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

A fluid flow control device for use in a subcutaneously implantable physiological shunt system, comprising:

• a rigid proximal base having a first passageway for fluids entering the fluid flow control device, and a second passageway for fluid exiting the proximal base;
• a rigid distal base having a third passageway for receiving fluids exiting the proximal base through the second passageway, and a fourth passageway for fluids exiting the fluid flow control device;
• means for connecting, without the use of adhesives, the proximal base to the distal base, the connecting means including a snap-fit barbed connector defining the second passageway, and a complementary connector receptacle defining the third passageway, such that insertion of the connector into the receptacle interlocks the proximal base and the distal base and prevents dissociation of the proximal and distal bases after the connector is inserted into the receptacle;
• a flexible housing generally surrounding the proximal and distal bases to define, in connection with the bases, a fluid flow path through the fluid flow control device, wherein the housing and the distal base cooperate to provide means for flushing fluid through the fluid flow control device by application of percutaneous manual pressure to the device, and wherein the housing and the distal base cooperate to provide a siphon controlled device which prevents fluid flow through the fluid flow control device in the absence of positive upstream fluid pressure through the device or in response to negative hydrostatic downstream pressure on the device;
• and
• a valve situated between the flushing means and the siphon control device.

A process for manufacturing an implantable fluid flow control device having a two-piece base, the process steps comprising:

• providing a first base having first and second fluid passageways therethrough, and a first locking member, wherein the first locking member defines the second fluid passageway;
• providing a second base having third and fourth fluid passageways therethrough, and a second locking member, wherein the second locking member defines the third fluid passageway;
• inserting the first locking member into the second locking member to fluidly couple the second and third fluid passageways and to mechanically attach the first base to the second base in a manner limiting tensile movement between the bases;
• spot welding the first and second bases to fuse the first and second locking members together;
• and
• assembling the first and second bases within a flexible housing such that the bases and the housing cooperatively define a fluid flow path through the flow control device.

A process for manufacturing an implantable fluid flow control device having a two-piece base, the process steps comprising:

• providing a first base having first and second fluid passageways therethrough, a snap-fit barbed connector which defines the second fluid passageway, and a spline offset from the barbed connector and extending generally parallel thereto;
• providing a second base having third and fourth fluid passageways therethrough, a connector receptacle defining the third fluid passageway, and a spline receiving slot;
• inserting the connector into the receptacle to interlock the first base and the second base and prevent disassociation of the bases after the connector is inserted into the receptacle, wherein simultaneously the spline is slidably received within and substantially enveloped by the spline receiving slot in a manner limiting torsional movement between the bases;
• spot welding the first and second bases, including the steps of placing the coupled bases in a holding fixture, bringing a heated element into close proximity with the spline, and melting the spline into the spline receiving slot such that the first and second bases are fused together;
• and
• assembling the first and second bases within a housing such that the bases and the housing cooperatively define a fluid flow path through the flow control device extending from the first fluid passageway forming an inlet of the fluid flow control device, to the fourth fluid passageway forming an outlet for the fluid flow control device, wherein the housing and the first base cooperate to provide means for flushing fluid through the fluid flow control device by application of percutaneous manual pressure to the flow control device, and wherein the housing and the second base cooperate to provide a siphon control device which prevents fluid flow through the fluid flow control device in the absence of positive upstream fluid pressure through the flow control device or in response to negative hydrostatic downstream pressure on the flow control device, and wherein a valve is situated between the flushing means and the siphon control device within the fluid flow path.