Source: http://www.google.com/patents/US20050038509?dq=5,072,412
Timestamp: 2015-05-03 14:16:52
Document Index: 133635614

Matched Legal Cases: ['art 300', 'art 300', 'art 300', 'art 400', 'art 300', 'art 300', 'art 400', 'art 400']

Patent US20050038509 - Valve prosthesis including a prosthetic leaflet - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA prosthesis for repairing a damaged valve such as a heart mitral valve is disclosed. The prothesis comprises a prosthetic valve leaflet mounted on a frame. When implanted in a mitral valve, the leaflet replaces the function of an endogenous valve leaflet and coapts with an opposed endogenous valve leaflet....http://www.google.com/patents/US20050038509?utm_source=gb-gplus-sharePatent US20050038509 - Valve prosthesis including a prosthetic leafletAdvanced Patent SearchPublication numberUS20050038509 A1Publication typeApplicationApplication numberUS 10/641,203Publication dateFeb 17, 2005Filing dateAug 14, 2003Priority dateAug 14, 2003Publication number10641203, 641203, US 2005/0038509 A1, US 2005/038509 A1, US 20050038509 A1, US 20050038509A1, US 2005038509 A1, US 2005038509A1, US-A1-20050038509, US-A1-2005038509, US2005/0038509A1, US2005/038509A1, US20050038509 A1, US20050038509A1, US2005038509 A1, US2005038509A1InventorsKassem AsheOriginal AssigneeAshe Kassem AliExport CitationBiBTeX, EndNote, RefManReferenced by (27), Classifications (7) External Links: USPTO, USPTO Assignment, EspacenetValve prosthesis including a prosthetic leaflet
DETAILED DESCRIPTION Three differing embodiments are illustrated in the drawings. Where like numbers are used to designate elements within the differing embodiments, it may be taken that the same or substantially the same element is present in the differing embodiments. Embodiment Illustrated in FIGS. 1-4, 10-11 FIGS. 1-4 show a heart valve prosthesis generally designated 1. The prosthesis includes a leaflet generally designated 10 and a frame, the latter of which is comprised of a supporting ring 20 and padding 25 enclosed by a sheath 30. In FIGS. 1-3, ring 20 and padding 25 are hidden from view. Ring 20 provides structural support. Padding 25 which is disposed around the periphery of ring 20 provides additional material through which sutures may be placed. Such padding is not considered essential, but its use is considered advantageous because it facilitates attachment of the prosthesis in a heart valve annulus with reduced risk of tearing surrounding tissue. In FIG. 3, it will be seen that sheath 30 includes a first portion 30 a that extends longitudinally through an annular arc and a relatively straight second portion 30 b that extends longitudinally as a chord of the annular arc. Ring 20 and padding 25 (hidden from view in FIG. 3) are correspondingly shaped under the cover of sheath 30. Thus, it will be understood that frame (20, 25, 30) as a whole includes a first portion generally designated 2 that extends longitudinally through an annular arc and a relatively straight second portion generally designated 3 that extends longitudinally as a chord of the annular arc. Along portion 2, sheath 30 wraps partially around ring 20 and padding 25. Along portion 3, sheath 30 wraps fully around ring 20 and padding 25. Leaflet 10 extends downwardly from the arcuate portion 2 of frame (20, 25, 30), and includes a prosthetic surface 12 which extends below and is offset radially inwardly from portion 2. As best seen in FIG. 4, surface 12 is convex in the plane of the cross-section which is depicted. That plane is transverse to the arc through which the frame extends. Although only the one transverse cross-section is shown, it will be understood that surface 12 is convex in a continuum of planes transverse to the arcuate portion of frame (20, 25, 30). Internally, leaflet 10 comprises a concavo-convex supporting skeleton 14 having a lower edge 15 and an upper edge 16, the latter of which is attached to ring 20. Externally, leaflet 10 is coated on opposed sides and around edge 16 with a biocompatible surface material 18. Prosthesis 1 is sized for implant into the mitral valve annulus (not shown in FIGS. 1-4), leaflet 10 being sized such that surface 12 is operatively able to coapt with an opposed valve leaflet (likewise not shown in FIGS. 1-4). When leaflet 10 is used to replace an endogenous posterior leaflet, then approximately 50% of surface 12 typically should serve as operative coapting surface. It may also be noted then when appropriately sized, the outer perimeter of frame (20, 25, 30) typically will enclose an area roughly equal to that of the endogenous anterior leaflet of the valve being repaired. While the general conformation of surface 12 as shown in FIGS. 1-4 presently is preferred, the fundamental requirements are that its shape and position be suitable for coaption with an opposed endogenous leaflet when in use, and to provide this function without adversely affecting the function of a mitral valve. Accordingly, it is contemplated that other conformations are possible. For example, in a cross-section corresponding to that shown in FIG. 4, a prosthetic surface conformed differently from that of surface 12 may have one or more areas of relative flatness rather than being smoothly convex. To facilitate the implant procedure which is discussed below, frame (20, 25, 30) may have a limited degree of flexibility but, when implanted, it obviously must be sufficiently rigid to reliably hold leaflet 10 in a position where coaption will occur. Leaflet 10 is substantially undeflectable. That is to say that leaflet 10 is sufficiently rigid that when in use its position relative to frame (20, 25, 30) remains substantially constant. Various suitable materials may be used in the manufacture of prosthesis 1. Preferably, ring 20 is made of a suitable metal such as titanium. Sheath 30 is made of a suitable flexible biocompatible material such as silicone rubber, polyester knit, ePTFE knit or PTFE knit. Skeleton 14 of leaflet 10 may be made of a suitable plastic or metal such as titanium, and may comprise a rigid skeleton framework rather than the solid body depicted in FIG. 4. A suitable coating material 18 is treated bovine pericardium or its equivalent. This may be seeded with cultured cells to present a more biologically compatible surface, but a range of alternatives will be apparent to those skilled in the art. As is known to those skilled in the art, an important characteristic of any exposed surface used in heart valve prothesis is that it be biocompatible and present minimal risk of damage to blood cells. Bare plastic and metal surfaces generally are not considered to be suitable, and it is therefore desirable that they be suitably coated or sheathed. The required dimensions of prosthesis 1 will depend upon the particular application, and will vary with the size and shape of the heart annulus in which it is to be implanted. Preferably, it is made available in a number of predetermined sizes and a user can select a suitable size from the range available. This approach is used with known annuloplasty prostheses. The use of prosthesis 1 will now be described with reference to FIGS. 10 and 11 which show the prosthesis implanted in the mitral valve of a heart generally designated 300. FIG. 10 depicts the repaired valve in a closed position during systole. FIG. 11 depicts the repaired valve in an open position during diastole. Prosthesis 1 is secured within the annulus of the mitral valve by suturing. Sutures (not shown) are stitched through the material of the sheath 30 and padding 25 and through the supporting annulus tissue of heart 300 using routine methods well known to those skilled in the art. Heart 300 includes a ventricle wall 301 formed around a ventricular lumen 302 and an anterior leaflet 303 having an atrial surface 304. Movement of leaflet 303 is limited by chordae 320. When ventricle wall 301 contracts during systole, pressure on blood within ventricular lumen 302 forces anterior leaflet 303 outwardly. As shown in FIG. 10, atrial surface 304 of anterior leaflet 303 then presses against and coapts with coapting surface 12 of leaflet 10. As ventricle wall 301 relaxes during diastole, blood flows inwardly through themitral valve. As indicated in FIG. 11, anterior leaflet 303, with its movement again restricted by chordae 320, then folds inward toward ventricular lumen 302 allowing blood to flow into the lumen past leaflet 10. When prosthesis 1 is implanted into heart 300, the endogenous posterior leaflet (not shown) may be left in place and compressed down by suturing to the surrounding tissue, may be excised completely, may be left intact or may be used to supply suitable tissue for any necessary repairs to the opposing anterior leaflet. In general it is expected than any of these alternatives will be equally effective, but details of the installation may be adapted depending on the preference of the user and to suit specific circumstances. A particular advantage of the invention disclosed is that the endogenous posterior leaflet may be used as a ready source of tissue for repairing defects in the anterior mitral leaflet. Embodiment Illustrated in FIGS. 5-7, 12 FIGS. 5-7 show a heart valve prosthesis generally designated 41. Except for minor modifications consequential to the addition of two projecting struts 70, 70′, and the struts themselves, the construction of prosthesis 41 is substantially the same as that of prosthesis 1. The structure includes a leaflet generally designated 42 with a prosthetic surface 12, a supporting ring 20 and padding 25. Ring 20 and padding 25 are enclosed by a sheath 50 and together comprise a frame (20, 25, 50). Leaflet 42 is substantially the same as leaflet 10 of prosthesis 1 except where it joins with struts 70, 70′ (see FIG. 7). Likewise, sheath 50 is substantially the same as sheath 30 of prosthesis 1 except where it forms around struts 70, 70′ (see FIG. 7). Struts 70, 70′ are mounted on frame (20, 25, 50) and extend downwardly therefrom to distal ends 72, 72′ which are distanced away from both the frame and prosthetic surface 12. Preferably, ends 72, 72′ are positioned directly below at a distance 74 from surface 12. Also distance 74 should approximate the length of a normal heart chordae (not shown in FIGS. 5-7). In the case of humans, this distance typically may fall in the range of 13 mm to 30 mm. As will be seen with particular reference to FIG. 7, struts 70, 70′ each include a supporting skeleton 76 formed integrally with supporting skeleton 40 of leaflet 42, and a generally spherical suture pad 78 at the lower end of skeleton 76. Although the integral formation is not essential to the function of the prosthesis, it assists to firmly fix the distance 74 between the lower edge of prosthetic surface 12 and the distal end 72, 72′ of each strut. Each strut, including its skeleton 76 and pad 78, is covered with a biocompatible material 80 preferably of the same type used for sheath 50. Struts 70, 70′ each comprise a means extending downwardly from frame (20,25,50) for holding a suture (not shown in FIGS. 5-7) at a position distanced away from both the frame and prosthetic surface 12. The particular position in the embodiment shown is at the distal ends of the struts. However, it will be readily apparent to those skilled in the art that alternative means are possible and may be used to perform the same function. For example a strut may be structured to provide suture attachment positions at a number of alternative positions along it length, or along a continuum of possible positions, thereby allowing a user to select a preferred position for a given situation. The use of prosthesis 41 will now be described with reference to FIG. 12 which shows the prosthesis implanted in the mitral valve of a heart generally designated 400. The repaired valve is depicted in a closed position during systole. For the purpose of the following discussion, heart 400 may be considered identical to heart 300 but for the absence of chordae 320 (see FIGS. 10-11) to limit the movement of anterior leaflet 303. Just as prosthesis 1 is secured within the annulus of the mitral valve of heart 300, prosthesis 41 is secured within the annulus of the mitral valve of heart 400 by suturing. The essential added difference is that in heart 400 edge 305 of anterior leaflet 303 is attached to end 72 of strut 70 by means of sutures 200. The length of sutures 200 approximates that of distance 74 seen in FIG. 7. Although not shown, edge 305 at another point is likewise attached to end 72′ of strut 70′ by means of sutures. During systole, the upper atrial surface 304 of anterior mitral leaflet 303 coapts with prosthetic surface 12 of the prosthetic leaflet 10. During diastole which is not illustrated, anterior leaflet 303 is drawn back by the flow of blood from atrium to ventricle in the same manner seen in FIG. 11. By suturing edge 305 to ends 72, 72′, of struts 70, 70′, damaged chordae and support structures can be conveniently replaced. When sutures 200 are of a suitable length, the extent of outward flexure of the edge 305 of anterior leaflet 303 is limited such that when sutures 200 are fully extended as pressure is applied to blood on the ventricular side of prosthesis 41, then at least a portion of the upper atrial surface 304 of leaflet 303 proximate to edge 305 can coapt with the prosthetic surface 12. A particular advantage of prosthesis 41 is the ease with which a suitable length for sutures 200 can be determined. In order to properly limit the outward movement of edge 305 of leaflet 303, the suture length should closely approximate distance 74. If such a length is used, then during systole edge 305 of anterior leaflet 303 necessarily will be approximately adjacent the lower edge of prosthetic surface 12 to allow proper coaptation between surface 12 and the upper atrial surface 304 of anterior leaflet 303. The certainty of distance 74 is a significant advantage over known procedures, in which the appropriate length of sutures 200 must be estimated to take account of variation in the internal dimensions of ventricle wall 301 and papillae. Even if the morphology of the leaflets and their support structures are substantially normal, it requires a particularly high degree of skill and experience to judge an appropriate length for the sutures. In addition it can be extremely difficult to readily access the mitral valve well enough to visualize the structure and to determine an appropriate suture length and anchor points on the ventricle wall. The certainty of suture length in the use of prosthesis 41 can make an operating procedure relatively routine, reduce the skill necessary to successfully complete the operation, and reduce the time required to complete an operation. Risk to the patient is correspondingly reduced. A further advantage of prosthesis 41 is that struts 70,70′ may be attached by suturing or like methods to the interior surface of the wall of the ventricle. In this manner, a strut may act as a prosthetic support for the ventricle wall and compensate for any dilation of the wall. Further, the strut may compensate for variations in the distance between the ventricle wall and the valve leaflets. Accordingly, the embodiment shown in FIGS. 5-7 and 12 is considered to be particularly suited to the repair of abnormalities which affect the support structures of the anterior mitral leaflet. A number of variants to the structure shown in FIGS. 5-7 are possible. For instance, while the particular embodiment includes two struts, cases may arise where only one strut is desired or, alternately, where more than two struts are desired, and the position of such struts may differ from the positions shown in FIGS. 5-7. Further, it will be apparent to those skilled in the art that structures other than struts may be used to hold sutures in desired positions. Embodiment Illustrated in FIGS. 8-9 FIGS. 8-9 show a heart valve prosthesis generally designated 81. The substantive difference between prosthesis 1 and prosthesis 81 is that the latter does not include a straight portion 3 (see FIG. 3) extending as a chord across the arced portion of the frame. A decision that a prosthesis does not require a straight portion 3 will depend upon the circumstances and will be a matter of judgment. In situations where it is determined that the portion of a valve annulus where straight portion 3 of prosthesis 1 normally would be sutured is not in need of correction, then prosthesis 81 may be used instead of prosthesis 1. Although not illustrated in the drawings, it may be noted that the prosthesis shown in FIGS. 8-9 may be modified with struts or other means for holding a suture in the manner shown in FIGS. 5-7. Although described here with reference to the human heart, it will be apparent to those skilled in the art that a prosthesis in accordance with the present invention may be adapted to repair other types of valves by making suitable adjustments to the shape and size of the device and to the disposition of its components so that it is able to coapt with an opposing valve leaflet. Various modifications and changes to the embodiments that have been described can be made without departing from the scope of the present invention, and will undoubtedly occur to those skilled in the art. The invention is not to be construed as limited to the particular embodiments and should be understood as encompassing all those embodiments that are within the spirit and scope of the claims that follow. Referenced byCiting PatentFiling datePublication dateApplicantTitleUS7695511 *Sep 12, 2007Apr 13, 2010Drake Daniel HMethod and system for treatment of regurgitating heart valvesUS7704277Sep 14, 2005Apr 27, 2010Edwards Lifesciences AgDevice and method for treatment of heart valve regurgitationUS7785366Nov 15, 2007Aug 31, 2010Maurer Christopher WMitral spacerUS7879087 *Oct 5, 2007Feb 1, 2011Edwards Lifesciences CorporationMitral and tricuspid annuloplasty ringsUS8216303Nov 19, 2008Jul 10, 2012The Cleveland Clinic FoundationApparatus and method for treating a regurgitant heart valveUS8382828 *Dec 22, 2010Feb 26, 2013Edwards Lifesciences CorporationMitral annuloplasty ringsUS8460370Apr 15, 2010Jun 11, 2013Edwards Lifesciences AgDevice and method for treatment of heart valve regurgitationUS8480733 *Mar 4, 2011Jul 9, 2013The Cleveland Clinic FoundationApparatus and methods for repair of a cardiac valveUS8529620Apr 29, 2008Sep 10, 2013Ottavio AlfieriInwardly-bowed tricuspid annuloplasty ringUS8758430Jan 23, 2009Jun 24, 2014Jenavalve Technology, Inc.Medical apparatus for the therapeutic treatment of an insufficient cardiac valveUS8764829 *Jul 11, 2011Jul 1, 2014James MarvelBuffer for a human joint and method of arthroscopically insertingUS8784483 *Jan 4, 2012Jul 22, 2014The Cleveland Clinic FoundationApparatus and method for treating a regurgitant heart valveUS8894704Apr 23, 2013Nov 25, 2014Adam GroothuisSystems and methods for treating lumenal valvesUS8932348May 17, 2007Jan 13, 2015Edwards Lifesciences CorporationDevice and method for improving heart valve functionUS8968395Apr 4, 2012Mar 3, 2015Edwards Lifesciences CorporationProsthetic insert for treating a mitral valveUS8992605Jun 5, 2013Mar 31, 2015Edwards Lifesciences AgDevice and method for reducing mitral valve regurgitationUS20110093065 *Dec 22, 2010Apr 21, 2011Edwards Lifesciences CorporationMitral and Tricuspid Annuloplasty RingsUS20110112630 *Oct 6, 2010May 12, 2011Adam GroothuisSystems and methods for treating lumenal valvesUS20110153009 *Mar 4, 2011Jun 23, 2011The Cleveland Clinic FoundationApparatus and methods for repair of a cardiac valveUS20110270393 *Jul 11, 2011Nov 3, 2011James MarvelBuffer for a human joint and method of arthroscopically insertingUS20120179247 *Jan 4, 2012Jul 12, 2012The Cleveland Clinic FoundationApparatus and method for treating a regurgitant heart valveWO2009067519A2 *Nov 19, 2008May 28, 2009Cleveland Clinic FoundationApparatus and method for treating a regurgitant heart valveWO2010070649A1Dec 21, 2009Jun 24, 2010Mor Research Applications Ltd.Elongated body for deployment in a coronary sinusWO2011033508A1Sep 15, 2010Mar 24, 2011Transcardia Ltd.Heart valve remodelingWO2014108859A1 *Jan 10, 2014Jul 17, 2014Jacob ZeitaniDevice for plastic surgery of the mitral valveWO2014168655A1 *Nov 13, 2013Oct 16, 2014St. George Medical, Inc.Mitral heart valve prosthesis and associated delivery catheterWO2014195422A1 *Jun 5, 2014Dec 11, 2014Ladjali MustaphaDevice for treatment of body tissue, and associated treatment kit* Cited by examinerClassifications U.S. Classification623/2.36, 623/2.38International ClassificationA61F2/24Cooperative ClassificationA61F2/2448, A61F2/2454European ClassificationA61F2/24R6, A61F2/24R2DRotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services