Abstract:
Implant devices for filtering blood flowing through atrial appendage ostiums have elastic cover and anchoring substructures. The substructures may include reversibly folding tines or compressible wire braid structures. The devices are folded to fit in catheter tubes for delivery to the atrial appendages. The devices elastically expand to their natural sizes when they are expelled from the catheter tubes. Filter elements in the covers block emboli from escaping through the ostiums. The devices with tine substructures may have H-shaped cross sections. These devices seal the appendages by pinching an annular region of ostium tissue between the cover and the anchoring substructures. The shallow deployment depth of these H-shaped devices allows use of an universal device size for atrial appendages of varying lengths. The devices may include remotely activated fixtures for refolding the tines for device recovery or position adjustment.
Abstract:
Catheterization apparatus for implanting devices is provided with a device tether. The apparatus includes a device delivery tube that provides a pathway for moving implant devices through a patient's vasculature to internal body cavities. The implant devices are carried or pushed through the device delivery tube by a tubular push rod. The implant devices are tethered to a line passing through the push rod lumen. After deployment, the implant devices may be retracted into the device delivery tube for repositioning or retrieval by pulling on the tether.
Abstract:
Implant devices for modifying blood flow between an atrial appendage and its associated atrium, are customized for use in subject atrial appendages. The implant devices are tailored to uniquely match individual anatomical characteristics. Cardiac imaging techniques are used to obtain data on the size, shape and orientation of the subject atrial appendage. The raw imaging data is electronically processed using computer modeling to obtain multi-dimensional anatomical images of the subject atrial appendages. Three-dimensional computer aided design tools are used to generate customized device designs from the anatomical images of the subject atrial appendages.
Abstract:
Catheterization apparatus for implanting devices is provided with a device tether. The apparatus includes a device delivery tube that provides a pathway for moving implant devices through a patient's vasculature to internal body cavities. The implant devices are carried or pushed through the device delivery tube by a tubular push rod. The implant devices are tethered to a line passing through the push rod lumen. After deployment, the implant devices may be retracted into the device delivery tube for repositioning or retrieval by pulling on the tether.
Abstract:
Instrumentation for percutaneous delivery of blood filtration devices to atrial appendages includes a curved access sheath (510) and a delivery tube (220). The curved access sheath is coursed through the patient's vasculature to gain transseptal access to a left atrial appendage (11). A compressed filter device (700) attached to a tether wire (410) is loaded in the delivery tube (220). The loaded delivery tube is advanced through the pre-positioned access sheath to place the device in a deployment position. The access sheath (510) and the delivery tube (220) can be mechanically locked and moved together to place the device in a suitable deployment position. The device (700) is deployed by expelling it from the delivery tube (220) either by retracting the delivery tube over the tether wire, or by moving the tether wire forward through the delivery tube. The expelled device, which is not constrained by the delivery tube walls, self expands to its useful size in the subject atrial appendage. A filter membrane (710) in the deployed extends across the appendage ostium (13) to filter blood flow through the ostium. The filter membrane is configured to present a flat surface to atrial blood flow past the ostium.
Abstract:
Instrumentation for percutaneous delivery of blood filtration devices to atrial appendages includes a curved access sheath and a delivery tube. The curved access sheath is coursed through the patient's vasculature to gain transseptal access to a left atrial appendage. A compressed filter device attached to a tether wire is loaded in the delivery tube. The loaded delivery tube is advanced through the pre-positioned access sheath to place the device in a deployment position. The access sheath and the delivery tube can be mechanically locked and moved together to place the device in a suitable deployment position. The device is deployed by expelling it from the delivery tube either by retracting the delivery tube over the tether wire, or by moving the tether wire forward through the delivery tube. The expelled device, which is not constrained by the delivery tube walls, self expands to its useful size in the subject atrial appendage. A filter membrane in the deployed extends across the appendage ostium to filter blood flow through the ostium. The filter membrane is configured to present a flat surface to atrial blood flow past the ostium.
Abstract:
Implant devices for filtering blood flowing through atrial appendage ostiums have elastic cover and anchoring substructures. The substructures may include reversibly folding tines or compressible wire braid structures. The devices are folded to fit in catheter tubes for delivery to the atrial appendages. The devices elastically expand to their natural sizes when they are expelled from the catheter tubes. Filter elements in the covers block emboli from escaping through the ostiums. The devices with tine substructures may have H-shaped cross sections. These devices seal the appendages by pinching an annular region of ostium tissue between the cover and the anchoring substructures. The shallow deployment depth of these H-shaped devices allows use of an universal device size for atrial appendages of varying lengths. The devices may include remotely activated fixtures for refolding the tines for device recovery or position adjustment.
Abstract:
Implant devices for filtering blood flowing through the ostium of an atrial appendage have component structures one or more of which are expandable. Devices with component structures in their unexpanded state have a compact size suitable for intra-cutaneous delivery to an atrial appendage situs. The expandable component structures are expanded in situ to deploy the devices. A device may have sufficiently short axial length so that most or almost all of the device length may fit within the ostium region. An expandable component structure in the device may include a blood-permeable filter element. The device may be deployed so that this component structure covers the ostium so as to direct the blood flow to pass through the filter element. The filter elements used in the devices may have hole size distributions selected to filter out harmful-size emboli. The filter elements may be embedded in elastic material so that hole-size distributions remain substantially unaffected by expansion of the device structures. Anchors attached to a component structure engage tissue surrounding the device and maintain the devices in position. The anchors may include inflatable anchors which engage interior walls of the atrial appendage.
Abstract:
Apparatus for permanent placement across an ostium of a left atrial appendage in a patient, which includes a filtering membrane configured to extend across the ostium of the left atrial appendage. The filtering membrane has a permeable structure which allows blood to flow through but substantially inhibits thrombus from passing therethrough. The apparatus also includes a support structure attached to the filtering membrane which retains the filtering membrane in position across the ostium of the left atrial appendage by permanently engaging a portion of the interior wall of the left atrial appendage. The support structure may be radially expandable from a first configuration to a second configuration which engages the ostium or the interior wall of the left atrial appendage. The filtering membrane may define an opening therethrough that is configured to expand from a first size which inhibits the passage of thrombus therethrough to a second size which allows an interventional device, e.g., an expansion balloon, to pass therethrough, and wherein the opening is resiliently biased towards the first size.
Abstract:
The invention provides a delivery system for placing devices in atrial appendages. The system includes a catheterization apparatus having a tubular structure with one or more nested tubes, wires, and shafts. The tubes establish a passageway for moving a device through a body's vasculature and heart into an atrial appendage. An expandagle positioning guide is disposed on the distal end of a tube passing through the apparatus. The positioning guide is expanded in situ to engage atrial wall surfaces proximate to the atrial appendage for mechanical stabilizes the device delivery passageway. A shaft passing through the tubes transports the device through the passageway to the atrial appendage.