Abstract: A vascular access device may include a blood circuit having an arterial blood line and a venous blood line. The venous blood line is connected to a first access needle and the arterial blood line is connected to a second access needle. The venous blood line is connected to an access component affixed to the second access needle and configured such that when the second access needle is used to infuse blood into a patient, the access component is positioned to withdraw blood and convey it into the venous line. The withdrawn blood may also be conveyed to an air detector to detect withdrawal of the second access needle.

Abstract: The present technology is generally directed to implantable medical devices and associated methods. For example, a system configured in accordance with embodiments of the present technology can include a body implantable into a patient and configured to undergo a shape change, the body having a conductive path with variable conductivity in portions thereof for selective and/or preferential heating. The body can be coupled with an energy source that can delivery energy to the body and/or conductive path, to promote the shape change in the body.

Abstract: The present invention relates to an implant device for an eye disease for adjusting intraocular pressure. An implant device for an eye disease for adjusting the intraocular pressure according to an embodiment of the present invention comprises: a first tube into which the aqueous humor flows so as to adjust the intraocular pressure; and a second tube formed inside the first tube. The second tube is made of a biodegradable material configured to be degraded inside the eye over a predetermined period of time after being inserted into the eye. The first tube and the second tube may be divided into a first area and a second area according to the distance from the anterior chamber of the eyeball. The second area of the first tube and the second tube may have such a structure that the diameter thereof is larger than that of the first area of the first tube and the second tube, and the same can expand as the aqueous humor flows in.

Abstract: Methods and devices for controlling blood perfusion pressure along with regional mild hypothermia. In at least one embodiment of a device for controlling blood perfusion pressure within a vessel of the present disclosure, the device comprises an elongated body having a lumen, a proximal end configured for placement in a first area having a first blood pressure, and a distal end configured for placement in a second area having a second blood pressure, a partial occluder positioned within the lumen of the elongated body between the proximal end and the distal end, the partial occluder configured so not to fully occlude a blood vessel and to equalize the first blood pressure at the first area with the second blood pressure at the second area, and a regional hypothermia system operably coupled thereto, the regional hypothermia system operable to reduce and/or regulate a temperature of a bodily fluid flowing therethrough.

Abstract: System and method to improve drug delivery to identified regions in the brain or elsewhere through direct infusion of a therapeutic agent or the like into that region. This direct infusion will allow for greater concentrations of the agent in the target region while reducing concentrations elsewhere in the body where these agents may be toxic. The system and method improves efficacy while reducing unwanted side effects. The system includes an array of multiple, independently targeted, microporous catheters for insertion into the target region and a distribution system that allows for individualized flow control to each catheter. The system may be connected to a reservoir that contains the therapeutic agent, and flow to the system is maintained through one or more pumps. This system will greatly improve on the current single catheter infusion design and shall provide therapy, delivered through multiple catheters, thus delivering the therapy evenly over a customizable volume.

Abstract: A combination bioactive silicate (e.g., bioactive glass) medicine carrier and shunt of one embodiment includes a shunt which is a tubular member made of bioactive silicate or glass being adapted to be bioresorbable and water soluble, or fiber bundle, the shunt including an insertion end at a first end. Gaps in the bioactive silicate or gaps in the glass adapted to be bioresorbable and water soluble are served as at least one storage for storing medicines.

Abstract: An implantable externally driven fluid delivery system for localized delivery of medical agents and drugs, such as antibiotics, may be provided herein. The fluid delivery system includes a housing that incorporates a filling septum connected to a flexible internal reservoir. The reservoir is connected to a miniature diaphragm pump with coupled magnetic components. The entire fluid delivery system is implantable into a body cavity or surgically formed location that provides for local medical agent delivery. The reservoir is filled via percutaneous injection through the skin into the septum. Fluid delivery is achieved through proximity of the external controller that generates an oscillating or reversing magnetic field suitable to actuate the pump's diaphragm resulting in controlled fluid flow. Once local drug delivery treatment is complete, the controller can be discarded.

Abstract: An apparatus is provided for draining aqueous humor from an eye for reducing intraocular pressure. The draining apparatus comprises a tube defining a passage for fluid flow between an inlet end and an outlet end. An outlet assembly contacts the conjunctival layer externally of the eyeball. The outlet assembly comprises a housing in fluid communication with the outlet end of the tube and having an aperture for allowing egress of aqueous humor onto the external ocular surface. A resistive component is disposed in the housing for providing resistance to a flow of aqueous humor. A pair of tabs project outwardly and are adapted to be disposed subconjunctivally for securing the draining apparatus relative to the eyeball.

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 including a flow control assembly. The system may include a flow regulating shunt system, for various purposes such as a use as a hydrocephalus shunt. The flow control assembly may be controlled according to selected parameters and methods. These include controlling microelectromechanical (MEMS) system to control a pressure in the flow control assembly.

Abstract: An implantable device for the treatment of hydrocephalus using a stent having a peripheral wall and an interior passageway and wherein a plurality of microneedles project outwardly from the peripheral and each needle includes a microneedle passageway from an aperture adjacent a distal end of the microneedle to a proximal end of the microneedle adjacent the peripheral wall. A corresponding plurality of one-way microvalves is positioned at the proximal ends of the microneedle and wherein the microneedle passageway is in fluid communication with the interior passageway whenever the one-way microvalve is open. When the stent is implanted in the superior sagittal sinus with the distal end of the plurality of microneedles positioned within the subarachnoid space and at least one of the plurality of microvalves is open, the stent permits cerebrospinal fluid to pass from the subarachnoid space to the superior sagittal sinus.

Abstract: An aqueous humor outflow device includes an arcuate scaffold that fits within a conventional aqueous humor outflow pathway of a mammalian eye to receive aqueous humor from a trabecular meshwork of the mammalian eye and allow flow of the aqueous humor through the arcuate scaffold to one or more collector channels that originate in a posterior wall of a Schlemm's canal. The arcuate scaffold includes a first arcuate rail, and a second arcuate rail spaced apart from, and substantially parallel to, the first arcuate rail. The first and second arcuate rails each have an anterior edge that is adjacent to the trabecular meshwork when inserted in the Schlemm's canal, and a posterior edge that is adjacent to the posterior wall of the Schlemm's canal. Structural components coupled to the first arcuate rail and the second arcuate rail maintain the respective anterior and posterior edges of the first and second arcuate rails spaced apart from, and substantially parallel to, each other.

Abstract: Systems and methods for the intravascular treatment of clot material within a blood vessel of a human patient are disclosed herein. A method in accordance with embodiments of the present technology can include, for example, positioning a distal portion of a catheter proximate to the clot material within the blood vessel. The method can further include coupling a pressure source to the catheter via a tubing subsystem including a valve or other fluid control device and, while the valve is closed, activating the pressure source to charge a vacuum. The valve can then be opened to apply the vacuum to the catheter to thereby aspirate at least a portion of the clot material from the blood vessel and into the catheter.

Abstract: Described herein are reusable surgical needles having a resiliently collapsible rear loop that captures a suture as it is passed through an object and resiliently expands upon exiting the object to release the suture. Also described are suture spool assemblies that include a rigid housing and a rotatable spool of suture material suspended within the housing so that a plurality of sutures can be dispensed from the assembly in succession during a surgery. Also described are annular pledgets having diametrical dimensions similar to an outer ring of a cardiac implant such that a single annular pledget can be used with a plurality of sutures that secure the cardiac implant to native tissue around the perimeter of the cardiac implant. Related methods of suturing cardiac implants are also disclosed.

Abstract: A pump (10) includes: a flat plate (20); a piezoelectric element (21); a flat plate (30); a side wall (40); a support member (22); a support member (32); a shielding plate (500); a ventilation hole (23); a ventilation hole (33); a film valve (61); and a film valve (62). The film valve (61) is arranged in a region where the flat plate (20) and the shielding plate (500) face each other. The film valve (62) is arranged in a region where the flat plate (30) and the shielding plate (500) face each other. A center side of one of the film valve (61) and the film valve (62) is fixed in a state in which an outer edge side is movable, and the outer edge side of the other is fixed in a state in which the center side is movable.

Abstract: A trans-anastomotic insertion device includes a body having a distal portion, a proximal portion, and a central portion. The distal portion has a blunt distal end, a width that decreases from its distal end to its proximal end, and longitudinal ribs that provide rigidity to the distal portion. The central portion has a circular configuration and includes a proximally facing surface that includes protrusions that are positioned to be received within staple pockets of a reload assembly of a stapling device. The proximal portion includes a central post that includes splines that are received between splines on a shell housing of a stapling device. The configuration of the insertion device provides added strength to the insertion device to resist high torsional forces that may be applied to the insertion device during insertion of a surgical device through an incision into a body cavity.

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: A medical implant includes a sensor that detects electromagnetic waves; and a data transmission unit that can wirelessly transmit data supplied by the sensor to a receiving unit.

Abstract: An automatic pump-based fluid management system, as described herein, comprises an intercostal pump that is, generally, a resiliently flexible bulb having an inlet and an outlet. The inlet is attached to a first tube that extends from the intercostal pump to a first area of a patient's body, for example, the patient's pleural cavity. The outlet is connected to a second tube that extends from the intercostal pump to a second area of a patient's body, for example, the patient's peritoneal cavity. In use, the intercostal pump is placed between a first rib and a second rib in a patient. The intercostal pump operates by being successively compressed and decompressed between the first and second ribs as the patient breaths.

Abstract: Methods and devices for trans-jugular carotid access are disclosed. Methods within the scope of this disclosure include methods of trans-jugular carotid access originating in the leg of a patient or other location remote to the jugular vein and carotid artery and methods originating at the neck of a patient. Devices used in connection with the disclosed methods may comprise access catheters, lumens, and stylets.

Abstract: Disclosed are implantable ocular drainage devices that include a reversible switch mechanism to control flow through the drainage device. The devices include a drainage tube and a reversible, bi-stable switch mechanism that includes first and second stationary magnets spaced apart from one another and a magnetic or ferromagnetic mobile element moveably disposed in a channel in the housing.

Abstract: Described herein is the use of CSF, more particularly external CSF or CSF-like compositions for the treatment and prevention of different diseases. More particularly, the application provides for the administration of CSF to the intrathecal space or the cerebral ventricles of a patient to increase intracranial pressure and/or CSF flow.

Abstract: Drainage devices and microactuator systems adapted to be incorporated into drainage devices to provide a self-clearing capability for reducing obstructions in the drainage devices and/or a self-monitoring capability to confirm the overall operating condition of the drainage devices and their microactuators. Such a microactuator system includes a microactuator having a base, a cantilever comprising a flexure extending from the base and a plate structure at a distal end of the flexure, a sensing element on the flexure for sensing deflection of the cantilever, and a device for inducing an oscillating deflection of the cantilever relative to the base.

Abstract: The present technology is directed to adjustable shunts for treating glaucoma. In particular, some embodiments provide shunts having a plurality of individually actuatable flow control elements that can control the flow of fluid through associated ports and/or flow lumens. For example, each individually actuatable flow control element can be actuated to block and/or unblock a corresponding port and/or flow lumen. Accordingly, the shunts described herein can be manipulated into a variety of configurations that provide different drainage rates based on whether the ports and/or flow lumens are blocked or unblocked, therefore providing a titratable glaucoma therapy for draining aqueous from the anterior chamber of the eye.

Abstract: An enteral feeding apparatus includes a pod having an expansile pouch which defines a reservoir for enteral fluid and a gas impermeable barrier surrounding the pouch. The pod has an inlet port for delivery of enteral fluid into the pouch and an outlet port having a seal which is pierceable to release enteral fluid from the pouch for delivery to a PEG via a feeding line. The expansile pouch provides the sole force by which enteral fluid is delivered from the pouch through a regulator. The system can accommodate a range of enteral fluids with a wide range of viscosities.

Abstract: A shunt for draining ocular fluid of one embodiment includes a tubular body formed of a mesh material including bioactive glass fiber and collagen, the tubular body including an implantation member and a conduit through the implantation member. The implantation member and the conduit are formed integrally. Other embodiments are also contemplated.

Abstract: Brain drainage device having a rod-shaped hollow body with an inner drainage channel for insertion through the cranium into the brain, a first sensor arrangement with at least one sensor for measuring a physical parameter, and a signal interface; wherein the rod-shaped hollow body has a first region A which, in the applied state, is designed to protrude into the ventricle situated in the brain; wherein the rod-shaped hollow body has a second region B, which is arranged proximally from the first region, wherein the second region is designed to lie in the region of the brain mass in the applied state; wherein the first sensor arrangement is arranged in the second region in order to measure a physical parameter of the brain mass; wherein the first sensor arrangement is connected to the signal interface such that measurement data determined by the first sensor arrangement are transmitted to a measuring system that is to be connected.

Abstract: In some examples, an aspiration catheter system includes an outer catheter and an inner catheter configured to be positioned within the outer catheter lumen, and an alignment element. The outer catheter defines an outer catheter lumen and an outer catheter distal opening. The inner catheter defines an inner catheter lumen, an inner catheter distal opening, and a plurality of sidewall openings proximal to the inner catheter distal opening. The alignment element is configured to indicate a predetermined position of the inner catheter relative to the outer catheter when the inner catheter is received within the outer catheter distal opening. When the inner catheter is at the predetermined position, at least one sidewall opening of the plurality of sidewall openings remains positioned within the outer catheter lumen and at least one other sidewall opening of the plurality of sidewall openings is positioned distal to the outer catheter distal opening.

Abstract: An ocular device for treating glaucoma in an eye are described herein. The ocular device includes a first end, a second end, and a body. The first end is configured to seat in an anterior chamber of an eye. The first end includes an inlet configured to facilitate an ingress of aqueous humor into the ocular device. The second end is configured to seat in a tear film of the eye. The second end includes an outlet configured to facilitate release a flow of the aqueous humor into the tear film. The body is defined by a fluid conduit. The body includes a lumen having a lumen length and a lumen cross sectional area. The lumen length and the lumen cross sectional area are configured to control an intraocular pressure (IOP) of the eye by controlling the flow of the aqueous humor through the lumen.

Abstract: A cerebral spinal fluid shunt plug includes a shunt plug housing having a shunt valve recess formed therein and an intracranial monitoring device recess with an access hole. A shunt valve is positioned within the shunt valve recess of the shunt plug housing and an intracranial monitoring device is passed through the central access hole of the shunt plug housing.

Abstract: A system and related method are provided for draining cerebrospinal fluid from a bodily cavity of a patient, such as a ventricle in the brain in one application. The system includes a reservoir which may be a collapsible container configured for fluidic connection to a shunt located in the bodily cavity. The collapsible container may be an elastically deformable bladder in one embodiment. A pump is fluidly connected to the collapsible container and draws cerebrospinal fluid therefrom. A programmable controller directs the pump to repeatedly activate and deactivate at a predetermined time interval. A plurality of sensors may be provided which are communicably coupled to the controller for monitoring pump motor current draw, tension in the resilient body of the container, pressure, and orientation of the patient. The controller is configurable to deactivate the pump when abnormal operating conditions are detected by the sensors.

Abstract: A glaucoma aqueous humor drainage device and a glaucoma aqueous humor drainage method, wherein the opening and closing of a pressure valve is controlled by the change in the pressure in a cavity of the valve. When the pressure in the intraocular pressure exceeds 12 mmHg, the valve is opened, and a drainage tube connected behind the valve drains the aqueous humor to the ocular surface, reducing the patient's discomfort and dry eyes, effectively draining the aqueous humor and avoiding scarring caused by embedding the device via a conjunctival flap and operation failure caused by increase of intraocular pressure caused by generation of filtering blebs.

Abstract: A device for use in pressure sensing such as hydrocephalus shunts, having a housing enclosing a chamber with at least one port communicating with the chamber. A wall of the chamber includes a flexible portion or thin diaphragm that deflects with transitions in pressure to contact an upstand structure of the housing. A pressure sensor is contained within an enclosure sealed from the chamber by a flexible membrane and which receives fluid pressure from the chamber. This arrangement allows for calibration of the device by identifying a knee feature in pressure data associated with the diaphragm making contact with the upstand.

Abstract: Drainage devices are provided for draining aqueous humor present in the anterior chamber of an eyeball. Such devices include a drainage tube extending axially along a tube axis between a distal end and a proximal end. The distal and proximal ends are at least partially open and are beveled in the same direction. A support flange extends from the proximal end of the drainage tube and includes a plate-shaped portion having an upper surface and a lower surface. The proximal end of the drainage tube is sloped so as to make its opening face the upper surface of the plate-shaped portion. Methods for draining aqueous humor present in the anterior chamber of an eye are also provided.

Abstract: An improved method and device are provided for forming and/or maintaining a percutaneous access pathway. The device generally comprises an access pathway and attachment device. The provided assembly substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.

Abstract: Devices, methods and kits are described for reducing intraocular pressure. The devices include a support that is implantable within Schlemm's canal and maintains the patency of the canal without substantially interfering with transmural fluid flow across the canal. The devices utilize the natural drainage process of the eye and can be implanted with minimal trauma to the eye. Kits include a support and an introducer for implanting the support within Schlemm's canal. Methods include implanting a support within Schlemm's canal, wherein the support is capable of maintaining the patency of the canal without substantial interference with transmural fluid flow across the canal.

Abstract: A minimally invasive system for monitoring and treating high intracranial pressure levels resulting from traumatic brain injury comprises an intravenous access device, an elongate member, a console, and an aspiration and injection catheter. The system is capable of monitoring pressure levels and relocating fluid from the brain to another part of the patient's body to sustain overall constant fluid volume. The method of using the minimally invasive system is also described.

Abstract: A method for treating glaucoma with an implantable glaucoma device includes inserting a hollow elongated needle into the eye between the cornea and iris and into the anterior chamber of the eye to form a needle tract in the eye, introducing a distal end of a guidewire through the needle and into the anterior chamber, introducing a snare through a corneal incision into the anterior chamber. The snare has a sheath and a hook or loop inside the sheath and extendible therefrom. The method includes capturing a segment of the guidewire proximate the distal end of the guidewire with the snare within the anterior chamber, removing the needle from over the guidewire outside of the eye, coupling a glaucoma drainage device to a proximal end of the guidewire that extends outside of the eye, and pulling on the captured guidewire segment with the snare to pull the glaucoma drainage device into the needle tract and into the anterior chamber of the eye until the glaucoma device is located in an implanted position in the eye.

Abstract: The catheter device comprises a drive shaft connected to a motor, and a rotor mounted on the drive shaft at the distal end section. The rotor has a frame structure which is formed by a screw-like boundary frame and rotor struts extending radially inwards from the boundary frame. The rotor struts are fastened to the drive shaft by their ends opposite the boundary frame. Between the boundary frame and the drive shaft extends an elastic covering. The frame structure is made of an elastic material such that, after forced compression, the rotor unfolds automatically.

Abstract: A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particularly in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation mechanism may be provided, to remotely activate the adjustable flow regulation mechanism.

Abstract: The present technology relates to interatrial shunting systems and methods. In some embodiments, the present technology includes interatrial shunting systems that include a shunting element having a lumen extending therethrough that is configured to fluidly couple the left atrium and the right atrium when the shunting element is implanted in a patient. The system can also include an energy receiving component for receiving energy from an energy source positioned external to the body, an energy storage component for storing the received energy, and/or a flow control mechanism for adjusting a geometry of the lumen.

Abstract: Drainage systems for excess body fluids and associated methods are disclosed herein. A body fluid drainage system in accordance with an embodiment of the present technology, for example, can include a catheter that has an exterior surface, a proximal portion, and a distal portion opposite the proximal portion. The body fluid drainage system can further include a valve device, a pressure sensor, and a controller operatively coupled to the valve device and the pressure sensor. The valve device can include an actuator positioned over the exterior surface of the catheter. The actuator is movable between an open position that allows body fluid flow through the catheter, a closed position that at least substantially obstructs the body fluid flow through the catheter, and intermediate positions that partially obstruct the body fluid flow through the catheter. The controller can change the position of the actuator in response to a predetermined condition of the pressure sensor.

Abstract: An implanted intraocular shunt can be manually manipulated, without surgical intervention, to modify the flow resistance of the shunt, thereby providing relief from high intraocular pressure while avoiding hypotony. For example, through application of pressure along a surface of the eye, a portion of the shunt can be displaced or separated relative to the shunt, thereby decreasing a flow resistance of the shunt.

Abstract: A drive mechanism for an insertion mechanism for an administering device, having a base and a guide track. A slider of the drive mechanism provided on the base in a rotationally fixed manner can be slid along or in the guide track between end positions. A drive wheel is rotatably mounted on the base. A drive track is connected to the slider and has a plurality of drive sections, and an energy source, by means of which the drive wheel can be set into rotation. Upon rotation of the drive wheel, the slider moves along the guide track in the distal direction to a distal end of the guide track and slider is moved along or in the guide track in the proximal direction. The energy source can be coupled to the drive wheel by means of a one-piece or multi-piece transmission element and of an introduction wheel.

Abstract: A device and associated method for adjusting the opening pressure of an implantable valve. The valve has a rotor of rotation axis, whose angular position determines the opening pressure. The rotor has a rotor micro-magnet movable between positions of locking and unlocking, in which positions the micro-magnet respectively prohibits and permits the rotation of the rotor. The method includes: arranging a locator to align an axis of a locator receptacle with the rotation axis and to orient the locator in an angular position; determining the angular position of the rotor about its rotation axis with respect to the locator; inserting an actuator into the locator receptacle as far as a first insertion depth; partially withdrawing the actuator from the locator receptacle as far as a second insertion depth less than the first insertion depth; rotating the actuator starting from the second insertion depth; separating the actuator from the valve.

Abstract: Adjustable flow glaucoma shunts are disclosed herein. In one embodiment, for example, an adjustable flow shunt can include an outflow drainage tube having a proximal inflow region and a distal outflow region. The proximal inflow region can include aperture(s) defining a fluid inlet area positioned to allow fluid to flow therethrough. The shunt further comprises an inflow control assembly at the proximal inflow region. The inflow control assembly can include a control element configured to slidably engage the proximal inflow region and a spring element. The spring element is configured to be activated by non-invasive energy and, upon activation, slidably move the control element along the proximal inflow region such that (a) the one or more apertures are accessible and have a first fluid flow cross-section or (b) the one or more apertures are at least partially covered by the control element and have a second, different fluid-flow cross-section.

Abstract: Systems and devices for facilitating the flow of fluid between a first body region and a second body region are disclosed herein. The devices generally include a drainage and/or shunting element having a lumen extending therethrough for draining or otherwise shunting fluid between the first and second body regions. Further, devices configured in accordance with the present technology may be selectively adjustable to control the amount of fluid flowing between the first and second body regions. In some embodiments, for example, the devices comprise an actuation assembly that drives movement of a flow control element to modulate flow resistance through the lumen, thereby increasing or decreasing the relative drainage rate of fluid between the first body region and the second body region.

Abstract: Embodiments described herein include a chipless patterned conductor, comprising one or more glyphs. Each glyph comprises a disk and a ring structure including at least one ring surrounding the disk. One or more of a spacing between the disk and the at least one ring and a width of the at least one ring is configured to determine a characteristic resonant frequency of the glyph. At least one notch is disposed in at least one of the disk and at least one ring of the ring structure. The at least one notch is configured such that the magnitude of resonances in the glyph are dependent on polarization direction.

Abstract: The present teachings provide a device to change the pressure in a chamber of a heart and methods of making and using thereof. One aspect of the present teachings provides a device comprising a frame (for example, a metallic frame) and a scaffold. The frame of the device has a distal flange portion, a shunt portion, and a proximal flange portion. The distal and proximal flange portions can align with the shunt portion and form an elongated first profile. At least one of the distal and proximal flange portions can bend radially away from the shunt portion to form a flange like profile. The scaffold includes one or more than covering layers and encloses parts of the frame or the entire frame. The covering layer provides a barrier between the biological matter and the frame of the device.

Abstract: An implantable intracranial pulse pressure modulator for treating hydrocephalus in patients of all ages is disclosed as well as a system and method for use of the same. In one embodiment of the implantable intracranial pulse pressure modulator, two one-way valves are interposed in parallel, opposing orientations between a vestibule and a chamber. One of the one-way valves, in response to systole, provides fluid communication from the vestibule to the chamber such that a small aliquot of cerebrospinal fluid (CSF) is displaced from a cerebral ventricle into a ventricular catheter, thereby reducing intraventricular systolic pressure. The other one-way valve, in response to diastole, provides fluid communication from the chamber to the vestibule such that the same volume of CSF is reintroduced into a cerebral ventricle, thereby increasing intraventricular diastolic pressure. Together, both processes work synergistically to reduce intraventricular pulse pressure in order to treat hydrocephalus.