Abstract: Methods and devices are adapted for implanting into the eye. An incision is formed in the cornea of the eye and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid passageway. The shunt is passed along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

Abstract: A method is provided for regulating fluid pump pressures by detecting an elevation differential between a fluid flow control device and the distal end of a fluid line in communication with the fluid flow control device. A fluid flow control device, for instance a peritoneal dialysis device, is at a first height, a distal end of a fluid line is at a second height, and a valved outlet, when open, affords communication between the fluid flow control device and the distal end of the fluid line. The elevation differential is correlatable with a pressure measurable during a calibration procedure provided as a part of the methodology.

Abstract: Disclosed are devices and methods of treating an ocular disorder including forming a self-sealing incision in a cornea into an anterior chamber of an eye; introducing through the incision a fluid drainage tube having a distal end, a proximal end and a longitudinal, internal lumen extending through the fluid drainage tube, wherein at least the proximal end passes through the anterior chamber; and implanting the distal end of the fluid drainage tube in fluid communication with the suprachoroidal space such that the proximal end of the fluid drainage tube remains in fluid communication with the anterior chamber.

Abstract: The invention generally relates to devices for deploying an intraocular shunt within an eye. In certain embodiments, devices of the invention include a housing, a deployment mechanism at least partially disposed within the housing, and a hollow shaft coupled to the deployment mechanism, in which the shaft is configured to hold an intraocular shunt, and in which rotation of the deployment mechanism results in deployment of the shunt.

Abstract: Methods and devices are adapted for implanting into the eye. An incision is formed in the cornea of the eye and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid passageway. The shunt is passed along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

Abstract: A glaucoma drainage device has an active valve configured to be located between an anterior chamber of an eye and a drainage location, a power source coupled to the active valve, and a controller coupled to the power source. A first pressure sensor is located in fluid communication with the anterior chamber, a second pressure sensor is located in the drainage location, and a third pressure sensor located remotely from the first and second pressure sensors. The controller reads the first, second, and third pressure sensors once during a period of time and adjusts the active valve to control intraocular pressure.

Abstract: The present invention is thus directed to methods and apparatus for decreasing pressure in a first portion of a vessel of the cardiac structure of a patient by implanting a shunt communicating with an area outside said first portion, whereby a volume of blood sufficient to reduce pressure in said first portion is released.

Abstract: A dialysis valve includes a tube attached between an artery and a vein which, when elongated, simultaneously narrows in diameter at at least one location. The narrowed portion of the tube decreases the volume and velocity between the arterial and venous side of the patient to prevent damage or intimal hyperplasia on the venous side between dialysis treatments. When the valve is opened for dialysis, an unrestricted blood flow exists between the arterial and venous side, permitting a controlled, open blood flow during dialysis.

Abstract: The present invention is thus directed to methods and apparatus for decreasing pressure in a first portion of a vessel of the cardiac structure of a patient by implanting a shunt communicating with an area outside said first portion, whereby a volume of blood sufficient to reduce pressure in said first portion is released.

Abstract: A system and method is provided for the deployment of a ureter between a kidney and a bladder. A stent includes a flexible internal drainage portion, a retention portion, and an external drainage portion. The external drainage portion includes a sharpened tip configured to be passed from through a renal pelvis and out the side of a patient's body from inside the ureter. The stent is arranged to be removable by pulling the external drainage portion and thereby removing the stent out the side of the body.

Abstract: An improved vascular graft having increased patency is disclosed herein. The graft may comprise a central or other stenosis. In addition, in some embodiments, the graft may comprise an internal reservoir and a collapsible portion configured to self-adjust the stenosis based on blood flow pressure. The graft may comprise an endothelial lining, one or more drug eluting materials, or both to increase patency by respectively reducing clots and preventing unwanted cellular or fibrin growth. The endothelial lining may be formed from one or more endothelial cells artificially grown or harvested from a patient's vascular system.

Abstract: An intraluminal device and method includes positioning the intraluminal device, such as a bariatric device, in a lumen that is subject to peristaltic waves, such as the GI tract. The intraluminal device includes a surface defined by a wall having opposite end portions. The surface is configured to generally conform to the shape and size of a portion of the lumen. The end portions are spaced apart along an axis in the direction of peristaltic movement along the lumen. The cover has at least one opening therein between the end portions in order to resist peristaltic waves causing distal migration of the device.

Abstract: Tools for determining and adjusting the setting of an adjustable valve are disclosed. These tools allow a medical professional to locate and non-invasively determine the setting of an implanted valve. After the valve has been located and the setting of the valve determined, the valve may be re-adjusted non-invasively. There are three tools: a locator tool, an indicator tool and an adjustment tool. The locator tool allows the physician to locate the adjustable valve of interest and align the locator tool with a specific orientation of the valve. The indicator tool indicates the current setting of the adjustable valve and confirms new settings of the valve after the new settings have been implemented. The adjustment tool interacts magnetically with the implanted adjustable valve to couple with a movable internal element to change the setting of the valve. The indicator tool and the adjustment tool physically cooperate with the locator tool to accomplish the respective functions of the tools.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: Lacrimal implants for treating diseases or disorders are disclosed. More particularly, lacrimal implants, methods of making such implants, and methods of treating ocular, respiration, inner ear or other diseases or disorders using such implants are disclosed.

Abstract: A fluid flow-regulating system includes an electrolysis chamber configured to contain a liquid, and includes first and second electrodes disposed within the electrolysis chamber. A gap between opposing surfaces is sized to promote capillary action of a liquid in the electrolysis chamber that draws the liquid to at least one of the first and second electrodes in a manner allowing the flow-regulating system to be placed in multiple orientations and still have said one of the first and second electrodes wetted by capillary action.

Abstract: A device for regulating blood pressure in a heart chamber is provided. The device includes a shunt positionable within a septum of the heart. The shunt is designed for enabling blood flow between a left heart chamber and a right heart chamber, wherein the flow rate capacity of the device is mostly a function of pressure in the left heart chamber.

Abstract: Method and apparatus for treatment of morbid obesity by placement of a series of flow reduction elements in the small intestine to induce satiety are disclosed. The flow reduction elements restrict the movement of partially digested food and reduce the flow rate through the small intestine which causes the emptying of the stomach and the duodenum to occur slower. The flow reduction elements are attached to an elongated tube and are constructed from various shapes and configurations. The flow reduction elements may be inflated with fluid or may be constructed from self-expandable materials. The device is anchored in the antrum of the stomach with an anchoring member. The transoral gastric device can be inserted with a delivery catheter through the working lumen of an endoscope or alongside an endoscope and may be removed with the aid of an endoscope if desired.

Abstract: A device for the in situ clearing of blockages in a tube includes a controller and a clearing member. The controller can have a housing and an actuator for generating repetitive motion. The clearing member can be releasably coupled to the controller and suitable for insertion in the tube. The tube can be at least partially disposed within a living being. The controller can be located external to the living being. The clearing member can have a first end releasably coupled to the actuator, at least one flexible section which permits axial displacement of the clearing member, and a second end suitable for repetitively engaging and disrupting the blockage. The flexible section permits the clearing member to repetitively engage and disrupt the blockage within one of a straight and a curved portion of the artificial tube.

Abstract: An IOP control device for implantation in an eye of a patient is disclosed, including a housing with an entrance port and an exit port, a membrane anchored within the housing in a manner forming a flow control chamber on a first side of the membrane and a fluid flow passageway on a second opposing side of the membrane, and a position sensor system. The flow control chamber is arranged to contain a gas creating a flow control chamber pressure, and the membrane is configured to affect flow through the fluid flow passageway from the entrance port to the exit port by deflecting in response to changes in the flow control chamber pressure. The position sensor system includes a first conductive portion and a second conductive portion positioned to selectively contact the first conductive portion to indicate the position of the membrane relative to the fluid flow passageway.

Abstract: An implantable valve system and method of using same, including a housing with a resilient membrane defining a reservoir in fluid communication with at least two ports, and at least a first set of opposing sealing features disposed on upper and lower surfaces within the housing. The membrane is capable of being depressed by a human finger to bring the sealing features together to substantially restrict fluid from passing through at least one of one of the ports, and is capable of being depressed additionally by a rolling motion of the finger to drive fluid through the other of the ports.

Abstract: A device and method for the removal and disposal of transected hair from the body of a patient in an operating room or other sterile location. The hand-held device is single-use, latex-free, sterile-packaged, non-conductive, fully disposable and comprises a hollow handle with a projecting wand ending in an enlarged distal tip. The other end of the hollow handle opposite the enlarged distal tip is connected to a vacuum source, such as the one readily available in most operating rooms, via flexible tubing. When the wand and the enlarged distal tip are passed over transected hair, the hair is suctioned into the hand-held device. The hand-held device includes a particulate filter to prevent the suctioned hair from entering the vacuum system, one or more internal circumferential ribs to create a turbulent flow within the handle, a reservoir to collect transected hair, and venturi apertures to regulate the suction pressure.

Abstract: A method is described for using a postoperative CSF dynamical examination to determine the CSF dynamical state of the patient and the dynamical state of the CSF shunt in conjunction therewith.

Abstract: Disclosed herein is a device for controlling the flow of a body fluid from a first tissue/organ to a second tissue/organ of a subject. The flow control device includes a main body, a first fluid channel, a second fluid channel, a detection member, and a control member. The main body defines a lumen for accommodating the body fluid flowing from the first tissue/organ into the lumen. The first fluid channel is in fluid communication with the lumen and the first tissue/organ; while the second fluid channel is in fluid communication with the lumen and the second tissue/organ. The detection member is in fluid communication with the lumen, and is operable to detect at least one parameter associated with the flow of the body fluid. The control member is operable to control the flow of the body fluid from the first tissue/organ to the second tissue/organ of the subject.

Abstract: In a method for the automatic control of blood pumps, an optimization of the blood flow is achieved by periodic speed interventions and flow changes thereby occurring, using a formed differential variable and a control algorithm. In addition, the location of possible flow resistances on the venous or arterial side can be ascertained.

Abstract: A luminal valve for placing in a body lumen comprises at least four valve leaflets. The valve has a normally closed configuration in which the leaflets are engaged and an open configuration in which the leaflets are open. The valve may be mounted to an esophageal support.

Abstract: An implantable shunt device for draining cerebrospinal fluid from a patient's subarachnoid space includes a shunt having opposed first and second ends and a one-way valve located at the first end of the shunt. A hollow passageway extends between the tip and one-way valve such that fluid can be drained through the tip and out through the valve. The endovascular cerebrospinal fluid shunt of the present invention can be placed into a patient percutaneously via a catheter inserted into the venous system of the body through a needle hole, without the need for open surgery. The device allows for more physiologic drainage of cerebrospinal fluid since the device shunts cerebrospinal fluid into the same cerebral venous system that occurs naturally in normal people.

Abstract: A capillary fluid flow valve may include a chamber having a first boundary surface and a second boundary surface defined by a housing. The first and second boundary surfaces may be spaced apart by a gap sized to invoke capillary action between the surfaces. The first surface may be angled relative to the second surface. The chamber may have an inlet port, an outlet port, and an air vent port. The gap at the air vent port may be smaller than the gap at the outlet port and the gap at the outlet port may be smaller than the gap at the inlet port.

Abstract: A drainage implant is provided for the drainage of aqueous humor. The implant may comprise a collector, a connector and disperser. The collector and/or disperser may be self-expandable and can be held in an unexpanded condition by a delivery device. When positioned for implantation, the collector and disperser are ejected from the delivery device, whereby upon being ejected from the delivery device they can expand to a pre-defined final shape in the desired place. A delivery device for implanting the implant may have a shaft for accommodating the implant and a cutting edge that may be used to create a pocket or reservoir in the tissue where the implant device is to be implanted. Methods of implanting an implant are also disclosed.

Abstract: A method of deploying an ocular implant into Schlemm's canal of an eye. The method includes the steps of inserting a distal end of a cannula through a cornea of the eye and into an anterior chamber of the eye, the cannula having a distal opening extending from the distal end and through a side wall; placing the distal opening of the cannula into fluid communication with Schlemm's canal; advancing the ocular implant distally through the cannula with a delivery tool engaged with the ocular implant, a proximal portion of the ocular implant engaging the delivery tool proximal to a distal portion of the delivery tool; and disengaging the ocular implant and the delivery tool when the proximal portion of the ocular implant reaches the cannula distal opening. The invention also includes a system for practicing the method.

Abstract: Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

Abstract: An ocular implant adapted to reside at least partially in a portion of Schlemm's canal of an eye. The implant includes a spine extending along a longitudinal axis of the implant, a plurality of curved supports extending from the spine, each support comprising a first end extending from a first location on a first side of the spine and a second end extending from a second location on a second side of the spine, the second location being proximal to the first location, so that each support forms a portion of a helix, the spine and supports defining a volume having a maximum width perpendicular to the longitudinal axis between 0.005 inches and 0.04 inches, the ocular implant being configured to bend preferentially in a preferential bending plane.

Abstract: A device for diverting fluid from the ventricles of the brain to another area of the body includes an inlet, an outlet, and a resistance member operatively connected to the inlet and the outlet. The resistance member includes a first plate, a surface of which has a groove which defines a resistance flow channel, an entry of the flow channel being in fluid communication with the inlet and an exit of the flow channel being in fluid communication with the outlet; and a second plate, the second plate being held in abutment with the grooved surface of the first plate so as to define a resistance tube. The resistance tube includes a plurality of arcs arranged in flow series, each arc radially extending between the inner and outer diameters of the first and second plates. A selection mechanism operable to interconnect a selected number of the arcs to the inlet and outlet is provided.

Abstract: A method and toolset capable of remotely moving a rotor of an implanted device in a first arcuate direction and detecting a first limit of travel, moving the rotor in a second, opposite direction and detecting a second limit of travel without altering the current performance setting of the implanted device, comparing the first and second limits of travel with known values for a plurality of selectable performance settings, and indicating the current performance setting of the implanted device.

Abstract: Drainage of aqueous from the anterior chamber of the eye can be facilitated by a malleable hollow clip or staple that can be formed to attach to ophthalmic tissue and provide intra-luminal flow of aqueous through the clip. In addition, the clip can be adjusted to modulate the outflow rate of aqueous, both during the initial surgical procedure as well as on a post-procedure basis. Furthermore, an instrument is described in which the forceps of the clip delivery device reside inside the lumen of hollow clip during deployment and manipulation. Features of an instrument are designed to secure the clip to the delivery forceps and prevent tissue blockage of the clip lumens. The clips may be color-matched to the underlying tissue for the purpose of camouflage and may carry pharmaceuticals.

Abstract: A membrane actuator device includes a housing with an entrance port and an exit port connected by a fluid flow passageway. A gas generation chamber is disposed within the housing, the gas generation chamber comprising a first opening and a gas generating element. A membrane actuation chamber has a second opening and may be defined at least in part by a flexible membrane configured to deflect and affect fluid flow through the fluid flow passageway. A barrier spans the width of the first opening of the gas generation chamber and is disposed in a manner that reduces the likelihood that gas molecules will pass from the gas generation chamber to the membrane actuation chamber.

Abstract: A hemodialytic angioacess device for implantation in dialysis patients, comprising an arteriovenous (AV) shunt, anastomotic valves that connect the AV shunt to blood vessels, a valve control system and an integrated surveillance system that measures flow conditions in the blood vessels at the AV shunt, preferably when the valves are closed and the patient is not undergoing dialysis treatment. The flow condition data, which may include data representing the flow rate, pressure, volume and velocity of blood flowing through the vessels, is stored in a memory and transmitted to a health care provider or technician on demand. The data can be used to calculate and monitor important physiological parameters, such as compliance and resistance, for the blood vessels, and help detect and identify dangerous conditions, such as turbulence and stasis, which can contribute to AV shunt failure, vessel injury and other serious complications for the patient.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: Various embodiments of the present invention provide a conduit system including an outer lumen (810), an inner lumen (805), and an attaching device (820). 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: Disclosed herein are an apparatus, a system, and a method to monitor drainage from a first region of a patient to a second region. The apparatus comprises pressure sensors configured to measure the pressures of the first and second regions, a flow system to regulate drainage of fluid from the first region to the second region, a memory having a stored pressure drop across the flow system; and a processor associated with the memory and configured to compare the first pressure, the second pressure, and the stored pressure drop threshold and selectively generate control signals based on the comparisons. In some instances, the apparatus further comprises an alarm, and the processor is configured to generate the control signals that trip the alarm when a pressure drop exceeds the stored pressure drop threshold.

Abstract: A retrograde flow system is configured for treating an artery. The system includes an arterial access device adapted to be introduced into an artery and receive blood flow from the artery. A shunt fluidly is connected to the arterial access device, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site. A flow control assembly is coupled to the shunt and is adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. A shut-off valve assembly automatically blocks fluid flow through the shunt in response to injection of the fluid into the arterial access device.

Abstract: A distal perfusion sheath (DPS) is provided for cases where blood perfusion is needed for downstream arteries (distal) to the insertion point of the DPS within the target artery. The ability to provide distal perfusion with the DPS allows the DPS to be positioned in the target artery for long periods without causing lack of blood flow (ischemia) to an extremity that the target artery supplies. In certain embodiments, the DPS can still be used for surgical arterial access while allowing blood flow downstream. In addition, embodiments of the DPS configured with longer perfusion shunts can allow a contra-lateral extremity downstream to a large DPS to have blood flow while the sheath is in place.

Abstract: An implant for treating medical disorders includes a first chamber having a flexible outer layer that surrounds a flexible inner layer, a second chamber in communication with the first chamber, and a fluid transfer assembly adapted for transferring fluid between the second chamber and the first chamber for selectively modifying the rigidity of the first chamber. The implant includes at least one restraining element in contact with the flexible outer and inner layers for at least partially restricting volume expansion of the first chamber as the fluid is transferred into the first chamber. The first chamber is adapted to become more rigid as the fluid is transferred into the first chamber and more flexible as the fluid is removed from the first chamber. The first chamber is implantable within the soft tissue of a patient such as a tongue, soft palate, pharyngeal wall, urinary tract, rectum, trachea, or stomach.

Abstract: An implantable medical assembly includes a cover having a porous chamber. Enclosed within the chamber is a medical device through which aqueous body fluid flows from an outlet of the device into the chamber. The chamber is formed at least in part from a porous material that promotes vascularization and inhibits fibrotic encapsulation upon implantation and that allows aqueous body fluid in the chamber to flow through the porous material into body tissue in which the assembly is implanted. The chamber has a pair of walls that are spaced apart at a first portion of the chamber at or near the outlet and converge at a second portion of the chamber downstream of the outlet.

Abstract: When a patient is fitted with an external gastrostomy connection to the stomach, ingested food can be removed through the gastrostomy connection using a pump-based or siphon-based system to achieve weight loss. The process of removing ingested food can be improved by alternating the infusion of liquid into the stomach with the removal of material from the stomach. Optionally, stomach acid may be captured and returned to the stomach. Optionally, nutritional supplements or medicines may be added to the infused liquid. Optionally, a flush mount connectorized system with a built in valve may be used to simplify the interface with the gastrostomy hardware that remains installed in the patient. Optionally, the system may be configured to disable itself from further use after a triggering event (e.g., the passage of time or a predetermined number of uses) has occurred.

Abstract: A distal perfusion sheath (DPS) is provided for cases where blood perfusion is needed for downstream arteries (distal) to the insertion point of the DPS within the target artery. The ability to provide distal perfusion with the DPS allows the DPS to be positioned in the target artery for long periods without causing lack of blood flow (ischemia) to an extremity that the target artery supplies. In embodiments, the DPS can still be used for surgical arterial access while allowing blood flow downstream.

Abstract: An apparatus is positioned in a hollow viscus organ and functions as a template for creating a lumen of a desired shape and size in the organ from the tissue of the organ. The apparatus is comprised of an elongate, flexible tube having opposite proximal and distal ends. The tube has several lumens or pathways that extend through the interior of the tube between the proximal and distal ends of the tube. A directional, steerable feature extends through one of the lumens of the tube. An anchor feature is provided at the tube distal end and is manually operable from the tube proximal end. An exterior surface dimension adjustable feature is provided adjacent the tube distal end.

Abstract: An implantable glaucoma drainage device (GDD) system is disclosed. The GDD system comprises a microflow control system for controlling intraocular pressure, a protective capillary carrier tube housing the microflow control system, and anchoring arms holding the implanted device in place. The overall GDD size can be in a needle-implantable form factor for minimally invasive implantation. The GDD may be implanted via subconjunctival needle implantation to mimic the normal aqueous humor drainage pathway.

Abstract: A method to remove ascites from a mammalian body including: draining ascites from the peritoneal cavity to the bladder of the mammalian body, and evacuating the drained ascites out of the bladder. The method may be practiced with a valved fistula implanted into the bladder to form a passage between the peritoneal cavity and the bladder.

Abstract: The present teachings provide a device and methods of making and use thereof. Specifically, one aspect of the present teachings provides a device for restricting blood flow entering the lung after each right bean systole. Certain embodiments of the present teachings provide a device that prevents a complete closure of the pulmonary valve leaflets so that a certain amount of blood is allowed to flow from the pulmonary artery to the right ventricle at the end of a right ventricle systole. Other embodiments of the present teachings provide a device that restricts the amount of blood outflowing from the right ventricle to the pulmonary artery. In addition, the present teachings also provide a delivery system for implanting such a device approximately to or at the pulmonary valve.