US2880501A - Artificial kidney manufacture - Google Patents

Artificial kidney manufacture Download PDF

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Publication number
US2880501A
US2880501A US600076A US60007656A US2880501A US 2880501 A US2880501 A US 2880501A US 600076 A US600076 A US 600076A US 60007656 A US60007656 A US 60007656A US 2880501 A US2880501 A US 2880501A
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United States
Prior art keywords
blood
tubing
artificial kidney
manufacture
tubes
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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.)
Expired - Lifetime
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US600076A
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English (en)
Inventor
Henry E Metz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
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Baxter Laboratories Inc
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Filing date
Publication date
Priority to CA597994A priority Critical patent/CA597994A/en
Priority to BE558724D priority patent/BE558724A/fr
Application filed by Baxter Laboratories Inc filed Critical Baxter Laboratories Inc
Priority to US600076A priority patent/US2880501A/en
Application granted granted Critical
Publication of US2880501A publication Critical patent/US2880501A/en
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Expired - Lifetime legal-status Critical Current

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    • 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
    • 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
    • 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
    • B01D61/24—Dialysis ; Membrane extraction
    • B01D61/28—Apparatus therefor
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00—Surgery
    • Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49863—Assembling or joining with prestressing of part
    • Y10T29/4987—Elastic joining of parts

Definitions

  • This invention relates to a method of manufacturing an artificial kidney used in the treatment of human blood to remove therefrom deleterious substances present be cause of inoperation or malfunctioning of human kidneys.
  • the prime consideration in any artificial kidney is its foolproof operation, and, more especially, the complete integrity of the blood conduit. Presence of leaks in the permeable blood conduit render the device worthless. In the instance of the wound drum type of artificial kidney, it was generally impossible to determine the integrity of the permeable tube until after it was wound. Many other types of artificial kidneys cannot be effectively tested until just before use. It is to be noted that the testing is usually performed by filling the unit with blood since a unit filled with a fluid other than saline or blood could not be used for the dialysis, and since saline does not yield a visual discoloration of the rinsing fluid' to evidence a leak.
  • this invention permits the production of an artificial kidney so inexpensive and so easy to install that no proposed dialysis will be halted for the cost of an additional unit or the time to install one.
  • the criticality of a leakproof kidney can be especially appreciated when it is realized that a patient can bleed to death in a matter of minutes at the flow "ice rates employed: about 200 cc. per minute.
  • the integrity of the artificial kidney must be of the highest order since a given dialysis runs for a considerable period, four to five hours not being uncommon.
  • the artificial kidney structure to which my invention applies includes two flat cellulose tubes enveloped between nontoxic fiber glass screens.
  • the tubes and screening assembly is then tightly but uniformly coiled about itself and provided with suitable end connections leading from and to the body of the patient to be treated. Blood is pumped through the cellulose tubing while the rinsing fluid is pumped crosswise through the screening.
  • Fig. l is a schematic view of the portable artificial kidney system shown in operative condition
  • Fig. 2 is a cross-sectional view of the dialyzer portion of an artificial kidney
  • Fig. 3 is an enlarged view of a portion of Fig. 2
  • Fig. 4 is an enlarged, fragmentary, cross-sectional view of one of the connections between the blood conduits leading from and to the patient and the dialyzing membrane of the artificial kidney.
  • Fig. 1 a schematic view is shown of an artificial kidney system. Blood taken from an artery, such as the radial artery, is caused to flow into the dialyzer by pump BP.
  • pump BP blood pressure
  • at least two blood passageways are provided through the dialyzer. Use of a plurality of passageways through the dialyzer permits continued operation irrespective of unexpected leaks developing in one of the passageways as from the above-mentioned rough handling in shipment.
  • Entrance means are provided ahead of the pumps to permit the addition of priming blood and measurement of pressure within the artificial kidney system.
  • the introduction of priming blood is necessary to fill the unit before it is connected to the patient.
  • the blood pump designated BP
  • BP is a finger pump such as manufactured by Sigmamotor Co., of Middleport, New York. This pump operates externally to the conduit in which the blood flows and thereby eliminates the need for bothersome and costly cleaning of the system.
  • Use of this type of pump in which finger members F reciprocate sequentially against a positionable backing-plate to push blood along the conduits C permits achieving an equal flow in both membranes, irrespective of variations in resistance.
  • the pressurized blood is then delivered to the dialyzer in which it is contacted with a rinsing or dialyzing solution which generally includes saline and various other physiological salts and nutrients.
  • a preferred composition of dialyzing fluid includes per liter of water:
  • the dialyzing fluid which is circulated by a pump, designated SP, enters the dialyzer at the bottom of a cylindrical enclosure and overflows the top to return to the rinsing tank for recirculating.
  • the fluid is heated to about 39 C. and oxygenated (10% CO in 0 to maintain the blood in a favorable condition for reintroduction to the body.
  • the blood is conducted to a pair of air-trap-filter-drip units after which the two streams of blood are united and introduced into a. vein of the patient.
  • the air-trap-filterdrip units are equipped with vents V to exhaust any entrapped bubbles. Indicated by the letter I are joints in the conduits leading to and from the dialyzer permitting ready substitution of an alternate unit.
  • the dialyzer includes an open-topped outer enclosure H suitable for containing the dialyzing or rinsing fluid which is circulated by pump SP (seen in Fig. l), the path of the fluid being indicated by arrows in Fig. 2.
  • the operative portion of the dialyzer includes a pair of tubes constructed of a transparent, flexible, permeable membrane, the membrane permitting passage therethrough in either direction of ionic substances such as the above-mentioned saline or the deleterious urea contained within the blood but does not permit passage therethrough of larger molecules such as proteins, and, of course, blood cells.
  • the preferred embodiment has two layers of screening on one side of tubings and one on the other, the layers being maintained in spaced relation by four strip layers of similar screening inserted between the screening layers 11 as at 11a.
  • three thicknesses of screening will separate each convolution of tubing 10 so as not to unduly obstruct the flow of rinsing fluid.
  • the screening is sewn along its top and bottom edges and along its median to provide a perforate chambered, flat tubular housing or envelope for the two cellulose dialyzing tubes 10.
  • Inlet connections are made as at 13 and outlet connections as at 14, the structure of both connections being essentially that shown in larger scale in Fig. 4.
  • Fig. 4 The structure of Fig. 4 includes vinyl tubing 15 which refers to both the tubing leading from pump BP or the tubing leading to the air-trap-filter-drip units. I have found that these connections (tubing 15 to casings 10) are espectially critical in the manufacture of a leakproof dialyzer.
  • this tubing has a bore of about 0.140 inch and a wall thickness of about 0.035 inch.
  • rigid adapter 16 constructed of nylon in the pictured embodiment.
  • Adapter 16 has a somewhat larger O.D. than the ID. of tubing 15 so as to be held tightly therein.
  • the mounting of adapter 16 in tubing 15 is such that it extends a substantial distance external to tubing 15 and the extended portion thereof is covered by elastic sleeve 17; elastic sleeve 17 is constructed of rubber and is of somewhat smaller I.D. than the CD. of adapter 16 so as to be ensleeved on adapter 16 by a squeeze fit.
  • cellulose casing 18 Wrapped over tubing 17 is cellulose casing 18, being slightly larger than one inch in diameter in an expanded condition and of such thickness (approximately .001 inch) so as to lay flat, in which condition it has a width of about 1% inches.
  • casing 18 is wrapped uniformly about ensleeved adapter 16 so as to minimize stress since it is at this particular point that leaks are apt to occur. Loosely wrapped casing 18 is held in place thereon by elastic collar 19.
  • Elastic collar 19 in the preferred embodiment is similar to elastic sleeve 17, being constructed of rubber and having identical inner and outer diameters so as to achieve a tight squeeze-fit on casing 18.
  • Elastic collar 19 is readily assembled as shown by mounting it on tubing 15 over the unattached end provided with connector J.
  • a second elastic sleeve 20 Co-operating with elastic collar 19 in tightly securing casing 18 against elastic sleeve 17 is a second elastic sleeve 20 also assembled by ensleeving over tubing 15 from the free end equipped with joint J.
  • Sleeve 20 is constructed of rubber, but of smaller I.D. than sleeve 17 and collar 19 thereby securing casing 18 to sleeve 17 by a squeezing pressure uniform along the length of adapter 16 ensleeved with sleeve 17.
  • sleeve 20 is rolled on itself and mounted on tubing 15 before casing 18 is wrapped on elastic sleeve-equipped adapter 16. Thus, immediately after collar 19 is placed on casing 18 to hold it in place, the additional and uniform pressure of sleeve 20 can be brought to bear.
  • inelastic bands ,21 are placed over sleeve 20. Thread bands 21 are spaced apart, being on either side of collar 19.
  • a rubber-cellulose-rubher joint is effected which permits uniform compressive forces to be exerted on the permeable membrane, substantially eliminating the possibility of leakage. Also the formation of a joint connecting the ends of tubing 15 and casing 18 permits straight-through flow of blood that does not result in uneven stresses being applied to casing 18 during dialysis. A joint in the wall of casing 18 might produce such stresses that would result in rupture of casing 18 during the long period of dialysis.
  • the long tubing-screening assembly achieved as above is next dilated by momentarily applying air pressure of the order of 0.5 p.s.i. If this step is omitted, I have found that subsequent pressure testing when the assembly is coiled, produces tiny perforations in the cellulose housing.
  • the dialyzer unit In the manufacture of the dialyzer unit, a compact structure is provided out of the thirty-foot long assembly by winding screening 11 on itself around a cylinder 12. For optimum results this winding should be performed under constant tension. After rolling, the unit is pressuretested with air at a pressure of about 3% p.s.i., after which the unit is gas-sterilized and packaged to prevent contamination, sterile cotton being placed in the ends of tubing 15 at joints I.
  • the coil is maintained as such by suitable band or enclosure means about its circumference which are also designated to protect it during shipment.
  • the dialyzing tube is first fully wetted by causing rinsing fluid to flow. Then an electrolyte solution is pumped through the dialyzing tube to gradually distend it.
  • the salt content of the electrolyte solution is immaterial since it will quickly reach equilibrium with the dialyzing fluid. However, the last six liters of the electrolyte solution should be isotonic (i.e., 0.7% NaCl) and no air should be pumped into the kidney. If desired the dialyzer may be tested for leaks by pumping about 100 cc. of heparinized blood, followed by more saline. To this last saline a small quantity of heparin should be added.
  • the patient is canulated about an hour prior to connecting to the artificial kidney to minimize chances of clotting in the wounds.
  • the venous canula is inserted first, each canula containing saline and a small quantity of heparin, the venous connection being somewhat higher than the arterial connection to simulate resistance that may be encountered later in the vein.
  • the patient Prior to the arterial canulation, the patient is heparinized, (about mg. per average patient).
  • the artificial kidney is then primed with about a liter of citrated bank blood, also containing a small quantity of heparin.
  • the patients blood is then caused to flow through the kidney, the rate being determined by visual examination of the air-trap-filter-drip units and regulated by conventional tubing clamps. Heparin in small quantity is usually administered during the dialysis, the patients clotting time being checked from time to time.
  • a lay-flat, flexible, transparent, permeable tube between flat, nontoxic, perforate members arranged in spaced-apart, face-to-face relation, said tube and said members having lengths substantially greater than their widths, securing the longer edges of said members together to form a flat envelope for said tube, wrapping each end of said tube about a rigid tubular element connected to a length of resilient tubing, resiliently securing the wrapped ends of said tubes to said elements, temporarily dilating said tube, coiling said envelope about itself with the unattached ends of said lengths of tubing extending outward of the coiled envelope and securing said coiled envelope in a coiled condition, pressurizing said tube to test its integrity, and sterilizing the assembly thus achieved.
  • a method of artificial kidney manufacture the steps of introducing in spaced, edge-to-edge relation a pair of lay-fiat, flexible, transparent, permeable tubes between nontoxic, flat screen members arranged in spaced, face-to-face relation, said tubes and said members having lengths substantially greater than their Widths, securing the longer edges and median of said members together to form a flat chamber envelope for said tubes, wrapping the end of each tube about a portion of a rigid, tubular element, said element having been previously ensleeved with a tight-fitting sleeve of plastic material over the portion thereof to be wrapped with said tube and the remaining portion being inserted partway into a tight fitting length of resilient tubing, ensleeving the wrapped portion of said element with a second tight fitting sleeve of elastic material, banding said ensleeved, wrapped element portion to provide a leakproof joint, temporarily dilating said tubes, coiling said envelope about itself under constant tension with the unattached ends of said length

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  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Water Supply & Treatment (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • External Artificial Organs (AREA)
US600076A 1956-07-25 1956-07-25 Artificial kidney manufacture Expired - Lifetime US2880501A (en)

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Application Number Priority Date Filing Date Title
CA597994A CA597994A (en) 1956-07-25 Artificial kidney manufacture
BE558724D BE558724A (en, 2012) 1956-07-25
US600076A US2880501A (en) 1956-07-25 1956-07-25 Artificial kidney manufacture

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Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2972349A (en) * 1958-12-24 1961-02-21 Univ Minnesota Capillary oxygenator
US3034505A (en) * 1959-02-24 1962-05-15 Bruce J Sobol Fluid circulation system
US3077268A (en) * 1959-05-06 1963-02-12 Univ Pennsylvania Dialyzer
US3198335A (en) * 1965-08-03 Permeation apparatus
US3212498A (en) * 1962-07-11 1965-10-19 Dilectrix Corp Oxygenation-dialysis method
US3228877A (en) * 1960-09-19 1966-01-11 Dow Chemical Co Permeability separatory apparatus and process utilizing hollow fibers
US3232859A (en) * 1961-12-22 1966-02-01 American Mach & Foundry Multi-cell assembly for electrodialysis
US3318795A (en) * 1962-06-06 1967-05-09 American Mach & Foundry Electrodialysis apparatus having gaskets and membranes aligned to reduce leakage
US3357565A (en) * 1965-12-23 1967-12-12 Burger Robert Clinical dialyzer having a flow path decreasing in width
US3457170A (en) * 1966-04-14 1969-07-22 Havens Intern Solvent separation process and apparatus
US3457944A (en) * 1966-03-15 1969-07-29 Sweden Freezer Mfg Co Hemodialysis system
US3482573A (en) * 1967-01-12 1969-12-09 Eastman Kodak Co Artificial kidney system provided with automatic coupling means
US3482574A (en) * 1967-01-12 1969-12-09 Eastman Kodak Co Artificial kidney system provided with a lever actuated shunt coupling mechanism
US3488690A (en) * 1966-10-12 1970-01-06 Nat Res Dev Artificial kidney membrane support means
US3489146A (en) * 1967-01-12 1970-01-13 Eastman Kodak Co Artificial kidney system
US3508662A (en) * 1969-01-21 1970-04-28 Extracorporeal Med Spec Disposable,low-prime,spirally wound,artificial kidney
US3650404A (en) * 1970-02-27 1972-03-21 Antonio A Versaci Disposable dialysis apparatus
FR2345188A1 (fr) * 1975-10-08 1977-10-21 Baxter Travenol Lab Dialyseur

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2341114A (en) * 1943-02-16 1944-02-08 Novak Milan Disposable filter for blood and plasma transfusions
US2650709A (en) * 1948-08-06 1953-09-01 Stephan S Rosenak Continuous extracorporeal dialyzer
US2664395A (en) * 1949-08-24 1953-12-29 Marchand John Felix Dialyzer
US2720879A (en) * 1950-08-01 1955-10-18 Gasca Albin Dialysis apparatus

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2341114A (en) * 1943-02-16 1944-02-08 Novak Milan Disposable filter for blood and plasma transfusions
US2650709A (en) * 1948-08-06 1953-09-01 Stephan S Rosenak Continuous extracorporeal dialyzer
US2664395A (en) * 1949-08-24 1953-12-29 Marchand John Felix Dialyzer
US2720879A (en) * 1950-08-01 1955-10-18 Gasca Albin Dialysis apparatus

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3198335A (en) * 1965-08-03 Permeation apparatus
US2972349A (en) * 1958-12-24 1961-02-21 Univ Minnesota Capillary oxygenator
US3034505A (en) * 1959-02-24 1962-05-15 Bruce J Sobol Fluid circulation system
US3077268A (en) * 1959-05-06 1963-02-12 Univ Pennsylvania Dialyzer
US3228877A (en) * 1960-09-19 1966-01-11 Dow Chemical Co Permeability separatory apparatus and process utilizing hollow fibers
US3232859A (en) * 1961-12-22 1966-02-01 American Mach & Foundry Multi-cell assembly for electrodialysis
US3318795A (en) * 1962-06-06 1967-05-09 American Mach & Foundry Electrodialysis apparatus having gaskets and membranes aligned to reduce leakage
US3212498A (en) * 1962-07-11 1965-10-19 Dilectrix Corp Oxygenation-dialysis method
US3357565A (en) * 1965-12-23 1967-12-12 Burger Robert Clinical dialyzer having a flow path decreasing in width
US3457944A (en) * 1966-03-15 1969-07-29 Sweden Freezer Mfg Co Hemodialysis system
US3457170A (en) * 1966-04-14 1969-07-22 Havens Intern Solvent separation process and apparatus
US3488690A (en) * 1966-10-12 1970-01-06 Nat Res Dev Artificial kidney membrane support means
US3482573A (en) * 1967-01-12 1969-12-09 Eastman Kodak Co Artificial kidney system provided with automatic coupling means
US3482574A (en) * 1967-01-12 1969-12-09 Eastman Kodak Co Artificial kidney system provided with a lever actuated shunt coupling mechanism
US3489146A (en) * 1967-01-12 1970-01-13 Eastman Kodak Co Artificial kidney system
US3508662A (en) * 1969-01-21 1970-04-28 Extracorporeal Med Spec Disposable,low-prime,spirally wound,artificial kidney
US3650404A (en) * 1970-02-27 1972-03-21 Antonio A Versaci Disposable dialysis apparatus
FR2345188A1 (fr) * 1975-10-08 1977-10-21 Baxter Travenol Lab Dialyseur

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Publication number Publication date
CA597994A (en) 1960-05-17
BE558724A (en, 2012)

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