Multi-chamber hemostatic valve and catheter sheath

Abstract

The present application discloses a hemostatic valve with multiple cavities and a catheter sheath. The hemostatic valve includes a housing and a sealing film installed in the housing and having a tubular structure. The inner cavity of the tubular structure serves as an instrument channel. Along the radial direction of the instrument channel, a driving chamber for filling fluid is provided in the housing outside the sealing film, and a balance chamber is located outside the driving chamber. The driving chamber and the balance chamber are interconnected, and the balance chamber surrounds the outer periphery of the driving chamber. The hemostatic valve further includes an energy storage mechanism that can be linked with the fluid. The fluid in the driving chamber is linked with the energy storage mechanism through the balance chamber. The energy storage mechanism stores or releases energy correspondingly when the state of the sealing film changes, and drives the sealing film to seal the instrument channel when releasing energy. Through the design of the energy storage mechanism, the present application stores the deformation energy of the sealing film, thereby achieving good compatibility when different instruments pass through, good sealing effect, and providing a structural basis for other functions.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to a hemostatic valve with multiple cavities and a catheter sheath. Background Art

[0002] Interventional therapy is a cutting-edge treatment technology developed in recent years that lies between drug use and surgical operations. Interventional therapy techniques usually require the use of medical imaging devices such as X-ray fluoroscopy, CT positioning, and B-ultrasound machines as a guide to deliver a catheter device loaded with interventional instruments (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 with existing technical solutions is the contradiction between the sealing function of the hemostatic valve and the penetrability function that facilitates the passage of interventional instruments. 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 instrument 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 filler into the sealed cavity to achieve 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 instrument. To facilitate the operation of adjusting the position of the interventional instrument relative to 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 hemostatic valve with multiple cavities, including 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 passage. Along the radial direction of the instrument passage, a driving chamber for filling fluid is provided inside the housing outside the sealing film, and a balance chamber is located outside the driving chamber. The driving chamber and the balance chamber are interconnected with each other, and the balance chamber surrounds the outer periphery of the driving chamber.

[0006] The hemostatic valve further includes an energy storage mechanism that can be linked with the fluid. The fluid in the driving chamber is linked with the energy storage mechanism through the balance chamber. The energy storage mechanism stores or releases energy correspondingly when the state of the sealing film changes, and drives the sealing film to seal the instrument passage when releasing energy.

[0007] The following also provides several optional methods, which are not additional limitations to the above overall solution, but merely further supplements or optimizations. Without technical or logical contradictions, each optional method can be combined separately with the above overall solution, or multiple optional methods can be combined with each other.

[0008] Optionally, there are multiple balance chambers and they are arranged at intervals on the outer periphery of the drive chamber, and the energy storage mechanism is configured for each balance chamber respectively.

[0009] Optionally, the number of the balance chambers is 2 to 8.

[0010] Optionally, the balance chambers are evenly arranged at intervals on the outer periphery of the drive chamber.

[0011] Optionally, each balance chamber communicates with the drive chamber through an independent balance hole.

[0012] Optionally, at least two balance chambers share the same balance hole to communicate with the drive chamber.

[0013] Optionally, each balance chamber communicates with the drive chamber through the same balance hole.

[0014] Optionally, a cylindrical space is formed in the housing, and the energy storage mechanism includes:

[0015] A piston, slidably arranged in the cylindrical space, and separating the cylindrical space into the balance chamber and the energy storage chamber;

[0016] An energy storage element, located in the energy storage chamber, and the energy storage element is a gas and / or an elastic member that acts on the piston.

[0017] Optionally, the housing is annular and has an annular wall, and the cylindrical space is located within the annular wall.

[0018] Optionally, the cylindrical space is a straight cylinder structure, and the axis of the straight cylinder structure is parallel to the axis of the housing.

[0019] Optionally, the instrument channel penetrates the housing along the axis of the housing.

[0020] Optionally, the number of the cylindrical spaces is 2 to 8.

[0021] Optionally, the cylindrical spaces are sequentially distributed along the circumferential direction of the housing.

[0022] Optionally, each piston is in sealing cooperation with the inner wall of the corresponding cylindrical space through a sealing edge on its outer edge, and in the sliding direction of the piston, there are at least two seals between the sealing edge and the inner wall of the cylindrical space.

[0023] Optionally, at least two cylindrical spaces for the piston to slide are provided on the housing, and independent energy storage elements are provided in each cylindrical space, and the energy storage performances of the energy storage elements are the same or different.

[0024] Optionally, the hemostatic valve further includes a pressure regulating structure, and the pressure regulating structure is provided with a fluid pipeline for providing the fluid, and the fluid pipeline is directly or indirectly communicated with the balance chamber or the driving chamber or the balance hole.

[0025] Optionally, a plurality of balance chambers are provided and circumferentially distributed outside the driving chamber, and each balance chamber is communicated with the driving chamber through an independent balance hole; one side of each balance hole is linked with the driving chamber, and the other side extends radially to the outer peripheral wall of the housing, and each balance hole is closed on the outer peripheral wall or docked with the fluid pipeline.

[0026] Optionally, at least the outer periphery of the driving chamber of the housing is a rigid structure.

[0027] Through the design of the energy storage mechanism in the technical solution disclosed in the present application, the deformation energy of the sealing film is stored, and the posture and shape of the sealing film can be adaptively adjusted during the relative displacement between the instrument and the hemostatic valve, so as to achieve good compatibility and good sealing effect when different instruments pass through; through the setting of the parameters of the sealing film itself, the parameters of the energy storage structure, and the matching between the two, the advantages of good pulling operation feeling of the instrument and small change in the operation force are realized, and a structural basis is provided for adjusting the hand feeling of the pulling instrument.

[0028] The present invention also discloses a catheter sheath, including a sheath tube extending axially, the sheath tube having an axially penetrating cavity, the sheath tube having a proximal end and a distal end, and the proximal end of the sheath tube is connected with the above-mentioned hemostatic valve.

[0029] Optionally, a pipe joint for connecting with the sheath tube is provided on the hemostatic valve, the pipe joint is matched with the sheath tube through a seal, and the pipe joint is provided with a clamping structure for preventing the sheath tube from separating from the pipe joint.

[0030] Optionally, the distal end of the sheath tube has a radiopaque ring.

[0031] The present application also discloses a sheath tube, including a tube wall, the tube wall is a rolled wall structure, the cross section is coiled, and the tube wall has an expanded state in which the corresponding part of the rolled wall structure is expanded and a pre-shaped state in which the rolled wall structure is self-restored.

[0032] Optionally, the tube wall is made of an elastic material that can automatically switch between the expanded state and the pre-shaped state.

[0033] Optionally, the outer diameter of the tube wall in the pre-shaped state is 4-9 mm.

[0034] Optionally, the tube wall in the pre-shaped state is wound around more than one circumference, and the part exceeding the 360-degree circumference overlaps with the part within 360 degrees.

[0035] Optionally, the overlapping part has a smooth contact surface.

[0036] Optionally, the tube wall in the pre-shaped state is wound less than 720 degrees.

[0037] Optionally, the starting side and the ending side of the wall winding structure in the circumferential direction are connected by a flexible envelope film.

[0038] Optionally, a crease line is provided at the turning point of the flexible envelope film.

[0039] Optionally, the wall thickness of the flexible envelope film is 0.1 - 1 mm.

[0040] Optionally, the flexible envelope film is a circumferentially closed tubular structure, and the cross-sectional perimeter of the flexible envelope film tubular structure is greater than the wall length of the cross-section of the tube wall, and the tube wall is fixedly attached to the outer wall of the flexible envelope film.

[0041] Optionally, an elastic sleeve is wrapped around the outer periphery of the distal end of the tube wall.

[0042] Optionally, the distal end of the tube wall is connected to the sheath handle, and the connection part is wrapped by the elastic sleeve.

[0043] Optionally, the axial length of the elastic sleeve is 5 - 50 cm.

[0044] Optionally, a binding sleeve for limiting the tube wall in the pre-shaped state is wrapped outside the tube wall, and the binding sleeve bursts when the tube wall is in the expanded state.

[0045] Optionally, the binding sleeve axially extends beyond the proximal end of the tube wall, and the extended part is a closed-end structure.

[0046] Optionally, on the ending side of the wall winding structure in the circumferential direction, a chamfered corner structure is provided near the proximal end of the tube wall.

[0047] This application also provides an interventional device sealing method based on a hemostatic valve. The hemostatic valve includes a housing and a sealing film installed in the housing and having a tubular structure. The inner cavity of the tubular structure serves as an instrument channel and penetrates through the housing. A driving chamber capable of filling with fluid and a energy storage mechanism capable of being linked with the fluid are provided in the housing outside the sealing film. The interventional device sealing method includes:

[0048] Inject fluid into the driving chamber. The fluid drives the sealing film to close the instrument channel, and the fluid also acts on the energy storage mechanism to pre-store energy in the energy storage mechanism to maintain the state of the sealing film;

[0049] When an interventional device is inserted into the device channel, the sealing film is deformed by the extrusion of the interventional device and the energy storage mechanism is energized by the fluid;

[0050] When the interventional device is withdrawn from the device channel, the energy storage mechanism releases energy, and the sealing film is deformed by the fluid to close the device channel.

[0051] Optionally, each interventional device sealing method of the present application can be implemented based on the hemostatic valve in the above technical solution.

[0052] Optionally, the drive chamber is also connected to a fluid pipeline and is connected to an external fluid source through the fluid pipeline.

[0053] Optionally, a control valve is arranged on the fluid pipeline.

[0054] Optionally, the drive chamber is also connected to a balance chamber, and the fluid in the drive chamber is linked with the energy storage mechanism through the balance chamber; the connection mode of the fluid pipeline and the drive chamber is at least one of the following modes:

[0055] Directly connected to the drive chamber; or

[0056] Directly connected to the balance chamber; or

[0057] Directly connected between the drive chamber and the balance chamber.

[0058] Optionally, the external fluid source is provided by a pressure regulating structure.

[0059] Optionally, the driving mode of the pressure regulating structure is manual, electric or pneumatic.

[0060] Optionally, the pressure regulating structure has at least one storage chamber, and the fluid pipeline is communicated with the storage chamber.

[0061] Optionally, a cylindrical space is formed in the shell, and the energy storage mechanism includes:

[0062] A piston, slidably arranged in the cylindrical space, and separating the cylindrical space into the balance chamber and the energy storage chamber;

[0063] An energy storage element, located in the energy storage chamber, and the energy storage element is a gas and / or an elastic member that interacts with the piston. Specific beneficial technical effects will be further explained in the specific implementation manner in combination with specific structures or steps. Description of the Drawings

[0064] Figures 1a to 1b It is a schematic structural diagram of a multi-chamber hemostatic valve in an embodiment;

[0065] Figure 1cSchematic diagram of the initial state of the hemostatic valve in an embodiment;

[0066] Figure 1d It is Figure 1c Schematic diagram of the housing of the hemostatic valve in;

[0067] Figure 1e It is Figure 1c Schematic diagram of the working state of the hemostatic valve in;

[0068] Figure 1f For the instrument to enter Figure 1e Schematic diagram of the hemostatic valve in;

[0069] Figure 2a Schematic diagram of the initial state of the hemostatic valve in another embodiment;

[0070] Figure 2b It is Figure 2a Schematic diagram of the working state of the hemostatic valve in;

[0071] Figure 2c For the instrument to enter Figure 2b Schematic diagram of the hemostatic valve in;

[0072] Figure 2d It is Figure 2a Schematic diagram of the initial state of another implementation of the hemostatic valve in;

[0073] Figure 2e It is Figure 2d Schematic diagram of the working state of the hemostatic valve in;

[0074] Figure 2f For the instrument to enter Figure 2e Schematic diagram of the hemostatic valve in;

[0075] Figure 3 Schematic diagram of the adjusting part mechanism;

[0076] Figure 4a Schematic diagram of the initial state of the hemostatic valve in yet another embodiment;

[0077] Figure 4b It is Figure 4a Schematic diagram of the working state of the hemostatic valve in;

[0078] Figure 4c For the instrument to enter Figure 4b Schematic diagram of the hemostatic valve in;

[0079] Figure 5a It is Figure 4a Schematic diagram of the working state of another implementation of the hemostatic valve in;

[0080] Figure 5b For the instrument to enter Figure 5a Schematic diagram of the hemostatic valve in;

[0081] Figure 5c is Figure 4a a schematic diagram of the working state of another embodiment of the hemostatic valve;

[0082] Figure 6a and Figure 6b is a schematic diagram of the cooperation relationship between the tube body of the catheter sheath and the hemostatic valve in an embodiment;

[0083] Figures 7a to 10d is a schematic diagram of the structure of the multi-chamber hemostatic valve in other embodiments.

[0084] Figures 11a to 12f is a schematic diagram of the sheath tube in an embodiment.

[0085] The description of the reference numerals in the figure is as follows:

[0086] 1. Housing; 11. Instrument channel; 12. Driving chamber; 13. Penetration area; 14. First end cap; 15. Second end cap; 16. Exhaust hole;

[0087] 2. Sealing film; 21. Inner cavity;

[0088] 3. Energy storage mechanism; 31. Balance chamber; 311. Balance hole; 32. First pressure regulating hole; 33. Energy storage chamber; 331. Second pressure regulating hole; 332. Third end cap; 34. Piston; 341. Elastic member; 342. Adjusting member; 343. Adjusting operation part; 35. Elastic capsule; 351. Third pressure regulating hole;

[0089] 9. Interventional instrument; 91. Tube body;

[0090] 204. Tube wall; 205. Connector; 206. Elastic sleeve; 207. End side boundary; 208. Compressed part; 209. Starting side; 210. End side; 211. Extended part; 212. Non-extended part; 213. Overlapping area; 214. Flexible envelope film; 215. Meandering part; 216. Turning point; 217. Turning point. Detailed implementation manners

[0091] 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.

[0092] 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 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.

[0093] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill 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.

[0094] Reference Figure 1a and Figure 1b , this application also discloses a multi-chamber hemostatic valve, which includes 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. Along the radial direction of the instrument channel 11, a driving chamber 12 for filling fluid is provided in the housing 1 outside the sealing film 2, and a balance chamber 31 is located outside the driving chamber 12. The driving chamber 12 and the balance chamber 31 communicate with each other, and the balance chamber 31 surrounds the outer periphery of the driving chamber 12;

[0095] The hemostatic valve further includes an energy storage mechanism 3 that can be linked with the fluid. The fluid in the driving chamber 12 is linked with the energy storage mechanism 3 through the balance chamber 31; the energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing film 2 changes, and drives the sealing film 2 to seal the instrument channel 11 when releasing energy.

[0096] The balance chamber 31 surrounding the outer periphery of the driving chamber 12 can provide fluid for driving the movement of the sealing film 2 to the driving chamber 12 from multiple directions, so as to close the instrument channel 11. The power of the fluid in the balance chamber 31 is provided by the energy storage mechanism 3. Therefore, during the assembly process, energy can be pre-input to the energy storage mechanism 3 to improve the adaptability of the hemostatic valve to intervention instruments 9 with different outer diameters.

[0097] From the perspective of the driving unit of a single sealing film 2, there are various deformations. Reference Figure 1a Figures 1c to 5c , this application discloses a hemostatic valve, which includes 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 outside the sealing film 2. The 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, and drives the sealing film 2 to seal the instrument channel 11 when releasing energy.

[0098] 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 intervention instrument 9 to pass through. Therefore, the sealing of the sealing film 2 means that the volume of the cavity of the driving chamber 12 expands to squeeze the instrument channel to achieve sealing, such as Figure 1e is in a sealed state.

[0099] The sealing film 2 itself is a tubular structure, and the inner cavity 21 serves as the instrument channel 11. In order to ensure that the intervention instrument 9 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 that the inner cavity 21 of the sealing film 2 constitutes 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.

[0100] In terms of the interaction relationship, the driving chamber 12 can drive the sealing film 2 to change its own state, thereby realizing the closing or opening of the instrument channel 11. The instrument channel 11 is the channel for the intervention instrument 9 (such as a catheter, a guide wire, etc.) to enter and exit the human body during the intervention treatment process. Therefore, it can be understood that the area surrounded by the tubular structure is at least a 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, which can also be regarded as the instrument channel 11 penetrating 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 have a radially converging tendency, thereby reducing the cavity diameter of the instrument channel 11 until the instrument channel 11 is closed. Whether the intervention instrument 9 is in or not in the instrument channel 11, the sealing film 2 can achieve the closing or opening of the instrument channel 11. When the intervention instrument 9 is in the instrument channel 11, the inner cavity 21 of the sealing film 2 radially converges to cooperate with the intervention instrument 9 to achieve the closing of the instrument channel 11; when the intervention instrument 9 is not in the instrument channel 11, the inner cavity 21 of the sealing film 2 radially converges until it abuts and closes itself to achieve the closing of the instrument channel 11.

[0101] Analyzed from the principle, the fluid-driven sealing film 2 is mainly realized 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 sealing 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 an external pressure source, changing the fluid temperature, changing the physical properties of the fluid, and so on. The energy storage mechanism 3 in this embodiment can adaptively adjust the pressure state of the fluid. When the state of the sealing film 2 changes, the energy storage mechanism 3 can store or release energy accordingly, and use the stored energy to drive the sealing film 2 to seal the instrument channel 11. Compared with the design form of an external energy source, the technical solution of this embodiment can effectively improve the integration degree of the hemostatic valve, improve the degree and effect of the sealing film 2 changing its form, thereby providing a structural basis for the instrument channel 11 with a larger lumen diameter and interventional instruments 9 with different appearance sizes.

[0102] The tubular structure of the sealing film 2 mentioned in this application is not limited to a strictly circular tube in a strict sense. In actual products, the inner diameter of the inner cavity of the sealing film 2 may change 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 changing edges such as an hourglass shape, a pear shape, a spherical shape, or may be an irregularly changing shape.

[0103] In one 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.

[0104] The direct energy of the sealing film 2 comes from the driving chamber 12. In one embodiment, the hemostatic valve has a working state in which the driving chamber 12 is filled with fluid (for example Figure 1e ), and an initial state in which it is not filled with fluid (for example Figure 1c ), and the fluid is an incompressible liquid.

[0105] In the initial state, the air in the drive chamber 12 should be at normal pressure; in some products used in special scenarios, the drive chamber 12 can be set to a vacuum in the initial state. In this embodiment, the incompressibility of the liquid refers to that relative to the gas, not in the absolute sense. The incompressible characteristic of the liquid enables operators such as medical staff to accurately control the deformation degree of the sealing film 2. Specifically, in one embodiment, the fluid is physiological saline or water. The advantage of physiological saline or water as the fluid mentioned above is that it is convenient to obtain in the medical field. More importantly, even in the event of an accident, if the sealing function of the sealing film 2 fails, the fluid will not affect the intervention site, ensuring safety.

[0106] During the working process of the sealing film 2, the energy storage mechanism 3 can improve the working performance of the sealing film 2. Specifically, in one embodiment, the sealing film 2 has a first state in which it is squeezed by the intervention instrument 9 to open the instrument channel 11 (for example Figure 1f ), and the energy storage mechanism 3 is driven by the fluid to store energy; it is easy to understand that when the energy storage mechanism 3 is in the energy storage state, the fluid has a relatively high pressure to ensure the closed state of the instrument channel 11; that is, the energy storage mechanism 3 in the energy storage state still drives the sealing film 2 to seal the instrument channel 11.

[0107] The sealing film 2 has a second state in which it is driven by the fluid to close the instrument channel 11 (for example Figure 1e ), and the energy storage mechanism 3 releases energy to maintain the fluid pressure that keeps the sealing film 2 in the second state.

[0108] In the actual use process, for different working conditions of whether there is an intervention instrument 9 in the instrument channel 11, there are contradictions in the selection of the preset pressure of the fluid in the drive chamber 12. For example, in the technical solution without the energy storage mechanism 3:

[0109] When the intervention instrument 9 enters the hemostatic valve, the sealing film 2 needs to open the instrument channel 11 to avoid interfering with the intervention instrument 9. Therefore, the sealing film 2 does work on the fluid in the drive chamber 12. If the preset pressure of the fluid in the drive chamber 12 is too high, the driving force required for the deformation of the sealing film 2 will be too high, and the intervention 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 drive 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.

[0110] The energy storage mechanism 3 in this embodiment can well overcome the above problems. When the interventional device 9 enters the hemostatic valve, the sealing membrane 2 needs to open the device channel 11 to avoid interfering with the interventional device 9. At this time, the sealing membrane 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 device 9 and provide a good feel for the entry process of the interventional device 9; when the interventional device 9 exits the hemostatic valve, the sealing membrane 2 needs to close the device channel 11 to function as a hemostatic valve. At this time, the fluid in the driving chamber 12 does work on the sealing membrane 2, and at the same time, the energy storage mechanism 3 releases energy to do work on the fluid, ensuring the closing effect of the sealing membrane 2 on the device channel 11.

[0111] In the process of the change of the sealing membrane 2, it is actually a process of mutual work between the fluid and the sealing membrane 2. To ensure the effectiveness of the work, in one embodiment, the housing 1 is at least a rigid structure on the outer periphery of the driving chamber 12.

[0112] The housing 1 can limit the work done by the driving chamber 12 in other directions, so as to ensure that the energy of the fluid acts on the sealing membrane 2. Under the condition of a certain amount of energy, the stroke of the deformation of the sealing membrane 2 and the closing effect are improved. The rigidity mentioned in this embodiment is relative to the flexible sealing membrane 2 that can be deformed, rather than the rigidity of a rigid body in the physical concept. In actual products, the housing 1 may be made of materials such as plastics, 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 metals and plastics, or may be organic materials or inorganic materials; it may also be synthetic materials or natural materials, etc.

[0113] In the overall design of the housing 1, in one embodiment, the housing 1 is a rigid structure as a whole.

[0114] The fluid will generate a force on the surrounding components. Therefore, in the case of a relatively high fluid pressure, it may cause deformation of the housing 1. In the technical solution where the housing 1 is not rigid as a whole, the housing 1 may deform to consume the energy of the fluid, affecting the working effect of the sealing membrane 2. The technical solution in this embodiment can overcome this problem.

[0115] To facilitate observing the state of the sealing membrane 2, in one embodiment, the housing 1 is made of a transparent material.

[0116] In terms of principle, transparent materials are relative to materials through which the interior cannot be observed. Therefore, as long as the design that can observe the internal structure can meet the usage requirements in this embodiment, it should also be considered as the type of transparent expression in this embodiment, such as semi-transparent materials, etc. Correspondingly, in some special embodiments, transparency may be partial. For example, an observation window or the like is provided at the part where the internal structure needs to be observed to achieve this. In the mating relationship between the housing 1 and the sealing film 2, in one embodiment, a through area 13 is provided in the housing 1, the sealing film 2 is arranged in the through area 13, and a driving chamber 12 is formed between the outer periphery of the sealing film 2 and the inner wall of the corresponding through area 13.

[0117] The through area 13 houses the sealing film 2, preventing the external environment from affecting the inside of the through area 13 from directions other than the instrument channel 11, and can improve the working stability of the sealing film 2. At the same time, the through area 13 also participates in forming the driving chamber 12, improving the component integration of the hemostatic valve, facilitating the control of the overall volume of the hemostatic valve, and being convenient for use during the treatment process.

[0118] In one embodiment, first end caps 14 and second end caps 15 are respectively and sealingly installed at the two open ends of the through area 13. Avoidance holes corresponding to the instrument channel 11 are provided on each end cap, and the axial two ends of the sealing film 2 are clamped and fixed between the housing 1 and the corresponding side end cap.

[0119] The first end cap 14 and the second end cap 15 can fix the sealing film 2, thereby guiding the working direction of the sealing film 2. The avoidance holes can also play a guiding role during the working process, ensuring the contact position between the interventional instrument 9 and the sealing film 2 when the interventional instrument 9 enters the instrument channel 11, and reducing the possibility of damage to the sealing film 2 caused by the interventional instrument 9.

[0120] In one embodiment, one end of the instrument channel 11 is the inlet of the interventional instrument 9, and the other end is the outlet of the interventional instrument 9. A radially through exhaust hole 16 is provided on the end cap on the side of the outlet of the interventional instrument 9.

[0121] When medical devices such as catheters entering the body are in use, it is usually necessary to expel the gas inside the instrument. The exhaust hole 16 can overcome the problem of the gas carried by the instrument before use. At the same time, the operator can inject normal saline into the exhaust hole 16 to remove the gas inside the hemostatic valve before use. Further, the exhaust hole 16 itself is also an interface, providing a structural basis for special operations in special usage scenarios.

[0122] In the setting of the exhaust hole 16, in one embodiment, the exhaust hole 16 is communicated with an exhaust valve (not shown in the figure);

[0123] The exhaust valve is directly installed on the exhaust hole 16 or communicated with the exhaust hole 16 through an external pipeline.

[0124] The flexible setting of the exhaust valve can be adjusted according to the use needs of different cases. For example, the design of the exhaust valve being directly installed on the exhaust hole 16 can improve the integration of the hemostatic valve and facilitate the operation of medical personnel and other operators; for another example, the design of the exhaust valve being connected to the exhaust hole 16 through an external pipeline can further reduce the external size of the hemostatic valve and provide adaptability.

[0125] In terms of the assembly relationship of the components, in one embodiment, each end cover is fixed to the housing 1 by means of screws (not shown).

[0126] The end cap needs to form a relatively closed space in the housing 1, and in some embodiments, the sealing film 2 needs to be fixed, so the installation stability of the end cap is related to the working stability of the hemostatic valve. The end cap itself can also be installed through its own structure. In order to improve the convenience of installation, screws are a reasonable choice.

[0127] In the design of the energy storage mechanism 3 , in one embodiment, a balancing chamber 31 is further provided in the housing 1 , the driving chamber 12 and the balancing chamber 31 are interconnected, and the fluid in the driving chamber 12 is linked to the energy storage mechanism 3 via the balancing chamber 31 .

[0128] The function of the balancing chamber 31 is to constrain the movement of the energy storage mechanism 3. In a special embodiment, the balancing chamber 31 may also be connected to the driving chamber 12 over a large area. Therefore, the concept of the balancing chamber 31 needs to be understood from the principle of the energy storage mechanism 3, rather than a space that is relatively isolated from the driving chamber 12 in structure. For example, in one embodiment, the balancing chamber 31 is openly connected to the driving chamber 12 (not shown).

[0129] In terms of the design details of the balance chamber 31, in one embodiment, along the radial direction of the instrument channel 11, the balance chamber 31 is located outside the drive chamber 12, such as Figure 8a shown.

[0130] The driving chamber 12 is a component that directly drives the sealing membrane 2 to work, and it is a reasonable design to be close to the sealing membrane 2. The design of the balancing chamber 31 on the radial outer side of the driving chamber 12 along the instrument channel 11 can reduce the axial length of the hemostatic valve in the instrument channel 11, which is convenient for operation during treatment.

[0131] In one embodiment, the balancing chamber 31 surrounds the outer circumference of the driving chamber 12 .

[0132] When the interventional instrument 9 enters the instrument channel 11, the fluid will be squeezed by the sealing membrane 2 and diffused radially. The balance chamber 31 is designed on the periphery to be able to bear the diffusion trend of the fluid and has a good dynamic response.

[0133] The balancing chamber 31 has the function of constraining the energy storage mechanism 3. In one embodiment, the driving chamber 12 and the balancing chamber 31 are isolated from each other and are only connected through the balancing hole 311.

[0134] The balance hole 311 is used for fluid to pass through, so as to realize the energy storage or energy release of the fluid in the driving chamber 12 by the energy storage mechanism 3. The design of isolating the driving chamber 12 from the balance chamber 31 can prevent the fluid in the driving chamber 12 from affecting the operation of the energy storage mechanism 3, thereby improving the working stability of the energy storage mechanism 3.

[0135] In the setting of the balance hole 311, in one embodiment, one end of the instrument channel 11 is the entrance of the interventional instrument 9, and the other end is the exit of the interventional instrument 9, and the balance hole 311 is adjacent to the exit of the interventional instrument 9.

[0136] The instrument channel 11 is the channel for the interventional instrument 9 to enter the hemostatic valve. During the process of the interventional instrument 9 entering the hemostatic valve, there may be a process in which the interventional instrument 9 first contacts a part of the sealing film 2. Correspondingly, the fluid in the driving chamber 12 will also be gradually affected by the interventional instrument 9. The balance hole 311 is arranged at a position adjacent to the exit of the interventional instrument 9, which can adapt to the process of the interventional instrument 9 entering the hemostatic valve, and better reflect the dynamic change of the fluid into the balance chamber 31 through the balance hole 311.

[0137] In the further optimization of the pressure regulation of the fluid, in one embodiment, a first pressure regulation hole 32 is formed in the chamber wall of the balance chamber 31 or the driving chamber 12.

[0138] The first pressure regulation hole 32 can realize the external pressure regulation of the fluid in the driving chamber 12. In some use scenarios, an external pressure source can be set to regulate the pressure of the fluid in the driving chamber 12. At the same time, the first pressure regulation hole 32 itself is also an interface, which can provide a structural basis for special operations in special use scenarios, such as serving as an exhaust channel.

[0139] In one embodiment, the first pressure regulation hole 32 is communicated with a first regulating valve (not shown in the figure);

[0140] The first regulating valve is directly installed on the first pressure regulation hole 32 or communicated with the first pressure regulation hole 32 through an external pipeline.

[0141] The flexible setting of the first regulating valve can be adjusted according to the usage requirements of different cases. For example, the design of directly installing the first regulating valve on the first pressure regulation hole 32 can improve the integration degree of the hemostatic valve and facilitate the operation of operators such as medical staff; for another example, the design of communicating the first regulating valve with the first pressure regulation hole 32 through an external pipeline can further reduce the external size of the hemostatic valve and provide adaptability.

[0142] In the further optimization of the energy storage mechanism 3, the energy storage mechanism 3 includes an energy storage chamber 33 and an energy storage element installed in the energy storage chamber 33. The energy storage element stores or releases energy correspondingly when the state of the sealing film 2 changes, and drives the sealing film 2 to seal the instrument channel 11 when releasing energy.

[0143] Specifically, in one embodiment, the energy storage mechanism 3 includes:

[0144] An energy storage chamber 33; a balance chamber 31 is further provided in the housing 1, and the driving chamber 12 communicates with the balance chamber 31;

[0145] A piston 34, which is hermetically slidable between the balance chamber 31 and the energy storage chamber 33;

[0146] An energy storage element, which is a compressible gas and / or an elastic member located in the energy storage chamber 33 and acting on the piston 34.

[0147] In this embodiment, the change in the position of the piston 34 realizes the energy storage or energy release of the energy storage mechanism 3. During the energy storage process, energy is absorbed by the compressible gas and / or the elastic member 341. During the energy release process, the compressible gas and / or the elastic member 341 does work to realize energy release. The energy storage chamber 33 is a functional expression of the energy storage mechanism 3 during the energy storage process. During the energy release process, the energy storage element is in the energy storage chamber 33, and its actual function is energy release.

[0148] The piston 34 is hermetically slidable between the balance chamber 31 and the energy storage chamber 33. In fact, the piston 34 itself is the dividing line between the balance chamber 31 and the energy storage chamber 33. Therefore, the relative space between the balance chamber 31 and the energy storage chamber 33 changes. When the energy storage mechanism 3 releases energy, the piston 34 moves towards the balance chamber 31, and part of the balance chamber 31 becomes the energy storage chamber 33; when the energy storage mechanism 3 stores energy, the piston 34 moves towards the energy storage chamber 33, and part of the energy storage chamber becomes the balance chamber 31. The sealed fit of the piston 34 is actually to prevent the fluid in the balance chamber 31 (i.e., the fluid in the driving chamber 12) from entering the energy storage chamber 33. This design is very important when the hemostatic valve is not connected to an external pressure source. During some treatment processes, the energy storage mechanism 3 may need to be adjusted accordingly. In one embodiment, a second pressure regulating hole 331 is provided on the chamber wall of the energy storage chamber 33.

[0149] The second pressure regulating hole 331 can adjust the change in the energy storage amount of the energy storage mechanism 3, so as to perform fine adjustment according to different treatment processes and improve the adaptability of the hemostatic valve. At the same time, the second pressure regulating hole 331 itself is also an interface, which can provide a structural basis for special operations in special usage scenarios.

[0150] In one embodiment, one end of the instrument channel 11 is the entrance of the interventional instrument 9, and the other end is the exit of the interventional instrument 9. Along the axial direction of the instrument channel 11, the balance chamber 31 is adjacent to the exit of the interventional instrument 9, and the energy storage chamber 33 is adjacent to the entrance of the interventional instrument 9.

[0151] The instrument channel 11 is the channel through which the interventional instrument 9 enters the hemostatic valve. During the process of the interventional instrument 9 entering the hemostatic valve, there may be a process in which the interventional instrument 9 first contacts a part of the sealing film 2. Correspondingly, the fluid in the driving chamber 12 will also be gradually affected by the interventional instrument 9. The balance chamber 31 is a structure directly communicating with the driving chamber 12. Therefore, the balance chamber 31 is arranged at a position adjacent to the outlet of the interventional instrument 9 to adapt to the process of the interventional instrument 9 entering the hemostatic valve, and better reflect the dynamic change of the fluid to the energy storage mechanism 3 through the balance chamber 31.

[0152] In one embodiment, the energy storage chamber 33 is an open structure on the side facing away from the balance chamber 31 and is hermetically installed with a third end cap 332. The second pressure regulating hole 331 is arranged on the third end cap 332.

[0153] The third end cap 332 actually constitutes the side wall of the energy storage chamber 33, so it is the key to maintaining the pressure in the energy storage chamber 33 during hermetic installation. At the same time, the second pressure regulating hole 331 is arranged on the third end cap 332, which can avoid opening holes in the energy storage chamber 33, reduce the process difficulty and avoid the possibility of leakage.

[0154] In terms of the setting details of the second pressure regulating hole 331, in one embodiment, the second pressure regulating hole 331 is communicated with a second regulating valve (not shown in the figure);

[0155] The second regulating valve is directly installed on the second pressure regulating hole 331 or communicated with the second pressure regulating hole 331 through an external pipeline.

[0156] The flexible setting of the second regulating valve can be adjusted according to the usage needs of different cases. For example, the design that the second regulating valve is directly installed on the second pressure regulating hole 331 can improve the integration degree of the hemostatic valve and facilitate the operation of operators such as medical staff; for another example, the design that the second regulating valve is communicated with the second pressure regulating hole 331 through an external pipeline can further reduce the external dimensions of the hemostatic valve and provide adaptability.

[0157] In terms of the detailed structure of the energy storage chamber 33, in one embodiment, an adjusting member 342 is arranged in the energy storage chamber 33 and abuts against the elastic member 341. At least a part of the adjusting member 342 is exposed in the energy storage chamber 33 as an adjusting operation part 343.

[0158] The function of the adjusting member 342 is to adjust parameters such as the preload and rebound speed of the elastic member 341, so as to facilitate the operator of medical staff to finely adjust the parameters of the hemostatic valve to adapt to different treatment processes. The adjusting operation part 343 is exposed in the energy storage chamber 33 for convenient operation, avoiding the disassembly of the hemostatic valve, and enabling fine adjustment during the treatment process. In the design scheme without the elastic member 341, the second pressure regulating hole 331 communicated with the energy storage chamber 33 can also be regarded as a deformation of the adjusting member 342.

[0159] In the assembly of the adjusting member 342, in one embodiment, the energy storage chamber 33 is of an open structure on the side facing away from the balance chamber 31 and is hermetically installed with a third end cover 332, and the adjusting member 342 is arranged on the third end cover 332.

[0160] The third end cover 332 is fixed to the housing 1, has good strength, and can facilitate adjustment and assembly while withstanding the load of the elastic member 341.

[0161] In the specific component structure of the adjusting member 342, in one embodiment, the adjusting member 342 is an adjusting screw rod that is in threaded fit with the chamber wall of the energy storage chamber 33. The head of the adjusting screw rod serves as the adjusting operation portion 343, and one end of the adjusting screw rod opposite to the head abuts against the elastic member 341.

[0162] The form of the adjusting screw rod is simple and reliable. Most importantly, the adjustment accuracy is relatively high, which is convenient for operators such as medical staff to finely adjust the working parameters of the hemostatic valve. At the same time, the threaded fit can conveniently achieve a sealing fit on the premise of realizing the adjustment.

[0163] In the detailed setting of the piston 34, in one embodiment, the moving direction of the piston 34 is parallel to or at an included angle with the extending direction of the instrument channel 11.

[0164] The function of the piston 34 is to deliver the pressure of the fluid to the energy storage mechanism 3. The setting of the moving direction does not affect the realization of the function of the piston 34. More considerations are given to the overall layout structure of the hemostatic valve. In actual products, it may be set as required. For example, the design in which the moving direction of the piston 34 is parallel to the extending direction of the instrument channel 11 can obtain a more regular overall shape; for another example, the design in which the moving direction of the piston 34 is at an included angle with the extending direction of the instrument channel 11 can achieve a more compact and practical overall shape in some products with special needs.

[0165] The energy storage mechanism 3 can also achieve the working effect through other structures. In one embodiment, the energy storage element is an elastic bladder placed inside or outside the energy storage chamber. In the drawings, the function of the energy storage chamber is actually replaced by the balance chamber 31. The elastic bladder 35 can cooperate to store or release energy, thereby further increasing the energy storage amount or energy release amount of the energy storage skill.

[0166] Specifically, in one embodiment, the elastic bladder 35 is suspended in the balance chamber 31 or fixed to the chamber wall of the balance chamber 31.

[0167] The energy storage and release of the elastic bladder 35 are achieved through its own deformation. Therefore, there are various fixing methods.

[0168] For example, refer to Figure 5c, the elastic bladder 35 is suspended in the balance chamber 31, and multiple ones can be designed. This design can fully release the deformation of the elastic bladder 35, and the position change of the elastic bladder 35 can also provide a structural basis for additional functions in some special scenarios. For example, it can indicate the density change of the fluid in the balance chamber 31, etc. Here, suspension is relative to fixation. Specifically, the position of the elastic bladder 35 in the energy storage chamber 33 needs to be determined according to the density of the medium stored in the elastic bladder 35 and the density of the medium in the energy storage chamber 33.

[0169] For another example, referring to Figures 4a to 5b , the elastic bladder 35 is fixed to the chamber wall of the balance chamber 31. This design can determine the position of the elastic bladder 35 and prevent the elastic bladder 35 and the balance chamber 31 from rubbing against each other during storage, transportation or use, thus avoiding damage to the elastic bladder 35.

[0170] Referring to Figures 4a to 4c , in one embodiment, the elastic bladder 35 is fixed to the chamber wall of the balance chamber 31, and a third pressure regulating hole 351 communicating with the elastic bladder 35 is provided on the chamber wall of the balance chamber 31.

[0171] The third pressure regulating hole 351 can realize the external pressure regulation of the elastic bladder 35. In some usage scenarios, an external pressure source can be set to regulate the pressure of the fluid in the elastic bladder 35. At the same time, the third pressure regulating hole 351 itself is also an interface, which can provide a structural basis for special operations in special usage scenarios.

[0172] In one embodiment, the third pressure regulating hole 351 is communicated with a third regulating valve (not shown in the figure);

[0173] The third regulating valve is directly installed on the third pressure regulating hole 351 or is communicated with the third pressure regulating hole 351 through an external pipeline.

[0174] The flexible setting of the third regulating valve can be adjusted according to the usage requirements of different cases. For example, the design of directly installing the third regulating valve on the third pressure regulating hole 351 can improve the integration of the hemostatic valve and facilitate the operation of operators such as medical staff; for another example, the design of communicating the third regulating valve with the third pressure regulating hole 351 through an external pipeline can further reduce the external size of the hemostatic valve and provide adaptability.

[0175] In the specific structure of the elastic bladder 35, in one embodiment, the elastic bladder 35 is a hollow structure and is filled with gas, and energy is stored or released through the gas.

[0176] The advantage of gas compared with other elastic design forms is that the deformation amount is larger, which is convenient for better energy storage or release. The elastic bladder 35 can confine the gas and reduce the risk of affecting the interventional operation.

[0177] Correspondingly, in one embodiment, the elastic bladder 35 is made of an elastic material, and stores or releases energy through the deformation of the elastic material.

[0178] The elastic bladder 35 itself is made of an elastic material, which can avoid the influence that gas may have on the intervention operation and provide a safer guarantee for the intervention operation. More importantly, through the elasticity of the elastic bladder itself, technical effects different from other solutions can be achieved. For example, as an embodiment of the present invention, a release hole is opened on the housing, and an elastic bladder is covered on the release hole. The fluid enters the elastic bladder under the extrusion of the sealing film and drives the elastic bladder to deform and store energy; in the energy release stage, the elastic bladder deforms itself to squeeze the internal fluid back into the housing, thereby realizing energy release.

[0179] As exemplified above, in some cases, the energy storage element disposed in the energy storage chamber 33 may be deformed. Therefore, the following several exemplary embodiments should be understood as equivalent solutions of the present application.

[0180] A release hole is opened on the housing, and an elastic member is covered on the release hole. The fluid enters the elastic bladder under the extrusion of the sealing film and drives the elastic bladder to deform and store energy, similar to the state of blowing a balloon in life. At this time, the elastic member expands the volume of the energy storage chamber; in the energy release stage, the elastic bladder deforms itself to squeeze the internal fluid back into the housing, thereby realizing energy release. The energy storage element in this solution is located on the boundary of the energy storage chamber 33. It can be understood that during the energy storage process of the energy storage element, the energy storage element expands itself and enlarges the energy storage chamber.

[0181] The energy storage element is a tension spring, which is disposed at the position labeled as the balance chamber in the drawing. The fluid enters the energy storage chamber under the extrusion of the sealing film and drives the tension spring to stretch and store energy. At this time, the balance chamber actually constitutes the concept of the energy storage chamber. The judgment of the concept of the energy storage chamber should be based on the actual function. In some solutions, the energy storage chamber may share with the balance chamber.

[0182] Reference Figure 6a and Figure 6b , the present application also discloses a catheter sheath, which includes a tube body 91 and a hemostatic valve that are connected and communicated with each other. The hemostatic valve is based on the above technical solution.

[0183] The tube body 91 intervenes into the human body. The hemostatic valve closes the tube body. The interventional device 9 enters the tube body 91 through the hemostatic valve and then enters the human body to implement the treatment process.

[0184] In one embodiment, the hemostatic valve is provided with a tube joint connected to the tube body 91. The tube joint is matched with the tube body 91 through a sealing member, and the tube joint is provided with a clamping structure to prevent the separation of the tube body 91 and the tube joint. In this embodiment, the tube 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 an emergency can also be realized.

[0185] In terms of specific detailed operations, the head of the tube body 91 is provided with a developing point, which facilitates medical staff to better complete the surgical process with the help of medical equipment.

[0186] During the use of the hemostatic valve, the butt-connected tube body and the hemostatic valve cooperate to form an instrument channel 11, where the tube body can be integrally or separately arranged with the end caps on both sides. Each end cap extends away from the hemostatic valve, thereby extending axially along the instrument channel 11 to further wrap and protect the instrument channel 11 for the intervention instrument 9 to pass through.

[0187] Reference Figures 7a to 11b Furthermore, the present application also discloses a multi-chamber hemostatic valve, which includes 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 the instrument channel 11. Along the radial direction of the instrument channel 11, a driving chamber 12 for filling fluid is provided in the housing 1 outside the sealing film 2, and a balance chamber 31 is located outside the driving chamber 12. The driving chamber 12 and the balance chamber 31 communicate with each other, and the balance chamber 31 surrounds the outer periphery of the driving chamber 12.

[0188] The hemostatic valve further includes an energy storage mechanism 3 that can be linked with the fluid. The fluid in the driving chamber 12 is linked with the energy storage mechanism 3 through the balance chamber 31. The energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing film 2 changes, and drives the sealing film 2 to seal the instrument channel 11 when releasing energy.

[0189] The balance chamber 31 surrounding the outer periphery of the driving chamber 12 can provide fluid for driving the movement of the sealing film 2 from multiple directions, so as to realize the closing of the instrument channel 11. In terms of the actual surrounding form, there are various implementation methods. For example, in one embodiment, there are multiple balance chambers 31 and they are arranged at intervals on the outer periphery of the driving chamber 12, and an energy storage mechanism 3 is configured for each balance chamber 31 respectively; further, the balance chambers 31 are evenly or unevenly spaced on the outer periphery of the driving chamber 12. For another example, in one embodiment, each balance chamber 31 communicates with the driving chamber 12 through an independent balance hole 311, or at least two balance chambers 31 share the same balance hole 311 to communicate with the driving chamber 12. Further, each balance chamber 31 communicates with the driving chamber 12 through the same balance hole 311. For another example, in one embodiment, the number of balance chambers 31 is 2 to 8.

[0190] Different settings of the energy storage mechanism 3 and the combinations between various setting methods will also have an impact. For example, in one embodiment, the energy storage mechanism 3 includes: an energy storage chamber 33; a balance chamber 31 is further provided in the housing 1, and the driving chamber 12 is in communication with the balance chamber 31; a piston 34, which seals and slides between the balance chamber 31 and the energy storage chamber 33; an energy storage element, and the energy storage element is a compressible gas and / or an elastic member 341 located in the energy storage chamber 33 and acting on the piston 34; at least two cylindrical spaces for the piston 34 to slide are provided on the housing 1, and the cylindrical spaces are divided into a balance chamber 31 and an energy storage chamber 33 by the piston 34. For another example, in one embodiment, each piston 34 is in sealing cooperation with the inner wall of the corresponding cylindrical space through the sealing edge on its outer edge, and at least two seals are provided between the sealing edge and the inner wall of the cylindrical space in the sliding direction of the piston 34. For another example, in one embodiment, at least two cylindrical spaces for the piston 34 to slide are provided on the housing 1, and independent energy storage elements are provided in each cylindrical space, and the energy storage performances of the energy storage elements are the same or different.

[0191] For the specific combination forms and the resulting technical effects, reference can be made to several exemplary embodiments given below.

[0192] Reference Figures 7a to 7d 、 Figure 11a and Figure 11b In the embodiments of

[0193] From the perspective of the design principles of each component, an increase in the number of balance chambers 31 can provide a more uniform and delicate driving effect for the sealing film 2. However, if the number is too large, it will increase the processing difficulty of the housing 1; moreover, with the housing 1 of the same volume, the side walls between adjacent balance chambers 31 will become thinner, thus bringing corresponding potential hazards. Therefore, the number of balance chambers 31 is preferably 2 to 8. The uniform spacing of the balance chambers 31 around the outer periphery of the driving chamber 12 can bring a good visual effect and can also provide relatively stable acting forces in all directions of the instrument channel 11. Correspondingly, in some special cases, the balance chambers 31 can also be unevenly spaced around the outer periphery of the driving chamber 12 to provide uneven driving forces to achieve special effects. In this embodiment, each balance chamber 31 is respectively communicated with the driving chamber 12 through an independent balance hole 311. The advantage of this design is that it can avoid mutual interference during the working process of the balance chambers 31 and can provide a more delicate adjustment effect. Correspondingly, in some special cases, each balance chamber 31 can also share the balance hole 311 to communicate with the driving chamber 12. The advantage of this design is that it can synchronize the working processes of different balance chambers 31, and the specific design can be adjusted according to different working conditions and design requirements. In the setting of the energy storage mechanism 3, the piston 34 is the main work-performing component, and the energy storage element is an elastic member 341 in this embodiment, which respectively abuts against the piston 34 and the third end cover 332 at both ends to achieve energy storage and energy release. Therefore, the piston 34 needs to ensure good sealing with the inner wall of the cylindrical space to avoid pressure leakage of the fluid. In this embodiment, it is achieved through two sealing edges of the piston 34 itself. At the same time, in order to avoid the resistance caused by too large a sealing contact area, a sealing gap is provided between the sealing edges, and this sealing gap can also release the deformation of the sealing edges, thereby improving the sealing effect.

[0194] In a specific product, in addition to whether the balance chambers 31 are evenly arranged around the outer periphery of the driving chamber 12, different effects can also be achieved through different settings between different balance chambers 31. For example, in this embodiment, the diameter lengths of each cylindrical space are the same, and the elastic coefficients of the elastic members 341 are the same to obtain a more balanced fluid driving effect. In other embodiments, the diameter lengths of each cylindrical space can be different, and the elastic coefficients of the elastic members 341 can also be different, so as to be flexibly adjusted according to different working conditions and design requirements. Correspondingly, when the energy storage element is a compressible gas, the physical and chemical indexes of the compressible gas can also be adjusted. For example, parameters such as the preset working pressure and preset working temperature of the compressible gas can change accordingly.

[0195] During the assembly process of the product of this embodiment, it can be operated in the following manner: Inject a certain amount of liquid from the first pressure regulating hole 32 to make the piston 34 move slightly to the left and remain stable. At this time, the pressures in the balance chamber 31 and the energy storage chamber 33 are balanced, and the sealing film 2 is squeezed by the liquid in the driving chamber 12 and closely adheres to seal the instrument channel 11;

[0196] The gas on the side of the instrument channel 11 entering the body is exhausted through the exhaust hole 16, and then the instrument is inserted into the blood vessel. At this time, the blood vessel is communicated with the catheter sheath to form a window for the instrument to enter, and the blood is sealed in the body by the sealing film 2.

[0197] When the product of this embodiment is used in an interventional operation, the instrument enters the body from the middle of the sealing film 2 and is tightly wrapped by the sealing film 2. The blood is always blocked in the body by the sealing film 2. When the instrument passes through the channel, the pressure in the driving chamber 12 rises due to the decrease in volume, so that the piston 34 is pushed to move leftward by the liquid, and the elastic member 341 is compressed to store energy. The internal pressure reaches a new balance and can still be sealed. When the instrument exits, the elastic member 341 releases energy and pushes the piston 34 to move rightward to return to the initial state. During the entry and exit of the instrument, the sealing film 2 is always squeezed and continuously sealed.

[0198] Reference Figures 8a to 8d Furthermore, the present application also discloses a multi-chamber hemostatic valve, which includes 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 the instrument channel 11. Along the radial direction of the instrument channel 11, a driving chamber 12 for filling fluid is provided in the housing 1 outside the sealing film 2, and a balance chamber 31 is located outside the driving chamber 12. The driving chamber 12 and the balance chamber 31 are communicated with each other, and the balance chamber 31 surrounds the outer periphery of the driving chamber 12.

[0199] The hemostatic valve further includes an energy storage mechanism 3 that can be linked with the fluid. The fluid in the driving chamber 12 is linked with the energy storage mechanism 3 via the balance chamber 31. The energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing film 2 changes, and drives the sealing film 2 to seal the instrument channel 11 when releasing energy. The number of balance chambers 31 is preferably six. Without considering other factors such as the product volume and production process, theoretically, the more balance chambers 31 are set, the better. According to the volumes of the current product's driving chamber 12 and balance chamber 31, as well as considering function and cost from structural design, spring selection to mass production, the current optimal number of chambers is 5 - 6.

[0200] The main difference in this embodiment lies in the number of balance chambers 31. Six balance chambers 31 can achieve better instrument compatibility, and the resistance performance when the instrument passes through is better than that of the embodiment with fewer balance chambers 31.

[0201] In addition to the different settings of the balance chamber 31, the energy storage elements can also be correspondingly changed and adjusted. Reference Figures 9a to 9dThe present application also discloses a multi-chamber hemostatic valve, comprising a housing 1 and a sealing membrane 2 installed in the housing 1 and having a tubular structure, wherein an inner cavity 21 of the tubular structure serves as an instrument channel 11, and along the radial direction of the instrument channel 11, a driving chamber 12 for filling a fluid and a balancing chamber 31 located outside the driving chamber 12 are provided in the housing 1, wherein the driving chamber 12 and the balancing chamber 31 are connected to each other and the balancing chamber 31 surrounds the outer periphery of the driving chamber 12;

[0202] The hemostatic valve also includes an energy storage mechanism 3 that can be linked with the fluid. The fluid in the driving chamber 12 is linked with the energy storage mechanism 3 via the balance chamber 31. The energy storage mechanism 3 stores or releases energy accordingly when the state of the sealing membrane 2 changes, and when releasing energy, drives the sealing membrane 2 to seal the instrument channel 11. The energy storage element includes an elastic member 341 and a compressible gas.

[0203] The housing 1 is a solid body with multiple cylindrical spaces, an instrument channel 11 in the middle, and multiple pistons 34 are installed in the cylindrical spaces around the instrument channel 11 to form an energy storage chamber 33 and a balance chamber 31, wherein the balance chamber 31 is connected to the drive chamber 12, and each energy storage chamber 33 has a built-in spring, and the energy storage chamber 33 has a second pressure regulating hole 331, which is used to realize the function of injecting gas in this embodiment. The housing 1 is connected to the second end cover 15, and a seal is built in for sealing, wherein the second end cover 15 is provided with a first pressure regulating hole 32; the second end cover 15 and the first end cover 14 fix and seal the sealing membrane 2 on the housing 1. The exhaust hole 16 is connected to the blood and is used to exhaust the gas in the instrument channel 11.

[0204] Compared with the arrangement in which the energy storage element is a separate elastic member 341, this embodiment adds gas as a compressed medium to facilitate the adjustment of the resistance of instruments with different diameters, which is more flexible. However, correspondingly, it has higher requirements on the sealing of the energy storage chamber 33, the balance chamber 31 and the related components, and the process is relatively complicated.

[0205] It is not difficult to see from the accompanying drawings that in this embodiment, each balancing chamber 31 can actually be interconnected through the drive chamber 12, that is, the sealing membrane 2 is a whole, and the drive chamber 12 is arranged around the sealing membrane 2 and is connected to each balancing chamber 31. In other embodiments, the sealing membrane 2 may not be a whole, and a plurality of sealing membranes 2 are combined to achieve the closure of the instrument channel 11; in this implementation, the drive chambers 12 between different sealing membranes 2 may not be connected, and accordingly, the balancing chambers 31 between different drive chambers 12 are also not connected.

[0206] Similarly, the energy storage element can be further changed. Figures 10a to 10d, this application also discloses a multi - cavity hemostatic valve, which includes 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. Along the radial direction of the instrument channel 11, a driving chamber 12 for filling fluid is provided in the housing 1 outside the sealing film 2, and a balance chamber 31 is located outside the driving chamber 12. The driving chamber 12 and the balance chamber 31 communicate with each other, and the balance chamber 31 surrounds the outer periphery of the driving chamber 12;

[0207] The hemostatic valve further includes an energy storage mechanism 3 that can be linked with the fluid. The fluid in the driving chamber 12 is linked with the energy storage mechanism 3 via the balance chamber 31; the energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing film 2 changes, and drives the sealing film 2 to seal the instrument channel 11 when releasing energy. The energy storage element package is a compressible gas.

[0208] The product of this embodiment can be operated in the following manner during the assembly process:

[0209] First, inject a certain volume of gas through the second pressure adjustment hole 331. Then, inject a certain amount of liquid through the first pressure adjustment hole 32 to make the piston 34 move slightly to the left and remain stable. At this time, the pressure in the energy storage chamber 33 is balanced with that in the driving chamber 12, and the sealing film 2 is squeezed by the liquid in the driving chamber 12 and closely adheres, sealing the instrument channel 11.

[0210] The product of this embodiment can be operated in the following manner during use: Drain the gas on the side where the instrument channel 11 enters the body through the first pressure adjustment hole 32, and then insert it into the blood vessel. At this time, the blood vessel is connected to the catheter sheath to form an instrument channel 11 for the instrument to enter, and the blood is sealed in the body by the sealing film 2. When performing an interventional operation, the instrument enters the body from the middle of the sealing film 2 and is tightly wrapped by the sealing film 2. The blood is always blocked in the body by the sealing film 2. When the instrument passes through the channel, the volume of the driving chamber 12 becomes smaller and the pressure rises, thereby pushing the piston 34 to move to the left, and the compressible gas is compressed and stores energy, and the internal pressure reaches a new balance and can still be sealed. When the instrument exits, the compressible gas releases energy and pushes the piston 34 to move to the right, returning to the initial state. During the entry and exit of the instrument, the sealing film 2 is always squeezed and continuously sealed.

[0211] Compared with the setting method where the energy storage element is a combination of an elastic member 341 and a compressible gas, in this embodiment, when the pure compressible gas is used as the elastic medium, the resistance for different - diameter instruments to pass through further tends to be gentle; it is convenient to adjust the resistance for different - diameter instruments to pass through, which is more flexible. Correspondingly, the requirements for the sealing performance of the energy storage chamber 33, the balance chamber 31, and the related components are relatively high, and the process is relatively complex.

[0212] In view of the above embodiments, the multi-cavity structure composed of multiple balancing chambers 31 has the following advantages and design starting points compared with the single cavity structure of other embodiments:

[0213] 1. The structure is simple and reliable, the requirements for the elastic performance of the spring are low, and it is easy to mass produce;

[0214] 2. The multi-cavity structure is highly compatible with different instruments, and the resistance can be stabilized in a smaller range. It can be summarized that the resistance of instruments with different diameters is basically the same.

[0215] 3. The optimal number of cavities needs to be calculated based on the volume of the drive chamber 12 and the volume of the balance chamber 31. The largest instrument enters the instrument channel 11 so that the volume of liquid discharged by the drive chamber 12 causes the pistons 34 in multiple balance chambers 31 to move less than 5 mm at the same time. The smaller the movement stroke, the better.

[0216] The third end cover 332 mentioned above is used to close the energy storage chamber 33. In this embodiment, the provision of multiple balance chambers 31 will increase the number of third end covers 332, complicate the installation process, and cause unnecessary stability risks. Therefore, in this embodiment, the function of the third end cover 332 is realized by the first end cover 14.

[0217] In this embodiment, the second end cover 15 also has changes in details. In order to facilitate assembly and achieve compact fit between the various components, the second end cover 15 actually has two parts, which are respectively used to achieve fit with the shell 1 and installation of the sheath tube. The two parts are respectively provided with the first pressure regulating hole 32 and the exhaust hole 16 mentioned above.

[0218] From the overall product point of view, the hemostatic valve also includes a pressure regulating structure for conveying fluid (not shown). Referring to an embodiment, the hemostatic valve also includes a pressure regulating structure, and the pressure regulating structure is provided with a fluid pipeline for providing fluid, and the fluid pipeline is directly or indirectly connected to the balance chamber or the drive chamber or the balance hole.

[0219] The fluid pipeline can be directly connected to any one of the balancing chamber, the drive chamber or the balancing hole, or it can be directly connected to multiple ones, or it can be indirectly connected through the mutual connection among the balancing chamber, the drive chamber and the balancing hole. In actual products, there are many deformation methods, but from the implementation principle, the fluid in the fluid pipeline needs to be able to realize the function of filling the drive chamber. The fluid in the fluid pipeline is provided by a pressure regulating structure. The pressure regulating mechanism can choose the form of a plunger pump or a peristaltic pump commonly used in clinical practice, and it can also simplify the design and reduce production costs. For example, it can be a syringe-type delivery tube commonly used in clinical practice, or it can be a separate delivery device. It can be flexibly adjusted according to actual needs.

[0220] In terms of the specific connection relationship, in a reference embodiment, a plurality of balance chambers are provided and circumferentially distributed outside the driving chamber. Each balance chamber is communicated with the driving chamber through an independent balance hole; one side of each balance hole is linked with the driving chamber, and the other side extends radially to the outer peripheral wall of the housing. Each balance hole is closed on the outer peripheral wall or docked with a fluid pipeline. The balance hole itself extends to form a channel capable of communicating the driving chamber and the balance chamber. One end of the balance hole extending to the outer peripheral wall of the housing can be closed by a sealing material or opened and docked with a fluid pipeline for receiving fluid. The specific number of closed and open ones can be adjusted as needed.

[0221] The present invention also discloses an interventional instrument sealing method based on a hemostatic valve. The hemostatic valve includes a housing and a sealing film installed in the housing and having a tubular structure. The inner cavity of the tubular structure serves as an instrument channel and penetrates the housing. A driving chamber capable of filling fluid and an energy storage mechanism capable of being linked with the fluid are provided inside the housing. The interventional instrument sealing method includes:

[0222] Inject fluid into the driving chamber. The fluid drives the sealing film to close the instrument channel, and the fluid also acts on the energy storage mechanism to pre-store energy in the energy storage mechanism to maintain the state of the sealing film;

[0223] When an interventional instrument is inserted into the instrument channel, the sealing film is deformed by the extrusion of the interventional instrument and the energy storage mechanism is driven by the fluid to store energy;

[0224] When the interventional instrument is withdrawn from the instrument channel, the energy storage mechanism releases energy, and the sealing film is deformed by the fluid drive to close the instrument channel.

[0225] From the perspective of the hemostatic valve, the hemostatic valve includes:

[0226] A housing and a sealing film installed in the housing and having a tubular structure;

[0227] The sealing film has an inner surface and an outer surface. An instrument channel for inserting an instrument is formed on the inner surface of the sealing film;

[0228] The housing has an inner wall. A driving chamber is formed between the inner wall of the housing and the outer surface of the sealing film. The driving chamber is used for filling fluid;

[0229] The hemostatic valve further includes an energy storage mechanism capable of being linked with the fluid;

[0230] The driving chamber and / or is connected to a fluid pipeline.

[0231] From the perspective of the sealing method of the hemostatic valve:

[0232] Inject a predetermined fluid into the driving chamber through the fluid pipeline. The fluid in the driving chamber is linked with the energy storage mechanism, the energy storage mechanism stores energy, the sealing film closes, and the instrument channel is sealed;

[0233] Insert an instrument into the instrument channel, and the fluid in the drive chamber is linked with the energy storage mechanism, and the energy storage mechanism further stores energy.

[0234] In this embodiment, the design of the energy storage mechanism improves the variation range of the hemostatic valve, which can allow instruments with different outer diameters to pass through the instrument channel while ensuring the sealing effect, overcoming the contradiction between the feel of the intervention instrument passing through and the size range allowing the intervention instrument to pass through in the related art. Thus, the pressure in the drive chamber is automatically adjusted to improve the penetrability of the instrument.

[0235] In one embodiment, the drive chamber is further connected to a fluid pipeline, and is connected to an external fluid source through this fluid pipeline. In the specific setting of the fluid pipeline, referring to one embodiment, a control valve is arranged on the fluid pipeline. The control valve can realize functions such as flow regulation of the fluid pipeline. In the connection setting of the fluid pipe body, referring to one embodiment, the drive chamber is further connected to a balance chamber, and the fluid in the drive chamber is linked with the energy storage mechanism via the balance chamber; the connection mode between the fluid pipeline and the drive chamber is at least one of the following modes:

[0236] Directly connected to the drive chamber; or

[0237] Directly connected to the balance chamber; or

[0238] Directly connected between the drive chamber and the balance chamber.

[0239] When the fluid pipeline supplies fluid, power support is required from the fluid source. Referring to one embodiment, the external fluid source is provided by a pressure regulating structure. The pressure regulating mechanism has various setting modes. Referring to one embodiment, the driving mode of the pressure regulating structure is manual, electric or pneumatic. In the specific selection, the pressure regulating mechanism can select forms such as a plunger pump or a peristaltic pump commonly used in clinics, and can be flexibly adjusted according to actual needs. From the implementation principle of the pressure regulating mechanism, referring to one embodiment, the pressure regulating structure has at least one storage chamber, and the fluid pipeline is connected to this storage chamber.

[0240] In the specific setting of the balance chamber and the drive chamber, referring to one embodiment, a cylindrical space is formed in the housing, and the energy storage mechanism includes:

[0241] A piston, slidably arranged in the cylindrical space, and separating the cylindrical space into a balance chamber and an energy storage chamber;

[0242] An energy storage element, located in the energy storage chamber, and the energy storage element is a gas and / or an elastic member that acts on the piston.

[0243] In the matching manner of the cylindrical space and the housing, referring to one embodiment, the housing is annular and has an annular wall, and the cylindrical space is located within the annular wall.

[0244] The cylindrical space has various design forms. For example, the axis is in a curved form, and the cross-section of the cylindrical space changes, such as an irregular cylinder. To ensure the smooth operation of the energy storage mechanism and the processing difficulty, in reference to an embodiment, the cylindrical space is a straight cylinder structure, and the axis of the straight cylinder structure is parallel to the axis of the housing. In the specific selection of the cylindrical structure, in reference to an embodiment, the cylindrical space is one or more. Correspondingly, the number of cylindrical spaces is 2 to 8. Correspondingly, the cylindrical spaces are sequentially distributed along the circumferential direction of the housing.

[0245] The actual space provided by the cylindrical structure for the balance chamber and the drive chamber. In the overall mating relationship, in reference to an embodiment, the instrument channel penetrates the housing along the axis of the housing.

[0246] It can be easily seen from the above description that a sealing method can be obtained by using the hemostatic valve according to the operation method described in this application. Therefore, this application also discloses an interventional instrument sealing method, including constructing an instrument channel by using a deformable sealing film, deforming the sealing film by fluid drive 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 an energy storage mechanism linked with the fluid to store or release energy correspondingly when the sealing film deforms, so as to maintain the seal between the interventional instrument and the instrument channel.

[0247] In an embodiment, the interventional instrument sealing method is implemented according to the hemostatic valve in the above technical solution. The specific structural details of the hemostatic valve can be referred to the description of the hemostatic valve above, and will not be elaborated here.

[0248] The hemostatic valves in the above embodiments can all achieve the cooperation with the sheath. This application also discloses an expandable sheath, including a tube wall 204. The tube wall 204 is a rolled wall structure, and the cross-section is a coiled shape. The tube wall 204 has an expanded state in which the corresponding part of the rolled wall structure is expanded and a pre-shaped state in which it self-recovers the rolled wall structure.

[0249] In an embodiment, the tube wall 204 is made of an elastic material that can autonomously switch between the expanded state and the pre-shaped state.

[0250] In an embodiment, the outer diameter of the tube wall 204 in the pre-shaped state is 4 - 9 mm.

[0251] In an embodiment, the tube wall 204 in the pre-shaped state is wound more than one circumference, and the part exceeding the 360-degree circumference overlaps with the part within 360 degrees.

[0252] In an embodiment, the overlapping part has a smooth contact surface.

[0253] In an embodiment, the tube wall 204 in the pre-shaped state is wound less than 720 degrees.

[0254] In one embodiment, the starting side 209 and the ending side 210 of the coiled wall structure wound in the circumferential direction are connected by a flexible envelope film.

[0255] In one embodiment, a crease line is provided at the turning point of the flexible envelope film.

[0256] In one embodiment, the wall thickness of the flexible envelope film is 0.1 - 1 mm.

[0257] In one embodiment, the flexible envelope film is a circumferentially closed tubular structure, and the cross-sectional perimeter of the flexible envelope film tubular structure is greater than the wall length of the cross-section of the tube wall 204, and the tube wall 204 is fixedly attached to the outer wall of the flexible envelope film.

[0258] In one embodiment, an elastic sleeve 206 is wrapped around the outer periphery of the distal end of the tube wall 204.

[0259] In one embodiment, the distal end of the tube wall 204 is connected to the sheath handle, and the connection part is wrapped by the elastic sleeve 206.

[0260] In one embodiment, the axial length of the elastic sleeve 206 is 5 - 50 cm.

[0261] In one embodiment, a binding sleeve for limiting the tube wall 204 in a predetermined shape state is wrapped outside the tube wall 204, and the binding sleeve bursts under the expanded state of the tube wall 204.

[0262] In one embodiment, the binding sleeve axially extends out of the proximal end of the tube wall 204 along the tube wall 204, and the extended part is a necking structure.

[0263] In one embodiment, on the ending side 210 of the coiled wall structure wound in the circumferential direction, a chamfer structure is provided near the proximal end of the tube wall 204.

[0264] Specifically, refer to the appendix Figures 11a to 12f As shown, in this embodiment, the tube wall 204 of the sheath tube is a coiled wall structure, the cross-section is a coiled shape, and the tube wall 204 has an expanded state for expanding the coiled wall structure of the corresponding part and a predetermined shape state for restoring the coiled wall structure.

[0265] In the predetermined shape state, the outer diameter of the sheath tube is 5 mm (15 Fr), and the inner diameter is 4 mm. In the expanded state, the inner diameter can reach 8 mm (24 Fr), and the sheath tube can be transported through the corresponding diameter.

[0266] Refer to Figure 11b , a connector 205 cooperating with the conveying device is installed at the distal end of the sheath tube, and the connection part between the sheath tube and the connector 205 is wrapped by the elastic sleeve 206. It can prevent blood (or body fluid) from escaping from the gap at the overlapping part of the tube wall. The elastic sleeve is made of elastic nylon, and the thickness is 0.1 - 0.2 mm.

[0267] In the circumferential direction, the coiled wall structure spirally extends from the starting side to the ending side. The ending side boundary of the starting side can extend along the axial direction of the sheath tube or spirally extend around the axis of the sheath tube. Figure 11b It can be seen that the ending side boundary 207 is a straight line and extends along the axial direction of the sheath tube. When a spiral line is adopted, the force distribution during the bending of the sheath tube can be made more uniform.

[0268] Combined Figures 11c to 11f , the interventional device passes through from right to left. Wherever it passes, it will squeeze the inner side of the tube wall, causing the coiled wall structure of the tube wall to expand accordingly, and the compressed part 208 will turn into the expanded state.

[0269] After the interventional device 9 passes through, due to the elasticity of the tube wall 204 itself, it will recover automatically and return to the initial pre-shaped state.

[0270] In this embodiment, the material of the tube wall is selected from HDPE, Pebax, etc. In order to ensure that the tube wall can recover automatically and maintain a certain strength and compliance, the thickness of the tube wall is 0.5 mm.

[0271] See Figure 12a , which is a cross-sectional schematic diagram of the sheath tube in the pre-shaped state (initial state) when no device is implanted. In order to wrap and form the channel of the delivery sheath tube, the coiled tube wall in the pre-shaped state winds more than 360 degrees, that is, it extends more than 360 degrees circumferentially from the starting side 209 to the ending side 210 of the winding, and the part exceeding 360 degrees overlaps with the part not exceeding 360 degrees.

[0272] Figure 12a As can be seen in , the exceeding part 211 and the non-exceeding part 212 overlap with each other. The exceeding part 211 is wrapped around the outer periphery of the non-exceeding part 212, and a complete channel is formed inside the tube wall.

[0273] Figure 12c This is a cross-sectional schematic diagram of the sheath tube when it is expanded during the implantation of the interventional device 9. In order to prevent the delivery sheath tube and the implanted device from being exposed under the expanded state, Figure 12c It can be seen that the coiled tube wall in the expanded state winds more than or equal to 360 degrees, that is, there is still an overlapping area 213.

[0274] Figure 12e In , that is, the overlapping area 213 is increased, and the degree of winding of the tube wall, that is, the corresponding central angle, is further increased to 540 degrees. After it is expanded, a larger inner diameter will be obtained, allowing a thicker interventional device 9 to pass through.

[0275] Such as Figure 12aAs shown, although the protruding part 211 and the non-protruding part 212 overlap with each other, they are not relatively fixed and can slide relative to each other to form a gap, allowing blood or body fluid to potentially enter and exit the tube wall. In order to form a closed channel for the interventional device in different states, the present invention provides another implementation manner by closing the tube wall in the form of flexible envelope membranes provided on the starting side and the ending side of the tube wall.

[0276] Figure 12b In [description], the starting side 209 and the ending side 210 of the wound tube wall are connected by a flexible envelope membrane 214. The flexible envelope membrane mainly provides a radial supporting force to restrain the implanted device and prevent it from being exposed, and at the same time can also prevent blood or body fluid from overflowing the tube wall.

[0277] Since the flexible envelope membrane 214 needs to be folded or twisted when the tube wall switches states, its wall thickness and stiffness are lower than those of the tube wall itself. In this embodiment, the flexible envelope membrane 214 is made of PTFE material with a wall thickness of 0.25 - 0.5 mm.

[0278] Regardless of the state of the tube wall, the flexible envelope membrane 214 can maintain the closure of the sheath tube, and the flexible envelope membrane 214 can be fixed to the tube wall by means such as welding.

[0279] To accommodate the flexible envelope membrane 214, the flexible envelope membrane 214 is located in the middle layer of the overlapping part of the tube wall. The flexible envelope membrane 214 can extend circumferentially for a certain length, that is, it does not envelope the entire inner cavity of the tube wall by 360°. In the pre-shaped state, the flexible envelope membrane 214 is tightened between the starting side 209 and the ending side 210 of the wound tube wall. The function of the flexible envelope membrane 214 is to close the gap formed between the starting side 209 and the ending side 210 and prevent blood or body fluid from entering and exiting the tube wall. Therefore, the fixing points of the flexible envelope membrane 214 to the tube wall are not strictly required to be at the starting side 209 and the ending side 210 and can be appropriately adjusted.

[0280] Figure 12d In [description], as another implementation manner, the flexible envelope membrane 214 is a circumferentially closed tubular structure, and the tube wall is fixedly attached to the outer wall of the flexible envelope membrane 214. A part of the flexible envelope membrane 214 is a detour part 215, and the detour part 215 is located between the starting side 209 and the ending side 210 of the tube wall.

[0281] At the turning points 216 and 217 of the detour part 215, there are crease lines, and the crease lines can be processed by heat setting. In the pre-shaped state, the crease lines can make the turning points of the detour part smoother.

[0282] See Figure 12f , the detour part 215 unfolds when the tube wall is in the expanded state, allowing the tube wall to have a larger deformation range.

[0283] 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 as 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 simultaneously disclosing the combination examples of the various embodiments involved.

[0284] The above-described embodiments only express several implementation manners of the present application. The description 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. Hemostatic valve with multiple cavities, comprising a housing and a sealing film installed in the housing and having a tubular structure, the inner cavity of the tubular structure serving as an instrument channel, characterized in that, Radially along the instrument channel, a driving chamber for filling fluid is provided inside the housing around the periphery of the sealing film, and a balance chamber is located outside the driving chamber. The driving chamber and the balance chamber are in communication with each other, and the balance chamber surrounds the outer periphery of the driving chamber. The hemostatic valve further includes an energy storage mechanism that can be linked with the fluid. The fluid in the driving chamber is linked with the energy storage mechanism via the balance chamber. The energy storage mechanism stores or releases energy correspondingly when the state of the sealing film changes, and drives the sealing film to seal the instrument channel when releasing energy. At least the outer periphery of the driving chamber of the housing is a rigid structure, and a cylindrical space is formed inside the housing. The energy storage mechanism includes: A piston, slidably arranged in the cylindrical space, and separating the cylindrical space into the balance chamber and the energy storage chamber. An energy storage element, located in the energy storage chamber, and the energy storage element is a gas and / or elastic member that acts on the piston.

2. The hemostatic valve according to claim 1, characterized in that, There are multiple balance chambers, which are arranged at intervals around the outer periphery of the driving chamber, and the energy storage mechanism is configured for each balance chamber respectively.

3. The hemostatic valve according to claim 2, characterized in that, The number of the balance chambers is 2 to 8; the balance chambers are arranged at intervals evenly or unevenly around the outer periphery of the driving chamber.

4. The hemostatic valve according to claim 2, characterized in that, Each balance chamber is communicated with the driving chamber through an independent balance hole; or At least two balance chambers share the same balance hole to communicate with the driving chamber.

5. The hemostatic valve according to claim 2, characterized in that, Each balance chamber is communicated with the driving chamber through the same balance hole.

6. The hemostatic valve according to claim 5, characterized in that, The housing is annular and has an annular wall, and the cylindrical space is located inside the annular wall.

7. The hemostatic valve according to claim 5, characterized in that, The cylindrical space is a straight cylinder structure, and the axis of the straight cylinder structure is parallel to the axis of the housing.

8. The hemostatic valve according to claim 1, characterized in that, The instrument channel penetrates the housing along the axis of the housing.

9. The hemostatic valve according to claim 5, characterized in that, The number of the cylindrical spaces is 2 to 8.

10. The hemostatic valve according to claim 9, characterized in that, The cylindrical spaces are distributed in sequence along the circumferential direction of the housing.

11. The hemostatic valve according to claim 5, characterized in that, Each piston is in sealing cooperation with the inner wall of the corresponding cylindrical space through a sealing edge on its outer edge. In the sliding direction of the piston, at least two seals are provided between the sealing edge and the inner wall of the cylindrical space.

12. The hemostatic valve according to claim 5, characterized in that, At least two cylindrical spaces for the piston to slide are provided on the housing, and independent energy storage elements are provided in each cylindrical space, and the energy storage performances of the energy storage elements are the same or different.

13. The hemostatic valve according to claim 4, characterized in that, The hemostatic valve further includes a pressure regulating structure. The pressure regulating structure is provided with a fluid pipeline for providing the fluid, and the fluid pipeline is directly or indirectly communicated with the balance chamber or the driving chamber or the balance hole.

14. The hemostatic valve according to claim 13, characterized in that, There are multiple balance chambers, which are circumferentially distributed outside the driving chamber. Each balance chamber is communicated with the driving chamber through an independent balance hole; one side of each balance hole is linked with the driving chamber, and the other side extends radially to the outer peripheral wall of the housing, and each balance hole is closed on the outer peripheral wall or docked with the fluid pipeline.

15. Catheter sheath, comprising a sheath tube extending axially, the sheath tube having an axially through cavity, the sheath tube having a proximal end and a distal end, characterized in that, The proximal end of the sheath is connected with the hemostatic valve according to any one of claims 1 to 14.

16. The catheter sheath according to claim 15, characterized in that, A pipe joint connected with the sheath is provided on the hemostatic valve. The pipe joint is matched with the sheath through a sealing member, and the pipe joint is provided with a clamping structure for preventing the sheath from separating from the pipe joint.

17. The catheter sheath according to claim 15, characterized in that,A developing ring is provided at the distal end of the sheath.

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