CN113117227A

CN113117227A - Self-adaptive hemostatic valve, catheter sheath and interventional instrument sealing method

Info

Publication number: CN113117227A
Application number: CN201911422103.6A
Authority: CN
Inventors: 王翔; 郭烽; 赵银涛; 李雅茹; 张志飞
Original assignee: Hangzhou Qiming Medical Devices Co ltd
Current assignee: Hangzhou Qiming Medical Devices Co ltd; Venus Medtech Hangzhou Inc
Priority date: 2019-12-31
Filing date: 2019-12-31
Publication date: 2021-07-16

Abstract

The application discloses self-adaptation hemostasis valve, pipe sheath and intervene sealed method of apparatus, self-adaptation hemostasis valve includes the casing and installs in the casing and be the sealing membrane of tubular structure, the inner chamber of tubular structure is as the apparatus passageway and link up the casing, be equipped with in the casing and be located the sealing membrane periphery and be used for the drive chamber of filling fluid, self-adaptation hemostasis valve still includes the energy storage mechanism that can link together with fluid, corresponding energy storage or the release when the sealing membrane state changes of energy storage mechanism, and drive the sealing membrane sealed instrument passageway of closing when releasing energy. According to the technical scheme disclosed by the application, the deformation energy of the sealing film is stored through the design of the energy storage mechanism, so that the good compatibility and the good sealing effect of different instruments passing through are realized; through the setting of seal membrane self parameter, the parameter setting of energy storage structure and the matching between the two, realize that the apparatus draws the operation and feels good, operating force changes little advantage to provide the structure basis for other functions.

Description

Self-adaptive hemostatic valve, catheter sheath and interventional instrument sealing method

Technical Field

The present application relates to the field of medical devices, and more particularly to an adaptive hemostatic valve, a catheter sheath, and a method of sealing an interventional device.

Background

Interventional therapy is a leading-edge treatment technique developed in recent years between drug administration and open surgery. Interventional therapy generally requires guiding medical imaging devices such as X-ray fluoroscopy, CT positioning, B-mode ultrasound, etc., and a catheter device loaded with interventional devices (such as vascular stents, artificial heart valves) or drugs reaches a diseased region in a body through arteries and veins of the body, so as to achieve the purpose of diagnosing and treating diseases.

The sheath provides a passageway for the catheter device to enter the body and also creates an outflow port for blood or other body fluids. To prevent blood loss, it is often necessary to provide a sealing hemostatic valve within the catheter sheath. The problem in the prior art solutions is that a contradiction arises between the sealing function of the haemostatic valve and the passable function for facilitating the passage of an interventional instrument. To prevent blood from escaping, it is often desirable to improve the sealing properties, but the penetrability of the interventional device within the haemostatic valve is correspondingly affected.

Technical improvements directed to hemostatic valves are also disclosed in the related art. For example, in a related art, the hemostatic valve includes a housing and a tubular sealing membrane located in the housing, an annular sealed cavity is defined between an outer periphery of the tubular sealing membrane and the housing, and the size of the sealed cavity is adjusted by injecting a filler into the sealed cavity, so as to achieve opening and closing of the hemostatic valve. The inventor finds that the sealing membrane can generate larger friction with an interventional instrument after being sealed, the pressure of the sealed cavity needs to be frequently adjusted to adjust the sealing state of the sealing membrane in order to conveniently operate the interventional instrument relative to the position of the hemostatic valve, the operation is more complicated, the precision control difficulty is higher, and the treatment process is influenced.

Disclosure of Invention

In order to solve the technical problem, the application discloses self-adaptation hemostasis valve, include the casing and install in the casing and be the seal membrane of tubular structure, the inner chamber of tubular structure just link up as the apparatus passageway the casing, be equipped with in the casing and be in the seal membrane periphery is used for the drive chamber of fluid filling, self-adaptation hemostasis valve still include can with the energy storage mechanism that fluid linked mutually, energy storage mechanism is in corresponding energy storage or energy release when sealed membrane state changes, and order about when energy release the seal membrane is sealed to be closed the apparatus passageway.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the adaptive hemostasis valve has an operating state in which the drive chamber is filled with a fluid, and an initial state in which the drive chamber is not filled with the fluid, the fluid being an incompressible liquid.

Optionally, the fluid is saline or water.

Optionally, the sealing membrane has a first state pressed by an interventional instrument to open an instrument channel, and the energy storage mechanism is driven by fluid to store energy;

the sealing membrane has a second state that is driven by fluid to close the instrument channel, and the stored energy mechanism is de-energized to maintain fluid pressure that holds the sealing membrane in the second state.

Optionally, the housing is of rigid construction at least at the periphery of the drive chamber.

Optionally, the housing is a rigid structure as a whole.

Optionally, the housing is made of a transparent material.

Optionally, a through area is formed in the shell, the sealing film is arranged in the through area, and the driving chamber is defined by the periphery of the sealing film and the inner wall of the through area.

Optionally, the two open ends of the through area are respectively provided with a first end cover and a second end cover in a sealing manner, each end cover is provided with an avoiding hole corresponding to the instrument channel, and the two axial ends of the sealing membrane are clamped and fixed between the shell and the end covers on the corresponding sides.

Optionally, one end of the instrument channel is an instrument inlet, the other end of the instrument channel is an instrument outlet, and an end cover located on one side of the instrument outlet is provided with a radially-communicated exhaust hole.

Optionally, the exhaust hole is communicated with an exhaust valve;

the exhaust valve is directly arranged on the exhaust hole or is communicated with the exhaust hole through an external pipeline.

Optionally, each end cap is secured to the housing by screws.

Optionally, a balance chamber is further arranged in the shell, the driving chamber is communicated with the balance chamber, and fluid in the driving chamber is linked with the energy storage mechanism through the balance chamber.

Optionally, the balancing chamber is located outside the driving chamber in a radial direction of the instrument channel.

Optionally, the balance chamber surrounds the periphery of the drive chamber.

Optionally, the balance chamber is in open communication with the drive chamber.

Optionally, the driving chamber and the balancing chamber are isolated from each other and are communicated only through the balancing hole.

Optionally, one end of the instrument channel is an instrument inlet, the other end of the instrument channel is an instrument outlet, and the balance hole is adjacent to the instrument outlet.

Optionally, a first pressure adjusting hole is formed in a wall of the balance chamber or the driving chamber.

Optionally, the first pressure adjusting hole is communicated with a first adjusting valve;

the first regulating valve is directly arranged in the first pressure regulating hole or is communicated with the first pressure regulating hole through an external pipeline.

Optionally, the energy storage mechanism comprises an energy storage chamber and an energy storage element installed in the energy storage chamber, and the energy storage element stores or releases energy correspondingly when the state of the sealing membrane changes, so as to drive the sealing membrane to seal the instrument channel.

Optionally, the energy storage mechanism includes:

the energy storage chamber; a balance chamber is also arranged in the shell, and the driving chamber is communicated with the balance chamber;

a piston sealingly sliding between the balance chamber and the energy storage chamber;

the energy storage element is a compressible gas and/or an elastic element which is positioned in the energy storage chamber and interacts with the piston.

Optionally, a second pressure adjusting hole is formed in the chamber wall of the energy storage chamber.

Optionally, one end of the instrument channel is an instrument inlet, the other end of the instrument channel is an instrument outlet, the balancing chamber is adjacent to the instrument outlet along the axial direction of the instrument channel, and the energy storage chamber is adjacent to the instrument inlet.

Optionally, one side of the energy storage chamber, which faces away from the balance chamber, is an open structure, and a third end cover is hermetically mounted on the energy storage chamber, and the second pressure adjusting hole is formed in the third end cover.

Optionally, the second pressure adjusting hole is communicated with a second adjusting valve;

the second regulating valve is directly arranged in the second pressure regulating hole or is communicated with the second pressure regulating hole through an external pipeline.

Optionally, an adjusting member abutting against the elastic member is disposed in the energy storage chamber, and at least a portion of the adjusting member is exposed to the energy storage chamber and serves as an adjusting operation portion.

Optionally, one side of the energy storage chamber facing away from the balance chamber is an open structure and is hermetically provided with a third end cover, and the adjusting member is arranged on the third end cover.

Optionally, the adjusting part is an adjusting screw in threaded fit with a wall of the energy storage chamber, a head of the adjusting screw is used as the adjusting operation part, and one end of the adjusting screw opposite to the head is in abutting fit with the elastic part.

Optionally, the movement direction of the piston and the extension direction of the instrument channel are parallel or at an angle.

Optionally, the energy storage element is an elastic bag disposed in the energy storage chamber.

Optionally, the elastic bladder is suspended within the balancing chamber or is fixed to a chamber wall of the balancing chamber.

Optionally, the elastic bag is fixed to a chamber wall of the balance chamber, and a third pressure adjusting hole communicated with the elastic bag is formed in the chamber wall of the balance chamber.

Optionally, the third pressure adjusting hole is communicated with a third adjusting valve;

the third regulating valve is directly installed in the third pressure regulating hole or is communicated with the third pressure regulating hole through an external pipeline.

Optionally, the elastic bag is of a hollow structure, and is filled with gas, and the gas stores or releases energy.

Optionally, the elastic bag is made of an elastic material, and energy is stored or released through deformation of the elastic material.

Optionally, a hydrophilic lubricating coating is arranged on the inner cavity of the sealing film.

The application also discloses a catheter sheath, including body and the self-adaptation hemostasis valve of mutual butt joint intercommunication, the self-adaptation hemostasis valve is according to among the above-mentioned technical scheme.

Optionally, be equipped with on the self-adaptation hemostasis valve with the coupling that the body is connected, the coupling pass through the sealing member with the body cooperation, just the coupling has to be equipped with and prevents the body with the block structure of coupling separation.

The application also discloses an interventional instrument sealing method, which comprises the steps of constructing an instrument channel by utilizing the deformable sealing membrane, and driving the sealing membrane to deform by fluid at the periphery of the sealing membrane so as to seal the instrument channel.

Optionally, the interventional device sealing method is implemented according to the adaptive hemostatic valve in the above technical solution.

According to the technical scheme disclosed by the application, the deformation energy of the sealing membrane is stored through the design of the energy storage mechanism, and the posture and the form of the sealing membrane can be adjusted in a self-adaptive manner in the process that the instrument and the self-adaptive hemostatic valve generate relative displacement, so that good compatibility and good sealing effect are realized when different instruments pass through; through the setting of the self parameters of the sealing film, the setting of the parameters of the energy storage structure and the matching between the self parameters and the energy storage structure, the advantages of good drawing operation feeling and small change of the operation force of the instrument are realized, and a structural basis is provided for adjusting the hand feeling of the drawing instrument.

Specific advantageous technical effects will be further explained in conjunction with specific structures or steps in the detailed description.

Drawings

FIG. 1a is a schematic view of an embodiment of a hemostatic valve in an initial state;

FIG. 1b is a schematic view of the housing of the stop valve of FIG. 1 a;

FIG. 1c is a schematic view of the hemostatic valve of FIG. 1a in an operational state;

FIG. 1d is a schematic view of the instrument entering the stop blood valve of FIG. 1 c;

FIG. 2a is a schematic view of another embodiment of a hemostatic valve in an initial state;

FIG. 2b is a schematic view of the hemostatic valve of FIG. 2a in an operational state;

FIG. 2c is a schematic view of the instrument entering the stop blood valve of FIG. 2 b;

FIG. 2d is a schematic view of another embodiment of the hemostatic valve of FIG. 2a in an initial state;

FIG. 2e is a schematic view of the hemostatic valve of FIG. 2d in an operating state;

FIG. 2f is a schematic view of the instrument entering the stop blood valve of FIG. 2 e;

FIG. 3 is a schematic view of an adjuster mechanism;

FIG. 4a is a schematic view of an initial state of a hemostatic valve according to yet another embodiment;

FIG. 4b is a schematic view of the hemostatic valve of FIG. 4a in an operational state;

FIG. 4c is a schematic view of the instrument entering the stop blood valve of FIG. 4 b;

FIG. 5a is a schematic view of another embodiment of the hemostatic valve of FIG. 4a in operation;

FIG. 5b is a schematic view of the instrument entering the stop blood valve of FIG. 5 a;

FIG. 5c is a schematic view of an operating condition of another embodiment of the hemostatic valve of FIG. 4 a;

fig. 6a and 6b are schematic views showing the fitting relationship between the tube body of the catheter sheath and the hemostatic valve.

The reference numerals in the figures are illustrated as follows:

1. a housing; 11. an instrument channel; 12. a drive chamber; 13. a pass-through region; 14. a first end cap; 15. a second end cap; 16. an exhaust hole;

2. a sealing film; 21. an inner cavity;

3. an energy storage mechanism; 31. a balancing chamber; 311. a balance hole; 32. a first pressure regulating hole; 33. an energy storage chamber; 331. a second pressure regulating hole; 332. a third end cap; 34. a piston; 341. an elastic member; 342. an adjustment member; 343. an adjustment operation section; 35. an elastic bag; 351. a third pressure regulating hole;

9. an interventional instrument; 91. a tube body.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1a to 5c, the application discloses an adaptive hemostatic valve, which includes 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 penetrates through the housing 1, a driving chamber 12 located at the periphery of the sealing membrane 2 and used for filling fluid is disposed in the housing 1, the adaptive hemostatic valve further includes an energy storage mechanism 3 capable of being linked with the fluid, the energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes, and drives the sealing membrane 2 to seal the instrument channel 11 when releasing energy.

The function of the sealing membrane 2 is in fact to separate two mutually independent spaces, namely the instrument channel 11 and the drive chamber 12, within the housing 1, which are separated by the sealing membrane 2. Wherein the instrument channel 11 is open at both ends for the passage of the interventional instrument 9, whereby the sealing of the sealing membrane 2 refers to the sealing of the drive chamber 12.

The sealing membrane 2 itself is of tubular construction, the lumen 21 serving as the instrument channel 11. In order to ensure that the interventional device 9 passes through the housing 1, the device channel 11 needs to penetrate through the housing 1, and the actual length of the device channel 11 is greater than the effective length of the housing 1 in the length direction of the device channel 11; in an actual product, the sealing membrane 2 may be entirely disposed in the housing 1, and the effective length of the sealing membrane 2 in the length direction of the instrument channel 11 may be smaller than the effective length of the housing 1 in the length direction of the instrument channel 11; the inner space 21 of the sealing membrane 2 is therefore to be understood as meaning that the inner space 21 of the sealing membrane 2 forms at least a part of the instrument channel 11, it being possible for the instrument channel 11 to extend in the longitudinal direction of the inner space 21 of the sealing membrane 2.

In an interacting relationship, the drive chamber 12 is capable of driving the sealing membrane 2 to change its state, thereby effecting closure or opening of the instrument channel 11. The instrument channel 11 is a passage for the interventional instrument 9 (e.g. a catheter, a guide wire, etc.) into and out of the body during an interventional procedure, and it is therefore understood that the area enclosed by the tubular structure is at least a part of the instrument channel 11. In order to cooperate with the entrance of the interventional device 9, the housing 1 is correspondingly provided with an inlet and an outlet which are communicated with the device channel 11, and the device channel 11 can also be regarded as penetrating through the housing 1. The function of the drive chamber 12 is to confine the fluid and direct the fluid work onto the sealing membrane 2. When the sealing membrane 2 is used for closing the instrument channel 11, at least a part of the tubular structure of the sealing membrane 2 tends to be gathered in a radial direction, so that the cavity diameter of the instrument channel 11 is reduced until the instrument channel 11 is closed. With or without the interventional instrument 9 in the instrument channel 11, the sealing membrane 2 can both effect a closing of the instrument channel 11 or an opening of the instrument channel 11. When the interventional device 9 is positioned in the device channel 11, the inner cavity 21 of the sealing membrane 2 is radially folded and is matched with the interventional device 9 to seal the device channel 11; when the interventional instrument 9 is not in the instrument channel 11, the lumen 21 of the sealing membrane 2 is radially collapsed until it closes against one another to close the instrument channel 11.

In principle, it is possible to analyze that the fluid-driven sealing membrane 2 is mainly realized by pressure, and when the fluid pressure in the drive chamber 12 is sufficient to overcome the resistance in the instrument channel 11, the drive chamber 12 is able to drive the sealing membrane 2 to deform itself to change the inner cavity 21 of the sealing membrane 2. The sealing effect of a particular instrument channel 11 depends on the magnitude of the fluid pressure in the drive chamber 12. Varying the amount of fluid pressure within the drive chamber 12 can take a variety of forms, such as externally connecting a pressure source, varying the temperature of the fluid, varying the physical characteristics of the fluid, and the like. The energy storage mechanism 3 in this embodiment can adaptively adjust the pressure state of the fluid. When the sealing membrane 2 changes state, the energy storage means 3 can store or release energy accordingly and use the stored energy to drive the sealing membrane 2 to seal the instrument channel 11. Compared with the design form of the external energy source, the technical scheme of the embodiment can effectively improve the integration level of the self-adaptive hemostatic valve and improve the degree and effect of the conversion form of the sealing membrane 2, thereby providing a structural basis for designing the instrument channel 11 with a larger cavity diameter and the interventional instruments 9 with different appearance sizes.

The tubular structure of the sealing membrane 2 mentioned in the present application is not limited to a strictly circular tube, and in practical products, the inner diameter of the inner cavity of the sealing membrane 2 may vary in the axial direction, and in cross section, the inner cavity of the sealing membrane 2 may have a regular shape such as a rectangle, a regular shape such as an hourglass shape, a pear shape, a spherical shape, and the like, and may have an irregular varying shape.

In one embodiment, the inner cavity of the sealing membrane 2 is provided with a hydrophilic lubricious coating (not shown). The inner cavity of the sealing membrane 2 is the part which is actually contacted with the interventional instrument 9, and the hydrophilic lubricating coating can reduce the friction force of the inner cavity of the sealing membrane 2, so that the interventional instrument 9 can conveniently pass through the instrument channel 11 under the condition that pressure difference exists between the inside and the outside of the sealing membrane 2. Meanwhile, the hydrophilic lubricating coating can also realize other functions by adjusting the coating material. For example, the life of the sealing film 2 is increased by adding an abrasion resistant material to the coating material; for another example, the physicochemical properties of the coating surface are adjusted to achieve self-cleaning of the sealing film 2, and the like.

The direct energy of the sealing membrane 2 comes from the drive chamber 12. In one embodiment, the adaptive hemostasis valve has an operating state in which the drive chamber 12 is filled with a fluid (e.g., fig. 1c), and an initial state in which the drive chamber is not filled with a fluid (e.g., fig. 1a), the fluid being an incompressible liquid.

In the initial state, the driving chamber 12 should be filled with air at normal pressure; in some products used in special situations, a vacuum may be provided in the drive chamber 12 in the initial state. In this embodiment, incompressible liquid means incompressible in a relative sense to gas, not in an absolute sense. The incompressible property of the liquid can facilitate the accurate control of the deformation degree of the sealing membrane 2 by operators such as medical staff. Specifically, in one embodiment, the fluid is saline or water. The advantage of saline or water as the fluid mentioned above is that it is conveniently available in the medical field, and more importantly, even if the sealing action of the sealing membrane 2 fails in an accidental situation, the fluid does not affect the intervention site, ensuring safety.

The energy storing means 3 can improve the working performance of the sealing membrane 2 during the working of the sealing membrane 2. In particular, in one embodiment, the sealing membrane 2 has a first state (e.g. fig. 1d) pressed by the interventional instrument 9 to open the instrument channel 11, the energy storing means 3 being fluid-driven to store energy; as can be easily understood, in the energy storage state of the energy storage mechanism 3, the fluid has a higher pressure to ensure the closed state of the instrument channel 11; i.e. the energy storing means 3 in the energy storing state still drives the sealing membrane 2 to seal the instrument channel 11.

The sealing membrane 2 has a second state (e.g. fig. 1c) which is driven by fluid to close the instrument channel 11, the stored energy mechanism 3 being de-energized to maintain fluid pressure holding the sealing membrane 2 in the second state.

In actual use, there is a contradiction in the choice of the preset pressure of the fluid in the drive chamber 12 for different conditions of the interventional instrument 9 in the instrument channel 11, for example in a solution where no energy storing means 3 is provided:

the sealing membrane 2 needs to open the instrument channel 11 to avoid interference with the interventional instrument 9 when the interventional instrument 9 enters the adaptive hemostasis valve. The sealing membrane 2 will therefore perform work on the fluid in the drive chamber 12. If the preset pressure of the fluid in the driving chamber 12 is too high, the driving force requirement for deformation of the sealing membrane 2 is too high, and the interventional device 9 needs a larger driving force to extrude the sealing membrane 2 to open the device channel 11, so that the use of medical staff and other operators is influenced; if the predetermined pressure of the fluid in the driving chamber 12 is too low, the sealing pressure of the sealing membrane 2 in the state of closing the instrument channel 11 is insufficient, and the sealing is liable to fail.

The energy storage mechanism 3 in this embodiment can well overcome the above-mentioned problems. The sealing membrane 2 needs to open the instrument channel 11 to avoid interference with the interventional instrument 9 when the interventional instrument 9 enters the adaptive hemostasis valve. At the moment, the sealing film 2 can do work on the fluid in the driving chamber 12, and meanwhile, the energy storage mechanism 3 stores energy to absorb the energy of the fluid so as to reduce the entering difficulty of the interventional device 9 and provide good hand feeling for the entering process of the interventional device 9; when the interventional instrument 9 exits the adaptive hemostasis valve, the sealing membrane 2 needs to close the instrument channel 11 to function as the adaptive hemostasis valve. At the moment, the fluid in the driving chamber 12 applies work to the sealing membrane 2, and meanwhile, the energy storage mechanism 3 releases energy to realize the work on the fluid, so that the sealing effect of the sealing membrane 2 on the instrument channel 11 is ensured.

The sealing membrane 2 is in the process of changing, in fact the process of the fluid and the sealing membrane 2 doing work with each other. To ensure the effectiveness of the work, in one embodiment, the housing 1 is of rigid construction at least at the periphery of the drive chamber 12.

The shell 1 can limit the work of the driving chamber 12 in other directions, so that the energy of the fluid is ensured to act on the sealing film 2, and the deformation stroke and the sealing effect of the sealing film 2 are improved under the condition of certain energy. The rigidity mentioned in the present embodiment is relative to the flexible sealing film 2 that can be deformed, and is not rigidity of a rigid body in terms of physical concept. In a practical product, the housing 1 may be made of plastic or the like, and may be slightly deformed by the fluid, but the slight deformation does not affect the working effect of the sealing film 2. The following description of rigidity holds true. In different products, the housing 1 may be a common material such as metal, plastic, etc., or may be an organic material or an inorganic material; synthetic or natural materials, etc. are also possible.

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

Since the fluid exerts a force on surrounding components, the housing 1 may be deformed when the fluid pressure is high. In the solution in which the casing 1 is not entirely rigid, the casing 1 may deform to dissipate the energy of the fluid, affecting the working effect of the sealing membrane 2. The technical scheme in the embodiment can overcome the problem.

In order to facilitate the observation of the state of the sealing film 2, in one embodiment, the case 1 is made of a transparent material.

In principle, the transparent material is relative to the material which cannot observe the inside, so as long as the design of the internal structure can be observed and the use requirement in the embodiment can be met, the transparent expression type in the embodiment, such as the translucent material, etc., can be considered. Accordingly, in some particular embodiments, the transparency may be local. For example, the observation window is provided at a portion where the internal structure needs to be observed. In the matching relationship between the housing 1 and the sealing film 2, in one embodiment, a through region 13 is formed in the housing 1, the sealing film 2 is disposed in the through region 13, and a driving chamber 12 is defined between the outer periphery of the sealing film 2 and the inner wall of the through region 13.

The through-region 13 accommodates the sealing membrane 2, so that the influence of the external environment on the through-region 13 from directions other than the instrument channel 11 is avoided, and the stability of the operation of the sealing membrane 2 can be improved. Meanwhile, the through area 13 also participates in forming the driving chamber 12, so that the component integration level of the self-adaptive hemostatic valve is improved, the whole volume of the self-adaptive hemostatic valve is favorably controlled, and the use in the treatment process is convenient.

In one embodiment, the two open ends of the through region 13 are respectively and hermetically mounted with a first end cap 14 and a second end cap 15, each end cap is provided with an avoiding hole corresponding to the instrument channel 11, and the two axial ends of the sealing membrane 2 are clamped and fixed between the housing 1 and the end cap on the corresponding side.

The first end cap 14 and the second end cap 15 are able to fix the sealing membrane 2, thereby guiding the working direction of the sealing membrane 2. The avoiding hole can also play a guiding role in the working process, so that the contact position of the interventional device 9 and the sealing film 2 when the interventional device 9 enters the device channel 11 is ensured, and the possibility of damaging the sealing film 2 by the interventional device 9 is reduced.

In one embodiment, one end of the instrument channel 11 is an inlet of the interventional instrument 9, the other end is an outlet of the interventional instrument 9, and an end cover located at one side of the outlet of the interventional instrument 9 is provided with a radially penetrating exhaust hole 16.

When the medical device such as a catheter entering a body is used, the gas in the device is generally required to be exhausted, and the exhaust hole 16 can overcome the problem that the gas is carried before the device is used. At the same time, the operator may remove the gas inside the adaptive hemostatic valve by injecting saline into the vent 16 prior to use. Further, the vent 16 itself is also an interface that can provide a structural basis for special operations in a particular use scenario.

In the arrangement of the exhaust hole 16, in an embodiment, the exhaust hole 16 is communicated with an exhaust valve (not shown);

the exhaust valve is directly installed at the exhaust hole 16 or is communicated with the exhaust hole 16 through an external pipe.

The flexible arrangement of the exhaust valve can be adjusted according to the use requirements of different cases. For example, the design that the exhaust valve is directly arranged on the exhaust hole 16 can improve the integration level of the self-adaptive hemostatic valve, and is convenient for operation of medical staff and other operators; further, for example, the vent valve is connected to the vent hole 16 via an external pipe to further reduce the external dimension of the adaptive hemostatic valve, thereby providing adaptability.

In assembled relation of the components, in one embodiment, each end cap is secured to the housing 1 by screws (not shown).

The end cap needs to form a relatively closed space inside the housing 1 and in some embodiments also needs to secure the sealing membrane 2, so the stability of the mounting of the end cap is related to the stability of the operation of the adaptive hemostatic valve. The end cover can be installed through the structure of the end cover, and in order to improve the convenience degree of installation, a screw is reasonable and preferable.

In the design of the energy storage mechanism 3, in an embodiment, a balance chamber 31 is further provided in the housing 1, the driving chamber 12 and the balance chamber 31 are communicated with each other, and the fluid in the driving chamber 12 is linked with the energy storage mechanism 3 through the balance chamber 31.

The balancing chamber 31 serves to restrict the movement of the energy storing mechanism 3, and in particular embodiments, the balancing chamber 31 may also be in large area communication with the driving chamber 12. The concept of the balancing chamber 31 therefore needs to be understood from the principle of the energy storage mechanism 3, rather than a space which is structurally relatively isolated from the drive chamber 12. For example, in one embodiment, the balance chamber 31 is in open communication with the drive chamber 12 (not shown).

In the design details of the balancing chamber 31, in one embodiment, the balancing chamber 31 is located outside the drive chamber 12 in the radial direction of the instrument channel 11.

The driving chamber 12 is a member for directly driving the sealing film 2 to work, and it is reasonable to design the sealing film 2 to be close to each other. The design of the balance chamber 31 outside the driving chamber 12 in the radial direction of the instrument channel 11 can reduce the length of the adaptive hemostatic valve in the axial direction of the instrument channel 11, thereby facilitating the operation during the treatment process.

In one embodiment, the balance chamber 31 surrounds the periphery of the drive chamber 12.

When the interventional device 9 enters the device channel 11, the fluid can be radially diffused by being pressed by the sealing film 2, and the balance chamber 31 is designed to be capable of receiving the diffusion tendency of the fluid at the periphery and has good dynamic response.

The balancing chamber 31 has a function of restraining the energy stocking mechanism 3. In one embodiment, the driving chamber 12 and the balance chamber 31 are isolated from each other and communicate only through the balance hole 311.

The balance hole 311 is used for allowing the fluid to pass through so as to realize the energy storage mechanism 3 to store or release the energy to the fluid in the driving chamber 12. The design that the driving chamber 12 and the balance chamber 31 are isolated from each other can avoid the influence of the fluid in the driving chamber 12 on the operation of the energy storage mechanism 3, so that the stability of the operation of the energy storage mechanism 3 is improved.

In one embodiment, the instrument channel 11 has an inlet for the interventional instrument 9 at one end and an outlet for the interventional instrument 9 at the other end, and the balancing hole 311 is disposed adjacent to the outlet for the interventional instrument 9.

The instrument channel 11 is a channel through which the interventional instrument 9 enters the adaptive hemostasis valve, and there may be a process in which the interventional instrument 9 first contacts a portion of the sealing membrane 2 during the process of entering the adaptive hemostasis valve by the interventional instrument 9. Accordingly, the fluid in the drive chamber 12 will also be gradually influenced by the interventional instrument 9. The location of the balancing hole 311 adjacent to the outlet of the interventional device 9 can accommodate the process of the interventional device 9 entering the adaptive hemostasis valve, and better reflect the dynamic changes of the fluid through the balancing hole 311 into the balancing chamber 31.

In a further refinement of the pressure regulation of the fluid, in one embodiment the balancing chamber 31 or the chamber wall of the drive chamber 12 is provided with a first pressure regulating bore 32.

The first pressure regulating hole 32 enables pressure regulation in the drive chamber 12 from the outside. In some use scenarios, an external pressure source may be provided to regulate the pressure of the fluid within the drive chamber 12. At the same time, the first pressure regulating bore 32 itself is also an interface, which can provide a structural basis for special operations in special use scenarios.

In one embodiment, the first pressure regulating hole 32 communicates with a first regulating valve (not shown);

the first regulating valve is directly installed in the first pressure regulating hole 32 or is communicated with the first pressure regulating hole 32 through an external pipe.

The flexible arrangement of the first regulating valve can be adjusted according to the use requirements of different cases. For example, the design that the first regulating valve is directly installed in the first pressure regulating hole 32 can improve the integration level of the self-adaptive hemostatic valve, and is convenient for operation of medical staff and other operators; further, for example, the first regulating valve is connected to the first pressure regulating hole 32 via an external pipe, so that the external dimension of the adaptive hemostatic valve can be further reduced, and the adaptive performance can be provided.

In a further refinement of the energy store 3, the energy store 3 comprises an energy store chamber 33 and an energy store element mounted in the energy store chamber 33, which stores or releases energy in response to a change in state of the sealing membrane 2 and, when releasing energy, drives the sealing membrane 2 to seal the instrument channel 11.

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

an energy storage chamber 33; a balance chamber 31 is also arranged in the shell 1, and the driving chamber 12 is communicated with the balance chamber 31;

a piston 34 sealingly sliding between the balance chamber 31 and the energy storage chamber 33;

an energy storage element, which is a compressible gas and/or an elastic member, located in the energy storage chamber 33 and interacting with the piston 34.

In the present embodiment, the change in position of the piston 34 achieves charging or discharging of the charging mechanism 3. During energy storage, energy is absorbed by the compressible gas and/or the elastic member 341, and during energy release, the compressible gas and/or the elastic member 341 performs work to achieve energy release. The energy storage chamber 33 is a functional expression of the energy storage mechanism 3 during energy storage, and during energy release, the energy storage element is in the energy storage chamber 33, and the actual function is energy release.

The piston 34 slides in a sealing way between the balance chamber 31 and the energy storage chamber 33, and the body of the piston 34 is actually the partition boundary of the balance chamber 31 and the energy storage chamber 33, so that the relative space between the balance chamber 31 and the energy storage chamber 33 is changed. 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 partial stored energy becomes the balance chamber 31 chamber. The sealing engagement of the piston 34 is in fact important when the adaptive hemostasis valve is not connected to an external pressure source in order to avoid fluid in the equilibrium chamber 31 (i.e., fluid in the actuation chamber 12) from entering the energy storage chamber 33. During some treatments, the energy storage mechanism 3 may be adjusted accordingly. In one embodiment, the wall of the energy storage chamber 33 is opened with a second pressure adjusting hole 331.

The second pressure regulating hole 331 can adjust the change of the stored energy of the energy storage mechanism 3, thereby carrying out fine adjustment according to different treatment processes and improving the adaptability of the self-adaptive hemostatic valve. Meanwhile, the second pressure adjusting hole 331 is also an interface, and can provide a structural basis for special operations in a special use scene.

In one embodiment, the instrument channel 11 has an inlet for the interventional instrument 9 at one end and an outlet for the interventional instrument 9 at the other end, and the equilibrium chamber 31 is adjacent to the outlet for the interventional instrument 9 and the energy storage chamber 33 is adjacent to the inlet for the interventional instrument 9 along the axial direction of the instrument channel 11.

The instrument channel 11 is a channel through which the interventional instrument 9 enters the adaptive hemostasis valve, and there may be a process in which the interventional instrument 9 first contacts a portion of the sealing membrane 2 during the process of entering the adaptive hemostasis valve by the interventional instrument 9. Accordingly, the fluid in the drive chamber 12 will also be gradually influenced by the interventional instrument 9. The balance chamber 31 is a structure directly communicated with the driving chamber 12, so that the balance chamber 31 is arranged at a position adjacent to the outlet of the interventional device 9, which can adapt to the process of the interventional device 9 entering the self-adaptive hemostatic valve, and better reflect the dynamic change of the fluid to the energy storage mechanism 3 through the balance chamber 31.

In one embodiment, the energy storage chamber 33 is open at a side facing away from the balance chamber 31 and is hermetically mounted with a third end cap 332, and the second pressure adjustment hole 331 is provided on the third end cap 332.

The third end cap 332 actually forms a side wall of the accumulator chamber 33 and is therefore critical to maintaining pressure within the accumulator chamber 33 when sealingly installed. Meanwhile, the second pressure adjusting hole 331 is formed in the third end cap 332, so that a hole is prevented from being formed in the energy storage chamber 33, the process difficulty is reduced, and the possibility of leakage is avoided.

In the detail of the arrangement of the second pressure adjusting hole 331, in an embodiment, the second pressure adjusting hole 331 is communicated with a second adjusting valve (not shown);

the second regulating valve is directly installed in the second pressure regulating hole 331 or is communicated with the second pressure regulating hole 331 through an external pipe.

The flexible arrangement of the second regulating valve can be adjusted according to the use requirements of different cases. For example, the design that the second regulating valve is directly installed in the second pressure regulating hole 331 can improve the integration level of the self-adaptive hemostatic valve, and is convenient for operation of medical staff and other operators; for another example, the design of the second regulating valve communicated with the second pressure regulating hole 331 through an external pipeline can further reduce the external dimension of the adaptive hemostatic valve, providing adaptability.

In the detailed structure of the energy storage chamber 33, in an embodiment, an adjusting member 342 abutting against the elastic member 341 is disposed in the energy storage chamber 33, and at least a portion of the adjusting member 342 is exposed to the energy storage chamber 33 as an adjusting operation portion 343.

The adjusting member 342 is used for adjusting parameters such as preload and rebound speed of the elastic member 341, so that an operator of a medical worker can adjust the parameters of the adaptive hemostatic valve to adapt to different treatment processes. The adjustment operation part 343 is exposed in the energy storage chamber 33 for convenient operation, thereby avoiding the disassembly of the self-adaptive hemostatic valve and realizing the fine adjustment in the treatment process. In the embodiment without the elastic member 341, the second pressure-regulating hole 331 communicating with the accumulator chamber 33 may also be considered as a modification of the regulating member 342.

In the assembly of the adjusting element 342, in one embodiment, the energy storage chamber 33 is open on the side facing away from the balancing chamber 31 and is sealingly mounted with a third end cap 332, on which third end cap 332 the adjusting element 342 is arranged.

The third end cap 332 is fixed to the housing 1, has high strength, and can bear the load of the elastic member 341 and facilitate adjustment and assembly.

In the specific component structure of the adjusting part 342, in an embodiment, the adjusting part 342 is an adjusting screw rod in threaded fit with the chamber wall of the energy storage chamber 33, the head of the adjusting screw rod is used as an adjusting operation part 343, and the end of the adjusting screw rod opposite to the head is in abutting fit with the elastic part 341.

The form of adjusting screw is simple reliable, and above all, the regulation precision is higher, makes things convenient for operating personnel such as medical personnel meticulous regulation self-adaptation hemostasis valve's working parameter. Meanwhile, the thread fit can conveniently realize the sealing fit on the premise of realizing the adjustment.

In a detailed arrangement of the piston 34, in one embodiment, the direction of movement of the piston 34 and the direction of extension of the instrument channel 11 are arranged parallel or at an angle to each other.

The piston 34 is used for conveying the pressure of the fluid into the energy storage mechanism 3, the arrangement of the moving direction does not influence the realization of the function of the piston 34, and more is the consideration of the overall layout structure of the adaptive hemostatic valve. In an actual product, it may be set as needed. For example, the design that the moving direction of the piston 34 and the extending direction of the instrument channel 11 are parallel to each other can obtain a more regular overall shape; a further example of a design in which the direction of movement of the piston 34 is arranged at an angle to the direction of extension of the instrument channel 11 enables a more compact and practical overall design to be achieved in some specifically desired products.

The energy storage mechanism 3 can also realize the working effect through other structures. In one embodiment, the energy storage element is an elastic bag disposed in or outside the energy storage chamber. In the figure, the function of the energy storage chamber is actually replaced by the balancing chamber 31. The elastic bag 35 can realize energy storage or energy release cooperatively, so that the energy storage or energy release of the energy storage skill is further improved.

Specifically, in one embodiment, the elastomeric bladder 35 is suspended within the balancing chamber 31 or is secured to a wall of the balancing chamber 31.

The energy storage and release of the elastic bag 35 is achieved by self-deformation. Thus, there are a variety of ways of securing.

For example, referring to fig. 5c, the elastic bag 35 is suspended in the balancing chamber 31, and may be designed in plural. This design allows for sufficient release of the deformation of elastomeric bladder 35, and the change in position of elastomeric bladder 35 provides a structural basis for exceptional functionality in some specific scenarios. For example, may indicate a change in density of the fluid within the balance chamber 31, etc. Where suspension is relative to immobilization, the particular location of the elastic bladder 35 within the accumulator chamber 33 needs to be more dependent on the density of the medium stored within the elastic bladder 35 and the density of the medium within the accumulator chamber 33.

Referring again to fig. 4a to 5b, for example, the elastic bladder 35 is fixed to the chamber wall of the balancing chamber 31. This design allows for positioning of the elastomeric bladder 35 to avoid damage to the elastomeric bladder 35 caused by the elastomeric bladder 35 and the balancing chamber 31 rubbing against each other during storage and transportation or use.

Referring to fig. 4a to 4c, in an embodiment, the elastic bag 35 is fixed to a chamber wall of the balance chamber 31, and a third pressure adjusting hole 351 communicating with the elastic bag 35 is formed on the chamber wall of the balance chamber 31.

The third pressure-adjusting hole 351 enables pressure adjustment inside the elastic bag 35 from the outside. In some use scenarios, an external pressure source may be provided to regulate the pressure of the fluid within elastomeric bladder 35. Meanwhile, the third pressure adjusting hole 351 is also an interface, and can provide structural foundation for special operation in a special use scene.

In one embodiment, the third pressure adjusting hole 351 is communicated with a third adjusting valve (not shown);

the third regulator valve is directly installed in the third pressure regulating hole 351 or communicates with the third pressure regulating hole 351 through an external pipe.

The flexible arrangement of the third regulating valve can be adjusted according to the use requirements of different cases. For example, the design that the third regulating valve is directly installed in the third pressure regulating hole 351 can improve the integration level of the self-adaptive hemostatic valve, and is convenient for operation of medical staff and other operators; for another example, the third regulating valve is communicated with the third pressure regulating hole 351 through an external pipeline, so that the external dimension of the self-adaptive hemostatic valve can be further reduced, and the adaptive performance can be provided.

In the specific structure of the elastic bag 35, in an embodiment, the elastic bag 35 is a hollow structure and is filled with gas, and the gas stores or releases energy.

Compared with other elastic design forms, the gas has the advantages of larger deformation amount, convenience for better energy storage or release, and capability of restraining the gas by the elastic bag 35, so that the risk of influencing interventional operation is reduced.

Accordingly, in one embodiment, the elastic bladder 35 is an elastic material that stores or releases energy through deformation of the elastic material.

The elastic bag 35 is made of elastic material, so that the influence of gas on the intervention operation can be avoided, and safer intervention operation guarantee is brought. More importantly, through the elasticity of the elastic bag, different technical effects from other schemes can be realized. For example, a release hole is formed in the shell, an elastic bag is covered on the release hole, and fluid enters the elastic bag under the extrusion of the sealing film and drives the elastic bag to deform and store energy; in the energy release stage, the elastic bag deforms to extrude the fluid inside back to the shell, and therefore energy release is achieved.

As exemplified above, in some cases, the energy storage element may be deformed when disposed within the energy storage chamber 33. The following several exemplary embodiments should therefore be understood as equivalents of the present application.

The shell is provided with a release hole, the release hole is covered with an elastic part, fluid enters the elastic bag under the extrusion of the sealing film and drives the elastic bag to deform and store energy, and the volume of the energy storage chamber is expanded by the elastic part in a state similar to a blowing balloon in life; in the energy release stage, the elastic bag deforms to extrude the fluid inside back to the shell, and therefore energy release is achieved. The energy storage element in this embodiment is located at the boundary of the energy storage chamber 33, and it can be understood that the energy storage element itself expands and enlarges the energy storage chamber during the energy storage process of the energy storage element.

The energy storage element is a tension spring and is arranged in a position which is marked as a balance chamber in the attached drawing, fluid enters the energy storage chamber under the extrusion of the sealing film and drives the tension spring to stretch and store energy, the balance chamber at the moment actually forms the concept of the energy storage chamber, and the judgment on the concept of the energy storage chamber is to be seen in an actual function. In some aspects, the energy storage chamber may be shared with the balancing chamber.

With reference to fig. 6a and 6b, the present application also discloses a catheter sheath comprising a tubular body 91 and an adaptive hemostatic valve in mutual butt communication, the adaptive hemostatic valve being according to the above technical solution.

The body 91 is inserted into the human body, the self-adaptive hemostatic valve seals the body, and the insertion device 9 enters the body 91 through the self-adaptive hemostatic valve, so that the insertion device enters the human body to implement the treatment process.

In one embodiment, the adaptive hemostatic valve is provided with a pipe joint connected with the pipe 91, the pipe joint is matched with the pipe 91 through a sealing piece, and the pipe joint is provided with a clamping structure for preventing the pipe 91 from being separated from the pipe joint. In this embodiment, the pipe joint is formed by extending the second end cap 15. Through the cooperation of block structure, can realize the fast assembly of body 91 and self-adaptation hemostasis valve, also can realize the separation under emergency.

In the operation of specific details, the head of body 91 is equipped with the development point, makes things convenient for medical personnel better completion operation process under medical equipment's help.

In the use process of the self-adaptive hemostatic valve, the butt-joint communicated pipe body and the self-adaptive hemostatic valve cooperatively form an instrument channel 11, wherein the pipe body can be integrated with end covers on two sides or arranged in a split mode. Each end cap extends away from the adaptive hemostasis valve, extending in the axial direction of the instrument channel 11, further wrapping the instrument channel 11 for passage of the interventional instrument 9.

In one embodiment, the interventional device sealing method is implemented according to the adaptive hemostatic valve of the above technical scheme. For details of the structure of the adaptive hemostatic valve, reference may be made to the description of the adaptive hemostatic valve above, and further description is omitted here.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application.

Claims

1. Self-adaptation hemostasis valve, including the casing and install in the casing and be the seal membrane of tubular structure, the inner chamber of tubular structure is as the apparatus passageway, be equipped with in the casing and be in the peripheral drive chamber that is used for filling fluid of seal membrane, its characterized in that, self-adaptation hemostasis valve still including can with the energy storage mechanism that the fluid linked mutually, energy storage mechanism is in corresponding energy storage or energy release when sealed membrane state changes, and order about when energy release the seal membrane is sealed to be closed the apparatus passageway.

2. The adaptive hemostasis valve of claim 1, wherein the adaptive hemostasis valve has an operating state in which the drive chamber is filled with a fluid, and an initial state in which the drive chamber is not filled with the fluid, the fluid being an incompressible liquid.

3. The adaptive hemostasis valve of claim 2, wherein the fluid is saline or water.

4. The adaptive hemostasis valve of claim 1, wherein the sealing membrane has a first state compressed by an interventional instrument to open an instrument channel, the stored energy mechanism being fluid driven to store energy;

5. The adaptive hemostasis valve of claim 4, wherein the housing is a rigid structure at least at a periphery of the drive chamber.

6. The adaptive hemostasis valve of claim 5, wherein the housing is a generally rigid structure.

7. The adaptive hemostasis valve of claim 6, wherein the housing is formed of a transparent material.

8. A catheter sheath comprising a tube in abutting communication with an adaptive hemostasis valve, wherein the adaptive hemostasis valve is in accordance with any one of claims 1 to 7.

9. The interventional instrument sealing method includes constructing an instrument channel with a deformable sealing film, and driving the sealing film to deform via fluid to seal the instrument channel.

10. The interventional instrument sealing method of claim 9, wherein the interventional instrument sealing method is performed using the adaptive hemostasis valve of any one of claims 1 to 7.