A prosthetic delivery system may include a plurality of concentric shafts and an actuator mechanism for actuating one or more of the concentric shafts. A stop mechanism may be coupled to the actuator mechanism. The stop mechanism prevents advancement or retraction of at least some of the shafts beyond a predetermined position unless the stop mechanism is released. A second stop mechanism may be included in the system for controlling another of the shafts. A plurality of filaments may be coupled to a prosthesis carried by the delivery system and actuation of the filaments may be used to control deployment or retrieval of the prosthesis.
A low-profile prosthetic valve for treating a native valve includes a radially expandable frame having an expanded configuration and a collapsed configuration. The atrial end of the prosthetic valve forms a flared shape that engages an atrial surface of the native valve. The flare shape flares downward toward a ventricle of the native valve when initially expanded followed by inversion of the flared shape to form a tapered shape tapering toward the ventricle and flaring toward the atrium of the native valve when fully expanded. The prosthetic valve also has a plurality of prosthetic valve leaflets that open and close to control fluid flow through the prosthetic valve.
A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.
A method of delivering a prosthetic valve to a native mitral valve of patient's heart may include providing a radially expandable prosthetic mitral valve which has an upstream atrial portion, a downstream ventricular portion and an annular region therebetween. A constraint is removed from the ventricular portion thereby allowing radial expansion of a ventricular portion. A first anchoring tab on the ventricular portion is radially expanded and an annular region is radially expanded. An atrial skirt on the atrial flange is radially expanded after radial expansion of the ventricular portion.
A prosthetic valve may be used to repair a diseased or otherwise damaged heart valve such as the mitral valve. The prosthetic valve may include atraumatic anchor tabs which may be radiopaque or echogenic. A cinching mechanism may also be coupled to the prosthetic valve to control radial expansion of the prosthetic valve. The cinching mechanism may include a wire lasso or a belt. The prosthetic valve may include an expandable frame which has a reduced number of strut connection nodes to allow a lower profile collapsed configuration and tighter crimping. The commissure posts of the prosthetic valve may extend beyond an edge of the ventricular skirt portion of the device.
A prosthesis delivery catheter has an inner distal capsule shaft and a distal capsule configured to house the prosthesis. An anchor catheter with an anchor hub is slidably disposed over the inner distal capsule shaft. An elbow catheter is slidably disposed over the anchor catheter, and a peg plate assembly is adjacent the anchor hub. The peg plate assembly has a plurality of protruding pegs and a plate which form a closed configuration with the pegs abutting the plate, and an open configuration where a gap is between the pegs and plate allowing release of a tether.
A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.
A prosthesis delivery catheter has an inner distal capsule shaft and a distal capsule configured to house the prosthesis. An anchor catheter with an anchor hub is slidably disposed over the inner distal capsule shaft. An elbow catheter is slidably disposed over the anchor catheter, and a peg plate assembly is adjacent the anchor hub. The peg plate assembly has a plurality of protruding pegs and a plate which form a closed configuration with the pegs abutting the plate, and an open configuration where a gap is between the pegs and plate allowing release of a tether.
A prosthetic valve may be formed to direct flow out of the outflow orifice toward a posterior portion of a heart wall. The prosthetic valve includes an expandable frame which may be covered with a cover that is suturelessly attached to the frame. The prosthetic valve may also include an outflow orifice size which is controlled. Methods of using these devices are also disclosed.
Methods for the rapid retraction of trans-catheter heart valve delivery systems are provided. A rapid retraction trans-catheter heart valve delivery system comprises a catheter based delivery system. The delivery system has internal mechanisms that allow for the controlled deployment of a heart valve prosthesis, as well as mechanisms that allow for quickly closing the catheter once the heart valve prosthesis has been implanted. This rapid retraction ability allows for reduced procedural durations and thus reduced risk to the patient.
A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.
A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.
A low-profile prosthetic valve for treating a native valve includes a radially expandable frame having an expanded configuration and a collapsed configuration. The atrial end of the prosthetic valve forms a flared shape that engages an atrial surface of the native valve. The flare shape flares downward toward a ventricle of the native valve when initially expanded followed by inversion of the flared shape to form a tapered shape tapering toward the ventricle and flaring toward the atrium of the native valve when fully expanded. The prosthetic valve also has a plurality of prosthetic valve leaflets that open and close to control fluid flow through the prosthetic valve.
A device for loading a prosthesis onto a delivery system includes a first housing having a central bore, One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A low-profile prosthetic valve for treating a native valve includes a radially expandable frame having an expanded configuration and a collapsed configuration. The atrial end of the prosthetic valve forms a flared shape that engages an atrial surface of the native valve. The flare shape flares downward toward a ventricle of the native valve when initially expanded followed by inversion of the flared shape to form a tapered shape tapering toward the ventricle and flaring toward the atrium of the native valve when fully expanded. The prosthetic valve also has a plurality of prosthetic valve leaflets that open and close to control fluid flow through the prosthetic valve.
A low-profile prosthetic valve for treating a native valve includes a radially expandable frame having an expanded configuration and a collapsed configuration. The atrial end of the prosthetic valve forms a flared shape that engages an atrial surface of the native valve. The flare shape flares downward toward a ventricle of the native valve when initially expanded followed by inversion of the flared shape to form a tapered shape tapering toward the ventricle and flaring toward the atrium of the native valve when fully expanded. The prosthetic valve also has a plurality of prosthetic valve leaflets that open and close to control fluid flow through the prosthetic valve.
An introducer sheath includes an elongate shaft having a proximal end, a distal end and a lumen extending therebetween. An actuatable hemostasis valve in a hub is adjacent the proximal end of the elongate shaft and may be used to prevent blood from escaping from the elongate shaft. The introducer sheath may also have a a self-expanding funnel adjacent the distal end of the elongate shaft.
An introducer sheath includes an elongate shaft having a proximal end, a distal end and a lumen extending therebetween. An actuatable hemostasis valve in a hub is adjacent the proximal end of the elongate shaft and may be used to prevent blood from escaping from the elongate shaft. The introducer sheath may also have a a self-expanding funnel adjacent the distal end of the elongate shaft.
A prosthetic valve may be formed to direct flow out of the outflow orifice toward a posterior portion of a heart wall. The prosthetic valve includes an expandable frame which may be covered with a cover that is suturelessly attached to the frame. The prosthetic valve may also include an outflow orifice size which is controlled. Methods of using these devices are also disclosed.
A prosthetic valve may be formed to direct flow out of the outflow orifice toward a posterior portion of a heart wall. The prosthetic valve includes an expandable frame which may be covered with a cover that is suturelessly attached to the frame. The prosthetic valve may also include an outflow orifice size which is controlled. Methods of using these devices are also disclosed.
A prosthetic valve may be used to repair a diseased or otherwise damaged heart valve such as the mitral valve. The prosthetic valve may include atraumatic anchor tabs which may be radiopaque or echogenic. A cinching mechanism may also be coupled to the prosthetic valve to control radial expansion of the prosthetic valve. The cinching mechanism may include a wire lasso or a belt. The prosthetic valve may include an expandable frame which has a reduced number of strut connection nodes to allow a lower profile collapsed configuration and tighter crimping. The commissure posts of the prosthetic valve may extend beyond an edge of the ventricular skirt portion of the device.
A prosthetic valve may be used to repair a diseased or otherwise damaged heart valve such as the mitral valve. The prosthetic valve may include atraumatic anchor tabs which may be radiopaque or echogenic. A cinching mechanism may also be coupled to the prosthetic valve to control radial expansion of the prosthetic valve. The cinching mechanism may include a wire lasso or a belt. The prosthetic valve may include an expandable frame which has a reduced number of strut connection nodes to allow a lower profile collapsed configuration and tighter crimping. The commissure posts of the prosthetic valve may extend beyond an edge of the ventricular skirt portion of the device.
A prosthetic delivery system may include a plurality of concentric shafts and an actuator mechanism for actuating one or more of the concentric shafts. A stop mechanism may be coupled to the actuator mechanism. The stop mechanism prevents advancement or retraction of at least some of the shafts beyond a predetermined position unless the stop mechanism is released. A second stop mechanism may be included in the system for controlling another of the shafts. A plurality of filaments may be coupled to a prosthesis carried by the delivery system and actuation of the filaments may be used to control deployment or retrieval of the prosthesis.
A61F 2/954 - Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
A61F 2/966 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
A61F 2/97 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
A prosthetic delivery system may include a plurality of concentric shafts and an actuator mechanism for actuating one or more of the concentric shafts. A stop mechanism may be coupled to the actuator mechanism. The stop mechanism prevents advancement or retraction of at least some of the shafts beyond a predetermined position unless the stop mechanism is released. A second stop mechanism may be included in the system for controlling another of the shafts. A plurality of filaments may be coupled to a prosthesis carried by the delivery system and actuation of the filaments may be used to control deployment or retrieval of the prosthesis.
A prosthetic valve for implanting in a patient's native valve has a self-expanding frame that comprises a first end, a second end opposite the first end, an anterior portion, and a posterior portion. The self-expanding frame has an expanded configuration adapted to engage tissue at a treatment site, and a collapsed configuration adapted to be delivered to the treatment site. The expandable frame also comprises a self-expanding atrial skirt near the second end, a self-expanding ventricular skirt near the first end, a self-expanding annular region disposed between first and second ends, a first self-expanding anterior tab disposed on the anterior portion, and a self-expanding foot coupled to the posterior portion and extending radially outward. The foot has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.
A delivery system includes a delivery catheter with a capsule configured to carry a prosthesis and a steering catheter for steering the delivery catheter. The delivery catheter can be advanced through a patient's vasculature to a target treatment area. The capsule can be opened and the prosthesis can be deployed into the target treatment area. Additionally, a method for delivering a prosthesis to a target treatment area includes advancing a delivery catheter through a patient's vasculature to the target treatment area, steering the delivery catheter toward the target treatment area, opening a capsule on the delivery catheter, and deploying the prosthesis into the target treatment area.
Methods for the rapid retraction of trans-catheter heart valve delivery systems are provided. A rapid retraction trans-catheter heart valve delivery system comprises a catheter based delivery system. The delivery system has internal mechanisms that allow for the controlled deployment of a heart valve prosthesis, as well as mechanisms that allow for quickly closing the catheter once the heart valve prosthesis has been implanted. This rapid retraction ability allows for reduced procedural durations and thus reduced risk to the patient.
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.
A method of delivering a prosthetic valve to a native mitral valve of patient's heart may include providing a radially expandable prosthetic mitral valve which has an upstream atrial portion, a downstream ventricular portion and an annular region therebetween. A constraint is removed from the ventricular portion thereby allowing radial expansion of a ventricular portion. A first anchoring tab on the ventricular portion is radially expanded and an annular region is radially expanded. An atrial skirt on the atrial flange is radially expanded after radial expansion of the ventricular portion.
A method of delivering a prosthetic valve to a native mitral valve of patient's heart may include providing a radially expandable prosthetic mitral valve which has an upstream atrial portion, a downstream ventricular portion and an annular region therebetween. A constraint is removed from the ventricular portion thereby allowing radial expansion of a ventricular portion. A first anchoring tab on the ventricular portion is radially expanded and an annular region is radially expanded. An atrial skirt on the atrial flange is radially expanded after radial expansion of the ventricular portion.
A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.
A method for delivering a prosthetic valve to a patient's heart having a native valve with a plurality of valve leaflets includes providing a delivery device with a prosthetic valve, advancing the delivery device toward the native valve, and expanding a portion of the prosthetic valve to form a flanged region that is upstream of the valve leaflets. One or more tabs on the prosthetic valve are released so that they expand outward to a position that is transverse to the longitudinal axis of the prosthetic valve. The position of the prosthetic valve is adjusted relative to the valve leaflets and rapid pacing is applied to the patient's heart so that the valve leaflets move inward toward the prosthetic valve or the delivery device. The tabs are further released to allow the tabs to move into their final positions.
A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.
A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.
A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.
Methods for the rapid retraction of trans-catheter heart valve delivery systems are provided. A rapid retraction trans-catheter heart valve delivery system comprises a catheter based delivery system. The delivery system has internal mechanisms that allow for the controlled deployment of a heart valve prosthesis, as well as mechanisms that allow for quickly closing the catheter once the heart valve prosthesis has been implanted. This rapid retraction ability allows for reduced procedural durations and thus reduced risk to the patient.
A61M 25/088 - Introducing, guiding, advancing, emplacing or holding catheters using an additional catheter, e.g. to reach relatively inaccessible places
A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.
A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
A61M 25/04 - Holding devices, e.g. on the body in the body, e.g. expansible
48.
Prosthetic valve for avoiding obstruction of outflow
A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.
A method for delivering a prosthetic valve to a patient's heart having a native valve with a plurality of valve leaflets includes providing a delivery device with a prosthetic valve, advancing the delivery device toward the native valve, and expanding a portion of the prosthetic valve to form a flanged region that is upstream of the valve leaflets. One or more tabs on the prosthetic valve are released so that they expand outward to a position that is transverse to the longitudinal axis of the prosthetic valve. The position of the prosthetic valve is adjusted relative to the valve leaflets and rapid pacing is applied to the patient's heart so that the valve leaflets move inward toward the prosthetic valve or the delivery device. The tabs are further released to allow the tabs to move into their final positions.
A delivery system includes a delivery catheter with a capsule configured to carry a prosthesis and a steering catheter for steering the delivery catheter. The delivery catheter can be advanced through a patient's vasculature to a target treatment area. The capsule can be opened and the prosthesis can be deployed into the target treatment area. Additionally, a method for delivering a prosthesis to a target treatment area includes advancing a delivery catheter through a patient's vasculature to the target treatment area, steering the delivery catheter toward the target treatment area, opening a capsule on the delivery catheter, and deploying the prosthesis into the target treatment area.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A61F 2/95 - Instruments specially adapted for placement or removal of stents or stent-grafts
A61F 2/966 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
A delivery system includes a delivery catheter with a capsule configured to carry a prosthesis and a steering catheter for steering the delivery catheter. The delivery catheter can be advanced through a patient's vasculature to a target treatment area. The capsule can be opened and the prosthesis can be deployed into the target treatment area. Additionally, a method for delivering a prosthesis to a target treatment area includes advancing a delivery catheter through a patient's vasculature to the target treatment area, steering the delivery catheter toward the target treatment area, opening a capsule on the delivery catheter, and deploying the prosthesis into the target treatment area.
A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A method for delivering a prosthetic valve to a patient's heart having a native valve with a plurality of valve leaflets includes providing a delivery device with a prosthetic valve, advancing the delivery device toward the native valve, and expanding a portion of the prosthetic valve to form a flanged region that is upstream of the valve leaflets. One or more tabs on the prosthetic valve are released so that they expand outward to a position that is transverse to the longitudinal axis of the prosthetic valve. The position of the prosthetic valve is adjusted relative to the valve leaflets and rapid pacing is applied to the patient's heart so that the valve leaflets move inward toward the prosthetic valve or the delivery device. The tabs are further released to allow the tabs to move into their final positions.
A prosthetic valve for implanting in a patient's native valve has a self-expanding frame that comprises a first end, a second end opposite the first end, an anterior portion, and a posterior portion. The self-expanding frame has an expanded configuration adapted to engage tissue at a treatment site, and a collapsed configuration adapted to be delivered to the treatment site. The expandable frame also comprises a self-expanding atrial skirt near the second end, a self-expanding ventricular skirt near the first end, a self-expanding annular region disposed between first and second ends, a first self-expanding anterior tab disposed on the anterior portion, and a self-expanding foot coupled to the posterior portion and extending radially outward. The foot has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.
A prosthetic valve for implanting in a patient's native valve has a self-expanding frame that comprises a first end, a second end opposite the first end, an anterior portion, and a posterior portion. The self-expanding frame has an expanded configuration adapted to engage tissue at a treatment site, and a collapsed configuration adapted to be delivered to the treatment site. The expandable frame also comprises a self-expanding atrial skirt near the second end, a self-expanding ventricular skirt near the first end, a self-expanding annular region disposed between first and second ends, a first self-expanding anterior tab disposed on the anterior portion, and a self-expanding foot coupled to the posterior portion and extending radially outward. The foot has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.
A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.
A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.
A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.
A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.
A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.
A61F 2/966 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A sequentially deployed prosthetic cardiac valve which includes a self-expanding frame having a first end, a second end opposite the first end, an atrial region near the second end, and a ventricular region near the first end. The self-expanding frame has an expandedconfiguration and a collapsed configuration. The expanded configuration adapted to engage heart tissue, and the collapsed configuration adapted to be delivered to a patient's heart. The valve also includes a self-expanding atrial skirt disposed in the atrial region and a self-expanding ventricular skirt disposed in the ventricular region. The ventricular skirt includes struts with a length. The valve also includes a self-expanding annular region disposed between the atrial region and the ventricular region and a first self-expanding anterior tab disposed on an anterior portion of the self-expanding frame in the ventricular region. The anterior tab includes struts with a length. The valve also includes a self-expanding posterior tab on a posterior portion of the self-expanding frame in the ventricular region. The posterior tab includes struts with a length. The length of the struts in the anterior tab are shorter than the length of the struts in the ventricular skirt. The length of the struts in posterior tab are longer than the length of the struts in the anterior tab. A portion of the first self-expanding anterior tab and a portion of the self expanding posterior tab partially self-expand radially outward when a constraint is removed therefrom. The first anterior tab fully self-expands radially outward before the posterior tab fully self-expands radially outward when the constraint is removed therefrom. The posterior tab fully self-expands radially outward before ventricular skirt self expands when the constraint is removed therefrom, and wherein the ventricular skirt fully expands last.
A61F 2/966 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.
A method for loading a prosthesis onto a delivery system is provided which involves providing a prosthetic valve having a plurality of commissure posts coupled thereto. The prosthetic valve includes an unbiased diameter. The method also involves reducing the unbiased diameter of the prosthetic valve in selected discrete regions. The selected discrete regions include the commissure posts. The method also involves loading the reduced diameter prosthetic valve onto a delivery device
A method of delivering a prosthetic valve to a native mitral valve of patient's heart may include providing a radially expandable prosthetic mitral valve which Has an upstream atrial portion, a downstream ventricular portion and annular region therebetween. A constraint is removed from the ventricular portion thereby allowing radial expansion of a ventricular portion. A first anchoring tab on the ventricular portion is radially expanded and an annular region is radially expanded. An atrial skirt on the atrial flange is radially expanded after radial expansion of the ventricular portion.
A prosthetic valve for implanting in a patient's native valve has a self-expanding frame that comprises a first end, a second end opposite the first end, an anterior portion, and a posterior portion. The self-expanding frame has an expanded configuration adapted to engage tissue at a treatment site, and a collapsed configuration adapted to be delivered to the treatment site. The expandable frame also comprises a self-expanding atrial skirt near the second end, a self-expanding ventricular skirt near the first end, a self-expanding annular region disposed between first and second ends, a first self-expanding anterior tab disposed on the anterior portion, and a self-expanding foot coupled to the posterior portion and extending radially outward. The foot has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.
A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.
A61F 2/966 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
A delivery system includes a delivery catheter with a capsule configured to carry a prosthesis and a steering catheter for steering the delivery catheter. The delivery catheter can be advanced through a patient's vasculature to a target treatment area. The capsule can be opened and the prosthesis can be deployed into the target treatment area. Additionally, a method for delivering a prosthesis to a target treatment area includes advancing a delivery catheter through a patient's vasculature to the target treatment area, steering the delivery catheter toward the target treatment area, opening a capsule on the delivery catheter, and deploying the prosthesis into the target treatment area.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A61F 2/95 - Instruments specially adapted for placement or removal of stents or stent-grafts
A61F 2/966 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
Methods for the rapid retraction of trans-catheter heart valve delivery systems are provided. A rapid retraction trans-catheter heart valve delivery system comprises a catheter based delivery system. The delivery system has internal mechanisms that allow for the controlled deployment of a heart valve prosthesis, as well as mechanisms that allow for quickly closing the catheter once the heart valve prosthesis has been implanted. This rapid retraction ability allows for reduced procedural durations and thus reduced risk to the patient.
A61M 25/088 - Introducing, guiding, advancing, emplacing or holding catheters using an additional catheter, e.g. to reach relatively inaccessible places
A delivery system for delivering a prosthetic cardiac valve to a patient's heart. The system includes an inner guidewire shaft having a lumen extending therethrough. The lumen adapted to slidably receive a guidewire. The system also includes a hub shaft concentrically disposed over the inner guidewire shaft and a bell shaft slidably and concentrically disposed over the hub shaft. The system further includes a sheath slidably and concentrically disposed over the bell shaft and a handle near a proximal end of the delivery system. The handle includes an actuator mechanism adapted to advance and retract the bell shaft and the sheath.
A delivery system for delivering a prosthetic cardiac valve to a patient's heart, the heart having a mitral valve with an anterior leaflet and a posterior leaflet. The delivery system includes a prosthetic cardiac valve and an inner guidewire shaft having a lumen extending therethrough. The lumen sized to slidably receive a guidewire. The delivery system also includes a distal tissue penetrating tip coupled to a distal portion of the inner guidewire shaft. The distal tip adapted to pass through and expand tissue in the heart. A continuous flared region couples the inner guidewire shaft with the distal tip. The continuous flared region configured to support the prosthetic cardiac valve thereby reducing or eliminating unwanted bending of the prosthetic cardiac valve. The delivery system also includes a hub shaft concentrically disposed over the inner guidewire shaft. The prosthetic cardiac valve is releasably coupled to a distal portion of the hub shaft. The delivery system also includes a bell shaft slidably and concentrically disposed over the hub shaft and an outer sheath slidably and concentrically disposed over the bell shaft. The prosthetic cardiac valve is housed in the outer sheath in a radially collapsed configuration. The delivery system further includes a handle near a proximal end of the delivery system. The handle comprises an actuator mechanism adapted to advance and retract the bell shaft and the sheath.
A61F 2/966 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
77.
METHODS AND APPARATUS FOR ENGAGING A VALVE PROSTHESIS WITH TISSUE
A system for deploying a prosthetic valve. The system includes a prosthetic cardiac valve comprising an atrial skirt, a ventricular skirt, and an anchor tab coupled to the ventricular skirt and a delivery system comprising an outer sheath. The prosthetic cardiac valve is disposed in the outer sheath in a collapsed configuration, and the outer sheath has an inner diameter region and a reduced inner diameter region. Partial retraction of the outer sheath releases the inner diameter region from constraining the atrial skirt and the ventricular skirt thereby allowing self- expansion thereof. Further retraction of the outer sheath releases the reduced inner diameter region from constraining the anchor tab thereby allowing a tip of the tab to radially self-expand outward forming a window between an edge of the atrial skirt and the tip of the anchor tab while the reduced inner diameter region remains engaged with a base portion of the anchor tab such that the tip self-expands to open the window to its maximum size. Further retraction of the outer sheath disengages the reduced inner diameter region from the base portion of the anchor tab thereby releasing a constraint therefrom such that the base of the anchor tab radially expands outward and the tip of the tab moves toward the edge of the atrial skirt, at least partially closing the window.
A61F 2/966 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
A prosthetic cardiac valve which includes an anchor having an atrial skirt, an annular region, and a ventricular skirt. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart. The valve also includes a plurality of prosthetic valve leaflets, each of the leaflets having a first end and a free end. The first end is coupled with the anchor and the free end is opposite of the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The ventricular skirt further comprises a trigonal anchoring tab disposed on an anterior portion of the ventricular skirt, the trigonal anchoring tab adapted to being anchored against a first fibrous trigon on a first side of an anterior leaflet of the patient's mitral valve, such that the anterior leaflet and adjacent chordae tendineae are captured between the trigonal anchoring tab
A prosthetic valve for implanting in a native valve of a patient which includes a self-expanding frame comprising a first end, a second end opposite the first end, an atrial region near the second end, a ventricular region near the first end, an anterior portion, and a posterior portion. The self-expanding frame has an expanded configuration and a collapsed configuration. The expanded configuration adapted to engage tissue at a treatment site and the collapsed configuration adapted to be delivered to the treatment site. The expandable frame includes a self-expanding atrial skirt disposed in the atrial region, a self-expanding ventricular skirt disposed in the ventricular region, a self-expanding annular region disposed between the atrial region and the ventricular region, and a first self-expanding anterior tab disposed on the anterior portion of the self-expanding frame in the ventricular region. The expandable frame also includes a self-expanding foot coupled to the ventricular region. The foot is disposed in the posterior portion and extends radially outward from the self-expanding frame and has an outer surface for engaging the tissue, thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.
A prosthetic delivery system may include a plurality of concentric shafts and an actuator mechanism for actuating one or more of the concentric shafts. A stop mechanism may be coupled to the actuator mechanism. The stop mechanism prevents advancement or retraction of at least some of the shafts beyond a predetermined position unless the stop mechanism is released. A second stop mechanism may be included in the system for controlling another of the shafts. A plurality of filaments may be coupled to a prosthesis carried by the delivery system and actuation of the filaments may be used to control deployment or retrieval of the prosthesis.
A prosthetic valve may be used to repair a diseased or otherwise damaged heart valve such as the mitral valve. The prosthetic valve may include atraumatic anchor tabs which may be radiopaque or echogenic. A cinching mechanism may also be coupled to the prosthetic valve to control radial expansion of the prosthetic valve. The cinching mechanism may include a wire lasso or a belt. The prosthetic valve may include an expandable frame which has a reduced number of strut connection nodes to allow a lower profile collapsed configuration and tighter crimping. The commissure posts of the prosthetic valve may extend beyond an edge of the ventricular skirt portion of the device.
A prosthetic valve may be formed to direct flow out of the outflow orifice toward a posterior portion of a heart wall. The prosthetic valve includes an expandable frame which may be covered with a cover that is suturelessly attached to the frame. The prosthetic valve may also include an outflow orifice size which is controlled. Methods of using these devices are also disclosed.
An introducer sheath includes an elongate shaft having a proximal end, a distal end and a lumen extending therebetween. An actuatable hemostasis valve in a hub is adjacent the proximal end of the elongate shaft and may be used to prevent blood from escaping from the elongate shaft. The introducer sheath may also have a a self-expanding funnel adjacent the distal end of the elongate shaft.
A low-profile prosthetic valve for treating a native valve includes a radially expandable frame having an expanded configuration and a collapsed configuration. The atrial end of the prosthetic valve forms a flared shape that engages an atrial surface of the native valve. The flare shape flares downward toward a ventricle of the native valve when initially expanded followed by inversion of the flared shape to form a tapered shape tapering toward the ventricle and flaring toward the atrium of the native valve when fully expanded. The prosthetic valve also has a plurality of prosthetic valve leaflets that open and close to control fluid flow through the prosthetic valve.
patents
