Regulation 32 Revised 2/98 AUSTRALIA Patents Act, 1990 ORIGINAL COMPLETE SPECIFICATION TO BE COMPLETED BY THE APPLiCANT APPLICANTIS: Edwards Lifesciences Corporation INVENTORS: HAUSER, David L SOLEM, Jan Otto ALON, David ADDRESS FOR SERVICE: Peter Maxwell and Associates Level 6 60 Pitt Street SYDNEY NSW 2000 INVENTION TITLE: PROSTHETIC INSERT FOR IMPROVING HEART VALVE FUNCTION DETAILS OF ASSOCIATED APPLICATION NO(S): Divisional of Australian Patent Application No. 2007 266 448 filed on 31 May 2007 The following statement is a fuIl description of this invention induding the best method of performing it known to us: m:\docs\20071208\301498.doc 1 CROSS REFl3;mNCE TO RELATED~ A PLUCATYO O 1Th anncation claims the benefit of Us. Provisional patent 5 Application No, 60/810,85, fied June 1, 2006, which is incorporated herein by reference in its entirety. The disclosure relates to the field of implantable cardiac prosthetics and in particular, to a cardiac prosthetic insert for reducing regurgitation 10 through a heart valve, such as the aortic valve and to methods of implanting the cardiac prosthetic insert. BACKGROUND [0ON3) Heart valve regurgitation, or leakage from he outfow to the inflow side of a heart valve, is a condition that occurs when a heart valve fais to close 15 properly. Heart valve regurgitation decreases the eficiency of the heart, reduces blood circulation and adds stress to the heart hn early stages, heart valve regurgitation leaves a person fatigued and short of breath. If left unchecked, the problem can lead to congestive heart failure. arrlythias or death. 20 (00i4] Regurgitation through the a ortic valve, sometimes referred to as aortic insufficiency, is a serious problem that affects the health of millions of adults, The aortic valve is positioned on the let side of the heart between the lf ventricle and the aorta. A healthy aortic valve opens to allow blood to flow fiom the left ventricle into the aorta during ventricular systole and then 2 closes to prevent blood from flowing backward fom the aorta into e lft ventricle during ventricular diastole. However, over time, changes in te geometric configurations of the aortic annulus, o other causes such as calcification, infection and injury, may affect the functionality of the aortie 5 valve. As a result, the aortic valve may not close completely during ventricular diastole, thereby leading to regurgitation. 100fI5) Aortc insufficiency is typically treated by replacing the defective native valve with a prosthetic valve during open heart surgery. However, open-heart surgery is highly invasive and is therefore not an option for many 10 high risk patents, Accordingly, in recent years, less invasive methods, such as percutaneous valve replacement, have been developed for replacing aortic valves, In an example, a prosthesis including a stent and a valve is crimped into a small profile and Then delivered into the heart via a percutaneous route. Once located at the treatment site, the prosthesis is expanded to replace the 15 function of the native aortie valve. Although percutaneous valve replacement has shown great promise, there are still challenges with respect to delivery techniques, perivalvular leakage and durability of the valve. Furthermore, when possible, it may be desirable to repair, rather than replace, the native valve. 20 MM ['6t6] Accordingly, disclosed herein is a device and method of use for treating heart valve disease involving in exemplary embodiments, a rnmminally invasive procedure that does not require extracorporeal circulation. Certain embodiments of such a device and method desirably arc capable of reducing or 25 elminadng regurgitation through a heart valve. it is aso desirable that embodiments of such a device and method be weilsuited for delivery in a percutaneous or minimally-invasive procedure. t is also desirable that embodiments of such a device and method be well-suited for repairing an aortic valve. It is also desirable that such a device be safe, reliable and easy to deliver. It is also desirable that embodiments of such a device and method be 5 applicable for improving heart valve function for a wide variety of heart valve defects. It is also desirable that embodiments of such a device and method be capable of improving valve function without replacing the native valve. OOO Various embodiments of the present disclosure provide impro ved devices and methods for improving the function of a defective heart valve. 10 Particular embodiments can be configured to be implanted in a heart using a percutaneous or minimally invasive procedure wherein extracorporeal circulation is not required. [0008 i one representative embodiment of the present disclosure, a prosthetic dvice includes an anchoring member and an inser member 15 configured for deployment between the leaflets of a native valve, such as the aortic valve. The insert member is desirable shaped to fl the gaps between the leaflets for creating a tight seal during ventricular diastole and thereby minimizing or preventing regurgitation through the aoric valve, The insert member is desirable sized such that tie native leaflets engage the surfaces of 4S. the insert member. When configured for use with a typica aortic valve, the insert member desirable includes three arms extnding radially outward from a central region, Each of the ar-s is shaped for placement between adjacent leaflets of the aortic valve. The anchoring member is provided for securing the insert mn r ri its deployed position In exemplary embodiments, the 25 anchoring member takes the form of a stent configured for deployment in the ascending aorta. In one variation, the insert member can be configured (eg with two am-s) for use with an aortic valve having only two leaflets in -4 another variation, the isert member can be configured for use in a pulmonary valve for treating pulmonary insufficiency. fP09] In another representative embodiment of the present disclosure, a prosthetic device incldes an anchoring member formed of a stent and an insert 5 member configured for deployment between the laflets of a native sortic valve, The anchoring member desirable includes a valve member for providing unidirectional flow The anchoring member is desirable configured for delivery into an ascending aorta The stent is expanded, either by self' expansion or by balloon expansion, such that the stent is anchored in the aorta 10 After deployment, the valve member in the stent prevents or minimizes blood from flowing backward through the aorta The insert member is delivered into the native aortic valve to improve the native valve function, Accordingly, two separate valves (e.g., stented valve and native valve) work in tandem for preventing regurgitation through the aortic annulus, By deploying the insert 15 member in the native valve, the native valve is allowed to function as it should and blood enters the coronary arteries in a substantially natural manner. The stented valve supplements the function of the native valve, if desired, the stented valve could be constructed to close bef or after desirabley after) the native valve to further influence and improve the native valve function and 20 also to improve herodynamics 199 *]In a representative embodiment a system and method are provided for treating a defective heart valve. The system includes a prosthete device including an anchoring member and an insert member, The system further includes a delivery catheter for delivering the prosthetic device into the heart 25 via a percutaneous approach. The delivery catheter desirable includes an elongate sheath having a lumen sized to receive the prosthetic device. In exemplary embodiments, the prosthetic device is held within the sheath in a WO 2007440470 PCT/US2007/070141 collapsed configuration during advancement through the subject's vasculature. in one variation, the sheath is configured for retrograde advancement and may be configured with a deflectable end portion for facilitating navigation around the aortic arch. After reaching the treatment site, the sheath is moved S proximally relative to the prosthetic device to eject the device from the sheath. The device is then allowed to expand such that the insert Conforms to the gaps in the aortic valve and the anchoring member engages the inner wal of the aorta, 10 in another representative embodiment of the present disclosure, a 10 prosthetic device includes an anchoring member and an insert member having three expandable ans configured for deployment between the gaps in an insufficient aortic valve. Each arm desirable includes an expandable region that opens in a manner somewhat similar to a parachute for preventing regurgitation. LDuring venricular systole each expandable region collapses 15 such that the flow of blood through the aortic valve is not impeded. 10P In a certain representative embodiment of the present disclosure, a prosthetic device includes an insert member configured for deployment within an aortie valve and an anchoring member configured for securement within the left ventricle. An elongate body portion is provided for coupling the insert 20 member to the anchoring member. If one variation, the prosthetic device can be delivered in multiple stages. In a first stage, the anchoring member is delivered and is then allowed to grow into the heart wall. After sufficient in growth has occurred, in a second stage, the insert member is attached to the anchoring member. 25 {0 3Z in another representative embodiment of the present disclosure, a prosthetic device includes an anchoring member and an insert member -6 configured for deployment between anterior and posterior leaflets of a mitral valve. The insert member is desirably shaped to fill the gap between native leaflets for preventing regurgitation through the nitral valve. The insert member is sized such that the mitral valve leaflets engage the surfaces of the 5 insert member to create a tight seal during ventricular systole. In a variation of this embodiment, one or more passageways are provided through the insert member for allowing blood to flow through the device in one direction to further improve valve function. 001 4 The foregoing and other features will become more apparent from 10 the following detailed description of several embodiments, which proceeds with reference to the accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS [N M5] FIG. I illustrates a cross-sectional view of a heart. 100161 FIG. 2 is a perspective view of a prosthetic device including an 15 anchoring member and an insert member configured for deployment between leaflets of a native aortic valve. 1017] FIG. 3 is a cross-sectional view of an insert member with an outer coating of biocompatible material. [0018 FIG. 4 is a cross-sectional view of the insert member of FIG. 2 20 positioned in an aortic valve. 0, 9} FIG. 5 is a partial cut-away view of the aorta illustrating the prosthetic device of FIG. 2 deployed within a subject to treat aortic insufficiency.
~7 [00201 PIG. 6 is a perspective view illustrating an embodiment of a prosthetic device wherein the insert member is directly attached to the anchoring member. 'H211 FrG. 7 is a cro0ssectional view of the insert member of FIG. 6 5 contained within a sheath in a contracted condition for delivery to a treatment site. 136221 FiG. 8 illustrates the insert member of FIG. 6 after being ejected from the sheath and expanding into an expanded condition. ji23J FIG. 9A is a perspective view of a prosthetic device including an 10 insert member for deployment in the aortic valve and an anchoring member with engagement members for securement to the left ventricle. [024] FIG. 9B is an exploded view of an. exemplary embodiment of a plurality of engagement members shown in an expanded state. [002f5 FIG. 9C is a perspective view of the plurality of engagement 15 members of FIG. 9B shown in a compressed state for delivery to the heart. [0026 FIG. 10 is a variation of the embodinient shown in FIG. 9A wherein an alternative anchoring member is provided. W271 FIG. II is a perspective view of a prosthetic device similar to the embodiment illustrated in FIG. 2 wherein the anchoring member includes a 20 stent and a valve member for deployment in the ascending aorta. [0PM) F<IG. i2 is a perspective view of a prosthetic device similar to the embodiment illustrated in. FIG. 2 i which the insert member is formed with two arms.
[029j FIG0 13 is a perspective view of a prosthetic device including an anchoring member and an insert member deplovcd in a heart for treating an insufficient mitral valve [03] FIG. 14 is a cross-sectional view of the insert member of FIG. 13, 5 0 FIG. 15 is a cross sectional view illustradng an insert member forned with a passageway and valve member for auowing blood to flow through the insert member in one direction. DETAILED DESCRPION OF SEVERAL EMBODIMENTS 10 [f&32I I Explanation of Terns pOO3is Unless otherwise noted, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skil in the art to which this disclosure belongs. In order to facilitate review of the vadous embodiments of the disclosure, the following explanation of terms 15 is provided: O{34I The singular terms "a", "an", and "the" include plural referents unless context clearly indicates otherwise. The term "or" refers to a single element of stated alternative elements or a combination of two or more elements, unless context clearly indicates otherwise. 20 9035 The term "includes" means comprisess" For example, a device that includes or comprises A and B contains A end B, but may optional contain C or other components other than A and 13. Moreover, a device that .9 includes or comprises A orBmay contin A or or A and Bad optionally one or more other components, such as C, L0S6] The term proximall" refers to a portion of an instrument closer to an operator, while "distal" refers to a portion of the instrument farther away 5 from the operator. f00t7j The term "subject" refers to both human and other animal suject n certain embodiments, the subject is a human or other mammal, such as a primatecat, dog, cow, horse, rodent, sheep, goat, or pig. In a particular example the subject is a human patient. 1 0 O38 Although methods and materials similar or equ ivaient to those described herein can be used in the practice or testing of the present disclosure. suitable methods and materials are described below. In case of conflict, the present specification, including terms, will control. In addition 5 the materials, methods, and examples are illustrative only and not intended to be ihiting. r0391 I1 An anatomical overview /Fthe human heart 9040]J With reference to FG. I1, a cross- sectionaview of a heart i is provided. Blood fows through the superior vena cava 2 and the inferior vena cava 4 into the right atrium 6 of the heart 1. The tricuspid valve 8 controls 20 blood flow between the right atrium 6 and the right ventricle 15, The tricuspid valve 8 is closed when blood is pumped out from the right ventricle 15 to the lungs. Thereafter, the tricuspid valve 8 is opened to refill the right ventricle 15 with blood from the right atrium 6. Free edges of leaflets of the tricuspid valve 8 are connected via the chordae tendinae 10 to the papillary muscles 12 in the - 10 right ventricle 15 for controling the movements of the tricuspid valve 8. Blood from the right ventricle 15 is pumped through the pulmonary valve 20 to the pulmonary artery 22, which branches into arteries leading to the lungs, 0jhP4 After exiting the lungs, the oxygenated blood flows through the 5 pulmonary veins 28 and enters the left atrimi 26 of the heart L The mitral valve 30 controls blood flow between the left atrium 26 and the left ventricle 17. The mitral valve 30 is closed during ventricular systole when blood is ejected from the left ventricle 17 into the aorta 34. Thereafter, the mitral valve 30 is opened to refill the left ventricle 17 with blood from the left atrium 26. 10 Free edges of leaflets of the mitral valve 30 are comected via the chordae tendinae 11 to the papillary muscles 13 in the left ventricle for controlling the movements of the mitral valve 30. Blood from the left ventricle 17 is pumped through the aortic valve 32 into the aorta 34 which branches into arteries leading to all parts of the body. The aortic valve 32 includes three leaflets 15 (alo known as flaps or cusps) collectively denoted by reference numeral 36. Leaflets 36 open and close to control the flow of blood into the aorta 34 from the left ventricle 17 of the heart as it beats. $f042j Hl Prosthetic Device Jbr reducing regurgitation through a heart valve 20 10{43] The efficiency of the heart may be seriously impaired if any of the heart valves is not functioning properly. For example, heart valves may lose their ability to close properly due to dilation of an annulus around the valve or a fladd, pzolapsed leaflet. The leaflets may also have shrnk due to disease, such as rheumatic disease, thereby leaving a gap in the valve between the 25 leaflets. The inability of the heart valve to close will cause blood to leak backwards (opposite to the noral flow of bood), commonly referred to as regurgitation, through the aortic vale into the left ventricle, Regurgitation may seriously impair the function of the heart since more blood will have to he pumped through the regurgitating valve to maintain adequate circulation. [9541 Embodiments of the present disclosure provide devices and 5 methods for improving the function of a defective heart valve, such s an aortxc valve. The devices and methods disclosed herein are desirable delivered into a subjects heart using percutaneous or minima ly invasive surgical methods Accordingly, desirable delivery methods described herein do not require extracorporeal circulation (eg& blood fom a subject's circulation being routed 0 outside the body to have a process applied to and then, retuned of the subject's circulation). For example, in one embodiment, a delivery catheter (or similar delivery device) is iserted through an incision in the chest wall and then through the cardiac tissue (e g through the apex of the heart) into a chamber of the patient's beating heart. The delivery catheter can allow a prosthetic 15 device to be deivered into the heart in a collapsed configuration and then expanded within the heart for treating a defective heart valve. Because the desired delivery methods do not require extracorporeal circulation complications are greatly reduced as compared with traditional open-heart surgery. 20 100451 FIG. 2 illustrates an example of a prosthetic device 100 which can be employed to reduce or eliminate regurgitation through a heart valve, such as the aortic valve. The prosthetic device 100 includes an inser member 1 02 and an anchoring member 110. The insert member 102 desirable includes a solid outer surface for contacting native valve leaflets, such as the native aortic valve 25 leaflets. As used herein, a "solid" surface refers to a nonperforated surface that does not include any openings through which blood can pass. As illustrated in F 2, the insert member 102 includes a first extension portion, -12 or arm, 104, a second extension portion, or arm, 106 and a third extension portion, or arm, 108. The extension portions 104, 106, 108 desirably are equally angularly-spaced about a central portion 112 of the insert member 102 and extend radially outwardly therefrom, The prosthetic device 100 can 5 include a plurality of spacers or connecting mrnembers 120 for mounting the insert member 102 at a position spaced from the anchoring member I10. As shown in FIG. 2, three such spacers or connecting members 120 are provided in the illustrated embodiment for coupling the insert member 102 to the anchoring member 110. 10 [90461 In the illustrated embodiment, the anchoring member 110 takes the form of a self-expanding or balloon-expandable stent having an open-frame construction as depicted in FG. 2. The anchoring member can be made of various suitable expandable and/or elastic materials, such as stainless steel, titanium, shape memory alloys, or other biocompatible metals. In one 15 example, the anchoring member 110 is self-expanding and formed of shape memory alloys, such as nickel titanium (NiTi) shape memory alloys, as marketed, for example, under the trade name Nitinol. In another example, the anchoring member 110 is balloon-expandable and formed of stainless steel or other suitable materials. 20 [W0471 In particular embodiments, the anchoring member I 10 comprises a stent having a plurality of angularly-spaced axial struts, or support members, that extend axially (longitudinally) of the member, The anchoring member I10 can also include a plurality of axially-spaced, circumferential bands, or struts, attached to the axial struts. The circumferential struts are formed with 25 multiple bends that allow the anchoring member 110 to be compressed to a smaller diameter for delivery to an implantation site and expanded to its functional size for anchoring the insert member 102 to the heart. The 13 circumferential struts can include a plurality of linear strut members arranged in a zig-zag or saw-tooth configuration defining bends between adjacent strut members. In other examples, one or more of the circumferential bands can have a curved or serpentine shape rather than a zig-zag shape. In variations, 5 the anchoring member I 10 may further include fixation or attachment members, such as barbs, staples, flanges. hooks, and the like along the exterior of the anchoring member I10 for enhancing the ability of the anchoring member 110 to anchor insert member within the aorta. Further details of exemplary stents that can be employed in the embodiments disclosed herein 10 are disclosed in U.S. Patent No. 6,730,118, US, Patent No. 6,767,362, and U.S. Patent No. 6,908,481, each of which is incorporated herein by reference in its entirety. [0048j Although the anchoring member is primarily described in the form of a stent, it will be appreciated that a wide variety of anchoring mechanisms 15 may be used while remaining within the scope of the present disclosure. For example, the anchoring member can be formed by one or more retainers, In a particular example, the anchoring member can be a plurality of spaced-apart retainers that extend outwardly to contact tissue near or within the heart valve annuhis. The retainers are sized and configured to secure the body to the heart 20 valve annulus. For instance, the one or more retainers can be circuiar bands formed of polyethylene, polypropylene, polycarbonate, nylon, polytetrafluoroethylene, polyurethane, stainless steel, Nitinol, titanium, polyimide, polyester. shape-memory material, or a mixture thereof. The one or more retainers can include protrusions, barbs, needles, hooks, and like 25 engagement members for assisting with anchoring the prosthetic device within the heart valve.
- 14 a ow49 The insert member 102 is configured fbr insertion between the leaflets of an insuffcient aortie valve so as to fill the gap between the leafets in one speciic example, the insert member 102 exhibits suffeient rigidity to substantially maintain its deployed shape and is resilient and/or flexible 5 enough to be compressed to a reduced diameter for delivery in a delivery sheath. The insert member can be fonned from plastic, metal (eg., shape memory metal) or other bioconpatible material suitable for implantation into a subject. in particular examples, as illustrated in FIG. 3, the insert member 102 can include an inner support layer 127 and an outer layer or sheath 128. The 10 outer layer 128 can be formed of a biocompatible material; such as a clothlike or fabric material (natural or synthetic) or a biological material, such as collagen or biological tissue material in order to protect the native leaflets from damage (e.g, to inhibit abrasion that could occur in response to engagement and disengagement of the leafets). For instance, smooth animal pericardium 15 such as equine, bovine, porcine or other animal pericardial tissue which is compatible Wth the native leaflets may be included within the outer layer 128, Such tissue may be tanned or fxed by a suitable tanning environment or the pericardium can be cross-linked with giutaraldehyde and heparin bonded by a detoxification process. In a certain example, the biological tissue material can 20 be one of the NO- REACTnatural tissue producs exhibit improved biocompatibility and mitigate calification and thrombus formation. The outer layer 128 can cover the entire outer surface of the inner layer 127 or selected portions of the outer surface, such as those portions that come into contact with the native leaflets. 25 [0050j in certain examples, the diameter of the in sert member 100. is similar to the diameter of the native aorie valve such that each of the extension portions extends imo a cusp between leaflets in the aortic valve. As a resul, the insert member 102 of the device 100 remains centered within the artic valve after deployment, In certain examples, the diameter of the insert member is about 18 mm to about 26 mn, with about 22 mm being a specific example. The diameter of the insert member 102 can be slightly smaler as 5 compared to the diameter of the anchoring member 110. This configuration allows the insert member to collapse or folddawn to a reduced diameter for delivery in a delivery sheath. Additionaly, theength of the insert member can vary. For example, in one embodiment, the length of the insert member is approximately the same size as the length of the anchoring member n otter 10 examples, the length of the insert member is greater or smaller than that of the anchoring member. In certain examples, the length of the insermember is about 20 mm to about 30 mm, with about 25 mm being a specific example. [0G5JG As illustrated in FIG. 4, the cross-sectional profhle of the insert member 102 can be shaped such that the native leaflets 36a, 36b 36e are 15 capable of contacting the sides of the insert member 102 to create a tight seal during ventricular diastole. For example, the three spaced apart extensions or arms 104, 106 and 108 extend radially outward from a central region 112 of the insert member 102. In certain examples, the arms taper in width from the central portion to the outer ends of the extension portions. For example, each 20 arm includes a first end 114 and a second end 116. The first end 114 is of a greater width than the second end 116. The arms each include a first side 122 and a second side 124, each of which side is configured for contact with a native leaflet. The ends 114, 116 and the sides 122, 124 can be configured with smooth edges to minimize or e iinate hemolytic effects Further, each 25 of the arms is configured to fill a gap between adjacent leaLets of an aortic valve, thereby preventing regurgitation through the aortic valve, The contact surfaces of the arms can exhibit suftcient compliancy and/or flexibility to -16 allow the native leaflets to engage the insert member 102 and create a tightsea without damaging the leaflets. For example, as described above, each arm can include bioconpatible material, such as collagen or pericardial tissue to inhibit abrasion that could occur in response to engagement or coaptation of the arms 5 with the native leaflets, 19)52J When used to treat an aortic valve, the cross-sectional profile of the insert member can be minimized to limit resistance to blood flow from the le ventricle into the aorta when the aortic valve is fully open. Furthermore, one or both ends of the insert member may be tapered or rounded such that there are no flat surfaces facing perpendicular to the flow of blood. With respect to the illustrated embodiment, it will be appreciated that the prosthetic device is capable of minimizing or preventing regurgitation without utilizing any moving parts. The device can therefore achieve greater durability as compared with alternative heart valve repair and replacement techniques that utilize 15 moving parts. [033 The insert member 102 can be configured with expandable structures, such as moveable flaps, to further impede regurgitation through the aortic valve. Each expandable structure can be configured to fill a gap between adjacent native valve leaets. In one example, the movable fl a ps can 20 be configured to open in a manner similar to that of a parachute to block regurgitation of blood between the leaflets of the native aortic valve. During ventricular systoic. the moveable flaps collapse to allow blood to flow from the left ventricle, through the native aoric valve and into the aorta in a substantially unimpeded manner. Additional details regarding an expandable 25 insert member (egg, valve portion) can be found in Applicant's copending US Application No. 1/407,582U8Patent Pubiication No. 2006/0241745) filed on April 19, 2006, which is hereby incorporated by reference in its - 17 entirety. Principles and features of the expandable prosthedc devices described in the '582 Application, which are configured for use with a mitral valve, are also applicable to the devices described herein for use in the aortic valve. M 54 As mentioned above and as illustrated in FIG. 2, the prosthetic 5 device 100 includes a plurality of spacers or connecting members 120. Each connecting mewher can be generally cylindrcal in shape, alhough any other suitable shape may be employed. Ir certain examples, the length of each connecting member is about 6 mm to about 14 mm, with about 10 mm being a specific example. Each connecting member preferably couples an arm of the 10 insert member 102 to the anchoring member 110. The connecting members 120 can assist in stabilizing theinsert member 102. Each connecting member desirably exhibits sufficient rigidity to substantially maintain the insert member in a fixed position relative to the anchoring member, The connecting members can be fonned of plastic, metal or other biocompatible material 15 suitable for implantation into a subject, The *onnecting members 120 also minimize interference of the prosthetic device with blood flow to the coronary arteries by allowing the anchoring member 110 to be positioned above the coronary osia and the insert member 102 positioned in the native aortic valve. [e9501 As best illustrated in FIG. 4, the native leaflets 36a, 36b, 36c of the 20 aortic valve 32 contact the insert member 102 during vent icular diastole to create a tight seal. By allowing the aPrtic valve 32 to create a tight seal, regurgitation from the aorta into the lef ventricle is minimized or prevented. During ventricular systole, the native leaflets open as'they do natural to allow blood to be pumped from the len ventricle into the aorta. As can be seen in 25 FG. 4, the cross-sectional area of the iwi member 102 relatively small as compared with the flow area through the aortic annulus. Accordingly, in the 18 illustrated embodiment, the insert member 102 will not substantially impede the flow of blood through the aortic valve during venLtricula systole. 0056j With reference to FIG. 5, the prosthetic device 100 is illustrated after deployment within a subject. As illustrated in FIG, 5, the anchoring 5 member 110 is deployed in the aorta above the aortic valve, such as above the ostia of the coronary arteries 38 such as to not interfere with the flow of blood through the coronary arteries. The insert member 102 is deployed within the native aortic valve to improve the function of the aortic valve. For example, the insert member 102 is positioned within the native aortic valve with each 10 arm 104, 106 and 108 extending between adjacent edges of two leaflets such that the leaflets of the aortic valve 32 coapt with the arms 104, 106 and 108. The connecting members 120 extend from the anchoring member 110 to the insert member 102 for maintaining the insert member 102 in a substantially fixed position. During ventricular diastole, the leaflets of the aortie valve 32 15 close and press against the walls of the insert member to create a tight seal, Although the native leaflets in an insufficient or defective aortic valve may not be able to close completely, the arms of the insert member 102 fill the gaps such that little or no blood is allowed to pass from the aorta back into the left ventricle. 20 [0957] As shown, the native aortic valve is not excised and continues to function in a substantially normal manner. As a result, over time, it may be possible to remove the prosthetic device if the native valve is able to heal itself or if an alternative treatment is found. M0581 With reference to FIG 6, a prosthetic device 200 according to 25 another embodiment is shown. Prosthetic device 200 includes an insert member 102 and an anchoring member 110. The insert member 102 in the -19 illustrated embodiment is directly coupled to the anchoring member 10 rather than via the connecting members 120, For example, the insert member can be coupled to the anchoring member 110 via the proximal end 118 of the insert member 102, for example with the proximal end of the insert member 102 5 re elved partially within and surrounded by an end portion of the anchoring member 110. The diameter of the insert member 102 in the illustrated embodiment is less than the diameter of the anchoring member 110. This configuration allows the insert member 102 to be collapsed or folded during implantation, and then deployed within the valve, 10 [9159 The disclosed prosthetic devices can be configured to be delivered in a perctaneous or minimally invasive procedure in which only a smal access incision is required. In one example, the prosthetic device can be configured so that it can be crimped or otherwise collapsed into a smaller profile and then placed in a delivery sheath for advancement to the treatment 15 site. FIG. 7, for example, illustrate a prosthetic device 200 in a collapsed condition within a sheath 142. As shown, the insert member 102 can be configured to be sufficiently flexible such that the arms can be folded or caused to assume a curved profile to temporarily reduce the prone of the insert during delivery. After being ejected frm the sheath 142. the anchoring 20 member 110 and insert member 102 expand to a filly expanded condition as shown in FWE When delivered to the aortie valve in a percutaneous procedure, it may be dedrable to utilize a delectable sheath to faciitate navigation though the patients vasculature and around the aortic arch, Details regarding various embodiments of a deflectable sheath configured to 25 deliver a therapy device to an aortic valve can be found in Applicant's co peiding U.S. Application No. 1 1 52288, filed June 13, 2005, entitled "Heart e20 Valve Delivery System," which is hereby incorporated by reference in its entirety. t06O OA illustrates a prosthetic device 300 that can ben sed to reduce or eliminate heart valve regurgiation, such as aortic valve 5 regurgitation. In this embodiment, the prosthetic device includes an insert member 102 configured for insertion into the aortic valve and an anchoring member 302 configured for securement to the muscular wall in the left ventricle. The anchoring member 302 can include a plurality of engagement members 304, such as hooks or fingers, that penetrate tissue along the 10 muscular wall for securing the insert member 102 to the heart, The engagement members 304 can be formed of any biocompatible material, such as biocompatible metals or plastics, which is capable of penetrating the left ventricle muscular wall to secure the insert member 102 to the heart without substantially iimpairing the wall. The anchoring member 302 can include an 15 elongate body portion, or shaft, 306 which couples the engagement members 304 to the insert member 102. In one example, the elongate body portion 306 and the engagement members 304 can be formed from a single piece of material. In another example, the elongate body portion 306 and the engagement members 304 can be separately formed and subsequently coupled 20 to one another by any suitable means, such as welding, The elongate body portion 306 and the engagement members 304 can be formed of the same or different materials depending on the material properties (elasticity, rigidity, resilience and the like) desired for each part of the device 300. h9h6P' The prosthetic device 300 can be positioned within he heart to 25 minimize aorti valve regurgitation by positioning the plurality of engagement members 304 in the left ventricle near the left ventricular apex. In he illustrated embodiment, a plurality of fingers or hooks penetrates tissue along -21 the left ventricle muscular wall near the left ventricular apex. The insert member 102 is positioned in the aortic valve annuus such that an upper portion and lower portion extend above and below the nadve aortic valve and the arms of the insert member 102 are aligned with coaptions of thethree cusps 5 of aortic valve so each leaflet moves up and down between the insert arm. WG62j FIGS. 9B and 9C illustrate the lower end portion of an anchor member 302 with a plurality of engagement rnembers 304 in the form of elongated prongs. The elongated prongs 304 are desirable configured to self expand from the compressed configuration of FIG. 9C to a "flowered" or 10 expanded configuration of FIG. 9B when advanced out of a delivery sheath This flowering is desirably achieved with a self curving area 304a that deflects the prongs 304 radially outward from the center of the body 502 and rearward toward the second end of the body. The prongs 304 are desirable pointed or barbed to facilitate penetration and engagement with the muscular wall of the 15 heart. [0063] The anchor member 302 can be formed from a single tube of shape memory material, such as, for example, Nitinol During manufacture, the shape memory material may be cut using a mechanical or laser cutting tool Afer cutting the tube, the expanded or flowered shape can be imparted to the 20 memory of the shape memory material with techniques known in the art (e.g. heat setting the shape). Methods for manufacturing the anchor member are described in detail in Applicant's co-pending U. Application No. 11/750,272 (hereinafter "the '272 application"), which is incorporated herein by reference. In one preferred embodiment, the anchor member is formed to have an 25 expanded configuration that conforms to the contours of the particular surface area of the heart where the anchor member is to be deployed, as described in the '272 application - 22 0t64j The surface of the anchor member 302, inch ding the prongs 304, is desirably configured to promote tissue growth onto and even into its surface. In one example this growth is achieved by providing the anchor member with a relatively rough and/or porous surface. Additionally, biological coatings of the 5 types known in the art can be included on the surface of the anchor member 302 to promote healing and tissue growth. IO0&6J FIG. 10 illustrates another variation of an anchoring member 402 wherein one or more anchors, such as the illustrated plates 404, are located on opposite sides of the muscular wall of the heart for anchoring the prosthetic 10 device 400 to the heart The plates 404 can be fonned of any biocompatibie material, such as biocompatible metals or plastics. The anchoring member 402 includes a shaft 406 having an upper end portion connected to the insert member 102 and a lower-end portion that extends through the wall of the heart. One plate 404 is disposed on the shaft inside the lft ventricle and another plate 15 404 is disposed on the shaft outside the left ventricle to secure the shaf in place. 100661 If desired, the prosthetic device may be deployed in multiple stages wherein, in a first stage, the anchoring member is attached to the aorta (or ventricular wall) before the insert member is delivered, In a second stage, the 20 insert member of the device is connected to the anchoring member at a later time (e.g, hours, days or weeks later). The time between the first and second stages advantageously allows tissue to heal and even grow over the anchoring member, thereby turther embedding the anchoring member in the heart Without the added stress that the insert member of the device may impart on 25 the issue, the healing and over-growth may proceed nmore rapidly with less adverse affects (eg." unwanted scarring). Additional details regarding exemplary anchoring members, pandable insert members and tweostage deployment can be found in the '272 application. 0067) FiG 11 shows another alternative embodiment of a prosthetic device, indicated at 500. The anchoring member 110 can be a stent and can 5 include a valve member 130 mounted inside the stent. In the illustrated embodiment, the valve member 130 is a three-leafet bioprosthetic valve. In particular examples, the anchoring member and valve member may take the form of the Cribier-Edwards valve manufactured by Edwards ifesciences of Irvine, California. Additional details regarding exemplary embodiments of a 10 stented valve can be found in U.S. Patent No. 6,893460, which is hereby incorporated by reference in its entirety. [906$I The valve member 130 in the stent ensures unidirectional flow through the stent. The stent is desirable confgured tbr delivery into an ascending aorta. The stent is expanded, eiher by self-expansion or by balloon 15 expansionsuch that the stent is anchored in the aorta. Afer deployment the valve member in the stent prevents blood from flowing backward through the aorta. The insert member is delivered into the native aortic valve to improve the native valve funtion. Accordingly, two separate valves (i.e, the stunted valve and the native valve) work in tandem for inhibiting regurgitation through 20 the aertic annulus. By deploying the insert member in the native valve, the native valve is allowed to function as it soul and blood is allowed to flow into the coronary arteries in a substantialy natural manner. The stented valve supplements the function of the native valve, lf desired, the stented valve could be constructed to close before or afer the native valve to further 25 influence and improve the native valve function and also to improve hemiodynamics and/or perfusion into the coronary arteries - 24 M0691 With reference to FG 12, a prosthetic device 600 according to yet another embodiment is provided. The prosthetic devce 600 is configured for use in an abnormal aortic valve having only two leaflets. To treat this portion of the population, an insert member 602 is provided with two arms 604, 606 5 for filling the gaps between the leaflets. In addition in certain aortic valves having three leaflets, it may not be necessary to fill gaps between each of the three leaflets. Accordingly, it may be desirable to use an insert member of the type shown in I.1 12 for preventing or reducing regurgitation in a three leaflet valve. il0 NP0ll For purposes of illustration, desirable embodiments of a prosthetic device have been described above for use in a valve noraly having three leaflets, such as an aortic valve. However, it will be recognized by those o ordinary skill in the art that variations of the devices may also be used to real another valve with three leaflets, such as a pulmonary valve, in an analogous 15 manner. When used to treat the pulmonary valve 5 the anchoring member (e.g, stent) can be configured for deployment in the pulmonary trunk or a pulmonary artery Alternatively, the anchoring member may be secured within the right ventricle 007W With reference now to FIGS. 13 through 15, a prosthetic device 700 20 is configured for treating a bicuspid valve, such as a defective mitral valve. As lustrated in flG 13, the prosthetic device 700 includes an insert member 702 and an anchoring member 704 The insert member 702 comprises a body sized and shaped to fill the gap between the anterior and posterior laflets of an insufficient mitral valve. 25 iU'77] In one specific example, the insert member 102 exhibits sufficient rigidity to substially maintain its deployed shape and is resilient and/or flexible enough to be compressed to a reduced diameter for delivery in a delivery sheath The insert member can be firmed from plastic, metal or other biocompatible material suitabe for implantation into a subject. In particular examnples. as described previously, the insert member can include an outer 5 layer or sheath substantially formed of a biocompatible material, such as a cloth-Eke or fabric material (natural or synthetic) or a biological material such as collagen or biological tissue material in order to protect the native leaflets from damage (e.g., to inhibit abrasion that could occur in response to engagement and disengagement of the leaets). For instance, smooth animal 10 pericardium such as equine, bovine, porcine or other animal pericardi tissue which is compatible with the native leaflets may be included within the ouer layer. Such tissue may be tanned or fixed by a suitable tanning environment or the pericardium can be cross-inked with glutaraldehyde and heparin bonded by a detoxif'eation process, in a certain example, the biological tissue material 15 can be one of the NO-REACT natural tissue products exhibit improved biocompatibility and mitigate calcification and thronbus formation. The outer layer can cover the entire outer surface of the insert member 102 or selected portions of the outer surface, such as those portions that come into contact with the native leaflets. The insert member 702 can be shaped with tapered and/or 20 smooth edges to minimize or eliminate hemolytic effects. [07?4 The crossectional prone of the insert member 702 is shaped such that the native leaflets are capable of contacting the sides 703a and 703b of the inser nember 702 to create a tight seal. As lustrated in FiG-S. 13-15, the inser member 702 preferably has a cres ent-shape cross-sectional profile to 25 bette conform to the curvature of the native leaflets. The surface of the insert member 702 can be of a compliancy that allows the native leafets to engage the insert member 702 o create a tigit seai without damaging the leafets. For -26 exampk, as described above, the surface can comprise a biocompatible material, such as colagen or pericardial tissue to inhibit abrasion that could occur in response to engagement or coaptation of the insert member surface with the native leaflets, In operation, the native leaflets of the mitral valve 5 press against the walls of the insert member dining ventricular systole to create a tight seal and prevent regurgitation ofblood from the let venricle into the left atrium. [09714 In the illustrated embodiment, the anchoring member 704 of the prosthetic device 700 includes a shaft or elongated body portion 706, he lower 10 end Portion of which forms a penetration member 708- Plates 709 can be disposed on the penetration member 708 on opposite sides of the heart wall to secure the shaft in place. The body portion 706 and penetration member 708 of the anchoring member 704 may be of any suitable shape and material that imparts the material properties (elsa iity, rigidity resiience and the like) 5 desired for each part of the device 7001 For example, the penetration member 708 can be formed of any incompatible material, such as biocompatible metals or plastics, which is capable of penetrating the left ventrile muscular wail to secure the insert member 702 to the heart without substantially impairing the wall. 20 ON In one example the anchoring member 704 may be configured for deployment in the left ventriele. FG. 4 is a crosssectional view of the insert member 702 shown in FI. 13 In this embodiment, the insert member 702 can have a sbstantialy solid cross-section. in a variation as- shown in FIG. 15, theinsert member 702 may include a passageway extending along a 25 longitudinal axis, The passageway can be adapted to allow blood to flow through thelinsertmember in one direction A valve raember can be included within the insert to ensure that blood flows in only one direction. In a + 27 particular example, the valve member can comprise one or more flap members 712 defining a slit or opening 710. The valve member mimics the function of the target valve by allowing blood flow in only one direction. Thus, blood flow passing into the passage from one direction opens the flaps and thereby 5 passes through the insert member while blood moving into the passage from the opposite direction is stopped by the valve. 100761 IV System and Methods for reducing regurgitalion through a heart valve [00771 Disclosed herein are a system and methods for treating a defective 10 heart valve. In one embodiment, the system includes a prosthetic device including an anchoring member, such as a self-expandable anchoring member, and an insert member. The system can further include a delivery catheter for delivering the prosthetic device into the heart via a percutaneous approach. For example, the catheter can be introduced percutaneously into the patient's 15 vasculature (e.g., into a peripheral artery such as the femoral artery) and advanced to the implantation site. In certain embodiments, for example, the caheter is sized for insertion through a small incision in the groin and has a length of at least about 80 cm, usually about 90-100 cm, to allow transluminal positioning of the shaft from the femoral and iliac arteries to the ascending 20 aorta in a retrograde approach. Alternatively, the catheter may have a shorter length, e.g. about 20-60 cm, for introduction through other insertion points, such as, for example, the iliac artery, the brachial artery, the carotid or the subclavian arteries. In the femoral approach, the catheter desirable is long enough and flexible enough to traverse the path through the femoral artery, 25 iliac artery, descending aorta and aortic arch. At the same time, the catheter desirably has sufficient pushability to be advanced to the ascending aorta by pushing on the proximal end, and has sufficient axial, bending, and torsional - 28 stiffness to allow the physician to control the position of the distal end, even when the catheter is in a tortuous vascular structure. Alternatively, the catheter may be passed through a port between ribs. In one technique, the catheter is advanced through the patient's thorax above the heart and through an incision 5 in the aortic arch, in a so-called minimally-invasive procedure. in another technique, the catheter is advanced through an incision in the heart wall, preferably along the apex of the heart. The prosthetic device is advanced to the heart valve that is to be treated, and it is positioned to extend across the valve with the arms of the device interposed between the leaflets such that the 10 leaflets of the valve close and press against the walls of the insert member to create a tight seal. [0078] In certain embodiments, the delivery catheter includes an elongated sheath having a lumen sized to receive the prosthetic device. The prosthetic device is held within the sheath in a collapsed configuration during 15 advancement through the subject's vasculature. For example, during advancement to the left ventricle, the device is initially contained within the delivery sheath with the anchoring member retained in a radially compressed state. In one variation, the distal portion of the delivery sheath is configured for retrograde advancement and may be configured with a deflectable end 20 portion for facilitating navigation around the aortic arch, After reaching the treatment site, the sheath is moved proximally relative to the prosthetic device to eject the device from the sheath. The device is then allowed to expand such that the insert conforms to the gaps in the aoric valve and the anchoring member engages the inner wall of the aorta. 25 f079j Although embodiments of the present invention are preferably configured for percutaneous or minimally-invasive delivery procedures, in certain situations, the insert member may be deployed via an open-heart surgical procedure. In these embodiments, a delivery catheter may not be necessary since the defective native valve can be direcdy accessed. [cusp Although the cdiosure has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this 5 teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilate comprehension of the disclosure and should not be construed to limit the scope thereof