Cross-spike prevention system

• US 5,439,460 A
• Filed: 09/07/1993
• Issued: 08/08/1995
• Est. Priority Date: 09/07/1993
• Status: Expired due to Fees

• Current Assignee: Bryan J. Hoover
• Original Assignee: Bryan J. Hoover
• Inventors: Hoover, Bryan J.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): ZUTTARELLI, ANTHONY
• Application Number:
  US08/117,729
• Time in Patent Office: 700 Days
• Field of Search: 604/403, 604/404, 604/408, 604/409, 604/322, 604/326, 604/4-6, 604/131-133, 604/174, 604/175, 604/176, 604/177, 604/178, 604/905, 128/912, 128/DIG. 6, 128/DIG. 12, 128/DIG. 13, 128/DIG. 24, 128/DIG. 26, 222/55, 222/93, 222/94, 222/97, 222/105
• US Class Current: 604/403
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: Y10S 128/13 Infusion monitoring
• CPC Class Codes: Y10S 128/24 Medical-surgical bags
• CPC Class Codes: Y10S 128/26 Cannula supporters
• CPC Class Codes: Y10S 128/912 Connections and closures for tubes delivering fluids to or from the body
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

An improved device and process of assuring separation of an anticoagulant type fluid from a saline type fluid each of which is utilized in the process and operation of a plasmapheresis apparatus or the process of collecting donor blood, is disclosed. The improvement includes a cross-spike prevention receptacle which is dimensioned, and installed positionally in reference to a plasmapheresis or blood donor apparatus, to receive an anticoagulant fluid container to which a proper respective supply communication line will connect, and to exclude and not receive a saline fluid container or container holding a similiar type of fluid, whose fluid line will not reach and connect to the installed cross-spike prevention receptacle. As a part of the process and concepts of the invention the supply containers or bags of fluids which are supplied for use with the invention are provided so that the respective anticoagulant bags are smaller in volume capacity and size than the respective saline solution container bags used in the plasmapheresis or blood collection process, and the bags are dimensioned so that the saline container or bag will not fit into the cross-spike prevention receptacle even upon substantial forcing or where such force would cause rupture of the container or would otherwise result in a container in a condition which could not be reasonably used with respect to the plasmapheresis or blood collection process.

Claims

1. An improved means of assuring separation of respective process and replacement fluids utilized in the operation of a blood plasma collection apparatus, which utilizes, at least, a first fluid bag and a second fluid bag differentially connected thereto, to directly supply a plasmapheresis fluid and a replacement fluid, respectively, the improvement comprising:

a cross-spike prevention receptacle defining a hollow opening dimensioned such that it will receive the first fluid bag and exclude the second fluid bag;

said receptacle being differentially positioned adjacent to the blood plasma collection apparatus, such that the the first fluid bag connected to the collection apparatus will extend to and fit into the receptacle, and the second fluid bag connected to the apparatus will not extend to and fit into the receptacle;

the first fluid bag being provided in a substantially smaller volume and spatial size than that of the second fluid bag.

2. The cross-spike prevention receptacle of claim 1,

wherein:

the receptacle has a cylindrically oriented configuration, and further comprises means for coupling and attaching to the blood collection apparatus; and

wherein;

the plasmapheresis process fluid supplied by the first fluid bag is an anticoagulent fluid, and the replacement fluid supplied by the second fluid bag is a saline solution.

3. The cross-spike prevention receptacle of claim 2,

wherein:

the receptacle further comprises means for guiding a fluid communication line leading from the collection apparatus to the first fluid bag, toward and adjacent to the receptacle.

4. The cross-spike prevention receptacle of claim 1, wherein:

the receptacle has a rectangularly oriented configuration, and further comprises means for attaching the receptacle to the blood collection apparatus.

5. The cross-spike prevention receptacle of claim 4,

wherein:

the receptacle further comprises means for guiding a fluid communication line leading from the collection apparatus to the first fluid bag, toward and adjacent to the receptacle.

6. The cross-spike prevention receptacle of claim 1,

wherein:

the receptacle has a square-like configuration where one of its front and back sides have substantially different lengths, and said receptacle further comprises means for coupling the receptacle to the blood collection apparatus; and

means for guiding a fluid communication tube leading from the collection apparatus to the first fluid bag, adjacent to the receptacle.

7. An improved means of assuring separation of an anticoagulent fluid from a saline fluid utilized, and requiring respective segregation, in a process and operation of a plasmapheresis apparatus, having respective fluid lines differentially attached thereto for communicating and transporting the respective fluids from a respective supply container to the apparatus, each of which is respectively connected thereto;

comprising;

a cross-spike prevention receptacle, constructed of a partially to substantially transparent, moldably resilient material;

dimensioned, and installed positionally, in differential relationship to the respective fluid lines of the plasmapheresis apparatus, such that the receptacle will receive the anticoagulent supply container to which the attached respective fluid line from the apparatus for transporting anticoagulent fluid will connect, and such that the receptacle will not, as then positioned, receive the saline fluid container, to which the respective fluid line from the apparatus for transporting saline fluid will not connect;

wherein the supply containers of fluids are provided such that the respective anticoagulent supply container is smaller in volume capacity than the respective saline supply container.

8. The cross-spike prevention receptacle of claim 7, wherein:

said receptacle is a container assembly, comprising;

a cylindrical subassembly having a circumferential wall defining first and second open ends, at opposite ends of its length, in communication with one another,

said circumferential wall further defining a first slotted area having perimeters parallel to one another and extending the length of the wall, from said first end to said second end, and

a slotted bag support member having a perimeter substantially conterminous with the dimensions of said second end of said circumferential wall and being fixedly attached thereto, said support member defining a U-shaped slot with the top end portions of the slot being substantially in communication with the parallel perimeters of the slotted area of said circumferential wall; and

a mount base subassembly being substantially rectangular in configuration, and having first and second spaced surfaces, first and second parallel side surfaces and top and bottom ends,

said first spaced surface defining a concavity in dimensions substantially conterminous with the convexity of the circumferential wall of said cylindrical subassembly, and being fixedly attached to said wall such that the slotted area of the wall faces substantially in the same direction as the plane generated by the first parallel side surface,

said second spaced surface having means for fixedly attaching the surface to a plasmapheresis apparatus,

said mount base subassembly further comprising means for guiding an anticoagulant conveying tube from a plasmapheresis apparatus to the slotted bag support member,

said means being detachably mounted on said first parallel side surface and on a portion of the side of a plasmapheresis apparatus;

whereby said container assembly can be installed on the left bottom side of a plasmapheresis apparatus, with the slotted area of said wall facing substantially in the same direction as the front of an apparatus, and receive a guided anticoagulant conveying tube through the slotted bag support member to attach to an installed bag of anticoagulant fluid.

9. The cross-spike prevention receptacle of claim 7, wherein:

said receptacle is a slotted, rectangularly shaped container assembly having first and second ends, first and second parallel spaced surfaces and first and second parallel side surfaces,

said first end defining an opening along the perimeters of the container in communication with said second end,

said first parallel spaced surface defining a slotted area with perimeters along the length of said first surface substantially parallel to one another,

said second end defining a U-shaped slot whose upper ends are substantially conterminous with the perimeters of the slotted area of said first parallel spaced surface,

said rectangular container assembly further comprising;

a rectangular mount base support member,

said mount base being fixedly attached at one of its surfaces to the first parallel side surface,

and having means for guiding an anticoagulant communication tube to the U-shaped slot of said second end, and

means for fixedly attaching the base to a plasmapheresis apparatus.

10. The cross-spike prevention receptacle of claim 7, wherein:

said receptacle is a rectangular reservoir, defining a hollow cavity, and having first and second ends, front and back parallel spaced surfaces, said front surface being shorter in length than said back surface, and first and second parallel side surfaces.

11. In combination with a blood plasma collection apparatus having a first fluid supply line with a supply insertion tip at one of its ends, and installed at its other end to the apparatus such that the first line is oriented toward the bottom portion of the blood apparatus, and a second fluid supply line with a supply insertion tip at one of its ends, and installed at its other end to the apparatus such that the second line is oriented toward the top portion of the apparatus, said first line being dimensioned and positioned such that the insertion tip thereof will operationally extend to the bottom portion and will not so extend to the top portion of the apparatus, and said second line being dimensioned and positioned such that the insertion tip thereof will operationally extend to the top portion and will not so extend to the bottom portion of the apparatus;

a cross-spike prevention assembly, comprising;

a first fluid supply container and a second fluid supply container, the second container being dimensioned, defining, and providing for, a volume for supply fluid, and said first container being dimensioned, defining, and providing for, a volume for supply fluid, substantially smaller in volume than that of said second fluid supply container, and

a receptacle so dimensioned, such that said first supply container will operationally slide into and be supported by the receptacle and the second supply container will not operationally slide into and be supported by said receptacle;

said receptacle being positioned on the apparatus, oriented to the bottom portion of the apparatus, and fixedly coupled thereat, and said first fluid supply container being slideably installed into said receptacle for operational support therein;

said first fluid supply line being coupled to said first fluid container by insertion of the insertion tip of the first line into the installed container; and

the second supply container being independently supported, segregated from the installed receptacle, adjacent to the top portion of the apparatus, for use thereat,

said second fluid supply line being coupled to the second container by insertion of the insertion tip of the second line into the segregated and independently supported second container.

12. The combination of claim 11, wherein:

the volume for supply fluid of the first fluid supply container is provided with an anticoagulent fluid, and

the volume for supply fluid of the second fluid supply container is provided with a saline solution;

each of the supply fluids being utilized by the apparatus in a blood plasma collection or plasmapheresis process.

13. The combination of claim 12, wherein:

the ratio of volumes for supply fluid, the volume of the first container to the volume of the second container, respectively, is substantially defined by a ratio of about 1;

2, respectively.

14. In combination with that part of a plasmapheresis process apparatus for blood plasma collection that is required for donor safety to function to segregate an anticoagulent fluid from a replacement saline solution, such that anticoagulent fluid is not mistakenly provided by the apparatus to a plasma donor in place of replacement saline solution during the plasma collection process;

a cross-spike prevention assembly, comprising at least first, second, third and fourth differential subassemblies;

said first differential subassembly comprising first and second fluid supply lines, each having first and second ends, said first line being coupled at one end thereof to the apparatus at a lower portion thereof and having an insertion tip at the other end, the line being differentially dimensioned to interface only with the lower portion, and said second line being coupled at one end thereof to the apparatus at an upper portion thereof, and having an insertion tip at the other end, the line being differentially dimensioned to interface only with the upper portion;

said first supply line being interfaced with the plasmapheresis process apparatus to provide an anticoagulent fluid to the apparatus during the whole blood collection and plasma component separation by the apparatus, and said second supply line being interfaced with the apparatus to provide a saline solution to the apparatus as a replacement fluid to be returned to a donor by the apparatus;

said second differential subassembly comprising first and second pressable and variable configurational, fluid supply bags, said first supply bag having an outer perimeter defining and enclosing a first volume, and the second supply bag having an outer perimeter defining and enclosing a second volume, said first volume being about one-half smaller than the second volume, said first bag containing within its volume and supplying therefrom anticoagulent fluid and the second bag containing and supplying saline solution,

said third differential subassembly comprises a receptacle differentially dimensioned to receive said first fluid supply bag in an operational configuration for supplying fluid therefrom, and exclude and not receive the second fluid supply bag in an operational configuration for supplying fluid therefrom, and

said fourth differential subassembly comprises attachment and guide means for fixedly and differentially positioning said receptacle on the apparatus and guiding the first supply line such that the receptacle and line are, each, oriented and adjacent to the lower portion of the apparatus for installation of the first supply bag and coupling with the first supply line, and for supportably positioning the second supply bag adjacent to the upper portion of the apparatus for coupling with the second supply line;

said first bag being installed in the positioned receptacle, and coupled with said first supply line, and said second bag as supportably positioned being coupled with the second supply line, each, for operation with the apparatus, in collecting and preserving a plasma blood component from a donor, and communicating a replacement saline solution to the donor during the plasmapheresis process, respectively.

15. The combination of claim 14,

wherein:

said attachment and guide means of said fourth differential subassembly guides the first supply line such that the line at a substantial portion of its coupled end thereof, is oriented along an existing imaginary common plane adjacent to the apparatus, such that it substantially forms a first parabolic curve opening in a substantially negative y-direction on an existing imaginary polar coordinate axis,

and guides the second supply line such that the line, at a substantial portion of its coupled end thereof, is oriented along an existing imaginary common plane adjacent to the apparatus, such that it substantially forms a second parabolic curve opening in a substantially positive y-direction on an existing imaginary polar coordinate axis,

wherein the first parabolic curve of the first supply line substantially relates in positional orientation to an existing imaginary tangent line defined by the equation;

space="preserve" listing-type="equation">y=-2/3x+b,

where b is a negative unit-value defining a y-axis intercept on an existing imaginary polar coordinate having an x-axis along a plane adjacent to the apparatus and substantially dividing the surface thereof into an upper-positive portion and a lower-negative portion, and

the second parabolic curve of the second supply line substantially relates in positional orientation to an existing imaginary tangent line defined by the equation;

space="preserve" listing-type="equation">y=-2/3x+b,

where b is a positive unit-value defining a y-axis intercept on an existing imaginary polar coordinate having an x-axis along a plane adjacent to the apparatus and substantially dividing the surface thereof into an upper-positive portion and a lower-negative portion.