Patent Application
20240269031
The present invention relates to a treatment for delivering acoustic shock waves or pressure pulses to gum tissue non-invasively and methods used in conjunction with the device to treat the gum tissue for sensitivity and inflammation.
Gum tissue is naturally soft and sensitive. Sensitive gums can result in soreness, swelling, redness, bleeding or bad breath.
There are many possible causes of gum soreness or sensitivity, the following are just some of the common causes. Gingivitis is a mild form of gum disease that's fairly common and causes inflammation, redness, and irritation of the gum tissue. Periodontitis is a more serious form of ongoing gum disease that can develop from untreated gingivitis. Hormonal changes also cause gum sensitivity. Various dental appliances can also cause irritation and sensitivity of the gums. Forceful or incorrect brushing or flossing is another common cause of gum sensitivity.
In the present invention, a non-invasive low energy shock wave treatment is disclosed overcoming gum sensitivity even in the absence of diseases like gingivitis or more serious periodontitis.
In U.S. Pat. No. 7,497,835 B2 entitled Method of Treatment for and Prevention of Periodontal Disease, the inventors found the use of acoustic shock waves would destroy and inhibit periodontal biofilms. These biofilms are difficult to treat using drugs or medicines. In this patent, it is understood that treatments of such diseases generally are made easier when the disease condition has occurred. An increase in oral bacteria count is tested. In the present invention, otherwise healthy gums and teeth can exhibit sensitivity to “hot” or “cold” foods or drinks and are particularly painful and the treatment using acoustic shock waves can reduce this sensitivity.
A method of treatment for a sensitive gum tissue exhibiting a sensitivity to touch, heat or cold conditions in a diagnosed patient has the steps of: activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the sensitive gum tissue of the patient to the acoustic shock waves stimulating said gum tissue, wherein the gum tissue is positioned within a path of the emitted shock waves. The emitted shock waves are emitted in one of convergent, divergent, planar or near planar wave patterns. The emitted shock waves when emitted in a convergent pattern have one or more geometric focal volumes of points at a distance of at least X from the generator or source. In this case, the method further has the step of positioning the gum tissue at a distance at or less than the distance X from the source.
The method of treatment further can include the step of administering one or more medicaments prior, during or after subjecting the patient to acoustic shock waves and testing the sensitivity of the treated gum tissue of the diagnosed patient before and after exposure to one or more acoustic shock wave treatments.
The method of treatment further has the step of numbing and desensitizing the gum tissue wherein the treated gum tissue has no indication of periodontal disease including any 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. The treated gum tissue activates or otherwise stimulates stem cells or release of cellular growth factors in the oral structure effecting a tissue repair or tissue regeneration.
In another embodiment, a method of treating a patient exhibiting sensitivity of gum tissue to reduce pain and inflammation using pressure pulses or shock waves has the steps of: placing an applicator head of an acoustic shock wave or pressure pulse generator or source near the gum tissue of the patient; coupling the applicator head directly or indirectly to an exposed surface of the skin near the gum tissue; and activating the generator or source to emit pressure pulses or acoustic shock waves to the gum tissue exhibiting pain and inflammation to reduce the pain and inflammation, wherein the emitted pressure pulses or acoustic shock waves are transmitted in a pattern passing through the gum tissue and the emitted pressure pulses or acoustic shock waves pattern impinges the gum tissue.
The pressure pulse is an acoustic pulse which includes several cycles of positive and negative pressure. The pressure pulse has an amplitude of the positive part of such a cycle should be above 0.1 MPa and the time duration of the pressure pulse is from below a microsecond to about a second. The rise times of the positive part of the first pressure cycle is in the range of nanoseconds (ns) up to some milliseconds (ms). Preferably, the acoustic shock waves are very fast pressure pulses having amplitudes above 0.1 MPa and rise times of the amplitude being below 1000 ns wherein the duration of the shock wave is typically below 1-3 microseconds (us) for the positive part of a cycle and typically above some microseconds for the negative part of a cycle.
The method preferably subjects the gum tissue to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the cells stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of hemorrhaging caused by the emitted waves or pulses in cells wherein the cells are positioned within a path of the emitted shock waves or pressure pulses; and away from any localized geometric focal volume or point of the emitted shock waves wherein the emitted shock waves or pressure pulses either have no geometric focal volume or point or have a focal volume or point ahead of the cells or beyond the cells thereby passing the emitted waves or pulses through the cells while avoiding having any localized focal point within the cells.
The emitted pressure pulses or shock waves are convergent, divergent, planar or near planar and the pressure pulse shock wave generator or source is based on electro-hydraulic, electromagnetic, piezoceramic or ballistic wave generation having an energy density value ranging as low as 0.00001 mJ/mm2 to a high end of below 1.0 mJ/mm2.
The method subjects the gum tissue directly to the acoustic shock waves having a low energy density of less than 1.0 mJ/mm2 per shock wave stimulates said cells or gum tissue wherein the cells or gum tissue is positioned directly within a path of the emitted pressure pulses or acoustic shock waves in the absence of any focal point or if a focal point exists, the cells or gum tissue being treated is positioned away from any focal point and the energy density is selected to avoid any cell damage to the cells or gum tissue or the gum tissue is stimulated by accelerating or increasing cell growth or regeneration wherein the administering is applied to the patient who has a pathological condition of the gums exhibiting damage caused by gum disease, injury or inflammation, any one of which has caused pain and inflammation which is reduced by the treatment or the gum tissue is stimulated by accelerating and increasing cell tissue growth or regeneration or repair in addition to reducing gum tissue swelling and pressure and inflammation in the absence of any pathological condition and wherein the cell or gum tissue is from a mammal which is a human or an animal.
In additional embodiments, a method of treating a patient exhibiting sensitivity of gum tissue to reduce pain and inflammation using pressure pulses or shock waves has the steps of: placing an applicator head of an acoustic shock wave or pressure pulse generator or source near the cheek of the patient or near a gum or mouth reflexology zone of a patient; coupling the applicator head directly or indirectly to an exposed surface of the skin near the cheek; and activating the generator or source to emit pressure pulses or acoustic shock waves to the gum tissue exhibiting pain and inflammation to reduce the pain and inflammation.
“Adrenergic receptor”, the adrenergic receptors or adrenoceptors are a class of G protein-coupled receptors that are targets of many catecholamines like norepinephrine (noradrenaline) and epinephrine (adrenaline) produced by the body, but also many medications like beta blockers, β2 agonists and α2 agonists, which are used to treat high blood pressure and asthma for example. Many cells have these receptors, and the binding of a catecholamine to the receptor will generally stimulate the sympathetic nervous system (SNS). SNS is responsible for the fight-or-flight response, which is triggered for example by exercise or fear causing situations. This response dilates pupils, increases heart rate, mobilizes energy, and diverts blood flow from non-essential organs to skeletal muscle. These effects together tend to increase physical performance momentarily.
“Aerobic” living, active, or occurring only in the presence of oxygen.
“Alveolar” Alveolar bone the part of the jaw that surround the roots of the teeth. Alveolar process the curving part of the jaw into which the teeth are rooted. Alveolus the socket in the alveolar bone into which the tooth's root fits.
“Anaerobic” living, active, or occurring in the absence of free oxygen.
“Cementum” the very thin, bonelike structure that covers the root of the tooth.
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.
“Debridement” the surgical removal of lacerated, devitalized, or contaminated tissue. This includes removal of tartar beneath the gum and scaling and root planing and in more advanced conditions may necessitate periodontal surgery or complete debridement of the roots and re-contouring of the hard and soft tissue to arrest the disease process or to restore lost bone.
“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.
“Endo-perio lesions” lesions due to inflammatory products found in varying degrees in both the periodontium and the pulpal tissues.
“Extracorporeal” means occurring or based outside the living body.
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 yn=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.
“Gingivitis” inflammation of gingival tissue without loss of connective tissue. The earliest sign is bleeding gum. Gingiva soft tissues overlying the crowns of unerupted teeth and encircling the necks of those that have erupted. Gingival Hyperplasia an overgrowth of gingival tissues.
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.
“Periapical endodontic lesions” lesions in the area at the end of the roots of the teeth.
“Periodontitis” inflammation of the supporting structures of the tooth, including the gum, the periodontal ligament, and the jawbone.
“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 wave 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.
A “pressure pulse” according to the present invention is an acoustic pulse which includes several cycles of positive and negative pressure. The amplitude of the positive part of such a cycle should be above about 0.1 MPa and its time duration is from below a microsecond to about a second. Rise times of the positive part of the first pressure cycle may be in the range of nanoseconds (ns) up to some milliseconds (ms). Very fast pressure pulses are called shock waves. Shock waves used in medical applications do have amplitudes above 0.1 MPa and rise times of the amplitude can be below 1000 ns, preferably at or below 100 ns. The duration of a shock wave is typically below 1-3 microseconds (us) for the positive part of a cycle and typically above some microseconds for the negative part of a cycle.
“Shock Wave”: As used herein is defined by Camilo Perez, Hong Chen, and Thomas J. Matula; Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, 1013 NE 40th Street, Seattle, Washington 98105; Maria Karzova and Vera A. Khokhlovab; Department of Acoustics, Faculty of Physics, Moscow State University, Moscow 119991, Russia; (Received 9 Oct. 2012; revised 16 Apr. 2013; accepted 1 May 2013) in their publication, “Acoustic field characterization of the Duolith: Measurements and modeling of a clinical shock wave therapy device”; incorporated by reference herein in its entirety.
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.
The invention will be described by way of example and with reference to the accompanying drawings in which:
With reference to
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The ultrasonic wave pattern shown in
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As illustrated, the device shown is an electrohydraulic acoustic shock wave generator, however, other devices that generate acoustic shock waves can be used. Ultrasonic devices may be considered, but there is no data to support a sinusoidal wave form would work and therefore not considered as effective as the asymmetric wave generators. The acoustic shock waves activate a cellular response within the reflexology treatment site. This response or stimulation causes an increase of nitric oxide and a release of a variety of growth factors such as VEGF. As shown, the flexible membrane is protruding outward and the applicator 43 has been filled with fluid, the transmission or emission of acoustic shock waves 200 is directed towards the reflexology zone 160. In order to accomplish a good transmission, it is important the flexible membrane be pressed against the patient's P skin Ps and as indicated coupling gels may be used. The zone 160, as illustrated, is the reflexology zone for the pancreas which is a region of the foot PF located in a middle of an inside arch of each foot. By transmitting the shock waves 200 to the zone 160, is it believed that a modulation of the secretions from the pancreas can be made. This modulation or adjustment is achieved by transmitting the acoustic waves 200 at low energy directly onto the zone 160.
With reference to
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It is believed that modulation and beneficial adjustment can be achieved at reflexology zones for stimulating, modulating or adjusting reflexology zones for glands or organs such as the liver, kidney or any of those indicated in
This apparatus, in certain embodiments, may be adjusted/modified/or the complete shock wave head or part of it may be exchanged so that the desired and/or optimal acoustic profile such as one having wave fronts with focused, planar, nearly plane, convergent or divergent characteristics can be chosen.
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, planar, nearly plane, convergent or divergent characteristics can be chosen.
A change of the wave front characteristics may, for example, be achieved by changing the distance of the exit acoustic window relative to the reflector, by changing the reflector geometry, by introducing certain lenses or by removing elements such as lenses that modify the waves produced by a pressure pulse/shock wave generating element. Exemplary pressure pulse/shock wave sources that can, for example, be exchanged for each other to allow an apparatus to generate waves having different wave front characteristics are described in detail below.
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.
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.
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.
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.
As the person skilled in the art will also appreciate that embodiments shown in the drawings are independent of the generation principle and thus are valid for not only electro-hydraulic shock wave generation but also for, but not limited to, PP/SW generation based on electromagnetic, piezoceramic and ballistic principles. The pressure pulse generators may, in certain embodiments, be equipped with a water cushion that houses water which defines the path of pressure pulse waves that is, through which those waves are transmitted. In a preferred embodiment, a 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.
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 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. Bleeding internally causes an increase in fluid pressure which can lead to increased damage. This can be completely avoided in this treatment protocol.
The fact that some if not all of 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 inside the mouth 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.
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 device 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 tissue directly 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 VEGF and other growth factors while simultaneously germicidally attacking the degenerative tissue or infectious bacteria at the target site.
Due to the wide range of beneficial treatments available it is believed preferable that the optimal use of one or more wave generators or sources should be selected on the basis of the specific application. 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.
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.
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.
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/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.
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 like the gums.
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.
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 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-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 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.
The method of treatment for gum tissue exhibiting sensitivity in a diagnosed patient is disclosed. The method has the steps of activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the gum tissue of the patient to the acoustic shock waves stimulating said gum tissue, wherein the gum tissue is positioned within a path of the emitted shock waves. The emitted shock waves are either convergent, divergent, planar or near planar. Alternatively, the emitted shock waves can be convergent having one or more geometric focal volumes or points at a distance of at least X from the generator or source, the method further comprising positioning the organ at a distance at or less than the distance X from the source.
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.
Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described which will be within the full intended scope of the invention as defined by the following appended claims.
