Leukocyte-removing filter device and system and method of using thereof

• US 5,543,062 A
• Filed: 11/15/1995
• Issued: 08/06/1996
• Est. Priority Date: 10/07/1992
• Status: Expired due to Term

• Current Assignee: Asahi Kasei Medical Co., Ltd. (Asahi Kasei Corporation)
• Original Assignee: Asahi Medical Co. Ltd. (Asahi Kasei Corporation)
• Inventors: Nishimura, Takao
• Primary Examiner(s): Kim, John
• Application Number:
  US08/559,726
• Time in Patent Office: 265 Days
• Field of Search: 210/252, 210/257.1, 210/321.75, 210/321.84, 210/433.1, 210/435, 210/443, 210/453, 210/488, 210/496, 210/497.01, 210/767, 210/782, 210/787, 210/789 , 210/800, 210/806, 422/101, 494/16, 494/20, 494/21, 494/37, 494/36, 604/4, 604/5, 604/406, 604/408, 604/410
• US Class Current: 210/782
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0222 and filter bypass
• CPC Class Codes: A61M 1/0227 and means for securing the filter against damage, e.g. during centrifugation
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 2202/005 residue retained by the filter due to size
• CPC Class Codes: A61M 2202/0439 White blood cells; Leucocytes lymphocytes A61M2202/0407

Abstract

Disclosed is a leukocyte-removing filter device comprising (a) a casing having an inlet for blood and an outlet for leukocyte-removed blood, which are both located in a top portion of the casing, and (b) a filter medium disposed in the casing so as to divide the internal space of the casing into an inlet-side chamber communicated with the inlet and an outlet-side chamber communicated the outlet. By virtue of the locations of the inlet and outlet on the top portion of the filter device, the leukocyte-removing filter device of the present invention is advantageous not only in that the filter device can be fittedly and stably accommodated into a centrifuge cup together with a plurality of blood bags and circuit tubes connecting the filter device and blood bags, so that a centrifugation can be efficiently conducted without the danger of damaging the filter device and the blood bags, but also in that the operation of expelling the air from the filter by filling the filter with blood can be very readily conducted simply by allowing blood to flow into the filter without any additional burdensome operations. The leukocyte-removing system comprising the above-mentioned leukocyte-removing filter device is also disclosed.

Claims

1. A leukocyte-removing filter device comprising:

(a) a flat casing comprising opposite flat main walls fluid-tightly connected by a side wall structure to define an internal space of said casing, each main wall vertically extending and having a width and a height, said side wall structure having a width defined by a distance between said opposite flat main walls, wherein said casing has a top and a bottom portion which are spaced apart vertically of said casing, and wherein the width or height of each main wall, whichever is shorter, is at least two times the width of the side wall structure,

said top portion having an inlet for blood and an outlet for leukocyte-removed blood, and

said top portion vertically extending from a top end of said casing over a length one-third or less the entire vertical length of the casing as measured from the top end of the casing; and

(b) a filter medium comprising at least one filter material sheet extending within said internal space of the casing along said flat main walls to partition said internal space into an inlet-side chamber communicating with said inlet and an outlet-side chamber communicating with said outlet, said outlet-side chamber not discontinuously varying in horizontal cross-sectional area more than 10% over the entire inner space of the outlet-side chamber from its inner bottom portion to its inner uppermost portion.

2. The filter device according to claim 1, wherein the casing has a central axis vertically extending from said top portion to said bottom portion, and the inlet opens in a direction along a first line and the outlet opens in a direction along a second line, said first and second lines each forming an angle with the central axis and each angle being independently not more than 90°

inclusive of 0°

relative to the central axis.

3. The filter device according to claim 2, wherein each of said inlet and said outlet opens in a direction substantially parallel to the central axis of the casing.

4. The filter device according to claim 2, wherein said inlet and said outlet are positioned in a symmetrical relationship with respect to a plane containing the central axis of the casing and extending in parallel to the main wall on the side of said outlet-side chamber.

5. The filter device according to claim 1, wherein the overall outer surface of said casing is substantially free of convexo-concave portions and sharp projections, rendering smooth said overall outer surface, and wherein said casing has an inner volume of from 1 ml to 150 ml and has the following outer dimensional characteristics:

a width of not more than 15 cm, a height of not more than 25 cm and a thickness of not more than 2 cm.

6. The filter device according to claim 1, wherein the inner uppermost portion of said outlet-side chamber decreases in horizontal cross-sectional area toward said outlet.

7. The system according to claim 1, wherein the bottom, inside portion of the sidewall structure is provided with a groove for accommodating the bottom portion of the filter material sheet.

8. The system according to claim 1, wherein the internal walls of the sidewall structure of said inlet-side chamber and said outlet-side chamber are provided with pressing means.

9. The system according to claim 8, wherein the pressing means are a plurality of projections extending from the sidewall structure toward the filter medium.

10. The system according to claim 8, wherein the pressing means is a loose, resiliently disposed mesh-like structure.

13. The system according to claim 1, further having an anticoagulant-containing blood collection bag fluid-tightly connected to said inlet connecting means and having at least one satellite bag fluid-tightly, aseptically connected to said blood collection bag.

11. A leukocyte-removing system comprising:

a leukocyte-removing filter device comprising;

(a) a flat casing comprising opposite flat main walls fluid-tightly connected by a side wall structure to define an internal space of said casing, each main wall vertically extending and having a width and a height, said side wall structure having a width defined by a distance between said opposite flat main walls, wherein said casing has a top and a bottom portion which are spaced apart vertically of said casing, and wherein the width or height of each main wall, whichever is shorter, is at least two times the width of the side wall structure,

said top portion having an inlet for blood and an outlet for leukocyte-removed blood, and

said top portion vertically extending from a top end of said casing over a length one-third or less the entire vertical length of the casing as measured from the top end of the casing; and

(b) a filter medium comprising at least one filter material sheet extending within said internal space of the casing along said flat main walls to partition said internal space into an inlet-side chamber communicating with said inlet and an outlet-side chamber communicating with said outlet, said outlet-side chamber not discontinuously varying in horizontal cross-sectional area more than 10% over the entire inner space of the outlet-side chamber from its inner bottom portion to its inner uppermost portion,

inlet connecting means fluid-tightly connected to the inlet for aseptically connecting a part preceding the leukocyte-removing filter device to said inlet,

at least one satellite bag, and

outlet connecting means for fluid-tightly directly connecting said outlet of the leukocyte-removing filter device to said at least one satellite bag, said outlet connecting means comprising a tube,

wherein said leukocyte-removing system is entirely in an aseptic state.

12. The system according to claim 11, further having an anticoagulant-containing blood collection bag fluid-tightly connected to said inlet connecting means, and wherein said at least one satellite bag includes a plurality of satellite bags connected in series.

14. A method for removing leukocytes from blood, which comprises the steps of:

(1) providing a leukocyte-removing filter device comprising;

(a) a flat casing comprising opposite flat main walls fluid-tightly connected by a side wall structure to define an internal space of said casing, each main wall vertically extending and having a width and a height, said side wall structure having a width defined by a distance between said opposite flat main walls, wherein said casing has a top and a bottom portion which are shaped apart vertically of said casing, and wherein the width or height of each main wall, whichever is shorter, is at least two times the width of the side wall structure,

said top portion having an inlet for blood and an outlet for leukocyte-removed blood, and

said top portion vertically extending from a top end of said casing over a length one-third or less the entire vertical length of the casing as measured from the top end of the casing, and

(b) a filter medium comprising at least one filter material sheet extending within said internal space of the casing along said flat main walls to partition said internal space into an inlet-side chamber communicating with said inlet and an outlet-side chamber communicating with said outlet, said outlet-side chamber not discontinuously varying in horizontal cross-sectional area more than 10% over the entire inner space of the outlet-side chamber from its inner bottom portion to its inner uppermost portion;

(2) allowing blood to flow into the inlet of said filter device and pass through said filter medium contained in said filter device to thereby remove leukocytes from the blood, and discharging leukocyte-removed blood from the outlet of said filter device.

15. A method for removing leukocytes from blood, which comprises the steps of:

(1) providing at least one leukocyte-removing system comprising;

(A) a leukocyte-removing filter device comprising;

(a) a flat casing comprising opposite flat main walls fluid-tightly connected to a side wall structure to define an internal space of said casing, each main wall vertically extending and having a width and a height, said side wall structure having a width defined by a distance between said opposite flat main walls, wherein said casing has a top and a bottom portion which are spaced apart vertically of said casing, and wherein the width or height of each main wall, whichever is shorter, is at least two times the width of the side wall structure,

said top portion having an inlet for blood and an outlet for leukocyte-removed blood, and

said top portion vertically extending from a top end of said casing over a length one-third or less the entire vertical length of the casing as measured from the top end of the casing, and

(b) a filter medium comprising at least one filter material sheet extending within said internal space of the casing along said flat main walls to partition said internal space into an inlet-side chamber communicating with said inlet and an outlet-side chamber communicating with said outlet, said outlet-side chamber not discontinuously varying in horizontal cross-sectional area more than 10% over the entire inner space of the outlet-side chamber from its inner bottom portion to its inner uppermost portion,

(B) inlet connecting means fluid-tightly connected to the inlet for aseptically connecting a part preceding the leukocyte-removing filter device to said inlet,

(C) at least one satellite bag, and

(D) outlet connecting means for fluid-tightly directly connecting said outlet of the leukocyte-removing filter device to said at least one satellite bag, said outlet connecting means comprising a tube;

(2) allowing blood to flow into the inlet of said filter device through said inlet connecting means,and pass through said filter medium contained in said filter device to thereby remove leukocytes from the blood, and discharging leukocyte-removed blood from the outlet of said filter device; and

(3) transferring leukocyte-removed blood to said at least one satellite bag through said outlet connecting means.

16. The method according to claim 15, wherein said at least one leukocyte-removing system further comprises a blood collection bag which is directly or indirectly connected to said inlet connecting means fluid-tightly connected to the inlet of said filter device,

which method further comprises, prior to said step (2):

providing a centrifugal apparatus comprising at least one centrifuge cup;

placing the blood to be flowed through said filter device in said blood collection bag of said at least one leukocyte-removing system;

accommodating said at least one leukocyte-removing system in said at least one centrifuge cup of said centrifugal apparatus, respectively, wherein said filter device is held between said blood collection bag and said at least one satellite bag in a vertically directed configuration, or placed on said blood collection bag and said at least one satellite bag; and

actuating said centrifugal apparatus to thereby centrifuge said blood contained in said blood collection bag.