WO1996017635A1

WO1996017635A1 - Activation of molecular processes by controlled electromagnetic stimulation

Info

Publication number: WO1996017635A1
Application number: PCT/IB1995/001113
Authority: WO
Inventors: Michael Richard Williams
Original assignee: Lifetech Corp
Current assignee: Lifetech Corp
Priority date: 1994-12-09
Filing date: 1995-12-11
Publication date: 1996-06-13
Anticipated expiration: 1997-06-09
Also published as: GB9424913D0; AU3935095A

Abstract

A synergistic effect is achieved when biological fluids such as blood, seminal fluids or bone marrow is treated by a conventional treatment process while at the same time being subjected to a pulsed electromagnetic field. The treatment process may comprise administration of ozone or an oxygen/ozone gas mixture to inactivate viruses within the blood or other fluid, or administration of a drug. Preferably, the fluid is treated externally to the body, for example in a unit of desired volume. Treatment in vivo is also contemplated.

Description

ACTIVATION OF MOLECULAR PROCESSES BY CONTROLLED ELECTROMAGNETIC STIMULATION

FIELD OF THE INVENTION

The present invention relates broadly to the enhancement of treatment processes carried out on human or animal body fluids such as whole blood, serum, plasma, and packed red blood cells; and as well, bone marrow and seminal fluids, including blood by-products, blood components and related by-products or substances. Also included are fluids that may be administered to mammals, including humans, such as saline or glucose intravenous solutions and the like; and fluid nutrient media such as are employed to grow bacteria, viruses, cells, parasites, and the like. For convenience, all of the aforementioned fluids will hereafter be referred to collectively as "biological fluids".

PRIOR ART

The present invention has been evolved primarily, but not exclusively, in connection with the ozone treatment of blood and blood products. Gas sterilization of blood using ozone has been widely reported and is discussed, for example, in an article entitled "Are Worry-Free Transfusions Just a Whiff of Ozone Away?" by Albert C.

Baggs in the Canadian Medical Association Journal 1983, Volume 148 No. 7 at page

1 155. The use of ozone to sterilize emergency blood supplies is also discussed in Research and Development Bulletin No. 234 September, 1992, Supply & Services

C-anada. An example of a patent literature reference is U.S. Patent No. 4,632,980 (Zee et al.) "Ozone Decontamination of Blood and Blood Products".

Several techniques for effecting oxygenating treatment of blood with ozone are described in such patent. These include contacting the blood or blood fraction (i.e. serum or the like) with the ozone by passing the fluid medium as a film through a chamber containing the ozone, or by passing the blood through porous tubing which are present in a chamber containing the ozone. The technique wherein the blood is contacted as a film is exemplified in this patent by the use of rotating vessels such as rotating bottles, which act to form the blood into a relatively thin film over most of the bottle interior surface, with the ozone being passed through the bottle interior. The concentration of ozone in the treating atmosphere is said to be in the range of about 1 to 100 ppm, and usually in the range of from about 1 to 20 ppm. In the actual experimental system described, the ozone level was at approximately 2 ppm, and apparently was even lower since the ozone was mixed with filtered air before being contacted with the blood in the rotating bottle. The patentee emphasizes the need for what are referred to as "mild" contact conditions, apparently referring to the very low concentrations of ozone which are used.

It has also been known in the prior art to utilize other methodology to oxygenate blood for several of the purposes previously discussed. In Jones, U.S. Patent No. 2,287,901, for example, blood is sprayed into a contained oxygen atmosphere so that the blood in the form of spray droplets may be exposed to the said atmosphere.

In the present inventor's commonly assigned U.S. Patent No. 5,366,696, improvements in oxygenation apparatus are disclosed, for oxygenating a sprayable biological fluid by spraying. By the term "sprayable biological fluid" is meant that the biological fluid behaves mechanically like a liquid, and can be dispersed into a gas phase as discrete droplets. Such a fluid, e.g. in the case of blood, need not be entirely liquid or homogeneous, but can e.g. consist of minute bodies such as cells contained in a liquid carrier.

In the apparatus of the said 5.366.696 patent, a chamber is provided for receiving and collecting the liquid ( such as blood) which is to be contacted with the oxygenating gas, such as ozone. Blood or other biological fluid to be oxygenated is provided to a reservoir. A gas/biological fluid delivery tube, comprising an outer biological fluid delivery tube and a coaxially spaced inner gas delivery tube, extends into the reservoir, where the outer tube terminates at an open end. The inner tube extends through the reservoir to a point outside the chamber, so that it may receive oxygenating gas at its input end. The distal end of the delivery tube comprises a spray nozzle. The venturi effect generated by flow of the oxygenating gas from the gas delivery tube discharge to a spaced nozzle orifice causes blood in the reservoir to be aspirated into and contacted with the gas stream, and to issue from the nozzle orifice as a dispersed spray of liquid droplets. A spray collection surface is located within the chamber in the spray path of the liquid droplets, which collects substantially the entirety of the droplets of oxygenated liquid, which are then provided to a discharge conduit. This collection surface is spaced from the spray orifice a distance selected so that the droplets impinge on the collection surface at relatively low velocity and form a film on the surface, where further contact with the gas can also be effected. The method of contact achieved in the said apparatus is very effective in that high energy mechanical impact of the droplets with the collection surface is avoided, whereby hemolysis effects are eliminated or greatly reduced. Much higher concentrations of ozone can be safely utilized in this apparatus than have heretofore been taught.

Treatment of patients using pulsed electromagnetic fields has also been proposed. For example, the effect of pulsing electromagnetic field therapy on systems of multiple sclerosis (MS) is described in a paper by Guseo published in the Journal of Bio- Electricity 6(l),23-35 1987 and entitled "Pulsing Electromagnetic Field Therapy of Multiple Sclerosis by the Gyuling-Bordacs Device: Double-Blind, Cross-Over and Open Studies". The effects of low frequency electromagnetic fields on blood circulation have also been discussed in a paper under that title by Lau of the Department of Microbiology. School of Medicine. Loma Linda University. Loma Linda. California. SUMMARY OF THE INVENTION

It has now been found that a synergistic effect is obtained in the treatment of biological fluids using treatment processes that are known in themselves, if the fluids are treated and at the same time subjected to a controlled pulsed electromagnetic field.

It is believed that the pulsed electromagnetic field will increase the susceptibility of the cells or other structures within the fluid to the effect of the other treatment process. This may occur as a result of one or more mechanisms that take place at the cellular level including enhancement of ion exchange, proton precession and, where red blood cells are present, domain rotation of ferrous compounds in those cells.

The treatment mechanism used in conjunction with the electromagnetic field may include one or more of a number of treatment mechanisms that are known in themselves, including ozone/oxygen treatment, treatment with drugs such as anti -viral or anti-cancer compounds, cultures or other known treatment mechanisms.

Preferably, the blood or other biological fluid is withdrawn from the body and treated externally, although ii is possible that the treatment may be applied directly to the patient. For example, an electromagnetic field could be applied to the whole or part of a patient's body while the drug or other therapy is in progress. Treatment external to the body is believed to be preferable on the basis that there would then be no interference or "screening" of the treatment by other mechanisms that might be going on within the body, or screening or other disturbances caused by body organs.

Where the blood or other fluid is treated externally of the patient, a small volume of the fluid (e.g. 10-500 mL) will be withdrawn from the patient (or from a supply in a blood bank or the like ) and placed in a special container that is designed to infuse ozone/oxygen gas mixtures or drugs appropriate to the treatment required. The special container is surrounded with a coil which is designed to apply a pulsed electromagnetic field to the fluid within the container. The biological fluid can also be treated on a continuous basis, e.g. by passing a continuous stream of the fluid through a spray apparatus of the type disclosed in the aforementioned 5,366,696 patent, while simultaneously imposing .an electromagnetic field in the region of the intermixed spray droplets and ozone.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the invention may be more clearly understood, reference will now be made to the accompanying drawings which illustrate a number of preferred embodiments of the invention by way of example, and in which:

Figure 1 is a schematic illustration of a blood treatment container surroimded by a coil, for treating blood in accordance with the invention;

Figure 2 is a schematic illustration in more detail of the container shown in Figure 1 ;

Figure 3 is a side view illustrating an alternative form of container;

Figure 4 is a detail perspective view of part of the container of Figure 2;

Figure 5 is a simplified schematic cross-sectional view illustrating use of the invention in conjunction with a spray device in which a biological fluid is being oxygenated;

Figure 6 is a schematic illustration of an arrangement of electromagnetic coils for use in a "whole body" treatment apparatus according to the invention;

Figures 7 and 8 illustrate an alternative configuration of coils that may be used for whole body treatment or for treating a specific limb or other part of the body; Figure 9 illustrates an arrangement for energizing the coils in pairs, in an arrangement such as that shown in Figure 7 with additive flux lines or fields;

Figure 10 shows in detail the flux lines that are achieved in the arrangement of Figure 9;

Figure 11 is a more detailed illustration of part of Figure 9 showing opposing flux lines or fields;

Figure 12 shows an alternative arrangement for energizing the coils of Figure 9 with additive flux lines or fields;

Fig. 13 shows the flux lines in a cross-section of one of the actual coils of Fig. 12 with additive flux lines or fields;

Figures 14 and 15 illustrate cross sectional and perspective views of a specific coil design;

Figure 16 is a diagrammatic illustration of a shielding method that may be used for the coils;

Figures 17 and 18 illustrate possible coil switching arrangements; and

Figures 19 and 20 illustrate electromagnetic field patterns.

DESCRIPTION OF PREFERRED EMBODIMENTS

Referring first to Figure 1, a blood treatment container is generally indicated by reference numeral 20 and is of generally cylindrical form with three inlet/outlet ports 22 extending upwardly from its top surface. Typically, the container itself is molded in a suitable plastic material. The container is shown disposed within a coil 24 that is wound in a helical configuration so as to define a central space of slightly larger diameter than the container. The ends of the coil are connected to a conventional pulse train generator represented by the square wave form indicated at 26 in Figure 1. The generator is capable of applying a continuous train of pulses to the coil imposing a pulsed electromagnetic field on the blood or other liquid within container 20. Allthough the pulsed wave form is illustrated as a square wave, other pulsed shapes known in the art can be used, such as a half-sine, saw tooth, or a triangular wave shape.

Figure 2 shows container 20 in more detail and separately from coil 24. The ports 22 at the top of the container comprise a blood inlet port 22a at one side of the container, a central port 22b through which an ozone/oxygen gas mixture can be delivered to the container, and a gas exhaust port 22c diametrically opposite inlet port 22a. The inlet and outlet ports 22a and 22c respectively simply communicate with the interior volume of the container. Port 22b on the other hand is defined by the upper end portion of a tube 28 which is disposed generally on the vertical centerline of the container, and from which radiate outwardly a series of thin perforated tubes 30 through which the oxygen/gas mixture is bubbled into the blood within container 22. The tubes are disposed in groups that are vertically spaced along tube 28. and a separator plate 32 in the form of a fine mesh extends across the container above each group of tubes, to form a barrier preventing bubbles rising within the container. In this particular embodiment, there are three groups of tubes with one pair of tubes in each group, although it is to be understood that both the number of groups and the number of tubes in each group can vary.

Figure 3 illustrates a generally similar form of container, denoted 20' but which has only an inlet port 22a' and an outlet 22c'. In this case, the ozone/oxygen gas mixture is introduced through a tube 34 having respective limbs 36 and 38 that extend laterally from the tube at different levels within the container, and above each of which is disposed a separator plate 32 of the same form as the separator plates shown in Fig. 2.

Figure 4 essentially shows a modification of Fig. 2. and also serves to illustrate in some detail the effect of the separator plate 32 within any of the containers illustrated. As seen in Figure 4, the container has a central vertical tube 28' similar to tube 28 of Fig. 2. However, in this embodiment, the tube itself is perforated (as indicated for example at 40), so that ozone/oxygen bubbles escape into the blood directly from the tube. In all of the embodiments, the bubbles collect below the mesh (typically 50-400 mesh size) for ready absorption by the blood or other liquid in the container. In practice, bubbling will be of short duration, sufficient to build up a layer of bubbles at the underside of each separator plate and provide for a predetermined ozone concentration given the amount of blood within the container. Bubbling will take place immediately before or during application of a pulsed electromagnetic field to the blood by means of the coil 24 (Figure 1 ).

In all of the embodiments of Figures 1 to 4, the blood or other body fluid is treated externally of the body in volumes or "units" typically in the range 10-500 mL. i.e. the blood is treated on a batch basis. After treatment, the blood unit is discharged from the container and. for example, returned to the patient or to a blood storage facility. In this connection, it should be noted that it may be necessary to treat only a relatively small volume of blood per patient, in order to provide an effective treatment.

In Figure 5 a schematic cross-section appears illustrating use of the invention in conjunction with a spray device 60 in which a biological fluid such as blood is being oxygenated. The general mode of operation of the device is similar to that of the aforementioned U.S. patent No. 5.366.696; and thus it may be assumed that blood or other biological fluid of interest is to be oxygenated by treatment with ozone, the blood being intermixed with the ozone as a highly dispersed spray of droplets. The ozone flow is provided to the nozzle 62 via conduit 64, whereby the venturi effect generated in the region 66 aspirates blood from a reservoir (not shown) via the conduit 68, with the ozone and blood being mixed at region 66 and then discharged as a spray of fine droplets from nozzle orifice 70. The nozzle is contained within the chamber 72, into which the spray is discharged. The oxygenated droplets are collected at the inner walls of chamber 72, and then the oxygenated blood or other biological fluid is taken as product via outlet 74. Excess and spent gases are discharged at outlet 75. In accordance with the present invention, the chamber is formed of a dielectric insulator such as a suitable plastic, and is enveloped by a coil 76, the function of which is analogous to coil 24 of Figure 1. Input terminals 78 enable a pulsed e.m.f. to be applied to coil 76. which as in prior embodiments, generates a pulsed electromagnetic field within chamber 72. and thus throughout the region of the spray. It will be evident that a film of blood deposited on the chamber interior walls, or a film that may be formed in any other manner in the interior of the chamber (e.g. a falling film), can be subjected to the electromagnetic field in like manner.

The electromagnetic field of the invention will generally be pulsed at a frequency of no higher than 85 Hz. with 5 to 85 Hz being preferable, and 10 to 15 Hz being more preferable. Field intensities should preferably be in the 1 to 25 gauss range, but considerably higher fields can be used, depending upon the physical and biological properties of the fluids being treated, and the duration of exposure to the field. With most biological fluids the upper limit will effectively be that at which substantial cellular damage occurs, and in some instances this can be in the hundreds or even thous-ands of gauss range.

As noted previously, the treatment provided by the invention may be applied directly to a patient so that the blood or other fluid is in effect treated within the body. Fig. 6 shows an apparatus designed to permit such "whole body" treatment. The particular apparatus shown has been designed for treating spinal injuries but may be used to apply an electromagnetic field to the whole of a patient's body, for other types of treatment. A bed of suitable non-metallic material is indicated at 42 and an array 44 of helical coils is disposed below the bed and has connections 46 to a suitable pulse train generator (not shown). The individual coils of the array 44 are denoted 48 and it will be seen that the coils are disposed with their axes generally normal to the patient (who will be supported on the bed) and connected in parallel for providing a localized electromagnetic field effect. Connecting the coils in parallel reduces resistance and inductance, which is important for pulse fidelity. The pulse retains its high/low frequency components while making it more effective for therapeutic use.

Figs. 7 and 8 show a cylindrical form of electromagnetic treatment apparatus 50 defining an open central space or cavity 52 within a surrounding sleeve 53. The apparatus can be sized as appropriate in terms of length and diameter to receive the whole of a patient's body or a particular part such as an arm, leg or the neck, depending on the area to be treated.

Preferably, the coil configuration is as shown in Fig. 7, namely an array of coils 55 extending radially with respect to the longitudinal axis of the cylindrical apparatus. Preferably, the coils in each array are connected in parallel to produce a concentrated localized field effect. A series of such coil arrays may be provided in parallel planes based along the length of the cylinder, according to the required overall length of the apparatus, and the desired treatment locations.

In referring to Fig. 7. it should be noted that the coil configuration shown is suitable for providing an electromagnetic field around a container containing blood or other liquid to be treated, for example, a container of the form shown in any of Figs. 1 to 4.

Fig. 9 illustrates the fact that the coils in an array such as that shown in Fig. 7 can be energized by the drive input 53 as independent series of coil pairs in which the pairs of coils are diametrically opposed to one another. Four coils 57a. 57b. 57c and 57d at one side of the Figure are thus connected via conductor ring 59 to one side of the 11 drive input 53; while coils 61a, 61 b. 61c and 61d are connected via conductor ring 63 to the other side of drive input 53. Fig. 9 shows the major flux lines between the coils in each pair, while Fig. 10 shows the full pattern of flux lines.

Fig. 1 1 shows the flux line configuration in which the coils are energized alternately in pairs. Finally, Figs. 12 and 13 show a still further arrangement in which the coils are connected in a cross-field configuration; the flux lines are shown in Fig. 12.

It should be understood that the coil configuration will be chosen according to the nature of the treatment required. For example, in some situations, it may be desired to provide a very localized, concentrated magnetic effect, whereas in other situations, a more diffuse or general effect may be desired.

Fig. 14 .and 15 illustrates a particular coil configuration in which multiple concentric coils are used and in which the ability is provided to switch individual coils in and out of the circuit to change the field strength of the apparatus as a whole. As seen in Fig. 14, four helical coils are shown, although the number of coils may vary. The coils are wound in close proximity to each other and spaced apart as individual coils having the same time/phase relationship so that the summation of all coil sets yields maximum field strength when energized. This coil design feature ensures that the inductance, capacitance and resistance of the coils are kept low so as to produce a faithful reproduction of the energizing pulse wave form. In other words, the driving pulse wave form retains all of its high and low frequency characteristics.

Each of the coils is driven separately by an individual power amplifier but the coils are synchronized. By way of example, each coil may be of 250 turns and be driven at 2.5 amps RMS pulse power. The total electromagnetic field strength at the center of the coils may be about 412 Gauss. It should again be noted that an advantage of this particular coil design is the ability to switch individual coils in and out of the circuit to change the field strength.

Preferably, the individual coils are shielded to minimize the effects of radiated electric field while retaining a faithful reproduction of the electromagnetic pulse.

Fig. 16 shows a thin copper foil shield 54 which surrounds one of the coils except for an open end 54a, and which is grounded at 56.

The electromagnetically pulsed coils are designed and connected in the circuit such that individual coils or coil pairs can be switched in or out of the circuit and driven by separate pulse driving amplifiers. This facilitates flexibility in changing electromagnetic field strength and field position.

Fig. 14 shows four separate coils that can be switched in or out of the circuit separately or switched in the circuit altogether, for example by a switching arrangement such as that shown in Fig. 18.

Fig. 12 shows a circuit of separately connected coil pairs which can be alternatively switched in pairs or switched in circuit altogether, for example by a switching arrangement such as that shown in Fig. 17.

Figs. 19 and 20 simply illustrate conventional electromagnetic field patterns for "additive" and "opposing" coils respectively.

The precise mechanisms responsible for the salutary effects yielded by the invention are at present only partially understood. It is hypothesized, for example, that low frequency pulsating electromagnetic fields may influence magnetic multiple moments of iron bearing molecules such as the components ol red blood cells. One of these components, hemoglobin, is of particular significance, and is the substance within red blood cells that carries oxygen. Each red blood cell has some 270 million hemoglobin molecules and is an agglomeration of four wound-up chains, each of which encloses an iron atom capable of retaining one oxygen molecule. When fully loaded, one hemoglobin molecule can carry four molecules of oxygen -- one blood cell more than one billion molecules. Whole blood when subjected to the influence of a pulsed electromagnetic field of predetermined duration, frequency and flux density, will respond at the cell molecular level by the initiation and production of magnetic interactive energy that will effect covalent molecular structures or electrostatic bonds between molecules. This includes orientational energy that may cause steric alteration within molecules located at cell surfaces, effecting changes in the permeability of ion channels. This could be of particular significance with respect to the reaction mechanism of ozone with blood.

While the present invention has been described in terms of specific embodiments thereof, it will be understood in view of the present disclosure, that numerous variations upon the invention are now enabled to those skilled in the art. which variations yet reside within the scope of the present teaching. Accordingly, the invention is to be broadly construed, and limited only by the scope and spirit of the claims now appended hereto.

Claims

WHAT IS CLAIMED:

1. The synergistic use for enhancing a treatment process carried out on a biological fluid, of a pulsed electromagnetic field applied to the fluid at the same time as the said process.

2. The synergistic use as claimed in claim 1 , wherein the treatment process is a conventional process selected from the group comprising treatment with an ozone or an ozone/oxygen gas mixture and treatment with a drug.

3. The synergistic use as claimed in claim 1 , wherein the biological fluid is selected from the group consisting of blood, blood products, seminal fluids and bone marrow.

4. The synergistic use as claimed in claim 1. wherein the said treatment process and the application of an electromagnetic field are performed when the fluid is external to a human or animal body from which it is derived.

5. An apparatus for use in the treatment of biological fluid, comprising a container for the said fluid, having at least an inlet and an outlet, and means for applying a pulsed electromagnetic field to fluid in said container, said means comprising at least one electromagnetic coil disposed externally of the container and arranged, when energized, to apply an electromagnetic field to fluid in the container.

6. A method in accordance with claim 5. wherein said fluid is provided within said container in the form of a fine spray of droplets which are intermixed with ozone.

7. An apparatus as claimed in claim 5, wherein said at least one coil has a generally cylindrical overall configuration, with a space at the center of the coil for removably receiving the said container.

8. An apparatus as claimed in claim 7, wherein a plurality of said coils are arranged concentrically around the container and are adapted to be selectively energized to provide different electromagnetic field strengths.

9. An apparatus as claimed in claim 5. wherein said means for applying an electromagnetic field to fluid in the container comprises an array of electromagnetic coils arranged in a configuration extending generally radially with respect to a longitudinal axis of the container.

10. An apparatus as claimed in claim 9, wherein said coils are arranged and adapted to be energized as diametrically opposed pairs of coils.

1 1. An apparatus as claimed in claim 9, wherein said coils are arranged and adapted to be energized as adjacent pairs in the array.

12. An apparatus as claimed in claim 5. wherein said biological fluid is to be treated with a gas including at least one of ozone and oxygen, the fluid container being arranged to contain a body of the said fluid, and wherein the container further comprises means for delivering said gas to the fluid in the form of bubbles at a plurality of locations at different vertical heights in said body, and wherein the container is provided, above each said location, with a separator plate provided with perforations selected to permit fluid flow through the plate while trapping said bubbles as a layer on the underside of the plate.

13. Apparatus for applying a pulsed electromagnetic field to a human or animal body fluid in vivo, while the patient is undergoing a treatment process comprising administering to the patient a gas and/or a drug, the apparatus comprising a patient support which is permeable to electromagnetic radiation, and an array of coils disposed below the support and energizable to apply an electromagnetic field to the patient.

14. An apparatus as claimed in claim 13, wherein said array comprises a plurality of electromagnetic coils extending about respective axes disposed generally normal to said patient support and in which the coils are connected in parallel.

15. Apparatus for applying a pulsed electromagnetic field to a human or animal body fluid in vivo, while the patient is undergoing a treatment process comprising administering to the patient a gas and/or a drug, the apparatus comprising means defining a generally cylindrical space for receiving the body or a limb or part of the body of a patient, and means comprising at least one electromagnetic coil for applying an electromagnetic field to the body, component or part of a patient within that space.

16. An apparatus as claimed in claim 15, wherein said at least one coil has a generally cylindrical overall configuration, with a space at the center of the coil for receiving the said body, component or part of a patient.

17. An apparatus as claimed in claim 16. wherein a plurality of said coils are arranged concentrically around the container and are adapted to be selectively energized to provide different electromagnetic field strengths.

18. An apparatus as claimed in claim 5. wherein said means for applying an electromagnetic field to fluid in the container comprises an array of electromagnetic coils arranged in a configuration extending generally radially with respect to a longitudinal axis of said space.

19. An apparatus as claimed in claim 9. wherein said coils are arranged and adapted to be energized as diametrically opposed pairs of coils.

20. An apparatus as claimed in claim 9. wherein said coils are arranged and adapted to be energized as adjacent pairs in the array.