Abstract: A mitral valve prosthesis is percutaneously and/or transapically deployed in at least two stages. In a first stage, a mitral annular ring platform adapted for percutaneous delivery is delivered to and anchored in the mitral valve annulus. In the second stage, a valved-stent mitral valve prosthetic device adapted for percutaneously delivery is delivered to the mitral valve annulus for mounting in the mitral annular ring platform. This approach provides a consistent platform for accepting valved-stent mitral valve prosthetic devices from different vendors to be used.

Abstract: Exemplary embodiments provide methods and systems for delivering a prosthesis to a target location in a lumenal system of a patient. At least one tether is secured proximate the target location to serve as a rail, and a prosthesis is advanced along the rail to the target location and secured in place. Exemplary methods and systems provide for repair of the mitral and tricuspid valves, as well as abdominal aortic aneurysms, stomach valves, fallopian tubes and the pulmonary system, among others. Also disclosed are various prostheses suitable for use with the disclosed methods and systems.

Abstract: A multi-part medical implant device assembly for use in the surgical creation of an arteriovenous fistula is described herein, the implant device having an arterial section with an arterial lumen provided therein, a venous section with a venous lumen provided therein, and a connector section with a connecting lumen provided, the connector section serving to provide a fluid pathway from the arterial section to the venous section. The device may be formed of a top and a bottom portion, where the two-part assembly may facilitate surgical implantation.

Abstract: The ventricle of a heart can be reshaped by passing a plurality of catheters from inside the ventricle to outside the ventricle through holes in the ventricle wall. Fluid-tight bags are then delivered through the catheters and expanded outside the ventricle to a diameter that is larger than the holes. A fluid substance is introduced into the bags, and the fluid substance is configured to solidify into solid pads that are also larger than the holes. The solid pads are then pulled towards each other and locked in position in order to reshape the ventricle.

Abstract: A device for creating a fistula between blood vessels operates in conjunction with a guidewire to locate and position itself so that it straddles both vessels and is able to draw them together. A fixing agent is released either from within the device or from an external needle, or both, into the procedural site. The fixing agent functions to hold the relative position of the two vessels, to seal the surrounding tissue so that any leaks that do occur don't spread into the tissue to create a hematoma, and to limit expansion of the fistula. After the vessels are in close proximity to each other and the fixing agent is applied, the device of the invention employs a cutting mechanism which opens a portal between the two vessels.

Abstract: A bioresorbable drug-eluting biopolymer suture-free blood vessel anastomosis devices can be deployed to join two blood vessels and resorbed by the body over a predetermined time period after the blood vessel has become joined. The anastomosis device can include a hollow tube that is inserted interconnect the two vessels to be jointed. A non-piercing suture is wrapped around the vessel to secure the anastomosis. The anastomosis device can include hollow tube that extends along an axis from a first end to a second end. The ends can be fitted with elements that facilitate mechanical attachment of the vessel to the anastomosis device and provide for a secure seal.

Abstract: An occluder including at least one occluding body, a multiple of elongate members forming an expanding unit capable of expanding into at least one fixation structure for fixing the occluding body within the passage thereby expanding the occluding body), the elongate members penetrating the occluding body, a locking unit for locking the expanding unit in its expanded state, fixation bushes for restricting relative movement between the elongate members and the occluding body, each fixation bush surrounding one single elongate member and abutting the occluding body, at least one thread and wherein at least one of these fixation bushes is fastened to the at least one occluding body with this at least one thread, the thread penetrating the at least one bush and the occluding body.

Abstract: A stent having an axial end to which is attached a ring of spoons of a material different from that of the stent. In one aspect, the ring of spoons is connected to the axial end through a plurality of complementary male-female form-fitting portions. In one aspect, the ring of spoons include parallel straight side edges. In one aspect, each of the side edges lies within a first distance from a facing side edge of an adjacent spoon in a stent delivery configuration, and each of the side edges lies within a second distance, greater than the first distance, from the facing side edge of an adjacent spoon in a stent deployed configuration.

Abstract: A side-to-end vascular anastomosis device comprising a diversion conduit coupled to a lower flange which is inserted into the vessel and an upper flange located on the outside of the vessel designed to clamp together to seal the incision into which the lower flange of the device is inserted.

Abstract: An implantable medical device for connecting tissue layers, such as connecting tubular tissues to create an anastomosis, includes a single elongate member and a covering material. The devices provided may also be used for other purposes including, but not limited to, partially or fully occluding openings in tissue, temporarily or permanently holding generally planar layers of tissue together, aneurysm repair, and the like.

Abstract: Various exemplary matrix metalloproteinase (MMP) inhibiting adjuncts for surgical devices are provided. In general, an implantable adjunct can be configured to be applied to tissue by a surgical stapler in conjunction with staples. The adjunct can have at least one medicant releasably retained therein that is configured to reduce a length of the epithelialization process. In other words, the at least one medicant releasably retained in the adjunct can be configured to speed up an inflammation stage of wound healing and/or a proliferation stage of wound healing and, accordingly, reduce an amount of time before a remodeling stage of wound healing begins. The at least one medicant can be configured to be released along the staple line defined by the staples.

Abstract: A system is described for performing vascular anastomosis without the use of sutures. The system includes a connector comprised of memory material and an incision seal. The connector has one end configured to securely engage a graft vessel and another end with wings and barbs. The wings are configured to securely engage an inner wall of a main vessel and the barbs are configured to lock with the incision seal. Once locked, the incision seal and the connector apply a clamping force that secures the graft vessel with the main vessel.

Abstract: A surgical instrument includes a handpiece, an elongate shaft assembly extending distally from the handpiece, an activation assembly, an end effector disposed at a distal end of the shaft assembly, and a firing beam. The handpiece comprises a cover operable to selectively expose an interior of the handpiece. The activation assembly is selectively coupleable with the handpiece and is operable to regulate the delivery of power to the end effector. The shaft comprises a selectively removable jaw assembly. The end effector has a pivoting jaw operable to pivot toward and away from the jaw assembly to thereby capture tissue. The jaw assembly and the pivoting jaw each comprise an electrode surface. The electrode surfaces are configured to seal the captured tissue by providing RF energy to the tissue. The firing beam is configured to sever the sealed tissue.

Abstract: An anastomosis device for joining hollow lumens or viscera, suitable for deployment at the surface of two superposed adjacent lumens. The device has a main tubular body of longitudinal axis (L), having first and second open ends and opposite outside and inside faces. The main tubular body has at least three columns of loops and at least three rows of loops and sets of proximal and distal radial projections extending along at least a depth (E) at the peripheries of the first and second ends respectively. The distal and proximal sets are spaced apart by a minimum internal distance (D), and further include a set of intermediate radial projections extending along at most a depth (e) and arranged between the sets of proximal and distal radial projections. The depth (e) is less than (E), and the minimum internal distance (D) is determined so as to receive two superposed adjacent lumens.

Abstract: A prosthetic aortic valve intended for native or valve-in-valve within bioprostheses includes an expandable support scaffold and valve leaflets disposed within an upper leaflet portion of the support scaffold. The valve leaflets within the upper portion may be located within the annulus (intravalvular), above the annulus, or above the native or prosthetic leaflets (supravalvular). The valve within a previously implanted degenerated heart valve such that a base or lower portion of the replacement valve is within the previously implanted valve and the upper portion is expanded within the aorta, the internal area of the valve can be increased and the hemodynamics of the valve improved. Alternatively, the valve may include separate upper and lower portions allowing the portions to be implanted sequentially if needed and the length and other characteristics of the valve to be adjusted based on patient anatomy and condition.

Abstract: A side-to-end vascular anastomosis device comprising a diversion conduit coupled to a lower flange which is inserted into the vessel and an upper flange located on the outside of the vessel designed to clamp together to seal the incision into which the lower flange of the device is inserted.

Abstract: Implantable medical devices for connecting tissue layers or occluding body conduits and tissue structures include apposition portions, a central region, and a covering material. The methods of using the devices include endoscopic deployment, and the devices may include self-expanding frameworks that facilitate a secure connection between the tissue structures. In some embodiments, one or more tethers are used to longitudinally contract the device in situ.

Abstract: A balloon-expandable shunt is disclosed for shunting a vessel which has a graft with two ends and at least one expandable support element supporting the graft from within along a length at or near at least one of its ends. The shunt is bifurcated at an aperture that leads to a side-channel and which has a closed configuration and an open configuration such that when the aperture is in the closed configuration it defines a clot-resistant inner graft surface and when the aperture is in the open configuration it is configured to provide access to the shunt for a balloon that actuates the expandable support element. A balloon configured for actuating the shunt is also disclosed. A kit has a bifurcated graft with at least one expandable support element and a balloon for actuating the at least one expandable support element.

Abstract: A scaffold includes a radiopaque marker connected to a strut. The marker is retained within the strut by one or more of a mechanical interference fit, a polymer coating or melt, and/or by friction. The marker can take the form of a bead, rivet or snap-in marker, or a tube deformed when attached to the strut. The strut is made from a tube. The strut has a thickness of about 100 microns.

Abstract: Devices and methods for forming and securing a tissue plication are disclosed herein. In one aspect, a tissue manipulation device is described that includes a first jaw member pivotally coupled to a distal end of an elongate shaft and having an articulating portion located distal to the proximal end of the first jaw member. The device also includes a second jaw member pivotally coupled to the first jaw member such that the jaws move in a first plane, and a fastener delivery member attached to the second jaw member. The articulating portion of the first jaw member is configured to move the first and second jaw members between a straight configuration in which a longitudinal axis of the elongate shaft is contained within the first plane and an articulated configuration in which the longitudinal axis of the elongate shaft is transverse to the first plane.

Abstract: A uniportal surgical device having a slotted clear cannula, a blade and a housing, wherein the cannula is attached to the housing, and wherein the blade is enclosed in the housing and is slidable into the cannula is disclosed. The device further has a device for locking a viewing device in place relative to other components of the device. A method for a performing an operative procedure on a target tissue in a subject using the uniportal surgical device is also described.

Abstract: Disclosed is an occlusion device having an angle variable flat disk, comprising a single-layer disk (4), a plug (6) and a waist (5) connecting the single-layer disk (4) and the plug (6). The single-layer disk (4) is braided from elastic strands and comprises a plurality of radially-arranged support rods (40). Grids braided from elastic strands are provided on the surface of the plug (6). The waist (5) comprises at least one connecting strand. An annular interlocking structure is provided in the center of the single-layer disk (4). The plurality of support rods (40) are connected into a flat integral body via the annular interlocking structure. The connecting strand of the waist (5) is connected to the annular interlocking structure and the grids of the plug (6).

Abstract: This disclosure is directed primarily to a stent for use in the trachea. The stent has a nominally deployed state, an axially extended state and an axially compressed state. The stent has a length. In the axially extended state, the length is at least 20% greater than in the nominally deployed state.

Abstract: An intravascular cuff acts as a lining between a native vessel and an intravascular prosthetic device. During deployment, the ends of the cuff curl back upon themselves and are capable of trapping native tissue, such as valve leaflet tissue, between the ends. The cuff creates a seal between the vessel and the prosthetic, thereby preventing leakage around the prosthetic. The cuff also traps any embolic material dislodged from the vessel during expansion of the prosthetic.

Abstract: A percutaneous cable is attached to a mechanical cardiac pump and is passed through the skin. Sutures can be used to stabilize the cable against movement to prevent disturbing tissue surrounding cable and thereby reduce the incidence of infection. A funnel-shaped tubular device can be used where the cable exits the skin to allow the cable to flex below or near the skin surface as may be desired to accommodate physical activity of a patient. An anchor can be attached to the cable and implanted below the skin surface to stabilize the cable against movement. The anchor can include any one or a combination of a flat mesh material, a bundle of ultrafine filaments, and a barbed filament.

Abstract: Devices and methods are described herein directed to an adaptor for use with a medical device used to suture tissue within a patient's body and/or for delivering and/or securing another medical device within a patient's body. In one embodiment, an apparatus to aid in the placement of a suture at a location within a body of a patient using a medical device includes a body and a coupler configured to couple the body to the medical device. The apparatus further includes a suture mounting portion disposed on the body that defines a suture slit configured to laterally receive therethrough a portion of a suture coupled to the medical device and to apply a frictional force to the suture to resist movement of the suture longitudinally therethrough. A magnitude of the frictional force being less than a longitudinal force applied to the suture by actuation of the medical device.

Abstract: Systems and methods introduce and deploy prosthesis into a blood vessel or hollow body organ by intra-vascular access. The prosthesis is secured in place by fasteners which are implanted by an applier that is also deployed by intra-vascular access. The applier is configured to permit controlled, selective release of the fastener in a step that is independent of the step of implantation.

Abstract: In one aspect, a gastric balloon structure includes multiple isolated non-concentric inflatable chambers and a valve system for introducing fluid into each chamber, where the structure assumes, upon inflating, a curved shape conforming to a natural three-dimensional kidney shape of the gastric cavity.

Abstract: The present invention relates to a prosthesis (200) comprising:—at least one layer of a flexible mesh (1) delimited by a peripheral outer edge (1a), said mesh having a first color, and—at least one layer (2) of porous material fixed to said mesh substantially along the perimeter of said peripheral outer edge, said layer of porous material being recessed at its central part (4), said layer of porous material having a second color, different from said first color.

Abstract: A delivery device usable to deliver an inverting implant is provided that includes a positioning mechanism that automatically initiates the inversion process once a predetermined length of the implant has exited a delivery catheter. The positioning mechanism allows the implant to be safely and accurately deployed with reduced operator experience and in a greater variety of target locations.

Abstract: An embodiment of the invention includes a sewing cuff for aortic heart valves that better approximates native anatomy by better mating with the crown-like anatomical annulus. Limiting distortion of the crown-like annulus provides better blood flow and overall valve function and provides a physician greater ease of implantation since native anatomy is not flattened. Thus, the surgeon may attach sutures to the fibrous tissue of the crown-like anatomical annulus without distorting the shape of the native anatomy. An embodiment includes a scalloped sewing cuff assembly (with semilunar arches) that tracks the crown-like annulus. Another embodiment provides a sewing cuff positioned over the majority of the valve's length, thus allowing the surgeon greater flexibility as to where he or she can attach sutures to the surgical annulus. Conventional valves, which are primarily “low-profile” devices, do not offer such ability. Other embodiments are described herein.

Abstract: An endovascular stent-graft is provided that includes a flexible stent member, which includes a plurality of struts, which are shaped so as to define a generally circumferential section; a tubular fluid flow guide, which includes a graft material, and which is attached to the stent member; and at least one fixation member shaped so as to define a base at a first end thereof and a sharp tip at a second end thereof. The base is coupled to one of the struts that are shaped so as to define the generally circumferential section. When the stent-graft is in a radially-expanded deployment state, the fixation member protrudes radially outward. When the stent-graft is in a radially-compressed delivery state, at least a portion of the fixation member between the base and the sharp tip is convex as viewed from outside the stent-graft, such that the sharp tip points radially inward.

Abstract: An electrosurgical instrument for making an end-to-end anastomosis between two hollow organ sections includes two tools movable relative to each other and each including an HF electrode by which the hollow organ sections can be fusion-welded to each other. The two tools are substantially sleeve-shaped or can at least be brought into sleeve shape so that a first tool can enclose a first hollow organ section and a second tool can enclose a second hollow organ section. Each of the electrodes is formed on an end face of each sleeve-shaped tool around which the respective hollow organ section can be everted inside out, and the two tools are movable relative to each other so that the electrodes are aligned and can clamp the everted hollow organ sections therebetween.

Abstract: The invention is an implantable magnetic anastomosis device having an exoskeleton that directs self-assembly. The design allows the device to be delivered in a linear configuration using a minimally-invasive technique, such as endoscopy or laparoscopy, whereupon the device self-assembles into, e.g., a polygon. A coupled set of polygons define a circumscribed tissue that can be perforated, or the tissue can be allowed to naturally necrose and perforate. The device can be used to create anastomoses in a variety of tissues, such as tissues found in the gastrointestinal, renal/urinary, and reproductive tracts. New procedures for using anastomoses, e.g., surgical bypass are also disclosed.

Abstract: A device for anastomosis of a tubular structure comprises first and second hollow members having a rigid part and an elastic part, and a connection member for interlocking the first and second members. The elastic parts are essentially circular rings, and are made of a polymeric, a biocompatible and/or biodegradable material. The rigid parts have an outer surface that is partly semi-circular in cross section, wherein the diameter at a non-connecting end is larger than or equal to the diameter at a connecting end, which ends in an edge. The first and second members are connected to each other so that a distance is formed between the elastic parts. A cavity is formed between the rigid parts and the connection member and the tubular structure, when arranged in the device.

Abstract: A shunt rivet for implantation in the aorta and inferior vena cava to treat chronic obstructive pulmonary disease, and a method of treating chronic obstructive pulmonary disease.

Abstract: Systems and methods for aligning hair follicle are provided. The systems may include at least one piercing member. The piercing member may be configured to pivot about a pivot axis. The piercing member may be operable to translate along a chosen axis, wherein the chosen axis may intersect with the pivot axis. The translation of the piercing member in a first direction may enable the piercing member to pierce through an external surface of a skin, and translation of the piercing member in a second direction may enable the piercing member to retract out of the skin.

Abstract: A surgical tissue connector system for moving a first internal body tissue to a position away from a second internal body tissue and then holding the first internal body tissue in the position. Tissue connectors are secured to cords such that the length of cord between the tissue connectors can be easily adjusted in a laparoscopic work space.

Abstract: An anastomosis device for facilitating sutureless side-to-side arteriovenous fistula creation and maintenance of patency thereof is presented. The device comprises two device halves each containing an anastomosis window which is in fluid connection with an interior lumen of the device. Further, the device comprises a pair of vessel joining portions in which the bounds of the fistula are created. The invention also has an embodiment wherein a method of joining a vein and an artery in order to create a fistula is presented.

Abstract: This tissue fastening apparatus is a tissue fastener for clamping first biological tissue and second biological tissue so as to be in close contact with each other, including: a first tissue fixation portion, made of an elastic wire wound in a coil, that is locked on the first biological tissue; and a second tissue fixation portion, made of an elastic wire wound in a coil, that is locked on the second biological tissue, the second tissue fixation portion continuing into the first tissue fixation portion, in which when falling off first and second biological tissue necrotized by being clamped between the first tissue fixation portion and the second tissue fixation portion, the tissue fastener moves only from the second tissue fixation portion to the first tissue fixation portion side and falls off.

Abstract: An external electronic ear device includes a housing, an external magnet, a microphone, a processing circuit and a wireless signal transmitter circuit. The external magnet is disposed in the housing and attracts a receiver magnet disposed under a scalp of a user. The microphone is disposed in the housing and receives an external sound and generates a sound signal corresponding to the external sound. The processing circuit is disposed in the housing and converts the sound signal into an electrode driving signal. The wireless signal transmitter circuit is disposed in the housing and transmits the electrode driving signal to a cochlear implant device in the cochlear system. The cochlear implant device converts the electrode driving signal into a plurality of electrode currents, and a plurality of electrical pulses are generated in a cochlear nerve of the user through a plurality of electrodes according to the electrode currents.

Abstract: A sled for use with an anvil assembly delivery system is provided which includes a body defining a concavity dimensioned to receive an anvil head of an anvil assembly and a recess dimensioned to receive a center rod of the anvil assembly. The body has a smooth outer profile to facilitate atraumatic trans-oral insertion of the anvil assembly to a surgical site. The body further defines a first suture channel on each side of the recess to facilitate securement of the body to the anvil assembly.

Abstract: Methods, devices, apparatus, assemblies, and kits for performing a vascular anastomosis are disclosed. A device for a vascular anastomosis includes tissue engaging portions that can move between at least two configurations. In some embodiments, the tissue engaging portions move without the aid of moving parts, while in other embodiments the tissue engaging portions extend from one or more movable wings. The tissue engaging portions may be separated by a first distance when in a pre-deployment configuration and by a second distance when in a deployed configuration. A method includes engaging a plurality of tissue engaging members of a coupling device against first end tissue. After selectively engaging the tissue engaging members and first end tissue, the first end tissue is stretched by at least moving the tissue engaging members. The stretched first end tissue is coupled to the second end tissue by mating the coupling device to a mating anastomosis device.

Abstract: A cannula includes a first circumferential portion, a second circumferential portion, and a seal with a first clamping surface. The first circumferential portion and the second circumferential portion are configured to mutually cooperate to support a circumference of vasculature, and form a second clamping surface. The first clamping surface and the second clamping surface are configured to cooperate to secure an end of the vasculature.

Abstract: A gastrointestinal implant device (2800) comprises a planar proximal element (220) configured to reside in a stomach to resist distal migration, a distal element (222) configured to reside in an intestine to resist proximal migration and one or more tethers (224) coupling the planar proximal element to the distal element.

Abstract: A gastrointestinal implant device comprises a planar proximal element configured to reside in a stomach to resist distal migration, a distal element configured to reside in an intestine to resist proximal migration and one or more tethers coupling the planar proximal element to the distal element.

Abstract: A cuff is used to provide a form for curing fluid about the exterior of an end-to-end anastomosis site. The cuff includes a port through which fluid may be injected to reach an interior space defined between the exterior of tissue at the anastomosis site and the inner surface of the cuff. A circular stapler may be used as a mandrel for the cuff and fluid. Alternatively, inflatable balloons may be used as a mandrel. The curing fluid may comprise a mixture of fibrin and thrombin.

Abstract: An anastomotic connector comprises a generally tubular access port having a first end and a second end, a generally tubular main body portion having a first end and a second end, wherein the second end of the main body portion is positioned adjacent to the second end of the access port such that the main body portion and access port are in fluid communication, and an anchor member received, within the access port and having a plurality of fingers that are extendable from the first end thereof. The fingers of the anchor member are movable between a loaded position wherein the fingers are substantially parallel to a center axis of the access port and an expanded position wherein the fingers are substantially perpendicular to the center axis of the access port.

Abstract: A connector for joining a first hollow structure to the side wall of a second hollow structure, the connector comprising a first component comprising an inner collar; a hollow body; and a graft mounted to the inner collar and forming a conduit through the hollow body and the inner collar; and a second component comprising an outer collar and a hollow body, the hollow body of the second component being sized for coaxial disposition over the hollow body of the first component so that the outer collar of the second component can be adjustably positioned relative to the inner collar of the first component and so that the conduit of the graft provides fluid communication between (i) the region beyond the inner collar, and (ii) the region beyond the hollow body of the first component.

Abstract: An extravascular anastomosis device for facilitating side-to-side arteriovenous fistula creation and maintenance of patency thereof is presented. The device comprises two device halves each containing an anastomosis window which is in fluid connection with an interior space of the device. Further, the device comprises a pair of vessel capture spaces in which portions of the vessels to be joined are captured. The invention also has an embodiment wherein a method of joining a vein and an artery in order to create a fistula is presented.