Blood collection adapter and related devices to reduce hemolysis

1 . An adapter, comprising:

a distal end, comprising a distal connector configured to couple to a catheter assembly;

a proximal end, comprising a proximal connector configured to couple to a blood collection device;

a middle portion disposed between the distal end and the proximal end and joining the distal connector to the proximal connector, the middle portion being integrally formed with the distal connector and the proximal connector to provide a singular, unitary adapter body, with a lumen extending through the distal end, the middle portion, and the proximal end; and

a tube positioned within the lumen, in the middle portion, the tube defining a fluid pathway disposed between the distal end and the proximal end, wherein the fluid pathway includes a non-linear portion;

wherein each of the proximal connector and the distal connector comprises a luer connector integrally formed with the middle portion, with the distal luer connector extending out distally from the middle portion to form the distal end and the proximal luer connector extending out proximally from the middle portion to form the proximal end; and

wherein the fluid pathway comprises a geometric factor, G f , configured to reduce hemolysis in blood flowing proximally through the adapter to the blood collection device.

2 . The adapter of claim 1 , wherein the non-linear portion forms a coil shape.

3 . The adapter of claim 1 , wherein the non-linear portion forms an S-shape.

4 . The adapter of claim 1 , wherein the distal connector comprises a male luer threaded connector including a collar positioned about a male extension member.

5 . The adapter of claim 1 , wherein the distal connector comprises a male luer slip connector including a male extension member.

6 . The adapter of claim 1 , wherein the distal connector further comprises a blunt cannula extending out distally from the luer connector at the distal end.

7 . The adapter of claim 1 , wherein the proximal connector comprises a female luer connector including a cavity configured to receive a male luer connector.

8 . The blood collection set of claim 1 , wherein the geometric factor, G f , is defined as:

G

f

=

L

/

D

4

where L is a length of the fluid pathway and D is a diameter of the fluid pathway.

9 . The blood collection set of claim 8 , wherein the geometric factor, G f , is one of:

3.83E+06 (1/in 3 ) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent;

3.27E+06 (1/in 3 ) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent;

3.33E+06 (1/in 3 ) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent; or

1.50E+07 (1/in 3 ) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent.

10 . A blood collection set, comprising:

a blood collection device; and

an adapter, comprising:

a distal end, comprising a distal connector configured to couple to a catheter assembly;

a proximal end, comprising a proximal connector coupled to the blood collection device;

a middle portion disposed between the distal end and the proximal end and joining the distal connector to the proximal connector, the middle portion being integrally formed with the distal connector and the proximal connector to provide a singular, unitary adapter body, with a lumen extending through the distal end, the middle portion, and the proximal end; and

a tube positioned within the lumen, in the middle portion, the tube defining a fluid pathway disposed between the distal end and the proximal end, wherein the fluid pathway includes a non-linear portion;

wherein each of the proximal connector and the distal connector comprises a luer connector integrally formed with the middle portion, with the distal luer connector extending out distally from the middle portion to form the distal end and the proximal luer connector extending out proximally from the middle portion to form the proximal end; and

wherein the tube and the fluid pathway defined thereby is configured to reduce hemolysis in blood flowing proximally through the adapter to the blood collection device.

11 . The blood collection set of claim 10 , wherein the blood collection device comprises a syringe.

12 . The blood collection set of claim 10 , wherein the blood collection device comprises a needle configured to pierce a seal of an evacuated blood collection tube.

13 . The blood collection set of claim 12 , wherein the blood collection device further comprises a cylindrical holder extending around the needle.

14 . The blood collection set of claim 10 , wherein the non-linear portion forms a coil shape.

15 . The blood collection set of claim 10 , wherein the non-linear portion forms an S-shape.

16 . The blood collection set of claim 10 , wherein the distal connector comprises one of a male luer threaded connector, a male luer slip connector, and a blunt cannula.

17 . The blood collection set of claim 10 , wherein the proximal connector comprises a female luer connector.

18 . The blood collection set of claim 10 , wherein the fluid pathway comprises a geometric factor, Gr, configured to reduce hemolysis in blood flowing through the adapter to the blood collection device, the geometric factor defined as:

G

f

=

L

/

D

4

where L is a length of the fluid pathway and D is a diameter of the fluid pathway.

19 . The blood collection set of claim 18 , wherein the geometric factor, G f , is one of:

3.83E+06 (1/in 3 ) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent;

3.27E+06 (1/in 3 ) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent;

3.33E+06 (1/in 3 ) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent; or

1.50E+07 (1/in 3 ) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent.

20 . A method for collecting a blood sample comprising:

providing an adapter, comprising:

a distal end, comprising a distal connector configured to couple to a catheter assembly;

a proximal end, comprising a proximal connector;

a middle portion disposed between the distal end and the proximal end and joining the distal connector to the proximal connector, the middle portion being integrally formed with the distal connector and the proximal connector to provide a singular, unitary adapter body, with a lumen extending through the distal end, the middle portion, and the proximal end; and

a tube positioned within the lumen, in the middle portion, the tube defining a fluid pathway disposed between the distal end and the proximal end, wherein the fluid pathway includes a non-linear portion;

wherein each of the proximal connector and the distal connector comprises a luer connector integrally formed with the middle portion, with the distal luer connector extending out distally from the middle portion to form the distal end and the proximal luer connector extending out proximally from the middle portion to form the proximal end;

coupling the distal connector to the catheter assembly to place the catheter assembly in fluid communication with the adapter;

coupling the proximal connector to a blood collection device to place the blood collection device in fluid communication with the adapter; and

collecting a blood sample in the blood collection device, to enable further testing of the blood sample, with the blood sample flowing through the catheter assembly and the adapter and into the blood collection device, with blood flowing through an entirety of the non-linear portion as the blood travels through the adapter.