CN211835809U

CN211835809U - Feedback regulating type hemostatic valve and catheter sheath

Info

Publication number: CN211835809U
Application number: CN201922482020.8U
Authority: CN
Inventors: 王翔; 雷荣军; 龚全钢; 郭烽; 赵银涛
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: 2020-11-03
Anticipated expiration: 2029-12-31

Abstract

The application discloses feedback regulation formula hemostasis valve, catheter sheath, wherein the formula hemostasis valve of feedback regulation includes the casing and installs 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 the seal membrane periphery is used for filling fluidic drive chamber, the formula hemostasis valve of feedback regulation still includes booster mechanism for with blood pressure change feedback in the fluid. The technical scheme that this application discloses through the setting of booster mechanism, with blood pressure change feedback in the fluid to the airtight pressure of self-adaptation adjustment seal membrane improves the effect that sealed membrane closed the apparatus passageway when interveneeing the relative seal membrane motion process of apparatus, improves operating personnel's such as medical personnel's operation experience, provides stable treatment, improves treatment.

Description

Feedback regulating type hemostatic valve and catheter sheath

Technical Field

The application relates to the field of medical equipment, in particular to a feedback regulation type hemostatic valve and a catheter sheath.

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.

SUMMERY OF THE UTILITY MODEL

In order to solve the technical problem, the application discloses feedback regulation formula hemostasis valve, include 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 seal membrane periphery is used for filling fluidic drive chamber, feedback regulation formula hemostasis valve still includes booster mechanism for with blood pressure change feed back in the fluid.

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

Optionally, the supercharging mechanism includes a support body, two cylinder chambers with different cylinder diameters are arranged inside the support body, a sliding part is hermetically and slidably mounted in each cylinder chamber, and the sliding parts in the two cylinder chambers are mutually linked;

the input port is communicated with a first cylinder chamber with a larger cylinder diameter; the output port communicates with a second cylinder chamber having a smaller cylinder diameter.

Optionally, the two cylinder chambers are communicated with each other, a linkage chamber is located between the two sliding members at the communication position, and the two sliding members are linked with each other through a medium pressure in the common linkage chamber.

Optionally, the sliding part in the first cylinder chamber is a first sliding part, one side of the first sliding part is an input chamber communicated with the input port, and the other side of the first sliding part is the common linkage chamber;

the sliding part in the second cylinder chamber is a second sliding part, one side of the second sliding part is an output chamber communicated with the output port, and the other side of the second sliding part is the common linkage chamber.

Optionally, the two cylinder chambers are isolated from each other, the two sliding members are directly connected through a connecting member, and two ends of the connecting member hermetically penetrate through the cylinder chambers to be connected with the corresponding sliding members.

Optionally, the sliding part in the first cylinder chamber is a first sliding part, one side of the first sliding part is an input chamber communicated with the input port, and the other side of the first sliding part is a first linkage chamber;

the sliding part in the second cylinder chamber is a second sliding part, one side of the second sliding part is an output chamber communicated with the output port, and the other side of the second sliding part is a second linkage chamber;

and two ends of the connecting piece penetrate into each linkage chamber in a sealing manner and are connected with the corresponding sliding pieces.

Optionally, the feedback adjustment type hemostasis valve is provided with a blood pressure feedback hole which can be communicated with a blood vessel in a use state, and the blood pressure feedback hole is communicated with the input port through a feedback pipeline.

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

Optionally, the feedback adjustment type hemostasis valve is provided with an exhaust hole, and the exhaust hole and the blood pressure feedback hole are respectively configured.

Optionally, the feedback adjustment type hemostasis valve is provided with an exhaust hole, the exhaust hole is also used as the blood pressure feedback hole, the feedback pipeline is communicated with an exhaust bypass, and an exhaust valve is arranged on the exhaust bypass.

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

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

Optionally, the axes of the two cylinder chambers are parallel or diagonal or perpendicular.

Optionally, the output port of the boost mechanism is in communication with the drive chamber.

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

the two cylinder chambers are communicated with each other, a linkage chamber between the two sliding parts is arranged at the communication part, and the two sliding parts are mutually linked through the medium pressure in the linkage chamber.

Optionally, a fourth pressure adjusting hole communicated with the linkage chamber is formed in the chamber wall of the linkage chamber; and a fifth pressure adjusting hole communicated with the output port is formed in the wall of the cylinder chamber with the smaller cylinder diameter.

the two cylinder chambers are mutually isolated, the two sliding parts are directly connected through the connecting part, and two ends of the connecting part penetrate into the cylinder chambers in a sealing manner to be connected with the corresponding sliding parts.

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

a sixth pressure adjusting hole communicated to one side of the sliding member in the second cylinder chamber; and a seventh pressure adjusting hole communicated to the other side of the sliding member in the second cylinder chamber, and the output port is also communicated to the side.

Optionally, each pressure adjusting hole is communicated with an adjusting valve; each regulating valve is directly arranged in the corresponding pressure regulating hole or is communicated with the corresponding pressure regulating hole through an external pipeline.

Optionally, a balance chamber is further arranged in the housing, and the driving chamber and the balance chamber are communicated with each other;

the output port of the pressurization mechanism is communicated with the driving chamber and/or the balancing chamber.

Optionally, the feedback-adjusting hemostasis valve further comprises an energy storage mechanism which can be linked with the fluid, and the energy storage mechanism stores or releases energy correspondingly when the state of the sealing membrane changes so as to drive the sealing membrane to close the instrument channel;

the fluid in the driving chamber is linked with the energy storage mechanism through the balance chamber;

the output of the booster mechanism acts directly on the energy storage mechanism, or the output port of the booster mechanism communicates with the drive chamber and/or the balance chamber.

Optionally, the energy storage mechanism comprises an elastic bag disposed in the balancing chamber;

the output port of the pressurization mechanism communicates with the balance chamber.

the output port of the pressurization mechanism is communicated with the elastic bag.

Optionally, the energy storage mechanism includes:

the energy storage chamber is communicated with the balance chamber;

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

a compressible gas and/or resilient member within said energy storage chamber and interacting with said piston;

the output port of the pressurization mechanism is communicated with the energy storage chamber.

Optionally, the energy storage mechanism includes:

the energy storage chamber is communicated with the balance chamber;

Optionally, the blood pressure display device further comprises a blood pressure indicating device connected with the input port.

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

Optionally, the pressurizing mechanism is provided with at least a moving part related to blood pressure, and a blood pressure mark is arranged in the pressurizing mechanism and is related to the position of the moving part.

the moving part is a slide in the first cylinder chamber and/or a slide in the second cylinder chamber.

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

The application also discloses the conduit sheath, including body and the feedback regulation formula hemostasis valve of mutual butt joint intercommunication, the formula hemostasis valve of feedback regulation is one of above-mentioned technical scheme.

Optionally, be equipped with on the feedback regulation formula hemostasis valve with the coupling that the body is connected, the coupling pass through the sealing member with the body cooperation, just the coupling have prevent the body with the block structure of coupling separation.

The application also discloses an interventional device sealing method, which comprises the steps of constructing a device channel by using the deformable sealing membrane, driving the sealing membrane to deform by using fluid at the periphery of the sealing membrane so as to seal the device channel, and feeding back blood pressure change to the fluid by using a pressurizing mechanism in the process of entering and exiting the device channel of the interventional device so as to keep the sealing between the interventional device and the device channel.

Optionally, the interventional instrument sealing method is implemented by using a feedback regulation type hemostatic valve in the technical scheme.

The technical scheme that this application discloses through the setting of booster mechanism, with blood pressure change feedback in the fluid to the airtight pressure of self-adaptation adjustment seal membrane improves the effect that sealed membrane closed the apparatus passageway when interveneeing the relative seal membrane motion process of apparatus, improves operating personnel's such as medical personnel's operation experience, provides stable treatment, improves treatment.

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 hemostatic valve of FIG. 1a in a filled state;

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

FIG. 2 is a schematic view of another embodiment of a pressurization mechanism in one embodiment;

FIG. 3 is a schematic view of an alternative communication of the pressurization mechanism in one embodiment;

FIG. 4a is a schematic view of a pressurization mechanism disposed within a hemostasis valve in one embodiment;

FIG. 4b is a schematic view of another embodiment of the hemostatic valve of FIG. 4 a;

FIG. 5a is a schematic view of an embodiment of a hemostatic valve employing an alternative energy storage mechanism;

FIG. 5b is a schematic view of an alternative communication of the pressurization mechanism of the hemostatic valve of FIG. 5 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; 14. a blood pressure feedback port;

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

3. an energy storage mechanism; 31. a balancing chamber; 34. a piston; 35. an elastic bag; 33. an energy storage chamber;

4. a pressurization mechanism; 40. a support body; 401. a first cylinder chamber; 402. a second cylinder chamber; 41. an input port; 42. an output port; 43. a first slider; 431. an input chamber; 432. a connecting member; 44. a second slider; 441. an output chamber; 442. a common linkage chamber; 443. a first linkage chamber; 444. a second linkage chamber; 451. a fourth pressure regulating hole; 452. a fifth pressure regulating hole; 453. a sixth pressure regulating hole; 454. a seventh pressure regulating orifice;

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 1c, the application discloses a feedback regulation type hemostatic valve, which comprises 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 for filling fluid is arranged in the housing 1 and positioned at the periphery of the sealing membrane 2, and the feedback regulation type hemostatic valve further comprises a pressurizing mechanism 4 for feeding back blood pressure changes to the fluid.

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. In which the instrument channel 11 is open at both ends for the passage of instruments, so that the sealing of the sealing membrane 2 is referred to as 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 instrument passes through the housing 1, the instrument channel 11 needs to penetrate through the housing 1, and the actual length of the instrument channel 11 is greater than the effective length of the housing 1 in the length direction of the instrument 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.

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.

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 an instrument in the instrument channel 11, the sealing membrane 2 can either close the instrument channel 11 or open the instrument channel 11.

When the interventional instrument is in the instrument channel 11, the inner cavity 21 of the sealing membrane 2 is radially folded to cooperate with the instrument to close the instrument channel 11.

When the interventional instrument 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 pressurizing mechanism 4 in this embodiment adjusts the sealing effect of the instrument channel 11 by feeding back the blood pressure at one end of the feedback adjustment type hemostatic valve to the fluid to change the fluid pressure in the driving chamber 12 and further adjust the operating state of the sealing membrane 2. This design can improve the effect that 2 seal membrane 2 seal apparatus passageways 11 when intervene 9 relative seal membrane 2 motion processes, improves operating personnel's such as medical personnel's operation experience, provides stable treatment process, improves treatment.

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 a specific arrangement of the pressurizing mechanism 4, in an embodiment, the pressurizing mechanism 4 has an input port 41 for collecting blood pressure and a pressurized output port 42, and the output of the pressurizing mechanism 4 directly or indirectly acts on the fluid in the driving chamber 12.

The energy input of the increasing mechanism comes from the blood pressure and therefore requires a connection to be established with the inside of the body. In the use scene of the feedback regulation type hemostatic valve, the blood environment inside the human body is easily communicated. The pressurizing mechanism 4 can thus feed back the blood pressure change to the fluid through a simple communication relationship. In the feedback process, the booster mechanism 4 can be directly acted on the fluid or indirectly linked through transmission between components.

From the structural point of view of the increasing mechanism, in an embodiment, the supercharging mechanism 4 comprises a supporting body 40, two cylinder chambers with different cylinder diameters are arranged inside the supporting body 40, a sliding part is hermetically and slidably mounted in each cylinder chamber, and the sliding parts in the two cylinder chambers are mutually linked;

the input port 41 communicates with the first cylinder chamber 401 having a large cylinder diameter; the output port 42 communicates with the second cylinder chamber 402 having a smaller cylinder diameter.

The support body 40 provides a stable working environment, and the two cylinder chambers can restrict the working stroke of the respective slides. The sliding part realizes the energy transmission by acting with the fluid in the corresponding cylinder chamber. It should be noted that the expression that the cylinder diameter is larger and smaller in the first cylinder chamber 401 and the second cylinder chamber 402 with a smaller cylinder diameter means a result of comparison between the first cylinder chamber 401 and the second cylinder chamber 402. The same applies hereinafter.

The cylinder diameters of the two cylinder chambers are different, and the effect of pressure adjustment can be achieved. The feedback relationship between blood pressure and fluid is adjusted according to the needs of the actual product.

The linkage between the sliding parts in the two cylinder chambers can be realized in various forms, for example, in one embodiment, the sliding parts in the two cylinder chambers are connected through a solid part; further, for example, the interlocking is realized by filling a fluid, and in one embodiment, the two cylinder chambers are communicated with each other, and a communication portion is an interlocking chamber between the two sliding members, and the two sliding members are interlocked with each other by a medium pressure in the common interlocking chamber 442; the linkage is realized, for example, by an energy field or a force field, and in one embodiment, the sliding pieces in the two cylinder chambers are linked with each other by a magnetic field.

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

the second slider 44 is a slider in the second cylinder chamber 402, and one side of the second slider 44 is an output chamber 441 communicating with the output port 42, and the other side is a common linkage chamber 442.

The common linkage chamber 442 functions to provide a space for movement for the linkage relationship between the slides in the two cylinder chambers. During movement of the slides within the two cylinder chambers, changes may occur between the input chamber 431, the common linkage chamber 442, and the output chamber 441. For example, when the first slider 43 is driven by blood pressure to move toward the second slider 44, the portion originally belonging to the common linkage chamber 442 is compressed and becomes a space of the input chamber 431.

Common linkage chamber 442 may also be of varying design and converted to a separate linkage chamber. Referring to fig. 2, in an embodiment, the two cylinder chambers are isolated from each other, the two sliding members are directly connected by a connecting member 432, and both ends of the connecting member 432 are hermetically inserted into the respective cylinder chambers and connected to the corresponding sliding members.

In one embodiment, the sliding member in the first cylinder chamber 401 is a first sliding member 43, one side of the first sliding member 43 is an input chamber 431 communicated with the input port 41, and the other side is a first linkage chamber 443;

the sliding member in the second cylinder chamber 402 is a second sliding member 44, one side of the second sliding member 44 is an output chamber 441 communicated with the output port 42, and the other side is a second linkage chamber 444;

both ends of the connecting member 432 are sealingly penetrated into the respective interlocking chambers and connected to the corresponding sliding members.

The arrangement of the pressurizing mechanism 4 can be facilitated by the design mode of the split linkage chamber, so that a structural basis is provided for adjusting the integral shape of the feedback adjustment type hemostatic valve according to different treatment cases.

The energy source of the pressurizing mechanism 4 is from blood pressure, and in the setting of an input mode, in an embodiment, a blood pressure feedback hole 14 which can be communicated with a blood vessel in a use state is opened on a feedback regulation type hemostatic valve, and the blood pressure feedback hole 14 is communicated with the input port 41 through a feedback pipeline.

The blood pressure feedback hole 14 can realize the pressure transmission of the blood pressure to the pressurizing mechanism 4, thereby realizing the energy transmission of the blood pressure to the pressurizing mechanism 4.

In principle, the blood pressure feedback hole 14 should be designed on the side of the feedback regulation type hemostasis valve close to the human body to realize hemostasis while meeting the use requirement of the pressurization mechanism 4. Specifically, in one embodiment, the instrument channel 11 has an instrument inlet at one end and an instrument outlet at the other end, and the blood pressure feedback hole 14 is located adjacent to one side of the instrument outlet.

One side of the appliance outlet is closer to the human body, and the blood pressure feedback hole 14 is close to the appliance outlet so as to be convenient to establish connection with the blood of the human body. And can realize the energy transport of blood pressure and booster mechanism 4 through shorter pipeline, improve booster mechanism 4 work effect under the dynamic operating mode.

In one embodiment, the feedback-regulating hemostatic valve is provided with a vent (not shown) that is disposed separately from the blood pressure feedback port 14.

When medical instruments such as catheters entering the body and the like are used, the air in the instruments is generally required to be exhausted, and the air exhaust holes can overcome the problem that the instruments carry air before being used. At the same time, the operator can remove the gas inside the hemostatic valve by injecting saline into the vent 16 before use. Furthermore, the exhaust hole is an interface, and can provide a structural foundation for special operation in a special use scene. Whether the vent and the blood pressure feedback port 14 are separately configured has different advantages and limitations, and may be provided as desired. For example, the vent hole and the blood pressure feedback hole 14 are respectively configured to avoid the influence of the gas in the vent hole on the blood, thereby improving the safety. In some products, the vent and blood pressure feedback port 14 may also be configured together. In one embodiment, the feedback-adjusting hemostatic valve has an exhaust hole, which also serves as the blood pressure feedback hole 14, and the feedback line is connected to an exhaust bypass, which is provided with an exhaust valve.

The exhaust hole is also used as the blood pressure feedback hole 14, so that the component integration level of the feedback regulation type hemostatic valve can be improved, and the integral volume of the feedback regulation type hemostatic valve is ensured while the functions are increased. The exhaust gas from the exhaust valve can also be used for the pressurization mechanism 4 to achieve a better closing effect of the instrument channel 11. Accordingly, however, a check valve or the like is required to prevent the gas discharged from the discharge valve from affecting the blood in the human body.

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 can improve the integration level of the feedback regulation type hemostatic valve, and is convenient for operation of medical staff and other operators; further, the design of the vent valve in communication with the vent hole via an external conduit, for example, may further reduce the external dimensions of the feedback-regulated hemostatic valve, providing compliance.

In the mounting manner of the booster mechanism 4, in one embodiment, the support body 40 and the housing 1 are integrated or separated.

Referring to fig. 2, the support body 40 and the housing 1 in a split structure enable the flexible arrangement of the pressurizing mechanism 4 relative to the housing 1, so as to provide a more flexible feedback adjustment type hemostasis valve volume performance for an intervention site, and improve adaptability; referring to fig. 1a and 4a, the support body 40 and the housing 1 of an integrated structure can realize the integration of the pressurization mechanism 4 and the housing 1, reduce the arrangement of communicated pipelines and the like, facilitate the use feeling of medical staff and other operators, and reduce the links which may cause faults, especially the pipeline part with pressure.

In the internal set of details of the addition mechanism, in one embodiment, the two chambers are arranged coaxially, side-by-side, or nested inside-outside.

Different arrangements of the two cylinder chambers can bring about different technical effects. For example, two cylinder chambers which are coaxially arranged can facilitate the linkage arrangement between the two sliding parts, thereby reducing the production and assembly difficulty; for example, the two cylinder chambers arranged side by side can effectively control the length of the pressurizing mechanism 4 in the sliding direction of the sliding part, and the overall space performance of the feedback regulation type hemostatic valve is improved; for example, the two cylinder chambers which are arranged in an inner-outer nested manner can effectively control the sizes of the pressurizing mechanism 4 in the sliding direction of the sliding part and the radial direction of the sliding part, and further improve the overall space performance of the feedback regulation type hemostatic valve; the specific setting mode can be set according to different application scenes of the feedback regulation type hemostatic valve.

The arrangement of the two chambers is such that, in another dimension, in one embodiment, the axes of the two chambers are parallel or diagonal or perpendicular.

The two cylinder chambers are used for conveying the pressure of blood to fluid, the arrangement in the axial direction does not influence the realization of the functions of the two cylinder chambers, and more, the consideration of the overall layout structure of the feedback regulation type hemostatic valve is provided. In an actual product, it may be set as needed. For example, the axial directions of the two cylinder chambers are parallel to each other, so that a more regular overall shape can be obtained; further, for example, the oblique axial direction or the vertical arrangement of the two cylinder chambers enables a more compact and practical overall design to be realized in some special products.

Regardless of the arrangement of the two chambers, the final purpose of the pressurizing mechanism 4 is to deliver the pressure of the blood to the fluid, and in one embodiment, the output port 42 of the pressurizing mechanism 4 is in communication with the drive chamber 12.

The driving chamber 12 is a cavity for directly driving the sealing film 2 to deform, so that the communication between the output port 42 of the pressurizing mechanism 4 and the driving chamber 12 can directly react the blood pressure change to the fluid in the driving chamber 12, thereby bringing about more sensitive working effect.

Referring to fig. 4a and 4b, the pressurizing mechanism 4 can be integrated into the hemostatic valve, and the two sliding parts of the pressurizing mechanism 4 can be communicated with each other through the medium pressure between the two sliding parts, besides the mutual linkage of the two sliding parts through the connecting part 432. Specifically, in an embodiment, the supercharging mechanism 4 includes a support body 40, two cylinder chambers with different cylinder diameters are arranged inside the support body 40, a sliding part is hermetically and slidably mounted in each cylinder chamber, and the sliding parts in the two cylinder chambers are mutually linked;

the input port 41 communicates with the first cylinder chamber 401 having a large cylinder diameter; the output port 42 communicates with the second cylinder chamber 402 having a smaller cylinder diameter;

the two cylinder chambers are communicated with each other, a linkage chamber is arranged between the two sliding parts at the communication part, and the two sliding parts are mutually linked through medium pressure in the linkage chamber.

The two slides, linked by media pressure, can free the link 432 from physical size constraints, allowing for more flexible placement. More importantly, the pressure of the medium can be flexibly adjusted in the treatment process, thereby bringing about richer use methods.

In one embodiment, the wall of the linkage chamber is provided with a fourth pressure adjusting hole 451 communicated with the linkage chamber; a fifth pressure adjusting hole 452 is formed in the wall of the cylinder chamber having a smaller cylinder diameter so as to communicate with the output port 42.

The fourth pressure adjusting hole 451 can adjust the pressure of the medium in the interlocking chamber, thereby changing the interlocking relationship between the two sliders. For example, when the pressure of the medium in the linkage chamber is higher, the linkage relation between the two sliding parts is closer to the rigid transmission, and the pressurizing mechanism 4 has better dynamic response performance in scenes of higher blood pressure change speed or wider range and the like; for example, when the pressure of the medium in the linkage chamber is low, the linkage relationship between the two sliding parts is closer to the flexible transmission, and the motion energy of the two sliding parts and the like is absorbed by the medium in the linkage chamber, so that a more flexible working effect is provided for the pressurization mechanism 4.

The fifth pressure regulating aperture 452 is more direct than the fourth pressure regulating aperture 451 and is capable of directly regulating the pressure at the output port 42, thereby directly regulating the operation of the pressurizing mechanism 4 via an external pressure source and providing a greater variety of regulation options for the feedback regulating hemostatic valve.

Accordingly, the pressure adjustment hole may be provided in the booster mechanism 4 linked to the connecting member 432. In one embodiment, the supercharging mechanism 4 comprises a support body 40, two cylinder chambers with different cylinder diameters are arranged inside the support body 40, a sliding part is hermetically and slidably mounted in each cylinder chamber, and the sliding parts in the two cylinder chambers are mutually linked;

the two cylinder chambers are isolated from each other, the two sliding parts are directly connected through the connecting part 432, and two ends of the connecting part 432 penetrate through the cylinder chambers in a sealing manner to be connected with the corresponding sliding parts.

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

a sixth pressure regulation hole 453 communicating to one side of the slider in the second cylinder chamber 402; the seventh pressure adjusting hole 454 is communicated to the other side of the slider in the second cylinder chamber 402, and the output port 42 is also communicated to the side.

The sixth pressure regulating hole 453 regulates the pressure of the input port 41 and the seventh pressure regulating hole 454 regulates the pressure of the output port 42, which can lead to richer regulation options.

The fourth pressure regulation hole 451, the fifth pressure regulation hole 452, the sixth pressure regulation hole 453 and the seventh pressure regulation hole 454 are interfaces, and can provide structural foundation for special operation in a special use scene.

In one embodiment, each pressure adjusting hole is communicated with an adjusting valve; each regulating valve is directly arranged in the corresponding pressure regulating hole or is communicated with the corresponding pressure regulating hole through an external pipeline.

The flexible arrangement of the regulating valve can be adjusted according to the use requirements of different cases. For example, the design that the regulating valve is directly arranged in the pressure regulating hole can improve the integration level of the feedback regulating type hemostatic valve, and is convenient for operation of medical staff and other operators; further, for example, the design of the regulating valve communicated with the pressure regulating hole through an external pipeline can further reduce the external dimension of the feedback regulation type hemostatic valve and provide adaptability.

In one embodiment, a balance chamber 31 is further disposed in the housing 1, and the driving chamber 12 and the balance chamber 31 are communicated with each other;

the output port 42 of the pressurization mechanism 4 communicates with the drive chamber 12 and/or the equilibrium chamber 31.

The balance chamber 31 is a functional area division, and the balance chamber 31 can be communicated with the cavities of the driving chamber 12 which are independent from each other only through pipelines, or can share one solid cavity and have different functions.

In function of the balancing chamber 31, in one embodiment, the feedback-regulated hemostatic valve further includes an energy storage mechanism 3 operatively associated with the fluid, the energy storage mechanism 3 being adapted to store or release energy in response to a change in state of the sealing membrane 2 to urge the sealing membrane 2 to close the instrument channel 11;

the fluid in the driving chamber 12 is linked with the energy storage mechanism 3 through the balance chamber 31;

the output of the booster mechanism 4 acts directly on the energy storage mechanism 3, or the output port 42 of the booster mechanism 4 communicates with the drive chamber 12 and/or the equilibrium chamber 31.

The sealing membrane 2 is required to open the instrument channel 11 to avoid interference with the interventional instrument 9 as the interventional instrument 9 enters the feedback regulated 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 can extrude the sealing membrane 2 to open the device channel 11 by using a larger driving force, 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 is required to open the instrument channel 11 to avoid interference with the interventional instrument 9 as the interventional instrument 9 enters the feedback regulated 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 instrument 9 and provide good hand feeling for the entering process of the instrument; when the interventional instrument 9 exits the feedback-regulated hemostasis valve, the sealing membrane 2 needs to close the instrument channel 11 to function as a feedback-regulated 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 pressurization mechanism 4 is matched with the energy storage mechanism 3, so that the sealing effect of the instrument channel 11 and the use hand feeling when the interventional instrument 9 enters the feedback regulation type hemostatic valve can be further considered.

Referring to fig. 5a and 5b, in an embodiment, the energy storage mechanism 3 comprises an elastic bladder 35 disposed within the balancing chamber 31;

the output port 42 of the pressurization mechanism 4 communicates with the equilibrium chamber 31.

The elastic bag 35 can store or release energy, and the energy storage skill is improved. The outlet port 42 of the pressurization mechanism 4 communicates with the balancing chamber 31, and during the energy release, in addition to the elasticity of the sealing membrane 2 itself, the elastic bladder 35 and the pressurization mechanism 4 can work in cooperation to supplement the energy of the fluid. Other arrangements of the output port 42 of the charging mechanism 4 are possible, and in one embodiment, the energy storage mechanism 3 includes an elastic bladder 35 disposed in the balancing chamber 31; the output port 42 of the pressurizing mechanism 4 communicates with the elastic bag 35.

When the output port 42 of the booster mechanism 4 communicates with the elastic bag 35, the energy output from the booster mechanism 4 is released through the elastic bag 35. The elastic bag 35 is used as an energy storage component of the energy storage mechanism 3, and can buffer the energy released by the pressurization mechanism 4, so that a smoother performance is provided for the pressure change of the fluid, and the overall working effect of the feedback regulation type hemostatic valve is improved.

Correspondingly, the energy storage mechanism 3 can also be arranged in other ways. Referring to fig. 1a to 1c, in an embodiment, the energy storage mechanism 3 includes:

an energy storage chamber 33 communicating with the equilibrium chamber 31;

a piston 34 that slides in a sealed manner between the balance chamber 31 and the energy storage chamber 33;

a compressible gas and/or elastic member in the energy storage chamber 33 and interacting with the piston 34;

the output port 42 of the pressure increasing mechanism 4 communicates with the energy storage chamber 33.

In this embodiment, the supercharging mechanism 4 is actually shared with the energy storage mechanism 3 component structure, the linkage chamber functions as the energy storage chamber 33, and the second cylinder chamber 402 functions as the balance chamber 31. The change in position of the piston 34 effects the charging or discharging of the charging means 3. During energy storage, energy is absorbed by the compressible gas and/or the elastic member, and during energy release, the compressible gas and/or the elastic member perform work to realize 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 chamber 33 actually releases energy functionally.

The output port 42 of the booster mechanism 4 communicates with the accumulator chamber 33, and the energy output from the booster mechanism 4 is released by the piston 34 during the energy release. The piston 34 is able to buffer the energy released by the pressurizing mechanism 4, thereby providing a smoother behavior for the pressure variations of the fluid and improving the overall working effect of the feedback regulated hemostatic valve. There are other arrangements of the output port 42 of the booster mechanism 4,

referring to fig. 3, in an embodiment, the energy storage mechanism 3 includes:

an energy storage chamber 33 communicating with the equilibrium chamber 31;

The outlet port 42 of the pressurization mechanism 4 communicates with the balancing chamber 31, and during the energy release, in addition to the elasticity of the sealing membrane 2 itself, the elastic bladder 35 and the pressurization mechanism 4 can work in cooperation to supplement the energy of the fluid. The output effect of the booster mechanism 4 is more direct and is more suitable in some products requiring better dynamic performance.

The structure of the pressurizing mechanism 4 communicating with the blood of the human body can also provide a basis for other functions. In one embodiment, the feedback regulating hemostatic valve further comprises a blood pressure indicating device (not shown) connected to the input port 41.

Blood pressure is an important index in the treatment process, and compared with monitoring equipment which is provided with a sensor and an output device independently, the blood pressure indicating device realized by the supercharging mechanism 4 has the advantages of simple structure, stability, easy reading and convenient realization.

In the reading mode of the blood pressure indicating device, in an embodiment, the blood pressure indicating device is a separately configured sphygmomanometer or is integrated into the pressurizing mechanism 4.

In one embodiment, the pressurizing mechanism 4 has at least a moving part related to blood pressure, and a blood pressure indicator is provided in the pressurizing mechanism 4, and the blood pressure indicator is related to the position of the moving part.

In one embodiment, the supercharging mechanism 4 comprises a support body 40, two cylinder chambers with different cylinder diameters are arranged inside the support body 40, a sliding part is hermetically and slidably mounted in each cylinder chamber, and the sliding parts in the two cylinder chambers are mutually linked;

the moving parts are slides in the first cylinder chamber 401 and/or slides in the second cylinder chamber 402.

Referring to fig. 6a to 6b, the present application also discloses a catheter sheath, which comprises a tube 91 and a feedback-regulated hemostatic valve, wherein the tube 91 and the valve are in butt communication, and the feedback-regulated hemostatic valve is one of the technical solutions described above.

The body 91 is inserted into the human body, the hemostatic valve seals the body, and the insertion device 9 enters the body 91 through the feedback regulation type hemostatic valve, so as to enter the human body to implement the treatment process.

In one embodiment, the feedback regulation type 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 hemostatic 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 feedback regulation type hemostatic valve, the butt-joint communicated pipe body 91 and the hemostatic valve cooperatively form an instrument channel 11, wherein the pipe body 91 can be integrated with end covers on two sides or arranged in a split mode. Each end cap extends away from the haemostatic valve and thus extends in the axial direction of the instrument channel 11, further enclosing the instrument channel 11 for passage of the interventional instrument 9.

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.

In one embodiment, the interventional device sealing method is implemented according to the feedback-regulated hemostatic valve of the above-described aspects. For details of the structure of the hemostatic valve, reference may be made to the above description of the feedback-regulated hemostatic valve, which is not repeated herein.

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. Feedback regulation formula hemostasis valve, include 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 the fluid filling of seal membrane, its characterized in that, feedback regulation formula hemostasis valve still includes booster mechanism for with blood pressure change feedback in the fluid.

2. The feedback regulated hemostatic valve according to claim 1, wherein the pressurization mechanism has an input port for collecting blood pressure and a pressurized output port, the output of the pressurization mechanism acting directly or indirectly on the fluid within the drive chamber.

3. The feedback-regulated hemostatic valve according to claim 2, wherein the pressurizing mechanism comprises a support body, two cylinder chambers with different cylinder diameters are arranged inside the support body, a sliding member is hermetically and slidably mounted in each cylinder chamber, and the sliding members in the two cylinder chambers are mutually linked;

4. The feedback regulated hemostatic valve according to claim 3, wherein the two cylinder chambers are in communication with each other, and wherein the communication is a linkage chamber between the two slides, the two slides being in linkage with each other by a medium pressure in a common linkage chamber.

5. The feedback regulated hemostatic valve according to claim 4, wherein the slide in the first cylinder chamber is a first slide having an input chamber communicating with the input port on one side and the common linkage chamber on the other side;

6. The feedback regulated hemostatic valve according to claim 3, wherein the two chambers are isolated from each other and the two sliding members are directly connected by a connecting member, wherein the connecting member has two ends that sealingly penetrate each chamber and connect to the corresponding sliding member.

7. The feedback regulated hemostatic valve according to claim 6, wherein the first sliding member in the first cylinder chamber is a first sliding member having an input chamber on one side communicating with the input port and a first linkage chamber on the other side;

8. The feedback regulated hemostatic valve according to claim 2, further comprising a blood pressure indicating device connected to the input port.

9. A catheter sheath comprising a tube in abutting communication with a feedback-regulated hemostatic valve, wherein the feedback-regulated hemostatic valve is according to any one of claims 1 to 8.

10. The catheter sheath of claim 9, wherein the feedback control hemostasis valve is provided with a nipple connected to the tube, the nipple being engaged with the tube by a seal, and the nipple having a snap-fit feature preventing the tube from separating from the nipple.