METHOD OF TREATING THE BLOOD

Abstract

A method of stimulating human blood external of a patient donor has the steps of activating an acoustic shock wave or pressure pulse generator to emit acoustic shock waves or pressure pulses directed to impinge the blood, subjecting the blood to the acoustic shock waves or pressure pulses to form stimulated blood cells and transfusing the stimulated blood cells into the patient donor. The patient donor is infected with a virus and the blood exhibits at least traces of the virus. The emitted acoustic shock waves or pressure pulses stimulating the stimulated blood cells fragment the virus in the blood. The fragmented virus in the blood transfused back into the patient donor triggers a defensive immune response to kill the virus. The emitted acoustic shock waves or pressure pulses are preferably of a low energy. The emitted shock waves or pressure pulses stimulate the blood cells and fragment the virus in the absence of cell damaging cavitation due to an elasticity in the blood cells and a lack of elasticity in the virus. The blood is not filtered. The blood can be oxygenated via Extracorporeal membrane oxygenation (ECMO) after being stimulated.

Claims

1. A method of stimulating human blood external of a patient donor comprises the steps of: activating an acoustic shock wave or pressure pulse generator to emit acoustic shock waves or pressure pulses directed to impinge the blood; subjecting the blood to the acoustic shock waves or pressure pulses to form stimulated blood cells; and transfusing the stimulated blood cells into the patient donor.

2. The method of claim 1 wherein the patient donor is infected with a virus and the blood exhibits at least traces of the virus.

3. The method of claim 2 wherein the emitted acoustic shock waves or pressure pulses stimulating the stimulated blood cells fragment the virus in the blood.

4. The method of claim 3 wherein the fragmented virus in the blood transfused back into the patient donor triggers a defensive immune response to kill the virus.

5. The method of claim 1 wherein the emitted acoustic shock waves or pressure pulses are of a low energy.

6. The method of claim 1 wherein the emitted shock waves or pressure pulses stimulate the blood cells and fragment the virus in the absence of cell damaging cavitation due to an elasticity in the blood cells and a lack of elasticity in the virus.

7. The method of claim 1 wherein the blood is not filtered.

8. The method of claim 1 wherein the blood can be oxygenated via Extracorporeal membrane oxygenation (ECMO) after being stimulated.

9. A composition of transfusable blood comprises: a quantity of blood for transfusions; and a plurality of fragmented viruses fragmented by acoustic shock waves or pressure pulses dispersed in the quantity of blood.

10. The composition of claim 9 wherein the plurality of fragmented viruses when transfused into a virus infected patient activates a defensive immune response to kill the virus in the transfused patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The invention will be described by way of example and with reference to the accompanying drawings in which:

[0049] FIG. 1 is a simplified depiction of a pressure pulse/shock wave (PP/SW) generator with focusing wave characteristics.

[0050] FIG. 2 is a simplified depiction of a pressure pulse/shock wave generator with plane wave characteristics.

[0051] FIG. 3 is a simplified depiction of a pressure pulse/shock wave generator with divergent wave characteristics.

[0052] FIG. 4 is a simplified depiction of a pressure pulse/shock wave generator being connected to a control/power supply unit.

[0053] FIG. 5 shows an exemplary pressure pulse/shock wave generator device.

[0054] FIG. 5A shows an exemplary pressure pulse/shock wave generator device contacting a bag or container or tube of blood.

[0055] FIG. 6 shows a blood treatment device by way of example a dialysis device that can be used with a pressure pulse/shock wave generator device.

[0056] FIG. 7 shows an Extracorporeal membrane oxygenation (ECMO) device that can be used with a pressure pulse/shock wave generator device.

DETAILED DESCRIPTION OF THE INVENTION

[0057] The goal in such treatments is to provide 100 to 3000 acoustic shock waves or pressure pulses at a voltage of 5 kV to 28 kV across a spark gap generator, electromagnetic, piezoelectric or a ballistic wave generator in a single treatment preferably or one or more adjuvant treatments by impinging the emitted waves on the blood.

[0058] The unfocused shock waves or pressure pulses can be of a divergent wave pattern or near planar pattern preferably of a low peak pressure amplitude and density. Typically, the energy density values of the shock waves range as low as 0.000001 mJ/mm.sup.2 and having a high-end energy density of below 1.0 mJ/mm.sup.2, preferably 0.40 mJ/mm.sup.2 or less, more preferably 0.20 mJ/mm2 or less. The peak pressure amplitude of the positive part of the cycle should be in the rage of nano-second up to some milliseconds and its duration is below 1-3 microseconds.

[0059] The pressure pulse is much slower, a “pressure pulse” according to the present invention is an acoustic pulse which includes several cycles of positive and negative pressure. The amplitude of the positive part of such a cycle should be above about 0.1 MPa and its time duration is from below a microsecond to about a second. Rise times of the positive part of the first pressure cycle may be in the range of nano-seconds (ns) up to some milli-seconds (ms).

[0060] These shock wave energy transmissions are effective in stimulating a cellular response and can be accomplished without creating the cavitation bubbles in the blood. The underlying principle of these shock wave therapy methods is to stimulate the body's own natural healing capability by transfusing stimulated blood cells into an ill or infected patient.

[0061] The following invention description first provides a detailed explanation of acoustic shock waves or pressure pulses, as illustrated in FIGS. 1-4. As used herein an acoustic shock wave is an asymmetric wave with an exceptionally rapid peak rise time and slower return time from the peak amplitude. Historically, these acoustic shock waves or pressure pulses were first used medically to destroy kidney stones. The wave patterns were directed to a focal point with a relatively high energy to blast the concrements into small urinary tract passable fragments.

[0062] A whole class of acoustic shock waves or pressure pulses for medical treatments were later discovered that employed low energy acoustic shock waves or pressure pulses. These low energy acoustic shock waves or pressure pulses maintained the asymmetric wave profile, but at much lower energies as described in US2006/0100550 which is incorporated herein in its entirety.

[0063] These low energy acoustic shock waves or pressure pulses advantageously could stimulate blood without requiring a focused beam. The advantage of such an unfocused beam was the acoustic wave could be directed to pass through a container or tubing filled with blood without causing any cell rupturing which would be evidenced by a lack of cell membrane damage. This use of unfocused, low energy acoustic shock waves or pressure pulses provided an ability to treat a large volume of blood.

[0064] The use of low energy acoustic shock waves or pressure pulses that employ a focused beam has been spurred on as a viable alternative to the unfocused low energy shock waves because the focal point being of a small point of energy has little or a small region of cell damage as the remaining portions of the wave pattern can provide a stimulating effect similar to the unfocused shock waves. Basically, the effect is the same with the users of focused waves achieving the benefits of the unfocused waves, but with a focal point of peak energy in a tiny localised region. So, for purposes of the present invention, the use of “soft waves” those defined by low energy beams will be applicable to both focused and unfocused beams of acoustic shock waves or pressure pulses for the present invention.

[0065] One last and significant point that the reader must appreciate is that an “acoustic shock wave” is not an “ultrasound wave”. Sonic or ultrasound waves are generated with a uniform and symmetrical wave pattern similar to a sinusoidal wave. This type of sonic wave causes a sheer action on tissue as evidenced by a generation of heat within the tissue or blood, for this reason, the use of sonic waves of the ultrasonic type are not considered as efficient in cell survivability rates. The present invention provides an apparatus for an effective treatment of indications, which benefit from high or low energy pressure pulse/shock waves having focused or unfocused, nearly plane, convergent or even divergent characteristics. With an unfocused wave having nearly plane, plane, convergent wave characteristic or even divergent wave characteristics, the energy density of the wave may be or may be adjusted to be so low that side effects including pain are very minor or even do not exist at all.

[0066] In certain embodiments, the apparatus of the present invention is able to produce waves having energy density values that are below 0.1 mJ/mm.sup.2 or even as low as 0.000 001 mJ/mm.sup.2. In a preferred embodiment, those low-end values range between 0.1-0.001 mJ/mm.sup.2. With these low energy densities, side effects are reduced, and the dose application is much more uniform. The apparatus of the present invention also may allow the user to make more precise energy density adjustments than an apparatus generating only focused shock waves, which is generally limited in terms of lowering the energy output.

[0067] The present invention relates to the use of various therapeutic pressure pulse wave patterns or acoustic shock wave patterns as illustrated in FIGS. 1-3 for treating the blood of infected donors and using the treated blood for direct transfusion back into the infected donor or if properly blood type matched into another patient. Each illustrated wave pattern will be discussed later in the description; however, the use of each has particularly interesting beneficial features that are a remarkably valuable new tool in the fight against such viruses.

[0068] With reference to FIGS. 1-3, a variety of schematic views of acoustic shock waves or pressure pulses are described. The following description of the proper amplitude and pressure pulse intensities of the shock waves are provided along with a description of how the shock waves actually function. For the purpose of describing, the shock waves were used as exemplary and are intended to include all of the wave patterns discussed in the figures as possible treatment patterns.

[0069] FIG. 1 is a simplified depiction of a pressure pulse/shock wave (PP/SW) generator, such as a shock wave head, showing focusing characteristics of transmitted acoustic pressure pulses. Numeral 1 indicates the position of a generalized pressure pulse generator, which generates the pressure pulse and, via a focusing element, focuses it outside the housing to treat diseases. The affected blood is generally located in or near the focal point which is located in or near position 6. At position 17 a water cushion or any other kind of exit window for the acoustical energy is located.

[0070] FIG. 2 is a simplified depiction of a pressure pulse/shock wave generator, such as a shock wave head, with plane wave characteristics. Numeral 1 indicates the position of a pressure pulse generator according to the present invention, which generates a pressure pulse which is leaving the housing at the position 17, which may be a water cushion or any other kind of exit window. Somewhat even (also referred to herein as “disturbed”) wave characteristics can be generated, in case a paraboloid is used as a reflecting element, with a point source (e.g. electrode) that is located in the focal point of the paraboloid. The waves will be transmitted into a bag or container of blood via a coupling media such as, e.g., ultrasound gel or oil and their amplitudes will be attenuated with increasing distance from the exit window 17.

[0071] FIG. 3 is a simplified depiction of a pressure pulse shock wave generator (shock wave head) with divergent wave characteristics. The divergent wave fronts may be leaving the exit window 17 at point 11 where the amplitude of the wave front is very high. This point 17 could be regarded as the source point for the pressure pulses. In FIG. 3 the pressure pulse source may be a point source, that is, the pressure pulse may be generated by an electrical discharge of an electrode under water between electrode tips. However, the pressure pulse may also be generated, for example, by an explosion, referred to as a ballistic pressure pulse. The divergent characteristics of the wave front may be a consequence of the mechanical setup.

[0072] This apparatus, in certain embodiments, may be adjusted/modified/or the complete shock wave head or part of it may be exchanged so that the desired and/or optimal acoustic profile such as one having wave fronts with focused, planar, nearly plane, convergent or divergent characteristics can be chosen.

[0073] A change of the wave front characteristics may, for example, be achieved by changing the distance of the exit acoustic window relative to the reflector, by changing the reflector geometry, by introducing certain lenses or by removing elements such as lenses that modify the waves produced by a pressure pulse/shock wave generating element. Exemplary pressure pulse/shock wave sources that can, for example, be exchanged for each other to allow an apparatus to generate waves having different wave front characteristics are described in detail below.

[0074] In one embodiment, mechanical elements that are exchanged to achieve a change in wave front characteristics include the primary pressure pulse generating element, the focusing element, the reflecting element, the housing and the membrane. In another embodiment, the mechanical elements further include a closed fluid volume within the housing in which the pressure pulse is formed and transmitted through the exit window.

[0075] In one embodiment, the apparatus of the present invention is used in combinations of shock wave therapies. Here, the characteristics of waves emitted by the apparatus are switched from, for example, focused to divergent or from divergent with lower energy density to divergent with higher energy density. Thus, effects of a pressure pulse treatment can be optimized by using waves having different characteristics and/or energy densities, respectively.

[0076] While the above described universal toolbox of the various types of acoustic shock waves or pressure pulses and types of shock wave generating heads provides versatility, the person skilled in the art will appreciate that apparatuses that produce low energy or soft acoustic shock waves or pressure pulses having, for one example, nearly plane characteristics, are less mechanically demanding and fulfill the requirements of many users.

[0077] As the person skilled in the art will also appreciate that embodiments shown in the drawings are independent of the generation principle and thus are valid for not only electro-hydraulic shock wave generation but also for, but not limited to, PP/SW generation based on electromagnetic, piezoceramic and ballistic principles. The pressure pulse generators may, in certain embodiments, be equipped with a water cushion that houses water which defines the path of pressure pulse waves that is, through which those waves are transmitted. In a preferred embodiment, a container or tubing filled with blood is coupled via ultrasound gel or oil to the acoustic exit window (17), which can, for example, be an acoustic transparent membrane, a water cushion, a plastic plate or a metal plate.

[0078] FIG. 5 shows an exemplary shock wave device generator or source 1 with a control and power supply 41 connected to a hand-held applicator shock wave head 43 via a flexible hose 42 with fluid conduits. The illustrated shock wave applicator 43 has a flexible membrane at an end of the applicator 43 which transmits the acoustic waves when coupled to the skin by using a fluid or acoustic gel. As shown, this type of applicator 43 has a hydraulic spark generator using either focused or unfocused shock waves, preferably in a low energy level, less than the range of 0.01 mJ/mm.sup.2 to 0.3 mJ/mm.sup.2. The flexible hose 42 is connected to a fluid supply that fills the applicator 43 and expands the flexible membrane when filled. Alternatively, a ballistic, piezoelectric or spherical acoustic shock wave device can be used to generate the desired waves.

[0079] FIG. 5A shows the applicator 43 emitting waves 200 into a container 202 of blood 100.

[0080] FIG. 6 shows a blood treatment device by way of example a dialysis device that can be used with a pressure pulse/shock wave generator device treating the blood as it passes through the tubing.

[0081] With reference to FIG. 7, a perspective view of an ECMO device is shown that can be used with a pressure pulse or shock wave generator device.

[0082] A shock wave applicator head 43 is brought into contact with the container or tube of blood 100 preferably an acoustic gel is used to enhance the transmission of the shock waves 200 through the blood 100. The shock wave applicator head 43 is connected via cabling 42 to a power generating unit 41 as shown. The shock wave applicator head 43 can be attached rigidly to a fixture or stand or alternatively can be hand held and manipulated across the blood to drive the shock waves 200 in the direction the shock wave head 43 is pointed to activate a response.

[0083] Shock waves are a completely different technology and a quantum leap beyond other forms of treatments. The mechanism of shock waves is far from being understood, but is known to cause new blood vessels to grow in an area of treatment and regenerate bony tissue. In the present invention shock waves are used to treat patients with a virus or blood disease. This is a phenomenal advancement in the current approach.

[0084] The present invention employs the use of pressure pulses or shock waves to stimulate blood.

[0085] The transmission dosage can be from a few seconds to 20 minutes or more dependent on the condition. Preferably the waves are generated from an unfocused or focused source. The unfocused waves can be divergent, planar or near planar and having a low pressure amplitude and density in the range of 0.00001 mJ/mm.sup.2 to 1.0 mJ/mm.sup.2 or less, most typically below 0.2 mJ/mm.sup.2. The focused source preferably can use a diffusing lens or have a far-sight focus to minimize if not eliminate having the localized focus point within the tissue. Preferably the focused shock waves are used at a similarly effective low energy transmission or alternatively can be at higher energy but wherein the target site is disposed pre-convergence inward of the geometric focal point of the emitted wave transmission. This emitted energy preferably stimulates the blood cells with minimal rupturing of cellular membranes. The surrounding healthy blood cells in the region treated are activated and the virus is fragmented so upon transfusion an immune defence mechanism response is initiated.

[0086] As illustrated, the device shown is an electrohydraulic acoustic shock wave generator, however, other devices that generate acoustic shock waves or pressure pulses can be used. Ultrasonic devices may be considered, but there is no data to support a sinusoidal wave form would work and therefore not considered as effective as the asymmetric wave generators. The acoustic shock waves or pressure pulses activate a cellular response within the blood. This response or stimulation causes an increase of nitric oxide and a release of a variety of growth factors such as VEGF and a release of anti-microbial peptides like LL37. As shown, the flexible membrane is protruding outward and the applicator 43 has been filled with fluid, the transmission or emission of acoustic shock waves or pressure pulses 200 is directed towards the blood 100. It is believed that a single treatment of the blood 100 will achieve the desired effect. However, repeated treatments may be administered.

[0087] These shock wave energy transmissions are effective in stimulating a cellular response and can be accomplished without creating excessive cavitation bubbles in the blood when employed in other than site targeted high energy focused transmissions. This effectively ensures the blood cells do not have to experience the sensation of tearing or of excessive hemorrhaging so common in the use of higher energy focused wave forms having a focal point at or within the targeted treatment site.

[0088] Due to the wide range of beneficial treatments available it is believed preferable that the optimal use of one or more wave generators or sources should be selected on the basis of the specific application. Wherein relatively small target sites may involve a single wave generator placed on an adjustable manipulator arm. A key advantage of the present inventive methodology is that it is complimentary to conventional medical procedures.

[0089] The underlying principle of these pressure pulse or shock wave therapy methods is to enrich the blood directly while fragmenting the virus creating an effective vaccine effect. This is particularly useful in containing asymptomatic patients who carry the virus and to stimulate the body's own natural healing capability. The acoustic shock waves transmit or trigger what appears to be a cellular communication throughout the entire anatomical structure, this activates a generalized cellular response at the blood, in particular, but more interestingly a systemic response in areas more removed from the wave form pattern. This is believed to be one of the reasons molecular stimulation can be conducted at threshold energies heretofore believed to be well below those commonly accepted as required. Accordingly, not only can the energy intensity be reduced in some cases, but also the number of applied shock wave impulses can be lowered from several thousand to as few as one or more pulses and still yield a beneficial stimulating response. The key is to provide at least a sufficient amount of energy to activate healing reactions and fragment the virus in the blood.

[0090] Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described which will be within the full intended scope of the invention as defined by the following appended claims.