CN114452049A

CN114452049A - Sealing structure

Info

Publication number: CN114452049A
Application number: CN202210245915.3A
Authority: CN
Inventors: 姚一心; 肖振昕; 虞奇峰; 秦涛
Original assignee: Shanghai Newpulse Medical Technology Co ltd
Current assignee: Shanghai Newpulse Medical Technology Co ltd
Priority date: 2022-03-14
Filing date: 2022-03-14
Publication date: 2022-05-10

Abstract

The embodiment of the specification provides a sealing structure for combining a balloon sealing valve and an annular sealing valve, which is applied to interventional medical equipment. The internal passages of the balloon sealing valve and the annular sealing valve are in communication with the internal passage of the medical instrument. The balloon sealing valve is divided into an inner layer and an outer layer, the inner side is a balloon, the outer side is a pressure maintaining piece, the inner cavity of the balloon is communicated with the outside through the balloon pressure maintaining piece, the balloon can be expanded inwards by injecting gas or liquid through the balloon pressure port, and the inner channel of the medical instrument can be in a sealing state during no-load and loading by adjusting the pressure. And the annular sealing valve is mainly used for sealing the internal channel of the medical instrument when the medical assembly is loaded.

Description

Sealing structure

Technical Field

The specification relates to the field of medical instruments, in particular to a sealing structure applied to an interventional medical instrument.

Background

Valves are membranous structures that can be opened and closed inside human or some animal organs. For example, each individual has four valves in the heart, namely the aortic, pulmonary, mitral and tricuspid valves. In mitral valve and tricuspid valve regurgitation repair operations, the transvenous intervention system can achieve the effect of system sealing by designing a proper one-way valve according to the higher pressure of the aorta unlike the aortic system, and the poor sealing can easily cause the occurrence of air embolism in the heart. When the interventional therapy operation, whole treatment system gets into the blood vessel from the outside for human internal environment can communicate with external atmosphere, if some gas gets into human internal environment in the operation process, leads to the gas in the blood circulation more, and certain blood vessel or some tissue can take place to block up, cause the unable normal circulation of blood, thereby form the air embolism. If the air embolism happens to some parts of the heart, the heart infarction can be caused, and the life is directly threatened. Therefore, designing a proper sealing structure is very important to prevent air embolism of the venous system.

Disclosure of Invention

One of the embodiments of the present specification provides a sealing structure, which is applied to an interventional medical instrument, and the sealing structure includes: a balloon seal valve and an annular seal valve; the internal channels of the balloon sealing valve and the annular sealing valve are in communication with the internal channel of the medical device.

In some embodiments, the balloon-sealed valve comprises a pressure retention member and a balloon; the balloon is attached to the inner wall of the pressure maintaining piece; the sealing structure further comprises a balloon pressurization port, and the balloon pressurization port is communicated with the inner cavity of the balloon; injecting gas or liquid through the balloon pressurization port may inflate the balloon medially.

In some embodiments, the balloon is a one-piece annular balloon.

In some embodiments, the retainers are waisted columns with a small diameter in the middle and a large diameter at the ends.

In some embodiments, the annular sealing valve comprises a sealing ring, and a mounting hole for passing the medical component is formed in the middle of the sealing ring.

In some embodiments, the annular sealing valve further comprises a circular sealing plate; the middle part of the circular sealing piece is provided with a notch; when the circular sealing sheet is not extruded by external force, the cut is closed to form a closed shape; when the circular sealing sheet is squeezed, the circular sealing sheet is broken at the cut to allow the medical assembly to pass through; the sealing ring and the circular sealing sheet are attached to each other in a front-back mode.

In some embodiments, the circular seal piece has a curvature with a convex surface facing the seal ring.

In some embodiments, the sealing structure further comprises a drain; the evacuation port is communicated with the internal channel of the medical instrument; the evacuation port is used for injecting liquid into the internal channel of the medical instrument and exhausting gas in the medical instrument.

In some embodiments, the drain is located on a front side of the balloon-sealed valve; the annular sealing valve is located on the rear side of the balloon sealing valve.

In some embodiments, the sealing structure is provided with a sealing valve distal end cover at the front end, and a sealing valve proximal end front cover and a sealing valve proximal end rear cover at the rear end; the front end and the rear end of the balloon sealing valve are respectively connected with a sealing valve distal end cover and a sealing valve proximal end front cover; the annular sealing valve is fixed by the sealing valve proximal end front cover and the sealing valve proximal end rear cover and is connected with the balloon sealing valve.

In some embodiments, the forward end of the sealing structure is connected to the medical tubing by a threaded fit.

One of the embodiments of the present disclosure provides an interventional medical device including a sealing structure according to any one of the embodiments.

One of the embodiments of the present specification provides a method for using the sealing structure according to any one of the above embodiments, where the method includes: when the medical instrument is in an idle state, injecting gas or liquid through the balloon pressurization port to enable the balloon to be inflated inwards to form a pipeline seal, and injecting liquid into the evacuation port to enable the gas in the medical instrument to be exhausted; when the medical component is loaded on the medical instrument, firstly, the balloon is decompressed through the balloon pressurization port, the medical component is in contact with the annular sealing valve to form a pipeline seal, and then the evacuation port is evacuated to evacuate air so as to discharge the gas entering the medical instrument when the medical component is assembled.

Drawings

The present description will be further explained by way of exemplary embodiments, which will be described in detail by way of the accompanying drawings. These embodiments are not intended to be limiting, and in these embodiments like numerals are used to indicate like structures, wherein:

FIG. 1 is a schematic structural view of a sealing structure of a balloon shown in accordance with some embodiments herein when not pressurized;

FIG. 2 is a schematic structural view of a sealing structure of a balloon when pressurized according to some embodiments of the present description;

FIG. 3 is an assembly schematic of a seal configuration according to some embodiments of the present description;

figure 4 is a schematic diagram of an exploded structure of a seal structure according to some embodiments of the present description;

FIG. 5 is a schematic structural view of a sealing structure when loading a medical assembly according to some embodiments of the present description;

FIG. 6 is a schematic structural view of a seal according to further embodiments of the present disclosure;

FIG. 7 is a schematic view of an application state of a seal structure according to some embodiments of the present description;

FIG. 8 is a schematic structural view of an interventional medical device according to some embodiments of the present description;

fig. 9 is a schematic diagram of an exploded structure of an interventional medical device, in accordance with some embodiments of the present description.

In the figure: 100. the sealing structure comprises a sealing structure 1, a balloon sealing valve 11, a pressure maintaining piece 12, a balloon 13, a sealing valve distal end cover 14, a sealing valve proximal end front cover 15, a sealing valve proximal end rear cover 16 and a clamping groove; 2. the sealing device comprises an annular sealing valve 21, a sealing ring 211, a mounting hole 22 and a circular sealing sheet; 3. a balloon pressurization port; 4. emptying the air; 200. a medical component; 300. a delivery line; 400. a handle is operated.

Detailed Description

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings used in the description of the embodiments will be briefly described below. It is obvious that the drawings in the following description are only examples or embodiments of the present description, and that for a person skilled in the art, the present description can also be applied to other similar scenarios on the basis of these drawings without inventive effort. Unless otherwise apparent from the context, or otherwise indicated, like reference numbers in the figures refer to the same structure or operation.

It should be understood that "mounted," "connected," and "coupled" are intended to be inclusive and may, for example, be fixedly connected, removably connected, or integrally connected; can be mechanically or electrically connected; either directly or indirectly through intervening media, or through the communication between two elements. However, other words may be substituted by other expressions if they accomplish the same purpose.

As used in this specification and the appended claims, the terms "a," "an," "the," and/or "the" are not intended to be inclusive in the singular, but rather are intended to be inclusive in the plural, unless the context clearly dictates otherwise. In general, the terms "comprises" and "comprising" merely indicate that steps and elements are included which are explicitly identified, that the steps and elements do not form an exclusive list, and that a method or apparatus may include other steps or elements. "rear end" and "proximal end" refer to the end that is closer to the operator of the medical device when in use; "front end" and "distal end" refer to the end that is distal to the operator of the medical device when in use.

In mitral and tricuspid regurgitation repair procedures, transvenous interventional systems, unlike the aortic system, can rely on the higher pressure of the aorta to design a suitable one-way valve to achieve the sealing effect of the system. Designing a proper seal is important to prevent air embolism in the venous system, which is also a major adverse event in the clinical trial report disclosed by MitraClip. Venous system sealing faces some of the following difficulties: 1) the average pressure of the venous system and the left atrium is lower, 4-12 mmHg; 2) the venous system and the left room sometimes generate negative pressure, namely, suck back phenomenon; 3) for the transvenous mitral valve or tricuspid valve repair, a target position must be reached by a plurality of layers of sheaths, the structure of the plurality of layers of sheaths is complex, and the difficulty of sealing between the sheaths is high. And once a leak occurs, adverse events can occur clinically, with potentially serious consequences. It follows that a reasonably designed sealing structure for the venous system is critical for a transfemoral repair system. To address the sealing problem of the venous system, embodiments of the present application provide a sealing structure that ensures the sealing of a medical device system inserted in a transcatheter mitral or tricuspid valve repair procedure.

The embodiment of the specification provides a sealing structure for combined use of a balloon sealing valve and an annular sealing valve, which is applied to interventional medical equipment. The internal passages of the balloon-sealing valve and the annular sealing valve are in communication with the internal passage of the medical instrument. The balloon sealing valve is divided into an inner layer and an outer layer, the inner side is a balloon, the outer side is a pressure maintaining part, the inner cavity of the balloon is communicated with the outside through the balloon pressure maintaining part, the balloon can be expanded inwards by injecting gas or liquid through a balloon pressure port, and the inner channel of the medical instrument can be in a sealing state during no-load and loading through adjusting the pressure. And the annular sealing valve is mainly used for sealing the internal channel of the medical instrument when the medical assembly is loaded. The sealing structure can effectively ensure that no gas enters a system or a human body in mitral valve and tricuspid valve repair operations to cause air embolism and other related adverse events.

The seal structure according to the embodiment of the present application will be described in detail below with reference to fig. 1 to 7. It should be noted that the following examples are only for explaining the present application and do not constitute a limitation to the present application.

In some embodiments, as shown in fig. 1-3, a sealing structure 100 includes a balloon-sealed valve 1 and an annular-sealed valve 2. The balloon sealing valve is divided into an inner layer and an outer layer, the outer side is provided with a pressure maintaining piece 11, and the inner side is provided with a balloon 12. The balloon 12 is an integral annular balloon that fits inside the retention member 11. The front end and the rear end of the balloon 12 are respectively fixedly connected with the front end and the rear end of the pressure maintaining piece 11. In some embodiments, the inner ends of the pressure retaining member 11 are designed with slots 16, and the two ends of the balloon 12 are inserted into the slots 16 for fixing. The sealing structure 100 also includes a balloon pressurization port 3. The balloon pressure port 3 communicates with the lumen of the balloon 12, and the balloon 12 is inflated inward by injecting gas or liquid through the balloon pressure port 3, and when the balloon 12 is inflated to the state shown in fig. 2, the balloon has an effect of sealing the internal passage of the medical device. The balloon pressurizing port 3 may be a passage provided in a side wall of the front or rear end of the pressure retaining member 11 for communicating the inner cavity of the balloon 12 with the outside. In some embodiments, the balloon 12 is a single layer structure and the lumen of the balloon 12 is the space between the balloon 12 and the retention member 11. In some embodiments, the balloon 12 has a double-layer structure, wherein the outer layer of the balloon is always attached to the inner wall of the pressure maintaining part 11, and the inner cavity of the balloon 12 is the space between the inner layer of the balloon 12 and the outer layer of the balloon. In some embodiments, the balloon 12 may be formed as a plurality of sub-balloons arranged in a toroidal shape, each balloon being in communication with another balloon, or each balloon may be provided with a balloon pressure port for simultaneously pressurizing a plurality of balloons. The sealing properties of the balloon 12 are directly related to the magnitude of the pressurization, with higher pressures meaning better sealing properties, and the sealing structure 100 being able to withstand higher pressure differentials across the medical device. The pressure difference here means a pressure difference existing between one end of the human body and one end of the external atmosphere. Higher pressures place higher demands on the material of the balloon 12 and the retaining member 11, and in some embodiments, the material of the balloon 12 and the retaining member 11 can be adjusted according to the pressure to be borne. In some embodiments, both the retention element 11 and the balloon 12 may be made of an elastic material. Adopt the pressurize piece 11 and the sacculus 12 of elastic material, when pressurizeing through sacculus pressurization mouth 3, pressurize piece 11 and sacculus 12 have corresponding elastic deformation, can effectively avoid because the too big cracked problem that leads to of pressure. In some embodiments, the material of the pressure retention member 11 may be thermoplastic polyurethane elastomer (TPU) or silicone. The TPU is an elastomer which can be plasticized by heating and can be dissolved by a solvent, has excellent comprehensive properties of high strength, high toughness, wear resistance, oil resistance and the like, has good processing performance, and is widely applied to the industries of national defense, medical treatment, food and the like. Preferably, the material of the pressure keeping member 11 may be TPU, which is harder than silicone and can bear higher pressure. In some embodiments, the material of the balloon 12 may be PTFE, TPU, or PEBAX. Polytetrafluoroethylene (PTFE, abbreviated as "plastic king"), is a high molecular polymer prepared by polymerizing tetrafluoroethylene as a monomer; the material has the characteristics of acid resistance, alkali resistance and resistance to various organic solvents. Polyether block polyamides (abbreviated as PEBAX) are not only materials with many unique dynamic mechanical properties between thermoplastics and rubbers, but also have excellent antistatic properties. Preferably, the material of the balloon 12 may be PEBAX. In some embodiments, the retention element 11 and the balloon 12 may be made of the same elastic material, for example, they may both be TPU. In some embodiments, the material of the retaining member 11 may be harder (e.g., harder, less elastic, etc.) than the material of the balloon 12, so that the retaining member 11 can withstand higher pressure, and the sealing structure 100 is designed such that the retaining member 11 does not have a larger expansion deformation due to the pressurized expansion deformation of the balloon 12.

In some embodiments, as shown in fig. 1-5, the retaining member 11 is a waisted cylinder with a small middle diameter and large ends, and the smaller middle diameter portion can form a certain interference fit with the passing medical components 200 (such as an expanding sheath, a loader, etc.), so that when the balloon 12 is not pressurized, a certain sealing effect can be achieved only by means of the retaining member 11. Therefore, the specific size of the intermediate diameter of the pressure maintaining member 11 can be designed according to the outer diameter of the medical assembly 200 to be passed through, such as to achieve a certain sealing effect by interference fit and ensure that the medical assembly 200 can smoothly pass through the sealing structure 100 to move back and forth.

In some embodiments, as shown in fig. 1-5, the sealing structure 100 has a sealing valve distal cover 13 at the front end and a sealing valve proximal front cover 14 and a sealing valve proximal back cover 15 at the back end. The front end and the rear end of the balloon sealing valve 1 are respectively connected with a sealing valve distal end cover 13 and a sealing valve proximal end front cover 14. The annular sealing valve 2 is fixed and connected to the balloon sealing valve 1 by a sealing valve proximal front cover 14 and a sealing valve proximal back cover 15. The sealing structure 100 further comprises a vent 4, wherein the vent 4 is communicated with the internal channel of the medical apparatus and is used for injecting liquid into the internal channel of the medical apparatus and exhausting gas in the medical apparatus. In some embodiments, the drain 4 opens on the sealing valve distal cap 13. The evacuation port 4 is located on the front side of the balloon-sealed valve 1, and the annular-shaped sealing valve 2 is located on the rear side of the balloon-sealed valve 1. The rear annular sealing valve 2 forms a sealing effect with the medical assembly 200 when the medical instrument is loaded with the medical assembly 200. Meanwhile, when the balloon 12 is not pressurized and the inside of the medical device is evacuated by the evacuation port 4, the waist part in the middle of the waist-shaped pressure retaining member 11 is continuously waisted down due to the negative pressure formed at the front end, and the waist part is in closer fit with the medical assembly 200, so that the sealing performance is improved.

In some embodiments, the method of actual use of the evacuation operation in an unloaded state (e.g., a state in which the medical device is not loaded with a medical component) may be: the distal end of the medical instrument is slightly inclined upwards, then liquid is injected into the internal channel of the medical instrument from the evacuation port 4, and due to the fact that the density of the gas is low, the gas can be forced to go upwards by the injection of the liquid, namely the gas can be exhausted from the distal end of the medical instrument, the liquid is continuously injected until the liquid seeps out from the distal end of the medical instrument continuously, and the evacuation is generally considered to be completed at the moment. In some embodiments, the injected liquid may be saline. In some embodiments, the injected liquid may be heparin water.

In some embodiments, as shown in fig. 1 to 5, the annular sealing valve 2 comprises a sealing ring 21, and a mounting hole 211 for passing the medical assembly 200 is opened in the middle of the sealing ring 21. When the medical module 200 is loaded, the medical module 200 passes through the mounting hole 211, and the inner wall of the sealing ring 21 is tightly attached to the outer wall of the medical module 200, thereby achieving a sealing effect. The inner diameter of the mounting hole 211 in the middle of the sealing ring 21 is slightly smaller than the outer diameter of the medical assembly 200 to be passed through. The specific shape of the sealing ring 21 may be designed according to actual conditions, and is not limited herein. In some embodiments, the sealing ring 21 may be made of a silicone material, which has good elasticity, good sealing effect, and long service life.

In some embodiments, as shown in fig. 6, the annular sealing valve 2 further includes a circular sealing piece 22, and the circular sealing piece 22 and the sealing ring 21 are attached to each other in a front-to-back manner. The circular sealing piece 22 is in a complete circular sheet shape, and a cut is formed in the middle of the circular sealing piece, wherein the cut can be in a straight shape or a cross shape. When the circular sealing piece 22 is not extruded by external force, the cut is closed to form a closed state, so that the sealing effect is realized; when the circular sealing piece 22 is squeezed, the circular sealing piece 22 breaks at the incision for the medical assembly 200 to pass through. In some embodiments, a circular sealing plate 22 fits over the front end of the sealing ring 21 while being fixed between the sealing valve proximal end front cover 14 and the sealing valve proximal end back cover 15. In some embodiments, the circular sealing piece 22 has a certain curvature, and the convex surface of the curvature faces the sealing ring 21, so that the circular sealing piece 22 is effectively attached to the sealing ring 21, the notch is prevented from cracking, and the sealing effect during no-load is ensured. In some embodiments, the middle of the sealing ring 21 is provided with a mounting hole 211, and the sealing ring 21 may be made of a silica gel material. The inner diameter of the mounting hole 211 is smaller than the outer diameter of the medical assembly 200 to be passed through, and when the medical assembly 200 is loaded on a medical instrument and passes through the mounting hole 211 from the rear end to the front end, the mounting hole 211 is automatically enlarged and tightly attached to the outer wall of the medical tissue, thereby further sealing effect is formed.

When the circular sealing sheet 22 is not squeezed by external force, and the cut is closed to be in a closed state, the balloon 12 can be selected not to be pressurized at all, or when the system is unloaded and the balloon is damaged and cannot be pressurized, the medical instrument can still ensure the sealing property under the action of the circular sealing sheet 22. In some embodiments, the circular sealing plate 22 may not be completely closed after multiple loads, and cannot perform a sealing function, and the balloon-sealing valve can perform a sealing function when the balloon-sealing valve is empty by being pressurized through the pressurization port 3. Thus, the balloon-sealed valve 1 and the annular-sealed valve 2 may act as complementary sealing members to each other.

In some embodiments, the sealing structure 100 may be without the balloon 12, the balloon-sealing valve 1 only having a pressure retaining member, and the rear-end connected annular sealing valve 2 comprising a sealing ring 21 and a circular sealing piece 22. The circular sealing disc 22 is responsible for sealing in the unloaded state and the sealing ring 21 is responsible for sealing when the medical assembly 200 is loaded. In some embodiments, the sealing structure 100 may be devoid of a balloon-sealed valve.

In some embodiments, as shown in fig. 7, 8 and 9, the sealing structure 100 is connected to the delivery line 300 by means of the screw thread of the sealing valve distal cap 13, and a groove is provided at the screw thread for placing a sealing ring. The sealing ring at the groove is extruded at the front end and the rear end of the screw after the screw is screwed down through screw thread fit, so that the sealing effect is achieved. In some embodiments, thread compound may be added to the threaded portion to achieve a greater sealing effect.

In some embodiments, as shown in fig. 7, 8 and 9, an interventional medical device includes the sealing structure 100 of any of the above embodiments, and a medical assembly 200, a delivery line 300 and an operating handle 400. The sealing structure 100 is connected to the delivery pipe 300 by means of the screw thread of the sealing valve distal cover 13, and a thread compound may be added to the screw thread portion to achieve a greater sealing effect. The operation handle 400 is installed on the delivery tube 300, and the delivery tube 300 can be operated to move forward until the front end of the delivery tube 300 reaches the surgical site. The sealing structure 100 may be provided at the rear end of the operating handle 400. In some embodiments, the interventional medical device may be a device for mitral or tricuspid regurgitation repair. In some embodiments, the interventional medical device may be a medical device used for other interventional procedures.

A method of using the sealing structure 100 of any of the above embodiments, the method comprising: when the medical appliance is in an idle state, gas or liquid is injected through the balloon pressurization port 3 to enable the balloon 12 to be inflated inwards to form pipeline sealing, and liquid is injected into the evacuation port 4 to enable the gas in the medical appliance to be evacuated; when the medical component 200 is loaded on the medical instrument, firstly, the balloon 12 is decompressed through the balloon pressurization port 3, the medical component 200 is contacted with the annular sealing valve 2 to form a pipeline seal, and then, the evacuation port 4 is evacuated to evacuate, so that the gas entering the medical instrument when the medical component 200 is assembled is exhausted.

A method of using an interventional medical device including a sealing structure 100 of any of the above embodiments in a mitral or tricuspid valve repair procedure, comprising some or all of the following steps:

001) when the medical instrument is in an idle state, injecting gas or liquid through the balloon pressurization port to enable the balloon to be inflated inwards to form pipeline sealing, and injecting liquid into the evacuation port to enable the gas in the medical instrument to be exhausted;

002) after the atrial septum is punctured, an ultrasonic guide wire is left in the atrial septum; at the moment, the air in the medical instrument is further exhausted by pumping the air exhausting port 4;

003) the expansion sheath is sleeved outside the ultrasonic guide wire in a sliding manner, the front end part of the expansion sheath is conveyed forwards to pass through the annular sealing valve 2 of the sealing structure 100 to form a sealing state, then the saccule 12 is decompressed, the air in the medical instrument is exhausted by pumping the evacuation port 4 again, and the air entering the pipeline of the medical instrument when the expansion sheath is inserted is exhausted;

004) the expansion sheath slides along the ultrasonic guide wire and finally moves to the interatrial septum hole for expansion, so that the delivery pipeline of the medical instrument can pass through the interatrial septum hole;

005) after the expansion is finished, the ultrasonic guide wire and the expansion sheath are withdrawn, and when the front end part of the expansion sheath is withdrawn to the front side of the annular sealing valve 2 of the sealing structure 100, the balloon 12 is pressurized again to ensure that the internal channel of the medical instrument keeps sealed;

006) after the ultrasonic guide wire and the expansion sheath are withdrawn, the loader wrapping the clamping device penetrates through the annular sealing valve 2 of the sealing structure 100 to form a sealing state, the balloon 12 is decompressed, the air in the medical instrument is exhausted by pumping the evacuation port 4 again, and the air entering the pipeline of the medical instrument when the loader is assembled is exhausted;

007) and then moving the loader to the surgical site.

The beneficial effects that may be brought by the embodiments of the present application include, but are not limited to: 1) the sealing structure can effectively ensure that no gas enters a system or a human body to cause air embolism and other related adverse events in mitral valve and tricuspid valve repair operations; 2) the balloon of the balloon sealing valve can adjust the pressure in real time according to the requirements of the operation process so as to realize pressurization sealing or pressure relief for the medical component to move back and forth; 3) the balloon sealing valve and the annular sealing valve are combined, and when one of the balloon sealing valve and the annular sealing valve is damaged, the balloon sealing valve and the annular sealing valve can be used as supplementary backup to each other, so that the sealing effect of the medical instrument is ensured.

Having thus described the basic concept, it will be apparent to those skilled in the art that the foregoing detailed disclosure is to be regarded as illustrative only and not as limiting the present specification. Various modifications, improvements and adaptations to the present description may occur to those skilled in the art, although not explicitly described herein. Such modifications, improvements and adaptations are proposed in the present specification and thus fall within the spirit and scope of the exemplary embodiments of the present specification.

Also, the description uses specific words to describe embodiments of the description. Reference throughout this specification to "one embodiment," "an embodiment," and/or "some embodiments" means that a particular feature, structure, or characteristic described in connection with at least one embodiment of the specification is included. Therefore, it is emphasized and should be appreciated that two or more references to "an embodiment" or "one embodiment" or "an alternative embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, certain features, structures, or characteristics may be combined as suitable in one or more embodiments of the specification.

Similarly, it should be noted that in the preceding description of embodiments of the present specification, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure aiding in the understanding of one or more of the embodiments. This method of disclosure, however, is not intended to imply that more features than are expressly recited in a claim. Indeed, the embodiments may be characterized as having less than all of the features of a single embodiment disclosed above.

Finally, it should be understood that the embodiments described herein are merely illustrative of the principles of the embodiments described herein. Other variations are also possible within the scope of the present description. Thus, by way of example, and not limitation, alternative configurations of the embodiments of the specification can be considered consistent with the teachings of the specification. Accordingly, the embodiments of the present description are not limited to only those embodiments explicitly described and depicted herein.

Claims

1. A sealing structure for use with an interventional medical device, the sealing structure comprising: a balloon seal valve and an annular seal valve; the internal channels of the balloon sealing valve and the annular sealing valve are in communication with the internal channel of the medical device.

2. The sealing structure of claim 1, wherein the balloon-sealed valve comprises a pressure retainer and a balloon; the balloon is attached to the inner wall of the pressure maintaining piece; the sealing structure further comprises a balloon pressurization port, and the balloon pressurization port is communicated with the inner cavity of the balloon; injecting gas or liquid through the balloon pressurization port may inflate the balloon medially.

3. The sealing structure of claim 2, wherein the balloon is a unitary annular bladder.

4. The seal of claim 2, wherein said retainer is in the form of a waisted column having a small diameter at its middle and a large diameter at its ends.

5. The sealing structure of claim 1, wherein the annular sealing valve comprises a sealing ring having a mounting hole defined therein for passage of a medical component therethrough.

6. The sealing structure of claim 5, wherein said annular sealing valve further comprises a circular sealing plate; the middle part of the circular sealing piece is provided with a notch; when the circular sealing sheet is not extruded by external force, the cut is closed to form a closed shape; when the circular sealing sheet is squeezed, the circular sealing sheet is broken at the cut to allow the medical assembly to pass through;

the sealing ring and the circular sealing sheet are attached to each other in a front-back mode.

7. The seal structure of claim 6, wherein the circular seal piece has a curvature with a convex surface facing the seal ring.

8. The seal structure of claim 1, further comprising a drain; the evacuation port is communicated with the internal channel of the medical instrument; the evacuation port is used for injecting liquid into the internal channel of the medical instrument and exhausting gas in the medical instrument.

9. The sealing structure of claim 8, wherein said evacuation port is located on a front side of said balloon-sealed valve; the annular sealing valve is located on the rear side of the balloon sealing valve.

10. The seal structure of claim 1, wherein the seal structure has a seal valve distal cover at a front end thereof and a seal valve proximal front cover and a seal valve proximal rear cover at a rear end thereof; the front end and the rear end of the balloon sealing valve are respectively connected with the sealing valve distal end cover and the sealing valve proximal end front cover; the annular sealing valve is fixed by the sealing valve proximal end front cover and the sealing valve proximal end rear cover and is connected with the balloon sealing valve.

11. The sealing structure of claim 1, wherein the forward end of the sealing structure is threadably engaged with a medical line.

12. An interventional medical device comprising a sealing structure according to any one of claims 1-11.

13. A method of using a sealing structure according to any of claims 1-11, the method comprising:

when the medical instrument is in an idle state, injecting gas or liquid through the balloon pressurization port to enable the balloon to be inflated inwards to form a pipeline seal, and injecting liquid into the evacuation port to enable the gas in the medical instrument to be exhausted;

when the medical component is loaded on the medical instrument, firstly, the balloon is decompressed through the balloon pressurization port, the medical component is in contact with the annular sealing valve to form a pipeline seal, and then the evacuation port is evacuated to evacuate air so as to discharge the gas entering the medical instrument when the medical component is assembled.