Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a method can include advancing a distal end portion of an assembly toward a native heart valve, the assembly comprising a delivery apparatus and a prosthetic heart valve, and including one or more radiopaque markers, where one radiopaque marker is suspended within a cell of a frame of the prosthetic heart valve and aligned with a commissure of the prosthetic heart valve. The method further includes receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus, determining, based on the fluoroscopic image and the one or more radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation, and rotating the assembly until the prosthetic heart valve is in the desired rotational orientation.

Abstract: A balloon-expandable interventional valve stent has a stent body (1), a valve leaflet, and a wingspan skirt (2). The wingspan skirt (2) is disposed on the outer side of an outflow tract (4). A pull suture (5) is connected to the wingspan skirt (2). When a balloon (7) is expanded and opened, the pull suture (5) connected to the skirt on the side of an inflow tract (3) is gradually tightened in a circumferential direction under the action of expanding force of the balloon (7), so that the wingspan skirt (2) is folded in the axis direction of the stent body (1), and a portion protruding outwards in the radial direction of the stent body (1) is formed, thus covering or plugging a paravalvular leak. A wingspan skirt (2) structure is added without increasing the diameter of a delivery system.

Abstract: The present embodiments provide a medical device for implantation in a patient comprising a stent and a valve. The stent comprises a proximal region comprising a cylindrical shape having a first outer diameter in an expanded state, and a distal region comprising a cylindrical shape having a second outer diameter in the expanded state. The second outer diameter is greater than the first outer diameter. A proximal region of the valve is at least partially positioned within the proximal region of the stent, and the distal region of the valve is at least partially positioned within one of tapered and distal regions of the stent. When implanted, the proximal region of the stent and the proximal region of the valve are aligned with a native valve, and the distal region of the valve is distally spaced-apart from the native valve.

Abstract: Apparatuses, systems, and methods for prosthetic valves. Examples of prosthetic valves may be configured to anchor to an interior surface of a heart valve. Such prosthetic valves, in examples, may include a single frame that supports a plurality of prosthetic valve leaflets. In examples, multiple frames may be utilized to anchor to a heart valve and one or more of the frames may support a plurality of prosthetic valve leaflets.

Abstract: A prosthetic heart valve for replacing a native valve includes a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition. At least one runner is coupled a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.

Abstract: Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve can include an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end. The valve includes an inner skirt, where a first portion of the inner skirt extends circumferentially around the central longitudinal axis along an inner surface of the frame and a second portion of the inner skirt extends circumferentially around the central longitudinal axis outside of the frame and axially beyond the inflow end of the frame such that an inflow end of the inner skirt is positioned upstream of and is axially spaced from the inlet end of the frame. The valve includes a valvular structure including two or more leaflets, where each of the two or more leaflets are secured to the inner skirt.

Abstract: A transcatheter valve prosthesis includes a stent and a prosthetic valve. The stent includes an inflow portion, an outflow portion, and a transition portion extending between the inflow portion and the outflow portion. The transition portion includes a plurality of axial frame members, and three of the plurality of the axial frame members are commissure posts. At least two of the plurality of the axial frame members are commissure posts having a first end connected to a crown of the inflow portion and an unattached second end disposed within the outflow portion such that a pair of struts of the outflow portion intersect each commissure post at a mid-portion thereof. The prosthetic valve is configured to substantially block blood flow in one direction to regulate blood flow through a central lumen of the stent.

Abstract: A retrieval catheter for retrieving a partially deployed medical device held at the end of a catheter includes an inner shaft, an intermediate shaft and an outer shaft. The inner shaft engages the catheter in a manner that prevents translation of the inner shaft relative to the catheter. The intermediate shaft is assembled around the inner shaft and includes inner threads that engage with outer threads on the inner shaft such that rotation of the intermediate shaft translates it relative to the inner shaft and the catheter. The outer shaft is assembled around the intermediate shaft and includes a valve cover at its distal end. The valve cover is operatively connected to the intermediate shaft such that translation of the intermediate shaft translates the valve cover. Components of the medical device delivery system are disassembled from the catheter and the retrieval catheter is assembled thereover to retrieve the medical device.

Abstract: An implant delivery system for delivering a replacement heart valve implant to a native valve annulus may include an elongate shaft assembly including an implant holding portion configured to constrain a replacement heart valve implant in a radially collapsed configuration. The elongate shaft assembly includes a primary visual indicator configured to be visible under fluoroscopy with an imaging device. The elongate shaft assembly includes a secondary visual indicator configured to be visible under fluoroscopy with the imaging device when the imaging device is aligned with a reference plane associated with the native valve annulus. The secondary visual indicator is not visible under fluoroscopy with the imaging device when the imaging device is misaligned with the reference plane associated with the native valve annulus.

Abstract: An implant delivery system for delivering a replacement heart valve implant to a native heart valve may include an elongate shaft assembly including an implant holding portion configured to constrain a replacement heart valve implant in a radially collapsed configuration. The elongate shaft assembly may include a plurality of longitudinal marker elements configured to be visible under fluoroscopy with an imaging device. The plurality of longitudinal marker elements is configured to rotationally align commissure posts of the replacement heart valve implant with native valve commissures of the native heart valve under fluoroscopy with the imaging device when the replacement heart valve implant is shifted to a radially expanded configuration within the native heart valve.

Abstract: The present disclosure relates to a guard member for preventing prolapse, flail, or billow of at least one leaflet of a heart valve, and a pathology associated therewith. Specifically, the guard member is adapted, sized and configured to operably couple to the heart valve annulus and prevent a leaflet of the heart valve from extending cephalad to the heart valve's annular plane.

Abstract: A puncture locator device for use in locating a desired tissue puncture site and executing a puncture therethrough includes a handle, a tissue depressor form, and a needle channel that passes through at least a portion of the tissue depressor form.

Abstract: An implantable device includes one or more anchors. The anchors are configured to capture one or more leaflets of a native heart valve. The one or more anchors are configured to draw native valve leaflets into the device. The anchor portion can be extendable and retractable. The one or more anchors can be closed to secure the implantable device to the native valve leaflets.

Abstract: A device adapted to support an erection for a trans-male person identified as female at birth has an implantable support with a base including a first receptacle and a second receptacle. The receptacles are shaped and sized to receive an end portion of a penile prosthesis. When the base of the implantable support is attached to a pelvis of the trans-male person and the penile prostheses are inserted into the receptacles, the neophallus of the trans-male person, when erect, will be adapted for penetrative intercourse.

Abstract: Prosthetic device suitable for being implanted in a bone or joint site of the human body, including a prosthetic body, wherein the prosthetic device includes or can be added with antibiotic or a medical substance.

Abstract: A stemless humeral shoulder assembly having a base member and an anchor advanceable into the base member. The base member can include a distal end that can be embedded in bone and a proximal end that can be disposed at a bone surface. The base member can also have a plurality of spaced apart arms projecting from the proximal end to the distal end. The anchor can project circumferentially into the arms and into a space between the arms. When the anchor is advanced into the base member, the anchor can be exposed between the arms. A recess can project distally from a proximal end of the anchor to within the base member. The recess can receive a mounting member of an anatomical or reverse joint interface.

Abstract: Various embodiments of novel glenoid implant are disclosed. The glenoid implant includes: an articular body that includes an articulation surface and a bone-facing surface on opposite side of the articular body; a metal tray attached to the bone-facing surface; and one or more holes provided in the articular body extending from the articulation surface through the articular body and the metal tray to accommodate a screw therethrough. An implant system that includes the glenoid implant and a corresponding humeral head implant is also provided.

Abstract: An interspinous spacer includes a body having a channel and at least one slot; an arm actuator defining a threaded channel; an actuator screw including a shaft with a threaded distal portion partially disposed in the channel of the body and the threaded channel of the arm actuator; a first pin arranged to move along the slot of the body; a second pin; and first and second arms, each having a coupling extension that defines a pin opening and a curved track. The first and second arms are coupled to the body by the second pin extending through the curved tracks and further coupled to the body and the actuator arm by the first pin extending through the pin openings. The first and second arms rotate among different deployment positions according to the curved track in response to longitudinal movement of the actuator arm as the actuator screw is rotated.

Abstract: An intersomatic device (10), in particular for intersomatic vertebral stabilization, comprises at least two bodies (20, 30) that are reciprocally slidable in one another and cooperate so as to grow in volume in the intersomatic space until they cover an upper area of the receiving vertebral plates. An adjusting member (40) interacts with said bodies (20, 30) to define a first “compact” condition in which the device (10) and a second “extended” configuration, i.e. open and greater in volume, wherein the teeth of the first element (20) are moved and interfere minimally with those of the second element (30).

Abstract: An expandable intervertebral cage includes a first plate and a second plate opposite to the first one. The cage further comprises a movement and adjustment mechanism of the two plates suitable to promote the relative mutual translation between the first and second plate parallel to each other. The movement and adjustment mechanism comprises a single central shaft, coaxial with a central longitudinal axis of the plates and having an external thread, a proximal wedge and a distal wedge placed between the first and second plate, aligned along the central longitudinal axis and coupled to the external thread of the central shaft which is centrally inserted in the distal wedge and the proximal wedge. The movement and adjustment mechanism also comprises a first actuator and a second actuator, both provided on the central shaft and placed at the same proximal end of the cage.

Abstract: The present disclosure relates to expandable interbodies that include superior and inferior shells and a control assembly positioned between and inside of the shells, the control assembly including nested cages operably connected to each other with an adjustment screw. Rotation of the adjustment screw translates the cages relative to each other, which in turn causes the shells to open or expand.

Abstract: An implant extracting tool (100) is provided having an elongate housing (200) with a proximal end (202) configured for connection to a tool, a distal end (204) having an opening for operably engaging an implant, and an elongate recess (206) therein to the opening. A jaw (118) is slidably received within the slot and extends into the opening. A linkage assembly (280) is secured and received within the elongate recess and is pivotally secured to the jaw such that operation of the linkage slides the jaw within the slot towards and away from the opening. A lock mechanism (140) can be provided to hold the extracting tool in a locked position when clamped onto an implant.

Abstract: A method of generating a touch signal corresponding to a state of a subject, the method including, receiving, from a foot of the subject, multiple wavelength signals corresponding to an applied plantar pressure based on the state of the subject. The method further includes receiving, using channels of a BCI mounted on the subject's head, a plurality of EEG signals (brain signals) that corresponds with wavelength signals. The method further includes transmitting EEG signals to train a classifier to identify a correlation between EEG signals and wavelength signals. The method further includes selecting a subsection of channels with high correlation with wavelength signals. The method further includes forming a secondary dataset by combining the subsection of channels with wavelength signals. The secondary dataset is passed to train a ML model to generate the touch signal corresponding to the subject's state that is relayed to a lower limb prosthesis.

Abstract: In some embodiments, a sensor assembly for measuring a depth of insertion of a locking pin of a liner in a pin lock of a lower-limb prosthetic is provided. The sensor assembly comprises a base; a sensing element mounted to the base and having a hollow interior; and a housing that encloses at least the sensing element and includes means for coupling the sensor assembly to the lower-limb prosthetic in a position where the locking pin adapter of the lower-limb prosthetic is aligned with the hollow interior of the sensing clement. The sensing element is configured to generate a signal indicative of a size of a portion of the locking pin that is within the hollow interior of the sensing element.

Abstract: Embodiments include a prosthetic thumb device that includes a track configured to attach to a prosthetic socket, a carriage, and a locking mechanism. The carriage can include a first component that couples to the track such that the carriage is operable to move along the track, and a second component that is configured to couple with a prosthetic digit and operable to rotate with respect to the first component. The locking mechanism can be coupled to the carriage and configured such that, in a first state, it prevents the carriage from moving along the track in a first direction and, in a second state, it allows the carriage to move along the track in the first direction. Embodiments can also include the track having a curved profile, and the carriage is operable to move along the curved profile of the track.

Abstract: A ventilated prosthetic socket includes a rigid, structural and load-bearing socket body forming an inner volume adapted to receive a residual limb, and a wall thickness extending from an inner wall surface bordering the inner volume to an outer wall surface. The socket body defines an opening extending through the wall thickness. At least one vent element communicates the inner wall surface to the outer wall surface and extending therebetween in the opening along the socket body to thereby permit a transfer of air from the inner volume to outside of the socket through the opening. The at least one vent element is separately formed from the socket body and discretely insertable into the opening and secured against the inner surface and the outer wall surface. A method and kit are provided to adapt the socket in a ventilated form.

Abstract: An example medical device for treating a body lumen is disclosed. The medical device includes an expandable scaffold including a first end region, a second end region opposite the first end region and an outer surface. The medical device also includes a covering disposed along the outer surface of the expandable scaffold, the covering having an outer surface. The medical device further includes a plurality of granular particles disposed along the covering. Additionally, the expandable scaffold is configured to shift from a collapsed state to an expanded state, the covering is configured to contact an inner surface of the body lumen in the expanded state and the granular particles are designed to prevent migration of the expandable scaffold upon implantation in the body lumen.

Abstract: Devices and methods are described for delivering aneurysm stabilizing substances that may act in more than one pathway to the aneurysmal wall to prevent further enlargement of an aneurysm while allowing blood flow through the treatment area. Methods, devices and features for removal of the delivery device after the treatment are also disclosed.

Abstract: Stents as described herein can comprise a tubular body in which a midbody extends to a first end and also extends to an opposing second end, where the midbody includes a thread arranged helically along at least a portion of its length. The thread can exhibit various shapes and dimensions selected to enhance particular aspects of performance when the stent placed in an anatomical structure of a patient.

Abstract: A covered stent (10), including a membrane (12) and a support (11, 21, 31, 41, 51), where the membrane (12) includes a first membrane (121, 221, 321, 421, 521) and a second membrane (122, 222, 322, 422, 522); the support (11, 21, 31, 41, 51) is arranged between the first membrane (121, 221, 321, 421, 521) and the second membrane (122, 222, 322, 422, 522); the first membrane (121, 221, 321, 421, 521) covers an end portion of the support (11, 21, 31, 41, 51); the membrane (12) further includes a third membrane (123, 223, 323, 423, 523); the third membrane (123, 223, 323, 423, 523) is arranged on an outer surface of the support (11, 21, 31, 41, 51) and is close to an end portion of the covered stent (10); and a cross section where the third membrane (123, 223, 323, 423, 523) is located includes two layers of membranes arranged on the outer surface of the support (11, 21, 31, 41, 51) and one layer of membrane arranged on an inner surface of the support (11, 21, 31, 41, 51).

Abstract: The present disclosure relates to treatment of reflux disease of a human patient. More particularly, a device is disclosed, which is configured to be implanted in the body of the human to restrict movement of the cardia of the patient's stomach towards the diaphragm opening into the patient's thorax, and/or to prevent stomach contents from passing from the stomach into the esophagus.

Abstract: A bypass tube (14) has a distal end for placement into the small intestine of a patient and a proximal end for placement near or at the pylorus. The tube comprising a pyloric anchor (16) including a gastric anchor (22) for anchoring the proximal end of the tube with respect to the pylorus to prevent distal migration. The gastric anchor comprises a tubular balloon (24) and a self-expanding structure (22a, 22b) for biasing a radially inner wall and/or a radially outer wall of the tubular balloon outwardly towards its enlarged form. The self-expanding structure comprises a first zone comprising an annular hub or collar (22a) with a first resistance to inward collapsing, and a second zone comprising a plurality of independently deflectable beams or limbs (22b) extending from the first zone, and having a smaller second resistance to inward collapsing. Also described are a pyloric anchor that twists around its axis when expanding, and a non-helical reinforcement of the flexible tube in the small intestine.

Abstract: The present invention provides methods for augmenting weight loss through metabolic surgery. More specifically, the method of the present invention includes creating a submucosal tunnel in the gastric body of a patient extending from the proximal gastric antrum to the pre-pyloric area. One or more myotomies are created in the submucosal tunnel extending from the pre-pyloric area to just distal of the opening of the submucosal tunnel. The submucosal tunnel is closed, and a running suture is performed along the greater curvature of the stomach. Optionally, an endoscopic gastroplasty may then be performed. The method of the present invention alters gastric physiology, slows gastric emptying, and augments patient weight loss.

Abstract: The present invention comprises a therapy boot for treatment of the ankle or lower leg. The therapy boot comprises a hard outer shell with an open anterior portion, a base portion, a posterior portion, and two oppositely disposed side portions extending from the base portion and connected to the posterior portion. At least one pocket with an opening may be provided in the hard outer shell. An inflatable chamber may be disposed on an inside of the at least one pocket. A respective gel pack may be adapted to be inserted into the at least one pocket through the opening to provide heat or cold to at least one of the lower leg and the ankle. Upon pressurization of the inflatable chamber, the respective gel pack is configured to be pressed against at least one of the lower leg and the ankle.

Abstract: An assistive device for preventing foot drop. The assistive device is worn around the leg and torso. An elastic cord connects the foot to a torso strap. The clastic cord wraps behind the knee to direct the tensional force in the clastic cord in the proper direction to lift the foot. A leg strap secures the clastic cord behind the knee. The torso strap may include a shoulder pad for comfort.

Abstract: Dynamic arm brace assemblies and methods of use are provided herein. An example device includes a torso connection member securable to a torso of a patient, a forearm support member that couples with at least a forearm of an patient, the forearm support member couples with the torso connection member so as to fix an elbow of the patient proximate the torso, the forearm support member being pivotally coupled to the torso connection member to allow for an angle between the forearm support member and a coronal plane of the patient, and a dynamic tensioning assembly that externally rotates the forearm support member and selectively sets the angle so as to stretch a shoulder capsule (capsule and adjacent tissue(s)) affected with adhesive capsulitis, reducing the adhesive capsulitis.

Abstract: The invention relates to a back support brace and a method of wearing the same. In a preferred embodiment, the back support brace includes a central brace portion formed to rest in support of a back of a person, a pair of adjustable brace portions configured to removably attach to the central brace portion on either side thereof, wherein each of the pair of adjustable brace portions include means to adjust the central brace portion in size according to size of the back of a person, and a removable pad or shell disposed upon the central brace portion to provide abutting support to the back of the person wearing the brace.

Abstract: Implementations of a platform device to support breasts comprise a base, a vertical pole, and a platform. In some implementations, a method of using the platform device to support breasts comprises positioning the base of the platform device to support breasts on a user's lap, on a sitting surface under a user's thighs, or on another suitable surface, further positioning the platform device to support breasts adjacent to and/or against the user's body, and resting the user's breast on the platform of the platform device to support breasts.

Abstract: An injury treatment system includes a negative pressure source and a dressing pneumatically communicable with the negative pressure source. The dressing includes a negative pressure therapy component configured to expose an anatomical structure to a negative pressure when the negative pressure therapy component is applied to the anatomical structure and in response to operation of the negative pressure source. The dressing also includes an immobilization component coupled to the negative pressure therapy system, wherein the immobilization component is configured to transition from a flexible state to an inflexible state in response to the operation of the negative pressure source.

Abstract: A sealing device for an ostomy bag is shown and described. The sealing device for an ostomy bag includes a first material having a top surface and a bottom surface, wherein the material is malleable. The first material has an adhesive along the bottom surface. The adhesive will adhere to skin. The first material can for formed into various shapes having a perimeter formed by the first material and an opening therebetween.

Abstract: A method of forming an ostomy pouch comprising: providing a film to form a first cavity wall and a second cavity wall; providing a comfort material to form a comfort layer; wherein the comfort material is a woven fabric material with a hot melt adhesive coating thereon; joining the first cavity wall to the second cavity wall at a first temperature and a first pressure for a first time period; and subsequently joining a comfort layer to at least one of the first and second cavity walls at a second temperature and a second pressure for a second time period.

Abstract: A control unit for a urinary relief system is disclosed herein. The control unit includes a pressure regulator having a high pressure inlet and a reduced pressure outlet, the high pressure inlet having a first air pressure, and the reduced pressure outlet having a second air pressure, an ejector having an pressurized air input, an vacuum port, and an air output, the pressurized air input of the ejector coupled to the reduced pressure outlet of the pressure regulator and the vacuum port connected to a storage device, an ejector head housing the pressure regulator and the ejector, and a pressurized gas source coupled to the high pressure inlet of the pressure regulator, the pressurized gas source providing an air flow having the first air pressure.

Abstract: A human interface for a urinary relief system is disclosed herein. The human interface includes a body including a top, a bottom, a front, a back, a first side, and a second side, a fluid cavity defined by the bottom, the front, the back, the first side, and the second side, the fluid cavity open through an opening in the top of the body, and an outlet extending from the fluid cavity and through the bottom, the outlet located near the back and centered between the first side and the second side.

Abstract: A storage unit for a urinary relief system is disclosed herein. The storage unit includes a body, an inlet port coupled to the body, an outlet port coupled to the body, a first porous layer disposed within the body and adjacent the inlet port, an absorbent layer disposed within the body and adjacent the first porous layer, and a second porous layer disposed within the body and adjacent the absorbent layer and the outlet port.

Abstract: A high-pressure medical cryotherapy device is provided. The device is designed for spraying liquid carbon dioxide onto a patient to alleviate inflammation through a series of treatments via a portable machine. The device features a gun-like body with a quick-connect fitting for liquid CO2 entry, a trigger-operated valve system for CO2 flow control, and a nozzle that can be attached in various ways and adjusted for different spray patterns. Additional components include a flow adjustment knob for regulating CO2 flow rate, a heating element to prevent frosting and ensure smooth CO2 expulsion, thermistors, and temperature sensors for temperature management, and lasers for visual distance referencing.

Abstract: Devices for providing thermal therapy to the perineal and rectal areas of a patient are described. The device is particularly useful for containing gushing lochia flow. Different embodiments of the device can be used to provide either hot or cold therapy to the patient. The inventive thermal pack of the current invention comprises a thermal pouch, pad and a backing layer.

Abstract: A head cooling device includes a central portion that has a predetermined volume of space and is seated on a top portion of the user's head; and a plurality of wing portions radially connected to the central portion and extending in a fan shape, wherein each of the wing portions includes a plurality of chambers each having a predetermined volume of space in which a phase change material is charged, and a plurality of bridges configured to partition and connect each of the plurality of chambers. The central portion and each of the plurality of chambers further incudes a cushioning member to protect the user's head and improve safety by absorbing and alleviating an impact applied from outside.

Abstract: A multi-layer pad for monitoring a patient includes first and second knitted fabric layers. The first knitted fabric layer includes first and second non-conductive bands and a first conductive strip that extend in a first direction. The first conductive strip is between the first and second non-conductive bands and is in contact with a power source. The second knitted fabric layer includes third and fourth non-conductive bands and a second conductive strip that extend in a second direction. The second conductive strip is between the third and fourth non-conductive bands and is in contact with the power source. A spacer is between the first and second knitted fabric layers. An impermeable cover layer encompasses the knitted fabric layers and the spacer. Upon application of force to the multi-layer pad, the first conductive strip is configured to move into close proximity with the second conductive strip and complete an electrical circuit.

Abstract: Disclosed herein is a method for treating a tumor having a temperature sensitive p53 (ts p53) mutation in a subject in need thereof. The method involves first administering to the subject a therapeutically effective amount of a chemotherapeutic drug, then inducing moderate hypothermia in the tumor for a duration sufficient to activate the mutant p53 to enhance the efficacy of the drug.

Abstract: A device for removing vitreous from an eye includes a needle defining a lumen and a port extending to the lumen. The needle is configured for insertion into the vitreous of the eye. A sample container is coupled to the needle and includes a chamber in fluid communication with the lumen. A mechanism is provided for inducing vibration in the needle to draw a sample of the vitreous into the port and to the chamber. A drug delivery system is provided for delivering a therapeutic agent through the port. At least one of the sample container and the drug delivery system extends into the vibration inducing mechanism for reducing an overall length of the device.