Pudenz-schulte Medical Research Corporation

Gary P East

Rudolf R Schulte

Alfons Heindl

David A Watson

Stephen W Laguette

Marga M Bryant

Leanne M Lintula

Alfons Heindle

Thomas J Carlisle

Robert H Pudenz

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 method for delivering a medication into a body cavity includes the steps of inflating a flexible bag within the body cavity such that the flexible bag expands to fill most of the void of the body cavity, and injecting medication into the space between an exterior surface of the flexible bag and the cavity wall such that the medication substantially surrounds the flexible bag and fills the remaining void. The steps of inflating the flexible bag and injecting medication are accomplished through subcutaneous injection at a site remote from the body cavity. To accomplish this, a surgically implantable tumor access device includes co-located first and second injection ports, for respectively, receiving a sterile fluid and a fluid medication. A flexible fluid conduit, which includes two coaxial tubes, directs the injected fluids, in a manner providing separate fluid flow paths, to a point adjacent to an inlet for the flexible bag. An inner tube fluidly connects the flexible bag with the first injection port. An outer tube surrounding the inner tube directs medication from the second injection port to medication delivery tubes fixed to an exterior surface of the flexible bag.

Tumor access device and method for delivering medication into a body

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 surgically implantable shunt system, including a flow control valve and an antechamber, is provided for controlling the release of entrapped body fluids. The flow control valve includes a pair of molded plastic bases situated, respectively, adjacent to an inlet and an outlet of the valve, which bases are situated within a flexible encasement. Each base includes an outer housing, a valve membrane carrier positioned within the housing, and a flow control member. The flow control members each include a central support and a resilient membrane which is generally arch-shaped and resiliently biased to contact the respective base generally along the outer edge of the membrane in a manner permitting only controlled one-way flow through the valve. The antechamber permits injection of medication into the shunt between a proximal catheter and the distally located flow control valve, and pumping of the medication in either direction.

Multiple-membrane flow control valve and implantable shunt system

A surgically implantable shunt system, including a flow control valve and an antechamber, is provided for controlling the release of entrapped body fluids. The flow control valve includes a pair of molded plastic bases situated, respectively, adjacent to an inlet and an outlet of the valve, which bases are situated within a flexible encasement. Each base includes an outer housing, a valve membrane carrier positioned within the housing, and a flow control member. The flow control members each include a rigid nail-like central support and a separate flexible resilient membrane positioned on the central support. A first flow control member is capable of selectively occluding the valve inlet, but is normally spaced from its base to permit free fluid flow through the inlet. The second flow control member is generally arch-shaped and resiliently biased to contact its respective base generally along the outer edge of the membrane in a manner permitting only controlled one-way flow through the valve. The antechamber permits injection of medication into the shunt between a proximal catheter and the distal flow control valve, and pumping of the medication in either direction. Additionally, a method for assembling the shunt system in a quick and economical manner is provided, which utilizes tapered grommets to anchor components in place prior to adhesively securing tubing to the flexible encasement.

Implantable shunt system and method of assembly

A totally subcutaneously implantable infusion reservoir and pump system 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. In a preferred form of the invention, 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. This control assembly includes a normally closed valve and a pump, 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. Moreover, the control assembly is constructed to prevent the backflow of fluid from the catheter to the reservoir, as well as the unrestricted flow of medication through the control assembly when the normally closed valve is opened. This is accomplished by requiring at least two deliberate and sequential applications of selective pressure to the control assembly before any medication stored in the reservoir can be transferred to the catheter.

Subcutaneous infusion reservoir and pump system

A subcutaneously implantable siphon control device is provided for use in a physiological shunt system including a proximal catheter, a flow control valve and a distal catheter. The siphon control device limits fluid flow through the shunt system due to the siphoning effect of hydrostatic pressure created by the elevation of the proximal catheter inlet with respect to the distal catheter outlet. The siphon control device includes, generally, a base having an inlet typically placed in fluid communication with an outlet of the flow control valve, and an outlet typically placed in fluid communication with the distal catheter, and a housing for the base which, in connection with the base, defines a fluid flow pathway between the inlet and the outlet. The base provides a wall having substantially parallel upper and lower seating surfaces, which separates the inlet from the outlet. A pair of spaced, substantially parallel, flexible and elastic diaphragms having inner and outer surfaces are provided by the housing, and are situated on opposite sides of the wall to position a portion of each inner surface in contact with an adjacent one of the seating surfaces.

Siphon control device

A surgically implantable flow control valve 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 valve includes a relatively rigid, unitized molded plastic base having a planar valve seat portion, an inlet passageway through the base which terminates at an inlet port situated within the planar valve seat portion of the base, a resilient membrane which is molded of a material different from the material of the plastic base and which is secured to the base in a manner surrounding and covering the inlet port, and an outlet separated from the inlet by the resilient membrane. Radiopaque indicators and markers are provided which permit a surgeon to ascertain specific information about the device and the functioning of the shunt system which would otherwise be unavailable without additional surgery.

Burr-hole flow control valve

A totally subcutaneously implantable infusion reservoir and pump system includes a variable capacity reservoir for receiving and storing fluids containing medications for delivery to a catheter which directs the medications to a specific infusion location in the body. A pump and a valving arrangement is interposed between the reservoir and the catheter to facilitate and control the transfer of the medications from the reservoir to the catheter in a safe and efficient manner. In one preferred form, a normally closed first valve is situated between the reservoir and a pump, and a normally closed second valve is situated between the pump and the catheter in a manner such that the pump and valving arrangement defines a portion of a fluid flow conduit between the reservoir and the catheter. The pump and valving arrangement requires at least two deliberate and sequential steps before the medications stored in the reservoir can be transferred to the catheter. As an additional safety feature, an integral flow occluder can be added to the pump and valving arrangement to prevent the emptying of the medications in the reservoir through the catheter into the body when both normally closed valves are opened simultaneously. When the system is used in the treatment of terminally ill patients, the catheter can be placed within the body to direct morphine or other pain killing medications directly into the lateral ventricle of the brain or into the lumbar subarachnoid space.

Infusion reservoir and pump system

A surgically implantable flow control valve is provided for use in shunt systems for controlling the release of entrapped body fluids. The valve includes a relatively rigid, unitized molded plastic base separating an inlet chamber from an outlet chamber and including one or more apertures passing from the inlet chamber to the outlet chamber, and a resilient membrane which is molded of a material different from the material of the plastic base and which is secured to the base in a manner covering the apertures through the base on the outlet chamber side of the base. Fluid flow occluders on the base facilitate both proximal and distal flushing, and radiopaque indicators and markers permit a surgeon to ascertain specific information about the device and the functioning of the shunt system which would otherwise be unavailable without additional surgery.

Flow control valve

For use in controlling the release of entrapped body fluids, a surgically implantable flow control valve is provided which includes a molded plastic base separating an inlet chamber from an outlet chamber and including one or more apertures passing from the inlet chamber to the outlet chamber, and a resilient membrane which is molded of a material different from the material of the plastic base and which is secured to the base covering the aperture or apertures through the base on the outlet chamber side of the base.

Growing community of inventors

Santa Barbara, CA, United States of America

Gary P East