Abstract: A fixation band has a tubular frame and a tube, wherein the tubular frame comprises longitudinally-extending members having a hook on its distal end and fixation means on its proximal end. The tubular frame preferably comprises a laterally-extending member for stabilization. The tube is positioned inside longitudinally-extending members and a sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members. A standard prosthetic valve can be secured to the fixation band by suturing the prosthetic valve's sewing cuff to the fixation band's sewing cuff and the prosthetic valve can be advanced to a valve seat. By pulling the tubular frame proximally, the hooks pass into surrounding tissue so that the fixation band and prosthetic valve are fixed against proximal movement. The fixation means then secure the fixation band to the surrounding tissue so that the prosthetic valve is fixed against distal movement.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement aims that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Abstract: A fixation band has a tubular frame and a tube, wherein the tubular frame comprises longitudinally-extending members having a hook on its distal end and fixation means on its proximal end. The tubular frame preferably comprises a laterally-extending member for stabilization. The tube is positioned inside longitudinally-extending members and a sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members. A standard prosthetic valve can be secured to the fixation band by suturing the prosthetic valve's sewing cuff to the fixation band's sewing cuff and the prosthetic valve can be advanced to a valve seat. By pulling the tubular frame proximally, the hooks pass into surrounding tissue so that the fixation band and prosthetic valve are fixed against proximal movement. The fixation means then secure the fixation band to the surrounding tissue so that the prosthetic valve is fixed against distal movement.

Abstract: A heart valve comprises a stent and a sewing cuff comprising a stiffening ring, wherein the stent and the stiffening ring are adapted to be snap-fitted. In one embodiment, the stent and the stiffening ring can together comprise one or more projections and one or more openings.

Abstract: A heart valve assembly includes a base including a multi-lobular annular shape within a plane, a valve member or other annular body including a multi-lobular shape complementary to the shape of the base, and cooperating connectors on the base and the annular body for connecting the annular body to the base. The base includes an anchoring ring, and a flexible cuff for attaching the base to a biological annulus. The base and the annular body include guides for aligning their multi-lobular shapes, e.g., visual, tactile, or other markers, or tethers that extend from the base that are slidable through the annular body. During use, the base is attached to a biological annulus, the annular body is directed adjacent the annulus, oriented such that the multi-lobular shape of the annular body valve member is aligned with the base, and the annular body is attached to the base.

Abstract: A device, system and method provides mitral valve therapy. The device is implantable in the coronary sinus of the heart to partially encircle the mitral valve annulus. The device is elongated, is resilient, and has a preformed arched configuration. When the device is implanted in the coronary sinus, the device exerts a substantially radially inward force to the mitral valve to restore mitral valve annulus geometry.

Abstract: A prosthetic heart valve assembly includes a gasket member and a valve member including a plurality of fasteners and a plurality of engagement members corresponding to the fasteners. The fasteners and/or engagement members may be configured to guide the engagement members into engagement with the fasteners. For example, the fasteners may include U-shaped spring-biased clips, e.g., attached to a core or other portion of a sewing cuff of the gasket member, and the engagement members may include latches or barbed protrusions that engage one or more holes in the fasteners. During use, the gasket member is introduced into a tissue annulus, and secured to the annulus, e.g., using a plurality of clips directed through the sewing cuff. The valve member is then introduced into the annulus and the engagement members are snapped or otherwise guided into engagement with the fasteners to secure the valve member relative to the gasket member.

Abstract: The invention concerns a method for preauthentication of a first entity (10) by a second entity (1) communicating with each other through a wireless link, including the following steps: the second entity (1) emits (23?) a challenge value (c); if the first entity (10) receives (23) a challenge value (c?) it applies to the received challenge value a predefined transformation (g) known to the second entity, to obtain a first transformed value (r), then emits (24) the first transformed value obtained; and if the second entity receives (24?) a transformed value (r?) it compares (25?) the received transformed value to a second transformed value (r?) obtained by applying the predefined transformation (g) to the emitted challenge value, and estimates the preauthentication to be successful if the result of the comparison between the second transformed value obtained and the received transformed value is less than a predefined threshold (m).

Abstract: A prosthetic heart valve assembly includes a gasket member and a valve member including a plurality of fasteners and a plurality of engagement members corresponding to the fasteners. The fasteners and/or engagement members may be configured to guide the engagement members into engagement with the fasteners. For example, the fasteners may include U-shaped spring-biased clips, e.g., attached to a core or other portion of a sewing cuff of the gasket member, and the engagement members may include latches or barbed protrusions that engage one or more holes in the fasteners. During use, the gasket member is introduced into a tissue annulus, and secured to the annulus, e.g., using a plurality of clips directed through the sewing cuff. The valve member is then introduced into the annulus and the engagement members are snapped or otherwise guided into engagement with the fasteners to secure the valve member relative to the gasket member.

Abstract: Apparatus is provided for repairing a valve of a patient, the valve including an annulus and at least first and second leaflets. The apparatus includes at least a first discrete segment and a second discrete segment of an annuloplasty structure, each segment being shaped to provide a respective lateral wall, each lateral wall being shaped to define at least one lumen of the respective segment. The apparatus further includes at least a first and a second control wire, each control wire configured for sliding advancement through both the first and second segments. The first control wire is configured to control a relative disposition of a first end of the first segment and a first end of the second segment. The second control wire is configured to control a relative disposition of a second end of the first segment and a second end of the second segment. Other embodiments are also described.

Abstract: A prosthetic heart valve includes an annular stent having annularly spaced commissure portions. The tips of the commissure portions are preferably covered with fabric, and then additional fabric covers that fabric and the remainder of the stent, both inside and out (possibly also including a sewing ring insert at or near the base or inflow edge). The fabric is then covered by a layer of tissue, again both inside and out. A single sheet of additional tissue is mounted around the outside of the previously assembled components. This additional tissue forms the leaflet portions of the valve. The leaflet portions of the additional tissue are shaped by contact with a shaped mandrel, and the tissue of the structure is subjected to fixation (e.g., cross-linking) to produce a completed valve.

Abstract: A fixation band has a tubular frame and a tube, wherein the tubular frame comprises longitudinally-extending members having a hook on its distal end and fixation means on its proximal end. The tubular frame preferably comprises a laterally-extending member for stabilization. The tube is positioned inside longitudinally-extending members and a sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members. A standard prosthetic valve can be secured to the fixation band by suturing the prosthetic valve's sewing cuff to the fixation band's sewing cuff and the prosthetic valve can be advanced to a valve seat. By pulling the tubular frame proximally, the hooks pass into surrounding tissue so that the fixation band and prosthetic valve are fixed against proximal movement. The fixation means then secure the fixation band to the surrounding tissue so that the prosthetic valve is fixed against distal movement.

Abstract: A prosthetic heart valve replacement system and method aim to reduce the time duration of the patient on the heart-lung machine during surgery. In one embodiment, the invention uses a two rings (e.g., of Titanium) comprising a first outer anchoring ring installed in a first step in the patient annulus, e.g., by stapling (e.g., using Nitinol® staples), and a second inner valve ring which has apertures and to which the sewing cuff of prosthetic heart valve (e.g., of Dacron) is sutured around the sewing cuff. The suturing is expediently completed outside of the patient's body, parallel with the stapling of the anchoring ring in the patient annulus. The inner valve ring may have circumferential resiliency. The inner valve ring along with the fastened/sutured prosthetic valve is installed snugly (in a second step) to be captively retained concentrically within the already installed outer anchoring ring, to complete the heart valve replacement.

Abstract: A fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising: a structure having a proximal end and a distal end in opposition to one another, and a lateral region between the proximal end and the distal end, wherein the prosthetic heart valve is attached to one of the proximal end and the distal end of the structure; a plurality of barbs selectively configurable between a first position and a second position, the barbs being contained within a peripheral boundary of the lateral region of the structure in the first position, and the barbs being extended from the peripheral boundary of the lateral region of the structure in the second position; and an actuator for selectively moving the plurality of barbs between the first position and the second position.

Abstract: A valve prosthesis includes a plurality of flexible leaflets and a stent having a central lumen. A slit in the stent extends from the central lumen to an outer surface. An occluding portion of the flexible leaflets extends across the central lumen and an attachment portion extends from the central lumen through the slit and forms a sewing cuff for attachment to a patient's tissue. The attachment portion forms a sewing cuff for attachment to native heart tissue.

Abstract: A prosthetic heart value assembly comprising a prosthetic heart valve and a fixation band. The fixation band comprises a tubular frame and a tube. The tubular frame comprises longitudinally-extending members having hooks on their distal ends and fixation means on proximal ends, and a stabilizing laterally-extending member. The tube is positioned inside the longitudinally-extending members, a distal end of the tube being everted over the hooks. A sewing cuff is formed in the tube. The prosthetic valve is secured to the fixation band by suturing a prosthetic valve sewing cuff to a fixation band sewing cuff. The prosthetic valve and fixation band are advanced to the valve's seat. The fixation band's hooks are passed through the wall of the everted tube and into surrounding tissue and the fixation band's fixation means are deployed.

Abstract: A suture locking assembly for use with a heart valve repair device. The suture locking assembly including a rim and a suture band. The rim defines a first flange and a second flange spaced from the first flange. The rim is configured to extend at least partially around a periphery of the heart valve repair device. The suture band is maintained between the first flange and the second flange. The suture locking assembly is configured to securely maintain a suture segment that is pulled from a first position to a second position relative the suture locking assembly, the second position being at least partially defined near an outer periphery of the rim.

Abstract: A sewing ring for prosthetic heart valves that is connected and configured to pivot outward. A biocompatible fabric covering surrounds at least a portion of the sewing ring, and the ring may be exclusively connected to a stent with the fabric. The sewing ring may be generally planar and of uniform thickness, or may be of varying thickness. The fabric may be used to encompass both the stent and the sewing ring, and may be a single piece. A seam may be provided in the fabric as a discrete pivoting line. The sewing ring may be convertible between bi-stable positions. The ring may extend outward in a frusto-conical shape so as to enable inversion between a position facing the inflow end of the valve and a position facing the outflow end of the valve. The sewing ring may have a compliant insert having a celled construction defined by outer walls and inner ribs. A method of implantation, and a method of assembly of the heart valve is also provided.

Abstract: A highly flexible tissue-type heart valve is disclosed having a structural stent in a generally cylindrical configuration with cusps and commissures that are permitted to move radially. The stent commissures are constructed so that the cusps are pivotably or flexibly coupled together at the commissures to permit relative movement therebetween. The stent may be cloth-covered and may be a single element or may be made in three separate elements for a three cusp valve, each element having a cusp portion and two commissure portions; adjacent commissure portions for each pair of adjacent stent element combining to form the stent commissures. If the stent has separate elements their commissure portions may be pivotably or flexible coupled, or may be designed to completely separate into independent leaflets at bioresorbable couples. The cloth covering may have an outwardly projecting flap that mates with valve leaflets (e.g., pericardial leaflets) along the cusps and commissures.

Abstract: A heart valve prosthesis having a valve housing providing a lumen therethrough. The valve housing has a first annulus on one end and a second annulus on the other end spaced apart from the first annulus. A suture cuff is used for attaching the valve housing to heart tissue of a patient. The cuff is attached between the first annulus and the second annulus. The cuff is positioned such that prosthesis is attached in a supra-annular position relative to a tissue annulus of the heart. The design allows for an increased valve lumen.

Abstract: The present invention provides a prosthetic valve and a sewing cuff assembly for attaching the prosthetic valve in a patient's heart. The suture cuff generally includes at least one lock ring and sewing cuff material disposed at least partially around the lock ring. The valve body includes a peripheral groove for receiving the lock ring therein and securing the lock ring thereto. A stiffening ring may be coupled to the peripheral groove or otherwise provided on the valve body.

Abstract: The present invention provides a suture-terminating device comprising a central body having at least one surface, a plurality of flanges extending radially from the surface and defining at least one grove therebetween, each flange having at least one aperture axially aligned and spaced away from the base wall, at least one removable member disposed within each aperture, and at least one spring disposed adjacently to the surface and maintained in its activated state by contact with a removable member disposed within the aperture. The grove has a base wall and at least one sidewall. The spring, while in its active state, is positioned adjacent to and spaced from the base wall, defining a gap of sufficient size to permit the passage of at least one suture therethrough. The surgeon actuates the device by withdrawing the removable member from the aperture, thus permitting the spring to return to its resting state within the grove.

Abstract: A prosthetic heart valve having an orifice is configured to allow blood flow through an orifice. A suture cuff extends around an outer circumference of an outer ring. The suture cuff is adapted for attachment to a native tissue annulus of a patient. A weld between the suture cuff and the ring is configured to attach the suture cuff to the ring.

Abstract: A heart valve prosthesis has a frame that includes at least one outwardly extending annular flange adjacent to a suturing ring and a band comprising an inwardly extending annular flange that is capable of engagement with the annular flange of the frame. A tortuous path is formed between the annular flange of the frame and the annular flange of the band that can engage and restrain a suture placed between them. One or more split portions or tab portions on the band are adapted to lock the band in engagement with the flange of the frame. Such a device can be used to more easily replace a heart valve by advancing a sutures through a suturing ring on the valve and the valvular rim such that they are brought outward of the flange extending from the frame and then advancing the band over the valve and over the sutures at a proximal, outflow end of the valve until the band engages the flange and captures the sutures between the band and the flange.

Abstract: Suturing rings and methods of use thereof facilitating initial implantation of new and replacement of dysfunctional tissue or mechanical heart valve mechanisms supported by the suturing ring are disclosed. The suturing ring annulus is adjustable to receive and engage the valve frame of the heart valve mechanism within the annulus. An interlocking mechanism applies restraint to fix the adjusted suturing ring annulus engaged against the valve frame to support the heart valve mechanism during chronic implantation. Sutures affixing the suturing ring to the valvar rim can be routed and entrapped between the suturing ring annulus and the valve frame when the suturing ring is restraint is applied. The restraint is released to replace a dysfunctional heart valve mechanism and reapplied when a new heart valve mechanism is fitted into the annulus.

Abstract: A novel heart valve for permanent implantation inside the human heart. The heart valve includes a valve body with an outer valve body surface. The outer valve body surface has at least one projection. This projection serves to locate at least one stiffener on the valve body after the valve has been assembled. The projection includes structure that defines at least a partial interruption through the projection in a direction perpendicular to the valve body's exterior surface. In preferred embodiments, the projection extends around less than the entire outer surface of the valve body, or multiple projections jointly extend around less than the entire outer surface of the valve body.

Abstract: A trileaflet biological prosthetic heart valve (11, 41) comprising a thin, rigid annular outer frame (25, 43) which supports three elastic, laminated spring inner frames (18, 57) which in turn provide consistent geometric form and structure for attachment of tissue leaflets (15, 71).

Abstract: A prosthetic heart valve having an elastomeric valve body with an annular base for receiving a suture. A sewing cuff is coupled to the valve body and/or a stent member by a piercing suture or other connector member, such as a staple or pin. Apertures may be provided in the stent member.

Abstract: A prosthetic heart valve having an elastomeric stent with an annular base and a plurality of apertures or holes circumferentially spaced around the base for receiving a suture. Flexible polymeric leaflets are molded over the stent. Polymeric material surrounds the apertures, leaving a central opening in each aperture. The base may be a frustro-conical ring. A sewing ring is mounted on the heart valve by suturing the ring through the apertures. Apertures or holes may also be provided by extending an area covered by woven material around all or part of the circumference of the base.

Abstract: The present invention provides a prosthetic valve and a sewing cuff assembly for attaching the prosthetic valve in a patient's heart. The sewing cuff generally includes at least one lock ring and sewing cuff material disposed at least partially around the lock ring. The valve body includes a peripheral groove for receiving the lock ring therein and securing the lock ring thereto. A stiffening ring may be coupled to the peripheral groove or otherwise provided on the valve body.

Abstract: The present invention provides a prosthetic valve and a sewing cuff assembly for attaching the prosthetic valve in a patient's heart. The suture cuff generally includes at least one lock ring and sewing cuff material disposed at least partially around the lock ring. The valve body includes a peripheral groove for receiving the lock ring therein and securing the lock ring thereto. A stiffening ring may be coupled to the peripheral groove or otherwise provided on the valve body.

Abstract: A prosthetic heart valve for implantation in a heart includes an outer orifice ring and an inner orifice ring having an occluding mechanism carried therein. A ring coupling mechanism having helical threads is adapted to couple the outer orifice ring to the inner orifice ring after the outer orifice ring has been coupled to the tissue annulus. The coupling mechanism comprises a first helical thread on an outer diameter of the inner ring and a second helical thread on an inner diameter of the outer ring. At least one of the diameters includes a retaining ridge configured to define an unthreaded region between the retaining ridge and the respective thread. When a helical thread is positioned in the unthreaded region, the inner ring is rotatable in the outer ring with substantially no movement in an axial direction of the valve.

Abstract: A heart valve prosthesis having a valve housing providing a lumen therethrough. The valve housing has a first annulus on one end and a second annulus on the other end spaced apart from the first annulus. A suture cuff is used for attaching the valve housing to heart tissue of a patient. The cuff is attached between the first annulus and the second annulus. The cuff is positioned such that prosthesis is attached in a supra-annular position relative to a tissue annulus of the heart. The design allows for an increased valve lumen.

Abstract: A flexible leaflet heart valve includes an annular body and an annular base portion connected to an end of the body. A fabric member is molded into the base portion to form an uninterrupted annular fabric band around the periphery of the base portion. The fabric band may include a first portion molded into the base and a second portion extending from the base. Alternatively, the fabric band may be entirely encapsulated in the base. The valve fabric can be sutured directly to patient tissue, or the valve fabric can be sutured to an adjacent sewing cuff which is sutured to patient tissue.

Abstract: A novel fixation band for affixing a prosthetic heart valve in position within the heart. In one preferred form of the invention, the fixation band generally comprises a tubular frame having a distal end and a proximal end, and a tube having a distal end and a proximal end. The tubular frame comprises a plurality of longitudinally-extending members each having a hook on its distal end and fixation means on its proximal end. The tubular frame also comprises at least one laterally-extending member for stabilizing the longitudinally-extending members relative to one another so as to form the complete tubular frame. The tube is positioned inside the longitudinally-extending members, with the distal end of the tube being everted back over the aforementioned hooks. A sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members.

Abstract: A prosthetic heart valve includes an orifice ring adapted to carry blood therethrough. An annular recess is formed in an outer surface of the orifice ring and has first and second axially spaced walls. A sewing cuff is adapted to be coupled to a native tissue annulus of a heart and includes an inner annular cuff portion adapted to conform to the first and second recess walls in the orifice ring. A cuff retaining ring extends around the inner annular fabric portion such that the inner annular cuff portion is positioned between the cuff retaining ring and the annular recess.

Abstract: A system and method are disclosed for covering a mechanical heart valve with biological tissue to provide a biomechanical heart valve prosthesis. The prosthesis includes a mechanical heart valve having a moveable portion mounted within a generally annular support that permits substantially unidirectional flow of blood therethrough. One or more sheets of a biological tissue material are applied around the support heart valve to provide a sewing ring that includes the biological tissue material.

Abstract: A heart valve prosthesis which incorporates a substantially permanently implantable abutment structure which is surgically attached to a native heart valve annulus through utilization of a resilient metal substructure having an attachment portion which moves into engagement with a native heart annulus upon being released from a retracted orientation. The system employs a positioning instrument which locates the abutment structure and associated heart valve prosthesis at the proper location for releasing the attachment components. Mechanical heart valve components including an occluder function are removably attached to the abutment structure using sutures, such that the valve function itself may be subsequently replaced.

Abstract: An improved mechanical heart valve that reduces the time required to perform heart valve replacement surgery is provided. The mechanical heart valve is comprised of a valve body and a plurality of staples extending around the valve body that are coupled to the valve body through at least one intermediate member.

Abstract: A prosthetic heart valve for implantation in a heart includes an outer orifice ring for coupling to a tissue annulus of a heart. An inner orifice ring includes at least one leaflet occluder carried in a lumen of the inner orifice ring which is movable between an open position, which allows blood flow through the lumen, and a closed position which blocks blood flow through the lumen. The inner orifice ring is adapted to be coupled to the outer orifice ring after the outer orifice ring has been attached to the tissue annulus.