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WO1996009843A1 - Traitement thermique destine a l'inactivation virale - Google Patents

Traitement thermique destine a l'inactivation virale Download PDF

Info

Publication number
WO1996009843A1
WO1996009843A1 PCT/US1995/012097 US9512097W WO9609843A1 WO 1996009843 A1 WO1996009843 A1 WO 1996009843A1 US 9512097 W US9512097 W US 9512097W WO 9609843 A1 WO9609843 A1 WO 9609843A1
Authority
WO
WIPO (PCT)
Prior art keywords
coil
temperature
blood product
tubing
producing
Prior art date
Application number
PCT/US1995/012097
Other languages
English (en)
Inventor
Kenneth L. Carr
Original Assignee
Microwave Medical Systems, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Microwave Medical Systems, Inc. filed Critical Microwave Medical Systems, Inc.
Priority to AU36388/95A priority Critical patent/AU3638895A/en
Publication of WO1996009843A1 publication Critical patent/WO1996009843A1/fr

Links

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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/369—Temperature treatment
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3606—General characteristics of the apparatus related to heating or cooling cooled
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/366—General characteristics of the apparatus related to heating or cooling by liquid heat exchangers
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/368—General characteristics of the apparatus related to heating or cooling by electromagnetic radiation, e.g. IR waves
    • A61M2205/3686—General characteristics of the apparatus related to heating or cooling by electromagnetic radiation, e.g. IR waves microwaves

Definitions

  • This invention relates to the inactivation of viruses in blood products. It relates more particularly to a method and apparatus for inactivating viruses in blood products through the use of high temperature short time heating (HTST) of those products.
  • HTST high temperature short time heating
  • the prior HTST systems including the one described in the above paper, are disadvantaged in that they are basically batch systems. Some take a relatively long time to reach the process temperature; some require a relatively 0 long hold up time at the process temperature and some take a relatively long time to cool the process fluid to a non ⁇ destructive temperature.
  • one HTST system of which we are aware marketed by Alfa Laval under the name Sterimedia Mini and referred to in the above paper has a hold time of 5 about 2 to 4 seconds or more and a hold up volume of 1.5 liters, making it necessary to waste a large volume of product during processing.
  • this invention aims to provide an improved method of inactivating viruses in blood products while maintaining cellular function.
  • Another object of the invention is to provide a method of inactivating viruses in blood products by high-temperature short-time heating of the blood products on a continuous in ⁇ line basis.
  • a further object of the invention is to provide an HTST heating method which overcomes limitations of the prior processes by delivering microwave heating to a well defined in ⁇ line flowing pathway of a blood product in a rapid, uniform and controlled manner.
  • Still another object of the invention is to provide a unique HTST heating technique that allows exposure of blood products to uniform microwave heating energy for the purpose of virus deactivation as the contaminated fluid flows in-line through a microwave heating chamber and then through a cooling chamber.
  • Yet another object of the invention is to provide a high- temperature short-time microwave heating method which permits the shaping of the heating time and temperature parameters to provide heat destruction of virus activity while maintaining the functional constituency of the otherwise heat-sensitive blood products.
  • a further object of the invention is to provide apparatus for heat treating blood products to achieve viral inactivation and having one or more of the above advantages.
  • the invention accordingly comprises the several steps and the relation of one or more of such steps with respect to each of the others, and the apparatus embodying the features of construction, combination of elements and arrangement of parts which are adapted to effect such steps all as exemplified in the following detailed description, and the scope of the invention will be indicated in the claims.
  • our HTST system for achieving viral inactivation in blood products is an in-line system that processes the blood products on a continuous basis and in a rapid, uniform and closely controlled manner.
  • a blood product e.g., whole blood, plasma, etc. is flowed through a series of at least two, and preferably three, coils, each of which has a small priming volume, e.g., 4-5ml.
  • the first coil is situated in a microwave heating chamber, the second coil reposes in a cooling chamber and the third coil (if present) is positioned in a second microwave heating chamber that may be similar to the first such chamber.
  • the blood product is exposed to uniform microwave energy present in the first chamber which heats the product to a temperature sufficient to deactivate any viruses present in the product.
  • the heated product then flow through the second coil in the cooling chamber where it is immediately cooled to a lower delivery temperature.
  • the temperature profile along the product heating/cooling pathway is obtained and used to control the heating chamber to maintain a uniform product delivery temperature despite variations of fluid parameters such as flow rate and inlet temperature.
  • the product heating time and temperature parameters may be controlled carefully to allow complete destruction of virus activity in the blood product while maintaining the viability of the product.
  • the coils are provided as single use disposable cartridges with conventional connectors at opposite ends of the tubing runs to enable the cartridges to be connected together and to the blood product source and destination.
  • the two or three coils may be formed together as a single cartridge unit.
  • the source and destination may be standard blood bags when processing stored blood products or cannulae if a patient's blood is being processed extracorporally in a manner similar to dialysis.
  • the cartridges are designed to plug into receptacles in the heating and cooling chambers so that they are automatically positioned at the proper locations in those chambers as described in commonly owned Patent 5,073,167 and pending application Serial No. 08/142,577, the contents of which are hereby incorporated by reference herein.
  • a continuously moving column of a blood product from a patient or other source is rapidly heated in a microwave heating chamber to a temperature high enough to provide heat destruction of virus activity in the product and then the moving liquid is immediately cooled in an in-line cooling chamber to a non ⁇ destructive delivery temperature, e.g., body temperature (about 37 ⁇ C).
  • a non ⁇ destructive delivery temperature e.g., body temperature (about 37 ⁇ C).
  • the liquid product is cooled in the cooling chamber below the selected delivery temperature and then routed to another in-line microwave heating chamber which heats the product precisely to the desired delivery temperature. In this way, the delivery temperature is approached from below for optimum accuracy.
  • the blood product is flowed through the successive chambers through IV tubing whose I.D. is preferably quite small, e.g. .096in., with respect to the wavelength of the microwave heating frequency thereby ensuring uniform heating of the liquid which is in constant motion through the tubing.
  • the tubing is formed as a cartridge unit with a series of two (or three) coils which may be positioned in the two (or three) chambers present in the apparatus.
  • means are provided for monitoring the temperature of the moving liquid as it enters and leaves the various chambers utilizing non-invasive radiometry with detection occurring at microwave frequencies. This enables noninvasive measurements at depth to occur while the liquid is in motion through the tubing.
  • the measured differential temperatures are then used to determine the power level required for heating in the first (and, if present, the second) heating chamber.
  • a time/temperature profile may be produced in the moving column of blood product to provide maximum heat destruction of virus activity while maintaining the functional constituency of the blood product and product delivery at the proper delivery temperature.
  • the blood product is flowed through a cartridge unit shown generally at 10.
  • the illustrated cartridge unit includes dielectric tubing 12 with three tubing coils 12a, 12b and 12c in series.
  • the cartridge unit 10 may consist of three of the cartridges depicted in the above pending application connected in series or it may be formed with a continuous length of tubing 12.
  • the tubing ends at the opposite ends of the series are provided with conventional connectors 14a and 14b to enable the cartridge unit 10 to be connected to a blood product source and destination.
  • connector 14a may be connected to a blood bag full of blood product and connector 14b may be coupled to an empty blood bag or to a cannula inserted into a patient.
  • a non-invasive flow regulator or paristoltic pump 16 may be provided to control the flow of blood product through tubing 12.
  • the blood product should flow through the tubing at a substantially constant velocity.
  • Cartridge unit 10 is arranged to be used in conjunction with the heating/cooling apparatus shown generally at 20.
  • Apparatus 20 includes a microwave heating chamber 22 having an inlet waveguide 22a and an outlet waveguide 22b and an aperture for receiving the cartridge unit coil 12a.
  • Microwave energy from a microwave transmitter 24 is coupled to heating chamber 22 by way of a standard launch or probe 26 that projects into chamber 22.
  • Transmitter 24 may be controlled by a controller 28 having a control panel or keyboard 28a.
  • the temperature of the liquid flowing through the tubing coil 12a . in chamber 22 is monitored radiometrically using a sensing probe (not shown) similar to probe 26 which is connected by a coaxial conductor 30 to a radiometer 28b in controller 28.
  • Similar sensing probes 32a_ and 32b are present in the inlet and outlet waveguides 22a and 22b to monitor the temperature of the liquid in tubing 12 entering and leaving chamber 22.
  • the controller 28 responds to the temperature measurements provided by the various sensing probes to control the power of the microwave energy injected into chamber 22 via launch probe 26 so as to raise the temperature of the liquid flowing through the tubing coil 12a from an initial value T x which may be, e.g., room temperature, to a selected value T 2 sufficient to inactivate viruses in the blood product, e.g.. 77 ⁇ C. Since the construction and operation of chamber 22, with its probes, radiometric circuitry and controller, is described in detail in the above patent 5,073,167, we will not describe it again here.
  • Apparatus 20 also includes a cooling chamber 34 with an aperture for receiving the tubing coil 12b.
  • Chamber 34 is provided with an inlet tube 34a. and an outlet tube 34b by which a coolant may be circulated through chamber 34 in order to rapidly, e.g., 1 second or less, cool the blood product exiting chamber 22 to a non-destructive temperature T 3 which may be somewhat below the ultimate delivery temperature, e.g., to 30 ⁇ C.
  • the illustrated cartridge unit 10 has, in addition, a third tubing coil 12c which is adapted to be received in a third chamber 22' of apparatus 20.
  • Chamber 22' is another microwave heating chamber which may be substantially identical to chamber 22. Accordingly, its parts have the same numeric identifiers as the corresponding parts in chamber 22. Its function is to controlledly heat the column of liquid flowing through tubing 12 after the liquid has been cooled in chamber 34.
  • the blood product having been overcooled in chamber 34, may be heated in chamber 22' so that when the product leaves apparatus 20 it has a desired delivery temperature T 4 which may be the same as the initial temperature ⁇ . Allowing overshoot during cooling provides more rapid cooling and, in turn, better control of the duration of the short-line heating to reach the desired delivery temperature.
  • a waveguide similar to waveguide 22a with a sensing probe 32a connected to radiometer 28b should be provided to radiometrically measure the temperature of the blood product exiting cooling chamber 34.
  • the temperature T 3 of the liquid as it leaves chamber 34 should be the desired delivery temperature.
  • the blood product is flowed through cartridge unit 10 at a predetermined velocity. That velocity and the tubing 12 dimensions determine the residence time of the blood product in the heating chamber 22.
  • the time/temperature profile of the moving column of liquid may be shaped to produce viral inactivation without undue cell damage.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

Appareil de traitement thermique destiné à l'inactivation virale, des produits sanguins, qui comprend des serpentins disposés en série et pourvus de connecteurs aux extrémités du circuit pour le raccordement de la tubulure à une source et à une destination de produits sanguins. L'appareil comprend également un compartiment de chauffage à micro-ondes disposé de manière à pouvoir recevoir le premier serpentin ainsi qu'une chambre de refroidissement conçue pour accueillir le deuxième serpentin du montage en série. La chambre de chauffage reçoit de l'énergie micro-ondes pour faire passer le produit sanguin d'une température initiale à une température élevée pendant qu'il circule dans le premier serpentin, alors que la chambre de refroidissement est réfrigérée de manière à pouvoir ramener le produit sanguin circulant dans le deuxième serpentin à une température sélectionnée sensiblement inférieure à la température élevée. Un circuit radiométrique permet de contrôler les températures du produit sanguin dans le premier et le deuxième serpentin afin de générer des premier et deuxième signaux de température de retour. Un contrôleur réagit à ces signaux de température en régulant l'émission d'énergie afin de communiquer au produit circulant dans le serpentin le profil de temps/température sélectionné et ainsi le libérer à la bonne température de sortie. L'appareil peut recevoir un troisième serpentin et une deuxième chambre de chauffage pour porter le produit sanguin à la température de sortie après qu'il a été refroidi.
PCT/US1995/012097 1994-09-26 1995-09-25 Traitement thermique destine a l'inactivation virale WO1996009843A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU36388/95A AU3638895A (en) 1994-09-26 1995-09-25 Heat treatment for viral inactivation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US31231094A 1994-09-26 1994-09-26
US08/312,310 1994-09-26

Publications (1)

Publication Number Publication Date
WO1996009843A1 true WO1996009843A1 (fr) 1996-04-04

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1995/012097 WO1996009843A1 (fr) 1994-09-26 1995-09-25 Traitement thermique destine a l'inactivation virale

Country Status (2)

Country Link
AU (1) AU3638895A (fr)
WO (1) WO1996009843A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6268200B1 (en) 1999-01-15 2001-07-31 Lambda Technologies, Inc. Biotherapeutic virus attenuation using variable frequency microwave energy
US6872927B2 (en) 2001-12-26 2005-03-29 Lambda Technologies, Inc. Systems and methods for processing pathogen-contaminated mail pieces

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3817603A1 (de) * 1988-05-24 1989-11-30 Michael Stieglitz Extrakorporale-hyperthermie-geraet
US5073167A (en) * 1987-06-26 1991-12-17 M/A-Com, Inc. In-line microwave warming apparatus

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5073167A (en) * 1987-06-26 1991-12-17 M/A-Com, Inc. In-line microwave warming apparatus
DE3817603A1 (de) * 1988-05-24 1989-11-30 Michael Stieglitz Extrakorporale-hyperthermie-geraet

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6268200B1 (en) 1999-01-15 2001-07-31 Lambda Technologies, Inc. Biotherapeutic virus attenuation using variable frequency microwave energy
US6872927B2 (en) 2001-12-26 2005-03-29 Lambda Technologies, Inc. Systems and methods for processing pathogen-contaminated mail pieces

Also Published As

Publication number Publication date
AU3638895A (en) 1996-04-19

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