Dialysis Catheters with Fluoropolymer Additives

Abstract

A venous access catheter shaft and method of using and manufacturing such a catheter is provided. In one aspect of the invention, a catheter is provided comprising a base polymer having a Shore A durometer of 85A or lower, with 2.0% percent by weight of surface modifier, and a radiopaque filler comprising between 20-40 percentage by weight. In another aspect of the invention, a method reducing thrombus accumulation on a venous access catheter is provided wherein the catheter surface's resistance to thrombus formation is enhanced during indwell time by lowering the durometer rating of the base polymer of the catheter without increasing the amount of surface modifier additive. In another aspect of the invention, a method of manufacturing a catheter shaft is provided, wherein the shaft is formed comprising a base polymer having a Shore A durometer of 85A or lower, with 2.0% percent by weight of surface modifier, and a radiopaque filler comprising 30% by weight barium sulfate, and optionally a colorant of 0.2% weight.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Patent Application Ser. No. 61 / 791,863 filed Mar. 15, 2013, entitled “Catheter Shaft with Enhanced Platelet Anti-Adhesion Surfaces.”FIELD OF THE INVENTION[0002]The present invention relates to a medical device apparatus and method for using and manufacture of such. More particularly, the present invention relates to indwelling venous access catheter devices comprising a shaft having a fluoropolymer additive and a polymer base within a specific durometer range.BACKGROUND OF THE INVENTION[0003]Venous access catheters provide venous access to the central circulatory system. Venous access catheters include central venous catheters, midlines dialysis catheters, implantable ports and peripherally inserted central catheters, also known as PICC lines. The access line or port with attached catheter is used for the delivery of intravenous fluids, medications such as chemotherapy drugs and antibio...

AI Technical Summary

Benefits of technology

[0014]According to the principles of the present invention, a venous access catheter shaft and method of using and manufacturing such a catheter is provided. In one aspect of the invention, a catheter is provided comprising a base polymer having a Shore A durometer of 85A or lower, with 2.0% percent by weight of surface modifier, and a radiopaque filler comprising between 20-40 percentage by weight. In another aspect of the invention, a method reducing thrombus accumulation on a venous access catheter is provided wherein the catheter surface's resistance to thrombus formation is enhanced during indwell time by lowering the durometer rating of the base polymer of the catheter without increasing the amount of surface modifier additive. In another aspect of the invention, a method of manufacturing a catheter shaft is provided, wherein the shaft is formed comprising a base polymer having a Shore A durometer of 85A or lower, with 2.0% percent by weight of surface modifier, and a radiopaque filler comprising 30% by weight barium sulfate, and optionally a colorant of 0.2% weight.Experimental Results

Problems solved by technology

One of the most common complications resulting from long term implantation of venous access devices is the buildup of thrombus on the indwelling portion of the catheter due to blood platelet adhesion on the catheter shaft surfaces.

Localized thrombus buildup on the catheter can result in various complications which compromise the performance of the indwelling device including increased catheter related blood stream infection, complete or partial catheter occlusion and non-laminar blood flow.

For example, attempts to prevent or minimize thrombus formation on catheter surfaces have focused on catheter coatings including anticoagulants, such as heparin The main disadvantage of coatings is the tendency of the coating to elude from the shaft after implantation resulting in reduced long-term protection against thrombus formation.

However, the subsequent step differs in that a chain extension is not carried out.

The control PICC catheter, on the other hand, showed extensive thrombus accumulation.

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