Abstract: 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.

Abstract: It is provided a cardiac valve prosthesis, obtainable by a method comprising the following steps: a) providing human or animal body tissue, b) shaping the body tissue in a shaping process to give the body tissue a shape and size of a cardiac valve, c) fixation and stabilization of the body tissue by a cross-linking agent, thereby preserving the shape given to the body tissue by the shaping process and thus obtaining a cardiac valve prosthesis. In this context, the cross-linking agent comprises at least one compound having a structure according to general formula (I).

Abstract: A method of manufacturing a prosthetic heart valve includes coupling a plurality of prosthetic leaflets to each other, and coupling the plurality of prosthetic leaflets to a cuff, to form a valve assembly. The valve assembly may be coupled to a stent to form the prosthetic heart valve. The valve assembly may be formed prior to the plurality of prosthetic leaflets being coupled to the stent and prior to the cuff being coupled to the stent.

Abstract: A replacement heart valve device is disclosed. In some embodiments, the device includes a frame coupled to one or more leaflets that are moveable between open and closed configurations. In some embodiments, the frame comprises at least two frame sections that join at a pair of commissural posts. In some embodiments, the device may be geometrically accommodating to adapt to different vasculature shapes and sizes and/or to be able to change size while implanted within a growing patient.

Abstract: 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.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example system includes an inner shaft having proximal and distal end regions and a first coupling member disposed along the distal end region, wherein the first coupling member includes a first projection and a first recess. The system also includes a support shaft having proximal and distal end regions and a second coupling member disposed along the proximal end region, wherein the second coupling member includes a second projection and a second recess. The system also includes a locking collar coupled to the inner shaft. Additionally, coupling the inner shaft to the support shaft includes placing at least a portion of the first projection into the second recess, placing at least a portion of the second projection into the first recess and positioning the locking collar along a portion of both the first and second coupling members.

Abstract: Systems, devices, and methods for treating a diseased native valve in a patient, the system comprising a compressible and expandable frame structure and an anchor. The anchor comprises a wire having a free end and is configured to be fully advanced from an atrial side of a native valve in a patient into a ventricle of the heart and anchor the frame structure to the native valve when the frame structure is in the expanded configuration adjacent the native valve.

Abstract: A catheter device for implanting a medical implant has a handle that includes a locking element configured to be moved from a first to a second state. The locking element limits a movement of a traveler and therewith of a capsule in a distal direction (D) in the first state. The locking element allows further movement of the traveler and therewith of the capsule in the distal direction in the second state.

Abstract: 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.

Abstract: Devices are disclosed for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the mitral valve and an edge to edge device. Methods are disclose for reducing mitral valve regurgitation at low left ventricle pressure and high left ventricle pressure during the cardiac cycle. Devices are disclosed for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the mitral valve with an adaptive coaptation element.

Abstract: 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.

Abstract: A leaflet restraint (20) includes a non-blood-occlusive net (30), which is configured to at least partially cover an atrial surface (32) of a single native cardiac leaflet (34) of a native atrioventricular valve (36) of a heart (38). Two or more tissue-penetrating annulus anchors (40) are fixed to an annular side (42) of the net (30), and are configured to be anchored to an annulus (44) of the native atrioventricular valve (36) along or within 1 cm of a portion of the annulus (44) to which the single native cardiac leaflet (34) attaches. A ventricular anchor (50) is configured to be anchored to a ventricle (54) of the heart (58) so as to anchor a ventricular end (52) of the net (30) to the ventricle (54). The leaflet restraint (20) is configured, when anchored in place at least partially covering the atrial surface (32) of the single native cardiac leaflet (34), to limit prolapse of the single native cardiac leaflet (34) into an atrium (56) of the heart (38). Other embodiments are also described.

Abstract: An annuloplasty device is disclosed for treating a defective mitral valve having an annulus, comprising a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into the CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state, the displacement unit comprises a proximal reversibly expandable portion, a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape, wherein the proximal expandable portion is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS, and wherein the distal anchoring portion comprises an inflatable unit.

Abstract: An orthopedic implant has an implant body defining a longitudinal axis extending in a direction of implantation of the orthopedic implant, the implant body having a first end portion and a second end portion. A porous structure extends circumferentially around the implant body and has a first circumferentially-extending zone exhibiting a first coefficient of friction with bone tissue and a second circumferentially-extending zone exhibiting a second coefficient of friction with bone tissue, wherein the second coefficient of friction is greater than the first coefficient of friction. The first circumferentially-extending zone of the porous structure is offset from the second circumferentially-extending zone along the longitudinal axis such that during implantation of the orthopedic implant, the first circumferentially-extending zone of the porous structure contacts bone before the second circumferentially-extending zone of the porous structure.

Abstract: An orthopaedic prosthetic component includes a manufactured acetabular shell component having an outer wall and an additively manufactured augment coupled to the outer wall. The augment includes an outer surface that defines a customized patient-specific negative contour shaped to conform to a positive contour of a patient's bone. A method for manufacturing the prosthetic component is also disclosed.

Abstract: The invention relates to a medical implant (10) comprising an implant body (12) comprising a polymer material. The implant body has a bone-facing interface (14) and an articulating interface (16). A stiffening layer (18) is provided over at least a portion of the bone-facing interface. The stiffening layer is porous and is formed of a material having a higher stiffness than the polymer material of the underlying bone-facing interface.

Abstract: Provided is an elbow joint prosthetic implant (100) comprising: a humeral component (50) comprising a humeral stem portion (60) configured for placement within the humeral intramedullary canal of a subject, an ulnar component (110) comprising an ulnar stem portion (120) configured for placement within the ulnar intramedullary canal of the subject, wherein the humeral component (50) and ulnar component (110) are connected by an implant elbow joint (130), wherein the ulnar component (110) further comprises an angulation joint (140) that is separate from the implant elbow joint (130), wherein the angulation joint (140) and has at least one degree of freedom of rotational movement configured to adjust and fix a varus-valgus direction of the ulnar stem portion (120).

Abstract: A patient specific shoulder guide is provided that includes a hub and a plurality of peripheral members. Each of the peripheral members has a peripheral member height dimension between the patient specific contact surface and a side of the peripheral member opposite the patient specific contact surface. At least one of the peripheral members is a low profile peripheral member in which the peripheral height dimension is less than the peripheral height dimension of at least one other of the peripheral members or is less than the hub height.

Abstract: A subtalar joint implant system that includes a first implant component and a second implant component is disclosed herein. An alternative embodiment of a subtalar joint implant system is disclosed and includes a first component that has threads disposed on at least a portion of an exterior surface of the first component and a second component having threads disposed on at least a portion of the exterior surface of the second component. The first and second components are each configured to couple with at least a portion of a talus and a calcaneum of a patient with the first component being configured to couple with at least a portion of a posterior facet of the calcaneum of the patient and the second component being configured to couple with at least a portion of a middle facet of the calcaneum of the patient.

Abstract: Disclosed are systems, devices, methods and surgical procedures for altering and/or correcting the alignment of adjacent bones, including bones of the spine.

Abstract: Disclosed are devices, system and methods for spinal implants to be deployed into an intervertebral space between adjacent vertebrae to replace the function of the intervertebral disc and the facets, while restoring stability, flexibility, coronal alignment/balance, sagittal alignment/balance and proper biomechanical motion.

Abstract: A system for surgical registration. The system may include at least one computing device in communication with a surgical navigation system and the surgical device. The at least one computing device: a) receiving external bone registration data corresponding to locations on the exterior surface of the femur; b) calculating a first registration transform based on the external bone registration data; c) transforming a first bone removal plan of a surgical plan to the operative coordinate system based on the first registration transform; d) receiving internal bone canal registration data corresponding to at least one of location or orientation data from the inner canal of the femur; e) calculating a second registration transform based on both of the external and internal bone canal bone registration data; and f) transforming a second bone removal plan of the surgical plan to the operative coordinate system based on the second registration transform.

Abstract: Methods, devices and systems for the planning and execution of computer-assisted robotic surgery are provided. The methods include methods to collect information about bones and prostheses, use the information to create virtual models and simulations, optionally receive input based on user discretion in generating the cut file, and to generate instruction for the execution of cut paths during the surgery. The system and devices include computers and peripherals and set-ups to link the components together into functional systems.

Abstract: Tibial implants, instruments, systems, and methods of implanting a tibial tray during a knee arthroplasty. The inserter instrument may include a main body with a pair of fixed posterior tabs, a moveable anterior tab body with an anterior tab, and a rotatable shaft for controlling movement of the anterior tab body. When the shaft is rotated, the anterior tab body is translated into an expanded position to lock the inserter to the tibial tray, thereby providing precise positioning of the tibial tray during implantation.

Abstract: Disclosed are devices, systems and methods for restoring spinal alignment and/or maximizing range of motion for patients who suffer from spinal degenerative disorders.

Abstract: Systems and methods to evaluate a joint implant device are provided. The joint implant device can include a socket that at least partially receives a first joint component. The joint implant device can include a socket housing coupled with the socket. The joint implant device can include a first sensor, a second sensor, and a third sensor each disposed between the socket and the socket housing. The joint implant device can include a socket extension coupled with the socket. The joint implant device can include a socket housing extension coupled with the socket housing. The joint implant device can include a fourth sensor disposed between the socket extension and the socket housing extension. At least three of the first sensor, the second sensor, the third sensor, or the fourth sensor can detect a force between the socket and the first joint component.

Abstract: An intraoperative surgical system for knee arthroplasty may be configured and/or reconfigurable to allow the surgical system to be inserted into different sized joint spaces during a surgical procedure. For example, the surgical system may include a sensor support body defining a platform, a force sensor, and a plurality of sensor covers each being configured to be detachably attached to the sensor support body. Each of the sensor covers can vary from each other in at least one characteristic. A selected one of the sensor covers can be placed over the platform, sandwiching the force sensor between the platform and sensor cover, to define a joint insertion block configured to be inserted into a tibiofemoral joint for measuring a force between a tibia and a femur defining the tibiofemoral joint.

Abstract: Systems and techniques can be provided to generate sensorized insights into the characteristics of a knee joint space during a knee replacement procedure. In some implementations, a sensor support body carrying one or more sensors can be used to measure and inform the clinician of the varus/valgus angles of the tibia and femur, allowing the clinician to adjust the surgical procedure to accommodate the measured angles. The clinician may simulate changes to the load balance across the knee joint in response to potential dimensional changes to the knee joint prior to actually surgically implementing the changes.

Abstract: A system and method may be used to evaluate soft tissue. A hip joint evaluation may use an adjustable spacer, such as varying sized physical spacers or an inflatable bladder, along with a sensor to measure force, pressure, gap distance, or the like, for example during a range of motion test. A method may include using a maximum pressure during the range of motion test to determine a maximum pressure during the range of motion test. The maximum pressure may be output for display on a user interface.

Abstract: Prosthetic feet that allow for heel height adjustment and/or provide metatarsal joint functionality to more closely mimic natural human feet are provided. A prosthetic foot can include an ankle module having a locking mechanism configured to lock the heel at a particular height. The prosthetic foot can also include a toe region that adapts to varying heel heights. The ankle module and/or locking mechanism can be adjusted, controlled, and/or locked via a hydraulic mechanism. The toe region can curve upward relative to a portion of the foot proximal of the toe region.

Abstract: The present invention relates to an implant for implanting in a body, in particular in a hollow organ or a vessel of a body, the implant being composed of a filament which comprises at least one polymeric matrix material in which a magnetically heatable filler is arranged, the filament having a cross section with a core-sheath structure characterized in that the core forms a polymeric reinforcing structure, and in that the sheath comprises the polymeric matrix material in which the magnetically heatable filler is disposed, the loading of the filler being greater in the sheath than in the core.

Abstract: The disclosure relates to a stent, in particular for treating carotid artery diseases, including a tubular braided mesh made of wires which are each helically wound about a longitudinal axis of the braided mesh and cross over and under one another. In an idle state, the braided mesh has a proximal cylindrical portion and a distal cylindrical portion which are connected to one another via a transition portion, wherein the proximal cylindrical portion has a different cross-sectional diameter and a different porosity compared to the distal cylindrical portion.

Abstract: A crimper for altering an implantable medical device from an uncompressed state to a compressed state. The crimper includes a plurality of crimper elements that define a crimper channel, each of the crimper elements including a non-planar surface that forms a portion of the crimper channel. Each non-planar surface is configured to apply non-uniform radial compression along a length of the implantable medical device during operation of the crimper when altering the implantable medical device from the uncompressed state to the compressed state. The crimper also includes handle configured to operate the crimper. Actuation of the handle decreases a volume of the crimper chamber to transition the implantable medical device from the uncompressed state to the compressed state.

Abstract: A stent delivery system (100) includes a first outer sheath (111) configured to surround a first stent (110); and a second outer sheath (121) configured to surround a second stent (120).

Abstract: The delivery device includes: a first outer tube member; an inner tube member that is inserted into the first outer tube member; a second outer tube member that is positioned at a proximal side with respect to the first outer tube member and is connected to the inner tube member; a pulling member that is inserted into the second outer tube member and is connected to the first outer tube member; a first joint member in which a first hole for fixing the pulling member therein and a second hole configured to allow the inner tube member to advance and retract are formed; and a fixing member that fixes the first joint member to the first outer tube member.

Abstract: The disclosure provides a biodegradable device, administered to a patient in a compact ingestible encapsulated form. The device is self-expandable in the stomach upon contact with liquid, to assume an expanded, voluminous configuration within the stomach. The devices have a folded configuration in which intake is facilitated by the patient, and are designed to unfold and self-expand in the stomach after intake due to expansion of a plurality of expandable zones that comprise one or more gel-forming materials. The disclosure provides such devices, methods of their manufacture, as well as base units thereof.

Abstract: Methods, devices and systems for delivering a device assembly into a gastric or other space within the body, allowing the device to expand to occupy volume within the gastric space and, after an effective period of time, delivering a substance or stimulus to begin breakdown of the expanded device so that it may release from the body.

Abstract: An orthosis for increasing range of motion of a joint applies a dynamic stretch to the joint in either extension or flexion. The orthosis includes ones or more dynamic force mechanisms configured to apply dynamic stretch to one or more body portions of the body joint. The dynamic force mechanism includes a resilient force element. The dynamic force mechanism applies a dynamic extension force to the body portion when an actuator mechanism is operated to transmit an extension force to the dynamic force mechanism. The dynamic force mechanism applies a dynamic flexion force to the body portion when the actuator mechanism is operated to transmit a flexion force to the dynamic force mechanism.

Abstract: An apparatus is described that involves a harness with attached, adjustable resistance elements. In one example of the apparatus of the present invention, the resistant elements provide resistance to various user body parts, such as, for example, user limbs, glutes, chest, back and/or core, and accordingly, passive exercise accompanies normal movement of the user. The apparatus may be useful for various functions when a user is going about the routine tasks and activities of daily life, and/or may be useful for creating or supplementing user exercise plans. The apparatus may also be useful for promoting posture correction.

Abstract: The present disclosure provides a device for controlling one or more curve angles of scoliosis. The device includes a holding module and a weight module. The holding module is configured to be worn on the front-of-chest position of a user, and the holding module is provided with weight-hanging site. The weight module is suspended naturally on the weight-hanging site, and a weight-load of the weight module unit is configured to keep one or more curve angles of scoliosis of the user within a pre-defined range.

Abstract: A kit (1500) for negative pressure and immobilization therapy includes a negative pressure dressing (100) configured to define a sealed volume between a patient's skin and the negative pressure dressing when applied to the patient, a pump (200) configured to be placed in pneumatic communication with the negative pressure dressing and operable to displace air from the sealed volume, and a heat-moldable splint (900). The heat-moldable splint includes a plurality of flexible tubes formed of a first material and coupled together to form a web and a second material positioned in the flexible tubes and having a lower softening or melting point than the first material.

Abstract: Provided herein are devices, systems, and methods configured to alleviate erectile dysfunction and other health conditions by using an erectile dysfunction device, including by more effectively preventing outwards blood flow away from the penis while more effectively allowing inward blood flow into the penis to aid in erection initiation, maintenance, and stamina. The disclosed geometry, configuration, flexibility, and pliability of the device enable its use on flaccid or erect penises. The disclosed system comprising the penile constriction device and a band enables the system to apply an adjustable compressive force on a flaccid or an erect penis.

Abstract: A ostomy collection system and an ostomy collection device (10) including: a housing (12) formed of first and second parts, which together define a top (18), base (14) and wall (16) which enclose a collecting volume for receiving and storing waste from an ostomy appliance, the first part including the top (18) and having an inlet (30) for fluidly connecting to an outlet of an ostomy appliance so that waste from the ostomy appliance flows into the collecting volume, and the second part of the housing being disconnectable from the first part of the housing.

Abstract: The disclosure relates to a system for determining and signalling moisture propagation in an adhesive material layer of a base plate and/or a sensor assembly part for an ostomy appliance. The disclosure further relates to aspects of a base plate and/or a sensor assembly part for an ostomy appliance and its use in such a system.

Abstract: A more comfortable ostomy bag that will not irritate the skin from relative movement. The ostomy bag has a pair of flexible flat sheets of material bonded together at juxtaposed edges to form a seam. A soft outer edge outside of the seam is formed by extensions of the sheets that either remain disconnected so as to form loose flaps or are slit radially to form finger-like extensions, or both. The ostomy bag further has an inlet opening formed through one of the flat sheets.

Abstract: An undergarment can include a waistband with an internal pocket for placement of a colostomy bag therein. The waistband can completely contain the colostomy bag. A crotch strap can extend from an attached end, at a back of the undergarment, to a removable connection at the front of the undergarment. The user can easily convert the undergarment between underpants, that retain the features of holding the colostomy bag within its waist band, and a simple band for retaining the colostomy bag therein, where the crotch strap can easily fold and store about a back of the waist band.

Abstract: Examples relate to fluid collection devices, systems, and methods for collecting fluid from a wearer of the fluid collection device. The fluid collection device includes porous material disposed within a fluid impermeable barrier and a means for retaining the fluid collection device in a position for use between the legs of a wearer. A fluid collection system includes a fluid collection device operably coupled to a fluid storage container and vacuum source via one or more sections of conduit.

Abstract: An example tube with an elongated cross-section includes an inlet, an outlet downstream from the inlet, and an intermediate portion between the inlet and the outlet. The tube exhibits an elongated cross-section because at least the intermediate portion exhibits a width that is significantly greater than the thickness thereof. The elongated cross-section of the intermediate portion relative to its width allows the tube to be at least one of more flexible than or allows the intermediate portion to be positioned underneath a patient while minimizing the risk of bed sores relative to at least some conventional tubes.

Abstract: The present invention provides a packaged condom comprising a sealed package and, within the package, a condom comprising natural rubber latex and/or synthetic polyisoprene, wherein the condom comprises, on one or more surfaces thereof and in contact with the natural rubber latex and/or synthetic polyisoprene, an aqueous lubricant. The aqueous lubricant comprises a thickener and, in a total amount of from 5 to 25% by weight of the lubricant, one or more organic compounds independently selected from the group consisting of a polyhydric alcohol and a sugar, each of said one or more organic compounds having at least 4 hydroxyl groups and a molecular weight of from 120 to 10000.

Abstract: A tray for securing an implantable device to a carrier member includes a slot configured to retain the carrier member and a receptacle adjacent the slot. The carrier member surrounds a shaft of the implantable device. The receptacle has a first width at a proximal end of the receptacle to receive first and second arms of the implantable device in an initial state in which the first and second arms extend substantially perpendicularly from the shaft. The receptacle has a second width at a distal end of the receptacle for receiving the first and second arms of the implantable device in a collapsed state in which the first and second arms are folded against the shaft such that the carrier member can be slid over the first and second arms to retain the first and second arms. The second width is less than the first width.