Abstract: Apparatus and methods for treating conditions such as rhinitis are disclosed herein where a distal end of a probe shaft is introduced through the nasal cavity where the distal end has an end effector with a first configuration having a low-profile which is shaped to manipulate tissue within the nasal cavity. The distal end may be positioned into proximity of a tissue region having a post nasal nerve associated with a middle or inferior nasal turbinate. Once suitably positioned, the distal end may be reconfigured from the first configuration to a second configuration which is shaped to contact and follow the tissue region and the post nasal nerve may then be ablated via the distal end. Ablation may be performed using various mechanisms, such as cryotherapy, and optionally under direct visualization.

Abstract: The present invention generally relates to a flexible catheter device capable of being introduced into body passages, withdraw fluids therefrom or introduce fluids thereinto, and which includes electrodes configured to apply electrical signals in the body passage for carrying out thrombus dissolution and/or thrombectomy, wherein one of said electrodes is designed to contact the thrombus material and remove it or dissolve it, and wherein the electrical voltage signals are a unipolar pulsatile voltage signal.

Abstract: An intra-cardiac mapping system is based on locating the ports through which blood flows in or out the heart chambers. For many procedures, such as ablation to cure atrial fibrillation, locating the pulmonary veins and the mitral valve accurately allows to perform a Maze procedure. The location of the ports and valves is based on using the convective cooling effect of the blood flow. The mapping can be performed by a catheter-deployed expandable net or a scanning catheter. The same net or catheter can also perform the ablation procedure.

Abstract: This invention relates to medical methods, instruments and systems for creating a controlled lesion using temperature to control the growth of the lesion. The treatment can be used in any tissue area and is particularly useful in or around a vertebral body. The features relating to the methods and devices described herein can be applied in any region of soft or hard tissue including bone or hard tissue.

Abstract: An ablation catheter comprises an elongate catheter body and a branch electrode element. The elongate catheter body has a central axis, a distal end, and a proximal end. The elongate catheter body is configured to be steered within a heart chamber. The branch electrode element has a base end and a working end or tip. The base end is secured to the elongate catheter body at a location spaced proximally of the distal end and an effector on the working end. The branch electrode element is configured to evert when the distal end of the elongate catheter body is in a pulmonary vein ostium or os so that the effector can be selectively engaged against locations surrounding the pulmonary vein os which differ in radial direction and distance. One or more of linear or curved ablation patterns are generated on tissue adjacent the pulmonary vein os with the effector.

Abstract: A connector assembly is provided. The connector assembly includes a housing having a first end that includes one or more mechanical interfaces thereon. The at least one mechanical interface configured to selectively engage a corresponding mechanical interface on an electrosurgical generator. A second end is configured to selectively engage an end of an electrosurgical cable to couple the electrosurgical generator to an electrosurgical instrument. A plurality of splines extends along an interior of the housing and is configured for electrical communication with a plurality of corresponding electrical conductors of the electrosurgical cable.

Abstract: An electromagnetic surgical ablation probe having a tunable helical antenna element includes a coaxial feedline having an inner conductor coaxially disposed within a dielectric, and an outer conductor coaxially disposed around the dielectric. The inner conductor and dielectric extend distally beyond a distal end of the outer conductor. A helical antenna element is operably coupled to a distal end of the inner conductor. During use, the antenna may be tuned by changing at least one dimension of the helical antenna element. Embodiments are presented wherein a dimension of the helical antenna element is changed by state change of a shape memory alloy, by a change in temperature, by activation of a piston by fluidic pressure, by linear motion of a conical tip, and by a manual screw-type adjustment.

Abstract: A robotic surgery system having a mobile base and a first moveable support structure coupled between the mobile base and a first element of a fluoroscopic imaging system. The first element is a source element or a detector element, and a second element of the imaging system is a source element or a detector element. The second element is configured to be repositionable relative to patient tissue disposed between the first and second elements. The system further includes a coupling member configured to fixedly couple the first element to the second element, and a surgical instrument for conducting a procedure on the patient tissue. The system further includes a second moveable support structure coupled between the coupling member and the surgical instrument. The second moveable support structure includes one or more actuators which may be controlled to electromechanically characterize movement of the surgical instrument relative to the coupling member.

Abstract: A method of compensating for motion of objects during a surgical procedure is provided. The method includes determining a pose of an anatomy of a patient; determining a pose of a surgical tool of a surgical device; defining a relationship between the pose of the anatomy and a position, an orientation, a velocity, and/or an acceleration of the surgical tool; associating the pose of the anatomy, the pose of the surgical tool, and the relationship; and updating the association in response to a motion of the anatomy and/or a motion of the surgical tool without interrupting operation of the surgical device during the surgical procedure.

Abstract: The invention relates to a method of relating a position (pos(selected)) of an anatomical structure (3) and a position of an image feature representing the anatomical structure in a medical image (11), the method being constituted to be executed by a computer and comprising: a) acquiring information about the position of a medical imaging apparatus (1) at the beginning (pos(start)) and at the end (pos(end)) of acquiring medical image information describing a medical image (11) of at least a part of a patient's body (2) comprising the anatomical structure (3), wherein the medical imaging apparatus (1) is moved while it is used for acquiring the medical image information; b) acquiring imaging information about a relationship between the movement of the medical imaging apparatus and the acquisition of the medical image information; c) acquiring, based on the position of the medical imaging apparatus at the beginning (pos(start)) and at the end (pos(end)) of acquiring the medical image information, information ab

Abstract: An apparatus includes a reference fixture. The reference fixture includes a joint, and a joint tracker to track motion of the joint. The apparatus also includes a surgical instrument. A tether is connected between the joint and the surgical instrument. A shape sensor extends from the reference fixture through the joint, through the tether, and into the surgical instrument. The shape sensor is substantially free of twist. The joint tracker measures the motion of the joint. Information from the shape sensor in combination with information from the joint tracker provides absolute three-dimensional information relative to the reference fixture, i.e., provides absolute three-dimensional information in a fixed world reference frame.

Abstract: A surgical controlling system comprising: means to real-time locate the 3D spatial position of at least one surgical tool insertable into a surgical environment of a body, in communication with a movement detection means and a movement database; and a controller in communication with a controller database and the movement detection means. The movement database stores 3D spatial positions of surgical tools at times tf and t0; it has moved if its 3D spatial position at time tf differs from that at time t0. Rules stored in the controller database determine ALLOWED and RESTRICTED movements of surgical tools and are used to control the surgical tools' spatial positions. Rules include: most used tool, right tool, left tool, field of view, no fly zone, route, environmental, operator input, proximity, collision prevention, history-based, tool-dependent ALLOWED and RESTRICTED movement, preferred volume zone, preferred tool, movement detection, tagged tool, and change of speed rules.

Abstract: Robotic and/or surgical devices, systems, and methods include kinematic linkage structures and associated control systems configured to facilitate preparation of the system for use. In some embodiments, actively driven joints will move a platform structure that supports multiple manipulators in response to movement of one of the manipulators, facilitating and expediting the arrangement of the overall system by moving those multiple manipulators as a unit into alignment with the workspace. Systems and methods are also provided to keep one, some, or all joints of the kinematic chain off a hardstop or physical range of motion limit associated with the joint or to otherwise maintain a desired range of motion for one, some, or all joints of the kinematic chain when exiting a set-up mode.

Abstract: A surgical system includes a plurality of voice sensors located in a surgical environment and configured to detect sound and generate a first plurality of signals. The surgical system also includes a position indicator, in proximity to a designated user, configured to indicate a first position of the designated user and generate a second signal representative of the first position. The surgical system further includes a processor configured to receive the first plurality of signals and the second signal and determine, based on the first plurality of signals, a second position. The processor is also configured to compare the detected sound with registered voice command of the designated user stored in a memory to verify the designated user's credentials, and send a command signal to a surgical instrument to carry out an operation related to the voice command based on at least one of the verification of the designated user's credentials, the first position and the second position.

Abstract: A surgical implement and a manipulation system including the surgical implement may include at least one instrument including at least one joint portion. The joint portion may include a first part, a second part connected to the first part, and a force applying element for applying a force for bending (or rotating) the second part. A distance between a joint point and a force application point where a force is applied may be greater than a diameter of at least one of the first part and the second part. The instrument may further include a second joint portion spaced apart from the joint portion, and a surgical tool connected to an end portion of the second joint portion. The manipulation system may include a supporting structure, at least one instrument supported by the supporting structure, and an operating device for operating the instrument.

Abstract: An operational feeling reproduction device includes an operation component, an actuator, and a drive shaft. The actuator generates a haptic drive force in response to operation of the operation component. The drive shaft couples the operation component and the actuator. The haptic drive force is transmitted to the operation component through the drive shaft in response to the operation of the operation component such that an actual operational feeling is experienced. The actuator has a stationary element and a movable element. The actuator generates the haptic drive force by a relative displacement while one of the stationary element and the movable element is inserted into the other one of the stationary element and the movable element. The movable element and the operation component are coupled by the drive shaft. Center axes of the stationary element, the movable element, and the drive shaft are provided on the same axis.

Abstract: An aseptic medical instrument packaging has supporting peelable flaps by adding a material playing a supporting role which is harder than the rest of an extending part outside a sealing edge of a peeling side of the packaging, or adopting a material which is harder than the rest of an extending part outside a sealing edge of the peeling side of the packaging. A groove is carved in a junction between an outer edge of a sealing edge of a peeling side of the packaging. The material playing the supporting role comprises hard plastic, metal and paper. A soft cover of the packaging is prevented from being curled inwardly in the process of peeling open the packaging; and when one or two peeling sides exist, the degree of differentiation the peeling side will be increased, such that medical staff can conveniently find the peeling side.

Abstract: A single use disposable surgical kit, including a sterile sealed container including a module configured to fit within the sterile sealed container including surgical instruments housed in a bottom tray including a first fastening feature; and a lid including a second fastening feature congruently aligned with the first fastening feature, wherein the first fastening feature is one of a tab portion and a mating slot, the second fastening feature is the other of the tab portion and the mating slot, and the second fastening feature is configured to engage with the first fastening feature.

Abstract: A surgical instrument including a handle assembly, an elongated portion, an end effector, and a stop member is disclosed. The end effector is disposed adjacent a distal portion of the elongated portion and includes a first jaw member and a second jaw member. At least one jaw member is movable with respect to the other jaw member between spaced and approximated positions. The first jaw member includes an upper tissue-contacting surface and a lower shelf portion. The shelf portion includes a groove disposed therein. The stop member is disposed adjacent a distal portion of the first jaw member and is pivotable with respect to the first jaw member between a first position, a significant portion of the stop member being positioned external to the first jaw member, and a second position where a lower portion of the stop member being positioned at least partially within the groove.

Abstract: A thickness gage including a transparent measurement tube configured to receive and be slidingly engaged over a tubular shaft of a retrograde reamer. The tubular shaft has linear graduation marks on its surface for identifying linear measures for use in measuring a thickness of a bridge bone gap. The linear graduation marks are located on the tubular shaft surface such that at least some of the linear graduation marks can be observed through the transparent measurement tube. Each linear graduation mark, when aligned with a proximal end of the measurement tube, provides a linear measure of the distance between a distal end of the measurement tube and a cutting member of the retrograde reamer positioned so that its central axis is disposed at a non-zero angle relative to a longitudinal axis of the tubular shaft. Such a distance corresponds to the thickness of the bridge bone gap.

Abstract: An offset reference guide for use in determining an offset value for orthopedic fasteners to be used with surgical hardware. The reference guide may include a reference surface against which the surgical hardware may be disposed. In turn, an orthopedic fastener may be inserted through a fastener hole of the surgical hardware and accepted by a fastener relief of the guide. Upon fully seating the orthopedic fastener relative to the surgical hardware, the distal end of the orthopedic fastener may align with one of a set of offset indicia calibrated relative to a known length of the orthopedic fastener. In turn, an offset value for the surgical hardware may be determined that may, for example, be used to augment measurements of bore lengths taken for a bore into which an orthopedic fastener is to be disposed.

Abstract: Devices and methods are described for performing a procedure on multiple adjacent segments of a body surface. The methods generally involve positioning a locator device on a body surface to delineate a first body surface segment. A first portion of the locator device may be moved while leaving a second portion of the locator device in place as a reference. The second portion of the locator may then be moved to reform the locator device and delineate a second segment of the body surface. Locator devices comprising two detachable portions are also described.

Abstract: A tool setting device includes a base body having longitudinally opposite base top and bottom surfaces laterally bounded by at least one base side surface. At least one setting aperture extends from the base top surface longitudinally downward at least partially through the base body. An elongate setting support slidably fits into a corresponding setting aperture. The setting support includes indicia and a tool engaging feature. A support holding feature is provided for maintaining a longitudinal position of the setting support with respect to the setting aperture. The tool engaging feature is positioned at a predetermined longitudinal distance above the base top surface. The predetermined longitudinal distance bears a direct relationship to the indicia. The tool engaging feature is maintained at the predetermined longitudinal distance through engagement of the setting support with the support holding feature. A method of transferring numerical setting information to a tool is also provided.

Abstract: A method for producing a one-piece orthodontic jig and attachments employs a computer-aided design (CAD) system to create a model of a patient's dental anatomy. A set of orthodontic attachments and their desired positions are also designed in the CAD model. An orthodontic jig for temporarily positioning the attachments during the bonding process is then designed that includes features for registering the jig to selected teeth, together with connecting members that detachably connect the attachments to the jig and hold the attachments in their desired position on the patient's teeth during the bonding process. The orthodontic jig and attachments is fabricated as a single piece by computer-controlled manufacturing (e.g., 3D printing) based on the CAD model.

Abstract: The present invention addresses the problem of providing an orthodontic retainer with which there are no aesthetic concerns and smooth pronunciation during conversation is possible, and which is able to secure favorable fitting and can be worn for long periods. The retainer is configured so that, by being fitted so as to surround the entire dental arch (T) of the maxilla (A) or the mandible and by the inner surface being fitted, on the front and back surfaces of the entire dental arch (T), with a specified vertical width (H) that encompasses the cervical sections (T1, T2) of said teeth, a retaining force is applied on a portion of the crown (T3) of each tooth from the front and back surfaces.

Abstract: Various embodiments of an orthodontic appliance are provided. In one embodiment, an orthodontic appliance is provided, the appliance comprising: a body; at least one ring-shaped member connected to the body via at least one connecting portion; wherein the body and the at least one ring-shaped member are oriented adjacent to one another; and wherein the body and the at least one ring-shaped member are not coplanar when in an unloaded state.

Abstract: The dental appliance-holding bracket assembly includes a plurality of housings attached to a corresponding tooth band, each of the tooth bands being cemented to the crown of an adjoining tooth. Each housing defines a socket of a ball-and-socket joint. The assembly further includes a plurality of bracket arms, each bracket arm having a shank including a proximal end and an opposing distal end. The proximal end of the shank has a ball pivotally captured within the housing socket to form a ball-and-socket joint, while the opposing distal end of the shank includes a ring adapted for supporting a dental appliance.

Abstract: The invention discloses a tray system and a method for preparing such tray system. The tray system including a tray with a base having holding arrangements for holding implant components, instruments and/or instrument holders, at least a first and a second information sheet which both are adapted to be independently removably arranged on said base of said tray. Each information sheet has its own distribution of holes, which are placed in register with the holding arrangements of the base when the information sheet is arranged on the base, so that an implant component, instrument or instrument holder is arrangable into one of said holing arrangements through a respective one of said holes.

Abstract: The invention relates to a porous dental milling block comprising at least two geometrically defined Material Sections A and B, Material Section A comprising a tetragonal zirconia crystal phase in an amount A-T in % and a cubic zirconia crystal phase in an amount A-C in %, Material Section B comprising tetragonal zirconia crystal phase in an amount B-T in % and cubic zirconia crystal phase in an amount B-C in %, wherein (amount of tetragonal phase A-T in %)/(amount of cubic phase content A-C in %)>1 and (amount of tetragonal phase content B-T in %)/(amount of cubic phase content B-C in %)<1. The invention also relates to a process of production of the porous dental milling block and its use for producing a dental article.

Abstract: A method of capturing data from a patient's dentition with the steps of positioning a first optical sensor relative to patient's dentition, capturing the shape of a tooth in the patient's dentition, independent from capturing the shape, measuring a color at a location on the tooth, and providing a correlation between the location of the color and a coordinate in the captured shape. The invention helps providing a dental restoration at a relatively high optical, mechanical, and geometric quality.

Abstract: The system includes a reservoir for fluid; a droplet generator for creating a stream of fluid droplets from the fluid wherein the velocity of the stream of droplets is within a range of 20 meters per second to 200 meters per second and the size of the droplets is within a range of 5 microns to 200 microns. A nozzle or nozzles direct the stream of droplets to safely clean a selected tooth or teeth surface area. The specific momentum of effective fluid droplets within the stream of fluid droplets is important in safe and effective cleaning.

Abstract: An implantable girth control device for controlling urinary incontinence by placing the device around the urethra. The device comprising an adjustable resilient circumferential collar comprising a strap for embracing the urethra, the strap having two inflatable/deflatable expandable members, the first expandable member is a fluid filled expandable member that is affixed to an inner portion of the strap and in contact with the urethra, the second expandable member is affixed to an outer portion of the strap and is in fluid communication with the first expandable member over a valve. The valve is configured facilitate fluid transfer between the two members in response to changes in urethral pressure and to control a collar pressure applied by the device onto the urethra.

Abstract: Implant systems and methods are provided to include a treatment material with a pelvic implant device. The pelvic implant device, such as an incontinence sling, can include the treatment coating combination of a material, such as Phosphorylcholine (PC), and an infection prevention material, such as InhibiZone® (IZ) technology. The treatment material can be coated onto, or impregnation or integrated with, polypropylene mesh in order to prevent infection and promote healing.

Abstract: This invention generally relates to a device and method for repairing biological tissue aperture. In certain embodiments, the invention provides a system for closing an aperture in a biological tissue that includes a handle, a shaft connected to the handle, and a deployment scaffold connected to the shaft, in which the scaffold is configured to releasably retain a surgical implant and the scaffold includes an open configuration and a closed configuration, the open configuration being substantially X-shaped.

Abstract: The present invention relates to a prosthesis (1) intended to be implanted at an implantation site, comprising means of information (5) intended to guide the surgeon for performing the implantation of the prosthesis according to a defined arrangement, said prosthesis comprising at least one porous textile (2) having two faces (3,4) separated by a certain thickness, said means of information comprising at least one seam (5) provided in said textile, said seam traversing the thickness of said textile from one face to the other of said textile while preserving said thickness of said textile, said seam defining a zigzag pattern on at least one face of the textile.

Abstract: Articles and procedures for preventing or treating vaginal prolapse, urinary incontinence, and other disorders of the pelvic floor.

Abstract: A unitary or homogeneous patterned implant is provided. The implant is constructed of patterned cells formed by way of a molding, die casting, laser etching, laser cutting, extruding, and the like. Portions of the implant can be formed into sinusoid or other waveform strut members to control and promote elongation, expansion or contraction along single or multiple axes. As such, controlled and designated stress, tension and compression distribution is promoted across specific or localized areas of the implant.

Abstract: Absorbable implants for breast surgery that conform to the breast parenchyma and surrounding chest wall have been developed. These implants support newly lifted breast parenchyma, and/or a breast implant. The implants have mechanical properties sufficient to support a reconstructed breast, and allow the in-growth of tissue into the implant as it degrades. The implants have a strength retention profile allowing the support of the breast to be transitioned from the implant to regenerated host tissue, without significant loss of support. Three-dimensional implants for use in minimally invasive mastopexy/breast reconstruction procedures are also described, that confer shape to a patient's breast. These implants are self-reinforced, can be temporarily deformed, implanted in a suitably dissected tissue plane, and resume their preformed three-dimensional shape. The implants are preferably made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof.

Abstract: Systems, devices and methods are presented for embolic protection. In some embodiments, a device for implantation in a patient's vessel containing a fluid flow is provided which comprises proximal and distal ends, an undeployed, substantially linear state, and a deployed, spring-like (helical) state comprising windings. When the device is deployed, the line segment connecting the proximal and distal ends is approximately perpendicular to the majority of the windings and to the fluid flow. In some embodiments, a delivery device for the monofilament device is provided. The delivery device comprises a needle having a lumen, a sharp distal end, and a pusher slidable within the needle. A method for deploying the monofilament device using the delivery device is provided.

Abstract: An intravascular filter device having a flexible arm which comprises a portion of an alarm system for detecting filling or plugging of the filter by captured emboli is described. The flexible arm may be made of ferromagnetic material, a magnet, or have at its tip a magnet which, as it moves under systolic and diastolic pressures, generates a signal detectable by an electrical sensor or a magnetometer. The signals from each of a pair of artery filters may be measured and compared to determine whether one filter is plugged. A system for detection and a method of use are also provided.

Abstract: A device for implantation into the heart of a mammal and a method for treating tricuspid regurgitation using the device. The device includes two tubular stent members separated by a stent graft member which has a functional stented valve member attached thereto allowing unidirectional blood flow from the vena cava into the right atrium.

Abstract: A foldable intraocular lens for providing vision contains an optic body that includes an optical zone and a peripheral zone entirely surrounding the optical zone. The optic body has an anterior face, a substantially opposing posterior face, an optic edge, and an optical axis. The anterior face comprises a central face, a peripheral face, and a recessed annular face therebetween that is disposed posterior to the peripheral face. The intraocular lens further comprises at least one haptic that is integrally formed with the peripheral zone. The haptic comprises a distal posterior face, a proximal posterior face, and a step edge disposed at a boundary therebetween. The haptic further comprises a side edge disposed between the optic edge and the step edge. The proximal posterior face and the posterior face of the optic body form a continuous surface. An edge corner is formed by the intersection of the continuous surface with the optic edge, the side edge, and the step edge.

Abstract: An intraocular lens includes a lens capsule expanding device and an optical portion. The lens capsule expanding device includes a front supporting portion to make contact with an inner surface of an anterior capsule. A rear supporting portion provided on a rear side of the front supporting portion makes contact with an inner surface of a posterior capsule while facing the front supporting portion. A connecting portion connects the front supporting portion and the rear supporting portion so as to have biasing force in a direction of separating the front supporting portion and the rear supporting portion from each other. Due to the biasing force, the front supporting portion presses the inner surface of the anterior capsule and the rear supporting portion presses the inner surface of the posterior capsule. The optical portion changes the curvature of a central portion according to movement of the connecting portion.

Abstract: Modular IOL systems including a base and a lens, wherein the lens includes tabs for connection to the base. The modular IOL allows for the lens to be adjusted or exchanged while leaving the base in place, either intra-operatively or post-operatively.

Abstract: Apparatuses, systems and methods for providing improved intraocular lenses (IOLs), include features for reducing side effects, such as halos, glare and best focus shifts, in multifocal refractive lenses and extended depth of focus lenses. Exemplary ophthalmic lenses can include a continuous, power progressive aspheric surface based on two or more merged optical zones, the aspheric surface being defined by a single aspheric equation. Continuous power progressive intraocular lenses can mitigate optical side effects that typically result from abrupt optical steps. Aspheric power progressive and aspheric extended depth of focus lenses can be combined with diffractive lens profiles to further enhance visual performance while minimizing dysphotopsia effects. The combination can provide an increased depth of focus that is greater than an individual depth of focus of either the refractive profile or the diffractive profile.

Abstract: The present disclosure is directed to embodiments of catheter-based prosthetic heart valves, and in particular, prosthetic heart valves having sealing devices configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted. In one embodiment, a prosthetic heart valve includes an annular sealing member that can be placed in a delivery orientation extending axially away from one end of the valve when the valve is in a radially compressed state. When the valve is expanded, the expansion of the frame causes the sealing member to be pulled to an operative orientation covering a portion of the frame. The present disclosure also discloses new mechanisms and techniques for mounting valve leaflets to a frame of a prosthetic heart valve.

Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an expandable support having an outer surface and configured for placement between leaflets of the native valve. The device can also include a plurality of asymmetrically arranged arms coupled to the expandable support and configured to receive the leaflets of the native valve between the arms and the outer surface. In some embodiments, the arms can include tip portions for engaging a subannular surface of the native valve.

Abstract: Methods and apparatus for holding and maneuvering a valve during preparation and attachment to patient, providing increased visibility of the prosthetic valve and the sewing ring to prevent suture entanglement. A handle attachment is spaced from the valve for improved visibility of the sewing ring and the outlet end of the valve during attachment. Commissure posts are bent inward at the tips while preventing crashing of the commissure posts into each other causing damage. A release force needed to remove the holder and unthread the holder sutures is reduced. The holder and related methods can provide a kink free holder suture path to reduce suture entanglement and prevent damage to the implanted valve during holder removal by reducing the release force needed to remove the holder sutures by up to 30%.

Abstract: An implantation device for a prosthetic heart valve includes a valve holder for maintaining the prosthetic heart valve in a closed configuration and at least one protective sheet coupled to the valve holder, the at least one protective sheet being configured to cover a leaflet of the heart valve during implantation.

Abstract: A delivery device for a collapsible prosthetic heart valve includes a support shaft around which a compartment for the valve is defined, a distal sheath adapted to selectively cover and uncover the compartment and the valve, and a marker cage having a collapsed condition when the distal sheath covers the compartment and an expanded condition when the compartment is uncovered. The marker cage includes at least one rib having a radiopaque marker for determining the positioning of the valve as it is deployed. The valve may be assembled around the marker cage so that the marker cage does not interfere with the radial expansion of the valve during deployment.