SYSTEMS AND METHODS FOR DELIVERING A FLUID TO A PATIENT WITH REDUCED CONTAMINATION

• US 20180177943A1
• Filed: 02/20/2018
• Published: 06/28/2018
• Est. Priority Date: 10/11/2012
• 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.
• Granted Patent: US 10,220,139 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150992 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: A61M 2039/229 Stopcocks
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• 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

Abstract

An apparatus includes a cannula assembly, a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing includes an inlet port removably coupled to the cannula assembly and defines an inner volume. The fluid reservoir is fluidically coupled to the housing and configured to receive and isolate a volume of bodily fluid from a patient. The flow control mechanism is at least partially disposed in the inner volume. The actuator is operably coupled to the flow control mechanism and is configured to move the flow control mechanism between a first configuration, in which bodily fluid can flow, via a fluid flow path defined by the flow control mechanism, from the cannula assembly, through the inlet port and into the fluid reservoir, to a second configuration, in which the fluid reservoir is fluidically isolated from the cannula assembly.

Claims

1-40. -40. (canceled)

41. A bodily fluid sequestration device, comprising:

a housing having a first port configured to be fluidically coupled to a patient and a second port configured to be fluidically coupled to an external fluid reservoir;

an internal fluid reservoir disposed in the housing and configured to receive and sequester an initial volume of bodily fluid withdrawn from the patient;

a flow control mechanism disposed in the housing and defining a first lumen and a second lumen, the first lumen at least partially defining the internal fluid reservoir and configured to fluidically couple the first port to the internal fluid reservoir, and the second lumen configured to fluidically couple the first port to the second port; and

a valve disposed in the first lumen and configured to form a substantially fluid tight seal with the walls defining the first lumen in a closed configuration, and configured to allow the flow of bodily fluid in a single direction in an open configuration,

the bodily fluid sequestration device configured to allow the initial volume of bodily fluid to flow from the first port to the internal fluid reservoir, and to establish a fluid flow path between the first port and the second port once the initial volume of bodily fluid is sequestered in the internal fluid reservoir and the valve is in the closed configuration.

42. The bodily fluid sequestration device of claim 41, wherein the valve is configured to fluidically isolate the internal fluid reservoir from a volume outside the flow control mechanism when the valve is in the closed configuration.

43. The bodily fluid sequestration device of claim 41, wherein the valve is configured to sequester the internal fluid reservoir from the bodily fluid in the second port when the valve is in the closed configuration.

44. The bodily fluid sequestration device of claim 41, wherein the valve is configured such that the second port is fluidically isolated from the internal fluid reservoir when the valve is in a closed position.

45. The bodily fluid sequestration device of claim 41, further comprising:

a cannula assembly including a fluid communicator configured to be inserted into the patient, the cannula assembly configured to be fluidically coupled to the first port of the bodily fluid sequestration device.

46. The bodily fluid sequestration device of claim 45, wherein the initial volume of bodily fluid can flow to the bodily fluid sequestration device until the pressure in the housing is in equilibrium with the pressure of the portion of the patient in which the fluid communicator is disposed.

47. The bodily fluid sequestration device of claim 46, wherein a substantially sterile fluid flow path is established between the first port and the external fluid reservoir after the initial volume of bodily fluid stops flowing to the bodily fluid sequestration device.

48. The bodily fluid sequestration device of claim 41, wherein the bodily fluid sequestration device is configured to transition from a first operating mode in which the initial volume of bodily fluid is allowed to flow from the first port to the internal fluid reservoir, to a second operating mode in which a substantially sterile fluid flow path is established between the first port and the second port.

49. The bodily fluid sequestration device of claim 48, wherein the bodily fluid sequestration device is configured to transition from the first operating mode to the second operating mode without manual intervention.

50. The bodily fluid sequestration device of claim 48, wherein the flow control mechanism is configured to automatically transition the bodily fluid sequestration device from the first operating mode to the second operating mode.

51. The bodily fluid sequestration device of claim 41, wherein the valve is disposed proximate the first port.

52. The bodily fluid sequestration device of claim 41, wherein the valve is disposed between the first port and the internal fluid reservoir.

53. A bodily fluid sequestration device, comprising:

a housing having a first port configured to be fluidically coupled to a patient and a second port configured to be fluidically coupled to an external fluid reservoir;

an internal fluid reservoir disposed in the housing and configured to receive and sequester an initial volume of bodily fluid withdrawn from the patient;

a flow control mechanism disposed in the housing and defining a first lumen and a second lumen, the first lumen at least partially defining the internal fluid reservoir and configured to fluidically couple the first port to the internal fluid reservoir, and the second lumen configured to fluidically couple the first port to the second port; and

a valve disposed in the first lumen and configured to form a substantially fluid tight seal with the walls defining the first lumen in a closed configuration, and configured to allow the flow of bodily fluid in a single direction in an open configuration, the valve being operative to move from the closed configuration to the open configuration in response to a difference in pressure between a valve inlet and a valve outlet,

the bodily fluid sequestration device configured to allow the initial volume of bodily fluid to flow from the first port to the internal fluid reservoir, and to establish a fluid flow path between the first port and the second port once the initial volume of bodily fluid is sequestered in the internal fluid reservoir and the valve is in the closed configuration.

54. The bodily fluid sequestration device of claim 53, wherein the valve is operative to return to the closed configuration in response to equalization of pressure between the valve inlet and the valve outlet.

55. The bodily fluid sequestration device of claim 53, wherein the valve is configured to fluidically isolate the internal fluid reservoir from a volume outside the flow control mechanism when the valve is in the closed configuration.

56. The bodily fluid sequestration device of claim 53, wherein the valve is configured to sequester the internal fluid reservoir from the bodily fluid in the second port when the valve is in the closed configuration.

57. The bodily fluid sequestration device of claim 53, wherein the valve is configured such that the second port is fluidically isolated from the internal fluid reservoir when the valve is in a closed position.

58. The bodily fluid sequestration device of claim 53, further comprising:

a cannula assembly including a fluid communicator configured to be inserted into the patient, the cannula assembly configured to be fluidically coupled to the first port of the bodily fluid sequestration device.

59. The bodily fluid sequestration device of claim 58, wherein the initial volume of bodily fluid can flow to the bodily fluid sequestration device until the pressure in the housing is in equilibrium with the pressure of the portion of the patient in which the fluid communicator is disposed.

60. The bodily fluid sequestration device of claim 53, wherein the bodily fluid sequestration device is configured to transition from a first operating mode in which the initial volume of bodily fluid is allowed to flow from the first port to the internal fluid reservoir, to a second operating mode in which a substantially sterile fluid flow path is established between the first port and the second port.

61. The bodily fluid sequestration device of claim 60, wherein the bodily fluid sequestration device is configured to transition from the first operating mode to the second operating mode without manual intervention.

62. The bodily fluid sequestration device of claim 53, wherein the valve is disposed proximate the first port.

63. A bodily fluid sequestration device, comprising:

a housing having a first port configured to be fluidically coupled to a patient and a second port configured to be fluidically coupled to an external fluid reservoir;

an internal fluid reservoir disposed in the housing and configured to receive and sequester an initial volume of bodily fluid withdrawn from the patient;

a flow control mechanism disposed in the housing and defining a first lumen and a second lumen, the first lumen at least partially defining the internal fluid reservoir and configured to fluidically couple the first port to the internal fluid reservoir, and the second lumen configured to fluidically couple the first port to the second port; and

a valve disposed in the first lumen and configured to form a substantially fluid tight seal with the walls defining the first lumen in a closed configuration,

the valve being operative to move from the closed configuration to an open configuration in response to a difference in pressure between a valve inlet and a valve outlet,

the valve being further operative to return to the closed configuration in response to equalization of pressure between the valve inlet and the valve outlet,

the valve being further configured to sequester the bodily fluid in the internal fluid reservoir from bodily fluid in the second port when the valve is in the closed configuration;

the bodily fluid sequestration device configured to allow the initial volume of bodily fluid to flow from the first port to the internal fluid reservoir, and to establish a fluid flow path between the first port and the second port once the initial volume of bodily fluid is sequestered in the internal fluid reservoir and the valve is in the closed configuration.

64. The bodily fluid sequestration device of claim 63, wherein the valve is configured to fluidically isolate the internal fluid reservoir from a volume outside the flow control mechanism when the valve is in the closed configuration.

65. The bodily fluid sequestration device of claim 63, wherein the valve is configured such that the second port is fluidically isolated from the internal fluid reservoir when the valve is in a closed position.

66. The bodily fluid sequestration device of claim 63, further comprising:

a cannula assembly including a fluid communicator configured to be inserted into the patient, the cannula assembly configured to be fluidically coupled to the first port of the bodily fluid sequestration device.

67. The bodily fluid sequestration device of claim 66, wherein the initial volume of bodily fluid can flow to the bodily fluid sequestration device until the pressure in the housing is in equilibrium with the pressure of the portion of the patient in which the fluid communicator is disposed.

68. The bodily fluid sequestration device of claim 63, wherein the bodily fluid sequestration device is configured to transition from a first operating mode in which the initial volume of bodily fluid is allowed to flow from the first port to the internal fluid reservoir, to a second operating mode in which a substantially sterile fluid flow path is established between the first port and the second port.

69. The bodily fluid sequestration device of claim 68, wherein the bodily fluid sequestration device is configured to transition from the first operating mode to the second operating mode without manual intervention.

70. The bodily fluid sequestration device of claim 63, wherein the valve is disposed proximate the first port.