Abstract: A method and system is disclosed for acquiring image data of a subject. The image data can be collected with an imaging system in a selected manner and/or motion. More than one projection may be combined to generate and create a selected view of the subject.

Abstract: A radiation reduction system that includes a computer and an imaging device configured to provide an image of a subject during a medical procedure using electromagnetic radiation. A variety of inputs are accepted from the medical practitioner using the computer such as subject body type, weight, and the like. These user inputs are used by the computer to determine operating settings that are transmitted to the imaging device using a communications link that may be wireless. The calculated settings are useful to generate one or more medically useful images of the subject while significantly reducing the overall radiation exposure to the subject and/or the personnel and/or medical practitioner.

Abstract: Provided is a method for classifying diseases using artificial intelligence (AI) of an electronic apparatus. The method for classifying diseases may comprise obtaining auscultation sound data and auscultation position data, obtaining feature information based on the auscultation sound data and obtaining auscultation position information based on the auscultation position data, generating combined information by combining the feature information and the auscultation position information, and identifying at least one of disease information corresponding to the combined information, by using an AI model.

Abstract: A sonolucent cranial reconstruction device is optimized for trans-cranioplasty ultrasound. The cranial reconstruction device includes a tubular base member and a sonolucent upper wall extending across the top of the tubular base member. The tubular base member is shaped and dimensioned for positioning within an aperture defined by a cranial defect such that bone growth is prevented within the aperture defined by the cranial defect.

Abstract: A system performs a medical procedure in a region of interest of a patient. The system includes an interventional medical device insertable into the region of interest, and a sensor attached to a portion of the interventional device, the sensor being configured to convert an ultrasonic wave from an ultrasound imaging probe to a corresponding electrical radio frequency (RF) signal. The corresponding RF signal is received by a wireless receiver outside the region of interest, enabling determination of a location of the sensor within the region of interest.

Abstract: The present disclosure provides a system and method for fetus monitoring. The method may include obtaining ultrasound data relating to a fetus collected by an ultrasound imaging device; generating a 4D image of the fetus based on the ultrasound data; directing a display component of a virtual reality (VR) device to display the 4D image to an operator; detecting motion of the fetus based on the ultrasound data; and directing a haptic component of the VR device to provide haptic feedback with respect to the motion to the operator.

Abstract: A diaphragm measurement device includes a non-transitory storage medium storing a patient-specific registration model for referencing ultrasound imaging data to a reference frame. At least one electronic processor is programmed to perform a diaphragm measurement method including receiving ultrasound imaging data of a diaphragm of a patient during inspiration and expiration while the patient undergoes mechanical ventilation therapy with a mechanical ventilator; calculating a diaphragm thickness metric based on the received ultrasound imaging data of the diaphragm of the patient referenced to the reference frame using the patient-specific registration model; and displaying, on a display device, a representation of the calculated diaphragm thickness metric.

Abstract: For three-dimensional segmentation from two-dimensional intracardiac echocardiography imaging, the three-dimension segmentation is output by a machine-learnt multi-task generator. Rather than the brute force approach of training the generator from 2D ICE images to output a 2D segmentation, the generator is trained from 3D information, such as a sparse ICE volume assembled from the 2D ICE images. Where sufficient ground truth data is not available, computed tomography or magnetic resonance data may be used as the ground truth for the sample sparse ICE volumes. The generator is trained to output both the 3D segmentation and a complete volume (i.e., more voxels represented than in the sparse ICE volume). The 3D segmentation may be further used to project to 2D as an input with an ICE image to another network trained to output a 2D segmentation for the ICE image. Display of the 3D segmentation and/or 2D segmentation may guide ablation of tissue in the patient.

Abstract: Disclosed is an intraluminal ultrasound imaging system, including a processor circuit in communication with an intraluminal ultrasound imaging catheter, and configured to receive a plurality of intraluminal ultrasound images obtained by the imaging catheter while the imaging catheter is moved through a body lumen of a patient.

Abstract: An ultrasonic catheter is disclosed. The ultrasonic catheter comprises a body having a longitudinal axis and a distal end. A Piezoelectric Micromachined Ultrasonic Transducer (pMUT) array is disposed within the distal end of the body. Further, the pMUT array comprises a plurality of pMUT array elements arranged on a substrate. Further, an insulating material is disposed at the distal end over an imaging window, to provide electrical isolation and transmission of ultrasound signals. The insulating material corresponds to a polyether block amide (PEBA) or Pebax, or thermoplastic elastomer (TPE).

Abstract: Multi-mode capacitive micromachined ultrasound transducer (CMUT) and associated devices systems, and methods are provided. In an embodiment, an intravascular device includes a flexible elongate member having a proximal portion, a distal portion, and a first sensor assembly disposed at the distal portion of the flexible elongate member. The first sensor assembly comprises a first array of capacitive micromachined ultrasonic transducers (CMUTs). The first sensor assembly comprises at least two of a pressure sensor, a flow sensor, or an imaging sensor. In some embodiments, the intravascular device further includes a second sensor assembly comprising a second array of CMUTs.

Abstract: A method provides a source of secondary imaging of an anatomical region of interest for use during a medical procedure. The method is based on acquiring in advance a set of reference images in a secondary imaging modality of the anatomical region over the course of movement of an object or body within the region. Different movement positions of the object within the reference images are indexed via measurement of displacement of a pre-defined reference point fixed relative to the anatomy of interest. This is measured using an ultrasound imaging probe which images the anatomical region simultaneously with the secondary imaging modality. The detected reference point position for each reference image is recorded along with each image frame. During the intervention, an ultrasound image probe is again used, preferably set up in the same position relative to the anatomy, and captures images of the same anatomy during the procedure.

Abstract: An ultrasound includes: an acoustic matching portion disposed on a plurality of piezoelectric elements; and a conductive member disposed on the plurality of piezoelectric elements and adjacent to the acoustic matching portion, in which the conductive member includes a conductor layer having a multi-layer structure, which is disposed on at least one end side of the acoustic matching portion in a second direction intersecting the first direction, the conductor layer having a multi-layer structure includes a plurality of first conductor layers respectively bonded to the second conductive portions of the piezoelectric elements, and a second conductor layer laminated on the plurality of first conductor layers and electrically connects the plurality of first conductor layers, and a ratio of a thickness to a width, which is a length in the first direction, of the first conductor layer is 1.6 or less.

Abstract: An ultrasonic imaging system is disclosed. The ultrasonic imaging system comprises an ultrasonic catheter having a longitudinal axis, a proximal end, and a distal end. The ultrasonic imaging system includes an ultrasonic transducer array disposed within the distal end of the ultrasonic catheter. The ultrasonic transducer array comprises a plurality of transducer array elements arranged on a substrate. Further, a catheter shaft is connected at one end to a handle assembly and at other end to the ultrasonic transducer array. The catheter shaft houses an electronic flex cable which is in communication with at least one signal trace, and is configured to direct each of the plurality of transducer array elements to transmit and receive ultrasound beams, receive at least one signal from the plurality of transducer array elements, and construct at least one image of at least a portion of the heart based on the at least one signal.

Abstract: According to one embodiment, the ultrasonic probe includes a transducer group, an acoustic transmission layer, and a protective material. The transducer group has a plurality of transducers transmitting ultrasonic waves. The acoustic transmission layer transmits the ultrasonic waves transmitted by the transducer group. The protective material protects the transducer group and the acoustic transmission layer. A width of the transducer group in an elevation direction and an opening width of the protective material at the position corresponding to the body contact surface of the acoustic transmission layer are almost identical. The transducer group is provided at a predetermined distance from the body contact surface of the acoustic transmission layer.

Abstract: A detection probe, a transmission apparatus, and a detection device are provided. The detection probe includes a housing, a detection mechanism, a driving mechanism, and a rope transmission mechanism. The housing defines an accommodation space. The detection mechanism is arranged on one end of the housing, and is configured to perform a detection function. The driving mechanism is arranged in the accommodation space, and is configured to output a force. The rope transmission mechanism is arranged in the accommodation space, and includes a rope set and a tension member. One end of the rope set is connected to the driving mechanism, and other end of the rope set is connected to the detection mechanism. The tension member is connected to the rope set, and is configured to apply a force to one end of the rope set away from the detection mechanism.

Abstract: An ultrasound endoscope includes: an ultrasound transducer including a piezoelectric element that includes a plurality of grooves with a groove filling material filled in the plurality of grooves, the groove filling material including the following (1) to (3): (1) an epoxy resin; (2) at least one filler selected from the group consisting of diamond, aluminum oxide, silicon oxide, silicon carbide, boron carbide, iron oxide (III), chromium oxide (III), and cubic boron nitride; and (3) an aliphatic diol diglycidyl ether.

Abstract: A diagnostic facility is described. The facility accesses a set of trained machine learning models. For each of a plurality of stages of a diagnostic ultrasound protocol for blood vessels, the facility causes an ultrasound device to capture from the person an ultrasound artifact of a type specified for the stage that features a blood vessel specified for the stage; applies one of the trained machine learning models to the captured ultrasound artifact to produce a prediction; and determines a score for the stage based at least in part on the produced prediction. The facility combines the determined scores to produce a diagnosis grade for the person.

Abstract: The present disclosure provides systems and methods for predicting a disease state of a subject using ultrasound imaging and ancillary information to the ultrasound imaging. At least two quantitative measurements of a subject, including at least one measurement taken using ultrasound imaging, as part of quantified information can be identified. One of the quantitative measurements can be compared to a first predetermined standard, included as part of ancillary information to the quantified information, in order to identify a first initial value. Further, another of the quantitative measurements can be compared to a second predetermined standard, included as part of the ancillary information, in order to identify a second initial value. Subsequently, the quantitative information can be correlated with the ancillary information using the first initial value and the second initial value to determine a final value that is predictive of a disease state of the subject.

Abstract: Disclosed is a method for operating an ultrasound diagnostic apparatus, comprising the steps of: acquiring a first ultrasound image of an object; detecting a first nerve region corresponding to a first target nerve in the first ultrasound image; determining whether an abnormal region is present in the first nerve region of the first ultrasound image, on the basis of a determination standard for determining whether a target nerve is abnormal; and on the basis of a result of determining whether an abnormal region is present in the first nerve region, displaying at least one of information on the abnormal region and basis information regarding the basis for determining the abnormal region as abnormal.

Abstract: An ultrasound diagnostic apparatus according to an embodiment includes image processing circuitry. The image processing circuitry acquires, based on a result of ultrasound scanning performed on a subject, blood flow information including a value that indicates a blood flow at each position within the subject and tissue property information including a value that indicates tissue properties at each position within the subject. The image processing circuitry generates a first image in which a difference in value in the blood flow information is represented by at least a difference in hue and a second image in which a difference in value in the tissue property information is represented by a difference other than the difference in hue. The image processing circuitry generates a combined image by combining the first image and the second image.

Abstract: Ultrasound image devices, systems, and methods are provided. An intraluminal ultrasound imaging system, comprising a patient interface module (PIM) in communication with an intraluminal imaging device comprising an ultrasound imaging component, the PIM comprising a first reconfigurable logic block including a first plurality of logic elements interconnected by first reconfigurable interconnection elements; a configuration memory coupled to the first reconfigurable logic block; and a processing component coupled to the configuration memory, the processing component configured to detect a device attribute of the intraluminal imaging device in communication with the PIM; and load at least one of a first configuration or a second configuration to the configuration memory based on the detected device attribute to configure one or more of the first reconfigurable interconnection elements such that the first plurality of logic elements are interconnected for communication with the ultrasound imaging component.

Abstract: The present invention solves a conventional problem that it is not possible to predict menstruation-related information related to menstruation using abdominal sounds. A menstruation-related information output apparatus includes: a learning information storage unit in which learning information configured using two or more pieces of training data having sound information acquired from abdominal sounds of a user and menstruation-related information related to menstruation is stored; a sound information acquiring unit that acquires sound information from abdominal sounds of the user; a predicting unit that applies the learning information to the sound information acquired by the sound information acquiring unit, thereby acquiring menstruation-related information; and an output unit that outputs the menstruation-related information acquired by the predicting unit. Accordingly, it is possible to predict menstruation-related information using abdominal sounds from the abdomen.

Abstract: A biopsy needle arrangement comprises a needle sheath and a needle configured to lock a tip portion of the needle in relation to the sheath when the needle arrangement has obtained a closed state. The locking, which is obtained by configurations of sheath opening edges and proximal tip edges, between the tip portion of the needle and the sheath is in a third direction as well as in a rotational sense in that the tip cannot rotate around a longitudinal axis defined by a first direction.

Abstract: The present disclosure provides a biopsy device for performing soft tissue biopsy on any major organ through the venous system, and a method for using the biopsy device. The biopsy device of the present disclosure is a system that is sufficiently flexible such that the system can be guided manually and with existing tools i.e., fluoroscopy for visualisation and simple guidewires. Once in place, the biopsy device of the present disclosure can generate enough force and can transmit that force to the distal cutting end of the system to penetrate the organ and obtain a biopsy.

Abstract: The present disclosure provides a catheter for insertion into a subject and navigation to a target organ, the catheter comprising: a first elongated tube and a second elongated tube; the first elongated tube having a first lumen with a first proximal end and a first distal end; and the second elongated tube having a second lumen with a c-shaped cross section forming a channel with a second proximal end and a second distal end, the second elongated tube sharing a common wall with the first elongated tube.

Abstract: A tool adapter (18), consisting of an adapter arm (102) having a proximal end terminating with a connection (110) and a distal end having a circular coupling (104), the circular coupling having a center and defining an axis (114) orthogonal to the circular coupling and passing through the center. The adapter also has a tool grip (32) rotatingly connected to the circular coupling so as to permit rotation of the tool grip about the axis, the tool grip being configured to fixedly retain a tool (16) along the axis.

Abstract: A device for applying adhesive composition to biological tissue and/or prosthetic material includes a flexible body, wherein the body has an upper surface that includes a first shoulder defining a first recess. The body is adapted to be folded on itself in a folded position in which the body defines a channel and in which the first recess forms an annular gap between the upper surface and the biological tissue and/or prosthetic material when the biological tissue and/or prosthetic material is positioned in the channel.

Abstract: The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal. The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Abstract: A vascular closure device includes a release component, a delivery component, a sealing device and at least one actuator. The release component is elongate along a longitudinal direction, and defines a distal end and a proximal end. The delivery component extends along the release component such that at least the release component is movable relative to the delivery component. The delivery component includes a delivery tube body and defines a delivery tube channel. The sealing device has a toggle that is at least partially disposed within the release tube, a suture that is attached to the toggle and extends through the delivery tube channel, and a plug that is attached to the suture proximal to the toggle.

Abstract: A retractor member includes a body portion extending along a longitudinal axis and being at least partially defined by a first lateral perimeter edge and a second lateral perimeter edge that each extends parallel to the longitudinal axis. The body portion additionally includes an upper surface and a lower surface that each extends between the first lateral perimeter edge and the second lateral perimeter edge. A first lateral support portion is coupled to the body portion at a first location at or adjacent to the first lateral perimeter edge, and a second lateral support portion is coupled to the body portion at a second location at or adjacent to the second lateral perimeter edge. A first coupling portion is disposed at a top end portion of the first lateral support portion and a second coupling portion is disposed at a top end portion of the second lateral support portion.

Abstract: A catheter device for repair of the heart by implanting an artificial chordae line, a method of use of a catheter device for repair of the heart by implanting an artificial chordae line, and a method of manufacture of a catheter device for repair of the heart by implanting an artificial chordae line are described.

Abstract: A tissue anchor includes a central body extending between a first lengthwise end and a second lengthwise end. A first arm extends outwardly from the central body, and a second arm extends outwardly from the central body and spaced from the first arm. The tissue anchor is movable between a collapsed state and a deployed state. In the collapsed state, the central body extends linearly from the first lengthwise end to the second lengthwise end of the central body along an axis and the first and second arms extend parallel to the axis. In the deployed state, the central body extends non-linearly and the first and second arms extend radially outwardly from the central body.

Abstract: Systems and methods for tissue repair are illustrated and described. One such system optionally includes any one or combination of: one or more sutures, a suture anchor configured to couple with the one or more sutures and a prosthesis. The prosthesis can optionally be configured to be inserted in a bone of a patient. The prosthesis can have a first surface and at least one passage therein. The at least one passage can have a first opening at the first surface and a second opening. The suture anchor can be configured to couple with the prosthesis at one or more of the first surface or the at least one passage. The one or more sutures can be configured to pass through the prosthesis via the at least one passage.

Abstract: Disclosure herein are knotless suture anchor constructs and methods of use thereof. The suture anchor constructs can include a bone anchor and a suture. The bone anchor can include a suture anchoring member and can define a cavity and a longitudinal passage extending from a trailing end of the bone anchor at least partially therethrough to the cavity. The suture anchoring member can be located in the cavity. The suture can be coupled to the suture anchoring member and can include a tensioning portion, a repair portion, and an intermediate portion. The intermediate portion can form a suture loop extending along the longitudinal passage.

Abstract: A suturing device with built-in needle-transfer of a double-ended needle has a first jaw element with a first needle lock device for retaining and releasing a first end of the needle; a second jaw element with a second needle lock device, wherein the jaw elements are movable between an open and closed position; and a needle-transferring mechanism for alternately transferring the needle from one of the jaw elements to the other when the jaws are moved from the open to the closed position. The needle-transferring mechanism includes a first rotatable wheel connected to the first needle lock device, the first wheel having a first wheel inner portion rigidly connected to a first wheel outer portion and a second rotatable wheel connected to the second needle lock device, said second rotatable wheel comprising a second wheel inner portion rigidly connected to a second wheel outer portion.

Abstract: A surgical stapling apparatus (stapler) including a housing, elongated member, and a reload is disclosed. A cartridge is configured to selectively couple to a first jaw member of the reload and includes one or more resilient members thereon. An anvil operably supported on a second jaw member of the reload is configured to compress one or more fasteners ejected from the cartridge. The anvil includes one or more locking members thereon. A knife is configured to translate through the cartridge and anvil when the first and second jaw members are in a closed configuration. Engagement between the knife and the resilient member(s) causes the resilient member(s) to move from an initial configuration that allows the knife to travel distally past the locking member(s) to a final configuration that allows the locking member(s) to engage the knife.

Abstract: A surgical instrument can comprise a handle, a motor, and a shaft extending from the handle. The handle and/or the shaft can define a longitudinal axis. The surgical instrument can further comprise a fastener cartridge comprising a plurality of fasteners removably stored therein, an anvil configured to deform the fasteners, a closure drive configured to move the anvil toward and away from the fastener cartridge which is rotatable about the longitudinal axis, and a firing drive configured to deploy the fasteners from the fastener cartridge which is rotatable about the longitudinal axis. The surgical instrument can further comprise a transmission comprising a first operating configuration which connects the motor to the closure drive and a second operating configuration which connects the motor to the firing drive.

Abstract: A powered handle assembly includes a motor assembly, a rack, a spur gear, and a manual retract mechanism. The spur gear is movable from a position engaged with the motor assembly and the rack to a positioned disengaged from the motor assembly and engaged with the rack to facilitate manual retraction of the rack.

Abstract: The present disclosure includes apparatuses for a surgical handle assembly. An example apparatus includes a reloadable cartridge assembly and a surgical handle assembly including an articulation assembly configured to maintain the reloadable cartridge assembly in a first operation position, the articulation assembly comprising a knob in a first position, a lock core coupled to the knob, a housing, a first roller and a second roller, and a first spring, wherein the first roller is positioned on a first end of the first spring and the second roller is positioned on a second end of the first spring, and wherein the first spring is configured to bias the first roller and the second roller between the lock core and the housing to maintain the knob in the first position.

Abstract: A surgical system includes a control circuit, a surgical instrument, and a user interface is disclosed. The surgical instrument includes a plurality of components and a sensor. Each of the plurality of components of the surgical instrument includes a device parameter and is configured to transmit its respective device parameter to the control circuit. The sensor of the surgical instrument is configured to detect a tissue parameter associated with a proposed function of the surgical instrument, and transmit the detected tissue parameter to the control circuit. The control circuit is configured to analyze the detected tissue parameter in cooperation with each respective device parameter based on a system-defined constraint. The user interface is configured to indicate whether the surgical instrument comprising the plurality of components is appropriate to perform the proposed function.

Abstract: Surgical stapling instruments include mechanisms for identifying and/or deactivating stapler cartridges for use with the instruments. The stapling instrument includes a drive member for actuating a staple cartridge and a locking member movable from a disabled position permitting distal translation of the drive member through a staple firing stroke, to a locking position inhibiting distal translation of the drive member through the staple firing stroke. The staple cartridge may include a switch movable in a lateral direction to either maintain the locking member in the disabled position or to allow the locking member to move into the locking position. The instrument may further include a stapler cartridge including an annular pin configured to be engaged by a drive member at a an axial position to create a detectable resistance for reload detection by a control unit to identify the type of stapler cartridge present in the surgical stapling instrument.

Abstract: A surgical instrument comprising an articulatable end effector and an articulation control system is disclosed. The articulation control system comprises actuators that, when actuated, cause the end effector to articulate in predetermined directions. When the end effector is rotated downwardly, the articulation control system flips, or switches, the response to the inputs from the actuators.

Abstract: A surgical device includes a jaw assembly, an articulating assembly and a drive shaft. The jaw assembly includes first and second jaws. The articulating assembly is removably coupled to a proximal end of the jaw assembly and includes a distal joint member, a proximal joint member, and a pivot pin. The pivot pin is fixedly coupled to the distal joint member and is rotatably coupled to the proximal joint member. The jaw assembly and the distal joint member together define a first longitudinal axis. The proximal joint member defines a second longitudinal axis. The drive shaft includes a gear element that is meshingly engaged with a pivoting gear element that is fixedly coupled to the pivot pin. Longitudinal movement of the first drive shaft pivots the jaw assembly relative to the proximal joint member about a pivot axis defined by the pivot pin.

Abstract: An anastomosis protection device is provided, including: a protective sleeve located inside a tubular tissue and positioned correspondingly to the anastomotic stoma; at least one fixing assembly, wherein the fixing assembly comprises at least one first fixing member and at least one second fixing member, wherein the first fixing member is provided on an outer wall of the tubular tissue, the second fixing member is provided on an inner surface of the protective sleeve and positioned correspondingly to the first fixing member, and the first fixing member and the second fixing member being relatively fixed by means of magnetic attraction. The device provides an extension and retraction space for the tissue.

Abstract: Apparatuses for placement of magnetic therapeutic devices are provided. Such apparatuses may include an actuation mechanism that includes a movable portion that is movable relative to another portion thereof between at least three different predetermined relative locations, each location associated with a different position of a magnet located within a therapeutic device interface of the apparatus. By moving the magnet between the different locations relative to the therapeutic device interface, different amounts of magnetic clamping force between the magnet and a therapeutic device interfaced with the therapeutic device interface may be developed.

Abstract: A method for adaptive control of surgical network control and interaction is disclosed. The surgical network includes a surgical feedback system. The surgical feedback system includes a surgical instrument, a data source, and a surgical hub configured to communicably couple to the data source and the surgical instrument. The surgical hub includes a control circuit. The method includes receiving, by the control circuit, information related to devices communicatively coupled to the surgical network; and adaptively controlling, by the control circuit, the surgical network based on the received information.

Abstract: A surgical device includes a handle assembly having a power source; a motor coupled to the power source; and a controller configured to control the motor. The surgical device also includes an adapter assembly configured to selectively couple to the handle assembly; a reload configured to selectively couple to a distal portion of the adapter assembly, the reload including a plurality of fasteners; and an anvil assembly selectively couplable to the distal portion of the adapter assembly, the anvil assembly being movable relative to the reload. The controller is further configured to control the motor to move the anvil assembly from a starting position to a compressed position thereby compressing tissue at a target clamping force between the anvil assembly and the reload.

Abstract: Methods and systems for inverting and closing a left atrial appendage. The system can include a vacuum tube, closed-end needle, and tissue glue. The vacuum tube may have a plunger-like end for attachment to the left atrial appendage and may also be capable of attaching to a vacuum source. The method can comprise the steps of attaching the vacuum tube to the left atrial appendage, advancing a closed-end needle through the left atrial appendage, retracting the vacuum tube to invert the left atrial appendage, and injecting tissue glue through the closed-end needle so that the exterior sides of the left atrial appendage are glued together and the appendage will fibrous and atrophy over time, thereby eliminating formation of a thrombus within the apex of the atrial appendage.

Abstract: An implantable medical device such as but not limited to a left atrial appendage closure (LAAC) device includes an expandable frame that is movable between a collapsed configuration for delivery and an expanded configuration for deployment, the expandable frame including a proximal portion, a distal portion and an intervening intermediate portion. The expandable frame includes a plurality of anchors extending about a periphery of the expandable frame. A primary covering extends over the proximal portion of the expandable frame and may interact with the plurality of anchors. A secondary covering extends over part of the expandable frame.