|Publication number||USRE36774 E|
|Application number||US 08/842,528|
|Publication date||11 Jul 2000|
|Filing date||24 Apr 1997|
|Priority date||1 Oct 1989|
|Also published as||US5270004|
|Publication number||08842528, 842528, US RE36774 E, US RE36774E, US-E-RE36774, USRE36774 E, USRE36774E|
|Inventors||Louis C. Cosentino, Jeffrey A. Lee, Daniel A. Baker|
|Original Assignee||Baxter Healthcare Corporation|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (180), Non-Patent Citations (21), Referenced by (12), Classifications (22), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This is a continuation of application Ser. No. 08/263,817, filed on Jun. 22, 1994, now abandoned which is a divisional of application Ser. No. 08/115,996, filed on Sep. 2, 1993, now abandoned, which is a continuation of application Ser. No. 07/844,620, now U.S. Pat. No. 5,270,004 filed on May 11, 1992, .[.which claims priority to PCT/US89/04314 filed Oct. 1, 1990.]. .Iadd.which is a national stage application under 35 U.S.C. 371 of PCT/US89/04314, filed Oct. 1, 1989, .Iaddend.the entireties of which are hereby incorporated by reference.
This invention relates to a blood oxygenator having an integral heat exchanging unit, the oxygenator being of the outside perfusion type.
In known blood oxygenators, hollow fibers are used as a means to bring blood into contact with oxygen and provide a means for removal of carbon dioxide from the blood. The fibers are typically made of a homogeneous membrane of gas-permeable material such as silicone or of hollow fibers made of a microporous membrane of hydrophobic polymeric material such as polyolefins.
There are two types of hollow fiber blood oxygenators: the inside perfusion type in which blood is passed through the bores of the hollow fibers while oxygen is passed on the outside of the hollow fibers, and the outside perfusion type. Blood oxygenators of the outside perfusion type pass oxygen through the bores of the hollow fibers while blood is flowed past the outside of the hollow fibers.
Examples of inside perfusion type hollow-fiber oxygenators are disclosed in U.S. Pat. Nos. 4,239,729 and 4,749,551.
In blood oxygenators of the outside perfusion type the oxygen can be distributed uniformly through the spaces between adjacent fibers and the blood can be expected to move with better mixing. However, outside perfusion has had the disadvantage of being subject to less than the desired oxygenation of the blood because of region channeling of the blood as it passes the outsides of the hollow fibers. Blood-side convective mixing is essential for efficient gas transfer in blood oxygenators. Without such mixing, sharply defined boundary layers of fully oxygenated blood develop near the exchange surfaces and the fluxes of oxygen and carbon dioxide tend to be low. Low transport efficiency results in bulky devices with undesirable high blood priming volumes.
Outside perfusion type blood oxygenators are known in which the hollow fibers are in perpendicular orientation to the direction of blood flow so as to produce more mixing of the blood as the blood flows than inside perfusion constructions. This arrangement can bring about an improvement in oxygenation rate. However, if the number of fibers used in such a blood oxygenator is large (as is desirable) and/or the flow rate of blood is increased in order to treat large volumes of blood, problems arise. For example, unacceptable pressure drop of the blood between inlet and outlets and/or channeling of the blood between groups of fibers may occur. By channeling it is to be understood that a significant flow of blood takes place through relatively large area voids between fibers so that there is little or no mixing. As the rate of oxygen transfer primarily takes place in a thin boundary layer adjacent the hollow fibers, the effectiveness of desired oxygenation is reduced.
Examples of blood oxygenators of the outside perfusion type are disclosed in copending application PCT/US89/00146 filed Jan. 13, 1989; WO 89/00864; and U.S. Pat. Nos. 3,794,468; 4,352,736; 4,622,206; 4,659,549; 4,639,353; 4,620,965; 4,791,054; and 4,808,378, all incorporated herein by reference.
In the prior art it has been recognized that there is considerable heat loss in all extracorporeal circuits and various devices have been introduced for the purpose of maintaining the temperature of blood within the normal physiological range. Devices which combine the function of blood heating and oxygenation are known. U.S. Pat. No. 4,111,659 describes an embossed film membrane heater/oxygenator. U.S. Pat. No. 4,138,288 describes a bubble-type oxygenator with an integral heater at the blood outlet side of the oxygenator. U.S. Pat. No. 4,620,965 describes an outside perfusion type hollow fiber blood oxygenator with an associated heat exchanger, also located on the blood outlet side of the device, in which the blood flows longitudinally through the oxygenator portion of the device and generally parallel to the hollow gas exchange fibers. U.S. Pat. Nos. 4,639,353, 4,659,549 and 4,791,054 also disclose outside perfusion type hollow-fiber oxygenators in which blood flowing longitudinally through a generally rectangular or cylindrical device passes through multiple hollow fiber exchange chambers separated by narrow channel baffles. In some embodiments of the latter device, separate heat and Oxygen exchange chambers are provided.
U.S. Pat. No. 4,645,645 describes a hollow-fiber blood oxygenator to which a helical heat exchanger may be attached. Heat exchange is accomplished by passing blood across the outside of a helical coated metal coil.
U.S. Pat. No. 4,424,910 describes another form of hollow-fiber oxygenator with an attached heater compartment displaced longitudinally on a generally cylindrical device.
A problem with prior blood oxygenator/heater combination devices which has been recognized in the prior art is the considerable bulk, with consequent large priming volume of the combined devices. A flat device is described in WO 89/00864 and co-pending application, PCT/US89/00146 filed Jan. 13, 1989, which locates heated exchange fibers and gas exchange fibers in adjacent compartments separated by a porous wall so as to eliminate collection and distribution manifolds between the devices. Such flat devices, however, are difficult to manufacture because of the difficulty of properly packing the gas exchange fibers for optimal efficiency.
The present invention pertains to a novel compact integrated blood heater/oxygenator in which the blood advantageously flows transversely to the axial direction of hollow heat exchange and oxygenation fibers, the device having a minimal priming volume and which is easily assembled using conventional fiber winding techniques for packing the gas exchange fibers.
The inventive blood heater oxygenator is a generally cylindrical device which is constructed so that the blood enters a central chamber extending longitudinally along the axis of the device and then moves radially through respective annular hollow heat exchange and oxygenation fiber bundles in a direction generally perpendicular to the axis of the device and generally transverse to the axial direction of the fibers toward the outer wall of the device where the temperature adjusted and oxygenated blood is collected and passed out of the device via an exit port.
FIG. 1 is a side perspective view of a blood heat exchanger/oxygenator of the invention.
FIG. 2 is a side plan view with parts cut away of the heat exchanger/oxygenator of FIG. 1.
FIG. 3 shows a sectional view of the heat exchanger/oxygenator of the invention taken along line 3--3 of FIG. 2.
FIG. 4 is a side view of a portion of the device as seen from line 4--4 of FIG. 3.
FIG. 5 is an enlarged perspective view of the portion of FIG. 2 indicated by the bold numeral 5.
The invention is best described by reference to the preferred embodiment as illustrated in FIGS. 1-5.
The preferred heat exchanger/oxygenator device of the invention is generally designated in the figures by the numeral 10. The exterior of device 10 comprises a generally cylindrical exterior wall portion 12, proximal cover member 14 and distal cover member 20. The distal cover 20 includes a central blood inlet port 26, a heating fluid outlet port 28 and a gas outlet port 30.
The proximal cap 14 includes a blood outlet port 32, a heater exchange fluid inlet port 36 and a gas inlet port 38. Raised circular portions 40 and 42 define heat exchange fluid and gas distribution manifolds, respectively, which provide fluid communication between the respective inlet ports 36 and 38 and respective hollow bundles of heat exchange and gas exchange fibers, respectively, within the device. A raised circular portion 44 defines a blood collecting manifold which, as shown in FIG. 1, increases in dimension as it approaches the exit port 32.
On the distal cover 16 there are also included raised circular portions 46 and 48 which define manifolds for collecting and directing heat exchange fluid and oxygenation gas from the fiber bundles to their respective outlet ports.
The interior of the device includes a series of annular cylindrical chambers 50, 54, 58 and 62 separated by tubular porous wall members 52, 56 and 60.
The central chamber 50 communicates with blood inlet port 26. The next outward annular chamber 54 comprises the heat exchanger portion of the device and is filled with heat exchange tubes 70 of known type which extend generally in an axial direction. Annular chamber 58 comprises the oxygenator portion of the device and is filled with tubes 74 of a gas exchange membrane material, also of known type. The gas exchange tubes 74 are also preferably oriented generally in an axial direction. Between the porous wall 60 and the inner surface of the outer wall 12 of the device is a hollow cylindrical blood collection chamber 62.
The tubular porous walls 52, 56, 60, the heat exchange tubes 70, and gas exchange tubes 74 are all potted together with a conventional potting material 76 which holds the various interior components of the device together as a unit and isolates the open ends of the tubes 70 and 74 from the blood flow path.
The respective bundles of heat exchange and gas exchange fibers are desirably simultaneously end potted so as to produce a unitary assembly which can be readily sheared to produce open tube ends as best shown in FIG. 5. The covers 14 and 16 are aligned so that they sealingly engage the potted assembly between the respective fiber bundles. Suitably the porous tubular wall members 52, 56 and 60 are provided with continuous non-porous end portions 80 entrained in the potting material such that when the potted assembly is sheared the end portions 80 expose continuous annular rings which provide sealing surface to engage the covers and isolate the respective gas blood and heating fluid distribution and collection manifolds, as shown in FIGS. 2 and 5. Most preferably the cover assemblies are heat or sonically welded to the end portions 80 and to the ends of outer cylindrical wall 12.
The tubular porous wall members 52, 56 and 60 provide separation between the chambers while allowing blood to pass therethrough without offering substantial resistance or directional change. Any porous structure which allows the passage of blood without significant damage may be used. However, it is preferred that these wall members be constructed of a biocompatible plastic material containing a plurality of spaced orifices 82. The orifices 82 are preferably no greater than 1/2 inch (1.27 cm) and preferably 3/8 inches (0.95 cm) in diameter. Larger diameter orifices will allow the fibers to bulge into the orifices and thereby potentially create void spots in the fiber bundle therebelow. Another disadvantage in fibers bulging into the orifices is that pinching to close a fiber may occur. Smaller diameter orifices may be used, by spacing must be selected so that the total area of the orifices 82 is sufficient to assure that the respective porous tubular wall members do not themselves create significant resistance to blood flow or dead spots where blood may collect and coagulate.
Suitable gas exchange membrane material for fibers 74 may be made of polypropylene, polyethylene or other biocompatible material which provides gas exchange. The fibers are liquid impermeable. Suitable fibers for this purpose are well known and commercially available from a number of manufacturers including Mitsubishi Rayon Sale, Ltd. of Tokyo, Japan and Celanese Chemical Company of New York, N.Y., U.S.A.
The heat exchange tubes 70 are preferably formed from a polyurethane resin such as B. F. Goodrich Estane 58091. The tubes are much larger than the hollow fibers in the oxygenator, typically being about 0.033 inches (840 microns) in outside diameter with a wall thickness of about 0.004 inches (102 microns). In contrast, a typical oxygenator fiber has an outside diameter of about 200-450 microns and a wall thickness of less than 50 microns. The formation of heat exchanger tubes from polyurethane rather than the stainless steel, polyethylene, or polypropylene is preferred. While the efficiency of the heat exchange it an important design consideration, it is vital that there must be no leakage. The end seals where polyurethane potting compounds are used with stainless steel tubes represent potential leakage areas of the cooling fluid into the blood.
The use of polyurethane heat exchange tubes with the polyurethane end potting compounds provides a positive seal which ensures that no leakage will occur. This compatibility with the potting compound greatly increases the safety of the product.
The hollow heat exchange tubes are packed into chamber 70 such that channeling is minimized. However, performance of the heat exchanger is not greatly affected if some channeling is present. A pack density of between about 40% and 60% provides an efficient heat exchanger with an accept&hie pressure drop. It is preferred to pack the polyurethane tubes at about 45%-55% pack density which provides an efficient unit, low pressure drop and low blood priming volume. The thin walled polyurethane hollow tubes provide good heat transfer. The efficiency desired is in ensuring that all of the blood is heated or cooled as desired, not in how much heat exchange fluid is required. The temperature differential between the blood and heat exchange fluid should be low to provide better control.
In the preferred embodiment the overall size of the unit is approximately 5 inches (12.5 cm) in diameter by 7.5 inches (18.75 cm) long. The heat exchange tubes are polymeric tubes having an approximate diameter of 0.033 inches (0.83 mm or 830 μ), and the heat exchange chamber containing approximately 2750 tubes. The gas exchange fibers suitably are microporous hollow polypropylene membrane is sufficient quantity to provide a total blood contact surface area of approximately 3.8 square meters. The device permits an outlet blood oxygen tension of 150 torr or more, tested on bovine blood with a hemoglobin concentration of 12 gram-percent; with an inlet saturation of 55% a blood flow of 6 liters per minute and an oxygen flow of 6 liters per minute. The heat exchanger provides an effectiveness level of 45% as measured by the protocol of the American Association of Medical Instrumentation (AAMI).
The heat exchange tubes are preferably cut to length and then placed into the chamber 52. Winding the tubes about central core 52 is less preferable as it tends to cause the hollow tubes to bend and may cause cracks or breaks.
The gas exchange fiber bundle is most suitably prepared by spiral winding fibers 74 around the tubular wall member 56, successive layers being angled relative to each other to produce a crisscross pattern. The crossing fiber arrangement is preferred over parallel fiber packing since it forces the blood into effective but gentle transverse, mixing without traumatizing the blood. Winding techniques for producing cylindrical bundles of hollow fibers are well known and are described in such references as U.S. Pat. No. 3,755,034, 3,794,468, 4,224,094, 4,336,138, 4,368,124 and 4,430,219, all incorporated herein by reference. The preferred angle between the fibers of successive layers is in the range of between about 10° and 30°, more preferably between about 15° and 20°, most preferably 18°. The fibers run in a generally axial direction, so that an axial plane bisects the angle between the successive layers of the fibers. For instance, in the most preferred embodiment, one layer will deviate from the axial direction by +9° and the next layer will deviate from the axial direction by -9°. The pack density of the gas exchange fibers 74 should be between about 45% and 60%, most preferably about 50% and 55%. When the pack density is too high the resulting resistance to blood flow reduces oxygenation efficiency. Likewise, when the pack density is too low channeling and reduced turbulent flow of the blood also reduces oxygenation efficiency. Within the preferred range oxygenation efficiency is maximized.
For potting the ends of the assembly of fiber bundles and porous wall members 52, 56 and 60, a polyurethane potting compound is preferred. Suitable potting compounds are available from Caschem, Inc. of Bayonne, N.J., U.S.A. A polyurethane casting system of Caschem, Inc. is described in U.S. Pat. Reissue No. 31,389. After potting the hollow fibers are reopened by conventional techniques such as shearing the potting with a sharp knife so as to expose the interiors of the fibers.
After insertion of the potted and sheared assembly into cylinder 12 the cover members 14 and 20 are inserted in line so that they sealingly engage the potted assembly between the respective fiber bundles.
The covers 14 and 20, cylinder case 12 and the porous tubular wall members 52, 56 and 60 are all preferably made from nontoxic biocompatible plastic resins. Suitable resins are polycarbonate resins such as the Lexan brand resins of General Electric Company, Polymer Product Department, Pittsfield, Mass. Lexan 144 grade polycarbonate resins are currently preferred.
In operation, blood entering the device through the central inlet port 26, fills chamber 50 and then passes in a direction generally perpendicular to the axis through porous wall 52, around heat exchange fibers 70, through porous wall 56, around gas exchange fibers 74, through wall 60, into collection chamber 62 and then up into the blood collecting manifold 44 in cover 14, finally exiting the device via blood exit port 32.
An advantage provided by the compact structure of the device is a reduction in priming volume which results because blood is directly passed from the heat exchange chamber 54 to the oxygenation chamber 58 without passing through intermediate collection and distribution manifolds.
Yet another advantage of the invention compared to many of the prior art devices described in the Background section, above, is the location of the heat exchange chamber upstream from the gas exchange chamber. Since gas solubility varies significantly with temperature, it is important that the blood is oxygenated at the temperature it will enter the body. If the blood is heated after it is oxygenated, the oxygenation level may exceed the gas saturation point at the higher temperature, resulting in formation of dangerous emboli. If blood is cooled after oxygenation inefficient oxygenation can result.
Compared to the rectangular devices of WO 89/0864 and PCT/US89/00146, the device of the present invention also provides a significantly less complicated device to manufacture. In particular, to obtain the desired angular and Offset orientation of the gas exchange fibers in the prior art rectangular device it was necessary to employ a manufacturing technique which not only laid alternate layers in a crisscross pattern angled with respect to each other approximately 18', but also required offsetting each successive parallel layer to minimize channeling. In the cylindrical device of the invention the desired crisscrossing of successive layers can readily be performed by conventional spiral winding techniques and the increasing diameter of the winding naturally results in an offset of successive parallel layers without complex controls.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US27100 *||14 Feb 1860||Robert f|
|US32186 *||30 Apr 1861||Improved telegraphic cable|
|US33932 *||17 Dec 1861||Improvement in the base-pin and rammer of revolving pistols|
|US2659368 *||28 May 1949||17 Nov 1953||Jefferson Medical College Of P||Extracorporeal circulation device|
|US2684728 *||17 May 1952||27 Jul 1954||Ind Rayon Corp||Apparatus for removing air from viscose solution|
|US2937644 *||15 Oct 1957||24 May 1960||Corco Inc||Blood oxygenator for facilitating heart surgery|
|US3026871 *||27 Jan 1959||27 Mar 1962||Const Mecaniques De Stains Soc||Apparatus for oxygenating blood|
|US3058464 *||22 Apr 1957||16 Oct 1962||Baxter Laboratories Inc||Oxygenator|
|US3142296 *||31 May 1962||28 Jul 1964||Jack W Love||Blood oxygenator|
|US3171475 *||6 Apr 1962||2 Mar 1965||Baxter Laboratories Inc||Apparatus for blood handling|
|US3211148 *||25 May 1962||12 Oct 1965||Jr John E Galajda||Rotary disk oxygenator and heater|
|US3256883 *||8 Aug 1963||21 Jun 1966||Wall Richard A De||Oxygenator with heat exchanger|
|US3315740 *||14 Jan 1965||25 Apr 1967||Du Pont||Flexible plastic tube bundle and method of making|
|US3342729 *||9 Dec 1964||19 Sep 1967||Dow Chemical Co||Permeability separatory cell and apparatus and method of using the same|
|US3413095 *||14 Jun 1965||26 Nov 1968||Mogens L. Bramson||Membrane oxygenator|
|US3466148 *||15 Feb 1966||9 Sep 1969||Everett Hazen F||Blood oxygenator|
|US3484211 *||8 Dec 1964||16 Dec 1969||Us Army||Membrane oxygenator|
|US3492991 *||23 Feb 1967||3 Feb 1970||Dyer Richard H Jr||Autotransfusion apparatus|
|US3513845 *||15 Sep 1966||26 May 1970||United Aircraft Corp||Bypass heart pump and oxygenator system|
|US3527572 *||11 Oct 1965||8 Sep 1970||Urkiewicz A Edward||Apparatus for treating blood|
|US3547591 *||16 Oct 1968||15 Dec 1970||Torres Jose C||Bubble film oxygenator|
|US3557962 *||28 Jun 1968||26 Jan 1971||North American Rockwell||Reverse osmosis fabric|
|US3651616 *||13 Feb 1969||28 Mar 1972||Rhone Poulenc Sa||Process for effecting absorption or removal of gas from a liquid|
|US3691068 *||8 Jan 1971||12 Sep 1972||Amicon Corp||Dialysis membrane and its use|
|US3722694 *||10 Jun 1970||27 Mar 1973||Romicon Inc||Filtration device|
|US3755034 *||10 Dec 1971||28 Aug 1973||Dow Chemical Co||Method for making a hollow fiber separatory element|
|US3764271 *||10 Jan 1972||9 Oct 1973||R Brumfield||Blood oxygenator in combination with a low pressure heat exchanger|
|US3768653 *||21 Mar 1972||30 Oct 1973||Brumfield R||Filtering cardiotomy reservoir|
|US3769162 *||26 Aug 1971||30 Oct 1973||R Brumfield||Blood oxygenator and thermoregulator apparatus|
|US3769163 *||8 Nov 1971||30 Oct 1973||R Brumfield||Blood oxygenator flow guide|
|US3794468 *||10 Jan 1972||26 Feb 1974||Baxter Laboratories Inc||Mass transfer device having a wound tubular diffusion membrane|
|US3807958 *||5 Jun 1972||30 Apr 1974||Harvey Res Corp William||A bubble oxygenerator including a blood foam return exchanger device|
|US3848660 *||22 Sep 1972||19 Nov 1974||Du Pont||Plastic heat exchange apparatus and a method for making|
|US3853479 *||23 Jun 1972||10 Dec 1974||Sherwood Medical Ind Inc||Blood oxygenating device with heat exchanger|
|US3870470 *||18 Jun 1973||11 Mar 1975||Fumitake Yoshida||Bubble-type blood oxygenator with baffles|
|US3881483 *||12 Sep 1973||6 May 1975||Rhone Poulenc Sa||Extracorporeal blood circuit|
|US3884814 *||23 Jul 1973||20 May 1975||Rhone Poulenc Sa||Apparatus for fractionating fluids|
|US3890969 *||21 Jan 1974||24 Jun 1975||Baxter Laboratories Inc||Cardiopulmonary bypass system|
|US3918912 *||15 Oct 1973||11 Nov 1975||Sherwood Medical Ind Inc||Blood oxygenator|
|US3927981 *||30 Aug 1973||23 Dec 1975||Rhone Poulenc Sa||Membrane-type blood oxygenator with recycle of oxygen-containing gas|
|US3956112 *||13 Mar 1975||11 May 1976||Allied Chemical Corporation||Membrane solvent extraction|
|US3957504 *||11 Nov 1974||18 May 1976||Allied Chemical Corporation||Membrane hydro-metallurgical extraction process|
|US3993816 *||10 Jul 1974||23 Nov 1976||Rhone-Poulenc S.A.||Hollow fiber assembly for use in fluid treatment apparatus|
|US3994689 *||31 Oct 1973||30 Nov 1976||Dewall Richard A||Metabolic bubble oxygenator|
|US4022692 *||1 Aug 1975||10 May 1977||Erika, Inc.||Non-woven support screen for mass transfer devices|
|US4026669 *||14 Jul 1975||31 May 1977||Baxter Laboratories, Inc.||Variable capacity reservoir assembly|
|US4036231 *||20 Nov 1975||19 Jul 1977||Sherwood Medical Industries Inc.||Thoracic drainage unit with defoaming means|
|US4038190 *||29 May 1974||26 Jul 1977||Rhone-Poulenc S.A.||Fluid fractionation apparatus and method of manufacturing the same|
|US4065264 *||10 May 1976||27 Dec 1977||Shiley Laboratories, Inc.||Blood oxygenator with integral heat exchanger for regulating the temperature of blood in an extracorporeal circuit|
|US4077578 *||13 Feb 1976||7 Mar 1978||Baxter Travenol Laboratories, Inc.||Machine for winding hollow filaments|
|US4111659 *||27 Dec 1976||5 Sep 1978||Graeme L. Hammond||Mass and heat transfer exchange apparatus|
|US4140637 *||6 Oct 1977||20 Feb 1979||Walter Carl W||Permeability separatory method and apparatus|
|US4158693 *||29 Dec 1977||19 Jun 1979||Texas Medical Products, Inc.||Blood oxygenator|
|US4168293 *||7 Mar 1977||18 Sep 1979||Bramson Mogens L||Blood oxygenator|
|US4180896 *||16 Oct 1978||1 Jan 1980||Texas Medical Products, Inc.||Blood oxygenator assembly method|
|US4186713 *||25 Oct 1977||5 Feb 1980||Lucas Industries Limited||Ignition systems for internal combustion engine|
|US4187180 *||7 Oct 1977||5 Feb 1980||Nippon Zeon Co. Ltd.||Hollow-fiber permeability apparatus|
|US4188360 *||8 Sep 1978||12 Feb 1980||Japan Medical Supply Co., Ltd.||Artificial lung with a built-in heat exchanger|
|US4202776 *||27 Jan 1978||13 May 1980||Nippon Zeon Co., Ltd.||Hollow-fiber permeability apparatus|
|US4205042 *||23 Jun 1978||27 May 1980||Cobe Laboratories, Inc.||Blood oxygenator with a gas filter|
|US4213858 *||17 Nov 1978||22 Jul 1980||Gambro Ab||Supporting net|
|US4225439 *||13 Oct 1978||30 Sep 1980||Gambro Dialysatoren Gmbh & Co. Kg||Apparatus for selective separation of matter through semi-permeable membranes|
|US4239729 *||1 Jun 1979||16 Dec 1980||Terumo Corporation||Oxygenator|
|US4244094 *||25 Oct 1979||13 Jan 1981||Fabryka Narzedzi Chirurgicznych||Instrument for removing exchangeable blades from surgical scalpes|
|US4254081 *||21 Sep 1979||3 Mar 1981||Research Partners Limited||Blood oxygenator|
|US4256692 *||1 Feb 1979||17 Mar 1981||C. R. Bard, Inc.||Membrane oxygenator|
|US4268279 *||6 Jun 1979||19 May 1981||Mitsubishi Rayon Co., Ltd.||Gas transfer process with hollow fiber membrane|
|US4280981 *||6 Nov 1979||28 Jul 1981||C. R. Bard, Inc.||Blood oxygenator|
|US4282180 *||9 Aug 1977||4 Aug 1981||Bentley Laboratories, Inc.||Blood oxygenator|
|US4306018 *||26 Jun 1980||15 Dec 1981||The Board Of Regents Of The University Of Nebraska||Method of gas-heat exchange|
|US4308230 *||29 May 1979||29 Dec 1981||Bramson Mogens L||Blood oxygenator|
|US4315819 *||12 Jun 1978||16 Feb 1982||Monsanto Company||Hollow fiber permeator apparatus|
|US4346006 *||24 Mar 1980||24 Aug 1982||Baxter Travenol Laboratories, Inc.||Diffusion membrane units with adhered semipermeable capillaries|
|US4352736 *||8 Dec 1980||5 Oct 1982||Toyo Boseki Kabushiki Kaisha||Wound flattened hollow fiber assembly having plural spaced core sections|
|US4372914 *||27 Apr 1981||8 Feb 1983||Bentley Laboratories, Inc.||Blood oxygenator|
|US4374802 *||16 Sep 1981||22 Feb 1983||Terumo Corporation||Oxygenator|
|US4376095 *||14 Aug 1981||8 Mar 1983||Terumo Corporation||Hollow fiber-type artificial lung having enclosed heat exchanger|
|US4389363 *||3 Nov 1980||21 Jun 1983||Baxter Travenol Laboratories, Inc.||Method of potting microporous hollow fiber bundles|
|US4411872 *||16 Dec 1981||25 Oct 1983||Bramson Mogens L||Water unit for use with a membrane blood oxygenator|
|US4414110 *||12 Jan 1981||8 Nov 1983||Cordis Dow Corp.||Sealing for a hollow fiber separatory device|
|US4424190 *||22 Feb 1982||3 Jan 1984||Cordis Dow Corp.||Rigid shell expansible blood reservoir, heater and hollow fiber membrane oxygenator assembly|
|US4425234 *||30 Jul 1979||10 Jan 1984||Hospal Ltd.||Hollow fiber separatory device|
|US4428403 *||4 Jun 1982||31 Jan 1984||Extracorporeal Medical Specialties, Inc.||Conduit having spirally wound monofilament material|
|US4428934 *||29 Jul 1981||31 Jan 1984||Bentley Laboratories, Inc.||Method for oxygenating blood|
|US4440722 *||2 Oct 1981||3 Apr 1984||Dideco S.P.A||Device for oxygenating blood circulating in an extracorporeal circuit with a heat exchanger|
|US4440723 *||10 Jul 1981||3 Apr 1984||Bentley Laboratories, Inc.||Blood oxygenator|
|US4445500 *||30 Sep 1982||1 May 1984||Thomas Jefferson University||Stroke treatment utilizing extravascular circulation of oxygenated synthetic nutrients to treat tissue hypoxic and ischemic disorders|
|US4455230 *||26 Apr 1982||19 Jun 1984||Cobe Laboratories, Inc.||Pleated membrane transfer device utilizing potting and thixotropic adhesive|
|US4466804 *||24 Sep 1981||21 Aug 1984||Tsunekazu Hino||Extracorporeal circulation of blood|
|US4493692 *||29 Sep 1982||15 Jan 1985||Reed Charles C||Blood gas concentration control apparatus and method|
|US4533516 *||6 Jul 1982||6 Aug 1985||Gambro Cardio Ab||Apparatus for the transfer of one or more substances between a gas and a liquid|
|US4540492 *||20 Dec 1982||10 Sep 1985||Millipore Corporation||Method and apparatus for treating whole blood|
|US4556489 *||9 Mar 1983||3 Dec 1985||Shiley Incorporated||Membrane oxygenator|
|US4559999 *||8 Apr 1983||24 Dec 1985||Shiley, Inc.||Heat exchanger for extracorporeal circuit|
|US4588026 *||22 Oct 1981||13 May 1986||Raytheon Company||Coiled heat exchanger|
|US4599093 *||2 Aug 1984||8 Jul 1986||Steg Jr Robert F||Extracorporeal blood processing system|
|US4612170 *||13 Jun 1983||16 Sep 1986||Luther Ronald B||Blood oxygenator with dual sparger and reuseable heat exchanger|
|US4622140 *||30 Oct 1980||11 Nov 1986||Extracorporeal Medical Specialties, Inc.||Device useful in the treatment of blood|
|US4622206 *||21 Nov 1983||11 Nov 1986||University Of Pittsburgh||Membrane oxygenator and method and apparatus for making the same|
|US4637917||14 Oct 1983||20 Jan 1987||Reed Charles C||Bubble oxygenator|
|US4639353||23 Apr 1985||27 Jan 1987||Mitsubishi Rayon Co., Ltd.||Blood oxygenator using a hollow-fiber membrane|
|US4645645||4 Apr 1985||24 Feb 1987||Renal Systems, Inc.||Oxygenator having an improved heat exchanger|
|US4650457||16 Aug 1985||17 Mar 1987||Kuraray Co., Ltd.||Apparatus for extracorporeal lung assist|
|US4656004||17 May 1985||7 Apr 1987||Cobe Laboratories, Inc.||Medical heat exchange|
|US4657743||8 Jul 1985||14 Apr 1987||Terumo Corporation||Heat exchanger-incorporated hollow fiber type artifical lung|
|US4658367||23 Aug 1984||14 Apr 1987||Hewlett-Packard Company||Noise corrected pole and zero analyzer|
|US4659549||18 Dec 1984||21 Apr 1987||Mitsubishi Rayon Co., Ltd.||Blood oxygenator using a hollow fiber membrane|
|US4684508||5 May 1986||4 Aug 1987||American Hospital Supply Corp.||Blood heat exchanger|
|US4686085||23 Feb 1984||11 Aug 1987||Thomas Jefferson University||Stroke treatment utilizing extravascular circulation of oxygenated synthetic nutrients to treat tissue hypoxic and ischemic disorders|
|US4704203||9 Jun 1986||3 Nov 1987||Reed Charles C||Cardiotomy reservoir apparatus and method|
|US4705508||30 Sep 1985||10 Nov 1987||Regents Of The University Of Minnesota||Apparatus and method for rapid infusion of circulatory supportive fluids|
|US4707587||27 Jan 1986||17 Nov 1987||Greenblatt Gordon M||Blood warming method and apparatus using gaseous heat exchange medium|
|US4717377||15 Aug 1986||5 Jan 1988||Terumo Kabushiki Kaisha||Blood circulating circuit for membrane-type artificial lung, and reservoir for use in blood circulating circuit|
|US4722829||24 Mar 1986||2 Feb 1988||Giter Gregory D||Blood oxygenator|
|US4734269||11 Jun 1985||29 Mar 1988||American Hospital Supply Corporation||Venous reservoir bag with integral high-efficiency bubble removal system|
|US4735775||17 Sep 1986||5 Apr 1988||Baxter Travenol Laboratories, Inc.||Mass transfer device having a heat-exchanger|
|US4756705||8 Dec 1986||12 Jul 1988||Gambro, Ab||Heart-lung system using the lung as an oxygenator|
|US4769959||8 Jul 1983||13 Sep 1988||Lindsey Manufacturing Company||Temporary power line tower assembly and method of installing same|
|US4772256||7 Nov 1986||20 Sep 1988||Lantech, Inc.||Methods and apparatus for autotransfusion of blood|
|US4775360||9 Jan 1987||4 Oct 1988||Lantech, Inc.||Autologus blood methods and apparatus|
|US4781889||3 Aug 1987||1 Nov 1988||Terumo Kabushiki Kaisha||Hollow fiber membrane type artificial lung|
|US4791054||8 Dec 1986||13 Dec 1988||Mitsubishi Rayon Co., Ltd.||Heat exchanger and blood oxygenating device furnished therewith|
|US4828543||3 Apr 1986||9 May 1989||Weiss Paul I||Extracorporeal circulation apparatus|
|US4857081||17 May 1988||15 Aug 1989||Separation Dynamics, Inc.||Separation of water from hydrocarbons and halogenated hydrocarbons|
|US4863600||22 Dec 1986||5 Sep 1989||Baxter International Inc.||Hollow fiber bundle having transverse binding means and method of making same|
|US4869822||29 Aug 1988||26 Sep 1989||Ube Industries, Ltd.||Filter apparatus employing hollow fibers|
|US4874581||7 Jul 1988||17 Oct 1989||Baxter International Inc.||O2 /CO2 control in blood oxygenators|
|US4876066||14 Jul 1987||24 Oct 1989||Baxter International Inc.||Integrated membrane oxygenator, heat exchanger and reservoir|
|US4909989||27 Mar 1989||20 Mar 1990||Terumo Kabushiki Kaisha (Terumo Corporation)||Gas-exchange membrane for an artificial lung|
|US4911846||22 May 1989||27 Mar 1990||Kuraray Co., Ltd.||Fluid treating apparatus and method of using it|
|US4923679||25 Jul 1989||8 May 1990||Terumo Kabushiki Kaisha||Hollow fiber membrane type oxygenator and method for manufacturing same|
|US4948560||12 May 1989||14 Aug 1990||Terumo Corporation||Oxygenator|
|US4950391||15 Feb 1989||21 Aug 1990||Secon Gmbh||Capillary dialyzer|
|US4954317||23 Aug 1989||4 Sep 1990||Baxter International, Inc.||Blood oxygenator|
|US4971836||11 Dec 1989||20 Nov 1990||Terumo Kabushiki Kaisha||Method for manufacture of hollow fiber membrane type artificial lung|
|US4976682||16 Nov 1988||11 Dec 1990||Lane Perry L||Methods and apparatus for autologous blood recovery|
|US5011469||29 Aug 1988||30 Apr 1991||Shiley, Inc.||Peripheral cardiopulmonary bypass and coronary reperfusion system|
|US5026525||19 May 1988||25 Jun 1991||Terumo Kabushiki Kaisha||Extracorporeal blood circulating apparatus|
|US5034188||9 Feb 1988||23 Jul 1991||Senko Medical Instrument Mfg. Co., Ltd.||Artificial lung|
|US5037610||23 Feb 1990||6 Aug 1991||Terumo Kabushiki Kaisha||Method for manufacturing a hollow fiber membrane oxygenator|
|US5039482||9 Dec 1988||13 Aug 1991||Shiley Inc.||Integrated unit for extracorporeal blood circuits|
|US5039486||12 Apr 1989||13 Aug 1991||Baxter Inrternational, Inc.||Liquid and gas separation system|
|US5049146||31 May 1989||17 Sep 1991||Baxter International, Inc.||Blood/gas separator and flow system|
|US5058661||21 Jun 1988||22 Oct 1991||Terumo Kabushiki Kaisha||Heat exchanger with leakage collector|
|US5084244||12 Jun 1991||28 Jan 1992||Terumo Kabushiki Kaisha||Artificial lung assembly|
|US5102533||7 Aug 1991||7 Apr 1992||Terumo Kabushiki Kaisha||Material exchangers|
|US5106579||27 Sep 1990||21 Apr 1992||Terumo Corporation||Membrane type artificial lung and method for manufacture thereof|
|US5110548||10 Mar 1988||5 May 1992||Montevecchi Franco M||Apparatus for concurrently oxgenating and pumping blood circulated extra-corporeally in cardiovascular systems|
|US5110549||28 Feb 1991||5 May 1992||Baxter International Inc.||Liquid and gas separation system|
|US5112480||6 Jul 1988||12 May 1992||Terumo Kabushiki Kaisha||Blood reservoir|
|US5116308||10 Jan 1990||26 May 1992||Terumo Kabushiki Kaisha||Apparatus for processing fluid and method of driving the same|
|US5117903||12 Jul 1988||2 Jun 1992||Terumo Kabushiki Kaisha||Multitube heat exchanger with uniform-flow baffles in head chamber|
|US5120302||6 Jul 1990||9 Jun 1992||Dideco, S.P.A.||Blood container for medical apparatus|
|US5120501||20 Oct 1988||9 Jun 1992||Baxter International Inc.||Integrated membrane blood oxygenator/heat exchanger|
|US5120502||21 Nov 1990||9 Jun 1992||Baxter International Inc.||Pressure relief valve for membrane oxygenator|
|US5124127||26 Jan 1989||23 Jun 1992||Shiley, Incorporated||Hollow fiber blood oxygenator|
|US5151192||13 Jul 1990||29 Sep 1992||Pall Corporation||Method for removing heparin from blood or plasma|
|US5158533||26 Mar 1991||27 Oct 1992||Gish Biomedical, Inc.||Combined cardiotomy/venous/pleural drainage autotransfusion unit with filter and integral manometer and water seal|
|US5160615||18 Apr 1991||3 Nov 1992||Terumo Kabushiki Kaisha||Hollow fiber type liquid processing apparatus|
|US5162102||16 Sep 1988||10 Nov 1992||Terumo Kabushiki Kaisha||Medical instrument and production thereof|
|US5167921||19 Nov 1991||1 Dec 1992||Baxter International Inc.||Liquid and gas separation system|
|US5225161||10 Mar 1992||6 Jul 1993||Baxter International Inc.||Integrated membrane blood oxygenator/heat exchanger|
|US5234663||18 Mar 1992||10 Aug 1993||Shiley, Inc.||Hollow fiber blood oxygenator|
|US5236665||4 Nov 1992||17 Aug 1993||Baxter International Inc.||Hollow fiber treatment apparatus and membrane oxygenator|
|US5266265||8 Oct 1992||30 Nov 1993||Baxter International, Inc.||Modular disposable blood oxygenator/heat exchanger with durable heat source component, selectively including rotary or ventricular blood pump, venous reservoir, and auxiliary heat exchange component|
|US5316724||15 Sep 1992||31 May 1994||Baxter International Inc.||Multiple blood path membrane oxygenator|
|US5322500||4 Mar 1993||21 Jun 1994||Cardio Pulmonary Supplies, Inc.||Variable ratio blood-additive solution device and delivery system|
|US5338512||2 Mar 1993||16 Aug 1994||Baxter International Inc.||Method for oxygenation of a patient's blood|
|US5358689||15 Apr 1993||25 Oct 1994||Shiley Incorporated||Hollow fiber blood oxygenator|
|US5411706||9 Feb 1994||2 May 1995||Hubbard; Lloyd C.||Pump/oxygenator with blood recirculation|
|US5489382||27 Jul 1992||6 Feb 1996||Terumo Kabushiki Kaisha||Oxygenator using porous hollow fiber membrane|
|US5489413||16 Jun 1994||6 Feb 1996||Cobe Laboratories, Inc.||Hollow fiber blood oxygenator|
|USRE27100||20 Jun 1968||30 Mar 1971||Oxygenator with heat exchanger|
|USRE32186||23 Dec 1982||17 Jun 1986||American Hospital Supply Corp.||Fluid transfer apparatus and method of fluid transfer|
|USRE33932||20 Feb 1990||19 May 1992||Terumo Corporation||Hollow fiber-type artificial lung|
|DE2456932A1||2 Dec 1974||10 Jun 1976||Gebhard Roggors||Magnetic field oxygenation enclosure - for gas exchange between blood and a gas atmosphere in a magnetic field|
|EP0114732A2||13 Jan 1984||1 Aug 1984||Baxter Travenol Laboratories, Inc.||Blood oxygenator|
|EP0217759B1||24 Sep 1986||14 Jun 1989||SORIN BIOMEDICA S.p.A.||Improvements in hollow-fibre oxygenators for blood|
|SU543400A1||Title not available|
|SU554869A1||Title not available|
|1||Belter et al, "Bioseparations: Downstream Processing for Biotechnology", A Wiley-Interscience Publication, Chapter 9 (Ultrafiltration and Electrophoresis), (1986), pp. 237-270.|
|2||*||Belter et al, Bioseparations: Downstream Processing for Biotechnology , A Wiley Interscience Publication, Chapter 9 (Ultrafiltration and Electrophoresis), (1986), pp. 237 270.|
|3||*||Bird et al, Transport Phenomena, Wiley, 1980, Sections 2.3,6.2, 6.4.|
|4||*||Cussler, A Mass Transfer Tutorial, Chemtech, (Jul., 1986), pp. 422 425.|
|5||Cussler, A Mass Transfer Tutorial, Chemtech, (Jul., 1986), pp. 422-425.|
|6||*||Cussler, Diffusion: Mass transfer in fluid systems, Cambridge University Press, 1984, Chapter 2,, pp. 15 54 and Chapter 9, pp. 215 248.|
|7||Cussler, Diffusion: Mass transfer in fluid systems, Cambridge University Press, 1984, Chapter 2,, pp. 15-54 and Chapter 9, pp. 215-248.|
|8||*||Semmens et al, Ammonia Removal From Water Using Microporous Hollow Fibers, undated paper, pp. 1 21.|
|9||Semmens et al, Ammonia Removal From Water Using Microporous Hollow Fibers, undated paper, pp. 1-21.|
|10||*||Treybal, Mass Transfer Operations, Third Edition, McGraw Hill Book Company, (1980), pp. 47 54, 74 75.|
|11||Treybal, Mass-Transfer Operations, Third Edition, McGraw-Hill Book Company, (1980), pp. 47-54, 74-75.|
|12||Wickramasinghe et al, "Mass transfer in various hollow fiber geometrics", Journal of Membrane Science, 69 (1992) pp. 235-250.|
|13||*||Wickramasinghe et al, Mass transfer in various hollow fiber geometrics , Journal of Membrane Science, 69 (1992) pp. 235 250.|
|14||Wickramasingle, et al, "Hollow Fiber Modules Made With Hollow Fiber Fabric", Undated Paper, pp. 1-21.|
|15||*||Wickramasingle, et al, Hollow Fiber Modules Made With Hollow Fiber Fabric , Undated Paper, pp. 1 21.|
|16||*||Winston, et al, Membrane Handbook, Prasad et al, Membrane Based Solvent Extraction, (1992) Chapter 41, pp. 727 763.|
|17||Winston, et al, Membrane Handbook, Prasad et al, Membrane-Based Solvent Extraction, (1992) Chapter 41, pp. 727-763.|
|18||Yang et al, "Artifical Gills", Journal of Membrane Science, 42 (1989) pp. 273-284.|
|19||*||Yang et al, Artifical Gills , Journal of Membrane Science, 42 (1989) pp. 273 284.|
|20||*||Yang et al, Designing Hollow Fiber Contactors, AlChE. Journal, (Nov. 1986), vol. 32, No. 11, pp. 1910 1916.|
|21||Yang et al, Designing Hollow-Fiber Contactors, AlChE. Journal, (Nov. 1986), vol. 32, No. 11, pp. 1910-1916.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US6402967 *||29 Apr 1998||11 Jun 2002||Eclipse Environmental Australia Pty Limited||Grease separating device and method|
|US6682698||23 Aug 2001||27 Jan 2004||Michigan Critical Care Consultants, Inc.||Apparatus for exchanging gases in a liquid|
|US8388566||5 Mar 2013||Sorin Group Italia, S.r.l.||Oxygenator with integrated arterial filter including filter frame|
|US8394049||12 Mar 2013||Sorin Group Italia S.R.L.||Blood processing unit with modified flow path|
|US8545754||23 Apr 2009||1 Oct 2013||Medtronic, Inc.||Radial design oxygenator with heat exchanger|
|US8652406||30 Jan 2013||18 Feb 2014||Sorin Group Italia S.R.L.||Blood processing unit with modified flow path|
|US8795220||16 Nov 2010||5 Aug 2014||Politecnico Di Milano||Blood processing unit with circumferential blood flow|
|US8980176||18 May 2011||17 Mar 2015||Sorin Group Italia S.R.L.||Blood processing unit with cross blood flow|
|US9162022||25 Jan 2013||20 Oct 2015||Politecnico Di Milano||Oxygenator with integrated arterial filter including filter frame|
|US20120018367 *||30 Mar 2010||26 Jan 2012||Kubota Corporation||Membrane separator|
|EP2524712A1 *||17 May 2011||21 Nov 2012||Sorin Group Italia S.r.l.||Blood processing unit with cross blood flow|
|WO2012156907A1 *||15 May 2012||22 Nov 2012||Sorin Group Italia S.R.L.||Blood processing unit with cross blood flow|
|U.S. Classification||422/46, 261/DIG.28, 426/48, 210/321.88, 210/321.79, 210/321.64|
|International Classification||B01D63/04, A61M1/16, B01D63/02|
|Cooperative Classification||Y10S128/03, Y10S261/28, B01D2313/38, B01D63/025, A61M1/1698, B01D63/02, A61M2206/16, B01D63/04, A61M1/1625, A61M1/1629|
|European Classification||B01D63/02, B01D63/04, A61M1/16S|
|10 Jun 1999||AS||Assignment|
Owner name: BAXTER HEALTHCARE CORPORATION, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MINNTECH CORPORATION;REEL/FRAME:010018/0314
Effective date: 19981123
|19 Jun 2001||AS||Assignment|
Owner name: EDWARDS LIFESCIENCES CORPORATION, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BAXTER HEALTHCARE CORPORATION;REEL/FRAME:011979/0094
Effective date: 20010607
|26 May 2004||FPAY||Fee payment|
Year of fee payment: 8
|27 May 2008||FPAY||Fee payment|
Year of fee payment: 12
|2 Jun 2008||REMI||Maintenance fee reminder mailed|