CA1261218A - Detachable peritoneal dialysis set - Google Patents
Detachable peritoneal dialysis setInfo
- Publication number
- CA1261218A CA1261218A CA000467653A CA467653A CA1261218A CA 1261218 A CA1261218 A CA 1261218A CA 000467653 A CA000467653 A CA 000467653A CA 467653 A CA467653 A CA 467653A CA 1261218 A CA1261218 A CA 1261218A
- Authority
- CA
- Canada
- Prior art keywords
- connector
- patient
- container
- flow
- tubing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
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
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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)
Abstract
DETACHABLE PERITONEAL DIALYSIS SET
Abstract of the Disclosure A peritoneal dialysis connection set comprises flexible tubing (12) including a central portion of the tubing having a free end. First connector means (14) are carried on the free end and adapted for removable, sealed, flow-through connection with tubing communicating with the peritoneal cavity of the patient. At least two lengths of branch tubing (28, 30) communicate with the central tubing portion, each of the lengths of branch tubing defining a free end and respectively carrying second and third connector means (32, 34) at the free ends. The second and third connector means are each adapted for removable, sealed, flow-through connection with a connector communicating with a dialysis solution container, and the first connector (14) is also adapted for removable, sealed connection with either of the second and third connectors (32, 34) in a storage mode of the set. The set can be reused for providing and removing peritoneal dialysis solution from the peritoneal cavity of a patient, and then may be returned to its storage mode and stored separate from the patient during the "dwell" period of peritoneal dialysis therapy.
Abstract of the Disclosure A peritoneal dialysis connection set comprises flexible tubing (12) including a central portion of the tubing having a free end. First connector means (14) are carried on the free end and adapted for removable, sealed, flow-through connection with tubing communicating with the peritoneal cavity of the patient. At least two lengths of branch tubing (28, 30) communicate with the central tubing portion, each of the lengths of branch tubing defining a free end and respectively carrying second and third connector means (32, 34) at the free ends. The second and third connector means are each adapted for removable, sealed, flow-through connection with a connector communicating with a dialysis solution container, and the first connector (14) is also adapted for removable, sealed connection with either of the second and third connectors (32, 34) in a storage mode of the set. The set can be reused for providing and removing peritoneal dialysis solution from the peritoneal cavity of a patient, and then may be returned to its storage mode and stored separate from the patient during the "dwell" period of peritoneal dialysis therapy.
Description
D TACHA~LE PE~lT~NEAL DIALYSlS SET
Technical Field and Prior Art Peritoneal dialysis is finding wide use for the maintenance 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 (CAPD), continuous cycling peritoneal dialysis (CCP~) and intermittent peritoneal dialysis ~IPu), all of which are in lU current clinical use.
~ ontinuous 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.
lS Patients have complained about one disadvantage of CAPU.
They have to wear an empt~ dialysis solution bag and set connected to the peritoneal catheter under their clothing. This requirement results from the extreme sensitivity of CAP~
patients to peritonitis, with the result that many physicians have felt it undesirable to remove the empty peritoneal dialysis solution bag and the transfer set which connects to the peritoneal dialysis catheter during the "dwell" period, i.e., that time in which the peritoneal dialysis solution is residing in the peritoneal cavity without being administered or drained, and during which time the dialysis exchange is taking place.
lt has been suggested to remove the empty dialysis solution bag during the dwell period. For example, the ~eta-~ap sterile closure sold by the ~uinton Instrument Co. is sold for the purposP of capping off CAP~ connections so that the patient can remove the bag. Ho~ever, such a system increases the cost of ChP~, and has not been deemed completely desirable by a majority of physicians.
,. , .
Bazzato U.~. ~dtent No. 4,~06,~76 discloses a system for CAP~ in which a set having d Y connection and including a pair of solution containers may be connected to the peritoneal cavity of a patient. ~ne of the containers is empty for receiving spent peritonedl dialysis solution from the patient, while the other container provides peritoneal dialysis solution. The connection with the peritoneal satheter includes a cartridge filled with sterilizing material. While this system permits the patient to go through each dwell period without having to carry 1~ 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.
An article by ~r. Umberto Buoncristiani et al. entitled 1~ "Abatement of Exogenous Peritonitis Risk Using the Perugia CAP~
~ystem" (Dialysis and Transplantation, ~olume 12 (1~ pp. 14-25 ~ )) discloses a Y shaped, flexible CA~D set which is provided with antiseptic in its interior during the "dwell"
period to permit disconnection of dialysis solution bags from the patient during that period, with allegedly reduced risk of peritonitis. Dr. Buoncristiani's method is also discussed in Italian Pa~ent No. 1,~33,5~, granted August 1~, 1979. However, the patient must wear the Y shaped set during the dwell period, there being no provision for its removal by the techniques ~S described above.
In accordance with this invention, a peritoneal dialysis connection set is provided which is removable and storable during ~he dwell period of the patient, beinq capable of reuse for an apparently theoretically unlimited number of times, without heightened risk of imparting peritonitis to the patient. As a further advantage, only a single bag or other container of peritoneal dialysis solution is consumed per dialysis exchange, with the former fresh dialysis solution bag being ~ypically retained on the stored peritoneal dialysis .
.
, . . .
.
2a connection set for reuse as the spent dialysis solution container.
Since the set can be reused many times, and there is no increase in usage of peritoneal dialysis solution containers over the currently most popular ~orms of CAPD. The disconnectability provided by this invention is provided while the process remains substantially as inexpensive as the least e~pensive current prior ark forms of peritoneal dialysisO At the same time, the patient can enjoy freedom from the burden of having to carry a peritoneal dialysis connection set and an empty container during the dwell period.
Summary of the Inve~ntion Various aspects of the invention are as follows:
Detachable peritoneal dialysis set comprising:
a dialysis solution container having a port for permitting the solution to flow into and out of the container; and a fluid transfer set for selectively enabling bi-directional solution flow between the container and a patient comprising:
a branch connector having first, second, and third branches;
a first flexible tubing having first and second ends, the first end being connected to the first branch of the branch connector, the second end terminating in a first connector adapted to be selectively placed into and removed from sealed flow-through communication with a tube connected with the 0 peritoneal cavity of a patient;
a second flexible tubing having first and second ends, the first end being connected to the second branch of the branch connector, the second end terminating in a second connector adapted to be 5 selectively connected with the container port to permit . .
bi-directional flow of solution between the container and the patient through the first and second tubings when the first connecter is attached in communication with the patient peritoneal cavity tube, the second connector also being adapted when not attached to the container port to be directly connected to the first connector in sealed, flow-through connection therewith when the first connector is removed from communication with the patient peritoneal cavity tube; and a third flexible tubing having first and second ends, the first end being connected with the third branch of the branch connector, the second end terminating in a third connector adapted to be selectively connected with the container port to permit bi-directional flow of solution betwPen the container and the patient through the first and third flexible tubings when the connector is attached in communication with the patient peritoneal cavity tube, the third connector also being adapted when not attached to the container port to be directly connected to the first connector in sealed flow-~hrough connection therewith when the first connector is removed from communication with the patient peritoneal cavity tube, the second flexible tubing including clamp means for controlling flow through the second tubing, so that dialysis solution can bi-directionally flow through the first and third tubings between a container and the patient with no flow occurring in the second flexible tubing, the third flexible tubing including clamp means for controlling flow through the third tubing, so that dialysis solution can bi-directionally flow through the first and second tubings between a container and the patient with no flow occurring in the third flexible tubing, , , , , ~ .
.
' ~Z~ 18 3a so that said set and solution container may be removed from the patient with a selected one o~ said second or third connector connected to the container port and the other one of said selected second or third connectors directly connected to the first connector.
, ~ ~r ~ .~
~ ' ,', .
' ' 3b Description of_the I_vention In accordance with an aspect of this invention 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 cornmunicating 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 adaptecd 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 "O" shaped '`
configuration. The other of the second and third connectors typically retains its connection with a typically substantially empty container of peritoneal dialysis solu~ion, so that a compact bundle of the set in "~" shaped configuration and the connected empty container can be easily carried by the patient ~ith him in a small briefcase or the like during his dwell period, to be ready for reuse for the next peritoneal dialysis exchange.
Typically, the peritoneal dialysis connection set is 1~ substantially filled with a disinfectant, for example, sodium or calcium hypochlorite solution, an iodine solution such as povidone iodine, or any other suitable, known disinfectant.
~ome of the disinfectant solution can be allowed to reside in the attached dialysis solution container, while substantially 1~ the entire interior of the peritoneal dialysis connection set along substantially its entire length is bathed and preferably substantially filled with the disinfectant material. Thus the growth of of bacteria is prevented in the set and desirably the dialysis solution container during each storage period.
~O For use of the peritoneal dialysis set of this invention, one breaks the connection formed between the first connector and one of the second or third connectors, and causes the first connector to connect to tne tubing communicating with the peritoneal cavity of the patient, while connecting the
Technical Field and Prior Art Peritoneal dialysis is finding wide use for the maintenance 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 (CAPD), continuous cycling peritoneal dialysis (CCP~) and intermittent peritoneal dialysis ~IPu), all of which are in lU current clinical use.
~ ontinuous 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.
lS Patients have complained about one disadvantage of CAPU.
They have to wear an empt~ dialysis solution bag and set connected to the peritoneal catheter under their clothing. This requirement results from the extreme sensitivity of CAP~
patients to peritonitis, with the result that many physicians have felt it undesirable to remove the empty peritoneal dialysis solution bag and the transfer set which connects to the peritoneal dialysis catheter during the "dwell" period, i.e., that time in which the peritoneal dialysis solution is residing in the peritoneal cavity without being administered or drained, and during which time the dialysis exchange is taking place.
lt has been suggested to remove the empty dialysis solution bag during the dwell period. For example, the ~eta-~ap sterile closure sold by the ~uinton Instrument Co. is sold for the purposP of capping off CAP~ connections so that the patient can remove the bag. Ho~ever, such a system increases the cost of ChP~, and has not been deemed completely desirable by a majority of physicians.
,. , .
Bazzato U.~. ~dtent No. 4,~06,~76 discloses a system for CAP~ in which a set having d Y connection and including a pair of solution containers may be connected to the peritoneal cavity of a patient. ~ne of the containers is empty for receiving spent peritonedl dialysis solution from the patient, while the other container provides peritoneal dialysis solution. The connection with the peritoneal satheter includes a cartridge filled with sterilizing material. While this system permits the patient to go through each dwell period without having to carry 1~ 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.
An article by ~r. Umberto Buoncristiani et al. entitled 1~ "Abatement of Exogenous Peritonitis Risk Using the Perugia CAP~
~ystem" (Dialysis and Transplantation, ~olume 12 (1~ pp. 14-25 ~ )) discloses a Y shaped, flexible CA~D set which is provided with antiseptic in its interior during the "dwell"
period to permit disconnection of dialysis solution bags from the patient during that period, with allegedly reduced risk of peritonitis. Dr. Buoncristiani's method is also discussed in Italian Pa~ent No. 1,~33,5~, granted August 1~, 1979. However, the patient must wear the Y shaped set during the dwell period, there being no provision for its removal by the techniques ~S described above.
In accordance with this invention, a peritoneal dialysis connection set is provided which is removable and storable during ~he dwell period of the patient, beinq capable of reuse for an apparently theoretically unlimited number of times, without heightened risk of imparting peritonitis to the patient. As a further advantage, only a single bag or other container of peritoneal dialysis solution is consumed per dialysis exchange, with the former fresh dialysis solution bag being ~ypically retained on the stored peritoneal dialysis .
.
, . . .
.
2a connection set for reuse as the spent dialysis solution container.
Since the set can be reused many times, and there is no increase in usage of peritoneal dialysis solution containers over the currently most popular ~orms of CAPD. The disconnectability provided by this invention is provided while the process remains substantially as inexpensive as the least e~pensive current prior ark forms of peritoneal dialysisO At the same time, the patient can enjoy freedom from the burden of having to carry a peritoneal dialysis connection set and an empty container during the dwell period.
Summary of the Inve~ntion Various aspects of the invention are as follows:
Detachable peritoneal dialysis set comprising:
a dialysis solution container having a port for permitting the solution to flow into and out of the container; and a fluid transfer set for selectively enabling bi-directional solution flow between the container and a patient comprising:
a branch connector having first, second, and third branches;
a first flexible tubing having first and second ends, the first end being connected to the first branch of the branch connector, the second end terminating in a first connector adapted to be selectively placed into and removed from sealed flow-through communication with a tube connected with the 0 peritoneal cavity of a patient;
a second flexible tubing having first and second ends, the first end being connected to the second branch of the branch connector, the second end terminating in a second connector adapted to be 5 selectively connected with the container port to permit . .
bi-directional flow of solution between the container and the patient through the first and second tubings when the first connecter is attached in communication with the patient peritoneal cavity tube, the second connector also being adapted when not attached to the container port to be directly connected to the first connector in sealed, flow-through connection therewith when the first connector is removed from communication with the patient peritoneal cavity tube; and a third flexible tubing having first and second ends, the first end being connected with the third branch of the branch connector, the second end terminating in a third connector adapted to be selectively connected with the container port to permit bi-directional flow of solution betwPen the container and the patient through the first and third flexible tubings when the connector is attached in communication with the patient peritoneal cavity tube, the third connector also being adapted when not attached to the container port to be directly connected to the first connector in sealed flow-~hrough connection therewith when the first connector is removed from communication with the patient peritoneal cavity tube, the second flexible tubing including clamp means for controlling flow through the second tubing, so that dialysis solution can bi-directionally flow through the first and third tubings between a container and the patient with no flow occurring in the second flexible tubing, the third flexible tubing including clamp means for controlling flow through the third tubing, so that dialysis solution can bi-directionally flow through the first and second tubings between a container and the patient with no flow occurring in the third flexible tubing, , , , , ~ .
.
' ~Z~ 18 3a so that said set and solution container may be removed from the patient with a selected one o~ said second or third connector connected to the container port and the other one of said selected second or third connectors directly connected to the first connector.
, ~ ~r ~ .~
~ ' ,', .
' ' 3b Description of_the I_vention In accordance with an aspect of this invention 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 cornmunicating 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 adaptecd 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 "O" shaped '`
configuration. The other of the second and third connectors typically retains its connection with a typically substantially empty container of peritoneal dialysis solu~ion, so that a compact bundle of the set in "~" shaped configuration and the connected empty container can be easily carried by the patient ~ith him in a small briefcase or the like during his dwell period, to be ready for reuse for the next peritoneal dialysis exchange.
Typically, the peritoneal dialysis connection set is 1~ substantially filled with a disinfectant, for example, sodium or calcium hypochlorite solution, an iodine solution such as povidone iodine, or any other suitable, known disinfectant.
~ome of the disinfectant solution can be allowed to reside in the attached dialysis solution container, while substantially 1~ the entire interior of the peritoneal dialysis connection set along substantially its entire length is bathed and preferably substantially filled with the disinfectant material. Thus the growth of of bacteria is prevented in the set and desirably the dialysis solution container during each storage period.
~O For use of the peritoneal dialysis set of this invention, one breaks the connection formed between the first connector and one of the second or third connectors, and causes the first connector to connect to tne tubing communicating with the peritoneal cavity of the patient, while connecting the
2~ formerly-connected second or third connector with a fresh container uf peritoneal dia7ysis solution (although this last step may be done at a later point in the process if desired).
One then allows spent peritoneal dialysis solution from the peritoneal cavity of the patient to flow through the central :~U portion of the tubing and the branch tubing which communicates with the substantially empty dialysis solution container, to drain the peritoneal cavity of spent dialysis solution. One then clamps shut the branch tubing communicating with this '~; " . . .
: .
.~3,o~
dialysis solution container, and opens the branch tubing connected with the fresh dialysis solution container. This allows fresh dialysis solution to flow through that branch tubing into the patient's peritoneal cavity while preventing fluid flow through the branch tubing which communicates with the spent dialysi 5 501 ution container.
Une then removes the spent dialysis solution container from connection with its branch tubing for discar~, and one removes the central portion of the tubing from its connection with the 1~ peritoneal cavity tubing~ to expose the two free ends. ~ne then connects those free ends together to restore the set into the "U" configuration. The fresh dialysis solution container is no~
emptied, and remains connected to the "O" set, with the dialysis solution having been safely administered to the patient.
1~ In the event that 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 is provided.
After the draining and refilling of the patient's peritoneal cavity, the "~" set, with its substantially empty connected container which ~ormerly contained the fresh peritoneal dialysis solution, may be stored until the next dialysis procedure, at
One then allows spent peritoneal dialysis solution from the peritoneal cavity of the patient to flow through the central :~U portion of the tubing and the branch tubing which communicates with the substantially empty dialysis solution container, to drain the peritoneal cavity of spent dialysis solution. One then clamps shut the branch tubing communicating with this '~; " . . .
: .
.~3,o~
dialysis solution container, and opens the branch tubing connected with the fresh dialysis solution container. This allows fresh dialysis solution to flow through that branch tubing into the patient's peritoneal cavity while preventing fluid flow through the branch tubing which communicates with the spent dialysi 5 501 ution container.
Une then removes the spent dialysis solution container from connection with its branch tubing for discar~, and one removes the central portion of the tubing from its connection with the 1~ peritoneal cavity tubing~ to expose the two free ends. ~ne then connects those free ends together to restore the set into the "U" configuration. The fresh dialysis solution container is no~
emptied, and remains connected to the "O" set, with the dialysis solution having been safely administered to the patient.
1~ In the event that 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 is provided.
After the draining and refilling of the patient's peritoneal cavity, the "~" set, with its substantially empty connected container which ~ormerly contained the fresh peritoneal dialysis solution, may be stored until the next dialysis procedure, at
3~ which time the process is repeated, with the formerly fresh dialysis solution container assuming the role of the spent dialysis solution container and a new, fresh dialysis solution container being provided for connection with the branch tubing 3~ which currently connects with the central portion tubing of the set in its "~" configuration.
~escription of the ~rawings Referring to the drawings, Figure 1 is a diagramatic view of the set of this invention connected to a patient, through a peritoneal catheter and a transfer set, and connected to a first bag of peritoneal dialysis solution for administration of the -- peritoneal dialysis solution to the patient.
Figure Z is a plan view of the set of this invention in its storage configuration following administration of the per~toneal dialysis solution to ~he patient ancl subsequent disconnection.
1~ Figure ~ is a diagramatic view of the set of this invention following reconnection 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 dialys~s solution to the pa~ient's peritoneal cavity.
Figure 4 is a plan view showing the device of this invention in its alternate storage position, subsequent to disconnection out of the configuration of Figure 3.
~escription of Spe~ific Embodiment Referring to ~he drawings and particularly to Figure 1, set 10 of ~his invention is as previously described, including a central portion of flexible tubing lZ having a free end upon which,a first tubular çonnector 14 is carried, capable of ~5 receiving a spike member lb in sealed relationship. Spike member 1~ constitutes one end of a flexib1e transfer set 18, which constitutes flexible tubing carrying a roller clamp ZU or other clamp of known design, and terminat~ng at its other end in a connector 22 of conventional design for sealing with ~0 peritoneal catheter 24. Connector 2Z may be a convent~onal plastic double seal connector which connects with a titanium adapter 25 carried on the end of catheter ~4, being of a design commonly in current use in peritoneal dialysisO
Tubing l~ communicates with Y connector 26 which, in turn, is connected to two lengths of branch tubing 2~, 30 which communicate with central tubing portion 12. Each of said lengths of branch tubing define a 1ree end at which second and third connectors 32, 34 are provided. Connectors ~, ~4 in this embodiment are shown to be spike connectors, but may be any connector appropriate for the s~tuation.
As shown in Figure l, connector 34 is in sealed, flow communication with a first collapsible bag 3~ of peritoneal dialysis solution. Accordingly, when clamps 2~, 38 are open, and clamp 4~ is closed, peritoneal dialysis solution from bag 3 flows through peritoneal catheter ~4 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. If desired, set 18 may be filled with a disinfectant, such as 0.5 or l percent by weight sodium or calcium hypochlorite solution, up to ~he point of the tube constriction defined by clamp ~, and connector l~ may be capped 2~ off Witt1 an end cap device such as one similar in structure ~o tubular connector 14, but with a closed outer end, to seal spike l~ with the disinfectant occupying the outer portion of set l~.
Also, set lO may be partially or preferably completely filled with a similar disinfectant through tubular connector 14, ~5 up to the tube constriction points defined by closed cla~ps 3~,
~escription of the ~rawings Referring to the drawings, Figure 1 is a diagramatic view of the set of this invention connected to a patient, through a peritoneal catheter and a transfer set, and connected to a first bag of peritoneal dialysis solution for administration of the -- peritoneal dialysis solution to the patient.
Figure Z is a plan view of the set of this invention in its storage configuration following administration of the per~toneal dialysis solution to ~he patient ancl subsequent disconnection.
1~ Figure ~ is a diagramatic view of the set of this invention following reconnection 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 dialys~s solution to the pa~ient's peritoneal cavity.
Figure 4 is a plan view showing the device of this invention in its alternate storage position, subsequent to disconnection out of the configuration of Figure 3.
~escription of Spe~ific Embodiment Referring to ~he drawings and particularly to Figure 1, set 10 of ~his invention is as previously described, including a central portion of flexible tubing lZ having a free end upon which,a first tubular çonnector 14 is carried, capable of ~5 receiving a spike member lb in sealed relationship. Spike member 1~ constitutes one end of a flexib1e transfer set 18, which constitutes flexible tubing carrying a roller clamp ZU or other clamp of known design, and terminat~ng at its other end in a connector 22 of conventional design for sealing with ~0 peritoneal catheter 24. Connector 2Z may be a convent~onal plastic double seal connector which connects with a titanium adapter 25 carried on the end of catheter ~4, being of a design commonly in current use in peritoneal dialysisO
Tubing l~ communicates with Y connector 26 which, in turn, is connected to two lengths of branch tubing 2~, 30 which communicate with central tubing portion 12. Each of said lengths of branch tubing define a 1ree end at which second and third connectors 32, 34 are provided. Connectors ~, ~4 in this embodiment are shown to be spike connectors, but may be any connector appropriate for the s~tuation.
As shown in Figure l, connector 34 is in sealed, flow communication with a first collapsible bag 3~ of peritoneal dialysis solution. Accordingly, when clamps 2~, 38 are open, and clamp 4~ is closed, peritoneal dialysis solution from bag 3 flows through peritoneal catheter ~4 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. If desired, set 18 may be filled with a disinfectant, such as 0.5 or l percent by weight sodium or calcium hypochlorite solution, up to ~he point of the tube constriction defined by clamp ~, and connector l~ may be capped 2~ off Witt1 an end cap device such as one similar in structure ~o tubular connector 14, but with a closed outer end, to seal spike l~ with the disinfectant occupying the outer portion of set l~.
Also, set lO may be partially or preferably completely filled with a similar disinfectant through tubular connector 14, ~5 up to the tube constriction points defined by closed cla~ps 3~,
4~ for sterilization of the set. However~ a small amount of disinfectant may be allowed to flow into empty bag ~
Then, as shown in Figure 2, protec~ive cover 43 may be removed and cGnnector 32 may be spiked into ronnec~or 14, to ~0 place se~ 70 and attached bag 3b into an "0" shaped configuration with, preferably, antiseptic occ~pying the interior of the set.
Thus, the set of this invention in the form of Figure 2 m~y be stored during the "dwell" period, when peritoneal dialysis .
solution is residing in the patient. The patient is free ~rom 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. Alternatively, catheter 24 itself may be designed to have a connector which connects directly to c~nnector 14 of set 10, eliminating the short transfer set 18.
Any appropriate desired design of connectors may be used for this purpose.
~hen it is desired ~o remove spent peritoneal dialysis solution ~rom the patient's peritoneal cavity9 the connection between connectors 14 and 32 is opened. The sealing cap covering connector 1~ is remo~ed, and connectors 14 and 16 are brought together again as shown in Figure :~ in a manner similar to Figure 1. Connector 3~ is then connected to a second peritoneal dialysis sclution bag 4~ so that set 1~ now has branch tubing 2~, ~0 in flow communication with, respectively, bags 46, 36.
Before peritoneal exchange takes place, the disinfectant solution must be removed from the s~stem, to avoid any ~u possibility of disinfectant solution entering the peritoneal cavity. This may be accomplished by opening clamps 33, 409 and allowing a small amount of the fresh peritoneal dialysis solution from bag 4~ to flow through branch tubings ~, 3U into container 36. flushing disinfectant along with it.
~5 Thereafter, clamp 40 is closed and clamp ZO opened, to permi~ spent peritoneal dialysis solution to flow through catheter ~4 and set 1~ back into the first dialysis solution ba~
~ rom where it originally came. ~isinfectant solution is at the same time washed out of sets 18 and la during this process, 3~ and deposited in bag 36.
Following this, clamp 38 is closed and clamp 40 opened, so that fresh ~eritoneal dialysis solution from bag 46 can flow through sets 1~, 18, and catheter 24, into the peritoneal cavity.
".
Following the administration of fresh peritoneal dialysis solution to the peri~cneal cavity, the connec~ion be~ween connectors 14, 16 can once again be broken, and connector 16 capped off with a cap of any desired design, optionally placing disinfPctant into the outer portion of set 18 as previously described.
~ imilarly, disinfectant may be placed into set la through tubular connector 14, following which connector 34 may be disconnected from the refilled solution container 3~, now containing spent dialysis solution and disinfectant, and connectors 14 and 34 may be brought together to put set 10 once again into its "0"-shaped storage con~iguration as shown in Figure 4. Note, however, that this time it is the opposite branch tubing 30 and its connector 34 which is in storage connection with connec~or 14, rather than the previously illustrated situation of Figure 2, where branch tubing 28 and connector :~ were in such connection.
At this time, peritone21 dialysis solution container 46 remains attached to set 1~ in the storage mode, being ~U substantially emptied of peritoneal dialysis solution~ but optionally containing a small amoun~ of ~he disinfectant solution applied through connector 14 prior to forming the 0 configuration. As before, 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.
Thereafter, when once again it is desired to make an exchange, set 1~ in the storage configuration of Figure 4 can be once again opened to break the connection between connectors 14 and ~4. ~onnector 14 is reconnected to set 1~ through connector 16 (or Jirectly to catheter ~4 when such circumstances warrant it), and connector 34 is in turn connected to yet ano~her container of fresh peritoneal dialysis solution. The drainage process is repea~ed wi~h an initial flush of a small amount of fresh dialysis solution passing through branch tubings 3~, ~8 to .
, 1~
flush disinfectant into empty bag 46. The spent peritoneal dialysis solution is then drained through catheter 24 and set lO
into bag 46, following which fresh peritoneal dtalysis solution passes through branch tubing 30 into the peritoneal cavi ty .
Following the reinfusion of fresh peritoneal dialysis solution, 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 ~.
l~ This process is repeated indefinitely from exchange to exchange, with set lO be1ng reusable for whatever period of time is deemed feasible and desirable. Typically set lO 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 l~ more.
By the method and apparatus of this invention, 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 109 SO that the only permanent equipment he must carry is the catheter and, where deemed necessary or desirable, the transfer set.
Through the use of a disinfectant as described herein, the risk of peritonitis can be significantly reduced, for an ?~ effective system of maintenance of a patient by peritoneal dialysis.
The above has been offered for illustrative purposes only, and is not intended to limit the scope of the invention of this application, which is as defined in the claims be70w.
. ~ .
Then, as shown in Figure 2, protec~ive cover 43 may be removed and cGnnector 32 may be spiked into ronnec~or 14, to ~0 place se~ 70 and attached bag 3b into an "0" shaped configuration with, preferably, antiseptic occ~pying the interior of the set.
Thus, the set of this invention in the form of Figure 2 m~y be stored during the "dwell" period, when peritoneal dialysis .
solution is residing in the patient. The patient is free ~rom 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. Alternatively, catheter 24 itself may be designed to have a connector which connects directly to c~nnector 14 of set 10, eliminating the short transfer set 18.
Any appropriate desired design of connectors may be used for this purpose.
~hen it is desired ~o remove spent peritoneal dialysis solution ~rom the patient's peritoneal cavity9 the connection between connectors 14 and 32 is opened. The sealing cap covering connector 1~ is remo~ed, and connectors 14 and 16 are brought together again as shown in Figure :~ in a manner similar to Figure 1. Connector 3~ is then connected to a second peritoneal dialysis sclution bag 4~ so that set 1~ now has branch tubing 2~, ~0 in flow communication with, respectively, bags 46, 36.
Before peritoneal exchange takes place, the disinfectant solution must be removed from the s~stem, to avoid any ~u possibility of disinfectant solution entering the peritoneal cavity. This may be accomplished by opening clamps 33, 409 and allowing a small amount of the fresh peritoneal dialysis solution from bag 4~ to flow through branch tubings ~, 3U into container 36. flushing disinfectant along with it.
~5 Thereafter, clamp 40 is closed and clamp ZO opened, to permi~ spent peritoneal dialysis solution to flow through catheter ~4 and set 1~ back into the first dialysis solution ba~
~ rom where it originally came. ~isinfectant solution is at the same time washed out of sets 18 and la during this process, 3~ and deposited in bag 36.
Following this, clamp 38 is closed and clamp 40 opened, so that fresh ~eritoneal dialysis solution from bag 46 can flow through sets 1~, 18, and catheter 24, into the peritoneal cavity.
".
Following the administration of fresh peritoneal dialysis solution to the peri~cneal cavity, the connec~ion be~ween connectors 14, 16 can once again be broken, and connector 16 capped off with a cap of any desired design, optionally placing disinfPctant into the outer portion of set 18 as previously described.
~ imilarly, disinfectant may be placed into set la through tubular connector 14, following which connector 34 may be disconnected from the refilled solution container 3~, now containing spent dialysis solution and disinfectant, and connectors 14 and 34 may be brought together to put set 10 once again into its "0"-shaped storage con~iguration as shown in Figure 4. Note, however, that this time it is the opposite branch tubing 30 and its connector 34 which is in storage connection with connec~or 14, rather than the previously illustrated situation of Figure 2, where branch tubing 28 and connector :~ were in such connection.
At this time, peritone21 dialysis solution container 46 remains attached to set 1~ in the storage mode, being ~U substantially emptied of peritoneal dialysis solution~ but optionally containing a small amoun~ of ~he disinfectant solution applied through connector 14 prior to forming the 0 configuration. As before, 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.
Thereafter, when once again it is desired to make an exchange, set 1~ in the storage configuration of Figure 4 can be once again opened to break the connection between connectors 14 and ~4. ~onnector 14 is reconnected to set 1~ through connector 16 (or Jirectly to catheter ~4 when such circumstances warrant it), and connector 34 is in turn connected to yet ano~her container of fresh peritoneal dialysis solution. The drainage process is repea~ed wi~h an initial flush of a small amount of fresh dialysis solution passing through branch tubings 3~, ~8 to .
, 1~
flush disinfectant into empty bag 46. The spent peritoneal dialysis solution is then drained through catheter 24 and set lO
into bag 46, following which fresh peritoneal dtalysis solution passes through branch tubing 30 into the peritoneal cavi ty .
Following the reinfusion of fresh peritoneal dialysis solution, 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 ~.
l~ This process is repeated indefinitely from exchange to exchange, with set lO be1ng reusable for whatever period of time is deemed feasible and desirable. Typically set lO 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 l~ more.
By the method and apparatus of this invention, 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 109 SO that the only permanent equipment he must carry is the catheter and, where deemed necessary or desirable, the transfer set.
Through the use of a disinfectant as described herein, the risk of peritonitis can be significantly reduced, for an ?~ effective system of maintenance of a patient by peritoneal dialysis.
The above has been offered for illustrative purposes only, and is not intended to limit the scope of the invention of this application, which is as defined in the claims be70w.
. ~ .
Claims
1. Detachable peritoneal dialysis set comprising:
a dialysis solution container having a port for permitting the solution to flow into and out of the container; and a fluid transfer set for selectively enabling bi-directional solution flow between the container and a patient comprising:
a branch connector having first, second, and third branches;
a first flexible tubing having first and second ends, the first end being connected to the first branch of the branch connector, the second end terminating in a first connector adapted to be selectively placed into and removed from sealed flow-through communication with a tube connected with the peritoneal cavity of a patient;
a second flexible tubing having first and second ends, the first end being connected to the second branch of the branch connector, the second end terminating in a second connector adapted to be selectively connected with the container port to permit bi-directional flow of solution between the container and the patient through the first and second tubings when the first connecter is attached in communication with the patient peritoneal cavity tube, the second connector also being adapted when not attached to the container port to be directly connected to the first connector in sealed, flow-through connection therewith when the first connector is removed from communication with the patient peritoneal cavity tube; and a third flexible tubing having first and second ends, the first end being connected with the third branch of the branch connector, the second end terminating in a third connector adapted to be selectively connected with the container port to permit bi-directional flow of solution between the container and the patient through the first and third flexible tubings when the connector is attached in communication with the patient peritoneal cavity tube, the third connector also being adapted when not attached to the container port to be directly connected to the first connector in sealed flow-through connection therewith when the first connector is removed from communication with the patient peritoneal cavity tube, the second flexible tubing including clamp means for controlling flow through the second tubing, so that dialysis solution can bi-directionally flow through the first and third tubings between a container and the patient with no flow occurring in the second flexible tubing, the third flexible tubing including clamp means for controlling flow through the third tubing, so that dialysis solution can bi-directionally flow through the first and second tubings between a container and the patient with no flow occurring in the third flexible tubing, so that said set and solution container may be removed from the patient with a selected one of said second or third connector connected to the container port and the other one of said selected second or third connectors directly connected to the first connector.
a dialysis solution container having a port for permitting the solution to flow into and out of the container; and a fluid transfer set for selectively enabling bi-directional solution flow between the container and a patient comprising:
a branch connector having first, second, and third branches;
a first flexible tubing having first and second ends, the first end being connected to the first branch of the branch connector, the second end terminating in a first connector adapted to be selectively placed into and removed from sealed flow-through communication with a tube connected with the peritoneal cavity of a patient;
a second flexible tubing having first and second ends, the first end being connected to the second branch of the branch connector, the second end terminating in a second connector adapted to be selectively connected with the container port to permit bi-directional flow of solution between the container and the patient through the first and second tubings when the first connecter is attached in communication with the patient peritoneal cavity tube, the second connector also being adapted when not attached to the container port to be directly connected to the first connector in sealed, flow-through connection therewith when the first connector is removed from communication with the patient peritoneal cavity tube; and a third flexible tubing having first and second ends, the first end being connected with the third branch of the branch connector, the second end terminating in a third connector adapted to be selectively connected with the container port to permit bi-directional flow of solution between the container and the patient through the first and third flexible tubings when the connector is attached in communication with the patient peritoneal cavity tube, the third connector also being adapted when not attached to the container port to be directly connected to the first connector in sealed flow-through connection therewith when the first connector is removed from communication with the patient peritoneal cavity tube, the second flexible tubing including clamp means for controlling flow through the second tubing, so that dialysis solution can bi-directionally flow through the first and third tubings between a container and the patient with no flow occurring in the second flexible tubing, the third flexible tubing including clamp means for controlling flow through the third tubing, so that dialysis solution can bi-directionally flow through the first and second tubings between a container and the patient with no flow occurring in the third flexible tubing, so that said set and solution container may be removed from the patient with a selected one of said second or third connector connected to the container port and the other one of said selected second or third connectors directly connected to the first connector.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US55293683A | 1983-11-17 | 1983-11-17 | |
| US552,936 | 1983-11-17 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1261218A true CA1261218A (en) | 1989-09-26 |
Family
ID=24207425
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000467653A Expired CA1261218A (en) | 1983-11-17 | 1984-11-13 | Detachable peritoneal dialysis set |
Country Status (7)
| Country | Link |
|---|---|
| EP (1) | EP0163655A4 (en) |
| JP (1) | JPS61500410A (en) |
| CA (1) | CA1261218A (en) |
| IL (1) | IL73049A (en) |
| IT (1) | IT1177016B (en) |
| WO (1) | WO1985002122A1 (en) |
| ZA (1) | ZA847655B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AT393213B (en) * | 1989-02-08 | 1991-09-10 | Avl Verbrennungskraft Messtech | DEVICE FOR DETERMINING AT LEAST ONE MEDICAL MEASURING SIZE |
| US6322551B1 (en) * | 1999-07-09 | 2001-11-27 | Gambro Inc. | Break-apart tubing connectors for use in dialysis blood tubing sets |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| USRE25129E (en) * | 1962-02-27 | Apparatus for collecting | ||
| US2452643A (en) * | 1946-05-23 | 1948-11-02 | Abbott Lab | Disposable venoclysis set |
| US3599641A (en) * | 1970-03-13 | 1971-08-17 | David S Sheridan | Combination connector and channel closure system for catheters |
| US4294250A (en) * | 1979-12-07 | 1981-10-13 | Baxter Travenol Laboratories, Inc. | Luer lock connection device |
| FR2493149A1 (en) * | 1980-11-05 | 1982-05-07 | Materiels Annexes Dialyse | DEVICE FOR PROTECTING A CONNECTION TIP BY A DISINFECTANT |
| US4396382A (en) * | 1981-12-07 | 1983-08-02 | Travenol European Research And Development Centre | Multiple chamber system for peritoneal dialysis |
| IT1151884B (en) * | 1982-04-16 | 1986-12-24 | Sis Ter Spa | ENDOPERITONEAL DIALYSIS DEVICE |
-
1984
- 1984-09-17 JP JP59503543A patent/JPS61500410A/en active Pending
- 1984-09-17 WO PCT/US1984/001480 patent/WO1985002122A1/en not_active Application Discontinuation
- 1984-09-17 EP EP19840903588 patent/EP0163655A4/en not_active Withdrawn
- 1984-09-24 IL IL73049A patent/IL73049A/en not_active IP Right Cessation
- 1984-09-28 ZA ZA847655A patent/ZA847655B/en unknown
- 1984-10-19 IT IT23253/84A patent/IT1177016B/en active
- 1984-11-13 CA CA000467653A patent/CA1261218A/en not_active Expired
Also Published As
| Publication number | Publication date |
|---|---|
| EP0163655A1 (en) | 1985-12-11 |
| IT8423253A1 (en) | 1986-04-19 |
| JPS61500410A (en) | 1986-03-13 |
| WO1985002122A1 (en) | 1985-05-23 |
| EP0163655A4 (en) | 1987-04-07 |
| IL73049A0 (en) | 1984-12-31 |
| IL73049A (en) | 1988-07-31 |
| ZA847655B (en) | 1985-05-29 |
| IT8423253A0 (en) | 1984-10-19 |
| IT1177016B (en) | 1987-08-26 |
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| Date | Code | Title | Description |
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| MKEX | Expiry |