Patent Application
20190344094
This Invention patent application proposes a tri-diode used to generate a particular type of laser that can be used to treat all types of cellular lesions, both in humans and in other animals. The invention can be applied to any age of patient and any lesion condition.
The type of laser produced by the tri-diode object of this Invention patent application is not restricted to musculoskeletal lesions, and may also be used in cardiology, rheumatology, pneumology, etc., in other words, all tissues with active lesions and inflammation.
This invention patent application proposes and features an original tri-diode designed and developed for the field of laser therapy, which innovates by featuring a combination of three specific molecules, namely: zinc, phosphor (or phosphate) and aluminum.
The combination of the three aforementioned molecules ensures a unique and exclusive treatment form for cellular regeneration. The unprecedented continuous and useful (or final) power ranging from 1.2 W to 1.5 W in each diode generates a total of 3.6 W up to 4.5 W of continuous power at the light outlet of the beam tip, at a 780-808 nm wavelength spectrum.
This invention patent application also proposes and provides an original accessory for the equipment which is incorporated to the tri-diode, called “on-site tip”, ensures laser application directly onto the lesion through a catheter (intracath/epidural) already installed in the patient. In addition, a technique that allows the tip to be sterilized was developed, as well as ensuring that said tip is disposed of. An original glass cooling system was also developed at the tip of the light beam outlet, maintaining temperatures between 1.5° C. and 2.2° C.
The laser therapy world market for the health care sector is mainly comprised of equipment with a basic structure pattern: same standard diodes (AsGa, AsGaAl AsGaAlIn, AsGaAlInP), power variations (5 mW-2 W) and in continuous (up to 400 mW) and pulsed (above 400 mW) modes.
In this field, they are built at the 630-904 nm range, 5 mW-250 mW power, continuous or pulsed mode and with a single diode, with AlGaInP or GaAlAs being the most common.
As for the laser therapy field, equipment units from the state of the art were unsuccessful in proving cellular regeneration. Instead, there are results based on reports on pain relief (VAS—Visual Analog Scale or Borg scale”, both subjective, since they are based on the patient's assessment), but none with conclusive results.
In studies carried out by the Applicant herein, it was proven that increasing power of a market equipment to 500 mW and changing the application form, proven regeneration results may be attained through nuclear magnetic resonance. Such an example were the clinical reports for full ligament injuries (torn) before treatment and, after application of said laser, the nuclear magnetic resonance reports have shown that the ligaments were “normal”, in other words, fully regenerated to normality. The only aspect yet to be improved is the excessive time it takes to obtain said results, as it took 18 months to be attained due to equipment limitations.
Thus, if an equipment unit caters for a century of concept stagnation, full cellular regeneration may be attained in up to 4 months for acute lesions (maximum time for physiological regeneration), 9 months for chronic lesions (physiologically non-regenerative) and 12 months for degenerative lesions (impossible nowadays in any treatment type, even surgical).
In addition, equipment manufacturers consider that: when applying radiation, a “light spread on the tissue” takes place, in other words, loss of energy. This would further increase the loss of light deposited in the tissue, decreasing the potential of induction to cellular regeneration by laser. This leads to their assumption that the light is not coherent at the moment it reaches the tissue, as it is lost due to this effect, without constant focus on application.
Problems with Diodes in the Market
After Louis de Broglie (1897) came up with the wavelength theory in order to describe the magnitude of light radiation, all scientists that entered the laser field in health care have corroborated this theory, refraining from using other theories in the areas of physics and radiation. Thus, laser therapy developers and researchers have stagnated in time, and the wave, or wavelength, has become they key to the emission of radiation in the lasers from the health care sector.
When Albert Einstein (1955) released the corpuscular theory, or dual nature of light, he shortly argued that this corpuscular theory is associated to absorption and light emission phenomena. The photoelectric effect describes that the light interacts with the material and, as materials behave like particles, such as a molecule. This theory was reaffirmed by Arthur Compton, as the light interacts with the material or with subject, not only behaving as a physical magnitude, wavelike, but also as a molecular interaction between them.
Thus, when this physical theories revealed that the light interacts with matter-molecule, they described its interaction form only with materials, but not biological tissue, with said theory not being completely valid within a living organism.
Therefore, energy applied onto a biological tissue will cause widely different reactions than those found in a material, as these reactions will unleash chemical and biological effects, intrinsically to cells, local tissues and, lastly, systems and organs. And, in order to attain the objectives of cellular regeneration, we should initially be based in the physiology, which describes that the three main molecules responsible for cellular regeneration are:
That said, these three molecules are required to form a cellular regeneration induction radiation.
Now, it may be clearly understood that precisely all existing equipment nowadays were not manufactured to induce cellular regeneration, but to interact with materials instead of biological tissues. This has created a plethora of ineffective and discredited equipment, further limiting the investment and researches on the subject (Rev Bras Med Esporte—Vol. 22, No. 1—January/February 2016).
Problems with Wavelengths (nm) of the Market
Literature proves that the ideal spectral band for cellular activity is between 630-904 nm. For each tissue, there is a specific range, for example: 808-904 for bones, between 680-808 nm for soft tissue and 630-680 nm for skin, such as understood upon observation of
Its use depends on the focus of each therapist, but the most indicated for the “Biological Window of Cellular Regeneration [Janela Biológica de Regeneração Celular]©” is found within the 780-808 nm spectrum. Since, when specifically enclosing a spectrum, it would be economically unfeasible to manufacture an equipment unit for each tissue type. Therefore, this spectrum encompasses a regeneration potential window for all bone and muscular tissues, enabling new equipment in the wide usage aspect.
Problems with Equipment Power in the Market
Current laser therapy equipment in the home market are up to 100 mW in continuous format. International equipment with power above 250 mW-3 W are under pulsed programming, with extremely high frequency pulses as to not cause burns, since continuous programming equipment above 450 mW already cause burns.
The energy deposited in the tissue must be, at least, 3 times higher than the lesion, for the laser light to be able to overcome the injury when applied to the tissue. Therefore, all said equipment are mathematically inefficient, providing lower energy in the tissue regarding the amount needed to beat the injury.
When the light is shed into the tissue, it absorbs the energy in order to distribute its effects through the cells, as a “Cell Triage [Triagem Celular]©” method: the least injured tissue will absorb more energy to keep healthy, the most injured requires a higher energy potential, and stays behind. Thus, in order to prevent the lesion from spreading, the tissue chooses to consider the lesion “lost”, leaving it for last, and the other tissues become a priority in order to keep local homeostasis. This way, current laser equipment emits much lower energy compared to tissue requirements. This is why cellular regeneration cannot be proven.
Based on simple mathematics, an equipment that generates power, at least, above 1.2 W to 1.5 W applied directly to the tissue would be required. However, in order to attain this, the same problem experienced by all equipment nowadays would be faced: heating, and this single factor limits the entire therapy.
Thus, all laser therapy equipment in the world are unable to prove cellular regeneration with concrete and objective results, none was able to issue a nuclear magnetic resonance report on time, before and after the treatment, with any conclusive results. Therefore, there is no equipment in the world that is proven to be regenerative, as they only suggest an improvement in pain levels=subjective results.
Problems with Limitations on Topical Tips
Another major problem of use equipment is their topical exclusiveness, as even if the power was increased, treatment would be restricted to minor-moderate lesions. To regenerate deep, extensive or severe lesions, chronic or degenerative lesions, the “Cell Triage”© theory must be based on. A dosage-stimulation-regeneration effect must be created, capable of overcoming the absorption compensation of nearby tissues that sustain the lesion. This way, if the laser could be directly applied over the focus of the lesion (in loco), eliminating all tissue barriers and preventing “Cell Triage”©, the original lesion would be regenerated, stopping the circular stimulation of inflammation-fibrosis-inflammation.
Summarized Description of the Invention
This invention patent application proposes a tri-diode for laser therapy, which innovates by featuring a combination of three specific molecules, namely: zinc, phosphor (or phosphate) and aluminum, capable of inducing cellular regeneration and even is deployed in tissue engineering to help produce autologous tissues. The tri-diode referred herein is mounted in an encapsulation, afterwards fed to a glassware system, where two ampoule-shaped components are included, with similar format to a test tube, so that one ampoule is placed inside the other, both closed by a sealing connector that allows space between them, through which distilled water is flown through as a cooling fluid, entering the glassware system through an inlet tube and (removing heat in the process) through the outlet tube. The removed heat is due to the light generation of the laser, and is removed by a cooling system, which will be included by a software-controlled temperature system.
One of the objectives of this invention patent application is proposing a tri-diode up to 1.5 W (energy directly deposited in the tissue) for laser generation specifically developed for use in cellular regeneration, and may also be used in:
a) Acute lesions: traumas;
b) Chronic lesions;
c) Degenerative lesions;
d) Any inflammatory process: heart attacks, strokes, Alzheimer, Parkinson, etc.
e) Tissue engineering: tissue production for transplants and grafting.
Based on the use of the new equipment proposed in this invention patent application, the Applicant herein expects to attain the following effects:
1. Active inflammation:
a. 100% of cellular regeneration in light, moderate and severe lesions;
I. Regeneration in up to 4 months of application;
b. 80% of cellular regeneration in chronic and degenerative lesions;
I. Regeneration in up to 12 months of application.
This Invention Patent, which is proposed based on the foregoing, will be thoroughly described below with reference to the following figures, in which:
The subject comprised in this Invention patent application considers the assembly of molecularity with the most known and used diodes in the market. Thus, the probability of mixture of 26 possibilities of Al+P and ZN is featured.
The accurate measurements of this encapsulation, mirroring and lenses are dependent on the diodes chosen, since there are countless, in varied shapes and sizes, likewise, countless possibilities are featured, such as expressed in Table 1 below, showing the combination possibilities for the mixing diodes:
Firstly, and as illustrated by
In said
Between the end light and the lenses system, a first basic cooling cluster system 10 will be placed, working on the air cooling in order to neutralize the heat production that may cause damage to the parts.
It is expected that power losses occur throughout the process (“dead spaces”), but the power of each diode 100 that should be 1.5 W (for a total of 4.5 W when adding the three diodes 100 together) is estimated to be sufficient so that the light produced in the optic fiber outlet 14 is obtained at a minimum value, to be deposited directly onto the tissue, of between 1.2 W and 1.5 W.
The light then passes through additional collimation lenses 11/connector attachment 12 systems for final emission of pure light. Depending on the sizes and spatial differences between them, precisely placed mirrors will be required within this encapsulation, as to prevent light loss inside the arrangement, until it leaves through the optic fiber 14.
After the light collimation, an SMA 905 connector must be provided on the laser light outlet 12. From this point on, the 600 um optic fiber is provided (F600). This entire assembly is closed.
Said
This new arrangement, unique in its class, shall open up a new variety of wavelength combinations: yellow/orange/red/infrared (400-830 nm by use of Al: AlSb/AlAs/AlAsGa; of P: InP/GaP/GaInP/AsGaInP) and blue/green (400-520 nm by use of ZnSe and ZnO). In any wavelength, according to the requirements of each applicant, but the most indicated wavelength for cellular regeneration is between 780-808 nm.
This invention patent provides a glassware and cooling system, with said glassware system being shown in
Since the ideal power is between 1.2 W and 1.5 W, and even with an air-cooling system placed directly on the encapsulation, a high amount of heat is still placed on the tissue.
If, on one hand, the temperature cannot be increased by more than 2.2°, on the other hand, it cannot be lower than 1.5°, as the desired effect over the “Biological Window of Cellular Regeneration©” will not be obtained.
Also, the penetration with the topical tip was unable to surpass 5 cm, a drawback that was solved by the development of an accessory: a minimally invasive tip. A glassware system that envelops the optic fiber 14 and carried out cooling through a basic cooling system using distilled water.
The glassware system comprises two ampoules indicated by reference numbers 15 and 16, with the smaller diameter ampoule referenced as 15 and the larger diameter ampoule referenced as 16, both made of glass, preferably with similar shape to test tubes (total length: ampoule 16 is 15 cm), so that ampoule 15 is placed inside ampoule 16 with an 80 μm gap between them, as per
Each glassware ampoule shall have 2 μm, therefore, 4 μm worth of glassware. The cylindrical tip will be the berth 17 (support/limit) or end point for the optic connector 14 (indicated in a dashed line on
The optic fiber 14 will be introduced in the glassware, placed and fixed exactly at the tip of the berth 17 and the glassware (15 and 16) will function as a capillary system, allowing access of light coming from the laser equipment 23.
The optic connector 14 is attached to the laser 23 through an optic connector 22, placed centrally at the end of the glassware system, more specifically at the center of the sealing connector 19, as may be seen in FIG. 6.
In this case, the removal of the heat produced by the laser, regarding the glassware system, will be enabled by the flow of cooled water indicated by the flow arrows 28. Cooling will be performed by the aforementioned external cooling equipment 24 which is also normally used in surgical environments, featuring a connection with the aforementioned density deviation capture laser system 27 on the water inlet 25 and water outlet tubes 26, ensuring full monitoring regarding any water loss or breaks/cracks to the glassware system 15-16 through thermal spectrophotometry.
The density deviation capture laser system 27 may be a market model, since there are many that already deliver the feedback and heat control system, maintaining a programmed temperature adjustment. Any of said equipment will work perfectly to keep temperature and distilled water 28 flow speed required to maintain the programmed cooling in the 1.5° to 2.2° degrees range (Celsius).
The glassware system (15-16) I designed for compactness, in order to allow placement and fixing to an intracath/epidural catheter needle above the measurement of 26 G1 indicated by number reference 29, and as schematically shown in
This measurement may vary according to the manufacturer; therefore, thicknesses may vary. Immediately after full assembly, the on-site tip accessory 31 will be stored in a package 30 suitable for sterilization by ethylene oxide (
The on-site tip 31 will be connected with a simple plug connector to the cooler 24 and the laser equipment 23.
For better security, a grip handle 32 is provided, such as shown in
The On-site tip 31, exclusively shown in
Within the scope of this invention patent application, it should be considered that every 1.2 W/A=1.2V=1200 mV, and also considering that energy production by light takes place through a photon outlet and, consequently, an electron, its electric charge capacity will be negative. So, when the laser light is emitted, it is negative, and considering that the cell depolarization potential (cell membrane) is between −70 mV (neurons) and −90 mV (membrane rest potential), at least 3 times this amount would be required to activate the cell. Exactly for this reason, laser equipment in the market are unable to activate cellular regeneration, since they do not emit the minimum energy required to activate one cell, let alone the amount of cells per mm2 (50-200 cells per mm2, depending on type, as there are size variations).
Thus, at least 1.2 W/cm2 to 1.5 W/cm2 of power would be required to overcome the electric potential difference in a lesion (according to Machado 2016©, the minimum energy potential calculation to overcome a lesion would be 3 times the amount of the membrane depolarization potential, which is −90 mV).
As always, energy losses are a certainty, for 2 factors:
1. Repair/Degeneration Potential: at least times (repair) and 4 times (degeneration) the membrane depolarization amount.
2. Cell Triage©” Potential: considering that the light inlet is coherent, cells move constantly, and light absorption is different at each point of the tissue, energy losses will be ongoing according to the light penetration form in the tissue. The cell triage process takes place when intact cells give room for movement towards the light by the injured cells, in other words, priority of absorption will be given by the injured tissues. To understand how this light penetrates the tissue, firstly the spatial geometry of the human body must be considered: using the planes and axes of anatomy (
3. In other words, this triage distributes the light over the tissue, according to need. But, at the same time, this distribution distributes the light and does not apply it on the desired location, which is the most important lesion. When there is a lesion, it will overburden other tissues to sustain itself, turning into a vicious cycle of lesion-overburden-lesion. Overburdened cells are priority in cell triage, as the tissue understands that, if they were healthy, they would be able to withstand the additional burden, preventing the lesion from spreading. Thus, our focus remains on the final location: the lesion. This loss described by the literature as “spreading”, as this system was not yet understood. The energy loss by “Cell Triage” © is 10 times the membrane depolarization potential.
Therefore, the minimum energy loss will be:
Repair
Energy Loss (PE)=(Repair Potential (PR)+“Cell Triage” potential (PTC))×Cell Depolarization potential (PDC) in mV
PE=(3+10)×−90 (mV)
PE=13×−90 mV=−1,170 mV=1,170V when converted to W=1,170 W
Degeneration
Energy Loss (PE)=(Repair Potential (PR)+“Cell Triage” potential (PTC))×Cell Depolarization potential (PDC) in mV
PE=(4+10)×−90 (mV)
PE=13×−90 mV=−1,260 mV=1,260V when converted to W=1,260 W
This is why power needs to be increased to 1.2 W/cm2 in order to begin stimulation of cellular regeneration. Nevertheless, several factors will affect energy loss, such as additional lesions and respective times. Therefore, at least 1.2 W up to 1.5 W of power is required.
Cooling
For this reason, with power ranging from 1.2 W to 1.5 W, also considering that the core body temperature is between 36° C. and 37.5° C. with a ±0.6° C. variation carried out through efficient homeostatic mechanisms in order to maintain organic chemical reactions within compatible normality standards, increases in temperature produced by emission and concentration of laser radiation must be controlled. Heat values above the target value between 1.5° C. and 2.2° C. will certainly be featured in order to stimulate cellular regeneration.
This patent application also provides a basic software-controlled cooling or refrigeration system programmed to maintain temperature between 1.5° and 2.2°. A standard diode signaling temperature system 37, such as shown in
This tri-diode equipment for laser therapy, in its full setup, is featured on
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2017 000116 4 | Jan 2017 | BR | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/BR2017/050370 | 12/5/2017 | WO | 00 |
