Abstract: Described here are systems and methods for accessing Schlemm's canal and for delivering an ocular device, tool, or fluid composition therein. The ocular devices may maintain the patency of Schlemm's canal without substantially interfering with transmural fluid flow across the canal. The fluid composition may be a viscoelastic fluid that is delivered into the canal to facilitate drainage of aqueous humor by disrupting the canal and surrounding trabeculocanalicular tissues. Some systems described here may be configured to cut or tear the trabecular meshwork with the body of an elongate member located within Schlemm's canal. Other tools for disrupting these tissues and minimally invasive methods for treating medical conditions associated with elevated intraocular pressure, including glaucoma, are also described.

Abstract: An implantable prosthetic valve assembly, according to one embodiment, comprises a frame assembly including a plurality of struts and a prosthetic valve secured inside the frame assembly by sutures. The sutures are inward of the outermost surface of an outer periphery of the frame assembly. In certain embodiments the struts contain recesses in which sutures can be disposed. In other embodiments, the struts can have holes through them which the sutures pass through. The implantable prosthetic valve assembly can also be collapsed within a catheter such that an outermost surface of a periphery of the frame assembly touches the catheter but the sutures are spaced apart from the catheter or are flush with the outer surface of the frame.

Abstract: Medical devices for closing anatomical apertures, such as atrial or ventricular septal defects, are disclosed. The medical devices can include a plug body having a proximal end, a distal end, and a longitudinal axis. The plug body can include an exterior surface, an interior surface defining an interior lumen, and a seal which can be located within the interior lumen. The medical devices can also include at least one arm member extending through the plug body between the exterior surface and the interior surface of the plug body. In certain embodiments, the medical device can include a distal loop and a proximal loop extending through the plug body. In certain embodiments, the proximal loop can be smaller than the distal loop, such that a top end and a bottom end of the proximal loop can fit within a top end and a bottom end of the distal loop.

Abstract: A plug for occluding an ocular canaliculus comprises a cylindrical body member having a first outer diameter. The cylindrical body member is provided along an external surface with at least one outwardly extending projection having a second outer diameter greater than the first outer diameter and larger than an inner diameter of an ocular canaliculus. The first outer diameter of the plug is typically less than and approximately equal to the inner diameter of the canaliculus.

Abstract: An implantable ocular drug delivery system can include inserting an implantable device into an eye, where the device contains therapeutics intended to be released for local or systemic effects. In some implantable device embodiments, the device includes a microchannel intended to reduce intraocular pressure. In some implantable device embodiments, the device includes a microchannel intended to treat dry eye.

Abstract: Disclosed herein is an apparatus. The apparatus includes a solid wire and a delivery catheter. The solid wire being provided with one or more retention mechanisms at a proximal end, a distal end, or both. The delivery catheter being capable of maintaining the one or more retention mechanisms in a delivery configuration. The one or more retention mechanisms are configured to expand to a deployed configuration upon removal of the delivery catheter.

Abstract: An ocular implant adapted to be disposed within Schlemm's canal of a human eye with a body extending along a curved longitudinal central axis in a curvature plane, a first strut on one side of the implant and a second strut on an opposite side of the implant, the circumferential extent of the first strut with respect to the plane of curvature being greater than the circumferential extent of the second strut with respect to the plane of curvature. The invention also includes methods of using the implant.

Abstract: The present invention provides gastrointestinal devices for limiting transfer and contact of material across luminal walls along a segment of the gastrointestinal tract (e.g., at the duodenum and/or upper jejunum). Devices of the invention include a gastrointestinal sleeve, an anchor, and a flange for attachment to a luminal wall proximal to the pyloric orifice. The invention also provides methods of use associated with such gastrointestinal devices, including methods for delivery, removal, and treatment of metabolic disorders, such as type 2 diabetes, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, obesity, and related comorbidities thereof by implanting gastrointestinal devices.

Abstract: Connectors interfacing a mechanical circulatory system with a patient's natural vasculature are provided herein. Such connectors include aortic connectors that facilitate fluid coupling of an outflow graft tube from an implanted blood pump with a patient's aorta. Aortic connectors can include a substantially planar portion configured for sealed attachment with a wall of the aorta and a tubular connector portion extending from an inlet opening to an outlet opening. The substantially planar portion can include a flexible membrane for attachment to an outer surface of the aorta and/or a flange for engagement with an inner surface of the aorta. The tubular connector can extend from the substantially planar portion at a pre-determined angle and include one or more attachment features to facilitate rapid fluidly sealed attachment to the outflow graft tube.

Abstract: A patient may be treated by implanting a combined arterial venous fistula graft implant in a limb of the patient. The combined implant includes a body with a vessel segment in contact with an artery and a first tubular segment for attachment to an end of a vein to form an arterial venous fistula, and a second tubular segment with an attached segment of artificial tubing for attachment to the vein at a second location to form an arterial venous graft. The arterial venous graft may be exclusively used to form hemodialysis for a period of time after the implanting step, while the arterial venous fistula matures.

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: Intraocular drainage devices, intraocular implantation procedures, and inserter devices for intraocular implantation procedures are disclosure. A disclosed intraocular drainage device includes a tube having a distal end and a body disposed proximal to the tube. An inlet port is disposed on the distal end of the tube and configured to receive an influent fluid from an anterior chamber of an eye. An inlet fluid pathway is coupled to the inlet port and extends at least partially through the tube. A plurality of outlet fluid pathways extend at least partially through the body and branch from the inlet fluid pathway. A plurality of outlet ports are disposed on the body and coupled to the plurality of outlet fluid pathways. A disclosed inserter device for an ocular implantation procedure includes a handle, a needle, and a plunger. The needle is disposed on a distal end of the handle and configured to hold an intraocular drainage device. The plunger is coupled to the needle and disposed in the handle.

Abstract: Methods are provided for using an intraocular shunt deployment device to deploy an intraocular shunt from the device and into an eye.

Abstract: Methods for performing certain medical procedures wherein a steerable endoluminal punch is used to not only gain access but to create a channel or punch through tissue, thus facilitating follow-up therapeutic procedures. The distal end of the steerable endoluminal punch is controllably articulated by the operator using a control device at the proximal end.

Abstract: Some embodiments are directed to magnetic puncture access and delivery systems and methods, including creating a passageway, such as a fistula, between two vessels or segments of a vessel. A system can include two catheters, each carrying a plurality of magnets along a longitudinal axis of each catheter.

Abstract: Medical devices and related method for improving blood flow to regions of a patient are described herein. Some medical devices may include a first graft portion, a second graft portion, and a catheter portion disposed between the first graft portion and the second graft portion. The medical device may be implanted into a patient to establish a non-natural flow path.

Abstract: Extra-urethral implants and methods of use are disclosed. Implants can treat disorders or diseases of the prostate by, for example, enlarging the lumen of the prostatic urethra.

Abstract: Articulation devices, systems, methods for articulation, and methods for fabricating articulation structures make use of balloon arrays, with inflation of the balloons locally altering articulation. Inflation fluid may be directed toward the balloons from an inflation fluid source via a series of channels, the balloons and channels included in a helical multi-balloon assembly. The balloons may be supported by encasing the helical balloon assembly in a polymer matrix, such as by winding the balloon assembly onto a mandrel and dip-coating some or all of the assembly in an elastomer such as a silicone, a urethane, or the like. The balloons may be supported by one or more spring, with loops of the spring(s) optionally being inward of the balloons, outward of the balloons, or interspersed between the balloons, and/or a mesh tube, braid, or other compliant materials may be included.

Abstract: The invention relates to a permanent interpositional ophthalmological implant between the sclera and the uveal tis-sue. The implant comprises a thin uvea-compatible body (50) having a thickness (e) which is at least less than IO times the smallest of the two other dimensions of the body, the body of the implant comprising two opposing edges separated from one another along one of the two dimensions perpendicular to the thickness, and one of the edges, known as the front edge (52), being curved in a concave manner away from body in a plane perpendicular to the thickness.

Abstract: Devices are provided with an internal dimension that can be reduced and increased in vivo. In one example, an interatrial shunt for placement at an atrial septum of a patient's heart includes a body. The body includes first and second regions coupled in fluid communication by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between a first atrium and a second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. A flow area of the passageway through the neck region may be adjusted in vivo.

Abstract: Described here are systems and methods for accessing Schlemm's canal and for delivering an ocular device or fluid composition therein. The ocular devices may maintain the patency of Schlemm's canal without substantially interfering with transmural fluid flow across the canal. The fluid composition may be a viscoelastic fluid that is delivered into the canal to facilitate drainage of aqueous humor by disrupting the canal and surrounding trabeculocanalicular tissues. Tools for disrupting these tissues and minimally invasive methods for treating medical conditions associated with elevated intraocular pressure, including glaucoma, are also described.

Abstract: Disclosed herein are implantable dual-valve devices having first and second valve structures, a connector coupled to the structures, and first and second sealing members coupled on each side of the device, along with related methods of deploying such devices.

Abstract: Described here are devices, systems, and methods for improving blood flow in a vessel. Generally, the method may comprise advancing a catheter into a first vessel proximal to an occlusion in the first vessel and forming a fistula between the first vessel and a second vessel. This may deliver blood flow around an occlusion to ischemic tissues located in the peripheral vasculature.

Abstract: An arteriovenous (AV) graft is disclosed than includes portions for inserting hemodialysis needles. The AV graft includes two spaced portions that are each adapted for receiving needles. These portions may have a different shape or rigidity than other portions of the AV graft. A care giver may be able to palpate the location of the two spaced portions, thus facilitating hemodialysis by providing the needles to locations on the AV graft adapted to accept the needles. Methods of providing hemodialysis using the AV graft are also described.

Abstract: A method of providing retrograde perfusion of a patient's brain includes occluding a jugular vein of a subject at a jugular occlusion location, and passively shunting arterial blood from an artery of the subject to a location in the jugular vein distal to the jugular occlusion location.

Abstract: Devices and methods for treating intraocular pressure are disclosed. The devices include shunts for draining aqueous humor from the anterior chamber to the uveoscleral outflow pathway, including the supraciliary space and the suprachoroidal space. The shunts are preferably implanted by ab interno procedures.

Abstract: An implantable artificial bronchus (IAB) is provided that is used for the treatment of chronic obstructive pulmonary diseases, such as pulmonary emphysema. The implantable artificial bronchus can be made with silicone or nitinol, and has a tapered cylindrical shape. Additional embodiments of this apparatus may be further associated with a one-way valve, on the nozzle of the IAB.

Abstract: An apparatus (10) for controlling flow of fluid from a wound site of a patient may include a chamber (28) connectable to a wound site and a reservoir (16). The chamber (28) may have a first deformed state, and a second state in which it is not deformed or less deformed than in the first state. The chamber (28) may be adapted to manage fluid flow between the wound site and the reservoir (16) during transition of the chamber (28) between the first state and the second state. An actuator element (64) of the apparatus (10) may be adapted to operate on the chamber (28) to transition the chamber (28) from the second state to the first state.

Abstract: A microsurgical bipolar forceps may include an actuation structure, a hypodermic tube, a first electrical conductor, and a second electrical conductor. The actuation structure may include an actuation structure distal end, an actuation structure proximal end, and a plurality of actuation limbs. The hypodermic tube may be disposed in the actuation structure. The first electrical conductor may be disposed in the hypodermic tube and the actuation structure wherein the first electrical conductor is electrically connected to a bipolar cord. The second electrical conductor may be disposed in the hypodermic tube and the actuation structure wherein the second electrical conductor is electrically connected to the bipolar cord. A compression of the actuation structure may be configured to decrease a distance between a first jaw of the first electrical conductor and a second jaw of the second electrical conductor.

Abstract: A device for implanting in a gastrointestinal system of a patient may include an elongate flow modulator configured to be inserted in an intestine, wherein the flow modulator defines an enclosed interior space to hold a fill material.

Abstract: Systems and methods for implanting an endovascular shunt in a patient is disclosed. The system having an expandable anchor configured for being deployed in a dural venous sinus of a patient at a location distal to a curved portion of a wall of an inferior petrosal sinus (IPS) of the patient; an elongate guide member coupled to, and extending proximally from, the anchor; a shunt delivery catheter having a first lumen configured to receive the guide member, and a second lumen extending between respective proximal and distal openings in the shunt delivery catheter, the shunt delivery catheter further having a penetrating element coupled to a distal end of the catheter; and the system further having a guard at least partially disposed over, and movable relative to, the penetrating element.

Abstract: The invention relates to a stainless steel device for permanent insertion into the sclerocorneal limbus, with different drainage and anchorage systems, enabling the aqueous humour to discharge through one or more virtual spaces from the anterior chamber to an intrascleral space in cases of simple glaucoma or to the equatorial episclera in cases of complex glaucoma, such as neovascular glaucoma. The space is virtual, not real, as in the case of the tubular device. It enables the aqueous humour to discharge slowly and continuously, minimizing the possibility of the chamber being flat or of germs penetrating through the device. Furthermore, the anchorage system is less aggressive, thus reducing the possibility of bleeding.

Abstract: An implantable device for treatment of glaucoma of the eye. In one aspect, the device includes an elongate duct for diverting aqueous humor from the anterior chamber of the eye, the elongate duct having a central axis with a proximal end and distal end opposite one another. A least one element is spaced apart from the proximal end and the distal end of said elongate duct and extends radially outward beyond an outer surface of said elongate duct in at least two directions transverse to the central axis of said elongate duct, wherein the at least one element has a distal portion with a tapered profile facing the distal end of said elongate duct. The at least one element is configured to deform in a tissue passage leading into the anterior chamber of the eye as it is inserted into the tissue passage in response to forces applied by surrounding ocular tissue of the tissue passage. Other aspects are also described and claimed.

Abstract: A system for preparation of an implant and ab interno insertion of the implant into an eye including a handle having one or more actuators and an elongated shaft having an outer sheath and an elongate member positioned within a lumen of the tubular outer sheath. The system includes a recess sized for holding a patch of material fixed relative to the handle and a cutting member movable relative to the handle and to the recess. The cutting member cuts the patch of material into an implant as the cutting member moves towards a cutting configuration. The implant, once cut, is axially aligned with the lumen of the tubular outer sheath. The inner elongate member is movable relative to the tubular outer sheath to advance the implant into a deployment position in the lumen of the tubular outer sheath for delivery into the eye. Related devices and methods are provided.

Abstract: The present invention relates to an implant, to an instrument for implantation of the latter and to a method for manufacturing this implant which includes an elongated body (10) between a free end and a head (18) along a longitudinal axis on the one hand and turns (12) of at least one threading on at least one portion of said body (10) in proximity to the free end, along the longitudinal axis on the other hand, characterized in that the body (10) includes a longitudinal internal conduit (11) in at least one portion along the longitudinal axis, obtained by at least one first central machining operation parallel to the longitudinal axis and at least one second machining operation in a so-called transverse plane, not parallel to the longitudinal axis and crossing the wall of the body (10) as far as the longitudinal internal conduit (11) by making windows (15) communicating between said longitudinal internal conduit (11) and the outside of the body (10).

Abstract: A delivery system for delivering an implant to a first space within a body of a patient including an elongate delivery member having a proximal portion, a distal portion, a lumen and a receiving area, the receiving area dimensioned for receipt of the implant. A deforming member is movable with respect to the delivery member from a first position to a second position to apply a force to the implant to deform the implant positioned in the receiving area of the delivery member.

Abstract: The present invention relates to a connection stent and a method of manufacturing the stent. The connection stent includes: a body configured to form a plurality of cells through the intersection of wires, and provided in a hollow cylindrical shape; an upper head formed to extend from one end of the body to have a diameter larger than that of the body; and a lower head formed to extend from a remaining end of the body to have a diameter larger than that of the body. The upper head and the lower head are respectively placed to come into contact with insides of heterogeneous tissues. Accordingly, according to the present invention, there can be manufactured a stent which can connect heterogeneous tissues and form a bypass and which can provide sufficient expansion force and minimum axial force for the maintenance of the bypass formed as described above.

Abstract: A high-flow luer lock connector is disclosed. A high-flow luer lock connector comprises a connector body defining an interior region, a lumen, and an extended passageway. The interior region is bounded by a cylindrical side wall and a base wall. The lumen is defined at the base wall of the interior region and extends no more than 0.274 of an inch into the interior region. The extended passageway comprises a first and second end and passes through the connector body and the lumen. The extended passageway is in communication with the interior region to allow insufflation gas to flow through the interior region and extended passageway.

Abstract: An implantable device for treatment of glaucoma of the eye. In one aspect, the device includes an elongate duct for diverting aqueous humor from the anterior chamber of the eye, the elongate duct having a central axis with a proximal end and distal end opposite one another. A least one element is spaced apart from the proximal end and the distal end of said elongate duct and extends radially outward beyond an outer surface of said elongate duct in at least two directions transverse to the central axis of said elongate duct, wherein the at least one element has a distal portion with a tapered profile facing the distal end of said elongate duct. The at least one element has a hardness within a range between Shore 30A and Shore 80A. Other aspects are also described and claimed.

Abstract: A prosthesis has a tubular body having a proximal end, a distal end, and a lumen extending through the tubular body and open at each of the proximal end and the distal end. The tubular body defines a longitudinal axis and has a first width in a direction perpendicular to the longitudinal axis. The prosthesis also includes a first flange at one of the proximal end and the distal end with the lumen extending through the first flange. The first flange has a second width in the direction perpendicular to the longitudinal axis that is greater than the first width. The tubular body and the first flange form a structurally self-supporting, body compatible, and body absorbable device. The device is formed of a composite structure and is adapted for insertion into an opening through a tympanic membrane.

Abstract: A self-sealing vascular graft, including a substrate with a sealant layer and several optional additional layers, is described. The substrate can be ePTFE and the material used for the sealant and additional layers can be polyurethane. The sealant layer and additional layers may include one or more base layers, one or more foam layers, beading of different sizes and shapes, and ePTFE tape. A flared cuff may be integral to one or both ends of the substrate or may be attached to one or both ends. Various methods of making a self-sealing vascular graft are also described, including methods of disposition, methods of forming, methods of bonding and methods of attaching.

Abstract: Shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma by diverting excess aqueous humor from the anterior chamber of the eye into Schlemm's canal where post-operative patency can be maintained with an indwelling shunt device which surgically connects the canal with the anterior chamber. The shunt devices provide uni- or bi-directional flow of aqueous humor into Schlemm's canal.

Abstract: A ventricular assist device includes a pump including a housing having an inlet, an outlet and a moveable element disposed in the housing for urging blood from the inlet to the outlet. An outflow cannula having a proximal end attached to the pump housing, a distal end remote from the pump housing, an interior bore in communication with the outlet of the pump housing, and at least one outlet aperture communicating with the interior bore remote from the pump housing is included. At least one sensor mounted to the outflow cannula and configured to detect a parameter of blood flowing at least one from the group consisting of through the outflow cannula and about an exterior of the outflow cannula is included.

Abstract: A fluid jet is directed at tissue to erode tissue with a controlled amount of ablative energy of a jet. Embodiments as described herein can provide controlled removal of ocular tissue, and can remove a pre-defined volume having a pre-determined shape, for example. The accurate tissue removal as described herein can have many applications, such as removal of the lens for cataract surgery to more completely remove the cortex and nucleus of the lens and to separate layers of the lens. The length of an ablation depth extending from an opening that releases the jet can be controlled, and the angle and longitudinal position of the opening can be controlled together, in order to ablate a pre-determined volume of tissue having the surface profile.

Abstract: Disclosed herein are systems and methods for aiding a surgeon to perform a surgical procedure on an eye. The surgical procedure includes inserting an elongate probe from an opening into the eye across an anterior chamber to a target tissue region comprising a trabecular meshwork and a Schlemm's canal. Exemplary systems include an optical microscope for the surgeon to view the eye with a microscope image during the procedure; an optical coherence tomography (OCT) apparatus configured to perform an OCT scan of a target location in the target tissue region during the procedure; and an image processing apparatus configured to generate an augmented image by overlaying an OCT image of target location and a graphical visual element identifying the locations, wherein the graphical visual element is registered with the microscope image to aid the surgeon in advancing a distal end of the elongate probe to the target location.

Abstract: An endovascular catheter combination configured to have multiple capabilities is disclosed. These capabilities include proximal and distal occlusion of a segment of a target blood vessel (such as the carotid artery) thus excluding the segment of the blood vessel from circulation for purposes such as surgical consideration. Another capability includes intravascular shunting of the blood through the excluded portion of the artery during a procedure such as an endarterectomy. Additionally, a microsensor provides a measurement of the rate/volume of blood flow through the distal end of the catheter. In one embodiment, a guidewire is provided with a filtration mesh as an anti-embolic mechanism both at the time of initial positioning of the catheter and after reversing the occlusion.

Abstract: Methods and systems for performing an ophthalmic surgical treatment procedure include one or more wicking members to secure a volume of treatment fluid to a distal end of a surgical instrument. Such a surgical instrument may include an elongate tubular member having a proximal end, a distal end, and a lumen extending therebetween, the elongate tubular member being configured to penetrate a body cavity of a patient. The instrument may further include a wicking member extending beyond the distal end of the elongate tubular member. The wicking member may be configured to secure a volume of treatment fluid delivered through the lumen to the wicking member for application from the wicking member to target tissue in the body cavity.

Abstract: Various embodiments of the present invention provide a conduit system including an outer lumen, an inner lumen, and an attaching device. In other embodiments, a multiple access port device adapted for communication with at least one of an outer lumen, an inner lumen, or an attaching device of a conduit system is provided. In yet other embodiments, a system including an inner lumen that is collapsible is provided. Means for closing a conduit system are also provided, including a plug for insertion through an attaching device and a variable radius coiled member associated with an attaching device.

Abstract: Shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma by diverting excess aqueous humor from the anterior chamber of the eye into Schlemm's canal where post-operative patency can be maintained with an indwelling shunt device which surgically connects the canal with the anterior chamber. The shunt devices provide uni- or bi-directional flow of aqueous humor into Schlemm's canal.

Abstract: Systems and methods are provided herein that generally involve shunting fluid, e.g., shunting cerebrospinal fluid in the treatment of hydrocephalus. Self-cleaning catheters are provided which include split tips configured such that pulsatile flow of fluid in a cavity in which the catheter is inserted can cause the tips to strike one another and thereby clear obstructions. Catheters with built-in flow indicators are also provided. Exemplary flow indicators include projections that extend radially inward from the interior surface of the catheter and which include imageable portions (e.g., portions which are visible under magnetic resonance imaging (MRI)). Movement of the flow indicators caused by fluid flowing through the catheter can be detected using MRI, thereby providing a reliable indication as to whether the catheter is partially or completely blocked.