Pudenz-schulte Medical Research Corporation

Medtronic, Inc.

Mentor Corporation

David A Watson

Gary P East

Lori Cone Speckman

Mark J Licata

Paul S Vaskelis

William Jeffrey Bertrand

Alfons Heindl

Edward C Leicht

Stephen W Laguette

Dennis E Condon

Michele R Jensen

Thomas J Carlisle

A surgically implantable flow control device positionable over a burr-hole through a patient's skull is provided for use in shunt systems for controlling the release of entrapped body fluids. The device includes a rigid base including an inlet port and a valve seat which surrounds the inlet port, and a flow control member secured to the base. The flow control member has an asymmetric membrane which is resiliently biased to contact the valve seat in a manner forming a releasible seal therebetween, to provide controlled resistance to proximal-to-distal fluid flow through the device. The membrane includes a septum portion overlying the inlet port and a relatively thin portion responsive to fluid pressure differentials on inlet and outlet sides thereof. A membrane shield overlies an outlet side of the membrane and includes a needle guide aperture in alignment with the septum portion of the membrane and the inlet port.

Burr-hole flow control device

A subcutaneously implantable vascular access port includes a base which defines a plurality of fluid cavities separated by a dividing wall configured to provide an outlet duct for each fluid cavity, wherein the outlet ducts are staggered along the length of the dividing wall, a cap configured to receive the base and which includes a plurality of septum access apertures aligned with the fluid cavities, and a single self-sealing septum captured between the cap and the base. An outlet stem exits the base and communicates with the fluid cavities therein. The outlet stem has two prongs formed in a side-by-side configuration extending outwardly from the base. Fluid injected into a fluid cavity through the septum flows through a smooth transition region in which the cross-sectional area is smoothly reduced from the corresponding fluid cavity. A locking sleeve provides radial inward pressure upon the catheter which is slid over the outlet stem, thereby insuring that the catheter remains mounted on the outlet stem.

Dual-reservoir vascular access port

A partially disposable instrument for use in a medical procedure includes a rigid introducer assembly and a fiber-optic endoscope having a flexible shaft which may be removably inserted through the introducer assembly. The introducer assembly permits a fluid to be flushed therethrough and about the shaft such that the fluid exits through a terminal end of the introducer assembly. The instrument may be utilized in connection with a method for positioning a catheter within a body during a medical procedure, including the steps of placing the catheter over the introducer, inserting the shaft of the endoscope through the introducer, advancing the catheter, introducer and endoscope shaft into the body as a unit, positioning the catheter within the body utilizing the fiber-optic endoscope, and removing the endoscope shaft and the introducer from the body while leaving the catheter in place. The catheter includes a slit tip capable of opening to permit the terminal end of the introducer assembly to pass therethrough such that the diameter of the slit tip, when so configured, is not significantly greater than a nominal diameter of the catheter.

Slit tip ventricular catheter and method of manufacturing same

A subcutaneously implantable and percutaneously adjustable fluid flow control device includes a magnetically adjustable valve for controlling fluid flow from an inlet to an outlet. The valve includes a housing having a fluid passageway therethrough, a valve element designed to bear upon a valve seat to close the passageway to fluid flow, and a spring which biases the valve element against the valve seat so as to keep the passageway closed until a fluid pressure differential between the inlet and the outlet exceeds a selected valve opening pressure. A fixed dual concentric stair-step array and an overlying rotor assembly permit the amount of bias applied to the valve element by the spring to be adjusted. The rotor assembly is adapted to rotate in response to an external or percutaneously-applied magnetic field. In one embodiment, the rotor assembly may be locked into one of several possible rotational positions relative to the stair-step array to prevent rotation thereof.

Implantable adjustable fluid flow control valve

In a cerebrospinal fluid shunt including a flow control device forming a portion of a fluid conduit, a capacitive element is provided for reducing overdrainage of cerebrospinal fluid due to the pulsatile nature of cerebrospinal fluid flow. The capacitive element includes a reservoir having a base and a housing for the base which cooperatively define a fluid flow pathway through the reservoir. A pair of spaced, substantially parallel, flexible diaphragms form opposite sides of the housing such that each flexible diaphragm has an outer surface which forms an exterior surface of the reservoir, and an inner surface in contact with and subject to pressure variations of cerebrospinal fluid within the reservoir. A raised ring surrounds each diaphragm and forms a recess in which the respective diaphragm is positioned. The capacitive element accommodates the pulsatile nature of cerebrospinal fluid flow between a cerebrospinal fluid source and the flow control valve by varying the fluid capacity of the reservoir.

Pulsatile flow-accommodating fluid shunt

An implantable shunt device useful in treating glaucoma includes an episcleral plate and a catheter having a first end adapted for insertion into the anterior chamber of the eye, and a second end mounted adjacent to the episcleral plate. A slit valve is provided in a wall of the catheter between the first end and the second end, and the opposing, generally planar surfaces of the episcleral plate are textured to interrupt the formation of a dense fibrous capsule and to promote vascularization around the episcleral plate. In order to restrict the flow of fluid through the catheter to the episcleral plate until a fibrous capsule forms around the episcleral plate, the catheter is temporarily occluded utilizing a biodegradable ligation tied between the slit valve and the second end of the catheter. In the immediate post-operative period, excess aqueous humor is forced to flow through the slit valve, which provides a significant pressure drop. Once the ligature is resorbed, aqueous humor is free to flow through the catheter to the episcleral plate for resorption into the vascular system.

Glaucoma shunt and method for draining aqueous humor

An implantable fluid flow control device is assembled in a process wherein a first base is provided having a snap-fit barbed connector which defines a fluid passageway and a spline offset from the barbed connector, and a second base having a connector receptacle which defines another passageway and a spline receiving slot. The barbed connector is inserted into the receptacle, and simultaneously the spline is slidably received within the spline receiving slot in a manner preventing tensile and torsional movement between the bases. The coupled bases are placed in a holding fixture, and brought into close proximity with a heated element to fuse the first and second bases together. A pair of housing bodies are placed over, respectively, the first and second bases such that the bases and the housing bodies cooperatively define a fluid flow path through the flow control device. In particular, the housing and the first base cooperate to provide a reservoir for flushing fluid through the device by application of percutaneous manual pressure to the device, and the housing and the second base cooperate to provide a siphon control device. A valve is situated between the flushing reservoir and the siphon control device within the fluid flow path to control passage of fluid through the device.

Implantable fluid flow control device having two-piece base, and

A flow control device for use in a subcutaneously implanted physiological shunt system includes a relatively rigid base and a resiliently flexible encasement which defines a fluid flow path therethrough from an inlet to an outlet. Two valves for controlling the flow of fluid through the device are situated within the fluid flow path between the inlet and the outlet. The fluid flow path includes a first fluid conduit which directs fluid through both valves, and a second fluid conduit which bypasses the first valve and directs fluid only through the second valve. The first valve is constructed to provide a greater resistance to flow through the device than the second valve, and when the second fluid conduit is unobstructed, fluid will tend to flow through the second fluid conduit and bypass the first valve. A pivotable plug is provided within the encasement for selectively occluding a portion of the second fluid conduit. The position of the plug is determined by a magnetically polarized, percutaneously manipulable cam also provided within the encasement. The plug and the cam are attached such that rotation of the cam in one direction causes the plug to occlude the second fluid conduit, and rotation of the cam in another direction opens the second fluid conduit to fluid flow. A siphon control device is provided adjacent to the outlet to prevent fluid flow in response to negative downstream hydrostatic pressure on the outlet of the device.

Flow control device having selectable alternative fluid pathways

A flow control device for use in a subcutaneously implanted physiological shunt system includes a relatively rigid base and a resiliently flexible encasement which defines a fluid flow path therethrough from an inlet to an outlet. Two valves for controlling the flow of fluid through the device are situated serially within the fluid flow path between the inlet and the outlet. The fluid flow path includes a first fluid conduit which directs fluid through both valves, and a second fluid conduit which bypasses the first valve and directs fluid only through the second valve. The first valve is constructed to provide a greater resistance to flow through the device than the second valve, and when the second fluid conduit is unobstructed, fluid will tend to flow through the second fluid conduit and bypass the first valve. A plug is integrally formed with a portion of the encasement, for occluding the second fluid conduit. The plug can be inserted into a receiving collar to occlude the second fluid conduit, by manual percutaneous pressure, thereby requiring all fluid flow through the device to pass through the first fluid conduit. A siphen control device is provided between the valves and the outlet to prevent fluid flow in the absence of positive upstream fluid pressure or in response to negative downstream hydrostatic pressure on the outlet of the device.

A subcutaneously implantable medication infusion device includes a variable capacity reservoir for receiving and storing fluid medication for delivery to a catheter which directs the medication to a specific infusion location in the body. A control assembly is interposed between the reservoir and the catheter to facilitate and control the transfer of the medication from the reservoir to the catheter in a safe and efficient manner. The control assembly includes a self-recharging pump and a normally closed valve, both of which are manually actuable by percutaneous pressure when subcutaneously implanted, and defines a portion of a fluid flow conduit between the reservoir and the catheter. The control assembly is constructed to permit the infusion of a measured bolus of medication on demand through manual percutaneous manipulation of the control assembly. A restrictor is provided the control assembly to limit the rate the pump is recharged with medication, to restrict the total amount of medication which can be pumped into the catheter over a given period of time. In one preferred form, the pump recharge restriction is created by providing at least one capillary-like fluid pathway through which the recharge fluid must pass before entering the pump. In another preferred form of the invention, the recharge flow rate of medication into the pump is restricted by a wick restrictor.

Medication infusion device with dose recharge restriction

A subcutaneously implantable injection port includes an elastomeric outer housing which encloses an easily assemblage multi-piece rigid base structure. An injection chamber is defined between an upper septum, formed integrally with the elastomeric outer housing, and the underlying base structure. The outer housing includes an upper dome and a lower reinforced sheet. The septum, which is formed integrally with the upper dome, includes a septum flange which is compressed, interiorly of the outer housing, between two base members. A filter extends across the injection chamber dividing it into upper and lower portions. A needle guard, provided by one of the base components, prevents contact between a needle inserted into the injection chamber and the filter. An outlet connector integrally formed with one of the base components extends through the outer housing for connecting a catheter or the like, with the lower portion of the injection chamber. In assembling the injection port, a first base member or rigid outer ring is placed adjacent to an interior surface of the elastomeric outer housing. A filter is placed within a second base member and held securely in place thereon by a third base member which provides the needle guard and fits within the second base member in an interference fit. This assembly is pushed into the first base member in a manner compressing the septum flange and creating a fluid-tight injection chamber.

Injection port

A stylet assembly is provided for inserting a catheter into a brain ventricle and providing a cerebrospinal fluid flashback indicia of proper catheter positioning. The stylet assembly includes an elongated, generally cylindrical rigid hollow stylet having an open distal end, a rounded blunt proximal end, and an internal fluid passageway extending the length of the stylet. A relatively large single aperture is provided through the stylet adjacent to its proximal end, for permitting fluid flow into the internal fluid passageway. The aperture is configured to underlie a plurality of catheter inlet apertures and has a width generally corresponding with the diameter of the internal fluid passageway. An elastomeric hub surrounds a portion of the stylet adjacent to the distal end. The hub is configured to permit the flow of cerebrospinal fluid through the open distal end, and allows the open distal end of the stylet to be selectively manually occluded with a finger to prevent the flow of cerebrospinal fluid therethrough.

Closed end hollow stylet assembly

A subcutaneously implantable medication infusion device includes a variable capacity reservoir for receiving and storing fluid medication for delivery to a catheter which directs the medication to a specific infusion location in the body. A control assembly is interposed between the reservoir and the catheter to facilitate and control the transfer of the medication from the reservoir to the catheter in a safe and efficient manner. The control assembly includes a self-recharging pump and a normally closed valve, both of which are manually actuable by percutaneous pressure when subcutaneously implanted, and a one-way valve positioned within a primary fluid conduit between the pump and the normally closed valve. The control assembly is constructed to permit the infusion of a measured bolus of medication on demand through manual percutaneous manipulation of the control assembly. A capillary-like fluid pathway through which the recharge fluid must pass before entering the pump, is provided to limit the rate the pump is recharged with medication, and to restrict the total amount of medication which can be pumped into the catheter over a given period of time. An alternate fluid conduit extends between the pump and the normally closed valve, and a Porex-type plug situated within the alternate fluid conduit prevents the flow of liquid medication therethrough under normal use conditions, but permits the passage of gasses through the alternate fluid conduit to facilitate steam autoclave sterilization of the pumping chamber.

Sterilizable medication infusion device with dose recharge restriction

A tissue expanding device includes a substantially non-extensible base and a top layer joined to the periphery of the base such that the base and the expansion layer are in contact with each other when the device is in a non-expanded state. In the non-expanded state, the device has a thickness substantially equal to the thickness of the combined thickness of the base and expansion layer.

Growing community of inventors

Goleta, CA, United States of America

David A Watson