Apparatus and methods for disinfection of a specimen container

• US 10,123,783 B2
• Filed: 03/03/2015
• Issued: 11/13/2018
• Est. Priority Date: 03/03/2014
• Status: Active Grant

• Current Assignee: Magnolia Medical Technologies Limited
• Original Assignee: Magnolia Medical Technologies Limited
• Inventors: Bullington, Gregory J., Patton, Richard G., Gaw, Shan E.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US14/636,485
• Publication Number:
  US 20150246352A1
• Time in Patent Office: 1,351 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 2050/3014 waterproof
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• 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 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/06 Auxiliary integrated devices, integrated components

Abstract

An apparatus includes a transfer adapter, a puncture member, a disinfection member, and a fluid reservoir. The transfer adapter has a proximal end portion and a distal end portion, and defines an inner volume configured to receive the puncture member. The transfer adapter is coupled to the disinfection member. The distal end portion of the transfer adapter includes a port fluidically coupled to the puncture member and configured to be placed in fluid communication with a bodily-fluid of a patient. The proximal end portion is configured to receive a portion of the fluid reservoir to allow the fluid reservoir to be moved within the inner volume between a first position, in which a surface of the fluid reservoir is placed in contact with the disinfection member, and a second position, in which the puncture member punctures the surface to place the puncture member in fluid communication with the fluid reservoir.

Claims

1. An apparatus, comprising:

a transfer adapter including a proximal end portion and a distal end portion and defining an inner volume therebetween, the distal end portion including a port configured to be fluidically coupled to a diversion device in fluid communication with a bodily-fluid of a patient and configured to divert a first volume of bodily-fluid containing contaminants, the transfer adapter configured to receive a second volume of bodily-fluid from the diversion device, the diversion device configured to prevent the second volume of bodily-fluid from flowing to the transfer adapter prior to diverting the first volume of bodily-fluid such that the second volume of bodily-fluid is substantially free of contaminants;

a fluid reservoir including a contact surface and configured to be inserted though the proximal end portion of the transfer adapter such that at least a portion of the fluid reservoir is movably disposed within the inner volume from a first position to a second position;

a disinfection member configured to couple to the transfer adapter and to establish contact with the contact surface of the fluid reservoir to disinfect the contact surface when the fluid reservoir is in the first position; and

a puncture member disposed within the inner volume of the transfer adapter and fluidically coupled to the port, the puncture member configured to couple with the contact surface of the fluid reservoir to establish fluid communication with the fluid reservoir after the disinfection member disinfects the contact surface and after the fluid reservoir is moved from the first position toward the second position,

whereby diverting the first volume of bodily-fluid and disinfecting the contact surface collectively reduce contamination that can result in false results in culture tests of the second volume of bodily-fluid.

2. The apparatus of claim 1, wherein at least a portion of the puncture member is disposed within a sheath, the sheath configured to be transitioned between a first configuration wherein the sheath substantially surrounds the puncture member and a second configuration wherein a portion of puncture member is disposed outside of the sheath.

3. The apparatus of claim 1, wherein the disinfection member is configured to at least partially isolate the puncture member prior to use.

4. The apparatus of claim 1, wherein the disinfection member is configured to be transitioned between a first configuration and a second configuration when the fluid reservoir is moved from the first position to the second position.

5. The apparatus of claim 1, wherein the disinfection member is at least one of a diaphragm or a porous substrate.

6. The apparatus of claim 1, wherein the transfer adapter includes a surface configured to substantially limit distal movement of the fluid reservoir when the fluid reservoir is moved from the first position to the second position.

7. The apparatus of claim 1, wherein the transfer adapter defines a plurality of vents, the plurality of vents configured to allow a disinfection agent to evaporate from the contact surface of the fluid reservoir prior to the fluid reservoir being placed in the second position.

8. The apparatus of claim 1, further comprising:

a seal removably coupled to a surface of the transfer adapter, the seal configured to temporarily fluidically isolate the inner volume defined by the transfer adapter.

9. The apparatus of claim 1, wherein the disinfection member is disposed within a cap removably disposed within the inner volume defined by the transfer adapter, a portion of the fluid reservoir configured to be disposed within the cap when placed in the first position.

10. The apparatus of claim 1, wherein the disinfection member is at least partially disposed within the inner volume of the transfer adapter.

11. The apparatus of claim 1, wherein the transfer adapter includes a retention member, the retention member configured to at least temporarily couple the disinfection member to the transfer adapter.

12. The apparatus of claim 1, wherein the proximal end portion of the transfer adapter defines an opening configured to allow access to the inner volume, the fluid reservoir configured to be inserted through the opening to dispose at least a portion of the fluid reservoir within the inner volume,

the disinfection member configured to couple to the transfer adapter such that the disinfection member at least temporarily obstructs the opening prior to the fluid reservoir being placed in the first position.

13. A method, comprising:

establishing fluid communication between a patient and a transfer adapter via a diversion device, the transfer adapter defining an inner volume that houses a puncture member and a disinfection member, the puncture member configured to receive a sample volume of bodily-fluid from the diversion device, the diversion device configured to prevent a transfer of the sample volume of bodily-fluid prior to withdrawing and sequestering a pre-sample volume of bodily-fluid, the pre-sample volume of bodily-fluid containing contaminants and the sample volume of bodily-fluid being substantially free of contaminants;

inserting a portion of a fluid reservoir into the inner volume of the transfer adapter;

moving the fluid reservoir to a first position in the inner volume to place a contact surface of the fluid reservoir in contact with the disinfection member to at least partially disinfect the contact surface; and

moving the fluid reservoir to a second position, after the disinfection member disinfects the contact surface, such that the puncture member punctures the contact surface of the fluid reservoir to allow the sample volume of bodily-fluid to flow into the fluid reservoir,

whereby diverting the pre-sample volume of bodily-fluid and disinfecting the contact surface collectively reduce contamination that can result in false results in culture tests of the sample volume of bodily-fluid.

14. The method of claim 13, wherein the transfer adapter includes a port, the port configured to be placed in fluid communication with the diversion device, the diversion device being in fluid communication with the patient, the puncture member being in fluid communication with the port.

15. The method of claim 13, wherein the disinfection member is at least one of a diaphragm or a porous substrate.

16. The method of claim 13, wherein the disinfection member is configured to be transitioned between a first configuration and a second configuration when the fluid reservoir is moved from the first position to the second position.

17. The method of claim 13, further comprising:

venting the inner volume of the transfer adapter prior to the moving of the fluid reservoir from the first position to the second position.

18. The method of claim 13, wherein the moving of the fluid reservoir to the second position includes transitioning a sheath from a first configuration in which the puncture member is substantially disposed within the sheath to a second configuration in which a proximal end portion of the puncture member is substantially outside of the sheath.

19. The method of claim 13, wherein the disinfection member at least temporarily obstructs the inner volume of the transfer adapter prior to moving the fluid reservoir to the first position.

20. The method of claim 13, wherein the disinfection member prevents moving the fluid reservoir to the second position prior to moving the fluid reservoir to the first position.