Interventional medical devices

Abstract

This invention provides an interventional medical device comprising an interventional sheath, a catheter, and a pressure measuring assembly. The pressure measuring assembly measures blood pressure data of the human body using a first lavage fluid flowing through the gap between the interventional sheath and the catheter, providing monitoring of the patient's physiological state in interventional medical care. Furthermore, the invention provides an interventional catheter pump and its coupler, applicable to the interventional medical device, which provides mechanical circulatory support for the patient's cardiac pump function. The interventional catheter pump achieves pressure measurement of the first and second lavage fluids through a first and second chamber formed within the coupler and isolated from each other. Power supply, signal transmission, and power supply are achieved between the coupler and the driver through a coupling between them, significantly simplifying the coupler structure and reducing production difficulty and cost.

Description

Technical Field

[0001] This application claims the priority of a patent application with an application number of 202321991896.5 and an application title of "Interventional Medical Devices", which was filed with the China National Intellectual Property Administration on July 27, 2023.

[0002] This application relates to the technical field of medical devices, particularly to interventional medical devices.

Background Art

[0003] Interventional medical devices are devices that insert specific devices into the lesion of a patient through the natural pores or small incisions of the patient under the monitoring of imaging devices such as digital subtraction angiography, CT, ultrasonic devices, and magnetic resonance devices, using puncture needles, catheters, and other interventional equipment to diagnose the disease condition or perform minimally invasive treatment. In the process of performing interventional medicine, it is necessary to carefully monitor the vital sign data of the patient such as blood pressure and heart rate, but the current interventional medical devices lack corresponding designs.

[0004] Taking an interventional catheter pump, which is an example of a mechanical circulatory support (MCS) system, as an example, it is increasingly frequently used in the treatment of heart diseases such as heart failure. In the treatment of acute myocardial infarction (MI) or compensated heart failure, the interventional catheter pump can stabilize the patient after cardiogenic shock or provide support to the patient during the high-risk percutaneous coronary intervention (PCI) period.

[0005] In conventional technology, interventional catheter pumps can be powered by an external motor, which transmits rotational power to a distal impeller via a drive shaft that penetrates the catheter, causing the impeller to rotate and supply fluid power to the blood. In conventional technology, to understand the achievable auxiliary flow rate during the operation of the mechanical circulatory support system in real time, a pressure sensor is usually installed proximal to the impeller, and the flow rate due to the rotation of the impeller is estimated by an algorithm. However, such a structural design requires a separate lumen to be provided in the catheter for the sensor wires to pass through. This presents a significant challenge to the process and increases production costs.

[0006] Furthermore, the handle portion of conventional interventional catheter pumps must combine multiple functions, such as power generation and transmission, cleaning fluid supply, power supply, and signal transmission. This makes the overall structure increasingly complex, presenting further challenges to the design and production of interventional catheter pumps. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] To solve the above problems, this invention provides an interventional medical device that, instead of directly installing a blood-detecting sensor in the structure of the interventional part inside the body, utilizes the structure of the external part of the interventional medical device to install a corresponding pressure measuring assembly, thereby more conveniently measuring the blood pressure of the patient's arterial system and simplifying the structure of the interventional part of the device. [Means for solving the problem]

[0008] To achieve the above objective, the present invention provides an interventional medical device comprising an interventional sheath, a catheter, and a pressure measuring assembly, wherein the interventional sheath is operable such that its proximal end is located outside the subject's body and its distal end enters the subject's body, the catheter is operable such that its distal end enters the subject's body through the inside of the interventional sheath and has a gap between the catheter and the interventional sheath, and the pressure measuring assembly comprises an operating section connected to the proximal end of the catheter, located outside the subject's body and having a first chamber inside which is in fluid communication with the gap, a first conduit assembly which is in fluid communication with the first chamber and delivers a first cleaning fluid to the first chamber, and a first pressure sensor provided in the operating section which is in fluid communication with the first chamber and senses the liquid pressure inside the first chamber.

[0009] Furthermore, the first pipeline assembly includes a first liquid storage bag for storing the first cleaning fluid, a pressurizing device for pressurizing the first cleaning fluid, and a control valve for controlling the supply of the first cleaning fluid in the first liquid storage bag to the first chamber.

[0010] Furthermore, the pressurizing device includes a fluid pump, and both the fluid pump and the control valve are installed in the pipeline connecting the first liquid storage bag and the first chamber.

[0011] Furthermore, the pressurizing device includes a pressurizing bag, which includes a balloon fitted outside the first liquid storage bag and a pressurizing pump connected to the balloon via a pipeline, and the pressurizing pump fills the balloon with fluid to inflate the balloon and then presses against the first liquid storage bag to increase the pressure of the first washing liquid.

[0012] Furthermore, the pressure bag includes a pressure gauge, which is installed in the pipeline connecting the balloon and the pressure pump.

[0013] Furthermore, the pressurized bag includes a pressure relief valve, which is located in the balloon and releases the pressurized fluid inside the balloon.

[0014] Furthermore, the first pipeline assembly includes a first state in which the control valve is closed and a second state in which the control valve is open, wherein the liquid pressure in the first state within the first chamber is lower than the liquid pressure in the second state, and the time spent in the first state of the first pipeline assembly is longer than the time spent in the second state.

[0015] Furthermore, the operating section is further provided with a second chamber that is in fluid communication with the inside of the catheter, and the second chamber and the first chamber are sealed and separated from each other, and the interventional medical device further includes a second conduit assembly that is in fluid communication with the second chamber and delivers a second cleaning fluid to the second chamber.

[0016] Furthermore, the interventional medical device further includes a second pressure sensor located within the operating section, which is in fluid communication with the second chamber and senses the liquid pressure within the second chamber.

[0017] Furthermore, the second pipeline assembly includes a second liquid storage bag for storing the second cleaning fluid, a first liquid delivery pump for pumping the second cleaning fluid from the second liquid storage bag, a mixing device connected to the outlet of the first liquid delivery pump, the mixing device having fluid communication with the second chamber via a forward flow passage from the mixing device to the second chamber and a return flow passage from the second chamber to the mixing device, and a second liquid delivery pump for pumping the second cleaning fluid from the forward flow passage of the mixing device.

[0018] Furthermore, the interventional medical device further includes an operating unit connected to the distal end of the catheter, the operating unit performing a pre-set medical action.

[0019] Furthermore, the interventional medical device includes an interventional catheter pump, the interventional medical device includes a coupler which is at least part of the operating section, a pump case which is connected to the distal end of the catheter, and an impeller which is provided inside the pump case, the impeller which includes a pump head which is rotationally driven to draw blood from the inlet of the pump case and discharge blood from the outlet of the pump case, and a drive which is detachably connected to the coupler and includes a motor which drives the impeller.

[0020] Furthermore, the interventional medical device includes a circuit board provided within the coupler and electrically connected to a first pressure sensor, a first coupling terminal provided in the coupler and electrically connected to the circuit board, and a second coupling terminal provided in the driver. When the coupler and the driver are connected to each other, the first coupling terminal and the second coupling terminal are coupled to each other to form an electrical connection channel.

[0021] Furthermore, the interventional medical device further includes a drive shaft rotatably mounted inside the catheter and whose distal end is ductilely connected to an impeller, a drive member driven by a motor, and a driven member mounted inside the coupler and ductilely connected to the proximal end of the drive shaft, wherein one of the drive member and the driven member is a magnetic member, and the other is a magnetic member or a conductor, and the driven member and the drive member are coupled at a distance from each other with the coupler and the drive unit connected to each other, thereby enabling power transmission from the drive member to the driven member, the catheter extends inside the coupler and is in fluid communication with a second chamber, the driven member is located inside the second chamber, and the proximal end of the drive shaft extends from the proximal end of the catheter and enters inside the second chamber and is ductilely connected to the driven member.

[0022] Furthermore, the intervention sheath includes an intervention sheath catheter and a sheath base formed at the proximal end of the intervention sheath catheter, wherein the catheter includes a sheath base that penetrates from the proximal end of the sheath base, passes through the intervention sheath catheter, and extends from the distal end of the sheath base, and a side branch tube provided on the sheath base that is in fluid communication with the internal passage of the intervention sheath catheter, the side branch tube having one end connected to a port on the sheath base and communicating with the gap between the catheter and the intervention sheath catheter, and the other end communicating with the first chamber.

[0023] Furthermore, the sheath base is equipped with a sewn buckle, which secures the device in place.

[0024] Furthermore, the coupler is provided with a first chamber, a first joint, and a second joint that communicate with the first chamber. The first joint communicates with the first liquid storage bag of the first pipeline assembly, and the second joint communicates with the side branch pipe.

Advantages of the Invention

[0025] The interventional medical device according to the present application uses the gap between the catheter and the interventional sheath as a passage that communicates with the human body's blood circulation system and the first chamber, and provides a chamber in the operation part through which the first cleaning liquid flows, so as to integrate the first pressure sensor for measuring the pressure of the first cleaning liquid in the operation part. Thereby, by providing the sensor outside the body, in-vivo blood tests can be realized. Furthermore, there is no need to design a lumen for wiring in the catheter, simplifying the structure of the catheter, omitting the attachment of conducting wires, and reducing the manufacturing difficulty and production cost.

Brief Description of the Drawings

[0026] The attached drawings forming a part of the present application are for providing a further understanding of the present invention, and the schematic embodiments and their descriptions of the present invention are for interpreting the present invention and do not unduly limit the present invention.

[0027] [Figure 1] It is a schematic configuration diagram of an interventional medical device according to an embodiment of the present application. [Figure 2] It is a schematic configuration diagram of an interventional medical device according to another embodiment of the present application. [Figure 3] It is a schematic configuration diagram of another embodiment of the pressurizing device of the first liquid storage bag in FIG. 1 or FIG. 2. [Figure 4] It is a schematic configuration diagram of the appearance in which the side branch pipe of the interventional catheter pump communicates with the coupler and the interventional sheath.

Modes for Carrying Out the Invention

[0028] Hereinafter, various exemplary embodiments of the present application will be described in detail with reference to the drawings. The description of exemplary embodiments is illustrative only and does not constitute any limitation on the present application or its application or use. The present application may be realized in many different forms and is not limited to the embodiments described herein. These embodiments are provided to thoroughly and completely disclose the present application and to fully convey the scope of the present application to those skilled in the art. Unless otherwise specified, the relative arrangements of components and steps, material compositions, formulas and numerical values ​​described in these embodiments are illustrative only and not limiting.

[0029] In this embodiment, the terms "proximal" and "distal" are used relative to the clinician operating the device. The term "proximal" refers to the part closest to the clinician, and the term "distal" refers to the part located further away from the clinician. The proximal end of a part / assembly indicates the end that is relatively close to the clinician, and the distal end indicates the end that is relatively far away from the clinician.

[0030] In the course of interventional examinations or treatments, intervention sheaths are often used in combination with catheters. Intervention sheaths primarily serve to enlarge percutaneous incisions and assist in the entry of catheters into the patient's blood vessels. In clinical use, a small incision is first made in the skin at the puncture site using a scalpel, then the puncture site is punctured with a puncture needle and a guidewire is passed along the needle tube, then the intervention sheath with a dilator is inserted from the end of the guidewire and delivered to the blood vessel, and finally the dilator is removed, thereby delivering the tip of the intervention sheath to the first desired location inside the patient's body and establishing a percutaneous access route for the intravascular device.

[0031] Based on the percutaneous access route for the intravascular device established by the intervention sheath, the catheter penetrates the inside of the intervention sheath and enters the blood vessels of the human body, reaching a second desired location within the patient's body through the guidance of the guidewire.

[0032] Depending on the different purpose of the intervention, examination, or treatment, catheters have different functions.

[0033] For example, in an interventional examination, angiographic imaging diagnosis may be performed by delivering a contrast agent to a specific location in the body via a catheter, or a pathological diagnosis may be performed by puncturing a local lesion via a catheter and collecting tissue.

[0034] Furthermore, in interventional therapy, for example, drugs or embolizing agents may be injected into the lesion area in the body via a catheter, devices such as stents may be placed at a designated location in the body via a catheter, or a drive shaft may be provided via a catheter to power the body's blood pump and assist the heart's blood pumping function.

[0035] The operating parts, as described later, often differ depending on the purpose. The operating parts change according to different scenes and can achieve the purpose of the corresponding scene. For example, in interventional therapy, the operating parts may be a pump head with a blood pumping function, as described later, or a vascular stent capable of dilating blood vessels.

[0036] For some of the intervention tests or treatments described above, the intervention sheath and catheter are the structural basis for achieving specific medical objectives. Because the catheter needs to pass through the intervention sheath and enter the human body percutaneously, there is always a certain gap between the intervention sheath and the catheter. Also, because the distal ends of the intervention sheath and catheter enter the body's blood circulation system, blood can easily enter the gap between the intervention sheath and the catheter, increasing the risk of thrombosis. The risk of thrombosis is clear and includes, but is not limited to, cases where a thrombus travels throughout the body via the bloodstream and enters the brain, inducing a stroke, or where a thrombus remains in a specific part of a blood vessel without traveling, obstructing oxygen supply to nearby nerve tissue and causing nerve damage.

[0037] Simultaneously, during intervention tests and treatments, physicians need to monitor vital signs data of the patient in real time, particularly blood pressure indicators that can represent the functioning status of the circulatory system. In particular, in mechanical circulatory support systems, such as intervention catheter pumps, it is desirable to know the achievable support flow rate when the impeller is operating in real time. One way to achieve this is to measure aortic blood pressure and then calculate it using an algorithm; therefore, accurately obtaining aortic blood pressure is extremely important.

[0038] Based on the structural basis of the intervention sheath and catheter described above, and the need to accurately obtain aortic blood pressure, as shown in Figures 1 and 2, this embodiment provides an intervention medical device including a pressure measuring assembly, which performs a pre-set medical action by an operating unit connected to the distal end of the catheter 2, and measures the patient's blood pressure outside the body by utilizing the gap between the intervention sheath 1 and the catheter 2 using the pressure measuring assembly 4.

[0039] The pressure measurement assembly 4 includes an operating unit 41 connected to the proximal end of the catheter 2, which is located outside the subject's body and contains a first chamber 411 that is in fluid communication with the gap between the intervention sheath 1 and the catheter 2. Based on the first chamber 411, the pressure measurement assembly 4 further includes a first conduit assembly 42 that is in fluid communication with the first chamber 411 in order to deliver a first lavage fluid to the first chamber 411. This allows the first lavage fluid to flow from the first conduit assembly 42 into the first chamber 411, achieving a lavage action on the gap between the catheter 2 and the intervention sheath 1, and effectively avoiding thrombus formation. Based on this, the present invention provides a first pressure sensor 43 within the operating unit 41 that senses the fluid pressure in the first chamber 411 and converts blood pressure data in the human body based on the pressure of the first lavage fluid in the first chamber 411.

[0040] The principle for converting blood pressure data from the pressure of the first irrigation solution is that, in a sealed tubing system, the pressure at each interconnected point in the tubing system is equal. Specifically, the intervention sheath 1 and catheter 2, once inside the human body, have their distal ends entering the blood circulation system and their proximal ends fluidly communicating with the first chamber 411 within the operating section 41. Therefore, the first chamber 411, the gap between the intervention sheath 1 and catheter 2, and the blood circulation system inside the human body form a sealed tubing system that communicates with each other. By sensing the liquid pressure inside the first chamber 411 with the first pressure sensor 43, blood pressure data can be obtained.

[0041] In this invention, since the first pressure sensor 43 is located inside the external operating unit 41, there is no need to arrange wires inside the catheter 2, compared to technical means in which the pressure sensor is located inside the body. Therefore, the complexity of the structure, the difficulty of the process, and the manufacturing cost of the pressure measurement system are significantly reduced.

[0042] Furthermore, it has been clinically proven that by not placing the wires connecting the sensors inside catheter 2, the diameter of catheter 2 can be significantly reduced, thereby reducing the size of the intervention device. A smaller diameter for catheter 2 also means a correspondingly smaller diameter for the corresponding intervention sheath 1. Thus, it is not necessary to maintain a significantly dilated state of the patient's puncture site after the intervention by the operating unit is complete. Reducing the intervention size and preventing the puncture site from being dilated for extended periods by a large device is extremely beneficial for reducing patient discomfort, avoiding complications, and facilitating rapid postoperative recovery.

[0043] The first pressure sensor 43 is located in the first chamber 411, allowing blood pressure measurement to be performed at the distal end of the intervention sheath 1 and catheter 2 as they enter the blood circulation system through the gap between the intervention sheath 1 and catheter 2, thereby bringing the blood pressure measurement location closer to the target area of ​​the intervention examination or treatment. Therefore, compared to non-interventional extracorporeal blood pressure measurement, the blood pressure measurement results are closer to the actual blood pressure in the target area, thereby providing more accurate and detailed blood pressure data for the intervention examination or treatment.

[0044] The first tubing assembly 42 includes a first fluid storage bag 421, a pressurizing device 422, and a control valve 423. The first fluid storage bag 421 stores the first cleaning fluid, and the control valve 423 controls the passage or non-passage of the first cleaning fluid to the first chamber 411 in real time, and may adjust the flow rate of the first cleaning fluid in the first fluid storage bag 421 to the first chamber 411. The pressurizing device 422 acts on the first fluid storage bag 421 and pressurizes the first cleaning fluid in the first fluid storage bag 421 to a set pressure value, thereby satisfying the pressure requirements for the first cleaning fluid in the human blood circulation system and the gap between the intervention sheath 1 and the catheter 2.

[0045] The pressurizing device 422 may be any structure capable of providing a pressure-boosting effect to the first cleaning fluid. For example, in one optional embodiment, the pressurizing device 422 may be a fluid pump, such as a peristaltic pump, as shown in Figure 1 or Figure 2, and is installed in a conduit connecting the first liquid storage bag 421 and the first chamber 411. Alternatively, in another optional embodiment, the pressurizing device 422 is a pressure bag, as shown in Figure 3, and includes a balloon 424 placed over the first liquid storage bag 421 and a pressure pump 425 connected to the balloon via a conduit. The pressure pump 425 may be a manual or electric pressure pump and achieves a pressure increase in the first cleaning fluid by filling the balloon 424 with fluid, inflating the balloon 424, and then pressing the first liquid storage bag 421. A pressure gauge 426 may be provided in the conduit connecting the balloon and the pressure pump to facilitate real-time observation of the pressure value. The balloon 424 is provided with a pressure relief valve that releases the pressurized fluid inside the balloon, such as gas, to relieve pressure in the pressurized bag. The control valve 423 is located in the conduit connecting the first liquid storage bag 421 and the first chamber 411, and may be any suitable existing structure such as a solenoid valve or tube clamp.

[0046] In this embodiment, the first pipeline assembly 42 is required not only to provide a transport pumping function for the first cleaning fluid, but also to assist the pressure sensing function of the first pressure sensor 43. When measuring the pressure during pumping of the first cleaning fluid, it should be understood that the pressure measurement is closer to the output pressure of the pressurizer 422 of the first pipeline assembly 42 than to the blood pressure of a human body. Therefore, in this application, the state in which the first pipeline assembly 42 delivers the first cleaning fluid to the first chamber 411 is configured to include at least a first state and a second state.

[0047] Specifically, the pressure of the first lavage fluid in the first state is lower than the pressure in the second state. Furthermore, the pressure of the lavage fluid in the first state is approximately equal to the blood pressure of the human body under steady conditions, while the pressure of the lavage fluid in the second state is greater than the blood pressure of the human body. As a result, the first lavage fluid passes through the gap between the intervention sheath 1 and catheter 2 at a higher pressure and flows into the human blood system, thoroughly lavaging the gap between the intervention sheath 1 and catheter 2, washing away any blood that has penetrated the gap, and reducing or preventing thrombus formation.

[0048] As can be understood from the above technical description, the first state is when the control valve 423 is closed, and the second state is when the control valve 423 is open. When the control valve 423 is opened, the pressure of the lavage fluid is higher than the blood pressure of the human body, so the first lavage fluid flows out rapidly from the gap between the intervention sheath 1 and the catheter 2, washing away the blood accumulated in the gap and preventing the blood from remaining in the gap for a long time and forming a thrombus. After lavage for a predetermined time, the control valve 423 is closed. At the moment the control valve 423 is closed, the pressure of the lavage fluid in the gap is still higher than the blood pressure, so the lavage fluid in the gap continues to flow out from the distal end. The pressure of the lavage fluid in the gap gradually decreases as the lavage fluid flows out, and when it becomes approximately equal to the blood pressure, the outflow stops and the pressure stabilizes. Since the first chamber 411 is in fluid communication with the blood circulation system of the human body through the gap, the pressure in the first chamber 411 measured by the first pressure sensor 43 is approximately the blood pressure of the human body.

[0049] The pressurizing device 422 and the control valve 423 further control the first lavage fluid so that the time it spends in the first state is longer than the time it spends in the second state. As can be understood in this regard, during the course of interventional examination or treatment, the first lavage fluid can be selected as heparinized saline or another similar fluid to reduce the impact of the first lavage fluid entering the human body and affecting the circulatory system. However, in order to prevent disrupting the original equilibrium of the human body's circulatory system, excessive entry of the first lavage fluid into the human body should be avoided as much as possible. Therefore, the method of lavage between the intervention sheath 1 and the catheter 2 may be intermittent rather than continuous. For example, in one embodiment, the control valve 423 is opened and lavage is continued for a predetermined time of 2-3 seconds (or even shorter), and then the control valve 423 is quickly closed.

[0050] In the above embodiment, the first state is considered to be the normal state of the first conduit assembly 42, and the second state is considered to be the cleaned state of the first conduit assembly 42. However, with technological advancements and the needs of actual examination or treatment, the first state may be further divided into several more specific states for interventional medical devices. In contrast, the relationship between time and pressure as limited to this application is not limited to the first and second states in the above embodiment.

[0051] In this embodiment, the limitation that the liquid pressure in the second state is higher than that in the first state is to ensure that the first cleaning fluid has sufficient kinetic energy to clean the gap between the intervention sheath 1 and the catheter 2, and the limitation that the time the cleaning fluid is in the second state is shorter than the time it is in the first state is to reduce the possibility of the first cleaning fluid entering the blood circulation system in excess and affecting the equilibrium within the human body. Based on this concept, those skilled in the art can adjust the liquid pressure and time in the first and second states according to their actual needs, and this embodiment is not limited to this.

[0052] As shown in Figure 2, in another embodiment, a second chamber 44 is further provided inside the operating unit 41, and the second chamber 44 and the first chamber 411 are sealed and separated from each other and do not communicate with each other. The second conduit assembly 45 is in fluid communication with the second chamber 44 and delivers the second cleaning fluid to the second chamber 44. The pressure measuring system further includes a second pressure sensor 46, which is also provided inside the operating unit 41 and senses the pressure in the second chamber 44, thereby assisting in obtaining the real-time injection pressure of the second cleaning fluid and providing assistance for interventional examination or treatment.

[0053] The second chamber 44 and the corresponding second tubing assembly 45 are used to pump the second cleaning fluid into the catheter 2, which flows along the catheter 2 toward the distal end, further lubricating and cooling the inside of the catheter 2 and the rotating members of the working part. In particular, when the technical means of this embodiment are applied to an intervention catheter pump, the rotating member in the catheter 2 is the flexible drive shaft 202, and the rotating member of the working part is the proximal end bearing and distal end bearing that support the rotation of the impeller 522. For the technical means by which the second chamber 44, in conjunction with the second tubing assembly 45, achieves the above lubrication and cooling, refer to the description in Chinese Patent ZL202211578294.7, and a detailed description is omitted here.

[0054] The first pressure sensor 43 and the second pressure sensor 46 are both located within the operating unit 41. By utilizing the first chamber 411 and the second chamber 44, which are separated from each other within the operating unit 41 and do not have fluid communication with each other, the first pressure sensor 43 can sense the blood pressure of the human body based on the first chamber 411, and the second pressure sensor 46 can sense the pressure of the second washing fluid based on the second chamber 44. As a result, the pressure measurement system of the present invention can accurately sense the pressure of extracorporeal fluids and internal blood involved in intervention examinations or treatments, improving the immediacy and accuracy of pressure data acquisition during intervention examinations or treatments. Furthermore, by providing both the first pressure sensor 43 and the second pressure sensor 46 within the operating unit 41, the integration of the pressure measurement system is further improved, and the structural design is rational.

[0055] The second pipeline assembly 45 includes a second liquid storage bag 451, a first liquid transfer pump 452, a mixing device 453, and a second liquid transfer pump 454. The second liquid storage bag 451 stores the second cleaning fluid, and the first liquid transfer pump 452, which may be a peristaltic pump, is installed in the pipeline connecting the second liquid storage bag 451 and the mixing device 453 and continuously pumps the second cleaning fluid from the second liquid storage bag 451. The mixing device 453 is connected to the outlet of the first liquid transfer pump 452 and is provided with a forward flow passage from the mixing device 453 to the second chamber 44 and a return flow passage from the second chamber 44 to the mixing device 453. The second liquid transfer pump 454, which may also be a peristaltic pump, pumps the second cleaning fluid from the forward flow passage of the mixing device 453.

[0056] The second cleaning fluid is pumped from the second storage bag 451 by the action of the first fluid delivery pump 452 and the second fluid delivery pump 454 and supplied to the second chamber 44 via the forward flow passage of the mixing device 453. To ensure that the flow rate of the second cleaning fluid injected into the human body in the second chamber 44 meets the demand, a return passage is further provided between the mixing device 453 and the second chamber 44. This allows a portion of the second cleaning fluid pumped into the second chamber 44 to enter the human body via the catheter 2, while the remainder returns to the mixing device 453 via the return passage. Since the flow rate of the second cleaning fluid passing through the catheter 2 is determined by the flow area of ​​the catheter 2, providing a return passage ensures that the flow rate of the fluid entering the human body via the second chamber 44 does not become excessive.

[0057] As shown in Figures 1, 2, and 4, in one specific embodiment, the interventional medical device is an interventional catheter pump, which includes a coupler 51, a pump head 52, and a drive unit 53. The pump head 52 includes a pump case 521 connected to the distal end of the catheter 2 and an impeller 522 provided inside the pump case 521. The impeller 522 is rotationally driven to draw blood from the inlet of the pump case 521 and discharge blood from the outlet of the pump case 521. The coupler 51 and the drive unit 53 are detachably connected to each other, and the connection between them enables power transmission from the drive unit 53 to the coupler 51, which in turn drives the rotation of the impeller 522.

[0058] Similarly, the relevant structure of the intervention catheter pump and the non-contact coupling method between the coupler 51 and the driver 53 can be described in Chinese Patent ZL202211578294.7, and are omitted here.

[0059] As a result, the coupler 51 of the intervention catheter pump may be used as at least part of the operating section 41 of the intervention medical device, and the pump head 52 may be used as at least part of the working section of the intervention medical device, and the blood flow generated by the rotation of the impeller 522 can be used to support the pumping function of the patient's heart. The intervention medical device can perform various treatment or examination operations according to the patient's needs, for example, to simultaneously administer a drug to the patient and place a stent, or to simultaneously perform contrast-enhanced diagnosis and mechanical circulatory support to the patient. In this case, the operating section 41 and working section of the intervention medical device may each include operating members and working members corresponding to different applications, and different medical operations can be completed by using an intervention medical device constructed with the same set of intervention sheath 1, catheter 2 and pressure measuring assembly 4, saving material costs for interventional medicine, saving medical time, and reducing patient discomfort.

[0060] Furthermore, the term "simultaneously" above does not limit the use of different types of interventional medical treatments to those performed at the same time, but rather means the use of interventional medical devices constructed from the same set of interventional sheath 1, catheter 2, and pressure measurement assembly 4. Naturally, different types of interventional medical treatments can be performed on a patient at the same time, and in such cases, the pressure measurement assembly 4 according to this application can still accurately and timely acquire blood pressure data from within the patient's body, providing support for physicians to monitor the patient's physiological state and formulate medical strategies.

[0061] A circuit board is provided inside the coupler 51, a first coupling terminal is provided at the proximal end of the coupler 51, and a second coupling terminal is provided at the distal end of the driver 53. When the coupler 51 and the driver 53 are connected to each other, the first coupling terminal and the second coupling terminal are connected to form an electrical coupling channel. The circuit board is electrically connected to the first pressure sensor 43 and the second pressure sensor 46, while also being electrically connected to the first coupling terminal. As a result, an electrical coupling path is formed inside the coupler 51 from the first pressure sensor 43 and the second pressure sensor 46 to the circuit board and further to the first coupling terminal, and an electrical coupling path is formed outside the coupler 51 from the first coupling terminal to the second coupling terminal.

[0062] When the coupler 51 and the driver 53 are connected to each other, the first coupling terminal and the second coupling terminal are connected to form an electrical coupling channel. In this embodiment, by connecting the electrical coupling path inside the coupler 51 to the driver 53, electrical energy is supplied to the coupler 51 using the driver 53, thereby preventing leakage of the first or second cleaning fluid inside the coupler 51 from adversely affecting the electrical coupling path.

[0063] The electrical connection channels formed between the circuit board and the first pressure sensor 43, the second pressure sensor 46, and the first coupling terminal, and the electrical connection channels formed between the first coupling terminal and the second coupling terminal, can not only transmit electrical energy to operate the electronic components but also transmit corresponding sensing signals or control signals. That is, via the electrical connection paths, the first pressure sensor 43 and the second pressure sensor 46 can transmit the sensed pressure signals of the first chamber 411 and the second chamber 44 to the circuit board, and further transmit them to the driver 53 via the first coupling terminal and the second coupling terminal. The wired communication formed by the electrical connection paths can effectively improve the reliability and real-time nature of the communication, which is crucial for ensuring the safe operation of the interventional medical device and the life and health of the patient.

[0064] As shown in Figure 4, the coupler 51 is provided with a first joint 511 and a second joint 512 that communicate with the first chamber 411. The first joint 511 communicates with the first fluid storage bag 421 via a conduit, and the second joint 512 communicates with the gap between the intervention sheath 1 and the catheter 2 via a side branch pipe 7. Based on the circumferential positional relationship between the intervention sheath 1 and the catheter 2, the first conduit assembly 42 supplies the liquid from the first fluid storage bag 421 to the first chamber 411 along the illustrated liquid inflow direction. Subsequently, the first cleaning fluid in the first chamber 411 enters the side branch pipe 7 of the intervention sheath 1 along the illustrated liquid outflow direction and finally flows to a first desired position through the gap between the intervention sheath 1 and the catheter 2. The second cleaning fluid in the second chamber 44 flows to a second desired position through the catheter 2.

[0065] The first desired position varies depending on the specific application scenario of the catheter pump. For example, when the catheter pump is used as left ventricular support, the first desired position is a location within the left ventricle, and the second desired position is a location within the aorta. On the other hand, when the catheter pump is used as right ventricular support, the first desired position is generally a location within the pulmonary veins, and the second desired position is a location within the right ventricle.

[0066] As shown in Figures 1 and 2, a drive shaft 202 is provided inside the catheter 2. Preferably, the drive shaft 202 is a flexible drive shaft that bends together with the catheter 2 within the vascular system of the human body and enters the desired position within the human body. A pump case 521 is connected to the distal end of the catheter 2, and an impeller 522 is provided inside the pump case 521. When the pump case 521 reaches the desired position within the human body, for example, the left ventricle, it unfolds, and the impeller 522 inside is driven by rotational power transmitted from the drive shaft 202, drawing blood into the left ventricle from the inlet of the pump case 521 and discharging it into the aorta from the outlet of the pump case 521, thereby assisting the pumping function of the heart.

[0067] The above describes a foldable catheter pump, in which both the pump case 521 and the impeller 522 are foldable. However, the application scenarios of the technical means of this embodiment are not limited to this. In fact, non-foldable catheter pumps can also be similarly applied to the technical means of this application. Similarly, the catheter pump is an external power unit. Based on the above, the catheter pump may use a structure in which the power unit is built in. In this case, the power unit, for example, a motor, is connected to the distal end of the catheter 2, eliminating the need for an elongated flexible drive shaft 202 to pass through the catheter 2, and the power unit drives the impeller 522 by means of a rigid short shaft or magnetic coupling.

[0068] In the intervention catheter pump, the first lavage fluid flows into the first desired location in the human body through the gap between the catheter 2 and the intervention sheath 1, thereby achieving a lavage action in the gap between the catheter 2 and the intervention sheath 1 and preventing thrombus formation. Furthermore, since the lavage in the gap between the catheter 2 and the intervention sheath 1 by the first lavage fluid is performed intermittently, when the first lavage fluid is performing lavage, the first pressure sensor 43 can sense the pressure of the first lavage fluid, and when the first lavage fluid is not performing lavage, the first pressure sensor 43 can sense the blood pressure in the human body due to the equilibrium established between the first lavage fluid in the gap between the catheter 2 and the intervention sheath 1 and the blood pressure in the human body. In the scenario where the catheter pump is used as left ventricular support, the above blood pressure is specifically the blood pressure in the aorta. Since the blood outlet of the pump head 52 is located in the aorta, the above blood pressure largely reflects the pumping pressure that the pump head 52 applies to the blood.

[0069] Meanwhile, the second cleaning fluid flows from the catheter 2 to a second desired location inside the human body, thereby providing lubrication and cooling to the catheter 2, the drive shaft rotating inside it, and the proximal and distal end bearings. The second pressure sensor 46 may sense the pressure of the second cleaning fluid in real time.

[0070] The intervention catheter pump further includes a drive member driven by a motor and a driven member provided inside the coupler 51 and ductilely connected to the proximal end of the drive shaft. With the coupler 51 and the power unit connected to each other, the driven member and the drive member are coupled to each other at a distance, thereby enabling power transmission from the drive member to the driven member. Through the transmission connection between the driven member and the drive shaft 202, the power of the motor is transmitted to the impeller 522 via the drive member, the driven member and the drive shaft 202, causing the impeller 522 to rotate and pump blood.

[0071] Since power is transmitted non-contact between the driving member and the driven member, it is possible to effectively prevent the second cleaning fluid from entering the inside of the drive unit 53 and affecting electrical elements such as the motor. Specifically, the catheter 2 extends into the inside of the coupler 51 and is in fluid communication with the second chamber 44, the driven member is located inside the second chamber 44, the proximal end of the driving shaft extends from the proximal end of the catheter 2 and enters the inside of the second chamber 44 and is movably connected to the driven member, and the driven member is movably connected to the driving shaft inside the second chamber 44. This further confines the second cleaning fluid to the inside of the second chamber 44 of the coupler 51 and the catheter 2, preventing the second cleaning fluid from flowing into other parts of the coupler 51 and causing adverse effects.

[0072] The intervention sheath 1 may utilize any suitable existing structure from known embodiments provided in publication number CN115227962A. As shown in Figure 4, the intervention sheath 1 generally includes an elongated intervention sheath catheter 11, a sheath base 6 formed at the proximal end of the intervention sheath catheter 11, and a side branch tube 7 provided on the sheath base 6 and in fluid communication with the internal passage of the intervention sheath catheter 11. The catheter 2 penetrates from the proximal end 63 of the sheath base 6, further penetrates the intervention sheath catheter 11, and exits from its distal end. One end of the side branch tube 7 communicates with the sheath base 6 via a port 64, and further communicates with the gap formed between them after the catheter 2 has penetrated the intervention sheath, and the other end communicates with the first chamber 411. Throughout the operation of the pump head 52, the intervention sheath 1 is secured to the patient's skin by a suture buckle 62 provided on the sheath base 6, thereby achieving fixation.

[0073] Furthermore, in order to achieve a seal and prevent leakage of liquids or blood, a sealing structure is provided within the sheath base 6. Specifically, this can be described by referring to the known embodiments described above, and will not be explained here.

[0074] The coupler 51 is connected to the catheter 2 and functions as an intermediate structure, supplying the second irrigation fluid to the catheter 2, supplying the first irrigation fluid to the gap between the catheter 2 and the intervention sheath 1, and further supplying the first irrigation fluid and blood pressure measurement data through the gap between the catheter 2 and the intervention sheath 1. The coupler 51 and the driver 53 are matched and connected to each other, thereby realizing the coupling of three elements: electrical energy, communication signals, and rotational drive.

[0075] The coupler 51 includes a housing and a first chamber 411 and a second chamber 44 provided within the housing. The first chamber 411 receives a first cleaning fluid and delivers it into the gap between the catheter 2 and the intervention sheath 1. The second chamber 44 and the first chamber 411 are spaced apart from each other and receive a second cleaning fluid and deliver it into the interior of the catheter 2.

[0076] Based on the structure of the first chamber 411 and the second chamber 44, which are separated from each other within the coupler 51, the first pressure sensor 43 and the second pressure sensor 46 are installed inside the housing, respectively, to measure the pressure in the first chamber 411 and the second chamber 44.

[0077] As described above, the first cleaning fluid in the first chamber 411 has at least two states. Therefore, the first pressure sensor 43 measures the pressure of the first cleaning fluid in the cleaning state and the blood pressure in the non-cleaning static state. The second pressure sensor 46 can obtain the injection pressure of the second cleaning fluid into the human body by measuring the pressure of the second cleaning fluid in the second chamber 44.

[0078] The coupling method between the driving member and the driven member may be magnetic coupling, in which case both are magnetic members. Alternatively, the coupling method between the driving member and the driven member may be eddy current coupling, in which case both are a magnetic member and a conductor, respectively.

[0079] Based on the coupling connection between the first coupling terminal and the second coupling terminal, and the coupling connection between the driven member and the driving member, power supply, signal transmission, and power supply inside the coupler 51 can all be provided non-contact by an external power unit, forming an independent sealed space inside the coupler 51 and avoiding adverse effects on power supply, signal transmission, and power supply due to leakage of the first cleaning fluid and the second cleaning fluid.

[0080] The catheter 2 extends into the coupler 51 and is in fluid communication with the second chamber 44, the driven member is located inside the second chamber 44, and the proximal end of the drive shaft extends from the catheter 2 into the second chamber 44 and is movably connected to the driven member. Based on this, the driven member is movably connected to the connecting shaft inside the second chamber 44, thereby further confining the second cleaning fluid to the second chamber 44 and the catheter 2 of the coupler 51, and preventing the second cleaning fluid from flowing into other parts of the coupler 51 and causing adverse effects.

[0081] As described above, the interventional medical device according to the present invention utilizes two states: the gap between the catheter 2 and the intervention sheath 1, and the state of the first washing fluid within the gap. By washing the gap between the catheter 2 and the intervention sheath 1 in the washing state of the first washing fluid, thrombus formation can be avoided. In the non-washing state of the first washing fluid, the gap between the catheter 2 and the intervention sheath 1 can be used as a conduit to communicate with the human body's blood circulation system and the first chamber 411, thereby enabling accurate measurement of the human body's blood pressure.

[0082] Furthermore, in this invention, a chamber through which the first cleaning fluid flows is provided inside the coupler 51 of the intervention catheter pump, and a first pressure sensor 43 for measuring the pressure of the first cleaning fluid is integrated inside the coupler 51. By placing the sensor outside the body, the structure of the catheter 2 and the attachment of the conductors are simplified, thereby reducing manufacturing difficulty and production costs.

[0083] The embodiments disclosed herein are as described above, but these are merely embodiments intended to facilitate understanding of the present application and do not limit it. Those skilled in the art can make any modifications and changes to the embodiments and details without departing from the spirit and scope of the present application. [Explanation of Symbols]

[0084] 1. Intervention Sheath 11. Intervention sheath catheter 2 Catheter 202 Drive shaft 4. Pressure Measurement Assembly 41 Operation section 411 Chamber 1 42. First pipeline assembly 421 First fluid storage bag 422 Pressurizing device 423 Control valve 424 Balloons 425 Pressure pump 426 Pressure gauge 43. First pressure sensor 44. Chamber 2 45. Second pipeline assembly 451 Second liquid storage bag 452 First liquid transfer pump 453 Mixing equipment 454 Second liquid transfer pump 46. ​​Second pressure sensor 51 Coupler 511 First Joint 512 Second Joint 52 Pump Heads 521 Pump Case 522 Impeller 53 Drive unit 6. Sheath Base 62. Sewn buckle 63 Proximal end 64 ports 7 Side branch pipe

Claims

1. An intervention medical device comprising an intervention sheath, a catheter, and a pressure measuring assembly, The intervention sheath is operable so that its proximal end is located outside the subject's body and its distal end is located inside the subject's body. The catheter is operable so that its distal end enters the body of the subject through the inside of the intervention sheath, and has a gap between the catheter and the intervention sheath. The pressure measuring assembly is An operating unit connected to the proximal end of the catheter, located outside the subject's body, and having a first chamber inside that is in fluid communication with the gap, A first pipeline assembly that is in fluid communication with the first chamber and supplies the first cleaning liquid to the first chamber, An interventional medical device characterized by including a first pressure sensor provided within the operating section, which is in fluid communication with the first chamber and senses the liquid pressure in the first chamber.

2. The first conduit assembly is A first liquid storage bag for storing the first cleaning solution, A pressurizing device for pressurizing the first cleaning solution, The interventional medical device according to claim 1, further comprising a control valve for controlling the supply of the first cleaning solution in the first liquid storage bag to the first chamber.

3. The interventional medical device according to claim 2, characterized in that the pressurizing device includes a fluid pump, and both the fluid pump and the control valve are provided in a conduit connecting the first liquid storage bag and the first chamber.

4. The pressurizing device includes a pressurizing bag, the pressurizing bag includes a balloon fitted outside the first liquid storage bag and a pressurizing pump connected to the balloon via a conduit, and the pressurizing pump fills the balloon with fluid to inflate the balloon and then presses the first liquid storage bag to increase the pressure of the first washing liquid, as described in claim 2.

5. The interventional medical device according to claim 4, characterized in that the pressure bag includes a pressure gauge, and the pressure gauge is provided in a conduit connecting the balloon and the pressure pump.

6. The interventional medical device according to claim 4, wherein the pressure bag includes a pressure relief valve, the pressure relief valve is provided in the balloon and releases the pressurized fluid inside the balloon.

7. The interventional medical device according to claim 2, wherein the first piping assembly includes a first state in which the control valve is closed and a second state in which the control valve is open, the liquid pressure in the first state in the first chamber is lower than the liquid pressure in the second state, and the time spent in the first state of the first piping assembly is longer than the time spent in the second state.

8. The interventional medical device according to claim 1, further comprising a second chamber inside the operating section that is in fluid communication with the inside of the catheter, the second chamber and the first chamber being sealed and separated from each other, and the interventional medical device further comprising a second conduit assembly that is in fluid communication with the second chamber and delivers a second cleaning fluid to the second chamber.

9. The interventional medical device according to claim 8, further comprising a second pressure sensor provided in the operating section, which is in fluid communication with the second chamber and senses the liquid pressure in the second chamber.

10. The second conduit assembly is A second liquid storage bag for storing the second cleaning solution, A first liquid transfer pump for pumping the second cleaning solution from the second liquid storage bag, A mixing device connected to the outlet of the first liquid transfer pump, the mixing device having fluid communication with the second chamber via a forward flow passage from the mixing device to the second chamber and a return flow passage from the second chamber to the mixing device, The interventional medical device according to claim 8, further comprising a second liquid delivery pump for pumping the second cleaning solution from the forward flow passage of the mixing device.

11. The interventional medical device according to claim 10, further comprising an operating unit connected to the distal end of the catheter, wherein the operating unit performs a preset medical action.

12. The intervention medical device includes an intervention catheter pump, A coupler which is at least a part of the operating section, The pump case is connected to the distal end of the catheter, and an impeller is provided inside the pump case, the impeller being rotationally driven to draw blood from the inlet of the pump case and discharge blood from the outlet of the pump case, The interventional medical device according to claim 10, further comprising a drive unit detachably connected to the coupler, the drive unit including a motor for driving the impeller.

13. A circuit board provided within the coupler and electrically connected to the first pressure sensor, A first coupling terminal provided on the coupler and electrically connected to the circuit board, The drive unit includes a second coupling terminal, The interventional medical device according to claim 12, characterized in that when the coupler and the driver are connected to each other, the first coupling terminal and the second coupling terminal are coupled to each other to form an electrical coupling channel.

14. A drive shaft is rotatably provided inside the catheter, with its distal end connected to the impeller in a manner that allows for transmission of energy. The drive member driven by the motor, The coupler further includes a driven member provided inside the coupler and scalably connected to the proximal end of the drive shaft, The interventional medical device according to claim 12, wherein one of the driving member and the driven member is a magnetic member, and the other is a magnetic member or a conductor, and the driven member and the driving member are coupled at a distance from each other with the coupler and the driving unit connected to each other, thereby enabling power transmission from the driving member to the driven member, the catheter extends into the coupler and is in fluid communication with the second chamber, the driven member is located inside the second chamber, and the proximal end of the driving shaft extends from the proximal end of the catheter and enters the inside of the second chamber and is ductilely connected to the driven member.

15. The aforementioned intervention sheath is Interventional sheath catheter and A sheath base formed at the proximal end of the intervention sheath catheter, wherein the catheter penetrates from the proximal end of the sheath base, passes through the intervention sheath catheter, and extends from the distal end of the sheath base, The intervention medical device according to claim 12, comprising a side branch tube provided on the sheath base and in fluid communication with the internal passage of the intervention sheath catheter, wherein one end of the side branch tube is connected to a port on the sheath base and communicates with the gap between the catheter and the intervention sheath catheter, and the other end communicates with the first chamber.

16. The interventional medical device according to claim 15, characterized in that the sheath base is provided with a suture buckle, and the device is secured by the suture buckle.

17. The interventional medical device according to claim 15, characterized in that the coupler is provided with the first chamber and a first joint and a second joint communicating with the first chamber, the first joint communicating with the first liquid storage bag of the first pipeline assembly and the second joint communicating with the side branch pipe.

Images