CA2267644A1 - Apparatus for conveying a sterile liquid pulsation-free from or to a sterile container - Google Patents
Apparatus for conveying a sterile liquid pulsation-free from or to a sterile container Download PDFInfo
- Publication number
- CA2267644A1 CA2267644A1 CA002267644A CA2267644A CA2267644A1 CA 2267644 A1 CA2267644 A1 CA 2267644A1 CA 002267644 A CA002267644 A CA 002267644A CA 2267644 A CA2267644 A CA 2267644A CA 2267644 A1 CA2267644 A1 CA 2267644A1
- Authority
- CA
- Canada
- Prior art keywords
- container
- sterile
- bag
- liquid
- pump
- 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.)
- Abandoned
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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
- A61M5/1483—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags using flexible bags externally pressurised by fluid pressure
- A61M5/1486—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags using flexible bags externally pressurised by fluid pressure the bags being substantially completely surrounded by fluid
Landscapes
- Health & Medical Sciences (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Physics & Mathematics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Fluid Mechanics (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Reciprocating Pumps (AREA)
- Loading And Unloading Of Fuel Tanks Or Ships (AREA)
- Basic Packing Technique (AREA)
- External Artificial Organs (AREA)
Abstract
The invention refers to a device for the non-pulsating delivery of liquids.
For this purpose, a flexible (10) bag containing a sterile liquid is introduced in a closed container (11), which is then hermetically sealed. By bleeding the container (11) thoroughly and introducing a liquid, preferably degassed water, the sterile liquid is pressed out of the bag. The bag (10) is connected through a previously assembled and autoclaved connecting unit (1, 4, 7) (for instance with a tapping system) to a sterile processing chamber (16). The medium, which is pressed with an non-sterile feeding device (21) into the container (11), flows as a sterile liquid from the bag (10) into the processing chamber (16). This makes it possible to run constant) non-pulsating flows or specific dosing curves. The system can be further developed to deliver liquid from the container in the opposite direction. The resulting underpressure exerted on the bag makes the medium flow from the sterile processing chamber into the bag, where it can be easily separated from the system.
For this purpose, a flexible (10) bag containing a sterile liquid is introduced in a closed container (11), which is then hermetically sealed. By bleeding the container (11) thoroughly and introducing a liquid, preferably degassed water, the sterile liquid is pressed out of the bag. The bag (10) is connected through a previously assembled and autoclaved connecting unit (1, 4, 7) (for instance with a tapping system) to a sterile processing chamber (16). The medium, which is pressed with an non-sterile feeding device (21) into the container (11), flows as a sterile liquid from the bag (10) into the processing chamber (16). This makes it possible to run constant) non-pulsating flows or specific dosing curves. The system can be further developed to deliver liquid from the container in the opposite direction. The resulting underpressure exerted on the bag makes the medium flow from the sterile processing chamber into the bag, where it can be easily separated from the system.
Description
Nisco Engineering AG
CH-8008 Zurich Non-pulsating Feeding Device for the Delivery of a Sterile t_guid from or to a Sterile Con finer Patent US-A-3,199,511 describes an infusion devlc;e for the treatment of patients) which serves to deliver a liquid to an injection needle. The: patent includes a sealable container. The cover of the container has an opening provided with a plug. On the inside of the container, a bag containing the infusion liquid is connected to the plug and to a hose through a connector in the plug. The hose end is connected to the infusion needle. The inside of the container surrounding the' bag is filled with a liquid, which is delivered through a dosing pump. This allows regulating the liquid delivered through the needle to a flow rate of 0.05 to 10 cm3lmin.
This device is suitable for the delivery of relatively small volumes.
The purpose of the present invention is to provide a device of the type described above that can be used to apportion larger amounts of liquid.
The invention proposes a device as defined in the independent patent claim.
Specific examples, suitable for special uses are defined in the subordinate patent claims.
CH-8008 Zurich Non-pulsating Feeding Device for the Delivery of a Sterile t_guid from or to a Sterile Con finer Patent US-A-3,199,511 describes an infusion devlc;e for the treatment of patients) which serves to deliver a liquid to an injection needle. The: patent includes a sealable container. The cover of the container has an opening provided with a plug. On the inside of the container, a bag containing the infusion liquid is connected to the plug and to a hose through a connector in the plug. The hose end is connected to the infusion needle. The inside of the container surrounding the' bag is filled with a liquid, which is delivered through a dosing pump. This allows regulating the liquid delivered through the needle to a flow rate of 0.05 to 10 cm3lmin.
This device is suitable for the delivery of relatively small volumes.
The purpose of the present invention is to provide a device of the type described above that can be used to apportion larger amounts of liquid.
The invention proposes a device as defined in the independent patent claim.
Specific examples, suitable for special uses are defined in the subordinate patent claims.
The invention also proposes a pump unit connected to one or several delivery devices as described in the invention to ensure an autonomous and flexible pumping process.
The pumping unit described in claim 9 is of particular economic interest, since one pump can be used for different substances.
The following paragraphs describe in more detail the different embodiments and applications of the device in the invention with the help of illustrations.
The illustrations show the following:
Figure 1: Preparing the connecting unit;
Figure 2: Connecting the bag with the autoclaved connector and filling the bag; and Figure 3: Installing the bag. Non-pulsating delivery.
In the example, a cell suspension is delivered to a bioreactor as non-pulsating as possible.
The adapters 1 provided to connect the bags are sealed with a blank cover 2 and connected by means of a sterile hose connector 3 with the hose 4, which has an incorporated tee 5 and a sterile air filter 6. The corresponding sterile connector 7 (piercing unit or suitable autoclavable valve) is attached to the other side of the hose.
The device shown in Figure 1 is the connector) which is then sterilized in the autoclave.
Figure 2 shows how the connection between the autoclaved connector and the bag is achieved. For this purpose) the autoclaved connector is first connected to the bag in the "laminar air bench" by removing the blank cover 2 and making the connection.
The bag is filled in the upright position with the cell suspension) and the bag is bled through the hose 4 and the sterile filter 6. The liquid rises through the adapter 1 in the hose 4 to the clamp 8. When the liquid reaches the clamp) the latter is closed. Then the clamp 9 is closed and the filter 6 is removed. The bag and th~~ connector now form one sterile unit and can be transported to the production room.
The pumping unit described in claim 9 is of particular economic interest, since one pump can be used for different substances.
The following paragraphs describe in more detail the different embodiments and applications of the device in the invention with the help of illustrations.
The illustrations show the following:
Figure 1: Preparing the connecting unit;
Figure 2: Connecting the bag with the autoclaved connector and filling the bag; and Figure 3: Installing the bag. Non-pulsating delivery.
In the example, a cell suspension is delivered to a bioreactor as non-pulsating as possible.
The adapters 1 provided to connect the bags are sealed with a blank cover 2 and connected by means of a sterile hose connector 3 with the hose 4, which has an incorporated tee 5 and a sterile air filter 6. The corresponding sterile connector 7 (piercing unit or suitable autoclavable valve) is attached to the other side of the hose.
The device shown in Figure 1 is the connector) which is then sterilized in the autoclave.
Figure 2 shows how the connection between the autoclaved connector and the bag is achieved. For this purpose) the autoclaved connector is first connected to the bag in the "laminar air bench" by removing the blank cover 2 and making the connection.
The bag is filled in the upright position with the cell suspension) and the bag is bled through the hose 4 and the sterile filter 6. The liquid rises through the adapter 1 in the hose 4 to the clamp 8. When the liquid reaches the clamp) the latter is closed. Then the clamp 9 is closed and the filter 6 is removed. The bag and th~~ connector now form one sterile unit and can be transported to the production room.
Figure 3 shows how the device is connected to the system and delivered non-pulsating.
In the production room, the sterile and sealed bag is introduced into a container 11, which contains one or more incompressible displacement elements 12, used to define the position of the bag and reduce the free volume. The connector is introduced through the opening in the cover 13, then the adapter 1 is locked in position with the locking device 14. The adapter is provided with O-rings, which act as a seal. The cover is attached to the container with the clamp connector' 15. The system is connected to the reactor 16 by means of the corresponding connector 7 provided in the bioreactor.
Now the container is filled with degassed water through valve 17. The container is bled through the bleed valve 18. After the last vestiges of air have been pushed out of the container by the water (visible in the sight glass 19)) valve 17 is closed and valve 20 is opened. A conveying device 21, such as a precision duplex pump, feeds water to the container. Once the level has been checked in the sight glass 19) the bleed valve 18 is closed, whereby a compressive force is applied to the bag.
The clamped-off feed hose 4 can now be opened by releasing clamp 8) resulting in a constant flow to the reactor 16: the same amount ~of non-sterile water that had been pumped into the container now flows from the sterile bag to the reactor.
In the production room, the sterile and sealed bag is introduced into a container 11, which contains one or more incompressible displacement elements 12, used to define the position of the bag and reduce the free volume. The connector is introduced through the opening in the cover 13, then the adapter 1 is locked in position with the locking device 14. The adapter is provided with O-rings, which act as a seal. The cover is attached to the container with the clamp connector' 15. The system is connected to the reactor 16 by means of the corresponding connector 7 provided in the bioreactor.
Now the container is filled with degassed water through valve 17. The container is bled through the bleed valve 18. After the last vestiges of air have been pushed out of the container by the water (visible in the sight glass 19)) valve 17 is closed and valve 20 is opened. A conveying device 21, such as a precision duplex pump, feeds water to the container. Once the level has been checked in the sight glass 19) the bleed valve 18 is closed, whereby a compressive force is applied to the bag.
The clamped-off feed hose 4 can now be opened by releasing clamp 8) resulting in a constant flow to the reactor 16: the same amount ~of non-sterile water that had been pumped into the container now flows from the sterile bag to the reactor.
Thermo-sensitive cell suspensions can be cooled down during the introduction by means of a cooling unit 22. A temperature measuring system 23 can also be integrated.
As soon as the bag is empty, the pressure in the container increases noticeably. The pumps can be stopped automatically by means of pressure sensors 24. A new bag can then be introduced.
As shown in Figure 3, in addition to one container 111, a second similar container 11' can be provided, whereby the bag contained in it is also connected to the reactor 16 by means of a connector 1', 4', 7'. The second container 11' is also filled with water through valve 17'. When the bag 10 in the first coni:ainer 11 is empty, the pump 21 can be switched by means of valve 20 to the second container 11') so that the apportioning of the sterile liquid can be continued without interruptions. Then valve 18 is opened and water in the first container 11 is drained through valve 17, the cover 13 is removed and the empty bag 10 with the connector 1) 4, 7 is replaced with a new unit. The container 11 can now be prepared as described earlier for the next delivery process.
Depending on the use, the bag in the second container 11' can contain another liquid. In that case, it would be useful to provide a separate pump 21 for this container 11'.
The procedure for delivering a sterile liquid in a sterile processing chamber using the delivery device described in the invention involves the following steps:
1. Autoclaving the appropriate connector and connecting it to a sterile bag.
2. Filling the sterile bag with a liquid under sterile conditions.
3. Sealing the connection and introducing the bag in a solid container.
4. Closing the container with a sealing device.
As soon as the bag is empty, the pressure in the container increases noticeably. The pumps can be stopped automatically by means of pressure sensors 24. A new bag can then be introduced.
As shown in Figure 3, in addition to one container 111, a second similar container 11' can be provided, whereby the bag contained in it is also connected to the reactor 16 by means of a connector 1', 4', 7'. The second container 11' is also filled with water through valve 17'. When the bag 10 in the first coni:ainer 11 is empty, the pump 21 can be switched by means of valve 20 to the second container 11') so that the apportioning of the sterile liquid can be continued without interruptions. Then valve 18 is opened and water in the first container 11 is drained through valve 17, the cover 13 is removed and the empty bag 10 with the connector 1) 4, 7 is replaced with a new unit. The container 11 can now be prepared as described earlier for the next delivery process.
Depending on the use, the bag in the second container 11' can contain another liquid. In that case, it would be useful to provide a separate pump 21 for this container 11'.
The procedure for delivering a sterile liquid in a sterile processing chamber using the delivery device described in the invention involves the following steps:
1. Autoclaving the appropriate connector and connecting it to a sterile bag.
2. Filling the sterile bag with a liquid under sterile conditions.
3. Sealing the connection and introducing the bag in a solid container.
4. Closing the container with a sealing device.
5. Connecting it to a sterile processing chamber by means of the connector.
6. Filling the container completely with a degas>sed liquid.
7. Opening the connection to the sterile processing chamber.
8. Feeding degassed liquid to the container and then delivering liquid from the sterile bag to the sterile processing chamber.
9. Once the bag is empty (Pressure in the container increases):
a) Switching to a parallel delivery system by means of a three-way valve for quasi-stationary delivery; or b) Opening the container and changing the bag.
The procedure for the removal of a sterile liquid from a sterile processing chamber using the delivery device in the invention, involves the following steps:
1. Autoclaving the appropriate connector and connecting it to a sterile bag.
2. Sealing the connection and introducing the bag in a solid container.
3. Closing the container with a sealing device.
4. Connecting it to a sterile processing chamber by means of the connector.
5. Filling the container completely with a degassed liquid.
6. Opening the connection to the sterile processing chamber.
7. Delivering degassed liquid from the container and then delivering liquid to the sterile bag from the sterile processing chamber.
8. Once the bag is full:
a) Switching to a parallel bag by means of a three-way valve; or b) Opening the container and removing the bag.
The advantages of this delivery device are the following:
1. A liquid can be delivered with simple means. in a non-pulsating flow to a sterile chamber.
2. The flow can be easily measured with flow rneters or measurements in the pump.
3. Space requirements and contamination danger are minimized.
4. It is possible to run any type of dosing and Extracting curves or a constant flow.
5. Because the bag 10 in the container 11 is supported by the displacement element 12 and the cylindrical container is essentially in a horizontal or slightly inclined position, its connection with the adapter 1 is not strained, not even before it is filled with water. This allows using bags 10 with considerably larger capacity than in the device mentioned initially. The horizontal position has the additional advantage, that the bag content ~;an be emptied more thoroughly than in the hanging position) particularly when both liquids have a different specific gravity.
6. The displacement elements 12 allow minimizing the water volume to be filled.
This means that it can be put into operation quickly, even when the capacity of the bags 10 varies considerably.
7. By adding a second container 11' it is possible to apportion liquid in a practically uninterrupted fashion.
a) Switching to a parallel delivery system by means of a three-way valve for quasi-stationary delivery; or b) Opening the container and changing the bag.
The procedure for the removal of a sterile liquid from a sterile processing chamber using the delivery device in the invention, involves the following steps:
1. Autoclaving the appropriate connector and connecting it to a sterile bag.
2. Sealing the connection and introducing the bag in a solid container.
3. Closing the container with a sealing device.
4. Connecting it to a sterile processing chamber by means of the connector.
5. Filling the container completely with a degassed liquid.
6. Opening the connection to the sterile processing chamber.
7. Delivering degassed liquid from the container and then delivering liquid to the sterile bag from the sterile processing chamber.
8. Once the bag is full:
a) Switching to a parallel bag by means of a three-way valve; or b) Opening the container and removing the bag.
The advantages of this delivery device are the following:
1. A liquid can be delivered with simple means. in a non-pulsating flow to a sterile chamber.
2. The flow can be easily measured with flow rneters or measurements in the pump.
3. Space requirements and contamination danger are minimized.
4. It is possible to run any type of dosing and Extracting curves or a constant flow.
5. Because the bag 10 in the container 11 is supported by the displacement element 12 and the cylindrical container is essentially in a horizontal or slightly inclined position, its connection with the adapter 1 is not strained, not even before it is filled with water. This allows using bags 10 with considerably larger capacity than in the device mentioned initially. The horizontal position has the additional advantage, that the bag content ~;an be emptied more thoroughly than in the hanging position) particularly when both liquids have a different specific gravity.
6. The displacement elements 12 allow minimizing the water volume to be filled.
This means that it can be put into operation quickly, even when the capacity of the bags 10 varies considerably.
7. By adding a second container 11' it is possible to apportion liquid in a practically uninterrupted fashion.
Claims (10)
1. Delivery device for delivering liquids in a sterile and non-pulsating fashion from or to a processing chamber, consisting of a container (11) sealed from its surroundings, provided with connecting means (1, 4, 7) for connecting a bag (10) to be placed in the interior of the container (11), the former being intended to receive or discharge the liquid and to deliver or receive it non-pulsating to or from the external processing chamber (16) through a first set of elements (1, 4, 7)) whereby the inner chamber is connected through a second set of elements (20) to a pump (21), used to deliver an incompressible, sterile or non-sterile medium which acts directly on the external side of the bag (10) to or from the inner chamber, the container (11) having at least one supporting element for the bag (10).
2. Device according to claim 1, in which the inside contains at least one replaceable, incompressible insertable element (12) that reduces the intake volume of the medium delivered by the pump, and the container (11) preferably has a removable cover (13).
3. Device according to claim 2, in which the supporting element either forms one piece with the insertable element (12) or is independent from the same.
4, Device according to one of claims 1 to 3, provided with a thermostat (23) and / or a pressure sensor (24) in the space occupied by the medium delivered by the pump (21).
5. Device according to one of claims 1 to 4, in which the container (11) is cylindrical and placed in a horizontal or slightly inclined position.
6. Device according to one of claims 1 to 5, in which the elements (1, 4, 7) for connecting the bag (10) are sterile or can beg sterilized, and can preferably be attached to the container (11) or its cover (13) by means of a removable locking device (14).
7. Device according to one of claims 1 to 7, in which the medium is a degassed liquid) in particular water.
8. Non-pulsating pump unit containing a delivery device according to one of claims 1 to 7, having a first container (11) and at least a second container (11') provided with a third set of elements (1', 4', 7') for connecting another bag, intended to receive or deliver the liquid and to deliver or receive it non-pulsating to or from the external processing chamber (16) through the third set of elements, whereby the interior of the second container (11') is connected by means of the second element (20) to the pump (21) or by means of another element to another pump, intended to deliver a sterile or non-sterile medium, which is not in contact with the liquid, to the interior of the second container (11').
9. Pump unit according to claim 8, containing a single pump (21), which optionally can be connected to the inside of the first or the second container by means of the second element (20).
10. Pump unit according to claim 9, in which the medium can be introduced into the first and/or second or all containers through a volumetric flow regulator in a time constant or program controlled fashion.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CH75298 | 1998-03-31 | ||
| CH752/98 | 1998-03-31 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2267644A1 true CA2267644A1 (en) | 1999-09-30 |
Family
ID=4194374
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002267644A Abandoned CA2267644A1 (en) | 1998-03-31 | 1999-03-31 | Apparatus for conveying a sterile liquid pulsation-free from or to a sterile container |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP0947207B1 (en) |
| AT (1) | ATE260684T1 (en) |
| CA (1) | CA2267644A1 (en) |
| DE (1) | DE59908681D1 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2844705B1 (en) * | 2002-09-25 | 2005-09-16 | Medex Sa | SOFT POUCH AND INJECTION DEVICE THEREFOR |
| DE102009017918A1 (en) | 2009-04-17 | 2010-12-16 | Fachhochschule Jena | Method and device for pulsation-free volumetric delivery of fluids and suspensions |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2842123A (en) * | 1956-05-25 | 1958-07-08 | Le Roy M Rundhaug | Pressurized transfusion apparatus |
| US3199511A (en) * | 1961-04-26 | 1965-08-10 | Kulick George | Apparatus for precise administration of parenteral fluids |
| US4332246A (en) * | 1980-06-30 | 1982-06-01 | Staodynamics, Inc. | Positive displacement intravenous infusion pump device and method |
| FR2592306A1 (en) * | 1985-12-30 | 1987-07-03 | Couegnas Jacques | Perfusion apparatus with adjustable flow rate causing no change in the perfused liquid |
| ES2004595A6 (en) * | 1987-04-09 | 1989-01-16 | Ruano Marco Miguel | Volumetric pump for parenteral perfusion. |
| EP0721360A1 (en) * | 1992-11-09 | 1996-07-17 | SIPIN, Anatole J. | Controlled fluid transfer system |
| DE69318988T2 (en) * | 1993-06-01 | 1999-01-28 | Guignard Mireille | DEVICE FOR INPUTING A LIQUID UNDER A PARTICULAR PRESSURE IN A BODY CAVE OF A HUMAN OR ANIMAL |
| FR2717085B1 (en) * | 1994-03-11 | 1996-07-12 | Medex Sa | Method for injecting medical liquid and its implementation device. |
-
1999
- 1999-03-30 DE DE59908681T patent/DE59908681D1/en not_active Expired - Fee Related
- 1999-03-30 EP EP99810270A patent/EP0947207B1/en not_active Expired - Lifetime
- 1999-03-30 AT AT99810270T patent/ATE260684T1/en not_active IP Right Cessation
- 1999-03-31 CA CA002267644A patent/CA2267644A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| DE59908681D1 (en) | 2004-04-08 |
| EP0947207A2 (en) | 1999-10-06 |
| EP0947207B1 (en) | 2004-03-03 |
| ATE260684T1 (en) | 2004-03-15 |
| EP0947207A3 (en) | 2000-01-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |