Source: https://patents.google.com/patent/AU2007266448B2/en
Timestamp: 2019-07-20 04:28:41
Document Index: 305993457

Matched Legal Cases: ['Application No. 60', 'art 25', 'art 1', 'art 1', 'art 1', 'art 20', 'Application No. 11', 'Application No. 11', 'art 7532', 'Application No. 11', 'art 7532']

AU2007266448B2 - Prosthetic insert for improving heart valve function - Google Patents
AU2007266448B2
AU2007266448B2 AU2007266448A AU2007266448A AU2007266448B2 AU 2007266448 B2 AU2007266448 B2 AU 2007266448B2 AU 2007266448 A AU2007266448 A AU 2007266448A AU 2007266448 A AU2007266448 A AU 2007266448A AU 2007266448 B2 AU2007266448 B2 AU 2007266448B2
AU2007266448A
AU2007266448A1 (en
2007-12-06 Publication of AU2007266448A1 publication Critical patent/AU2007266448A1/en
2013-07-18 Publication of AU2007266448B2 publication Critical patent/AU2007266448B2/en
2013-10-15 Priority claimed from AU2013245451A external-priority patent/AU2013245451A1/en
WO 2007/140470 PCT/US2007/070141 PROSTHETIC INSERT FOR IMPROVING HEART VALVE FUNCTION CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of U.S. Provisional Patent 5 Application No. 60/810,085, filed June 1, 2006, which is incorporated herein by reference in its entirety. FIELD OF THE DISCLOSURE 100021 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 [00031 Heart valve regurgitation, or leakage from the outflow to the inflow side of a heart valve, is a condition that occurs when a heart valve fails to close 15 properly. Heart valve regurgitation decreases the efficiency of the heart, reduces blood circulation and adds stress to the heart. In early stages, heart valve regurgitation leaves a person fatigued and short of breath. If left unchecked, the problem can lead to congestive heart failure, arrythmias or death. 20 [00041 Regurgitation through the aortic 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 left side of the heart between the left ventricle and the aorta. A healthy aortic valve opens to allow blood to flow from the left ventricle into the aorta during ventricular systole and then 7532 LDOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 -2 closes to prevent blood from flowing backward from the aorta into the left ventricle during ventricular diastole. However, over time, changes in the geometric configurations of the aortic annulus, or other causes such as calcification, infection and injury, may affect the functionality of the aortic 5 valve. As a result, the aortic valve may not close completely during ventricular diastole, thereby leading to regurgitation. [00051 Aortic 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 patients. 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 aortic 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 SUMMARY [00061 Accordingly, disclosed herein is a device and method of use for treating heart valve disease, involving in exemplary embodiments, a minimally invasive procedure that does not require extracorporeal circulation. Certain embodiments of such a device and method desirably are capable of reducing or 25 eliminating regurgitation through a heart valve. It is also desirable that embodiments of such a device and method be well-suited for delivery in a 7532 IDOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 -3 percutaneous or minimally-invasive procedure. It 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. 100071 Various embodiments of the present disclosure provide improved 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. 100081 In one representative embodiment of the present disclosure, a prosthetic device includes an anchoring member and an insert member 15 configured for deployment between the leaflets of a native valve, such as the aortic valve. The insert member is desirably shaped to fill the gap(s) between the leaflets for creating a tight seal during ventricular diastole and thereby minimizing or preventing regurgitation through the aortic valve. The insert member is desirably sized such that the native leaflets engage the surfaces of 20 the insert member. When configured for use with a typical aortic valve, the insert member desirably includes three arms extending radially outward from a central region, Each of the arms is shaped for placement between adjacent leaflets of the aortic valve. The anchoring member is provided for securing the insert member in 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 (e.g, with two arms) for use with an aortic valve having only two leaflets. In 7532 1.DOC PVL-5901 PCT WO 2007/140470 PCT/US2007/070141 another variation, the insert member can be configured for use in a pulmonary valve for treating pulmonary insufficiency. [0009] In another representative embodiment of the present disclosure, a prosthetic device includes an anchoring member formed of a stent and an insert 5 member configured for deployment between the leaflets of a native aortic valve. The anchoring member desirably includes a valve member for providing unidirectional flow. The anchoring member is desirably 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 before or after (desirably after) the native valve to further influence and improve the native valve function and 20 also to improve hemodynamics. [00101 In a representative embodiment, a system and method are provided for treating a defective heart valve. The system includes a prosthetic 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 desirably 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 7532 1.DOC PVI-5901 PCT WO 2007/140470 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 5 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 wall of the aorta. [00111 In another representative embodiment of the present disclosure, a 10 prosthetic device includes an anchoring member and an insert member having three expandable arms configured for deployment between the gaps in an insufficient aortic valve. Each arm desirably includes an expandable region that opens in a manner somewhat similar to a parachute for preventing regurgitation. During ventricular systole, each expandable region collapses 15 such that the flow of blood through the aortic valve is not impeded. 100121 In a certain representative embodiment of the present disclosure, a prosthetic device includes an insert member configured for deployment within an aortic 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 100131 In another representative embodiment of the present disclosure, a prosthetic device includes an anchoring member and an insert member 7532 I.)OC Pvl-5901 PCT WO 2007/140470 PCT/US2007/070141 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 mitral 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. [00141 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 100151 FIG. 1 illustrates a cross-sectional view of a heart. [00161 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. 100171 FIG. 3 is a cross-sectional view of an insert member with an outer coating of biocompatible material. [00181 FIG. 4 is a cross-sectional view of the insert member of FIG. 2 20 positioned in an aortic valve. [00191 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. 7532 1. DOC PVI-590 I PCT WO 2007/140470 PCT/US2007/070141 -7 [00201 FIG. 6 is a perspective view illustrating an embodiment of a prosthetic device wherein the insert member is directly attached to the anchoring member. [00211 FIG. 7 is a cross-sectional view of the insert member of FIG, 6 5 contained within a sheath in a contracted condition for delivery to a treatment site. [0022] FIG. 8 illustrates the insert member of FIG. 6 after being ejected from the sheath and expanding into an expanded condition. [00231 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. [00241 FIG. 9B is an exploded view of an exemplary embodiment of a plurality of engagement members shown in an expanded state. [00251 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. [00261 FIG. 10 is a variation of the embodiment shown in FIG. 9A wherein an alternative anchoring member is provided. 100271 FIG. 11 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. [0028] FIG. 12 is a perspective view of a prosthetic device similar to the embodiment illustrated in FIG. 2 in which the insert member is formed with two arms. 7532 1DOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 100291 FIG. 13 is a perspective view of a prosthetic device including an anchoring member and an insert member deployed in a heart for treating an insufficient mitral valve. 100301 FIG. 14 is a cross-sectional view of the insert member of FIG. 13. 5 100311 FIG. 15 is a cross-sectional view illustrating an insert member formed with a passageway and valve member for allowing blood to flow through the insert member in one direction. DETAILED DESCRIPTION OF SEVERAL EMBODIMENTS 10 [00321 1. Explanation of Terms 10033] Unless otherwise noted, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. In order to facilitate review of the various embodiments of the disclosure, the following explanation of terms 15 is provided: [00341 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 100351 The term "includes" means "comprises." For example, a device that includes or comprises A and B contains A and B, but may optionally contain C or other components other than A and B. Moreover, a device that 7532 1.DOC PI-5901 PCT WO 2007/140470 PCT/US2007/070141 includes or comprises A or B may contain A or B or A and B, and optionally one or more other components, such as C. 100361 The term "proximal" 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. 100371 The term "subject" refers to both human and other animal subjects. In certain embodiments, the subject is a human or other mammal, such as a primate, cat, dog, cow, horse, rodent, sheep, goat, or pig. In a particular example, the subject is a human patient. 10 100381 Although methods and materials similar or equivalent 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, the materials, methods, and examples are illustrative only and not intended to be limiting. 15 100391 I. An anatomical overview ofthe human heart [00401 With reference to FIG. 1, a cross-sectional view of a heart 1 is provided. Blood flows 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 7532 L DOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 10 right ventricle 15 for controlling 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. 100411 After exiting the lungs, the oxygenated blood flows through the 5 pulmonary veins 28 and enters the left atrium 26 of the heart 1. 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 connected 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 (also 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. 100421 HIL Prosthetic Device for reducing regurgitation through a heart valve 20 100431 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 flaccid, prolapsed leaflet. The leaflets may also have shrunk 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 normal flow of blood), commonly referred to as 75321 IDOC PV[5901 PCT WO 2007/140470 PCT/US2007/070141 -11 regurgitation, through the aortic valve into the left ventricle. Regurgitation may seriously impair the function of the heart since more blood will have to be pumped through the regurgitating valve to maintain adequate circulation. [00441 Embodiments of the present disclosure provide devices and 5 methods for improving the function of a defective heart valve, such as an aortic valve. The devices and methods disclosed herein are desirably delivered into a subject's heart using percutaneous or minimally invasive surgical methods. Accordingly, desirable delivery methods described herein do not require extracorporeal circulation (e.g., blood from a subject's circulation being routed 10 outside the body to have a process applied to and then, returned of the subject's circulation). For example, in one embodiment, a delivery catheter (or similar delivery device) is inserted 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 delivered 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 [00451 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 insert member 102 and an anchoring member 110. The insert member 102 desirably 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 non-perforated surface that does not include any openings through which blood can pass. As illustrated in FIG. 2, the insert member 102 includes a first extension portion, 7532 IDOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 - 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 members 120 for mounting the insert member 102 at a position spaced from the anchoring member 110. 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 100461 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 FIG. 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 [00471 In particular embodiments, the anchoring member 110 comprises a stent having a plurality of angularly-spaced axial struts, or support members, that extend axially (longitudinally) of the member. The anchoring member 110 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 7532 LDOC PV5901 PCT WO 2007/140470 PCT/US2007/070141 -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 110 may further include fixation or attachment members, such as barbs, staples, flanges, hooks, and the like along the exterior of the anchoring member 110 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, U.S. Patent No. 6,767,362, and U.S. Patent No. 6,908,481, each of which is incorporated herein by reference in its entirety. [00481 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 annulus. 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 circular 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. 7532 1I.DOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 - 14 100491 The insert member 102 is configured for insertion between the leaflets of an insufficient aortic valve so as to fill the gap between the leaflets. In one specific example, the insert member 102 exhibits sufficient 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 formed from plastic, metal (e.g., shape memory metal) or other bioc compatible 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 cloth-like 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 leaflets). For instance, smooth animal pericardium 15 such as equine, bovine, porcine or other animal pericardial tissue which is compatible with the native leaflets may be included within the outer layer 128. Such tissue may be tanned or fixed by a suitable tanning environment or the pericardium can be cross-linked with glutaraldehyde and heparin bonded by a detoxification process. In a certain example, the biological tissue material can 20 be one of the NO-REACT* natural tissue products exhibit improved biocompatibility and mitigate calcification 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 100501 In certain examples, the diameter of the insert member 102 is similar to the diameter of the native aortic valve such that each of the extension portions extends into a cusp between leaflets in the aortic valve. As a result, 7532 1.DOC PV[-5901 PCT WO 2007/140470 PCT/US2007/070141 - 15 the insert member 102 of the device 100 remains centered within the aortic valve after deployment. In certain examples, the diameter of the insert member is about 18 mm to about 26 mm, with about 22 mm being a specific example. The diameter of the insert member 102 can be slightly smaller as 5 compared to the diameter of the anchoring member 110. This configuration allows the insert member to collapse or fold-down to a reduced diameter for delivery in a delivery sheath. Additionally, the length 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. In other 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 insert member is about 20 mm to about 30 mm, with about 25 mm being a specific example. [00511 As illustrated in FIG. 4, the cross-sectional profile of the insert member 102 can be shaped such that the native leaflets 36a, 36b, 36c 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 eliminate hemolytic effects. Further, each 25 of the arms is configured to fill a gap between adjacent leaflets of an aortic valve, thereby preventing regurgitation through the aortic valve, The contact surfaces of the arms can exhibit sufficient compliancy and/or flexibility to 7532 1 .DOC PV-5901 PCT WO 2007/140470 PCT/US2007/070141 - 16 allow the native leaflets to engage the insert member 102 and create a tight seal without damaging the leaflets. For example, as described above, each arm can include biocompatible 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. [00521 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 left 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 10 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. [00531 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 leaflets. In one example, the movable flaps 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 systole, the moveable flaps collapse to allow blood to flow from the left ventricle, through the native aortic valve and into the aorta in a substantially unimpeded manner. Additional details regarding an expandable 25 insert member (e.g., valve portion) can be found in Applicant's co-pending U.S. Application No. 11/407,582 (U.S. Patent Publication No. 2006/0241745), filed on April 19, 2006, which is hereby incorporated by reference in its 7532 I.DOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 17 entirety. Principles and features of the expandable prosthetic 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. 10054] 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 member can be generally cylindrical in shape, although any other suitable shape may be employed. In 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 the insert 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 formed of plastic, metal or other biocompatible material 15 suitable for implantation into a subject. The connecting 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 ostia and the insert member 102 positioned in the native aortic valve. 100551 As best illustrated in FIG. 4, the native leaflets 36a, 36b, 36c of the 20 aortic valve 32 contact the insert member 102 during ventricular diastole to create a tight seal. By allowing the aortic valve 32 to create a tight seal, regurgitation from the aorta into the left ventricle is minimized or prevented. During ventricular systole, the native leaflets open as they do naturally to allow blood to be pumped from the left ventricle into the aorta. As can be seen in 25 FIG. 4, the cross-sectional area of the insert member 102 is relatively small as compared with the flow area through the aortic annulus. Accordingly, in the 7532 L.DOC PVl-5901 PCT WO 2007/140470 PCT/US2007/070141 -18 illustrated embodiment, the insert member 102 will not substantially impede the flow of blood through the aortic valve during ventricular systole. [00561 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 aortic 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 [00571 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. [00581 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 7532 LDOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 19 illustrated embodiment is directly coupled to the anchoring member 110 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 received 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 [00591 The disclosed prosthetic devices can be configured to be delivered in a percutaneous or minimally invasive procedure in which only a small 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, illustrates 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 profile of the insert during delivery. After being ejected from the sheath 142, the anchoring 20 member 110 and insert member 102 expand to a fully expanded condition as shown in FIG. 8. When delivered to the aortic valve in a percutaneous procedure, it may be desirable to utilize a deflectable sheath to facilitate navigation through the patient's 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 pending U.S. Application No. 11/152,288, filed June 13, 2005, entitled "Heart 7532 1.IOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 -20 Valve Delivery System," which is hereby incorporated by reference in its entirety. [00601 FIG. 9A illustrates a prosthetic device 300 that can be used to reduce or eliminate heart valve regurgitation, 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 impairing 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. 100611 The prosthetic device 300 can be positioned within the heart to 25 minimize aortic valve regurgitation by positioning the plurality of engagement members 304 in the left ventricle near the left ventricular apex. In the illustrated embodiment, a plurality of fingers or hooks penetrates tissue along 7532 1.DOC PVL-5901 PCT WO 2007/140470 PCT/US2007/070141 -21 the left ventricle muscular wall near the left ventricular apex. The insert member 102 is positioned in the aortic valve annulus such that an upper portion and lower portion extend above and below the native aortic valve and the arms of the insert member 102 are aligned with coaptions of the three cusps 5 of aortic valve so each leaflet moves up and down between the insert arms. [00621 FIGS. 9B and 9C illustrate the lower end portion of an anchor member 302 with a plurality of engagement members 304 in the form of elongated prongs. The elongated prongs 304 are desirably 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 desirably 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. After 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.S. Application No. 11/750,272 (hereinafter "the '272 application"), which is incorporated herein by reference. In one pref erred 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. 7532 1.DOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 -22 100641 The surface of the anchor member 302, including 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. 100651 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 formed of any biocompatible 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 left ventricle and another plate 15 404 is disposed on the shaft outside the left ventricle to secure the shaft in place. [0066] 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 further embedding the anchoring member in the heart. Without the added stress that the insert member of the device may impart on 25 the tissue, the healing and over-growth may proceed more rapidly with less adverse affects (e.g., unwanted scarring). Additional details regarding 7532 1 .DOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 -23 exemplary anchoring members, expandable insert members and two-stage 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-leaflet bioprosthetic valve. In particular examples, the anchoring member and valve member may take the form of the Cribier-Edwards valve manufactured by Edwards Lifesciences of Irvine, California. Additional details regarding exemplary embodiments of a 10 stented valve can be found in U.S. Patent No. 6,893,460, which is hereby incorporated by reference in its entirety. [00681 The valve member 130 in the stent ensures unidirectional flow through the stent. The stent is desirably configured for delivery into an ascending aorta. The stent is expanded, either by self-expansion or by balloon 15 expansion, such that the stent is anchored in the aorta. After 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 function. Accordingly, two separate valves (i.e., the stented valve and the native valve) work in tandem for inhibiting regurgitation through 20 the aortic annulus. By deploying the insert member in the native valve, the native valve is allowed to function as it should and blood is allowed to flow into 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 before or after the native valve to further 25 influence and improve the native valve function and also to improve hemodynamics and/or perfusion into the coronary arteries. 7532 1.DOC PV-5901 PCT WO 2007/140470 PCT/US2007/070141 -24 [00691 With reference to FIG. 12, a prosthetic device 600 according to yet another embodiment is provided. The prosthetic device 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 FIG. 12 for preventing or reducing regurgitation in a three leaflet valve. 10 [00701 For purposes of illustration, desirable embodiments of a prosthetic device have been described above for use in a valve normally having three leaflets, such as an aortic valve. However, it will be recognized by those of ordinary skill in the art that variations of the devices may also be used to treat another valve with three leaflets, such as a pulmonary valve, in an analogous 15 manner. When used to treat the pulmonary valve, 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. 100711 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 illustrated in FIG. 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 leaflets of an insufficient mitral valve. 25 [00721 In one specific example, the insert member 1.02 exhibits sufficient rigidity to substantially maintain its deployed shape and is resilient and/or 7532 1.DOC PVI5901 PCT WO 2007/140470 PCT/US2007/070141 -25 flexible enough to be compressed to a reduced diameter for delivery in a delivery sheath. The insert member can be formed from plastic, metal or other biocompatible material suitable for implantation into a subject. In particular examples, as described previously, the insert member can include an outer 5 layer or sheath substantially formed of a biocompatible material, such as a cloth-like 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 leaflets). For instance, smooth animal 10 pericardium such as equine, bovine, porcine or other animal pericardial tissue which is compatible with the native leaflets may be included within the outer layer. Such tissue may be tanned or fixed by a suitable tanning environment or the pericardium can be cross-linked with glutaraldehyde and heparin bonded by a detoxification 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 thrombus formation. The outer layer can cover the entire outer surface of the insert member 1.02 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. 100731 The cross-sectional profile of the insert member 702 is shaped such that the native leaflets are capable of contacting the sides 703a and 703b of the insert member 702 to create a tight seal. As illustrated in FIGS. 13-15, the insert member 702 preferably has a crescent-shape cross-sectional profile to 25 better conform to the curvature of the native leaflets. The surface of the insert member 702 can be of a compliancy that allows the native leaflets to engage the insert member 702 to create a tight seal without damaging the leaflets. For 7532 1.DOC PvI5901 PCT WO 2007/140470 PCT/US2007/070141 -26 example, as described above, the surface can comprise a biocompatible material, such as collagen 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 during ventricular systole to create a tight seal and prevent regurgitation of blood from the left ventricle into the left atrium. [00741 In the illustrated embodiment, the anchoring member 704 of the prosthetic device 700 includes a shaft or elongated body portion 706, the 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 (elasticity, rigidity, resilience and the like) 15 desired for each part of the device 700. For example, the penetration member 708 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 702 to the heart without substantially impairing the wall. 20 100751 in one example, the anchoring member 704 may be configured for deployment in the left ventricle. FIG. 14 is a cross-sectional view of the insert member 702 shown in FIG. 13. In this embodiment, the insert member 702 can have a substantially solid cross-section. In a variation, as shown in FIG. 15, the insert member 702 may include a passageway extending along a 25 longitudinal axis. The passageway can be adapted to allow blood to flow through the insert member in one direction. A valve member can be included within the insert to ensure that blood flows in only one direction. In a 7532 1 DOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 -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. [00761 IV. System and Methods for reducing regurgitation through a heart valve 100771 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 catheter 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 desirably 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 75321 .DOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 -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. 100781 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 aortic valve and the anchoring member engages the inner wall of the aorta. 25 100791 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 7532 1 DOC PVI-5901 PCT WO 2007/140470 PCT/US2007/070141 -29 surgical procedure. In these embodiments, a delivery catheter may not be necessary since the defective native valve can be directly accessed. [00801 Although the disclosure 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 facilitate comprehension of the disclosure and should not be construed to limit the scope thereof. 7532 1.DOC PVI-5901 PCT
1. A device for improving the function of a bicuspid heart valve, comprising: an insert member configured for insertion between leaflets of the bicuspid heart valve, the insert member adapted to maintain a substantially constant outer profile after deployment, the insert member having first and second leaflet-contacting surfaces for sealing a gap between the leaflets of the bicuspid heart valve and preventing regurgitation from the left ventricle to the left atrium; an anchoring member coupled to the insert member, the anchoring member comprising an elongated body portion; and a penetration member adapted for engaging tissue along a wall of the left ventricle, the penetration member coupled to a bottom end of the elongated body portion; wherein the insert member further comprises a passageway and a valve member disposed within the passageway for allowing blood to flow in only one direction, the passageway extending along a longitudinal axis.
2. The device of claim 1, wherein the insert member has a substantially solid cross-section.
3. The device of claim 1, wherein the insert member comprises an inner support and an outer layer defining the first and second leaflet-contacting surfaces, the outer layer comprising a biological material to inhibit abrasion of the bicuspid heart valve leaflets when the bicuspid heart valve leaflets contact the first and second leaflet-contact surfaces. 31
4. The device of claim 3, wherein the outer layer is formed of pericardial tissue.
5. The device of claim 1, wherein the penetration member further comprises two plates configured to be disposed on opposite sides of the heart wall. Dated this 18 th day of June 2013 Edwards Lifesciences Corporation Patent Attorneys for the Applicant PETER MAXWELL AND ASSOCIATES
AU2007266448A 2006-06-01 2007-05-31 Prosthetic insert for improving heart valve function Active AU2007266448B2 (en)
AU2013245451A AU2013245451A1 (en) 2006-06-01 2013-10-15 Prosthetic insert for improving heart valve function
AU2017200732A AU2017200732B2 (en) 2006-06-01 2017-02-03 Prosthetic insert for improving heart valve function
AU2017204546A AU2017204546B2 (en) 2006-06-01 2017-07-03 Prosthetic insert for improving heart valve function
AU2013245451A Division AU2013245451A1 (en) 2006-06-01 2013-10-15 Prosthetic insert for improving heart valve function
AU2007266448A1 AU2007266448A1 (en) 2007-12-06
AU2007266448B2 true AU2007266448B2 (en) 2013-07-18
AU2007266448A Active AU2007266448B2 (en) 2006-06-01 2007-05-31 Prosthetic insert for improving heart valve function
WO2007050256A2 (en) * 2005-10-26 2007-05-03 Cardio Solutions Heart valve implant