Patent Grant
10631871
The present invention relates generally to medical methods, devices, and systems. In particular, the present invention relates to methods, devices, and systems for the endovascular, percutaneous or minimally invasive surgical treatment of bodily tissues, such as tissue approximation or valve repair. More particularly, the present invention relates to repair of valves of the heart and venous valves.
Surgical repair of bodily tissues often involves tissue approximation and fastening of such tissues in the approximated arrangement. When repairing valves, tissue approximation includes coapting the leaflets of the valves in a therapeutic arrangement which may then be maintained by fastening or fixing the leaflets. Such coaptation can be used to treat regurgitation which most commonly occurs in the mitral valve.
Mitral valve regurgitation is characterized by retrograde flow from the left ventricle of a heart through an incompetent mitral valve into the left atrium. During a normal cycle of heart contraction (systole), the mitral valve acts as a check valve to prevent flow of oxygenated blood back into the left atrium. In this way, the oxygenated blood is pumped into the aorta through the aortic valve. Regurgitation of the valve can significantly decrease the pumping efficiency of the heart, placing the patient at risk of severe, progressive heart failure.
Mitral valve regurgitation can result from a number of different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the valve chordae which connect the leaflets to the papillary muscles, the papillary muscles or the left ventricular wall may be damaged or otherwise dysfunctional. Commonly, the valve annulus may be damaged, dilated, or weakened, limiting the ability of the mitral valve to close adequately against the high pressures of the left ventricle.
The most common treatments for mitral valve regurgitation rely on valve replacement or repair including leaflet and annulus remodeling, the latter generally referred to as valve annuloplasty. A recent technique for mitral valve repair which relies on suturing adjacent segments of the opposed valve leaflets together is referred to as the “bow-tie” or “edge-to-edge” technique. While all these techniques can be very effective, they usually rely on open heart surgery where the patient's chest is opened, typically via a sternotomy, and the patient placed on cardiopulmonary bypass. The need to both open the chest and place the patient on bypass is traumatic and has associated high mortality and morbidity.
For these reasons, it would be desirable to provide alternative and additional methods, devices, and systems for performing the repair of mitral and other cardiac valves. Such methods, devices, and systems should preferably not require open chest access and be capable of being performed either endovascularly, i.e., using devices which are advanced to the heart from a point in the patient's vasculature remote from the heart or by a minimally invasive approach. Further, such devices and systems should provide features which allow repositioning and optional removal of a fixation device prior to fixation to ensure optimal placement. Still more preferably, the methods, devices, and systems would be useful for repair of tissues in the body other than heart valves. At least some of these objectives will be met by the inventions described hereinbelow.
Minimally invasive and percutaneous techniques for coapting and modifying mitral valve leaflets to treat mitral valve regurgitation are described in PCT Publication Nos. WO 98/35638; WO 99/00059; WO 99/01377; and WO 00/03759.
Maisano et al. (1998) Eur. J. Cardiothorac. Surg. 13:240-246; Fucci et al. (1995) Eur. J. Cardiothorac. Surg. 9:621-627; and Umana et al. (1998) Ann. Thorac. Surg. 66:1640-1646, describe open surgical procedures for performing “edge-to-edge” or “bow-tie” mitral valve repair where edges of the opposed valve leaflets are sutured together to lessen regurgitation. Dec and Fuster (1994) N. Engl. J. Med. 331:1564-1575 and Alvarez et al. (1996) J. Thorac. Cardiovasc. Surg. 112:238-247 are review articles discussing the nature of and treatments for dilated cardiomyopathy.
Mitral valve annuloplasty is described in the following publications. Bach and Bolling (1996) Am. J. Cardiol. 78:966-969; Kameda et al. (1996) Ann. Thorac. Surg. 61:1829-1832; Bach and Bolling (1995) Am. Heart J. 129:1165-1170; and Bolling et al. (1995) 109:676-683. Linear segmental annuloplasty for mitral valve repair is described in Ricchi et al. (1997) Ann. Thorac. Surg. 63:1805-1806. Tricuspid valve annuloplasty is described in McCarthy and Cosgrove (1997) Ann. Thorac. Surg. 64:267-268; Tager et al. (1998) Am. J. Cardiol. 81:1013-1016; and Abe et al. (1989) Ann. Thorac. Surg. 48:670-676.
Percutaneous transluminal cardiac repair procedures are described in Park et al. (1978) Circulation 58:600-608; Uchida et al. (1991) Am. Heart J. 121: 1221-1224; and Ali Khan et al. (1991) Cathet. Cardiovasc. Diagn. 23:257-262.
Endovascular cardiac valve replacement is described in U.S. Pat. Nos. 5,840,081; 5,411,552; 5,554,185; 5,332,402; 4,994,077; and 4,056,854. See also U.S. Pat. No. 3,671,979 which describes a catheter for temporary placement of an artificial heart valve.
Other percutaneous and endovascular cardiac repair procedures are described in U.S. Pat. Nos. 4,917,089; 4,484,579; and 3,874,338; and PCT Publication No. WO 91/01689.
Thoracoscopic and other minimally invasive heart valve repair and replacement procedures are described in U.S. Pat. Nos. 5,855,614; 5,829,447; 5,823,956; 5,797,960; 5,769,812; and 5,718,725.
The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.
In preferred embodiments, the devices, systems and methods of the invention are adapted for fixation of tissue at a treatment site. Exemplary tissue fixation applications include cardiac valve repair, septal defect repair, vascular ligation and clamping, laceration repair and wound closure, but the invention may find use in a wide variety of tissue approximation and repair procedures. In a particularly preferred embodiment, the devices, systems and methods of the invention are adapted for repair of cardiac valves, and particularly the mitral valve, as a therapy for regurgitation. The invention enables two or more valve leaflets to be coapted using an “edge-to-edge” or “bow-tie” technique to reduce regurgitation, yet does not require open surgery through the chest and heart wall as in conventional approaches. Using the devices, systems and methods of the invention, the mitral valve can be accessed from a remote surgical or vascular access point and the two valve leaflets may be coapted using endovascular or minimally invasive approaches. While less preferred, in some circumstances the invention may also find application in open surgical approaches as well. According to the invention, the mitral valve may be approached either from the atrial side (antegrade approach) or the ventricular side (retrograde approach), and either through blood vessels or through the heart wall.
The devices, systems and methods of the invention are centered on variety of devices which may be used individually or in a variety of combinations to form interventional systems. In preferred embodiments, the interventional system includes a multi-catheter guiding system, a delivery catheter and an interventional device. Each of these components will be discussed herein.
In an exemplary embodiment, the invention provides a fixation device having a pair of distal elements (or fixation elements), each distal element having a free end and an engagement surface for engaging the tissue, wherein the distal elements are moveable between a first position for capturing the tissue and a second position for fixing the tissue. Preferably, the engagement surfaces are spaced apart in the first position and are closer together and generally face toward each other in the second position. The fixation device is preferably delivered to a target location in a patient's body by a delivery catheter having an elongated shaft, a proximal end and a distal end, the delivery catheter being configured to be positioned at the target location from a remote access point such as a vascular puncture or cut-down or a surgical penetration. In a preferred embodiment, the target location is a valve in the heart.
The fixation device is preferably delivered with the distal elements in a delivery position configured to minimize the profile of the device. When approaching the mitral valve from the atrial side, some embodiments of the fixation device allow the device to be delivered with the free ends of the distal elements pointing in a generally proximal direction forming an angle of less than about 90°, preferably less than about 20°, relative to the longitudinal axis of the delivery device shaft. In this position the engagement surfaces are facing generally toward each other, being disposed at an angle of less than about 180°, and preferably less than about 40°, relative to each other. For ventricular approaches, in the delivery position the free ends of the distal elements are pointing in a generally distal direction and form an angle of less than about 90°, preferably less than about 20° relative to the longitudinal axis of the delivery device shaft. In this position, the engagement surfaces are facing generally toward each other, usually being disposed at an angle of less than about 180°, and preferably less than about 90°, relative to each other. Alternatively, in some ventricular approaches, it may be preferred to have the free ends of the fixation elements pointing in a generally proximal direction and the engagement surfaces facing away from each other in the delivery position.
In order to provide for the reversibility and removability of the devices and systems of the invention, the distal elements preferably are movable to an inverted position that minimizes entanglement and interferences with surrounding tissues should the device be desired to be withdrawn. In mitral repair applications, this is particularly important due to the presence of chordae tendonae, valve leaflets and other tissues with which devices may become entangled. For approaches from the atrial side of the mitral valve, in the inverted position, the free ends will be pointing in a generally distal direction relative to the catheter shaft and the engagement surfaces will be facing generally away from each other, usually being disposed at an angle of more than about 180°, and preferably more than 270°, relative to each other. For ventricular approaches to the valve, in the inverted position the free ends will be pointing in a distal direction relative to the catheter shaft and the engagement surfaces will be facing generally toward each other, usually being disposed at an angle of less than about 180°, and preferably less than 90°, relative to each other.
In the open position, the engagement surfaces of the distal elements preferably form an angle of up to 180° relative to each other so as to maximize the area in which to capture the valve leaflets or other target tissue. The distal elements are preferably movable to a closed position in which the engagement surfaces engage each other or form an angle as small as 0° relative to each other. The distal elements are configured to be adjusted to and left permanently in any of various positions between the open and closed positions to allow for fixation of tissues of various thickness, geometry, and spacing.
In a preferred embodiment, the fixation device of the invention will further include at least one proximal element (or gripping element). Each proximal element and distal element will be movable relative to each other and configured to capture tissue between the proximal element and the engagement surface of the distal element. Preferably, the distal elements and proximal elements are independently movable but in some embodiments may be movable with the same mechanism. The proximal element may be preferably biased toward the engagement surface of the fixation element to provide a compressive force against tissue captured therebetween.
In another aspect, the invention provides a fixation device for engaging tissue comprising a coupling member configured for coupling a catheter and a pair of distal elements connected to the coupling member, each distal element having an engagement surface for engaging the tissue. The distal elements are moveable between an open position wherein the distal elements extend radially outwardly facing the engagement surfaces toward a first direction, and an inverted position wherein the distal elements have rotated away from the first direction facing the engagement surfaces radially outwardly.
In a further aspect, the distal elements of the invention are adapted to receive a suture passed through the target tissue. For example, implant pledgets may be detachably mounted to the distal elements so as to be positionable against a surface of tissue engaged by the distal elements. A suture may then be passed through the tissue and implant pledget, which are supported by the distal element. The implant pledgets are then detached from the distal elements, which may be withdrawn from the site, and the suture is tensioned and secured to the target tissue. The delivery catheter, in this embodiment, will further include a movable fixation tool or penetration element for penetrating the target tissue and the implant pledget. A suture is coupled to the penetration element and preferably an anchor is attached to the suture. The penetration element is movable relative to the catheter to penetrate the target tissue and the implant pledget, bringing with it the suture and anchor. The anchor is configured to deploy into an expanded configuration so as to securely engage the implant pledget opposite the target tissue, retaining the suture therein. For the mitral valve, an implant pledget and suture may be similarly deployed in both leaflets, and the sutures secured to one another to coapt the leaflets. Thus, in this embodiment, the distal elements are used to deliver implant pledgets and secure them to the target tissue, but are not themselves deployed at the site as in other embodiments. However, following deployment of the implant pledgets and associated sutures, the distal elements must be withdrawn from the body. For this purpose, the distal elements are movable to an inverted position like the embodiments described above to facilitate withdrawing the device without interference or injury to surrounding tissues.
In some applications such as the repair of the mitral valve, the fixation device is adapted to be detached from the delivery catheter and left permanently in the patient. In such applications, it is often desirable to promote tissue growth around the fixation device. For this purpose, some or all of the components of the fixation device are preferably covered with a covering or coating to promote tissue growth. In one embodiment, a biocompatible fabric cover is positioned over the distal elements and/or the proximal elements. The cover may optionally be impregnated or coated with various therapeutic agents, including tissue growth promoters, antibiotics, anti-clotting, blood thinning, and other agents. Alternatively or in addition, some or all of the fixation element and/or covering may be comprised of a bioerodable, biodegradable or bioabsorbable material so that it may degrade or be absorbed by the body after the repaired tissues have grown together.
The distal elements and proximal elements will be configured to provide high retention force so that the fixation device remains securely fastened to the target tissue throughout the cardiac cycle. At the same time, the distal and proximal elements will be configured to minimize trauma to the tissue engaged by them. This allows the fixation device to be removed from the tissue after initial application without creating clinically significant injury to the tissue. In order to enhance retention without creating significant trauma, the proximal elements and/or the distal elements may have friction-enhancing features on their surfaces that engage the target tissue. Such friction-enhancing features may include barbs, bumps, grooves, openings, channels, surface roughening, coverings, and coatings, among others. Optionally, magnets may be present in the proximal and/or distal elements. Preferably the friction-enhancing features and the magnets will be configured to increase the retention force of the distal and proximal elements on the tissue, while not leaving significant injury or scarring if the device is removed.
The distal and proximal elements may further have a shape and flexibility to maximize retention force and minimize trauma to the target tissue. In a preferred embodiment, the engagement surfaces of the distal elements have a concave shape configured to allow the proximal elements, along with the target tissue, to be nested or recessed within the distal elements. This increases the surface area of the tissue engaged by the distal elements and creates a geometry of tissue engagement that has a higher retention force than a planar engagement surface. To minimize trauma, the longitudinal edges as well as the free ends of the distal elements are preferably curved outwardly away from the engagement surface so that these edges present a rounded surface against the target tissue. The distal elements and/or the proximal elements may also be flexible so that they deflect to some degree in response to forces against the tissue engaged thereby, reducing the chances that the tissue will tear or bruise in response to such forces.
The fixation device will include an actuation mechanism for moving the distal elements between the open, closed, and inverted positions. A variety of actuation mechanisms may be used. In an exemplary embodiment, a coupling member connects the fixation device to the delivery catheter, and a stud is slidably coupled to the coupling member. In a “push to close/pull to open” embodiment, the distal elements are pivotably coupled to the stud and the actuation mechanism comprises a pair of link members connected between the distal elements and the coupling member, whereby sliding the stud relative to the coupling member pivots the distal elements inwardly or outwardly into the various positions. Alternatively, in a “push to open/pull to close” embodiment, the distal elements are pivotably coupled to the coupling member and the links connected between the distal elements and the stud.
The fixation device of the invention preferably includes a coupling member that is detachably connectable to the delivery catheter. The coupling member may have various constructions, but in an exemplary embodiment comprises an outer member having an axial channel, the outer member being coupled to one of either the distal elements or the actuation mechanism. An inner member extends slidably through the axial channel and is coupled to the other of either the distal elements or the actuation mechanism. The delivery catheter will be configured to detachably connect to both the inner member and the outer member. In one embodiment, the delivery catheter has a tubular shaft and an actuator rod slidably disposed in the tubular shaft. The junction of the outer member with the tubular shaft comprises a joining line, which may have a variety of shapes including sigmoid curves. The actuator rod extends from the delivery catheter through the axial channel in the outer member to maintain its connection with the tubular shaft. The actuator rod may be connected to the inner member by various connection structures, including threaded connections. By detachment of the actuator rod from the inner member and retraction of the actuator rod back into the tubular shaft, the outer member is released from the tubular shaft to allow deployment of the fixation device.
In a preferred embodiment, the fixation device further includes a locking mechanism that maintains the distal elements in a selected position relative to each other. Because the ideal degree of closure of the fixation device may not be known until it is actually applied to the target tissue, the locking mechanism is configured to retain the distal elements in position regardless of how open or closed they may be. While a variety of locking mechanisms may be used, in an exemplary embodiment the locking mechanism comprises a wedging element that is movable into frictional engagement with a movable component of the fixation device to prevent further movement of the distal elements. In embodiments utilizing the actuation mechanism described above, the component with which the wedging element engages may be the coupling member or the stud slidably coupled thereto. In one embodiment, the stud passes through an aperture in the coupling member that has a sloping sidewall, and the wedging element comprises a barbell disposed between the sidewall and the stud.
The fixation device preferably also includes an unlocking mechanism for releasing the locking mechanism, allowing the distal elements and proximal elements to move. In one embodiment, the unlocking mechanism comprises a harness coupled to the wedging element of the locking mechanism to reduce frictional engagement with the movable component of the fixation device. In an exemplary embodiment, the harness is slidably coupled to the coupling member and extends around the wedging element of the locking mechanism, whereby the harness can be retracted relative to the coupling member to disengage the wedging element from the stud.
In a further aspect, the invention provides an interventional system comprising a tubular guide having a proximal end, a distal end and a channel therebetween, the distal end of the tubular guide being deflectable about a first axis; a delivery catheter positionable through the channel, the delivery catheter having a flexible shaft with a proximal end, a distal end, a lumen therebetween, and an actuation element movably disposed in the lumen; and a fixation device having a coupling member releasably coupled to the distal end of the shaft, a first distal element movably coupled to the coupling member, and a first proximal element movable relative to the distal element, the first distal element being releasably coupled to the actuation element and movable therewith, the first distal element and the first proximal element being adapted to engage tissue therebetween.
The delivery device of the invention is adapted to allow the user to deliver the fixation device to the target site from a remote access point, whether through endovascular or surgical approaches, align the device with the target tissue, and to selectively close, open, invert, lock or unlock the distal element. In some embodiments, the delivery device will have a highly flexible, kink resistant, torsionally stiff shaft with minimal elongation and high compressive strength. The delivery device will also have the movable components and associated actuators to move the distal elements between the open, closed, and inverted positions, to move the proximal elements into engagement with the target tissue, to unlock the locking mechanism, and to detach the distal element from the delivery catheter. In a preferred embodiment, the delivery device comprises a delivery catheter having an elongated shaft which has an inner lumen. The distal end of the shaft is configured for detachable connection to the coupling member of the fixation device. An actuator rod is slidably disposed in the inner lumen and is adapted for detachable coupling to the stud or other component of the fixation device that moves the distal elements. A plurality of tubular guides, preferably in the form of metallic or polymeric coils, extend through the inner lumen of the shaft and are typically fixed to the shaft near its proximal and distal ends but are unrestrained therebetween, providing a highly flexible and kink-resistant construction. Lines for actuating the proximal elements and the unlocking mechanism of the fixation device extend through these tubular guides and are detachably coupled to the proximal element and unlocking mechanisms. These and other aspects of delivery catheters suitable for use in the present invention are described in copending application Ser. No. 10/441,687, filed on the same day as the present application, which has been incorporated herein by reference.
The delivery catheter may additionally include a tether that is detachably coupled to a portion of the fixation device for purposes of retrieval of the device following detachment from the delivery catheter. The tether may be a separate flexible filament extending from the delivery catheter to the fixation device, but alternatively may be a line coupled to either the unlocking mechanism or the proximal element and used also for actuating those components. In either case, the tether will be detachable from the fixation device so that it may be detached once the device has been deployed successfully.
The system of the invention may additionally include a guide that facilitates introduction and navigation of the delivery catheter and fixation device to the target location. The guide is preferably tubular with a channel extending between its proximal and distal ends in which the delivery catheter and fixation device may be slidably positioned. The distal end of the guide is steerable, usually being deflectable about at least one axis, and preferably about two axes. The guide will have a size, material, flexibility and other characteristics suitable for the application in which it is being used. For mitral valve repair, the guide is preferably configured to be introduced in a femoral vein and advanced through the inferior vena cava into the heart, across a penetration in the interatrial septum, and into alignment with the mitral valve in the left atrium. Alternatively, the guide may be configured for introduction in a femoral, axillary, or brachiocephalic artery and advancement through the aorta and aortic valve into the ventricle where it is steered into alignment with the mitral valve. In a further alternative, the guide may be configured for introduction through a puncture or incision in the chest wall and through an incision in the wall of the heart to approach the mitral valve.
In an exemplary embodiment, the guide comprises a multi-catheter guiding system which has two components, including an inner tubular member or inner guide catheter and an outer tubular member or outer guide catheter. The inner tubular member has a distal end deflectable about a first axis. The outer tubular member has a distal end deflectable about a second axis. Further, the inner tubular member may be rotatable relative to the outer tubular member about its longitudinal axis. Mobility in additional directions and about additional axes may optionally be provided. Additional aspects of guides usable in the system of the invention are described in pending application Ser. No. 10/441,508, which has been incorporated herein by reference.
The invention further provides methods of performing therapeutic interventions at a tissue site. In one embodiment, the method includes the steps of advancing an interventional tool having a proximal end, a distal end and a fixation device near the distal end to a location within a patient's body, wherein the fixation device includes a pair of distal elements each having a free end and an engagement surface; moving the distal elements to an open position wherein the free ends are spaced apart; positioning the distal elements such that the engagement surfaces engage tissue at the tissue site; and detaching the fixation device from the interventional tool. Preferably, the method further includes the step of inverting the distal elements to an inverted position wherein the free ends point generally in a distal direction. In some embodiments, the engagement surfaces will face generally away from each other in the inverted position, while in other embodiments, the engagement surfaces will face generally toward each other in the inverted position.
In an exemplary embodiment, the tissue site comprises first and second leaflets, and the step of moving the distal elements comprises coapting the leaflets. The leaflets may be part of a variety of tissue structures, but are preferably part of a cardiac valve such as the mitral valve. In antegrade approaches, the step of advancing will usually include inserting the fixation device through a valve annulus, e.g. from an atrium of the heart to a ventricle of the heart. In such approaches, the method may further include a step of withdrawing the fixation device through the valve annulus with the fixation device in the inverted position. Retrograde approaches are also provided, in which the step of advancing will include the step of passing the fixation device through a ventricle of the heart into an atrium of the heart. The step of advancing may further comprise transluminally positioning the fixation device through a blood vessel into the heart, and may include inserting the fixation device through an interatrial septum of the heart. Alternatively, the step of advancing may comprise inserting the device through a surgical penetration in a body wall.
The method may further include moving the distal elements to a closed position after the step of positioning, the free ends of the distal element being closer together in the closed position with the engagement surfaces facing generally toward each other. In addition, the method may include a step of deploying a proximal element on the fixation device toward each engagement surface to as to capture tissue therebetween. Before the step of inverting, the proximal elements are retracted away from the engagement surfaces. The method optionally includes a step of locking the distal elements in a desired position, and may further include a step of unlocking the distal elements so that they are movable again.
In a further aspect, a method according to the invention comprises advancing a catheter having a proximal end, a distal end and a fixation device near the distal end to a location within a body, wherein the fixation device includes a pair of distal elements each having an engagement surface; moving the distal elements to an open position wherein the distal elements extend radially outwardly facing the engagement surfaces toward a direction other than radially outwardly; and moving the distal elements to an inverted position wherein the engagement surfaces face radially outwardly.
In still another aspect, the invention provides a method for fixing tissues together comprising advancing a catheter having a proximal end, a distal end and a fixation device disposed near the distal end to a location near the tissues, wherein the fixation device includes a pair of distal elements each having a removable implant pledget; moving the distal elements so that each implant pledget engages one of the tissues; penetrating each tissue and engaged implant pledget and passing a tie therethrough; fastening the ties to fix the tissues together; and removing the fixation device leaving the implant pledget in place.
In an additional aspect of the invention, kits for performing an intervention at a tissue site in a patient's body include a fixation device and Instructions for Use setting forth the steps of using the fixation device according to the methods of the invention. The fixation device may be as described in any of the various examples set forth herein. The kits may further include a delivery tool or catheter for delivering the fixation device to the tissue site, as well as a tubular guide through which the delivery tool or catheter may be positioned.
Other aspects of the nature and advantages of the invention are set forth in the detailed description set forth below, taken in conjunction with the drawings.
I. Cardiac Physiology
The left ventricle LV of a normal heart H in systole is illustrated in
A number of structural defects in the heart can cause mitral valve regurgitation. Regurgitation occurs when the valve leaflets do not close properly allowing leakage from the ventricle into the atrium. As shown in
II. General Overview
The present invention provides methods and devices for grasping, approximating and fixating tissues such as valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. The present invention also provides features that allow repositioning and removal of the device if so desired, particularly in areas where removal may be hindered by anatomical features such as chordae CT. Such removal would allow the surgeon to reapproach the valve in a new manner if so desired.
Grasping will preferably be atraumatic providing a number of benefits. By atraumatic, it is meant that the devices and methods of the invention may be applied to the valve leaflets and then removed without causing any significant clinical impairment of leaflet structure or function. The leaflets and valve continue to function substantially the same as before the invention was applied. Thus, some minor penetration or denting of the leaflets may occur using the invention while still meeting the definition of “atraumatic”. This enables the devices of the invention to be applied to a diseased valve and, if desired, removed or repositioned without having negatively affected valve function. In addition, it will be understood that in some cases it may be necessary or desirable to pierce or otherwise permanently affect the leaflets during either grasping, fixing or both. In some of these cases, grasping and fixation may be accomplished by a single device. Although a number of embodiments are provided to achieve these results, a general overview of the basic features will be presented herein. Such features are not intended to limit the scope of the invention and are presented with the aim of providing a basis for descriptions of individual embodiments presented later in the application.
The devices and methods of the invention rely upon the use of an interventional tool that is positioned near a desired treatment site and used to grasp the target tissue. In endovascular applications, the interventional tool is typically an interventional catheter. In surgical applications, the interventional tool is typically an interventional instrument. In preferred embodiments, fixation of the grasped tissue is accomplished by maintaining grasping with a portion of the interventional tool which is left behind as an implant. While the invention may have a variety of applications for tissue approximation and fixation throughout the body, it is particularly well adapted for the repair of valves, especially cardiac valves such as the mitral valve. Referring to
The fixation device 14 is releasably attached to the shaft 12 of the interventional tool 10 at its distal end. When describing the devices of the invention herein, “proximal” shall mean the direction toward the end of the device to be manipulated by the user outside the patient's body, and “distal” shall mean the direction toward the working end of the device that is positioned at the treatment site and away from the user. With respect to the mitral valve, proximal shall refer to the atrial or upstream side of the valve leaflets and distal shall refer to the ventricular or downstream side of the valve leaflets.
The fixation device 14 typically comprises proximal elements 16 (or gripping elements) and distal elements 18 (or fixation elements) which protrude radially outward and are positionable on opposite sides of the leaflets LF as shown so as to capture or retain the leaflets therebetween. The proximal elements 16 are preferably comprised of cobalt chromium, nitinol or stainless steel, and the distal elements 18 are preferably comprised of cobalt chromium or stainless steel, however any suitable materials may be used. The fixation device 14 is coupleable to the shaft 12 by a coupling mechanism 17. The coupling mechanism 17 allows the fixation device 14 to detach and be left behind as an implant to hold the leaflets together in the coapted position.
In some situations, it may be desired to reposition or remove the fixation device 14 after the proximal elements 16, distal elements 18, or both have been deployed to capture the leaflets LF. Such repositioning or removal may be desired for a variety of reasons, such as to reapproach the valve in an attempt to achieve better valve function, more optimal positioning of the device 14 on the leaflets, better purchase on the leaflets, to detangle the device 14 from surrounding tissue such as chordae, to exchange the device 14 with one having a different design, or to abort the fixation procedure, to name a few. To facilitate repositioning or removal of the fixation device 14 the distal elements 18 are releasable and optionally invertible to a configuration suitable for withdrawal of the device 14 from the valve without tangling or interfering with or damaging the chordae, leaflets or other tissue.
Once the leaflets are coapted in the desired arrangement, the fixation device 14 is then detached from the shaft 12 and left behind as an implant to hold the leaflets together in the coapted position. As mentioned previously, the fixation device 14 is coupled to the shaft 12 by a coupling mechanism 17.
Similarly,
In a preferred embodiment, mating surface 24 (or mating surface 32) is a sigmoid curve defining a male element and female element on upper shaft 20 (or upper shaft 28) which interlock respectively with corresponding female and male elements on lower shaft 22 (or lower shaft 30). Typically, the lower shaft is the coupling mechanism 17 of the fixation device 14. Therefore, the shape of the mating surface selected will preferably provide at least some mating surfaces transverse to the axial axis of the a mechanism 19 to facilitate application of compressive and tensile forces through the coupling mechanism 17 to the fixation device 14, yet causing minimal interference when the fixation device 14 is to be released from the upper shaft.
III. Fixation Device
A. Introduction and Placement of Fixation Device
The fixation device 14 is delivered to the valve or the desired tissues with the use of a delivery device. The delivery device may be rigid or flexible depending on the application. For endovascular applications, the delivery device comprises a flexible delivery catheter which will be described in later sections. Typically, however, such a catheter comprises a shaft, having a proximal end and a distal end, and a fixation device releasably attached to its distal end. The shaft is usually elongate and flexible, suitable for intravascular introduction. Alternatively, the delivery device may comprise a shorter and less flexible interventional instrument which may be used for trans-thoracic surgical introduction through the wall of the heart, although some flexibility and a minimal profile will generally be desirable. A fixation device is releasably coupleable with the delivery device as illustrated in
In this embodiment, proximal elements 16 comprise resilient loop-shaped wire forms biased outwardly and attached to the coupling member 19 so as to be biased to an open position shown in
In some situations, as previously mentioned, it may be desirable to reopen the fixation device 14 following initial placement. To reopen the device 14, the actuator rod may be readvanced or reinserted through the coupling member 19 and readvanced to press against the actuation mechanism 58, as previously indicated by arrow 62 in
Under some circumstances, it may be further desirable to withdraw the fixation device 14 back through the valve or completely from the patient following initial insertion through the valve. Should this be attempted with the clip in the closed or open positions illustrated in
With arms 53 in the inverted position, engagement surfaces 50 provide an atraumatic surface deflect tissues as the fixation device is withdrawn. This allows the device to be retracted back through the valve annulus without risk of injury to valvular and other tissues. In some cases, once the fixation device 14 has been pulled back through the valve, it will be desirable to return the device to the closed position for withdrawal of the device from the body (either through the vasculature or through a surgical opening).
The embodiment illustrated in
In a further embodiment, some or all of the components may be molded as one part, as illustrated in
In a preferred embodiment suitable for mitral valve repair, the transverse width across engagement surfaces 50 (which determines the width of tissue engaged) is at least about 2 mm, usually 3-10 mm, and preferably about 4-6 mm. In some situations, a wider engagement is desired wherein the engagement surfaces 50 are larger, for example about 2 cm, or multiple fixation devices are used adjacent to each other. Arms 53 and engagement surfaces 50 are configured to engage a length of tissue of about 4-10 mm, and preferably about 6-8 mm along the longitudinal axis of arms 53. Arms 53 further include a plurality of openings to enhance grip and to promote tissue ingrowth following implantation.
The valve leaflets are grasped between the distal elements 18 and proximal elements 16. In some embodiments, the proximal elements 16 are flexible, resilient, and cantilevered from coupling member 19. The proximal elements are preferably resiliently biased toward the distal elements. Each proximal element 16 is shaped and positioned to be at least partially recessed within the concavity of the distal element 18 when no tissue is present. When the fixation device 14 is in the open position, the proximal elements 16 are shaped such that each proximal element 16 is separated from the engagement surface 50 near the proximal end 52 of arm 53 and slopes toward the engagement surface 50 near the free end 54 with the free end of the proximal element contacting engagement surface 50, as illustrated in
Proximal elements 16 include a plurality of openings 63 and scalloped side edges 61 to increase grip on tissue. The proximal elements 16 optionally include frictional accessories, frictional features or grip-enhancing elements to assist in grasping and/or holding the leaflets. In preferred embodiments, the frictional accessories comprise barbs 60 having tapering pointed tips extending toward engagement surfaces 50. It may be appreciated that any suitable frictional accessories may be used, such as prongs, windings, bands, barbs, grooves, channels, bumps, surface roughening, sintering, high-friction pads, coverings, coatings or a combination of these. Optionally, magnets may be present in the proximal and/or distal elements. It may be appreciated that the mating surfaces will be made from or will include material of opposite magnetic charge to cause attraction by magnetic force. For example, the proximal elements and distal elements may each include magnetic material of opposite charge so that tissue is held under constant compression between the proximal and distal elements to facilitate faster healing and ingrowth of tissue. Also, the magnetic force may be used to draw the proximal elements 16 toward the distal elements 18, in addition to or alternatively to biasing of the proximal elements toward the distal elements. This may assist in deployment of the proximal elements 16. In another example, the distal elements 18 each include magnetic material of opposite charge so that tissue positioned between the distal elements 18 is held therebetween by magnetic force.
The proximal elements 16 may be covered with a fabric or other flexible material as described below to enhance grip and tissue ingrowth following implantation. Preferably, when fabrics or coverings are used in combination with barbs or other frictional features, such features will protrude through such fabric or other covering so as to contact any tissue engaged by proximal elements 16.
In an exemplary embodiment, proximal elements 16 are formed from metallic sheet of a spring-like material using a stamping operation which creates openings 63, scalloped edges 61 and barbs 60. Alternatively, proximal elements 16 could be comprised of a spring-like material or molded from a biocompatible polymer. It should be noted that while some types of frictional accessories that can be used in the present invention may permanently alter or cause some trauma to the tissue engaged thereby, in a preferred embodiment, the frictional accessories will be atraumatic and will not injure or otherwise affect the tissue in a clinically significant way. For example, in the case of barbs 60, it has been demonstrated that following engagement of mitral valve leaflets by fixation device 14, should the device later be removed during the procedure barbs 60 leave no significant permanent scarring or other impairment of the leaflet tissue and are thus considered atraumatic.
The fixation device 14 also includes an actuation mechanism 58. In this embodiment, the actuation mechanism 58 comprises two link members or legs 68, each leg 68 having a first end 70 which is rotatably joined with one of the distal elements 18 at a riveted joint 76 and a second end 72 which is rotatably joined with a stud 74. The legs 68 are preferably comprised of a rigid or semi-rigid metal or polymer such as Elgiloy®, cobalt chromium or stainless steel, however any suitable material may be used. While in the embodiment illustrated both legs 68 are pinned to stud 74 by a single rivet 78, it may be appreciated, however, that each leg 68 may be individually attached to the stud 74 by a separate rivet or pin. The stud 74 is joinable with an actuator rod 64 (not shown) which extends through the shaft 12 and is axially extendable and retractable to move the stud 74 and therefore the legs 68 which rotate the distal elements 18 between closed, open and inverted positions. Likewise, immobilization of the stud 74 holds the legs 68 in place and therefore holds the distal elements 18 in a desired position. The stud 74 may also be locked in place by a locking feature which will be further described in later sections.
In any of the embodiments of fixation device 14 disclosed herein, it may be desirable to provide some mobility or flexibility in distal elements 18 and/or proximal elements 16 in the closed position to enable these elements to move or flex with the opening or closing of the valve leaflets. This provides shock absorption and thereby reduces force on the leaflets and minimizes the possibility for tearing or other trauma to the leaflets. Such mobility or flexibility may be provided by using a flexible, resilient metal or polymer of appropriate thickness to construct the distal elements 18. Also, the locking mechanism of the fixation device (described below) may be constructed of flexible materials to allow some slight movement of the proximal and distal elements even when locked. Further, the distal elements 18 can be connected to the coupling mechanism 19 or to actuation mechanism 58 by a mechanism that biases the distal element into the closed position (inwardly) but permits the arms to open slightly in response to forces exerted by the leaflets. For example, rather than being pinned at a single point, these components may be pinned through a slot that allowed a small amount of translation of the pin in response to forces against the arms. A spring is used to bias the pinned component toward one end of the slot.
Proximal elements 16 are typically biased outwardly toward arms 53. The proximal elements 16 may be moved inwardly toward the shaft 12 and held against the shaft 12 with the aid of proximal element lines 90 which can be in the form of sutures, wires, nitinol wire, rods, cables, polymeric lines, or other suitable structures. The proximal element lines 90 may be connected with the proximal elements 16 by threading the lines 90 in a variety of ways. When the proximal elements 16 have a loop shape, as shown in
In the open position, the fixation device 14 can engage the tissue which is to be approximated or treated. The embodiment illustrated in
The interventional tool 10 may be repeatedly manipulated to reposition the fixation device 14 so that the leaflets are properly contacted or grasped at a desired location. Repositioning is achieved with the fixation device in the open position. In some instances, regurgitation may also be checked while the device 14 is in the open position. If regurgitation is not satisfactorily reduced, the device may be repositioned and regurgitation checked again until the desired results are achieved.
It may also be desired to invert the fixation device 14 to aid in repositioning or removal of the fixation device 14.
Once the fixation device 14 has been positioned in a desired location against the valve leaflets, the leaflets may then be captured between the proximal elements 16 and the distal elements 18.
After the leaflets have been captured between the proximal and distal elements 16, 18 in a desired arrangement, the distal elements 18 may be locked to hold the leaflets in this position or the fixation device 14 may be returned to or toward a closed position. Such locking will be described in a later section.
As shown in
In an exemplary embodiments, proximal element lines 90 are elongated flexible threads, wire, cable, sutures or lines extending through shaft 12, looped through proximal elements 16, and extending back through shaft 12 to its proximal end. When detachment is desired, one end of each line may be released at the proximal end of the shaft 12 and the other end pulled to draw the free end of the line distally through shaft 12 and through proximal element 16 thereby releasing the fixation device.
While the above described embodiments of the invention utilize a push-to-open, pull-to-close mechanism for opening and closing distal elements 18, it should be understood that a pull-to-open, push-to-close mechanism is equally possible. For example, distal elements 18 may be coupled at their proximal ends to stud 74 rather than to coupling member 19, and legs 68 may be coupled at their proximal ends to coupling member 19 rather than to stud 74. In this example, when stud 74 is pushed distally relative to coupling member 19, distal elements 18 would close, while pulling on stud 74 proximally toward coupling member 19 would open distal elements 18.
B. Covering on Fixation Device
The fixation device 14 may optionally include a covering. The covering may assist in grasping the tissue and may later provide a surface for tissue ingrowth. Ingrowth of the surrounding tissues, such as the valve leaflets, provides stability to the device 14 as it is further anchored in place and may cover the device with native tissue thus reducing the possibility of immunologic reactions. The covering may be comprised of any biocompatible material, such as polyethylene terepthalate, polyester, cotton, polyurethane, expanded polytetrafluoroethylene (ePTFE), silicon, or various polymers or fibers and have any suitable form, such as a fabric, mesh, textured weave, felt, looped or porous structure. Generally, the covering has a low profile so as not to interfere with delivery through an introducer sheath or with grasping and coapting of leaflets or tissue.
The covering 100 may alternatively be comprised of a polymer or other suitable materials dipped, sprayed, coated or otherwise adhered to the surfaces of the fixation device 14. Optionally, the polymer coating may include pores or contours to assist in grasping the tissue and/or to promote tissue ingrowth.
Any of the coverings 100 may optionally include drugs, antibiotics, anti-thrombosis agents, or anti-platelet agents such as heparin, COUMADIN® (Warfarin Sodium), to name a few. These agents may, for example, be impregnated in or coated on the coverings 100. These agents may then be delivered to the grasped tissues surrounding tissues and/or bloodstream for therapeutic effects.
C. Fixation Device Locking Mechanisms
As mentioned previously, the fixation device 14 optionally includes a locking mechanism for locking the device 14 in a particular position, such as an open, closed or inverted position or any position therebetween. It may be appreciated that the locking mechanism includes an unlocking mechanism which allows the device to be both locked and unlocked.
The locking mechanism 106 allows the fixation device 14 to remain in an unlocked position when attached to the interventional tool 10 during grasping and repositioning and then maintain a locked position when left behind as an implant. It may be appreciated, however, that the locking mechanism 106 may be repeatedly locked and unlocked throughout the placement of the fixation device 14 if desired. Once the final placement is determined, the lock line 92 and proximal element lines 90 are removed and the fixation device is left behind.
Deployment of the proximal elements 16, as shown in
D. Additional Embodiments of Fixation Devices
In use, the embodiment of
In a further alternative of the embodiment of
Optionally, the fixation device 14 may include tissue retention features such as barbs 170 and/or bumpers 172, illustrated in
It may be appreciated that when the fixation device 14 is mounted on the shaft 12 in orientation illustrated in
In the open position, tissue or leaflets may be grasped between the distal elements 18 and proximal elements 16.
To attach the implant pledgets 210 to the leaflets, the leaflets and implant pledgets 210 are punctured by fixation tools 220, as shown in
Referring now to
The implant pledgets 210 are then separated from the fixation device 14 and left behind to maintain coaptation of the leaflets in the desired position.
It may be appreciated that the foregoing embodiment may also include proximal elements 16 configured to be positioned on the upstream side of the valve leaflets to assist in the capture and fixation. Such proximal elements may be mounted to shaft 12 so as to be removed following fixation of the leaflets, or the proximal elements may be connected to distal elements 18 and/or retention clip 36 to be implanted therewith.
In further embodiments, the proximal elements may be manipulated to enhance gripping. For example, the proximal elements may be lowered to grasp leaflets or tissue between the proximal and distal elements, and then the proximal elements may be moved to drag the leaflets or tissue into the fixation device. In another example, the proximal elements may be independently lowered to grasp the leaflets or tissue. This may be useful for sequential grasping. In sequential grasping, one proximal element is lowered to capture a leaflet or tissue portion between the proximal and distal elements. The fixation device is then moved, adjusted or maneuvered to a position for grasping another leaflet or tissue portion between another set of proximal and distal elements. In this position, the second proximal element is then lowered to grasp this other leaflet or tissue portion.
IV. Delivery Device
A. Overview of Delivery Device
Referring back to
Referring back to
B. Delivery Catheter Shaft
Passing through the support coil 346 are a variety of elongated bodies, including tubular guides and cylindrical rods. For example, one type of tubular guide is a compression coil 326 extending through lumen 348 from the proximal end 322 to the distal end 324 of the shaft 302, and the actuator rod 64 extends through the compression coil 326. Therefore, the compression coil typically has a length in the range of 48 to 60 in. and an inner diameter in the range of 0.020 to 0.035 in. to allow passage of the actuator rod 64 therethrough. The actuator rod 64 is manipulable to rotate and translate within and relative to the compression coil 326. The compression coil 326 allows lateral flexibility of the actuator rod 64 and therefore the shaft 302 while resisting buckling and providing column strength under compression. The compression coil may be comprised of 304V stainless steel to provide these properties.
To provide additional tensile strength for the shaft 302 and to minimize elongation, a tension cable 344 may also pass through the support coil 346. The tension cable 344 extends through lumen 348 from the proximal end 322 to the distal end 324 of the shaft 302. Therefore, the tension cable 344 typically has a diameter in the range of 0.005 in. to 0.010 in. and a length in the range of 48 to 60 in. In preferred embodiments, the tension cable 344 is comprised of 304V stainless steel.
In addition, at least one lock line shaft 341 having a tubular shape may be present having a lock line lumen 340 through which lock lines 92 pass between the lock line handle 310 and the locking mechanism 106. The lock line shaft 341 extends through lumen 348 from the proximal end 322 to the distal end 324 of the shaft 302. Therefore, the lock line shaft 341 typically has a length in the range of 48 to 60 in., an inner diameter in the range of 0.016 to 0.030 in., and an outer diameter in the range of 0.018 to 0.034 in. In preferred embodiments, the lock line shaft 341 is comprised of a 304V stainless steel coil however other structures or materials may be used which provide kink resistance and compression strength.
Similarly, at least one proximal element line shaft 343 having a tubular shape may be present having a proximal element line lumen 342. Proximal element lines 90 pass through this lumen 342 between the proximal element line handle 312 and the proximal elements 16. Thus, the proximal element line shaft 343 extends through lumen 348 from the proximal end 322 to the distal end 324 of the shaft 302. Therefore, the proximal element line shaft 343 typically has a length in the range of 48 to 60 in., an inner diameter in the range of 0.016 to 0.030 in., and an outer diameter in the range of 0.018 to 0.034 in. In preferred embodiments, the proximal element line shaft 343 is comprised of a 304V stainless steel coil however other structures or materials may be used which provide kink resistance and compression strength.
In this embodiment, the elongated bodies (compression coil 326 enclosed actuator rod 64, tension cable 344, lock line shaft 342, proximal element line shaft 343) each “float” freely in inner lumen 348 within the support coil 346 and are fixed only at the proximal end 322 and distal end 324 of shaft 302. The lumen 348 is typically filled and flushed with heparinized saline during use. Alternatively or in addition, the lumen 348 may be filled with one or more fillers, such as flexible rods, beads, extruded sections, gels or other fluids. Preferably the fillers allow for some lateral movement or deflection of the elongated bodies within lumen 348 but in some cases may restrict such movement. Typically, the elongated bodies are fixed at the proximal and distal ends of the shaft and are free to move laterally and rotationally therebetween. Such freedom of movement of the elongated bodies provides the shaft 302 with an increased flexibility as the elongated bodies self-adjust and reposition during bending and/or torquing of the shaft 302. It may be appreciated that the elongated bodies may not be fixed at the proximal and distal ends. The elongated bodies are simply unconstrained relative to the shaft 302 in at least one location so as to be laterally moveable within the lumen 348. Preferably the elongated bodies are unrestrained in at least a distal portion of the catheter, e.g. 5-15 cm from the distal end 324, so as to provide maximum flexibility in the distal portion.
It may be appreciated, however, that alternate shaft 302 designs may also be used. For example, referring to
Alternatively, as shown in
C. Lock Line Arrangements
As mentioned previously, when lock lines 92 are present, the lines 92 pass through at least one lock line lumen 340 between the lock line handle 310 and the locking mechanism 106. The lock lines 92 engage the release harnesses 108 of the locking mechanism 106 to lock and unlock the locking mechanism 106 as previously described. The lock lines 92 may engage the release harnesses 108 in various arrangements, examples of which are illustrated in
It may be appreciated that a variety of lock line arrangements may be used and are not limited to the arrangements illustrated and described above. The various arrangements allow the harnesses 108 to be manipulated independently or jointly, allow various amounts of tension to be applied and vary the force required for removal of the lock lines when the fixation device is to be left behind. For example, a single lock line passing through one or two lumens may be connected to both release harnesses for simultaneous application of tension.
D. Proximal Element Line Arrangements
As mentioned previously, when proximal element lines 90 are present, the lines 90 pass through at least one proximal element line lumen 342 between the proximal element line handle 312 and at least one proximal element 16. The proximal element lines 90 engage the proximal elements 16 to raise or lower the element 16 as previously described. The proximal element lines 90 may engage the proximal elements 16 in various arrangements, examples of which are illustrated in
It may be appreciated that a variety of proximal element line arrangements may be used and are not limited to the arrangements illustrated and described above. The various arrangements allow the proximal elements to be manipulated independently or jointly, allow various amounts of tension to be applied and vary the force required for removal of the proximal element lines when the fixation device is to be left behind. For example, a single proximal element line passing through one or two lumens in shaft 302 may be used for simultaneous actuation of both proximal elements.
E. Main Body of Handle
F. Lock Line Handle and Proximal Element Line Handle
As mentioned previously, the lock lines 92 may be may be extended, retracted, loaded with various amounts of tension or removed using the lock line handle 310. Likewise, the proximal element lines 90 may be extended, retracted, loaded with various amounts of tension or removed using the proximal element line handle 312. Both of these handles 310, 312 may be similarly designed to manipulate the appropriate lines 90, 92 passing therethrough.
Disposed near the distal end 384 of the handle 310 is at least one wing 392. In the embodiment of
The portion of the wings 392 parallel to the elongate shaft 383 have grooves or serrations 394. The serrations 394 are used to apply tension to the lock lines 92. As shown in
To remove the lock lines 92, the cap 388 is removed from the threaded nub 390 exposing the free ends of the lock lines 92. If one lock line 92 is present having two free ends, continuous pulling on one of the free ends draws the entire length of lock line 92 out of the catheter 300. If more than one lock line 92 is present, each lock line 92 will have two free ends. Continuous pulling on one of the free ends of each lock line 92 draws the entire length of each lock line 92 out of the catheter 300.
It may be appreciated that the proximal element line handle 312 has corresponding features to the lock line handle 310 and operates in the same manner as illustrated in
G. Actuator Rod Control and Handle
The actuator rod 64 may be manipulated using the actuator rod control 314 and the actuator rod handle 316.
Referring to
Referring to
Depending on the application, the location of the target site, and the approach selected, the devices of the invention may be modified in ways well known to those of skill in the art or used in conjunction with other devices that are known in the art. For example, the delivery catheter may be modified in length, stiffness, shape and steerability for a desired application. Likewise, the orientation of the fixation device relative to the delivery catheter may be reversed or otherwise changed. The actuation mechanisms may be changed to be driven in alternate directions (push to open, pull to close, or pull to open, push to close). Materials and designs may be changed to be, for example, more flexible or more rigid. And, the fixation device components may be altered to those of different size or shape. Further, the delivery catheter of the present invention may be used to deliver other types of devices, particularly endovascular and minimally invasive surgical devices used in angioplasty, atherectomy, stent-delivery, embolic filtration and removal, septal defect repair, tissue approximation and repair, vascular clamping and ligation, suturing, aneurysm repair, vascular occlusion, and electrophysiological mapping and ablation, to name a few. Thus, the delivery catheter of the present invention may be used for applications in which a highly flexible, kink-resistant device is desirable with high compressive, tensile and torsional strength.
V. Multi-Catheter Guiding System
A. Overview of Guiding System
Referring to
The outer guide catheter 1000 and/or the inner guide catheter 1020 are precurved and/or have steering mechanisms, embodiments of which will be described later in detail, to position the distal ends 1016, 1026 in desired directions. Precurvature or steering of the outer guide catheter 1000 directs the distal end 1016 in a first direction to create a primary curve while precurvature and/or steering of the inner guide catheter 1020 directs distal end 1026 in a second direction, differing from the first, to create a secondary curve. Together, the primary and secondary curves form a compound curve. Advancement of the interventional catheter 1030 through the coaxial guide catheters 1000, 1020 guides the interventional catheter 1030 through the compound curve toward a desired direction, usually in a direction which will allow the interventional catheter 1030 to reach its target.
Steering of the outer guide catheter 1000 and inner guide catheter 1020 may be achieved by actuation of one or more steering mechanisms. Actuation of the steering mechanisms is achieved with the use of actuators which are typically located on handles connected with each of the catheters 1000, 1020. As illustrated in
In addition, locking actuators 1058, 1060 may be used to actuate locking mechanisms to lock the catheters 1000, 1020 in a particular position. Actuators 1050, 1052, 1058, 1060 are illustrated as buttons, however it may be appreciated that these and any additional actuators located on the handles 1056, 1057 may have any suitable form including knobs, thumbwheels, levers, switches, toggles, sensors or other devices. Other embodiments of the handles will be described in detail in a later section.
In addition, the handle 1056 may include a numerical or graphical display 1061 of information such as data indicating the position the catheters 1000, 1020, or force on actuators. It may also be appreciated that actuators 1050, 1052, 1058, 1060 and any other buttons or screens may be disposed on a single handle which connects with both the catheters 1000, 1020.
B. Example Positions
Referring to
Referring now to
Similarly,
In addition, the outer guide catheter 1000 may be pre-formed and/or steerable to provide additional curves or shapes. For example, as illustrated in
The articulated position of the multi-catheter guiding system 1 illustrated in
Referring to
Referring to
In some instances, it is desired to raise or lower the distal end 1026 so that it is at a desired height in relation to the mitral valve MV. This may be accomplished by precurvature and/or by steering of the outer guide catheter 1000 to form additional curve 1110. Generally this is used to lift the distal end 1026 above the mitral MV wherein such lifting was illustrated in
When the curvatures in the catheters 1000, 1020 are formed by steering mechanisms, the steering mechanisms may be locked in place by a locking feature. Locking can provide additional stiffness and stability in the guiding system 1 for the passage of interventional devices or catheters 1030 therethrough, as illustrated in
C. Steering Mechanisms
As described previously, the curvatures may be formed in the catheters 1000, 1020 by precurving, steering or any suitable means. Precurving involves setting a specific curvature in the catheter prior to usage, such as by heat setting a polymer or by utilizing a shape-memory alloy. Since the catheters are generally flexible, loading of the catheter on a guidewire, dilator obturator or other introductory device straightens the catheter throughout the curved region. Once the catheter is positioned in the anatomy, the introductory device is removed and the catheter is allowed to relax back into the precurved setting.
To provide a higher degree of control and variety of possible curvatures, steering mechanisms may be used to create the curvatures and position the catheters. In some embodiments, the steering mechanisms comprise cables or pullwires within the wall of the catheter. As shown in
Such pullwires 1120 and/or pullwires 1120′ and associated lumens may be placed in any arrangement, singly or in pairs, symmetrically or nonsymmetrically and any number of pullwires may be present. This may allow curvature in any direction and about various axes. The pullwires 1120, 1120′ may be fixed at any location along the length of the catheter by any suitable method, such as gluing, tying, soldering, or potting, to name a few. When tension is applied to the pullwire, the curvature forms from the point of attachment of the pullwire toward the proximal direction. Therefore, curvatures may be formed throughout the length of the catheter depending upon the locations of the points of attachment of the pullwires. Typically, however, the pullwires will be attached near the distal end of the catheter, optionally to an embedded tip ring 280, illustrated in
D. Catheter Construction
The outer guide catheter 1000 and inner guide catheter 1020 may have the same or different construction which may include any suitable material or combination of materials to create the above described curvatures. For clarity, the examples provided will be in reference to the outer guide catheter 1000, however it may be appreciated that such examples may also apply to the inner guide catheter 1020.
In embodiments in which the catheter is precurved rather than steerable or in addition to being steerable, the catheter 1000 may be comprised of a polymer or copolymer which is able to be set in a desired curvature, such as by heat setting. Likewise, the catheter 1000 may be comprised of a shape-memory alloy.
In embodiments in which the catheter is steerable, the catheter 1000 may be comprised of one or more of a variety of materials, either along the length of the catheter 1000 or in various segments. Example materials include polyurethane, Pebax, nylon, polyester, polyethylene, polyimide, polyethylenetelephthalate (PET), polyetheretherketone (PEEK). In addition, the walls of the catheter 1000 may be reinforced with a variety of structures, such as metal braids or coils. Such reinforcements may be along the length of the catheter 1000 or in various segments.
For example, referring to
Thus, the keying feature may be present along one or more specific portions of the catheters 1000, 1020 or may extend along the entire length of the catheters 1000, 1020. Likewise, the notches 1402 may extend along the entire length of the outer guiding catheter 1020 while the protrusions 1400 extend along discrete portions of the inner guiding catheter 1000 and vice versa. It may further be appreciated that the protrusions 1400 may be present on the inner surface of the outer guiding catheter 1000 while the notches 1402 are present along the outer surface of the inner guiding catheter 1020.
Alternatively or in addition, one or more steerable portions of the catheter 1000 may comprise a series of articulating members 1180 as illustrated in
Briefly, referring to
The interfitting domed rings 1184 are connected by at least one pullwire 1120. Such pullwires typically extend through the length of the catheter 1000 and at least one of the interfitting domed rings 1184 to a fixation point where the pullwire 1120 is fixedly attached. By applying tension to the pullwire 1120, the pullwire 1120 arcs the series of interfitting domed rings 1184 proximal to the attachment point to form a curve. Thus, pulling or applying tension on at least one pullwire, steers or deflects the catheter 1000 in the direction of that pullwire 1120. By positioning various pullwires 1120 throughout the circumference of the domed rings 1184, the catheter 1000 may be directed in any number of directions.
Also shown in
E. Handles
As mentioned previously, manipulation of the guide catheters 1000, 1020 is achieved with the use of handles 1056, 1057 attached to the proximal ends of the catheters 1000, 1020.
Each handle 1056, 1057 includes two steering knobs 1300a, 1300b emerging from a handle housing 1302 for manipulation by a user. Steering knobs 1300a are disposed on a side of the housing 1302 and steering knobs 1300b are disposed on a face of the housing 1302. However, it may be appreciated that such placement may vary based on a variety of factors including type of steering mechanism, size and shape of handle, type and arrangement of parts within handle, and ergonomics to name a few.
The knob gear wheel 1310 is a toothed wheel that engages a disk gear wheel 1312. Rotation of the steering knob 1300a rotates the knob post 1318 and knob gear wheel 1310 which in turn rotates the disk gear wheel 1312. Rotation of the disk gear wheel 1312 applies tension to one or more pullwires extending through the attached catheter, in this example the outer guiding catheter 1000. As shown, the outer guiding catheter 1000 passes through the base 1308, wherein one or more pullwires 1120 extending through the catheter 1000 are attached to the disk 1314. Such attachment is schematically illustrated in
In some instances, it is desired to restrict rotation of the disk 1314 to a degree of rotation which is more than 360 degrees. This may be achieved with another embodiment of the hard stop gear assembly 1304. Referring now to
Referring now to
It may be appreciated that one or more pullwires 1120 are attached to the disk 1314 in a manner similar to that illustrated in
As mentioned, each steering mechanism includes at least a hard stop gear assembly 1304 and a friction assembly 1306. As described above, tension is applied to one or more pullwires by action of the hard stop gear assembly to form a curve in a catheter. Tension is maintained by the friction assembly.
The steering knob 1300b and knob post 1318 are held in a rotated position by friction provided by a frictional pad 1370. The frictional pad 1370 is positioned between ring 1372 attached to the knob post 1318 and a plate 1374 attached to the base 1308. The knob post 1318 extends from the knob 1300b through the ring 1372, the frictional pad 1370 and then the plate 1374. The plate 1374 has internal threads which mate with threads on the knob post 1318. As the knob post 1318 rotates, the threads on the post 1318 advance through the threads on the plate 1374. This draws the ring 1372 closer to the plate 1374, compressing the frictional pad 1370 therebetween. Frictional pad 1370 may be comprised of any O-ring or sheet material with desirable frictional and compressibility characteristics, such as silicone rubber, natural rubber or synthetic rubbers, to name a few. In preferred embodiments, an EPDM rubber O-ring is used. Reverse rotation of the knob post 1318 is resisted by friction of the frictional pad 1370 against the ring 1372. The higher the compression of the frictional pad 1370 the stronger the frictional hold. Therefore, as the steering knob 1300b is rotated and increasing amounts of tension are applied to the pullwires 1120, increasing amounts of friction are applied to the ring 1372 to hold the knob 1300b in place.
Manual reverse rotation of the steering knob 1300b releases tension on the pullwires 1120 and draws the ring 1372 away from the plate 1374 thereby reducing the frictional load. When tension is released from the pullwires 1120 the catheter 1000 returns toward a straightened position.
It may be appreciated that each handle 1056, 1057 includes a steering mechanism for each curve to be formed in the attached catheter. Thus, as shown in
Some curves, such as the primary curve 1100, secondary curve 1104 and additional curve 1110 each typically vary in curvature between a straight configuration and a curved configuration in a single direction. Such movement may be achieved with single set of a hard stop gear assembly 1304 and a friction assembly 1306. However, other curves, such as the angle theta 1070, may be formed in two directions as shown in
It may be appreciated that various other mechanisms may be used for tensioning and holding pullwires 1120 in place. Example mechanisms that may alternatively be used include clutches, ratchets, levers, knobs, rack and pinions, and deformable handles, to name a few.
F. Interventional System
To assist in inserting the fixation device 14 through a hemostatic valve 1090, a fixation device introducer may be used. For example, when the fixation device 14 is loaded on a delivery catheter 300 and an inner guide catheter 1020, insertion of the fixation device 14, delivery catheter 300 and inner guide catheter 1020 through an outer guide catheter 1000 involves passing the fixation device 14 through a hemostatic valve 1090 on the outer guide catheter 1000. To reduce any trauma to the fixation device 14 by the hemostatic valve 1090, a fixation device introducer may be used. An embodiment of a fixation device introducer 1420 is illustrated in
Manipulation of the guide catheters 1000, 1020 is achieved with the use of handles 1056, 1057 attached to the proximal ends of the catheters 1000, 1020. As shown, handle 1056 is attached to the proximal end 1014 of outer guide catheter 1000 and handle 1057 is attached to the proximal end 1024 of inner guide catheter 1020. Inner guide catheter 1020 is inserted through handle 1056 and is positioned coaxially within outer guide catheter 1000.
An embodiment of the delivery catheter 300 of the present invention is inserted through handle 1057 and is positioned coaxially within inner guide catheter 1020 and outer guide catheter 1000. Therefore, a hemostatic valve 1090 is disposed within handle 1057 or external to handle 1057 as shown to provide leak-free sealing with or without the delivery catheter 300 in place. The valve 1090 functions as described above. The delivery catheter 300 includes a shaft 302, having a proximal end 322 and a distal end 324, and a handle 304 attached to the proximal end 322. A fixation device 14 is removably coupled to the distal end 324 for delivery to a site within the body.
The outer guide catheter 1000 and/or the inner guide catheter 1020 are precurved and/or have steering mechanisms to position the distal ends 1016, 1026 in desired directions. Precurvature or steering of the outer guide catheter 1000 directs the distal end 1016 in a first direction to create a primary curve while precurvature and/or steering of the inner guide catheter 1020 directs distal end 1026 in a second direction, differing from the first, to create a secondary curve. Together, the primary and secondary curves form a compound curve. Advancement of the delivery catheter 300 through the coaxial guide catheters 1000, 1020 guides the delivery catheter 300 through the compound curve toward a desired direction, usually in a direction which will position the fixation device 14 in a desired location within the body.
It may be appreciated the above described systems 3 are not intended to limit the scope of the present invention. The systems 3 may include any or all of the components of the described invention. In addition, the multi-catheter guiding system 1 of the present invention may be used to introduce other delivery catheters, interventional catheters or other devices. Likewise, the delivery catheter 300 may be introduced through other introducers or guiding systems. Also, the delivery catheter 300 may be used to deliver other types of devices to a target location within the body, including endoscopic staplers, devices for electrophysiology mapping or ablation, septal defect repair devices, heart valves, annuloplasty rings and others.
In addition, many of the components of the system 3 may include one or more hydrophilic coatings. Hydrophilic coatings become slippery when wet, eliminate the need for separate lubricants. Thus, such coatings may be present on the multi-catheter guiding system, delivery catheter, and fixation device, including the proximal elements and distal elements, to name a few.
Further, the system 3 may be supported by an external stabilizer base 1440, an embodiment of which is illustrated in
It may be appreciated that the stabilizer base 1440 may take a variety of forms and may include differences in structural design to accommodate various types, shapes, arrangements and numbers of handles.
G. Kits
Referring now to
While the foregoing is a complete description of the preferred embodiments of the invention, various alternatives, substitutions, additions, modifications, and equivalents are possible without departing from the scope of the invention. For example, in many of the above-described embodiments, the invention is described in the context of approaching a valve structure from the upstream side—that is, the atrial side in the case of a mitral valve. It should be understood that any of the foregoing embodiments may be utilized in other approaches as well, including from the ventricular or downstream side of the valve, as well as using surgical approaches through a wall of the heart. Moreover, the invention may be used in the treatment of a variety of other tissue structures besides heart valves, and will find usefulness in a variety of tissue approximation, attachment, closure, clamping and ligation applications, some endovascular, some endoscopic, and some open surgical.
Again, although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that various alternatives, modifications and equivalents may be used and the above description should not be taken as limiting in scope of the invention which is defined by the appended claims.
This application is a continuation of U.S. patent application Ser. No. 15/483,523 filed Apr. 10, 2017, which is a continuation of U.S. patent application Ser. No. 15/334,992 filed Oct. 26, 2016, which is a continuation of U.S. patent application Ser. No. 14/259,826, now U.S. Pat. No. 9,510,829, filed Apr. 23, 2014, which is a divisional of U.S. patent application Ser. No. 13/899,901, now U.S. Pat. No. 8,740,920, filed May 22, 2013, which is a continuation of U.S. patent application Ser. No. 12/636,471, now U.S. Pat. No. 8,500,761, filed Dec. 11, 2009, which is a continuation of, and claims the benefit of priority from U.S. application Ser. No. 11/962,654, now U.S. Pat. No. 7,655,015, filed Dec. 21, 2007, which is a divisional of U.S. patent application Ser. No. 10/441,531, now U.S. Pat. No. 7,563,267, filed May 19, 2003, the full disclosures of which are hereby incorporated herein by reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 2097018 | Chamberlain | Oct 1937 | A |
| 2108206 | Meeker | Feb 1938 | A |
| 3296668 | Aiken | Jan 1967 | A |
| 3378010 | Codling et al. | Apr 1968 | A |
| 3557780 | Sato | Jan 1971 | A |
| 3671979 | Moulopoulos | Jun 1972 | A |
| 3675639 | Cimber | Jul 1972 | A |
| 3874338 | Happel | Apr 1975 | A |
| 3874388 | King et al. | Apr 1975 | A |
| 4007743 | Blake | Feb 1977 | A |
| 4055861 | Carpentier et al. | Nov 1977 | A |
| 4056854 | Boretos et al. | Nov 1977 | A |
| 4064881 | Meredith | Dec 1977 | A |
| 4091815 | Larsen | May 1978 | A |
| 4112951 | Hulka et al. | Sep 1978 | A |
| 4235238 | Ogiu et al. | Nov 1980 | A |
| 4297749 | Davis et al. | Nov 1981 | A |
| 4327736 | Inoue | May 1982 | A |
| 4340091 | Skelton et al. | Jul 1982 | A |
| 4458682 | Cerwin | Jul 1984 | A |
| 4425908 | Simon | Nov 1984 | A |
| 4484579 | Meno et al. | Nov 1984 | A |
| 4487205 | Di Giovanni et al. | Dec 1984 | A |
| 4498476 | Cerwin et al. | Feb 1985 | A |
| 4510934 | Batra | Apr 1985 | A |
| 4531522 | Bedi et al. | Jul 1985 | A |
| 4578061 | Lemelson | Mar 1986 | A |
| 4641366 | Yokoyama et al. | Feb 1987 | A |
| 4657024 | Coneys | Apr 1987 | A |
| 4686963 | Cohen et al. | Aug 1987 | A |
| 4686965 | Bonnet et al. | Aug 1987 | A |
| 4693248 | Failla | Sep 1987 | A |
| 4716886 | Schulman et al. | Jan 1988 | A |
| 4742817 | Kawashima et al. | May 1988 | A |
| 4777951 | Cribier et al. | Oct 1988 | A |
| 4795458 | Regan | Jan 1989 | A |
| 4809695 | Gwathmey et al. | Mar 1989 | A |
| 4887601 | Richards | Dec 1989 | A |
| 4917089 | Sideris | Apr 1990 | A |
| 4930674 | Barak | Jun 1990 | A |
| 4944295 | Gwathmey et al. | Jul 1990 | A |
| 4969890 | Sugita et al. | Nov 1990 | A |
| 4994077 | Dobben | Feb 1991 | A |
| 5002562 | Oberlander | Mar 1991 | A |
| 5015249 | Nakao et al. | May 1991 | A |
| 5019096 | Fox, Jr. et al. | May 1991 | A |
| 5042707 | Taheri | Aug 1991 | A |
| 5047041 | Samuels | Sep 1991 | A |
| 5049153 | Nakao et al. | Sep 1991 | A |
| 5061277 | Carpentier et al. | Oct 1991 | A |
| 5069679 | Taheri | Dec 1991 | A |
| 5098440 | Hillstead | Mar 1992 | A |
| 5108368 | Hammerslag et al. | Apr 1992 | A |
| 5125758 | DeWan | Jun 1992 | A |
| 5125895 | Buchbinder et al. | Jun 1992 | A |
| 5147370 | McNamara et al. | Sep 1992 | A |
| 5171252 | Friedland | Dec 1992 | A |
| 5171259 | Inoue | Dec 1992 | A |
| 5190554 | Coddington et al. | Mar 1993 | A |
| 5195968 | Lundquist et al. | Mar 1993 | A |
| 5209756 | Seedhom et al. | May 1993 | A |
| 5222963 | Brinkerhoff et al. | Jun 1993 | A |
| 5226429 | Kuzmak | Jul 1993 | A |
| 5226911 | Chee et al. | Jul 1993 | A |
| 5234437 | Sepetka | Aug 1993 | A |
| 5242456 | Nash et al. | Sep 1993 | A |
| 5250071 | Palermo | Oct 1993 | A |
| 5251611 | Zehel et al. | Oct 1993 | A |
| 5254130 | Poncet et al. | Oct 1993 | A |
| 5261916 | Engelson | Nov 1993 | A |
| 5271381 | Ailinger et al. | Dec 1993 | A |
| 5271544 | Fox et al. | Dec 1993 | A |
| 5275578 | Adams | Jan 1994 | A |
| 5282845 | Bush et al. | Feb 1994 | A |
| 5304131 | Paskar | Apr 1994 | A |
| 5306283 | Conners | Apr 1994 | A |
| 5306286 | Stack et al. | Apr 1994 | A |
| 5312415 | Palermo | May 1994 | A |
| 5314424 | Nicholas | May 1994 | A |
| 5318525 | West et al. | Jun 1994 | A |
| 5320632 | Heidmueller | Jun 1994 | A |
| 5325845 | Adair | Jul 1994 | A |
| 5327905 | Avitall | Jul 1994 | A |
| 5330442 | Green et al. | Jul 1994 | A |
| 5330501 | Tovey et al. | Jul 1994 | A |
| 5332402 | Teitelbaum | Jul 1994 | A |
| 5334217 | Das | Aug 1994 | A |
| 5342393 | Stack | Aug 1994 | A |
| 5350397 | Palermo et al. | Sep 1994 | A |
| 5350399 | Erlebacher et al. | Sep 1994 | A |
| 5359994 | Kreuter et al. | Nov 1994 | A |
| 5363861 | Edwards et al. | Nov 1994 | A |
| 5368564 | Savage | Nov 1994 | A |
| 5368601 | Sauer et al. | Nov 1994 | A |
| 5383886 | Kensey et al. | Jan 1995 | A |
| 5389077 | Melinyshyn et al. | Feb 1995 | A |
| 5391182 | Chin | Feb 1995 | A |
| 5403312 | Yates et al. | Apr 1995 | A |
| 5403326 | Harrison et al. | Apr 1995 | A |
| 5411552 | Andersen et al. | May 1995 | A |
| 5413584 | Schulze | May 1995 | A |
| 5417699 | Klein et al. | May 1995 | A |
| 5417700 | Egan | May 1995 | A |
| 5423857 | Rosenman et al. | Jun 1995 | A |
| 5423858 | Bolanos et al. | Jun 1995 | A |
| 5423882 | Jackman et al. | Jun 1995 | A |
| 5425744 | Fagan et al. | Jun 1995 | A |
| 5431666 | Sauer et al. | Jul 1995 | A |
| 5437551 | Chalifoux | Aug 1995 | A |
| 5437681 | Meade et al. | Aug 1995 | A |
| 5447966 | Hermes et al. | Sep 1995 | A |
| 5450860 | O'Connor | Sep 1995 | A |
| 5452837 | Williamson, IV et al. | Sep 1995 | A |
| 5456400 | Schichman et al. | Oct 1995 | A |
| 5456674 | Bos et al. | Oct 1995 | A |
| 5456684 | Schmidt et al. | Oct 1995 | A |
| 5462527 | Stevens-Wright et al. | Oct 1995 | A |
| 5472044 | Hall et al. | Dec 1995 | A |
| 5476470 | Fitzgibbons, Jr. | Dec 1995 | A |
| 5477856 | Lundquist | Dec 1995 | A |
| 5478309 | Sweezer et al. | Dec 1995 | A |
| 5478353 | Yoon | Dec 1995 | A |
| 5487746 | Yu et al. | Jan 1996 | A |
| 5496332 | Sierra et al. | Mar 1996 | A |
| 5507725 | Savage et al. | Apr 1996 | A |
| 5507755 | Gresl et al. | Apr 1996 | A |
| 5507757 | Sauer et al. | Apr 1996 | A |
| 5520701 | Lerch | May 1996 | A |
| 5522873 | Jackman et al. | Jun 1996 | A |
| 5527313 | Scott et al. | Jun 1996 | A |
| 5527321 | Hinchliffe | Jun 1996 | A |
| 5527322 | Klein et al. | Jun 1996 | A |
| 5536251 | Evard et al. | Jul 1996 | A |
| 5540705 | Meade et al. | Jul 1996 | A |
| 5542949 | Yoon | Aug 1996 | A |
| 5554185 | Block et al. | Sep 1996 | A |
| 5562678 | Booker | Oct 1996 | A |
| 5569274 | Rapacki et al. | Oct 1996 | A |
| 5571085 | Accisano, III | Nov 1996 | A |
| 5571137 | Marlow et al. | Nov 1996 | A |
| 5571215 | Sterman et al. | Nov 1996 | A |
| 5575802 | McQuilkin et al. | Nov 1996 | A |
| 5582611 | Tsuruta et al. | Dec 1996 | A |
| 5593424 | Northrup, III | Jan 1997 | A |
| 5593435 | Carpentier et al. | Jan 1997 | A |
| 5601224 | Bishop et al. | Feb 1997 | A |
| 5601574 | Stefanchik et al. | Feb 1997 | A |
| 5607462 | Imran | Mar 1997 | A |
| 5607471 | Seguin et al. | Mar 1997 | A |
| 5609598 | Laufer et al. | Mar 1997 | A |
| 5611794 | Sauer et al. | Mar 1997 | A |
| 5618306 | Roth et al. | Apr 1997 | A |
| 5620452 | Yoon | Apr 1997 | A |
| 5620461 | Muijs Van De Moer et al. | Apr 1997 | A |
| 5626588 | Sauer et al. | May 1997 | A |
| 5634932 | Schmidt | Jun 1997 | A |
| 5636634 | Kordis et al. | Jun 1997 | A |
| 5639277 | Mariant et al. | Jun 1997 | A |
| 5640955 | Ockuly et al. | Jun 1997 | A |
| 5649937 | Bito et al. | Jul 1997 | A |
| 5662681 | Nash et al. | Sep 1997 | A |
| 5669917 | Sauer et al. | Sep 1997 | A |
| 5690671 | McGurk et al. | Nov 1997 | A |
| 5695504 | Gifford, III et al. | Dec 1997 | A |
| 5695505 | Yoon | Dec 1997 | A |
| 5702825 | Keita et al. | Dec 1997 | A |
| 5706824 | Whittier | Jan 1998 | A |
| 5709707 | Lock et al. | Jan 1998 | A |
| 5713910 | Gordon et al. | Feb 1998 | A |
| 5713911 | Racenet et al. | Feb 1998 | A |
| 5715817 | Stevens-Wright et al. | Feb 1998 | A |
| 5716367 | Koike et al. | Feb 1998 | A |
| 5716417 | Girard et al. | Feb 1998 | A |
| 5718725 | Sterman et al. | Feb 1998 | A |
| 5719725 | Nakao | Feb 1998 | A |
| 5722421 | Francese et al. | Mar 1998 | A |
| 5725542 | Yoon | Mar 1998 | A |
| 5725556 | Moser et al. | Mar 1998 | A |
| 5738649 | Macoviak | Apr 1998 | A |
| 5741280 | Fleenor | Apr 1998 | A |
| 5741297 | Simon | Apr 1998 | A |
| 5749828 | Solomon et al. | May 1998 | A |
| 5755778 | Kleshinski | May 1998 | A |
| 5759193 | Burbank et al. | Jun 1998 | A |
| 5769812 | Stevens et al. | Jun 1998 | A |
| 5769863 | Garrison | Jun 1998 | A |
| 5772578 | Heimberger et al. | Jun 1998 | A |
| 5782239 | Webster, Jr. | Jul 1998 | A |
| 5782845 | Shewchuk | Jul 1998 | A |
| 5797927 | Yoon | Aug 1998 | A |
| 5797960 | Stevens et al. | Aug 1998 | A |
| 5810847 | Laufer et al. | Sep 1998 | A |
| 5810849 | Kontos | Sep 1998 | A |
| 5810853 | Yoon | Sep 1998 | A |
| 5810876 | Kelleher | Sep 1998 | A |
| 5814029 | Hassett | Sep 1998 | A |
| 5814097 | Sterman et al. | Sep 1998 | A |
| 5820592 | Hammerslag | Oct 1998 | A |
| 5820631 | Nobles | Oct 1998 | A |
| 5823955 | Kuck et al. | Oct 1998 | A |
| 5823956 | Roth et al. | Oct 1998 | A |
| 5824065 | Gross | Oct 1998 | A |
| 5827237 | Macoviak et al. | Oct 1998 | A |
| 5829447 | Stevens et al. | Nov 1998 | A |
| 5833671 | Macoviak et al. | Nov 1998 | A |
| 5836955 | Buelna et al. | Nov 1998 | A |
| 5840081 | Andersen et al. | Nov 1998 | A |
| 5843031 | Hermann et al. | Dec 1998 | A |
| 5843178 | Vanney et al. | Dec 1998 | A |
| 5849019 | Yoon | Dec 1998 | A |
| 5853422 | Huebsch et al. | Dec 1998 | A |
| 5855271 | Eubanks et al. | Jan 1999 | A |
| 5855590 | Malecki et al. | Jan 1999 | A |
| 5855601 | Bessler et al. | Jan 1999 | A |
| 5855614 | Stevens et al. | Jan 1999 | A |
| 5860990 | Nobles et al. | Jan 1999 | A |
| 5861003 | Latson et al. | Jan 1999 | A |
| 5868733 | Ockuly et al. | Feb 1999 | A |
| 5876399 | Chia et al. | Mar 1999 | A |
| 5879307 | Chio et al. | Mar 1999 | A |
| 5885258 | Sachdeva et al. | Mar 1999 | A |
| 5885271 | Hamilton et al. | Mar 1999 | A |
| 5891160 | Williamson, IV et al. | Apr 1999 | A |
| 5916147 | Boury | Jun 1999 | A |
| 5928224 | Laufer | Jul 1999 | A |
| 5944733 | Engelson | Aug 1999 | A |
| 5947363 | Bolduc et al. | Sep 1999 | A |
| 5954732 | Hart et al. | Sep 1999 | A |
| 5957949 | Leonhard et al. | Sep 1999 | A |
| 5972020 | Carpentier et al. | Oct 1999 | A |
| 5972030 | Garrison et al. | Oct 1999 | A |
| 5976159 | Bolduc et al. | Nov 1999 | A |
| 5980455 | Daniel et al. | Nov 1999 | A |
| 5989284 | Laufer | Nov 1999 | A |
| 6007552 | Fogarty et al. | Dec 1999 | A |
| 6015417 | Reynolds, Jr. | Jan 2000 | A |
| 6017358 | Yoon et al. | Jan 2000 | A |
| 6019722 | Spence et al. | Feb 2000 | A |
| 6022360 | Reimels et al. | Feb 2000 | A |
| 6033378 | Lundquist et al. | Mar 2000 | A |
| 6036699 | Andreas et al. | Mar 2000 | A |
| 6048351 | Gordon et al. | Apr 2000 | A |
| 6056769 | Epstein et al. | May 2000 | A |
| 6059757 | Macoviak et al. | May 2000 | A |
| 6060628 | Aoyama et al. | May 2000 | A |
| 6060629 | Pham et al. | May 2000 | A |
| 6063106 | Gibson | May 2000 | A |
| 6066146 | Carroll et al. | May 2000 | A |
| 6068628 | Fanton et al. | May 2000 | A |
| 6068629 | Haissaguerre et al. | May 2000 | A |
| 6077214 | Mortier et al. | Jun 2000 | A |
| 6079414 | Roth | Jun 2000 | A |
| 6086600 | Kortenbach | Jul 2000 | A |
| 6088889 | Luther et al. | Jul 2000 | A |
| 6099505 | Ryan et al. | Aug 2000 | A |
| 6099553 | Hart et al. | Aug 2000 | A |
| 6110145 | Macoviak | Aug 2000 | A |
| 6117144 | Nobles et al. | Sep 2000 | A |
| 6117159 | Huebsch et al. | Sep 2000 | A |
| 6120496 | Whayne et al. | Sep 2000 | A |
| 6123699 | Webster, Jr. | Sep 2000 | A |
| 6126658 | Baker | Oct 2000 | A |
| 6132447 | Dorsey | Oct 2000 | A |
| 6136010 | Modesitt et al. | Oct 2000 | A |
| 6143024 | Campbell et al. | Nov 2000 | A |
| 6149658 | Gardiner et al. | Nov 2000 | A |
| 6156055 | Ravenscroft | Dec 2000 | A |
| 6159240 | Sparer et al. | Dec 2000 | A |
| 6162233 | Williamson, IV et al. | Dec 2000 | A |
| 6165164 | Hill et al. | Dec 2000 | A |
| 6165183 | Kuehn et al. | Dec 2000 | A |
| 6165204 | Levinson et al. | Dec 2000 | A |
| 6168614 | Andersen et al. | Jan 2001 | B1 |
| 6171320 | Monassevitch | Jan 2001 | B1 |
| 6182664 | Cosgrove | Feb 2001 | B1 |
| 6187003 | Buysse et al. | Feb 2001 | B1 |
| 6190408 | Melvin | Feb 2001 | B1 |
| 6193734 | Bolduc et al. | Feb 2001 | B1 |
| 6200315 | Gaiser et al. | Mar 2001 | B1 |
| 6203531 | Ockuly et al. | Mar 2001 | B1 |
| 6203553 | Robertson et al. | Mar 2001 | B1 |
| 6206893 | Klein et al. | Mar 2001 | B1 |
| 6206907 | Marino et al. | Mar 2001 | B1 |
| 6210337 | Dunham et al. | Apr 2001 | B1 |
| 6210419 | Mayenberger et al. | Apr 2001 | B1 |
| 6210432 | Solem et al. | Apr 2001 | B1 |
| 6217528 | Koblish et al. | Apr 2001 | B1 |
| 6245079 | Nobles et al. | Jun 2001 | B1 |
| 6267746 | Bumbalough | Jul 2001 | B1 |
| 6267781 | Tu | Jul 2001 | B1 |
| 6269819 | Oz et al. | Aug 2001 | B1 |
| 6277555 | Duran et al. | Aug 2001 | B1 |
| 6283127 | Sterman et al. | Sep 2001 | B1 |
| 6283962 | Tu et al. | Sep 2001 | B1 |
| 6290674 | Roue et al. | Sep 2001 | B1 |
| 6299637 | Shaolian et al. | Oct 2001 | B1 |
| 6306133 | Tu et al. | Oct 2001 | B1 |
| 6312447 | Grimes | Nov 2001 | B1 |
| 6319250 | Falwell et al. | Nov 2001 | B1 |
| 6322559 | Daulton et al. | Nov 2001 | B1 |
| 6332880 | Yang et al. | Dec 2001 | B1 |
| 6332893 | Mortier et al. | Dec 2001 | B1 |
| 6346074 | Roth | Feb 2002 | B1 |
| 6352708 | Duran et al. | Mar 2002 | B1 |
| 6355030 | Aldrich et al. | Mar 2002 | B1 |
| 6358277 | Duran | Mar 2002 | B1 |
| 6368326 | Dakin et al. | Apr 2002 | B1 |
| 6387104 | Pugsley, Jr. et al. | May 2002 | B1 |
| 6402780 | Williamson et al. | Jun 2002 | B2 |
| 6402781 | Langberg et al. | Jun 2002 | B1 |
| 6419669 | Frazier et al. | Jul 2002 | B1 |
| 6419696 | Ortiz et al. | Jul 2002 | B1 |
| 6461366 | Seguin | Oct 2002 | B1 |
| 6464707 | Bjerken | Oct 2002 | B1 |
| 6482224 | Michler et al. | Nov 2002 | B1 |
| 6485489 | Teirstein et al. | Nov 2002 | B2 |
| 6406420 | McCarthy | Dec 2002 | B1 |
| 6508828 | Akerfeldt et al. | Jan 2003 | B1 |
| 6533796 | Sauer et al. | Mar 2003 | B1 |
| 6537314 | Langberg et al. | Mar 2003 | B2 |
| 6540755 | Ockuly et al. | Apr 2003 | B2 |
| 6544215 | Bencini et al. | Apr 2003 | B1 |
| 6551303 | Van Tassel et al. | Apr 2003 | B1 |
| 6551331 | Nobles et al. | Apr 2003 | B2 |
| 6562037 | Paton et al. | May 2003 | B2 |
| 6562052 | Nobles et al. | May 2003 | B2 |
| 6575971 | Hauck et al. | Jun 2003 | B2 |
| 6585761 | Taheri | Jul 2003 | B2 |
| 6599311 | Biggs et al. | Jul 2003 | B1 |
| 6616684 | Vidlund et al. | Sep 2003 | B1 |
| 6619291 | Hlavka et al. | Sep 2003 | B2 |
| 6626899 | Houser et al. | Sep 2003 | B2 |
| 6626930 | Allen et al. | Sep 2003 | B1 |
| 6629534 | St. Goar et al. | Oct 2003 | B1 |
| 6641592 | Sauer et al. | Nov 2003 | B1 |
| 6656221 | Taylor et al. | Dec 2003 | B2 |
| 6669687 | Saadat | Dec 2003 | B1 |
| 6685648 | Flaherty et al. | Feb 2004 | B2 |
| 6689164 | Seguin | Feb 2004 | B1 |
| 6695866 | Kuehn et al. | Feb 2004 | B1 |
| 6701929 | Hussein | Mar 2004 | B2 |
| 6702825 | Frazier et al. | Mar 2004 | B2 |
| 6702826 | Liddicoat et al. | Mar 2004 | B2 |
| 6709382 | Homer | Mar 2004 | B1 |
| 6709456 | Langberg et al. | Mar 2004 | B2 |
| 6718985 | Hlavka et al. | Apr 2004 | B2 |
| 6719767 | Kimblad | Apr 2004 | B1 |
| 6723038 | Schroeder et al. | Apr 2004 | B1 |
| 6726716 | Marquez | Apr 2004 | B2 |
| 6740107 | Loeb et al. | May 2004 | B2 |
| 6746471 | Mortier et al. | Jun 2004 | B2 |
| 6752813 | Goldfarb et al. | Jun 2004 | B2 |
| 6755777 | Schweich et al. | Jun 2004 | B2 |
| 6764510 | Vidlund et al. | Jul 2004 | B2 |
| 6767349 | Ouchi | Jul 2004 | B2 |
| 6770083 | Seguin | Aug 2004 | B2 |
| 6797001 | Mathis et al. | Sep 2004 | B2 |
| 6797002 | Spence et al. | Sep 2004 | B2 |
| 6837867 | Kortelling | Jan 2005 | B2 |
| 6855137 | Bon | Feb 2005 | B2 |
| 6860179 | Hopper et al. | Mar 2005 | B2 |
| 6875224 | Grimes | Apr 2005 | B2 |
| 6908481 | Cribier | Jun 2005 | B2 |
| 6926715 | Hauck et al. | Aug 2005 | B1 |
| 6926730 | Nguyen et al. | Aug 2005 | B1 |
| 6945978 | Hyde | Sep 2005 | B1 |
| 6949122 | Adams et al. | Sep 2005 | B2 |
| 6966914 | Abe | Nov 2005 | B2 |
| 6986775 | Morales et al. | Jan 2006 | B2 |
| 7004970 | Cauthen, III et al. | Feb 2006 | B2 |
| 7011669 | Kimblad | Mar 2006 | B2 |
| 7048754 | Martin et al. | May 2006 | B2 |
| 7101395 | Tremulis et al. | Sep 2006 | B2 |
| 7112207 | Allen et al. | Sep 2006 | B2 |
| 7226467 | Lucatero et al. | Jun 2007 | B2 |
| 7288097 | Seguin | Oct 2007 | B2 |
| 7381210 | Zarbatany et al. | Jun 2008 | B2 |
| 7464712 | Oz et al. | Dec 2008 | B2 |
| 7497822 | Kugler et al. | Mar 2009 | B1 |
| 7513908 | Lattouf | Apr 2009 | B2 |
| 7533790 | Knodel et al. | May 2009 | B1 |
| 7563267 | Goldfarb et al. | Jul 2009 | B2 |
| 7563273 | Goldfarb et al. | Jul 2009 | B2 |
| 7569062 | Kuehn et al. | Aug 2009 | B1 |
| 7604646 | Goldfarb et al. | Oct 2009 | B2 |
| 7608091 | Goldfarb et al. | Oct 2009 | B2 |
| 7635329 | Goldfarb et al. | Dec 2009 | B2 |
| 7651502 | Jackson | Jan 2010 | B2 |
| 7655015 | Goldfarb et al. | Feb 2010 | B2 |
| 7655040 | Douk et al. | Feb 2010 | B2 |
| 7666204 | Thornton et al. | Feb 2010 | B2 |
| 7704269 | St. Goar et al. | Apr 2010 | B2 |
| 7798953 | Wilk | Sep 2010 | B1 |
| 7811296 | Goldfarb et al. | Oct 2010 | B2 |
| 7914544 | Nguyen et al. | Mar 2011 | B2 |
| 7972323 | Bencini et al. | Jul 2011 | B1 |
| 7972330 | Alejandro et al. | Jul 2011 | B2 |
| 8029565 | Lattouf | Oct 2011 | B2 |
| 8062313 | Kimblad | Nov 2011 | B2 |
| 8118822 | Schaller et al. | Feb 2012 | B2 |
| 8216256 | Raschdorf, Jr. et al. | Jul 2012 | B2 |
| 8348963 | Wilson et al. | Jan 2013 | B2 |
| 20010004715 | Duran et al. | Jun 2001 | A1 |
| 20010005787 | Oz et al. | Jun 2001 | A1 |
| 20010010005 | Kammerer et al. | Jul 2001 | A1 |
| 20010018611 | Solem et al. | Aug 2001 | A1 |
| 20010022872 | Marui | Sep 2001 | A1 |
| 20010037084 | Nardeo | Nov 2001 | A1 |
| 20010039411 | Johansson et al. | Nov 2001 | A1 |
| 20010044568 | Langberg et al. | Nov 2001 | A1 |
| 20020013571 | Goldfarb et al. | Jan 2002 | A1 |
| 20020022848 | Garrison et al. | Feb 2002 | A1 |
| 20020026233 | Shaknovich | Feb 2002 | A1 |
| 20020035361 | Houser et al. | Mar 2002 | A1 |
| 20020035381 | Bardy et al. | Mar 2002 | A1 |
| 20020042651 | Liddicoat et al. | Apr 2002 | A1 |
| 20020055767 | Forde et al. | May 2002 | A1 |
| 20020055774 | Liddicoat | May 2002 | A1 |
| 20020055775 | Carpentier et al. | May 2002 | A1 |
| 20020058858 | Ogura et al. | May 2002 | A1 |
| 20020058910 | Hermann et al. | May 2002 | A1 |
| 20020058995 | Stevens | May 2002 | A1 |
| 20020077687 | Ahn | Jun 2002 | A1 |
| 20020082621 | Schurr et al. | Jun 2002 | A1 |
| 20020087148 | Brock et al. | Jul 2002 | A1 |
| 20020087169 | Brock et al. | Jul 2002 | A1 |
| 20020087173 | Alferness et al. | Jul 2002 | A1 |
| 20020103532 | Langberg et al. | Aug 2002 | A1 |
| 20020107534 | Schaefer et al. | Aug 2002 | A1 |
| 20020133178 | Muramatsu et al. | Sep 2002 | A1 |
| 20020147456 | Diduch et al. | Oct 2002 | A1 |
| 20020156526 | Hilavka et al. | Oct 2002 | A1 |
| 20020158528 | Tsuzaki et al. | Oct 2002 | A1 |
| 20020161378 | Downing | Oct 2002 | A1 |
| 20020169360 | Taylor et al. | Nov 2002 | A1 |
| 20020183766 | Seguin | Dec 2002 | A1 |
| 20020183787 | Wahr et al. | Dec 2002 | A1 |
| 20020183835 | Taylor et al. | Dec 2002 | A1 |
| 20030005797 | Hopper et al. | Jan 2003 | A1 |
| 20030018358 | Saadat | Jan 2003 | A1 |
| 20030045778 | Ohline et al. | Mar 2003 | A1 |
| 20030050693 | Quijano et al. | Mar 2003 | A1 |
| 20030069570 | Witzel et al. | Apr 2003 | A1 |
| 20030069593 | Tremulis et al. | Apr 2003 | A1 |
| 20030069636 | Solem et al. | Apr 2003 | A1 |
| 20030074012 | Nguyen et al. | Apr 2003 | A1 |
| 20030078654 | Taylor et al. | Apr 2003 | A1 |
| 20030083742 | Spence et al. | May 2003 | A1 |
| 20030105519 | Fasol et al. | Jun 2003 | A1 |
| 20030105520 | Alferness et al. | Jun 2003 | A1 |
| 20030120340 | Lisk et al. | Jun 2003 | A1 |
| 20030120341 | Shennib et al. | Jun 2003 | A1 |
| 20030130669 | Damarati | Jul 2003 | A1 |
| 20030130730 | Cohn et al. | Jul 2003 | A1 |
| 20030144697 | Mathis et al. | Jul 2003 | A1 |
| 20030167071 | Martin et al. | Sep 2003 | A1 |
| 20030171776 | Adams et al. | Sep 2003 | A1 |
| 20030187467 | Schreck | Oct 2003 | A1 |
| 20030195562 | Collier et al. | Oct 2003 | A1 |
| 20030208231 | Williamson, IV et al. | Nov 2003 | A1 |
| 20030225423 | Huitema | Dec 2003 | A1 |
| 20030229395 | Cox | Dec 2003 | A1 |
| 20030233038 | Hassett | Dec 2003 | A1 |
| 20040002719 | Oz et al. | Jan 2004 | A1 |
| 20040003819 | St. Goar et al. | Jan 2004 | A1 |
| 20040019377 | Taylor et al. | Jan 2004 | A1 |
| 20040019378 | Hlavka et al. | Jan 2004 | A1 |
| 20040024414 | Downing | Feb 2004 | A1 |
| 20040030382 | St. Goar et al. | Feb 2004 | A1 |
| 20040034365 | Lentz et al. | Feb 2004 | A1 |
| 20040039442 | St. Goar et al. | Feb 2004 | A1 |
| 20040039443 | Solem et al. | Feb 2004 | A1 |
| 20040044350 | Martin et al. | Mar 2004 | A1 |
| 20040044365 | Bachman | Mar 2004 | A1 |
| 20040049207 | Goldfarb et al. | Mar 2004 | A1 |
| 20040049211 | Tremulis et al. | Mar 2004 | A1 |
| 20040073302 | Rourke et al. | Apr 2004 | A1 |
| 20040078053 | Berg et al. | Apr 2004 | A1 |
| 20040087975 | Lucatero et al. | May 2004 | A1 |
| 20040088047 | Spence et al. | May 2004 | A1 |
| 20040092962 | Thorton et al. | May 2004 | A1 |
| 20040093023 | Allen et al. | May 2004 | A1 |
| 20040097878 | Anderson et al. | May 2004 | A1 |
| 20040097979 | Svanidze et al. | May 2004 | A1 |
| 20040106989 | Wilson et al. | Jun 2004 | A1 |
| 20040111099 | Nguyen et al. | Jun 2004 | A1 |
| 20040122448 | Levine | Jun 2004 | A1 |
| 20040127981 | Randert et al. | Jul 2004 | A1 |
| 20040127982 | Machold et al. | Jul 2004 | A1 |
| 20040127983 | Mortier et al. | Jul 2004 | A1 |
| 20040133062 | Pai et al. | Jul 2004 | A1 |
| 20040133063 | McCarthy et al. | Jul 2004 | A1 |
| 20040133082 | Abraham-Fuchs et al. | Jul 2004 | A1 |
| 20040133192 | Houser et al. | Jul 2004 | A1 |
| 20040133220 | Lashinski et al. | Jul 2004 | A1 |
| 20040133240 | Adams et al. | Jul 2004 | A1 |
| 20040133273 | Cox | Jul 2004 | A1 |
| 20040138744 | Lashinski et al. | Jul 2004 | A1 |
| 20040138745 | Macoviak et al. | Jul 2004 | A1 |
| 20040148021 | Cartledge et al. | Jul 2004 | A1 |
| 20040152847 | Emri et al. | Aug 2004 | A1 |
| 20040152947 | Schroeder et al. | Aug 2004 | A1 |
| 20040153144 | Seguin | Aug 2004 | A1 |
| 20040158123 | Jayaraman | Aug 2004 | A1 |
| 20040162610 | Laiska et al. | Aug 2004 | A1 |
| 20040167539 | Kuehn et al. | Aug 2004 | A1 |
| 20040186486 | Roue et al. | Sep 2004 | A1 |
| 20040186566 | Hindrichs et al. | Sep 2004 | A1 |
| 20040193191 | Starksen et al. | Sep 2004 | A1 |
| 20040215339 | Drasler et al. | Oct 2004 | A1 |
| 20040220593 | Greenhalgh | Nov 2004 | A1 |
| 20040220657 | Nieminen et al. | Nov 2004 | A1 |
| 20040225300 | Goldfarb et al. | Nov 2004 | A1 |
| 20040236354 | Seguin | Nov 2004 | A1 |
| 20040243229 | Vidlund et al. | Dec 2004 | A1 |
| 20040249452 | Adams et al. | Dec 2004 | A1 |
| 20040249453 | Cartledge et al. | Dec 2004 | A1 |
| 20040260393 | Randert et al. | Dec 2004 | A1 |
| 20050004583 | Oz et al. | Jan 2005 | A1 |
| 20050004665 | Aklog | Jan 2005 | A1 |
| 20050004668 | Aklog et al. | Jan 2005 | A1 |
| 20050021056 | St. Goer et al. | Jan 2005 | A1 |
| 20050021057 | St. Goer et al. | Jan 2005 | A1 |
| 20050021058 | Negro | Jan 2005 | A1 |
| 20050033446 | Deem et al. | Feb 2005 | A1 |
| 20050038508 | Gabbay | Feb 2005 | A1 |
| 20050049698 | Bolling et al. | Mar 2005 | A1 |
| 20050055089 | Macoviak et al. | Mar 2005 | A1 |
| 20050059351 | Cauwels et al. | Mar 2005 | A1 |
| 20050149014 | Hauck et al. | Jul 2005 | A1 |
| 20050159810 | Filsoufi | Jul 2005 | A1 |
| 20050197694 | Pai et al. | Sep 2005 | A1 |
| 20050197695 | Stacchino et al. | Sep 2005 | A1 |
| 20050216039 | Lederman | Sep 2005 | A1 |
| 20050228422 | Machold et al. | Oct 2005 | A1 |
| 20050228495 | Macoviak | Oct 2005 | A1 |
| 20050251001 | Hassett | Nov 2005 | A1 |
| 20050267493 | Schreck et al. | Dec 2005 | A1 |
| 20050273160 | Lashinski et al. | Dec 2005 | A1 |
| 20050287493 | Novak et al. | Dec 2005 | A1 |
| 20060004247 | Kute et al. | Jan 2006 | A1 |
| 20060015003 | Moaddes et al. | Jan 2006 | A1 |
| 20060020275 | Goldfarb et al. | Jan 2006 | A1 |
| 20060030866 | Schreck | Feb 2006 | A1 |
| 20060030867 | Zadno | Feb 2006 | A1 |
| 20060030885 | Hyde | Feb 2006 | A1 |
| 20060058871 | Zakay et al. | Mar 2006 | A1 |
| 20060064115 | Allen et al. | Mar 2006 | A1 |
| 20060064116 | Allen et al. | Mar 2006 | A1 |
| 20060064118 | Kimblad | Mar 2006 | A1 |
| 20060089671 | Goldfarb et al. | Apr 2006 | A1 |
| 20060089711 | Dolan | Apr 2006 | A1 |
| 20060135993 | Seguin | Jun 2006 | A1 |
| 20060184203 | Martin et al. | Aug 2006 | A1 |
| 20060190036 | Wendel et al. | Aug 2006 | A1 |
| 20060195012 | Mortier et al. | Aug 2006 | A1 |
| 20060229708 | Powell et al. | Oct 2006 | A1 |
| 20060252984 | Randert et al. | Nov 2006 | A1 |
| 20060293701 | Ainsworth et al. | Dec 2006 | A1 |
| 20070038293 | St. Goar et al. | Feb 2007 | A1 |
| 20070100356 | Lucatero et al. | May 2007 | A1 |
| 20070118155 | Goldfarb et al. | May 2007 | A1 |
| 20070129737 | Goldfarb et al. | Jun 2007 | A1 |
| 20070135826 | Zaver et al. | Jun 2007 | A1 |
| 20070198082 | Kapadia et al. | Aug 2007 | A1 |
| 20070282373 | Ashby et al. | Dec 2007 | A1 |
| 20080039935 | Buch et al. | Feb 2008 | A1 |
| 20080045997 | Balgobin et al. | Feb 2008 | A1 |
| 20080051703 | Thorton et al. | Feb 2008 | A1 |
| 20080051807 | St. Goar et al. | Feb 2008 | A1 |
| 20080097489 | Goldfarb et al. | Apr 2008 | A1 |
| 20080167714 | St. Goer et al. | Jul 2008 | A1 |
| 20080183194 | Goldfarb et al. | Jul 2008 | A1 |
| 20090156995 | Martin et al. | Jun 2009 | A1 |
| 20090163934 | Raschdorf, Jr. et al. | Jun 2009 | A1 |
| 20090177266 | Powell et al. | Jul 2009 | A1 |
| 20090198322 | Deem et al. | Aug 2009 | A1 |
| 20090270858 | Hauck et al. | Oct 2009 | A1 |
| 20090326567 | Goldfarb et al. | Dec 2009 | A1 |
| 20100016958 | St. Goer et al. | Jan 2010 | A1 |
| 20100022823 | Goldfarb et al. | Jan 2010 | A1 |
| 20100324585 | Miles et al. | Dec 2010 | A1 |
| 20130138121 | Allen et al. | May 2013 | A1 |
| 20150223793 | Goldfarb et al. | Aug 2015 | A1 |
| Number | Date | Country |
|---|---|---|
| 2296317 | Jan 2009 | CA |
| 1142351 | Feb 1997 | CN |
| 3504292 | Jul 1986 | DE |
| 19810696 | May 1999 | DE |
| 101 16 168 | Nov 2001 | DE |
| 0 179 562 | Jul 1989 | EP |
| 0 558 031 | Feb 1993 | EP |
| 0 558 031 | Sep 1993 | EP |
| 0 684 012 | Nov 1995 | EP |
| 0 727 239 | Aug 1996 | EP |
| 0 752 235 | Jan 1997 | EP |
| 0 782 836 | Jul 1997 | EP |
| 1 199 037 | Apr 2002 | EP |
| 1 230 899 | Aug 2002 | EP |
| 1383448 | Jan 2004 | EP |
| 1 674 040 | Jun 2006 | EP |
| 2 768 324 | Mar 1999 | FR |
| 2768324 | Mar 1999 | FR |
| 1 598 111 | Sep 1981 | GB |
| 2 151 142 | Jul 1985 | GB |
| 9-192137 | Jul 1997 | JP |
| 09-253030 | Sep 1997 | JP |
| 11-089937 | Apr 1999 | JP |
| 2000-283130 | Oct 2000 | JP |
| 2002-540878 | Dec 2002 | JP |
| 2006-528911 | Dec 2006 | JP |
| 59-85653 | Sep 2016 | JP |
| WO 8100668 | Mar 1981 | WO |
| WO 9101689 | Feb 1991 | WO |
| WO 9118881 | Dec 1991 | WO |
| WO 9212690 | Aug 1992 | WO |
| WO 9418881 | Sep 1994 | WO |
| WO 9418893 | Sep 1994 | WO |
| WO 9511620 | May 1995 | WO |
| WO 9515715 | Jun 1995 | WO |
| WO 9614032 | May 1996 | WO |
| WO 9620655 | Jul 1996 | WO |
| WO 9622735 | Aug 1996 | WO |
| WO 9630072 | Oct 1996 | WO |
| WO 9632882 | Oct 1996 | WO |
| WO 9718746 | May 1997 | WO |
| WO 9725927 | Jul 1997 | WO |
| WO 9726034 | Jul 1997 | WO |
| WO 9727807 | Aug 1997 | WO |
| WO 9738748 | Oct 1997 | WO |
| WO 9739688 | Oct 1997 | WO |
| WO 9748436 | Dec 1997 | WO |
| WO 9807375 | Feb 1998 | WO |
| WO 9824372 | Jun 1998 | WO |
| WO 9830153 | Jul 1998 | WO |
| WO 9832382 | Jul 1998 | WO |
| WO 9835638 | Aug 1998 | WO |
| WO 9900059 | Jan 1999 | WO |
| WO 9901377 | Jan 1999 | WO |
| WO 9907354 | Feb 1999 | WO |
| WO 9913777 | Mar 1999 | WO |
| WO 9915223 | Apr 1999 | WO |
| WO 9966967 | Dec 1999 | WO |
| WO 0002489 | Jan 2000 | WO |
| WO 0003651 | Jan 2000 | WO |
| WO 0003759 | Jan 2000 | WO |
| WO 0012168 | Mar 2000 | WO |
| WO 0044313 | Aug 2000 | WO |
| WO 0059382 | Oct 2000 | WO |
| WO 0060995 | Oct 2000 | WO |
| WO 0100111 | Jan 2001 | WO |
| WO 0100114 | Jan 2001 | WO |
| WO 0103651 | Jan 2001 | WO |
| WO 0126557 | Apr 2001 | WO |
| WO 0126586 | Apr 2001 | WO |
| WO 0126587 | Apr 2001 | WO |
| WO 0126588 | Apr 2001 | WO |
| WO 0126703 | Apr 2001 | WO |
| WO 0128432 | Apr 2001 | WO |
| WO 0128455 | Apr 2001 | WO |
| WO 0135832 | May 2001 | WO |
| WO 0147438 | Jul 2001 | WO |
| WO 0149213 | Jul 2001 | WO |
| WO 0150985 | Jul 2001 | WO |
| WO 0154618 | Aug 2001 | WO |
| WO 0156512 | Aug 2001 | WO |
| WO 0166001 | Sep 2001 | WO |
| WO 0170320 | Sep 2001 | WO |
| WO 0189440 | Nov 2001 | WO |
| WO 0195831 | Dec 2001 | WO |
| WO 0195832 | Dec 2001 | WO |
| WO 0197741 | Dec 2001 | WO |
| WO 0200099 | Jan 2002 | WO |
| WO 0201999 | Jan 2002 | WO |
| WO 0203892 | Jan 2002 | WO |
| WO 0234167 | May 2002 | WO |
| WO 02060352 | Aug 2002 | WO |
| WO 02062263 | Aug 2002 | WO |
| WO 02062270 | Aug 2002 | WO |
| WO 02062408 | Aug 2002 | WO |
| WO 03001893 | Jan 2003 | WO |
| WO 03003930 | Jan 2003 | WO |
| WO 03020179 | Mar 2003 | WO |
| WO 03028558 | Apr 2003 | WO |
| WO 03037171 | May 2003 | WO |
| WO 03047467 | Jun 2003 | WO |
| WO 03049619 | Jun 2003 | WO |
| WO 03073910 | Sep 2003 | WO |
| WO 03073913 | Sep 2003 | WO |
| WO 03082129 | Oct 2003 | WO |
| WO 03105667 | Dec 2003 | WO |
| WO 2004004607 | Jan 2004 | WO |
| WO 2004012583 | Feb 2004 | WO |
| WO 2004012789 | Feb 2004 | WO |
| WO 2004014282 | Feb 2004 | WO |
| WO 2004019811 | Mar 2004 | WO |
| WO 2004030570 | Apr 2004 | WO |
| WO 2004037317 | May 2004 | WO |
| WO 2004045370 | Jun 2004 | WO |
| WO 2004045378 | Jun 2004 | WO |
| WO 2004045463 | Jun 2004 | WO |
| WO 2004047679 | Jun 2004 | WO |
| WO 2004062725 | Jul 2004 | WO |
| WO 2004082523 | Sep 2004 | WO |
| WO 2004082538 | Sep 2004 | WO |
| WO 2004093730 | Nov 2004 | WO |
| WO 04103162 | Dec 2004 | WO |
| WO 2004103162 | Dec 2004 | WO |
| WO 2004112585 | Dec 2004 | WO |
| WO 2004112651 | Dec 2004 | WO |
| WO 2005002424 | Jan 2005 | WO |
| WO 2005018507 | Mar 2005 | WO |
| WO 2005027797 | Mar 2005 | WO |
| WO 2005032421 | Apr 2005 | WO |
| WO 2005062931 | Jul 2005 | WO |
| WO 2005112792 | Dec 2005 | WO |
| WO 2006105008 | Oct 2006 | WO |
| WO 2006105009 | Oct 2006 | WO |
| WO 2006115875 | Nov 2006 | WO |
| WO 2006115876 | Nov 2006 | WO |
| WO 2007106495 | Sep 2007 | WO |
| WO 2008109394 | Sep 2008 | WO |
| WO 2010128502 | Nov 2010 | WO |
| Entry |
|---|
| Abe et al., “De Vega's Annuloplasty for Acquired Tricuspid Disease: Early and Late Results in 110 Patients,” Ann. Thorac. Surg., Jan. 1989, pp. 670-676, vol. 48. |
| Abe et al., “Updated: De Vega's Annuloplasty for Acquired Tricuspid Disease: Early and Late Results in 110 Patients,” Ann. Thorac. Surg. 62:1876-1877 (1996). |
| Agricola et al., “Mitral Valve Reserve in Double Orifice Technique: an Exercise Echocardiographic Study,” Journal of Heart Valve Disease, 11(5):637-643 (2002). |
| Alfieri et al., “An Effective Technique to Correct Anterior Mitral Leaflet Prolapse,” J. Card Surg., 14:468-470 (1999). |
| Alfieri et al., “Novel Suture Device for Beating Heart Mitral Leaflet Approximation,” Annals of Thoracic Surgery, 74:1488-1493 (2002). |
| Alfieri et al., “The double orifice technique in mitral valve repair: a simple solution for complex problems,” Journal of Thoracic and Cardiovascular Surgery, 122:674-681 (2001). |
| Alfieri et al., “The Edge to Edge Technique,” The European Association for Cardio-Thoracic Surgery, 14th Annual Meeting, Frankfurt / Germany, Oct. 7-11, 2000, Post Graduate Courses, Book of Proceedings. |
| Alfieri, “The Edge-to-Edge Repair of the Mitral Valve,” [Abstract] 6th Annual New Era Cardiac Care: Innovation & Technology, Heart Surgery Forum, (Jan. 2003) pp. 103. |
| Alvarez et al., “Repairing the Degenerative Mitral Valve: Ten to Fifteen-year Follow-up,” J. Thorac. Cardiovasc. Surg., Aug. 1996, pp. 238-247, vol. 112. |
| Arisi et al., “Mitral Valve Repair with Alfieri Technique in Mitral Regurgitation of Diverse Etiology: Early Echocardiographic Results,” Circulation Supplement II, 104(17):3240 (2001). |
| Bach et al., “Early Improvement in Congestive Heart Failure After Correction of Secondary Mitral Regurgitation in End-stage Cardiomyopathy,” Am. Heart J., Jun. 1995, pp. 1165-1170, vol. 129. |
| Bach et al., “Improvement Following Correction of Secondary Mitral Regurgitation in End-stage Cardiomyopathy with Mitral Annuloplasty,” Am. J. Cardiol., Oct. 15, 1996, pp. 966-969, vol. 78. |
| Bailey, “Mitral Regurgitation” in Surgery of the Heart, Chapter 20, pp. 686-737 (1955). |
| Bernal et al., “The Valve Racket: a new and different concept of atrioventricular valve repair,” Eur. J. Cardio-thoracic Surgery 29:1026-1029 (2006). |
| Bhudia et al., “Edge-to-Edge (Alfieri) Mitral Repair: Results in Diverse Clinical Settings,” Ann Thorac Surg, 77:1598-1606 (2004). |
| Bhudia et al., “Edge-to-edge Mitral Repair: A Versatile Mitral Repair,” http://www.sts.org/doc/7007 accessed on Sep. 24, 2008. |
| Bolling et al., “Surgery for Acquired Heart Disease: Early Outcome of Mitral Valve Reconstruction in Patients with End-stage Cardiomyopathy,” J. Thor. and Cardiovasc. Surg., Apr. 1995, pp. 676-683, vol. 109. |
| Borghetti et al., “Preliminary observations on haemodynamics during physiological stress conditions following ‘double-orifice’ mitral valve repair,” European Journal of Cardiothoracic Surgery, 20:262-269 (2001). |
| Castedo, “Edge-to-Edge Tricuspid Repair for Redeveloped Valve Incompetence after DeVega's Annuloplasty,” Ann Thora Surg., 75:605-606 (2003). |
| Chinese Office Action dated Sep. 9, 2013 in Application No. 200980158707.2 (with English translation). |
| Communication dated Apr. 16, 2018 from the European Patent Office in counterpart European application No. 04752603.3. |
| Communication dated Apr. 28, 2017 issued by the European Patent Office in counterpart application No. 16196023.2. |
| Communication dated Jan. 26, 2017, from the European Patent Office in counterpart European application No. 16196023.2. |
| Communication dated May 8, 2017, from the European Patent Office in counterpart European Application No. 04752714.8. |
| Derwent citing Japanese language patent, JP 11089937 published Jun 4, 1999, for: “Catheter for mitral regurgitation test—includes jet nozzles provided on rear side of large diametered spindle shaped portion attached to end of narrow diametered tube”. |
| Dottori et al., “Echocardiographic imaging of the Alfieri type mitral valve repair,” Ital. Heart J., 2(4):319-320 (2001). |
| Downing et al., “Beating heart mitral valve surgery: Preliminary model and methodology,” Journal of Thoracic and Cardiovascular Surgery, 123(6):1141-1146 (2002). |
| Extended European Search Report dated Jul. 19, 2018 in EP 18177999.2. |
| Extended European Search Report, dated Oct. 17, 2014, issued in European Patent Application No. 06751584.1. |
| Falk et al., “Computer-Enhanced Mitral Valve Surgery: Toward a Total Endoscopic Procedure,” Seminars in Thoracic and Cardiovascular Surgery, 11(3):244-249 (1999). |
| Filsoufi et al., “Restoring Optimal Surface of Coaptation With a Mini Leaflet Prosthesis: A New Surgical Concept for the Correction of Mitral Valve Prolapse,” Intl. Soc. for Minimally Invasive Cardiothoracic Surgery 1(4):186-87 (2006). |
| Frazier et al., “Early Clinical Experience with an Implantable, Intracardiac Circulatory Support Device: Operative Considerations and Physiologic Implications,” http://www.sts.org/doc/7007 accessed on Sep. 24, 2008. |
| Fucci et al., “Improved Results with Mitral Valve Repair Using New Surgical Techniques,” Eur. J. Cardiothorac. Surg., Nov. 1995, pp. 621-627, vol. 9. |
| Fundaro et al., “Chordal Plication and Free Edge Remodeling for Mitral Anterior Leaflet Prolapse Repair: 8-Year Follow-up,” Annals of Thoracic Surgery, 72:1515-1519 (2001). |
| Garcia-Rinaldi et al., “Left Ventricular Volume Reduction and Reconstruction is Ischemic Cardiomyopathy,” Journal of Cardiac Surgery, 14:199-210 (1999). |
| Gateliene et al., “Early and late postoperative results of mitral and tricuspid valve insufficiency surgical treatment using edge-to-edge central coaptation procedure,” Medicina (Kaunas) 38(Suppl. 2):172-175 (2002). |
| Gatti et al., “The edge to edge technique as a trick to rescue an imperfect mitral valve repair,” Eur. J. Cardiothorac Surg, 22:817-820 (2002). |
| Gillinov et al., “Is Minimally Invasive Heart Valve Surgery a Paradigm for the Future?” Current Cardiology Reports, 1:318-322 (1999). |
| Gundry et al., “Facile Mitral Valve Repair Utilizing Leaflet Edge Approximation: Midterm Results of the Alfieri Figure of Eight Repair,” The Western Thoracic Surgical Association, Scientific Session (May 1999). |
| Gupta et al., “Influence of Older Donor Grafts on Heart Transplant Survival: Lack of Recipient Effects,” http://www.sts.org/doc/7007 accessed on Sep. 24, 2008. |
| Ikeda et al., “Batista's Operation with Coronary Artery Bypass Grafting and Mitral Valve Plasty for Ischemic Dilated Cardiomyopathy,” The Japanese Journal of Thoracic and Cardiovascular Surgery, 48:746-749 (2000). |
| International Search Report and Written Opinion of PCT Application No. PCT/US2009/068023, dated Mar. 2, 2010, 10 pages total. |
| Izzat et al., “Early Experience with Partial Left Ventriculectomy in the Asia-Pacific Region,” Annuals of Thoracic Surgery, 67:1703-1707 (1999). |
| Kallner et al., “Transaortic Approach for the Alfieri Stitch,” Ann Thorac Surg, 71:378-380 (2001). |
| Kameda et al., “Annuloplasty for Severe Mitral Regurgitation Due to Dilated Cardiomyopathy,” Ann. Thorac. Surg., 1996, pp. 1829-1832, vol. 61. |
| Kavarana et al., “Transaortic Repair of Mitral Regurgitation,” The Heart Surgery Forum, #2000-2389, 3(1):24-28 (2000). |
| Kaza et al., “Ventricular Reconstruction Results in Improved Left Ventricular Function and Amelioration of Mitral Insufficiency,” Annals of Surgery, 235(6):828-832 (2002). |
| Khan et al., “Blade Atrial Septostomy: Experience with the First 50 Procedures,” Cathet. Cardiovasc. Diagn., Aug. 1991, pp. 257-262, vol. 23. |
| Kherani et al., “The Edge-To-Edge Mitral Valve Repair: The Columbia Presbyterian Experience,” Ann. Thorac. Surg., 78:73-76 (2004). |
| Konertz et al., “Results After Partial Left Ventriculectomy in a European Heart Failure Population,” Journal of Cardiac Surgery, 14:129-135 (1999). |
| Kron et al., “Surgical Relocation of the Posterior Papillary Muscle in Chronic Ischemic Mitral Regurgitation,” Annals. of Thoracic Surgery, 74:600-601 (2002). |
| Kruger et al., “P73—Edge to Edge Technique in Complex Mitral Valve Repair,” Thorac Cardiovasc Surg., 48(Suppl. 1):106 (2000). |
| Langer et al., “Posterier mitral leaflet extensions: An adjunctive repair option for ischemic mitral regurgitation?” J Thorac Cardiovasc Surg, 131:868-877 (2006). |
| Lorusso et al., “‘Double-Orifice’ Technique to Repair Extensive Mitral Valve Excision Following Acute Endocarditis,” J. Card Surg, 13:24-26 (1998). |
| Lorusso et al., “The double-orifice technique for mitral valve reconstruction: predictors of postoperative outcome,” Eur J. Cardiothorac Surg, 20:583-589 (2001). |
| Maisano et al., “The Double Orifice Repair for Barlow Disease: A Simple Solution for Complex Repair,” Circulation 100(18)1-94 (1999). |
| Maisano et al., “The double orifice technique as a standardized approach to treat mitral regurgitation due to severe myxomatous disease: surgical technique,” European Journal of Cardio-thoracic Surgery, 17:201-205 (2000). |
| Maisano et al., “The Edge-to-edge Technique: A Simplified Method to Correct Mitral Insufficiency,” Eur. J. Cardiothorac. Surg., Jan. 14, 1998, pp. 240-246, vol. 13. |
| Maisano et al., “The hemodynamic effects of double-orifice valve repair for mitral regurgitation: a 3D computational model,” European Journal of Cardio-thoracic Surgery, 15:419-425 (1999). |
| Maisano et al., “Valve repair for traumatic tricuspid regurgitation,” Eur. J. Cardio-thorac Surg, 10:867-873 (1996). |
| Mantovani et al., “Edge-to-edge Repair of Congenital Familiar Tricuspid Regurgitation: Case Report,” J. Heart Valve Dis., 9:641-643 (2000). |
| McCarthy et al., “Partial left ventriculectomy and mitral valve repair for end-stage congestive heart failure,” European Journal of Cardio-thoracic Surgery, 13:337-343 (1998). |
| McCarthy et al., “Tricuspid Valve Repair with the Cosgrove-Edwards Annuloplasty System,” Ann. Thorac. Surg., Jan. 16, 1997, pp. 267-268, vol. 64. |
| Moainie et al., “Correction of Traumatic Tricuspid Regurgitation Using the Double Orifice Technique,” Annals of Thoracic Surgery, 73:963-965 (2002). |
| Morales et al., “Development of an Off Bypass Mitral Valve Repair,” The Heart Surgery Forum #1999-4693, 2(2):115-120 (1999). |
| Nakanishi et al., “Early Outcome with the Alfieri Mitral Valve Repair,” J. Cardiol., 37:263-266 (2001) [Abstract in English; Article in Japanese]. |
| Nielsen et al., “Edge-to-Edge Mitral Repair: Tension of the Approximating Suture and Leaflet Deformation During Acute Ischemic Mitral Regurgitation in the Ovine Heart,” Circulation, 104(Suppl. I):I-29-1-35 (2001). |
| Noera et al., “Tricuspid Valve Incompetence Caused by Nonpenetrating Thoracic Trauma”, Annals of Thoracic Surgery, 51:320-322 (1991). |
| Osawa et al., “Partial Left Ventriculectomy in a 3-Year Old Boy with Dilated Cardiomyopathy,” Japanese Journal of Thoracic and Cardiovascular Surg, 48:590-593 (2000). |
| Park et al., “Clinical Use of Blade Atrial Septostomy,” Circulation, 1978, pp. 600-608, vol. 58. |
| Patel et al., “Epicardial Atrial Defibrillation: Novel Treatment of Postoperative Atrial Fibrillation,” http://www.sts.org/doc/7007 accessed on Sep. 23, 2008. |
| Privitera et al., “Alfieri Mitral Valve Repair: Clinical Outcome and Pathology,” Circulation, 106:e173-e174 (2002). |
| Redaelli et al., “A Computational Study of the Hemodynamics After ‘Edge-To-Edge’ Mitral Valve Repair,” Journal of Biomechanical Engineering, 123:565-570 (2001). |
| Reul et al., “Mitral Valve Reconstruction for Mitral Insufficiency,” Progress in Cardiovascular Diseases, XXXIX(6):567-599 (1997). |
| Ricchi et al., “Linear Segmental Annuloplasty for Mitral Valve Repair,” Ann. Thorac. Surg., Jan. 7, 1997, pp. 1805-1806, vol. 63. |
| Robicsek et al., “The Bicuspid Aortic Valve. How Does It Function? Why Does It Fail,” http://www.sts.org/doc/7007 accessed on Sep. 24, 2008. |
| Supplemental European Search Report of EP Application No. 02746781, dated May 13, 2008, 3 pages total. |
| Supplementary European Search Report issued in European Application No. 05753261.6 dated Jun. 9, 2011, 3 pages total. |
| Tager et al., “Long-Term Follow-Up of Rheumatic Patients Undergoing Left-Sided Valve Replacement with Tricuspid Annuloplasty—Validity of Preoperative Echocardiographic Criteria in the Decision to Perform Tricuspid Annuloplasty,” Am. J. Cardiol., Apr. 15, 1998, pp. 1013-1016, vol. 81. |
| Tamura et al., “Edge to Edge Repair for Mitral Regurgitation in a Patient with Chronic Hemodialysis: Report of a Case,” Kyobu Geka. The Japanese Journal of Thoracic Surgery, 54(9):788-790 (2001). |
| Tibayan et al., “Annular Geometric Remodeling in Chronic Ischemic Mitral Regurgitation,” http://www.sts.org/doc/7007 accessed on Sep. 24, 2008. |
| Timek et al., “Edge-to-edge mitral repair: gradients and three-dimensional annular dynamics in vivo during inotropic stimulation,” Eur J. of Cardiothoracic Surg., 19:431-437 (2001). |
| Timek, “Edge-to-Edge Mitral Valve Repair without Annuloplasty Ring in Acute Ischemic Mitral Regurgitation,” [Abstract] Clinical Science, Abstracts from Scientific Sessions, 106(19):2281 (2002). |
| Totaro, “Mitral valve repair for isolated prolapse of the anterior leaflet: an 11-year follow-up,” European Journal of Cardio-thoracic Surgery, 15:119-126 (1999). |
| Uchida et al., “Percutaneous Cardiomyotomy and Valvulotomy with Angioscopic Guidance,” Am. Heart J., Apr. 1991, pp. 1221-1224, vol. 121. |
| Umana et al., “‘Bow-tie’ Mitral Valve Repair Successfully Addresses Subvalvular Dysfunction in Ischemic Mitral Regurgitation,” Surgical Forum, XLVIII:279-280 (1997). |
| Umana et al., “Bow-Tie Mitral Valve Repair: An Adjuvant Technique for Ischemic Mitral Regurgitation,” Ann. Thorac. Surg., May 12, 1998, pp. 1640-1646, vol. 66. |
| Votta et al., “3-D Computational Analysis of the Stress Distribution on the Leaflets after Edge-to-Edge Repair of Mitral Regurgitation,” Journal of Heart Valve Disease, 11:810-822 (2002). |
| Dec et al., “Idiopathic Dilated Cardiomyopathy,” N. Engl. J. Med., Dec. 8, 1994, pp. 1564-1575, vol. 331. |
| Derwent citing German language patent, EP 684012 published Nov. 12, 1995, for: “Thread for constructing surgical seam—has flexible section with two ends, with lower fastening part on thread first end having hollow cylinder with continuous hole through which surgical needle threads”. |
| Vismara et al., “Transcatheter Edge-to-Edge Treatment of Functional Tricuspid Regurgitation in an Ex Vivo Pulsatile Heart Model,” JACC 68(10):1024-1033 (2016). |
| Petition for Inter Partes Review of Claims 1-9, 12, and 17 of U.S. Pat. No. 7,563,267 filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 101 pages. |
| Exhibit 1001—U.S. Pat. No. 7,563,267 filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 103 pages. |
| Exhibit 1002—Vesely Declaration filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 97 pages. |
| Exhibit 1003—Vesely Curriculum Vitae filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 8 pages. |
| Exhibit 1004—File History of U.S. Pat. No. 7,563,267 (Excerpts) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 616 pages. |
| Exhibit 1005—U.S. Pat. No. 6,165,183 (Kuehn) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 21 pages. |
| Exhibit 1006—U.S. Pat. No. 6,346,074 (Roth) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 64 pages. |
| Exhibit 1007—U.S. Pat. No. 4,340,091 (Skelton) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 12 pages. |
| Exhibit 1008—US 2002-0013571 filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 69 pages. |
| Exhibit 1009—U.S. Appl. No. 60/128,690 Provisional filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 100 pages. |
| Exhibit 1010—Batista, Partial Left Ventriculectomy filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 5 pages. |
| Exhibit 1011—Fucci, Improved Results filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 7 pages. |
| Exhibit 1012—Webster's New World College Dictionary (Excerpts) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 7 pages. |
| Exhibit 1013—Oxford Dictionary (Excerpts) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 10 pages. |
| Exhibit 1014—Random House Dictionary (Excerpts) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 6 pages. |
| Exhibit 1015—Netter, Ciba Collection of Medical Illustrations filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 4 pages. |
| Exhibit 1016—Stone, Clinical Trial Design Principles filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 30 pages. |
| Exhibit 1017—WO 2003-020179 (Tremulis) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 56 pages. |
| Exhibit 1018—U.S. Pat. No. 5,741,297 (Simon) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 11 pages. |
| Exhibit 1019—U.S. Pat. No. 3,874,388 (King) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 20 pages. |
| Exhibit 1020—U.S. Pat. No. 5,716,417 (Girard) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 12 pages. |
| Exhibit 1021—Beall, Clinical Experience filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 9 pages. |
| Exhibit 1022—Complaint (Excerpts) in Abbott v. Edwards, 19-cv-00149 filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 9 pages. |
| Exhibit 1023—Abbott MitraClip IFU (Excerpts) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 1024—Preliminary Injunction Opening Brief (Excerpts) in Abbott v. Edwards, 19-cv-00149 filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 5 pages. |
| Exhibit 1025—Preliminary Injunction Transcript (Excerpts) in Abbott v. Edwards, 19-cv-00149 filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 4 pages. |
| Exhibit 1026—Yoganathan Declaration (Excerpts) in Abbott v. Edwards, 19-cv-00149 filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 9 pages. |
| Exhibit 1027—Keller Letter (Excerpts) in Abbott v. Edwards, 19-cv-00149 filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 1028—Kolata, Tiny Device (NY Times) filed May 29, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 4 pages. |
| Petition for Inter Partes Review of Claims 1-12, 15, 20-31, and 34 of U.S. Pat. No. 8,057,493 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 106 pages. |
| Exhibit 1001—U.S. Pat. No. 8,057,493 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 103 pages. |
| Exhibit 1002—Vesely Declaration filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 111 pages. |
| Exhibit 1003—Vesely Curriculum Vitae filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 8 pages. |
| Exhibit 1004—File History of U.S. Pat. No. 8.057,493 (Excerpts) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 352 pages. |
| Exhibit 1005—U.S. Pat. No. 6,165,183 (Kuehn) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 21 pages. |
| Exhibit 1006—U.S. Pat. No. 6,346,074 (Roth) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 64 pages. |
| Exhibit 1007—U.S. Pat. No. 4,340,091 (Skelton) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 12 pages. |
| Exhibit 1008—US 2002-0013571 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 69 pages. |
| Exhibit 1009—60-128,690 Provisional filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 100 pages. |
| Exhibit 1010—Batista, Partial Left Ventriculectomy filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 5 pages. |
| Exhibit 1011—Fucci, Improved Results filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 7 pages. |
| Exhibit 1012—Webster's New World College Dictionary filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 7 pages. |
| Exhibit 1013—Oxford Dictionary filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 10 pages. |
| Exhibit 1014—Random House Dictionary filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 6 pages. |
| Exhibit 1015—Netter, Ciba Collection of Medical Illustrations filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 4 pages. |
| Exhibit 1016—Stone, Clinical Trial Design Principles filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 30 pages. |
| Exhibit 1017—WO 2003-020179 (Tremulis) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 56 pages. |
| Exhibit 1018—U.S. Pat. No. 5,741,297 (Simon) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 11 pages. |
| Exhibit 1019—U.S. Pat. No. 3,874,388 (King) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 20 pages. |
| Exhibit 1020—U.S. Pat. No. 5,716,417 (Girard) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 12 pages. |
| Exhibit 1021—Beall, Clinical Experience filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 9 pages. |
| Exhibit 1022—Complaint (Excerpts) in Abbott v. Edwards, 19-cv-00149 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 9 pages. |
| Exhibit 1023—MitraClip IFU (Excerpts) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 1024—Preliminary Injunction Opening Brief (Excerpts) in Abbott v. Edwards, 19-cv-00149 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 5 pages. |
| Exhibit 1025—Preliminary Injunction Transcript (Excerpts) in Abbott v. Edwards, 19-cv-00149 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 4 pages. |
| Exhibit 1026—Yoganathan Declaration in Abbott v. Edwards, 19-cv-00149 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 9 pages. |
| Exhibit 1027—Keller Letter (Excerpts) in Abbott v. Edwards, 19-cv-00149 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 1028—Kolata, Tiny Device (NY Times) filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 4 pages. |
| Exhibit 1029—U.S. Pat. No. 7,736,388 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 103 pages. |
| Exhibit 1030—U.S. Pat. No. 7,563,267 filed Jul. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 103 pages. |
| Notice of Opposition dated Apr. 5, 2018 in Opposition of EP1624810, 38 pages. |
| Proprietor Reply to Opposition dated Aug. 25, 2018 in Opposition of EP1624810, 22 pages. |
| Opponent's Further Submissions dated Dec. 24, 2018 in Opposition of EP1624810, 3 pages. |
| EPO Summons to Oral Proceedings dated Mar. 11, 2019 in Opposition of EP1624810, 10 pages. |
| Notice of Intervention dated Mar. 27, 2019 in Opposition of EP1624810, 32 pages. |
| Annex to Notice of Intervention (German Infrigement Complaint) dated Mar. 27, 2019 in Opposition of EP 1624810, 56 pages (submitted in foreign language in full with sections directed to cited art translated to English, wherein this Infrigement Complaint resulted in Edwards Nullity Complaint, which alleges invalidity of the patents-in-suit in this Infrigement Complaint and is submitted in another Information Disclosure Statement filed concurrently herewith). |
| Intervener's Further Submissions dated Apr. 29, 2019 in Opposition of EP1624810, 9 pages. |
| Opponent's Written Submissions dated Jul. 30, 2019 in Opposition of EP1624810, 11 pages. |
| EPO consolidated references listing for EPB1624810 dated Jul. 31, 2019 in Opposition of EP1624810, 1 page. |
| Extended European Search report dated Jul. 24, 2019 in EP Application No. 19171888. |
| POPR dated Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 41 pages. |
| Ex. 2001—USPTO Response for Certificate of Correction filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 2 pages. |
| Ex. 2002—Excerpts of '097 File History filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 2 pages. |
| Ex. 2003—MPEP 200 7th Rev 1 filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 78 pages. |
| Ex. 2004—Parsons Petition Paper 3 filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 85 pages. |
| Ex. 2005—Complaint filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 32 pages. |
| Ex. 2006—Answer and Counterclaims filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 29 pages. |
| Ex. 2007—Amended Answer and Counterclaims filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 39 pages. |
| Ex. 2008—Edwards' Initial Invalidity Contentions filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 249 pages. |
| Ex. 2009—Scheduling Order filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 16 pages. |
| Ex. 2010—WIPO Handbook filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 30 pages. |
| Ex. 2011—U.S. Pat. No. 7,288,097 filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 12 pages. |
| Ex. 2012—MPEP 1800 7th Rev 1 filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 126 pages. |
| Ex. 2013—MPEP 900 3rd Rev 35 filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 27 pages. |
| Ex. 2014—MPEP 900 7th Rev 1 filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 48 pages. |
| Ex. 2015—U.S. Pat. No. 6,463,476 filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 13 pages. |
| Ex. 2016—U.S. Pat. No. 7,643,168 filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 89 pages. |
| Ex. 2017—Request for Certificate of Correction filed Oct. 11, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 31 pages. |
| Petitioners' Motion on Procedural Issues dated Oct. 22, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 16 pages. |
| Exhibit 1021—Excerpts of File History of 097 dated Oct. 22, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 5 pages. |
| U.S. Appl. No. 14/698470 (US 2015/0223793), filed Apr. 28, 2015 (Aug. 13, 2015). |
| U.S. Appl. No. 15/483,523 (US 2017/0239048), filed Apr. 10, 2017 (Aug. 24, 2017). |
| U.S. Appl. No. 16/276,357 (US 2019/0175182), filed Feb. 14, 2019 (Jun. 13, 2019). |
| U.S. Appl. No. 16/406,476, filed May 8, 2019. |
| U.S. Appl. No. 16/406,530, filed May 8, 2019. |
| U.S. Appl. No. 16/408,018, filed May 9, 2019. |
| U.S. Appl. No. 14/698,470, Jun. 7, 2019 Notice of Allowance. |
| U.S. Appl. No. 14/698,470, May 13, 2019 Amendment and Request for Continued Examination (RCE). |
| U.S. Appl. No. 14/698,470, Feb. 15, 2019 Final Office Action. |
| U.S. Appl. No. 14/698,470, Jan. 23, 2019 Response to Non-Final Office Action. |
| U.S. Appl. No. 14/698,470, Oct. 23, 2018 Non-Final Office Action. |
| U.S. Appl. No. 14/698,470, Oct. 5, 2018 Amendment and Request for Continued Examination (RCE). |
| U.S. Appl. No. 14/698,470, Apr. 6, 2018 Final Office Action. |
| U.S. Appl. No. 14/698,470, Feb. 26, 2018 Response to Non-Final Office Action. |
| U.S. Appl. No. 14/698,470, Aug. 31, 2017 Non-Final Office Action. |
| U.S. Appl. No. 14/698,470, Jul. 19, 2017 Response to Restriction Requirement. |
| U.S. Appl. No. 14/698,470, Apr. 20, 2017 Restriction Requirement. |
| U.S. Appl. No. 15/483,523, Mar. 20, 2019 Non-Final Office Action. |
| U.S. Appl. No. 16/406,476, Jun. 20, 2019 Non-Final Office Action. |
| U.S. Appl. No. 16/406,530, Jul. 5, 2019 Non-Final Office Action. |
| U.S. Appl. No. 16/408,018, Aug. 6, 2019 Non-Final Office Action. |
| EP '850 DE nullity—Response English translation, dated Sep. 12, 2019, 48 pages in Abbott Medical GmbH v. Edwards Lifesciences Corporation et al., Ref. No. 4b O 8/19(Germany). |
| EP '850 DE nullity—Response in German, dated Sep. 12, 2019, 50 pages in Abbott Medical GmbH v. Edwards Lifesciences Corporation et al., Ref. No. 4b O 8/19 (Germany). |
| Judgement English translation, dated Aug. 20, 2019, 67 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Judgement, dated Aug. 20, 2019, 68 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Transcript PI Hearing, dated Aug. 20, 2019, 67 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Statement of Claim, dated Oct. 4, 2019, 187 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Amended Grounds of Invalidity, dated Oct. 2, 2019, 3 pages in Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Appeal in civil matters dated Sep. 13, 2019, 48 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Appeal in civil matters Translation dated Sep. 13, 2019, 47 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Supplement to Request of Suspensive Effect dated Sep. 27, 2019, 3 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002. |
| Supplement to Request of Suspensive Effect Translation dated Sep. 27, 2019, 3 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Supplement of Appeal Grounds dated Sep. 20, 2019, 3 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Supplement of Appeal Grounds Translation dated Sep. 20, 2019, 3 pages in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Application to Amend dated Oct. 4, 2019, 3 pages in Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Statement of Grounds dated Oct. 4, 2019, 3 pages in Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Abbott Hearing Slides—Redacted dated Apr. 15, 2019, 189 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Edwards Ltr re 4-22 Abbott Ltr re Claim Construction dated Apr. 22, 2019, 2 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Edwards Ltr re Additional Citations to Patents dated Apr. 22, 2019, 2 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Abbott Ltr re Claim Construction Redacted dated May 3, 2019, 10 pages in Abbott Cardiovascular Systems, Inc. et al. v. dwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Abbott's Objections and Responses to Edwards Second Set of ROGs (Nos. 16-17) (Redacted) dated Aug. 2, 2019, 67 pages in Abbott Ltr re Claim Construction Redacted dated May 3, 2019, 10 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Amended Answer dated Aug. 21, 2019, 39 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Joint Claim Construction Brief dated Sep. 10, 2019, 94 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Amended Joint Claim Construction Chart dated Oct. 16, 2019, 23 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Abbott Markman Demonstratives Redacted dated Oct. 17, 2019, 127 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Edwards Markman Demonstratives dated Oct. 17, 2019, 127 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Markman Memorandum Order dated Oct. 22, 2019, 19 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Petition for Inter Partes Review of Claim 1 of U.S. Pat. No. 6,461,366 filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 76 pages. |
| Exhibit 1001—U.S. Pat. No. 6,461,366 filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 8 pages. |
| Exhibit 1002—Vesely Declaration filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 78 pages. |
| Exhibit 1003—Vesely Curriculum Vitae filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 8 pages. |
| Exhibit 1004—Materials Considered filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 1 page. |
| Exhibit 1005—WO 99-13777 (Publication of PCT-FR98-01960) (with Cover translated to English) filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 26 pages. |
| Exhibit 1006—Certified Copy of French Appl. No. 97-11600 filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 23 pages. |
| Exhibit 1007—U.S. Pat. No. 6,165,183 (Kuehn) filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 21 pages. |
| Exhibit 1008—U.S. Pat. No. 6,629,534 (St. Goar) filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 111 pages. |
| Exhibit 1009—U.S. Appl. No. 60/128,690 (St. Goar Provisional) filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 100 pages. |
| Exhibit 1010—U.S. Pat. No. 6,461,366 File History filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 98 pages. |
| Exhibit 1011—U.S. Pat. No. 5,450,860 (O'Connor) filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 18 pages. |
| Exhibit 1012—U.S. Pat. No. 5,389,077 (Melinyshyn) filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 6 pages. |
| Exhibit 1013—WO 94-18893 (Fitton) filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 27 pages. |
| Exhibit 1014—EP 0558031 A2 (Green) filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 49 pages. |
| Exhibit 1015—Fucci (1995), Improved Results filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 7 pages. |
| Exhibit 1016—Reul (1997), Mitral Valve Reconstruction filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 33 pages. |
| Exhibit 1017—Maisano (1998), The Edge-to-Edge Technique filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 7 pages. |
| Exhibit 1018—Umana (1998), Bow-Tie Mitral Valve Repair filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 6 pages. |
| Exhibit 1019—U.S. Pat. No. 6,770,083 (083 Patent) filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 9 pages. |
| Exhibit 1020—Misc Communication re U.S. Pat. No. 7,288,097 filed Jun. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 26 pages. |
| Petition for Inter Partes Review of Claims 1-2 of U.S. Pat. No. 7,288,097 dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 107 pages. |
| Exhibit 1001—U.S. Pat. No. 7,288,097 dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 11 pages. |
| Exhibit 1002—Vesely Declaration dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 106 pages. |
| Exhibit 1003—Vesely Curriculum Vitae dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 8 pages. |
| Exhibit 1004—Materials Considered dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 1 page. |
| Exhibit 1005—Certified French App. No. 97-11600 dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 23 pages. |
| Exhibit 1006—WO 99-13777 (with Cover translated to English) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 26 pages. |
| Exhibit 1007—U.S. Pat. No. 6,461,366 dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 8 pages. |
| Exhibit 1008—File History of U.S. Pat. No. 6,461,366 dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 98 pages. |
| Exhibit 1009—U.S. Pat. No. 6,770,083 dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 9 pages. |
| Exhibit 1010—File History of U.S. Pat. No. 6,770,083 dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 80 pages. |
| Exhibit 1011—Misc Communication re U.S. Pat. No. 7,288,097 dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 26 pages. |
| Exhibit 1012—U.S. Pat. No. 6,165,183 (Kuehn) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 21 pages. |
| Exhibit 1013—U.S. Pat. No. 3,874,388 (King) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 20 pages. |
| Exhibit 1014—U.S. Pat. No. 5,478,353 (Yoon) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 15 pages. |
| Exhibit 1016—File History of U.S. Pat. No. 7,188,097 (Excerpts) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 372 pages. |
| Exhibit 1017—U.S. Pat. No. 6,269,819 (Oz) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 22 pages. |
| Exhibit 1018—U.S. Pat. No. 5,695,504 (Gifford) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 108 pages. |
| Exhibit 1019—U.S. Pat. No. 5,389,077 (Melinyshyn) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 6 pages. |
| Exhibit 1020—WO 94-18893 (Fitton) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 27 pages. |
| Exhibit 1021—EP 0558031 A2 (Green) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 49 pages. |
| Exhibit 1022—Fucci (1995), Improved Results dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 7 pages. |
| Exhibit 1023—Reul (1997), Mitral Valve Reconstruction dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 33 pages. |
| Exhibit 1024—Maisano (1998), the Edge-to-Edge Technique dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 7 pages. |
| Exhibit 1025—Umana (1998), Bow-Tie Mitral Valve Repair dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 6 pages. |
| Exhibit 1026—U.S. Pat. No. 5,411,552 (Andersen) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 26 pages. |
| Exhibit 1027—Opinion re PI dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 61 pages. |
| Exhibit 1028—Order re TRO dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 5 pages. |
| Exhibit 1029—Revised List of Asserted Claims dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 1 page. |
| Exhibit 1030—Scheduling Order (Excerpt) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 4 pages. |
| Exhibit 1031—Complaint (Excerpt) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 9 pages. |
| Exhibit 1032—MitraClip IFU (Excerpt) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 3 pages. |
| Exhibit 1033—PI Opening Brief (Excerpt) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 5 pages. |
| Exhibit 1034—PI Transcript (Excerpt) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 4 pages. |
| Exhibit 1035—Kolata, Tiny Device (NY Times Article) dated Aug. 8, 2019 from Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 4 pages. |
| Notice of Opposition dated Jan. 11, 2019 in Opposition of EP2755573, 60 pages. |
| Proprietor's Reply to Opposition dated Jul. 22, 2019 in Opposition of EP2755573, 21 pages. |
| U.S. Appl. No. 60/051,078, filed Jun. 27, 1997, Oz, et al. |
| Alfieri, O., et al., “Novel Suture Device for Beating-Heart Mitral Leaflet Approximation,” Ann Thorac Surg 74:1488-93 (2002). |
| Alfieri, O., et al., “The Double-orifice Technique in Mitral Valve Repair: A Simple Solution for Complex Problems,” Journal of Thoracic and Cardiovascular Surgery 122(4):674-681 (2001). |
| Cribier, A., et al., “Percutaneous Mitral Valvotomy with a Metal Dilatator,” The Lancet 349:1667 (1997). |
| Feldman, T., et al., “Technique of Percutaneous Transvenous Mitral Commissurotomy Using the Inoue Balloon Catheter,” Catheterization and Cardiovascular Diagnosis Supplement 2:26-34 (1994). |
| Glazier, J. and Turi, Z., “Percutaneous Balloon Mitral Valvuloplasty,” Progress in Cardiovascular Diseases 40(1):5-26 (1997). |
| Hung et al., “Atrial Septal Puncture Technique in Percutaneous Transvenous Mitral Commissurotomy : Mitral Valvuloplasty Using the Inoue Balloon Catheter Technique,” Catheterization and Cardiovascular Diagnosis 26: 275-284 (1992). |
| Hung et al., “Pitfalls and Tips in Inoue Balloon Mitral Commissurotomy,” Catheterization and Cardiovascular Diagnosis, 37:188-199 (1996). |
| Inoue, K. and Feldman, T., “Percutaneous Transvenous Mitral Commissurotomy Using the Inoue Balloon Catheter,” Catheterization and Cardiovascular Diagnosis 28:119-125 (1993). |
| Inoue, K., et al., “Clinical Application of Transvenous Mitral Commissurotomy by a New Balloon Catheter,” J Thorac Cardiovasc Surg 87:394-402 (1984). |
| Lau, K. and Hung, J., “‘Balloon Impasse’; A Marker for Severe Mitral Subvalvular Disease and a Predictor of Mitral Regurgitation in Inoue-Balloon Percutaneous Transvenous Mitral Commissurotomy,” Catheterization and Cardiovascular Diagnosis 35:310-319 (1995). |
| Lock et al., “Transcatheter Closure of Atrial Septal Defects: Experimental Studies,” Circulation 79:1091-1099 (1989). |
| McCarthy, P., et al., “Early Results with Partial Left Ventriculectomy,” J Thorac Cardiovasc Surg 114(5):755-765 (1997). |
| Morales et al., “Development of an Off Bypass Mitral Valve Repair,” The Heart Surgery Forum, 2(2):115-120 (1999). |
| O'Rourke, R. and Crawford, M., “Mitral Valve Regurgitation,” Year Book Medical Publishers, Inc. 1-52 (1984). |
| Otto, Catherine M., “Timing of Surgery in Mitral Regurgitation,” Heart 89:100-105 (2003). |
| Werker, P. and Kon M., “Review of Facilitated Approaches to Vascular Anastomosis Surgery,” Ann Thorac Surg 63:122-7 (1997). |
| Complaint dated Jan. 28, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 32 pages. |
| Plaintiffs' Opening PI Brief dated Jan. 29, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 30 pages. |
| Declaration and Expert Report of Yoganathan dated Jan. 24, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 452 pages. |
| Plaintiffs' Brief in Support of TRO dated Feb. 18, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 27 pages. |
| Answer and Counterclaims dated Feb. 19, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 29 pages. |
| Edwards' Answering Brief in Opposition of TRO dated Feb. 25, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 32 pages. |
| Plaintiffs' Reply Brief in Support of TRO dated Feb. 26, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 22 pages. |
| Memorandum Order re TRO dated Mar. 5, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 5 pages. |
| First Amended Complaint dated Mar. 8, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 32 pages. |
| Answer and Counterclaims to the First Amended Complaint dated Mar. 22, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 30 pages. |
| Edwards' Answering Brief in Opposition to PI dated Apr. 5, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 32 pages. |
| Declaration of Jensen dated Apr. 5, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 184 pages. |
| Exhibits to Declaration of Jensen dated Apr. 5, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 33 pages. |
| Reply to Counterclaims dated Apr. 12, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 9 pages. |
| Plaintiffs' Reply PI Brief dated Apr. 16, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 22 pages. |
| Reply Declaration and Expert Report of Yoganathan dated Apr. 16, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 156 pages. |
| Memorandum Opinion re PI dated Jun. 6, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 61 pages. |
| Edwards' Initial Invalidity Contentions dated Jul. 3, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 249 pages. |
| Joint Claim Construction Chart dated Jul. 23, 2019 in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware), 26 pages. |
| Request for a Preliminary Injunction dated Jan. 28, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Response to the Request for a Preliminary Injunction dated Mar. 5, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Entry of New Evidence dated Mar. 15, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Declaration of Professor Stephen Brecker dated Mar. 29, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Reply Regarding the Objection of Invalidity dated Apr. 2, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Response to Abbott's Submission dated Apr. 16, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Technical Opinion dated May 20, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Hearing slides for Evalve dated Jul. 3, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Hearing slides re EP 810 non-infringement dated Jul. 3, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Hearing slides re Oral Pleadings of the Defendants dated Jul. 3, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Hearing slides re Invalidity of EP 1 408 850 dated Jul. 5, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences SA et al., Docket No. S2019_002 (Switzerland). |
| Claim Form dated Jan. 28, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Particulars of Claim dated Jan. 28, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Particulars of Infringement dated Jan. 28, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Grounds of Invalidity dated Mar. 13, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Reply and Defence to Counterclaim dated Apr. 3, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Amended Defence and Counterclaim dated Jul. 25, 2019 from Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Infringement Complaint dated Jan. 28, 2019 from Abbott Medical GmbH v. Edwards Lifesciences Corporation et al., Ref. No. 4b O 8/19 (Germany) (submitted in foreign language in full with sections directed to cited art translated to English, wherein this Infringement Complaint resulted in Edwards Nullity Complaint, which alleges invalidity of the patents-in-suit in this Infringement Complaint and is submitted concurrently herewith). |
| Edwards Nullity Complaint dated Mar. 15, 2019 from Abbott Medical GmbH v. Edwards Lifesciences Corporation et al., Ref. No. 4b O 8/19 (Germany) (with translation to English). |
| PI Application dated Jan. 28, 2019 from Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., Docket No. 4251/2019/CC (Italy) (submitted in foreign language in full, wherein this document requests a Preliminary Injunction that resulted in Edwards Statement of Defense, which asserts invalidity of the patent-in-suit and is submitted concurrently herewith). |
| Burriesci Declaration dated Jan. 22, 2019 from Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., Docket No. 4251/2019/CC (Italy) (submitted in foreign language in full, wherein this document supports the request for a Preliminary Injunction that resulted in Edwards Statement of Defense, which asserts invalidity of the patent-in-suit and is submitted concurrently herewith). |
| Statement of Defense dated Apr. 10, 2019 from Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., Docket No. 4251/2019/CC (Italy) (with translation to English). |
| Technical Opinion dated Apr. 10, 2019 from Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., Docket No. 4251/2019/CC (Italy) (with translation to English). |
| Authorized Brief dated May 2, 2019 from Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., Docket No. 4251/2019/CC (Italy) (with translation to English). |
| Authorized Brief dated May 13, 2019 from Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., Docket No. 4251/2019/CC (Italy) (with translation to English). |
| U.S. Appl. No. 60/128,690, filed Apr. 9, 1999, Deem et al. |
| Arthur C. Beall et al., Clinical Experience with a Dacron Velour-Covered Teflon-Disc Mitral Valve Prosthesis, 5 Ann. Thorac. Surg. 402-10 (1968). |
| C. Fucci et al., Improved Results with Mitral Valve Repair Using New Surgical Techniques, 9 Eur. J. Cardiothorac. Surg. 621-27 (1995). |
| F. Maisano et al., The Edge-to-Edge Technique: A Simplified Method to Correct Mitral Insufficiency, 13 J. Cardio-thoracic Surgery 240-46 (1998). |
| Gregg W. Stone et al., Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document from the Mitral Valve Academic Research Consortium, 66 J. Am. Coll. Cardiol. 278-307 (2015). |
| Juan P. Umaña et al., “Bow-Tie” Mitral Valve Repair: An Adjuvant Technique for Ischemic Mitral Regurgitation, 66 Annals of Thoracic Surgery 1640-46 (1998). |
| Netter, F. H., et al., “The Ciba Collection of Medical Illustrations,” vol. 5. Royal Victorian Institute for the Blind Tertiary Resource Service, Melbourne (1969). |
| Randas J. V. Batista et al., Partial Left Ventriculectomy to Treat End-Stage Heart Disease, 64 Ann. Thorac. Surg. 634-38 (1997). |
| Ross M. Reul et al., Mitral Valve Reconstruction for Mitral Insufficiency, 39 Progress in Cardiovascular Diseases 567-99 (1997). |
| Patent Owner Preliminary Response POPR, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 87 pages. |
| Exhibit 2001—Christopher Quinn Declaration, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 59 pages. |
| Exhibit 2002—Christopher Quinn CV, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 2003—Dr. Joshua Rovin Declaration, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 51 pages. |
| Exhibit 2004—Dr. Joshua Rovin CV, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 10 pages. |
| Exhibit 2005—U.S. Pat. No. 5,823,956 to Roth, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 54 pages. |
| Exhibit 2006—FDA Letter, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 16 pages. |
| Exhibit 2007—NYTimes Article, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 5 pages. |
| Exhibit 2008—Yoganathan Report, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 449 pages. |
| Exhibit 2009—Complaint, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 32 pages. |
| Exhibit 2010—Answer and Counterclaims, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 29 pages. |
| Exhibit 2011—Scheduling Order, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 16 pages. |
| Exhibit 2012—COAPT MitraClip, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 9 pages. |
| Exhibit 2013—Demonstrative re Petition same as Litigation, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 8 pages. |
| Exhibit 2014—Amended Answer and Counterclaims, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 39 pages. |
| Exhibit 2015—Edwards' Initial Invalidity Contentions, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 249 pages. |
| Exhibit 2016—US20040167539 to Kuehn, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 21 pages. |
| Exhibit 2017—U.S. Pat. No. 6,695,866 to Kuehn, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 21 pages. |
| Exhibit 2018—U.S. Pat. No. 6,346,074 to Roth, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 64 pages. |
| Exhibit 2019—U.S. Pat. No. 5,823,956 to Roth, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 54 pages. |
| Exhibit 2020—U.S. Pat. No. 5,855,614 to Stevens and Roth, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 55 pages. |
| Exhibit 2021—Perlowski Pt1, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 100 pages. |
| Exhibit 2021—Perlowski Pt2, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 98 pages. |
| Exhibit 2022—Transcatheter Mitral Valve Repair with MitraClip, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 20 pages. |
| Exhibit 2023—Feldman 2005, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 7 pages. |
| Exhibit 2024—Excerpts Oxford Dictionary, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 2025—Excerpts Webster's New World Dictionary, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 4 pages. |
| Exhibit 2026—Excerpts Webster's Dictionary of American English, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 2027—Excerpts Illustrated Oxford Dictionary, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 2028—U.S. Appl. No. 10/383,596 File History, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 196 pages. |
| Exhibit 2029—Maisano, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 10 pages. |
| Exhibit 2030—Alfieri, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 8 pages. |
| Exhibit 2031—MitraClip Instructions for Use, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 54 pages. |
| Exhibit 2032—Transcript Feldman re Everest, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 2033—Joint Claim Construction Chart, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 26 pages. |
| Exhibit 2034—Edwards Analyst Investor Day, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 49 pages. |
| Exhibit 2035—Mack, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 2036—Rogoski, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 2037—Piazza, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 15 pages. |
| Exhibit 2040—Kheradvar, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 11 pages. |
| Exhibit 2041—FDA re MitraClip, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 2042—Gossl, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 8 pages. |
| Exhibit 2043—Business Monitor Online, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 2 pages. |
| Exhibit 2044—Excerpts MitraClip Physician Site, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 6 pages. |
| Exhibit 2045—Feldman 2009, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 9 pages. |
| Exhibit 2046—LexMachina Case Timing for Delaware, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 1 page. |
| Exhibit 2047—Wood TCT 2018, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 5 pages. |
| Exhibit 2048—Excerpts MitraClip FAQ Physician, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 4 pages. |
| Exhibit 2049—U.S. Pat. No. 8,172,856 to Eigler, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 26 pages. |
| Exhibit 2050—U.S. Pat. No. 9,76,3658 to Eigler, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 27 pages. |
| Exhibit 2052—Belden Technologies Inc v Superior Essex Communications LP, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 3 pages. |
| Exhibit 2053—Wood TCTMD, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 11 pages. |
| Exhibit 2054—D. Del. Docket Sheet, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 27 pages. |
| Exhibit 2055—Letter re Markman Hearing, filed Sep. 5, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 2 pages. |
| Edwards Petition for Inter Partes Review of '388 Patent, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 105 pages. |
| Exhibit 1001—U.S. Pat. No. 7,736,388, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 103 pages. |
| Exhibit 1002—Vesely Declaration, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 101 pages. |
| Exhibit 1003—Vesely Curriculum Vitae, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 8 pages. |
| Exhibit 1004—File History of U.S. Pat. No. 7,736,388 (Excerpts), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 353 pages. |
| Exhibit 1005—U.S. Pat. No. 6,165,183 (Kuehn), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 21 pages. |
| Exhibit 1006—U.S. Pat. No. 6,346,074 (Roth), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 64 pages. |
| Exhibit 1007—U.S. Pat. No. 4,340,091 (Skelton), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 12 pages. |
| Exhibit 1008—US 2002-0013571 (Goldfarb), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 69 pages. |
| Exhibit 1009—U.S. Appl. No. 60/128,690, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 100 pages. |
| Exhibit 1010—Batista, Partial Left Ventriculectomy, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 5 pages. |
| Exhibit 1011—Fucci, Improved Results, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 7 pages. |
| Exhibit 1012—Webster's New World College Dictionary (Excerpt), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 7 pages. |
| Exhibit 1013—Oxford Dictionary (Excerpt), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 10 pages. |
| Exhibit 1014—Random House Dictionary (Excerpt), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 6 pages. |
| Exhibit 1015—Netter, Ciba Collection of Medical Illustrations (Excerpt), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 4 pages. |
| Exhibit 1017—WO 2003-020179 (Tremulis), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 56 pages. |
| Exhibit 1018—U.S. Pat. No. 5,741,297 (Simon), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 11 pages. |
| Exhibit 1019—U.S. Pat. No. 3,874,388 (King), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 20 pages. |
| Exhibit 1020—U.S. Pat. No. 5,716,417 (Girard), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 12 pages. |
| Exhibit 1021—Beall, Clinical Experience, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 9 pages. |
| Exhibit 1022—Complaint (Excerpt) in Abbott v. Edwards, 19-cv-00149, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 9 pages. |
| Exhibit 1023—MitraClip IFU (Excerpt), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 1024—PI Opening Brief (Excerpt) in Abbott v. Edwards, 19-cv-00149, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 5 pages. |
| Exhibit 1025—PI Transcript (Excerpt) in Abbott v. Edwards, 19-cv-00149, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 4 pages. |
| Exhibit 1026—Yoganathan Declaration (Excerpt) in Abbott v. Edwards, 19-cv-00149, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 9 pages. |
| Exhibit 1027—Keller Letter (Excerpt) in Abbott v. Edwards, 19-cv-00149, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 1028—Kolata, Tiny Device (NY Times), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 4 pages. |
| Exhibit 1030—U.S. Pat. No. 7,563,267, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 103 pages. |
| Exhibit 1032—Opinion (Excerpts), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 6 pages. |
| Exhibit 1033—Abbott Claim Construction Email, filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 2 pages. |
| Exhibit 1034—Joint Claim Construction Chart (Excerpts), filed Aug. 23, 2019, in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Final Written Submissions of Evalve dated Sep. 4, 2019 in Opposition of EP1624810, 39 pages. |
| Written Submissions from Edwards dated Sep. 4, 2019 in Opposition of EP1624810, 9 pages. |
| Written Submissions from Edwards dated Sep. 18, 2019 in Opposition of EP1624810, 29 pages. |
| Final POPR dated Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 90 pages. |
| Exhibit 2001—Quinn Declaration filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 63 pages. |
| Exhibit 2002—Quinn CV filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 2003—Rovin Decl. 493 Patent filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 57 pages. |
| Exhibit 2004—Rovin CV filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 10 pages. |
| Exhibit 2005—U.S. Pat. No. 5,823,956 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 54 pages. |
| Exhibit 2006—FDA Letter filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 16 pages. |
| Exhibit 2007—NYTimes Article filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 5 pages. |
| Exhibit 2008—Yoganathan Report filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 449 pages. |
| Exhibit 2009—Complaint filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 32 pages. |
| Exhibit 2010—Answer and Counterclaims filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 29 pages. |
| Exhibit 2011—Scheduling Order filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 16 pages. |
| Exhibit 2012—COAPT MitraClip filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 9 pages. |
| Exhibit 2013 Demonstrative Comparing POPR to Invalidity Contentions filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 8 pages. |
| Exhibit 2014—Amended Answer and Counterclaims filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 39 pages. |
| Exhibit 2015—Edwards' Initial Invalidity Contentions filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 249 pages. |
| Exhibit 2016—US 20040167539 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 21 pages. |
| Exhibit 2017—U.S. Pat. No. 6,695,866 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 21 pages. |
| Exhibit 2018—U.S. Pat. No. 6,346,074 (Roth) Highlighted filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 64 pages. |
| Exhibit 2019—U.S. Pat. No. 5,823,956 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 54 pages. |
| Exhibit 2021—Perlowski Pt1 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 100 pages. |
| Exhibit 2021—Perlowski Pt2 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 98 pages. |
| Exhibit 2022—Transcather Mitral Valve Repair with MitraClip filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 20 pages. |
| Exhibit 2023—Feldman 2005 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 7 pages. |
| Exhibit 2024—Excerpts Oxford Dictionary filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 2025—Excerpts Webster's New World Dictionary filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 4 pages. |
| Exhibit 2026—Excerpts Webster's Dictionary of American English filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 2027—Excerpts Illustrated Oxford Dictionary filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 2028—U.S. Pat. No. 10,383,596 File History filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 196 pages. |
| Exhibit 2029—Maisano filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 10 pages. |
| Exhibit 2030—Alfieri filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 8 pages. |
| Exhibit 2031—MitraClip Instructions for Use filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 54 pages. |
| Exhibit 2032—Transcript Feldman re Everest filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 2034—Edwards Analyst Investor Day filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 49 pages. |
| Exhibit 2035—Mack filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 2036—Rogoski filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 2037—Piazza filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 15 pages. |
| Exhibit 2040—Kheradvar filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 11 pages. |
| Exhibit 2041—FDA re MitraClip filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 2042—Gossl filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 8 pages. |
| Exhibit 2043—Business Monitor Online filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 2 pages. |
| Exhibit 2044—Excerpts MitraClip Physician Site filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 6 pages. |
| Exhibit 2045—Feldman 2009 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 9 pages. |
| Exhibit 2046—LexMachina Case Timing for Delaware filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 1 page. |
| Exhibit 2047—Wood TCT 2018 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 5 pages. |
| Exhibit 2048—Excerpts MitraClip FAQ Physician filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 4 pages. |
| Exhibit 2049—U.S. Pat. No. 8,172,856 to Eigler filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 26 pages. |
| Exhibit 2050—U.S. Pat. No. 9,763,658 to Eigler filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 27 pages. |
| Exhibit 2052—Belden Technologies Inc v Superior Essex Communications LP filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 3 pages. |
| Exhibit 2053—Wood TCTMD filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 11 pages. |
| Exhibit 2054—Docket Oct. 10, 2019 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 40 pages. |
| Exhibit 2056—WO0003759A2 to Kuehn filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 47 pages. |
| Exhibit 2057—U.S. Pat. No. 6,773,440B2 filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 38 pages. |
| Exhibit 2058—Joint Claim Construction Brief filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 94 pages. |
| Exhibit 2059—Email from B Lasky filed Oct. 18, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 1 page. |
| Petitioners' Authorized Reply dated Oct. 14, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 8 pages. |
| PO Sur Reply dated Oct. 21, 2019 in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 11 pages. |
| Patent Owner Briefing Re Claim Construction, filed Nov. 26, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 14 pages. |
| Petitioner's Response Re Claim Construction, filed Dec. 2, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 8 pages. |
| Decision Denying Institution, filed Dec. 4, 2019, in Inter Partes Review of U.S. Pat. No. 7,563,267, Case No. IPR2019-01132, 34 pages. |
| Patent Owner Briefing Re Claim Construction, filed Nov. 26, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 14 pages. |
| Petitioner's Response Re Claim Construction, filed Dec. 2, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 8 pages. |
| Petitioner's Reply to POPR, filed Dec. 3, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 10 pages. |
| Patent Owner Surreply, filed Dec. 12, 2019 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 12 pages. |
| EP810 Amended Specification, filed Jan. 3, 2020 in Opposition of EP1624810, 107 pages. |
| EP810 Decision, filed Jan. 3, 2020 in Opposition of EP1624810, 37 pages. |
| EP810 Minutes filed Jan. 3, 2020 in Opposition of EP1624810, 23 pages. |
| '388 POPR, filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 90 pages. |
| Exhibit 2001—Dr. Quinn Declaration filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 71 pages. |
| Exhibit 2002—Quinn CV filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 2003—Dr. Rovin Declaration filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 51 pages. |
| Exhibit 2004—Rovin CV filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 10 pages. |
| Exhibit 2005—U.S. Pat. No. 5823956 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 54 pages. |
| Exhibit 2006—FDA Letter filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 16 pages. |
| Exhibit 2007—NY Times Article filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 5 pages. |
| Exhibit 2008—Yoganathan Report filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 449 pages. |
| Exhibit 2009 — Complaint filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 32 pages. |
| Exhibit 2011—Scheduling Order filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 16 pages. |
| Exhibit 2012—COAPT MitraClip filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 9 pages. |
| Exhibit 2013—Demonstrative re copied arguments filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 5 pages. |
| Exhibit 2016—US20040167539 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 21 pages. |
| Exhibit 2017—U.S. Pat. No.6695866 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 21 pages. |
| Exhibit 2018—U.S. Pat. No. 6346074 (Roth) Highlighted filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 64 pages. |
| Exhibit 2019—Roth '956 Highlighted filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 54 pages. |
| Exhibit 2020—U.S. Pat. No.5855614 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 55 pages. |
| Exhibit 2021 — Perlowski Part 1 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case no. IPR2019-01546, 100 pages. |
| Exhibit 2021 — Perlowski Part 2 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case no. IPR2019-01546, 98 pages. |
| Exhibit 2022—Transcather Mitral Valve Repair with MitraClip filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 20 pages. |
| Exhibit 2023—Feldman 2005 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 7 pages. |
| Exhibit 2024—Excerpts Oxford Dictionary filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 2025—Webster's New World Dictionary filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 4 pages. |
| Exhibit 2026—Excerpts Webster's Dictionary of American English filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 2027—Excerpts Illustrated Oxford Dictionary filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 2029 — Maisano filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 10 pages. |
| Exhibit 2030 — Alfieri filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 8 pages. |
| Exhibit 2031—MitraClip IFU filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 54 pages. |
| Exhibit 2032—Transcript Feldman re Everest filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 2034—Edwards Analyst Investor Day filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 49 pages. |
| Exhibit 2035 — Mack filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 2036 — Rogoski filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 2037 — Piazza filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 15 pages. |
| Exhibit 2040 — Kheradvar filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 11 pages. |
| Exhibit 2041—FDA re MitraClip filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 2042 — Gossl filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 8 pages. |
| Exhibit 2043—Business Monitor Online filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 2 pages. |
| Exhibit 2044—Excerpts MitraClip Physician Site filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 6 pages. |
| Exhibit 2045—Feldman 2009 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 9 pages. |
| Exhibit 2046—LexMachina Case Timing for Delaware filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 1 page. |
| Exhibit 2047—Wood TCT 2018 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 5 pages. |
| Exhibit 2048—Excerpts MitraClip FAQ Physician filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 4 pages. |
| Exhibit 2049—U.S. Pat. No. 8172856 to Eigler filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 26 pages. |
| Exhibit 2050—U.S. Pat. No.9763658 to Eigler filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 27 pages. |
| Exhibit 2052—Belden Technologies Inc v Superior Essex Communications LP filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 3 pages. |
| Exhibit 2053—Wood TCTMD filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 11 pages. |
| Exhibit 2054—Docket Nov. 21, 2019 filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 44 pages. |
| Exhibit 2056—WO0003759A2 to Kuehn filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 47 pages. |
| Exhibit 2061—Markman Order filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 19 pages. |
| Exhibit 2062—Claim Construction Stipulation filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 2 pages. |
| Exhibit 2063—Edwards Final Invalidity Contentions filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 262 pages. |
| Exhibit 2066—Tremulis filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 37 pages. |
| Exhibit 2067 — Decision Denying Institution filed Dec. 23, 2019 in Inter Partes Review of U.S. Pat. No. 7,736,388; Case No. IPR2019-01546, 34 pages. |
| Patent Owner Preliminary Response filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 86 pages. |
| Exhibit 2001—Quinn Declaration filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 52 pages. |
| Exhibit 2002—Quinn CV filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 3 pages. |
| Exhibit 2003—Rovin Declaration filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 42 pages. |
| Exhibit 2004—Rovin CV filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 10 pages. |
| Exhibit 2005—U.S. Pat. No. 5,823,956 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 54 pages. |
| Exhibit 2006—FDA Letter filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 16 pages. |
| Exhibit 2007 — NY Times Article filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case no. IPR2019-01479, 5 pages. |
| Exhibit 2008—Yoganathan Report filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 449 pages. |
| Exhibit 2009 — Complaint filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 32 pages. |
| Exhibit 2011—Scheduling Order filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 16 pages. |
| Exhibit 2012—Coapt MitraClip filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 9 pages. |
| Exhibit 2013—Demonstrative Comparing POPR to Invalidity Contentions filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 1 page. |
| Exhibit 2016—US20040167539 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 21 pages. |
| Exhibit 2021 — Perlowski Pt. 1 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 100 pages. |
| Exhibit 2021 — Perlowski Pt. 2 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 98 pages. |
| Exhibit 2022—Transcatheter Mitral Valve Repair with MitraClip filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 20 pages. |
| Exhibit 2023—Feldman 2005 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 7 pages. |
| Exhibit 2029 — Maisano 2013 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 10 pages. |
| Exhibit 2030 — Alfieri filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 8 pages. |
| Exhibit 2031—MitraClip Instructions for Use filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 54 pages. |
| Exhibit 2032—Transcript Feldman re Everest filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 3 pages. |
| Exhibit 2034—Edwards Analyst Investor Day filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 49 pages. |
| Exhibit 2035 — Mack filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 3 pages. |
| Exhibit 2036 — Rogoski filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 3 pages. |
| Exhibit 2037 — Piazza filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 15 pages. |
| Exhibit 2040 — Kheradvar filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 11 pages. |
| Exhibit 2042 — Gossl filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 8 pages. |
| Exhibit 2043—Business Monitor Online filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 2 pages. |
| Exhibit 2044—Excerpts MitraClip Physician Site filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 6 pages. |
| Exhibit 2045—Feldman 2009 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 9 pages. |
| Exhibit 2046—LexMachina Case Timing for Delaware filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 1 page. |
| Exhibit 2047—Wood TCT 2018 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 5 pages. |
| Exhibit 2048—Excerpts MitraClip FAQ Physician filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 4 pages. |
| Exhibit 2052—Belden Technologies Inc v. Superior Essex Communications LP filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 3 pages. |
| Exhibit 2055—Letter re Markman Hearing filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 2 pages. |
| Exhibit 2056—WO0003759A2 to Kuehn filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 47 pages. |
| Exhibit 2060—Docket Nov. 21, 2019 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 44 pages. |
| Exhibit 2061—Markman Order filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 19 pages. |
| Exhibit 2062—Claim Construction Stipulation filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 2 pages. |
| Exhibit 2063—Edwards Final Invalidity Contentions filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 262 pages. |
| Exhibit 2064—'097 File History Part 1 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 408 pages. |
| Exhibit 2064—'097 File History Part 2 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 592 pages. |
| Exhibit 2064—'097 File History Part 3 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 386 pages. |
| Exhibit 2064—'097 File History Part 4 filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 291 pages. |
| Exhibit 2065 — Gunnai filed Nov. 27, 2019 in Inter Partes Review of U.S. Pat. No. 7,288,097, Case No. IPR2019-01479, 5 pages. |
| Certificate of Correction Exhibit 2018 filed Oct. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 1 page. |
| Patent Owner Opposing Brief and Conditional Motion for Leave filed Oct. 28, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 17 pages. |
| Petitioners' Reply re CoC filed Nov. 1, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 10 pages. |
| Patent Owner's Surreply re CoC filed Nov. 8, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 10 pages. |
| Petitioners' Reply to POPR filed Dec. 3, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 17 pages. |
| Patent Owner's Surreply to POPR filed Dec. 12, 2019 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 16 pages. |
| Decision Denying Institution filed Jan. 9, 2020 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 9 pages. |
| Edwards Final Invalidity Contentions dated Nov. 6, 2019, 262 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Opening Expert Report of Morten Olgaard Jensen Redacted dated Nov. 11, 2019, 615 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Rebuttal Expert Report of Robert Chang Redacted dated Dec. 6, 2019, 497 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Reply Expert Report of Morten Olgaard Jensen Redacted dated Dec. 20, 2019, 283 pages in Abbott Cardiovascular Systems, Inc. et al. v. Edwards Lifesciences Corp. et al., Case No. 19-149 (MN) (District of Delaware). |
| Statement of Opposition dated Oct. 25, 2019, 2 pages in Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Intellectual Property Office Letter dated Nov. 18, 2019, 4 pages in Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Re-Amended Grounds of Invalidity dated Nov. 29, 2019, 4 pages in Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom). |
| Copelan, “How Dr. Oz Kick-Started a Groundbreaking Device for Patients with Heart Failure,” Parade (Sep. 26, 2018). |
| Cribier et al., “Percutaneous Mechanical Mitral Commissurotomy With a Newly Designed Metallic Valvulotome: Immediate Results of the Initial Experience in 153 Patients,” Circulation 99:793-799 (1999). |
| Dias de Azeredo Bastos et al., “Percutaneous Mechanical Mitral Commissurotomy Performed With a Cribier's Metallic Valvulotome. Initial Results,” Arq Bras Cardiol, 77:126-131 (2001). |
| Freeny et al., “Subselective Diagnostic and Interventional Arteriography Using a Simple Coaxial Catheter System,” Cardiovasc. Intervent. Radiol. 7:209-213 (1984). |
| Ing et al., “The Snare-Assisted Technique for Transcatheter Coil Occlusion of Moderate to Large Patent Ductus Arteriosus: Immediate and Intermediate Results,” J. Am. Col. Cardiol. 33(6):1710-1718 (1999). |
| Rahhal, “Tiny device to ‘zip up’ leaky hearts invented by Dr Oz 20 years ago could save millions, study finds,” Daily Mail (Sep. 26, 2018). |
| U.S. Appl. No. 60/316,892 to Tremulis et al., filed Aug. 31, 2001. |
| Waller et al., “Anatomic Basis for and Morphologic Results from Catheter Balloon Valvuloplasty of Stenotic Mitral Valves,” Clin. Cardiol. 13:655-661 (1990). |
| Decision Denying Institution dated Jan. 9, 2020 in Inter Partes Review of U.S. Pat. No. 6,461,366, Case No. IPR2019-01285, 9 pages. |
| Abbott's Opening Skeleton Argument dated Dec. 4, 2019 in Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom), 105 pages. |
| Edwards' Skeleton Argument dated Dec. 4, 2019 in Evalve, Inc. et al. v Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom), 59 pages. |
| Abbott's Closing Skeleton Argument dated Dec. 16, 2019 in Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom), 88 pages. |
| Edwards' Closing Submissions dated Dec. 16, 2019 in Evalve, Inc. et al. v. Edwards Lifesciences Limited, Claim No. HP-2019-000003 (United Kingdom), 73 pages. |
| Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 179 pages. |
| List of Evidence to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 2 pages. |
| Exhibit 01 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 1 page. |
| Exhibit 02 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 1 page. |
| Exhibit 03 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 2 pages. |
| Exhibit 04 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 2 pages. |
| Exhibit 05 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 1 page. |
| Exhibit 06 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 7 pages. |
| Exhibit 07 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 15 pages. |
| Exhibit 08 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 3 pages. |
| Exhibit 09 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 6 pages. |
| Exhibit 10 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v.Edwards Lifesciences SA et al., (Switzerland), 28 pages. |
| Exhibit 11 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 4 pages. |
| Exhibit 12 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 156 pages. |
| Exhibit 13 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 95 pages. |
| Exhibit 14 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 14 pages. |
| Exhibit 15 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 3 pages. |
| Exhibit 16 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 11 pages. |
| Exhibit 17 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 12 pages. |
| Exhibit 18 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 6 pages. |
| Exhibit 19 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 2 pages. |
| Exhibit 20 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 2 pages. |
| Exhibit 21 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 13 pages. |
| Exhibit 22 to the Statement of Defense dated Jan. 27, 2020 in Evalve, Inc. et al. v. Edwards Lifesciences SA et al., (Switzerland), 2 pages. |
| Abbott Technical Brief (Italian) dated Jan. 10, 2020 in Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., (Italy), 51 pages. |
| Abbott Technical Brief Translation dated Jan. 10, 2020 in Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., (Italy), 49 pages. |
| Edwards Technical Brief (Italian) dated Jan. 10, 2020 in Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., (Italy), 24 pages. |
| Edwards Technical Brief Translation dated Jan. 10, 2020 in Abbott Cardiovascular Systems Inc. et al. v. Edwards Lifesciences LLC et al., (Italy), 20 pages. |
| Extended Search Report dated Jan. 8, 2020 in EP Application No. 19198393. |
| Decision Denying Institution dated Jan. 16, 2020 in Inter Partes Review of U.S. Pat. No. 8,057,493, Case No. IPR2019-01301, 33 pages. |
| Interlocutory Decision dated Jan. 3, 2020 in Opposition of EP1624810, 37 pages. |
| Minutes of the oral proceedings dated Jan. 3, 2020 in Opposition of EP1624810, 23 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 20190261997 A1 | Aug 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13899901 | May 2013 | US |
| Child | 14259826 | US | |
| Parent | 10441531 | May 2003 | US |
| Child | 11962654 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15483523 | Apr 2017 | US |
| Child | 16406583 | US | |
| Parent | 15334992 | Oct 2016 | US |
| Child | 15483523 | US | |
| Parent | 14259826 | Apr 2014 | US |
| Child | 15334992 | US | |
| Parent | 12636471 | Dec 2009 | US |
| Child | 13899901 | US | |
| Parent | 11962654 | Dec 2007 | US |
| Child | 12636471 | US |
