|Publication number||US3825493 A|
|Publication date||Jul 23, 1974|
|Filing date||Sep 29, 1972|
|Priority date||Sep 29, 1972|
|Also published as||DE2321168A1, DE2321188A1|
|Publication number||US 3825493 A, US 3825493A, US-A-3825493, US3825493 A, US3825493A|
|Inventors||C Brown, M Frommer|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (41), Classifications (17), Legal Events (7)|
|External Links: USPTO, USPTO Assignment, Espacenet|
July 23, 1974 C BRQWN ETAL 3,825,493
PERI'I'ONEAL ARTIFICIAL KIDNEY Filed Sept. 29, 1972 RECON STITUT NG SOLUTION PRESSURE REGULATING VALVE METERING PUMP IMPLANTED PERITONEUM 26\- CATHETER 2 HIGH PRESSURE PUMP PERITONEAL CAVITY RECONSTITUTINGL SOLUTION MEMBRANE PERITONEAL FLUID United States Patent 3,825,493 PERITONEAL ARTIFICIAL KIDNEY Clinton E. Brown, Silver Spring, Md., and Moshe-Aharou Frommer, Rehovoth, Israel, assignors to Hydronautics, Incorporated. Laurel, Md.
Filed Sept. 29, 1972, Ser. No. 293,474 Int. Cl. B01d 31/00, 13/00 US. Cl. 210-23 7 Claims ABSTRACT OF THE DISCLOSURE A peritoneal artificial kidney in which a prepared solution is circulated through the peritoneal cavity and the resulting peritoneal fluid containing unwanted toxic metabolites is withdrawn from the cavity and passed through filtration means that permits essentially only passage of pure water while rejecting the metabolites. The filtered peritoneal fluid is then reconstituted with a controlled make-up solution for recycle to the peritoneal cavity and the rejected residue is discharged as waste.
This invention relates to artificial kidneys for removing toxic substances in the blood normally excreted through the human kidney, and more particularly, to a compact, wearable artificial kidney for removing the toxic substances by peritoneal dialysis.
In recent years, the development of artificial kidneys has prolonged the lives of human beings with damaged or inoperative kidneys. The physiology of the human kidney is fairly well understood and involves the removal of nonvolatile wastes from the blood stream and the continuous regulation of the blood composition such that the conditions in body tissues necessary for the life of cells are maintained. Accordingly, when the kidneys are not operating properly, these functions must be performed by artificial means to prevent any imbalance from developing and the build-up of toxic conditions in the blood.
A variety of artificial devices has been developed for assuming the function of a human kidney. Most commonly, these devices withdraw blood from the body and pass the blood through an external dialyzer to draw out or remove the undesired toxic substances from the blood and then the blood is returned to the body. When these devices are used for several hours, several times per week, they are capable of reducing the level of concentration of toxic substances in the blood to a safe level.
The dialysate or wash solution, however, must be carefully formulated so as to be isotonic to the blood and so that certain desirable constituents of the blood, such as electrolytes, are not lost in the dialysis procedure. The devices all commonly operate on an intermittent basis, requiring a high volume of dialysate and in turn necessitating a bulky and immobile reservoir for the solution. Further, the intermittent use of such devices causes the concentrations of toxic substances in the patients blood stream to oscillate from an abnormally high position just prior to treatment to a low point immediately following treatment. This creates undesirable side effects in the patients general condition. Finally, the fact that the blood is being used for the treatment involves the risk of clotting and anticoagulants must be utilized in the treatment.
Accordingly, more recent efforts in the field of artificial kidneys have been to develop devices that can operate independently of the blood and that can consistently maintain the concentration of toxic substances at an acceptable level. In order to provide a continuously operating kidney, of course, the devices must be portable and wearable by the patient and desirably compact, reliable, and of minimum discomfort.
In US. Pat. No. 3,799,873 of Clinton E. Brown, for
example, which patent is assigned to the assignee of the present invention, there is described a completely recirculating artificial kidney, suitable for use in removing toxic substances from the blood by peritoneal dialysis. The device operates on the well known technique of peritoneal dialysis, in which a prepared solution is circulated through the peritoneal cavity and the unwanted metabolites, such as urea, creatinine, uric acid, etc. are drawn into the solution by natural diffusion from the blood stream across the peritoneal membranes, resulting in what is commonly referred to as peritoneal fluid. This fluid now containing the unwanted toxic substances is removed from the body, and passed through an external dialyzer to remove the toxic substances from the peritoneal fluid, and the purified fluid is then returned to the peritoneal cavity. To provide a completely portable device, however, means are also provided for purifying, reconstituting, and re cycling the dialysate for the external dialyzer. In essence, the device comprises two recirculating loops; one for the body fluid and one for the dialysate.
While this represents a significant improvement in the art of developing wearable, compact, and efl'lcient artificial kidneys, it obviously involves more operations than the more common intermittent, but immobile, devices heretofore used to dialyze the blood. In accordance with the present invention, however, there is provided a much more simplified artificial kidney that requires only one recirculating loop like a blood dialysis device, but without the necessity of doing something with the spent dialysate that has heretofore plagued the development of a truly satisfactory mobile device. More specifically, it has been found that the need for an external circuit to cleanse the dialysate in order to provide a portable device can be eliminated by filtering the peritoneal fluid of its toxic substances and returning the filtered fluid after being reconstituted to the peritoneal cavity. Thus, in contrast to earlier intermittent devices where the dialysate is discarded, or portable devices where the dialysate must be purified and recirculated, the device of the present invention filters the peritoneal fluid and returns it for further use.
As embodied and broadly described, therefore, this invention comprises circulating a prepared solution through the peritoneal cavity to withdraw toxic metabolites from the blood across the peritoneal membranes and into the solution forming peritoneal fluid; removing the peritoneal fluid from the peritoneal cavity; filtering the fluid to remove toxic substances from the peritoneal fluid; reconstituting and recycling the filtered fluid back to the peritoneal cavity; and discarding the rejected wastes.
Of the accompanying drawings:
FIG. 1 illustrates a schematic representation of the peritoneal artificial kidney of this invention; and
FIG. 2 is a suitable filter cell employing reverse osmosis membranes.
The artificial kidney of this invention is particularly adapted for use with peritoneal fluid. By peritoneal fluid is meant not only that fluid naturally existing in the peritoneal cavity, but the prepared conventional peritoneal dialysis solutions added to the cavity to supplement its volume. For a more thorough discussion of peritoneal dialysis for performing the function of a natural kidney and other examples of previous methods for performing recirculation peritoneal dialysis, reference is made to an article by J. H. Shinaberger, L. Shear and K. G. Barry, entitled Increasing Efiiciency of Peritoneal Dialysis," Transactions of American Society of Artificial Internal Organs, Vol. II, pages 76-82, 1965.
With reference to FIG. 1, peritoneal fluid 2 is withdrawn from conventional catheters 4, preferably of silicone rubber, implanted surgically in the peritoneum or peritoneal cavity and forced by the pumping action of a high-pressure pump 6 to the intake side 8 of a filtration means 10. Preferably, filtration means or filter cell 10 in cludes as the filter element 12 a membrane with hyperfiltration characteristics, such as reverse osmosis membranes, mounted within a suitable housing and having inlet means 14 for the peritoneal fluid, toxic metabolite eflluent means 16, both on the same side 8 of the filtration element 12, and a purified filtrate outlet means 18. Cell ber of alternative devices having hyperfilter characteristics that were used to cleanse the dialysate for the external dialyzer.
Peritoneal fluid is fed to filter cell 10 under pressure and at a rate of from to 50 ml./min., where it travels through the cell with a motion parallel to the filtering element 12, emerging as a concentrated solution of low molecular weight solutes or metabolites, such as urea, creatinine, uric acid, and electrolytes from outlet 16. Pressure is maintained on the order of 400 to 600 p.s.i. to pro vide a pressure differential across membrane 12 in filter cell by pump 6, and pressure regulating valve 20 in the waste rejection line 22. Relief or regulating valve 20 is designed to permit a continuous flow of peritoneal fluid through filter cell 10 and a continuous flow of wastes 22 to a urinal 24.
In the usual peritoneal dialysis treatment, Water is also removed in the peritoneal fluid. This is accomplished by providing the solution fed to the peritoneal cavity with sorbitol or a sugar, such as dextrose, to produce an osmotic pressure difference between the body and the solution, causing a flow of water across the peritoneal membranes 1 and into the solution forming peritoneal fluid. Generally,
the metabolites and electrolytes do not pass through membrane 12, but are rejected, and essentially only pure water tion may be added to the filtrate after it leaves filter cell 10 or, preferably, and as schematically shown in FIG. 1, is added at 19 to the low pressure side 26 of cell 10 and at the opposite end of the cell from peritoneal fluid inlet 14 so that its flow is countercurrent to the flow of peritoneal fluid. By this arrangement, the osmotic pressure of the solution can be used to also assist in the flow of water through membrane 12 of the filter cell.
The reconstituted water 28 is recycled back to the peritoneum through suitable catheters for further removal of toxic substances by peritoneal dialysis.
High pressure pump 6 and metering pump 32 are preferably cam driven by a suitable electric motor which is in turn powered by a portable, re-chargeable battery to pro- 1' vide a convenient wearable system. The pump and metering system are conventional and are more fully described in the above-mentioned patent.
Thus, the present invention provides a wearable, yet compact, artificial kidney uitable for use with peritoneal dialysis that recovers, filters, and reconstitutes peritoneal fluid in use and that requires only a small volume of fluid and a single recirculating loop. Of course, it is to be recognized that it is within the scope of this invention to modify the nature of the power source needed to operate the pump, and any source of power, portable or non-portable, could be used with the invention. Many other modifications are also possible, including fail-safe features to protect against punctures, leaks, ruptures in the fluid lines as well as clogging of the filters, sensing devices to sense the concentration of toxic substances in the recycled peritoneal fluid and the accumulation of waste in the urinal as well as automatic shut-01f and warning devices to alert the patient of any malfunction and the need for service to the system. The invention, therefore, is not limited to the specific details shown and described and departures may be made from such details without departing from the principles of the invention and without sacrificing its chief advantages.
What is claimed is:
. 1. A portable and wearable artificial kidney for continuously removing toxic metabolites from the blood comprising means for continuously circulating a prepared solution through the peritoneal cavity to draw toxic metabolites from the blood across the peritoneal membranes and into the fluid in the cavity forming peritoneal fluid; filtration means for continuously removing the toxic metabolites from the peritoneal fluid; means for continuously conveying the peritoneal fluid from the peritoneal cavity to the filtration means; means for continuously, recycling purified filtrate from the filtration means back to the peritoneal cavity; and means for reconstituting the recycled peritoneal fluid to make it suitable for re-use in the peritoneal cavity.
2. The kidney of claim 1, wherein the filtration means comprises a plurality of membranes with hyperfiltration characteristics and means for pressurizing the peritoneal fluid conveyed to the membranes to provide a pressure differential across the membrane.
3. The kidney of claim 2, wherein the filtration means includes a housing having peritoneal fluid inlet means and toxic metabolite eflluent means on the high pressure side of the membranes and purified filtrate outlet means on the low pressure side of the membranes.
4. The kidney of claim 2, wherein the housing also includes reconstituting fluid inlet means for introducing make-up solution to the low pressure side of the membranes in countercurrent flow to the flow of peritoneal fluid on the high pressure side of the membrane.
5. A method for continuously removing toxic metabolites from the blood, comprising continuously circulating a prepared solution through the peritoneal cavity to draw toxic metabolites from the blood across the peritoneal membranes and into the solution forming peritoneal fluid, continuously withdrawing the peritoneal fluid from the cavity, continuously filtering the fluid to remove the toxic metabolites, reconstituting and continuously recycling the filtered fluid to the peritoneal cavity for further use, and withdrawing and discharging the rejected residue as waste.
6. The method of claim 5, wherein the filtered fluid is reconstituted by the addition of a control solution of make-up electrolytes and sorbitol or a sugar.
7. The method of claim 5, wherein the peritoneal fluidis filtered by pressurizing the fluid and forcing it through membranes with hyperfiltration characteristics.
References Cited UNITED STATES PATENTS 3,506,126 4/1970 Serfass et al. 210-96 3,579,441 5/1971 Brown 210321 X 3,545,438 12/1970 De Vries 210-321 X 3,483,867 12/ 1969 Markovitz 210-23 X 3,619,423 11/1971 Galletti et al. 21022 FRANK A. SPEAR, JR., Primary Examiner US. Cl. X.R. 2l0321
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US4190047 *||Aug 26, 1977||Feb 26, 1980||University Of Utah||Method and apparatus for peritoneal dialysis|
|US4204957 *||Nov 4, 1976||May 27, 1980||Sartorius Membranfilter Gmbh||Artificial kidney|
|US4233434 *||May 9, 1978||Nov 11, 1980||Ramot Plastics||Polyamide from aromatic phosphorus containing diamine|
|US4244816 *||Jan 22, 1979||Jan 13, 1981||Exxon Research & Engineering Co.||Liquid membrane capsule systems resistant to coalescence by means of an irreversible coating|
|US4276175 *||Jul 19, 1979||Jun 30, 1981||Bower John D||Regeneratable peritoneal dialysis bag|
|US4311587 *||Dec 10, 1979||Jan 19, 1982||Japan Foundation For Artificial Organs||Filter arrangement denying bacteria entry to peritoneum|
|US4312755 *||Jun 29, 1979||Jan 26, 1982||Dow Corning Corporation||Reverse osmosis system|
|US4338190 *||Feb 8, 1977||Jul 6, 1982||A. T. Ramot Plastics Ltd.||Peritoneal artificial kidney|
|US4392960 *||Jan 27, 1976||Jul 12, 1983||A. T. Ramot Plastics, Ltd.||Process for the removal of urea from aqueous solutions|
|US4832684 *||Jun 11, 1987||May 23, 1989||Popovich Robert P||Peritoneal membrane plasmapheresis|
|US6527735 *||Apr 27, 2000||Mar 4, 2003||Renaltech International Llc||Method of peritoneal dialysis|
|US6758975||Feb 14, 2002||Jul 6, 2004||Piedmont Renal Clinic, Pa||Automated peritoneal dialysis system and process with in-line sterilization of dialysate|
|US7153286||May 24, 2002||Dec 26, 2006||Baxter International Inc.||Automated dialysis system|
|US7208092||Jul 17, 2003||Apr 24, 2007||Baxter International Inc.||Systems and methods for peritoneal dialysis|
|US7789849||Sep 7, 2010||Baxter International Inc.||Automated dialysis pumping system using stepper motor|
|US7815595||Oct 19, 2010||Baxter International Inc.||Automated dialysis pumping system|
|US7867214||Jan 11, 2011||Baxter International Inc.||Systems and methods for performing peritoneal dialysis|
|US7922686||Apr 12, 2011||Baxter International Inc.||Systems and methods for performing peritoneal dialysis|
|US7922911||May 29, 2009||Apr 12, 2011||Baxter International Inc.||Systems and methods for peritoneal dialysis|
|US8206338||Jun 26, 2012||Baxter International Inc.||Pumping systems for cassette-based dialysis|
|US8357113||Jan 22, 2013||Baxter International Inc.||Systems and methods for performing peritoneal dialysis|
|US8403880||Mar 26, 2013||Baxter International Inc.||Peritoneal dialysis machine with variable voltage input control scheme|
|US8529496||Jun 9, 2010||Sep 10, 2013||Baxter International Inc.||Peritoneal dialysis machine touch screen user interface|
|US8597227||Aug 19, 2011||Dec 3, 2013||Baxter International Inc.||Weight/sensor-controlled sorbent system for hemodialysis|
|US8715221||Mar 8, 2006||May 6, 2014||Fresenius Medical Care Holdings, Inc.||Wearable kidney|
|US8777892||Nov 2, 2009||Jul 15, 2014||Fresenius Medical Care Holdings, Inc.||Portable peritoneal dialysis system|
|US8815095||Sep 18, 2009||Aug 26, 2014||Baxter International Inc.||Peritoneal dialysis systems and methods that regenerate dialysate|
|US8998839||Dec 18, 2012||Apr 7, 2015||Baxter International Inc.||Systems and methods for performing peritoneal dialysis|
|US9078969||Sep 1, 2010||Jul 14, 2015||Fresenius Medical Care Holdings, Inc.||Peritoneal dialysis system|
|US20040019320 *||Jul 17, 2003||Jan 29, 2004||Childers Robert W.||Systems and metods for performing peritoneal dialysis|
|US20040082903 *||Jul 17, 2003||Apr 29, 2004||Micheli Brian R.||Systems and methods for peritoneal dialysis|
|US20070213665 *||Mar 8, 2006||Sep 13, 2007||Conor Curtin||Wearable kidney|
|US20090264812 *||Oct 22, 2009||Baxter International Inc.||Systems and methods for peritoneal dialysis|
|US20100010429 *||Jan 14, 2010||Baxter International Inc.||Systems and methods for performing peritoneal dialysis|
|US20100051552 *||Aug 28, 2008||Mar 4, 2010||Baxter International Inc.||In-line sensors for dialysis applications|
|US20100114012 *||Nov 2, 2009||May 6, 2010||Sandford Harold F||Portable Peritoneal Dialysis System|
|US20110060273 *||Sep 1, 2010||Mar 10, 2011||Fresenius Medical Care Holdings, Inc.||Peritoneal dialysis system|
|DE2903894A1 *||Feb 1, 1979||Aug 2, 1979||Exxon Research Engineering Co||Blutdialyseverfahren und vorrichtung zur durchfuehrung des verfahrens unter verwendung von stabilisierten fluessig- membrankapseln|
|DE19540079A1 *||Oct 27, 1995||Apr 30, 1997||Joachim Dr Med Boehler||Dialysis device with haemodialyser|
|DE19540079C2 *||Oct 27, 1995||Jun 21, 2000||Joachim Boehler||Dialysegerät|
|EP1480690A2 *||Dec 10, 2002||Dec 1, 2004||National Quality Care, Inc.||Wearable peritoneal dialysis system|
|U.S. Classification||604/28, 210/195.2, 210/321.71, 604/29, 210/321.8|
|International Classification||A61M1/00, A61M1/28, A61M1/16|
|Cooperative Classification||A61M1/28, A61M1/1696, B01D61/243, B01D61/28, A61M2001/281|
|European Classification||A61M1/16R2, A61M1/28, B01D61/24B, B01D61/28|
|Dec 27, 1991||AS||Assignment|
Owner name: TRACOR, INC.
Free format text: RELEASED BY SECURED PARTY;ASSIGNOR:BANK OF AMERICA NATIONAL TRUST AND SAVINGS ASSOCIATION AS COLLATERAL AGENT;REEL/FRAME:005957/0562
Effective date: 19911220
Free format text: RELEASED BY SECURED PARTY;ASSIGNOR:BANK OF AMERICA NATIONAL TRUST AND SAVINGS ASSOCIATION AS COLLATERAL AGENT;REEL/FRAME:005957/0542
Free format text: RELEASED BY SECURED PARTY;ASSIGNOR:BANK OF AMERICA NATIONAL TRUST AND SAVINGS ASSOCIATION;REEL/FRAME:005953/0942
Effective date: 19911227
|Dec 19, 1989||AS||Assignment|
Owner name: BANK OF AMERICA NATIONAL TRUST AND SAVINGS ASSOCIA
Free format text: SECURITY INTEREST;ASSIGNOR:TRACOR HOLDINGS, INC., TRACOR, INC., AND OTHERS INDICATED ON SCHEDULE SA;REEL/FRAME:005317/0726
Effective date: 19891030
|Dec 13, 1989||AS||Assignment|
Owner name: BANK OF AMERICA AS AGENT
Free format text: SECURITY INTEREST;ASSIGNOR:TORONTO-DOMINION BANK, THE;REEL/FRAME:005197/0122
Effective date: 19880801
Owner name: BANK OF AMERICA NATIONAL TRUST AND SAVINGS ASSOCIA
Free format text: SECURITY INTEREST;ASSIGNOR:TRACOR INC.;REEL/FRAME:005217/0224
Owner name: TORONTO-DOMINION BANK, THE
Free format text: SECURITY INTEREST;ASSIGNORS:TRACOR, INC.;LITTLEFUSE, INC.;TRACOR AEROSPACE, INC.;AND OTHERS;REEL/FRAME:005234/0127
Free format text: SECURITY INTEREST;ASSIGNOR:TRACOR, INC.;REEL/FRAME:005217/0247
Free format text: SECURITY INTEREST;ASSIGNORS:TORONTO-DOMINION BANK;TRACOR, INC.;REEL/FRAME:005224/0276
|Dec 22, 1987||AS06||Security interest|
Owner name: TORONTO-DOMINION BANK, THE, AS AGENT
Effective date: 19871216
Owner name: TRACOR, INC.,
|Dec 22, 1987||AS||Assignment|
Owner name: TORONTO-DOMINION BANK, THE, AS AGENT
Free format text: SECURITY INTEREST;ASSIGNOR:TRACOR, INC.,;REEL/FRAME:004810/0246
Effective date: 19871216
|Oct 27, 1983||AS||Assignment|
Owner name: TRACOR HYDRONAUTICS
Free format text: CHANGE OF NAME;ASSIGNOR:T-HYDRONAUTICS, INC.;REEL/FRAME:004186/0077
Effective date: 19830429
|May 20, 1983||AS||Assignment|
Owner name: T-HYDRONAUTICS, INC., 6500 TRACOR LANE AUSTIN, TX
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNOR:HYDRONAUTICS, INCORPORATED A CORP. OF MD;REEL/FRAME:004134/0357
Effective date: 19830509
Owner name: T-HYDRONAUTICS, INC., A CORP. OF TX, TEXAS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:HYDRONAUTICS, INCORPORATED A CORP. OF MD;REEL/FRAME:004134/0357