CN114129302A

CN114129302A - Valve clamp with sealing device

Info

Publication number: CN114129302A
Application number: CN202111395582.4A
Authority: CN
Inventors: 吴磊; 王陶; 赵月
Original assignee: Jenscare Scientific Co Ltd
Current assignee: Jenscare Scientific Co Ltd
Priority date: 2021-11-23
Filing date: 2021-11-23
Publication date: 2022-03-04

Abstract

The application relates to the field of medical equipment, in particular to a valve clamp with a sealing device, which comprises a clamping arm, a central rod and the sealing device, wherein the sealing device comprises a blocking piece and a traction piece; and the blocking member is a flexible member; blockking in this application and being flexible slice, and can attach well core rod when the pre-installation, neither can increase its pipe diameter of loading, can not influence the accent of transport apparatus in the blood vessel and bend the operation yet, when blood takes place palirrhea, blood strikes and stops to block and makes it bulge, block blood and flow to the atrium, and simultaneously, flexible blockking can not interfere the angle of opening of clamping arm when bulging, the technological pain point that exists has been solved again when possessing good leak protection effect among the prior art, and the clinical significance that has fine is good.

Description

Valve clamp with sealing device

Technical Field

The application relates to the field of medical equipment, in particular to a valve clamp with a sealing device.

Background

The mitral valve is located at the left atrioventricular orifice and is composed of five parts, an annulus, leaflets, chordae tendineae, papillary muscles, and an interfacing junction, which are anatomically known by the exact name mitral valve device (mitragrapparatus) or mitral valve complex (mitralcomplex).

The tricuspid valve is located at the right atrioventricular orifice and has three approximately triangular sail-like valves, the valve base of which is attached to the annulus fibrosus of the atrioventricular orifice, and the annulus fibrosus, valve, chordae tendineae and papillary muscles are functionally visualized as the tricuspid valvatomamplex.

Mitral regurgitation (mitralregorgement) can be classified into the following two categories: 1. the rheumatic mitral regurgitation of the heart, mainly caused by mitral insufficiency, can cause the blood to flow reversely, thus mixing different blood, causing the blood pumping and oxygen delivery functions of the heart to be reduced. 2. Non-rheumatic mitral regurgitation, in addition to rheumatic valvular lesions, is commonly referred to as mitral regurgitation to varying degrees due to abnormalities in the mitral valve itself and its surrounding anatomy. The causes of non-rheumatic mitral insufficiency are many, and the common causes are: mitral valve prolapse, papillary muscle insufficiency or chordae tendineae rupture, left atrial myxoma, calcification of the valve annulus, congenital valve malformations, infectious endocarditis, and the like. Mitral regurgitation can also be classified into three types, functional, degenerative or mixed. Most common are degenerative and functional mitral regurgitation. Functionality is typically secondary to impaired left ventricular wall motor function, left ventricular dilatation, papillary muscle dysfunction, commonly found in heart failure patients. This fraction also included ischemic mitral regurgitation secondary to coronary heart disease and mitral regurgitation associated with non-ischemic cardiomyopathy. Degenerative mitral regurgitation disease is generally considered to be a pathological change in the structure of the valve, or a pathological change in the structure under the valve, including abnormal extension or rupture of the chordae tendineae.

The regurgitation of the tricuspid valve is generally caused by pulmonary hypertension, right ventricle enlargement and tricuspid valve annulus expansion, and after the regurgitation of the tricuspid valve, the symptoms of right heart failure such as hypodynamia, ascites, edema, liver pain, dyspepsia, anorexia and the like are aggravated. Tricuspid insufficiency is largely classified into functional and organic tricuspid insufficiency. The valve insufficiency caused by rheumatic fever is very few in organic insufficiency and most in functional insufficiency, and the most common causes are right ventricle expansion caused by pulmonary hypertension and tricuspid annulus enlargement, which causes the relative insufficiency of the tricuspid valve and the normal structure of the valve. Such as rheumatic mitral valve disease, congenital cardiovascular disease, pulmonary heart disease, etc.

Conventional treatment for mitral and tricuspid valve regurgitation include medications for mild to severe regurgitation, and surgical procedures with corresponding surgical indications. Among the surgical methods are mitral valve, tricuspid valve replacement, and mitral valve and tricuspid valve repair. With pure mitral regurgitation, only 30% of patients need mitral valve replacement, and the rest only need mitral valve repair. In surgical procedures, typical open chest, open heart surgery is too invasive, requiring extracorporeal circulation to be established, with a high incidence of complications and risk of infection. In order to reduce the risk of surgery, transcatheter invasive replacement and repair surgical methods have been developed.

According to the literature [ Enriquez-SaranoM, SchaffHV, OrszolaktA, et al.Valverepari mprowestheoutcome of surgery for miralgoritation: amultivatorialysis [ J ] Circulation, 1995, 91 (4): 1022-1088 reports that replacement has a higher overall operative mortality and a lower survival rate. The problems to be solved at present in the transcatheter treatment of valve regurgitation include the following: the implantation amount of the implant is reduced on the premise of ensuring the reflux prevention effect as much as possible; the devices that block reflux must be accurately positioned and firmly secured at the site to be treated; instruments that block flow need to minimally affect the movement of the remaining leaflets with normal function; the apparatus for preventing regurgitation needs to adapt to the difference of the physiological structures of the valve annulus, and the technical points of different apparatuses for preventing regurgitation in the prior art are listed below.

Patent US16135920 provides an exemplary method of implanting a valve repair device on a patient's mitral valve by closing first and second claspers of the valve repair device to grasp leaflets of the mitral valve. The first and second leaflets of the valve repair device are closed to bring the leaflets of the mitral valve into contact with the coaptation or coaptation elements. In the scheme, the sealing device 510 is arranged between the first hasp and the second hasp and mainly plays a role in preventing blood backflow, but the sealing device 510 is large in size, so that the stroke of the repair device during conveying is long, blood vessels in a human body are tortuous, large-angle bending is needed particularly when an atrium enters a ventricle, tissues are easily scratched when the atrium bends due to the overlong stroke, and the patient is damaged and complications are caused.

Patent CN202022715441.3 discloses a valve clamp with a sealing function, which discloses an upper clamp assembly, a lower clamp assembly, a base, a locking mechanism, a link arm and a sealing mesh; the number of the upper clamp assemblies is equal to that of the lower clamp assemblies, and the upper clamp assemblies and the lower clamp assemblies are matched to form clamping parts. The lower part of the upper clamp assembly is fixedly arranged on one side surface of the locking mechanism, and the lower clamp assembly is movably connected to the locking mechanism and is positioned below the upper clamp assembly; the plugging netting is arranged on the other side surface of the locking mechanism, namely on the two side surfaces of the clamping part; when the upper clamping component and the lower clamping component are clamped, the plugging netting is in an open state to plug gaps on two sides of the clamping part. The technical scheme has the defects that: the submission of the plugging woven net is large, so that the diameter of a sheath tube of the valve clamping device is large when the valve clamping device is loaded, the requirement on the diameter of a transvascular instrument cannot be met, the large diameter of the vessel of a patient can be damaged, the plugging woven net is of a spherical structure, the plugging woven net cannot be recycled, the plugging woven net can influence the clamping length of valve leaflets, and the clamping of the valve leaflets is unstable.

In summary, the sealing device of the valve clip in the prior art has a series of problems of difficult instrument bending and the like due to overlarge volume, damage to blood vessels and overlong stroke.

Disclosure of Invention

The present application has been made in view of the above and other more general considerations.

One of the objectives of the present application is to overcome the deficiencies of the prior art, and to provide a valve clip with a sealing device, which is capable of solving the problems of the sealing device on the valve clip such as too large volume, damage to the blood vessel during the approach, and too long stroke, resulting in difficult bending of the device and interference with the opening and closing angle of the valve clip.

According to another aspect of the present application, there is provided a valve clip with a sealing device comprising a clipping arm, a central rod and a sealing device, the sealing device comprising a blocking member and a pulling member, the blocking member being disposed through the central rod, one end of the pulling member being connected to the blocking member, the other end of the pulling member being connected to the central rod, and the blocking member being a flexible member; the flexible blocking piece enables the valve clamp not to increase the loading pipe diameter during preassembling, and meanwhile, the bending operation of the conveying appliance during conveying cannot be influenced.

According to one embodiment, when the valve clip is preassembled, the blocking part is attached to the central rod, the loading radius of the valve clip cannot be increased, interference on bending of an apparatus or capturing of valve leaflets and the like cannot be caused, and when the valve clip is fixed with a native valve, the blocking part swells due to blood impact and blocks backflow of blood; when the valve is closed, part of blood passes through the valve clamp from the ventricle to flow back to the atrium, and the blocking piece is expanded by the impact of the blood and further prevents the blood from flowing to the atrium, so that the effects of sealing and preventing the backflow are achieved.

According to an embodiment, the blocking piece is of a sheet structure in a natural state, the influence of the blocking piece of the sheet structure on the loading pipe diameter is extremely small, when the blocking piece swells, the blocking piece is of an umbrella structure in general, and the blocking piece can effectively hold blood and prevent the blood from further moving to the atrium after swelling, so that a good backflow prevention effect is achieved.

According to one embodiment, when the blocking member is bulged, at least a part of the blocking member contacts or fits the clamping arm; the baffle piece with the flexible and sheet structure can adjust the size of the umbrella in real time according to the angle between the clamping arms, has good anti-backflow effect, cannot interfere the opening angle of the clamping arms, and has good clinical significance.

According to one embodiment, the periphery of the blocking member is provided with a skirt which is perpendicular to the central rod in a natural state; the setting of shirt rim can make and stop the piece and swell immediately when receiving blood impact, avoids blood to take place to stop the piece and still paste on well core pole when palirrhea.

According to an embodiment, the pull member is a flexible wire or thread and the pull member is folded between the clamping arm and the central rod when pre-assembled.

According to one embodiment, the distal end of the central rod is provided with a mounting slot, and the pulling element is placed in the mounting slot when pre-assembled.

According to one embodiment, the pulling element may be one or more.

According to an embodiment, the pull member is a rigid rod, the pull member engages the central rod when the valve clip is pre-assembled, and the pull member opens and forms an angle with the central rod when the blocking member is impacted by blood.

According to one embodiment, the barrier is made of a polymeric material, such as a PTFE material.

According to an embodiment, the diameter of the blocking member is greater than or equal to the diameter of the clamping arms at the maximum opening angle; the purpose of this design is: the valve clip can be completely covered after the blocking piece is bulged, and good anti-backflow effect is ensured.

According to an embodiment, the stop is connected to the central rod at a location that is less than one-half the length of the central rod from the proximal end of the central rod.

According to another embodiment, a valve clip with a sealing device comprises a clipping arm, a leaflet capturing spring, a central rod and a sealing device, wherein the sealing device is arranged on the central rod in a penetrating way, the sealing device is connected with the leaflet capturing spring, the sealing device is a flexible element, and the sealing device is of a generally sheet-shaped structure in a natural state and can be inflated to be of a generally umbrella-shaped structure after being impacted by blood.

Compared with the prior art, the technical scheme of the application has the advantages that at least the following steps are included:

in the prior art, the sealing device on the valve clip has larger volume, can increase the loading pipe diameter during loading, influence the bending operation of a conveying appliance entering the blood vessel and the like, and can generate interference by the opening angle of a clamping arm; according to an idea of the application, it is flexible piece to stop, and can attach well core rod when the pre-installation, neither can increase its pipe diameter of loading, can not influence the accent of transport apparatus in the blood vessel and bend the operation yet, when blood takes place palirrhea, blood strikes and stops to block that it makes it to swell, block blood and flow in the atrium, and simultaneously, flexible piece can not interfere the angle that opens of clamping arm when swelling, the technological pain point that exists has been solved again when possessing good leak protection effect among the prior art, and the clinical meaning that has is fine.

According to one concept of the application, the barrier piece can be bulged and is in an umbrella-shaped structure after being impacted by blood, the blood can be effectively taken up and prevented from further flowing into the atrium, and the backflow prevention effect is obvious.

According to one concept of the application, the diameter of the blocking piece is larger than or equal to the diameter of the clamping arm at the maximum opening angle; the purpose of this design is: the valve clip can be completely covered after the blocking piece is bulged, and good anti-backflow effect is ensured.

According to one concept of the application, the pull member prevents the blocking member from reversing direction, so that the blocking member can maintain an umbrella shape when being impacted by blood.

Embodiments of the present application are capable of achieving other advantageous technical effects not listed individually, which other technical effects may be described in part below and are anticipated and understood by those of ordinary skill in the art upon reading the present application.

Drawings

The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:

fig. 1 is a schematic view of the overall structure of the sealing device of the present invention.

Fig. 2 a-2 c are schematic views of the configuration of the fish blocking member in the pre-loaded and released states, respectively, of the sealing device of the present invention.

Figures 3a and 3b are schematic views of the delivery catheter of the present invention entering the heart from the inferior vena cava and then passing through the interatrial septum until it is positioned against the mitral valve.

Fig. 4 a-4 d are schematic views illustrating the operation process of repairing a mitral valve according to the present invention.

Fig. 5a to 5d show another embodiment of the sealing device according to the invention.

The figures in the drawings refer to the following features:

1-clamping arm, 2-center rod, 21-mounting groove, 3-sealing device, 31-blocking piece, 311-skirt edge, 32-pulling piece, 4-conveying conduit, 5-control handle and 6-valve leaf catching elastic piece.

Detailed Description

The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.

It is to be understood that the embodiments illustrated and described are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The illustrated embodiments are capable of other embodiments and of being practiced or of being carried out in various ways. Examples are provided by way of explanation of the disclosed embodiments, not limitation. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present application without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Accordingly, the disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

The present application will be described in more detail below with reference to various embodiments and examples of several aspects of the application.

In this application, the term "proximal" or "proximal" refers to the end or side closer to the operator, and "distal" or "distal" refers to the end or side farther from the operator.

One of the objects of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems.

Example one

As shown in fig. 1, a sealing device 3 on a valve clip according to an embodiment of the present application is illustrated, including a clipping arm 1, a central rod 2 and a sealing device 3, the sealing device 3 includes a blocking member 31 and a pulling member 32, the blocking member 31 is disposed on the central rod 2, one end of the pulling member 32 is connected to the blocking member 31, the other end of the pulling member 32 is connected to the central rod 2, the pulling member 32 can prevent the blocking member 31 from reversely overturning, and the blocking member 31 is a flexible member; the flexible blocking member 31 prevents the loading tube diameter of the valve clamp from being increased during preassembly, and meanwhile, the bending operation of the delivery instrument during delivery is not influenced.

In the first embodiment, when the valve clip is preassembled, the blocking member 31 is attached to the central rod 2, so that the loading radius of the valve clip is not increased, as shown in fig. 2a, and interference on bending of the device or capturing of valve leaflets and the like is not generated, and when the valve clip is fixed to the native valve, the blocking member 31 is swollen due to blood impact and blocks backflow of blood; when the valve is closed, part of the blood flows back from the ventricle through the valve clamp to the atrium, and at this time, the blocking member 31 is impacted by the blood to swell and further prevent the blood from flowing to the atrium, so as to achieve the effects of sealing and preventing the regurgitation, as shown in fig. 2 b.

In the first embodiment, the blocking member 31 is substantially in a sheet structure in a natural state, the influence of the blocking member 31 in the sheet structure on the loading pipe diameter is very small, when the blocking member 31 swells, the blocking member 31 is substantially in an umbrella structure, and the swelling of the blocking member 31 can effectively capture blood and prevent the blood from further moving towards the atrium, so as to achieve a good anti-regurgitation effect, as shown in fig. 2b and 2 c.

In the first embodiment, after the blocking member 31 swells, at least a part of the blocking member 31 contacts or fits the clamping arm 1; the blocking piece 31 which is flexible and has a sheet structure can adjust the size of the umbrella in real time according to the angle between the clamping arms 1, has good anti-backflow effect, cannot interfere the opening angle of the clamping arms 1, and has good clinical significance.

In the first embodiment, a skirt 311 is disposed on the periphery of the blocking member 31, and the skirt 311 is perpendicular to the central rod 2 in a natural state; the skirt 311 is arranged so that the barrier member 31 bulges immediately upon impact with blood, preventing the barrier member 31 from sticking to the center rod 2 during flashback of blood.

In this embodiment, the pulling element 32 is a flexible wire or thread, and the pulling element 32 is folded between the clamping arm 1 and the central rod 2 during pre-assembly, and the distal end of the central rod 2 is provided with a mounting groove, and the pulling element 32 is placed in the mounting groove during pre-assembly.

In the first embodiment, the blocking member 31 is made of a polymer material, for example, a PTFE material.

In the first embodiment, the diameter of the blocking member 31 is greater than or equal to the diameter of the clamping arm 1 at the maximum opening angle; the purpose of this design is: the blocking piece 31 can be ensured to completely cover the valve clamp after being swelled, and good anti-backflow effect is ensured.

In the first embodiment, the device further comprises a control handle 5 for delivering the valve clip and a delivery catheter 4.

An exemplary procedure for repairing a mitral valve using the sealing device 3 of a valve clip of the first embodiment is as follows:

1. operating the valve clip delivery catheter 4 from the inferior vena cava into the heart, and subsequently operating the delivery catheter 4 such that the valve clip passes through the atrial septum; continuing to operate the delivery catheter 4 to bend such that the valve clip is facing the mitral valve, as shown in figures 3a and 3 b;

2. operating the control handle 5 to enable the valve clip to penetrate through the mitral valve, judging whether the valve clip is located at the optimal valve clamping position through images and clamping the autologous valve leaflets, and finally fixing the valve clip and the autologous valve, as shown in fig. 4a and 4 b;

3. when the valve is closed, part of the blood flows from the left ventricle through the valve clamp into the left atrium, and the blocking member 31 is impacted by the blood to bulge out into an umbrella-shaped structure and pocket the blood in the umbrella, so that the blood is prevented from further flowing into the atrium, and a good anti-backflow effect is achieved, as shown in fig. 4c and 4 d.

Example two

The second embodiment is substantially the same as the first embodiment, except that the sealing device 3 in this embodiment is not provided with a pulling element 32, but the sealing device 3 is fixed to the leaflet catching spring 6.

In the second embodiment, a valve clip with a sealing device 3 comprises a clipping arm 1, a leaflet capturing elastic sheet 6, a central rod 2 and the sealing device 3, wherein the sealing device 3 is arranged on the central rod 2 in a penetrating manner, the sealing device 3 is connected with the leaflet capturing elastic sheet 6, as shown in fig. 5a and 5b, the sealing device 3 is a flexible member, the sealing device 3 is substantially in a sheet structure in a natural state, and the sealing device 3 is inflated and substantially in an umbrella structure after being impacted by blood.

In the second embodiment, the sealing device 3 is folded between the central rod 2 and the leaflet capturing spring 6 during pre-assembly, and since the sealing device 3 is a flexible sheet-like member, the diameter of the loading tube of the delivery catheter 4 will not be increased after folding, and there is no interference with the bending operation of the delivery device, and when there is regurgitation of the valve, the sealing device 3 will be inflated and assume an umbrella-like structure, so as to trap blood and prevent further flow into the atrium, as shown in fig. 5c and 5 d.

In this regard, the related configuration and concept of the second embodiment are similar to those of the first embodiment, and thus, the description thereof will not be repeated here.

The foregoing description of several embodiments of the application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration, configurations and/or steps disclosed, and obviously many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention and all equivalents be defined by the following claims.

Claims

1. A valve clip with a sealing device comprising a clipping arm, a central rod and a sealing device, characterized in that: the sealing device comprises a blocking piece and a traction piece, the blocking piece is arranged on the central rod in a penetrating mode, one end of the traction piece is connected with the blocking piece, and the other end of the traction piece is connected with the central rod; and the barrier is a flexible member.

2. The valve clip with sealing device of claim 1, wherein: when the valve clip is preassembled, the blocking part is attached to the central rod, and after the valve clip is fixed with the autologous valve, the blocking part swells due to blood impact and blocks the backflow of blood.

3. A valve clip with sealing means according to claim 2, wherein: the blocking piece is of a generally sheet-like structure in a natural state, and is of a generally umbrella-like structure when the blocking piece is bulged.

4. A valve clip with sealing means according to claim 3, wherein: when the blocking piece swells, at least part of the blocking piece contacts or is attached to the clamping arm.

5. The valve clip with sealing device of claim 1, wherein: the periphery of the blocking piece is provided with a skirt edge, and the skirt edge is perpendicular to the central rod in a natural state.

6. The valve clip with sealing device of claim 1, wherein: the pull member is a flexible wire or filament and is folded between the clamping arm and the central rod when pre-installed.

7. The valve clip with sealing device of claim 6, wherein: the far end of the central rod is provided with a mounting groove, and when the central rod is preassembled, the traction piece is placed in the mounting groove.

8. The valve clip with sealing device of claim 1, wherein: the traction piece is a rigid rod, when the valve clip is preassembled, the traction piece is attached to the central rod, and when the blocking piece is impacted by blood, the traction piece is opened and forms an included angle with the central rod.

9. The valve clip with sealing device of claim 1, wherein: the diameter of the blocking piece is larger than or equal to the diameter of the clamping arm at the maximum opening angle.

10. The utility model provides a valve presss from both sides with sealing device, catches shell fragment, well core rod and sealing device including clamping arm, leaflet, its characterized in that: the sealing device is arranged on the central rod in a penetrating mode, the sealing device is connected with the valve leaf catching elastic sheet and is a flexible piece, the sealing device is of a sheet structure in a natural state, and the sealing device can be inflated and is of an umbrella structure in general after being impacted by blood.