Medical material handling systems

• US 20050154368A1
• Filed: 11/19/2004
• Published: 07/14/2005
• Est. Priority Date: 11/21/2003
• Status: Abandoned Application

• Current Assignee: Vasogen Ireland Ltd.
• Original Assignee: Vasogen Ireland Ltd.
• Inventors: Chen, Hao, Matsuura, David G., Simpson, Philip J., Gillespie, Walter Dean, Klein, Gabriele, Worona, Taras, Lim, Bernard C.B., Kanbergs, Davis A.R., Mitchell, John Norris, Muller, Kathleen, Costa, Mark Paul, Zhao, Roy T.
• Application Number:
  US10/991,447
• Publication Number:
  US 20050154368A1
• Time in Patent Office: Days
• US Class Current: 604/403
• CPC Class Codes: A61J 1/1437 Locking means requiring key or combination to open the container
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 39/00 Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use for respiratory devices, e.g. tracheal tubes A61M16/00; artificial heart valves A61F2/24
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491

Abstract

Disclosed herein is a system for the collection, treatment and delivery of an autologous blood sample, comprising a first syringe having a first body portion. A first sample transfer portion has a first syringe inlet for drawing an untreated blood sample from a patient and a first syringe outlet for dispensing the untreated blood sample. A blood sample treatment chamber having a chamber inlet, the first syringe outlet being operable to establish a dedicated first fluid coupling with the chamber inlet to dispense the untreated blood sample to the blood sample treatment chamber. The blood sample treatment chamber having a chamber outlet for dispensing a treated blood sample following treatment. The second syringe has a second body portion and a second sample transfer portion, the second sample transfer portion having a passage with a first access location which is operable to form a dedicated second fluid coupling with the chamber outlet. The second body portion has a second syringe outlet, the passage having a second access location for fluid communication with the second syringe outlet, releasable lock means for forming a locked third fluid coupling between the second access location and the second syringe outlet. The lock means is operable in response to a release signal to release the third fluid coupling, the second syringe outlet being operable when released from the third fluid coupling to form a fourth fluid coupling with a blood sample delivery unit.

Claims

1. A system for the collection, treatment and delivery of an autologous blood sample, comprising:

a first syringe having a first body portion, a first sample transfer portion having a first syringe inlet for drawing an untreated blood sample from a patient and a first syringe outlet for dispensing the untreated blood sample;

a blood sample treatment chamber having a chamber inlet, the first syringe outlet being operable to establish a dedicated first fluid coupling with the chamber inlet to dispense the untreated blood sample to the blood sample treatment chamber;

the blood sample treatment chamber having a chamber outlet for dispensing a treated blood sample following treatment;

a second syringe having a second body portion and a second sample transfer portion, the second transfer portion having a passage with a first access location which is operable to form a dedicated second fluid coupling with the chamber outlet to receive a treated blood sample from said blood sample treatment chamber;

the second body portion having a second syringe outlet;

locking means associated with said second syringe to prevent dispensing of treated blood from said second syringe in the absence of a release signal;

identification means for identifying an originating patient for the untreated blood sample;

verification means for verifying a match between the originating patient and the treated blood sample;

and release signal generating means for generating said release signal in response to a positive verification by the verification means.

2. A system as defined in claim 1 further including:

said passage in said second transfer portion having a second access location for fluid communication with said second syringe outlet;

said locking means forming a locked third fluid coupling between said second access location;

said locking means being operable in response to said release signal to release said third fluid coupling; and

said second syringe outlet being operable when released from said third fluid coupling to form a fourth fluid coupling with a blood sample delivery unit.

3. A system as defined in claim 1 wherein the identification means and/or the release signal generating means is located on the second syringe body.

4. A system as defined in claim claim 1 wherein the identification means and/or the release signal generating means is located on the on the second sample transfer portion, the locking means further comprising signal receiving means for receiving the release signal.

5. A system as defined in claim 1 wherein the identification means and/or the release signal generating means is located on an external article, the locking means further comprising signal receiving means for receiving the release signal.

6. A system as defined in claim 5 wherein the external article is carried by or worn by the originating patient.

7. A system as defined in claim 6 wherein the external article includes a wrist band.

8. A system as defined in claim 6 wherein the external article contains a removable portion containing audit data relating to the patient and/or the treated blood sample.

9. A system as defined in claim 1 wherein the verification means includes comparison means for comparing originating patient identity data with the treated blood sample identity data, signal receiving means to receive one or more signals associated with the originating patient identity data and/or the blood sample identity data, and memory means for storing the patient identity data and the treated blood sample identity data.

10. A system as defined in claim 9 wherein the one or more signals contain the originating patient identity data and/or the blood sample identity data.

11. A system as defined in claim 9, wherein the memory means stores time value data to determine at least one time value related to a predetermined event including or between an untreated blood sample collection event and a treated blood sample delivery event.

12. A system as defined in claim 11 wherein the time value includes at least one elapsed time value between two predetermined events including or between the untreated blood sample collection event and the treated blood sample delivery event.

13. A system as defined in claim 12 wherein the verification means is operable to prevent release of the locked third fluid coupling when the elapsed time value has exceeded a predetermined elapsed time maximum value.

14. A system as defined in claim 12, further comprising a blood treatment unit to treat the blood sample in the blood sample treatment chamber, the verification means being operable to prevent treatment of the blood sample when the elapsed time value has exceeded a predetermined elapsed time maximum value.

15. A system as defined in claim 9 wherein the verification means is operable to verify a match between the untreated blood sample in the first syringe and the originating patient.

16. A system as defined in claim 15 wherein the first syringe is assigned a first syringe identity code which is representative of the untreated blood sample therein, and the originating patient is assigned an originating patient identity code which is representative of the originating patient, wherein the first syringe and originating patient identity codes include related or common data.

17. A system as defined in claim 16 wherein first syringe identity code includes a first time value representative of the time of untreated sample collection from the originating patient and/or verification thereof.

18. A system as defined in claim 16 wherein the second syringe is assigned a second syringe identity code, which is representative of the treated blood sample therein.

19. A system as defined in claim 18 wherein the second syringe identity code includes a second time value representative of the time of the treated sample delivery thereto from the blood sample treatment chamber and/or verification thereof.

20. A system as defined in claim 1 wherein the identification means includes a first signal emitting means for emitting a first signal carrying untreated blood sample identity data and a first signal receiving means to receive the first signal.

21. A system as defined in claim 20 wherein the first signal emitting means is located on the first syringe.

22. A system as defined in claim 1 wherein the identification means includes a second signal emitting means for emitting a second signal carrying the treated blood sample identity data and a second signal receiving means to receive the second signal.

23. A device as defined in claim 22 wherein the second signal emitting means is located on the second syringe.

24. A system as defined in claim 1 wherein the first body portion of the first syringe includes an untreated blood sample receiving chamber and the first sample transfer portion includes a passage joining the untreated blood sample receiving chamber with the first syringe inlet and the first syringe outlet, and first syringe inlet valve means for controlling the flow of blood through the first syringe inlet.

25. A system as defined in claim 24, the first syringe inlet valve means including a septum, further comprising a complementary penetrating member located on or intermediate to the external blood collection article and in an engaged position therewith.

26. A system as defined in claim 1 wherein the second blood sample transfer portion includes a filtered vent outlet in the passage for expelling one or more gas constituents in the treated blood sample.

27. A system as defined in claim 1 wherein one or both of the dedicated first and second couplings are operable releasably to lock the first sample transfer portion of the first syringe and the second sample transfer portion of the second syringe with the blood sample treatment chamber in respective open fluid transfer conditions.

28. A system as defined in claim 27 wherein one or both of the dedicated first and second couplings are operable to establish the locked open fluid transfer condition upon relative rotational displacement between the blood sample treatment chamber and the corresponding first and second sample transfer portions.

29. A system as defined in claim 1 wherein the second syringe outlet includes second syringe outlet valve means for controlling the flow of the blood sample there through.

30. A system as defined in claim 29 wherein the second syringe outlet valve means includes a valve element potion and a valve seat portion, and actuating means for actuating the valve element portion relative to the valve seat portion, the actuating means being operable to displace the valve element from the valve seat portion when the second body portion is engaged with the second sample transfer portion.

31. A system as defined in claim 30 wherein the second sample transfer portion includes a housing to receive the second syringe outlet therein, the housing having a female member in fluid communication with the second access location, the second syringe outlet including a male portion to engage the female portion, the actuating means including an actuating portion adjacent the male portion to be displaced by the female portion on engagement of the female portion with the male portion.

32. A system as defined in claim 31, further comprising an outer sheath portion spaced from the male portion to form an annular female portion-receiving passage therein, the actuating portion including at least one first actuating element positioned in the annular passage.

33. A system as defined in claim 29 wherein the second syringe outlet valve means includes a valve element portion and a valve seat portion, and actuating means for actuating the valve element portion relative to the valve seat portion, the actuating means being operable to engage the valve element with the valve seat portion when the second body portion is separated from the second sample transfer portion, and a second syringe outlet end portion extending outwardly from the second body portion.

34. A system as defined in claim 33 wherein the actuating portion includes at least one second valve actuating element which extends laterally outwardly beyond the second syringe outlet end portion.

35. A system as defined in claim 34 wherein the second outlet end portion has a bevelled distal end and the second valve actuating element has a distal end region which is configured to engage the bevelled distal end of the second outlet end portion.

36. A system as defined in claim 35 wherein the distal end region of the second valve actuating element is angled to nest with the bevelled distal end of the second outlet end portion when the valve element portion is engaged with the valve seat portion.

37. A system as defined in claim 36 wherein the second valve actuating element is arranged to travel along an outside surface of the second outlet end portion as the valve portion is displaced relative to the valve seat portion.

38. A system as defined in claim 37, further comprising a collar member located within the housing, the collar member including a chamber to receive the second outlet end portion to form the third fluid coupling.

39. A system as defined in claim 38 wherein the second valve actuating element includes an abutment flange extending outwardly therefrom, the abutment flange being operable to abut a designated location in the chamber when the second syringe outlet is removed from the chamber.

40. A system as defined as claim 38 wherein the releasable lock means includes a barrier member positioned adjacent the second access location and moveable between a locked position in which the barrier member engages the second outlet end portion, and a release position in which the barrier member is retracted from the second outlet end portion.

41. A system as defined in claim 40 wherein the barrier member is biased to the release position.

42. A system as defined in claim 41, further comprising a brace means for bracing the barrier member in the locked position, wherein the brace means is releasable in the presence of a predetermined current.

43. A material dispensing device, comprising a material container portion and a material transfer portion, the material transfer portion including a passage for the transfer of materials to and from the material container portion, the passage having a first access location in fluid communication with the material container portion and a second access location, and second access location control means for controlling the flow of material through the second access location, the second access location control means including a penetrable septum which is operable in an unpenetrated condition in which the passage is closed and a penetrated condition in which the passage is open, and a third access location, the third access location including a means for forming a dedicated fluid coupling with a medical materials dispenser.

44. A device as defined in claim 43 wherein the material container portion is integrally formed with the material transfer portion.

45. A device as defined in claim 44 wherein the material is a medical fluid.

46. A device as defined in claim 43 wherein the septum includes a block of resilient material.

47. A device as defined in claim 46, the block having a diameter and a depth, wherein the depth approximates the diameter.

48. A device as defined in claim 47, further comprising a septum housing portion containing the septum, the device further comprising a penetrating member for penetrating the septum, the penetrating member being associated with a flange which is engageable with the septum housing portion.

49. A device as defined in claim 48 wherein the flange is complementary with an outer surface on the housing portion.

50. A device as defined in claim 48 wherein the septum housing portion includes an outer web spaced therefrom to form a peripheral cavity to receive the flange on the material transfer portion.

51. A device as defined in claim 43 wherein, in the engaged position, fluid communication is enabled through the penetrating member.

52. A device as defined in claim 51 wherein the penetrating member is a hollow or grooved spike member.

53. A device as defined in claim 52 wherein the septum is located adjacent an end flange, the end flange having an opening with a predetermined cross section to match the cross section of the spike member.

54. A device as defined in claim 53, further comprising an inner septum passage adjacent the end flange, at least one lock member movable between an operable position to obstruct the inner septum passage and an inoperable position, the lock member further including displacement means for displacing the locking member to the inoperable position by the presence of the spike member of a minimum lateral dimension in the inner septum passage.

55. A device as defined in claim 54, further comprising a pair of lock members, each of which includes an outer lock flange and wherein, in the operable position, the lock flanges overlap one another.

56. A device as defined in claim 55 wherein the displacement means includes shank portions located on each lock member adjacent the outer lock flange, the shank portions arranged to lie adjacent one another in the inner septum passage in the operable position, the shank portions being movable to the inoperable position when the spike member of minimum lateral dimension is introduced between the shank portions.

57. A device as defined in claim 48 further including a material delivery portion on which the penetrating member is provided.

58. A device as defined in claim 57 wherein the material delivery portion further comprises a base supporting the penetrating member and the flange on one side thereof.

59. A device as defined in claim 58 wherein the penetrating member is a hollow or grooved spike member and the base further comprises a conduit positioned on a side opposite the spike and in fluid communication therewith.

60. A device as defined in claim 59 wherein the material delivery portion includes a needle and/or needle catheter in fluid communication with the conduit.

61. A device as defined in claim 43 wherein the material container portion includes one or more syringes, IV bottles, powder and/or atomized fluids and/or gas inhalant dispensers, implant delivery dispensers, ventilators, syringe pumps, intubation tubes, gastrointestinal feeding tubes, or a plurality and/or a combination thereof.

62. A material dispensing device, comprising a chamber and an outlet, valve means for controlling the outlet, the valve means including a penetrable septum which is operable in an unpenetrated condition in which the chamber is closed and a penetrated condition in which the chamber is open, the septum including a block of resilient material having a diameter and a depth, wherein the depth approximates the diameter, an end flange, the end flange having an opening with a predetermined cross section, and a penetrating member for penetrating the septum to open the chamber, the penetrating member having a matching cross section which matches the cross section of the opening in close fitting relationship therewith, wherein the opening prevents access to the septum by penetrating members without the matching cross section.

63. A material dispensing device, comprising a chamber and an outlet, valve means for controlling the outlet, the valve means including a penetrable septum which is operable in an unpenetrated condition in which the chamber is closed and a penetrated condition in which the chamber is open, the septum including a block of resilient material having a diameter and a depth, wherein the depth approximates the diameter, the septum having an inner septum passage, at least one lock member movable between an operable position to obstruct the inner septum passage and an inoperable position, the lock member further including displacement means for displacing the locking member to the inoperable position by the presence of a penetrating member of a minimum lateral dimension in the inner septum passage.

64. A device for controlling a medical materials dispenser, comprising a control portion, the control portion having a housing with a passage therein, the passage forming a first fluid coupling with a delivery outlet portion on the medical materials dispenser, and a second fluid coupling with a medical materials receptacle;

and releasable locking means for locking the first fluid coupling, the lock means being operable between a locked condition and unlocked condition in response to an actuation signal generated by an external device.

65. A device as defined in claim 64 wherein the medical materials dispenser includes one or more syringes, JV bottles, powder and/or atomized fluids and/or gas inhalant dispensers, implant delivery dispensers, ventilators, syringe pumps, intubation tubes, gastrointestinal feeding tubes, or a plurality and/or a combination thereof.

66. A device as defined in claim 64 wherein the passage includes a gas discharge vent to permit the gas from the medical materials dispenser to be discharged there through.

67. A system as defined as claim 64 wherein the releasable lock means includes a barrier member moveable between a locked position in which the barrier member engages the delivery outlet portion and a release position in which the barrier member is retracted from the delivery outlet portion.

68. A system as defined in claim 67 wherein the barrier member is biased to the release position.

69. A system as defined in claim 68, further comprising a brace means for bracing the barrier member in the locked position, wherein the brace means is releasable in the presence of a predetermined current.

70. A syringe device comprising a syringe body, the syringe body having a first body portion with a cavity formed therein, a plunger in sealed engagement with the cavity to form a fluid receiving chamber, the syringe body having a second body portion, the second body portion having a passage formed therein, the passage having a first access location in fluid communication with the chamber and a second end terminating at a second access location, the passage having a third access location, wherein at least one of the second and third access locations includes a penetrable septum which is operable in an unpenetrated condition in which the passage is closed and in a penetrated condition in which the passage is open.

71. A device as defined in claim 70 wherein the first syringe body is integrally formed with the second syringe body.

72. A device as defined in claim '"'"'70 wherein the septum includes a block of resilient material, having a diameter and a depth, wherein the depth approximates the diameter.

73. A device as defined in claim 72 wherein the second syringe body portion includes a septum housing portion containing the septum, the device further comprising a penetrating member for penetrating the septum, the penetrating member being associated with a flange which is engageable with the septum housing portion.

74. A device as defined in claim 73 wherein the flange is complementary with an outer surface on the housing portion.

75. A device as defined in claim 74 wherein, in the engaged position, fluid communication is provided through the penetrating member.

76. A method of monitoring a material sample from a patient, comprising the steps of,

collecting the sample from the patient with a first collection device;

associating the patient with a first signal carrying data representative of the sample;

associating the first collection device with a second signal carrying data representative of the sample;

delivering the sample to a sample treatment chamber;

processing the sample to form a processed sample;

collecting the sample in a second collection device;

associating the second collection device with a third signal carrying data representative of the processed sample;

comparing the data in the first and third signals to link the processed sample with the patient; and

thereafter;

permitting the processed sample to be released after a positive association of the data.

77. A method of monitoring a material sample from a patient, comprising the steps of,

collecting the sample from the patient with a first collection device;

associating the patient with a first signal carrying data representative of the sample;

associating the first collection device with a second signal carrying data representative of the sample;

delivering the sample to a sample treatment chamber;

processing the sample to form a processed sample;

collecting the processed sample in a second collection device, wherein the second collection device is locked against release of the process sample in the absence of an unlocking signal;

associating the second collection device with a third signal carrying data representative of the processed sample;

comparing the data in the first and third signals to link the processed sample with the patient; and

thereafter;

unlocking the second collection device to permit release of the processed sample when an unlocking signal is sent after a positive association has been made between the processed sample and the patient.

78. A method of monitoring a material sample from a patient, comprising the steps of,

collecting the sample from the patient with a first collection device;

associating the patient with a first signal carrying data representative of the sample;

associating the first collection device with a second signal carrying data representative of the sample;

delivering the sample to a sample treatment chamber;

processing the sample to form a processed sample;

associating the processed sample with a third signal carrying data representative of the processed sample;

comparing the data in the first and third signals to link the sample as processed with the patient and thereafter;

assembling a patient record including the data in one or more of the first, second and third signals.