Systems and methods for delivery of peritoneal dialysis (PD) solutions

• US 20060186045A1
• Filed: 01/26/2006
• Published: 08/24/2006
• 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 7,837,666 B2
• Time in Patent Office: Days
• US Class Current: 210/645
• 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

1-32. -32. (canceled)

33. 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,

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, and

E. a protective member adapted to inhibit breaking of the second seal prior to breaking of the first seal.

34. The system of claim 33, wherein the first and second seals are frangible.

35. The system of claim 33, wherein the protective member is a cover that is slidably disposed on the container system and that is adapted to move from a first position, wherein the cover inhibits breaking of the second seal, to a second position, wherein the cover does not inhibit breaking of the second seal.

36. The system of claim 35, 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.

37. The system of claim 35, wherein the cover has an inner passageway sized to slide over at least a portion of a vessel forming the second compartment.

38. The system of claim 37, 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.

39. The system of claim 38, 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.

40. The system of claim 39, 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.

41. The system of claim 33, 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.

42. The system of claim 40, wherein the second vessel is configured in the shape of a miniature bulb.

43. The system of claim 42, wherein the first vessel comprises an infusion bag or infusion bottle.

44. The system of claim 42, 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.

45. The system of claim 42, 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.

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

A. a first vessel defining a first compartment that contains a PD osmotic agent,

B. a second vessel defining a second compartment that contains a PD buffer agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment,

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, and

E. a cover that is slidably disposed on the container system and that is adapted to move from a first position, wherein the cover inhibits breaking of the second seal, to a second position, wherein the cover does not inhibit breaking of the second seal.

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

A. a first vessel defining a first compartment that contains a PD osmotic agent,

B. a second vessel defining a second compartment that contains a PD buffer agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment,

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, and

E. the second frangible seal being disposed within the second compartment.

48. The container system of claim 47, wherein that 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.

49. The system of claim 48, wherein the second vessel is configured in the shape of a miniature bulb.

50. The system of claim 48, wherein the first vessel comprises an infusion bag or infusion bottle.

51. The system of claim 49, wherein second vessel is adapted for manipulation by a patient, health care provider, or other, to facilitate breaking at least the second frangible seal.

52. The container system of claim 47, wherein the 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.

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

A. a first vessel defining a first compartment that contains a PD osmotic agent,

B. a second vessel defining a second compartment that contains a PD buffer agent, the second compartment being in any of direct and indirect fluid coupling with the first compartment,

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 piercing member,

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

54. The container system of claim 53, wherein the presence of a quantity of buffer agent in the second compartment prior to breaking of the first seal inhibits compression of the second compartment.

55. The container system of claim 53, wherein the second vessel is configured in the shape of a miniature bulb.

56. The container system of claim 53, wherein the first vessel comprises an infusion bag or infusion bottle.

57. The container system of claim 53, wherein the second vessel is collapsible along an axis substantially aligned with a direction of fluid flow between the first and second compartments.

58. The container system of claim 57, wherein the second vessel has walls that are fan-folded along at least a portion of a length thereof.

59-63. -63. (canceled)