SINGLE-HAND OPERATED SYRINGE-LIKE DEVICE THAT PROVIDES ELECTRONIC CHAIN OF CUSTODY WHEN SECURING A SAMPLE FOR ANALYSIS

• US 20060241515A1
• Filed: 04/21/2006
• Published: 10/26/2006
• Est. Priority Date: 04/21/2005
• Status: Abandoned Application

• Current Assignee: Brigham Young University (The Church of Jesus Christ of Latter-Day Saints)
• Original Assignee: Brigham Young University (The Church of Jesus Christ of Latter-Day Saints)
• Inventors: Truong, Tai Van, Kimball, Jon A., Murray, Jacolin A., Jones, Jeffrey L., Waite, Randall W., Lee, Milton L., Lee, Edgar D.
• Application Number:
  US11/379,716
• Publication Number:
  US 20060241515A1
• Time in Patent Office: Days
• US Class Current: 600/562
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: B01L 2200/087 Ergonomic aspects
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/0845 Filaments, strings, fibres, i.e. not hollow
• CPC Class Codes: B01L 3/0289 Apparatus for withdrawing or distributing predetermined quantities of fluid B01L3/02 takes precedence; sample taking G01N1/00; sample taking within automatic analysers G01N35/00; volume measuring in general G01F

Abstract

A syringe-like device (hereinafter “syringe”) that is operable by a single hand, wherein the syringe includes a plunger for ejecting and then retracting a fiber or filament used for the collection of solids, solids in suspensions and liquids, wherein the syringe includes a microchip embedded in the syringe housing, and wherein the microchip enables electronic chain of custody tracking of a sample from a point of origin through final analysis.

Claims

1. A syringe suitable for obtaining a sample of a substance to be analyzed, wherein the syringe only requires a single hand to operate, and said syringe comprised of:

a fiber suitable for collecting a sample from a substance to be analyzed;

a protective sheath for protecting the fiber, wherein the fiber can be extracted from the protective sheath and retracted back inside;

a plunger for actuating a means for ejecting and retracting the fiber from the protective sheath; and

a thumb actuator coupled to the plunger to thereby push the plunger when fingers grasp the handle and push on the thumb actuator to thereby operate the ejecting and retracting means using a single hand.

2. The syringe as defined in claim 1 wherein the means for ejecting and retracting the fiber is further comprised of:

a cam mechanism disposed inside a handle for locking the fiber into an ejected position; and

for releasing the fiber so that it can be retracted; and

tension means for providing tension for the cam mechanism.

3. The syringe as defined in claim 2 wherein the cam mechanism further comprises a locking position wherein the cam mechanism is held under tension by the tension means when the thumb actuator is pushed a first time to eject the fiber from the protective sheath, and wherein the thumb actuator can be released while the fiber remains in the ejected position.

4. The syringe as defined in claim 3 wherein the cam mechanism further comprises an unlocking position wherein the cam mechanism is released from tension when the thumb actuator is pushed a second time, thereby enabling the fiber to be retracted within the protective sheath.

5. The syringe as defined in claim 3 wherein the cam mechanism further comprises an unlocking position wherein the cam mechanism is released from tension when a release means on a side of the handle is actuated, thereby enabling the fiber to be retracted within the protective sheath.

6. The syringe as defined in claim 3 wherein the cam mechanism further comprises means for enabling the fiber to be ejected in an incremental manner in response to multiple actuations of the thumb actuator until reaching a maximum ejected length of the fiber.

7. The syringe as defined in claim 3 wherein the cam mechanism further comprises means for enabling the fiber to be ejected to a non-incremental length that is directly proportional to a length that the thumb actuator is pushed within the handle.

8. The syringe as defined in claim 1 wherein the syringe further comprises an Identification (ID) circuit disposed thereon, wherein the ID circuit enables electronic chain of custody of a sample obtained by the fiber.

9. The syringe as defined in claim 8 wherein the syringe further comprises at least two electrical connections on an outer surface thereof for enabling communication with the ID circuit.

10. The syringe as defined in claim 9 wherein the ID circuit further comprises at least one memory module, wherein the memory module is non-volatile to thereby enable data retention after power is removed from the ID circuit.

11. The syringe as defined in claim 10 wherein the at least one memory module further comprises memory that can only be written to and read from, but not erased, to thereby ensure the integrity of the electronic chain of custody of the sample.

12. The syringe as defined in claim 10 wherein the at least one memory module further comprises memory that can be written to, read from, and erased in totality, to thereby ensure that if the at least one memory module is being reused, the integrity of the electronic chain of custody of the sample is ensured.

13. The system as defined in claim 1 wherein the system further comprises a recording instrument, wherein the recording instrument can write data to and read data from the ID circuit.

14. The system as defined in claim 13 wherein the recording instrument is a stand-alone device having its own interface to a user such that information can be written to and read from the ID circuit in accordance with commands entered into the recording instrument.

15. The system as defined in claim 13 wherein the recording instrument is coupled to a second device, wherein the second device provides an interface such that information can be written to and read from the ID circuit in accordance with commands entered into the second device.

16. The system as defined in claim 13 wherein the recording instrument is capable of being powered by a battery or an external power source.

17. The system as defined in claim 13 wherein the system further comprises mechanical means for mechanically coupling the syringe to the recording instrument to thereby enable the transfer of the sample to the recording instrument in a hands-free procedure.

18. The syringe as defined in claim 1 wherein the syringe further comprises wireless communication means, wherein the wireless communication means can only be used to transmit data from the ID circuit.

19. The system of a syringe and recording instrument as defined in claim 13 wherein the recording instrument is further comprised of an Analyzer Recording Instrument, wherein the Analyzer Recording Instrument is coupled to an analyzer, and wherein the Analyzer Recording Instrument is specifically designed to operate with a specific analyzer to thereby enhance operation of the system.

20. The system of a syringe and recording instrument as defined in claim 13 wherein the recording instrument is further comprised of:

a first electrical contact coupled to a data input of an I/O driver and an output of a first diode,

a second electrical contact coupled to a ground input of the I/O driver and an input of the first diode; and

a microcontroller coupled to the I/O driver at a Data-In connector and a Data-out connector, and wherein the microcontroller also includes means for communicating to an Internal CPU or an external communications port.

21. The syringe as defined in claim 2 wherein the tension means for providing tension for the cam mechanism is further comprised of a spring.

22. A method for obtaining a sample of a substance to be analyzed by using a syringe that only requires one hand to operate and thereby obtain the sample, said method comprising the steps of:

(1) providing a syringe having a housing wherein is disposed a fiber, a protective sheath, a plunger for actuating means for means for ejecting and retracting the fiber from the protective sheath, and a thumb actuator coupled to the plunger;

(2) grasping the housing of the syringe using fingers of a first hand;

(3) placing a thumb of the first hand on the thumb actuator; and

(4) pushing the thumb actuator with the thumb a first time to thereby actuate the cam mechanism using only the first hand.

23. The method as defined in claim 22 wherein the method further comprises the steps of:

(1) using a cam mechanism disposed inside a handle for locking the fiber into an ejected position; and

for releasing the fiber so that it can be retracted; and

(2) using a spring to provide tension for the cam mechanism.

24. The method as defined in claim 23 wherein the method further comprises the step of pushing the thumb actuator with the thumb a second time to thereby release the cam mechanism and cause the fiber to be retracted within the protective sheath.

25. The method as defined in claim 23 wherein the method further comprises the steps of:

(1) providing a first locking position for the cam mechanism; and

(2) holding the cam mechanism under tension using the spring when the thumb actuator is pushed the first time to eject the fiber from the protective sheath; and

(3) keeping the fiber in the ejected position while releasing the thumb actuator.

26. The method as defined in claim 23 wherein the method further comprises the steps of:

(1) providing an unlocking position for the cam mechanism; and

(2) releasing the tension of the spring by moving the cam mechanism to the unlocking position when the thumb actuator is pushed the second time; and

(3) retracting the fiber within the protective sheath.

27. The method as defined in claim 26 wherein the method further comprises the steps of:

(1) providing means for incrementally ejecting the fiber in response to multiple actuations of the thumb actuator; and

(2) actuating the thumb actuator a plurality of times until reaching a maximum ejected length of the fiber.

28. The method as defined in claim 26 wherein the method further comprises the steps of:

(1) providing means for non-incrementally ejecting the fiber; and

(2) actuating the thumb actuator to thereby eject the fiber a length that is directly proportional to a length that the thumb actuator is pushed within the housing.

29. The method as defined in claim 22 wherein the method further comprises the steps of:

(1) providing an Identification (ID) circuit in the syringe; and

(2) recording information on the ID circuit to thereby enable tracking of an electronic chain of custody of a sample obtained by the fiber.

30. The method as defined in claim 29 wherein the method further comprises the steps of:

(1) providing at least two electrical connections to the ID circuit on an outer surface of the housing; and

(2) storing information on the ID circuit via the at least two electrical connections.

31. The method as defined in claim 30 wherein the method further comprises the step of providing at least one non-volatile memory module in the ID circuit, wherein the memory module retains information stored therein after power is removed from the ID circuit.

32. The method as defined in claim 31 wherein the method further comprises the steps of:

(1) enabling reading from the at least one non-volatile memory module an unlimited number of times;

(2) enabling writing to the at least one non-volatile memory module until memory capacity is reached; and

(3) preventing erasure of any data from the at least one non-volatile memory module to thereby ensure the integrity of the electronic chain of custody of the sample.

33. The method as defined in claim 32 wherein the method further comprises the steps of:

(1) enabling reading from the at least one non-volatile memory module an unlimited number of times;

(2) enabling writing to the at least one non-volatile memory module until memory capacity is reached; and

(3) enabling complete erasure of all data from the at least one non-volatile memory module if the memory module is to be reused, to thereby ensure the integrity of the electronic chain of custody of the sample.

34. The method as defined in claim 22 wherein the method further comprises the step of providing a recording instrument writing to and reading data from the ID circuit.

35. The method as defined in claim 34 wherein the method further comprises the step of providing a stand-alone recording instrument, wherein the recording instrument provides its own interface to a user such that information can be written to and read from the ID circuit in accordance with commands entered into the recording instrument.

36. The method as defined in claim 34 wherein the method further comprises the steps of:

(1) coupling the recording instrument to a second device; and

(2) operating the second device as an interface to the recording instrument, wherein information can be written to and read from the ID circuit in accordance with commands entered into the second device.

37. The method as defined in claim 36 wherein the method further comprises the steps of:

(1) powering the recording instrument with a battery when the recording instrument is operated away from an external power source; and

(2) powering the recording instrument with an external power source when the external power source is available.

38. The method as defined in claim 36 wherein the method further comprises the step of providing a mechanical means for mechanically coupling the syringe to the recording instrument to thereby enable the transfer of the sample to the recording instrument.

39. The method as defined in claim 29 wherein the method further comprises the steps of:

(1) providing wireless communication means; and

(2) only transmitting data from the circuit ID.

40. The method as defined in claim 34 wherein the method further comprises the steps of:

(1) providing an Analyzer Recording Instrument; and

(2) coupling the Analyzer Recording Instrument to a chemical analyzer, wherein the Analyzer Recording Instrument is specifically designed to operate with a specific chemical analyzer to thereby enhance operation of the system.

41. A syringe suitable for obtaining a sample of a substance to be analyzed, wherein the syringe only requires a single hand to operate, and said syringe comprised of:

a fiber suitable for collecting a sample from a substance to be analyzed;

a protective sheath for protecting the fiber, wherein the fiber can be extracted from the protective sheath and retracted back inside;

a plunger for actuating a means for ejecting and retracting the fiber from the protective sheath;

a thumb actuator coupled to the plunger to thereby push the plunger when fingers grasp the handle and push on the thumb actuator to thereby operate the ejecting and retracting means using a single hand; and

an Identification (ID) circuit disposed thereon, wherein the ID circuit enables electronic chain of custody of a sample obtained by the fiber.

42. The syringe as defined in claim 41 wherein the fiber is selected from the group of fibers comprised of SPME fibers, twisted wires, braided wires, and wires forming a whisk.

43. A syringe suitable for obtaining a sample of a substance to be analyzed, wherein the syringe only requires a single hand to operate, and said syringe comprised of:

a fiber suitable for collecting a sample from a substance to be analyzed;

a protective sheath for protecting the fiber, wherein the fiber can be extracted from the protective sheath and retracted back inside;

a plunger for ejecting the fiber from the protective sheath;

a cam mechanism disposed inside a handle for locking the fiber into an ejected position; and

for releasing the fiber so that it can be retracted;

a spring inside the handle for providing tension for the cam mechanism; and

a thumb actuator coupled to the plunger to thereby push the plunger when fingers grasp the handle and push on the thumb actuator to thereby operate the cam mechanism using a single hand.