It is well documented that atrial fibrillation, either alone or as a consequence of other cardiac disease, continues to persist as the most common cardiac arrhythmia. Atrial fibrillation may be treated using several methods, including administering anti-arrhythmic medications, and chemical and/or electrical cardioversion. Ablation of cardiac tissue using surgical techniques have also been developed for atrial fibrillation, such as procedures for atrial isolation and ablation of macroreentrant circuits in the atria. For example, the MAZE III procedure creates an electrical “maze” of non-conductive tissue in the atrium that acts to prevent the ability of the atria to fibrillate by creating incisions in certain regions of atrial tissue. In some cases, the MAZE III procedure may include the electrical isolation of the pulmonary veins. While the MAZE III procedure has shown some efficacy in treating medically refractory atrial fibrillation, additional devices and methods of treatment are desirable, especially if they provide advantages over existing techniques.
Described here are devices, systems, and methods for affecting tissue within a body to form a lesion. Some systems may comprise devices having tissue-affecting elements that are configured to be positioned on opposite sides of a tissue and operated simultaneously to form a lesion in the tissue between them. Some systems may also comprise devices that guide the advancement of the tissue-affecting elements to a target tissue region, devices that locate and secure tissue, devices that provide access to the target tissue, and/or devices that may help position the tissue-affecting elements on one or more surfaces of the target tissue. The methods described here may utilize one or more of these devices, and generally comprise advancing a first tissue-affecting device to a first surface of a target tissue, advancing a second tissue-affecting device to a second surface of the target tissue, and positioning the first and second devices so that a lesion may be formed in the tissue between them. In some variations, the devices, systems, and methods described here may be used to treat atrial fibrillation by ablating fibrillating tissue from an endocardial surface and an epicardial surface of an atrium of a heart. Methods of closing, occluding, and/or removing a portion of the target tissue (e.g., the left atrial appendage) are also described.
One variation of a system for affecting tissue within a body may comprise a first device and a second corresponding device. The first and second devices may each comprise an elongate member and one or more tissue-affecting elements. The one or more tissue-affecting elements of the second device may correspond to the tissue-affecting elements of the first device. In some variations, the first device may be configured to be placed on a first surface of a target tissue, and the second device may be configured to be placed on a second surface of the target tissue, where the second surface is opposite the first surface. The first and second devices may be configured to operate the tissue-affecting elements simultaneously to form a lesion in the target tissue at least partially therebetween.
Some variations of the first and second devices may comprise one or more magnetic components. Optionally, the first and second devices may also comprise a longitudinal lumen therethrough. The first and second devices may also comprise one or more temperature sensors. In certain variations, the first and second devices may have a first delivery configuration and a second deployed configuration, where the devices are compressed in the delivery configuration and expanded in the deployed configuration.
The first and second devices may each comprise one or more pre-shaped curves in the second deployed configuration. In some variations, the pre-shaped curves may have varying radii of curvature, and/or may be spiral or funnel shaped. In some devices, the deployed configuration may comprise one or more curves in one or more planes, and may comprise a ring-structure coupled to an expandable net.
The tissue-affecting elements of the devices may affect tissue to form a lesion using any suitable mechanism. For example, the tissue-affecting elements may ablate tissue using cryogenic substances, high intensity focused ultrasound (HIFU), radiofrequency (RF) energy, lasers, heat, microwaves, and the like. Some tissue-affecting elements may ablate tissue using a combination of different mechanisms, as suitable for the target tissue.
Methods of affecting tissue in a body are also described. One variation of a method comprises advancing and positioning a first tissue-affecting device to a first surface of a target tissue, advancing and positioning a second tissue-affecting device to a second surface of a target tissue, where the second surface is opposite the first surface, positioning the first and second tissue-affecting devices so that ablation energy may pass between them, and operating both devices simultaneously to form a lesion in the target tissue. In some variations, advancing the first device may comprise inserting a curved sheath at a location beneath a sternum and advancing the first device through the sheath. Optionally, the method may comprise withdrawing the first and second tissue-affecting devices after the lesion is formed, as well as verifying and assessing the lesion using fluoroscopic, electrical impedance, and thermal imaging techniques. In some variations of the method, the tissue-affecting devices may comprise magnetic components. Tissue-affecting devices may apply a variety of ablation energies, for example, cryogenic, high intensity focused ultrasound, laser energy, radiofrequency energy, heat energy and/or microwave energy. These methods may be used to ablate tissue of the left atrium as part of a procedure to treat atrial fibrillation, but may also be used to target gastrointestinal tissue, as well as cancerous cell masses.
Methods of forming a lesion in the tissue of a left atrium are also described here. One variation of a method may comprise advancing and positioning a first tissue-affecting device in the left atrium through a puncture or access site in a left atrial appendage, advancing a second tissue-affecting device to an external wall of the left atrium, where the second device is positioned opposite to the first device, operating both devices simultaneously to form a lesion in the atrial wall between them, and isolating the left atrial appendage. Optionally, the method may also comprise positioning the first and second devices with respect to each other using one or more magnetic components, and verifying and assessing the lesion using various imaging techniques (e.g. fluoroscopic, electrical impedance, and thermal imaging techniques). In some variations, the first tissue-affecting device may be advanced over a first guide (e.g., guide wire) into the left atrium to circumscribe the base of a pulmonary vein, and the second tissue-affecting device may be advanced over a second guide (e.g., guide wire) to circumscribe the trunk of the pulmonary vein on the external atrial wall. Additionally or alternatively, the first guide wire and the first tissue-affecting device may be advanced into the left atrium to circumscribe the bases of two or more pulmonary veins, while the second guide wire and the second tissue-affecting device may be advanced over the external atrial wall to circumscribe the trunks of two or more pulmonary veins. In some variations, isolating the left atrial appendage may comprise positioning an occlusion device comprising a rounded disc with one or more grooves circumscribing the outer perimeter of the disc, wherein the disc is sized and shaped to be constrained in an ostium or base of the left atrial appendage.
Also described here are kits for affecting tissue within a body. One variation of a kit may comprise a first device with one or more tissue-affecting elements and a longitudinal lumen therethrough, where the first device has a first compressed configuration and a second expanded configuration, a second device with one or more tissue-affecting elements and a longitudinal lumen therethrough, where the first and second devices are configured to operate simultaneously to form a lesion that spans at least a portion of tissue between them. In some variations, the kit optionally comprises first and second devices as described above, where the first and second devices also comprise one or more magnetic components and/or one or more temperature sensors. In certain variations, the kit may also comprise a closure member with an elongate body and a distal snare, where the elongate body may comprise a longitudinal lumen therethrough, a piercing member that is configured to be advanced through the lumen of the elongate body, a first and second cannula, and a first and second guide wire.
The system and methods described herein may be used to affect any portion of tissue within a body to form a lesion, and/or otherwise electrically isolate a portion of tissue. For illustrative purposes, these devices and methods are described in the context of lesion formation in the tissue of the left atrium for the treatment of atrial fibrillation, and may include the closure of the left atrial appendage. For example, methods for affecting tissue to treat atrial fibrillation may comprise accessing the pericardial space of the heart, creating an access site through the left atrial appendage (LAA), advancing a tissue-affecting device intravascularly and/or through the LAA to contact an endocardial surface of the left atrium, advancing another tissue-affecting device via the pericardial space to contact an epicardial surface of the heart, and affecting tissue from either or both the endocardial and epicardial surfaces. In some variations, a LAA access/exclusion device may be used to stabilize the LAA for the advancement of devices therethrough, as well maintain hemostasis by closing and/or opening the LAA during and/or at the conclusion of the procedure. While the systems and methods disclosed here are described in the context of affecting cardiac tissue, it should be understood that these devices and methods may be used to affect a variety of tissues, such as the skin, heart, liver, etc., as well as to treat a variety of conditions, including various cardiac deficiencies, tumors, gastrointestinal deficiencies, etc.
I. Anatomy
II. Devices
Pericardial Access Device
In order to access certain portions of the heart, it may be useful to place one or guide elements in the pericardial space around the heart. Various devices may be used to provide access to the pericardial space for the placement of a guide element into the pericardial space for the advancement of subsequent devices to the heart. Some pericardial access devices may be configured to provide an access pathway from an initial access site (e.g., a sub-thoracic region, an intercostal region, etc.). For example, a pericardial access device may comprise a sheath with one or more curves, and one or more needles, guide elements, tissue-piercing elements, etc. to create a pathway through the pericardium to access the pericardial space. In some variations, the one or more needles, guide elements, tissue-piercing elements, etc. may be sized and shaped to correspond with the one or more curves in the sheath. One example of a sheath with one or more curves is shown in
The curved region (1706) may have one or more pre-shaped curves, and/or may be flexible or bendable using a suitable actuating mechanism controlled by the sheath actuator at the proximal portion (1704). The curved region (1706) may serve to generally orient the sheath toward the heart upon insertion at an initial access point beneath the sternum, and/or may have a particular radius of curvature to help guide the sheath under the rib cage to the heart. In some variations, the curvature of the curved region (1706) may be locked or fixed, e.g., the curved region (1706) is first actuated to attain a desired degree of curvature, then locked to retain that desired curvature. Suitable locking mechanisms may include, for example, maintaining the tension of a wire that may be inserted through the wire lumen (1710), or immobilizing the hinge mechanisms to a desired configuration. A flexible or soft curved region may be locked into position by fixing the configuration (e.g., curvature, tension, etc.) of the wire within the wire lumen (1710). Some variations of a sheath may have a pre-shaped curve, where the radius of curvature is determined at the time of manufacture, and remains unchanged as the sheath is used. The radius of curvature of the curved region may be adjusted for sheaths that are inserted at different initial access points. For example, the radius of curvature of a curved region of a sheath to be inserted at an intercostal access site may be different from the radius of curvature of a curved region of a sheath to be inserted at a sub-thoracic access site.
The curved region (1706) may be made of a flexible or bendable material, or may be made of a substantially rigid material arranged in articulating segments that allow for the curved region (1706) to bend when actuated. The curved region (1706) may be integrally formed with the body of the sheath (1702), or may be separately formed and attached to the sheath (1702). For example, the curved region (1706) may be made of polymeric tubing and/or materials such as Pebax®, nylon, fluoropolymers (e.g., PTFE, FEP), polyethelene, Teflon®, polyethylene terephthalate (PET), Tecothane®, etc. In some variations, the curved region (806) may be made of a polymeric tube with reinforced stainless steel or nitinol. Where the curved region (1706) is made of a substantially rigid material, for example, stainless steel, nickel titanium, nitinol, cobalt alloys (e.g. nickel-cobalt, cobalt-nickel-chromium-molybdenum), and/or polymers such as PEEK, polyethylene (HDPE), polyimide, etc., the curved region may be slotted or segmented to allow bending to occur. In some variations, a curved region (1707) may have one or more slots (1705), as illustrated in
An articulating sheath such as is shown and described above may be useful for accessing the heart (1720) where the abdomen (1724) of the subject (1730) may limit the angle at which the sheath (1702) may be positioned. Certain subject anatomy, such as a smaller abdomen (1724) may provide a large range of maneuverability for the sheath (1702), while a larger abdomen (1724) may limit the range of maneuverability for the sheath. Providing one or more curved regions may allow the heart to be more readily accessed where subject anatomy limits the range in which the sheath may be positioned. For example, providing one or more curved regions may help to reduce the force that may be required to position the sheath (1702), and may provide additional access paths to the heart in the event the originally planned pathway becomes unavailable.
Closure Device
Some methods for treating atrial fibrillation may comprise accessing an endocardial surface of the left atrium through the LAA via the pericardial space. Methods that utilize the LAA as an entry port may also comprise closing and/or opening the LAA during the procedure (e.g., to advance devices therethrough) to maintain hemostasis. Optionally, methods may also comprise excluding the LAA at the conclusion of the procedure. Such a device may be used during the procedure to stabilize the LAA so that tissue-affecting devices may be advanced through the LAA into the left atrium, and may be used to at the conclusion of the procedure to permanently close off or otherwise occlude the LAA. One example of a device that may be capable of locating, securing, manipulating, stabilizing, closing and/or excluding the LAA is depicted in
The elongate body (202) may have any appropriate shape, for example, the elongate body may be substantially straight (as depicted in
As depicted in
The distal extension (205) may be integrally formed with elongate body (202), or separately formed and attached to the elongate body (e.g., by welding, melding, brazing, adhesives, etc.). The distal extension (205) may be made of rigid and/or flexible materials, and may be made of the same or different materials as the elongate body. The elongate body and/or distal extension may be made of polymeric materials such as Pebax®, polyethylene, and/or other thermoplastic materials with various durometers or densities, and/or any polymers that may be tapered or graduated for varying degrees of flexibility. Additionally or alternatively, the elongate body and/or distal extension may be made of metallic materials such as nitinol, stainless steel, etc. The looped closure assembly (206), distal extension (205), elongate body (202), and/or portions thereof may comprise visualization markers, such as fluorescent markers, echogenic markers, and/or radiopaque markers, that permit the closure device to be visualized using a variety of imaging modalities. As with the elongate body (202) described above, the distal extension (205) may also be steerable. In some variations, the distal extension (205) may be steered independently from the elongate body, while in other variations, the distal extension (205) may be steered together with the elongate body. For example, a steering mandrel that may be used to steer the elongate body may also be coupled to the distal extension so that the extension may be steered in concert with the elongate body. Alternatively, there may be a first mandrel for the steering the elongate body and a second mandrel for steering the distal extension independently from the elongate body. Optionally, the distal extension may have one or more pre-shaped curves which may help to navigate the closure device (200) to a target tissue region.
In some variations, the distal extension (205) may comprise one or more lumens that may extend from the distal-most end of the extension to the proximal portion of the closure device (e.g., to the handle portion). A lumen in the distal extension may slidably retain a portion of the looped closure assembly such that the dimensions of the loop may be adjusted. For example, the lumen of the distal extension (205) may slidably retain the looped closure assembly (206), which may comprise a distal loop (203). The distal loop (203) may comprise a snare loop and a suture loop that may be releasably coupled along the circumference of the snare loop. The distal loop (203) may be made of polymeric materials such as Pebax®, and/or metallic materials, such as nitinol, and/or any elastic, malleable, deformable, flexible material. The portion of the distal loop that extends outside of the extension, i.e., the external portion of the distal loop, may be adjustable using an actuator at the proximal handle portion. Adjusting the length of the external portion of the distal loop (203) may help to snare and/or close, or release and/or open, a LAA or any anatomical protrusion. While the distal loop (203) may have the shape of a circle, it may also have other shapes, e.g., an ellipse, oval, triangle, quadrilateral, etc. In other variations, the looped closure assembly may be configured (e.g. knotted, looped, coiled, etc.) for other functions, such as locating and securing tissue. For example, the looped closure assembly may optionally comprise tissue graspers, hooks, or other such tissue engagement components that may help secure and retain a tissue portion.
The looped closure assembly (206) may have an expanded (e.g., open) configuration, and a tightened (e.g., closed) configuration, where the circumference of the loop in the tightened configuration is smaller than in the expanded configuration. For example, a distal loop with an elliptical shape in the open configuration may have a length along the minor axis (e.g., the shortest dimension of the ellipse) from about 15 mm to about 50 mm, e.g., about 20 mm, and a length along the major axis (e.g., the longest dimension of the ellipse) from about 15 mm to about 50 mm, e.g., about 40 mm. A distal loop in the closed configuration may have a diameter equivalent to about 5 mm to about 10 mm, e.g., 6 mm. The looped closure assembly (206) may be tightened or cinched to encircle and secure the LAA, and in some variations, may be able to close the LAA after it has been secured, if desirable. Optionally, the looped closure assembly (206) may be releasably coupled to the closure device such that after the LAA is encircled and secured by the distal loop (203), a knot or locking element may be deployed to retain the tension on the distal loop, which may then be released from the closure device. For example, a looped closure assembly may have a releasable suture loop that is tightened over the LAA and then released from the closure device. The tension on the suture loop may be locked so that the looped closure assembly may be proximally withdrawn from the suture loop. Optional closure elements, such as sutures, graspers, clips, staples, and the like, may be included with the looped closure assembly to help close the LAA. For example, additional closure features, e.g., graspers or staples, may be included at the tip of distal extension (205) that may act to secure the LAA. A looped closure assembly may also comprise one or more energy sources distributed along the length of the distal loop, where the energy sources may be used to ablate tissue or induce tissue fusion. Alternatively or additionally, the looped closure assembly (206) may be actuated in conjunction with other devices advanced through the working channel (208) to secure and position the closure device with respect to the LAA.
Various types of devices may be inserted through the working channel (208) of the elongate body (202) as may be desirable. In some variations, a vacuum device may be inserted through working channel (208), while in other variations, alignment devices, guide elements, grasper devices, visualization devices, ablation devices, and/or cutting devices may be inserted through the working channel. Variations of the closure device may have a multi-lumen elongate body, where each lumen may be a working channel for one or more different devices. For example, the elongate body (202) may have multiple working channels for the insertion of different devices. Additionally or alternatively, the elongate body (202) may comprise working channels for the injection of liquid or gas fluids, as well as the application of therapeutic and/or chemical agents. The working channel (208) may have any cross-sectional shape as may be suitable for the devices to be inserted therethrough, for example, circular, rectangular, etc.
The closure device (200) may comprise mechanisms to control the bending and/or steering of the elongate body, as well as adjust the length of the distal loop that extends outside of the distal extension. For example, these functions may be controlled by levers and/or knobs at the handle portion (204). The handle portion (204) may comprise a housing (214), a loop actuator (212), and a working channel actuator (210). The housing (214) may enclose at least a portion of the actuators that control the use of the elongate body, the looped closure assembly, and the device in the working channel of the elongate body. For example, loop actuator (212) may regulate the tension on the distal loop of the looped closure assembly, and control the circumference of the external portion of the distal loop, e.g. decrease it to encircle and/or close the LAA, and increase it to release the LAA. In some variations, the loop actuator (212) may be a slider configured to adjust the circumference of the distal loop (203). In variations where the distal loop comprises a releasable suture loop, the loop actuator may also comprise a fob that initially couples the suture loop with the closure device and may be pulled to release the suture loop from the closure device. The working channel actuator (210) may comprise one or more buttons, sliders, levers, knobs, and the like that are configured regulate the operation of the device(s) in the working channel(s) of elongate body (202). For instance, the working channel actuator (210) may be a grasper actuator, and/or vacuum actuator. Optionally, handle portion (204) may also comprise one or more buttons, sliders, levers, and/or knobs that may be used to navigate the LAA access device through the vasculature to access the LAA, for example, by rotating, pulling, pushing, bending, or otherwise manipulating steering mandrels. Other features of a closure device and methods of use are described in U.S. patent application Ser. No. 12/055,213 (published as U.S. Pub. No. 2008/0243183 A1), which is hereby incorporated by reference in its entirety. Another example of a closure device and methods of use are described in U.S. patent application Ser. No. 12/752,873, entitled “Tissue Ligation Devices and Controls Therefor,” filed Apr. 1, 2010, which is hereby incorporated by reference in its entirety.
LAA Access Device
As described above, a variety of devices with different functions may be inserted through the working channel(s) of the elongate body of a closure device to secure and/or otherwise manipulate a portion of tissue. In procedures where access to an internal tissue structure may be desired (e.g. accessing a lumen of a hollow organ or vessel), an access device may be inserted through the working channel of the closure device after the closure device has been advanced at or near the target tissue (e.g., by advancing the closure device over a guide element). Access devices may create a way for the internal portion of a tissue to be accessed from outside the tissue. In some variations, access devices may create an incision, puncture, and/or opening, etc., which may be dilated to allow access to devices larger than the initial opening. Optionally, some variations of an access device may also comprise a guide wire that may be advanced into the created access site. One example of such a device is shown in
Corresponding Ablation Devices
Another example of a device that may be advanced through the working channel(s) of the elongate body of a closure device is a tissue-affecting device. Devices that affect tissue may generally comprise one or more tissue-affecting elements, arranged in various patterns. In some variations, two or more tissue-affecting devices may be positioned along a target tissue, and used to affect the tissue in a desired pattern, where the tissue-affecting elements may be operated simultaneously or sequentially. In some variations, the two or more tissue-affecting devices may be placed across each other on opposite sides of tissue such that the tissue between them is affected. One example of a tissue-affecting device is an ablation device. Ablation devices may be provided for procedures that aim to ablate a portion of tissue that is abnormal, for example, cancerous tissue, or arrhythmic cardiac tissue. While affecting tissue by ablation is described in detail here, tissue may be affected in other ways, including by excision, occlusion, manipulation and the like. As described below, an ablation device may be used to ablate fibrillating atrial tissue, which may help to prevent the conduction of the irregular or asynchronous pulses in one tissue region to another tissue region.
In some variations, ablation devices may be used to create a lesion in the fibrillating atrial tissue. For the treatment of atrial fibrillation, one or more tissue-affecting devices, such as ablation devices, may be positioned on the endocardial surface and/or the epicardial surface of the left atrium. One example of an endocardial ablation device that may be inserted through a closure device is shown in
As shown in
The shape of the ablation array (408) as shown in
The ablation array (408) may be made from a flexible or shape-memory material, such that it may be advanced to the target tissue in a substantially straight configuration, and may be deployed and contacted to tissue in a curved configuration. In some variations, the ablation array is made of a different material from the remainder of the ablation device (400), and may have different mechanical properties. For example, the proximal portion (405) of the elongate body may be made of a first material, while the distal portion (407) and/or the ablation array may be made of a second material. Examples of materials that may be suitable for the proximal portion (405) and/or the distal portion (407) of the elongate body may include metal alloys such as nickel titanium alloy, stainless steel, and/or any polymers, such as polyethylene, polyurethane, polypropylene, polytetrafluoroethylene, polyimide, etc., and/or any combinations thereof. In some variations, an ablation array may be integrally formed with the proximal portion of the ablation device, or may be attached via an articulating hinge. The ablation array may also be attached by other mechanical mechanisms, such as a living hinge, pivot joint, ball joint, etc, which may allow the ablation array to move with respect to the proximal portion of the ablation device (e.g., with two or more degrees of freedom).
The handle portion (404) located at the proximal end of elongate body may comprise actuating elements that control the movement and/or action of the elongate body and ablation array. In some variations where endocardial ablation device (400) is manually operated, the handle (400) may be ergonomic, while in other variations where the device is mechanically/electrically operated, handle (400) may comprise an interface to receive and execute instructions from a computing device. The handle portion (404) may comprise an ablation array actuator (414), which may be used to regulate application of ablation energy/substances to the ablation array to the target tissue (e.g. frequency, duty cycle, magnitude/amplitude, etc.). Additionally, the handle portion (404) may comprise an actuating mechanism that controls the movement (e.g., bending, flexing, etc.) and position of elongate body (402). The handle portion (404) may also comprise an interface to the ablation source(s) (406), and provide a conduit or conduction pathway from the ablation source(s) (406) to the ablation array. For example, the ablation source (406) may comprise a reservoir of cryogenic substances (e.g., for cryo-ablation), which may be transported through a lumen in the elongate body (402) to the ablation array. Alternatively or additionally, the ablation source (406) may comprise a source of radioactive substances (e.g., radioactive seeds or fluids), and/or a light beam source (e.g., for laser ablation), and/or an ultrasound source (e.g., for HIFU ablation), and/or a radiofrequency source, and the like, which may be delivered or transmitted from the handle portion to the ablation array. In some variations, different ablation sources may be used together in the same ablation device.
Depending on the tissue to be ablated and the desired ablation pattern (e.g. lesion geometry and size) desired, a second ablation device may be provided, where the second ablation device corresponds to the first ablation device. A second ablation device may increase the tissue ablation area and/or may otherwise alter the ablation characteristics of the first ablation device (e.g. by constructive or destructive interference). For the purposes of ablating tissue of a left atrium, a second ablation device may be provided to help ensure that the lesion formed by ablating tissue spans at least portion of tissue that is between them. In the treatment of atrial fibrillation it may be desirable to electrically isolate the fibrillating tissue from other tissues. In some variations, the formation of a lesion that spans the entire thickness of the atrial wall (e.g., from the endocardial surface to the epicardial surface) using one or more ablation devices may improve the electrical isolation of a portion of the atrial wall from other portions of the heart. Accordingly, in some variations, ablation devices may be placed on opposite sides of a tissue wall such that a lesion that spans a substantial portion of the tissue wall between the ablation devices may be formed. In some variations, positioning a first ablation device on an interior wall (endocardial surface) of the left atrium, and positioning a second ablation device on an exterior wall (epicardial surface) of the left atrium opposite to the first ablation device, may help form a lesion that spans at least a portion of the tissue between the first and second ablation devices.
The handle portion (504) located at the proximal end of elongate body may comprise actuating elements that control the movement and/or action of the elongate body and ablation array. In some variations where the endocardial ablation device (500) is manually operated, the handle (500) may be ergonomic, while in other variations where the device is mechanically/electrically operated, the handle (500) may comprise an interface to receive and execute instructions from a computing device. The handle portion (504) may comprise an ablation array actuator (514), which may be used to regulate application of ablation energy/substances to the ablation array to the target tissue (e.g. frequency, duty cycle, magnitude/amplitude, etc.). In some variations, the handle portion (504) may be in communication with the handle portion (404) of the endocardial ablation device (400), such that ablation energy from both ablation devices may be applied in-phase or out-of-phase to form a desired ablation wavefront and/or profile. Additionally, the handle portion (504) may comprise an actuating mechanism that controls the movement and position of elongate body (502). The handle portion (504) may also comprise an interface to ablation source(s) (506), and provide a conduit or conduction pathway from the ablation source(s) (506) to the ablation array. For example, the ablation source (506) may comprise a reservoir of cryogenic substances (e.g., for cryo-ablation), which may be transported through a lumen in the elongate body (502) to the ablation array. Alternatively or additionally, the ablation source (506) may comprise a source of radioactive substances (e.g., radioactive seeds or fluids), and/or a light beam source (e.g., for laser ablation), and/or an ultrasound source (e.g., for HIFU′ ablation), and/or a radiofrequency source, and the like, which may be delivered or transmitted from the handle portion to the ablation array. In some variations, different ablation sources may be used together in the same ablation device.
Variations of Ablation Arrays
While the ablation devices depicted and described in
Any of the ablation arrays described above may optionally comprise one or more temperature sensors. Temperature sensors may be used to measure the ablation energy that has been applied to a tissue, and may be used to evaluate the degree to which tissue is ablated. The measurement of temperature changes in the tissue during the application of ablation energy may be used to regulate the duration, power, and/or frequency of the ablation energy (e.g., by providing feedback information to the ablation array and/or ablation array controllers). Monitoring the temperature of the tissue during ablation may also help prevent excessive or harmful damage to peripheral tissues. The one or more temperature sensors may be thermocouples, thermsistors, thermal resistive sensors (RTD), and the like. One example of an ablation array with temperature sensors is depicted in
In the variations depicted in
Occlusion Device
As described previously, some methods may include steps to help maintain hemostasis in the course of the procedure for the treatment of atrial fibrillation. For example, in procedures where access to an endocardial surface of the heart is gained using the LAA as a port, it may be desirable to close and/or exclude the LAA to maintain hemostasis and/or help prevent thrombosis. In some variations, a procedure for the treatment of atrial fibrillation may also include the temporary or permanent closure, and/or occlusion, and/or removal of the left atrial appendage.
The elongate body (702) may be made from one or more rigid and/or flexible materials. In some variations, the elongate body (702) may be steerable. An insert port may comprise one or more apertures for the insertion of fluids or devices through the elongate body (702). For example, the insert port (704) may comprise a guide wire aperture (714) and a fluid lumen (716). The guide wire aperture (714) and the fluid lumen (716) may each have independent lumens that may merge into one lumen at a bifurcation (717) of the insert port (704), or may each have separate lumens in the elongate body (702). The guide wire aperture (714) may be continuous with the guide wire lumen (708), and the fluid lumen (716) may be continuous with a cavity of the expandable member (706), such that the introduction of fluid into or out of the fluid lumen (716) may expand or constrict the expandable member. Optionally, the insert port (704) may also comprise actuation mechanisms for navigating and adjusting the shape of the elongate body (702), as well as control the motion of a guide wire, and the expansion of the expandable member (706).
The expandable member (706) may be any structure that comprises a first small profile and a second larger profile, for example, a balloon or an articulating polygonal structure, e.g. rectangular prism or tetrahedron, and the like. The expandable member (706) may be sized and shaped to fit within the guide wire lumen (208) of the closure device (200) so that it may be advanced and/or withdrawn through the lumen (208). In some variations, the expandable element (706) may have a first collapsed configuration, and a second expanded configuration. For example, the rounded expandable element (706) shown in
Another variation of a device that may be used for occluding the LAA is depicted in
The above-described devices may be used to secure, ablate, and excise a portion of tissue to help alleviate the symptoms of atrial fibrillation. For example, the devices above may be used to secure a LAA, ablate atrial tissue in the proximity of the LAA and the pulmonary veins, and to close, and/or occlude, and/or remove the LAA. While the description below provides methods of securing, ablating, and excising tissue of the left atrium and/or LAA, it should be understood that the methods may be used to perform similar procedures on the right atrium, as well as other vascular structures or organs. Similar methods may also be used to secure, ablate, and excise tissues and/or organs that have one or more cavities therethrough, e.g. stomach, intestine, bladder, etc., for a variety of indications.
III. Methods
Methods for ablating tissue for the treatment of atrial fibrillation may generally comprise accessing targeted cardiac tissue regions, advancing ablation arrays to the targeted tissue regions, ablating the tissue regions, and withdrawing the ablation arrays once the desired degree of tissue ablation has been attained. Additionally, some methods may include the closure of the left and/or right atrial appendages, which may help reduce the risk of thrombosis and may help maintain hemostasis. Some variations of methods for tissue ablation may comprise ablating the tissue from an endocardial surface, an epicardial surface, or both. Ablation devices may access an endocardial surface of the left atrium intravascularly, and/or through the LAA via the pericardial space. Once the one or more ablation devices have been placed on the endocardial and/or epicardial surface(s), the ablation devices may be activated sequentially and/or simultaneously to achieve the desired degree of tissue ablation. Ablation array activation sequences may be repeated as may be desirable, and may comprise applying ablation energy pulses (from either or both of the endocardial and epicardial ablation arrays) of varying duration, frequency, duty cycle, power, intensity, etc. The ablation array(s) may be re-positioned to ablate tissue at various desired locations. Once all the desired tissue regions have been ablated, the ablation arrays may be withdrawn. In variations where the LAA is used to access the endocardial surface on the left atrium, the LAA may be closed and/or excluded.
Epicardial and Endocardial Ablation
One variation of a method that may be used to electrically isolate tissue in the left atrium and/or LAA is depicted as a flowchart in
As described previously, the endocardial side of the left atrium may be accessed intravascularly and/or from the LAA via the pericardial space. The access path into the left atrium may be selected based on the targeted anatomical features in the left atrium such that the path length of the catheter and/or ablation devices may be reduced. The access path may also be selected to reduce the maneuvering, manipulating, bending, torquing, etc. that may be required to position the catheter and/or devices at the targeted tissue site in the left atrium. For example, an endocardial ablation device may access the left atrium using either an intravascular retrograde approach or an antegrade transseptal approach. Entering the left atrium via an intravascular antegrade transseptal approach may allow access to the left pulmonary veins while reducing the maneuvering, manipulating, bending, torquing, etc. of the distal portion of the device. Entering the left atrium via an intravascular retrograde approach may allow access to the right and left pulmonary veins while reducing the maneuvering, manipulating, bending, torquing, etc. of the distal portion of the device. Alternatively or additionally, entering the left atrium through the LAA via a pericardial approach may allow access to the right pulmonary veins without much maneuvering, manipulating, bending, torquing, etc. of the distal portion of the device. Any of these approaches may be used to position an endocardial ablation device in the left atrium. In some variations, a first endocardial ablation array may enter the left atrium through an intravascular approach, and a second endocardial ablation array may enter the left atrium through the LAA via a pericardial approach.
One example of a method (830) that comprises accessing the endocardial surface of the left atrium both intravascularly and through the LAA via the pericardial space is depicted in
While the steps of the method (830) have been described in the sequence as depicted in
The methods described above ablate the tissue of the left atrium and/or pulmonary veins from both the endocardial and epicardial surfaces, either simultaneously or sequentially. Placement of the ablation arrays on both the endocardial and epicardial surfaces may help ablate atrial tissue from both sides. Ablating tissue simultaneously from both sides may help promote the formation of a lesion that spans a significant portion of the thickness of the tissue between the ablation arrays. A lesion that spans a significant portion of atrial tissue thickness may help to electrically isolate fibrillating tissue. The application of ablation energy (e.g., phase, magnitude, pulse sequence, etc.), type of ablation energy (e.g., radiofrequency, laser, high intensity focused ultrasound, cryogenic agents, microwave energy, heat energy, etc.), and the shape and size of ablation arrays may be varied according to the geometry of the tissue and the ablation profile desired. For example, the endocardial ablation array may ablate tissue cryogenically, while the epicardial ablation array may ablate tissue with heat energy. Alternatively, the endocardial ablation array may ablate tissue using heat energy, while the epicardial ablation array may ablate tissue cryogenically. In other variations, the endocardial ablation array may ablate tissue using HIFU, while the epicardial ablation array may ablate tissue using microwaves. The type(s) of ablation energy used and the shape of the ablation array may be selected to limit ablation of non-target peripheral tissue.
While the methods and devices described here may be used to ablate cardiac tissue, it should be appreciated that the methods and devices described here may be adapted to ablate any tissue from any two tissue surfaces. For example, endocardial and epicardial ablation arrays may be adapted to ablate a tumor cell mass from one or more surfaces. Endocardial and epicardial ablation arrays may also be used to ablate tissue of a hollow organ (e.g., stomach, bladder, lungs, vascular structures, etc.) by positioning them opposite each other on both the inside and outside surfaces. When two ablation arrays are placed on opposite sides of tissue, they may ablate tissue therebetween in any variety of patterns, some of which are shown in
The ablation pattern created in the tissue may be monitored using one or more one or more temperature sensors on either or both the endocardial and epicardial arrays. For example, as depicted in
One variation of a method for ablating tissue from both the endocardial and epicardial surfaces is depicted in
Various devices may be introduced into the epicardial space via an incision or puncture in the pericardium.
Optionally, LAA stabilizing devices may comprise additional LAA attachment features that may further secure the LAA after it has been stabilized, for example, as depicted in
Various devices may be advanced over the guide wire (1031) to access the internal portion of LAA (1000) and left atrium (1003). The guide wire (1031) may be navigated and controlled by actuator (1028c). Ablation devices may be advanced over the guide wire (1031) to ablate asynchronous tissue for the treatment of atrial fibrillation.
Ablation array (1042) of the endocardial ablation device (1040) may be integrally formed with the proximal portion of the ablation device (1040), or may be attached via an articulating hinge (1043). In some variations, an ablation array may comprise ablation elements and/or magnetic elements, as previously described above. The endocardial ablation device (1040) may have a first delivery configuration, where the ablation array (1042) has a narrow profile (as shown in
Once the ablation array (1042) of the endocardial ablation device is positioned at a region of tissue in the left atrium, e.g. around the base of pulmonary vein (1007b), an epicardial ablation device may be aligned and placed on the epicardial surface of the atrium (1003). A second guide cannula (1052) may be inserted in any of the access sites previously described and depicted in
Endocardial and epicardial ablation devices may comprise alignment features, which may help ensure a particular orientation of one ablation device with respect to another, and may also create an intimate contact between the ablation devices and the tissue to be ablated. In the variation of the ablation devices described here, the attractive forces between the magnets on one or both of the epicardial and endocardial ablation devices may align the devices to one another.
While the devices and methods above are directed towards ablating tissue endocardially and epicardially to form an ablation pattern that circumscribes the base of a pulmonary vein, other ablation patterns and profiles may be also be used for the treatment of atrial fibrillation. Examples of other ablation patterns are schematically illustrated in
During and/or after tissue ablation, the progress of the ablation and the lesion size may be monitored and verified. Lesion formation may be monitored functionally and/or anatomically. For example, lesion formation may be monitored by heat transfer measurements, electrocardiography mapping, ejection fraction, local electrogram amplitude reduction and mapping, impedance tomography, ultrasound, fluoroscopy, and other suitable functional metrics or imaging modalities. Based on these measurements and images, the rate, size, and other characteristics of lesion formation may be modified, e.g., by adjusting power and wavelength of the ablation energy, to achieve the desired degree of electrical isolation. In some variations, lesion formation may be measured in terms of the change in the tissue temperature across the thickness of the tissue. For example, endocardial and epicardial ablation arrays may each comprise temperature sensors as previously described may be pressed into the atrial wall tissue to measure the temperature on either side of the atrial wall. In some variations, either the endocardial or the epicardial ablation array has a temperature probe, so that the heat transfer front from the other ablation array may be measured. The temperature probe may also be a separate device that is advanced to the desire target tissue region.
Once the desired portion of tissue has been ablated (e.g., verified that a lesion of a desired size and shape has been formed), the ablation devices and positioning catheters may be removed. The alignment feature that couples the endocardial ablation array (1042) with the epicardial ablation array (1062) may be deactivated, either mechanically (e.g., by applying a force stronger than, and opposite to, the coupling force) or electrically (e.g., by turning off the electro-magnet). The endocardial ablation device (1040) and the epicardial ablation device (1060) may be removed sequentially or simultaneously, as may be appropriate. The endocardial guide wire (1031) may be kept in place to facilitate the navigation of any additional devices to the left atrium and/or LAA, however, in other variations, the guide wire (1031) may be removed.
Optionally, a method for the electrical isolation of tissue in the LAA and/or left atrium may comprise a step that electrically isolates the LAA.
As described above, the neck of LAA may be encircled and cinched by a suture snare, however, other mechanisms may be included to close and/or occlude the LAA cavity. As shown in
A variety of expandable members may be used to occlude and/or exclude the LAA. For example, an inflatable expandable member, such as a balloon similar to the expandable member (1086), may be used to occupy the LAA cavity, preventing the escape of, or continuing development of, thrombi in the LAA. In another variation shown in
Endocardial Ablation
While some methods for the treatment of atrial fibrillation may ablate tissue in the left atrium both endocardially and epicardially, other variations of ablating tissue in the left atrium, and subsequently occluding and/or excising the LAA may be used. One example of a method that ablates an endocardial surface of a left atrium is shown in
While the method described above uses one endocardial ablation array for ablating the tissue of the left atrium from an endocardial side, other methods may use two endocardial ablation arrays. One example of a method that uses two endocardial ablation arrays for ablating atrial tissue on an endocardial side is depicted in
While the steps of the method (1330) have been described in the sequence as depicted in
Examples of ablation patterns that may be formed by endocardial ablation method (1300) are shown in
Epicardial Ablation
Ablation of tissue of the LAA and left atrium may be achieved by epicardial ablation. An example of a method (1500) for epicardial ablation is shown in
Returning to the figures, cannula (1906) may be advanced to tissue structure (1904), as shown in
Once cannula (1906) is positioned at or near the tissue structure (1904), first guide (1908) may be advanced out of the distal end of cannula (1906), as shown in
The second guide (1910) may then be advanced from the distal end of cannula (1906), as depicted in
Once the lumens (1912) of the first (1908) and second (1910) guides are aligned, a guide element (1902) may be advanced through the lumen (1910) of first guide (1908) such that it exits the distal end of first guide (1908) and enters the lumen of the second guide (1910) (or vice versa). The guide element (1902) may then be advanced through the second guide (1910) (or the first guide (1908)) and the first (1908) and second (1910) guides may be withdrawn through the cannula, as shown in
In some variations, the ends of the guide element (1902) may be pulled proximally to cinch the distal exposed portion of guide element (1902) (e.g., the portion of guide element extending from the distal end of cannula (1906)) around the tissue structure (1904), as shown in
Additionally or alternatively, one or more devices may be advanced over the guide element (1902) to place the device at or around the tissue structure (1904). In some variations, one or more ablation devices may be advanced over the guide element, such as ablation device (1918) shown in
Examples of ablation patterns that may be formed by epicardial ablation method (1500) are shown in
IV. Systems
Also described herein are systems for affecting tissue within a body to form a lesion. In general, the systems may comprise devices that have one or more tissue-affecting elements, together with additional components that help to locate and secure the target tissue. For example, the system may comprise a first and second device, where each of the devices comprises an elongate member and one or more tissue-affecting elements. The first and second devices may be separate from each other, but have corresponding geometries and sizes so that operating the tissue-affecting elements may form a lesion in the tissue between them. These devices may have any geometry (e.g., size, number of curves, radii of curvature, etc.), one or more configurations (e.g., a delivery configuration and a deployed configuration) and may apply a variety of tissue-affecting mechanisms (e.g., cryogenic substances, lasers, high intensity focused ultrasound, radiofrequency energy, heat, microwave, etc.). The tissue-affecting elements for a given device may deliver a combination of one or more types of tissue-affecting mechanisms. The tissue-affecting elements may be any of the ablation elements previously described. Some devices may also comprise magnetic components so that the attractive force between the magnets may cause the first and second devices to be positioned in a certain orientation with respect to each other, e.g. opposite one another. Systems may also include actuators and controllers that regulate the application of the tissue-affecting mechanisms. For example, tissue-affecting elements may be configured to be operated simultaneously, and/or apply energy to the tissue in a pre-programmed manner. A controller may be coupled to the tissue-affecting elements to synchronize their operation temporally (e.g., to affect tissue in-phase or out-of-phase, synchronously or asynchronously) and spatially (e.g., to affect one region of tissue without affecting another, to affect one region of tissue from more than one surface, etc.). In some variations, a controller may be configured to receive temperature data measured at the target tissue site to regulate the operation of the tissue-affecting elements.
Some systems for affecting tissue within a body may include devices that aid in accessing and securing the tissue, as well as positioning the tissue-affecting elements with respect to the tissue. For example, some systems may comprise a closure device (such as described above) may be included to locate and secure target tissue, a piercing member, one or more guide cannulas, and one or more guide wires. These devices may be configured to be inserted through, or advanced over, each other, which may be desirable for minimally invasive procedures.
Although the foregoing invention has, for the purposes of clarity and understanding been described in some detail by way of illustration and example, it will be apparent that certain changes and modifications may be practiced, and are intended to fall within the scope of the appended claims.
This patent application is a continuation of U.S. patent application Ser. No. 13/086,389, filed Apr. 13, 2011, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 61/323,796, filed Apr. 13, 2010, U.S. Provisional Patent Application No. 61/323,801, filed Apr. 13, 2010, and U.S. Provisional Patent Application No. 61/323,816, filed Apr. 13, 2010, the disclosures of each of which are hereby incorporated by reference in their entirety.
Number | Name | Date | Kind |
---|---|---|---|
3496932 | Prisk et al. | Feb 1970 | A |
3677597 | Stipek | Jul 1972 | A |
3802074 | Hoppe | Apr 1974 | A |
3841685 | Kolodziej | Oct 1974 | A |
3999555 | Person | Dec 1976 | A |
4018229 | Komiya | Apr 1977 | A |
4030509 | Heilman et al. | Jun 1977 | A |
4078305 | Akiyama | Mar 1978 | A |
4181123 | Crosby | Jan 1980 | A |
4249536 | Vega | Feb 1981 | A |
4257278 | Papadofrangakis et al. | Mar 1981 | A |
4319562 | Crosby | Mar 1982 | A |
4428375 | Ellman | Jan 1984 | A |
4596530 | McGlinn | Jun 1986 | A |
4662377 | Heilman et al. | May 1987 | A |
4765341 | Mower et al. | Aug 1988 | A |
4817608 | Shapland et al. | Apr 1989 | A |
4901405 | Grover et al. | Feb 1990 | A |
4944753 | Burgess et al. | Jul 1990 | A |
4991578 | Cohen | Feb 1991 | A |
4991603 | Cohen et al. | Feb 1991 | A |
4998975 | Cohen et al. | Mar 1991 | A |
5033477 | Chin et al. | Jul 1991 | A |
5108406 | Lee | Apr 1992 | A |
5163942 | Rydell | Nov 1992 | A |
5163946 | Li | Nov 1992 | A |
5176691 | Pierce | Jan 1993 | A |
5181123 | Swank | Jan 1993 | A |
5181919 | Bergman et al. | Jan 1993 | A |
5226535 | Roshdy et al. | Jul 1993 | A |
5226908 | Yoon | Jul 1993 | A |
5242459 | Buelna | Sep 1993 | A |
5243977 | Trabucco et al. | Sep 1993 | A |
5269326 | Verrier | Dec 1993 | A |
5279539 | Bohan et al. | Jan 1994 | A |
5281238 | Chin et al. | Jan 1994 | A |
5300078 | Buelna | Apr 1994 | A |
5306234 | Johnson | Apr 1994 | A |
5318578 | Hasson | Jun 1994 | A |
5336229 | Noda | Aug 1994 | A |
5336231 | Adair | Aug 1994 | A |
5336252 | Cohen | Aug 1994 | A |
5385156 | Oliva | Jan 1995 | A |
5387219 | Rappe | Feb 1995 | A |
5398944 | Holster | Mar 1995 | A |
5403331 | Chesterfield et al. | Apr 1995 | A |
5405351 | Kinet et al. | Apr 1995 | A |
5417684 | Jackson et al. | May 1995 | A |
5423821 | Pasque | Jun 1995 | A |
5423830 | Schneebaum et al. | Jun 1995 | A |
5433457 | Wright | Jul 1995 | A |
5433730 | Alt | Jul 1995 | A |
5443481 | Lee | Aug 1995 | A |
5449361 | Preissman | Sep 1995 | A |
5449637 | Kadry | Sep 1995 | A |
5458597 | Edwards et al. | Oct 1995 | A |
5465731 | Bell et al. | Nov 1995 | A |
5494240 | Waugh | Feb 1996 | A |
5498228 | Royalty et al. | Mar 1996 | A |
5522819 | Graves et al. | Jun 1996 | A |
5540711 | Kieturakis et al. | Jul 1996 | A |
5545178 | Kensey et al. | Aug 1996 | A |
5571161 | Starksen | Nov 1996 | A |
5591177 | Lehrer | Jan 1997 | A |
5609597 | Lehrer | Mar 1997 | A |
5624430 | Eton et al. | Apr 1997 | A |
5624453 | Ahmed | Apr 1997 | A |
5634895 | Igo et al. | Jun 1997 | A |
5636780 | Green et al. | Jun 1997 | A |
5676162 | Larson, Jr. et al. | Oct 1997 | A |
5676651 | Larson, Jr. et al. | Oct 1997 | A |
5678547 | Faupel et al. | Oct 1997 | A |
5681278 | Igo et al. | Oct 1997 | A |
5682906 | Sterman et al. | Nov 1997 | A |
5683348 | Diener | Nov 1997 | A |
5683364 | Zadini et al. | Nov 1997 | A |
5683445 | Swoyer | Nov 1997 | A |
5693059 | Yoon | Dec 1997 | A |
5693091 | Larson, Jr. et al. | Dec 1997 | A |
5699748 | Linskey, Jr. et al. | Dec 1997 | A |
5702430 | Larson, Jr. et al. | Dec 1997 | A |
5707336 | Rubin | Jan 1998 | A |
5716367 | Koike et al. | Feb 1998 | A |
5716392 | Bourgeois et al. | Feb 1998 | A |
5727569 | Benetti et al. | Mar 1998 | A |
5728151 | Garrison et al. | Mar 1998 | A |
5735877 | Pagedas | Apr 1998 | A |
5741281 | Martin | Apr 1998 | A |
5752526 | Cosgrove | May 1998 | A |
5766151 | Valley et al. | Jun 1998 | A |
5766216 | Gangal et al. | Jun 1998 | A |
5766217 | Christy | Jun 1998 | A |
5769863 | Garrison | Jun 1998 | A |
5779727 | Orejola | Jul 1998 | A |
5788715 | Watson, Jr. et al. | Aug 1998 | A |
5792151 | Heck et al. | Aug 1998 | A |
5797870 | March et al. | Aug 1998 | A |
5797929 | Andreas et al. | Aug 1998 | A |
5797946 | Chin | Aug 1998 | A |
5799661 | Boyd et al. | Sep 1998 | A |
5810845 | Yoon | Sep 1998 | A |
5814052 | Nakao et al. | Sep 1998 | A |
5823946 | Chin | Oct 1998 | A |
5827216 | Igo et al. | Oct 1998 | A |
5840059 | March et al. | Nov 1998 | A |
5855586 | Habara et al. | Jan 1999 | A |
5865791 | Whayne et al. | Feb 1999 | A |
5871531 | Struble | Feb 1999 | A |
5873876 | Christy | Feb 1999 | A |
5879375 | Larson, Jr. et al. | Mar 1999 | A |
5882299 | Rastegar et al. | Mar 1999 | A |
5893869 | Barnhart et al. | Apr 1999 | A |
5895298 | Faupel et al. | Apr 1999 | A |
5895404 | Ruiz | Apr 1999 | A |
5897586 | Molina | Apr 1999 | A |
5900433 | Igo et al. | May 1999 | A |
5906579 | Vander Salm et al. | May 1999 | A |
5906620 | Nakao et al. | May 1999 | A |
5908429 | Yoon | Jun 1999 | A |
5908435 | Samuels | Jun 1999 | A |
5910124 | Rubin | Jun 1999 | A |
5910129 | Koblish et al. | Jun 1999 | A |
5921994 | Andreas et al. | Jul 1999 | A |
5924424 | Stevens et al. | Jul 1999 | A |
RE36269 | Wright | Aug 1999 | E |
5941819 | Chin | Aug 1999 | A |
5957936 | Yoon et al. | Sep 1999 | A |
5961440 | Schweich, Jr. et al. | Oct 1999 | A |
5964699 | Rullo et al. | Oct 1999 | A |
5968010 | Waxman et al. | Oct 1999 | A |
5972013 | Schmidt | Oct 1999 | A |
5984866 | Rullo et al. | Nov 1999 | A |
5984917 | Fleischman et al. | Nov 1999 | A |
5991668 | Leinders et al. | Nov 1999 | A |
5997525 | March et al. | Dec 1999 | A |
6006122 | Smits | Dec 1999 | A |
6010531 | Donlon et al. | Jan 2000 | A |
6015382 | Zwart et al. | Jan 2000 | A |
6027499 | Johnston et al. | Feb 2000 | A |
6045570 | Epstein et al. | Apr 2000 | A |
6048329 | Thompson et al. | Apr 2000 | A |
6059750 | Fogarty et al. | May 2000 | A |
6067942 | Fernandez | May 2000 | A |
6071281 | Burnside et al. | Jun 2000 | A |
6081738 | Hinohara et al. | Jun 2000 | A |
6083153 | Rullo et al. | Jul 2000 | A |
6090042 | Rullo et al. | Jul 2000 | A |
6095968 | Snyders | Aug 2000 | A |
6110170 | Taylor et al. | Aug 2000 | A |
6120431 | Magovern et al. | Sep 2000 | A |
6132438 | Fleischman et al. | Oct 2000 | A |
6148230 | KenKnight | Nov 2000 | A |
6149595 | Seitz et al. | Nov 2000 | A |
6152144 | Lesh et al. | Nov 2000 | A |
6152920 | Thompson et al. | Nov 2000 | A |
6152936 | Christy et al. | Nov 2000 | A |
6155968 | Wilk | Dec 2000 | A |
6157852 | Selmon et al. | Dec 2000 | A |
6161543 | Cox et al. | Dec 2000 | A |
6162195 | Igo et al. | Dec 2000 | A |
6167889 | Benetti | Jan 2001 | B1 |
6199556 | Benetti et al. | Mar 2001 | B1 |
6200303 | Verrior et al. | Mar 2001 | B1 |
6206004 | Schmidt et al. | Mar 2001 | B1 |
6224584 | March et al. | May 2001 | B1 |
6231518 | Grabek et al. | May 2001 | B1 |
6237605 | Vaska et al. | May 2001 | B1 |
6241667 | Vetter et al. | Jun 2001 | B1 |
6258021 | Wilk | Jul 2001 | B1 |
6266550 | Selmon et al. | Jul 2001 | B1 |
6280415 | Johnson | Aug 2001 | B1 |
6283127 | Sterman et al. | Sep 2001 | B1 |
6290674 | Roue et al. | Sep 2001 | B1 |
6293906 | Vanden Hoek et al. | Sep 2001 | B1 |
6296630 | Altman et al. | Oct 2001 | B1 |
6311692 | Vaska et al. | Nov 2001 | B1 |
6311693 | Sterman et al. | Nov 2001 | B1 |
6314962 | Vaska et al. | Nov 2001 | B1 |
6314963 | Vaska et al. | Nov 2001 | B1 |
6319201 | Wilk | Nov 2001 | B1 |
6333347 | Hunter et al. | Dec 2001 | B1 |
6346074 | Roth | Feb 2002 | B1 |
6379366 | Fleischman et al. | Apr 2002 | B1 |
6423051 | Kaplan et al. | Jul 2002 | B1 |
6474340 | Vaska et al. | Nov 2002 | B1 |
6485407 | Alferness et al. | Nov 2002 | B2 |
6488689 | Kaplan et al. | Dec 2002 | B1 |
6494211 | Boyd et al. | Dec 2002 | B1 |
6551303 | Van Tassel et al. | Apr 2003 | B1 |
6561969 | Frazier et al. | May 2003 | B2 |
6592552 | Schmidt | Jul 2003 | B1 |
6610055 | Swanson et al. | Aug 2003 | B1 |
6610072 | Christy et al. | Aug 2003 | B1 |
6613062 | Leckrone et al. | Sep 2003 | B1 |
6632229 | Yamanouchi | Oct 2003 | B1 |
6652555 | VanTassel et al. | Nov 2003 | B1 |
6656175 | Francischelli et al. | Dec 2003 | B2 |
6666861 | Grabek | Dec 2003 | B1 |
6692491 | Phan | Feb 2004 | B1 |
6733509 | Nobles et al. | May 2004 | B2 |
6736774 | Benetti et al. | May 2004 | B2 |
6755338 | Hahnen et al. | Jun 2004 | B2 |
6786898 | Guenst | Sep 2004 | B2 |
6789509 | Motsinger | Sep 2004 | B1 |
6830174 | Hillstead et al. | Dec 2004 | B2 |
6830576 | Fleischman et al. | Dec 2004 | B2 |
6840246 | Downing | Jan 2005 | B2 |
6985776 | Kane et al. | Jan 2006 | B2 |
7011671 | Welch | Mar 2006 | B2 |
7041111 | Chu | May 2006 | B2 |
7056294 | Khairkhahan et al. | Jun 2006 | B2 |
7063682 | Whayne et al. | Jun 2006 | B1 |
7063693 | Guenst | Jun 2006 | B2 |
7175619 | Koblish et al. | Feb 2007 | B2 |
7186214 | Ness | Mar 2007 | B2 |
7207988 | Leckrone et al. | Apr 2007 | B2 |
7226440 | Gelfand et al. | Jun 2007 | B2 |
7226458 | Kaplan et al. | Jun 2007 | B2 |
7264587 | Chin | Sep 2007 | B2 |
7294115 | Wilk | Nov 2007 | B1 |
7297144 | Fleischman et al. | Nov 2007 | B2 |
7309328 | Kaplan et al. | Dec 2007 | B2 |
7318829 | Kaplan et al. | Jan 2008 | B2 |
7326221 | Sakamoto et al. | Feb 2008 | B2 |
7331979 | Khosravi et al. | Feb 2008 | B2 |
7473260 | Opolski et al. | Jan 2009 | B2 |
7597705 | Forsberg et al. | Oct 2009 | B2 |
7608091 | Goldfarb et al. | Oct 2009 | B2 |
7610104 | Kaplan et al. | Oct 2009 | B2 |
7618425 | Yamamoto et al. | Nov 2009 | B2 |
7681579 | Schwartz | Mar 2010 | B2 |
7722641 | van der Burg et al. | May 2010 | B2 |
7736347 | Kaplan et al. | Jun 2010 | B2 |
7828810 | Liddicoat et al. | Nov 2010 | B2 |
7846168 | Liddicoat et al. | Dec 2010 | B2 |
7905900 | Palermo et al. | Mar 2011 | B2 |
7918865 | Liddicoat et al. | Apr 2011 | B2 |
7967808 | Fitzgerald et al. | Jun 2011 | B2 |
8070693 | Ayala et al. | Dec 2011 | B2 |
8105342 | Onuki et al. | Jan 2012 | B2 |
8157818 | Gartner et al. | Apr 2012 | B2 |
8287561 | Nunez et al. | Oct 2012 | B2 |
8469983 | Fung et al. | Jun 2013 | B2 |
8500768 | Cohen | Aug 2013 | B2 |
8636767 | McClain | Jan 2014 | B2 |
8715302 | Ibrahim et al. | May 2014 | B2 |
8721663 | Kaplan et al. | May 2014 | B2 |
8771297 | Miller et al. | Jul 2014 | B2 |
8795297 | Liddicoat et al. | Aug 2014 | B2 |
8795310 | Fung et al. | Aug 2014 | B2 |
8814778 | Kiser et al. | Aug 2014 | B2 |
8932276 | Morriss et al. | Jan 2015 | B1 |
8961543 | Friedman et al. | Feb 2015 | B2 |
8974473 | Kaplan et al. | Mar 2015 | B2 |
8986278 | Fung et al. | Mar 2015 | B2 |
8986325 | Miller et al. | Mar 2015 | B2 |
8996133 | Kaplan et al. | Mar 2015 | B2 |
9089324 | McCaw et al. | Jul 2015 | B2 |
9186174 | Krishnan et al. | Nov 2015 | B2 |
9198664 | Fung et al. | Dec 2015 | B2 |
9198683 | Friedman et al. | Dec 2015 | B2 |
9271819 | Liddicoat et al. | Mar 2016 | B2 |
9339295 | Fung et al. | May 2016 | B2 |
9408608 | Clark et al. | Aug 2016 | B2 |
9498223 | Miller et al. | Nov 2016 | B2 |
9956036 | Whayne et al. | May 2018 | B2 |
10136909 | Ibrahim et al. | Nov 2018 | B2 |
20010003795 | Suresh et al. | Jun 2001 | A1 |
20010007070 | Stewart et al. | Jul 2001 | A1 |
20010025132 | Alferness et al. | Sep 2001 | A1 |
20020002329 | Avitall | Jan 2002 | A1 |
20020017306 | Cox et al. | Feb 2002 | A1 |
20020022860 | Borillo et al. | Feb 2002 | A1 |
20020032440 | Hooven | Mar 2002 | A1 |
20020045895 | Sliwa, Jr. et al. | Apr 2002 | A1 |
20020049457 | Kaplan et al. | Apr 2002 | A1 |
20020058925 | Kaplan et al. | May 2002 | A1 |
20020062136 | Hillstead et al. | May 2002 | A1 |
20020068970 | Cox et al. | Jun 2002 | A1 |
20020099390 | Kaplan et al. | Jul 2002 | A1 |
20020103492 | Kaplan et al. | Aug 2002 | A1 |
20020107531 | Schreck et al. | Aug 2002 | A1 |
20020111636 | Fleischman et al. | Aug 2002 | A1 |
20020111637 | Kaplan et al. | Aug 2002 | A1 |
20020123771 | Ideker et al. | Sep 2002 | A1 |
20020128639 | Pless et al. | Sep 2002 | A1 |
20020147456 | Diduch et al. | Oct 2002 | A1 |
20030014049 | Koblish et al. | Jan 2003 | A1 |
20030024537 | Cox et al. | Feb 2003 | A1 |
20030045900 | Hahnen et al. | Mar 2003 | A1 |
20030069577 | Vaska et al. | Apr 2003 | A1 |
20030078465 | Pai et al. | Apr 2003 | A1 |
20030083542 | Alferness et al. | May 2003 | A1 |
20030083674 | Gibbens, III | May 2003 | A1 |
20030109863 | Francischelli et al. | Jun 2003 | A1 |
20030120264 | Lattouf | Jun 2003 | A1 |
20030120337 | Van Tassel et al. | Jun 2003 | A1 |
20030158464 | Bertolero | Aug 2003 | A1 |
20030181942 | Sutton et al. | Sep 2003 | A1 |
20030187460 | Chin et al. | Oct 2003 | A1 |
20030220667 | Van der Burg et al. | Nov 2003 | A1 |
20030236535 | Onuki et al. | Dec 2003 | A1 |
20040024414 | Downing | Feb 2004 | A1 |
20040030335 | Zenati et al. | Feb 2004 | A1 |
20040034347 | Hall et al. | Feb 2004 | A1 |
20040044361 | Frazier et al. | Mar 2004 | A1 |
20040049210 | VanTassel et al. | Mar 2004 | A1 |
20040059280 | Makower et al. | Mar 2004 | A1 |
20040059352 | Burbank et al. | Mar 2004 | A1 |
20040064138 | Grabek | Apr 2004 | A1 |
20040068267 | Harvie et al. | Apr 2004 | A1 |
20040078069 | Francischelli et al. | Apr 2004 | A1 |
20040102804 | Chin | May 2004 | A1 |
20040106918 | Cox et al. | Jun 2004 | A1 |
20040111101 | Chin | Jun 2004 | A1 |
20040116943 | Brandt et al. | Jun 2004 | A1 |
20040122467 | Van Tassel et al. | Jun 2004 | A1 |
20040148020 | Vidlund et al. | Jul 2004 | A1 |
20040158127 | Okada | Aug 2004 | A1 |
20040162579 | Foerster | Aug 2004 | A1 |
20040225212 | Okerlund et al. | Nov 2004 | A1 |
20040225300 | Goldfarb et al. | Nov 2004 | A1 |
20040243176 | Hahnen et al. | Dec 2004 | A1 |
20040260273 | Wan | Dec 2004 | A1 |
20050033274 | Pless et al. | Feb 2005 | A1 |
20050033280 | Francischelli et al. | Feb 2005 | A1 |
20050033287 | Sra | Feb 2005 | A1 |
20050033321 | Fleischman et al. | Feb 2005 | A1 |
20050043743 | Dennis | Feb 2005 | A1 |
20050043745 | Alferness et al. | Feb 2005 | A1 |
20050080454 | Drews et al. | Apr 2005 | A1 |
20050085843 | Opolski et al. | Apr 2005 | A1 |
20050101984 | Chanduszko et al. | May 2005 | A1 |
20050107824 | Hillstead et al. | May 2005 | A1 |
20050113861 | Corcoran et al. | May 2005 | A1 |
20050149068 | Williams et al. | Jul 2005 | A1 |
20050149069 | Bertolero et al. | Jul 2005 | A1 |
20050154376 | Riviere et al. | Jul 2005 | A1 |
20050165466 | Morris et al. | Jul 2005 | A1 |
20050187545 | Hooven et al. | Aug 2005 | A1 |
20050228422 | Machold et al. | Oct 2005 | A1 |
20050256532 | Nayak et al. | Nov 2005 | A1 |
20060004323 | Chang et al. | Jan 2006 | A1 |
20060004388 | Whayne et al. | Jan 2006 | A1 |
20060009715 | Khairkhahan et al. | Jan 2006 | A1 |
20060009756 | Francischelli et al. | Jan 2006 | A1 |
20060020162 | Whayne et al. | Jan 2006 | A1 |
20060020271 | Stewart et al. | Jan 2006 | A1 |
20060020336 | Liddicoat | Jan 2006 | A1 |
20060034930 | Khosravi et al. | Feb 2006 | A1 |
20060095066 | Chang et al. | May 2006 | A1 |
20060100545 | Ayala et al. | May 2006 | A1 |
20060106278 | Machold et al. | May 2006 | A1 |
20060200120 | DiCarlo et al. | Sep 2006 | A1 |
20060200169 | Sniffin | Sep 2006 | A1 |
20060212045 | Schilling et al. | Sep 2006 | A1 |
20060247672 | Vidlund et al. | Nov 2006 | A1 |
20060253128 | Sekine et al. | Nov 2006 | A1 |
20070010829 | Nobles et al. | Jan 2007 | A1 |
20070016228 | Salas | Jan 2007 | A1 |
20070027456 | Gartner et al. | Feb 2007 | A1 |
20070038229 | de la Torre | Feb 2007 | A1 |
20070043344 | McAuley | Feb 2007 | A1 |
20070060951 | Shannon | Mar 2007 | A1 |
20070083082 | Kiser et al. | Apr 2007 | A1 |
20070083194 | Kunis et al. | Apr 2007 | A1 |
20070083225 | Kiser et al. | Apr 2007 | A1 |
20070083230 | Javois | Apr 2007 | A1 |
20070083232 | Lee | Apr 2007 | A1 |
20070088369 | Shaw et al. | Apr 2007 | A1 |
20070100405 | Thompson et al. | May 2007 | A1 |
20070135822 | Onuki et al. | Jun 2007 | A1 |
20070149988 | Michler et al. | Jun 2007 | A1 |
20070179345 | Santilli | Aug 2007 | A1 |
20070203554 | Kaplan et al. | Aug 2007 | A1 |
20070219546 | Mody et al. | Sep 2007 | A1 |
20070249991 | Whayne et al. | Oct 2007 | A1 |
20070260278 | Wheeler et al. | Nov 2007 | A1 |
20070270637 | Takemoto et al. | Nov 2007 | A1 |
20070270891 | McGuckin, Jr. | Nov 2007 | A1 |
20080009843 | de la Torre | Jan 2008 | A1 |
20080015406 | Dlugos et al. | Jan 2008 | A1 |
20080015571 | Rubinsky | Jan 2008 | A1 |
20080033241 | Peh et al. | Feb 2008 | A1 |
20080033457 | Francischelli et al. | Feb 2008 | A1 |
20080039879 | Chin et al. | Feb 2008 | A1 |
20080058635 | Halperin et al. | Mar 2008 | A1 |
20080065156 | Hauser et al. | Mar 2008 | A1 |
20080097489 | Goldfarb et al. | Apr 2008 | A1 |
20080125795 | Kaplan et al. | May 2008 | A1 |
20080154260 | Hoof | Jun 2008 | A1 |
20080177381 | Navia et al. | Jul 2008 | A1 |
20080214889 | Saadat et al. | Sep 2008 | A1 |
20080221593 | Liddicoat et al. | Sep 2008 | A1 |
20080228265 | Spence et al. | Sep 2008 | A1 |
20080243183 | Miller | Oct 2008 | A1 |
20080245371 | Gruber | Oct 2008 | A1 |
20080269782 | Stefanchik et al. | Oct 2008 | A1 |
20080294174 | Bardsley et al. | Nov 2008 | A1 |
20080294175 | Bardsley et al. | Nov 2008 | A1 |
20080312664 | Bardsley et al. | Dec 2008 | A1 |
20090043317 | Cavanaugh et al. | Feb 2009 | A1 |
20090088728 | Dollar et al. | Apr 2009 | A1 |
20090088778 | Miyamoto et al. | Apr 2009 | A1 |
20090093809 | Anderson et al. | Apr 2009 | A1 |
20090124847 | Doty et al. | May 2009 | A1 |
20090143791 | Miller et al. | Jun 2009 | A1 |
20090157118 | Miller et al. | Jun 2009 | A1 |
20090182326 | Zenati et al. | Jul 2009 | A1 |
20090196696 | Otsuka et al. | Aug 2009 | A1 |
20100069925 | Friedman et al. | Mar 2010 | A1 |
20100094314 | Hernlund | Apr 2010 | A1 |
20100174296 | Vakharia et al. | Jul 2010 | A1 |
20100191253 | Oostman et al. | Jul 2010 | A1 |
20100331820 | Giuseppe et al. | Dec 2010 | A1 |
20110034804 | Hubregtse et al. | Feb 2011 | A1 |
20110060350 | Powers et al. | Mar 2011 | A1 |
20110087270 | Penner et al. | Apr 2011 | A1 |
20110092997 | Kang | Apr 2011 | A1 |
20110106107 | Binmoeller et al. | May 2011 | A1 |
20110112537 | Bernstein et al. | May 2011 | A1 |
20110144660 | Liddicoat et al. | Jun 2011 | A1 |
20110282250 | Fung et al. | Nov 2011 | A1 |
20110295060 | Zenati et al. | Dec 2011 | A1 |
20120022558 | Friedman et al. | Jan 2012 | A1 |
20120095434 | Fung et al. | Apr 2012 | A1 |
20120158022 | Kaplan et al. | Jun 2012 | A1 |
20120209300 | Torrie | Aug 2012 | A1 |
20120330351 | Friedman et al. | Dec 2012 | A1 |
20130144311 | Fung et al. | Jun 2013 | A1 |
20130218156 | Kassab et al. | Aug 2013 | A1 |
20130296880 | Kelley et al. | Nov 2013 | A1 |
20140018831 | Kassab et al. | Jan 2014 | A1 |
20140171733 | Sternik | Jun 2014 | A1 |
20140222138 | Machold et al. | Aug 2014 | A1 |
20140276911 | Smith et al. | Sep 2014 | A1 |
20140303721 | Fung et al. | Oct 2014 | A1 |
20140316385 | Longoria et al. | Oct 2014 | A1 |
20140330074 | Morriss et al. | Nov 2014 | A1 |
20140336572 | Heisel et al. | Nov 2014 | A1 |
20140336676 | Pong et al. | Nov 2014 | A1 |
20140364901 | Kiser et al. | Dec 2014 | A1 |
20140364907 | White et al. | Dec 2014 | A1 |
20140371741 | Longoria et al. | Dec 2014 | A1 |
20150018853 | Friedman et al. | Jan 2015 | A1 |
20150025312 | de Canniere | Jan 2015 | A1 |
20150173765 | Friedman et al. | Jan 2015 | A1 |
20150119884 | Fung et al. | Apr 2015 | A1 |
20150157328 | Miller et al. | Jun 2015 | A1 |
20150182225 | Morejohn et al. | Jul 2015 | A1 |
20150190135 | Ibrahim et al. | Jul 2015 | A1 |
20150223813 | Willisamson et al. | Aug 2015 | A1 |
20150250482 | Slaughter et al. | Sep 2015 | A1 |
20150272618 | Fung et al. | Oct 2015 | A1 |
20150374380 | Miller et al. | Dec 2015 | A1 |
20160008001 | Winkler et al. | Jan 2016 | A1 |
20160106421 | Eliachar et al. | Apr 2016 | A1 |
20160120549 | Fung et al. | May 2016 | A1 |
20160278781 | Fung et al. | Sep 2016 | A1 |
20160302793 | Fung et al. | Oct 2016 | A1 |
20160310144 | Kimura et al. | Oct 2016 | A1 |
20160310145 | Clark et al. | Oct 2016 | A1 |
20160317155 | Kimura et al. | Nov 2016 | A1 |
20160346028 | Rogers et al. | Dec 2016 | A1 |
20170290592 | Miller et al. | Oct 2017 | A1 |
20180008342 | Ibrahim et al. | Jan 2018 | A1 |
Number | Date | Country |
---|---|---|
2624615 | Jul 2004 | CN |
101242785 | Aug 2008 | CN |
101262823 | Dec 2011 | CN |
0 598 219 | May 1994 | EP |
0 598 219 | May 1994 | EP |
0 598 219 | May 1994 | EP |
0 625 336 | Nov 1994 | EP |
0 705 566 | Apr 1996 | EP |
1 010 397 | Jun 2000 | EP |
1 506 142 | Apr 1978 | GB |
H-6-319742 | Nov 1994 | JP |
7-296645 | Nov 1995 | JP |
7-299073 | Nov 1995 | JP |
11-507262 | Jun 1999 | JP |
2001-120560 | May 2001 | JP |
2002-512071 | Apr 2002 | JP |
2002-540834 | Dec 2002 | JP |
2002-540901 | Dec 2002 | JP |
2003-225241 | Aug 2003 | JP |
2004-000601 | Jan 2004 | JP |
2005-110860 | Apr 2005 | JP |
2005-296645 | Oct 2005 | JP |
2005-531360 | Oct 2005 | JP |
2007-504886 | Mar 2007 | JP |
2007-534355 | Nov 2007 | JP |
2008-534085 | Aug 2008 | JP |
2010-523171 | Jul 2010 | JP |
2012-522596 | Sep 2012 | JP |
WO-9401045 | Jan 1994 | WO |
WO-9404079 | Mar 1994 | WO |
WO-9408514 | Apr 1994 | WO |
WO-9604854 | Feb 1996 | WO |
WO-9640356 | Dec 1996 | WO |
WO-9711644 | Apr 1997 | WO |
WO-9743957 | Nov 1997 | WO |
WO-9953845 | Oct 1999 | WO |
WO-0059383 | Oct 2000 | WO |
WO-0061202 | Oct 2000 | WO |
WO-03028558 | Apr 2003 | WO |
WO-2004002327 | Jan 2004 | WO |
WO-2004066828 | Aug 2004 | WO |
WO-2004066828 | Aug 2004 | WO |
WO-2005034767 | Apr 2005 | WO |
WO-2005034802 | Apr 2005 | WO |
WO-2005034802 | Apr 2005 | WO |
WO-2006096805 | Sep 2006 | WO |
WO-2006110734 | Oct 2006 | WO |
WO-2006115689 | Nov 2006 | WO |
WO-2007001936 | Jan 2007 | WO |
WO-2007001936 | Jan 2007 | WO |
WO-2007037516 | Apr 2007 | WO |
WO-2007037516 | Apr 2007 | WO |
WO-2007056502 | May 2007 | WO |
WO-2008017080 | Feb 2008 | WO |
WO-2008017080 | Feb 2008 | WO |
WO-2008036408 | Mar 2008 | WO |
WO-2008036408 | Mar 2008 | WO |
WO-2008091612 | Jul 2008 | WO |
WO-2008091612 | Jul 2008 | WO |
WO-2008121278 | Oct 2008 | WO |
WO-2008150346 | Dec 2008 | WO |
WO-2009039191 | Mar 2009 | WO |
WO-2009045265 | Apr 2009 | WO |
WO-2009094237 | Jul 2009 | WO |
WO-2010006061 | Jan 2010 | WO |
WO-2010006061 | Jan 2010 | WO |
WO-2010007600 | Jan 2010 | WO |
WO-2010048141 | Apr 2010 | WO |
WO-2010048141 | Apr 2010 | WO |
WO-2010115030 | Oct 2010 | WO |
WO-2011129893 | Oct 2011 | WO |
WO-2012170652 | Dec 2012 | WO |
WO-2014164028 | Oct 2014 | WO |
Entry |
---|
Extended European Search Report dated Jul. 10, 2015, for European Patent Application No. 15153029.2, filed on Mar. 25, 2008, 6 pages. |
Extended European Search Report dated Feb. 10, 2017, for EP Application No. 10 759 425.1, filed on Apr. 1, 2010, 7 pages. |
Extended European Search Report dated Oct. 30, 2017, for EP Application No. 11 769 217.8, filed on Apr. 13, 2011, 12 pages. |
Extended European Search Report dated Oct. 30, 2017, for EP Application No. 11 769 218.6, filed on Apr. 13, 2011, 11 pages. |
International Search Report dated Feb. 27, 2007, for PCT Application No. PCT/US2008/003938, filed on Mar. 25, 2008, 5 pages. |
International Search Report dated Jun. 1, 2010, for PCT Application No. PCT/US2010/029668, filed on Apr. 1, 2010, 2 pages. |
International Search Report dated Oct. 3, 2011, for PCT Patent Application No. PCT/US2011/00677, filed on Apr. 13, 2011, 5 pages. |
Written Opinion of the International Searching Authority dated Feb. 27, 2007, for PCT Application No. PCT/US2008/003938, filed on Mar. 25, 2008, 10 pages. |
Written Opinion of the International Searching Authority dated Jun. 1, 2010, for PCT Application No. PCT/US2010/029668, filed on Apr. 1, 2010, 8 pages. |
Written Opinion of the International Search Authority dated Oct. 3, 2011, for PCT Application No. PCT/US2011/00677, filed on Apr. 13, 2011, 6 pages. |
Final Office Action dated Jun. 8, 2017, for U.S. Appl. No. 14/625,540, filed Feb. 18, 2015, 14 pages. |
Final Office Action dated Mar. 17, 2016, for U.S. Appl. No. 12/363,359, filed Jan. 30, 2009, 10 pages. |
Non-Final Office Action dated Mar. 29, 2013, for U.S. Appl. No. 12/752,873, filed Apr. 1, 2010, 16 pages. |
Non-Final Office Action dated Dec. 2, 2016, for U.S. Appl. No. 14/625,540, filed Feb. 18, 2015, 20 pages. |
afibfacts.com (Date Unknown). “Cox-Maze III: The Gold Standard Treatment for Atrial Fibrillation: Developing a Surgical Option for Atrial Fibrillation,” located at <http://www.afibfacts.com/Treatment_Options_for_Atrial_Fibrillation/Cox-Maze_III%_3a_The_Gold_Standard_Treatment_for_Atrial_Fibrillation >, last visited on Apr. 20, 2007, 4 pages. |
Al-Saady, N.M. et al. (1999). “Left Atrial Appendage: Structure, Function, and Role in Thromboembolism,” Heart 82:547-554. |
Albers, G.W. (Jul. 11, 1994). “Atrial Fibrillation and Stroke: Three New Studies, Three Remaining Questions,” Arch Intern Med 154:1443-1448. |
Alonso, M. et al. (Mar. 4, 2003). “Complications With Femoral Access in Cardiac Catheterization. Impact of Previous Systematic Femoral Angiography and Hemostasis With VasoSeal-Es® Collagen Plug,” Rev. Esp. Cardiol. 56(6):569-577. |
Aronow, W.S. et al. (Apr. 2009). “Atrial Fibrillation: The New Epidemic of the Age-ing World,” Journal of Atrial Fibrillation 1(6):337-361. |
Australian Office Action dated Dec. 19, 2014, for Australian Patent Application No. 2011241103, filed on Apr. 13, 2011, 4 pages. |
Babaliaros, V.C. et al. (Jun. 3, 2008). “Emerging Applications for Transseptal Left Heart Catheterization: Old Techniques for New Procedures,” Journal of the American College of Cardiology 51(22):2116-2122. |
Bath, P.M.W. et al. (2005). “Current Status of Stroke Prevention in Patients with Atrial Fibrillation,” European Heart Journal Supplements 7(Supplement C):C12-C18. |
Benjamin, B.A. et al. (1994). “Effect of Bilateral Atrial Appendectomy on Postprandial Sodium Excretion in Conscious Monkeys,” Society for Experimental Biology and Medicine 206: 1 page. |
Beygui, F. et al. (2005, e-pub. Oct. 21, 2005). “Multimodality Imaging of Percutaneous Closure of the Left Atrial Appendage,” Clinical Vignette, 1 page. |
Bisleri, G. et al. (Jun. 3, 2005). “Innovative Monolateral Approach for Closed-Chest Atrial Fibrillation Surgery,” The Annals of Thoracic Surgery 80:e22-e25. |
Björk, V.O. et al. (Aug. 1961). “Sequelae of Left Ventricular Puncture with Angiocardiography,” Circulation 24:204-212. |
Blackshear, J.L. et al. (Feb. 1996). “Appendage Obliteration to Reduce Stroke in Cardiac Surgical Patients With Atrial Fibrillation,” Ann. Thorac. Surg. 61(2), 13 pages. |
Blackshear, J.L. et al. (Oct. 1, 2003). “Thorascopic Extracardiac Obliteration of the Left Atrial Appendage for Stroke Risk Reduction in Atrial Fibrillation,” J. Am. Coll. Cardiol. 42(7):1249-1252. |
Bonanomi, G. et al. (Jan. 1, 2003). “Left Atrial Appendectomy and Maze,” Journal of the American College of Cardiology 41(1):169-171. |
Bonow, R.O. et al. (1998). “Guidelines for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients With Valvular Heart Disease),” Circulation 98:1949-1984. |
Botham, R.J. et al. (May 1959). “Pericardial Tamponade Following Percutaneous Left Ventricular Puncture,” Circulation 19:741-744. |
Brock, R. et al. (1956). “Percutaneous Left Ventricular Puncture in the Assessment of Aortic Stenosis,” Thorax 11:163-171. |
Burke, R.P. et al. (1992). “Improved Surgical Approach to Left Atrial Appendage Aneurysm,” Journal of Cardiac Surgery 7(2):104-107. |
Canaccord Adams. (Aug. 11, 2008). “A-Fib: Near a Tipping Point,” 167 pages. |
Chung, M.K. (Jul. 2003). “Current Clinical Issues in Atrial Fibrillation,” Cleveland Clinic Journal of Medicine 70(Supp. 3):S6-S11. |
Coffin, L.H. (Jun. 1985). “Use of the Surgical Stapler to Obliterate the Left Atrial Appendage,” Surgery, Gynecology & Obstetric 160:565-566. |
Connolly, S.J. (Sep. 7, 1999). “Preventing Stroke in Atrial Fibrillation: Why Are So Many Eligible Patients Not Receiving Anticoagulant Therapy?” Canadian Medical Association 161(5):533-534. |
Costa, R. et al. (2006). “Bi-Atrial Subxiphoid Epicardial Pacemaker in Superior Vena Cava Syndrome,” Arq. Bras. Cardiol. 87:e45-e47. |
Cox, J.L. et al. (Apr. 1991). “The Surgical Treatment of Atrial Fibrillation: IV. Surgical Technique,” J. Thorac. Cardiovasc. Surg. 101(4):584-592. |
Cox, J.L. et al. (Aug. 1995). “Modification of the Maze Procedure for Atrial Flutter and Atrial Fibrillation I. Rationale and Surgical Results,” J. Thorac. Cardiovasc. Surg. 110(2):473-484. |
Cox, J.L. et al. (Aug. 1995). “Modification of the Maze Procedure for Atrial Flutter and Atrial Fibrillation II. Surgical Technique of the Maze III Procedure,” J. Thorac. Cardiovasc. Surg. 110(2):485-495. |
Cox, J.L. et al. (Nov. 1999). “Impact of the Maze Procedure on the Stroke Rate in Patients with Atrial Fibrillation,” J. Thorac. Cardiovasc. Surg. 118:833-840. |
Cox, J.L. et al. (2004). “The Role of Surgical Intervention in the Management of Atrial Fibrillation,” Texas Heart Institute Journal 31(3):257-265. |
Crystal, E. et al. (Jan. 2003). “Left Atrial Appendage Occlusion Study (LAAOS): A Randomized Clinical Trial of Left Atrial Appendage Occlusion During Routine Coronary Artery Bypass Graft Surgery for Long-term Stroke Prevention,” Am Heart J 145(1):174-178. |
D'Avila, A. et al. (Apr. 2003). “Pericardial Anatomy for the Interventional Electrophysiologist,” Journal of Cardiovascular Electrophysiology 14(4):422-430. |
D'Avila, A. et al. (Nov. 2007). “Experimental Efficacy of Pericardial Instillation of Anti-inflammatory Agents During Percutaneous Epicardial Catheter Ablation to Prevent Postprocedure Pericarditis,” Journal of Cardiovascular Electrophysiology 18(11):1178-1183. |
Demaria, A.N. et al. (Dec. 17, 2003). “Highlights of the Year JACC 2003,” Journal of the American College of Cardiology 42(12):2156-2166. |
Deneu, S. et al. (Jul. 11, 1999). “Catheter Entrapment by Atrial Suture During Minimally Invasive Port-access Cardiac Surgery,” Canadian Journal of Anesthesia 46(10):983-986. |
Deponti, R. et al. (Mar. 7, 2006). “Trans-Septal Catheterization in the Electrophysiology Laboratory: Data From a Multicenter Survey Spanning 12 Years,” Journal of the American College of Cardiology 47(5):1037-1042. |
Donal, E. et al. (Sep. 2005). “The Left Atrial Appendage, a Small, Blind-Ended Structure: A Review of Its Echocardiographic Evaluation and Its Clinical Role,” Chest 128(3):1853-1862. |
Donnino, R. et al. (2007). “Left Atrial Appendage Thrombus Outside of a ‘Successful’ Ligation,” European Journal of Echocardiography pp. 1-2. |
Dullum, M.K.C. et al. (1999). “Xyphoid MIDCAB: Report of the Technique and Experience with a Less Invasive MIDCAB Procedure,” Heart Surgery Forum 2(1):77-81. |
Feinberg, W.M. et al. (Mar. 13, 1995). “Prevalence, Age Distribution, and Gender of Patients With Atrial Fibrillation,” Arch Intern Med 155:469-473. |
Fieguth, H.G. et al. (1997). “Inhibition of Atrial Fibrillation by Pulmonary Vein Isolation and Auricular Resection—Experimental Study in a Sheep Model,” European Journal of Cardio-Thoracic Surgery 11:714-721. |
Final Office Action dated Jun. 22, 2009, for U.S. Appl. No. 10/963,371, filed Oct. 11, 2004, 11 pages. |
Final Office Action dated Apr. 14, 2010, for U.S. Appl. No. 11/600,671, filed Nov. 15, 2006, 7 pages. |
Final Office Action dated Jul. 21, 2010, for U.S. Appl. No. 11/400,714, filed Apr. 7, 2006, 10 pages. |
Final Office Action dated Apr. 26, 2011, for U.S. Appl. No. 12/037,802, filed Feb. 26, 2008, 9 pages. |
Final Office Action dated Sep. 20, 2011, for U.S. Appl. No. 12/212,511, filed Sep. 17, 2008, 8 pages. |
Final Office Action dated Oct. 28, 2011, for U.S. Appl. No. 12/055,213, filed Mar. 25, 2008, 15 pages. |
Final Office Action dated May 4, 2012, for U.S. Appl. No. 12/363,359, filed Jan. 30, 2009, 10 pages. |
Final Office Action dated Nov. 14, 2014, for U.S. Appl. No. 12/363,359, filed Jan. 30, 2009, 10 pages. |
Final Office Action dated May 16, 2012, for U.S. Appl. No. 12/363,381, filed Jan. 30, 2009, 8 pages. |
Final Office Action dated Jul. 11, 2012, for U.S. Appl. No. 13/033,532, filed Feb. 23, 2011, 8 pages. |
Final Office Action dated Jul. 24, 2012, for U.S. Appl. No. 12/212,511, filed Sep. 17, 2008, 6 pages. |
Final Office Action dated Oct. 18, 2012, for U.S. Appl. No. 12/124,023, filed May 20, 2008, 15 pages. |
Final Office Action dated Nov. 8, 2013, for U.S. Appl. No. 12/037,802, filed Feb. 26, 2008, 15 pages. |
Final Office Action dated Jan. 13, 2014, for U.S. Appl. No. 12/752,873, filed Apr. 1, 2010, 10 pages. |
Final Office Action dated Oct. 22, 2013 for U.S. Appl. No. 13/086,390, filed Apr. 13, 2011, 6 pages. |
Final Office Action dated Aug. 12, 2014, for U.S. Appl. No. 13/033,532, filed Feb. 23, 2011, 6 pages. |
Fisher, D.C. et al. (Dec. 1998). “Large Gradient Across a Partially Ligated Left Atrial Appendage,” Journal of the American Society of Echocardiography 11(12):1163-1165. |
Friberg, L. et al. (2006). “Stroke Prophylaxis in Atrial Fibrillation: Who Gets it and Who Does Not?” European Heart Journal 27:1954-1964. |
Friedman, P.A. et al. (Aug. 2009). “Percutaneous Epicardial Left Atrial Appendage Closure: Preliminary Results of an Electrogram Guided Approach,” Journal of Cardiovascular Electrophysiology 20(8):908-915. |
Fuster, V. et al. (Oct. 2001). “ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation,” European Heart Journal 22(20):1852-1923. |
Garcia-Fernandez, M.A. et al. (Oct. 1, 2003). “Role of Left Atrial Appendage Obliteration in Stroke Reduction in Patients With Mitral Valve Prosthesis,” Journal of the American College of Cardiology 42(7):1253-1258. |
Gardiner, G.A. Jr. et al. (Apr. 1986). “Complications of Transluminal Angioplasty,” Radiology 159(1):201-208. |
Gillinov, A.M. (Feb. 2007). “Advances in Surgical Treatment of Atrial Fibrillation,” Stroke 38(part 2):618-623. |
Gilman, R.A. et al. (Apr. 1963). “Direct Left Ventricular Puncture,” California Medicine 98(4):200-203. |
Goodwin, W.E. et al. (Nov. 1950). “Translumbar Aortic Puncture and Retrograde Catheterization of the Aorta in Aortography and Renal Arteriography,” Annals of Surgery 132(5):944-958. |
Gottlieb, L.K. et al. (Sep. 12, 1994). “Anticoagulation in Atrial Fibrillation,” Arch Intern Med. 154:1945-1953. |
Graffigna, A. et al. (1993). “Surgical Treatment of Wolff-Parkinson-White Syndrome: Epicardial Approach Without the Use of Cardiopulmonary Bypass,” J. Card. Surg. 8:108-116. |
Haissaguerre, M. et al. (Nov. 2005). “Catheter Ablation of Long-Lasting Persistent Atrial Fibrillation: Clinical Outcome and Mechanisms of Subsequent Arrhythmias,” Journal of Cardiovascular Electrophysiology 16(11):1138-1147. |
Halperin, J.L. et al. (Aug. 1988). “Atrial Fibrillation and Stroke: New Ideas, Persisting Dilemmas,” Journal of the American Heart Association 19(8):937-941. |
Halperin, J.L. et al. (Oct. 1, 2003). “Obliteration of the Left Atrial Appendage for Prevention of Thromboembolism,” Journal of the American College of Cardiology 42(7):1259-1261. |
Hammill, S.C. (May 2006). “Epicardial Ablation: Reducing the Risks,” J. Cardiovasc. Electrophysiol. 17:550-552. |
Hara, H. et al. (Jan. 2008). “Percutaneous Left Atrial Appendage Obliteration,” JACC: Cardiovascular Imagin 1(1):92-93. |
Hart, R.G. et al. (Nov. 2, 1999). “Atrial Fibrillation and Thromboembolism: A Decade of Progress in Stroke Prevention,” Annals of Internal Medicine 131(9):688-695. |
Hart, R.G. et al. (Mar. 2001). “Atrial Fibrillation and Stroke: Concepts and Controversies,” Stroke 32:803-808. |
Hart, R.G. (Sep. 11, 2003). “Atrial Fibrillation and Stroke Prevention,” The New England Journal of Medicine 349(11):1015-1016. |
Healey, J.S. et al. (Oct. 2003). “Surgical Closure of the Left Atrial Appendage for the Prevention of Stroke: A Randomized Pilot Trial of Safety and Efficacy (The Left Atrial Appendage Occlusion Study—LAAOS),” presented at The Canadian Cardiovascular Congress 2003, Toronto, Canada, Abstract No. 666, 2 pages. |
Healey, J.S. et al. (Aug. 2005). “Left Atrial Appendage Occlusion Study (LAAOS): Results of a Randomized Controlled Pilot Study of Left Atrial Appendage Occlusion During Coronary Bypass Surgery in Patients At Risk for Stroke,” American Heart Journal 150(2):288-293. |
Hein, R. et al. (2005). “Patent Foramen Ovale and Left Atrial Appendage: New Devices and Methods for Closure,” Pediatric Cardiology 26(3):234-240. |
Heist, E.K. et al. (Nov. 2006). “Analysis of the Left Atrial Appendage by Magnetic Resonance Angiography in Patients with Atrial Fibrillation,” Heart Rhythm 3(11):1313-1318. |
Ho, I. et al. (Apr. 24, 2007). “Percutaneous Epicardial Mapping Ablation of a Posteroseptal Accessory Pathway,” Circulation 115:e418-e421. |
Ho, S.Y. et al. (Nov. 1999). “Anatomy of the Left Atrium: Implications for Radiofrequency Ablation of Atrial Fibrillation,” Journal of Cardiovascular Electrophysiology 10(11):1525-1533. |
Hoit, B.D. et al. (Jan. 1993). “Altered Left Atrial Compliance After Atrial Appendectomy. Influence on Left Atrial and Ventricular Filling,” Circulation Research 72(1):167-175. |
Inoue, Y. et al. (Jul.-Aug. 1997). “Video Assisted Thoracoscopic and Cardioscopic Radiofrequency Maze Ablation,” Asaio Journal 43(4):334-337, Abstract Only. |
International Search Report dated Jul. 13, 2011, for PCT Patent Application No. PCT/US11/00676, filed on Apr. 13, 2011, 2 pages. |
Jaïs, P. et al. (2003). “Radiofrequency Ablation for Atrial Fibrillation,” European Society of Cardiology 5(Supplement H):H34-H39. |
Johnson, W.D. et al. (2000). “The Left Atrial Appendage: Our Most Lethal Human Attachment! Surgical Implications,” Euro. J. Cardiothoracic. Surg. 17:718-722. |
Jongbloed, M.R.M. et al. (2005). “Clinical Applications of Intracardiac Echocardiography in Interventional Procedures,” Heart 91:981-990. |
Kamohara, K. et al. (Aug. 2006). “Evaluation of a Novel Device for Left Atrial Appendage Exclusion: The Second-generation Atrial Exclusion Device,” The Journal of Thoracic and Cardiovascular Surgery 132(2):340-346. |
Kanderian, A.S. et al. (2008). “Success of Surgical Left Atrial Appendage Closure: Assessment by Transesophageal Echocardiography,” Journal of the American College of Cardiology 52(11):924-929. |
Kato, H. et al. (Aug. 1, 1996). “Evaluation of Left Atrial Appendage Stasis in Patients With Atrial Fibrillation Using Transesophageal Echocardiography With an Intravenous Albumin-Contrast Agent,” The American Journal of Cardiology 78:365-369. |
Katz, E.S. et al. (Aug. 2000). “Surgical Left Atrial Appendage Ligation is Frequently Incomplete: A Transesophageal Echocardiographic Study,” Journal of the American College of Cardiology 36(2):468-471. |
Kenner, H.M. et al. (Dec. 1966). “Intrapericardial, Intrapleural, and Intracardiac Pressures During Acute Heart Failure in Dogs Studied without Thoracotomy,” Circulation Research 19:1071-1079. |
Kerut, E.K. et al. (Jul. 2008). “Anatomy of the Left Atrial Appendage,” Echocardiography 25(6):669-673. |
Khargi, K. et al. (2005). “Surgical Treatment of Atrial Fibrillation: A Systematic Review,” European Journal of Cardiothoracic Surgery 27:258-265. |
Kim, K.B. et al. (Jan. 1998). “Effect of the Cox Maze Procedure on the Secretion of Atrial Natriuretic Peptide,” J. Thorac. Cardiovasc. Surg. 115(1):139-146; discussion 146-147. |
Kistler, P.M. et al. (May 2007). “The Left Atrial Appendage: Not Just an Innocent Bystander,” J. Cardiovasc Electrophysiol 18(5):465-466. |
Klein, H. et al. (Apr. 1990). “The Implantable Automatic Cardioverter-Defibrillator,” Herz 15(2):111-125, Abstract Only. |
Kolb, C. et al. (Feb. 2004). “Incidence of Antitachycardia Therapy Suspension Due to Magnet Reversion in Implantable Cardioverter Defibrillators,” Pace 27:221-223. |
Krikorian, J.G. et al. (Nov. 1978). “Pericardiocentesis,” Am. J. Med. 65(5):808-814. |
Krum, D. et al. (2004). “Visualization of Remnants of the left Atrial Appendage Following Epicardial Surgical Removal,” Heart Rhythm 1:249. |
Lacomis, J.M. et al. (Oct. 2003). “Multi-Detector Row CT of the Left Atrium and Pulmonary Veins before Radio-frequency Catheter Ablation for Atrial Fibrillation,” Radio Graphics 23:S35-S48. |
Lacomis, J.M. et al. (2007, e-pub. Oct. 17, 2007). “Dynamic Multidimensional Imaging of the Human Left Atrial Appendage,” Europace 9:1134-1140. |
Lee, R. et al. (1999). “The Closed Heart MAZE: A Nonbypass Surgical Technique,” The Annals of Thoracic Surgery 67:1696-1702. |
Levinson, M.L. et al. (1998). “Minimally Invasive Atrial Septal Defect Closure Using the Subxyphoid Approach,” Heart Surg. Forum 1(1):49-53, Abstract Only. |
Lewis, D.R. et al. (1999). “Vascular Surgical Intervention for Complications of Cardiovascular Radiology: 13 Years' Experience in a Single Centre,” Ann. R. Coll. Surg. Engl. 81:23-26. |
Li, H. (2007). “Magnet Decoration, Beautiful But Potentially Dangerous for Patients with Implantable Pacemakers or Defibrillators,” Heart Rhythm 4(1):5-6. |
Lindsay, B.D. (1996). “Obliteration of the Left Atrial Appendage: A Concept Worth Testing,” The Annals of Thoracic Surgery 61:515-516. |
Lip, G.Y.H. et al. (Jun. 2001). “Thromboprophylaxis for Atrial Flutter,” European Heart Journal 22(12):984-987. |
Lustgarten, D.L. et al. (May/Jun. 1999). “Cryothermal Ablation: Mechanism of Tissue Injury and Current Experience in the Treatment of Tachyarrhythmias,” Progress in Cardiovascular Diseases 41(6):481-498. |
Macris, M. et al. (Jan. 1999). “Minimally Invasive Access of the Normal Pericardium: Initial Clinical Experience with a Novel Device,” Clin. Cardiol. 22(Suppl. I):I-36-I-39. |
Maisch, B. et al. (Jan. 1999). “Intrapreicardial Treatment of Inflammatory and Neoplastic Pericarditis Guided by Pericardioscopy and Epicardial Biopsy-Results from a Pilot Study,” Clin. Cardiol. 22(Supp. I):I-17-I-22. |
Mannam, A.P. et al. (Apr. 1, 2002). “Safety of Subxyphoid Pericardial Access Using a Blunt-Tip Needle,” The American Journal of Cardiology 89:891-893. |
Mattox, K.L. et al. (May 1997). “Newer Diagnostic Measure and Emergency Management,” Ches Surg Clin N Am. 7(2):213-226, Abstract Only. |
McCarthy, P.M. et al. (2008). “Epicardial Atrial Fibrillation Ablation,” Chapter 23 in Contemporary Cardiology: Atrial Fibrillation, From Bench to Bedside, Natale, A. et al. eds., Humana Press,: Totowa, NJ, pp. 323-332. |
McCaughan, J.J. Jr., et al. (Nov. 1957). “Aortography Utilizing Percutaneous Left Ventricular Puncture,” located at <http://www.archsurg.com>, last visited on Apr. 7, 2009, 73:746-751. |
McClelland, R.R. (1978). “Congenital Aneurysmal Dilatation of the Left Auricle Demonstrated by Sequential Cardiac Blood-Pool Scintiscanning,” J. Nucl. Med. 19(5):507-509. |
Melo, J. et al. (Apr. 21, 2008). “Surgery for Atrial Fibrillation in Patients with Mitral Valve Disease: Results at Five Years from the International Registry of Atrial Fibrillation Surgery,” The Journal of Thoracic and Cardiovascular Surgery 135(4):863-869. |
Miller, P.S.J. et al. (Feb. 2005). “Are Cost Benefits of Anticoagulation for Stroke Prevention in Atrial Fibrillation Underestimated?” Stroke 36:360-366. |
Miyasaka, Y. et al. (Jul. 11, 2006). “Secular Trends in Incidence of Atrial Fibrillation in Olmsted County, Minnesota, 1980 to 2000, and Implications on the Projections for Future Prevalence,” Circulation 114:119-125. |
Morris, J.J. Jr. (1979). “Transvenous versus Transthoracic Cardiac Pacing,” Chapter 16 in Cardiac Pacing: A Concise Guide to Clinical Practice, pp. 239-245. |
Mráz, T. et al. (Apr. 2007). “Role of Echocardiography in Percutaneous Occlusion of the left Atrial Appendage,” Echocardiography 24(4):401-404. |
Naclerio, E.A. et al. (1979). “Surgical Techniques for Permanent Ventricular Pacing,” Chapter 10 in Cardiac Pacing: A Concise Guide to Clinical Practice, pp. 145-168. |
Nakai, T. et al. (May 7, 2002). “Percutaneous Left Atrial Appendage Occlusion (PLAATO) for Preventing Cardioembolism: First Experience in Canine Model,” Circulation 105:2217-2222. |
Nakajima, H. et al. (2004). “Consequence of Atrial Fibrillation and the Risk of Embolism After Percutaneous Mitral Commissurotomy: The Necessity of the Maze Procedure,” The Annals of Thoracic Surgery 78:800-806. |
Non-Final Office Action dated Feb. 5, 2014 for U.S. Appl. No. 13/086,389, filed Apr. 13, 2011, 16 pages. |
Non-Final Office Action dated Mar. 13, 2008 for U.S. Appl. No. 10/963,371, filed Oct. 11, 2004, 14 pages. |
Non-Final Office Action dated Aug. 6, 2008 for U.S. Appl. No. 10/963,371, filed Oct. 11, 2004, 14 pages. |
Non-Final Office Action dated Jun. 26, 2009, for U.S. Appl. No. 11/600,671, filed Nov. 15, 2006, 9 pages. |
Non-Final Office Action dated Dec. 30, 2009, for U.S. Appl. No. 11/400,714, filed Apr. 7, 2006, 8 pages. |
Non-Final Office Action dated Jul. 22, 2010, for U.S. Appl. No. 12/037,802, filed Feb. 26, 2008, 10 pages. |
Non-Final Office Action dated Nov. 15, 2010, for U.S. Appl. No. 12/055,213, filed Mar. 25, 2008, 18 pages. |
Non-Final Office Action dated Feb. 17, 2011, for U.S. Appl. No. 12/212,511, filed Sep. 17, 2008, 14 pages. |
Non-Final Office Action dated Apr. 28, 2011, for U.S. Appl. No. 12/055,213, filed Mar. 25, 2008, 20 pages. |
Non-Final Office Action dated Oct. 27, 2011, for U.S. Appl. No. 12/363,359, filed Jan. 30, 2009, 11 pages. |
Non-Final Office Action dated Nov. 9, 2011, for U.S. Appl. No. 12/363,381, filed Jan. 30, 2009, 10 pages. |
Non-Final Office Action dated Dec. 22, 2011, for U.S. Appl. No. 13/033,532, filed Feb. 23, 2011, 8 pages. |
Non-Final Office Action dated Mar. 7, 2012, for U.S. Appl. No. 12/124,023, filed May 20, 2008, 13 pages. |
Non-Final Office Action dated Apr. 2, 2012, for U.S. Appl. No. 12/212,511, filed Sep. 17, 2008, 5 pages. |
Non-Final Office Action dated Sep. 18, 2013, for U.S. Appl. No. 12/055,213, filed Mar. 25, 2008, 15 pages. |
Non-Final Office Action dated May 31, 2013, for U.S. Appl. No. 12/124,023, filed May 20, 2008, 14 pages. |
Non-Final Office Action dated Apr. 2, 2014, for U.S. Appl. No. 13/033,532, filed Feb. 23, 2011, 8 pages. |
Non-Final Office Action dated Oct. 28, 2015, for U.S. Appl. No. 13/033,532, filed Feb. 23, 2011, 9 pages. |
Non-Final Office Action dated Jun. 17, 2014, for U.S. Appl. No. 12/363,359, filed Jan. 30, 2009, 7 pages. |
Non-Final Office Action dated Sep. 10, 2015, for U.S. Appl. No. 12/363,359, filed Jan. 30, 2009, 12 pages. |
Non-Final Office Action dated Nov. 10, 2014, for U.S. Appl. No. 12/752,873, filed Apr. 1, 2010, 10 pages. |
Non-Final Office Action dated May 4, 2015, for U.S. Appl. No. 12/124,023, filed May 20, 2008, 8 pages. |
Non-Final Office Action dated May 3, 2013 for U.S. Appl. No. 13/086,390, filed Apr. 13, 2011, 10 pages. |
Non-Final Office Action dated Jan. 15, 2015, for U.S. Appl. No. 13/086,389, filed Apr. 13, 2011, 16 pages. |
Non-Final Office Action dated Dec. 2, 2015, for U.S. Appl. No. 14/309,835, filed Jun. 19, 2014, 8 pages. |
Notice of Allowance dated Mar. 20, 2014 for U.S. Appl. No. 13/086,390, filed Apr. 13, 2011, 8 pages. |
Notice of Allowance dated Sep. 17, 2010, for U.S. Appl. No. 10/963,371, filed Oct. 11, 2004, 7 pages. |
Notice of Allowance dated Sep. 17, 2010, for U.S. Appl. No. 11/600,671, filed Nov. 15, 2006, 7 pages. |
Notice of Allowance dated Nov. 24, 2010, for U.S. Appl. No. 11/400,714, filed Apr. 7, 2006, 8 pages. |
Notice of Allowance dated Feb. 22, 2013, for U.S. Appl. No. 12/212,511, filed Sep. 17, 2008, 8 pages. |
Notice of Allowance dated Mar. 18, 2013, for U.S. Appl. No. 12/212,511, filed Sep. 17, 2008, 6 pages. |
Notice of Allowance dated Mar. 4, 2014, for U.S. Appl. No. 12/055,213, filed Mar. 25, 2008, 9 pages. |
Notice of Allowance dated Apr. 1, 2014, for U.S. Appl. No. 12/363,381, filed Jan. 30, 2009, 9 pages. |
Notice of Allowance dated Dec. 29, 2014, for U.S. Appl. No. 12/363,381, filed Jan. 30, 2009, 9 pages. |
Notice of Allowance dated Apr. 3, 2014, for U.S. Appl. No. 12/037,802, filed Feb. 26, 2008, 8 pages. |
Notice of Allowance dated Jul. 22, 2015, for U.S. Appl. No. 12/752,873, filed Apr. 1, 2010, 8 pages. |
Notice of Allowance dated Oct. 21, 2015, for U.S. Appl. No. 12/124,023, filed May 20, 2008, 9 pages. |
Odell, J.A. et al. (1996). “Thorascopic Obliteration of the Left Atrial Appendage: Potential for Stroke Reduction?” Ann. Thorac. Surg. 61:565-569. |
O'Donnell, M. et al. (2005). “Emerging Therapies for Stroke Prevention in Atrial Fibrillation,” European Heart Journal 7(Supplement C):C19-C27. |
Omran, H. et al. (1997). “Left Atrial Appendage Function in Patients with Atrial Flutter,” Heart 78:250-254. |
Onalan, O. et al. (2005). “Nonpharmacologic Stroke Prevention in Atrial Fibrillation,” Expert Rev. Cardiovasc. Ther. 3(4):619-633. |
Onalan, O. et al. (2007). “Left Atrial Appendage Exclusion for Stroke Prevention in Patients With Nonrheumatic Atrial Fibrillation,” Stroke 38(part 2):624-630. |
Ostermayer, S. et al. (2003). “Percutaneous Closure of the Left Atrial Appendage,” Journal of Interventional Cardiology 16(6):553-556. |
Ota, T. et al. (2006). “Epicardial Atrial Ablation Using a Novel Articulated Robotic Medical Probe Via a Percutaneous Subxiphoid Approach,” National Institute of Health 1(6):335-340. |
Ota, T. et al. (Oct. 2007). “Impact of Beating Heart left Atrial Ablation on Left-sided Heart Mechanics,” The Journal of Thoracic and Cardiovascular Surgery 134(4):982-988. |
Pennec, P-Y. et al. (2003). “Assessment of Different Procedures for Surgical Left Atrial Appendage Exclusion,” The Annals of Thoracic Surgery 76:2167-2168. |
Perk, G. et al. (Aug. 2009). “Use of Real Time Three-Dimensional Transesophageal Echocardiography in Intracardiac Catheter Based Interventions,” J. Am Soc Echocardiogr 22(8):865-882. |
Pollick C. (Feb. 2000). “Left Atrial Appendage Myopathy,” Chest 117(2):297-308. |
Poulsen, T.S. et al. (Feb. 15, 2005). “Is Aspirin Resistance or Female Gender Associated With a High Incidence of Myonecrosis After Nonurgent Percutaneous Coronary Intervention?” J. Am. Coll. Cardiol. 45(4):635-636. |
Reznik, G. et al. (Oct. 1992). “Percutaneous Endoscopic Implantation of Automatic Implantable Cardioverter/Defibrillator (AICD): An Animal Study of a New Nonthoracotomy Technique,” J. Laparoendosc. Surg. 2(5):255-261, Abstract Only. |
Robicsek, F. (1987). “Closed-Chest Decannulation of Transthoracically Inserted Aortic Balloon Catheter without Grafting,” Journal of Cardiac Surgery 2(2):327-329. |
Ross, J. Jr. et al. (Jun. 3, 2008). “Transseptal Left Heart Catheterization: A 50-Year Odyssey,” Journal of the American College of Cardiology 51(22):2107-2115. |
Rubin, D.N. et al. (Oct. 1, 1996). “Evaluation of Left Atrial Appendage Anatomy and Function in Recent-Onset Atrial Fibrillation by Transesophageal Echocardiography,” Am J Cardiol 78:774-778. |
Ruchat, P. et al. (2002). “Off-pump Epicardial Compartmentalization for Ablation of Atrial Fibrillation,” Interactive Cardio Vascular and Thoracic Surgery 1:55-57. |
Salzberg, S.P. et al. (2008). “Surgical Left Atrial Appendage Occlusion: Evaluation of a Novel Device with Magnetic Resonance Imaging,” European Journal of Cardiothoracic Surgery 34:766-770. |
Sapp, J. et al. (Dec. 2001). “Electrophysiology and Anatomic Characterization of an Epicardial Accessory Pathway,” Journal of Cardiovascular Electrophysiology 12(12):1411-1414. |
Scharf, C. et al. (2005). “Catheter Ablation for Atrial Fibrillation: Pathophysiology, Techniques, Results and Current Indications,” Continuous Medical Education 8:53-61. |
Scherr, D. et al. (Apr. 2009). “Incidence and Predictors of left Atrial Thrombus Prior to Catheter Ablation of Atrial Fibrillation,” Journal of Cardiovascular Electrophysiology 20(4):379-384. |
Schmidt, H. et al. (Sep. 2001). “Prevalence of Left Atrial Chamber and Appendage Thrombi in Patients With Atrial Flutter and Its Clinical Significance,” Journal of the American College of Cardiology 38(3):778-784. |
Schneider, B. et al. (2005, e-pub. Aug. 22, 2005). “Surgical Closure of the Left Atrial Appendage—A Beneficial Procedure?” Cardiology 104:127-132. |
Schweikert, R.A. et al. (Sep. 16, 2003). “Percutaneous Pericardial Instrumentation for Endo-Epicardial Mapping of Previously Failed Ablation,” Circulation 108:1329-1335. |
Schweikert, R.A. et al. (2005). “Epicardial Access: Present and Future Applications for Interventional Electrophysiologists,” Chapter 25 in New Arrhythmia Technolgies, Wang, P.J. ed., Blackwell Publishing, pp. 242-256. |
Seferovic, P. et al. (Jan. 1999). “Initial Clinical Experience with the PerDUCER® Device: Promising New Tool in the Diagnosis and Treatment of Pericardial Disease,” Clin. Cardiol. 22(Supp I):I-30-I-35. |
Sengupta, P.P. et al. (2005). “Transoesophageal Echocardiography,” Heart 91:541-547. |
Sharada, K. et al. (2005). “Non-Surgical Transpericardial Catheter Ablation of Post-Infarction Ventricular Tachycardia,” Indian Heart J 57:58-61. |
Sievert, H. et al. (Apr. 23, 2002). “Percutaneous Left Atrial Appendage Transcatheter Occlusion to Prevent Stroke in High-Risk Patients With Atrial Fibrillation,” Circulation 105:1887-1889. |
Singer, D.E. et al. (Sep. 2004). “Antithrombotic Therapy in Atrial Fibrillation: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy,” Chest 126(3):429S-456S. |
Smith, P.W. et al. (Nov. 1956). “Diagnosis of Mitral Regurgitation by Cardioangiography,” Circulation 14:847-853. |
Soejima, K. et al. (2004). “Subxiphoid Surgical Approach for Epicardial Catheter-Based Mapping and Ablation in Patients With Prior Cardiac Surgery or Difficult Pericardial Access,” Circulation 110:1197-1201. |
Sosa, E. et al. (1996). “A New Technique to Perform Epicardial Mapping in the EP Laboratory,” J. Cardiovasc. Electrophysiol. 7(6):531-536. |
Sosa, E. et al. (Mar. 1998). “Endocardial and Epicardial Ablation Guided by Nonsurgical Transthoracic Epicardial Mapping to Treat Recurrent Ventricular Tachycardia,” J. Cardiovasc. Elecytophysiol. 9(3):229-239. |
Sosa, E. et al. (Dec. 14, 1999). “Different Ways of Approaching the Normal Pericardial Space,” Circulation 100(24):e115-e116. |
Sosa, E. et al. (Jul. 15, 2002). “Gaining Access to the Pericardial Space,” The American Journal of Cardiology 90:203-204. |
Sosa, E. et al. (Apr. 2005). “Epicardial Mapping and Ablation Techniques to Control Centricular Tachycardia,” Journal of Cardiovasc. Electrphsiol. 16(4):449-452. |
Sparks, P.B. et al. (2001). “Is Atrial Flutter a Risk Factor for Stroke?” Journal of the American College of Cardiology 38(3):785-788. |
Spodick, D.H. (Nov. 1970). “Medical History of the Pericardium,” The American Journal of Cardiology 26:447-454. |
Stewart, J.M. et al. (Apr. 1992). “Bilateral Atrial Appendectomy Abolishes Increased Plasma Atrial Natriuretic Peptide Release and Blunts Sodium and Water Excretion During Volume Loading in Conscious Dogs,” Circulation Research 70(4):724-732. |
Stewart, S. (1974). “Placement of the Sutureless Epicardial Pacemaker Lead by the Subxiphoid Approach,” Ann. of Thoracic Surg. 18(3):308-313. |
Stoddard, M.F. et al. (1995). “Left Atrial Appendage Thrombus is not Uncommon in Patients with Acute Atrial Fibrillation and a Recent Embolic Event: A Transesophageal Echocardiographic Study,” J. Am. Coll. Cardiol. 25:452-459, Abstract Only. |
Stokes, K. (Jun. 1990). “Implantable Pacing Lead Technology,” IEEE Engineering in Medicine and Biology pp. 43-49. |
Stöllberger, C. et al. (2000). “Is the Left Atrial Appendage Our Most Lethal Attachment?” European Journal of Cardio-Thoracic Surgery 18:625-626. |
Stöllberger, C. et al. (Dec. 2003). “Elimination of the Left Atrial Appendage to Prevent Stroke or Embolism?: Anatomic, Physiologic, and Pathophysiologic Considerations,” 124(6):2356-2362. |
Stöllberger, C. et al. (2006). “Stroke Prevention by Means of Epicardial Occlusion of the Left Atrial Appendage,” Journal of Thoracic and Cardiovascular Surgery 132(1):207-208. |
Stöllberger, C. et al. (2007). “Arguments Against Left Atrial Appendage Occlusion for Stroke Prevention,” Stroke 38:e77. |
Stöllberger, C. et al. (2007). “Leave the Left Atrial Appendage Untouched for Stroke Prevention!” Journal of Thoracic and Cardiovascular Surgery 134(2):549-550. |
Su, P. et al. (Sep. 2008, e-pub. May 8, 2007). “Occluding the Left Atrial Appendage: Anatomical Considerations,” Heart 94(9):1166-1170. |
Subramanian, V.A. (Jun. 1997). “Less Invasive Arterial CABG on a Beating Heart,” Ann. Thorac. Surg. 63(6 Suppl.):S68-S71. |
Subramanian, V.A. et al. (Dec. 1997). “Minimally Invasive Direct Coronary Artery Bypass Grafting: Two-Year Clinical Experience,” Ann. Thorac. Surg. 64(6):1648-1653, Abstract Only. |
Suehiro, S. et al. (1996). “Echocardiography-Guided Pericardiocentesis With a Needle Attached to a Probe,” Ann. Thoracic Surg. 61:741-742. |
Sun, F. et al. (Feb. 2006). “Subxiphoid Access to Normal Pericardium with Micropuncture Set: Technical Feasibility Study in Pigs,” Radiology 238(2):719-724. |
Szili-Torok, T. et al. (2001). “Transseptal Left heart Catheterisation Guided by Intracardiac Echocardiography,” Heart 86:e11-e15. |
Tabata, T. et al. (Feb. 1, 1998). “Role of Left Atrial Appendage in left Atrial Reservoir Function as Evaluated by Left Atrial Appendage Clamping During Cardiac Surgery,” The American Journal of Cardiology 81:327-332. |
Tomar, M. et al. (Jul.-Aug. 2006). “Transcatheter Closure of Fossa Ovalis Atrial Septal Defect: A Single Institutional Experience,” Indian Heart Journal 58(4):325-329. |
Troughton, R.W. et al. (Feb. 28, 2004). “Pericarditis,” The Lancet 363:717-727. |
Ulicny K.S. et al. (Jun. 1992). “Conjoined Subrectus Pocket for Permanent Pacemaker Placement in the Neonate,” Ann Thorac Surg. 53(6):1130-1131, Abstract Only. |
Valderrabano, M. et al. (Sep. 2004). “Percutaneous Epicardial Mapping During Ablation of Difficult Accessory Pathways as an Alternative to Cardiac Surgery,” Heart Rhythm 1(3):311-316. |
Von Korn, H. et al. (2006). “Simultaneous Combined Interventional Percutaneous Left Atrial Auricle and Atrial Septal Defect Closure,” Heart 92:1462. |
Wang, T.J. et al. (Aug. 27, 2003). “A Risk Score for Predicting Stroke or Death in Individuals With New-Onset Atrial Fibrillation in the Community,” American Medical Association 290(8):1049-1056. |
Watkins, L. et al. (Nov. 1982). “Implantation of the Automatic Defibrillator: The Subxiphoid Approach,” Ann. of Thoracic Surg. 34(5):515-520. |
W.L. Gore & Associates (Aug. 11, 2006). “Gore Helex™ Septal Occluder,” located at <http://www.fda.gov/cdrh/pdf5/p050006a.pdf>, last visited on Jun. 14, 2007, 3 pages. |
Wolber, T. et al. (Jan. 2007). “Potential Interference of Small Neodymium Magnets with Cardiac pacemakers and Implantable Cardioverter-defibrillators,” Heart Rhythm 4(1):1-4. |
Wolf, P.A. et al. (Oct. 1978). “Epidemiologic Assessment of Chronic Atrial Fibrillation and Risk of Stroke: The Fiamingham Study,” Neurology 28:973-977. |
Wolf, P.A. et al. (Aug. 1991). “Atrial Fibrillation as an Independent Risk Factor for Stroke: The Framingham Study,” Stroke 22(8):983-988. |
Wolf, P.A. et al. (Feb. 9, 1998). “Impact of Atrial Fibrillation on Mortality, Stroke, and Medical Costs,” Arch Intern Med 158:229-234. |
Wong, J.W.W. et al. (2006). “Impact of Maze and Concomitant Mitral Valve Surgery on Clinical Outcomes,” The Annals of Thoracic Surgery 82:1938-1947. |
Wongcharoen, W. et al. (Sep. 2006). “Morphologic Characteristics of the Left Atrial Appendage, Roof, and Septum: Implications for the Ablation of Atrial Fibrillation,” Journal of Cardiovascular Electrophysiology 17(9):951-956. |
Wood, M.A. (Jan. 2006). “Percutaneous Pericardial Instrumentation in the Electrophysiology Laboratory: A Case of Need,” Heart Rhythm 3(1):11-12. |
Written Opinion of the International Searching Authority dated Jul. 13, 2011, for PCT Patent Application No. PCT/US11/00676, filed on Apr. 13, 2011, 6 pages. |
Wudel, J.H. et al. (Apr. 3, 2008). “Video-Assisted Epicardial Ablation and left Atrial Appendage Exclusion for Atrial Fibrillation: Extended Follow-Up,” The Annals of Thoracic Surgery 85:34-38. |
Wyse, D.G. et al. (Dec. 5, 2002). “Of ‘left Atrial Appendage Amputation, Ligation, or Occlusion in Patients with Atrial Fibrillation’,” N Engl J Med 347(23):1825-1833, Abstract Only. |
Yamada, Y. et al. (Aug. 2006). “Video-Assisted Thoracoscopy to Treat Atrial Tachycardia Arising from Left Atrial Appendage,” Journal of Cardiovascular Electrophysiology 17(8):895-898. |
Zapolanski, A. et al. (May 2008). “Safe and Complete Exclusion of the left Atrial Appendage, A Simple Epicardial Approach,” Innovations 3(3):161-163. |
Zenati, M.A. et al. (Sep. 2003). “Left Heart Pacing Lead Implantation Using Subxiphoid Videopericardioscopy,” Journal of Cardiovascular Electrophysiology 14(9):949-953. |
Zenati, M.A. et al. (2004). “Mechanical Function of the Left Atrial Appendage Following Epicardial Bipolar Radiofrequency Ablation,” Cardiothoracic Techniques and Technologies X, Abstract 121A, p. 176. |
Zenati, M.A. et al. (2005). “Modification of the Left Atrial Appendage,” Chapter 12 in Innovative Management of Atrial Fibrillation, Schwartzman, David ed., Blackwell Science Ltd., 5 pages. |
U.S. Appl. No. 14/928,836, filed Oct. 30, 2015, by Fung et al. |
Non-Final Office Action dated Jan. 12, 2018, for U.S. Appl. No. 14/928,836, filed Oct. 30, 2015, 12 pages. |
Non-Final Office Action dated Jan. 26, 2018, for U.S. Appl. No. 14/625,540, filed Feb. 18, 2015, 16 pages. |
Number | Date | Country | |
---|---|---|---|
20160008061 A1 | Jan 2016 | US |
Number | Date | Country | |
---|---|---|---|
61323796 | Apr 2010 | US | |
61323801 | Apr 2010 | US | |
61323816 | Apr 2010 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 13086389 | Apr 2011 | US |
Child | 14799419 | US |