CA2429369A1 - Apparatus and method for in-vivo plasmapheresis using periodic backflush - Google Patents

Apparatus and method for in-vivo plasmapheresis using periodic backflush Download PDF

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Publication number
CA2429369A1
CA2429369A1 CA002429369A CA2429369A CA2429369A1 CA 2429369 A1 CA2429369 A1 CA 2429369A1 CA 002429369 A CA002429369 A CA 002429369A CA 2429369 A CA2429369 A CA 2429369A CA 2429369 A1 CA2429369 A1 CA 2429369A1
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CA
Canada
Prior art keywords
lumen
fluid
plasma
fibers
backflush
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002429369A
Other languages
French (fr)
Other versions
CA2429369C (en
Inventor
Reynolds G. Gorsuch
Tommy Cooper
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Transvivo Inc
Original Assignee
Transvivo, Inc.
Reynolds G. Gorsuch
Tommy Cooper
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Filing date
Publication date
Application filed by Transvivo, Inc., Reynolds G. Gorsuch, Tommy Cooper filed Critical Transvivo, Inc.
Publication of CA2429369A1 publication Critical patent/CA2429369A1/en
Application granted granted Critical
Publication of CA2429369C publication Critical patent/CA2429369C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1678—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes intracorporal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/1682—Sterilisation or cleaning before or after use both machine and membrane module, i.e. also the module blood side
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/1688—Sterilisation or cleaning before or after use with recirculation of the sterilising fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3413—Diafiltration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7554—General characteristics of the apparatus with filters with means for unclogging or regenerating filters

Abstract

Apparatus and method for in-vivo plasmapheresis utilizing a plurality of elongated hollow microporous filter fibers periodically interrupt diffusion of blood plasma from a patient, and, for a selected time, backflush fluid into the fibers at a pressure and interval sufficient to cleanse the fiber pores, after which plasma diffusion is resumed.

Claims (36)

1. Apparatus for carrying out in-vivo plasmapheresis comprising:
a filter for being planted in a patient's blood vessel comprising a plurality of elongated hollow microporous fibers having an interior lumen and a fiber wall having a pore size capable of allowing plasma to diffuse therethrough;
a multiple lumen catheter in fluid communication with the interior fiber lumen including a first lumen for directing backflush fluid into said fiber lumen and a second lumen for directing plasma from said fiber lumen; and one or more pumps for pumping backflush fluid into said fiber lumen at a pressure and duration sufficient to backflush and cleanse the pores of the fiber walls.
2. Apparatus of Claim 1 wherein one of said pumps is in fluid communication with said first lumen for pumping backflush fluid therethrough.
3. Apparatus of Claim 2 including a source of backflush fluid in fluid communication with said pump and said first lumen.
4. Apparatus of Claim 2 including a microprocessor/controller operatively connected to one or more pumps.
5. Apparatus of Claim 4 wherein said microprocessor/controller and said one or more pumps cooperate to direct said backflush fluid into said microporous membrane fibers for a duration and at a flow rate sufficient to backflush and substantially cleanse the membrane pores.
6. Apparatus of Claim 5 wherein said microprocessor/controller and said one or more pumps cooperate to direct said backflush fluid into said microporous membrane fibers at a pressure sufficient to substantially cleanse the membrane pores.
7. Apparatus of Claim 1 comprising a first pump in fluid communication with said first lumen and a second pump in fluid communication with said second lumen for pumping plasma from said filter to plasma treatment apparatus.
8. Apparatus of Claim 7 including a third pump in fluid communication with a lumen for pumping plasma from plasma treatment apparatus to the blood vessel.
9. Apparatus of Claim 8 including a microprocessor/controller operatively connected to said first, second and third pumps.
10. Apparatus of Claim 9 wherein said microprocessor/controller and said pump cooperate to direct said backflush fluid into said microporous membrane fibers for a duration and at a flow rate sufficient to backflush and substantially cleanse the membrane pores.
11. Apparatus of Claim 10 wherein said microprocessor/controller and said pump cooperate to direct said backflush fluid into said microporous membrane fibers at a pressure sufficient to substantially cleanse the membrane pores.
12. Apparatus of Claim 7, 8, 9 or 10 including a pump and conduit cooperating therewith for pumping separated plasma components from plasma treatment apparatus to a container.
13. Apparatus of Claim 1 wherein said one or more pumps is capable of pumping the backflush fluid at a pressure of between about 15 and about 100 mg Hg for a duration of between about 5 and about 50 seconds.
14. Apparatus of Claim 1 wherein said one or more pumps is capable of pumping said backflush fluid at a rate of between about 5 and about 45 ml/minute.
15. Apparatus of Claim 1 wherein said fibers have a sieving coefficient cutoff of between 2×104 and 4×108 Daltons.
16. Apparatus of Claim 1 wherein said fibers comprise a fiber wall having a plurality of zones between the inner and outer wall surfaces, each of said zones having a mass density different than the mass density of an adjacent zone, said fiber wall characterized by having a lower mass density zone at the inner wall surface and a higher mass density zone at the outer wall surface.
17. Apparatus of Claim 16 wherein said fiber wall has two mass density zones.
18. Apparatus of Claim 16 wherein said fiber wall has three mass density zones.
19. Apparatus of Claim 16 wherein said fiber wall has four or more mass density zones.
20. Apparatus of Claim 17, 18 or 19 wherein each of said zones is characterized by a different average nominal pore size.
21. Apparatus of Claim 20 capable of in-vivo plasmapheresis wherein said lower mass density zone is characterized by a nominal average pore diameter of between about 1 µm and about 60 µm.
22. Apparatus of Claim 20 wherein said higher mass density zone is characterized by a nominal average pare diameter of between about 0.3 µm and about 1 Vim.
23. Apparatus of Claim 21 wherein said higher mass density zone is characterized by a nominal average pore diameter of between about 0.3 µm and about 1 µm.
24. Apparatus of Claim 16 characterized by having the capability of extracting at least 0.75 (ml/min)(cm2×mm Hg) of blood plasma at traps-membrane pressures of between about 5 and about 20 mm Hg.
25. Apparatus of Claim 1 comprising one or more first pumps cooperating with said first lumen for pumping said backflush fluid therethrough, and wherein said apparatus includes one or more second pumps cooperating with said second lumen for pumping plasma from said fibers therethrough.
26. Apparatus of Claim 25 including one or more third pumps cooperating with said third lumen for pumping plasma therethrough.
27. Apparatus of Claim 26 including plasma treatment apparatus for removing toxins from the plasma diffused through the fibers.
28. Apparatus of Claim 27 including a pump and conduit cooperating therewith for pumping separated plasma components from plasma treatment apparatus to a container.
29. A method of carrying out in-vivo plasmapheresis comprising:
implanting a fitter device within a blood vessel of a patient, said filter device comprising a plurality of elongated hollow microporous fibers;
providing a multiple lumen catheter in fluid communication with the hollow interior of said fibers;
and diffusing plasma and toxins from the patient's blood through the wall of said fibers into the hollow interior thereof, and therefrom through a second lumen of said catheter;
interrupting said diffusion of plasma and toxins and thereafter directing a fluid through a first lumen of said catheter into said fibers and backflushing said fibers with said fluid at a pressure and for an interval sufficient to substantially cleanse the pores of said filter, and after said interval, resuming said diffusion of plasma.
30. A method of Claim 29 wherein the fluid is backflushed at a pressure of between about 15 and about 100 mg Hg for an interval of between about 5 and about 50 seconds.
31. A method of Claim 29 or 30 wherein said backflush fluid comprises saline solution.
32. A method of Claim 29 or 30 wherein said fluid is backflushed by pumping said fluid into the hollow interior of said fibers.
33. A method of Claim 32 wherein said fluid is pumped into said fibers at a pressure of between about 15 and about 100 mg Hg.
34. A method of Claim 32 or 33 wherein said fluid is pumped into said fiber for an interval of between about 5 and about 50 seconds.
35. A method of Claim 29 including a plasma treatment apparatus, and wherein toxin-containing plasma from said fibers is directed to said plasma treatment apparatus through said second lumen of said catheter.
36. A method of Claim 35 wherein plasma from said plasma treatment apparatus is directed to a third lumen of said catheter and returned to said patient.
CA002429369A 2001-01-04 2001-12-20 Apparatus and method for in-vivo plasmapheresis using periodic backflush Expired - Fee Related CA2429369C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/754,773 2001-01-04
US09/754,773 US6659973B2 (en) 2001-01-04 2001-01-04 Apparatus and method for in-vivo plasmapheresis using periodic backflush
PCT/US2001/050431 WO2002053210A2 (en) 2001-01-04 2001-12-20 Apparatus and method for in-vivo plasmapheresis using periodic backflush

Publications (2)

Publication Number Publication Date
CA2429369A1 true CA2429369A1 (en) 2002-07-11
CA2429369C CA2429369C (en) 2009-11-17

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CA002429369A Expired - Fee Related CA2429369C (en) 2001-01-04 2001-12-20 Apparatus and method for in-vivo plasmapheresis using periodic backflush

Country Status (10)

Country Link
US (3) US6659973B2 (en)
EP (1) EP1351725B1 (en)
JP (1) JP4012069B2 (en)
AT (1) ATE362779T1 (en)
AU (1) AU2002231285B2 (en)
CA (1) CA2429369C (en)
DE (1) DE60128586T2 (en)
ES (1) ES2287182T3 (en)
IL (1) IL155948A0 (en)
WO (1) WO2002053210A2 (en)

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Also Published As

Publication number Publication date
DE60128586D1 (en) 2007-07-05
EP1351725B1 (en) 2007-05-23
ES2287182T3 (en) 2007-12-16
JP2004516893A (en) 2004-06-10
AU2002231285B2 (en) 2006-10-26
IL155948A0 (en) 2003-12-23
DE60128586T2 (en) 2008-01-31
US20090118660A1 (en) 2009-05-07
WO2002053210A2 (en) 2002-07-11
US20030236482A1 (en) 2003-12-25
EP1351725A2 (en) 2003-10-15
WO2002053210A3 (en) 2003-02-13
US8070706B2 (en) 2011-12-06
CA2429369C (en) 2009-11-17
ATE362779T1 (en) 2007-06-15
US20020087109A1 (en) 2002-07-04
US6659973B2 (en) 2003-12-09
JP4012069B2 (en) 2007-11-21

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