Interventional medical instrument

Abstract

The present application provides an interventional medical instrument, comprising an interventional sheath, a catheter, and a pressure measuring assembly, wherein the pressure measuring assembly can use a first irrigation liquid flowing through a gap between the interventional sheath and the catheter to measure blood pressure data in a human body, thereby allowing for monitoring of the physiological condition of a patient for interventional medical treatment. Also provided are an interventional catheter pump and a coupler thereof, applied to the interventional medical instrument to achieve a mechanical circulatory support effect on a cardiac pump function of a patient. The interventional catheter pump implements pressure measurement of the first irrigation liquid and a second irrigation liquid by means of a first chamber and a second chamber isolated from each other and formed in the coupler, and further implements electricity supply, signal transmission, and power supply between the coupler and a driver by means of coupling connection between the coupler and the driver, thereby greatly simplifying the structure of the coupler and reducing the production difficulty and production cost.

Description

Interventional medical devices

[0001] This application claims priority to the patent application submitted to the State Intellectual Property Office of China on July 27, 2023, with application number 202321991896.5 and application name "Interventional Medical Device". Technical Field

[0002] The present application relates to the technical field of medical devices, and in particular to an interventional medical device. Background Art

[0003] Interventional medical devices are devices that, under the supervision of imaging equipment such as digital subtraction angiography, CT, ultrasound, and MRI, use puncture needles, catheters, and other interventional equipment to introduce specific instruments into the patient's lesion through natural orifices or tiny incisions for diagnosis or minimally invasive treatment. During interventional medical procedures, close monitoring of the patient's physiological data, such as blood pressure and heart rate, is necessary. However, current interventional medical devices lack the necessary design.

[0004] Take, for example, an interventional catheter pump, an example of a mechanical circulatory support (MCS) system, which is increasingly being used to treat heart diseases such as heart failure. When treating acute myocardial infarction (MI) or compensated heart failure, an interventional catheter pump can stabilize patients after cardiogenic shock or provide support during high-risk percutaneous coronary intervention (PCI).

[0005] In the existing technology, interventional catheter pumps can be powered by an external motor, which transmits rotational power to the distal impeller through a drive shaft inserted into the catheter. The rotation of the impeller provides flow power to the blood. In order to understand the auxiliary flow rate that can be achieved when the mechanical circulatory support system is working in real time, the existing technology usually chooses to set a pressure sensor on the proximal side of the impeller and use an algorithm to estimate the flow rate generated by the rotation of the impeller. However, this structural design requires an additional lumen in the catheter for the sensor wire to pass through. This brings huge challenges to the process and drives up production costs.

[0006] In addition, the handle of the existing interventional catheter pump needs to take into account multiple functions such as power generation and transmission, flushing fluid and flushing fluid supply, power supply, signal transmission, etc., which makes its overall structure more complex and poses further challenges to the design and production of interventional catheter pumps.

[0007] Summary of the Invention

[0008] In order to solve the above problems, the present application proposes an interventional medical device that can utilize the structure of the interventional medical device outside the body to set up a corresponding pressure measurement component, instead of setting a sensor directly for detecting blood on the structure that intervenes in the body, thereby more conveniently measuring the blood pressure of the patient's arterial system and simplifying the structure of the interventional part of the device.

[0009] To achieve the above-mentioned objectives, the present application provides the following technical solutions: an interventional medical device, comprising: an interventional sheath, a proximal end of which is located outside the body of a subject, and a distal end of which is operable to enter the body of the subject; a catheter, a distal end of which is operable to enter the body of the subject through the interior of the interventional sheath, and a gap is provided between the catheter and the interventional sheath; a pressure measuring assembly, comprising: an operating part, connected to the proximal end of the catheter, and located outside the body of the subject, with a first chamber inside that is fluidically connected to the gap; a first pipeline assembly, fluidically connected to the first chamber, and configured to deliver a first flushing fluid to the first chamber; a first pressure sensor, disposed in the operating part and fluidically connected to the first chamber, for sensing the liquid pressure in the first chamber.

[0010] Furthermore, the first pipeline assembly includes: a first liquid storage bag for storing the first flushing liquid; a pressurizing device configured to pressurize the first flushing liquid; and a control valve configured to control the supply of the first flushing liquid in the first liquid storage bag to the first chamber.

[0011] Furthermore, the pressurizing device includes a fluid pump, and the fluid pump and the control valve are both arranged on a pipeline for connecting the first liquid storage bag and the first chamber.

[0012] Furthermore, the pressurizing device includes a pressurizing bag, which includes a sac for being mounted outside the first liquid storage bag and a pressurizing pump connected to the sac through a pipeline. The pressurizing pump is used to fill the sac with fluid so that the sac swells and squeezes the first liquid storage bag to achieve pressurization of the first flushing liquid.

[0013] Furthermore, the pressurized bag includes a pressure gauge, which is arranged on a pipeline connecting the bag and the pressurized pump.

[0014] Furthermore, the pressurized bag includes a pressure relief valve, which is arranged on the bag to release the pressurized fluid in the bag.

[0015] Furthermore, the first pipeline assembly includes a first state in which the control valve is in a closed state and a second state in which the control valve is in an open state; the liquid pressure in the first chamber in the first state is less than the liquid pressure in the second state, and the time the first pipeline assembly spends in the first state is greater than the time in the second state.

[0016] Furthermore, a second chamber is provided inside the operating part and is connected to the fluid inside the catheter, and the second chamber and the first chamber are sealed and isolated from each other; the interventional medical device also includes: a second pipeline assembly, which is fluidically connected to the second chamber and is configured to transport a second flushing fluid to the second chamber.

[0017] Furthermore, the interventional medical device further includes: a second pressure sensor, which is disposed in the operating portion and is in fluid communication with the second chamber, and is used to sense the liquid pressure in the second chamber.

[0018] Furthermore, the second pipeline assembly includes: a second liquid storage bag for storing the second flushing liquid; a first liquid supply pump, configured to pump out the second flushing liquid from the second liquid storage bag; a blending device, connected to the outlet of the first liquid supply pump, and fluidically connected to the second chamber through a downstream channel from the blending device to the second chamber and a reflux channel from the second chamber to the blending device; the second liquid supply pump, configured to pump out the second flushing liquid from the downstream channel of the blending device.

[0019] Furthermore, the interventional medical device further includes an action portion connected to the distal end of the catheter, and the action portion is configured to perform a preset medical action.

[0020] Furthermore, the interventional medical device includes an interventional catheter pump, which includes: a coupler, which is at least a part of the operating part; a pump head, which includes a pump casing connected to the distal end of the catheter and an impeller arranged inside the pump casing, and the impeller is driven to rotate so that blood is sucked in from the inlet of the pump casing and discharged from the outlet of the pump casing; a driver, which is detachably connected to the coupler and includes a motor for driving the impeller.

[0021] Furthermore, the interventional medical device includes: a circuit board, arranged in the coupler and electrically connected to the first pressure sensor; a first coupling terminal, arranged on the coupler and electrically connected to the circuit board; and a second coupling terminal, arranged on the driver; wherein, 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 and form an electrical connection channel.

[0022] Furthermore, the interventional medical device also includes: a drive shaft, rotatably disposed inside the catheter, and a distal end of which is drivably connected to the impeller; a driving member, driven by a motor; a follower, disposed inside the coupler, and drivably connected to the proximal end of the drive shaft; wherein, one of the driving member and the follower is a magnetic component, and the other is a magnetic component or a conductor; when the coupler and the driver are interconnected, the follower and the driving member are coupled to each other at intervals, thereby realizing power transmission from the driving member to the follower; the catheter extends into the interior of the coupler and is fluidically connected to the second chamber, the follower is located inside the second chamber, and the proximal end of the drive shaft extends from the proximal end of the catheter and enters into the interior of the second chamber and is drivably connected to the follower.

[0023] Furthermore, the interventional sheath includes: an interventional sheath catheter; a sheath seat, the sheath seat is formed at the proximal end of the interventional sheath catheter, the catheter enters from the proximal end of the sheath seat, passes through the interventional sheath catheter, and then exits from the distal end of the sheath seat; a side branch, the side branch is arranged on the sheath seat and is connected to the internal channel fluid of the interventional sheath catheter, one end of the side branch is connected to the interface of the sheath seat to communicate with the gap between the catheter and the interventional sheath catheter, and the other end of the side branch is connected to the first chamber.

[0024] Furthermore, a suture buckle is provided on the sheath tube seat to achieve fixation through the suture buckle.

[0025] Furthermore, the coupler is provided with a first chamber and a first joint and a second joint communicated with the first chamber, the first joint is communicated with the first liquid storage bag of the first pipeline assembly, and the second joint is communicated with the side branch pipe.

[0026] The interventional medical device provided herein utilizes the space between the catheter and the interventional sheath as a channel connecting the patient's blood circulation system and the first chamber. A chamber for a first flushing fluid to flow through is provided within the operating portion. A first pressure sensor for measuring the pressure of the first flushing fluid is integrated within the operating portion, thereby enabling in vivo blood testing with the sensor positioned externally. Furthermore, the catheter eliminates the need for a lumen for wiring, simplifying the catheter structure and reducing the need for wire installation, thereby lowering manufacturing difficulty and production costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings, which constitute part of this application, are intended to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are intended to explain the present invention and do not constitute an undue limitation of the present invention. In the accompanying drawings:

[0028] FIG1 is a schematic structural diagram of an interventional medical device according to an embodiment of the present application;

[0029] FIG2 is a schematic structural diagram of an interventional medical device according to another embodiment of the present application;

[0030] FIG3 is a schematic structural diagram of another embodiment of the pressurizing device of the first liquid storage bag in FIG1 or FIG2;

[0031] FIG4 is a schematic diagram of the appearance structure of the side branch tube connecting the coupler and the interventional sheath of the interventional catheter pump.

[0032] The above drawings include the following reference numerals: 1. interventional sheath; 11. interventional sheath catheter; 2. catheter; 202. drive shaft; 4. pressure measuring assembly; 41. operating unit; 411. first chamber; 42. first pipeline assembly; 421. first liquid storage bag; 422. pressurizing device; 423. control valve; 424. capsule; 425. pressurizing pump; 426. pressure gauge; 43. first pressure sensor; 44. second chamber; 45. second pipeline assembly; 451. second liquid storage bag; 452. first liquid supply pump; 453. blending device; 454. second liquid supply pump; 46. second pressure sensor; 51. coupler; 511. first connector; 512. second connector; 52. pump head; 521. pump housing; 522. impeller; 53. driver; 6. sheath holder; 62. suture buckle; 63. proximal end; 64. interface; 7. Side branch pipe. DETAILED DESCRIPTION

[0033] Various exemplary embodiments of the present application will now be described in detail with reference to the accompanying drawings. The description of the exemplary embodiments is merely illustrative and is in no way intended to limit the present application and its application or use. The present application can be implemented in many different forms and is not limited to the embodiments herein. These embodiments are provided to make the present application thorough and complete and to fully convey the scope of the present application to those skilled in the art. It should be noted that unless otherwise specifically stated, the relative arrangement of the parts and steps, the composition of the materials, the numerical expressions, and the numerical values ​​set forth in these embodiments should be interpreted as being merely exemplary, rather than as limiting.

[0034] The terms "proximal" and "distal" used in this embodiment are relative to the clinician operating the device. The term "proximal" refers to the portion relatively close to the clinician, while "distal" refers to the portion relatively far from the clinician. The proximal end of a component / assembly refers to the end relatively close to the clinician, while the distal end refers to the end relatively far from the clinician.

[0035] During interventional examinations or treatments, an interventional sheath is often used in conjunction with a catheter. The interventional sheath primarily serves to expand the percutaneous incision and facilitate catheter access to the patient's vasculature. During clinical use, a small incision is first made in the skin at the puncture site with a scalpel. The puncture site is then punctured with a puncture needle and a guidewire is inserted along the needle tube. The interventional sheath, which has been inserted with a dilator, is then inserted through the tail end of the guidewire and delivered to the blood vessel. Finally, the dilator is removed, thereby establishing a percutaneous access pathway for the intravascular device by delivering the front end of the interventional sheath to the first desired location in the patient's body.

[0036] Based on the percutaneous access pathway for the intravascular device established by the interventional sheath, the catheter is passed through the interior of the interventional sheath and extended into the human blood vessel, and reaches a second desired position in the patient's body under the guidance of the guidewire.

[0037] Depending on the purpose of interventional examination or treatment, the catheter has different functions accordingly.

[0038] For example, in interventional examinations, contrast agents can be delivered to specific locations in the body through a catheter for angiographic diagnosis, or a catheter can be used to puncture local lesions and extract tissue for pathological diagnosis.

[0039] For example, in interventional treatment, drugs or embolic agents can be injected into the diseased area in the body through a catheter for treatment, stents and other devices can be placed at designated locations in the body through a catheter, and a drive shaft can be set through a catheter to provide power for the human blood pump to assist the heart's pumping function.

[0040] The motion components described below typically differ for different purposes. The motion components can be adapted to suit different scenarios to achieve the corresponding purpose. For example, in interventional therapy, the motion component could be a pump head with a blood pumping function, or a stent that dilates blood vessels.

[0041] For the several types of interventional examinations or treatments introduced above, the interventional sheath and catheter are the structural basis for achieving specific medical purposes. Since the catheter needs to pass through the interior of the interventional sheath to enter the human body percutaneously, there is often a certain gap between the interventional sheath and the catheter. Since the distal ends of the interventional sheath and the catheter extend into the human body's blood circulation system, blood can easily enter the gap between the interventional sheath and the catheter, increasing the risk of thrombosis. The hazards of thrombosis are obvious, including but not limited to: thrombus flows with the blood flow throughout the body and then enters the brain, causing a stroke; thrombus does not flow and is retained somewhere in the blood vessel, causing poor oxygen supply to nearby nerve tissue and nerve damage, etc.

[0042] During invasive examinations or treatments, doctors also want to monitor the patient's vital signs in real time, particularly blood pressure, which indicates the health of the circulatory system. In particular, in mechanical circulatory support systems, such as invasive catheter pumps, it is desirable to understand the assistive flow rate achievable during operation of the impeller. One approach is to measure aortic blood pressure and calculate it through an algorithm, making accurate aortic blood pressure measurement crucial.

[0043] Based on the structural basis of the above-mentioned interventional sheath and catheter, and the need to accurately obtain aortic blood pressure, as shown in Figures 1 and 2, this embodiment provides an interventional medical device including a pressure measuring component, which performs a preset medical action by an action part connected to the distal end of the catheter 2, and uses the pressure measuring component 4 to utilize the gap between the interventional sheath 1 and the catheter 2 to perform in vitro measurement of the patient's blood pressure.

[0044] The pressure measurement component 4 includes an operating part 41 connected to the proximal end of the catheter 2. The operating part 41 is located outside the subject's body and is provided with a first chamber 411 inside that is fluidically connected to the gap between the interventional sheath 1 and the catheter 2. Based on the first chamber 411, the pressure measurement component 4 also includes a first pipeline component 42 that is fluidically connected to the first chamber 411, for delivering a first flushing liquid to the first chamber 411. Thus, the first flushing liquid enters the first chamber 411 from the first pipeline component 42, and is used to flush the gap between the catheter 2 and the interventional sheath 1, effectively avoiding the formation of thrombus. On this basis, the present application sets a first pressure sensor 43 in the operating part 41, which is used to sense the liquid pressure in the first chamber 411, thereby converting the blood pressure data in the human body based on the pressure of the first flushing liquid in the first chamber 411.

[0045] The principle of converting the pressure of the first flushing liquid to obtain blood pressure data in the human body is as follows: in a closed piping system, the pressure at each interconnected position of the piping system is equal. Specifically, for the interventional sheath 1 and catheter 2 inserted into the human body, their distal ends extend into the blood circulation system, and their proximal ends are fluidically connected to the first chamber 411 in the operating part 41. Therefore, the first chamber 411, the gap between the interventional sheath 1 and catheter 2, and the blood circulation system in the human body will together constitute a closed piping system that is interconnected. Therefore, by sensing the liquid pressure in the first chamber 411 through the first pressure sensor 43, the blood pressure data in the human body can be obtained accordingly.

[0046] Because the first pressure sensor 43 is located inside the operating portion 41 outside the body, the present invention avoids the need to install and deploy wires inside the catheter 2, as opposed to solutions that place the pressure sensor inside the body. Consequently, the structural complexity, process difficulty, and manufacturing cost of the pressure measurement system are significantly reduced.

[0047] In addition, clinical trials have proven that it is not necessary to deploy a wire for connecting the sensor inside the catheter 2, and the diameter of the catheter 2 can be significantly reduced, thereby reducing the interventional size of the device. Moreover, the reduction in the diameter of the catheter 2 means that the diameter of the matching interventional sheath 1 can also be reduced accordingly. In this way, during the working process after the action part completes the intervention, the patient's puncture port does not need to be maintained in a large expanded state. The small interventional size and the fact that the puncture port is not stretched open for a long time are very beneficial for reducing patient pain, avoiding complications, and quickly recovering patients after surgery.

[0048] First pressure sensor 43 is disposed within first chamber 411. This allows blood pressure measurement to be performed at the distal end of the circulatory system where the interventional sheath 1 and catheter 2 extend, utilizing the gap between the interventional sheath 1 and catheter 2. This allows the blood pressure measurement location to be closer to the target area for invasive examination or treatment. Consequently, compared to non-invasive in vitro blood pressure measurement, the blood pressure measurement results are closer to the actual blood pressure in the target area, providing more accurate and detailed blood pressure data for invasive examinations or treatments.

[0049] The first pipeline assembly 42 includes a first liquid reservoir bag 421, a pressurizing device 422, and a control valve 423. The first liquid reservoir bag 421 is used to store the first flushing fluid, and the control valve 423 is used to control the flow of the first flushing fluid into the first chamber 411 in real time, and can also be used to adjust the flow rate of the first flushing fluid from the first liquid reservoir bag 421 into the first chamber 411. The pressurizing device 422 acts on the first liquid reservoir bag 421 to pressurize the first flushing fluid in the first liquid reservoir bag 421 to a set pressure value to meet the pressure requirements of the first flushing fluid in the human circulatory system and the gap between the interventional sheath 1 and the catheter 2.

[0050] The pressurizing device 422 can be any structure capable of pressurizing the first flushing fluid. For example, in one alternative embodiment, the pressurizing device 422 can be a fluid pump, such as a peristaltic pump, as shown in Figures 1 or 2, located in the pipeline connecting the first fluid storage bag 421 and the first chamber 411. Alternatively, in another alternative embodiment, the pressurizing device 422 is a pressurized bag, as shown in Figure 3, comprising a bladder 424 positioned outside the first fluid storage bag 421 and a pressurizing pump 425 connected to the bladder via a pipeline. The pressurizing pump 425 can be a manual or electric pressurizing pump, configured to fill the bladder 424 with fluid, causing the bladder 424 to expand and squeeze the first fluid storage bag 421, thereby pressurizing the first flushing fluid. A pressure gauge 426 can be provided on the pipeline connecting the bladder and the pressurizing pump to facilitate real-time monitoring of the pressurized fluid. The bladder 424 is equipped with a pressure relief valve for venting the pressurized fluid, such as gas, within the bladder, thereby relieving the pressure of the pressurized bag. The control valve 423 is provided on the pipeline connecting the first liquid storage bag 421 and the first chamber 411 , and can be any suitable existing structure, such as a solenoid valve, a pipe clamp, etc.

[0051] The first pipeline assembly 42 of this embodiment not only needs to perform the pumping function of the first flushing liquid but also assists the first pressure sensor 43 in performing its pressure sensing function. It should be understood that if the pressure is measured during the pumping of the first flushing liquid, the pressure measurement value will be closer to the output pressure of the pressurizing device 422 of the first pipeline assembly 42 than to the human blood pressure. Therefore, the present application defines the state in which the first pipeline assembly 42 delivers the first flushing liquid to the first chamber 411 as including at least a first state and a second state.

[0052] Specifically, the pressure of the first flushing fluid in the first state is lower than the pressure in the second state. Furthermore, the flushing fluid pressure in the first state is roughly equal to human blood pressure when stable, while the flushing fluid pressure in the second state is greater than human blood pressure. This allows the first flushing fluid to pass through the gap between the interventional sheath 1 and catheter 2 at a higher pressure and enter the human blood system, thereby fully flushing the gap between the interventional sheath 1 and catheter 2 and removing any blood that has infiltrated the gap, reducing or preventing the formation of blood clots.

[0053] Based on the above technical content, it can be understood that the first state is the state when the control valve 423 is closed, and the second state is the state when the control valve 423 is open. When the control valve 423 is opened, since the flushing liquid pressure is greater than the human blood pressure at this time, the first flushing liquid flows out rapidly from the gap between the interventional sheath 1 and the catheter 2, thereby flushing out the blood retained in the gap, and preventing the blood in the gap from being retained for a long time to form a thrombus. After flushing for a predetermined period of time, the control valve 423 is closed. At the moment the control valve 423 is closed, the flushing liquid pressure in the gap is still greater than the blood pressure, and then the flushing liquid in the gap continues to flow out from the distal end. As the flushing liquid flows out, the pressure of the flushing liquid in the gap gradually decreases until it stops flowing out when it is roughly equal to the blood pressure, reaching a state of stable pressure. Since the first chamber 411 is connected to the human blood circulation system fluid through the gap, the pressure in the first chamber 411 measured by the first pressure sensor 43 is roughly the human blood pressure.

[0054] The pressurizing device 422 and the control valve 423 further control the time that the first flushing liquid is in the first state to be greater than the time in the second state. It should be understood that during the process of interventional examination or treatment, although the first flushing liquid can be selected as heparinized saline or other similar liquids to reduce the impact of the first flushing liquid entering the human body on the blood circulation system. However, it should still be avoided as much as possible that the first flushing liquid enters the human body too much to avoid destroying the original balance of the human blood circulation system. Therefore, the flushing method for the gap between the interventional sheath 1 and the catheter 2 can be intermittent rather than continuous. For example, in one embodiment, after opening the control valve 423 and continuing to flush for a predetermined time of 2-3 seconds (or even shorter), the control valve 423 is quickly closed.

[0055] In the above embodiment, the first state can be considered the normal state of the first pipeline assembly 42, while the second state can be considered the flushing state of the first pipeline assembly 42. However, it should be noted that with the development of technology and the needs of actual examinations or treatments, the above-mentioned first state can be further divided into multiple more specific states for invasive medical devices. Therefore, the relationship between time and pressure defined in this application is no longer limited to the first and second states in the above embodiment.

[0056] It should be understood that this embodiment specifies that the liquid pressure in the second state is greater than the liquid pressure in the first state in order to ensure that the first flushing liquid has sufficient kinetic energy to flush the gap between the interventional sheath 1 and the catheter 2, and that the duration of the flushing liquid in the second state is less than that in the first state in order to reduce the possibility of excessive first flushing liquid entering the blood circulation system and affecting the body's internal balance. Based on this concept, those skilled in the art may adjust the liquid pressure and duration in the first and second states according to actual needs, and this embodiment does not impose any additional limitations on this.

[0057] As shown in FIG2 , in another embodiment, the operating portion 41 further includes a second chamber 44, which is sealed and isolated from the first chamber 411 and does not communicate with each other. A second piping assembly 45 is fluidically connected to the second chamber 44 and is configured to deliver a second flushing fluid to the second chamber 44. The pressure measurement system also includes a second pressure sensor 46, which is also located within the operating portion 41 and is used to sense the pressure in the second chamber 44. This helps people obtain the real-time perfusion pressure of the second flushing fluid, providing assistance for invasive examinations or treatments.

[0058] The second chamber 44 and the second pipe assembly 45 that cooperates therewith are used to pump the second flushing liquid into the catheter 2. The second flushing liquid flows along the catheter 2 toward the distal end, thereby lubricating and cooling the rotating parts in the catheter 2 and the operating part. In particular, when the solution of this embodiment is applied to the scenario of an interventional catheter pump, the rotating part in the catheter 2 is the flexible drive shaft 202, and the rotating parts of the operating part are the proximal bearing and distal bearing that support the rotation of the impeller 522. Regarding the solution of the second chamber 44 cooperating with the second pipe assembly 45 to achieve the above-mentioned lubrication and cooling, please refer to the description of Chinese Patent ZL202211578294.7, which will not be repeated here.

[0059] The first pressure sensor 43 and the second pressure sensor 46 are both arranged in the operating part 41. By utilizing the first chamber 411 and the second chamber 44 in the operating part 41, which are separated from each other and have no fluid communication with each other, the first pressure sensor 43 can sense the human blood pressure based on the first chamber 411, and the second pressure sensor 46 can sense the pressure of the second flushing fluid based on the second chamber 44. As a result, the pressure measurement system of the present application can accurately sense the pressure of the extracorporeal fluid and the internal blood involved in the interventional examination or treatment, and improve the timeliness and accuracy of the acquisition of pressure data during the interventional examination or treatment. In addition, the first pressure sensor 43 and the second pressure sensor 46 are both arranged in the operating part 41, which further improves the integration of the pressure measurement system and has a more reasonable structural design.

[0060] The second pipeline assembly 45 includes a second liquid storage bag 451, a first liquid supply pump 452, a blending device 453, and a second liquid supply pump 454. The second liquid storage bag 451 stores a second flushing liquid. The first liquid supply pump 452, which may be a peristaltic pump, is disposed on the pipeline connecting the second liquid storage bag 451 and the blending device 453 and is configured to continuously pump the second flushing liquid from the second liquid storage bag 451. The blending device 453 is connected to the outlet of the first liquid supply pump 452 and is provided with a downstream channel from the blending device 453 to the second chamber 44 and a reflux channel from the second chamber 44 to the blending device 453. The second liquid supply pump 454, which may also be a peristaltic pump, is configured to pump the second flushing liquid from the downstream channel of the blending device 453.

[0061] Under the action of the first liquid supply pump 452 and the second liquid supply pump 454, the second flushing liquid is pumped out of the second liquid storage bag 451 and supplied to the second chamber 44 via the downstream channel of the blending device 453. To ensure that the second flushing liquid in the second chamber 44 meets the required flow rate for perfusion into the human body, a reflux channel is provided between the blending device 453 and the second chamber 44. This allows a portion of the second flushing liquid pumped into the second chamber 44 to enter the human body through the catheter 2, while the remainder returns to the blending device 453 through the reflux channel. Since the flow rate of the second flushing liquid through the catheter 2 is determined by the flow area of ​​the catheter 2, the provision of the reflux channel ensures that the amount of liquid entering the human body through the second chamber 44 is not excessive.

[0062] As shown in Figures 1, 2, and 4, in a specific embodiment, the interventional medical device is an interventional catheter pump, which includes a coupler 51, a pump head 52, and a driver 53. The pump head 52 includes a pump housing 521 connected to the distal end of the catheter 2 and an impeller 522 disposed within the pump housing 521. The impeller 522 is driven to rotate, causing blood to be drawn in from the inlet of the pump housing 521 and discharged from the outlet of the pump housing 521. The coupler 51 and the driver 53 are detachably coupled to each other, and through this coupling relationship, power is transmitted from the driver 53 to the coupler 51, further driving the impeller 522 to rotate.

[0063] Similarly, regarding the relevant structure of the interventional catheter pump and the non-contact coupling method between the coupler 51 and the driver 53, reference can also be made to the description of Chinese patent ZL202211578294.7, which will not be repeated here.

[0064] Thus, the coupler 51 of the interventional catheter pump can serve as at least a part of the operating portion 41 of the interventional medical device, and the pump head 52 can serve as at least a part of the working portion of the interventional medical device, thereby utilizing the blood pressure flow driven by the rotation of the impeller 522 to support the pump function of the patient's heart. It should be understood that the interventional medical device can perform a variety of different treatment or examination actions according to the needs of the patient, such as "simultaneously" achieving drug injection and stent placement for the patient, or "simultaneously" achieving angiographic diagnosis and mechanical circulatory assistance for the patient. At this time, the operating portion 41 and the working portion of the interventional medical device can respectively include operating components and working components corresponding to different uses, and different medical operations can be completed with the help of the interventional medical device constructed with the same set of interventional sheath 1, catheter 2 and pressure measurement component 4, thereby saving the material cost of interventional medical treatment, saving medical time and alleviating the patient's pain.

[0065] It should be noted that the term "simultaneously" does not limit different types of interventional medical procedures to being performed at the same time. It refers to interventional medical devices constructed using the same set of interventional sheaths 1, catheters 2, and pressure measurement components 4. Of course, different types of interventional medical procedures can also be performed on patients at the same time. In this case, the pressure measurement component 4 provided in this application can still accurately and timely obtain blood pressure data from the patient, assisting doctors in monitoring the patient's physiological condition and formulating medical strategies.

[0066] A circuit board is housed within the coupler 51. A first coupling terminal is located at the proximal end of the coupler 51, and a second coupling terminal is located at the distal end of the driver 53. When the coupler 51 and driver 53 are connected, the first and second coupling terminals connect to form an electrical connection path. The circuit board is electrically connected to the first and second pressure sensors 43, 46, and to the first coupling terminals. Thus, an electrical connection path is formed within the coupler 51, from the first and second pressure sensors 43, 46 to the circuit board and then to the first coupling terminals. An electrical connection path is also formed outside the coupler 51, from the first and second coupling terminals to the second coupling terminals.

[0067] When the coupler 51 and the driver 53 are connected to each other, an electrical connection path is formed by connecting the first coupling terminal and the second coupling terminal. Thus, this embodiment connects the electrical connection path within the coupler 51 to the driver 53, thereby utilizing the driver 53 to provide electrical energy to the coupler 51, thereby preventing leakage of the first or second flushing liquid within the coupler 51 from adversely affecting the electrical connection path.

[0068] The electrical connection pathways between the circuit board and the first pressure sensor 43, the second pressure sensor 46, and the first coupling terminal, as well as the electrical connection pathways formed between the first coupling terminal and the second coupling terminal, not only transmit electrical energy to power the electronic components but also transmit corresponding sensing signals or control signals. That is, through these electrical connection pathways, the first pressure sensor 43 and the second pressure sensor 46 can transmit the pressure signals sensed in the first chamber 411 and the second chamber 44 to the circuit board, and then to the driver 53 via the first coupling terminal and the second coupling terminal. Wired communication established through these electrical connection pathways can effectively improve communication reliability and real-time performance, which is critical for ensuring the safe operation of invasive medical devices and the health of patients.

[0069] As shown in FIG4 , the coupler 51 is provided with a first connector 511 and a second connector 512 for communicating with the first chamber 411. The first connector 511 is connected to the first liquid storage bag 421 via a pipeline, and the second connector 512 is connected to the gap between the interventional sheath 1 and the catheter 2 via the side branch 7. Based on the circumferential positional relationship of the interventional sheath 1 relative to the catheter 2, the first pipeline assembly 42 provides the liquid in the first liquid storage bag 421 to the first chamber 411 via the liquid inlet direction shown in the figure. Subsequently, the first flushing liquid in the first chamber 411 enters the side branch 7 of the interventional sheath 1 via the liquid outflow direction shown in the figure, and finally flows through the gap between the interventional sheath 1 and the catheter 2 to the first desired position, while the second flushing liquid in the second chamber 44 flows through the catheter 2 to the second desired position.

[0070] The first desired position varies depending on the specific application scenario of the catheter pump. For example, in a scenario where the catheter pump is used to assist the left heart, the first desired position is somewhere within the left ventricle, and the second desired position is somewhere within the aorta. In a scenario where the catheter pump is used to assist the right heart, the first desired position is approximately somewhere in the pulmonary veins, and the second desired position is somewhere within the right ventricle.

[0071] As shown in Figures 1 and 2, a drive shaft 202 is provided inside the catheter 2. The drive shaft 202 is preferably a flexible drive shaft that can bend with the catheter 2 within the human vascular system, thereby extending to a desired location within the human body. The distal end of the catheter 2 is connected to a pump housing 521, and an impeller 522 is provided inside the pump housing 521. When the pump housing 521 reaches a desired location within the human body, such as the left ventricle, the impeller 522 provided therein is driven by the rotational power provided by the drive shaft 202, drawing blood from the inlet of the pump housing 521 located in the left ventricle and discharging it from the outlet of the pump housing 521 located in the aorta, thereby assisting the heart's pumping function.

[0072] The above is a foldable catheter pump, and the pump housing 521 and the impeller 522 are both foldable. It is worth noting that the application scenario of the solution of this embodiment is not limited to this. In fact, a non-foldable catheter pump is also applicable to the solution of this application. Similarly, the above-mentioned catheter pump is an external power device. Based on the above, the catheter pump can also adopt a power device built-in structure. At this time, the power device, such as a motor, is connected to the distal end of the catheter 2, and the slender flexible drive shaft 202 is no longer passed through the catheter 2. The power device drives the impeller 522 by means of a hard short shaft, magnetic coupling, etc.

[0073] In an interventional catheter pump, the first flushing liquid enters the first desired position in the human body from the gap between the catheter 2 and the interventional sheath 1, thereby flushing the gap between the catheter 2 and the interventional sheath 1 and preventing the formation of thrombus. In addition, since the flushing of the gap between the catheter 2 and the interventional sheath 1 by the first flushing liquid is intermittent, during the flushing process of the first flushing liquid, the first pressure sensor 43 can sense the pressure of the first flushing liquid. In addition to the flushing of the first flushing liquid, the first pressure sensor 43 can sense the blood pressure in the human body through the balance established between the first flushing liquid in the gap between the catheter 2 and the interventional sheath 1 and the blood pressure in the human body. In the scenario where the catheter pump is used for left ventricular assist, the above-mentioned 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-mentioned blood pressure is basically reflected as the pumping pressure given to the blood by the pump head 52.

[0074] The second flushing fluid flows from the catheter 2 to a second desired location in the human body, thereby lubricating and cooling the catheter 2 and the drive shaft rotating therein as well as the proximal and distal bearings. For this, the second pressure sensor 46 can sense the pressure of the second flushing fluid in real time.

[0075] The interventional catheter pump also includes a driver and a follower. The driver is driven by a motor, while the follower is located within coupler 51 and drivably connected to the proximal end of the drive shaft. When coupler 51 is connected to the power unit, the follower and driver are spaced apart and coupled to each other, thereby transmitting power from the driver to the follower. The transmission connection between the follower and drive shaft 202 then transmits the motor's power through the driver, follower, and drive shaft 202 to impeller 522, which then rotates to pump blood.

[0076] The non-contact transmission between the driver and the follower can effectively prevent the second flushing liquid from invading the interior of the driver 53 and affecting electrical components such as the motor. Specifically, the catheter 2 extends into the interior of the coupler 51 and is in fluid communication with the second chamber 44. The follower is located inside the second chamber 44. The proximal end of the drive shaft extends from the proximal end of the catheter 2 and enters the interior of the second chamber 44 and is drivably connected to the follower. As a result, the follower is drivably connected to the drive shaft inside the second chamber 44, thereby further confining the second flushing liquid to the second chamber 44 of the coupler 51 and the interior of the catheter 2, preventing the second flushing liquid from flowing into other locations of the coupler 51 and causing adverse effects.

[0077] The interventional sheath 1 can adopt any suitable existing structure, for example, the known embodiment provided by publication number CN115227962A. As shown in Figure 4, the interventional sheath 1 generally includes an elongated interventional sheath catheter 11, a sheath tube seat 6 formed at the proximal end of the interventional sheath catheter 11, and a side branch 7 provided on the sheath tube seat 6 and connected to the internal channel fluid of the interventional sheath catheter 11. The catheter 2 penetrates from the proximal end 63 of the sheath tube seat 6, and further passes through the interventional sheath catheter 11 and exits from its distal end. One end of the side branch 7 is connected to the sheath tube seat 6 through the interface 64, and is further connected to the above-mentioned gap formed between the two after the catheter 2 is penetrated into the interventional sheath, and the other end is connected to the first chamber 411. During the entire working process of the pump head 52, the interventional sheath 1 is fixed to the patient's skin by the suture buckle 62 provided on the sheath tube seat 6 to achieve fixation.

[0078] It should be noted that, in order to achieve sealing and prevent liquid leakage and blood leakage, a sealing structure is provided in the sheath tube seat 6. For details, please refer to the above-mentioned known embodiments and will not be described in detail.

[0079] Coupler 51 is connected to catheter 2, acting as an intermediate structure to provide a secondary flushing fluid to catheter 2 and a primary flushing fluid to the gap between catheter 2 and interventional sheath 1. Coupler 51 also provides the primary flushing fluid and blood pressure measurement data through the gap between catheter 2 and interventional sheath 1. Coupler 51 is also mated and connected to driver 53, achieving a coupled connection between electrical energy, communication signals, and rotational drive.

[0080] The coupler 51 includes a housing, a first chamber 411 within the housing, and a second chamber 44. The first chamber 411 is configured to receive a first flushing fluid and deliver it to the gap between the catheter 2 and the interventional sheath 1. The second chamber 44, separate from the first chamber 411, receives a second flushing fluid and delivers it to the interior of the catheter 2.

[0081] Based on the structure of the first chamber 411 and the second chamber 44 isolated from each other in the coupler 51 , a first pressure sensor 43 and a second pressure sensor 46 are respectively provided inside the shell to measure the pressures of the first chamber 411 and the second chamber 44 .

[0082] As previously mentioned, since the first flushing fluid in the first chamber 411 has at least two states, the first pressure sensor 43 measures the first flushing fluid pressure when the first flushing fluid is flushing, and measures the blood pressure when the first flushing fluid is not flushing. The second pressure sensor 46 measures the pressure of the second flushing fluid in the second chamber 44 to determine the perfusion pressure of the second flushing fluid into the body.

[0083] The coupling method between the driver and the driven member may be magnetic coupling, in which case both are magnetic components. Alternatively, the coupling method between the driver and the driven member may be eddy current coupling, in which case both are magnetic components and conductors, respectively.

[0084] Based on the coupling connection between the first coupling terminal and the second coupling terminal, and the coupling connection between the follower and the driving member, the power supply, signal transmission and power supply inside the coupler 51 can be provided by the power device outside the coupler 51 in a non-contact manner, thereby forming a relatively independent sealed space inside the coupler 51, avoiding adverse effects on the power supply, signal transmission and power supply due to leakage of the first flushing liquid and the second flushing liquid.

[0085] The catheter 2 extends into the interior of the coupler 51 and is in fluid communication with the second chamber 44. The follower is located within the second chamber 44. The proximal end of the drive shaft extends from the catheter 2 into the interior of the second chamber 44 and is drivably connected to the follower. Thus, the follower is drivably connected to the connecting shaft within the second chamber 44, thereby further confining the second flushing fluid to the second chamber 44 of the coupler 51 and the interior of the catheter 2, preventing the second flushing fluid from flowing into other locations within the coupler 51 and causing adverse effects.

[0086] In summary, the interventional medical device provided in the present application can utilize the two states of the gap between the catheter 2 and the interventional sheath 1 and the first flushing fluid in the gap. In the flushing state of the first flushing fluid, the gap between the catheter 2 and the interventional sheath 1 is flushed to avoid the formation of thrombus. In the non-flushing state of the first flushing fluid, the gap between the catheter 2 and the interventional sheath 1 is used as a pipeline connected to the human blood circulation system and the first chamber 411 to accurately measure the human blood pressure.

[0087] In addition, the present application provides a chamber for the first flushing fluid to flow through in the coupler 51 of the interventional catheter pump, so that the first pressure sensor 43 for measuring the pressure of the first flushing fluid is integrated into the coupler 51, thereby simplifying the structure of the catheter 2 and the installation of the wires by arranging the sensor outside the body, reducing the manufacturing difficulty and production cost.

[0088] Although the embodiments disclosed in this application are as described above, the contents described are merely embodiments adopted to facilitate understanding of this application and are not intended to limit this application. Any person skilled in the art to which this application belongs may make any modifications and changes in the form and details of the implementation without departing from the spirit and scope disclosed in this application.

Claims

1. An interventional medical device, characterized in that: include: an introduction sheath, the proximal end of which is located outside the subject's body and the distal end of which is operable to enter the subject's body; A catheter, the distal end of which is operable to enter the subject through the interior of the intervention sheath, and a gap is formed between the catheter and the intervention sheath; Pressure measurement kit, including: an operating part, connected to the proximal end of the catheter and located outside the subject's body, and having a first chamber in the operating part that is in fluid communication with the gap; a first piping assembly, fluidically connected to the first chamber and configured to deliver a first flushing fluid to the first chamber; The first pressure sensor is disposed in the operating portion and is in fluid communication with the first chamber, and is used for sensing the liquid pressure in the first chamber.

2. The interventional medical device according to claim 1, characterized in that: The first pipeline assembly comprises: A first liquid storage bag, used for storing the first flushing liquid; a pressurizing device, configured to pressurize the first flushing liquid; The control valve is configured to control the supply of the first flushing liquid 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 the fluid pump and the control valve are both arranged on a pipeline for connecting the first liquid storage bag and the first chamber.

4. The interventional medical device according to claim 2, characterized in that: The pressurizing device includes a pressurizing bag, which includes a bladder for being mounted outside the first liquid storage bag and a pressurizing pump connected to the bladder through a pipeline. The pressurizing pump is used to fill the bladder with fluid so that the bladder expands and squeezes the first liquid storage bag to achieve pressurization of the first flushing liquid.

5. The interventional medical device according to claim 4, characterized in that: The pressurizing bag includes a pressure gauge, which is arranged on a pipeline for connecting the bladder and the pressurizing pump.

6. The interventional medical device according to claim 4, characterized in that: The pressurized bag includes a pressure relief valve, which is arranged on the bladder to release the pressurized fluid in the bladder.

7. The interventional medical device according to claim 2, characterized in that: The first pipeline assembly includes a first state in which the control valve is in a closed state and a second state in which the control valve is in an open state; the liquid pressure in the first chamber in the first state is lower than the liquid pressure in the second state, and the time of the first pipeline assembly in the first state is longer than the time in the second state.

8. The interventional medical device according to claim 1, characterized in that: The operating part is also provided with a second chamber connected to the internal fluid of the catheter, and the second chamber and the first chamber are sealed and isolated from each other; the interventional medical device also includes: a second pipeline assembly, which is fluidically connected to the second chamber and is configured to transport a second flushing fluid to the second chamber.

9. The interventional medical device according to claim 8, characterized in that: The invasive medical device further includes: a second pressure sensor, which is disposed in the operating portion and is in fluid communication with the second chamber, and is used to sense the liquid pressure in the second chamber.

10. The interventional medical device according to claim 8, characterized in that: The second pipeline assembly comprises: A second liquid storage bag, used for storing the second flushing liquid; a first liquid supply pump, configured to pump out the second flushing liquid from the second liquid storage bag; a blending device connected to the outlet of the first liquid supply pump and in fluid communication with the second chamber via a downstream channel from the blending device to the second chamber and a reflux channel from the second chamber to the blending device; The second liquid supply pump is configured to pump out the second flushing liquid from the downstream channel of the blending device.

11. The interventional medical device according to claim 10, characterized in that: The invasive medical device further includes an action portion connected to the distal end of the catheter, and the action portion is configured to perform a preset medical action.

12. The interventional medical device according to claim 10, characterized in that: The interventional medical device comprises an interventional catheter pump, and the interventional medical device comprises: A coupler, which is at least a part of the operating portion; A pump head, comprising a pump housing connected to the distal end of the catheter and an impeller disposed inside the pump housing, wherein the impeller is driven to rotate so that blood is sucked from the inlet of the pump housing and discharged from the outlet of the pump housing; A driver, detachably connected to the coupler, includes a motor for driving the impeller.

13. The interventional medical device according to claim 12, characterized in that: The interventional medical device comprises: a circuit board, disposed in 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; A second coupling terminal, provided on the driver; Wherein, 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 and form an electrical connection channel.

14. The interventional medical device according to claim 12, characterized in that: The interventional medical device further comprises: A drive shaft, rotatably disposed inside the conduit, with a distal end thereof being driveably connected to the impeller; a driving member, driven by the motor; A driven member, disposed inside the coupler and drivably connected to the proximal end of the drive shaft; Among them, one of the driving member and the driven member is a magnetic component, and the other is a magnetic component or a conductor; when the coupler and the driver are connected to each other, the driven member and the driving member are coupled to each other at a distance, thereby realizing power transmission from the driving member to the driven member; the catheter extends into the interior of the coupler and is fluidly connected to the 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 into the interior of the second chamber and is drivably connected to the driven member.

15. The interventional medical device according to claim 12, characterized in that: The interventional sheath comprises: Interventional sheath catheter; A sheath tube seat, wherein the sheath tube seat is formed at the proximal end of the interventional sheath catheter, and the catheter is inserted from the proximal end of the sheath tube seat, passes through the interventional sheath catheter, and then exits from the distal end of the sheath tube seat; A side branch tube is arranged on the sheath tube seat and is connected to the internal channel fluid of the interventional sheath catheter, one end of the side branch tube is connected to the interface of the sheath tube seat to communicate with the gap between the catheter and the interventional sheath catheter, and the other end of the side branch tube is connected to the first chamber.

16. The interventional medical device according to claim 15, characterized in that: The sheath tube seat is provided with a suture buckle to achieve fixation through 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 communicated with the first chamber, the first joint is communicated with the first liquid storage bag of the first pipeline assembly, and the second joint is communicated with the side branch pipe.

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