Heart valve forming systemTechnical Field
The application relates to the field of medical instruments, in particular to a heart valve forming system.
Background
With the advent of aging population, the incidence of heart valve disease has increased significantly. In particular mitral regurgitation (mitral regurgitation, MR), has a incidence of more than 5 times that of patients with aortic stenosis. It is estimated that there are over 1000 tens of thousands of severe MR patients in our country. MR is the result of poor anterior and posterior mitral valve She Wenge due to changes in the mitral valve leaflet and its structure, and the reflux of blood from the left ventricle to the left atrium, causing symptoms. MR can be classified into primary (organic) and secondary (functional) based on pathogenesis, with about 50% each. Mild MR patients can develop no clinical symptoms for a long time, with a better prognosis. Severe MR patients may be accompanied by symptoms such as palpitations, chest distress, and shortness of breath. Acute severe MR patients are poorly tolerated and die easily. Clinical studies have shown that only patient symptoms can be ameliorated by drug treatment, and that the survival time or surgical timing cannot be prolonged. Surgical valve repair or replacement is recognized as a standard method of treating MR and has been demonstrated to alleviate symptoms and extend survival in patients. But the surgical treatment has the defects of large wound, slow postoperative recovery, obvious postoperative pain, high risk and the like. Meanwhile, 50% of MR patients cannot be effectively treated because of the inapplicable surgical operations due to the high risk factors such as hypocardiac function, advanced age, history of chest opening, etc. Over the last decade, the rapid development of transcatheter mitral valve interventional techniques, particularly MITRACLIP, has brought promise to many patients. Recent studies have shown that MITRACLIP has better therapeutic effects on functional reflux than drug therapy. Facing a huge market, large enterprises and capital disputes are in the line of MR treatment.
Patent CN2022101932385 discloses an implantation instrument for repairing a valve, comprising an annuloplasty device, a control element for controlling the contraction of the annuloplasty device, a fixation element for anchoring the annuloplasty device with heart tissue, said annuloplasty device comprising at least two annuloplasty members anchored adjacently at the native valve annulus or atrial tissue by said fixation element, said control element being manipulated such that said annuloplasty member contracts, and the adjacent ends of said annuloplasty members all come together towards the centre of the native valve. The applicant found in experiments that the technical problems are that 1, although the movement amplitude of the two ends towards the center of the valve is obvious after the contraction of the ring, the too large movement amplitude of the front valve area can influence the blood flow supply of the aorta to cause complications because the front valve area is close to the aortic valve, and 2, the control wire is arranged at the end part of the contraction ring component, when the control wire contracts, the stress of the end part is concentrated, and the strength of the control wire is tested to be larger.
In view of the foregoing, there are several clinical advantages to the above techniques, but there is a need for a new heart valve annuloplasty system that addresses the above problems.
Disclosure of Invention
The present application has been made in view of the above and other ideas. The primary purpose of the present application is to overcome some of the problems and deficiencies of the prior art.
In the aspect of application of atrioventricular valve operation, the application aims to provide a heart valve forming system aiming at a patient with pathological changes of a heart valve and needing interventional treatment, so that the problems of large moving distance of an anterior leaflet area, influence on blood flow supply of an aortic valve and the like in the prior art can be solved.
The technical scheme includes that the heart valve forming system comprises a shrinkage framework, a covering layer, a wire and fixing elements, wherein the covering layer covers the shrinkage framework, the wire is used for controlling the shrinkage of the shrinkage framework, the fixing elements are used for anchoring the shrinkage framework on heart tissues, the wire comprises a control part and a connecting part, the connecting part is connected with the shrinkage framework, the control part is arranged between two end parts of the shrinkage framework, the control part is operated to enable the connecting part to pull the shrinkage framework to shrink, and after the shrinkage framework is implanted, one ends, adjacent to the first shrinkage part and the second shrinkage part, of the first shrinkage part are respectively arranged at two ends of the support framework.
As a further improvement of the invention, the first contraction member and the second contraction member are respectively provided with a wire for controlling contraction, the wire is in a closed loop structure, and after the first contraction member and the second contraction member are anchored on an annulus, the control part is screwed, so that the connecting part drives the first contraction member and the second contraction member to realize contraction.
As a further improvement of the invention, the connecting part of the wire is fixed with the first contraction piece or the second contraction piece along the edge of the first contraction piece or the second contraction piece, and the wire is fixed along the periphery of the edge, so that the stress points of the wire when the first contraction piece or the second contraction piece is pulled are more and more uniform.
As a further development of the invention, the length of the control portion from the adjacent ends of the first and second constriction is two-thirds of the transverse length of the first or second constriction.
As a further improvement of the invention, the first contraction part and the second contraction part comprise a front contraction part and a rear contraction part, the control part is arranged at the juncture of the front contraction part and the rear contraction part, and the control part is operated to ensure that the contraction stroke of the rear contraction part is larger than that of the front contraction part after the first contraction part and the second contraction part are contracted, so that the P2 area of the rear valve obviously moves towards the center of the valve, and the front valve area moves towards the center of the valve in a small range, thereby not only effectively increasing the coaptation area between valve leaflets, but also avoiding the problem of aortic blood flow supply caused by overlarge movement range of the front valve area.
As a further improvement of the invention, the stiffness of the anterior contraction is greater than the stiffness of the posterior contraction, such that after contraction of the first or second contraction, the posterior contraction swings to the center of the valve by a greater extent than the anterior contraction swings to the center of the valve.
As a further improvement of the invention, the invention further comprises a supporting framework which is of an open-loop structure, wherein the supporting framework is respectively connected with the first contraction piece and the second contraction piece, and one ends of the first contraction piece and the second contraction piece, which are adjacent, are respectively arranged at two ends of the supporting framework.
As a further improvement of the invention, the supporting framework is composed of a plurality of supporting units in an omega shape, and the rigidity of the supporting units corresponding to each area of the self-body valve annulus is different, wherein the rigidity of the supporting units positioned in the set ring shrinking area is smaller than that of the supporting units positioned at the juncture of the valve leaflets.
As a further development of the invention, at least one fastening element is anchored in the front constriction region and at least two fastening elements are anchored in the rear constriction region.
As a further improvement of the invention, the cover layer is a fabric and is a closed loop structure which is adapted to the shape of the valve annulus, so that the whole ring can be directly buckled on the self valve annulus without being positioned by excessively relying on images when being implanted.
As a further improvement of the present invention, when the device is used for mitral valve treatment, the set contraction ring area is located in the P2 area of the native valve annulus, and the adjacent ends of the first contraction member and the second contraction member are located in the P2 area of the native valve annulus, so that when the device contracts, the P2 area can significantly move towards the center of the valve, thereby driving the back valve She Xiangqian to abut against the valve leaflet, and increasing the coaptation area between the valve leaflets, so as to effectively treat regurgitation.
Compared with the prior art, the application has the advantages and beneficial technical effects that at least the following are included:
1. In the prior art, when the annuloplasty device is contracted, the P2 area of the self-body valve annulus can be obviously closed to the center of the valve, but due to the interaction of forces, the front valve annulus area can be excessively moved to the center of the valve, and the involution area of the self-body valve leaflet can be increased, but the excessive traction of the front valve leaflet can affect the aortic valve to cause complications, therefore, in one embodiment of the application, the control part is two thirds of the length of the adjacent end parts of the first contraction piece and the second contraction piece relative to the transverse length of the first contraction piece or the second contraction piece, the difference exists between the local contraction amplitude of the first contraction piece or the second contraction piece when the first contraction piece is contracted, the movement amplitude of the P2 area of the valve annulus to the center of the valve is obviously larger than the movement amplitude of the front valve area to the center of the valve, the involution area between the valve leaflets can be effectively increased, the valve regurgitation can be reduced, the excessive movement of the front valve area can be avoided, the influence on the aortic valve can be effectively reduced, the complications after operation can be effectively reduced, and the annuloplasty device has good clinical significance.
2. In an embodiment of the application, the support frame is provided, the support frame is in an open loop structure, the adjacent ends of the first contraction piece and the second contraction piece are respectively arranged at the two ends of the support frame, and the adjacent ends of the first contraction piece and the second contraction piece are arranged in the set contraction ring area, so that the set contraction ring area (namely the P2 area) can be obviously close to the center of the valve during contraction forming, the front valve ring area can counteract the contraction force of part of contraction ring members due to the force provided by the support frame, the moving distance of the front valve ring area to the center of the valve is small, thereby effectively avoiding the influence on the aortic valve.
3. In contrast to the prior art, in an embodiment of the present application, the stent framework is composed of several supporting units, and the supporting units in different regions are not uniform in rigidity, for example, the supporting units in the set annulus region are smaller in rigidity than the supporting units at the leaflet juncture, which makes the annulus contracting member shrink unevenly after contraction, the set annulus contracting region (i.e., the P2 region) is contracted by a larger distance than the anterior annulus region, so that the blood flow supply of the aortic valve is prevented from being affected by the excessive movement distance of the anterior annulus.
Embodiments of the application may achieve other advantageous technical effects not listed one by one, which may be partially described below, and which may be expected and understood by those skilled in the art after reading the present application.
Drawings
The above-mentioned 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:
FIGS. 1a to 1d are schematic structural views of the device for constricting an annulus according to the present invention, wherein FIG. 1d is a schematic form of a filament.
Fig. 2 a-2 d are schematic diagrams illustrating the contraction of a heart valve annuloplasty system according to the present invention on the mitral valve annulus, wherein 2b is a schematic diagram of the device for tightening the annulus on the mitral valve annulus when the control wire is not tightened, and fig. 2d is a schematic diagram of the device for tightening the annulus on the mitral valve annulus after the control wire is tightened.
The parts in the drawings are named as 1-contraction skeleton, 11-first contraction member, 12-second contraction member, 13-front contraction portion, 14-back contraction portion, 2-covering layer, 3-wire, 31-control portion, 32-connection portion, 4-fixing element, 5-support skeleton and 51-support unit.
Examples
Description of the embodiments
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 illustrated and described embodiments 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 drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. Examples are provided by way of explanation, not limitation, of the disclosed embodiments. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to the various embodiments of the application without departing from the scope or spirit of the disclosure. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still a further embodiment. Accordingly, the present 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 if any.
The application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.
In the present application, the proximal end refers to the end that is closer to the operator, and the distal end refers to the end that is farther from the operator.
In the prior art, the native valve is not normally operated during the replacement of the atrioventricular valve, and the conventional treatment means can cause the whole valve to be in an open regurgitation state during the replacement, which results in very short operation time and high risk, and may cause various diseases.
Examples
As shown in fig. 1 a-1 d, a heart valve forming system comprising a device for contracting a native valve annulus and a conveyor for conveying the device into a heart, the device comprising a contracting skeleton 1, a cover layer 2 overlying the contracting skeleton 1, a wire 3 for controlling the contraction of the contracting skeleton 1, a fixation element 4 for anchoring the contracting skeleton 1 to heart tissue, wherein the contracting skeleton 1 comprises a first contracting member 11 and a second contracting member 12, the first contracting member 11 and the second contracting member 12 being provided with a wire 3 for controlling the contraction, respectively, and wherein the wire 3 comprises a control part 31 and a connecting part 32, the connecting part 32 referring to the part connected with the first contracting member 11 or the second contracting member 12, the control part 31 being a part for operating the contracting member to effect contraction, the contracting skeleton 1 being conveyed via the conveyor to a target location in the heart (at the native valve annulus), the anchoring of the contracting skeleton 1 to the native valve annulus by means of the fixation element 4, wherein the end of the first contracting member 11 and the second contracting member 12 adjacent to each other is located in the area P2 of the native valve annulus (i.e. the set contracting ring area), as shown in fig. 2b, and subsequently the control portion 31 is screwed to cause the connecting portion 32 to bring the first contracting member 11 and the second contracting member 12 to contract, further bring the native valve annulus to contract, as shown in fig. 2c and 2d, and the control portion 31 is located at a distance of two thirds of the lateral length of the first contracting member 11 or the second contracting member 12 from the adjacent end of the first contracting member 11 and the second contracting member 12, as shown in fig. 1b, whereby the area P2 of the native valve annulus is moved more than the front valve area is moved towards the valve center, which effectively increases the coaptation area between the valve leaflets, the valve regurgitation is reduced, excessive movement of the front valve area can be avoided, the aortic valve is influenced, postoperative complications are effectively reduced, and the method has good clinical significance.
In this embodiment, the wire 3 is in a closed loop structure, as shown in fig. 1d, the conveyor is provided with a control rod connected with the wire 3 in a detachable manner, and the control rod is rotated to tighten the wire 3, so that the wire 3 is gradually contracted, and the contraction skeleton 1 and the self-body valve ring are further driven to realize contraction, thereby completing the contraction of the ring.
In this embodiment, the connection portion 32 of the wire 3 is fixed to the first contraction member 11 or the second contraction member 12 along the edge of the first contraction member 11 or the second contraction member 12, and fixed along the edge along a circle, so that the stress points of the wire 3 when pulling the first contraction member 11 or the second contraction member 12 are more and more uniform.
In this embodiment, the first constriction 11 and the second constriction 12 each comprise a front constriction 13 and a rear constriction 14, and the control portion 31 is disposed at the junction of the front constriction 13 and the rear constriction 14 as shown in fig. 1a and 1b, and the control portion 31 is operated such that the stroke of the contraction of the rear constriction 14 after the contraction of the first constriction 11 and the second constriction 12 is larger than the stroke of the contraction of the front constriction 13 as shown in fig. 2c and 2d, which causes the P2 region of the rear valve to be significantly moved toward the valve center while the front valve region is moved to a small extent toward the valve center, thereby effectively increasing the coaptation area between the leaflets and avoiding the problem of aortic blood flow supply due to the excessive movement of the front valve region.
In this embodiment, the stiffness of the front constriction 13 is greater than the stiffness of the rear constriction 14, so that after the first constriction 11 or the second constriction 12 has been contracted, the amplitude of the swing of the rear constriction 14 towards the center of the valve is greater than the amplitude of the swing of the front constriction 13 towards the center of the valve.
In this embodiment, the supporting framework 5 is composed of a plurality of supporting units 51 in an "Ω" shape, as shown in fig. 1c, and the rigidity of the supporting units 51 corresponding to each area of the native annulus is different, where the rigidity of the supporting units 51 located in the set ring-shrinking area is smaller than the rigidity of the supporting units 51 at the boundary of the valve leaflet.
In the present embodiment, at least one fixation element 4 is anchored in the region of the front constriction 13 and at least two fixation elements 4 are anchored in the region of the rear constriction 14.
In this embodiment, the cover layer 2 is a fabric, and the cover layer 2 is a closed loop structure adapted to the shape of an annulus, so that the whole annulus can be directly buckled on the native annulus without being excessively dependent on an image for positioning when being implanted.
An exemplary prosthetic mitral valve for a heart valve annuloplasty system of the first embodiment operates as follows:
1. operating the delivery system from the superior vena cava into the right atrium and then through the atrial septum to the left atrium;
2. releasing the device for tightening the annulus from the conveyor, which device is now in a ring-shaped configuration and is laid over the native annulus tissue, further operating the conveyor system to output its fixation element 4 and anchor the device to the native annulus through the fabric layer, as shown in fig. 2a and 2 b;
3. Tightening the controlled retraction wire 3 causes the first and second retraction members 11 and 12 to retract the annulus as shown in figures 2c and 2 d. When the first and second retraction members 11 and 12 are retracted into position, as viewed from the image, the conveyor is removed from the wire 3 and the delivery system is withdrawn, completing the procedure.
The product of the invention is not only suitable for repairing mitral valve diseases, but also suitable for tricuspid valve diseases.
Finally, it should be noted that the foregoing description is only a preferred embodiment of the present invention, and is not intended to limit the invention, but any modifications, equivalents, improvements, etc. within the spirit and principles of the present invention are intended to be included within the scope of the present invention.