CN109009407A - The cryoablation foley's tube and method of mapping function can be achieved - Google Patents

Abstract

The invention discloses a cryoablation balloon catheter and a method capable of realizing a mapping function, comprising a flexible catheter shaft unit, a balloon unit for abutting against the entrance of a pulmonary vein, a mapping unit and a conduction unit for detecting electrical signals of the pulmonary vein , the flexible catheter shaft unit includes an outer tube and an inner tube passing through the outer tube, the balloon unit is in the shape of a basket and includes a plurality of flexible strips that are evenly distributed circumferentially relative to the inner tube, two adjacent The flexible strips are distributed at intervals, the proximal end of each flexible strip is connected to the distal end of the outer tube, and the distal end is connected to the distal end of the inner tube, and the inner tube is along the axis of the outer tube Direction movement drives the flexible strips to be straightened or protruded, and a gap for deformation of the flexible strips is formed between the distal end of each flexible strip and the conduction unit. The present invention has at least the following advantages: high-density and high-precision mapping can be realized, and the success rate and monitoring rate of the mapping can be improved.

Description

Cryoablation balloon catheter and method capable of realizing mapping function

technical field

The invention relates to the technical field of medical devices, in particular to a cryoablation balloon catheter and a method capable of realizing a mapping function.

Background technique

Assembled ablation is used in many medical procedures to treat patients, and ablation can be performed to remove unwanted tissue, such as cancer cells, or can involve altering tissue without removing it. Ablation is often performed by delivering energy, such as electrical energy, through one or more electrodes, causing tissue to contact the electrodes to heat to the ablation temperature, but can also be performed using cryoablation catheters to freeze tissue.

While there are significant advantages to using balloons for cryoablation techniques, there are often associated disadvantages. First of all, the distal ends of the mapping catheters on the market are mostly ring-shaped structures. There are several mapping electrodes on the main ring structure of the mapping catheters. The electrical signals of the pulmonary veins are recorded through the mapping electrodes, and the pulmonary veins are often not a standard ring structure. This results in some mapping electrodes not making good contact with the vein and recording electrical signals. Secondly, when using a ring-shaped mapping catheter, it is necessary to extend the distal end of the mapping catheter beyond a certain length of the balloon, that is, the mapping electrode can only record electrical signals in the pulmonary vein, and the monitoring rate of the electrical signal inside the pulmonary vein is low, and the monitoring effect is low. Difference.

Contents of the invention

The technical problem to be solved by the present invention is to provide a cryoablation balloon catheter and method capable of realizing the mapping function, which can realize high-density and high-precision mapping, and improve the success rate and monitoring rate of the mapping.

In order to solve the above technical problems, the present invention provides a cryoablation balloon catheter that can realize the mapping function, including a flexible catheter shaft unit, a balloon unit arranged at one end of the flexible catheter shaft unit and used to abut the pulmonary vein inlet, A mapping unit arranged on the balloon unit for detecting pulmonary vein electrical signals and a conduction unit passing through the balloon unit, the flexible catheter shaft unit includes an outer tube and an inner tube passing through the outer tube, the Both the outer tube and the inner tube have a distal end and a proximal end, and the balloon unit is in the shape of a net basket and includes a plurality of flexible strips arranged evenly in the circumferential direction relative to the inner tube, and two adjacent flexible strips are arranged at intervals , the proximal end of each flexible strip is connected to the distal end of the outer tube, and the distal end is connected to the distal end of the inner tube, and the inner tube moves along the axial direction of the outer tube to drive the flexible strip The strips are straight or convex, and a gap for deformation of the flexible strips is formed between the distal end of each flexible strip and the conduction unit.

Further, the mapping unit includes a plurality of mapping electrodes arranged on the outer wall of the flexible strip, and wires connected to the mapping electrodes, and the mapping electrodes protrude relative to the flexible strip.

Further, the mapping electrodes are arranged at the distal end of the flexible strip, wherein at least one of the mapping electrodes is arranged at the outermost point of the bending of the flexible strip.

Further, the outer tube is provided with a wire duct for the wire to pass through.

Further, the conduction unit includes an inner balloon and an outer balloon sleeved on the inner balloon, and the outer balloon fits with the flexible strip.

Further, the outer tube is provided with a vacuum tube for vacuuming the gap formed between the inner balloon and the outer balloon.

Further, an injection tube is provided between the outer tube and the inner tube, and the distal end of the injection tube extends into the cavity of the inner balloon.

Further, a temperature sensor is provided inside the inner balloon, and the preset value of the temperature sensor is between minus 70°C and minus 40°C.

Further, both the outer tube and the inner tube are made of PEBAX or PA, and braided wires are embedded in the outer tube and the inner tube.

The invention also discloses a method capable of realizing the mapping function, which includes the following steps:

Step 1: The introduction of the cryoablation balloon catheter specifically includes: pushing the flexible strip to the ostium of the pulmonary vein. During this process, the inner tube is completely pushed out so that the flexible strip, the inner balloon, and the outer balloon are all It is in a stretched and restrained state; until the flexible strip runs to the pulmonary vein ostium, the inner tube is pulled back so that the flexible strip stretches to cover the pulmonary vein orifice;

Step 2: Filling with frozen gas, blocking the electrical conduction signal to achieve electrical isolation of the pulmonary vein ostium, specifically including: injecting frozen gas into the inner balloon through the injection tube, so that the inner balloon and the outer balloon are in the same shape. In the filling state, the flexible strip is completely attached to the pulmonary vein orifice, the mapping electrode records the electrical signal of the pulmonary vein orifice, the frozen gas is continuously injected into the inner balloon, and the temperature of the tissue at the pulmonary vein orifice is reduced through conduction, causing tissue necrosis. Until the electrical conduction signal at the pulmonary vein ostium is blocked.

By means of the above-mentioned technical solution, the present invention has at least the following advantages: by providing multiple flexible strips, each flexible strip can be well attached to the pulmonary vein orifice for pulmonary vein orifices of different shapes and sizes; the flexible long strips There is still a gap with the distal end of the outer balloon, which further improves the degree of freedom of the flexible strip, thereby improving the adhesion. The flexible strip is provided with a number of mapping electrodes, which can extract more electrical signals and achieve high density Mapping: The convex shape of the mapping electrodes is set to further improve the adhesion, thereby improving the success rate and accuracy of mapping.

Description of drawings

Fig. 1 is the overall structural representation of the present invention;

Fig. 2 is a schematic structural view of the balloon unit of the present invention;

Fig. 3 is a partial structural sectional view of the present invention.

In the above drawings: 1. Outer tube; 2. Inner tube; 3. Flexible strip; 4. Gap; 5. Mapping electrode; 6. Wire conduit; 7. Inner balloon; 8. Outer balloon; Vacuum pipeline; 10, injection tube.

Detailed ways

The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments, so that those skilled in the art can better understand the present invention and implement it, but the examples given are not intended to limit the present invention.

As shown in FIG. 1 to FIG. 3 , the present invention discloses a cryoablation balloon catheter that can realize the mapping function, including a flexible catheter shaft unit, a balloon arranged at one end of the flexible catheter shaft unit and used to abut against the entrance of the pulmonary vein The balloon unit, the mapping unit arranged on the balloon unit for detecting the electrical signal of the pulmonary vein, and the conduction unit passing through the balloon unit. In the present invention, the flexible catheter shaft unit includes an outer tube 1 and an inner tube 2 passing through the outer tube 1. Both the outer tube 1 and the inner tube 2 have a distal end and a proximal end, wherein the end near the balloon unit One side is the distal end, and the side away from the balloon unit is the proximal end. In the present invention, preferably, the outer tube 1 and the inner tube 2 are made of PEBAX or PA, and the outer tube 1 and the inner tube 2 are embedded with braided wires, which can effectively improve the bending resistance.

The balloon unit is in the shape of a net basket and includes a plurality of flexible strips 3 that are evenly distributed circumferentially relative to the inner tube, two adjacent flexible strips 3 are distributed at intervals, and each flexible strip 3 is nearly The end is connected to the far end of the outer tube 1, and the far end is connected to the far end of the inner tube 2, and the inner tube 2 moves along the axial direction of the outer tube 1 to drive the flexible strip 3 to straighten or convex state. By providing a plurality of flexible strips 3 , each flexible strip 3 can well adhere to the pulmonary vein orifice for pulmonary vein orifices of different shapes and sizes. A gap 4 for deformation of the flexible strip 3 is formed between the distal end of each flexible strip 3 and the conduction unit. Through the existence of the gap 4, the degree of freedom of the flexible strip 3 is further improved, thereby improving the adhesion. In the present invention, preferably, the flexible strips 3 are formed by cutting nickel-titanium pipes and heat-treated to shape them, and there are 10-12 groups of the flexible strips 3 .

In the present invention, the mapping unit includes a plurality of mapping electrodes 5 arranged on the outer wall of the flexible strip 3 and wires connected to the mapping electrodes 5, and the mapping electrodes 5 are opposite to the flexible strip 3. raised. The mapping electrodes 5 are arranged at the distal end of the flexible strip 3 , wherein at least one of the mapping electrodes 5 is arranged at the outermost point of the bending of the flexible strip 3 . By arranging several mapping electrodes 5 , more electric signals can be extracted to realize high-density mapping; the mapping electrodes 5 are arranged in a convex shape to further improve adhesion, thereby improving the success rate and accuracy of mapping. In the present invention, preferably, the outer tube 2 is provided with a wire conduit 6 for passing the wire. In the present invention, the mapping electrode 5 has a disc structure and is made of platinum iridium.

In the present invention, the conduction unit includes an inner balloon 7 and an outer balloon 8 sleeved on the inner balloon 7 , and the outer balloon 8 is in shape fit with the flexible strip 3 . In the present invention, preferably, the inner balloon 7 and the outer balloon 8 are made of PA or PEBAX or PU or PET. The outer tube 1 is provided with a vacuum tube 9 for vacuuming the gap formed between the inner balloon 7 and the outer balloon 8 . By vacuuming, the inner balloon 7 can be better attached to the outer balloon 8, which can effectively ensure a better conductivity. An injection tube 10 is arranged between the outer tube 1 and the inner tube 2 , and the distal end of the injection tube 10 extends into the cavity of the inner balloon 7 . A temperature sensor is arranged inside the inner balloon 7, and the preset value of the temperature sensor is between minus 70°C and minus 40°C.

The invention also discloses a method capable of realizing the mapping function, which includes the following steps:

Step 1: The introduction of the cryoablation balloon catheter specifically includes: pushing the flexible strip 3 to the ostium of the pulmonary vein. During this process, the inner tube 2 is completely pushed out, so that the flexible strip 3, the inner balloon 7, The outer balloon 8 is stretched and restrained; until the flexible strip 3 runs to the pulmonary vein ostium, the inner tube 2 is pulled back, so that the flexible strip 3 stretches to cover the pulmonary vein orifice;

Step 2: Filling with refrigerated gas, blocking electrical conduction signals to achieve electrical isolation of the pulmonary vein ostium, specifically including: injecting refrigerated gas into the inner balloon 7 through the injection tube 10, so that the inner balloon 7 and the outer balloon 7 The balloon 8 is inflated, and then the flexible strip 3 is completely attached to the pulmonary vein ostium. The mapping electrode 5 records the electrical signal of the pulmonary vein ostium, and the frozen gas is continuously injected into the inner balloon 7 to lower the pulmonary vein ostium through conduction. Tissue temperature, causing tissue necrosis, until the electrical conduction signal at the pulmonary vein ostium is blocked.

The above-mentioned embodiments are only preferred embodiments for fully illustrating the present invention, and the protection scope of the present invention is not limited thereto. Equivalent substitutions or transformations made by those skilled in the art on the basis of the present invention are all within the protection scope of the present invention. The protection scope of the present invention shall be determined by the claims.

Claims (10)

1. a kind of cryoablation foley's tube of achievable mapping function, which is characterized in that including flexible conduit axle unit, setting In flexible conduit axle unit one end and it is used to abut the balloon units of pulmonary vein entrance, setting on balloon units for examining It surveys the mapping unit of pulmonary vein electric signal and wears the conduction unit of the balloon units, the flexible conduit axle unit includes outer Manage and wear the inner tube of the outer tube, the outer tube and inner tube all have proximally and distally, the balloon units in mesh basket shape and Including the more flexible strips that opposite said inner tube is circumferentially uniformly arranged, the two neighboring flexible strip is spaced apart, and every The proximal end of the flexible strip connects the distal end of the distal end of the outer tube, distal end connection said inner tube, and said inner tube is along described outer The axis direction movement of pipe is to drive the flexible strip in stretching or evagination state, distal end and the institute of the every flexible strip It states and forms a gap for flexible strip deformation between conduction unit.

2. the cryoablation foley's tube of achievable mapping function as described in claim 1, which is characterized in that the mapping list Member includes the conducting wire of the multiple mapping electrodes being arranged on the flexible strip outer wall, the connection mapping electrodes, the mapping electricity The extremely relatively described flexible strip protrusion.

3. the cryoablation foley's tube of achievable mapping function as claimed in claim 2, which is characterized in that the mapping electricity The distal end of the flexible strip is arranged in pole, and the setting of mapping electrodes described in wherein at least one is curved most in the flexible strip At exterior point.

4. the cryoablation foley's tube of achievable mapping function as claimed in claim 2, which is characterized in that on the outer tube Offer the wire duct worn for the conducting wire.

5. the cryoablation foley's tube of achievable mapping function as described in claim 1, which is characterized in that the conduction is single Member includes the outer sacculus of interior sacculus, the socket interior sacculus, and the outer sacculus and the flexible strip shape cooperate.

6. the cryoablation foley's tube of achievable mapping function as claimed in claim 5, which is characterized in that on the outer tube Offer the vacuum pipe that the gap for being formed between internal sacculus and outer sacculus is vacuumized.

7. the cryoablation foley's tube of achievable mapping function as claimed in claim 5, which is characterized in that the outer tube with Injection-tube is provided between inner tube, the distal end of the injection-tube is protruded into the cavity of the interior sacculus.

8. the cryoablation foley's tube of achievable mapping function as claimed in claim 5, which is characterized in that the interior sacculus It is inside provided with temperature sensor, the default value of the temperature sensor is at subzero 70 DEG C to subzero 40 DEG C.

9. the cryoablation foley's tube of achievable mapping function as described in claim 1, which is characterized in that the outer tube and Inner tube is all made of PEBAX or PA material, and is embedded with braided wires in the outer tube and inner tube.

10. a kind of method of achievable mapping function, based on the cold of the described in any item achievable mapping functions of claim 1-9 Freeze ablation foley's tube, which comprises the following steps:

Step 1: the introducing of cryoablation foley's tube specifically includes: flexible strip is pushed at orifices of pulmonary veins, this process In, completely out said inner tube, so that the flexible strip, interior sacculus, outer sacculus are to stretch restrained condition；Until flexible long Item is run to orifices of pulmonary veins, said inner tube of pulling back, so that the flexible strip, which is unfolded, pastes orifices of pulmonary veins；

Step 2: filling frozen gas blocks electrical conduction signal to realize the electric isolution of orifices of pulmonary veins, specifically includes: by described Injection-tube is to the interior ball intracapsular injection frozen gas, so that the interior sacculus and outer sacculus are in expanded state, and then will be flexible Strip reclines completely with orifices of pulmonary veins, and the electric signal of the mapping electrodes record orifices of pulmonary veins, the frozen gas persistently injects Interior sacculus reduces tissue temperature at orifices of pulmonary veins by conduction, causes tissue necrosis, until blocking the electrical conduction at orifices of pulmonary veins Signal.