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

• US 20080027374A1
• Filed: 07/27/2007
• Published: 01/31/2008
• Est. Priority Date: 01/28/2005
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Jensen, Lynn, Clark, Spencer
• Granted Patent: US 7,985,212 B2
• Time in Patent Office: Days
• US Class Current: 604/29
• 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. A container system for peritoneal dialysis (PD) solutions, comprising:

A. a first compartment containing a first PD agent,

B. 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 vessel forming the second compartment folding upon application of force and expelling the second PD agent in connection therewith,

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

D. a second frangible seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the container system,

E. a protective member slideably disposed on the container system to move from a first position, wherein it inhibits breaking of the second frangible seal, to a second position, wherein it does not inhibit breaking of the second frangible seal.

2. The container system of claim 1, wherein the protective member has a slot or other opening sized to slide over at least a portion of a vessel forming the second compartment.

3. The container system of claim 2, wherein presence of a quantity of second PD agent in the second compartment inhibits the slot or other opening from sliding over at least the portion of the vessel forming the second compartment.

4. The container system of claim 3, wherein the slot or other opening is arranged to slide over at least the portion of the vessel forming the second compartment only after a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

5. The container system of claim 4, wherein the slot or other opening is arranged to slide over at least the portion of the vessel forming the second compartment only after at least 10%-30% of a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

6. The container system of claim 4, wherein the slot or other opening is arranged to slide over at least the portion of the vessel forming the second compartment only after at least 30%-50% of a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

7. The container system of claim 4, wherein the slot or other opening is arranged to slide over at least the portion of the vessel forming the second compartment only after at least 75% of a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

8. The container system of claim 4, wherein the slot or other opening is arranged to slide over at least the portion of the vessel forming the second compartment only after substantially all of the second PD agent originally contained in that compartment has been expelled therefrom.

9. The system of claim 1, wherein the first vessel comprises an infusion bag or infusion bottle.

10. The system of claim 1, wherein the second vessel is adapted for manipulation by a patient, health care provider, or other, to facilitate folding thereof.

11. The system of claim 1, wherein any of the first and second frangible seals is adapted for manipulation by a patient, health care provider, or other, to facilitate breaking thereof.

12. The container system of claim 1, wherein the first PD agent is a PD osmotic agent and the second PD agent is a PD buffer agent.

13. The container system of claim 1, wherein, two or more of the first seal, the protective member, and second seal bear visual indicia of an order in which they are to be manipulated by a patient, health care provider or other.

14. The system of claim 13, wherein the visual indicia is coloring.

15. The system of claim 14, wherein the first seal, protective member and second seal are colored differently from one another.

16. (canceled)

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

A. breaking a first seal in a PD container system,

B. folding a first of the PD container system to eject a first PD agent into a second PD agent that is also contained within the PD container system,

C. sliding a protective member at least partially over the first compartment to expose a second seal, and

D. breaking of the second seal to allow fluid to exit the container system via an outlet.

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

A. a first compartment containing a first PD agent,

B. 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 vessel forming the second compartment folding upon application of force and expelling the second PD agent in connection therewith,

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

D. a second seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the container system,

E. a protective member slideably disposed on the container system to move from a first position, wherein it inhibits breaking of the second seal, to a second position, wherein it does not inhibit breaking of the second seal,

F. the protective member including a slot or other opening is arranged to slide over at least a portion of the vessel forming the second compartment only if two or more sides thereof are aligned with the slot and that vessel is at least partially folded,

G. the first and second seals being adapted for breakage via manipulation by a patient, health care provider, or other.

21. The container system of claim 18, wherein the slot or other opening is arranged to slide over at least a portion of the vessel forming the second compartment only if that vessel is at least partially folded, in a manner of butterfly wings.

22. The container system of claim 21, wherein presence of a quantity of second PD agent in the second compartment inhibits the slot or other opening from sliding over at least the portion of the vessel forming the second compartment.

23. The container system of claim 22, wherein the slot or other opening is arranged to slide over at least the portion of the vessel forming the second compartment only after a quantity of second PD agent originally contained in that compartment has been expelled therefrom.

24. The system of claim 18, wherein the protective member has an inner passageway sized to slide over at least a portion of the vessel forming the second compartment.

25. The system of claim 24, 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.

26. The system of claim 25, 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.

27. The system of claim 26, wherein the protective member 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.

29. The container system of claim 18, wherein the first PD agent is a PD osmotic agent and the second PD agent is a PD buffer agent.

19-20. -20. (canceled)

28. (canceled)

30-32. -32. (canceled)

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

A. breaking a first seal in a PD container system of the type 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, a vessel forming the second compartment folding upon application of force and expelling the second PD agent in connection therewith,

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

iv. a second seal that prevents fluid transfer between the second compartment and an outlet fluid pathway of the container system,

v. a protective member slideably disposed on the container system to move from a first position, wherein it inhibits breaking of the second seal, to a second position, wherein it does not inhibit breaking of the second seal,

vi. the protective member including a slot or other opening is arranged to slide over at least a portion of the vessel forming the second compartment if two or more sides thereof are aligned with the slot,

vii. the first and second seals being adapted for breakage via manipulation by a patient, health care provider, or other,

B. sliding the protective member from a first position to a second position, and

C. breaking of the second seal, when the protective member is in the second position, to allow fluid to exit the container system via an outlet.

34-50. -50. (canceled)

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

A. a first compartment containing a first PD agent,

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

C. a diffuser in the fluid pathway,

D. wherein the second compartment folds upon application of force and expels the second PD agent in connection therewith.

52. The container system according to claim 51, comprising a protective member slideably disposed on the container system to move from a first position, wherein it inhibits breaking of the second seal, to a second position, wherein it does not inhibit breaking of the second seal.

53. The container system according to claim 52, wherein the protective member includes a slot or other opening is arranged to slide over at least a portion of the vessel forming the second compartment if two or more sides thereof are aligned with the slot.

54. The container system according to claim 53, wherein the first and second seals are adapted for breakage via manipulation by a patient, health care provider, or other.

55. The container system of claim 52, wherein the protective member has an slot or other opening sized to slide over at least a portion of a vessel forming the second compartment.

56. The container system of claim 55, wherein presence of a quantity of PD buffer agent in the second compartment inhibits the slot or other opening from sliding over at least the portion of the vessel forming the second compartment.

57. The container system of claim 56, wherein the slot or other opening is arranged to slide over at least the portion of the vessel forming the second compartment only after a quantity of PD buffer agent originally contained in that compartment has been expelled therefrom.

61. (canceled)

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

A. a first compartment containing a first PD agent,

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

C. a diffuser in the fluid pathway.

58. The container system of claim 62, wherein, two or more of the first seal, the protective member and second seal bear visual indicia of an order in which they are to be manipulated by a patient, health care provider or other.

59. The system of claim 58, wherein the visual indicia is coloring.

60. The system of claim 59, wherein the first seal, protective member and second seal are colored differently from one another.

63. The container system according to claim 62, wherein the diffuser facilitates mixing of the first and second PD agents.

64. The container system according to claim 63, wherein the first and second PD agents are of different viscosities and/or densities, and wherein the diffuser facilitates homogeneous mixing of those agents.

65. The container system according to claim 63, wherein the diffuser facilitates such mixing during at least one of (i) expulsion of second PD agent from the second compartment into the first compartment, and (ii) expulsion of the second PD agent and the first PD agent from the first compartment.

80. The system of claim 62, wherein the first PD agent is a PD osmotic agent and the second PD agent is a PD buffer agent.

66-67. -67. (canceled)

69. The container system according to claim 68, wherein the diffuser has a proximal end that is disposed within the first compartment.

70. The container system according to claim 68, wherein the diffuser comprises multiple apertures disposed within the first compartment.

74. The container system according to claim 70, wherein the apertures extend from a channel that is in fluid communication with the second compartment and wherein one or more of the apertures extend at an angle therefrom.

75. The container system according to claim 70, wherein the apertures facilitate mixing of the first PD agent with the second PD agent by effecting angular dispersion of the second PD agent into the first PD agent.

76. The container system according to claim 75, wherein the angular dispersion is in the range 40°

-140°

.

77. The container system according to claim 75, wherein the angular dispersion is in the range 60°

-120°

.

78. The container system according to claim 75, wherein the angular dispersion is about 50°

.

71. The container system according to claim 68, wherein one or more of the multiple apertures have a diameter in the range 1.0 mm-1.5 mm.

72-73. -73. (canceled)

79. (canceled)