A delivery apparatus can include one or more actuator assemblies extending from a handle. Each actuator assembly can include an outer sleeve and an actuation member extending having an engagement portion configured to releasably couple an actuator of a prosthetic heart valve. The engagement portion can include a driver head comprising an engagement element configured to engage a corresponding engagement element in a head portion of the actuator, and a gripper member comprising a plurality of arms configured to releasably couple the head portion of the actuator. Each arm can have a distal end portion having a circumferential width wider than a circumferential width of a proximal end portion and an arcuate sectional shape. Rotation of the actuation member in a first direction can radially expands the prosthetic heart valve and rotation of the actuation member in a second direction can radially compress the prosthetic heart valve.
Devices and methods for providing a reservoir of fluid within a handle of a guide catheter are disclosed. As one example, a delivery apparatus can include a handle including a proximal segment including one or more fluid seals mounted within the proximal segment, an intermediate segment disposed adjacent and distal to the proximal segment, the intermediate segment including an inner surface defining a first lumen having a first inner diameter, and a distal segment disposed adjacent and distal to the intermediate segment. The delivery apparatus can further include a shaft extending distally from the handle, the shaft including a second lumen extending between a distal end and a proximal end of the shaft, the second lumen including a second inner diameter that is smaller than the first inner diameter of the first lumen.
Disclosed herein are reinforced expandable introducer sheaths and methods of using the same. The sheaths minimize trauma to the patient's vasculature by including a reinforcing member to improve the push force of the sheath while reducing the chances of kinking during delivery of a prosthetic device. The sheath can include a plurality of expandable rings aligned along the longitudinal axis of the sheath and coupled together to form an elongated tubular structure. The sheath can also include a plurality of radial members circumferentially arranged to form a tubular support structure. The radial members slidingly interconnected around the circumference of the tubular structure to facilitate radial expansion of the sheath.
A61F 2/962 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes possédant une gaine extérieure
4.
PROSTHETIC VALVES WITH VALVULAR STRUCTURES RETAINED BETWEEN TWO FRAMES
The present disclosure relates to prosthetic valves that include valvular structures retained between two frames coupled to each other. In an example, the prosthetic valve includes a main frame, an inner frame which is disposed radially inwardly from, and is coupled to, the main frame, and a valvular structure disposed between the main frame and the inner frame. The main frame is movable between a radially compressed state and a radially expanded state. The inner frame comprises a plurality of struts and a plurality of spikes extending from at least some of the plurality of struts. The plurality of spikes are engaged with the valvular structure.
A61F 2/00 - Filtres implantables dans les vaisseaux sanguins; Prothèses, c.-à-d. éléments de substitution ou de remplacement pour des parties du corps; Appareils pour les assujettir au corps; Dispositifs maintenant le passage ou évitant l'affaissement de structures corporelles tubulaires, p.ex. stents
A61F 2/852 - Dispositifs maintenant le passage ou évitant l’affaissement de structures tubulaires du corps, p.ex. stents constitués d’au moins deux stents distincts se chevauchant
5.
DEVICES AND METHODS FOR FORMING PROSTHETIC VALVE LEAFLETS
A packaging assembly for storing a prosthetic heart valve can comprise a valve tray comprising an annular rim and a cavity extending away from the annular rim, wherein the cavity is configured to accept the prosthetic heart valve. The packaging assembly can further comprise a lid configured to cover the annular rim. The packaging assembly can further comprise a leaflet biasing element disposed on a central portion of the lid. The leaflet biasing element can comprise an extrusion with a paraboloid shape that can extend from a lower surface of the lid towards the valve tray. The leaflet biasing element can be configured to extend at least partially into an inflow end portion of the prosthetic heart valve and secure a plurality of leaflets of the prosthetic heart valve in a desired configuration when the prosthetic heart valve is inserted in the cavity and the lid is closed over the annular rim.
A61F 2/00 - Filtres implantables dans les vaisseaux sanguins; Prothèses, c.-à-d. éléments de substitution ou de remplacement pour des parties du corps; Appareils pour les assujettir au corps; Dispositifs maintenant le passage ou évitant l'affaissement de structures corporelles tubulaires, p.ex. stents
6.
TRANSCATHETER PROSTHETIC HEART VALVE AND DELIVERY SYSTEM
A prosthetic heart valve for transcatheter delivery that includes a collapsible and expandable inner stent, a plurality of valve leaflets supported within the inner stent, a collapsible and expandable outer frame having a lower radial strength than the inner stent for conforming to a shape of a native heart valve, a sealing material attached to the outer frame, and a plurality of anchors extending radially outwardly of the outer frame. The inner stent includes an atrial end and a ventricular end. The outer frame surrounds at least a portion of the atrial end of the inner stent and extends towards the ventricular end of the inner stent. The outer frame includes an atrial end having a larger dimension than that of the ventricular end of the inner stent.
Disclosed herein are embodiments of a balloon shaped to have one or more enlarged regions to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve's tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon—reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.
A61F 2/958 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes ballons gonflables pour insérer les stents ou les endoprothèses déployables couvertes
A steerable catheter device can include a shaft having a proximal portion and a distal portion. The steerable catheter device can further include a pull wire extending through the proximal portion of the shaft and the distal portion of the shaft. Tension applied to the pull wire is effective to flex the proximal portion in a first direction and flex the distal portion in a second direction different than the first direction.
Improved features of medical devices. Implants that may include self-expanding portions and portions that are expandable with an inflatable body. A portion expandable with an inflatable body may dock with a portion that is self-expanding. A portion expandable with an inflatable body may be coupled to a portion that is self-expanding. Delivery apparatuses for deployment of both a self-expanding portion and a portion expandable with an inflatable body may be disclosed.
This disclosure is directed to prosthetic heart valves and actuators for prosthetic heart valves. In some examples, the actuator can comprise an internally threaded bore that engages an externally threaded portion of the frame component, such as a stationary post. In some examples, the actuator can comprise an externally threaded end portion that engages an internally threaded bore in a frame component, such as a stationary post.
A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.
Collapsible coil antennas for implantable medical devices are described. Collapsible coil antennas are capable of expanding and contracting without breaking, while maintaining their functionality as antennas. In many aspects, they are made from a drawn filled tube having three layers, and the drawn filled tube is formed into the shape of a crown.
A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.
A61F 2/958 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes ballons gonflables pour insérer les stents ou les endoprothèses déployables couvertes
A device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The device or implant can include connectors that hold movable components of the device together. Components of the device or implant can include flex limiting portions. Paddle frames of the device or implant can be configured to be moved between wide and narrow configurations while substantially maintaining a position where valve leaflets are pressed together by the paddle frames. Paddle frames and/or connectors that widen and narrow the paddle frames can be tapered.
An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The device can be deployed from a delivery system including one or more lines which can be decoupled from the device by energizing. The device can include contoured clasps which approximate the shape of the native valve when the clasps are in the closed position. The device can include a coaptation element with body portion including a plurality of struts and openings defining a lattice structure. One or more surfaces of one or more components of the device can be coated to improve the visibility of the device during deployment and implantation.
An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The implantable device can be removed using one or more of a cutting device, a capture device, and a stabilization component. The stabilization component can control the position of the implantable device while the cutting device resects one or more of the leaflets to which the implantable device is engaged.
A61B 18/00 - Instruments, dispositifs ou procédés chirurgicaux pour transférer des formes non mécaniques d'énergie vers le corps ou à partir de celui-ci
A61B 18/18 - Instruments, dispositifs ou procédés chirurgicaux pour transférer des formes non mécaniques d'énergie vers le corps ou à partir de celui-ci par application de radiations électromagnétiques, p.ex. de micro-ondes
Introducers and dilators that include expansion features configured to dilate expandable access sheaths, and expandable access sheaths, are described herein. The introducer can include an expansion feature disposed on an elongate shaft. The expansion feature can include a larger outer diameter than the distal end of the elongate shaft or another portion of the elongate shaft. The expansion feature can be configured to dilate a portion of an expandable access sheath when the elongate shaft is translated within the expandable access sheath. Expandable access sheaths can comprise expandable distal end portions configured to be maintained in a closed state by, for example, a tensioned cord portion disposed around a circumferential portion of the expandable distal end portion, a plurality of pleats comprising material configured to attract one another, a circumferential portion with a weakened joint, and/or a weakened portion on a sidewall of the expandable distal end portion.
A medical device delivery system can comprise a delivery catheter and an in-line sheath, the delivery catheter being preloaded within the in-line sheath. The delivery catheter can comprise a catheter hub and a catheter shaft. The catheter shaft can comprise a proximal portion extending distally from the hub and slidably receiving a proximal narrow portion of a medical device, and a distal portion slidably receiving a distal wide portion of a medical device. The in-line sheath can comprise a sheath hub and a sheath shaft. The sheath shaft can comprise a proximal portion extending distally from the sheath hub and slidably receiving at least a portion of the proximal portion of the catheter shaft, and an expandable distal portion slidably receiving the distal portion of the catheter shaft.
A61M 60/187 - Pompes ou dispositifs de pompage implantables, c.-à-d. que le sang est pompé à l’intérieur du corps du patient implantables dans ou sur le cœur, ou autour du cœur agissant mécaniquement sur l’intérieur du cœur natif du patient, p.ex. structures contractiles placées à l’intérieur du cœur
A61M 60/289 - Dispositifs de circulation mécanique pour assistance de la fonction cardiaque résiduelle par action mécanique sur le cœur natif ou la structure de vaisseaux sanguins du patient, p.ex. dispositifs de compression cardiaque directe
A61M 60/465 - Pompes pour le sang; Dispositifs pour l'actionnement mécanique de la circulation; Pompes à ballon d’assistance circulatoire - Détails concernant l’entraînement pour des dispositifs d’actionnement circulatoire mécanique
20.
BALLOON COVER FOR A DELIVERY APPARATUS FOR AN EXPANDABLE PROSTHETIC HEART VALVE
Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each of the first and second shell members including a first portion and a second portion, the second portion having a larger width than the first portion. The first portions of the first and second shell members define a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery apparatus. The second portions of the first and second shell members define a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery apparatus, proximal to a valve mounting portion of the distal end portion of the delivery apparatus.
A61B 50/30 - Récipients spécialement adaptés à l'emballage, la protection, la distribution, la collecte ou l'élimination des appareils ou des instruments chirurgicaux ou de diagnostic
A61F 2/95 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes
A61F 2/958 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes ballons gonflables pour insérer les stents ou les endoprothèses déployables couvertes
A tissue anchor comprises a frame comprising at least a first pointed end and a membrane extending across an opening of the frame. The frame is configured to bend such that the first pointed end extends at least partially over the membrane.
A prosthetic valve includes a radially expandable and compressible frame, a leaflet assembly comprising a plurality of leaflets coupled to the frame, and an outer skirt positioned around an outer surface of the frame. The outer skirt includes a tissue layer and a non-tissue layer. The tissue layer has a fibrous side and a smooth side. The non-tissue layer is coupled to the smooth side of the tissue layer. The outer skirt is positioned so that the fibrous side of the tissue layer faces away from the frame and the non-tissue layer faces towards the frame.
Prosthetic heart valves are disclosed. As an example, a prosthetic heart valve comprises a frame having an inflow end and an outflow end that is expandable between a radially compressed configuration and a radially expanded configuration; and a skirt disposed around an outer surface of the frame and having an inflow portion and an outflow portion, the skirt comprising a first plurality of axially extending fibers disposed in the inflow portion and a second plurality of axially extending fibers disposed in the outflow portion, wherein each of the first plurality of fibers include two fixed ends, wherein at least one of the second plurality of fibers includes a free end and a fixed end.
Various implementations include an expandable sheath system (300) including a radially expandable sheath (208) including a restraining member (385) limiting expansion of the sheath and methods of making the same.
In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.
A method is disclosed for monitoring arterial pressure of a patient and identifying nociception of the patient. The method includes receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient. Waveform analysis is performed by the hemodynamic monitor of the sensed hemodynamic data to calculate a first signal measure and a second signal measure. Both the first and second signal measures are processed by the hemodynamic monitor through a cumulative sum (CUSUM) algorithm to acquire a first CUSUM output for the first signal measure and a second CUSUM output for the second signal measure. A nociception event of the patient is detected when a change in the first CUSUM output overlaps in time with a change in the second CUSUM output. A sensory signal is outputted to a user interface of the hemodynamic monitor to warn medical personnel of the nociception event.
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
A61B 5/02 - Mesure du pouls, du rythme cardiaque, de la pression sanguine ou du débit sanguin; Détermination combinée du pouls, du rythme cardiaque, de la pression sanguine; Evaluation d'un état cardio-vasculaire non prévue ailleurs, p.ex. utilisant la combinaison de techniques prévues dans le présent groupe et des techniques d'électrocardiographie; Sondes cardiaques pour mesurer la pression sanguine
A61B 5/0205 - Evaluation simultanée de l'état cardio-vasculaire et de l'état d'autres parties du corps, p.ex. de l'état cardiaque et respiratoire
A61B 5/021 - Mesure de la pression dans le cœur ou dans les vaisseaux sanguins
A61B 5/024 - Mesure du pouls ou des pulsations cardiaques
A61B 5/08 - Dispositifs de mesure pour examiner les organes respiratoires
G16H 10/60 - TIC spécialement adaptées au maniement ou au traitement des données médicales ou de soins de santé relatives aux patients pour des données spécifiques de patients, p.ex. pour des dossiers électroniques de patients
G16H 50/30 - TIC spécialement adaptées au diagnostic médical, à la simulation médicale ou à l’extraction de données médicales; TIC spécialement adaptées à la détection, au suivi ou à la modélisation d’épidémies ou de pandémies pour l’évaluation des risques pour la santé d’une personne
A method of manufacturing an integrated, flexible diaphragm for a pressure sensor using a physical vapor deposition process (PVD), including: providing a mandrel form, the mandrel form including a body portion and a diaphragm portion, placing the mandrel form in a vacuum deposition chamber, depositing a plurality of base layers of a material over at least a portion of the body portion of the mandrel form surrounding the diaphragm portion, and depositing a skin layer over the diaphragm portion and over the deposited plurality of base layers around the diaphragm portion to form the integrated, flexible diaphragm.
An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The implantable device or implant can expand and contract. For example, the implantable device or implant can narrow during delivery and expand on implantation on the native heart valve.
An anchoring device that can be positioned within a native valve, such as the native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can comprise a docking station formed of a super elastic wire-like member defining a continuous, closed shape. The docking station can have an upper or atrial ring with at least two ring portions or half rings that are spaced apart across gaps. Descending bends from the ends of the two ring portions lead to a pair of anchors. The anchors can include oppositely-directed rounded V-shaped arms that extend generally parallel to the upper ring. When installed by a delivery device, the anchors can be located in the subvalvular space or the region/vicinity of the native leaflets and pinch the leaflets and the annulus against the upper ring which is located on the other side of the annulus.
A delivery apparatus for a prosthetic heart valve can comprise a shaft having a proximal end portion and a distal end portion, and an inflatable balloon mounted on the distal end portion of the shaft. The inflatable balloon can comprise a first conical portion, a second conical portion axially disposed relative to the first conical portion, and a central longitudinal axis extending between the first conical portion and the second conical portion. The first conical portion can have a first axial length and the second conical portion can have a second axial length that is different than the first axial length. The first conical portion has a first slope relative to the central longitudinal axis and the second conical portion has a second slope relative to the central longitudinal axis that is different than the first slope.
A61F 2/958 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes ballons gonflables pour insérer les stents ou les endoprothèses déployables couvertes
Aspects of a sheath are disclosed herein including a radially expandable outer cylinder and including a plurality of sheath fins distributed circumferentially about the inner surface of the central lumen of the sheath. Each of the fins extends along a length of the inner surface of the sheath and when the sheath not expanded, the form a continuous inner surface of the sheath lumen. Each of the sheath fins includes a longitudinally-extending leading edge and a longitudinally-extending trailing edge where the leading edge of each of the sheath fins abuts a trailing edge of an adjacent one of the sheath fins when the sheath is in the unexpanded state, and in an initial unexpanded state adjacent sheath fins are coupled together along their leading edge and trailing edges.
Systems, devices, and methods for shunting blood from one anatomical chamber/vessel to another anatomical chamber/vessel are described. For example, a dual frame shunt can include an anchoring frame/structure that is configured to self-expand and to anchor the shunt within an opening between two anatomical chambers/features. The shunt can also include an adjustable frame/structure disposed outside or inside of at least a portion of the anchoring frame and configured to expand/adjust to various sizes.
A handle assembly for controlling the implantable device includes an actuation element extending through a sheath, a paddle actuation control coupled to the actuation element, and a visual indicator. In some implementations, the handle further includes a paddle width adjustment element and a paddle width control that is actuatable to cause axial movement of the paddle width adjustment element, thereby causing a width of the at least one of the pair of paddles of the implantable device to be moved from a first width to a second width. In some implementations, the visual indicator is coupled to the actuation element or the paddle width adjustment element through the handle housing and is configured to provide an indication regarding a configuration of the implantable device.
A steerable medical apparatus includes a shaft, a steering mechanism, and an actuation mechanism. The shaft has a proximal portion, a distal portion, a first pull wire, and a second pull wire. The distal ends of the first and second pull wires are coupled to the distal portion of the shaft. The steering mechanism has a first wheel and a second wheel coupled by a differential mechanism. The proximal ends of the first and second pull wires are respectively coupled to the first and second wheels. The actuation mechanism is coupled to the steering mechanism. Actuating the actuation mechanism in a first operational mode causes the distal portion of the shaft to curve in a first plane. Actuating the actuation mechanism in a second operational mode causes the distal portion of the shaft to curve away from the first plane.
A61B 17/00 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets
A61B 18/00 - Instruments, dispositifs ou procédés chirurgicaux pour transférer des formes non mécaniques d'énergie vers le corps ou à partir de celui-ci
Disclosed herein are steerable catheter assemblies and handles for steerable catheter assemblies. Some implementations include a catheter with two or more pull wires that flex the catheter and a control handle coupled to the catheter. The control handle can include a housing, first, second, third, and fourth followers in the housing, and first and second drivers. Rotation of the first driver moves the first and second followers in opposite directions. Rotation of the second driver moves the third and fourth followers in opposite directions.
Steerable delivery apparatuses with lumen liner seals and associated methods. In an example, a steerable delivery apparatus includes a flexible tube, a control wire lumen liner at least partially defining a control wire lumen, a control wire disposed within the control wire lumen, a coil sleeve disposed around the control wire, a coil stopper abutting the coil sleeve, and a lumen liner seal that forms an at least substantially fluid-tight seal between the control wire lumen liner and the coil stopper. In another example, a method includes positioning a control wire lumen liner proximate to a coil stopper, positioning a lumen liner seal over a portion of each of the control wire lumen liner and the coil stopper, and transitioning the lumen liner seal to a contracted configuration to form an at least substantially fluid-tight seal between the control wire lumen liner and the coil stopper.
An implantable sensor device includes a cylindrical housing, a deflectable diaphragm associated with a sidewall of the housing, and a pressure sensor device housed within the housing. A transduction medium is disposed within the housing over at least a portion of the pressure sensor device.
A prosthetic heart valve includes a multi-part frame having a first annular body and an anchor component that includes a second annular body circumscribing the first annular body. The first annular body includes a plurality of struts arranged in a lattice pattern and defining a lumen. The anchor component further includes one or more ventricular anchors extending from the second annular body toward an inflow end portion of the first annular body. A fabric layer is disposed on an inner surface of the first annular body and sutured to the struts. A valve structure including three leaflets is disposed within the lumen and inlet ends of the leaflets are sutured to the fabric layer. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of a native valve.
Disclosed herein are stabilizer systems that include a base for securing the stabilizer system to a patient table by inserting the base between the patient table and the mattress on the patient table. The stabilizer systems also include a connector that connects a lockable articulating arm to the base. The base protrudes from under the mattress slightly to provide a sturdy and predictable surface to attach the articulating arm of the stabilizer system. The base can then be used to support a lockable articulating arm with a clamp at its distal end for holding an access sheath or delivery system. The connectors attach the articulating arm to the base so that the articulating arm is above the sterile surgical drape to maintain sterility of the articulating arm. The stabilizer systems are advantageous in jugular access procedures.
A method includes advancing a delivery assembly through a patient's vasculature toward a native heart valve of the patient, wherein the delivery assembly comprises a first catheter assembly and a second catheter assembly extending through a shaft of the first catheter assembly, and wherein a support member is in an uncoiled, elongated configuration within a sheath of the first catheter assembly. The support member is deployed from the sheath by pushing the second catheter assembly distally relative to the first catheter assembly so that the support member is uncovered by the sheath and the support member extends around native chordae tendineae and native leaflets of the native heart valve. A prosthetic valve is implanted within the native leaflets of the native heart valve such that the native leaflets are frictionally engaged between the support member and the prosthetic valve.
Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for a cardiovascular device, then return to a non-expanded state after the passage of the device. The sheath includes an elongated annular member having longitudinally extending channels that facilitate the sheath's temporary expansion. The channels are positioned in such a way that, upon expansion, they enable the movement of protruding contact surfaces toward the inner and outer surfaces of the annular member, reducing friction between the surface and the passing device. Some embodiments of the expandable sheath include an elastic outer layer that pushes the protruding contact surfaces back towards their original positions after the passage of the device.
A61F 2/95 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes
A61F 2/966 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes possédant une gaine extérieure avec un mouvement longitudinal relatif entre la gaine extérieure et la prothèse, p.ex. utilisant une tige poussoir
A61M 25/04 - Dispositifs de maintien en position, p.ex. sur le corps à l'intérieur du corps, p.ex. expansibles
A61M 25/06 - Aiguilles avec un guide pour piquer le corps ou analogues
B29C 48/09 - Objets dont la section transversale comporte des cavités partiellement ou entièrement fermées, p.ex. tuyaux ou canaux
B29C 57/00 - Façonnage d'extrémités de tubes, p.ex. formage de brides, tulipage ou fermeture; Appareils à cet effet
45.
HEART VALVE REPAIR DEVICES AND DELIVERY DEVICES THEREFOR
A valve repair device and valve repair systems including a delivery device and a valve repair device for repairing a native valve of a subject. The valve repair device and/or the delivery device having one or more force measurement devices for detecting a force applied to the native valve of a subject due to the connection between the valve repair device and the native valve.
A61B 90/00 - Instruments, outillage ou accessoires spécialement adaptés à la chirurgie ou au diagnostic non couverts par l'un des groupes , p.ex. pour le traitement de la luxation ou pour la protection de bords de blessures
Systems and methods for synthesis of covers for valvular prosthetics are described. Generally, covers can be synthesized via depositing, submersion, and/or printing. Covers can be synthesized directly onto a valvular frame or synthesized on a temporary substrate and transferred onto the valvular frame. Covers can be synthesized having one or more layers. The covers and the various layers can be synthesized or treated to obtain beneficial properties.
A valve repair device for repairing a native valve of a patient. The valve repair device having one or more adjustable width paddle frame portions. The adjustable width paddle frame portions having an anterior portion extending from the medial side of the device to the lateral side of the device and a posterior portion extending from the medial side of the device and a lateral side of the device opposite the anterior portion. The anterior portion and the posterior portion are formed as a single frame member integrally joined at linking portions at the medial side of the device and a lateral side of the device. A connector includes attachment portions that connect to the linking portions to attach the adjustable width frame portion to the connector.
An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. In some examples, a plurality of sutures is employed to secure frame portions of the implantable device to a connector of the implantable device. Each of the sutures can be passed through one or more eyelets of the frame portions and the connector. In some examples, an implantable device includes an actuation cap having a flexible portion or a biasing element positioned between an end portion of the actuation cap and an anchor portion of the implantable device. The flexible portion or the biasing element flex or compress responsive to forces between the connector and the actuation cap.
In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube and a nose cone cap. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. The nose cone cap and the storage tube have mating first and second locking member that can be coupled to selectively secure the nose cone cap to the storage tube.
A61F 2/00 - Filtres implantables dans les vaisseaux sanguins; Prothèses, c.-à-d. éléments de substitution ou de remplacement pour des parties du corps; Appareils pour les assujettir au corps; Dispositifs maintenant le passage ou évitant l'affaissement de structures corporelles tubulaires, p.ex. stents
A system disclosed herein includes a hardware processor and a predictive risk model training software code stored in a system memory. The hardware processor executes the software code to receive vital sign data of a population of subjects including positive and negative subjects with respect to a health state, to define data sets for use in training a predictive risk model, to transform the vital sign data to parameters characterizing the vital sign data, and to obtain differential parameters based on those parameters. The hardware processor executes the software code to further generate combinatorial parameters using the parameters and the differential parameters, to analyze the parameters, the differential parameters, and the combinatorial parameters to identify a reduced set of parameters correlated with the health state, to identify a predictive set of parameters enabling prediction of the health state for a living subject, and to compute predictive risk model coefficients.
G06N 5/04 - Modèles d’inférence ou de raisonnement
G16H 50/30 - TIC spécialement adaptées au diagnostic médical, à la simulation médicale ou à l’extraction de données médicales; TIC spécialement adaptées à la détection, au suivi ou à la modélisation d’épidémies ou de pandémies pour l’évaluation des risques pour la santé d’une personne
G16H 50/70 - TIC spécialement adaptées au diagnostic médical, à la simulation médicale ou à l’extraction de données médicales; TIC spécialement adaptées à la détection, au suivi ou à la modélisation d’épidémies ou de pandémies pour extraire des données médicales, p.ex. pour analyser les cas antérieurs d’autres patients
A medical implant for managing blood flow comprises a frame configured for deployment within a first blood vessel and configured to extend at least partially across a first in-flow junction of a second blood vessel, the frame at least partially composed of wire-like struts configured to allow at least partial blood flow through gaps between struts.
A61F 2/00 - Filtres implantables dans les vaisseaux sanguins; Prothèses, c.-à-d. éléments de substitution ou de remplacement pour des parties du corps; Appareils pour les assujettir au corps; Dispositifs maintenant le passage ou évitant l'affaissement de structures corporelles tubulaires, p.ex. stents
Described herein are shunt devices configured to achieve a targeted reduction in peak systolic pressure by percutaneous ly shunting from the superior vena cava to the right pulmonary artery. The shunt devices include a check valve with a cracking pressure to preserve a minimal transpulmonary pressure. Also described herein are flow diversion devices placed between pulmonary circulation vessels and venous vessels. The disclosed flow diversion devices are physiologically responsive through an adjustable orifice that can be adjusted after initial implantation through a non-invasive or minimally invasive procedure. Disclosed herein are flow control systems that are configured to reduce recruitment of blood from the splanchnic system. The flow control systems include a variable orifice constrictor (e.g., a covered stent) and a controller that delivers energy to the constrictor to reduce the cross-sectional area of the lumen through the variable orifice constrictor.
A61B 17/11 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets pour refermer les plaies ou les maintenir fermées, p.ex. agrafes chirurgicales; Accessoires utilisés en liaison avec ces opérations pour réaliser l'anastomose; Boutons pour anastomose
A61F 2/82 - Dispositifs maintenant le passage ou évitant l’affaissement de structures tubulaires du corps, p.ex. stents
An implant delivery system comprises a distal portion configured to naturally assume a first width and expand beyond the first width in response to an implant device being inserted into the distal portion via an opening at a distal end of the distal portion and a proximal portion configured to generally maintain the first width
A61M 60/865 - Dispositifs de guidage ou d’insertion de pompes ou dispositifs de pompage à l’intérieur du corps du patient
A61M 60/139 - Pompes ou dispositifs de pompage implantables, c.-à-d. que le sang est pompé à l’intérieur du corps du patient implantables par, dans, à l’intérieur, en ligne, se ramifiant dans ou autour d’un vaisseau sanguin à l’intérieur d’un vaisseau sanguin, p.ex. par greffe à l’intérieur de l’aorte, p.ex. pompes à ballon intra-aortiques
54.
SYSTEMS AND METHODS FOR FORCE REDUCTION IN DELIVERY SYSTEMS
Examples of the present disclosure may be directed to reducing a tension force or a compression force in one or more shafts of the delivery system. An elongate catheter may include the one or more shafts. The tension force or compression force may result from residual tension or compression in a shaft resulting from movement of the shaft. The tension force or compression force may alternatively or in combination result from interacting forces across a plurality of the shafts. The tension force or compression force may hinder the operation of the delivery system and in instances may damage the delivery system. Systems, devices, and methods for reducing the tension force or compression force are disclosed herein.
A shunt implant device includes one or more anchor arms and first and second barrel wings configured to curve to form a tubular barrel form. In some implementations, shunt implant devices of the present disclosure include a shunt barrel formed at least in part by a plurality of arcuate panels configured in an at least partially cylindrical form, a first anchor arm projecting from a first axial side of the shunt barrel and deflected radially outward in a first radial direction, and a second anchor arm projecting from a second axial side of the shunt barrel and deflected radially outward in the first radial direction.
A valve repair device for repairing a native valve of a patient includes a pair of paddles and an expanding spacer. The paddles are movable between an open position and a closed position. The expanding spacer is disposed between the pair of paddles. The expanding spacer is configured to be expanded between the paddles when the paddles are moved from the open position to the closed position. The expanding spacer is configured to fill at least a portion of a gap in the native valve of the patient when the valve repair device is attached to the native valve and the expanding spacer is expanded.
A medical access system can comprise an inner needle assembly including an inner needle shaft configured to be slidably disposed at least partially within a delivery lumen of an outer needle assembly, the inner needle shaft comprising a narrower distal portion and a wider portion proximal of the narrower distal portion, and a transition segment between the narrower distal portion and the wider portion. A first delivery lumen within the inner needle shaft can extend from a proximal end of the inner needle shaft to a distal end opening at a distal end of the narrower distal portion, and a second delivery lumen within the inner needle shaft can extend from the proximal end to a distal opening associated with the transition segment.
Systems and methods arc for evaluating preload responsiveness utilizing hemodynamic data that is derived from a continuous blood pressure or blood flow sensor representative of right-side measurements from the heart. Hemodynamic data features can be derived from a blood pressure or blood flow waveform and utilized to determine hemodynamic parameters to guide fluid resuscitation treatment and/or maintain the health and wellbeing of a patient that, such as a patient under monitoring during a surgery. In one example, beat-to-beat right-side stroke volume variation (SVV) is determined as a function of the standard deviation of the blood pressure waveform over a plurality of cardiac cycles.
A61B 5/02 - Mesure du pouls, du rythme cardiaque, de la pression sanguine ou du débit sanguin; Détermination combinée du pouls, du rythme cardiaque, de la pression sanguine; Evaluation d'un état cardio-vasculaire non prévue ailleurs, p.ex. utilisant la combinaison de techniques prévues dans le présent groupe et des techniques d'électrocardiographie; Sondes cardiaques pour mesurer la pression sanguine
A system for monitoring right ventricular systolic dysfunction includes a hemodynamic sensor that produces a hemodynamic sensor signal representative of a right ventricular pressure waveform of the patient, a display, one or more processors, and computer-readable memory. The computer-readable memory is encoded with instructions that, when executed by the one or more processors, cause the system to receive the hemodynamic sensor signal representative of the right ventricular pressure waveform of the patient, extract right ventricular peak systolic pressure and right ventricular end diastolic pressure from the right ventricular pressure waveform of the patient, determine a ratio of right ventricular peak systolic pressure over right ventricular end diastolic pressure, and output the ratio of right ventricular peak systolic pressure over right ventricular end diastolic pressure to the display for monitoring the presence of right ventricular systolic dysfunction based on the ratio of peak systolic pressure over end diastolic pressure.
A61B 5/02 - Mesure du pouls, du rythme cardiaque, de la pression sanguine ou du débit sanguin; Détermination combinée du pouls, du rythme cardiaque, de la pression sanguine; Evaluation d'un état cardio-vasculaire non prévue ailleurs, p.ex. utilisant la combinaison de techniques prévues dans le présent groupe et des techniques d'électrocardiographie; Sondes cardiaques pour mesurer la pression sanguine
A61B 5/0215 - Mesure de la pression dans le cœur ou dans les vaisseaux sanguins par des moyens introduits dans le corps
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
60.
TRANSCATHETER HEART VALVES WITH IMPROVED BLOOD FLOW
A prosthetic heart valve includes three prosthetic valve leaflets coupled together at three commissure regions to form a central flow path. A collapsible and expandable valve frame is provided for supporting the prosthetic valve leaflets. The valve frame includes three cantilevered support arms for supporting the three commissure regions and gaps are provided between the three cantilevered support arms for improving leaflet coaptation and reducing thrombus formation. The valve frame is positioned within an outer sealing frame and the sealing frame anchors to surrounding heart tissue. The prosthetic heart valve is adapted to be delivered using a minimally invasive transcatheter procedure. The prosthetic heart valve is preferably used for replacing a native mitral or tricuspid valve.
Devices and methods for replacing a malformed or defective heart are provided. The devices can include a flexible hollow structure sized for deployment within the right side of a human heart. The hollow structure preferably includes an inlet, an outlet, and a one-way prosthetic valve. The hollow structure allows blood to pass therethrough and effectively replaces the function of the right side of the heart. The hollow structure is preferably flexible for allowing natural beating of the heart after deployment in the body. The device is particularly well-suited for treating a congenital malformation of the tricuspid valve known as Ebstein's anomaly.
A device for delivering a guidewire to a target location in a patient's body includes a hollow needle having: a lumen configured to receive the guidewire; a body section; and a biased section, the biased section configured to bend relative to the body section, the biased section located on a distal end of the hollow needle. The device includes a catheter having a catheter lumen, the catheter lumen configured to: receive the hollow needle, and maintain the biased section and the body section in relative alignment in a first configuration. The hollow needle, in response to the biased section extending out from the catheter, is configured to bend the biased section relative to the body section in a second configuration.
A medical implant device can comprise a light source and a light sensor, and a housing configured to receive the light source and the light sensor. The housing can comprise a first wall portion configured to be positioned over an extraluminal surface of a coronary sinus, the first wall portion comprising a first surface oriented toward the extraluminal surface. A first light-transparent region of the first wall portion can be configured to allow passage therethrough of an emitted light signal from the light source into the coronary sinus, and a second light-transparent region of the first wall portion can be configured to allow passage therethrough of a reflected light signal from within the coronary sinus for detection by the light sensor.
A61B 5/1455 - Mesure des caractéristiques du sang in vivo, p.ex. de la concentration des gaz dans le sang, de la valeur du pH du sang en utilisant des capteurs optiques, p.ex. des oxymètres à photométrie spectrale
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
A61B 5/145 - Mesure des caractéristiques du sang in vivo, p.ex. de la concentration des gaz dans le sang, de la valeur du pH du sang
64.
DETECTING AND DIFFERENTIATING NOCICEPTION EVENTS FROM HEMODYNAMIC DRUG ADMINISTRATION EVENTS
A method for monitoring arterial pressure of a patient and warning medical personnel of current nociception of the patient includes the hemodynamic monitor receiving sensed hemodynamic data representative of an arterial pressure waveform of the patient. The hemodynamic monitor performs waveform analysis of the sensed hemodynamic data to calculate a plurality of signal measures. Detection input features, hemodynamic drug detection input features, and stable detection input features are extracted from the plurality of signal measures. A first probability is determined based on the detection input features and the hemodynamic drug detection input features. A second probability is determined based on the detection input features and the stable detection input features. The hemodynamic monitor compares the second probability with the first probability to determine an output probability of the current nociception of the patient. The hemodynamic monitor invokes a sensory alarm in response to the output probability satisfying a predetermined criterion.
A61B 5/022 - Mesure de la pression dans le cœur ou dans les vaisseaux sanguins par application d'une pression pour fermer les vaisseaux sanguins, p.ex. contre la peau; Ophtalmodynamomètres
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
A61B 5/02 - Mesure du pouls, du rythme cardiaque, de la pression sanguine ou du débit sanguin; Détermination combinée du pouls, du rythme cardiaque, de la pression sanguine; Evaluation d'un état cardio-vasculaire non prévue ailleurs, p.ex. utilisant la combinaison de techniques prévues dans le présent groupe et des techniques d'électrocardiographie; Sondes cardiaques pour mesurer la pression sanguine
A61B 5/0205 - Evaluation simultanée de l'état cardio-vasculaire et de l'état d'autres parties du corps, p.ex. de l'état cardiaque et respiratoire
A61B 5/024 - Mesure du pouls ou des pulsations cardiaques
A61B 5/08 - Dispositifs de mesure pour examiner les organes respiratoires
G16H 10/60 - TIC spécialement adaptées au maniement ou au traitement des données médicales ou de soins de santé relatives aux patients pour des données spécifiques de patients, p.ex. pour des dossiers électroniques de patients
Devices and methods for providing fluid to a lumen of a guide catheter with a fluid reservoir fluidly coupled to the lumen, such that pressure within the lumen is maintained at a desired level, are disclosed. As one example, a delivery apparatus can include a handle, a shaft extending within and distally from the handle and having a main lumen, and a reservoir fluidly coupled to the main lumen. The reservoir is filled with fluid and has an adjustable fluid volume, and the reservoir is configured to passively supply fluid to the main lumen based on a fluid pressure in the main lumen.
A color-coded bioprosthetic valve system having a valve with an annular sewing ring, and a valve holder system with a holder sutured to the ring of the valve, a post operatively connected to the holder, and an adapter sutured to the post and having a color associated with the valve model and/or size. For example, the adapter may be blue to indicate that the valve of the system is a mitral valve of a particular type and/or size. The system may also include a flex handle that is configured to engage with the adapter. The handle has a color associated with the adapter such that a user is able to visually determine that the handle color matches the valve model. For example, the handle may have a grip that is colored blue to match the blue color of the adapter. Accordingly, the color-coded system enables users to confirm easily that the correct accessories such as the sizer or flex handle are being used with the correct valve.
A system for monitoring hemodynamic data of a patient and providing a risk score representative of a likelihood of a right ventricular dysfunction event includes at least two hemodynamic sensors, a system memory, a user interface display, and a hardware processor. The hardware processor executes a right ventricular prediction software code stored within the system memory to receive hemodynamic data representative of a right ventricular pressure waveform of the patient and at least one of a pulmonary artery pressure waveform, a tissue oxygen saturation, a mixed venous oxygen saturation, and a cardiac output of the patient. Based on the hemodynamic data, the system determines and outputs the risk score to the display.
A61B 5/0205 - Evaluation simultanée de l'état cardio-vasculaire et de l'état d'autres parties du corps, p.ex. de l'état cardiaque et respiratoire
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
A61B 5/01 - Mesure de la température de parties du corps
A61B 5/02 - Mesure du pouls, du rythme cardiaque, de la pression sanguine ou du débit sanguin; Détermination combinée du pouls, du rythme cardiaque, de la pression sanguine; Evaluation d'un état cardio-vasculaire non prévue ailleurs, p.ex. utilisant la combinaison de techniques prévues dans le présent groupe et des techniques d'électrocardiographie; Sondes cardiaques pour mesurer la pression sanguine
A61B 5/021 - Mesure de la pression dans le cœur ou dans les vaisseaux sanguins
A61B 5/0215 - Mesure de la pression dans le cœur ou dans les vaisseaux sanguins par des moyens introduits dans le corps
A61B 5/024 - Mesure du pouls ou des pulsations cardiaques
A61B 5/1455 - Mesure des caractéristiques du sang in vivo, p.ex. de la concentration des gaz dans le sang, de la valeur du pH du sang en utilisant des capteurs optiques, p.ex. des oxymètres à photométrie spectrale
G16H 50/30 - TIC spécialement adaptées au diagnostic médical, à la simulation médicale ou à l’extraction de données médicales; TIC spécialement adaptées à la détection, au suivi ou à la modélisation d’épidémies ou de pandémies pour l’évaluation des risques pour la santé d’une personne
G16H 50/70 - TIC spécialement adaptées au diagnostic médical, à la simulation médicale ou à l’extraction de données médicales; TIC spécialement adaptées à la détection, au suivi ou à la modélisation d’épidémies ou de pandémies pour extraire des données médicales, p.ex. pour analyser les cas antérieurs d’autres patients
A method for monitoring arterial pressure of a patient and detecting nociception of the patient includes receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient. A hardware processor of the hemodynamic monitor performs waveform analysis of the sensed hemodynamic data to calculate a plurality of signal measures of the sensed hemodynamic data. The hardware processor of the hemodynamic monitor calculates cross-correlational association measurements between each of the signal measures. The cross-correlational association measurements are outputted to a user interface. The cross-correlational association measurements are monitored for bursts in the cross-correlational association measurements. A nociception event of the patient is detected when a burst in one or more of the cross-correlational association measurements is outputted to the user interface.
A prosthetic valve includes an annular frame with a plurality of inflow apices and a plurality of outflow apices. Each one of the outflow apices can be circumferentially offset from a respective inflow apex. The prosthetic valve can further include a leaflet structure positioned within the frame and secured thereto. The prosthetic valve can further include an outer skirt secured to the frame. The outer skirt can include an upper edge portion disposed around an outer surface of the frame, a lower edge portion wrapped around the inflow apices, and a plurality of creases. Each crease can be circumferentially aligned with a corresponding outflow apex and can extend from the lower edge portion towards the upper edge portion. The inner skirt can be secured to an inner surface of the frame and can include a lower edge portion attached to the lower edge portion of the outer skirt.
A device may include a frame including an inflow end and an outflow end. The frame defines a lumen between the inflow end and the outflow end. A device may include a first expandable member coupled to at least one portion of an internal surface of the frame and including a first inflation port. The first expandable member defines a first volume configured to receive an inflation fluid therein through the first inflation port. The first expandable member is configured to be reversibly inflatable to a first plurality of inflation states to partially or fully occlude the lumen. The devices described herein may be used to treatment a subject having one or both of: congestive heart failure or chronic kidney disease.
A61M 60/135 - Pompes ou dispositifs de pompage implantables, c.-à-d. que le sang est pompé à l’intérieur du corps du patient implantables par, dans, à l’intérieur, en ligne, se ramifiant dans ou autour d’un vaisseau sanguin à l’intérieur d’un vaisseau sanguin, p.ex. par greffe
A61M 60/295 - Pompes à ballon pour assistance circulatoire
A61M 60/30 - Leurs finalités médicales étant autres que l’amélioration du débit cardiaque
A61M 60/531 - Régulation par des données du patient en temps réel par des données de tension artérielle, p.ex. provenant de capteurs de tension
A61M 60/843 - Aspects du ballon, p.ex. formes ou matériaux
A61M 60/861 - Connexions ou ancrages pour connecter ou ancrer les pompes ou dispositifs de pompage à des parties du corps du patient
A61M 60/892 - Vannes actives, c. à d. actionnées par une force externe
Inflatable devices are disclosed including a surface which has a network of polymer chains and is configured to be inflatable into a therapeutically or diagnostically useful shape, and at least one ultrashort laser pulse-formed modification in the surface. The network can, for example, include a network morphology that is substantially unchanged by modification with the ultrashort pulse laser. Ultrashort laser pulses can be laser pulses equal to or less than 1000 picoseconds in duration. Advantageously, the etching process uses a relatively low-heat laser to avoid significant heating of surrounding polymers while modifying the surface (and other structures) of the device. The process is configured so that the polymer chain morphology adjacent the modification is substantially unaffected by the low-heat laser. The resulting inflatable device has customized surface features while still retaining substantially homogenous polymer network morphology. This preserves the elasticity, especially the surface elasticity, of the inflatable device.
B21D 39/00 - Utilisation de procédés permettant d'assembler des objets ou des parties d'objets, p.ex. revêtement par des tôles, autrement que par placage; Dispositifs de mandrinage des tubes
B23K 26/06 - Mise en forme du faisceau laser, p.ex. à l’aide de masques ou de foyers multiples
B23K 26/0622 - Mise en forme du faisceau laser, p.ex. à l’aide de masques ou de foyers multiples par commande directe du faisceau laser par impulsions de mise en forme
B23K 26/361 - Enlèvement de matière pour l'ébarbage ou l'ébavurage mécanique
B23K 26/402 - Enlèvement de matière en tenant compte des propriétés du matériau à enlever en faisant intervenir des matériaux non métalliques, p.ex. des isolants
B23K 103/00 - Matières à braser, souder ou découper
An implantable prosthetic valve including a plurality of leaflets and an annular frame that is radially expandable from a radially compressed state to a radially expanded state. The prosthetic valve also includes a skirt assembly comprising a reinforcing layer sandwiched between a first encapsulating layer and a second encapsulating layer, which are made of a thin elastomeric material. The reinforcing layer comprises a first set of yarns and a second set of yarns interwoven in a leno weave pattern, wherein the first and second sets of yarns are non-perpendicular and non-parallel to a longitudinal axis of the frame when the valve is in the radially expanded state. The first encapsulating layer and the second encapsulating layer can be fused or bonded along specified regions and form one or more pockets that enable free movement of sections of the reinforcing layer disposed therein.
A dilator (400) including: a dilator shaft (410); a knob (430) coupled to a proximal end of the dilator shaft; a dilator hub (450) rotatably coupled to the knob; and a pin coupling the dilator hub with the dilator shaft and preventing rotational movement therebetween, wherein rotational movement of the knob results in a corresponding axial movement of the dilator shaft in a direction along a longitudinal axis of the dilator.
A61F 2/966 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes possédant une gaine extérieure avec un mouvement longitudinal relatif entre la gaine extérieure et la prothèse, p.ex. utilisant une tige poussoir
74.
IMPEDANCE-BASED TISSUE CAPTURE CONFIRMATION SYSTEM FOR A SHUNT DEVICE
A device for determining tissue capture of a shunt device includes a delivery catheter and a shunt device disposed on the delivery catheter. The shunt device is configured to be inserted into a puncture in a tissue wall and includes a central flow tube extending from a first axial end to a second axial end, a first distal arm attached to the first axial end of the central flow tube, and a first proximal arm attached to the second axial end of the central flow tube. The first distal arm and the first proximal arm configured to capture the tissue wall therebetween, and the delivery catheter includes a first conductive wire and a second conductive wire. The first conductive wire is electrically connected to the shunt device and the second conductive wire is separated from the shunt device.
A61B 17/11 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets pour refermer les plaies ou les maintenir fermées, p.ex. agrafes chirurgicales; Accessoires utilisés en liaison avec ces opérations pour réaliser l'anastomose; Boutons pour anastomose
75.
SYSTEMS FOR EPICARDIAL TISSUE DISTENSION SOLUTIONS
Systems and methods for improving epicardial tissue distension are described. Drug delivery elements can deliver drugs that can dissolve epicardial fat and/or weaken pericardial connective tissue. Distension systems can provide mechanical distension of the pericardium. The drug delivery and the distension systems can be combined to improve epicardial tissue distension.
A prosthetic implant transitionable between a delivery configuration and a deployed configuration in-situ, the prosthetic implant includes a first frame subcomponent and a second frame subcomponent. The first frame subcomponent and the second frame subcomponent each include a proximal end and a distal end. The second frame subcomponent is coupled to the first frame subcomponent. When situated in the delivery configuration, the first frame subcomponent and the second frame subcomponent are longitudinally offset from one another. When transitioned to the deployed configuration in-situ, the first frame subcomponent is nested within an interior region defined by the second frame subcomponent. The prosthetic implant is configured to capture one or more of the native leaflets of a native valve when the first frame subcomponent and the second frame subcomponent are nested in-situ.
A clip may be configured to close the portion of the heart, to reduce blood flow therethrough as well as passage of clots or other undesired materials. The clip may be configured to close the left atrial appendage (LAA). The closure of the LAA may reduce the possibility of stroke or other maladies stemming from fluid flow with the LAA. Delivery systems may comprise expansion apparatuses for a left atrial appendage clip. The expansion apparatuses may include retention mechanisms for retaining the clip.
A61B 17/128 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets pour ligaturer ou comprimer par un autre moyen les parties tubulaires du corps, p.ex. les vaisseaux sanguins ou le cordon ombilical pour appliquer ou enlever les clamps ou les pinces
A61B 17/00 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets
A61B 90/00 - Instruments, outillage ou accessoires spécialement adaptés à la chirurgie ou au diagnostic non couverts par l'un des groupes , p.ex. pour le traitement de la luxation ou pour la protection de bords de blessures
A cross-plane seal having a distal end and a proximal end includes a disc at the distal end. The disc includes a distal face at a distal side, a proximal face at a proximal side, a plurality of cut outs in the distal face forming a raised X-shape on the distal face, a first slit having a partial through-cut into the distal face and aligned with a first leg of the raised X-shape, the through-cut extending more than halfway through the thickness of the disc, a second slit having a partial through-cut into the proximal face and aligned with a second leg of the raised X-shape, the through-cut extending more than halfway through the thickness of the disc, and an intersection formed by the first slit and the second slit. An annular portion is connected to and extends proximally away from the disc.
A prosthetic heart valve can include a radially expandable and compressible frame and a valvular structure. The frame can include a plurality of circumferentially spaced axial struts, a plurality of pairs of axial posts, and a plurality of rows of angled struts. Each pair of axial posts can be positioned circumferentially between two axial struts. The plurality of rows can include at least a first row, a second row downstream of the first row, a third row downstream of the second row, and a fourth row downstream of the third row. Each of the angled struts can be connected at one end to one of the axial struts and at another end to one of the axial posts. The angled struts of the first and fourth rows can be shorter than the struts of the second and third rows.
Prosthetic devices and frames for implantation at a cardiac valve annulus are provided that include an annular frame (having an inflow end and an outflow end) and a plurality of axial frame members that bridge two circumferentially extending rows of angled struts. The axial frame members can include a plurality of axially extending leaflet attachment members and a plurality of axial struts in a 1:1 ratio. Along each of the two rows, the frame can have at least three angled struts between adjacent axial frame members.
Delivery systems and methods of delivering devices or implants are disclosed. The devices or implants can be configured as valve repair devices or treatment devices have gripping members that are openable and closable to attach the device to leaflets of a native heart valve. The delivery systems are configured to position the device or implant and open and close the gripping members of the device or implant.
Described embodiments are directed toward centrally-opening leaflet prosthetic valves having a frame and a leaflet construct. Leaflet frame attachments for prosthetic valves include the leaflet construct being at least partially coupled to a frame outer side by a looped structure.
The present invention relates to systems, assemblies and methods for detecting attachment status of a prosthetic valve actuator. In an example, a prosthetic valve actuator attachment status detection system is constituted of: at least one actuator, a frame of the prosthetic valve movable by the at least one actuator between a radially compressed configuration and a radially expanded configuration, and at least one pressure sensor secured to the at least one actuator.
Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having synthetic leaflets that are configured to promote and encourage tissue ingrowth thereon and/or therein. The leaflets are coupled to a leaflet frame to form a prosthetic valve suitable for use in biological anatomy.
A61F 2/00 - Filtres implantables dans les vaisseaux sanguins; Prothèses, c.-à-d. éléments de substitution ou de remplacement pour des parties du corps; Appareils pour les assujettir au corps; Dispositifs maintenant le passage ou évitant l'affaissement de structures corporelles tubulaires, p.ex. stents
A61L 27/16 - Matériaux macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone
A61L 27/28 - Matériaux pour le revêtement de prothèses
A61L 27/50 - Matériaux caractérisés par leur fonction ou leurs propriétés physiques
A method of tethering can comprise providing a tether deployment device. The tether deployment device can comprise an elongate shaft comprising a lumen extending from a proximal end to a side opening, an atraumatic distal effector coupled to a distal end of the elongate shaft, and a tether deployment assembly at least partially received within the lumen. The method can include advancing the distal portion of the elongate shaft into a heart chamber, positioning a distally oriented surface of the atraumatic distal effector against a first tissue area, and advancing a distal portion of the tether deployment assembly through the side opening of the shaft. A portion of at least one tether can be deployed to the target tissue area using the tether deployment assembly while the distally oriented surface of the atraumatic distal effector is against the first tissue area.
A clip may be configured to close the portion of the heart, to reduce blood flow therethrough as well as passage of clots or other undesired materials. The clip may be configured to close the left atrial appendage (LAA). The closure of the LAA may reduce the possibility of stroke or other maladies stemming from fluid flow with the LAA.
A61B 17/128 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets pour ligaturer ou comprimer par un autre moyen les parties tubulaires du corps, p.ex. les vaisseaux sanguins ou le cordon ombilical pour appliquer ou enlever les clamps ou les pinces
87.
SYSTEM AND METHOD FOR CRIMPING AND LOADING A PROSTHETIC HEART VALVE
A system including a delivery apparatus, a crimping device, and a loading assembly. The crimping device includes a housing disposed over a distal end portion of the delivery apparatus for receiving a radially expandable and compressible prosthetic heart valve. The housing includes a funnel segment, a pusher member, and an actuator releasably coupled to the pusher member. Movement of the actuator causes the pusher member to advance the prosthetic heart valve through the funnel segment for radially compressing at least a portion of the prosthetic heart valve. Compression of the prosthetic heart valve facilitates secure attachment of the prosthetic heart valve to the delivery apparatus. The loading assembly can include an additional funnel member for fully crimping and loading the prosthetic heart valve into the delivery apparatus for advancement through a patient's vasculature.
This disclosure is directed to prosthetic heart valves and frames for prosthetic heart valves having actuation assemblies with at least two bolts coupled to each other. The actuation assembly with at least two bolts allow different portions of the actuation assembly to be designed to meet different needs. In one example, the actuation mechanism can include a first bolt coupled end-to-end with a second bolt. The second bolt can have a greater diameter and correspondingly greater mechanical strength than the first bolt. The first bolt can have a lesser diameter suitable for minimizing the thickness of surrounding and adjacent valve frame components. The actuation assembly can also include one or more of a nut, a washer, and a portion designed to attach to components of a delivery system. Also disclosed herein are actuation assemblies including a washer secured by a pin extending through the bolt of the actuation assembly.
Releasable retaining mechanisms for an actuator assembly of a delivery apparatus for an expandable prosthetic heart valve are disclosed. As one example, an actuator assembly can include an outer sleeve comprising a tube portion and an extension that extends distally from the tube portion and includes a first aperture in its distal end, an actuation member extending through the tube portion of the outer sleeve, and a retaining element configured to extend through the first aperture and hold the outer sleeve against an end portion of a frame of a prosthetic device. The retaining element is biased into a first position that holds the outer sleeve in engagement with the frame and is configured to flex in response to a pulling force into a second position that enables the retaining element to be released from the first aperture to disengage the outer sleeve from the end portion of the frame.
A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the frame attached thereto. The frame may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes an integrated handle shaft and balloon catheter. A valve holder is stored with the heart valve and the handle shaft easily attaches thereto to improve valve preparation steps.
A tissue anchor includes a memory metal wire configured to transition between an at least partially straightened delivery configuration and an expanded deployed configuration forming an anchor and a suture-attachment feature configured to have a suture coupled thereto. In the expanded deployed configuration, one or more portions of the memory metal wire extend radially outward from a center of the tissue anchor.
A61B 17/04 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets pour refermer les plaies ou les maintenir fermées, p.ex. agrafes chirurgicales; Accessoires utilisés en liaison avec ces opérations pour la suture des plaies; Supports ou emballages pour aiguilles ou matériaux de suture
A61B 17/06 - Aiguilles; Supports ou empaquetages pour aiguilles ou matériaux de suture
93.
OUTER COVERING WITH PROTRUDING SEALING MEMBERS FOR A PROSTHETIC HEART VALVE
Sealing members for an outer skirt of a prosthetic heart valve are disclosed. As one example, a prosthetic heart valve can include an annular frame, a plurality of leaflets arranged within an interior of the frame, and an outer skirt disposed around an outer surface of the frame. The outer skirt can comprise at least one folded portion and stitches extending through the folded portion to form a radially protruding rib.
A clip may be configured to close the portion of the heart, to reduce blood flow therethrough as well as passage of clots or other undesired materials. The clip may be configured to close the left atrial appendage (LAA). The closure of the LAA may reduce the possibility of stroke or other maladies stemming from fluid flow with the LAA.
A61B 17/128 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets pour ligaturer ou comprimer par un autre moyen les parties tubulaires du corps, p.ex. les vaisseaux sanguins ou le cordon ombilical pour appliquer ou enlever les clamps ou les pinces
Systems, devices, and methods for the automated tying of knots as part of a suturing process for a target device, such as a prosthetic heart valve. The automated knot tying systems automatically tie two free ends of thread or sutures on a heart valve into a knot. The automated knot tying systems include fixtures whose coordinated movement result in tying one or more knots in sutures. The automated knot tying systems can be used with wet or dry tissue on a prosthetic heart valve. The automated knot tying systems can be configured to tie a variety of knots including overhand knots, double overhand knots, square knots, double square knots, etc.
The present disclosure relates to devices designed to aid in accurate positioning and deployment of prosthetic valves inside a native annulus. In an example, a delivery assembly comprises a prosthetic valve comprising a frame movable between radially compressed and expanded configurations, and a delivery apparatus. The delivery apparatus includes an outer delivery shaft, and at least one elongated positioning member extending through, and axially movable relative to, the outer delivery shaft. The elongated positioning member is configured to position a distal end thereof radially outward to the prosthetic valve and axially distal to an outflow end of the frame. In some examples, the delivery apparatus can further include at least one sensor attached to the elongated positioning member.
Disclosed herein are inflators and methods of using the inflators for inflating inflatable devices, such as balloons, used in medical procedures. Such procedures include angioplasty and the transcatheter delivery of prosthetic heart valves and stents. The inflators overcome the resistances typically generated during such procedures and reduces the force required to fully inflate the balloon.
A61F 2/958 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes ballons gonflables pour insérer les stents ou les endoprothèses déployables couvertes
A61M 5/315 - Pistons; Tiges de piston; Guidage, blocage, ou limitation des mouvements de la tige; Accessoires disposés sur la tige pour faciliter le dosage
An expandable delivery sheath includes an elastic outer tubular layer and an inner tubular layer. The inner tubular layer includes a thick wall portion integrally connected to a thin wall portion. The thin wall portion can include longitudinal reinforcing members/rods that facilitate unfolding during the passage of the implant, thus decreasing the push force and increasing the consistency of the push force. The inner tubular layer can have a non-expanded or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the non-expanded condition with the sheath reassuming its smaller profile.
A61F 2/958 - Instruments spécialement adaptés pour insérer ou retirer les stents ou les endoprothèses déployables couvertes ballons gonflables pour insérer les stents ou les endoprothèses déployables couvertes
The present invention relates to systems, assemblies and methods for detecting detachment of a prosthetic valve actuator. In an example, a prosthetic valve actuator detachment detection system comprises at least one actuator, a frame of the prosthetic valve movable by the at least one actuator between a radially compressed configuration and a radially expanded configuration, and at least one mechanical wave sensor.
The present disclosure relates prosthetic valves and assemblies that include an outer skirt releasably coupled to the frame or to another skirt of the prosthetic valve. In an example, a prosthetic valve assembly includes a prosthetic valve comprising an annular frame and a first skirt attached to the frame, and a second skirt disposed radially outward to the first skirt and releasable coupled to the first skirt via at least one retaining suture attached to the frame and extending through inflow and outflow loops of the first and second skirts. The second skirt is configured to be released from the first skirt upon withdrawal of the at least one retaining suture from the inflow and outflow7 loops of both skirts.
