SYSTEMS AND METHODS FOR DELIVERY OF PERITONEAL DIALYSIS (PD) SOLUTIONS

• US 20090078592A1
• Filed: 12/02/2008
• Published: 03/26/2009
• Est. Priority Date: 01/28/2005
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Tuominen, Olli, Jensen, Lynn E., Lan, Jay M.
• Granted Patent: US 8,052,631 B2
• Time in Patent Office: Days
• US Class Current: 206/210
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2027 having frangible parts
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 39/221 Frangible or pierceable closures within tubing A61M39/14 takes precedence; frangible closures for containers A61J1/14
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162

Abstract

The invention provides container systems, kits and methods for peritoneal dialysis (PD) solutions. Such a system, for example, includes a first compartment that contains a PD osmotic agent and a second compartment that contains a PD buffer agent. The compartments maintain their respective contents separately from one another for purposes of transport, storage and/or sterilization. However, the compartments are fluidly couplable, so that their respective contents can be combined with one another, e.g., following sterilization of the agents and prior to their introduction into the patient'"'"'s abdomen. The invention provides, in other aspects, such systems, kits and methods that provide protective structure which inhibits breaking of a seal prior between the second compartment and an outlet of the system, prior to breaking of a seal between the first and second compartments.

Claims

1-63. -63. (canceled)

64. A container system for peritoneal dialysis (PD) solutions, comprising:

a first compartment containing a first PD agent,

a second compartment containing a second PD agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment,

a first seal preventing fluid transfer between the first compartment and the second compartment, and

a second seal preventing fluid transfer out of the second compartment of the container system,

the container system configured to inhibit breaking of the first seal and the second seal at the same time.

65. The container system of claim 64, wherein the container system is configured to inhibit breaking the second seal before breaking the first seal.

66. The container system of claim 65, further comprising:

a protective structure to inhibit breaking the second seal before breaking the first seal.

67. The container system of claim 66, wherein the first and second seals are frangible.

68. The container system of claim 65, further comprising:

a structure disposed to move from a first position to a second position,

wherein breaking of the second seal is inhibited when the structure is in the first position, and breaking of the second seal is not inhibited when the structure is in the second position.

69. The container system of claim 68, wherein the structure comprises a cover that is slideably disposed on the container system.

70. The container system of claim 69, wherein in the first position the cover is disposed in surrounding relation to at least one of

i. the second seal, and

ii. one or more other structures of the container system in vicinity of the second seal that a patient, health care provider, or other manipulates in order to break that second seal.

71. The container system of claim 69, wherein the cover has an inner passageway sized to slide over at least a portion of a vessel forming the second compartment.

72. The container system of claim 71, wherein, prior to breaking of the first seal, movement of the cover from the first position to the second position is restrained by the vessel forming the second compartment.

73. The container system of claim 72, wherein the vessel forming the second compartment has a first outer diameter prior to breaking of the first seal and a lesser outer diameter after breaking of the first seal.

74. The container system of claim 73, wherein the cover has an internal diameter that is (i) smaller than the first outer diameter and (ii) sized to slide over the vessel forming the second compartment when it has the lesser outer diameter.

75. The container system of claim 66, wherein the first compartment is defined by at least a portion of a first vessel and the second compartment is defined by at least a portion of a second vessel.

76. The container system of claim 75, wherein the second vessel is configured in the shape of a miniature bulb.

77. The container system of claim 76, wherein the first vessel comprises an infusion bag or infusion bottle.

78. The container system of claim 76, wherein the second vessel is adapted for manipulation by a patient, health care provider, or other, to facilitate breaking any of the first and second frangible seals.

79. The container system of claim 76, wherein the second vessel comprises rubber, polyolefin, polypropylene, and/or other medical grade material suitable for squeezing, twisting or other manipulation by the patient, health care provider, or other, to facilitate breaking any of the first and second frangible seals.

80. The container system of claim 65, wherein the second seal is disposed such that the second seal is inhibited from manipulation until at least a portion of the second PD agent is expelled to the first compartment.

81. The container system of claim 64, further comprising:

an outlet fluid pathway in fluid communication with the second compartment.

82. The container system of claim 64, wherein the container system can be oriented such that the first seal is above the second seal.

83. The container system of claim 64, wherein at least one of the first seal and the second seal comprises a frangible member.

84. The container system of claim 64, wherein at least one of the first compartment and the second compartment comprise a flexible, medical-grade material.

85. The container system of claim 84, wherein the flexible, medical-grade material comprises at least one of PVC, polyolefin, and polypropylene.

86. The container system of claim 64, further comprises:

an edge that is welded.

87. A container system for peritoneal dialysis (PD) solutions, comprising:

a first compartment containing a first PD agent,

a second compartment containing a second PD agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment,

an outlet fluid pathway coupled to the second compartment being in any of direct and indirect fluid coupling with an external environment to the container system, and

a seal that prevents fluid transfer between the first compartment and the second compartment,

the container system further configured to inhibit fluid transfer to the outlet fluid pathway prior to mixing of at least a portion of the first PD agent and the second PD agent.

88. The container system of claim 87, wherein the seal comprises a first frangible seal, the container system further comprising:

a second frangible seal that prevents fluid transfer between the second compartment and the outlet fluid pathway of the container system, the second frangible seal being disposed within the second compartment.

89. The container system of claim 88, wherein a presence of a quantity of buffer agent in the second compartment prior to breaking of the first seal inhibits breaking of the second seal.

90. The container system of claim 89, wherein the second vessel is configured in the shape of a miniature bulb.

91. The container system of claim 89, wherein the first vessel comprises an infusion bag or infusion bottle.

92. The container system of claim 89, wherein second vessel is adapted for manipulation by a patient, health care provider, or other, to facilitate breaking at least the second frangible seal.

93. The container system of claim 88, wherein a presence of the quantity of buffer agent in the second compartment prior to breaking of the first seal inhibits any of squeezing, twisting or other manipulation of the second vessel for purposes of breaking of the second seal.

94. The container system of claim 88, further comprising:

a piercing member disposed within the second compartment,

the second frangible seal and the piercing member being arranged such that compression of the second compartment results in breaking of the second seal by the piercing member.

95. The container system of claim 94, wherein a presence of a quantity of buffer agent in the second compartment prior to breaking of the first seal inhibits compression of the second compartment.

96. The container system of claim 94, wherein the second vessel is configured in the shape of a miniature bulb.

97. The container system of claim 94, wherein the first vessel comprises an infusion bag or infusion bottle.

98. The container system of claim 94, wherein the second vessel is collapsible along an axis substantially aligned with a direction of fluid flow between the first and second compartments.

99. The container system of claim 98, wherein the second vessel has walls that are fan-folded along at least a portion of a length thereof.

100. The container system of claim 87, further comprising:

a protective structure to inhibit fluid transfer to the outlet fluid pathway prior to mixing of at least a portion of the first PD agent and the second PD agent.

101. The container system of claim 87, wherein the container system is further configured to inhibit fluid transfer to the outlet fluid pathway prior to at least a portion of the second PD agent being expelled into the first compartment.

102. The container system of claim 87, wherein the seal comprises a frangible member.

103. The container system of claim 87, wherein at least one of the first compartment and the second compartment comprise a flexible, medical-grade material.

104. The container system of claim 103, wherein the flexible, medical-grade material comprises at least one of PVC, polyolefin, and polypropylene.

105. The container system of claim 87, further comprises:

an edge that is welded.

106. A method of dispensing a peritoneal dialysis (PD) solution from a PD container system, comprising:

providing the PD container comprising;

(i) a first compartment containing a first PD agent,

(ii) a second compartment containing a second PD agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment, and

(iii) a first seal preventing fluid transfer between the first compartment and the second compartment, and

inhibiting fluid transfer out of the PD container prior to mixing the first PD agent with the second PD agent.

107. The method of claim 106, wherein the PD container further comprises:

a second seal preventing fluid transfer out of the PD container,

wherein the step of inhibiting further comprises inhibiting the second seal from breakage before breakage of the first seal.

108. The method of claim 106, wherein the step of inhibiting comprises inhibiting fluid transfer out of the PD container prior to expelling at least a portion of the second PD agent into the first compartment.

109. A method of dispensing peritoneal dialysis (PD) solution from a PD container system, comprising:

breaking a first seal in a PD container system of the type comprising;

a first compartment that contains a first PD agent and a second compartment that contains a second PD agent, and

squeezing, twisting or otherwise manipulating the second compartment to break a frangible seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the container system to allow fluid to exit the container system via the outlet.