catheter at a second perspective;

fig. 9 is an enlarged view of region C.

Detailed Description

Reference numerals: 1 an inner catheter; 2 an outer catheter; 2.1 an air injection nozzle unit; 2.2 an air extraction nozzle unit; 2.3 communicating holes;

3, a first pipe body; 3.1 a first front end plate; 3.1.1 first vias; 3.2 a first rear end plate; 3.2.1 sealing rings; 3.2.2 active columns; 3.3 a first pull rope; 3.4 a second pull rope; 3.5 a first spring; 3.6 pressing plates; 3.7 sealing gaskets; 3.8 first hole portions; 3.9 communicating pipe;

4, a second pipe body; 4.1 a second front end plate; 4.2 a second rear end plate; 4.2.1 vent holes; 4.3 a second spring; 4.4 a first movable plate; 4.4.1 first pistons; 4.5 a second movable plate; 4.5.1 second pistons; 4.5.2 moving rod; 4.5.3 the frustum shape has high elasticity; 4.5.4 marking the rope; 4.6 second hole portions;

5 an inner layer balloon; 6, outer layer sacculus; 7, injecting a tube; 7.1 an input tube; 7.2 a circular tube; 7.2.1 orifices.

As shown in the figure: the novel inflation mode-based double-layer balloon catheter for cryoablation comprises an inner catheter 1, an outer catheter 2, an inner balloon 5, an outer balloon 6 and an injection tube 7 positioned between the inner catheter 1 and the outer catheter 2, wherein the front end of the inner balloon 5 and the front end of the outer balloon 6 are connected with the front end of the inner catheter 1, and the rear end of the inner balloon 5 and the rear end of the outer balloon 6 are connected with the front end of the outer catheter 2; the inner catheter 1 and the outer catheter 2 are fixedly provided with a first pipe part, the first pipe part comprises a first pipe body 3, a first front end plate 3.1 fixedly connected with the first pipe body 3 and a first rear end plate 3.2 fixedly connected with the first pipe body 3, the first front end plate 3.1 is provided with a first through hole 3.1.1 communicated with the inner space of the inner balloon 5, the first rear end plate 3.2 is provided with a second through hole, the first pipe body 3 is internally fixed with a circular ring part, the circular ring part is connected with a pressing plate 3.6 through a first spring 3.5, the pressing plate 3.6 is fixedly provided with a sealing gasket 3.7 capable of sealing the first through hole 3.1.1, the second through hole is fixedly provided with a sealing ring 3.2.1, the second through hole is provided with two sealing rings 3.2.1, and the sealing ring 3.2.1 is made of rubber materials. The sealing ring 3.2.1 is penetrated by the movable column 3.2.2, the movable column 3.2.2 is cylindrical, the movable column 3.2.2 can displace relative to the sealing ring 3.2.1, the movable column 3.2.2 is sealed with the sealing ring 3.2.1, a first pull rope 3.3 penetrating through the circular ring part is connected between the pressing plate 3.6 and the front end of the movable column 3.2.2, and the rear end of the movable column 3.2.2 is connected with a second pull rope 3.4; the outer conduit 2 is provided with a gas injection nozzle unit 2.1 capable of injecting gas into the first conduit body 3.

A second pipe part is fixedly arranged between the inner pipe 1 and the outer pipe 2, the second pipe part comprises a second pipe body 4, a second front end plate 4.1 fixedly connected with the second pipe body 4 and a second rear end plate 4.2 fixedly connected with the second pipe body 4, the second front end plate 4.1 is connected with a first movable plate 4.4 through a second spring 4.3, a first piston 4.4.1 is fixedly arranged at the first movable plate 4.4, the space between the first piston 4.4.1 and the second front end plate 4.1 is a negative pressure space, the space between the inner layer balloon 5 and the outer layer balloon 6 is an interlayer space, a communication hole 2.3 for communicating the negative pressure space and the interlayer space is arranged at the outer pipe 2, and an air suction nozzle unit 2.2 capable of sucking air from the negative pressure space is arranged at the outer pipe 2; the second pipe body 4 is internally provided with a second piston 4.5.1, the second piston 4.5.1 is connected with a second movable plate 4.5, the second movable plate 4.5 is fixedly connected with a movable rod 4.5.2, and the movable rod 4.5.2 is cylindrical; the movable rod 4.5.2 is provided with a plurality of frustum-shaped elastic blocks 4.5.3 distributed in a row, and the plurality of frustum-shaped elastic blocks 4.5.3 at the movable rod 4.5.2 are distributed in a row at equal intervals; the frustum-shaped elastic block 4.5.3 is made of rubber materials; the number of the frustum-shaped elastic blocks 4.5.3 is more than or equal to 10; the movable rod 4.5.2 is connected with a marking rope 4.5.4; the end of the marking rope 4.5.4 is provided with scale marks. The second rear end plate 4.2 is provided with a perforation penetrated by the movable rod 4.5.2, the perforation is in a frustum shape, the frustum-shaped elastic block 4.5.3 can penetrate through the perforation from the outside of the second pipe body 4 to enter the inside of the second pipe body 4, and the second rear end plate 4.2 is provided with a vent hole 4.2.1; a communicating pipe 3.9 is connected between the first pipe body 3 and the second pipe body 4.

The first pipe body 3 of the first pipe part is fixedly connected with the inner pipe 1 and the outer pipe 2; the second pipe body 4 of the second pipe part is fixedly connected with the inner pipe 1 and the outer pipe 2. The first pipe body 3 is provided with a first hole part 3.8, the second pipe body 4 is provided with a second hole part 4.6, a communicating pipe 3.9 is connected between the first hole part 3.8 and the second hole part 4.6, and the second hole part 4.6 is positioned between the first piston 4.4.1 and the second piston 4.5.1; the communicating pipe 3.9 is an arc pipe. A recovery channel is formed between the outer conduit 2 and the inner conduit 1; the injection tube 7 comprises an input tube 7.1 and an annular tube 7.2 connected with the input tube 7.1, wherein a plurality of spray holes 7.2.1 are formed in the annular tube 7.2. The inner side wall of the outer guide tube 2 is provided with a plurality of separation plates, and a threading channel is formed between each separation plate and the outer guide tube 2. The outer surface of the outer balloon 6 is printed with an electrode, and a wire of the electrode passes through the threading channel.

As shown in the figure, the double-layer balloon catheter for cryoablation provides a novel inflation mode, so that the operation is more convenient. Before an operation, the first pipe part and the second pipe part in the catheter are pre-inflated by the air injection nozzle unit, and the pre-inflated air quantity is the fixed quantity of just inflated saccule, so that the condition of over inflation can not occur; in operation, the second stay rope connected with the movable column is pulled, so that the pressing plate connected with the movable column is pulled, and gas can be released from the first through hole to enter the balloon after pulling, so that the balloon is filled rapidly, the operation is convenient and quick, and the operation time is shortened greatly; after the balloon is filled, the complete plugging is confirmed, the refrigerant is injected through the injection tube, and the balloon is rapidly and uniformly injected through a plurality of spray holes of the annular tube, so that the balloon is rapidly cooled, and the target tissue is cryoablation is performed.

Through setting up intercommunicating pore connection negative pressure space and intermediate layer space to can be before the sacculus pipe uses the intermediate layer space evacuation of double-deck sacculus in advance through the air suction nozzle unit, and because the effect in negative pressure space, first piston is promoted, when pulling stay cord release first pipe portion and the gaseous filling sacculus of second pipe portion, because the atmospheric pressure between first, two pistons diminishes, under the effect of second spring, first piston can move down, the atmospheric pressure in negative pressure space further diminishes, thereby can bleed to the intermediate layer space of double-deck sacculus again, further strengthen the vacuum effect in intermediate layer space.

In addition, the second tube part is provided with a movable rod, before operation preparation, air is pumped through an air injection nozzle unit (the air injection nozzle unit can also be used for pumping air), the air pressure between the first piston part and the second piston part is reduced, and as the second rear end plate is provided with an air hole, the air hole is connected with the atmospheric pressure, under the action of the external atmospheric pressure, the movable rod is pushed, so that the second piston is pushed to reduce the inner space of the second tube part, thus being suitable for different patients, adjusting the total air filling amount (the initial air filling amount can be adjusted under the condition of keeping the air pressure in the first tube part and the second tube part constant) and avoiding the excessive filling of the sacculus; the frustum-shaped elastic block can lock the movable rod, so that the second piston position is fixed; and the movable rod is connected with a marking rope with scale marks, so that the specific position of the movable rod can be recorded more clearly and clearly.

While the invention has been shown and described with respect to the preferred embodiments, it will be understood by those skilled in the art that various changes and modifications may be made therein without departing from the scope of the invention as defined in the following claims.

Claims (6)

1. The double-layer balloon catheter for cryoablation based on the inflation mode is characterized by comprising an inner catheter, an outer catheter, an inner balloon, an outer balloon and an injection tube positioned between the inner catheter and the outer catheter, wherein the front end of the inner balloon and the front end of the outer balloon are connected with the front end of the inner catheter, and the rear end of the inner balloon and the rear end of the outer balloon are connected with the front end of the outer catheter; the inner catheter and the outer catheter are fixedly provided with a first pipe part, the first pipe part comprises a first pipe body, a first front end plate fixedly connected with the first pipe body and a first rear end plate fixedly connected with the first pipe body, the first front end plate is provided with a first through hole communicated with the inner space of the inner balloon, the first rear end plate is provided with a second through hole, a circular ring part is fixedly arranged in the first pipe body, the circular ring part is connected with a pressing plate through a first spring, a sealing gasket capable of sealing the first through hole is fixedly arranged at the pressing plate, a sealing ring is fixedly arranged at the second through hole, the sealing ring is penetrated by a movable column, the movable column can displace relative to the sealing ring and is sealed between the movable column and the sealing ring, a first pull rope penetrating through the circular ring part is connected between the pressing plate and the front end of the movable column, and the rear end of the movable column is connected with a second pull rope; the outer guide pipe is provided with a gas injection nozzle unit capable of injecting gas into the first pipe body; the device comprises an inner catheter and an outer catheter, wherein a second pipe part is fixedly arranged between the inner catheter and the outer catheter, the second pipe part comprises a second pipe body, a second front end plate fixedly connected with the second pipe body and a second rear end plate fixedly connected with the second pipe body, the second front end plate is connected with a first movable plate through a second spring, a first piston is fixedly arranged at the first movable plate, a space between the first piston and the second front end plate is a negative pressure space, a space between the inner balloon and the outer balloon is an interlayer space, a communication hole for communicating the negative pressure space and the interlayer space is formed at the outer catheter, and an air suction nozzle unit capable of exhausting air from the negative pressure space is arranged at the outer catheter; the second pipe body is internally provided with a second piston, the second piston is connected with a second movable plate, the second movable plate is fixedly connected with a movable rod, a plurality of frustum-shaped elastic blocks distributed in a row are arranged at the movable rod, the second rear end plate is provided with a perforation penetrated by the movable rod, the perforation is frustum-shaped, the frustum-shaped elastic blocks can penetrate through the perforation from the outside of the second pipe body to enter the inside of the second pipe body, and the second rear end plate is provided with a vent hole; a communicating pipe is connected between the first pipe body and the second pipe body; the first pipe body is provided with a first hole part, the second pipe body is provided with a second hole part, a communicating pipe is connected between the first hole part and the second hole part, and the second hole part is positioned between the first piston and the second piston; the communicating pipe is an arc-shaped pipe; the first pipe body of the first pipe part is fixedly connected with the inner pipe and the outer pipe; the second pipe body of the second pipe part is fixedly connected with the inner pipe and the outer pipe; a recovery channel is formed between the outer conduit and the inner conduit; the injection tube comprises an input tube and an annular tube connected with the input tube, and a plurality of spray holes are formed in the annular tube.

2. The dual balloon catheter for inflatable cryoablation of claim 1 wherein said sealing ring is made of rubber material and said movable post is cylindrical.

3. The inflatable double-layer balloon catheter for cryoablation according to claim 1, wherein the movable rod is cylindrical; the frustum-shaped elastic blocks at the movable rod are distributed in a row at equal intervals; the frustum-shaped elastic block is made of rubber materials; the number of the frustum-shaped elastic blocks is more than or equal to 10; the movable rod is connected with a marking rope; the tail end of the marking rope is provided with scale marks.

4. The dual balloon catheter for inflatable cryoablation of claim 1 wherein said second port has two of said sealing rings.

5. The dual balloon catheter for inflatable cryoablation of claim 1 wherein a plurality of separation plates are provided at the inner side wall of the outer catheter, each separation plate and the outer catheter defining a threading channel therebetween.

6. The balloon catheter for inflatable cryoablation as recited in claim 5 wherein the outer surface of the outer balloon is printed with electrodes, the wires of the electrodes passing through the threading channel.