Adjustable connector, improved fluid flow and reduced clotting risk

• US 10,028,692 B2
• Filed: 04/23/2014
• Issued: 07/24/2018
• 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
• Primary Examiner(s): Fernandez, Katherine
• Assistant Examiner(s): IMPINK, BRADLEY GERALD
• Application Number:
  US14/259,940
• Publication Number:
  US 20140236047A1
• Time in Patent Office: 1,553 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0437 Trolley or cart-type apparatus
• 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 5/14532 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 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• 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 5/150992 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: A61M 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 2205/0222 Materials for reducing friction
• CPC Class Codes: A61M 2205/0238 : the material being a coating or protective layer
• 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 39/26 : Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

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 sample from a source of fluid, direct a first portion of the withdrawn sample to an analyte monitoring system and return a second portion of the sample. The analyte monitoring system can be connected to the fluid source via a connector that is configured to improve fluid flow and reduce blood clotting risk. These goals can be accomplished, for example, by employing coatings in or on a connector, positioning a resilient substance at or near the junction, by reducing dead space volume, by using resiliency to improve fit, by extending a portion of one connector to better mate with a portion of another connector, etc.

Claims

1. An accommodating medical connector configured to resist blood clot formation, thereby extending a number of hours that the connector may be used for periodic blood withdrawals, the 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 protruding cylindrical tube having a stiffness greater than the standard medical tubing and having an elongate tube axis, the protruding 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 protruding tube forming a fluid path and terminating at a port, the protruding tube configured to;

resiliently press against the standard medical connector when the standard medical connector is securely but removably interlocked with the outer connecting structure to provide a contiguous blood flow path; and

minimize gaps between the standard medical connector and the protruding tube;

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 protruding 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;

a lubricious coating applied to at least a portion of an inner lumen of the protruding tube, the coating configured to lubricate blood-contacting surfaces to reduce blood clotting; and

a sealing mass positioned at or near the tip of the protruding tube, the sealing mass having a shape configured to correspond with a shape of the standard medical connector when the standard medical connector is securely but removably interlocked with the outer connecting structure such that the sealing mass prevents a fluid contained within the protruding tube from leaking out of the port and into the interior volume instead of proceeding into a corresponding lumen of the standard medical connector, and the sealing mass positioned and shaped to function together with the protruding tube, and the protruding tube is aligned with and has a width similar to a width of the corresponding lumen of the standard medical connector, to reduce blood clotting and confine a fluid flow to a fluid path while inhibiting leakage into and clotting within the interior volume outside the fluid path.

2. The accommodating connector of claim 1, wherein the sealing mass has a shape configured to correspond with a shape of the standard medical connector such that the sealing mass shape generally approximates the shape of an opening in the standard medical connector even when the accommodating connector is not mating with the standard medical connector.

3. The accommodating connector of claim 1, wherein at least a portion of the sealing mass has a generally frustoconical shape.

4. The accommodating connector of claim 1, wherein the sealing mass is made from a resilient or compressible material.

5. The accommodating connector of claim 1, wherein the sealing mass is made from silicone.

6. The accommodating connector of claim 1, wherein the lubricious coating is applied to at least a portion of the sealing mass.

7. The accommodating connector of claim 1, wherein the lubricious coating is applied to a surface that is located near an interface between the port and the standard medical connector.

8. The accommodating connector of claim 1, wherein the incoming fluid line comprises a central venous catheter.

9. The accommodating connector of claim 1, wherein the incoming fluid line comprises a peripheral venous catheter.

10. The accommodating connector of claim 1, wherein the incoming fluid line has a width of up to 16 gauge.

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

12. An accommodating medical connector configured to resist blood clot formation, thereby extending a number of hours that the connector may be used for periodic blood withdrawals, the 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 protruding cylindrical tube having a stiffness greater than the standard medical tubing and having an elongate tube axis, the protruding 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 protruding tube forming a fluid path and terminating at a port, the protruding tube configured to;

resiliently press against the standard medical connector when the standard medical connector is securely but removably interlocked with the outer connecting structure to provide a contiguous blood flow path; and

minimize gaps between the standard medical connector and the protruding tube;

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 protruding 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;

a spring configured to exert force on the protruding tube or hub in a direction aligned with the fluid path such that the protruding tube protrudes into the interior volume and resiliently abuts a corresponding 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 corresponding lumen of the standard medical connector, minimizing leakage; and

a sealing mass positioned at or near the tip of the protruding tube, the sealing mass having a shape configured to correspond with a shape of the standard medical connector when the standard medical connector is securely but removably interlocked with the such that the sealing mass prevents a fluid contained within the tube from leaking out of the port and into the interior volume instead of proceeding into the corresponding lumen of the standard medical connector, and the sealing mass positioned and shaped to function together with the protruding tube, and the protruding tube is aligned with and has a width similar to a width of the corresponding lumen of the standard medical connector, to reduce blood clotting and confine a fluid flow to a fluid path while inhibiting leakage into and clotting within the interior volume outside the fluid path.

13. The accommodating connector of claim 12, wherein the sealing mass has a shape configured to correspond with a shape of the standard medical connector such that the sealing mass shape generally approximates the shape of an opening in the standard medical connector even when the accommodating connector is not mating with the standard medical connector.

14. The accommodating connector of claim 12, wherein at least a portion of the sealing mass has a generally frustoconical shape.

15. The accommodating connector of claim 12, wherein the sealing mass is made from a resilient or compressible material.

16. The accommodating connector of claim 12, wherein the sealing mass is made from silicone.

17. The accommodating connector of claim 12, wherein the incoming fluid line comprises a central venous catheter.

18. The accommodating connector of claim 12, wherein the incoming fluid line comprises a peripheral venous catheter.

19. The accommodating connector of claim 12, wherein the incoming fluid line has a width of up to 16 gauge.

20. The accommodating connector of claim 12, wherein the protruding tube comprises polyimide.

21. An accommodating medical connector configured to resist blood clot formation, thereby extending a number of hours that the connector may be used for periodic blood withdrawals, the 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 protruding cylindrical tube having a stiffness greater than the standard medical tubing and having an elongate tube axis, the protruding 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 protruding tube configured to;

resiliently press against the standard medical connector when the standard medical connector is securely but removably interlocked with the outer connecting structure to provide a contiguous blood flow path; and

minimize gaps between the standard medical connector and the protruding tube;

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 protruding 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;

a spring configured to exert force on the protruding tube or hub in a direction aligned with the fluid path such that the protruding tube protrudes into the interior volume and resiliently abuts a corresponding 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 corresponding lumen of the standard medical connector, minimizing leakage; and

a lubricious coating applied to at least a portion of an inner lumen of the protruding tube, the coating configured to lubricate blood-contacting surfaces to reduce blood clotting.

22. The accommodating connector of claim 21, wherein the lubricious coating is applied to at least a portion of the sealing mass.

23. The accommodating connector of claim 21, wherein the lubricious coating is applied to a surface that is located near an interface between the port and the standard medical connector.

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

25. The accommodating connector of claim 21, wherein the incoming fluid line comprises a peripheral venous catheter.

26. The accommodating connector of claim 21, wherein the incoming fluid line has a width of up to 16 gauge.

27. The accommodating connector of claim 21, wherein the protruding tube comprises polyimide.

28. An accommodating medical connector configured to resist blood clot formation, thereby extending a number of hours that the connector may be used for periodic blood withdrawals, the 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 protruding cylindrical tube having a stiffness greater than the standard medical tubing and having an elongate tube axis, the protruding 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 protruding tube forming a fluid path and terminating at a port, the protruding tube configured to;

resiliently press against the standard connector when the standard medical connector is securely but removably interlocked with the outer connecting structure to provide a contiguous blood flow path; and

minimize gaps between the standard medical connector and the protruding tube;

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 protruding 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 sealing mass encircling the protruding tube on the protruding tube'"'"'s outer surface, the sealing mass;

positioned at or near the tip of the protruding tube, thereby configured to provide an interface between the accommodating connector and the standard medical connector;

having a shape configured to correspond with a shape of the standard medical connector when the standard medical connector is removably interlocked with the accommodating connector such that the sealing mass prevents a fluid contained within the protruding tube from leaking out of the port and into the interior volume instead of proceeding into a corresponding lumen of the standard medical connector; and

configured to provide a seal only when the outer connecting structure is securely but removably interlocked with the standard medical connector such that the protruding tube protrudes into the interior volume, the sealing mass thereby positioned and shaped to function together with the protruding tube, and the protruding tube is aligned with and has a width similar to a width of the corresponding lumen of the standard medical connector to reduce blood clotting and confine a fluid flow to a fluid path while inhibiting leakage into and clotting within the interior volume outside the fluid path.

29. The accommodating connector of claim 28, wherein the sealing mass has a shape configured to correspond with a shape of the standard medical connector such that the sealing mass shape generally approximates the shape of an opening in the standard medical connector even when the accommodating connector is not mating with the standard medical connector.

30. The accommodating connector of claim 28, wherein at least a portion of the sealing mass has a generally frustoconical shape.

31. The accommodating connector of claim 28, wherein the sealing mass is made from a resilient or compressible material.

32. The accommodating connector of claim 28, wherein the sealing mass is made from silicone.

33. The accommodating connector of claim 28, wherein the incoming fluid line comprises a central venous catheter.

34. The accommodating connector of claim 28, wherein the incoming fluid line comprises a peripheral venous catheter.

35. The accommodating connector of claim 28, wherein the incoming fluid line has a width of up to 16 gauge.

36. The accommodating connector of claim 28, wherein the protruding tube comprises polyimide.