Feedback-regulated hemostatic valve, catheter sheath, and sealing method for interventional devices

Abstract

The present application discloses a feedback-regulated hemostatic valve, a catheter sheath, and a sealing method for an interventional device. The feedback-regulated hemostatic valve includes a housing and a sealing membrane installed in the housing and having a tubular structure. The inner cavity of the tubular structure serves as an instrument channel. A driving chamber for filling a fluid is provided in the housing and is located outside the sealing membrane. The feedback-regulated hemostatic valve further includes a pressurizing mechanism for feeding back blood pressure changes to the fluid. The technical solution disclosed in the present application, through the arrangement of the pressurizing mechanism, feeds back blood pressure changes to the fluid, thereby adaptively adjusting the sealing pressure of the sealing membrane, improving the effect of the sealing membrane closing the instrument channel during the movement of the interventional device relative to the sealing membrane, improving the operation experience of operators such as medical staff, providing a stable treatment process, and improving the treatment effect.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to a feedback-regulated hemostatic valve, a catheter sheath, and a sealing method for interventional devices. Background Art

[0002] Interventional therapy is a cutting-edge treatment technology developed in recent years that lies between medication and surgical operations. Interventional therapy techniques typically require the use of medical imaging devices such as X-ray fluoroscopy, CT positioning, and B-ultrasound machines as guidance to deliver a catheter device loaded with interventional devices (such as vascular stents, artificial heart valves) or drugs through the arteries and veins of the human body to reach the diseased area in the body, thereby achieving the purpose of diagnosing and treating diseases.

[0003] The catheter sheath provides a passage for the catheter device to enter the human body and also creates an outflow outlet for blood or other body fluids. To prevent blood loss, a sealing hemostatic valve is usually provided inside the catheter sheath. The problem in existing technical solutions is the contradiction between the sealing function of the hemostatic valve and the penetrability function that facilitates the passage of interventional devices. To prevent blood from flowing out, it is often necessary to improve the sealing performance, but this will correspondingly affect the penetrability of the interventional device within the hemostatic valve.

[0004] Technical improvements to the hemostatic valve have also been disclosed in related technologies. For example, in a certain related technology, the hemostatic valve includes a housing and a tubular sealing film located inside the housing. An annular sealed cavity is formed between the outer periphery of the tubular sealing film and the housing, and the size of the sealed cavity is adjusted by injecting a filling material into the sealed cavity, thereby achieving the opening and closing of the hemostatic valve. The inventor found that after the sealing film is sealed, a large friction will be generated between the sealing film and the interventional device. To facilitate the operation of the interventional device relative to the position of the hemostatic valve, it is necessary to frequently adjust the pressure of the sealed cavity to adjust the sealing state of the sealing film. The operation is relatively cumbersome, and it is difficult to control the accuracy, which affects the treatment process. Summary of the Invention

[0005] To solve the above technical problems, this application discloses a feedback-regulated hemostatic valve, which includes a housing and a sealing film installed inside the housing and having a tubular structure. The inner cavity of the tubular structure serves as an instrument channel. A driving chamber for filling fluid is provided inside the housing and is located outside the sealing film. The feedback-regulated hemostatic valve further includes a pressurizing mechanism for feeding back blood pressure changes to the fluid.

[0006] The following also provides several optional ways, which are not additional limitations to the above overall solution, but are only further supplements or optimizations. Without technical or logical contradictions, each optional way can be combined with the above overall solution alone, or multiple optional ways can be combined with each other.

[0007] Optionally, the pressurizing mechanism has an input port for collecting blood pressure and an output port after pressurization, and the output of the pressurizing mechanism acts directly or indirectly on the fluid in the driving chamber.

[0008] Optionally, the pressurizing mechanism includes a support body, and two cylinders with different bore diameters are arranged inside the support body. A sliding member is hermetically and slidably installed in each cylinder, and the sliding members in the two cylinders are interlocked with each other;

[0009] The input port communicates with the first cylinder with a larger bore diameter; the output port communicates with the second cylinder with a smaller bore diameter.

[0010] Optionally, the two cylinders communicate with each other, and the communicating part is a linkage chamber located between the two sliding members. The two sliding members are interlocked with each other through the medium pressure in the common linkage chamber.

[0011] Optionally, the sliding member in the first cylinder is the first sliding member. One side of the first sliding member is an input chamber communicating with the input port, and the other side is the common linkage chamber;

[0012] The sliding member in the second cylinder is the second sliding member. One side of the second sliding member is an output chamber communicating with the output port, and the other side is the common linkage chamber.

[0013] Optionally, the two cylinders are isolated from each other, and the two sliding members are directly connected by a connecting member. Both ends of the connecting member are hermetically inserted into the respective cylinders and connected to the corresponding sliding members.

[0014] Optionally, the sliding member in the first cylinder is the first sliding member. One side of the first sliding member is an input chamber communicating with the input port, and the other side is the first linkage chamber;

[0015] The sliding member in the second cylinder is the second sliding member. One side of the second sliding member is an output chamber communicating with the output port, and the other side is the second linkage chamber;

[0016] Both ends of the connecting member are hermetically inserted into the respective linkage chambers and connected to the corresponding sliding members.

[0017] Optionally, the feedback-regulated hemostatic valve is provided with a blood pressure feedback hole that can communicate with a blood vessel in the use state, and the blood pressure feedback hole is communicated with the input port through a feedback pipeline.

[0018] Optionally, one end of the instrument channel is an instrument inlet and the other end is an instrument outlet, and the blood pressure feedback hole is adjacent to the side of the instrument outlet.

[0019] Optionally, the feedback-regulated hemostatic valve is provided with an exhaust hole, and the exhaust hole and the blood pressure feedback hole are respectively arranged.

[0020] Optionally, the feedback-regulated hemostatic valve is provided with an exhaust hole, which also serves as the blood pressure feedback hole. An exhaust bypass is connected to the feedback pipeline, and an exhaust valve is provided on the exhaust bypass.

[0021] Optionally, the support body and the housing are of an integral or split structure.

[0022] Optionally, the two cylinder chambers are arranged coaxially, side by side, or nested inside and outside.

[0023] Optionally, the axes of the two cylinder chambers are parallel, skew, or perpendicular.

[0024] Optionally, the output port of the pressurizing mechanism is communicated with the driving chamber.

[0025] Optionally, the pressurizing mechanism includes a support body. Inside the support body, there are two cylinder chambers with different cylinder diameters. A sliding member is hermetically and slidably installed in each cylinder chamber, and the sliding members in the two cylinder chambers are interconnected;

[0026] The input port is communicated with the first cylinder chamber with a larger cylinder diameter; the output port is communicated with the second cylinder chamber with a smaller cylinder diameter;

[0027] The two cylinder chambers are communicated with each other. At the communicating part, there is a linkage chamber located between the two sliding members. The two sliding members are interconnected through the medium pressure in the linkage chamber.

[0028] Optionally, a fourth pressure regulating hole communicated with the linkage chamber is provided on the chamber wall of the linkage chamber; on the chamber wall of the cylinder chamber with a smaller cylinder diameter, a fifth pressure regulating hole communicated with the output port is provided.

[0029] Optionally, the pressurizing mechanism includes a support body. Inside the support body, there are two cylinder chambers with different cylinder diameters. A sliding member is hermetically and slidably installed in each cylinder chamber, and the sliding members in the two cylinder chambers are interconnected;

[0030] The input port is communicated with the first cylinder chamber with a larger cylinder diameter; the output port is communicated with the second cylinder chamber with a smaller cylinder diameter;

[0031] The two cylinder chambers are isolated from each other. The two sliding members are directly connected by a connecting member. The two ends of the connecting member are hermetically inserted into the respective cylinder chambers and connected to the corresponding sliding members.

[0032] Optionally, the chamber wall of the second cylinder chamber is respectively provided with:

[0033] A sixth pressure regulating hole, which is communicated to one side of the sliding member in the second cylinder chamber; a seventh pressure regulating hole, which is communicated to the other side of the sliding member in the second cylinder chamber, and the output port is also communicated to this side.

[0034] Optionally, each pressure regulating hole is communicated with a regulating valve; each regulating valve is directly installed on the corresponding pressure regulating hole or communicated with the corresponding pressure regulating hole through an external pipeline.

[0035] Optionally, a balance chamber is further arranged in the housing, and the drive chamber is communicated with the balance chamber;

[0036] The output port of the pressurizing mechanism is communicated with the drive chamber and / or the balance chamber.

[0037] Optionally, the feedback-regulated hemostatic valve further includes an energy storage mechanism that can be linked with the fluid. The energy storage mechanism stores or releases energy correspondingly when the state of the sealing film changes, so as to drive the sealing film to close the instrument channel;

[0038] The fluid in the drive chamber is linked with the energy storage mechanism through the balance chamber;

[0039] The output of the pressurizing mechanism directly acts on the energy storage mechanism, or the output port of the pressurizing mechanism is communicated with the drive chamber and / or the balance chamber.

[0040] Optionally, the energy storage mechanism includes an elastic bladder placed in the balance chamber;

[0041] The output port of the pressurizing mechanism is communicated with the balance chamber.

[0042] Optionally, the energy storage mechanism includes an elastic bladder placed in the balance chamber;

[0043] The output port of the pressurizing mechanism is communicated with the elastic bladder.

[0044] Optionally, the energy storage mechanism includes:

[0045] An energy storage chamber communicated with the balance chamber;

[0046] A piston that seals and slides between the balance chamber and the energy storage chamber;

[0047] A compressible gas and / or elastic member that is located in the energy storage chamber and acts on the piston;

[0048] The output port of the pressurizing mechanism is communicated with the energy storage chamber.

[0049] Optionally, the energy storage mechanism includes:

[0050] An energy storage chamber communicated with the balance chamber;

[0051] A piston that seals and slides between the balance chamber and the energy storage chamber;

[0052] A compressible gas and / or elastic member that is located in the energy storage chamber and acts on the piston;

[0053] The output port of the pressurizing mechanism communicates with the balance chamber.

[0054] Optionally, it further includes a blood pressure indicating device connected to the input port.

[0055] Optionally, the blood pressure indicating device is a separately configured sphygmomanometer or integrated into the pressurizing mechanism.

[0056] Optionally, at least some of the moving parts in the pressurizing mechanism are related to blood pressure, and a blood pressure mark is provided in the pressurizing mechanism, and the blood pressure mark is related to the position of the moving parts.

[0057] Optionally, the pressurizing mechanism includes a support body, and two cylinder chambers with different cylinder diameters are arranged inside the support body. A sliding member is hermetically and slidably installed in each cylinder chamber, and the sliding members in the two cylinder chambers are interlocked with each other;

[0058] The input port communicates with the first cylinder chamber with a larger cylinder diameter; the output port communicates with the second cylinder chamber with a smaller cylinder diameter;

[0059] The moving parts are the sliding members in the first cylinder chamber and / or the sliding members in the second cylinder chamber.

[0060] Optionally, a hydrophilic lubricating coating is provided on the inner cavity of the sealing film.

[0061] This application also discloses a catheter sheath, which includes a tube body and a feedback-regulated hemostatic valve that are connected and communicated with each other. The feedback-regulated hemostatic valve is one of the above technical solutions.

[0062] Optionally, a pipe joint connected to the pipe body is provided on the feedback-regulated hemostatic valve. The pipe joint is matched with the pipe body through a sealing member, and a clamping structure for preventing the pipe body from separating from the pipe joint is provided on the pipe joint.

[0063] This application also discloses a method for sealing an interventional instrument, which includes constructing an instrument channel by using a deformable sealing film, deforming the sealing film through a fluid on the outer periphery of the sealing film to seal the instrument channel, and during the process of the interventional instrument entering and exiting the instrument channel, using a pressurizing mechanism to feedback the blood pressure change to the fluid to maintain the seal between the interventional instrument and the instrument channel.

[0064] Optionally, the method for sealing an interventional instrument is implemented by using the feedback-regulated hemostatic valve in the above technical solution.

[0065] The technical solution disclosed in this application, through the setting of a pressurizing mechanism, feeds back blood pressure changes to the fluid, thereby adaptively adjusting the sealing pressure of the sealing film, improving the effect of the sealing film closing the instrument channel during the movement of the interventional instrument relative to the sealing film, improving the operation experience of operators such as medical staff, providing a stable treatment process, and improving the treatment effect.

[0066] Specific beneficial technical effects will be further explained in combination with specific structures or steps in the specific implementation manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0067] Figure 1a Schematic diagram of the initial state of the hemostatic valve in an embodiment;

[0068] Figure 1b is Figure 1a Schematic diagram of the filling state of the hemostatic valve in

[0069] Figure 1c is Figure 1a Schematic diagram of the working state of the hemostatic valve in

[0070] Figure 2 Schematic diagram of another implementation manner of the pressurizing mechanism in an embodiment;

[0071] Figure 3 Schematic diagram of another connection mode of the pressurizing mechanism in an embodiment;

[0072] Figure 4a Schematic diagram of the pressurizing mechanism arranged in the hemostatic valve in an embodiment;

[0073] Figure 4b is Figure 4a Schematic diagram of another implementation manner of the hemostatic valve in

[0074] Figure 5a Schematic diagram of another energy storage mechanism adopted by the hemostatic valve in an embodiment;

[0075] Figure 5b is Figure 5a Schematic diagram of another connection mode of the pressurizing mechanism in the hemostatic valve in

[0076] Figure 6a and 6b Schematic diagram of the cooperation relationship between the tube body of the catheter sheath and the hemostatic valve.

[0077] The descriptions of the reference numerals in the drawings are as follows:

[0078] 1. Housing; 11. Instrument channel; 12. Driving chamber; 14. Blood pressure feedback hole;

[0079] 2. Sealing film; 21. Inner cavity;

[0080] 3. Energy storage mechanism; 31. Balance chamber; 34. Piston; 35. Elastic capsule; 33. Energy storage chamber;

[0081] 4. Pressure boosting mechanism; 40. Support body; 401. First cylinder chamber; 402. Second cylinder chamber; 41. Input port; 42. Output port; 43. First sliding member; 431. Input chamber; 432. Connecting member; 44. Second sliding member; 441. Output chamber; 442. Shared linkage chamber; 443. First linkage chamber; 444. Second linkage chamber; 451. Fourth pressure regulating hole; 452. Fifth pressure regulating hole; 453. Sixth pressure regulating hole; 454. Seventh pressure regulating hole;

[0082] 9. Interventional device; 91. Tube body. Detailed implementation manners

[0083] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

[0084] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0085] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments, and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0086] Referring to Figures 1a to 1c , the present application discloses a feedback-regulated hemostatic valve, including a housing 1 and a sealing film 2 installed in the housing 1 and having a tubular structure. The inner cavity 21 of the tubular structure serves as an instrument channel 11 and penetrates through the housing 1. A driving chamber 12 for filling fluid is provided in the housing 1 and is located outside the sealing film 2. The feedback-regulated hemostatic valve further includes a pressure boosting mechanism 4 for feeding back blood pressure changes to the fluid.

[0087] The function of the sealing film 2 actually separates two independent spaces within the housing 1, namely the instrument channel 11 and the driving chamber 12, and the two are isolated by the sealing film 2. The two ends of the instrument channel 11 are open for the instrument to pass through, so the sealing of the sealing film 2 refers to the sealing of the driving chamber 12.

[0088] The sealing film 2 itself is a tubular structure, and its inner cavity 21 serves as the instrument channel 11. In order to ensure that the instrument passes through the housing 1, the instrument channel 11 needs to penetrate the housing 1, and the actual length of the instrument channel 11 should be greater than the effective length of the housing 1 in the length direction of the instrument channel 11; in actual products, the sealing film 2 may be entirely disposed within the housing 1, and the effective length of the sealing film 2 in the length direction of the instrument channel 11 may be less than the effective length of the housing 1 in the length direction of the instrument channel 11; therefore, the inner cavity 21 of the sealing film 2 serving as the instrument channel 11 should be understood as the inner cavity 21 of the sealing film 2 constituting at least a part of the instrument channel 11, and the instrument channel 11 may extend in the length direction formed by the inner cavity 21 of the sealing film 2.

[0089] The tubular structure of the sealing film 2 mentioned in the present application is not limited to a strictly circular tube. In actual products, the inner diameter of the inner cavity of the sealing film 2 may vary axially. In cross-section, the inner cavity of the sealing film 2 may be a regular shape such as a rectangle, or may be a shape with variable edges such as a hourglass shape, a pear shape, a spherical shape, or may be an irregular variable shape.

[0090] In an embodiment, a hydrophilic lubricating coating (not shown in the figure) is provided on the inner cavity of the sealing film 2. The inner cavity of the sealing film 2 is the part that actually contacts the interventional instrument 9. The hydrophilic lubricating coating can reduce the friction of the inner cavity of the sealing film 2, facilitating the interventional instrument 9 to pass through the instrument channel 11 when there is a pressure difference inside and outside the sealing film 2. At the same time, the hydrophilic lubricating coating can also achieve other functions by adjusting the coating material. For example, adding wear-resistant materials to the coating material to increase the service life of the sealing film 2; for another example, adjusting the physical and chemical properties of the coating surface to achieve self-cleaning of the sealing film 2.

[0091] In terms of the interaction relationship, the driving chamber 12 can drive the sealing film 2 to change its own state, so as to realize the closing or opening of the instrument channel 11. The instrument channel 11 is a channel for the intervention instrument 9 (such as a catheter, a guide wire, etc.) to enter and exit the human body during the interventional treatment process. Therefore, it can be understood that the area surrounded by the tubular structure is at least part of the instrument channel 11. To cooperate with the entry of the intervention instrument 9, corresponding inlets and outlets communicating with the instrument channel 11 are opened on the housing 1, and it can also be regarded that the instrument channel 11 penetrates through the housing 1. The function of the driving chamber 12 is to confine the fluid and guide the work done by the fluid to the sealing film 2. When the sealing film 2 closes the instrument channel 11, at least a part of the tubular structure of the sealing film 2 itself will generate a radial contraction trend, so as to reduce the lumen diameter of the instrument channel 11 until the instrument channel 11 is closed. Whether the instrument is in the instrument channel 11 or not, the sealing film 2 can realize the closing or opening of the instrument channel 11.

[0092] When the intervention instrument is in the instrument channel 11, the inner cavity 21 of the sealing film 2 radially contracts to cooperate with the instrument to close the instrument channel 11.

[0093] When the intervention instrument is not in the instrument channel 11, the inner cavity 21 of the sealing film 2 radially contracts until it closes itself by adhering to each other to close the instrument channel 11.

[0094] Analyzed from the principle, the fluid drives the sealing film 2 mainly through pressure. When the fluid pressure in the driving chamber 12 is sufficient to overcome the resistance in the instrument channel 11, the driving chamber 12 can drive the sealing film 2 to deform itself to change the inner cavity 21 of the sealing film 2. Specifically, the closing effect of the instrument channel 11 depends on the magnitude of the fluid pressure in the driving chamber 12. The magnitude of the fluid pressure in the driving chamber 12 can be changed in various forms, such as connecting an external pressure source, changing the fluid temperature, changing the physical properties of the fluid, etc. In this embodiment, the pressurizing mechanism 4 feeds back the blood pressure at one end of the feedback-regulated hemostatic valve to the fluid, thereby changing the fluid pressure in the driving chamber 12, further adjusting the working state of the sealing film 2, and thus adjusting the closing effect of the instrument channel 11. This design can improve the effect of the sealing film 2 closing the instrument channel 11 during the movement of the intervention instrument 9 relative to the sealing film 2, improve the operation experience of operators such as medical staff, provide a stable treatment process, and improve the treatment effect.

[0095] The housing 1 can restrict the work done by the drive chamber 12 in other directions, thereby ensuring that all the energy of the fluid acts on the sealing membrane 2. When the energy is constant, the stroke of the deformation of the sealing membrane 2 and the sealing effect are improved. The rigidity mentioned in this embodiment is relative to the deformable flexible sealing membrane 2, rather than the rigidity of a rigid body in the physical concept. In an actual product, the housing 1 may be made of materials such as plastic, and may undergo slight deformation under the action of the fluid, but this slight deformation will not affect the working effect of the sealing membrane 2. The same applies to the description of rigidity hereinafter. In different products, the housing 1 may be made of common materials such as metal and plastic, or may be organic materials or inorganic materials; it may also be synthetic materials or natural materials, etc.

[0096] In the specific setting of the pressurizing mechanism 4, in one embodiment, the pressurizing mechanism 4 has an input port 41 for collecting blood pressure and an output port 42 after pressurization. The output of the pressurizing mechanism 4 directly or indirectly acts on the fluid in the drive chamber 12.

[0097] The energy input of the increasing mechanism comes from blood pressure, so a connection needs to be established with the human body interior. In the usage scenario of the feedback-regulated hemostatic valve, the blood environment inside the human body is easily connected. Therefore, the pressurizing mechanism 4 can feedback blood pressure changes to the fluid through a simple connection relationship. During the feedback process, the pressurizing mechanism 4 can act directly on the fluid or be indirectly linked through the transmission between components.

[0098] From the perspective of the structure of the increasing mechanism, in one embodiment, the pressurizing mechanism 4 includes a support body 40. Inside the support body 40, there are two cylinder chambers with different cylinder diameters. A sliding member is hermetically and slidably installed in each cylinder chamber, and the sliding members in the two cylinder chambers are interconnected;

[0099] The input port 41 communicates with the first cylinder chamber 401 with a larger cylinder diameter; the output port 42 communicates with the second cylinder chamber 402 with a smaller cylinder diameter.

[0100] The support body 40 provides a stable working environment, and the two cylinder chambers can restrict the working stroke of their respective sliding members. The sliding member realizes energy transfer by acting on the fluid in the corresponding cylinder chamber. It should be noted that the larger and smaller in the first cylinder chamber 401 with a larger cylinder diameter and the second cylinder chamber 402 with a smaller cylinder diameter refer to the result of the comparison between the first cylinder chamber 401 and the second cylinder chamber 402. The same applies hereinafter.

[0101] The different cylinder diameters of the two cylinder chambers can achieve the effect of pressure regulation. According to the needs of the actual product, the feedback relationship between blood pressure and the fluid is adjusted.

[0102] The linkage between the sliding members in the two cylinder chambers can be achieved in various forms. For example, in one embodiment, the sliding members in the two cylinder chambers are connected through a solid component; for another example, the linkage is achieved by filling with a fluid. In one embodiment, the two cylinder chambers communicate with each other, and at the communicating part is a linkage chamber located between the two sliding members, and the two sliding members are interlinked through the medium pressure in the common linkage chamber 442; for yet another example, the linkage is achieved through an energy field or a force field. In one embodiment, the sliding members in the two cylinder chambers are interlinked through a magnetic field.

[0103] Regarding the specific distribution relationship between the two cylinder chambers, referring to Figure 4a , in one embodiment, the sliding member in the first cylinder chamber 401 is the first sliding member 43. One side of the first sliding member 43 is an input chamber 431 communicating with the input port 41, and the other side is the common linkage chamber 442;

[0104] The sliding member in the second cylinder chamber 402 is the second sliding member 44. One side of the second sliding member 44 is an output chamber 441 communicating with the output port 42, and the other side is the common linkage chamber 442.

[0105] The function of the common linkage chamber 442 is to provide a movement space for the linkage relationship between the sliding members in the two cylinder chambers. During the movement of the sliding members in the two cylinder chambers, changes may occur among the input chamber 431, the common linkage chamber 442, and the output chamber 441. For example, when the first sliding member 43 is driven by blood pressure to move towards the second sliding member 44, the part originally belonging to the common linkage chamber 442 will be compressed and become the space of the input chamber 431.

[0106] The common linkage chamber 442 can also be redesigned to become an independent linkage chamber. Referring to Figure 2 , in one embodiment, the two cylinder chambers are isolated from each other, and the two sliding members are directly connected by a connecting member 432. The two ends of the connecting member 432 are hermetically inserted into the respective cylinder chambers and connected to the corresponding sliding members.

[0107] In one embodiment, the sliding member in the first cylinder chamber 401 is the first sliding member 43. One side of the first sliding member 43 is an input chamber 431 communicating with the input port 41, and the other side is the first linkage chamber 443;

[0108] The sliding member in the second cylinder chamber 402 is the second sliding member 44. One side of the second sliding member 44 is an output chamber 441 communicating with the output port 42, and the other side is the second linkage chamber 444;

[0109] The two ends of the connecting member 432 are hermetically inserted into the respective linkage chambers and connected to the corresponding sliding members.

[0110] The design method of the split linkage chamber can facilitate the arrangement of the pressurizing mechanism 4, thereby providing a structural basis for the feedback regulation type hemostatic valve to adjust the overall shape for different treatment cases.

[0111] The energy source of the pressurizing mechanism 4 comes from blood pressure. In terms of the setting of the input mode, in one embodiment, the feedback-regulated hemostatic valve is provided with a blood pressure feedback hole 14 that can communicate with blood vessels in the use state, and the blood pressure feedback hole 14 is connected to the input port 41 through a feedback pipeline.

[0112] The blood pressure feedback hole 14 can realize the transmission of the pressure of blood pressure to the pressurizing mechanism 4, so as to realize the energy transmission of blood pressure to the pressurizing mechanism 4.

[0113] In principle, the blood pressure feedback hole 14 should be designed on the side of the feedback-regulated hemostatic valve close to the human body to meet the use requirements of the pressurizing mechanism 4 while stopping bleeding. Specifically, in one embodiment, one end of the instrument channel 11 is the instrument inlet, and the other end is the instrument outlet, and the blood pressure feedback hole 14 is adjacent to the side of the instrument outlet.

[0114] The side of the instrument outlet is closer to the human body. The blood pressure feedback hole 14 adjacent to the instrument outlet can facilitate the connection with the blood of the human body. And the energy transmission of blood pressure and the pressurizing mechanism 4 can be realized through a shorter pipeline, improving the working effect of the pressurizing mechanism 4 under dynamic working conditions.

[0115] In one embodiment, the feedback-regulated hemostatic valve is provided with an exhaust hole (not shown in the figure), and the exhaust hole and the blood pressure feedback hole 14 are separately configured.

[0116] When medical devices such as catheters inserted into the body are in use, it is usually necessary to remove the gas in the device. The exhaust hole can overcome the problem of the gas carried by the device before use. At the same time, the operator can remove the gas in the hemostatic valve by injecting physiological saline into the exhaust hole 16 before use. Further, the exhaust hole itself is also an interface, which can provide a structural basis for special operations in special use scenarios. Whether the exhaust hole and the blood pressure feedback hole 14 are separately configured has different advantages and limitations, and can be set as needed. For example, separately configuring the exhaust hole and the blood pressure feedback hole 14 can avoid the influence of the gas in the exhaust hole on the blood and improve safety. In some products, the exhaust hole and the blood pressure feedback hole 14 can also be configured together. In one embodiment, the feedback-regulated hemostatic valve is provided with an exhaust hole, which also serves as the blood pressure feedback hole 14, and an exhaust bypass is connected to the feedback pipeline, and an exhaust valve is provided on the exhaust bypass.

[0117] The exhaust hole also serving as the blood pressure feedback hole 14 can improve the component integration degree of the feedback-regulated hemostatic valve, and ensure the overall volume of the feedback-regulated hemostatic valve while increasing functions. The gas discharged by the exhaust valve can also be used for the pressurizing mechanism 4 to achieve a better sealing effect of the instrument channel 11. However, correspondingly, structures such as one-way valves are required to avoid the influence of the gas discharged by the exhaust valve on the blood in the human body.

[0118] The flexible setting of the exhaust valve can be adjusted according to the usage requirements of different cases. For example, the design of directly installing the exhaust valve on the exhaust hole can improve the integration of the feedback-regulated hemostatic valve, facilitating operation by medical staff and other operators; for another example, the design of connecting the exhaust valve to the exhaust hole through an external pipeline can further reduce the external dimensions of the feedback-regulated hemostatic valve and provide adaptability.

[0119] In terms of the installation method of the pressurizing mechanism 4, in one embodiment, the support body 40 and the housing 1 are of an integral or split structure.

[0120] Reference Figure 2 , the split support body 40 and the housing 1 can achieve flexible arrangement of the pressurizing mechanism 4 relative to the housing 1, thereby providing a more flexible feedback-regulated hemostatic valve performance at the intervention site and improving adaptability; reference Figure 1a and Figure 4a , the integral support body 40 and the housing 1 can achieve the integration of the pressurizing mechanism 4 and the housing 1, reducing the settings of connected pipelines, etc., facilitating the use experience of medical staff and other operators, and at the same time reducing the possible failure links, especially the pipeline part with pressure.

[0121] In terms of the internal setting details of the increasing mechanism, in one embodiment, the two cylinder chambers are arranged coaxially, side by side, or nested inside and outside.

[0122] The different arrangements of the two cylinder chambers can bring different technical effects. For example, the coaxially arranged two cylinder chambers can facilitate the linkage setting between the two sliding parts, thereby reducing the production and assembly difficulty; for example, the side-by-side arranged two cylinder chambers can effectively control the length of the pressurizing mechanism 4 in the sliding direction of the sliding part and improve the overall spatial performance of the feedback-regulated hemostatic valve; for example, the internally and externally nested arranged two cylinder chambers can effectively control the dimensions of the pressurizing mechanism 4 in the sliding direction of the sliding part and in the radial direction perpendicular to the sliding direction of the sliding part, further improving the overall spatial performance of the feedback-regulated hemostatic valve; the specific setting method can be set as needed according to different application scenarios of the feedback-regulated hemostatic valve.

[0123] From another dimension, in one embodiment, the axes of the two cylinder chambers are parallel, skew, or perpendicular.

[0124] The function of the two cylinder chambers is to convey the pressure of the blood to the fluid. The setting of the axis direction does not affect the realization of the functions of the two cylinder chambers. It is more a consideration of the overall layout structure of the feedback-regulated hemostatic valve. In actual products, it may be set as needed. For example, the design with the axes of the two cylinder chambers parallel to each other can obtain a more regular overall shape; for another example, the design with the axes of the two cylinder chambers at an oblique angle or perpendicular can achieve a more compact and practical overall shape in some products with special needs.

[0125] Regardless of the arrangement form of the two cylinder chambers, the ultimate purpose of the pressurizing mechanism 4 is to deliver the pressure of the blood to the fluid. In one embodiment, the output port 42 of the pressurizing mechanism 4 is communicated with the driving chamber 12.

[0126] The driving chamber 12 is a cavity that directly drives the deformation of the sealing film 2. Therefore, the communication between the output port 42 of the pressurizing mechanism 4 and the driving chamber 12 can directly reflect the blood pressure change to the fluid in the driving chamber 12, thus bringing a more sensitive working effect.

[0127] Reference Figure 4a and Figure 4b and, the pressurizing mechanism 4 can be integrated into the hemostatic valve. In addition to the mutual linkage between the two sliding members of the pressurizing mechanism 4 through the connecting member 432, they are communicated through the medium pressure between them. Specifically, in one embodiment, the pressurizing mechanism 4 includes a support body 40. Two cylinder chambers with different cylinder diameters are arranged inside the support body 40. A sliding member is hermetically and slidably installed in each cylinder chamber, and the sliding members in the two cylinder chambers are mutually linked;

[0128] The input port 41 is communicated with the first cylinder chamber 401 with a larger cylinder diameter; the output port 42 is communicated with the second cylinder chamber 402 with a smaller cylinder diameter;

[0129] The two cylinder chambers are mutually communicated. The communication part is a linkage chamber located between the two sliding members. The two sliding members are mutually linked through the medium pressure in the linkage chamber.

[0130] The two sliding members linked by the medium pressure can liberate the physical size constraint of the connecting member 432, so as to be arranged more flexibly. More importantly, the medium pressure can be adjusted flexibly during the treatment process, thus bringing more diverse usage methods.

[0131] In one embodiment, a fourth pressure regulating hole 451 communicated with the linkage chamber is opened on the chamber wall of the linkage chamber; on the chamber wall of the cylinder chamber with a smaller cylinder diameter, a fifth pressure regulating hole 452 communicated with the output port 42 is opened.

[0132] The fourth pressure regulating hole 451 can adjust the medium pressure in the linkage chamber, thereby changing the linkage relationship between the two sliding members. For example, when the medium pressure in the linkage chamber is relatively high, the linkage relationship between the two sliding members is closer to a rigid transmission. In scenarios where the blood pressure changes rapidly or within a large range, etc., the pressurizing mechanism 4 has better dynamic response performance; for another example, when the medium pressure in the linkage chamber is relatively low, the linkage relationship between the two sliding members is closer to a flexible transmission, and the movement energy of parts such as the two sliding members is absorbed by the medium in the linkage chamber, thereby providing a more compliant working effect for the pressurizing mechanism 4.

[0133] The fifth pressure regulating hole 452 is more direct than the fourth pressure regulating hole 451 and can directly regulate the pressure of the output port 42, thereby directly regulating the working result of the pressurizing mechanism 4 through an external pressure source, providing more abundant adjustment options for the feedback-regulated hemostatic valve.

[0134] Correspondingly, the pressure regulating hole can also be arranged on the pressurizing mechanism 4 linked by the connecting member 432. In one embodiment, the pressurizing mechanism 4 includes a support body 40, and two cylinder chambers with different cylinder diameters are arranged inside the support body 40. A sliding member is hermetically and slidably installed in each cylinder chamber, and the sliding members in the two cylinder chambers are linked to each other;

[0135] The input port 41 communicates with the first cylinder chamber 401 with a larger cylinder diameter; the output port 42 communicates with the second cylinder chamber 402 with a smaller cylinder diameter;

[0136] The two cylinder chambers are isolated from each other, and the two sliding members are directly connected by a connecting member 432. Both ends of the connecting member 432 penetrate into each cylinder chamber hermetically and are connected to the corresponding sliding member.

[0137] Specifically, in one embodiment, the wall of the second cylinder chamber 402 is respectively provided with:

[0138] A sixth pressure regulating hole 453, which communicates with one side of the sliding member in the second cylinder chamber 402; a seventh pressure regulating hole 454, which communicates with the other side of the sliding member in the second cylinder chamber 402, and the output port 42 also communicates with this side.

[0139] The sixth pressure regulating hole 453 regulates the pressure of the input port 41, and the seventh pressure regulating hole 454 regulates the pressure of the output port 42, which can bring more abundant adjustment options.

[0140] Among them, the fourth pressure regulating hole 451, the fifth pressure regulating hole 452, the sixth pressure regulating hole 453 and the seventh pressure regulating hole 454 are also interfaces themselves, which can provide a structural basis for special operations in special usage scenarios.

[0141] In one embodiment, each pressure regulating hole is communicated with a regulating valve; each regulating valve is directly installed on the corresponding pressure regulating hole or is communicated with the corresponding pressure regulating hole through an external pipeline.

[0142] The flexible setting of the regulating valve can be adjusted according to the usage needs of different cases. For example, the design of directly installing the regulating valve on the pressure regulating hole can improve the integration of the feedback-regulated hemostatic valve and facilitate the operation of operators such as medical staff; for another example, the design of communicating the regulating valve with the pressure regulating hole through an external pipeline can further reduce the external size of the feedback-regulated hemostatic valve and provide adaptability.

[0143] In one embodiment, a balance chamber 31 is further provided inside the housing 1, and the driving chamber 12 communicates with the balance chamber 31;

[0144] The output port 42 of the pressurizing mechanism 4 communicates with the driving chamber 12 and / or the balance chamber 31.

[0145] The balance chamber 31 is a division of a functional area. The balance chamber 31 can be an independent cavity from the driving chamber 12 and is only connected by a pipeline, or they can share a physical cavity but have different functions.

[0146] In terms of the function of the balance chamber 31, in one embodiment, the feedback-regulated hemostatic valve further includes an energy storage mechanism 3 that can be linked with the fluid. The energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing film 2 changes, so as to drive the sealing film 2 to close the instrument channel 11;

[0147] The fluid in the driving chamber 12 is linked with the energy storage mechanism 3 via the balance chamber 31;

[0148] The output of the pressurizing mechanism 4 directly acts on the energy storage mechanism 3, or the output port 42 of the pressurizing mechanism 4 communicates with the driving chamber 12 and / or the balance chamber 31.

[0149] When the interventional instrument 9 enters the feedback-regulated hemostatic valve, the sealing film 2 needs to open the instrument channel 11 to avoid interfering with the interventional instrument 9. Therefore, the sealing film 2 does work on the fluid in the driving chamber 12. If the preset pressure of the fluid in the driving chamber 12 is too high, the driving force required for the deformation of the sealing film 2 will be too high, and the interventional instrument 9 needs a large driving force to squeeze the sealing film 2 to open the instrument channel 11, which will affect the use of operators such as medical staff; if the preset pressure of the fluid in the driving chamber 12 is too low, the sealing pressure of the sealing film 2 in the state of closing the instrument channel 11 will be insufficient, and it is easy to cause the situation of sealing failure.

[0150] The energy storage mechanism 3 in this embodiment can well overcome the above problems. When the interventional instrument 9 enters the feedback-regulated hemostatic valve, the sealing film 2 needs to open the instrument channel 11 to avoid interfering with the interventional instrument 9. At this time, the sealing film 2 does work on the fluid in the driving chamber 12, and at the same time the energy storage mechanism 3 stores energy to absorb the energy of the fluid to reduce the entry difficulty of the interventional instrument 9 and provide a good feel for the entry process of the instrument; when the interventional instrument 9 exits the feedback-regulated hemostatic valve, the sealing film 2 needs to close the instrument channel 11 to perform the function of the feedback-regulated hemostatic valve. At this time, the fluid in the driving chamber 12 does work on the sealing film 2, and at the same time the energy storage mechanism 3 releases energy to perform work on the fluid to ensure the sealing effect of the sealing film 2 on the instrument channel 11. The cooperation of the pressurizing mechanism 4 and the energy storage mechanism 3 can further balance the sealing effect of the instrument channel 11 and the feel when the interventional instrument 9 enters the feedback-regulated hemostatic valve.

[0151] ReferenceFigure 5a and Figure 5b In one embodiment, the energy storage mechanism 3 includes an elastic bladder 35 disposed in the balance chamber 31;

[0152] The output port 42 of the pressurizing mechanism 4 communicates with the balance chamber 31.

[0153] The elastic bladder 35 can store or release energy, increasing the energy storage or release capacity of the energy storage skill. The output port 42 of the pressurizing mechanism 4 communicates with the balance chamber 31. During the energy release process, in addition to the elasticity of the sealing membrane 2 itself, the elastic bladder 35 and the pressurizing mechanism 4 can cooperate to do work to supplement the energy of the fluid. The output port 42 of the pressurizing mechanism 4 can also be arranged in other ways. In one embodiment, the energy storage mechanism 3 includes an elastic bladder 35 disposed in the balance chamber 31; the output port 42 of the pressurizing mechanism 4 communicates with the elastic bladder 35.

[0154] When the output port 42 of the pressurizing mechanism 4 communicates with the elastic bladder 35, the energy output by the pressurizing mechanism 4 is released through the elastic bladder 35. The elastic bladder 35, as the energy storage component of the energy storage mechanism 3, can buffer the energy released by the pressurizing mechanism 4, thereby providing a smoother performance for the pressure change of the fluid and improving the overall working effect of the feedback-regulated hemostatic valve.

[0155] Correspondingly, the energy storage mechanism 3 can also be arranged in other ways. Refer to Figures 1a to 1c In one embodiment, the energy storage mechanism 3 includes:

[0156] An energy storage chamber 33 communicating with the balance chamber 31;

[0157] A piston 34 sealingly sliding between the balance chamber 31 and the energy storage chamber 33;

[0158] Compressible gas and / or elastic member disposed in the energy storage chamber 33 and acting on the piston 34;

[0159] The output port 42 of the pressurizing mechanism 4 communicates with the energy storage chamber 33.

[0160] In this technical solution, the pressurizing mechanism 4 actually shares the component structure with the energy storage mechanism 3. The linkage chamber functions as the energy storage chamber 33, and the second cylinder chamber 402 functions as the balance chamber 31. The position change of the piston 34 realizes the energy storage or release of the energy storage mechanism 3. During the energy storage process, energy is absorbed by the compressible gas and / or elastic member. During the energy release process, the compressible gas and / or elastic member do work to achieve energy release. The energy storage chamber 33 is a functional description of the energy storage mechanism 3 during the energy storage process. During the energy release process, the energy storage chamber 33 actually functions as energy release.

[0161] The output port 42 of the pressurizing mechanism 4 is communicated with the energy storage chamber 33. During the energy release process, the energy output by the pressurizing mechanism 4 is released through the piston 34. The piston 34 can buffer the energy released by the pressurizing mechanism 4, thereby providing a smoother performance for the pressure change of the fluid and improving the overall working effect of the feedback-regulated hemostatic valve. The output port 42 of the pressurizing mechanism 4 can also be arranged in other ways.

[0162] Reference Figure 3 , in one embodiment, the energy storage mechanism 3 includes:

[0163] An energy storage chamber 33 communicated with the balance chamber 31;

[0164] A piston 34 that seals and slides between the balance chamber 31 and the energy storage chamber 33;

[0165] Compressible gas and / or elastic member located in the energy storage chamber 33 and acting on the piston 34;

[0166] The output port 42 of the pressurizing mechanism 4 is communicated with the balance chamber 31.

[0167] The output port 42 of the pressurizing mechanism 4 is communicated with the balance chamber 31. During the energy release process, in addition to the elasticity of the sealing film 2 itself, the elastic bladder 35 and the pressurizing mechanism 4 can cooperate to supplement the energy of the fluid. The output effect of the pressurizing mechanism 4 is more direct, which is more suitable for some products that require better dynamic performance.

[0168] The structure of the pressurizing mechanism 4 communicating with the human blood can also provide a basis for other functions. In one embodiment, the feedback-regulated hemostatic valve further includes a blood pressure indicating device (not shown in the figure) connected to the input port 41.

[0169] Blood pressure is an important indicator during the treatment process. Compared with the monitoring device that separately configures sensors and output devices, the blood pressure indicating device realized by the pressurizing mechanism 4 has a simple structure, is stable and easy to read, and is convenient to implement.

[0170] In terms of the reading method of the blood pressure indicating device, in one embodiment, the blood pressure indicating device is a separately configured sphygmomanometer or integrated into the pressurizing mechanism 4.

[0171] In one embodiment, at least the moving parts related to blood pressure are provided in the pressurizing mechanism 4, and a blood pressure mark is provided in the pressurizing mechanism 4, and the blood pressure mark is related to the position of the moving parts.

[0172] In one embodiment, the pressurizing mechanism 4 includes a support body 40. Two cylinder chambers with different cylinder diameters are arranged inside the support body 40. A sliding member is hermetically and slidably installed in each cylinder chamber, and the sliding members in the two cylinder chambers are interlocked with each other;

[0173] The input port 41 is connected to the first cylinder chamber 401 with a larger cylinder diameter; the output port 42 is connected to the second cylinder chamber 402 with a smaller cylinder diameter.

[0174] The moving part is a slider in the first cylinder chamber 401 and / or a slider in the second cylinder chamber 402.

[0175] Reference Figures 6a to 6b Furthermore, the present application also discloses a catheter sheath, which includes a tube body 91 and a feedback-regulated hemostatic valve that are connected and communicated with each other. The feedback-regulated hemostatic valve is one of the above technical solutions.

[0176] The tube body 91 intervenes into the human body. The hemostatic valve seals the tube body. The interventional device 9 enters the tube body 91 through the feedback-regulated hemostatic valve and thus enters the human body to perform the treatment process.

[0177] In one embodiment, the feedback-regulated hemostatic valve is provided with a pipe joint connected to the tube body 91. The pipe joint is matched with the tube body 91 through a seal, and the pipe joint is provided with a clamping structure to prevent the separation of the tube body 91 and the pipe joint. In this embodiment, the pipe joint is formed by extending from the second end cap 15. Through the cooperation of the clamping structure, the rapid assembly of the tube body 91 and the hemostatic valve can be achieved, and the separation in case of emergency can also be realized.

[0178] In terms of specific detailed operations, the head of the tube body 91 is provided with a radiopaque point, which is convenient for medical staff to better complete the surgical process with the help of medical equipment.

[0179] During the use of the feedback-regulated hemostatic valve, the connected and communicated tube body 91 and the hemostatic valve jointly form an instrument channel 11, where the tube body 91 can be integrally or separately arranged with the end caps on both sides. Each end cap extends away from the hemostatic valve, so as to extend in the axial direction of the instrument channel 11 to further wrap and protect the instrument channel 11 for the interventional device 9 to pass through.

[0180] The present application also discloses a method for sealing an interventional device, which includes constructing an instrument channel by using a deformable sealing film, driving the deformation of the sealing film through a fluid on the outer periphery of the sealing film to seal the instrument channel. The characteristic lies in that during the process of the interventional device entering and exiting the instrument channel, an energy storage mechanism linked with the fluid stores or releases energy correspondingly when the sealing film deforms, so as to maintain the seal between the interventional device and the instrument channel.

[0181] In one embodiment, the method for sealing the interventional device is implemented according to the feedback-regulated hemostatic valve in the above technical solution. For the specific structural details of the hemostatic valve, reference can be made to the description of the feedback-regulated hemostatic valve in the above text, which will not be elaborated here.

[0182] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered to be within the scope described in this specification. When the technical features in different embodiments are embodied in the same drawing, the drawing can be regarded as also disclosing the combination examples of the various embodiments involved.

[0183] The above-described embodiments only represent several implementation manners of the present application, and the description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application.

Claims

1. Feedback-regulated hemostatic valve, comprising a housing and a sealing membrane installed in the housing and having a tubular structure. The inner cavity of the tubular structure serves as an instrument channel. A drive chamber for filling fluid is provided in the housing and is located outside the sealing membrane. It is characterized in that, The driving chamber confines the fluid and guides the work done by the fluid to the sealing film. When the sealing film closes the instrument channel, at least a part of the tubular structure of the sealing film itself has a tendency to radially contract; the feedback-regulated hemostatic valve further includes a pressurizing mechanism for feeding back blood pressure changes to the fluid; The pressurizing mechanism has an input port for collecting blood pressure and an output port after pressurization. The output of the pressurizing mechanism directly or indirectly acts on the fluid in the driving chamber. The pressurizing mechanism includes a support body. Inside the support body, there are two cylinders with different bore diameters. A sliding member is hermetically and slidably installed in each cylinder, and the sliding members in the two cylinders are interconnected; the input port communicates with the first cylinder; the output port communicates with the second cylinder, and the bore diameter of the first cylinder is larger than that of the second cylinder.

2. The feedback-regulated hemostatic valve according to claim 1, characterized in that The two cylinders communicate with each other, and the communicating part is a linkage chamber located between the two sliding members. The two sliding members are interconnected through the medium pressure in the common linkage chamber.

3. The feedback-regulated hemostatic valve according to claim 2, wherein, The sliding member in the first cylinder is the first sliding member. One side of the first sliding member is an input chamber communicating with the input port, and the other side is the common linkage chamber; The sliding member in the second cylinder is the second sliding member. One side of the second sliding member is an output chamber communicating with the output port, and the other side is the common linkage chamber.

4. The feedback-regulated hemostatic valve according to claim 1, characterized in that, The two cylinders are isolated from each other, and the two sliding members are directly connected by a connecting member. Both ends of the connecting member are hermetically inserted into the respective cylinders and connected to the corresponding sliding members.

5. The feedback-regulated hemostatic valve according to claim 1, characterized in that It further includes a blood pressure indicating device connected to the input port.

6. The catheter sheath includes a tube body and a feedback-regulated hemostatic valve that are butt-connected and communicated with each other, characterized in that, The feedback-regulated hemostatic valve is the feedback-regulated hemostatic valve according to any one of claims 1 to 5.

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