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Title:
BAG AND METHOD FOR INTRAVENOUS OR INTRACORPOREAL ADMINISTRATION OF MEDICAL SOLUTION TO A PATIENT
Document Type and Number:
WIPO Patent Application WO/2013/055283
Kind Code:
A1
Abstract:
The invention relates to intravenous or intracorporeal administration of medical solutions to a patient. In particular it comprises a bag comprising a container (1) having an inlet port (2) and an outlet port (4). The bab is suitable made of a flexible material such as plastic. There are components of a medical solution in concentrated or dry form provided aseptically inside the container. Furthermore, there is provided a sterile filter (3) in said inlet port (2). In a preferred embodiment, the components in the container form a peritoneal dialysis solution when dissolved in water. The invention also relates to a method of intravenous or intracorporeal administration of medical solutions to a patient.

Inventors:
HARALDSSON BOERJE (SE)
Application Number:
PCT/SE2012/051084
Publication Date:
April 18, 2013
Filing Date:
October 10, 2012
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
SOINIAL AB (SE)
International Classes:
A61J1/14; A61M1/14; A61M1/28
Domestic Patent References:
WO1998017333A21998-04-30
WO2007028056A22007-03-08
WO2002102722A12002-12-27
Foreign References:
US6274103B12001-08-14
US5259954A1993-11-09
Other References:
See also references of EP 2765971A4
Attorney, Agent or Firm:
BRANN AB et al. (S- Stockholm, SE)
Download PDF:
Claims:
CLAIMS:

1. A bag for intravenous or intracorporeal administration of medical solutions to a patient, comprising a container (1) having an inlet port (2) and an outlet port (4), characterized in that there are components of a medical solution in concentrated or dry form provided aseptically inside the container, and in that

there is provided a sterile filter in said inlet port.

2. The bag according to claim 1, wherein the components form a peritoneal dialysis solution when dissolved in water. 3. The bag according to claim 1, wherein the components comprise salt(s), sugar(s) and other excipients.

4. The bag according to claim 1, wherein the components comprise nutrients forming a nutrient solution, or compounds forming an isotonic solution, when water is added.

5. The bag according to claim 1, wherein said inlet port is provided with a connector for connecting to a water feeding system. 6. The bag according to claim 5, wherein the connector is of the Luer lock type.

7. The bag according to any preceding claim, wherein the components are provided in the container at a dry matter content of more than 50% dry matter, preferably more than 70%, even more preferred 90%, and most preferred 100% dry matter.

8. The bag according to any preceding claim, containing glucose monohydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride-hexa hydrate, sodium bicarbonate, sodium lactate. 9. The bag according to claim 8, wherein the sodium bicarbonate is replaced by lactate.

10. The bag according to any preceding claim, wherein the container comprises two or more compartments, each housing a selection of components, each compartment can be opened separately to selectively dissolve the components.

11. The bag according to claim 10, wherein two or more compartments contain different amounts of glucose, such that different concentrations of glucose are obtainable. 12. A method of intravenous or intracorporeal administration of medical solutions to a patient, comprising

providing a container, housing the components of said medical solution in dry or concentrated form, at the location where the administration is to be performed;

supplying non-sterile water to the container through a sterile filter attached to the container, so as to provide a medical solution in a form that can be administered to the patient;

attaching an outlet of said container to a system for administration of medical solution to the patient;

letting the medical solution flow from the container to the patient.

13. The method according to claim 12, wherein water is supplied at the time of use.

14. The method according to claim 12 or 13, wherein the components in the container form a peritoneal dialysis liquid when water is added.

15. The method according to claim 12 or 13, wherein the components comprise nutrients forming a nutrient solution, or compounds forming an isotonic solution, when water is added.

Description:
BAG AND METHOD FOR INTRAVENOUS OR INTRACORPOREAL ADMINISTRATION OF MEDICAL

SOLUTION TO A PATIENT

Field of the Invention

The present invention relates generally to the area of administration of medical solutions, in particular peritoneal dialysis. More specifically it relates to new bags for medical solutions, such as peritoneal dialysis solutions, for reducing costs of e.g. dialysis in all parts of the world.

BACKGROUND OF THE INVENTION

Description of the related art

People suffering from reduced kidney function may have a hard time filtering waste products from their own body. When the waste products build up in the body, the persons affected become sick and require dialysis, a medical/ mechanical substitute for the normal function of the kidneys, which cleanses the body from waste products.

1. Dialysis

There are two main types of dialysis, hemodialysis and peritoneal dialysis, which remove waste solutes and excess water from the blood in different ways.

Hemodialysis (HD) removes waste solutes and water by circulating blood outside the body through an external filter, called a dialyzer, which contains a

semipermeable membrane. HD requires dialysis equipment and trained personnel, in contrast to peritoneal dialysis, which is performed by the patient himself, or persons related to the patient. In peritoneal dialysis (PD) waste solutes and water are removed from the blood inside the body using the peritoneal membrane of the peritoneum as a natural semipermeable membrane. Waste solutes and excess water move from the blood, across the peritoneal membrane, and into the abdominal cavity and dialysis solution, which has a composition similar to the fluid portion of blood. In PD, a sterile solution (dialysis solution) flows through the catheter into the abdomen. The solution stays in the abdomen for a prescribed period of time, known as dwell time. During this dwell time ("the dwell"), waste solutes, electrolytes and biochemical diffuse across the walls of tiny blood vessels (capillaries) in the lining of the abdominal cavity (peritoneum) between blood and the dialysis solution. The solution contains sugar (glucose) that draws extra fluid through the capillaries in the peritoneum from blood to the abdominal cavity by the increased crystalloid osmotic pressure caused by glucose. When the dwell time is over, the dialysate (used dialysis solution), along with waste products and any excess fluid drawn from the blood, drains into a sterile collection bag. The process of filling and draining the abdomen is called an "exchange". Different methods of PD have different schedules of daily exchanges. The two main schedules are continuous ambulatory peritoneal dialysis (CAPD) and automatic peritoneal dialysis (APD), also called continuous cycling peritoneal dialysis (CCPD). Some people use a combination of both methods.

Although the PD technique, as well as the outpatient haemodialysis therapy (or just haemodialysis), is a blood purifying process, it is endogenous and therefore it occurs inside the patient's body without withdrawing blood. It is based on the peritoneum membrane's extensive vascularization. In its most basic application, this technique is simple: a certain quantity of dialysis solution (usually 2 liters in an adult) is introduced into the abdominal cavity through a permanent catheter, creating conditions for a slow balance, using the same mechanisms as for the outpatient haemodialysis. The solution is thereafter removed (with the toxic substances accumulated in it) and the process repeats itself. This process is called "exchange", since the patient removes the solution by connecting an empty bag to the catheter and then fills the peritoneal cavity through another bag with fresh solution. The name of this method is Continuous Ambulatory Peritoneal Dialysis (CAPD).

When using CAPD, the patient fills the abdomen with dialysis solution and later drains the fluid. Gravity moves the fluid through the tube and into and out of the belly. Each exchange includes filling the abdomen with dialysate fluid, letting the fluid dwell in the abdomen, and then draining the fluid. The patient may need three to four exchanges during the day and one with a longer dwell time during sleep. The patient can do the exchanges at home, work or any clean place. The patient is free to go about in hers/his normal activities while the dialysis solution dwells in the abdomen between exchanges.

A variant of this treatment is carried out through the night, while the patient is asleep, with an appropriate automatic machine called Cycler. This technique is called Automatic Peritoneal Dialysis (APD), Cyclic Peritoneal Dialysis (CCPD) or Tidal Peritoneal Dialysis (TPD). With APD, a machine performs three to ten exchanges at night while the patient is asleep. The cycler automatically fills the abdomen with dialysis solution, allows it to dwell there, and then drains it to a sterile drainage bag that the patient empties in the morning. If possible, the drainage can directly be led through a tube to the toilet. The APD gives the patient more flexibility during the day, but he or she must remain attached to the machine for 8 to 12 hours at night. Some patients only require dialysis during the night and the Cycler ends its session with a complete drain. In other patients, the machine stops after a complete fill of the abdominal cavity with dialysis solution, and the dwell time can last for the entire day, or for 4-8 hours. Normally, the patient is not connected to the machine during the day.

Rather than performing manual peritoneal dialysis exchanges several times throughout the day, a patient can do automated peritoneal dialysis while they sleep. Automated peritoneal dialysis is done using a machine that fills the peritoneal cavity with fresh dialysis solution, also called PD fluid or PD solution, and after a specified dwell time, drains the solution with waste substances and excess fluid of the body, and then fills the peritoneal cavity with new dialysis solution. The average treatment time for automated peritoneal dialysis is 9 hours at night during sleep.

2. Problems in the prior art

Today less than 40% of patients with dialysis dependent kidney disease are actually treated. This is true particularly for patients in need of dialysis for shorter periods due to acute kidney failure. One of the major reasons for the under- treatment is the high cost associated with dialysis, including the rather "simple" peritoneal dialysis (PD). The major cost factor of PD is the dialysis solution, the liquid in the plastic bags to be used for the dialysis process. The amount of dialysis solution may be, for example using CAPD, 2 liters at the time, 4 times a day, 7 days a week, that needs to be manufactured, transported and distributed. A PD patient uses between 8 and 20 liters of dialysate per day, i.e. three to seven tons of solution each year. All these heavy bags must be transported into the home of the patient where it occupies a substantial space with deliveries every second week. The patient must also lift substantial weights during a normal day and patients are most often elderly with low muscle strength. The cost of these liquids is approximately

$35,000-40,000 USD per year for chronic treatment. Even more common is that the patients need acute dialysis for a short period of time, such as 2-6 weeks, often due to dehydration caused by diarrhoea or high fevers (malaria), or low blood pressure by other causes (trauma, thirst, etc.). Dialysis may reverse acute kidney failure and cure the patient. Today many people in poor countries die of a simple stomach flu, sometimes due to the lack of dialysis.

PD treatments require substantial volumes of dialysate, which needs to be transported to the end user. Since these transports are very costly, a way to minimize the transportation cost is desirable. Of course the transport is also an environmental problem. Also, warmer or freezing temperatures during transport and storage is a further problem with such bags, which can severely influence the quality of the product.

In many parts of the world, dialysis is a utopic luxury for the poor people in need of such treatment. Since the shipping and transportation costs of the dialysis solution are a substantial cost preventing dialysis for patients in poor countries, a reduction of such transportations costs may fulfil the ambition which is "dialysis for all" in need. 3. The closest related art

Patent application WO9705852 describes a multi-compartment bag containing a sterile medical solution. The bag is able to contain three different glucose concentrations depending on which compartments are connected, by breaking pins in a connection tube for each compartment. By separating the glucose and the other components, such as the electrolyte solution, the storage stability is increased and the formation of toxic products minimized. However, the patent application WO9705852 does not mention water-free content or the use of solids or concentrated liquids. Further, it does not mention a sterile filter port for adding local water, and it does not mention reduced costs (rather the cost of production is higher).

Patent applications WO 1 1073274 and US2004243094 describe containers for dialysis, containing salt or glucose concentrates in the forms of e.g. powders or slurries.

WO 1 1073274 describes a multi chamber dialysis bag with concentrates separated in different chambers for greater storage stability, and a method for dissolving said concentrates by adding water to one chamber first, and then breaching the seal between the chambers. US2004243094 defines a dialysis container with a salt concentrate, where the inlet and outlet have been arranged to maximize dissolving of the salt when adding water. These inlets and outlets have filters, however these filters do not provide sterile water, and the use of local water is not mentioned. None of these patents mentions reduced transportation costs due to lack of water in the bags, or the possibility of using a sterile filter to be able to fill the bags with other than sterile water just before dialysis. The patents do not mention reduced costs. Both of these patents require separate transport of sterile water. Patents WO 1 1073274 and US2004243094 could use local production of sterile water, but it would then require sterile connectors to transfer the sterile fluid into the PD bags with dry powder, i.e. by filling 2 liters of sterile water into a separate plastic bag and then injecting the water into the PD bag with dry powder.

Patent application EP1716875 describes a container with concentrated dialysis solutions, for cheaper transportation costs. The new design of a transport arrangement comprises a plastic can with a highly concentrated fluid, two boxes with a dry component positioned at both sides of the can and a flat bag with another dry component on top of the three containers. This application does not mention ports for sterile filters as a mean to utilize local water. Therefore, patent application EP1716875, as the two patents above, requires sterile water to be transported together with the concentrated solutions, or the local production of sterile water that needs to be collected into a separate bag and injected into the concentrated solution to obtain adequate dialysis fluid. Patent application

EP1716875 may reduce transport costs (if there is local production of sterile water in a separate system), but the cost reduction is likely to be moderate. This device prior invention is more complicated than the present invention and it does not solve the problem of filling the bags at the location of the end user at a low cost, since it does not contain a sterile filter or any other embodiment that makes the use of local water possible. Hence, the dialysis would still be too expensive for poor people in need.

SUMMARY OF THE INVENTION

In view of the drawbacks associated with the prior art, the object of the present invention is to provide for simplified and cheaper administration of medical solutions in general and peritoneal dialysis liquids in particular.

This object is achieved with a new design of a bag for medical solutions, and in particular a peritoneal dialysis bag that will reduce costs for dialysis. The bag is prefilled with concentrated or dry glucose and various salts, but lack water, or most of the water. Due to this feature, the cost for shipping and transporting the bags is greatly reduced, thus an object of the invention is to reduce the cost for

transporting dialysis bags from the factory to the end user.

An advantage with the new bag is that the cost of refilling the dialysis bag is reduced, due to a sterile filter provided in the bag local non-sterile water may be used, and the refilling may be conducted in a non-sterile environment.

Furthermore, the thickness of the bag is reduced, and thereby the cost of the plastic bag production is also reduced due to lower demands during transport of water-free bags. Another advantage is that it is possible to provide low cost dialysis to people in regions that cannot afford it today.

Still another advantage is that the invention allows simple on-line production of peritoneal dialysis solution for APD that will improve quality and simplify the procedure and the workload for the patient.

In a second aspect of the invention there is also provided a method for peritoneal dialysis, comprising the employment of the new bag.

Other objects and advantages of the present invention will become obvious to the reader, and it is intended that these objects and advantages lie within the scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

Figure 1 is a plan view showing the basic design of the plastic bag of this invention;

Figure 2 illustrates the use of the new invention in a single bag fashion;

Figure 3 illustrates the use of the new invention in a double bag Y-set fashion; and

Figure 4 is a schematic illustration showing the on-line PD cycler based on the invention.

DETAILED DESCRIPTION OF THE INVENTION AND PREFERRED EMBODIMENTS THEREOF

The general purpose of the invention is to provide means and methods for intracorporeal or intravenous administration of medical solutions at a low cost. An important application is low cost dialysis, in particular peritoneal dialysis (PD), in a non-sterile environment, such as in the home of the patient. The patient must still connect and disconnect to the PD catheter using a sterile protocol without contaminating the connector in order to avoid peritonitis (infection in the abdominal cavity). The dialysis may be carried out in a sterile environment by trained personnel if preferred, but the invention makes such a sterile environment and trained personnel unnecessary, since the dialysis of the invention may be carried out by the patient himself in the home of the patient.

The bags are prefilled with concentrated or dry chemicals, such as glucose and salts, but lack all or most of the water, and will form a medical solution when water is added.

Preferably the chemicals are in dry form. By "dry" we mean in the form of a powder or granules, i.e. solid particles that do not stick to each other as paste or the like. Salts and other compounds containing hydration water or crystal water are regarded as dry as long as they behave like powder or granulates. "Powder" may refer to a material composed of very fine particles that are not cemented together.

Due to this feature, the lesser weight and volume of the bags, the cost for shipping and transporting the bags is greatly reduced. The reduced transporting weights also have environmental advantages besides the cost benefits.

For the purposes of this invention the term "medical solution" is to be construed broadly, and can encompass dialysis fluid, nutrition solutions, blood replacement liquid and isotonic liquid just to mention a few examples, thus, both intracorporeal and intravenous administration lies within the scope of use of the new bag.

Due to a sterile filter provided in the bag, local non-sterile water may be used, and the refilling may be conducted in a non-sterile environment by the patient himself. The filter is typically a single-use sterile filter through which tap water or deionized water may be added to the dialysis bag before use. The cost for refilling the bags with local non-sterilized water at the site of dialysis by the patient himself greatly reduces the costs compared to refilling the bags in a sterile environment by trained personnel in the factory or in a hospital.

This is obtained both by the reduced cost for shipping and transporting to the location of the end user and the reduced cost for refilling the bags at the location of the end user. The price of the raw materials used for the manufacture of PD-solutions stands in sharp contrast to the giant amounts the dialysis treatments cost. A bag for PD-treatment contains glucose, saline, lactate, magnesium, calcium and eventually bicarbonate. To that is added plastic packaging, plastic tubes and water. Lowering the costs of transportation will thus markedly reduce the costs for PD.

Through the use of the invention, people in third world countries who cannot afford dialysis today may be able to get the treatment they require, at least for acute renal failure and possibly even for patients with chronic disease. To solve the problem discussed in connection with the prior art of high transportation costs, the present invention therefore provides new dialysis bags, which makes it possible to transport the bags without water present as a solvent, i.e.. only containing dry salts, glucose etc.. This greatly reduces the weight and volume of the dialysate bags, thus minimizing the transportations cost from the factory to the location of the end user. Another costly problem occurring when shipping bags with dry content is the cost for refilling the bags with water. If using existing bags, this would have to be done in a sterile environment by trained personnel using sterile water. This sterile water could either be manufactured at the end location, but could also be shipped separately, increasing the transportation costs. By incorporating a single-use sterile filter into the dialysis bags, the patient himself is able to fill the bags at home using regular tap water or deionized water, which further reduces the costs. Also, less robust plastic bags can be used when they are not to be transported filled with water; this will further reduce costs.

The invention is based on a new concept where basically the water is absent from the PD bag until use, and the PD solution is formulated at the location where it is to be used, and using local water for the final preparation of the solution. Thus, a new kind of bag has salt, sugars, etc. distributed aseptically (sterile) inside the bag. Furthermore, the bag has a small sterile filter attached in the inlet so that local water can be used for supplying the liquid phase of the product on site.

Based on the new invention, a new cycler technique has been developped that will facilitate life for the patient and improve treatment. Thus, for patients on APD, the cycler machine can be connected to the normal cold tap water pipes. PD bags designed according to the new invention, i.e. containing dry powder of glucose and electrolytes, are connected to the machine. The machine will then start filtering water a few hours before start of treatment and filling the PD bags with sterile water. After the dialysis, the spent dialysate can be diverted to the toilet. Thus, the patient will only need to handle the low weight bags with dry substance instead of the standard 5 liter bags used for APD today.

A new dialysis solution bag is thus proposed, in one embodiment of the invention, containing salts and glucose in one chamber, and a sterile filter. In a more advanced embodiment, a multi-compartment bag is proposed, containing salts in one chamber, glucose in different concentrations in the other chambers, and a sterile filter for adding local water to the bag. The same kind of bag could also be used, for example, for intravenous (iv) purposes in non-sterile environments, to deliver replacement liquids for blood and liquid losses under field conditions, such as disaster or war situations where it is desired to be able to keep supplies at minimal weight.

All solutions for dialysis or for iv applications undergo heat-sterilization. It is a simple technique with some drawbacks. When glucose solutions are heated, a number of different aldehydes are formed, such as formalin, glutaraldehyde etc. These substances are non-physiological and unwanted bi-products, which may harm blood vessels and tissues. There are two ways to minimize or prevent the formation of aldehydes: sterile filtering or heat-sterilized glucose using a pH under 3, i.e. in a separate compartment of the packaging. Today the latter method is used in PD-bags with two or three compartments. The suggested PD bag with dry powder of glucose and various salts, or a bag containing salts but no glucose, can be sterilized by heat or by irradiation without the formation of aldehydes or other bi- products.

The present dialysis bag uses a bag without any solution i.e. with dry components only, or with a concentrate. The dry matter content is more than 50% dry matter, preferably more than 70%, even more preferred 90%, and most preferred 100% dry matter.

One could use two or three compartments to allow for swift alterations of the concentration of glucose or any of the electrolytes.

A new dialysis bag is thus proposed, containing glucose in different concentrations and salts, and a sterile filter for adding local water to the bag.

Figure 1 is a plan view showing the basic design of an embodiment of a peritoneal dialysis bag which can be used for dialysis or for intravenous infusions of sterile solutions. The figure illustrates the main components of the new peritoneal dialysis bag. Thus, it comprises a container 1 , suitably made of flexible plastic material, which is prefilled with glucose and various salts from the factory, but not filled with water. The container has an inlet 2 and an outlet 4. The inlet 2 is equipped with a sterile filter 3 allowing for addition of tap water via a water line 5 to the container prior to use in the home of the patient, or in a hospital. The sterile filter can be a of the commercial type filter 3, or it can be integrated into the PD bag to increase its surface area and hence increase flow rate. Finally, there is a tube segment 4, connectable to a patient line 7 that allows the well-mixed fluid to flow into the patient. The sterile filter port is provided during production of the bag.

Figure 2 illustrates the use of a single bag. The water-free container 1 is easily transported to the patient, where it is filled with tap water from the household water supply via a water line 5 or manually pumped using a simple device from a storage container (not shown) to the plastic bag container 1. Once the bag is filled 6, the water line 5 is disconnected and the well-mixed solution fills the patient through the patient line 7. The pressure gradient that drives fluid into the abdominal cavity is the hydrostatic pressure achieved by hanging the PD bag 1 - 1 b meter above the midsection of the patient 8. The empty bag is rolled and worn for 4- 6 hours when the abdominal cavity is drained back through the patient line to the empty PD bag. The single bag is disconnected and the content is flushed into the toilet. The procedure is repeated with a new single bag.

Figure 3 shows the use of the new invention in a double bag Y-set fashion. As for Figure 2, the water-free bag is easily transported to the patient, where it is filled with tap water from the household water supply or manually pumped from a water storage container using a simple device, to the plastic dialysis bag chamber. The rest of the procedure does not differ from the standard procedure today in

CAPD. Once the bag is filled 6, the water line is disconnected and the well-mixed solution is elevated. The disconnectable portion of the Y-set 1 1 is connected to the patient and the procedure starts with a drain through the drain line 9 to the empty drain bag 10. After the drain, the drain line 9 is clamped and PD solution fills the patient through the patient line 7 which now is opened. After the fill, the entire Y- set is dis-connected from the patient and a single use cap is placed on the connector. The patient can now move without carrying the plastic bags.

The daily consumption of peritoneal dialysis solutions for a patient on CAPD treatment is normally 2 liters of liquid used four times daily. For comparison, a standard PD bag pre filled with solutions has a weight of 4 x 2.3 kg = 9.2 kg per day for a normal daily use. The novel PD bags prefilled with glucose and salts, but without water weighs 4 x 0.3 kg = 1.2 kg per day, i.e. the transport weight and costs are reduced by a factor of 9, and consequently so is the workload required by the patient each day to perform the dialysis.

Figure 4 is a schematic graph showing the on-line PD cycler based on the invention. The new water-free PD bags 1 are connected to the cycler through the water lines 14 attached to the sterile filter ports and through the PD solution lines 15. Household tap water is connected to the PD cycler 16 via water line 5. The machine starts with filling the PD bags 1 with water. The patient is then filled through the patient line 17 and the dialysate is drained through the same line 17 to the machine and goes directly to the toilet through the spent dialysate line 18. The patient line could well be a double lumen tube with one lumen for fresh fill solution and the other for spent dialysate. The patient does not need to carry any water. Sterile water is added to the bags, mixed with glucose and various salts, and the spent dialysate is drained to the toilet. This is much easier than the current status for the peritoneal dialysis field.

In one embodiment a multi-compartment bag containing salts in one chamber, glucose in different concentrations in the other chambers, and a sterile filter for adding local water to the bag is used. The same kind of bag could also be used for example in iv solutions, for hydration of patients suffering from blood and fluid losses under field conditions, such as disaster or war situations where you want to be able to keep supplies at minimal weight. The same principle may be used to manufacture solutions for iv purposes, such as saline solutions, glucose solutions or Ringer.

The new kind of bag has salt, sugars etc. distributed sterile inside the bag, plus an extra port where a small sterile filter is attached so that local water can be used for supplying the liquid phase of the product on site. The bag is equipped with two ports - one supplied with a sterile filter e.g. with a Luer-Lock type (Luer-Lok is a trademark belonging to Becton Dickinson) mounting, and one consisting of a longer tube with a standard coupling for connecting to a PD-catheter extension.

The bags may be manufactured as single bags or double bags (Y-set). A single bag is a very simple, reliable and cheap system containing a bag with dialysate, a tube and a connector to the peritoneal catheter. The single bag is folded and carried during the dwell and the same bag is used to collect the drained dialysate. With a single bag no protective cap is needed for coupling since there is always a connected bag. Double bags have one bag containing fresh dialysate and a second empty bag for used dialysate, coupled with a Y-coupling. The great advantage of a double bag system is that the patient can disconnect the system after filling the abdomen with fresh PD fluid. After the dwell, a new Y-set is connected, used dialysate is collected in one bag, fresh dialysis fluid is filled into the patient and the system is disconnected again.

The weight of a dialysate bag with liquid is approximately 2500 g, which means about 10 kg per day. If the bags are manufactured without water, the demands on the quality of the bags diminish, and the weight may be reduced, for example to 300 g per bag, i.e. 1.2 kg a day. The present invention gives rise to many advantages, such as reduced costs during manufacturing, reduced transportation costs and less heavy lifting for the patient. By using a sterile filter containing a membrane that can bind endotoxins and prevents passage of bacteria and virus, the demands on the original quality of the water is reduced. The idea is that the available local water should be used. The water may be deionized, but it is not necessary. The amounts of minerals in the water is acceptable in PD, since only relatively small amounts of water passes the body, compared to HD where the water needs to be completely deionized. If the local water is of very poor quality, a pre -filtration using a simple filter could be

performed.

The distribution of a single use filter in the bag ensures that the bag is not contaminated with bacteria, virus or endotoxins. To fill the bag with 2 liters of water hydrostatic pressure is used. The equipment used for filling the bags with water may be used several times. Using commercially available filters, a water pressure of 2 bars is needed to fill the bag in 10 minutes. The filters endure a maximum of 10 bars. Most manufacturers of dialysis products have in house world-leading expertise in dialysis filter technology. It is should be possible to increase the water flow rate by using a different membrane composition, or simply by increasing the diameter of the filter. In areas with pure tap water, the equipment may be coupled directly to the water tap. In other areas, a hand driven pump may be used to introduce water into the bag. The volume of the bag may easily be regulated using a scale. After the water has been added, the entry port is closed using a clamp. The port can also be used if antibiotics, heparin or other drugs need to be given. The content of the bag is mixed well and heated to 37 degrees Celsius using a hot plate or such. The heating may also be performed during the filling of the bag, to speed up the process. When the bag is filled, mixed and heated, the dialysis can begin.

The principle of adding water just before dialysis makes it possible to develop a new and better PD -machine or PD cycler. Today several problems arise in treatments with a PD-cycler. These problems include storage of large quantities of PD-solution, heavy transports and quite often relatively low serum potassium. By manufacturing bags containing glucose and salts, with or without potassium, and without water, these problems may be solved. The new PD-apparatus could be coupled to a water tap and add exact volumes to 5 liter PD-bags, which would remarkably enhance the quality in APD treatments. Also, the drain can be directed to the toilet using a drainage tube reducing the workload for the patient. Hence, a new dialysis apparatus for PD, which has medical benefits and admits on-line preparations in a simple and secure way, may be developed.

Different variants of bags may be produced, for example one bag for each glucose level is used (15, 25 or 40 g/1). Alternatively, one could produce a multi compartment bag, for example with three chambers, thus only needing to

manufacture and store one bag. In the first chamber (C) are all the salts, in the second (A) 30 g glucose (for a 21 bag), and in the third (B) 50 g glucose. By opening chamber A, B or A+B the three glucose concentrations are achieved. This principle is used commercially today in a system called Gambrosol Trio.

Even when it comes to glucose or saline solutions for iv use, transport is a problem. Similar principles as described above may be used for all solutions containing glucose, and/or salts, for example 5% glucose with or without 80 mM NaCl, 10 % glucose, 0.9 % physiological saline, or Ringer-acetate. These products will also benefit from reduced costs for production and transport in areas with less advanced infrastructure or regions hit by earthquakes or other natural or human disasters. EXAMPLES

The present dialysis bag has components of a dialysis fluid such as salt, sugars etc. distributed aseptically inside the bag. Furthermore, the bag is provided with a small sterile filter which is attached in the inlet so that local water can be used for supplying the liquid phase of the product on site. The bag will be equipped with two ports; one supplied with a sterile filter e.g. with a Luer-Lock connector, and one consisting of a longer tube with a standard coupling for connecting to a PD catheter extension.

A 2 -liter bag is in one preferred embodiment filled with the following substances in dry form: Glucose monohydrate 30. Og (alternatively 50 g or 85 g), sodium chloride, 10.76 g, calcium chloride dihydrate 0.368 g, magnesium chloride- hexa hydrate 0.102 g, sodium bicarbonate 4.20 g, sodium lactate 3.36 g (eventually the bicarbonate may be fully exchanged by lactate). When 2 liters of water is added, it will give rise to the following concentrations; Glucose 75.5 mmol/1 (alternatively 126 mM or 214 mM), Na + 132 mM, Ca ++ 1.25 mM, Mg ++ 0.25 mM, C1 95 mM, HC0 3 - 25 mM, lactate 15 mM.

Examples of sterile "on-line" filters for filtering a few liters of water: diameter 33 mm, pore size 0.45 um, membrane type polysulfone, which also binds eventual endotoxins. An example of such a sterile filter is Millex GP (0.22um, 33 mm diameter membrane type PES), obtainable from Merck Millipore, which gives water flow of 200 ml/min at 2.1 bars of water pressure at 25 degrees Celsius. This means that a 2-liter PD-bag will be filled in 10 minutes. While the invention has been described with reference to specific embodiments, it will be appreciated that numerous variations, modifications, and embodiments are possible, and accordingly, all such variations, modifications, and embodiments are to be regarded as being within the spirit and scope of the invention.