Apparatus and methods for alignment and deployment of intracardiac devices

Information

  • Patent Grant
  • 10555718
  • Patent Number
    10,555,718
  • Date Filed
    Wednesday, March 30, 2016
    8 years ago
  • Date Issued
    Tuesday, February 11, 2020
    4 years ago
Abstract
Apparatus and methods are described herein for use in the alignment and deployment of a prosthetic heart valve, such as a mitral valve. In some embodiments, an apparatus includes a tube assembly and a needle assembly configured to be received through a lumen of an outer tube member of the tube assembly. The needle assembly includes an elongate needle having a distal tip configured to be inserted through the epicardial surface of a heart. An imaging probe is coupled to a coupling member and includes an imaging element. The imaging probe is configured to provide image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of the mitral valve and the annular region of the heart such that a prosthetic mitral valve can be positioned within the heart based at least in part on the C-C plane and the A-P plane.
Description
BACKGROUND

Embodiments are described herein that relate to devices and methods for use in the deployment and alignment of a medical device such as an intracardiac device.


When deploying a prosthetic mitral valve, it is important that the valve is seated within the native annulus (for valves that do not require excision of the native valve) in such a manner as to avoid hemodynamic leakage. Leaking can occur where the prosthetic valve meets the commissures, meets the anterior leaflets, and/or meets the posterior leaflets. Accordingly, some newer generation valves are equipped with a flange or cuff that is atrially seated, maintains patency during its lifetime, and funnels cardiac atrial output through a one-way valve and into the ventricle. Accordingly, proper alignment of the annular seal is critical to the effectiveness of the valve and to the life of the patient. Thus, devices for aligning the transventricular tether of such a valve would be considered useful to solve these and other problems known in the art.


SUMMARY

Apparatus and methods are described herein for use in the alignment and deployment of a transcatheter prosthetic valve, such as a prosthetic mitral valve. In some embodiments, an apparatus includes an outer tube member defining a lumen and a needle assembly configured to be received through the lumen of the outer tube member. The needle assembly includes an elongate needle having a distal tip configured to be inserted through the epicardial surface of a heart and extend within the left ventricle of the heart. An imaging probe is coupled to the needle assembly and includes a cable and an imaging element disposed at a distal end portion of the cable. The imaging probe is configured to provide image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of the mitral valve and the annular region of the heart such that a prosthetic mitral valve can be positioned within the heart based at least in part on the C-C plane and the A-P plane.





BRIEF DESCRIPTION OF THE FIGURES


FIG. 1 is a cross-sectional illustration of portion of a heart with a prosthetic mitral valve implanted therein and an epicardial anchor device anchoring the mitral valve in position.



FIG. 2A is a schematic illustration of an alignment device, according to an embodiment.



FIG. 2B is a schematic illustration of the alignment device of FIG. 2A shown positioned near an epicardial surface of a heart.



FIG. 3 is a perspective view of an alignment device, according to another embodiment.



FIG. 4 is another perspective view of the alignment device of FIG. 3.



FIG. 5A is a cross-sectional illustration of a portion of a heart with a prosthetic mitral valve deployed into the mitral annulus and having an anchoring tether extending through the ventricle and anchored to the epicardial surface of heart with an epicardial pad device.



FIG. 5B illustrates the commissural-commissural (C-C) plane and the anterior-posterior (A-P) plane of a mitral valve and annular region of a heart with a tether extending therebetween.



FIGS. 6A-6D are schematic illustrations showing various views of the prosthetic mitral valve and tether of FIG. 5A deployed within a heart.



FIG. 7 is a schematic illustration showing a line of sight between the commissural-commissural (C-C) plane and the anterior-posterior (A-P) plane of the mitral valve and tether of FIGS. 6A-6D deployed within the heart.



FIG. 8 is a plan view of an alignment device, according to another embodiment.



FIG. 9 is a perspective view of a portion of the alignment device of FIG. 8.



FIG. 10 is a perspective view of a needle assembly of the alignment device of FIG. 8.



FIG. 11 is a side view of the needle assembly disassembled and the tube assembly of the alignment device of FIG. 8.



FIG. 12 is an enlarged perspective view of a portion of the alignment device of FIG. 8 showing the cable and imaging element coupled to the imaging element mounting member.



FIG. 13 is a flowchart illustrating a method of deploying and aligning a prosthetic mitral valve, according to an embodiment.



FIG. 14 is a flowchart illustrating another method of deploying and aligning a prosthetic mitral valve, according to an embodiment.



FIG. 15 is a schematic illustration of a mitral valve deployment and alignment kit, according to an embodiment.



FIGS. 16 and 17 are each a screen shot of an ultrasound image of a heart showing an alignment path projected onto the image.





DETAILED DESCRIPTION

Apparatus and methods are described herein for use in the alignment and deployment of a transcatheter prosthetic valve, such as a prosthetic mitral valve. As described herein, an alignment device that includes an imaging probe can be used to determine a location and orientation for positioning a tether coupled to a prosthetic mitral valve and securing the tether with an epicardial pad at the epicardial surface of a heart.


In some embodiments, an alignment device includes a handheld intracardiac echocardiography (ICE) probe coupled to a percutaneous transmyocardial needle/tube component. The ICE probe can include a control wand connected to an imaging element with a cable. The imaging element includes a side-looking multi-element phased array transducer with multi-way steerability. The imaging probe can include a distal targeting loop for epicardial surface contact. The distal targeting loop can define an aperture and the percutaneous transmyocardial needle/tube component can be configured to travel along a longitudinal axis through the aperture. The alignment device is configured to facilitate alignment of the longitudinal axis of the percutaneous transmyocardial needle/tube component.


In some embodiments, the imaging probe is an 8 or 10 French probe. In some embodiments, the imaging element (e.g., transducer) can operate at a frequency ranging from about 5.0 to about 8.5 MHz. In some embodiments, the imaging probe is configured to provide greyscale imaging, color Doppler imaging, tissue imaging, and/or 3D localization.


In some embodiments, a method for aligning a prosthetic heart valve for deployment within a native mitral valve can include using an alignment device as described herein to identify the commissural-commissural (C-C) plane or axis and the anterior-posterior (A-P) plane or axis of the mitral valve and annular region. In some embodiments, the method can further include deploying an asymmetric compressed self-expanding transcatheter valve to the mitral annulus. The method further can further include orienting the asymmetric compressed self-expanding transcatheter valve to minimize left ventricular outflow tract (LVOT) obstruction.


In some embodiments, a surgical kit can include an alignment device as described herein and a transcatheter prosthetic valve delivery device both disposed within a sterile package. In some embodiments, a kit can further include a transcatheter valve (e.g., a prosthetic mitral valve) and/or an epicardial pad that can be used to secure the transcatheter valve in position within the heart.


As used herein, the words “proximal” and “distal” refer to a direction closer to and away from, respectively, an operator of, for example, a medical device. Thus, for example, the end of the medical device closest to the patient's body (e.g., contacting the patient's body or disposed within the patient's body) would be the distal end of the medical device, while the end opposite the distal end and closest to, for example, the user (or hand of the user) of the medical device, would be the proximal end of the medical device.


In some embodiments, an alignment device is described herein that can be used in conjunction with a procedure to deliver and anchor a compressible prosthetic heart valve replacement (e.g., a prosthetic mitral valve), which can be deployed into a closed beating heart using a transcatheter delivery system. An epicardial pad device or system can be used to anchor such a prosthetic heart valve replacement. Such an epicardial pad system can be deployed via a minimally invasive procedure such as, for example, a procedure utilizing the intercostal or subxyphoid space for valve introduction. In such a procedure, the prosthetic valve can be formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the target location, for example, the mitral or tricuspid valve annulus.


A compressible prosthetic mitral valve can have a shape, for example that features a tubular stent body that contains leaflets and an atrial cuff. This allows the valve to seat within the native mitral annulus. The use of a flexible valve attached using an apical tether can provide compliance with the motion and geometry of the heart. The geometry and motion of the heart are well-known as exhibiting a complicated biphasic left ventricular deformation with muscle thickening and a sequential twisting motion. The additional use of the apically secured ventricular tether helps maintain the prosthetic valve's annular position without allowing the valve to migrate, while providing enough tension between the cuff and the atrial trabeculations to reduce, and preferably eliminate, perivalvular leaking. The use of a compliant valve prosthesis and the special shape and features can help reduce or eliminate clotting and hemodynamic issues, including left ventricular outflow tract (LVOT) interference problems. Many known valves are not able to address problems with blood flow and aorta/aortic valve compression issues.


Structurally, the prosthetic heart valve can include, for example, a self-expanding tubular frame having a cuff at one end (the atrial end), one or more attachment points to which one or more tethers can be attached, preferably at or near the ventricular end of the valve, and a leaflet assembly that contains the valve leaflets, which can be formed from stabilized tissue or other suitable biological or synthetic material. In one embodiment, the leaflet assembly may include a wire form where a formed wire structure is used in conjunction with stabilized tissue to create a leaflet support structure, which can have anywhere from 1, 2, 3 or 4 leaflets, or valve cusps disposed therein. In another embodiment, the leaflet assembly can be wireless and use only the stabilized tissue and stent body to provide the leaflet support structure, and which can also have anywhere from 1, 2, 3 or 4 leaflets, or valve cusps disposed therein.


The upper cuff portion may be formed by heat-forming a portion of a tubular nitinol structure (formed from, for example, braided wire or a laser-cut tube) such that the lower portion retains the tubular shape but the upper portion is opened out of the tubular shape and expanded to create a widened collar structure that may be shaped in a variety of functional regular or irregular funnel-like or collar-like shapes.


A prosthetic mitral valve can be anchored to the heart at a location external to the heart via one or more tethers coupled to an anchor device, as described herein. For example, the tether(s) can be coupled to the prosthetic mitral valve and extend out of the heart and be secured at an exterior location (e.g., the epicardial surface) with an anchor device, as described herein. An anchor device can be used with one or more such tethers in other surgical situations where such a tether may be desired to extend from an intraluminal cavity to an external anchoring site.



FIG. 1 is a cross-sectional illustration of the left ventricle LV and left atrium LA of a heart having a transcatheter prosthetic mitral valve PMV deployed therein and an epicardial anchor device EAD securing the prosthetic mitral valve PMV in place. FIG. 1 illustrates the prosthetic mitral valve PMV seated into the native valve annulus NA and held there using an atrial cuff AC of the prosthetic mitral valve PMV, the radial tension from the native leaflets, and a ventricular tether T secured with attachment portions Tp to the prosthetic mitral valve PMV and to the epicardial anchor EAD. The apparatus and methods described herein can be used in conjunction with the various different types and embodiments of an epicardial anchor device, such as those described in pending International Patent Application No. PCT/2014/049218 entitled “Epicardial Anchor Devices and Methods,” (“PCT application '049218”) the disclosure of which is incorporated herein by reference in its entirety.



FIG. 2A is a schematic illustration of an alignment device, according to an embodiment. An alignment device 100 includes a needle assembly 120, a tube assembly 130 and an imaging probe 140. The tube assembly 130 includes an outer tube member 122 and an imaging element coupling member 124 coupled to a distal end portion of the outer tube member 122. The needle assembly 120 is movably received at least partially within a lumen defined by the outer tube member 122. The needle assembly 120 includes a needle tube 126 and an elongate needle 128 that is at least partially movably received through a lumen of the needle tube 126. The elongate needle 128 includes a distal tip or stylet 129 (shown in FIG. 2B) configured to pierce through tissue.


The imaging probe 140 is coupled to the outer tube member 122 and/or the imaging element coupling member 124. The imaging probe 140 includes an elongate cable 132 coupled on a proximal end to a handle assembly 136 and having on a distal end portion an imaging component 134. The distal end portion and imaging element 134 can be coupled to the imaging element coupling member 124 of the tube assembly 130. The cable 132 electrically and operatively couples the imaging element 134 to control components (not shown) included in the handle 136. In some embodiments, the imaging probe 140 can be, for example, an 8 or 10 French Acuson AcuNav™ device that is coupled to the outer tube member 122. The imaging element 134 can include one or more ultrasound transducers. In some embodiments, the imaging element 134 can include a side-looking 64-element phased array transducer with 4-way steerability, can operate at a frequency ranging from about 5.0-8.5 MHz or about 5.0-7.0 MHz, and/or provide greyscale imaging, color doppler imaging, tissue imaging, and/or 3D localization with Cartosound. In other embodiments, the imaging probe can be, for example, a known probe such as the UltraICE device from Boston Scientific, the EP Med View Flex catheter or ClearICE from St. Jude Medical, or the SoundStar from Biosense-Webster, or functionally similar to any one of these example imaging devices. Such a known imaging probe can be coupled to the tube assembly 130 as described above.


The handle 136 can be operatively coupleable to a computer device 138 that includes, for example, a display device (e.g., a computer monitor) such that image data collected by the imaging element 134 can be collected and stored within a memory of the computer device 138 and can be viewed on the display device. In some embodiments, an additional sleeve member (not shown in FIG. 2) is also included. In such an embodiment, a portion of the cable 132 and a portion of the outer tube member 122 can be received within a lumen of the sleeve member as described and shown with reference to the embodiment illustrated in FIGS. 3 and 4.


The alignment device 100 can be used in conjunction with a prosthetic intracardiac delivery device to facilitate the alignment and positioning of an intracardiac device such as, for example, a prosthetic mitral valve. The alignment device 100 can be used to determine a desired or optimal location on the epicardial surface to place an epicardial pad to secure a tether attached to a prosthetic valve as described in more detail below. The alignment device 100 can also be used to provide image data of the heart such that the commissural-commissural (C-C) plane or axis and the apical-posterior (A-P) plane or axis of the mitral valve and the annular region of the heart can be identified. This information can then be used to position and align a prosthetic mitral device in a desired location and orientation as described in more detail below with reference to specific embodiments. Thus, during a procedure, after using the alignment device 100, a prosthetic mitral valve can be deployed within the left atrium of the heart and a tether coupled to the prosthetic mitral valve and extending outside the heart can be aligned and secured at a desired location with an epicardial pad device.



FIG. 2B is a schematic illustration of a portion of the alignment device 100 shown in use to image a heart H. In use, the coupling member 124 is placed near or in contact with the epicardial surface ES of the heart near, for example, the apex of the heart. The imaging element 134 (not shown in FIG. 2B) of the imaging probe 140 can then be used to image the heart to determine an alignment path for a tether attached to the prosthetic valve such that an initial desired location on the apex of the epicardial surface to anchor the tether with an epicardial pad can be determined. For example, images up through the heart can be taken, and the image data can be used to determine an alignment path between the location of the native mitral valve NMV (e.g., a centerline of the mitral valve) and the apex of the heart at the epicardial surface ES. The alignment path can be used to align the tether with the centerline of the native mitral valve and can also be used to guide the needle assembly 120 along the trajectory of the alignment path during a procedure to deploy the prosthetic mitral valve. Using the image data, an optimal or desired location to secure the tether to the epicardial surface can be determined. For example, the optimal location can be substantially perpendicular to the alignment path, which is perpendicular to the C-C plane (described below). Specifically, the imaging probe 140 can produce image data such that the C-C plane and the A-P plane can be identified. For example, alignment device 100 can be placed in a first orientation relative to the heart and first image data can be collected and stored and displayed on the computer device 138. The alignment device 100 can then be rotated, for example, 90 degrees and second image data can be obtained. From this image data, the C-C plane and the A-P plane of the mitral valve and annular region of the heart can be identified. For example, the C-C plane can be identified in the first image data and the A-P plane can be identified in the second image data. For example, the image data can be displayed on a display device of the computer device and a user (e.g., physician) can visually identify the location of the C-C plane/axis and A-P plane/axis. Using the image data produced by the alignment device 100, the user can project an alignment path that is, for example, perpendicular to the C-C plane, and the alignment path can be used to determine the optimal or desired location to secure the tether of a prosthetic mitral valve at the epicardial surface of the heart (e.g., at the apex).



FIGS. 16 and 17 are each an example screenshot of an ultrasound image of the heart that can be produced using the alignment device 100. FIG. 16 is a C-C, mid-esophageal two-chamber view of the heart, produced, for example, with the alignment device positioned at a first orientation relative to the heart. FIG. 17 is an A-P, mid-esophageal long axis view of the heart, produced, for example, with the alignment device 100 positioned at a second orientation relative to the heart 90 degrees from the first orientation. As shown in FIGS. 16 and 17, the C-C plane and the A-P plane can be visually identified and an alignment path 135 can be projected onto the images (e.g., manually by the user) or the user can visually determine an alignment path to use. The alignment path 135 can extend between the C-C plane and the atrioventricular plane of the heart. As shown in FIGS. 16 and 17, the alignment path 135 extends through approximately the center of the native mitral valve NMV. As described above, the alignment path 135 can be used to determine a location to secure a tether of a prosthetic mitral valve to the epicardial surface such that the tether is aligned substantially perpendicular to the C-C plane and the prosthetic mitral valve is perpendicular to the C-C plane.


After the alignment device 100 has been used to obtain the desired image data, and the alignment path (and initial epicardial pad location) and the coordinates for the C-C plane and the A-P plane have been determined, the needle assembly 120 can be moved distally within the outer tube member 122 such that the distal piercing tip 129 of the elongate needle pierces through the epicardial surface at the desired pad location (e.g., determined with the image data described above). The needle assembly 120 can be extended within the left ventricle of the heart along the trajectory of the alignment path. For example, the distal tip 129 of the elongate needle 128 can be disposed distal of the needle tube 126 such that as the needle assembly 120 is moved distally through the outer tube member 122, the distal tip 129 can pierce the epicardial surface and pass through the wall of the heart and within the left ventricle. The elongate needle 128 of the needle assembly 120 can then be removed leaving the needle tube 126 within the heart and extended within the left ventricle. A guidewire (not shown) can then be inserted through the needle tube 126 and positioned within the heart. The needle tube 126 can then be removed from the heart, and the alignment device 100 removed from the patient's body. A prosthetic mitral valve (not shown in FIGS. 2A and 2B) can then be deployed within the atrium using a prosthetic valve delivery device as described in more detail below. The identified C-C plane and A-P plane can then be used to position and align the prosthetic mitral valve and to secure a tether coupled to the prosthetic mitral valve to the epicardial surface using an epicardial pad device.



FIGS. 3 and 4 are each a perspective view of an alignment device 200 according to an embodiment. The alignment device 200 can include the same or similar features and can function the same as or similar to the alignment device 100 and can be used to perform the same or similar procedures as described above for alignment device 100. The alignment device 200 includes a tube assembly 230, a needle assembly 220 and an imaging probe 240. The tube assembly 230 includes an outer tube member 222 and an imaging element coupling member 224 (also referred to herein as “coupling member”) coupled to a distal end of the outer tube member 222. The needle assembly 220 is movably received at least partially within a lumen defined by the outer tube member 222 and includes a needle tube 226 and an elongate needle (not shown in FIGS. 3 and 4) that includes a piercing distal tip or stylet (not shown) and an end cap 256 on a proximal end. As shown in FIGS. 3 and 4, the elongate needle and distal tip are retracted within the needle tube 226 and therefore are not visible. The needle assembly 222 includes a needle coupler 250 that can be used to tighten the needle tube 226 to the elongate needle to control or prevent movement of the elongate needle within the needle tube 226 as desired. For example, the needle coupler 250 can have a threaded attachment such that it can be rotated to tighten or loosen the needle tube 226. The needle coupler 250 can be, for example, a luer type connector. A hemostasis valve 252 is coupled to the outer tube member 222 and can be used to prevent bleeding back through the needle system during a procedure. The tube assembly 230 includes a luer connector 254 that is coupled to the outer tube member 222 and is configured to control or prevent movement of the needle assembly 220 within the outer tube member 222 as desired. The imaging element coupling member 224 defines a hole (not shown) through which the elongate needle and distal piecing tip of the needle assembly 222 can pass through and exit the distal end of the alignment device 200.


The imaging probe 240 includes a cable 232 coupled to a handle assembly 236, and an imaging element 234 coupled to a distal end portion of the cable 232. The imaging probe 240 can be the same as or similar to the imaging probe 140 described above. For example, the imaging probe 240 can be a known imaging probe that can be coupled to the tube assembly 230. Similarly, the cable 232, handle assembly 236, and imaging element 234 can each be the same as or similar to, and can provide the same as or similar function as the cable 132, handle assembly 136, and imaging element 134, respectively, described above. In this embodiment, the imaging probe 240 also includes an outer sheath 241 covering a portion of the cable 232 and a distal end portion of the cable 232 forms a targeting loop 242. In use, the targeting loop 242 is configured to contact the epicardial surface of a heart as described in more detail below. The distal end portion of the targeting loop 242 is coupled to the imaging element coupling member 224 and the imaging element 234 (shown in FIG. 4) is coupled to a distal end portion of the targeting loop 242. A screw 243 or other fastener can be used to secure the cable 232 and the imaging element 234 to the imaging element coupling member 224. In this embodiment, a portion of the cable 232 within the outer sheath 241 and a portion of the outer tube member 222 are disposed within a lumen of an outer sleeve component 244.


As with the previous embodiment, the cable 232 electrically and operatively couples the imaging element 234 to control components (not shown) included in the handle 236. As with the previous embodiment, the handle 236 can be operatively coupleable to a computer device (not shown) as described above. For example, the handle 236 includes a connection portion 246 that can be used to electrically couple the imaging probe 240 to a computer device.


As described above for alignment device 100, alignment device 200 can be used during a procedure to deploy a prosthetic heart device, such as, a prosthetic mitral valve. In use, the targeting loop 242 and imaging element coupling member 224 are placed near or in contact with the epicardial surface of the heart. The imaging element 234 of the imaging probe 240 can then be used to image the heart to determine an alignment path for a tether attached to the prosthetic valve such that an initial desired location on the apex of the epicardial surface to anchor the tether with an epicardial pad can be determined as described above for alignment device 100. The imaging probe 240 can also produce image data such that the C-C plane and the A-P plane can be identified as described above.


Also as described above, after the alignment device 200 has been used to obtain the desired image data, and the alignment path (and initial epicardial pad location) and the coordinates for the C-C plane and the A-P plane have been determined, the needle assembly 220 can be moved distally within the outer tube member 222 such that the distal piercing tip of the elongate needle pierces through the epicardial surface at the desired pad location (e.g., determined with the image data described above), and extends to the left ventricle of the heart. For example, the distal tip of the elongate needle can be disposed distal of the needle tube 226 such that as the needle assembly 220 is moved distally through the outer tube member 222, the distal tip can pierce the epicardial surface and pass through the wall of the heart and within the left ventricle. The elongate needle of the needle assembly 220 can then be removed leaving the needle tube 226 within the heart and extended within the left ventricle. A guidewire (not shown) can then be inserted through the needle tube 226 and positioned within the heart. The needle tube 226 can then be removed from the heart, and the alignment device 200 removed from the patient's body. A prosthetic mitral valve can then be deployed within the atrium using a prosthetic valve delivery device as described in more detail below. In some embodiments, a dilator device (not shown) can be used prior to inserting a delivery device to enlarge the opening at the epicardial surface. The identified C-C plane and A-P plane can then be used to position and align the prosthetic mitral valve and to secure a tether coupled to the prosthetic mitral valve to the epicardial surface using an epicardial pad device.



FIG. 5A illustrates a prosthetic mitral valve 360 deployed within the mitral annulus in an atrium of a heart and an intraventricular tether 362 (also referred to as “tether”) coupled to the prosthetic mitral valve 360 extending through the ventricle exiting an apical aperture and anchored to the epicardial surface with an epicardial pad device 364. In this example, such a prosthetic valve 360 is a compressible self-expanding transcatheter valve and includes a valve lumen 366, a prosthetic valve atrial cuff 368 and a valve body 370. However, it should be understood that the alignment devices described herein can be useful for various other surgical or interventional medical procedures, and particularly for procedures involving the deployment of intracardiac devices. As shown in FIG. 5A, in this example, intraventricular tether 362 is shown as perpendicular to a plane of the epicardial pad device 364 at the point of contact with the epicardial surface, and to the placement of the prosthetic valve.


In procedures involving the deployment of prosthetic mitral valves, having the valve properly seated within the native annulus helps prevent regurgitant leaking. Unlike some known prosthetic valves, a self-expanding prosthetic valve 360 as shown in FIG. 5A does not need to be sewn into place. Historically, in the first generation of artificial valves, such valves were delivered during open heart surgery and the native valve leaflets would be cut away, and a prosthetic valve sewn into place. In such approaches, however, complications can arise from open surgery and sternotomies. Second generation valves were delivered by a cardiac interventionalist, not a surgeon, using a catheter, and required balloon expansion, and were also sewn into place using endoscopic/catheter-based techniques. Third generation valves are characterized by being constructed of self-expanding martensidic/austenitic materials that did not require to be sewn into place. This avoided the problems associated with cardiac remodeling caused by sewing a rigid prosthetic to a dynamic tissue. However, tethering and seating these valves became of utmost importance to avoid leaking during systole.


Proper alignment of prosthetic valves in the C-C commissural plane/axis and the A-P anterior-posterior plane/axis can reduce and/or avoid perivalvular leakage around such prosthetic valves. However, the mitral valve is known to have a highly complex three-dimensional shape, namely a hyperbolic paraboloid, or more commonly, the shape of a well-known stackable potato chip. Another problem concerns LVOT obstruction. Prosthetic valves that apply significant lateral pressure against the anterior portion of the annulus can cause obstruction of the aortic flow exiting the left ventricle because the mitral annulus and the aorta share a common wall at the anterior segment of the mitral valve. The consequence of this is that sealing against perivalvular leaking while avoiding LVOT can be a challenge. Thus, fourth generation devices have implemented an asymmetric design to accommodate the seating of the prosthetic valve into the native annulus, while at the same time eliminating the lateral annular pressure that causes LVOT obstruction. But this raises another issue, namely, that the prosthetic valve, now asymmetric, must be deployed so that the axis of the valve features is in alignment with the axis of the mitral annulus.


Referring now to FIG. 5B, which is a schematic illustration showing the commissural-commissural (C-C) plane/axis, labeled P1, the apical lateral plane/axis, labeled P2, the anterior-posterior plane/axis, labeled P3, and the apical longitudinal plane/axis, labeled P4. As shown, in this example, the plane/axis P1 is substantially parallel to the plane/axis P2 such that tether 362 intersects both the plane/axis P1 and the plane/axis P2 at substantially 90 degree angles. The plane/axis P3 is also shown to be substantially parallel to the plane/axis P4. The angles alpha α (between tether 362 and plane/axis P1), beta β (between tether 362 and P2), gamma γ (between tether 362 and P3), and delta δ (between tether 362 and P4), can vary, for example, according to ranges of 85 to 95 degrees, 80 to 100 degrees, and 75 to 105 degrees. The angle relationship between the planes/axis P1 and the plane/axis P2, and the angle relationship between the plane/axis P3 and the plane/axis P4 can also vary accordingly from being parallel as shown, depending on the particular anatomy encountered with a given patient.



FIGS. 6A-6D illustrate a series of schematic sectional views showing the prosthetic valve and tether deployed within the heart. FIG. 6A shows a prosthetic mitral valve 360 deployed within the mitral annulus in the atrium of the heart and the intraventricular tether 362 extending through the floor/apex 372 of the ventricle. FIG. 6B shows an epicardial view showing the epicardial pad 364 affixed to the apical surface of the heart, and the tether 362 coupled to the pad 364 through the ventricle. FIG. 6C shows a view of the left ventricle showing the bottom of the prosthetic valve body 370 that is deployed in the native annulus, and the tether 362 extending intraventricularly away from valve 360 towards the apex 372 and pad 364. FIG. 6D is an apical view of the heart showing the epicardial pad 364 affixed to the epicardial surface with the tether 362 tied off and trimmed.



FIG. 7 is a cross-sectional side view illustration of the intended final alignment of the deployed valve 360. FIG. 7 shows the ventricular wall in cross-section with a sight-line S with point A-to-point B extending from the ventricular apex 372 along tether 362 towards the atrium and commissural plane/axis P1. The angle, beta (3, near the apex 372 is shown as one of the useable angles for maximizing the anti-leaking property of the properly deployed valve 360. Another benefit, aside from preventing leakage, is reducing or preventing tissue damage at the apex 372.



FIGS. 8-12 illustrate an alignment device according to another embodiment. An alignment device 400 can include some or all of the same or similar features, and can function the same as or similar to, the alignment devices 100, 200 or 300 described above, and can be used to perform the same or similar procedures. The alignment device 400 includes a tube assembly 430, a needle assembly 420 and an imaging probe 440. The tube assembly 430 includes an outer tube member 422 and an imaging element coupling member 424 coupled to a distal end of the outer tube member 422. The needle assembly 420 is movably received at least partially within a lumen defined by the outer tube member 422 and includes a needle tube 426 and an elongate needle 428 (see FIG. 11) that includes a piercing distal tip or stylet 429 and an end cap 456 on a proximal end. The needle assembly 422 also includes a needle coupler 450 that can be used to tighten the needle tube 426 to the elongate needle 428 to control or prevent movement of the elongate needle 428 within the needle tube 426 as desired. For example, the needle coupler 450 can have a threaded attachment such that it can be rotated to tighten or loosen the needle tube 426. The needle coupler 450 can be, for example, a luer type connector. A hemostasis valve 452 is coupled to the outer tube member 422 and can be used to prevent bleeding back through the alignment device 400 during a procedure. The tube assembly 430 includes a luer connector 454 that is coupled to the outer tube member 422 and is configured to control or prevent movement of the needle assembly 420 within the outer tube member 422 as desired. The imaging element coupling member 424 defines a hole 427 (see, e.g., FIG. 12) through which the elongate needle 428 and distal piecing tip 429 of the needle assembly 422 can pass and exit the distal end of the alignment device 400.


The imaging probe 430 includes a cable 432 coupled to a handle assembly 436, and an imaging element 434 (e.g., one or more transducers) coupled to a distal end portion of the cable 432. The imaging probe 440 can be the same as or similar to the imaging probes 140 and 240 described above. For example, the imaging probe 440 can be a known imaging probe that can be coupled to the tube assembly 430. Similarly, the cable 432, handle assembly 436, and imaging element 434 can each be the same as or similar to, and can provide the same as or similar function as the cable 132, handle assembly 136 and imaging element 134, respectively, described above for previous embodiments. The distal end portion of the cable 432 with the imaging element 434 is coupled to the imaging element coupling member 424 as shown, for example, in FIG. 12. For example, the distal end portion of the cable 432 can be received within a groove 425 defined by the imaging element coupling member 424. A pair of screws 443 or other fasteners can be used to secure the cable 432 and imaging element 434 to the imaging element coupling member 424.


As with the previous embodiments, the cable 432 electrically and operatively couples the imaging element 434 (transducer(s)) to control components (not shown) included in the handle 436. Also as with the previous embodiments, the handle 436 can be operatively coupleable to a computer device (not shown) as described above. For example, the handle 436 includes a connection portion 446 that can be used to electrically couple the imaging probe 440 to a computer device.


As described above for alignment devices 100 and 200, alignment device 400 can be used during a procedure to deploy a prosthetic heart device, such as, a prosthetic mitral valve. In use, the imaging element coupling member 424 is placed near or in contact with the epicardial surface of the heart. The imaging element 434 of the imaging probe 440 can then be used to image the heart such that the image data collected can be used to determine an initial desired location to secure a tether attached to the prosthetic mitral valve at the epicardial surface with an epicardial pad, and the C-C plane/axis and the A-P plane/axis can be identified. For example, the image data can be displayed on a display device of the computer device and the C-C plane and A-P plane can be viewed by a user. After the alignment device 400 has been used to obtain the desired image data, and the location for the epicardial pad and the coordinates for the C-C plane and the A-P plane have been determined, the needle assembly 420 can be moved distally within the outer tube member 422 such that the distal piercing tip of the elongate needle pierces through the epicardial surface and extends within the left ventricle of the heart. For example, the distal tip of the elongate needle can be disposed distal of the needle tube 426 such that as the needle assembly 420 is moved distally through the outer tube member 422, the distal tip can pierce the epicardial surface and pass through the wall of the heart. The elongate needle can then be removed leaving the needle tube 426 within the heart and extended within the left ventricle to the native mitral valve. A guidewire (not shown) can then be inserted through the needle tube 426 and positioned within the heart. The guidewire can be advanced through the atrium and anchored to a suitable location within the heart, such as, for example, to the pulmonary vessel area. A balloon can be used in conjunction with the guidewire to avoid having the guidewire interfere with the chordae tendineae, which are found in the ventricle below the mitral valve. The needle tube 426 can then be removed from the heart, and the alignment device 400 removed from the patient's body. A prosthetic mitral valve can then be deployed within the atrium using a prosthetic valve delivery device as described in more detail below. The identified C-C plane and A-P plane can then be used to position and align the prosthetic mitral valve and to secure a tether coupled to the prosthetic mitral valve to the epicardial surface using an epicardial pad device.



FIG. 13 is a flowchart illustrating a method of deploying and aligning a prosthetic valve within a heart using an alignment device as described herein. At 573, a distal end portion of an alignment device as described herein is positioned near or in contact with an epicardial surface of a heart. At 574, the heart is imaged using an imaging element of the alignment device to identify the C-C plane and A-P plane of the mitral valve and annular region of the heart. At 575, a needle assembly of the alignment device is inserted through the epicardial surface and extended within the left ventricle. At 576, an elongate needle of the alignment device is removed leaving a needle tube disposed within the heart. At 577, a guidewire is inserted into the needle tube and a distal end is positioned or anchored to tissue at or near the C-C plane of the native mitral valve. For example, the guidewire can be anchored to, for example, the pulmonary vessel area. At 578, with the guidewire in position in the heart, the alignment device can be removed. At 579, a prosthetic valve delivery device is inserted over the guidewire and into the atrium of the heart to deploy a prosthetic mitral valve at the mitral annulus. At 580, the prosthetic mitral valve is positioned using the C-C plane and A-P plane coordinates determined by the imaging data produced by the alignment device. At 581, a tether attached to the prosthetic mitral valve is secured at an apical site on the epicardial surface with an epicardial pad.



FIG. 14 is a flowchart illustrating another method of deploying a prosthetic valve using an alignment device as described herein in conjunction with a prosthetic valve delivery device. At 682, the initial epicardial pad location is identified using an alignment device as described herein. At 683, the commissural-commissural (C-C) axis and anterior-posterior (A-P) axis of the mitral valve and annular region are identified. At 684, the proper axis of insertion is identified and the needle assembly is moved distally through the tube assembly (e.g., 130, 230, 430) and through the apical ventricular wall. At 685, the elongate needle of the needle assembly is removed, leaving the needle tube in position within the heart, and a guidewire is inserted through the needle tube and into the ventricle, and extended to the atrium. A balloon can optionally be used to avoid having the guidewire interfere with the chordae tendinae, which are found in the ventricle below the mitral valve. At 686, the guidewire is extended up through the atrium and anchored to a suitable location such as the pulmonary vessel area, and the balloon is removed. A dilator can be inserted onto the wire and into the ventricle. At 687, purse string sutures can be attached to the identified apical access site on the epicardial surface. At 688, a catheter (e.g., valve delivery device) is inserted into the atrium. The catheter is loaded with a prosthetic valve, such as a self-expanding tethered cuffed valve described herein. At 689, the compressed (compressed within the catheter or delivery capsule) self-expanding asymmetric transcatheter valve is deployed into the mitral annulus. At 690, an echoradiography or other suitable imaging technique can be used to position the asymmetric valve using the C-C and A-P axis coordinates, which can ensure that the flat(ter) portion of the valve cuff is oriented towards the A2 leaflet and any anti-leakage cuff features are placed within the commissures. At 691, the deployment device catheter and the guidewire can be removed. The tether that is attached to the prosthetic valve can provide a longitudinal sealing force towards the apex, and the tether can be secured to an epicardial pad device at the apical site. In some embodiments, a vacuum low pressure may be applied to provide a temporary positioning seal to affix the probe against the epicardial surface and maintain a correct location once the correct epicardial location is identified under radiography



FIG. 15 is a schematic illustration of a kit according to an embodiment. In some embodiments, a surgical kit 792 can include an alignment device 700 which can be, for example, an alignment device as described herein (e.g., alignment device 100, 200, 400) and a transcatheter prosthetic valve delivery device 793 both disposed within a sterile package 794. In some embodiments, the kit 792 can further include a transcatheter valve 760 (e.g., a prosthetic mitral valve) and/or an epicardial pad 764 that can be used to secure the transcatheter valve 760 in position within the heart. The kit 792 can also include other optional components such as, for example, a guidewire and/or a dilator device (each not shown in FIG. 15).


An epicardial pad device (also referred to as “pad” or “pad device”) as described herein may be a common pledget or similar device, or can be a device having multiple sub-components. In one embodiment, the epicardial pad device may include a flexible pad for contact with the epicardial surface, a sleeve gasket, and a rigid suturing disk as described, for example, in PCT application '049218 incorporated by reference above. Such a flexible pad is intended for contacting the epicardial surface and may be constructed of any suitable biocompatible surgical material. The pad functions to assist sealing of the surgical puncture. In some embodiments, the pad device can be made at least in part of a double velour material to promote ingrowth of the pad into the puncture site area. Pads, or felt pledgets, are commonly made of a felted polyester and may be cut to any suitable size or shape, such as those available from Bard® as PTFE Felt Pledgets having a nominal thickness of 2.87 mm. In some embodiments, the pad is larger in diameter than the rigid suturing disk (as described in PCT application '049218.


The sleeve gasket can function to seal any gap or leakage that may occur between the pad and the suturing disk. The sleeve gasket is made of a flexible material so that it can be compressed when the disk and/or pad are tightened against the puncture site, e.g. against the ventricular wall. The sleeve gasket may be connected to the pad and the disk as an integral assemblage, or the components may be separately slid onto the suturing tether, in order, and then tightened against the puncture site, e.g. ventricular wall. The sleeve gasket can function to prevent hemodynamic leakage that may flow along the path of the axially located suturing tether. Such anchoring tethers are used in deployment of prosthetic heart valves and typically extend from within the lumen of the organ being anchored, e.g. the heart, to the external anchoring location, e.g. the epicardial surface. Such epicardial pads may also be used to anchor one or more suturing tethers in other surgical situations where such tether(s) is required to extend from an intraluminal cavity to an external anchoring site.


The rigid suturing disk can function to provide the anchoring and mounting platform to which one or more suturing tethers may be tied. The disk may be made of any suitable biocompatible material. In some embodiments, the disk is made of polyethylene, or other hard or semi-hard polymer, and is covered with a polyester velour to promote ingrowth. In other embodiments, it is made of metal such as Nitinol®, or ceramic materials. The disk can range in size depending on the particular need. In some embodiments, the size of the disk can range from 1.0-3.0 cm in diameter. In other embodiments, the size of the disk ranges from 0.2-5.0 cm; the larger size not necessarily for intraventricular anchoring but for other surgical use, e.g. hernia repair, gastrointestinal repairs, etc.


One benefit of using a disk as described above to capture and anchor a suture is that, unlike suture anchors that bore into tissue with screws or barbs, there is little or no trauma to the tissue at the site of the anchor. Further, using a disk, which quickly slides over the tether, instead of stitches, allows for the effective permanent closure of large punctures. Surgically closing large punctures by sewing takes time and is difficult. When closing a puncture in the heart, adding the difficulty of requiring a surgeon to sew the puncture closed can increase the likelihood of life threatening complications to the patient. This is especially so in situations where a prosthetic heart valve is delivered and deployed without opening the chest cavity using transcatheter technologies. Sewing a ventricular puncture closed in this situation is typically not tenable.


The disk may also have a channel on its sidewall to allow the tether to be wound around the disk to improve anchoring. This radial channel functions to allow a user to quickly capture and seat a suture tether that is intended to be anchored. A winding channel allows a user to quickly wind suture tether(s) around the disk. Using the winding channel in conjunction with the radial channel(s) allows a user to quickly anchor the suture, while permitting the user to unwind and recalibrate so that the tether tension is appropriate for the particular situation. In some embodiments, a suture that anchors a transcatheter valve will have about 2 lbs. of longitudinal force.


In one embodiment, the tether extends through the flexible pad, sleeve gasket, and rigid suturing disk, and the pad device is applied to the puncture site and makes contact with the epicardial surface. The tether may be trimmed after it is affixed to the disk. In another embodiment, the pad device has a locking pin. The locking pin functions to hold the suturing tether in place after the disk is tightened against the ventricular wall by piercing the tether as it travels axially through the disk. A locking pin hole on the disk allows the locking pin to laterally intersect and affix the longitudinally disposed suturing tether. In another embodiment, the anti-leakage sleeve is unnecessary and not included. In yet another embodiment, the flexible pad is unnecessary and not included. In another embodiment, the suturing disk may have an axial tunnel or aperture which is tapered to allow the suture to be easily threaded into the axial tunnel and to reduce lateral cutting force of the disk against the suture.


While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above


Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described.

Claims
  • 1. An apparatus, comprising: a handle assembly;a tube assembly including an outer tube member defining a lumen and a coupling member coupled to a distal end portion of the outer tube member;a needle assembly configured to be received through the lumen of the outer tube member, the needle assembly including an elongate needle having a distal tip configured to be inserted through the epicardial surface of a heart and extend within the left ventricle of the heart; andan imaging probe coupled to the coupling member, the imaging probe including a cable and an imaging element disposed at, and directly coupled to, a distal end portion of the cable, the imaging probe configured to provide image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of the mitral valve and the annular region of the heart such that a prosthetic mitral valve can be deployed and positioned within the heart based at least in part on the C-C plane and the A-P plane,wherein the cable includes a proximal end portion coupled to the handle assembly and an intermediate portion extending between the proximal end portion and the distal end portion, the intermediate portion of the cable being positioned within the outer tube member, the distal end portion of the cable exiting a distal end of the outer tube member so that the distal end portion of the cable of the imaging probe forms a targeting loop configured to contact a portion of the epicardial surface to help stabilize the needle assembly when inserted into the heart, the targeting loop configured to define an aperture through which the elongate needle is configured to travel.
  • 2. The apparatus of claim 1, wherein the imaging element of the imaging probe includes at least one ultrasound transducer.
  • 3. The apparatus of claim 1, wherein the imaging element of the imaging probe includes a side-looking multi-element phased array transducer.
  • 4. The apparatus of claim 3, wherein the phased-array transducer is configured to operate at a frequency ranging from about 5.0 to about 8.5 MHz.
  • 5. The apparatus of claim 3, wherein the phased-array transducer is configured to provide at least one of greyscale imaging, color doppler imaging, tissue imaging, or 3D localization.
  • 6. The apparatus of claim 1, wherein the imaging probe is configured to provide multi-direction steerability.
  • 7. The apparatus of claim 1, further comprising: a prosthetic valve delivery device configured to deploy and align the prosthetic mitral valve within the heart, the alignment of the prosthetic mitral valve being based at least in part on the C-C plane and the A-P plane determined by the image data.
  • 8. The apparatus of claim 7, further comprising: a self-expanding prosthetic mitral valve disposable within a lumen of the delivery device.
  • 9. The apparatus of claim 7, further comprising: an epicardial pad, the epicardial pad configured to be secured to a tether coupled to the prosthetic mitral valve extending outside the epicardial surface of the heart when the prosthetic mitral valve has been deployed within the heart.
  • 10. The apparatus of claim 7, wherein the needle assembly includes a needle tube defining a lumen, the apparatus further comprising: a guidewire configured to be received through the lumen of the needle tube and advanced into the left ventricle of the heart; anda dilator configured to be disposed over the guide wire and inserted into the left ventricle of the heart.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation under 35 USC Section 120 of International Application No. PCT/US2014/061046, filed Oct. 17, 2014, entitled “Apparatus and Methods for Alignment and Deployment of Intracardiac Devices,” which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/892,390, filed Oct. 17, 2013, entitled “Apical ICE Echo Probe,” each of the disclosures of which is incorporated herein by reference in its entirety.

US Referenced Citations (769)
Number Name Date Kind
2697008 Rowley Dec 1954 A
3409013 Berry Nov 1968 A
3472230 Fogarty et al. Oct 1969 A
3476101 Ross Nov 1969 A
3548417 Kisher Dec 1970 A
3587115 Shiley Jun 1971 A
3657744 Ersek Apr 1972 A
3671979 Moulopoulos Jun 1972 A
3714671 Edwards et al. Feb 1973 A
3755823 Hancock Sep 1973 A
3976079 Samuels et al. Aug 1976 A
4003382 Dyke Jan 1977 A
4035849 Angell et al. Jul 1977 A
4056854 Boretos et al. Nov 1977 A
4073438 Meyer Feb 1978 A
4106129 Carpentier et al. Aug 1978 A
4222126 Boretos et al. Sep 1980 A
4265694 Boretos et al. May 1981 A
4297749 Davis et al. Nov 1981 A
4339831 Johnson Jul 1982 A
4343048 Ross et al. Aug 1982 A
4345340 Rosen Aug 1982 A
4373216 Klawitter Feb 1983 A
4406022 Roy Sep 1983 A
4470157 Love Sep 1984 A
4490859 Black et al. Jan 1985 A
4535483 Klawitter et al. Aug 1985 A
4574803 Storz Mar 1986 A
4585705 Broderick et al. Apr 1986 A
4592340 Boyles Jun 1986 A
4605407 Black et al. Aug 1986 A
4612011 Kautzky Sep 1986 A
4626255 Reichart et al. Dec 1986 A
4638886 Marietta Jan 1987 A
4643732 Pietsch et al. Feb 1987 A
4655771 Wallsten Apr 1987 A
4692164 Dzemeshkevich et al. Sep 1987 A
4733665 Palmaz Mar 1988 A
4759758 Gabbay Jul 1988 A
4762128 Rosenbluth Aug 1988 A
4777951 Cribier et al. Oct 1988 A
4787899 Lazarus Nov 1988 A
4787901 Baykut Nov 1988 A
4796629 Grayzel Jan 1989 A
4824180 Levrai Apr 1989 A
4829990 Thuroff et al. May 1989 A
4830117 Capasso May 1989 A
4851001 Taheri Jul 1989 A
4856516 Hillstead Aug 1989 A
4878495 Grayzel Nov 1989 A
4878906 Lindemann et al. Nov 1989 A
4883458 Shiber Nov 1989 A
4922905 Strecker May 1990 A
4923013 De Gennaro May 1990 A
4960424 Grooters Oct 1990 A
4966604 Reiss Oct 1990 A
4979939 Shiber Dec 1990 A
4986830 Owens et al. Jan 1991 A
4994077 Dobben Feb 1991 A
4996873 Takeuchi Mar 1991 A
5007896 Shiber Apr 1991 A
5026366 Leckrone Jun 1991 A
5032128 Alonso Jul 1991 A
5035706 Giantureo et al. Jul 1991 A
5037434 Lane Aug 1991 A
5047041 Sammuels Sep 1991 A
5059177 Towne et al. Oct 1991 A
5064435 Porter Nov 1991 A
5080668 Bolz et al. Jan 1992 A
5085635 Cragg Feb 1992 A
5089015 Ross Feb 1992 A
5152771 Sabbaghian et al. Oct 1992 A
5163953 Vince Nov 1992 A
5167628 Boyles Dec 1992 A
5192297 Hull Mar 1993 A
5201880 Wright et al. Apr 1993 A
5266073 Wall Nov 1993 A
5282847 Trescony et al. Feb 1994 A
5295958 Shturman Mar 1994 A
5306296 Wright et al. Apr 1994 A
5332402 Teitelbaum Jul 1994 A
5336616 Livesey et al. Aug 1994 A
5344442 Deac Sep 1994 A
5360444 Kusuhara Nov 1994 A
5364407 Poll Nov 1994 A
5370685 Stevens Dec 1994 A
5397351 Pavcnik et al. Mar 1995 A
5411055 Kane et al. May 1995 A
5411552 Andersen et al. May 1995 A
5415667 Frater May 1995 A
5443446 Shturman Aug 1995 A
5480424 Cox Jan 1996 A
5500014 Quijano et al. Mar 1996 A
5545209 Roberts et al. Aug 1996 A
5545214 Stevens Aug 1996 A
5549665 Vesely et al. Aug 1996 A
5554184 Machiraju Sep 1996 A
5554185 Block et al. Sep 1996 A
5571175 Vanney et al. Nov 1996 A
5591185 Kilmer et al. Jan 1997 A
5607462 Imran Mar 1997 A
5607464 Trescony et al. Mar 1997 A
5609626 Quijano et al. Mar 1997 A
5639274 Fischell et al. Jun 1997 A
5662704 Gross Sep 1997 A
5665115 Cragg Sep 1997 A
5674279 Wright et al. Oct 1997 A
5697905 Ambrosio Dec 1997 A
5702368 Stevens et al. Dec 1997 A
5716417 Girard et al. Feb 1998 A
5728068 Leone et al. Mar 1998 A
5728151 Garrison et al. Mar 1998 A
5735842 Krueger et al. Apr 1998 A
5741333 Frid Apr 1998 A
5749890 Shaknovich May 1998 A
5756476 Epstein May 1998 A
5769812 Stevens et al. Jun 1998 A
5792179 Sideris Aug 1998 A
5800508 Goicoechea et al. Sep 1998 A
5833673 Ockuly et al. Nov 1998 A
5840081 Andersen et al. Nov 1998 A
5855597 Jayaraman Jan 1999 A
5855601 Bessler Jan 1999 A
5855602 Angell Jan 1999 A
5904697 Gifford, III et al. May 1999 A
5925063 Khosravi Jul 1999 A
5957949 Leonhardt et al. Sep 1999 A
5968052 Sullivan, III et al. Oct 1999 A
5968068 Dehdashtian et al. Oct 1999 A
5972030 Garrison et al. Oct 1999 A
5993481 Marcade et al. Nov 1999 A
6027525 Suh et al. Feb 2000 A
6042607 Williamson, IV et al. Mar 2000 A
6045497 Schweich, Jr. et al. Apr 2000 A
6063112 Sgro et al. May 2000 A
6077214 Mortier et al. Jun 2000 A
6099508 Bousquet Aug 2000 A
6132473 Williams et al. Oct 2000 A
6168614 Andersen et al. Jan 2001 B1
6171335 Wheatley et al. Jan 2001 B1
6174327 Mertens et al. Jan 2001 B1
6183411 Mortier et al. Feb 2001 B1
6210408 Chandrasakaran et al. Apr 2001 B1
6217585 Houser et al. Apr 2001 B1
6221091 Khosravi Apr 2001 B1
6231602 Carpentier et al. May 2001 B1
6245102 Jayaraman Jun 2001 B1
6260552 Mortier et al. Jul 2001 B1
6261222 Schweich, Jr. et al. Jul 2001 B1
6264602 Mortier et al. Jul 2001 B1
6287339 Vazquez et al. Sep 2001 B1
6299637 Shaolian Oct 2001 B1
6302906 Goecoechea et al. Oct 2001 B1
6312465 Griffin et al. Nov 2001 B1
6332893 Mortier et al. Dec 2001 B1
6350277 Kocur Feb 2002 B1
6358277 Duran Mar 2002 B1
6379372 Dehdashtian et al. Apr 2002 B1
6402679 Mortier et al. Jun 2002 B1
6402680 Mortier et al. Jun 2002 B2
6402781 Langberg et al. Jun 2002 B1
6406420 McCarthy et al. Jun 2002 B1
6425916 Garrison et al. Jul 2002 B1
6440164 Di Matteo et al. Aug 2002 B1
6454799 Schreck Sep 2002 B1
6458153 Bailey et al. Oct 2002 B1
6461382 Cao Oct 2002 B1
6468660 Ogle et al. Oct 2002 B2
6482228 Norred Nov 2002 B1
6488704 Connelly et al. Dec 2002 B1
6537198 Vidlund et al. Mar 2003 B1
6540782 Snyders Apr 2003 B1
6569196 Vesely et al. May 2003 B1
6575252 Reed Jun 2003 B2
6582462 Andersen et al. Jun 2003 B1
6605112 Moll Aug 2003 B1
6616684 Vidlund et al. Sep 2003 B1
6622730 Ekvall et al. Sep 2003 B2
6629534 St. Goar et al. Oct 2003 B1
6629921 Schweich, Jr. et al. Oct 2003 B1
6648077 Hoffman Nov 2003 B2
6648921 Anderson et al. Nov 2003 B2
6652578 Bailey et al. Nov 2003 B2
6669724 Park et al. Dec 2003 B2
6706065 Langberg et al. Mar 2004 B2
6709456 Langberg et al. Mar 2004 B2
6723038 Schroeder et al. Apr 2004 B1
6726715 Sutherland Apr 2004 B2
6730118 Spenser et al. May 2004 B2
6733525 Yang et al. May 2004 B2
6740105 Yodfat et al. May 2004 B2
6746401 Panescu Jun 2004 B2
6746471 Mortier et al. Jun 2004 B2
6752813 Goldfarb et al. Jun 2004 B2
6764510 Vidlund et al. Jul 2004 B2
6797002 Spence et al. Sep 2004 B2
6810882 Langberg et al. Nov 2004 B2
6830584 Seguin Dec 2004 B1
6854668 Wancho et al. Feb 2005 B2
6855144 Lesh Feb 2005 B2
6858001 Aboul-Hosn Feb 2005 B1
6890353 Cohn et al. May 2005 B2
6893460 Spenser et al. May 2005 B2
6896690 Lambrecht et al. May 2005 B1
6908424 Mortier et al. Jun 2005 B2
6908481 Cribier Jun 2005 B2
6936067 Buchanan Aug 2005 B2
6945996 Sedransk Sep 2005 B2
6955175 Stevens et al. Oct 2005 B2
6974476 McGuckin et al. Dec 2005 B2
6976543 Fischer Dec 2005 B1
6997950 Chawia Feb 2006 B2
7018406 Seguin et al. Mar 2006 B2
7018408 Bailey et al. Mar 2006 B2
7044905 Vidlund et al. May 2006 B2
7060021 Wilk Jun 2006 B1
7077862 Vidlund et al. Jul 2006 B2
7087064 Hyde Aug 2006 B1
7100614 Stevens et al. Sep 2006 B2
7101395 Tremulis et al. Sep 2006 B2
7108717 Freidberg Sep 2006 B2
7112219 Vidlund et al. Sep 2006 B2
7115141 Menz et al. Oct 2006 B2
7141064 Scott et al. Nov 2006 B2
7175656 Khairkhahan Feb 2007 B2
7198646 Figulla et al. Apr 2007 B2
7201772 Schwammenthal et al. Apr 2007 B2
7247134 Vidlund et al. Jul 2007 B2
7252682 Seguin Aug 2007 B2
7267686 DiMatteo et al. Sep 2007 B2
7275604 Wall Oct 2007 B1
7276078 Spenser et al. Oct 2007 B2
7276084 Yang et al. Oct 2007 B2
7316706 Bloom et al. Jan 2008 B2
7318278 Zhang et al. Jan 2008 B2
7326236 Andreas et al. Feb 2008 B2
7329278 Seguin et al. Feb 2008 B2
7331991 Kheradvar et al. Feb 2008 B2
7335213 Hyde et al. Feb 2008 B1
7374571 Pease et al. May 2008 B2
7377941 Rhee et al. May 2008 B2
7381210 Zarbatany et al. Jun 2008 B2
7381218 Schreck Jun 2008 B2
7393360 Spenser et al. Jul 2008 B2
7404824 Webler et al. Jul 2008 B1
7416554 Lam et al. Aug 2008 B2
7422072 Dade Sep 2008 B2
7429269 Schwammenthal et al. Sep 2008 B2
7442204 Schwammenthal et al. Oct 2008 B2
7445631 Salahieh et al. Nov 2008 B2
7462191 Spenser et al. Dec 2008 B2
7470285 Nugent et al. Dec 2008 B2
7500989 Solem et al. Mar 2009 B2
7503931 Kowalsky et al. Mar 2009 B2
7510572 Gabbay Mar 2009 B2
7510575 Spenser et al. Mar 2009 B2
7513908 Lattouf Apr 2009 B2
7524330 Berreklouw Apr 2009 B2
7527647 Spence May 2009 B2
7534260 Lattouf May 2009 B2
7556646 Yang et al. Jul 2009 B2
7579381 Dove Aug 2009 B2
7585321 Cribier Sep 2009 B2
7591847 Navia et al. Sep 2009 B2
7618446 Andersen et al. Nov 2009 B2
7618447 Case et al. Nov 2009 B2
7621948 Herrmann et al. Nov 2009 B2
7632304 Park Dec 2009 B2
7632308 Loulmet Dec 2009 B2
7635386 Gammie Dec 2009 B1
7674222 Nikolic et al. Mar 2010 B2
7674286 Alfieri et al. Mar 2010 B2
7695510 Bloom et al. Apr 2010 B2
7708775 Rowe et al. May 2010 B2
7748389 Salahieh et al. Jul 2010 B2
7766961 Patel et al. Aug 2010 B2
7789909 Andersen et al. Sep 2010 B2
7803168 Gifford et al. Sep 2010 B2
7803184 McGuckin, Jr. et al. Sep 2010 B2
7803185 Gabbay Sep 2010 B2
7806928 Rowe et al. Oct 2010 B2
7837727 Goetz et al. Nov 2010 B2
7854762 Speziali et al. Dec 2010 B2
7892281 Seguin et al. Feb 2011 B2
7896915 Guyenot et al. Mar 2011 B2
7901454 Kapadia et al. Mar 2011 B2
7927370 Webler et al. Apr 2011 B2
7931630 Nishtala et al. Apr 2011 B2
7942928 Webler et al. May 2011 B2
7955247 Levine et al. Jun 2011 B2
7955385 Crittenden Jun 2011 B2
7972378 Tabor et al. Jul 2011 B2
7988727 Santamore et al. Aug 2011 B2
7993394 Hariton et al. Aug 2011 B2
8007992 Tian et al. Aug 2011 B2
8029556 Rowe Oct 2011 B2
8043368 Crabtree Oct 2011 B2
8052749 Salahieh Nov 2011 B2
8052750 Tuval et al. Nov 2011 B2
8052751 Aklog et al. Nov 2011 B2
8062355 Figulla et al. Nov 2011 B2
8062359 Marquez et al. Nov 2011 B2
8070802 Lamphere et al. Dec 2011 B2
8109996 Stacchino et al. Feb 2012 B2
8142495 Hasenkam et al. Mar 2012 B2
8152821 Gambale et al. Apr 2012 B2
8157810 Case et al. Apr 2012 B2
8167932 Bourang et al. May 2012 B2
8167934 Styrc et al. May 2012 B2
8187299 Goldfarb et al. May 2012 B2
8206439 Gomez Duran Jun 2012 B2
8216301 Bonhoeffer et al. Jul 2012 B2
8226711 Mortier et al. Jul 2012 B2
8236045 Benichou et al. Aug 2012 B2
8241274 Keogh et al. Aug 2012 B2
8252051 Chau et al. Aug 2012 B2
8303653 Bonhoeffer et al. Nov 2012 B2
8308796 Lashinski et al. Nov 2012 B2
8323334 Deem et al. Dec 2012 B2
8353955 Styrc et al. Jan 2013 B2
RE44075 Williamson et al. Mar 2013 E
8449599 Chau et al. May 2013 B2
8454656 Tuval Jun 2013 B2
8470028 Thornton et al. Jun 2013 B2
8480730 Maurer et al. Jul 2013 B2
8486138 Vesely Jul 2013 B2
8506623 Wilson et al. Aug 2013 B2
8506624 Vidlund et al. Aug 2013 B2
8578705 Sindano et al. Nov 2013 B2
8579913 Nielsen Nov 2013 B2
8591573 Barone Nov 2013 B2
8591576 Hasenkam et al. Nov 2013 B2
8597347 Maurer et al. Dec 2013 B2
8685086 Navia et al. Apr 2014 B2
8790394 Miller et al. Jul 2014 B2
8845717 Khairkhahan et al. Sep 2014 B2
8888843 Khairkhahan et al. Nov 2014 B2
8900214 Nance et al. Dec 2014 B2
8900295 Migliazza et al. Dec 2014 B2
8926696 Cabiri et al. Jan 2015 B2
8932342 McHugo et al. Jan 2015 B2
8932348 Solem et al. Jan 2015 B2
8945208 Jimenez et al. Feb 2015 B2
8956407 Macoviak et al. Feb 2015 B2
8979922 Thambar et al. Mar 2015 B2
8986376 Solem Mar 2015 B2
9011522 Annest et al. Apr 2015 B2
9023099 Duffy et al. May 2015 B2
9034032 McLean et al. May 2015 B2
9034033 McLean et al. May 2015 B2
9039757 McLean et al. May 2015 B2
9039759 Alkhatib et al. May 2015 B2
9078645 Conklin et al. Jul 2015 B2
9078749 Lutter et al. Jul 2015 B2
9084676 Chau et al. Jul 2015 B2
9095433 Lutter et al. Aug 2015 B2
9125742 Yoganathan et al. Sep 2015 B2
9149357 Sequin Oct 2015 B2
9161837 Kapadia Oct 2015 B2
9168137 Subramanian et al. Oct 2015 B2
9232995 Kovalsky et al. Jan 2016 B2
9232998 Wilson et al. Jan 2016 B2
9232999 Maurer et al. Jan 2016 B2
9241702 Maisano et al. Jan 2016 B2
9254192 Lutter et al. Feb 2016 B2
9265608 Miller et al. Feb 2016 B2
9289295 Aklog et al. Mar 2016 B2
9289297 Wilson et al. Mar 2016 B2
9345573 Nyuli et al. May 2016 B2
9480557 Pellegrini et al. Nov 2016 B2
9480559 Vidlund et al. Nov 2016 B2
9526611 Tegels et al. Dec 2016 B2
9597181 Christianson et al. Mar 2017 B2
9610159 Christianson et al. Apr 2017 B2
9675454 Vidlund et al. Jun 2017 B2
9730792 Lutter et al. Aug 2017 B2
9827092 Vidlund et al. Nov 2017 B2
9833315 Vidlund et al. Dec 2017 B2
9867700 Bakis et al. Jan 2018 B2
9895221 Vidlund Feb 2018 B2
20010018611 Solem et al. Aug 2001 A1
20010021872 Bailey et al. Sep 2001 A1
20010025171 Mortier et al. Sep 2001 A1
20020010427 Scarfone et al. Jan 2002 A1
20020116054 Lundell et al. Aug 2002 A1
20020139056 Finnell Oct 2002 A1
20020151961 Lashinski et al. Oct 2002 A1
20020161377 Rabkin Oct 2002 A1
20020173842 Buchanan Nov 2002 A1
20020183827 Derus et al. Dec 2002 A1
20030010509 Hoffman Jan 2003 A1
20030036698 Kohler et al. Feb 2003 A1
20030050694 Yang et al. Mar 2003 A1
20030078652 Sutherland Apr 2003 A1
20030100939 Yodfat et al. May 2003 A1
20030105519 Fasol et al. Jun 2003 A1
20030105520 Alferness et al. Jun 2003 A1
20030120340 Liska et al. Jun 2003 A1
20030130731 Vidlund et al. Jul 2003 A1
20030149476 Damm et al. Aug 2003 A1
20030212454 Scott et al. Nov 2003 A1
20030233022 Vidlund Dec 2003 A1
20040039436 Spenser et al. Feb 2004 A1
20040049266 Anduiza et al. Mar 2004 A1
20040064014 Melvin et al. Apr 2004 A1
20040092858 Wilson et al. May 2004 A1
20040093075 Kuehne May 2004 A1
20040097865 Anderson et al. May 2004 A1
20040127983 Mortier et al. Jul 2004 A1
20040133263 Dusbabek et al. Jul 2004 A1
20040147958 Lam et al. Jul 2004 A1
20040152947 Schroeder et al. Aug 2004 A1
20040162610 Liska et al. Aug 2004 A1
20040163828 Silverstein et al. Aug 2004 A1
20040181239 Dorn et al. Sep 2004 A1
20040186565 Schreck Sep 2004 A1
20040186566 Hindrichs et al. Sep 2004 A1
20040260317 Bloom et al. Dec 2004 A1
20040260389 Case et al. Dec 2004 A1
20050004652 Van der Burg et al. Jan 2005 A1
20050004666 Alfieri et al. Jan 2005 A1
20050075727 Wheatley Apr 2005 A1
20050080402 Santamore et al. Apr 2005 A1
20050085900 Case et al. Apr 2005 A1
20050096498 Houser et al. May 2005 A1
20050107661 Lau et al. May 2005 A1
20050113798 Slater et al. May 2005 A1
20050113810 Houser et al. May 2005 A1
20050113811 Houser et al. May 2005 A1
20050119519 Girard et al. Jun 2005 A9
20050121206 Dolan Jun 2005 A1
20050125012 Houser et al. Jun 2005 A1
20050137686 Salahieh et al. Jun 2005 A1
20050137688 Salahieh et al. Jun 2005 A1
20050137695 Salahieh et al. Jun 2005 A1
20050137698 Salahieh et al. Jun 2005 A1
20050148815 Mortier et al. Jul 2005 A1
20050177180 Kaganov et al. Aug 2005 A1
20050197695 Stacchino Sep 2005 A1
20050203614 Forster et al. Sep 2005 A1
20050203615 Forster et al. Sep 2005 A1
20050203617 Forster et al. Sep 2005 A1
20050234546 Nugent et al. Oct 2005 A1
20050240200 Bergheim Oct 2005 A1
20050251209 Saadat et al. Nov 2005 A1
20050256567 Lim et al. Nov 2005 A1
20050283231 Haug et al. Dec 2005 A1
20050288766 Plain et al. Dec 2005 A1
20060004442 Spenser et al. Jan 2006 A1
20060025784 Starksen et al. Feb 2006 A1
20060025857 Bergheim et al. Feb 2006 A1
20060030885 Hyde Feb 2006 A1
20060042803 Gallaher Mar 2006 A1
20060047338 Jenson et al. Mar 2006 A1
20060052868 Mortier et al. Mar 2006 A1
20060058872 Salahieh et al. Mar 2006 A1
20060094983 Burbank et al. May 2006 A1
20060129025 Levine et al. Jun 2006 A1
20060142784 Kontos Jun 2006 A1
20060161040 McCarthy et al. Jul 2006 A1
20060161249 Realyvasquez et al. Jul 2006 A1
20060167541 Lattouf Jul 2006 A1
20060195134 Crittenden Aug 2006 A1
20060195183 Navia et al. Aug 2006 A1
20060229708 Powell et al. Oct 2006 A1
20060229719 Marquez et al. Oct 2006 A1
20060241745 Solem Oct 2006 A1
20060247491 Vidlund et al. Nov 2006 A1
20060259135 Navia et al. Nov 2006 A1
20060259136 Nguyen et al. Nov 2006 A1
20060259137 Artof et al. Nov 2006 A1
20060276874 Wilson et al. Dec 2006 A1
20060282161 Huynh et al. Dec 2006 A1
20060287716 Banbury et al. Dec 2006 A1
20060287717 Rowe et al. Dec 2006 A1
20070005131 Taylor Jan 2007 A1
20070005231 Seguchi Jan 2007 A1
20070010877 Salahieh et al. Jan 2007 A1
20070016286 Herrmann et al. Jan 2007 A1
20070016288 Gurskis et al. Jan 2007 A1
20070027535 Purdy et al. Feb 2007 A1
20070038291 Case et al. Feb 2007 A1
20070050020 Spence Mar 2007 A1
20070061010 Hauser et al. Mar 2007 A1
20070066863 Rafiee et al. Mar 2007 A1
20070073387 Forster et al. Mar 2007 A1
20070078297 Rafiee et al. Apr 2007 A1
20070083076 Lichtenstein Apr 2007 A1
20070083259 Bloom et al. Apr 2007 A1
20070093890 Eliasen et al. Apr 2007 A1
20070100439 Cangialosi et al. May 2007 A1
20070112422 Dehdashtian May 2007 A1
20070112425 Schaller et al. May 2007 A1
20070118151 Davidson May 2007 A1
20070118154 Crabtree May 2007 A1
20070118210 Pinchuk May 2007 A1
20070118213 Loulmet May 2007 A1
20070142906 Figulla et al. Jun 2007 A1
20070161846 Nikolic et al. Jul 2007 A1
20070162048 Quinn et al. Jul 2007 A1
20070162103 Case et al. Jul 2007 A1
20070168024 Khairkhahan Jul 2007 A1
20070185565 Schwammenthal et al. Aug 2007 A1
20070185571 Kapadia et al. Aug 2007 A1
20070203575 Forster et al. Aug 2007 A1
20070213813 Von Segesser et al. Sep 2007 A1
20070215362 Rodgers Sep 2007 A1
20070221388 Johnson Sep 2007 A1
20070233239 Navia et al. Oct 2007 A1
20070239265 Birdsall Oct 2007 A1
20070256843 Pahila Nov 2007 A1
20070265609 Thapliyal Nov 2007 A1
20070265658 Nelson et al. Nov 2007 A1
20070267202 Mariller Nov 2007 A1
20070270932 Headley et al. Nov 2007 A1
20070270943 Solem Nov 2007 A1
20070293944 Spenser et al. Dec 2007 A1
20080009940 Cribier Jan 2008 A1
20080033543 Gurskis et al. Feb 2008 A1
20080065011 Marchand et al. Mar 2008 A1
20080071361 Tuval et al. Mar 2008 A1
20080071362 Tuval et al. Mar 2008 A1
20080071363 Tuval et al. Mar 2008 A1
20080071366 Tuval et al. Mar 2008 A1
20080071368 Tuval et al. Mar 2008 A1
20080071369 Tuval et al. Mar 2008 A1
20080082163 Woo Apr 2008 A1
20080082166 Styrc et al. Apr 2008 A1
20080091264 Machold et al. Apr 2008 A1
20080114442 Mitchell et al. May 2008 A1
20080125861 Webler et al. May 2008 A1
20080147179 Cai et al. Jun 2008 A1
20080154355 Benichou et al. Jun 2008 A1
20080154356 Obermiller et al. Jun 2008 A1
20080161911 Revuelta et al. Jul 2008 A1
20080172035 Starksen et al. Jul 2008 A1
20080177381 Navia et al. Jul 2008 A1
20080183203 Fitzgerald et al. Jul 2008 A1
20080183273 Mesana et al. Jul 2008 A1
20080188928 Salahieh et al. Aug 2008 A1
20080208328 Antocci et al. Aug 2008 A1
20080208332 Lamphere et al. Aug 2008 A1
20080221672 Lamphere et al. Sep 2008 A1
20080243150 Starksen et al. Oct 2008 A1
20080243245 Thambar et al. Oct 2008 A1
20080255660 Guyenot et al. Oct 2008 A1
20080255661 Straubinger et al. Oct 2008 A1
20080281411 Berreklouw Nov 2008 A1
20080288060 Kaye et al. Nov 2008 A1
20080293996 Evans et al. Nov 2008 A1
20090005863 Goetz et al. Jan 2009 A1
20090048668 Wilson et al. Feb 2009 A1
20090054968 Bonhoeffer et al. Feb 2009 A1
20090054974 McGuckin, Jr. et al. Feb 2009 A1
20090062908 Bonhoeffer et al. Mar 2009 A1
20090076598 Salahieh et al. Mar 2009 A1
20090082619 De Marchena Mar 2009 A1
20090088836 Bishop et al. Apr 2009 A1
20090099410 De Marchena Apr 2009 A1
20090112309 Jaramillo Apr 2009 A1
20090131849 Maurer et al. May 2009 A1
20090132035 Roth et al. May 2009 A1
20090137861 Goldberg et al. May 2009 A1
20090138079 Tuval et al. May 2009 A1
20090157175 Benichou Jun 2009 A1
20090164005 Dove et al. Jun 2009 A1
20090171432 Von Segesser et al. Jul 2009 A1
20090171447 Von Segesser et al. Jul 2009 A1
20090171456 Kveen et al. Jul 2009 A1
20090177266 Powell et al. Jul 2009 A1
20090192601 Rafiee et al. Jul 2009 A1
20090210052 Forster et al. Aug 2009 A1
20090216322 Le et al. Aug 2009 A1
20090222076 Figulla et al. Sep 2009 A1
20090224529 Gill Sep 2009 A1
20090234318 Loulmet et al. Sep 2009 A1
20090234435 Johnson et al. Sep 2009 A1
20090234443 Ottma et al. Sep 2009 A1
20090240320 Tuval et al. Sep 2009 A1
20090248149 Gabbay Oct 2009 A1
20090276040 Rowe et al. Nov 2009 A1
20090281619 Le et al. Nov 2009 A1
20090287299 Tabor et al. Nov 2009 A1
20090292262 Adams et al. Nov 2009 A1
20090319037 Rowe et al. Dec 2009 A1
20090326575 Galdonik et al. Dec 2009 A1
20100016958 St. Goar et al. Jan 2010 A1
20100021382 Dorshow et al. Jan 2010 A1
20100023117 Yoganathan et al. Jan 2010 A1
20100036479 Hill et al. Feb 2010 A1
20100049313 Alon et al. Feb 2010 A1
20100082094 Quadri et al. Apr 2010 A1
20100126275 Leyh May 2010 A1
20100161041 Maisano et al. Jun 2010 A1
20100168839 Braido et al. Jul 2010 A1
20100179641 Ryan et al. Jul 2010 A1
20100185277 Braido et al. Jul 2010 A1
20100185278 Schankereli Jul 2010 A1
20100191326 Alkhatib Jul 2010 A1
20100192402 Yamaguchi et al. Aug 2010 A1
20100204781 Alkhatib Aug 2010 A1
20100210899 Schankereli Aug 2010 A1
20100217382 Chau et al. Aug 2010 A1
20100249489 Jarvik Sep 2010 A1
20100249923 Alkhatib et al. Sep 2010 A1
20100280604 Zipory et al. Nov 2010 A1
20100286768 Alkhatib Nov 2010 A1
20100298755 McNamara et al. Nov 2010 A1
20100298931 Quadri et al. Nov 2010 A1
20110004296 Lutter et al. Jan 2011 A1
20110015616 Straubinger et al. Jan 2011 A1
20110015728 Jimenez et al. Jan 2011 A1
20110015729 Jimenez et al. Jan 2011 A1
20110029072 Gabbay Feb 2011 A1
20110066231 Cartledge et al. Mar 2011 A1
20110066233 Thornton et al. Mar 2011 A1
20110098572 Chen Apr 2011 A1
20110112632 Chau et al. May 2011 A1
20110137397 Chau et al. Jun 2011 A1
20110137408 Bergheim Jun 2011 A1
20110224655 Asirvatham et al. Sep 2011 A1
20110224678 Gabbay Sep 2011 A1
20110224728 Martin et al. Sep 2011 A1
20110224784 Quinn Sep 2011 A1
20110245911 Quill et al. Oct 2011 A1
20110251682 Murray, III et al. Oct 2011 A1
20110264191 Rothstein Oct 2011 A1
20110264206 Tabor Oct 2011 A1
20110288637 De Marchena Nov 2011 A1
20110319988 Schankereli et al. Dec 2011 A1
20110319989 Lane et al. Dec 2011 A1
20120010694 Lutter et al. Jan 2012 A1
20120016468 Robin et al. Jan 2012 A1
20120022640 Gross et al. Jan 2012 A1
20120035703 Lutter et al. Feb 2012 A1
20120035713 Lutter et al. Feb 2012 A1
20120035722 Tuval Feb 2012 A1
20120053686 McNamara et al. Mar 2012 A1
20120059487 Cunanan et al. Mar 2012 A1
20120089171 Hastings et al. Apr 2012 A1
20120101571 Thambar et al. Apr 2012 A1
20120101572 Kovalsky et al. Apr 2012 A1
20120116351 Chomas et al. May 2012 A1
20120123529 Levi et al. May 2012 A1
20120130391 Sundt, III May 2012 A1
20120165930 Gifford et al. Jun 2012 A1
20120179244 Schankereli et al. Jul 2012 A1
20120203336 Annest Aug 2012 A1
20120215303 Quadri et al. Aug 2012 A1
20120226348 Lane et al. Sep 2012 A1
20120283824 Lutter et al. Nov 2012 A1
20120289945 Segermark Nov 2012 A1
20130030522 Rowe et al. Jan 2013 A1
20130053950 Rowe et al. Feb 2013 A1
20130066341 Ketai et al. Mar 2013 A1
20130079873 Migliazza et al. Mar 2013 A1
20130131788 Quadri et al. May 2013 A1
20130172978 Vidlund et al. Jul 2013 A1
20130184811 Rowe et al. Jul 2013 A1
20130190860 Sundt, III Jul 2013 A1
20130190861 Chau et al. Jul 2013 A1
20130197622 Mitra et al. Aug 2013 A1
20130226288 Goldwasser et al. Aug 2013 A1
20130231735 Deem et al. Sep 2013 A1
20130274874 Hammer Oct 2013 A1
20130282101 Eidenschink et al. Oct 2013 A1
20130310928 Morriss et al. Nov 2013 A1
20130317603 McLean et al. Nov 2013 A1
20130325041 Annest et al. Dec 2013 A1
20130325110 Khalil et al. Dec 2013 A1
20130338752 Geusen et al. Dec 2013 A1
20140046433 Kovalsky Feb 2014 A1
20140081323 Hawkins Mar 2014 A1
20140094918 Vishnubholta et al. Apr 2014 A1
20140142691 Pouletty May 2014 A1
20140163668 Rafiee Jun 2014 A1
20140194981 Menk et al. Jul 2014 A1
20140194983 Kovalsky et al. Jul 2014 A1
20140214159 Vidlund et al. Jul 2014 A1
20140222142 Kovalsky et al. Aug 2014 A1
20140243966 Garde et al. Aug 2014 A1
20140277419 Garde et al. Sep 2014 A1
20140296969 Tegels et al. Oct 2014 A1
20140296970 Ekvall et al. Oct 2014 A1
20140296971 Tegels et al. Oct 2014 A1
20140296972 Tegels et al. Oct 2014 A1
20140296975 Tegels et al. Oct 2014 A1
20140303718 Tegels et al. Oct 2014 A1
20140309732 Solem Oct 2014 A1
20140316516 Vidlund et al. Oct 2014 A1
20140324160 Benichou et al. Oct 2014 A1
20140324161 Tegels et al. Oct 2014 A1
20140324164 Gross et al. Oct 2014 A1
20140331475 Duffy et al. Nov 2014 A1
20140358224 Tegels et al. Dec 2014 A1
20140364942 Straubinger et al. Dec 2014 A1
20140364944 Lutter et al. Dec 2014 A1
20140379076 Vidlund et al. Dec 2014 A1
20150005874 Vidlund et al. Jan 2015 A1
20150011821 Gorman et al. Jan 2015 A1
20150025553 Del Nido et al. Jan 2015 A1
20150057705 Vidlund et al. Feb 2015 A1
20150073542 Heldman Mar 2015 A1
20150073545 Braido Mar 2015 A1
20150094802 Buchbinder et al. Apr 2015 A1
20150105856 Rowe et al. Apr 2015 A1
20150119936 Gilmore et al. Apr 2015 A1
20150119978 Tegels et al. Apr 2015 A1
20150127093 Hosmer et al. May 2015 A1
20150127096 Rowe et al. May 2015 A1
20150134050 Solem et al. May 2015 A1
20150142100 Morriss et al. May 2015 A1
20150142101 Coleman et al. May 2015 A1
20150142103 Vidlund May 2015 A1
20150142104 Braido May 2015 A1
20150173897 Raanani et al. Jun 2015 A1
20150196393 Vidlund et al. Jul 2015 A1
20150196688 James et al. Jul 2015 A1
20150202044 Chau et al. Jul 2015 A1
20150216653 Freudenthanl Aug 2015 A1
20150216660 Pintor et al. Aug 2015 A1
20150223820 Olson et al. Aug 2015 A1
20150223934 Vidlund et al. Aug 2015 A1
20150238312 Lashinski Aug 2015 A1
20150238729 Jenson et al. Aug 2015 A1
20150272731 Racchini et al. Oct 2015 A1
20150305860 Wang et al. Oct 2015 A1
20150305864 Quadri et al. Oct 2015 A1
20150305868 Lutter et al. Oct 2015 A1
20150327995 Morin et al. Nov 2015 A1
20150328001 McLean et al. Nov 2015 A1
20150335424 McLean et al. Nov 2015 A1
20150335429 Morriss et al. Nov 2015 A1
20150342717 O'Donnell et al. Dec 2015 A1
20150351903 Morriss et al. Dec 2015 A1
20150351906 Hammer et al. Dec 2015 A1
20160000562 Siegel Jan 2016 A1
20160008131 Christianson et al. Jan 2016 A1
20160067042 Murad et al. Mar 2016 A1
20160074160 Christianson et al. Mar 2016 A1
20160106537 Christianson et al. Apr 2016 A1
20160113764 Sheahan et al. Apr 2016 A1
20160143736 Vidlund et al. May 2016 A1
20160151155 Lutter et al. Jun 2016 A1
20160242902 Morriss et al. Aug 2016 A1
20160262879 Meiri et al. Sep 2016 A1
20160262881 Schankereli et al. Sep 2016 A1
20160278955 Liu et al. Sep 2016 A1
20160317290 Chau et al. Nov 2016 A1
20160324635 Vidlund et al. Nov 2016 A1
20160331527 Vidlund et al. Nov 2016 A1
20160346086 Solem Dec 2016 A1
20160367365 Conklin Dec 2016 A1
20160367367 Maisano et al. Dec 2016 A1
20160367368 Vidlund et al. Dec 2016 A1
20170079790 Vidlund et al. Mar 2017 A1
20170100248 Tegels et al. Apr 2017 A1
20170128208 Christianson et al. May 2017 A1
20170181854 Christianson et al. Jun 2017 A1
20170196688 Christianson et al. Jul 2017 A1
20170252153 Chau et al. Sep 2017 A1
20170266001 Vidlund et al. Sep 2017 A1
20170281343 Christianson et al. Oct 2017 A1
20170312076 Lutter et al. Nov 2017 A1
20170312077 Vidlund et al. Nov 2017 A1
20170319333 Tegels et al. Nov 2017 A1
20180028314 Ekvall et al. Feb 2018 A1
20180078368 Vidlund et al. Mar 2018 A1
20180078370 Kovalsky et al. Mar 2018 A1
Foreign Referenced Citations (126)
Number Date Country
1486161 Mar 2004 CN
1961845 May 2007 CN
2902226 May 2007 CN
101146484 Mar 2008 CN
101180010 May 2008 CN
101984938 Mar 2011 CN
102869317 Jan 2013 CN
102869318 Jan 2013 CN
102869321 Jan 2013 CN
103220993 Jul 2013 CN
102639179 Oct 2014 CN
2246526 Mar 1973 DE
19532846 Mar 1997 DE
19546692 Jun 1997 DE
19857887 Jul 2000 DE
19907646 Aug 2000 DE
10049812 Apr 2002 DE
10049813 Apr 2002 DE
10049815 Apr 2002 DE
102006052564 Dec 2007 DE
102006052710 May 2008 DE
102007043830 Apr 2009 DE
102007043831 Apr 2009 DE
0103546 May 1988 EP
1057460 Dec 2000 EP
1088529 Apr 2001 EP
1469797 Nov 2005 EP
2111800 Oct 2009 EP
2193762 Jun 2010 EP
2747707 Apr 2015 EP
2918248 Sep 2015 EP
2278944 Mar 2016 EP
2788217 Jul 2000 FR
2815844 May 2002 FR
2003-505146 Feb 2003 JP
2005-515836 Jun 2005 JP
2009-514628 Apr 2009 JP
2013-512765 Apr 2013 JP
1017275 Aug 2002 NL
1271508 Nov 1986 SU
WO 9217118 Oct 1992 WO
WO 9301768 Feb 1993 WO
WO 9829057 Jul 1998 WO
WO 9940964 Aug 1999 WO
WO 9947075 Sep 1999 WO
WO 2000018333 Apr 2000 WO
WO 2000030550 Jun 2000 WO
WO 2000041652 Jul 2000 WO
WO 2000047139 Aug 2000 WO
WO 2001035878 May 2001 WO
WO 2001049213 Jul 2001 WO
WO 2001054624 Aug 2001 WO
WO 2001054625 Aug 2001 WO
WO 2001056512 Aug 2001 WO
WO 2001061289 Aug 2001 WO
WO 2001076510 Oct 2001 WO
WO 2001082840 Nov 2001 WO
WO 2002004757 Jan 2002 WO
WO 2002022054 Mar 2002 WO
WO 2002028321 Apr 2002 WO
WO 2002036048 May 2002 WO
WO 2002041789 May 2002 WO
WO 2002043620 Jun 2002 WO
WO 2002049540 Jun 2002 WO
WO 2002076348 Oct 2002 WO
WO 2003003943 Jan 2003 WO
WO 2003030776 Apr 2003 WO
WO 2003047468 Jun 2003 WO
WO 2003049619 Jun 2003 WO
WO 2004019825 Mar 2004 WO
WO 2005102181 Nov 2005 WO
WO 2006014233 Feb 2006 WO
WO 2006034008 Mar 2006 WO
WO 2006064490 Jun 2006 WO
WO 2006070372 Jul 2006 WO
WO 2006113906 Oct 2006 WO
WO 2006127756 Nov 2006 WO
WO 2007081412 Jul 2007 WO
WO 2008005405 Jan 2008 WO
WO 2008035337 Mar 2008 WO
WO 2008091515 Jul 2008 WO
WO 2008125906 Oct 2008 WO
WO 2008147964 Dec 2008 WO
WO 2009024859 Feb 2009 WO
WO 2009026563 Feb 2009 WO
WO 2009045338 Apr 2009 WO
WO 2009132187 Oct 2009 WO
WO 2010090878 Aug 2010 WO
WO 2010098857 Sep 2010 WO
WO 2010121076 Oct 2010 WO
WO 2011017440 Feb 2011 WO
WO 2011022658 Feb 2011 WO
WO 2011069048 Jun 2011 WO
WO 2011072084 Jun 2011 WO
WO 2011106735 Sep 2011 WO
WO 2011109813 Sep 2011 WO
WO 2011159342 Dec 2011 WO
WO 2011163275 Dec 2011 WO
WO 2012027487 Mar 2012 WO
WO 2012036742 Mar 2012 WO
WO 2012095116 Jul 2012 WO
WO 2012177942 Dec 2012 WO
WO 2013045262 Apr 2013 WO
WO 2013059747 Apr 2013 WO
WO 2013096411 Jun 2013 WO
WO 2013175468 Nov 2013 WO
WO 2014121280 Aug 2014 WO
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Non-Patent Literature Citations (50)
Entry
US 9,155,620 B2, 10/2015, Gross et al. (withdrawn)
International Search Report and Written Opinion for International Application No. PCT/US2014/061046, dated Feb. 24, 2015, 13 pages.
Al Zaibag, M. et al., “Percutaneous Balloon Valvotomy in Tricuspid Stenosis,” British Heart Journal, Jan. 1987, 57(1):51-53.
Al-Khaja, N. et al., “Eleven Years' Experience with Carpentier-Edwards Biological Valves in Relation to Survival and Complications,” European Journal of Cardiothoracic Surgery, Jun. 30, 1989, 3:305-311.
Almagor, Y. et al., “Balloon Expandable Stent Implantation in Stenotic Right Heart Valved Conduits,” Journal of the American College of Cardiology, Nov. 1, 1990, 16(6):1310-1314.
Andersen, H. R. et al., “Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs,” European Heart Journal, 1992, 13(5):704-708.
Andersen, H. R., “History of Percutaneous Aortic Valve Prosthesis,” Herz, Aug. 2009, 34(5):343-346.
Andersen, H. R., “Transluminal catheter implanted prosthetic heart valves,” International Journal of Angiology, 1998, 7(2):102-106.
Ashton, R. C., Jr. et al., “Development of an Intraluminal Device for the Treatment of Aortic Regurgitation: Prototype and in Vitro Testing System,” Journal of Thoracic and Cardiovascular Surgery, 1996, 112:979-983.
Benchimol, A. et al., “Simultaneous Left Ventricular Echocardiography and Aortic Blood Velocity During Rapid Right Ventricular Pacing in Man,” The American Journal of the Medical Sciences, Jan.-Feb. 1977, 273(1):55-62.
Bernacca, G. M. et al., “Polyurethane heart valves: Fatigue failure, calcification, and polyurethane structure,” Journal of Biomedical Materials Research, Mar. 5, 1997, 34(3):371-379.
Boudjemline, Y. et al., “Steps Toward the Percutaneous Replacement of Atrioventricular Valves: An Experimental Study,” Journal of the American College of Cardiology, Jul. 2005, 46(2):360-365.
Buckberg, G. et al., “Restoring Papillary Muscle Dimensions During Restoration in Dilated Hearts,” Interactive CardioVascular and Thoracic Surgery, 2005, 4:475-477.
Chamberlain, G., “Ceramics Replace Body Parts,” Design News, Jun. 9, 1997, Issue 11, vol. 52, 5 pages.
Choo, S. J. et al., “Aortic Root Geometry: Pattern of Differences Between Leaflets and Sinuses of Valsava,” The Journal of Heart Valve Disease, Jul. 1999, 8:407-415.
Declaration of Malcolm J. R. Dalrymple-Hay, Nov. 9, 2012, pp. 1-11; with Curriculum Vitae, Oct. 4, 2012.
Dotter, C. T. et al., “Transluminal Treatment of Arteriosclerotic Obstruction. Description of a New Technic and a Preliminary Report of its Application,” Circulation, Nov. 1964, 30:654-670.
Drawbaugh, K., “Feature—Heart Surgeons Explore Minimally Invasive Methods,” Reuters Limited, Jul. 16, 1996, 3 pages.
Gray, H., The Aorta, Anatomy of the Human Body, 1918, Retrieved from the Internet <http://www.bartleby.com/107/142.html>, Dec. 10, 2012, 5 pages.
Gray, H., The Heart, Anatomy of the Human Body, 1918, Retrieved from the Internet <http://education.yahoo.com/reference/gray/subjects/subject/138>, Aug. 10, 2012, 9 pages.
Greenhalgh, E. S., “Design and characterization of a biomimetic prosthetic aortic heart valve,” 1994, ProQuest Dissertations and Theses, Department of Fiber and Polymer Science, North Carolina State University at Raleigh, 159 pages.
Inoue, K. et al., “Clinical Application of Transvenous Mitral Commissurotomy by a New Balloon Catheter,” The Journal of Thoracic and Cardiovascular Surgery, 1984, 87:394-402.
Jin, X. Y. et al., “Aortic Root Geometry and Stentless Porcine Valve Competence,” Seminars in Thoracic and Cardiovascular Surgery, Oct. 1999, 11(4):145-150.
Knudsen, L. L. et al., “Catheter-implanted prosthetic heart valves. Transluminal catheter implantation of a new expandable artificial heart valve in the descending thoracic aorta in isolated vessels and closed chest pigs,” The International Journal of Artificial Organs, 1993, 16(5):253-262.
Kolata, G., “Device That Opens Clogged Arteries Gets a Failing Grade in a New Study,” New York Times [online], <http://www.nytimes.com/1991/01/03/health/device-that-opens-clogged-arteries-gets-a-faili . . . ,>, published Jan. 3, 1991, retrieved from the Internet on Feb. 5, 2016, 3 pages.
Lawrence, D. D., “Percutaneous Endovascular Graft: Experimental Evaluation,” Radiology, 1987, 163:357-360.
Lozonschi, L., et al. “Transapical mitral valved stent implantation: A survival series in swine,” The Journal of Thoracic and Cardiovascular Surgery, 140(2):422-426 (Aug. 2010) published online Mar. 12, 2010, 1 page.
Lutter, G. et al., “Mitral Valved Stent Implantation,” European Journal of Cardio-Thoracic Surgery, 2010, 38:350-355, 2 pages.
Ma, L. et al., “Double-crowned valved stents for off-pump mitral valve replacement,” European Journal of Cardio-Thoracic Surgery, Aug. 2005, 28(2):194-198.
Moazami, N. et al., “Transluminal aortic valve placement: A feasibility study with a newly designed collapsible aortic valve,” ASAIO Journal, Sep./ Oct. 1996, 42(5):M381-M385.
Orton, C., “Mitralseal: Hybrid Transcatheter Mitral Valve Replacement,” Retrieved from the Internet: <http:/www.acvs.org/symposium/proceedings2011/data/papers/102.pdf>, pp. 311-312.
Pavcnik, D. et al. “Development and Initial Experimental Evaluation of a Prosthetic Aortic Valve for Transcatheter Placement,” Radiology, 1992; 183:151-154.
Porstmann, W. et al., “Der Verschluβ des Ductus Arteriosus Persistens ohne Thorakotomie,” Thoraxchirurgie Vaskuläre Chirurgie, Band 15, Heft 2, Stuttgart, Apr. 1967, pp. 199-203.
Rashkind, W. J., “Creation of an Atrial Septal Defect Without Thoracotomy,” The Journal of the American Medical Association, Jun. 13, 1966, 196(11):173-174.
Rashkind, W. J., “Historical Aspects of Interventional Cardiology: Past, Present, Future,” Texas Heart Institute Journal, Dec. 1986, 13(4):363-367.
Reul, H. et al., “The Geometry of the Aortic Root in Health, at Valve Disease and After Valve Replacement,” J. Biomechanics, 1990, 23(2):181-191.
Rosch, J. et al., “The Birth, Early Years and Future of Interventional Radiology,” J Vasc Interv Radiol., Jul. 2003, 4:841-853.
Ross, D. N., “Aortic Valve Surgery,” Guy's Hospital, London, 1968, pp. 192-197.
Rousseau, E. P. M. et al., “A mechanical analysis of the closed Hancock heart valve prosthesis,” Journal of Biomechanics, 1988, 21(7):545-562.
Sabbah, A. N. et al., “Mechanical Factors in the Degeneration of Porcine Bioprosthetic Valves: An Overview,” Dec. 1989, Journal of Cardiac Surgery, 4(4):302-309.
Selby, J. B., “Experience with New Retrieval Forceps for Foreign Body Removal in the Vascular, Urinary, and Biliary Systems,” Radiology, 1990, 176:535-538.
Serruys, P. W. et al., “Stenting of Coronary Arteries. Are we the Sorcerer's Apprentice?,” European Heart Journal , Sep. 1989, 10(9):774-782.
“Shape Memory Alloys,” Retrieved from the Internet: <http://webdocs.cs.ualberta.ca/˜database/MEMS/sma.html>, Feb. 5, 2016, 3 pages.
Sigwart, U., “An Overview of Intravascular Stents: Old and New,” Chapter 48, Interventional Cardiology, 2nd Edition, W.B. Saunders Company, Philadelphia, PA, © 1994, 1990, pp. 803-815.
Tofeig, M. et al., “Transcatheter Closure of a Mid-Muscular Ventricular Septal Defect with an Amplatzer VSD Occluder Device,” Heart, 1999, 81:438-440.
Uchida, B. T. et al., “Modifications of Gianturco Expandable Wire Stents,” Am. J. Roentgenol., May 1988, 150(5):1185-1187.
Watt, A. H. et al., “Intravenous Adenosine in the Treatment of the Supraventricular Tachycardia; a Dose-Ranging Study and Interaction with Dipyridamole,” British Journal of Clinical Pharmacology, 1986, 21:227-230.
Webb, J. G. et al., “Percutaneous Aortic Valve Implantation Retrograde from the Femoral Artery,” Circulation, 2006, 113:842-850.
Wheatley, D. J., “Valve Prostheses,” Rob & Smith's Operative Surgery, Fourth Edition, 1986, pp. 415-424, Butterworths.
Yoganathan, A. P. et al., “The Current Status of Prosthetic Heart Valves,” In Polymetric Materials and Artificial Organs, American Chemical Society, 1984, pp. 111-150.
Related Publications (1)
Number Date Country
20160206280 A1 Jul 2016 US
Provisional Applications (1)
Number Date Country
61892390 Oct 2013 US
Continuations (1)
Number Date Country
Parent PCT/US2014/061046 Oct 2014 US
Child 15085229 US