Abstract: A prosthetic heart valve for replacing a native valve includes a stent having a plurality of struts, an inflow end, an outflow end, a collapsed condition and an expanded condition. A valve assembly is disposed within the stent. A first cuff is annularly disposed adjacent the stent, and a second cuff is annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The second cuff is at least partly radiopaque and may assist in determining the relative position between the second cuff and a patient's anatomy using fluoroscopy during an implantation procedure.

Abstract: A device for delivering an implant to a surgical location of a patient is provided. In some embodiments, an example device includes a polymer body having first and second tapered sections and a sealed cavity defined by the polymer body. The polymer body is separable between the first and second tapered sections.

Abstract: This document describes methods and devices for securing epicardial devices. For example, this document describes methods and devices for securing epicardial devices by passing a sheath into a pericardial space of a patient through a first percutaneous access site, passing a guidewire through the sheath into the pericardial space of the patient, passing the guidewire through a transverse sinus of the patient, passing a snare device into the pericardial space through a second percutaneous access site, and capturing a free end portion of the guidewire using the snare device.

Abstract: Devices and methods for body conduit lengthening and anastomosis creation can be used to treat patients with a variety of health conditions. For example, among other uses, this document describes esophageal lengthening and anastomosis devices that can be used to remedy esophageal atresia in neonatal patients.

Abstract: A localization tool for localizing and marking a nodule of a patient includes a magnetic portion for locating a magnetic fiducial marker disposed in or adjacent the nodule, and an electrocautery element for marking the nodule or tissue adjacent the nodule upon locating the magnetic fiducial marker.

Abstract: Methods and devices for catheter-based removal of unwanted tissue or occlusive matter from blood vessels and other body lumens rely on a wire advanced from a tube to deploy a capture net that can be drawn over the clot. Apparatus include simple and reliable mechanisms for deployment of nets, funnels, and other clot capturing mechanisms for retrieving clot material from inside a blood vessel.

Abstract: The disclosure relates to a medical engineering robot, a medical system, a method for operation thereof, a corresponding computer program, and a corresponding computer-readable storage medium. By controlling a pose of an instrument arm of the robot relative to a respective examination object to be treated or to be examined by the robot, the disclosure makes provision for automatically bringing the instrument arm into contact with the examination object and through this for setting a predetermined pose of the examination object.

Abstract: Kit includes coaptation aid and fixation system for repair of leaflets of a heart valve. Coaptation aid includes coaptation catheter having an expandable member at a distal end thereof adapted to be introduced to a left ventricular outflow tract of a heart via a retrograde approach. Expandable member has a delivery configuration with a reduced cross-dimension and a deployed configuration with an expanded cross-dimension adapted to contact a ventricular side of a first leaflet of a heart valve and position the first leaflet generally proximate a coapting configuration with a second leaflet. Fixation system includes a delivery catheter having a distal end, and a fixation device removably coupled to the distal end of the delivery catheter and is adapted to couple the first leaflet to the second leaflet of the heart valve. Methods for fixation of native leaflets of a heart valve using a coaptation aid also disclosed.

Abstract: Ring comprising: an outer belt (3) equipped with closing means (7) for closing the ring (1) around a duct (2); an inner chamber (4) that can be inflated and deflated; a flexible inflation/deflation tube (5); wherein the lips have contact surfaces facing each other, the closing means comprising at least one perforation arranged on the contact surface of a first of the two lips and at least one protrusion protruding from the contact surface of a second of the two lips, the protrusion and the perforation being configured so that the protrusion is retained in the perforation by fitting, the fitting being selected to be released in the event of overpressure in the ring.

Abstract: An improved gastroesophageal reflux preventer and related methods are provided. The improved gastroesophageal reflux preventer may include an absorbable material able to be placed in contact with a body organ and configured to induce a scarification of the body organ in response to absorption by the body organ of the material. In this manner, a proximate sphincter may be tightened, such as to ameliorate reflux through a gastroesophageal sphincter.

Abstract: A calibration system for calibrating a pressure output of a fluid injector having a housing configured for connecting to the fluid injector; a drive member engagement portion configured for contacting a drive member of the fluid injector; a compressible member, which may have a known modulus of compression, connected at its proximal end to the drive member engagement portion, wherein the compressible member is compressed with movement of the drive member of the fluid injector between a first, uncompressed position and a second, at least partially compressed position of the fluid injector in a distal direction; and a sensor connected to the compressible member is described. The sensor is configured for measuring at least one of a force imparted by the drive member and a displacement of the drive member when the compressible member is in the second, at least partially compressed position.

Abstract: A method of treating prolapse of a vagina includes supporting the vagina by implanting a sacrocolpopexy support and locating an exterior surface of the vagina between leg portions of a vaginal cuff section of the support, and securing a head section of the support to a ligament or a sacrum while isolating the head section from contact with tissue of the vagina.

Abstract: The present disclosure relates generally to the field of medical devices and establishing fluid communication between body lumens. In particular, the present disclosure relates to devices and methods for placing the muscularis layers of first and second body lumens in contact to establish a long term or permanent open flow or access passage therebetween.

Abstract: A cellular support system comprises a three-dimensional scaffold structure comprising at least one void. At least one suspended protein bridge spans across the at least one void in the three-dimensional scaffold structure. The suspended protein bridge is capable of supporting cells and promotes three-dimensional cellular growth. In certain aspects, the protein in the suspended protein bridge is an extracellular matrix protein, such as collagens, laminins, fibronectins, and combinations thereof. Such a cellular support system supports thriving cell cultures in three-dimensions emulating cell growth in vivo in an extracellular matrix, including promoting cell remodeling. Methods for making such cellular support systems are also provided.

Abstract: A mesh deployment device having separate mesh deployment and actuation units is provided. A mesh deployment device includes an actuation unit and a mesh deployment unit configured to be releasably secured to the actuation unit. When the mesh deployment unit is secured to the actuation unit, a first actuation of the actuation unit moves the mesh deployment unit from an expanded condition to a collapsed condition and a second actuation of the actuation unit moves the mesh deployment unit from the collapsed condition to the expanded condition. The mesh deployment device may further include a mesh releasably secured to the mesh deployment unit. A third actuation of the actuation unit may release the mesh from the mesh deployment unit. Also provided is a kit including multiple mesh deployment units.

Abstract: Described are devices, implants, kits, and related methods for treating pelvic conditions such as urinary in incontinence, in a male or a female patient. The invention includes, in one embodiment, a multi-piece implant, including a tissue support piece, extension portion, and one or more self-fixating tips. The device may be employed through a medial incision in the pelvic region of the patient.

Abstract: A heart valve prosthesis is provided that includes a first member and a second member. The first member comprises a first central portion to be disposed adjacent to a line of coaptation on a first side of two adjacent heart leaflets and peripheral portions to be placed into direct contact with the two adjacent heart leaflets. The second member is separate from or can be separable from the first member, for example during delivery. The second member has a central portion and peripheral portions configured to be placed into direct contact with a second side of the two adjacent heart leaflets.

Abstract: An implantable prosthesis for repairing a defect in a muscle or tissue wall. The prosthesis comprises a body of biologically compatible prosthetic material having a preformed three-dimensional contoured shape that independently assumes a three-dimensional curved shape configured to conform to the muscle or tissue wall. The body may be formed of a mesh fabric employing a knit construction. The body may be configured with one or more mechanical characteristics, individually or in any combination, having defined properties which may enhance the ability of the prosthesis to be handled in a surgical, robotic environment while meeting the performance and physical characteristics for soft tissue repair and reconstruction. One or more visual indicia may be provided to facilitate positioning and/or placement of the prosthesis at the muscle or tissue wall.

Abstract: A system and method for performing surgical procedures within a body cavity, e.g. abdomen, uses a magnetized device is utilized to allow a surgeon to control intra-abdominal organs and objects. The system and method allows a surgeon to perform an intra-abdominal procedure without the need to position surgical tools inside of the body cavity. Additional surgical ports are not necessary as the magnetized device allows the surgeon to retract or position various objects within the abdomen.

Abstract: A medical device includes an elongate member configured to be at least partially disposed within a body of a patient. The elongate member has an outer surface. The outer surface of the elongate member has a first ridge and a second ridge.

Abstract: Devices and methods for providing localized pressure to a region of a patient's heart to improve heart functioning, including: (a) a jacket made of a flexible biocompatible material, the jacket having an open top end that is received around the heart and a bottom portion that is received around the apex of the heart; and (b) at least one inflatable bladder disposed on an interior surface of the jacket, the inflatable bladder having an inelastic outer surface positioned adjacent to the jacket and an elastic inner surface such that inflation of the bladder causes the bladder to deform substantially inwardly to exert localized pressure against a region of the heart.

Abstract: Devices, systems and methods for altering functioning of a tissue/organ by application of force thereto. In one preferred embodiment, a device for reducing or preventing regurgitation of blood through a valve of a heart is provided. A device may include a main body having a segment adapted to apply force to a surface of tissue/organ; a member that applies counterforce to the force applied by the segment; and an adjuster that is manually operable to change the force applied by the segment. The adjuster can be manually operated before or after anchoring of the device to the tissue/organ.

Abstract: A device for delivering an implant to a surgical location of a patient is provided. In some embodiments, an example device includes a polymer body having first and second tapered sections and a sealed cavity defined by the polymer body. The polymer body is separable between the first and second tapered sections.

Abstract: A device for delivering an implant to a surgical location of a patient is provided. In some embodiments, an example device includes a polymer body having first and second tapered sections and a sealed cavity defined by the polymer body. The polymer body is separable between the first and second tapered sections.

Abstract: Reinforcing sleeves for medical device lumens are disclosed. In some embodiments reinforcing sleeves may provide resistance to crushing, kinking, or other deformation of the lumen. Reinforcing sleeves within the scope of this disclosure may be displaceable along an outer diameter of a reinforced lumen. Some reinforcing sleeves within the scope of this disclosure comprise metal alloys.

Abstract: An arteriovenous graft system is described. The arteriovenous graft system includes an arteriovenous graft that is suited for use during hemodialysis. In order to minimize or prevent arterial steal, at least one valve device is positioned at the arterial end of the arteriovenous graft. In one embodiment, for instance, the arteriovenous graft systems includes a first valve device positioned at the arterial end and a second valve device positioned at the venous end. In one embodiment, the valve devices may include an inflatable balloon that, when inflated, constricts and closes off the arteriovenous graft. If desired, a single actuator can be used to open and close both valve devices.

Abstract: A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Abstract: Systems and methods are provided and adapted to engage and pull (e.g., pull up) or reposition paraurethral support tissue, such as the perineal membrane. The perineal membrane intersects the urethra and vagina at the midurethra or distal location and can thus be stabilized or controlled in a manner that helps restore continence. As such, the implants can be utilized to eliminate the need for mesh or other supportive structures under the urethra that is common with other incontinence slings.

Abstract: Pelvic implant having a frame with two arms and a sheet are disclosed. The sheet may be held under tension in the assembled implant. The implant may be planar (flat) or may be non-planar. The implant may be contoured laterally. A curved non-planar implant may be convex or concave in a rostro-caudal direction. The implants may (optionally) include two additional arms and a second sheet for supporting a urethra and/or a bladder neck. Methods for constructing and assembling the implants are disclosed. A method ultrasonically welding the frame of the implant without thermally damaging the sheet is disclosed. Methods of implantation of the implants are disclosed.

Abstract: The embodiments relate to cardiac assist devices that comprise a jacket that wraps the exterior of the heart, where the jacket comprises one or more pneumatic or hydraulic bladders. The pneumatic or hydraulic bladders are linked to a pump, and the pump fills the bladders with fluid and withdraws the fluid in a cycle to match beats of the heart to assist contraction and pumping of the heart in systole or to assist expansion and filling of the heart in diastole.

Abstract: In one aspect, wireless gastrointestinal stimulations are described herein. In some embodiments, a system described herein comprises at least one transmitter and at least one stimulation device. The transmitter can include a signal generator operable to generate an electromagnetic signal, a first antenna operable to broadcast the electromagnetic signal, and an energy source. The at least one stimulation device is operable to deliver a pattern of electrical pulses to a gastrointestinal tissue comprising a muscle, and the stimulation device includes a circuit board having a circumference, at least one second antenna wrapped around the circumference of the circuit board, the at least one second antenna being configured to receive the electromagnetic signal and to generate an electrical current from the electromagnetic signal, and at least one electrode operable to deliver the electrical current to the muscle.

Abstract: The invention provides improved devices, systems, and methods for tissue approximation and repair at treatment sites. The invention provides devices, systems, and methods that may more successfully approximate and repair tissue by improving the capture of tissue into the devices. The invention may be a one-way mechanism that allows tissue to enter the mechanism but not easily exit, such as a leaf-spring, a protrusion, a pivoting arm and one or more frictional elements.

Abstract: Circulatory assistance device for a heart of a living being, including a cuff for periodically applying pressure to the heart by at least one dielectric elastomer membrane which is controllable by a control device in synchronization with a cardiac beat in order to convey blood in pulses, wherein the cuff is designed to be pulled over the outside of the heart and for this purpose has an inner shape that is adapted to the outer contour of the heart at least in the region outside the ventricles, wherein the cuff is composed of an outer contraction layer including the dielectric elastomer membrane and an inner padding layer, and the inner padding layer is filled with an incompressible liquid and has at least one outlet valve, which is closed in a normal state and opened in an emergency state.

Abstract: An implantable prosthetic device such as might be used to treat poor function of a diseased heart valve in a medical patient includes a body portion and an anchor portion including a plurality of paddles. Clasps attached to the paddles include fixed arms and moveable arms operable to secure the device to the patient's native valve leaflets.

Abstract: Surgical systems and methods for administering an ablation treatment and other therapeutic or diagnostic protocols to a patient tissue involve a flexible stabilizer mechanism having an inner recess and an ablation mechanism coupled with the stabilizer mechanism.

Abstract: An implantable sensor is proposed including a ring shaped element and a coil. The ring shaped element is made of a silicone and is electrically conductive. The coil may be formed by a wire with a number of windings, wherein at least the free ends of the wire are enclosed by the silicone of the ring shaped element, wherein an electrical resistance of the ring shaped element varies upon a deformation of the ring shaped element.

Abstract: In one embodiment, an apparatus includes a support portion disposable within a pelvic region and a strap extending from the support portion. The strap has a length and is configured to be disposed at least partially within a pelvic tissue. A sleeve is releasably disposed over at least a portion of the strap. The sleeve has a length that is longer than the length of the strap. In some embodiments, the length of the sleeve is at least twice as long as the length of the strap. In some embodiments, a suture couples the sleeve to the strap. The apparatus can also include a suture disposed at least partially within an interior of the sleeve and forming two strands of suture within the interior of the sleeve. The two strands are separated by a distance defined by a separator portion of the sleeve.

Abstract: A heart implant alignment and delivery device includes an elongate body having an opening that is disposed near a distal end of the elongate body. The opening is configured so that a heart implant is positionable within the opening with the heart implant exposed to a surrounding environment and so that the heart implant is substantially aligned with the distal end of the elongate body. The device also includes an implant reposition member, such as a cable, that is releasably coupleable with the heart implant and that is operationally coupled with the elongate body so that a first operation of the implant reposition member causes the heart implant to be retractably deployed from the opening of the elongate body. The first operation of the implant reposition member may be effected via a handle mechanism that is attached to a proximal end of the elongate body.

Abstract: Device sand methods for improving cardiac function are provided. The device includes a dome structure having a top end with an engagement element disposed thereon. The dome structure is moveable from a first inside out configuration to a second deployed configuration, and the dome structure is biased in the second deployed configuration. The dome structure includes a plurality of anchor members disposed around a bottom open end of the dome structure.

Abstract: An intra-abdominal liver retraction device and methods of use. The device includes a flexible sling, an anchor and a filament. The sling has a base edge and a pair of side edges tapering toward a leading edge. The sling also includes a stiffener extending across it adjacent the base edge to enable it to be gathered and inserted through a port into the abdomen, whereupon it can be opened. The anchor is configured to be releasably secured to the diaphragm with the base edge adjacent the diaphragm so that the liver can be disposed on the sling. The filament is connected to the sling adjacent the leading edge and configured to be drawn through an aperture in the abdominal wall to lift the sling with the liver thereon upwards.

Abstract: An exemplary implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The coaption element can have a structure that is impervious to blood and that allows the native leaflets to close around the coaption element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The coaption element can be connected to leaflets of the native valve by the anchor.

Abstract: A cervical retraction system includes a suture having a first end and a second end, a cervical anchor secured to the first end of the suture and a curved needle secured to the second end of the suture. A method of retracting a cervix includes providing the cervical retraction system, inserting the curved needle through tissue of a cervix of a patient, advancing the needle along a trajectory of a curve of the needle until it emerges through an external os of the cervix and applying counter tension by pulling the needle out through the external os.

Abstract: Embodiments of elongate pelvic implants and methods for treating pelvic conditions, such as incontinence, are provided. The implants can include a tissue support portion, one or more extension portions and one or more anchors. The implant is constructed as a unitary sling implant. The implant can be constructed or formed in a generally elongate shape to provide a lattice support structure of repeated cells.

Abstract: The invention provides improved devices, systems, and methods for tissue approximation and repair at treatment sites. The invention provides devices, systems, and methods that may more successfully approximate and repair tissue by improving the capture of tissue into the devices. The invention may be a one-way mechanism that allows tissue to enter the mechanism but not easily exit, such as a leaf-spring, a protrusion, a pivoting arm and one or more frictional elements.

Abstract: Devices and methods for providing localized pressure to a region of a patient's heart to improve heart functioning, including: (a) a jacket made of a flexible biocompatible material, the jacket having an open top end that is received around the heart and a bottom portion that is received around the apex of the heart; and (b) at least one inflatable bladder disposed on an interior surface of the jacket, the inflatable bladder having an inelastic outer surface positioned adjacent to the jacket and an elastic inner surface such that inflation of the bladder causes the bladder to deform substantially inwardly to exert localized pressure against a region of the heart.

Abstract: An embodiment includes an artificial chordae tendineae system comprising: a first needle; a flexible first chord coupled to a proximal end portion of the first needle; a first proximal pledget coupled to a proximal end portion of the first chord; a first distal conduit coupled to the first chord between the first proximal pledget and the first needle; wherein: the first distal conduit includes first and second faces; one of the first and second faces includes a first aperture; a sidewall of the first conduit, located between the first and second faces, includes a sidewall aperture that does not directly connect to the first aperture; the sidewall aperture is configured to include a portion of the first chord when the first distal conduit is permanently implanted adjacent tissue but not when the first distal conduit is traversing the tissue before being permanently implanted adjacent the tissue.

Abstract: The present embodiments herein relate to an improved needle design and control methodology for fractured directed guiding to a desired target. This system has the capability to control the insertion not only in 2D-plane, but also in 3D-space in a very controlled manner. A method of controlling the path of movement of a needle structure toward a target can include a stylet type of needle configuration or a water-jet needle configuration.

Abstract: A system and method for installing/implanting a leadless implant can include a leadless implant with shortened tine-based anchors and an implantation tool with a modified tip. The tines can extend from a surface of the leadless implant and may include a preformed curve or other shape to enable the tine to hook into or grapple tissue. The implantation tool may be provided with a modified tip to assist with proper alignment, insertion, and anchoring of the shortened tines. A tip of the implantation tool can have a reduced inner diameter to cause the tine tips to be approximately normal to the surface of the tissue to which the implant is being anchored. Upon deployment of the leadless implant, the tines of the anchoring mechanism are appropriately aligned for proper insertion so that robust anchoring is achieved.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element having four layers; and a pair of paddles connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: In one embodiment, an apparatus includes a support member and a suture. The support member is configured to provide support to a portion of a body of a patient. The support member has a first end portion and a second end portion. The first end portion of the support member is configured to be disposed within a body of a patient. The suture is removably coupled to the first end portion of the support member and is configured to extend through an incision in the body of the patient from a location within the body of the patient to a location outside of the body of the patient.