Manufacture of blood filter

Manufacture of blood, filter

BAXTER TRAVENOL LABORATORIES, INC.

C. 55981

It has been recently determined that there are many situations when stored, donated blood, as well as other types of blood and blood components, should be fil5 tered to remove microemboli of aggregated blood elements and the like, prior to administration to a patient. In particular, older, stored blood which is nearing its expiration date has been found to be greatly improved by filtering, to prevent the microemboli from lodging in the lungs, brain, 10 and elsewhere, thus avoiding various degrees and types of injury to the patient.

A considerable number of blood filters are now commercially available for use with stored, whole blood, or for reprocessing fresh blood in heart-lung machines, as 15 well as blood which has passed through a cardiotomy sucker.

In a blood filter, it is, of course, desirable that the filter remove as many particles as possible which are larger than red cells ’which have an average size of 7 microns), while at the same time exhibiting a rapid flow 20 rate of blood through the filter, and a high capacity to process several units of blood. Accordingly, the filter does not have to be replaced excessively often as a patient is receiving a large amount of blood.

Furthermore, a filter should be susceptible to 25 automated commercial production techniques, so as not to be excessively expensive. It must also be reliably leakfree. Also, it must be free of shunt passages which permit blood to pass around the filter element without filtering action.

Such a filter is.described in Israel patent specification No. 51209, from which the present application was divided out. Said filter exhibits excellent high-flow characteristics,. At the same time .it provides surprisingly excellent levels of particle removal from blood. .Furthermore, it is susceptible to reliable, automated sealing against blood shunting and to sterile sealing of the contents from the exterior, on a low-cost basis.

The present invention provides a method of manufacturing a filter .for blood and the like which comprises assembling a stack of filter pads including thermoplastic fibers, heat sealing the peripheries of said pads in the stack to form an integral filter unit defining an integral periphery, and inserting said filter unit into a filter housing.

In the assembly of the filter, sheets of filter material are stacked to form a plurality of layers. A heat sealing.device such as a sonic sealer is then applied to the stack to stamp a circular or other closed peripheral seal. The sealing operation causes the plastic pad materials to become molten, thus joining the layers to each other in the area of the seal. The sealed area then hardens to define a generally stiff and nonporous peripheral flange for the filter stack, which can act as a sealing gasket, cooperating with the outer casing to provide a peripheral.seal against the filter.

Simultaneously with the heat sealing, or thereafter, the integral filter unit is cut away about its periphery from the rest of the filter material. It is then washed and processed for installation into a housing.

It has been found that nonwoven filter pads for use in the stack, and in particular filter pads made of polyester fibers., give.excellent results. Polyester fibers have the advantage of being easily sonic-sealed. However, it is contemplated that other fibrous materials such as nylon, acrylic materials such as poly(methyl methacrylate), cellulose ester materials such as cellulose acetate, and polypropylene can also be used. Nonthermoplastic fibrous materials such as rayon and glass can also.be utilized to construct devices in accordance with the second aspect of this invention, or in the first aspect of this invention if the nonporous peripheral flange is made by molding an adherent rubber or plastic ring about the periphery of the filter pads.

In the drawings, Figure 1 is a perspective view of one embodiment of the filter produced in accordance with this invention, adapted specifically for the processing of donated, stored blood.

Figure 2 is an enlarged, sectional view of the filter .produced in accordance with this invention.

Figure 3 is an elevational view of a stack of filter pads used in the device of Figures 1 and 2, being joined together at their peripheries to form an integral filter unit, prior to assembly into the filter housing as shown in Figure 2.

Figure 4 is a fragmentary sectional view of a portion of the structure of Figure 2, shown prior to a heat sealing step for sealing the housing, the completion of which is as shown in Figure 2.

Referring to the drawings, 3 filter is shown defining a housing 12, made of a pair of mating shells 14, 16. The filter may be connected to a blood administration set or the like for use, for receiving blood from a blood bag. Shell 14 defines an inlet 18 for fluids to be filtered, while shell 16 defines an outlet 20 for filtering fluid. Shells 14, 16 also respectively define mating flanges 22, 24, which may fit together by sonic sealing or the like at area 26. Each shell 14, 16 defines a series of rad.ial vanes 27, 28, for the purpose of defining flow channels to distribute fluid between the filter material and inlet 18, as well as outlet 20.

Integral filter unit30 comprises a stack of filter pads of thermoplastic fibers, positioned within housing and joined together by a peripheral flange 32, which may be prepared by heat sealing, forcing the periphery of all of the pads of stack 30 into an integral, fused mass forming flange 32, This process is indicated by Figure 3, showing how tubular heat-seal dies 34, 36 can pinch the pads together at the area of peripheral flange 32 and effect heat sealing, by means of sonic sealing, R.F. sealing, or any other desired technique, so that the stack of pads 30 form an integral mass, surrounded by fused flange 32.

Thereafter, stack 30 is inserted between shells

14, 16, and the shells are heat sealed together about flanges 22, 24 in the manner shown in Figure 2. Gripper rings 38 molded on flanges 22, 24 in shells 14, 16 press against the flange 30 of stack 30 to provide a mechanical seal between stack 30 and shells 14, 16. This prevents the formation of shunting channels leading around stack 30. Optionally a heat seal may be provided in the same area, along with the mechanical seal.

In the specific embodiment shown, stack 30 comprises five different types of filter pads.

Filter pad 40 comprises the first pad of the stack. Typically, it is made of nonwoven, polyester fibers of the largest fiber diameter in the filter. Specifically, the fibers may be 15 denier (0.00392 centimeter in diameter), although the diameter may vary substantially depending upon the desired results for the filter. Pad 40 may typically be on the order of 1 to 1 1/2 inches thick (specifically about 11/4 inches in thickness) prior to being sealed together into stack 30, which results in compression and reduction of the thickness.

Prior to assembly, the layer of nonwoven material from which fibrous pad 40 is manufactured may preferably be coated on both sides with a binder material such as a water emulsion of a self-crosslinking acrylic material, specifically Rohm & Haas Rhoplex HA 12.

Approximately 2.5 ounces of binder material solids may be applied per square yard of fibrous material of pad 40. The upper surface 42 of fibrous pad 40 is sprayed with a 25 percent solids emulsion, while the bottom surface 44 of pad 40 may be sprayed with a 5 percent solids emulsion, so that about 5 times as much binder material is applied to surface 42 than to surface 44.

Thus, when the fibrous pad 40 is compressed by the sealing step of Figure 3, and further compressed by being placed in housing 12, most of the compression takes place in the lower portion of pad 40, in the vicinity of bottom surface 44, while the fibrous material in the vicinity of surface 42 remains in less compressed condition. This provides a natural filtering gradient, selective for removing of the largest particles first as fluid passes through pad 40.

The total typical weight per square yard of the material of pad 40 after binder application is about 9 to 11 ounces, and the fibers occupy about 4 percent of the pad volume.

The second filter pad 46 may comprise nonwoven polyester fibers of about 6 denier, i.e. a fiber diameter of 0.00264 cm. Of course, other size ranges and materials for filter pad 46 can also be used in accordance with this invention.

Typically, before sealing into stack 30 as shown in Figure 3, the uncompressed thickness of filter pad 46 is about 3/4 to 1 inch, or specifically, 7/8 inch. The material may be treated with the same binder agent and in a manner similar to filter pad 40, with about one fourth of the weight of the resulting product constituting binder material. The overall weight per square yard of the material of pad 46, after application of the binder material, may be in the order of 3.5 to 4.5 ounces, specifically about 4 ounces, and the pad volume occupied by its fibers may also be about 11 percent.

The next two layers of filter pads 48a, 48b may be of the same polyester fiber. Before compression into stack 30 each layer 48a, 48b may be about 0.03 to 0.07 inch thick, specifically 0.05 inch. This material־tends to compress much less upon processing and placement into housing 12 than the previous layers. It also can have a fiber denier of 6, but it may be a denser material than pad 46, weighing from about 6.5 to 8.4 ounces (e.g. 8 ounces) per square yard, with the fibers occupying about 11 percent of the pad volume. Typically, the materials of layers 48a and 48b are not treated with a binder. The specific filter pads 48a, 48b used may contain a polyester spunbonded scrim material as a support.

Filter pad 50 may typically contain a mixture of fibers, 50 percent by weight of which are from 3 to 6 denier 10 (i.e. strand diameters of 0.00171 cm. to 0.00264 cm.), and percent by weight of 1.5 denier fibers (a diameter of 0.00122 cm.). The material is typically made of polyester fibers, having an uncompressed thickness of about 0.03 to 0.05 inch (specifically 0.04 inch). It may have a density of about 6 ounces per square yard, and the fibers may occupy about 15 percent of the pad volume. The material is supported with a nonwoven rayon scrim material, and, in the specific embodiment, it is not treated with a binder material.

Finally, last pad 52 may.be a polyester fiber mixture of 50 percent by weight of fibers having a denier of about 3 or 4, and 50 percent by weight of fibers having a denier of 1.5. The pad may have an uncompressed thickness of about 0.05 to 0.06 inch, and is supported on a polyester woven mesh scrim material. The density may be about 12 ounces per square yard, and the fibers occupy about 30 percent of the pad volume. No binder is typically used.

Of course, other filter pads, having different characteristics and properties may be used in this invention, the above description being purely for exemplary purposes.

The overall compressed thickness of filter stack 30, as installed in casing 12, may be about 3/4 to 1 inch in this embodiment, specifically 7/8 inch.

After the filter pads are sealed together into stack 30 by means of sonic sealing member 34, 36, and stack 30 is cut away from the rolls of bulk material, either simultaneously with the sealing process or later from the layers of bulk filter material, stack 30 is thoroughly washed. The washing solution may comprise one quarter percent by weight each of Dupanol RA detergent material sold by the DuPont Chemical Company, and sodium carbonate, in distilled water. This is followed by rinsing stack 30 three times in distilled water, and drying stack 30 in a tumble dryer at a temperature below the softening temperature of the softening or degradation temperature of the plastic fibers in stack 30.

After drying of pad 30, the bottom surface 37 of the pad is heat-sintered prior to placing the stack into casing 12. This tends to cause individual, free fibers and other particles to adhere to the pad, reducing the amount of particulate matter falling out of the pad during use. Generally, the heat-sintering step can be accomplished by exposing the bottom surface 37 of stack of pad 30 to hot air at a temperature of at least about 380° F., and preferably about 400° F., for a few seconds, for example five seconds.

Thereafter, st^ck 30 is placed into housing 12, with shells 14, 16 being brought together first as shown in Figure 4. Shells 14, 16 may be sonically sealed together, for example by the use of a series 400 sonic sealer from the Branson Sonic Power Company of Danbury, Connecticut. Sonic sealing horn 54 presses shell 14 against flange 32 and lower shell 16. Simultaneously, the sonic sealing energy causes annular plastic ridge 56 to melt, resulting in the fusion of flanges 22 and 24 together in zone 26, as shown in Figure 2.

For sealing of the shells 14, 16 of casing 12, the above described Branson sonic sealer can be used with the silver booster, at a power control of 85 percent, a weld time of about 1.5 seconds, a pressure of 30 p.s.i., and a hold time of 1 second.

For sealing of the various filter pads to form flange 32 and integral stack 30, the same machine may be used with the green booster, with a power control of 85 percent, a weld time of about 5 seconds, a.pressure of about 50 p.s.i., and a hold time of about 6 seconds.

The horn of the sonic sealing device may be adapted to cut stack 30 away from the rolls of layers of filter material, simultaneously with the sealing operation which forms flange 32.

Also, the horn of the sonic sealing device desirably contains a resilient plug to compress the fibers, particularly of filter pads 40 and 46) during the sealing operation. This can reduce the overall thickness of stack 30, resulting in a flatter filter having a lower blood volume.

The filter described above is generally capable of processing 5 or 10 units of blood without needing replacement, and has successfully removed about 64 percent of 12 micron particles; 94 to 95 percent of 16 micron particles;

to 99 percent or more of 20 to 32 micron particles; and all larger particles.

Casing 12 may be about 9 cm. in diameter. However, the filter of this invention, although small, exhibits a high flow capacity and excellent levels of particle removal, while being susceptible to automated and inexpensive manufacture.

The above has been offered for illustrative purposes only, and is not for the purpose of limiting the invention of this application, which is as described in the claims below.