Left heart drainage catheter and drainage catheter system

Abstract

The invention relates to the field of left heart drainage catheters, and provides a left heart drainage catheter and a drainage catheter system. The left heart drainage catheter comprises an operating handle and a catheter body; the catheter body comprises a reducing section, and the reducing section is provided with an ablation electrode; the left heart drainage catheter further comprises a reducing adjusting mechanism, and the reducing adjusting mechanism is used for enabling the near end and the far end of the reducing section to get close to each other and get away from each other in the axial direction of the catheter body so that the reducing section can change the outer diameter. The catheter body further comprises an electrode wire connected to the ablation electrode, the operating handle comprises an electric connecting part, and the electric connecting part is used for being connected with an ablation host so as to provide ablation energy for the ablation electrode. The technical problems that left atrium drainage and atrial septal stoma operation steps are many, and operation is complex are mainly solved.

Description

Technical Field

[0001] This invention relates to a left ventricular drainage catheter. Background Technology

[0002] The incidence of cardiovascular diseases is rising annually, and some patients may develop end-stage heart failure, for which drug treatment has limited effectiveness. In recent years, left ventricular assist devices (LVADs) have seen rapid development. These devices can be implanted percutaneously or via open-chest surgery, partially replacing the heart's pumping function, significantly improving hemodynamics, reducing cardiac workload, and providing short-term or long-term circulatory support in cases of acute heart failure or heart transplantation. Traditional implantable LVADs use an implanted pump to draw blood from the left ventricle and pump it directly into the ascending aorta, bypassing the failing left ventricle and reducing its burden. This requires surgical intervention under cardiopulmonary bypass, resulting in high surgical risks and a high postoperative mortality rate. Percutaneous ventricular assist devices (pVADs) are mechanical circulatory assist devices implanted percutaneously for short-term support of the heart's pumping function. They reduce trauma, rapidly establish circulatory access, reduce left ventricular workload, and restore perfusion to vital organs.

[0003] Among various interventional ventricular assist devices (VADs), the percutaneous transseptal ventricular assist device (PTVA), an FDA-approved short-term circulatory support measure via the left atrial-femoral artery pathway, avoids the risks of open-heart surgery compared to traditional VADs, and is relatively inexpensive and easy to operate. The PTVA mainly consists of a cardiopulmonary bypass pump, an arterial perfusion cannula, and a left ventricular drainage catheter. During the procedure, the left ventricular drainage catheter reaches the left atrium via the femoral vein and interatrial septum, while the arterial perfusion cannula reaches the descending aorta via the femoral artery and connects to the cardiopulmonary bypass pump, forming a complete blood circulation pathway. The PTVA effectively reduces left ventricular workload and significantly improves the patient's cardiac index and mean arterial pressure.

[0004] Patients with left ventricular failure often have severe left atrial ejection dysfunction, leading to elevated left atrial pressure (LAP), which in turn causes pulmonary edema and upper body hypoxia. Besides the aforementioned short-term circulation procedure via the left atrial-femoral artery pathway, adjusting left ventricular pressure can also be achieved through atrial septostomy (achieving left-to-right shunt). Balloon atrial septostomy (BAS) is a mature interventional technique primarily used for palliative bridging therapy in complex congenital heart diseases. It reduces left atrial overload in HFpEF (Heart Failure with Preserved Ejection Fraction, also known as diastolic heart failure), thereby improving patients' clinical symptoms, exercise tolerance, and prognosis.

[0005] In some treatments, in addition to draining the left atrium through a left ventricular drainage catheter, an atrial septalostomy is also required. The relevant techniques need to be performed step by step, which not only increases the cost to the patient, but also prolongs the operation time and increases the surgical risk. Summary of the Invention

[0006] This invention mainly solves the technical problem of the numerous and complex procedures involved in left atrial drainage and atrial septal stoma.

[0007] In a first aspect, the present invention provides a left ventricular drainage catheter, comprising:

[0008] An operating handle and a tube body connected to the operating handle;

[0009] The tube body includes a variable diameter section, and the variable diameter section is provided with an ablation electrode;

[0010] The left ventricular drainage catheter also includes a diameter adjustment mechanism, which is used to move the proximal and distal ends of the diameter-changing section closer to each other and further apart along the axial direction of the tube body, so as to cause a change in the outer diameter of the diameter-changing section.

[0011] The tube body also includes an electrode wire connected to the ablation electrode. The operating handle includes an electrical connection component. The proximal end of the electrode wire is connected to the electrical connection component. The electrical connection component is connected to the ablation host to provide ablation energy to the ablation electrode.

[0012] In some embodiments, the variable diameter section includes an elastic skeleton and a flexible membrane. The elastic skeleton is distributed circumferentially along the tube body, and the flexible membrane is connected to the elastic skeleton. The gap between two adjacent elastic skeletons along the circumferential direction of the tube body is closed by the flexible membrane. The ablation electrode is disposed on the elastic skeleton and / or the flexible membrane.

[0013] In some embodiments, the tube body is provided with a wire channel that extends along the length of the tube body, and the electrode wire is disposed within the wire channel.

[0014] In some embodiments, the variable diameter section includes a flexible circuit board connected to the surface of the elastic skeleton, and the ablation electrode is disposed on the flexible circuit board.

[0015] In some embodiments, the flexible circuit board includes conductive lines connected to the electrode wires for electrical connection to the ablation electrode via the conductive lines.

[0016] In some embodiments, an electrode mounting groove is provided on the radially outer side of the elastic skeleton, at least a portion of the ablation electrode is embedded in the electrode mounting groove, and a wire outlet hole is provided on the bottom wall of the electrode mounting groove, through which the electrode wire is led out.

[0017] In some embodiments, the variable diameter section includes a proximal tube body disposed at the proximal end and a distal tube body disposed at the distal end, and the elastic skeleton is connected between the proximal tube body and the distal tube body.

[0018] In some embodiments, the variable diameter section includes a sensing element disposed at the proximal and / or distal end of the elastic frame, the sensing element being at least one of a pressure sensor, a temperature sensor, and a positioning sensor.

[0019] In some embodiments, the tube body includes a drainage tube and a movable sleeve; the drainage tube has a drainage channel inside, and the distal end of the drainage tube has a drainage port communicating with the drainage channel; the movable sleeve is sleeved outside the drainage tube and can move along the drainage tube; the proximal end of the variable diameter section is fixed to the distal end of the movable sleeve, and the distal end of the variable diameter section is fixed to the drainage tube and located on the proximal side of the drainage port; the variable diameter adjustment mechanism is disposed on the operating handle, and the proximal end of the movable sleeve is connected to the output end of the variable diameter adjustment mechanism.

[0020] In some embodiments, the tube body includes a drainage tube and a fixed sleeve. The drainage tube has a drainage channel inside, and the distal end of the drainage tube has a drainage port communicating with the drainage channel. The fixed sleeve is sleeved outside the drainage tube and fixedly connected to the drainage tube. The proximal end of the variable diameter section is fixed to the distal end of the fixed sleeve. A pulling rope is provided inside the fixed sleeve. The distal end of the pulling rope is connected to the distal end of the variable diameter section, and the proximal end of the pulling rope is connected to the variable diameter adjustment mechanism.

[0021] In some embodiments, the drainage tube includes a support section and a bending section, the bending section being connected to the distal end of the support section, the movable sleeve being fitted onto the support section, and the distal end of the variable diameter section being located on the proximal side of the bending section.

[0022] In a second aspect, the present invention provides a drainage catheter system, comprising:

[0023] The left ventricular drainage catheter described in any of the above items;

[0024] And an ablation host, which is used to provide ablation energy to the ablation electrode.

[0025] According to an embodiment of the present invention, the left ventricular drainage catheter includes a variable diameter section. The variable diameter section is equipped with an ablation electrode and a variable diameter adjustment mechanism that allows the proximal and distal ends of the variable diameter section to move closer and further apart along the axial direction of the catheter body, thereby causing changes in the outer diameter of the variable diameter section and achieving different stoma sizes. In conjunction with the ablation electrode, left atrial drainage and atrial septal stoma can be achieved using only the left ventricular drainage catheter. Compared to changing different instruments to perform left atrial drainage and atrial septal stoma separately, this saves operation steps, simplifies the complexity of the operation, and improves the convenience of the surgery. Attached Figure Description

[0026] Figure 1 This is a schematic diagram illustrating a usage scenario of an embodiment of the drainage catheter system in this invention;

[0027] Figure 2 This is a schematic diagram of one embodiment of a left ventricular drainage catheter;

[0028] Figure 3 This is a schematic diagram of an ablation procedure performed using an embodiment of a left ventricular drainage catheter.

[0029] Figure 4 This is a schematic diagram of the variable diameter section in one embodiment of a left ventricular drainage catheter;

[0030] Figure 5 This is a schematic diagram of the deformable shape of the variable diameter section in one embodiment of the left ventricular drainage catheter;

[0031] Figure 6 This is a schematic diagram of the assembly structure of the ablation electrode in one embodiment of the left ventricular drainage catheter;

[0032] Figure 7 This is a schematic diagram of another assembly structure for the ablation electrode;

[0033] Figure 8 This is a schematic diagram of the assembly structure of the electrode leads in one embodiment of the left ventricular drainage catheter;

[0034] Figure 9 This is an operation flowchart of an embodiment of the drainage catheter system in this invention.

[0035] List of feature names corresponding to the labels in the figure:

[0036] 100. Extracorporeal circulation pump;

[0037] 200. Arterial perfusion tubing;

[0038] 300. Left ventricular drainage catheter; 301. Operating handle; 3011. Electrical connection component; 302. Tube body; 3021. Lead wire channel; 3031. Drainage tube; 3032. Movable sleeve; 304. Variable diameter section; 3041. Elastic skeleton; 3042. Electrode mounting slot; 3043. Outlet hole; 3044. Flexible circuit board; 3045. Flexible membrane; 3046. Proximal tube body; 3047. Distal tube body; 3048. Adhesive point; 305. Electrode lead wire;

[0039] 310. Support section;

[0040] 320. Bend section; 321. Lateral drainage hole; 322. Distal drainage port;

[0041] 331. Flexible drainage tube; 332. Hemostatic valve; 333. Tailstock;

[0042] 340. Ablation electrode; 341. Main electrode; 342. Auxiliary electrode;

[0043] 350. Sensing elements;

[0044] 410. Heart; 411. Left atrium; 412. Right atrium; 413. Pulmonary vein; 420. Descending aorta; 430. Femoral vein; 440. Femoral artery; 450. Atrial septum;

[0045] 500, Ablation host.

[0046] For figure reference numerals enclosed in parentheses, the feature referred to by the reference numeral is the feature represented by both the number inside the parentheses and the number outside the parentheses. Detailed Implementation

[0047] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments. Similar elements in different embodiments are referred to by related similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of the present application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to the present application are not shown or described in the specification. This is to avoid obscuring the core parts of the present application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0048] The embodiments described in the detailed implementation can be combined in any suitable manner without contradiction. For example, different implementation methods can be formed by combining different embodiments. In order to avoid unnecessary repetition, the various possible combinations of the embodiments will not be described separately.

[0049] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0050] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0051] Please refer to Figure 1 , Figure 1 This is a schematic diagram of a usage scenario of an embodiment of the drainage catheter system in this invention. The drainage catheter system includes a left ventricular drainage catheter 300 and an ablation host 500. The drainage catheter system can be used for a left ventricular assist device. In addition to the drainage catheter system, the left ventricular assist device also includes an extracorporeal circulation pump 100 and an arterial perfusion tube 200.

[0052] Those skilled in the art will understand that the extracorporeal circulation pump 100 is used to drive blood to be drawn from the left atrium 411 or pulmonary vein and delivered to the arterial system, thereby replacing or assisting the left ventricular pumping function. The extracorporeal circulation pump 100 can be of any suitable type, such as a peristaltic pump or a centrifugal pump. The left ventricular drainage catheter 300 can be percutaneously inserted into the left atrium 411 or pulmonary vein to draw blood from the left atrium 411 or pulmonary vein to the extracorporeal circulation pump 100, which can, for example, reduce the left ventricular filling pressure, alleviate pulmonary congestion and pulmonary edema, and unload the left ventricle. The arterial perfusion catheter 200 is used to return the blood pumped by the extracorporeal circulation pump 100 to the systemic circulation, for example, by injecting it into the aorta through the femoral artery 440, which can maintain the perfusion of the corresponding organs and ensure the blood and oxygen supply to vital organs. The specific structures of the extracorporeal circulation pump 100 and the arterial perfusion catheter 200 can be referenced from existing structures in related technologies; however, considering that they are not directly related to the innovative content and technical problem to be solved in this application, they will not be described in detail here. Local aspects of the human body's systemic circulation can be referenced. Figure 1 It includes the heart 410, descending aorta 420, femoral vein 430, femoral artery 440, and the heart 410 includes the left atrium 411, right atrium 412, interatrial septum 450, and pulmonary vein 413.

[0053] Please refer to Figure 2 The left ventricular drainage catheter 300 includes an operating handle 301 and a tube body 302, with the proximal end of the tube body 302 connected to the operating handle 301. The operating handle 301 allows the user to grip and perform corresponding operations, and its specific operating functions can be designed as needed. A drainage channel is provided within the drainage tube 3031, through which blood is drained via the left ventricular drainage catheter 300. A drainage port communicating with the drainage channel is located at the distal end of the drainage tube 3031. The drainage channel can be formed by the lumen of the drainage tube 3031, and the shape, size, and number of lumens can be set as needed.

[0054] Those skilled in the art should understand that the terms "proximal" and "distal" used in this article are conventional medical terms. For the instrument to be operated on, the proximal end is the end closer to the user, and the distal end is the end furthest from the user, usually the end that first enters the patient's body. For more information on proximal and distal ends, please refer to [reference needed]. Figure 2 The orientation shown in the diagram. Accordingly, the proximal-distal direction is the direction from the proximal end to the distal end or from the distal end to the proximal end of the corresponding component.

[0055] In some embodiments, please refer to Figure 2 , Figure 3 and Figure 4 The tube body 302 includes a drainage tube 3031 and a movable sleeve 3032. The movable sleeve 3032 is fitted over the drainage tube 3031 and can move along the drainage tube 3031. The tube body 302 includes a reducing section 304, the proximal end of which is fixed to the distal end of the movable sleeve 3032, and the distal end of which is fixed to the drainage tube 3031 and located on the proximal side of the drainage port. The fixing connection method is not limited. The drainage port may include a lateral drainage hole 321 and a distal drainage port 322. The drainage channel can extend through the distal end of the bending section 320 to form the distal drainage port 322, which is beneficial for inserting an expander through the lumen of the drainage tube 3031 and can also form a guide wire channel.

[0056] In some embodiments, the variable diameter section 304 includes an elastic skeleton 3041 and a flexible membrane 3045. The elastic skeleton 3041 is distributed circumferentially along the tube body 302, and the flexible membrane 3045 is connected to the elastic skeleton 3041. The gap between two adjacent elastic skeletons 3041 along the circumferential direction of the tube body 302 is closed by the flexible membrane 3045. The flexible membrane 3045 forms a closed, expandable structure, creating a flat intercompartmental contact surface, preventing blood from stagnating in the gaps between the elastic skeletons 3041, and thus reducing the risk of thrombosis. In some other embodiments, the flexible membrane 3045 may be omitted. When the movable cannula 3032 moves along the drainage tube 3031, the proximal and distal ends of the variable diameter section 304 move closer and further apart along the axial direction of the tube body 302, so that the outer diameter of the variable diameter section 304 changes, providing physical expansion force to the puncture site of the atrial septum 450. The diameter of the atrial septum 450 stoma can be adjusted according to the treatment needs of different patients, and the blood flow between the left atrium 411 and the right atrium 412 can be selectively controlled.

[0057] In some embodiments, the flexible membrane 3045 may cover the inner or outer side of the elastic skeleton 3041 or be located on the same surface as the elastic skeleton 3041. The flexible membrane 3045 can expand and contract compliantly with the elastic skeleton 3041 to form a closed and uniform ellipsoid, which can prevent body tissue from being embedded in the gaps between the elastic skeleton 3041, making the channels on the interatrial septum 450 more uniform and more circular.

[0058] In some specific embodiments, the variable diameter section 304 can be a separate tube, with its proximal end fixedly connected to the distal end of the movable sleeve 3032. The specific connection method is not limited, such as bonding or welding. Exemplarily, the separate tube can be a section of nickel-titanium tubing or a polymer tubing (such as PA, PI, etc.). By cutting a portion of material axially from the separate tube, multiple elongated spindle-shaped grooves are formed. An elastic skeleton 3041 can be formed between adjacent circumferentially adjacent spindle-shaped grooves. The portions of the separate tube at both ends of the spindle-shaped grooves are complete tubes. The variable diameter section 304 forms a proximal tube 3046, and the distal end of the variable diameter section 304 forms a distal tube 3047. The elastic skeleton 3041 connects the proximal tube 3046 and the distal tube 3047. When the variable diameter section 304 is axially compressed, the elastic skeleton 3041 can undergo bending deformation, gradually producing a morphological change from a straight tube state to a spindle state to an ellipsoidal state, as can be seen from [reference needed]. Figure 5 In the figures (a), (b), and (c), (a) is a straight tube, (b) is a spindle shape, and (c) is an ellipsoid. In some other embodiments, the elastic skeleton 3041 can also be formed in other ways, for example, each elastic skeleton 3041 can be formed separately and then connected between the two tube sections.

[0059] For example, the flexible film 3045 can be made of thermoplastic polyurethane (TPU) or medical silicone, and formed using dip coating, spray coating, or lamination techniques. Taking the formation of the flexible film 3045 using TPU dip coating technology as an example, thermoplastic polyurethane (TPU) can be dissolved in a solvent to form a solution, and the tube with the formed elastic skeleton 3041 can be pretreated (such as etching treatment; those skilled in the art will understand that etching refers to immersing the material in a corresponding solution to improve the surface energy of the material, thereby enhancing its adhesion, printability, or ability to be composite with other materials). Then, the tube with the formed elastic skeleton 3041 is fitted onto a corresponding mold, and the solution is completely immersed in the tube for a certain period of time. Then, the mold is removed, and a thin film of solution is retained in the surface of the elastic skeleton 3041 and the gap between adjacent elastic skeletons 3041. After drying, a dense elastic film is formed, namely the aforementioned flexible film 3045.

[0060] The variable diameter section 304 also includes an ablation electrode 340 disposed on the elastic skeleton 3041 and / or the flexible membrane 3045, and the tube body 302 also includes an electrode wire 305 connected to the ablation electrode 340; the operating handle 301 includes an electrical connection component 3011, the proximal end of the electrode wire 305 is connected to the electrical connection component 3011, and the electrical connection component 3011 is connected to the ablation host 500 to provide ablation energy to the ablation electrode 340. In some embodiments, the ablation electrode 340 includes a main electrode 341 disposed on the elastic skeleton 3041 and an auxiliary electrode 342 disposed on the outer surface of the flexible membrane 3045. The auxiliary electrode 342 and the main electrode 341 cooperate to form a more uniform and stable electric field, resulting in better ablation effect.

[0061] In some specific embodiments, such as Figure 6 As shown, the variable diameter section 304 includes a flexible circuit board 3044 connected to the surface of the elastic skeleton 3041. The flexible circuit board 3044 is provided with an ablation electrode 340, facilitating the forming and lead-out of the main electrode 341. The flexible circuit board 3044 includes a flexible substrate (such as a polyimide (PI) or PET film) and conductive lines (not shown). The conductive lines are connected to the electrode wires 305 to electrically connect to the ablation electrode 340. Those skilled in the art will understand that the conductive lines, i.e., the traces on the flexible circuit board 3044, refer to conductive paths etched or printed on the flexible substrate, typically made of copper foil.

[0062] The flexible circuit board 3044 is bonded and fixed to the elastic skeleton 3041, for example, by adhesive bonding or ultrasonic welding. The flexible ablation electrode 340 can be fabricated using polymer films such as polyimide (PI) or polyethylene terephthalate (PET) as a flexible substrate. A metal layer (such as gold or platinum) is deposited on the substrate using sputtering and evaporation techniques to form a conductive layer, exhibiting high conductivity and high flexibility, allowing it to expand and contract well with the elastic skeleton 3041. The flexible ablation electrode 340 can also be bonded to the outer surface of the flexible film 3045 when it expands into a sphere, forming an auxiliary electrode 342.

[0063] like Figure 7 As shown, in some other embodiments, the elastic skeleton 3041 has an electrode mounting groove 3042 on its radially outer side. At least a portion of the ablation electrode 340 is embedded in the electrode mounting groove 3042. The bottom wall of the electrode mounting groove 3042 has a wire outlet hole 3043, from which the electrode wire 305 is led out. Exemplarily, the electrode mounting groove 3042 can be pre-carved with a corresponding groove at the designed position of the ablation electrode 340 using laser engraving or precision machining technology, and the wire outlet hole 3043 of the electrode wire 305 is machined at the center point of the groove. After the ablation electrode 340 and the electrode wire 305 are welded, they are placed in the preset groove position and the electrode wire 305 is led out from the wire outlet hole 3043. Then, the gap between the ablation electrode 340 and the inner wall of the groove is filled with glue to form an adhesive point 3048, thereby fixing the main electrode 341.

[0064] It should be noted that the cross-sectional shape of each elastic skeleton 3041 is not limited, and the shape of the ablation electrode 340 can also be designed as needed.

[0065] To connect the ablation electrode 340 to the ablation host 500, in some embodiments, the electrode wire 305 can be disposed within the tube body 302. A wire channel 3021 can be provided within the tube body 302, extending along the length of the tube body 302, and the electrode wire 305 is disposed within the wire channel 3021. For example... Figure 8 As shown, in some specific embodiments, the electrode wire 305 extends from the proximal end of the elastic skeleton 3041, passes through the corresponding cable channel within the movable sleeve 3032, and connects to the tail wire at the operating handle 301. The movable sleeve 3032 can be an integrally extruded multi-cavity polymer tube (such as multi-cavity Pebax, multi-cavity PI), or a composite tube with a multi-cavity PTFE etched tube as the inner layer. After establishing the wire channel 3021, the distal end of the elastic skeleton 3041 is fixed to the root of the bending section 320 by bonding or welding, and the distal end of the movable sleeve 3032 is fixed to the proximal end of the elastic skeleton 3041, for example, by bonding, fusion, welding, or riveting.

[0066] In some embodiments, please refer to Figure 2 The operating handle 301 includes an electrical connection component 3011 to which the proximal end of the electrode lead 305 is connected. The electrical connection component 3011 is connected to the ablation host 500 to provide ablation energy to the ablation electrode 340. The electrical connection component 3011 may include a connecting wire and a connector, and can be detachably connected to the connection terminals on the ablation host 500.

[0067] In some embodiments, such as Figure 4 The variable diameter section 304 may further include a sensing element 350 disposed at the proximal and / or distal ends of the elastic frame 3041. The sensing element 350 is at least one of a pressure sensor, a temperature sensor, and a positioning sensor. The sensing element 350 facilitates the detection of the working status of the left ventricular drainage catheter 300 and / or the ablation electrode 340. The sensing element 350 may also be led out from a corresponding channel within the tube body 302 to the operating handle 301 via a wire.

[0068] The left ventricular drainage catheter 300 also includes a diameter adjustment mechanism. This mechanism is used to move the proximal and distal ends of the diameter-changing section 304 closer together and further apart along the axial direction of the tube body 302, thereby changing the outer diameter of the diameter-changing section 304. The diameter adjustment mechanism is located on the operating handle 301, and the proximal end of the movable sleeve 3032 is connected to the output end of the diameter adjustment mechanism. The specific structure of the diameter adjustment mechanism is not limited, as long as it can drive the movable sleeve 3032 to move in the proximal-distal direction. For example, the diameter adjustment mechanism can be a slider structure, a threaded drive structure, etc. When using a slider structure, a knob that moves in the proximal-distal direction can be provided on the operating handle 301. The proximal end of the movable sleeve 3032 is fixed to the knob, and moving the knob drives the movable sleeve 3032. When a threaded drive structure is adopted, an adjustment knob can be rotated on the operating handle 301. The adjustment knob is connected to the threaded drive component through a threaded structure, which converts the rotation of the adjustment knob into the translation of the drive component along the proximal and distal directions, thereby driving the movable sleeve 3032.

[0069] In some embodiments, the drainage tube 3031 includes a support section 310 and a bending section 320. The bending section 320 is connected to the distal end of the support section 310, and a movable sleeve 3032 is fitted onto the support section 310. The distal end of the reducing section 304 is located on the proximal side of the bending section 320. The support section 310 supports the bending section 320 and is used to move the bending section 320 to a set position. The bending section 320 changes the curvature of the distal end of the drainage tube 3031, allowing for more flexible movement of the drainage tube 3031 to the target position. Furthermore, by changing the curvature of the bending section 320, the drainage tube 3031 can be prevented from contacting the atrial wall, thus improving surgical convenience and safety. The ablation electrode 340 is located on the proximal side of the bending section 320, which helps to avoid compression of the reducing section 304 during bending, thereby ensuring the shape stability of the reducing section 304.

[0070] To achieve the bending of the bending section 320, in some specific embodiments, the drainage tube 3031 may include a bending adjustment cable (obscured in the figure, not shown). The bending adjustment cable is arranged along the length of the drainage tube 3031, and the distal end of the bending adjustment cable is fixed to the distal end of the bending section 320 and offset from the central axis of the bending section 320. The operating handle 301 includes a cable control mechanism, and the proximal end of the bending adjustment cable is connected to the cable control mechanism. The cable control mechanism is used to pull and release the bending adjustment cable to change the bending state of the bending section 320. The specific structural form of the cable control mechanism is not limited, for example, it can be a push button that can move along the proximal and distal ends of the operating handle 301. The cable control mechanism is used to drive the bending adjustment cable connected to the bending section 320 to move, thereby tightening and loosening the bending adjustment cable. Those skilled in the art will understand that the cable control mechanism can also be replaced by other structural forms besides a push button, such as a knob or toggle, and bending can be achieved by winding and releasing the cable.

[0071] In some embodiments, a pull-wire channel is provided within the wall of the drainage tube 3031, and a bending pull wire is disposed within the pull-wire channel. The distal end of the drainage tube 3031 is fixed to the bending pull wire, and the fixing method is not limited. In some specific embodiments, a head end steel ring may be embedded and fixed within the distal end of the bending section 320, and the bending pull wire is fixed to the head end steel ring, for example, by welding, and extends into the pull-wire channel. The forming method of the pull-wire channel is not limited; for example, it can be formed by the corresponding cavity of a multi-cavity tube, or by a separate tube body disposed on one side of the wall of the drainage tube 3031, or by the drainage channel of the drainage tube 3031. In some embodiments, along the radial direction of the drainage tube 3031, a first bending pull wire and a second bending pull wire are respectively provided on opposite sides of the drainage tube 3031, which enables bidirectional bending of the bending section 320 and provides greater flexibility in use.

[0072] In some other embodiments, the bending section 320 can also be replaced with a straight pipe structure, omitting the bending function.

[0073] The ablation electrode 340 can utilize radio frequency (RF) energy. In this case, the ablation host 500 provides RF energy to the ablation electrode 340, which acts as a RF generator. Under the influence of the high-frequency alternating current generated by the RF generator, the ablation electrode 340 causes the ions within the target ablated tissue cells to vibrate at high frequency and generate heat, rapidly reaching 60℃~120℃. This can lead to cell dehydration, protein denaturation, and subsequently coagulative necrosis. The ablation electrode 340 can also utilize pulsed energy. By creating a high-voltage electric field between different electrodes, it causes irreversible electroporation of the cells at the stoma site, ultimately leading to apoptosis (the cell death process: when a pulsed electric field acts on the tissue, it alters the transmembrane potential of the cell, causing a redistribution of charged substances between the extracellular and intracellular spaces, and impairing the physical integrity of the cell membrane. These changes prevent the cell from maintaining a molecular concentration gradient, thus leading to cell death).

[0074] In some embodiments, the left ventricular drainage catheter 300 may include a flexible drain tube 331, which is connected to the operating handle 301 and communicates with the drainage channel. The flexible drain tube 331 can elastically deform under external clamping force to close the internal lumen. The flexible drain tube 331 can be a TPU or PVC extruded soft tube, and its main function is to retract the introduced dilator after the drainage catheter reaches the left atrium 411. If arterial blood in the left atrium 411 flows back to the tail end of the left ventricular drainage catheter 300, the flexible drain tube 331 can be clamped with hemostatic forceps to quickly close the lumen, prevent excess blood from flowing out, and prevent air from entering, so as to facilitate "wet docking" between the tail seat 333 and the connector of the extracorporeal circulation pump 100. Those skilled in the art will understand that wet docking refers to the process of continuously dripping physiological saline at the docking point to expel the air between the docking gaps. The flexible drainage tube 331 can be connected to a hemostatic valve 332 and a tailstock 333 at its end. The hemostatic valve 332 provides a seal when the drainage catheter is introduced into the femoral vein 430 along the guidewire and dilator. The tailstock 333 can be connected to the connector of the extracorporeal circulation pump 100. The hemostatic valve 332 can be a detachable hemostatic valve 332, which can be quickly removed as needed, thus simplifying the surgical procedure.

[0075] The operation flowchart of the drainage catheter system of the present invention can be seen as follows: Figure 9As shown. In use, the drainage catheter passes through the atrial septum 450 to the left atrium 411 or the left superior pulmonary vein 413. The location of the atrial septum 450 is observed under angiography or ultrasound. The variable diameter segment 304 enters the perforation site to perform the first step of physical tearing and dilation. Subsequently, the second step of energy ablation can be performed at and around the perforation site of the atrial septum 450. During the second step of energy ablation, the ablation electrode 340 can be connected to the ablation host 500 through the electrode wire 305 embedded in the inner wall of the drainage tube 3031 to form a circuit, thereby releasing radiofrequency energy or pulsed electric field to destroy the atrial septum 450 tissue and fix the stoma edge to prevent stoma retraction or closure. By controlling the diameter of the variable diameter segment 304, the diameter of the atrial septum 450 stoma can be adjusted according to the treatment needs of different patients, selectively controlling the blood flow between the left atrium 411 and the right atrium 412.

[0076] It should be noted that in some other embodiments, the movable sleeve can be replaced with a fixed sleeve. In this case, the proximal end of the reducing section 304 can be fixed to the distal end of the fixed sleeve, and a traction rope can be installed inside the fixed sleeve. The traction rope connects to the distal end of the reducing section 304 to achieve control of the outer diameter of the reducing section 304. Alternatively, the reducing section 304 can be part of the drainage tube 3031. In this case, a traction rope or a drive rod can be installed inside the tube body 302 to drive the distal part of the reducing section 304 to move, thereby achieving control of the outer diameter of the reducing section 304. For example, the reducing section 304 can be located between the support section 310 and the bending section 320. The traction rope can pass through the tube wall of the support section 310, and the drive rod can pass through the lumen of the support section 310.

[0077] This invention combines left atrial drainage and atrial septal 450 stoma function. While meeting the short-term drainage requirements of the left atrium 411, the ablation electrode 340 can be used to destroy the atrial septal 450 tissue and fix the stoma edge without changing the device. The diameter of the atrial septal 450 stoma can also be adjusted, which helps to simplify the operation, reduce the difficulty of the operation, and prevent the stoma from retracting or closing, forming a shunt between the left and right atria 412 to improve left atrial pressure in the long term. It can also preserve the channel for subsequent short-term mechanical assisted circulation and avoid secondary mechanical injury to the patient.

[0078] An embodiment of the left ventricular drainage catheter in this invention:

[0079] The structure of the left ventricular drainage catheter 300 can be the same as that of the left ventricular drainage catheter 300 in any embodiment of the drainage catheter system described above, including an operating handle 301 and a tube body 302 connected to the operating handle 301; the tube body 302 includes a diameter-changing section 304, which includes an elastic skeleton 3041 and a flexible membrane 3045. The elastic skeleton 3041 is distributed circumferentially along the tube body 302, and the flexible membrane 3045 is connected to the elastic skeleton 3041. The gap between two adjacent elastic skeletons 3041 along the circumferential direction of the tube body 302 is closed by the flexible membrane 3045; the left ventricular drainage catheter 300 also includes a diameter-changing adjustment mechanism, which adjusts the diameter... The mechanism is used to bring the proximal and distal ends of the variable diameter section 304 closer together and further apart along the axial direction of the tube body 302, thereby causing a change in the outer diameter of the variable diameter section 304. The variable diameter section 304 also includes an ablation electrode 340 disposed on the elastic skeleton 3041 and / or the flexible membrane 3045. The tube body 302 also includes an electrode wire 305 connected to the ablation electrode 340, and the electrode wire 305 is disposed within the tube body 302. The operating handle 301 includes an electrical connection component 3011, the proximal end of the electrode wire 305 is connected to the electrical connection component 3011, and the electrical connection component 3011 is connected to the ablation host 500 to provide ablation energy to the ablation electrode 340. The specific structure of the left ventricular drainage catheter 300 will not be described in detail here.

[0080] The above examples illustrate the present invention only to aid in understanding it and are not intended to limit the scope of the invention. Those skilled in the art can make various simple deductions, modifications, or substitutions based on the principles of this invention.

Claims

1. A left ventricular drainage catheter, characterized in that, include: An operating handle and a tube body connected to the operating handle; The tube body includes a variable diameter section, and the variable diameter section is provided with an ablation electrode; The left ventricular drainage catheter also includes a diameter adjustment mechanism, which is used to move the proximal and distal ends of the diameter-changing section closer to each other and further apart along the axial direction of the tube body, so as to cause a change in the outer diameter of the diameter-changing section. The tube body also includes an electrode wire connected to the ablation electrode. The operating handle includes an electrical connection component. The proximal end of the electrode wire is connected to the electrical connection component. The electrical connection component is connected to the ablation host to provide ablation energy to the ablation electrode.

2. The left ventricular drainage catheter as described in claim 1, characterized in that, The variable diameter section includes an elastic skeleton and a flexible membrane. The elastic skeleton is distributed circumferentially along the tube body, and the flexible membrane is connected to the elastic skeleton. The gap between two adjacent elastic skeletons along the circumferential direction of the tube body is closed by the flexible membrane. The ablation electrode is disposed on the elastic skeleton and / or the flexible membrane.

3. The left ventricular drainage catheter as described in claim 1, characterized in that, The tube body is provided with a wire channel, which extends along the length of the tube body, and the electrode wire is disposed in the wire channel.

4. The left ventricular drainage catheter as described in claim 2, characterized in that, The variable diameter section includes a flexible circuit board connected to the surface of the elastic skeleton, and the ablation electrode is provided on the flexible circuit board.

5. The left ventricular drainage catheter as described in claim 4, characterized in that, The flexible circuit board includes conductive lines that are connected to the electrode wires to be electrically connected to the ablation electrode.

6. The left ventricular drainage catheter as described in claim 2, characterized in that, An electrode mounting groove is provided on the radially outer side of the elastic skeleton. At least a portion of the ablation electrode is embedded in the electrode mounting groove. A wire outlet hole is provided on the bottom wall of the electrode mounting groove, and the electrode wire is led out from the wire outlet hole.

7. The left ventricular drainage catheter as described in claim 1, 2, or 3, characterized in that, The tube body includes a drainage tube and a movable sleeve; the drainage tube has a drainage channel inside, and the distal end of the drainage tube has a drainage port communicating with the drainage channel; the movable sleeve is sleeved outside the drainage tube and can move along the drainage tube; the proximal end of the variable diameter section is fixed to the distal end of the movable sleeve, and the distal end of the variable diameter section is fixed to the drainage tube and located on the proximal side of the drainage port; the variable diameter adjustment mechanism is disposed on the operating handle, and the proximal end of the movable sleeve is connected to the output end of the variable diameter adjustment mechanism.

8. The left ventricular drainage catheter as described in claim 1, 2, or 3, characterized in that, The tube body includes a drainage tube and a fixed sleeve. The drainage tube has a drainage channel inside, and the distal end of the drainage tube has a drainage port communicating with the drainage channel. The fixed sleeve is sleeved outside the drainage tube and fixedly connected to the drainage tube. The proximal end of the variable diameter section is fixed to the distal end of the fixed sleeve. A pulling rope is installed inside the fixed sleeve. The distal end of the pulling rope is connected to the distal end of the variable diameter section, and the proximal end of the pulling rope is connected to the variable diameter adjustment mechanism.

9. The left ventricular drainage catheter as described in claim 7, characterized in that, The drainage tube includes a support section and a bending section. The bending section is connected to the distal end of the support section. The movable sleeve is fitted onto the support section. The distal end of the variable diameter section is located on the proximal side of the bending section.

10. A drainage catheter system, characterized in that, include: Left ventricular drainage catheter as described in any one of claims 1 to 9; And an ablation host, which is used to provide ablation energy to the ablation electrode.

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