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
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
3.
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.
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.
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
12.
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 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.
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
17.
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.
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
30.
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
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 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
40.
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
42.
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
52.
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.
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.
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.
Components for valve treatment systems are disclosed. Valve treatment systems can include a delivery system for an implantable device. The delivery system can include one or more of clasp control components slidably disposed on a catheter handle, a control element for opening and closing the implantable device, a catheter assembly with features to reduce friction with another catheter assembly, grips for attaching catheter assemblies to clamps, catheter assemblies with features that stiffen or provide variable stiffness, and catheter assemblies with one or more steering control lumens incorporated into a reinforcement layer.
A medical balloon sensing assembly constituted of: a handle; a first catheter extending distally from the handle; an inflatable medical balloon, the inflatable medical balloon secured by the first catheter; at least one sensor position member; and at least one sensor secured to the at least one sensor position member, wherein the at least one sensor position member is arranged to contact an outer face of the inflatable medical balloon.
An introducer device includes a proximal hub including a first port and a second port, first and second fluid valves associated with the first port and the second port, respectively, a first elongate lumen projecting distally from the proximal hub, the first elongate lumen being in fluid communication with the first port, and a second elongate lumen projecting distally from the proximal hub, the second elongate lumen being in fluid communication with the second port and fluidly isolated from the first elongate lumen.
Described embodiments are directed toward prosthetic valve leaflets of a particular shape that allows redundant coaptation height in the leaflets when a planar segment is present in each leaflet.
Balloon compositions that may be used for deployment of implants within a patient's body. The balloons in examples may be utilized for dilating implants and may be coupled to a delivery catheter for an implant. In examples, the balloons may be utilized to dilate other surfaces within the patient's body.
A61L 29/06 - Matériaux macromoléculaires obtenus autrement que par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone
A61L 29/14 - Matériaux caractérisés par leur fonction ou leurs propriétés physiques
62.
SECURING A GUIDEWIRE DELIVERY CATHETER IN THE CORONARY SINUS USING MATERIAL OR ADVANCEMENT MECHANISMS
Mechanisms are disclosed for securing a catheter in place to facilitate puncturing a hole through a vessel wall. The securing mechanisms include bubbles, meshes, flaps, or similar features that expand when activated to press against the wall of the vessel (e.g., coronary sinus). Activation of the securing mechanisms occurs through removal of a restraint (e.g., a cover) or by pushing or pulling a wire. The securing mechanisms activated by removal of a restraint may self-expand or may expand due to a spring within a mesh structure. The securing mechanisms activated by pushing or pulling a wire expand due to movement of the wire itself or due to movement of a component attached to the wire and to the anchor member.
Valve repair devices and systems configured to detect proper valve leaflet insertion. The device/system can have a pair of paddles and a clasp attached to each of the paddles. The clasps can have a fixed arm attached to the paddle, a movable arm connected to the fixed arm that is movable between an open position and a closed position. The device can have an indicator that can move between not engaged by a leaflet and engaged by a leaflet conditions to indicate capture of a leaflet of the native valve. The indicator can be compressible. The indicator can be flattenable. The indicator can include one or more marker.
A method and apparatus for non-invasively determining a tissue arterial oxygen saturation value of a tissue body is provided. The method includes: a) transmitting at least a first wavelength and a second wavelength of near-infrared light into a tissue body, the first wavelength different from the second wavelength; b) sensing the tissue body for the near-infrared light, and producing signals representative of the sensed near-infrared light; c) determining an AC component of a first tissue oxygen parameter using the signals; d) determining an AC component of a second tissue oxygen parameter using the signals; and e) determining a tissue arterial oxygen saturation value of a tissue body using the determined AC component of the first tissue oxygen parameter and the determined AC component of the second tissue oxygen parameter.
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
65.
LEARNING AND PREDICTING TEMPORAL PROFILES OF PHYSIOLOGICAL STATES ASSOCIATED WITH THE ADMINISTRATION OF COMMONLY USED CRITICAL CARE DRUGS
A method for identifying physiological states of a patient includes receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient; performing, by the hemodynamic monitor, waveform analysis of the hemodynamic data to determine a plurality of profiling parameters; extracting, by the hemodynamic monitor, a patient data segment comprising a patient data set for a first profiling parameter of the plurality of profiling parameters; comparing, by the hemodynamic monitor, the patient data segment to a plurality of stored data segments from a database, each of the plurality of stored data segments having an associated stored discrete state data set indicative of whether a clinical intervention was administered and a stored data set for the first profiling parameter; identifying, by the hemodynamic monitor, a plurality of stored data segments satisfying threshold similarity criteria with respect to the patient data segment; and displaying, by the hemodynamic monitor, a predicted discrete state indicator of the patient.
G16H 50/20 - 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 le diagnostic assisté par ordinateur, p.ex. basé sur des systèmes experts médicaux
G16H 40/63 - TIC spécialement adaptées à la gestion ou à l’administration de ressources ou d’établissements de santé; TIC spécialement adaptées à la gestion ou au fonctionnement d’équipement ou de dispositifs médicaux pour le fonctionnement d’équipement ou de dispositifs médicaux pour le fonctionnement local
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
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
A method and device for advancing a guidewire past a calcified leaflet of a heart valve are described. A dual guidewire device includes a primary guidewire, a secondary guidewire, and a sheath. The primary guidewire is configured to advance past a heart valve while the secondary guidewire is configured to pull open the calcified leaflet of the heart valve while the primary guidewire advances past the heart valve. The catheter can contain both the primary guidewire and the secondary guidewire.
A61B 17/22 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets pour l'élimination non prévue ailleurs des obstructions dans les vaisseaux sanguins
A61B 17/00 - Instruments, dispositifs ou procédés chirurgicaux, p.ex. tourniquets
67.
DEVICES, SYSTEMS AND METHODS FOR ACCURATE POSITIONING OF A PROSTHETIC VALVE
The invention is a system and method for accurately positioning a prosthetic valve such as a prosthetic heart valve at a desired position for deployment. The invention includes extendable positioning elements which provide tactile feedback to a user to confirm proper positioning of the catheter with respect to the native valve annulus. During delivery, the extendable positioning elements may lie against or near the catheter, over the prosthetic valve and expandable balloon, providing a low profile for advancing the catheter to the desired treatment location via small passages such as body lumens. Prior to valve deployment, the positioning elements are extended and brought into contact with tissue of the native annulus to confirm the proper positioning of the delivery system and prosthetic valve.
Expandable docking stations for docking an expandable valve can include a valve seat, one or in ore sealing portions, and one or more retaining portions. A system for deploying an expandable docking station can include a catheter having a sleeve for retaining the docking station.
In one example, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. A size of the spacer body is configured to be adjusted after the spacer body is placed between the native valve leaflets and the pair of anchors are placed against the ventricular surfaces of the native heart valve leaflets. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.
Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a valved conduit prosthesis including a valved conduit subassembly within a secondary conduit. The valved conduit subassembly include at least one leaflet that is coupled to an exterior surface of a primary conduit.
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.
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 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
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
72.
ASSEMBLIES OF AN EXPANDABLE PROSTHETIC HEART VALVE WITHIN AN ANNULOPLASTY RING
The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.
A multiple location pressure sensing device for use with a prosthetic heart valve delivery assembly is disclosed in several examples. As one example, a prosthetic heart valve delivery assembly with a multiple location pressure sensing device can include a delivery apparatus, a guidewire, and a delivery apparatus. The example also includes a first pressure sensor configured to be positioned near an inlet end of a prosthetic heart valve and a second pressure sensor configured to be positioned near an outlet end of the prosthetic heart valve, wherein the first and second sensor are configured to measure a pressure gradient across the prosthetic heart valve.
Disclosed herein are implantable medical devices comprising a textile material comprising a first material and a second material having different stretchability and flexibility, where the first and the second materials are at least partially superposed and coupled to each other. The medical devices of the current disclosure can be implantable prosthetic valves. The valves of the present disclosure provide for a reduced crimped profile and improve PVL sealing. In addition, disclosed herein are methods of making the implantable medical devices.
A prosthetic heart valve including a radially expandable and compressible annular frame is disclosed. The frame includes a plurality of interconnected struts defining a plurality of rows of cells arranged between an inflow end and an outflow end of the frame, the interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. The frame further includes a plurality of apex regions formed at the inflow end and the outflow end, each apex region curving between two angled strut portions and forming one of the outflow struts or one of the inflow struts with the two angled strut portions. Each apex region has a narrowed width and a length that extends along at least 25% of a total length of the outflow strut or inflow strut, the narrowed width smaller than a width of the two angled strut portions.
A system for introducing a delivery apparatus into a patient's vasculature. The system may include a sheath having a lumen and configured to be inserted into the patient's vasculature. An introducer has a channel for receiving a guide wire and is configured to be positioned within the lumen of the sheath. A plug is coupled to the introducer and is configured to move from a first position in which the plug has a first diameter to a second position in which the plug has a second diameter that is greater than the first diameter and greater than the interior diameter of the sheath, the plug being configured to slide within the lumen in a direction from the distal end of the sheath towards the proximal end of the sheath to expand the sheath in the direction radially outward from the lumen.
A method of implanting a prosthetic heart valve includes determining from a set of expandable prosthetic heart valves a first prosthetic heart valve. The first prosthetic heart valve has a first nominal diameter less than a native annulus diameter. The method further includes determining a first suggested expanded diameter for the first prosthetic heart valve based on the native annulus diameter, wherein the first suggested expanded diameter is greater than the first nominal diameter, and determining a pressure gradient across the first prosthetic heart valve at the first suggested expanded diameter based at least in part on pressure values from hemodynamic data of the first prosthetic heart valve. The method further includes selecting the prosthetic heart valve from the set of expandable prosthetic heart valves with the suggested expanded diameter resulting in the lowest pressure gradient for implantation from the set of prosthetic heart valves.
A delivery catheter is in various examples configured to deliver an anchoring device to a native valve annulus of a patient's heart, where the anchoring device can better secure a prosthesis at the native annulus. The delivery catheter in examples may be configured to deflect in a ventricular direction during deployment of an anchoring device. Examples of docking coil sleeves and docking coils are disclosed herein.
A delivery apparatus for a medical device implant can include an outer catheter and a flexible delivery catheter. The outer catheter can have an axially extending shaft and a first lumen extending co-axially through the axially extending shaft. The flexible delivery catheter can have an elongate shaft having a flexible section extending along a distal portion of the elongate shaft, and the flexible section of the elongate shaft can be positioned or adjusted between a first, delivery configuration and a second, activated configuration. The delivery catheter can have a pull wire extending co-axially through a second lumen axially extending through the elongate shaft. A distal end of the pull wire can be fixedly secured or attached to the distal end of the elongate shaft.
An implant may be affixed to a cardiac valve annulus by an apparatus that includes a catheter with a first actuatable bending section and a support structure affixed to the distal end of the catheter. Support arms extend distally beyond the support structure. In some embodiments, a shaft with a second actuatable bending section is permanently positioned between the support arms, and an inflatable balloon surrounds at least a portion of the shaft. In other embodiments, a subassembly that includes a shaft with a second actuatable bending section and an inflatable balloon is slidably mounted so that it can move from an initial position that is spaced apart from the support structure to a second position where the balloon is between the at least four support arms. In either case, actuating the second bending section when the balloon is inflated will move the support arms that support the implant.
Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A prosthetic heart valve includes a valve structure and a frame. The valve structure includes a plurality of leaflets, and the leaflets are configured to move from an open configuration to a closed configuration. The valve structure is coupled to the frame. The frame includes an inflow end, an outflow end, a longitudinal axis extending from the inflow end to the outflow end, and a plurality of struts forming a plurality of rows of cells. Each row of cells extends in a circumferential direction perpendicular to the longitudinal axis. Adjacent cells in a row of cell are coupled together at a junction of the struts defining the adjacent cells, and at least one junction in one row of cells has a shape that is different than at least one other junction of the one row of cells.
A stabilizing base includes one or more legs and a platform attached to the one or more legs. One or more of a height of the platform relative to an operating table, a position of the platform along a width of the operating table, a position of the platform along a length of the operating table, and an angular position of the platform relative to the operating table can be adjusted.
A method of treating a deficient native mitral valve of a heart of a patient includes advancing a steerable, first catheter through the patient's vasculature, advancing the distal end portion of the first catheter into the heart to position the distal end portion of the first catheter adjacent the native mitral valve, adjusting the curvature of the distal end portion of the first catheter to form a first curve, advancing a distal end portion of a second catheter from a distal end of the first catheter, wherein the distal end portion of the second catheter is pre-shaped to form a second curve when advanced from the first catheter, and deploying a wire from the second catheter such that the wire extends around native leaflets of the native mitral valve.
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 17/12 - 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
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
Catheter systems and methods including a hydraulic shock arrestor. A system may include an inflatable balloon for insertion within a patient's body. The inflatable balloon may be configured to be inflated with a fluid within the patient's body. The system may further include an elongate shaft. The elongate shaft may be configured to extend within the patient's body. The system may further include a fluid conduit. The system may further include a hydraulic shock arrestor configured to mitigate pressure surge within the fluid conduit.
Systems and methods for contactless control of a physiological monitor are provided. A number of systems utilize an input device for audio-based control of a physiological monitor and/or an input device for gesture-based control of a physiological monitor. Many systems process audio (e.g., voice) or gesture commands to direct a physiological monitor to perform actions, such as begin monitoring, silencing an alarm, changing parameters, navigating screens and/or menus, and/or any other function. Such contactless systems reduce or eliminate physical contact with a physiological monitor, which can mitigate contamination between patients or individuals, which can occur via traditional systems.
This disclosure is directed to prosthetic heart valves having elongated sealing members. As one example, a prosthetic heart valve comprises an annular frame, a leaflet assembly comprising a plurality of leaflets, and a skirt assembly comprising an inner skirt, an outer skirt, and/or a third skirt. The frame is radially compressible and expandable between a radially compressed state and a radially expanded state and comprises a plurality of apices at an inflow end. The skirt assembly forms a pocket at the inflow end of the frame that creates extra space between the inflow end of the frame and the skirt assembly when the frame is in the radially expanded state. This pocket allows the apices at the inflow end of the frame to move towards an inflow end of the pocket when the frame is radially compressed to the radially compressed state without protruding through the skirt assembly.
A fabric having a honeycomb weave pattern is provided for use with medical implants. The fabric may be heat treated to increase a thickness and texture of the fabric. The fabric may be compliant and compressible for providing cushioning within a patient's body. For example, the fabric may be applied to a prosthetic valve to cushion a portion of the prosthetic heart valve. The fabric may also be textured to provide enhanced friction between the prosthetic heart valve and the surrounding native tissue. Enhanced friction may be achieved by weave patterns or by the inclusion of protrusions or barbs in the fabric.
A hemodynamic monitor for detecting nociception of a patient includes a non-invasive blood pressure sensor with an inflatable blood pressure bladder, a pressure controller pneumatically connected to the inflatable blood pressure bladder, and an optical transmitter and an optical receiver that are electrically connected to the pressure controller. The hemodynamic monitor also includes an integrated hardware unit with a system processor, a system memory, and a display with a user interface.
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 5/00 - Mesure servant à établir un diagnostic ; Identification des individus
A61B 5/349 - Détection de paramètres spécifiques du cycle de l'électrocardiogramme
A61B 5/024 - Mesure du pouls ou des pulsations cardiaques
89.
DEVICES FOR ASSISTING WITH HEART VALVE MANUFACTURING
An assistance system that can be used for prosthetic heart valve manufacturing or suturing procedures includes an automated fixture that can comprise an articulation arm and a target device holder. The target device holder can be positioned and oriented to reduce operator strain during a manufacturing or inspection process. The assistance system includes a user input device enabling the operator to move between positions to assist in such processes. The assistance system can also be trained by capturing sequences of position data corresponding to a manufacturing or inspection process.
A prosthetic heart valve has a frame and a valvular structure supported by the frame. The frame has cells distributed circumferentially around the frame and formed by struts. The struts includes a support arm, which has a fixed end portion extending from an axial end portion of the frame and a free end portion disposed toward an opposite axial end portion of the frame relative to the fixed end portion. The fixed end portion has a rotational position that is rotationally offset relate to that of the free end portion. When the frame is in a radially-compressed configuration, a second locking member of the struts is spaced apart from a first locking member of the free end portion of the support arm. When the frame is in the radially-expanded configuration, the second locking member engages the first locking member, thereby restricting the frame from moving from the radially-expanded configuration.
Systems of quickly and easily implanting a quick-connect heart valve prosthesis during a surgical procedure are provided. The heart valve may include a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A system and method for deployment includes an integrated handle shaft and balloon catheter. A safety member disposed between the balloon catheter and handle shaft prevents premature catheter advancement prior to heart valve placement at the annulus, and also may prevent premature balloon inflation prior to full catheter advancement.
A first end of a wire is transluminally penetrated through tissue at a first cardiovascular site of a subject. A capture device is transluminally advanced into the subject, and is used to capture the first end of the wire and pull the first end of the wire away from the first cardiovascular site. From the first end of the wire, a first anchor is tracked along the wire, and is then anchored to the tissue at the first cardiovascular site. A second anchor is anchored to tissue at a second cardiovascular site. Subsequently, the first and second cardiovascular sites are drawn together by applying tension between the first and second anchors. 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
A medical instrument includes a handle, a suture lock associated with the handle, the suture lock being configured to fix a position of a portion of a suture line relative to a portion of the handle when the suture lock is in a locked configuration, and a manually-actuatable actuator associated with the handle and configured to cause the suture lock to transition from the locked position to an unlocked position.
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 system that can be used for suturing implants includes a first automated fixture that can comprise an articulation arm and a target device holder and a second automated fixture configured to operate as a sewing machine to sew material onto the implant. The second automated fixture uses a curved needle to form a stitch without having to release the needle in the process. The second automated fixture can also include a stitch looper that moves in coordination with the curved needle to perform a single-suture or single-thread stitch.
A method of preparing a suture for use in medical treatment involves treating a surface of the suture, applying a coating to the suture, and treating the coating to cause adhesion of the coating to the suture.
A prosthetic implant delivery assembly includes a prosthetic implant and a catheter. The prosthetic implant includes a plurality of apices with apertures. Each apex of the plurality of apices is circumferentially-spaced apart relative to an adjacent apex. The catheter includes a plurality of arms and a plurality of locking elements. Each of the arms includes an opening configured to receive a respective apex of the prosthetic implant. Each of the locking elements is configured to extend through the aperture of a respective apex of the prosthetic implant. A length of at least one of the locking elements is different than a length of another locking element such that when the prosthetic implant is coupled to the catheter by the locking elements, a longitudinal axis of the prosthetic implant can be held at a tilted position relative to a longitudinal axis of the catheter.
A testing apparatus is disclosed herein for testing properties of a prosthetic device. The testing apparatus may comprise a dual-drive pulsatile flow tester with the ability to determine coaptation of valve leaflets of a prosthetic device. The testing apparatus may be able to test prosthetic heart valves and reproduce physiological conditions of a prosthetic heart valve.
A61F 2/76 - Moyens pour assembler, ajuster ou tester les prothèses, p.ex. pour mesurer ou équilibrer
F16K 37/00 - Moyens particuliers portés par ou sur les soupapes ou autres dispositifs d'obturation pour repérer ou enregistrer leur fonctionnement ou pour permettre de donner l'alarme
A sensor implant device includes a shunt body that forms a fluid conduit, a first anchor structure associated with a first axial end of the shunt body, and a first sensor-retention structure associated with a second axial end of the shunt body, the first sensor-retention structure being configured to hold a first sensor device in a sensing position in which a sensor transducer of the first sensor device is disposed at least partially radially outside of a channel area of the fluid conduit.
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 through which the cardiovascular device and its delivery system pass. In an embodiment, the annular inner member can be formed by coextruding a first and second material. The first material includes a fold, and the second material radially spaces the different parts of the fold from each other during fabrication and provides support for maintaining the tubular structure. The second material is removed once the coextrusion process is complete.
B29C 48/00 - Moulage par extrusion, c. à d. en exprimant la matière à mouler dans une matrice ou une filière qui lui donne la forme désirée; Appareils à cet effet
B29C 48/21 - Articles comprenant au moins deux composants, p.ex. couches coextrudées les composants étant des couches les couches étant jointes à leurs surfaces
An implantable prosthetic valve may comprise a valve body having a proximal end, a distal end, an outer surface, and an inner surface facing a flow channel, and a skirt including a first level forming at least a portion of the outer surface of the valve body and configured to be thromboresistant and a second level forming at least a portion of the outer surface of the valve body and configured to allow tissue ingrowth with the second level. A plurality of prosthetic valve leaflets may be positioned within the flow channel and extend inward from the inner surface of the valve body.
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