An adjustable balloon size cryoballoon catheter

Abstract

The application discloses a cryoballoon catheter with adjustable balloon size, which comprises a handle unit, a balloon unit, an outer tube and an inner tube located in the outer tube; the distal end of the balloon unit is connected with the distal end of the inner tube, and the proximal end of the balloon unit is connected with the distal end of the outer tube; the handle unit comprises a shell, an adjusting unit and two limiting units. The cryoballoon catheter can first fill the proximal chamber to realize the preliminary positioning of the balloon, then fill the distal chamber to realize the occlusion of the pulmonary vein orifice. Moreover, the size of the balloon during filling can be adjusted according to the size of the pulmonary vein orifice of the patient, so that better occlusion is realized.

Description

Technical Field

[0001] This utility model relates to the field of cryoablation technology, and more specifically, to a cryoballoon catheter with adjustable balloon size. Background Technology

[0002] Cryoablation, also known as cryoablation, is a minimally invasive treatment technique that uses extremely low temperatures to destroy specific tissues, primarily used to treat cardiac arrhythmias. Cryoballoon ablation is a minimally invasive ablation technique that has gained considerable attention in recent years. It uses a balloon as a carrier to deliver cryotherapy to the target tissue (such as the atrial tissue around the pulmonary veins), achieving rapid and stable ablation damage, and is mainly used to treat atrial fibrillation.

[0003] Existing cryoballoon catheters, in practice, require an inflated balloon to occlude the pulmonary vein orifice. When occluding the pulmonary vein orifice with a balloon, it's often impossible to first roughly locate the orifice before occlusion, making the procedure difficult and potentially leading to occlusion failure. Furthermore, the size of the pulmonary vein orifice varies among patients; some have wider orifices than others. However, the balloons in existing cryoballoon catheters are not perfectly compatible with all these different sized pulmonary vein orifices. When the balloon and the pulmonary vein orifice are mismatched, poor occlusion results. Utility Model Content

[0004] The present invention aims to overcome the shortcomings of the prior art and provide a cryoballoon catheter with adjustable balloon size.

[0005] To achieve the above objectives, this utility model provides the following technical solution: a cryoballoon catheter, comprising a handle unit, a balloon unit, an outer tube, and an inner tube located within the outer tube; the distal end of the balloon unit is connected to the distal end of the inner tube, and the proximal end of the balloon unit is connected to the distal end of the outer tube; the handle unit comprises a housing, an adjustment unit, and two limiting units; the limiting unit comprises a connecting plate fixedly connected to the housing and a limiting tube fixedly connected to the connecting plate; the adjustment unit comprises a rack fixedly connected to the inner tube, two mounting plates fixedly connected to the housing, a rotating shaft mounted on the mounting plate, a gear mounted on the rotating shaft and engaging with the rack, a passive knob mounted on the rotating shaft, and a rotation adjustment knob mounted on the housing capable of driving the passive knob to rotate; the inner tube passes through the limiting tube and is slidable relative to the limiting tube.

[0006] Furthermore, the housing has a through groove, a fixed shaft is fixed in the through groove, and the rotary adjustment knob has a through hole through which the fixed shaft passes; elastic pads that can abut against the through groove are fixed on both sides of the rotary adjustment knob; both the passive knob and the rotary adjustment knob are cylindrical and have multiple protrusions distributed in annular intervals on their circumference.

[0007] This increases the damping effect, so that the adjustment knob will not turn when there is no external force.

[0008] Furthermore, an end plate is fixed to the end of the limiting tube, a guide rod is fixed between the end plates of the two limiting tubes, and the rack has a guide hole through which the guide rod passes.

[0009] This makes the rack movement more stable, thus enabling the inner tube to move stably.

[0010] Furthermore, an injection pipe and a recovery pipe are installed between the inner pipe and the outer pipe; the shell has a first connector and a second connector, the inner pipe is connected to the first connector, and the outer pipe is fixedly connected to the shell; both the injection pipe and the recovery pipe are connected to the second connector.

[0011] Furthermore, the balloon unit includes an outer balloon, an inner balloon located within the outer balloon, and a partition connecting the outer and inner balloons. The partition divides the space between the outer and inner balloons into a distal chamber and a proximal chamber. The outer tube has a first channel and a second channel. The proximal end of the first channel is connected to a first proximal connecting tube, and the distal end is connected to a first distal connecting tube. The first distal connecting tube passes through the inner balloon and communicates with the distal chamber. The distal end of the second channel communicates with the proximal chamber, and the proximal end is connected to a second proximal connecting tube. Both the first and second proximal connecting tubes are connected to a second connector.

[0012] Furthermore, a first temperature sensor located in the distal chamber, a first pressure sensor located in the distal chamber, a second temperature sensor located in the proximal chamber, and a second pressure sensor located in the proximal chamber are installed on the outer side of the inner balloon.

[0013] This allows for the detection of temperature and pressure in both the proximal and distal chambers.

[0014] Furthermore, the first connector has a first tube section connected to the inner tube; the second connector has a second tube section connected to the air injection tube, a third tube section connected to the recovery tube, a fourth tube section connected to the first proximal connecting tube, and a fifth tube section connected to the second proximal connecting tube.

[0015] Furthermore, a first valve is installed at the fourth pipe section; a second valve is installed at the fifth pipe section.

[0016] This allows for separate inflation of the proximal and distal chambers.

[0017] Beneficial effects:

[0018] 1. The cryoballoon catheter of this application can first inflate the proximal chamber to achieve preliminary positioning of the balloon, and then inflate the distal chamber to achieve occlusion of the pulmonary vein orifice.

[0019] 2. The cryoballoon catheter of this application can adjust the size of the balloon when inflated according to the size of the patient's pulmonary vein orifice, so as to achieve better occlusion. Attached Figure Description

[0020] Figure 1 This is a first-view schematic diagram of a cryoballoon catheter.

[0021] Figure 2 This is a schematic diagram of area A;

[0022] Figure 3 This is a schematic diagram of area B;

[0023] Figure 4 This is a schematic diagram of a cryoballoon catheter from a second perspective.

[0024] Figure 5 This is a schematic diagram of region C;

[0025] Figure 6 This is a schematic diagram of a cryoballoon catheter from a third-view perspective.

[0026] Figure 7 This is a schematic diagram of region D;

[0027] Figure 8 This is a schematic diagram of region E;

[0028] Figure 9 This is a schematic diagram of a cryoballoon catheter from a fourth-angle perspective.

[0029] Figure 10 This is a schematic diagram of region F;

[0030] Figure 11 This is a schematic diagram of region G;

[0031] Figure 12 This is a schematic diagram of a cryoballoon catheter from a fifth-angle perspective.

[0032] Figure 13 This is a sixth-angle view of a cryoballoon catheter.

[0033] For ease of illustration, Figure 4 — Figure 13 The handle unit and balloon unit were partially removed to reveal their internal structure.

[0034] Explanation of reference numerals in the attached drawings: Handle unit 1; Balloon unit 2; Outer balloon 2.1; Inner balloon 2.2; Divider 2.3; Outer tube 3; First channel 3.1; Second channel 3.2; First proximal connecting tube 3.3; First distal connecting tube 3.4; Second proximal connecting tube 3.5; Inner tube 4; Housing 5; First connector 5.1; Second connector 5.2; First tube section 5.3; Second tube section 5.4; Third tube section 5.5; Fourth tube section 5.6; Fifth tube section 5.7; Connecting plate 6.1; Limiting tube 6.2; End plate 6.3; Guide rod 6.4; Rack 7.1; Mounting plate 7.2; Rotating shaft 7.3; Gear 7.4; Passive button 7.5; Rotation adjustment button 7.6; Inflation tube 8; Recovery tube 9. Detailed Implementation

[0035] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0036] This utility model provides an adjustable balloon catheter, as shown in the figure, comprising a handle unit 1, a balloon unit 2, an outer tube 3, and an inner tube 4 located within the outer tube 3; the distal end of the balloon unit 2 is connected to the distal end of the inner tube 4, and the proximal end of the balloon unit 2 is connected to the distal end of the outer tube 3; the handle unit 1 includes a housing 5, an adjustment unit, and two limiting units; the limiting unit includes a connecting plate 6.1 fixedly connected to the housing 5 and a limiting tube 6.2 fixedly connected to the connecting plate 6.1; the adjustment unit includes a rack 7.1 fixedly connected to the inner tube 4, two mounting plates 7.2 fixedly connected to the housing 5, a rotating shaft 7.3 mounted on the mounting plate 7.2, a gear 7.4 mounted on the rotating shaft and engaging with the rack 7.1, a passive button 7.5 mounted on the rotating shaft, and a rotation adjustment knob 7.6 mounted on the housing 5 capable of driving the passive button 7.5 to rotate; the inner tube 4 passes through the limiting tube 6.2 and is slidable relative to the limiting tube 6.2.

[0037] The housing 5 has a through groove, and a fixed shaft is fixed in the through groove. The rotary adjustment knob 7.6 has a through hole through which the fixed shaft passes. Elastic pads that can abut against the through groove are fixed on both sides of the rotary adjustment knob 7.6. Both the passive knob 7.5 and the rotary adjustment knob 7.6 are cylindrical and have multiple annularly spaced protrusions on their circumference. An end plate 6.3 is fixed to the end of the limiting tube 6.2, and a guide rod 6.4 is fixed between the end plates 6.3 of the two limiting tubes 6.2. The rack 7.1 has a guide hole through which the guide rod 6.4 passes. An injection pipe 8 and a recovery pipe 9 are installed between the inner tube 4 and the outer tube 3. The housing 5 has a first connector 5.1 and a second connector 5.2. The inner tube 4 is connected to the first connector 5.1, and the outer tube 3 is fixedly connected to the housing 5. The injection pipe 8 and the recovery pipe 9 are both connected to the second connector 5.2.

[0038] The balloon unit 2 includes an outer balloon 2.1, an inner balloon 2.2 located inside the outer balloon 2.1, and a partition 2.3 connecting the outer balloon 2.1 and the inner balloon 2.2. The partition 2.3 divides the space between the outer balloon 2.1 and the inner balloon 2.2 into a distal chamber and a proximal chamber. The outer tube 3 has a first channel 3.1 and a second channel 3.2. The proximal end of the first channel 3.1 is connected to a first proximal connecting tube 3.3, and the distal end is connected to a first distal connecting tube 3.4. The first distal connecting tube 3.4 passes through the inner balloon 2.2 and communicates with the distal chamber. The distal end of the second channel 3.2 communicates with the proximal chamber, and the proximal end is connected to a second proximal connecting tube 3.5. Both the first proximal connecting tube 3.3 and the second proximal connecting tube 3.5 are connected to a second connector 5.2. The inner balloon 2.2 is equipped with a first temperature sensor located in the distal chamber, a first pressure sensor located in the distal chamber, a second temperature sensor located in the proximal chamber, and a second pressure sensor located in the proximal chamber. The first connector 5.1 has a first tube portion 5.3 connected to the inner tube 4; the second connector 5.2 has a second tube portion 5.4 connected to the inflation tube 8, a third tube portion 5.5 connected to the recovery tube 9, a fourth tube portion 5.6 connected to the first proximal connecting tube 3.3, and a fifth tube portion 5.7 connected to the second proximal connecting tube 3.5. A first valve is installed at the fourth tube portion 5.6; a second valve is installed at the fifth tube portion 5.7.

[0039] Working principle: In use, the balloon catheter of this application can be adjusted by rotating the adjustment knob to adjust the position of the distal end of the inner tube relative to the distal end of the outer tube, thereby adjusting the length of the balloon in the initial state, and thus adjusting the size of the balloon after inflation, thereby achieving adjustment of the balloon size before inflation.

[0040] The balloon catheter of this application, during inflation, first inflates the distal chamber using the first channel to achieve initial balloon positioning, and then inflates the proximal chamber using the second channel to achieve occlusion of the pulmonary vein orifice. Furthermore, it can monitor the temperature and pressure of the proximal and distal chambers, thereby controlling the amount of inflation medium injected (the balloon has a certain elasticity; by increasing the pressure of the inflation medium, the balloon can expand, thus allowing for fine-tuning of the balloon's inflation volume), thereby achieving appropriate inflation and better occlusion of the pulmonary vein orifice.

[0041] Although the present invention has been illustrated and described with reference to preferred embodiments, those skilled in the art should understand that various changes and modifications can be made to the present invention without departing from the scope defined by the claims.

Claims

1. A cryoballoon catheter with adjustable balloon size, characterized in that, The device includes a handle unit, a balloon unit, an outer tube, and an inner tube located within the outer tube. The distal end of the balloon unit is connected to the distal end of the inner tube, and the proximal end of the balloon unit is connected to the distal end of the outer tube. The handle unit includes a housing, an adjustment unit, and two limiting units. The limiting unit includes a connecting plate fixedly connected to the housing and a limiting tube fixedly connected to the connecting plate. The adjustment unit includes a rack fixedly connected to the inner tube, two mounting plates fixedly connected to the housing, a rotating shaft mounted on the mounting plate, a gear mounted on the rotating shaft and engaging with the rack, a passive button mounted on the rotating shaft, and a rotation adjustment knob mounted on the housing capable of driving the passive button to rotate. The inner tube passes through the limiting tube and can slide relative to the limiting tube.

2. The adjustable balloon size cryoballoon catheter according to claim 1, characterized in that, The housing has a through groove, and a fixed shaft is fixed in the through groove. The rotary adjustment knob has a through hole through which the fixed shaft passes. Both sides of the rotary adjustment knob are fixed with elastic pads that can abut against the through groove. Both the passive knob and the rotary adjustment knob are cylindrical and have multiple protrusions distributed in a ring at equal intervals on their circumference.

3. The adjustable balloon size cryoballoon catheter according to claim 2, characterized in that, An end plate is fixed to the end of the limiting tube, and a guide rod is fixed between the end plates of the two limiting tubes. The rack has a guide hole through which the guide rod passes.

4. The cryoballoon catheter with adjustable balloon size according to claim 1, characterized in that, An injection pipe and a recovery pipe are installed between the inner pipe and the outer pipe; the shell has a first connector and a second connector, the inner pipe is connected to the first connector, and the outer pipe is fixedly connected to the shell; both the injection pipe and the recovery pipe are connected to the second connector.

5. The cryoballoon catheter with adjustable balloon size according to claim 4, characterized in that, The balloon unit includes an outer balloon, an inner balloon located within the outer balloon, and a partition connecting the outer and inner balloons. The partition divides the space between the outer and inner balloons into a distal chamber and a proximal chamber. The outer tube has a first channel and a second channel. The proximal end of the first channel is connected to a first proximal connecting tube, and the distal end is connected to a first distal connecting tube. The first distal connecting tube passes through the inner balloon and communicates with the distal chamber. The distal end of the second channel communicates with the proximal chamber, and the proximal end is connected to a second proximal connecting tube. Both the first and second proximal connecting tubes are connected to a second connector.

6. The cryoballoon catheter with adjustable balloon size according to claim 5, characterized in that, The inner balloon is equipped with a first temperature sensor located in the distal chamber, a first pressure sensor located in the distal chamber, a second temperature sensor located in the proximal chamber, and a second pressure sensor located in the proximal chamber.

7. The adjustable balloon size cryoballoon catheter according to claim 5, characterized in that, The first connector has a first tube section that connects to the inner tube; the second connector has a second tube section that connects to the air injection tube, a third tube section that connects to the recovery tube, a fourth tube section that connects to the first proximal connecting tube, and a fifth tube section that connects to the second proximal connecting tube.

8. The cryoballoon catheter with adjustable balloon size according to claim 7, characterized in that, A first valve is installed at the fourth pipe section; a second valve is installed at the fifth pipe section.

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