WO2006047082A2

WO2006047082A2 - Pressure pulse/shock wave therapy methods and an apparatus for conducting the therapeutic methods

Info

Publication number: WO2006047082A2
Application number: PCT/US2005/036455
Authority: WO
Inventors: Reiner Schultheiss; Wolfgang Schaden; John Warlick; Michael Grimm; Robert Schmidhammer; Robert Goeschl
Original assignee: General Patent, Llc
Priority date: 2004-10-22
Filing date: 2005-10-12
Publication date: 2006-05-04
Also published as: WO2006047082A3; WO2006047082A8

Abstract

The method of stimulating a substance is disclosed. The method has the steps of activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the substance to the acoustic shock waves stimulating said substance wherein the substance is positioned within a path of the emitted shock waves and away from a geometric focal volume or point of the emitted shock waves. In some of the methods, the emitted shock waves may be divergent or near planar, or the emitted shock waves are convergent having a geometric focal volume of point at a distance of at least X from the source, the method further comprising positioning the substance at a distance less than the distance X from the source.

Description

PRESSURE PULSE/SHOCK WAVE THERAPY METHODS AND AN APPARATUS FOR CONDUCTING

THE THERAPEUTIC METHODS

Field of the Invention

[0001] This invention relates to the field of treating mammals with acoustic pressure pulse shock waves generally. More specifically to treating various conditions found in humans and animals using shock waves that are generated as either focused waves at high or low energy levels or non-focused waves at preferably low energy levels or a combination of such waves.

Background of the Invention

[0002] In certain non-urological applications, focused shock waves are used to treat ischemic heart tissue for generating better blood supply by targeting the treated tissue in the focal point of the emitted wave pattern and thus recovering the tissue's functionality as is shown in patent publication US 2002/0002345. A primary advantage of shock wave treatments has been they can be conducted non-invasively and extracorporeal. However such treatments are diminished by the surrounding and overlying tissue and skeletal structures. In patent publication US2002/0002345 of Jan 3,2002 the inventor. Earnest H. Marlinghaus suggested using focused shock waves in an extracorporeal arrangement for transmission through bone open spaces between adjacent ribs for revascularization of the heart.

[0003] Drawbacks of such treatments are the loss of range for directing the Shockwaves and the remoteness of the Shockwave generating source from the targeted organ. This is further complicated by the use of focused convergent shock waves which rely on a localized focal volume or point to provide the desired therapeutic affect. [0004] C. J. Wang discovered that a variety of substances displaying high biological activity are released during and after the application of shock waves to tissue. The production of nitric oxygen (NO), vessel endothelial growth factor (VEGF), bone morphogenetic protein (BMP), and other growth factors have been demonstrated. Furthermore, Maier discovered a decline in the number of small-myelinized neurons after shock wave therapy, an observation that could explain the analgesic effect of shock wave therapy. As a consequence of these findings, the mechanistic model was increasingly relegated to a secondary role and supplanted by a microbiological model explaining the action of shock waves.

[0005] In practice the use of Extracorporeal Shock Wave Therapy (ESWT) has been a results oriented science wherein a clear and accurate understanding of the actual healing process was neither understood nor fully appreciated. As a result a variety of treatments and uses of ESWT in mammals had heretofore never been tried or attempted or if tried, the outcomes were at best mixed.

[0006] A primary factor in the reluctance to use ESWT was that the believed threshold energy requirements were so high that the surrounding tissue would hemorrhage, exhibited by hematomas and bleeding around the treated site. This phenomenon is particularly known in the area of focused emitted waves designed for deep penetration into the patient. US patent publication 2005/0010140 recites the disadvantageous effects of cavitation phenomena can be controlled wherein the shock wave source is connected to a control means which controls the release frequency of shock waves as a function of pulse energy in such a manner that higher pulse energy correlates with lower release frequencies of the shock waves and vice versa. The avoidance of cavitation occurrences would it is postulated result in far less pain for the patient. [0007] The present invention recognizes the underlying beneficial attributes of ESWT are not now and may never be fully comprehended however, under a more advanced molecular theory the authors of the present invention postulated a microbiological model suggesting the response mechanism to such treatment

[0008] It is an object therefore of the present invention to provide a shock wave therapy that employs a more effective wave energy transmission, that is both simple to deploy and less target sensitive when compared to reflected focused waves

[0009] These and other applications of the piesent invention are described more fully as follows with first detailed description of shock wave therapeutic methods and then a detailed description ot several shock wave devices and appaiati for cairying out the methods

Summary of the Invention

[0010] While the advantages of non invasive treatments are tremendous the present invention in one embodiment discloses a novel and complimentary method of using acoustic shock wave treatments on organs directly wherein the organ is removed from the patients body as is the case in transplants or while the organ is exposed due to a surgical procedure permitting a direct transmission ot the acoustic waves without interfering tissue or skeletal bone mass The direct benefits of such a novel use of shock waves are faster healing time, improved tissue regeneration, germicidal cleanliness, potentially complete peripheral access to the organ and revascularization In the case of heart treatments the inventive method minimizes fi agile lung membranes exposure to errant Shockwaves [001 1 ] These benefits are particularly useful in open heart surgery for treating a heart, in treating a liver, a kidney or a brain Each of these organs is a soft tissue mass ot high percentage fluid volume making transmission of the emitted shock waves quite easy when interfering features such as tissue or bone are avoided [0012] The method of stimulating an organ comprises the steps of providing an at least partially exposed or direct access portal to an organ, activating an acoustic shock wave generator or source to emit acoustic shock waves, and subjecting the organ to the acoustic shock waves stimulating said organ wherein the organ is positioned within an unobstructed path of the emitted shock waves In one embodiment the emitted shock waves are divergent or near planar In another embodiment the emitted shock waves are convergent having a geometric focal volume or focal point at a distance of at least X from the source, the method further comprising positioning the organ at a distance at or less than the distance X from the source The organ is a tissue having cells The tissue can be an organ of a mammal The mammal may be a human or an animal The organ may be a heart, a brain, a liver or a kidney or any other organ The tissue may be a part of the vascular system, a part of the nervous system, a part of the urinary or reproductive system

[0013] The method of stimulating an organ can further include a result wherein the step of subjecting the organ to acoustic shock waves stimulates at least some of said cells within said organ to release or produce one or more of nitric oxygen (NO), vessel endothelial growth factor (VEGF), bone morphogenetic protein (BMP) or other growth factors

[0014] The organ can be a tissue having a pathological condition, a tissue having been subjected to a prior trauma, a tissue having been subjected to an opeiative procedure, or a tissue in a degenerative condition The organ is at least partially surgically exposed if not removed from the patient during the exposure to an unobstructed shock wave treatment [0015] In yet another embodiment the use of shock waves includes a method of preventive shock wave therapy having the steps of: identifying an at risk patient having an at risk tissue; and subjecting the at risk tissue to shock waves to stimulate tissue repair. The step of identifying an at risk patient includes one or more indications of risk based on family history, genetic disposition, physical condition, or blood or tissue analysis. The method of preventive shock wave therapy further may have the step of testing the at risk tissue to establish measured baseline condition pre shock wave therapy and the step of post shock wave therapy testing the treated tissue for comparison to the baseline condition. This method includes treating a patient immediately or very soon after being stabilized from a cardiac infarction or heart attack. In such a case the procedural treatment may be conducted invasively or non-invasively dependent on the patient's condition which may or may not require a surgical procedure to expose at least a portion of the heart.

[0016] In each of these therapeutic methods or treatments using shock waves, the use or treatment may additionally include the use or administration of one or more antibiotics, drugs, chemicals, or other medical treatments to the blood stream stimulated by acoustic shock waves. The overall combination resulting in a reduced healing response time stimulated by the use of acoustic shock waves. In particular the antibiotics or other drugs that are introduced to the blood stream are beneficially assisted by the improved blood supply resulting from being stimulated by these acoustic shock waves. This means the drugs can work faster and be more efficient. The use of such acoustic waves in combination with antibiotics or other drugs means less potent or even lower dosages can be used in most treatments thereby lowering the risk of complications such as liver damage or the like. [0017] Alternative embodiments are further disclosed wherein extracorporeal shock wave treatments are applied to treat chemical / radiation exposures, to destroy biofilms and periodontal biofilms, repair nerve or neural damage, stimulate plant growth or aquatic life form growth. In some of the methods convergent, focused shock waves of high energy are employed in combination with low energy wave patterns to destroy masses, tumors or biomasses. A novel apparatus for providing the shock waves is also disclosed.

Definitions

[0018] A "curved emitter" is an emitter having a curved reflecting (or focusing) or emitting surface and includes, but is not limited to, emitters having ellipsoidal, parabolic, quasi parabolic (general paraboloid) or spherical reflector/reflecting or emitting elements. Curved emitters having a curved reflecting or focusing element generally produce waves having focused wave fronts, while curved emitters having a curved emitting surfaces generally produce wave having divergent wave fronts.

[0019] "Divergent waves" in the context of the present invention are all waves which are not focused and are not plane or nearly plane. Divergent waves also include waves which only seem to have a focus or source from which the waves are transmitted. The wave fronts of divergent waves have divergent characteristics. Divergent waves can be created in many different ways, for example: A focused wave will become divergent once it has passed through the focal point. Spherical waves are also included in this definition of divergent waves and have wave fronts with divergent characteristics.

[0020] "extracorporeal" occurring or based outside the living body.

[0021] A "generalized paraboloid" according to the present invention is also a three-dimensional bowl. In two dimensions (in Cartesian coordinates, x and y) the formula y"=2px [with n being ≠ 2, but being greater than about 1.2 and smaller than 2, or greater than 2 but smaller than about 2.8]. In a generalized paraboloid, the characteristics of the wave fronts created by electrodes located within the generalized paraboloid may be corrected by the selection of (p (-z,+z)), with z being a measure for the burn down of an electrode, and n, so that phenomena including, but not limited to, burn down of the tip of an electrode (-z,+z) and/or disturbances caused by diffraction at the aperture of the paraboloid are compensated for.

[0022] A "paraboloid" according to the present invention is a three-dimensional reflecting bowl. In two dimensions (in Cartesian coordinates, x and y) the formula y²=2px, wherein p/2 is the distance of the focal point of the paraboloid from its apex, defines the paraboloid. Rotation of the two-dimensional figure defined by this formula around its longitudinal axis generates a de facto paraboloid.

[0023] "Plane waves" are sometimes also called flat or even waves. Their wave fronts have plane characteristics (also called even or parallel characteristics). The amplitude in a wave front is constant and the "curvature" is flat (that is why these waves are sometimes called flat waves). Plane waves do not have a focus to which their fronts move (focused) or from which the fronts are emitted (divergent). "Nearly plane waves" also do not have a focus to which their fronts move (focused) or from which the fronts are emitted (divergent). The amplitude of their wa^ve fronts (having "nearly plane" characteristics) is approximating the constancy of plain waves. "Nearly plane" waves can be emitted by generators having pressure pulse/ shock wave generating elements with flat emitters or curved emitters. Curved emitters may comprise a generalized paraboloid that allows waves having nearly plane characteristics to be emitted.

[0024] 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 IVEPa 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). Very fast pressure pul ses are called shock waves. Shock waves used in medical applications do have amplitudes above 0.1 MPa and rise times of the amplitude are below 100 ns. The duration of a shock wave is typically below 1-3 micro-seconds (μs) for the positive part of a cycle and typically above some micro-seconds for the negative part of a cycle. [0025] Waves/wave fronts described as being "focused" or "having focusing characteristics" means in the context of the present invention that the respective waves or wave fronts are traveling and increase their amplitude in direction of the focal point. Per definition the energy of the wave will be at a maximum in the focal point or, if there is a focal shift in this point, the energy is at a maximum near the geometrical focal point. Both the maximum energy and the maximal pressure amplitude may be used to define the focal point.

Brief Description of the Drawings

[0026] The invention will be described by way of example and with reference to the accompanying drawings in which:

Figure Ia is a simplified depiction of a pressure pulse / shock wave (PP/SW) generator with focusing wave characteristics.

Figure Ib is a simplified depiction of a pressure pulse / shock wave generator with plane wave characteristics.

Figure Ic is a simplified depiction of a pressure pulse / shock wave generator with divergent wave character! sties. Figure 2a is a simplified depiction of a pressure pulse / shock wave generator having an adjustable exit window along the pressure wave path. The exit window is shown in a focusing position.

Figure 2b is a simplified depiction of a pressure pulse / shock wave generator having an exit window along the pressure wave path. The exit window as shown is positioned at the highest energy divergent position.

Figure 2c is a simplified depiction of a pressure pulse / shock wave generator having an exit window along the pressure wave path. The exit window is shown at a low energy divergent position.

Figure 3 is a simplified depiction of an electro-hydraulic pressure pulse / shock wave generator having no reflector or focusing element. Thus, the waves of the generator did not pass through a focusing element prior to exiting it.

Figure 4a is a simplified depiction of a pressure pulse / shock wave generator having a focusing element in the form of an ellipsoid. The waves generated are focused.

Figure 4b is a simplified depiction of a pressure pulse / shock wave generator having a parabolic reflector element and generating waves that are disturbed plane.

Figure 4c is a simplified depiction of a pressure pulse / shock wave generator having a quasi parabolic reflector element (generalized paraboloid) and generating waves that are nearly plane/have nearly plane characteristics.

Figure 4d is a simplified depiction of a generalized paraboloid with better focusing characteristic than a paraboloid in which n=2. The electrode usage is shown. The generalized paraboloid, which is an interpolation (optimization) between two optimized paraboloids for a new electrode and for a used (burned down) electrode is also shown.

Figure 5 is a simplified depiction of a pressure pulse / shock wave generator being connected to a control/power supply unit.

Figure 6 is a simplified depiction of a pressure pulse / shock wave generator comprising a flat EMSE

(electromagnetic shock wave emitter) coil system to generate nearly plane waves as well as an acoustic lens.

Convergent wave fronts are leaving the housing via an exit window.

Figure 7 is a simplified depiction of a pressure pulse / shock wave generator having a flat EMSE coil system to generate nearly plane waves. The generator has no reflecting or focusing element. As a result, the pressure pulse / shock waves are leaving the housing via the exit window unfocused having nearly plane wave characteristics.

Figure 8 is a simplified depiction of a pressure pulse / shock wave generator havin g a flat piezoceramic plate equipped with a single or numerous individual piezoceramic elements to generate plane waves without a reflecting or focusing element. As a result, the pressure pulse / shock waves are leaving the housing via the exit window unfocused having nearly plane wave characteristics.

Figure 9 is a simplified depiction of a pressure pulse / shock wave generator having a cylindrical EMSE system and a triangular shaped reflecting element to generate plane waves. As a result, the pressure pulse / shock waves are leaving the housing via the exit window unfocused having nearly plane wave characteristics.

Figure 10 is a simplified depiction of a pressure pulse / shock wave (PP/SW) generator with focusing wave characteristics shown focused with the focal point or geometrical focal volume being on an organ, the focus being targeted on the location X₀.

Figure 11 is a simplified depiction of a pressure pulse / shock wave (PP/SW) generator with the focusing wave characteristics shown wherein the focus is located a distance X, from the location X₀ of^" an organ wherein the converging waves impinge the organ. Figure 12 is a simplified depiction of a pressure pulse / shock wave (PP/SW) generator with focusing wave characteristics shown wherein the focus is located a distance X₂ from the mass location X₀ wherein the emitted divergent waves impinge the organ.

Figure 13 is a perspective view of a portion of the periodontal region showing the tooth, gurn and biofilm buildup of plaque.

Figure 13a is an enlarged view of the gingival crevice.

Figure 14 shows a patient being treated extracorporeal Iy with shock waves being transmitted through the skin tissue to the periodontal region to be treated.

Figure 15 shows a patient being treated extracorporeally with shock waves being transmitted through the skin and cranial bone tissue to the neurological region to be treated.

Figure 16 is a perspective view of a frontal region of a heart being shock wave treated by a shock wave head according to the method of the present invention.

Figure 17 is a perspective view of the posterior region of a heart being shock wave treated according to the present inventive method.

Figure 18 is a perspective view of a brain being shock wave treated according to the method of the present invention.

Figure 19 is a perspective view of a liver being shock wave treated according to the method of the present invention.

Figure 20 is a perspective view of a pair of kidneys, one of said kidneys being shown treated by shock wave from shock wave head according to the method of the present invention.

Figure 21 shows shock waves being transmitted through a container or vat having a plural ity of plant tissues to be treated or aquatic specimens or aquatic life forms being treated.

Detailed Description of the Invention

[0027] In one embodiment of the present invention the shock wave method of treating an organ of a mammal be it human or an animal with an at least partially exposed target site on the organ, the organ is positioned in a convenient orientation to permit the source of the emitted waves to most directly send the Λvaves unobstructed to the target site to initiate shock wave stimulation of the target area with minimal, preferably no interfering tissue or bone features in the path of the emitting source or lens. Assuming the target area is within a projected area of the wave transmission, a single transmission dosage of wave energy may be used. The transmission dosage can be from a few seconds to 20 minutes or more dependant on the condition. Preferably the waves are generated from an unfocused or focused source. The unfocused waves can be divergent or near planar and having a low pressure amplitude and density in the range of 0.00001 mJ/mm² to 1.0 mJ/mm² or less, most typically below 0.2 mJ/mm². 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 tissue target site is disposed pre- convergence inward of the geometric focal point of the emitted wave transmission. [0028] These shock wave energy transmissions are effective in stimulating a eel IuI ar response and can be accomplished without creating the cavitation bubbles in the tissue of the target site. This effectively insures the organ does not have to experience the sensation of hemorrhaging so common in the higher energy focused wave forms having a focal point at or within the targeted treatment site.

[0029] If the target site is an organ subjected to a surgical procedure exposing at least some if not all of the organ within the body cavity the target site may be such that the patient or the generating source must be reoriented relative to the site and a second, third or more treatment dosage can be administered . The fact that the dosage is at a low energy the common problem of localized hemorrhaging is reduced making it more practical to administer multiple dosages of waves from various orientations to further optimize the treatment and cellular stimulation of the target site. Heretofore focused high energy multiple treatments induced pain and discomfort to the patient. The use of low energy focused or un-focused waves at the target site enables multiple sequential treatments. [0030] The present method does not rely on precise site location per se. The phys ϊcian's general understanding of the anatomy of the patient should be sufficient to locate the target area to be treated . This is particularly true when the exposed organ is visually within the surgeon's line of sight and this permits the lens or cover of the emitting shock wave source to impinge on the organ tissue directly during the Shockwave treatment. The treated area can withstand a far greater number of shock waves based on the selected energy level being emitted. For example at very low energy levels the stimulation exposure can be provided over prolonged periods as much as 20 minutes if so desired. At higher energy levels the treatment duration can be shortened to less than a minute, less than a second if so desired. The limiting factor in the selected treatment dosage is avoidance or minimization of cell hemorrhaging and other kinds of damage to the cells or tissue while still providing a stimulating stem cell activation or a cellular release or activation of VEGF and other growth factors.

[0031] With reference to figures 16 and 17 the organ 100 is shown as a heart. In Pigure 16 a frontal view of the heart is shown wherein the frontal region is being bombarded with exemplary shoctc waves 200 wherein the Shockwave head 43 is shown unobstructed to the tissue of the heart. The Shockwave head 43 is connected through the cable 42 back to a control and power supply 41 , as was shown in figure 5. As i llustrated the exemplary shock waves 200 emanate through the tissue of the heart providing a beneficial regenerati ng and revascularization capability that heretofore was unachieved. The beneficial aspects of the present methodology are that the heart 100 as shown fully exposed in the views figures 16 and 17 can be partially exposed or have an access portal such that the shock wave head 43 can be inserted therein and directed to contact or be in nea.τ contact to the heart tissue is such a way that the admitted exemplary shock waves 200 can most directly and in "the most unobstructed way be transmitted to the region needing treatment. While the use of the shock wave head 43 in this fashion is clearly invasive it also has the beneficial aspects of providing a direct treatment to the cardiovascular area in need of regenerative or revascularization enhancement.

[0032] With reference to Fig 18, the organ 100 is a brain. As shown the brain and brain stem are completely exposed, however, normally only a small portion of the cranial cavity would be op -en such that the Shockwave head 43 can be inserted therein to provide therapeutic shock wave treatments preferably of very low amplitude for stimulating certain regions 300 of the brain for regenerative purposes.

[0033] In Fig 19 a liver 100 is shown. In addition to the liver 100, the stomach 1 03, spleen 104 and duodenum 106 are also shown. The shock wave head 43 is in contact with the liver 100 and ϊ s providing a therapeutic shock wave treatment as illustrated wherein the exemplary shock waves 200 are being transmitted through the tissue of the liver. It is believed that the use of such exemplary shock waves 200 can help in enhancing liver regeneration particularly those that have been degenerative and in conditions that might be prone to failure. Again the liver 100 is shown fully exposed, however, in normal procedure only an access portal or opening may be needed such that the shock wave head 43 can be inserted there through and provide a direct unobstructed path to deliver Shockwave treatments to this organ as well.

[0034] In Fig 20 a pair of kidneys 100 is shown as the organ 100 being treated. In this fashion the kidneys similar to the liver, brain or heart can be treated such that the shock wave head 43 can be in d irect or near contact in an unobstructed path to admit shock waves 200 to this organ. This has the added benefit of generating maximum therapy to the afflicted organ in region 300 in such a way that the healing process can be stimulated more directly.

Again in each of these procedures as shown there is an invasive technique requiring the shock wave head 43 to enter either an access portal or an opening wherein the organ 100 is at least partially exposed to the exemplary shock waves 200 as can either be accomplished by a surgical procedure or any other means that would permit entry of the shock wave head 43 to the afflicted organ.

[0035] In Figs 16-20 exemplary shock waves 200 are illustrated, it must be appreciated that any of the shock wave patterns exhibited in Figs 1-12 can be used in the shock wave treatment of the various organs 100.

[0036] Heretofore such invasive techniques were not used in combination with shock wave therapy primarily because the Shockwaves were believed to be able to sufficiently pass through interfering body tissue to achieve the desired result in a non-invasive fashion. While this may be true, in many cases if the degenerative process is such that an operation is required then the combination of an operation in conjunction with Shockwave therapy only enhances the therapeutic values and the healing process of the patient and the organ such that regenerative conditions can be achieved that would include not only revascularization of the heart or other organs wherein sufficient or insufficient blood flow is occurring but also to enhance the improvement of ischemic tissue that may be occupying a portion of the organ. This ischemic tissue can then be minimized by the regenerative process of using shock wave therapy in the fashion described above to permit the tissue to rebuild itself in the region that has been afflicted.

[0037] As used throughout this application wherein the use of exemplary shock waves 200 in an unobstructed path has been described unobstructed path means that there is no or substantially no interfering tissue or bone skeletal mass between the shock wave head 43 and the treated organ. It is believed that the elimination of such interfering masses greatly enhances the control and the efficiency of the emitted exemplary shock waves 200 to create the desired beneficial healing effects and regenerative process needed for the organ to be repaired.

[0038] As shown in Figures 1 - 12 the use of these various acoustic shock wave forms can be used separately or in combination to achieve the desired therapeutic effect, as described later in this disclosure.

[0039] Furthermore such acoustic shock wave forms can be used in combination with drugs, chemical treatments, irradiation therapy or even physical therapy and when so combined the stimulated cells will more rapidly assist the body's natural healing response.

[0040] The present invention provides an apparatus for an effective treatment of indications, which benefit from low energy pressure pulse/ shock waves having nearly plane or even divergent characteristics. With an unfocused wave having nearly plane 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 pai n are very minor or even do not exist at all. [0041] In certain embodiments, the apparatus of the present invention is able to produce waves having energy density values that are below 0.1 mJ/mm2 or even as low as 0.000 00 1 mJ/mm.2. In a preferred embodiment, those low end values range between 0.1 - 0.001 mJ/mm2. With these low energy densities, side effects are reduced and the dose application is much more uniform. Additionally, the possibi lity of harming surface tissue is reduced when using an apparatus of the present invention that generates waves having nearly plane or divergent characteristics and larger transmission areas compared to apparatuses using a focused shock wave source that need to be moved around to cover the affected area. 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. Conversely off target or far-sighted convergent shock waves may be used to achieve satisfactory results as is disclosed later.

[0042] The treatment of the above mentioned indications are believed to be a first time use of acoustic shock wave therapy invasively. None of the work done to date has treated the above mentioned indications with convergent, divergent, planar or near-planar acoustic shock waves of low energy or focused shock waves in a direct unobstructed path from the emitting source lens or cover using the soft fluid filled organ as a transmitting medium directly. As is the use of acoustic shock waves for germicidal wound cleaning or preventive medical treatments. [0043] 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 o f 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. In the case of any operative surgical procedure the surgical area of the patient can be bombarded with these low energy waves to stimulate cellular release of healing agents and growth factors. This will dramatically reduce the healing process. Most preferably such patients may be provided more than one such treatment with an intervening dwell time for cellular relaxation prior to secondary and tertiary post operative treatments.

[0044] The underlying principle of these shock wave therapy methods is to stimulate the body's own natural healing capability. This is accomplished by deploying shock waves to stimulate strong cells in the tissue to activate a variety of responses. 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 treatment site, 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 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.

[0045] The use of shock waves as described above appears to involve factors such as thermal heating, light emission, electromagnetic field exposure, chemical releases in the cells as well as a microbiological response within the cells. Which combination of these factors plays a role in stimulating healing is not yet resolved. However, there appears to be a commonality in the fact that growth factors are released which applicants find indicative that otherwise dormant cells within the tissue appear to be activated which leads to the remarkable ability of the targeted organ or tissue to generate new growth or to regenerate weakened vascular networks in for example the cardio vascular system. This finding leads to a complimentary use of shock wave therapy in combination with stem cell therapies that effectively activate or trigger stem cells to more rapidly replicate enhancing the ability to harvest and culture more viable cells from the placenta, a nutrient culture of said stem cells, or other sources. The ability to stimulate stem cells can occur within the patients own body activating the naturally occurring stem cells or stem cells that have been introduced to the patient as part of^" a treatment beneficially utilizing stem cells. This is a significant clinical value in its own right.

[0046] In one embodiment, the invention provides for germicidal cleaning of diseased or infected areas and for wound cleaning generally.

[0047] The use of shock wave therapy requires a fundamental understanding of focused and unfocused shock waves, coupled with a more accurate biological or mo lecular model.

[0048] Focused shock waves are focused using ellipsoidal reflectors in electromechanical sources from a cylindrical surface or by the use of concave or convex lenses. Piezoelectric sources often use spherical surfaces to emit acoustic pressure waves which are self focused and have also been used in spherical electromagnetic devices. [0049] The biological model proposed by co-inventor Wolfgang Schaden provides a whole array of clinically significant uses of shock wave therapy.

[0050] Accepting the biological model as promoted by W. Schaden, the peak pressure and the energy density of the shock waves can be lowered dramatically. Activation of the body's healing mechanisms will be seen by in growth of new blood vessels and the release of growth factors.

[0051] The biological model motivated the design of sources with low pressure amplitudes and energy densities. First: spherical waves generated between two tips of an electrode; and second: nearly even waves generated by generalized parabolic reflectors. Third; divergent shock front characteristics are generated by an ellipsoid behind F2. Unfocused sources are preferably designed for extended two dimensional areas/volumes like skin. The unfocused sources can provide a divergent wave pattern or a nearly planar wave pattern and can be used in isolation or in combination with focused wave patterns yielding to an improved therapeutic treatment capability that is non¬ invasive with few if any disadvantageous contraindications. Alternatively a focused wave emitting treatment may be used wherein the focal point extends preferably beyond the target treatment site, potentially external to the patient. This results in the reduction of or elimination of a localized intensity zone with associated noticeable pain effect while providing a wide or enlarged treatment volume at a variety of depths more closely associated with high energy focused wave treatment. The utilization of a diffuser type lens or a shifted far-sighted focal point for the ellipsoidal reflector enables the spreading of the wave energy to effectively create a convergent but off target focal point. This insures less tissue trauma while insuring cellular stimulation to enhance the healing process. [0052] This method of treatment has the steps of, locating a treatment site, generating either convergent diffused or far-sighted focused shock waves or unfocused shock waves, of directing these shock waves to the treatment site; and applying a sufficient number of these shock waves to induce activation of one or more growth factors thereby inducing or accelerating healing.

[0053] The unfocused shock waves can be of a divergent wave pattern or near planar pattern or pre-convergence or convergent pattern preferably of a low peak pressure amplitude and density. Typically the energy density values range as low as 0.000001 mJ/mm² and having a high end energy density of below 1.0 mJ/mm², preferably 0.20 mJ/mm² or less. The peak pressure amplitude of the positive part of the cycle should be above 1.0 and its duration is below 1-3 microseconds.

[0054] The treatment depth can vary from the surface to the full depth of the treated organ. The treatment site can be defined by a much larger treatment area than the 0.10 - 3.0 cm² commonly produced by focused waves. The above methodology is particularly well suited for surface as well as sub-surface soft tissue organ treatments.

[0055] The above methodology is valuable in generation of tissue, vascularization and may be used in combination with stem cell therapies as well as regeneration of tissue and vascularization.

[0056] The methodology is useful in (re)vascularization of the heart, brain, liver, kidney and skin.

[0057] The methodology is useful in stimulating enforcement of defense mechanisms in tissue cells to fight infections from bacteria and can be used germicidally to treat or cleanse wounds or other target sites.

[0058] Conditions caused by cirrhosis of the liver can be treated by reversing this degenerative condition.

[0059] While the above listed indications cited above are not exhaustive nor intended to be limiting, it is exemplary of the wide range of beneficial uses of low energy and amplitude unfocused divergent or nearly planar shock waves, convergent shock waves, diffused shock waves or a combination of shock wave types in the treatment of humans and other mammals.

[0060] A most significant method of preventive medicine can be practiced that is fully enabled by the use of these relatively low amplitude and pressure shock waves. The method includes the steps of identifying high risk patients for a variety of potential conditions. Such condition could be by way of example heart disease caused by poor vascularization. After identifying a risk prone candidate providing one or a series of two or more exposure treatments with unfocused, divergent or near planar shock waves or convergent far-sighted focused shock waves or diffused shock waves to the treatment site, in this example the heart. Then after treatments the physician can optionally ultrasound visually or otherwise determine the increase in vascularization after a period of time.

Assuming an initial baseline determination of the heart vascularization had been initially conducted an estimate or calculation of improved vascularization of the site can be made. Th is procedure can be used for any at risk condition.

[0061] The implications of using the (re)generative features of thi s type of shock wave therapy are any weakened organ or tissue even bone can be strengthened to the point of reduc ing or eliminating the risk of irreparable damage or failure.

[0062] The stimulation of growth factors and activation of healing acceleration is particularly valuable to elderly patients and other high risk factor subjects.

[0063] Similar gains are visualized in organ transplant and complete organ regeneration, wherein a heart, liver, kidney, portions of the brain or any other organ or portions thereof of a human or animal may be transplanted into a patient, the organ being exposed to shock waves either prior to or after being transplanted.

[0064] Even more striking as mentioned earlier, early prevention therapies can be employed to stimulate tissue or organ modeling to be maintained within acceptable ranges prior to a degeneration occurring. This is extremely valuable in the prevention of heart disease for example. The methods would be to identify at risk patients based on family history or genetic disposition, physical condition, etc. and subjecting that patient to therapeutic shock wave therapy for the purpose of stimulating tissue repair effectively remodeling the patient's susceptible organ to be within accepted functional parameters. The objective being to preventively stimulate cellular tissue repairs to preemptively avoid a degenerative condition from occurring which may require invasive surgical procedures.

[0065] This preventive therapy is most needed to combat neurological degenerative conditions such as alzheimer's disease or brain trauma injuries. Kidney failure indications can similarly be pre-screened for susceptibility as well as the liver for cirrhosis and the heart for vascularization or any other degenerative condition.

[0066] In a second embodiment the shock wave method of treating a tissue, an organ or the entire body of a mammal be it human or an animal with a risk of exposure to chemical or radiation or post-occurrence of such an exposure requires the patient to be positioned in a convenient orientation to permit the source of the emitted waves to most directly send the waves to the target site to initiate shock wave stimulation of the target area with minimal, preferably no obstructing features in the path of the emitting source or lens.

[0067] The methodology is useful in stimulating enforcement of defense mechanisms in tissue cells to fight infections from bacteria and can be used germicidally to treat or cleanse wounds or other target sites which is a primary concern in the case of chemical or radiation burns resulting from such exposures to radiation or chemical agents.

[0068] While the above listed indications cited above are not exhaustive nor intended to be limiting, it is exemplary of the wide range of beneficial uses of low energy and amplitude unfocused divergent, planar or nearly planar shock waves, convergent shock waves, diffused shock waves or a combination of shock wave types in the treatment of humans and other mammals that are exposed to chemical or radiation or are about to be so exposed as the result of a therapeutic treatment or are at potential risk to such exposure..

[0069] A most significant method of preventive medicine can be practiced that is fully enabled by the use of these relatively low amplitude and pressure shock waves. The method includes the steps of identifying high risk patients for a variety of potential chemical or radiation risk conditions. Such condition could be by way of example cancer treatments. After identifying a risk prone candidate providing one or a series of two or more exposure treatments with unfocused, divergent, planar or near planar shock waves or convergent far-sighted focused shock waves or diffused shock waves to the treatment site, in this example the region surrounding or in proximity to malignant cells or tumors. Then after treatments the physician can optionally ultrasound visually or otherwise determine the increase in regeneration or vascularization in the treated tissue after a period of time. Assuming an initial baseline determination of the tissue regeneration or vascularization had been initially conducted an estimate or calculation of dosage requirements can be made. This procedure can be used for any at risk condition. After such a chemical or radiological treatment the surrounding tissues can be post-operatively shock wave treated as well.

[0070] The implications of using the (re)generative features of this type of shock wave therapy are any weakened organ or tissue even teeth or bone can be strengthened to the point of reducing or eliminating the risk of irreparable damage or failure.

[0071] The stimulation of growth factors and activation of healing acceleration within the cells of the treated tissues is particularly valuable to cancer patients and other high risk factor subjects exposed to radiation or chemical agents.

[0072] Even more striking as mentioned earlier, early prevention therapies can be employed to stimulate tissue or organ modeling to be maintained within acceptable ranges prior to an exposure to damaging chemicals or radiation occurring. This is extremely valuable in the prevention of radiation poisoning for example. The methods would be to identify at risk patients or workers based on family history and exposure risks, and subjecting that patient or worker to therapeutic shock wave therapy for the purpose of stimulating tissue repair or regeneration effectively remodeling the patient's susceptible organs to be within accepted functional parameters prior to exposure. The objective being to preventively stimulate cellular tissue repairs to preemptively avoid a degenerative condition from occurring which may result in the onset of cancer and require invasive surgical procedures. [0073] This preventive therapy is most needed to combat damaging chemical or radiation exposure which left untreated results in cellular destruction or any other degenerative conditions.

[0074] The treatment of the above mentioned tissue, organ or body of a patient or wo rker believed to be a first time use of acoustic shock wave therapy in the preventive pre-exposure or post-exposure to chemical agents or radiation. None of the work done to date has treated the above mentioned exposures with convergent, divergent, planar or near-planar acoustic shock waves of low energy or focused shock waves in a path from the emitting source lens or cover. Also this is believed to be a first time use of acoustic shock waves for germicidal wound cleaning or preventive medical treatments for such exposures.

[0075] The use of acoustic shock waves to patients exposed to chemical agents or drugs or to radiation exposure stimulates a cellular response of the treated tissues as well as a cellular response in the surrounding tissue. This response activates otherwise dormant cells to increase the body's own defense mechanisms, allowing the cells to limit the migration of tissue damage, but also to initiate the healing process. This feature means that the treating physician has the added benefit of a patient whose body will be strengthened to mitiga_te damage to otherwise healthy tissues and organs.

[0076] The nature of cancer treatments employing a combination of chemicals and radiation exposure to kill cancerous cells is well known to weaken the entire body's ability to defend from infections and associated diseases. The result is the patient is in a greatly weakened state overall. These treatments are so severe that the common problems of hair loss and overall nausea are well documented. These symptoms are generally reversible. The more serious complications are not reversible. In some cases gum damage and complete de struction of the teeth has been observed as a consequence of such treatments. The treatments are both cumulative in their adverse reactions and thus the effective treatment of the cancer cells also permanently damages otherwise healthy tissue and organs. The use of the Shock waves as described above stimulates these healthy cells to defend against this spill over intrusion. [0077] This means the physician can use these treatments with far less adverse reactions if he combines the treatments with one or more exposures to acoustic shock waves either before introducing chemical agents or radiation or shortly thereafter or both. This further means that the patient's recovery time should be greatly reduced because the patient treated with shock waves will have initiated a healing response that is much more aggressive than heretofore achieved without the cellular stimulation. The current use of medicat ions to stimulate such cellular activity is limited to absorption through the bloodstream via the blood vessels. Acoustic shock waves stimulate all the cells in the region treated activating an almost immediate cellular release of healing agents. Furthermore, as the use of other wise conflicting chemicals is avoided, adverse side effects can be limited to those medicaments used to destroy the cancerous cells. In other words the present invention is far more complimentary to such chemotherapy and radiation treatments in that the stimulation of otherwise healthy cells will greatly limit the adverse and irreversible effects on the surrounding non-cancerous tissues and organs. [0078] A further benefit of the use of acoustic shock waves is there are no known adverse indications when combined with the use of other medications or drugs. In fact the activation of the cells exposed to shock wave treatments only enhances cellular absorption of such medication making these drugs faster acting than when compared to non stimulated cells. As a result, it is envisioned that the use of one or more medicaments prior to, during or after subjecting the patient to acoustic shock waves will be complimentary to the treatment or pre¬ conditioning treatment for radiation or chemical exposures. It is further appreciated that certain drug therapies can be altered or modified to lower risk or adverse side effects when combined with a treatment involving acoustic shock waves as described above.

[0079] In the case wherein the patient is a victim of a chemical agent or radiation exposure as the result of an accident or an attack, the immediate use of shock waves shortly after exposure can be an effective tool in saving lives. The body's ability to recover is enhanced and the damaged tissue can be more quickly replaced by stimulated healthy cells which is a regenerative feature of the use of shock wave treatments.

[0080] This is particularly true in the case of chemical or radiation burns of the skin caused by agents like mustard gas or radiation. The wounded tissue is a source of infection which can lead to a complete failure of the body leading to death. The use of shock wave treatments is a valuable tool in such a case because acoustic shock waves can be provided on a virtually limitless basis as long as connected to an adequate power source. Normally supplies of medicines are limited and almost never near the area most in need. Accordingly vehicles similar to emergency trucks used to transport patients can be equipped with shock wave generators so that in field treatments can be conducted on a wide scale quickly. This alone could greatly reduce the loss of life that would occur by delays in treatment.

[0081] The present invention in a third embodiment provides a novel, non-invasive treatment therapy for conditions relating to infertility or impotency in males or females.

[0082] In the area of impotency, the subject or diagnosed patient often loses all interest in sexual activity or if actively interested, is unable to perform. This is most common in males, but can and does occur in females as well. [0083] The reasons for impotency can vary widely, but often the cause can be a physiological disorder relating to insufficient blood flow to and in the region of the reproductive organs or a lack of nerve responsiveness to stimulation in the reproductive tissues.

[0084] Similarly the reasons for infertility can vary widely and in females in particular the degenerative onset in the area of the reproductive tissues and organs occurs early in life such that women over 30 years of age more typically as they approach 40 lose a portion of their ability to conceive. This is a very natural response to aging and is not altogether unexpected. On the other hand many women in Western Europe and the United States are marrying later in life and thus those couples in the 30 through 40 age group desiring children are increasing in number. [0085] Accordingly, there is an increasing need to address the issues of infertility in both men and women. [0086] The current invention is particularly useful when applied to female subjects. Women differ from men in the physiological indicator of gender, which contributes to an as yet uncharacterized level of differential gene expression. In addition, there is a tremendous amount of normal variation between female subjects and between different samples from the same female subject. In particular, the female reproductive system and the menstrual cycle add an additional level of physiological variation to the analysis of samples derived from female subjects. As part of a monthly cycle the lining of the female uterus, the endometrium, undergoes a cycle of controlled tissue remodeling unparalleled in other organs. This cycle is presumably driven by changes in gene expression. [0087] Physiological variation between women and men complicates the design of effective therapies for women and the monitoring of therapeutic treatments in women. It is currently well accepted that gender differences result in extensive disparity in the ways males and females respond to therapeutic treatments for a variety of non-gender specific diseases including heart disease and stroke. The reasons for these differences, however, are not well understood, but the menstrual cycle is likely to be at least partially responsible. Much of the research into novel drugs and therapeutic treatments is done using male test subjects. Therefore, there is a great need in the art for methods of incorporating information about the physiological state of a female patient into the diagnosis and management of diseases.

[0088] Gender differences in the efficacy of drug therapy have been appreciated for many years, but little has been done to investigate these differences. It is believed that hormonal fluctuations within the menstrual cycle may be a primary cause of gender specific drug response. A systematic investigation of the physiological variation throughout the menstrual cycle, both under normal physiological conditions and in response to drug treatment, would be beneficial.

[0089] In another aspect, the current invention is used to treat diseases of the female reproductive system. Many disorders of the female reproductive system have relatively poor methods of diagnosis and prognosis and many are typically diagnosed based simply on patient perception, which tends to be unreliable. For example, pre-menstrual syndrome effects large numbers of women, but is typ ϊcally diagnosed only when other explanations for the observed symptoms are eliminated. More reliable methods of diagnosis such as the use of gene expression profiles for diagnosis and prognosis have been complicated by the changes in gene expression that accompany the normal physiological variation of the system.

[0090] Menopause is a woman's final menstrual period, but currently the actual event can be determined only in retrospect, after she has not had a period for 12 continuous months. Menopause can occur naturally any time between the mid-30s through the late 50s, but can also be brought on prematurely by events such as gynecological surgery, cancer therapy and certain illnesses and diseases. The current invention can be used to regenerate a molecular profile consistent with a diagnosis of pre-menopause status that would allow conception. [0091] In one embodiment the current invention relies on a diagnosis of diseases of the female reproductive organs. An expression profile from an experimental sample is compared to expression profiles from reference samples that match the experimental sample in physiological state. The reference samples represent a plurality of different disease states that effect the uterus and the experimental sample is identified as being of the disease state of the reference sample that is the closest match. The samples can be derived from, for example, endometrial tissue, myometrial tissue, and/or uterine tissue. Then these reproductive tissues and organs are treated using one or more exposures to acoustic shock waves.

[0092] In one aspect, a database of reference samples could be comprised of expression profiles from endometrial samples and data points identifying the physiological, pharmacological and/or disease state of the samples. These reference samples would be from many different individuals representing many different physiological, pharmacological and/or disease states. The reference samples can be derived from for example: normal tissue at different stages of development and differentiation, tissues affected with a variety of pathological conditions, including but not limited to, premenstrual syndrome, PMDD, stress urinary incontinence, polycystic ovarian disease, endometriosis, endometrial cancer, infertility, hormone imbalance, and tissue subjected to a variety of perturbations including but not limited to hormone replacement therapy, or chemical contraception. In one preferred embodiment, reference samples will be taken from individuals during routine doctor visits. In one embodiment the reference samples would represent different physiological states of the menstrual cycle including but not limited to the secretory and proliferative stages of the endometrium.

[0093] After such diagnosis using differential gene expression, as is taught in US 6,884,578 or any other diagnostic means that provides a baseline pre-treatment analysis, the patient is subjected to at least one, preferably a series of shock wave treatments to remodel or regenerate these reproductive tissues or organs. [0094] These treatments of a diagnosed patient can be accomplished on the reproductive tissues or organs of either male or female patients. The goal being to correct or repair any degenerative condition or defect. [0095] In some cases the shock wave treatments can be complimentarily used with fertility medications if the physician so desires.

[0096] Similarly the patient may require an invasive surgical procedure to open a blocked fallopian tube or other type reproductive defect or disorder. In such a case the shock wave treatment can be employed either prior during or post operatively and thus aid in the healing and mending process.

[0097] The ability to enable revascularization in the area of the reproductive organs is quite beneficial in not only the area of infertility, but also for treating conditions of impotency.

[0098] Numerous drugs are now provided to enhance male performance most of which results in an increase in blood flow to achieve the desired results. All of these drugs run the risk of causing a stroke or heart attack. The present invention can be used to regenerate the vascular system locally in the region of the heart or the reproductive system and can achieve the same or similar benefits of increased blood flow on a more continuous basis compared to the temporary response of drugs, but without any of the adverse consequences.

[0099] This is particularly useful for women for whom such a sexual arousing stimulant drug has yet to be accepted. The use of shock waves can create an improved sensory response in the region of the vagina which makes the female's response to stimulation during intercourse more self satisfying greatly facilitating the ability to reach or achieve a climax. The shock wave treatments not only improve blood flow in the reproductive tissues, but also can improve nerve sensitivity and the network of nerves in the region of the vagina facilitating responsiveness to stimulation.

[00100] To better appreciate how shock waves work one must gain an appreciation of the apparatus and devices used to generate such wave patterns.

[00101] In the shock wave method of treating a tissue, an organ or the entire body of a patient diagnosed with infertility or impotence requires the patient to be positioned in a convenient orientation to permit the source of the emitted waves to most directly send the waves to the target site to initiate shock wave stimulation of the target area with minimal, preferably no obstructing features in the path of the emitting source or lens. Assuming the target area is within a projected area of the wave transmission, a single transmission dosage of wave energy may be used. Tine 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/mm² to 1.0 mJ/mm² or less, most typically below 0.2 mJ/mm². 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 tissue target site is disposed pre-convergence inward of the geometric focal point of the emitted wave transmission.

[00102] These shock wave energy transmissions are effective in stimulating a cellular response and can be accomplished without creating the cavitation bubbles in the tissue of the target site. This effectively insures the tissue or organ does not have to experience the sensation of hemorrhaging so common in the higher energy focused wave forms having a focal point at or within the targeted treatment site.

[00103] If the target site is a reproductive tissue or organ subjected to a surgical procedure exposing at least some if not all of the tissue or organ within the body cavity the target site may be such that the patient or the generating source must be reoriented relative to the site and a second, third or more treatment dosage can be administered. The fact that the dosage can be at a low energy the common problem of localized hemorrhaging is reduced making it more practical to administer multiple dosages of waves from various orientations to further optimize the treatment and cellular stimulation of the target site. Heretofore focused high energy- multiple treatments induced pain and discomfort to the patient. The use of low energy focused or un-focused waves at the target site enables multiple sequential treatments.

[00104] The methodology is useful in stimulating enforcement of defense mechanisms in tissue cells to fight infections from bacteria and can be used germicidally to treat or cleanse wounds or other reproduction target sites which is a primary concern in the case of treating conditions of infertility.

[00105] While the above listed indications cited above are not exhaustive nor intended to be limiting, it is exemplary of the wide range of beneficial uses of low energy and amplitude unfocused divergent, planar or nearly planar shock waves, convergent shock waves, diffused shock waves or a combination of shock wave types in the treatment of humans and other mammals that are infertile or impotent.

[00106] A most significant method of preventive medicine can be practiced that is fully enabled by the use of these relatively low amplitude and pressure shock waves. The method includes the steps of identifying high risk patients for a variety of potential infertility or impotence conditions. Such condition could be by way of example ovarian cancer treatments. After identifying a risk prone candidate providing one or a series of two or more exposure treatments with unfocused, divergent, planar or near planar shock waves or convergent far-sighted focused shock waves or diffused shock waves to the treatment site, in this example the region surrounding or in proximity to malignant cells or tumors. Then after treatments the physician can optionally ultrasound visually or otherwise determine the increase in regeneration or vascularization in the treated tissue after a period of time. Assuming an initial baseline determination of the tissue regeneration or vascularization had been initially conducted an estimate or calculation of treatment requirements can be made. If required the physician can conduct a surgical procedure or alternatively prescribe medications. This procedure can be used for any at risk reproductive condition. After such a surgery or medical drug treatment the surrounding tissues can be post-operatively shock wave treated as well. [00107] In a fourth embodiment of the present invention the pressure pulse or shock wave method of treating a tissue, an organ or the entire body of a host be it mechanical system or a mammal, the host system or mammal be it human or an animal with a risk of exposure to a biofilm or post-occurrence of such biofilms requires the host patient to be positioned in a convenient orientation to permit the source of the emitted waves to most directly send the waves to the target site to initiate pressure pulse or shock wave stimulation of the target area with minimal, preferably no obstructing features in the path of the emitting source or lens. Assuming the biofilm target area or site is within a projected area of the wave transmission, a single transmission dosage of wave energy ma^y be used. 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/mm² to 1.0 mJ/mm² or less, most typically below 0.2 mJ/mm². 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 tissue target site is disposed pre-convergence inward of the geometric focal point of the emitted wave transmission. In treating some hard to penetrate biofilms, the pressure pulse more preferably is a high energy target focused wave pattern which can effectively attack the biofilm outer structure or barrier shield causing fractures or openings to be created to expose the colonies of microorganisms within the biofilm to the germicidal effects of the pressure pulses or shock waves. This emitted energy destroys the underlying microorganism's cellular membranes. In addition the fragmentation of the biofilms outer barrier is then easily absorbed by or flushed out of the host. The surrounding healthy cells in the region treated are activated initiating a defense mechanism response to assist in eradication of the unwanted infection.

[00108] The present method may need precise site location and can be used in combination with such known devices as ultrasound, cat-scan or x-ray imaging if needed. The physician's general understanding of the anatomy of the patient may be sufficient to locate the target area to be treated. This is particularly true when the exposed tissue or portion of the infected body or organ is visually within the surgeon's line of sight and this permits the lens or cover of the emitting shock wave source to impinge on the affected organ or tissue directly or through a transmission enhancing gel, water or fluid medium during the pressure pulse or shock wave treatment. The treated area can withstand a far greater number of shock waves based on the selected energy level being emitted. For example at very low energy levels the stimulation exposure can be provided over prolonged periods as much as 20 minutes if so desired. At higher energy levels the treatment duration can be shortened to less than a minute, less than a second if so desired. The limiting factor in the selected treatment dosage is avoidance or minimization of surrounding cell hemorrhaging and other kinds of damage to the surrounding cells or tissue while still providing a stimulating stem cell activation or a cellular release or activation of VEGF and other growth factors while simultaneously germicidally attacking the biofilm barrier and underlying colony of microorganisms. [00109] Due to the wide range of beneficial treatments available it is believed preferable that the optima! 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. In the case of any operative surgical procedure the surgical area of the patient can be bombarded with these energy waves to stimulate cellular release of healing agents and growth factors. This will dramatically reduce the healing process time. Most preferably such patients may be provided more than one such treatment with an intervening dwell time for cellular relaxation prior to secondary and tertiary post operative treatments. [001 10] The underlying principle of these pressure pulse or shock wave therapy methods is to attack the biofilm directly and to stimulate the body's own natural healing capability This is accomplished by deploying shock waves to stimulate strong cells in the surrounding tissue to activate a variety of responses 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 treatment site, in particular, but more interestingly a systemic response in areas more removed from the wave form pattern Th is is believed to be one of the reasons molecular stimulation can be conducted at thieshold energies heretofore believed to be well below those commonly accepted as required Accordingly not only can the energy intensity be reduced m 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 weaken the biofilms protective outer barrier or shield This weakening can be achieved by any fracture or opening that exposes the underlying colony of microorganisms

[001 1 1] In one embodiment, the invention provides for germicidal cleaning of biofilm diseased or infected areas and for wound cleaning generally after exposure to surgical procedures

[001 12J The unfocused souices can provide a divergent wave pattern a planar or a nearly planar wave pattern and can be used in isolation or in combination with focused wave patterns yielding to an improved therapeutic treatment capability that is non-invasive with few if any disadvantageous contraindications Alternatively a focused wave emitting tieatment may be used wherein the focal point extends preferably beyond the target treatment site, potentially external to the patient This results in the reduction of or elimination of a localized intensity zone with associated noticeable pain effect while providing a wide or enlarged treatment volume at a variety of depths more closely associated with high energy focused wave treatment The utilization of a diffuser type lens or a shifted far- sighted focal point for the ellipsoidal reflector enables the spreading of the wave energy to effectively create a convergent but off target focal point This insures less tissue trauma while insuring cellular stimulation to enhance the healing process and control the migration or spreading of the infection within the host More pieferably if a resident biofilm location can be isolated and a short, but high energy focused wave pattern can be emitted on the outer barrier of the biofilm causing a fracture or fragmentation i n the outer barrier and then a lower unfocused energy transmission can be applied to provide an overall germicidal treatment and surrounding cell stimulation to destroy the biofilm infected site and eradicate the resultant microbial debris

[00113] This method of treatment has the steps of, locating a biofilm treatment site, region or location, generating either focused, convergent diffused or far-sighted focused shook waves or unfocused shock waves, directing these shock waves to the biofilm treatment site, and applying a suffic ient number of these shock waves to induce an outer barrier biofilm weakening while simultaneously activating one or more growth factors in the surrounding tissue cells thereby inducing or accelerating healing

[001 14] The methodology is useful in stimulating enforcement of defense mechanisms in tissue cells to fight infections from bacteria and can be used germicidally to treat or cleanse wounds or other biofilm target sites which is a primary concern in the case of treating human diseases such as native valve endocarditis, cystic fibrosis, periodontal gum disease and urinary or digestive tract infections resulting from such exposures to biofilm type agents fOOl 15] While the above listed indications cited above are not exhaustive nor intended to be limiting, it is exemplary of the wide range of beneficial uses of high energy focused or low energy and amplitude unfocused divergent, planar or nearly planar shock waves, convergent shock waves, diffused shock waves or a combination of shock wave types in the treatment of humans and other mammals that are exposed to a biofilm type infection or are at high risk to be so exposed as the result of a high potential risk to such biofilm infectious exposure. [001 16] A most significant method of preventive medicine can be practiced that is fully enabled by the use of these relatively low amplitude and pressure shock waves. The method includes the steps of identifying high risk patients for a variety of potential risk conditions. Such condition could be by way of example leaking heart valves, urinary infections, degenerative gum disease or cystic fibrosis. After identifying a risk prone candidate providing one or a series of two or more exposure treatments with focused or unfocused, divergent, planar or near planar shock waves or convergent far-sighted focused shock waves or diffused shock waves to the treatment site, in this example the region surrounding or in proximity to a biofilm occurrence risk location. Then after treatments the physician can optionally ultrasound visually or otherwise determine the increase in regeneration or vascularization in the treated tissue after a period of time. Assuming an initial baseline determination of the tissue regeneration or vascularization had been initially conducted an estimate or calculation of dosage requirements can be made. This procedure can be used for any biofilm at risk condition. After a surgical repair procedure the surrounding tissues can be post-operatively shock wave treated as well.

[001 17] The implications of using the (re)generative features of this type of shock wave therapy are any biofilm weakened organ or tissue even teeth or bone can be strengthened to the point of reducing or eliminating the risk of irreparable damage or failure as a result of microbial infections.

[001 18] The stimulation of growth factors and activation of healing acceleration within the cells of the treated tissues is particularly valuable to host patients and other high risk factor subjects wherein conventional antibiotic treatments have been unsuccessful.

[001 19] Even more striking as mentioned earlier, early prevention therapies can be employed to stimulate tissue or organ modeling to be maintained within acceptable ranges prior to an exposure to biofilm infections. This is extremely valuable in the prevention of spreading the infection for example. The methods would be to identify at risk patients with a known biofilm exposure risk, and subjecting that patient to therapeutic shock wave therapy for the purpose of stimulating tissue repair or regeneration effectively remodeling the patient's susceptible organs to be within accepted functional parameters prior to exposure to a biofilm infection. The objective being to preventively stimulate cellular tissue repairs to preemptively avoid a degenerative condition from occurring which may result in the onset of an antibiotic resistant infection which can require invasive surgical procedures. [00120] This preventive therapy is most needed to combat biofilm exposure which left untreated results in cellular destruction or any other degenerative conditions.

[00121] In some cases the first use of a high energy focused shock wave targeting the biomass may be trie best approach to weaken the outer barrier of the shield of the biomass followed by a transmission of lower energy unfocused wave patterns, the combination being the most effective in germicidal destruction of the biofilm mass. [00122] The treatment of the above mentioned tissue, organ or body of a patient is believed to be a first time use of acoustic shock wave therapy in the preventive pre-exposure or post-exposure to biofilm infections. None of the work done to date has treated the above mentioned biofilm infections with convergent, divergent, planar or near- planar acoustic unfocused shock waves of low energy or high energy focused shock waves in a germicidal transmission path from the emitting source lens or cover to the infection. A lso this is believed to be a first time use of acoustic shock waves for germicidal wound cleaning or preventive medi cal treatments for such exposures. [00123] The use of acoustic shock waves to patients exposed to biofilm infections stimulates a cellular response of the treated tissues as well as a cellular response in the surrounding tissue. This response activates otherwise dormant cells to increase the body's own defense mechanisms, allowing the cells to limit the migration of the infection and resultant tissue damage, but also to initiate the healing process. This feature means that the treating physician has the added benefit of a patient whose body will be strengthened to mitigate damage to otherwise healthy tissues and organs.

[00124] The nature of infectious disease treatments employing only antibiotics to kill infections is well known to actually make biofilm protected microorganisms mutate making them even harder to kill. The result is the patient is in a greatly weakened state overall. These mutant strains are so severe that the common antibiotic treatments are losing their ability to stop the spread of some infections which is well documented. These symptoms are generally reversible. The more serious complications may not be reversible. In some cases gum damage and complete destruction of the teeth has been observed as a consequence of such failed treatments. These antibiotic treatments can be cumulative in their adverse reactions and thus the effective treatment of the infections can also permanently damage otherwise healthy tissue and organs. The use of the shock waves as described above stimulates these healthy cells to defend against this spill over intrusion.

[00125] This means the physician can use these antibiotic treatments with far less adverse reactions if he combines the treatments with one or more exposures to acoustic shock waves either before introducing chemical antibiotic agents or shortly thereafter or both. This further means that the patient's recovery time should be greatly reduced because the patient treated with shock waves will have initiated a healing response that is much more aggressive than heretofore achieved without the cellular stimulation provided by pressure pulse or shock wave treatments. The current use of medications to stimulate such cellular activity is limited to absorption through the bloodstream via the blood vessels. Acoustic shock waves stimulate all the cells in the region treated activating an almost immediate cellular release of infection fighting and healing agents. Furthermore, as the use of other wise conflicting chemicals is avoided, adverse side effects can be limited to those medicaments used to destroy the infectious cells. In other words the present invention is far more complimentary to such antibiotic treatments in that the stimulation of otherwise healthy cells will greatly limit the adverse and irreversible effects on the surrounding non-infected tissues and organs.

[00126] A further benefit of the use of acoustic shock waves is there are no known adverse indications when combined with the use of other medications or drugs. In fact the activation of the cells exposed to shock wave treatments only enhances cellular absorption of such medication making these drugs faster acting than when compared to non stimulated cells. As a result, it is envisioned that the use of one or more medicaments prior to, during or after subjecting the patient to acoustic shock waves will be complimentary to the treatment or pre¬ conditioning treatment for biofilm exposures. It is further appreciated that certain drug therapies can be altered or modified to lower risk or adverse side effects when combined with a treatment involving acoustic shock waves as described above. [00127] In the case wherein the patient is a victim of a biofilm as the result of a biological accident or a biological attack, the immediate use of shock waves shortly after exposure can be an effective tool in saving lives. The body's ability to recover is enhanced and the damaged tissue can be more quickly replaced by stimulated healthy cells which is a regenerative feature of the use of shock wave treatments.

[00128] This is particularly true in the case of infections of the skin caused by biological agents. The wounded tissue is a source of rapidly spreading infection which can lead to a complete failure of the body leading to death. The use of shock wave treatments is a valuable tool in such a case because acoustic shock waves can be provided on a virtually limitless basis as long as connected to an adequate power source. Normally supplies of medicines are limited and almost never near the area most in need. Accordingly vehicles similar to emergency trucks used to transport patients can be equipped with shock wave generators so that in field treatments can be conducted on a wide scale quickly. This alone could greatly reduce the loss of life that would occur by delays in treatment. [00129] In a fifth embodiment of the present invention relates to the use of various therapeutic pressure pulse wave patterns or acoustic shock wave patterns as illustrated in figures 1 - 12 for treating various periodontal diseases or conditions or for preventing such conditions from occurring. 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 periodontal diseases.

[00130] With reference to figures 13 and 13A, a perspective view of a portion of the periodontal region 200 is shown. The gingival tissue 100, more commonly referred to as the gums 1 10, and the underlying alveolar (socket) bone 1 1 1 supports the teeth 1 12. In a region between the teeth 1 12 and the gums 1 I O called the gingival crevice area 120 is a region in which bacteria colonize on tooth surfaces to form bacterial plaque biofilms 102 which is the principal source of periodontal diseases.

[00131] The current preventive procedure used to eliminate bacterial plaque is periodic tooth cleaning procedures which involve mechanically shearing the accretions of plaque from the tooth structure. This mechanical treatment is called debridement and at best its use is of a transient benefit as the bacteria simply re-colonize the root surface. Accordingly periodic teeth cleaning is best performed at least twice a year.

[00132] In dentistry, a current treatment can be ultrasonic debridement which is practiced using a relatively blunt metal tipped instrument that is applied to the root surface below the gum line. The metal tip vibrates at ultrasonic frequencies and breaks the calculus (tartar) attachment to the root of the tooth. Calculus is the hardened substance that attaches to both the tooth structure above and below the gum line. The ultrasonic tip is used in both areas. Patients with periodontal disease typically have sub and supra-gingival calculus, but not always. Once the calculus is removed, it is hoped that the tissue (bone, ligament, gingival) will regenerate, but this is very often not the case. The next step in current treatment is surgery.

[00133] Shock waves are a completely different technology and a quantum leap beyond ultrasonic debridement. 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 periodontal disease by causing the structure of the bone, ligament attachment of root to bone and tissue architecture to be regenerated. This is a phenomenal advancement in the current approach which includes difficult surgery. If surgery could be replaced in many cases, it would save millions of dollars, gain wide acceptance (non-invasive) and be a tremendous boon to patients world wide. The anaerobic sub-gingival bacteria (oxygen-hating below the gum) are thought to be the major culprit in periodontal disease. These anaerobes are commonly found in periodontal biofilms.

[00134] Ideally the treatments to remove the bacterial plaque would not only eradicate the bacteria, but would also provide or stimulate a germicidal protective feature that would inhibit the bacteria from re-colonizing these regions. [00135] The time release of microspheres of medicaments placed in the gingival crevice area as described in US 6,726,898 was an attempt at this inhibiting effect.

[00136] As was mentioned the use of antibiotics has its own detrimental drawbacks and is thus far more complicated and less effective than needed in the area of treating these complex periodontal biofilms. [00137] The present invention employs the use of pressure pulses or shock waves to stimulate a germicidal cellular response that kills the bacteria laden periodontal biofilms while stimulating a tissue regenerative healing process that activates the tissue cells to defend against these microbial agents.

[00138] In the pressure pulse or shock wave method of treating a tissue, an organ or the entire body of a host be it mechanical system or a mammal, the host system or mammal be it human or an animal with a risk of exposure to a periodontal biofϊlm or post-occurrence of such periodontal biofilms requires the host patient to be positioned in a convenient orientation to permit the source of the emitted waves to most directly send the waves to the target site to initiate pressure pulse or shock wave stimulation of the target area with minimal, preferably no obstructing features in the path of the emitting source or lens. Assuming the treatment region is accessible through the mouth then the shock wave head 43 can be inserted and placed directly on the treatment region. Alternatively the shock wave head 43 can be placed externally on the skin and transmit the exemp lary emitted shock wave representative patterns 200 through the cheek tissue 1 17 for example and into the adjacent gingival tissue 100 to be treated, as shown in Fig 14, as previously mentioned any of the representative shock wave patterns illustrated in figures 1-12 may be used. Preferably the outer skin tissue is pressed against the treatment region to insure the transmission loss is minimal. In some cases the gums or teeth may benefit or require numbing prior to treatment. This is particularly true if the use of high energy focused waves are being transmitted that stimulate the sensitive nerves in the treatment area. Assuming the periodontal biofilm target area or site is within a projected area of the wave transmission, a single transmission dosage of wave energy may be used. The transm ission 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/mm² to 1.0 mJ/mm² or less, most typically below 0.2 mJ/mm². 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 tissue target site is disposed pre-convergence inward of the geometric focal point of the emitted wave transmission. In treating some hard to penetrate periodontal biofilms, the pressure pulse more preferably is a high energy target focused wave pattern which can effectively attack the biofϊlm outer structure or barrier shield causing fractures or openings to be created to expose the colonies of microorganisms within the biofilm to the germicidal effects of the pressure pulses or shock waves. This emitted energy destroys the underlying microorganism's cellular membranes. In addition the fragmentation of the biofilms outer barrier is then easily absorbed by or flushed out of the host. The surrounding healthy cells in the region treated are activated initiating a defense mechanism response to assist in eradication of the unwanted infection.

[00139] The underlying principle of these pressure pulse or shock wave therapy methods is to attack the periodontal biofilm directly and to stimulate the body's own natural healing capability. This is accomplished by deploying shock waves to stimulate strong cells in the surrounding tissue to activate a variety of responses. 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 treatment site, in particular, but more interestingly a systemic response in areas more removed from the wave form pattern. ITi is 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 weaken the periodontal biofilms protective outer barrier or shield. This weakening can t>e achieved by any fracture or opening that exposes the underlying colony of microorganisms.

[00140] In one embodiment, the invention provides for germicidal cleaning of periodontal biofilm diseased or infected areas and for wound cleaning generally after exposure to surgical procedures.

[00141] The biological model motivated the design of sources with low pressure amplitudes and energy densities. First: spherical waves generated between two tips of an electrode; and second: nearly even waves generated by generalized parabolic reflectors. Third: divergent shock front characteristics are generated by an ellipsoid behind £2. Unfocused sources are preferably designed for extended two dimensional areas/volu mes like skin. The unfocused sources can provide a divergent wave pattern a planar or a nearly planar wave pattern and can be used in isolation or in combination with focused wave patterns yielding to an improved therapeutic treatment capability that is non-invasive with few if any disadvantageous contraindications. Alternatively a focused wave emitting treatment may be used wherein the focal point extends preferably beyond the target treatment site, potentially external to the patient. This results in the reduction of or elimination of a localized intensity zone with associated noticeable pain effect while providing a wide or enlarged treatment volume at a variety of depths more closely associated with high energy focused wave treatment. The utilization of a diffuser type lens or a shifted far-si .ghted focal point for the ellipsoidal reflector enables the spreading of the wave energy to effectively create a convergent but off target focal point. This insures less tissue trauma while insuring cellular stimulation to enhance the healing process and control the migration or spreading of the infection within the host. More preferably if a resident periodontal biofilm location can be isolated and a short, but high energy focused wave pattern can be emitted on the outer barrier of the biofilm causing a fracture or fragmentation in the outer barrier and then a lower unfocused energy transmission can be applied to provide an overall germicidal treatment and surrounding cell stimulation to destroy the biofilm infected periodontal site and eradicate the resultant microbial debris.

[00142] This method of treatment has the steps of, locating a periodontal biofilm treatment site, region or location, generating either focused, convergent diffused or far-sighted focused shock waves or unfocused shock waves; directing these shock waves to the periodontal biofilm treatment site; and applying a sufficient number of these shock waves to induce an outer barrier biofilm weakening while simultaneously activating one or more growth factors in the surrounding tissue cells thereby inducing or accelerating healing. [00143] A most significant method of preventive medicine can be practiced that is fully enabled by the use of these relatively low amplitude and pressure shock waves. The method includes the steps of ϊ dentifying high risk patients for a variety of potential risk conditions. Such condition could be by way of example l eaking heart valves, urinary infections, degenerative gum disease or cystic fibrosis. After identifying a risk prone candidate providing one or a series of two or more exposure treatments with focused or unfocused, divergent, planar or near planar shock waves or convergent far-sighted focused shock waves or diffused shock waves to the treatment site, in this example the region surrounding or in proximity to a biofϊlm occurrence risk location. Then after treatments the physician can optionally ultrasound visually or otherwise determine the increase in regeneration or vascularization in the treated tissue after a period of time. Assuming an initial baseline determination of the tissue regeneration or vascularization had been initially conducted an estimate or calculation of dosage requirements can be made. This procedure can be used for any biofϊlm at risk condition. After a surgical repair procedure the surrounding tissues can be post-operatively shock wave treated as well.

[00144] The implications of using the (re)generative features of this type of shock wave therapy are any biofilm weakened organ or tissue even teeth or bone can be strengthened to the point of reducing or eliminating the risk of irreparable damage or failure as a result of microbial infections.

[00145] Even more striking as mentioned earlier, early prevention therapies can be employed to stimulate tissue or organ modeling to be maintained within acceptable ranges prior to an exposure to biofilm infections. This is extremely valuable in the prevention of spreading the infection for example. The methods would be to identify at risk patients with a known biofilm exposure risk, and subjecting that patient to therapeutic shock wave therapy for the purpose of stimulating tissue repair or regeneration effectively remodeling the patient's susceptible organs to be within accepted functional parameters prior to exposure to a biofilm infection. The objective being to preventively stimulate cellular tissue repairs to preemptively avoid a degenerative condition from occurring which may result in the onset of an antibiotic resistant infection which can require invasive surgical procedures.

[00146] This preventive therapy is most needed to combat biofϊlm exposure which left untreated results in cellular destruction or any other degenerative conditions. In the area of dental cleaning appointments or a dental prophylaxis or prophy, the use of pressure pulse waves or acoustic shock waves can be administered by a trained dental hygienist. Unlike current ultrasonic cleaning now available; the acoustic shock wave provides a far more advanced tissue stimulation which activates a germicidal response that continues for many weeks after treatment and thus is a natural defense method of healing that in most cases of periodontal biofilm exposure would not need supplemental antibiotics.

[00147] The treatment of the above mentioned tissue, organ or body of a patient is believed to be a first time use of acoustic shock wave therapy in the preventive pre-exposure or post-exposure to periodontal biofϊlm infections. None of the work done to date has treated the above mentioned biofilm infections with convergent, divergent, planar or near-planar acoustic unfocused shock waves of low energy or high energy Focused shock waves in a germicidal transmission path from the emitting source lens or cover to the infection. Also this is believed to be a first time use of acoustic shock waves for germicidal wound cleaning or preventive medical treatments for such exposures.

[00148] The nature of infectious disease treatments employing only antibiotics to kill infections is well known to actually make biofϊlm protected microorganisms mutate making them even harder to kill. The result is the patient is in a greatly weakened state overall. These mutant strains are so severe that the common antibiotic treatments are losing their ability to stop the spread of some infections which is well documented. These symptoms are generally reversible. The more serious complications may not be reversible. In some cases gum damage and complete destruction of the teeth has been observed as a consequence of such failed treatments. These antibiotic treatments can be cumulative in their adverse reactions and thus the effective treatment of the infections can also permanently damage otherwise healthy tissue and organs. The use of the shock waves as described above stimulates these healthy cells to defend against this spill over intrusion.

[00149] This means the physician can use these antibiotic treatments with far less adverse reactions if he combines the treatments with one or more exposures to acoustic shock waves either before introducing chemical antibiotic agents or shortly thereafter or both. This further means that the patient's recovery time should be greatly reduced because the patient treated with shock waves will have initiated a healing response that is much more aggressive than heretofore achieved without the cellular stimulation provided by pressure pulse or shock wave treatments. The current use of medications to stimulate such cellular activity is limited to absorption through the bloodstream via the blood vessels. Acoustic shock waves stimulate all the cells in the region treated activating an almost immediate cellular release of infection fighting and healing agents. Furthermore, as the use of other wise conflicting chemicals is avoided, adverse side effects can be limited to those medicaments used to destroy the infectious cells. In other words the present invention is far more complimentary to such antibiotic treatments in that the stimulation of otherwise healthy cells will greatly limit the adverse and irreversible effects on the surrounding non-infected tissues and organs.

[00150] A further benefit of the use of acoustic shock waves is there are no known adverse indications when combined with the use of other medications or drugs. In fact the activation of the cells exposed to shock wave treatments only enhances cellular absorption of such medication making these drugs faster acting than when compared to non stimulated ceils. As a result, it is envisioned that the use of one or more medicaments prϊ or to, during or after subjecting the patient to acoustic shock waves will be complimentary to the treatment or pre¬ conditioning treatment for periodontal biofilm exposures. It is further appreciated that certain drug therapies can be altered or modified to lower risk or adverse side effects when combined with a treatment involving acoustic shock waves as described above.

[00151] In a sixth embodiment of the present invention relates to the use of various therapeutic pressure pulse wave patterns or acoustic shock wave patterns as illustrated in figures 1 - 12 for treating nerve damage or various neurological diseases or conditions or for preventing such conditions from occurring. 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 diseases.

[00152] With reference to figures 15, a perspective view of a portion of the treatment volume or region 3O0 is shown. The neurological tissue 100, more commonly referred to as the brain 100, is the principal source of neurological activity.

[00153] Shock waves are a completely different technology and a quantum leap beyond other forms of neurological 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 nerve damage or neurological disease by regenerating or repairing the neurological tissue or nerve architecture to be regenerated. This is a phenomenal advancement in the current approach which includes difficult surgery. If surgery could be replaced in many cases, it would save millions of dollars, gain wide acceptance (non-invasive) and be a tremendous benefit to patients world wide.

[00154] The present invention employs the use of pressure pul ses or shock waves to stimulate a neuron or cellular nerve response stimulating a tissue regenerative healing process that activates the tissue or nerve cells surrounding the damaged nerves as well as the damaged nerves or neurons to initiate a systemic healing process. [00155] In the pressure pulse or shock wave method of treating a tissue, an organ or the entire body of a host be it mechanical system or a mammal, the host system or mammal be it human or an animal with a risk of degenerative neurological or nerve damage or post-occurrence of such damage requires the host patient to be positioned in a convenient orientation to permit the source of the emitted waves to most directly send the waves to the target site to initiate pressure pulse or shock wave stimulation of the target area or zone with minimal, preferably with little or no obstructing features in the path of the emitting source or lens. Assuming the treatment region is accessible through an open surgical access region then the shock wave head 43 can be inserted and placed directly on or adjacent to the treatment region 300. Alternatively the shock wave head 43 can be placed externally on the skull and transmit the emitted shock wave patterns through the skin, cranial bone tissue 1 16 for example and into the adjacent brain tissue 100 to be treated, as shown in Fig 15. In the case of extracorporeal non-invasive treatments of damaged nerves, preferably the outer skin tissue is pressed against the treatment region to insure the transmission loss is minimal. In some cases the treatment zone may benefit or require numbing prior to treatments in advance of surgical procedures. This is particularly true if the use of high energy focused waves are being transmitted through bone tissue to stimulate the sensitive nerves in the treatment area. Assuming the target area or site is within a projected area of the wave transmission, a single transmission dosage of wave energy may be used. 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 m J/mm² to 1.0 mJ/mm² or less, most typically below 0.2 mJ/mm². 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 tissue target site is disposed pre-convergence inward of the geometric focal po> int of the emitted wave transmission. In treating some hard to penetrate regions, the pressure pulse more preferably is a high energy target focused wave pattern which can effectively penetrate through outer structures prior to being dampened while still exposing the nerves or neurons to activating pressure pulses or shock waves. This emitted energy preferably stimulates the cells without rupturing cellular membranes. The surrounding healthy cells in the region treated are activated initiating a defense mechanism response to assist in eradication of the unwanted infection or diseased tissue while stimulating new growth.

[00156] These shock wave energy transmissions are effective in stimulating a cellular response and can be accomplished without creating the cavitation bubbles in the tissue of the target site when employed in other than site targeted high energy focused transmissions. This effectively insures the tissue or organ does not have to experience the sensation of hemorrhaging so common in the higher energy focused wave forms having a focal point at or within the targeted treatment site. [00157] If the target site is an organ like the brain subjected to a surgical procedure exposing at least some if not all of the organ within the body cranial cavity the target site may be such that the pati ent or the generating source must be reoriented relative to the site and a second, third or more treatment dosage can be administered. The fact that some if not all of the dosage can be at a low energy the common problem of locali zed hemorrhaging is reduced making it more practical to administer multiple dosages of waves from various ori entations to further optimize the treatment and cellular stimulation of the target site. Heretofore focused high energy multiple treatments induced pain and discomfort to the patient. The use of low energy focused or un-focused waves at the target site enables multiple sequential treatments.

[00158] The present method may need precise site location and can be used in combination with such known devices as ultrasound, cat-scan or x-ray imaging if needed. The physician's general understanding of the anatomy of the patient may be sufficient to locate the target area to be treated. This is particularly true when the exposed nerve tissue or portion of the trauma to the body or organ is visually within the surgeon's line of sight and this permits the lens or cover of the emitting shock wave source to impinge on the affected organ or tissue directly or through a transmission enhancing gel, water or fluid medium during the pressure pulse or shock wave treatment. The treated area can withstand a far greater number of shock waves based on the selected energy level being emitted. For example at very low energy levels the stimulation exposure can be provided over prolonged periods as much as 20 minutes if so desired. At higher energy levels the treatment duration can be shortened to less than a minute, less than a second if so desired. The limiting factor in the selected treatment dosage is avoidance or minimization of surrounding cell hemorrhaging and other kinds of damage to the surrounding cells or tissue while still providing a stimulating stem cell activation or a cellular release or activation of proteins such as brain derived neurotropic factor (BDNF) or VEGF and other growth factors while simultaneously germicidally attacking the degenerative tissue or infectious bacteria at the wound site.

[00159] The underlying principle of these pressure pulse or shock wave therapy methods is to enrich the treatment area directly and to stimulate the body's own natural healing capability. This is accomplished by deploying shock waves to stimulate strong cells in the surrounding tissue to activate a variety of responses. 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 treatment site, 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.

[00160] In the case of nerve trauma, Peter Wehling of Germany in US patent 5, 173,295 which is being incorporated herein by reference in its entirety, recites the conventional techniques for nerve repair, portions of which are recited below.

[00161] The purpose of all nerve repair techniques is to restore continuity of the nerve trunk, including all its elements, in order to achieve optimal reinnervation of the end organs. According to Millesi and Terzis (1984). the four basic steps of nerve repair can be defined as: 1. Preparation of the stumps, often involving resection or interfascicular dissection with separation of individual fascicles or groups of fascicles.

2. Approximation, with special reference to the length of the gap between the stumps as well as the amount of tension present.

3. Co-aptation of the nerve stumps. Co-aptation describes the opposition of corresponding nerve ends with special attention to bringing the cross-section of the fascicles into optimal contact. A direct co-aptation (neurorrhaphy) can oppose stump to stump, fascicle to fascicle, or fascicle group to fascicle group in the corresponding ends. An indirect co-aptation can be performed by interposing a nerve graft.

4. Maintenance of co-aptation, involving the use of, for example, stitches glue or a natural fibrin clot as glue.

[00162] Epineural Repair: Co-aptation of the nerve stumps by suturing the external epineurium is a classic method of nerve repair (Zachary & Holmes, 1946; Zachary, 1954; Edshage, 1964; Moberg, 1964; Braun, 1980; Snyder, 1981 ; Wilgis, 1982). An important step is the initial debridement of the nerve edges, which can be carried out by the use of soft membranous material wrapped circumferentially around the nerve to make the end firm enough to be cut with a scalpel or a pair of scissors. Cooling of the end has been used clinically (Edshage & Niebauer, 1966) and experimentally (de Medinaceli et al., 1983) to ensure sharp resection surfaces and facilitate the co-aptation. If the nerve has been sharply cut by the damage (glass, knife), there is usually no reason for further debridement before the repair is performed. The cut surface of the nerve may show protrusion of fascicular contents; if not too extensive, this should be accepted in order to avoid further trauma. Landmarks such as longitudinal epineural blood vessels are identified to ensure a correct rotation of the nerve stumps, and the fascicural pattern of the cut ends should be identified under high magnification, to further ensure correct matching of the ends when the suture is performed. The sutures are placed circumferentially in the epineurium of both stumps, initially at points where external landmarks make the correct rotation crystal clear. Further stitches are then placed around the circumference to secure and maintain the initial orientation. Due to postoperative edema, the nerve ends swell considerably during the first few days, and if the sutures are too tight the ends will be strangulated. It is therefore important to make the sutures very loose. The number of sutures should be as few as possible, and no more than are needed to hold the ends close enough together with sufficient strength.

[00163] The advantage of the epineural suture technique is its simplicity and the minimal dissection trauma required however, the technique does not ensure an absolutely correct matching of the fascicular structures over the nerve trunk. It was demonstrated by Edshage (1964) that the epineural suture technique may cause misalignment and considerable displacement of fascicles in spite of a perfect superficial appearance of the epineural adaptation. [00164] Fascicular Repair : The object of fascicular repair, or more correctly "group Fascicular repair" is to achieve an optimal orientation by approximating and adapting fascicles or groups of fascicles individually (Sunderland, 1981 ; Kurze, 1964; Smith, 1964; Bora, 1967; Hakstian, 1968; Grabb et al., 1970; Millesi, 1973; Cabaud et al., 1976, 1980; lto et al., 76; van Beek & Kleinert, 1977; Terzis & Strauch, 1978; Lilla et al., 1979; Terzis, 1979; Tupper, 1980; Kline et al., 1981 ; Kutz et ai., 1981 ). Fascicular groups are carefully freed by dissection under high magnification, and the epineural tissue is resected over a short distance from the cut nerve.

[00165] Corresponding fascicular structures in both cut nerve ends should be inspected under high magnification, and co-aptation with exact matching of the fascicular groups is accomplished by placing 9-0 or 10-0 sutures in the interfascicular epineurium. Co-aptation by placing suture material in the perineurial sheath of individual fascicles is associated with extensive dissection trauma and makes sense only in nerves with few fascicles. The risk of damaging fascicles should be realized . Sutures penetrating the perineurium might induce microherniation of endoneurial contents and may delay restoration of an optimal endoneurial environment.

[00166] With the introduction of microsurgical techniques, the fascicular repair technique became popular, and vast clinical experience has now been gained. The repair does not resist much tension, and can therefore usually be carried out only as a primary procedure when no resection is required. Its advantage is the possibility of ach ieving an optimal matching of corresponding fascicular components. Resection of epineural tissue serves to remove the most reactive connective tissue of the nerve and can facilitate the fascicular matching. However, resection of epineurium combined with separation of fascicular groups may induce considerable tissue trauma; including vascular injury and postoperative edema. The method has therefore the potential disadvantage of surgical trauma added to the original injury. Fascicular repair requires optical magnification and can be carried out only by a skilled and experienced microsurgeon.

[00167] Nerve Grafting: Direct suture of the ends of a severed or lacerated nerve is not always possible to perform. When a nerve transection is treated secondarily, it is normally necessary to resect a scarred area around the site of a lesion in order to achieve fresh resection surfaces. After this is done, the nerve ends cannot always be brought together without considerable tension. Advanced lesions, including damage to a segment of a nerve, may result in a gap in the continuity of the nerve trunk.

[00168] Although tension can to some extent be overcome by mobilization of the nerve ends and flexion of adjacent joints, it has become apparent over recent years that tension at a suture line is disadvantageous for axonal growth. Even a slight tension can interfere with intraneural microvascular flow, compromising the nutrition of cellular components in both nerve ends. It has also been demonstrated that tension at the suture line increases scar tissue formation and decreases the quality of axonal regeneration (Millesi et al., 1972a; 1976; Samii & Wallenberg, 1972; Orgel & Terzis, 1977; Miyamoto & Tsuge, 1981a; b; Millesi & Meissl, 1981). Tension reduces the transsectional area of the fascicles, thereby increasing normal endoneurial fluid pressure, on the other hand, minimal tension is not necessarily disadvantageous to axonal growth since such directed mechanical "microforces" might help to create longitudinal polarization of the fibrin clot occurring between two cut nerve ends, thus providing contact guidance for the advancing sprouts. In chamber experiments where a gap is left between the nerve ends, contractile forces in the fibrin clot contribute to the creation of a longitudinally-oriented stroma guiding axons growing toward the distal nerve segment.

[00169] Since experimental and clinical experience show that too much tension at the suture line is disadvantageous for axonal regrowth, most authors today prefer to avoid tension by bridging the gap with nerve grafts. Although this procedure has created new opportunities to achieve functionally good results even in severe nerve injuries (Millesi, 1977, 198Oy 1984; Millesi et al., 1972b, 1976; Wilgis, 1982), not all authors agree on the critical length of the defect which should indicate the use of a nerve graft. At a panel discussion on this subject (Millesi, 1977). the opinions varied from 1.5 to 2 cm (Brunelli, Freilinger, Samii, Buck-Gramcko) to 4 mm (Kutz & Wilgis) and 6-7 cm (Urbaniak & Gaul).

[00170] Regeneration through nerve grafts has been studied experimentally in rabbits (Hudson et al., 1972) and rats (Miyamoto et al., 1981 ; Lundborg et al., 1982; MacKinnon, 1986). Extensive compartmentation has been observed at both the proximal and distal anastamoses (Hudson et al., 1972) and along the body of the graft (MacKinnon, 1986). Extrafascicular fibers have been observed growing in the epineuirium of the graft along its whole length (4 cm in rats) (MacKinnon, 1986). Although fiber counts suggested that these fibers never made functional connections. By 4 to 6 months postoperatively, the total number of fibers in the proximal segment had become constant, while there was still an increased number of smaller diameter fibers in the graft and distal segments More fibers were present in the graft than in the distal segment indicating axonal branching at the first suture line and actual loss of fibers at the second suture line. No correlation was found between length of graft (rat peroneal nerve- length up to 2.5 cm) and number/maturation of regenerating fibers (M iyamoto et al., 1981 ). [00171 ] Survival of Graft: The purpose of introducing grafts between the two ends of a cut nerve is to offer mechanical guidelines as well as an optimal environment for the advancing sprouts. In this respects the Schwann cells of the grafts and their basal laminae play an essential role. Lamin in, located in the basal lamina of Schwann cells, is known to promote neurite growth and there are reasons to believe that certain proteins synthesized by the Schwann cells exert a neuronotrophic effect. If a thin nerve graft is placed in a healthy well vascularized bed, it will survive and will be able to fulfill this purpose. It has been demonstrated by isotope techniques that most transplanted Schwann cells in such a situation survive, multiply, form Bungner bands and remain confined to the grafted segment (Aguayo et al., 1976a, b, 1979; Charron et al., 1976; .Aguayo & Bray, 1980; Aguayo, 1981). During the first day the graft survives by diffusion from the surrounding tissu es. It is then revascularized rapidly, starting on the third postoperative day (Almgren, 1974). Thicker grafts have difficulties in surviving because of longer diffusion distances and delayed revascularization. The so-called "trunk graft" used in the past (for historical review, see Wilgis, 1982) usually showed a central necrosis because of its thickness.

[00172] Interfascicular Nerve Grafts: Millesi and his colleagues have shown that a gap in continuity in a nerve trunk is best treated with interfascicular nerve grafts performed with the aid of microsurgical techniques (Millesi et al., 1972b, 1976). The technical details of this procedure have been described in many excellent reviews (Millesi et al., 1972a, 1976; Millesi, 1977v 1980, 1981a, b. 1984; Wilgis, 1982). It is usually performed as a secondary procedure at a time when both the retracted nerve ends may be united by abandoned scar formations. Briefly, the dissection procedure is performed from normal to abnormal tissues. The epineurium is incised to make possible the identification of groups of fascicles. Separate groups are dissected free and traced towards the site of injury. At the point where the fascicles lose their normal appearance and run into thie neuroma, the group is transected. The epineurium is excised over a distance of 1-1.5 cm from the resection borders. In order to avoid a circumferential scar; each fascicular group should be transected at a different level.

[00173] The transsectional surfaces are studied under high magnification, and the patterns are mapped in order to identify corresponding fascicular groups. This process may be associated with considerable problems since the fascicular pattern of a nerve changes continuously along the medial course of the nerve. Moreover, the fascicular pattern of the graft does not correspond to the fascicular pattern of thie nerve ends. [00174] In nerves with fascicles arranged in groups, corresponding fascicle groups should be united by individual nerve grafts (interfascicular nerve grafts). In polyfascicular nerves without group arrangement, the fascicles may be distributed diffusely over the cross-sectional area, an arrangement which i s particularly common proximally at the root level or the brachial plexus. In such cases, each sector of the cross-section should be covered by a nerve graft until the whole cross-section is complete, so-called sectoral nerve grafting (Millesi, 1980).

[00175] Source of Nerve Graft: The most common choice is the sural nerve, which has an appropriate thickness and which can be harvested in considerable lengths from both lower limbs. The sural nerve has a varying pattern ranging from monofascicular to polyfascicular, and only a few branches (millesi, 1981 b). other suitable choices are the lateral or medial antebrachial cutaneous nerves (McFarlane & Myers, 1976). The terminal parts of the posterior interosseous nerves have been used as a graft in terminal lesion of digital nerves (Wilgis & Maxwell, 1979). In rarer instances, the superficial radial or lateral femoral cutaneous nerves can be used. The graft should be reserved to avoid loss of axons through branchings (Ansselin & Davey, 1986).

[00176] According to the concept of grafting, no tension at all should be tolerated at the suture lines between the graft and host nerves. The aptation could therefore be maintained by only one or two stitches of very tiny suture material (e.g., 10-0 nylon) and even fibrin clotting may be sufficient to maintain the co-aptation if tension is completely avoided (Millesi, 1980; Futami et al , 1983; Kuderna, 1985).

[00177] A problem can sometimes occur at the distal suture line where scar formation may present an obstacle to the advance of the axonal sprouts.

[00178] Free Vascularized Nerve Grafts : It is known from experimental studies that single segmental extrinsic vessels approaching a nerve trunk can maintain the intrinsic microcirculation in the nerve over long distances. It is tempting to apply this to microvascular techniques and insert free vascularized nerve grafts in gaps in nerve continuity: if the recipient bed is heavily scarred, a conventional non-vascularized nerve graft may not be optimally vascularized. In experiments on rats, the number and average diameter of regenerating axons has been found to be greater in vascularized nerve grafts than in free non-vascularized grafts CKoshima & Harii, 1981), and regenerating axons have been reported to grow at considerably greater speed in vascu larized nerve grafts than in free nerve grafts

(Koshima et al., 1981 ).

[00179] The concept of vascularized nerve grafts was introduced by Taylor and Ham (1976) and the technique has more recently been described by, among others, Breidenbach and Terzis (1984, 1987), Boney et al. (1984). and

Gilbert (1984). Five cases of segmental vascularized nerve grafts bridging scarred beds for digital sensory nerve reconstruction where previous non-vascularized nerve grafts had failed Λvere reported by Rose and Kowalski

(1985). They reported good recovery of sensibility, including average static two-point discrimination of around 9 mm.

[00180] Because of the expense, time and technical expertise required, vascularized nerve grafts must be reserved for very special occasions, primarily cases where normal revascularization of the grafts cannot be expected to take place. Among other possible advantages of vascularized nerve grafts used in a scarred recipient bed might be their ability to act as vascular carriers of non-vascularized nerve graft (Breidenbach & Terzis, 1984).

[00181] Nerve Lesion in Continuity : Peripheral nerve lesions with preserved continuity of the nerve trunk but loss of distal function to varying extents constitute one of the greatest challenges in peripheral nerve surgery. Such partial loss of function might result from subtotal nerve transections, blunt nerve trauma or traction injuries. Various fiber components of the nerve trunk can, in such cases, present all stages from simple neurapraxia (Sunderland grade 1 ) to neurotmesis (Sunderland grades 3-5). While some axons may be transected or ruptured, others may be compressed by interneural scar or compromised by vascular insufficiency. The approach to this type of injury, also called "neuroma in continuity" is extremely difficult. In these cases the surgeon may supply collagenase to the zone of injury, in accordance with the present invention. Surgical exploration, including neurolysis or resection and reconstruction, might also be indicated if the permanent situation cannot be accepted. In such cases, applying collagenase at the point of surgical intervention facilitates nerve regeneration.

[00182] The surgeon, if experienced with the type of lesion, may by inspection under high magnification be able to gauge to some extent which fascicles are healthy and should be spared and which are damaged and should be resected and replaced. However, with this method the findings can often be misleading and methods for intraoperative assessment of fiber function with electrophysiological recording techniques have been developed. Kl ine et al. ( 1968, 19691 1972) introduced techniques for intraoperative neurophysio logical assessment of the extent of the lesion by stimulating and recording from whole nerves With the development of microsurgical techniques, more refined methods for stimulation and recording from individual fascicles or fascicular groups became available. Hakstian ( 1968) introduced a method of stimulating motor and sensory fascicles separately in the proximal and distal nerve segments to improve accuracy in experimental nerve suture, and similar techniques have long been utilized to assess the quality of nerve regeneration following various types of nerve repair (Terzis et al., 1975, 1976; Terzis & Williams, 1976).

[00183] On the basis of these investigations, single fascicular recordings have been s uccessfully used as an intraoperative diagnostic tool in microsurgical repair of nerve lesions in continuity (Kline & Nulsen, 1972; Williams & Terzis, 1976; Kline, 1980; Terzis et al., 1980). According to these principles, single fascicles or, if that is not possible, groups of fascicles are freed by dissection and isolated proximal and distal to the lesion Each individual fascicle is lifted onto stimulating and recording electrodes, electrical stimuli are delivered proximally and a nerve compound action potential (CAP) is recorded distally to the lesion. On the basis of the conduction velocity as well as the shape and amplitude of the wave form, the degree of nerve injury can be assessed and a decision made regarding the treatment of the fascicle. If there is a measurable response, intraneural neurolysis might be justified while absence of any response might indicate resection and grafting of the damaged fascicle. [00184] The present invention can be used in combination with each of these nerve repair techniques and exposure to such pressure pulses or shock waves greatly accelerate the nerve repair healing time which accordingly enhances the likelihood of successful recovery of nerve function.

[00185] In clinical rat studies the remarkable re-growth of cut sciatic nerves has been demonstrated. The study involved cutting about 1.5 cm of the sciatic nerve, turning it 180° and suturing the cut ends back to the nerve (this model represents a nerve graft), closing the skin, followed by localized treatment using the present invention technology Co-inventor, Dr. Wolfgang Schaden, found that the nerves reattached/regenerated themselves better in cases where shock waves were applied. In addition, it was found that treated rats had a higher concentration of a certain protein in the brain that is common with well trained rats (i.e. rats undergoing physiotherapy). [00186] The trial was a 3 tailed study: 1st group of rats; dissection of the sciatic nerve and immediate microsurgical suture of the nerve. This was the control group. 2nd group: this group had the same procedure but after suturing the skin immediately Shockwaves were applied. 3rd group: resection of 1.5 cm of the sciatic nerve and microsurgical suture upside-down (nerve graft model). After suturing the skin immediately Shockwave therapy. Till now we have the following results: Group 1 had the expected results of sutured nerves (compared to historical study groups). Group 2 and even group 3 were clinically better than group 1. Group 2 and 3 were also better in electromyographical examinations. Both Shockwave groups had significant higher levels of BDNF as the control group, but even higher levels than trained rats (based on historical comparison to trials that have been previously performed).

[00187] Dr. Robert Schmidhammer who performed the nerve trials in Austria found the protein he could prove to be produced in the brain of the rats of the shock wave therapy is called brain derived neurotropic factor (BDNF). The concentration of this protein in the shock wave treated rats was even higher than in trained rats. [00188] These studies relied on the stimulation of the rats own natural healing ability after exposure to a shock wave treatment. The control group of rats had generally a failure to reattach and as expected no return of nerve function. This exposure to shock waves enhancing the neurological brain activity in the treated rats proves the overall systemic response of the nervous system to regenerative growth and repair after shock wave exposure at least on lower mammals such as rats.

[00189] This finding has led to the projected use of such treatments on humans for regenerative repair of degenerative conditions, the clinical studies so far indicating the same improvements can be anticipated in primates including humans.

[00190] Accepting the biological model as promoted by W. Schaden, the peak pressure and the energy density of the shock waves can be lowered dramatically. Activation of the body's healing mechanisms will be seen by in growth of new blood vessels and the release of growth factors.

[00191] The biological model motivated the design of sources with low pressure amplitudes and energy densities. First: spherical waves generated between two tips of an electrode; and second: nearly even waves generated by generalized parabolic reflectors. Third: divergent shock front characteristics are generated by an ellipsoid behind F2. Unfocused sources are preferab ly designed for extended two dimensional areas/volumes like skin. The unfocused sources can provide a divergent wave pattern a planar or a nearly planar wave pattern and can be used in isolation or in combination with focused wave patterns yielding to an improved therapeutic treatment capability that is non-invasive with few if any disadvantageous contraindications. Alternatively a focused wave emitting treatment may be used wherein the focal point extends preferably beyond the target treatment site, potentially external to the patient. This results in the reduction of or elimination of a localized intensity zone with associated noticeable pain effect while providing a wide or enlarged treatment volume at a variety of depths more closely associated with high energy focused wave treatment. Trie utilization of a diffuser type lens or a shifted far-sighted focal point for the ellipsoidal reflector enables the spreading of the wave energy to effectively create a convergent but off target focal point. This insures less tissue trauma while insuring cellular stimulation to enhance the healing process and control the migration or spreading of the infection within the host

[00192] The unfocused shock waves can be of a divergent wave pattern, planar or near planar pattern preferably convergent diffused or far-sighted wave pattern, of a low peak pressure amplitude and density. Typically the energy density values range as low as 0.000001 mJ/mm² and having a high end energy density of below 1.0 mJ/mnr, preferably 0.20 mJ/mm² or less. The peak pressure amplitude of the positive part of the cycle should be above 1.0 and its duration is below 1 -3 microseconds. [00193] The treatment depth can vary from the surface to the full depth of the treated organ. The treatment site can be defined by a much larger treatment area than the 0.10 - 3.0 cnr commonly produced by focused waves. The above methodology is particularly well suited for surface as well as sub-surfa.ce soft tissue organ treatments like the brain.

[00194] The above methodology is valuable in generation of nerve tissue, vascularization and may be used in combination with stem cell therapies as well as regeneration of damaged nerve or neurological tissue and vascularization.

[00195] The methodology is useful in (re)vascularization and regeneration o f not only neurological tissue such as the brain, but also the heart, liver, kidney, skin, urological organs, reproducti ^■ve organs and digestive tract. [00196] The methodology is useful in stimulating enforcement of defense mechanisms in tissue cells to fight infections from bacteria and can be used germicidal Iy to treat or cleanse wounds or other infected or degenerative target sites which is a primary concern in the case of treating human neurological diseases such as Alzheimer's disease, Parkinson's or ALS, resulting from such exposures to infectious or degenerative type agents. [00197] While the above listed indications cited above are not exhaustive nor intended to be limiting, it is exemplary of the wide range of beneficial uses of high energy focused or low energy and amplitude unfocused divergent, planar or nearly planar shock waves, convergent shock waves, diffused shock waves or a combination of shock wave types in the treatment of humans and other mammals that are ex.posed to a neurological trauma or disease affecting the nervous system or are at high risk to be so exposed as tine result of a high potential genetic pre¬ disposition to such diseases.

[00198] A most significant method of preventive medicine can be practiced that is fully enabled by the use of these relatively low amplitude and pressure shock waves. The method includes tri e steps of identifying high risk patients for a variety of potential risk conditions. Such condition could be by way of example, any degenerative neurological disease or loss of feeling or circulation in a target region. After identifying a risk prone candidate providing one or a series of two or more exposure treatments with focused or unfocused, divergent, planar or near planar shock waves or convergent far-sighted focused shock waves or diffused shock waves to the treatment site, in this example the region surrounding or in proximity to an occurrence risk location. Then after treatments the physician can optionally ultrasound visually or otherwise determine the increase in regeneration or vascularization in the treated tissue after a period of time. Assuming an initial baseline determination of the neurological cell or nerve tissue regeneration or vascularization had been initially conducted an estimate or calculation of dosage requirements can be made. This procedure can be used for any at risk condition. After a surgical repair procedure the surrounding tissues can be post-operative Iy shock wave treated as well.

[00199] The implications of using the (re)generative features of this type of shock wave therapy are any weakened organ or tissue can be strengthened to the point of reducing or eliminating ttie risk of irreparable damage or failure as a result of microbial infections or genetic pre-disposition.

[00200] The stimulation of growth factors and activation of healing acceleration within the cells of the treated tissues is particularly valuable to host patients and other high risk factor subjects wherein conventional treatments have been unsuccessful.

[00201] Even more striking as mentioned earlier, early prevention therapies can be employed to stimulate tissue or organ modeling to be maintained within acceptable ranges prior to an exposure to a degenerative failure. This is extremely valuable in the prevention of spreading the infection or degenerative condition for example. The methods would be to identify at risk patients with a known exposure risk, and subjecting that patient to therapeutic shock wave therapy for the purpose of stimulating neurological tissue repair or regeneration effectively remodeling the patient's susceptible organs to be within accepted functional parameters prior to irreparable degeneration. The objective being to preventively stimulate cellular tissue repairs to preemptively avoid a degenerative condition from occurring which may result in the onset of a degenerative condition which can require invasive surgical procedures. [00202] This preventive therapy is most needed to combat condit ions which left untreated results in cellular destruction or any other degenerative conditions.

[00203] The treatment of the above mentioned tissue, organ or body of a patient is believed to be a first time use of acoustic shock wave therapy in the preventive pre-exposure or post-exposure to neurological tissues or organs or nerve damage or degeneration of said tissues or organs. None of the work done to date has treated the above mentioned treatments with convergent, divergent, planar or near-planar acoustic unfocused shock waves of low energy or high energy focused shock waves in a germicidal transmission path from the emitting source lens or cover to the infection or target site. Also this is believed to be a first time use of acoustic shock waves for germicidal wound cleaning or preventive medical treatments for such exposures after nerve or brain trauma. The use of the methods of the present invention are particularly useful in the reattachment of severed limbs and tissue. It is hoped that the use of the present invention will reduce the number of cases of amputations in severe injury cases. [00204] It will be appreciated that the apparatuses and processes of the present invention can have a variety of embodiments, only a few of which are disclosed herein. It will be apparent to the artisan that other embodiments exist and do not depart from the spirit of the invention. Thus, the described embodiments are illustrative and should not be construed as restrictive.

[00205] The use of acoustic shock waves to patients exposed to neurological infections or nerve trauma stimulates a cellular response of the treated tissues as well as a cellular response in the surrounding tissue. This response activates otherwise dormant cells to increase the body's own defense mechanisms, allowing the cells to limit the migration of the infection and resultant tissue damage, but also to initiate the healing process. This feature means that the treating physician has the added benefit of a patient whose body will be strengthened to mitigate damage to otherwise healthy tissues and organs.

[00206] A seventh embodiment of the present invention relates to the use of various pressure pulse wave patterns or acoustic shock wave patterns as illustrated in figures 1 - 12 far stimulating plant growth. 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 effort to accelerate plant growth and production. [00207] The present invention employs the use of pressure pulses or shock waves to stimulate a cellular response stimulating a tissue growth process that activates the tissue to initiate a systemic growth process. [00208] In the pressure pulse or shock wave method of treating a plant tissue, a zygotic embryo or seed or somatic embryos of the plant or cultures of such embryos are positioned in a convenient orientation to permit the source of the emitted waves to most directly send the waves to the target s ite to initiate pressure pulse or shock wave stimulation of the target area or zone with minimal, preferably with little or no obstructing features in the path of the emitting source or lens. Assuming the treatment region is access ible through an open access region then the shock wave head 43 can be inserted and placed directly on or adjacent to the treatment region 300. Assuming the target area or site is within a projected area of the wave transmission, a single transmission dosage of wave energy may be used. 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.O0001 mJ/mm² to 1.0 mJ/mm² or less, most typically below 0.2 mJ/mm². 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 tissue target site is disposed pre-convergence inward of the geometric focal point of the emitted wave transmission. In treating some hard to penetrate regions, the pressure pulse more preferably is a high energy target focused wave pattern which can effectively penetrate through outer structures prior to being dampened while still exposing the plant to activating pressure pulses or shock waves. This emitted energy preferably stimulates the plant cells without rupturing cellular membranes. The surrounding healthy cells in the region treated are activated initiating a growth mechanism response stimulating new groΛvth. In the case of embryonic tissues, the cells are activated stimulating accelerated germination when planted in a nutrient rich environment such as soil.

[002O9] These shock wave energy transmissions are effective in stimulating a cellular response and can be accomplished without creating the cavitation bubbles in the tissue of the target site when employed in other than site targeted high energy focused transmissions. This effectively insures the tissue or plant does not have to experience the sensation of cellular membrane rupturing so common in the higher energy focused wave forms having a focal point at or within the targeted treatment site.

[002 10] This method permits the lens or cover of the emitting shock wave source to impinge on the plant or tissue directly or through a transmission enhancing gel, water or fluid medium during the pressure pulse or shock wave treatment. The treated area can withstand a far greater number of shock waves based on the selected energy level being emitted. For example at very low energy levels the stimulation exposure can be provided over prolonged periods as much as 20 minutes if so desired. At higher energy levels the treatment duration can be shortened to less than a minute, less than a second if so desired. The limiting factor in the selected treatment dosage is avoidance or minimization of surrounding cell rupturing and other kinds of damage to the surrounding cells or tissue while still providing a stimulating cell activation or a cellular release or activation of proteins or functional fragments of the protein or other chemical composition that modulates growth factors.

[002 1 1] The underlying principle of these pressure pulse or shock wave therapy methods is to enrich the treatment area directly and to stimulate the plant's own natural growth capability. This is accomplished by deploying shock waves to stimulate cells in the surrounding tissue to activate a variety of responses. 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 treatment site, 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 growth reactions. The treatment is particularly beneficial in early stages of plant growth, but also can foe employed with appropriate transmission medias to treat infected or damaged mature plants such as infected trees which when subjected to shock waves activates a cel lular defense response to an intrusion of for example parasitic diseases. [00212] Ideally the present invention is best suited for large scale farming and nursery operations where seedlings are harvested in large quantities.

[00213] As shown in Figure 21 the treated plant tissue can be seeds, zygotic embryos, or somatic embryogenesis cells placed in a nutrient rich environment or culture medium which easily allows the transmitted waves to pass through each seed or cluster of embryogenic cells to trigger the growth protein modulation. Thereafter the treated plant tissues can be planted in soil or nutrient medium to initiate root generation and full germination. [00214] In practice treated bean seeds were planted along with untreated control seeds. The treated seeds sprouted on average two days before the control seeds. This finding is consistent with the findings of a Canadian patent 2,376,695 which used an array of magnets to produce a magnetic field in proximity to the planted seeds. The distinction and benefit of the present invention is the treatment is applied one time to a mass quantity of seeds prior to planting. The cellular stimulation having been triggered no further stimulation was required . The vegetative foliage of the treated bean plants was superior in growth and appearance as well evidencing a pronounced long-term benefit.

[00215] Additional shelf life testing needs to be conducted to see if the effect of shock waves is transitory. That is how long treated seeds, embryos or seedlings can be held in storage until planting and still see the beneficial accelerated germination and improved quality of plant structure.

[00216] As further shown in Figure 21 the pressure pulse or shock wave head 43 can be immersed in a nutrient rich fluid medium or culture 120 of zygotic embryos, seeds or somatic embryos or embryonic tissues 100. The treated tissue 100 can be one or more such embryo or seeds 100, preferably many more. As shown a large container or vat 1 10 is shown holding many thousands of such plant tissues 100 to comprise the treatment volume 300. The shock wave head 43 is connected via cabling 42 base to a wave generator or source (not illustrated). After treating the plant tissue or seeds 100 the treated embryonic plants can be potted or planted to initiate the germination process. As can be appreciated such a process is also ideally suited for hydroponic planting processes a_s well. The treated plant tissues can form trees, bushes, tubers, cotton, or vegetables like soybean, corn, peanuts, beans, melons, citrus fruit trees, avocados or any other plants including grasses. The plants may be of flowering varieties or seed producing varieties such as walnut, pecan and other tree born nut producing plants. The resultant treated plant tissue may be of a plant variety which is used in manufacture of medicines or other pharmaceutical drugs. The treatment may be directed to the root system and stimulation thereof or the leaf system or stern. The treated tissue may be at a graft site or may be plant tissue of one or more zygotic embryos or one or more somatic embryos which is micro-propagated from somatic embryo in vitro from minute pieces of tissue or individual cells such as in cloning.

[00217] Assuming the treated seeds need not be potted or planted immediately then the above method could have an important role in large scale seed production. Otherwise the beneficial attributes may be better suited for nurseries and large scale planting operations wherein improved plant growth rates are financially rewarding. [00218] Nevertheless the use of such pressure pulses and acoustic shock waves can be very beneficial to plant production in terms of accelerated growth. [00219] As shown in Figures 1 - 12 the use of these various acoustic shock wave forms can be used separately or in combination to achieve the desired effect of stimulating growth.

[00220] Furthermore such acoustic shock wave forms can be used in combination with chemical treatments, gene therapy or cloning or plant grafting or cross pollination methods and when so combined the stimulated cells will more rapidly grow increasing productivity and potentially improving yields.

[00221] The present invention provides an apparatus for an effective treatment of plant tissues, 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 cellular membrane damage do not exist at all.

[00222] In certain embodiments, the apparatus of the present invention is able to produce waves having energy density values that are below 0.1 mJ/mm2 or even as low as 0.000 001 mJ/mm2. In a preferred embodiment, those low end values range between 0.1 - 0.001 mJ/mm2. With these low energy densities, side effects are reduced and the dose application is much more uniform. Additionally, the possibility of harming surface tissue is reduced when using an apparatus of the present invention that generates unfocused waves having planar, nearly plane, convergent or divergent characteristics and larger transmission areas compared to apparatuses using a focused shock wave source that need to be moved around to cover the treated area. 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.

[00223] The treatment of the above mentioned plant tissue or body of a plant is believed to be a first time use of acoustic shock wave therapy. None of the work done to date has treated the above mentioned plant treatments with convergent, divergent, planar or near-planar acoustic unfocused shock waves of low energy or high energy focused shock waves in a transmission path from the em itting source lens or cover to the target site.

[00224] The use of acoustic shock waves to plant tissue stimulates a cellular response of the treated tissues as -well as a cellular response in any surrounding tissue. This response activates otherwise dormant cells to increase the plant's growth mechanisms, allowing the cells to rapidly replicate to initiate the growth process.

[00225] A further benefit of the use of acoustic shock waves is there are no known adverse indications when combined with the use of other nutrients. In fact the activation of the cells exposed to shock wave treatments only enhances cellular absorption of such nutrients making them faster acting than when compared to non stimulated cells. As a result, it is envisioned that the use of one or more nutrients prior to, during or after subjecting the plant tissue to acoustic shock waves will be complimentary to the treatment or pre-conditioning treatment. It is further appreciated that certain uses of pesticides can be altered or modified to lower risk or adverse side effects when combined with a treatment involving acoustic shock waves as described above.

[00226] Another aspect of the present invention is the use of acoustic shock waves can be combined with organic food farming. The treatment does not require genetic alteration or manipulation to accelerate the otherwise natural growth of plant tissue as such the use of acoustic shock waves is compatible with organic farming practices as well as the new fields of genetic engineering.

[00227] In an eighth embodiment of the present invention relates to the use of various pressure pulse wave patterns or acoustic shock wave patterns as illustrated in figures 1 - 12 for stimulating or enhancing aquatic growth of life forms such as fish or shellfish species. 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 effort to accelerate fish and shellfish growth and production.

[00228] The present invention employs the use of pressure pulses or shock waves to stimulate a cellular response stimulating a tissue growth process that activates the tissue to initiate a systemic growth process in the treated specimen.

[00229] In the pressure pulse or shock wave method of treating an aquatic tissue, a zygotic embryo or somatic embryos or cultures of such embryos or larvae or immature, or partially mature aquatic life forms are positioned in a convenient orientation to permit the source of the emitted waves to most directly send the waves to the target site to initiate pressure pulse or shock wave stimulation of the target area or zone with minimal, preferably with little or no obstructing features in the path of the emitting source or lens. Assuming the treatment region is accessible through an open access region then the shock wave head 43 can be inserted and placed directly in the treatment region 200. Assuming the target area or site is within a projected area of the wave transmission, a single transmission dosage of wave energy may be used. 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/mm² to 1.0 rnJ/mm² or less, most typically below 0.2 mJ/mm². 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 aquatic 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 tissue target site is disposed pre- convergence inward of the geometric focal point of the emitted wave transmission. In treating some hard to penetrate regions, the pressure pulse more preferably is a high energy target focused wave pattern which can effectively penetrate through outer structures prior to being dampened while still exposing the aquatic tissue to activating pressure pulses or shock waves. This emitted energy preferably stimulates the cells without rupturing cellular membranes. The surrounding healthy cells in the region treated are activated initiating a growth mechanism response stimulating new growth. In the case of embryonic tissues, the cells are activated stimulating accelerated growth when cultured in a nutrient rich water environment such as plankton enriched water. [00230] These shock wave energy transmissions are effective in stimulating a cellular response and can be accomplished without creating the cavitation bubbles in the tissue of the target site when employed in other than site targeted high energy focused transmissions. This effectively insures the tissue of the fish or shellfish does not have to experience the sensation of cellular membrane rupturing so common in the higher energy focused wave forms having a focal point at or within the targeted treatment site.

[00231] This method permits the lens or cover of the emitting shock wave source to impinge on the aquatic tissue directly or through a transmission enhancing gel, water or fluid medium during the pressure pulse or shock wave treatment. The treated area can withstand a far greater number of shock waves based on the selected energy level being emitted. For example at very low energy levels the stimulation exposure can be provided over prolonged periods as much as 20 minutes if so desired. At higher energy levels the treatment duration can be shortened to less than a minute, less than a second if so desired. The limiting factor in the selected treatment dosage is avoidance or minimization of surrounding cell rupturing and other kinds of damage to the surrounding cells or tissue while still providing a stimulating cell activation or a cellular release or activation of proteins or functional fragments of the protein or other chemical composition that modulates growth factors.

[00232] The underlying principle of these pressure pulse or shock wave therapy methods is to enrich the treatment area directly and to stimulate the aquatic tissue's own natural growth capability. This is accomplished by deploying shock waves to stimulate cells in the surrounding tissue to activate a variety of responses. 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 treatment site, 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 growth reactions. The treatment is particularly beneficial in early stages of aquatic growth, but also can be employed with appropriate transmission medias to treat infected or damaged immature or mature specimens such as infected fish or shellfish which when subjected to shock waves activates a cellular defense response to an intrusion of for example parasitic diseases or viral infections.

[00233] Ideally the present invention is best suited for large scale fish farming and mariculturing or aquaculturing operations where fish and shellfish are harvested in large quantities.

[00234] As shown in Figure 21 the treated aquatic tissue can be zygotic embryos, or larvae or fry placed in large quantities in a nutrient rich environment or culture medium which easily allows the transmitted waves to pass through each egg or cluster of embryogenic cells on each life form to trigger the growth protein modulation. Thereafter the treated aquatic tissues can be placed in another nutrient rich medium to initiate accelerated full growth.

[00235] In practice treated plant specimen bean seeds were planted along with untreated control seeds. The treated seeds sprouted on average two days before the control seeds. This finding is consistent with the findings of a Canadian patent 2.376,695 which used an array of magnets to produce a magnetic field in proximity to the planted seeds. The distinction and benefit of the present invention is the treatment is applied one time to a mass quantity. The cellular stimulation having been triggered no further stimulation was required, the vegetative foliage of the treated bean plants was superior in growth and appearance as well evidencing a pronounced long-term benefit. Additionally mammals have demonstrated improved vascularization and accelerated tissue growth. Since aquatic life forms have a cellular structure the application of shock wave exposure is equally beneficial. [00236] As further shown in Figure 21 the pressure pulse or shock wave head 43 can be immersed in a nutrient rich fluid medium or culture 120 of zygotic embryos, eggs or larvae or other aquatic embryonic tissues or specimens 100. The treated tissue 100 can be one or more such embryo or eggs or specimens 100, preferably many more. As shown a large container or vat 1 10 is shown holding many thousands of such aquatic tissues 100 to comprise a treatment volume 300. The shock wave head 43 is connected via cabling 42 base to a wave generator or source (not illustrated). After treating the aquatic tissue or eggs 1OO the treated tissue can be released into larger holding tanks to initiate the growth process. As can be appreciated such a process is also ideally suited for salt water processes as well. The treated tissues can be selected from any variety of fish, shellfish or aquatic life form. The treated tissue may be tissue of one or more zygotic embryos or one or more somatic embryos which is micro-propagated from somatic embryo in vitro from minute pieces of tissue or individual cells such as in cloning.

[00237] Nevertheless the use of such pressure pulses and acoustic shock waves can be very beneficial to aquatic life form production in terms of accelerated growth.

[00238] As shown in Figures 1 - 12 the use of these various acoustic shock wave forms can be used separately or in combination to achieve the desired effect of stimulating growth.

[00239] Furthermore such acoustic Shock wave forms can be used in combination with chemical or drug treatments, gene therapy or cloning or vaccination or inducing tolerance methods and when so combined the stimulated cells will more rapidly grow increasing productivity and potentially improving yields.

[00240] The present invention provides an apparatus for an effective treatment of aquatic life form tissues, 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 cellular membrane damage do not exist at all.

[00241] In certain embodiments, the apparatus of the present invention is able to produce waves having energy density values that are below 0.1 mJ/mm2 or even as low as 0.000 001 mJ/mm2. In a preferred embodiment, those low end values range between 0.1 - 0.001 mJ/rnm2. With these low energy densities, side effects are reduced and the dose application is much more uniform. Additionally, the possibility of harming surface tissue is reduced when using an apparatus of the present invention that generates unfocused waves having planar, nearly plane, convergent or divergent characteristics and larger transmission areas compared to apparatuses using a focused shock wave source that need to be moved around to cover the treated area. 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.

[00242] The treatment of the above mentioned aquatic tissue or body of an aquatic life form is believed to be a first time use of acoustic shock wave therapy. None of the work done to date has treated the above mentioned life forms with convergent, divergent, planar or near-planar acoustic unfocused shock waves of low energy or high energy focused shock waves in a transmission path from the emitting source lens or cover to the target site for trie purpose of disease resistance or growth stimulation.

[00243] The use of acoustic shock waves to aquatic tissue stimulates a cellular response of the treated tissues as well as a cellular response in any surrounding tissue. This response activates otherwise dormant cells to increase the growth mechanisms, allowing the cells to rapidly replicate to initiate the growth process.

[00244] A further benefit of the use of acoustic shock waves is there are no known adverse indications when combined with the use of other nutrients. In fact the activation of the cells exposed to shock wave treatments only enhances cellular absorption of such nutrients making them faster acting than when compared to non stimulated cells. As a result, it is envisioned that the use of one or more nutrients prior to, during or after subjecting the tissue to acoustic shock waves will be complimentary to the treatment or pre-conditioning treatment. It is further appreciated that certain uses of vaccines or antibodies can be altered or modified to lower risk or adverse side effects when combined with a treatment involving acoustic shock waves as described above. [00245J Another aspect of the present invention is the use of acoustic shock waves can be combined with organic food farming. The treatment does not require genetic alteration or manipulation to accelerate the otherwise natural growth of aquatic tissue as such the use of acoustic shock waves is compatible with organic farming practices as well as the new fields of genetic engineering.

[00246] Contrary to the findings of Vago in US Patent Application Publication US 2005/0075587, the present invention has found a novel and unique way of providing pressure pulse and shock wave patterns that avoid the problem of cavitation and resultant cellular tissue damage when used in cleaning open wounds. Additionally the methods described above provide germicidal effects in the treated area that further minimize the spread of infection; as such the present invention is an appropriate treatment for the germicidal cleaning of wounds in aquatic life forms as well as mammals.

[00247] In the Extracorporeal Shock wave method of treating a mammal be it human or an animal with a known condition to be treated at a target site on the anatomy, the patient is placed in a convenient orientation to permit the source of the emitted waves to most directly send the waves to the target site to initiate shock wave stimulation of the target area. Assuming the target area is within a projected area of the wave transmission, a single transmission dosage of wave energy may be used.

[00248] The methodology is useful to treat pathological, post traumatical Iy, post operative or degenerative nerve damage via nerve (re)generation. In particular where the nerves are damaged the method of treating the damaged nerves within the tissue include subjecting the nerves to shock waves to heal, regenerate or find nerve ends. The patients in this type of therapy may have a mild indication of paraplegia involving some loss of feeling to severe indications such as partial or complete paralysis caused by severed nerves.

[00249] The methodology is useful to treat post operative, post traumatical Iy, or degenerative osteoarthritis via cartilage (re)generation.

[00250] The methodology is useful in skin (re)generation to treat venous, arterial, diabetic, decubital, post operative, post traumatically or post burning.

[00251] The methodology is useful in bone (re)generation to treat maxillary, mandible or skeletal system post operative, post traumatically or degenerative.

[00252] The methodology is useful in muscle or tendon (re)generation to treat pathological, post traumatically, post operative or degenerative.

[00253] The methodology is useful in (re)vascularization of organs in the heart, brain, liver, kidney and skin.

[00254] The methodology is useful in the treatment of cancer by stimulating healthy cells to attack the tumorous cell thereby inhibiting the spread of the cancer. When further combined with a focused shock wave therapy the tumorous growth or mass can be targeted and weakened cellularly followed by a stimulation of near proximity healthy cancer free cells to invasively destroy the tumor.

[00255] The methodology is useful in stimulating enforcement of defense mechanisms in tissue cells to fight infections from bacteria and can be used germicidally to treat or cleanse wounds or other target sites.

[00256] The methodology can be further used to correct pathological growth of the epiphyseal plate.

[00257] Conditions caused by cirrhosis of the liver can be treated by reversing this degenerative condition.

Similarly gum disease can be treated using the above methodology. [00258] The methodology lends itself to cosmetic uses in eliminating or reducing cellulitis, scartissue, acne, and skin smoothing as well as for stimulating hair growth.

[00259] While the above listed indications cited above are not exhaustive nor intended to be limiting, it is exemplary of the wide range of beneficial uses of low energy and amplitude unfocused divergent or nearly planar shock waves, convergent shock waves, diffused shock waves or a combination of shock wave types in the treatment of humans and other mammals.

[00260] While one of the benefits of the non-invasive nature of this treatment relates to reducing patient recovery and healing time, the fact that the treatments can be delivered at dosages well below the threshold of pain means that no local or general anesthesia is typically required as a consequence of the treatment. This al one significantly reduces any risk factors or complications associated with pain management during the procedure. The treatments further can reduce the need for a regiment of chemical or drug therapies before or after exposure to this shock wave therapy. Alternatively, ESWT can be used in conjunction with chemical or drug therapies to increase the cellular response permitting an opportunity to lower dosages of such chemicals or drugs while increasing the therapeutic efficiency. This is a particularly useful tool for the physician whose patient is elderly, a smoker or with an immune system deficiency which would complicate if not make unavailable more traditional invasive surgical procedures.

In fact the above methodology proposed in this patent may be the first if not only choice of treatment available for patients in this class wherein heretofore conventional procedures were deemed too risky.

[00261] A further clinical benefit of the above methodology is that the procedure can be done either as an outpatient treatment or at a doctor's office assuming the patient's condition does not otherwise re= quire hospitalization.

[00262] A most significant method of preventive medicine can be practiced that is fully enabled by the use of these relatively low amplitude and pressure shock waves. The method includes the steps of identifying high risk patients for a variety of potential conditions. Such condition could be by way of example heart disease caused by poor vascularization. After identifying a risk prone candidate providing one or a series of two or more; exposure treatments with unfocused, divergent or near planar shock waves or convergent far-sighted focus ed shock waves or diffused shock waves to the treatment site, in this example the heart. Then after treatments the pliysician can optionally ultrasound visually or otherwise determine the increase in vascularization after a period of time.

Assuming an initial baseline determination of the heart vascularization had been initially conducted an estimate or calculation of improved vascularization of the site can be made. This procedure can be used for any at risk condition.

[00263] The implications of using the (re)generative features of this type of shock wave therapy are any weakened organ or tissue even bone can be strengthened to the point of reducing or eliminating the risk of irreparable damage or failure.

[00264] The stimulation of growth factors and activation of healing acceleration is particularly v/aluable to elderly patients and other high risk factor subjects.

[00265] Additionally the ability to stimulate tissue, nerve and bone generation may find valuabl e uses in reattachment of limbs wherein post operative healing can be given a marked increase in successfully gaining full use of a reattached limb. Similar gains are visualized in organ transplant and complete organ regeneration. [00266] Even more striking as mentioned earlier, early prevention therapies can be employed to stimulate tissue or organ modeling to be maintained within acceptable ranges prior to a degeneration occurring. This is extremely valuable in the prevention of heart disease for example. The methods would be to identify at risk patients based on family history or genetic disposition, physical condition, etc. and subjecting that patient to therapeutic shock wave therapy for the purpose of stimulating tissue repair effectively remodeling the patient's susceptible organ to be within accepted functional parameters. The objective being to preventively stimulate cellular tissue repairs to preemptively avoid a degenerative condition from occurring which may require invasive surgical procedures. [00267] This preventive therapy is most needed to combat neurological degenerative conditions such as alzheimer's disease or brain trauma injuries. Kidney failure indications can similarly be pre-screened for susceptibility as well as the liver for cirrhosis and the heart for vascularization or any other degenerative condition . [00268] The use of the proposed shock wave therapy further can provide tremendous relief to burn victims. Shock wave treated skin tissue can be more rapidly regenerated or generated for skin grafting and the germicidal cleansing effect of low energy unfocused shock waves on the patient can help reduce the infection caused by the damaged tissue while promoting tissue attachment and healing of the grafted skin.

[00269] Applicants have applied this treatment therapy to cartilage and tendon orthoscopic repairs and have reduced the healing time from over 6 weeks to less than 2 weeks. These and other beneficial treatments are made possible by using an apparatus with a shock wave emission either singularly or in an array as described below in tine embodiments shown in figures 1 - 12.

[00270] The treatment of the above mentioned indications are believed to be a first time use of acoustic shock wave therapy generally with the exception of the heart and pancreas which have been subjected to tissue focal point targeted by focused shock waves. None of the work done to date has treated the above mentioned indications witln convergent, divergent, planar or near-planar acoustic shock waves of low energy. Accordingly the use of acoustic shock waves for treating such indications as cirrhosis of the liver, cancer, myelodysplasia, stomach ulcers, AIDs, Alzheimer's disease, bone cancer, arthritis, emphysema, gout, rheumatic disease, HfV, leprosy, lupus, skin sarcomas, cellulitis, melanomas, osteoporosis, periodontal diseases, pseudoarthrosis, wounds, scars, acne, burns, diabetes, cystic fibrosis, nerve paraplegia or enhancing stem cell reactions are completely new and a breakthrough in medical treatments of such diseases. As is the use of acoustic shock waves for germicidal wound cleaning or preventive medical treatments.

[00271 ] Fig 1 a is a simplified depiction of the a pressure pulse / shock wave (PP/S W) 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 diseased organ 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.

[00272] Figure I b 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 the patient's body 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

[00273J Figure Ic 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 1 1 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 Ic 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 The divergent characteristics of the wave front may be a consequence of the mechanical setup shown in Fig 2b

[00274] Figure 2a is a simplified depiction of a pressure pulse / shock wave generator (shock wave head) according to the present invention having an adjustable or exchangeable (collectively refeπed to herein as "movable") housing around the pressure wave path The apparatus is shown in a focusing position Fig 2a is similar to Fig I a but depicts an outer housing (16) in which the acoustical pathway (pressure wave path) is located In a preferred embodiment, this pathway is defined by especially treated water (for example, temperature controlled, conductivity and gas content adjusted water) and is within a water cushion or within a housing having a permeable membrane, which is acoustically favorable for the transmission of the acoustical pulses In certain embodiments, a complete outer housing (16) around the pressuie pulse/shock wave generator (1 ) may be adjusted by moving this housing (16) in relation to, e g , the focusing element in the generator However, as the person skilled in the art will appreciate, this is only one ot many embodiments of the present invention While the figure shows that the exit window (17) may be adjusted by a movement of the complete housing (16) relative to the focusing element, it is clear that a similar, if not the same, effect can be achieved by only moving the exit window, or, in the case of a water cushion, by filling more water in the volume between the focusing element and the cushion Fig 2a shows the situation in which the arrangement transmits focused pressure pulses

[00275] Figure 2b is a simplified depiction of the pressure pulse / shock wave geneiator (shock wave head) having an adjustable or exchangeable housing around the pressuie wave path with the exit window 17 being in the highest energy divergent position The configuration shown in Fig 2b can, for example, be generated by moving the housing (16) including the exit window (17), or only the exit window (17) of a water cushion, towards the right (as shown m the Figure) to the second focus f2 (20) of the acoustic waves In a preferred embodiment, the energy at the exit window will be maximal Behind the focal point, the waves may be moving with divergent characteristics (21) [00276] Figure 2c is a simplified depiction of the pressure pulse / shock wave generator (shock wave head) having an adjustable or exchangeable housing around the pressure wave path in a low energy divergent position The adjustable housing or water cushion is moved or expanded much beyond f2 position (20) so that highly divergent wave fronts with low energy density values are leaving the exit window (17) and may be coupled to a patient's body Thus, an appropriate adjustment can change the energy density of a wave front without changing its characteristic

[00277] This apparatus may, in certain embodiments, 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, nearly plane or diveigent characteristics can be chosen [00278] 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 pul se/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. [00279] In certain embodiments, the change of the distance of the exit acoustic window can be accomplished by a sliding movement. However, in other embodiments of the present invention, in particular, if mechanical complex arrangements, the movement can be an exchange of mechanical elements.

[00280] 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. [00281 ] In one embodiment, the apparatus of the present invention is used in combination therapy. 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. [00282] While the above described universal toolbox of the present invention provides versatility, the person skilled in the art will appreciate that apparatuses that only produce waves having, for example, nearly plane characteristics, are less mechanically demanding and fulfill the requirements of many users. [00283] As the person skilled in the art will also appreciate that embodiments shown in drawings I a-Ic and 2a-2c 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 patient 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.

[00284] Figure 3 is a simplified depiction of the pressure pulse / shock wave apparatus having no focusing reflector or other focusing element. The generated waves emanate from the apparatus without coming into contact with any focusing elements. Figure 3 shows, as an example, an electrode as a pressure pulse generating element producing divergent waves (28) behind the ignition point defined by a spark between the tips of the electrode (23, 24). [00285] Figure 4a is a simplified depiction of the pressure pulse / shock wave generator (shock wave head) having as focusing element an ellipsoid (30). Thus, the generated waves are focused at (6).

[00286] Figure 4b is a simplified depiction of the pressure pulse / shock wave generator (shock wave head) having as a focusing element an paraboloid (y²=2px). Thus, the characteristics of the Λvave fronts generated behind the exit window (33, 34, 35, and 36) are disturbed plane ("parallel"), the disturbance resulting from phenomena ranging from electrode burn down, spark ignition spatial variation to diffraction effects. However, other phenomena might contribute to the disturbance.

[00287] Figure 4c is a simplified depiction of the pressure pulse / shock wave generator (shock wave head) having as a focusing element a generalized paraboloid (yⁿ=2px, with l,2<n<2,8 and n ≠ 2). Thus, the characteristics of the wave fronts generated behind the exit window (37, 38, 39, and 40) are, compared to the wave fronts generated by a paraboloid (y²=2px), less disturbed, that is, nearly plane (or nearly parallel or nearly even (37, 38, 39, 40)). Thus, conformational adjustments of a regular paraboloid (y²=2px) to produce a generalized paraboloid can compensate for disturbances from, e.g., electrode burn down. Thus, in a generalized paraboloid, the characteristics of the wave front may be nearly plane due to its ability to compensate for phenomena including, but not limited to, burn down of the tips of the electrode and/or for disturbances caused by diffraction at the aperture of the paraboloid. For example, in a regular paraboloid (y"=2px) with p=l .25, introduction of a new electrode may result in p being about 1.05. If an electrode is used that adjusts itself to maintain the distance between the electrode tips ("adjustable electrode") and assuming that the electrodes burn down is 4 mm (z=4mm), p will increase to about 1.45. To compensate for this burn down, and here the change of p, and to generate nearly plane wave fronts over the life span of an electrode, a generalized paraboloid having, for example n= 1.66 or n=2.5 may be used. An adjustable electrode is, for example, disclosed in United States Patent 6,217,531.

[00288] Figure 4d shows sectional views of a number of paraboloids. Numeral 62 indicates a paraboloid of the shape y²=2px with p=0.9 as indicated by numeral 64 at the x axis which specifies the p/2 value (focal point of tϊie paraboloid). Two electrode tips of a new electrode 66 (inner tip) and 67 (outer tip) are also shown in the Figure . If the electrodes are fired and the tips are burning down the position of the tips change, for example, to position 68 and 69 when using an electrode which adjusts its position to compensate for the tip burn down. In order to generate pressure pulse/shock waves having nearly plane characteristics, the paraboloid has to be corrected in its p value. The p value for the burned down electrode is indicate by 65 as p/2 =1. This value, which constitutes a slight exaggeration, was chosen to allow for an eas ier interpretation of the Figure. The corresponding paraboloid has the shape indicated by 61 , which is wider than paraboloid 62 because the value of p is increased. An average paraboloid is indicated by numeral 60 in which p=1.25crn. A generalized paraboloid is indicated by dashed line 63 and constitutes a paraboloid having a shape between paraboloids 61 and 62. This particular generalized paraboloid was generated by choosing a value of n ≠ 2 and a p value of about 1.55cm. The generalized paraboloid compensates for different p values that result from the electrode burn down and/or adjustment of the electrode tips. [00289] Figure 5 is a simplified depiction of a set-up of the pressure pulse / shock wave generator (43) (shock wave head) and a control and power supply unit (4 1 ) for the shock wave head (43) connected via electrical cables (42) which may also include water hoses that can be used in the context of the present invention. However, as the person skilled in the art will appreciate, other set-ups are possible and within the scope of the present invention. [00290] Figure 6 is a simplified depiction of the pressure pulse / shock wave generator (shock wave head) having an electromagnetic flat coil 50 as the generating element. Because of the plane surface of the accelerated metal membrane of this pressure pulse / shock wave generating element, it emits nearly plane waves which are indicated by lines 51. In shock wave heads, an acoustic lens 52 is generally used to focus these waves. The shape of the lens might vary according to the sound velocity of the material it is made of. At the exit window 17 the focused wa.ves emanate from the housing and converge towards focal point 6.

[00291] Figure 7 is a simplified depiction of the pressure pulse / shock wave generator (shock wave head) having an electromagnetic flat coil 50 as the generating element. Because of the plane surface of the accelerated metal membrane of this generating element, it emits nearly plane waves which are indicated by lines 51. No focusing lens or reflecting lens is used to modify the characteristics of the wave fronts of these waves, thus nearly plane waves having nearly plane characteristics are leaving the housing at exit window 17.

[00292] Fig 8 is a simplified depiction of the pressure pulse / shock wave generator (shock wave head) having an piezoceramic flat surface with piezo crystals 55 as the generating element. Because of the plane surface of this generating element, it emits nearly plane waves which are indicated by lines 51. No focusing lens or reflecting lens is used to modify the characteristics of the wave fronts of these waves, thus nearly plane waves are leaving the housing at exit window 17. Emitting surfaces having other shapes might be used, in particular curved emitting surfaces such as those shown in Figs. 4a to 4c as well as spherical surfaces. To generate waves having nearly plane or divergent characteristics, additional reflecting elements or lenses might be used. The crystals might, alternatively, be stimulated via an electronic control circuit at different times, so that waves having plane or divergent wave characteristics can be formed even without additional reflecting elements or lenses.

[00293] Fig 9 is a simplified depiction of the pressure pulse / shock wave generator (shock wave head) comprising a cylindrical electromagnet as a generating element 53 and a first reflector having a triangular shape to generate nearly plane waves 54 and 51. Other shapes of the reflector or additional lenses might be used to generate divergent waves as well.

[00294] With reference to figures 10, 1 1 and 12 a schematic view of a shock wave generator or source 1 is shown emitting a shock wave front 200 from an exit window 17. The shock wave front 200 has converging waves 202 extending to a focal point or focal geometric volume 20 at a location spaced a distance X from the generator or source 1. Thereafter the wave front 200 passes from the focal point or geometric volume 20 in a diverging wave pattern as has been discussed in the various other figures 1 - 9 generally.

[00295] With particular reference to figure 10 an organ 100 is shown generally centered on the focal point or volume 20 at a location X₀ within the organ 100. In this orientation the emitted waves are focused and thus are emitting a high intensity acoustic energy at the location X₀. This location X₀ can be anywhere within or on the organ. Assuming the organ 100 is a tissue having a mass 102 at location X₀ then the focus is located directly on the mass 102. In one method of treating a tumor or any other type mass 102 these focused waves can be directed to destroy or otherwise reduce the mass 102.

[00296] With reference to figure 1 1 , the organ 100 is shifted a distance X toward the generator or source 1. The organ 100 at location X₀ being positioned a distance X-Xi from the source 1. This insures the organ 100 is impinged by converging waves 202 but removed from the focal point 20. When the organ 100 is tissue this bombardment of converging waves 202 stimulates the cells activating the desired healing response as previously discussed.

[00297] With reference to figure 12, the organ 100 is shown shifted or located in the diverging wave portion 204 of the wave front 200. As shown X₀ is now at a distance X₂ from the focal point or geometric volume 20 located at a distance X from the source 1. Accordingly X₀ is located a distance X + X₂ from the source 1. As in figure 10 this region of diverging waves 204 can be used to stimu late the organ 100 which when the organ is a cellular tissue stimulates the cells to produce the desired healing effect or response.

[00298] It will be appreciated that the apparatuses and processes of the present invention can have a variety of embodiments, only a few of which are disclosed herein. It will be apparent to the artisan that other embodiments exist and do not depart from the spirit of the invention. Thus, the described embodiments are illustrative and should not be construed as restrictive.

Claims

CLAIMS What is claimed is:

^ Apparatus for generating pressure pulse /shock waves characterized by: a pressure pulse/shock wave (PP/SW) source, a housing enclosing said PP/SW source, and an exit window from which wave fronts of waves generated by said PP/SW source emanate, wherein said wave fronts have nearly plane or divergent characteristics.

2. The apparatus of claim 1 , wherein said PP/SW source further characterized by: a pressure pulse/shock wave generating element for generating pressure pulses/shock waves, a focusing element for focusing said waves into a focus volume outside the focusing element, said apparatus further comprising a movab le elongated mechanical element having a longitudinal axis, wherein said focus volume is situated on or at said longitudinal axis, and wherein said movable elongated mechanical element is movable to extend to or beyond said focus volume so that wave fronts with divergent characteristics emanate from said exit window.

3.' Apparatus of claim 1 , wherein said PP/SW source comprises an electro hydraulic pressure pulse/shock wave generating element.

4. The apparatus according to claim 2, wherein said electro hydraulic pressure pulse/shock wave generating el ement comprising at least two electrodes, said PP/SW source further characterized by: a generalized paraboloid according to the formula y"=2px, wherein;

- x and y are carthesian coordinates,

- p/2 is a focal point measured from an apex of the generalized paraboloid, and

- n is about 1.2 <2 or 2< about 2.8, with n≠2, said electrodes being positioned within said generalized paraboloid, and wherein a spark between tips of said electrodes is, with about +/-5 mm of variance, generated at the focal point p/2 of the generalized paraboloid.

5. -The apparatus of claim 4, wherein burn down of the electrode tips (z) is compensated by the selection of (p-+/- z) and n so that the resulting generalized paraboloid has a configuration between a paraboloid defined by formula y²=2(p+z)x and a paraboloid defined by formula y²=2(p-z)x.

6: The apparatus of claim 4, wherein at least one of said electrodes is adjustable

1: The method of stimulating a substance comprises the steps of: activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the substance to the acoustic shock waves stimulating said substance wherein the substance is positioned within a path of the emitted shock waves and away from a geometric focal volume or point of the emitted shock waves.

8. The method of stimulating a substance of claim 7 wherein the emitted shock waves are divergent or near- planar or wherein the emitted shock waves are convergent having a geometric focal volume or point at a distance of at least X from the generator or source, the method further comprising positioning the substance at a distance lesss than the distance X from the source.

9. The method of stimulating a substance of claim 7 wherein the substance is a tissue having cells.

10. The method of stimulating a substance of claim 9 wherein the tissue is an organ of a mammal and wherein the mammal is a human or an animal.

1 1. The method of stimulating an organ comprises the steps of: providing an at least partial exposed organ or an access portal to an organ: activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the organ to the acoustic shock waves stimulating said organ wherein the organ is positioned within an unobstructed path of the emitted shock waves.

12. The method of stimulating an organ of claim 1 1 wherein the organ is a part of the vascular system, the nervous system, the urinary or reproductive system or the lymph node or pituitary systems.

13. The method of stimulating an organ of claim 1 1 further comprises the step of: transplanting the organ from a human or animal to a patient; and wherein the organ is exposed to shock waves after being transplanted into a patient or prior to being transplanted into a patient or both.

14. The method of claim 13 wherein the organ is a heart, a li ver or a kidney or a portion of a brain or any other organ or portion thereof.

15. The method of treatment for a tissue, organ or entire body of a patient prior to or after exposure to chemicals, radiation or both comprises the steps of: activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the tissue, organ or entire body to the acoustic shock waves stimulating said tissue, organ or body wherein the tissue, organ or body is positioned within a path of the emitted shock waves.

16. The method of treatment of claim 15 further comprises the step of: administering one or more medicaments prior, during or after subjecting the patient to acoustic shock waves.

17. The method of treatment of claim 16 further comprises the step of: directing radiation to a predetermined treatment region to eradicate cancerous cells or tissue or administering a treatment of chemotherapy to eradicate cancerous cells or tissue; or subjecting a tissue or organ to a surgical procedure to remove some or all of a cancerous growth or tumor.

18/ The method of treatment for a genital tissue or reproductive organ of an infertility or impotence diagnosed patient comprises the steps of: activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the genital tissue, reproductive organ or the entire reproductive region of the body to the acoustic shock waves stimulating said tissue, organ or body wherein the tissue, organ or body is positioned within a path of the emitted shock waves.

19-. The method of treatment of claim 18 further comprises the step of: testing the sperm count or viability of the male inferti lity or impotence diagnosed patient after exposure to one or more acoustic shock wave treatments.

20. 'The method of treatment of claim 18 further comprises the step of: testing the oocyte viability or count of the female infertility or impotence diagnosed patient after one or more acoustic shock wave treatments.

21. The method of treatment of claim 18 wherein the treated tissue has an indication of one or more pathological conditions including: infertility of oocyte or sperm, impotency, premenstrual syndrome, PMDD, stress urinary incontinence, polycystic ovarian disease, endometriosis, endometrial cancer, infertility, hormone imbalance, and tissue subjected to a variety of perturbations including hormone replacement therapy or chemical contraception.

22. The method of treating a host diagnosed with one or more biofϊlms, the biofilms having an outer t> arrier and an underlying colony of organisms comprises the steps of: locating a region or location of a resident biofilm; activating a pressure pulse or acoustic shock wave generating source; and emitting pressure pulse or acoustic waves and directing the pulses or shock waves to impinge the resident biofilm to destroy, fracture, fragment or otherwise open the outer barrier structure of the resident biofilm.

23. The method of claim 22 further comprises the step of: stimulating cells of a host to initiate a cellular response within the host when the host is a living being with organs and tissues having a cellular structure, the stimulated cells assist in absorbing or otherwise erad icating the biofilm.

24. The method of claim 22 wherein the region or location is part of a system including the cardiovascular, urological, reproductive, digestive, intestinal, neurological or periodontal.

25. The method of treatment for a periodontal tissue exhibiting a periodontal disease or periodontal condition in a diagnosed patient comprises the steps of: activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the periodontal tissue, or the entire periodontal region of the patient to the acoustic shock waves stimulating said tissue, wherein the tissue is positioned within a path of the emitted shock waves.

26. The method of treatment of claim 25 wherein the treated periodontal tissue has an indication of one or more pathological conditions including: a periodontal biofilm mass, periapical endodontic lesions, endo-perio lesions, gingivitis, inflammation of gingival tissue, periodontitis, progressive loss of ligament, cementum or alveolar bone support to teeth.

27. The method of claim 25 wherein the treated tissue has one or more conditions requiring treatment as follows: ridge augmentation for cosmetic, prosthetic or implantation of teeth; to assist osteoblastic and osteoclastic processes in orthodontia; regeneration of alveolar bone surrounding loose teeth implants regeneration of structures supporting the teeth including regeneration of structures supporting teeth including gingival, periodontal ligament, cementum and alveolar bone.

28. A method of enhancing the regeneration of injured nerves which comprises the step of: administering an effective exposure of pressure pulses or acoustic shock waves in a pulse or wave pattern to the zone of injury of the nerve during the regeneration process.

29. The method according to claim 28 wherein the nerve has been severed and a pulse or wave pattern is administered to the ends of the proximal and distal stumps.

30. The method according to claim 29 wherein a nerve graft is interposed between the stumps.

31. The method according to claim 30 wherein interfascicular nerve grafts are employed.

32. The method of enhancing the stimulation of neuronal cell growth or regeneration comprises the step of: adminstering an effective exposure of pressure pulses or acoustic shock waves in a pulse or wave pattern to stimulate neuronal cell growth or regeneration.

33. The method according to claim 32 wherein the administering is applied to a patient who has a pathological condition where neuronal repair can be facilitated including peripheral nerve damage caused by injury or disease such as diabetes, brain damage associated with stroke, and for the treatment of neurological disorders related to neurodegeneration, including Parkinson's disease, Alzheimer's disease and amyotrophic lateral sclerosis, multiple sclerosis and disseminated sclerosis.

34. The method of stimulating nerve or neurological organ regeneration comprises the steps of: activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the organ to the acoustic shock waves stimulating said organ wherein the organ is positioned within a path of the emitted shock waves.

35. The method of stimulating a plant substance comprises the steps of: activating a pressure pulse or an acoustic shock wave generator or source to emit pressure pulses or acoustic shock waves; and subjecting the plant substance to the pressure pulses or acoustic shock waves stimulating said substance wherein the substance is positioned within a path of the emitted pressure pulses or shock waves.

36. The method of stimulating an aquatic life form comprises the steps of: activating a pressure pulse or an acoustic shock wave generator or source to emit pressure pulses or acoustic shock waves; and subjecting the aquatic life form to the pressure pulses or acoustic shock waves stimulating said aquatic life form wherein the aquatic life form is positioned within a path of the emitted pressure pulses or shock "waves.

37. The method of treating a patient with an indication of one or more of the following: acne, AIDs, Alzheimer's disease, arthritis, bone cancer, burns, cancer, cellulitis, cirrhosis, cystic fibrosis, diabetes, emphysema, gout, HIV, leprosy, lupus, melanoma, myelodysplasia, nerve paraplegia, osteoporosis, periodontal diseases, pseudoarthrosis, rheumatism, scars, skin sarcomas, stomach ulcers or wounds; comprising the step of subjecting the patient to acoustic shock waves.

38. The method of treating a patient with an indication of claim 37 wherein the step of subjecting the patient to acoustic shock waves further comprises the steps of: activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the substance to the acoustic shock waves stimulating said substance wherein the substance is positioned within a path of the emitted shock waves and away from a geometric focal volume or point of the emitted shock waves.

39. A method of reducing or eliminating a mass within a substance comprises the steps of: detecting the presence of said mass in said substance, localizing said mass generally within said substance, and stimulating said substance by subjecting low energy divergent, planar or near planar acoustical waves or convergent focused acoustical waves wherein a geometric focal point or volume of the focused waves is not focused at the mass at least for a predetermined time during the step of stimulating the substance. 40 The method of reducing or eliminating a mass within a substance of claim 39 further comprises the step of focusing the geometric focal volume or point of convergent high energy acoustical waves on the mass

41 The method of reducing or eliminating a mass within a substance of claim 40 wherein the step of focusing convergent high energy acoustical waves on the mass generates cellular trauma within said mass