Early technology for vascular access required surgical opening of the skin, viewing of the vessel to be catheterized, and placement, under sterile procedure of a stainless steel needle. After the insertion process, the skin was approximated and the access site covered to prevent infection. The process required a competent physician, and was indicated only in rare instances when the patient required intravascular sustenance or required replacement fluids in association with major surgery.
With many of the described catheterization technologies, blood contamination was a risk when the intra-vascular catheter was inserted. Blood flashback often escaped the catheter hub when the guide needle was removed and before the intra-vascular solution tubing could be connected, thus exposing the caregiver and patient to blood leakage. Several notable valve designs have been patented to reduce this blood leakage. For example, in U.S. Pat. No. 4,387,879, Tauschinski describes a self-sealing elastomeric disc that can be incorporated into a connector body to interface with a parenteral supply solution and an intra-vascular catheter. Similarly, Motisi et al, describe a one way valve in the body of a catheter apparatus in U.S. Pat. No. 5,843,046. However, the necessity of a plunger and introduction of needle or tubing through the plunger decreases the inside diameter of the catheter and reduces the fluid flow rates for this design. An “O” ring in the valve can prevent leakage from around the plunger, but this decreases the inside diameter of the large bore catheter. The valve is held in place by a “cap” which puts its placement deeper into the throughbore, out of reach of conventional intra-vascular tubing or conventional syringes. The “cap” also prevents connection to conventional tubing or conventional syringes. This valve is bulky and decreases the size of the intra-vascular catheter. It also cannot be opened by insertion of conventional devices used by those skilled in the art.
I-V Access Technology, Inc. (IVAT) has intellectual property for a peripheral IV catheter that incorporates an automatic needle retraction mechanism (U.S. Pat. Nos. 8,105,288 and 8,591,469) to retract or withdraw the guide needle when the vein is accessed, a dilator to expand the lumen created by the guide needle (also in US patent divisional application Quine docket 138-000112US), and a pressure activated fluid flow control valve (US patent application US-2013-0204226-A1) to prevent blood leakage when the needle or needle/dilator assembly is fully withdrawn from the catheter assembly. The valve is opened and IV therapy administered through the catheter and into the vasculature when a male luer fitting is inserted into the proximal opening of the catheter hub and contacts the proximal side of the valve.
Although the specific design of the male luer fitting is standardized by ISO, in practice the manufacturers of IV fittings, luer connectors, and syringes produce their products with the male luer geometry sometimes deviating significantly from the ISO standard. As a result, the degree to which the male luer fitting contacts the proximal side of IVAT' s valve can vary functionally from an inability to open the valve (no contact at all) to damaging the valve from a shearing of the valve against the catheter hub distal to the valve.
Other manufacturers who produce IV catheters with integrated valves have incorporated a separate slidable adapter piece within the catheter hub that, as the male luer is inserted, it contacts the adapter piece which is axially displaced and penetrates the slits in the valve, thereby opening the fluid flow pathway. The adapter piece that penetrates the slits is generally conical in shape, which allows the adapter to readily open the valve without excessive force, and, when the male luer is removed (e.g. when medication injection through a syringe is completed) the valve exerts an elastic force on the adapter to axially displace the adapter and close the valve to fluid flow. The adapter piece, while considered a necessity to accommodate various male luer geometries and dimensional variations, adds cost and complexity to the manufacturing of the IV catheter. The extra component requires extra material, tooling, and labor costs to produce and potentially additional costs for assembly.
In light of the problems remaining in the art, it would be beneficial to have catheter devices well adapted to receive both standard and non-standard male luer fittings. It would be desirable to have sanitary catheter fittings that seal with non-standard male luers while allowing automatic opening of valves facilitating withdrawal or injection of fluids. Simplified methods and component configurations are needed to allow ready assembly of catheter devices containing a variety of elements finely crafted from a variety of materials. The present invention provides these and other features that will be apparent upon review of the following.