Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • 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
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1654—Dialysates therefor
  • A61M1/1656—Apparatus for preparing dialysates
  • A61M1/1666—Apparatus for preparing dialysates by dissolving solids
• • 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
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1654—Dialysates therefor
  • A61M1/1656—Apparatus for preparing dialysates
  • A61M1/1668—Details of containers
  • A61M1/167—Flexible packaging for solid concentrates
• • 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
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1654—Dialysates therefor
  • A61M1/1656—Apparatus for preparing dialysates
  • A61M1/1672—Apparatus for preparing dialysates using membrane filters, e.g. for sterilising the dialysate
• • 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
  • A61M1/287—Dialysates therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2079—Filtering means
  • A61J1/2086—Filtering means for fluid filtration

Definitions

• 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.
• 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 removes waste solutes and water by circulating blood outside the body through an external filter, called a dialyzer, which contains a
• peritoneal dialysis 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.
• 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.
• 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.
• the dialysate used dialysis solution
• the dialysate used dialysis solution
• 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).
• the PD technique 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).
• CID Continuous Ambulatory Peritoneal Dialysis
• the patient 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).
• APD Automatic Peritoneal Dialysis
• CCPD Cyclic Peritoneal Dialysis
• TPD Tidal Peritoneal Dialysis
• APD Automatic Peritoneal Dialysis
• CCPD Cyclic Peritoneal Dialysis
• TPD Tidal Peritoneal Dialysis
• 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.
• 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
• 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.
• 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 is 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• Figure 4 is a schematic illustration showing the on-line PD cycler based on the invention.
• 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.
• PD peritoneal dialysis
• 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.
• concentrated or dry chemicals such as glucose and salts
• the chemicals are in dry form.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• a new kind of bag has salt, sugars, etc. distributed aseptically (sterile) inside the bag.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• FIG. 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.
• 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.
• 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
• 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.
• the drain line 9 is clamped and PD solution fills the patient through the patient line 7 which now is opened.
• 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.
• FIG. 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.
• 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.
• 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
• 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.
• bags may be produced, for example one bag for each glucose level is used (15, 25 or 40 g/1).
• one bag for each glucose level is used (15, 25 or 40 g/1).
• 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).
• 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.

Landscapes

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

Applications Claiming Priority (2)

Publications (2)

Family

ID=48082170

Family Applications (1)

Country Status (2)

Cited By (2)

Families Citing this family (4)

Family Cites Families (8)

• 2012
  • 2012-10-10 EP EP12839809.6A patent/EP2765971A4/de not_active Withdrawn
  • 2012-10-10 WO PCT/SE2012/051084 patent/WO2013055283A1/en active Application Filing

Also Published As

Similar Documents

Legal Events