US20070003637A1 - Bicarbonate-based solutions for dialysis therapies - Google Patents
Bicarbonate-based solutions for dialysis therapies Download PDFInfo
- Publication number
- US20070003637A1 US20070003637A1 US11/531,121 US53112106A US2007003637A1 US 20070003637 A1 US20070003637 A1 US 20070003637A1 US 53112106 A US53112106 A US 53112106A US 2007003637 A1 US2007003637 A1 US 2007003637A1
- Authority
- US
- United States
- Prior art keywords
- mmol
- solution
- bicarbonate
- dialysis
- chamber
- 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
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
Definitions
- the present invention relates generally to medical treatments. More specifically, the present invention relates to bicarbonate-based solutions for use during dialysis therapies, such as continuous renal replacement therapies.
- a variety of different medical treatments are known and used to treat critically ill patients for acute renal failure (ARF) which is typically associated with multiple organ failure syndrome in intensive care settings.
- ARF acute renal failure
- traditional dialysis therapies such as hemodialysis and peritoneal dialysis, are commonly used to treat ARF.
- CRRT in general, is a slow and continuous therapy that does not include rapid shifts in blood volume and electrolyte concentration due to the removal of metabolic products from blood as compared to traditional forms of dialysis therapy, such as hemodialysis.
- continuous renal replacement therapies include continuous arteriovenous hemofiltration, continuous arteriovenous hemodiafiltration, continuous venovenous hemofiltration, continuous venovenous hemodiafiltration, slow continuous ultrafiltration and continuous ultrafiltration periodic intermittent hemodialysis.
- CRRT is a convective blood cleansing technique that utilizes a patient's blood pressure as the primary driving force for ultrafiltration.
- blood typically flows through a hemofilter such that a transmembrane pressure gradient between the blood compartment and the ultrafiltrate compartment causes plasma water to be filtered across the highly permeable membrane. As the water crosses the membrane, it can convect small and large molecules across the membrane and thus cleanse the blood.
- substitution fluid can be infused intravenously either into the arterial blood line leading to the hemofilter (predilution) or into the venous blood line leaving the hemofilter (post dilution).
- lactate-based solutions typically, commercially available replacement fluids are lactate-based solutions.
- physiological buffer bicarbonate is preferred over lactate in patients with multiple organ failure which is typically associated with ARF.
- the metabolic conversion of lactate to bicarbonate is not required prior to metabolic action thus eliminating undesirable effects due to the conversion process of lactate to bicarbonate.
- bicarbonate it is common practice among intensive care physicians to manually prepare solutions buffered with bicarbonate extemporaneously. This is typically carried out by adding the prepared bicarbonate solution to an existing sterile solution to form the bicarbonate-based solution prior to administration to the patient. For example, it is known to add bicarbonate to an acidic electrolyte concentrate solution which is in direct contact with administration tubing connected to the patient prior to administration thereof to the patient. It is also common practice to manually inject other electrolytes, such as potassium chloride, directly and separately into the bicarbonate-based solution prior to administration.
- electrolytes such as potassium chloride
- the present invention provides improved bicarbonate containing solutions that can be effectively administered during dialysis therapy, such as continuous renal replacement therapy.
- the bicarbonate containing solution of the present invention includes at least two separate components including a bicarbonate concentrate and an electrolyte concentrate which can be readily and sterilely mixed to form a ready-to-use formulation for patient administration, particularly as applied to treat acute renal failure associated with critically ill patients in an intensive care setting.
- a two part dialysis solution at least includes a first component and a second component.
- the first component at least includes a bicarbonate concentrate and the second component at least includes an electrolyte concentrate.
- the first and second components can include a variety of other suitable constituents to ensure that the first and second components can be readily and sterilely mixed to form ready-to-use formulations.
- the first and second components each include physiological acceptable amounts of sodium, such as an amount of 160 mmol/L or less.
- the first and second components each include physiological acceptable amounts of potassium, such as an amount that ranges from about 0.1 mmol/L to about 5 mmol/L.
- the first component which contains the bicarbonate concentrate does not include potassium where the second component does include potassium.
- the ready-to-use formulations of the present invention can be prepared in a number of suitable ways.
- the first and second components are separately stored from each other, such as in separate and hydraulically connected chambers of a multi-chamber container, until mixed together to form a mixed solution.
- the ready-to-use formulation can be prepared within the container by mixing its two components within one chamber of the container. This can effectively eliminate the need to manually inject all or at least a portion of the components into the container to form the mixed solution, thus ensuring that the ready-to-use formulation can be readily prepared under sterile conditions.
- the container can be configured such that one of the components can be placed in direct fluid communication with the patient prior to mixing while the other component cannot be placed in direct fluid communication with the patient prior to mixing.
- This can provide an added level of safety with respect to the preparation and administration of the ready-to-use formulation of the present invention as the component that cannot be placed in direct fluid communication with the patient physically cannot be fed to the patient unless it is first mixed with the other component.
- the component that physically cannot be placed in direct fluid communication with the patient were to have an undesirable concentration of constituents, such as potassium, sodium or the like, this configuration would necessarily ensure that the undesirable level of constituents is not fed or administered to the patient.
- the present invention provides a method of providing hemofiltration.
- the method includes the steps of providing a first component and a second components as previously discussed, mixing the first and second components to form a mixed solution and using the mixed solution during hemofiltration.
- the mixed solution is used as a dialysate.
- the mixed solution is administered as an infusion solution during continuous renal replacement therapy.
- An advantage of the present invention is to provide improved bicarbonate-based solutions.
- Another advantage of the present invention is to provide improved bicarbonate containing solutions which include a number of components, such as an electrolyte concentrate and a bicarbonate concentrate, that can be readily and sterilely mixed to form a ready-to-use formulation suitable for administration to a patient during medical therapy including dialysis therapy.
- a number of components such as an electrolyte concentrate and a bicarbonate concentrate
- Still another advantage of the present invention is to provide improved systems and methods for providing bicarbonate-based solutions to patients during dialysis therapy.
- Yet another advantage of the present invention is to provide medical treatments that employ improved bicarbonate-based solutions to treat, for example, acute renal failure during continuous renal replacement therapy.
- a further advantage of the present invention is to provide two-part bicarbonate containing solutions that can be readily and sterilely formed to facilitate their use during medical therapy, particularly in an intensive care setting.
- a still further advantage of the present invention is to provide a multi-chamber container that separately houses bicarbonate and electrolyte concentrates such that ready-to-use bicarbonate based formulations can be prepared by mixing the bicarbonate and electrolyte concentrates in the multi-chamber container thereby effectively eliminating the need to add one or more components, such as potassium chloride, to the bicarbonate based formulation via manual injection.
- FIG. 1 illustrates a multi-chamber bag for storing a bicarbonate containing solution made pursuant to the present invention.
- the present invention provides improved bicarbonate-based solutions that can be effectively administered to a patient during medical therapy, particularly dialysis therapy.
- the bicarbonate containing solution of the present invention includes at least two separate components including a bicarbonate concentrate and an electrolyte concentrate which can be readily and sterilely mixed to form a ready-to-use formulation for patient administration.
- the bicarbonate-based solution can be effectively utilized in a number of different medical applications including, for example, dialysis therapy.
- dialysis therapy can be used in a variety of different dialysis therapies to treat kidney failure.
- Dialysis therapy as the term or like terms are used throughout the text is meant to include and encompass any and all forms of therapies that utilize the patient's blood to remove waste, toxins and excess water from the patient.
- Such therapies such as hemodialysis, hemofiltration and hemodiafiltration, include both intermittent therapies and continuous therapies used for continuous renal replacement therapy (CRRT).
- CRRT continuous renal replacement therapy
- the continuous therapies include, for example, slow continuous ultrafiltration (SCUF), continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), continuous venovenous hemodiafiltration (CVVHDF), continuous arteriovenous hemofiltration (CAVH), continuous arteriovenous hemodialysis (CAVHD), continuous arteriovenous hemodiafiltration (CAVHDF), continuous ultrafiltration periodic intermittent hemodialysis or the like.
- SCUF slow continuous ultrafiltration
- CVVH continuous venovenous hemofiltration
- CVVHD continuous venovenous hemodialysis
- CVVHDF continuous venovenous hemodiafiltration
- CAVH continuous arteriovenous hemofiltration
- CAVHD continuous arteriovenous hemodialysis
- CAVHDF continuous arteriovenous hemodiafiltration
- the bicarbonate-based solution can be used as a dialysate during any suitable dialysis therapy.
- the solutions of the present invention can be administered or infused to a patient as a replacement solution, infusion solution or the like during dialysis therapy, particularly during continuous renal replacement therapy.
- replacement solutions, infusion solutions or the like must necessarily be continuously fed to a patient as a substitute for an excessive amount of plasma water that is typically removed during continuous renal replacement therapy. In this regard, a proper water balance in the patient's body can be effectively maintained.
- the bicarbonate-based solution includes sodium (Na + ), calcium (Ca ++ ), magnesium (Mg ++ ), potassium (K + ), bicarbonate (HCO 3 ⁇ ), chloride (Cl ⁇ ), lactate (CH 3 CHOHCOO ⁇ ), acetate (CH 3 COO ⁇ ), anhydrous glucose or dextrose, hydrous glucose or dextrose, like constituents and combinations thereof.
- the solution can include any suitable and physiological acceptable and effective amounts of the constituents.
- physiological acceptable means any suitable amount of a constituent or constituents of the bicarbonate based solution of the present invention (e.g., potassium, sodium or the like) that can be administered to a patient in a safe, acceptable and/or tolerable manner.
- the solution includes about 100 mmol/L to about 160 mmol/L of sodium, preferably about 130 mmol/L to about 150 mmol/L of sodium; about 0 mmol/L to about 2.0 mmol/L of calcium, preferably about 0 mmol/L to about 1.75 mmol/L of calcium, more preferably about 0.2 mmol/L to about 2.0 mmol/L of calcium; about 0 mmol/L to about 1.5 mmol/L of magnesium, preferably about 0.25 mmol/L to about 0.75 mmol/L of magnesium; about 0 mmol/L to about 5 mmol/L of potassium, preferably about 0 mmol/L to about 4 mmol/L of potassium; about 20 mmol/L to about 45 mmol/L of bicarbonate, preferably about 25 mmol/L to about 35 mmol/L of bicarbonate; about 70 mmol/L to about 130 mmol/L of chloride, preferably about 70 mmol/
- the bicarbonate-based solution of the present invention includes a number of constituents or components that are separately housed such that the components can be readily and sterilely mixed to form the resulting bicarbonate-based solution.
- the bicarbonate-based solution of the present invention can eliminate the need of excessive handling of one or more of its components prior to mixing as compared to conventional solutions which necessarily require a physician or other medical care provider to manually inject one or more components, such as bicarbonate, potassium chloride and the like, during the formulation of the bicarbonate solution.
- the ready-to-use bicarbonate-based formulations of the present invention can decrease the amount of time and effort with respect to the preparation and administration of the formulations of the present invention as compared to conventional bicarbonate formulations.
- the ready-to-use formulations of the present invention can also effectively eliminate, or at least greatly minimize, the potential of the spread of biological contamination during the preparation, administration and/or general use thereof.
- Such attributes of the bicarbonate-based formulations of the present invention are desirable as applied to medical therapies, particularly in an intensive care setting.
- the components of the solution can be housed or contained in any suitable manner such that the bicarbonate-based solutions of the present invention can be effectively prepared and administered.
- the present invention includes a two part bicarbonate-containing solution in which each part or component are formulated and stored separately, and then mixed just prior to use.
- a variety of containers can be used to house the two part bicarbonate-containing solution, such as separate containers (i.e., flasks or bags) that are connected by a suitable fluid communication mechanism.
- a multi-chamber container or bag can be used to house the separate components of the solution.
- FIG. 1 illustrates a suitable container for storing, formulating and administering a bicarbonate-based solution of the present invention.
- the multi-chamber bag 10 has a first chamber 12 and a second chamber 14 .
- the interior of the container is divided by a heat seal 16 into two chambers.
- the container can be divided into separate chambers by any suitable seal.
- the container can be divided into separate chambers, such as two chambers, by a peel seal.
- the multi-chamber container 10 also has a frangible connector 18 to sealingly couple the first chamber 12 to the second chamber 14 . To mix the solution within the multi-chamber bag 10 , the frangible connector 18 is broken.
- the first container or chamber 12 includes two port tubes having, for example, different lengths. As shown in FIG. 1 , the short port tube 20 can be utilized to add other constituents to the first chamber 12 during formulation of the solution of the present invention, if necessary.
- the long port tube 22 can be utilized to adaptedly couple the first chamber 12 to the patient via, for example, a patient's administration line (not shown).
- the second container or chamber 14 has a single port tube 24 extending therefrom which is closed by, for example, a solid rod (not shown). In this regard, it is not possible to add any additional constituents to this chamber and/or connect this chamber to a patient's administration line such that the chamber 14 cannot be adapted to deliver its constituents to the patient.
- the transfer of product within the multi-chamber bag 10 is thereby initiated from the second chamber 14 to the first chamber 12 such that the components of each chamber can be properly mixed to form the bicarbonate-based solution of the present invention.
- the first chamber 12 is larger in volume than the second chamber 14 such that the components of each chamber can be properly mixed once the transfer from the second chamber to the first chamber has occurred.
- the multi-chamber bag 10 can house at least two non-compatible solutions that after mixture will result in a ready-to-use dialysis solution.
- An example of the multi-chamber container is set forth in U.S. Pat. No. 5,431,496, the disclosure of which is incorporated herein by reference.
- the multi-chamber bag can be made from a gas permeable material, such as polypropylene, polyvinyl chloride or the like.
- the multi-chamber bag can be manufactured from a variety of different and suitable materials and configured in a number of suitable ways such that the bicarbonate-based solution of the present invention can be effectively formulated and administered to the patient during medical therapy.
- the second chamber can be larger in volume than the first chamber such that the bicarbonate-based solution of the present invention can be readily and effectively made and administered to the patient from the second chamber.
- the multi-chamber container disclosed herein is designed to be used for any medical procedure that requires bicarbonate
- the embodiment illustrated in FIG. 1 is conveniently used for dialysis therapy including, for example, continuous renal replacement therapy.
- the components of the bicarbonate-based solution of the present invention are separately housed in either of the first chamber 12 and the second chamber 14 such that a mixed solution of the components of the first chamber 12 and the second chamber 14 can be sterilely and readily formed upon mixing within the multi-chamber container.
- the first chamber 12 contains a bicarbonate concentrate and the second chamber 14 contains an electrolyte concentrate.
- the bicarbonate and electrolyte concentrates can include any variety of different and suitable constituents in varying and suitable amounts such that, when mixed, a desirable and suitable bicarbonate based solution can be formed.
- the bicarbonate concentrate includes sodium chloride (NaCl), sodium hydroxide (NaOH), sodium bicarbonate (NaHCO 3 ), the like or suitable combinations thereof
- the electrolyte concentrate includes hydrated calcium chloride (CaCl 2 .2H 2 O), hydrated magnesium chloride (MgCl 2 .6H 2 O), sodium chloride (NaCl), potassium chloride (KCl), glucose including, for example, anhydrous glucose or dextrose, hydrous glucose or dextrose, the like or suitable combinations thereof.
- the bicarbonate and electrolyte concentrates can include any suitable pH such that a physiological acceptable pH of the final or reconstituted bicarbonate-based solution can be achieved.
- the bicarbonate-based solution can be formulated under moderate or extreme pH conditions. It should be appreciated that the bicarbonate-based solution can be formulated in any suitable manner under moderate or extreme pH conditions.
- the bicarbonate-based solution can be formulated under extreme pH conditions as disclosed in U.S. Pat. No. 6,309,673, the disclosure of which is incorporated herein by reference.
- Such a formulation allows the product to be packaged without an over pouch.
- the bicarbonate-based solution of the present invention is formulated under moderate pH conditions.
- a product is placed in a container that includes a gas barrier over pouch.
- the bicarbonate-based solution of the present invention is formulated by the mixing of a bicarbonate concentrate with a pH ranging from about 7.2 to about 7.9, preferably from about 7.4 to about 7.6, and an electrolyte concentrate with a pH ranging from about 3.0 to about 5.0, preferably from about 4.3 to about 4.5.
- a bicarbonate concentrate with a pH ranging from about 8.6 to about 9.5, preferably from about 8.9 to about 9.0 is mixed with an electrolyte concentrate having a pH that ranges from about 1.7 to about 2.2, preferably about 1.9.
- a variety of different and suitable acidic and/or basic agents can be utilized to adjust the pH of the bicarbonate and/or electrolyte concentrates.
- a variety of inorganic acids and bases can be utilized including hydrochloric acid, sulfuric acid, nitric acid, hydrogen bromide, hydrogen iodide, sodium hydroxide, the like or combinations thereof.
- the present invention provides method and systems for effectively providing a bicarbonate containing solution to a patient during medical therapy.
- the present invention can be effectively utilized to treat acute renal failure, particularly with respect to critically ill patients in an intensive care setting.
- the present invention can provide ready-to-use bicarbonate-based solutions that can be effectively and sterilely administered to the patient during therapy.
- the ready-to-use formulations can include a number of integrated mechanisms to facilitate the safe and effective use of the bicarbonate-based solutions of the present invention during medical therapy.
- the bicarbonate concentrate and the electrolyte concentrate include a physiological acceptable amount of sodium.
- the sodium chloride content can be distributed between the bicarbonate concentrate and the electrolyte concentrate such that each contains an equimolar and physiological acceptable concentration of sodium.
- the equimolar amount of sodium is about 160 mmol/L or less. In an embodiment, the equimolar amount of sodium is about 100 mmol/L or more. In an embodiment, the equimolar amount sodium ranges from about 100 mmol/L to about 160 mmol/L, preferably from about 130 mmol/L to about 150 mmol/L, more preferably about 140 mmol/L. In this regard, if the concentrates remain unmixed prior to patient administration (i.e., the frangible connector remains unbroken), this would necessarily ensure that the patient is not overloaded with sodium through the administration of, for example, the bicarbonate concentrate which can be directly coupled to the patient.
- the first chamber 12 of the multi-chamber bag 10 contains the bicarbonate concentrate.
- the bicarbonate concentrate includes a physiological acceptable buffered solution of bicarbonate. This ensures that the patient is not overloaded with a number of electrolytes if, for example, the bicarbonate concentrate is separately and mistakenly administered to the patient. This can occur if the frangible connector remains unbroken and, thus, the bicarbonate concentrate and electrolyte concentrate are not mixed prior to administration to the patient where the bicarbonate concentrate is contained in a chamber which is directly coupled to the patient.
- potassium is solely contained in a chamber of the multi-chamber container of the present invention which physically cannot be placed in direct access to the patient.
- the potassium cannot be placed in direct fluid communication with the patient without mixing with the other components of the solution.
- the bicarbonate concentrate which can be placed in direct fluid communication with the patient does not contain potassium, such as potassium derived from, for example, potassium chloride or the like.
- the potassium chloride is contained solely in the electrolyte concentrate to ensure that the patient cannot receive an undesirable concentration thereof if, by chance, the bicarbonate concentrate and the electrolyte concentrate were not mixed prior to patient administration.
- the bicarbonate-based solution of the present invention can be configured such that the patient cannot receive the electrolyte concentrate directly but rather as a part of a mixed solution of the bicarbonate concentrate and the electrolyte concentrate.
- any physiological acceptable amounts of one or more electrolytes can be contained within a chamber of the multi-chamber container (e.g., the first chamber 12 of the multi-bag container 10 as discussed above) of the present invention which can be placed in direct access or fluid communication with the patient.
- the chamber that can be placed in direct fluid communication with the patient can include a physiological acceptable amount of potassium, sodium, the like or combinations thereof.
- the chamber that can be placed in direct access or fluid communication with the patient does not include potassium or the like.
- the chamber that can be placed in direct access or fluid communication with the patient houses the bicarbonate concentrate of the present invention.
- each of the bicarbonate concentrate and the electrolyte concentrate include a physiological acceptable amount of potassium prior to mixing such that the resultant solution of bicarbonate and electrolyte concentrates contains a desirable and suitable level of potassium ranging from about 0.1 mmol/L to about 5 mmol/L.
- Example one identifies three different formulations of the bicarbonate-based solution pursuant to an embodiment of the present invention.
- Tables 1A and 1B illustrate the final or reconstituted formulations of the bicarbonate-based solution in mmol/L (Table 1A) or g/L (Table 1B).
- Table 1C illustrates the content of the electrolyte concentrate associated with each formulation prior to mixing with the bicarbonate concentrate (g/L in top portion of Table 1C and mmol/L in bottom portion of Table 1C).
- Table 1D illustrates the content of the bicarbonate concentrate associated with each formulation prior to mixing with the electrolyte concentrate (g/L in top portion of Table 1D and mmol/L in bottom portion of Table 1D).
- Table 1E illustrates the measured pH under moderate pH conditions of the mixed solution (e.g., formulations 1-3), the pH of the small chamber prior to mixing (e.g., the electrolyte concentrate) and the pH of the large chamber prior to mixing (e.g., the bicarbonate concentrate).
- Example two illustrates an example of Formulations 1-3 (See, Tables 1A and 1B) prepared by mixing a bicarbonate concentrate and an electrolyte concentrate under extreme pH conditions pursuant to an embodiment of the present invention.
- Table 2A illustrates the content of the bicarbonate concentrate associated with each formulation prior to mixing with the electrolyte concentrate (g/L in top portion of Table 2A and mmol/L in bottom portion of Table 2A).
- Table 2B illustrates the content of the electrolyte concentrate associated with each formulation prior to mixing with the bicarbonate concentrate (g/L in top portion of Table 2B and mmol/L in bottom portion of Table 2B).
- Table 2C illustrates the measured pH under extreme pH conditions of the mixed solution (e.g., formulations 1-3), the pH of the small chamber prior to mixing (e.g., the bicarbonate concentrate) and the pH of the large chamber prior to mixing (e.g., the electrolyte concentrate).
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Urology & Nephrology (AREA)
- Hematology (AREA)
- Inorganic Chemistry (AREA)
- Diabetes (AREA)
- Emergency Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- External Artificial Organs (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
- This patent application is a continuation of U.S. application Ser. No. 10/044,234, filed on Jan. 11, 2002, the disclosure of which is herein incorporated by reference.
- The present invention relates generally to medical treatments. More specifically, the present invention relates to bicarbonate-based solutions for use during dialysis therapies, such as continuous renal replacement therapies.
- A variety of different medical treatments are known and used to treat critically ill patients for acute renal failure (ARF) which is typically associated with multiple organ failure syndrome in intensive care settings. For example, traditional dialysis therapies, such as hemodialysis and peritoneal dialysis, are commonly used to treat ARF.
- However, because traditional dialysis therapies are known to have limited use with respect to the treatment of critically ill patients for ARF, the use of continuous renal replacement therapy in favor of traditional dialysis therapies has increased, particularly in intensive care settings. In this regard, a number of possible advantages with respect to CRRT in comparison to traditional dialysis therapies have been recognized.
- A foremost advantage is the potential to effectively avoid, or at least minimize, cardiovascular instability. In this regard, CRRT, in general, is a slow and continuous therapy that does not include rapid shifts in blood volume and electrolyte concentration due to the removal of metabolic products from blood as compared to traditional forms of dialysis therapy, such as hemodialysis. Examples of continuous renal replacement therapies include continuous arteriovenous hemofiltration, continuous arteriovenous hemodiafiltration, continuous venovenous hemofiltration, continuous venovenous hemodiafiltration, slow continuous ultrafiltration and continuous ultrafiltration periodic intermittent hemodialysis.
- In general, CRRT is a convective blood cleansing technique that utilizes a patient's blood pressure as the primary driving force for ultrafiltration. During CRRT therapy, blood typically flows through a hemofilter such that a transmembrane pressure gradient between the blood compartment and the ultrafiltrate compartment causes plasma water to be filtered across the highly permeable membrane. As the water crosses the membrane, it can convect small and large molecules across the membrane and thus cleanse the blood.
- An excessive amount of plasma water is also removed during continuous renal replacement therapy. In order to maintain a proper water balance in the patient's body, fluid must be substituted continuously by a balanced electrolyte solution (replacement or substitution fluid). The substitution fluid can be infused intravenously either into the arterial blood line leading to the hemofilter (predilution) or into the venous blood line leaving the hemofilter (post dilution).
- Typically, commercially available replacement fluids are lactate-based solutions. However, the physiological buffer bicarbonate is preferred over lactate in patients with multiple organ failure which is typically associated with ARF. In this regard, the metabolic conversion of lactate to bicarbonate is not required prior to metabolic action thus eliminating undesirable effects due to the conversion process of lactate to bicarbonate.
- Further, it is common practice among intensive care physicians to manually prepare solutions buffered with bicarbonate extemporaneously. This is typically carried out by adding the prepared bicarbonate solution to an existing sterile solution to form the bicarbonate-based solution prior to administration to the patient. For example, it is known to add bicarbonate to an acidic electrolyte concentrate solution which is in direct contact with administration tubing connected to the patient prior to administration thereof to the patient. It is also common practice to manually inject other electrolytes, such as potassium chloride, directly and separately into the bicarbonate-based solution prior to administration.
- However, the physical handling due to the initial preparation of a bicarbonate solution, subsequent addition thereof to another solution and manual injection of other components to form the resultant bicarbonate-based solution prior to administration may be too tedious and time-consuming to adequately address the time-sensitive nature of responding to ARF in an intensive care setting. This practice may also necessarily cause the bicarbonate to degrade into a volatile carbon dioxide gas and a carbonate ion, which then can react with calcium and magnesium ions in solution to undesirably form precipitates, thus impeding proper administration. Further, the potential of bacteriological contamination of the bicarbonate-based solution is great unless strict aseptic techniques are followed during preparation.
- A need, therefore, exists to provide improved bicarbonate-based solutions that can be effectively administered during continuous renal replacement therapy to treat ARF, particularly as administered to critically ill patients in an intensive care setting.
- The present invention provides improved bicarbonate containing solutions that can be effectively administered during dialysis therapy, such as continuous renal replacement therapy. The bicarbonate containing solution of the present invention includes at least two separate components including a bicarbonate concentrate and an electrolyte concentrate which can be readily and sterilely mixed to form a ready-to-use formulation for patient administration, particularly as applied to treat acute renal failure associated with critically ill patients in an intensive care setting.
- In an embodiment, a two part dialysis solution is provided. The two part dialysis solution at least includes a first component and a second component. The first component at least includes a bicarbonate concentrate and the second component at least includes an electrolyte concentrate. The first and second components can include a variety of other suitable constituents to ensure that the first and second components can be readily and sterilely mixed to form ready-to-use formulations.
- For example, the first and second components, in an embodiment, each include physiological acceptable amounts of sodium, such as an amount of 160 mmol/L or less. In an embodiment, the first and second components each include physiological acceptable amounts of potassium, such as an amount that ranges from about 0.1 mmol/L to about 5 mmol/L. Alternatively, the first component which contains the bicarbonate concentrate does not include potassium where the second component does include potassium.
- The ready-to-use formulations of the present invention can be prepared in a number of suitable ways. In an embodiment, the first and second components are separately stored from each other, such as in separate and hydraulically connected chambers of a multi-chamber container, until mixed together to form a mixed solution. In this regard, the ready-to-use formulation can be prepared within the container by mixing its two components within one chamber of the container. This can effectively eliminate the need to manually inject all or at least a portion of the components into the container to form the mixed solution, thus ensuring that the ready-to-use formulation can be readily prepared under sterile conditions.
- Further, the container can be configured such that one of the components can be placed in direct fluid communication with the patient prior to mixing while the other component cannot be placed in direct fluid communication with the patient prior to mixing. This can provide an added level of safety with respect to the preparation and administration of the ready-to-use formulation of the present invention as the component that cannot be placed in direct fluid communication with the patient physically cannot be fed to the patient unless it is first mixed with the other component. In this regard, if, by chance, the component that physically cannot be placed in direct fluid communication with the patient were to have an undesirable concentration of constituents, such as potassium, sodium or the like, this configuration would necessarily ensure that the undesirable level of constituents is not fed or administered to the patient.
- In another embodiment, the present invention provides a method of providing hemofiltration. The method includes the steps of providing a first component and a second components as previously discussed, mixing the first and second components to form a mixed solution and using the mixed solution during hemofiltration.
- In an embodiment, the mixed solution is used as a dialysate. Alternatively, in an embodiment, the mixed solution is administered as an infusion solution during continuous renal replacement therapy.
- An advantage of the present invention is to provide improved bicarbonate-based solutions.
- Another advantage of the present invention is to provide improved bicarbonate containing solutions which include a number of components, such as an electrolyte concentrate and a bicarbonate concentrate, that can be readily and sterilely mixed to form a ready-to-use formulation suitable for administration to a patient during medical therapy including dialysis therapy.
- Still another advantage of the present invention is to provide improved systems and methods for providing bicarbonate-based solutions to patients during dialysis therapy.
- Yet another advantage of the present invention is to provide medical treatments that employ improved bicarbonate-based solutions to treat, for example, acute renal failure during continuous renal replacement therapy.
- A further advantage of the present invention is to provide two-part bicarbonate containing solutions that can be readily and sterilely formed to facilitate their use during medical therapy, particularly in an intensive care setting.
- A still further advantage of the present invention is to provide a multi-chamber container that separately houses bicarbonate and electrolyte concentrates such that ready-to-use bicarbonate based formulations can be prepared by mixing the bicarbonate and electrolyte concentrates in the multi-chamber container thereby effectively eliminating the need to add one or more components, such as potassium chloride, to the bicarbonate based formulation via manual injection.
- Additional features and advantages of the present invention are described in, and will be apparent from, the following Detailed Description of the Invention and the figures.
-
FIG. 1 illustrates a multi-chamber bag for storing a bicarbonate containing solution made pursuant to the present invention. - The present invention provides improved bicarbonate-based solutions that can be effectively administered to a patient during medical therapy, particularly dialysis therapy. The bicarbonate containing solution of the present invention includes at least two separate components including a bicarbonate concentrate and an electrolyte concentrate which can be readily and sterilely mixed to form a ready-to-use formulation for patient administration. The bicarbonate-based solution can be effectively utilized in a number of different medical applications including, for example, dialysis therapy.
- With respect to dialysis therapy, the present invention can be used in a variety of different dialysis therapies to treat kidney failure. Dialysis therapy as the term or like terms are used throughout the text is meant to include and encompass any and all forms of therapies that utilize the patient's blood to remove waste, toxins and excess water from the patient. Such therapies, such as hemodialysis, hemofiltration and hemodiafiltration, include both intermittent therapies and continuous therapies used for continuous renal replacement therapy (CRRT). The continuous therapies include, for example, slow continuous ultrafiltration (SCUF), continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), continuous venovenous hemodiafiltration (CVVHDF), continuous arteriovenous hemofiltration (CAVH), continuous arteriovenous hemodialysis (CAVHD), continuous arteriovenous hemodiafiltration (CAVHDF), continuous ultrafiltration periodic intermittent hemodialysis or the like. Further, although the present invention, in an embodiment, can be utilized in methods providing a dialysis therapy for patients having chronic kidney failure or disease, it should be appreciated that the present invention can be used for acute dialysis needs, for example, in an emergency room setting. Lastly, as one of skill in the art appreciates, the intermittent forms of therapy (i.e., hemofiltration, hemodialysis and hemodiafiltration) may be used in the in center, self/limited care as well as the home settings.
- In an embodiment, the bicarbonate-based solution can be used as a dialysate during any suitable dialysis therapy. In an embodiment, the solutions of the present invention can be administered or infused to a patient as a replacement solution, infusion solution or the like during dialysis therapy, particularly during continuous renal replacement therapy. As previously discussed, replacement solutions, infusion solutions or the like must necessarily be continuously fed to a patient as a substitute for an excessive amount of plasma water that is typically removed during continuous renal replacement therapy. In this regard, a proper water balance in the patient's body can be effectively maintained.
- In an embodiment, the bicarbonate-based solution includes sodium (Na+), calcium (Ca++), magnesium (Mg++), potassium (K+), bicarbonate (HCO3 −), chloride (Cl−), lactate (CH3CHOHCOO−), acetate (CH3COO−), anhydrous glucose or dextrose, hydrous glucose or dextrose, like constituents and combinations thereof. The solution can include any suitable and physiological acceptable and effective amounts of the constituents. The term “physiological acceptable” as used herein means any suitable amount of a constituent or constituents of the bicarbonate based solution of the present invention (e.g., potassium, sodium or the like) that can be administered to a patient in a safe, acceptable and/or tolerable manner.
- In an embodiment, the solution includes about 100 mmol/L to about 160 mmol/L of sodium, preferably about 130 mmol/L to about 150 mmol/L of sodium; about 0 mmol/L to about 2.0 mmol/L of calcium, preferably about 0 mmol/L to about 1.75 mmol/L of calcium, more preferably about 0.2 mmol/L to about 2.0 mmol/L of calcium; about 0 mmol/L to about 1.5 mmol/L of magnesium, preferably about 0.25 mmol/L to about 0.75 mmol/L of magnesium; about 0 mmol/L to about 5 mmol/L of potassium, preferably about 0 mmol/L to about 4 mmol/L of potassium; about 20 mmol/L to about 45 mmol/L of bicarbonate, preferably about 25 mmol/L to about 35 mmol/L of bicarbonate; about 70 mmol/L to about 130 mmol/L of chloride, preferably about 70 mmol/L to about 120 mmol/L of chloride, more preferably about 91 mmol/L to about 128 mmol/L of chloride; about 0 mmol/L to about 45 mmol/L of lactate, preferably about 0 mmol/L to about 35 mmol/L of lactate; about 0 mmol/L to about 45 mmol/L of acetate, preferably about 0 mmol/L to about 35 mmol/L of acetate; about 0 g/L to about 2.5g/L glucose, preferably about 0 g/L to about 2.0 g/L of glucose; or combinations thereof. Applicants have found that the bicarbonate-based solutions of the present invention are stable for over a six month period at a physiological acceptable pH ranging from about 6.5 to about 8.0 at 25° C., preferably at a pH ranging from about 7.1 to about 7.4.
- As previously discussed, the bicarbonate-based solution of the present invention includes a number of constituents or components that are separately housed such that the components can be readily and sterilely mixed to form the resulting bicarbonate-based solution. Applicants have discovered that the bicarbonate-based solution of the present invention can eliminate the need of excessive handling of one or more of its components prior to mixing as compared to conventional solutions which necessarily require a physician or other medical care provider to manually inject one or more components, such as bicarbonate, potassium chloride and the like, during the formulation of the bicarbonate solution.
- In this regard, the ready-to-use bicarbonate-based formulations of the present invention can decrease the amount of time and effort with respect to the preparation and administration of the formulations of the present invention as compared to conventional bicarbonate formulations. The ready-to-use formulations of the present invention can also effectively eliminate, or at least greatly minimize, the potential of the spread of biological contamination during the preparation, administration and/or general use thereof. Such attributes of the bicarbonate-based formulations of the present invention are desirable as applied to medical therapies, particularly in an intensive care setting.
- It should be appreciated that the components of the solution can be housed or contained in any suitable manner such that the bicarbonate-based solutions of the present invention can be effectively prepared and administered. In an embodiment, the present invention includes a two part bicarbonate-containing solution in which each part or component are formulated and stored separately, and then mixed just prior to use. A variety of containers can be used to house the two part bicarbonate-containing solution, such as separate containers (i.e., flasks or bags) that are connected by a suitable fluid communication mechanism. In an embodiment, a multi-chamber container or bag can be used to house the separate components of the solution.
-
FIG. 1 illustrates a suitable container for storing, formulating and administering a bicarbonate-based solution of the present invention. Themulti-chamber bag 10 has afirst chamber 12 and asecond chamber 14. The interior of the container is divided by aheat seal 16 into two chambers. It should be appreciated that the container can be divided into separate chambers by any suitable seal. In an embodiment, the container can be divided into separate chambers, such as two chambers, by a peel seal. Themulti-chamber container 10 also has afrangible connector 18 to sealingly couple thefirst chamber 12 to thesecond chamber 14. To mix the solution within themulti-chamber bag 10, thefrangible connector 18 is broken. - The first container or
chamber 12 includes two port tubes having, for example, different lengths. As shown inFIG. 1 , theshort port tube 20 can be utilized to add other constituents to thefirst chamber 12 during formulation of the solution of the present invention, if necessary. Thelong port tube 22 can be utilized to adaptedly couple thefirst chamber 12 to the patient via, for example, a patient's administration line (not shown). The second container orchamber 14 has asingle port tube 24 extending therefrom which is closed by, for example, a solid rod (not shown). In this regard, it is not possible to add any additional constituents to this chamber and/or connect this chamber to a patient's administration line such that thechamber 14 cannot be adapted to deliver its constituents to the patient. - In an embodiment, the transfer of product within the
multi-chamber bag 10 is thereby initiated from thesecond chamber 14 to thefirst chamber 12 such that the components of each chamber can be properly mixed to form the bicarbonate-based solution of the present invention. In this regard, thefirst chamber 12 is larger in volume than thesecond chamber 14 such that the components of each chamber can be properly mixed once the transfer from the second chamber to the first chamber has occurred. Thus, themulti-chamber bag 10 can house at least two non-compatible solutions that after mixture will result in a ready-to-use dialysis solution. An example of the multi-chamber container is set forth in U.S. Pat. No. 5,431,496, the disclosure of which is incorporated herein by reference. The multi-chamber bag can be made from a gas permeable material, such as polypropylene, polyvinyl chloride or the like. - It should be appreciated that the multi-chamber bag can be manufactured from a variety of different and suitable materials and configured in a number of suitable ways such that the bicarbonate-based solution of the present invention can be effectively formulated and administered to the patient during medical therapy. For example, the second chamber can be larger in volume than the first chamber such that the bicarbonate-based solution of the present invention can be readily and effectively made and administered to the patient from the second chamber.
- Although the multi-chamber container disclosed herein is designed to be used for any medical procedure that requires bicarbonate, the embodiment illustrated in
FIG. 1 is conveniently used for dialysis therapy including, for example, continuous renal replacement therapy. To this end, in an embodiment, the components of the bicarbonate-based solution of the present invention are separately housed in either of thefirst chamber 12 and thesecond chamber 14 such that a mixed solution of the components of thefirst chamber 12 and thesecond chamber 14 can be sterilely and readily formed upon mixing within the multi-chamber container. - In an embodiment, the
first chamber 12 contains a bicarbonate concentrate and thesecond chamber 14 contains an electrolyte concentrate. The bicarbonate and electrolyte concentrates can include any variety of different and suitable constituents in varying and suitable amounts such that, when mixed, a desirable and suitable bicarbonate based solution can be formed. In an embodiment, the bicarbonate concentrate includes sodium chloride (NaCl), sodium hydroxide (NaOH), sodium bicarbonate (NaHCO3), the like or suitable combinations thereof, and the electrolyte concentrate includes hydrated calcium chloride (CaCl2.2H2O), hydrated magnesium chloride (MgCl2.6H2O), sodium chloride (NaCl), potassium chloride (KCl), glucose including, for example, anhydrous glucose or dextrose, hydrous glucose or dextrose, the like or suitable combinations thereof. - It should be appreciated that the bicarbonate and electrolyte concentrates can include any suitable pH such that a physiological acceptable pH of the final or reconstituted bicarbonate-based solution can be achieved. In an embodiment, the bicarbonate-based solution can be formulated under moderate or extreme pH conditions. It should be appreciated that the bicarbonate-based solution can be formulated in any suitable manner under moderate or extreme pH conditions.
- For example, in an embodiment, the bicarbonate-based solution can be formulated under extreme pH conditions as disclosed in U.S. Pat. No. 6,309,673, the disclosure of which is incorporated herein by reference. Such a formulation allows the product to be packaged without an over pouch.
- In an embodiment, the bicarbonate-based solution of the present invention is formulated under moderate pH conditions. Preferably, such a product is placed in a container that includes a gas barrier over pouch.
- Under moderate pH conditions, the bicarbonate-based solution of the present invention is formulated by the mixing of a bicarbonate concentrate with a pH ranging from about 7.2 to about 7.9, preferably from about 7.4 to about 7.6, and an electrolyte concentrate with a pH ranging from about 3.0 to about 5.0, preferably from about 4.3 to about 4.5. Under extreme pH conditions, a bicarbonate concentrate with a pH ranging from about 8.6 to about 9.5, preferably from about 8.9 to about 9.0, is mixed with an electrolyte concentrate having a pH that ranges from about 1.7 to about 2.2, preferably about 1.9.
- A variety of different and suitable acidic and/or basic agents can be utilized to adjust the pH of the bicarbonate and/or electrolyte concentrates. For example, a variety of inorganic acids and bases can be utilized including hydrochloric acid, sulfuric acid, nitric acid, hydrogen bromide, hydrogen iodide, sodium hydroxide, the like or combinations thereof.
- As previously discussed, the present invention provides method and systems for effectively providing a bicarbonate containing solution to a patient during medical therapy. In an embodiment, the present invention can be effectively utilized to treat acute renal failure, particularly with respect to critically ill patients in an intensive care setting. In this regard, Applicants have uniquely discovered that the present invention can provide ready-to-use bicarbonate-based solutions that can be effectively and sterilely administered to the patient during therapy. The ready-to-use formulations can include a number of integrated mechanisms to facilitate the safe and effective use of the bicarbonate-based solutions of the present invention during medical therapy.
- In an embodiment, the bicarbonate concentrate and the electrolyte concentrate include a physiological acceptable amount of sodium. To achieve the physiological acceptable level of sodium, the sodium chloride content can be distributed between the bicarbonate concentrate and the electrolyte concentrate such that each contains an equimolar and physiological acceptable concentration of sodium.
- In an embodiment, the equimolar amount of sodium is about 160 mmol/L or less. In an embodiment, the equimolar amount of sodium is about 100 mmol/L or more. In an embodiment, the equimolar amount sodium ranges from about 100 mmol/L to about 160 mmol/L, preferably from about 130 mmol/L to about 150 mmol/L, more preferably about 140 mmol/L. In this regard, if the concentrates remain unmixed prior to patient administration (i.e., the frangible connector remains unbroken), this would necessarily ensure that the patient is not overloaded with sodium through the administration of, for example, the bicarbonate concentrate which can be directly coupled to the patient.
- As previously discussed, the
first chamber 12 of themulti-chamber bag 10 contains the bicarbonate concentrate. In an embodiment, the bicarbonate concentrate includes a physiological acceptable buffered solution of bicarbonate. This ensures that the patient is not overloaded with a number of electrolytes if, for example, the bicarbonate concentrate is separately and mistakenly administered to the patient. This can occur if the frangible connector remains unbroken and, thus, the bicarbonate concentrate and electrolyte concentrate are not mixed prior to administration to the patient where the bicarbonate concentrate is contained in a chamber which is directly coupled to the patient. - In an embodiment, potassium is solely contained in a chamber of the multi-chamber container of the present invention which physically cannot be placed in direct access to the patient. In this regard, the potassium cannot be placed in direct fluid communication with the patient without mixing with the other components of the solution. For example, in an embodiment, the bicarbonate concentrate which can be placed in direct fluid communication with the patient does not contain potassium, such as potassium derived from, for example, potassium chloride or the like. In an embodiment, the potassium chloride is contained solely in the electrolyte concentrate to ensure that the patient cannot receive an undesirable concentration thereof if, by chance, the bicarbonate concentrate and the electrolyte concentrate were not mixed prior to patient administration. In this regard, the bicarbonate-based solution of the present invention can be configured such that the patient cannot receive the electrolyte concentrate directly but rather as a part of a mixed solution of the bicarbonate concentrate and the electrolyte concentrate.
- It should be appreciated that a variety of suitable and additional configurations of the present invention can be utilized to facilitate the safe and effective administration of the bicarbonate-based solution to a patient during therapy. In an embodiment, any physiological acceptable amounts of one or more electrolytes can be contained within a chamber of the multi-chamber container (e.g., the
first chamber 12 of themulti-bag container 10 as discussed above) of the present invention which can be placed in direct access or fluid communication with the patient. For example, the chamber that can be placed in direct fluid communication with the patient can include a physiological acceptable amount of potassium, sodium, the like or combinations thereof. In an embodiment, the chamber that can be placed in direct access or fluid communication with the patient does not include potassium or the like. In an embodiment, the chamber that can be placed in direct access or fluid communication with the patient houses the bicarbonate concentrate of the present invention. - In an embodiment, each of the bicarbonate concentrate and the electrolyte concentrate include a physiological acceptable amount of potassium prior to mixing such that the resultant solution of bicarbonate and electrolyte concentrates contains a desirable and suitable level of potassium ranging from about 0.1 mmol/L to about 5 mmol/L.
- By way of example, and not limitation, the following examples identify a variety of bicarbonate-based solutions made pursuant to an embodiment of the present invention.
-
TABLE 1A mmol/L Formulation 1 Formulation 2 Formulation 3 Na+ 140 140 140 K+ 0 2 4 Ca++ 1.75 1.75 1.75 Mg++ 0.5 0.5 0.5 Cl− 109.5 111.5 113.5 HCO3 − 35 35 35 Anhydrous dextrose 0 5.55 5.55 -
TABLE 1B g/L Formulation 1 Formulation 2 Formulation 3 Na+ 6.14 6.14 6.14 Ca++ 0.257 0.257 0.257 Mg++ 0.102 0.102 0.102 K+ 0 0.149 0.298 HCO3 − 2.94 2.94 2.94 Anhydrous dextrose 0 1.0 1.0 or hydrous dextrose 0 1.1 1.1 -
TABLE 1C Formulation 1 Formulation 2 Formulation 3 Small chamber (g/L) (vol = 906 mL) NaCl 8.18 8.18 8.18 CaCl2.2H2O 0.710 0.710 0.710 MgCl2.6H2O 0.280 0.280 0.280 KCl 0 0.411 0.822 Anhydrous dextrose 0 2.76 2.76 or hydrous dextrose 0 3.03 3.03 (mmol/L) NaCl 140 140 140 CaCl2.2H2O 4.83 4.83 4.83 MgCl2.6H2O 1.38 1.38 1.38 KCl 0 5.52 11.0 Anhydrous dextrose 0 5.55 5.55 -
TABLE 1D Formulation 1 Formulation 2 Formulation 3 Large chamber (g/L) (vol = 1594 mL) NaCl 4.97 4.97 4.97 NaHCO3 4.61 4.61 4.61 (mmol/L) NaCl 85.1 85.1 85.1 NaHCO3 54.9 54.9 54.9 -
TABLE 1E Measured pH Small Chamber (electrolyte) 4.3-4.5 Large Chamber (buffer) 7.4-7.6 Mixed solution 7.2-7.3 - Example one identifies three different formulations of the bicarbonate-based solution pursuant to an embodiment of the present invention. Tables 1A and 1B illustrate the final or reconstituted formulations of the bicarbonate-based solution in mmol/L (Table 1A) or g/L (Table 1B).
- Table 1C illustrates the content of the electrolyte concentrate associated with each formulation prior to mixing with the bicarbonate concentrate (g/L in top portion of Table 1C and mmol/L in bottom portion of Table 1C). Table 1D illustrates the content of the bicarbonate concentrate associated with each formulation prior to mixing with the electrolyte concentrate (g/L in top portion of Table 1D and mmol/L in bottom portion of Table 1D). Table 1E illustrates the measured pH under moderate pH conditions of the mixed solution (e.g., formulations 1-3), the pH of the small chamber prior to mixing (e.g., the electrolyte concentrate) and the pH of the large chamber prior to mixing (e.g., the bicarbonate concentrate).
-
TABLE 2A Formulation 1 Formulation 2 Formulation 3 Small chamber (g/L) (vol = 1125 mL) NaHCO3 13.4 13.4 13.4 NaOH 0.520 0.520 0.520 (mmol/L) NaHCO3 160 160 160 NaOH 13 13 13 -
TABLE 2B Formulation 1 Formulation 2 Formulation 3 Large chamber (g/L) (vol = 3375 mL) CaCl2.2H2O 0.343 0.343 0.343 MgCl2.6H2O 0.136 0.136 0.136 NaCl 7.54 7.54 7.54 KCl 0 0.199 0.397 Anhydrous dextrose 0 1.33 1.33 or hydrous dextrose 0 1.46 1.46 HCl 0.401 0.401 0.401 (mmol/L) CaCl2.2H2O 2.33 2.33 2.33 MgCl2.6H2O 0.667 0.667 0.667 NaCl 129 129 129 KCl 0 2.67 5.33 Anhydrous. dextrose 0 7.40 7.40 HCl 11 11 11 -
TABLE 2C Measured pH Small Chamber (buffer) 8.9-9.0 Large Chamber (electrolyte) 1.9 Mixed solution 7.1-7.3 - Example two illustrates an example of Formulations 1-3 (See, Tables 1A and 1B) prepared by mixing a bicarbonate concentrate and an electrolyte concentrate under extreme pH conditions pursuant to an embodiment of the present invention.
- Table 2A illustrates the content of the bicarbonate concentrate associated with each formulation prior to mixing with the electrolyte concentrate (g/L in top portion of Table 2A and mmol/L in bottom portion of Table 2A). Table 2B illustrates the content of the electrolyte concentrate associated with each formulation prior to mixing with the bicarbonate concentrate (g/L in top portion of Table 2B and mmol/L in bottom portion of Table 2B). Table 2C illustrates the measured pH under extreme pH conditions of the mixed solution (e.g., formulations 1-3), the pH of the small chamber prior to mixing (e.g., the bicarbonate concentrate) and the pH of the large chamber prior to mixing (e.g., the electrolyte concentrate).
- It should be understood that various charges and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.
Claims (33)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/531,121 US20070003637A1 (en) | 2002-01-11 | 2006-09-12 | Bicarbonate-based solutions for dialysis therapies |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/044,234 US7122210B2 (en) | 2002-01-11 | 2002-01-11 | Bicarbonate-based solutions for dialysis therapies |
US11/531,121 US20070003637A1 (en) | 2002-01-11 | 2006-09-12 | Bicarbonate-based solutions for dialysis therapies |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/044,234 Continuation US7122210B2 (en) | 2002-01-11 | 2002-01-11 | Bicarbonate-based solutions for dialysis therapies |
Publications (1)
Publication Number | Publication Date |
---|---|
US20070003637A1 true US20070003637A1 (en) | 2007-01-04 |
Family
ID=21931220
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/044,234 Expired - Lifetime US7122210B2 (en) | 2002-01-11 | 2002-01-11 | Bicarbonate-based solutions for dialysis therapies |
US11/531,121 Abandoned US20070003637A1 (en) | 2002-01-11 | 2006-09-12 | Bicarbonate-based solutions for dialysis therapies |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/044,234 Expired - Lifetime US7122210B2 (en) | 2002-01-11 | 2002-01-11 | Bicarbonate-based solutions for dialysis therapies |
Country Status (16)
Country | Link |
---|---|
US (2) | US7122210B2 (en) |
EP (3) | EP2322237B1 (en) |
JP (2) | JP4778681B2 (en) |
KR (4) | KR20090023747A (en) |
CN (2) | CN101219151A (en) |
AR (1) | AR038113A1 (en) |
AT (1) | ATE539782T1 (en) |
AU (1) | AU2002356899B2 (en) |
BR (1) | BR0208003A (en) |
CA (1) | CA2440455A1 (en) |
DK (3) | DK2322236T4 (en) |
ES (3) | ES2380430T5 (en) |
HK (1) | HK1065966A1 (en) |
MX (1) | MXPA03008204A (en) |
TW (1) | TWI326597B (en) |
WO (1) | WO2003059417A1 (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20140144794A1 (en) * | 2011-08-11 | 2014-05-29 | Fresenius Medical Care Deutschland Gmbh | Container for dialysis |
US9249345B2 (en) | 2010-08-18 | 2016-02-02 | Fresenius Medical Care Deutschland Gmbh | Concentrate for medical solutions, production thereof and use thereof in dialysis |
US9527627B2 (en) | 2011-05-18 | 2016-12-27 | Fresenius Medical Care Deutschland Gmbh | Connector for dialysis container, container equipped with such connector, manufacturing and filling method for such connectors and containers |
Families Citing this family (53)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7122210B2 (en) * | 2002-01-11 | 2006-10-17 | Baxter International Inc. | Bicarbonate-based solutions for dialysis therapies |
US10155082B2 (en) * | 2002-04-10 | 2018-12-18 | Baxter International Inc. | Enhanced signal detection for access disconnection systems |
US20040254513A1 (en) | 2002-04-10 | 2004-12-16 | Sherwin Shang | Conductive polymer materials and applications thereof including monitoring and providing effective therapy |
US7022098B2 (en) | 2002-04-10 | 2006-04-04 | Baxter International Inc. | Access disconnection systems and methods |
US7052480B2 (en) | 2002-04-10 | 2006-05-30 | Baxter International Inc. | Access disconnection systems and methods |
DE102004023828A1 (en) * | 2004-05-13 | 2005-12-08 | Fresenius Medical Care Deutschland Gmbh | Solution for peritoneal dialysis |
US7384558B2 (en) | 2004-07-26 | 2008-06-10 | Baxter International Inc. | Compositions capable of inhibiting reactive oxygen and carbonyl species |
SE0402507D0 (en) * | 2004-10-14 | 2004-10-14 | Gambro Lundia Ab | Medical solution, method of preparation and use thereof |
US7935070B2 (en) | 2005-01-28 | 2011-05-03 | Fresenius Medical Care North America | Systems and methods for dextrose containing peritoneal dialysis (PD) solutions with neutral pH and reduced glucose degradation product |
ATE456354T1 (en) * | 2005-09-29 | 2010-02-15 | Alcon Inc | DOUBLE CHAMBER PACKAGING SYSTEM FOR SOLUTIONS |
MX2008013266A (en) | 2006-04-14 | 2008-10-27 | Deka Products Lp | Systems, devices and methods for fluid pumping, heat exchange, thermal sensing, and conductivity sensing. |
US8366316B2 (en) * | 2006-04-14 | 2013-02-05 | Deka Products Limited Partnership | Sensor apparatus systems, devices and methods |
US10537671B2 (en) | 2006-04-14 | 2020-01-21 | Deka Products Limited Partnership | Automated control mechanisms in a hemodialysis apparatus |
JP4004523B1 (en) * | 2006-04-21 | 2007-11-07 | 株式会社日本トリム | Dialysate preparation water, dialysate using the same, dialysate production method and dialyzer |
US8491184B2 (en) | 2007-02-27 | 2013-07-23 | Deka Products Limited Partnership | Sensor apparatus systems, devices and methods |
US8042563B2 (en) | 2007-02-27 | 2011-10-25 | Deka Products Limited Partnership | Cassette system integrated apparatus |
US8562834B2 (en) | 2007-02-27 | 2013-10-22 | Deka Products Limited Partnership | Modular assembly for a portable hemodialysis system |
US9028691B2 (en) | 2007-02-27 | 2015-05-12 | Deka Products Limited Partnership | Blood circuit assembly for a hemodialysis system |
US8357298B2 (en) | 2007-02-27 | 2013-01-22 | Deka Products Limited Partnership | Hemodialysis systems and methods |
KR102228428B1 (en) | 2007-02-27 | 2021-03-16 | 데카 프로덕츠 리미티드 파트너쉽 | Hemodialysis system |
US20080253911A1 (en) | 2007-02-27 | 2008-10-16 | Deka Products Limited Partnership | Pumping Cassette |
US8409441B2 (en) | 2007-02-27 | 2013-04-02 | Deka Products Limited Partnership | Blood treatment systems and methods |
US8393690B2 (en) | 2007-02-27 | 2013-03-12 | Deka Products Limited Partnership | Enclosure for a portable hemodialysis system |
US8425471B2 (en) | 2007-02-27 | 2013-04-23 | Deka Products Limited Partnership | Reagent supply for a hemodialysis system |
US20090107335A1 (en) | 2007-02-27 | 2009-04-30 | Deka Products Limited Partnership | Air trap for a medical infusion device |
US8771508B2 (en) | 2008-08-27 | 2014-07-08 | Deka Products Limited Partnership | Dialyzer cartridge mounting arrangement for a hemodialysis system |
EP4336042A3 (en) | 2008-01-23 | 2024-05-15 | DEKA Products Limited Partnership | Fluid line autoconnect apparatus and methods for medical treatment system |
US9078971B2 (en) | 2008-01-23 | 2015-07-14 | Deka Products Limited Partnership | Medical treatment system and methods using a plurality of fluid lines |
US8708950B2 (en) | 2010-07-07 | 2014-04-29 | Deka Products Limited Partnership | Medical treatment system and methods using a plurality of fluid lines |
US20090214807A1 (en) * | 2008-02-27 | 2009-08-27 | Shawn Davis | Peelable seals including porous inserts |
US8057679B2 (en) | 2008-07-09 | 2011-11-15 | Baxter International Inc. | Dialysis system having trending and alert generation |
US8114043B2 (en) | 2008-07-25 | 2012-02-14 | Baxter International Inc. | Electromagnetic induction access disconnect sensor |
CN104841030B (en) | 2009-10-30 | 2017-10-31 | 德卡产品有限公司 | For the apparatus and method for the disconnection for detecting intravascular access device |
US9585810B2 (en) | 2010-10-14 | 2017-03-07 | Fresenius Medical Care Holdings, Inc. | Systems and methods for delivery of peritoneal dialysis (PD) solutions with integrated inter-chamber diffuser |
SG10201604167XA (en) | 2011-05-24 | 2016-07-28 | Deka Products Lp | Blood treatment systems and methods |
WO2012162515A2 (en) | 2011-05-24 | 2012-11-29 | Deka Products Limited Partnership | Hemodial ysis system |
ES2806056T3 (en) | 2011-06-24 | 2021-02-16 | Richard W C Lo | Multiple container systems and uses thereof |
EP2773395B1 (en) | 2011-11-04 | 2015-09-30 | DEKA Products Limited Partnership | Medical treatment system and methods using a plurality of fluid lines |
USD699343S1 (en) | 2011-12-20 | 2014-02-11 | Alcon Research, Ltd. | Irrigation solution bag |
JP5099464B1 (en) * | 2011-12-29 | 2012-12-19 | 富田製薬株式会社 | Bicarbonate ion concentration-variable dialysate preparation device and preparation method, bicarbonate ion concentration-variable dialysate, and bicarbonate ion concentration-variable dialyzing system |
US10098813B2 (en) * | 2014-09-03 | 2018-10-16 | Sun Pharmaceutical Industries Limited | Perfusion dosage form |
CN107810536B (en) | 2015-06-25 | 2023-01-24 | 甘布罗伦迪亚股份公司 | Medical device system and method with distributed database |
US20190183927A1 (en) * | 2016-08-11 | 2019-06-20 | Sulfilatec, Inc. | Medical and nutritional compositions and methods of use |
WO2018114346A1 (en) | 2016-12-21 | 2018-06-28 | Gambro Lundia Ab | Medical device system including information technology infrastructure having secure cluster domain supporting external domain |
MX2020005879A (en) * | 2017-12-07 | 2020-10-07 | Reven Ip Holdco Llc | Compositions and methods for the treatment of metabolic conditions. |
FR3085116A1 (en) | 2018-08-21 | 2020-02-28 | Bernard Bene | METHOD OF ALTERNATE CIRCULATION HEMODIALYSIS OF TWO TYPES OF DIALYSATE AND APPARATUS FOR CARRYING OUT SUCH A METHOD |
US11253849B2 (en) * | 2018-11-28 | 2022-02-22 | Baxter International Inc. | Systems and methods for onsite sorbent material reuse |
EP3725286A1 (en) | 2019-04-18 | 2020-10-21 | B. Braun Melsungen AG | Medicinal product comprising a container and an aqueous liquid containing bicarbonate |
WO2021160942A1 (en) | 2020-02-13 | 2021-08-19 | Bernard Bene | Hemodialysis method comprising alternating circulation of two types of dialysate and apparatus for carrying out such a method |
CN117357626A (en) | 2022-07-08 | 2024-01-09 | 杰拓保护有限公司 | Peritoneal dialysis fluid |
FR3137840B1 (en) | 2022-07-18 | 2024-08-30 | Bene Bernard | Hemodialysis process and machine with bicarbonate-buffered dialysate without acidifier |
US11925703B1 (en) | 2022-07-29 | 2024-03-12 | Xellia Pharmaceuticals Aps | Liquid composition comprising glucose |
DE102023102598A1 (en) | 2023-02-02 | 2024-08-08 | Fresenius Medical Care Deutschland Gmbh | Multi-chamber bag for the preparation of dialysate |
Citations (37)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3878664A (en) * | 1972-11-27 | 1975-04-22 | Cybersol | Process for producing a therapeutic composition |
US4372100A (en) * | 1979-11-01 | 1983-02-08 | Baxter Travenol Laboratories, Inc. | Process and apparatus for compounding hyperalimentation solutions |
US4396383A (en) * | 1981-11-09 | 1983-08-02 | Baxter Travenol Laboratories, Inc. | Multiple chamber solution container including positive test for homogenous mixture |
US4397392A (en) * | 1981-01-08 | 1983-08-09 | Intensive Technology, Inc. | Contained blood gas control |
US4465488A (en) * | 1981-03-23 | 1984-08-14 | Baxter Travenol Laboratories, Inc. | Collapsible multi-chamber medical fluid container |
US4489535A (en) * | 1980-10-02 | 1984-12-25 | Veltman Preston Leonard | Materials and method for preparing dialysis solutions containing bicarbonate ions |
US4584176A (en) * | 1984-03-19 | 1986-04-22 | Oliver James C | Method and apparatus for storing bicarbonate dialysate |
US4630727A (en) * | 1984-04-06 | 1986-12-23 | Fresenius, Ag | Container for a bicarbonate containing fluid |
US4663166A (en) * | 1984-06-22 | 1987-05-05 | Veech Richard L | Electrolyte solutions and in vivo use thereof |
US4756838A (en) * | 1980-02-21 | 1988-07-12 | Veltman Preston Leonard | Preparation of dry dialysate products |
US4761237A (en) * | 1981-07-10 | 1988-08-02 | Baxter Travenol Laboratories, Inc. | Peritoneal dialysis solution containing carbohydrate polymers |
US4863714A (en) * | 1987-02-05 | 1989-09-05 | Cook Imaging Corporation | Sterilization of compositions of limited stability |
US4879280A (en) * | 1981-09-24 | 1989-11-07 | Fresenius Ag | Dialysis solution for use in intraperitoneal dialysis |
US4959175A (en) * | 1987-01-27 | 1990-09-25 | Pierre Fabre Medicament | Solution for dialyses and use of peptides based on glycine for preparing it |
US5011826A (en) * | 1988-04-15 | 1991-04-30 | Fresenius Ag | Aqueous dialysis and rinsing solution for intraperitoneal administration |
US5039609A (en) * | 1985-09-10 | 1991-08-13 | Research Technologies, Inc. | Osmotic agents for peritoneal dialysis |
US5092838A (en) * | 1989-11-30 | 1992-03-03 | Baxter International Inc. | Histidine buffered peritoneal dialysis solution |
US5122516A (en) * | 1989-05-26 | 1992-06-16 | Terumo Kabushiki Kaisha | Preparation for blood dialysis and method for production thereof |
US5141492A (en) * | 1991-05-13 | 1992-08-25 | Dadson Joseph E | Method and apparatus for performing peritoneal dialysis |
US5211643A (en) * | 1989-05-26 | 1993-05-18 | Fresenius Ag | Sodium bicarbonate containing precipitate-free dialysis solutions |
US5296242A (en) * | 1991-08-03 | 1994-03-22 | Rolf Zander | Aqueous solution and the use thereof |
US5383324A (en) * | 1993-04-23 | 1995-01-24 | Baxter International Inc. | Method for manufacturing and storing stable bicarbonate solutions |
US5423421A (en) * | 1992-05-03 | 1995-06-13 | Otsuka Pharmaceutical Factory, Inc. | Containers having plurality of chambers |
US5431496A (en) * | 1993-01-19 | 1995-07-11 | Baxter International Inc. | Multiple chamber container |
US5462526A (en) * | 1993-09-15 | 1995-10-31 | Mcgaw, Inc. | Flexible, sterile container and method of making and using same |
US5509898A (en) * | 1993-05-10 | 1996-04-23 | Material Engineering Technology Laboratory, Inc. | Container for therapeutic use |
US5536469A (en) * | 1991-11-18 | 1996-07-16 | Gambro Ab | System employing a sterile medical solution containing glucose or glucose-like compounds and a solution intended for said system |
US5601730A (en) * | 1992-09-02 | 1997-02-11 | Pall Corporation | Process and apparatus for removal of unwanted fluids from processed blood products |
US5610170A (en) * | 1993-01-22 | 1997-03-11 | Otsuka Pharmaceutical Factory, Inc. | Package form for bicarbonate-containing powdery pharmaceutical compositions and a method of stabilizing the compositions |
US5616248A (en) * | 1992-04-06 | 1997-04-01 | Schal; Wilfried | Method for the preparation of hemodialysis fluids containing bicarbonate |
US5706937A (en) * | 1995-04-11 | 1998-01-13 | Nissho Corporation | Flexible dual-chambered container |
US5853388A (en) * | 1997-08-21 | 1998-12-29 | Semel; David | Intravenous bag with separate compartment |
US5871477A (en) * | 1995-11-28 | 1999-02-16 | Material Engineering Technology Laboratory, Incorporated | Medical container with electrolyte solution stored therein |
US5945129A (en) * | 1996-08-01 | 1999-08-31 | Fesenius Medical Care Deutschland Gmbh | Process for the production of an infusion or dialysis solution containing bicarbonate |
US6013294A (en) * | 1997-05-30 | 2000-01-11 | The Procter & Gamble Company | Shelf-stable complete pre-mixes that are combinable to form ready-to-cook mixes or food beverage products |
US6139754A (en) * | 1991-11-15 | 2000-10-31 | Baxter International Inc. | Hemodialysis conductivity servo-proportioning system and method |
US7122210B2 (en) * | 2002-01-11 | 2006-10-17 | Baxter International Inc. | Bicarbonate-based solutions for dialysis therapies |
Family Cites Families (41)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS56164113A (en) | 1980-05-21 | 1981-12-17 | Nikkiso Co Ltd | Preparation of dialysis solution |
WO1983000087A1 (en) | 1981-07-10 | 1983-01-20 | Baxter Travenol Lab | Peritoneal dialysis solution containing carbohydrate polymers |
AU571011B2 (en) | 1983-10-07 | 1988-03-31 | State Of Victoria, The | Treatment of neonatal calf diarrhoea |
EP0208709A1 (en) | 1984-12-06 | 1987-01-21 | Renal Systems, Inc. | Bacteriostatic hemodialysis concentrate |
ATE48761T1 (en) | 1985-05-31 | 1990-01-15 | Dietl Hans | DELIVERY SYSTEM FOR HEMODIALYSIS FLUID. |
AU6776887A (en) | 1985-12-18 | 1987-07-15 | Veech, R.L. | Fluid therapy with l-lactate and/or pyruvate anions |
WO1987003809A1 (en) | 1985-12-20 | 1987-07-02 | Veech Richard L | Preparation of electrolyte solutions and containers |
US4784495A (en) | 1987-02-06 | 1988-11-15 | Gambro Ab | System for preparing a fluid intended for a medical procedure by mixing at least one concentrate in powder form with water |
JPH02304026A (en) | 1989-05-16 | 1990-12-17 | Morishita Pharmaceut Co Ltd | Liquid for peritoneal lavage |
US5071558A (en) | 1989-08-11 | 1991-12-10 | Nikkiso Co., Ltd. | Sodium bicarbonate dialysate |
JPH03195561A (en) | 1989-12-26 | 1991-08-27 | Nippon Medical Supply Corp | Manufacture of glucose-containing steam-sterilized liquid and tool used therefor |
ES2056497T3 (en) | 1990-01-12 | 1994-10-01 | Nephro Medica Pharma | SOLUTION FOR INFUSION AND DIALYSIS CONTAINING BICARBONATE AND CALCIUM. |
US5112622A (en) | 1990-01-19 | 1992-05-12 | Kopp Klaus F | Intravenous solutions for influencing renal function and for maintenance therapy |
SE502414C2 (en) | 1990-05-28 | 1995-10-16 | Ljungqvist Olle Medical Ab | Use of glucose for preparation of solution for preoperative administration and infusion solution therefore |
SE505967C2 (en) | 1990-10-15 | 1997-10-27 | Gambro Ab | The respective method for preparing a medical solution, for example a dialysis solution |
JPH05105633A (en) | 1991-10-14 | 1993-04-27 | Shimizu Seiyaku Kk | Glucose preparation and its production |
US5827820A (en) | 1992-04-06 | 1998-10-27 | Baxter International Inc. | Aqueous peritoneal dialysis solution |
JP2811035B2 (en) | 1992-08-05 | 1998-10-15 | 株式会社大塚製薬工場 | Bicarbonate blended liquid and its container |
ATE196602T1 (en) | 1993-02-19 | 2000-10-15 | Schael Wilfried | METHOD FOR PREPARING BICARBONATE-CONTAINING DIALYZY FLUIDS FOR HEMODIALYSIS |
US6306836B1 (en) | 1994-01-21 | 2001-10-23 | Baxter International Inc. | Peritoneal dialysis solutions containing maltodextrins and amino acids |
JPH07252137A (en) | 1994-02-21 | 1995-10-03 | Terumo Corp | Saccharides-containing electrolyte solution |
EP0716607B1 (en) | 1994-07-01 | 2002-08-28 | Baxter International Inc. | Biochemically balanced peritoneal dialysis solutions |
JPH08131542A (en) | 1994-11-11 | 1996-05-28 | Baxter Kk | Peritoneum dialysing liquid conditioning solution set |
JPH08164199A (en) | 1994-12-14 | 1996-06-25 | Terumo Corp | Neutral peritoneal dialysate |
SE507052C2 (en) | 1995-08-08 | 1998-03-23 | Gambro Ab | Containers intended to contain sterile medical solution |
JPH0987182A (en) | 1995-09-27 | 1997-03-31 | Terumo Corp | Neutral peritoneal dialysis fluid |
JPH09110703A (en) | 1995-10-20 | 1997-04-28 | Material Eng Tech Lab Inc | Electrolyte infusion and vessel therefor |
JP3867174B2 (en) | 1996-05-10 | 2007-01-10 | 味の素株式会社 | Hemodialysis preparation |
FR2753099B1 (en) | 1996-09-06 | 2001-03-23 | Aguettant Lab | SOLUTIONS FOR INFUSION AND DIALYSIS AND THE PLASTIC RECEPTACLES CONTAINING THEM |
ZA978002B (en) | 1996-09-11 | 1998-03-02 | Baxter Int | Containers and methods for storing and admixing medical solutions. |
JPH10201821A (en) | 1997-01-23 | 1998-08-04 | Material Eng Tech Lab Inc | Container for medical treatment |
JP3213271B2 (en) | 1997-05-08 | 2001-10-02 | 株式会社新素材総合研究所 | Method for producing medical container containing medical solution containing carbonic acid component |
JPH114872A (en) | 1997-06-17 | 1999-01-12 | Material Eng Tech Lab Inc | Medical container |
JPH119659A (en) | 1997-06-23 | 1999-01-19 | Material Eng Tech Lab Inc | Medical vessel |
GB9714218D0 (en) | 1997-07-04 | 1997-09-10 | Allied Therapeutics Ltd | Peritoneal dialysis fluid |
AU740613B2 (en) | 1997-08-22 | 2001-11-08 | Ajinomoto Co., Inc. | Glucose-containing preparation |
DE19748290B8 (en) | 1997-10-31 | 2009-09-03 | Fresenius Medical Care Deutschland Gmbh | Solution for peritoneal dialysis |
SE512349C2 (en) * | 1997-11-28 | 2000-03-06 | Gambro Lundia Ab | Multi-chamber container for medical solution, procedure for preparation of medical solution for peritoneal dialysis and use of such container for preparation of medical solution |
US6309673B1 (en) | 1999-09-10 | 2001-10-30 | Baxter International Inc. | Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy |
US7678097B1 (en) * | 1999-11-12 | 2010-03-16 | Baxter International Inc. | Containers and methods for manufacturing same |
GR1003567B (en) | 2000-06-28 | 2001-04-10 | Newer advantageous single and stable amino-acidsbased bicarbonate solutions for peritoneal dialysis and hemodialysis |
-
2002
- 2002-01-11 US US10/044,234 patent/US7122210B2/en not_active Expired - Lifetime
- 2002-11-04 EP EP10075494.4A patent/EP2322237B1/en not_active Expired - Lifetime
- 2002-11-04 CA CA002440455A patent/CA2440455A1/en not_active Abandoned
- 2002-11-04 KR KR1020097003087A patent/KR20090023747A/en not_active Application Discontinuation
- 2002-11-04 EP EP02806438.4A patent/EP1465688B2/en not_active Expired - Lifetime
- 2002-11-04 CN CNA2007103053034A patent/CN101219151A/en active Pending
- 2002-11-04 WO PCT/US2002/035322 patent/WO2003059417A1/en active Application Filing
- 2002-11-04 AT AT02806438T patent/ATE539782T1/en active
- 2002-11-04 BR BR0208003-6A patent/BR0208003A/en not_active Application Discontinuation
- 2002-11-04 AU AU2002356899A patent/AU2002356899B2/en not_active Expired
- 2002-11-04 MX MXPA03008204A patent/MXPA03008204A/en active IP Right Grant
- 2002-11-04 JP JP2003559577A patent/JP4778681B2/en not_active Expired - Fee Related
- 2002-11-04 DK DK10075490.2T patent/DK2322236T4/en active
- 2002-11-04 DK DK02806438.4T patent/DK1465688T4/en active
- 2002-11-04 ES ES02806438T patent/ES2380430T5/en not_active Expired - Lifetime
- 2002-11-04 KR KR1020117013032A patent/KR20110067176A/en not_active Application Discontinuation
- 2002-11-04 ES ES10075494T patent/ES2841099T3/en not_active Expired - Lifetime
- 2002-11-04 DK DK10075494.4T patent/DK2322237T3/en active
- 2002-11-04 ES ES10075490T patent/ES2395369T5/en not_active Expired - Lifetime
- 2002-11-04 KR KR10-2003-7011592A patent/KR20040078540A/en not_active Application Discontinuation
- 2002-11-04 CN CNB028063856A patent/CN100367942C/en not_active Expired - Fee Related
- 2002-11-04 KR KR1020107007897A patent/KR101119334B1/en not_active IP Right Cessation
- 2002-11-04 EP EP10075490.2A patent/EP2322236B2/en not_active Expired - Lifetime
- 2002-12-18 TW TW091136476A patent/TWI326597B/en not_active IP Right Cessation
-
2003
- 2003-01-06 AR ARP030100028A patent/AR038113A1/en unknown
-
2004
- 2004-11-11 HK HK04108898A patent/HK1065966A1/en not_active IP Right Cessation
-
2006
- 2006-09-12 US US11/531,121 patent/US20070003637A1/en not_active Abandoned
-
2008
- 2008-09-09 JP JP2008231401A patent/JP2008307404A/en active Pending
Patent Citations (38)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3878664A (en) * | 1972-11-27 | 1975-04-22 | Cybersol | Process for producing a therapeutic composition |
US4372100A (en) * | 1979-11-01 | 1983-02-08 | Baxter Travenol Laboratories, Inc. | Process and apparatus for compounding hyperalimentation solutions |
US4756838A (en) * | 1980-02-21 | 1988-07-12 | Veltman Preston Leonard | Preparation of dry dialysate products |
US4489535A (en) * | 1980-10-02 | 1984-12-25 | Veltman Preston Leonard | Materials and method for preparing dialysis solutions containing bicarbonate ions |
US4397392A (en) * | 1981-01-08 | 1983-08-09 | Intensive Technology, Inc. | Contained blood gas control |
US4465488A (en) * | 1981-03-23 | 1984-08-14 | Baxter Travenol Laboratories, Inc. | Collapsible multi-chamber medical fluid container |
US4761237A (en) * | 1981-07-10 | 1988-08-02 | Baxter Travenol Laboratories, Inc. | Peritoneal dialysis solution containing carbohydrate polymers |
US4879280A (en) * | 1981-09-24 | 1989-11-07 | Fresenius Ag | Dialysis solution for use in intraperitoneal dialysis |
US4396383A (en) * | 1981-11-09 | 1983-08-02 | Baxter Travenol Laboratories, Inc. | Multiple chamber solution container including positive test for homogenous mixture |
US4584176A (en) * | 1984-03-19 | 1986-04-22 | Oliver James C | Method and apparatus for storing bicarbonate dialysate |
US4630727A (en) * | 1984-04-06 | 1986-12-23 | Fresenius, Ag | Container for a bicarbonate containing fluid |
US4663166A (en) * | 1984-06-22 | 1987-05-05 | Veech Richard L | Electrolyte solutions and in vivo use thereof |
US5039609A (en) * | 1985-09-10 | 1991-08-13 | Research Technologies, Inc. | Osmotic agents for peritoneal dialysis |
US4959175A (en) * | 1987-01-27 | 1990-09-25 | Pierre Fabre Medicament | Solution for dialyses and use of peptides based on glycine for preparing it |
US4863714A (en) * | 1987-02-05 | 1989-09-05 | Cook Imaging Corporation | Sterilization of compositions of limited stability |
US5011826A (en) * | 1988-04-15 | 1991-04-30 | Fresenius Ag | Aqueous dialysis and rinsing solution for intraperitoneal administration |
US5211643A (en) * | 1989-05-26 | 1993-05-18 | Fresenius Ag | Sodium bicarbonate containing precipitate-free dialysis solutions |
US5122516A (en) * | 1989-05-26 | 1992-06-16 | Terumo Kabushiki Kaisha | Preparation for blood dialysis and method for production thereof |
US5092838A (en) * | 1989-11-30 | 1992-03-03 | Baxter International Inc. | Histidine buffered peritoneal dialysis solution |
US5141492A (en) * | 1991-05-13 | 1992-08-25 | Dadson Joseph E | Method and apparatus for performing peritoneal dialysis |
US5296242A (en) * | 1991-08-03 | 1994-03-22 | Rolf Zander | Aqueous solution and the use thereof |
US6139754A (en) * | 1991-11-15 | 2000-10-31 | Baxter International Inc. | Hemodialysis conductivity servo-proportioning system and method |
US5536469A (en) * | 1991-11-18 | 1996-07-16 | Gambro Ab | System employing a sterile medical solution containing glucose or glucose-like compounds and a solution intended for said system |
US5616248A (en) * | 1992-04-06 | 1997-04-01 | Schal; Wilfried | Method for the preparation of hemodialysis fluids containing bicarbonate |
US5423421A (en) * | 1992-05-03 | 1995-06-13 | Otsuka Pharmaceutical Factory, Inc. | Containers having plurality of chambers |
US5601730A (en) * | 1992-09-02 | 1997-02-11 | Pall Corporation | Process and apparatus for removal of unwanted fluids from processed blood products |
US5431496A (en) * | 1993-01-19 | 1995-07-11 | Baxter International Inc. | Multiple chamber container |
US5560403A (en) * | 1993-01-19 | 1996-10-01 | Baxter International Inc. | Multiple chamber container |
US5610170A (en) * | 1993-01-22 | 1997-03-11 | Otsuka Pharmaceutical Factory, Inc. | Package form for bicarbonate-containing powdery pharmaceutical compositions and a method of stabilizing the compositions |
US5383324A (en) * | 1993-04-23 | 1995-01-24 | Baxter International Inc. | Method for manufacturing and storing stable bicarbonate solutions |
US5509898A (en) * | 1993-05-10 | 1996-04-23 | Material Engineering Technology Laboratory, Inc. | Container for therapeutic use |
US5462526A (en) * | 1993-09-15 | 1995-10-31 | Mcgaw, Inc. | Flexible, sterile container and method of making and using same |
US5706937A (en) * | 1995-04-11 | 1998-01-13 | Nissho Corporation | Flexible dual-chambered container |
US5871477A (en) * | 1995-11-28 | 1999-02-16 | Material Engineering Technology Laboratory, Incorporated | Medical container with electrolyte solution stored therein |
US5945129A (en) * | 1996-08-01 | 1999-08-31 | Fesenius Medical Care Deutschland Gmbh | Process for the production of an infusion or dialysis solution containing bicarbonate |
US6013294A (en) * | 1997-05-30 | 2000-01-11 | The Procter & Gamble Company | Shelf-stable complete pre-mixes that are combinable to form ready-to-cook mixes or food beverage products |
US5853388A (en) * | 1997-08-21 | 1998-12-29 | Semel; David | Intravenous bag with separate compartment |
US7122210B2 (en) * | 2002-01-11 | 2006-10-17 | Baxter International Inc. | Bicarbonate-based solutions for dialysis therapies |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9249345B2 (en) | 2010-08-18 | 2016-02-02 | Fresenius Medical Care Deutschland Gmbh | Concentrate for medical solutions, production thereof and use thereof in dialysis |
US9527627B2 (en) | 2011-05-18 | 2016-12-27 | Fresenius Medical Care Deutschland Gmbh | Connector for dialysis container, container equipped with such connector, manufacturing and filling method for such connectors and containers |
US20140144794A1 (en) * | 2011-08-11 | 2014-05-29 | Fresenius Medical Care Deutschland Gmbh | Container for dialysis |
US10022299B2 (en) * | 2011-08-11 | 2018-07-17 | Fresenius Medical Care Deutschland Gmbh | Container for dialysis |
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US7122210B2 (en) | Bicarbonate-based solutions for dialysis therapies | |
US6475529B2 (en) | Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy | |
JP5690040B2 (en) | Bicarbonate-based peritoneal dialysis solution | |
US20060128658A1 (en) | Biocompatible dialysis fluids containing icodextrins | |
US7053059B2 (en) | Dialysis solutions with reduced levels of glucose degradation products | |
JP2009131668A (en) | Bicarbonate-based solution in single container | |
AU2008201009B2 (en) | Bicarbonate-based solutions for dialysis therapies |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: BAXTER HEALTHCARE S.A., SWITZERLAND Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BAXTER INTERNATIONAL INC.;REEL/FRAME:020022/0516 Effective date: 20021218 Owner name: BAXTER INTERNATIONAL INC., ILLINOIS Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BAXTER INTERNATIONAL INC.;REEL/FRAME:020022/0516 Effective date: 20021218 Owner name: BAXTER INTERNATIONAL INC., ILLINOIS Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ELISABETTINI, PAOLA;MENNEGUERRE, JEAN-PAUL;COLAS, JEROME;AND OTHERS;REEL/FRAME:020022/0142;SIGNING DATES FROM 20020306 TO 20020321 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- AFTER EXAMINER'S ANSWER OR BOARD OF APPEALS DECISION |