WO1999002269A1 - Centrifuge bowl for autologous blood salvage - Google Patents
Centrifuge bowl for autologous blood salvage Download PDFInfo
- Publication number
- WO1999002269A1 WO1999002269A1 PCT/US1998/014345 US9814345W WO9902269A1 WO 1999002269 A1 WO1999002269 A1 WO 1999002269A1 US 9814345 W US9814345 W US 9814345W WO 9902269 A1 WO9902269 A1 WO 9902269A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- bowl
- recited
- annular
- blood
- internal
- Prior art date
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B7/00—Elements of centrifuges
- B04B7/08—Rotary bowls
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B5/00—Other centrifuges
- B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
- B04B5/0442—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B5/00—Other centrifuges
- B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
- B04B5/0442—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
- B04B2005/0464—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation with hollow or massive core in centrifuge bowl
Definitions
- This invention pertains to centrifuge bowls utilized in extracorporeal blood transfer applications, and more particularly, to a centrifuge bowl that provides for fluid flow therethrough during rotation and that is particularly apt for enhanced autologous blood salvage operations.
- the blood is typically filtered to remove debris and defoamed to remove gaseous components.
- the blood and a wash solution are separately pumped in sequence through a rotating centrifuge to separate and wash accumulated red blood cells.
- the accumulated red blood cells are removed from the centrifuge bowl for subsequent re- infusion to the patient.
- the reduction of blood processing time is advantageous since, in ter alia , it desirably reduces medical personnel time demands and otherwise advantageously allows for expeditious reinfusion of the RBC product to the patient.
- washing of the red blood cells serves to dilute and remove soluble molecules suspended in the plasma, such as plasma-free hemoglobin and anticoagulants (e.g. heparin) . Additionally, activated/nonactivated clotting factors are removed. Further, it is desirable that washing remove activated platelets/white blood cells. Correspondingly, it is desirable to avoid the accumulation of deposits of white blood cells and platelets in the centrifuge bowl during processing so as to reduce any risk of removal of such deposits with the harvested RBCs. (See e.g., Bull et al .
- a primary objective of the present invention is to provide an improved centrifuge bowl and corresponding blood processing system which achieves enhanced washing of separated blood components, and which is particularly apt for autologous blood salvage operations.
- processing rates can be maintained at a relatively high level (e.g., blood fill rates of at least about 300 ml. /min. and wash solution inlet rates of at least about 500 ml. /min.) .
- At least one predetermined, heavier component of the blood to be separated and harvested for reinfusion e.g. red blood cells
- at least one predetermined, heavier component of the blood to be separated and harvested for reinfusion e.g. red blood cells
- the inner layer of undesired compounds reaches a predetermined level (i.e. relative to the rotational axis)
- the undesired components will flow out of the top of the rotating bowl.
- the outer layer of separated components will be "packed” in a substantially uniform manner along the height of the outer layer.
- the vertical surface of the outer layer will progress towards the axis of rotation) during the blood fill cycle, while maintaining a substantially constant density gradient throughout the height of the cylindrical, annular collection region.
- the thickness of the outer layer may advantageously exceed the width of the port of the lateral passageway, wherein the outer layer advantageously extends across the lateral extent of the port prior to a wash cycle.
- the present invention provides for enhanced washing of the outer layer components by introducing the wash solution directly into the bottom of the accumulated outer layer of separated component (s) . That is, washing of the separated component (s) is enhanced as the wash solution passes upwardly, directly therethrough and laterally therethrough (i.e., towards the rotational axis) to the inner layer where it accumulates for removal.
- the flow of the wash solution may particularly enhance removal of plasma-free hemoglobin (e.g. in cases exhibiting significant hemolysis) that may accumulate during the blood fill cycle within the outer layer together with desired red blood cells.
- termination of the blood fill cycle may be triggered either automatically or manually.
- Manual triggering may be based upon user detection of a predetermined color in a transparent outlet flow line from the centrifuge bowl.
- Automatic termination may be provided by positioning an optical assembly, having an infrared light source (e.g. for emitting light of a wavelength that is readily absorbed by red blood cells) and a corresponding light detector, immediately adjacent to the top of the outer centrifuge bowl (e.g. constructed of clear plastic).
- an optical assembly having an infrared light source (e.g. for emitting light of a wavelength that is readily absorbed by red blood cells) and a corresponding light detector, immediately adjacent to the top of the outer centrifuge bowl (e.g. constructed of clear plastic).
- the presence of significant levels of plasma-free hemoglobin within the outer layer comprising accumulated red blood cells can be "detected" so as to result in early termination of the fill cycle.
- the subsequent flow of wash solution directly into the bottom of the accumulated outer layer serves to enhance separation of the plasma-free hemoglobin from the RBCs, and to effectively push the plasma-free hemoglobin out of the bowl during the wash cycle so as to enhance the hematocrit of the harvested outer layer product.
- the source/detector can also be provided to detect if/when the outer layer recedes below the predetermined desired volume so as to trigger subsequent fill and wash cycles, wherein the desired volume and quality of product can be obtained.
- the outer layer may be removed from the centrifuge bowl.
- the centrifuge bowl may be emptied by terminating rotation of the centrifuge bowl and pressurizing the bowl so as to flow the accumulated outer layer back through the bottom passageway and axially out of the bowl for collection in a reservoir and subsequent patient reinfusion.
- a rotatable centrifuge bowl assembly may be employed which includes a cylindrical outer bowl, a cylindrical internal spacer interconnected within the outer bowl for rotation therewith, and a stationary stator assembly for introducing fluid to and removing fluid from an annular, cylindrical collection region defined between the vertically straight, internal sidewall of the vertically straight, outer bowl and the outer sidewall of the internal spacer.
- annular, cylindrical collector region contains an annular fluid bed comprising inner and outer layers as noted above.
- the internal spacer and outer bowl are configured and interconnected so as to further define a substantially lateral, radiating passageway at the bottom of the centrifuge bowl assembly, and an annular upward facing port from such lateral passageway vertically into the cylindrical, annular collection region.
- the width of the annular port is less than the width of the annular, cylindrical collection region.
- the bottom external surface of the internal spacer is substantially flat while the opposing internal surface at the bottom of the outer bowl angles slightly upward and outward to define a narrowing, central portion of the lateral passageway.
- an internal spacer can be employed which includes an annular, continuous fin projecting outwardly from the outer sidewall of the spacer, most preferably at and completely about the bottom peripheral extreme thereof.
- Such fin may advantageously extend outward a predetermined distance from the circular sidewall of the internal spacer, wherein enhanced washing benefits can be realized during use (e.g. by providing for directed passage of wash solution towards and/or directly into accumulated red blood cells during filling/ washing steps) .
- a fin having an upward angulation of at least about 3 to 27 relative to horizontal is desirable, and even more desirably between about 3 and 7.
- a fin having a predetermined length i.e. outward extension relative to the outer sidewall surface of the internal spacer
- a fin length which exceeds about 20% of the width of the annular, cylindrical collection region
- the outer bowl and internal spacer can each be of a two-piece plastic construction.
- the internal spacer may comprise upper and lower members which are adjoined (e.g. with ultrasound welding) after separate molding (e.g., via injection- molding techniques) .
- the length and angulation of the above- noted lateral passageway and outwardly extending fin can be of significant importance, and therefore reliable molding of the lower member of the internal spacer is of particular interest.
- Figure 1 illustrates a cross-sectional view of one centrifuge bowl assembly embodiment of the present invention.
- Figure 2 is a cross-sectional assembly view of the internal spacer utilized in the embodiment of Fig. 1.
- Figs. 3A and 3B, and Figs. 3C and 3D illustrate various stages of fill and wash cycles within the centrifuge bowl assembly embodiment of Fig. 1.
- 1-3 comprises an outer bowl 20, internal spacer 40 interconnected within outer bowl 20 for driven rotation therewith about axis AA, and a stationary stator assembly 60 for introducing/ removing fluids to/from the assembly 10.
- the illustrated embodiment will be described in relation to an autologous blood salvage application, but it will be understood that the invention may have broader application .
- stator assembly 60 includes a fluid inlet tube 62 having a bottom end 64 positioned in bottom well region 32 for the sequential introduction of salvaged blood and wash solution and for removal of the harvested RBC product during use.
- the bottom well region 32 is fluidly interconnected to an outwardly, radiating passageway 34 defined between the internal, bottom surface 22 of the outer bowl 20 and the external, bottom surface 42 of internal spacer 40.
- the passageway 34 includes a narrowing, central portion 36 and peripheral portion 38. As illustrated, the central portion 36 narrows by virtue of the upward and outward sloping of the bottom surface 22 of outer bowl 20 at an angle of (e.g., about 3 ) relative to the horizontal bottom surface 42 of internal spacer 40.
- the passageway 34 terminates in an upwardly-oriented port 80 to permit salvaged blood and wash solution passage therethrough into a cylindrical, annular collection region 82 defined between the straight, inner surface of the straight, substantially vertical sidewall 24 of the outer bowl 20, and the straight, substantially vertical outer surface of sidewall 44 of the internal spacer 40.
- the width 1 of port 80 is less than the width t of the annular, collection region 82.
- the annular, collection region 82 is in fluid communication with fluid removal channels 66, included within the stator assembly 60, as will be further described.
- the stator assembly 60 provides for a rotating seal between stator assembly 60 and the outer bowl 20, e.g., as taught by U.S. Patent No. 4,684,361. As shown in Fig.
- the port 80 is defined between the substantially vertical, inner surface of side wall 24 and the outer bowl 20 and the peripheral edge of an annular fin 50 protruding at and about the bottom peripheral extreme of internal spacer 40.
- annular fin 50 may be configured so that a bottom surface 52 of annular fin 50 angles upwardly and outwardly at an angle of (e.g. about 3 to about 27 , and preferably about 3 to 7 ) relative to the horizontal, bottom surface 42 of internal spacer 40.
- internal spacer 40 may comprise injection-molded bottom section 46 having annular fin 50 integrally defined therewith, and injection-molded top section 48.
- the bottom section 46 and top section 48 may be assembled together via interfacing projections on bottom section 46 and 58 on top section 48, respectively, wherein the bottom and top sections 46 and 48 are secured by melting the interfacing projections 56 and 58 together via ultrasonic welding during assembly.
- an annular recess 47 may be defined in bottom member 46 upon molding. More particularly, the inclusion of recess 47 significantly reduces any distortion of fin 50 that may otherwise occur upon cooling after molding, wherein the angulation and overall profile of fin 52 is maintained substantially uniform about the circular periphery thereof.
- fin 50 is of a length f, wherein the ratio of fin 50 length f to annular collection region 82 width t is at least about .2, and even more preferably between about .25 to .60.
- fin 50 should have a length of between about .06" to .17".
- a fin 50 length of about .09", fin 50 thickness of about .06", and fin 50 surface 52 upward angulation of about 4 provides for excellent results .
- FIGs. 3A and 3B illustrate the successive passage of salvaged blood then wash solution into an annular collection region 82 of a rotating centrifuge bowl assembly 10, wherein red blood cells accumulate in an outer layer 90 in the annular collection region 82, and undesired blood components and wash solution accumulate and are removed from an inner layer 92 in the annular collection region 82.
- Fig. 3A illustrates introduction of salvaged blood 100 during a filling step.
- salvaged blood 100 passes through passageway 34 and into the annular collection region 82 via port 80.
- red blood cells are accumulated in an outer layer 90
- undesired blood components accumulate in an inner layer 92.
- Such undesired components may include, for example, an anticoagulent (e.g. heparin), white blood cells and platelets, plasma-free hemoglobin and activated/inactivated clotting factors .
- red blood cells will continue to accumulate in the outer layer 90 while the undesired components accumulate in the inner layer 92 and are removed through passageway 66 (not shown in Fig. 3A) .
- the outer layer 90 accumulates to a thickness sufficient to completely cover port 80.
- the density gradient across and thickness of the outer layer 90 is substantially constant along the vertical extent thereof.
- relatively high blood fill rates e.g. at least about 300 ml. /min., and most typically about 400 ml. /min., for 250 ml. bowl containment volume
- relatively high wash solution input rates e.g. at least about 500 ml. /min., and most typically about 800 ml. /min., for 250 ml. bowl containment volume
- Fig. 3A illustrates the inclusion of an optical sensor assembly 120 positioned adjacent to the top of outer bowl 20 for detecting when the outer layer 90 reaches a predetermined volume so as to automatically terminate the salvaged blood filling step and initiate the wash step.
- a predetermined volume may be advantageously selected to provide for outer layer 90 coverage of port 80.
- optical sensor assembly 120 may include an infrared light source and detector for emitting and detecting light having a predetermined center-wavelength that will generally be more readily absorbed by red blood cells than undesired components accumulating in layer 92. Therefore, since optical sensor assembly 120 is angled (e.g. at about 45 ), emitted light will pass through the clear bowl 20 and reflect off of the upper radius of spacer 40 (i.e.
- Fig. 3B illustrates a wash cycle during which a predetermined volume of wash solution 102 (e.g., 1000 ml. of saline solution for a 250 ml. bowl containment volume) is introduced through the passageway 34 and port 80 into the annular collection region 82. More particularly wash solution 102 is introduced directly into the bottom of outer layer 90.
- a predetermined volume of wash solution 102 e.g., 1000 ml. of saline solution for a 250 ml. bowl containment volume
- wash solution 102 is directed through vertical port 80 at an acute, upward angle relative to horizontal.
- wash solution 102 when coupled with the uniform packing of red blood cells within outer layer 90, allows an enhanced degree of washing to be realized by the present invention. That is, wash solution 102 will penetrate and mix into outer layer 90 so as to contact and wash undesired components from the red blood cells.
- enhanced washing is achieved in the present invention by virtue of the position and configuration of port 80 and fin 50 as well as the vertical configuration of the sidewalls 24 and 44 of bowl 20 and spacer 44, respectively.
- Fig. 3C illustrates a second filling step, wherein additional salvaged blood 100 is introduced through passageway 34 into collection region 82.
- the red blood cells continue to accumulate in the outer layer 90 while the undesired components accumulate in the inner layer 92 for removal through passageway 66 (not shown) .
- the outer layer 90 is now thick enough to completely cover port 80.
- Fig. 3D shows a second washing step, wherein wash solution 102 is introduced directly into the bottom of outer layer 90.
- wash solution 102 when coupled with the uniform packing of red blood cells within outer layer 90, allows an enhanced degree of washing to be realized.
- the wash solution 102 is able to move through and contact a significant portion of the RBCs within outer layer 90. It should be noted that when there is significant hemolysis in the salvaged blood, a relatively large amount of plasma-free hemoglobin may accumulate during filling with the red blood cells in the outer layer 90 and thereby trigger detection by optical sensor assembly 120. Should this occur in use of the present invention, the wash cycle illustrated in Fig.
- the accumulated outer layer 90 comprising the red blood cells may recede to a volume less than the predetermined desired volume that triggered termination of the initial filling step and initiation of the initial wash step.
- the sensor assembly 120 may be provided so as to detect such condition, wherein a second filling step can be automatically initiated and carried out as shown in Fig. 3D.
- Such second filling step may be terminated in the same manner as described above in relation to Figs. 3A and 3B . Iterative fill and wash steps may continue until the desired predetermined volume of the outer layer 90 comprising red blood cells is achieved.
- the outer layer may be emptied from bowl 20 via tube 62.
- rotation of bowl 20 may be terminated and bowl 20 may be pressurized so as to cause the accumulated RBC-containing product to flow through port 80, passageway 34 and out of the bowl via tube 62.
- the harvested product may then be collected in a reservoir for subsequent patient reinfusion.
- an improved RBC blood product can be attained.
- mass anticoagulant removal of at least about 98% can be realized. That is, for example, where the blood introduced for processing comprises a given number of units of anticoagulent (e.g. heparin), at least about 98% of the mass of such anticoagulent may be removed via washing, wherein the final, outer layer of RBC-containing product includes less than about 2% of the mass of the anticoagulant.
- the enhanced washing can be obtained while maintaining blood fill rates into bowl 20 of at least about 300 ml. /min. and more typically about 400 ml. /min., and wash solution inlet rates of at least about 500 ml. /min. at more typically about 800 ml. /min.
- the resultant RBC product can be provided with a hematocrit of above about 42%, and more typically of at least about 50%.
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AT98934406T ATE211659T1 (en) | 1997-07-11 | 1998-07-10 | CENTRIFUGE ROTOR FOR AUTOLOGOUS BLOOD COLLECTION |
EP98934406A EP0925116B1 (en) | 1997-07-11 | 1998-07-10 | Centrifuge bowl for autologous blood salvage |
AU83930/98A AU8393098A (en) | 1997-07-11 | 1998-07-10 | Centrifuge bowl for autologous blood salvage |
CA002265517A CA2265517A1 (en) | 1997-07-11 | 1998-07-10 | Centrifuge bowl for autologous blood salvage |
JP50897099A JP2002511011A (en) | 1997-07-11 | 1998-07-10 | Centrifugal bowl device for autologous blood collection |
DE69803434T DE69803434T2 (en) | 1997-07-11 | 1998-07-10 | CENTRIFUGAL ROTOR FOR AUTOLOGOUS BLOOD COLLECTION |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/891,471 US5919125A (en) | 1997-07-11 | 1997-07-11 | Centrifuge bowl for autologous blood salvage |
US08/891,471 | 1997-07-11 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999002269A1 true WO1999002269A1 (en) | 1999-01-21 |
Family
ID=25398252
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/014345 WO1999002269A1 (en) | 1997-07-11 | 1998-07-10 | Centrifuge bowl for autologous blood salvage |
Country Status (8)
Country | Link |
---|---|
US (1) | US5919125A (en) |
EP (1) | EP0925116B1 (en) |
JP (1) | JP2002511011A (en) |
AT (1) | ATE211659T1 (en) |
AU (1) | AU8393098A (en) |
CA (1) | CA2265517A1 (en) |
DE (1) | DE69803434T2 (en) |
WO (1) | WO1999002269A1 (en) |
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US9238097B2 (en) | 2002-03-04 | 2016-01-19 | Therakos, Inc. | Method for collecting a desired blood component and performing a photopheresis treatment |
US9415021B2 (en) | 2009-08-25 | 2016-08-16 | Nanoshell Company, Llc | Synthesis of oxygen carrying, turbulence resistant, high density submicron particulates |
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- 1998-07-10 JP JP50897099A patent/JP2002511011A/en not_active Ceased
- 1998-07-10 AU AU83930/98A patent/AU8393098A/en not_active Abandoned
- 1998-07-10 CA CA002265517A patent/CA2265517A1/en not_active Abandoned
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- 1998-07-10 EP EP98934406A patent/EP0925116B1/en not_active Expired - Lifetime
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Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
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EP1075844A2 (en) | 1999-08-12 | 2001-02-14 | Fresenius AG | Device and method for autologous blood transfusion |
DE19938287A1 (en) * | 1999-08-12 | 2001-03-15 | Fresenius Ag | Device and method for autologous transfusion of blood |
US6964646B1 (en) | 1999-08-12 | 2005-11-15 | Fresenius Hemocare Gmbh | Device and method for autologous blood transfusion |
US10556055B2 (en) | 2002-03-04 | 2020-02-11 | Mallinckrodt Hospital Products IP Limited | Method for collecting a desired blood component and performing a photopheresis treatment |
US9238097B2 (en) | 2002-03-04 | 2016-01-19 | Therakos, Inc. | Method for collecting a desired blood component and performing a photopheresis treatment |
US7914477B2 (en) | 2002-03-04 | 2011-03-29 | Therakos, Inc. | Apparatus for the continuous separation of biological fluids into components and method of using same |
EP2285464A4 (en) * | 2008-04-22 | 2014-01-01 | Pneumatic Scale Corp | Single use centrifuge system |
US9415021B2 (en) | 2009-08-25 | 2016-08-16 | Nanoshell Company, Llc | Synthesis of oxygen carrying, turbulence resistant, high density submicron particulates |
US9956180B2 (en) | 2009-08-25 | 2018-05-01 | Nanoshell Company, Llc | Method and apparatus for continuous removal of sub-micron sized particles in a closed loop liquid flow system |
US10099227B2 (en) | 2009-08-25 | 2018-10-16 | Nanoshell Company, Llc | Method and apparatus for continuous removal of sub-micron sized particles in a closed loop liquid flow system |
US10675641B2 (en) | 2009-08-25 | 2020-06-09 | Nanoshell Company, Llc | Method and apparatus for continuous removal of sub-micron sized particles in a closed loop liquid flow system |
US10751464B2 (en) | 2009-08-25 | 2020-08-25 | Nanoshell Company, Llc | Therapeutic retrieval of targets in biological fluids |
US11285494B2 (en) | 2009-08-25 | 2022-03-29 | Nanoshell Company, Llc | Method and apparatus for continuous removal of sub-micron sized particles in a closed loop liquid flow system |
US20210205734A1 (en) * | 2019-06-06 | 2021-07-08 | Pneumatic Scale Corporation | Centrifuge System for Separating Cells in Suspension |
US11957998B2 (en) * | 2019-06-06 | 2024-04-16 | Pneumatic Scale Corporation | Centrifuge system for separating cells in suspension |
Also Published As
Publication number | Publication date |
---|---|
DE69803434D1 (en) | 2002-02-28 |
EP0925116B1 (en) | 2002-01-09 |
EP0925116A1 (en) | 1999-06-30 |
DE69803434T2 (en) | 2002-11-07 |
AU8393098A (en) | 1999-02-08 |
JP2002511011A (en) | 2002-04-09 |
US5919125A (en) | 1999-07-06 |
CA2265517A1 (en) | 1999-01-21 |
ATE211659T1 (en) | 2002-01-15 |
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