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WO2009083011A2 - Procédé de régénération de liquide de dialyse - Google Patents

Procédé de régénération de liquide de dialyse Download PDF

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Publication number
WO2009083011A2
WO2009083011A2 PCT/EG2007/000042 EG2007000042W WO2009083011A2 WO 2009083011 A2 WO2009083011 A2 WO 2009083011A2 EG 2007000042 W EG2007000042 W EG 2007000042W WO 2009083011 A2 WO2009083011 A2 WO 2009083011A2
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WO
WIPO (PCT)
Prior art keywords
fluid
dialysis
membrane
osmosis
urea
Prior art date
Application number
PCT/EG2007/000042
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English (en)
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WO2009083011A3 (fr
WO2009083011A4 (fr
Inventor
Khaled Mohamed Talaat Mohamed Fahim
Original Assignee
Mohamed Fahim Khaled Mohamed T
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Publication date
Application filed by Mohamed Fahim Khaled Mohamed T filed Critical Mohamed Fahim Khaled Mohamed T
Priority to PCT/EG2007/000042 priority Critical patent/WO2009083011A2/fr
Publication of WO2009083011A2 publication Critical patent/WO2009083011A2/fr
Publication of WO2009083011A3 publication Critical patent/WO2009083011A3/fr
Publication of WO2009083011A4 publication Critical patent/WO2009083011A4/fr

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/58—Multistep processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1694—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid
    • A61M1/1696—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid with dialysate regeneration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/02—Reverse osmosis; Hyperfiltration ; Nanofiltration
    • B01D61/025—Reverse osmosis; Hyperfiltration

Definitions

  • Renal failure is a condition in which advanced kidney disease causes the body to lose the ability to excrete harmful metabolites, maintain normal volume of body fluids, and control electrolyte and hydrogen ion concentrations within physiological ranges.
  • Dialysis is used to replace kidney function.
  • the patient's blood passes through a dialyzer which is a semi-permeable membrane that intervenes between the patient's blood and a large volume of externally-supplied dialysate composed of an electrolyte solution whose osmolarity and composition are very similar to the physiological osmolality and composition of the extracellular fluid.
  • Therapeutic dialysis is in essence a simple diffusion process that occurs across the membrane of the dialyzer whereby the uremic toxins dialyze out of the blood through the semi-permeable membrane into the ⁇ dialyzate and meanwhile the electrolytes of the patient's blood is brought to a near physiological concentration through simple diffusion down their concentration gradients across the membrane of the dialyzer.
  • a large volume of dilyzate must circulate through the dialyzer and then be discarded to maintain an effective concentration gradient to drive a useful rate of diffusion.
  • Ultrafiltration is a process of mass transfer of water and solutes across the membrane of the dialyzer. The driving force of ultrafiltration is a pressure difference applied across the dialyzer. Ultrafiltration is usually done during the session of dialysis. Ultrafiltration is an important component of the clinical prescription of dialysis because it removes the excess fluid volume accumulated in the patient's body during the interdialytic interval which otherwise would result in hypertension, edema and ultimately heart failure.
  • Peritoneal dialysis is another form of dialysis therapy in which a sterile, hypertonic dialysis solution is introduced into the patient's peritoneal cavity.
  • the peritoneal membrane acts as a natural dialyzer. Toxic uremic substances and various ions diffuse across the patient's peritoneum down their osmotic gradients.
  • the dialysis solution is intermediately drained and replaced with fresh dialysis solution.
  • Peritoneal dialysis requires draining, discarding and replacing large volumes of solution per day to achieve the needed clearance of uremic toxins.
  • the need to prepare large volumes of dialysis fluid with tightly controlled composition and the strict patient safety requirements led to the use of costly, bulky, and difficult to maintain and operate water treatment systems and dialysis machines.
  • the need for a considerable volume of specially treated water to reconstitute the dialysate is the major obstacle against developing implantable, wearable and portable dialysis devices.
  • the original Redy Sorbet system (Blumenkrantz et al., Artificial Organs 3(3):230-236, 1978) consists of a sorbet cartridge having five layers through which the spent dialysis solution containing uremic waste metabolites flows in order to be regenerated.
  • the first layer is a purification layer that removes heavy metals (i.e., copper and lead) and oxidants (i.e., chlorine and chloramines), an aluminum oxide layer bound to urease which degrades the urea in the dialysate into ammonium carbonate, a zirconium phosphate layer that adsorbs the ammonium ions produced from urea degradation along with other cations (i.e., potassium, magnesium and calcium), a hydrated zirconium oxide layer that exchanges phosphate and other anions (i.e., fluoride) for acetate and an activated carbon layer that absorbs other organic compounds (i.e., creatinine and uric acid).
  • heavy metals i.e., copper and lead
  • oxidants i.e., chlorine and chloramines
  • an aluminum oxide layer bound to urease which degrades the urea in the dialysate into ammonium carbonate
  • a zirconium phosphate layer that a
  • An alternative method to remove urea is to employ a bioreactor in which urea is degraded into ammonia by employing the urease enzyme and the generated ammonium ions are removed by electrodialysis. This process would necessarily require ammonium sensors to ensure that the highly toxic ammonia has been effectively removed prior to recirculation into the patient dialyzer.
  • U. S .Pat. Nos. 3,933,753 and 4,012,317 disclose alkenylaromatic polymers containing phenylglyoxal that can bind urea.
  • the phenylglyoxal polymeric material is made via acetylating performed in nitrobenzene followed by halogenation of the acetyl group and treatment with dimethylsulfoxide as disclosed in U.S. Pat. Nos. 3,933,753 and 4,012,317.
  • Another example of a polymeric material that is capable of selectively removing solutes, such as urea, from solution includes polymeric materials that contain a tricarbonyl functionality commonly known as ninhydrin as disclosed in U.S. Pat. No. 4,897,200.
  • U.S. patent No 2000703213665 a wearable artificial kidney for use with a continuous flow peritoneal system was described. This device requires the intermittent exchange of a dialyzate cleaning cassette and the concurrent oral administration of a urea binder.
  • Intravenous urea infusion experiments in healthy subjects revealed that high blood urea levels are associated with minimal symptoms.
  • blood urea levels similar to the usual levels found in patients with chronic renal failure were associated with minimal if any toxicity.
  • the sharks the physiological blood urea level is around 10 times the human level without any untoward effects.
  • urea is probably not a major uremic toxin, the current devices used for regeneration of dialysis fluid devote a great deal of their bulk and expense to ensure the safe removal of as much urea as possible.
  • Urea clearance is a good measure of dialysis efficiency in the classic dialysis therapies in which the used dialysate is not regenerated because urea clearance is then directly proportional to the clearance of the other uremic toxins. If the dilalysate is treated with a specific urea removing device before being recirculated, the clearance of urea will not be a good measure of the overall efficiency of the dialysis therapy. In dialysis systems using regenerated dialysis fluid, the ability to achieve separate control of urea clearance would have a clear advantage. Although the fluid used for hemodialysis and peritoneal dialysis can be regenerated, no device has yet been created that has the required efficiency and the small bulk necessary to be comfortably worn by the patient for prolonged time.
  • Jw is the water flux
  • A is the water permeability constant of the membrane
  • ⁇ is the reflection coefficient
  • P is the applied hydraulic pressure across the membrane
  • ⁇ is the osmotic pressure.
  • simple osmosis also known as forward osmosis
  • P is zero and consequently, water moves down the concentration gradient.
  • reverse osmosis P > ⁇ ; and the water flow is in the reverse direction i.e. from the side with higher concentration to the side of lower concentration.
  • Reverse osmosis is currently a widely used industrial process in the desalination and purification of water. It is also used in the industry for concentrating some solutions.
  • Simple osmosis also called forward osmosis, is a less commonly used process.
  • Hydration bags used to prepare sugary beverages from unsafe water by immersing bags made of special simple osmosis membrane in water are a popular application of simple osmosis.
  • a concentrated physiologically balanced solution to draw its own dilution water from the spent dialysis fluid across an osmosis membrane forming a regenerated toxin free fluid that can be further treated to provide a recycled dialysis fluid seems attractive, no device or method that uses this principle has been described. Disclosure of Invention BRIEF DESCRIPTION OF THE INVENTION
  • the present invention provides a method to extract a substantial portion of the water content of the spent dialysis fluid and the fluid extracted from the patient by ultrafiltration.
  • the extracted water directly dilutes a concentrate making its osmolarity more similar to the desired osmolarity of fresh dialysis solution.
  • the spent dialysis fluid is subjected to a simple osmosis treatment in which water is extracted down a concentration gradient across a water permeable but solute impermeable membrane to dilute a concentrated electrolyte solution that is circulated along the other side of the membrane.
  • an additional fraction of water is extracted from the spent dialysis fluid by a reverse osmosis process wherein the spent fluid is subjected to hydraulic pressure while it is circulated alongside a reverse osmosis membrane to obtain a low solute permeate and a more concentrated spent fluid which is discarded while the permeate is used to further dilute the concentrate.
  • exogenous water is added to obtain the desired osmolarity before using the obtained diluted concentrate as a fresh dialysis fluid.
  • uremic toxins are a diverse group of a large number of molecules with great heterogeneity in molecular weight and chemical structure, selective retrieval of water from the spent dialysis fluid if used in conjunction with a high efficacy dialyzer in an extended time dialysis treatment is able to achieve uniform clearance of the heterogeneous uremic toxins which are largely kept behind the osmosis membrane to the same degree regardless of their molecular weights and charge.
  • One feature of the present invention is the use of an independent method for complementary urea removal.
  • the urea sieving ability of the currently used osmosis membrane filters is at most 40-50%.
  • urea removal by binding to a urea binder or by an enzymatic method followed by ammonium adsorption is combined with the membrane treatment of the spent dialysis fluid.
  • the degree of delivered urea clearance can be controlled separately. Because the reported clinical toxicity attributable to urea per se is small and consists of easily recognizable gastrointestinal symptoms, the ability to control the degree of urea removal in separation from the total delivered dialysis dose has the advantage of reducing the cost of the whole process and decreasing the burden of carrying bulky equipment during the whole dialysis treatment time. This is particularly important when a wearable or portable dialysis system is used.
  • the current invention allows for the use of its different components in a variety of combinations that can be adapted to the patient's daily schedule so that the minimal bulk of equipment is carried on the patient when using the wearable unit of the system while, inside a portable unit, complementary spent dialysis fluid treatment is carried out separately. Exchange of the fluid between reservoirs mounted to the wearable unit and corresponding reservoirs in the portable unit is done upon brief connection of the two units.
  • a number made of three digits The first digit is the number of the figure to which the described feature relates while the second 2 digits is the number given to the feature itself.
  • the last 2 digits are the same if the particular feature are the same or are closely related in more than one figure.
  • the basic unit of the current invention is the osmosis unit.
  • the said osmosis unit consists of two fluid circuits separated by the simple osmosis membrane 101 and the reverse osmosis membrane 102.
  • the said spent dialysis fluid passes through the unit's inlet 103 through a pump 104 to the spent dialysis fluid side of the simple osmosis membrane 105 then through the reverse osmosis pump 106 then through the high pressure side of the reverse osmosis membrane 109 and finally to the exhaust fluid reservoir 108.
  • the permeate is re-directed from the permeate side of the reverse osmosis membrane 107 to the spent dialysis side of the simple osmosis unit 105.
  • the concentrate passes from its reservoir 110, to the concentrate side of the simple osmosis membrane 1 1 1, to a pump 1 12 which drives it through the outlet of the unit 113.
  • Water passes from the fluid in the first circuit to the second circuit across the simple osmosis membrane 101 down the concentration gradient, and across the reverse osmosis membrane 102 down the hydraulic pressure gradient to dilute the concentrate that is circulated in the second circuit.
  • Water from the exogenous water reservoir 114 is pumped by a controlled pump 115 to the spent dialysis fluid side of the simple osmosis membrane 105 where it passes down the concentration gradient to the concentrate side of the simple osmosis membrane 111.
  • the exogenous water from the water reservoir 1 14 is pumped to the high pressure side of the reverse osmosis membrane 109 (not shown in fig.1).
  • At least one conductivity sensor that controls the said exogenous water pump via an electronic feed back control loop (not shown in Fig 1) is incorporated.
  • the exogenous water need not be pre- treated with reverse osmosis as the osmosis membranes of the unit perform this form of treatment. However, the water should be pretreated with de-chlorination, filtration and softening to preserve the osmosis membranes.
  • the first is the exhaust fluid (to be discarded) consisting from highly concentrated spent dialysis fluid that was concentrated by extracting out a considerable proportion of its water by simple osmosis then by reverse osmosis.
  • the second fluid is the obtained diluted fluid obtained at the outlet of the unit 1 13 which consists of the concentrate diluted with: 1.
  • the exogenous water added to the spent dialysis fluid side of the simple osmosis membrane or the high pressure side of the reverse osmosis membrane.
  • simple osmosis treatment preceded the reverse osmosis process.
  • the spent dialysis fluid treatment may start with the reverse osmosis process followed by the simple osmosis process and the permeate resulting from the reverse osmosis process is then directly mixed with the fluid obtained on the concentrate side of the simple osmosis membrane distal to the reverse osmosis device.
  • An advantage of the said alternative arrangement is the decrease in the hydraulic pressure needed in the reverse osmosis unit because the concentration of the fresh spent dialysis fluid is substantially less than the feed fluid concentration if the spent dialysis fluid is treated first with simple osmosis.
  • the alternative arrangement comprises two fluid circuits separated by the reverse osmosis membrane 202 and the simple osmosis membrane 201.
  • the spent dialysis fluid passes through an inlet 203 to the high pressure side of the reverse osmosis membrane 209 then to the spent fluid side of the simple osmosis membrane 205 and finally to the exhaust fluid reservoir 208 while the concentrate passes from its reservoir 210 to the concentrate side of the simple osmosis membrane 21 1, then it is mixed with the permeate obtained in the permeate side of the reverse osmosis unit 207 after exiting the concentrate side of the simple osmosis unit.
  • a pump 212 drives the obtained diluted solution to exit the osmosis unit through its outlet 213.
  • a feed-back controlled pump 215 pumps exogenous water from the water reservoir 214 to the spent dialysis side of the simple osmosis membrane 205 or, alternatively, to the high pressure side of the reverse osmosis membrane 209 to achieve the desired osmolarity of the obtained diluted fluid
  • the concentrate should fulfill these requirements: 1. Its osmolarity should be high enough to effect meaningful water extraction from the spent dialysis fluid without the use of a big volume of the concentrate.
  • Sodium chlofide must be the major salt in the concentrate, because sodium and chloride are the main blood ions.
  • Other electrolytes e.g. calcium, magnesium and potassium are also essential for life. They must be added to the concentrate to obtain the prescribed dialysis fluid composition. Alternatively they may be directly added to the dialysis fluid.
  • the concentrate must be sterile and fulfill the requirements of solutions used for intravenous injection if the regenerated fluid is used for re-infusion in an ultrafiltration/re-infusion slow process dialysis prescription.
  • the obtained regenerated fluid may also be subjected to additional forms of treatment e.g. specific removal of phosphate, manipulation of pH and the addition of nutrients by adding additional devices.
  • additional forms of treatment e.g. specific removal of phosphate, manipulation of pH and the addition of nutrients by adding additional devices.
  • pretreatment of the spent dialysis fluid to decrease fouling and improve the performance of the osmosis membranes may be used.
  • the role of the reverse osmosis process is to extract more water from the spent dialysis fluid by using more energy in the form of external hydraulic pressure.
  • the osmotic treatment is done in two steps namely reverse osmosis and simple osmosis using two separate membranes each optimized for the particular process.
  • a special membrane for simple osmosis was developed by Hydration Technologies Inc. (HTI)). This proprietary membrane is thought to be made of cellulose triacetate (CTA). Its thickness is less than 50 ⁇ m while its structure is quite different from standard reverse osmosis membranes which typically consist of a very thin active layer (less than 1 ⁇ m) and a thick porous support layer.
  • the CTA (HTI) membrane lacks a thick support layer. Instead, the embedded polyester mesh provides mechanical support. In previous investigations, the CTA (HTI) was superior to the other reverse osmosis membranes in simple osmosis applications. Thinness of the CTA (HTI) membrane, its lack of a fabric support layer and its reduced internal concentration polarization are likely responsible for its superior performance. In the present invention, The CTA (HIT) membrane is chosen for use in the simple osmosis process because it has outperformed the other membranes tested for simple osmosis applications.
  • a CTA membrane with a total surface area of approximately 0.3 m 2 is enough to reach a near maximal equilibrium between the concentrate and the spent dialysis fluid.
  • a multi-layer (8-16 layers) flat sheet membrane in a frame and plate configuration was adopted. The said configuration was chosen because of the current popularity of flat sheet membranes in industry and their wide availability.
  • the said reverse osmosis membrane is chosen from the group of the commercially available reverse osmosis membranes. According to current practice, the chosen membrane must be able to withstand a hydraulic pressure of lpsi or more for each 100 ppm in the produced concentrate. Reverse osmosis may be accomplished in 1 to 4 membrane passes. Examples of suitable membranes include but are not limited to SW30-4040 and SW30-4021 membranes made by DOW-Filmtec, Minneapolis as well as Desal-SG2525TH membrane made by Osmonics.
  • urea removal by the simple osmosis membrane and the reverse osmosis membrane is suboptimal because urea is a small uncharged molecule.
  • the urea sieving ability of the currently used osmosis membrane filters is at most 40-50% of their sieving ability of most other uremic toxins.
  • a complementary method for the specific removal of urea was added to the other components of the current invention.
  • Urea may be removed by employing an enzymatic process in which a urease enzyme converts urea into ammonia and carbon dioxide.
  • the high toxicity of ammonia necessitates the use of a highly effective ammonium binder.
  • Electrodialysis may be used for the same purpose.
  • the current invention includes a urea removing unit able to deliver the desired complementary degree of urea clearance.
  • the urea removing unit comprises 2 fluid circuits separated by the membrane of the dialyzer of the urea removing unit 321.
  • the spent dialysis fluid that is to undergo the urea removing procedure is pumped by a pump 319 from the patient's dialyzer 318, to the first side of the urea removing unit dialyzer 322 then back to the patient's dialyzer.
  • a priming solution is circulated alongside the second side of the urea removing unit's dialyzer 320, by a pump 317 through the urea removing device 316, then back to the second side of the urea removing unit's dialyzer 320.
  • the urea removing unit dialyzer is a simple diffusion membrane similar to the group of the commercially available dialyzers used in hemodialysis.
  • the urea clearance of the chosen dialyzer and the flow rate in the " 2 fluid circuits in the urea removal unit determine the rate of transfer of urea across the dialyzer and consequently the rate of urea delivery to the urea removing device.
  • Dialyzer manufacturers provide the estimated clearance of their dialyzers at different blood flow rates as well as the KoA value which is the theoretical maximum urea clearance across the dialyzer in milliliter / minute at infinite flow rates of the blood and the dialysis fluid.
  • the urea clearance across the membrane will be slightly more than urea clearance in hemodialysis using the same membrane and the same fluid flow rates because of the slight decrease in urea clearance caused by the presence of red blood cells in the patient's blood in hemodialysis.
  • the effective urea distribution volume in the red blood cells is 80% while the plasma distribution volume of urea is 90%.
  • urea removing device urea is removed by either an enzymatic or a non enzymatic method as previously described.
  • This 2 fluid circuit design is twofold; first it allows for the independent setting of hydrostatic pressure and the fluid flow rate in each circuit. Second, it reduces the amount of lost blood and prevents contamination of the rest of the unit if a blood leak occurs across the patient's dialyzer.
  • This two circuit urea removing unit is used in isolation from the rest of the osmosis unit wherein the said urea removing unit is temporary attached to the patient's dialyzer, a high blood flow dialysis prescription is conducted and the spent dialysis solution is circulated through the said first fluid circuit of the urea removing unit wherein its urea is removed before pumping it back to the patient's dialyzer.
  • the pressure in the patient's blood compartment is kept higher than the pressure in the said second circuit to preserve the fluid volume in the urea removing unit.
  • the urea removing unit is detached from the patient's dialysis circuit. Further dialysis therapy is then conducted while the osmosis unit is attached to the patient's dialysis circuit in place of the urea removing unit and the patient's treatment is carried in 2 sequential steps. If this sequential therapy is used, the use of a high efficiency urea removing unit that is able to remove more than 60% of the daily produced urea within 1-2 hours is needed in order to keep the total treatment time within an acceptable limit.
  • the urea removing device may also be used to treat the fluid obtained from the osmosis unit before its reuse in the patient's dialysis where the obtained diluted concentrate produced in the osmosis unit is circulated through the urea removing device before its reuse in the patient's dialysis.
  • both urea removal and the main dialysis procedure are done simultaneously.
  • the current invention allows for the use of its components in different combinations allowing the therapy provider to tailor the therapeutic process to the particular needs of the individual patients.
  • the most obvious mode to use the current invention is to mount all its components: the osmosis unit 423, the urea removing device 416, together with their connecting tubing and fluid pump 417 to a portable frame and use it as a dialysis fluid regeneration unit to serve a simplified home dialysis machine.
  • the main advantage of using this system over the current home dialysis systems is the elimination of the need for exchangeable cartridges or pre-constituted dialysis fluid bags, the elimination of the need for special plumbing, and suitability for indoor ambulation.
  • all the components of the present invention together with an energy source e.g.
  • a rechargeable battery may be assembled into a wearable unit. Miniaturization of the components of the unit is both possible and desirable when this method is used because ambulation makes extended time dialysis prescription easily acceptable to many patients. A small unit operated for 12 hours per day needs to have only one sixth of the efficiency of a much bigger unit operated for 2 hours per day to achieve the same daily dialysis dose.
  • the said wearable unit comprises a dialysis unit 524 which is able to deliver an ultrafiltration rate up to 800 ml/ hour and dialyzate flow rate up to 3 liters/hour.
  • the spent dialysis fluid passes from the dialysis unit 524 to the osmosis unit 523 then through a pump 517 to the urea removing device 516 and finally back to the patient's dialysis unit 524 to be re-used in the patient's dialysis.
  • An example for the use of the said dialysis unit is given below:
  • the calculated dialysis fluid osmolarity will be 1.2 times the normal plasma osmolarity.
  • Dialysis fluid flow rate of approximately 2 liters / hour.
  • the drained exhaust fluid volume will be 0.75L / hour.
  • a lighter weight wearable unit For constructing a lighter weight wearable unit the components of the system are distributed into 2 units; a wearable unit and a portable unit.
  • the function of the wearable unit is to perform the patient's therapy with the minimal of equipment bulk and energy consumption while the portable unit is kept in the vicinity of the patient attached to a source of electric power.
  • the spent dialysis fluid undergoes treatment resulting in the production of regenerated fluid suitable for reuse in the patient's wearable unit.
  • Fluid reservoirs in the wearable unit and the portable unit keep suitable volumes of the spent dialysis fluid and the regenerated fluid respectively. Exchange of the fluid between reservoirs mounted to the wearable unit and corresponding reservoirs in the portable unit is done upon brief connection between the two units.
  • the wearable unit comprises only an ultrafiltration/re-infusion unit and 2 fluid reservoirs.
  • the said wearable ultrafiltration unit comprises a wearable or implantable filter 625 which is chosen from the group of filters with high ultrafiltration coefficient currently used for continuous hemofiltration therapy e.g. the F 40 hemo filter produced by Fresenius or the CA 210 produced by Baxter, a blood pump 633, an ultrafiltrate pump 634 and an ultrafiltrate reservoir 629.
  • the said ultrafiltrate reservoir is an approximately 1-3 liters reservoir attached with tubing to the ultrafiltrate side of the filter 626.
  • the patient's blood is pumped from a central vein or an arterio- venous fistula 628 to the blood side of the filter 627 then back to the venous access site 628.
  • no blood pump is needed.
  • a controlled hydraulic pressure difference is created across the filter by a pump 634 that creates negative pressure on the ultrafiltrate side of the filter 626.
  • Re-infusion solution is pumped from the regenerated fluid reservoir 630 by a pump 635 to the patient's blood distal to the blood filter.
  • Connection sites 631, 632 that fit with corresponding sites on the portable unit are fixed on the ultrafiltrate reservoir and the regenerated fluid reservoir.
  • the portable unit to be used with the said wearable ultrafiltration/re- infusion unit comprises an ultrafiltrate reservoir 729 that receives the ultrafiltrate from the wearable unit, the osmosis unit 723 a fluid pump 717 a urea removing device 716 and a regenerated fluid reservoir 730 connected with tubing in a fluid circuit. Connection sites 731,732 that fit with corresponding sites on the patient's unit are fixed on the ultrafiltrate reservoir and the regenerated fluid reservoir.
  • the patient's ultrafiltrate is subjected to simple osmosis, and reverse osmosis followed by a urea removal procedure. Finally, it is diluted with water to the desired osmolarity.
  • the regenerated solution is stored in the regenerated fluid reservoir 730 until exchanged for a new aliquot of the patient's ultrafiltrate upon the next attachment with the wearable unit.
  • the patient's treatment is carried out by combining high flow ultrafilration with post filter re- infusion according to the well established methods currently used in the practice of continuous slow renal replacement therapies.
  • the clearance of uremic toxins is achieved by conviction; a process in which the molecules dissolved in the patient's plasma is carried with the water of the ultrafiltrate.
  • the concentration of uremic toxins in the ultrafiltrate is nearly equal to their concentration in the patient's plasma. Consequently, from a practical point of view, the hourly clearance of uremic toxins will be equal to the volume of fluid exchanged per hour. If the treatment time is 12 hours per day and the exchanged volume is 2 liters every 120 minutes, a clearance of nearly 12 liters per day will be accomplished. The patient will have to carry 2 kilograms of fluid on person and to do the exchange process 6 times during the day.
  • An important feature of the present invention is the feasibility of combining different modes of therapy into the patient's treatment plan. For example, a 1 -2 hour separate urea removal can be combined with a 10 hour ambulatory dialysis therapy. Similarly, a short home dialysis prescription may be complemented with an ambulatory treatment using a wearable unit.
  • the present invention is also suitable for peritoneal dialysis fluid regeneration.
  • peritoneal dialysis regeneration When used for peritoneal dialysis regeneration, the use of a simple diffusion filter that prevents particulate matter and proteins from passage to the osmosis unit is necessary.
  • a simple diffusion filter very similar to the currently used hemodialysis filters can effectively prevent the passage of particulate matter and proteins.
  • the peritoneal dialysis fluid is re-circulated in the first fluid circuit from the patient's peritoneal cavity 836 with the aid of a pump 837 through a catheter to the first side of the simple diffusion filter 838 then back to the patient's peritoneal cavity 836 through another catheter or the second lumen of the peritoneal catheter if a double lumen peritoneal catheter is used.
  • a priming fluid is re-circulated in the second fluid circuit from the second side of the simple diffusion filter 839 with the aid of a pump 840, to the osmosis unit 823 then to the urea removing device 816 through a pump 817 then back to the second fluid path of the simple diffusion filter 839.
  • Fig. 1 represents the osmosis unit.
  • Fig .2 represents an alternative arrangement of the osmosis unit.
  • Fig .3 represents the urea removing unit.
  • Fig .4 represents the portable unit for dialysis fluid regeneration.
  • Fig.5 represents the wearable dialysis unit.
  • Fig. 6 represents the wearable ultrafiltration/re-infusion unit
  • Fig. 7 represents the portable unit for use with the wearable ultrafiltration/ re-infusion unit.
  • Fig. 8 represents a peritoneal dialysis fluid regeneration system.

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  • Separation Using Semi-Permeable Membranes (AREA)

Abstract

La présente invention se rapporte à un procédé d'extraction d'une quantité substantielle du contenu aqueux d'un liquide utilisé pour la dialyse. L'extraction se fait par une simple osmose durant laquelle l'eau est extraite suivant un gradient de concentration pour diluer une solution électrolytique concentrée, puis par une osmose inverse durant laquelle une quantité supplémentaire d'eau est extraite et utilisée afin de poursuivre la dilution du concentré et d'obtenir ainsi un liquide de dialyse régénéré. Un procédé complémentaire d'élimination de l'urée vient s'ajouter au traitement par osmose. En supprimant la nécessité d'utiliser une grande quantité d'eau exogène, la présente invention permet la construction d'unités de dialyse portables et mobiles.
PCT/EG2007/000042 2007-12-30 2007-12-30 Procédé de régénération de liquide de dialyse WO2009083011A2 (fr)

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WO2011031610A1 (fr) * 2009-09-08 2011-03-17 Fresenius Medical Care Holdings, Inc. Système de dialyse péritonéale
DE102012109858A1 (de) * 2012-10-16 2014-04-17 B. Braun Avitum Ag Dialyseoptimierungsverfahren
US8777892B2 (en) 2008-11-03 2014-07-15 Fresenius Medical Care Holdings, Inc. Portable peritoneal dialysis system
WO2013166038A3 (fr) * 2012-05-01 2015-06-18 Nidus Medical, Llc Drain péritonéal et perfusion
CN104826185A (zh) * 2015-03-11 2015-08-12 中国航天员科研训练中心 透析液再生装置
DK201400398A1 (en) * 2014-02-24 2015-11-30 Aquaporin As Systems for utilizing the water content in fluid from a renal replacement therapy process
EP2869911A4 (fr) * 2012-07-09 2016-05-11 Fosmo Med Inc Dispositifs utilisant une osmose directe médiée par membrane
WO2017021236A1 (fr) * 2015-08-06 2017-02-09 Fresenius Medical Care Deutschland Gmbh Unité d'ultrafiltration portative et dispositif d'alimentation de l'unité d'ultrafiltration en liquide de dialyse
EP3187211A1 (fr) 2015-12-31 2017-07-05 Fraunhofer Gesellschaft zur Förderung der angewandten Forschung e.V. Appareil et procédé de génération de dialysat pour dialyse
WO2017164722A1 (fr) * 2016-03-21 2017-09-28 Université Hassan Ii De Casablanca Dispositif portable pour hémodialyse
EP3272375A1 (fr) 2016-07-22 2018-01-24 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Appareil et procédé de génération de dialysat pour dialyse
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DE102018105120A1 (de) * 2018-03-06 2019-09-12 Fresenius Medical Care Deutschland Gmbh Vorrichtung und Verfahren zur Regeneration einer Dialyselösung
EP3579895A4 (fr) * 2017-02-07 2020-02-19 Victor Gura Systèmes de dialyse et méthodes associées
WO2020174097A1 (fr) * 2019-02-28 2020-09-03 Aquaporin A/S Production de dialysat usagé concentré
US10894118B2 (en) 2018-08-17 2021-01-19 University Of Washington Apparatus and method for urea photo-oxidation
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WO2021151875A1 (fr) * 2020-01-28 2021-08-05 Fresenius Medical Care Deutschland Gmbh Dispositif et procédé de production de dialysat
WO2021156429A1 (fr) * 2020-02-06 2021-08-12 Gambro Lundia Ab Système et procédé pour produire un fluide destiné à une dialyse péritonéale
WO2021156431A1 (fr) * 2020-02-06 2021-08-12 Gambro Lundia Ab Système et procédé de production de liquide de dialyse péritonéale
EP3868417A1 (fr) * 2020-02-18 2021-08-25 ICinnovation BV Dispositif vestimentaire et portable pour la dialyse à recirculation d'écoulement
WO2021167453A1 (fr) * 2020-02-18 2021-08-26 Icinnovation Bv Dispositif portatif et à porter sur soi pour dialyse à flux recirculant
CN113727745A (zh) * 2019-04-26 2021-11-30 东丽株式会社 透析液再生方法
WO2022214447A1 (fr) * 2021-04-09 2022-10-13 Gambro Lundia Ab Amorçage d'une unité d'osmose directe
JPWO2023100216A1 (fr) * 2021-11-30 2023-06-08
US12440614B2 (en) 2020-02-06 2025-10-14 Gambro Lundia Ab System and method for producing fluid for peritoneal dialysis

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US8777892B2 (en) 2008-11-03 2014-07-15 Fresenius Medical Care Holdings, Inc. Portable peritoneal dialysis system
AU2010292448C1 (en) * 2009-09-08 2015-08-13 Fresenius Medical Care Holdings, Inc. Peritoneal dialysis system
CN102481400A (zh) * 2009-09-08 2012-05-30 弗雷泽纽斯医疗保健控股有限公司 腹膜透析系统
JP2013503705A (ja) * 2009-09-08 2013-02-04 フレゼニウス メディカル ケア ホールディングス インコーポレイテッド 腹膜透析システム
WO2011031610A1 (fr) * 2009-09-08 2011-03-17 Fresenius Medical Care Holdings, Inc. Système de dialyse péritonéale
JP2014205051A (ja) * 2009-09-08 2014-10-30 フレゼニウス メディカル ケア ホールディングス インコーポレイテッド 腹膜透析システム
AU2010292448B2 (en) * 2009-09-08 2015-01-22 Fresenius Medical Care Holdings, Inc. Peritoneal dialysis system
US9078969B2 (en) 2009-09-08 2015-07-14 Fresenius Medical Care Holdings, Inc. Peritoneal dialysis system
WO2013166038A3 (fr) * 2012-05-01 2015-06-18 Nidus Medical, Llc Drain péritonéal et perfusion
EP2869911A4 (fr) * 2012-07-09 2016-05-11 Fosmo Med Inc Dispositifs utilisant une osmose directe médiée par membrane
DE102012109858A1 (de) * 2012-10-16 2014-04-17 B. Braun Avitum Ag Dialyseoptimierungsverfahren
US10293094B2 (en) 2014-02-24 2019-05-21 Aquaporin A/S Systems for utilizing the water content in fluid from a renal replacement therapy process
DK201400398A1 (en) * 2014-02-24 2015-11-30 Aquaporin As Systems for utilizing the water content in fluid from a renal replacement therapy process
DK179128B1 (en) * 2014-02-24 2017-11-20 Aquaporin As Systems for utilizing the water content in fluid from a renal replacement therapy process
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WO2017021236A1 (fr) * 2015-08-06 2017-02-09 Fresenius Medical Care Deutschland Gmbh Unité d'ultrafiltration portative et dispositif d'alimentation de l'unité d'ultrafiltration en liquide de dialyse
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WO2017164722A1 (fr) * 2016-03-21 2017-09-28 Université Hassan Ii De Casablanca Dispositif portable pour hémodialyse
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EP3272375A1 (fr) 2016-07-22 2018-01-24 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Appareil et procédé de génération de dialysat pour dialyse
US11000642B2 (en) 2016-07-22 2021-05-11 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Apparatus and method for generating dialysate for dialysis
EP3579895A4 (fr) * 2017-02-07 2020-02-19 Victor Gura Systèmes de dialyse et méthodes associées
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