Pudenz-schulte Medical Research Corporation

Pudenz-schulte Med, Research Corp.

Alfons Heindl

Gary P East

Rudolf R Schulte

Marga M Bryant

Leanne M Lintula

Stephen W Laguette

David A Watson

Edward C Leicht

Mark J Licata

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 ventriculostomy reservoir includes a rigid base and an elastomeric cap which is positioned over the base to enclose a reservoir well. A rigid cap insert is captured by the lower portion of the cap and is positioned for engagement with the base. The cap insert and the base are configured so that the cap may be snap-fit onto the base in a manner forming a fluid-tight seal therebetween. In one form of the invention, the cap insert includes a cylindrical portion which extends downwardly from a flange-like portion captured within the cap, to fit within an upwardly extending wall portion of the base. The cylindrical portion includes an encircling protrusion on an exterior surface thereof which engages and fits within an encircling detent provided on the interior surface of the wall portion to snap-fit the cap to the base. In a second embodiment of the invention the cap insert exteriorly surrounds an upper end of the base, and a similar protrusion and detent arrangement is utilized to snap-fit the cap to the base. In a third embodiment of the invention the cap insert overlies an upper end of the base and is secured to the base through an interference fit both on interior and exterior surfaces of the wall portion of the base.

Ventriculostomy reservoir

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 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 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

Goleta, CA, United States of America

Alfons Heindl