Balloon catheter and electrophysiology system

Abstract

The application provides a balloon catheter and an electrophysiological system, which comprises a catheter body, a balloon and a pressure measuring assembly; the balloon is sleeved on the catheter body; the pressure measuring assembly is arranged in the balloon and comprises a first protective tube, a pressure sensor and a wire; the first protective tube is fixed to the outer sidewall of the catheter body along the axial direction of the catheter body; the first protective tube comprises a first section and a second section connected to the distal end of the first section; the distal end of the second section is communicated with the inside of the balloon; the pressure sensor is arranged in the second section; one end of the wire is connected to the pressure sensor; the other end of the wire extends out of the proximal end of the first section; and at least the distal end part of the wire is arranged in the first protective tube in a suspended manner, so that the pressure sensor is kept suspended in the second section. In this way, the pressure sensor kept suspended is arranged in the balloon; the addition of the pressure sensor can realize real-time monitoring of the internal pressure of the balloon; and then the internal pressure of the balloon can be regulated according to the monitored pressure information, so that the internal pressure of the balloon can be kept stable.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a balloon catheter and electrophysiological system. Background Technology

[0002] Patients with atrial fibrillation have a high risk of stroke. During atrial fibrillation, the atria beat irregularly and rapidly, losing their contractile function. This makes it easy for blood to stagnate in the atria, forming blood clots. If these clots break off and travel through the arteries to the brain, a stroke occurs. Treatment can be achieved by applying energy to the pulmonary veins via an interventional catheter to ablate them, thereby isolating the pulmonary vein potential.

[0003] Cryoablation, based on anatomical considerations, utilizes the contact between a balloon and tissue for freezing, and is characterized by its disposable and continuous nature. Specifically, a cryoablation balloon catheter is used, with a balloon placed at the distal end and a freezing device connected to the proximal end. During the procedure, the surgeon percutaneously inserts the cryoablation balloon catheter into the heart chamber, reaching the pulmonary vein orifice, and inflates the balloon. The outer wall of the balloon is adjusted to contact the myocardial tissue, and then the inlet tube inside the cryoablation balloon catheter sprays cryogenic fluid directly onto the inner surface of the balloon. The cryogenic fluid rapidly vaporizes and absorbs heat due to the heat conduction from the myocardial temperature, cooling the myocardial tissue in contact with the balloon and causing cryoablation.

[0004] A cryoballoon catheter is injected with a certain amount of gas and kept inflated to adhere to or seal the target location. During the subsequent ablation process, a certain pressure is maintained inside the balloon until the ablation is complete. In current technology, it is impossible to measure and control the pressure inside the balloon during ablation. Changes in the internal pressure of the balloon can cause changes in its shape; and both excessively high and low internal pressure can affect the safety of the procedure. Summary of the Invention

[0005] The purpose of this invention is to provide a balloon catheter and electrophysiological system to solve one or more problems in the prior art.

[0006] To solve the above-mentioned technical problems, the present invention provides a balloon catheter, comprising:

[0007] Catheter body;

[0008] A balloon, fitted over the catheter body; and,

[0009] A pressure measurement assembly is disposed within the balloon. The pressure measurement assembly includes a first sheath, a pressure sensor, and a lead wire. The first sheath is fixed to the outer wall of the catheter body along the axial direction of the catheter body. The first sheath includes a first section and a second section connected to the distal end of the first section. The distal end of the second section communicates with the interior of the balloon. The pressure sensor is disposed within the second section. One end of the lead wire is connected to the pressure sensor, and the other end of the lead wire extends beyond the proximal end of the first section. At least the distal portion of the lead wire is suspended within the first sheath, so that the pressure sensor remains suspended within the second section.

[0010] Optionally, in the balloon catheter, the pressure measurement assembly further includes a filler, at least partially filling the first segment of the first sheath to define the position of the lead wire within the first segment of the first sheath, such that at least the distal portion of the lead wire is suspended in the first sheath.

[0011] Optionally, in the balloon catheter, the pressure measurement assembly further includes a heat shrink tubing, which is at least sleeved on the first segment of the first sheath and the catheter body corresponding to the first segment of the first sheath, to fix the first sheath to the catheter body.

[0012] Optionally, in the balloon catheter, the heat shrink tubing is only fitted onto the first segment and the catheter body corresponding to the first segment to fix the first segment to the catheter body.

[0013] Optionally, in the balloon catheter, the first segment is fixed to the outer wall of the catheter body, and the second segment has a degree of freedom relative to the catheter body.

[0014] Optionally, in the balloon catheter, the inner diameter of at least a portion of the first segment is smaller than the inner diameter of the second segment and matches the outer diameter of the wire, so that the wire is coaxially arranged with the first sheath inside the first sheath.

[0015] Optionally, in the balloon catheter, the pressure measurement assembly further includes a second sheath, which is fitted inside the first sheath and covers a portion of the lead wire. The filler fills the inside of the second sheath and the gap between the second sheath and the first sheath to define that the second sheath and the first sheath are coaxially arranged, thereby defining the position of the lead wire within the first sheath.

[0016] Optionally, in the balloon catheter, the distance between the filler and the pressure sensor is not less than 0.5 mm.

[0017] Optionally, in the balloon catheter, the filler is obtained by injecting adhesive from the proximal end of the first sheath and then curing it.

[0018] Optionally, in the balloon catheter, the first sheath is a polymer material sheath.

[0019] Optionally, in the balloon catheter, the catheter body includes an outer tube and an inner shaft disposed in the outer tube, the distal end of the inner shaft extends out of the outer tube, the balloon is sleeved on the inner shaft extending out of the outer tube, the distal end of the balloon is connected to the inner shaft, the proximal end of the balloon is connected to the outer tube, the pressure sensor is fixed to the outer wall of the inner shaft through the first protective tube, and the wire is arranged along the axial direction of the inner shaft.

[0020] The present invention also provides an electrophysiological system, characterized in that it includes a balloon catheter, an ablation energy output device, and a control device as described in any of the preceding claims, wherein the ablation energy output device is connected to the balloon catheter and is used to provide an ablation medium to the balloon catheter; the control device is used to control the ablation medium energy output device to adjust the output amount of the ablation medium according to the pressure information detected by the pressure sensor, so that the internal pressure of the balloon is within a target range.

[0021] In summary, the balloon catheter and electrophysiological system provided by the present invention include: a catheter body, a balloon, and a pressure measurement component; the balloon is fitted inside the catheter body; the pressure measurement component is disposed within the balloon, and the pressure measurement component includes a first sheath, a pressure sensor, and a lead wire. The first sheath is fixed to the outer wall of the catheter body along its axial direction; the first sheath includes a first segment and a second segment connected to the distal end of the first segment, the distal end of the second segment communicating with the interior of the balloon; the pressure sensor is disposed within the second segment; one end of the lead wire is connected to the pressure sensor, and the other end of the lead wire extends beyond the proximal end of the first segment, with at least the distal portion of the lead wire suspended within the first sheath, so that the pressure sensor remains suspended within the second segment. Compared with the prior art, the balloon catheter and electrophysiological system provided by the present invention have the following beneficial effects:

[0022] (1) A pressure sensor that keeps the balloon suspended is installed inside the balloon. The addition of this pressure sensor can monitor the pressure inside the balloon in real time throughout the process. The equipment system adjusts according to the obtained pressure information to keep the pressure inside the balloon stable. The stability of the pressure inside the balloon can fix the shape of the balloon and make the catheter perform better. On the other hand, it can also improve the safety of the whole process.

[0023] (2) Furthermore, the first protective tube used to house the pressure sensor is semi-fixed. The part of the first protective tube that houses the pressure sensor has a certain degree of freedom relative to the catheter body, which can avoid the influence of balloon contraction and inner shaft bending on the pressure sensor during actual use of the catheter.

[0024] (3) Furthermore, the proximal part of the first protective tube adopts a reduced diameter design. The reduced diameter part can better limit the pressure sensor wire to remain coaxial with the first protective tube inside the first protective tube, thereby further ensuring that the pressure sensor is suspended inside the first protective tube.

[0025] (4) Furthermore, in addition to the first protective tube that houses the pressure sensor, a second protective tube is also provided to cover part of the wires of the pressure sensor. By using the coaxial arrangement of the second protective tube and the first protective tube, the position of the wires in the first protective tube is limited, thereby further ensuring that the pressure sensor is suspended in the first protective tube. Attached Figure Description

[0026] Figure 1 A schematic diagram of an exemplary balloon catheter provided for an embodiment of the present invention;

[0027] Figure 2 This is a partial structural diagram of the balloon catheter in Embodiment 1 of the present invention;

[0028] Figure 3 A schematic diagram of cardiac ablation using an electrophysiological system provided in an embodiment of the present invention;

[0029] Figure 4 A schematic diagram of renal artery ablation using the electrophysiological system provided in an embodiment of the present invention;

[0030] Figure 5 This is a partial structural diagram of the balloon catheter in Embodiment 2 of the present invention;

[0031] Figure 6 This is a partial structural diagram of the balloon catheter in Embodiment 3 of the present invention;

[0032] Figure 7 This is a schematic diagram of the pressure sensing component in Embodiment 4 of the present invention;

[0033] The labels in the attached figures are explained as follows:

[0034] 1-Catheter body; 2-Pressure measurement assembly; 3-Balloon;

[0035] 11-Outer tube; 12-Inner shaft; 13-Handle; 14-Fluid delivery fitting; 15-Soft tip; 16-Developing mark;

[0036] 21-Pressure sensor; 22-First protective tube; 23-Fill body; 24-Wire; 25-Adhesive; 26-Heat shrink tubing; 27-Another heat shrink tubing; 28-Second protective tube;

[0037] 31-Inner balloon; 32-Outer balloon;

[0038] 131 - Electrical input / output interface; 132 - Fluid input interface; 133 - Internal cavity interface;

[0039] 141-Helical structure;

[0040] 100 - Balloon catheter; 200 - Ablation energy output device; 300 - Control device;

[0041] a - First paragraph; b - Second paragraph. Detailed Implementation

[0042] To make the objectives, advantages, and features of this invention clearer, the invention will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clearly illustrate the objectives of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and sometimes use different scales. It should also be understood that, unless specifically stated or indicated, the terms "first," "second," "third," etc., in the specification are only used to distinguish the various components, elements, steps, etc., in the specification, and are not used to indicate the logical or sequential relationships between the various components, elements, steps, etc.

[0043] In this application, "proximal" and "distal" refer to the relative orientation, position, and direction of the components or movements relative to each other from the perspective of the physician using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" usually refers to the end of the medical device that is closer to the physician during normal operation, while "distal" usually refers to the end that first enters the patient's body.

[0044] Example 1

[0045] Please see Figure 1 This embodiment provides a balloon catheter, including: a catheter body 1, a balloon 3 and a pressure measurement component 2. The balloon 3 is sleeved on the catheter body 1. Specifically, a portion of the catheter body 1 extends into the balloon 3 to provide an ablation medium into the balloon 3. The ablation medium includes, but is not limited to, cryo-liquid, and may also be cryo-gas, etc.

[0046] Please refer to the following for details. Figure 2 and combined Figure 1The pressure measurement assembly is disposed within the balloon 3. The pressure measurement assembly includes a pressure sensor 21, a first sheath 22, and a lead wire 24. The first sheath 22 is fixed to the outer wall of the catheter body 1 along the axial direction of the catheter body 1. The first sheath 22 includes a first segment a and a second segment b connected to the distal end of the first segment a. The pressure sensor 21 is disposed within the second segment b, meaning that the pressure sensor 21 is closer to the distal end of the first sheath 22 than to the proximal end. For ease of description, the first sheath 22 is divided into a first segment a and a second segment b connected to the distal end of the first segment a. The first segment a can be understood as the proximal portion of the first sheath 22, and the second segment b can be understood as the distal portion of the first sheath 22. The first segment a and the second segment b can be integrally formed or connected in segments; this application does not impose any limitation on this.

[0047] The distal end of the second segment b is connected to the interior of the balloon 3 to ensure that the pressure sensor 21 can monitor the pressure inside the balloon 3. One end of the wire 24 is connected to the pressure sensor 21, and the other end of the wire 24 extends beyond the proximal end of the first segment a. At least the distal portion of the wire 24 is suspended inside the first protective tube 22 so that the pressure sensor 21 remains suspended inside the second segment b.

[0048] The balloon catheter provided in this embodiment utilizes a combination design of the first sheath 22 and the filler 23 to install a pressure sensor 21 inside the balloon 3 to keep it suspended. The addition of the pressure sensor 21 can monitor the pressure inside the balloon 3 in real time throughout the entire process. The device system adjusts according to the obtained pressure information to keep the pressure inside the balloon stable. The stability of the pressure inside the balloon can fix the shape of the balloon, making the device more usable, and also improve the safety of the entire process.

[0049] In this embodiment, preferably, the pressure measuring component 2 further includes a filler 23, and the first segment a of the first protective tube 22 is at least partially filled by the filler 23 to define the position of the wire 24 within the first protective tube 22, thereby suspending the pressure sensor 21 within the first protective tube 22. More preferably, the wire 24 is defined to be coaxially positioned with the first protective tube 22 within the first protective tube 22, thereby suspending the pressure sensor 21 within the first protective tube 22.

[0050] In some other embodiments, the portion of the wire 24 within the first protective tube 22 is fixed proximally to the inner wall of the first protective tube 22, while the distal end is bent, so that the distal portion of the wire 24 remains suspended within the first protective tube 22, thereby keeping the pressure sensor 21, which is fixed to its distal end, suspended within the first protective tube 22. In this embodiment, the rigidity requirement for the guide wire 24 is high, and the first protective tube 22 requires a larger diameter; therefore, in terms of implementation effectiveness, it is not as effective as using the filler 23 for suspension positioning.

[0051] Optionally, the first protective tube 22 is adhered to the catheter body 1 and / or the first protective tube 22 is bound to the catheter body 1, thereby fixing the first protective tube 22 to the catheter body 1. In this embodiment, preferably, the first protective tube 22 is both adhered to and bound to the catheter body 1. Specifically, the pressure measuring assembly 2 may further include a heat shrink tubing 26. The first protective tube 22 can be first adhered to the catheter body 1 with adhesive 25, and then the heat shrink tubing 26 is used to bind the first protective tube 22 to the catheter body 1 to achieve double secure fixation. Specifically, the heat shrink tubing 26 is at least sleeved on the first segment a of the first protective tube 22 and the catheter body 1 corresponding to the first segment a, so as to bind and fix the first protective tube 22 to the catheter body 1.

[0052] Heat shrink tubing shrinks upon heating. When heat shrink tubing 26 is fitted onto the first protective tube 22 and the corresponding portion of the conduit body 1, heating causes shrinkage, resulting in a tight connection between the first protective tube 22 and the conduit body 1. This solves the problem of the pressure sensor 21 being too small, fragile, and difficult to install. It also overcomes the potential risks associated with other binding methods due to low reliability. For example, when using braided thread to bind the first protective tube 22 to the conduit body 1, the braided thread may loosen during actual operation. Binding in this application includes securing the tubing through heat shrinking or by using ropes or other binding methods.

[0053] Preferably, the first protective tube 22 is a polymer material protective tube, that is, the material of the first protective tube 22 is a polymer material, such as PI (polyimide), PA (polyamide), PTFE (tetrafluoroethylene), PEEK (polyether ether ketone), etc. The first protective tube 22 has a certain mechanical strength, so it will not squeeze the pressure sensor 21, and at the same time, it can reduce the risk of scratching the balloon 3 caused by using protective tubes made of similar metal materials.

[0054] In this embodiment, the heat shrink tubing 26 can completely cover the first protective tube 22. However, when the heat shrink tubing 26 completely covers the first protective tube 22, on the one hand, when the balloon deflects, the pressure measurement component will also deflect accordingly. At this time, the first protective tube 22 will be subjected to the force of the heat shrink tubing, causing the pressure sensor 21 to be squeezed, thus affecting the measurement accuracy. On the other hand, when the first protective tube 22 is made of polymer material, heating it after the heat shrink tubing is applied may cause slight deformation of the polymer material, which may very likely cause the internal pressure sensor 21 to be squeezed, affecting the test results. Therefore, in this embodiment, if... Figure 2 As shown, preferably, the heat shrink tubing 26 is only fitted onto the first segment a of the first protective tube 22 and the conduit body 1 corresponding to the first segment a.

[0055] To avoid the filler 23 coming into contact with the pressure sensor 21 during manufacturing or use, which would affect the accuracy of the sensing signal of the pressure sensor 21, it is preferable that the filler 23 and the pressure sensor 21 are spaced at a set distance, the set distance being not less than 0.5mm.

[0056] Further preferably, to simplify the operation, the filler 23 can be obtained by injecting adhesive into the proximal end of the first protective tube 22 and then curing it. In some other embodiments, the wire 24 can also be integrally molded with a polymer material (such as PU, silicone rubber, etc.) and then filled into the proximal end of the first protective tube 22; this application does not limit this.

[0057] Figure 1 The illustration shows a balloon catheter as an example of this embodiment. Specifically, the catheter body 1 includes an outer tube 11 and an inner shaft 12 disposed within the outer tube 11. The distal end of the inner shaft 12 extends out of the outer tube 11. The balloon 3 is sleeved on the inner shaft 12 extending out of the outer tube 11. The balloon 3 includes an inner balloon 31 and an outer balloon 32 covering the inner balloon 31. The distal end of the balloon 3 is connected to the inner shaft 12, and the proximal end of the balloon 3 is connected to the outer tube 11.

[0058] The pressure sensor 21 is fixed to the outer wall of the inner shaft 12 via the first protective tube 22. The wire 24 is arranged along the axial direction of the inner shaft 12, with one end connected to the proximal end of the pressure sensor 21 and the other end extending out of the outer tube 11 along the axial direction of the inner shaft 12, and connected to a device for receiving the sensing signal from the pressure sensor 21. Preferably, the portion of the wire 24 outside the first protective tube 22 is also fixed to the inner shaft 12, for example, it can be fixed to the inner shaft 12 via another heat shrink tubing 27. This avoids excessive bending and deformation of the wire 24 during use, which could cause slippage between the filler 23 and the first protective tube 22, thus affecting the sensing accuracy of the pressure sensor 21.

[0059] A control handle 13 is provided at the proximal end of the catheter body 1. The control handle 13 is disposed on the outer tube 11. The control handle 13 can be used to manipulate and control the bending state of the catheter body 1.

[0060] The control handle 13 is provided with an electrical input / output interface 131. The proximal end of the wire 24 passes through the catheter body 1 and connects to the electrical input / output interface 131 to transmit the detected pressure information to external devices. The control handle 13 may also include: at least one fluid input interface 132; at least one fluid output interface (not shown); and at least one lumen interface 133. The lumen interface 133 is used to insert guidewires, mapping catheters, and deliver contrast agents, etc. The fluid input interface 132 is in fluid communication with the fluid delivery fitting 14 and is used to input externally provided ablation media into the balloon catheter. The fluid output interface is used to discharge the ablation media or other media from the balloon 3. This application provides one example of the control handle 13. Of course, in other embodiments, other interfaces may be provided on the control handle 13, or multiple functions may be integrated into one interface. The number and functions of the interfaces can be adjusted according to the actual situation, and this application does not limit this. Furthermore, the catheter body 1 also includes a fluid delivery fitting 14, which is also inserted into the outer tube 11 and specifically positioned between the outer tube 11 and the inner shaft 12. The fluid delivery fitting 14 is also provided with a fluid injection port (not shown) facing the surface of the inner balloon 31 for injecting the ablation medium X into the interior of the inner balloon 31. Preferably, the fluid injection port is located within the hemisphere of the balloon 3 near its distal end, allowing for closer proximity to the pulmonary vein opening to be ablated, thereby utilizing cryo-energy more efficiently and saving energy. More preferably, the cryo-fluid is carbon dioxide or nitrous oxide.

[0061] Furthermore, such as Figure 1As shown, the fluid delivery fitting 14 specifically includes a distal spiral structure 141 and a longitudinally extending portion fluidly communicating with the spiral structure 141. The longitudinally extending portion passes through the conduit body 1 and connects to the fluid input interface 132. The spiral structure 141 preferably has multiple fluid injection ports, which are used to inject the ablation medium in different directions.

[0062] Furthermore, the inner shaft 12 is a hollow structure and is movably disposed within the outer tube 11. The inner shaft 12 can be moved within the outer tube 11 by adjusting the control handle 13 to complete the release and retraction of the balloon 3 from its sheath. The proximal end of the inner shaft 12 is connected to the inner lumen interface 133 on the control handle 13 for delivering related instruments such as guidewires, mapping catheters, or contrast fluid. The catheter body 1 also includes a fluid discharge channel disposed between the inner shaft 12 and the outer tube 11 for draining fluid from the balloon 3. Additionally, the distal end of the inner shaft 12 extending from the balloon 3 is preferably provided with a soft tip 15. The soft tip 15 is made of a soft material to avoid tissue damage. Preferably, the distal end of the inner shaft 12 is provided with a contrast marker 16. The contrast marker 16 is made of a metallic contrast-enhancing material. During the procedure, the surgeon can use contrast equipment to confirm the position of the balloon 3 relative to the outer sheath through the contrast marker 16.

[0063] Furthermore, embodiments of the present invention also provide an electrophysiological system, including: a balloon catheter 100, an ablation energy output device 200, and a control device 300, wherein the ablation energy output device 200 is in fluid communication with the balloon catheter 100 to provide an ablation medium to the balloon catheter 100. In some embodiments, the control device 300 is connected to the ablation energy output device 200, which in turn is connected to the balloon catheter 100. In other embodiments, the control device 300 may also be connected to both the ablation energy output device 200 and the balloon catheter 100. In still other embodiments, the control device 300 and the ablation energy output device 200 may be integrated into the same device, and the present invention does not limit this.

[0064] The control device 300 is used to control the ablation energy output device 200 to adjust the output of the ablation medium according to the pressure information detected by the pressure sensor 21, so that the internal pressure of the balloon 3 is within the target range.

[0065] like Figure 3 As shown, an electrophysiological system can be applied to cardiac therapy. A balloon catheter 100 can be inserted into the cardiac chamber via interventional procedures to ablate pulmonary vein A, thereby treating arrhythmias. Or, as... Figure 4 As shown, the electrophysiological system can also be applied to the renal artery. The balloon catheter 100 is placed at the inlet B of the renal artery via interventional means to ablate the renal artery C, thereby regulating the renal artery blood pressure.

[0066] Furthermore, taking pulmonary vein cryoablation as an example, combined with Figure 3 and Figure 4 The working principle of the electrophysiological system provided in the embodiments of the present invention will be further explained.

[0067] Step 1: Connect the control handle 13 of the balloon catheter 100 to the ablation energy output device 200.

[0068] Step two: Insert the balloon catheter 100 into the target tissue for the ablation procedure, such as inserting it into the tubular tissue inside the heart chamber, i.e., into the pulmonary vein opening.

[0069] Step 3: Inflate balloon 3 and release ablation medium (i.e., cryo-liquid) into balloon 3.

[0070] Step 4: Adjust the position of balloon 3 in the tubular tissue.

[0071] Step 5: Begin cryoablation.

[0072] Step six: Adjust the output of the ablation medium based on the pressure information detected by the pressure sensor 21, so that the internal pressure of the balloon 3 is within the target range until the ablation is completed.

[0073] In this embodiment, the control device 300 may specifically include a cooling control unit. The ablation energy output device 200 may specifically include a cooling unit, a fluid source, and a fluid output channel. The fluid source is connected to the fluid output channel, which is then used to output fluid from the fluid source to the balloon catheter 100. For example, the fluid output channel is connected to the fluid input interface 132 on the control handle 13, through which the ablation medium is input to the balloon catheter 100. The cooling unit is disposed on the fluid output channel and is used to cool the fluid transported in the fluid output channel. The cooling unit may be a compressor or other cooling device, and its structure is not specifically limited in this invention. The cooling unit is used to communicate with the cooling control unit so that the cooling control unit can control the working state of the cooling unit. Furthermore, the cooling control unit is used to control the cooling unit to work according to the received cryoablation command, so that the fluid output channel provides cryofluid to the balloon catheter 100. In this embodiment of the invention, a cryoablation button may be provided on the control handle 13 or the computer interface. When the operator activates the cryoablation button, a cryoablation command is sent to the cooling control unit. The computer interface can be located on the control device 300 or the ablation energy output device 200. In a non-limiting operation, the refrigeration control unit sends a refrigeration signal to the refrigeration unit, and the refrigeration unit performs refrigeration according to the received refrigeration signal.

[0074]

Example 2

[0075] This embodiment is similar to Embodiment 1, and the similarities will not be repeated. The difference from Embodiment 1 is that in this embodiment, the first protective tube 22 is only partially fixed to the catheter body 1. For details, please refer to... Figure 5 The first segment a is at least partially filled by the filler 23, and the pressure sensor 21 is disposed in the second segment b. The first segment a is fixed to the outer wall of the catheter body 1, and the second segment b has a degree of freedom relative to the catheter body 1.

[0076] Similarly, in this embodiment, the first segment a can be fixed to the catheter body 1 by adhesive and / or binding. Specifically, in this embodiment, the pressure measuring component 2 also includes a heat shrink tubing 26, which is sleeved on the first segment a and the catheter body 1 corresponding to the first segment a, to bind the first segment a to the catheter body 1. When fixing the first protective tube 22, the first segment a can first be fixed to the outer wall of the catheter body 1 with glue, and then the heat shrink tubing 26 can be used to bind the first segment a to the catheter body 1.

[0077] During use, the inner shaft of the balloon catheter, where the pressure sensor 21 is located, will bend, along with the first sheath 22. If the first sheath 22 bends, the pressure sensor 21 will be compressed by the sheath wall, affecting its performance, such as the accuracy of pressure monitoring. The partial fixing design of this embodiment ensures that during use, at least the portion of the first sheath 22 containing the pressure sensor 21 does not bend with the catheter body 1, but maintains a certain straightness. This avoids the impact of balloon contraction and inner shaft bending on the sensor during actual use.

[0078] This embodiment only describes the improvements based on the balloon catheter provided in Embodiment 1. Other structures and connections are the same as in Embodiment 1 and will not be repeated here.

[0079]

Example 3

[0080] This embodiment is similar to Embodiment 1, and the similarities will not be repeated here. Please refer to [link / reference]. Figure 6Unlike Embodiment 1 and Embodiment 2, in this embodiment, the pressure measuring component 2 further includes a second protective tube 28. The second protective tube 28 is sleeved over a portion of the wire 24 and passes through the first protective tube 22. The filler 23 fills the inside of the second protective tube and the gap between the second protective tube 28 and the first protective tube 22 to define the coaxial arrangement of the second protective tube 28 and the first protective tube 22, thereby defining the position of the wire 24 within the first protective tube 22. This design further ensures that the pressure sensor 21 is suspended within the first protective tube 22. The material of the second protective tube 28 can also be a polymer material, such as PI (polyimide), PA (polyamide), PTFE (tetrafluoroethylene), PEEK (polyether ether ketone), etc., which has a certain mechanical strength.

[0081] Because the pressure sensor 21 is relatively small and the wire 24 is relatively thin, after being inserted into the first protective tube 22, the wire 24 undergoes slight bending deformation, which can easily cause the pressure sensor 21 to be in an off-center position, hindering its normal operation. In this embodiment, the balloon catheter has a section of the second protective tube 28 fitted over the wire 24. The second protective tube 28 provides some support for the wire 24 and the pressure sensor 21. After the pressure sensor 21 is inserted into the first protective tube 22, the second protective tube 28 can be adjusted to be coaxial with the first protective tube 22, ensuring that the pressure sensor 21 is suspended within the first protective tube 22.

[0082] Preferably, the proximal end of the second sheath 28 extends from the proximal end of the first sheath 22 to facilitate the execution of the positioning operation.

[0083] In this embodiment, the first protective tube 22 can be completely fixed to the catheter body 1, or as described in Embodiment 2, only the proximal part can be fixed to the catheter body 1. Other structures and relationships are the same as in Embodiment 1 and Embodiment 2. For details, please refer to the descriptions of Embodiment 1 and Embodiment 2, which will not be repeated here.

[0084]

Example 4

[0085] In this embodiment, please refer to Figure 7The first protective tube 22 also includes a first segment a and a second segment b connected to the distal end of the first segment a. Unlike the previous embodiments, this embodiment does not rely on the filler 23 to keep the wire 24 coaxial with the first protective tube 22 within the first protective tube 22. Specifically, in this embodiment, the first protective tube 22 adopts a non-uniform diameter tubular structure design. At least a portion of the first segment a has a relatively small inner diameter relative to the rest of the first protective tube 22. The inner diameter of this portion matches the outer diameter of the wire 24 of the pressure sensor 21. For example, the inner diameter of this portion can be slightly larger than the outer diameter of the wire 24. When the first protective tube 22 adopts this structural design, the first protective tube 22 itself can coaxially limit the wire 24 through the first segment a. Compared with the method in Embodiment 3 where the second protective tube 28 is used to limit coaxiality, requiring manual adjustment of the position of the second protective tube 28 within the first protective tube 22, this method is more reliable and easier to operate. In this embodiment, the pressure sensor 21 can be inserted from the distal end of the first protective tube 22, and the wire 24 can be inserted from the proximal end of the first protective tube 22.

[0086] Furthermore, to reduce the difficulty of threading the wire 24 through the first segment a, as mentioned above, the inner diameter of the first segment a can be slightly larger than the outer diameter of the wire 24. In this case, the first segment a can still provide a good limiting effect. Moreover, after the wire 24 exits from the proximal end of the first protective tube 22, glue can be used to fill the gap between the first segment a and the wire 24 to better fix the position of the wire 24 within the first segment a.

[0087] As can be seen from the above description, although this embodiment does not rely on the filler to limit the position of the wire 24 in the first segment a, in order to reduce the difficulty of operation, this embodiment can also use a design scheme with a relatively small inner diameter in the first segment a, and combine glue filling for further limiting. However, it should be understood that the addition of the filler does not constitute a limitation on this embodiment.

[0088] Similarly, in this embodiment, the first protective tube 22 can be completely fixed to the catheter body 1, or as described in Embodiment 2, only the proximal part can be fixed to the catheter body 1, and the other structures and relationships are the same as in Embodiment 1 and Embodiment 2. For details, please refer to the descriptions of Embodiment 1 and Embodiment 2, which will not be repeated here.

[0089] In summary, the balloon catheter and electrophysiological system provided in this embodiment of the invention include: a catheter body, a balloon, and a pressure measurement component; the balloon is fitted inside the catheter body; the pressure measurement component is disposed inside the balloon, and the pressure measurement component includes a first sheath, a pressure sensor, and a lead wire; the first sheath is fixed to the outer wall of the catheter body along the axial direction of the catheter body; the first sheath includes a first segment and a second segment connected to the distal end of the first segment, the distal end of the second segment communicating with the interior of the balloon; the pressure sensor is disposed inside the second segment; one end of the lead wire is connected to the pressure sensor; the other end of the lead wire extends beyond the proximal end of the first segment, and at least the distal portion of the lead wire is suspended inside the first sheath, so that the pressure sensor remains suspended inside the second segment. In this way, a pressure sensor that keeps the balloon suspended is installed inside the balloon. The addition of this pressure sensor can monitor the pressure inside the balloon in real time throughout the entire process. The equipment system adjusts according to the obtained pressure information to keep the pressure inside the balloon stable. The stability of the pressure inside the balloon can not only fix the shape of the balloon and improve the performance of the catheter, but also improve the safety of the entire process.

[0090] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Similar or identical parts between embodiments can be referred to mutually. In addition, different parts between embodiments can also be combined with each other, and this invention does not limit this.

[0091] Furthermore, it should be understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments with equivalent changes, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the present invention shall still fall within the scope of protection of the present invention.

Claims

1. A balloon catheter, characterized in that, include: Catheter body; A balloon, fitted over the catheter body; and, A pressure measurement assembly is disposed within the balloon. The pressure measurement assembly includes a first sheath, a pressure sensor, and a lead wire. The first sheath is fixed to the outer wall of the catheter body along the axial direction of the catheter body. The first sheath includes a first section and a second section connected to the distal end of the first section. The distal end of the second section communicates with the interior of the balloon. The pressure sensor is disposed within the second section. One end of the lead wire is connected to the pressure sensor, and the other end of the lead wire extends beyond the proximal end of the first section. At least the distal portion of the lead wire is suspended within the first sheath, so that the pressure sensor remains suspended within the second section. The first segment is fixed to the outer wall of the catheter body, and the second segment has a degree of freedom relative to the catheter body.

2. The balloon catheter as described in claim 1, characterized in that, The pressure measuring assembly further includes a filler, wherein at least a portion of the first segment of the first sheath is filled with the filler to define the position of the conductor within the first segment of the first sheath, such that at least a distal portion of the conductor is suspended in the first sheath.

3. The balloon catheter as described in claim 2, characterized in that, The pressure measuring assembly further includes a heat shrink tubing, which is at least sleeved on the first section of the first protective tube and the conduit body corresponding to the first section of the first protective tube, so as to fix the first protective tube to the conduit body.

4. The balloon catheter as described in claim 3, characterized in that, The heat shrink tubing is only fitted onto the first segment and the corresponding conduit body to fix the first segment to the conduit body.

5. The balloon catheter as described in claim 1 or 2, characterized in that, The inner diameter of at least a portion of the first segment is smaller than the inner diameter of the second segment and matches the outer diameter of the conductor, so that the conductor is coaxially arranged with the first protective tube inside the first protective tube.

6. The balloon catheter as described in claim 2, characterized in that, The pressure measuring assembly further includes a second protective tube, which is sleeved inside the first protective tube and covers a portion of the wire. The filler is filled inside the second protective tube and in the gap between the second protective tube and the first protective tube to define that the second protective tube and the first protective tube are coaxially arranged, thereby defining the position of the wire inside the first protective tube.

7. The balloon catheter as described in claim 2, characterized in that, The distance between the filler and the pressure sensor is not less than 0.5 mm.

8. The balloon catheter as described in claim 2, characterized in that, The filler is obtained by injecting adhesive from the proximal end of the first protective tube and then curing it.

9. The balloon catheter as described in claim 1, characterized in that, The first protective tube is a polymer material protective tube.

10. The balloon catheter as claimed in claim 1, characterized in that, The catheter body includes an outer tube and an inner shaft disposed in the outer tube. The distal end of the inner shaft extends out of the outer tube. The balloon is sleeved on the inner shaft extending out of the outer tube. The distal end of the balloon is connected to the inner shaft, and the proximal end of the balloon is connected to the outer tube. The pressure sensor is fixed to the outer wall of the inner shaft through the first protective tube. The wire is arranged along the axial direction of the inner shaft.

11. An electrophysiological system, characterized in that, The device includes a balloon catheter, an ablation energy output device, and a control device as described in any one of claims 1 to 10, wherein the ablation energy output device is connected to the balloon catheter and is used to provide an ablation medium to the balloon catheter; and the control device is used to control the ablation medium energy output device to adjust the output amount of the ablation medium according to the pressure information detected by the pressure sensor, so that the internal pressure of the balloon is within a target range.

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