A delivery apparatus configured to deliver a prosthetic valve can include a handle, a first shaft extending distally from the handle, a second shaft extending through a lumen of the first shaft, a nose cone mounted on a distal end portion of the second shaft, a balloon mounted along the distal end portion of the second shaft, and a first pull wire extending longitudinally along the second shaft. A distal end of the first pull wire is fixed relative to the second shaft at a location that is distal to a distal end of the balloon. Tension in the first pull wire can be adjusted to adjust a curvature of the distal end portion of the second shaft and the nose cone.
A sealing member for an implantable prosthesis includes a substrate comprising a substrate material, and one or more hydrogel structures disposed on an outwardly facing surface of the substrate. The hydrogel is stimulus responsive, and undergoes a change in volume, stiffness, or both when exposed to the stimulus. The sealing member promotes endothelialization and/or reduces paravalvular leakage.
A61L 27/18 - Matériaux macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone
A61L 27/26 - Mélanges de matériaux macromoléculaires
An implantable prosthetic device can include a radially expandable and compressible annular frame comprising an inflow end portion and an outflow end portion, and a plurality of leaflets arranged within the frame. Each leaflet can include one or more commissure tabs. The commissure tabs of two adjacent leaflets coupled to a commissure attachment member to form a commissure. The commissure can be secured to the frame via first and second sutures, each suture extending through a respective commissure tab, through the commissure attachment member, crossing over the other suture and being secured to the frame. The commissure can define a bending axis disposed radially inwardly of the frame such that a main body of each leaflet is prevented from contacting the frame when the valvular structure is in an open configuration.
A method of treating a tricuspid valve that defines an annulus between a right atrium and a right ventricle of the heart is described. A first anchor and a second anchor are transluminally advanced to the heart. The first anchor is anchored inside a coronary sinus of the heart. The second anchor is anchored, from the right atrium, at a site that is across the annulus from the coronary sinus by driving a distal portion of the second anchor into the annulus at the site. Subsequently, a distance between the first and second anchors is reduced by applying tension to a tensioning member coupled to the first and second anchors. The tension is maintained by locking a lock member to the tensioning member. Other embodiments are also described.
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
5.
HEART VALVE REPAIR DEVICES AND DELIVERY DEVICES THEREFOR
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 include a pair of paddles frame a coaptation element. The coaptation element defines a first area when viewed from above. The paddle frames define when viewed from above. A ratio of the second area to the first area is greater than or equal to 2 to 1.
Apparatus, for use at a valve of a heart of a subject, includes a first catheter, a second catheter, and a translation element. The translation element is connected to, and operatively joins, the distal ends of the first catheter and the second catheter. The translation element is operable to translate the distal ends laterally with respect to each other to transition the apparatus between (i) a first state in which the distal ends are held next to each other for transluminal advancement to the heart, and (ii) a second state in which the distal ends are spaced apart from each other for positioning at a first location on the annulus and a second location on the annulus, respectively. The apparatus is configured to, while in the second state, from the distal ends, anchor a first tissue anchor at the first location, and a second tissue anchor at the second location.
Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with a tubular inner liner wound in a spiral configuration such that a plurality of protrusions is disposed in an overlapping portion of the sheath. The disclosed sheath is configured to expand from a predetermined rest diameter dr to an expanded diameter de during application of a radial outward force by passage of a medical device through the sheath.
Devices, systems, and/or methods can provide compliance characteristics to fluid vessels. For example, an implant device can include an anchoring structure to anchor the implant device to a blood vessel, heart valve, or other anatomy. The anchoring structure can be coupled to an elastic tube that is configured to expand. The elastic tube can include a prosthetic valve to permit fluid to flow through the implant device.
Devices, systems, and/or methods discussed herein relate to medical device packaging that includes various features for packaging a medical device and/or preparing the medical device for use in a procedure. For example, packaging can include features to retain a medical device during distribution, such as foldable ends that are configured to cover the medical device. Further, the packaging can include features that are configurable to elevate one end of packaging to assist in preparing the medical device for a procedure, such as to flush the medical device in an elevated state. Moreover, the packaging can include features to hold and/or dispose of a fluid in an efficient manner.
A61B 50/20 - Récipients, étuis, mobilier ou supports spécialement adaptés aux appareils ou aux instruments chirurgicaux ou de diagnostic, p.ex. étuis stériles Équipements de support spécialement adaptés aux appareils ou aux instruments chirurgicaux ou de diagnostic
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
A compliance-restoration system comprises an implant configured to be inflated with a fluid, the implant having a proximal portion and a distal portion, the proximal portion and the distal portion configured to expand in width in response to receiving fluid, wherein the distal portion is configured to inflate with the fluid in response to deflation of the proximal portion.
A61F 2/915 - Stents ayant une forme caractérisée par des éléments filiformes; Stents ayant une forme caractérisée par une structure de type filet ou de type à mailles caractérisés par une structure de type filet ou de type à mailles fabriquée à partir de feuilles perforées ou de tubes perforés, p.ex. perforés par découpe au laser ou gravés avec des bandes présentant une structure en méandre, des bandes adjacentes étant reliées l’une à l’autre
A cardiac implant comprises a frame forming an inner lumen and configured for delivery into a blood vessel and a covering extending at least partially along the frame.
A61F 2/915 - Stents ayant une forme caractérisée par des éléments filiformes; Stents ayant une forme caractérisée par une structure de type filet ou de type à mailles caractérisés par une structure de type filet ou de type à mailles fabriquée à partir de feuilles perforées ou de tubes perforés, p.ex. perforés par découpe au laser ou gravés avec des bandes présentant une structure en méandre, des bandes adjacentes étant reliées l’une à l’autre
An automated system that can be used for prosthetic heart valve manufacturing or suturing procedures. The system can include a first automated fixture that includes an articulating arm and a target device holder. The system can also include one or more additional automated fixtures, which can be configured as one or more suturing arms that include another articulating arm and a needle holder. The first automated fixture can be configured to rotate a target device held by the holder to allow the one or more additional automated fixtures to perform operations such as form sutures on the target device without intervention of a human operator. The system can include a display system configured to display status information of a suturing procedure.
C07K 16/20 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains provenant de protozoaires
C07K 16/44 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel non prévu ailleurs
A volume indicator for a syringe can include an indicator body configured to removably clip onto a syringe body and a window portion extending through a thickness of the indicator body. The volume indicator can include inflation indicia corresponding to a range of expanded diameters for a prosthetic heart valve. The volume indicator can include one or more first engagement elements that correspond to one or more second engagement elements on a syringe.
An implantable prosthetic valve can comprise an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end, a leaflet structure positioned within the frame and secured thereto, and an outer sealing member positioned around an outer surface of the frame, wherein the outer sealing member comprises a plurality of sealing segments, wherein each sealing segment is coupled to the frame and/or another sealing segment by a tether that pulls a portion of the sealing segment in a circumferential direction when the frame is radially expanded to the expanded configuration.
A right ventricular assist device (hereinafter "RVAD") for placement inside a mammalian subject includes a tube having an inlet configured to be positioned in the mammalian subject when the tube is in a proper position within a heart and an outlet configured to be located in a pulmonary artery when the tube is in the proper position. The RVAD also includes a plurality of sensors having measurement locations along the tube to measure a plurality of pressures of blood exterior to the tube at the measurement locations and a controller in communication with the pump and the plurality of sensors that convey the plurality of pressures to the controller with the controller being configured to instruct the pump to pump blood through the tube depending on at least one of the plurality of pressures.
A61M 1/36 - Autre traitement du sang dans une dérivation du système circulatoire naturel, p.ex. adaptation de la température, irradiation
A61M 60/117 - Pompes extracorporelles, c.-à-d. que le sang est pompé à l’extérieur du corps du patient pour aider le cœur, p.ex. dans les dispositifs transcutanés ou d’assistance ventriculaire externe
A61M 60/13 - 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 au moyen d’un cathéter permettant l’explantation, p.ex. pompes à cathéter temporairement introduites par le système vasculaire
A61M 60/17 - 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 à l’intérieur d’un ventricule, p.ex. pompes à ballon intra-ventriculaires
A61M 60/174 - 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 à l’intérieur d’un ventricule, p.ex. pompes à ballon intra-ventriculaires refoulant le sang vers le ventricule ou le système artériel par une canule interne au ventricule ou au système artériel
A61M 60/861 - Connexions ou ancrages pour connecter ou ancrer les pompes ou dispositifs de pompage à des parties du corps du patient
A61M 60/867 - Dispositifs de guidage ou d’insertion de pompes ou dispositifs de pompage à l’intérieur du corps du patient utilisant la détection de la position pendant le déploiement, p.ex. pour les pompes pour le sang montées sur un cathéter et entraînées à travers celui-ci
The expandable sheath and methods of use disclosed herein are used to deliver a prosthetic device through a patient's vasculature. The sheath is constructed to be expandable in the circumferential direction, while maintaining sufficient stiffness in the longitudinal direction to withstand pushing and resist kinking. The sheath includes a plurality of curved arms extending outwardly from a longitudinally extending spine. The curved arms move away from the longitudinal axis of the sheath when pushed radially outwardly by a passing prosthetic device, and move back toward the longitudinal axis once the prosthetic device has passed.
A catheter assembly comprises a catheter, a handle, disposed at a proximal part of the catheter, a pull wire, extending from a distal part of the catheter, proximally through the catheter to the handle, and a control handle assembly, disposed at the handle, and configured to be operated: (i) in a gross-tensioning manner that grossly adjusts tension on the pull wire, and (ii) in a fine-tensioning manner that finely adjusts the tension on the pull wire. Other embodiments are also described.
Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.
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
20.
SYSTEM AND METHOD FOR TRANSAORTIC DELIVERY OF A PROSTHETIC HEART VALVE
A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus via a transaortic approach. The system includes a balloon catheter for delivering a balloon-expandable prosthetic heart valve through an introducer from an approach from outside the patient, through a minimally-invasive opening in the chest cavity through an incision in the aorta, and into the aorta and aortic annulus. The balloon catheter includes a flexible, tapered tip just distal of the balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.
A steerable delivery apparatus for an implantable medical device comprises a shaft extending distally from the handle, the shaft having a steering-member lumen extending through a length of the shaft, and a steering member extending through the steering-member lumen, the steering member having a proximal end portion and a distal end portion. A pull ring is disposed along a distal end portion of the shaft, the pull ring comprising a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter. The distal end portion of the steering member is fixed to the distal segment of the pull ring, and an adjustment mechanism is further provided in the handle, the mechanism operatively coupled to the proximal end portion of the steering member and configured to adjust tension in the steering member so as to adjust a curvature of the shaft.
A contrast delivery system for determining tissue capture of a shunt device (1506) includes a catheter (1540) including a lumen having a distal end, an exit hole connecting the lumen to an exterior surface of the catheter, and a side opening adjacent to the distal end of the lumen. The contrast delivery system further includes a tube (1542) slidably receivable in the lumen and configured to deliver a contrast agent, the tube including a closed distal terminal end, a first distal hole (1546A), and a proximal hole (1548). The first distal hole and proximal hole are spaced along a length of the tube, wherein the first distal hole is disposed between the proximal hole and the closed distal terminal end. The tube is configured to slide in the lumen between a plurality of positions.
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
A61M 31/00 - Dispositifs pour l'introduction ou la rétention d'agents, p.ex. de remèdes, dans les cavités du corps
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
A61B 17/22 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets pour l'élimination non prévue ailleurs des obstructions dans les vaisseaux sanguins
A delivery device for delivering a shunt device within a human body, the delivery device includes a nosecone including a straight portion and a tapered portion, and a molded bridge coupled to the nosecone. The molded bridge includes a body, a notch extending into the body of the molded bridge, and a pocket extending into the body of the molded bridge. The pocket is positioned on an opposite side of the molded bridge as the notch. The molded bridge further includes a plurality of lumens positioned within and extending at least partially through the body of the molded bridge.
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
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
A61B 17/20 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets pour la vaccination ou le nettoyage de la peau avant la vaccination
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
A61M 5/00 - Dispositifs pour faire pénétrer des agents dans le corps par introduction sous-cutanée, intravasculaire ou intramusculaire; Accessoires à cet effet, p.ex. dispositifs de remplissage ou de nettoyage, appuis-bras
24.
CIRCULATION MANAGEMENT THROUGH BLOOD VESSEL REMODELING
An implant device includes an elongated stent structure forming an axial flow channel therethrough. The stent structure has a shape-memory that biases the stent structure to a bent configuration, such that the stent structure is configured to return to the bent configuration after manipulation to a straightened configuration of the stent structure.
A61F 2/90 - Stents ayant une forme caractérisée par des éléments filiformes; Stents ayant une forme caractérisée par une structure de type filet ou de type à mailles caractérisés par une structure de type filet ou de type à mailles
25.
COMPRESSIBLE-GAS-FILLED IMPLANT WITH LIQUID BUFFER
An implant device includes a first chamber containing a compressible gas medium and a second chamber separated from the first chamber by a first membrane portion, the second chamber containing an at least partially liquid medium.
A system for regulating blood flow through a blood vessel of a heart, the system comprising a valve comprising an outer frame and configured for placement at least partially within the blood vessel.
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 60/531 - Régulation par des données du patient en temps réel par des données de tension artérielle, p.ex. provenant de capteurs de tension
A61M 60/861 - 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
A61M 60/90 - Pompes pour le sang; Dispositifs pour l'actionnement mécanique de la circulation; Pompes à ballon d’assistance circulatoire - Détails non prévus dans les groupes , ou
A prosthetic heart valve includes an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The frame has a plurality of circumferentially extending rows of angled struts, each row of angled struts comprising angled struts arranged in a zig-zag pattern. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame. The sealing member has an undulating outflow edge portion forming a plurality of triangular projections that are connected to and shaped to correspond to the zig-zag pattern of one of the rows of angled struts. The outer sealing member is sized to fit snugly against the outer surface of the frame when the frame is in the expanded configuration.
A device for delivering a shunt device within a human body, the shunt device having a central flow tube, a proximal arm, and a distal arm, the proximal arm and distal arm configured to capture a tissue wall therebetween. The delivery device includes a catheter that includes a tube and a side opening. The delivery device further includes a flexible wire slidably receivable in the tube and extendable into the side opening. The flexible wire includes a tip at a distal end configured to deflect upon contact with human tissue. The flexible wire is disposed outside of the central flow tube of 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
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
A61M 5/00 - Dispositifs pour faire pénétrer des agents dans le corps par introduction sous-cutanée, intravasculaire ou intramusculaire; Accessoires à cet effet, p.ex. dispositifs de remplissage ou de nettoyage, appuis-bras
29.
CURVED OUTER SHEATH FOR A SHUNT DEVICE DELIVERY DEVICE
An outer sheath for surrounding and covering components of a delivery device includes a straight section including an aperture extending fully through the straight section. The outer sheath further includes a pre-curved section extending distally from an end of the straight section and including an aperture extending fully through the pre-curved section. The straight section and the pre-curved section include a varying stiffness along a length of the straight section and the pre-curved section.
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
A delivery device for implanting a shunt device in a tissue wall includes an actuation arm extending through the delivery device, the actuation arm configured to seat an arm of the shunt device on the tissue wall, and a wavy release wire extending through the actuation arm, wherein the wavy release wire includes a wavy portion that forms a friction fit with the actuation arm.
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
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
A61M 5/00 - Dispositifs pour faire pénétrer des agents dans le corps par introduction sous-cutanée, intravasculaire ou intramusculaire; Accessoires à cet effet, p.ex. dispositifs de remplissage ou de nettoyage, appuis-bras
A shunt device is configured to be inserted into a puncture in a tissue wall that defines a horizontal reference plane. The shunt device includes a shunt body. The shunt body includes a central flow tube extending from a first axial end to a second axial end and defining a central axis therethrough that is angled from a reference axis extending perpendicular through the horizontal reference plane; a flow path extending through the central flow tube; and a plurality of arms extending outward from the central flow tube and configured to secure the shunt device to the tissue wall. The plurality of arms includes a first distal arm and a second distal arm attached to the first axial end of the central flow tube and a first proximal arm and a second proximal arm attached to the second axial end of the central flow tube.
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
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
A61M 5/00 - Dispositifs pour faire pénétrer des agents dans le corps par introduction sous-cutanée, intravasculaire ou intramusculaire; Accessoires à cet effet, p.ex. dispositifs de remplissage ou de nettoyage, appuis-bras
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
32.
SYSTEMS AND METHODS FOR RESPONSIVE DAMPING OF PRESSURE
Systems and methods for responsively damping pressure pulsations are provided. Generally, a responsive damping system can comprise one or more responsive dampeners, responsive dampeners can include a means for damping pressure pulsations via a pressure resistor.
Methods and systems for attaching a radiopaque marker to a prosthetic heart valve to indicate a location of a commissure of the prosthetic heart valve are disclosed. As one example, a prosthetic heart valve includes a frame including a plurality of struts forming a plurality of cells of the frame arranged between an inflow end and an outflow end of the frame, a plurality of leaflets arranged within the frame, and at least one commissure comprising an attachment member arranged across a selected cell of the plurality of cells of the frame and commissure tabs of two adjacent leaflets coupled to the attachment member. The valve further includes a radiopaque marker arranged on the attachment member of the commissure within the selected cell.
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
A sheath assembly can comprise a removable hub. The removable hub can have a lumen extending therethrough and comprise a first circumferential hub portion that spans a first circumferential segment about a longitudinal axis of the removable hub, a second circumferential hub portion that spans a second circumferential segment about the longitudinal axis of the removable hub, and first and second connector portions connecting the first circumferential hub portion and the second circumferential hub portion. The second circumferential segment can be greater than the first circumferential segment. The sheath assembly can comprise a removable shaft configured to extend distally from a distal end of the removable hub, the removable shaft being configured such that separation of the first circumferential hub portion from the second circumferential hub portion causes a first circumferential shaft portion to separate from a second circumferential shaft portion.
A61M 60/865 - Dispositifs de guidage ou d’insertion de pompes ou dispositifs de pompage à l’intérieur du corps du patient
A61M 60/148 - 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 en ligne avec un vaisseau sanguin par résection ou techniques analogues, p.ex. dispositifs permanents d’assistance cardiaque endovasculaire
36.
INTRAVASCULAR CATHETER TO MEASURE VESSEL DISTENSIBILITY, COMPLIANCE, AND PULSE WAVE VELOCITY
The devices and methods disclosed herein relate to providing an accurate and direct measure of vessel distensibility. These direct measures can also simultaneously record invasive pressures and provide a precise PWV calculation. The disclosed devices include a catheter that is easily inserted under fluoroscopic guidance through the femoral or radial artery. The disclosed devices enable physicians to diagnose aortic stiffness and to provide a direct measure of aortic compliance.
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 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
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
37.
EXPANDABLE PROSTHETIC HEART VALVE FRAME WITH LEAFLET SUPPORT STRUTS
A prosthetic heart valve including a radially expandable and compressible annular frame and a plurality of leaflets attached to the frame is disclosed. The frame includes a plurality of interconnected struts defining a plurality of rows of cells arranged between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end of the frame. The frame further includes a plurality of second struts axially offset from the first end of the frame, each second strut connected to and between two adjacent first struts of the plurality of first struts and extending axially away from the two adjacent first struts, where an inflow end of a cusp edge portion of each leaflet of the plurality of leaflets is secured to a corresponding second strut of the plurality of second struts.
Delivery apparatus and methods for delivering a medical device into a patient's vasculature are disclosed. In some examples, a method includes inserting, into a patient, a distal end portion of a delivery apparatus including a radially compressed prosthetic valve mounted around a balloon, advancing the distal end through the patient's vasculature, and inflating the balloon to radially expand the prosthetic valve at a native heart valve. The delivery apparatus includes a handle, a first shaft and a second shaft extending from the handle, and a locking mechanism to prevent axial movement of the second shaft relative to first shaft. The second shaft extends coaxially through the first shaft and includes the balloon, the radially compressed prosthetic valve, and one or more radiopaque markers at a distal end portion. The first shaft includes an end piece covering a proximal portion of the balloon during the advancing of the delivery apparatus.
A method and system for non-invasively determining continuous total hemoglobin data is provided. The method includes a) using a near infra-red spectrophotometric (NIRS) sensing device on a continuous basis to sense a subject's tissue, the sensing producing NIRS signals; and b) determining continuous total hemoglobin (THb) using the produced NIRS signals.
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
G01N 21/359 - Couleur; Propriétés spectrales, c. à d. comparaison de l'effet du matériau sur la lumière pour plusieurs longueurs d'ondes ou plusieurs bandes de longueurs d'ondes différentes en recherchant l'effet relatif du matériau pour les longueurs d'ondes caractéristiques d'éléments ou de molécules spécifiques, p.ex. spectrométrie d'absorption atomique en utilisant la lumière infrarouge en utilisant la lumière de l'infrarouge proche
An implant device comprises a stent frame having an oval cross-sectional shape and a fluid-tight covering disposed on a portion of the stent frame. Such implant devices can include a first end portion having a circular cross-sectional shape and a medial portion having a non-circular cross-sectional shape.
A61F 2/915 - Stents ayant une forme caractérisée par des éléments filiformes; Stents ayant une forme caractérisée par une structure de type filet ou de type à mailles caractérisés par une structure de type filet ou de type à mailles fabriquée à partir de feuilles perforées ou de tubes perforés, p.ex. perforés par découpe au laser ou gravés avec des bandes présentant une structure en méandre, des bandes adjacentes étant reliées l’une à l’autre
An aperture valve for maintaining hemostasis extends from a proximal end to a distal end along a primary axis. The aperture valve includes a proximal ring situated at the proximal end and formed of rigid material, a distal ring situated at the distal end and formed of rigid material, a flexible cylinder surrounding the primary axis, attached to and axially overlapping with the proximal ring and the distal ring, and a locking mechanism selectively anchoring the proximal ring to the distal ring. The flexible cylinder is irisable by rotation of the proximal ring relative to the distal ring. The locking mechanism is engageable to retain the flexible cylinder in an irised state by locking the proximal ring to the distal ring while the proximal ring is rotated relative to the distal ring.
Several heart wall remodeling devices and methods are disclosed. One heart wall remodeling device includes a trimming tool for trimming a line within a patient. The trimming tool includes an actuator for manipulation by a user, a moveable inner shaft coupled to the actuator, and an outer sleeve coupled to the inner shaft. The outer shaft includes a backstop disposed along an inner wall of the outer sleeve and a channel disposed between a first end and a second end of the outer sleeve. The inner shaft includes an inner shaft, a compressible member, and a cutter.
Systems, apparatuses, and methods disclosed herein are provided for medical treatment, including treatment of dilated hearts (e.g., dilated left ventricle) or functional mitral valve regurgitation within a human heart. In examples, transcatheter medical treatments may be utilized. The portion of the patient's heart may be dilated due to a myocardial infarction or other cardiomyopathy. The treatment may comprise beating-heart repair of left ventricles with ischemic or non-ischemic dilated cardiomyopathy. The treatments may include approximating papillary muscles of the heart and accommodating ventricular expansion of the heart.
In one embodiment, a delivery apparatus handle, such as for a mechanical heart valve frame can comprise an actuation knob with a toggle mechanism that can toggle the actuation knob from a first state in which the actuation knob is operable to cause the linear or rotational movement of multiple elements or sets of elements, such as tubes that are attached to, e.g., a mechanical heart valve frame to cause expansion or collapsing of the frame, to a second state in which only a single element or set of elements is moved, allowing for additional operations, such as, e.g., locking the frame and/or releasing it from the delivery apparatus.
A prosthetic valve, constituted of: a frame movable between a radially compressed and a radially expanded state; and a plurality of leaflets secured to the frame.
Various systems, devices, and methods are described herein pertaining to expandable sheaths. Sheath aspects are described that include a flexible sheath tip that is expandable and bendable. In some aspects, the sheath includes a radially expandable proximal end and a radially expandable distal end. In some aspects, the sheath tip includes a plurality of layers that expand to accept a medical device traveling axially and bi-directionally therethrough with minimal deformation of the sheath tip.
Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with a tubular inner liner wound in a helical scroll slidable configuration. The disclosed sheath is configured to expand from a predetermined rest diameter dr to an expanded diameter de during the application of a radial outward force by passage of a medical device through the sheath.
Devices, assemblies, and methods for displacement of leaflets surrounding a prosthetic valve, such as native leaflets or host leaflets of a previously-implanted prosthetic valve, during valve implantation procedures are disclosed herein. As one example, a valve assembly can include a prosthetic valve and a leaflet engagement frame coupled to the frame of the prosthetic valve. The leaflet engagement frame can include a plurality of engagement frame struts defining one or more rungs, and a plurality of spikes that extend in a distal direction from a first rung of struts of the leaflet engagement frame. The distally extending spikes are configured to engage with one or more native or host leaflets positioned outside the valve assembly when the valve assembly is in a partially expanded state, and to distally fold the engaged native or host leaflets when the valve assembly is further expanded.
A method for retrieving a previously inserted prosthetic valve is disclosed. In one example, a loader assembly is inserted through a hub of a delivery sheath device. The delivery sheath device includes an expandable sheath that extends into a blood vessel of a patient. The loader assembly is advanced in a distal direction until a distal section of the loader assembly extends into the expandable sheath which is attached to a distal end of the hub. The distal section has a larger inner diameter than a middle tube section of the loader assembly. A delivery catheter is retracted to move a prosthetic valve attached thereto in a proximal direction until the prosthetic valve is received within the distal section. The loader assembly and the delivery catheter are removed from a proximal end of the hub while the prosthetic valve is retained within the distal section.
In one embodiment, a multi-layer suture fastener that includes a generally disc-shaped body defining a plurality of axially spaced-apart layers. Each layer can include an inner axial surface and an outer axial surface. A suture opening can extend from the inner axial surface to the outer axial surface of each layer. The suture openings can have an open configuration and a closed configuration. One or more lines of suture can be passed through the suture openings when in the open configuration. The suture openings can be placed in the closed configuration. In the closed configuration, the one or more lines of suture can be restricted by radial surfaces of the suture opening from sliding through the suture openings in at least one longitudinal direction of the one or more lines of suture.
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
A delivery apparatus for a medical device can include a handle, a shaft, a plurality of sleeves, and a suture. The shaft includes a proximal end portion coupled to the handle and is configured to be disposed outside of a patient's body during an implantation procedure and a distal end portion configured to be disposed inside a patient's body during the implantation procedure. Each of the sleeves includes a connection portion coupled to the distal end portion of the shaft and a receiving portion configured to receive an apex of a stent or a prosthetic heart valve. The suture extends through the shaft and the sleeves and is configured for releasably securing the stent or the prosthetic heart valve to the receiving portions of the sleeves.
A method of preparing a ventricular partitioning device for implantation using a delivery system can include coupling the ventricular partitioning device to a delivery catheter, loading the ventricular partitioning device and a portion of the delivery catheter into a sleeve and creating a liquid-tight seal between a portion of the sleeve and the delivery catheter, coupling a distal end of the sleeve to a guide catheter, and delivering fluid through at least one of the first fluid delivery port or the second fluid delivery port. The method can be performed with the delivery catheter or the sleeve having a first fluid delivery port positioned thereon. The method can be with the guide catheter having a second fluid delivery port positioned thereon.
A61B 17/12 - 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
56.
EXPANDABLE SHEATH FOR INTRODUCING AN ENDOVASCULAR DELIVERY DEVICE INTO A BODY
Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with a tubular inner liner wound in a spiral configuration at least a portion of the outer surface of the sheet comprises a plurality of bonding sites that are at least partially embedded within the sheet and disposed such that the outer surface of the sheet in the overlapping portion is substantially free of the plurality of bonding sites.
A delivery apparatus for a prosthetic heart valve includes a shaft, an inner balloon, and an outer balloon. The shaft has a lumen extending from a proximal end portion to a distal end portion and a plurality of openings formed in the distal end portion. The shaft is configured such that a fluid can flow through the lumen and the openings. The inner balloon has end portions and a center portion disposed between the end portions. The inner balloon is mounted on the distal end portion of the shaft and is in fluid communication with the openings of the shaft. When the inner balloon is inflated with the fluid, the end portions expand farther radially outwardly than the center portion. The outer balloon is mounted to the shaft and disposed over the inner balloon. The outer balloon is configured to fully expand after the inner balloon at least partially expands.
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 method comprises delivering a first implant to an orifice of a chamber of a heart, anchoring the first implant at the orifice, delivering a sensor device to the orifice, and coupling the sensor device to the first implant.
A sensor implant system comprises a shunt implant comprising a central flow portion configured to maintain an opening through a tissue wall and a sensor implant device. The sensor implant device comprises a shunt body configured to fit at least partially within the central flow portion of the shunt implant and a sensor device coupled to the shunt body.
A system can include a prosthetic heart valve having a commissure post configured to receive a first portion of a fiber and a suture support configured to engage with the prosthetic heart valve. The suture support can include a first portion to interface with an inflow side of the prosthetic heart valve and a fiber holding portion to receive a second portion of the fiber. A second portion of the suture support can be coupled to the first portion of the suture guard and be movable inwardly toward the first portion of the suture guard to transform the fiber from a non-tensioned state to a tensioned state. The fiber in the tensioned state can cause the commissure post to bend inward toward a longitudinal axis of the prosthetic heart valve.
The present disclosure concerns embodiments of multi-lumen cannulae that can be used in various different medical procedures. The multi-lumen cannulae can comprise an elongated body comprising multiple different ports that connect to various different sidewall lumens contained within the elongated body. The multi-lumen cannulae can also comprise a central lumen that extends through the entire elongated body and can be fluidly connected to the various different sidewall lumens. The multi-lumen cannulae can further comprise two balloons on an exterior of the elongated body, which can be used to isolate a right atrium of a patient's heart.
A61M 1/36 - Autre traitement du sang dans une dérivation du système circulatoire naturel, p.ex. adaptation de la température, irradiation
A61M 1/00 - Dispositifs de succion ou de pompage à usage médical; Dispositifs pour retirer, traiter ou transporter les liquides du corps; Systèmes de drainage
A61M 1/16 - Systèmes de dialyse; Reins artificiels; Oxygénateurs du sang avec membranes
Capsule loading assist apparatuses and associated methods. A capsule loading assist apparatus can comprise a lead screw, a loading assist nut, and a torque transfer mechanism. The loading nut comprises a capsule engagement surface configured to engage a delivery capsule of a delivery apparatus to exert a loading assist force on the delivery capsule. The capsule loading assist apparatus is configured such that rotating the lead screw in a first lead screw direction causes the loading assist nut to move along the lead screw in a distal direction. A capsule loading assist assembly can comprise a delivery apparatus, a prosthetic heart valve, and a capsule loading assist apparatus. A method can comprise operatively coupling a delivery apparatus to a capsule loading assist apparatus with a loading assist nut and rotating a capsule translation knob of the delivery apparatus to translate the loading assist nut in a distal direction.
A hemodynamic monitor includes a non-invasive blood pressure sensor and an integrated hardware unit with a system processor, a system memory, and a display with a user interface. The system memory includes instructions that are configured to: adjust, by a pressure controller, a pressure within an inflatable blood pressure bladder to maintain a constant volume of an artery of a patient for a period of time; generate an arterial pressure waveform data of the patient based on the adjusted pressure within the inflatable blood pressure bladder over the period of time; extract a plurality of signal measures from the arterial pressure waveform data of the patient; extract input features from the plurality of signal measures that are indicative of an ejection fraction score of the patient; and determine the ejection fraction score of the patient based on the extracted input features.
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 5/0225 - 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 la pression étant commandée par des signaux électriques, p.ex. dérivés des bruits de Korotkoff
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
A61B 5/0215 - Mesure de la pression dans le cœur ou dans les vaisseaux sanguins par des moyens introduits dans le corps
A method for treating heart failure comprises delivering an implant into a pericardial cavity of a heart using a delivery system, inflating the implant with a filling to expand the implant, and releasing the implant from the delivery system.
Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.
An implantable prosthetic device can include a hybrid frame movable between a radially compressed configuration and a radially expanded configuration. The hybrid frame can include a mechanically-expandable first sub-frame comprising a plurality of struts pivotably coupled to one another, and a plastically deformable second sub-frame coupled to the first sub-frame. When the hybrid frame is in the expanded configuration, the second sub-frame can be configured to resist radial compression of the frame.
A hemodynamic monitor for detecting aortic stenosis includes a non-invasive blood pressure sensor and an integrated hardware unit with a system processor, a system memory, and a display with a user interface. The system memory includes instructions that, when executed by the system processor, are configured to adjust, by a pressure controller, a pressure within an inflatable blood pressure bladder. An arterial pressure waveform data of the patient is generated based on the adjusted pressure within the inflatable blood pressure bladder over the period of time and a plurality of signal measures are extracted from the arterial pressure waveform data of the patient. Input features are extracted from the plurality of signal measures that are indicative of an aortic stenosis score of the patient, and the aortic stenosis score of the patient is determined based on the extracted input features.
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
A61B 5/0225 - 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 la pression étant commandée par des signaux électriques, p.ex. dérivés des bruits de Korotkoff
A61B 5/0215 - Mesure de la pression dans le cœur ou dans les vaisseaux sanguins par des moyens introduits dans le corps
A61B 5/021 - Mesure de la pression dans le cœur ou dans les vaisseaux sanguins
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
70.
HEART VALVE SEALING DEVICES AND DELIVERY DEVICES THEREFOR
A valve repair devices and systems for repairing a native valve of a patient include a spacer, a plurality of paddles, and a plurality of moveable clasp arms. The plurality of moveable clasp arms are disposed between the plurality of paddles and the spacer. The moveable clasp arms are configured to attach to leaflets of a heart valve.
A61B 17/00 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets
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
A sensor implant device includes a sensor device, an anchor base structure secured to the sensor device, a first helical tissue anchor secured to at least one of the sensor device or the anchor base structure, the first helical tissue anchor winding in a first direction, and a second helical tissue anchor secured to at least one of the sensor device or the anchor base structure, the second helical tissue anchor winding in a second direction opposite the first direction.
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
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
72.
MECHANICALLY-EXPANDABLE PROSTHETIC HEART VALVES, DELIVERY APPARATUS, AND METHODS
Various examples of prosthetic heart valves, delivery apparatus, and methods of using such are disclosed herein. The prosthetic heart valves comprise frames that are movable between a radially-compressed configuration and one or more radially-expanded configurations. The frames of the prosthetic heart valves include actuation members and locking mechanisms configured to secure the frame in one or more radially-expanded configurations. In some examples, the actuation members and locking members are integrally formed with the frame. The frames of the prosthetic heart valves can be coupled to one or more shafts of a delivery apparatus via a threaded connection or a non-threaded connection.
Apparatus for repairing a leaflet of a heart valve can include a leaflet-plicating tool that can include leaflet-capture arms and a helical needle. The needle can be operatively coupled to the leaflet-capture arms. The leaflet-capture arms can include an arm-shaft, each configured to house a leaflet-engaging member. The leaflet-capture arms can be configured to use the leaflet-engaging members, extended over the leaflet from the annulus toward a free edge of the leaflet, to form a plication in the leaflet of the heart valve between the leaflet-capture arms. The leaflet-plicating tool can be configured to secure the plication by using the helical needle to stitch a suture helically along the plication. Other embodiments are also described.
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
74.
PROSTHETIC VALVE WITH EXPANDABLE FRAME AND ASSOCIATED SYSTEMS AND METHODS
Aspects of the disclosure relate to prosthetic valves having a frame, a frame cover, and a leaflet construct. Some aspects are directed to a diametric taper for the prosthetic valve for achieving enhanced performance of the prosthetic valve under operational conditions, enhanced compressibility and delivery characteristics, and other additional or alternative advantages. Other aspects are directed toward unique assembly and attachment methods for securing leaflet constructs to support structures. Other aspects are directed toward features for interacting with transcatheter delivery systems. Still other aspects are directed to such apparatuses, systems, and methods for valve replacement, such as cardiac valve replacement.
An implant includes a frame, and a textile mounted on the frame. The textile includes fibers formed from a mixture of a polymer and an additive molecule. The additive molecule includes a polyurethane backbone and one or more fluorinated end-groups at at least one end of the backbone. Other embodiments are also described.
A61L 17/10 - Matériaux au moins partiellement résorbables contenant des matériaux macromoléculaires
A61L 27/18 - Matériaux macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone
D01F 1/10 - Autres agents modifiant les propriétés de ces filaments
D01F 6/90 - Filaments, ou similaires, faits par l’homme, à un seul composant, formés de polymères synthétiques; Leur fabrication à partir de mélanges de produits de polycondensation comme constituant majeur avec d'autres polymères ou des composés de bas poids moléculaire de polyamides
D01F 6/92 - Filaments, ou similaires, faits par l’homme, à un seul composant, formés de polymères synthétiques; Leur fabrication à partir de mélanges de produits de polycondensation comme constituant majeur avec d'autres polymères ou des composés de bas poids moléculaire de polyesters
D01F 6/94 - Filaments, ou similaires, faits par l’homme, à un seul composant, formés de polymères synthétiques; Leur fabrication à partir de mélanges de produits de polycondensation comme constituant majeur avec d'autres polymères ou des composés de bas poids moléculaire d'autres produits de polycondensation
D02G 1/16 - Production de fibres, filaments, filés ou fils, crêpés ou ondulés ou leur donnant de telles caractéristiques latentes avec utilisation de jets ou de flux de gaz turbulents, p.ex. air, vapeur
D02G 3/44 - Filés ou fils caractérisés par la destination pour laquelle ils ont été conçus
D03D 1/00 - Tissus conçus pour faire des articles particuliers
D03D 15/283 - Tissus caractérisés par la matière, la structure ou les propriétés des fibres, des filaments, des filés, des fils ou des autres éléments utilisés en chaîne ou en trame caractérisés par la matière des fibres ou des filaments formant les filés ou les fils à base de polymères synthétiques, p.ex. fibres polyamides ou fibres polyesters
D04B 1/16 - Autres tricots ou articles caractérisés principalement par l'emploi de matières spéciales pour le fil fils synthétiques
D04B 1/18 - Autres tricots ou articles caractérisés principalement par l'emploi de matières spéciales pour le fil fils élastiques
D04B 21/16 - Tissus caractérisés par l'incorporation par tricotage de fils de renforcement, de fils de liage ou de fils décoratifs, dans un ou plusieurs fils, nappe ou couche de tissu; Tricots incorporant de petits éléments auxiliaires, p.ex. à des fins décoratives incorporant des fils synthétiques
D04B 21/18 - Tissus caractérisés par l'incorporation par tricotage de fils de renforcement, de fils de liage ou de fils décoratifs, dans un ou plusieurs fils, nappe ou couche de tissu; Tricots incorporant de petits éléments auxiliaires, p.ex. à des fins décoratives incorporant des fils élastiques
D04H 1/56 - Non-tissés formés uniquement ou principalement de fibres coupées ou autres fibres similaires relativement courtes à partir de voiles ou couches composés de fibres ne possédant pas des propriétés cohésives réelles ou potentielles par soudage des fibres ensembles, p.ex. par fusion partielle ou dissolution en association avec la formation de la fibre, p.ex. suivant immédiatement l'extrusion des fibres en brin
D04H 1/728 - Non-tissés formés uniquement ou principalement de fibres coupées ou autres fibres similaires relativement courtes caractérisés par la méthode de formation des voiles ou couches, p.ex. par la réorientation des fibres les fibres étant disposées au hasard par électrofilage
Embodiments of a catheter assembly are disclosed. The catheter assembly comprises a shaft; a connector assembly comprising a first connector portion and a second connector portion, wherein the first connector portion is fixedly coupled to a distal end of the shaft, and is rotatably coupled to the second connector portion by at least one radially extending pin retained within at least one slot on the second connector portion, wherein the at least one slot has an oversized circumferential dimension that allows limited rotation of the second connector portion relative to the first connector portion about a longitudinal axis of the shaft.
A sensor implant device comprises a sensor body, a sensor component, and one or more anchoring features coupled to the sensor body and configured to anchor within a blood flow pathway or left atrial appendage.
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
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 sensor implant device comprises a sensor body, at least a first sensor component, and one or more anchoring features coupled to the sensor device and configured to anchor within a tissue wall. The one or more anchoring features are configured to assume an unexpanded form during delivery and configured to expand into the tissue wall.
A61B 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
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 sensor implant system comprises a shunt body comprising a central flow portion configured for placement at least partially within an opening of a tissue wall and the sensor implant system comprises a sensor implant device comprising a sensor body. The sensor implant device is configured for placement within the opening of the tissue wall and between the central flow portion of the shunt body and an inner wall of the opening of the tissue wall.
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
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 steerable delivery system is provided for delivering a replacement heart valve to a native heart valve location. The steerable delivery system includes an outer sheath assembly having a capsule along a distal end portion for retaining the replacement heart valve in a compressed configuration. The capsule is constructed to provide both compression resistance and flexibility. The capsule may be formed with an outer polymer layer, a metal middle layer located on a radially inner surface of the outer polymer layer, and an inner liner located on a radially inner surface of the metal middle layer. A fluoroelastomer layer is provided for bonding the inner liner to the metal middle layer. The metal middle layer is preferably a metal hypotube.
A prosthetic heart valve includes a radially expandable and collapsible frame with an inflow end including a plurality of inflow apices and an outflow end including a plurality of outflow apices. A plurality of valve leaflets are positioned in the frame and configured to control blood flow through the prosthetic heart valve. A covering is disposed around the frame. The covering has an inflow end portion having an inflow edge and an outflow end portion having an outflow edge. The inflow end portion of the covering is disposed over the inflow apices of the frame such that the inflow edge of the covering is inside the frame. The outflow end portion of the covering is disposed over the outflow apices of the frame such that the outflow edge of the covering is inside the frame, and the covering covers an entire outer surface of the frame.
A prosthetic heart valve includes an outer frame, a cover, an inner frame, and a valve structure. The outer frame includes a main body and an atrial flange. The main body includes a plurality of struts forming a plurality of circumferential rows of cells, a plurality of rows of barbs extending from junctions of the struts, the atrial flange extending radially outwardly and in an atrial direction from the inflow end of the main body. The atrial flange includes an oval shape corresponding to a shape of the patient's native mitral valve anatomy. The cover is disposed on a radially inner side of the atrial flange and on a radially outer side of the atrial flange. The inner frame is disposed within the outer frame and has a cylindrical shape. The valve structure is coupled to the inner frame and includes a plurality of leaflets.
A method and apparatus for determining a subject's autoregulation function state is provided. The method includes: continuously sensing a tissue region of a subject with a tissue oximeter to produce first signals representative of at least one tissue oxygenation parameter during a period of time; continuously measuring a blood pressure level of the subject during the period of time to produce second signals representative of the subject's blood pressure during the period of time; determining a presence of a confounding factor that affects the sensed tissue oxygenation parameter in a manner independent of an autoregulation function of the subject, the determination using the first signals; using the first and second signals to determine an autoregulation function state of the subject when the absence of the confounding factor is determined. The method may include determining an at least one of an LLA or a ULA of a subject's autoregulation function state.
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
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
84.
SECURING A GUIDEWIRE DELIVERY CATHETER IN THE CORONARY SINUS USING A MECHANICALLY RELEASING ARM
Mechanisms are disclosed for securing a catheter in place to facilitate puncturing a hole through a vessel wall. The securing mechanisms include mechanically releasing arms that press against the wall of the vessel. The mechanically releasing arms are advanced out of the catheter. Outside of the catheter, the securing mechanisms angle or curve toward the vessel wall to contact the wall. The more the mechanically releasing arms are advanced, the closer the approach to the wall and the more force placed against the wall to anchor the catheter in place. The mechanically releasing arms include a plurality of wires that angle or curve toward the vessel wall when deployed, one or more wires that coil away from the catheter to contact the vessel wall when deployed, or a stopper arm with a curved endcap that contacts the vessel wall when deployed.
A delivery apparatus for a prosthetic valve comprises a handle body, and shaft displacement and shaft adjustment mechanisms coupled to the handle body. The shaft displacement mechanism is configured to axially displace a shaft relative to the handle body. The adjustment mechanism is configured to adjust a curvature of the shaft and comprises a pull wire coupled to a distal end of the shaft. A first knob is operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body. A second knob is operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.
A system for dry storage of a bioprosthetic heart valve comprising a valve housing and a storage tray. The valve housing has a cavity that is dimensioned to retain the heart valve and permits the addition of a hydrating liquid prior to implantation. A lid is pivotably movable between open position and a closed position to enclose the heart valve with in the valve housing. The valve housing cavity is dimensioned to inhibit rotational and lateral movement of the bioprosthetic heart valve. The valve housing nests within a storage tray and mating surfaces position the valve housing in a specific orientation and help resist rotational movement of the valve housing relative to the storage tray. The storage tray has a gas- permeable membrane and the valve housing features apertures to permit passage of a sterilizing gas.
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
Medical apparatus and instruments for monitoring of patients, including, sensors, cables, parts and fittings for the aforesaid goods; Medical and surgical apparatus and instruments for treating cardiovascular disease.
This disclosure is directed to prosthetic heart valves having expansion and locking assemblies. As one example, a prosthetic heart valve can include an annular frame and an expansion and locking assembly that is configured to radially expand the frame to a radially expanded state and/or to lock the prosthetic valve in the radially expanded state to prevent the prosthetic valve from collapsing (i.e., radially compressing). In some examples, the prosthetic heart valve can be configured to radially self-expand to a partially radially expanded state, and can then be further radially expanded to the radially expanded state and/or locked in the radially expanded state by pulling an actuator member of the expansion and locking assembly. In some examples, the actuator member can extend through openings in vertical struts of the frame.
Introducers that can be used in combination with sheaths for introducing a delivery apparatus into a patient's vasculature, and methods for utilizing such introducers, are disclosed herein. As one example, an introducer (100) can include a nosecone (130), and inner shaft (120) attached to the nosecone, and outer shaft (110) disposed around the inner shaft, and a plug (150) disposed around the inner shaft. The plug is configured to expand from a first diameter in a compacted configuration thereof, to a second diameter in an expanded configuration thereof.
Docking devices for securing a prosthetic valve at a native valve and delivery apparatus for delivery thereof. The docking device includes a coil member. A guard member includes a plurality of fibers that can extend radially outward from an exterior surface of the coil. The guard member can be secured to the coil via one or more sutures. The guard member can be compressed within a dock sleeve during delivery of the docking device to the native valve. The dock sleeve can be withdrawn or axially moved relative to the coil member to allow the guard member to transition from the compressed state to the radially extended state. The guard member can function anchor a prosthetic valve and limit or prevent paravalvular leakage when implanted in a native heart valve.
The present disclosure relates to prosthetic valves, and in particular, to prosthetic heart valves that include non-uniform valvular structures coupled to the frames of such valves, wherein the non-uniform valvular structures include soft or malleable movable portions configured to freely transition between closed and open configurations, and stiffer portions exhibiting increased stiffness or rigidity relative to the movable portions.
A method of manufacturing an implantable medical device with radiopaque properties, the method includes converting an ingot of a metal alloy with radiopaque and super elastic properties into a rod. The method also includes drilling the rod to create a hollow tube. The method also includes drawing the tube. The method also includes manufacturing an implantable medical device form from the tube. The method also includes finishing the implantable medical device form to create an implantable medical device.
A storage jar assembly for use with a prosthetic heart valve is disclosed in several embodiments. As one example, a storage jar assembly can include a jar having an open end and configured to receive a prosthetic heart valve. The embodiment also includes a lid configured to cover the open end of the jar. The lid can include a plurality of valve attachment features configured to be releasably attached to corresponding features of the prosthetic heart valve.
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
In one embodiment, a prosthetic valve assembly includes an annular frame being radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, a valvular structure comprising a plurality of leaflets mounted inside the annular frame, a plurality of posts mounted on an interior surface of the annular frame, and a pair of commissure attachment members extending outwardly from each post and away from each other. Each two adjacent leaflets can form a pair of commissure tabs. Each pair of commissure tabs can be attached to a corresponding pair of the commissure attachment members.
A valve repair system for repairing a native valve of a patient during a non-open-heart procedure includes a delivery device and a valve repair device. The valve repair device include a pair of paddles, first gripping member, a second gripping member, and a spacer. First and second gripping member controls or first and second gripping member control portions are coupled to the first and second gripping members to move the gripping members. The spacer element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.
A delivery apparatus for implanting a prosthetic valve is disclosed. The prosthetic valve can comprise a mechanically actuatable frame comprising at least one actuator member, the actuator member configured to be rotated to radially expand or compress the frame. The delivery apparatus can comprise at least one actuator assembly configured to actuate the actuator member of the prosthetic valve, the actuator assembly comprising an outer sleeve member having a lumen and an inner driver member coaxially disposed within the lumen of the sleeve member, the driver member being rotatable relative to the sleeve member, wherein the actuator assembly is configured to be transitioned between an engaged state and a disengaged state with the prosthetic valve, and wherein the driver member is configured to be selectively magnetically coupled to the actuator member in the engaged state.
Devices are configured to be positioned within a native heart valve to impede regurgitation through the native heart valve. The devices can include one or more of an expandable coaptation element and/or an extension or blocking member. The expandable coaptation elements can be adjustable in size, shape, or both to control the area of the native heart valve that is filled by the coaptation element. The expandable coaptation elements, extensions, and/or blocking members can be positioned in the native heart valve, such that regurgitant blood flow is blocked or impeded.
Methods for attaching a component to a frame of a prosthetic heart valve are disclosed. As one example, a method includes forming a stitching line along an edge portion of an outer skirt for a prosthetic valve with in-and-out stitches that extend along the edge portion, spaced away from a free edge of the edge portion, and a plurality of loops that are spaced apart from one another in a direction of the in-and-out stitches, each loop circling around the free edge and extending between the edge and an intersection of two adjacent in- and-out stitches. The method further includes attaching the edge portion to struts of a frame of the prosthetic valve by extending whip stitches through the loops and around the struts such that the free edge is positioned against radially outward facing surfaces of the struts and away from leaflets arranged inside the frame.
Medical apparatus and instruments for monitoring of patients, including, sensors, cables, parts and fittings for the aforesaid goods; Medical and surgical apparatus and instruments for treating cardiovascular disease;
