A sealing structure

Abstract

The embodiment of the present specification provides a sealing structure using a balloon sealing valve and an annular sealing valve in combination, applied to an interventional medical instrument. The internal passages of the balloon sealing valve and the annular sealing valve are in communication with each other and with the internal passage of the medical instrument. The balloon sealing valve is divided into two layers, the inner layer being a balloon and the outer layer being a pressure maintaining member. The balloon lumen is in communication with the outside through a balloon pressure maintaining member, and the balloon can be inflated inwards by injecting gas or liquid through the balloon pressure maintaining port. By adjusting the pressure, the internal passage of the medical instrument can be sealed when empty and when loaded. The annular sealing valve is mainly responsible for sealing the internal passage of the medical instrument when the medical assembly is loaded.

Description

TECHNICAL FIELD

[0001] The present specification relates to the field of medical devices, and in particular to a sealing structure applied to an interventional medical device. BACKGROUND

[0002] Valves are membranous structures that open and close within organs of humans or some animals. For example, each human heart has four valves, namely, the aortic valve, the pulmonary valve, the mitral valve, and the tricuspid valve. In a mitral valve and tricuspid valve regurgitation repair surgery, an interventional system through veins cannot rely on the higher pressure of the aorta to design a suitable one-way valve to achieve the effect of system sealing as the aorta system does, and poor sealing can easily lead to air embolism in the heart. During an interventional treatment surgery, the entire treatment system enters the blood vessels from the outside, so that the internal environment of the human body is connected with the outside atmosphere. If some gas enters the internal environment of the human body during the surgery, the blood circulation contains more gas, and some blood vessels or some tissues can be blocked, causing the blood to be unable to circulate normally, thereby forming an air embolism. If the air embolism occurs in some parts of the heart, it can cause a heart attack, which directly threatens life. Therefore, designing a suitable sealing structure is very important for preventing air embolism in the venous system. SUMMARY

[0003] One of the embodiments of the present specification provides a sealing structure applied to an interventional medical device, the sealing structure comprising: a balloon sealing valve and an annular sealing valve; the internal passages of the balloon sealing valve and the annular sealing valve are in communication with the internal passage of the medical device.

[0004] In some embodiments, the balloon sealing valve comprises a pressure maintaining piece and a balloon; the balloon is attached to the inner wall of the pressure maintaining piece; the sealing structure further comprises a balloon pressurizing port, the balloon pressurizing port is in communication with the inner cavity of the balloon; injecting gas or liquid through the balloon pressurizing port can make the balloon expand inward.

[0005] In some embodiments, the balloon is an integral annular balloon body.

[0006] In some embodiments, the pressure maintaining piece is a tapered columnar body with a smaller middle diameter and larger end diameters.

[0007] In some embodiments, the annular sealing valve comprises a sealing ring, the sealing ring has a mounting hole in the middle for a medical component to pass through.

[0008] In some embodiments, the annular sealing valve further comprises a circular sealing sheet; the middle of the circular sealing sheet is provided with a cutout; when the circular sealing sheet is not extruded by external force, the cutout is closed to form a seal; when the circular sealing sheet is extruded, the circular sealing sheet breaks at the cutout to allow the medical component to pass through; the sealing ring and the circular sealing sheet are attached front and back.

[0009] In some embodiments, the circular sealing sheet has a curved surface with a convex surface facing the sealing ring.

[0010] In some embodiments, the sealing structure further comprises a venting port; the venting port is in communication with the internal passage of the medical instrument; the venting port is used to inject liquid into the internal passage of the medical instrument and to exhaust gas in the medical instrument.

[0011] In some embodiments, the venting port is located at the front side of the balloon sealing valve; the annular sealing valve is located at the rear side of the balloon sealing valve.

[0012] In some embodiments, the front end of the sealing structure is provided with a sealing valve distal end cover, the rear end is provided with a sealing valve proximal end front cover and a sealing valve proximal end rear cover; the front and rear ends of the balloon sealing valve are connected with the sealing valve distal end cover and the sealing valve proximal end front cover respectively; the annular sealing valve is fixed and connected with the balloon sealing valve through the sealing valve proximal end front cover and the sealing valve proximal end rear cover.

[0013] In some embodiments, the front end of the sealing structure is connected with the medical pipeline through screw thread fitting.

[0014] One of the embodiments of the present specification provides an interventional medical instrument, comprising the sealing structure of any one of the above embodiments.

[0015] One of the embodiments of the present specification provides a method for using the sealing structure of any one of the above embodiments, the method comprising: when the medical instrument is in an empty state, injecting gas or liquid through the balloon pressurizing port to make the balloon inflate inward to form a pipeline seal, and injecting liquid through the venting port to exhaust the gas in the medical instrument; when the medical instrument is loaded with a medical component, first depressurizing the balloon through the balloon pressurizing port, the medical component contacts the annular sealing valve to form a pipeline seal, and then exhausts the gas through the venting port to exhaust the gas entering the medical instrument when the medical component is assembled. BRIEF DESCRIPTION OF DRAWINGS

[0016] The present specification will be further illustrated in the form of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not limiting, and in these embodiments, the same numbers represent the same structures, wherein:

[0017] Figure 1 is a structural schematic diagram of the sealing structure when the balloon is not pressurized according to some embodiments of the present specification;

[0018] Figure 2 is a structural schematic diagram of the sealing structure when the balloon is pressurized according to some embodiments of the present specification;

[0019] Figure 3 is an assembly view of the sealing structure according to some embodiments of the present specification;

[0020] Figure 4 is an exploded view of the sealing structure according to some embodiments of the present specification;

[0021] Figure 5 is a structural view of the sealing structure when loading a medical assembly according to some embodiments of the present specification;

[0022] Figure 6 is a structural view of the sealing structure according to some other embodiments of the present specification;

[0023] Figure 7 is a use state view of the sealing structure according to some embodiments of the present specification;

[0024] Figure 8 is a structural view of an interventional medical instrument according to some embodiments of the present specification;

[0025] Figure 9 is an exploded view of an interventional medical instrument according to some embodiments of the present specification.

[0026] In the drawings: 100, sealing structure, 1, balloon sealing valve, 11, pressure maintaining piece, 12, balloon, 13, sealing valve distal end cover, 14, sealing valve proximal end front cover, 15, sealing valve proximal end rear cover, 16, clamping groove; 2, annular sealing valve, 21, sealing ring, 211, mounting hole, 22, circular sealing sheet; 3, balloon pressurizing port; 4, emptying port; 200, medical assembly; 300, delivery pipeline; 400, operation handle. DETAILED DESCRIPTION

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present specification, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are only some examples or embodiments of the present specification, and for those skilled in the art, without paying creative labor, the present specification can also be applied to other similar scenarios according to these drawings. Unless it is obvious from the language environment or otherwise stated, the same reference numbers in the drawings represent the same structure or operation.

[0028] It should be understood that "mounting", "connecting", "connecting", "coupling" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, or it can be connected inside two elements. However, if other words can achieve the same purpose, the words can be replaced by other expressions.

[0029] As shown in the specification and claims, unless the context clearly indicates otherwise, the words "one", "a", "an", and / or "the" do not refer to the singular, but can include the plural, as well. Generally, the terms "comprising" and "including" merely indicate inclusion of the elements specifically identified, and do not constitute an exclusive list of elements that can be included. "Proximal" refers to the end of the device that is closer to the operator during use; "distal" refers to the end of the device that is further from the operator during use.

[0030] In mitral valve and tricuspid valve regurgitation repair surgery, the transvenous intervention system cannot rely on the higher pressure of the aorta to design a suitable one-way valve to achieve the effect of system sealing, unlike the aortic system. Designing a suitable sealing structure is very important to prevent venous gas embolism, which is a major adverse event in the clinical trial report disclosed by MitraClip. The sealing of the venous system faces some difficulties: 1) The average pressure of the venous system and left atrium is relatively low, 4-12mmHg; 2) The venous system and left atrium sometimes produce negative pressure, i.e. back suction phenomenon; 3) To carry out transvenous mitral valve or tricuspid valve repair, it is necessary to rely on multi-layer sheath to reach the target position, and the sealing between the multi-layer sheath is more difficult. Moreover, once leakage occurs, it will lead to adverse events in clinical practice, and may even have serious consequences. Therefore, designing a reasonable sealing structure for the venous system is crucial for the transfemoral repair system. In order to solve the sealing problem of the venous system, the embodiments of the present application provide a sealing structure to ensure the sealing of the interventional medical device system in the transcatheter mitral valve and tricuspid valve repair surgery.

[0031] The embodiments of the present specification provide a sealing structure using a balloon sealing valve and an annular sealing valve in combination, applied to an interventional medical instrument. The internal passages of the balloon sealing valve and the annular sealing valve are in communication with each other and with the internal passage of the medical instrument. The balloon sealing valve is divided into two layers, an inner layer being a balloon and an outer layer being a pressure maintaining member. The balloon lumen is in communication with the outside through a balloon pressurizing member, and the balloon can be inflated inward by injecting gas or liquid through the balloon pressurizing port. By adjusting the pressure, the internal passage of the medical instrument can be sealed when empty or when loaded. The annular sealing valve is mainly responsible for sealing the internal passage of the medical instrument when the medical assembly is loaded. The use of the sealing structure can effectively prevent gas from entering the system or the human body during mitral valve or tricuspid valve repair surgery, thereby causing gas embolism and other related adverse events.

[0032] The following will be combined with Figures 1-7 The sealing structure related to the embodiments of the present application will be described in detail. It should be noted that the following embodiments are only used to explain the present application and do not constitute a limitation on the present application.

[0033] In some embodiments, as shown in the accompanying Figures 1-3 A sealing structure 100 includes a balloon sealing valve 1 and an annular sealing valve 2. The balloon sealing valve is divided into two layers, an outer layer being a pressure maintaining member 11 and an inner layer being a balloon 12. The balloon 12 is a whole annular balloon body, which is fitted and installed in the inside of the pressure maintaining member 11. The front and rear ends of the balloon 12 are fixedly connected with the front and rear ends of the pressure maintaining member 11, respectively. In some embodiments, the inside of the pressure maintaining member 11 is designed with a clamping groove 16, and the two ends of the balloon 12 are embedded in the clamping groove 16 for fixation. The sealing structure 100 further includes a balloon pressurizing port 3. The balloon pressurizing port 3 is in communication with the inner lumen of the balloon 12, and the balloon 12 can be inflated inward by injecting gas or liquid through the balloon pressurizing port 3. The balloon 12 is inflated to a certain size, and the pressure maintaining member 11 is in a sealing state with the balloon 12. Figure 2The sealing structure 100 is in a state of sealing the internal channel of the medical instrument. The balloon pressurization port 3 can be a channel opened on the sidewall of the front end or the rear end of the pressure maintaining member 11, and is used to communicate the inner cavity of the balloon 12 with the outside. In some embodiments, the balloon 12 is a single-layer structure, and the inner cavity of the balloon 12 is the space between the balloon 12 and the pressure maintaining member 11. In some embodiments, the balloon 12 is a double-layer structure, wherein the outer layer of the balloon is always in contact with the inner wall of the pressure maintaining member 11, and the inner cavity of the balloon 12 is the space between the inner and outer layers of the balloon 12. In some embodiments, the balloon 12 can be a plurality of sub-balloons arranged in a ring-shaped capsule, and each capsule is connected or each capsule is provided with a balloon pressurization port for simultaneously pressurizing the plurality of capsules. The sealing performance of the balloon 12 is directly related to the size of the pressure, and higher pressure means better sealing performance, and the sealing structure 100 can withstand a higher pressure difference between the two ends of the medical instrument. The pressure difference here refers to the pressure difference between one end of the human body and one end of the outside atmosphere. Higher pressure puts higher requirements on the material of the balloon 12 and the pressure maintaining member 11, and in some embodiments, the material of the balloon 12 and the pressure maintaining member 11 can be adjusted according to the required pressure. In some embodiments, the pressure maintaining member 11 and the balloon 12 can both be made of an elastic material. The pressure maintaining member 11 and the balloon 12 made of an elastic material will have corresponding elastic deformation when pressurized through the balloon pressurization port 3, which can effectively avoid the problem of rupture caused by excessive pressure. In some embodiments, the material of the pressure maintaining member 11 can be thermoplastic polyurethane elastomer (TPU) or silicone. TPU is a kind of elastomer that can be plasticized by heating and dissolved by solvent, and has excellent comprehensive performance such as high strength, high toughness, wear resistance, oil resistance, good processing performance, and is widely used in national defense, medical treatment, food industry and other industries. Preferably, the material of the pressure maintaining member 11 can be TPU, which can withstand higher pressure due to its relative hardness compared to silicone. In some embodiments, the material of the balloon 12 can be PTFE, TPU or PEBAX. Poly tetra fluoroethylene (PTFE), commonly known as "plastic king", is a high molecular polymer polymerized by using tetrafluoroethylene as a monomer; this material has the characteristics of acid and alkali resistance, resistance to various organic solvents. Polyether block polyamide (PEBAX for short) is not only a material with many unique dynamic mechanical properties between thermoplastic plastics and rubbers, but also has excellent antistatic performance. Preferably, the material of the balloon 12 can be PEBAX. In some embodiments, the pressure maintaining member 11 and the balloon 12 can be made of the same elastic material, for example, both can be TPU.In some embodiments, the material of the pressure-holding member 11 can be harder than that of the balloon 12 (e.g., harder, less elastic, etc.) so that the pressure-holding member 11 can withstand higher pressure. This design ensures that the sealing structure 100 will not cause the pressure-holding member 11 to undergo large expansion deformation due to the pressure expansion deformation of the balloon 12.

[0034] In some embodiments, as shown in the appendix Figures 1-5 As shown, the pressure-holding component 11 is a tapered column with a smaller diameter in the middle and larger diameters at both ends. The smaller diameter in the middle can form a certain interference fit with the medical component 200 (such as an expansion sheath, loader, etc.) that passes through, so that when the balloon 12 is not pressurized, the pressure-holding component 11 alone can achieve a certain sealing effect. Therefore, the specific size of the middle diameter of the pressure-holding component 11 can be designed according to the outer diameter of the medical component 200 that needs to pass through, such as achieving an interference fit to provide a certain sealing effect while ensuring that the medical component 200 can smoothly pass through the sealing structure 100 for back-and-forth movement.

[0035] In some embodiments, as shown in the appendix Figures 1-5 As shown, the sealing structure 100 has a distal end cap 13 at its front end and a proximal end cap 14 and a proximal end cap 15 at its rear end. The distal end cap 13 and the proximal end cap 14 are connected to the front and rear ends of the balloon sealing valve 1, respectively. The annular sealing valve 2 is fixed to the balloon sealing valve 1 via the proximal end cap 14 and the proximal end cap 15. The sealing structure 100 also includes a vent 4, which communicates with the internal channel of the medical device and is used to inject liquid into the internal channel of the medical device and to expel gas from the medical device. In some embodiments, the vent 4 is located on the distal end cap 13 of the sealing valve. The vent 4 is located on the front side of the balloon sealing valve 1, and the annular sealing valve 2 is located on the rear side of the balloon sealing valve 1. When the medical device is loaded with the medical component 200, the rear annular sealing valve 2 forms a sealing effect with the medical component 200. Meanwhile, when the balloon 12 is not pressurized, the medical device is emptied through the vent 4. Due to the negative pressure formed at the front end, the middle waist of the waist-shaped pressure-holding component 11 continues to shrink downward, forming a tighter fit with the medical component 200 and increasing the sealing performance.

[0036] In some embodiments, the actual use method of the emptying operation in the empty state (e.g., the state of the medical instrument without loading the medical component) can be: slightly tilting the distal end of the medical instrument upward, and then injecting liquid into the internal channel of the medical instrument from the emptying port 4. Due to the smaller density of the gas, the injection of the liquid can force the gas to go upward, that is, the gas will be discharged from the distal end of the medical instrument. The injection of the liquid is continued until the liquid continuously leaks out of the distal end of the medical instrument, and it is generally considered that the emptying is completed at this time. In some embodiments, the injected liquid can be normal saline. In some embodiments, the injected liquid can be heparin water.

[0037] In some embodiments, as shown in FIG. 2, the annular sealing valve 2 comprises a sealing ring 21. A mounting hole 211 is formed in the middle of the sealing ring 21 for the medical component 200 to pass through. When the medical component 200 is loaded, the medical component 200 passes through the mounting hole 211, and the inner wall of the sealing ring 21 tightly fits on the outer wall of the medical component 200 to achieve 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 component 200 to be passed through. The specific shape of the sealing ring 21 can be variously designed according to actual conditions, which is not limited here. In some embodiments, the sealing ring 21 can be made of silicone material, which has good elasticity, good sealing effect, and long service life. Figures 1-5 In some embodiments, as shown in FIG. 2, the annular sealing valve 2 further comprises a circular sealing sheet 22, which is installed in front of and behind the sealing ring 21. The circular sealing sheet 22 is a complete circular sheet, and a cutout is formed in the middle. The cutout can be in a straight line shape or a cross shape. When the circular sealing sheet 22 is not extruded by external force, the cutout is closed to form a seal to achieve a sealing effect. When the circular sealing sheet 22 is extruded, the circular sealing sheet 22 breaks at the cutout to allow the medical component 200 to pass through. In some embodiments, the circular sealing sheet 22 is attached to the front end of the sealing ring 21 and is fixed between the sealing valve proximal end front cover 14 and the sealing valve proximal end rear cover 15. In some embodiments, the circular sealing sheet 22 has a certain curved radius, and the convex surface of the curved surface faces the sealing ring 21, so that the circular sealing sheet 22 is effectively attached to the sealing ring 21, ensuring that the cutout does not crack and ensuring the sealing effect in the empty state. In some embodiments, the sealing ring 21 has a mounting hole 211 formed in the middle, and the sealing ring 21 can be made of silicone material. The inner diameter of the mounting hole 211 is smaller than the outer diameter of the medical component 200 to be passed through. When the medical component 200 is loaded into the medical instrument and passes through the mounting hole 211 from the rear end to the front end, the mounting hole 211 automatically expands and tightly fits on the outer wall of the medical tissue, forming a further sealing effect.

[0038] Figure 6 In some embodiments, as shown in FIG. 2, the annular sealing valve 2 further comprises a circular sealing sheet 22, which is installed in front of and behind the sealing ring 21. The circular sealing sheet 22 is a complete circular sheet, and a cutout is formed in the middle. The cutout can be in a straight line shape or a cross shape. When the circular sealing sheet 22 is not extruded by external force, the cutout is closed to form a seal to achieve a sealing effect. When the circular sealing sheet 22 is extruded, the circular sealing sheet 22 breaks at the cutout to allow the medical component 200 to pass through. In some embodiments, the circular sealing sheet 22 is attached to the front end of the sealing ring 21 and is fixed between the sealing valve proximal end front cover 14 and the sealing valve proximal end rear cover 15. In some embodiments, the circular sealing sheet 22 has a certain curved radius, and the convex surface of the curved surface faces the sealing ring 21, so that the circular sealing sheet 22 is effectively attached to the sealing ring 21, ensuring that the cutout does not crack and ensuring the sealing effect in the empty state. In some embodiments, the sealing ring 21 has a mounting hole 211 formed in the middle, and the sealing ring 21 can be made of silicone material. The inner diameter of the mounting hole 211 is smaller than the outer diameter of the medical component 200 to be passed through. When the medical component 200 is loaded into the medical instrument and passes through the mounting hole 211 from the rear end to the front end, the mounting hole 211 automatically expands and tightly fits on the outer wall of the medical tissue, forming a further sealing effect.

[0039] ​When the circular sealing plate 22 is not compressed by external force and the incision closes to form a sealed state, the balloon 12 can be left completely unpressurized, or when the system is unloaded or the balloon is damaged and cannot be pressurized, the medical device can still maintain its sealing performance under the action of the circular sealing plate 22. In some embodiments, the circular sealing plate 22 may not be able to close completely after multiple loadings, thus failing to achieve a sealing effect. In this case, the balloon sealing valve can be pressurized through the pressurization port 3 to achieve a sealing effect when unloaded. Therefore, the balloon sealing valve 1 and the annular sealing valve 2 can serve as complementary sealing components to each other.

[0040] In some embodiments, the sealing structure 100 may not have a balloon 12, and the balloon sealing valve 1 may only have a pressure-holding component. The annular sealing valve 2 connected to its rear end includes a sealing ring 21 and a circular sealing plate 22. The circular sealing plate 22 is responsible for sealing in the no-load state, and the sealing ring 21 is responsible for sealing when the medical component 200 is loaded. In some embodiments, the sealing structure 100 may not have a balloon sealing valve.

[0041] In some embodiments, as shown in the appendix Figure 7 , 8 As shown in Figure 9, the sealing structure 100 is connected to the delivery pipeline 300 via the threads of the sealing valve distal end cap 13. A groove is provided at the threaded connection to accommodate the sealing ring. Through threaded engagement, tightening compresses the sealing ring at the front and rear ends, achieving a sealing effect. In some embodiments, threadlocking adhesive can be added to the threaded portion to achieve a greater sealing effect.

[0042] In some embodiments, as shown in the appendix Figure 7 , 8 As shown in Figures 9 and 1, an interventional medical device includes a sealing structure 100 according to any of the above embodiments, a medical component 200, a delivery line 300, and an operating handle 400. The sealing structure 100 is connected to the delivery line 300 via threads on the distal end cap 13 of the sealing valve, and threadlocker can be added to the threaded portion to achieve a greater sealing effect. The operating handle 400 is sleeved on the delivery line 300 and can be manipulated to move the delivery line 300 forward until its tip reaches the surgical position. The sealing structure 100 may be located at the rear end of the operating handle 400. In some embodiments, the interventional medical device may be an instrument for mitral or tricuspid regurgitation repair. In some embodiments, the interventional medical device may be a medical device for other interventional procedures.

[0043] A method of using the sealing structure 100 of any of the above embodiments, comprising: when the medical instrument is empty, inflating the balloon 12 by injecting gas or liquid through the balloon inflation port 3 to form a pipeline seal, and evacuating the gas in the medical instrument by injecting liquid through the evacuation port 4; when the medical instrument is loaded with the medical component 200, first deflating the balloon 12 by injecting gas through the balloon inflation port 3, and then forming a pipeline seal between the medical component 200 and the annular sealing valve 2, and again evacuating the gas in the medical instrument by injecting gas through the evacuation port 4.

[0044] A method of using the interventional medical instrument comprising the sealing structure 100 of any of the above embodiments in a mitral valve or tricuspid valve repair surgery, comprising some or all of the following steps:

[0045] 001) When the medical instrument is empty, inflating the balloon 12 by injecting gas or liquid through the balloon inflation port 3 to form a pipeline seal, and evacuating the gas in the medical instrument by injecting liquid through the evacuation port 4;

[0046] 002) After atrial septum puncture, an ultrasonic guide wire is left in the atrial septum; at this time, the gas in the medical instrument is further evacuated by injecting gas through the evacuation port 4;

[0047] 003) The dilating sheath is sleeved outside the ultrasonic guide wire, the front end of the dilating sheath is conveyed through the annular sealing valve 2 of the sealing structure 100 to form a sealed state, the balloon 12 is deflated, and the gas in the medical instrument is again evacuated by injecting gas through the evacuation port 4, and the gas in the pipeline of the medical instrument is evacuated when the dilating sheath is inserted;

[0048] 004) The dilating sheath slides along the ultrasonic guide wire and finally moves to the atrial septum hole for expansion, so that the delivery pipeline of the medical instrument can pass through the atrial septum hole;

[0049] 005) After the expansion is completed, the ultrasonic guide wire and the dilating sheath are withdrawn, and when the front end of the dilating sheath retreats to the front side of the annular sealing valve 2 of the sealing structure 100, the balloon 12 is again inflated to ensure that the internal passage of the medical instrument is sealed;

[0050] 006) After the ultrasonic guide wire and the dilating sheath are withdrawn, the loader wrapped with the clipper is conveyed through the annular sealing valve 2 of the sealing structure 100 to form a sealed state, the balloon 12 is deflated, and the gas in the medical instrument is again evacuated by injecting gas through the evacuation port 4, and the gas in the pipeline of the medical instrument is evacuated when the loader is assembled;

[0051] 007) The loader is moved again to the surgical position.

[0052] The beneficial effects brought by the embodiments of the present application can include but are not limited to: 1) using the sealing structure can effectively ensure that no gas enters the system or human body during mitral valve and tricuspid valve repair surgery, thereby causing gas embolism and other related adverse events; 2) the balloon of the balloon sealing valve can be adjusted in real time according to the requirements of the surgical process, so as to realize pressure sealing or pressure relief for the movement of the medical assembly before and after; 3) the balloon sealing valve and the annular sealing valve are combined, and when one of them is damaged, they can supplement each other as backup, ensuring the sealing effect of the medical device.

[0053] The foregoing detailed description has set forth various embodiments of the application via the use of specific terminology. As such, the application is not intended to be limited to the embodiments described herein, but rather is intended to be commensurate with the scope of the appended claims. It should be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions can be made to a specific environment. Such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure. In an embodiment that is purely exemplary rather than limiting, the present application is embodied in the following clauses:

[0054] Also, the present application has been described in relation to particular embodiments, which will be apparent to those of ordinary skill in the art given the context of this disclosure. The contents of this description are not to be construed as limiting the scope of the present application. Those skilled in the art will readily recognize a variety of means both of an application-specific nature, as well as an application-agnostic nature, by which the embodiments described herein are implemented. Indeed, the present application is in no way limited to the contexts of the embodiments described and illustrated herein, but rather extends to any other contexts of any kind, where the features described herein are implemented.

[0055] Similarly, it is to be noticed that the term "comprising", used in the description, should not be interpreted as being restricted to the means provided, since the specific embodiments could be unconditionally extended to any alternative, equivalent or similar means. The same applies to the term "comprising", which should not be interpreted as being restricted to the means provided, since the specific embodiments could be unconditionally extended to any alternative, equivalent or similar means. The same applies to the term "comprising", which should not be interpreted as being restricted to the means provided, since the specific embodiments could be unconditionally extended to any alternative, equivalent or similar means.

[0056] Finally, it is to be understood that the embodiments described on the present application serve the purpose of illustrating the principles of the present application. Other variations are possible and are within the scope of the present application. Thus, for example, an alternative arrangement of the embodiments of the present application could be considered as consistent with the teachings of the present application. Accordingly, the embodiments of the present application are not limited to the embodiments explicitly introduced and described in the present application.

Claims

1. A sealing structure for use in interventional medical devices, characterized in that, The sealing structure comprises a balloon sealing valve, an annular sealing valve, a balloon pressurizing port and a venting port; 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 venting port is in communication with the internal passage of the medical instrument; The balloon sealing valve comprises a balloon, and the balloon pressurizing port is in communication with the inner cavity of the balloon; The annular sealing valve comprises a sealing ring and a circular sealing sheet, and a cut is formed in the middle part of the circular sealing sheet; when the circular sealing sheet is not extruded by external force, the cut is closed to form a seal; when the circular sealing sheet is extruded, the circular sealing sheet is broken at the cut to allow the medical component to pass through; the sealing ring and the circular sealing sheet are attached to each other in front and back; wherein, The circular sealing sheet has a curved surface, and the convex surface of the curved surface faces the sealing ring, so that the circular sealing sheet is effectively attached to the sealing ring.

2. The seal structure of claim 1, wherein The balloon sealing valve further comprises a pressure maintaining member; the balloon is attached to the inner wall of the pressure maintaining member; the balloon is inflated inwards by injecting gas or liquid through the balloon pressurizing port.

3. The seal structure of claim 2, wherein The balloon is an integral annular balloon body.

4. The seal structure of claim 2, wherein The pressure maintaining member is a tapered columnar body with a small middle diameter and large diameters at both ends.

5. The seal structure of claim 1, wherein A mounting hole is formed in the middle part of the sealing ring for the medical component to pass through.

6. The seal structure of claim 1, wherein The venting port is used for injecting liquid into the internal passage of the medical instrument and discharging gas in the medical instrument.

7. The seal structure of claim 6, wherein The venting port is located at the front side of the balloon sealing valve; the annular sealing valve is located at the rear side of the balloon sealing valve.

8. The sealed structure of claim 1, wherein, The front end of the sealing structure is provided with a sealing valve distal end cover, the rear end is provided with a sealing valve proximal end front cover and a sealing valve proximal end rear cover; the front and rear ends of the balloon sealing valve are connected to the sealing valve distal end cover and the sealing valve proximal end front cover, respectively; the annular sealing valve is fixed by the sealing valve proximal end front cover and the sealing valve proximal end rear cover and connected to the balloon sealing valve.

9. The seal structure of claim 1, wherein The front end of the sealing structure is connected to the medical pipeline through threaded cooperation.

10. An interventional medical instrument, characterized by The sealing structure comprises a balloon sealing valve, an annular sealing valve, a balloon pressurizing port and a venting port; 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 venting port is in communication with the internal passage of the medical instrument; 11. A method of using the seal structure of any one of claims 1-9, wherein, The method comprises: When the medical instrument is in an empty state, the balloon is inflated inwards by injecting gas or liquid through the balloon pressurizing port to form a pipeline seal, and the gas in the medical instrument is discharged by injecting liquid into the venting port; After the front end of the expansion sheath passes through the annular sealing valve to form a sealed state, the balloon is depressurized, the gas in the medical instrument is discharged by pumping air through the venting port, and the gas entering the pipeline of the medical instrument when the expansion sheath is inserted is discharged; After the expansion is completed, when the front end of the expansion sheath retreats to the front side of the annular sealing valve, the balloon is pressurized again to ensure that the internal passage of the medical instrument remains sealed; When the medical instrument is loaded with a medical component, the balloon is first depressurized by the balloon pressurizing port, the medical component contacts the annular sealing valve to form a pipeline seal, and the gas entering the medical instrument when the medical component is assembled is discharged by pumping air through the venting port.

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