Patent Application: US-42228709-A

Abstract:
a method and apparatus directed to the repair of regurgitant mitral valves . mitral valve regurgitation occurs due to miscoaptation of mitral valve leaflets . the mitral valve repair apparatus of the present invention is comprised of a tongue plate which is supported by a suture ring . the apparatus is inserted into the mitral valve orifice with the suture ring sutured to the mitral valve annulus placing the tongue plate between the two mitral valve leaflets . when the mitral valve opens , blood flows through the orifices of the apparatus . when the mitral valve closes , the two miscoaptated mitral valve leaflets cover the orifices on the apparatus and the tongue plate blocks the hole formed by leaflets and seals the leaky flow .

Description:
disclosed herein is an improved method and apparatus for repairing a heart &# 39 ; s regurgitating mitral valve . the numerous innovative teachings of the present invention will be described with particular reference to several embodiments ( by way of example , and not of limitation ). all figures referred to will use the following descriptions for reference numbers : left atrium ( 1 ), mitral valve ( 2 ), annulus ( 2 . 1 ), anterior leaflet ( 2 . 2 ), posterior leaflet ( 2 . 3 ), chordate ( 2 . 4 ), papillary muscle ( 3 ), mitral valve coaptation plate ( 4 ), suture ring ( 4 . 1 ), tongue plate ( 4 . 2 ), extension rods or bar ( 4 . 3 ), left ventricle ( 5 ), aortic valve ( 6 ), aortic artery ( 7 ). reference is first made to fig1 , a schematic of a human heart and its four heart valves . in the left heart , the mitral valve ( 2 ) lies between the left atrium ( 1 ) and the left ventricle ( 5 ) to control blood flow from the left atrium ( 1 ) to the left ventricle ( 5 ). a dysfunctional mitral valve causes regurgitation where blood flows backward from the left ventricle ( 5 ) to the left atrium ( 1 ) during systole . mitral regurgitation can cause pulmonary congestion and a dilated left ventricle which ultimately can cause heart failure and mortalities . fig1 also shows the mitral valve coaptation plate ( 4 ) implanted in a regurgitant mitral valve ( 2 ) in the left heart . orientation of the coaptation plate is demonstrated from this depiction . reference is now made to fig2 , wherein a mitral valve schematic is presented . the mitral valve is a complex load bearing structure that consists of an annulus ( 2 . 1 ), two leaflets ( 2 . 2 and 2 . 3 ), chordae ( 2 . 4 ), papillary muscles ( 3 ), and the underlying left ventricular myocardium . the anterior ( 2 . 2 ) and posterior leaflets ( 2 . 3 ) are attached to the annulus ( 2 . 1 ). the annulus ( 2 . 1 ) is an anatomical structure joining the leaflets ( 2 . 2 and 2 . 3 ) and left ventricle ( 5 ) wall . it is divided into the fibrous annulus in the anteromedial section and the myocardium annulus in the posterolateral section , according to annulus histology . the chordae ( 2 . 4 ) originate from papillary muscles ( 3 ) and attach to the leaflets ( 2 . 2 and 2 . 3 ). they prevent leaflets ( 2 . 2 and 2 . 3 ) from prolapsing into the left atrium ( 1 ) during systole . the papillary muscles ( 3 ) are attached to the wall of the left ventricle . reference is now made to fig3 a and 3b , wherein a normal functioning mitral valve is shown in the closed position from the lateral and atrial view . in a normal functioning mitral valve , no gaps are present between the leaflets in the closed position . thus , in a normal functioning mitral valve , regurgitation is not present . reference is now made to fig4 a and 4b , wherein a regurgitating mitral valve is shown from the lateral and atrial view . in a regurgitating mitral valve , gaps are present between the leaflets in the closed position . these gaps or miscoaptation of the leaflets allow blood to flow back into the left atrium from the left ventricle during systole . this backflow is referred to as regurgitation . reference is now made to fig5 a - 5f , wherein several embodiment of the mitral valve coaptation plate are shown . the mitral valve coaptation plate is composed of a suture ring ( 4 . 1 ) and a tongue plate ( 4 . 2 ) even if both may be made into a whole body . the suture ring ( 4 . 1 ) allows the apparatus to be attached to the mitral valve annulus ( 2 . 1 ). the suture ring ( 4 . 1 ) looks like a “ d ” in a saddle shape and matches the size and shape of the native mitral valve annulus ( 2 . 1 ). the anterior section of the suture ring ( 4 . 1 ) is relatively straight from trigone to trigone . the posterior section of the suture ring ( 4 . 1 ) is a half circle . septal - lateral diameter of the suture ring is controlled so as to be close to the native mitral valve annulus in size and smaller than the dilatated annulus . the suture ring can be a partial ring with separate anterior and posterior sections of the suture ring in which support is needed to connect the partial suture ring and tongue plate . the whole suture ring ( 4 . 1 ) is preferably manufactured from a rigid or semi - rigid material and covered with dacron material or other coating materials which are compatible to blood . the covering has a soft texture which is suitable for suturing to the mitral valve annulus . the whole suture ring ( 4 . 1 ) can be deformable to match the patient &# 39 ; s annulus ( 2 . 1 ) geometry . the tongue plate ( 4 . 2 ) of the mitral valve coaptation plate ( 4 ) is the most important part of the invention . the tongue plate sticks out from the commissural positions of the suture ring ( 4 . 1 ) into the left ventricle ( 5 ). the tongue plate ( 4 . 2 ) matches the free edges of the leaflets ( 2 . 2 and 2 . 3 ) during mitral valve closure , supporting the leaflets and sealing the gap between the leaflets ( 2 . 2 and 2 . 3 ), thereby preventing mitral valve regurgitation . the plate shape , size and orientation are designed to be forgiving to leaflet positions and sizes in a range depending upon the mechanism of mitral regurgitation . the tongue plate has an angle relative to the annulus plane , depending upon papillary muscle tethering in ischemic mitral regurgitation . the whole tongue plate is semi - rigid , pitching a little between two leaflets , self - adjustable to some extent . the tongue plate ( 4 . 2 ) is made of rigid or semi - rigid materials with adequate strength . the surface is covered by plastic materials such as polyurethane or rigid materials such as pyrolytical carbon or nitinnol . if it is made of plastic materials such as polyurethane , the tongue plate can be deformable by injecting a polymer material which is solidified at the end of repair . the holes in the lateral sides of the tongue plate ( 4 . 2 ) depend upon the commissural leaflet size and shape . very small holes or no holes are made in the tongue plate ( 4 . 2 ) for small or bad commissural leaflets . these discretionary holes in the tongue plate provide additional blood flow paths during the open mitral valve position which help wash , via blood circulation , additional areas in the mitral valve . fig5 d demonstrates how the tongue plate ( 4 . 2 ) may take on various dimensions . the length of the tongue plate , the dimension extending from the plane of the suture ring to the tongue plate &# 39 ; s point furthest away in the direction of the left ventricle , can vary . reference is now made to fig6 a and 6b , wherein a mitral valve coaptation plate is shown in a regurgitating mitral valve from the lateral and atrial view . both fig6 a and 6b show the mitral valve in the closed position . as can be seen from these illustrations , the mitral valve leaflets cover the openings of the mitral valve coaptation plate . without the mitral valve coaptation plate , the leaflets would not seal properly . now , with the mitral valve coaptation plate implanted , the gaps between the leaflets are now filled by the tongue plate of the apparatus . reference is now made to fig7 a and 7b , wherein a mitral valve coaptation plate is shown in a regurgitating mitral valve from the lateral and atrial view . both fig7 a and 7b show the mitral valve in the open position . these illustrations show how the blood is allowed to pass through the apparatus in the open position for the mitral valve . the orifices in the apparatus allow the blood to flow through freely . reference is now made to fig8 , wherein the mitral valve coaptation plate is shown in the mitral valve from the apical view and highlights how the leaflets are positioned on the tongue plate when the leaflets are in the closed position . reference is now made to fig9 , wherein the mitral valve coaptation plate is shown in the mitral valve from the apical view and highlights how the leaflets are positioned on the coaptation plate when the leaflets are in the open position . reference is now made to fig1 a - 10d , wherein the coaptation plate is shown with extension rods to help facilitate the attachment of chordae for translocation . the tip of the tongue plate ( 4 . 2 ) can be extended with two rods with hooks which can be used to anchor artificial chordae ( polytetrafluoroethylene ) or other chordae repair . fig1 d shows the rods in the mitral valve coaptation plate . the holes in the lateral sides of the tongue plate ( 4 . 2 ) depend upon the commissural leaflet size and shape . extra supporting rods can be made between the tongue plate and the anterior or posterior annulus ( 2 . 1 ). the tongue plate can be a complete plate across two commissures or a partial plate with one commissure side . reference is now made to fig1 a - 11d , wherein the coaptation plate is shown with an extension bar to help facilitate the attachment of chordae for translocation . the tip of tongue plate ( 4 . 2 ) can be extended with an extension bar with holes , which can be used to anchor artificial chordae ( polytetrafluoroethylene ) or other chordae repair . fig1 d shows the bar as part of the mitral valve coaptation plate . the holes in the lateral sides of the tongue plate ( 4 . 2 ) depend upon the commissural leaflet size and shape . the tongue plate can be a complete plate across two commissures or a partial plate with one commissure side . reference is now made to fig1 a - 12c , wherein the mitral valve coaptation plate is shown with various plate shapes at an offset θ measured from the plane of the suture ring . artificial leaflets can be attached onto the suture ring to replace either or both mitral valve leaflets ( 2 . 2 or 2 . 3 ) to make an artificial heart valve . the leaflets are made of polyurethane or other materials . artificial chordae are used to connect leaflets . in brief , the mitral valve coaptation plate ( 4 ) as described herein supports leaflet coaptation substantially by providing fully forgiving matching of leaflet ( 2 . 2 and 2 . 3 ) position . the mitral valve coaptation plate is designed for different mechanisms of mitral valve regurgitation such as ischemic valve disease , mitral prolapse and chordae elongation or rupture . furthermore , the suture ring ( 4 . 1 ) restores a dilatated mitral valve annulus ( 2 . 1 ) in the septal - lateral diameter . this configuration along with the coaptation plate helps to reduce the gap between the leaflets . the disclosed method and apparatus is generally described , with examples incorporated as particular embodiments of the invention and to demonstrate the practice and advantages thereof . it is understood that the examples are given by way of illustration and are not intended to limit the specification or the claims in any manner . to facilitate the understanding of this invention , a number of terms may be defined below . terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the present invention . terms such as “ a ”, “ an ”, and “ the ” are not intended to refer to only a singular entity , but include the general class of which a specific example may be used for illustration . the terminology herein is used to describe specific embodiments of the invention , but their usage does not delimit the disclosed method , except as may be outlined in the claims . alternative applications for this invention include using this apparatus and method as an alternative solution for a dysfunctional tricuspid valve , aortic valve , or pulmonary valve , in which a tripod coaptation plate is used . consequently , any embodiments comprising a coaptation plate to support leaflets with similar function shall fall into the coverage of claims of the present invention and shall lack the novelty and inventive step criteria . it will be understood that particular embodiments described herein are shown by way of illustration and not as limitations of the invention . the principal features of this invention can be employed in various embodiments without departing from the scope of the invention . those skilled in the art will recognize , or be able to ascertain using no more than routine experimentation , numerous equivalents to the specific procedures and apparatus described herein . such equivalents are considered to be within the scope of this invention and are covered by the claims . all publications and patent applications mentioned in the specification are indicative of the level of those skilled in the art to which this invention pertains . all publications and patent application are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference . in the claims , all transitional phrases such as “ comprising ,” “ including ,” “ carrying ,” “ having ,” “ containing ,” “ involving ,” and the like are to be understood to be open - ended , i . e ., to mean including but not limited to . only the transitional phrases “ consisting of ” and “ consisting essentially of ,” respectively , shall be closed or semi - closed transitional phrases . all of the apparatus and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure . while the apparatus and methods of this invention have been described in terms of preferred embodiments , it will be apparent to those skilled in the art that variations may be applied to the apparatus and / or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept , spirit , and scope of the invention . more specifically , it will be apparent that certain components which are both shape and material related may be substituted for the components described herein while the same or similar results would be achieved . all such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit , scope , and concept of the invention as defined by the appended claims . 1 . gelsomino s , lorusso r , caciolli s , et al ., insights on left ventricular and valvular mechanisms of recurrent ischemic mitral regurgitation after restrictive annuloplasty and coronary artery bypass grafting . j thorac cardiovasc surg , 2008 ; 136 : 507 - 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