Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
  • A61M1/285—Catheters therefor

Definitions

• Peritoneal dialysis is finding wide use for the maintenance 5 of patients having end stage renal disease on a chronic basis, and also for various short term treatments.
• Typical modes of peritoneal dialysis include continuous ambulatory peritoneal dialysis (CAP ⁇ ), continuous cycling peritoneal dialysis (CCPU) and intermittent peritoneal dialysis (IPU), all of which are in
• Continuous ambulatory peritoneal dialysis is particularly popular, being one of the lowest cost dialysis techniques, and in which the patient is not tied to a machine, but instead is free to engage in normal activities throughout the entire day.
• 5 Patients have complained about one disadvantage of CAP ⁇ . They have to wear an empty dialysis solution bag and set connected to the peritoneal catheter under their clothing.
• OMPI Bazzato U.S. Patent No. 4,306,976 discloses a system for CAPU in which a set having a Y connection and including a pair of solution containers may be connected to the peritoneal cavity of a patient.
• One of the containers is empty for rece ving 5 spent peritoneal dialysis solution from the patient, wh41e the other container provides peritoneal dialysis solution.
• the connection with the peritoneal catheter includes a cartridge filled with sterilizing material. While this system permits the patient to go through each dwell period without having to carry l ⁇ a solution container with him, the apparatus adds significantly to the expense of peritoneal dialysis, since it requires the use of one Y shaped set of flexible tubing and two flexible containers with each individual dialysis exchange.
• a peritoneal dialysis connection set comprises flexible tubing including a central portion of said tubing having a free end.
• First connector means are carried on the free end and adapted for removable, sealed, flow-through connection with tubing communicating with the peritoneal cavity of a patient, for example the peritoneal catheter.
• At least two lengths of branch tubing communicate with the central tubing portion, each of the lengths of branch tubing defining a free end having second and third connector means carried respectively by the free ends of the lengths of branch tubing.
• the second and third connector means are each adapted for removable, sealed, flow-through connection with a connector communicating with a dialysis solution container so that the connection set is capable of simultaneous communication with two dialysis solution containers.
• the first connector is also adapted for removable, sealed connection with either of the second and third connectors so that, upon disconnection from the patient, the first connector is connected with one of the second and third connectors so that the set can be stored while assuming substantially an "U" shaped
• the other of the second and third connectors typically retains its connection with a typically substantially empty container of peritoneal dialysis solution, so that a compact bundle of the set in "U" shaped configuration and the 5 connected empty container can be easily carried by the patient with him in a small briefcase or the like during his dwell - period, to be ready for reuse for the next peritoneal dialysis exchange.
• the set contains " disinfectant, that, of course, must be removed from the interior of the set prior to administering fresh dialysis solution to the patient. This can be done by causing a small amount of fresh dialysis solution to flow through the two branch lines from the fresh dialysis U solution container to the empty, spent dialysis- solution container, thus washing the disinfectant into the spent dialysis solution container. Also, as spent dialysis solution passes from the patient's peritoneal cavity to the spent dialysis solution container, further washing of the interior of the set 5 is provided.
• Figure 2 is a plan view of the set of this invention in its storage configuration following administration of the peritoneal dialysis solution to the patient and subsequent disconnection
• Figure.3 is a diagramatic view of the set of this invention following reconnect! ' on to the patient, and the added connection of a second container of peritoneal dialysis solution, for draining of spent peritoneal dialysis solution from the patient, and readministration of fresh peritoneal dialysis solution to 15 the patient's peritoneal cavity.
• Connector 22 may be a conventional plastic double seal connector which connects with a titanium adapter 25 carried on the end of catheter 24, being of a design commonly in current use in peritoneal dialysis.
• Tubing 12 communicates with Y connector 26 which, in turn, is connected to two lengths of branch tubing 28, 30 which communicate with central tubing portion 12.
• Y connector 26 which, in turn, is connected to two lengths of branch tubing 28, 30 which communicate with central tubing portion 12.
• Each of said lengths of branch tubing define a free end at which second and third connectors 32, J4 are provided.
• Connectors 32, 34 in this embodiment are shown to be spike connectors, but may be any connector appropriate for the situation.
• connector 34 is in sealed, flow communication with a first collapsible bag 36 of peritoneal dialysis solution. Accordingly, when clamps 20, 38 are open, and clamp 4U is closed, peritoneal dialysis solution from bag 36 flows through peritoneal catheter 24 into the peritoneal cavity of the patient 42 in a customary procedure of peritoneal dialysis. Thereafter, clamps 20, 38 may be closed, and connectors 14, 16 may be disconnected.
• set 10 may be partially or preferably completely filled with a similar disinfectant through tubular connector 14, up to the tube constriction points defined by closed clamps 38, 40 for sterilization of the set. However, a small amount of disinfectant may be allowed to flow into empty bag 36.
• protective cover 43 may be removed and connector 32 may be spiked into connector 14, to place set 10 and attached bag 36 into an "0" shaped configuration with, preferably, antiseptic occupying the interior of the set.
• the set of this invention in the form of Figure 2 may be stored during the "dwell" period, when peritoneal dialysis solution is residing in the patient.
• the patient is free from the burden of having to carry a bag or set 10 during this dwell period, and instead only carries a short transfer set 18 connected to catheter 24.
• catheter 24 itself may 5 be designed to have a connector which connects directly to connector 14 of set 10, eliminating the short transfer set 18. Any appropriate desired design of connectors may be used for this purpose.
• connectors 14 and 32 When it is desired to remove spent peritoneal dialysis l ⁇ solution from the patient's peritoneal cavity, the connection between connectors 14 and 32 is opened. The sealing cap covering connector 16 is removed, and connectors 14 and 16 are brought together again as shown in Figure 3 in a manner similar to Figure 1. Connector 32 is then connected to a second
• clamp 38 is closed and clamp 40 opened, so that fresh peritoneal dialysis solution from bag 46 can flow through sets 10, 18, and catheter 24, into the peritoneal cavity.
• connection between connectors 14, 16 can once again be broken, and connector 16 capped off with a cap of any desired design, optionally placing disinfectant into the outer portion of set 18 as previously described.
• disinfectant may be placed into set 10 through tubular connector 14, following which connector 34 may be disconnected from the refilled solution container 3b, now containing spent dialysis solution and disinfectant, and connectors 14 and 34 may be brought together to put set 10 once again into its " ⁇ "-shaped storage configuration as shown in Figure 4. Note, however, that this time it is the opposite branch tubing 3U and its connector 34 which is in storage connection with connector 14, rather than the previously illustrated situation of Figure 2, where branch tubing 28 and connector 32 were in such connection.
• peritoneal dialysis solution container 46 remains attached to set l ⁇ in the storage mode, being substantially emptied of peritoneal dialysis solution, but optionally containing a small amount of the disinfectant solution applied through connector 14 prior to forming the 0 configuration.
• the patient is free to engage in his activities throughout the dwell period of solution in his peritoneal cavity without having to carry a bag or set 10.
• set 10 in the storage configuration of Figure 4 can be once again opened to break the connection between connectors 14 and 34.
• Connector 14 is reconnected to set 18 through connector 16 (or directly to catheter 24 when such circumstances warrant it), and connector 34 is in turn connected to yet another container of fresh peritoneal dialysis solution.
• the drainage process is repeated with an initial flush of a small amount of fresh dialysis solution passing through branch tubings 30, 28 to fl sh disinfectant into empty bag 46 " .
• the spent peritoneal dialysis solution is then drained through catheter 24 and set l ⁇ into bag 46, following which fresh peritoneal dialysis solution passes through branch tubing 3 ⁇ into the peritoneal cavity.
• connector 32 is disconnected from the refilled bag 46 of spent peritoneal dialysis solution and reconnected to connector 14, to cause the device to once again assume the storage configuration similar to that shown in Figure 2.
• This process is repeated indefinitely from exchange to exchange, with set l ⁇ being reusable for whatever period of time is deemed feasible and desirable.
• set l ⁇ may be reused with approximately four exchanges per day in a CAPD -patient for a period in excess of one week, up to six months or more.
• the patient is freed from being tied to a solution container, which is burdensome and unpleasant even when the container is a collapsible bag, as is typical.
• the patient is also freed from continuous attachment to set 10, so that the only permanent equipment he must carry is the catheter and, where deemed necessary or desirable, the transfer set.

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• Health & Medical Sciences (AREA)
• Emergency Medicine (AREA)
• Urology & Nephrology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• External Artificial Organs (AREA)

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• 1984
  • 1984-09-17 WO PCT/US1984/001480 patent/WO1985002122A1/en not_active Application Discontinuation
  • 1984-09-17 EP EP19840903588 patent/EP0163655A4/de not_active Withdrawn
  • 1984-09-17 JP JP59503543A patent/JPS61500410A/ja active Pending
  • 1984-09-24 IL IL73049A patent/IL73049A/xx not_active IP Right Cessation
  • 1984-09-28 ZA ZA847655A patent/ZA847655B/xx unknown
  • 1984-10-19 IT IT23253/84A patent/IT1177016B/it active
  • 1984-11-13 CA CA000467653A patent/CA1261218A/en not_active Expired

Patent Citations (1)

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