WO2002092161A1 - Analyseur de particules miniaturise - Google Patents

Analyseur de particules miniaturise Download PDF

Info

Publication number
WO2002092161A1
WO2002092161A1 PCT/US2002/014253 US0214253W WO02092161A1 WO 2002092161 A1 WO2002092161 A1 WO 2002092161A1 US 0214253 W US0214253 W US 0214253W WO 02092161 A1 WO02092161 A1 WO 02092161A1
Authority
WO
WIPO (PCT)
Prior art keywords
particle analyzer
particles
labeled
recited
analyzed
Prior art date
Application number
PCT/US2002/014253
Other languages
English (en)
Inventor
Carol Gebert
Robert W. Gray
Original Assignee
Biophan, Llc
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 Biophan, Llc filed Critical Biophan, Llc
Publication of WO2002092161A1 publication Critical patent/WO2002092161A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/076—Permanent implantations

Definitions

  • a miniature particle analyzer adapted to both detect and treat mammalian cells.
  • Flow cytometers are well known to those skilled in the art.
  • United States patent 6,097,485 discloses a miniature flow cytometer adapted to measure laser-induced fluorescence.
  • a particle analzyer which comprises means for acquiring particles of cellular material from a living body, a means for labeling said particles of cellular material within a bodily fluid with a label to produce labeled particles, means for analyzing the labeled particles, and means for sorting the labeled particles.
  • Figure 1 is a flow diagram of one preferred process of the invention
  • Figure 2 is a schematic of one preferred assembly of the invention for acquiring, wherein the assembly is comprised of a particle analyzer;
  • Figures 3 A, 3B, and 3C schematically illustrate the actions of the pump of the assembly depicted in Figure 2;
  • Figure 4 is a schematic diagram of one preferred means for preparing a bodily fluid for analysis;
  • Figure 5 is a schematic of the detection/treatment system of the particle analyzer assembly
  • Figure 6 is a schematic of the particle analyzer assembly in relation to the location of bodily fluids
  • Figure 7 is a schematic of one preferred means for maintaining a viable bodily fluid
  • Figure 8 is a schematic of a particle analyzer disposed within a living body
  • Figure 9 is a schematic of a particle analyzer disposed outside of a living body
  • Figure 1 is a flow diagram of one preferred process 10 for analyzing, treating, and maintaining certain bodily fluids. Acquiring In step 12 of the process, the bodily fluids are acquired.
  • the body fluids which are typically acquired include, e.g., blood, lymph, spinal fluid, semen, fat cells, stem cells, bone marrow, and the like.
  • the body fluids are acquired by means of the sampling system described in United States patent 6,159,164, the entire disclosure of which is hereby incorporated by reference into this specification.
  • the system of this patent samples a body fluid through a tube attached to a patient's body; and the system is operable by a user having a hand, including a palm, a thumb, and at least a first finger and a second finger.
  • the system comprises a fluid sampling site connected to the tube; means for receiving the tube; means for forming a chamber; means for selectively increasing the size of the chamber to a maximum volume and for decreasing the size of the chamber to a minimum volume, the means for increasing and decreasing the size of the chamber being operable by moving the first and second fingers or the thumb in a flexion movement toward the palm to achieve the maximum volume of the chamber, the means for increasing and decreasing the size of the chamber also being operable by moving the first and second fingers or the thumb in a flexion movement toward the palm to achieve the minimum volume of the chamber such that the same motion of the user's first and second fingers can selectively accomplish the maximum volume to aspirate fluid from the patient's body to the fluid sampling site or accomplish the minimum volume to expel the fluid into the patient's body.
  • Figures 2 and 3 indicate another acquiring assembly that may be used.
  • Figure 2 outlines the pump's bodily location and Figure 3 details the pumping action.
  • a patient has disposed within her body, beneath her diaphragm 16, a pump 18 that is actuated by the movement of diaphragm 16 in the direction of arrows 19 and 20.
  • the pump 18 has a deformable and elastic casing 22.
  • casing 22 When casing
  • the pump 18 comprises one-way flow valve 30, which allows fluid flow only in the direction of arrow 32; and it also comprises one-way flow valve 34, which only allows flow in the direction of arrow 36. Thus, when casing 22 is compressed, fluid only may flow through line
  • the pump 18 is shown disposed beneath the patient's diaphragm 16, it will be apparent that such pump 18 may be disposed beneath or nearby other parts of a body which expand and contract. Thus, by way of illustration and not limitation, the pump 18 may be positioned between lung and ribcage, between muscle and bone, between a heart and a sternum, and the like.
  • FIG. 3 A, 3B, and 3C illustrate the operation of pump 18 in its intake phase
  • the pump 18 is compressed when the diaphragm 16 moves in the direction of arrow 20; and it is allowed to return to its non-compressed state when the diaphragm 16 moves in the direction of arrow 19.
  • the pump 18 is replaced by a piezoelectric assembly (not shown) that, upon pressure being applied to it, produces a difference of potential sufficient to actuate a pump to which it is electrically connected.
  • the bodily fluid which has been acquired is then prepared for analysis.
  • a biological sample is contacted with two or more blood cell populations with a selective nucleic acid specific blocking agent to form a sample mixture.
  • the sample mixture is then contacted with a cell membrane permeant, red- excited dye without significantly disrupting cellular integrity of the cells to form a dyed sample mixture.
  • the dyed sample mixture is excited with light in a single red wavelength; and, thereafter, fluorescence emitted from different cell populations in the dyed sample mixture is measured, wherein the fluorescence emitted from one blood cell population is distinguishable from the fluorescence emitted from another blood cell population.
  • the appropriate dye(s) or other markers are fed to reservoir 70 by line 72 and, in response to one or more signals from controller 64, feeds such dye(s) into injector 74 and thence into line 26, where the dye(s) mix with the fluid disposed within such line 26 and selectively label them.
  • the marker/label may be removed from the fluid by conventional means.
  • the label may be removed by means of an adsorption column 78 and/or by other adsorption means.
  • the dye may be removed by other means, including chemical means.
  • processes for stripping dyes or decolorizing various materials are known in the art. For example, U.S. Pat. No.
  • 4,227,881 discloses a process for stripping dyes from textile fabric that includes heating an aqueous solution of an ammonium salt, a sulfite salt and an organic sulfonate to at least 140 degrees F. (60 degrees C.) and adding the dyed fabric to the heated solution while maintaining the temperature of the solution.
  • U.S. Pat. No. 4,783,193 discloses a process for stripping color from synthetic polymer products by contacting the colored polymer with a chemical system. It will be apparent that one can use one of several different physical and/or chemical means of removing the dye/marker/label from the bodily fluid; the aforementioned description is illustrative and not limitative.
  • a purified bodily fluid is returned via line 50/52 to either the body or a reservoir.
  • additional material needed for such process may be charged via line 80, and/or dye and/or other waste material may be removed via line 80.
  • the reservoir 70 may contain one or more labels/markers, and/or it may contain diluent to preferably dilute the bodily fluids so that preferably only one cell passes by any particular point in flow chamber 76 at anyone time. As will be apparent, this
  • laminar flow condition facilitates the analyses of the bodily fluid by optical means.
  • step 82 of the process the labeled bodily fluid is analyzed.
  • a light source 84 is caused to focus on flow chamber 76.
  • the amount of light transmitted through flow chamber 76 will vary with the properties of the bodily fluid within such chamber; see, e.g., United States patents 6,197,756,
  • the light transmitted through flow chamber 76 is detected by detector 86 which may, e.g., be a photodetector. Data is fed from detector 86 to controller 88.
  • Controller 88 is equipped with a database indicating the properties of normal bodily fluids. The property of any particular bodily fluid being analyzed can be compared with this database to determine whether they correlate. A lack of correlation may indicate a disease state, which can be thereafter treated by the particle analyzer 44.
  • step 90 data is collected from the analysis conducted in controller 88. Historical data may also be fed to the data collection device, either before, during, or after the analysis 82 of the bodily fluid.
  • the collection of data in step 90, and its use, may be done in accordance with United States patent 6,197,593, the entire disclosure of which is hereby incorporated by reference into this specification.
  • Data from data collection step 90 may be added to from external sources. Alternatively, data from data collection step 90 may be exported to one or more external devices.
  • analysis step 82 and data collection step 90 indicate the presence of a dangerous abnormal condition within the bodily fluid
  • an external alarm is activated to warn the patient.
  • the bodily fluid may be charged via line 92 to treatment step 94. As is indicated in
  • treatments 110 may be conducted inline with analysis 108 within the flow chamber
  • injector 96 is operatively connected to both detector 86 and controller 88 and, in response to signals there from, feeds energy and/or material to the bodily fluid to treat it.
  • electrical discharge 100 by means such as, e.g., electroporation.
  • s ⁇ ch material may be fed to injector 96 via line 115 from reservoir 116.
  • the controller 64 can cause the closure of valves 112 and 114 so that fluid disposed between such valves cannot flow.
  • any abnormal cell detected at point 108 may be treated at point 110, e.g., the controller 88 determining precisely where such particular cell is at any point in time.
  • the cells or bodily fluid treated in step 94 may be returned to the body in step 122.
  • body fluids that have been analyzed by particle analyzer 44 may be fed via line 50 to vessel 41, which may be the same or different from the blood vessel 40, from which the bodily fluid was sampled.
  • such analyzed bodily fluids may be fed via line 52 to reservoir 54 that, in the embodiment depicted, is disposed in a blood vessel 56. Sorting
  • the cells analyzed in step 82 may be sorted in sorting step 118 according to criteria detected by the detector 86 and analyzed by controller 88.
  • this sorting step one may selectively segregate and collect certain cells within the bodily fluid.
  • conventional particle analyzer sorters in this step; see, e.g., United States patents 5,985,216 and 5,998,212, the entire disclosure of each of which is hereby incorporated by reference into this specification.
  • stem cells are sorted from the bodily fluid.
  • the identification and separation of such stem cells maybe conducted by conventional means such as, e.g., the means disclosed in United States patent 5,665,557, the entire disclosure of which is hereby incorporated by reference into this specification.
  • the stem cells sorted in step 118 may be collected and thereafter used for many different purposes. Maintenance
  • Figure 7 is a schematic of a means for maintaining bodily fluid (and/or a portion thereof) in maintenance step 120. Referring to Figure 7, some or all of the cells that have been sorted in sorting step 118 may be passed via line 52 to reservoir 54. In one embodiment, not shown, sorting step 118 is bypassed and bodily fluid is directly passed into reservoir 54.
  • reservoir 54 is disposed within blood vessel 56, and which is composed of porous material.
  • reservoir 54 may be disposed adjacent to a blood vessel, and/or be disposed adjacent to the intestines. This allows all necessary nutrients and supplies to be available to the retained cells. It also allows for waste products to be removed from reservoir 54.
  • the porous material has a pore size that allows cells to remain within reservoir 54, but which allows nutrients and waste products to diffuse freely. Removal
  • cells may be removed from the maintenance chamber, in removal step 124.
  • one may remove some or all of the sorted material in step 118 and maintained in reservoir 54 by means, e.g., of syringe 60 and line 61.
  • One may also withdraw fluid from reservoir 54 into blood vessel 56 by means of line 58.
  • the particle analyzer 44 may be disposed either within or without the patient's body-
  • a particle analyzer 44 is disposed in a patient's body.
  • the particle analyzer 44 is disposed beneath a patient's skin, in the abdominal cavity.
  • the particle analyzer 44 may be implanted within the patient's body by conventional means.
  • one may implant particle analyzer 44 by the method disclosed in United States patent 6,198,950, the entire disclosure of which is hereby incorporated by reference into this specification.
  • the implantable device is implanted under the skin in such a manner that the cannula projects into a blood vessel.
  • particle analyzer 44 is disposed outside the body 14 rather than inside it.
  • analyzer 44 may be removably attached to the body 14 by conventional means such as, e.g., belt 48 extending around the torso of the patient.
  • the bodily fluid is sampled from, returned to or maintained in the body via cannulae tubes 26, 38, 50 or 52.
  • the particle analyzer 44 preferably has a weight of less than 12 pounds and, more preferably, weighs less than about 6 pounds. In one embodiment, the particle analyzer 44 is made from miniaturized components and weighs less than about 3 pounds. Technologies that enable this size and weight to be achieved include low energy lasers and advanced flow chambers that allow cells to flow in a narrowly focused laminar flow stream. Reference may be had, e.g., to United States patents 5,995,860 (implantable sensor for control of blood constituent levels), 6,057,149 (microscale devices adapted to move and mix microdroplets through microchannels), 6,119,031 (miniature spectrometer), 6,152,889 (body fluid sampler), 6,198,950
  • controller 64 is operatively connected to a power source 66.
  • pump 18 the mechanical action of pump 18 generates the power stored as power source 66.
  • every output cycle of pump 18 provides some hydraulic pressure via line 68 to pump 66.
  • This hydraulic pressure is converted into electrical power by conventional means such as, e.g., piezoelectric means.
  • power source 66 is a battery.
  • the battery may be rechargeable.
  • the battery is recharged by electromagnetic radiation.
  • the electromagnetic radiation may be transferred from a source disposed within the patient's body; or it may be transferred from a source external to the patient's body.
  • a magnetic field may be produced by passing alternating current through a wire or coil, and this alternating magnetic field may be transmitted through a patient's skin into his body and coupled with a transducer, which produces alternating current from the alternating magnetic field.
  • material and/or energy is fed to power source 66 via a line (not shown), and this material and/or energy is adapted to furnish power to power source 66.
  • the material charged to power source 66 may undergo and/or facilitate a reaction, which produces energy consumed by power source 66.
  • controllers including controller 64, controller 88 and any others used in other embodiments are able to be programmed with externally- generated signals 65, as diagrammed in Figures 4 and 5. All controllers are additionally able to interface with and import data from external databases (not shown).
  • the casing 22, of pump 18 is made from a flexible, elastic biocompatible material.
  • the particle analyzer is made from biocompatible materials such as surgical steel or encased in biocompatible materials. All cannulae and tube are made from flexible, biocompatible materials.
  • Flow chamber 76 is preferably transparent to the desired light source.
  • particle analyzer 44 is sampling blood. In another embodiment, not shown, the particle analyzer 44 is so disposed that it samples bodily liquids such as, e.g., lymph, bone marrow, spinal fluid, and the like. As will be apparent to those skilled in the art, the particle analyzer 44 is adapted to sample and analyze and treat unmodified bodily liquids, that is, bodily liquids occurring in their natural state within the body. It is to be understood that the aforementioned description is illustrative only and that changes can be made in the apparatus, in the ingredients and their proportions, and in the sequence of combinations and process steps, as well as in other aspects of the invention discussed herein, without departing from the scope of the invention as defined in the following claims.

Abstract

Analyseur de particules contenant un dispositif (12) permettant d'acquérir des particules de matière cellulaire d'un corps vivant, un dispositif (42) permettant d'étiqueter les particules de matière cellulaire afin de produire des particules étiquetées, un dispositif (82) permettant d'analyser les particules étiquetées afin de produire des particules analysées et étiquetées, un dispositif (118) permettant de trier les particules analysées et étiquetées afin de produire des particules étiquetées et triées, et un dispositif (120) permettant de maintenir une partie des particules analysées et étiquetés dans un état viable.
PCT/US2002/014253 2001-05-10 2002-05-06 Analyseur de particules miniaturise WO2002092161A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US85287601A 2001-05-10 2001-05-10
US09/852,876 2001-05-10

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WO2002092161A1 true WO2002092161A1 (fr) 2002-11-21

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Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7713687B2 (en) 2000-11-29 2010-05-11 Xy, Inc. System to separate frozen-thawed spermatozoa into x-chromosome bearing and y-chromosome bearing populations
US7723116B2 (en) 2003-05-15 2010-05-25 Xy, Inc. Apparatus, methods and processes for sorting particles and for providing sex-sorted animal sperm
US7758811B2 (en) 2003-03-28 2010-07-20 Inguran, Llc System for analyzing particles using multiple flow cytometry units
US7820425B2 (en) 1999-11-24 2010-10-26 Xy, Llc Method of cryopreserving selected sperm cells
US7833147B2 (en) 2004-07-22 2010-11-16 Inguran, LLC. Process for enriching a population of sperm cells
US7838210B2 (en) 2004-03-29 2010-11-23 Inguran, LLC. Sperm suspensions for sorting into X or Y chromosome-bearing enriched populations
US7855078B2 (en) 2002-08-15 2010-12-21 Xy, Llc High resolution flow cytometer
US7929137B2 (en) 1997-01-31 2011-04-19 Xy, Llc Optical apparatus
US8137967B2 (en) 2000-11-29 2012-03-20 Xy, Llc In-vitro fertilization systems with spermatozoa separated into X-chromosome and Y-chromosome bearing populations
US8486618B2 (en) 2002-08-01 2013-07-16 Xy, Llc Heterogeneous inseminate system
US8497063B2 (en) 2002-08-01 2013-07-30 Xy, Llc Sex selected equine embryo production system
US8543207B2 (en) 2004-12-17 2013-09-24 Cardiac Pacemakers, Inc. MRI operation modes for implantable medical devices
US8554335B2 (en) 2007-12-06 2013-10-08 Cardiac Pacemakers, Inc. Method and apparatus for disconnecting the tip electrode during MRI
US8565874B2 (en) 2009-12-08 2013-10-22 Cardiac Pacemakers, Inc. Implantable medical device with automatic tachycardia detection and control in MRI environments
US8897875B2 (en) 2007-12-06 2014-11-25 Cardiac Pacemakers, Inc. Selectively connecting the tip electrode during therapy for MRI shielding
US8977356B2 (en) 2009-02-19 2015-03-10 Cardiac Pacemakers, Inc. Systems and methods for providing arrhythmia therapy in MRI environments
US9365822B2 (en) 1997-12-31 2016-06-14 Xy, Llc System and method for sorting cells
US9561378B2 (en) 2008-10-02 2017-02-07 Cardiac Pacemakers, Inc. Implantable medical device responsive to MRI induced capture threshold changes
US11230695B2 (en) 2002-09-13 2022-01-25 Xy, Llc Sperm cell processing and preservation systems

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Cited By (38)

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US7929137B2 (en) 1997-01-31 2011-04-19 Xy, Llc Optical apparatus
US9422523B2 (en) 1997-12-31 2016-08-23 Xy, Llc System and method for sorting cells
US9365822B2 (en) 1997-12-31 2016-06-14 Xy, Llc System and method for sorting cells
US7820425B2 (en) 1999-11-24 2010-10-26 Xy, Llc Method of cryopreserving selected sperm cells
US8652769B2 (en) 2000-11-29 2014-02-18 Xy, Llc Methods for separating frozen-thawed spermatozoa into X-chromosome bearing and Y-chromosome bearing populations
US9879221B2 (en) 2000-11-29 2018-01-30 Xy, Llc Method of in-vitro fertilization with spermatozoa separated into X-chromosome and Y-chromosome bearing populations
US7771921B2 (en) 2000-11-29 2010-08-10 Xy, Llc Separation systems of frozen-thawed spermatozoa into X-chromosome bearing and Y-chromosome bearing populations
US7713687B2 (en) 2000-11-29 2010-05-11 Xy, Inc. System to separate frozen-thawed spermatozoa into x-chromosome bearing and y-chromosome bearing populations
US8137967B2 (en) 2000-11-29 2012-03-20 Xy, Llc In-vitro fertilization systems with spermatozoa separated into X-chromosome and Y-chromosome bearing populations
US8497063B2 (en) 2002-08-01 2013-07-30 Xy, Llc Sex selected equine embryo production system
US8486618B2 (en) 2002-08-01 2013-07-16 Xy, Llc Heterogeneous inseminate system
US7855078B2 (en) 2002-08-15 2010-12-21 Xy, Llc High resolution flow cytometer
US11261424B2 (en) 2002-09-13 2022-03-01 Xy, Llc Sperm cell processing systems
US11230695B2 (en) 2002-09-13 2022-01-25 Xy, Llc Sperm cell processing and preservation systems
US8709825B2 (en) 2003-03-28 2014-04-29 Inguran, Llc Flow cytometer method and apparatus
US9040304B2 (en) 2003-03-28 2015-05-26 Inguran, Llc Multi-channel system and methods for sorting particles
US11718826B2 (en) 2003-03-28 2023-08-08 Inguran, Llc System and method for sorting particles
US11104880B2 (en) 2003-03-28 2021-08-31 Inguran, Llc Photo-damage system for sorting particles
US7943384B2 (en) 2003-03-28 2011-05-17 Inguran Llc Apparatus and methods for sorting particles
US8664006B2 (en) 2003-03-28 2014-03-04 Inguran, Llc Flow cytometer apparatus and method
US8709817B2 (en) 2003-03-28 2014-04-29 Inguran, Llc Systems and methods for sorting particles
US7799569B2 (en) 2003-03-28 2010-09-21 Inguran, Llc Process for evaluating staining conditions of cells for sorting
US8748183B2 (en) 2003-03-28 2014-06-10 Inguran, Llc Method and apparatus for calibrating a flow cytometer
US10100278B2 (en) 2003-03-28 2018-10-16 Inguran, Llc Multi-channel system and methods for sorting particles
US9377390B2 (en) 2003-03-28 2016-06-28 Inguran, Llc Apparatus, methods and processes for sorting particles and for providing sex-sorted animal sperm
US7758811B2 (en) 2003-03-28 2010-07-20 Inguran, Llc System for analyzing particles using multiple flow cytometry units
US7723116B2 (en) 2003-05-15 2010-05-25 Xy, Inc. Apparatus, methods and processes for sorting particles and for providing sex-sorted animal sperm
US7892725B2 (en) 2004-03-29 2011-02-22 Inguran, Llc Process for storing a sperm dispersion
US7838210B2 (en) 2004-03-29 2010-11-23 Inguran, LLC. Sperm suspensions for sorting into X or Y chromosome-bearing enriched populations
US7833147B2 (en) 2004-07-22 2010-11-16 Inguran, LLC. Process for enriching a population of sperm cells
US8543207B2 (en) 2004-12-17 2013-09-24 Cardiac Pacemakers, Inc. MRI operation modes for implantable medical devices
US8886317B2 (en) 2004-12-17 2014-11-11 Cardiac Pacemakers, Inc. MRI operation modes for implantable medical devices
US8897875B2 (en) 2007-12-06 2014-11-25 Cardiac Pacemakers, Inc. Selectively connecting the tip electrode during therapy for MRI shielding
US8554335B2 (en) 2007-12-06 2013-10-08 Cardiac Pacemakers, Inc. Method and apparatus for disconnecting the tip electrode during MRI
US9561378B2 (en) 2008-10-02 2017-02-07 Cardiac Pacemakers, Inc. Implantable medical device responsive to MRI induced capture threshold changes
US8977356B2 (en) 2009-02-19 2015-03-10 Cardiac Pacemakers, Inc. Systems and methods for providing arrhythmia therapy in MRI environments
US9381371B2 (en) 2009-12-08 2016-07-05 Cardiac Pacemakers, Inc. Implantable medical device with automatic tachycardia detection and control in MRI environments
US8565874B2 (en) 2009-12-08 2013-10-22 Cardiac Pacemakers, Inc. Implantable medical device with automatic tachycardia detection and control in MRI environments

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