United States Patent 1191. [11] Rosenberg [45] Oct. 16, 1973 [54] DUAL BLOOD FILTER 2,914,181 . , 333,32 N.Y. 3,701,433 [751 111mm Dav-d J- Rosenberg, Glen Cove, , 11/1959 3,765,537 Naftulus et a1. .................. .. 210/446 .................... .. 0 44 if}??? 322?; .......... .. 15812132‘: 10/1972 Krakauer",................... .. 210/446 X [73] Assignee: Pall Corporation, Glen Cove, NY. . . Primary Examiner—-Samih N. Zaharna [22] Flled' July 31’ 1972 [21] Appl. No.: 276,623 Assistant Examiner-Richard W. Burks Attorney-John R. Janes Related US. Application Data [63] Continuation-impart of Ser. No. 38,356, Nov. 10, 1970, P t. N . 3, l, 3, ' ' [57] -' - of Ser_ 130 223,532, 33w ilgfilaggmmuanon m part ABSTRACT . . , . A disposable ?lter element is provlded, capable of passmg human blood at _a high flow rate and useful 1n human blood transfusion systems, to remove unde éil """"""""" " 210/446’ zlo/étisdlzdlgggg sired suspended particles, substantially without re. [58] Field of Search .................. .. 128/214 B, 214 c; m°val.‘?f “91ml mid ‘les‘rable bl°°d c°mp°nems’ 2lO/446 493 499 505 507 compnsmg 1n comb1nat1on two ?lter elements, the ' [561 " ’ ’ ’ ?rst comprising plastic netting and having a pore size References Cited UNITED STATES PATENTS $31? 3331121323 2311252253,?!’ $331,021,351; mesh having a pore size within the range from about 1 2,473,153 2,571,059 5/1949 10/1951 Lager ............................ .. 128/214 C‘ Puschelberg et a1 .......... .. 210/507 X 2,644,586 7/1952 Cutter ....................... .. 128/214 C X 25 20 to about 50 microns, 32 Claims, 6 Drawing Figures / it 8 E“ I‘ 27 12 , ' ‘ . 22 a 24 23. _ 20 SEE FIG. 3 36 15 '1 _ gm ‘i ' __ ,. / ,3 3 21 25 3,765,537 _ 1 DUAL BLOOD FILTER This application is a continuation-in-part of Ser. No. 88,356, ?led Nov. 10, 1970, now U.S. Pat. No. 3701433 granted Nov. 21, 1972, and Serial No. 263,584, ?led June 16, 1972. There are in general two types of blood ?lter avail able on the market for use in human blood transfusions. The most common type is made of wire mesh, or nylon 2 oxygenator was ?ltered, a pressure gradient was built up across the ?lter, necessitating a switch to another ?lter hooked up in parallel to the ?rst; and also air was trapped in the ?lter during initial ?lling, and was found to be possibly ejected later, directly into the arterial line. The blood reached a very low level of blood plate lets within the ?rst 10 minutes of use of the ?lter, and this condition persisted during the entire period of by pass. There was also a drop in white blood cells, and the or polyester ?lament mesh, having a pore size within 10 decrease in both was much more pronounced than usu the range from about 125 to about 140 microns (Surgi ally seen in heart-lung bypass, showing that the ?lter cal Advances, V0. 11, No. 6, September, 1951). These caught huge amounts of platelets and, to a lesser ex ?lters are referred to as blood strainers. They are very tent, white cells. The pressure gradient built up across coarse in pore size, because they have a strong ten the ?lter was in part attribued to this mass of cells, and dency to block quickly if the pore size is any finer. in part to intravascular coagulation with formation of The other type of blood ?lter useful in transfusions is a rather thick nonwoven ?brous mat, usually of poly caught on the ?lter tended to disintegrate subse ester ?bers, and referred to as a Dacron wool ?lter. quently, and the disintegration products entered the fil ?brin trapped in the ?lter. Moreover, the platelets This ?lter is the subject of U.S. Pat. No. 3,448,041 tp tered blood. R. L. Swank, issued June 3, 1969, The ?lters available 20 The invention of Ser. No. 88,356, ?led Nov. 10, commercially have a pore size up to several hundred 1970, provides a disposable ?lter element comprising microns, and are prepared of very ?ne ?bers. The principle upon which the Swank ?lter is based is described in the patent at column 3, starting at line 51 a woven square-weave plastic mesh of polyester mono ?laments having a pore size within the range from about 25 to about 50 microns, the ?laments being and continuing through column 4, line 36. Swank 25 locked in place at their crossing points, and the fila wanted a ?nely subdivided material having surface ments having a diameter within the range from about 25 to about 50 microns. Such ?lter elements are capa~ characteristics and a size such that it selectively col lects the storage-altered components of blood used in ble of removing microemboli from human blood in blood transfusions. The filter is intended to act as a human blood circulation systems that require circula base to which the adhesive storage-altered platelets and 30 tion of the blood at a high ?ow rate without removal of leucocytes adhere. Free passage of the other blood normal and desirable blood components. The ?lter re components is supposed to be permitted by the ?lter, moves not only microemboli but also lipids and debris which has a large area of absorbing surface, to achieve and gas emboli, and it also has a low resistance at high a high capacity with a minimum apparatus size. Swank ?ow rates and at a high flow‘ capacity, and does not also wanted a material which could be used over long 35 tend to block over long periods of use. operating periods without collapse or plugging, and without being affected adversely by repeated subjec However, for use in blood transfusion, this ?lter is not fully satisfactory. Blood for use in transfusions has tion to heat and chemical sterilization. The problem of blood strainers is that they do not re a tendency to contain blood clots, a condition not nor mally encountered in human blood circulation systems, move enough of the small ?nely-divided material, be 40 which utilize the blood of the patient in the circulation cause of their large pore size. On the other hand, the system. Blood clots are sticky masses of material, and nonwoven ?brous mat ?lters are at the other extreme. if large numbers of blood clots are present, the woven square weave plastic mesh can block very quickly. these ?lters remove too much material, and also have In accordance with the invention, a dual blood ?lter a very high tendency to block. Large numbers of plate 45 element is provided which can be used in blood transfu lets and white blood cells and bodies of like size in the sions without blockage, and which is capable of remov Despite their large pore size, in excess of 100 microns, blood tend to be strained out, leading to rapid blocking, ing not only large particles, such as blood clots, but also and a compression of the mat under the increased fluid smaller particles, down to approximately 2044. in size, pressure differential thereacross. Both of these effects while passing red blood cells and at least a substantial 50 are undesirable. These results are reported by Egeblad, proportion of white blood cells. The blood ?lter cas Osborn, Burns, Hill and Gerbode, The Journal of Tho cade of the invention comprises two ?lter sheets, ar racic and Cardiovascular Surgery, Vol. 63, No. 3, ranged in downstream ?ow sequence in order of pro March, 1972, pp. 384-390; and by McNamara, Burran gressively increasing ?neness, i.e. from coarsest to ?n and Suehiro in a paper entitled “Effective Filtration of est in pore size. ‘ Banked Blood,” (a copy of this paper is in the ?le of 55 The ?rst ?lter sheet is coarse open netting of plastic U.S. application Ser. No. 88,356, ?led Nov. 10, 1970). Egeblad et al. report that they had good results using the Dacron wool ?lter during perfusion for open-heart ?lamentary material having a pore size within the range from about 800 to about 4,000 microns. This pore size is ‘small enough to remove blood clots which range surgery, where the ?lter was placed in the line between from 500 to 1,000 microns in diameter, and it is coarse 60 the cardiotomy reservoir an the main venous line, in enough to do so without being subject to blocking by which position a large proportion of the circulating the blood clots that are strained out. blood system bypasses the ?lter. Such a system requires The second ?lter sheet is an open- or square-weave a much higher rate of flow of blood per unit of time mesh fabric of plastic mono?laments, having a pore than a blood transfusion system, so that the results ob size within the range from about 20 to about 50 mi tained represent results similar to those obtained in crons. This ?lter sheet removes microemboli, lipids and blood transfusion, but in a shorter time. When placed debris, and gas emboli, virtually all of the particles that in the arterial line, so that all blood coming from the pass through the ?rst ?lter element except platelets, 3,765,537 3 4 white blood cells, red blood cells, and other like ?ne particles. 7 The ehtylene glycol-terephthalic acid polyester ' mono?laments are preferred because of their availabil This combination of ?lter sheets can be referred to as a cascade, because each succeeding ?lter sheet in the line of flow removes some of the particles passed by the next-preceding ?lter sheet. The relative proportion ity and low cost. However, polyesters of other glycols and acids can be used. Exemplary polyester mono?lament screen cloths which can be employed as ?lter sheets in accordance of particles removed by the individual ?lter sheets of with the invention are made from polyester mono?la this ?lter cascade is remarkably distributed between ment 20, 25 and 40 microns in diameter with (a) a mesh opening of 53 microns with 33 percent open area, (b) a mesh opening of 44 microns with 27 percent open area, (0) a mesh opening of 37 microns with 23 percent open area, and (d) a mesh opening of 21 microns with both filter sheets, so that neither ?lter sheet has a ten decny to block over a given blood transfusion to a sin gle patient. For sanitary reasons, blood transfusion ?l ters are not reused, even for the same patient, if a sec ond transfusion is administered at a later time; and since the ?lter element cascades of the invention are fully disposable, their use resolves the blocking prob 14.5 percent open area. Similar screen cloths are avail 15 able, made of polyamide ?laments, polyvinylidene chloride ?laments, and polypropylene ?laments. lem common to blood ?lters which are ?ne enough to remove small particles such as the adhesive nonviable It is also preferred that the mono?laments of the woven square-weave mesh be locked in position at The ?rst ?lter sheet has an open-mesh netting struc their points of crossing. The locking not only increases strength and rigidity, but it also ?xes the pores against change in dimensions in use, which is extremely impor platelets. ture. It is prepared by extruding, casting, or molding 20 plastic into an open-netting having an integral ?lamen tary structure. The plastic material used is compatible with blood. Exemplary are polypropylene, polyethylene, polyester, polyamide, and polycarbonate. One form corresponds to an open square-weave woven ?lamentary netting, even though it is not manu factured by weaving techniques from ?lamentary mate rial. An extruded open-mesh plastic ?lamentary poly propylene sheet is available commercially under the trademark “Vexar.” ' tant. The dual ?lter sheet cascade of the invention can be ?tted into disposable ?lter elements of any design and con?guration. For maximum open area and high flow 25 rate in a con?ned space the two ?lter sheets are prefer ably assembled in close juxtaposition, although they can also be separated by spacers, and both are prefera bly corrugated or convoluted, to provide a high surface area to flow, together with any spacers present. The spacer or support material is stiffer than the ?lter sheets, and is preferably ?exible, and also preferably of Other forms of netting are available which do not plastic, so that it can be bonded to the same end cap in correspond to an open square-weave fabric. In these, a ?lter element or to the ?lter bag. The spacer has a the ?lamentary plastic material can be arranged in a pore size at least as large as the ?rst ?lter sheet, and manner to de?ne round, elliptical, or polygonal open 35 preferably larger, within the range from about 800 to ings, which can, for example, be triangular, square, rectangular, pentagonal, hexagonal, heptagonal, and octagonal, singly or in pattern combinations. One de about 10,000 microns. I As the spacer, any sheet having an uneven surface, such as dimpled, ridged, or quilted, and with large openings therethrough, can be used. Extruded, cast and plastic ?lamentary material and arranged in groups of 40 molded netting are useful, as also are perforated sheets, sign, for example, has triangular openings separated by six to form a hexagonal pattern, and another has trian of polypropylene, polyethylene, polyester, polycarbon gular openings arranged in groups of two to form a dia ate, and polyamide. The surface of the spacer or sup mond. The shape of the open pores in the netting is in port is suf?ciently uneven so as to provide drainage and no way critical, but it is important that the pore size be prevent blocking of the medium and ?ne ?ler sheets by within the range from about‘ 800 to about 4,000 mi 45 the support sheet. A preferred supporting material is crons, the pore being measured across the largest and Vexar mesh (extruded polypropylene netting). the smallest dimensions, if it is other than round or The spacers can also assist in retaining the ?lter sheet symmetrical such as square. cascade in a desired shape, such as particularly a corru The second ?lter sheet is a woven open-mesh square gated shape. The spacer if present is usually in close weave fabric which can be made of any plastic mono?l juxtaposition to or in contact with the second ?lter ament compatible with blood, such as polypropylene, sheet of the cascade. No spacer sheet need precede or polyethylene, polyester, polyamide, and polycarbon follow the ?rst ?lter sheet of open netting, bcause of its ate, and has a pore size within the range from about 20 large pore size. I to about 50 microns. The mono?laments have a diame A suitable con?guration of ?lter element has the ?l ter within the range from about 20 to about 50 microns. ter sheets folded into a corrugated cylinder, the open Polyester mono?laments are preferred. Most polyes~ ends of which are closed off by end caps, limiting ac ter mono?laments available are polyesters of ethylene cess to the ?ltrate ?ow line to flow through the ?lter glycol and terephthalic acid available under the trade mark “Dacron.” Polyester mono?laments can also be cascade, the ?ltrate ?ow line being in operative con~ nection to at least one of the end caps. The end caps made of other polymers of alkylene glycols and dicar 60 are preferably of plastic material and can, for example, boxylic acids, usually aromatic acids, but also cycloali phatic and aliphatic acids, of which propylene glycol l,2, butylene glycol-2,3 and -l ,2, and pentylene glycol l,2 and -2,3 and -l ,3 are exemplary, esteri?ed with ter be of polyester or polypropylene or polycarbonate. The end caps can be bonded to the corrugated ?lter sheet cascade using a potting compound or an adhesive of conventional type. However, to ensure a leak-tight seal, ephthalic acid or alkyl-substituted terephthalic acids, 65 it is preferred to fuse the end caps to the ?lter sheet or adipic or subaric acids, or cyclohexane-l,4— dicarboxylic acid. cascade, and for this purpose a polyole?n, such as poly ethylene or polypropylene, is preferred as the end cap 5 3,765,537 material. Othe plastic materials that can be used as the end caps include polyamides, polycarbonates, and polyester, as well as Te?on polytetra?uoroethylene and Kel-ef polytrifuorochloroethylene, but these are more dif?cult to bond. Another suitable form of ?lter element has the ?lter sheet cascade and spacer sheets in corrugated form en cased in a plastic bag across the line of ?ow between the inlet and the outlet of the bag, which can, for exam ple, be in the form of line connections such as tubes opening onto opposite sides of the ?lter sheet cascade. This type is especially useful for attachment to blood transfusion bags, and can be provided with a piercing tube connection for this purpose, if desired. The cascade ?lter element of the invention can be 15 used in ?lter units intended for simple blood transfu 6 each side a pair of locating ?ngers 15, and portion 3 has on each side two pairs of locating ?ngers 16, with a slot 17 therebetween into which ?ngers 15 ?t. These locate the portions 2, 3 on assembly. Sides 12, 13 at their ends abut sides 9, 10, and are fused thereto, so that the hous ing portions are bonded together as one piece. A pair of projecting members 20, 21 on portion 3 extend par allel to and internally of sides 12, 13 all the way to the internal wall of housing portion 2. The two-component ?lter sheet cascade and spacer composite 40 at each edge 22, 23 projects into the sockets 24, 25 de?ned by sides 12, 13 and members 20, 21, and where the three sheet-composite curves around the tips of members 20, 21, it is held tightly at 26, 27 against the internal wall of portion 2 and is bonded thereto. The bond is produced by fused integration of the member 20, 21 to the housing portion 2 through the desired. The cascade ?lter element can accordingly be open pores of the two-?lter sheets 41, 42 and the provided with ?ttings or line connections suitable to 20 spacer 44 forming a ?uid-tight seal at 26, 27 all along adapt it for in-line connection in blood transfusion sys those sides of the composite, and bonding all three sion where high ?ow rates are not encountered, as in drip or gravity ?ow from blood bags, pump-assisted, if tems of any type. Preferred embodiments of the invention are illus tained, for example, by ultrasonic welding, by solvent trated in the drawings, in which: softening, or by heat fusion. sheets together at those points. Such a bond can be ob FIG. 1 represents a side view, in section, of a ?lter el~ 25 The ?lter sheet cascade and spacer composite 40, ement in box form including a dual-?lter cascade, in best seen in FIG. 3, is composed at a ?rst coarse ?lter accordance with the invention; FIG. 2 represents another side view, partly in section, of the ?lter element of FIG. 1, showing the side caps on the ?lter housing; sheet 41 of extruded polypropylene netting (Vexar), FIG. 4 represents an isometric view of an embodi and 27 percent open area. The weft mono?laments and pore size about 1500 microns. The spacer 44 is also made of extruded polypropylene netting (Vexar), of 30 the same pore size, about 1,500 microns. The second FIG. 3 represents a view in detail of a portion in sec filter sheet 42 is made of open-mesh square-weave tion shown in FIG. 1 of the ?lter sheet cascade of the polyester mono?lament fabric having a pore opening of 40 microns, a mono?lament ‘diameter of 40 microns invention; ment of ?ler element in bag form including a dual ?lter 35 the wrap mono?laments are backed together by heat cascade in accordance with the invention; setting at their points of crossing de?ning ?xed 40 FIG. 5 represents a longitudinal section of the ?lter micron pores at their interstices. element of FIG. 4, taken along the line 5-5 and look The two filter sheets 41, 42 of the ?lter cascade are ing in the direction of the arrows; and in corrugated form, for an increased surface area in the FIG. 6 represents a cross-section of the ?lter element 40 limited space of ?uid chamber 4, and the tips of the of FIG. 4, taken along the lines 6-6, and looking in the corrugations abut and are held in place by the project direction of the arrows. ing sections 8 and 11 of the housing portions 2 and 3. The ?lter element of FIGS. 1 through 3 is composed ' The edges 32, 33 of the ?lter sheet cascade run right of a housing 1 having ?rst and second housing portions to the ends of the sides 12 and 13. 2 and 3 defining a fluid chamber 4 therewithin. A ?uid 45 The housing channel portions 2 and 3 are open at port 5 is at the base of housing channel portion 2, and their sides and, as best seen in FIG. 2, de?ne openings a ?uid port 6 is at the base of housing portion 3. It will 28, 29 leading into the ?uid chamber 4 of the housing be seen that these ports are coaxial. The port 5 serves 1. The openings are closed off by side caps 30, 31 as a ?uid inlet, and the port 6 as a ?uid outlet, and ?ow which are bonded to the housing portions 2 and 3 and is only in the direction from port 5 to port 6, because also to the edges 32 and 33 of the ?lter sheet cascade of the arrangement of the two ?lter sheets in the cas and spacer composite 40, extending along the openings cade, as will be seen. from end to end between the mating sections 9, 10, 12 The inlet port 5 is housed in a spiked tube 7 which and 13 of the housing portions. This closes off the other is designed to pierce a blood bag stopper for use in two side edges of the ?lter sheet cascade to ?uid ?ow, 55 blood transfusion. Housing portion 2 has an internal and restricts flow between the two portions 34, >35 of projection or rib 8, extending from one side 9 to the ?uid chamber 4 in the housing via the pores in each of other side 10, and housing portion 3 has a like internal the ?lter sheets in the ?lter sheet cascade 40. Thus, all projection 11 extending from one side 12 to the other ?ow between ?uid ports 5 and 6 of housing 1 must pass side 13. These serve as supports extending across the through each of the two ?lter sheets in the direction 41, corrugations of the three-component ?lter sheet cas 42 as is evident from FIG. 3. cade and spacer composite 40, serving as the ?lter. The assembly of the box ?lter element of FIGS. 1 to Each housing portion 2 and 3 is generally channel 3 is as follows. It will be seen on reference to FIG. 1 shaped, with opposed sides 9 and 10 extending out that the sides sections 9, 10 12 and 13 of each housing wardly from the base of portion 2, and opposed sides 65 portion 2, 3 have a special construction which ensures 12 and 13 extending outwardly from the base portion a ?uid-tight seal between the housing portions when 3. The bases of housing portions 2 and 3 are each pro they are bonded together. ‘The opposed sides 9, 10 of vided with ?uid ?ow channels 14. Portion 2 has on housing portion 2 meet and abut like sides 12, 13 of the 3,765,537 8 exactly as shown in FIG. 3, with the ?lter sheet 41 out other housing portion 3. Portion 2 has one pair of each ermost and spacer 44 innermost in the closed con?gu side of side-locating ?ngers l5, and portion 3 has two ration shown in FIGS. 4 to 6. The corrugated shingled pair on each side of side-locating ?ners 16, receiving composite 60 is heat-sealed at 52 along its four sides ?ngers l5 therebetween to ensure that the portions ?t snugly together in the correct position to hold the ?lter (or along three sides, if folded on itself). The thus enclosed ?lter sheet cascade 60 has an outlet line con sheet cascade 40 in place. nection via the tube 53 extending into its open interior The sides 9, 10, 12 and 13 are each slightly longer space 54, and terminating in a caged tip 55. The only than their combined length after they are bonded inlet into the interior space 54 is via the ?lter sheet cas togher. When portions 2 and 3 are ?tted together, the sides 9, 10 are readily fused to sides l2, l3, respec 10 cade 60. This type of ?lter element is especially useful tively, to produce an integral one-piece structure at the in a ?exible bag-type of ?lter unit, the bag 56 being shown in dashed lines in FIGS. 4 and 5. The other end seal 36, FIGS. 1 and 2. Internally of the sides 12, 13 in of the bag 56 which can be the blood bag itself can have housing portion 3 are the projecting members 20, 21 an inlet tube 57, for reception of blood. It is also possi which extend all the way to the interior wall at 26, 27 15 ble to have a spiked inlet tub 57 onto the outside of of the housing portion 2. composite 60 in bag 56, in which case it can be heat In assembly, the edges 22, 23 of the corrugated ?lter sealed to the bag 56 in the same manner as to the ?lter sheet cascade and spacer composite 40 are folded element. This assembly can then be plugged into a around the projecting members 20, 21 of housing por blood bag, as in the case of the ?lter element of FIGS. tion 3 into the sockets 24, 25 between sides 12, 13 and the projecting members 20, 21, where they are held se 20 1 and 2, with ?lter sheet 41 outermost and spacer 44 curely. Housng portion 2 is then ?tter over the portion innermost. The type of ?lter element shown in FIGS. 4 to 6 is es» 3, and presed down smartly against the ?lter sheet cas cade and combined spacers, pinching the three sheets pecially useful for transfusion blood ?ltration, in which at 26, 27 against the tips of projecting members 20, 21, and holding the three sheets ?rmly in place by the tight case it can be built into a standard blood bag, but it can 25 also be attached to any type of blood storage reservoir engagement between the inner wall of the housing por tion 2 and the ends of the members 20, 21. The project or receptacle. The corrugated con?guration of the filter sheet cas ing members 20, 21 are then integrated through the cade in this element provides high surface area, and the shingled arrangement of the corrugation makes it possi pores of the spacer 44 and the two ?lter elements 41, 42 at 26, 27 to the wall of the housing portion 2, form 30 ble to provide a ?at pouch without the need for a core support, because the spaces between the shingles act as ing a ?uid-tight seal therebetween, and closing off both conduits while at the same time the shingled overlap sides of the ?lter sheet cascade to ?uid ?ow. The sides ping structure provides structural support. The support 9, 10 of housing portion 2 can also be bonded to the or spacer sheet 44 of the two-?lter cascade is of heat sides 12, 13 of the housing portion 3 by fusion, such as by ultrasonic welding, at the same time or thereafter, 35 softenable material, which softens at a lower tempera ture than any of the two-?lter sheets composing the so that the two housing portions 2, 3 are sealed to gether, preventing fluid leakage to the outside of the cascade, so that the ?lter sheets 41, 42 are not affected ?lter assembly. under the conditions at which the spacers soften, so that the latter can be fused together in a leak-tight heat Next, the side caps 30, 31 are bonded across the opening 28, 29 into the housing portions 2, 3 and to the ?lter sheet cascade and spacer composite edges 32, 33, 40 seal through the ?lter sheet pores without deleteriously affectng the ?lter sheets. The heat seal is easily effected by high frequency heat, and all heat seals can be formed simultaneously, including the heat seals with bonding the ?lter sheet sides and spacers to the side caps, and completing the ?xing of the ?lter sheet cas the tubes. cade and spacer 40 in place in the ?uid chamber 4, as well as the seals between the ?lter sheet cascade and 45 Having regard to the foregoing disclosures, the fol lowing is claimed as the inventive and patentable em the four side walls of the housing. This can be done us bodiments thereof: ing, for example, an adhesive, or a melt of adhesive or 1. A blood ?lter element cascade which can be used resin or other potting composition, or by fusing the end in blood transfusions without blockage, and which is caps. The ?lter element is now complete, and ready for 50 The ?lter element is operated in line, as follows. The spiked tip is plunged into the stopper of a blood bag, capable of removing large particles, such as blood clots, and also small particles down to approximately 20p. in size, while passing platelets, red blood cells and thereby permitting blood to ?ow from the bag through at least a substantial proportion of white blood cells, use. comprising in combination, two ?lter sheets, arranged chamber portion 34. The blood then ?ows through the 55 in downstream ?ow sequence in order of progressively the inlet port 5 and enter the channel 14 ?owing into increasing ?neness; ?lter sheet cascade 40 via ?lter sheet 41, ?lter sheet 42 and spacer 44, and enters the chamber portion 35, whence it emerges via channel 14 from the housing via port 6. ' Line connections can be made at ports 5, 6 in any de sired manner. Luer locks also can be used, if desired. The ?lter, element 50 of FIGS. 4 to 6 has as the ?lter a composite 60 of a two component ?lter sheet cascade (sheets 41, 42 and spacer sheet 44) in corrugated shin gled form, with corrugated folds 51 lying in the plane of the ?lter element in overlapping fashion. The two ?l ter sheets 41, 42 and separating spacer 44 are arranged a. the ?rst ?lter sheet comprising coarse open netting of plastic ?lamentary material having a pore size 60 within the range from about 800 to about 4,000 mi crons, small enough to remove blood clots, and coarse enough to do so without being subject to blocking by the blood clots that are strained out, and b. the second ?lter sheet comprising an open mesh fabric of plastic mono?laments, having a pore size within the range from about 20 to about 50 mi crons, capable of removing microemboli, lipids and 3,765,537 9 debris, and gas emboli, that pass through the ?rst ?lter element while passing platelets, white blood cells, and red blood cells. 2. A blood ?lter element cascade according to claim 1, in which the ?rst ?lter sheet is an open-mesh netting 10 from the ?ltrate-?ow side of the ?lter element to the outlet. 18. A disposable blood ?lter unit according to claim 11, in which the housing is composed at least of first and second generally channel-shaped housing portions, prepared by extruding, casting, or molding plastic and having an integral ?lamentary structure. sides, the ?rst and second housing portions having op 3. A blood ?lter element cascade according to claim posed sides, with mating sections abutting and bonded 2, in which the plastic material is selected from poly propylene, polyethylene, polyester, polyamide, and polycarbonate. de?ning therebetween a ?uid chamber open at two in a ?uid-tight seal to each other, and the blood ?lter 10 element cascade in sheet form extending across the ?uid chamber, across the line of ?uid ?ow between the - 4. A blood ?lter element cascade according to claim ?uid ports and held at opposed side portions to at least one of the ?rst and second housing portions, and side 1, in which the second ?lter sheet is a woven sequare caps bonded to the ?rst and second housing portions in weave mesh of plastic mono?laments having a pore size within the range from about 20 to about 50 microns, 15 a ?uid-tight seal across the open sides of the ?uid chamber and to the sides of the blood ?lter element the ?laments being locked in place at their crossing points. cascade extending along such open sides, the side caps and the housing portions holding the sides of the blood 5. A blood ?lter element cascade in accordance with ?lter element cascade, positioning the blood ?lter ele claim 4, in which the mono?laments have a diameter within the range from about 25 to about 50 microns. 20 ment cascade across the ?uid chamber, and sealing all the sides of the blood filter element cascade to the 6. A blood ?lter element cascade in accordance with housing, so that the ?uid ?ow between the ?uid ports claim 4, in which the plastic mono?laments are of poly must pass through the blood ?lter element cascade. ester plastic. 19. A disposable blood ?lter unit in accordance with 7. A blood ?lter element cascade in accordance with 25 claim 18, having four sides, two of the sides being de claim 1, in which the ?laments are heat set to lock them ?ned by the side caps and two of the sides by the first in place. and second housing portions, and the blood ?lter ele 8. A blood ?lter element cascade according to claim ment cascade is in four-sided sheet form. 1, in which the two ?lter sheets are in close juxtaposi tion, and corrugated or convoluted to provide a high 30 20. A disposable blood ?lter unit in accordance with claim 19, in which the blood ?lter element cascade is surface area to ?ow. in four-sided corrugated sheet form. 9. A blood ?lter element cascade according to claim 21. A disposable blood ?lter unit in accordance with 8, in which second ?lter sheet is juxtaposed to a spacer claim 18, in which the first and the second housing por having a pore size at least as large as the ?rst ?lter sheet, and within the range from about 800 to about 35 tions and the ?uid ports therein are arranged so that the ?uid ports are coaxial. Y > 10,000 microns. 10. A blood ?lter element cascade according to claim 9, in which the spacer has an uneven surface so as to provide drainage and prevent blocking of the ?lter 22. A disposable blood ?lter unit in accordance with claim 18, in which all of the housing portions are of plastic material. 23. A disposable blood ?lter unit in accordance with claim 22, in which the plastic material is a thermoplas l l. A disposable blood filter unit comprising a blood tic resin. filter element cascade according to claim 1, and a hous 24. A disposable blood ?lter unit in accordance with ing having an inlet and an outlet and line connections claim 23, in which the thermoplastic resin is polypro thereat for ?uid ?ow into and out from the housing, the pylene. blood ?lter element cascade being disposed in the 45 25. A disposable blood ?lter unit in accordance with housing across the line of flow therebetween so that claim 22, in which the housing portions are integrated ?uid ?ow therebetween must pass through the ?lter el together to form a one-piece housing. ement cascade. 26. A disposable blood ?lter unit in accordance with 12. A disposable blood filter unit in accordance with claim 18, in which the blood ?lter element cascade is 50 claim 11, in which the blood ?lter element cascade is held at opposed side portions between the mating sec sheet by the spacer. in the form of a cylinder, and one line connection has a direction ?uid ?ow connection to the interior of the ?lter cylinder. tions of the ?rst and second housing portions. ‘ 27. A disposable blood ?lter unit in accordance with claim 26, in which the blood ?lter element cascade is 13. A disposable ?lter unit in accordance with claim integrated to the mating sections by fusion thereof 11, having a housing made in two portions bonded to 55 through the pores of the blood ?lter element cascade. gether. _ 14. A disposable ?lter unit in accordance with claim 13, made of plastic, with the portions fused together 28. A disposable blood ?lter unit in accordance with claim 18, in which the side caps are integrated to the housing portions to form an integral one-piece ?lter unit. 15. A disposable ?lter unit in accordance with claim 60 29. A disposable blood ?lter unit in accordance with 14, including line connection integral with the housing. claim 18, in which each of the housing portions in 16. A disposable ?lter unit in accordance with claim cludes at least one projecting portion engaging and sup 14, having the ?lter unit bonded to one housing por porting opposite sides of the blood ?lter element cas tion. cade, and extending with the blood ?lter element cas 17. A disposable ?lter unit in accordance with claim 65 cade across the ?uid chamber. 16, having the ?lter unit bonded to one housing portion 30. A disposable blood ?lter unit in accordance with at the outlet with a direct fluid ?ow line connection claim 18, in which one housing portion comprises a into one piece. 3,765,537 12 11 projecting member holding the opposite end portions tending internally of the two abutting portions, and en of the blood ?lter element cascade against the other gaging the blood ?lter element cascade at a portion near its edge. 32. A disposable blood ?lter unit in accordance with housing portion. 31. A disposable blood ?lter unit in accordance with claim 30, in which the mating sections of each housing portion have ?rst projecting members extending to wards each other, and abutting endwise, with the first housing portion having second projecting members ex claim 30, in which the second projecting members also hold the blood ?lter element cascade tightly against an internal wall of the second housing portion. * 20 25 30 35 45 50 55 65 * 'll * * Dedication 3,765,537.—David J. Rosenberg, Glen Cove, NY. DUAL BLOOD FILTER. Pa tent dated Oct. 16, 1973. Dedication ?led Dec. 31, 1981, by the assign ee, Pall Corp. Hereby dedicates t0 the Public claims 1 through 17 of said patent. [O?icial Gazette November I, 1983.] ‘822$? . M ‘UNITED STATEs-‘BATENTIoFFiCE J CERTIFICATE '- OF *CORRECTIGN " ' Patent M 3,765,537 Invv'entor(s) David J' Rosenberg 15 v 191117 ' Dated October 16,1973” _ 1-1? It is certified that error appears in the above-‘~ideritified patent‘ and that said Letters Patent are hereby corrected as shown below: Goes page, line 8 '7 " : "Ser. No. 38,356H should be -— Ser. No. “f” 88,355 ~-_ Column 1, line 19 :‘ Column 1, line 6-1 v ' ~> C‘ "attribu-ed" should bé "attributed - Column 3, lines-'9 and ‘10: Column 5, lit-1e . "an" should be —- and —-_'-f; , - Column 4, line 44' -- "tp" should be -- lo —— . - Column 2,l1mé_1_1_;_ v‘ _ "tend'ecny" should be "fendency - : "filerf' should be -- ?lter ~ ' : "dzhe" should be —- Other — Column 6, line 17 : "n-merrlber" should be --_ members — Colurhn 6, line 26 : "at'_' ‘should be -é of -- Column 6; line 63 -_ 2 "sides" should be —- side : "pair" should be -- pairs-"v: : "finers" should be -- ?nger,s_~-- ' : . "togher" should be," together - 1' "Housng" should be" Housing." , } : ’ "presed" should be -- pressed -— Column-‘7, line 3 1 ' Column 7, line Y ‘I \ Column 7, line 9'.- ‘c?lumn 7, line 21 _ Column 7, line 22" - . I a "'"i ' _‘ H 2-478 CIP Eo-wso ' ' (owe) f UNITED STATES PATENT OFFICE: - - H CERTIFICATE OF CORRECTEQN Patient: No. 1L» ‘ ’ ' ' - .4‘ 3,765,537_ Dated October 15, 1973 I v > -Page‘* 2 Inventor(s) S David J- Rosenberg It is certified that error appears‘ in the above-identified ‘patent V and that said Letters Patent are hereby corrected ‘as shown‘ below; r“ , ‘ I ‘ ' ' - Y > '1 Column 8, hne'15' , : "tub" should be -- tube -- Column 8, line-29 v ' : "corrugation" should be -— corrugations —-v Column 8, line_.41 Column 9, ' claim 4, Column 9, 7 ' : "affectng" should be — affecting _- _: "sequare" shouldbe ._-—4squar'e - 1 "direction" should be -— direct — i line ‘13 . _ - claim '12, line ‘52' 7 -- Column 9, claim 15, ' lineI-GZ , _ - i > . V v: '' "connection" should be -'_-‘c_onnections — Signed and sealed ehis 18th'dsy of February 1975. (SEAL) Argest’. ;,> RUTH c. MASON: Attesting Officer 1- ' ' - c. MARSHALL DANN , ‘ Commissioner of Patents‘ and Trademarks .1 ‘
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