A repair device for preventing valve regurgitation

Abstract

The present application relates to the field of medical devices, and in particular to a repair device for preventing valve regurgitation, comprising a fixing unit, a closing aid and an adjusting member, wherein the fixing unit is connected to the closing aid, the fixing unit is anchored at atrial tissue or an autologous valve ring, the closing aid is provided with a first frame, one end of the adjusting member is connected to the first frame, the proximal end of the adjusting member is fixed on the apex or ventricular tissue, and when the closing aid follows the movement of the autologous valve leaflet, the adjusting member and the first frame slide relative to each other; the adjusting member and the first frame can slide relative to each other, so that the closing aid can adjust its position in real time according to the direction of blood flow impact when twisting or restoring, so as to avoid stress damage to the closing aid and affect the treatment effect of regurgitation.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a repair device for preventing valve regurgitation. Background Art

[0002] The mitral valve is located at the left atrioventricular orifice and is composed of five parts: the valve ring, valve leaflets, chordae tendineae, papillary muscles, and commissural connections. Its accurate anatomical name is the mitral apparatus (mitral apparatus) or mitral complex (mitral complex).

[0003] The tricuspid valve is located at the right atrioventricular orifice and has three nearly triangular sail-shaped valves. The base of the valve is attached to the fibrous ring of the atrioventricular orifice. Functionally, the fibrous ring, valve, chordae tendineae and papillary muscles can be seen, forming the tricuspid valve complex (tricuspidvalvarcomplex).

[0004] Mitral regurgitation can be divided into the following two types: 1. Rheumatic mitral regurgitation, mainly caused by mitral valve insufficiency, can cause blood to flow in reverse, thereby mixing different bloods, causing the heart to pump blood and oxygen delivery function to decline. 2. Non-rheumatic mitral regurgitation, usually refers to mitral regurgitation of varying degrees caused by abnormalities of the mitral valve itself and its surrounding anatomical structures in addition to rheumatic valvular disease. There are many causes of non-rheumatic mitral regurgitation, the more common ones are: mitral valve prolapse, papillary muscle insufficiency or chordae tendineae rupture, left atrial myxoma, valve ring calcification, congenital valve malformation, infective endocarditis, etc. Mitral regurgitation can also be divided into three types: functional, degenerative or mixed. The most common are degenerative and functional mitral regurgitation. Functional mitral regurgitation is generally secondary to impaired left ventricular wall motion, left ventricular dilatation, and papillary muscle dysfunction, and is generally seen in patients with heart failure. This group of patients also includes ischemic mitral regurgitation secondary to coronary artery disease and mitral regurgitation associated with non-ischemic cardiomyopathy. Degenerative mitral regurgitation disease is generally considered to be a pathological change in the valve structure or pathological changes in the subvalvular structure, including abnormal extension or rupture of the chordae tendineae.

[0005] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular dilatation, and dilatation of the tricuspid valve ring. After tricuspid regurgitation occurs, right heart failure symptoms such as fatigue, ascites, edema, liver pain, indigestion, and poor appetite worsen. Tricuspid regurgitation is mainly divided into functional tricuspid regurgitation and organic tricuspid regurgitation. The number of organic valve regurgitations caused by rheumatic fever is very small, and most of them are functional regurgitations. The most common cause is that pulmonary hypertension causes right ventricular dilatation and dilatation of the tricuspid valve ring, resulting in relative tricuspid regurgitation while the structure of the valve itself is normal. Such as rheumatic mitral valve disease, congenital cardiovascular disease, cor pulmonale, etc.

[0006] Traditional treatments for mitral and tricuspid valve regurgitation include medications for mild to severe regurgitation and surgical methods with corresponding surgical indications. Among them, surgical methods also include mitral valve and tricuspid valve replacement and mitral valve and tricuspid valve repair. For simple mitral valve regurgitation, only 30% of patients require mitral valve replacement, and the rest only need mitral valve repair. Among surgical methods, typical open-chest and open-heart surgery is too invasive, requires extracorporeal circulation, and has a high incidence of complications and infection risks. In order to reduce surgical risks, catheter-interventional replacement and repair surgical methods have been developed.

[0007] According to the literature [Enriquez-Sarano M, Schaff HV, Orszulak TA, et al. Valve valve replacement improves the outcome of surgery for valve regurgitation: a multivariate analysis [J]. Circulation, 1995, 91 (4): 1022-1088], replacement surgery has a higher total surgical mortality rate and a lower survival rate. The following are the urgent problems to be solved in transcatheter treatment of valvular regurgitation: reducing the amount of implants while ensuring the anti-regurgitation effect; the anti-regurgitation device must be accurately positioned and firmly fixed to the part to be treated; the anti-regurgitation device needs to minimize the impact on the movement of the remaining leaflets with normal function; the anti-regurgitation device needs to adapt to the differences in the physiological structure of the valve ring. The following are the technical highlights of different anti-regurgitation devices in the current existing technology.

[0008] Patent CN2014103225948 discloses a prosthesis for preventing valve regurgitation, including a fixing unit, a connecting piece and a closing aid. The fixing unit includes a fixing piece and an anchoring piece. The connecting piece is flexible, and its distal end is connected to the proximal end of the fixing piece, and its proximal end is connected to the distal end of the closing aid. The fixing piece is fixed to the patient's atrial wall or valve ring through the anchoring piece. The width of the fixing piece when unfolded is less than 2 / 3 of the circumference of the valve tissue ring. The closing aid is located between the patient's own leaflets when in a free state. The maximum width of the closing aid is less than the maximum width of a single unfolded leaflet of the own leaflet. The proximal end of the anchoring piece is provided with an anti-slip end. In this technical solution, the adjustment device and the unfolding device are fixedly connected, and the orientation of the closing aid cannot be adjusted in real time according to the impact direction and impact strength of the blood flow, resulting in stress and strain of the closing aid after long-term implantation, and even local fiber tearing, resulting in functional failure of the closing aid, affecting the effect of treating regurgitation.

[0009] Patent CN2018106477652 discloses an implant device for preventing valvular regurgitation and its delivery system, including an expansion mechanism, a core member and a closing aid member, wherein the expansion mechanism is connected to the core member, and the distal end of the closing aid member is connected to the expansion mechanism. The closing aid member is flexible. In a free state, the expansion mechanism is partially or completely located in the patient's atrium, or the expansion mechanism is completely located in the patient's own atrioventricular valve ring, and the closing aid member is partially located between the patient's own valve leaflets. A limiting member is provided at the proximal end of the closing aid member, and the distal end of the limiting member is connected to the closing aid member, and the proximal end of the limiting member is connected to the core member or is fixed to the patient's heart tissue. As the patient's own valve closes, the closing aid member can partially fit the core member, and at least one end of the core member is fixed to the patient's heart tissue. In this technical solution, the skeleton and the limiting part are also fixedly connected, and the position of the closing aid cannot be adjusted in real time according to the impact direction and impact strength of the blood flow. Secondly, after the blood flows from the atrium to the ventricle, it fills in the ventricle, causing part of the blood to flow back to the atrium. At this time, the tip of the valve leaflet will reflux, affecting its treatment effect.

[0010] In summary, the repair devices in the prior art cannot adjust the position of the closing aid in real time according to the impact direction and impact force of the blood flow, which leads to stress and strain in the closing aid after long-term implantation, and even local fiber tearing, resulting in functional failure of the closing aid and failure to effectively prevent reflux at the tip of the valve leaflet, and a series of other problems. Summary of the invention

[0011] This application is proposed in view of the above and other more concepts.

[0012] One of the purposes of the present application is to overcome the deficiencies of the prior art. For example, in the prior art, the closing aid and the adjusting member are fixedly connected. When the blood flows through the closing aid, the closing aid cannot be adjusted in real time according to the direction and force of the blood flow, so that the force on each area of ​​the closing aid is uneven, which easily leads to problems such as stress fatigue and fiber tearing. A repair device for preventing valve regurgitation is provided.

[0013] According to another aspect of the present application, a repair device for preventing valve regurgitation is provided, comprising a fixing unit, a closing aid and an adjusting member, wherein the fixing unit is connected to the closing aid, the fixing unit is anchored at atrial tissue or a native valve ring, the closing aid is provided with a first skeleton, the distal end (one end) of the adjusting member is connected to the first skeleton, the proximal end (the other end) of the adjusting member is fixed to the apex or ventricular tissue, and when the closing aid follows the movement of the native valve leaflet, the adjusting member and the first skeleton produce relative sliding.

[0014] According to one embodiment, when the valve is in an open state, the closing aid is twisted by the impact of blood flow, and the adjustment member and the first frame slide relative to each other. Meanwhile, the first frame twists along with the closing aid.

[0015] According to one embodiment, the closing aid has a preset shape. When the valve is in a closed state, the closing aid assists the native valve leaflets to close. During this process, the first frame follows the closing aid to return to the preset shape, and the adjustment member and the first frame slide relative to each other.

[0016] According to an embodiment, the first frame is made of a metal memory alloy, which can prevent the closing aid from curling up and being difficult to unfold when implanted.

[0017] According to an embodiment, a connection structure is provided on the first frame, and the adjustment member passes through the connection structure to be connected to the first frame.

[0018] According to one embodiment, the connection structure is a connection hole or a connection pipe.

[0019] According to an embodiment, at least two connection holes are disposed on the first frame, and the connection holes are evenly distributed on the first frame.

[0020] According to a preferred embodiment, the connection holes are arranged on the left and right sides of the first frame.

[0021] According to an embodiment, the adjusting member includes an adaptive member and a stabilizing member, the adaptive member passes through the connecting hole to achieve sliding connection, and the stabilizing member is fixedly connected to the first skeleton.

[0022] According to an embodiment, a stabilizing hole is provided on the first frame, and the stabilizing hole is arranged in a middle area of ​​the first frame, and the stabilizing member is fixedly connected to the stabilizing hole.

[0023] According to one embodiment, the adaptive member and the stabilizing member are linear members, and the proximal end portion of the adaptive member and the proximal end portion of the stabilizing member are merged into one strand.

[0024] According to one embodiment, the adaptive member and the stabilizing member are wire, filament or sheet-like structures.

[0025] According to one embodiment, the first skeleton has a bionic leaflet morphology, and the first skeleton is an arched structure.

[0026] According to an embodiment, the first frame may also be provided with a reinforcing rod to further enhance the structural strength of the first frame.

[0027] According to one embodiment, the first skeleton is arched from the ventricle to the atrium. The advantage of such a design is that when the native valve is closed, the blood in the ventricle will be squeezed toward the atrium, making it very easy for the tip of the valve leaflet to reflux. The first skeleton is arched from the ventricle to the atrium, which can cover the blood and avoid reflux. This design conforms to hemodynamics and has great clinical significance.

[0028] According to one embodiment, the fixing unit includes a second frame and a fabric layer, and a developing piece is provided on the outer edge of the second frame; during surgery, the developing piece facilitates precise positioning of the fixing unit.

[0029] According to one embodiment, the repair device also includes an anchoring needle, and the fixing unit is anchored at the atrial tissue or the autologous valve ring through the anchoring needle. The anchoring needle includes a needle piercing piece, a developing tube arranged at the distal end of the needle piercing piece, and an anti-slip piece; the developing tube can be a tantalum tube, or other tubes with a developing function.

[0030] According to one embodiment, a delivery system is further included, which can deliver the repair device to the target position and can deliver the anchoring needle to the fabric layer of the fixation unit to complete the anchoring.

[0031] According to another embodiment, a repair device for preventing valve regurgitation includes a fixing unit, a closing aid and an adjusting member, wherein the fixing unit is connected to the closing aid, the fixing unit is anchored at atrial tissue or a native valve ring, the closing aid is provided with a first skeleton, the adjusting member is an elastic member, the distal end of the adjusting member is connected to the first skeleton, the proximal end of the adjusting member is fixed to the apex or ventricular tissue, and the stroke of the adjusting member changes with the movement of the closing aid.

[0032] Compared with the prior art, the advantages of the technical solution of the present application include at least the following:

[0033] In the prior art, the closing aid and the adjusting member are fixedly connected. When blood flows through the closing aid, the closing aid cannot be adjusted in real time according to the direction of blood flow and the impact force, so that the force on each area of ​​the closing aid is uneven, which is prone to problems such as stress fatigue and fiber tearing. According to an idea of ​​the present application, when the closing aid follows the movement of the native valve leaflet, the adjusting member and the first skeleton slide relative to each other, so that the closing aid and the adjusting member can produce relative displacement under the impact of blood flow, and make adjustments in real time, so that the closing aid can adapt to a stable state and achieve an optimal state of movement. At the same time, it can also disperse the impact force of blood flow to avoid concentrated force on a certain area for a long time, causing stress fatigue and even fiber tearing, which affects the effect of treating reflux.

[0034] According to one concept of the present application, the adjusting member includes an adaptive member and a stabilizing member. The adaptive member can adjust the movement position of the closing aid member in real time, and the stabilizing member can prevent the closing aid member from twisting excessively and also prevent the closing aid member from being overturned into the atrium by the impact of blood flow.

[0035] According to one concept of the present application, the first skeleton is arched from the ventricle to the atrium. The advantage of such a design is that when the native valve is closed, the blood in the ventricle will be squeezed toward the atrium, making it very easy for the tip of the valve leaflet to reflux. The first skeleton is arched from the ventricle to the atrium, which can cover the blood and avoid reflux. This design conforms to hemodynamics and has great clinical significance.

[0036] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below and are predictable and understandable to those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] The above-mentioned features and advantages and other features and advantages of these embodiments and the manner in which they are achieved will become more apparent, and the embodiments of the present application can be better understood by referring to the following description together with the accompanying drawings, in which:

[0038] Figure 1a and 1b It is a schematic diagram of the overall structure of the repair device of the invention and a schematic diagram of the overall structure of the repair device positioned in the heart.

[0039] Figure 2a to 2d This is a schematic diagram showing the first frame of the present invention being twisted with the closing aid and the adaptive member moving.

[0040] Figure 3a to 3e It is a schematic structural diagram of the first skeleton of the present invention.

[0041] Figure 4 It is a schematic structural diagram of the anchoring needle of the present invention.

[0042] Figure 5 This is another embodiment of the adjusting member of the present invention.

[0043] The features indicated by the numbers in the accompanying drawings are as follows:

[0044] 1-repairing device, 11-fixing unit, 111-second skeleton, 1111-developing part, 112-fabric layer, 12-closing aid, 121-first skeleton, 1211-connecting structure, 12111-connecting hole, 122-stabilizing hole, 13-adjusting part, 131-adaptive part, 132-stabilizing part, 14-anchoring needle, 141-puncture part, 142-developing tube, 143-anti-slip part. DETAILED DESCRIPTION

[0045] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the present application will be described. From these descriptions, drawings and claims, other features, purposes and advantages of the present application can be clearly seen.

[0046] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and may be implemented or executed in various ways. Each example is provided by explaining the disclosed embodiments rather than limiting them. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence disclosed in the present application. For example, a feature illustrated or described as part of an embodiment may be used together with another embodiment to still produce another embodiment. Therefore, the present application discloses and covers such modifications and variations within the scope of the appended claims and their equivalent elements.

[0047] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to be open-ended to include the items listed thereafter and their equivalents and additional items.

[0048] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0049] In the present application, the term "the other end" or "proximal end" or "proximal side" refers to the end or side closer to the centrifugal tip, and "one end" or "distal end" or "distal side" refers to the end or side farther from the centrifugal tip.

[0050] One of the purposes of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems.

[0051] Embodiment 1

[0052] like Figure 1a and 1b As shown, a repair device 1 for preventing valve regurgitation according to an embodiment of the present application is illustrated, comprising a fixing unit 11, a closing aid 12 and an adjusting member 13, wherein the fixing unit 11 is connected to the closing aid 12, the fixing unit 11 is anchored at the atrial tissue or the native valve ring, the closing aid 12 is provided with a first skeleton 121, the distal end of the adjusting member 13 is connected to the first skeleton 121, the proximal end of the adjusting member 13 is fixed on the apex or ventricular tissue, and when the closing aid 12 follows the movement of the native valve leaflet, the adjusting member 13 and the first skeleton 121 slide relative to each other.

[0053] In the first embodiment, when the valve is in the open state, the closing aid 12 is twisted by the impact of blood flow. Figure 2a and 2b As shown, the adjusting member 13 and the first frame 121 slide relative to each other, and at the same time, the first frame 121 twists along with the closing aid 12 .

[0054] In the first embodiment, the closing aid 12 has a preset shape. When the valve is in a closed state, the closing aid 12 assists the native valve leaflets to close. During this process, the first frame 121 follows the closing aid 12 to return to the preset shape. At the same time, the adjustment member 13 and the first frame 121 slide relative to each other. Figure 2c and 2d shown.

[0055] In the first embodiment, a connection structure 1211 is provided on the first frame 121, and the adjustment member 13 passes through the connection structure 1211 and is connected to the first frame 121. Figure 3a and 3b shown.

[0056] In the first embodiment, the connection structure 1211 is at least two connection holes 12111, and the two connection holes 12111 are arranged on the left and right sides of the first frame 121. Figure 3d and 3e shown.

[0057] In the first embodiment, the adjusting member 13 includes an adaptive member 131 and a stabilizing member 132 . The adaptive member 131 passes through the connecting hole 12111 to achieve sliding connection, and the stabilizing member 132 is fixedly connected to the first frame 121 .

[0058] In the first embodiment, a stabilizing hole 122 is provided on the first frame 121 , and the stabilizing hole 122 is disposed in a middle area of ​​the first frame 121 , and the stabilizing member 132 is fixedly connected to the stabilizing hole 122 .

[0059] In the first embodiment, the adaptive member 131 and the stabilizing member 132 are linear members, and the proximal end portion of the adaptive member 131 and the proximal end portion of the stabilizing member 132 are combined into one strand; the advantage of such a design is that it can prevent the adaptive member 131 and the stabilizing member 132 from contacting and rubbing with other tissues in the ventricle (such as papillary muscles, tendons, etc.), causing damage to the tissues and causing wear and tear of the adaptive member 131 and the stabilizing member 132. The adaptive member 131 and the stabilizing member 132 formed into one strand can quickly form a thrombus and fibrous tissue wrapping after implantation, and the formed strand can reduce the breakage of the single strand of the closing aid 12 under the cyclic tension state.

[0060] In the first embodiment, the first frame 121 has a bionic leaflet shape, and the first frame 121 is an arched structure. Figure 3c shown.

[0061] In the first embodiment, the first skeleton 121 is arched from the ventricle to the atrium. The advantage of this design is that when the native valve is closed, the blood in the ventricle will be squeezed toward the atrium, making it very easy for the tip of the valve leaflet to reflux. The first skeleton 121 is arched from the ventricle to the atrium, which can cover the blood and avoid reflux. This design conforms to hemodynamics and has great clinical significance.

[0062] In the first embodiment, the fixing unit 11 includes a second frame 111 and a fabric layer 112. The outer edge of the second frame 111 is provided with a developing member 1111. During surgery, the developing member 1111 facilitates accurate positioning of the fixing unit 11. Figure 1a shown.

[0063] In the first embodiment, the repair device 1 further includes an anchoring needle 14, through which the fixing unit 11 is anchored at the atrial tissue or the autologous valve ring. The anchoring needle 14 includes a needle piercing member 141, a developing tube 142 disposed at the distal end of the needle piercing member 141, and an anti-slip member 143; the developing tube 142 may be a tantalum tube, or may be other tubes with a developing function, such as Figure 4 and Figure 1b shown.

[0064] The first embodiment also includes a delivery system, which can deliver the repair device 1 to the target location and can deliver the anchoring needle 14 to the fabric layer 112 of the fixing unit 11 to complete the anchoring.

[0065] An exemplary operation process of repairing a mitral valve of a repair device 1 for preventing valve regurgitation in the first embodiment is as follows:

[0066] 1. The delivery system is delivered through the patient's left ventricle to the left atrium via a transapical approach.

[0067] 2. The repair device 1 is delivered to the patient's native valve annulus by the delivery system, and the anchoring needle 14 is pushed at the same time, so that the fixing unit 11 on the repair device 1 is anchored at the patient's native valve annulus;

[0068] 3. Fix the proximal end of the adjusting member 13 at the apex of the heart to complete the implantation of the repair device 1.

[0069] Embodiment 2

[0070] The second embodiment is substantially the same as the first embodiment, except that in this embodiment the adjusting member 13 and the first frame 121 may be fixedly connected, and the adjusting member 13 is an elastic member.

[0071] A repair device 1 for preventing valvular regurgitation comprises a fixing unit 11, a closing aid 12 and an adjusting member 13, wherein the fixing unit 11 is connected to the closing aid 12, the fixing unit 11 is anchored at atrial tissue or an autologous valve ring, the closing aid 12 is provided with a first skeleton 121, the adjusting member 13 is an elastic member or the adjusting member 13 is provided with an elastic section, the distal end of the adjusting member 13 is fixedly connected to the first skeleton 121, the proximal end of the adjusting member 13 is fixed on the apex or ventricular tissue, and the stroke of the adjusting member 13 changes with the movement of the closing aid 12.

[0072] In the first embodiment, the adjusting member 13 is fixed on the left and right sides of the first frame 121. Figure 5 shown.

[0073] In the first embodiment, when the closing aid 12 is twisted or restored, the adjusting member 13 is stretched to change its stroke and also restore the closing aid 12 to a preset shape.

[0074] In this regard, the relevant structure and concept of the second embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0075] The foregoing description of the above-described embodiments of the present application is presented for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise configurations, constructions, and / or steps disclosed, and it is apparent that many modifications and variations may be made in light of the teachings above. The scope of the present invention and all equivalents are intended to be defined by the appended claims.

Claims

1. A repair device for preventing valve regurgitation, comprising a fixing unit, a closing aid and an adjusting member, wherein the closing aid is anchored at atrial tissue or a native valve ring through the fixing unit, characterized in that: The closing aid is provided with a first frame, one end of the adjusting member is connected to the first frame, and the other end of the adjusting member is fixed on the ventricular tissue. When the closing aid follows the movement of the native valve leaflet, the adjusting member and the first frame slide relative to each other. The closing aid has a preset shape. When the closing aid is twisted or restored by the impact of blood flow, the adjusting member and the first frame slide relative to each other. At the same time, the first frame twists or restores with the closing aid. The adjusting member includes an adaptive member and a stabilizing member. The adjusting member is an elastic member. At least two connecting holes are provided on the first frame. The connecting holes are arranged on the left and right sides of the first frame. The first frame is provided with a stabilizing hole. The stabilizing hole is arranged in the middle area of ​​the first frame. The distal end of the stabilizing member is fixedly connected to the stabilizing hole. The adaptive member and the stabilizing member are linear components. The distal end of the adaptive member passes through the connecting hole to form a closed loop structure to achieve sliding connection. The proximal end of the adaptive member and the proximal end of the stabilizing member are merged into one strand.

2. A repair device for preventing valve regurgitation according to claim 1, characterized in that: The first frame has a bionic leaflet morphology, and the first frame is an arched structure.

3. A repair device for preventing valve regurgitation according to claim 1, characterized in that: The fixing unit comprises a second frame and a fabric layer, and a developing member is arranged on the outer edge of the second frame.

4. A repair device for preventing valve regurgitation according to claim 1, characterized in that: The repair device also includes an anchoring needle, through which the fixing unit is anchored at the atrial tissue or the autologous valve ring. The anchoring needle includes a needle piercing member, a developing tube arranged at the distal end of the needle piercing member, and an anti-slip member.

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