Single monolithic piece pivc-integrated hemolysis-reduction accessories for direct blood draw

A method of manufacturing a single monolithic piece flow restriction device configured to limit hemolysis during the drawing of blood from a patient, the method comprising:

• providing first and second mold parts, each of the first and second mold parts comprising an imprint recessed therein, the imprint comprising a male luer connector imprint portion at a distal end portion of the first mold part, a female luer connector imprint portion at a proximal end portion thereof, a micro-channel imprint portion extending longitudinally between the male luer connector imprint portion and the female luer connector imprint portion, and a reinforcing rib imprint portion surrounding the micro-channel imprint portion;
• inserting a male luer connector mold part into the male luer connector imprint portion;
• inserting a female luer connector mold part into the female luer connector imprint portion, the female luer connector mold part comprising a micro-channel mold part extending from a distal end of the female luer connector mold part, wherein the micro-channel mold part is inserted into the micro-channel imprint portion;
• coupling the first and second mold parts to form a mold assembly;
• injecting a molten mold material into the mold assembly;
• and
• cooling the mold assembly.

A flow restriction device, comprising:

• first and second connector halves fused together to form a single connector, the single connector comprising:
• a male luer connector portion configured to couple to a catheter assembly, the male luer connector portion comprising an internal surface defining a lumen thereof;
• a female luer connector portion disposed proximally to the male luer connector portion and configured to couple to a fluid collection device, the female luer connector portion comprising an internal surface defining a lumen fluidly connected to the lumen of the male luer connector portion;
• and
• a body portion extending between the male luer portion and the female luer portion, and integrally formed with the male luer portion and the female luer portion to form a single monolithic piece, the body portion comprising at least one recess extending longitudinally therethrough and fluidly communicated with the lumens of the male luer portion and the female luer portion, wherein the at least one recess defines a micro-channel along which a fluid flows from the male luer connector portion into the fluid collection device via the female luer connector portion.

A peripheral intravenous catheter assembly configured to limit hemolysis during the drawing of blood from a patient, comprising:

• a flow restriction device, comprising,
• a male luer connector portion configured to couple to a catheter assembly, the male luer connector portion comprising an internal surface defining a lumen thereof;
• a female luer connector portion disposed proximally to the male luer connector portion and configured to couple to a fluid collection device, the female luer connector portion comprising an internal surface defining a lumen fluidly connected to the lumen of the male luer connector portion;
• and
• a body portion extending between the male luer portion and the female luer portion, and integrally formed with the male luer portion and the female luer portion to form a single monolithic piece, the body portion comprising a recess extending longitudinally therethrough and fluidly communicated with the lumens of the male luer portion and the female luer portion, wherein the recess defines a micro-channel, the micro-channel configured to limit hemolysis of blood as the blood is drawn from a patient from the male luer connector portion into the fluid collection device via the female luer connector portion;
• a catheter hub having a proximal end and a distal end;
• and
• a fluid connector that fluidly couples the catheter hub with the flow restriction device.