ADJUSTABLE CONNECTOR AND DEAD SPACE REDUCTION

• US 20140228710A1
• Filed: 04/21/2014
• Published: 08/14/2014
• Est. Priority Date: 07/20/2009
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Butler, Michael, Lim, Eugene, Johnson, Craig
• Granted Patent: US 9,326,717 B2
• Time in Patent Office: Days
• US Class Current: 600/581
• CPC Class Codes: A61B 2560/0228 using calibration standards
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• 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: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/412 : Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6866 : Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61M 2005/14208 : with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2039/1033 : Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 39/10 : Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/1011 : Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 5/1415 : Stands, brackets or the like for supporting infusion accessories
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/16827 : controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 2021/0346 : Capillary cells; Microcells
• CPC Class Codes: G01N 21/03 : Cuvette constructions
• CPC Class Codes: G01N 21/07 : Centrifugal type cuvettes G01N21/09 takes precedence
• CPC Class Codes: G01N 21/35 : using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 33/491 : by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

Methods and systems for determining the concentration of one or more analytes from a sample such as blood or plasma are described. The systems described herein can be configured to withdraw a certain volume of sample from a source of bodily fluid, direct a first portion of the withdrawn sample to an analyte monitoring system and return a second portion of the sample to the patient. The analyte monitoring system can be connected to the source of bodily fluid via a connector that is configured to maintain uniform velocity across the connector and reduce the dead space volume.

Claims

1. An accommodating medical connector configured to reduce leaks and improve fluid flow between a medical device and a source of body fluid, the accommodating connector comprising:

an outer housing having an elongate housing axis, a first side configured to accept standard medical tubing comprising an incoming fluid line, and a connecting side having an outer connecting structure configured to securely but removably interlock with an outer portion of a standard medical connector to form an interior volume;

an elongate cylindrical tube having a stiffness greater than the standard medical tubing and having an elongate tube axis, the tube positioned so its elongate tube axis is generally aligned with and concentric to the elongate housing axis of the outer housing, an interior of the tube forming a fluid path and terminating at a port, the tube configured to extend from the accommodating connector through the outer connecting structure at the connecting side and protrude into the interior volume in a direction aligned with the elongate axis and fluid path such that the tube carries fluid through the interior volume and allows the fluid to flow out of the port and into a lumen of the standard medical connector, the interior of the tube aligned with the lumen and having a diameter that is similar to a diameter of the lumen to improve fluid flow;

a hub within the outer housing, axially aligned with both the incoming fluid line and the elongate tube axis and positioned between them to form a permanent secure connection such that any movement of the tube in a direction of the elongate tube axis and the elongate housing axis causes corresponding movement of the incoming fluid line, the fluid path passing through the hub; and

a spring configured to exert force on the tube or hub in a direction aligned with the fluid path such that the tube protrudes into the interior volume and resiliently abuts the lumen of the standard medical connector such that when fluid passes through the interior volume and out of the port, it continues directly into the aligned lumen of the standard medical connector, minimizing leakage.

2. The accommodating connector of claim 1, wherein the standard medical connector comprises a standard Luer connector, and wherein the accommodating connector is configured to connect with a fluid line attached to a patient.

3. The accommodating connector of claim 2, wherein the fluid line comprises a central venous catheter.

4. The accommodating connector of claim 2, wherein the fluid line comprises a peripheral venous catheter.

5. The accommodating connector of claim 2, wherein the fluid line has a diameter of up to 16 gauge.

6. The accommodating connector of claim 1, wherein the standard medical connector is selected from a group consisting of connectors with standard Luer threading and having a linear depth between an entrance to the standard medical connector and the inner lumen in the range of approximately 6.9 mm to approximately 19.8 mm, and wherein the spring is configured to cause the tube to resiliently protrude through a similar range such that the accommodating medical connector can accommodate standard medical connectors having depths in the range of approximately 6.9 mm to approximately 19.8 mm while protruding fully into the interior volume of each and resiliently abutting the lumen of each such standard medical connector.

7. The accommodating connector of claim 1, wherein the accommodating connector can withstand a pressure of up to approximately 100 psi.

8. The accommodating connector of claim 1, configured to maintain uniform velocity of the bodily fluid across the accommodating connector.

9. The accommodating connector of claim 1, wherein an inner diameter of the tube of the accommodating connector is approximately the same as an inner diameter of the lumen of the standard connector and as a diameter of an internal lumen of the incoming fluid line.

10. The accommodating connector of claim 1, wherein the accommodating connector is configured to reduce dead volume by allowing fluid to bypass the interior volume and avoid flowing into the interior volume.

11. The accommodating connector of claim 1, wherein the tube comprises polyimide.

12. The accommodating connector of claim 2, wherein the tube has a tip at one end which is configured to connect with the fluid line in the patient.

13. The accommodating connector of claim 12, wherein the tip of the tube has a square cross-sectional shape.

14. The accommodating connector of claim 12, wherein the tip of the tube has a conical cross-sectional shape.

15. The accommodating connector of claim 12, wherein the tip of the tube is tapered.

16. The accommodating connector of claim 12, wherein the tip of the tube is beveled.

17. The accommodating connector of claim 12, wherein the tip of the tube comprises a stiff material compared to the lumen of the standard medical connector.

18. The accommodating connector of claim 17, wherein the tip of the tube comprises polyimide.

19. A medical connector comprising:

an outer housing having an elongate housing axis, a first side configured to accept standard medical tubing comprising an incoming fluid line, and a connecting side having an outer connecting structure configured to securely but removably interlock with an outer portion of a standard medical connector having standard luer threading;

an elongate tube having a stiffness greater than the standard medical tubing and having an elongate tube axis, the elongate tube positioned so its elongate tube axis is generally aligned with and concentric to the elongate housing axis of the outer housing, the elongate tube configured to extend from the connector through the outer connecting structure at the connecting side and protrude in a direction aligned with the elongate tube axis and with a fluid path such that the elongate tube allows a fluid to flow into a lumen of the standard medical connector, an interior of the tube aligned with the lumen;

a secure connection between the incoming fluid line and the elongate tube such that any movement of the elongate tube in a direction aligned with the elongate tube and housing axes causes corresponding movement of the incoming fluid line; and

a resilient structure configured to exert force directly or indirectly on the elongate tube in a direction aligned with the fluid path such that the elongate tube resiliently abuts the standard medical connector at an opening to an inner lumen of the standard medical connector, allowing the fluid to flow directly between the elongate tube and the inner lumen of the standard medical connector, minimizing leakage.

20. The medical connector of claim 19, wherein the resilient structure is configured to allow the elongate tube to resiliently protrude to a range of lengths sufficient to mate with and abut the standard medical connector at an opening to the inner lumen of the standard medical connector, the standard medical connectorhaving a depth ranging from at least approximately 6.9 mm to approximately 19.8 mm.

21. The medical connector of claim 19, wherein the incoming fluid line comprises a central venous catheter.

22. The medical connector of claim 19, wherein the incoming fluid line comprises a peripheral venous catheter.

23. The medical connector of claim 19, wherein the incoming fluid line has a diameter of up to 16 gauge.

24. The medical connector of claim 19, wherein the medical connector is configured to reduce dead volume by allowing fluid to bypass an interior volume of the outer housing and avoid flowing into the interior volume.

25. The medical connector of claim 19, wherein the elongate tube comprises polyimide.

26. The medical connector of claim 19, wherein the elongate tube has a tip at one end which is configured to connect with a fluid line in a patient.

27. The medical connector of claim 26, wherein the tip of the elongate tube has a square cross-sectional shape.

28. The medical connector of claim 26, wherein the tip of the elongate tube has a conical cross-sectional shape.

29. The medical connector of claim 26, wherein the tip of the elongate tube is tapered.

30. The medical connector of claim 26, wherein the tip of the elongate tube is beveled.

31. The medical connector of claim 26, wherein the tip of the elongate tube comprises a stiff material compared to the inner lumen of the standard medical connector.

32. The medical connector of claim 26, wherein the tip of the elongate tube comprises polyimide.