A prosthetic heart valve may include an expandable frame with an anchoring section and a valve support section. The anchoring section may form a row of cells, two adjacent cells being joined together by a runner extending in a longitudinal direction. The anchoring section may include a plurality of commissure attachment features ("CAFs"), a first one of the CAFs features being axially aligned with the runner. Prosthetic leaflets may be mounted within the frame. A first pair of the plurality of prosthetic leaflets may be coupled together to form a first prosthetic commissure attached to the first one of the CAFs. A radiopaque marker may have a longitudinal section extending between a first end section and a second end section, and be coupled to the runner so that the longitudinal section is axially aligned with both the runner and the first one of the plurality of commissure attachment features.
An elongate medical device having a device longitudinal axis and a device distal region, the medical device comprising a balloon at the device distal region and having a balloon longitudinal axis, the balloon comprising a balloon inflatable portion with a first length configured to transition from a deflated state to an inflated state and includes a portion of the balloon proximal portion and a portion of the balloon distal portion, a balloon proximal portion with a second length, a balloon distal portion with a third length, wherein, in the inflated state, the balloon is symmetrical about the balloon longitudinal axis and the balloon comprises a first profile shape with a second length and a second profile shape with a third length, and wherein the balloon distal portion comprising the second profile shape comprises a tissue contacting surface where a substantial portion of the tissue contacting surface is concave.
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/02 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
A61B 18/24 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor with a catheter
3.
SYSTEM AND METHOD FOR LOCAL ELECTROPHYSIOLOGICAL CHARACTERIZATION OF CARDIAC SUBSTRATE USING MULTI-ELECTRODE CATHETER
A system for determining electrophysiological data comprising an electronic control unit configured to acquire electrophysiology signals from a plurality of electrodes (130) of one or more catheters, select at least one clique of electrodes from the plurality of electrodes (136) to determine a plurality of local E field data points, determine the location and orientation of the plurality of electrodes, process the electrophysiology signals from the at least one clique from a full set of bipole subcliques to derive the local E field data points associated with the at least one clique of electrodes, derive at least one orientation independent signal from the at least one clique of electrodes (138) from the information content corresponding to weighted parts of electrogram signals, and display or output catheter orientation independent electrophysiologic information to a user or process.
A prosthetic heart valve may include an expandable frame with an anchoring section and a valve support section. The anchoring section may form a row of cells, two adjacent cells being joined together by a runner extending in a longitudinal direction. The anchoring section may include a plurality of commissure attachment features (“CAFs”), a first one of the CAFs features being axially aligned with the runner. Prosthetic leaflets may be mounted within the frame. A first pair of the plurality of prosthetic leaflets may be coupled together to form a first prosthetic commissure attached to the first one of the CAFs. A radiopaque marker may have a longitudinal section extending between a first end section and a second end section, and be coupled to the runner so that the longitudinal section is axially aligned with both the runner and the first one of the plurality of commissure attachment features.
An electroanatomical mapping system receives a plurality of electrophysiology signals (e.g., unipolar electrograms) measured by electrodes within a clique of electrodes on a multi-electrode catheter. Each signal includes a component of interest and at least one common far-field noise component. The system generates a plurality of reference signals and then computes a weight vector including a plurality of weights, with each weight maximizing separation between the component of interest and the common far-field noise components in a respective electrophysiology signal. The system then applies the weight vector to the electrophysiology signals to output a plurality of denoised electrophysiology signals, each exhibiting less of the common far-field noise component(s) than the respective electrophysiology signal prior to denoising.
A61B 5/287 - Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A61B 5/316 - Modalities, i.e. specific diagnostic methods
A61B 5/318 - Heart-related electrical modalities, e.g. electrocardiography [ECG]
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
In some examples, an introducer sheath (400) extends from a proximal end (402) to a distal end (404), and includes a hub (405) disposed at the proximal end, and a body (410) coupled to the hub and extending between the proximal end and the distal end, the body defining a lumen (420) and having a collapsed condition and an expanded condition, the body having a braided material (412) and an elastomeric material (414) covering the braided material, the body having a flared distal end (422).
Data collected by an electrophysiology catheter during an ablation procedure. such as a pulmonary vein isolation, can be visualized using an electroanatomical mapping system. The mapping system receives data points measured by the catheter, each of which includes localization information and at least one procedure metric. The system then applies an ablation procedure model to the data points. The model facilitates relating the data points to one or more anatomical features using the localization data and/or relating the data points to an ablation procedure outcome using the metric(s). This allows the system to generate map(s) of the metric(s) and output visualization(s) of the map(s). The visualization(s) can include two-dimensional schematic anatomical representation(s) of the metric(s) and/or two-dimensional representation(s) of the metric(s) versus time. Various metrics, including, but not limited to, contact angle, contact force, and catheter stability, can be visualized.
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
In some examples, an introducer sheath extends from a proximal end to a distal end, and includes a hub disposed at the proximal end, and a body coupled to the hub and extending between the proximal end and the distal end, the body defining a lumen and having a collapsed condition and an expanded condition, the body having a braided material and an elastomeric material covering the braided material, the body having a flared distal end.
A catheter includes an elongate shaft, an electrode assembly, a connective stem, a coupler, a first magnetic position sensor, and a second magnetic position sensor. The electrode assembly includes microelectrodes. The connective stem includes a first connective stem member and a second connective stem member. The connective stem defines a first sensor receptacle and a second sensor receptacle in an exterior surface of the connective stem. The coupler is configured for coupling with the connective stem. The first magnetic position sensor is disposed in the first sensor receptacle and elongated along a first sensor longitudinal axis. The second magnetic position sensor disposed in the second sensor receptacle and elongated along a second sensor longitudinal axis that is not parallel to the first sensor longitudinal axis.
A medical device comprising a first shaping element, a second shaping element located distally with respect to the first shaping element, a support structure that extends between the first and the second shaping elements, where each of the first and the second shaping element s are transversely oriented with respect to a longitudinal axis that extends through a center of each shaping element, and a plurality of interactive elements. An apparatus for an elongate medical device comprising a flexible planar substrate, a support structure, and a plurality of interactive elements. A helical medical device comprising a first planar substrate, wherein the first planar substrate has a helical shape and a second planar substrate coupled with the first planar substrate, wherein the second planar substrate includes a plurality of interactive elements.
A delivery device for delivering a pacing lead to a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal end face, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position exposed on or spaced from the distal end face. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a substantially straight configuration to a dual hinged curved configuration that maneuvers and positions the electrodes in the vicinity of the bundle of His. The sheath may include a PTFE liner having axially oriented, platelet-like fibril features that enable the sheath to be split along its length from a proximal end to the distal end.
A prosthetic heart valve includes a non-collapsible annular frame extending in a longitudinal direction between an inflow edge and an outflow edge, and a valve assembly connected to the frame. The frame includes a plurality of annularly spaced commissure posts adjacent the outflow edge, each of the commissure posts including a tip and a post slot spaced apart from the tip. The prosthetic heart valve further includes a radiopaque element including an elongated main body having a first end and a second end. The radiopaque element may extend around the tip and through the post slot of at least one of the commissure posts so that a portion of the main body extends between the slot and the tip. Alternatively or additionally, a radiopaque element may be positioned adjacent a base of the frame.
A prosthetic heart valve for replacing a native valve includes a stent, a valve assembly, and a radiopaque element. The stent has a plurality of commissure attachment features. The valve assembly includes a plurality of leaflets and first and second cuffs. The first cuff has a proximal edge relatively close to the inflow end of the stent. The second cuff may be annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The proximal edge of the first cuff is coupled to the proximal edge of the second cuff substantially continuously along a circumference of the inflow end of the stent so that a pocket is formed between the first cuff and the second cuff. The radiopaque element is disposed within the pocket and aligned in a longitudinal direction of the stent with at least one of the plurality of commissure attachment features.
A medical device includes a body and at least one electrode disposed thereon. The electrode includes a metallic substrate, such as a platinum group metal, an alloy of platinum group metals, or gold. The surface of the substrate is modified in a manner that increases its effective surface area without inducing bulk heating. For example, the surface of the substrate can be laser textured and/or coated, such as with titanium nitride or iridium oxide.
Various embodiments of the present disclosure can include a flexible catheter tip. The flexible catheter tip can comprise an inboard understructure that defines a tip longitudinal axis, wherein the inboard understructure is formed from a first continuous element that includes a first rectangular cross-section. In some embodiments, an outboard understructure can extend along the tip longitudinal axis, wherein the outboard understructure is formed from a second continuous element that includes a second rectangular cross-section.
An electrode assembly includes an electrode pair including a first electrode and a second electrode configured to be selectively energized for delivery of electroporation therapy. The electrode assembly also includes an expandable isolation member disposed axially between the first electrode and the second electrode. One of the first electrode and the second electrode is positioned proximally of a proximal end of the expandable isolation member and the other of the first electrode and the second electrode is positioned distal to a distal end of the expandable isolation member. The expandable isolation member is configurable between a collapsed configuration and an expanded configuration. The expandable isolation member includes a circumferential sealing surface configured for sealing engagement with tissue of a patient such that the expandable isolation member inhibits fluid and electrical communication between the first electrode and the second electrode when engaged with the tissue.
A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent, a plurality of prosthetic valve leaflets each having a belly attached to the cuff between a first location and a second location downstream of the first location in a flow direction, and a sealing structure attached to the annulus section of the stent. The annulus section of the stent may be adjacent the proximal end. The stent may include a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent. The sealing structure may have a deployed condition with a diameter greater than a diameter of the proximal end of the stent when the stent is in an expanded use condition.
Described herein is a medical device for treating a target site, the medical device including, a proximal end including a disc and a distal end including a lobe. The disc and the lobe are connected by a connecting member. The lobe includes a proximal portion defining a proximal surface of the lobe, a distal portion defining a distal surface of the lobe, and a middle portion connecting and extending between the proximal portion and the distal portion. A first transition between the proximal portion and the middle portion is curved, and a second transition between the middle portion and the distal portion is curved. The medical device also includes a plurality of stabilizing wires coupled to the lobe at a radially outer surface of the middle portion, each stabilizing wire including a hook portion extending radially outward from the at least one lobe.
A prosthetic heart valve includes a collapsible and expandable stent having a plurality of cells including a lowermost row of cells, a valve including an inner cuff, and a plurality of leaflets secured to the stent, and an outer cuff at least partially covering the lowermost row of cells, the outer cuff having a bottom edge, a top edge, and a plurality of axially projecting arms extending from the top edge, the outer cuff being attached to at least one cell at two side vertices and a bottom vertex to form at least one parachute, and to an upper vertex of the at least one cell via at least one of the plurality of axially projecting arms.
An apparatus for detecting relative positioning of medical devices located within a human body, the apparatus comprising an inner elongate member comprising a plurality of electrodes and a first sensor member, where the first sensor member is located a known distance from each of the plurality of electrodes, and an outer elongate member comprising a first sensor, and an outer sensor member located between the first sensor and an inner wall of the outer elongate member, where the inner elongate member is configured to move within the outer elongate member and the first sensor is configured to sense a signal generated by movement of the inner elongate member relative to the outer elongate member, and a position detection module including an electronic control unit configured to detect a position of the first sensor member relative to the first sensor based on the signal.
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/287 - Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
A61B 8/12 - Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/02 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
A prosthetic heart valve includes a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets. Each leaflet is formed from a predetermined leaflet material. Some leaflet materials include a metal body with a plurality of openings. The metal body may be coated with a polymer. Other leaflet materials include natural mammalian tissue subjected to a plastination preservation process.
The present invention generally relates to expandable catheters for use in electrophysiology, and more specifically to high-density balloon catheters for use in diagnosing and/or treating cardiac arrhythmias. A catheter includes an elongate catheter shaft comprising a proximal end and a distal end. The elongate catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second deployed configuration. The balloon member includes at least one flexible framework disposed between an outer facing layer and an inner facing layer of the top surface and/or the bottom surface of the balloon member and at least one plurality of electrodes patterned onto the flexible framework. In some embodiments, a flat balloon member includes electrodes on both sides of the planar balloon member. The balloon member may include a flexible structural element disposed within the interior cavity.
A catheter including a catheter shaft and a mapping balloon configured for navigation within a body. The mapping balloon can be coupled to the catheter shaft, such as at a distal end of the catheter shaft. The mapping balloon can have an exterior surface including a plurality of predefined fold locations configured to allow the mapping balloon to be adjusted between a collapsed configuration and an expanded configuration. In the collapsed configuration, the mapping balloon can include a first dimension, and in the expanded configuration the mapping balloon can have a second dimension. The second dimension can be greater than the first dimension. A plurality of electrodes can be located along the exterior surface of the mapping balloon to communicate electrical signals with an electronic control unit.
A prosthetic heart valve may include a balloon-expandable frame formed of a plastically-expandable material, and a self-expanding frame formed of a self-expanding material, the self-expanding frame including a plurality of commissure attachment features. The valve may include a plurality of prosthetic leaflets, wherein pairs of adjacent prosthetic leaflets form commissures, each of the commissures being coupled to a corresponding one of the plurality of commissure attachment features. The balloon-expandable frame may be coupled to the self-expanding frame to form a hybrid frame, the hybrid frame including an inflow end and an outflow end, the balloon-expandable frame being positioned at the inflow end of the hybrid frame, and the self-expanding frame being positioned at the outflow end of the hybrid frame.
According to one aspect of the disclosure, a prosthetic heart valve system includes a collapsible and expandable prosthetic atrioventricular valve including an atrial disk, a ventricular disk, a center portion, and a plurality of prosthetic leaflets. The system may include a delivery device that includes a catheter having a valve cover configured to maintain the prosthetic heart valve in a collapsed condition for delivery. The delivery device may include an expansion restriction mechanism and a shaft system including an atrial tube and a ventricular tube. In a delivery condition, the prosthetic heart valve is collapsed within the valve cover and pluralities of sutures may connect the atrial and ventricular tubes to the atrial and ventricular disks, respectively, to restrict and control the expansion of the ends of the prosthetic heart valve.
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 method of detecting whether an external wire is connected to an input terminal of an electrical system includes monitoring a signal associated with the input terminal, converting the analog signal to a digital signal, and processing the digital signal through Fast Fourier Transform (FFT). The method further includes detecting whether an external cable is connected to the input terminal based on the spectral content derived from the FFT. The method can include generating a notification if an external wire is detected and implementing safety protocols that allow or prohibit delivery of electrical power to one or more external components, based on whether the external wire is detected. In an example, the electrical system is part of a medical system, and the external wire can be configured for attachment of a catheter.
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
Multi-electrode ablation systems, methods, and controllers are described. In one example, a method of beginning an ablation procedure using a multi-electrode ablation system is described. The method includes selectively coupling the output of a power supply to a first electrode of a plurality of electrodes to increase a temperature at the first electrode to a first temperature set-point and limit a rate of increase of the temperature at the first electrode to a predetermined first rate.
A61B 18/08 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A method of detecting whether an external wire is connected to an input terminal of an electrical system includes monitoring a signal associated with the input terminal, converting the analog signal to a digital signal, and processing the digital signal through Fast Fourier Transform (FFT). The method further includes detecting whether an external cable is connected to the input terminal based on the spectral content derived from the FFT. The method can include generating a notification if an external wire is detected and implementing safety protocols that allow or prohibit delivery of electrical power to one or more external components, based on whether the external wire is detected. In an example, the electrical system is part of a medical system, and the external wire can be configured for attachment of a catheter.
A respiration signal can be generated within electroanatomical mapping system from the non-driven impedance signals received from a plurality of patch electrodes. The non-driven impedance signals are used to define a reference respiration signal. Each of a subset of the non-driven impedance signals can then be compared to the reference respiration signal to determine a polarity value; a scaling factor can also be computed that normalizes the non-driven impedance signals. The polarity values and scaling factors are applied to the non-driven impedance signals to generate weighted non-driven impedance signals, which can then be summed into a composite respiration signal. The composite respiration signal can, in turn, be subject to its own polarity value and scaling factor for use in real time (e.g., for gating data collection, respiration compensation, detection of irregular respiration, and the like).
Aspects of the present disclosure are directed to flexible high-density mapping catheters with a planar array of high-density mapping electrodes near a distal tip portion. These mapping catheters may be used to detect electrophysiological characteristics of tissue in contact with the electrodes, and may be used to diagnose cardiac conditions, such as cardiac arrhythmias for example.
A method of determining impedance for a plurality of electrodes on a medical device includes applying a first drive signal between a first pair of adjacent electrodes in the plurality of electrodes and applying a second drive signal between a second pair of adjacent electrodes in the plurality of electrodes. Because the pairs of electrodes are overlapping, the first and second pair of adjacent electrodes include a common electrode. The method further includes applying additional drive signals between additional pairs of adjacent electrodes and measuring an impedance for each pair of adjacent electrodes. The measured impedances can be used to determine contact status or tissue proximity, as well as to detect a faulty electrode or a faulty circuit in the plurality of electrodes.
A method of determining impedance for a plurality of electrodes on a medical device includes applying a first drive signal between a first pair of adjacent electrodes in the plurality of electrodes and applying a second drive signal between a second pair of adjacent electrodes in the plurality of electrodes. Because the pairs of electrodes are overlapping, the first and second pair of adjacent electrodes include a common electrode. The method further includes applying additional drive signals between additional pairs of adjacent electrodes and measuring an impedance for each pair of adjacent electrodes. The measured impedances can be used to determine contact status or tissue proximity, as well as to detect a faulty electrode or a faulty circuit in the plurality of electrodes.
A prosthetic heart valve includes a collapsible and expandable stent extending along a longitudinal axis and having an inflow end and an outflow end, the stent including a plurality of cells annularly arranged around the stent in at least one row, the plurality of cells having a first nesting cell adjacent the outflow end of the stent, a first engaging arm disposed within the first nesting cell and being pivotally movable between a loaded condition, a partially-released condition, and a fully-released condition, the first engaging arm and the first nesting cell having a synchronous pivoting movement, and a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets.
The present invention provides an improved vascular occlusion device having improved flexibility and retention of the type fabricated from braided tubular metal fabric having an expanded preset configuration and an elongated collapsed reduced diameter configuration for delivery through a catheter to a treatment site and shaped to create an occlusion of an abnormal opening in a body organ or vessel, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained. The device further including at least one disk portion adjacent a body cylindrical portion formed from the fabric and having a transition diameter between the disk and cylindrical portion, significantly smaller than the diameter of the disk and the diameter of the cylindrical portion.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
35.
SYSTEM, METHOD, AND APPARATUS FOR VISUALIZING CARDIAC TIMING INFORMATION USING ANIMATIONS
An animated electrophysiology map is generated from a plurality of data points, each including measured electrophysiology information, location information, and timing information. The electrophysiology and location information can be used to generate the electrophysiology map, such as a local activation time, peak-to-peak voltage, or fractionation map. Animated timing markers can be superimposed upon the electrophysiology map using the electrophysiology, location, and timing information. For example a series of frames can be displayed sequentially, each including a static image of the electrophysiology map at a point in time and timing markers corresponding to the state or position of an activation wavefront at the point in time superimposed thereon. The visibility or opacity of the timing markers can be adjusted from frame to frame, dependent upon a distance between the timing marker and the activation wavefront, to give the illusion that the timing markers are moving along the electrophysiology map.
A method of determining contact status of electrodes includes applying drive signals between pairs of electrodes, measuring a bipolar electrode complex impedance (BECI) value generated in response to the drive signals over a collection period, and determining a baseline BECI value representing a minimum value measured during the collection period. The method further includes determining contact status of the electrode by applying drive signals between pairs of electrodes over a given interval, measuring a BECI value generated in response to the drive signals, measuring a peak-to-peak value associated with the BECI values measured over the given interval, and determining contact status based on a combination of the baseline BECI value, the measured BECI value, and the peak-to-peak value associated with the measured BECI values.
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A61B 5/053 - Measuring electrical impedance or conductance of a portion of the body
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A prosthetic heart valve includes a collapsible and expandable stent having an inflow end and an outflow end, and a plurality of struts defining a plurality of cells, the stent being formed of a first material, a plurality of commissure attachment features formed of a second material that is different than the first material of the stent, and a collapsible and expandable valve assembly including a plurality of leaflets connected to the plurality of commissure attachment features.
A prosthetic heart valve includes a collapsible and expandable stent having an inflow end and an outflow end, and a plurality of struts defining a plurality of cells, the stent being formed of a first material, a plurality of commissure attachment features formed of a second material that is different than the first material of the stent, and a collapsible and expandable valve assembly including a plurality of leaflets connected to the plurality of commissure attachment features.
A catheter assembly is provided. The catheter assembly includes a catheter including at least one lesion generating electrode, the at least one lesion generating electrode configured to be positioned within a patient, and at least one return array configured to be positioned within the patient and remote from the at least one lesion generating electrode, the at least one return array including at least one return electrode, wherein the catheter assembly is configured to apply energy between i) the at least one lesion generating electrode and ii) a return patch and the at least one return electrode to generate lesions proximate the at least one lesion generating electrode.
A61B 18/16 - Indifferent or passive electrodes for grounding
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A catheter assembly is provided. The catheter assembly includes a catheter including at least one lesion generating electrode, the at least one lesion generating electrode configured to be positioned within a patient, and at least one return array configured to be positioned within the patient and remote from the at least one lesion generating electrode, the at least one return array including at least one return electrode, wherein the catheter assembly is configured to apply energy between i) the at least one lesion generating electrode and ii) a return patch and the at least one return electrode to generate lesions proximate the at least one lesion generating electrode.
A61B 18/16 - Indifferent or passive electrodes for grounding
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
In some examples, a delivery device includes a handle, a catheter sheath defining a lumen and extending distally from the handle, and a hemostasis valve positioned at least partially within the handle, the hemostasis valve being located proximal the catheter sheath, the hemostasis valve including a first seal and a second seal, and a first flush-port disposed between the first seal and the second seal.
Disclosed herein is an ablation catheter that includes an irrigation conduit, a force sensor, a flexible electrode tip assembly, a seal, and a temperature sensor. The irrigation conduit defines an irrigation lumen configured to carry irrigation fluid to a distal end of the ablation catheter. The force sensor includes a deformable body coupled to the irrigation conduit adjacent a distal end thereof. The flexible electrode tip assembly is coupled to the deformable body and extends distally therefrom, and defines an interior cavity in fluid communication with the irrigation lumen, an exterior cavity in which a distal portion of the deformable body is received, and at least one fluid channel through which irrigation fluid is dispensed from the interior cavity. The seal is disposed between the flexible electrode tip assembly and the deformable body, and the temperature sensor extends through the irrigation lumen and into the flexible electrode tip assembly.
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
Embodiments of the present invention provide an improved vascular occlusion device for occlusion of a passageway, cavity, or the like. According to one embodiment, a medical device for occluding a left atrial appendage is provided. The medical device includes a first portion having at least one plane of occlusion that is configured to be positioned outside of the left atrial appendage, and a second portion having at least one plane of occlusion that is configured to be at least partially positioned within a cavity defined by the left atrial appendage.
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
A61B 17/00 - Surgical instruments, devices or methods
44.
DEVICES AND METHODS FOR OCCLUDING ABNORMAL OPENINGS IN A PATIENT'S VASCULATURE
A medical device is provided in which one or both ends of the device encourage the formation of tissue across substantially the entire area of the respective end that is exposed to the blood flow for reducing the risk of a thrombotic embolism. The medical device includes a tubular structure having at least one expanded volume portion and a tapered transition portion. The tubular structure may be made through the braiding of a number of strands, and a first end feature may be used to secure the proximal strand ends. The proximal strand ends may be secured via the proximal end of the first end feature, such that the tapered transition portion is formed over the circumferential surface of the first end feature, and only a proximal end surface (or a portion of the proximal end surface) of the first end feature is exposed to the path of flowing blood.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
45.
SYSTEM AND METHOD FOR ASSESSING CONDUCTION BLOCK IN TISSUE
Conduction block across a lesion in tissue can be assessed by applying a pacing signal to tissue on one side of the lesion and sensing electrophysiological activity in the tissue on the opposite side of the lesion. A signal processor, such as may be incorporated into an electroanatomical mapping system, analyzes the sensed electrophysiological activity for a response evoked by the pacing signal and outputs an indicator of conduction block status. More particularly, when a preset number of consecutive pacing pulses do not yield an evoked response, an indicator of block can be output; conversely, when a preset number of consecutive pacing pulses do yield an evoked response, an indicator of no block can be output.
A deflectable catheter is disclosed. The deflectable catheter includes a deflectable shaft including a proximal portion and a distal portion, the distal portion of the deflectable shaft including one or more electrodes. The deflectable catheter also includes a pull ring disposed in the distal portion of the deflectable shaft, a first pull wire, and a second pull wire. Both the first pull wire and the second pull wire extend through the proximal portion of the deflectable shaft and a distal end of the first pull wire and a distal end of the second pull wire are coupled to the pull ring. The deflectable catheter also includes a cylindrical braid structure at least partially disposed within the distal portion of the deflectable shaft.
A61B 17/00 - Surgical instruments, devices or methods
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/02 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
A61B 18/20 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
A prosthetic heart valve for replacing a native valve includes a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition. At least one runner is coupled a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.
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
48.
GUIDANCE FOR NAVIGATION AND POSITIONING OF INTRAVASCULARLY DELIVERED DEVICES
Techniques are provided for guidance for navigation and positioning of intravascularly delivered devices. A medical navigation system includes a delivery device comprising a catheter, an intravascularly delivered device configured to be releasably disposed in the catheter for deployment at a target site of a patient, and a navigation computer system. The intravascularly delivered device includes a plurality of electrodes including at least one indicator electrode and at least one reference electrode configured to not contact tissue when the intravascularly delivered device is deployed at the target site. The navigation computer system is configured to be electrically coupled with the plurality of electrodes. The navigation computer system controls a drive source to transmit current to the plurality of electrodes, collects electrode data corresponding to the plurality of electrodes, monitors impedance corresponding to the indicator electrode, and determines that the indicator electrode has made contact with tissue.
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
A61B 34/10 - Computer-aided planning, simulation or modelling of surgical operations
49.
GUIDANCE FOR NAVIGATION AND POSITIONING OF INTRAVASCULARLY DELIVERED DEVICES
Techniques are provided for guidance for navigation and positioning of intravascularly delivered devices. A medical navigation system includes a delivery device comprising a catheter, an intravascularly delivered device configured to be releasably disposed in the catheter for deployment at a target site of a patient, and a navigation computer system. The intravascularly delivered device includes a plurality of electrodes including at least one indicator electrode and at least one reference electrode configured to not contact tissue when the intravascularly delivered device is deployed at the target site. The navigation computer system is configured to be electrically coupled with the plurality of electrodes. The navigation computer system controls a drive source to transmit current to the plurality of electrodes, collects electrode data corresponding to the plurality of electrodes, monitors impedance corresponding to the indicator electrode, and determines that the indicator electrode has made contact with tissue.
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
The present invention generally relates to expandable catheters for use in electrophysiology, and more specifically to high-density balloon catheters for use in diagnosing and/or treating cardiac arrhythmias. A catheter includes an elongate catheter shaft comprising a proximal end and a distal end. The elongate catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second deployed configuration. The balloon member includes at least one flexible framework disposed between an outer facing layer and an inner facing layer of the top surface and/or the bottom surface of the balloon member and at least one plurality of electrodes patterned onto the flexible framework. In some embodiments, a flat balloon member includes electrodes on both sides of the planar balloon member. The balloon member may include a flexible structural element disposed within the interior cavity.
Systems and methods for automatic detection of phrenic nerve stimulation are disclosed. A plurality of pacing pulses are delivered between an associated pair of electrodes of a plurality of electrodes. For each of the plurality of pacing pulses, a corresponding diaphragm movement during delivery of the pacing pulse is measured. For each of the plurality of pacing pulses, it is determined, based on the corresponding measured diaphragm movement, whether the pacing pulse results in phrenic nerve capture. For each pacing pulse that results in phrenic nerve capture, the pair of electrodes associated with that pacing pulse is recorded.
P00 P00 P11 P00 P22 x, y, zP11 P22 2 is computed. The method includes generating an output indicative of detected deliberate motion based on the computed running variance.
Systems and methods for automatic detection of phrenic nerve stimulation are disclosed. A plurality of pacing pulses are delivered between an associated pair of electrodes of a plurality of electrodes. For each of the plurality of pacing pulses, a corresponding diaphragm movement during delivery of the pacing pulse is measured. For each of the plurality of pacing pulses, it is determined, based on the corresponding measured diaphragm movement, whether the pacing pulse results in phrenic nerve capture. For each pacing pulse that results in phrenic nerve capture, the pair of electrodes associated with that pacing pulse is recorded.
According to some embodiments of the present disclosure, a method for detecting deliberate motion of a catheter positioned within a patient and including a magnetic sensor includes collecting a plurality of first magnetic sensor samples. The method includes measuring a sensor position P0 in 3D coordinates for each of the first magnetic sensor samples and measuring a sensor orientation for each of the first magnetic sensor samples. Measuring the sensor orientation includes generating a first vector (P0-P1) and generating a second vector (P0-P2) orthogonal to the first vector. The method includes removing a respiration motion frequency component from the from the plurality of first magnetic sensor samples with a signal processing filter. A running variance for each axis (x, y, z) of the P1 and P2 is computed. The method includes generating an output indicative of detected deliberate motion based on the computed running variance.
Medical devices and systems including electrical traces are provided. The medical device includes a sheath body including an inner wall, an outer wall, and a central major lumen extending through the sheath body along a longitudinal axis. The central major lumen is defined by the inner wall. The medical device further includes at least one outer lumen extending through said sheath body, wherein the at least one outer lumen is disposed between the inner wall and the outer wall, at least one electrode coupled to a distal portion of said sheath body, and at least one electrical trace. Each of the at least one electrodes is coupled to at least one electrical trace, and the electrical trace is disposed between the inner wall and the outer wall.
Systems and methods for electroporation catheters are provided herein. An electroporation catheter includes a shaft, and a variable diameter loop coupled to a distal end of the shaft, the variable diameter loop including a plurality of electrodes. The catheter further includes a plurality of electrical wires connected to the plurality of electrodes and extending through the variable diameter loop and the shaft, the plurality of electrical wires configured to energize the plurality of electrodes, and a multi-lumen arrangement extending through at least a portion of at least one of the shaft and the variable diameter loop. The multi-lumen arrangement includes a first lumen housing a first subset of the plurality of electrical wires, and a second lumen housing a second subset of the plurality of electrical wires.
A deflectable catheter assembly (100) including a handle (200), a catheter shaft (120). The catheter further includes one or more pull wires (217) to effect a deflection. The handle includes a housing (201a), (201b), a deflection control coupled to the housing and operable to deflect the deflectable shaft section, and a deflection feedback assembly (e.g., a variable resistor) disposed within the housing. The deflection feedback assembly is coupled to the deflection control and configured to convert motion of the deflection control into a signal indicative of a degree of deflection of the deflectable shaft section. The deflection feedback assembly provides an active feedback regarding deflection of the deflectable shaft section to facilitate accurate positioning of the deflectable shaft section within a patient.
The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
59.
System and Method for Generating Three Dimensional Geometric Models of Anatomical Regions
A three-dimensional geometric model of a heart can be generated from a plurality of two-dimensional image slices of the heart collected using an intracardiac echocardiography (“ICE”) catheter. Each image slice can be associated with localization information for the ICE catheter. The image slices can be output in a plurality of voxels according to their associated localization information, thereby creating a three-dimensional geometric model of the heart. Data sufficiency of the three-dimensional model can also be graphically represented. For example, data sufficiency can be represented using voxel opacity, a one-dimensional illustration, a two-dimensional illustration, and/or a data collection cue.
A flexible electronic circuit includes a plurality of leaves having a proximal section, a distal section, and an intermediate section. The plurality of leaves are bonded to each other within the distal section and loose within the intermediate section. The intermediate section also includes conductive connector pads for a wiring harness. A plurality of test connector pads are disposed on the plurality of leaves within the proximal section. The leaves within the proximal section may also be bonded to each other, for example in a ribbon or stepped configuration, in order to facilitate connection to testing apparatus. Once the circuit is tested, the proximal section can be severed from the intermediate section prior to installation of the circuit into a medical device, such as an intracardiac echocardiography catheter.
A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The heart valve further includes a plurality of commissure features disposed on the stent, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features, each of the plurality of leaflets having a free edge and being configured to have a tension line aligned near the free edge to prevent backflow.
A method of determining a baseline impedance value for a first electrode in a plurality of electrodes located on a medical device for tissue contact detection includes measuring an impedance value of the first electrode generated in response to a drive signal to the first electrode. The method further includes assigning a baseline impedance value to the first electrode based on impedance values measured in a predetermined time interval and determining a confidence value associated with the baseline impedance value. The method further includes utilizing the baseline impedance value in determining contact status of the first electrode when the confidence value is at or above a predetermined threshold value.
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A61B 5/053 - Measuring electrical impedance or conductance of a portion of the body
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A method of assembling a prosthetic heart valve includes providing a collapsible and expandable stent having an annulus section and an aortic section. The annulus section has a first diameter in a relaxed condition and a second diameter less than the first diameter in a collapsed condition. A constraint is applied to the stent to constrain the annulus section to a predetermined diameter between the first and second diameters. Applying a cuff and/or a plurality of leaflets to the stent in the constrained condition enables less material to be used. The resultant prosthetic valve is therefore able to be collapsed to a smaller diameter for introduction into a patient.
A61F 2/90 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
A61F 2/95 - Instruments specially adapted for placement or removal of stents or stent-grafts
64.
Flexible High-Density Mapping Catheter Tips and Flexible Ablation Catheter Tips With Onboard High-Density Mapping Electrodes
Flexible high-density mapping catheter tips and flexible ablation catheter tips with onboard high-density mapping electrodes are disclosed. These tips can be used for diagnosing and treating cardiac arrhythmias. The flexible, distal tips are adapted to conform to tissue and comprise a plurality of microelectrodes mounted to permit relative movement among at least some of the microelectrodes. The flexible tip portions may comprise a flexible framework forming a flexible array of microelectrodes (for example, a planar or cylindrical array) adapted to conform to tissue and constructed at least in part from nonconductive material in some embodiments. The flexible array of microelectrodes may be formed from a plurality of rows of longitudinally-aligned microelectrodes. The flexible array may further comprise, for example, a plurality of electrode-carrying arms or electrode-carrier bands. Multiple flexible frameworks may be present on a single device. A delivery adapter having an internal compression cone is also disclosed.
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A gasket for a hemostasis valve includes an annular wall, a membrane, a central protrusion on the membrane, and a plurality of ligaments attached to the central protrusion extending radially to the annular wall. The membrane, central protrusion, and ligaments are divided by slits into a plurality of flaps, with each flap bounded along an outer circumferential edge by the annular wall, along an inner circumferential edge by the central protrusion, and along its radial edges by segments of the ligaments. Two such gaskets can be arranged, back-toback, in a hemostasis valve. To facilitate such assembly, each gasket can include a plurality of positioning protrusions extending axially and a plurality of positioning recesses set into a circumferential surface, with the protrusions and recesses having complementary shapes for proper interconnection and fit between gaskets.
A method of modifying contact status of one or more electrodes in a plurality of electrodes located on a medical device includes measuring an electrical characteristic of each electrode in the plurality of electrodes located on the medical device, determining a contact status for each electrode in the plurality of electrodes based on the measured electrical characteristic for the corresponding electrode, wherein the contact status is indicative of contact with adjacent tissue. The method further includes modifying the contact status of a first electrode in the plurality of electrodes based on the determined contact status of one or more other electrodes in the plurality of electrodes.
The present disclosure provides electroporation catheters that are capable of forming a loop, generally a circular loop, an oval loop, or like in shape, located on the distal end portion of a catheter shaft within the vasculature of an individual. The electroporation catheters of the present disclosure may be delivered into the vasculature of the individual in a straight conformation and allow for the formation of the loop once positioned in the desired location. Some embodiments of the present disclosure include an electroporation catheter that includes a loop member pull wire in a spiral or helical configuration on an inside surface of the distal end portion of the catheter shaft.
A prosthetic heart valve for replacing a native atrioventricular valve may include a collapsible and expandable frame including an atrial disk, a ventricular disk, and a center portion extending between the atrial disk and the ventricular disk. A plurality of prosthetic leaflets may be mounted inside the frame, and an outer fabric may be coupled to the frame, the outer fabric extending from the atrial disk to the ventricular disk. One or more members may each have opposite ends coupled to the atrial and ventricular disk, and a center portion that is not coupled to the central portion of the frame. The one or more members may be positioned radially inward of the outer fabric. As the frame expands from a collapsed condition to an expanded condition, the one or more members urge the outer fabric radially outwardly relative to a central longitudinal axis of the frame.
Devices and techniques that enable multiple electrodes to be positioned proximate organic tissue, such as human tissue. In one embodiment, a catheter is provided that includes a shaft and a distal segment. The distal segment includes a plurality of electrodes configured in a plane that is substantially parallel with the longitudinal axis of the shaft.
A61B 17/00 - Surgical instruments, devices or methods
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/20 - Applying electric currents by contact electrodes continuous direct currents
71.
Active and Passive Cuff Management Devices for Loading of Transcatheter Valves
A cuff management device for use when loading a prosthetic heart valve includes a body extending between a first end and a second end, a plurality of legs disposed at the first end, and one or more segments disposed at the second end, the one or more segments having one or more protrusion on an interior surface thereof.
A61F 2/95 - Instruments specially adapted for placement or removal of stents or stent-grafts
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
An apparatus for transseptal catheterization includes a dilator with an energy delivery element attached to its distal end. The energy delivery element is configured to deliver sufficient energy to a tissue, such as the fossa ovalis, adjacent the distal end to permit the dilator to penetrate the tissue and cross into the left atrium. The energy delivery element can be a radiofrequency electrode, a pulsed field ablation electrode, an ultrasound transducer, or the like. A guidewire and/or introducer may also be included to facilitate the transseptal catheterization.
A method for determining a predicted lesion size formed in a tissue by receiving or calculating a measure of contact force between the electrode and the tissue, determining a tissue characterization, and calculating the predicted lesion size using both the measure of contact force and the tissue characterization. A system comprising an electronic control unit configured to receive or determine a measure of contact force between the electrode and the tissue, characterize the tissue based on both the measure of impedance and the measure of contact force, and cause the tissue characterization to be either (a) presented to a user, or (b) applied to calculate a metric and cause the metric to be presented to the user.
A61B 34/10 - Computer-aided planning, simulation or modelling of surgical operations
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A61B 34/00 - Computer-aided surgeryManipulators or robots specially adapted for use in surgery
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
74.
APPARATUS AND METHODS FOR TRANSSEPTAL CATHETERIZATION
An apparatus for transseptal catheterization includes a dilator with an energy delivery element attached to its distal end. The energy delivery element is configured to deliver sufficient energy to a tissue, such as the fossa ovalis, adjacent the distal end to permit the dilator to penetrate the tissue and cross into the left atrium. The energy delivery element can be a radiofrequency electrode, a pulsed field ablation electrode, an ultrasound transducer, or the like. A guidewire and/or introducer may also be included to facilitate the transseptal catheterization.
A delivery device for a collapsible prosthetic heart valve, the delivery device including an inner shaft, a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment being adapted to receive the prosthetic heart valve, the inner shaft and the distal sheath being movable relative to one another, and a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle further including a deployment actuator and a hub, each of the deployment actuator and the hub being independently capable of opening and closing the compartment, the hub further including a hub actuator coupled to the inner shaft.
A prosthetic heart valve includes an outer frame, an outer sealing skirt, an inner frame, an inner sealing skirt, a plurality of prosthetic leaflets mounted within the inner frame, and a plurality of connecting arms connecting the inner frame to the outer frame so that the inner frame is positioned radially inward of the outer frame. A bridging skirt extends from the outer sealing skirt to an inflow edge of the inner sealing skirt. The bridging skirt covers a gap between the inner frame and the outer frame. The inner sealing skirt may include at least one trench that interrupts an otherwise circular shape of the inflow edge of the inner sealing skirt, the trench extending in an outflow direction of the prosthetic heart valve.
A prosthetic atrioventricular valve may include a collapsible frame including an atrial disk, a ventricular disk, and a center portion between the two. The frame may include commissure attachment features ("CAFs") that include struts extending from the center portion. Prosthetic leaflets may be mounted to the CAFs. A sealing fabric may be coupled to the frame. A commissure support ring may couple to and extend around the plurality of CAFs. The atrial disk and the ventricular disk may each flare outwardly from the center portion of the frame. The center portion of the frame may define a minimum diameter of the frame. Each of the CAFs may be spaced from adjacent ones of the CAFs so that gaps in the frame are present between adjacent ones of the CAFs.
In some embodiments, a medical instrument includes a flexible sheath configured to pass through the femoral artery, an inner catheter at least partially disposed within the sheath and rotatable relative thereto, the inner catheter has a deflectable section, a pair of opposing jaws coupled to the inner catheter, the pair of opposing jaws having an open condition and a closed condition, and a cutting mechanism disposed adjacent to at least one of the pair of opposing jaws.
A prosthetic heart valve includes an outer frame, an outer sealing skirt, an inner frame, an inner sealing skirt, a plurality of prosthetic leaflets mounted within the inner frame, and a plurality of connecting arms connecting the inner frame to the outer frame so that the inner frame is positioned radially inward of the outer frame. A bridging skirt extends from the outer sealing skirt to an inflow edge of the inner sealing skirt. The bridging skirt covers a gap between the inner frame and the outer frame. The inner sealing skirt may include at least one trench that interrupts an otherwise circular shape of the inflow edge of the inner sealing skirt, the trench extending in an outflow direction of the prosthetic heart valve.
A prosthetic heart valve for replacing a native atrioventricular valve includes a collapsible and expandable frame having atrial and ventricular portions each including a circumferential row of cells, and a center portion extending between the atrial and ventricular portion. The atrial portion and the ventricular portion may flare radially outwardly from the center portion in an expanded condition of the frame. A plurality of prosthetic leaflets may be mounted to the frame. At least some of the struts forming the cells in the atrial portion include an undulating structure positioned between two axially extending strut portions, the undulating structure including at least one circumferentially extending strut portion and being configured to dampen forces transmitted across the undulating structure between the two axially extending strut portions
A61F 2/915 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
81.
Transcatheter Prosthetic Atrioventricular Valve with Hinged Stent
A prosthetic heart valve for replacing a native atrioventricular valve includes a collapsible and expandable frame having atrial and ventricular portions each including a circumferential row of cells, and a center portion extending between the atrial and ventricular portion. The atrial portion and the ventricular portion may flare radially outwardly from the center portion in an expanded condition of the frame. A plurality of prosthetic leaflets may be mounted to the frame. At least some of the struts forming the cells in the atrial portion include an undulating structure positioned between two axially extending strut portions, the undulating structure including at least one circumferentially extending strut portion and being configured to dampen forces transmitted across the undulating structure between the two axially extending strut portions
A medical device manufacturing process can include inserting a hollow shaft having a longitudinally-extending slit into the central lumen of a tubular device body, leaving its distal end protruding beyond the device body. The shaft includes an inner layer of a first material and an outer layer of a second material; the second material melts at a lower temperature than the first material. A sensor stack (14), including alternately-disposed spacing elements (14) and sensors (28), is formed around the protruding segment of the shaft. The spacing elements include an inner layer (34a) of a third material and an outer layer (34b) of a fourth material; the third material melts at a lower temperature than the fourth material. The assembly bonded by heating it above the melting temperatures of the second and third materials but below the those of the first and fourth materials.
A flexible electronic circuit, as may be used in an intravascular catheter, includes a flexible substrate having opposing first and second surfaces, one or more recesses into the first surface, one or more localization elements respectively disposed within the recesses, and a conductive connector pad on the substrate. Additional components, such as thermistors and ultrasound transducers, may also be mounted to the substrate.
A catheter assembly is provided. The catheter assembly includes a tip electrode array including at least one tip electrode, the tip electrode array located at a distal end of the catheter assembly, and a mini electrode array including a plurality of mini electrodes, the mini electrode array positioned proximal of the tip electrode array, wherein each of the at least one tip electrode and each of the plurality of mini electrodes are configured to be activated independent of one another for mapping applications, and wherein at least some of the at least one tip electrode and the plurality of mini electrodes are configured to be activated in unison for ablation applications.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/287 - Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
A61B 5/367 - Electrophysiological study [EPS], e.g. electrical activation mapping or electro-anatomical mapping
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
85.
Transcatheter Prosthetic Atrioventricular Valve with Stiffening Structure
A prosthetic atrioventricular valve may include a collapsible frame including an atrial disk, a ventricular disk, and a center portion between the two. The frame may include commissure attachment features (“CAFs”) that include struts extending from the center portion. Prosthetic leaflets may be mounted to the CAFs. A sealing fabric may be coupled to the frame. A commissure support ring may couple to and extend around the plurality of CAFs. The atrial disk and the ventricular disk may each flare outwardly from the center portion of the frame. The center portion of the frame may define a minimum diameter of the frame. Each of the CAFs may be spaced from adjacent ones of the CAFs so that gaps in the frame are present between adjacent ones of the CAFs.
A catheter assembly is provided. The catheter assembly includes a tip electrode array including at least one tip electrode, the tip electrode array located at a distal end of the catheter assembly, and a mini electrode array including a plurality of mini electrodes, the mini electrode array positioned proximal of the tip electrode array, wherein each of the at least one tip electrode and each of the plurality of mini electrodes are configured to be activated independent of one another for mapping applications, and wherein at least some of the at least one tip electrode and the plurality of mini electrodes are configured to be activated in unison for ablation applications.
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A61B 18/16 - Indifferent or passive electrodes for grounding
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
87.
Delivery System for Self-Expanding Valve with Exposed Cuff
A prosthetic heart valve includes a self-expanding frame, a valve assembly, and an outer cuff. A delivery device includes an inner shaft, an outer shaft, and a distal sheath disposed about a portion of the inner shaft to form a compartment with the inner shaft. The inner shaft and the distal sheath may be axially translatable relative to one another. A distal tip may be disposed at a distal end of the delivery device. In a delivery condition of the system, the distal sheath may be in a distal-most position in which the distal sheath overlies portions of the prosthetic heart valve but a distal end of the distal sheath leaves the outer cuff uncovered. In the delivery condition, a gap distance may exist between the distal end of the distal sheath and a proximal end of the distal tip, the outer cuff being positioned along the gap distance.
A delivery device includes a catheter, and an inflatable balloon coupled to the catheter, the inflatable balloon forming a leading pillow and a trailing pillow spaced from the leading pillow, the leading pillow and the trailing pillow defining a valve seat therebetween to retain a prosthetic heart valve during tracking of the delivery device.
A prosthetic heart may include an expandable frame and prosthetic leaflets that each have a free edge, an attached edge having a contour, a first flat surface facing toward the frame, and a second flat surface facing away from the frame. A spacer fabric may be attached to each leaflet, the spacer fabric having a first surface, a second surface, and an inner matrix between the first and second surfaces. Each spacer fabric may follow the contour of the attached edge of a corresponding one of the prosthetic leaflets, and each spacer fabric may be wrapped around the contour of the attached edge of the corresponding one of the prosthetic leaflets such that the first surface of each spacer fabric contacts the first flat surface and the second flat surface of the corresponding prosthetic leaflet, each prosthetic leaflet being coupled to the frame via the corresponding spacer fabric.
A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.
A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.
A delivery device includes a catheter, and an inflatable balloon coupled to the catheter, the inflatable balloon forming a leading pillow and a trailing pillow spaced from the leading pillow, the leading pillow and the trailing pillow defining a valve seat therebetween to retain a prosthetic heart valve during tracking of the delivery device.
A prosthetic heart may include an expandable frame and prosthetic leaflets that each have a free edge, an attached edge having a contour, a first flat surface facing toward the frame, and a second flat surface facing away from the frame. A spacer fabric may be attached to each leaflet, the spacer fabric having a first surface, a second surface, and an inner matrix between the first and second surfaces. Each spacer fabric may follow the contour of the attached edge of a corresponding one of the prosthetic leaflets, and each spacer fabric may be wrapped around the contour of the attached edge of the corresponding one of the prosthetic leaflets such that the first surface of each spacer fabric contacts the first flat surface and the second flat surface of the corresponding prosthetic leaflet, each prosthetic leaflet being coupled to the frame via the corresponding spacer fabric
A catheter includes a shaft including a proximal end and a distal end, an electrical conductor coupled to the catheter, and an electrode coupled to the electrical conductor. The electrode includes at least one recessed portion, and an impedance reduction layer disposed in the at least one recessed portion. The impedance reduction layer has a thickness less than a depth of the recessed portion.
A method of modifying contact status of one or more electrodes in a plurality of electrodes located on a medical device includes measuring an electrical characteristic of each electrode in the plurality of electrodes located on the medical device, determining a contact status for each electrode in the plurality of electrodes based on the measured electrical characteristic for the corresponding electrode, wherein the contact status is indicative of contact with adjacent tissue. The method further includes modifying the contact status of a first electrode in the plurality of electrodes based on the determined contact status of one or more other electrodes in the plurality of electrodes.
Catheter shaft assemblies that include a rubber member and a ring electrode mounted to induce radial deformation of the rubber member to inhibit loss of interference fit of the ring electrode, and related methods of fabrication, are disclosed. A catheter shaft assembly includes an elongate tubular inner layer, a first rubber member, an elongate outer layer, and one or more ring electrodes. The first rubber member is disposed on an exterior surface of the elongate tubular inner layer. The elongate outer layer covers an exterior surface of the first rubber member or the elongate tubular inner layer. The one or more ring electrodes are attached to and encircle the elongate outer layer or the first rubber member. Each of the ring electrodes induces a radial hyperelastic deformation of the first rubber member that inhibits loss of an interference fit of the ring electrode.
Pulse generating circuitry configured to be coupled to a plurality of electrodes of an electroporation system is described. The pulse generating circuitry includes at least one voltage source, a plurality of output lines, switching circuitry coupled between the at least one voltage source and the plurality of output lines, each of the plurality of output lines configured to deliver at least one voltage pulse to a corresponding electrode of the plurality of electrodes, and current sensing circuitry configured to sense a current flowing through at least one of the plurality of output lines.
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
In some embodiments, a prosthetic heart valve system, includes a stent having a plurality of commissure attachment features, a cuff coupled to the stent, a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and a plurality of patches, each of the plurality of patches being disposed about a selected one of the plurality of commissure attachment features and coupled thereto, the plurality of leaflets being coupled to plurality of patches.
A pull wire assembly for a steerable medical device can include wire lock and a wire. The wire lock includes a spool body having first and ends and first and second rims respectively around the first and second ends. A through-hole extends diametrically through the spool body. The wire enters through a distal end of the through-hole, emerges through a proximal end of the through-hole, wraps around an exterior of the spool body, re-enters into the distal end of the through-hole, and re-emerges through the proximal end of the through-hole. The wire may make multiple such passes. The wire may also be tensioned to at least partially embed into the surface of the spool body.
A pull wire assembly for a steerable medical device can include wire lock and a wire. The wire lock includes a spool body having first and ends and first and second rims respectively around the first and second ends. A through-hole extends diametrically through the spool body. The wire enters through a distal end of the through-hole, emerges through a proximal end of the through-hole, wraps around an exterior of the spool body, re-enters into the distal end of the through-hole, and re-emerges through the proximal end of the through-hole. The wire may make multiple such passes. The wire may also be tensioned to at least partially embed into the surface of the spool body.
