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Matched Legal Cases: ['Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03']

Patent US8136675 - Perm selective asymmetric hollow fibre membrane for the separation of toxic ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsThe present invention relates to a permselective asymmetric hollow fibre membrane for the separation of toxic mediators from blood, comprised of at least one hydrophobic polymer and at least one hydrophilic polymer. Further, the present invention relates to a process for the preparation of such a membrane,...http://www.google.com/patents/US8136675?utm_source=gb-gplus-sharePatent US8136675 - Perm selective asymmetric hollow fibre membrane for the separation of toxic mediators from bloodAdvanced Patent SearchPublication numberUS8136675 B2Publication typeGrantApplication numberUS 10/539,409Publication dateMar 20, 2012Filing dateDec 18, 2003Priority dateDec 20, 2002Also published asDE20321776U1, DE60334838D1, EP1572330A1, EP1572330B1, EP2281625A1, US8197745, US20060144782, US20120145631, WO2004056460A1Publication number10539409, 539409, US 8136675 B2, US 8136675B2, US-B2-8136675, US8136675 B2, US8136675B2InventorsReinhold Buck, Hermann GoehlOriginal AssigneeGambro Lundia AbExport CitationBiBTeX, EndNote, RefManPatent Citations (38), Non-Patent Citations (47), Referenced by (5), Classifications (26), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetPerm selective asymmetric hollow fibre membrane for the separation of toxic mediators from bloodUS 8136675 B2Abstract The present invention relates to a permselective asymmetric hollow fibre membrane for the separation of toxic mediators from blood, comprised of at least one hydrophobic polymer and at least one hydrophilic polymer. Further, the present invention relates to a process for the preparation of such a membrane, and the use of said membrane in hemodialysis, hemodiafiltration, and hemofiltration for treatment of toxic mediator-related diseases.
The invention claimed is: 1. A permselective asymmetric hollow fibre membrane for the separation of toxic mediators from blood, comprised of at least one hydrophobic polymer and at least one hydrophilic polymer, wherein said hydrophobic polymer is selected from the group consisting of polyarylethersulfone (PAES), polypropylene (PP), polysulfone (PSU), polymethylmethacrylate (PMMA), polycarbonate (PC), polyacrylonitrile (PAN), polyamide (PA), and polytetrafluoroethylene (PTFE), and wherein said membrane comprises a separation layer and the separation layer is the inner most layer of the hollow fibre membrane, and wherein said membrane allows passage of molecules having a molecular weight of 50,000 Daltons, with a sieving coefficient of about 0.7 in the presence of whole blood, has a sieving coefficient for IL-6 in the presence of whole blood of 0.9-1.0, and has a molecular weight exclusion limit of about 200,000 Daltons in water;
This application is a national stage application under 35 U.S.C. �371 of international application number PCT/SE2003/001993, filed Dec. 18, 2003, which claims the benefit of priority from Swedish application number 0203855-2, filed Dec. 20, 2002.
TECHNICAL FIELD OF THE INVENTION The present invention relates to a permselective asymmetric hollow fibre membrane for the separation of toxic mediators from blood, comprised of at least one hydrophobic polymer and at least one hydrophilic polymer. Further, the present invention relates to a process for the preparation of such a membrane, and the use of said membrane in hemodialysis, hemodiafiltration and hemofiltration for treatment of toxic mediator related diseases.
BACKGROUND OF THE INVENTION A significant number of patients in intensive care units die from a secondary complication known commonly as �sepsis� or �septic shock�. Medical illness, trauma, complication of surgery, and any human disease state, if sufficiently injurious to the patient, may develop into systemic inflammatory response syndrome (�SIRS�), multi-organ system dysfunction syndrome (�MODS�), and multi-organ system failure (�MOSF�).
The mechanism of SIRS is the excessive release of host derived inflammatory mediators, herein referred to as toxic mediators (�TM�). TM include various cytokines (tumor necrosis factor, TNF; the interleukins; interferon), various prostaglandins (PG I.sub.2, E.sub.2, Leukotrienes), various clotting factors (platelet activating factor, PAF), various peptidases, reactive oxygen metabolites, and various poorly understood peptides which cause organ dysfunction (myocardial depressant factor, MDF). If the inflammatory response is excessive, then injury or destruction to vital organ tissue may result in multiorgan dysfunction syndrome (�MODS�). Sepsis is the single most common cause of SIRS leading to MOSF.
Hemofiltration (�HF�) was developed as a technique to control overhydration and acute renal failure in unstable patients and may use a hemofilter consisting of a cellulose derivatives or synthetic membrane (e.g., polysulfone, polyamide, etc.) fabricated as either a parallel plate or hollow fibre filtering surface. Current HF membranes, when used to treat acute renal failure associated with MOSF have been associated with incidental improvements in organ function other than the kidneys. However, these membranes remain deficient in the treatment of MOSF because their specific design characteristics prevent them from removing TM in the upper molecular weight range of recognized TM.
SUMMARY OF THE INVENTION The object of the present invention is to provide an improved permselective asymmetric hollow fibre membrane for the separation of toxic mediators from blood, comprised of at least one hydrophobic polymer and at least one hydrophilic polymer.
BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the present invention will now be described in more detail, reference being made to the enclosed drawings, in which:
FIGS. 3 a and 3 b shows the sieving coefficients for two different membranes, a prior art standard �high flux membrane� and the membrane according to the invention,
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS The present invention provides a permselective asymmetric hollow fibre membrane for use in a method of treating a pathophysiological state by filtering and/or dialysing blood, comprising the steps of: withdrawing blood from a mammal; filtering and/or dialysing the blood; and returning said blood to the mammal. The methods of the present invention may use either continuous arteriovenous or continuous venovenous hemofiltration, hemodiafiltration or hemodialysis.
As used herein, the term �hemodialysis�, HD, refers to a process to correct the chemical composition of blood by removing accumulated metabolic products and adding buffer in a process of diffusion through a natural or synthetic semi-permeable membrane.
As used herein, the term �hemodiafiltration�, HDF, refers to a process to remove accumulated metabolic products from blood by a combination of diffusive and convective transport through a semi-permeable membrane of high-flux type; fluid is removed by ultrafiltration and the volume of filtered fluid exceeding the desired weight loss is replaced by sterile, pyrogen-free infusion solution.
As used herein, the term �hemofiltration�, HF, refers to a process of filtering blood by a membrane with separation of plasma water and solutes with the ultrafiltrate, and retaines all proteins larger than effective pore size and blood cells. In hemofiltration the accumulated metabolic products are removed from the blood by the process of convective transport as a consequence of ultrafiltration through a semi-permeable membrane of high-flux type; the volume of filtered fluid exceeding the desired weight loss is replaced by sterile pyrogen-free infusion solution.
As used herein, the term �ultrafiltrate� refers to the filtered plasma water and solute and molecules (including target peptides and proteins) smaller than effective pore size.
The term �hollow fibre membrane� used throughout the application text is intended to cover everything from one single hollow fibre up to several single hollow fibres and one or more bundles of such hollow fibres, each fibre having a filtrate side and a blood side.
The term �flat sheet membrane� used throughout the application text means a micropore containing flat membrane having a filtrate side and a blood side.
As used herein, the term �Toxic Mediators�, TM, refers to a heterogeneous group of chemicals synthesized and released by human tissue. TM include the inflammatory mediators of SIRS (cytokines, prostaglandins, oxygen metabolites), various clotting factors, various peptidases and various toxic peptides. The molecular weight range of known TM is 1,000-60,000.
As used herein, the term �hemofilter�, refers to the filter used in hemofiltration. It is configured as either a series of parallel plates or as a bundle of hollow fibres. The blood path is from a blood inlet port, through the fibres or between the plates, then to a blood outlet port. Filtration of blood occurs at the membrane with ultrafiltrate forming on the side of the membrane opposite the blood. This ultrafiltrate accumulates inside the body of the filter contained and embodied by the filter jacket. This jacket has an ultrafiltrate drainage port.
As used herein, the term �hemodialyser�, refers to the semi-permeable membrane used in hemodialysis. It is configured as either a series of parallel plates or as a bundle of hollow fibres. The blood path is from a blood inlet port, through the fibres or between the plates, then to a blood outlet port. A dialysate path is from a dialysate inlet port, outside the fibres or between the plates, the to a spent dialysate drain port. The dialysing of blood occurs at the membrane by diffusion through the membrane from the blood side to the dialysate side, and adding of buffer from the dialysate side to the blood side. The dialysate comprising necessary buffer and electrolytes.
As used herein, the term �extracorporeal circuit� refers to the system of plastic tubes attached to the hemofilter which is used clinically. The arterial line is the plastic tube which carries blood from artery or vein to the blood inlet port of the hemofilter. The venous line carries blood from the blood outlet port returning to a vein. The ultrafiltrate line carries ultrafiltrate from the ultrafiltrate drainage port on the filter jacket to a reservoir from which ultrafiltrate is discarded.
As used herein, the term �effective sieving coefficient (S)� refers to the physical property of a membrane to exclude or pass molecules of a specific molecular weight:
As used herein the term �cut off� refers to �nominal cut off� which means the molecular weight of a substance having a sieving coefficient (S) of 0.1 in water.
In FIG. 3 the sieving coefficients for two different membranes, a prior art standard �high flux membrane� and the high cut off membrane according to the invention are shown. In FIG. 4 the protein loss is illustrated. As may be seen from the figures the sieving coefficient of the membrane according to the present invention is superior to the high flux membrane and at the same time the loss of albumin is significantly lower in the membrane of the invention. According to a preferred embodiment of the invention the sieving coefficient for albumin in presence of whole blood is below 0.05.
In the present invention the polymer solution preferably is extruded through an outer ring slit of a nozzle having two concentric openings. Simultaneously a centre fluid is extruded through an inner opening of the nozzle. At the outlet of the spinning nozzle the centre fluid comes in contact with the polymer solution and at this time the precipitation is initialised. The precipitation process is an exchange of the solvent from the polymer solution with the nonsolvent of the centre fluid. Through this exchange the polymer solution inverses its phase from the fluid into a solid phase. In the solid phase there is built, by the kinetic of the solvent/nonsolvent exchange, the pore structure, i. e. asymmetry and the pore size distribution. The process works at a certain temperature which influences the viscosity of the polymer solution. According to the invention the temperature at the spinning nozzle and of the polymer solution and centre fluid is 30-80� C. The viscosity determines the kinetic of the pore forming process through the exchange of solvent with nonsolvent. Subsequently, the membrane is preferably washed and dried.
By the selection of precipitation conditions, e. g. temperature and speed, the hydrophobic and hydrophilic polymers are �frozen� in such a way that a certain amount of hydrophilic end groups are located at the surface of the pores and create hydrophilic domains. The hydrophobic polymer builds other domains. A certain amount of hydrophilic domains at the pore surface area are needed to avoid adsorption of proteins. The size of the hydrophilic domains should preferably be within the range of 20-50 nm. In order to repel albumin from the membrane surface the hydrophilic domains also need to be within a certain distance from each other. By the repulse of albumin from the membrane surface direct contact of albumin with the hydrophobic polymer is avoided and consequently the absorption of albumin.
In a preferred embodiment of the invention the polymer solution coming out through the outer slit openings is, on the outside of the precipitating fibre, exposed to a humid steam/air mixture. Preferably, the humid steam/air mixture has a temperature of at least 15� C., more preferably at least 30� C., and not more than 75� C., more preferably not more than 60� C.
EXAMPLES Example 1 A polymer solution is prepared by mixing 14 weight % of polyarylethersulfone, 0.5 weight % of polyamide, 8 weight % of PVP K30, 2 weight % of water and 75.5 weight % of NMP. A mixture of 52 weight % water and 48 weight % NMP serves as a centre and precipitation solution. The viscosity of the polymer solution, measured at a temperature of 22� C. is 4.5 Pas.
The centre and polymer solution are heated to 57� C. and pumped towards a 2-component hollow fibre spinneret. The polymer solution emerges from the spinneret through an annular slit with an outer diameter of 0.5 mm and an inner diameter of 0.35 mm. The centre solution emerges from the spinneret in the centre of the annular polymer solution tube in order to start the precipitation of the polymer solution from the inside and to determine the inner diameter of the hollow fibre.
At the same time the 2 components (polymer & centre solution) enters a space separated from the room atmosphere. This space is called spinning shaft. A mixture of steam (100� C.) and air (22� C.) is injected into the spinning shaft. The temperature in the spinning shaft is adjusted by the ratio of steam and air at 52� C. The relative humidity was adjusted to 98% and the solvent content was controlled to 4.5% by weight NMP related to water content. The length of the spinning shaft is 890 mm. By the aid of gravity and a motor-driven roller, the hollow fibre is drawn from top to bottom, from spinneret through the spinning shaft into a water bath in vertical direction. The spinning velocity is 15.0 m/min. The hollow fibre is subsequently led through a cascade of water bathes and temperatures increasing from 20 to 90� C. The wet hollow fibre membrane leaving the water rinsing bath is dried in a consecutive online drying step. After a texturising step, the hollow fibre is collected on a spinning wheel in the shape of a bundle. After introducing the bundle into a dialyser housing, it is potted with polyurethane, ends are cut, on both sides of the dialyser a header is fixed to the housing, the dialyser is rinsed with hot water and dried with air. During this last drying step, an amount of 19 g of residual water per m2 effective membrane area is left on the dialyser. The filter device contains 1.1 m2 effective membrane area. After labelling and packaging, the dialyser is steam-sterilized within the package in an autoclave at 121� C. for 25 min.
Example 2 (Comparative) Compared to example no. 1, only the following was changed in the composition of the polymer solution: 16% of polyarylethersulfone, 0.5% of Polyamide, 8% of PVP K30, 0% of water and 75.5% of NMP.
The polymer solution temperature was 46� C., and the spinning shaft temperature was 42� C.
Example 3 (Comparative) Compared to example no. 1, only the following was changed in the composition of the polymer solution: 14% of polyarylethersulfone, 0.5% of polyamide, 7% of PVP K30, 3% of water, and 75.5% of NMP.
The polymer solution temperature was 53� C., and spinning shaft temperature was 48� C.
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No. 10/539,409).47Zusammenhang zwischen Spinntemperatur und Durchl�ssigkeit f�r verschiedene Membranrezepturen (graph to demonstrate the spinning temperature effect), submitted during Oral Proceedings at European Patent Office for European Patent Application No. 03 781 225.2-2113, dated Jun. 10, 2010 (which is a member of the same patent family as U.S. Appl. No. 10/539,409).* Cited by examinerReferenced byCiting PatentFiling datePublication dateApplicantTitleUS8496122 *Dec 17, 2003Jul 30, 2013Gambro Lundia AbPermselective membrane and process for manufacturing thereofUS8528744 *Sep 26, 2008Sep 10, 2013Gambro Lundia AbHydrophilic membranes with a non-ionic surfactantUS20060234582 *Dec 17, 2003Oct 19, 2006Hermann GohlPermselective membrane and process for manufacturing thereofUS20090110900 *Apr 25, 2007Apr 30, 2009Toyo Boseki Kabushiki KaishaPolymeric porous hollow fiber membraneUS20100320146 *Sep 26, 2008Dec 23, 2010Bernd KrauseHydrophilic membranes with a non-ionic surfactant* Cited by examinerClassifications U.S. Classification210/500.23, 210/500.38, 210/500.43, 210/500.41, 210/500.36, 210/500.27, 210/500.42International ClassificationB01D69/08, D01D5/24, B01D39/14, B01D67/00, B01D33/21, A61M1/16, B01D39/00, A61M1/34Cooperative ClassificationB01D67/0006, B01D2325/02, B01D67/0002, A61M1/34, B01D69/08, A61M1/16, D01D5/24European ClassificationB01D69/08, B01D67/00K12, B01D67/00K, D01D5/24Legal EventsDateCodeEventDescriptionDec 29, 2011ASAssignmentOwner name: GAMBRO LUNDIA AB, COLORADOFree format text: RELEASE OF SECURITY INTEREST IN PATENTS;ASSIGNOR:CITICORP TRUSTEE COMPANY LIMITED, AS SECURITY AGENT;REEL/FRAME:027456/0050Effective date: 20111207May 21, 2009ASAssignmentOwner name: CITICORP TRUSTEE COMPANY LIMITED, UNITED KINGDOMFree format text: IP SECURITY AGREEMENT SUPPLEMENT;ASSIGNOR:GAMBRO LUNDIA AB;REEL/FRAME:022714/0702Effective date: 20090331Owner name: CITICORP TRUSTEE COMPANY LIMITED,UNITED KINGDOMFree format text: IP SECURITY AGREEMENT SUPPLEMENT;ASSIGNOR:GAMBRO LUNDIA AB;US-ASSIGNMENT DATABASE UPDATED:20100302;REEL/FRAME:22714/702Free format text: IP SECURITY AGREEMENT SUPPLEMENT;ASSIGNOR:GAMBRO LUNDIA AB;US-ASSIGNMENT DATABASE UPDATED:20100225;REEL/FRAME:22714/702Free format text: IP SECURITY AGREEMENT SUPPLEMENT;ASSIGNOR:GAMBRO LUNDIA AB;US-ASSIGNMENT DATABASE UPDATED:20100329;REEL/FRAME:22714/702Free format text: IP SECURITY AGREEMENT SUPPLEMENT;ASSIGNOR:GAMBRO LUNDIA AB;US-ASSIGNMENT DATABASE UPDATED:20100413;REEL/FRAME:22714/702Free format text: IP SECURITY AGREEMENT SUPPLEMENT;ASSIGNOR:GAMBRO LUNDIA AB;US-ASSIGNMENT DATABASE UPDATED:20100420;REEL/FRAME:22714/702Free format text: IP SECURITY AGREEMENT SUPPLEMENT;ASSIGNOR:GAMBRO LUNDIA AB;REEL/FRAME:22714/702Nov 29, 2005ASAssignmentOwner name: GAMBRO DIALYSATOREN GMBH, GERMANYFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BUCK, REINHOLD;GOEHL, HERMANN;REEL/FRAME:017276/0868Effective date: 20051026Owner name: GAMBRO LUNDIA AB, SWEDENFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:GAMBRO DIALYSATOREN GMBH;REEL/FRAME:017280/0879Effective date: 20051028RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google