VENOUS ACCESS DEVICE

• US 20160000363A1
• Filed: 07/02/2015
• Published: 01/07/2016
• Est. Priority Date: 07/02/2014
• Status: Active Grant

• Current Assignee: Site Saver, Inc.
• Original Assignee: Bad Technologies LLC
• Inventors: Jones, Spencer A., DePoyster, David R., Nichols, David L., Richardson, Christopher M., Shada, Kelli L.
• Granted Patent: US 11,445,954 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes

Abstract

A venous access device includes a hub and a bifurcated cannula. The hub includes a bifurcated connecting arm, a blood sampling arm connected to the bifurcated connecting arm, a fluid transfer arm connected to the bifurcated connecting arm, a blood sampling channel and a fluid transfer channel. The blood sampling channel passes through the blood sampling arm and the bifurcated connecting arm. The fluid transfer channel passes through the fluid transfer arm and the bifurcated connecting arm. The bifurcated cannula is coupled to the bifurcated connecting arm and includes a blood sampling lumen having a blood sampling port, a fluid transfer lumen having a fluid transfer port, and a dividing member separating the blood sampling lumen from the fluid transfer lumen. The blood sampling port is 2 mm to 20 mm proximal from the fluid transfer port. The blood sampling channel is fluidly connected to the blood sampling lumen, and the fluid transfer channel is fluidly connected to the fluid transfer lumen.

Claims

1. A venous access device, comprising:

(a) a hub, comprising,

(i) a bifurcated connecting arm,

(ii) a blood sampling arm, connected to the bifurcated connecting arm,

(iii) a fluid transfer arm, connected to the bifurcated connecting arm,

(iv) a blood sampling channel, passing through the blood sampling arm and the bifurcated connecting arm, and

(v) a fluid transfer channel, passing through the fluid transfer arm and the bifurcated connecting arm, and

(b) a bifurcated cannula, coupled to the bifurcated connecting arm, comprising,

(i) a blood sampling lumen, having a blood sampling port,

(ii) a fluid transfer lumen, having a fluid transfer port, and

(iii) a dividing member, separating the blood sampling lumen from the fluid transfer lumen,

wherein the blood sampling port is 2 mm to 20 mm proximal from the fluid transfer port,

the blood sampling channel is fluidly connected to the blood sampling lumen, and

the fluid transfer channel is fluidly connected to the fluid transfer lumen.

2. The venous access device of claim 1, further comprising a fitting coupled to the blood sampling arm.

3. The venous access device of claim 1, further comprising a fitting coupled to the fluid transfer arm.

4. The venous access device of claim 1, wherein the bifurcated cannula is a 17, 18 or 19 gauge cannula.

5. The venous access device of claim 1, wherein the bifurcated cannula is a 20, 21, 22, 23 or 24 gauge cannula.

6. The venous access device of claim 1, wherein the hub is monolithic.

7. The venous access device of claim 1, wherein the hub comprises a material selected from the group consisting of polypropylenes, polyethylenes, polycarbonates and polyamides.

8. The venous access device of claim 1, wherein the bifurcated cannula comprises a material selected from the group consisting of polyurethanes, polyamides, polyether block amides (PEBA), polytetrafluoroethylenes (PTFE) and BD VIALON®

biomaterial.

9. The venous access device of claim 1, wherein the blood sampling port is 5 mm to 16 mm proximal from the fluid transfer port.

10. The venous access device of claim 1, wherein the blood sampling port is 8 mm to 12 mm proximal from the fluid transfer port.

11. The venous access device of claim 1, wherein the venous access device is sterile.

12. The venous access device of claim 1, wherein the hub is monolithic, the blood sampling port is 5 mm to 16 mm proximal from the fluid transfer port, and

the venous access device is sterile.

13. The venous access device of claim 1, further comprising a first fitting coupled to the blood sampling arm, and a second fitting coupled to the fluid transfer arm,

wherein the hub is monolithic,

the blood sampling port is 5 mm to 16 mm proximal from the fluid transfer port, and

the venous access device is sterile.

14. A method of performing a blood test, comprising:

obtaining a blood sample from a patient through the venous access device of claim 1; and

performing the blood test with the blood sample obtained from the patient through the venous access device.

15. The method of claim 14, further comprising:

inserting the venous access device into a patient'"'"'s vein.

16. The method of claim 14, wherein the blood test is selected from the group consisting of a blood glucose test, an amylase test, an antinuclear antibody (ANA) test, a partial thromboplastin time (PTT) test, an international normalized ration (INR) test, a prothrombin time (PT) test, a hemoglobin A1C test, a basic metabolite panel (BMP), a complete blood count (CBC) test, a comprehensive metabolic panel (CMP), an electrolyte test, an erythrocyte sedimentation rate (ESR) test, a flu test, a human chorionic gondadotropin (hCG) test, an HIV antibody test, a lipid profile, a liver panel, a microalbumin test, a prostate-specific antigen (PSA) test, and a thyroid-stimulating hormone (TSH) test.

17. The method of claim 16, wherein the blood test is a blood glucose test.

18. The method of claim 14, wherein the patient has diabetes.

19. The method of claim 14, wherein the patient is recovering from cardiac surgery.

20. The method of claim 14, wherein the obtaining occurs while the patient is sleeping.

21. The method of claim 14, further comprising transferring fluids into the patient through the venous access device,

wherein the obtaining and the transferring occur simultaneously.

22. A kit, comprising:

a needle, and

the venous access device of claim 1,

wherein the needle and the venous access device are sterile.

23. The kit of claim 22, further comprising a topical antiseptic.

24. The kit of claim 22, further comprising a tourniquet.

25. The kit of claim 22, further comprising a dressing.

26. The kit of claim 22, further comprising flushing materials.

27. The kit of claim 22, further comprising a container, wherein the needle and the venous access device are housed in the container.

28. The kit of claim 22, further comprising a topical antiseptic,

a tourniquet,

a dressing,

flushing materials,

a set of printed instructions, and

a container,

wherein the needle, the venous access device, the tourniquet, the dressing, the flushing materials, and the set of printed instructions are housed in the container.